U.S. patent application number 13/924707 was filed with the patent office on 2013-12-12 for non-compliant medical balloon having an integral non-woven fabric layer.
The applicant listed for this patent is BARD PERIPHERAL VASCULAR, INC.. Invention is credited to William F. DAVIES, JR., Kelli HAYES, Lanny R. PEPPER.
Application Number | 20130331784 13/924707 |
Document ID | / |
Family ID | 36181761 |
Filed Date | 2013-12-12 |
United States Patent
Application |
20130331784 |
Kind Code |
A1 |
PEPPER; Lanny R. ; et
al. |
December 12, 2013 |
NON-COMPLIANT MEDICAL BALLOON HAVING AN INTEGRAL NON-WOVEN FABRIC
LAYER
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 randomly
oriented fibers forming an angle. The angle remains substantially
unchanged when the balloon changes from a deflated state to an
inflated state.
Inventors: |
PEPPER; Lanny R.; (Larue,
TX) ; HAYES; Kelli; (Athens, TX) ; DAVIES,
JR.; William F.; (Athens, TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BARD PERIPHERAL VASCULAR, INC. |
Tempe |
AZ |
US |
|
|
Family ID: |
36181761 |
Appl. No.: |
13/924707 |
Filed: |
June 24, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13548314 |
Jul 13, 2012 |
8469926 |
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13924707 |
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12696863 |
Jan 29, 2010 |
8221351 |
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13548314 |
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10967065 |
Oct 15, 2004 |
7682335 |
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12696863 |
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Current U.S.
Class: |
604/103.12 ;
156/166; 156/226; 156/280; 156/60 |
Current CPC
Class: |
Y10T 156/1049 20150115;
A61L 29/06 20130101; Y10T 156/10 20150115; A61L 29/126 20130101;
Y10T 428/1359 20150115; A61M 25/1027 20130101; A61L 29/085
20130101; A61L 2420/02 20130101; A61M 25/10 20130101 |
Class at
Publication: |
604/103.12 ;
156/226; 156/60; 156/280; 156/166 |
International
Class: |
A61M 25/10 20060101
A61M025/10 |
Claims
1. A method of making a non-compliant balloon comprising: forming a
base balloon from a polymer material to form a flexible and
substantially inelastic base balloon having a generally cylindrical
barrel with a substantially fixed first circumference, first and
second cylindrical end portions each having a proximate and distal
end and a substantially fixed second circumference smaller than the
first circumference and first and second transition portions each
having a proximate end and a distal end, each transition portion
extending from an end of the barrel to a proximate end of one of
the cylindrical end portions; applying a non-woven layer of
substantially inelastic first fibers over the base balloon, the
first fibers comprising randomly oriented fibers defining random
intersection angles at a plurality of locations where the first
fibers intersect and cross over each other; applying at least one
outer coating over the randomly oriented first fibers, the coating
comprising a polymeric solution; curing the outer coating to form
an outer layer, folding the balloon with balloon folds on the outer
surface such that the balloon may be pressurized to an inflated
state having an unfolded configuration with a substantially smooth
outer surface by increasing the pressure within the base balloon;
and wherein the random angles between the intersecting randomly
oriented first fibers are fixed in position relative to the base
balloon such that the angle at which each of the randomly oriented
fibers intersects another randomly oriented fiber remains constant
when the balloon is inflated and deflated.
2. The method of claim 1 wherein the step of applying a non-woven
layer of substantially inelastic first fibers over the base balloon
comprises applying substantially ribbon shaped fibers over the base
balloon.
3. The method of claim 1 wherein the step of applying a non-woven
layer of substantially inelastic first fibers over the base balloon
comprises applying a non-woven fiber fabric in place over the base
balloon.
4. The method of claim 3 further comprising applying an adhesive to
the non-woven fiber fabric.
5. The method of claim 1 further comprising applying a
substantially inelastic hoop fiber over the first, randomly
oriented fibers, the hoop fiber extending around the balloon in a
series of substantially parallel circumferential continuous loops
from the distal end of the first transition section to the distal
end of the second transition section.
6. The method of claim 1, including the step of providing the base
balloon formed by one of blow molding a polymer material and
applying a polymer layer to a mandrel.
7. The method of claim 1 including the step of forming the base
balloon from an oriented polyethylene terephthalate.
8. A method of forming a non-compliant balloon from a flexible and
substantially inelastic base balloon having a barrel with a
substantially fixed first circumference, first and second end
portions each having a proximate and distal end and a substantially
fixed second circumference smaller than the first circumference and
first and second transition portions each having a proximate end
and a distal end, each transition portion extending from an end of
the barrel to a proximate end of one of the end portions,
comprising: providing a non-woven layer of substantially inelastic
first fibers over the base balloon, the first fibers comprising
randomly oriented fibers defining random intersection angles at a
plurality of locations where the first fibers intersect and cross
over each other, wherein the random angles between the intersecting
randomly oriented first fibers are fixed in position relative to
the base balloon such that the angle at which each of the randomly
oriented fibers intersects another randomly oriented fiber remains
constant when the balloon is inflated and deflated.
9. The method of claim 8, further including the step of folding the
balloon with balloon folds on the outer surface such that the
balloon may be pressurized to an inflated state having an unfolded
configuration with a substantially smooth outer surface by
increasing the pressure within the base balloon; and
10. The method of claim 8, further including the step of forming an
outer layer comprising at least one outer coating over the randomly
oriented first fibers.
11. The method of claim 10, further including the step of curing
the outer coating to form the outer layer.
12. The method of claim 8, wherein the step of providing a
non-woven layer of substantially inelastic first fibers over the
base balloon comprises applying substantially ribbon shaped fibers
over the base balloon.
13. The method of claim 8 wherein the step of providing a non-woven
layer of substantially inelastic first fibers over the base balloon
comprises applying a non-woven fiber fabric in place over the base
balloon.
14. The method of claim 13, further comprising applying an adhesive
to the non-woven fiber fabric.
15. The method of claim 8 further comprising applying a
substantially inelastic hoop fiber over the first, randomly
oriented fibers, the hoop fiber extending around the balloon in a
series of substantially parallel circumferential continuous loops
from the distal end of the first transition section to the distal
end of the second transition section.
16. A method of forming a non-compliant balloon including a
flexible and substantially inelastic base balloon having a barrel
portion with a substantially fixed first circumference, first and
second end portions each having a proximate and distal end and a
second circumference smaller than the first circumference and first
and second transition portions each having a proximate end and a
distal end, each transition portion extending from an end of the
barrel to a proximate end of one of the end portions, and a
non-woven layer of substantially inelastic first fibers over the
base balloon, the first fibers comprising randomly oriented fibers
defining intersection angles at a plurality of locations where the
first fibers intersect and cross over each other, and at least one
outer coating over the randomly oriented first fibers, the coating
comprising a polymeric solution, comprising: fixing the
intersecting randomly oriented first fibers in position relative to
the base balloon such that the intersecting angle between each of
the intersecting randomly oriented fibers remains constant when the
balloon is inflated and deflated.
17. The method of claim 16, further including the step of folding
the balloon with balloon folds on the outer surface such that the
balloon may be pressurized to an inflated state having an unfolded
configuration with a substantially smooth outer surface by
increasing the pressure within the base balloon.
18. The method of claim 16, wherein the fixing step comprises
forming an outer layer comprising at least one outer coating over
the randomly oriented first fibers.
19. The method of claim 18, further including the step of curing
the outer coating to form the outer layer.
20. A catheter including the non-compliant balloon formed according
to claim 16.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a divisional of Ser. No. 12/696,863,
which is a continuation of U.S. patent application Ser. No.
10/967,065, filed 15 Oct. 2004, and entitled NON-COMPLIANT MEDICAL
BALLOON HAVING AN INTEGRAL NON-WOVEN FABRIC LAYER, the
specification of which is incorporated herein by reference in its
entirety.
[0002] This application is related to U.S. patent application Ser.
No. 11/751,489, filed May 21, 2007, and entitled NON-COMPLIANT
MEDICAL BALLOON HAVING AN INTEGRAL NON-WOVEN FABRIC LAYER, the
specification of which is incorporated herein by reference in its
entirety.
TECHNICAL FIELD
[0003] 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
[0004] 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.
[0005] 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.
[0006] 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.
[0007] 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.
[0008] Medical balloons are commonly used in angioplasty,
orthopedics and other medical procedures where it is necessary to
force a space within the body.
[0009] 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.
[0010] 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.
[0011] 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
[0012] 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
[0013] FIG. 1A illustrates a semi-cross section of a
fiber-reinforced medical balloon;
[0014] FIG. 18 illustrates a deflated fiber-reinforced medical
balloon;
[0015] FIG. 2 illustrates an inflated balloon base layer;
[0016] FIG. 3 illustrates a balloon-shaped mandrel;
[0017] FIG. 4 illustrates a balloon base layer having an adhesive
layer;
[0018] FIG. 5 illustrates a first fiber layer;
[0019] FIG. 6 illustrates a cross-section of a balloon base layer,
adhesive layer and first fiber layer;
[0020] FIG. 7 illustrates a cross-section of a balloon base layer,
adhesive layer and first fiber layer;
[0021] 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;
[0022] 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;
[0023] FIG. 10 illustrates a fiber-reinforced medical balloon with
a longitudinal first fiber layer and a circumferential second fiber
layer;
[0024] FIG. 11 illustrates a fiber-reinforced medical balloon with
a longitudinal first fiber layer and an angled second fiber
layer;
[0025] FIG. 12 illustrates a fiber-reinforced medical balloon
having an angled first fiber layer and a circumferential second
fiber layer;
[0026] FIG. 13 illustrates a fiber-reinforced medical balloon
having a longitudinal first fiber layer and an angled second fiber
layer;
[0027] FIG. 14 illustrates a fiber-reinforced medical balloon
having an angled first fiber layer and an angled second fiber
layer;
[0028] 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;
[0029] FIG. 16 illustrates a fiber-reinforced medical balloon
having a longitudinal first fiber layer, an angled second fiber
layer and a third fiber layer;
[0030] FIGS. 17A and 17B illustrate a fiber-reinforced medical
balloon having a woven, fiber layer;
[0031] FIG. 18 illustrates a cross-section including a woven fiber
layer; and
[0032] FIG. 19 illustrates a fabric layer including taut parallel
fibers;
[0033] FIG. 20 illustrates a fabric layer including matted
fibers;
[0034] FIG. 21 illustrates a medical balloon having attached
strengthening rods;
[0035] FIG. 22 illustrates a cross-section of a medical balloon
having attached strengthening rods;
[0036] FIG. 23 illustrates a balloon catheter;
[0037] FIG. 24 illustrates a cross-section of a balloon catheter
tube;
[0038] FIG. 25 illustrates a deflated fiber-reinforced medical
balloon;
[0039] FIG. 26 illustrates a balloon catheter, connector and
syringe;
[0040] FIG. 27 illustrates a balloon catheter and a pressurized
fluid delivery system;
[0041] FIG. 28 illustrates a cross-section of a blocked vessel;
[0042] FIG. 29 illustrates a cross-section of a blocked vessel
containing an inflated balloon catheter;
[0043] FIG. 30 illustrates vertebrae and a vertebral body; and
[0044] FIG. 31 illustrates vertebrae treated with a balloon
catheter.
DETAILED DESCRIPTION
[0045] Referring now to the drawings, wherein like reference
numbers are used to designate like elements throughout the various
views, several embodiments 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.
[0046] With reference to FIG. 1A, a cross section of an inflated
fiber-reinforced medical balloon 10 is shown. With reference to
FIG. 18, 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.
[0047] 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.
[0048] The fiber-reinforced balloon 10 is generally suitable for
use as a medical balloon. Medical balloons are commonly used in
angioplasty, orthopedics 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.
[0049] 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.
[0050] 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 bust
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.
[0051] 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, or 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 that 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.
[0052] 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.
[0053] 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).
[0054] 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 an balloons without sacrifice of burst
strength, abrasion resistance, 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.
[0055] 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.
[0056] 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.
[0057] 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 that 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.
[0058] 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.
[0059] 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."
[0060] 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.
[0061] 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.
[0062] 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.
[0063] 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.
[0064] 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.
[0065] 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.
[0066] 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.
[0067] 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.
[0068] 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.
[0069] 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.
[0070] 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.
[0071] 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, Telon (PBT),
Zylon (PBO), Polyimide (PIM), other ultra high molecular weight
polyethylene, aramids, and the like.
[0072] 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.
[0073] 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 polyurethane 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.
[0074] 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.
[0075] 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.
[0076] 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.
[0077] 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.
[0078] 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 polyurethane 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.
[0079] 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.
[0080] 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.
[0081] A balloon-shaped solid mandrel 122 made of a low melting
temperature metal alloy may be coated with a thin layer of
polyurethane/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 polyurethane/DMA
outer coating layer 16.
[0082] 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.
[0083] 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.
[0084] 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 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.
[0085] 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.
[0086] 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 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.
[0087] 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.
[0088] 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.
[0089] 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.
[0090] 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.
[0091] 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.
[0092] 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.
[0093] 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.
[0094] 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.
[0095] 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.
[0096] 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.
[0097] 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.
[0098] With reference to FIGS. 17A and 17B, 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.
[0099] 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.
[0100] 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.
[0101] 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.
[0102] 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.
[0103] 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.
[0104] 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.
[0105] 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.
[0106] 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.
[0107] The non-woven fiber layer 75 may be used in place of either
the first fiber layer 12 or the second fiber layer 24. 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.
[0108] 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.
[0109] 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.
[0110] 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.
[0111] 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.
[0112] 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.
[0113] 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.
[0114] 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.
[0115] 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.
[0116] 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.
[0117] 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.
[0118] 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.
[0119] 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.
[0120] 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.
[0121] 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.
[0122] 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.
[0123] 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.
[0124] 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.
[0125] 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.
[0126] 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 401.
[0127] 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.
[0128] 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.
[0129] 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 a cementing substance, such as the cement
used in hip and knee replacements.
[0130] 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 a cementing substance, such as the cement used in hip and knee
replacements.
[0131] 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.
[0132] 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.
[0133] 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 palmer 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.
[0134] 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.
[0135] 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.
[0136] 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.
[0137] It will be appreciated by those skilled in the art having
the benefit of this disclosure that this invention provides a
non-compliant 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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