Medical balloons with undulating wall portions

Abstract

Inflatable medical balloons comprising undulating wall portions are disclosed. A delivery apparatus for implanting a medical device in a subject comprises a shaft and an inflatable balloon coupled to a distal end portion of the shaft, where the inflatable balloon has an undulating wall portion. The undulating wall portion has a first length when the balloon is uninflated and a second length when the balloon is inflated, wherein the second length is greater than the first length. Also disclosed is a method of forming a catheter balloon comprising inserting a parison into a mold assembly and expanding the parison, where an inner mold surface has a plurality of ridges and valleys to form a wall of the catheter balloon with a plurality of undulations.

Description

MEDICAL BALLOONS WITH UNDULATING WALL PORTIONSCROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U. S. Provisional Application No. 63 / 734,295, filed December 16, 2024, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to medical balloons with undulating wall portions that lengthen when inflated.BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (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.

[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. Inflatable medical balloons can be used in someinstances to deploy or implant other implantable medical devices, such as for example, stents or grafts.SUMMARY

[0005] Inflatable medical balloons can be tightly folded and collapsed to a small profile for advancement through a subject’s vasculature to a treatment site. In some instances, it can be advantageous to maximize the length of the balloon when inflated to promote even radial expansion of the implantable medical device that is being expanded by the balloon. On the other hand, a medical balloon that is relatively short in its deflated state may be desirable to facilitate advancement of the balloon through curves in a subject’s vasculature, such as the aortic arch. Accordingly, a need exists for a medical balloon that can have a relatively short configuration for advancement through a body and a lengthened configuration along its longitudinal axis when inflated at an implantation site.

[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,” or “balloons”) used to deploy prosthetic implants, where the balloons are configured with at least one undulating wall portion that lengthens along a longitudinal axis during inflation. The disclosed devices and methods can, for example, lead to a balloon that has a compact, foreshortened state for easier travel through a body and an elongated state for improved deployment accuracy at an implantation site. 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 delivery apparatus for implanting a medical device in a subject can comprise a shaft and an inflatable balloon coupled to a distal end portion of the shaft. In addition to these components, a delivery apparatus can further comprise one or more of the components disclosed herein.

[0008] In some examples, the inflatable balloon can have at least one wall portion with an undulating wall comprising a plurality of undulations.

[0009] In some examples, the at least one wall portion can be a proximal end portion, a distal end portion, or both a proximal and distal end portion with an undulating wall comprising a plurality of undulations.

[0010] In some examples, the at least one wall portion comprising a plurality of undulations can extend from a proximal end portion to a distal end portion of the balloon.

[0011] In some examples, the at least one wall portion can be an intermediate portion with an undulating wall comprising a plurality of undulations.

[0012] In some examples, a proximal end portion of the balloon can have a first length when the balloon is uninflated and a second length when the balloon is inflated with an inflation fluid, wherein the second length is greater than the first length.

[0013] In some examples, a distal end portion of the balloon can have a first length when the balloon is uninflated and a second length when the balloon is inflated with an inflation fluid, wherein the second length is greater than the first length.

[0014] In some examples, the undulating wall portion can at least partially flatten when the balloon is inflated with the inflation fluid.

[0015] In some examples, the undulating walls of the proximal end portion, the distal end portion, or both proximal and distal end portions of the balloon can comprise a plurality of undulations comprising alternating, concentric ridges and valleys.

[0016] In some examples, one or more of the proximal end portion, the distal end portion, and the intermediate portion can comprise a plurality of undulations comprising alternating, concentric ridges and valleys.

[0017] In some examples, the undulating walls of the proximal end portion, the distal end portion, or both proximal and distal end portions of the balloon can comprise a plurality of undulations formed of a spiral groove that extends in a direction of a longitudinal axis of the balloon around a circumference of the balloon.

[0018] In some examples, one or more of the proximal end portion, the distal end portion, and the intermediate portion can comprise a plurality of undulations formed of a spiral groove that extends in a direction of a longitudinal axis of the balloon around a circumference of the balloon.

[0019] In some examples, the second lengths can be each at least 1.25 times greater than their respective first lengths.

[0020] In some examples, the proximal end portion, the distal end portion, or both proximal and distal end portions of the balloon can be conical and taper from an intermediate portion of the balloon toward respective ends of the balloon.

[0021] In some examples, the undulating walls of the proximal end portion, the distal end portion, or both proximal and distal end portions of the balloon can at least partially flatten when the balloon is inflated with the inflation fluid.

[0022] In some examples, the plurality of undulations can be configured with squared edges.

[0023] In some examples, the plurality of undulations can be configured with rounded edges.

[0024] In some examples, the plurality of undulations can have a pitch between adjacent undulations that varies along a length of the balloon.

[0025] In some examples, the plurality of undulations can have a pitch that is constant along a length of the balloon.

[0026] In some examples, a delivery apparatus for implanting a medical device in a subject comprises a shaft; and an inflatable balloon coupled to a distal end portion of the shaft, wherein the inflatable balloon has an undulating wall portion, and wherein the undulating wall portion has a first length when the balloon is uninflated and a second length when the balloon is inflated with an inflation fluid, wherein the second length is greater than the first length.

[0027] In some examples, a delivery apparatus comprises one or more of the components recited in Examples 1-8 and 34 below.

[0028] In some examples, an inflatable balloon for a medical device comprises a first configuration wherein at least one wall portion of the balloon comprises a plurality of undulations and extends a first length in a direction of a longitudinal axis of the balloon: and a second configuration wherein the plurality of undulations of the at least one wall portion are at least partially flattened and the at least one wall portion extends a second length in the direction of the longitudinal axis of the balloon, wherein the second length is greater than the first length.

[0029] In some examples, an inflatable balloon comprises one or more of the components recited in Examples 9-19 and 34 below.

[0030] A method can comprise receiving a medical device comprising a balloon and inflating the balloon from an uninflated state to an inflated state by introducing an inflation fluid into the balloon. In addition to these steps, a method can further comprise one or more of the steps disclosed herein.

[0031] In some examples, the balloon can comprise a proximal cone portion and a distal cone portion, wherein at least one of the proximal and distal cone portions can have an undulating wall portion in a first configuration.

[0032] In some examples, the act of inflating the balloon can cause the undulating wall portion to move from the first configuration to a second configuration in which the undulating wall portion is flatter than when it is in the first configuration.

[0033] In some examples, the undulating wall portion can have a first length in the first configuration and a second length in the second configuration, and wherein the second length can be greater than the first length.

[0034] In some examples, the method can further comprise removing the inflation fluid from the balloon which allows the balloon to return to the uninflated state such that the undulating wall portion reverts to the first configuration.

[0035] In some examples, a method comprises receiving a medical device comprising a balloon with a proximal cone portion and a distal cone portion, wherein at least one of the proximal and distal cone portions have an undulating wall portion in a first configuration; and inflating the balloon from an uninflated state to an inflated state by introducing an inflation fluid into the balloon, which causes the undulating wall portion to move from the first configuration to a second configuration in which the undulating wall portion is flatter than when it is in the first configuration.

[0036] In some examples, a method comprises one or more of the steps recited in Examples 20-22 below.

[0037] In some examples, a method of forming a catheter balloon can comprise inserting a parison into a mold assembly and expanding the parison. In addition to these steps, a method of forming a catheter balloon can further comprise one or more of the steps disclosed herein.

[0038] In some examples, the mold assembly can comprise an inner mold surface having at least a first portion with a first plurality of ridges and valleys.

[0039] In some examples, a first region of the expanded parison can contact the first portion of the inner mold surface having the first plurality of ridges and valleys to form a wall of the catheter balloon with a first plurality of undulations.

[0040] In some examples, the inner mold surface can comprise a second portion with a second plurality of ridges and valleys.

[0041] In some examples, a second region of the expanded parison can contact the second portion of the inner mold surface having the second plurality of ridges and valleys to form a wall of the catheter balloon with a second plurality of undulations.

[0042] In some examples, the first plurality of ridges and valleys, the second plurality of ridges and valleys, or both the first and second plurality of ridges and valleys can be configured with alternating, concentric ridges and valleys.

[0043] In some examples, the first plurality of ridges and valleys, the second plurality of ridges and valleys, or both the first and second plurality of ridges and valleys can be configured in a spiral.

[0044] In some examples, the first portion of the inner mold surface, the second portion of the inner mold surface, or both the first and second portions of the inner mold surface can be conical and taper from an intermediate portion of the mold assembly toward respective ends of the mold assembly.

[0045] In some examples, the act of expanding the parison can comprise blow-molding.

[0046] In some examples, a method of forming a catheter balloon can comprise forming a plurality of undulations in a portion of the balloon with a pleating machine.

[0047] In some examples, a method of forming a catheter balloon comprises inserting a parison into a mold assembly, wherein the mold assembly comprises an inner mold surface having at least a first portion with a first plurality of ridges and valleys; and expanding the parison, wherein a first region of the expanded parison contacts the first portion of the inner mold surface having the first plurality of ridges and valleys to form a wall of the catheter balloon with a first plurality of undulations.

[0048] In some examples, a method of forming a catheter balloon comprises one or more of the steps recited in Examples 23-33 below.

[0049] The method(s), techniques, processes, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on any suitable subject (e.g., a living subject (e.g., human, or other animal) or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, or simulator (for example, with body parts, heart, tissue, etc. being simulated), etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.

[0050] 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

[0051] FIG. 1 is a side view of a prosthetic heart valve, according to an example.

[0052] 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.

[0053] FIG. 3 is a side view of an inflatable balloon in a radially expanded, inflated state, according to an example.

[0054] FIG. 4 is a side view of an inflatable balloon shown in a radially expanded, inflated state with end portions comprising undulating walls in an extended state, according to an example.

[0055] FIG. 4A is a cross-section of a portion of the undulating wall of FIG. 4 taken along line 4A-4A of FIG. 4, wherein the wall portion is shown in a foreshortened state when the balloon is in an uninflated state, according to an example.

[0056] FIG. 4B is a cross-section of the wall portion of FIG. 4A when the inflatable balloon is in an inflated state.

[0057] FIG. 4C is a cross-section of another example of a portion of an undulating wall that can be incorporated in the balloon of FIG. 4, wherein the wall portion is shown in a foreshortened state when the inflatable balloon is in an uninflated state.

[0058] FIG. 4D is a cross-section of the wall portion of FIG. 4C when the inflatable balloon in an inflated state.

[0059] FIG. 5 is a perspective view of a portion of an inflatable balloon, according to an example, where a wall of the balloon comprises alternating, concentric ridges and valleys.

[0060] FIG. 6 is a perspective view of a portion of an inflatable balloon, according to an example, where a wall of the balloon comprises a spiral groove.

[0061] FIG. 7 is a side view of an inflatable balloon with cylindrical end portions comprising undulating walls, according to an example.

[0062] FIG. 8 is a side view of a mold assembly for forming a medical balloon, according to an example.

[0063] FIG. 9 is a perspective view of mold section of the mold assembly of FIG. 8.DETAILED DESCRIPTIONGeneral Considerations

[0064] 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.

[0065] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0066] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps not expressly referenced. Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. It is further noted that the claims can be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.

[0067] 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 theimplantation 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.

[0068] Reference throughout this specification to “an implementation” means that a particular feature, structure, or characteristic described in connection with the implementation is included in at least one implementation. Thus, appearances of the phrases “in an implementation” and “in some implementations” in various places throughout this specification are not necessarily all referring to the same implementation or a single exclusive implementation. Furthermore, the particular features, structures, or characteristics described herein may be combined in any suitable manner in one or more implementations.

[0069] The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any aspect described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects. Unless specifically stated otherwise, the term “some” refers to one or more.

[0070] It will be understood that the benefits and advantages described above can relate to one implementation or can relate to several implementations. Aspects described in connection with one implementation are intended to be able to be used with the other implementation. Any explanation in connection with one implementation applies to similar features of the other implementations, and elements of multiple implementations can be combined to form other implementations. The implementations are not limited to those that solve any or all of the stated problems or those that have any or all of the stated benefits and advantages.

[0071] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”Overview of the Disclosed Technology

[0072] Described herein are examples of balloons that can be used in various medical procedures. In some examples, the disclosed balloon catheters or balloons can comprise a delivery apparatus that can be used to navigate a subject’s vasculature to deliver an implantable, expandable medical device (for example, a prosthetic heart valve), tools, agents, or other therapy to a location within the body of a subject. Examples of procedures in which the catheters are useful include neurological, urological, gynecological, fertility (for example, in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal,transvesical, transrectal, and procedures including access in any body duct or cavity. Particular examples include placing implants, including stents, grafts, embolic coils, and the like; positioning imaging devices and / or components thereof, including ultrasound transducers; and positioning energy sources, for example, for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, and the like. In some examples, the disclosed balloon catheters can be used for performing procedures for opening or widening a blood vessel or heart valve annulus, such as an angioplasty or a valvuloplasty.

[0073] 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.

[0074] 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. As noted above, known balloons typically expand outwardly in a radial direction when inflated. A crimped, deflated balloon with a smaller radial and axial envelope can be more maneuverable during advancement through a body. In some instances, an inflated balloon with an extended axial envelope can provide more accurate deployment for a surrounding medical device. Therefore, a need exists for a balloon that has a reduced axial length along its longitudinal axis when uninflated and an extended axial length when inflated.

[0075] Described herein are inflatable medical balloons comprising one or more portions configured with undulations that lengthen during inflation. As used herein, a portion configured with undulations includes, among other things, portions that are wavy, pleated, and / or corrugated. 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 with an inflatable balloon. FIG. 3 shows a side view of an inflatable balloon in an inflated state, according to an example. FIG. 4 shows a side view of an inflatable balloon in an inflated state, according to an example, with endportions comprising extended, undulating walls. FIGS. 4A-4D illustrate examples of crosssections of a portion of the undulating wall of the balloon in FIG. 4 in uninflated and inflated states. FIGS. 5-7 show examples of balloons with undulating wall portions. FIGS. 8-9 illustrate a mold and a mold section for fabricating a medical balloon with undulating wall portions.Examples of the Disclosed Technology

[0076] 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.

[0077] FIG. 1 shows an exemplary 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.

[0078] Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries, and vessels of a subject. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in- valve procedure.

[0079] 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, thedisclosed 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.

[0080] 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.

[0081] 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.

[0082] 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 becrimped 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.

[0083] 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.

[0084] The inner skirt 116 and / or the outer skirt 118 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the skirts 116, 118 can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a 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 yams or fibers or randomly interlaced yams or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yams or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the skirts 116, 118 can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the skirts 116, 118 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the skirts 116, 118 can comprise natural tissue, such as pericardium (for example,bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0085] 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.

[0086] The delivery apparatus 200 in the illustrated example of FIG. 2 comprises a handle 202 and a steerable, outer shaft 204 extending distally from the handle 202. The delivery apparatus 200 can further comprise an intermediate shaft 206 (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.

[0087] 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.

[0088] 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.

[0089] The adaptor 212 can include a first port 238 configured to receive a guide wire 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.

[0090] 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.

[0091] 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.

[0092] 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.

[0093] 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 fluidpassageway from the annular space to inflate the balloon 218 and radially expand and deploy the prosthetic heart valve 250.

[0094] 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. Further details regarding the de-airing process is disclosed in WIPO Publication No. WO2022 / 046585, which is incorporated herein by reference.

[0095] 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.

[0096] 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.

[0097] 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). Furtherdetails on the delivery apparatus 200 can be found in PCT Publication No. WO2022 / 046585, which is incorporated by reference herein.

[0098] FIG. 3 is a side view of a catheter balloon 300, according to an example, where the balloon 300 is shown in a radially expanded, inflated state. 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 (also referred to herein as an “uninflated” state) and an inflated state about a central longitudinal axis 321. The main body 320 can comprise a proximal end 310, a distal end 312, 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.

[0099] 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.

[0100] 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 anddistal 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.

[0101] In some examples, the maximum diameters of the proximal tapered portion 331, the intermediate portion 336, and / or 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 and the 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. In some examples, the intermediate portion 336 can have a cylindrical shape when inflated, as shown. In some examples, the intermediate portion 336 can have a rounded, bulbous configuration and bow out when inflated, thus defining the maximum diameter in the radial direction.

[0102] The wall of the proximal tapered portion 331 can have an axial length 346 and the wall of the distal tapered portion 333 can have an axial length 348, where the axial lengths 346, 348 are measured along lines that are parallel to the outer surfaces of the proximal and distal tapered portions 331, 333. In some examples, the axial lengths 346, 348 can be the same and in some examples, the axial lengths 346, 348 can be different. The proximal tapered portion 331 can have an overall length 347 measured along the central axis 321 and the distal tapered portion 333 can have an overall length 349 measured along the central axis 321.

[0103] 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.

[0104] 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®, a polyester, such as polyethylene terephthalate (PET), polybutylene terephthalate, a thermoplastic elastomer copolyester (such as Hytrel®), or combinations thereof.

[0105] 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 or uninflated configuration.

[0106] Known medical balloons that are used for implanting prosthetic valves and other implants typically are made from compliant or semi-compliant materials which exhibit little, if any, stretchability when the balloon is inflated. Thus, in such examples, the proximal and distal tapered portions 331, 333 have substantially the same axial length when the balloon 300 is in an inflated state as when the balloon is an uninflated state. In other words, in some examples, the proximal and distal tapered portions 331, 333 do not significantly extend axially during inflation. In fact, the overall lengths 347, 349 of the proximal and distal tapered portions 331, 333 measured parallel to the central axis 321 may decrease when the balloon is inflated due to the fact that the proximal and distal tapered portions 331, 333 assume a wider flared shape and therefore decrease the overall length of the balloon when inflated. As described above, it can be advantageous for portions of the balloon 300 to axially extend or expand for improved positioning and accuracy during medical implant deployment. As such, portions of a balloon can be configured with undulating portions that axially contract into a shorter configuration for improved movement through a subject’s vasculature and / or an introducer sheath and axially extend during inflation for improved deployment.

[0107] FIG. 4 is a side view of a catheter balloon 400, according to an example, comprising a main body 420 disposed around a central longitudinal axis (also referred to herein as a “central axis” or a “longitudinal axis”) 421. The main body 420 can comprise a proximal end 410, a distal end 412, a proximal end portion 430, a distal end portion 432 distally disposed relative tothe proximal end portion 430, and an intermediate portion 436 extending therebetween. The proximal end portion 430 can comprise a proximal tapered portion 431 (which can also be referred to herein as a “proximal cone portion” or “proximal conical portion”) and a proximal leg 440 extending proximally from the proximal tapered portion 431. The distal end portion 432 can comprise a distal tapered portion 433 (which can also be referred to herein as a “distal cone portion” or “distal conical portion”) and a distal leg 442 extending distally from the distal tapered portion 433.

[0108] The proximal leg 440 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 442 can be configured to be coupled to a distal end component (for example, the nose cone 222 in FIG. 2). The intermediate portion 436, which in some examples can be referred to as a working portion of the catheter balloon 400, 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 440, the distal leg 442, the proximal tapered portion 431, the intermediate portion 436, and the distal tapered portion 433 can be integrally formed as a single component.

[0109] Each one of the proximal tapered portion 431, the intermediate portion 436, and the distal tapered portion 433 can define a maximum diameter in a radial direction. As shown in FIG. 4, the maximum diameters of the proximal tapered portion 431, the intermediate portion 436, and the distal tapered portion 433 are equal, such that the diameters of the proximal and distal tapered portions 431, 433 taper from the maximum diameter of the cylindrical intermediate portion 436 towards their respective ends of the catheter balloon 400.

[0110] In some examples, the maximum diameters of the proximal tapered portion 431, the intermediate portion 436, and the distal tapered portion 433 can be equal or substantially equal (for example, within 10%). In some examples, the intermediate portion 436 can have a cylindrical shape as shown or rounded, bulbous configuration and bow out when inflated, thus defining the maximum diameter in the radial direction. As shown in FIG. 4, the proximal tapered portion 431 and the distal tapered portion 433 each have a conical or frustoconical shape when the balloon is inflated. In some examples, as will be described further below in connectionwith FIG. 7, proximal and distal portions can have a substantially cylindrical shape when the balloon is inflated.

[0111] The proximal tapered portion 431 can have an axial length 446 and the distal tapered portion 433 can have an axial length 448, where the axial lengths 446, 448 are measured parallel to the outer surfaces of the tapered portions 431, 433. In some examples, the axial lengths 446.448 can be the same as each other and in some examples, the axial lengths 446, 448 can be different from each other. The proximal tapered portion 431 can have an overall length 447 measured along the central axis 421 and the distal tapered portion 433 can have an overall length 449 measured along the central axis 421.

[0112] In some examples, when the balloon 400 is fully inflated, the length 447 of the balloon 400 can be the same as the length 347 of the conventional balloon 300 and the length 449 of the balloon 400 can be the same as the length 349 of the conventional balloon 300.

[0113] In some examples, a length along a longitudinal axis from a proximal end to a distal end of an inflated balloon comprising wall undulations can be approximately the same as a length along the longitudinal axis of a conventional inflated balloon (i.e., without wall undulations), while the length along the longitudinal axis of the balloon with wall undulations can be reduced when in an uninflated state in relation to an inflated, conventional balloon for improved delivery through a subject’s vasculature.

[0114] As will be described in more detail below, the axial lengths 446, 448 can increase due to undulating walls forming the proximal and distal tapered portions 431, 433 when the balloon 400 is inflated. In some examples, for a 24-mm diameter balloon, in the inflated state, the length 447 can be 13 mm to 16 mm (14.7 mm being a specific example), the length 449 can be 10 mm to 13 mm (11.8 mm being a specific example), and the length of the intermediate portion 436 can be 27 mm to 33 mm (30 mm being a specific example).

[0115] In some examples, for a 26-mm diameter balloon, in the inflated state, the length 447 can be 14 mm to 18 mm (16.0 mm being a specific example), the length 449 can be 12 mm to 15 mm (13.4 mm being a specific example), and the length of the intermediate portion 436 can be 28 mm to 36 mm (32.2 mm being a specific example).

[0116] In some examples, for a 30-mm diameter balloon, in the inflated state, the length 447 can be 15 mm to 20 mm (17.5 mm being a specific example), the length 449 can be 13 mm to 18 mm (15.5 mm being a specific example), and the length of the intermediate portion 436 can be 32 mm to 40 mm (35.7 mm being a specific example).

[0117] In some examples, the lengths 447, 449 of the proximal and distal tapered portions 431, 433 in the uninflated state can be 50% of the values of the lengths provided above for the inflated state. In examples where the intermediate portion 436 does not have any undulations, the length of the intermediate portion can be the same or substantially the same in the uninflated and inflated states.

[0118] The main body 420 of the catheter balloon 400 can define an outer surface 450. The outer surface 450 can be a radially outwards-facing surface of the main body 420. The outer surface 450 can define different sections. For example, the outer surface 450 of the balloon 400 can be divided into a proximal section 452 (which is also referred to herein as a “proximal outer surface” and / or a “proximal outer surface section”), an intermediate section 454 (which is also referred to herein as an “intermediate outer surface” and / or an “intermediate outer surface section”), and a distal section 456 (which is also referred to herein as a “distal outer surface” and / or a “distal outer surface section”). The proximal section 452 of the outer surface 450 can be the outer surface of the proximal tapered portion 431. The intermediate section 454 of the outer surface 450 can be the outer surface of the intermediate portion 436. The distal section 456 of the outer surface 450 can be the outer surface of the distal tapered portion 433.

[0119] The balloon 400 can be made of a polymeric material, such as for example, a polyamide (PA) or co-polyamide, such as nylon (for example nylon 12), Pebax®, a polyester, such as polyethylene terephthalate (PET), polybutylene terephthalate, a thermoplastic elastomer copolyester (such as Hytrel®), or combinations thereof.

[0120] As described above, the balloon 400 can be inflated into an expanded or a partially expanded state by pushing an inflation fluid from a fluid source into the balloon 400. In some instances, the balloon 400 can be inflated to deploy a prosthetic implant. Unlike the balloon 300 shown in FIG. 3, the proximal and / or distal tapered (i.e., conical) portions 431, 433 can have undulating wall portions when in an uninflated state. FIGS. 4A-4D are cross-sections of a wallportion of a balloon taken in a plane that is parallel to and intersects the central axis 421 of the balloon.

[0121] In some examples, as shown in cross-section in FIG. 4A, the undulating wall portions of the balloon 400 can comprise a plurality of alternating peaks (also referred to herein as “ridges”) 460a, 461a and valleys 462a, 463a when in an uninflated state. The peaks 460a extend radially inward toward the central axis 421 and the peaks 461a extend radially outward away from the central axis 421. The valleys 462a are formed on an inner surface of the wall portion and the valleys 463a are formed on an outer surface of the wall portion. An overall height 464a of the undulating wall is defined as a distance from a peak 460a to an adjacent peak 461a (i.e., peak-to-peak) in a direction of a thickness t of the wall material. The overall height 464a can be the same along the proximal and distal conical portions 431, 433. In some examples, the height 464a can vary along the proximal conical portion 431, the distal conical portion 433, or both the proximal and distal conical portions 431. 433.

[0122] In some examples, the peaks 460a, 461a and valleys 462a, 463a can extend around the entire circumference of the proximal and distal conical portions 431, 433, forming complete annular peaks and valleys around the balloon. Adjacent peaks 460a can be separated by a distance (also referred to herein as a “pitch”) 466a in a direction perpendicular to the thickness t. In some examples, the pitch 466a can be the same along the proximal and distal conical portions 431, 433. In some examples, the pitch 466a can vary along the proximal conical portion 431, the distal conical portion 433, or both the proximal and distal conical portions 431, 433.

[0123] In some examples, the peaks 460a. 461a and valleys 462a, 463a can have squared-off edges or corners 468 as shown in FIG. 4A forming a square wave pattern in cross-section.

[0124] In some examples, the peaks 460a, 461a and valleys 462a, 463a can have a concentric pattern around the longitudinal axis 421 of the balloon 400 as seen, for example, on a cylindrical end portion in FIG. 5.

[0125] In some examples, the peaks 460a, 461a and valleys 462a, 463a can have a single spiral pattern as seen, for example, on a cylindrical end portion in FIG. 6.

[0126] Much like an extendable corrugated pipe or an accordion, the peaks 460a, 461a and valleys 462a. 463a can flatten out as seen in the cross-section of FIG. 4B due to internal pressurefrom the inflation fluid when the balloon 400 is inflated. The internal pressure acts to smooth (e.g., flatten) out the peaks 460a, 461a and valleys 462a, 463a as seen in FIG. 4B. In some examples, the peaks 460a, 461a and valleys 462a, 463a partially, but not completely, flatten when the balloon is fully inflated. As the peaks 460a, 461a and valleys 462a, 463a flatten out or become flatter, the walls of the proximal and distal conical portions 431, 433 can lengthen.Thus, the axial lengths 446, 448 of the undulating walls increase from a first value to a second, greater value when the balloon 400 is inflated, and the overall lengths 447, 449 of the proximal and distal conical portions 431, 433 increase, thereby increasing the overall length of the balloon when it is inflated. In some examples, the axial lengths 446, 448 of the proximal and distal conical portions 431, 433 in the inflated configuration are at least 1.25, at least 1.5, at least 1.75, or 2 times their respective lengths when in the uninflated configuration. In this way, the proximal and distal outer surfaces 452, 456 can have a smoother appearance as seen in FIG. 4. In some examples, when the inflation fluid is removed from the balloon 400. for example, after deployment of a prosthetic valve or other medical device, the undulating wall portions can revert back to the initial, pre-inflated state, thereby decreasing the overall length of the balloon.

[0127] In some examples, as described above, portions of the balloon 400 can be coupled to portions of a delivery apparatus. Accordingly, the delivery apparatus can be configured to accommodate lengthening of the wall portions of the balloon 400. For example, as described above, a proximal portion of the balloon 400 can be coupled to the intermediate shaft 206 or the inner shaft 208 of the delivery apparatus 200, and a distal portion of the balloon 400 can be coupled to the nose cone 222 of the delivery apparatus 200. As such, the intermediate shaft 206 and / or the inner shaft 208 of the delivery apparatus 200 in FIG. 2 can be constructed in a manner such that one or both of the inner shaft and the intermediate shaft can lengthen or foreshorten (in the axial direction) when the balloon 400 is inflated and deflated. For example, the inner shaft 208 can increase in length and / or the intermediate shaft 206 can decrease in length to accommodate an increase in balloon length when it is inflated. The inner shaft 208 can decrease in length and / or the intermediate shaft 206 can increase in length to accommodate a decrease in balloon length when it is deflated. In some examples, the inner shaft 208 can be adapted to slide axially relative to the intermediate shaft 206 to accommodate lengthening of the balloon.

[0128] In some examples, as seen in FIG. 4C, the undulating wall portions of the balloon can have peaks 460b, 461b and valleys 462b, 463b that can be rounded and have a wavy configuration with an overall peak-to-peak height 464b and a pitch 466b between adjacent peaks 460b. In some examples, the overall height 464b can be the same along the proximal and distal conical portions 431, 433. In some examples, height 464b can vary along the proximal conical portion 431, the distal conical portion 433, or both the proximal and distal conical portions 431, 433.

[0129] In some examples, the peaks 460b, 461b and valleys 462b, 463b can extend around the entire circumference of the proximal and distal conical portions 431, 433. In some examples, the pitch 466b can be the same along the proximal and distal conical portions 431, 433. In some examples, the pitch 466b can vary along the proximal conical portion 431, the distal conical portion 433, or both the proximal and distal conical portions 431, 433.

[0130] In some examples, the peaks 460b. 461b and valleys 462b, 463b can have a concentric pattern around the longitudinal axis 421 of the balloon 400 as seen, for example, on a cylindrical end portion in FIG. 5.

[0131] In some examples, the peaks 460b, 461b and valleys 462b, 463b can have a single spiral pattern as seen, for example, on a cylindrical end portion in FIG. 6.

[0132] In the same manner described above in connection with FIG. 4B, the peaks 460b, 461b and valleys 462b, 463b can flatten out as seen in the cross-section of FIG. 4D when the balloon 400 is inflated. As the peaks 460b, 461b and valleys 462b, 463b flatten out, the walls of the proximal and distal conical portions 431, 433 can lengthen in the direction of the longitudinal axis 421. In some examples, the axial lengths 446, 448 of the proximal and distal conical portions 431, 433 in the inflated configuration are at least 1.25 - 2 times their respective lengths when in the uninflated configuration.

[0133] In some examples, the peaks 460a, 461a, 460b, 461b and valleys 462a, 463a, 462b, 463b can extend along at least a portion of the proximal and distal conical portions 431, 433. In some examples, the peaks 460a, 461a, 460b, 461b and valleys 462a, 463a, 462b, 463b can extend along the entireties of the proximal and distal conical portions 431, 433. Although FIG. 4 shows undulating wall portions on both of the proximal and distal conical portions 431. 433 of theballoon 400, it is understood that, in some examples, the peaks 460a, 461a, 460b, 461b and valleys 462a. 463a, 462b, 463b can form at least a portion of one of the proximal or distal conical portions 431, 433 of the balloon 400. In some examples, the peaks 460a, 461a, 460b, 461b and valleys 462a, 463a, 462b, 463b can extend at least partially along the intermediate portion 436, in lieu of or in addition to peaks and valleys along the proximal conical portion 431 and / or the distal conical portion 433.

[0134] Additionally or alternatively, the heights 464a, 464b, the pitches 466a, 466b, and / or the patterns of the peaks 460a, 461a, 460b, 461b and valleys 462a, 463a, 462b, 463b can be selected to optimize the length of one or both of the proximal and distal conical portions 431, 433 when the balloon 400 is inflated.

[0135] In the examples of the FIGS. 4A-4D, the undulating wall portion is shown as being flattened when the balloon is fully inflated. In some examples, the undulating wall portion(s) of the balloon becomes flatter (e.g., the heights 464a, 464b decreases) when the balloon is inflated, but the undulating wall portion(s) do not completely flatten.

[0136] As described above, peaks and valleys can have a concentric pattern around a balloon. FIG. 5 is a perspective view of a cylindrical portion of an inflatable balloon 500 comprising an undulating wall portion with alternating, concentric ridges 504, 506 and valleys 508, 510, according to an example. The ridges 506 extend radially inward toward a central axis 514 of the balloon 500 and the ridges 504 extend radially outward away from the central axis 514. The valleys 510 are formed on an inner surface of the wall portion and the valleys 508 are formed on an outer surface of the wall portion. The ridges 504, 506 and valleys 508, 510 can extend around the entire circumference of the balloon 500, thus forming complete annular ridges and valleys. In some examples, the balloon 400 can include the undulating wall pattern shown in FIG. 5 along any portion of the balloon 400, including one or more of portions 440, 431. 436. 433, and / or 442.

[0137] In some examples, as described above, ridges and valleys can be formed in a spiral pattern around a balloon. FIG. 6 is a perspective view of a cylindrical portion of an inflatable balloon 600 comprising an undulating wall with ridges 604, 606 and valleys 608, 610 in single spiral pattern around the longitudinal axis 614, according to an example. That is, the valleys 608. 610 are comprised of a spiral groove disposed around the longitudinal axis 614. The ridge606 extends radially inward toward a central axis 614 of the balloon 600 and the ridge 604 extends radially outward away from the central axis 614. The valleys 610 are formed on an inner surface of the wall portion in regions between adjacent ridges 606. The valleys 608 are formed on an outer surface of the wall portion in regions between adjacent ridges 604. The ridges 604, 606 and valleys 608, 610 extend in the direction of the longitudinal axis 614 of the balloon around a circumference of the balloon, forming a spiral shape. In some examples, the balloon 400 can include the undulating, spiral wall pattern shown in FIG. 6 along any portion of the balloon 400, including one or more of portions 440, 431, 436, 433, and / or 442.

[0138] Although the balloons 300, 400 described above both comprise conical end portions, in some examples, medical balloons can have straight or cylindrical end portions and these cylindrical end portions can have undulating walls as described above in connection with FIGS.4-4D.

[0139] As seen in FIG. 7, a balloon 700 can comprise a main body 720 with a proximal end 710. a distal end 712, a proximal end portion 730, a distal end portion 732 distally disposed relative to the proximal end portion 730, and an intermediate portion 736 extending therebetween. The proximal and distal end portions 730, 732 have straight, cylindrical configurations disposed around a longitudinal axis 721 of the balloon, where the proximal end portion 730 extends between the intermediate portion 736 and the proximal end 710 and the distal end portion 732 extends between the intermediate portion 736 and the distal end 712. In the example shown in FIG. 7, the proximal and distal end portions 730, 732 can comprise undulating walls with peaks 760 and valleys 762 disposed in a concentric pattern around the longitudinal axis 721 of the balloon 700. In some examples, the peaks 760 and valleys 762 can be formed only on one of the proximal end portion 730 and the distal end portion 732. In some examples, the peaks 760 and the valleys 762 can be formed at least partially along the intermediate portion 736 in lieu of or in addition to the proximal end portion 730 and / or the distal end portion 732. In some examples, the peaks 760 and valleys 762 can be formed on the proximal conical portion 431, the distal conical portion 433 of the balloon 400, and / or the intermediate portion 436 of the balloon 400.

[0140] In some examples, the peaks 760 and valleys 762 can have a single spiral pattern as described, for example, in connection with FIG. 6.

[0141] As described above in connection with the balloon 400, the peaks 760 and valleys 762 can flatten out when the balloon 700 is inflated, due to internal pressure from the inflation fluid. As the peaks 760 and valleys 762 flatten out, the walls of the proximal and distal end portions 730, 732 can lengthen in the direction of the longitudinal axis 721.

[0142] To form medical balloons (such as the balloons 400. 700, or any other balloon described herein), in some examples, a parison can be positioned inside of a mold for blow molding the parison into a desired shape with undulations. FIG. 8 shows an example of a mold assembly 800 that can be used to form a medical balloon with undulating walls. The mold assembly 800 in the illustrated example comprises a proximal mold section 802, a distal mold section 804, and an intermediate mold section 806. The proximal mold section 802 can be used to form the proximal end portion of a balloon (e.g., proximal end portion 430); the distal mold section 804 can be used to form the distal end portion of the balloon (e.g., distal end portion 432); and the intermediate mold section 806 can be used to form the intermediate portion of the balloon (e.g.. intermediate portion 436).

[0143] FIG. 9 shows the inside of a mold section 802 or 804. In the example of FIG. 9, the mold section 802, 804 can comprise an inner mold surface 805 that has a conical profile and tapers from one end 808 of the mold section 802, 804 to another end 810 of the mold section 802, 804. At least a portion of the inner mold surface 805 can have a plurality of grooves 812 forming alternating peaks (also referred to herein as “ridges”) 816 and valleys 818.

[0144] In some examples, a parison can be positioned inside of an internal mold cavity, which can be defined by the inner surfaces of the mold sections 802, 804, 806. A fluid, such as air or an inert gas, can be injected into the parison to cause it to expand against the inner surfaces of the mold cavity. Heat can be applied to the parison during the molding process, such as by heating the fluid and / or applying heat to the mold assembly. As such, any portion of the parison in contact with the plurality of grooves can adopt the same contour as the inner mold surface 805, thus forming a plurality of corresponding wall undulations.

[0145] If the mold assembly includes two mold sections 802, 804 with ridges 816 and valleys 818, both end portions of the catheter balloon can be formed with a plurality of corresponding undulations. In some examples, only one of the mold sections 802 or 804 is shaped to formundulations, while the other mold sections have smooth inner surfaces to form balloon sections without undulations. In some examples, the intermediate mold section 806 can be formed with ridges 816 and valleys 818 to form undulations on the intermediate portion of the balloon.

[0146] In some examples, the plurality of grooves 812 can be formed as alternating ridges 816 and valleys 818 in a concentric pattern around a central longitudinal axis of the mold, thus forming a concentric, undulating pattern in the balloon wall when molded.

[0147] In some examples, the plurality of grooves 812 can be formed in a spiral pattern around a central longitudinal axis of the mold, thus forming a spiral undulating pattern in the balloon wall when molded.

[0148] In some examples, undulations in medical balloons (such as the balloons 400, 700, or any other balloon described herein) can be formed in a post-molding operation. For example, a medical balloon (such as the balloons 400, 700, or any other balloon described herein) can be molded without undulating wall portions using a conventional mold and then undulations in one or more sections of the balloon can be formed using a pleating machine or by manually folding the balloon.Delivery Techniques

[0149] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery' apparatus are inserted into a femoral artery' and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Additionally and / or alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Additionally and / or alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) isintroduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J- sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0150] 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 atria] 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.

[0151] 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.

[0152] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the- native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of theheart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0153] 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.Sterilization

[0154] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam.Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.Additional Examples of the Disclosed Technology

[0155] 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.

[0156] Example 1. A delivery apparatus for implanting a medical device in a subject, the delivery apparatus comprising: a shaft; and an inflatable balloon coupled to a distal end portion of the shaft, wherein the inflatable balloon has an undulating wall portion, and wherein the undulating wall portion has a first length when the balloon is uninflated and a second length when the balloon is inflated with an inflation fluid, wherein the second length is greater than the first length.

[0157] Example 2. The delivery apparatus of any example herein, particularly example 1, wherein the undulating wall portion comprises a plurality of undulations comprising a plurality of alternating peaks and valleys.

[0158] Example 3. The delivery apparatus of any example herein, particularly example 1, wherein the undulating wall portion comprises a plurality of undulations comprised of a spiral groove that extends in a direction of a longitudinal axis of the balloon around a circumference of the balloon.

[0159] Example 4. The delivery apparatus of any example herein, particularly any one of examples 1-3, wherein the second length is at least 1.25 times greater than the first length.

[0160] Example 5. The delivery apparatus of any example herein, particularly any one of examples 1-4, wherein the undulating wall portion at least partially flattens when the balloon is inflated with the inflation fluid.

[0161] Example 6. The delivery apparatus of any example herein, particularly any one of examples 1-5, wherein the balloon comprises a proximal conical portion, a distal conical portion, and an intermediate portion extending from the proximal conical portion to the distal conical portion, and at least one of the proximal conical portion, the distal conical portion, and the intermediate portion comprises the undulating wall portion.

[0162] Example 7. The delivery apparatus of any example herein, particularly example 6, wherein each of the proximal conical portion and the distal conical portion comprises a respective undulating wall portion.

[0163] Example 8. The delivery apparatus of any example herein, particularly example 6, wherein each of the proximal conical portion, the distal conical portion, and the intermediate portion comprises a respective undulating wall portion.

[0164] Example 9. An inflatable balloon for a medical device comprising: a first configuration wherein at least one wall portion of the balloon comprises a plurality of undulations and extends a first length in a direction of a longitudinal axis of the balloon; and a second configuration wherein the plurality of undulations of the at least one wall portion are at least partially flattened and the at least one wall portion extends a second length in the direction of the longitudinal axis of the balloon, wherein the second length is greater than the first length.

[0165] Example 10. The inflatable balloon of any example herein, particularly example 9, wherein the plurality of undulations are configured as alternating peaks and valleys.

[0166] Example 11. The inflatable balloon of any example herein, particularly example 9, wherein the plurality of undulations are configured as a spiral that extends in the direction of the longitudinal axis of the balloon around a circumference of the balloon.

[0167] Example 12. The inflatable balloon of any example herein, particularly any one of examples 9-11, wherein the plurality of undulations have squared edges.

[0168] Example 13. The inflatable balloon of any example herein, particularly any one of examples 9-11, wherein the plurality of undulations have rounded edges.

[0169] Example 14. The inflatable balloon of any example herein, particularly any one of examples 9-13, wherein the second length is at least 1.25 times greater than the first length.

[0170] Example 15. The inflatable balloon of any example herein, particularly any one of examples 9-14, wherein the plurality of undulations have a pitch between adjacent undulations that varies along the at least one wall portion.

[0171] Example 16. The inflatable balloon of any example herein, particularly any one of examples 9-14, wherein the plurality of undulations have a pitch between adjacent undulations that is constant along the at least one wall portion.

[0172] Example 17. The inflatable balloon of any example herein, particularly any one of examples 9-16, wherein the at least one wall portion is conical and tapers from an intermediate portion of the balloon toward an end of the balloon.

[0173] Example 18. The inflatable balloon of any example herein, particularly any one of examples 9-16, wherein the at least one wall portion extends from a distal end portion of the balloon to a proximal end portion of the balloon.

[0174] Example 19. The inflatable balloon of any example herein, particularly any one of examples 9-17, wherein the at least one wall portion comprises a first wall portion at a distal end portion of the balloon and a second wall portion at a proximal end portion of the balloon.

[0175] Example 20. A method comprising: receiving a medical device comprising a balloon having an undulating wall portion in a first configuration; and inflating the balloon from an uninflated state to an inflated state by introducing an inflation fluid into the balloon, whichcauses the undulating wall portion to move from the first configuration to a second configuration in which the undulating wall portion is flatter than when it is in the first configuration.

[0176] Example 21. The method of any example herein, particularly example 20, wherein the undulation wall portion has a first length in the first configuration and a second length in the second configuration, and wherein the second length is greater than the first length.

[0177] Example 22. The method of any example herein, particularly any one of examples 20-21, further comprising removing the inflation fluid from the balloon which allows the balloon to return to the uninflated state such that the undulating wall portion reverts to the first configuration.

[0178] Example 23. A method of forming a catheter balloon comprising: inserting a parison into a mold assembly, wherein the mold assembly comprises an inner mold surface having at least a first portion with a first plurality of ridges and valleys; and expanding the parison, wherein a first region of the expanded parison contacts the first portion of the inner mold surface having the first plurality of ridges and valleys to form a wall of the catheter balloon with a first plurality of undulations.

[0179] Example 24. The method of any example herein, particularly example 23, wherein the inner mold surface comprises a second portion with a second plurality of ridges and valleys.

[0180] Example 25. The method of any example herein, particularly example 24, wherein a second region of the expanded parison contacts the second portion of the inner mold surface having the second plurality of ridges and valleys to form a wall of the catheter balloon with a second plurality of undulations.

[0181] Example 26. The method of any example herein, particularly any one of examples 24-25, wherein the first plurality of ridges and valleys, the second plurality of ridges and valleys, or both the first and second plurality of ridges and valleys are configured with alternating, concentric ridges and valleys.

[0182] Example 27. The method of any example herein, particularly any one of examples 24-25, wherein the first plurality of ridges and valleys, the second plurality of ridges and valleys, or both the first and second plurality of ridges and valleys are configured in a spiral.

[0183] Example 28. The method of any example herein, particularly any one of examples 24-27, wherein the first portion of the inner mold surface, the second portion of the inner mold surface, or both the first and second portions of the inner mold surface are conical and taper from an intermediate portion of the mold assembly toward respective ends of the mold assembly.

[0184] Example 29. The method of any example herein, particularly any one of examples 23-28, wherein the act of expanding the parison comprises blow-molding.

[0185] Example 30. A method forming a catheter balloon, the method comprising: blow molding a balloon in a mold assembly to form a molded balloon; removing the molded balloon from the mold assembly; and forming undulations in a wall of the molded balloon.

[0186] Example 31. The method of any example herein, particularly example 29, wherein forming undulations in a wall of the molded balloon comprises forming the undulations with a pleating machine.

[0187] Example 32. The method of any example herein, particularly example 31, wherein forming undulations in a wall of the molded balloon comprises manually folding the wall.

[0188] Example 33. A method comprising sterilizing the apparatus, balloon, and / or assembly of any example.

[0189] Example 34. A medical balloon or delivery apparatus of any one of examples 1-33, wherein the medical balloon or delivery apparatus is sterilized.

[0190] 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 medical balloon can be combined with any one or more features of another medical balloon. As another example, any one or more features of one delivery apparatus can be combined with any one or more features of another delivery apparatus.

[0191] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

WE CLAIM:

1. A delivery apparatus for implanting a medical device in a subject, the delivery apparatus comprising:a shaft; andan inflatable balloon coupled to a distal end portion of the shaft, wherein the inflatable balloon has an undulating wall portion, andwherein the undulating wall portion has a first length when the balloon is uninflated and a second length when the balloon is inflated with an inflation fluid, wherein the second length is greater than the first length.

2. The delivery apparatus of claim 1, wherein the undulating wall portion comprises a plurality of undulations comprising a plurality of alternating peaks and valleys.

3. The delivery apparatus of claim 1, wherein the undulating wall portion comprises a plurality of undulations comprised of a spiral groove that extends in a direction of a longitudinal axis of the balloon around a circumference of the balloon.

4. The delivery apparatus of any one of claims 1-3, wherein the second length is at least 1.25 times greater than the first length.

5. The delivery apparatus of any one of claims 1-4, wherein the undulating wall portion at least partially flattens when the balloon is inflated with the inflation fluid.

6. The delivery apparatus of any one of claims 1-5, wherein the balloon comprises a proximal conical portion, a distal conical portion, and an intermediate portion extending from the proximal conical portion to the distal conical portion, and at least one of the proximal conical portion, the distal conical portion, and the intermediate portion comprises the undulating wall portion.

7. The delivery apparatus of claim 6, wherein each of the proximal conical portion and the distal conical portion comprises a respective undulating wall portion.

8. An inflatable balloon for a medical device comprising:a first configuration wherein at least one wall portion of the balloon comprises a plurality of undulations and extends a first length in a direction of a longitudinal axis of the balloon; and a second configuration wherein the plurality of undulations of the at least one wall portion are at least partially flattened and the at least one wall portion extends a second length in the direction of the longitudinal axis of the balloon, wherein the second length is greater than the first length.

9. The inflatable balloon of claim 8, wherein the plurality of undulations are configured as alternating peaks and valleys.

10. The inflatable balloon of any one of claims 8-9, wherein the plurality of undulations have squared edges.

11. The inflatable balloon of any one of claims 8-9, wherein the plurality of undulations have rounded edges.

12. The inflatable balloon of any one of claims 8-11, wherein the plurality of undulations have a pitch between adjacent undulations that varies along the at least one wall portion.

13. The inflatable balloon of any one of claims 8-11, wherein the plurality of undulations have a pitch between adjacent undulations that is constant along the at least one wall portion.

14. The inflatable balloon of any one of claims 8-13, wherein the at least one wall portion comprises a first wall portion at a distal end portion of the balloon and a second wall portion at a proximal end portion of the balloon.

15. A method comprising:receiving a medical device comprising a balloon having an undulating wall portion in a first configuration; andinflating the balloon from an uninflated state to an inflated state by introducing an inflation fluid into the balloon, which causes the undulating wall portion to move from the first configuration to a second configuration in which the undulating wall portion is flatter than when it is in the first configuration.

16. The method of claim 15, wherein the undulation wall portion has a first length in the first configuration and a second length in the second configuration, and wherein the second length is greater than the first length.

17. The method of any one of claims 15-16, further comprising removing the inflation fluid from the balloon which allows the balloon to return to the uninflated state such that the undulating wall portion reverts to the first configuration.

18. A method of forming a catheter balloon comprising:inserting a parison into a mold assembly, wherein the mold assembly comprises an inner mold surface having at least a first portion with a first plurality of ridges and valleys; and expanding the parison, wherein a first region of the expanded parison contacts the first portion of the inner mold surface having the first plurality of ridges and valleys to form a wall of the catheter balloon with a first plurality of undulations.

19. The method of claim 18, wherein the inner mold surface comprises a second portion with a second plurality of ridges and valleys.

20. The method of claim 19, wherein a second region of the expanded parison contacts the second portion of the inner mold surface having the second plurality of ridges and valleys to form a wall of the catheter balloon with a second plurality of undulations.

Images