Patent Description:
The disclosure relates to intravascular medical devices such as medical balloons and methods of making the same.

Medical balloons may be utilized in a variety of medical treatments. For example, in an angioplasty procedure, a medical balloon may be used to expand a diseased body lumen. Medical balloons may also be used to deliver and deploy an expandable endoprosthesis, such as a stent, at a target site within a body lumen.

Medical balloons may be delivered to a target site by advancing a balloon catheter over a guidewire to the target site. In some cases, the pathway to a target site may be tortuous and/or narrow. Upon reaching the site, the balloon may be expanded by injecting a fluid into the interior of the balloon. Expanding the balloon may radially expand the stenosis such that normal blood flow may be restored through the body lumen.

In some instances, a high pressure medical balloon may be utilized when treating a particular target site (e.g., a stenosis). Further, in some instances a balloon may be utilized which includes a reinforcing/strengthening material. For example, to achieve the high pressure, some medical balloons may include one or more fiber braids designed to increase the radial strength of the balloon. Examples disclosed herein may include medical devices and methods for manufacturing those devices having a fiber braid.

<CIT> discloses a reinforced dilatation balloon, and a method of making, wherein the balloon includes a balloon body having a continuous polymer tube (e.g., generally cylindrical) having a proximal end, a distal end, and an external surface, and a tubular fiber reinforcing sleeve thermally bonded along the length of the sleeve to at least a portion of the external surface of the balloon body. <CIT> discloses medical devices and related methods.

The invention is defined by a catheter assembly and a method of making a catheter assembly according to the independent claims.

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example catheter assembly includes a catheter shaft and a balloon attached to the catheter shaft. The balloon includes a body and a proximal waist portion, the proximal waist portion having an proximal end. The catheter assembly further includes a fiber braid including one or more individual filaments disposed along the balloon. The fiber braid has a proximal end aligned with the proximal end of the waist portion. The catheter assembly further includes a polymer sleeve disposed on the catheter shaft, wherein the polymer sleeve abuts the proximal end of the balloon waist and the proximal end of the braid.

The polymer sleeve includes a distal end, and a portion of the distal end of the polymer sleeve extends into the proximal end of the waist portion.

Alternatively or additionally to any of the embodiments above, wherein the polymer sleeve includes a distal end, and a portion of the distal end of the polymer sleeve extends into the proximal end of the braid.

Alternatively or additionally to any of the embodiments above, wherein one or more portions of the polymer sleeve is wicked along one or more individual filaments of the braid within the waist portion.

Alternatively or additionally to any of the embodiments above, wherein the polymer sleeve is thermally bonded to the waist portion.

Alternatively or additionally to any of the embodiments above, wherein the polymer sleeve is thermally bonded to the braid.

Alternatively or additionally to any of the embodiments above, wherein the waist portion and the polymer sleeve are thermally bonded to catheter shaft.

Alternatively or additionally to any of the embodiments above, wherein the balloon waist comprises a polymer.

Alternatively or additionally to any of the embodiments above, wherein the polymer of the balloon waist is different from the polymer that comprises the polymer sleeve.

Alternatively or additionally to any of the embodiments above, wherein the polymer of the balloon waist has a melting point that is greater than the melting point of the polymer of the polymer sleeve.

Alternatively or additionally to any of the embodiments above, wherein the melting point of the polymer of the balloon waist matches the melting point of the polymer of the polymer sleeve.

Alternatively or additionally to any of the embodiments above, wherein the fiber braid comprises a material having a melting point greater than the melting point of the waist or the polymer of the polymer sleeve.

Alternatively or additionally to any of the embodiments above, wherein the polymer sleeve is interlocked with one or more of the filaments of the fiber braid.

Another example catheter assembly includes:.

An example method of making a catheter assembly includes:.

Alternatively or additionally to any of the embodiments above, wherein disposing the polymer sleeve on the catheter shaft includes overlapping the polymer sleeve with the end of the waist portion.

Alternatively or additionally to any of the embodiments above, wherein overlapping the polymer sleeve with the end of the waist portion includes position the polymer sleeve radially inward of the waist portion.

Alternatively or additionally to any of the embodiments above, wherein a portion of the polymer sleeve wicks along one or more fibers of the fiber braid.

Alternatively or additionally to any of the embodiments above, wherein thermally bonding the polymer sleeve to the balloon waist further includes interlocking the polymer sleeve with one or more fibers of the fiber braid.

Alternatively or additionally to any of the embodiments above, wherein the polymer sleeve extends into the waist portion such that the polymer sleeve at least partially surrounds at least one or more fibers of the fiber braid.

s, and Detailed Description, which follow, more particularly exemplify these embodiments.

On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure.

The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure.

As used herein, the terms "proximal" and "distal" refer to that which is closest to the user such as a surgeon and that which is furthest from the user respectively.

As discussed above, medical balloons may be utilized in a variety of medical treatments. For example, in an angioplasty procedure, a medical balloon may be used to widen a diseased body lumen, such as a arteries in the vasculature. A medical balloon may also be used to deliver and deploy an expandable endoprosthesis, such as a stent, at a target site within a body lumen.

In some instances it may be desirable to utilize high pressure medical balloons when treating a particular target site (e.g., a stenosis). Further, in some instances it may be desirable to utilize a balloon which includes a reinforcing/strengthening material. For example, to achieve the high pressure, some medical balloons may include one or more fiber braids designed to increase the radial strength of the balloon. Examples disclosed herein may include medical devices and methods for manufacturing those devices having a fiber braid.

<FIG> shows example balloon catheter system <NUM>. System <NUM> may include an expandable medical balloon <NUM> mounted to a distal end of a catheter shaft <NUM>. The catheter shaft <NUM> may extend from a manifold assembly <NUM> positioned at a proximal end of the catheter shaft <NUM>. Balloon <NUM> is shown having a body portion <NUM>, a proximal cone portion <NUM>, a distal cone portion <NUM>, a proximal waist portion <NUM>, and a distal waist portion <NUM>. Balloon <NUM> may be secured to the catheter shaft <NUM> at the proximal waist <NUM> and distal waist portions <NUM>, respectively.

Catheter shaft <NUM> may include a guidewire lumen (not shown) extending therein and an inflation lumen (not shown) extending therein for inflation of balloon <NUM>. Alternatively, the catheter shaft <NUM> may include an inner tubular member defining a guidewire lumen and an outer tubular member disposed around the inner tubular member, whereby an inflation lumen may be defined between the inner tubular member and the outer tubular member.

Additionally, and as illustrated in <FIG>, balloon <NUM> may include a fiber braid <NUM> disposed thereon. Fiber braid <NUM> may be disposed along an outer surface of balloon <NUM>. However, this is not intended to be limiting. Rather, it is contemplated that braid <NUM> may be partially or fully embedded in the wall of balloon <NUM>. It can further be appreciated that fiber braid <NUM> may extend around the circumference of balloon <NUM>. Specifically, braid <NUM> may wrap around the circumference of balloon <NUM>.

Fiber braid <NUM> may include one or more filaments <NUM>. Further, fiber braid <NUM> may be configured such that the one or more filaments <NUM> are braided, wound, wrapped, woven, etc. around the outer surface and/or partially or fully within the wall of balloon <NUM>. Additionally, filaments <NUM> may be braided, wound, wrapped, woven, etc. in a variety of configurations around the outer surface and/or partially or fully within the wall of balloon <NUM>.

In some examples, the inner surface of at least one of the proximal waist portion <NUM> and /or the distal waist portion <NUM> are bonded (e.g., thermally, adhesively, etc.) to an outer surface of a portion of the catheter shaft <NUM> prior to bonding of the fiber braid <NUM> to the proximal waist portion <NUM> and/or the distal waist portions <NUM>. As used herein, thermal bonding refers to the melting of materials or a portion thereof by applying heat, laser, welding or some combination thereof, to obtain a mixing or bonding of the materials at the material interface. Alternatively, an inner surface of the fiber braid <NUM> may be adhesively bonded to an outer surface of the proximal waist portion <NUM> and distal waist portion <NUM>. Additionally, it is contemplated the fiber braid <NUM> may be attached to balloon <NUM> via any suitable process, including heat welding, laser welding, etc..

Further, a suitable adhesive may be employed for bonding the fiber braid <NUM> to the balloon <NUM>, including proximal waist portion <NUM>, and distal waist portion <NUM>. The adhesive may include, but is not limited to, for example, thermoset adhesives that suitably cure either via a chemical reaction or irradiation. Specific examples of suitable thermoset adhesives include moisture cure and radiation cure such as ultraviolet (UV) radiation cure, e-beam, and the like. In some embodiments, the adhesive is a thermoset cyanoacrylate adhesive. A particular example is Loctite <NUM> available from Henkel Adhesives.

<FIG> illustrates the proximal portion of an example balloon <NUM> bonded to a portion of catheter shaft <NUM>. As shown in <FIG>, one of more filaments <NUM> of fiber braid <NUM> may extend in a proximal direction from the balloon body <NUM>, along the proximal balloon cone <NUM> and further along the proximal balloon waist <NUM>. Additionally, <FIG> illustrates a bonding sleeve <NUM> disposed along the proximal portion of the proximal waist <NUM>. As will be described in detail below, bonding sleeve <NUM> may be designed to cover, encapsulate, embed and/or seal the proximal portion of the braid <NUM> located at the proximal portion of the proximal waist <NUM>.

The detailed view shown in <FIG> illustrates that a portion of bonding sleeve <NUM> may extend along a proximal portion of the proximal waist <NUM>. As will be described in greater detail below, the bonding sleeve <NUM> may be designed such that it extends in a proximal-to-distal direction along at least a portion the proximal waist <NUM>. Specifically, the detailed view of <FIG> shows that bonding sleeve <NUM> may extend over the end of the proximal waist <NUM> of balloon <NUM> (the end of the proximal waist <NUM> of balloon <NUM> is depicted as dashed line <NUM> in the detailed view of <FIG>). Additionally, the detailed view of <FIG> illustrates that bonding sleeve <NUM> may wick and/or flow in a distal-to-proximal direction along the fibers <NUM> of braid <NUM>. A distal portion <NUM> of bonding sleeve <NUM> is depicted in both the detailed and non-detailed views of <FIG>. It can be appreciated the distal portion <NUM> of bonding sleeve <NUM> may or may not terminate a uniform distance from end of proximal waist <NUM>. For example, it can be appreciated that as bonding sleeve <NUM> wicks and/or flows in a distal-to-proximal direction along the fibers <NUM> of braid <NUM>, that some portions of bonding sleeve may advance further along the braid <NUM> than other adjacent portions (as depicted by the jagged line of distal portion <NUM> of bonding sleeve <NUM>).

<FIG> illustrates an example step in manufacturing catheter system <NUM>. <FIG> shows that the proximal waist <NUM> may be trimmed to an appropriate length prior to bonding the proximal waist <NUM> of balloon <NUM> to catheter shaft <NUM>. <FIG> illustrates that the proximal waist <NUM> of balloon <NUM> has been cleanly cut along proximal edge <NUM>. Further, <FIG> illustrates that the trimming process of proximal balloon waist <NUM> may reveal a proximal face <NUM> of the proximal waist <NUM>. Further, the proximal face <NUM> shows the ends <NUM> of one or more fibers <NUM> of braid <NUM>. The ends <NUM> of fibers are positioned along the proximal face <NUM>. In other words, the trimming process may result in the end <NUM> of the proximal balloon waist aligning with the ends <NUM> of the one or more fibers <NUM> of braid <NUM>.

As shown in <FIG>, it can be appreciated the trimming process may result in one or more of fibers <NUM> becoming exposed along either the proximal face <NUM> and/or along the outer surface of proximal balloon waist <NUM>. Further, the trimming process may cause the ends <NUM> of the one or more fibers <NUM> to become unraveled, frayed, exposed, released and/or unattached to the proximal waist <NUM> and/or proximal face <NUM>. In some instances, the ends <NUM> of one or more fibers <NUM> may extend radially outward of the outer diameter of the proximal waist <NUM>. Further, it can be appreciated that it may be undesirable to have the ends <NUM> of one or more fibers <NUM> extending/projecting away from balloon waist <NUM> as they may interfere with a medical devices and/or delivery systems utilized in conjunction with catheter system <NUM>. For example, the ends <NUM> of the one or more fibers <NUM> may interfere with a stent being positioned on balloon <NUM>. Therefore, it may be desirable to recapture, cover, encase, encapsulate, overlay and/or seal the ends <NUM> of the one or more fibers <NUM> within another material. For example, it may be desirable to recapture, cover, encase, encapsulate, overlay and/or seal the ends <NUM> of the one or more fibers <NUM> with a bonding sleeve <NUM> as described above.

<FIG> shows an example assembly step in manufacturing catheter system <NUM>. <FIG> shows a bonding sleeve <NUM> (prior to being melted) being positioned on catheter shaft <NUM>. Further, <FIG> shows catheter shaft <NUM> extending through the proximal waist <NUM>. Additionally, <FIG> shows balloon <NUM> (including proximal waist <NUM>) being advanced toward bonding sleeve <NUM>. However, while <FIG> illustrates balloon <NUM> (including proximal waist <NUM>) being advanced toward bonding sleeve <NUM>, it is also contemplated that bonding sleeve <NUM> may be advanced toward proximal waist <NUM>.

<FIG> shows another example assembly step in manufacturing catheter system <NUM>. <FIG> shows that bonding sleeve <NUM> and/or and proximal waist <NUM> have been moved to a position in which it abuts proximal waist <NUM> of balloon <NUM>. In other words, <FIG> illustrates that a portion of the proximal face <NUM> (shown in <FIG>) of proximal waist <NUM> may create a butt joint (e.g., a joint in which the proximal face of the proximal waist <NUM> may contact a distal face of the bonding sleeve <NUM>) prior to the bonding process. However, this is not intended to be limiting. Other arrangements of proximal waist <NUM>, bonding sleeve <NUM> and catheter shaft <NUM> are contemplated. For example, it is contemplated that the distal portion of bonding sleeve <NUM> may overlap with the proximal end of the proximal waist <NUM> prior to the bonding process.

<FIG> shows another example assembly step in manufacturing catheter system <NUM>. <FIG> shows an example process for melting bonding sleeve <NUM> such that it melts and/or reflows over the proximal end of the proximal waist <NUM>. <FIG> illustrates a piece of heat shrink <NUM> positioned over the proximal waist <NUM>, the bonding sleeve <NUM> and the catheter shaft <NUM>. Additionally, <FIG> shows energy <NUM> (e.g., laser energy, thermal energy, etc.) being applied to the heat shrink <NUM>. Further, the heat shrink <NUM> may transfer/disperse the energy to the bonding sleeve <NUM>, proximal waist <NUM> and/or the catheter shaft <NUM>, thereby thermally bonding the bonding sleeve <NUM> to the proximal waist <NUM> and/or the catheter shaft <NUM>.

It can be appreciated that the melting points of the balloon material, fibers <NUM>, bonding sleeve <NUM>, and catheter shaft may be the same or they may be different. For example, it may be desirable for the bonding sleeve <NUM> to be made from a material having a melting point which is lower than the balloon material, fibers <NUM> and/or bonding sleeve <NUM>. For example, all or a portion of balloon <NUM> (including proximal balloon waist <NUM>) may be manufactured from Pebax®, which has an approximate melt temperature of <NUM>. All or a portion of catheter shaft <NUM> may be manufactured from Grilamid L20®, for example, which has an approximate melt temperature of <NUM>. All or a portion of fibers <NUM> may include Vectran®, for example, which has an approximate melt temp of <NUM> and does not melt at bonding temps.

It can be appreciated that the catheter system <NUM> illustrated and described with respect to <FIG> may be the configuration of the catheter system <NUM> after processing the catheter system as described in <FIG>. In other words, the illustration and description of the bonding sleeve and proximal waist interface in <FIG> may represent the catheter after it undergoes the processing and bonding steps as described in <FIG>.

<FIG> illustrates a cross-sectional view of the proximal waist <NUM>, bonding sleeve <NUM> and catheter shaft <NUM> after the bonding step has been performed as described in <FIG>. <FIG> illustrates one or more ends <NUM> of fibers <NUM> being captured, covered, encased, encapsulated, overlaid and/or sealed by the material of bonding sleeve <NUM>. For example, <FIG> shows that after energy <NUM> is applied during the assembly step as described in <FIG>, the bonding sleeve <NUM> may melt and/or reflow into and around the ends <NUM> of fibers <NUM> of braid <NUM>. It is noted that <FIG> does not show heat shrink <NUM> (shown in <FIG>) positioned over the proximal waist <NUM> and/or bonding sleeve <NUM> because heat shrink <NUM> is removed from the proximal waist <NUM> and bonding sleeve <NUM> once sufficient energy has been applied to reflow the proximal waist <NUM> and bonding sleeve <NUM> into the cross-section view shown in <FIG>. In other words, bonding sleeve <NUM> may melt and/or reflow into the proximal waist <NUM> which includes fibers <NUM> of fiber braid <NUM>. It can be further appreciated the trimming of balloon <NUM> as described in <FIG> may results in cavities, channels, openings and/or spaces existing between fibers <NUM>. Therefore, the cavities, channels, openings and/or spaces may permit the bonding sleeve <NUM> material to wick up one or more fibers <NUM> of braid <NUM>, thereby surrounding, covering, encasing, encapsulating, overlaid and/or sealing the fibers <NUM> within the bonding material <NUM>.

Balloon <NUM> may be pre-formed by radial expansion of a tubular parison, which is optionally also longitudinally stretched. The extruded parison may be radially expanded in a mold or by free-blowing. Alternatively, the parison may be pre-stretched longitudinally before expansion or reformed in various ways to reduce thickness of the balloon cone and waist regions prior to radial expansion. The blowing process may utilize pressurization under tension, followed by rapid dipping into a heated fluid; a sequential dipping with differing pressurization; a pulsed pressurization with compressible or incompressible fluid, after the material has been heated. Heating may also be accomplished by heating the pressurization fluid injected into the parison.

Balloon <NUM> may be formed from balloon materials including compliant, semi-compliant, and non-compliant materials. These materials may include thermoplastic polymers, elastomers, and non-elastomers. Such materials may include low, linear low, medium, and high density polyethylenes, polypropylenes, and copolymers and terpolymers thereof; polyurethanes; polyesters and copolyesters; polycarbonates; polyamides; thermoplastic polyimides; polyetherimides; polyetheretherketones (PEEK) and PES (polyether sulfone); and copolymers and terpolymers thereof. Physical blends and copolymers of such materials may also be used. Examples of polyesters include, but are not limited to, polyethylene terephthalate (PET), polyethylene naphthalate (PEN), polybutylene terephthalate, and copolymers thereof. Examples of polyamides which may be used include nylon <NUM>, nylon <NUM>, nylon <NUM>, nylon <NUM>, nylon <NUM>, nylon <NUM>, nylon <NUM>, nylon <NUM>, nylon <NUM>, nylon <NUM>, nylon <NUM>, and mixtures thereof. Examples of suitable polyurethanes include, but are not limited to, aromatic polyether-based thermoplastic polyurethanes (TPUs) such as those available under the tradename of Tecothane® from Thermedics; thermoplastic polyurethane elastomer available under the tradename of Pellethane®, such as Pellethane® <NUM>-75D from Dow Chemical Co. ; and high strength engineering thermoplastic polyurethane available under the tradename of Isoplast®, such as Isoplast® <NUM> and <NUM> available from Dow Chemical Co.

In some embodiments, the balloon <NUM> may be formed from poly (ether-block-amide) copolymers. The polyamide/polyether block copolymers are commonly identified by the acronym PEBA (polyether block amide). The polyamide and polyether segments of these block copolymers may be linked through amide linkages, or ester linked segmented polymers (e.g., polyamide/polyether polyesters). Such polyamide/polyether/polyester block copolymers are made by a molten state polycondensation reaction of a dicarboxylic polyamide and a polyether diol. The result is a short chain polyester made up of blocks of polyamide and polyether. Polymers of this type are commercially available under the tradename of Pebax® from Arkema. Specific example are the "<NUM>" series polymers with hardness <NUM> and above, Shore D scale, for example, Pebax® <NUM>, <NUM>, and <NUM>. These polymers are made up of nylon <NUM> segments and poly(tetramethylene ether) segments linked by ester groups.

Polyester/polyether segmented block copolymers may also be employed herein. Such polymers are made up of at least two polyester and at least two polyether segments. The polyether segments are the same as previously described for the polyamide/polyether block copolymers useful in the disclosure. The polyester segments are polyesters of an aromatic dicarboxylic acid and a two to four carbon diol.

In some embodiments, the polyether segments of the polyester/polyether segmented block copolymers are aliphatic polyethers having at least <NUM> and no more than <NUM> linear saturated aliphatic carbon atoms between ether linkages. Ether segments may have <NUM>-<NUM> carbons between ether linkages, and can be poly(tetramethylene ether) segments. Examples of other polyethers which may be employed in place of or in addition to tetramethylene ether segments include polyethylene glycol, polypropylene glycol, poly(pentamethylene ether) and poly(hexamethylene ether). The hydrocarbon portions of the polyether may be optionally branched. An example is the polyether of <NUM>-ethylhexane diol. Generally such branches will contain no more than two carbon atoms. The molecular weight of the polyether segments is suitably between about <NUM> and <NUM>,<NUM>, such as between <NUM> and <NUM>.

In some embodiments, the polyester segments of the polyester/polyether segmented block copolymers are polyesters of an aromatic dicarboxylic acid and a two to four carbon diol. Suitable dicarboxylic acids used to prepare the polyester segments of the polyester/polyether block copolymers are ortho-, meta-, or para-phthalic acid, napthalenedicarboxylic acid, or meta-terphenyl-<NUM>,<NUM>'-dicarboxylic acids. Specific examples of polyester/polyether block copolymers are poly(butylene terephthalate)-block-poly(tetramethylene oxide) polymers such as Arnitel® EM <NUM>, sold by DSM Engineering Plastics, and Hytrel® polymers, sold by DuPont, such as Hytrel® <NUM>.

The above lists are intended for illustrative purposes only, and not as a limitation on the present disclosure. It is within purview of those of ordinary skill in the art to select other polymers without departing from the scope of this disclosure.

Balloon <NUM> may be capable of being inflated to relative high pressures. For example, the balloon <NUM> may be inflated to pressures up to about <NUM> atm or more, or up to about <NUM> atm or more, or up to about <NUM> atm or more, or up to about <NUM> atm or more, or up to about <NUM> atm or more, or up to about <NUM> atm or more, or about <NUM>-<NUM> atm, or about <NUM>-<NUM> atm, or about <NUM>-<NUM> atm. At such elevated pressures, the bond between the proximal waist portion <NUM> and the catheter shaft <NUM> (as well as the bond between the distal waist portion <NUM> and the catheter shaft <NUM>) is maintained. Furthermore, the fluid tight bond between the fiber braid <NUM> and the balloon <NUM> is also maintained at these elevated pressures.

In some embodiments, the balloon <NUM> is formed from a compliant material. In some embodiments, the balloon <NUM> is formed from an elastomer, such as a block copolymer elastomer. The block copolymer elastomer may be a poly(ether-block-amide) copolymer. The balloon can also be formed of layers, for example, an inner layer formed of a first polymer material and an outer layer formed from a second polymer material different than the first polymer material. For example, in some embodiments, the inner layer may be formed from an elastomeric polymer material, for example, a block copolymer elastomer, and the outer layer is formed from a non-elastomeric polymer material. In some embodiments, the inner layer is formed of a poly(ether-block-amide) copolymer; and the outer layer is formed of a polyamide.

The fiber braid <NUM> may be formed from a suitable polymer material. General classes of suitable fiber braid materials include, for example, polyesters, polyolefins, polyamides, polyurethanes, liquid crystal polymers, polyimides, and mixtures thereof. More specific examples include, but are not limited to, polyesters such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), and polytrimethylene terephthalate (PTT). Polyamides include nylons and aramids such as Kevlar®. Liquid crystal polymers include Vectran®. Polyolefins include ultrahigh molecular weight polyethylene, such as Dyneema® sold by DSM Dyneema BVm Heerlen, Netherlands, Spectra® fibers, sold by Honeywell, and very high density polyethylene, and polypropylene fibers. Elastomeric fibers can be used in some cases.

In some embodiments, the fiber braid <NUM> comprises an ultra high molecular weight polyethylene (UHMPE). Commercially available UHMPEs include, but are not limited to, Dyneema® fiber available from DSM Dyneema BVm Heerlen, Netherlands, Spectra® fiber available from Honeywell in Morristown and Pegasus UHMWPE fiber available from Pegasus Materials in Shanghai, China. The UHMWPE fibers provide excellent strength and modulus with a small filament size to provide excellent balloon coverage and maintaining a minimal profile. However, when melted, the fibers lose their high molecular orientation and consequently, may also lose their bond tensile strength at the proximal waist portion <NUM> and/or the distal waist portion <NUM> of the balloon <NUM> at a thermal bond interface.

Additionally coatings may be optionally applied to the balloon <NUM>, such as between the outer surface of the balloon <NUM> and the fiber braid <NUM>, over the outer surface of the fiber braid <NUM> or both. In some embodiments, the coating includes a thermoplastic elastomer. In other instances, the coating includes a thermoplastic polyurethane. In some instances, the coating of a thermoplastic polyurethane may be applied to the balloon <NUM> using a suitable technique (e.g., dip coating, spray coating, rolling, or the like) prior to braiding and is also applied to the balloon/braid after braiding.

The catheter shaft <NUM> and/or other parts of catheter system <NUM> (e.g., bonding sleeve <NUM>) may be formed from any suitable shaft material. Examples include, but are not limited to, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-<NUM> (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). For example, the shaft material mixture can contain up to about <NUM> percent LCP. In some embodiments, the catheter shaft <NUM> is formed from a polyamide, for example Grilamid® which is commercially available from EMS-Grivory.

Claim 1:
A catheter assembly, comprising:
a catheter shaft (<NUM>);
a balloon (<NUM>) attached to the catheter shaft (<NUM>), the balloon (<NUM>) including a body (<NUM>) and a proximal waist portion (<NUM>), the proximal waist portion (<NUM>) having a proximal end;
a fiber braid (<NUM>) including one or more individual filaments disposed along the balloon (<NUM>), the fiber braid (<NUM>) having a proximal end aligned with the proximal end of the waist portion (<NUM>); and
a polymer sleeve (<NUM>) disposed on the catheter shaft (<NUM>), wherein the polymer sleeve (<NUM>) abuts the proximal end of the balloon waist and the proximal end of the braid (<NUM>), wherein the polymer sleeve (<NUM>) includes a distal end, and a portion of the distal end of the polymer sleeve (<NUM>) extends into the proximal end of the waist portion.