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Medical Patent Abstract
A non-compliant medical balloon may be changed from a deflated state
to an inflated state by increasing pressure within the balloon.
The non-compliant medical balloon is composed of a woven fabric
layer composed of at least two woven fabric fibers forming an angle.
The angle remains substantially unchanged when the balloon changes
from a deflated state to an inflated state.
Medical Patent Claims
What is claimed is:
1. A non-compliant medical balloon, where the non-compliant medical
balloon may be changed from a deflated state having a folded configuration
to an inflated state having a smooth, unfolded configuration by
increasing pressure within the balloon, comprising: an inner wall
formed of a flexible but substantially inelastic polymer material
defining two spaced-apart cone portions and a barrel portion disposed
therebetween; an adhesive layer applied directly to the outer surface
of the inner wall; a woven fabric layer including at least one substantially
inelastic fabric fiber interwoven with a second fabric fiber in
a single fabric layer, wherein said first fabric fiber and said
second fabric fiber define angles where they cross one another;
wherein the balloon can change between a deflated state having a
folded configuration with balloon folds on the outer surface to
an inflated state having an unfolded configuration with a substantially
smooth outer surface by increasing the pressure within the inner
wall; and wherein the fibers of the woven fabric layer are affixed
to the inner wall by the adhesive layer such that the angles between
the first fabric fiber and the second fabric fiber remains substantially
unchanged when the balloon changes from the deflated state to the
inflated state.
2. The non-compliant medical balloon of claim 1, further comprising
a binding layer on an outer surface of said woven fabric layer.
3. The non-compliant medical balloon of claim 2, wherein said fabric
layer further includes a polymeric coating.
4. The non-compliant medical balloon of claim 2, wherein said binding
layer is a polymeric coating.
5. The non-compliant medical balloon of claim 4, wherein said polymeric
coating is formed of a polymer.
6. The non-compliant medical balloon of claim 4, wherein said polymeric
coating is formed of a copolymer.
7. The non-compliant medical balloon of claim 1, further comprising
a second fiber layer on said woven fabric layer.
8. The non-compliant medical balloon of claim 7, wherein said second
fiber layer comprises a plurality of parallel hoop fibers.
9. The non-compliant medical balloon of claim 8, wherein said hoop
fiber is substantially transverse to the longitudinal axis of the
balloon.
10. The non-compliant medical balloon of claim 8, wherein said
hoop fiber has a thickness of about 0.0005 inch.
11. The non-compliant medical balloon of claim 8, wherein said
parallel hoop fibers have a wind density of approximately 50 wraps
per inch.
12. The non-compliant medical balloon of claim 7, further comprising
a third fiber layer on said second fiber layer.
13. The non-compliant medical balloon of claim 1, wherein said
second fabric fiber is also an inelastic fiber.
14. The non-compliant medical balloon of claim 1, wherein said
angles between the fibers of the woven fabric layer are substantially
right angles.
15. The non-compliant medical balloon of claim 1, wherein said
first fabric fiber interwoven in the woven fabric layer has a thickness
of about 0.0005 inch.
16. The non-compliant medical balloon of claim 1, wherein said
angles between the fibers of the woven fabric layer are about ten
degrees.
17. A balloon catheter comprising: a catheter tube having a distal
end; and a non-compliant balloon element attached to the distal
end of said catheter tube, where the balloon element may be changed
from a deflated state having a folded configuration with balloon
folds on the outer surface to an inflated state having an unfolded
configuration with a substantially smooth, unfolded outer surface
by increasing pressure within the balloon element, and where the
balloon element includes an inner wall formed of a flexible but
substantially inelastic polymer material defining two spaced-apart
cone portions and a barrel portion disposed therebetween, an adhesive
layer applied directly to the outer surface of the inner wall, a
woven fabric layer including at least one substantially inelastic
fabric fiber interwoven with a second fabric fiber in a single fabric
layer, wherein said first fabric fiber and said second fabric fiber
define angles where they cross one another, and wherein the fibers
of the woven fabric layer are affixed to the inner wall by the adhesive
layer such that the angles between the first fabric fiber and the
second fabric fiber remain substantially unchanged when the balloon
element changes from the deflated state to the inflated state.
18. The balloon catheter of claim 17, further comprising a binding
layer on an outer surface of said woven fabric layer.
19. The balloon catheter of claim 18, wherein said fabric layer
further includes a polymeric coating.
20. The balloon catheter of claim 18, wherein said binding layer
is a polymeric coating.
21. The balloon catheter of claim 20, wherein said polymeric coating
is formed of a polymer.
22. The balloon catheter of claim 20, wherein said polymeric coating
is formed of a copolymer.
23. The balloon catheter of claim 17, further comprising a second
fiber layer on said woven fabric layer.
24. The balloon catheter of claim 23, wherein said second fiber
layer comprises a plurality of parallel hoop fibers.
25. The balloon catheter of claim 24, wherein said hoop fiber is
substantially transverse to the longitudinal axis of the balloon.
26. The balloon catheter of claim 24, wherein said hoop fiber has
a thickness of about 0.0005 inch.
27. The balloon catheter of claim 24, wherein said parallel hoop
fibers have a wind density of approximately 50 wraps per inch.
28. The balloon catheter of claim 24, further comprising a third
fiber layer on said second fiber layer.
29. The balloon catheter of claim 17, wherein said second fabric
fiber is also an inelastic fiber.
30. The balloon catheter of claim 17, wherein said angles between
the fibers of the woven fabric layer are substantially right angles.
31. The balloon catheter of claim 17, wherein said first fabric
fiber interwoven in the woven fabric layer has a thickness of about
0.0005 inch.
32. The balloon catheter of claim 17, wherein said angles between
the fibers of the woven fabric layer are about ten degrees.
33. A non-compliant medical balloon, where the balloon may be changed
from a deflated state having a folded configuration to an inflated
state having an unfolded configuration by increasing the internal
pressure, the balloon comprising: a base layer formed of a flexible
but substantially inelastic polymer material defining two spaced-apart
cone portions and a barrel portion disposed therebetween; a first
adhesive layer applied to the surface of the base layer; a first
reinforcing layer affixed to the base layer by the first adhesive
layer, the first reinforcing layer being one of either a plurality
of discrete inelastic fibers oriented substantially parallel to
the long axis of the balloon and having a length substantially equal
to the length of the long axis of the balloon and a first woven
fabric layer including at least one substantially inelastic fabric
fiber interwoven with a second fabric fiber in a single fabric layer,
the first fabric fiber and said second fabric fiber defining angles
where they cross one another; a second reinforcing layer being applied
at least partially over the first reinforcing layer, the second
reinforcing layer being one of either at least one inelastic fiber
wrapped around the circumference of the balloon substantially transverse
to the long axis of the balloon such that the circumferential inelastic
fibers are evenly distributed along the length of the long axis
of the balloon and a second woven fabric layer including at least
one substantially inelastic fabric fiber interwoven with a second
fabric fiber in a single fabric layer, the first fabric fiber and
said second fabric fiber defining angles where they cross one another;
at least one of the first and second reinforcing layers being one
of the first and second woven fabric layers; and a second adhesive
layer affixing the second reinforcing layer to the first reinforcing
layer; wherein, when the balloon is in the deflated state, the outer
surface of the balloon layer has a folded configuration of relatively
small diameter, when the balloon is in a fully inflated state, the
outer surface of the balloon layer has an unfolded configuration
with a relatively large diameter, and when the balloon is fully
inflated, it has a length and diameter that do not substantially
change as the internal pressure increases, and wherein the angles
between the first and second fibers in the first and second woven
layers, if present, remain substantially unchanged when the balloon
changes from the deflated state to the inflated state.
Medical Patent Description
TECHNICAL FIELD OF THE INVENTION
This invention is related to medical balloons, in particular non-compliant
medical balloons used with a balloon catheter in medical procedures
such as angioplasty.
BACKGROUND OF THE INVENTION
Medical balloons have been widely used in medical procedures. Typically,
an uninflated medical balloon is inserted into a body-space. When
the medical balloon is inflated, the volume of the medical balloon
expands, and the body-space is similarly expanded. In procedures
such as angioplasty, the medical balloon may be used to open a collapsed
or blocked artery.
Generally, medical balloons have been made of rubber or other compliant
substances. To inflate the compliant medical balloons, pressure
is increased within the medical balloon, causing the compliant substance
to stretch. As more and more pressure is applied to the inner surface
of the medical balloon, the medical balloon expands larger and larger
until the medical balloon bursts. A typical medical balloon will
burst at approximately 7-20 atmospheres or about 100-300 psi.
One of the principal difficulties in the use of medical balloons
in medical procedures is controlling the dimensions of the inflated
medical balloon. The pressure introduced must be sufficient to inflate
the medical balloon to the proper size, however too much pressure
may overinflate the balloon. Overinflating a medical balloon may
cause the balloon to expand to a size that may cause stress on the
body and may even damage the body. In the worst case, the excess
of pressure may burst the balloon, which can lead to serious complications.
While medical balloons are typically made to close tolerances so
that the inflation pressure of the balloon is predictable, variations
in the materials used may cause compliant medical balloons to either
under-inflate or overinflate for a given pressure. The equipment
used to inflate and control the pressure of the balloon must be
carefully calibrated and sufficiently accurate to deliver the expected
pressure with minimal deviations.
Medical balloons are commonly used in angioplasty, orthopaedics
and other medical procedures where it is necessary to force a space
within the body.
Non-compliance, or the ability not to expand beyond a predetermined
size on pressure and to maintain substantially a profile, is a desired
characteristic for balloons. A non-compliant medical balloon is
less likely to rupture or dissect the vessel as the balloon expands.
The burst pressure of a balloon is the average pressure required
to rupture a balloon; usually measured at body temperature.
Further difficulties often arise in guiding a balloon catheter
into a desired location in a patient due to the friction between
the apparatus and the vessel through which the apparatus passes.
The result of this friction may be failure of the balloon due to
abrasion and puncture during handling and use. Failure may also
result from over-inflation.
Therefore, what is needed is a non-compliant medical balloon that
can be inflated with pressure such that the balloon maintains its
inflated dimensions without further expanding when additional pressure
is applied.
SUMMARY OF THE INVENTION
A non-compliant medical balloon may be changed from a deflated
state to an inflated state by increasing pressure within the balloon.
The non-compliant medical balloon is composed of a woven fabric
layer composed of at least two woven fabric fibers forming an angle.
The angle remains substantially unchanged when the balloon changes
from a deflated state to an inflated state.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1A illustrates a semi-cross section of a fiber-reinforced
medical balloon;
FIG. 1B illustrates a deflated fiber-reinforced medical ballon;
FIG. 2 illustrates an inflated balloon base layer;
FIG. 3 illustrates a balloon-shaped mandrel;
FIG. 4 illustrates a balloon base layer having an adhesive layer;
FIG. 5 illustrates a first fiber layer;
FIG. 6 illustrates a cross-section of a balloon base layer, adhesive
layer and first fiber layer;
FIG. 7 illustrates a cross-section of a balloon base layer, adhesive
layer and first fiber layer;
FIG. 8 illustrates a cross-section of a balloon base layer, an
adhesive layer, a first fiber layer, a second fiber layer, an outer
coating layer and a final layer;
FIG. 9 illustrates a cross-section of a balloon base layer, an
adhesive layer, a first fiber layer, a second fiber layer and an
outer coating layer;
FIG. 10 illustrates a fiber-reinforced medical balloon with a longitudinal
first fiber layer and a circumferential second fiber layer;
FIG. 11 illustrates a fiber-reinforced medical balloon with a longitudinal
first fiber layer and an angled second fiber layer;
FIG. 12 illustrates a fiber-reinforced medical balloon having an
angled first fiber layer and a circumferential second fiber layer;
FIG. 13 illustrates a fiber-reinforced medical balloon having a
longitudinal first fiber layer and an angled second fiber layer;
FIG. 14 illustrates a fiber-reinforced medical balloon having an
angled first fiber layer and an angled second fiber layer;
FIG. 15 illustrates a cross-section of a balloon base layer, an
adhesive layer, a first fiber layer, a second fiber layer, a third
fiber layer and an outer coating layer;
FIG. 16 illustrates a fiber-reinforced medical balloon having a
longitudinal first fiber layer, an angled second fiber layer and
a third fiber layer;
FIG. 17A illustrates a fiber-reinforced medical balloon having
a woven fiber layer;
FIG. 17B is an enlarged illustration of a portion of the balloon
of FIG. 17A;
FIG. 18 illustrates a cross-section including a woven fiber layer;
FIG. 19 illustrates a fabric layer including taut parallel fibers;
FIG. 20 illustrates a fabric layer including matted fibers;
FIG. 21 illustrates a medical balloon having attached strengthening
rods;
FIG. 22 illustrates a cross-section of a medical balloon having
attached strengthening rods;
FIG. 23 illustrates a balloon catheter;
FIG. 24 illustrates a cross-section of a balloon catheter tube;
FIG. 25 illustrates a deflated fiber-reinforced medical balloon;
FIG. 26 illustrates a balloon catheter, connector and syringe;
FIG. 27 illustrates a balloon catheter and a pressurized fluid
delivery system;
FIG. 28 illustrates a cross-section of a blocked vessel;
FIG. 29 illustrates a cross-section of a blocked vessel containing
an inflated balloon catheter;
FIG. 30 illustrates vertebrae and a vertebral body;
FIG. 31 illustrates vertebrae treated with a balloon catheter.
DETAILED DESCRIPTION OF THE INVENTION
Referring now to the drawings, wherein like reference numbers are
used to designate like elements throughout the various views, several
embodiments of the present invention are further described. The
figures are not necessarily drawn to scale, and in some instances
the drawings have been exaggerated or simplified for illustrative
purposes only. One of ordinary skill in the art will appreciate
the many possible applications and variations of the present invention
based on the following examples of possible embodiments of the present
invention.
With reference to FIG. 1A, a cross section of an inflated fiber-reinforced
medical balloon 10 is shown. With reference to FIG. 1B, a cross
section of a deflated fiber-reinforced medical balloon 30, is shown.
The fiber-reinforced balloon, 10 and 30, is substantially non-compliant,
having limited expansion characteristics. As pressure is applied
to the interior of a deflated balloon 30 through catheter inlet
connector 34, the deflated balloon 30 inflates. Balloon folds 31
in outer surface 32 decrease the diameter of the medical balloon
30 for insertion. As the deflated medical balloon 30 inflates, the
balloon folds 31 substantially disappear until the balloon 30 reaches
an inflated size, as indicated by balloon 10 in FIG. 1A. Because
the medical balloon 10 is non-compliant, once the balloon 10 is
fully inflated, it has a length 118 and diameter 116 that do not
change as the pressure on the interior of the balloon 10 increases.
The diameter 116 of an inflated fiber-reinforced medical balloon
10 in accordance with the one embodiment may be about ten millimeters.
Balloons 10 with a diameter 116 of about five millimeters to twenty
millimeters have been developed. The length 118 of an inflated fiber-reinforced
medical balloon 10 in accordance with one embodiment may be about
eight centimeters. Balloons 10 with a length 118 of two centimeters,
three centimeters, four centimeters, six centimeters and eight centimeters
have been made. The inclination angle of the cone portion 108 of
an inflated fiber-reinforced medical balloon 10 in accordance with
the disclosed embodiment may be about twenty degrees. It will be
recognized by those having skill in the art that the fiber-reinforced
balloon 10 could be made in a wide variety of diameters 116 and
lengths 118 and with a variety of inclinations at the cone portion
108 of the balloon.
The fiber-reinforced balloon 10 is generally suitable for use as
a medical balloon. Medical balloons are commonly used in angioplasty,
orthopaedics and other medical procedures where it is necessary
to create a space within the body. It may be recognized by those
skilled in the art that the qualities of a fiber-reinforced balloon
10 may make the balloon 10 suitable for other uses. The fiber-reinforced
balloons 10 may be used non-medically to create space or otherwise.
The fiber-reinforced balloons 10 may be used in ways beyond the
present uses of medical balloons.
The fiber-reinforced medical balloon 10 may integrally include
base balloon layer 100, a first layer of thin inelastic fibers 12
made up of one or more fibers 13. The fiber-reinforced medical balloon
10 may integrally include a second layer of thin inelastic fibers
14 made up of one or more fibers 15. An outer coating layer 16 may
be integrally included in the fiber-reinforced medical balloon 10.
Each fiber 13 is typically fixed relative to other fibers in the
first fiber layer 12 and other fibers in the balloon 10. The thin
inelastic fibers 13 of the first fiber layer 12 may be characterized
by a high tensile strength. As required for medical uses, the fiber-reinforced
balloons 10 provide superior burst strength. The fiber-reinforced
balloon 10 may also resist abrasion, cuts and punctures. It may
be recognized that enhanced structural integrity may result from
the fiber reinforcement.
With reference to FIG. 2, a fiber reinforced medical balloon may
include a base layer 100. The base layer 100 may be in the shape
of a standard medical balloon, ore any other suitable shape. A standard
polymeric balloon may function as a base layer 100 for the fiber-reinforced
medical balloon 10. The base balloon layer 100 typically includes
a first passage region 102 which may be formed as a narrow cylinder
fashioned to attach to the tube of a catheter. A second passage
region 110 may be similarly formed as a narrow tube. The first passage
region 102 is formed adjacent to a first cone region 104. The first
cone region 104 expands the diameter of the first passage region
to meet the barrel region 106, marked by a first edge 114. The first
cone region 104 is typically constructed at an angle of about twelve
to twenty degrees.
The barrel region 106 is characterized by a length 118 and a diameter
116. The barrel region 106 meets the second cone region 108 at a
second edge 112. The second cone 108 meets the second passage region
110.
The base layer balloon 100 is typically formed of a thin film polymeric
material, or other suitable materials with high strength relative
to film thickness. Polymers and copolymers that can be used for
the base balloon 100 include the conventional polymers and copolymers
used in medical balloon construction, such as, but not limited to,
polyethylene, (PET), polycaprolactam, polyesters, polyethers, polyamides,
polyurethanes, polyimides, ABS, nylons, copolymers, polyester/polyether
block copolymers, ionomer resins, liquid crystal polymers, and rigid
rod polymers. The base layer balloon 100 may typically be formed
as a blow-molded balloon of highly oriented polyethylene terephthalate
(PET).
The strength of the fiber-reinforced balloons 10 permits the use
of base layer balloons 100 having a wall thickness 120 less than
conventional or prior art balloons without sacrifice of burst strength,
abrasion resistence, or puncture resistance. In accordance with
the disclosed embodiment, the base layer balloon 100 may have a
wall thickness 120 of 0.0008 inch. It will be recognized by those
skilled in the art that the wall thickness 120 of the base layer
balloon 100 may be diminished as required. Because it is possible
for a fiber-reinforced balloon 10 to omit the PET balloon base layer
100, the balloon wall thickness 120 can be selected to be arbitrarily
small.
The balloon base layer 100 may be omitted from a fiber-reinforced
balloon 10, in accordance with one embodiment. The base layer of
a polymer 100, which has been cured into the shape of a balloon
may be formed. This polymer base layer 100 forms the inner polymeric
wall of the fiber reinforced balloon. With reference to FIG. 3,
a removable mandrel 122 may be used as a base for application of
the polymer. After the polymer is cured, the mandrel 122 may be
removed by standard means such as an application of heat to destructure
the mandrel 122.
A removable base balloon may be used as the mandrel 122. The mandrel
122 may be made from a variety of materials. The mandrel 122 may
be made in the shape of the interior wall of the desired finished
balloon. The mandrel 122 may be made of collapsible metal or polymeric
bladder, foams, waxes, low-melting metal alloys, and the like. Once
the composite balloon is developed and laminated, the base balloon
or mandrel 122 may be removed by melting, dissolving, fracturing,
compressing, pressurizing or other suitable removal techniques.
In using the mandrel 122 arrangement, alternative processing techniques
can be employed which do not limit the parameters of temperature,
force, pressure, etc., during the lamentation process. The materials
used for the balloon construction are not limited to those which
conform to the present art of forming a balloon with pressure, temperature
and force, such as, for example, those utilized for forming a balloon
from a tube made from a polymeric material. Stronger fiber-reinforced
balloons 10, with higher pressure and better damage resistance,
can be formed with smaller geometries, in particular balloons having
thinner walls. The resulting fiber-reinforced balloons 10 can be
stronger, softer and more flexible. This minimizes the necessary
introducer passage while providing higher performance at higher
pressures.
With reference to FIG. 4, integral layers of the fiber-reinforced
balloon 10 are shown. In accordance a disclosed embodiment, a thin
coating of an adhesive 126 is applied to the inflated polymer balloon
base layer 100 or to the polymer-coated mandrel 122 prior to applying
the first layer inelastic fibers 12. The adhesive 126 binds the
fibers 13 sufficiently to hold them in position when the fibers
13 are placed on the base layer balloon 100. In accordance with
one embodiment, a very thin coat of 3M-75 adhesive 126 is applied
to the base layer balloon 100. 3M-75 is a tacky adhesive available
from the 3M Company, Minneapolis, Minn.
With reference to FIG. 5, integral layers of the fiber-reinforced
balloon 10 are shown. One or more fibers 13 are applied to the polymeric
base layer 100 to form a first fiber layer 12. The first fiber layer
12 may be referred to as the "primary wind."
The fibers 13 of the first fiber layer 12 may be inelastic fiber,
typically made of an inelastic fibrous material. An inelastic fiber
is a fiber that has very minimal elasticity or stretch over a given
range of pressures. Some fibrous materials are generally classified
as inelastic although the all fibrous material may have a detectable,
but minimal, elasticity or stretch at a given pressure.
The fibers 13 of the first fiber layer 12 may be high-strength
fibers, typically made of a high-strength fibrous material. Some
high strength inelastic fibrous materials may include Kevlar, Vectran,
Spectra, Dacron, Dyneema, Terlon (PBT), Zylon (PBO), Polyimide (PIM),
other ultra high molecular weight polyethylene, aramids, and the
like.
In a disclosed embodiment, the fibers 13 of the first fiber layer
12 are ribbon-shaped, where the width of the fiber is larger than
the thickness of the fiber. The fibers 13 may be flat so that the
fiber has a rectangular cross-section. The fibers 13 used in the
initial layer of fibers 12 may all be fibers 13 made of the same
material and the same shape. Fibers 13 made from different materials
may be used in the initial fiber layer 12. Fibers 13 made in different
shapes may be used in the initial fiber layer 12.
Ultra High Molecular Weight Polyethylene fiber 13, which has been
flattened on a roll mill may be used to form the first fiber layer
12. To the flattened fiber 13 is applied a thin coat of a solution
of polyurethane adhesive in a 60-40 solution of methylene chloride
and methylethylketone. The fibers 13 may be arranged as 30 longitudinal
fibers, each substantially equal in length to the length 118 of
the long axis of the balloon 100.
The fibers 13 of the initial fiber layer 12, in accordance with
the disclosed embodiment, are arranged so that each fiber 13 is
substantially parallel to the long axis of the balloon 100. Longitudinally
placed fibers 13 are fibers 13 placed along the long axis of the
balloon 100. The fibers 13 may be parallel to each other. The density
of the fibers 13 in the initial fiber layer 12 is determined by
the number of fibers 13 or fiber winds per inch and the thickness
of the fibers 13.
In a disclosed embodiment of the first fiber layer 12 having longitudinally-placed
fibers 13, a fiber density of generally about 15 to 30 fibers 13
having a fiber thickness of about 0.0005 to 0.001 inch and placed
equidistant from one another provide adequate strength for a standard-sized
fiber-reinforced medical balloon 10. Kevlar.RTM. fibers 13 may be
positioned along the length of the balloon 100 to form the first
fiber layer 12. Each of the fibers 13 is substantially equal in
length to the length 118 of the long axis of the balloon 100. Twenty-four
fibers 13 may be positioned substantially equally spaced from each
other.
The fiber 13 used for the primary wind may have a thickness of
0.0006 inch. Fiber 13 with a thickness of 0.0005 inch may be used
instead. The resulting composite balloon 10 is axially and radially
non-compliant at very high working pressures. The fiber-reinforced
balloon 10 has very high tensile strength and abrasion and puncture
resistance. High strength ultra-high molecular weight polyethylene
fiber may be used.
The first fiber layer 12 may prevent longitudinal extension of
the completed fiber-reinforced balloon 10. The longitudinally placed
fibers 13 may be parallel to or substantially parallel to the long
axis of the base layer balloon 100 for maximum longitudinal stability
of the fiber-reinforced balloon 10.
With reference to FIG. 6, a cross-section of the integral layers
of a fiber-reinforced balloon 10 is depicted. A base layer 100 is
coated with an adhesive layer 126. The first fiber layer 12 is positioned
on the base layer 100, held at least partially in place by the adhesive
layer 126.
In accordance with a disclosed embodiment, a second fiber layer
14 made with one or more high-strength inelastic fibers 15 is positioned
along circumference of the balloon 100, as shown in FIG. 7. The
circumferentially placed fibers 15 may be transverse or substantially
transverse to the long axis of the balloon 100. The circumferential
fibers 15 may prevent or minimize distension of the balloon diameter
116 at pressures between the minimal inflation pressure and the
balloon burst pressure.
The fibers 15 of the second fiber layer 14 may be inelastic fiber,
typically made of an inelastic fibrous material. An inelastic fiber
is a member of a group of fibers that have very minimal elasticity
or stretch in a given range of pressures. Some fibrous materials
are generally classified as inelastic although the all fibrous material
may have a detectable, but minimal elasticity or stretch at a given
pressure.
The fibers 15 of the second fiber layer 14 may be high-strength
fibers, typically made of a high-strength fibrous material. Some
high strength inelastic fibrous materials may include Kevlar, Vectran,
Spectra, Dacron, Dyneema, Terlon (PBT), Zylon (PBO), Polyimide (PIM),
other ultra high molecular weight polyethylene, aramids, and the
like.
In a disclosed embodiment, the fibers 15 of the second fiber layer
14 are ribbon-shaped, where the width of the fiber is larger than
the thickness of the fiber. The fibers 15 may be flat so that the
fiber has a rectangular cross-section. The fibers 15 used in the
second layer of fibers 14 may all be fibers 15 made of the same
material and the same shape. Fibers 15 made from different materials
may be used in the second fiber layer 14. Fibers 15 made in different
shapes may be used in the second fiber layer 14.
Ultra High Molecular Weight Polyethylene fiber 15, which has been
flattened on a roll mill may be used to form the second fiber layer
14. To the flattened fiber 15 is applied a thin coat of a solution
of polyurethene adhesive in a 60-40 solution of methylene chloride
and methylethylketone. The fibers 15 may be arranged as a second
fiber layer 14 may have a fiber density of 54 wraps per inch. The
fibers 15 may be coated with the adhesive solution to form the outer
coating layer 16.
The fibers 15 of the second fiber layer 14 may be perpendicular
to or substantially perpendicular to the fibers 13 placed longitudinally
to form the first fiber layer 12. This transverse placement of the
first fiber layer 12 and the second fiber layer 14 allows for maximum
radial stability of the fiber-reinforced balloon 10. The placement
of the fiber layers 12 and 14 distributes the force on the balloon
surface equally, creating pixelized pressure points of generally
equal shape, size and density.
The fibers 13 of the first fiber layer 12 may be the same as or
different from the fiber 15 of the second fiber layer 14. Specifically,
the fibers 15 of the second fiber layer 14 may be made of a different
material or materials than the fibers 13 of the first layer 12.
The fibers 15 of the second layer 14 may be shaped differently from
the fibers 13 of the first fiber layer 12. The characteristics of
the fibers or combination of fibers used for the first or second
fiber layers may be determined from the specific properties required
from the resulting fiber-reinforced balloon 10.
With respect to the fiber density of the second fiber layer 14,
in accordance with the disclosed embodiment, fiber 15 having a thickness
of about 0.0005 to 0.001 inch and arranged in parallel lines with
about 50 to 80 wraps per inch provides generally adequate strength.
A single fiber 15 may preferably form the second fiber layer 14,
with the fiber 15 wound in a generally parallel series of circumferential
continuous loops.
For a standard-sized medical balloon 10, the single fiber 15 may
be about 75-100 inches long. Kevlar.RTM. fiber 15 may be applied
radially around the circumference of and over substantially the
entire length 118 of the long axis of the balloon 100. The fiber
15 has a thickness of 0.0006 inch and is applied at a wind density
of 60 wraps per inch.
With reference to FIG. 8, a cross section of the integral layers
of a fiber-reinforced medical balloon 10 is shown. The first fiber
layer 12 and the second fiber layer 14 may be coated with an outer
coating layer 16. The outer coating layer 16 may be, in the disclosed
embodiment, a polymeric solution. The outer coating layer 16 may
be a cured polymeric solution. A fiber-wound based PET balloon 10
may be coated with a 10% solution of 5265 polyurethane in dimethylacetamide
(DMA) that has been allowed to cure at room temperature. Five additional
coatings of the polurethane solution may be used to form the outer
coating layer 16. The resulting composite fiber-reinforced balloon
10 is non-compliant and exhibits superior burst strength and abrasion
and puncture resistance. One or more additional protective layers
18 may be positioned on the outer coating layer 16, to provide additional
layers of protection.
A composite structure typically including balloon base layer 100,
an adhesive 126, a first fiber layer 12, a second fiber layer 14
and an outer coating layer 16 forms a composite, non-compliant fiber-reinforced
balloon 10 particularly suitable for medical uses. The outer coating
layer 16 of the fiber/polymeric matrix secures and bonds the fibers
13 and 15 to the underlying PET balloon base layer 100. Typically,
the relative movement of the fibers 13 and 15 are fixed when the
fiber-reinforced balloon 10 is initially deflated, and then subsequently
inflated and deflated during use.
A wax mandrel 122 may be coated with a very thin layer (0.0002
inch) of polyurethane to form a balloon base layer 100. After the
polyurethane has been cured, adhesive 126 and fibers may be applied
to form a first fiber layer 12 and a second fiber layer 14. Several
coats of polyurethane may be applied to form the outer coating layer
16. The wax mandrel 122 is then exhausted by dissolving in hot water
to form a non-compliant, very high strength, abrasion-resistant,
composite fiber-reinforced balloon 10.
A balloon-shaped solid mandrel 122 made of a low melting temperature
metal alloy may be coated with a thin layer of polyurethene/DMA
solution (10%) as an base layer 100. Fibers may be positioned to
form a first fiber layer 12 and a second fiber layer 14. The fibers
13 and 15 may be coated with a polyurethene/DMA outer coating layer
16.
A mandrel 122 may be coated with a very thin layer of PIM polyimide
(2,2-dimethylbenzidine) in solution in cyclopentanone as a base
layer 100. Polyimide fibers may be positioned to form a first fiber
layer 12 and the second fiber layer 14. The composite balloon 10
may have an outer coating layer 16 of the PIM solution. When the
mandrel 122 is removed, the fiber-reinforced balloon 10 is characterized
by a high strength and puncture resistance. The balloon 10 will
be formed with an extremely cohesive fiber/matrix composite wall
that is resistant to delamination.
With reference to FIG. 9, a cross-section of the integral layers
of a fiber-reinforced balloon 10 in accordance with one embodiment
is shown. The longitudinal first fiber layer 12 may be replaced
by a longitudinally oriented thin film 20 made of polyimide film.
The film 20 may be cut into a balloon-shaped pattern and applied
to the mandrel 122, over which the polyimide hoop fibers 14 and
the PIM solution 16 may be applied.
The thickness of the polymeric outer coating layer 16 may be determined
by the characteristics of the desired fiber-reinforced balloon 10.
The polymeric solution used for the outer coating layer 16 may be
made of the same polymer as the polymer base balloon layer 100.
The outer coating layer 16 may be made from a different polymer
than the the inflated polymeric balloon base layer 100. Where the
polymers are different, the polymers may be chosen to be compatible
to reduce or prevent separation of the composite balloon 10.
Polymers and copolymers that may be used as the outer coating layer
16 of the fiber/polymeric matrix include the conventional polymers
and copolymers used in medical balloon construction. Typical suitable
substances may include polyethylene, nylons, polyethylene terephthalate
(PET), polycaprolactam, polyesters, polyethers, polyamides, polyurethanes,
polyimides, ABS copolymers, polyester/polyether block copolymers,
ionomer resins, liquid crystal polymers, and rigid rod polymers.
A final layer 18, generally a homogeneous polymeric or other material
layer, may be positioned on the outer layer 16 as a protective layer.
The final laminate 18 may be applied as a film, a spray coating,
by dipping or other deposition process. The resulting final laminate
18 is rendered more resistant to damage of the the fibers. The final
composite improves resistance to abrasion. The added layer 18 provides
improved stent retention for deployment. The polymeric final layer
18 lowers the final durometer of the balloon surface.
While the fiber reinforced balloon 10 having a balloon base layer
100, a first fiber layer 12 and second fiber layer 14 and an outer
coating layer 16 forms the balloon 10 of the disclosed embodiment,
it will be recognized by those skilled in the art that other variations
of the embodiment may be formed. In particular, a variety of combinations
of fiber layers, fiber layer orientations and fabrics may be used
to form various medical balloons having various attributes.
With reference to FIG. 10, a fiber reinforced balloon 10 in accordance
with the disclosed embodiment, is shown. In this embodiment, the
fibers 13 of the first fiber layer 12 lie parallel to the long axis
of the balloon 10.
With reference to FIG. 11, a fiber reinforced balloon 45, in accordance
with another embodiment is shown. The fiber-reinforced balloon 45
may include a first fiber layer 46 with fibers 47 that lie at an
angle to the longitudinal axis of the balloon 45. In this embodiment,
neither the fibers 47 of the first fiber layer 46 nor the fibers
49 of the second fiber layer 48 are positioned parallel to the longitudinal
axis of the balloon 45. In accordance with one embodiment, the fibers
47 of the first fiber layer 46 may be positioned parallel to a line
at a five degree angle to a line parallel to the longitudinal axis
of the balloon base layer 100. In accordance with another embodiment,
the fibers 47 of the first fiber layer 46 may be positioned parallel
to a line at a twenty degree angle to a line parallel to the longitudinal
axis of the balloon base layer 100.
In accordance with another embodiment, the fibers 47 of the first
fiber layer 46 may be positioned parallel to a line at a thirty
degree angle to a line parallel to the longitudinal axis of the
balloon base layer 100. In accordance with another embodiment, the
fibers 47 of the first fiber layer 46 may be positioned parallel
to a line at a forty-five degree angle to a line parallel to the
longitudinal axis of the balloon base layer 100. It will be apparent
to those having skill in the art that the fibers 47 may be placed
at any appropriate angle.
In accordance with the disclosed embodiment, the fibers 15 of the
second fiber layer 14 lie parallel to the circumference of the balloon
10. With reference to FIG. 12, a fiber-reinforced balloon 40 in
accordance with another embodiment is shown. The fiber reinforced
balloon 40 may include a second fiber layer 43 with fibers 44 that
lie at an angle to the circumference of the balloon 40. In accordance
with one embodiment, the fibers 44 of the second fiber layer 43
may be positioned parallel to a line at a five degree angle to a
line parallel to the circumference of the base balloon 100.
In accordance with one embodiment, the fiber 44 of the second fiber
layer 43 may be positioned parallel to a line at a twenty degree
angle to a line parallel to the circumference of the base balloon
100. In accordance with one embodiment, the fiber 44 of the second
fiber layer 43 may be positioned parallel to a line at a thirty
degree angle to a line parallel to the circumference of the base
balloon 100. In accordance with one embodiment, the fiber 44 of
the second fiber layer 43 may be positioned parallel to a line at
a forty-five degree angle to a line parallel to the circumference
of the base balloon 100. It will be apparent to those skilled in
the art that the fibers 44 may be placed at any appropriate angle.
In accordance with the disclosed embodiment, the fibers 42 of the
first fiber layer 41 and the fibers 44 of the second fiber layer
43 are positioned perpendicularly relative to each other. With reference
to FIG. 13, a fiber-reinforced balloon 50 in accordance with another
embodiment is shown. A fiber-reinforced balloon 50 may include fibers
52 of the first fiber layer 51 and fibers 54 of the second fiber
layer 53 positioned relatively at an angle other than a right angle.
With reference to FIG. 14, a fiber-reinforced balloon 55 in accordance
with one embodiment is shown. It will be apparent to those having
skill in the art that the fibers 57 of the first fiber layer 56
and the fiber 59 of the second fiber layer 58 may be positioned
at any appropriate angle. Placing the fiber 57 of the first fiber
layer 56 and the fibers 59 of the second fiber layer 58 parallel
to each other will result in a balloon 55 with less strength than
a balloon 55 where the fibers 57 and 59 are positioned relatively
at an angle.
With reference to FIG. 15, a fiber-reinforced balloon 60 in accordance
with another embodiment is shown. The fiber-reinforced balloon 60
may include a third fiber layer 63 may be positioned atop the second
fiber layer 62. Typically, the fibers 66 of the third fiber layer
63 may form an angle with the fibers 64 of the second fiber layer
62 and the fibers 67 of the first fiber layer 61. The fibers 66
of the third fiber layer 63 may be formed of the same material as
the fibers 64 of the second fiber layer 62 or the fiber 67 of the
first fiber layer 61 or both.
The fibers 66 of the third fiber layer 63 may be formed in the
same shape as the fibers 64 of the second fiber layer 62 or the
fibers 67 of the first fiber layer 61 or both. An adhesive 126 may
be used to secure the placement of the fibers 66 of the third fiber
layer 63 on the fibers 64 of the second fiber layer 62.
In one embodiment, the fibers 64 of the second fiber layer 62 may
be positioned at a small acute angle, typically about 10 degrees
to the longitudinal fibers 67 of the first fiber layer 61. A third
fiber layer 63 having a fiber 66 at an opposite angle relative to
the longitudinal fibers 67 of the first fiber layer 61 may help
minimizing radial distension. FIG. 16 depicts a fiber-reinforced
balloon 60 having a first fiber layer 61, a second fiber layer 62
and a third fiber layer 63.
With reference to FIG. 17, a fiber-reinforced balloon 70 having
a woven fiber layer 73 in accordance with one embodiment is shown.
Medical textile products are based on fabrics, of which there are
four types: woven, knitted, braided, and non-woven. Weave patterns
are typically comprised of two thread systems, designated warp and
weft. Warp threads 72 run along the length of the fabric, circumferentially
when the fabric is applied to a balloon 70. Weft threads 71 run
along the width. It should be noted that these designations are
arbitrary and the direction of the warp and weft threads may not
correspond to the axis or circumference of a balloon. In the process
of weaving, threads are interlaced in different ways to form various
weave patterns. It will be recognized that fiber-reinforced balloon
70 could be made using any suitable fabric, whether woven, knitted,
braided or non-woven.
The threads of the fabric may be formed from a variety of substances,
typically polymers. In selecting a polymer, it should be recognized
that suitable polymer chains may be linear, long, and flexible.
The side groups should be simple, small, or polar. Suitable polymers
may be dissolvable or meltable for extrusion. Chains should be capable
of being oriented and crystallized.
Common fiber-forming polymers include cellulosics (linen, cotton,
rayon, acetate), proteins (wool, silk), polyamides, polyester (PET),
olefins, vinyls, acrylics, polytetrafluoroethylene (PTFE), polyphenylene
sulfide (PPS), aramids (Kevlar, Nomex), and polyurethanes (Lycra,
Pellethane, Biomer). Each of these materials is unique in chemical
structure and potential properties.
The woven fiber layer 73 typically covers the entire length and
circumference of the barrel of the balloon 70. To form a restraining
structure integral to the fiber-reinforced balloon 70, weft fibers
71 and warp fibers 72 may be woven by passing a weft fiber 71 over
and then under the warp fibers 72 across the surface of the balloon
70. The woven weft fibers 71 and warp fibers 72 may form a woven
fiber layer or other fabric layer 74. The woven fiber layer 74 may
be used in place of either the first fiber layer 12 or the second
fiber layer 14 as those layers are described in other embodiments.
A weft fiber 71 is typically woven with a warp fiber 72 in an interlocking
fashion with each fiber passing over and then under the sequence
of transverse fibers. It will be recognized by those skilled in
the art that the weft fibers 71 may be woven in a variety of weave
patterns with warp fibers 72. Pre-woven fabric may be applied as
a woven fabric layer 74 to the balloon directly. An adhesive layer
126 may be used to fix the position of the fabric layer 74 on the
base balloon layer 100.
With reference to FIG. 18, a cross-section of a fiber-reinforced
balloon 70 including a woven fabric layer 74 is shown. In one embodiment,
the woven fabric layer 74 may be coated with a polymer. In accordance
with another embodiment, a fiber may be wound circumferentially
as a second fiber layer 73 over the woven fiber layer 74. The woven
fiber layer 74 and circumferential fiber layer 73 may be coated
with an outer coating layer polymer 16. The angles formed between
the woven fibers 71 and 72 remain substantially unchanged between
the inflated state of the balloon 70 and the deflated state of the
balloon 70. The balloon 70 is typically folded when deflated, maintaining
the angles between the fibers 71 and 72 upon deflation.
With reference to FIGS. 19 and 20, non-woven fabrics are shown.
In accordance with one embodiment, non-woven fabric may be used
to form a non-woven fabric layer 75. The non-woven fabric layer
75 may be positioned directly on the base balloon layer 100. An
adhesive layer 126 may be used to fix the position of the non-woven
fabric layer 75 to the base balloon layer 100.
The non-woven fabric layer 75 may be formed from parallel taut
fibers 76 joined with a binding solution such as a polymeric solution.
The non-woven fabric layer 75 may be cut into a pattern that may
allow the applied fabric layer 75 to cover the base balloon 100
or mandrel 122.
In accordance with another embodiment, the non-woven fabric layer
77 may be formed as matted fibers 78. The matted fibers 78 may be
joined with a binding solution such as a polymeric solution. Typically
the angles between the fibers 78 of the matted fiber layer 77 are
randomly assorted. When the binding solution has been applied to
the matted fibers 78, the angles between the fibers 78 does not
substantially change, regardless of the pressures applied to the
surface of the matted fabric layer 77.
The non-woven fiber layer 75 may be used in place of either the
first fiber layer 12 or the second fiber layer 14. The non-woven
fiber layer 75 may be applied from pulp, chopped or other forms
of individual fiber elements. The matted fiber 77 may be applied
by spraying, dipping, co-extrusion onto a carrier, wrapping a pre-formed
mat or any other suitable technique.
In one embodiment, the non-woven fabric layer 75 may be coated
with a polymer. In accordance with another embodiment, a fiber 15
may be wound circumferentially over the non-woven fiber layer 75
to form a second fiber layer 14. The non-woven fiber layer 75 and
circumferential fiber layer 14 may be coated with a polymer outer
coating layer 16.
The fiber-reinforced balloon 10, as described, may be substantially
non-compliant. That is, the balloon 10 may be characterized by minimal
axial stretch and minimal radial distention and by the ability not
to expand beyond a predetermined size on pressure and to maintain
substantially a fixed profile.
With reference to FIG. 21, strengthening rods 124 may be placed
around the circumference of a balloon 100. Strengthening rods 124
provide pressure points on the exterior surface of the inflated
balloon, focusing the inflation pressure on the line formed by the
outermost surface of the strengthening rods 124.
In accordance with the disclosed embodiment, the strengthening
rods 124 are positioned longitudinally around the circumference
of the balloon 100. The strengthening rods 124 may be made from
PEEK (polyetheretherketone) or any other suitable material. The
strengthening rods 124 may be used on a fiber-reinforced balloon,
or any other polymeric or medical balloon 79.
The strengthening rods 124 may be of any appropriate size, such
as the length 106 of the barrel of the balloon 79. The strengthening
rods 124 may have any appropriate cross-sectional geometry, including
a circular cross-section, a square cross-section, a triangular cross-section,
a hexagonal cross-section or any other appropriate shape. In another
embodiment, the strengthening rods 124 could be fashioned to form
an outward blade surface. The diameter of the strengthening rods
124 must be small enough to permit the catheter to be effectively
used. The number of strengthening rods and the diameter of the strengthening
rods 124 will be limited by the cross-sectional diameter of the
deflated medical balloon including the strengthening rods 124.
With reference to FIG. 22, a cross-section of a balloon 79 with
strengthening rods 124 is shown. The strengthening rods 124 may
be placed in any suitable position relative to the longitudinal
axis of the balloon 79. The strengthening rods 124 may be of any
suitable length. In accordance with the disclosed embodiment, the
strengthening rods 124 are positioned substantially parallel to
the long axis of the balloon 79, with a length 106 and position
along to the working distance of the barrel of a balloon 79. A cross-section
of the outer tube 210 and the inner tube 212 of the catheter 200
is shown.
The strengthening rods 124 may be secured to the balloon 79 with
a homogeneous outer polymeric layer 16. The homogeneous outer layer
16 may have been applied as a film, spray coating, dipping or other
suitable processes.
When used in angioplasty, the strengthening rods 124 cause the
force generated by the pressure of the inflated balloon 79 to be
concentrated at the strengthening rod 124 outer surface, thus providing
improved fracturing and movement of the calcifications, lesions
or other causes of stenosis inside the affected vessel. When used
in stent deployment, the force required to deploy the stent is concentrated
at the outer surface of the strengthening rods 124, protecting the
balloon surface 79 from abrasion or puncture.
With reference to FIG. 23, a fiber-reinforced balloon catheter
200 is shown. A fiber-reinforced medical balloon 10 may typically
be fixed near the distal end 220 of a catheter tube 208. Balloon
catheters 200 having inflatable balloon attachments have commonly
been used for reaching internal regions of the body for medical
treatments, such as in coronary angioplasty and the like. The fiber-reinforced
medical balloon 10 may be exposed to relatively large amounts of
pressure during these procedures. The profile of the deflated balloon
10 must be relatively small in order to be introduced into blood
vessels and other small areas of the body.
With reference to FIG. 24, a cross-section of a coaxial catheter
tube is shown. A dilating catheter assembly 200 may include a coaxial
tube catheter tube 208, including an outer channel 210 and an inner
channel 212. The coaxial catheter tube 208 may be adapted to be
inserted into the patient and attached to a connector structure
230 which enables both the inner 212 and outer channels 210 of the
coaxial catheter 200 to be supplied with medium such as radio-contrast
fluid.
With reference to FIG. 25, a deflated fiber-reinforced balloon
10 is shown. Catheter 200 assembly has an inner channel 212 and
an outer channel 210 which extend the length of the catheter tube
208. The distal end 220 of the outer tube 210 may be connected to
a fiber-reinforced balloon 10. A folding sheath 222 may be provided
for mechanical deflation of the fiber-reinforced balloon 10.
With reference to FIG. 26, A coupling device 230, such as a conventional
syringe luer, may be used to couple the catheter tube 208 to a syringe
214 used to inflate the fiber-reinforced balloon 10. The flange
portion 232 of the coupling device 230 may be adapted to screw into
a coupling portion 216 of the syringe 212, forming a seal. The wing
portions 234 of the coupling device 230 may be used to twist the
flange portion 232 into the coupling portion 216 of the syringe
214. The coupling body 236 of the coupling device 230 allows the
medium, typically a liquid such as a radio-contrast solution to
pass from the syringe 214 to the fiber-reinforced balloon 10.
With reference to FIG. 27, a typical coaxial coupling device 240
with integral syringes 242 and 244 is shown. In accordance with
one embodiment, the proximal end 207 of the catheter tube 208 including
the coaxial channels 210 and 212 are fed into a connector assembly
218. The inner channel 212 may be fed into a side arm 224 where
it is sealed into a fitting 225. The fitting 225 may be adapted
to receive the front end of syringe 242.
A connecting arrangement 226 may connect the outer channel 210
into the main central arm of connector 240 which may be connected
through a coupler assembly 227. The outer channel 210 may be fed
into main arm 226 where it is sealed into a fitting 228. The fitting
228 may be adapted to receive the front end of a syringe 244.
With reference to FIG. 28, a blocked vessel 400, such as a blocked
coronary artery, having vessel walls 402 and a vessel channel 406
is shown. The vessel 400 may be blocked by deposits 404 such as
plaque. A fiber-reinforced balloon catheter 200 may be used to perform
angioplasty as a treatment for a blocked artery 400. A fiber-reinforced
balloon 10 may be used to open the heart artery 400 as an alternative
to open heart surgery. The fiber-reinforced balloon catheter 200
for use in angioplasty typically includes a small, hollow, flexible
tube 208 and a fiber reinforced balloon 10 attached near the end
of the catheter tube 208.
A fiber-reinforced cutting balloon, formed with sharp aterotomes
attached to the surface of the fiber reinforced balloon 10, may
be used in some cases, particularly where the deposits 404 are solidified.
A fiber-reinforced balloon 79 with strengthening rods 124 may be
used in some procedures that may use a cutting balloon. In some
cases, the strengthening rods 124 may be used to score the plaque
404, allowing the inflated fiber-reinforced balloon 10 to open the
blockage 404 with less trauma than traditional balloon angioplasty.
The fiber-reinforced balloon 10 with strengthening rods 124 may
be used for first-time interventions and for subsequent interventions.
The fiber-reinforced balloon 10 with strengthening rods 124 may
be particularly useful where the plaque 404 blockages are resistant
lesions, particularly found in positions that are difficult or awkward
to address. Bifurcation lesions, for example, occur at the Y-intersection
of an artery 400. The inflation and deflation of the fiber-reinforced
balloon 10 with strengthening rods 124 in this case helps open the
blockage without allowing the plaque 404 to shift position. Fiber-reinforced
balloons 10 with strengthening rods 124 may also be used in the
treatment of restenosis. Lesions at the artery origins may also
be effectively treated using a fiber-reinforced balloon 10 with
strengthening rods 124.
Angioplasty typically starts with the patient lying on a padded
table. Local pain medicine may be given. Catheters may be inserted
in an artery, typically near the groin, in the femoral artery. The
coronary arteries 400 may be remotely visualized by using X-rays
and dye. These visualizations permit blockages in the heart vessels
to be identified.
With reference to FIG. 29, a fiber-reinforced balloon catheter
200 is shown in an inflated state to open a blocked vessel 400.
A fiber-reinforced balloon catheter 200 may be inserted into the
vessel channel 406 or near the blockage 404 and inflated, thus widening
or opening the blocked vessel 400 and restoring adequate blood flow
to the heart muscle.
More specifically, the technique involves use of a fiber-reinforced
catheter system 200 introduced via the femoral artery under local
anesthesia. A pre-shaped guiding catheter may be positioned in the
orifice of the coronary artery. Through this guiding catheter a
second fiber-reinforced dilation catheter 200 is advanced into the
branches of the coronary artery. The fiber-reinforced dilating catheter
200 has an elliptical-shaped distensible fiber-reinforced balloon
portion 10 formed near the distal tip 220 of the catheter 200. The
balloon portion 10 can be inflated and deflated. After traversing
the stenotic lesion of the coronary artery 400, the distensible
fiber-reinforced balloon portion 10 is inflated with fluid under
substantial pressure which compresses the atherosclerotic material
404 in a direction generally perpendicular to the wall 402 of the
vessel 400, thereby dilating the lumen of the vessel 400.
Balloon valvuloplasty, also known as valvuloplasty, balloon dilation
or balloon mitral valvuloplasty, is a non-surgical procedure to
open blocked heart valves that may use a fiber-reinforced balloon
catheter 200.
The procedure involves the insertion of a fiber-reinforced balloon
catheter 200 into the heart. An incision is made between the atria
and the catheter 200 is moved into the blocked valve. When the balloon
catheter 200 is in position, the fiber-reinforced balloon 10 may
be inflated and deflated several times to open the valve. The non-compliance
of the fiber-reinforced balloon 10 under pressure may provide benefits
in such procedures.
Fiber-reinforced medical balloons 10 may be used in the treatment
of broken or fractured vertebrae. A fiber-reinforced medical balloon
10 may be inserted into the region of the fracture. The minimally
invasive procedure may require only a half-inch incision to insert
the medical balloon 10. The fiber-reinforced balloon 10 may be inflated
to an appropriate diameter to raise the collapsed bone. The space
created by the fiber-reinforced balloon 10 may be filled with the
a cementing substance, such as the cement used in hip and knee replacements.
With reference to FIG. 30, a fiber-reinforced medical balloon 10
for a collapsed or ruptured disc is shown. The disk 410 between
the vertebrae 408 may cease to separate the vertebrae 408 as shown.
With reference to FIG. 31, a fiber-reinforced medical balloon 10
may be inserted between the vertebrae 408 and inflated. The space
created by the fiber-reinforced balloon 10 may be filled with the
a cementing substance, such as the cement used in hip and knee replacements.
Kyphoplasty may be used in the treatment of pain associated with
osteoporotic compression fractures. The procedure helps stabilize
the bone and restores vertebral body height. By inflating a fiber-reinforced
medical balloon inside the fractured vertebra, the bone position
is restored to allow for the injection of medical cement. This procedure
stabilizes the fracture and promotes healing. The stabilization
alone can provide immediate pain relief for many patients.
Kyphoplasty is performed through a small incision in the back.
A narrow tube, placed in the incision, is guided to the correct
position using fluoroscopy. The physician uses X-ray images to insert
the fiber-reinforced medical balloon into the tube and into the
vertebra. The fiber-reinforced balloon is gently inflated, elevating
the fracture and returning the pieces of the vertebra to a more
normal position. The inner bone is also compacted, creating a cavity
which is filled with medical bone cement that hardens quickly and
stabilizes the bone. Alternatively, the medical balloon may remain
in the body and bone cement is filled inside the balloon to stabilize
the vertebral body.
Another use of fiber-reinforced medical balloons is in carpal tunnel
therapy. Balloon carpal tunnel-plasty may be performed using a fiber-reinforced
balloon catheter device. The fiber-reinforced balloon catheter may
be used with a specialized nerve protector to stretch and expand
the transverse carpal ligament relieving the symptoms of carpal
tunnel syndrome. The procedure may be performed through a one-centimeter
size incision at the distal palmar crease ulnar to the palmaris
longus in line with the fourth ray. The approach is identical to
the single portal endoscopic technique. The fiber-reinforced medical
balloon is used to dilate and expand the transverse carpal ligament
to increase the spatial diameter of the carpal tunnel and relieve
pressure on the median nerve alleviating symptoms of carpal tunnel
syndrome.
Fiber-reinforced medical balloons may be used in radiation therapy.
Where a tumor has been removed, a fiber-reinforced balloon catheter
may be inserted. The inflated fiber-reinforced balloon fills the
cavity where the tumor was removed from. Radiation is delivered
into the fiber-reinforced balloon periodically.
Fiber reinforced medical balloons may be used in the treatment
of nasolacrimal duct obstruction. Nasolacrimal duct obstruction
can cause a condition called epiphora, characterized by chronic
tearing. Dacryocystoplasty, a non-surgical treatment, is performed
as an outpatient procedure after topical anesthesia. It entails
the passage of a fluoroscopically guided wire through the lacrimal
duct, followed by dilation of a fiber-reinforced balloon at the
site of obstruction.
Another use of fiber-reinforced medical balloons is the treatment
of benign prostatic hypertrophy. A fiber-reinforced balloon is inflated
to dilate the prostatic urethra. Balloon urethroplasty is a therapeutic
procedure intended to manage symptoms associated with benign prostatic
hypertrophy. Under fluoroscopic guidance, a flexible catheter with
a fiber-reinforced balloon attachment is placed in the urethra at
the level of the prostate above the external sphincter. The fiber-reinforced
balloon is then inflated for a short period of time to distend the
prostatic urethra. This widening process is intended to relieve
obstruction of the urethra caused by the enlarged prostate and to
alleviate the symptoms of benign prostatic hypertrophy.
It will be appreciated by those skilled in the art having the benefit
of this disclosure that this invention provides a non-complian medical
balloon. It should be understood that the drawings and detailed
description herein are to be regarded in an illustrative rather
than a restrictive manner, and are not intended to limit the invention
to the particular forms and examples disclosed. On the contrary,
the invention includes any further modifications, changes, rearrangements,
substitutions, alternatives, design choices, and embodiments apparent
to those of ordinary skill in the art, without departing from the
spirit and scope of this invention, as defined by the following
claims. Thus, it is intended that the following claims be interpreted
to embrace all such further modifications, changes, rearrangements,
substitutions, alternatives, design choices, and embodiments.
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