Patent Publication Number: US-10786658-B2

Title: Non-compliant medical balloon having an integral non-woven fabric layer

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     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. 
     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 
     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 
     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. Over inflating 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. 
     Noncompliance, 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 
     A non-compliant medical balloon may be changed from a deflated state to an inflated slate 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 fanning 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 balloon; 
         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; 
         FIGS. 17A and 17B  illustrate a fiber-reinforced medical balloon having a woven fiber layer; 
         FIG. 18  illustrates a cross-section including a woven fiber layer and 
         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; and 
         FIG. 31  illustrates vertebrae treated with a balloon catheter 
     
    
    
     DETAILED DESCRIPTION 
     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 mi will appreciate the many possible applications and variations of the present invention based on the following examples of possible embodiments. 
     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 seventy 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 mt 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, or any other suitable shape. A standard polymeric balloon may function a s 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 (one 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 terephtha late (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 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. 
     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 that conform to the present art of fanning 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® 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 the 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 useful 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 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 . 
     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, fibers  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® 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 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. 
     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 fl1m1 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 polyurethane/OMA solution (10%) as a 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/OMA 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 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 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 . bi 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  are 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 ninety 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 form 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  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. 
     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 form 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  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-fanned 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 follow 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 fluid 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  be 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 a s 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 arthrotomes 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 I 0  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 is 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 limes 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 a cementing substance, such as the cement used in hip and knee replacements. 
     With reference to  FIG. 30 , a fiber-reinforced medical balloon  100  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. 
     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 b y 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-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.