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Medical Patent Abstract
Various present invention devices enable adherence to requirements
for medical items. A medical item of the present invention includes
a monitoring or data recording device to monitor and/or record medical
solution conditions. The device may further include indicators to
indicate compliance of the medical solution with prescribed requirements
(e.g., manufacturer, medical standard or regulation, etc.). The
medical item may alternatively include a barcode or transponder
to uniquely identify the medical item to a thermal treatment system
measuring and storing conditions in a central database. The present
invention further includes various thermal treatment systems that
monitor medical items for prescribed requirements and display the
monitored parameters to medical personnel. In addition, the present
invention may place time stamp information on medical items to enable
determination by medical personnel of compliance with prescribed
requirements.
Medical Patent Claims
What is claimed is:
1. A temperature control system for thermally treating medical
items to desired temperatures comprising: a temperature control
unit including: a unit housing; a thermal treatment unit disposed
within said housing to thermally treat at least one medical item;
a controller to facilitate entry of a desired temperature and to
control a thermal output of said thermal treatment unit to thermally
treat said at least one medical item to said entered desired temperature;
and a usage control unit to confine operational usage of said temperature
control unit by a user for thermally treating said at least one
medical item to be within an authorized use interval for said user
defined by usage parameters associated with said user, wherein said
usage control unit disables operation of said temperature control
unit by said user for thermally treating said at least one medical
item outside said authorized use interval associated with said user
and said usage parameters include at least one of a time interval
for said operational usage of said temperature control unit to thermally
treat said at least one medical item, a quantity of thermal cycles,
a quantity of medical items to thermally treat, and a duration a
medical item remains within said system.
2. The temperature control system of claim 1, wherein said thermal
treatment unit heats said at least one medical item.
3. The temperature control system of claim 1, wherein said thermal
treatment unit cools said at least one medical item.
4. The temperature control system of claim 1, wherein said temperature
control unit further includes: at least one temperature sensor to
measure a temperature of a corresponding medical item, wherein said
controller controls said thermal output of said thermal treatment
unit to thermally treat said at least one medical item to said entered
desired temperature based on said temperature measured by said corresponding
temperature sensor.
5. The temperature control system of claim 4, wherein said temperature
control unit further includes: a timer to measure residence time
of each medical item thermally treated by said thermal treatment
unit.
6. The temperature control system of claim 1 further including:
an information storage device to store said usage parameters, wherein
said information storage device is provided by said user to said
temperature control unit.
7. The temperature control system of claim 6, wherein said information
storage device includes at least one of a card, a memory device,
a removable storage device, an integrated circuit and a chip.
8. The temperature control system of claim 6, wherein said usage
control unit includes: a system interface to transfer information
with said information storage device.
9. The temperature control system of claim 8, wherein said system
interface collects information pertaining to at least one of medical
item conditions, system conditions, time, corresponding temperature
information for at least one medical item, patient information,
user information, doctor information and facility information.
10. The temperature control system of claim 9, wherein said system
interface stores said collected information on said information
storage device.
11. The temperature control system of claim 10, wherein said information
storage device is provided to a service provider to retrieve said
stored information from said information storage device and generate
a report for said user.
12. The temperature control system of claim 10 further including:
an external interface to transfer information with said information
storage device; and an external processing device coupled to said
external interface to enable transfer of information with said information
storage device.
13. The temperature control system of claim 12, wherein said external
processing device enables an authorized user to perform at least
one of retrieval of information from said information storage device
in the form of a report and adjust said usage parameters stored
on said information storage device to enable further use of said
temperature control unit.
14. The temperature control system of claim 12 further including:
a server system in communication with said external processing device
to receive and store said information stored on said information
storage device, wherein said server system includes a web site accessible
by said user to perform at least one of retrieval of information
from said information storage device in the form of a report and
adjust said usage parameters stored on said information storage
device to enable further use of said temperature control unit.
15. The temperature control system of claim 1, wherein said temperature
control unit further includes: a communications device to facilitate
communications with an external device and to collect information
pertaining to at least one of medical item conditions, system conditions,
time, corresponding temperature information for at least one medical
item, patient information, user information, doctor information
and facility information.
16. The temperature control system of claim 15, wherein said external
device includes a server system to transfer information with said
communications device and to store said collected information.
17. The temperature control system of claim 16, wherein said server
system communicates with said communication device via a network.
18. The temperature control system of claim 16, wherein said server
system includes a web site accessible by said user via an end user
device to perform at least one of retrieval of said collected information
in the form of a report and adjustment of said usage parameters
to enable further use of said temperature control system.
19. The temperature control system of claim 16, wherein said communications
device transfers said collected information to said server system
in real time to enable said user to access said transferred information
via an end user device to remotely monitor a status of said temperature
control unit.
20. The temperature control system of claim 19, wherein said end
user device provides at least one alarm to indicate conditions exceeding
prescribed requirements.
21. The temperature control system of claim 19, further including
a plurality of said temperature control units, wherein said communications
device of each temperature control unit transfers said collected
information to said server system in real time to enable said user
to access said transferred information via an end user device to
remotely monitor a status of said temperature control units.
22. A temperature control system for thermally treating medical
items to desired temperatures comprising: a temperature control
unit including: a unit housing; a thermal treatment unit disposed
within said housing to thermally treat at least one medical item;
a controller to facilitate entry of a desired temperature and to
control a thermal output of said thermal treatment unit to thermally
treat said at least one medical item to said entered desired temperature;
and a usage control unit to control usage of said temperature control
unit in accordance with usage parameters associated with a user;
an information storage device to store said usage parameters, wherein
said information storage device is provided by said user to said
temperature control unit and said usage parameters stored on said
information storage device are adjusted by a service provider to
enable further use of said temperature control unit.
23. A temperature control system for thermally treating medical
items to desired temperatures comprising: a temperature control
unit including: a unit housing; a thermal treatment unit disposed
within said housing to thermally treat at least one medical item;
a controller to facilitate entry of a desired temperature and to
control a thermal output of said thermal treatment unit to thermally
treat said at least one medical item to said entered desired temperature;
and a usage control unit to control usage of said temperature control
unit in accordance with usage parameters associated with a user;
an information storage device to store said usage parameters, wherein
said information storage device is provided by said user to said
temperature control unit; wherein said usage control unit includes
a system interface to transfer information with said information
storage device, and wherein said system interface disables said
controller in response to said usage parameters indicating completion
of authorized use of said temperature control unit.
24. A temperature control system for thermally treating medical
items to desired temperatures comprising: a temperature control
unit including: a unit housing; a thermal treatment unit disposed
within said housing to thermally treat at least one medical item;
a controller to facilitate entry of a desired temperature and to
control a thermal output of said thermal treatment unit to thermally
treat said at least one medical item to said entered desired temperature;
and a usage control unit to control usage of said temperature control
unit in accordance with usage parameters associated with a user;
an information storage device to store said usage parameters, wherein
said information storage device is provided by said user to said
temperature control unit; wherein said usage control unit includes
a system interface to transfer information with said information
storage device, and wherein said system interface updates said usage
parameters in accordance with use of said temperature control unit
by said user.
25. The temperature control system of claim 24, wherein said temperature
control unit further includes: a display to display at least one
of said updated usage parameters to inform said user of remaining
authorized use of said temperature control unit.
26. A system for confining operational use of a temperature control
unit that thermally treats medical items to desired temperatures
to be within an authorized use interval in accordance with usage
parameters associated with a user and defining said authorized use
interval, wherein operation of said temperature control unit by
said user for thermally treating at least one medical item is disabled
outside said authorized use interval associated with said user,
said system comprising: a server computer system including a web
site accessible by said user to modify said authorized use interval
by adjusting said usage parameters to enable further use of said
temperature control unit by said user, and wherein said usage parameters
include at least one of a time interval for said operational usage
of said temperature control unit to thermally treat said at least
one medical item, a quantity of thermal cycles, a quantity of medical
items to thermally treat, and a duration a medical item remains
within said temperature control unit.
27. The system of claim 26 further including: an information storage
device to transfer information with said temperature control unit
and store collected information; an external interface to transfer
information with said information storage device; and an external
processing device coupled to said external interface to enable transfer
of information between said information storage device and said
server computer system.
28. The system of claim 27, wherein said information storage device
stores said usage parameters to control use of said temperature
control unit.
29. A system for controlling use of a temperature control unit
that thermally treats medical items to desired temperatures in accordance
with usage parameters associated with a user, said system comprising:
a server computer system to receive and store information collected
by said temperature control unit, wherein said server computer system
includes a web site accessible by said user to perform at least
one of retrieval of said collected information in the form of a
report and adjustment of said usage parameters to enable further
use of said temperature control unit, wherein said server computer
system communicates with said temperature control unit to receive
said collected information and adjust said usage parameters.
30. The system of claim 29, wherein said server computer system
communicates with said temperature control unit via a network.
31. The system of claim 29, wherein said temperature control unit
transfers said collected information to said server computer system
in real time to enable said user to access said transferred information
via an end user device to remotely monitor a status of said temperature
control unit.
32. A method of thermally treating medical items to desired temperatures
comprising: (a) receiving at least one medical item within a housing
of a temperature control unit for thermal treatment by a thermal
treatment unit; (b) facilitating entry of a desired temperature
and controlling a thermal output of said thermal treatment unit
to thermally treat said at least one medical item to said entered
desired temperature; and (c) confining operational usage of said
temperature control unit by a user for thermally treating said at
least one medical item to be within an authorized use interval for
said user defined by usage parameters associated with said user,
wherein operation of said temperature control unit by said user
for thermally treating said at least one medical item is disabled
outside said authorized use interval associated with said user and
said usage parameters include at least one of a time interval for
said operational usage of said temperature control unit to thermally
treat said at least one medical item, a quantity of thermal cycles,
a quantity of medical items to thermally treat, and a duration a
medical item remains within said system.
33. The method of claim 32, wherein step (a) further includes:
(a.1) heating said at least one medical item.
34. The method of claim 32, wherein step (a) further includes:
(a.1) cooling said at least one medical item.
35. The method of claim 32, wherein step (b) further includes:
(b.1) measuring a temperature of a corresponding medical item and
controlling said thermal output of said thermal treatment unit to
thermally treat said at least one medical item to said entered desired
temperature based on a corresponding measured temperature.
36. The method of claim 35, wherein step (b) further includes:
(b.2) measuring residence time of each medical item thermally treated
by said thermal treatment unit.
37. The method of claim 32, wherein step (c) further includes:
(c.1) storing said usage parameters on an information storage device,
wherein said information storage device is provided by said user
to said temperature control unit.
38. The method of claim 37, wherein said information storage device
includes at least one of a card, a memory device, a removable storage
device, an integrated circuit and a chip.
39. The method of claim 37, wherein step (b) further includes:
(b.1) collecting information pertaining to at least one of medical
item conditions, unit conditions, time, corresponding temperature
information for at least one medical item, patient information,
user information, doctor information and facility information.
40. The method of claim 39, wherein step (c) further includes:
(c.2) storing said collected information on said information storage
device.
41. The method of claim 40 further including: (d) providing said
information storage device to a service provider to retrieve said
stored information from said information storage device and generate
a report for said user.
42. The method of claim 40 further including: (d) performing, via
an external processing device, at least one of retrieval of information
from said information storage device in the form of a report and
adjustment of said usage parameters stored on said information storage
device to enable further use of said temperature control unit.
43. The method of claim 40, wherein an external device transfers
information with said information storage device and is coupled
to a server system with a web site, and said method further includes:
(d) transferring said collected information from said information
storage device to said server system; and (e) performing, via said
web site of said server system, at least one of retrieval of said
collected information from said server system in the form of a report
and adjustment of said usage parameters stored on said information
storage device to enable further use of said temperature control
unit.
44. The method of claim 32, wherein step (b) further includes:
(b.1) collecting information pertaining to at least one of medical
item conditions, unit conditions, time, corresponding temperature
information for at least one medical item, patient information,
user information, doctor information and facility information; and
(b.2) storing said collected information on a server system in communication
with said temperature control unit.
45. The method of claim 44, wherein said server system communicates
with said temperature control unit via a network.
46. The method of claim 44, wherein said server system includes
a web site accessible by said user via an end user device, and said
method further includes: (d) performing, via said web site of said
server system, at least one of retrieval of said collected information
in the form of a report and adjustment of said usage parameters
to enable further use of said temperature control system.
47. The method of claim 44, wherein step (b.1) further includes:
(b.1.1) transferring said collected information to said server system
in real time; and said method further includes: (d) accessing said
transferred information via an end user device to remotely monitor
a status of said temperature control unit.
48. The method of claim 47, wherein step (d) further includes:
(d.1) providing at least one alarm on said end user device to indicate
conditions exceeding prescribed requirements.
49. A method of thermally treating medical items to desired temperatures
comprising: (a) receiving at least one medical item within a housing
of a temperature control unit for thermal treatment by a thermal
treatment unit; (b) facilitating entry of a desired temperature
and controlling a thermal output of said thermal treatment unit
to thermally treat said at least one medical item to said entered
desired temperature; and (c) controlling usage of said temperature
control unit in accordance with usage parameters associated with
a user, wherein step (c) further includes: (c.1) storing said usage
parameters on an information storage device, wherein said information
storage device is provided by said user to said temperature control
unit; and (c.2) adjusting said usage parameters by a service provider
to enable further use of said temperature control unit.
50. A method of thermally treating medical items to desired temperatures
comprising: (a) receiving at least one medical item within a housing
of a temperature control unit for thermal treatment by a thermal
treatment unit; (b) facilitating entry of a desired temperature
and controlling a thermal output of said thermal treatment unit
to thermally treat said at least one medical item to said entered
desired temperature; and (c) controlling usage of said temperature
control unit in accordance with usage parameters associated with
a user, wherein step (c) further includes: (c.1) storing said usage
parameters on an information storage device, wherein said information
storage device is provided by said user to said temperature control
unit; and (c.2) transferring information with said information storage
device and disabling said temperature control unit in response to
said usage parameters indicating completion of authorized use of
said temperature control unit.
51. A method of thermally treating medical items to desired temperatures
comprising: (a) receiving at least one medical item within a housing
of a temperature control unit for thermal treatment by a thermal
treatment unit; (b) facilitating entry of a desired temperature
and controlling a thermal output of said thermal treatment unit
to thermally treat said at least one medical item to said entered
desired temperature; and (c) controlling usage of said temperature
control unit in accordance with usage parameters associated with
a user, wherein step (c) further includes: (c.1) storing said usage
parameters on an information storage device, wherein said information
storage device is provided by said user to said temperature control
unit; and (c.2) updating said usage parameters in accordance with
use of said temperature control unit by said user.
52. The method of claim 51, wherein step (c) further includes:
(c.3) displaying at least one of said updated usage parameters to
inform said user of remaining authorized use of said temperature
control unit.
53. A method of confining operational use of a temperature control
unit that thermally treats medical items to desired temperatures
to be within an authorized use interval in accordance with usage
parameters associated with a user and defining said authorized use
interval, wherein operation of said temperature control unit by
said user for thermally treating at least one medical item is disabled
outside said authorized use interval associated with said user,
said method comprising: (a) receiving and storing information collected
by said temperature control unit on a server computer system including
a web site accessible by said user; and (b) modifying said authorized
use interval by adjusting said usage parameters, via said web site,
to enable further use of said temperature control unit by said user,
wherein said usage parameters include at least one of a time interval
for said operational usage of said temperature control unit to thermally
treat said at least one medical item, a quantity of thermal cycles,
a quantity of medical items to thermally treat, and a duration a
medical item remains within said temperature control unit.
54. The method of claim 53, wherein step (a) further includes:
(a.1) storing said collected information on an information storage
device; (a.2) transferring information between said information
storage device and said temperature control unit; and (a.3) transferring
information between said information storage device and said server
computer system.
55. The method of claim 54, wherein step (a.1) further includes:
(a.1.1) storing said usage parameters on said information storage
device to control use of said temperature control unit.
56. A method of controlling use of a temperature control unit that
thermally treats medical items to desired temperatures in accordance
with usage parameters associated with a user, said method comprising:
(a) receiving and storing information collected by said temperature
control unit on a server computer system including a web site accessible
by said user, wherein said server computer system conununicates
with said temperature control unit, and step (a) further includes:
(a.1) receiving said collected information from said temperature
control unit and adjusting said usage parameters via said server
computer system; (b) performing, via said web site, at least one
of retrieval of said collected information in the form of a report
and adjustment of said usage parameters to enable further use of
said temperature control unit.
57. The method of claim 56, wherein said server computer system
communicates with said temperature control unit via a network.
58. The method of claim 56, wherein step (a.1) further includes:
(a.1.1) transferring said collected information from said temperature
control unit to said server computer system in real time; and said
method further includes: (c) accessing said transferred information
via an end user device to remotely monitor a status of said temperature
control unit.
59. A system for controlling usage of a medical device comprising:
a medical device; and a usage control unit to confine operational
usage of said medical device by a user to be within an authorized
use interval for said user defined by usage parameters associated
with said user, wherein said usage control unit disables operation
of said medical device by said user outside said authorized use
interval associated with said user and said usage parameters include
at least one of a time interval for said operational usage of said
medical device and a quantity of operational cycles.
60. The system of claim 59, wherein said medical device collects
information pertaining to at least one of system conditions, time,
patient information, user information, doctor information and facility
information.
61. The system of claim 60 further including: an information storage
device to store at least one of said usage parameters and said collected
information, wherein said information storage device is provided
by said user to said medical device.
62. The system of claim 61, wherein said information storage device
includes at least one of a card, a memory device, a removable storage
device, an integrated circuit and a chip.
63. The system of claim 61, wherein said information storage device
is provided to a service provider to retrieve said stored information
from said information storage device and generate a report for said
user.
64. The system of claim 60 further including: a server computer
system to receive and store said collected information, wherein
said server computer system includes a web site accessible by said
user to perform at least one of retrieval of said collected information
in the form of a report and adjustment of said usage parameters
to enable further use of said medical device.
65. A method of controlling use of a medical device comprising:
(a) confining operational usage of said medical device by a user
to be within an authorized use interval for said user defined by
usage parameters associated with said user, wherein operation of
said medical device by said user is disabled outside said authorized
use interval associated with said user and said usage parameters
include at least one of a time interval for said operational usage
of said medical device and a quantity of operational cycles.
66. The method of claim 65, wherein step (a) further includes:
(a.1) collecting information, via said medical device, pertaining
to at least one of system conditions, time, patient information,
user information, doctor information and facility information.
67. The method of claim 66, wherein step (a) further includes:
(a.2) storing at least one of said usage parameters and said collected
information on an information storage device, wherein said information
storage device is provided by said user to said medical device.
68. The method of claim 67, wherein said information storage device
includes at least one of a card, a memory device, a removable storage
device, an integrated circuit and a chip.
69. The method of claim 67, wherein step (a) further includes:
(a.3) providing said information storage device to a service provider
to retrieve said stored information from said information storage
device and generate a report for said user.
70. The method of claim 66, wherein step (a) further includes:
(a.2) receiving and storing said collected information on a server
computer system, wherein said server computer system includes a
web site accessible by said user; and (a.3) performing, via said
web site, at least one of retrieval of said collected information
in the form of a report and adjustment of said usage parameters
to enable further use of said medical device.
71. The method of claim 65, wherein step (a) further includes:
(a.1) leasing said medical device to said user, wherein said usage
parameters include values to control use of said medical device
in accordance with an associated leasing arrangement.
72. The method of claim 65, wherein step (a) further includes:
(a.1) renting said medical device to said user, wherein said usage
parameters include values to control use of said medical device
in accordance with an associated rental arrangement.
Medical Patent Description
BACKGROUND OF THE INVENTION
1. Technical Field
The present invention pertains to medical item thermal treatment
and/or monitoring systems, such as the types disclosed in U.S. Pat.
No. 5,408,576 (Bishop); U.S. Pat. No. 6,259,067 (Faries, Jr. et
al.); U.S. Pat. No. 6,294,762 (Faries, Jr. et al.); U.S. Pat. No.
6,371,121 (Faries, Jr. et al.); U.S. Pat. No. 6,384,380 (Faries,
Jr., et al.); U.S. Pat. No. 6,376,805 (Faries, Jr. et al.); U.S.
Pat. No. 6,467,953 (Faries, Jr. et al.); U.S. Pat. No. 6,566,631
(Faries, Jr. et al.) and U.S. Pat. No. 6,660,974 (Faries, Jr. et
al.); U.S. Patent Application Publication Nos.: 2002/0147426 (Faries,
Jr. et al.) and 2003/0114795 (Faries, Jr. et al.); and U.S. patent
application Ser. No. 09/380,507, entitled "Method and Apparatus
for Pressure Infusion and Temperature Control of Infused Liquids"
and filed Apr. 24, 2000. The disclosures of the foregoing patents,
patent publications and patent applications are incorporated herein
by reference in their entireties. In particular, the present invention
is directed toward monitoring intravenous solution or other medical
items for compliance with prescribed requirements (e.g., manufacturer,
medical standards or regulations, etc.) from the time the solution
is prepared through disposal of the solution after use in a medical
procedure. In other words, the medical solution or other medical
items are monitored from manufacture at a manufacturing plant, through
transport and/or storage to an end user or medical facility, through
subsequent thermal treatment by that user and during administration
to a patient. In this manner, a complete record of temperature and/or
other conditions for the medical item is ascertained to determine
and/or indicate to medical personnel compliance with the prescribed
requirements.
2. Discussion of Related Art
Various types of medical items require heating to a selected temperature
prior to utilization in a medical procedure. Generally, the medical
items may be heated for limited time intervals to preserve their
effectiveness. These items typically include intravenous solutions,
irrigation fluids, surgical instruments, bottles and blankets. Intravenous
(IV) fluids, for example, are typically stored in a cool environment
and, consequently, require heating to precise temperatures to prevent
thermal shock and injury from occurring during infusion of the fluid
into a patient. Similarly, irrigation fluids can be warmed or cooled
to various temperatures depending upon their intended use. These
types of fluids are typically provided to a patient utilizing a
flexible bag or container filled with the fluid and delivered via
a fluid line that conveys the fluid from the bag to the patient.
Some medical items can only be heated for a limited period of time,
or in accordance with controlled warming cycles, in order to avoid
adversely affecting their effectiveness. For example, some fluids,
such as whole blood or fluids containing medication, should be warmed
evenly to a specific temperature and can be rendered unusable or
unsafe if all or a portion of the fluid is overheated.
In order to provide the necessary heated items for use in medical
procedures, the related art provides devices for regulating and/or
monitoring temperature of medical items. For example, ovens may
be disposed within operating rooms to heat items to desired temperatures.
Further, U.S. Pat. No. 4,419,568 (Van Overloop) discloses a wet
dressings heater having a base with side walls defining a cavity,
and an insert connected to the base and defining at least one recess
in the cavity for receiving wet dressings. A heater has an electrical
heating element in close proximity to the insert recess for heating
the wet dressings, while the temperature of the heating element
is controlled in a desired temperature range for those wet dressings.
U.S. Pat. No. 4,495,402 (Burdick et al.) discloses a warmer for
heating wet dressings and other articles disposed within a heating
and storage compartment. The articles are arranged within the compartment
in stacked relation and disposed on a plate that is supplied with
thermal energy from a heater. The plate includes a center aperture
whereby a first thermal sensor is disposed in the aperture in contact
with a bottom most article. Control circuitry is disposed beneath
the plate to control the heater to maintain temperature of the bottom
most article at a desired level based on the temperatures sensed
by the first thermal sensor and a second thermal sensor responsive
to heater temperature.
U.S. Pat. No. 4,859,360 (Suzuki et al.) discloses a blood bag having
a temperature-monitoring device in the form of a tag or label adhered
to the bag outer surface. The temperature-monitoring device includes
plural reversible temperature indicators each associated with a
specific temperature range to indicate a current temperature of
the blood, and an irreversible temperature indicator to indicate
that the blood has currently or previously reached a predetermined
temperature. The reversible indicators individually provide visual
indications in response to the current blood temperature being within
a corresponding range, while the irreversible indicator maintains
a visual indication once the predetermined temperature has been
reached.
U.S. Pat. No. 5,408,576 (Bishop) discloses an intravenous fluid
warmer having a cabinet structure to accommodate a plurality of
intravenous fluid bags. A temperature sensor and pad of heating
filaments are disposed within the cabinet structure, whereby the
temperature sensor enables automatic temperature regulation of the
pad of heating filaments to heat the intravenous fluid bags. The
heating filaments are covered by a rubber layer to prevent melting
of the bags during heating. A temperature indicator disposed on
the cabinet structure permits a user to ascertain when a desired
temperature is attained, whereby an intravenous fluid bag is removed
from the intravenous fluid warmer via an opening defined in a side
of the cabinet structure.
U.S. Pat. No. 5,986,239 (Corrigan, III et al.) discloses a conductive
warmer for flexible plastic bags. The warmer includes a heat-conducting
member of thermally conductive material having a plurality of fins
which are parallel and spaced apart to define a plurality of bag-receiving
compartments. The fins are connected to a back portion of the heat-conducting
member to which a heating element is attached in a heat-exchanging
relationship. The heating element conducts heat through the back
portion and fins of the heat-conducting member to the bags.
The devices described above suffer from several disadvantages.
In particular, temperature and heating requirements are typically
prescribed for medical solutions or other medical items from various
sources (e.g., manufacturer, medical standard or regulation, etc.).
These requirements typically prescribe a particular temperature
range, expiration date or time and certain time intervals for heating
the medical solution in order to maintain the solution efficacy.
The above-described devices generally do not monitor medical items
for or indicate compliance with these prescribed requirements throughout
the life of the medical item (e.g., from manufacture through use
and disposal). For example, the above-described warming devices
may provide a temperature indication during heating, but do not
monitor the heating time intervals for the medical items, the medical
item temperatures during storage or usage outside of the device
or the medical item expiration date. Although the Suzuki et al.
device is secured to and monitors temperature of a blood bag, there
is no manner for that device to monitor or indicate the heating
intervals and/or passage of the expiration date or time for the
blood bag. Thus, medical personnel may unknowingly administer to
patients solutions and/or medication that are unusable and/or have
reduced potency due to non-compliance with prescribed requirements
(e.g., an exceeded expiration date, prolonged exposure to heat,
attainment of temperatures outside the prescribed range, etc.),
thereby risking serious injury to patients.
OBJECTS AND SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to monitor
medical item conditions and indicate compliance with prescribed
requirements from the time the item is prepared through item disposal
after use (e.g., throughout the life of the medical item) to prevent
use of compromised medical items with patients.
It is another object of the present invention to thermally treat
medical items and monitor medical item conditions (e.g., heating
time, temperature, etc.) for, and/or indicate compliance with, prescribed
requirements.
Yet another object of the present invention is to control usage
of thermal treatment systems.
Still another object of the present invention is to monitor medical
item conditions during thermal treatment and generate hardcopy or
electronic reports indicating those conditions.
A further object of the present invention is to mark or otherwise
transcribe information associated with a medical item on that medical
item to notify medical personnel of the medical item status with
respect to prescribed requirements.
The aforesaid objects may be achieved individually and/or in combination,
and it is not intended that the present invention be construed as
requiring two or more of the objects to be combined unless expressly
required by the claims attached hereto.
According to the present invention, various devices enable medical
personnel or users to adhere to medical regulatory and medical item
manufacturer requirements relating to medical item heating time,
temperature and/or other conditions in order to ensure patient safety.
For example, intravenous (IV) fluid bags are typically heated to
precise temperatures to prevent thermal shock and injury from occurring
during infusion of the IV fluid into a patient. Generally, the fluid
bags may be heated for limited time intervals to preserve their
effectiveness. These time limits may be prescribed by medical standards
or regulations, or by the manufacturer of the fluid. A medical solution
container or other medical item of the present invention includes
a monitoring or data recording device to monitor and/or record medical
solution conditions. The device may further include indicators to
indicate compliance of the medical solution with prescribed requirements
(e.g., manufacturer, medical standard or regulation, etc.), typically
pertaining to medical solution temperature and heating time intervals
sufficient to maintain efficacy of the medical solution. The monitoring
device may be embedded within or disposed on a container wall or,
alternatively, be disposed within the solution, and may utilize
a wireless communication link to transfer recorded information.
The medical solution container may alternatively include an electronic
memory device attached to or contained within the medical solution
container. The memory device is capable of recording information
received from an external device, such as a thermal treatment system
that has been configured to store warming cycle time, temperature
and/or other information in the respective container embedded devices.
The container may further include electronically activated visible
indicators that are triggered based upon compliance with prescribed
requirements.
The medical solution container may alternatively include an external
barcode or transponder, where the solution container is identified
with a unique bar code and/or transponder signal or code that identifies
the container to a thermal treatment system measuring medical solution
conditions. The thermal treatment system may transmit event data
and/or other information pertaining to the container to a central
database.
In another embodiment, the medical solution container may include
electrochromic ink cells and a control circuit. The control circuit
monitors external and/or internal conditions of the container environment
and triggers individual electrochromic cells in response to the
presence of one or more conditions (e.g. max temperature limit exceeded,
max humidity exceeded, etc.) to indicate compliance with prescribed
requirements. Alternatively, monitoring may be performed by an external
unit, such as a thermal treatment system or a box used to transport
medical solutions or other sensitive components. In this case, the
container includes the electrochromic cells (and, preferably, text
identifying the meaning of each) and a conducting lead to connect
the container and corresponding electrochromic cells to the external
monitoring unit. The unit monitors the container environment and
activates selected electrochromic cells upon the container to cause
the electrochromic cell to change color (e.g., from clear to opaque,
etc.) upon determining that allowable conditions have been exceeded.
In addition, the electrochromic cell on the container may be manually
activated by pressing a current source button upon the container
to cause the electrochromic cell to change color, thereby allowing
a manual over-ride to indicate medical item status with respect
to the prescribed requirements.
The present invention further includes various thermal treatment
systems that monitor medical solution containers or other medical
items for prescribed requirements (e.g., temperature, heating time
intervals, etc.) and display the monitored parameters to medical
personnel. These systems may be utilized with conventional medical
solution containers or the containers described above to monitor
solution conditions. The thermal treatment systems may be monitored
and controlled via an information device containing operational
parameters. Moreover, the systems may monitor the time, temperature
and/or other conditions of thermally treated items to generate reports
(e.g., printed reports, displays, reports in electronic form, etc.)
for users.
In addition, the present invention may place time stamp information
on medical solution containers (e.g., bags or bottles containing
saline or intravenous (IV) solutions, antibiotics or other drugs,
blood, etc.) or other medical items (e.g., instruments, blankets,
etc.) to enable determination by medical personnel of compliance
with prescribed requirements (e.g., residence time within a thermal
treatment system, the remaining effective or utilization life of
the medical solution or other item, etc.).
The above and still further objects, features and advantages of
the present invention will become apparent upon consideration of
the following detailed description of specific embodiments thereof,
particularly when taken in conjunction with the accompanying drawings,
wherein like reference numerals in the various figures are utilized
to designate like components.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a view in perspective of a medical solution container
including a monitoring device to monitor solution conditions according
to the present invention.
FIG. 2 is a schematic block diagram of the monitoring device of
FIG. 1.
FIG. 3 is a view in perspective of a medical solution container
including a memory device to record and/or indicate solution conditions
according to the present invention.
FIG. 4 is a schematic block diagram of the memory device of FIG.
3.
FIG. 5 is a view in perspective of a medical solution container
including a bar code serving to identify the medical solution container
according to the present invention.
FIG. 6 is a view in perspective of a medical solution container
including a transponder unit according to the present invention.
FIG. 7 is schematic block diagram of the transponder unit of FIG.
6.
FIG. 8 is a view in perspective of a medical solution container
including electrochromatic cells to indicate solution conditions
according to the present invention.
FIG. 9 is a schematic block diagram of a control circuit for the
electrochromatic cells of FIG. 8.
FIG. 10 is a system level block diagram of an exemplary thermal
treatment system that monitors thermally treated items and may generate
reports and/or control system usage according to the present invention.
FIG. 11 is a block diagram of the report unit within the system
of FIG. 10 to generate and/or print reports according to the present
invention.
FIGS. 12A-12I are schematic illustrations of exemplary reports
produced by the system of FIG. 10 in accordance with the present
invention.
FIG. 13 is a block diagram of the usage control unit within the
system of FIG. 10 to control system usage according to the present
invention.
FIG. 14 is a diagrammatic illustration of an alternative embodiment
of the usage control unit of FIG. 13 with a computer system to access
monitored thermal treatment system information according to the
present invention.
FIG. 15 is a diagrammatic illustration of yet another embodiment
of the usage control unit of FIG. 13 in communication with storage
and monitoring devices via a network according to the present invention.
FIG. 16 is a procedural flow chart illustrating the manner in which
a medical item thermal treatment system thermally treats a medical
item and monitors and controls system use according to the present
invention.
FIG. 17 is a procedural flow chart illustrating the manner in which
the present invention enables a user to monitor and control thermal
treatment system use.
FIG. 18 is a view in perspective of an exemplary modular warmer
unit according to the present invention.
FIG. 19 is a top view in plan of a tray or drawer for the unit
of FIG. 18 including individual monitoring assemblies and a configuration
to enable storage of numerous medical solution containers in a generally
upright position.
FIG. 20 is a view in perspective of an exemplary type of thermal
treatment system for thermally treating and monitoring a medical
solution within a basin according to the present invention.
FIG. 21 is a view in perspective of an exemplary type of thermal
treatment system for thermally treating and monitoring solution
within an IV line according to the present invention.
FIG. 22 is a view in perspective of a temperature control system
for heating medical items and measuring and displaying residence
time of those items within the system in accordance with the present
invention.
FIG. 23 is a front view in elevation of the system of FIG. 22.
FIG. 24 is an exploded perspective view of a drawer of the system
of FIG. 22.
FIG. 25 is a view in elevation of an exemplary heating element
of the system of FIG. 22.
FIG. 26 is an electrical schematic diagram of an exemplary control
circuit of the system of FIG. 22.
FIG. 27A is a view in perspective of a temperature control system
including guides and a timer according to the present invention.
FIG. 27B is a top view in plan of a limit switch arm employed by
the system of FIG. 27A.
FIG. 27C is a side view in partial section of the system of FIG.
27A.
FIGS. 28A-28D are views in perspective of exemplary guides of the
system of FIG. 27A.
FIG. 29 is an electrical schematic diagram of an exemplary control
circuit for the system of FIG. 27A.
FIG. 30 is a view in perspective of a temperature control system
for heating plural medical items and measuring and displaying residence
time of those items within the system according to the present invention.
FIGS. 31A-31B are schematic illustrations of exemplary display
screens for the system of FIG. 30 with temperature indications in
Celsius and Fahrenheit, respectively.
FIG. 32 is an electrical schematic diagram of an exemplary control
circuit for the system of FIG. 30.
FIG. 33 is an electrical schematic diagram of a heat control circuit
of the control circuit of FIG. 32.
FIG. 34 is a system flow diagram of an exemplary system for placing
time stamp information on medical items and thermally treating those
items according to the present invention.
FIG. 35A is a view in elevation of an exemplary medical item in
the form of an intravenous solution bag including time stamp information
placed on the bag exterior surface according to the present invention.
FIG. 35B is a view in elevation of an exemplary medical item in
the form of an intravenous solution bag disposed within a liner
or overwrap, whereby time stamp information is placed on the liner
according to the present invention.
FIG. 36 is a schematic block diagram of a marking device of the
system of FIG. 34.
FIGS. 37A-37B are schematic illustrations of exemplary labels with
time stamp information for placement on a medical item according
to the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present invention enables monitoring of a medical item (e.g.,
medical solution containers or bags, etc.) for compliance with prescribed
requirements (e.g., manufacturer, medical standard or regulation,
etc.) to ensure the medical item maintains efficacy and remains
pharmaceutically acceptable. The present invention enables monitoring
(e.g., continuously and/or at any intervals, etc.) of the medical
item at each or any of the stages (e.g., manufacture, transport,
storage, thermal treatment, use with patients, etc.) from the time
the solution is prepared through disposal of the solution after
use in a medical procedure. In other words, a medical solution or
other medical items are monitored (e.g., temperature, heating time,
age or utilization life, etc.) from manufacture at a manufacturing
plant, through transport and/or storage to an end user or medical
facility, through subsequent thermal treatment by the end user and/or
during administration of the solution to a patient. In this manner,
a complete record of temperature and/or other conditions for the
medical item is ascertained to determine and/or indicate to medical
personnel compliance with the prescribed requirements. Thus, the
present invention basically enables users to conform to regulatory
and medical item manufacturer requirements, typically relating to
medical item heating time, utilization life and temperature, in
order to ensure patient safety.
A medical item including a monitoring device according to the present
invention is illustrated in FIG. 1. Initially, a medical item 2
is preferably an intravenous solution bag; however, the medical
item may be implemented by a wide variety of medical items (e.g.,
medical solution containers, saline solutions, IV solutions and/or
lines, instruments, blankets, antibiotics or other drugs, blood,
irrigation fluid and/or lines, etc.). Specifically, intravenous
solution bag 2 is in the form of a conventional intravenous solution
bag and is constructed of plastic or other materials commonly utilized
for forming those types of bags. The solution bag may contain various
types of solutions, such as saline solution, blood, antibiotic or
other drugs, or any other intravenously administered solution. Intravenous
solution bag 2 further includes a generally triangular projection
4 attached to and extending from the bag upper portion. Projection
4 preferably includes a truncated upper portion having an opening
or hole 6 defined therein for interfacing an intravenous pole or
other support structure (not shown). The bag lower portion includes
an outlet 7 and associated fluid conduits 15 to interface an intravenous
tube (not shown) and enable the solution to flow through the tube
from the outlet to a patient.
Generally, intravenous solutions are required to be within a specific
temperature range prior to and/or during infusion to avoid injury
to a patient as described above. For example, fluids intravenously
administered to a patient have a temperature near the patient body
temperature, preferably in the approximate range of 86.degree. F.-104.degree.
F., and should not exceed a maximum temperature to maintain solution
efficacy. Further, the solutions typically have a prescribed utilization
life or expiration date and heating time in order to maintain their
efficacy as described above. The present invention monitors conditions
of the solution bag in order to ensure compliance with the prescribed
requirements (e.g., from the medical item manufacturers, medical
standard or regulation, etc.). In particular, solution bag 2 further
includes a monitoring or data recording device 10. The monitoring
device includes or is coupled to sensors 16 (FIG. 2) to monitor
the solution bag from the time the bag is filled with fluid to the
process of dispensing the fluid to the patient. The monitoring device
measures and stores information (e.g., age of solution, time, temperature,
humidity, heating interval, maximum temperature attained, manufacturing
date, expiration date or time, amount or volume of solution, strength
of solution, diluent, directions, etc.). The measured information
may be measured either on a periodic basis or in response to an
incremental positive or negative change in a monitored parameter
(e.g., a change in temperature, humidity, etc.).
Monitoring device 10 is typically attached to the interior or exterior
bag surface in a manner enabling the sensors to measure solution
conditions. The monitoring device may be attached to or embedded
within the bag surface at any desired locations via any conventional
or other techniques (e.g., adhesive, welding, lamination, etc.).
For example, the monitoring device may be attached to the bag during
bag construction, where a pouch or receptacle (not shown) may be
adhered or sealed to the bag interior or exterior surface to receive
the monitoring device. Alternatively, the monitoring device may
be disposed within the bag interior in a suspended or floating state
within the solution. In this case, the monitoring device may include
any conventional or other suitable floatation devices to suspend
the device within the solution.
The monitoring device may further include a display 12 and/or indicators
14 to indicate measured parameters to medical personnel. The display
may be of any shape, size or type (e.g., LED, LCD, etc.), may be
disposed at any location on the monitoring device or bag and may
display any information. Indicators 14 are preferably implemented
by light emitting diodes (LED) and may indicate to medical personnel
conditions and/or compliance with prescribed requirements. The indicators
may be disposed at any locations on the monitoring device or bag
and may be activated based upon a local assessment of the recorded
information or based upon an external assessment of the recorded
information by an external processor. In addition, the activation
of the indicators may be based upon local or external assessment
of the recorded information with respect to stored predetermined
parameters relating to the prescribed requirements. The monitoring
device further includes an interface 20 (FIG. 2) to facilitate communications
with an external device 21 as described below and transfer recorded
information. The external device may be coupled to an external database
for storage and retrieval of information.
Referring to FIG. 2, monitoring device 10 includes one or more
sensors 16, a processor 18 and an interface 20. A power source (not
shown), preferably in the form of batteries, provides power to the
components. The monitoring device may further include display 12
and/or indicators 14 as described above. Processor 18 is typically
implemented by a conventional microprocessor and controls operation
of the monitoring device. However, the processor may alternatively
be implemented by any hardware or circuitry. The processor is coupled
to display 12, indicators 14, sensors 16 and interface 20. Sensors
16 are preferably implemented by various conventional or other sensors
(e.g., proximity sensors, pressure sensors, temperature sensors
(e.g., RTD, infrared, etc.), presence sensors, weight sensors, volume
sensors, flow sensors, fluid sensors, fluid level sensors, etc.)
to measure corresponding conditions (e.g., solution temperature,
humidity, fluid level, etc.). The sensors may be disposed in a common
monitoring device housing or be external of the monitoring device
within the solution bag to measure the corresponding conditions.
The measured parameters are provided to processor 18, where the
processor may record the measured conditions and time of measurement
for storage and/or display. The stored values may be downloaded
to an external device 21 as described below. The monitoring device
may further record item locations (e.g., manufacturing plant, storage
locations, transport, medical facility, etc.) and/or other information
to correspond with the time, temperature and/or other recordings
as described below.
The monitoring device is typically activated at the fluid bag manufacturing
plant. As the bag is being produced, solution temperatures and/or
other conditions are recorded in the processor (or an external)
memory. In addition, the monitoring device may store solution information
from the manufacturer or other source (e.g., name, strength, amount
or volume, expiration date or time, date prepared and diluent, location,
directions, etc.). The monitoring device records the temperature
of the solution and/or other conditions as the bag moves from the
manufacturer, through shipping and storage to the end user or medical
facility. The monitoring device further records solution temperature
and/or other conditions in the event of thermal treatment of the
bag by the end user and during administration of solution to the
patient. This provides medical personnel or the medical facility
with a complete record of temperature and/or other conditions for
each solution bag to enable determination of compliance with prescribed
requirements (e.g., age, temperature, re-warming, heating intervals,
etc.) based on the information in the record.
The processor may further include information associated with the
prescribed requirements (e.g., age, temperature, heating intervals,
no re-warming, etc.) and determine compliance with those requirements
based on the measured values. This enables the requirements to be
programmable, where the monitoring device may be used for any medical
solutions and/or prescribed requirements. The measured values and/or
a compliance indication may be indicated to medical personnel via
display 12 and/or indicators 14. For example, the processor may
control the display to indicate the measured values, prescribed
requirements and/or an indication (e.g., message, symbol, etc.)
of non-compliance with those requirements. The indicators may be
of different colors to indicate compliance (e.g., a green LED),
marginal compliance (e.g., a yellow LED) or non-compliance (e.g.,
a red LED) with any of those requirements (e.g., the indicators
may be associated with any quantity of the requirements (e.g., expiration
date, temperature, heating interval, re-warming, etc.) to indicate
non-compliance with those requirements). Thus, the monitoring device
continuously monitors medical items for compliance with prescribed
requirements at each stage of the solution life and immediately
indicates non-compliance or a compromised solution to medical personnel.
Interface 20 is coupled to processor 18 and facilitates communications
with an external device 21 for transfer of information. The interface
is typically in the form of a conventional wireless transceiver
(e.g., RF, infrared, etc.) to communicate with the external device.
The external device may be in the form of a corresponding wireless
transmitter/receiver (e.g., RF, infrared, etc.) of a processing
device or system (e.g., computer station or system, hand-held device,
etc.). The recorded information in the processor may be downloaded
at any time by the use of the wireless transmitter/receiver. A user
positions the solution bag in close proximity to the wireless transmitter/receiver,
where the external device instructs the monitoring device to transmit
the recorded information from memory. Alternatively, the interface
may be in the form of a connector or port for connection to a corresponding
port of the external device (e.g., connection to the processing
device or system) via a cable. The interface receives an instruction
from the external device and forwards the request to the processor
to retrieve the desired information. The processor further controls
interface 20 to provide the information to the requesting device.
The information transmitted to the external device includes raw
data that is processed by the external wireless transmitter/receiver
or processing system to produce a user friendly format (e.g., a
data sheet, a line graph that charts the temperatures over time
and location, etc.). The resulting information may be presented
on a screen for the user to view, printed for documentation purposes
or stored in local or remote database accessible by users or medical
personnel.
Location information (e.g., codes for a manufacturer loading dock,
hospital receiving or Operating Room, etc.) may be entered into
the external device by the user (e.g., by keying into the wireless
transmitter/receiver or processing device the location code) for
subsequent transmission to the monitoring device for storage. This
enables monitored parameters to be associated with the location
of the bag. Alternatively, the monitoring device may further include
a conventional Global Positioning System (GPS) transceiver 22 to
communicate with a GPS satellite to obtain location and/or time
information. The transceiver may be implemented by any conventional
or other GPS transceiver and is coupled to and controlled by processor
18 to retrieve the information for storage.
The external device may further enable entry or provide various
information (e.g., start date and start time of solution or other
item heating/cooling, the time interval the solution or other item
was heated/cooled, the temperature the solution or other item attained
during heating/cooling and/or the time and temperature of the solution
or other item when the solution was removed from the system (e.g.,
partial or complete history of time and solution or other item temperature,
facility information (e.g., including name, location, etc.), patient
information (e.g., including patient identification number, patient
age, patient name, patient sex, patient medications, patient diagnoses,
patient commodities and conditions, patient lab values, patient
allergies and sensitivities, patient weight and height, patient
pregnancy and lactation status, dosage information, etc.), doctor
information, type of procedure, the solution information described
above, type of instruments or other item being heated/cooled, amount
or quantity of solution or other item being heated/cooled, etc.)
for transmission to and storage in the monitoring device. The external
devices may be disposed at various locations (e.g., manufacturing
plant, transport station, medical facility, etc.) to enable entry
and/or retrieval of information. Alternatively, the information
may be entered into the monitoring device or retrieved for display
on display 12 via processor input devices (e.g., keypad, etc.).
The monitoring device may further determine and/or indicate various
conditions relating to the entered information. For example, a monitoring
device equipped with fluid sensors may determine and/or indicate,
via display 12 and/or indicators 14, when an appropriate dosage
has been administered to a patient. Moreover, the monitoring device
may include a unique identifier, where external device 21 may retrieve
and store information from the monitoring device in a local or remote
central database based on the identifier for subsequent access by
users or medical personnel. This enables information for the particular
bag to be retrieved and examined and/or be utilized for tracking,
inventory and/or availability purposes. By way of example, solution
bags 2 may communicate with external devices disposed at various
locations (e.g., manufacturing plant, transport, storage, medical
facility, etc.) to enable the bags to be located or tracked (e.g.,
via location codes or the GPS). The information may further be stored
in a database and accessed to determine inventory and/or solution
availability for the particular location. In addition, the monitoring
device and/or centrally stored information may immediately notify
medical personnel of compromised solutions (e.g., expired, damaged,
contaminated, unsafe, etc.), thereby enabling easy identification
and segregation of those compromised items until proper disposal.
The processor and/or interface may utilize any conventional or other
suitable protocol to communicate with and transfer information with
the external device.
In operation, the solution bag is constructed with fluid and appropriate
information is stored in the monitoring device. The bag is transported
to an intended facility, where the monitoring device continuously
monitors the solution. Prior to use, medical personnel may view
the monitoring device (and/or access the central database) to determine
compliance with prescribed requirements. The monitoring device continues
to monitor the solution and indicate compliance during thermal treatment
and/or administration of solution to a patient. The monitoring device
may be disposable with the bag or re-programmed for use with subsequent
bags.
The monitoring device may further be configured to communicate
with a thermal treatment system as described below to transfer the
recorded information. In this case, the thermal treatment system
includes the wireless transmitter/receiver or connection port to
continuously communicate with interface 20 of the monitoring device
as described above. The recorded information may be utilized by
the thermal treatment system to control heating of the solution
bag to a desired set point temperature.
A medical item including a memory device to store information pertaining
to conditions measured by a thermal treatment system according to
the present invention is illustrated in FIG. 3. Initially, medical
item 2 is substantially similar to the medical item described above
and is preferably an intravenous solution bag, but may be a wide
variety of medical items (e.g., medical solution containers, saline
solutions, IV solutions and/or lines, instruments, blankets, antibiotics
or other drugs, blood, irrigation fluid and/or lines, etc.). Specifically,
intravenous solution bag 2 includes a generally triangular projection
4 attached to and extending from the bag upper portion and including
opening or hole 6 defined therein as described above for interfacing
an intravenous pole or other support structure (not shown). The
bag lower portion includes an outlet 7 and associated fluid conduits
15 to interface an intravenous tube (not shown) and enable the solution
to flow through the tube from the outlet to a patient as described
above.
The present invention records conditions of the solution bag measured
by a thermal treatment system in order to ensure compliance with
the prescribed requirements. In particular, solution bag 2 further
includes a memory device 24. The memory device records information
received from an external device 21, such as a thermal treatment
system treating the solution bag. The thermal treatment system is
configured to measure and transmit warming cycle, time-temperature
and other information (e.g., start date and start time of solution
or other item heating/cooling, the time interval the solution or
other item was heated/cooled, the temperature the solution or other
item attained during heating/cooling and/or the time and temperature
of the solution or other item when the solution was removed from
the system (e.g., partial or complete history of time and solution
or other item temperature), the facility, patient and/or solution
information described above, doctor information, type of procedure,
type of instruments or other item being heated/cooled, amount or
quantity of solution or other item being heated/cooled, etc.) to
the memory device as described below.
Memory device 24 is typically attached to or embedded within the
bag surface and may be disposed at any desired locations via any
conventional or other techniques (e.g., adhesive, welding, lamination,
etc.). For example, the monitoring device may be attached to the
bag during bag construction, where a pouch or receptacle (not shown)
may be adhered or sealed to the bag interior or exterior surface
to receive the memory device. Alternatively, the memory device may
be disposed within the bag interior in a suspended or floating state
within the solution. In this case, the memory device may include
any conventional or other suitable floatation devices to suspend
the device within the solution.
The memory device may further include a display 12 and/or indicators
14 to indicate measured parameters to medical personnel. The display
may be of any shape, size or type (e.g., LED, LCD, etc.), may be
disposed at any location on the memory device or bag, and may display
any information. Indicators 14 are preferably implemented by light
emitting diodes (LED) and may indicate to medical personnel conditions
and/or compliance with prescribed requirements as described above.
The indicators may be disposed at any locations on the memory device
or bag and may be activated based upon a local assessment of the
recorded information or based upon an external assessment of the
recorded information by an external processor as described above.
For example, the memory device may activate a visible indicator
each time a warming cycle is initiated by a thermal treatment system
or trigger a visible indicator in response to exceeding a pre-determined
maximum number of warming cycles or heating interval, the solution
temperature being beyond an acceptable temperature range, re-warming
of the bag, etc. The activation of the indicators may be based upon
various criteria (e.g., stored logical data and concurrently measured
physical data, etc.). In addition, the activation of the indicators
may be based upon the local or external assessment of the recorded
information with respect to stored predetermined parameters relating
to the prescribed requirements. The memory device further includes
an interface 20 (FIG. 4) to facilitate communications with a thermal
treatment system as described below and receive information.
Referring to FIG. 4, memory device 24 includes processor 18 and
interface 20. A power source (not shown), preferably in the form
of batteries, provides power to the components. The memory device
may further include display 12 and/or indicators 14 as described
above. Processor 18 is substantially similar to the processor described
above and controls operation of the memory device. The processor
is coupled to display 12, indicators 14 and interface 20. Interface
20 facilitates communications with an external device 21 to transfer
information. The external device is typically in the form of a thermal
treatment system as described below that treats the solution bag.
The thermal treatment system may include various sensors (e.g.,
proximity sensors, pressure sensors, temperature sensors (e.g.,
RTD, infrared, etc.), presence sensors, weight sensors, volume sensors,
flow sensors, fluid sensors, fluid level sensors, etc.) to measure
conditions of the solution (e.g., temperature, heating intervals,
time, humidity, etc.) for transfer to the memory device. The interface
may be in the form of a conventional wireless transceiver as described
above to communicate with a wireless transmitter/receiver of the
thermal treatment system or, alternatively, may be in the form of
a conventional connector to physically connect to a port or connector
of the thermal treatment system. The thermal treatment system receives
the solution bag and measures various conditions or parameters either
periodically or in response to changes in conditions (e.g., measures
conditions each predetermined time interval, in response to changing
conditions, etc.). The measured parameters are transmitted from
the thermal treatment system to processor 18, where the measured
conditions and time of measurement may be stored in the processor
(or an external) memory and/or displayed. The memory device may
further record locations (e.g., medical facility, etc.) and other
information (e.g., patient, solution and/or facility information,
etc.) received from the thermal treatment system. This information
may correspond with the time, temperature and/or other recordings
as described above. The location and other information may be entered
by a user via system input devices.
The interface may further facilitate communications between the
memory device and an external device 23 for downloading the recorded
information to that external device. In this case, external device
23 may be in the form of a processing device or system (e.g., computer
station or system, hand-held device, etc.). The recorded information
in the memory device may be downloaded at any time by the use of
the wireless transmitter/receiver or physical connector. A user
positions the solution bag to communicate with the external device
(e.g., in close proximity to the device for a wireless link, in
a manner enabling the connector to engage the external device port
or connector, etc.), where the external device instructs the memory
device to transmit the recorded information from memory. The interface
receives the instruction and forwards the request to the processor
to retrieve the desired information. The processor further controls
interface 20 to provide the information to the requesting device.
The information transmitted to external device 23 includes raw
data that is processed by the external device to produce a user
friendly format (e.g., a data sheet, a line graph that charts the
temperatures over time and location, etc.). The resulting information
may be presented on a screen for the user to view, printed for documentation
purposes or stored in a local or remote database accessible by users
or medical personnel as described above. The memory device may include
a unique identifier to associate the bag with the stored information
as described above. This enables locating or tracking of bags based
on stored location information, and ascertaining solution inventory
and availability as described above. The processor and/or interface
may utilize any conventional or other suitable protocol to communicate
with and transfer information with the external processing device
and thermal treatment system.
The processor may further include information associated with the
prescribed requirements and determine compliance with those requirements
based on the measured values as described above. This enables the
requirements to be programmable, where the memory device may be
used for any medical solutions and/or prescribed requirements. The
measured values and/or a compliance indication may be indicated
to medical personnel via display 12 and/or indicators 14. For example,
the processor may control the display to indicate the measured values,
prescribed requirements and/or an indication (e.g., message, symbol,
etc.) of non-compliance with those requirements as described above.
The indicators may be of different colors to indicate compliance
(e.g., a green LED), marginal compliance (e.g., a yellow LED) or
non-compliance (e.g., a red LED) with those requirements as described
above. The memory device may be disposable with the bag or re-programmed
for use with subsequent bags.
The solution bags described above include devices to basically
store measured conditions and other information for respective solutions
within those bags. Alternatively, the information for medical items
may be stored based on an item identifier in a central storage unit
or database accessible by users or medical personnel. A medical
item including an identifier in the form of a bar code is illustrated
in FIG. 5. Initially, medical item 2 is substantially similar to
the medical items described above and is preferably an intravenous
solution bag, but may be a wide variety of medical items (e.g.,
medical solution containers, saline solutions, IV solutions and/or
lines, instruments, blankets, antibiotics or other drugs, blood,
irrigation fluid and/or lines, etc.). Specifically, intravenous
solution bag 2 includes a generally triangular projection 4 attached
to and extending from the bag upper portion and including opening
or hole 6 defined therein as described above for interfacing an
intravenous pole or other support structure (not shown). The bag
lower portion includes an outlet 7 and associated fluid conduits
15 to interface an intravenous tube (not shown) and enable the solution
to flow through the tube from the outlet to a patient as described
above.
Solution bag 2 further includes a bar code 26 disposed on the bag.
The bar code includes a unique identifier associated with the bag
to identify the bag to a thermal treatment system treating the solution
bag. The thermal treatment system is configured to measure and transmit
warming cycle, time-temperature and/or other information (e.g.,
start date and start time of solution or other item heating/cooling,
the time interval the solution or other item was heated/cooled,
the temperature the solution or other item attained during heating/cooling
and/or the time and temperature of the solution or other item when
the solution was removed from the system (e.g., partial or complete
history of time and solution or other item temperature), doctor
information, type of procedure, type of instruments or other item
being heated/cooled, amount or quantity of solution or other item
being heated/cooled, etc.) to a central storage unit or database
accessible by users or medical personnel as described below. The
database may further receive the patient, solution and/or facility
information described above for the medical item (e.g., entered
by a user via thermal treatment system input devices or a workstation).
Bar code 26 is typically attached to or embedded within the bag
surface and may be disposed at any desired locations on the bag
via any conventional or other techniques (e.g., adhesive, welding,
lamination, etc.). For example, the bar code may be attached to
the bag during bag construction, where the bar code may be adhered
or sealed to the bag interior or exterior surface. The bar code
may be updated and reapplied to the solution bag to provide any
desired additional information (e.g., requirements, manufacturing
date, operational parameters, etc.).
A thermal treatment system receives the bag and includes a bar
code reader to ascertain the item identification as described below.
The thermal treatment system may include various sensors (e.g.,
proximity sensors, pressure sensors, temperature sensors (e.g.,
RTD, infrared, etc.), presence sensors, weight sensors, volume sensors,
flow sensors, fluid sensors, fluid level sensors, etc.) to measure
solution conditions and provides information (e.g., temperature,
heating intervals, time, humidity, etc.) for transfer to a central
storage unit. The thermal treatment system measures various conditions
or parameters either periodically or in response to changes in conditions
(e.g., measures conditions each predetermined time interval, in
response to changing conditions, etc.). The measured parameters
are transmitted from the thermal treatment system to a central storage
unit to record the measured conditions and information. A common
interface may be employed to permit a wide range of devices (e.g.,
ranging from thermal treatment systems, intelligent storage rooms,
workstations, etc.) to report information (e.g., the solution, patient
and/or facility information described above, etc.) related to the
treatment of each container (e.g., with a bar code) to a central
database. The thermal treatment system may further record item locations
(e.g., medical facility, storage facility, etc.) to correspond with
the recorded information as described above. The central storage
unit may be local or accessed by the thermal treatment system via
a network as described below. The transferred information may be
retrieved by users or medical personnel to monitor the solution
bag for compliance with the prescribed requirements. Further, the
stored information may be utilized for item tracking, inventory
and/or availability purposes as described above.
A medical item including an identifier in the form of a transponder
unit according to the present invention is illustrated in FIG. 6.
Initially, medical item 2 is substantially similar to the medical
items described above and is preferably an intravenous solution
bag, but may be a wide variety of medical items (e.g., medical solution
containers, saline solutions, IV solutions and/or lines, instruments,
blankets, antibiotics or other drugs, blood, irrigation fluid and/or
lines, etc.). Specifically, intravenous solution bag 2 includes
a generally triangular projection 4 attached to and extending from
the bag upper portion and including opening or hole 6 defined therein
as described above for interfacing an intravenous pole or other
support structure (not shown). The bag lower portion includes an
outlet 7 and associated fluid conduits 15 to interface an intravenous
tube (not shown) and enable the solution to flow through the tube
from the outlet to a patient as described above.
Solution bag 2 further includes an identifier in the form of a
transponder unit 28. The transponder unit provides a unique identifier
associated with the bag that identifies the bag to a thermal treatment
system treating that bag. The thermal treatment system is configured
to measure and transmit warming cycle, time-temperature and/or other
information (e.g., start date and start time of solution or other
item heating/cooling, the time interval the solution or other item
was heated/cooled, the temperature the solution or other item attained
during heating/cooling and/or the time and temperature of the solution
or other item when the solution was removed from the system (e.g.,
partial or complete history of time and solution or other item temperature),
doctor information, type of procedure, type of instruments or other
item being heated/cooled, amount or quantity of solution or other
item being heated/cooled, etc.) to a central storage unit or database
accessible by users or medical personnel as described below. The
database may further receive the patient, solution and/or facility
information described above for the medical item (e.g., entered
by a user via thermal treatment system input devices or a workstation).
The transponder unit may be attached to or embedded within the bag
surface and may be disposed at any desired locations on the bag
via any conventional or other techniques (e.g., adhesive, welding,
lamination, etc.). For example, the transponder unit may be adhered
or sealed to the bag interior or exterior surface.
Referring to FIG. 7, transponder unit 28 includes processor 18
and a transceiver 30. A power source (not shown), preferably in
the form of batteries, provides power to the components. Processor
18 is substantially similar to the processor described above and
controls operation of the transponder unit. Transceiver 30 facilitates
communications with an external device 21 in the form of a thermal
treatment system as described below that treats the solution bag.
The transceiver may be in the form of a conventional wireless transceiver
(e.g., RF, infrared, etc.) to communicate with a corresponding wireless
transmitter/receiver of the thermal treatment system.
The thermal treatment system receives the bag and includes the
wireless transmitter/receiver to receive transmissions from the
transponder unit to ascertain the item identification. The thermal
treatment system further includes various sensors (e.g., proximity
sensors, pressure sensors, temperature sensors (e.g., RTD, infrared,
etc.), presence sensors, weight sensors, volume sensors, flow sensors,
fluid sensors, fluid level sensors, etc.) to measure solution conditions
and provide information (e.g., temperature, heating intervals, time,
humidity, etc.) for transfer to a central storage unit. The thermal
treatment system measures various conditions or parameters either
periodically or in response to changes in conditions (e.g., measures
conditions each predetermined time interval, in response to changing
conditions, etc.). The measured parameters are transmitted from
the thermal treatment system to a central storage unit to record
the measured conditions and information. Alternatively, the transponder
unit may receive and store the measured parameters and other information
from the thermal treatment system in the processor (or an external)
memory as described above. A common interface may be employed to
permit a wide range of devices (e.g., ranging from thermal treatment
systems, intelligent storage rooms, etc.) to report information
(e.g., the solution, patient and/or facility information described
above, etc.) related to the treatment of each container (e.g., with
a transponder unit) to a central database. The thermal treatment
system may further record item locations (e.g., medical facility,
storage facility, etc.) to correspond with the recorded information
as described above. The central storage unit may be local or accessed
by the thermal treatment system via a network as described below.
The transferred information may be retrieved by users or medical
personnel to monitor the solution bag for compliance with the prescribed
requirements. Further, the stored information may be utilized for
tracking, inventory and/or availability purposes as described above.
The transponder unit may be disposable with the bag or re-programmed
for use with subsequent bags.
A medical item including electrochromic ink cells to indicate solution
compliance with prescribed requirements according to the present
invention is illustrated in FIG. 8. Initially, medical item 2 is
substantially similar to the medical items described above and is
preferably an intravenous solution bag, but may be a wide variety
of medical items (e.g., medical solution containers, saline solutions,
IV solutions and/or lines, instruments, blankets, antibiotics or
other drugs, blood, irrigation fluid and/or lines, etc.). Specifically,
intravenous solution bag 2 includes a generally triangular projection
4 attached to and extending from the bag upper portion and including
opening or hole 6 defined therein as described above for interfacing
an intravenous pole or other support structure (not shown). The
bag lower portion includes an outlet 7 and associated fluid conduits
15 to interface an intravenous tube (not shown) and enable the solution
to flow through the tube from the outlet to a patient as described
above.
Solution bag 2 further includes electrochromic ink cells 38 and
a control circuit 32 that monitors external and/or internal conditions
of the container environment and triggers individual electrochromic
cells in response to one or more conditions (e.g., max temperature
limit exceeded, max humidity exceeded, re-warming, solution expired,
etc.) to indicate compliance with prescribed requirements. Examples
of electrochromic ink cells that may be employed by the present
invention are disclosed in U.S. Pat. No. 6,294,111 (Shacklett, III
et al.), the disclosure of which is incorporated herein by reference
in its entirety. The ink cells may be of any quantity, shape or
size and may be disposed on a label 36 affixed to the bag. The label
may be of any size or shape with the ink cells being arranged thereon
in any fashion. The control circuit may include various sensors
and triggers an appropriate electrochromic cell upon conditions
specific to the contents of the bag being exceeded. One or more
cells are associated with a particular condition (e.g., a particular
temperature, humidity, a temperature or time interval exceeded,
passage of an expiration date, re-warming of the bag, etc.) to notify
a user or medical personnel of the occurrence of that condition.
The prescribed requirements may be programmed into the control circuit
based upon the specific contents of the bag to allow the requirements
to be tailored to the needs of the bag.
The ink cells and/or label may be attached to or embedded within
the bag surface and may be disposed at any desired locations on
the bag via any conventional or other techniques (e.g., adhesive,
welding, lamination, etc.). For example, the ink cells and/or label
may be adhered or sealed to the bag interior or exterior surface.
Referring to FIG. 9, control circuit 32 includes one or more sensors
16 and processor 18. A power source (not shown), preferably in the
form of batteries, provides power to the components. Processor 18
is substantially similar to the processor described above and controls
operation of the control circuit. The processor is coupled to sensors
16 and ink cells 38. Sensors 16 are preferably implemented by various
sensors (e.g., proximity sensors, pressure sensors, temperature
sensors (e.g., RTD, infrared, etc.), presence sensors, weight sensors,
volume sensors, flow sensors, fluid sensors, fluid level sensors,
etc.) to measure corresponding conditions (e.g., solution temperature,
humidity, etc.). The sensors may be disposed within the control
circuit or be external of the circuit within the solution bag to
measure the corresponding conditions. The measured parameters are
provided to processor 18, where the processor includes information
associated with the prescribed requirements. The processor determines
compliance with those requirements based on the measured values
to activate the appropriate ink cells associated with the condition.
The ink cells may be activated by the processor altering voltage
signals provided to these cells. Activation of the cell produces
a color change (e.g., change from one color to another, clear to
opaque, opaque to clear, etc.) to indicate conditions. This enables
the requirements to be programmable, where the ink cells and control
circuit may be used for any medical solutions and/or prescribed
requirements. The measured values and/or a compliance indication
may be indicated to medical personnel via the ink cells. For example,
the processor may control the ink cells to indicate the measured
values, prescribed requirements and/or an indication (e.g., message,
symbol, etc.) of non-compliance with those requirements.
The solution bag may alternatively include the ink cells with the
control circuit being disposed within an external device 21. The
external device may be in the form of a thermal treatment system
or a housing used to transport medical solutions or other sensitive
components. In this case, solution bag 2 includes the electrochromic
ink cells (and, preferably, text identifying the meaning of each)
and a conducting lead to an external location upon the bag where
a remote monitoring clip 39 can be attached to connect the electrochromic
cells to the external device. The external device monitors the bag
environment and provides control signals to activate selected electrochromic
cells on the bag to cause the corresponding electrochromic cell
to change color (e.g., from clear to opaque, from one color to another,
etc.) upon determining that allowable conditions have been exceeded.
This allows a user or medical personnel to view a visible identification
mark on the bag indicating that bag contents have exceeded allowed
storage conditions and may be compromised.
In addition, solution bag 2 may include one or more current source
buttons or switches 34 each associated with a corresponding electrochromic
cell to activate that cell (e.g., change color, etc.) as described
above. The buttons provide voltage signals to activate the corresponding
cell in response to actuation and basically serve as a manual over-ride
to allow a user or medical personnel to indicate and/or identify
the bag contents as compromised.
The medical items described above enable measurement and/or recordation
of medical item conditions from the manufacturing plant through
transport, storage, thermal treatment and/or administration to a
patient. This enables the medical item to be monitored at each or
any of the stages throughout the life of the medical item and to
notify users or medical personnel of compliance with prescribed
requirements. Thermal treatment systems thermally treating solution
bags (e.g., conventional solution bags or the bags described above)
or other medical items may monitor and/or record solution conditions
for compliance with the prescribed requirements according to the
present invention. In addition, the present invention may enable
control of thermal treatment system use. An exemplary medical item
thermal treatment system 100 to monitor and/or record medical item
conditions and/or employing usage control according to the present
invention is illustrated in FIG. 10. The system may thermally treat
a wide variety of medical items (e.g., medical solution containers,
saline solutions, IV solutions and/or lines, instruments, blankets,
antibiotics or other drugs, blood, irrigation fluid and/or lines,
etc.). Specifically, system 100 may be of any of the types of thermal
treatment systems disclosed in the aforementioned patents, patent
publications and patent applications and includes a temperature
controller 102, one or more heating/cooling units 104 and one or
more monitoring sensors 106 associated with each heating/cooling
unit. The heating/cooling units (and/or corresponding sensors) are
associated with a corresponding individual medical item or a system
compartment receiving medical items to be treated. The system may
further include a report unit 101 and a usage control unit 1001.
The report unit facilitates collection of measured information to
generate a report, while the usage control unit enables control
of system operation as described below.
Temperature controller 102 may be implemented by any conventional
or other controller or microprocessor (e.g., chip, card, processor,
circuitry, etc.) and controls heating/cooling units 104 to thermally
treat a corresponding system compartment and/or medical item to
a desired temperature. Monitoring sensors 106 are disposed in the
proximity of a corresponding heating/cooling unit 104 or medical
item to detect various conditions (e.g., the insertion, presence
and/or removal of a medical item within the system, the medical
item and/or heating/cooling unit temperature, etc.). Monitoring
sensors 106 may be implemented by any conventional or other sensors
(e.g., proximity sensors, pressure sensors, temperature sensors
(e.g., RTD, infrared, etc.), presence sensors, weight sensors, volume
sensors, flow sensors, fluid sensors, fluid level sensors, etc.)
to measure and provide any information, and are coupled to temperature
controller 102. The temperature controller and/or monitoring sensors
may be further coupled to report unit 101 and/or usage control unit
1001.
Temperature controller 102 typically includes input devices (not
shown) to receive a desired or set point temperature for each medical
item and/or system compartment from a user and a display (not shown)
to display the desired and/or measured temperatures for each medical
item and/or compartment. The temperature controller compares the
set point temperature for a medical item and/or compartment to the
corresponding measured temperature and controls the associated heating/cooling
unit accordingly to maintain the medical item and/or compartment
at or near the desired temperature. For example, the temperature
controller may disable heating (or enable cooling) in response to
a measured temperature exceeding a desired temperature. Conversely,
the temperature controller may enable heating (or disable cooling)
in response to a measured temperature below a desired temperature.
Heating/cooling units 104 may be implemented by any conventional
or other heating and/or cooling devices (e.g., heating pad or coils,
refrigeration coils, thermoelectric device, etc.).
Referring to FIG. 11, report unit 101 includes a report controller
108, interface 20, a printer 110, memory storage 112, a display
114 and/or a timer 120. The system includes devices to measure,
record and/or provide a report (e.g., hardcopy or electronic form)
of system conditions (e.g., time, date, temperature, fluid loss
or removal, etc.) as described below. The report provides medical
personnel documentation for their files on the heating/cooling characteristics.
The primary information produced is the start date and start time
of solution or other item heating/cooling, the time interval the
solution or other item was heated/cooled, the temperature the solution
or other item attained during heating/cooling and/or the time and
temperature of the solution or other item when the solution was
removed from the system (e.g., partial or complete history of time
and solution or other item temperature). The report may further
include a variety of information (e.g., doctor information, type
of procedure, type of instruments or other item being heated/cooled,
amount or quantity of solution or other item being heated/cooled,
etc.). Specifically, report controller 108 is coupled to temperature
controller 102 and receives various information (e.g., enablement/disablement
of units 104, temperature, etc.) related to thermal treatment of
the medical item. The report controller may receive any additional
information (e.g., the facility, patient and/or solution information
described above, doctor information, etc.) from medical personnel
or users via report controller input devices (not shown). The report
controller may be implemented by any conventional or other controller
or microprocessor (e.g., chip, card, processor, circuitry, etc.).
Alternatively, the temperature controller and report controller
may be implemented by a single controller (e.g., temperature controller
102).
The report controller further maintains the date, elapsed heating/cooling
time and occurrence time of an event or condition (e.g., the time
when medical items are inserted and/or removed from the system,
etc.). The time may be measured and/or displayed by the report controller
or by timer 120 as described below. The report controller may measure
the elapsed time or record an occurrence time based on signals received
from the temperature controller and/or input devices. For example,
the report controller may initiate measurement of a time interval
in response to the temperature controller indicating enablement
of heating/cooling units 104, and may store the elapsed and/or occurrence
time in response to any condition (e.g., when solution or other
item is removed). The report controller may further measure elapsed
time or record elapsed and/or occurrence time in response to medical
personnel manually entering information on the report controller
input devices (e.g., start and stop keys). The report controller
collects the appropriate information and arranges the information
into a report. The report may be arranged in any fashion and include
any desired information. The report controller may further provide
corresponding information to solution bag 2 via interface 20 as
described above. The interface may be in the form of a wireless
transmitter/receiver (e.g., RF, infrared, etc.) or a connector or
port to communicate with the solution bag as described above. Alternatively,
the interface may be in the form of a bar code reader to identify
a particular medical item and enable the report controller to transmit
corresponding information to a central database for review, tracking,
inventory and/or availability purposes as described above. Moreover,
the report and/or information may be stored in a memory device (e.g.,
local memory, removable memory, card, disk, etc.) for later retrieval
as described below. In addition, the report controller and/or timer
are coupled to display 114 to display the elapsed (or running) time,
report or any desired information to medical personnel. The information
displayed may be selected via report controller input devices, or
the display may include display controls (e.g., buttons, keys, etc.).
The report may further be printed by the report controller via printer
110. The printer, timer and display may be implemented by any conventional
or other printer, timing and/or display devices.
A memory storage device 112 is coupled to report controller 108
and is used to store the collected information. Basically, the report
controller logs records containing system information (e.g., the
date/time that a medical item is inserted into system 100, the date/time
that the medical item is removed from the system, temperatures,
etc.). In this manner, use of the medical item warming/cooling system
is documented with recorded log entries. Log triggering events can
be user defined via report controller input devices that allow the
system to be configured to record information in response to a wide
variety of detected conditions and/or at particular times or periodic
intervals. The memory storage can be used to store a wide variety
of information related to use of the system and the thermal treatment
of individual medical items and can be any type of storage media.
For example, memory storage device 112 can include, but is not limited
to, an electronic memory chip, a smart card, a floppy disk, a fixed
or removable magnetic disk. The report controller may be configured
to support one or more of those memory storage types.
The system may record information regarding each medical item placed
in the system. The information collected and/or recorded by the
report controller and/or produced in a report can include, but is
not limited to: the date/time that a medical item was placed into/removed
from the medical item warming/cooling system, the temperature of
the medical item upon being placed into/removed from the medical
item warming/cooling system, the temperature of the medical item
at specific points in time while stored in the medical item warming/cooling
system, start date and time that the medical item began to be heated/cooled,
the length of time that the medical item was heated/cooled, the
temperature that the medical item was heated/cooled to during the
heating/cooling cycle and/or the amount of solution or other item
residing, placed in or removed from the system. The report may also
include related information, such as patient information (e.g.,
name, identification number and/or the other patient information
described above), facility information (e.g., name, location and/or
the other facility information described above), doctor information,
the type of procedure, the solution information described above,
the type of item being heated/cooled, the amount or quantity of
fluid or other item being heated/cooled (e.g., fluid (or other item)
level, volume or weight), the flow rate of fluid that is being heated/cooled,
the pressure of fluid flow as the fluid is heated/cooled and any
other desired information. The thermal treatment system may employ
any type of sensors or sensing devices (e.g., temperature sensors,
presence sensors, weight sensors, volume sensors, pressure sensors,
flow sensors, fluid sensors, fluid level sensors, etc.) as described
above to measure and provide any desired information to the report
controller for inclusion in a report. The recordation or collection
may occur automatically or via user entered information (e.g., start,
stop and/or record keys) as described above.
Report controller 108 stores and retrieves information from memory
storage 112 in order to produce a report with any desired information.
The report may be transmitted to printer device 110 that may be
integrated within medical warming/cooling system 100. The report
may further be displayed by the report controller on display 114.
The printer basically provides a report in hardcopy form. The report
controller may control the printer to produce the report at specified
times (e.g., termination of heating/cooling, at particular times
of day, after a particular quantity of uses, etc.) or in response
to requests from medical personnel via report controller input devices
(e.g., print key). The printer may print the report on any desired
hardcopy medium. Preferably, the printer places the information
onto a label that may be attached to a medical file and/or to the
medical item. The information may be printed during or after the
item heating/cooling, or be stored on a memory device and printed
at a desired time as described above. The printer may further provide
additional copies of the report in response to user requests, or
a medium automatically creating duplicates may be utilized (e.g.,
carbon-less paper, etc.).
The report or other information may alternatively be provided in
electronic form. The report controller may facilitate communication
with other devices for transference or downloading of the report
or other information to those devices. For example, the information
may be downloaded or transmitted over a network or other communications
medium to another device (e.g., PDA, computer, another thermal treatment
system, etc.) for viewing, storage and/or printing. Further, the
report controller may transmit the report or other information to
solution bag 2 via interface 20 or identify the solution bag or
other medical item via an identifier (e.g., bar code or transponder)
and transfer corresponding information to a central database as
described above. An externally attached device can be connected
to warming/cooling system 100 via a direct local connection or via
a network connection. Network connections to report controller 108
can include any combination of cable-based or radio-based local
area network (LAN), wide area network (WAN), or Internet network
links. The external local device or network connection can use a
cable-based or radio-based connection to a port, or network card,
on system 100. Moreover, the report controller may facilitate retrieval
of information (e.g., the patient, facility and/or solution information
described above, doctor information, item (e.g., instrument, etc.)
information, etc.) from a database, network or other source for
the report.
Report controller 108 is capable of transmitting generated reports
or any desired information to internally mounted printer 110, a
locally connected external printer 204, a locally connected personal
digital assistant (PDA) 206 and/or a locally connected computer
workstation 208 (e.g., including or coupled to the central database
storing medical item information). Further, report controller 108
is capable of transmitting generated reports via a LAN/WAN/Internet
network 210 to remotely connected devices, such as a network connected
printer 212 and/or a network connected computer workstation 214
(e.g., including or coupled to the central database for storing
medical item information). In addition, plural systems 100 may be
coupled to a network to enable a workstation to access the system
reports or medical item information remotely (e.g., via a LAN, Internet
server or website, etc.) to enable monitoring of medical item compliance
with prescribed requirements.
Information is collected by report controller 108 and stored in
memory storage 112, typically in real-time, as events occur. Reports
or medical item information can be generated and printed/displayed
or transmitted (e.g., to the medical item, external devices or databases,
etc.) in a timely manner to allow a local or remote (e.g., at network
workstation or computer 214) user to monitor the status of one or
more systems and the status of medical items undergoing thermal
treatment. Alternatively, reports or other information can be generated
and printed/displayed or transmitted at a time of a user choosing.
For example, a user either local to or remote from a system is able
to monitor the temperature of medical items and the time that medical
items have been stored within a medical item warming/cooling system
based upon reports printed or shown on a display device. The user
may access stored information relating to one or more medical item
warming/cooling systems 100 by requesting (e.g., via report controller
input devices, a remote workstation, etc.) that a report be produced
or displayed to a specific printer or display (e.g., local or remote).
Further, the information stored by the medical item or solution
bag 2 may be downloaded to an external device as described above
to monitor conditions.
The present invention generates and/or transmits reports to a display,
printer, medical item or external device based upon concurrently
monitored information, or based upon information stored within a
memory storage device. The printed reports or transmitted information
create a permanent log record that documents events that occur within
the medical item warming/cooling system. Thus, a valuable, previously
unavailable source of historical information is available to doctors,
nurses, technicians, and hospital staff for use in support of patient
record keeping, compliance with medical standards, scheduling routine
maintenance, detecting malfunctioning devices, assessing costs to
a specific operating team or medical patient, and adjusting the
number and types of medical item warming/cooling systems to meet
demand based upon actual use. The reports or information may be
generated, displayed, transmitted and/or printed at particular times
or concurrently with system operation (e.g., as information is measured
and/or collected) to provide current system information (e.g., the
printouts and/or displays may be updated continuously with report
information).
An exemplary report of information that may be produced by report
controller 108 and transmitted to and/or printed or displayed on
locally or remotely connected devices (e.g., display, medical item,
printer, etc.) is illustrated in FIG. 12A. The report can include
a wide variety of information. Exemplary report information may
include medical item warming/cooling data 302 (e.g., type of item/fluid,
intended use, start date, start time, duration, start temperature,
removal temperature, fluid flow pressure (if applicable) and/or
the other solution information described above). Other exemplary
report information may include patient information 304 (e.g., patient
name, patient id#, blood type and/or the other patient information
described above), warming/cooling system information 306 (e.g.,
warming/cooling system ID, warming/cooling chamber ID, warming/cooling
system serial number, manufacturer's number, last inspected date,
inspected by and next inspection date), facility information 308
(e.g., facility name, facility location, doctor's information, type
of procedure and/or the other facility information described above)
and report metadata 310 (e.g., data collected date/time, report
generation date/time and operating technician).
The report controller may provide any desired information (or any
portions of the information to provide a more consolidated report)
arranged in any fashion. For example, the report or transmitted
information can include only a system ID number and select item
warming/cooling data. The report can be adapted to display a wide
variety of information that addresses a wide variety of warming/cooling
system configurations. Further, generated reports will vary depending
upon the configuration and use of the respective medical item warming/cooling
systems and the information desired for a medical item. The information
can be displayed locally or upon any printer/display connected to
the medical item warming/cooling system. Further, information stored
in a medical item may be downloaded as described above.
Alternative exemplary reports are illustrated in FIGS. 12B-12I.
The reports of FIGS. 12B-12C include the date (e.g., month, day
year (MM/DD/YY) or any other desired format), current time (e.g.,
hours and minutes (HH:MM) or any other desired format), start and
end time (e.g., hours and minutes or any other desired format) of
item heating/cooling and item temperatures at various points in
time. The item temperatures are arranged, by way of example only,
in a columnar format. The times may be at any desired periodic intervals
or in response to a particular condition. For example, reports for
IV solution warming (e.g., FIGS. 18, 21, 22, 27A and 30) or open
basin (e.g., FIG. 20) type systems may indicate the temperature
of solution or solution containers measured at any desired time
interval (e.g., fifteen minutes, two minutes, one minute, etc.).
Alternatively, reports for an open basin type system (e.g., FIG.
20) may indicate the time and temperature of solution when the solution
is removed or scooped from the basin. These reports may further
indicate the amount of solution residing, placed in and/or removed
or scooped from the basin.
The reports of FIGS. 12D-12I generally provide time and temperature
information in graphical form. In particular, these reports include
the date (e.g., month, day year (MM/DD/YY) or any other desired
format), current time (e.g., hours and minutes (HH:MM) or any other
desired format) and graphs showing solution or other item temperature
in relation to time. The graphs include an abscissa or `X` axis
associated with time and an ordinate or `Y` axis associated with
temperature. The time axis may extend for several hours (e.g., FIGS.
12D and 12F-12H) or for a particular time interval or time of day
(e.g., FIGS. 12E and 12I). A series of temperature symbols (e.g.,
dots) are placed on the graph to indicate the temperature of solution
or other item at a given time (e.g., FIGS. 12D and 12F). The temperature
symbols may be connected by or reside on a line (e.g., FIG. 12G),
or the line may be utilized (without the temperature symbols) to
provide a continuous report of time and temperature (e.g., FIGS.
12E, 12H and 12I). In addition, a removal symbol (e.g., diamond)
may reside in the line (e.g., FIGS. 12E, 12G-12I) or series of temperature
symbols (e.g., FIGS. 12D and 12F) to indicate times when solution
or other items are removed. The time of removal may be indicated
by reference lines extending from the removal symbols to the time
axis (e.g., FIG. 12H), or by placing the actual removal time (e.g.,
in hours and minutes (HH:MM) or any other desired format) proximate
the removal symbol (e.g., FIG. 12I). These reports are typically
utilized by open basin type systems (e.g., FIG. 20), where the reports
may further indicate the amount of solution residing, placed in
and/or removed or scooped from the basin. However, the reports may
be utilized by any types of medical item thermal treatment systems,
such as those disclosed in the aforementioned patents, patent publications
and patent applications. The reports described above may be printed,
transmitted and/or displayed at particular times or continuously
and updated as data is collected (e.g., the graphs and/or columns
may be updated with information as time progresses, etc.). The continuous
reports are generally utilized for IV warming type systems and medical
items (e.g., bag or line warmers, medical items, solution bags,
etc.) to provide a continuous printout, display or history of item
temperature, but may be utilized with any medical item thermal treatment
system.
Usage control unit 1001 enables control of thermal treatment system
use. Referring to FIG. 13, usage control unit 1001 includes an information
device system interface 1008, an information device 1010 with storage
or memory 1012, display 114 and/or timer 120.
Information device 1010 is preferably in the form of a chip or
integrated circuit, but may be implemented by any type of device
including a memory or storage (e.g., a microprocessor with memory,
a chip, a floppy, magnetic or optical disk, CD-ROM, USB disk, smart
card, etc.). The information device (e.g., chip) is typically provided
to a user by a system service provider for installation in the thermal
treatment system. Basically, the user plugs the information device
into a receptacle on or within the system to couple the information
device to system interface 1008. However, the coupling between the
system interface and information device may be accomplished in any
fashion (e.g., direct connection, infrared, RF transmission, cellular,
Bluetooth, etc.). The system interface collects information from
temperature controller 102 and/or monitoring sensors 106 during
system operation and stores the collected information on information
device 1010, preferably in storage device or memory 1012. The system
interface may be implemented by any conventional or other device
(e.g., microprocessor, controller, processing system, chip, circuitry,
read/write unit, etc.) capable of collecting information and transferring
data with information device 1010 and/or storage 1012.
The system interface is preferably disposed within the thermal
treatment system; however, the interface may be disposed external
of the thermal treatment system and coupled to the system via any
desired medium (e.g., cable, wireless, etc.). The system interface
may further maintain the date, elapsed heating/cooling time and/or
occurrence time of an event or condition (e.g., the time when medical
items are inserted and/or removed from the system, etc.). The system
interface may measure the elapsed time or record an occurrence time
based on signals received from the temperature controller, monitoring
sensors and/or system interface input devices. For example, the
system interface may initiate measurement of a time interval in
response to the temperature controller indicating enablement of
heating/cooling units 104, and may store the elapsed and/or occurrence
time in response to any condition (e.g., when solution or other
item is removed). The system interface may further measure elapsed
time or record elapsed and/or occurrence time in response to medical
personnel manually entering information on the system interface
input devices (e.g., start and stop keys). Alternatively, timer
120 may maintain elapsed time and provide timing information to
the system interface and/or display.
The system interface collects the appropriate information and arranges
the information for storage in memory 1012. The collected information
may be arranged in any fashion and include any desired information.
The system interface may collect and store a wide variety of information
in storage 1012 related to the use of the thermal treatment system
and the warming/cooling of individual medical items. For example,
information pertaining to each medical item may be individually
recorded and include: the date/time that a medical item was placed
into/removed from the medical item warming/cooling system, the temperature
of the medical item upon being placed into/removed from the medical
item warming/cooling system, the temperature of the medical item
at specific points in time while stored in the medical item warming/cooling
system, start date and time that the medical item began to be heated/cooled,
the length of time that the medical item was heated/cooled, the
temperature that the medical item was heated/cooled to during the
heating/cooling cycle and/or the amount of solution or other item
residing, placed in or removed from the system.
The system interface may also store related information in memory
1012, such as patient information (e.g., name, identification number
and/or the other patient information described above), thermal treatment
system information (e.g., type, identification or serial number,
etc.), user information (e.g., access or account identification
or code, passwords, etc.), facility information (e.g., name, location
and/or the other patient information described above), doctor information,
the type of procedure, the solution information described above,
the type of solution or other item being heated/cooled, the amount
or quantity of fluid or other item being heated/cooled (e.g., fluid
(or other item) level, volume or weight), the flow rate of fluid
that is being heated/cooled, the pressure of fluid flow as the fluid
is heated/cooled and any other desired information. The thermal
treatment system may employ any type of sensors or sensing devices
(e.g., temperature sensors, presence sensors, weight sensors, volume
sensors, pressure sensors, flow sensors, fluid sensors, fluid level
sensors, etc.) to measure and provide any desired information to
the system interface for inclusion on information device 1010. The
related information (e.g., user, system, facility, patient and/or
doctor information, etc.) may be pre-stored on the information device
and/or entered by a user via system or interface input devices (e.g.,
keypad, etc.). The recordation or collection of information by the
system interface may occur automatically or via user entered information
(e.g., start, stop and/or record keys) as described above. In this
manner, storage 1012 is used to document use of the medical item
thermal treatment system with recorded log entries. Logged event
data may be user defined and/or pre-configured and may be generated
in accordance with a periodic schedule and/or in response to a wide
variety of events.
Generally, the information stored by the system interface in storage
1012 depends upon the particular type of thermal treatment system
and corresponding sensors employed. For example, information collected
and stored for IV solution warming (e.g., FIGS. 18, 21, 22, 27A
and 30) or open basin (e.g., FIG. 20) type systems may include the
temperature of solution or solution containers measured at any desired
time interval (e.g., fifteen minutes, two minutes, one minute, etc.).
Alternatively, the information stored for an open basin type system
(e.g., FIG. 20) may include the time and temperature of solution
when the solution is removed or scooped from the basin. The stored
information may further indicate the amount of solution residing,
placed in and/or removed or scooped from the basin.
The stored information may be retrieved or downloaded from information
device 1010 and printed to generate a hardcopy report of thermal
treatment system activity as described below. The report preferably
becomes the permanent record of the thermal treatment system for
later review. Further, the information from storage 1012 may be
uploaded to one or more other storage devices as part of a permanent
archive.
System interface 1008 may further retrieve usage and control parameters
from memory 1012 and coordinate with temperature controller 102
to control operation of medical item thermal treatment system 100
in accordance with the retrieved parameters. The usage and control
parameters are typically stored on information device 1010 by the
service provider and may include: a calendar/time period during
which the medical item thermal treatment system is authorized for
use; a number of warming/cooling cycles for which the medical item
thermal treatment system is authorized for use; a number of medical
items for which the medical item thermal treatment system is authorized
for use; type of use (e.g., heating, cooling, heating and cooling,
etc.); a user access code; type of medical item accepted; a desired
temperature for medical items; a maximum duration that a medical
item (e.g., IV solution , blood, etc.) is allowed to remain in the
thermal treatment system; time and/or temperature thresholds to
be used in controlling alarms; log event definitions; timeouts;
timer periods; various threshold values; log messages; storage destinations;
etc.
The usage parameters enable a user to lease or rent use of the
thermal treatment system based on various metrics (e.g., quantity
of heating/cooling cycles, quantity of blocks or intervals of time,
quantity of medical items, etc.). For example, usage parameters
retrieved from storage 1012 may enable use of a medical item thermal
treatment system for a specific number of warming/cooling thermal
treatment cycles or for a particular time duration. Prior to initiating
an activity (e.g., a heating/cooling cycle for a medical item),
temperature controller 102 communicates with system interface 1008
to request authorization to initiate the activity. The authorization
request typically includes a description of the type of activity
(e.g., a heating/cooling cycle) and other relevant information (e.g.,
the heating/cooling unit to be used) for which verification of authorized
use is requested. Upon receipt of the authorization request, system
interface 1008 checks usage parameters stored in storage 1012 to
determine whether the requested activity can be performed. If the
usage parameters indicate the requested activity may be performed
(e.g., sufficient quantity of cycles or time intervals exist), system
interface 1008 enables temperature controller 102 to perform the
activity (e.g., provides control signals to enable the temperature
controller). Otherwise, if the usage parameters indicate the requested
activity may not be performed, system interface 1008 disables temperature
controller 102 (e.g., provides control signals to disable the temperature
controller).
The usage parameters are updated in accordance with system use
to control usage of the system. For example, the quantity of cycles
or time interval stored on the information device may be updated
(e.g., incremented or decremented) to indicate remaining system
usage enabled by the information device. The system typically includes
a display 114 coupled to the system interface that displays the
remaining amount of system usage indicated by the usage parameters
stored on the information device (e.g., remaining time or quantity
of cycles). Upon exhausting the amount of use authorized by the
usage parameters, the display notifies an operator that a new information
device (e.g., chip) is needed. This may be accomplished by audio
and/or visual indicators (not shown). The user orders a new information
device from the service provider and removes the current information
device for forwarding to the service provider. The data stored on
the information device is retrieved and processed by the service
provider to generate reports of system activity for the user (e.g.,
in various forms, such as hardcopy, e-mail, storage media (e.g.,
CD-ROM, floppy, etc.), fax, etc.). The retrieved information may
also be stored for later retrieval. The information device may be
re-programmed by the service provider to enable use of a thermal
treatment system in accordance with the revised usage and control
parameters on the information device as described above
In operation, a service provider provides a user with information
device 1010, preferably in the form of a chip. The information device
(e.g., chip) is pre-programmed with usage and/or control parameters
to control operation and usage of the thermal treatment system as
described above. The user installs the information device on or
in the thermal treatment system, where the information device is
coupled to system interface 1008. Medical items are inserted into
the thermal treatment system, where the user operates the system
to thermally treat the items. The system interface retrieves the
appropriate parameters from the information device and controls
the temperature controller accordingly as described above. The remaining
usage authorized by the information device is typically displayed
on display 114 as described above.
During thermal treatment of the items, the usage parameters and
display are updated. Further, system interface 1008 collects various
information from temperature controller 102 and/or sensors 106 and
stores this information on information device 1010. When sufficient
information has been stored on information device 1010 or other
condition occurs (e.g., expiration of usage, completion of system
activity, etc.), the information device is removed from the system
and forwarded to the service provider. The service provider retrieves
and processes the collected information to generate reports for
the user and re-programs the information device (e.g., revises the
usage parameters) for additional use as described above. Alternatively,
collected information may be formed into reports (e.g., FIGS. 12A-12I)
by report unit 101 as described above, where the reports or information
can be transmitted to internal printer 110, display 114 or to a
local or remote external device (e.g., printer, display, database,
medical item, etc.) as described above.
An alternative embodiment of usage control unit 1001 employing
a computer system to access collected information on the information
device is illustrated in FIG. 14. Specifically, usage control unit
1001 is substantially similar to the unit described above and includes
information device system interface 1008, display 114 and/or timer
120. Information device 1010 is in the form of a "smart"
card and includes storage 1012. The card typically includes a plastic
or paper substrate that houses storage 1012 and accompanying components
(e.g., processor, circuitry, etc.). System interface 1008 is substantially
similar to the system interface described above and transfers information
with information device 1010. The information device (e.g., card)
is sent to a user, preferably once, by a service provider with usage
and control parameters stored thereon. The information device is
received by the thermal treatment system and coupled to the system
interface as described above, where the system functions as described
above to collect information and store the information on information
device 1010. Further, the system interface controls operation and
use of the system in accordance with the usage and control parameters
as described above.
When sufficient information has been stored on information device
1010 during system use or other condition occurs (e.g., expiration
of usage, completion of system activity, etc.), information device
1010 is removed from system 100 to retrieve and process the collected
information stored thereon. The stored information may be retrieved
by a workstation or computer system 1004. A computer interface 1002
is coupled to computer system 1004 and receives or interfaces information
device 1010. The computer interface may be disposed within or be
external of the computer system. Interface 1002 is substantially
similar to system interface 1008 and transfers information with
information device 1010. The computer system retrieves the collected
information from the information device (e.g., card) via interface
1002 and processes the information to generate reports. A user typically
communicates by telephone (or other manner) with the service provider
to ascertain a password to enable retrieval of the stored information
by the computer system. Basically, the computer system may provide
a user interface to enable a user to enter a password and then retrieve
the information. A printer 1018 may be connected directly to computer
system 1004 or be accessible via a network 1011 (e.g., LAN/WAN/Internet,
etc.) to print the generated reports. Further, the password may
enable the computer system to replenish the card (e.g., revise the
usage parameters) to facilitate further use of a thermal treatment
system. In other words, the computer system and computer interface
may reprogram information device 1010 with the next password and
other information for subsequent use.
Computer system 1004 may further be in communication with a remote
server computer system 1009 via network 1011 (e.g., LAN/WAN/Internet,
etc.). The server system is coupled to an information base 1015.
In this case, information device 1010 is removed from system 100
and inserted into or coupled to computer interface 1002 as described
above. Information stored on the information device (e.g., card)
may be retrieved by computer system 1004 as described above and
transferred to remote server system 1009 via network 1011 for storage
in information base 1015. A user may visit a specific or service
provider web site via computer system 1004 to download information
from the information device to the server system for generation
of reports and/or storage at the service provider or a user secure
web site for later processing. The reports may be generated via
the server system or web site and printed by printer 1018 that may
be coupled to computer system 1004 and/or the network. Information
device 1010 may be reprogrammed by computer interface 1002 and computer
system 1004 in accordance with the server system or web site to
facilitate additional use of a thermal treatment system (e.g., usage
and/or control parameters may be updated) as described above. The
user may receive a bill for the additional usage from the service
provider.
Once the user completes the desired actions via computer system
1004, information device 1010 is removed from interface 1002 and
received by system 100. System interface 1008 reads the usage and/or
control parameters to control use and operation of the thermal treatment
system as described above.
Yet another embodiment of usage control unit 1001 in communication
with a network is illustrated in FIG. 15. Specifically, usage control
unit 1001 includes display 114, a communications device 1014 and/or
timer 120. The communications device is in communication with a
network 1011 (e.g., LAN/WAN/Internet, etc.) and coupled to temperature
controller 102, display 114 and/or timer 120. The communications
device may be implemented by any conventional or other processing
and/or communications devices (e.g., router, modem, processing system,
microprocessor, controller, etc.) and basically performs the functions
substantially similar to those performed by system interface 1008
described above of collecting information pertaining to system activity
from the temperature controller and/or sensors and monitoring and
controlling system use based on control and usage parameters. The
communications device further transfers that information over the
network. The thermal treatment system operates as described above
to thermally treat medical items and collect information pertaining
to system activity and usage. Communications device 1014 may store
collected information and/or parameters in a memory 1016, where
the collected information is transmitted over network 1011 to a
server computer system 1020 for storage in an associated information
base 1030. The server system is coupled to network 1011 and basically
serves as a host system to collect information from the thermal
treatment system and store that information in information base
1030.
The server system further provides the thermal treatment system
with usage and control parameters to enable the communications device
to monitor and control system use as described above. A user may
access the server system via a workstation or computer system 1004
coupled to network 1011 in order to retrieve and process the collected
information to generate reports. The server system typically provides
a user interface, preferably in the form of a service provider web
site, to facilitate these user functions. The reports may be printed
via a printer 1018 coupled to network 1011 or computer system 1004.
A service provider may control access to the web site and/or system
data based on various techniques (e.g., passwords, subscriptions,
accounts, etc.). Thus, the thermal treatment system may monitor
and control use via server system 1020 and information base 1030
without use of an information device. Alternatively, the usage control
unit may further include system interface 1008 and information device
1010, each as described above, where the communications device is
further coupled to the system interface and serves to transfer information
between that interface and the network. The information device may
contain various information (e.g., user or system identification,
usage information, etc.) and receive collected information as described
above. The information stored on the information device may be transferred
to the server system to enable a user to retrieve information via
the web site. In addition, the control and usage parameters stored
on the information device may be revised (e.g., replenish usage,
etc.) by the system interface in accordance with actions by a user
on the web site. The information store and information device may
contain or receive any information in any desired combination.
The medical item thermal treatment system may transfer information
to server system 1020 for storage within information base 1030 in
real-time, as events occur. This allows a user at workstation 1004
to monitor the status of one or more medical item thermal treatment
systems and the status of medical items undergoing a warming/cooling
cycle via displays or reports generated from real-time and/or historic
data contained within the information base. For example, a user
within an operating room, or remote to an operating room, can monitor
one or more medical item thermal treatment systems. Information
within the information base can be queried using information base
query techniques or displayed via a dynamically updated user interface
viewed at workstation 1004 that presents the user with a selected
view of one or more medical item thermal treatment systems. Visible
and/or audible alarms may alert the user to conditions that exceed
established control parameters or prescribed requirements. By way
of example, if a medical item solution exceeds a predetermined temperature,
or has maintained a temperature for a period of time that exceeds
a user configurable maximum value, the user can be alerted in real-time
as the conditions occur and take corrective action, as necessary.
Further, usage and control parameters may be updated within the
information base by a user, via the web site, and immediately downloaded
to the affected medical item thermal treatment system in real-time,
or upon occurrence of a scheduled or event based trigger. For example,
a user can review the use remaining on one or more medical item
thermal treatment systems 100, and authorize additional blocks of
use, as necessary. Use can be authorized using a service provider
dynamic user interface or web site displayed at workstation 1004.
Payment for additional use can be coordinated directly with the
service provider, by phone, or via a conventional debit/credit based
electronic transaction.
The manner in which a medical item thermal treatment system monitors
and controls system use or activities according to the present invention
is illustrated in FIG. 16. Specifically, thermal treatment system
100 (FIGS. 13-15) is enabled at step 1032 and receives, at step
1034, usage and control parameters (e.g., log event definitions,
timeouts, timer periods, initial usage values, threshold values,
log messages, storage destinations, etc.) from a source (e.g., information
device 1010, a server system, etc.) as described above. The thermal
treatment system applies the received parameters, at step 1036,
to monitor and control system use. Next, the medical item thermal
treatment system waits, at step 1038, for insertion of a medical
item or receipt of revised parameters. If a medical item is received,
at step 1040, and the system, at step 1044, determines that usage
remains available, the thermal treatment system proceeds, at step
1050, to initiate a warming/cooling cycle based upon the operational
control and/or usage parameters received in step 1034.
If, at step 1040, a medical item is not received and the system
determines, at step 1042, that revised control and/or usage parameters
are received, operation returns to step 1036, where the revised
parameters are applied.
If, at step 1044, the usage parameter values have fallen below
a predetermined threshold, operations can be terminated, at step
1046, or an alert can be generated for the user and logged, at step
1048, prior to proceeding with a warming/cooling cycle, at step
1050.
Once the thermal treatment system proceeds with a warming/cooling
cycle for a medical item, at step 1050, the thermal treatment system
monitors heating/cooling events, sensor values and/or system timers.
Upon occurrence of a defined event or a predetermined timeout period,
at step 1052, the thermal treatment system, at step 1054, generates
and stores a log entry and/or updates stored values used to monitor
and track usage and other system status values. Upon handling the
log event, the thermal treatment system proceeds with the warming/cooling
cycle, at step 1050, and continues to monitor/log events, at steps
1052, 1054 until the medical item warming/cooling cycle is complete,
at step 1056. At step 1058, the medical item thermal treatment system
updates usage parameter values (e.g., remaining usage time, warming/cooling
cycle counters, etc.). If a power down of the system is initiated,
at step 1060, operations cease; otherwise, operations proceed to
step 1038, and the system waits for insertion of a new medical item
or revised parameters as described above.
The manner in which monitoring and control of system use is accomplished
via a local or remote computer system according to the present invention
is illustrated, by way of example only, in FIG. 17. Specifically,
workstation or computer system 1004 (FIGS. 14-15) or any other network
or locally connected device initiates, at step 1062, a user interface
and, at step 1064, establishes a connection with medical item thermal
treatment system information base 1004, 1030 or information device
1010 provided by the user as described above.
Once a connection is established, a user can choose, at step 1066,
to generate a display or report that contains information about
system use. A user may select one or more medical item thermal treatment
systems for which information is to be included in the display or
report when accessing the information store. At step 1070, the user
selects the display or report to be generated. The display or report
generated can be displayed and/or printed, at step 1072, to one
or more local or network connected display devices and/or printers.
If one or more medical item thermal treatment systems support a
real-time network interface with the medical item thermal treatment
system information base, a user can request real-time monitoring
of events and/or monitored parameters. In particular, the user chooses,
at step 1074, to monitor operations in real time, and selects, at
step 1076, one or more medical item thermal treatment systems for
which information is to be included in the real-time display. Next,
the user selects, at step 1078, a display format that supports the
information the user is interested in monitoring and initiates,
at step 1080, the real-time monitoring process. As a result, the
selected display is presented and updated in real-time as relevant
information changes within the medical item thermal treatment system
information base. The display may be printed to provide reports
of conditions at various times.
A user can select, at step 1082, to authorize additional medical
item thermal treatment system usage. The user may select one or
more medical item thermal treatment system(s) to which usage is
to be added when accessing the information base. At step 1086, the
user selects the usage-policy/usage-amount to be added to the medical
item thermal treatment system based upon the information displayed,
and a payment method, such as a debit or credit account. The user
finalizes the usage transaction, at step 1088, upon which authorized
use parameters in the information base or stored on information
device 1010 are updated.
A user can select, at step 1090, to change one or more control
parameters. The user may select one or more medical item thermal
treatment systems to which control parameters are to be updated
when accessing information store 1030. At step 1094, the user selects
and updates the associated user controlled parameters. The user
finalizes, at step 1096, the change control parameters transaction,
thereby updating control parameters in the information base and/or
information device. The control parameters can be used to define
log events, log event messages, log event heartbeat timers, control
point decisions, etc., depending upon the monitoring and control
capabilities supported by the respective medical item thermal treatment
systems as described above.
Thermal treatment system 100 (e.g., monitoring conditions, transmitting
and/or printing information, etc.) may be in the form various thermal
treatment systems for heating/cooling and/or delivering fluids (e.g.,
open basin warmer/cooler, IV bag or bottle warmer/cooler, irrigation
bag or bottle warmer/cooler, IV fluid line warmer/cooler, irrigation
fluid line warmer/cooler, a hand piece delivery warmer/cooler, an
instrument and/or disposable fluid heating/cooling system (e.g.,
Hotline, Ranger or Cincinnati Sub Zero systems, etc.), etc.). By
way of example only, a medical item warming/cooling system 400 with
monitoring, transmission, printout and/or usage control capabilities
is illustrated in FIGS. 18-19. The system is of the type disclosed
in U.S. Pat. No. 6,660,974 (Faries, Jr. et al.). Specifically, medical
item warming/cooling system 400 includes a housing 402, an access
door 404 with a handle 406, a compartment 407 and a control panel
area 408. The system may stack vertically upon other medical item
systems using detents 410 in the top of housing 402 and protrusions
412, protruding from the bottom of housing 402 to align vertically
stacked system units.
Control panel area 408 typically includes a power switch 414 and
a display 416 with control buttons 418 used by a user to enter selections
into the system. System operation is typically controlled by a temperature
controller in accordance with a set point temperature entered by
a user and temperatures measured by a temperature sensor as described
above. The system typically employs heated air to heat medical items
placed within compartment 407.
Solution bags (e.g., conventional solution bags or the solution
bags described above) or other medical items are disposed within
a drawer 434 (FIG. 19) for insertion into compartment 407. Drawer
434 includes a series of receptacles 480 each for receiving a corresponding
medical item. The receptacles may include a series of monitoring
assemblies 420 to monitor the temperature and residence time (e.g.,
amount of time an item resides within the warmer unit) of individual
medical items heated within the warmer unit. Specifically, monitoring
assemblies 420 are each mounted below the approximate center of
a receptacle floor portion of a corresponding receptacle 480, where
the monitoring assemblies may be mounted to the drawer via any suitable
mounting devices (e.g., clamps, brackets, adhesives, etc.). The
monitoring assemblies each include an item sensor or switch 422
to detect when a medical item is placed within a corresponding receptacle
480 and a temperature or other sensor 424 to directly measure the
temperature or other conditions of the medical item within that
receptacle.
The system includes a configuration similar to that described above
for system 100 and may further include report unit 101 and/or usage
control unit 1001 to generate, transmit and/or print reports and/or
control system usage as described above for system 100. An interface
20 may be disposed in a receptacle in the form of a wireless transmitter/receiver
(e.g., RF, infrared, etc.), bar code scanner or connector or port
to communicate with the medical item and/or identify the medical
item to the system for storage of monitored information as described
above.
Another exemplary thermal treatment system 500 with monitoring,
transmission printout and/or usage control capabilities is illustrated
in FIG. 20. The system is of the type disclosed in U.S. Pat. No.
6,371,121 (Faries, Jr. et al.). Specifically, system 500 includes
a cabinet or system housing with a top surface 502 supporting a
basin 504. System 500 is designed to be covered with a sterile drape
512 that envelopes the cabinet and basin surfaces, thereby creating
a sterile field for warming and/or cooling sterile fluids. System
500 is further equipped with a power on/off button 506, an optional
display 508 with input/output control buttons 510 and a temperature
controller to control system operation in accordance with a set
point temperature entered by a user and a temperature measured by
a temperature sensor as described above. The system includes a configuration
similar to that described above for system 100 and may further include
report unit 101 and/or usage control unit 1001 to generate, transmit
and/or print reports and/or control system usage as described above
for system 100.
Yet another exemplary warming/cooling system 600 for IV lines with
monitoring, transmission, printout and/or usage control capabilities
is illustrated in FIG. 21. The system is of the type disclosed in
U.S. Patent Application Publication No. 2003/0114795 (Faries, Jr.
et al.). Specifically, medical item warming/cooling system 600 includes
a system base 602 that houses a heating element and corresponding
temperature sensor (not shown). The base top surface receives a
cassette of IV tubing 606. The cassette may include any of the devices
or indicia (e.g., monitoring device, memory device, bar code, transponder,
ink cells, etc.) described above for solution bag 2 to monitor compliance
with prescribed requirements for the IV solution. Lid or cover 608
includes an additional heating element and closes upon the cassette
loaded within system base 602, thereby substantially encasing sterile
tubing 606. A first end 610 of sterile tubing 606 with connector
612 and a second end 614 of sterile tubing 606 with connector 616
protrude from medical item warming/cooling system 600 to connect
to an IV line. A controller 618 includes a display and control input/output
buttons to control operation of medical item warming/cooling system
600 in accordance with a set point temperature entered by a user
and a temperature measured by the temperature sensor as described
above. The system includes a configuration similar to that described
above for system 100 and may further include report unit 101 and/or
usage control unit 1001 to generate, transmit and/or print reports
and/or control system usage as described above for system 100.
A further temperature control system of the present invention for
thermally treating and/or monitoring medical solution containers
(e.g., bags or bottles containing saline or intravenous (IV) solutions,
antibiotics or other drugs, blood, etc.) or other medical items
(e.g., instruments, blankets, etc.) with direct measurement of medical
item temperature and display of medical item residence time within
the system is illustrated in FIGS. 22-24. Specifically, temperature
control system 700 includes a cabinet or system housing 704 with
substantially similar drawers 706a, 706b for enabling placement
and removal of medical items, such as intravenous solution bags,
within the system and a controller 722 for controlling heating of
the drawers to maintain the bags at the same or different desired
temperatures. Cabinet 704 is generally in the form of a rectangular
box and includes top and bottom walls 710, 712, side walls 714,
716 and front and rear walls 718, 720. The cabinet walls are each
substantially rectangular and collectively define a cabinet interior.
Further, side wall 716 typically includes a series of labels 724,
such as fuse warning labels and labels providing other information,
and a plurality of fuse holders 726 for receiving fuses of the system
control circuitry described below. The cabinet is typically constructed
of electro-galvanized steel (e.g., eighteen gauge) or other suitably
sturdy material, and may be of any size or shape.
Drawers 706a, 706b are generally disposed in vertical alignment
in front wall 718 toward side wall 714, while controller 722 is
disposed in front wall 718 adjacent drawer 706a and power switch
723 toward side wall 716. Controller 722 enables entry of a desired
or set point temperature associated with each drawer and controls
heating of intravenous solution bags residing within the drawers
based on the associated desired temperatures as described below.
Power switch 723 is generally disposed below controller 722 and
enables power to the controller for heating intravenous solution
bags disposed within the drawers. By way of example only, cabinet
704 includes two drawers, however, any quantity (e.g., at least
one) of drawers, power switches, controllers and control circuitry
may be utilized, while the cabinet components may be arranged in
any fashion.
Drawers 706a, 706b each include a front wall or door 728, a rear
wall 730, a bottom wall 732 and side walls 734, 736. The drawer
walls are each substantially rectangular and collectively define
a compartment or drawer interior having an open top portion for
enabling placement and removal of intravenous solution bags within
the drawers. The drawers may be of any size or shape, and the system
may include any combination of drawers of different or substantially
similar types.
Door 728 includes a handle 738 typically disposed toward the door
upper portion, whereby the handle may be implemented by any conventional
or other type of handle. Alternatively, the handle may be disposed
on the door at any suitable location. Door 728 generally enables
a corresponding drawer to pivot into and out of the cabinet as described
below, and is typically constructed of electro-galvanized steel
(e.g., sixteen gauge) or other suitably sturdy material. The door
further includes a substantially rectangular opening 740 covered
by a substantially transparent material 742, such as glass or plexiglass,
to serve as a window to enable viewing of the intravenous solution
bags and maintain heat within the cabinet. The door, opening and
transparent material may be of any size or shape. Divider walls
744, 746 are disposed within each drawer interior to partition that
interior into sub-compartments or bins 752a, 752b, 752c. In particular,
divider walls 744, 746 (FIG. 24) extend from rear wall 730 substantially
in parallel to, and include dimensions substantially the same as,
side walls 734, 736. The front and rear edges of dividers 744, 746
are bent at an angle of approximately ninety degrees relative to
the respective divider wall body portions, and extend transversely
toward side wall 734 to form ledges 748, 750, respectively. Similarly,
the front edges of side walls 734, 736 are bent at an angle of approximately
ninety degrees relative to the respective side wall body portions,
and extend transversely toward each other to form ledges 749, 751,
respectively. Further, the front edge of bottom wall 732 is bent
at an angle of approximately ninety degrees relative to the bottom
wall body portion, and extends upward toward a drawer upper portion
to form ledge 753. Ledges 750 enable the divider walls to interface
rear wall 730, while ledges 748 include a recess or gap to permit
the divider walls to engage and secure transparent material 742
within opening 740 of door 728. Moreover, ledges 748, 749, 751 and
753 enable the door to interface the drawer side, bottom and divider
walls. Each drawer sub-compartment is typically configured to accommodate
a single intravenous solution bag, and is defined by the drawer
rear, bottom, side and divider walls. Specifically, sub-compartment
752a is defined between side wall 734 and divider wall 744, sub-compartment
752b is defined between divider walls 744, 746 and sub-compartment
752c is defined between divider wall 746 and side wall 736. The
drawer side, rear, bottom and divider walls are typically constructed
of copper or other suitable heat conducting material to conduct
and evenly distribute heat to the intravenous solution bags disposed
within the drawer as described below.
A heating element or pad 754 is typically disposed on the underside
of each drawer bottom wall 732, whereby the heat applied by the
heating pad is conducted by the drawer bottom, side, rear and divider
walls to provide an even heat distribution to the intravenous solution
bags residing in the sub-compartments of that drawer. In other words,
each individual drawer sub-compartment includes bottom, side and
rear walls that conduct and directly transmit heat from the heating
pad to the intravenous solution bag contained in that sub-compartment,
thereby preventing other intravenous solution bags residing in the
cabinet from being affected by the applied heat. The application
of heat from the sub-compartment walls provides a relatively uniform
heat distribution and prevents the occurrence of certain intravenous
solution bags (e.g., bags disposed near the heat source) attaining
higher temperatures than the remaining bags (e.g., bags disposed
at other locations within the cabinet) as is typically present in
common single heat source systems. Alternatively, the heating pad
may be disposed on the side or rear walls of each drawer. The heating
pad is preferably configured to cover only a portion of a drawer
bottom wall, but may include any type of configuration (e.g., strips,
bars, segments, include various openings, etc.). A temperature sensor
756 is typically disposed on the underside of each drawer bottom
wall 732 generally within the confines of the corresponding heating
pad (e.g., the portion of the heating pad not covering the drawer
bottom wall). The temperature sensor is preferably implemented by
a conventional RTD temperature sensor and measures the temperature
of the bottom wall of the corresponding drawer. However, the temperature
sensor may be implemented by any conventional or other type of temperature
sensor, and may be disposed at any suitable location on or within
a drawer. The drawer may further include any type of sensors or
sensing devices (e.g., temperature sensors, presence sensors, weight
sensors, volume sensors, pressure sensors, flow sensors, fluid sensors,
fluid level sensors, etc.) to measure and provide any desired information.
The temperature measurement of sensor 756 is provided to the controller
for control of the corresponding heating pad as described below.
An exemplary heating pad of the type employed by temperature control
system 700 is illustrated in FIG. 25. Specifically, heating pad
754 is substantially rectangular and includes a substantially rectangular
opening 758. A connector 760 is disposed along a heating pad shorter
dimension edge to facilitate connections for the heating pad. The
heating pad is preferably implemented by a conventional etched foil
silicon rubber heater (e.g., forty-four watts, one-hundred twenty
VAC) having an extra layer of silicon rubber on the adhesive side.
The heating pad further includes a pressure sensitive adhesive for
attachment to a drawer bottom wall. Temperature sensor 756 is typically
disposed within opening 758 to measure the temperature of a corresponding
drawer bottom wall as described above. The heating pad may be of
any quantity (e.g., at least one), shape, or size, and may include
any configuration that covers the entirety or a portion of a corresponding
drawer bottom wall. In addition, the heating element or pad may
be implemented by any conventional or other type of heater or heating
element (e.g., heating coils) to heat the drawers.
Referring back to FIGS. 22-24, side walls 734, 736 of drawers 706a,
706b interface respective doors 728 via posts 762 to secure the
drawers to the doors. Each door 728 further includes a pivoting
mechanism having a pivot hinge (not shown) and a locking hinge 764
to enable a corresponding drawer to angle forward and pivot outward
from the cabinet interior into an open position. In particular,
locking hinge 764 includes a receptacle 766 disposed on a corresponding
door 728, a curved track or slide 768 and a pin or bolt disposed
within the cabinet interior (not shown). Receptacle 766 is disposed
toward an intermediate portion of the corresponding door and extends
from that door interior surface toward the cabinet interior. The
receptacle includes an opening through which a pin or bolt 770 is
inserted to connect a proximal end of slide 768 to the corresponding
door.
Curved slide 768 typically extends from receptacle 766 of the corresponding
door into the cabinet interior and curves toward cabinet bottom
wall 712. The slide includes an opening 772 extending along the
slide from the receptacle into the cabinet interior, whereby an
associated cabinet interior bolt is disposed within and through
the opening to enable the corresponding drawer to pivot out of and
into the cabinet interior to open and closed positions, respectively.
The distal end of the slide, in combination with the associated
cabinet interior bolt, serves as a stop to limit pivoting or the
forward angle of the corresponding drawer. Locking hinge 764 may
be disposed adjacent either side wall 734, 736 of the corresponding
drawer, or a door may include dual pivoting mechanisms, whereby
a mechanism is disposed adjacent each corresponding drawer side
wall. An operator typically grasps handle 738 of a corresponding
door and applies force to draw that handle forward, thereby forcing
slide 768 of that door forward, while the associated cabinet interior
bolt traverses corresponding slide opening 772. When sufficient
force is applied to the handle, the distal end of the corresponding
slide opening is caused to engage the associated cabinet interior
bolt to prevent further pivoting of a corresponding drawer. Conversely,
force may be applied to the handle to facilitate pivoting of the
corresponding drawer toward the cabinet to a closed position, whereby
the corresponding slide is forced into the cabinet interior, while
the associated cabinet interior bolt traverses corresponding slide
opening 772.
The system may further include temperature sensing devices 125
(FIG. 23), preferably in the form of temperature sensing strips,
and timing devices or timers 702 to measure and display the residence
time of a medical item within an associated sub-compartment. Temperature
sensing devices 125 are disposed within respective sub-compartments
752a, 752b and 752c of each drawer proximate window or material
742. The medical items within the sub-compartments are in thermal
relation with the corresponding temperature sensing devices to enable
the devices to measure and display the item temperatures as described
below. Material 742 is substantially transparent to enable viewing
of the temperature indications through the window.
Temperature sensing devices 125 are each preferably in the form
of a substantially rectangular strip and include a temperature scale
122 arranged in a vertical fashion to measure and display a solution
temperature in a particular temperature range. The temperature scale
typically includes numerical indicators 130 arranged in sequential
order, whereby each indicator represents a ten degree temperature
interval (e.g., 70.degree. F., 80.degree. F., 90.degree. F., 100.degree.
F., 110.degree. F. as viewed in FIG. 23).
The temperature sensing strip preferably includes a series of temperature
sensitive substances that provides visual color changes to or illuminates
the temperature scale indicators to display a solution temperature.
In particular, each temperature scale indicator 130 is typically
associated with a temperature sensitive substance having a particular
temperature threshold range corresponding to that indicator. When
the solution temperature is within the threshold temperature range
of a substance, that substance changes color or illuminates the
associated temperature scale indicator to display the solution temperature.
For example, if the solution has a temperature of 90.degree. F.,
then only the temperature scale indicator representing a ninety
degree temperature changes color or becomes illuminated to visually
display the solution temperature. The temperature thresholds may
be adjusted in any manner to enable a single or a plurality of temperature
scale indicators to be illuminated in response to a solution temperature
residing between successive temperature scale indicators. Further,
the temperature thresholds may be set to illuminate a successive
indicator (e.g., a 90.degree. F. indicator may be set to illuminate
at any temperature between 90.degree. F.-100.degree. F.).
The temperature sensing strip is preferably implemented by a conventional
temperature strip having common temperature sensitive substances
(e.g., a liquid crystal composition), such as the types of substances
disclosed in U.S. Pat. No. 3,651,695 (Brown), U.S. Pat. No. 3,861,213
(Parker), U.S. Pat. No. 3,864,976 (Parker), U.S. Pat. No. 4,859,360
(Suzuki et al) and U.S. Pat. No. 5,806,528 (Magliochetti). The disclosures
of the foregoing patents are incorporated herein by reference in
their entireties. By way of example only, each temperature sensing
device 125 includes a configuration where temperature scale 122
has duplicate temperature scale indicators 130 for each temperature
level with corresponding temperature sensitive substances disposed
between the duplicate scale indicators and displays temperatures
in the range of 70.degree. F.-110.degree. F., whereby the duplicate
temperature scale indicators 130 for each level represent a successive
ten degree temperature interval (e.g., 70.degree. F., 80.degree.
F., 90.degree. F., 100.degree. F. and 110.degree. F). However, the
temperature sensing device may be of any size or shape, while the
temperature scale may include any quantity or types of indicators
for representing any sized intervals in any desired temperature
range.
Timers 702 are each associated with a corresponding drawer sub-compartment
and are disposed on front wall 718 adjacent the corresponding drawer.
Timers 702 each include a display 140 to indicate the amount of
time a medical item has resided within a corresponding sub-compartment.
In other words, the timer measures and indicates the amount of time
a medical item has been warmed by the system. The timer may be implemented
by any conventional or other timing or time measuring devices and
may include any conventional or other type of display (e.g., LED,
LCD, etc.).
Timers 702 are each controlled by a corresponding timer switch
150 (FIG. 22) to measure and indicate residence time in accordance
with placement of a medical item within that sub-compartment. Timer
switch 150 is disposed within each sub-compartment on drawer back
wall 730. Basically, when a medical item is placed into a sub-compartment
and against a timer switch, the timer switch enters a closed state
and enables a corresponding timer 702 to begin measuring elapsed
time. The elapsed time is displayed on display 140 of that timer,
preferably in the format of hours, minutes and seconds. However,
the elapsed time may be measured and/or displayed in any desired
format or fashion (e.g., days, hours, minutes, seconds, etc.). When
the medical item is removed from the sub-compartment, the timer
switch enters an open state, thereby causing the timer to reset
as described below. The timer display notifies medical personnel
of the residence time of a medical item within the sub-compartment.
In other words, the timer informs medical personnel of the amount
of time a medical item has been warmed. Since medical items typically
have limits with respect to warming time, medical personnel may
remove the warmed medical item prior to excessive heating of the
medical item and reduction in effectiveness.
Controller 722 typically includes a display 774 (e.g., LED or LCD)
and a plurality of input devices or buttons 776 for enabling entry
of a desired or set point temperature for each drawer. Input devices
776 are manipulated to enable entry of the desired temperatures,
while display 774 may alternatively indicate the actual temperature
for each drawer measured by a corresponding temperature sensor 756
(FIG. 24) or the desired or set point temperature for each drawer
entered by the operator. Display 774 typically displays the measured
drawer temperatures, and may be directed, via the input devices,
to display the set point temperatures.
The controller essentially implements a feedback control loop to
control heating of the drawers. Specifically, controller 722 receives
a temperature signal from each temperature sensor 756 indicating
the temperature of the corresponding drawer bottom wall. In response
to the measured temperature of a corresponding drawer bottom wall
being equal to or exceeding the desired temperature associated with
that drawer, the controller disables power to the associated heating
element via a solid state relay described below. Conversely, when
the measured temperature of the corresponding drawer bottom wall
is below the desired temperature associated with that drawer, the
controller enables power to the associated heating element via the
solid state relay. The controller may be implemented by any conventional
or other controller, processor or circuitry utilizing any control
algorithm (e.g., fuzzy logic, PID, etc.) to control the heating
elements.
An exemplary control circuit of the temperature control system
is illustrated in FIG. 26. Specifically, system control circuit
777 includes control circuits 778a, 778b to control heating of corresponding
drawers 706a, 706b, respectively. The control circuits are coupled
to controller 722 and power switch 723 to enable power to the circuits
and control the heaters. A conductor 780 typically supplies a positive
potential, while a conductor 782 provides a negative or reference
potential. A conductor 196 is connected to ground. A fuse 786 is
connected in series with conductor 780 and the power switch, while
a fuse 790 is connected between the controller, power switch and
solid state relays 788 of control circuits 778a, 778b to prevent
surges from damaging the circuitry. Power switch 723 is connected
to conductors 780, 782. The power switch is further connected to
controller 722 and heaters 754 and solid state relays 788 of control
circuits 778a, 778b to enable power to those components.
Control circuit 778a includes temperature sensor 756, conventional
solid state relay 788, a conventional temperature cut out switch
792 and heating element or pad 754. Controller 722 receives power
from power switch 723 and is further connected to temperature sensor
756 and solid state relay 788 of control circuit 778a. The temperature
sensor measures a corresponding drawer bottom wall temperature and
transmits a signal to controller 722 indicating that temperature.
The controller controls the solid state relay to enable or disable
power to the heating pad based on the measured temperature as described
above. The solid state relay is connected to the heating pad, while
temperature cut-out switch 792 is connected between the relay and
heating pad to disable the heating pad in response to detecting
a heating pad temperature in excess of a predetermined threshold.
Control circuit 778a further includes timers 702, reset relays
170, timer switches 150, a connection terminal 190 and a power source
160. The power source is connected to the solid state relay and
connection terminal, while the timer switches 150 are each connected
between the connection terminal and a corresponding reset relay
170 to facilitate control of the corresponding sub-compartment timer
in accordance with the presence of a medical solution container
within that sub-compartment. Each reset relay is connected to a
corresponding timer and timer switch and may be implemented by any
conventional or other relay type device. Basically, the timer switch
enables a corresponding reset relay to control a corresponding timer.
When a medical solution container is present in a sub-compartment,
the timer switch is in a closed state as described above. Accordingly,
the connection, via the connection terminal, between the power source
and reset relay is enabled. The reset relay controls the reset of
a corresponding timer 702. The timer basically resets when the reset
line is low or grounded. Thus, when a medical item is removed from
a sub-compartment and the corresponding timer switch enters an open
state, the corresponding reset relay does not receive power from
the power source and provides a low signal to the timer reset line,
thereby facilitating a timer reset. When the timer switch enters
a closed state due to the presence of a medical solution container
in the sub-compartment, the corresponding reset relay receives power
signals from the power source, thereby providing a high signal to
the timer reset line enabling the timer to operate. Control circuit
778a may be implemented by any conventional circuitry components
performing the above-described functions. Control circuit 778b is
connected in parallel with and is substantially similar to control
circuit 778a described above to control heating of drawer 706b.
System 700 includes a configuration similar to that described above
for system 100 and may include report unit 101 and/or usage control
unit 1001 coupled to controller 722 to generate, transmit and/or
print reports and/or control system usage as described above for
system 100. The drawer sub-compartments may each further include
an interface 20 in the form of a wireless transmitter/receiver (e.g.,
RF, infrared, etc.), bar code scanner or connector or port to communicate
with the medical item or identify the medical item to system 700
for storage of monitored information as described above.
Operation of the temperature control system is described with reference
to FIGS. 22-26. Initially, an operator selects intravenous solution
bags (e.g., containing intravenous solution) or other medical items
for heating within the cabinet and determines appropriate temperatures
for the items. The items may include the devices described above
for solution bag 2. The operator subsequently selects a drawer 706a,
706b and enables power switch 723, whereby the operator grasps and
applies force to handle 738 of the selected drawer to pivot that
drawer outward from the cabinet interior to an open position. Intravenous
solution bags are disposed within any quantity (e.g., at least one)
or combination of corresponding drawer sub-compartments 752a, 752b,
752c such that any one sub-compartment contains a single intravenous
solution bag. In response to placement of a container in the sub-compartment,
the container engages and causes closure of a corresponding timer
switch 150. The switch closure provides a connection between power
source 160 and corresponding reset relay 170 that initiates the
timer. The selected drawer is subsequently pivoted into the cabinet
interior to a closed position, while the timer continuously displays
the elapsed time to medical personnel on timer display 140 as described
above. The desired temperature for each utilized drawer is entered
into controller 722 via input devices or buttons 776. The controller
receives signals from corresponding temperature sensors 756 (FIG.
24) and determines appropriate controls for solid state relays 788
(FIG. 26) to enable or disable power to heating pads 754 of the
utilized drawers as described above. The heating pads apply heat
to corresponding drawer bottom walls, whereby the drawer rear, side
and divider walls conduct heat from the bottom wall to evenly distribute
heat to the intravenous solution bags residing within the corresponding
drawer sub-compartments as described above.
Controller 722 displays on display 774 each drawer bottom wall
temperature measured by a corresponding temperature sensor 756,
and may be directed to alternatively display the desired temperature
entered for each drawer based on manipulation of input devices 776.
Temperature sensing devices 125 measure and display the medical
item temperature during heating as described above. Further, the
intravenous solution bags may be viewed through transparent material
742 during heating. Moreover, system 700 may collect and provide
information or reports (e.g., FIGS. 12A-12I) and/or control system
usage as described above for system 100, where the reports or information
can be transmitted to an internal printer 110, display 774 or to
a local or remote external device (e.g., printer, display, database,
medical item, etc.) as described above.
When the intravenous solution bags have attained the desired temperature,
the selected drawer is pivoted to an open position as described
above, whereby the heated bags are removed from sub-compartments
of the selected drawer for use. The corresponding timer switches
subsequently enter an open state, thereby resetting the corresponding
timers and displays. Additional intravenous solution bags may replace
the removed heated bags within those sub-compartments for heating
by the system. It is to be understood that either or both of the
drawers may be used and independently controlled in substantially
the same manner described above to maintain items at the same or
different desired temperatures. Further, any quantity of intravenous
solution bags or items may be disposed within the sub-compartments
and drawers for heating by the cabinet.
Yet another temperature control system of the present invention
for thermally treating and/or monitoring medical solution containers
(e.g., bags or bottles containing saline or intravenous (IV) solutions,
antibiotics or other drugs, blood, etc.) or other medical items
(e.g., instruments, blankets, etc.) with direct measurement of medical
item temperature and display of medical item residence time within
the system is illustrated in FIGS. 27A-27C. Initially, the system
is of the type disclosed in aforementioned U.S. patent application
Ser. No. 10/076,112. Specifically, system 800 includes a housing
802 including a heating compartment 804 and a storage compartment
806 disposed above the heating compartment. The heating compartment
includes a front wall 810, a rear wall 812, side walls 814, 816,
a bottom wall 820 and a front panel 840 that collectively define
the heating compartment interior. A door 830 is disposed on the
housing to cover a heating compartment open portion that facilitates
placement and removal of items within the heating compartment as
described below. Front and rear walls 810, 812 are substantially
rectangular and are attached to and extend between side walls 814,
816. Front wall 810 has a height substantially less than that of
rear wall 812. Bottom wall 820 is substantially rectangular and
is attached to the bottom edges of the heating compartment front,
rear and side walls. Side walls 814, 816 are generally rectangular
with respective truncated upper front corner sections. The truncated
section of side wall 814 includes an angled edge that extends from
front wall 810 toward the storage compartment. The truncated section
of side wall 816 includes a similarly angled edge.
Front panel 840 includes a control panel 841 and a projection 853.
The control panel is substantially rectangular and is attached to
front wall 810 and the angled edge of side wall 814. The control
panel has a transverse dimension substantially less than the distance
between side walls 814, 816 and is oriented at an angle toward rear
wall 812 similar to that of the angled edge of side wall 814. Projection
853 is substantially rectangular and is attached to front wall 810,
a control panel lower section and side wall 816. The projection
extends from the front wall toward the storage compartment for a
slight distance and is oriented at an angle similar to that of control
panel 841. The open area between control panel 841, side wall 816
and projection 853 defines the heating compartment open portion.
Storage compartment 806 is disposed above heating compartment 804
and includes a top wall 818, side walls 824, 826 and front and rear
walls 828, 832 that collectively define the storage compartment
interior. Front and rear walls 828, 832 are substantially rectangular
and are attached to and extend between side walls 824, 826. Front
wall 828 extends from the upper edges of door 830 and control panel
841, while rear wall 832 extends from and is integral with heating
compartment rear wall 812. Side walls 824, 826 are substantially
rectangular and are attached to and extend between respective side
edges of front and rear walls 828, 832. The side walls respectively
extend from and are integral with respective heating compartment
side walls 814, 816.
Top wall 818 is substantially rectangular and is attached to the
upper edges of the storage compartment front, rear and side walls.
Top wall 818 further provides access to the storage compartment
and is typically pivotally connected to rear wall 832. The top wall
opens upward from the storage compartment to enable placement and
removal of medical solution containers within the system. Door 830
is typically pivotally connected to the lower portion of front wall
828 and opens upward from the heating compartment in order to provide
access to the heating compartment for placement and removal of medical
solution containers within that compartment. Top wall 818 and door
830 may both be partially or completely transparent to allow viewing
of the storage and heating compartment interiors, respectively.
In addition, top wall 818 and/or door 830 may include any type of
handle or latching mechanism to facilitate access to the system
interior. The storage compartment basically houses additional medical
solution containers to enable the system to accommodate and heat
plural containers as described below.
Control panel 841 includes a power switch 843 and a controller
845 to indicate solution temperature and control operation of the
system as described below. Controller 845 includes a display 847
(e.g., LED or LCD) and a plurality of input devices or buttons 849.
The input devices are manipulable by a user to enable entry of a
desired or set point temperature for a medical solution container
placed within the housing compartment. Display 847 typically displays
the measured temperature of the solution and may further be directed,
via input devices 849, to display the desired or set point temperature.
The controller receives a desired temperature from a user and controls
heating of a medical solution to attain that temperature as described
below. The heating compartment houses a heating assembly 835 to
uniformly apply heat to a medical solution. The heating assembly
includes heating plate 850, heater 858 (FIG. 29), temperature sensor
872 and limit switch 865. The heating plate includes bottom wall
852 and side walls 854 extending at an angle from the bottom wall
longer dimensioned side edges toward the interior surfaces of the
heating compartment front and rear walls to form a generally `U`-shaped
heating plate configuration. Heater 858 is disposed on the bottom
surface of the heating plate bottom wall. This arrangement facilitates
rapid heating of a medical item which is especially advantageous
during employment of the system in time critical situations, such
as in an operating room. For example, the system may heat items
to a desired temperature in the approximate range of 80.degree.
F. to 150.degree. F. within a short time interval, generally within
one hour (e.g., the particular time interval depends on various
factors, such as initial item temperature, room temperature, selected
desired temperature, etc.).
Limit switch 865 controls heater 858 in response to placement and
removal of medical solution containers on the heating plate. Specifically,
the limit switch is typically implemented in the form of a pressure
type switch that enables or disables the heater in response to detection
of pressure (e.g., the weight of a container) applied to a portion
of the heating plate. However, the limit switch may alternatively
be configured in any manner suitable for operation of the system.
The limit switch includes a housing 862 (FIG. 27C) and an arm 875
(FIG. 27B). The limit switch housing is disposed beneath the heating
plate bottom wall and includes a post or support member 874 extending
from the housing top surface toward the heating plate. Arm 875 is
attached in a cantilevered manner to the support member. Temperature
sensors 872, 886 are mounted on arm 875 toward the arm distal end
with wiring 871, 873 extending from the respective sensors to controller
845. Temperature sensor 886 basically measures excessive temperatures
and serves as a cut-off switch as described below. The arm extends
from the support member along the underside of the heating plate
bottom wall to align sensor 872 with an opening (not shown) defined
in the heating plate bottom wall. The bottom wall opening provides
temperature sensor 872 with access to a medical solution container
placed on the heating plate. The limit switch arm is constructed
of a resilient material that biases the arm toward the heating plate
and enables the arm to move between that plate and the limit switch
housing. The arm bias further forces the temperature sensor against
a medical solution container placed on the heating plate, thereby
facilitating an accurate temperature measurement. A contact member
876 is disposed on the limit switch housing coincident a distal
portion of the limit switch arm and extends into the limit switch
housing via an opening (not shown) defined in that housing. The
contact member is typically directly attached to or resiliently
biased toward the limit switch arm to enable movement of the contact
member into or out of the limit switch housing in response to flexing
of the limit switch arm.
The contact member is configured to actuate switch circuitry 877
disposed within the limit switch housing. In particular, the limit
switch arm flexes toward the limit switch housing in response to
pressure applied to the arm from a medical solution container placed
on the heating plate. The contact member is subsequently urged into
the housing and interfaces the switch circuitry. This motion results
in actuation of the switch circuitry and effectively closes switch
865, thereby enabling heater 858. When a container is removed from
the heating plate, arm 875 is biased toward the heating plate bottom
wall with the contact member being withdrawn from the switch circuitry.
This motion effectively results in disablement of the switch circuitry
and effectively opens switch 865, thereby disabling the heater.
The limit switch arm may further include a cut-out switch and/or
additional temperature sensor 886 to facilitate disablement of the
heater in response to excessive temperatures.
System 800 further includes a timer 860 (FIG. 27A) to measure and
display residence time of a medical item on heating plate 850. Timer
860 is disposed on front wall 828 toward an upper front wall corner
adjacent side wall 824. Timer 860 includes a display 862 to indicate
the amount of time a medical item has resided on the heating plate.
In other words, the timer measures and indicates the amount of time
a medical item has been warmed by the system. The timer may be implemented
by any conventional or other timing or time measuring devices and
may include any conventional or other type of display (e.g., LED,
LCD, etc.). In addition, front wall 828 may further include a substantially
rectangular window 864 disposed adjacent timer 860 to enable medical
personnel to view and ascertain the quantity of medical items within
storage compartment 806. The window may be of any shape or size,
may be disposed at any suitable locations and may be constructed
of any suitably transparent materials (e.g., glass, plastics, etc.).
System 800 may be mounted on a stand 890 to facilitate transport
of the system to various sites (e.g., operating room, patient room,
etc.). The stand includes a post 892 and a base 893. The base is
basically configured in a star type configuration and includes a
hub 895 and a plurality of legs 894. The hub is generally cylindrical
with legs 894 extending transversely therefrom. The legs are in
the form of generally rectangular rods and each leg includes a caster
or roller 896 to enable transport of the system. Post 892 is substantially
cylindrical and extends upward from hub 895. The post engages bottom
wall 820 of system 800 to connect the system to the stand. The post
and/or system bottom wall may include any conventional or other
fasteners to couple the system to the stand. Alternatively, system
800 may be mounted to any support structures (e.g., wall, pole,
door, stands, etc.) via any conventional fastening mechanisms (e.g.,
brackets, hooks, etc.). The stand may be utilized with any of the
thermal treatment systems described herein.
Timer 860 is controlled by limit switch 865 to measure and indicate
residence time in accordance with placement of a medical item on
heating plate 850. Basically, when a medical item (FIG. 27C) is
urged by gravitational forces or manually manipulated onto the heating
plate and limit switch as described above, the limit switch enters
a closed state and enables timer 865 to begin measuring elapsed
time. The elapsed time is displayed on timer display 862, preferably
in the format of hours, minutes and seconds. However, the elapsed
time may be measured and/or displayed in any desired format or fashion
(e.g., days, hours, minutes, seconds, etc.). The limit switch further
actuates a time delay relay that delays operation of the heater
for a predetermined time interval. This delay enables the temperature
of temperature sensor 872 to approach the medical item temperature
to provide enhanced temperature measurements as described below.
When the medical item is removed from the heating plate, the limit
switch enters an open state, thereby causing the timer to reset
via a reset relay as described below. The timer display notifies
medical personnel of the residence time of a medical item on the
heating plate. In other words, the timer informs medical personnel
of the amount of time a medical item has been warmed. Since medical
items typically have limits with respect to warming time, medical
personnel may remove the warmed medical item prior to excessive
heating of the medical item and reduction in effectiveness. Upon
removal of a medical item from the heating plate, the next medical
item within the storage compartment is gravitationally urged or
manually manipulated onto the heating plate and the limit switch
enters a closed state to start the timer and time delay as described
above.
The configuration of heating plate 850 enables uniformed heating
of the medical item as described above. However, the uniform heating
may be adversely affected when a medical item is disoriented or
improperly positioned on the heating plate. Accordingly, system
800 may further include guides 870, 880 (FIG. 27A) to orient and
ensure proper placement of a medical item on the heating plate.
In particular, guide 870 is typically inserted within the system,
via top wall 818, and disposed adjacent side walls 814 and 824.
Similarly, guide 880 is disposed in the system via the top wall
and disposed toward side walls 816 and 826. The guides distal ends
each rest at respective opposing ends of heating plate 850 and extend
from the heating plate through heating and storage compartments
804, 806 to top wall 818. The guides basically form a channel therebetween
having dimensions slightly larger than the corresponding medical
item. The medical item is inserted within the storage compartment
in the channel, where the medical item orientation is maintained
by the guides for proper placement on the heating plate.
Referring to FIGS. 28A-28D, each guide is generally `L`-shaped
and includes a leg 882 and a foot 884. The leg is generally rectangular
and has a height substantially similar to the distance between the
heating plate and top wall 818. The depth of the leg is slightly
less than the distance between the storage compartment front and
rear walls to enable insertion of the guide into the system. Foot
884 is generally rectangular and connected at an obtuse angle to
a distal end of leg 882. The foot has a truncated corner on its
bottom edge to provide a configuration to accommodate the contour
of the heating plate. The guides are preferably constructed of foam
material, but may be constructed of any suitable materials.
The dimensions of the guides may vary in accordance with the dimensions
of the medical item and system housing employed. For example, the
height of leg 882 may vary to accommodate different sized system
housings, while the width of the guides may vary to accommodate
varying sized medical items. By way of example only, the guides
of FIGS. 28A-28B may accommodate liter solution bags and include
thinner dimensions than those of the guides in FIGS. 28C-28D which
may accommodate half liter solution bags. The thinner dimensions
of the guides in FIGS. 28A-28B enable a greater distance or larger
dimensioned channel to reside between the guides to accommodate
larger solution bags. Conversely, the thicker dimensions of the
guides in FIG. 28C-28D enable a lesser distance or smaller dimensioned
channel to reside between the guides to accommodate smaller solution
bags. Similarly, the guides of FIGS. 28A and 28C include greater
heights than those of the guides of FIGS. 28B and 28D in order to
accommodate a taller housing. The guides are inserted into system
800 each toward a respective side wall, where each foot 884 resides
on and contours the heating plate with a corresponding leg 882 extending
therefrom toward the housing top wall. The distance between the
guides provides a channel to maintain proper orientation of medical
items within the system as described above.
An exemplary control circuit for system 800 is illustrated in FIG.
29. Specifically, control circuit 885 includes power conductors
801, 803, ground 807, power switch 843, controller 845, solid state
relay 805, limit switch 865, heater 858 and temperature sensors
872, 886, each as described above. The circuitry further includes
timer 860, a time delay relay 808, a reset relay 811 and a power
source 809. Power conductors 801, 803 each include a respective
fuse 815, 817 (e.g., a conventional 2 amp fuse) that is arranged
in series with power switch 843 to prevent power surges from damaging
the switch and circuitry. Power switch 843 controls power to the
circuitry and is connected to the controller, solid state relay,
power source and heater. The power switch may include a light to
illuminate the switch. Controller 845 is further connected to solid
state relay 805 and temperature sensors 872, 886. The controller
controls power applied to the heater via relay 805 in accordance
with a comparison of a temperature measured by temperature sensor
872 and a desired temperature entered into the controller by a user.
In particular, controller 845 receives temperature signals from
temperature sensor 872 indicating the temperature of a medical solution
container in contact with the sensor (i.e., the container disposed
on the heating plate surface). In response to the temperature measured
by temperature sensor 872 being equal to or exceeding a desired
temperature entered by a user, the controller disables power to
the heater via solid state relay 805. Conversely, when the temperature
measured by temperature sensor 872 is below the desired temperature,
the controller enables power to the heater via the solid state relay.
Limit switch 865 is connected between power source 809 and reset
relay 811 and facilitates control of the heater and timer in accordance
with the presence of a medical solution container within the system.
The power source is further connected to timer 860, while time delay
relay 808 is connected to reset relay 811, controller 845 and solid
state relay 805. The reset and time delay relays may be implemented
by any conventional or other relay type devices. Basically, the
limit switch enables the time delay and reset relays to control
the timer and power to the heater. When a medical solution container
is present on the heating plate, the limit switch is in a closed
state as described above. Accordingly, the connection between the
power source and reset relay is enabled. The reset relay controls
the reset of timer 860. The timer basically resets when the reset
line is low or grounded. Thus, when a medical item is removed from
the heating plate and the limit switch enters an open state, the
reset relay does not receive power from the power source and provides
a low signal to the timer reset line, thereby facilitating a timer
reset. When the limit switch enters a closed state due to the presence
of a new medical solution container on the heating plate, the reset
relay receives power signals from the power source, thereby providing
a high signal to the timer reset line enabling the timer to operate.
The reset relay further energizes the time delay relay which prevents
solid state relay 805 from enabling the heater for a predetermined
time interval. Preferably, the delay time interval is approximately
7.5 minutes, however, the time interval may be set to any desired
interval. The time delay enables the temperature of temperature
sensor 872 to approach the temperature of a new medical item received
on the heating plate to enhance temperature measurement. Basically,
the temperature of the temperature sensor is elevated due to contact
with a warmed medical item. When the warmed medical item is removed
from the system, the temperature sensor maintains the elevated temperature
for a short interval. Thus, the temperature sensor in this state
may provide elevated temperature readings relative to the actual
temperature of a new unwarmed medical item placed on the heating
plate. The time delay enables the temperature sensor to cool and
provide accurate temperature measurements. Once the time delay interval
has expired, time delay relay 808 enables the solid state relay
to control the heater in accordance with control signals from the
controller as described above.
When a medical solution container is removed or absent from the
heating plate, the limit switch is in an open state and the connection
between the reset relay and power source is disabled. The reset
relay does not receive power and provides a low signal on the reset
line of timer 860 to reset the timer. Similarly, the time delay
relay is without power and cannot energize solid state relay 805
to enable the heater. Thus, when the switch is in an open state
indicating no medical item on the heating plate, the timer is reset
and the heater is disabled.
Temperature sensor 886 is connected to the controller to facilitate
disablement of the heater in response to detecting a temperature
in excess of a predetermined threshold as described above. Basically,
temperature sensor 886 provides a temperature indication of the
solution container, heater and/or heating plate to controller 845.
The controller disables power to the heater via relay 805 in response
to the measured temperature exceeding a predetermined threshold
as described above. Control circuit 885 may alternatively be implemented
by any conventional circuitry components performing the above described
functions, and may utilize a cut-off switch in place of temperature
sensor 886 to disable the heater in response to excessive temperatures
as described above.
System 800 includes a configuration similar to that described above
for system 100 and may include report unit 101 and/or usage control
unit 1001 coupled to controller 845 to generate, transmit and/or
print reports and/or control system usage as described above for
system 100. Heating compartment 804 may further include an interface
20 in the form of a wireless transmitter/receiver (e.g., RF, infrared,
etc.), bar code scanner or connector or port to communicate with
the medical item or identify the medical item to system 800 for
storage of monitored information as described above.
Operation of system 800 is described with reference to FIGS. 27A,
27C and 29. Specifically, a user selects one or more medical solutions
(e.g., bags or bottles containing saline or IV solutions, antibiotics
or other drugs, blood, etc.) for heating by the system and determines
the appropriate temperature for the solution. The solution bags
may include the devices described above for solution bag 2. The
system may be mounted on stand 890 and transported to a desired
site. The user subsequently activates power switch 843 and pivots
top wall 818 to an open state. The user may insert appropriately
dimensioned guides 870, 880 into the system in order to properly
orient the medical items on the heating plate as described above.
The selected solution containers are placed into the system in stack
relation with an initial container disposed on plate 850 as described
above.
Top wall 818 is subsequently pivoted to a closed state and a desired
temperature for the selected solutions is entered into controller
843 via controller input devices or buttons 849. The medical solutions
within the storage compartment may be viewed through window 864
as described above. In response to placement of a container on the
heating plate bottom wall, the container engages temperature sensor
872 and causes closure of limit switch 865. The switch closure provides
a connection between power source 809 and reset relay 811 that initiates
the timer and energizes time delay relay 808. The time delay relay
disables the heater for the predetermined time interval as described
above. Once the time delay interval has expired, solid state relay
805 is enabled and controlled by the controller in accordance with
signals from temperature sensor 872 to enable or disable power to
heater 858 as described above. Timer 860 continuously displays the
elapsed time to medical personnel on timer display 862 as described
above. The heater applies heat to the heating plate bottom wall,
while heating plate side walls 854 conduct heat from bottom wall
852 to evenly distribute heat to the initial container. A cut-out
switch and/or temperature sensor 886 may be employed to facilitate
disablement of the heater in response to excessive heater, heating
plate and/or solution temperatures as described above.
Controller 845 displays the temperature of the container as measured
by temperature sensor 872, and may alternatively display the desired
or set point 11 temperature entered by the user. Moreover, system
800 may collect and provide information or reports (e.g., FIGS.
12A-12I) and/or control system usage as described above for system
100, where the reports or information can be transmitted to internal
printer 110, controller display 847 and/or to a local or remote
external device (e.g., printer, display, database, medical item,
etc.) as described above.
In response to attaining the desired temperature, the initial container
is removed from the heating plate via door 830. The limit switch
subsequently enters an open state, thereby disabling the connection
between the power source and the reset relay. The reset relay provides
a low signal to the timer, thereby resetting the timer and display.
A successive container is urged by gravitational forces and/or manually
manipulated into position on the heating plate bottom wall. The
limit switch enters a closed state and initiates operation of the
timer and time delay to repeat the process for this container. The
above process may be repeated for subsequent containers stored in
the system. Once the last container is removed, the limit switch
disables the heater until another container is placed on the heating
plate as described above.
Still another temperature control system of the present invention
for thermally treating and/or monitoring medical solution containers
(e.g., bags or bottles containing saline or intravenous (IV) solutions,
antibiotics or other drugs, blood, etc.) or other medical items
(e.g., instruments, blankets, etc.) with direct measurement of medical
item temperature and display of medical item residence time within
the system is illustrated in FIG. 30. Specifically, temperature
control system 900 includes a cabinet or system housing 904 with
a series of heating trays 908. Cabinet 904 is generally in the form
of a rectangular box and includes top and bottom walls 910, 912,
side walls 914, 916, a front door 928, a front panel 918 disposed
above the door, a front wall 929 and a rear wall 920. The cabinet
door, front panel and top, bottom and front walls are each substantially
rectangular, while the side walls are generally rectangular with
a truncated upper front corner portion. Top wall 910 extends from
rear wall 920 for a distance less than that between the rear wall
and front door. Front panel 918 extends from the front door upper
edge to the front edge of top wall 910 and is tilted at an angle.
The side edges of the tilted front panel follow along the truncated
upper front corners of side walls 914, 916. Front wall 929 is disposed
beneath front door 928 and extends to bottom wall 912. The walls,
panels and door collectively define a cabinet interior.
Trays 908 are disposed within the cabinet interior and may be mounted
therein via any conventional or other mounting devices (e.g., rails,
ledges, brackets, etc.). Each tray is preferably mounted in the
system interior at a downward angle toward rear wall 920 and includes
a plurality of heating assemblies 905, each with a heating plate
850 for receiving and heating a medical item to a desired temperature
as described above. Heating assemblies 905 are substantially similar
to heating assembly 835 described above for FIG. 27A, except that
heating plate bottom wall 852 has a curved or arcuate configuration.
The heating plate bottom wall side edges are attached to heating
plate side walls 854 to form a curved or generally `U`-shaped heating
plate configuration as described above. By way of example only,
system 900 includes four heating trays 908 with each tray including
four heating assemblies 905, thereby enabling heating of a maximum
of sixteen medical items at one time. However, the system may include
any quantity of trays with each tray including any quantity of heating
assemblies with any sized heating plates to accommodate various
sized medical solution containers (e.g., one liter, three liter,
etc.) or other medical items. A tray divider or partition 922 is
typically disposed between adjacent assembly heating plates on each
tray. However, adjacent heating plates may be placed proximate each
other without a divider, or the heating plates may be constructed
of or molded within a continuous sheet of conductive material and
utilized with the heating assemblies in substantially the same manner
described above.
Door 928 includes a handle (not shown) typically disposed toward
an intermediate section side edge. The handle may be implemented
by any conventional or other type of handle. Alternatively, the
handle may be disposed on the door at any suitable location. Door
928 generally pivots toward and away from the cabinet, and is preferably
constructed of electro-galvanized steel or other suitably sturdy
material with an opening covered by a substantially transparent
material, such as glass or plexiglass, to serve as a window to enable
viewing of the medical items and maintain heat within the cabinet.
Alternatively, the door may be constructed of a transparent material
(e.g., glass, plastic, etc.). The door, opening and transparent
material may be of any size or shape.
Rollers or casters 919 are attached to the cabinet bottom wall
with each caster disposed toward a corresponding cabinet bottom
wall corner to enable the system to be transportable. The casters
or rollers may be of any quantity, may be implemented by any conventional
or other types of rollers or wheel-type structures, and may be disposed
at any locations on the cabinet. Further, the cabinet may be constructed
of electro-galvanized steel or other suitably sturdy material, and
may be of any size or shape.
Trays 908 are generally disposed in vertical alignment within the
cabinet interior. The trays may be of any shape or size and may
be constructed of any suitable materials. The system and trays may
be configured to accommodate various sized medical items. By way
of example only, the system is configured to accommodate liter medical
solution bags. The heating plates each include a limit switch 865
(FIGS. 27A-27C) as described above to control heating and residence
time measurement for a medical item. The limit switch includes temperature
sensors 872, 886 disposed on limit switch arm 875 as described above
(FIG. 27A-27C) to measure medical item and excessive temperatures,
respectively.
A common system controller 930 (FIG. 32) enables entry of a desired
or set point temperature for each heating assembly and includes
a display 974 to display for each heating assembly the set point
temperature, medical item temperature and current residence time
of the medical item placed on that heating assembly. Thus, the system
enables each heating assembly to be individually controlled to the
same or different temperature. The display further provides a visual
indication for a heating assembly when excessive temperatures have
been detected for that heating assembly (e.g., an over temperature
(e.g., an "overtemp") indication) or when a medical item
is not present on that heating assembly (e.g., an "empty"
or "reload" indication). Exemplary display screens are
illustrated in FIGS. 31A-31B.
Display 974 is disposed toward an intermediate section of front
panel 918, while a control panel 975 is generally disposed in the
front panel adjacent the display. The control panel includes input
devices 976 (e.g., keys, buttons, switches, etc.) to facilitate
entry of information (e.g., enter or adjust set point temperature,
switch between Fahrenheit and Celsius, etc.) and a power switch
940 to enable power to the system. Alternatively, display 974 may
be implemented by a touch screen device to facilitate entry of information.
Various indicators 977 are further disposed adjacent display 974
to notify an operator of system conditions (e.g., power enabled,
etc.).
The system controller is in communication with heat controllers
952 (FIG. 33) each associated with a corresponding tray to individually
control each of the tray heating assemblies and measure residence
time. The system controller receives information entered by a user
and transfers that information to the heat controllers to facilitate
control of the heating assemblies. The heat controllers individually
control each heating assembly of a corresponding tray in accordance
with actuation of a corresponding limit switch, measured temperatures
from corresponding temperature sensors 872, 886 and the set point
temperature for that assembly received from the system controller.
The heat controllers further maintain the residence time of medical
items on the heating assemblies of the corresponding tray and may
store residence time in memory in order to recover and maintain
residence time measurements in the event of a power failure. The
system controller receives the medical item temperature and residence
time for the heating assemblies from the heat controllers for display
on display 974. Further, the heat controllers each report excessive
temperature detections and the presence of medical items for heating
assemblies of the corresponding tray to the system controller to
facilitate display of the excessive temperature and reload indications
for the heating assemblies. In addition, the heat controllers illuminate
heating assembly indicators 954 (e.g., LED), each disposed on a
tray 908 proximate a corresponding heating assembly to indicate
when a medical item on that heating assembly has attained or is
near (e.g., within a predetermined or user-specified range from)
the corresponding set point temperature.
Basically, when a medical item is placed on a heating plate and
limit switch as described above, the limit switch enters a closed
state and enables a corresponding heat controller to begin measuring
elapsed time. The elapsed time is sent to the system controller
for display on display 974, preferably in the format of hours, minutes
and seconds. However, the elapsed time may be measured and/or displayed
in any desired format or fashion (e.g., days, hours, minutes, seconds,
etc.). The limit switch further facilitates a time delay, where
the corresponding heat controller delays operation of the corresponding
assembly heater for a predetermined time interval. This delay enables
the temperature of a corresponding temperature sensor 872 to approach
the medical item temperature to provide enhanced temperature measurements
as described below. The medical item temperature, excessive temperature
detections and presence of the medical item for the heating assembly
are further sent to the system controller for display. When the
medical item is removed from the assembly heating plate, the limit
switch enters an open state, thereby causing the corresponding heat
controller to reset the time and disable heating. Thus, the display
notifies medical personnel of the residence time, temperature and
presence of medical items on corresponding heating assemblies, where
the residence time information informs medical personnel of the
amount of time a medical item has been warmed. Since medical items
typically have limits with respect to warming time, medical personnel
may remove the warmed medical item prior to excessive heating of
the medical item and reduction in effectiveness. Cabinet 904 may
include any quantity of rollers, trays, heating assemblies, power
switches, displays, indicators, controllers and accompanying control
circuitry, while the cabinet components (e.g., walls, door, panel,
etc.) may be arranged in any fashion.
An exemplary control circuit for system 900 is illustrated in FIG.
32. Specifically, control circuit 990 includes power conductors
901, 902, ground 907, power switch 940, system controller 930, display
974, a back light 932, a power source 934, input devices 976, indicators
977 and heat control circuits 950. The heat control circuits are
each associated with a corresponding tray 908 (FIG. 30) to individually
control the heating assemblies of that tray as described below.
Controller 930 is typically in the form of a motherboard including
a controller and accompanying circuitry. However, the system controller
may be implemented by any conventional or other controller, processor
and/or circuitry. Power conductors 901, 902 each include a respective
fuse 944, 946 that is arranged in series with power switch 940 to
prevent power surges from damaging the switch and circuitry. Power
switch 940 controls power to the circuitry and is connected to the
power source. The power switch is further connected to the heat
control circuits via a connection terminal 942.
Controller 930 is connected to power source 934, back light 932,
display 974, input devices 976 and indicators 977. Further, the
system controller is connected to (not shown) or in communication
with heat controllers 952 of heat control circuits 950, where the
communication or connection may be implemented in any desired fashion
(e.g., wires, busses, etc.). The power source provides appropriate
power signals (e.g., 12V DC) to the system controller, while the
back light is controlled by controller 930 to provide suitable lighting
conditions for the display. The system controller receives user
information from input devices 976 and illuminates appropriate indicators
977 based on the user information and system conditions (e.g., power
enabled, etc.). Set point temperature and other information received
by the system controller are distributed to heat control circuits
950 to facilitate heating of medical items as described below. The
system controller receives residence time, medical item temperature
and other information (e.g., excessive temperature detection, presence
of a medical item, etc.) from the heat control circuits and controls
display 974 to display information (e.g., residence time, medical
item temperature, excessive temperature detections, reload or empty
indications, etc.) for the heating assemblies. The display is generally
partitioned into sections with each section associated with a corresponding
heating assembly (e.g., the location of a section on the display
corresponds to the position of the associated heating assembly within
the cabinet) to provide information pertaining to that assembly
(FIGS. 31A-31B). The heating assemblies may each be associated with
an identifier that appears on the display to associate displayed
information with a corresponding heating assembly. However, the
display may be arranged in any fashion to provide information to
an operator.
An exemplary heat control circuit 950 is illustrated in FIG. 33.
Specifically, heat control circuit 950 receives information from
system controller 930 to control the heating assemblies of a corresponding
tray 908 (FIG. 30). The heat control circuit includes a heat controller
952 and further includes limit switch 865, heater 858 and temperature
sensors 872, 886 of each heating assembly of the corresponding tray.
The heat controller is preferably in the form of a daughterboard
with a controller and accompanying circuitry. However, the heat
controller may be implemented by any conventional or other controller,
processor and/or circuitry. The limit switch, heater and temperature
sensors are substantially similar to the ones described above. The
heat control circuit further includes indicators 954 each associated
with a heating assembly of the corresponding tray to indicate when
a medical item temperature of that heating assembly has attained
or is near the corresponding set point temperature.
Controller 952 is connected to temperature sensors 872, 886, heaters
858, limit switches 865 and indicators 954 of the tray heating assemblies.
The controller controls power applied to a heating assembly heater
in accordance with a comparison of a temperature measured by a corresponding
temperature sensor 872 and a desired temperature entered for that
heating assembly and received from system controller 930. In particular,
controller 952 receives temperature signals from a heating assembly
temperature sensor 872 indicating the temperature of a medical solution
container in contact with the sensor (i.e., the container disposed
on the heating plate surface). In response to the temperature measured
by the temperature sensor being equal to or exceeding a desired
temperature entered by a user for that heating assembly, the controller
disables power to the corresponding heater. Conversely, when the
temperature measured by the temperature sensor is below the desired
temperature, the controller enables power to the corresponding heater.
Limit switches 865 of the corresponding tray heating assemblies
are each connected to controller 952 and facilitate control of a
corresponding heater and residence time measurement in accordance
with the presence of a medical solution container on a corresponding
heating assembly. Controller 952 monitors the state of the limit
switches. For example, this may be accomplished by sending a signal
to each switch via a respective circuit and determining the presence
of a return signal from that switch. If a limit switch is in a closed
state, the respective circuit is completed and the return signal
may be detected. When a medical solution container is initially
placed on a heating plate, the corresponding limit switch enters
a closed state as described above. Accordingly, the heat controller
senses this condition and commences measuring elapsed time for the
medical item of that heating assembly. The heat controller may store
the elapsed time in memory in order to recover and maintain the
residence time measurement in the event of a power failure.
The heat controller further prevents enablement of the corresponding
heater for a predetermined time interval in response to the limit
switch closure. Preferably, the delay time interval is approximately
five minutes, however, the time interval may be set to any desired
interval. The time delay enables the temperature of a corresponding
temperature sensor 872 to approach the temperature of a new medical
item received on the heating plate to enhance temperature measurement.
Basically, the temperature of the temperature sensor is elevated
due to contact with a warmed medical item. When the warmed medical
item is removed from the system, the temperature sensor maintains
the elevated temperature for a short interval. Thus, the temperature
sensor in this state may provide elevated temperature readings relative
to the actual temperature of a new unwarmed medical item placed
on the heating plate. The time delay enables the temperature sensor
to cool and provide accurate temperature measurements. Once the
time delay interval has expired, controller 952 controls the corresponding
heater as described above.
When the medical item is removed from the heating plate and the
limit switch enters an open state, the heat controller detects this
condition and resets the time. Further, the heat controller disables
the corresponding heater. Thus, when the switch is in an open state
indicating no medical item on a heating plate, the timer is reset
and the corresponding heater is disabled.
Temperature sensors 886 of the heating assemblies of the corresponding
tray are each connected to the heat controller to facilitate disablement
of a corresponding heater in response to detecting a temperature
in excess of a predetermined threshold as described above. Basically,
temperature sensor 886 of a heating assembly provides a temperature
indication of the corresponding solution container, heater and/or
heating plate to controller 952. The heat controller disables power
to the corresponding heater in response to the measured temperature
exceeding a predetermined threshold as described above. The heat
controller transfers the residence time, medical item temperature,
excessive temperature detections and medical item presence information
for each heating assembly of the corresponding tray to the system
controller for display on display 974 as described above. This information
may be transmitted at any desired intervals for display by the system
controller. Control circuits 990 and 950 may alternatively be implemented
by any conventional circuitry components performing the above described
functions.
System 900 includes a configuration similar to that described above
for system 100 and may include report unit 101 and/or usage control
unit 1001 coupled to system controller 930 to generate, transmit
and/or print reports and/or control system usage as described above
for system 100. Heating assemblies 805 may each further include
an interface 20 in the form of a wireless transmitter/receiver (e.g.,
RF, infrared, etc.), bar code scanner or connector or port to communicate
with a medical item or identify the medical item to system 900 for
storage of monitored information as described above.
Operation of system 900 is described with reference to FIGS. 30-33.
Specifically, a user selects one or more medical solutions (e.g.,
bags or bottles containing saline or IV solutions, antibiotics or
other drugs, blood, etc.) for heating by the system and determines
the appropriate temperature for the solution. The solution container
may include the devices described above for solution bag 2. The
system may be transported to a desired site. The user subsequently
activates power switch 940 and opens door 928. The selected solution
containers are placed into the system on any desired heating plates.
Door 928 is subsequently pivoted to a closed state and desired
temperatures for the selected solutions are entered into the system
via input devices 976 as described above, where the solutions may
individually be heated by the heating assemblies to the same or
different temperatures. The system controller transmits the set
point temperature and other information to heat controllers 952
to control heating and measurement of residence time. The medical
solutions within the system may be viewed through the door. In response
to placement of a container on a heating plate bottom wall, the
container engages corresponding temperature sensor 872 and causes
closure of a corresponding limit switch 865. The switch closure
is detected by a corresponding heat controller 952 and initiates
measurement of elapsed time and the time delay. The heat controller
disables the corresponding assembly heater for the predetermined
time interval as described above. Once the time delay interval has
expired, the heat controller controls the corresponding heater (e.g.,
enables or disables power to the heater) in accordance with signals
from corresponding temperature sensor 872 as described above. The
heater applies heat to the corresponding heating plate bottom wall,
while the heating plate side walls conduct heat from the bottom
wall to evenly distribute heat to the container. A corresponding
temperature sensor 886 may be employed to facilitate disablement
of the heater in response to excessive heater, heating plate and/or
solution temperatures as described above.
Heat controllers 952 transfer the residence time, medical item
temperature, excessive temperature detection, medical item presence
and other information for the heating assemblies to system controller
930 for display on display 974 (FIGS. 31A-31B). When a medical item
on a heating assembly attains or is near a desired temperature,
the heat controller illuminates a corresponding indicator 954 as
described above. Moreover, system 900 may collect and provide information
or reports (e.g., FIGS. 12A-12I) and/or control system usage as
described above for system 100, where the reports or information
can be transmitted to internal printer 110, display 974 and/or to
a local or remote external device (e.g., printer, display, database,
medical item, etc.) as described above.
In response to attaining the desired temperature, the container
is removed from a heating plate via door 928. The corresponding
limit switch subsequently enters an open state, thereby resetting
the timer, disabling the corresponding heater and enabling display
of a reload or empty indicator for that heating assembly. A new
container may be placed on that heating plate, where the limit switch
enters a closed state and initiates residence time measurement,
delayed heating and display of information to repeat the process
for this container. The above process may be repeated for additional
containers or medical items. A user may utilize any quantity or
combination of heating assemblies in any fashion (e.g., within the
same or different trays) to heat medical items within the system.
In order to further assist medical personnel or users in complying
with the prescribed requirements for solution bag 2 or other medical
item, the present invention enables marking of the solution bag
with condition information as illustrated in FIG. 34. In particular,
the present invention includes placing time stamp information (e.g.,
time and/or date, the patient, solution and/or facility information
described above, etc.) on a medical item 1102 (e.g., medical solution
containers or bags, etc.) including insertion and/or removal times
of the item within a thermal treatment system (e.g., a heating and/or
cooling system). The time stamp information may be directly placed
on the medical item or be imprinted on a label for attachment to
the item as described below. The present invention enables users
to readily determine medical item compliance with regulatory and
medical item manufacturer requirements relating to medical item
heating time, temperature and/or other conditions in order to ensure
patient safety.
Specifically, system 1100 includes a marking device 1150 and thermal
treatment system 100. The thermal treatment system may be of any
of the types of systems described above, especially those accommodating
solution bags (e.g., FIGS. 10-11, 13-15, 18, 22, 27A and 30). The
marking device produces and places time stamp information on medical
item 1102 as described below. The medical item may include any of
the devices described above for solution bag 2. The placement of
information on the medical item occurs prior to insertion of the
medical item within the thermal treatment system. The time stamp
information basically pertains to the time the medical item is inserted
within the thermal treatment system. Thermal treatment system 100
thermally treats the medical item as described above, where the
time stamp information includes the medical item insertion time,
thereby enabling users to determine the time interval that the medical
item has been thermally treated. This ensures that the medical item
is treated for an appropriate time interval to maintain the medical
item efficacy as described above. The medical item may further receive
time stamp information from the marking device upon removal from
the thermal treatment system, thereby providing a record of the
thermal treatment time interval (e.g., the time stamp information
includes the insertion and removal times) and enabling medical personnel
to readily determine the time by which the medical item must be
utilized. The marking device may be implemented as a stand-alone
device or may be attached to or integral with the thermal treatment
system.
System 1100 may be used at any location where medical items are
used (e.g., the operating room, emergency room, Pre OP, Post OP,
patient's room, home, nursing home, etc.). It is to be understood
that the present invention marking system may be utilized with or
employ any type of thermal treatment system, such as the ones described
above and disclosed in the aforementioned patents, patent publications
and patent applications. The present invention marking system is
especially suitable for those thermal treatment systems measuring
medical item residence time, thereby providing time stamp and residence
time information to users or medical personnel to further ensure
appropriate thermal treatment intervals for medical items.
Medical item 1102 (FIG. 34) is preferably an intravenous solution
bag, but may be a wide variety of medical items (e.g., medical solution
containers, saline solutions, IV solutions and/or lines, instruments,
blankets, antibiotics or other drugs, blood, irrigation fluid and/or
lines, etc.). An exemplary medical item in the form of an intravenous
solution bag for use with the present invention and having time
stamp information placed thereon is illustrated in FIG. 35A. Specifically,
intravenous solution bag 1102 is similar to the bags described above
and is preferably implemented by a conventional intravenous solution
bag constructed of plastic or other materials commonly utilized
for forming those types of bags. The solution bag may contain various
types of solutions, such as saline solution, blood, antibiotic or
other drugs, or any other intravenously administered solution. Intravenous
solution bag 1102 further includes generally triangular projection
4 attached to and extending from the bag upper portion. Projection
4 preferably includes a truncated upper portion having opening or
hole 6 defined therein for interfacing an intravenous pole or other
support structure (not shown) as described above. The bag lower
portion includes outlet 7 and associated fluid conduits 15 to interface
an intravenous tube (not shown) and enable the solution to flow
through the tube from the outlet to a patient as described above.
Generally, intravenous solutions are required to be within a specific
temperature range during infusion to avoid injury to a patient as
described above. The solutions typically have a prescribed heating
time and utilization life in order to maintain their efficacy as
described above. The present invention marking system provides time
stamp information for placement on the bag in order to ensure compliance
with prescribed requirements (e.g., appropriate heating intervals,
etc.). Specifically, time stamp information 1110 may be placed directly
on the bag. This may be accomplished by any conventional or other
techniques (e.g., a physical impression on the solution bag (with
or without ink), a printed indicator by dot matrix, laser printing
or thermal techniques, etc.).
Alternatively, time stamp information 1110 can be printed onto
a self-adhesive label to be adhered to the solution bag. This label
receives time stamp information and is adhered to the bag prior
to the bag being placed in the thermal treatment system. The label
adhesive may be sufficiently strong to prevent removal of the label
from the bag and/or label tampering. The strength of the label adhesive
may alternatively enable a user to remove the label from the bag
for attachment to a chart. The label may be of any size or shape
and may be of any type of printing material (e.g., paper, thermal
paper, fabric, etc.). Further, the label may include areas or fields
to receive specific time stamp information from the marking device
(e.g., entry time into the thermal treatment system, removal time,
date, the facility information described above, solution and/or
patient, etc.). By way of example only, the time stamp information
is placed on the bag adjacent projection 4, however, the time stamp
information may be disposed at any location on the bag and be arranged
in any fashion to cover areas of any size or shape.
Intravenous solution bag 1102 may alternatively be encased in a
liner or overwrap as illustrated in FIG. 35B. Specifically, intravenous
solution bag 1102 is substantially similar to the solution bag described
above for FIG. 35A, except that the solution bag is disposed within
a liner or overwrap 1114. Liner 1114 may be constructed of any type
of plastic or other suitable materials (e.g., materials of the type
utilized to form the solution bag), and preferably has dimensions
slightly greater than the dimensions of solution bag 2 to receive
and house the solution bag. Liner 1114 is preferably sealed along
its edges via any conventional or other fastening techniques. The
time stamp information may be placed directly on the liner via any
conventional or other techniques (e.g., a physical impression on
the liner, a printed indicator by dot matrix, laser printing or
thermal techniques, etc.) as described above. Alternatively, time
stamp information 1110 can be printed onto a self-adhesive label
to be adhered to the liner as described above. By way of example
only, the time stamp information is placed on the liner toward projection
4, however, the time stamp information may be disposed at any location
on the liner.
An exemplary marking device employed by the present invention is
illustrated in FIG. 36. Specifically, marking device 1150 includes
a housing (not shown) including a processor 1152, a display 1156,
an article sensor or switch 1158, input devices 1160 and a marking
or printing unit 1162. Processor 1152 may be implemented by any
conventional or other microprocessor and controls device operation.
The processor further maintains time stamp information (e.g., time,
date, etc.) for placement on a medical item. The processor is coupled
to input devices 1160 typically disposed on the housing exterior
to receive information entered by a user. This information may include
time and/or date settings, various device parameters and any desired
information for the time stamp information (e.g., the facility,
patient and/or solution information described above, type of item,
etc.). Input devices 1160 may be implemented by any conventional
or other input devices (e.g., buttons, keys, switches, keypad, etc.).
Display 1156 is coupled to processor 1152 and may be implemented
by any conventional or other display (e.g., LED, LCD, etc.). The
display is typically disposed on the housing exterior and may provide
any desired information to a user (e.g., time stamp information,
current date and/or time, etc.).
The marking device housing includes a marking area enabling switch
1158 and printing unit 1162 to engage an article (e.g., medical
item or label) for receiving time stamp information. In particular,
switch 1158 is coupled to processor 1152 and may be implemented
by any conventional or other sensor or switch. The switch provides
a signal to the processor to indicate the presence of an article
within the marking area to receive time stamp information. Basically,
an article is positioned in the marking area to receive time stamp
information from the printing unit. The switch is disposed in the
marking area in a manner that enables the article to actuate the
switch in response to the article positioning. The switch provides
a signal to the processor to initiate marking of the article as
described below.
Processor 1152 is further coupled to printing unit 1162. The printing
unit may be implemented by any conventional or other devices capable
of placing the time stamp information on the article. For example,
the printing unit may be implemented by a conventional printer to
print the time stamp information on the article (e.g., via conventional
dot matrix, ink jet, laser printing, and/or thermal printing techniques).
Alternatively, the printing unit may be implemented by devices imprinting
or impressing (with or without ink) the time stamp information onto
the article surface. This may be accomplished via conventional laser
or thermal techniques or plate type impressions onto the article.
Processor 1152 receives the signal from switch 1158 and initiates
the printing unit to place the time stamp information on the article.
The time stamp information (or any portion thereof) may further
be printed or marked in the form of a bar code or other indicator
to enable this information to be scanned for entry into a computer
or other system for processing.
Marking device 1150 may alternatively be implemented by any conventional
or other marking devices providing time stamp information, such
as a Pix-15 available from Amano Electronics, Inc. and the types
of devices disclosed in U.S. Pat. Nos. 6,061,303 (Gauthier et al)
and U.S. Pat. No. 6,527,462 (Arledge et al), the disclosures of
which are incorporated herein by reference in their entireties.
The time stamp information may include any desired information
and may be arranged in any desired format. Typically, the time stamp
information includes at least the year, day of the year (e.g., month
and day) and time of day. The time stamp information may be in the
form of text and read by an operator and/or in the form of a bar
code or other indicator for scanning by a reader as described above.
Labels with time stamp information are illustrated, by way of example
only, in FIGS. 37A-37B. Specifically, the labels include an area
or field for the time stamp information and are typically pre-printed
with descriptive information (e.g., Time/Date In, Time/Date Out,
etc.) adjacent the field to indicate to a user the relevancy of
the time stamp information. For example, the label in FIG. 37A includes
descriptive information (e.g., Time/Date In) indicating that time
stamp information 1110 pertains to the insertion time of a medical
item into a thermal treatment system. The label of FIG. 37B includes
descriptive information (e.g., Time/Date Out) indicating that time
stamp information 1110 pertains to the removal time of the medical
item from the thermal treatment system. The time stamp information
produced by the marking device includes the year (e.g., in a 'YY
format (an apostrophe followed by the last two digits of the year)),
month (e.g., in a MMM format (the first three letters of the month)),
day of the month (e.g., in a DD format (one or two digits)) and
time (e.g., with an AM/PM indication followed by an HH:MM format
(one or two digits for the hour and two digits for the minutes)).
However, the time stamp information may be presented in any desired
formats. The time stamp information is placed on each article (e.g.,
medical item or label) presented to the marking device for marking.
The labels may include any desired quantity of fields with any
type of descriptive information. Alternatively, the labels may be
blank, where the marking device provides the time stamp and descriptive
information. The descriptive information may be provided pre-printed
on the label or by the marking device in any combination. Further,
the labels may be presented to the marking device for receiving
time stamp information, where the stamped labels may subsequently
be adhered to the medical item by the user via various techniques
(e.g., adhesive, fastener, self-adhesive label, etc.). Alternatively,
the medical item may include the label already attached and be presented
to the marking device to receive the time stamp information. In
addition, the medical item may include any descriptive information
and/or fields and may directly receive the time stamp information
from the marking device (e.g., via printing or impression techniques)
at any desired locations as described above.
Operation of the system is described with reference to FIG. 34.
Specifically, medical item 1102, preferably a solution bag, is initially
retrieved for a medical procedure. The bag may include any of the
devices or indicia described above for solution bag 2. The bag is
typically required to have the desired utilization temperature prior
to use as described above. When the bag requires thermal treatment
to attain the desired utilization temperature, the bag is received
by marking device 1150 at flow 1120. The marking device maintains
time stamp information (e.g., time, date, the facility, patient
and/or solution information described above, etc.) and may place
any desired information (e.g., typically time and date information)
directly on the bag as described above. Alternatively, the marking
device may place this information on a label for attachment to the
bag as described above.
Once the time stamp information has been placed on the bag, the
bag is disposed within thermal treatment system 100 at flow 1122.
The time stamp information placed on the bag basically pertains
to the time the bag is placed in the thermal treatment system. The
thermal treatment system is operated to thermally treat the bag
to a desired temperature suitable for use in the medical procedure
as described above. The medical item and/or thermal treatment system
may measure, collect, transmit and/or print medical solution information
locally or externally as described above. The time stamp information
enables users to determine the heating or residence time of the
bag within the system in order to ensure the bag is heated for an
appropriate time interval to comply with prescribed procedures and
maintain its efficacy.
When the bag has attained a desired temperature, the bag is removed
from thermal treatment system 100 for utilization in the medical
procedure. Alternatively, the bag may be removed from the thermal
treatment system and be received by marking device 1150 at flow
1124 in order to provide further time stamp information on the bag
(or label) pertaining to removal of the bag from the thermal treatment
system. This additional time stamp information provides a record
of the bag heating time.
The present invention thus provides monitoring conditions of medical
solution or other medical items at each and/or any stage during
the life of that item from manufacture to disposal (e.g., from manufacturing,
through storage prior to and/or during transport, through storage
at an intended facility, through thermal treatment at a facility,
etc.). Accordingly, the precise status of the medical solution with
respect to prescribed requirements (e.g., medical regulations or
standards, manufacturer requirements, etc.) may be indicated to
users and/or medical personnel to prevent non-compliant items from
being utilized or administered to patients.
It will be appreciated that the embodiments described above and
illustrated in the drawings represent only a few of the many ways
of implementing medical item thermal treatment systems and method
of monitoring medical items for compliance with prescribed requirements.
The present invention medical items and thermal treatment systems
may be utilized individually or in any combination to monitor any
types of medical items for compliance with any types of requirements
(e.g., manufacturer, medical personnel, medical standard or regulation,
etc.). The present invention may monitor the items and/or indicate
the status (e.g., compliance or non-compliance with prescribed requirements)
to any users or medical personnel through each or any of the stages
of the medical item life (e.g., from manufacture through use and/or
disposal).
The monitoring device may be of any quantity, shape or size and
may be disposed at any location on or within the medical item via
any conventional or other techniques (e.g., adhesive, welding, lamination,
floatation devices for placement in solution, etc.). The monitoring
device may include any quantity of any types of conventional or
other sensors (e.g., proximity sensors, pressure sensors, temperature
sensors (e.g., RTD, infrared, etc.), presence sensors, weight sensors,
volume sensors, flow sensors, fluid sensors, fluid level sensors,
etc.) to measure and provide any information. The processor may
be implemented by any conventional or other microprocessor. Software
for the processor may be implemented in any desired computer language
and could be developed by one of ordinary skill in the computer
arts based on the functional descriptions contained herein. The
processor may alternatively be implemented by any type of hardware,
software and/or other processing circuitry, and may be available
pre-programmed for immediate use. The various functions of the processor
may be distributed in any manner among any quantity of software
modules, processors and/or circuitry. The algorithms and/or processes
described above may be modified in any manner that accomplishes
the functions described herein.
The monitoring device may compare measured values or other information
to any desired requirements to indicate compliance with those requirements.
For example, the monitoring device may examine the record of medical
item conditions and determine and/or indicate that the medical item
has been previously warmed (e.g., based on recorded temperatures)
to prevent re-warming of the medical item. Further, the monitoring
device may determine and/or indicate when the medical item has been
inserted into and/or removed from a thermal treatment system (e.g.,
based on temperature variations in the record) and/or the subsequent
time within which the item must be used (e.g., medical items may
have a use time after thermal treatment). Moreover, the monitoring
device monitors medical item conditions during storage (or non-use)
to ensure that higher temperature exposure does not accelerate changes
in the item (e.g., efficacy) and/or that the medical item remains
pharmaceutically acceptable. In addition, the monitoring device
may examine fluid level information (e.g., in the record or as the
information is being measured) to indicate the amount of fluid or
when a particular dosage has been administered. The monitoring device
may indicate any conditions on the display and/or indicators.
The display may be of any quantity, size or shape, may be implemented
by any conventional or other display (e.g., LCD, LED, etc.) and
may display any desired information. The display may be disposed
at any desired location on the medical item and utilize any symbols
or characters (e.g., alphanumeric, punctuation, icons, etc.) to
indicate compliance with conditions. The indicators may be of any
quantity or type (e.g., LEDs or other illuminating devices of any
colors, etc.) and may be disposed at any desired locations on the
medical item. Any quantity of indicators may be associated with
a particular condition and may be illuminated or actuated in any
fashion (e.g., brightness, flashing, colors, etc.) to indicate that
condition. Further, the monitoring device may include any quantity
of any type of visual and/or audio indicators (e.g., speech synthesis,
beep, buzzer, etc.) to indicate conditions.
The interface may be implemented by any conventional or other interface
(e.g., wireless, RF, infrared, cable, connector, etc.) and utilize
any desired protocol to communicate with an external device. The
external device may be in the form of any processing device (e.g.,
computer system, hand-held receiver, PDA, etc.) to communicate with
and retrieve information from the monitoring device. The external
device may provide any desired information to the monitoring device
(e.g., entered by a user, etc.). The external device may store retrieved
information in any type of storage unit (e.g., file, local or remote
database or other memory or storage unit, etc.) for access by users
for any desired purposes (e.g., tracking, inventory, reviewing item
history, etc.). The monitoring device may include any type of location
devices (e.g., GPS, homing device, transmitter, etc.) to provide
location information for the medical item. The monitoring device
may utilize any quantity of any type of power source (e.g., batteries,
etc.) and may include a unique identifier of any desired length
of any types of characters or symbols (e.g., alphanumeric, etc.).
The monitoring device may be disposable with the medical item or
re-programmed for use with subsequent medical items.
The memory device may be of any quantity, shape or size and may
be disposed at any location on or within the medical item via any
conventional or other techniques (e.g., adhesive, welding, lamination,
floatation devices for placement in solution, etc.). The memory
device processor may be implemented by any conventional or other
microprocessor. Software for the processor may be implemented in
any desired computer language and could be developed by one of ordinary
skill in the computer arts based on the functional descriptions
contained herein. The processor may alternatively be implemented
by any type of hardware, software and/or other processing circuitry,
and may be available pre-programmed for immediate use. The various
functions of the processor may be distributed in any manner among
any quantity of software modules, processors and/or circuitry. The
algorithms and/or processes described above may be modified in any
manner that accomplishes the functions described herein.
The processor may compare measured values or other information
to any desired requirements to indicate compliance with those requirements.
For example, the memory device may examine the record of medical
item conditions and determine and/or indicate that the medical item
has been previously warmed (e.g., based on recorded temperatures)
to prevent re-warming of the medical item. Further, the memory device
may determine and/or indicate when the medical item has been inserted
into and/or removed from a thermal treatment system (e.g., based
on received information or temperature variations in the record)
and/or the subsequent time within which the item must be used (e.g.,
medical items may have a use time after thermal treatment). Moreover,
the memory device enables monitoring of medical item conditions
to ensure that higher temperature exposure does not accelerate changes
in the item (e.g., efficacy) and/or that the medical item remains
pharmaceutically acceptable. The memory device may indicate any
conditions on the display and/or indicators.
The memory device display may be of any quantity, size or shape,
may be implemented by any conventional or other display (e.g., LCD,
LED, etc.) and may display any desired information. The display
may be disposed at any desired location on the medical item and
utilize any symbols or characters (e.g., alphanumeric, punctuation,
icons, etc.) to indicate compliance with conditions. The memory
device indicators may be of any quantity or type (e.g., LEDs or
other illuminating devices of any colors, etc.) and may be disposed
at any desired locations on the medical item. Any quantity of indicators
may be associated with a particular condition and may be illuminated
or actuated in any fashion (e.g., brightness, flashing, colors,
etc.) to indicate that condition. Further, the memory device may
include any quantity of any type of visual and/or audio indicators
(e.g., speech synthesis, beep, buzzer, etc.) to indicate conditions.
The memory device interface may be implemented by any conventional
or other interface (e.g., wireless, RF, infrared, cable, connector,
etc.) and utilize any desired protocol to communicate with an external
device. The external device may be in the form of any processing
device (e.g., thermal treatment system, computer system, hand-held
receiver, PDA, etc.) to communicate with and retrieve and/or provide
information. The external device may provide any desired information
to the memory device (e.g., entered by a user, etc.). The external
device may further store information in any type of storage unit
(e.g., file, local or remote database or other memory or storage
unit, etc.) for access by users for any desired purposes (e.g.,
tracking, inventory, reviewing item history, etc.). The memory device
may utilize any quantity of any type of power source (e.g., batteries,
etc.) and may include a unique identifier of any desired length
of any types of characters or symbols (e.g., alphanumeric, etc.).
The memory device may be disposable with the medical item or re-programmed
for use with subsequent medical items.
The bar code and/or transponder unit may be of any quantity, shape
or size and may be disposed at any location on or within the medical
item via any conventional or other techniques (e.g., adhesive, welding,
lamination, floatation devices for placement in solution, etc.).
The transponder unit processor may be implemented by any conventional
or other microprocessor. Software for the processor may be implemented
in any desired computer language and could be developed by one of
ordinary skill in the computer arts based on the functional descriptions
contained herein. The processor may alternatively be implemented
by any type of hardware, software and/or other processing circuitry,
and may be available pre-programmed for immediate use. The various
functions of the processor may be distributed in any manner among
any quantity of software modules, processors and/or circuitry. The
algorithms and/or processes described above may be modified in any
manner that accomplishes the functions described herein.
The transceiver may be implemented by any conventional or other
transceiver (e.g., wireless, RF, infrared, cable, connector, etc.)
to communicate with the thermal treatment system or other external
device (e.g., processing device or system, computer system, hand-held
receiver, PDA, etc.). The thermal treatment system or other external
device may provide any desired information to the transponder unit
(e.g., entered by a user, etc.). The thermal treatment system or
other external device may store information in any type of storage
unit (e.g., file, local or remote database or other memory or storage
unit, etc.) for access by users for any desired purposes (e.g.,
tracking, inventory, reviewing item history, etc.). The thermal
treatment system or other external device may compare measured values
or other information to any desired requirements to indicate compliance
with those requirements. For example, the thermal treatment system
or other external device may examine the record of medical item
conditions and determine and/or indicate that the medical item has
been previously warmed (e.g., based on recorded temperatures) to
prevent re-warming of the medical item. Further, the thermal treatment
system or other external device may determine and/or indicate when
the medical item has been inserted into and/or removed from a thermal
treatment system (e.g., based on information from the thermal treatment
system or temperature variations in the record) and/or the subsequent
time within which the item must be used (e.g., medical items may
have a use time after thermal treatment). Moreover, the thermal
treatment system or other external device monitors medical item
conditions to ensure that higher temperature exposure does not accelerate
changes in the item (e.g., efficacy) and/or that the medical item
remains pharmaceutically acceptable. The thermal treatment system
or external device may indicate any conditions via a display and/or
indicators. The thermal treatment system or external device may
include any quantity of any type of visual and/or audio indicators
(e.g., speech synthesis, beep, buzzer, etc.) to indicate conditions.
The transponder unit may utilize any quantity of any type of power
source (e.g., batteries, etc.). The bar code and transponder unit
may provide a unique identifier of any desired length of any types
of characters or symbols (e.g., alphanumeric, etc.). The transponder
unit may be disposable with the medical item or re-programmed for
use with subsequent medical items.
The ink cells may be of any quantity of any type of conventional
or other ink cells. The ink cells may be disposed at any desired
locations on the medical item in any desired arrangement. The cells
may alternatively be disposed in any fashion on any quantity of
labels of any shapes or sizes and adhered or disposed on the medical
item at any desired locations. Any quantity of cells may be associated
with a particular condition and may be activated in any fashion
(e.g., change colors, dark to light, light to dark, etc.) to indicate
that condition. The ink cells may be utilized to indicate any desired
conditions.
The control circuit may be disposed on or remote from the medical
item. The control circuit or external device (e.g., thermal treatment
system, processing system or device, transport container or housing,
etc.) may include any quantity of any types of conventional or other
sensors (e.g., proximity sensors, pressure sensors, temperature
sensors (e.g., RTD, infrared, etc.), presence sensors, weight sensors,
volume sensors, flow sensors, fluid sensors, fluid level sensors,
etc.) to measure and provide any information. The control circuit
processor may be implemented by any conventional or other microprocessor.
Software for the processor may be implemented in any desired computer
language and could be developed by one of ordinary skill in the
computer arts based on the functional descriptions contained herein.
The processor may alternatively be implemented by any type of hardware,
software and/or other processing circuitry, and may be available
pre-programmed for immediate use. The various functions of the processor
may be distributed in any manner among any quantity of software
modules, processors and/or circuitry. The algorithms and/or processes
described above may be modified in any manner that accomplishes
the functions described herein.
The processor may compare measured values or other information
to any desired requirements to indicate compliance with those requirements.
For example, the control circuit (or external device) may examine
the record of medical item conditions and determine and/or indicate
(e.g., via the ink cells) that the medical item has been previously
warmed (e.g., based on recorded temperatures) to prevent re-warming
of the medical item. Further, the control circuit (or external device)
may determine and/or indicate (e.g., via the ink cells) when the
medical item has been inserted into and/or removed from a thermal
treatment system (e.g., based on information from a thermal treatment
system or temperature variations in the record) and/or the subsequent
time within which the item must be used (e.g., medical items may
have a use time after thermal treatment). Moreover, the control
circuit (or external device) may monitor medical item conditions
during storage (or non-use) to ensure that higher temperature exposure
does not accelerate changes in the item (e.g., efficacy) and/or
that the medical item remains pharmaceutically acceptable. The control
circuit (or external device) may indicate any conditions on the
display and/or indicators.
The clip may be implemented by any quantity of any type of connector
to connect the cells to the external device or control circuit.
The clip may be disposed at any location on the medical item. The
cells may be manually activated by any quantity of any type of actuator
(e.g., button, switch, etc.) disposed at any locations on or remote
from the medical item. The ink cells and/or control circuit may
utilize any quantity of any type of power source (e.g., batteries,
etc.).
Thermal treatment system 100 may include any conventional or other
heating and/or refrigeration units to thermally treat the medical
items to any desired temperature. The monitoring sensors may be
implemented by any quantity of any conventional or other sensors
(e.g., proximity sensors, pressure sensors, temperature sensors
(e.g., RTD, infrared, etc.), presence sensors, weight sensors, volume
sensors, flow sensors, fluid sensors, fluid level sensors, etc.)
to measure and provide any desired information to the report controller
and/or usage control unit and may be disposed at any location. The
system may be powered by any conventional or other power source
(e.g., AC, DC, wall outlet jack, batteries, etc.).
The temperature controller may be implemented by any quantity of
any conventional or other temperature controller or processor (e.g.,
chip, card, processor, circuitry, etc.) and include any quantity
of any desired input devices (e.g., buttons, keypad, etc.). The
temperature controller may control the heater/cooler units to any
desired temperature range, and may utilize any quantity of set points
(e.g., maximum and/or minimum, etc.). The system may record any
type of information (e.g., date and time of thermal treatment disablement
and enablement, fluid level or loss, etc.) relating to system operation
for subsequent retrieval, analysis, display, display/report (e.g.,
date and time of thermal treatment disablement and enablement, fluid
level or loss, etc.) and control functions supported by the system.
The report controller may be implemented by any conventional or
other microprocessor or controller (e.g., chip, card, processor,
circuitry, etc.) and include any quantity of any desired input devices
(e.g., buttons, keypad, etc.). The report controller may maintain
the date, elapsed heating/cooling time and/or occurrence time of
any event or condition (e.g., time medical items are inserted and/or
removed within the system, etc.). The report controller may measure
the elapsed time or record an occurrence time for any desired condition.
The report controller may maintain the time information internally
or utilize any desired external circuitry (e.g., a timer, etc.).
The report controller may collect any desired information (e.g.,
start date and time of solution or other item heating/cooling, the
time interval the solution or other item was heated/cooled, the
temperature the solution or other item attained during heating/cooling,
temperature of the solution or other item when the solution was
removed from the system, amount or quantity of solution or other
item residing, placed in or removed from the system, partial or
complete history of time and solution or other item temperature
measured at any desired time intervals, facility information, patient
information, doctor information, type of procedure, solution information,
type of instruments or other item being heated/cooled, amount or
quantity of solution or other item being heated/cooled, etc.) from
any desired sources (e.g., temperature controller, user, memory,
another computer or device, etc.). The report controller may implement
or be implemented by the temperature controller. The monitoring
sensors may be coupled to the temperature controller, system interface
and/or report controller either individually or in any combination
or fashion.
The reports may be arranged in any fashion and include any desired
information. The date, time and other information may be in any
desired format (e.g., month, day and year, hours and minutes, text,
numeric, icons, etc.). The report information may be arranged and/or
presented (e.g., printed, displayed, etc.) in any desired formats
(e.g., text, charts, graphs, columns, rows, tables, etc.) and in
any order or arrangement. The graph may include any quantity of
axes each associated with any desired information (e.g., time, temperature,
etc.) in any desired scales or units (e.g., Celsius, Fahrenheit,
etc.). The graphs may utilize any types of symbols or characters
(e.g., dots, diamonds, dashes, alphanumeric characters, punctuation
symbols, etc.) to indicate points on the graph. The graphs may indicate
time, temperature or events (e.g., removal of solution, etc.) in
any fashion. The reports may provide information (e.g., temperature,
etc.) measured or collected at any desired preset or user specified
time intervals (e.g., hours, minutes, seconds, etc.). The time intervals
may be specified by a user via any input devices (e.g., temperature
or report controller input devices (e.g., keys, buttons, etc.),
remote or local computer, etc.). The report and/or information may
alternatively be stored in a local or remote database or memory
device (e.g., local memory, removable memory, etc.) for later retrieval.
The reports may include a pre-arranged format or may be programmable
or selected by a user via report controller input devices. The system,
controller and other displays may be of any quantity, shape or size,
may be disposed at any location on or remote from the system, may
be implemented by any conventional or other displays (e.g., LED,
LCD, etc.) and may display any desired information. The information
displayed may be selected via temperature controller or report controller
input devices, or the display may include display controls (e.g.,
buttons, keys, etc.).
The internal printer may be implemented by any conventional or
other printing device, may be local or remote, may serve any quantity
of systems or other devices, and may produce reports on any desired
medium (e.g., paper, labels, etc.). The reports may be printed and/or
displayed concurrently with system operation as report data is collected
or at any specific time or in response to user entered information
(e.g., a print command or key). The report may be printed at any
desired time before, during or after system use, and may be retrieved
from the system at any desired time or in any desired manner that
preserves a sterile field (e.g., after completion of the medical
procedure, times when a sterile field is not needed or being employed
by the system, etc.). The system or report controller may include
any conventional or other communications device or module (e.g.,
modem, etc.) and may download or transfer an electronic form of
the report to any desired device (e.g., PDA, computer, another system,
etc.) at any specific time or in response to user entered information
(e.g., transmit command or key). The system may further be networked
to enable retrieval of reports and/or information from a station
coupled to the network. The printer and displays may be disposed
at any suitable locations on or remote from the system. Alternatively,
the system may be implemented to generate reports without the printer
and/or display. Any desired information may be transmitted between
the system components (e.g., temperature controller, report controller,
printer, displays, etc.) via any conventional or other communications
medium or protocols (e.g., hardwire, wireless, network, etc.).
Software for the temperature controller and report controller may
be implemented in any desired computer language and could be developed
by one of ordinary skill in the computer arts based on the functional
descriptions contained herein. The temperature controller and/or
report controller may alternatively be implemented by any type of
hardware and/or other processing circuitry, and may be available
pre-programmed for immediate use. The various functions of the temperature
controller and/or report controller may be distributed in any manner
among any quantity of software modules, processors and/or circuitry.
The system interface, computer interface and communications device
of the usage control unit may be implemented by any quantity of
any conventional or other microprocessor or controller (e.g., chip,
card, processor, circuitry, etc.) and include any quantity of any
desired input devices (e.g., buttons, keypad, etc.). The computer
interface may be in the form of a read/write unit to transfer information
to the computer system. The system and computer interfaces may be
of any quantity and accommodate any quantity of information devices.
The communications device may include any quantity of any conventional
or other devices (e.g., modem, router, etc.) for communications
with the network or other devices. The system interface and communications
device may maintain the date, elapsed heating/cooling time and/or
occurrence time of any event or condition (e.g., time medical items
are inserted and/or removed within the system, etc.) and may measure
the elapsed time or record an occurrence time for any desired condition.
The system interface and communications device may maintain the
time information internally or utilize any desired external circuitry
(e.g., a timer, etc.).
The system interface and communications device may collect any
desired information (e.g., the date/time that a medical item was
placed into/removed from the medical item warming/cooling system,
the temperature of the medical item upon being placed into/removed
from the medical item warming/cooling system, the temperature of
the medical item at specific points in time while stored in the
medical item warming/cooling system, start date and time that the
medical item began to be heated/cooled, the length of time that
the medical item was heated/cooled, the temperature that the medical
item was heated/cooled to during the heating/cooling cycle and/or
the amount of solution or other item residing, placed in or removed
from the system, patient information, thermal treatment system information
(e.g., type, identification or serial number, etc.), user information
(e.g., access or account identification or code, passwords, etc.),
facility information, doctor information, the type of procedure,
solution information, the type of item being heated/cooled, the
amount or quantity of fluid or other item being heated/cooled (e.g.,
fluid (or other item) level, volume or weight), the flow rate of
fluid that is being heated/cooled, the pressure of fluid flow as
the fluid is heated/cooled and any other desired information) from
any desired sources (e.g., temperature controller, user, memory,
another computer or device, etc.). Information (e.g., user, system,
facility, patient and/or doctor information, etc.) may be pre-stored
on the information device and/or entered by a user via system, interface
or communication device input devices (e.g., keypad, etc.). The
recordation or collection of information may occur automatically
or via user entered information (e.g., start, stop and/or record
keys). The system interface and/or communications device may implement
or be implemented by the temperature controller. The monitoring
sensors may be coupled to the temperature controller, report unit,
system interface and/or communications device either individually
or in any combination or fashion.
The information device may be of any shape or size, may be implemented
by any type of device including any type of memory or storage (e.g.,
a microprocessor with memory, a chip, a floppy, magnetic or optical
disk, CD-ROM, USB disk, smart card, etc.) and may contain any desired
information. The information device may include any pre-stored information
and may be coupled to the thermal treatment system, computer system,
system interface or computer interface via any conventional or other
techniques (e.g., direct connection, infrared, RF transmission,
cellular, Bluetooth, etc.). The system interface, communications
device and/or computer interface may be disposed internal or external
of the respective thermal treatment and computer systems. The system
interface may further be in communication with a local or remote
computer system (e.g., via network, cables, wireless transmission,
etc.) to transfer and receive information (without use or in addition
to the computer interface).
The system and computer interfaces may engage or receive the information
device in any fashion. The information device may include any storage
and/or processing capabilities. For example, the information device
may perform the functions of the system interface, where the system
interface in this case basically couples the information device
to the thermal treatment system (e.g., temperature controller and/or
sensors). The information device may include any degree of intelligence,
where the functions of the system interface may be distributed in
any fashion among the system interface and information device. Further,
the information device may include processing to generate desired
reports and displays for transfer to other devices (e.g., computer
systems, monitors, etc.). The information device may be removable
with respect to the thermal treatment system, system interface and
computer interface and may be transported between the devices in
any fashion (e.g., the user, mechanical devices, etc.).
Use of a medical item thermal treatment system can be authorized
based upon any single or combination of quantifiable authorized
use parameters or metrics (e.g., a calendar/time period during which
the medical item thermal treatment system is authorized for use,
a number of warming/cooling cycles for which the medical item thermal
treatment system is authorized for use, a number of medical items
for which the medical item thermal treatment system is authorized
for use, type of use (e.g., heating, cooling, heating and cooling,
etc.), maximum number of medical items, power usage, etc.). Authorized
use can be associated with a user authorization code or password
that can include any number, character string, array, or combination
thereof that is interpreted by a medical item thermal treatment
system to authorize or limit use of any capability or function supported
by the medical item thermal treatment system.
Operational or control parameters used to control operation of
the medical item thermal treatment system can include any parameter
that can be used to specify an operational instruction or performance
characteristic (e.g., a user access code, type of medical item accepted,
a desired temperature for medical items, a maximum duration that
a medical item (e.g., IV solution, blood, etc.) is allowed to remain
in the thermal treatment system, time and/or temperature thresholds
to be used in controlling alarms, log event definitions, timeouts,
timer periods, various threshold values, log messages, storage destinations,
etc.). Temperature profiles can be used as control parameters to
control the rate of temperature increase/decrease and manner of
maintaining the temperature of any medical item. Alert thresholds
can be used as control parameters to control the issuance of alarms
and/or to initiate a response (e.g., storing critical information,
disabling a warming/cooling unit, etc.). The alert thresholds may
be within any desired range of an alert condition (e.g., temperature,
exhaustion of use, etc.). The systems may include any type of visual
and/or audio alarms (e.g., lights, beeps, flashes, synthesized voice,
etc.) disposed at any suitable locations. Data collection instructions
can be used as control parameters to control what sensor information
is stored, the format in which it is stored, how often the information
is polled and/or stored, and/or where information is to be stored.
Display parameters can be used as control parameters to control
the content and arrangement of generated displays and reports. Alternatively,
the thermal treatment systems may receive the usage and control
parameters in any desired fashion (e.g., from a remote or local
computer or other device, from user entry via input devices, etc.).
Displays and reports can be generated by any number of local and/or
remote devices with access to the collected or stored thermal treatment
system information. Displays and reports can be generated by any
number of special purpose or generic display and report generators.
A generated display or report can be presented to a user via the
same device that generates the display or report and/or at one or
more locally or remotely located display or printing devices. The
displays and reports may be arranged in any fashion and include
any desired information. Date, time and other display or report
information may be in any desired format (e.g., month, day and year,
hours and minutes, text, numeric, icons, etc.). The display or report
information may be arranged and/or presented (e.g., printed, displayed,
etc.) in any desired formats (e.g., text, charts, graphs, columns,
rows, tables, etc.) and in any order or arrangement. The graph may
include any quantity of axes each associated with any desired information
(e.g., time, temperature, etc.) in any desired scales or units (e.g.,
Celsius, Fahrenheit, etc.). The graphs may utilize any types of
symbols or characters (e.g., dots, diamonds, dashes, alphanumeric
characters, punctuation symbols, etc.) to indicate points on the
graph. The graphs may indicate time, temperature or events (e.g.,
removal of solution, etc.) in any fashion. The displays and reports
may provide information (e.g., temperature, etc.) measured or collected
at any desired preset or user specified time intervals (e.g., hours,
minutes, seconds, etc.). The time intervals may be specified by
a user via any input devices (e.g., temperature controller, system
interface and/or communications device input devices (e.g., buttons,
keys, etc.), remote or local computer, etc.). The display, report
and/or information may alternatively be stored in a local or remote
database or memory device (e.g., local memory, removable memory,
etc.) for later retrieval. The displays and reports may include
a pre-arranged format or may be programmable or selected by a user
via temperature controller, system interface and/or communications
device input devices. The information displayed may be selected
via temperature controller, system interface and/or communications
device input devices, or the display may include display controls
(e.g., buttons, keys, etc.).
The external printer may be implemented by any conventional or
other printing device, may be local or remote, may serve any quantity
of systems or other devices, and may produce displays and/or reports
on any desired medium (e.g., paper, labels, etc.). The displays
and reports may be printed and/or displayed concurrently with system
operation as display and report data is collected or at any specific
time or in response to user entered information (e.g., a print command
or key). The display and/or report may be printed at any desired
time before, during or after system use. The system and/or information
device may download or transfer information to any desired device
(e.g., PDA, computer, another system, etc.) at any specific time
or in response to user entered information (e.g., transmit command
or key). The system may further be networked to enable retrieval
of information from a station coupled to the network. The printer
and displays may be disposed at any suitable locations on or remote
from the system. Alternatively, the system may be implemented to
generate displays and/or reports without the printer and/or display.
Any desired information may be transmitted between the system components
(e.g., temperature controller, system and computer interfaces, communications
device, information device, computer and server systems, printer,
displays, etc.) via any conventional or other medium or protocols
(e.g., hardwire, wireless, network, etc.).
The computer systems and server systems may be implemented by any
type of personal or other computer or processing system having any
suitable platform or operating system. The computer system may include
any commercially available operating system (e.g., Windows, OS/2,
Unix, Linux, DOS, etc.), any commercially available and/or custom
software (e.g., communications software, display and/or report generation
software, etc.) and any types of input devices (e.g., keyboard,
mouse, microphone, voice recognition, etc.). The information stores
may be implemented by any conventional database or other storage
structures (e.g., files, data structures, tables, etc.) or devices
and may include information stored in any number of files using
any file format.
Software for the system devices (e.g., temperature controller,
system interface, communications device, etc.) may be implemented
in any desired computer language and could be developed by one of
ordinary skill in the computer arts based on the functional descriptions
contained herein and the flow charts illustrated in the drawings.
The temperature controller, system interface and/or communications
device may alternatively be implemented by any type of hardware
and/or other processing circuitry, and may be available pre-programmed
for immediate use. The various functions of the temperature controller,
system interface, computer interface and communications device may
be distributed in any manner among any quantity of software or hardware
modules, computer systems, processors and/or circuitry. Further,
any references herein of software performing various functions generally
refer to computer systems or processors performing those functions
under software control. The computer system may alternatively be
implemented by hardware or other processing circuitry. The various
functions of the present invention usage control may be distributed
in any manner among any quantity (e.g., one or more) of hardware
and/or software modules or units, computer or processing systems
or circuitry, where the computer or processing systems may be disposed
locally or remotely of each other and communicate via any suitable
communications medium (e.g., LAN, WAN, Intranet, Internet, hardwire,
modem connection, wireless, etc.). The software and/or processes
described above and illustrated in the flow charts and diagrams
may be modified in any manner that accomplishes the functions described
herein.
Thermal treatment system 100 may be a stand-alone system or may
be coupled to any number of workstation computers, server computers
or data storage devices via any communications medium (e.g., network,
modem, direct connection, etc.). Authorized use and control parameters
can be transferred via a communications network or via transportable
storage devices (e.g., floppy disk, CD ROM, DVD, zip drive disk,
etc.).
Software used to access and display medical item thermal treatment
system information bases may be installed upon local or remote devices
and executed on a computer system in any conventional or other manner
(e.g., an install program, copying files, entering an execute command,
etc.). The functions associated with the present invention (e.g.,
storing/retrieving monitored information, updating authorized use
and/or control parameters, etc.) may be performed on any quantity
of computers or other processing systems. Further, the specific
functions may be assigned to one or more of the computer systems
in any desired fashion.
A user may interact with the medical item thermal treatment system
and information device (e.g., related monitored/logged data, authorized
use and control parameters, etc.) via any style of user interface
(e.g., a command line interface, a menu, a database interface, graphical
user interface, web site, etc.) on a local or remote computer or
server system. The user interface may include any desired information
arranged in any format or fashion. Access for information retrieval
and/or processing may be controlled by any conventional or other
techniques (e.g., accounts, subscriptions, passwords, identifications,
etc.). Interfaces used can be commercially available interfaces
or developed especially for use in connection with a medical item
thermal treatment system and/or medical item thermal treatment system
information base.
Thermal treatment system 100 can be implemented by any number of
controllers, modules and/or units and is not limited to the architecture
described above. Payment for use of the medical item thermal treatment
system may be arranged in any fashion (e.g., telephone transaction,
electronic transaction, billings by mail, online via a website or
local or remote computer or server system, etc.) with a service
provider or other party.
Temperature control system 700 and corresponding components may
be of any size or shape and may be constructed of any suitable materials.
The controller, fuses, power switches and labels may be disposed
on the system at any suitable locations. The system may include
any quantity of each component, while the components (e.g., cabinet,
circuitry, drawers, etc.) may be arranged in any fashion. The temperature
control system may include any quantity (e.g., at least one) of
drawers with each drawer having any quantity (e.g., at least one)
of sub-compartments. The drawers may be of any size or shape and
may be constructed of any suitable materials. The drawers may include
any conventional or other handle disposed at any location, and may
include any conventional or other pivoting or sliding mechanisms
to facilitate placement and removal of drawers and items within
the systems. The drawer sub-compartments may be of any quantity,
size or shape, while the drawers and sub-compartments may each contain
any quantity of any types of medical items. The drawers may include
a window of any shape or size, or be implemented without a window.
The window may include any type of transparent or translucent material,
and may be defined at any suitable locations on the drawer, door
or cabinet. Further, the drawers may be implemented by any types
of drawers that are capable of being placed and removed within the
system (e.g., substantially horizontal drawers, such as those in
common desks), while the system may include any quantity or combination
of different types of drawers. Moreover, the drawers, sub-compartments
or other receptacles may be disposed within the cabinet interior
chambers on shelves or other structures for receiving the medical
items.
The temperature sensor of system 700 may be implemented by any
conventional resistive or other type of temperature sensing device,
and may be disposed at any location on the drawer or cabinet interior.
The heating element may include any type of configuration covering
the entirety or a portion of the drawer bottom wall (e.g., strips,
bars, segments, include various openings, etc.). The heating element
may be implemented by any quantity of conventional or other types
of heating devices (e.g., heating coils, conduction, convection,
microwave or other radiation, etc.), and may be disposed on the
drawer at any locations. The heating element may include any type
of conventional or other connector to facilitate heating element
connections, and may be fastened to the drawer via any conventional
or other fastening techniques (e.g., adhesives, brackets, etc.).
The control circuit components (e.g., power switch, relays, fuses,
controller, power source, connection terminal, etc.) of system 700
may be implemented by any quantity of any conventional or other
electrical components arranged in any fashion and performing the
functions described above. The circuits may be disposed at any location
on or within the housings and may be arranged in any fashion to
control heating of the drawers as described above. The relays may
be implemented by any conventional solid state or other type of
relay device. Similarly, the cut-out switch may be implemented by
any conventional or other type of switching or power-limiting device.
The fuses may be implemented by any conventional or other fuses
or limiting devices configured for any desired current level, while
the power switch may be implemented by any conventional or other
switching devices (e.g., momentary, button, etc.) The system may
include any quantity of controllers, each controlling any quantity
of drawers and accommodating any quantity of set points. The controllers
may each be implemented by any conventional or other microprocessor
or controller. Software for the controller may be implemented in
any desired computer language and could be developed by one of ordinary
skill in the computer arts based on the functional descriptions
contained herein. The controller may alternatively be implemented
by any type of hardware, software and/or other processing circuitry,
and may be available pre-programmed for immediate use. The various
functions of the controller may be distributed in any manner among
any quantity of software modules, processors and/or circuitry. The
algorithms and/or processes described above may be modified in any
manner that accomplishes the functions described herein.
An intravenous pole and/or other equipment may be disposed at any
locations on the temperature control system. The pole and/or equipment
may include any quantity of temperature control systems attached
to the pole and/or equipment.
The temperature sensing strip may be implemented by any conventional
or other types of temperature strips. The temperature sensing strip
may be of any shape or size, may sense and/or display any desired
temperatures in any temperature scale (e.g., Fahrenheit, Celsius,
etc.), and may include any type of indicators (e.g., alphanumeric
or other characters) arranged in any fashion and representing any
temperature intervals or other information for any desired temperature
range. The temperature strip may utilize any color scheme to illuminate
the indicators or to indicate whether or not the solution temperature
is within particular ranges (e.g., above, within, or below a particular
temperature range). Any quantity of temperature strips may be disposed
on, attached to or formed integral with the system at any location
having sufficient proximity to the item being measured via any conventional
or other fastening techniques. The system may be implemented with
or without the temperature sensing strips and/or labels.
The temperature sensing device may alternatively be implemented
by any type of temperature measuring device (e.g., preferably those
capable of measuring temperature without directly contacting container
contents) and/or display. For example, the temperature sensing device
may be implemented by a temperature sensor in combination with a
liquid crystal (LCD) or other display to measure and display item
temperature. This mechanism may include a battery and operate on
direct current (DC) voltage, and/or include a power cord for connection
to a common wall outlet jack and utilize alternating current (AC).
Further, the temperature sensing device may be implemented by a
temperature sensor and a voice or speech synthesizer to indicate
temperature or to specify that an item is below or exceeds a predetermined
temperature (e.g., provide an audio indication, such as "too
hot", "too cold", etc.). Moreover, the temperature
sensing device may employ an analog or infrared temperature sensor,
or devices measuring temperature via sound, ultra-sonic or other
waves, and convey that temperature in any of the manners described
above.
The timer switch of system 700 may be implemented by any quantity
of any type of pressure or other switch and/or switch/sensor combination
for detecting the presence of a medical solution container or other
item and actuating or disabling a circuit. The timer switch may
include any types of mechanical, electrical and/or chemical switching
mechanisms or any combinations thereof. The timer switch may be
positioned at any location within the system or sub-compartment
to detect the presence of a medical solution container or other
item.
System 700 may be used at any suitable locations (e.g., hospital
or other medical facility, emergency medical or other vehicles,
etc.) with any types of power sources (e.g., AC, DC, wall outlet
jack, batteries, vehicle power system, etc.) to heat any quantity
of any type of medical solution container or other item. The system
may be mounted on or supported by any type of support structure
(e.g., wall, cart, table, floor, stand, etc.) via any conventional
or other fastening mechanisms (e.g., brackets, hooks, welded, integral
with system, etc.).
The timer of system 700 may be implemented by any conventional
or other timing or timer devices (e.g., processors, hardware or
other circuitry and/or software, etc.). The timer may be disposed
at any suitable locations on or in proximity to the system. The
timer may include any type of conventional or other display (e.g.,
LED, LCD, monitor, etc.) integral with or remote from the timer
or system.
The timer of system 700 may be initiated by the timer switch and/or
manually by a user via control or input devices (e.g., keys, buttons,
etc.). The timer may increment or decrement time to measure elapsed
time and may measure and/or display the time in any desired format
or time units (e.g., hours, minutes, seconds, etc.). The timer or
system may further include visual or audio alarms to notify a user
when a particular time interval expired, or disable heating upon
expiration of that time interval. Further, the timer may be combined
with or implemented by the system controller. The timer reset line
may perform a reset based on any type of signal (e.g., high or low).
The reset typically causes the display to display an initial value,
preferably zero, however the initial value may be set to any desired
time or value. The system may include any quantity of timers, where
the timers may each be associated with any quantity of sub-compartments
and/or measure and/or display various time intervals (e.g., timer
to measure residence time within the system or drawer, timer to
measure residence time within a sub-compartment, etc.).
The reset relay may be implemented by any conventional or other
relays or circuitry. The reset relay may provide any signal to the
timer to facilitate a reset. The power source may be implemented
by any conventional or other power source or circuitry and may provide
any desired power signal (e.g., 12V DC, AC, voltage, current, etc.).
System 700 may store residence time or any other information (e.g.,
temperature, etc.) in memory in order to recover and maintain residence
time measurements and/or heating in the event of a power failure
or other interruption of power (e.g., power off, etc.). The system
may further detect the temperature of a newly placed item prior
to commencing heating. If the item has a temperature above a threshold
indicating the item has been previously warmed, heating may be disabled
and/or a user may be notified of the prior warming and/or that the
residence time does not include the prior warming.
The sub-compartments and timers may include any identifiers (e.g.,
symbols, characters, numbers, etc.) to associate a sub-compartment
with a corresponding timer. The sub-compartments and/or drawers
may be individually controlled to heat corresponding medical items
to the same or different desired temperatures.
The housings and housing components of systems 800, 900 (e.g.,
panels, walls, etc.) may be of any size, shape or configuration
and may be constructed of any suitable materials including, but
not limited to, electrogalvanized steel. The housing components
may be connected via any conventional fastening techniques (e.g.,
welding, nuts and bolts, etc.). Any portion of the housings may
be constructed of a transparent material. The heating, storage and
housing compartments may be of any quantity, shape or size and may
hold any quantity of medical solution containers or other items
(e.g., one or more containers or items). The doors may be of any
quantity, shape or size, may be constructed of any suitable materials,
and may be connected to the housings at any suitable locations in
any fashion to pivot in any desired direction and/or manner (e.g.
hinged doors, sliding doors, removable panel doors, etc.). The top
wall or doors may be connected to the housing at any suitable locations
in any fashion to pivot in any desired direction and/or manner (e.g.
hinged doors, sliding doors, removable panel doors, etc.). Further,
the doors and top wall may include a window of any size or shape,
while the doors, top wall and/or window may be constructed of any
translucent, transparent or other materials. The doors and top wall
may include any quantity of any type of handle or latching mechanism
disposed at any suitable locations. The housing open portions may
be of any shape or size and may be disposed at any suitable locations.
The housings may include any types of openings, mechanisms, devices
or other techniques to provide access to the housing interior.
Systems 800, 900 may warm any quantity of any type of medical solution
container or other item to any desired temperature. The controllers
of these systems may be implemented by any conventional or other
microprocessor or controller. Software for the controllers may be
implemented in any desired computer language and could be developed
by one of ordinary skill in the computer arts based on the functional
descriptions contained herein. The controllers may alternatively
be implemented by any type of hardware, software and/or other processing
circuitry, and may be available pre-programmed for immediate use.
The various functions of the controllers may be distributed in any
manner among any quantity of software modules, processors and/or
circuitry. The algorithms and/or processes described above may be
modified in any manner that accomplishes the functions described
herein.
The controllers may be disposed on or within the systems at any
suitable locations. The controllers may control the heater to any
desired temperature. The controllers or systems may include any
quantity of any type of input device (e.g., keys, buttons, mouse,
voice, touch screen, etc.) to facilitate entry of any desired temperatures
or any other information. The controllers may include or control
any quantity of any type of display of any shape or size to convey
any desired information. The display may be integral with or detached
from the controllers or systems and may include an LED, LCD or monitor
type display, indicator lights, or any other mechanism for indicating
desired and/or measured temperature or any other information. Further,
the display may include any type of buttons or data entry devices
to program the controller in any manner. The controllers may employ
any conventional or other control algorithms (e.g., fuzzy logic,
PID, etc.). The systems may include any quantity of controllers
to accommodate any quantity of heating assemblies, or a single controller
may accommodate plural heating assemblies.
The heating plate may be of any quantity, shape, size or configuration
to heat a medical solution or other item. The heating plate may
include any quantity of conducting and/or non-conducting walls of
any shape or size and may be constructed of any suitable materials.
The heater of systems 800, 900 may be implemented by any quantity
of any conventional heater or other heating device (e.g., conduction,
convection, microwave or other radiation, etc.). The heating plate
may include any quantity of heaters of any shape or size arranged
in any configuration (e.g., strips, annular, segments, etc.) and
disposed at any suitable locations for applying heat. The heater
may be attached to the heating plate via any conventional or other
fastening technique (e.g., pressure sensitive or other adhesives,
etc.). The systems may alternatively include any quantity of heaters
of any shape or size disposed at any suitable locations on the heating
plate or within the systems.
The temperature sensors of systems 800, 900 may be implemented
by any quantity of any type of conventional or other temperature
measuring device (e.g., RTD, infrared, etc.) and may be disposed
at any suitable locations on the arm, heating plate or within the
systems. The cut-out switch may be implemented by any quantity of
any type of conventional or other limiting device and may be utilized
for any desired temperature or threshold. The cut-out switch may
be utilized in combination with the additional temperature sensor
to facilitate disablement of the heater in response to any desired
temperature or temperature range. The cut-out switch and/or additional
sensor may be disposed at any locations on the arm, heating plate
or within the systems and may measure the temperature of any system
objects (e.g., heating plate, medical item, heater, etc.). Alternatively,
a single temperature sensor may be employed to facilitate control
of the heater in response to measured medical item and excessive
heater temperatures.
The limit switch of systems 800, 900 may be implemented by any
quantity of any type of pressure or other switch and/or switch/sensor
combination for detecting the presence of a medical solution container
or other item and actuating or disabling a circuit. The limit switch
may include any types of mechanical, electrical and/or chemical
switching mechanisms or any combinations thereof. The limit switch
may be positioned at any location proximate the heating plate or
within the systems to detect the presence of a medical solution
container or other item. The limit switch components (e.g., housing,
arm, support member, contact member, etc.) may be of any shape or
size and may be constructed of any suitable materials. The arm may
support any quantity of any types of sensing devices. The switching
circuitry may include any conventional or other circuitry or mechanical
and/or electrical components that accommodate the contact member
to establish or remove a circuit connection (e.g., open or close
a circuit).
The control circuits of systems 800, 900 may utilize any conventional
or other connectors or wiring to transfer power and other signals
to system components. Further, the components of the control circuits
(e.g., power switch, relay, fuses, controllers, boards, power sources,
back light, connection terminal, etc.) may be implemented by any
quantity of any conventional or other electrical components arranged
in any fashion and performing the functions described above. The
circuits may be disposed at any location on or within the housings
and may be arranged in any fashion. The fuses may be implemented
by any conventional or other fuses or limiting devices configured
for any desired current level. The power switch, controllers, displays,
input devices and indicators may be disposed at any suitable locations
on or within the housings.
Systems 800, 900 may be used at any suitable locations (e.g., hospital
or other medical facility, emergency medical or other vehicles,
etc.) with any types of power sources (e.g., AC, DC, wall outlet
jack, batteries, vehicle power system, etc.) to heat any quantity
of any type of medical solution container or other item. The systems
preferably heat items to desired temperatures within the approximate
range of 80.degree. F. -150.degree. F., but may be utilized to heat
the items to any desired temperatures or temperature ranges.
Systems 800, 900 may be mounted on or supported by any type of
support structure (e.g., wall, cart, table, floor, stand, etc.).
The stand may be of any type, shape or size, may be constructed
of any suitable materials and may be utilized with any of the above-described
systems. The stand may be connected to the systems at any desired
locations via any conventional or other fastening mechanisms (e.g.,
brackets, hooks, welded, integral with system, etc.). The stand
components (e.g., hub, post, legs, etc.) may be of any quantity,
shape or size, may be constructed of any suitable materials and
may be arranged in any desired fashion. The stand may include any
quantity of any type of wheels or rollers disposed at any suitable
locations to facilitate transport of the system.
The storage compartment and door window may be of any shape or
size and may be disposed at any suitable locations. The window may
be constructed of any suitable materials (e.g., glass, plastic,
etc.) and include any desired degree of transparency.
The timer of systems 800, 900 may be implemented by any conventional
or other timing or timer devices (e.g., processors, hardware or
other circuitry and/or software, etc.). The timer may be utilized
with any of the above-described systems and may be disposed at any
suitable locations on or in proximity to the systems. The timer
may include any type of conventional or other display (e.g., LED,
LCD, etc.) integral with or remote from the timer or systems. The
timer or heat controller may be initiated by the limit switch and/or
manually by a user via control or input devices (e.g., keys, buttons,
etc.) to initiate time measurement. The timer or heat controller
may increment or decrement time to measure elapsed time and may
measure and/or display the time in any desired format or time units
(e.g., hours, minutes, seconds, etc.). The systems may further include
visual or audio alarms to notify a user when a particular time interval
expired, or disable heating upon expiration of that time interval.
Further, a timer may be combined with or implemented by any of the
above-described controllers. The timer reset line may perform a
reset based on any type of signal (e.g., high or low). A time reset
typically causes the timer or other display to display an initial
value, preferably zero, however the initial value may be set to
any desired time or value. Further, a time reset may facilitate
display of any type of indicator (e.g., reload or empty indication,
etc.) The systems may include any quantity of timers or controllers
to measure and/or display various time intervals (e.g., timer to
measure residence time within the system or storage compartment,
timer to measure residence time on heating plate, etc.).
The various relays (e.g., time delay, reset, etc.) may be implemented
by any conventional or other relays or circuitry. The reset relay
may provide any signal to the timer to facilitate a reset. The time
delay reset or heat controller may be set to provide any desired
time delay in any desired time units (e.g., minutes, seconds, etc.).
The power sources may be implemented by any conventional or other
power sources or circuitry and may provide any desired power signal
(e.g., 12V DC, AC, voltage, current, etc.).
The guides may be of any quantity, shape or size, and may be constructed
of any suitable materials (e.g., foam, plastic, etc.). The guides
may be disposed in the system in any quantity and in any desired
fashion. The guide components (e.g., leg, foot, etc.) may be of
any shape or size and may be connected in any fashion (e.g., at
any desired angle, etc.). The guides may be configured in any fashion
(e.g., without legs) for use with the systems described above (e.g.,
with or without a storage compartment) to align the medical item.
The trays may be of any quantity, shape or size, and may be constructed
of any suitable materials. The trays may be oriented at any desired
angle and may be mounted within the system housing in any desired
fashion via any conventional or other mounting mechanisms (e.g.,
rails, brackets, ledges, etc.). System 900 may include any quantity
of trays, with each tray including any quantity of heating assemblies.
The trays may include any quantity of dividers, where the dividers
may be of any shape or size. The heating assemblies may be placed
adjacent each other on a tray without dividers. Alternatively, any
quantity of heating plates may be formed within a continuous sheet
of heat conducting material.
The system controller may directly control any quantity of heating
assemblies without use of the heat controllers. The system controller
may further communicate in any fashion with the heat controllers
via any suitable protocols. The system controller may receive any
desired information from a user, transfer any desired information
to the heat controllers and may utilize any quantity of any type
of indicators (e.g., visual, audio, LEDs, display, etc.) to indicate
system conditions (e.g., power on, attainment of set point temperature,
etc.). The display may display any information arranged in any fashion.
The heating assemblies may include any identifiers (e.g., symbols,
characters, numbers, etc.) to associate a heating assembly with
displayed information.
The heat controllers may control any quantity of heating assemblies
and may transfer and receive any desired information from the system
controller. The heat controllers may store residence time or any
other information (e.g., temperature, etc.) in memory in order to
recover and maintain residence time measurements and/or heating
in the event of a power failure or other interruption of power (e.g.,
power off, etc.). The heat controllers may further detect the temperature
of a newly placed item prior to commencing heating. If the item
has a temperature above a threshold indicating the item has been
previously warmed, heating may be disabled and/or a user may be
notified of the prior warming and/or that the residence time does
not include the prior warming. The heat controllers may detect any
conditions and provide the information to the system controller.
The heat controller may illuminate the assembly indicator when the
item temperature is within any desired range of the set point temperature.
The assembly indicator may be disposed at any location on the heating
assembly, housing or tray and may be implemented by any visual (LED,
etc.) or audio device. The heat controllers may communicate with
the system controller synchronously or asynchronously and at any
desired time or time intervals. The functions of the system and
heat controllers may be distributed in any fashion among those controllers
(e.g., the system may operate without one of those controllers).
The heating assemblies may be individually controlled to heat corresponding
medical items to the same or different desired temperatures.
Systems 800, 900 and/or the limit switch may be responsive to a
particular weight of or pressure exerted by a medical item (e.g.,
to initiate heating, residence time measurements, etc.). For example,
the limit switch may enter a closed state in response to a medical
item having at least a desired weight or exerting at least a certain
pressure against the switch. This enables the system to accommodate
and discriminate between particular medical items (e.g., a system
for heating three liter medical solution bags does not operate for
one liter medical solution bags).
The marking device may be powered by any conventional or other
power source (e.g., AC, DC, wall outlet jack, batteries, etc.).
The marking device may be of any quantity, may be implemented by
any conventional or other marking device and may be utilized in
combination with any quantity of thermal treatment or other systems.
The marking device may be implemented as a stand-alone device or
may be attached to or integral with the thermal treatment or other
system. The marking device is preferably disposed within the proximity
of the thermal treatment or other system, but may be disposed in
any fashion relative to that system.
The marking device housing may be of any shape or size and may
be constructed of any suitable materials. The marking device may
be securable (either alone or in combination with the thermal treatment
or other system) to any type of support structure (e.g., wall, pole,
stand, etc.) via any conventional or other securing techniques (e.g.,
brackets, etc.). The marking device components (e.g., processor,
switch, display, input devices, printing unit, etc.) may be disposed
and arranged on and/or in the housing in any desired fashion. The
marking area may be disposed at any location on the housing and
may be of any shape or size to accommodate marking of any desired
items.
The marking device switch may be disposed in the marking area or
at any other locations suitable to engage the item and initiate
marking. The marking device processor may be implemented by any
quantity of any conventional or other microprocessor or controller
(e.g., chip, card, processor, circuitry, etc.). The marking device
may include any quantity of any desired input devices (e.g., buttons,
keypad, voice recognition, touch screen, etc.) disposed at any locations.
The marking device may employ any type of conventional or other
sensor or switch to indicate the presence of an item for marking.
Alternatively, the marking device may include a marking key or button
for manual control of marking by a user (e.g., the key is actuated
by a user in response to proper positioning of the item for marking).
The marking device may mark any types of medical or other items
(e.g., solution containers or bags, cassettes, lines, labels, instruments,
fabrics, cards, materials, paper products, etc.) at any locations
on the items. The items may be transported or presented to the marking
device by a user for marking. Alternatively, the marking device
may store items therein and provide to a user an item with time
stamp information. For example, the marking device may store blank
labels or labels pre-printed with descriptive information. When
a user actuates a marking device key or button, the marking device
retrieves a stored label and places the time stamp information thereon.
The label with time stamp information is provided to the user for
attachment to a medical item.
The marking device may maintain and/or provide any desired information
for placement on an item (e.g., start date and time of solution
or other item heating/cooling, the time interval the solution or
other item was heated/cooled, the temperature the solution or other
item attained during heating/cooling, temperature of the solution
or other item when the solution was removed from the system, amount
or quantity of solution or other item residing, placed in or removed
from the system, partial or complete history of time and solution
or other item temperature measured at any desired time intervals,
facility information, patient information, doctor information, type
of procedure, solution information, type of instruments or other
item being heated/cooled, amount or quantity of solution or other
item being heated/cooled, etc.) from any desired sources (e.g.,
thermal treatment system, user, memory device, another computer
or device, etc.). The processor may maintain the time stamp information
internally or utilize any desired external circuitry (e.g., a timer,
memory, etc.). The marking device may further maintain the time
stamp information provided to articles to provide a report of medical
item or procedure activity for any desired time interval.
The time stamp information may be arranged in any fashion and include
any desired information. The date, time and other information may
be in any desired format (e.g., month, day and year, hours and minutes,
text, numeric, icons, etc.). The time stamp information may be arranged
and/or presented (e.g., printed, displayed, etc.) in any desired
formats and in any order or arrangement. The time stamp information
may alternatively be stored in a local or remote database or memory
device (e.g., local memory, removable memory, etc.) for later retrieval.
The printed or marked time stamp information may include a pre-arranged
format or may be programmable or selected by a user via marking
device input devices. The time stamp information may be placed at
any suitable location on an item. The marking device display may
be of any quantity, shape or size, may be disposed at any location
on or remote from the marking device, may be implemented by any
conventional or other displays (e.g., LED, LCD, etc.) and may display
any desired information. The information displayed may be selected
via marking device input devices, or the display may include display
controls (e.g., buttons, keys, etc.).
The marking device printing unit may be implemented by any conventional
or other printing or impression device and may transfer the time
stamp information on any desired medium (e.g., paper, labels, medical
items, etc.). The time stamp information may be placed directly
on the article (e.g., item or label) via any conventional or other
techniques (e.g., a physical impression on the article (with or
without ink), a printed indicator by dot matrix, laser printing
or thermal techniques, etc.). The marking device and thermal treatment
system may include any conventional or other communications device
or module (e.g., modem, etc.) to communicate with each other or
other devices. For example, placement of time stamp information
on a medical item may enable the marking device to communicate with
the thermal treatment system to start and/or cease operation. Further,
the marking device may download or transfer an electronic form of
the time stamp information to any desired device (e.g., PDA, computer,
another marking device, thermal treatment system, etc.) at any specific
time or in response to user entered information (e.g., transmit
command or key). The marking device may further be networked to
enable retrieval of information from a station or other devices
(e.g., thermal treatment system, another marking device, etc.) coupled
to the network. Any desired information may be transmitted between
the marking device components (e.g., processor, switch, display,
input devices, printing unit, etc.) via any conventional or other
communications medium or protocols (e.g., hardwire, wireless, network,
etc.).
The label for the time stamp information may be of any size or
shape and may be of any type of printing material (e.g., paper,
thermal paper, fabric, etc.). The label may include any quantity
of areas or fields at any suitable locations to receive specific
time stamp information from the marking device (e.g., entry time
into the thermal treatment system, removal time, date, facility
name, type of solution, etc.). The fields may include any type of
descriptive information. Alternatively, the labels may be blank,
where the marking device provides the time stamp and descriptive
information. The descriptive information may be provided pre-printed
on the label or by the marking device in any combination.
The labels may be adhered to the medical item at any suitable locations
via any conventional or other techniques (e.g., adhesive, fastener,
self-adhesive label, etc.). The label adhesive may be sufficiently
strong to prevent removal of the label from the bag and/or label
tampering, or the strength of the label adhesive may enable a user
to remove the label from the bag for attachment to other items (e.g.,
patient or other chart or record, etc.). Alternatively, the medical
item may include the label already attached and be presented to
the marking device to receive the time stamp information. In addition,
the medical item may include any descriptive information and/or
fields and may directly receive the time stamp information from
the marking device (e.g., via printing or impression techniques)
at any desired locations.
The label may be any type of label enabling any quantity of time
stamp information to be placed thereon. Further, the label may include
or be partitioned into any quantity of individual sections, each
of which may receive time stamp information at different instances
and may be individually adhesive. For example, a label may include
or be partitioned into two sections. The label is presented to or
supplied by the marking device, where a first section receives time
stamp information pertaining to insertion of a medical item into
a thermal treatment system. The label is adhered to a medical item
(e.g., with the first section adhering to the medical item and the
second section in a non-adhering state) prior to insertion of the
medical item into the thermal treatment system. When the medical
item is removed from the thermal treatment system, the medical item
is transported to the marking device to enable the second section
of the label (e.g., which is not adhered to the medical item) to
be presented to the marking device to receive time stamp information
pertaining to removal of the medical item from the thermal treatment
system. The second label section is subsequently placed in an adhering
state for adherence to the medical item.
Software for the marking device processor may be implemented in
any desired computer language and could be developed by one of ordinary
skill in the computer arts based on the functional descriptions
contained herein. The processor may alternatively be implemented
by any type of hardware and/or other processing circuitry, and may
be available pre-programmed for immediate use. The various functions
of the processor may be distributed in any manner among any quantity
of software modules, processors and/or circuitry. The algorithms
and/or processes described above may be modified in any manner that
accomplishes the functions described herein. Further, an item may
be marked any quantity of times with time stamp information at any
instances to provide a history of item activity and may include
any quantity of labels. Moreover, an item may include time stamp
information placed directly on the item, placed on a label adhered
to the item, or placed on the item and label in any combination.
The thermal treatment systems described above may be used at any
suitable locations (e.g., hospital or other medical facility, emergency
medical or other vehicles, etc.) with any types of power sources
(e.g., AC, DC, wall outlet jack, batteries, vehicle power system,
etc.) to thermally treat any quantity of any type of medical solution
container or other item. The systems preferably heat items to desired
temperatures within the approximate range of 80.degree. F.-150.degree.
F., but may be utilized to heat and/or cool the items to any desired
temperatures or temperature ranges.
It is to be understood that the terms "top", "bottom",
"front", "rear", "side", "height",
"width", "length", "upper", "lower"
and the like are used herein merely to describe points of reference
and do not limit the present invention to any particular configuration
or orientation.
From the foregoing description, it will be appreciated that the
invention makes available novel medical item thermal treatment systems
and method of monitoring medical items for compliance with prescribed
requirements, wherein medical items may be monitored for compliance
with prescribed requirements from item manufacture through item
use and/or disposal.
Having described preferred embodiments of new and improved medical
item thermal treatment systems and method of monitoring medical
items for compliance with prescribed requirements, it is believed
that other modifications, variations and changes will be suggested
to those skilled in the art in view of the teachings set forth herein.
It is therefore to be understood that all such variations, modifications
and changes are believed to fall within the scope of the present
invention as defined by the appended claims.
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