Medical balloons with one or more wire coils

Abstract

A medical device can comprise an inflatable balloon and at least one wire coil extending helically around at least a portion of an outer surface of the balloon. The wire coil can have a first configuration when the balloon is uninflated and can move from the first configuration to a second configuration when the balloon is inflated with an inflation fluid. The wire coil can move from the second configuration back to the first configuration under its own resiliency when the inflation fluid is removed from the balloon. The wire coil can be configured to apply a collapsing force to the balloon when the wire coil moves back to the first configuration. The medical device can have a first wire coil disposed along a distal end portion of the balloon and a second wire coil disposed along a proximal end portion of the inflatable balloon.

Description

MEDICAL BALLOONS WITH ONE OR MORE WIRE COILSCROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U. S. Provisional Application No. 63 / 725,380, filed November 26, 2024, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to wire coils configured to assist in collapsing medical 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, grafts, etc.) 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 the patient’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, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery apparatus so that the prosthetic valve can self-expand to its functional size. 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 patient’s vasculature to a treatment site. After the balloon is inflatedinside the patient’s body, such as to expand a medical implant, the inflation fluid is removed from the balloon to deflate and collapse the balloon.SUMMARY

[0006] Described herein are prosthetic heart valves, delivery apparatuses, and methods for implanting prosthetic heart valves. Also described herein are inflatable medical balloons (also referred to herein as “inflatable balloons,” “medical balloons,” “catheter balloons,” or “balloons”) used to deploy prosthetic implants, and devices and methods for collapsing the inflatable balloons when deflated. The disclosed devices and methods can, for example, more completely and reliably collapse a deflated balloon into a compact, low-profile configuration for improved travel through a body. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatuses.

[0007] A medical device can comprise an inflatable balloon and at least one wire coil extending helically around at least a portion of an outer surface of the balloon. In addition to these components, a medical device can further comprise one or more of the components disclosed herein.

[0008] In some examples, the at least one wire coil can have a first configuration when the balloon is uninflated and a second configuration, where the at least one wire coil can move from the first configuration to the second configuration.

[0009] In some examples, the at least one wire coil can move from the first configuration to the second configuration when the balloon is inflated with an inflation fluid.

[0010] In some examples, the at least one wire coil can move from the second configuration back to the first configuration under its own resiliency when the inflation fluid is removed from the balloon.

[0011] In some examples, the at least one wire coil can be configured to apply a collapsing force to the balloon when the at least one wire coil moves from the second configuration to the first configuration.

[0012] In some examples, the at least one wire coil can have a helical shape comprising a plurality of turns defining an inner lumen.

[0013] In some examples, a first portion of the inner lumen can have a first diameter when the at least one wire coil is in the first configuration and a second diameter when the at leastone wire coil is in the second configuration, where the second diameter is greater than the first diameter.

[0014] In some examples, a diameter of a second portion of the inner lumen can be the same in the first and second configurations.

[0015] In some examples, the at least one wire coil can have a helical shape comprising a plurality of turns disposed around a central longitudinal axis of the inflatable balloon.

[0016] In some examples, a first portion of the plurality of turns can have a first pitch when the at least one wire coil is in the first configuration and a second pitch when the at least one wire coil is in the second configuration, wherein the second pitch is less than the first pitch.

[0017] In some examples, an end of the at least one wire coil can be displaced from a first position to a second position along the central longitudinal axis when the at least one wire coil is moved to from the first configuration to the second configuration.

[0018] In some examples, the end of the at least one wire coil can be displaced from the second position to the first position when the at least one wire coil is moved from the second configuration to the first configuration.

[0019] In some examples, an end portion of the at least one wire coil can comprise a loop.

[0020] In some examples, the at least one wire coil can comprise first and second strands connected to each other at a looped end portion, where the first and second strands can extend helically around the outer surface of the balloon.

[0021] In some examples, the at least one wire coil can extend around a proximal portion of the balloon.

[0022] In some examples, the at least one wire coil can extend around a distal portion of the balloon.

[0023] In some examples, the at least one wire coil can comprise a first wire coil that extends around a proximal portion of the balloon.

[0024] In some examples, the first wire coil can have a helical shape comprising a plurality of turns defining a first inner lumen.

[0025] In some examples, a proximal portion of the first inner lumen can have a first diameter when the first wire coil is in the radially collapsed configuration and a second diameter, greater than the first diameter, when the first wire coil is in the radially expanded configuration.

[0026] In some examples, a diameter of a distal portion of the first inner lumen can be the same when the first wire coil is in the radially collapsed and expanded configurations.

[0027] In some examples, the at least one wire coil can comprise a second wire coil that extends around a distal portion of the balloon.

[0028] In some examples, the second wire coil can have a helical shape comprising a plurality of turns defining a second inner lumen.

[0029] In some examples, a distal portion of the second inner lumen can have a first diameter when the second wire coil is in the radially collapsed configuration and a second diameter, greater than the first diameter, when the second wire coil is in the radially expanded configuration.

[0030] In some examples, a diameter of a proximal portion of the second inner lumen can be the same when the second wire coil is in the radially collapsed and expanded configurations.

[0031] In some examples, a proximal end portion of the first wire coil and a distal end portion of the second wire coil comprise loops.

[0032] In some examples, each of the first and second wire coils can be doubled over to form loops that extend helically around the balloon.

[0033] In some examples, each of the first and second wire coils can comprise first and second strands connected to each other at a looped end portion, wherein the first and second strands can extend helically around the outer surface of the balloon.

[0034] In some examples, the balloon can comprise a central portion and the at least one wire coil does not extend around the central portion.

[0035] In some examples, the at least one wire coil can comprise a shape-memory material.

[0036] In some examples, the shape-memory material can comprise Nitinol.

[0037] In some examples, a medical device comprises an inflatable balloon and at least one wire coil extending helically around at least a portion of an outer surface of the balloon, wherein the at least one wire coil has a first configuration when the balloon is uninflated and can move from the first configuration to a second configuration when the balloon is inflated with an inflation fluid. The at least one wire coil can move from the second configuration back to the first configuration under its own resiliency when the inflation fluid is removed from the balloon, wherein the at least one wire coil is configured to apply a collapsing force to the balloon when the at least one wire coil moves from the second configuration to the first configuration.

[0038] In some examples, a medical device comprises an inflatable balloon, a first wire coil disposed around an outer surface of the inflatable balloon along a distal end portion of the balloon, and a second wire coil disposed around the outer surface of the inflatable balloon along a proximal end portion of the inflatable balloon, wherein the first and second wire coils have a radially expanded configuration and a radially collapsed configuration, and wherein the first and second wire coils move from the radially collapsed configuration to the radially expanded configuration when the inflatable balloon is inflated, and the first and second wire coils move back to the radially collapsed configuration under their own resiliency when the inflatable balloon is deflated to assist in collapsing the inflatable balloon.

[0039] In some examples, a medical device comprises one or more of the components recited in Examples 1-22 and 33 below.

[0040] A method can comprise receiving a medical device comprising a balloon and at least one wire coil extending helically around at least a portion of an outer surface of the balloon in a first configuration. In addition to these steps, a method can further comprise one or more of the steps disclosed herein.

[0041] In some examples, the method can comprise inflating the balloon from an uninflated state to an inflated state by introducing an inflation fluid into the balloon, which causes the at least one wire coil to move from the first configuration to a second configuration.

[0042] In some examples, the method can comprise removing the inflation fluid from the balloon, which allows the at least one wire coil to move from the second configuration back to the first configuration under its own resiliency, thereby applying a collapsing force to the balloon to assist in collapsing the balloon.

[0043] In some examples, introducing the inflation fluid into the balloon can cool the at least one wire coil such that it becomes ductile or less elastic.

[0044] In some examples, introducing the inflation fluid into the balloon can cool the at least one wire coil to a temperature below a transition temperature of the Nitinol.

[0045] In some examples, removing the inflation fluid from the balloon can allow the at least one wire coil to warm to body temperature and become elastic or more elastic.

[0046] In some examples, the at least one wire coil can be warmed to a temperature above a transition temperature of the Nitinol.

[0047] In some examples, the first configuration of the at least one wire coil can be a radially collapsed configuration.

[0048] In some examples, the second configuration of the at least one wire coil can be a radially expanded configuration.

[0049] In some examples, the first configuration of the at least one wire coil can be an axially expanded configuration.

[0050] In some examples, the second configuration can be an axially compressed configuration.

[0051] In some examples, the at least one wire coil can comprise a first wire coil disposed around a proximal end portion of the balloon.

[0052] In some examples, the at least one wire coil can comprise a second wire coil disposed around a distal end portion of the balloon.

[0053] In some examples, a method comprises receiving a medical device comprising a balloon and at least one wire coil extending helically around at least a portion of an outer surface of the balloon, wherein the at least one wire coil is in a first configuration; inflating the balloon from an uninflated state to an inflated state by introducing an inflation fluid into the balloon, which causes the at least one wire coil to move from the first configuration to a second configuration; and removing the inflation fluid from the balloon, which allows the at least one wire coil to move from the second configuration back to the first configuration under its own resiliency, thereby applying a collapsing force to the balloon to assist in collapsing the balloon.

[0054] In some examples, a method comprises one or more of the steps recited in Examples 23-32 below.

[0055] 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

[0056] FIG. 1 is a side view of a prosthetic heart valve, according to an example.

[0057] FIG. 2 is a side view of a delivery apparatus for a prosthetic heart valve, where the delivery apparatus comprises a balloon catheter, according to an example.

[0058] FIG. 3 is a side view of an inflatable balloon, according to an example.

[0059] FIG. 4A is a side view of two wire coils disposed around the inflatable balloon of FIG.3 in a radially collapsed configuration, according to an example.

[0060] FIG. 4B is a side view of the inflatable balloon and the wire coils of FIG. 4A, in a radially expanded configuration.

[0061] FIG. 5A is a side view of two wire coils disposed around the inflatable balloon of FIG.3 in a radially collapsed configuration, according to another example.

[0062] FIG. 5B is a side view of the inflatable balloon and the wire coils of FIG. 5A, in a radially expanded configuration.

[0063] FIG. 6 is a side view of two wire coils disposed around the inflatable balloon of FIG.3, where each wire coil comprises a doubled over wire forming a helical loop, according to an example.

[0064] FIG. 6A is enlarged view of a portion of one of the wire coils of FIG. 6.

[0065] FIG. 7 is a side view of two wire coils surrounding an inflatable balloon, where an end portion of each wire coil comprises a loop, according to an example.DETAILED DESCRIPTIONGeneral Considerations

[0066] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0067] 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 insome 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.

[0068] 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 terns “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 tern “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.

[0069] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (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.

[0070] 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 animplementation” 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.

[0071] It will be understood that the benefits and advantages described herein can relate to one implementation or can relate to several implementations. Aspects described in connection with one implementation are intended to be able to be used with the other implementation. Any explanation in connection with one implementation applies to similar features of the other implementations, and elements of multiple implementations can be combined to form other implementations. The implementations are not limited to those that solve any or all of the stated problems or those that have any or all of the stated benefits and advantages.

[0072] All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. 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 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.

[0073] The techniques, methods, processes, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.

[0074] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”Overview of the Disclosed Technology

[0075] Described herein are examples of balloon catheters that can be used in various medical procedures. In some examples, the disclosed balloon catheters can comprise adelivery apparatus that can be used to navigate a subject’s vasculature to deliver an implantable, expandable medical device (for example, a prosthetic heart valve), tools, agents, or other therapy to a location within the body of a subject (e.g., a living subject, a simulation). Examples of procedures in which the catheters are useful include neurological, urological, gynecological, fertility (for example, in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal, and procedures including access in any body duct or cavity. Particular examples include placing implants, including stents, grafts, embolic coils, and the like; positioning imaging devices and / or components thereof, including ultrasound transducers; and positioning energy sources, for example, for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, and the like. In some examples, the disclosed balloon catheters can be used for performing procedures for opening or widening a blood vessel or heart valve annulus, such as an angioplasty or a valvuloplasty.

[0076] As introduced above, balloon catheters can be used to expand and deploy implantable medical devices (also referred to herein as “prosthetic implants”) within portions of a body, for example, within a subject’s vasculature and / or heart. Examples of prosthetic implants can comprise prosthetic heart valves, stents, and grafts.

[0077] In some instances, a prosthetic implant can be crimped or assembled onto an inflatable balloon of a balloon catheter in a compressed state for delivery to and deployment at an implantation site. The balloon can be inflated once the prosthetic implant is positioned at the implantation site, expanding the prosthetic implant into a deployed state. The balloon can be deflated and returned to a collapsed state after deploying the prosthetic implant. In some instances, upon removal of the inflation fluid, the balloon collapses into a flattened or irregular configuration, which can make it more difficult to withdraw the balloon from the subject’s body. In particular, an irregularly shaped balloon can be difficult to retract back through an introducer sheath. Therefore, a need exists for a device that exerts a radial force onto the balloon in order to collapse the balloon into a predictable (e.g., cylindrical) and compact configuration for decreasing retrieval forces and facilitating removal of the balloon from a subject’s a body.

[0078] Described herein are devices that assist in collapsing a deflated medical balloon into a small, compact, and substantially cylindrical configuration for easier withdrawal of the balloon from a subject's body. The devices described herein can comprise at least one wirecoil disposed around an outer surface of an inflatable medical balloon. First and / or second wire coils can be configured to apply a collapsing, radial force to the balloon when the balloon is deflated. In some examples, a wire coil can comprise a single strand. In some examples, a wire coil can comprise a single strand doubled (or tripled, etc.) over. In some examples, a wire coil can comprise two or more strands coupled together.

[0079] In an example, an implantable medical device can be a prosthetic heart valve as seen in FIG. 1. FIG. 2 illustrates an example of a delivery apparatus for a prosthetic heart valve, where the delivery apparatus comprises a balloon catheter comprising an inflatable balloon. FIG. 3 shows a side view of an inflatable balloon in an inflated state, according to an example. FIGS. 4A-7 illustrate examples of at least one wire coil disposed around the balloon of FIG. 3, where the at least one wire coil is adapted to apply a collapsing force on the balloon during deflation.Examples of the Disclosed Technology

[0080] Prosthetic implants (e.g., prosthetic valves, stents, grafts, etc.) 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 implant can be expanded to the radially expanded state (e.g., a deployed state) once the prosthetic implant reaches an implantation site. It is understood that 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.

[0081] FIG. 1 shows an example prosthetic implant in the form of a prosthetic valve 100, according to an example. Although the examples described herein are primarily directed to prosthetic heart valves, the disclosed devices and methods can be used with various other prosthetic implants, including, for instance, stents and grafts.

[0082] 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 diseasedtricuspid 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.

[0083] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, 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.

[0084] The prosthetic valve 100 can comprise a frame 112, a valvular structure 114, an inner skirt 116, and a perivalvular outer sealing member or outer skirt 118. The prosthetic valve 100 can comprise an inflow end portion 115 and an outflow end portion 119, and an intermediate portion 117 extending therebetween.

[0085] The valvular structure 114 can comprise a plurality of leaflets 140 collectively forming a leaflet structure. In some examples, the valvular structure 114 can comprise three leaflets 140 arranged in a tricuspid arrangement. However, there can be a greater or fewer number of leaflets 140. The leaflets can be secured to one another at their adjacent sides to form commissures 122 of the valvular structure 114. The lower edge of the valvular structure 114 can have an undulating, curved scalloped shape, and can be secured to the inner skirt 116 by sutures (not shown). In some examples, the leaflets 140 can be formed of pericardial tissue (such as bovine pericardial tissue), biocompatible synthetic materials, or other various suitable natural or synthetic materials as known in the art and described in U. S. Patent No. 6,730,118, which is incorporated by reference herein.

[0086] The frame 112 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol) as known in the art. When constructed of a plastically-expandable material, the frame 112(and thus the valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a subject by an inflatable catheter balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 112 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0087] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 112) include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 112 can comprise stainless steel. In some examples, the frame 112 can comprise cobalt-chromium. In some examples, the frame 112 can comprise nickel-cobalt-chromium. In some examples, the frame 112 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0088] The inner skirt 116 and / or the outer skirt 118 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the skirts 116, 118 can comprise a fabric having interlaced yams 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. Example fabrics having a plush nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the skirts 116, 118 can comprise a fabric without interlaced yarns or fibers or randomly interlaced yarns or fibers, such as felt or an electrospun fabric. Example materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the skirts 116, 118 can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, poly etheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the skirts 116, 118 can comprisea sponge material or foam, such as polyurethane foam. In some examples, the skirts 116, 118 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0089] FIG. 2 shows a delivery apparatus 200, according to an example, in the form of a balloon catheter that can be used to implant a prosthetic implant. In some examples, the delivery apparatus 200 can be used to implant an expandable prosthetic heart valve (for example, the prosthetic valve 100 of FIG. 1, or any of the other prosthetic heart valve described herein, or other types of prosthetic implants). In some examples, the delivery apparatus 200 can be specifically adapted for use in introducing a prosthetic heart valve into a heart.

[0090] In some examples, e.g., the example of FIG.2, a delivery apparatus 200 comprises a handle 202 and a steerable, outer shaft 204 extending distally from the handle 202.

[0091] The delivery apparatus 200 can further comprise an intermediate shaft 206 (also referred to herein as a “balloon shaft”) that extends proximally from the handle 202 and distally from the handle 202, the portion extending distally from the handle 202 also extending coaxially through the outer shaft 204. Additionally, the delivery apparatus 200 can further comprise an inner shaft 208 extending distally from the handle 202 coaxially through the intermediate shaft 206 and the outer shaft 204 and proximally from the handle 202 coaxially through the intermediate shaft 206.

[0092] The outer shaft 204 and the intermediate shaft 206 can be configured to translate (for example, move) longitudinally, along a central longitudinal axis 220 of the delivery apparatus 200, relative to one another to facilitate delivery and positioning of a prosthetic heart valve at an implantation site in a subject's body.

[0093] The intermediate shaft 206 can include a proximal end portion 210 that extends proximally from a proximal end of the handle 202, to an adaptor 212. A rotatable knob 214 can be mounted on the proximal end portion 210 and can be configured to rotate the intermediate shaft 206 around the central longitudinal axis 220 and relative to the outer shaft 204.

[0094] The adaptor 212 can include a first port 238 configured to receive a guidewire therethrough and a second port 240 configured to receive fluid (for example, inflation fluid) from a fluid source. The second port 240 can be fluidly coupled to an inner lumen of the intermediate shaft 206.

[0095] The balloon shaft 206 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 204 when a distal end of the outer shaft 204 is positioned away from an inflatable balloon 218 of the delivery apparatus 200. A distal end portion of the inner shaft 208 can extend distally beyond the distal end portion of the balloon shaft 206.

[0096] A proximal end 241 of the balloon 218 can be coupled to the distal end portion of the balloon shaft 206 or the inner shaft 208. In some examples, a distal end 242 of the balloon 218 can be coupled to a distal end of the delivery apparatus 200, such as to a nose cone 222 (as shown in FIG. 2). An intermediate portion of the balloon 218 can overlay a valve mounting portion 224 of a distal end portion of the delivery apparatus 200. The valve mounting portion 224 and the intermediate portion of the balloon 218 can be configured to receive a prosthetic heart valve in a radially compressed (e.g., crimped) state. For example, as shown schematically in FIG. 2, a prosthetic heart valve 250 (which can be any of the prosthetic heart valves described herein, such as for example, prosthetic heart valve 100) can be mounted around the balloon 218, at the valve mounting portion 224 of the delivery apparatus 200.

[0097] As seen in FIG. 2, the outer shaft 204 can include a distal tip portion 228 mounted on its distal end. The outer shaft 204 and the balloon shaft 206 can be translated axially relative to one another to position the distal tip portion 228 adjacent to a proximal end of the valve mounting portion 224, when the prosthetic heart valve 250 is mounted in the radially compressed state on the valve mounting portion 224 (as shown in FIG. 2) and during delivery of the prosthetic heart valve to the target implantation site. As such, the distal tip portion 228 can be configured to resist movement of the prosthetic heart valve 250 relative to the balloon 218 proximally, in the axial direction, relative to the balloon 218, when the distal tip portion 228 is arranged adjacent to a proximal side of the valve mounting portion 224.

[0098] An annular space can be defined between an outer surface of the inner shaft 208 and an inner surface of the balloon shaft 206 and can be configured to receive fluid from a fluid source via the second port 240 of the adaptor 212. The annular space can be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 208 and an inner surface of the balloon 218. As such, fluid from a fluid source can flow to the fluid passageway from the annular space to inflate the balloon 218 and radially expand and deploy the prosthetic heart valve 250.

[0099] In some examples, prior to crimping the prosthetic valve 250 on the balloon 218 of the delivery apparatus 200, the user can perform a cyclic “de-airing” process that involves pushing an inflation fluid from a fluid source into the balloon 218 and then withdrawing the fluid out of the balloon 218. The fluid source can be a syringe and can be fluidly connected to the port 240 via a conduit (for example, flexible tubing). The de-airing process can be more effective when the balloon 218 is allowed to at least partially inflate. However, inflation of the balloon 218 can result in un-folding of the balloon 218, which can inhibit or prevent the balloon 218 from returning to its folded state when the inflation fluid is removed from the balloon 218. Further details regarding the de-airing process is disclosed in WIPO Publication No. WO2022 / 046585, which is incorporated herein by reference.

[0100] Referring back to FIG. 2, an inner lumen of the inner shaft can be configured to receive a guidewire therethrough, for navigating the distal end portion of the delivery apparatus 200 to the target implantation site.

[0101] The handle 202 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 200. In the illustrated example, for example, the handle 202 includes an adjustment member, such as the illustrated rotatable knob 260, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 202 through the outer shaft 204 and have a distal end portion affixed to the outer shaft 204 at or near the distal end of the outer shaft 204. Rotating the knob 260 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 200. Further details on steering or flex mechanisms for the delivery apparatus can be found in U. S. Patent No.9,339,384, which is incorporated by reference herein.

[0102] The handle 202 can further include an adjustment mechanism 261 including an adjustment member, such as the illustrated rotatable knob 262, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 278. The adjustment mechanism 261 is configured to adjust the axial position of the intermediate shaft 206 relative to the outer shaft 204 (for example, for fine positioning at the implantation site). Further details on the delivery apparatus 200 can be found in PCT Publication No.WO2022 / 046585, which is incorporated by reference herein.

[0103] FIG. 3 is a side view of a catheter balloon 300, according to another example, where the balloon 300 is shown in a radially expanded, inflated state. It should be appreciated thatthe balloons described herein can be used with any suitable apparatus(es) and can be coupled to any suitable shaft or other component(s) (e.g., nosecone) of an assembly. For example, the balloon 300 (or any other balloon described herein) can be used with the delivery apparatus 200 in lieu of the balloon 218 to expand a prosthetic implant. The balloon 300 can comprise an inflatable main body 320 configured to be inflatable between a deflated state and an inflated state about a central longitudinal axis 321. The main body 320 can comprise a proximal end portion 330, a distal end portion 332 distally disposed relative to the proximal end portion 330, and an intermediate portion 336 extending therebetween. The proximal end portion 330 can comprise a proximal tapered portion 331 (which can also be referred to herein as a “proximal cone portion” or “proximal conical portion”) and a proximal leg 340 extending proximally from the proximal tapered portion 331. The distal end portion 332 can comprise a distal tapered portion 333 (which can also be referred to herein as a “distal cone portion” or “distal conical portion”) and a distal leg 342 extending distally from the distal tapered portion 333.

[0104] The proximal leg 340 can be configured to be coupled to a shaft of a delivery apparatus (for example, the intermediate shaft 206 in FIG. 2) and the distal leg 342 can be configured to be coupled to a distal end component (for example, the nose cone 222 in FIG.2). The intermediate portion 336, which in some examples can be referred to as a working portion of the catheter balloon 300, can be configured to receive a prosthetic implant (for example, any one of prosthetic heart valves 100, 250, or any other prosthetic implant described herein) in a radially compressed state. In some examples, the proximal leg 340, the distal leg 342, the proximal tapered portion 331, the intermediate portion 336, and the distal tapered portion 333 can be integrally formed as a single component.

[0105] Each one of the proximal tapered portion 331, the intermediate portion 336, and the distal tapered portion 333 can define a maximum diameter in a radial direction. As shown in FIG. 3, the maximum diameters of the proximal tapered portion 331, the intermediate portion 336, and the distal tapered portion 333 are equal, such that the diameters of the proximal and distal tapered portions 331 and 333 taper from the maximum diameter of the cylindrical intermediate portion 336 towards their respective ends of the catheter balloon 300.

[0106] In some examples, the maximum diameters of the proximal tapered portion 331, the intermediate portion 336, and the distal tapered portion 333 can be equal or substantially equal (for example, within 10%). As shown in FIG. 3, the proximal tapered portion 331 andthe distal tapered portion 333 each have a conical or frustoconical shape when the balloon is inflated. In some examples, the proximal tapered portion 331 and the distal tapered portion 333 can have a hemispherical, a semi-ellipsoid shape, or a bulbous shape when the balloon is inflated.

[0107] The main body 320 of the catheter balloon 300 can define an outer surface 350. The outer surface 350 can be a radially outwards-facing surface of the main body 320. The outer surface 350 can define different sections. For example, the outer surface 350 of the balloon 300 can be divided into a proximal section 352 (which is also referred to herein as a “proximal outer surface” and / or a “proximal outer surface section”), an intermediate section 354 (which is also referred to herein as an “intermediate outer surface” and / or an “intermediate outer surface section”), and a distal section 356 (which is also referred to herein as a “distal outer surface” and / or a “distal outer surface section”). The proximal section 352 of the outer surface 350 can be the outer surface of the proximal tapered portion 331. The intermediate section 354 of the outer surface 350 can be the outer surface of the intermediate portion 336. The distal section 356 of the outer surface 350 can be the outer surface of the distal tapered portion 333.

[0108] The balloon 300 (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®, Grilamid L25, a polyester, such as polyethylene terephthalate (PET), polybutylene terephthalate, a thermoplastic elastomer copolyester (such as Hytrel®), or combinations thereof.

[0109] As described above, the balloon 300 can be inflated into an expanded or a partially expanded state by pushing an inflation fluid from a fluid source into the balloon 300. In some instances, the balloon 300 can be inflated to deploy a prosthetic implant. In some instances, the balloon 300 can be inflated or partially inflated as part of the de-airing process described above. The inflation fluid can be withdrawn from the balloon 300 to deflate the balloon 300 into a collapsed configuration. As noted above, in some instances, the balloon 300 may collapse in a flattened, irregular manner when the inflation fluid is withdrawn.Advantageously, in some of the examples described herein, at least one resilient wire coil can be configured around the outer surface 350 of the balloon 300 to assist in collapsing the balloon 300 into a predictable, low-profile configuration for improved movement through a subject’s vasculature and / or an introducer sheath.

[0110] In some examples, the balloon 300 can have at least one surrounding wire coil. As shown in FIG. 4A, a first wire coil 402 and a second wire coil 404 can be configured to extend helically around the outer surface 350 of the balloon 300. In a radially collapsed configuration 400a (also referred to herein as a “collapsed configuration”), the first and second wire coils 402, 404 can urge the balloon 300 into a compact, compressed state. In some examples, the wire coils 402, 404 are shape-set in the radially collapsed state or configuration 400a (as shown in FIG. 4A) and can radially expand to a radially expanded state or configuration 400b upon inflation of the balloon (as shown in FIG. 4B), and return to the radially collapsed configuration under its own resiliency when the inflation fluid is removed from the balloon, as further described in detail below.

[0111] The first and second wire coils (also referred to herein as “first and second coils”) 402, 404 can comprise wires 406 and 407, respectively, each made of a super elastic and / or shape-memory material (e.g., Nitinol, shape memory polymers, elastomers, or combinations thereof). The wires 406 and 407 can be shape-set in the radially collapsed configuration 400a in which the wires have a helical shape.

[0112] The first wire coil 402 can be adapted to extend helically around distal portions of the balloon 300, for example, the distal leg 342, the distal tapered portion 333, and a distal portion of the intermediate portion 336. The first wire coil 402 can have a distal end 410 and a proximal end 412 with a formed, shape-set axial length 416 extending therebetween. In some examples, the shape-set axial length 416 can be specified to ensure that the first wire coil 402 is arranged over portions of the intermediate portion 336 of the balloon 300. A length of the wire 406 when straightened can be specified to ensure that the wire 406 is sufficiently long to be formed into the helical shape shown in FIG. 4A. In some examples, the distal end 410 of the first wire coil 402 can be attached to the distal end 312 of the balloon 300 using an adhesive, a glue, or other bonding material. In some examples, the proximal end 412 of the first wire coil 402 can be attached to the intermediate portion 336 of the balloon 300 using an adhesive, a glue, or other bonding material. In some examples, the proximal end 412 of the first wire coil 402 is a free end that is not connected or fixed to the outer surface 350 of the balloon 300.

[0113] The first wire coil 402 in FIG. 4A can have a plurality of helical turns defining a first inner lumen disposed around the central longitudinal axis 321 of the balloon 300. In the collapsed configuration 400a of FIG. 4A, the first inner lumen can have a first diameter 414extending along the entire length 416 of the first wire coil 402. In other words, the first inner lumen can have a constant or substantially constant first diameter 414 (for example, within 5%) along the length 416 of the first wire coil 402 in the collapsed configuration 400a.

[0114] As seen in FIG. 4A, the helical turns of the first wire coil 402 can have a first pitch 418 between each adjacent turn along the length 416, where the pitch is defined as an axial distance between adjacent turns along the central longitudinal axis 321. In some examples, the spacing between turns of the first wire coil 402 can be the same or substantially the same (for example, + / - 2 mm) between adjacent turns along the length 416. In some examples, the first pitch 418 can vary between adjacent turns along the central longitudinal axis 321. The first pitch 418 can be specified to ensure selected portions of the balloon 300 experience a sufficient external collapsing force to ensure a compact and consistent collapsed shape.

[0115] The second wire coil 404 can be adapted to extend helically around proximal portions of the balloon 300, for example, the proximal leg 340, the proximal tapered portion 331, and a proximal portion of the intermediate portion 336. The second wire coil 404 can have a distal end 426 and a proximal end 424 with a formed and set axial length 430 therebetween. In some examples, the shape-set axial length 430 can be specified to ensure that the second wire coil 404 is arranged over portions of the intermediate portion 336 of the balloon 300. A length of the wire 407 when straightened can be specified to ensure that the wire 407 is sufficiently long to be formed into the helical shape shown in FIG. 4A. In some examples, the proximal end 424 of the second wire coil 404 can be attached to the proximal end 310 of the balloon 300 using an adhesive, a glue, or other bonding material. In some examples, the distal end 426 of the second wire coil 404 can be attached to the intermediate portion 336 of the balloon 300 using an adhesive, a glue, or other bonding material. In some examples, the distal end 426 of the second wire coil 404 is a free end that is not connected or fixed to the outer surface 350 of the balloon 300.

[0116] The second wire coil 404 in FIG. 4A can have a plurality of helical turns defining a second inner lumen disposed around the central longitudinal axis 321. In the collapsed configuration 400a of FIG. 4A, the second inner lumen can have a first diameter 434 extending along the entire length 430 of the second wire coil 404. In other words, the second inner lumen can have a constant or substantially constant first diameter 434 (for example, within 5 %) along the length 430 of the second wire coil 404.

[0117] As seen in FIG. 4A, the helical turns of the second wire coil 404 can have a first pitch 440 between each adjacent turn along the length 430. In some examples, the spacing between the turns of the second wire coil 404 can be the same or substantially the same between adjacent turns along the length 430. In some examples, the first pitch 440 can vary between adjacent turns along the central longitudinal axis 321. The first pitch 440 can be specified to ensure selected portions of the balloon 300 experience a sufficient external collapsing force to ensure a compact and consistent collapsed shape.

[0118] In some examples, the first pitch 440 of the second wire coil 404 can be the same or substantially the same as the first pitch 418 of the first wire coil 402. In some examples, the first pitches 418, 440 can be different from each other. In some examples, each of the first pitches 418, 440 can specified according to a desired envelope size and balloon shape when collapsed.

[0119] In some examples, the first and second wire coils 402, 404 can be coaxial with each other and the central longitudinal axis 321. Additionally, the first diameter 434 of the second inner lumen can be equal or substantially equal (for example, within 5%) to the first diameter 414 of the first inner lumen. In this way, the first and second wire coils 402, 404 can form axially aligned, cylindrically shaped first and second inner lumens in the collapsed configuration 400a that compress the balloon 300 into a compact cylindrical shape as shown in FIG. 4A.

[0120] As noted above, the balloon 300 can be inflated into an expanded or a partially expanded state by pushing an inflation fluid from a fluid source into the balloon 300. In some examples, the inflation fluid can be stored at the fluid source at a temperature (for example, a room temperature such as 70 degrees F, a temperature cooler than room temperature, or the like) that is cooler than a typical internal body temperature (e.g., 98.6 degrees F). When inside a subject, the balloon 300 and the first and second wire coils 402, 404 can reach a steady state temperature that matches the internal body temperature of the subject.

[0121] In some examples, the coils 402, 404 are made from Nitinol having a transition temperature (the temperature at which the Nitinol transitions from a lower temperature martensite to a higher temperature austenite) greater than the temperature of the inflation fluid. In some examples, the transition temperature is greater than 70 degrees F, such as 98.6degrees F. As noted above, the coils 402, 404 can be shape set in the radially collapsed configuration.

[0122] When the inflation fluid is introduced into the balloon 300, the inflation fluid can cool the surrounding first and second wire coils 402, 404, causing the coil material (for example, Nitinol or any other pseudo-elastic material) to become ductile and relatively soft at the lower temperature. More specifically, the coil material can become martensitic when below the transition temperature of the metal, which can allow the first and second wire coils 402, 404 to more easily radially expand with the balloon 300 as the balloon 300 is inflated. As such, when cooled, the first and second wire coils 402, 404, provide a reduced radial biasing force against the balloon which enables the balloon 300 to more easily inflate.

[0123] For example, as seen in FIG. 4B, the first and second wire coils 402, 404 (or portions thereof) can be expanded with the balloon 300 into a radially expanded configuration 400b. A proximal end portion of the first wire coil 402 can be displaced radially outward such that the proximal end portion of first wire coil 402 has a second diameter 450 around the intermediate portion 336 of the balloon 300. The intermediate portion 413 of the first wire coil 402 can similarly expand to match an expanded outer profile of the distal tapered portion 333 of the balloon 300, such that it tapers from the second diameter 450 to the first diameter 414. A distal portion of the first wire coil 402 surrounding the distal leg 342 of the balloon 300 can remain unchanged having the same first diameter 414 as in the collapsed configuration 400a. Accordingly, the proximal portion of the first inner lumen can have a greater diameter than a distal portion of the first inner lumen, as shown in FIG. 4B.

[0124] Similarly, a distal portion of the second wire coil 404 can be displaced radially outward such that the second wire coil 404 has a second diameter 452 around the intermediate portion 336 of the balloon 300. In some examples, as shown in FIG. 4B, the intermediate portion 336 is cylindrical and the second diameter 450 of the first wire coil 402 equals or substantially equals (for example, within 5%) the second diameter 452 of the second wire coil 404. The intermediate portion 431 of the second wire coil 404 can expand to match an expanded outer profile of the proximal tapered portion 331 of the balloon 300, such that it tapers from the second diameter 452 to the first diameter 434. A proximal portion of the second wire coil 404 surrounding the proximal leg 340 of the balloon 300 can remain unchanged having the same first diameter 434 as in the collapsed configuration 400a.Accordingly, the distal portion of the second inner lumen can have a greater diameter than a proximal portion of the second inner lumen, as shown in FIG. 4B.

[0125] In some examples, as seen in FIG. 4A-4B, the formed length 416 of the first wire coil 402 in the radially expanded configuration 400b can be the same and / or substantially the same (e.g., within 5%) as its formed length in the collapsed, shape-set configuration 400a. In other words, the first wire coil 402, in some examples, does not axially compress when moving from the collapsed configuration 400a to the radially expanded configuration 400b. Instead, the windings of the first wire coil 402 along the distal tapered portion 333 and the intermediate portion 336 of the balloon can increase in diameter in the radially expanded configuration 400b to accommodate the increase in balloon diameter. In some examples, the first wire coil 402 can axially compress and increase in diameter as the balloon is inflated.

[0126] As seen in FIG. 4B, the formed length 430 of the second wire coil 404 in the radially expanded configuration 400b can be the same and / or substantially the same (e.g., within 5%) as its formed length in the collapsed, shape-set configuration 400a. In other words, the second wire coil 404, in some examples, does not axially compress when moving from the collapsed configuration 400a to the radially expanded configuration 400b. Instead, the windings of the second wire coil 404 along the proximal tapered portion 331 and the intermediate portion 336 of the balloon can increase in diameter in the radially expanded configuration 400b to accommodate the increase in balloon diameter. In some examples, the second wire coil 404 can axially compress and increase in diameter as the balloon is inflated.

[0127] To collapse the balloon 300, the inflation fluid is withdrawn from the balloon. With the inflation fluid removed, the first and second wire coils 402, 404 can warm up to the transition temperature of the metal (for example, a temperature equal to the internal body temperature of the subject), thus increasing in elasticity. At the higher temperature (e.g., at or above the Nitinol transition temperature), the first and second wire coils 402, 404 can become elastic and revert back to their original, pre-formed shape set shapes under their own resiliency (e.g., the helical shapes as seen in FIG. 4A). Movement of the first and second wire coils 402, 404 back into the collapsed, shape-set configuration 400a of FIG. 4A can result in an increase in collapsing, radial force applied to the balloon 300. This collapsing, radial force can advantageously assist in collapsing the balloon 300 to the lower-profile, cylindrical configuration shown in FIG. 4A to facilitate removal of the balloon from the subject’s body. As such, the first wire coil 402, the second wire coil 404, or both the first andsecond wire coils 402, 404 can be arranged around the balloon 300 to assist selected regions in collapsing to a more predictable shape.

[0128] In some examples, the coils 402, 404 need not undergo a phase change in response to temperature changes when the balloon is inflated and deflated. In some such examples, the coils 402, 404 can remain in the austenite phase of the Nitinol (that is, the coil remains elastic) when the coils are expanded and collapsed.

[0129] In some examples, the balloon 300 can be provided with only one wire coil, such as only the first wire coil 402 or the second wire coil 404.

[0130] As seen in FIGS. 4A-4B, at least one wire coil surrounding an inflatable balloon can be configured to expand in diameter with the balloon during balloon inflation and radially collapse when the balloon is deflated. Alternatively or additionally, at least one wire coil surrounding an inflatable balloon can be configured to axially compress along a central longitudinal axis of the balloon during balloon inflation. As seen in FIG. 5A, a first wire coil 502 and a second wire coil 504 can be configured to extend helically around the outer surface 350 of the balloon 300. In the example of FIGS. 5A-5B, the wire coils 502, 504 have a first configuration 500a and a second configuration 500b. In the first configuration 500a, the wire coils 502, 504 are radially compressed and axially expanded. In the second configuration 500b, the wire coils 502, 504 are radially compressed and axially compressed.

[0131] The first and second wire coils (also referred to herein as “first and second coils”) 502, 504 can comprise wires 506 and 507, respectively, each made of a shape-memory material (e.g., Nitinol). The wires 506 and 507 can be shape-set in the first configuration 500a, in which the wires have a helical shape.

[0132] In the first configuration 500a, the first wire coil 502 can be arranged to extend helically around a distal portion of the balloon 300, specifically the distal leg 342, the distal tapered portion 333, and a distal portion of the intermediate portion 336. The second wire coil 504 can be adapted to extend helically around a proximal portion of the balloon 300, specifically the proximal leg 340, the proximal tapered portion 331, and a proximal portion of the intermediate portion 336. A distal end 510 of the first wire coil 502 and a proximal end 524 of the second wire coil 504 can be secured to the balloon 300. A proximal end 512 of the first wire coil 502 and a distal end 526 of the second wire coil 504 can be free ends that can float relative the outer surface 350 of the balloon 300. In other words, the proximal and distal ends 512, 526 may not be attached or fixed to the balloon 300 and may move axially. Thefirst and second wire coils 502, 504 of FIG. 5A in the first configuration 500a can have substantially the same configuration as the first and second wire coils 402, 404 of FIG. 4A in the radially collapsed configuration 400a. Accordingly, the reference numbers are similarly labeled and the descriptions of the first and second wire coils 402, 404 in the radially collapsed configuration 400a apply to the first and second wire coils 502, 504 in the first configuration 500a and are not repeated here for sake of brevity.

[0133] The balloon 300 of FIG. 5A can be inflated into an expanded or inflated state using inflation fluid, as described above. When cooled by the inflation fluid, the first and second wire coils 502, 504 can become more ductile and move into an axially compressed configuration (also referred to herein as a “second configuration”) 500b as seen in FIG. 5B in which the first and second wire coils 502, 504 are axially compressed. More specifically, the first and second wire coils 502, 504 can be configured to compress axially toward the distal and proximal ends 312, 310 of the balloon 300, respectively, when the balloon 300 inflates.

[0134] As described above, when the balloon 300 expands into the inflated state, the intermediate portion 336 of the balloon 300 expands to the maximum diameter, tapering along the distal tapered portion 333 to the first diameter 514 at the distal leg 342. As the balloon 300 is inflated and diameters of the intermediate portion 336 and the distal tapered portion 333 enlarge, a proximal end portion of the first wire coil 502 can be displaced axially by the distal tapered portion 333 in the distal direction, as indicated by arrow 550. As seen in FIG. 5B, in the second configuration 500b, the first wire coil 502 extends only over the distal leg 342 of the balloon 300, thus allowing the intermediate portion 336 of the balloon 300 to fully expand in a distal region. Similarly, as the balloon 300 is inflated and diameters of the intermediate portion 336 and the proximal tapered portion 331 enlarge, a distal end portion of the second wire coil 504 can be displaced axially by the proximal tapered portion 331 in the proximal direction, as indicated by arrow 552. As seen in FIG. 5B, in the second configuration 500b, the second wire coil 504 extends only over the proximal leg 340 of the balloon 300, thus allowing the intermediate portion 336 of the balloon 300 to fully expand in a proximal region. In some examples, with the first and second wire coils 502, 504 axially compressed onto the distal and proximal legs 342, 340 respectively, the balloon 300 can more easily inflate and fully expand without radial restriction along its intermediate portion 336.

[0135] In this way, the first and second wire coils 502, 504 compress in axial length and maintain or substantially maintain the same first and second diameters 514, 534 along theirrespective compressed lengths (e.g., within 5%). That is, the first inner lumen defined by the first wire coil 502 maintains the same (and / or substantially the same) first diameter 514 in both the first configuration 500a and the second configuration 500b. Similarly, the second inner lumen defined by the second wire coil 504 maintains the same (and / or substantially the same) first diameter 534 in both the first configuration 500a and the second configuration 500b.

[0136] With the balloon 300 inflated and the first and second wire coils 502, 504 in the second configuration 500b, a proximal portion of the first wire coil 502 can have a smaller, compressed pitch compared to a pitch 518b at a distal portion of the first wire coil 502.Similarly, a distal portion of the second wire coil 504 can have a smaller, compressed pitch compared to a pitch 540b at a proximal portion of the second wire coil 504.

[0137] When the inflation fluid is withdrawn to collapse the balloon 300, as described above, the first and second wire coils 502, 504 can become elastic or more elastic and revert back to their original, pre-formed shapes (e.g., the axially expanded helical shapes as seen in FIG. 5A). Movement of the first and second wire coils 502, 504 back into the shape-set configuration 500a of FIG. 5A can lead to in an increase in collapsing, radial force applied to the balloon 300. Specifically, the wire coils 502, 504 can extend axially back over the distal tapered portion 333 and the proximal tapered portion 331, causing the balloon 300 to collapse to the lower-profile, cylindrical configuration shown in FIG. 5A. As such, the first wire coil 502, the second wire coil 504, or both the first and second wire coils 502, 504 can be arranged around the balloon 300 to assist selected regions in collapsing.

[0138] In some examples, the coils 502, 504 need not undergo a phase change in response to temperature changes when the balloon is inflated and deflated. In some such examples, the coils 502, 504 can remain in the austenite phase of the Nitinol (that is, the coil remains elastic) when the coils are axially expanded and compressed.

[0139] In some examples, the balloon 300 can be provided with only one wire coil, such as only the first wire coil 502 or the second wire coil 504.

[0140] In some examples, at least one wire coil can have a looped end portion which can distribute an inward radial force at the end portion over a greater surface area, thus reducing or eliminating the likelihood of damage to the balloon during inflation. As used herein, a “looped end portion” may for a closed loop end portion and / or a partially open loop shapedportion (e.g., a U-shaped / substantially U-shaped end portion; a spiraled end portion; a C-shaped end portion) and / or a curved end portion.

[0141] In some examples, as seen in FIG. 6, a first wire coil 602 and a second wire coil 604 can be arranged around the balloon 300. The first and second wire coils 602, 604 can comprise wires 606 and 607, respectively, each made of a shape-memory material (e.g., Nitinol). The wires 606 and 607 can be doubled over, each forming a doubled stranded arrangement along their respective straightened lengths with a loop or turn at an end. As seen in FIG. 6A, the first wire coil 602 comprises a first strand 608a and a parallel second strand 608b that are connected to each other at a looped end portion 611 defining a free end 612 (the proximal end) of the first wire coil 602. Similarly, the second wire coil 604 comprises a first strand 610a and a parallel second strand 610b that are connected to each other at a looped end portion 625 defining a free end 626 (the distal end) of the second wire coil 604. The doubled wires 606 and 607 can be shape-set into a radially collapsed, three-dimensional arrangement (e.g., a substantially helical shape) as discussed above in relation to FIG. 4A.

[0142] The first wire coil 602 can be configured such that the looped end portion 611 is disposed around a distal region the intermediate portion 336 of the balloon 300. At a distal end 614 of the first wire coil 602, the two distal ends of the strands 608a, 608b can be fixed to the balloon. The second wire coil 604 can be configured such that the looped end portion 625 is disposed around a proximal region of the intermediate portion 336 of the balloon 300. At a proximal end 624 of the second wire coil 604, the two proximal ends of the strands 610a, 610b can be fixed to the balloon. When the intermediate portion 336 of the balloon 300 expands due to inflation, the first and second wire coils 602, 604 can likewise expand as described above regarding FIG. 4B. The looped end portions 611, 625 can distribute any collapsing, radial force applied to the balloon 300 by the ends of the wire coils during inflation over a larger surface area, thus reducing the likelihood of abrasions or punctures to the balloon 300 by the proximal and distal free ends 612, 626 of the first and second wire coils 602, 604. In some examples, the wire coils 602, 604 can transition from a first, axially expanded configuration (like FIG. 5A) to a second, axially compressed configuration (like FIG. 5B) upon inflation and deflation of the balloon.

[0143] In some implementations, at least one wire coil can have a single stranded wire configuration with a looped end portion. As seen in FIG. 7, a first wire coil 702 and a second wire coil 704 can be arranged around the balloon 300. The first and second wire coils 702,702 can comprise wires 706 and 707, respectively, each made of a shape-memory material (e.g., Nitinol). The wires 706 and 707 can have a singled stranded arrangement along their respective straightened lengths with a loop or turn at an end. The single-stranded wires 706 and 707 can be shape-set into a radially collapsed, three-dimensional arrangement (e.g., a substantially helical shape) as discussed above in relation to FIG. 4A.

[0144] The wire 706 can comprise a looped end portion 711 which, when formed into the first wire coil 702, can be arranged at a proximal end 712 of the first wire coil 702. The first wire coil 702 can be configured such that the looped end portion 711 is disposed around a distal region the intermediate portion 336 of the balloon 300. A distal end 710 of the wire coil 702 can be fixed to the balloon. Similarly, the wire 707 can comprise a looped end portion 725 which, when formed into the second wire coil 704, can be arranged at a distal end 726 of the second wire coil 704. The second wire coil 704 can be configured such that the looped end portion 725 is disposed around a proximal region of the intermediate portion 336 of the balloon 300. A proximal end 724 of the wire coil 704 can be fixed to the balloon. In some examples, a proximal end 712 of the wire coil 702 and a distal end 726 of the wire coil 704 can be attached to the intermediate portion 336 of the balloon 300 using an adhesive, a glue, or other bonding material. In some examples, the proximal end 712 of the wire coil 702 and the distal end 726 of the wire coil 704 are free ends that are not connected or fixed to the outer surface 350 of the balloon 300. When the intermediate portion 336 of the balloon 300 expands due to inflation, the first and second wire coils 702, 704 can likewise expand as described above regarding FIG. 4B. The looped end portions 711, 725 can distribute any collapsing, radial force applied to the balloon 300 by the ends of the wire coils during inflation over a larger surface area, thus reducing the likelihood of abrasions or punctures to the balloon 300 by the proximal and distal ends 712, 726 of the first and second wire coils 702, 704. In some examples, the wire coils 702, 704 can transition from a first, axially expanded configuration (like FIG. 5A) to a second, axially compressed configuration (like FIG. 5B) upon inflation and deflation of the balloon.

[0145] In some examples, e.g., any of the examples above, the first wire coil can comprise one, two, three, or any other suitable number of strands coupled together (e.g., at an end). In some examples, a second wire coil can comprise one, two, three, or any other suitable number of strands coupled together (e.g., at an end). In some examples, a device cancomprise any suitable number of wires having any suitable number of strands extending over at least a portion of a balloon.

[0146] Although the examples noted above describe inflatable balloons with both first and second wire coils (e.g., distal and proximal wire coils), it is understood that an inflatable balloon can comprise a distal wire coil, a proximal wire coil, or both a distal and proximal wire coil. Additionally, turn pitches and diameters of any wire coil described herein can vary and be specified to control the collapsing, radial force applied to the balloon during inflation. Moreover, a wire coil can extend helically over a greater or lesser extent of the balloon than the wire coils shown in FIGS. 4-7. For example, a first wire coil (e.g., 402, 502, 602, 702) can extend helically around a portion of the distal tapered portion 333 and not extend around the intermediate portion of the balloon. Similarly, a second wire coil (e.g., 404, 504, 604, 704) can extend helically around a portion of the proximal tapered portion 331 and not extend around the intermediate portion of the balloon. Although the examples illustrated herein describe a distal wire coil, a proximal wire coil, or both a distal and proximal wire coil, in any of the disclosed examples, a single coil can form one or more turns around each of the proximal leg of the balloon, the distal leg of the balloon, the intermediate portion of the balloon, and the tapered portions of the balloon. In this way, the collapsing, radial force applied to the balloon during inflation can be optimized to more completely and reliably collapse a deflated balloon into a compact, low-profile configuration for improved travel through a body.Delivery Techniques

[0147] 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 theapex 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-stemotomy or right parasternal mini -thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0148] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery' apparatus. The prosthetic valve and the distal end portion of the delivery' apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. 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.

[0149] 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.

[0150] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically ator near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.Sterilization

[0151] 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.

[0152] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation 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.Additional Examples of the Disclosed Technology

[0153] 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.

[0154] Example 1. A medical device comprising an inflatable balloon; and at least one wire coil extending helically around at least a portion of an outer surface of the balloon, wherein the at least one wire coil has a first configuration when the balloon is uninflated and can move from the first configuration to a second configuration when the balloon is inflated with an inflation fluid, and wherein the at least one wire coil can move from the second configuration back to the first configuration under its own resiliency when the inflation fluid is removed from the balloon, wherein the at least one wire coil is configured to apply a collapsing force to the balloon when the at least one wire coil moves from the second configuration to the first configuration.

[0155] Example 2. The device of any example herein, particularly example 1, wherein the at least one wire coil has a helical shape comprising a plurality of turns defining an inner lumen, and wherein a first portion of the inner lumen has a first diameter when the at least one wire coil is in the first configuration and a second diameter when the at least one wire coil is in the second configuration, wherein the second diameter is greater than the first diameter.

[0156] Example 3. The device of any example herein, particularly example 2, wherein a diameter of a second portion of the inner lumen is the same in the first and second configurations.

[0157] Example 4. The device of any example herein, particularly example 1, wherein the at least one wire coil has a helical shape comprising a plurality of turns disposed around a central longitudinal axis of the inflatable balloon, and wherein a first portion of the plurality of turns has a first pitch when the at least one wire coil is in the first configuration and a second pitch when the at least one wire coil is in the second configuration, wherein the second pitch is less than the first pitch.

[0158] Example 5. The device of any example herein, particularly example 4, wherein an end of the at least one wire coil is displaced along the central longitudinal axis from a first position to a second position when the at least one wire coil is moved to from the first configuration to the second configuration.

[0159] Example 6. The device of any example herein, particularly example 5, wherein the end of the at least one wire coil is displaced from the second position to the first position when the at least one wire coil is moved from the second configuration to the first configuration.

[0160] Example 7. The device of any example herein, particularly any one of examples 1-6, wherein an end portion of the at least one wire coil comprises a loop.

[0161] Example 8. The device of any example herein, particularly any one of examples 1-6, wherein the at least one wire coil comprises first and second strands connected to each other at a looped end portion, wherein the first and second strands extend helically around the outer surface of the balloon.

[0162] Example 9. The device of any example herein, particularly any one of examples 1-8, wherein the at least one wire coil extends around a proximal portion of the balloon.

[0163] Example 10. The device of any example herein, particularly any one of examples 1-8, wherein the at least one wire coil extends around a distal portion of the balloon.

[0164] Example 11. The device of any example herein, particularly any one of examples 1-8, wherein the at least one wire coil comprises a first wire coil that extends around a proximal portion of the balloon and a second wire coil that extends around a distal portion of the balloon.

[0165] Example 12. The device of any example herein, particularly any one of examples 1- 11, wherein the balloon comprises a central portion and the at least one wire coil does not extend around the central portion.

[0166] Example 13. The device of any example herein, particularly any one of examples 1- 12, wherein the at least one wire coil comprises a shape-memory material.

[0167] Example 14. The device of any example herein, particularly example 13, wherein the shape-memory material comprises Nitinol.

[0168] Example 15. A medical device comprising: an inflatable balloon; a first wire coil disposed around an outer surface of the inflatable balloon along a distal end portion of the balloon; and a second wire coil disposed around the outer surface of the inflatable balloon along a proximal end portion of the inflatable balloon, wherein the first and second wire coils have a radially expanded configuration and a radially collapsed configuration, and wherein the first and second wire coils move from the radially collapsed configuration to the radially expanded configuration when the inflatable balloon is inflated, and the first and second wire coils move back to the radially collapsed configuration under their own resiliency when the inflatable balloon is deflated to assist in collapsing the inflatable balloon.

[0169] Example 16. The device of any example herein, particularly example 15, wherein the first wire coil has a helical shape comprising a plurality of turns defining a first inner lumen, and wherein a proximal portion of the first inner lumen has a first diameter when the first wire coil is in the radially collapsed configuration and a second diameter, greater than the first diameter, when the first wire coil is in the radially expanded configuration.

[0170] Example 17. The device of any example herein, particularly example 16, wherein a diameter of a distal portion of the first inner lumen is the same when the first wire coil is in the radially collapsed and expanded configurations.

[0171] Example 18. The device of any example herein, particularly any one of examples 15-17, wherein the second wire coil has a helical shape comprising a plurality of turns defining a second inner lumen, and wherein a distal portion of the second inner lumen has a first diameter when the second wire coil is in the radially collapsed configuration and asecond diameter, greater than the first diameter, when the second wire coil is in the radially expanded configuration.

[0172] Example 19. The device of any example herein, particularly example 18, wherein a diameter of a proximal portion of the second inner lumen is the same when the second wire coil is in the radially collapsed and expanded configurations.

[0173] Example 20. The device of any example herein, particularly any one of examples 15-19, wherein a proximal end portion of the first wire coil and a distal end portion of the second wire coil comprise loops.

[0174] Example 21. The device of any example herein, particularly any one of examples 15-19, wherein each of the first and second wire coils comprise first and second strands that are connected to each other at a looped end portion and extend helically around the balloon.

[0175] Example 22. The device of any example herein, particularly any one of examples 15-21, wherein the first and second wire coils are made of Nitinol.

[0176] Example 23. A method comprising: receiving a medical device comprising a balloon and at least one wire coil extending helically around at least a portion of an outer surface of the balloon, wherein the at least one wire coil is in a first configuration; inflating the balloon from an uninflated state to an inflated state by introducing an inflation fluid into the balloon, which causes the at least one wire coil to move from the first configuration to a second configuration; and removing the inflation fluid from the balloon, which allows the at least one wire coil to move from the second configuration back to the first configuration under its own resiliency, thereby applying a collapsing force to the balloon to assist in collapsing the balloon.

[0177] Example 24. The method of any example herein, particularly example 23, wherein the at least one wire coil is made of Nitinol.

[0178] Example 25. The method of any example herein, particularly example 24, wherein introducing the inflation fluid into the balloon cools the at least one wire coil such that it becomes ductile or less elastic.

[0179] Example 26. The method of any example herein, particularly example 25, wherein introducing the inflation fluid into the balloon cools the at least one wire coil to a temperature below a transition temperature of the Nitinol.

[0180] Example 27. The method of any example herein, particularly any one of examples 25-26, wherein removing the inflation fluid from the balloon allows the at least one wire coil to warm to body temperature and becomes elastic or more elastic.

[0181] Example 28. The method of any example herein, particularly example 27, wherein the at least one wire coil is warmed to a temperature above a transition temperature of the Nitinol.

[0182] Example 29. The method of any example herein, particularly any one of examples 23-28, wherein the first configuration of the at least one wire coil is a radially collapsed configuration and the second configuration of the at least one wire coil is a radially expanded configuration.

[0183] Example 30. The method of any example herein, particularly any one of examples 23-28, wherein the first configuration of the at least one wire coil is an axially expanded configuration and the second configuration is an axially compressed configuration.

[0184] Example 31. The method of any example herein, particularly any one of examples 23-30, wherein the at least one wire coil comprises a first wire coil disposed around a proximal end portion of the balloon and a second wire coil disposed around a distal end portion of the balloon.

[0185] Example 32. A method comprising sterilizing the prosthetic heart valve, apparatus, wire coil, and / or assembly of any example.

[0186] Example 33. A prosthetic heart valve, apparatus, wire coil, device, and / or assembly of any one of examples 1-32, wherein the prosthetic heart valve, apparatus, wire coil, device, and / or assembly is sterilized.

[0187] Thus, specific examples of medical devices including inflatable balloons 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 devices and methods disclosed herein. The preceding detailed description illustrates examples and is not intended to limit the disclosure or the application and uses of the devices and methods disclosed herein. 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 disclosure. 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 isbroadly 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.

[0188] 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.

[0189] 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 wire coil can be combined with any one or more features of another wire coil. As another example, any one or more features of one delivery apparatus and / or medical device can be combined with any one or more features of another delivery apparatus and / or medical device.

[0190] 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.

[0191] 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

CLAIMS:

1. A medical device comprising:an inflatable balloon; andat least one wire coil extending helically around at least a portion of an outer surface of the balloon,wherein the at least one wire coil has a first configuration when the balloon is uninflated and can move from the first configuration to a second configuration when the balloon is inflated with an inflation fluid, andwherein the at least one wire coil can move from the second configuration back to the first configuration under its own resiliency when the inflation fluid is removed from the balloon, wherein the at least one wire coil is configured to apply a collapsing force to the balloon when the at least one wire coil moves from the second configuration to the first configuration.

2. The device of claim 1, wherein the at least one wire coil has a helical shape comprising a plurality of turns defining an inner lumen, and wherein a first portion of the inner lumen has a first diameter when the at least one wire coil is in the first configuration and a second diameter when the at least one wire coil is in the second configuration, wherein the second diameter is greater than the first diameter.

3. The device of claim 1, wherein the at least one wire coil has a helical shape comprising a plurality of turns disposed around a central longitudinal axis of the inflatable balloon, and wherein a first portion of the plurality of turns has a first pitch when the at least one wire coil is in the first configuration and a second pitch when the at least one wire coil is in the second configuration, wherein the second pitch is less than the first pitch.

4. The device of any one of claims 1-3, wherein the at least one wire coil comprises first and second strands connected to each other at a looped end portion, wherein the first and second strands extend helically around the outer surface of the balloon.

5. The device of any one of claims 1 -4, wherein the at least one wire coil extends around a proximal portion of the balloon.

6. The device of any one of claims 1-4, wherein the at least one wire coil extends around a distal portion of the balloon.

7. The device of any one of claims 1-6, wherein the balloon comprises a central portion and the at least one wire coil does not extend around the central portion.

8. The device of any one of claims 1-7, wherein the at least one wire coil comprises a shape-memory material.

9. A medical device comprising:an inflatable balloon;a first wire coil disposed around an outer surface of the inflatable balloon along a distal end portion of the balloon; anda second wire coil disposed around the outer surface of the inflatable balloon along a proximal end portion of the inflatable balloon, wherein the first and second wire coils have a radially expanded configuration and a radially collapsed configuration, andwherein the first and second wire coils move from the radially collapsed configuration to the radially expanded configuration when the inflatable balloon is inflated, and the first and second wire coils move back to the radially collapsed configuration under their own resiliency when the inflatable balloon is deflated to assist in collapsing the inflatable balloon.

10. The device of claim 9, wherein the first wire coil has a helical shape comprising a plurality of turns defining a first inner lumen, and wherein a proximal portion of the first inner lumen has a first diameter when the first wire coil is in the radially collapsed configuration and a second diameter, greater than the first diameter, when the first wire coil is in the radially expanded configuration.

11. The device of any one of claims 9-10, wherein the second wire coil has a helical shape comprising a plurality of turns defining a second inner lumen, and wherein a distal portion of the second inner lumen has a first diameter when the second wire coil is in the radially collapsed configuration and a second diameter, greater than the first diameter, when the second wire coil is in the radially expanded configuration.

12. The device of any one of claims 9-11, wherein a proximal end portion of the first wire coil and a distal end portion of the second wire coil comprise loops.

13. A method comprising:receiving a medical device comprising a balloon and at least one wire coil extending helically around at least a portion of an outer surface of the balloon, wherein the at least one wire coil is in a first configuration;inflating the balloon from an uninflated state to an inflated state by introducing an inflation fluid into the balloon, which causes the at least one wire coil to move from the first configuration to a second configuration; andremoving the inflation fluid from the balloon, which allows the at least one wire coil to move from the second configuration back to the first configuration under its own resiliency, thereby applying a collapsing force to the balloon to assist in collapsing the balloon.

14. The method of claim 13, wherein the at least one wire coil is made of Nitinol.

15. The method of claim 14, wherein introducing the inflation fluid into the balloon cools the at least one wire coil such that it becomes ductile or less elastic.

16. The method of claim 15, wherein introducing the inflation fluid into the balloon cools the at least one wire coil to a temperature below a transition temperature of the Nitinol.

17. The method of any of claims 15-16, wherein removing the inflation fluid from the balloon allows the at least one wire coil to warm to body temperature and becomes elastic or more elastic.

18. The method of claim 17, wherein the at least one wire coil is warmed to a temperature above a transition temperature of the Nitinol.

19. The method of any one of claims 13-18, wherein the first configuration of the at least one wire coil is a radially collapsed configuration and the second configuration of the at least one wire coil is a radially expanded configuration.

20. The method of any one of claims 13-18, wherein the first configuration of the at least one wire coil is an axially expanded configuration and the second configuration is an axially compressed configuration.

Images