Balloons for medical devices

Abstract

Inflatable balloons for medical devices are disclosed, wherein the balloons can withstand higher pressures and have improved shape control during expansion. The inflatable balloons (302a) have a wall comprising a first layer (320), a second layer (322) radially outward of the first layer, and a third layer (324) radially outward of the second layer, wherein the first layer and the third layer are not thermally bondable to the second layer. The balloons can comprise first and second end caps (342, 344), the first end cap being bonded to the first and third layers at a first end of the wall, and the second end cap being bonded to the first and the third layers at a second end of the wall. The walls at both ends are thereby sealed, encapsulating the second layer within and enabling the ends to withstand higher pressures. The balloons are further bonded to a delivery device (300).

Description

BALLOONS FOR MEDICAL DEVICES CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No.63 / 567,755, filed March 20, 2024, which is incorporated by reference herein in its entirety. FIELD

[0002] The present disclosure relates to inflatable balloons for medical devices, for example, delivery apparatuses for implanting prosthetic heart valves, and methods of constructing inflatable medical balloons with improved mechanical properties. 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 a 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] Inflatable balloons can be used for a variety of medical purposes within a body, for example, the deployment of a prosthetic valve, using a fluid from a fluid source flowing intoan inner, annular space within the balloon to inflate the balloon from the inside. If the balloon is overinflated, the balloon can burst during expansion. Depending on stresses within the balloon wall, the wall configuration, and the wall material properties, the shape of the balloon can also distort as it grows, thereby affecting its ability to expand and deploy a surrounding prosthetic valve in a known and consistent manner. If the balloon expands more axially than radially, a prosthetic valve mounted on the balloon may not fully deploy or deploy in a desired location. It is therefore desirable to improve the strength of the balloon to withstand higher pressures, while also better controlling the shape during inflation for improved reliability. SUMMARY

[0005] Described herein are prosthetic heart valves, delivery apparatuses, and balloons for expanding and implanting prosthetic heart valves or other medical devices within a body. Also disclosed herein are methods of forming expandable balloons wherein the balloon walls, including the material properties and layers, are optimized for both assembly and performance during inflation.

[0006] A medical device for insertion within a portion of a patient’s body can comprise an inflatable balloon. In addition to these components, the medical device can comprise one or more of the components disclosed herein.

[0007] In some examples, the inflatable balloon can comprise a wall comprising a first layer, a second layer radially outward of the first layer, and a third layer radially outward of the second layer, wherein the first layer and the third layer are not thermally bondable to the second layer.

[0008] In some examples, the inflatable balloon can comprise a first end cap and a second end cap.

[0009] In some examples, the first end cap can be bonded to the first layer and the third layer at a first end of the wall, and the second end cap can be bonded to the first layer and the third layer at a second end of the wall.

[0010] In some examples, the first layer, the third layer, and the first and second end caps can comprise a first material, and the second layer can comprise a second material that is different from the first material.

[0011] In some examples, the second material can be less compliant than the first material.

[0012] In some examples, the second material can have a higher stiffness modulus than the first material.

[0013] In some examples, the first material can comprise a polyamide or co-polyamide.

[0014] In some examples, the second material can comprise a polyethylene terephthalate, polybutylene terephthalate, thermoplastic elastomer copolyester, or combinations thereof.

[0015] In some examples, the first material can comprise nylon.

[0016] In some examples, the first layer, the third layer, the first end cap, and the second end cap can be made of materials that are thermally bondable to each other.

[0017] In some examples, the first end cap and a first end portion of the first layer can be bonded to a first surface of the medical device and the second end cap and a second end portion of the first layer can be bonded to a second surface of the medical device.

[0018] In some examples, the medical device can comprise a first shaft and a nose cone, wherein the first surface can be an outer surface of the first shaft and the second surface can be an outer surface of the nose cone.

[0019] In some examples, the medical device can comprise a second shaft extending coaxially through the first shaft, wherein the nose cone is positioned on a distal end portion of the second shaft at a location distally spaced from a distal end of the first shaft.

[0020] In some examples, the first end cap and the second end cap can be cylindrical.

[0021] In some examples, the first layer, the third layer, the first end cap, and the second end cap can seal and encapsulate the second layer.

[0022] In some examples, a medical device comprises one or more of the components recited in Examples 1-24 below.

[0023] In some examples, a medical device for insertion within a portion of a patient’s body comprises an inflatable balloon having a wall comprising a first layer, a second layer radiallyoutward of the first layer, and a third layer radially outward of the second layer, wherein the first layer and the third layer are not thermally bondable to the second layer, wherein the balloon further comprises a first end cap and a second end cap, the first end cap being bonded to the first layer and the third layer at a first end of the wall, and the second end cap being bonded to the first layer and the third layer at a second end of the wall.

[0024] In some examples, a medical device for insertion within a portion of a patient’s body comprises an inflatable balloon having a wall comprising a first layer, a second layer radially outward of the first layer, and a third layer radially outward of the second layer, wherein the first layer and the third layer are not thermally bondable to the second layer, and wherein a first end portion of the first layer is fixed to a first end portion of the third layer and a second end portion of the first layer is fixed to a second end portion of the third layer.

[0025] In some examples, a medical device for insertion within a body vasculature comprises an inflatable balloon having a wall comprising a first layer, a second layer radially outward of the first layer, and a third layer radially outward of the second layer, wherein the balloon further comprises a first end cap and a second end cap, wherein the first end cap is in axial abutment with a first end of the wall and the second end cap is in axial abutment with a second end of the wall. The medical device further comprises a shaft and a nose cone, wherein a first end portion of the first layer and the first end cap are bonded to an outer surface of the shaft and a second end portion of the first layer and the second end cap are bonded to an outer surface of the nose cone.

[0026] A method of making a medical device, the method comprising forming an inflatable balloon having a wall comprising a first layer, a second layer radially outward of the first layer, and a third layer radially outward of the second layer, wherein the first layer and third layer are not thermally bondable to the second layer. In addition to these steps, the method of making a medical device can further comprise one or more of the steps disclosed herein.

[0027] In some examples, the method can further comprise placing a first end cap in axial abutment with a first end of the wall, wherein the first end cap contacts a first end of the first layer and a first end of the third layer.

[0028] In some examples, the method can further comprise placing a second end cap in axial abutment with a second end of the wall, wherein the second end cap contacts a second end of the first layer and a second end of the third layer.

[0029] In some examples, the method can further comprise bonding the first end cap to the first and third layers at the first end of the wall.

[0030] In some examples, the method can further comprise bonding the second end cap to the first and third layers at the second end of the wall.

[0031] In some examples, the method can further comprise a first end of the second layer axially aligned with the first end of the first layer and the first end of the third layer and a second end of the second layer axially aligned with the second end of the first layer and the second end of the third layer.

[0032] In some examples, the method can further comprise bonding the first end cap and a first end portion of the first layer to a first surface of the medical device and bonding the second end cap and a second end portion of the first layer to a second surface of the medical device.

[0033] In some examples, the method can further comprise sealing the first layer and the third layer to both the first end cap and the second end cap, thereby encapsulating the second layer.

[0034] In some examples, the method can further comprise applying heat and pressure to the first end of the wall, the first end cap, the second end of the wall, and the second end cap.

[0035] In some examples, the method can further comprise placing heat shrink tubing around a first end portion of the wall, the first end cap, a second end portion of the wall, and the second end cap, and heating the heat shrink tubing.

[0036] In some examples, a method of making a medical device comprising one or more of the acts or components recited in Examples 25-31 below.

[0037] 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 tolimit 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

[0038] FIG.1 is a side view of a prosthetic heart valve, according to one example.

[0039] FIG.2A is a side view of a delivery apparatus for a prosthetic heart valve, according to one example.

[0040] FIG.2B is an enlarged view of the distal portion of the delivery apparatus of FIG. 2A.

[0041] FIG.3 is a cross-sectional view of an expandable balloon mounted on a distal portion of a delivery apparatus before bonding the end portions of the balloon, according to one example.

[0042] FIG.4 is a partial, side view of an exterior surface of the expandable balloon of FIG. 3.

[0043] FIG.5 is a partial, perspective view of an exterior surface of the expandable balloon of FIG.3.

[0044] FIG.6 is a cross-sectional view of the expandable balloon of FIG.3 illustrating a method for bonding the end portions of the balloon, according to one example.

[0045] FIG.7 is a cross-sectional view of the expandable balloon of FIG.3 after bonding the end portions of the balloon.

[0046] FIG.8 is a cross-sectional view of an expandable balloon mounted on a distal portion of a delivery apparatus before bonding the end portions of the balloon, according to another example. DETAILED DESCRIPTION General Considerations

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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 deviceaway 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.

[0051] As used herein, “for example” means “for example,” and “e.g.” means “that is.” Examples of the Disclosed Technology

[0052] Described herein are examples of a medical device, such as a delivery apparatus (sometimes referred to as a delivery catheter) 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 such medical devices 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; positioning energy sources, for example, for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, and the like; performing a valvuloplasty, angioplasty, or other remodeling procedures; and delivering agents, such as drugs, into a patient’s body.

[0053] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed configuration during delivery, and then expanded to the radially expanded configuration 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. In some examples, the prosthetic valve can be deployed from the delivery apparatus at the implantation site (e.g., a native valve of a heart) via inflating an inflatable balloon of the delivery apparatus. When radially compressed onto the inflatable balloon of the delivery apparatus, inner surfaces of the frame of the prosthetic valve can face the balloon.

[0054] FIG.1 shows a prosthetic heart valve 10 (which is also referred to herein as a “prosthetic valve”), 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.

[0055] 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. WO2020 / 247907, which is incorporated by reference herein. 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 by reference herein.

[0056] The prosthetic valve 10 can include a stent or frame 12, a valvular structure 14, an inner skirt 16, and a perivalvular outer sealing member or outer skirt 18. The prosthetic valve 10 can have an inflow end portion 15, an intermediate portion 17, and an outflow end portion 19. The inner skirt 16 can be arranged on and / or coupled to an inner surface of the frame 12 while the outer skirt 18 can be arranged on and / or coupled to an outer surface of the frame 12.

[0057] The valvular structure 14 can comprise three leaflets 40, collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, although in otherexamples there can be a greater or fewer number of leaflets (for example, one or more leaflets 40). The leaflets 40 can be secured to one another at their adjacent sides to form commissures 22 of the valvular structure 14. The lower edge of valvular structure 14 can have an undulating, curved, scalloped shape and can be secured to the inner skirt 16 by sutures (not shown). In some examples, the leaflets 40 can be formed of pericardial tissue (for example, bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated by reference herein.

[0058] The frame 12 can be radially compressible (collapsible) and expandable (for example, expanded configuration shown in FIG.1) and comprise a plurality of interconnected struts 24. A plurality of apices 26 that are spaced circumferentially apart are formed at the inflow end portion 15 and the outflow end portion 19 of the frame 12 (only the apices 26 at the outflow end portion 19 are visible in FIG.1). Each apex 26 is formed at a junction between two angled struts 24 at either the inflow end portion 15 or the outflow end portion 19. FIG.1 depicts a known frame design with apices 26 that form a U-shaped bend between the two angled struts 24. In some examples, an angle 30 between the two angled struts 24, connected at the apex 26, can be in a range of 90 to 120 degrees.

[0059] The frame 12 can be formed with a plurality of circumferentially spaced slots, or commissure windows 20 that are adapted to mount the commissures 22 of the valvular structure 14 to the frame. The frame 12 can be made of any of various suitable plastically- expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol). When constructed of a plastically-expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially collapsed configuration on a delivery catheter or apparatus and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic valve can be advanced from the sheath, which allows the prosthetic valve to expand to its functional size.

[0060] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, frame 12, etc.) include, metal alloys, polymers, orcombinations 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 12 can comprise stainless steel. In some examples, the frame 12 can comprise cobalt-chromium. In some examples, the frame 12 can comprise nickel-cobalt- chromium. In some examples, the frame 12 comprises a nickel-cobalt-chromium- molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-2). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0061] Any one of the skirts 16 and 18 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 16 and / or 18 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 16 and / or 18 can comprise a fabric without interlaced yarns or fibers or randomly 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 16 and / or 18 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 16 and / or 18 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the skirts 16 and / or 18 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0062] Additional details regarding the prosthetic valve 10 and its various components are described in WIPO Patent Application Publication No. WO 2018 / 222799, which is incorporated by reference herein.

[0063] FIG.2A shows a delivery apparatus 100, according to an example, which can be used to implant an expandable prosthetic valve (for example, prosthetic valve 10 of FIG.1 or anyof the other prosthetic valves described herein). In some examples, the delivery apparatus 100 is specifically adapted for use in introducing a prosthetic valve into a heart.

[0064] The delivery apparatus 100 in the illustrated example of FIG.2A is a balloon catheter comprising a handle 102 and a steerable, outer shaft 104 extending distally from the handle 102. The delivery apparatus 100 can further comprise an intermediate shaft 106 (which also may be referred to as a balloon shaft) that extends proximally from the handle 102 and distally from the handle 102, the portion extending distally from the handle 102 also extending coaxially through the outer shaft 104. Additionally, the delivery apparatus 100 can further comprise an inner shaft 108 extending distally from the handle 102 coaxially through the intermediate shaft 106 and the outer shaft 104 and proximally from the handle 102 coaxially through the intermediate shaft 106.

[0065] The outer shaft 104 and the intermediate shaft 106 can be configured to translate (for example, move) longitudinally, along a central longitudinal axis 120 of the delivery apparatus 100, relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a patient’s body.

[0066] The intermediate shaft 106 can include a proximal end portion 110 that extends proximally from a proximal end of the handle 102, to an adaptor 112. A rotatable knob 114 can be mounted on the proximal end portion 110 and can be configured to rotate the intermediate shaft 106 around the central longitudinal axis 120 and relative to the outer shaft 104.

[0067] The adaptor 112 can include a first port 138 configured to receive a guidewire therethrough and a second port 140 configured to receive fluid (for example, inflation fluid) from a fluid source. The second port 140 can be fluidly coupled to an inner lumen of the intermediate shaft 106.

[0068] The intermediate shaft 106 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 104 when a distal end of the outer shaft 104 is positioned away from an inflatable balloon 118 of the delivery apparatus 100. A distal end portion of the inner shaft 108 can extend distally beyond the distal end portion of the intermediate shaft 106.

[0069] The balloon 118 can extend over the inner shaft 108. The balloon 118 can include a distal end portion 118a, an intermediate portion 118b, and a proximal end portion 118c.

[0070] In some examples, the distal end portion 118a of the balloon 118 can be coupled to a distal end of the delivery apparatus 100, such as to a nose cone 122 (as shown in FIG.2A), or to an alternate component at the distal end of the delivery apparatus 100 (for example, a distal shoulder). The proximal end portion 118c of the balloon 118 can be coupled to a distal end portion of the intermediate shaft 106. The intermediate portion 118b of the balloon 118 and the inner shaft 108 can form or define a valve mounting portion 124 of a distal end portion of the delivery apparatus 100. The distal end portion 118a of the balloon 118 can overlay a distal shoulder 126 of the delivery apparatus 100. The valve mounting portion 124 and the intermediate portion of the balloon 118 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG.2A, a prosthetic valve (for example, prosthetic valve 150) can be mounted around the balloon 118 at the valve mounting portion 124 of the delivery apparatus 100. The intermediate portion 118b of the balloon can be referred to herein as a valve mounting portion of the balloon 118.

[0071] The balloon shoulder assembly, including the distal shoulder 126, is configured to maintain the prosthetic heart valve 150 (or other medical device) at a fixed position on the balloon 118 during delivery through the patient’s vasculature.

[0072] The outer shaft 104 can include a distal tip portion 128 mounted on its distal end. The outer shaft 104 and the intermediate shaft 106 can be translated axially relative to one another to position the distal tip portion 128 adjacent a proximal side of the valve mounting portion 124, when the prosthetic valve 150 is mounted in the radially compressed state on the valve mounting portion 124 (as shown in FIG.2A) and during delivery of the prosthetic valve 150 to the target implantation site. As such, the distal tip portion 128 can be configured to resist movement of the prosthetic valve 150 relative to the balloon 118 proximally, in the axial direction, when the distal tip portion 128 is arranged adjacent a proximal side of the valve mounting portion 124.

[0073] An annular space can be defined between an outer surface of the inner shaft 108 and an inner surface of the intermediate shaft 106 and can be configured to receive fluid from a fluid source via the second port 140 of the adaptor 112. The annular space can be fluidlycoupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 108 and an inner surface of the balloon 118. As such, fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the balloon 118 (for example, from a first, deflated state to a second, radially expanded, inflated state) and radially expand and deploy the prosthetic valve 150.

[0074] An inner lumen of the intermediate shaft 106 can be configured to receive a guidewire therethrough, for navigating the distal end portion of the delivery apparatus 100 to the target implantation site.

[0075] The handle 102 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 100. In the illustrated example, for example, the handle 102 includes an adjustment member, such as the illustrated rotatable knob 160, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 102 through the outer shaft 104 and has a distal end portion affixed to the outer shaft 104 at or near the distal end of the outer shaft 104. Rotating the knob 160 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 100. Further details on steering or flex mechanisms for the delivery apparatus 100 can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein.

[0076] The handle 102 can further include an adjustment mechanism 161 including an adjustment member, such as the illustrated rotatable knob 162, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 178. The adjustment mechanism 161 is configured to adjust the axial position of the intermediate shaft 106 relative to the outer shaft 104 (for example, for fine positioning at the implantation site). Further details on the delivery apparatus 100 can be found in WIPO Publication No. WO2022 / 046585, which are incorporated by reference herein.

[0077] FIG.2A shows an example of the delivery apparatus 100 being used for “on-balloon” delivery. For such on-balloon delivery, the prosthetic valve 150 is radially compressed (or “crimped”) directly onto the valve mounting portion 124 of the delivery apparatus 100, for example, around the intermediate portion 118b of the balloon 118 prior to insertion of the prosthetic valve 150 and the delivery apparatus 100 into a patient’s vasculature. In anotherexample, the delivery apparatus 100 can be used “off-balloon” delivery, which involves initially mounting the radially compressed prosthetic valve at a location on the delivery apparatus offset from the valve mounting portion 124, such as at a location on the shaft 106 proximal to the balloon. After the delivery apparatus 100 is inserted into a patient’s vasculature, the prosthetic valve can be moved onto the valve mounting portion 124, such as by pushing the prosthetic valve distally with the outer shaft 104. Further details of using a delivery apparatus for off-balloon delivery are disclosed in U.S. Patent No.9,339,384.

[0078] FIG.2B is a close-up view of the distal end portion of the delivery apparatus 100 of FIG.2A, specifically showing the valve mounting portion 124 located at a distal end of the shaft 106. The prosthetic valve 150 is excluded from FIG.2B to better illustrate the intermediate portion 118b of the balloon 118. The balloon 118 in FIG.2B is shown in a collapsed (uninflated) configuration surrounding the inner shaft 108, wherein an outer diameter of the intermediate portion 118b is reduced compared to an outer diameter of the distal end portion 118a and an outer diameter of the proximal end portion 118c, this reduced diameter accommodating the surrounding, collapsed prosthetic valve 150 (not shown in FIG. 2B).

[0079] FIG.3 is a cross-sectional view of a medical device or medical apparatus 300 comprising an expandable balloon 302a, according to one example. The balloon 302a (and all other balloons disclosed herein) can be incorporated into any medical apparatus, such as delivery apparatuses for implanting an implantable medical device (such as prosthetic valves and stents) and / or apparatuses for performing any of various medical procedures inside a patient’s body, such as a valvuloplasty or angioplasty.

[0080] In the illustrated example, the medical apparatus 300 comprises a first shaft 306, a second shaft 308 extending coaxially through the first shaft, and a nose cone 310 mounted on the distal end portion of the second shaft 308. In some examples, the medical apparatus 300 comprises the delivery apparatus 100 and can include some or all of the components described and shown in FIGS.2A and 2B. In such examples, the first shaft 306 corresponds to the shaft 106, the second shaft 308 corresponds to the shaft 108, and the nose cone 310 corresponds to the nose cone 122. As shown, a distal end portion 312 of the balloon 302a can be coupled to the nose cone 310 and a proximal end portion 314 of the balloon 302a can be coupled to a distal end portion of the shaft 306. The distal end portion 312 of the balloon302a can be alternatively coupled to another component (for example, a distal shoulder 316) along a distal end of the medical apparatus 300.

[0081] In some examples, the balloon 302a is bonded to both the nose cone 310 and the shaft 306 in a manner that will be discussed later herein.

[0082] As previously described in reference to the balloon 118, the balloon 302a can likewise be radially expanded using an inflation fluid or other mechanical means. When the balloon 302a expands, the balloon grows radially, pushing an inner surface of a surrounding prosthetic valve (for example, prosthetic valve 10 or 150), thereby expanding the prosthetic valve radially so it contacts and deploys within a native annulus. During inflation, it is desirable for the balloon to withstand higher pressures to prevent unintentional rupture, at all locations throughout the balloon wall but particularly at the ends. It is also desirable for the balloon to expand to an expected and improved shape for better valve positioning and deployment at an implantation site.

[0083] The compliance of a balloon refers to the ability of the balloon to expand from a predetermined increase in inflation pressure. Compliant and semi-compliant balloons typically respond to an increase in inflation pressure by initially increasing in diameter along sections of the balloon subject to less resistance. Also, compliant and semi-compliant balloons typically can stretch radially and / or axially under inflation pressure and are prone to tear in the circumferential or radial direction if the balloon bursts from being overinflated, which can make retrieval of the burst balloon difficult. Non-compliant balloons typically exhibit less stretchability in the radial and / or axial direction. In some examples, balloons disclosed herein can stretch more in the radial direction and / or less in the axial direction than compliant or semi-compliant balloons under inflation pressure. Also, in some examples, balloons disclosed herein are less prone to tearing in the circumferential direction if the balloon bursts from being overinflated.

[0084] To achieve a higher burst pressure and / or an improved shape, the material properties of a balloon wall can be optimized. If the wall of the balloon comprises a less compliant, stiffer layer, it is more likely to resist axial growth during expansion and transfer higher forces in a radial direction, thereby resulting in a superior and more predictable balloon shape when inflated. Furthermore, using a less compliant material can increase the burst pressureof the balloon, preventing early rupture. Advantageously, in the event of failure, a wall made of material that is stronger and easily orientable in the axial direction can burst in an axial direction with a tear extending longitudinally between a proximal end and a distal end rather than in a circumferential direction, leading to easier retrieval thereafter. For example, a parison made from polyethylene terephthalate (PET) can be blow molded under heat and pressure at a temperature below the glass transition temperature of PET to form a balloon. During the blow molding process, the PET is in a rubbery state, allowing the polymer to orient axially (along the length of the balloon). As such, a balloon wall made of PET is more likely to tear axially than circumferentially if the balloon ruptures.

[0085] Some less or non-compliant balloon materials, such as PET, however, are thermally incompatible with other commonly used components of the medical apparatus, such as polyamides and co-polyamides, which makes mounting of a non-compliant balloon on the medical apparatus difficult and / or impractical. Although adhesives can be used for attaching a non-compliant balloon to a medical apparatus, adhesives often do not form a strong enough bond for the intended use of the medical apparatus. Thus, it is desirable to construct a balloon from less compliant materials to improve balloon performance in combination with more traditional compliant materials to ensure that the balloon is securely bonded to the medical apparatus.

[0086] The balloon 302a of FIG.3 comprises a wall 318 comprising a plurality of layers, including a first layer 320 (which also may be referred to as an inner layer), a second layer 322 (which also may be referred to as an intermediate or middle layer), and a third layer 324 (which also may be referred to as an outer layer). At a first, proximal end 326 of the balloon wall 318, an end portion 328 of the inner layer is aligned with an end portion 330 of the intermediate layer, and an end portion 332 of the outer layer. The proximal end portions 328, 330, 332 of the individual layers collectively define a proximal end portion 327 of the balloon wall 318. As shown in FIG.3, at a second, distal end 334 of the wall 318, an end portion 336 of the inner layer is similarly aligned with an end portion 338 of the intermediate layer and an end portion 340 of the outer layer. The distal end portions 336, 338, 340 of the individual layers collectively define a distal end portion 335 of the balloon wall.

[0087] In one example, the inner and outer layers 320, 324 can be made of a first material comprising, for example, a polyamide (PA) or co-polyamide, such as nylon (for examplenylon 12), Pebax®, or Grilamid L25. The inner and outer layers 320, 324 can be made of the same first material or different, yet thermally bondable materials. The intermediate layer 322 can be made of a second material that is less compliant than the first material. This second material can have a higher stiffness modulus than the first material and can comprise, for example, a polyester, such as polyethylene terephthalate (PET), polybutylene terephthalate, a thermoplastic elastomer copolyester (such as Hytrel®), or combinations thereof. It is known in the art that PA and PET are thermally non-bondable to each other, therefore if made from such materials, the intermediate layer 322 cannot be thermally bonded to either the inner or outer layers 320, 324. Nonetheless adding a less compliant intermediate layer can result in a higher burst pressure and optimized shape during deployment with lower compliance in the axial direction. Moreover, due to the presence of the intermediate layer 322, the balloon is more likely to tear axially than circumferentially if the balloon ruptures, which facilitates removal of the balloon from the patient.

[0088] The inner and outer layers 320, 324 in FIG.3 are made of materials, whether the same material or different materials, that can be thermally bonded to each other and other components of the delivery apparatus, such as, the first shaft 306 and the nose cone 310. However, in this example, the inner and outer layers 320, 324 do not contact each other at the proximal and distal ends 326, 334, respectively, of the balloon wall 318. Additionally, as previously discussed, if the first and second materials are thermally incompatible, the inner and outer layers 320, 324 cannot be thermally bonded to the intermediate layer 322.

[0089] To seal the layers 320, 322, and 324 to each other, a first, proximal end cap 342 and a second end cap 344 can be bonded to the proximal and distal ends of the balloon wall 318, in particular, the adjacent surfaces of the first layer 320 and the third layer 324 at the proximal end 326 and the distal end 334. As shown in FIGS.3-5, an interior side surface 346 of the first end cap 342 is assembled into axial abutment with the proximal end portions 328, 330, and 332 of the layers 320, 322, and 324, respectively, while an interior side surface 348 of the second end cap 344 is assembled into axial abutment with the distal end portions 336, 338, and 340 of the layers 320, 322, and 324.

[0090] In the example of FIGS.3-5, the first and second end caps 342, 344 are truncated cylinders in the shape of a flattened ring or donut, but the end caps can take any shape so longas they contact the adjacent surfaces of the layers 320, 324 and adjacent surfaces of the medical apparatus for complete bonding, sealing, and fusing to occur.

[0091] The end cap 342 is shown coaxial with and extending over the first shaft 306 while the end cap 344 is shown coaxial with and extending over the nose cone 310. An inner diameter of the end cap 342 is large enough to slide into position over an outer diameter of the first shaft 306 while ensuring adequate contact with the outer surface of the first shaft 306 for thermal bonding to occur therebetween. An inner diameter of the end cap 344 is similarly sized with respect to the nose cone 310. The end caps 342 and 344 are made of materials that are thermally bondable with the first shaft 306, the nose cone 310, and the inner and outer layers 320, 324, including but not limited to a polyamide or co-polyamide, such as nylon, (for example nylon 12), Pebax®, or Grilamid L25. Thus, in some examples, the end caps 342, 344 can be made of the same first material as the inner layer 320 and the outer layer 324 of the balloon wall 318. In some examples, the end caps 342, 344 can be made from different materials so long as they can be thermally bonded to the materials of the inner layer 320 and outer layer 324, as well as the shaft 306 and nose cone 310. In some examples, the end caps 342, 344 can be made of the same material, wherein the material forming the end caps is different from the material(s) forming the inner layer 320 and outer layer 324, so long as the end caps can be thermally bonded to the inner layer 320, the outer layer 324, the shaft 306, and the nose cone 310.

[0092] A radial inner surface 350 of the end cap 342 and a proximal inner surface 352 of the inner layer 320 are further thermally bondable to an outer surface 354 of the first shaft 306 while a radial inner surface 356 of the end cap 344 and a distal inner surface 358 of the inner layer 320 are further thermally bondable to an outer surface 360 of the nose cone 310.

[0093] FIGS.3-5 show the balloon 302a assembled on the medical apparatus prior to a thermal bonding procedure. FIG.6 shows the assembled balloon 302a with the addition of a first heat shrink tube element 370 applied over the proximal end portion 327 of the balloon wall 318 and the proximal end cap 342 and a second heat shrink tube element 372 applied over the distal end portion 335 of the balloon wall 318 and the distal end cap 344. Heat is thereafter applied to the heat shrink tube elements 370, 372, thereby causing the tube elements to shrink circumferentially around the proximal and distal end portions 327, 335, respectively, and the proximal and distal end caps 342, 344, respectively. During heatshrinking, a radial compressive force is applied to the layers of the balloon and the end caps, holding the assembly in place and maintaining contact between bondable surface areas for the duration of the bonding operation.

[0094] If the tube element 370 comprises a segment e1 extending axially beyond an outer surface 380 of the first end cap 342 and / or tube element 372 comprises a segment e2 extending axially beyond an outer surface 382 of the second end cap 344, the tube elements can further shrink in diameter in those extended segments e1 and e2, thereby closing around the outside of the end caps 342 and 344 and further providing an axial compressive force against outer surfaces 380 and 382 during the heat shrink operation.

[0095] The pressure combined with the heat causes the bondable components of the layered balloon and the end caps to seal and fuse together, forming a unitary structure. Additionally, under heat and pressure, the radial inner surface 350 of end cap 342 and the proximal inner surface 352 of the inner layer 320 thermally bond to the outer surface 354 of the first shaft 306 while the radial inner surface 356 of end cap 344 and the distal inner surface 358 of the inner layer 320 thermally bond to the outer surface 360 of the nose cone 310.

[0096] The heat shrink tube elements 370 and 372 in the example of FIG.6 are cylindrical sleeves extending over the proximal and distal end portions 327, 335, but any heat shrink elements known in the art including, heat shrink tape, can be used. In some examples, in lieu of or in addition to using the heat shrink tube elements, laser bonding can be used to thermally bond the end caps 342, 344 to the layers 320, 324, the shaft 306 and / or the nose cone 310. In addition, the bonding operation herein is disclosed as a thermal bonding operation, but other bonding operations can be used so long as the components made of bondable materials seal to form a continuous structure.

[0097] Once the bonding operation is complete, the heat shrink tube elements 370 and 372 can be removed from the proximal and distal end portions 327, 335, leaving an integrated balloon 302b of FIG.7 intact in a fused configuration. FIG.7 shows the structure of the end caps and the layers of the balloon wall after the bonding operation, wherein the inner layer 320, the outer layer 324 and the end caps 342 and 344 fuse to form a continuous sealing envelope 390 encapsulating the intermediate layer 322. In addition, after bonding, the proximal end portion 328 of the inner layer 320 is fixed to the proximal end portion 332 ofthe outer layer 324 via the end cap 342, and the distal end portion 336 of the inner layer 320 is fixed to the distal end portion 340 of the outer layer 324 via the end cap 344. A proximal inner surface 392 and a distal inner surface 394 of the integrated balloon 302b are also bonded to the outer surface 354 of the first shaft 306 and the outer surface 360 of the nose cone 310, respectively. As a result of the integrated structure of balloon 302b of FIG.7, the proximal and distal end portions 327 and 335 are strengthened. Due to the stiffer intermediate layer 322, when the balloon 302b is expanded, it is more likely to resist axial growth and transfer higher forces in a radial direction, thereby withstanding a higher pressure and retaining an advantageous shape.

[0098] FIG.8 is a cross-sectional view of a medical apparatus 400 comprising an expandable balloon 402, according to another example. The balloon 402 (like all other balloons disclosed herein) can be incorporated into any medical apparatus, such as delivery apparatuses for implanting an implantable medical device (such as, prosthetic valves and stents) and / or apparatuses for performing any of various medical procedures inside a patient’s body, such as a valvuloplasty or angioplasty.

[0099] Like the example shown in FIGS.3-7, the medical apparatus 400 comprises a first shaft 306, a second shaft 308 extending coaxially through the first shaft, and a nose cone 310 mounted on the distal end portion of the second shaft 308. In some examples, the medical apparatus 400 comprises the delivery apparatus 100 and can include some or all of the components described and shown in FIGS.2A and 2B. In such examples, the first shaft 306 corresponds to the shaft 106, the second shaft 308 corresponds to the shaft 108, and the nose cone 310 corresponds to the nose cone 122.

[0100] As shown in FIG.8, a distal end portion 404 of the balloon 402 can be coupled to the nose cone 310 and a proximal end portion 406 of the balloon 402 can be coupled to a distal end portion of the shaft 306. The distal end portion 404 of the balloon 402 can be alternatively coupled to another component (for example, a distal shoulder 316) along a distal end of the medical apparatus 400.

[0101] As previously described in reference to balloons 118 and 302a, the balloon 402 can likewise be radially expanded using an inflation fluid or other mechanical means. As described with respect to balloon 302a, when the balloon 402 expands, it grows radially,pushing an inner surface of a surrounding prosthetic valve (for example, prosthetic valve 10 or 150), thereby expanding the prosthetic valve radially so it contacts and deploys within a native annulus.

[0102] As previously described, to achieve a higher burst pressure and / or an improved shape, the material properties of the balloon 402 can be optimized. The balloon 402 of FIG.8 comprises a wall 408 with a plurality of layers, including a first layer 410 (which also may be referred to as an inner layer), a second layer 412 (which also may be referred to as an intermediate or middle layer), and a third layer 414 (which also may be referred to as an outer layer). At a first, proximal end 416 of the balloon wall 408, an end portion 420 of the inner layer 410 is aligned with an end portion 422 of the outer layer 414. The proximal end portions 420 and 422 of the inner and outer layers collectively define a proximal end portion 427 of the balloon wall 408. As shown in FIG.8, at a second, distal end 418 of the wall 408, an end portion 426 of the inner layer 410 is similarly aligned with an end portion 428 of the outer layer 414. The distal end portions 426, 428 of the individual layers collectively define a distal end portion 435 of the balloon wall.

[0103] In the example of FIG.8, similar to the balloon 302a in FIG.3, the inner and outer layers 410, 414 of balloon 402 can be made of a first material comprising, for example, a polyamide (PA) or co-polyamide, such as nylon (for example nylon 12), Pebax®, or Grilamid L25. The inner and outer layers 410, 414 can be made of the same first material or different, yet thermally bondable materials. The intermediate layer 412 can be made of a second material that is less compliant than the first material. This second material can have a higher stiffness modulus than the first material and can comprise, for example, a polyester, such as polyethylene terephthalate (PET), polybutylene terephthalate, a thermoplastic elastomer copolyester (such as Hytrel®), or combinations thereof. PA and PET are thermally non- bondable to each other and, if made from such materials, the intermediate layer 412 cannot be thermally bonded to either the inner or outer layers 410, 414.

[0104] The inner and outer layers 410, 414 in FIG.8 are made of materials, whether the same material or different materials, that can be thermally bonded to each other and other components of the delivery apparatus, such as, the first shaft 306 and the nose cone 310.

[0105] In contrast to balloon 302a of FIGS.3-6, in balloon 402 of FIG.8, a proximal end portion 436 of the intermediate layer 412 of the balloon wall 408 does not align with the proximal end portions 420, 422 of the inner and outer layers, nor does a distal end portion 438 of the intermediate layer align with the distal end portions 426, 428 of the inner and outer layers. Instead, as shown in FIG.8, the inner and outer layers 410, 414 contact each other directly at the proximal and distal end portions 427 and 435 of the balloon wall 408 at a proximal interface 440 and a distal interface 442. The inner and outer layers 410, 414 can therefore be bonded and fused directly to each other at the interfaces 440 and 442, thereby achieving a higher burst pressure and a better shape during deployment due to intermediate layer 412, without the need for end caps.

[0106] FIG.8 shows the balloon 402 assembled prior to a thermal bonding procedure, wherein a proximal inner surface 444 of the inner layer 410 contacts the surface 354 and a distal inner surface 446 of inner layer 410 contacts the surface 360 of the nose cone. Just as the heat shrink tube elements 370 and 372 in the example of FIG.6 extend over the proximal and distal end portions 327 and 335 of balloon 302a, heat shrink tube elements (not shown in FIG.8) can be applied over the proximal and distal end portions 427 and 435 of balloon 402. Heat shrink tube elements can be sized to surround the interfaces 440 and 442 of the proximal and distal end portions 427 and 435 and can optionally include extension elements, ensuring sufficient radial and / or axial pressure during bonding. Other heat shrink configurations can be similarly used, including but not limited to heat shrink tape, so long as the heat shrink configuration covers the areas intended for bonding. In addition, the bonding operation herein is disclosed as a thermal bonding operation, but other bonding operations can be used with this example so long as the components made of bondable materials seal to form a continuous structure.

[0107] The description of the bonding process as set forth for the apparatus in FIG.6 can also apply to the apparatus of FIG.8. Under heat and pressure, the interfacing surfaces of inner layer 410 and outer layer 414 at the proximal interface 440 and the distal interface 442 can be similarly bonded and fused, forming a unitary structure. Furthermore, under heat and pressure the proximal inner surface 444 of the inner layer 410 bonds to the outer surface 354 of the first shaft 306 while the distal inner surface 446 of the inner layer 410 bonds to the outer surface 360 of the nose cone 310.

[0108] Once the bonding operation is complete, any heat shrink elements can be removed from the proximal and distal end portions 427, 435, leaving a fused balloon assembly. In this fused assembly, the inner layer 410 and the outer layer 414 combine to form a continuous sealing envelope encapsulating the intermediate layer 412 within. The proximal inner surface 444 and the distal inner surface 446 of the inner layer 410 are bonded to the outer surface 354 of the first shaft 306 and the outer surface 360 of the nose cone 310, respectively. This fused balloon can resist axial growth and transfer higher forces in a radial direction during expansion, thereby withstanding a higher pressure and retaining an advantageous shape without the need for additional end caps.

[0109] Although the examples presented herein detail medical balloons for use in expanding a prosthetic valve (for example, prosthetic valve 10 or 150) at an implantation site, the balloons (any example of fused balloon detailed herein) can also be used anywhere within the body for any variety of medical procedures, including but not limited to valvuloplasty or angioplasty, among others. Sterilization

[0110] 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

[0111] 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 prostheticvalve is positioned within the native aortic valve and radially expanded (e.g., 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.

[0112] 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.

[0113] 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.

[0114] 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.

[0115] 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

[0116] 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.

[0117] Example 1. A medical device for insertion within a portion of a patient’s body, the device comprising: an inflatable balloon having a wall comprising a first layer, a second layer radially outward of the first layer, and a third layer radially outward of the second layer, wherein the first layer and the third layer are not thermally bondable to the second layer, wherein the balloon further comprises a first end cap and a second end cap, the first end cap being bonded to the first layer and the third layer at a first end of the wall, and the second end cap being bonded to the first layer and the third layer at a second end of the wall.

[0118] Example 2. The medical device of any example herein, particularly example 1, wherein the first layer, the third layer, and the first and second end caps comprise a first material, and the second layer comprises a second material that is different from the first material.

[0119] Example 3. The medical device of any example herein, particularly example 2, wherein the second material is less compliant than the first material.

[0120] Example 4. The medical device of any example herein, particularly any one of examples 2-3, wherein the second material has a higher stiffness modulus than the first material.

[0121] Example 5. The medical device of any example herein, particularly any of examples 2-4, wherein the first material comprises a polyamide or co-polyamide.

[0122] Example 6. The medical device of any example herein, particularly any of examples 2-5, wherein the second material comprises a polyethylene terephthalate, polybutylene terephthalate, thermoplastic elastomer copolyester, or combinations thereof.

[0123] Example 7. The medical device of any example herein, particularly any of examples 2-6, wherein the first material comprises nylon.

[0124] Example 8. The medical device of any example herein, particularly example 1, wherein the first layer, the third layer, the first end cap, and the second end cap are made of materials that are thermally bondable to each other.

[0125] Example 9. The medical device of any example herein, particularly any preceding example, wherein the first end cap and a first end portion of the first layer are bonded to a first surface of the medical device and the second end cap and a second end portion of the first layer are bonded to a second surface of the medical device.

[0126] Example 10. The medical device of any example herein, particularly example 9, wherein the medical device comprises a first shaft and a nose cone, wherein the first surface is an outer surface of the first shaft and the second surface is an outer surface of the nose cone.

[0127] Example 11. The medical device of any example herein, particularly example 10, wherein the medical device comprises a second shaft extending coaxially through the first shaft, wherein the nose cone is positioned on a distal end portion of the second shaft at a location distally spaced from a distal end of the first shaft.

[0128] Example 12. The medical device of any example herein, particularly any preceding example, wherein the first end cap and the second end cap are cylindrical.

[0129] Example 13. The medical device of any example herein, particularly any preceding example, wherein the first layer, the third layer, the first end cap, and the second end cap seal and encapsulate the second layer.

[0130] Example 14. A medical device for insertion within a portion of a patient’s body, the device comprising: an inflatable balloon having a wall comprising a first layer, a second layer radially outward of the first layer, and a third layer radially outward of the second layer, wherein the first layer and the third layer are not thermally bondable to the second layer, and wherein a first end portion of the first layer is fixed to a first end portion of the third layer and a second end portion of the first layer is fixed to a second end portion of the third layer.

[0131] Example 15. The medical device of any example herein, particularly example 14, wherein the first end portion of the first layer is bonded to a first surface of the medical device and the second end portion of the first layer is bonded to a second surface of the medical device.

[0132] Example 16. The medical device of any example herein, particularly any one of examples 14 and 15, wherein the first layer and the third layer comprise a first material, and the second layer comprises a second material that is different from the first material.

[0133] Example 17. The medical device of any example herein, particularly example 16, wherein the first material comprises a polyamide or co-polyamide.

[0134] Example 18. The medical device of any example herein, particularly any one of examples 16 and 17, wherein the second material comprises a polyethylene terephthalate, polybutylene terephthalate, thermoplastic elastomer copolyester, or combinations thereof.

[0135] Example 19. A medical device for insertion within a body vasculature, the device comprising: an inflatable balloon having a wall comprising a first layer, a second layer radially outward of the first layer, and a third layer radially outward of the second layer, wherein the balloon further comprises a first end cap and a second end cap, wherein the first end cap is in axial abutment with a first end of the wall and the second end cap is in axial abutment with a second end of the wall; a shaft; and a nose cone, wherein a first end portion of the first layer and the first end cap are bonded to an outer surface of the shaft and a second end portion of the first layer and the second end cap are bonded to an outer surface of the nose cone.

[0136] Example 20. The medical device of any example herein, particularly example 19, wherein the first end cap is bonded to the first and third layers at a first end of the wall, and the second end cap is bonded to the first and third layers at a second end of the wall.

[0137] Example 21. The medical device of any example herein, particularly any of examples 19 and 20, wherein the first layer, the third layer, and the first and second end caps comprise a first material, and the second layer comprises a second material that is different from the first material.

[0138] Example 22. The medical device of any example herein, particularly example 21, wherein the first material comprises a polyamide or co-polyamide.

[0139] Example 23. The medical device of any example herein, particularly any of examples 21 and 22, wherein the second material comprises a polyethylene terephthalate, polybutylene terephthalate, thermoplastic elastomer copolyester, or combinations thereof.

[0140] Example 24. The medical device of any example herein, particularly any of examples 19-23, wherein the first layer, the third layer, the first end cap, and the second end cap are made of materials that are thermally bondable to each other.

[0141] Example 25. A method of making a medical device, the method comprising: forming an inflatable balloon having a wall comprising a first layer, a second layer radially outward of the first layer, and a third layer radially outward of the second layer, wherein the first layer and third layer are not thermally bondable to the second layer; placing a first end cap in axial abutment with a first end of the wall, wherein the first end cap contacts a first end of the first layer and a first end of the third layer; placing a second end cap in axial abutment with a second end of the wall, wherein the second end cap contacts a second end of the first layer and a second end of the third layer; bonding the first end cap to the first and third layers at the first end of the wall; and bonding the second end cap to the first and third layers at the second end of the wall.

[0142] Example 26. The method of any example herein, particularly example 25, wherein a first end of the second layer is axially aligned with the first end of the first layer and the first end of the third layer and a second end of the second layer is axially aligned with the second end of the first layer and the second end of the third layer.

[0143] Example 27. The method of any example herein, particularly any of examples 25 and 26, comprising bonding the first end cap and a first end portion of the first layer to a first surface of the medical device and bonding the second end cap and a second end portion of the first layer to a second surface of the medical device.

[0144] Example 28. The method of any example herein, particularly example 27, wherein the medical device comprises a shaft and a nose cone, wherein the first surface is an outer surface of the shaft and the second surface is an outer surface of the nose cone.

[0145] Example 29. The method of any example herein, particularly any of examples 25-28, wherein bonding seals the first layer and the third layer to both the first end cap and the second end cap, thereby encapsulating the second layer.

[0146] Example 30. The method of any example herein, particularly any of examples 25-29, wherein bonding the first end cap to the first and third layers at the first end of the wall and bonding the second end cap to the first and third layers at the second end of the wall comprises applying heat and pressure to the first end of the wall, the first end cap, the second end of the wall, and the second end cap.

[0147] Example 31. The method of any example herein, particularly example 30, wherein applying heat and pressure comprises placing heat shrink tubing around the first end of the wall, the first end cap, the second end of the wall, and the second end cap, and heating the heat shrink tubing.

[0148] Example 32. A medical device of any example herein, particularly any of examples 1-31, wherein the medical device is sterilized.

[0149] In view of the many possible embodiments to 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. I therefore claim all that comes within the scope and spirit of these claims.

Claims

CLAIMS:

1. A medical device for insertion within a portion of a patient’s body, the device comprising: an inflatable balloon having a wall comprising a first layer, a second layer radially outward of the first layer, and a third layer radially outward of the second layer, wherein the first layer and the third layer are not thermally bondable to the second layer, and wherein a first end portion of the first layer is fixed to a first end portion of the third layer and a second end portion of the first layer is fixed to a second end portion of the third layer.

2. The medical device of claim 1, wherein the first end portion of the first layer is bonded to a first surface of the medical device, and the second end portion of the first layer is bonded to a second surface of the medical device.

3. The medical device of any one of claims 1 and 2, wherein the first layer and the third layer comprise a first material, and the second layer comprises a second material that is different from the first material.

4. The medical device of claim 3, wherein the first material comprises a polyamide or co-polyamide.

5. The medical device of any one of claims 3 and 4, wherein the second material comprises a polyethylene terephthalate, polybutylene terephthalate, thermoplastic elastomer copolyester, or combinations thereof.

6. The medical device of any one of claims 3-5, wherein the second material is less compliant than the first material.

7. The medical device of any one of claims 1-6, wherein the first end portion of the first layer is fixed to the first end portion of the third layer via a first end cap thermally bonded to the first end portion of the first layer and the first end portion of the third layer, and wherein the second end portion of the first layer is fixed to the second end portion of the thirdlayer via a second end cap thermally bonded to the second end portion of the first layer and the second end portion of the third layer.

8. The medical device of claim 7, when dependent on any of claims 3-6, wherein the first end cap and the second end cap comprise the first material.

9. A medical device for insertion within a body vasculature, the device comprising: an inflatable balloon having a wall comprising a first layer, a second layer radially outward of the first layer, and a third layer radially outward of the second layer, wherein the balloon further comprises a first end cap and a second end cap, wherein the first end cap is in axial abutment with a first end of the wall and the second end cap is in axial abutment with a second end of the wall; a shaft; and a nose cone, wherein a first end portion of the first layer and the first end cap are bonded to an outer surface of the shaft and a second end portion of the first layer and the second end cap are bonded to an outer surface of the nose cone.

10. The medical device of claim 9, wherein the first end cap is bonded to the first and third layers at a first end of the wall, and the second end cap is bonded to the first and third layers at a second end of the wall.

11. The medical device of any of claims 9 and 10, wherein the first layer, the third layer, and the first and second end caps comprise a first material, and the second layer comprises a second material that is different from the first material.

12. The medical device of claim 11, wherein the first material comprises a polyamide or co-polyamide.

13. The medical device of claim 11, wherein the first material comprises nylon.

14. The medical device of any of claims 11-13, wherein the second material comprises a polyethylene terephthalate, polybutylene terephthalate, thermoplastic elastomer copolyester, or combinations thereof.

15. The medical device of any one of claims 11-14, wherein the second material has a higher stiffness modulus than the first material.

16. The medical device of any one of claims 9-15, wherein the first layer, the third layer, the first end cap, and the second end cap are made of materials that are thermally bondable to each other.

17. The medical device of any of one of claims 9-16, wherein the first end cap and the second end cap are cylindrical.

18. The medical device of any of one of claims 9-17, wherein the first layer, the third layer, the first end cap, and the second end cap seal and encapsulate the second layer.

19. A method of making a medical device, the method comprising: forming an inflatable balloon having a wall comprising a first layer, a second layer radially outward of the first layer, and a third layer radially outward of the second layer, wherein the first layer and third layer are not thermally bondable to the second layer; placing a first end cap in axial abutment with a first end of the wall, wherein the first end cap contacts a first end of the first layer and a first end of the third layer; placing a second end cap in axial abutment with a second end of the wall, wherein the second end cap contacts a second end of the first layer and a second end of the third layer; bonding the first end cap to the first and third layers at the first end of the wall; and bonding the second end cap to the first and third layers at the second end of the wall.

20. The method of claim 19, wherein bonding the first end cap to the first and third layers at the first end of the wall and bonding the second end cap to the first and third layers at the second end of the wall comprises applying heat and pressure to the first end of the wall, the first end cap, the second end of the wall, and the second end cap.

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