Prosthetic medical device delivery system

Abstract

A delivery apparatus for a prosthetic medical device can include a handle, a shaft coupled to the handle, a balloon coupled to a distal end portion of the shaft, a plurality of filaments extending in an axial direction of the delivery apparatus, and a proximal collar coupled to the shaft. The balloon can be in a deflated state and can be configured to be inflated from the deflated state to an inflated state. Each one of the plurality of filaments can include a proximal end portion, a distal end portion, and an intermediate portion disposed between the proximal end portion and the distal end portion. The plurality of filaments can be connected at their proximal ends to the proximal collar.

Description

PROSTHETIC MEDICAL DEVICE DELIVERY SYSTEMCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 730,710, filed on December 11, 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. Tom balloons can be difficult to retrieve.SUMMARY

[0005] Accordingly, a need exists for improved balloons for balloon catheters that are more resistant to tearing and / or easier to retrieve when tom.

[0006] Described herein are balloon catheters configured to deliver a prosthetic medical device (for example, a prosthetic valve, a stent, etc.). The disclosed balloon catheters can, for example, provide for improved retrieval of burst catheter balloons. In some examples, the disclosed balloon catheters can additionally or alternatively include catheter balloons with increased burst pressures. As such, the devices disclosed herein can, among other things, overcome one or more of the deficiencies of known balloon catheters.

[0007] A delivery apparatus can include a handle.

[0008] In some examples, the delivery apparatus can include a shaft coupled to the handle.

[0009] In some examples, the delivery apparatus can include a balloon coupled to a distal end portion of the shaft.

[0010] In some examples, the balloon can be in a deflated state.

[0011] In some examples, the delivery apparatus can include a plurality of filaments extending in an axial direction of the delivery apparatus.

[0012] In some examples, each of the plurality of filaments can include a proximal end portion, a distal end portion, and an intermediate portion disposed between the proximal end portion and the distal end portion.

[0013] In some examples the delivery apparatus can include a proximal collar coupled to the shaft of the delivery apparatus.

[0014] In some examples, the plurality of filaments can be connected at their proximal end portions to the proximal collar.

[0015] In some examples, the balloon can form a plurality of pleats extending in a lengthwise direction of the balloon.

[0016] In some examples, each one of the plurality of pleats can be folded to cover a corresponding one of the plurality of filaments.

[0017] In some examples, the proximal collar can be slidably coupled to the shaft.

[0018] In some examples, the delivery apparatus can further include a distal collar coupled to a distal end portion of the balloon.

[0019] In some examples, a number of the plurality of pleats can be equal to a number of the plurality of filaments.

[0020] In some examples, a delivery apparatus for a prosthetic medical device can include a handle, a shaft coupled to the handle, a balloon in a deflated state, a plurality of filaments extending in an axial direction of the delivery apparatus, and a proximal collar coupled to the shaft of the delivery apparatus. The balloon can be coupled to a distal end portion of the shaft. The balloon can be configured to be inflated from the deflated state to an inflated state. Each of the plurality of filaments can include a proximal end portion, a distal end portion, and an intermediate portion disposed between the proximal end portion and the distal end portion. The plurality of filaments can be connected at their proximal end portions to the proximal collar.

[0021] In some examples, a delivery apparatus can include a handle, a shaft coupled to the handle, a balloon coupled to a distal end portion of the shaft, wherein the balloon can define a plurality of pleats, a plurality of filaments, wherein each filament can extend between a pair of adjacent ones of the plurality of pleats, a proximal collar, wherein the plurality of filaments can be connected at their proximal ends to the proximal collar, and a distal collar, wherein the plurality of filaments can be connected at their distal ends to the distal collar.

[0022] In some examples, a delivery apparatus can include a handle, a shaft coupled to the handle, a deflated balloon coupled to a distal end portion of the handle, wherein the deflated balloon can be configured to be inflatable to an inflated state, a plurality of pleats defined by the deflated balloon, wherein each pleat can be folded to define a radially inwards-facing surface and a radially outwards-facing surface, and a plurality of filaments, wherein the plurality of pleats can be folded such that each filament can be disposed between the radially inwards-facing surface of a first corresponding one of the plurality of pleats and the radially outwards-facing surface of a second, adjacent corresponding one of the plurality of pleats.

[0023] In some examples, a delivery apparatus can include one or more of the components recited in Examples 1-21 below.

[0024] 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, andadvantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0025] FIG. 1 is a perspective view of a prosthetic heart valve, according to one example.

[0026] FIG. 2 is a perspective view of a delivery apparatus for a prosthetic heart valve, according to one example.

[0027] FIG. 3 is a perspective view of a distal end portion of a delivery apparatus that includes a catheter balloon, wherein the catheter balloon is in a deflated state, according to one example.

[0028] FIG. 4 is a perspective view of the distal end portion of the delivery apparatus of FIG. 3, wherein the catheter balloon is in an inflated state.

[0029] FIG. 5 is a cross-sectional view of a distal end portion of a delivery apparatus, wherein the delivery apparatus comprises a catheter balloon defining a plurality of pleats and a plurality of filaments covered by the pleats, according to one example.

[0030] FIG. 6 is a cross-sectional view of the distal end portion of the delivery apparatus of FIG. 5, wherein the catheter balloon is in a semi-inflated state.DETAILED DESCRIPTIONGeneral Considerations

[0031] For puiposes 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.

[0032] Although the operations of some of the disclosed examples are described in a sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless an ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged orperformed 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 implementation and are readily discernible by one of ordinary skill in the art.

[0033] 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.” The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps not expressly referenced. 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. It is further noted that the claims can be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.

[0034] The method(s), techniques, processes, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on any suitable subject (e.g., a living subject (e.g., human, or other animal) or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, or simulator (for example, with body parts, heart, tissue, etc. being simulated), etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.

[0035] 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 motionof the device away from the implantation site and toward the user (for example, out of the subject’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 subject’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0036] Reference throughout this specification to “an implementation” means that a particular feature, structure, or characteristic described in connection with the implementation is included in at least one implementation. Thus, appearances of the phrases “in an implementation” or “in some implementations” in various places throughout this specification are not necessarily all referring to the same implementation or a single exclusive implementation. Furthermore, the particular features, structures, or characteristics described herein may be combined in any suitable manner in one or more implementations.

[0037] The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any aspect described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects. Unless specifically stated otherwise, the term “some” refers to one or more.

[0038] It will be understood that the benefits and advantages described above can relate to one implementation or can relate to several implementations. Aspects described in connection with one implementation are intended to be able to be used with the other implementation. Any explanation in connection with one implementation applies to similar features of the other implementations, and elements of multiple implementations can be combined to form other implementations. The implementations are not limited to those that solve any or all of the stated problems or those that have any or all of the stated benefits and advantages.

[0039] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”Overview of the Disclosed Technology

[0040] 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 orcavity. Some 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.

[0041] During a medical procedure involving a balloon catheter, the 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 subject’s body. A catheter balloon sometimes can rupture or tear during the medical procedure, such as if the balloon is inadvertently overinflated and / or if the inflated balloon contacts irregularly shaped calcified nodules that extend into a native heart valve annulus, which can complicate retrieval and removal of the catheter from the subject’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.

[0042] To address one or more problems of known catheter balloons, it would be desirable to reinforce the balloon of the catheter to prevent tearing. Additionally or alternatively, it would be desirable to configure the balloon catheter to allow for the easy retrieval of tom balloons.Examples of the Disclosed Technology

[0043] FIG. 1 shows an exemplary prosthetic valve 10, according to one example. Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in some 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 subject. 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.

[0044] 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. 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 some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in WIPO Publication No. WO 2020 / 247907, which is incorporated by reference herein. In some examples, 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.

[0045] 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.

[0046] 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 some examples there can be 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 leaflet 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.

[0047] 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 stmts 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 stmts24. In some examples, an angle 30 between the two angled stmts 24, connected at the apex 26, can be in a range of 90 to 120 degrees.

[0048] 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 subject 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.

[0049] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, frame 12) 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 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 F562-02). MP35N™ / UNS R3OO35 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0050] 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 yams or fibers, such as in the fomi 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, terry cloth, fleece, etc. In some examples, the skirts 16 and / or 18 can comprise a fabric without interlaced yarns or fibers or randomly interlaced yams 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).

[0051] Additional details regarding the prosthetic valve 10 and its various components are described in WIPO Publication No. WO 2018 / 222799, which is incorporated by reference herein.Delivery Apparatus

[0052] FIG. 2 shows a delivery apparatus 100, according to an example, that can be used to implant an expandable prosthetic valve (for example, prosthetic valve 10 of FIG. 1 or any of the other prosthetic medical device described herein). In some examples, the delivery apparatus 100 is specifically adapted for use in introducing a prosthetic valve into a heart. Although the specific examples of delivery apparatuses are disclosed herein as configured for use with prosthetic heart valves (for example, the prosthetic heart valve 10 of FIG. 1 or any other prosthetic heart valve disclosed herein), the exemplary delivery apparatus can additionally or alternatively be configured for use with any other prosthetic medical device (for example, a stent, a graft, an stents, an embolic coil, and / or any other implant).

[0053] The delivery apparatus 100 in the illustrated example of FIG. 2 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.

[0054] 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 subject’s body.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] 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.

[0059] In some examples, the distal end portion 118a of the balloon 1 18 can be coupled to a distal end portion 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 portion 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 118bof the balloon is alternatively be referred to herein as a valve mounting portion of the balloon 118.

[0060] 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 1 18 during delivery through the subject’s vasculature.

[0061] 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.

[0062] 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 fluidly coupled 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.

[0063] 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.

[0064] 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 thedistal 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.

[0065] 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. WO 2022 / 046585, which is incorporated by reference herein.

[0066] FIG. 3 is a perspective view of a distal end portion of a delivery apparatus 200 that includes the catheter balloon 118, which is shown in the deflated state. As shown, the delivery apparatus 200 includes the outer shaft 104, the intermediate shaft 106, the inner shaft 108 (best shown in FIG. 4), the balloon 118, and the nose cone 122. In some examples, the delivery apparatus 200 can include any and / or all of the components of the delivery apparatus 100, which are not repeated here for the sake of brevity.

[0067] One exemplary difference between the presently illustrated delivery apparatus 200 and the delivery apparatus 100 of FIG. 2 is that the delivery apparatus 200 includes a plurality of filaments 260 (which are also referred to herein as “strands" and / or “fibers"). The plurality of filaments 260 can include any number of filaments 260 (for example, two, three, four, five, six, seven, eight, nine, ten, at least 2, at least 3, at least 4, at least 5, at least 6, at least 7, at least 8, etc.). The plurality of filaments 260 extend along an axial length of an outer surface of the balloon 118. For example, as shown, each one of the plurality of filaments 260 extends along the entire axial length of the balloon 118, for example, from the distal end portion 118a of the balloon 118 to the proximal end portion 118c of the balloon 118. In some examples, one or more of the plurality of filaments 260 can be longer than the axial length of the balloon 118, for example such that one or more of the plurality of filaments 260 extends from the distal end portion 118a of the balloon 118, over the proximal end portion 118c of the balloon 118, and to the distal end portion of the intermediate shaft 106. In some examples, one or more of the plurality of filaments 260 can extend from the nose cone 122, over the distal end portion 118a of the balloon 118, and to the proximal end portion 118c of the balloon 118. In some examples, the filaments 260 can extend along at least a majority of the length of the balloon 118.

[0068] The plurality of filaments 260 can be formed from a polymeric material, such as PTFE, PET, polypropylene, polyamide, PEEK, polyurethane (such as TPU), etc. In some examples, one or more of the plurality of filaments 260 can be monofilaments. In some examples, the filaments 260 can comprise yarns. In some examples, the filaments 260 can be made of metal (for example, Nitinol or stainless steel), such as in the form of metal wires or cables.

[0069] The plurality of filaments 260 are configured to facilitate retrieval of torn catheter balloons from the subject’s vasculature. For example, if the balloon 118 is tom such that the distal end portion 118a and the proximal end portion 118c of the balloon 118 separate, the tom distal end portion 118a of the balloon 118 can be captured by the plurality of filaments 260 surrounding it. In this way, the plurality of filaments 260 can allow for improved retrieval of torn catheter balloons, thereby reducing the likelihood of clinical sequela.

[0070] In some examples, the plurality of filaments 260 can additionally or alternatively reinforce the balloon 118, thereby allowing the balloon 118 to be inflated to a higher pressure before bursting or tearing than a typical, unreinforced balloon. In this way, the plurality of filaments 260 can reduce the likelihood that the balloon 118 will tear if inadvertently overinflated.

[0071] As shown in FIG. 3, each one of the plurality of filaments 260 includes a distal end portion 260a, an intermediate portion 260b, and a proximal end portion 260c. The distal end portions 260a of the plurality of filaments 260 are shown to be coupled to a distal collar 262, such as by welding or an adhesive. The distal collar 262 is an annular, ring-shaped structure. The distal end portions 260a of the plurality of filaments 260 can be coupled to the distal collar 262 in a radial pattern, for example, an evenly-spaced radial pattern. The distal collar 262 can be configured to fit around the distal end portion 118a of the balloon 118 (for example, the neck formed at the distal end of the balloon 118). In some examples, the distal collar 262 can be additionally or alternatively configured to fit around the nose cone 122. In the illustrated example, the distal collar 262 is configured to be fixed relative to the distal end portion 1 18a of the balloon 118, such that the distal collar 262 does not move in the axial direction relative to the balloon 118 as the balloon 118 is inflated (for example, to expand a prosthetic heart valve mounted to the valve mounting portion 124 of the balloon 118) or deflated. In this way, the distal collar 262 can be prevented from becoming dislodged from the distal end of the delivery apparatus 200. The distal collar 262 can be fixed to the distal end portion 118a of the balloon 118 and / or the nose cone 122 using any suitable techniques or mechanisms, such as anadhesive, welding, or mechanical fasteners. In some examples, the distal collar 262 can instead be movable (for example, slidable) in the axial direction relative to the balloon 118.

[0072] In some examples, in lieu of or in addition to coupling the distal end portions 260a to the distal collar 262, one or more of the distal end portions 260a of the plurality of filaments 260 can be fixed directly to the outer surface of the balloon 118 and / or to the nose cone 122. In some examples, the distal collar 262 is optional and need not be included.

[0073] As further shown in FIG. 3, the proximal ends 260c of the plurality of filaments 260 are coupled to a proximal collar 264, such as by welding or an adhesive. The proximal collar 264 is an annular, ring-shaped structure. The proximal end portions 260c of the plurality of filaments 260 can be coupled to the proximal collar 264 in a radial pattern, for example, an evenly-spaced radial pattern. The proximal collar 264 can be configured to fit around a shaft of the delivery system (for example, the distal end portion of the intermediate shaft 106). In some examples, the proximal collar 264 can additionally or alternatively be configured to fit around the proximal end portion 118c of the balloon 118 (for example, the neck formed at the proximal end of the balloon 118). In the illustrated example, the proximal collar 264 is slidably coupled to the intermediate shaft 106 such that the proximal collar 264 can move in the axial direction relative to the balloon 118. In other words, the proximal collar 264 can “float” over the intermediate shaft 106. Since the surface area of the balloon 118 expands as the balloon 118 is inflated, the plurality of filaments 260 will need to traverse a longer path over the outer surface of the inflated balloon 118 than the outer surface of the deflated balloon 1 18. Allowing at least one of the distal collar 262 and the proximal collar 264 to slide relative to the balloon 118 (and / or the intermediate shaft 106 coupled to the balloon 118) can allow the plurality of filaments 260 to extend over the outer surface of the balloon 118 in the inflated state without excessively tensioning the plurality of filaments 260 and / or allow the plurality of filaments 260 to extend over the outer surface of the balloon 118 in the deflated state without excessive slack. Additionally or alternatively, allowing at least one of the distal collar 262 and the proximal collar 264 to slide relative to the balloon 118 can help with retrieval of the balloon 118 from the subject’s vasculature. In some examples, the filaments 260 do not restrict inflation of the balloon 118 and allow the intermediate portion 118b of the balloon 118 to achieve a cylindrical shape when fully inflated.

[0074] In some examples, one or more pull wires, cables, or tethers 266 can extend from the handle (for example, handle 102) of the delivery apparatus 200 and connect to the distal collar 262 and / or the proximal collar 264. For example, the pull wires 266 can extend from thehandle, through the lumen of the outer shaft 104, and to the proximal collar 264. The distal end portion of each pull wire 266 can be connected to the proximal collar 264. In some examples, the pull wires 266 can be connected to a knob or other actuator of the handle. The user can increase or decrease tension in the pull wires 266 (for example, by rotating the knob or toggling the actuator) to adjust the axial position of the proximal collar 264. In some examples, the user can pull the proximal collar 264 in the proximal direction during retrieval to tension the plurality of filaments 260 and tension them against the outer surface of the balloon 1 18. This can help ensure that the plurality of filaments 260 do not become tangled or caught on the subject’s vasculature during retrieval. The pull wires 266 can also facilitate retrieval of the balloon 118 and the plurality of filaments 260 back through an introducer sheath when the delivery apparatus 200 is removed from the subject’s body.

[0075] In some examples, instead of (or in addition to the) coupling the proximal end portions 260c to the proximal collar 264, one or more of the proximal end portions 260c of the plurality of filaments 260 can be fixed directly to the outer surface of the balloon 1 18 or to the intermediate shaft 106. In some examples, the distal end portions 260a of the plurality of filaments 260 can be coupled to the distal collar 262, and the distal collar 262 can be slidable relative to the balloon 118. In some examples, any combination of the distal end portions 260a, the intermediate portions 260b, and / or the proximal end portions 260c of the plurality of filaments 260 can be fixed to the outer surface of the balloon 118.

[0076] The plurality of filaments 260 can be coupled to the distal collar 262 and / or the proximal collar 264 in any suitable manner, including but not limited to adhesives, mechanical fasteners, ultrasonic welds, etc. In some examples, any combination of the plurality of filaments 260, the distal collar 262, and / or the proximal collar 264 can be integrally formed (for example, molded) as a single structure.

[0077] As further shown in FIG. 3, in some examples, the intermediate portions 260b of the plurality of filaments 260 are not fixed to the balloon 118 (for example, the outer surface of the balloon 118). This allows for the plurality of filaments 260 to better accommodate the inflation and deflation of the balloon 118. In some examples, the intermediate portions 260b (or a portion thereof) of one or more of the plurality of filaments 260 can be embedded in a sidewall of the balloon 118.

[0078] The distal collar 262 and / or the proximal collar 264 can comprise and / or be formed from, for example, a metal alloy, a polymer, or any combination thereof. Example metal alloyscan comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, stainless steel, cobalt-chromium, nickel-cobalt-chromium, and nickel-cobalt-chromium- molybdenum alloy. In some examples, the distal collar 262 and / or the proximal collar 264 can comprise and / or be from of the same material as the frame 12. Example polymers can include PTFE, PET, polypropylene, polyamide, PEEK, polyurethane (such as TPU), etc. In some examples, the distal collar 262 and / or the proximal collar 264 can comprise and / or be formed from of the same material as the plurality of filaments 260. In some examples, the distal collar 262 and / or the proximal collar 264 can be integrally formed (for example, molded) with the plurality of filaments 260.

[0079] FIG. 5 is a cross-sectional view of a distal end portion of a delivery apparatus 300, according to one example. The presently illustrated delivery apparatus 300 shares certain similarities with the previously disclosed delivery apparatus 200. For example, the delivery apparatus 300 can include the outer shaft 104, the intermediate shaft 106, the inner shaft 108, the nose cone 122, the plurality of filaments 260, the distal collar 262, and the proximal collar 264. The delivery apparatus 300 also can include any of the components of the delivery apparatus 100. Additionally, the delivery apparatus 300 includes a balloon 318 that shares certain similarities with the balloon 118 of FIGS. 2-4. In some examples, the balloon 318 can be the same as the balloon 118 except for the folding pattern described below. The view illustrated in FIG. 5 is a cross-section of the balloon 318 taken along a line similar to the reference line A-A shown in FIG. 3.

[0080] One exemplary difference between the presently illustrated balloon 318 and the balloon 118 of FIGS. 2-4 is that the balloon 318 (which is also referred to herein as a “pleated balloon’’) in a deflated state defines a plurality of longitudinal pleats 370 that extend in a lengthwise direction of the balloon. Each pleat 370 is a portion of the balloon 318 that is folded in a circumferential direction to define a radially inwards-facing surface 372 and a radially outwards -facing surface 374. The plurality of pleats 370 are spaced uniformly apart from each other in the circumferential direction of the balloon 318. In some examples, the plurality of pleats 370 can be unevenly spaced apart from each other in the circumferential direction. As shown, the balloon 318 is folded to define eight pleats 370. In some examples, the balloon 318 can be folded to define any number (for example, two, three, four, five, six, seven, nine, ten, at least 2, at least 3, at least 4, at least 5, at least 6, at least 7, at least 8, etc.) of pleats 370. When the balloon 318 is inflated to an inflated state, the plurality of pleats 370 unfold. In someexamples, when the balloon 318 is inflated to the inflated state, the plurality of pleats 370 unfold, thereby resulting in a smooth, cylindrical outer surface.

[0081] As shown, when the balloon 318 is in the deflated state, each pleat 370 is folded to at least partially overlap an adjacent one of the plurality of pleats 370. For example, as shown, each pleat 370 can be a knife pleat folded in the circumferential direction (for example, a clockwise direction) to at least partially overlap an adjacent pleat 370. Thus, the balloon 318 in the deflated state can have a spiral-shaped cross -section.

[0082] As further shown, when the balloon 318 is in the deflated state, each one of the plurality of pleats 370 can be folded to cover a corresponding one of the plurality of filaments 260. For example, each filament 260 can be placed between the radially inwards-facing surface 372 of a first corresponding pleat 370 and the radially outwards-facing surface 374 of a second corresponding pleat 370. The first and second corresponding pleats 370 can be a pair of adjacent ones of the plurality of pleats 370. The first corresponding pleat 370 can then be folded in the circumferential direction over the filament 260 to cover the filament 260.

[0083] In some examples, folding the plurality of pleats 370 over the plurality of filaments 260 can help prevent the plurality of filaments 260 from becoming entangled with one another during an implantation procedure. In some examples, folding the pleats 370 over the filaments 260 can additionally or alternatively reduce the likelihood that the plurality of filaments 260 will get caught on another component of the delivery apparatus 300 or a portion of the subject' s vasculature during the implantation procedure.

[0084] As shown, the number of the plurality of filaments 260 equals the number of the plurality of pleats 370, such that each filament 260 is covered by a corresponding pleat 370 and each pleat 370 covers a corresponding filament 260. In some examples, the number of pleats 370 can be greater than the number of filaments 260, such that some pleats 370 do not cover a corresponding filament 260. In some examples, the number of filaments 260 can be greater than the number of pleats 370, such that two or more filaments 260 can be covered by a single pleat 370.

[0085] FIG. 6 is a cross-sectional view of the distal end portion of the delivery apparatus 300, wherein the balloon 318 is in a semi-inflated state. As the balloon 318 is inflated from the deflated state to the inflated state, for example, to expand a prosthetic valve mounted to a valve mounting portion of the balloon 318, the plurality of pleats 370 unfurl to uncover the plurality of filaments 260.

[0086] In some examples, the pleats 370 can beneficially help control the circumferential spacing of the plurality of filaments 260 when the balloon 318 is in the deflated state. This can help ensure that the plurality of filaments 260 do not become tangled prior to or during delivery. Additionally or alternatively, the pleats 370 can cover the plurality of filaments 260, thereby further minimizing contact between the subject’s vasculature and the plurality of filaments 260.

[0087] 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

[0088] 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.

[0089] 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.

[0090] 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.

[0091] 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.

[0092] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a subject’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

[0093] 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.

[0094] Example 1. A delivery apparatus for a prosthetic medical device can include a handle, a shaft coupled to the handle, a balloon in a deflated state, a plurality of filaments extending in an axial direction of the delivery apparatus, and a proximal collar coupled to the shaft of the delivery apparatus. The balloon can be coupled to a distal end portion of the shaft. The balloon can be configured to be inflated from the deflated state to an inflated state. Each of the plurality of filaments can include a proximal end portion, a distal end portion, and an intermediate portion disposed between the proximal end portion and the distal end portion. The plurality of filaments can be connected at their proximal end portions to the proximal collar.

[0095] Example 2. The delivery apparatus of any example herein, particularly Example 1, wherein the balloon can form a plurality of pleats extending in a lengthwise direction of the balloon.

[0096] Example 3. The delivery apparatus of any example herein, particularly Example 2, wherein each one of the plurality of pleats can be folded to cover a corresponding one of the plurality of filaments.

[0097] Example 4. The delivery apparatus of any example herein, particularly any one of Examples 1-3, wherein the proximal collar can be slidably coupled to the shaft.

[0098] Example 5. The delivery apparatus of any example herein, particularly any one of Examples 1-4, which can further include a distal collar coupled to a distal end portion of the balloon, wherein the plurality of filaments can be connected at their distal ends to the distal collar.

[0099] Example 6. The delivery apparatus of any example herein, particularly Example 5, wherein the distal collar can be fixedly coupled to the distal end portion of the balloon.

[0100] Example 7. The delivery apparatus of any example herein, particularly any one of Examples 1-6, wherein the intermediate portions of the plurality of filaments are not fixed to the balloon.

[0101] Example 8. The delivery apparatus of any example herein, particularly any one of Examples 1-6, wherein the plurality of filaments can include eight filaments.

[0102] Example 9. A delivery apparatus can include a handle, a shaft coupled to the handle, a balloon coupled to a distal end portion of the shaft, wherein the balloon can define a plurality of pleats, a plurality of filaments, wherein each filament can extend between a pair of adjacent ones of the plurality of pleats, a proximal collar, wherein the plurality of filaments can be connected at their proximal ends to the proximal collar, and a distal collar, wherein the plurality of filaments can be connected at their distal ends to the distal collar.

[0103] Example 10. The delivery apparatus of any example herein, particularly Example 9, wherein the plurality of pleats can be spaced uniformly apart from each other in a circumferential direction.

[0104] Example 1 1. The delivery apparatus of any example herein, particularly Example 9, wherein the plurality of filaments can be spaced uniformly apart from each other in a circumferential direction.

[0105] Example 12. The delivery apparatus of any example herein, particularly any one of Examples 9-11, wherein a number of the plurality of pleats can be equal to a number of the plurality of filaments.

[0106] Example 13. The delivery apparatus of any example herein, particularly any one of Examples 9-12, wherein each one of the plurality of pleats can be folded to at least partially overlap an adjacent one of the plurality of pleats.

[0107] Example 14. The delivery apparatus of any example herein, particularly Example 13, wherein each one of the plurality of pleats can be circumferentially folded to cover a corresponding one of the plurality of filaments.

[0108] Example 15. The delivery apparatus of any example herein, particularly any one of Examples 9-14, wherein the plurality of pleats can be knife pleats.

[0109] Example 16. A delivery apparatus can include a handle, a shaft coupled to the handle, a deflated balloon coupled to a distal end portion of the handle, wherein the deflated balloon can be configured to be inflatable to an inflated state, a plurality of pleats defined by the deflated balloon, wherein each pleat can be folded to define a radially inwards-facing surface and a radially outwards-facing surface, and a plurality of filaments, wherein the plurality of pleats can be folded such that each filament can be disposed between the radially inwards-facing surface of a first corresponding one of the plurality of pleats and the radially outwards- facing surface of a second, adjacent corresponding one of the plurality of pleats.

[0110] Example 17. The delivery apparatus of any example herein, particularly Example 16, wherein the plurality of pleats can be folded such that the deflated balloon has a spiral-shaped cross -sect! on.

[0111] Example 18. The delivery apparatus of any example herein, particularly any one of Examples 16-17, further including a proximal collar that can be slidable relative to the shaft, wherein each reinforcement fiber can include a proximal end portion coupled to the proximal collar.

[0112] Example 19. The delivery apparatus of any example herein, particularly any one of Examples 16-18, further including a distal collar that can be fixed relative to a distal end portion of the balloon, wherein each reinforcement fiber can include a proximal end portion coupled to the distal collar.

[0113] Example 20. The delivery apparatus of any example herein, particularly any one of Examples 16-19, wherein the deflated balloon can include a valve mounting portion configured to receive a prosthetic heart valve.

[0114] Example 21. The delivery apparatus of any example herein, wherein the delivery apparatus can be sterilized.

[0115] Example 22. A method of sterilizing any of the delivery apparatuses described herein.

[0116] 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 catheter can be combined with any one or more features of another balloon catheter.

[0117] 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

What is claimed is:

1. A delivery apparatus for a prosthetic medical device, the delivery apparatus comprising: a handle; a shaft coupled to the handle; a balloon in a deflated state, wherein: the balloon is coupled to a distal end portion of the shaft, and the balloon is configured to be inflated from the deflated state to an inflated state; a plurality of filaments extending in an axial direction of the delivery apparatus, each comprising a proximal end portion, a distal end portion, and an intermediate portion disposed between the proximal end portion and the distal end portion; and a proximal collar coupled to the shaft of the delivery apparatus, wherein the plurality of filaments are connected at their proximal end portions to the proximal collar.

2. The delivery apparatus of claim 1, wherein the balloon forms a plurality of pleats extending in a lengthwise direction of the balloon.

3. The delivery apparatus of claim 2, wherein each one of the plurality of pleats is folded to cover a corresponding one of the plurality of filaments.

4. The delivery apparatus of any one of claims 1-3, wherein the proximal collar is slidably coupled to the shaft.

5. The delivery apparatus of any one of claims 1-4, further comprising a distal collar coupled to a distal end portion of the balloon, wherein the plurality of filaments are connected at their distal ends to the distal collar.

6. The delivery apparatus of claim 5, wherein the distal collar is fixedly coupled to the distal end portion of the balloon.

7. The delivery apparatus of any one of claims 1-6, wherein the intermediate portions of the plurality of filaments are not fixed to the balloon.

8. The delivery apparatus of any one of claims 1-6, wherein the plurality of filaments includes eight filaments.

9. A delivery apparatus comprising: a handle; a shaft coupled to the handle; a balloon coupled to a distal end portion of the shaft, wherein the balloon defines a plurality of pleats; a plurality of filaments, wherein each filament extends between a pair of adjacent ones of the plurality of pleats; a proximal collar, wherein the plurality of filaments are connected at their proximal ends to the proximal collar; and a distal collar, wherein the plurality of filaments are connected at their distal ends to the distal collar.

10. The delivery apparatus of claim 9, wherein the plurality of pleats are spaced uniformly apart from each other in a circumferential direction.

11. The delivery apparatus of claim 9, wherein the plurality of filaments are spaced uniformly apart from each other in a circumferential direction.

12. The delivery apparatus of any one of claims 9-11, wherein a number of the plurality of pleats is equal to a number of the plurality of filaments.

13. The delivery apparatus of any one of claims 9-12, wherein each one of the plurality of pleats is folded to at least partially overlap an adjacent one of the plurality of pleats.

14. The delivery apparatus of claim 13, wherein each one of the plurality of pleats is circumferentially folded to cover a corresponding one of the plurality of filaments.

15. The delivery apparatus of any one of claims 9- 14, wherein the plurality of pleats are knife pleats.

16. A delivery apparatus comprising: a handle; a shaft coupled to the handle; a deflated balloon coupled to a distal end portion of the handle, wherein the deflated balloon is configured to be inflatable to an inflated state; a plurality of pleats defined by the deflated balloon, wherein each pleat is folded to define a radially inwards-facing surface and a radially outwards-facing surface; and a plurality of filaments, wherein the plurality of pleats are folded such that each filaments is disposed between the radially inwards-facing surface of a first corresponding one of the plurality of pleats and the radially outwards-facing surface of a second, adjacent corresponding one of the plurality of pleats.

17. The delivery apparatus of claim 16, wherein the plurality of pleats are folded such that the deflated balloon has a spiral-shaped cross-section.

18. The delivery apparatus of any one of claims 16-17, further comprising a proximal collar that is slidable relative to the shaft, wherein each reinforcement fiber includes a proximal end portion coupled to the proximal collar.

19. The delivery apparatus of any one of claims 16-18, further comprising a distal collar that is fixed relative to a distal end portion of the balloon, wherein each reinforcement fiber includes a proximal end portion coupled to the distal collar.

20. The delivery apparatus of any one of claims 16-19, wherein the deflated balloon comprises a valve mounting portion configured to receive a prosthetic heart valve.

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