WO2025259753A1 - Balloon catheters, balloons therefor, and methods for forming balloons - Google Patents

Abstract

A balloon catheter can comprise a shaft (204) and a balloon (318) coupled to a distal end portion of the shaft. The balloon can comprise a main body (280) and one or more pieces of a tape (302) applied to the outer surface (290) of the main body.

Description

BALLOON CATHETERS, BALLOONS THEREFOR, AND METHODS FOR FORMING BALLOONS

CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63/660,307, filed June 14, 2024, which is incorporated by reference herein in its entirety.

FIELD

[0002] The present disclosure relates to balloon catheters for prosthetic medical devices.

BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.

[0004] In some examples, the balloon of the delivery apparatus can tear during an implantation procedure, such as from inadvertent overinflation or puncture caused by contact with the patient’s anatomy. A tear in a lateral or circumferential direction across the balloon can result in a portion of the balloon separating from the balloon catheter and/or the balloon becoming caught on the medical implant being implanted with the delivery apparatus, or on another component of the delivery apparatus when removing the delivery apparatus from a body of a patient.

[0005] Accordingly, a need exists for improved balloons for balloon catheters and methods of fabricating such balloons that can avoid lateral tears if the balloon should fail during a procedure. SUMMARY

[0006] Described herein are balloon catheters for use in medical procedures. The disclosed balloon catheters can, for example, have a greater resistance to punctures and tears. In the event of a rupture, such as may be caused by overinflation, the balloons can be configured to tear in an axial direction under pressure from an inflation pressure received by the balloon, thereby simplifying retrieval and removal of tom balloons from the patient’s body. As such, the devices disclosed herein can, among other things, overcome one or more of the deficiencies of known balloon catheters. In some examples, balloon catheters disclosed herein can comprise delivery apparatuses that are adapted to delivery and deploy a medical implant (for example, a stent or prosthetic valve) inside a patient’s body. In some examples, balloon molds disclosed herein can be configured to form at least a portion (for example, catheter balloons) of any one of the disclosed balloon catheters.

[0007] A balloon catheter can comprise a handle and one or more shafts coupled to the handle.

[0008] In some examples, a balloon catheter can comprise a balloon mounted on a distal end portion of one of the shafts.

[0009] In some examples, the balloon can comprise a main body. In some examples, the main body may have a tapered distal end portion, a tapered proximal end portion, and an intermediate portion extending therebetween.

[0010] In some examples, the balloon can comprise one or more reinforcing members disposed on an outer surface of the main body of the balloon. In some examples, the one or more reinforcing members comprise one or more pieces of tape.

[0011] In some examples, the one or more reinforcing members extend in an axial direction of the balloon. In some examples, the one or more reinforcing members comprises a plurality of axially extending reinforcing members. In some examples, the axially extending reinforcing members are spaced apart from each other in a circumferential direction of the balloon.

[0012] In some examples, the one or more reinforcing members comprise at least one reinforcing member that extends in a circumferential direction of the balloon.

[0013] In some examples, the one or more reinforcing members comprises a first reinforcing member, which covers a distal end portion of the main body and a second reinforcing member, which covers a proximal end portion of the main body. In some examples, the main body of the balloon comprises an intermediate portion between the proximal and distal end portions that is devoid of any reinforcing members. [0014] In some examples, the one or more reinforcing member cover a distal end portion of the main body of the balloon, a proximal end portion of the main body of the balloon, and an intermediate portion of the main body of the balloon.

[0015] In some examples, the one or more pieces of tape comprise a non-elastomeric backing. In some examples, the non-elastomeric backing comprises aluminum.

[0016] In some examples, the one or more pieces of tape comprise a backing comprising a woven fabric.

[0017] In some examples, the one or more pieces of tape comprise a backing comprising cellulose acetate.

[0018] In some examples, the one or more pieces of tape comprise a backing comprising a polyamide.

[0019] In some examples, the one or more pieces of tape comprise a backing comprising aramid fibers.

[0020] In some examples, the one or more pieces of tape comprise a backing comprising an elastomeric material. In some examples, the elastomeric material is selected from the group comprising natural rubber, polyamide, polyurethane, polyethylene, polypropylene, polyester, silicone, polyisoprene, or blends thereof.

[0021] In some examples, the one or more reinforcing members comprise a radiopaque material.

[0022] In some examples, a method for forming a balloon comprises inflating a balloon; and applying one or more pieces of tape to an outer surface of the balloon.

[0023] In some examples the method further comprises the step of cutting the one or more pieces of tape into a desired shape and design prior to applying the one or more pieces of tape to the outer surface of the balloon.

[0024] In some examples, applying one or more pieces of tape to an outer surface of the main body comprises inserting the balloon into an inner cavity of a shrink tube and applying heat to the shrink tube.

[0025] In some examples, applying one or more pieces of tape to an outer surface of the main body comprises applying ultraviolet (UV) radiation to a UV curable adhesive.

[0026] In some examples, the balloon is inflated to a pressure in the range of 5-20 psi while the one or more pieces of tape are applied to the balloon.

[0027] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] FIG. 1 is a side view of a prosthetic heart valve, according to one example.

[0029] FIG. 2 is a side view of a delivery apparatus for a prosthetic heart valve, according to one example.

[0030] FIG. 3A is a side view of a distal end portion of a balloon catheter comprising a balloon shown in a deflated state, according to a first example.

[0031] FIG. 3B is a side view of the distal end portion of the balloon catheter of FIG. 3A showing the balloon in an inflated state.

[0032] FIG. 4 is a is a side view of a distal end portion of a balloon catheter, according to a second example.

[0033] FIG. 5 is a side view of a distal end portion of a balloon catheter, according to a third example.

[0034] FIG. 6 is a side view of a distal end portion of a balloon catheter, according to a fourth example.

[0035] FIG. 7 is a cross section of the distal end portion of the balloon catheter of FIG. 6.

[0036] FIG. 8 is a side view of a distal end portion of a balloon catheter, according to a fifth example.

[0037] FIG. 9 is a cross section of the distal end portion of the balloon catheter of FIG. 8.

[0038] FIG. 10 is a side view of a distal end portion of a balloon catheter, according to a sixth example.

[0039] FIG. 11 is a flowchart depicting the steps of the process of applying reinforcing members to a balloon surface.

DETAILED DESCRIPTION

General Considerations

[0040] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0041] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0042] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and/or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0043] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0044] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of the Disclosed Technology

[0045] Described herein are examples of balloon catheters that can be used in various medical procedures. In some examples, the disclosed balloon catheters can comprise a delivery apparatus that can be used to navigate a subject’s vasculature to deliver an implantable, expandable medical device (for example, a prosthetic heart valve), tools, agents, or other therapy to a location within the body of a subject. Examples of procedures in which the catheters are useful include neurological, urological, gynecological, fertility (for example, in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal, and procedures including access in any body duct or cavity. Particular examples include placing implants, including stents, grafts, embolic coils, and the like; positioning imaging devices and/or components thereof, including ultrasound transducers; and positioning energy sources, for example, for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, and the like. In some examples, the disclosed balloon catheters can be used for performing procedures for opening or widening a blood vessel or heart valve annulus, such as an angioplasty or a valvuloplasty.

[0046] During a medical procedure involving a balloon catheter, the inflatable balloon of the catheter is inflated (such as to deploy a prosthetic valve or another type of implant) by injecting an inflation fluid under pressure into the balloon, and then deflated by withdrawing the inflation fluid from the balloon. Thereafter, the catheter is retracted through an introducer sheath and removed from the patient’s body. A balloon sometimes can rupture or tear during the medical procedure, such as if the balloon is inadvertently overinflated, which can complicate retrieval and removal of the catheter from the patient’s body. For example, if a balloon forms a tear in the circumferential direction, there may be a greater risk of torn portions of the balloon becoming detached from the balloon catheter. Moreover, tearing of the balloon along its proximal end portion while its distal end portion remains intact can cause the distal end portion to retain inflation fluid and/or blood, making it more difficult to retract the balloon into the introducer sheath.

[0047] To address one or more problems of known balloons, it would be desirable to control how a balloon ruptures when subjected to overinflation. For example, it would be desirable to design a balloon such that if it is subjected to overinflation and rupture occurs, the balloon will form one or more axially extending tears.

Examples of the Disclosed Technology

[0048] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0049] FIG. 1 shows an exemplary prosthetic valve 100, according to one example. Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries, and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0050] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017/0231756, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020/247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019/0000615, which is incorporated herein by reference.

[0051] The prosthetic valve 100 can comprise a frame 112, a valvular structure 114, an inner skirt 116, and a perivalvular outer sealing member or outer skirt 118. The prosthetic valve 100 can comprise an inflow end portion 115 and an outflow end portion 119, and an intermediate portion 117 extending therebetween.

[0052] The valvular structure 114 can comprise a plurality of leaflets 140 collectively forming a leaflet structure. In some examples, the valvular structure 114 can comprise three leaflets 140 arranged in a tricuspid arrangement. However, there can be a greater or fewer number of leaflets 140. The leaflets can be secured to one another at their adjacent sides to form commissures 122 of the valvular structure 114. The lower edge of the valvular structure 114 can have an undulating, curved scalloped shape, and can be secured to the inner skirt 116 by sutures (not shown). In some examples, the leaflets 140 can be formed of pericardial tissue (such as bovine pericardial tissue), biocompatible synthetic materials, or other various suitable natural or synthetic materials as known in the art and described in U.S. Patent Number 6,730,118, which is incorporated by reference herein.

[0053] The frame 112 can be made of any of various suitable plastically -expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol) as known in the art. When constructed of a plastically-expandable material, the frame 112 (and thus the valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 112 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0054] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 112) include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 112 can comprise stainless steel. In some examples, the frame 112 can comprise cobalt-chromium. In some examples, the frame 112 can comprise nickel-cobalt- chromium. In some examples, the frame 112 comprises a nickel-cobalt-chromium- molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™/UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0055] The inner skirt 116 and/or the outer skirt 118 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the skirts 116, 118 can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the skirts 116, 118 can comprise a fabric without interlaced yarns or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the skirts 116, 118 can comprise a non-textile or non- fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the skirts 116, 118 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the skirts 116, 118 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

Delivery Apparatus

[0056] FIG. 2 shows a delivery apparatus 200, according to one example, in the form of a balloon catheter that can be used to implant a prosthetic medical device. In some examples, the delivery apparatus 200 can be used to implant an expandable prosthetic heart valve (for example, the prosthetic heart valve 100 of FIG. 1 and/or any of the other prosthetic heart valves described herein). In some examples, the delivery apparatus 200 is specifically adapted for use in introducing a prosthetic heart valve into a heart.

[0057] The delivery apparatus 200 in the illustrated example of FIG. 2 comprises a handle 202 and a steerable, outer shaft 204 extending distally from the handle 202. The delivery apparatus 200 can further comprise an intermediate shaft 206 (which also may be referred to as a balloon shaft) that extends proximally from the handle 202 and distally from the handle 202, the portion extending distally from the handle 202 also extending coaxially through the outer shaft 204. Additionally, the delivery apparatus 200 can further comprise an inner shaft 208 extending distally from the handle 202 coaxially through the intermediate shaft 206 and the outer shaft 204 and proximally from the handle 202 coaxially through the intermediate shaft 206.

[0058] The outer shaft 204 and the intermediate shaft 206 can be configured to translate (for example, move) longitudinally, along a central longitudinal axis 220 of the delivery apparatus 200, relative to one another to facilitate delivery and positioning of a prosthetic heart valve at an implantation site in a patient’s body.

[0059] The intermediate shaft 206 can include a proximal end portion 210 that extends proximally from a proximal end of the handle 202, to an adaptor 212. A rotatable knob 214 can be mounted on the proximal end portion 210 and can be configured to rotate the intermediate shaft 206 around the central longitudinal axis 220 and relative to the outer shaft 204. [0060] The adaptor 212 can include a first port 238 configured to receive a guidewire therethrough and a second port 240 configured to receive fluid (for example, inflation fluid) from a fluid source. The second port 240 can be fluidly coupled to an inner lumen of the intermediate shaft 206.

[0061] The intermediate shaft 206 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 204 when a distal end of the outer shaft 204 is positioned away from an inflatable balloon 218 (which also referred to herein as a “catheter balloon”) of the delivery apparatus 200. A distal end portion of the inner shaft 208 can extend distally beyond the distal end portion of the intermediate shaft 206.

[0062] The balloon 218 can be coupled to the distal end portion of the intermediate shaft 206.

[0063] In some examples, a distal end of the balloon 218 can be coupled to a distal end of the delivery apparatus 200, such as to a nose cone 222 (as shown in FIG. 2), or to an alternate component at the distal end of the delivery apparatus 200 (for example, a distal shoulder). An intermediate portion of the balloon 218 can overlay a valve mounting portion 224 of a distal end portion of the delivery apparatus 200 and a distal end portion of the balloon 218 can overly a distal shoulder 226 of the delivery apparatus 200. The valve mounting portion 224 and the intermediate portion of the balloon 218 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG. 2, a prosthetic heart valve (which can be one of the prosthetic heart valves described herein) can be mounted around the balloon 218, at the valve mounting portion 224 of the delivery apparatus 200.

[0064] The balloon shoulder assembly, including the distal shoulder 226, is configured to maintain the prosthetic heart valve 250 (or other prosthetic medical device) at a fixed position on the balloon 218 during delivery through the patient’s vasculature.

[0065] The outer shaft 204 can include a distal tip portion 228 mounted on its distal end. The outer shaft 204 and the intermediate shaft 206 can be translated axially relative to one another to position the distal tip portion 228 adjacent to a proximal end of the valve mounting portion 224, when the prosthetic heart valve 250 is mounted in the radially compressed state on the valve mounting portion 224 (as shown in FIG. 2) and during delivery of the prosthetic heart valve to the target implantation site. As such, the distal tip portion 228 can be configured to resist movement of the prosthetic heart valve 250 relative to the balloon 218 proximally, in the axial direction, relative to the balloon 218, when the distal tip portion 228 is arranged adjacent to a proximal side of the valve mounting portion 224. [0066] An annular space can be defined between an outer surface of the inner shaft 208 and an inner surface of the intermediate shaft 206 and can be configured to receive fluid from a fluid source via the second port 240 of the adaptor 212. The annular space can be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 208 and an inner surface of the balloon 218. As such, fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the balloon 218 and radially expand and deploy the prosthetic heart valve 250.

[0067] An inner lumen of the inner shaft can be configured to receive a guidewire therethrough, for navigating the distal end portion of the delivery apparatus 200 to the target implantation site.

[0068] The handle 202 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 200. In the illustrated example, for example, the handle 202 includes an adjustment member, such as the illustrated rotatable knob 260, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 202 through the outer shaft 204 and has a distal end portion affixed to the outer shaft 204 at or near the distal end of the outer shaft 204. Rotating the knob 260 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 200. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein.

[0069] The handle 202 can further include an adjustment mechanism 261 including an adjustment member, such as the illustrated rotatable knob 262, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 278. The adjustment mechanism 261 is configured to adjust the axial position of the intermediate shaft 206 relative to the outer shaft 204 (for example, for fine positioning at the implantation site). Further details on the delivery apparatus 200 can be found in PCT Publication No. WO2022/046585, which is incorporated by reference herein.

[0070] FIGS. 3A-3B show a side view of the balloon 218, according to one example. The balloon 218 can comprise an inflatable main body 280 configured to be inflatable between a deflated state (FIG. 3A) and an inflated state (FIG. 3B). The main body 280 can comprise a proximal end portion 282, a distal end portion 286 distally disposed relative to the proximal end portion 282, and an intermediate portion 284 extending therebetween. In some examples, at least one of the proximal end portion 282 and the distal end portion 286 of the balloon 218 can be tapered. In some examples, at least one of the proximal end portion 282 and the distal end portion 286 of the balloon 218 can comprise a frustoconical shape that tapers away from the intermediate portion 284. The proximal end portion 282 can be coupled to a shaft (such as the intermediate shaft 206) of the delivery apparatus 200. The intermediate portion 284 can be configured to receive a prosthetic heart valve (such as the prosthetic heart valve 100) in a radially compressed state. The distal end portion 286 can be connected to the nose cone 222 or another distal end component of the delivery apparatus 200 (such as a distal shoulder). In some examples, the proximal end portion 282, the intermediate portion 284, and the distal end portion 286 can he integrally formed as a single component.

[0071] The main body 280 can further comprise an inner surface 270 (this is best shown in FIGS. 7 and 9 with respect to balloon 518 and balloon 618 respectively, but it should be understood that the other balloons described herein have a similar inner surface 270) that defines an interior of the balloon 218 and an outer surface 290 disposed radially outward of the inner surface. The inner surface 270 can define an inner cavity of the main body 280 that is configured to receive an inflation fluid for inflating the main body 280 when the balloon 218 is mounted to the delivery apparatus 200.

[0072] In some examples, it is desirable to reinforce the balloon with a reinforcing material, such as for example strips of a material. This reinforcing material can increase the surface tension of the balloon and prevent or minimize tears from propagating once the balloon fails due to puncture or excessive pressure. It is often desirable to use as little reinforcing material as possible (for example, using a thin layer of material and/or only partially covering the balloon) so as to alter balloon properties as little as possible. In some instances, a relatively thin material may be desirable to minimize the overall crimp profile of the uninflated balloon and a prosthetic valve radially crimped around the balloon. As a further consideration, it is desirable to select a material that can minimize friction and particulate generation. Additionally, in some instances, it may be desirable to achieve this reinforcement while avoiding modifying the existing balloon material.

[0073] To such ends, a balloon, for example, one similar to the balloon 218 depicted in FIG. 3A-3B may be reinforced with one or more pieces of material, such as in the forms of strips of material and/or reinforcing members. In some examples, this material can be tape. As used herein, the term “tape” refers to a structure comprising a backing (also referred to as a “carrier”) and an adhesive layer disposed on the backing. In some examples, the tape may comprise a backing with a pre-applied adhesive layer, meaning that the adhesive layer is disposed on the backing prior to the tape being applied to a balloon. In some examples, the adhesive layer may be applied to the backing as a part of the tape application process (when the tape is applied to a balloon).

[0074] In some examples, the tape backing may be a non-elastomeric material. In some examples, the non-elastomeric material can be metal or metal alloy, such as aluminum or a polymer, such as cellulose acetate (such as the backing for Scoth® tape), or a polyimide (such as the backing for Kapton® tape). In some examples, the backing can be a fabric (such as a woven, braided, or knitted fabric). The fabric can comprise woven, braided or knitted fibers made from any of various materials, such as aramid fibers (similar to Kevlar® tape) or carbon fibers. In some examples, the tape backing may be an elastomeric material, such as natural rubber or any of various synthetic elastomers, including, for example, polyamide (such as Nylon), polyurethane, polyethylene (such as Low Density Polyethylene (LDPE), High Density Polyethylene (HDPE), Ultra-High Molecular Weight Polyethylene (UHMWPE)), polypropylene, polyesters (such as polyethylene terephthalate (PET)), silicone, or polyisoprene, to name a few. In some examples, the backing may comprise a combination of two or more of the above materials. In some examples the combination can comprise a physical blending of two or more of the polymers listed above. In some examples, the combination can comprise a chemical co-polymerization. In some such examples, the combination can comprise backing which comprises two or more layers made of different materials.

[0075] Conventional balloons by themselves are not visible or are barely perceptible under fluoroscopy. Typically, balloons are inflated with a contrast solution to enable visualization of the balloon under fluoroscopy during a medical procedure. In some examples, the reinforcing member or the tape backing can comprise a radiopaque material. For example, the backing can comprise a polymer (such as any of the polymers listed above) mixed with a radiopaque powder. If the backing comprises a metal or metal alloy, the backing is inherently radiopaque. In some examples, the reinforcing member or the tape can include an additional radiopaque layer. Including a radiopaque material in the backing can have the advantage of increasing the visibility of the balloon under fluoroscopy during the implantation procedure. Thus, in some examples, when the balloon includes a reinforcing member that includes a radiopaque material, the balloon can be inflated with a clear inflation fluid (such as saline or sterile water) instead of a contrast solution.

[0076] In some examples, the material may be a heat shrink tube or heat shrink material, which is used as a backing, and the adhesive may be applied to the inner surface of the shrink tube. In this example, heat is applied to the shrink tube which results in the shrink tube shrinking and the adhesive coming into contact with the outer surface of the balloon. In some examples, the shrink tube material may comprise a thermoplastic elastomer (for example, Pebax), Teflon, polyethylene, or polyethylene terephthalate (PET).

[0077] In some examples the adhesive can comprise an epoxy such as nylon-phenolic, nitrile-phenolic, nitriles, neoprene, modified epoxy, cyanoacrylate, modified phenolic, resorcinol-formaldehyde, or polyurethane. In some examples, the adhesive can be an ultraviolet (UV) curable adhesive. In some examples, the UV curable adhesive is Dymax MD® 215-CTH-UR-SC.

[0078] FIGS. 4-10 show several balloon catheters having reinforced balloons, according to some examples. The catheters of FIGS. 4-10 can be a delivery apparatus for implanting a medical device in a patient’s body (for example, the delivery apparatus 200) or a balloon catheter that is used for performing various other medical procedures. Common components of the balloon 218 and the balloons in the below examples are given the same reference numbers in FIGS. 4-10. In some examples, the balloons described below are the same as the balloon 218 except for the differences described below. For example, the examples described below can include an intermediate shaft 206, a balloon proximal end portion 282, a balloon intermediate portion 284, a balloon distal end portion 286, etc., and these components should be understood to be the same as described with respect to the delivery apparatus 200. However, it should be noted that the balloon catheters described below need not include all of the components described above for the delivery apparatus 200.

[0079] FIG. 4 shows a side view of a balloon catheter comprising a second example of a balloon 318 comprising a main body 280 and a plurality of reinforcing members 302 (also referred to as “support strips” and/or “reinforcing members”) disposed on the outer surface 290 of the main body 280. In some examples, the reinforcing members are one or more pieces of tape. In the depicted example, the reinforcing members 302 extend in an axial direction of the balloon, that is, from the intermediate shaft 206 to the nose cone 222. Each of the reinforcing members 302 at least along the intermediate portion 284 can extend parallel to a longitudinal axis of the balloon and the balloon catheter. In some examples, the reinforcing members can extend in an axial direction at an angle greater than zero relative to the longitudinal axis of the balloon, such as a 45 -degree angle with respect to the axis of the balloon. In the depicted example, there are six reinforcing members 302 (three reinforcing members 302 are on the opposite side of the balloon and therefore not shown) which are equally spaced around the circumference of the balloon 318. In some examples, there may be fewer members or more members. This configuration has the advantage of using a small amount of material and imposing minimum circumferential constraints on the expansion of the balloon. Furthermore, this design has the advantage of inhibiting tears from propagating around the balloon in the circumferential direction.

[0080] In some examples, the reinforcing members 302 may be unequally spaced in the circumferential direction such that the spacing between adjacent strips can vary around the balloon. In the illustrated example, each reinforcing member 302 extends continuously from the proximal end portion 282 to the distal end portion 286 such that each member extends across an entire extent of the balloon at that location. In some examples, one or more of the members can extend across only a portion of the balloon (for example, along the proximal end portion 282, the intermediate portion 284, the distal end portion 286, or portions thereof). In some examples, the balloon can include members that are circumferentially aligned along the length of the balloon but axially spaced from each other so as to define axially extending gaps between adjacent ends of the adjacent members.

[0081] FIG. 5 shows another example of a balloon catheter comprising a balloon 418 with a plurality of reinforcing members. In the depicted example, a plurality of reinforcing members 402 extend in the axial direction. Each of the reinforcing member 402 can extend parallel to the longitudinal axis of the balloon at least along the intermediate portion 284. One exemplary difference between the balloon 418 and the balloon 318 is that in addition to the axially extending reinforcing members 402, there are one or more circumferential reinforcing members 404, which extend in a circumferential direction of the balloon.

[0082] In some examples, these circumferential reinforcing members 404 extend around the entire circumference of the balloon. In some examples, these circumferential reinforcing members 404 may extend around portions of the circumference of the balloon. In the depicted example, there are two reinforcing members 404, including a first circumferential reinforcing member 404a positioned where the proximal end portion 282 and the intermediate portion 284 meet and a second circumferential reinforcing member 404b positioned where the distal end portion 286 and the intermediate portion 284 meet. In other examples, a greater or fewer number of circumferential reinforcing members 404 equally spaced and/or unequally spaced along the length of the balloon and positioned at any locations along the length of the balloon. In some examples, each of the proximal end portion 282, the intermediate portion 284, and the distal end portion 286 can include any number of circumferential reinforcing members 404. Also, the reinforcing members 402, 404 are depicted as lines in FIG. 5. It should be noted that the width of each reinforcing members 402, 404 can be varied for a particular application. [0083] Similar to the balloon 318, the balloon 418 has the advantage of using a small amount of material and imposing minimum circumferential constraints on the expansion of the balloon. Also, like balloon 318, this design has the advantage of inhibiting tears from propagating around the balloon in the circumferential direction. Additionally, 418 has the advantage of inhibiting tears which form in the intermediate portion 284 from propagating to either the proximal end portion 282 or the distal end portion 286.

[0084] FIG. 6 depicts a fourth example of a balloon catheter comprising a balloon 518 with reinforcing member 502 covering the outer surface of the main body 280 at the proximal end portion 282 and reinforcing member 504 covering the outer surface of the main body 280 at the distal end portion 286. FIG. 7 depicts a cross section of the balloon 518. In the depicted example, the reinforcing member 502 and reinforcing member 504 each comprise one continuous reinforcing member, with the member 502 covering the entire tapered proximal end portion 282 and the member 504 covering the entire tapered distal end portion 286. However, in some examples, member 502 and/or member 504 may be made up of a plurality of members, may provide discontinuous coverage of the proximal end portion 282 and the distal end portion 286 respectively, and/or may cover less than an entire extent of the proximal end portion 282 or the distal end portion 286.

[0085] This configuration has the advantage of minimal interaction between the members 502, 504 and the expandable medical implant (such as the prosthetic valve 250), because the medical implant is disposed around the intermediate portion 284. Furthermore, in this specific example, it provides full coverage of the exposed portion balloon (the “exposed’' portion of the balloon being the portion not covered by the medical implant at the proximal end portion 282 and the distal end portion 286) to resist puncture propagation. Finally, the constraint placed on the proximal end portion 282 and the distal end portion 286 by the members 502 in this example can increase the burst pressure of the balloon while forcing the balloon to inflate more evenly along the length of the balloon while expanding the prosthetic valve 250 (or another medical implant).

[0086] FIG. 8 depicts a fifth example of a balloon catheter comprising a balloon 618 with reinforcing member 602 covering the outer surface of the intermediate portion 284 as well as the outer surfaces of the tapered surface of the proximal end portion 282 and the distal end portion 286 of the main body 280. Thus, in this example, the reinforcing member 602 covers the entirety of the outer surface of the inflatable portion of the balloon. FIG. 9 depicts a cross section of the balloon 618. This configuration provides full coverage of balloon to resist puncture propagation along the entire balloon. Furthermore, the constraint on the entire outer surface 290 of the balloon 618 may increase burst pressure.

[0087] FIG. 10 depicts a sixth example of a balloon catheter comprising a balloon 718. The balloon 718 comprises an inner balloon 702, one or more strips of tape 704, and an outer balloon 706 encompassing or covering the inner balloon 702 and the tape 704. In some examples, the tape 704 is adhered to an outer surface 290 of the inner balloon 702 such that it expands with the inflation of the inner balloon 702. In some examples, the tape 704 is single sided tape and only adhered to the outer surface 290 of the inner balloon 702. In some examples, the outer balloon 706 is not adhered to or otherwise attached to the inner balloon 702. In some examples, the tape 704 is double sided tape (a tape comprising a backing or carrier with an adhesive layer on each side of the carrier) and is adhered to the inner surface of the outer balloon 706 as well as to the outer surface of the inner balloon 702.

[0088] In the illustrated example, there is a single piece of tape 704 that is sized to cover the intermediate portion 284 of the inner balloon 702. In some examples, the tape 704 can be replaced with any arrangement of one or more pieces of tape, such as any of those shown in FIGS. 4-9, wherein the tape can be single-sided or double-sided.

[0089] This example has the advantage of increasing burst pressure and inhibiting tears from propagating along or around the balloon. Furthermore, the addition of the outer balloon has the added advantage of minimizing or eliminating any interaction between the tape 704 and the expandable medical implant (such as the prosthetic valve 250).

[0090] In some examples, the balloon 718 can omit the outer balloon 706.

[0091] FIG. 11 is a flowchart of an exemplary method 1100 for applying reinforcing member, such as tape, to a balloon surface. It should be understood that any of the processes described below can be used to form any of the balloons disclosed in this application, such as for example any of the balloons depicted in FIGS. 4-10. Any of the resulting balloons can be used with a balloon catheter, such as a delivery apparatus, for example, the delivery apparatus 200.

[0092] Method 1100 begins at 1102 by forming a balloon main body (for example, a balloon main body 280 of FIG. 3A-3B). For example, the balloon main body may be formed using a blow molding process in which a parison is placed inside a mold and inflated under heat and pressure. Other conventional methods of manufacturing balloons may be used. In other examples, premanufactured balloons may be used. After the balloon main body has been formed, the main body is inflated, desirably to a low pressure at 1104. In some examples, the balloon is inflated such that there are no folds in the outer surface of the balloon, in other words such that the outer surface of the balloon is smooth. In some examples, the balloon main body is inflated to a pressure in the range of 5-20 psi.

[0093] At 1106, the method can include the optional step of applying an adhesive to a reinforcing member. In some examples, the method includes applying an adhesive to a backing to form a tape. In some examples, the backing is a shrink tube and step 1106 comprises coating an inside surface of the shrink tube material with an adhesive. In other examples, the tape is prefabricated and has adhesive that is already applied to the backing material, in which case step 1 106 may be omitted.

[0094] At step 1108, the method includes applying the reinforcing member to the balloon. In some examples, 1108 comprises applying the reinforcing member to the outer surface 290 of the main body of the balloon. In some examples, this step may comprise a user manually applying the reinforcing member to the main body of the balloon. In some examples, the reinforcing member may be fed into a machine, such as a machine with a robotic arm, that applies the reinforcing member to the balloon. In some examples, the reinforcing member is a heat shrink tube, and this step comprises inserting the balloon into an inner cavity of the shrink tube. In the case of a shrink tube being used, the method includes the optional step of applying heat to the heat shrink tube at 1110. Applying heat to the heat shrink tube results in the heat shrink tube shrinking and the tape being applied to the balloon main body previously inserted into the inner cavity. In some examples, an adhesive layer is provided on an inner surface of the shrink tube and applying heat to the shrink tube adhesively bonds the shrink tube to the outer surface of the main body of the ballon. In the case of a UV curable adhesive, the method includes the optional step of applying UV radiation to a UV curable adhesive on an inner surface of the one or more reinforcing members and contacting the outer surface of the main body of the balloon.

[0095] It should be understood that in addition to the examples of methods of applying reinforcing members to balloons given above, the reinforcing members can be applied in other ways during and/or after the formation of the balloon. In some examples, the balloon may be formed using a blow molding process in which a parison is placed inside a mold and inflated. One or more reinforcing members, such as pieces of tape, may be positioned on the inner surface with a non-adhesive side radially outward and an adhesive side radially inward; and inflating the parison within the mold causes an outer surface of the parison to contact the inner surface of the mold and the adhesive side of the tape.

[0096] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat/thermal, pressure, steam, radiation, and/or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat/thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. Delivery Techniques

[0097] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (for example, by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand).

Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0098] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve. [0099] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve/pulmonary artery.

[0100] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0101] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

Additional Examples of the Disclosed Technology

[0102] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0103] Example 1. A balloon catheter comprising: a shaft having a proximal end portion and a distal end portion; and an inflatable balloon mounted on the distal end portion of the shaft, the balloon comprising: a main body; and one or more reinforcing members disposed on an outer surface of the main body of the balloon.

[0104] Example 2. The balloon catheter of any example herein, particularly example 1, wherein the one or more reinforcing members comprise one or more pieces of tape. [0105] Example 3. The balloon catheter of any example herein, particularly any one of examples 1-2, wherein the one or more reinforcing members extend in an axial direction of the balloon.

[0106] Example 4. The balloon catheter of any example herein, particularly example 3, wherein the one or more reinforcing members comprise a plurality of axially extending reinforcing members.

[0107] Example 5. The balloon catheter of any example herein, particularly example 4, wherein the axially extending reinforcing members are spaced apart from each other in a circumferential direction of the balloon.

[0108] Example 6. The balloon catheter of any of any example herein, particularly any one of examples 1-5, wherein the one or more reinforcing members comprise at least one reinforcing member that extends in a circumferential direction of the balloon.

[0109] Example 7. The balloon catheter of any example herein, particularly example 1-2, wherein the one or more reinforcing members comprises a first reinforcing member which covers a distal end portion of the main body and a second reinforcing member which covers a proximal end portion of the main body.

[0110] Example 8. The balloon catheter of any example herein, particularly example 7, wherein the main body of the balloon comprises an intermediate portion between the proximal end portion and the distal end portion that is devoid of any reinforcing members. [0111] Example 9. The balloon catheter of any example herein, particularly example 1-2, wherein the one or more reinforcing members cover a distal end portion of the main body of the balloon, a proximal end portion of the main body of the balloon, and an intermediate portion of the main body of the balloon.

[0112] Example 10. The balloon catheter of any example herein, particularly example 2 or any one of examples 3-9, when dependent upon example 2, wherein the one or more pieces of tape comprise a non-elastomeric backing.

[0113] Example 11. The balloon catheter of any example herein, particularly example 10, wherein the non-elastomeric backing comprises aluminum.

[0114] Example 12. The balloon catheter of any example herein, particularly example 2 or any one of examples 3-9, when dependent upon example 2, wherein the one or more pieces of tape comprise a backing comprising a woven fabric.

[0115] Example 13. The balloon catheter of any example herein, particularly example 2 or any one of examples 3-9, when dependent upon example 2, wherein the one or more pieces of tape comprise a backing comprising cellulose acetate. [0116] Example 14. The balloon catheter of any example herein, particularly example 2 or any one of examples 3-9, when dependent upon example 2, wherein the one or more pieces of tape comprise a backing comprising a polyamide.

[0117] Example 15. The balloon catheter of any example herein, particularly example 2 or any one of examples 3-9, when dependent upon example 2, wherein the one or more pieces of tape comprise a backing comprising aramid fibers.

[0118] Example 16. The balloon catheter of any example herein, particularly example 2 or any one of examples 3-9, when dependent upon example 2, wherein the one or more pieces of tape comprise a backing comprising an elastomeric material.

[0119] Example 17. The balloon catheter of any example herein, particularly example 16, wherein the elastomeric material is selected from the group comprising natural rubber, polyamide, polyurethane, polyethylene, polypropylene, polyester, silicone, polyisoprene, or blends thereof.

[0120] Example 18. The balloon catheter of any example herein, particularly any one of examples 1-17, wherein the one or more pieces of tape comprise a radiopaque material. [0121] Example 19. A balloon catheter comprising: a shaft having a proximal end portion and a distal end portion; and an inflatable balloon mounted on the distal end portion of the shaft, the balloon comprising: a main body; and a plurality of strips of tape adhered to an outer surface of the main body of the balloon.

[0122] Example 20. The balloon catheter of any example herein, particularly example 19, wherein the strips of tape of the plurality of strips of tape extend in an axial direction of the balloon.

[0123] Example 21. The balloon catheter of any example herein, particularly any one of examples 19-20, wherein the plurality of strips of tape are spaced apart from each other in a circumferential direction of the balloon.

[0124] Example 22. The balloon catheter of any of any example herein, particularly any one of examples 19-21, wherein the plurality of strips of tape comprises at least one strip of tape that extends in a circumferential direction of the balloon.

[0125] Example 23. The balloon catheter of any example herein, particularly any one of examples 19-22, wherein the plurality of strips comprises a non-elastomeric material.

[0126] Example 24. The balloon catheter of any example herein, particularly example 22, wherein the non-elastomeric material comprises aluminum. [0127] Example 25. The balloon catheter of any example herein, in particular any one of examples 19-22, wherein the plurality of strips comprises a material comprising a woven fabric.

[0128] Example 26. The balloon catheter of any example herein, particularly any one of examples 19-22, wherein the plurality of strips comprises a material comprising cellulose acetate.

[0129] Example 27. The balloon catheter of any example herein, particularly any one of examples 19-22, wherein the plurality of strips comprises a material that is a polyamide. [0130] Example 28. The balloon catheter of any example herein, particularly any one of examples 19-22, wherein the plurality of strips comprises a material that is aramid fibers. [0131] Example 29. The balloon catheter of any example herein, particularly any one of examples 19-22, wherein the plurality of strips comprises an elastomeric material.

[0132] Example 30. The balloon catheter of any example herein, particularly any one of examples 19-29, wherein the plurality of strips comprises a radiopaque material.

[0133] Example 31. A balloon catheter comprising: a shaft having a proximal end portion and a distal end portion; an inflatable first balloon mounted on the distal end portion of the shaft, the first balloon comprising: a main body; and one or more pieces of tape disposed on an outer surface of the main body of the first balloon; and a second balloon, wherein the second balloon extends over the first balloon and the one or more pieces of tape.

[0134] Example 32. The balloon catheter of any example herein, particularly example 31, wherein the main body of the first balloon comprises an intermediate portion between a distal end portion of the main body and a proximal end portion of the main body and the tape is covers the intermediate portion.

[0135] Example 33. The balloon catheter of any example herein, particularly any one of examples 31-32, wherein the one or more pieces of tape comprise a non-elastomeric backing. [0136] Example 34. The balloon catheter of any example herein, particularly example 33, wherein the non-elastomeric backing comprises aluminum.

[0137] Example 35. The balloon catheter of any example herein, particularly any one of examples 31-32, wherein the one or more pieces of tape comprise a backing comprising a woven fabric.

[0138] Example 36. The balloon catheter of any example herein, particularly any one of examples 31-32, wherein the one or more pieces of tape comprise a backing comprising cellulose acetate. [0139] Example 37. The balloon catheter of any example herein, particularly any one of examples 31-32, wherein the one or more pieces of tape comprise a backing comprising a polyamide.

[0140] Example 38. The balloon catheter of any example herein, particularly any one of examples 31-32, wherein the one or more pieces of tape comprise a backing comprising aramid fibers.

[0141] Example 39. The balloon catheter of any example herein, particularly any one of examples 31 -32, wherein the one or more pieces of tape comprise an elastomeric backing. [0142] Example 40. The balloon catheter of any example herein, particularly any one of examples 31-39, wherein the one or more pieces of tape comprise a radiopaque material. [0143] Example 41. A method of forming a balloon comprising: inflating a main body of a balloon; and applying one or more reinforcing members to an outer surface of the main body. [0144] Example 42. The method of any example herein, particularly example 41, further comprising the step of cutting the one or more reinforcing members into a desired shape prior to applying the one or more reinforcing members to the main body.

[0145] Example 43. The method of any example herein, particularly example 41, wherein applying one or more reinforcing members to an outer surface of the main body comprises inserting the balloon into an inner cavity of a shrink tube having an adhesive layer and applying heat to the shrink tube to adhesively bond the shrink tube to the outer surface of the main body of the balloon such that the shrink tube forms one of the one or more reinforcing members.

[0146] Example 44. The method of any example herein, particularly example 41, wherein applying one or more reinforcing members to an outer surface of the main body comprises applying ultraviolet (UV) radiation to a UV curable adhesive on an inner surface of the one or more reinforcing members and contacting the outer surface of the main body of the balloon. [0147] Example 45. The method of any example herein, particularly any one of examples 41- 44, wherein the balloon is inflated to a pressure of 5-20 psi.

[0148] Example 46. The method of any example herein, particularly any one of examples 41-45, wherein the one or more reinforcing members comprises one or more pieces of tape. [0149] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one balloon can be combined with any one or more features of another balloon. As another example, any one or more features of one delivery apparatus and/or medical implant can be combined with any one or more features of another delivery apparatus and/or medical implant.

[0150] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

Claims:

1. A balloon catheter comprising: a shaft having a proximal end portion and a distal end portion; and an inflatable balloon mounted on the distal end portion of the shaft, the balloon comprising: a main body; and one or more pieces of tape disposed on an outer surface of the main body of the balloon.

2. The balloon catheter of claim 1, wherein the one or more pieces of tape extend in an axial direction of the balloon.

3. The balloon catheter of any one of claims 1-2, wherein the one or more pieces of tape comprise a plurality of axially extending pieces of tape and the plurality of axially extending pieces of tape are spaced apart from each other in a circumferential direction of the balloon.

4. The balloon catheter of any of claims 1-3, wherein the one or more pieces of tape comprise at least one piece of tape that extends in a circumferential direction of the balloon.

5. The balloon catheter of claim 1, wherein the one or more pieces of tape comprise a first piece of tape which covers a distal end portion of the main body and a second piece of tape which covers a proximal end portion of the main body and wherein the main body of the balloon comprises an intermediate portion between the proximal end portion and the distal end portion that is devoid of any pieces of tape.

6. The balloon catheter of claim 1, wherein the one or more pieces of tape cover a distal end portion of the main body of the balloon, a proximal end portion of the main body of the balloon, and an intermediate portion of the main body of the balloon.

7. The balloon catheter of any one of claims 1-6, wherein the one or more pieces of tape comprise a non-elastomeric backing.

8. The balloon catheter of any one of claims 1-6, wherein the one or more pieces of tape comprise a backing comprising a fabric.

9. The balloon catheter of any one of claims 1-6, wherein the one or more pieces of tape comprise a backing comprising aramid fibers.

10. The balloon catheter any one of claims 1-6, wherein the one or more pieces of tape comprise a backing comprising an elastomeric material.

11. A balloon catheter comprising: a shaft having a proximal end portion and a distal end portion; an inflatable first balloon mounted on the distal end portion of the shaft, the first balloon comprising: a main body; and one or more pieces of tape disposed on an outer surface of the main body of the first balloon; and a second balloon, wherein the second balloon extends over the first balloon and the one or more pieces of tape.

12. The balloon catheter of claim 11, wherein the main body of the first balloon comprises an intermediate portion between a distal end portion of the main body and a proximal end portion of the main body and the tape covers the intermediate portion.

13. The balloon catheter of any one of claims 11-12, wherein the one or more pieces of tape comprise a non-elastomeric backing.

14. The balloon catheter of any one of claims 11-12, wherein the one or more pieces of tape comprise a backing comprising a fabric.

15. The balloon catheter of any one of claims 11-12, wherein the one or more pieces of tape comprise an elastomeric backing.

16. A method of forming a catheter balloon comprising: inflating a main body of a balloon; and applying one or more reinforcing members to an outer surface of the main body.

17. The method of claim 16, further comprising the step of cutting the one or more reinforcing members into a desired shape prior to applying the one or more reinforcing members to the main body.

18. The method of claim 16, wherein applying one or more reinforcing members to an outer surface of the main body comprises inserting the balloon into an inner cavity of a shrink tube having an adhesive layer and applying heat to the shrink tube to adhesively bond the shrink tube to the outer surface of the main body of the balloon such that the shrink tube forms one of the one or more reinforcing members.

19. The method of claim 16, wherein applying one or more reinforcing members to an outer surface of the main body comprises applying ultraviolet (UV) radiation to a UV curable adhesive on an inner surface of the one or more reinforcing members and contacting the outer surface of the main body of the balloon.

20. The method of any one of claims 16-20, wherein the one or more reinforcing members comprise one or more pieces of tape.