Medical balloons with polymeric retaining structures

Abstract

An inflatable medical balloon comprising a wall and a polymeric retaining structure fixed to an outer surface of the wall of the balloon is disclosed. The retaining structure comprises a plurality of intersecting stmts and at least one shoulder protrading radially outward from an outer surface of the balloon wall. The polymeric retaining structure further comprises a plurality of longitudinal ribs, in some instances, protrading radially outward from a central portion of the balloon wall. The polymeric retaining structure comprising the plurality of intersecting struts, at least one shoulder, and, in some cases, the plurality of longitudinal ribs can be integrally formed as a single component with the balloon wall or formed separately and fused to the balloon wall.

Description

THVMC-24095W001MEDICAL BALLOONS WITH POLYMERIC RETAINING STRUCTURESCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U. S. Provisional Patent ApplicationNo. 63 / 775,035, filed March 20, 2025, which is incorporated by reference herein.FIELD

[0002] The present disclosure relates to medical balloons with polymeric retaining structures joined to outer walls of the balloons.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 (e.g., 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.

[0004] In a specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through a subject’s vasculature (e.g., through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted. Inflatable medical balloons can be used in some instances to deploy or implant other implantable medical devices, such as for example, stents or grafts.

[0005] Inflatable medical balloons can be tightly folded and collapsed to a small profile for advancement through a subject’s vasculature to a treatment site. At the treatment site, the inflatable medical balloons can be radially expanded into a deployed state, for example, for deploying a prosthetic implant mounted thereto.THVMC-24095W001SUMMARY

[0006] Described herein are prosthetic implants (such as, for example, prosthetic heart valves), delivery apparatuses, and methods for implanting prosthetic implants. Also disclosed herein are inflatable medical balloons with retaining structures configured to secure prosthetic implants mounted onto the balloons. In some examples, the retaining structures are made of polymeric materials that can be joined, fused, or integrally formed into walls of the balloons. The disclosed inflatable medical balloons with polymeric retaining structures can, in some examples, provide simplified manufacturing by reducing the number of parts for assembly during balloon construction. In some examples, fabricating the retaining structures from polymeric materials can reduce material costs.

[0007] An inflatable medical balloon can comprise a wall and an implant retaining structure joined or fixed to an outer surface of the wall of the balloon. In addition to these features, an inflatable medical balloon can further comprise one or more of the features disclosed herein.

[0008] In some examples, the wall can extend from a distal end to a proximal end of the balloon and can comprise a proximal end portion, a distal end portion, and a central portion extending from the proximal end portion to the distal end portion.

[0009] In some examples, the retaining structure can comprise a plurality of intersecting struts protruding radially outward from the proximal end portion, the distal end portion, or both the proximal and distal end portions of the wall.

[0010] In some examples, the retaining structure can comprise a plurality of shoulders disposed adjacent a proximal end of the central portion of the wall, a distal end of the central portion of the wall, or both the proximal and distal ends of the central portion of the wall, wherein each shoulder of the plurality of shoulders can protrude radially outward from the outer surface of the wall.

[0011] In some examples, the retaining structure can comprise at least one shoulder protruding radially outward from a distal end of the central portion of the wall and at least one shoulder protruding radially outward from a proximal end of the central portion of the wall.

[0012] In some examples, the retaining structure can further comprise a plurality of longitudinal ribs protruding radially outward from the central portion of the wall andTHVMC-24095W001extending along a direction of a longitudinal axis of the balloon, wherein the longitudinal ribs of the plurality of longitudinal ribs can be spaced apart from one another in a circumferential direction around the balloon.

[0013] In some examples, the retaining structure can radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0014] In some examples, the plurality of longitudinal ribs can be connected to the plurality of intersecting struts at the distal and proximal ends of the central portion of the wall.

[0015] In some examples, each longitudinal rib of the plurality of longitudinal ribs can have a distal end and a proximal end, and the shoulders of the plurality of shoulders can protrude radially outward from the distal and proximal ends of at least one of the plurality of longitudinal ribs.

[0016] In some examples, the shoulders of the plurality of shoulders can protrude radially outward from the distal and proximal ends of each longitudinal rib of the plurality of longitudinal ribs.

[0017] In some examples, the plurality of intersecting struts are joined by one or more zigzag shaped struts.

[0018] In some examples, the wall and the retaining structure can comprise and / or be formed from the same polymer.

[0019] In some examples, the retaining structure can be integrally formed with the wall.

[0020] In some examples, the retaining structure can be integrally molded with the wall of the balloon.

[0021] In some examples, the retaining structure can be fused to the wall of the balloon.

[0022] In some examples, the retaining structure can be adhesively bonded to an outer surface of the wall of the balloon.

[0023] In some examples, the at least one shoulder can have a greater radial thickness than a radial thickness of the longitudinal ribs.THVMC-24095W001

[0024] In some examples, the at least one shoulder can have a radial thickness that is greater than a radial thickness of the plurality of intersecting struts.

[0025] In some examples, the prosthetic implant can be a prosthetic valve and the at least one shoulder can retain the prosthetic valve in an axial position on the balloon.

[0026] In some examples, an inflatable medical balloon comprises a wall extending from a distal end to a proximal end of the balloon, wherein the wall comprises a proximal end portion, a distal end portion, and a central portion extending from the proximal end portion to the distal end portion; and a polymeric retaining structure fixed to an outer surface of the wall of the balloon, wherein the retaining structure comprises: a plurality of intersecting struts protruding radially outward from the proximal end portion, the distal end portion, or both the proximal and distal end portions of the wall; and a plurality of shoulders disposed adjacent a proximal end of the central portion of the wall, a distal end of the central portion of the wall, or both the proximal and distal ends of the central portion of the wall, wherein each shoulder of the plurality of shoulders protrudes radially outward from the outer surface of the wall.

[0027] In some examples, an inflatable medical balloon comprises one or more of the features recited in Examples 1-9 and 32 below.

[0028] A delivery apparatus for a prosthetic implant can comprise a shaft and an inflatable medical balloon having a distal end and a proximal end, where the balloon can be coupled to a distal end portion of the shaft. In addition to these components, a delivery apparatus can further comprise one or more of the components and / or features disclosed herein.

[0029] In some examples, a delivery apparatus can comprise the balloon comprising polymeric retaining structures fixed to the wall of the balloon.

[0030] In some examples, a delivery apparatus can comprise the balloon comprising polymeric retaining structures integrated directly into the wall of the balloon.

[0031] In some examples, a delivery apparatus can comprise the balloon comprising the implant retaining structure joined to the outer surface of the wall of the balloon.

[0032] In some examples, a delivery apparatus for a prosthetic implant comprises a shaft; and an inflatable medical balloon having a distal end and a proximal end, wherein the balloon is coupled to a distal end portion of the shaft and comprises: a wall extending from the distalTHVMC-24095W001end of the balloon to the proximal end of the balloon, wherein the wall comprises a proximal end portion, a distal end portion, and a central portion extending from the proximal end portion to the distal end portion; and a polymeric outer structure integrated directly into the wall of the balloon, wherein the outer structure comprises intersecting struts protruding radially outward from the proximal end portion, the distal end portion, or both the proximal and distal end portions of the wall.

[0033] In some examples, a delivery apparatus for delivering a prosthetic implant through vasculature of a subject comprises a shaft; and an inflatable medical balloon having a distal end and a proximal end, wherein the balloon is coupled to a distal end portion of the shaft and comprises: a wall extending from the distal end of the balloon to the proximal end of the balloon; and an implant retaining structure joined to an outer surface of the wall of the balloon, wherein the implant retaining structure secures the prosthetic implant on the balloon and comprises: a plurality of intersecting struts protruding radially outward from a distal end portion of the wall and a proximal end portion of the wall; and at least one shoulder protruding radially outward from the wall.

[0034] In some examples, a delivery apparatus for delivering a prosthetic implant through vasculature of a subject comprises a shaft; and an inflatable medical balloon having a distal end and a proximal end, wherein the balloon is coupled to a distal end portion of the shaft and comprises: a wall extending from the distal end of the balloon to the proximal end of the balloon; and an implant retaining structure joined to an outer surface of the wall of the balloon, wherein the implant retaining structure secures the prosthetic implant on the balloon and comprises: a plurality of intersecting struts protruding radially outward from a distal end portion of the wall and a proximal end portion of the wall; and at least one shoulder protruding radially outward from the wall.

[0035] In some examples, a delivery apparatus comprises one or more of the components recited in Examples 10-26 below.

[0036] A method of forming a medical balloon can comprise forming a wall from a polymer and forming a retaining structure from a polymer. In addition to these steps, method of forming a medical balloon can further comprise one or more of the steps disclosed herein.THVMC-24095W001

[0037] In some examples, a method of forming a medical balloon can further comprise molding the retaining structure as part of the wall of the balloon.

[0038] In some examples, a method of forming a medical balloon can further comprise fusing the retaining structure with the wall of the balloon using heat welding or bonding.

[0039] In some examples, a method of forming a medical balloon can further comprise insert-molding the retaining structure into the wall of the balloon.

[0040] In some examples, a method of forming a medical balloon comprises forming a wall from a polymer; and forming a retaining structure from a polymer, wherein the retaining structure comprises a plurality of intersecting struts and a plurality of shoulders joined to an outer surface of the wall and protruding radially outward therefrom.

[0041] In some examples, a method of forming a medical balloon comprises one or more of the steps recited in Examples 27-31 and 33 below.

[0042] In some examples, an inflatable medical balloon comprises a wall extending from a distal end of the balloon to a proximal end of the balloon, wherein the wall comprises a proximal end portion, a distal end portion, and a central portion extending from the proximal end portion to the distal end portion; and a polymeric retaining structure coupled to at least a portion of the wall and protruding radially outward from at least the portion of the wall, wherein the polymeric retaining structure comprises: a plurality of intersecting struts; and one or more shoulders.

[0043] In some examples, each of the one or more shoulders protrudes radially outward further than the plurality of intersecting struts.

[0044] In some examples, the at least the portion of the wall comprises at least one of the proximal end portion and the distal end portion.

[0045] In some examples, the at least the portion of the wall comprises the central portion.

[0046] In some examples, the polymeric retaining structure further comprises a plurality of longitudinal ribs extending along a direction of a longitudinal axis of the balloon, wherein the longitudinal ribs of the plurality of longitudinal ribs are spaced apart from one another in a circumferential direction around the balloon.

[0047] In some examples, the intersecting struts of the plurality of intersecting struts are joined by one or more zig-zag shaped struts.THVMC-24095W001

[0048] In some examples, the polymeric retaining structure is integrally formed with the wall.

[0049] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0050] FIG. 1 is a side view of a prosthetic heart valve, according to an example.

[0051] FIG. 2A is a side view of a delivery apparatus for a prosthetic heart valve, according to an example, where the prosthetic heart valve is shown crimped in an on-balloon delivery configuration.

[0052] FIG. 2B is a side view of a distal end portion of the delivery apparatus of FIG. 2A, according to another example, where the prosthetic heart valve is shown crimped in an off-balloon delivery configuration.

[0053] FIG. 3 is a side view of an inflatable medical balloon, according to an example, where the balloon comprises longitudinal ribs, intersecting struts, and shoulders fixed to an outer surface of the balloon wall.

[0054] FIG. 3A is a cross-sectional view of the balloon taken along line 3A-3A of FIG. 3, showing a radial thickness and width of an intersecting strut on the balloon wall.

[0055] FIG. 3B is a cross-sectional view of the balloon taken along line 3B-3B of FIG. 3, showing a radial thickness and width of a longitudinal rib on the balloon wall.

[0056] FIG. 3C is a cross-sectional view of the balloon taken along line 3C-3C of FIG. 3, showing a radial thickness of a shoulder relative to a radial thickness of a longitudinal rib and the balloon wall.THVMC-24095W001

[0057] FIG. 3D is an alternative cross-sectional view for FIG. 3C for a balloon without longitudinal ribs, showing a radial thickness of a shoulder relative to the outer surface of the balloon wall.

[0058] FIG. 4 is an enlarged detail view of the encircled region of the balloon of FIG. 3, showing the longitudinal ribs, intersecting struts, and shoulders fixed to the outer surface of the balloon wall.

[0059] FIG. 5 is a side view of a distal end portion of the delivery apparatus of FIG. 2A comprising the balloon of FIG. 3, according to an example, where the balloon is shown in an inflated state with the prosthetic implant of FIG. 1 mounted thereto.DETAILED DESCRIPTIONGeneral Considerations

[0060] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatuses, 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, apparatuses, 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.

[0061] 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.THVMC-24095W001

[0062] 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” 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.

[0063] Groupings of alternative elements or implementations of the disclosure herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all groups used in the appended claims.

[0064] 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.

[0065] 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 aTHVMC-24095W001device is motion of the device away from the implantation site and toward the user (e.g., 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 (e.g., 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.

[0066] The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain implementations herein is intended merely to better illuminate the devices, apparatus, systems, and methods disclosed herein and does not pose a limitation on the scope of the disclosure otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the disclosure.

[0067] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”

[0068] Unless the context dictates the contrary, all ranges set forth herein should be interpreted as being inclusive of their endpoints and open-ended ranges should be interpreted to include only commercially practical values. Similarly, all lists of values should be considered as inclusive of intermediate values unless the context indicates the contrary. Overview of the Disclosed Technology

[0069] As introduced above, prosthetic implants (for example, prosthetic valves, stents, and grafts) can be mounted in a crimped state around a deflated balloon of a delivery apparatus for travel through a body to an implantation site. Retaining features or structures can be arranged on the balloon for assisting in retaining a prosthetic implant, such as a prosthetic valve, on the balloon as the prosthetic implant is advanced through a subject’s vasculature and deployed at an implantation site via inflation of the balloon. As used herein, the term “subject” can refer to any of a variety of subjects, such as a living subject (e.g., a human subject or a non-human subject) or a simulation. In various examples, the subject may be a human patient.

[0070] Described herein are inflatable medical balloons comprising polymeric retaining structures fixed to outer surfaces of the balloon walls. In some examples, a polymeric retaining structure can comprise intersecting struts, shoulders, and, in some instances, longitudinal ribs radially protruding outward from an outer surface of a balloon wall. The polymeric retaining structure can aid in securing a prosthetic implant in place on the balloon.THVMC-24095W001In some examples, the retaining structure can further provide structural resiliency to the inflatable balloon and thus improve the ability of the balloon to maintain shape during expansion, as well as to improve the ability of the balloon to revert to a compact state once deflated to facilitate removal of the delivery apparatus from the subject’s body. In some examples, the retaining structures can minimize or prevent propagation of a tear in the balloon in a circumferential and / or a longitudinal direction in the event the balloon bursts for over-pressurization.

[0071] In some examples, the polymeric retaining structure can be integrally molded or insert-molded into the balloon wall. In some examples, the polymeric retaining structure can comprise materials that can be fused, welded, or bonded to the balloon wall.

[0072] In an example, a prosthetic implant can be a prosthetic heart valve as seen in FIG. 1. FIGS. 2A-2B illustrate examples of a delivery apparatus for a prosthetic heart valve, where the delivery apparatus comprises a balloon catheter with an inflatable balloon. FIGS. 3-4 show an inflatable balloon, according to an example, where the balloon comprises a fused, bonded or integrated polymeric retaining structure for securing a prosthetic heart valve, as seen in FIG. 5.Examples of the Disclosed Technology

[0073] Prosthetic implants (such as, for example, prosthetic valves, stents, and grafts) disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic implants can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a subject’s vasculature on the delivery apparatus. The prosthetic implants can be expanded to the radially expanded state once the prosthetic implants reach an implantation site. The prosthetic implants 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 below. Although the examples described herein are directed toward prosthetic heart valves, it is appreciated that the delivery procedures and apparatuses can be applied to other prosthetic implants, such as for example, stents or grafts.

[0074] FIG. 1 shows a prosthetic implant in the form of a prosthetic heart valve 10 (which is also referred to herein as a “prosthetic valve”), according to an example, where the prostheticTHVMC-24095W001valve 10 is shown in an expanded configuration. 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 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.

[0075] 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 an example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U. S. Publication No. 2017 / 0231756, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020 / 247907, which is incorporated 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. This and all other extrinsic materials discussed herein, including publications, patent applications, and patents, are incorporated by reference in their entirety.

[0076] Referring to FIG. 1, 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.

[0077] 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 otherTHVMC-24095W001examples 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.

[0078] The frame 12 can be radially compressible (collapsible) and expandable, for example, into the expanded configuration shown in FIG. 1. The frame 12 can comprise a plurality of interconnected struts 24 and a plurality of apices 26 that are spaced circumferentially apart at the inflow end portion and the outflow end portion of the frame 12 (only the apices 26 at the outflow end portion are visible in FIG. 1). Each apex 26 is formed at a junction between two angled struts 24 at either the inflow end portion or the outflow end portion. FIG. 1 depicts a 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.

[0079] 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.

[0080] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, frame 12) include, metal alloys, polymers, or combinationsTHVMC-24095W001thereof. 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 cobaltchromium. 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 R20035 (covered by ASTM F562-02). MP35N™ / UNS R20035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0081] 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 yams 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 nonfabric 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).

[0082] Additional details regarding the prosthetic valve 10 and its various components are described in PCT Publication No. WO2018 / 222799, which is incorporated by reference herein.

[0083] FIG. 2 A shows a delivery apparatus 100, according to an example, that can be used to implant an expandable prosthetic valve (for example, the prosthetic valve 10 of FIG. 1 or anyTHVMC-24095W001other prosthetic implant 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 or implant (for example, a stent, a graft, an embolic coil, and / or any other implant).

[0084] The delivery apparatus 100 in the illustrated example of FIG. 2 A 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. 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.

[0085] 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. 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.

[0086] 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 (also referred to herein as a “catheter balloon,” “balloon,” or “inflatable medical balloon”) 118 of the delivery apparatus 100. A distal endTHVMC-24095W001portion of the inner shaft 108 can extend distally beyond the distal end portion of the intermediate shaft 106.

[0087] 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. In some examples, the distal end portion 118a of the balloon 118 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.

[0088] 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 is alternatively referred to herein as a valve mounting portion or a working portion of the balloon 118.

[0089] A balloon shoulder assembly, including the distal shoulder 126, can be configured to maintain the prosthetic heart valve 150 (or other medical device) at a fixed position on the balloon 118 during delivery through the subject’s vasculature.

[0090] 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.THVMC-24095W001

[0091] 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.

[0092] 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.

[0093] 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, 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 have 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.

[0094] 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 PCT Publication No.WO2022 / 046585, which is incorporated by reference herein.

[0095] FIG. 2 A shows an example of the delivery apparatus 100 being used for “on-balloon” delivery with the prosthetic valve 150 in an on-balloon configuration. For such an on-balloonTHVMC-24095W001delivery, 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 subject’s vasculature.

[0096] FIG. 2B shows an example of the delivery apparatus 100 being used for “off-balloon” delivery with the prosthetic valve 150 in an off-balloon configuration. For such an off-balloon delivery, the prosthetic valve 150 is radially crimped offset from the valve mounting portion 124 (which is also referred to herein as an “offset position”), such as on the intermediate shaft 106 and / or on a proximal end portion of the balloon 118. The delivery apparatus 100 and the prosthetic valve 150 can be inserted through an introducer sheath and into the subject’s vasculature with the prosthetic valve 150 in this offset position. Once inside the subject’s vasculature (for example, within the descending aorta), the prosthetic valve 150 can be moved from the offset position to the valve mounting portion 124 of the balloon 118. This can be accomplished by moving the intermediate shaft 106 proximally relative to the outer shaft 104 or moving the outer shaft 104 distally relative to the intermediate shaft 106 while applying a distally-directed force against a proximal end 150p of the prosthetic valve 150 with a distal end of the distal tip portion 128. In some examples, the adjustment mechanism 161 can be used to move the intermediate shaft 106 relative to the outer shaft 104 for repositioning the prosthetic valve 150. Thereafter, the delivery apparatus 100 can be further advanced to the target implantation site (for example, the native aortic annulus) and the prosthetic valve 150 can be deployed.

[0097] FIG. 2B also shows a pull wire 166 (which can extend through a lumen of the shaft 104) having a distal end 166d that is fixed relative to a steerable section 164 of the outer shaft 104. The proximal end of the pull wire 166 can be operatively connected to the adjustment knob 160 (FIG. 2B) for adjusting the tension in the pull wire 166 for controlling the curvature of the steerable section 164 of the outer shaft 104. Further details regarding a delivery apparatus used for off-balloon delivery of a prosthetic valve are disclosed in U. S. Publication No. 2013 / 0030519, which is incorporated by reference herein.

[0098] Portions of the delivery apparatus 100 can be arranged with features configured to maintain the prosthetic valve 150 in a desired axial position (i.e., resisting axial movement). In some examples, as seen in FIG. 2B, the delivery apparatus 100 can optionally include aTHVMC-24095W001valve mounting member 168 positioned inside the balloon 118 along the valve mounting portion 124 to help maintain the position of the prosthetic valve 150 on the balloon 118.

[0099] Additionally (or alternatively), in some examples, when the prosthetic valve 150 is in position on the valve mounting portion 124, a distal end of the prosthetic valve 150 is positioned adjacent a distal end of the valve mounting portion 124, that is, adjacent the distal shoulder 126. As such, the distal shoulder 126 can be configured to resist movement of the prosthetic valve 150 relative to the balloon 118 distally in the axial direction, for example, when the balloon 118 is initially expanded. In some examples, as shown in FIGS. 2A-2B, the distal shoulder 126 can be positioned within the balloon 118, such that the balloon 118 expands in the radially outwards direction and away from the distal shoulder 126 as the balloon 118 expands in the radially outwards direction and deploys the prosthetic heart valve 150. The distal shoulder 126 can also protect and shield the leading edge (i.e., the distal edge) of the prosthetic valve 150 from contacting native anatomy as the delivery apparatus 100 is advanced through the subject’s vasculature.

[0100] In some examples, during delivery of the prosthetic valve 150, the outer shaft 104 can be positioned relative to the intermediate shaft 106 such that the distal tip portion 128 is positioned adjacent a proximal end of the valve mounting portion 124 and adjacent a proximal end of the prosthetic valve 150. In some examples, the distal end of the distal tip portion 128 can abut the proximal end of the prosthetic valve 150. As such, in some examples, the distal tip portion 128 is also referred to herein as a “proximal shoulder.” In this position, the outer shaft 104 is disposed around and covers a portion of the balloon 118. The proximal shoulder 128 can be configured to resist movement of the prosthetic valve 150 relative to the balloon 118 proximally in the axial direction, for example, as the delivery apparatus 100 and prosthetic valve 150 are advanced through the subject’s vasculature and / or an introducer sheath. In some examples, prior to expanding the balloon 118, the outer shaft 104 is retracted proximally relative to the intermediate shaft 106 to enable the balloon 118 to be fully inflated (for example, without interference with the outer shaft 104).

[0101] Also, as noted above, for the off-balloon delivery configuration of FIG. 2B, the distal tip portion 128 of the outer shaft 104 can be used to push the prosthetic valve 150 onto the valve mounting portion 124 once the prosthetic valve 150 and the distal end portion of the delivery apparatus 100 are inserted into the subject’s vasculature.THVMC-24095W001

[0102] While effective in resisting axial movement of the prosthetic valve 150, structures positioned inside of a balloon, such as the distal shoulder 126, can involve relatively complex manufacturing steps. For example, once the balloon 118 has been formed or shaped, it can be difficult to insert the distal shoulder 126 inside the balloon 118.

[0103] Moreover, when deploying the prosthetic valve 150, the prosthetic valve 150 desirably is positioned to be substantially coaxial with the annulus of the native heart valve so that the prosthetic valve 150 can be evenly expanded and securely anchored within the annulus. In some circumstances, despite the initial position of the prosthetic valve 150 being coaxial with the native annulus, such coaxiality may be disturbed or lost after retracting the outer shaft 104 off the balloon 118 just prior to balloon inflation. This can occur if the steerable section 164 of the outer shaft 104 is retained in a curved state via increased tension in the pull wire (for example, pull wire 166) while the outer shaft 104 is retracted. Retracting the outer shaft 104 retracts the steerable section 164 farther away from the balloon 118 and the prosthetic valve 150. Without the structural support of the steerable section 164, the distal end portion of the intermediate shaft 106 and the distal end portion of the inner shaft 108 (where the balloon 118 and the prosthetic valve 150 are mounted) may deflect slightly relative to the steerable section 164. As a result, the prosthetic valve 150 may no longer be coaxial with the native annulus.

[0104] Thus, in some examples, it may be desirable for retaining structures that help maintain the axial position of a prosthetic valve (for example, the prosthetic valve 10 or the prosthetic valve 150) relative to a delivery apparatus (for example, the delivery apparatus 100) to be disposed around or on the outside of a balloon (for example, the balloon 118) of the delivery apparatus. Retaining structures disposed around a balloon can facilitate insertion of the prosthetic valve through a subject’s vasculature and an introducer sheath and improve the positioning of the prosthetic valve relative to the balloon during delivery without requiring translation of an outer shaft (for example, outer shaft 104) prior to inflating the balloon, among other things.

[0105] For example, these retaining structures can be configured to expand as the balloon expands and, in some examples, these retaining structures can help maintain the position of the prosthetic valve relative to the delivery apparatus during radial expansion of the prosthetic valve. In some examples, these retaining structures can be used in lieu of a distalTHVMC-24095W001shoulder (for example, distal shoulder 126) and / or a proximal shoulder (for example, proximal shoulder 128). As introduced above and described in more detail below, these retaining structures can be advantageously joined to an outer surface of a balloon of the delivery apparatus.

[0106] FIG. 3 is a side view of an inflatable medical balloon (also referred to herein as a “catheter balloon,” a “balloon,” or a “medical balloon”) 200, according to an example, where the balloon 200 is shown in a radially expanded, inflated state. The balloon 200 (or any other balloon described herein) can be used with the delivery apparatus 100 in lieu of the balloon 118 to expand a prosthetic implant. The balloon 200 can be configured to be inflatable between a deflated state (also referred to herein as an “uninflated” state) and an inflated state about a central longitudinal axis 202.

[0107] The balloon 200 can comprise a proximal end 210, a distal end 212, and a wall 214 extending from the proximal end 210 to the distal end 212. The wall 214 comprises a central portion 218, proximal end portion 220, and a distal end portion 222 distally disposed relative to the proximal end portion 220. The central portion 218 can have a proximal end 224 and a distal end 226.

[0108] The proximal end portion 220 can comprise a proximal tapered portion 230 (which can also be referred to herein as a “proximal cone portion” or a “proximal tapered end portion”) and a proximal leg 232 extending proximally from the proximal tapered portion 230. The distal end portion 222 can comprise a distal tapered portion 236 (which can also be referred to herein as a “distal cone portion” or a “distal tapered end portion”) and a distal leg 238 extending distally from the distal tapered portion 236.

[0109] The proximal leg 232 can be configured to be coupled to a shaft of a delivery apparatus (for example, the intermediate shaft 106 in FIG. 2A) and the distal leg 238 can be configured to be coupled to a distal end component (for example, the nose cone 122 in FIG.2A and / or the inner shaft 108). The central portion 218, in some examples, can coincide with a working portion of the balloon 200 and can be configured to receive a prosthetic implant (for example, the prosthetic heart valves 10, 150, or any other prosthetic implant described herein) in a radially compressed state. In some examples, the proximal leg 232, the distal leg 238, the proximal tapered portion 230, the central portion 218, and the distal tapered portionTHVMC-24095W001236 can be integrally formed as a single component along with a retaining structure (also referred to herein as an “outer structure” or an “implant retaining structure”) 240, in some examples, which will be described in more detail below.

[0110] Each one of the proximal tapered portion 230, the central portion 218, and the distal tapered portion 236 can define a maximum diameter in a radial direction. As shown in FIG.3, in some examples, the maximum diameters of the proximal tapered portion 230, the central portion 218, and the distal tapered portion 236 are equal, such that the diameters of the proximal and distal tapered portions 230 and 236 taper from the proximal and distal ends 224, 226 of the central portion 218 towards their respective ends of the catheter balloon 200.

[0111] In some examples, the maximum diameters of the proximal tapered portion 230, the central portion 218, and / or the distal tapered portion 236 can be equal or at least substantially equal (for example, within 10%). As shown in FIG. 3, the proximal tapered portion 230 and the distal tapered portion 236 can each have a conical or frustoconical shape when the balloon 200 is inflated. In some examples, the proximal tapered portion 230 and the distal tapered portion 236 can have a hemispherical, a semi -ellipsoid shape, or a bulbous shape when the balloon is inflated. In some examples, the central portion 218 can have a cylindrical shape when inflated, as shown in FIG. 3. In some examples, the central portion 218 can have a rounded, bulbous configuration and bow out when inflated, thus defining the maximum diameter in the radial direction.

[0112] The wall 214 of the balloon 200 can further define an outer surface 250. The outer surface 250 can be a radially outwards-facing surface of the balloon 200 with different sections. For example, the outer surface 250 of the balloon wall 214 can be divided into a proximal section 252 (which is also referred to herein as a “proximal outer surface” and / or a “proximal outer surface section”), a central section 254 (which is also referred to herein as an “central outer surface” and / or an “central outer surface section”), and a distal section 256 (which is also referred to herein as a “distal outer surface” and / or a “distal outer surface section”). The proximal section 252 of the outer surface 250 can be the outer surface of the proximal tapered portion 230. The central section 254 of the outer surface 250 can be the outer surface of the central portion 218. The distal section 256 of the outer surface 250 can be the outer surface of the distal tapered portion 236.THVMC-24095W001

[0113] The wall 214 of the balloon 200 (or any other balloon described herein) can be made of a polymeric material, such as for example, a polyamide (PA) or co-polyamide, such as nylon (for example nylon 12), Pebax®, a polyester, such as polyethylene terephthalate (PET), polybutylene terephthalate, a thermoplastic elastomer copolyester (such as Hytrel®), or combinations thereof.

[0114] As described above, in some examples, the balloon 200 can be inflated into an expanded or a partially expanded state by pushing an inflation fluid from a fluid source into the balloon 200. In some instances, the balloon 200 can be inflated to deploy a prosthetic implant. In some instances, the balloon 200 can be inflated or partially inflated as part of a de-airing process. The inflation fluid can be withdrawn from the balloon 200 to deflate the balloon 200 into a collapsed or uninflated configuration.

[0115] As introduced above, the balloon 200 can comprise a polymeric retaining structure 240 that is joined or fixed to the outer surface 250 of the wall 214 of the balloon 200. The retaining structure 240 can be configured to radially protrude from the outer surface 250 as shown in FIGS. 3-3D. The retaining structure 240 can comprise a plurality of intersecting stmts disposed on at least one of the proximal and distal tapered portions 230, 236. In some examples, intersecting stmts 260 can be disposed on both the proximal and distal tapered portions 230, 236 of the balloon 200, as shown in FIG. 3.

[0116] The intersecting stmts 260 can be oriented at non-zero angles with respect to the longitudinal axis 202 of the balloon 200, thus forming a lattice or frame configuration comprising a plurality of rows of cells that can expand as the balloon 200 expands or inflates. The intersecting stmts 260 can be referred to as “angled stmts.” For example, intersecting stmts 260p can be arranged on the proximal tapered portion 230 to form a first row 262a of cells 264a and a second row 262b of cells 264b that together form a proximal lattice having a proximal end 268a and a distal end 268b. Intersecting stmts 260p in the first row 262a can connect at apices 270a at the proximal end 268a of the proximal lattice and intersecting stmts 260p in the second row 262b can connect at apices 270b at the distal end 268b of the proximal lattice. Cells 264a can form intersections or junctions 266a with adjacent cells 264a in the first row 262a and cells 264b can form intersections or junctions 266b with adjacent cells 264b in the second row 262b. In some examples, the cells 264a and 264b are diamondshaped cells.THVMC-24095W001

[0117] Similarly, in some examples, intersecting struts 260d can be arranged on the distal tapered portion 236 to form a first row 262c of cells 264c and a second row 262d of cells 264d that together form a distal lattice having a proximal end 268d and distal end 268c. Intersecting struts 260d in the first row 262c can connect at apices 270c at the distal end 268c of the distal lattice and intersecting struts 260d in the second row 262d can connect at apices 27 Od at the proximal end 268d of the distal lattice. Cells 264c can form intersections or junctions 266c with adjacent cells 264c in the first row 262c and cells 264d can form intersections or junctions 266d with adjacent cells 264d in the second row 262d. In some examples, the cells 264c are diamond-shaped cells.

[0118] Although the example shown in FIG. 3 shows the cells 264a, 264b, 264c as diamondshaped cells, struts forming the proximal and distal lattices can be arranged to form other shaped cells, for example, chevron, trapezoidal, or triangular shaped cells.

[0119] Although FIG. 3 shows the intersecting struts 260p, 260d forming an expandable cell arrangement or lattice with two rows of cells on each the proximal and distal tapered portions 230, 236 of the wall 214, it is understood that the intersecting struts 260p, 260d can be arranged to form any number of rows with any number of cells.

[0120] In the illustrated example, the junctions 266d between adjacent cells 264d are in the form of side stmts 272. Thus, each cell 264d is bounded by two angled stmts 260d at its distal end, two angled stmts 260d at its proximal end, and two side stmts 272 that extend substantially along a direction of the longitudinal axis 202 of the balloon 200. In some examples, each side stmt 272 can include a plurality of undulations such that each stmt 272 can have a zig-zag shape or a sinusoidal shape. In some examples, the stmts 272 can expand in length in a direction parallel to the longitudinal axis 202 when the balloon is inflated.

[0121] In some examples, any of the intersections 266a-266d can comprise a side stmt 272. In some examples, the stmts 272 can be formed on either or both the proximal and distal tapered portions 230, 236 (e.g., any of cells 264a, 264b, 264c, or 264d can include stmts 272). In some examples, intersections 266a-266d in the same row of cells can have undulating stmts 272 alternating with linear (i.e., non-undulating), longitudinally extending stmts of the same length as the adjacent stmts 272.THVMC-24095W001

[0122] The intersecting struts 260 can be configured to protrude radially outward from the wall 214 of the balloon 200, where the wall 214 has a uniform (within 5%) or at least substantially uniform thickness tl from the proximal end 210 to the distal end 212. As seen in FIG. 3A, the intersecting stmts 260p, 260d can protrude radially outward from the proximal and distal sections 252, 256, respectively, of the outer surface 250 and have a radial thickness t2, where the radial thickness t2 is defined as a radial distance extending from the outer surface 250 of the wall 214 to an outer, radial surface 274 of the stmts 260p, 260d.

[0123] In some examples, the radial thickness t2 of the stmts 260p, 260d can be 0.020 - 0.100 inches.

[0124] In some examples, the radial thickness t2 of the stmts 260p, 260d can be 0.040 - 0.060 inches.

[0125] In some examples, the radial thickness t2 of the stmts 260p, 260d can be at least 1.5 times the radial thickness tl of the wall 214 of the balloon.

[0126] In some examples, the radial thickness t2 of each stmt 260p, 260d can be the same or substantially the same (i.e., within 5%) as the other stmts. In some examples, the radial thickness t2 of each stmt 260p, 260d can vary from stmt to stmt.

[0127] The intersecting stmts 260p, 260d can be configured with a width wl extending from a first side wall 276 to a second side wall 278, where in some examples, the width wl can be 0.040 - 0.150 inches.

[0128] In some examples, the width wl can be 0.060-0.100 inches.

[0129] In some examples, the width wl can be approximately the same (i.e., within 5%) as the radial thickness t2.

[0130] In some examples, the width wl can be at least 1.5 times the radial thickness t2.

[0131] In some examples, the width wl of each stmt 260p, 260d can be the same or substantially the same (i.e., within 5%) as the other stmts 260p, 260d. In some examples, the width wl of each stmt 260p, 260d can vary from stmt to stmt. In some examples, to facilitate release from a mold as will be described in more detail below, the width wl of the stmts 260p, 260d can have a draft angle (e.g., 1-3%) in which the width wl is larger whereTHVMC-24095W001the struts 260p, 260d meet the outer surface 250. In other words, the first and second side walls 276, 278 can be non-perpendicular or slanted with respect to the outer surface 250.

[0132] As seen in FIGS. 3 and 4, the retaining structure 240 can further comprise at least one shoulder 280 radially protruding from the wall 214 at or adjacent the proximal and / or distal ends 224, 226 of the central portion 218. In some examples, the retaining structure 240 can comprise only one shoulder 280, disposed at or adjacent either the proximal end 224 or the distal end 226 of the central portion 218. In the illustrated example, the retaining structure 240 comprises a circumferentially extending row of shoulders 280 at the proximal end 224 of the central portion 218 and a circumferentially extending row of shoulders at the distal end 226 of the central portion 218. In some examples, the retaining structure 240 can comprise a single circumferentially extending row of shoulders 280, such as at the distal end 226 of the central portion 218 or at the proximal end 224 of the central portion 218.

[0133] In some examples, the retaining structure 240 can comprise a plurality of shoulders in which the shoulders 280 in a row are spaced apart from one another in a circumferential direction around the balloon 200. In some examples, the shoulders 280 in a row can be evenly spaced from one another in the circumferential direction. For example, the shoulders 280 can be arranged on the wall 214 in connection with adjacent intersecting struts 260p, 260d at intersections 282, thus forming a continuous structure between the intersecting struts 260 and the shoulders 280. In other words, the shoulders 280 can be disposed on apices 270b at the distal end 268b of the proximal tapered portion 230 and / or disposed on apices 270d at the proximal end 268d of the distal tapered portion 236. In some examples, the shoulders 280 can be variably spaced from one another in the circumferential direction at selected apices 270b, 270d at the distal or proximal ends 268b 268d.

[0134] As will be described in more detail below in connection with FIGS. 3C and 3D, the at least one shoulder 280 can be configured with a greater radial thickness than an adjacent surface of the central portion 218 of the balloon 200, where the radial thickness is defined as the radial distance between the adjacent surface and an outer, radial tip 284 of the shoulder 280. This increased radial thickness can, in some examples, maintain a prosthetic implant (such as, for example, the prosthetic valves 10, 150, or any other prosthetic implant described herein) in a desired axial position on the balloon 200.THVMC-24095W001

[0135] In some examples, the retaining structure 240 can optionally comprise a plurality of longitudinal ribs protruding radially outward from the central portion 218 of the wall 214. The longitudinal ribs 290 can extend along the direction of the longitudinal axis 202 of the balloon 200. Each longitudinal rib 290 can have a proximal end 291 and a distal end 293. In some examples, the proximal ends 291 can be located at or adjacent the proximal end 224 of the central portion 218 of the wall 214 and the distal ends 293 can be located at or adjacent the distal end 226 of the central portion 218 of the wall 214. In this way, the proximal end 291 of each longitudinal rib 290 can connect to adjacent intersecting stmts 260p at the proximal end 224 of the central portion 218 of the wall 214, and the distal end 293 of each longitudinal rib 290 can connect to adjacent intersecting stmts 260d at the distal end 226 of the central portion 218 of the wall 214. Stated differently, each rib 290 can extend from an apex 270b of the proximal lattice to an apex 270d of the distal lattice.

[0136] The longitudinal ribs 290 can be spaced apart from one another in the circumferential direction around the balloon. In some examples, the longitudinal ribs 290 can be evenly spaced from one another in the circumferential direction. For example, the longitudinal ribs 290 can be arranged on the wall 214 in connection with adjacent intersecting stmts 260p, 260d, thus forming a continuous structure between the intersecting stmts 260 and the longitudinal ribs 290. In other words, the longitudinal ribs 290 can be arranged to extend from the apices 270b at the distal end 268b of the proximal tapered portion 230 to apices 270d at the proximal end 268d of the distal tapered portion 236. In some examples, the longitudinal ribs 290 can be variably spaced from one another in the circumferential direction, extending only between select, opposing apices 270b, 270d.

[0137] Like the intersecting stmts 260, the longitudinal ribs 290 can be configured to protrude radially outward from the wall 214 of the balloon 200. As seen in FIG. 3B, the longitudinal ribs 290 can protmde radially outward from the central section 254 of the outer surface 250 a radial thickness t3, where the radial thickness t3 is defined as the radial distance from the outer surface 250 of the wall 214 to an outer, radial surface 294 of the longitudinal ribs 290. In some examples, the radial thickness t3 of the longitudinal ribs 290 can be 0.020 -0.100 inches.

[0138] In some examples, the radial thickness t3 of the longitudinal ribs 290 can be 0.040 -0.060 inches.THVMC-24095W001

[0139] In some examples, the radial thickness t3 of the longitudinal ribs 290 can be at least 1.5 times the radial thickness tl of the wall 214 of the balloon.

[0140] In some examples, the radial thickness t3 of each of the longitudinal ribs 290 can be the same or substantially the same (i.e., within 5%) as the other ribs. In some examples, the radial thickness t3 of each longitudinal rib 290 can vary from rib to rib. In some examples, the radial thickness t3 of each longitudinal rib 290 can vary from the proximal to distal ends 291, 293. For example, the radial thickness t3 can be shorter at a center of the longitudinal rib 290 than at either the proximal or distal ends 291, 293, or vice-versa.

[0141] In some examples, the thicknesses t2 and t3 can be the same. In some examples, the thickness t2 can be greater than the thickness t3. In some examples, the thickness t3 can be greater than the thickness t2.

[0142] The longitudinal ribs 290 can be configured with a width w2 extending from a first side wall 296 to a second side wall 298, where in some examples, the width w2 can be 0.040 - 0.150 inches.

[0143] In some examples, the width w2 can be 0.060-0.100 inches.

[0144] In some examples, the width w2 can be approximately the same (i.e., within 5%) as the radial thickness t3.

[0145] In some examples, the width w2 can be at least 1.5 times the radial thickness t3.

[0146] In some examples, the width w2 of the longitudinal ribs 290 can be the same or substantially the same (i.e., within 5%) as the other ribs. In some examples, the width w2 of each longitudinal rib 290 can vary from rib to rib. In some examples, to facilitate release from a mold as will be described in more detail below, the width w2 of the longitudinal ribs 290 can have a draft angle (e.g., 1-3%) in which the width w2 is larger where the longitudinal ribs 290 meet the outer surface 250. In other words, the first and second side walls 296, 298 can be non-perpendicular or slanted with respect to the outer surface 250. In some examples, the widths wl and w2 can be the same. In some examples, the width wl can be greater than the width w2. In some examples, the width w2 can be greater than the width w 1.

[0147] In some examples, as shown in FIG. 3C, the at least one shoulder 280 can be integrated into a longitudinal rib 290. In other words, at least one longitudinal rib 290 can beTHVMC-24095W001configured with an increased radial thickness t4 at its proximal and / or distal end 291, 293 to form the at least one shoulder 280, where the radial thickness t4 is defined as the radial distance from the adjacent outer, radial surface 294 of the longitudinal rib 290 to the outer tip 284 of the shoulder 280. Each shoulder 280 can have an overall radial thickness (measured from the outer surface of the wall 214 to the tip 284) of t4 plus t3.

[0148] In examples in which the retaining structure 240 comprises a plurality of shoulders at the proximal end 224 and / or the distal end 226 of the central portion 218, respective proximal and / or distal ends 291, 293 of longitudinal ribs 290 can be configured with the increased radial thickness t4 to form the plurality of shoulders.

[0149] In an alternate example in which the retaining structure 240 comprises at least one shoulder 280 at the proximal end 224 and / or the distal end 226 of the central portion 218 without any longitudinal ribs 290, a radial thickness t5 of the at least one shoulder 280 can be defined as a radial distance from an adjacent portion of the central section 254 of the outer surface 250 of the wall 214 to the outer tip 284 of the shoulder 280 as seen in FIG. 3D.

[0150] In some examples, the radial thickness t4, t5 can be 0.100-0.250 inches, for example, or a sufficient thickness to retain a prosthetic implant on the balloon and prevent axial movement of the prosthetic implant relative to the balloon. Stated another way, the radial thickness t4, t5 can be specified to be greater than a radial thickness of a prosthetic implant mounted thereon (for example, a radial thickness from an inside surface to an outside surface of a frame, such as the frame 12 of the prosthetic valve 10 in FIG. 1, or the like).

[0151] In some examples, the at least one shoulder 280 can have a radial thickness t4, t5 that is greater than a radial thickness t2 of the plurality of intersecting struts and / or a radial thickness 13 of the plurality of longitudinal ribs. In some examples, 14 can be the same as t5.

[0152] The retaining structure 240 can be formed as a single component comprising a collection of connected intersecting stints 260, one or more shoulders 280, and in some examples, longitudinal ribs 290. The retaining structure 240 (e.g., the component comprising the collection of the struts 260, shoulders 280, and longitudinal ribs 290) can be made of a polymeric material, such as for example, a polyamide (PA) or co-polyamide, such as nylon (for example nylon 12), Pebax®, a polyester, such as polyethylene terephthalate (PET), polybutylene terephthalate, a thermoplastic elastomer copolyester (such as Hytrel®), orTHVMC-24095W001combinations thereof. In some examples, the retaining structure 240 can be made of any polymeric material capable of being fused or welded to the material of the wall 214 of the balloon 200. In some examples, the retaining structure is made of the same polymer as the wall 214 of the balloon 200.

[0153] In some examples, the polymeric retaining structure 240 can be molded directly into the wall 214 of the balloon 200, thus forming the retaining structure 240 and the wall 214 as a unitary structure as shown in FIGS. 3A-3D. For example, the retaining structure 240 can be integrally formed with (i.e., integrated into) the wall 214 during a molding procedure in which features of the retaining structure 240 are formed by corresponding features of the mold. For example, when a parison is expanded inside a mold during a blow molding procedure, the parison can conform to internal mold features including features or voids defining the retaining structure 240. In this way, the wall 214 of the balloon 200 and the retaining structure 240 can be formed at the same time as the parison expands into and around the features and voids in the mold forming the retaining structure 240.

[0154] In another example, liquid polymer can be injected into a mold during an injection molding procedure, with the liquid polymer conforming to internal mold features, including features or voids defining the retaining structure 240. Thus, both the wall 214 of the balloon 200 and the retaining structure 240 can be formed at the same time as a unitary structure in which the retaining structure 240 is integrally formed with or integrated into the wall 214.

[0155] Alternatively, in some examples, the polymeric retaining structure 240 can be formed separately from the balloon wall 214 and fused to the outer surface 250 of the wall 214 along a fused interface 300 as shown in FIGS. 3A-3D, where the fused interface 300 is defined as a boundary where the polymeric retaining structure 240 and the outer surface 250 meet. In some examples, the polymeric retaining structure 240 can be fused to the balloon wall 214 using any conventional polymeric joining process such as, for example, welding (e.g., heat welding) or bonding using a chemical or an adhesive.

[0156] In some examples, the polymeric retaining structure 240 can be formed separately and inserted into a mold in which the balloon 200 is fabricated in an insert or over molding procedure. For example, after separately forming the polymeric retaining structure 240 (e.g., in an injection molding process), the retaining structure 240 can be inserted into a mold forTHVMC-24095W001forming the balloon 200. A parison can be positioned inside the mold containing the polymeric retaining structure 240 and then expanded in a blow molding procedure. The parison is expanded into contact with the retaining structure 240 and forms the wall 214 of the balloon 200. The heat and pressure of the blow molding process can cause the parison to become fused to the retaining structure 240.

[0157] In use, the balloon 200 of FIGS. 3-4 can be secured to a distal end portion of a delivery device. For example, FIG. 5 illustrates a distal end portion of the delivery apparatus 100 of FIG. 2A comprising the balloon 200 of FIGS. 3-4 in lieu of the balloon 118 and the prosthetic valve 10 of FIG. 1 in place of the prosthetic valve 150. The distal end portion 222 of the balloon 200 can be coupled to the distal end portion of the delivery apparatus 100, such as to the nose cone 122 (as shown in FIG. 5), or to an alternate component (for example, a distal shoulder). The proximal end portion 220 of the balloon 200 can be coupled to a distal end portion of the intermediate shaft 106.

[0158] The central portion 218 of the balloon 200 and the inner shaft 108 can form or define the valve mounting portion 124 onto which the prosthetic valve 10 is mounted as shown. The shoulders 280 of the balloon 200 shown in FIG. 5 are configured to flank the inflow and outflow end portions 15, 19 of the prosthetic valve 10, thus capturing the valve 10 in an axial position on the balloon 200. In other words, because the radial thickness t4 of the shoulders 280 is at least equal to or greater than an outer radius of the prosthetic valve 10 as shown in FIG. 5, the shoulders 280 disposed on either end of the valve 10 constrain the prosthetic valve 10 in an axial position on the delivery apparatus 100. The shoulders 280 prevent axial movement of the prosthetic valve 10 as the prosthetic valve 10 is, for example, inserted through an introducer sheath and the vasculature of the subject and during inflation of the balloon to deploy (radially expand) the prosthetic valve 10.

[0159] In an alternative example, the retaining structure 240 can be configured for use with a prosthetic implant in an off-balloon configuration, for example, as shown in FIG. 2B. For such an off-balloon delivery, the retaining structure 240 can comprise at least one shoulder 280 at only the distal end 226 of the central portion 218. In some examples, the at least one shoulder 280 can comprise a circumferentially extending row of shoulders 280 at only the distal end 226 of the central portion 218. As discussed above, for off-balloon delivery, the prosthetic implant (such as, for example, prosthetic valves 10 or 150 or any other prostheticTHVMC-24095W001implant described herein) can be radially crimped in an axially offset position as described above in connection with FIG. 2B. A distal end of an outer shaft (such as the distal tip portion 128 of the outer shaft 104, for example) can abut the proximal end of the prosthetic implant to prevent proximal movement of the prosthetic implant relative to the balloon 200 in lieu of proximal shoulders 280 during delivery of the implant through the subject’s vasculature.

[0160] After the prosthetic valve 10 is radially expanded, the balloon 200 can be deflated and removed from the subject’s body. In some examples, the retaining structure 240 is resiliently expandable such that it can collapse radially under its own resiliency when the balloon is deflated. In this manner, the resiliency of the retaining structure 240 can assist in collapsing the balloon when the inflation fluid is removed from the balloon.

[0161] Another advantage of the retaining structure 240 is that it can reduce the overall length of the balloon compared to a conventional balloon without a retaining structure. For example, known delivery apparatuses used for delivering balloon-expandable prosthetic heart valves typically include balloons with relatively long distal and proximal sections that extend beyond the distal and proximal ends of the prosthetic valve. These distal and proximal balloon sections typically are inflated at a faster rate than the central section of the balloon on which the prosthetic valve is mounted. As a result, the balloon can assume a “dog bone" shape as it is being inflated such that the distal and proximal sections can be inflated to a greater diameter than the prosthetic valve, at least initially. This is advantageous in that the distal and proximal balloon sections help fix the position of the prosthetic valve on the balloon and minimize shifting of the prosthetic valve relative to the balloon as the balloon is inflated to deploy the prosthetic valve. However, the relatively long balloon can make navigating a subject’s vasculature more difficult and may contact portions of the subject’s vasculature (for example, the sinotubular junction (STJ) and / or the left ventricular outflow tract (LVOT)) during a prosthetic valve implantation procedure. By incorporating the shoulders 280 into the retaining structure 240 for retaining the prosthetic valve on the balloon during deployment, the overall length of the balloon can be substantially reduced, which facilitates navigation of the delivery apparatus through the subject’s vasculature. The shorter axial length of the balloon also can help minimize the risk of balloon rupture and conduction disturbances at the LVOT.THVMC-24095W001

[0162] Another advantage of the retaining structure 240 is that it can prevent or minimize the propagation of a tear in the balloon in the event that the balloon ruptures, such as from inadvertent overinflation. In particular, the struts 260 and / or the ribs 290 reinforce the wall of the balloon at those locations and can prevent a tear from propagating across the struts and ribs in an axial and / or circumferential direction.

[0163] Although the balloon 200 is shown in FIG. 5 in connection with the delivery apparatus 100 and the prosthetic valve 10, it is understood that the balloon 200 can be used with any delivery apparatus and / or prosthetic implant disclosed herein.Delivery Techniques

[0164] 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 (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). Additionally and / or 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 aorticvalve. Additionally and / or 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.

[0165] 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 theTHVMC-24095W001inferior 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 Additionally and / or 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.

[0166] 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.

[0167] 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 trans ventricular 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.

[0168] 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.SterilizationTHVMC-24095W001

[0169] 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 subjects such as human 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 usable and / or for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals usable and / or 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.Simulation

[0170] Any of the above method(s) and any methods of using the systems, assemblies, apparatuses, devices, etc. herein can be performed on a living subject (e.g., human or other animal) or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, imaginary person, simulator (e.g., with the body parts, tissue, etc. being simulated), etc. With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can optionally comprise computerized and / or physical representations.Additional Examples of the Disclosed Technology

[0171] 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.

[0172] Example 1. An inflatable medical balloon comprising: a wall extending from a distal end to a proximal end of the balloon, wherein the wall comprises a proximal end portion, a distal end portion, and a central portion extending from the proximal end portion to the distal end portion; and a polymeric retaining structure fixed to an outer surface of the wall of the balloon, wherein the retaining structure comprises: a plurality of intersecting struts protruding radially outward from the proximal end portion, the distal end portion, or both the proximalTHVMC-24095W001and distal end portions of the wall; and a plurality of shoulders disposed adjacent a proximal end of the central portion of the wall, a distal end of the central portion of the wall, or both the proximal and distal ends of the central portion of the wall, wherein each shoulder of the plurality of shoulders protrudes radially outward from the outer surface of the wall.

[0173] Example 2. The balloon of any example herein, particularly example 1, wherein the retaining structure further comprises a plurality of longitudinal ribs protruding radially outward from the central portion of the wall and extending along a direction of a longitudinal axis of the balloon, wherein the longitudinal ribs of the plurality of longitudinal ribs are spaced apart from one another in a circumferential direction around the balloon.

[0174] Example 3. The balloon of any example herein, particularly example 2, wherein the intersecting struts of the plurality of intersecting struts protrude radially outward from both the proximal and distal end portions of the wall and the plurality of longitudinal ribs are connected to the plurality of intersecting stmts at the distal and proximal ends of the central portion of the wall.

[0175] Example 4. The balloon of any example herein, particularly example 3, wherein each longitudinal rib of the plurality of longitudinal ribs has a distal end and a proximal end, and wherein the shoulders of the plurality of shoulders protrude radially outward from the distal and proximal ends of at least one of the plurality of longitudinal ribs.

[0176] Example 5. The balloon of any example herein, particularly example 4, wherein the shoulders of the plurality of shoulders protrude radially outward from the distal and proximal ends of each longitudinal rib of the plurality of longitudinal ribs.

[0177] Example 6. The balloon of any example herein, particularly any one of examples 1-5, wherein the intersecting struts of the plurality of intersecting struts are joined by one or more zig-zag shaped struts.

[0178] Example 7. The balloon of any example herein, particularly any one of examples 1-6, wherein the wall and the retaining structure comprise and / or are formed from the same polymer.

[0179] Example 8. The balloon of any example herein, particularly any one of examples 1-7, wherein the retaining structure is integrally formed with the wall.THVMC-24095W001

[0180] Example 9. The balloon of any example herein, particularly any one of examples 1-8, wherein the proximal end portion and the distal end portion of the wall each have tapered portions.

[0181] Example 10. A delivery apparatus for a prosthetic implant, the delivery apparatus comprising: a shaft; and an inflatable medical balloon having a distal end and a proximal end, wherein the balloon is coupled to a distal end portion of the shaft and comprises: a wall extending from the distal end of the balloon to the proximal end of the balloon, wherein the wall comprises a proximal end portion, a distal end portion, and a central portion extending from the proximal end portion to the distal end portion; and a polymeric outer structure integrated directly into the wall of the balloon, wherein the outer structure comprises intersecting struts protruding radially outward from the proximal end portion, the distal end portion, or both the proximal and distal end portions of the wall.

[0182] Example 11. The delivery apparatus of any example herein, particularly example 10, wherein the outer structure further comprises at least one shoulder protruding radially outward from a distal end of the central portion of the wall and at least one shoulder protruding radially outward from a proximal end of the central portion of the wall.

[0183] Example 12. The delivery apparatus of any example herein, particularly example 11, wherein the outer structure further comprises longitudinal ribs protruding radially outward from the central portion of the wall, wherein the longitudinal ribs extend along a direction of a longitudinal axis of the balloon and are spaced apart from one another in a circumferential direction around the balloon.

[0184] Example 13. The delivery apparatus of any example herein, particularly example 12, wherein the intersecting struts protrude radially outward from both the proximal and distal end portions of the wall and proximal and distal ends of each of the longitudinal ribs are connected to the intersecting struts.

[0185] Example 14. The delivery apparatus of any example herein, particularly example 13, wherein the at least one shoulder comprises a plurality of shoulders protruding radially outward from the distal and proximal ends of at least one of the longitudinal ribs.THVMC-24095W001

[0186] Example 15. The balloon of any example herein, particularly any one of examples 12-14, wherein the at least one shoulder has a greater radial thickness than a radial thickness of the longitudinal ribs.

[0187] Example 16. The delivery apparatus of any example herein, particularly any one of examples 10-15, wherein the outer structure is integrally molded with the wall of the balloon.

[0188] Example 17. The delivery apparatus of any example herein, particularly any one of examples 10-15, wherein the outer structure is fused with the wall of the balloon.

[0189] Example 18. The delivery apparatus of any example herein, particularly any one of examples 10-17, wherein the wall and the outer structure comprise nylon.

[0190] Example 19. A delivery apparatus for delivering a prosthetic implant through vasculature of a subject, the delivery apparatus comprising: a shaft; and an inflatable medical balloon having a distal end and a proximal end, wherein the balloon is coupled to a distal end portion of the shaft and comprises: a wall extending from the distal end of the balloon to the proximal end of the balloon; and an implant retaining structure joined to an outer surface of the wall of the balloon, wherein the implant retaining structure is configured to secure the prosthetic implant on the balloon and comprises: a plurality of intersecting struts protruding radially outward from a distal end portion of the wall and a proximal end portion of the wall; and at least one shoulder protruding radially outward from the wall.

[0191] Example 20. The delivery apparatus of any example herein, particularly example 19, wherein the implant retaining structure is configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0192] Example 21. The delivery apparatus of any example herein, particularly any one of examples 19-20, wherein the implant retaining structure further comprises a plurality of longitudinal ribs protruding radially outward from the wall and extending along a direction of a longitudinal axis of the balloon, wherein the longitudinal ribs of the plurality of longitudinal ribs are spaced around a circumference of the balloon.THVMC-24095W001

[0193] Example 22. The delivery apparatus of any example herein, particularly example 21, wherein each longitudinal rib of the plurality of longitudinal ribs has a distal end and a proximal end connected to the plurality of intersecting struts at an intersection.

[0194] Example 23. The delivery apparatus of any example herein, particularly example 22, wherein the at least one shoulder comprises a plurality of shoulders and each shoulder of the plurality of shoulders is disposed adjacent an intersection.

[0195] Example 24. The delivery apparatus of any example herein, particularly any one of examples 19-23, wherein the at least one shoulder has a radial thickness that is greater than a radial thickness of the plurality of intersecting struts and a radial thickness of the plurality of longitudinal ribs.

[0196] Example 25. The delivery apparatus of any example herein, particularly any one of examples 20-24, wherein the wall and the implant retaining structure comprise nylon.

[0197] Example 26. The delivery apparatus of any example herein, particularly any one of examples 19-25, wherein the prosthetic implant is a prosthetic valve and the at least one shoulder is configured to retain the prosthetic valve in an axial position on the balloon.

[0198] Example 27. A method of forming a medical balloon comprising: forming a wall of the balloon from a polymer; and forming a retaining structure from a polymer, wherein the retaining structure comprises a plurality of intersecting struts and a plurality of shoulders, and wherein the retaining structure is joined to an outer surface of the wall and protrudes radially outward therefrom.

[0199] Example 28. The method of any example herein, particularly example 27, further comprising molding the retaining structure as part of the wall of the balloon.

[0200] Example 29. The method of any example herein, particularly example 27, further comprising fusing the retaining structure with the wall of the balloon using heat welding or bonding.

[0201] Example 30. The method of any example herein, particularly example 27, further comprising insert-molding the retaining structure into the wall of the balloon.

[0202] Example 31. A method comprising sterilizing the prosthetic heart valve, inflatable medical balloon, apparatus, and / or assembly of any example.THVMC-24095W001

[0203] Example 32. An inflatable medical balloon of any one of examples 1-31, wherein the inflatable medical balloon is sterilized.

[0204] Example 33. The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, or simulator (e.g., with body parts, heart, tissue, etc. being simulated).

[0205] Thus, specific examples of delivery apparatuses and related methods have been disclosed. The above description of the disclosed implementations is provided to enable any person skilled in the art to make or use the delivery apparatuses. The preceding detailed description is merely exemplary in nature and is not intended to limit the delivery apparatuses or the application and uses of the delivery apparatuses. 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. Various modifications to these implementations will be readily apparent to those skilled in the art, and the general principles described herein can be applied to other implementations without departing from the spirit or scope of the application. Thus, it is to be understood that the description and drawings presented herein represent an implementation of the delivery apparatuses and are therefore representative of the subject matter which is broadly contemplated by the present application. It is further understood that the scope of the present application fully encompasses other implementations that may become obvious to those skilled in the art and that the scope of the present application is accordingly not limited.

[0206] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one balloon can be combined with any one or more features of another balloon. As another example, any one or more features of retaining structure can be combined with any one or more features of another retaining structure.

[0207] 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.THVMC-24095W001

[0208] All structural and functional equivalents to the components of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

Claims

THVMC-24095W001CLAIMS:

1. An inflatable medical balloon comprising:a wall extending from a distal end of the balloon to a proximal end of the balloon, wherein the wall comprises a proximal end portion, a distal end portion, and a central portion extending from the proximal end portion to the distal end portion: anda polymeric retaining structure fixed to an outer surface of the wall of the balloon, wherein the polymeric retaining structure comprises:a plurality of intersecting struts protruding radially outward from the proximal end portion, the distal end portion, or both the proximal and distal end portions of the wall; anda plurality of shoulders disposed adjacent a proximal end of the central portion of the wall, a distal end of the central portion of the wall, or both the proximal and distal ends of the central portion of the wall, wherein each shoulder of the plurality of shoulders protrudes radially outward from the outer surface of the wall.

2. The balloon of claim 1, wherein the polymeric retaining structure further comprises a plurality of longitudinal ribs protruding radially outward from the central portion of the wall and extending along a direction of a longitudinal axis of the balloon, wherein the longitudinal ribs of the plurality of longitudinal ribs are spaced apart from one another in a circumferential direction around the balloon.

3. The balloon of claim 2, wherein the intersecting struts of the plurality of intersecting struts protrude radially outward from both the proximal and distal end portions of the wall and the plurality of longitudinal ribs are connected to the plurality of intersecting struts at the distal and proximal ends of the central portion of the wall.

4. The balloon of claim 3, wherein each longitudinal rib of the plurality of longitudinal ribs has a distal end and a proximal end, and wherein the shoulders of the plurality of shoulders protrude radially outward from the distal and proximal ends of at least one of the plurality of longitudinal ribs.THVMC-24095W0015. The balloon of claim 4, wherein the shoulders of the plurality of shoulders protrude radially outward from the distal and proximal ends of each longitudinal rib of the plurality of longitudinal ribs.

6. The balloon of any one of claims 1-5, wherein the intersecting struts of the plurality of intersecting struts are joined by one or more zig-zag shaped struts.

7. The balloon of any one of claims 1-6, wherein the wall and the polymeric retaining structure comprise and / or are formed from the same polymer.

8. The balloon of any one of claims 1-7, wherein the polymeric retaining structure is integrally formed with the wall.

9. A delivery apparatus for a prosthetic implant, the delivery apparatus comprising:a shaft: andan inflatable medical balloon having a distal end and a proximal end, wherein the balloon is coupled to a distal end portion of the shaft and comprises:a wall extending from the distal end of the balloon to the proximal end of the balloon, wherein the wall comprises a proximal end portion, a distal end portion, and a central portion extending from the proximal end portion to the distal end portion; anda polymeric outer structure integrated directly into the wall of the balloon, wherein the polymeric outer structure comprises intersecting struts protruding radially outward from the proximal end portion, the distal end portion, or both the proximal and distal end portions of the wall.

10. The delivery apparatus of claim 9, wherein the polymeric outer structure further comprises at least one shoulder protruding radially outward from a distal end of the central portion of the wall and at least one shoulder protruding radially outward from a proximal end of the central portion of the wall.THVMC-24095W00111. The delivery apparatus of claim 10, wherein the polymeric outer structure further comprises longitudinal ribs protruding radially outward from the central portion of the wall, wherein the longitudinal ribs extend along a direction of a longitudinal axis of the balloon and are spaced apart from one another in a circumferential direction around the balloon.

12. The delivery apparatus of claim 11, wherein the intersecting struts protrude radially outward from both the proximal and distal end portions of the wall and proximal and distal ends of each of the longitudinal ribs are connected to the intersecting struts.

13. The delivery apparatus of claim 12, wherein the at least one shoulder comprises a plurality of shoulders protruding radially outward from the distal and proximal ends of at least one of the longitudinal ribs.

14. The balloon of any one of claims 11-13, wherein the at least one shoulder has a greater radial thickness than a radial thickness of the longitudinal ribs.

15. The delivery apparatus of any one of claims 9-14, wherein the polymeric outer structure is integrally molded with the wall of the balloon.

16. The delivery apparatus of any one of claims 9-14, wherein the polymeric outer structure is fused with the wall of the balloon.

17. A method of forming a medical balloon comprising:forming a wall of the balloon from a polymer; andforming a retaining structure from a polymer, wherein the retaining structure comprises a plurality of intersecting struts and a plurality of shoulders, and wherein the retaining structure is joined to an outer surface of the wall and protrudes radially outward therefrom.

18. The method of claim 17, further comprising molding the retaining structure as part of the wall of the balloon.THVMC-24095W00119. The method of claim 17, further comprising fusing the retaining structure with the wall of the balloon using heat welding or bonding.

20. The method of claim 17, further comprising insert-molding the retaining structure into the wall of the balloon.

21. An inflatable medical balloon comprising:a wall extending from a distal end of the balloon to a proximal end of the balloon, wherein the wall comprises a proximal end portion, a distal end portion, and a central portion extending from the proximal end portion to the distal end portion: anda polymeric retaining structure coupled to at least a portion of the wall and protruding radially outward from at least the portion of the wall, wherein the polymeric retaining structure comprises:a plurality of intersecting struts; andone or more shoulders.

22. The inflatable medical balloon of claim 21, wherein each of the one or more shoulders protrudes radially outward further than the plurality of intersecting struts.

23. The inflatable medical balloon of claim 21 or claim 22, wherein the at least the portion of the wall comprises at least one of the proximal end portion and the distal end portion.

24. The inflatable medical balloon of any of claims 21-23, wherein the at least the portion of the wall comprises the central portion.

25. The inflatable medical balloon of any of claims 21-24, wherein the polymeric retaining structure further comprises a plurality of longitudinal ribs extending along a direction of a longitudinal axis of the balloon, wherein the longitudinal ribs of the plurality of longitudinal ribs are spaced apart from one another in a circumferential direction around the balloon.THVMC-24095W00126. The inflatable medical balloon of any of claims 21-25, wherein the intersecting struts of the plurality of intersecting struts are joined by one or more zig-zag shaped struts.

27. The inflatable medical balloon of any of claims 21-26, wherein the polymeric retaining structure is integrally formed with the wall.

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