Transcatheter medical apparatus including inflatable cutting balloons and methods of use

Abstract

Medical apparatus usable and / or for use in transcatheter procedures and associated methods for cutting a structure at a target site within a subject. The medical apparatus can include a handle having a shaft with a cutting balloon coupled to a distal end portion of the shaft for cutting of a portion of anatomy or a portion of a previously implanted device at the target site within the subject. The cutting balloon can include one or more blades. The blades can be disposed in an inverted portion of the balloon or on an exterior surface of the balloon. In some implementations, the medical apparatus can be a prosthetic heart valve delivery apparatus and can include a valve-expanding balloon coupled to the distal end portion of the shaft. In some implementations, the cutting balloon is distal of the valve-expanding balloon.

Description

THVDL-23707W001TRANSCATHETER MEDICAL APPARATUS INCLUDING INFLATABLE CUTTING BALLOONS AND METHODS OF USECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 709,279, filed October 18, 2024, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to inflatable balloons for medical devices, for example, apparatus and methods for cutting a structure at a target implantation site for implanting of a radially expandable prosthetic valves or other implantable devices within the target implantation site.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 subject’s vasculature (e.g., through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, 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 some examples, a prosthetic valve can be implanted within a native heart valve. In some examples, a prosthetic valve can be implanted within a previously implanted valve, which can also be referred to as a “valve -in-valve” procedure. In some examples, a valve-in-THVDL-23707W001 valve procedure is performed to replace the previously implanted valve without requiring a procedure to remove the previously implanted valve.SUMMARY

[0005] Described herein are medical apparatus usable and / or for use in transcatheter procedures and associated methods for manipulating a target site (for example, cutting a structure at the target site) within a subject utilizing the disclosed medical apparatus. The medical apparatus can include a handle having a shaft with a cutting balloon coupled to a distal end portion of the shaft for cutting of a portion of anatomy or a portion of a previously implanted device at the target site within the subject. The cutting balloon can include one or more blades disposed in a distal inverted portion.

[0006] In some implementations, the medical apparatus described herein can be a prosthetic heart valve delivery apparatus, and can be utilized for implanting prosthetic heart valves after cutting of a structure at the implantation site. In examples where the medical apparatus is a prosthetic valve delivery apparatus, the disclosed apparatus and methods can enable cutting native leaflets at a native heart valve or cutting leaflets of a previously implanted prosthetic valve, to improve seating and / or expansion of the prosthetic valve at the target implantation site by, for example, limiting obstruction by the native leaflets or the leaflets of the previously implanted prosthetic valve. In some implementations, the cutting balloon can be coupled to shaft of the delivery apparatus distal of a valve-expanding balloon configured to radially expand and deploy the prosthetic valve at the target implantation site. During use, the cutting balloon can be inflated to cut a structure at the target implantation site, the shaft can then be moved distally to position the valve -expanding balloon having the prosthetic valve mounted thereon within the target implantation site, and the valve-expanding balloon can then be inflated to deploy the prosthetic valve. 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 apparatus.

[0007] The techniques, methods, processes, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated”THVDL-23707W001(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.

[0008] In some implementations, a medical apparatus for insertion within a subject's body can comprise a handle, a shaft that extends from the handle, and a balloon mounted around a first portion of the shaft and having a longitudinal axis, wherein the balloon comprises an inflatable main body that is inflatable from a collapsed configuration to an inflated configuration, wherein the main body comprises a main body end portion having an outer surface facing the longitudinal axis, the balloon further comprising one or more blades attached to the main body end portion.

[0009] A medical apparatus can include a handle and a shaft coupled to the handle.

[0010] In some implementations, the medical apparatus can include a cutting balloon mounted on a distal end portion the shaft.

[0011] In some implementations, the cutting balloon comprises an inverted portion having one or more blades disposed therein.

[0012] In some implementations, the inverted portion is a proximal portion of the cutting balloon.

[0013] In some implementations, the inverted portion is a distal portion of the cutting balloon.

[0014] In some implementations, an inverted portion is a proximal portion of the cutting balloon, and a second inverted portion is a distal portion of the cutting balloon.

[0015] In some implementations, the inverted portion includes an outer wall and an inner wall.

[0016] In some implementations, in a collapsed configuration or state of the cutting balloon, the inner wall forms one or more pockets, each of the blades disposed within one of the pockets.

[0017] In some implementations, in a collapsed configuration or state of the cutting balloon, each of the blades is parallel and / or substantially parallel to a longitudinal axis of the cutting balloon.THVDL-23707W001

[0018] In some implementations, in a collapsed configuration or state of the cutting balloon, a cutting edge of each of the blades is oriented toward a longitudinal axis of the cutting balloon.

[0019] In some implementations, in an inflated configuration or state of the cutting balloon, the inverted portion has an inverted conical configuration.

[0020] In some implementations, in an inflated configuration or state of the cutting balloon, the blades extend radially outward from and are angled relative to a longitudinal axis of the cutting balloon.

[0021] In some implementations, in a partially inflated configuration or state of the cutting balloon, the inverted portion has an inverted conical configuration and the inner wall forms one or more pockets, each of the blades disposed within one of the pockets.

[0022] In some implementations, the distal portion of the balloon can include one or more cutouts formed through the outer and inner walls.

[0023] In some implementations, the cutouts are sized and shaped to receive and / or be fitted over a commissure of a valve structure.

[0024] In some implementations, one or more blades are disposed on an exterior surface of the balloon.

[0025] In some implementations, in an inflated configuration or state of the cutting balloon, a distal portion of the balloon has a conical shape and the blades are attached to the exterior surface along the distal portion.

[0026] In some implementations, a proximal edge of each blade has a greater length than a distal edge of the blade.

[0027] In some implementations, in an inflated configuration or state of the cutting balloon, a cutting edge of each blade is disposed at a greater angle relative to a longitudinal axis of the balloon than the exterior surface of the distal portion of the balloon.

[0028] In some implementations, the body of the balloon can have a cylindrical shape.

[0029] In some implementations, the body of the balloon has a shape of a three-pointed star in cross-section.

[0030] In some implementations, one or more blades can extend from a proximal end portion of the balloon to a distal end portion of the balloon.THVDL-23707W001

[0031] In some implementations, in an inflated configuration or state of the cutting balloon, the blades are parallel and / or about parallel (e.g., within 10 degrees of parallel, within 5 degrees of parallel) to a longitudinal axis of the balloon.

[0032] In some implementations, in a collapsed configuration or state of the cutting balloon, the balloon forms a plurality of folds and the blades are covered by the folds.

[0033] In some implementations, the shaft can be a shaft assembly including an inner shaft, a first intermediate shaft, and an outer shaft.

[0034] In some implementations, the cutting balloon can be in fluid communication with an annular space between the inner shaft and the first intermediate shaft for transmitting an inflation fluid to the cutting balloon.

[0035] In some implementations, the medical apparatus can be a delivery apparatus for a prosthetic implant.

[0036] In some implementations, the delivery apparatus can include an implant-expanding balloon mounted on a distal end portion the shaft.

[0037] In some implementations, the shaft assembly can include a second intermediate shaft and an annular space between the first intermediate shaft and the second intermediate shaft can be in communication with the implant-expanding balloon for transmitting an inflation fluid to the implant-expanding balloon.

[0038] In some implementations, the prosthetic implant can be a prosthetic heart valve radially compressed around a valve-mounting portion of the implant-expanding balloon.

[0039] In some implementations, the cutting balloon is distal of the implant-expanding balloon.

[0040] In some implementations, a prosthetic heart valve can comprise a frame and a valvular structure coupled to the frame. In addition to these components, a prosthetic heart valve can further comprise one or more of the components disclosed herein.

[0041] An assembly can comprise a prosthetic heart valve and a delivery apparatus having one or more of the foregoing features.

[0042] A method can include introducing a distal end portion of a medical apparatus into vasculature of a subject (e.g., a living subject, a simulation, etc.), the medical apparatus comprising a handle portion, an elongated shaft extending from the handle portion, the distal end portion comprising an inflatable cutting balloon mounted on the shaft, wherein theTHVDL-23707W001 inflatable cuting balloon is in a collapsed configuration and one or more blades are disposed within an inverted end portion of the balloon.

[0043] In some implementations, the method can include advancing, while the cutting balloon is in the collapsed configuration, the distal end portion of the delivery apparatus toward one or more of a native heart valve or a previously implanted prosthetic heart valve.

[0044] In some implementations, the method can include inflating the cutting balloon to increase an angle between the one or more blades and a longitudinal axis of the balloon in the inverted end portion.

[0045] In some implementations, the method can include cutting at least one of leaflets of the native heart valve or leaflets the previously implanted prosthetic heart valve with the one or more blades.

[0046] In some implementations, the method can include further advancing the distal end portion of the delivery apparatus until a radially compressed prosthetic heart valve mounted around a valve-expanding balloon is positioned within the one or more of the native heart valve or the previously implanted prosthetic heart valve.

[0047] In some implementations, the method can include inflating the valve -expanding balloon to radially expand the prosthetic heart valve within the one or more of the native heart valve or the previously implanted prosthetic heart valve.

[0048] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with body parts, heart, tissue, etc. being simulated).

[0049] In some implementations, a medical apparatus for insertion within a subject’s body, the medical apparatus comprises: a handle; a shaft that extends from the handle; and a balloon mounted around a distal end portion of the shaft and having a longitudinal axis, wherein the balloon comprises an inflatable main body that is inflatable from a collapsed configuration to an inflated configuration, wherein the main body comprises an inverted end portion having an outer surface facing the longitudinal axis, the balloon further comprising one or more blades attached to the outer surface within the inverted end portion.

[0050] In some implementations, a medical apparatus for insertion within a subject’s body, the medical apparatus comprises: a handle; a shaft assembly that extends from the handle; a first balloon mounted around a distal end portion of the shaft assembly and having a longitudinal axis; and a second balloon mounted around the distal end portion of the shaftTHVDL-23707W001 assembly, wherein the first balloon is distal of the second balloon, wherein the first balloon comprises an inflatable main body that is inflatable from a collapsed configuration to an inflated configuration and one or more blades attached to the main body within an inverted end portion of the main body.

[0051] In some implementations, a medical apparatus for insertion within a subject’s body, the medical apparatus comprises: a handle; a shaft assembly that extends from the handle; a first balloon mounted around a distal end portion of the shaft assembly and having a longitudinal axis; and a valve positioning component positioned on the distal end portion of the shaft assembly, wherein the first balloon is distal of the valve positioning component, wherein the first balloon comprises an inflatable main body that is inflatable from a collapsed configuration to an inflated configuration and one or more blades attached to the main body within an inverted end portion of the main body. The valve positioning component can comprise, for example, a balloon, one or more mechanical actuators that applies an expansion force to the prosthetic valve, one or more expansion members, and / or a portion of the shaft positioned at least partially within a sheath of the delivery apparatus so that the prosthetic valve can self-expand to its functional size.

[0052] In some implementations, an assembly comprises: a delivery apparatus comprising: a shaft assembly comprising a first shaft and a second shaft; a first balloon coupled to a distal portion of the first shaft and having a longitudinal axis; a second balloon coupled to the distal portion of the second shaft, wherein the first balloon is distal relative to the second balloon; and an implantable prosthetic heart valve that is radially collapsible to a radially collapsed configuration and radially expandable to a radially expanded configuration, wherein the prosthetic heart valve is mounted around the second balloon in the radially collapsed configuration and is radially expandable to the radially expanded configuration when the second balloon is inflated; wherein the first balloon comprises a main body that is inflatable from a collapsed configuration to an inflated configuration and one or more blades, wherein the main body comprises a proximal portion and a distal portion, wherein one or more blades are attached to the distal portion of the main body.

[0053] In some implementations, a method comprises: introducing a distal end portion of a medical apparatus into vasculature of a subject, the medical apparatus comprising a handle portion, an elongated shaft extending from the handle portion, the distal end portion comprising an inflatable cutting balloon mounted on the shaft, wherein the inflatable cuttingTHVDL-23707W001 balloon is in a collapsed configuration and one or more blades are disposed within an inverted end portion of the balloon; advancing, while the cutting balloon is in the collapsed configuration, the distal end portion of the medical apparatus toward one or more of a native heart valve or a previously implanted prosthetic heart valve; inflating the cutting balloon to increase an angle between the one or more blades and a longitudinal axis of the balloon in the inverted end portion; and cutting at least one of leaflets of the native heart valve or leaflets the previously implanted prosthetic heart valve with the one or more blades.

[0054] In some implementations, a medical apparatus, a delivery apparatus, a delivery assembly, and / or a method can comprise one or more of the components and / or steps recited in Examples 1-39 below.

[0055] 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.

[0056] All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain implementations herein is intended merely to better illuminate the devices and methods disclosed herein and does not pose a limitation on the scope of the disclosure otherwise claimed. No language in the specification should be constmed as indicating any non-claimed element essential to the practice of the disclosure.

[0057] Any of the above method(s) and any methods of using the systems, assemblies, apparatuses, devices, etc. herein can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, imaginary person, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can optionally comprise computerized and / or physical representations.

[0058] 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 simplifiedTHVDL-23707W001 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

[0059] FIG. 1 is a perspective view of a prosthetic heart valve, according to one example.

[0060] FIG. 2 is a side view of an example of a delivery apparatus configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site.

[0061] FIG. 3 is a side view of a distal portion of an example delivery apparatus including a cutting balloon and a valve-expanding balloon.

[0062] FIG. 4A is a side view of the cutting balloon of the delivery apparatus in FIG. 3, illustrating a collapsed configuration of the cutting balloon.

[0063] FIG. 4B is a cross-sectional view of the collapsed cutting balloon taken along the line 4B-4B shown in FIG. 4A

[0064] FIG. 5A is a side view of the cutting balloon of the delivery apparatus in FIG. 3, illustrating a partially inflated configuration of the cutting balloon.

[0065] FIG. 5B is a cross-section of a recess and a blade member of the cutting balloon in the partially inflated configuration taken along the line 5B-5B shown in FIG. 5A.

[0066] FIG. 5C is a distal end view of the cutting balloon in the partially inflated configuration of FIGS. 5A and 5B.

[0067] FIG. 6A is a side view of the of the cutting balloon of the delivery apparatus in FIG. 3, illustrating a fully inflated configuration of the cutting balloon.

[0068] FIG. 6B is a cross-section of a blade member of the cutting balloon in the fully inflated configuration taken along the line 6B-6B shown in FIG. 6 A.

[0069] FIG. 6C is a distal end view of the cutting balloon in the fully inflated configuration of FIGS. 6 A and 6B.

[0070] FIGS. 7A-7C are schematic illustrations of a cross-section of a native heart valve or a previously implanted prosthetic device showing cutting of leaflets and implantation of a prosthetic valve utilizing the delivery apparatus of FIG. 3.

[0071] FIG. 8A is a side view of an example cutting balloon that can be utilized with the delivery apparatus of FIG. 3 or other delivery apparatus.THVDL-23707W001

[0072] FIG. 8B is a perspective view of a portion of the cutting balloon of FIG. 8A and an example leaflet structure.

[0073] FIG. 9A is a side view of an example cutting balloon, which can be utilized with the delivery apparatus of FIG. 3 or other delivery apparatus, and an example leaflet structure.

[0074] FIG. 9B is a distal end view of the cutting balloon of FIG. 9A.

[0075] FIG. 9C is a side view of a portion of the cutting balloon of FIG. 9A showing an example blade.

[0076] FIGS. 10 A and 10B are cross-sectional views of example folded configurations for the cutting balloon of FIGS. 9A-9C.

[0077] FIG. 11 A is a distal end view of an example cutting balloon, which can be utilized with the delivery apparatus of FIG. 3 or other delivery apparatus.

[0078] FIG. 1 IB is a perspective view of the cutting balloon of FIG. 1 1 A and an example leaflet structure.

[0079] FIG. 12 is a distal end view of an example cutting balloon, which can be utilized with the delivery apparatus of FIG. 3 or other delivery apparatus.DETAILED DESCRIPTIONGeneral Considerations

[0080] 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 constmed 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.

[0081] 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 termsTHVDL-23707W001 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.

[0082] 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 tenninology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.

[0083] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (e.g., out of the subject’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (e.g., into the subject’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0084] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of the Disclosed Technology

[0085] Described herein are examples of a medical instrument or apparatus (in some examples referred to as a delivery catheter or delivery apparatus) that can be used to navigate a subject’s vasculature for transcatheter manipulation of a target site within a subject’s body, for example, a target implantation site for implantation of an implantable medical device. InTHVDL-23707W001 some implementations, the medical apparatus can be further configured to deliver an implantable, expandable medical device (for example, a prosthetic heart valve), tools, agents, or other therapy to a location within the subject’s body. Examples of procedures in which the exemplar medical apparatus may be 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. Some examples include placing implants, including stents, grafts, embolic coils, and the like; positioning imaging devices and / or components thereof, including ultrasound transducers; positioning energy sources, for example, for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, and the like; performing a valvuloplasty, angioplasty, or other remodeling procedures; and delivering agents, such as drugs, into a subject’s body.

[0086] The following description proceeds with reference to delivery apparatuses with inflatable balloons for implanting a prosthetic heart valve. However, it should be understood that the disclosed delivery apparatuses can be used to implant various other medical devices, such as any of those described above. Moreover, the example cutting balloons described herein can be incorporated into medical apparatus that are used to perform procedures that do not involve implanting an implantable medical device. For example, the example cutting balloons disclosed herein can be utilized in tissue traversals, treatment of clots and / or deposits in veins and arteries, such as, percutaneous transcatheter treatment of deep venous thrombosis, or other similar procedures.

[0087] As introduced above, in some implementations, a prosthetic heart valve can be implanted within a native heart valve in a transcatheter implantation procedure. In some implementations, it may be desirable to lacerate or cut a portion of the native anatomy (for example, a portion of the native leaflets, a calcified portion of a native annulus, etc.) to improve seating and / or implantation of the prosthetic heart valve within the native anatomy. In some implementations, a prosthetic heart valve can be implanted within a previously implanted heart valve in a transcatheter valve-in-valve procedure. In some implementations, the leaflets of the previously implanted prosthetic valve may obstruct and / or limit radial expansion of the replacement prosthetic valve. In such examples, it may be desirable to lacerate or cut the prosthetic leaflets of the previously implanted prosthetic valve to improveTHVDL-23707W001 seating and / or implantation of the prosthetic heart valve within the previously implanted prosthetic valve.

[0088] The delivery apparatus, assemblies, and methods disclosed herein can address one or more of the foregoing issues. In some implementations, a medical apparatus can include a shaft and a balloon coupled to a distal end portion of the shaft. The balloon can be a cutting balloon including a main body having a distal end portion with an inverted cone or frustoconical shape and one or more blade members (which may also be referred to herein as a blade or blades) disposed within the inverted cone that are configured cut or lacerate a structure (such as, for example, a portion of the native anatomy and / or a portion of a previously implanted device) at a target implantation site. In some implementations, the cutting balloon can be in a collapsed configuration for delivery to the implantation site. The blade members can each be retained within a pocket, a fold, and / or a recess within the balloon material in the collapsed configuration during delivery. Once positioned at the implantation site, the cutting balloon can be inflated from the collapsed configuration to an inflated configuration to expose the blade members and cut a structure at the implantation site. The cutting balloon can be deflated from the inflated configuration to the collapsed configuration for withdrawal of the distal end portion of the shaft through the subject’s vasculature.

[0089] In some implementations, the medical apparatus is a delivery apparatus that includes a second balloon (for example, a valve-expanding balloon) having a radially expandable medical device, such as a prosthetic heart valve, mounted therearound in a radially compressed state. In some implementations, the valve-expanding balloon is inflatable from a compressed configuration to an inflated configuration to cause radial expansion and deployment of the medical device at the target implantation site. In some implementations, the valve-deployment balloon can be mounted to the shaft of the medical apparatus and can be proximal relative to the cutting balloon. In some implementations, after cutting of the structure at the target implantation site is performed with the cutting balloon, the shaft can be moved distally to position the radially compressed prosthetic valve and the valve-expanding balloon within the target implantation site (for example, within an annulus of a native heart valve or within a previously implanted heart valve). The valve-expanding balloon can be inflated to deploy the prosthetic valve for implantation at the target implantation site. InTHVDL-23707W001 some implementations, the delivery apparatus including the cutting balloon and the second balloon can be referred to as a “tandem balloon delivery apparatus.”

[0090] In some implementations, it is contemplated that a valve-deployment balloon can be mounted to the shaft of the medical apparatus in any position (e.g., distal, proximal) relative to the cutting balloon.

[0091] The illustrations may include dimensions and graphical representation to better illustrate the referenced items shown, and are not considered limiting unless expressly stated as such.Examples of the Disclosed Technology

[0092] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves 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 valve can be expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0093] FIG. 1 shows an example prosthetic valve 10, according to one example. Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in 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.

[0094] In some implementations, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseasedTHVDL-23707W001 pulmonary valve, such as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated by reference herein. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020 / 247907, which is incorporated herein by reference. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0095] As shown in FIG. 1, the prosthetic valve 10 can have four main components: a stent or frame 12, a valvular structure 14, an inner skirt 16, and a perivalvular outer sealing member or outer skirt 18. The prosthetic valve 10 can have an inflow end portion 15, an intermediate portion 17, and an outflow end portion 19. The inner skirt 16 can be arranged on and / or coupled to an inner surface of the frame 12 while the outer skirt 18 can be arranged on and / or coupled to an outer surface of the frame 12.

[0096] The inner and / or outer skirts can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some implementations, the skirt can comprise a fabric having interlaced yams or fibers, such as in the form of a woven, braided, or knitted fabric. In some implementations, the fabric can have a plush nap or pile. Example fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some implementations, the skirt can comprise a fabric without interlaced yarns or fibers, such as felt or an electrospun fabric. Example materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some implementations, the skirt 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 implementations, the skirt can comprise a sponge material or foam, such as polyurethane foam. In some implementations, the skirt can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).THVDL-23707W001

[0097] The valvular structure 14 can comprise three leaflets 40, collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, although in other examples there can be greater or fewer number of leaflets (for example, one or more leaflets 40). The leaflets 40 can be secured to one another at their adjacent sides to form commissures 22 of the valvular structure 14. The lower edge of valvular structure 14 can have an undulating, curved scalloped shape and can be secured to the inner skirt 16 by sutures (not shown). In some implementations, the leaflets 40 can be formed of pericardial tissue (for example, bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118. This and all other extrinsic materials discussed herein, including publications, patent applications, and patents, are incorporated by reference in their entirety.

[0098] The frame 12 can be radially compressible (collapsible) and expandable (for example, expanded configuration shown in FIG. 1) and comprise a plurality of interconnected stmts 24. A plurality of apices 26 that are spaced circumferentially apart are formed at the inflow end portion 15 and the outflow end portion 19 of the frame 12 (only the apices 26 at the outflow end portion 19 are visible in FIG. 1). Each apex 26 is formed at a junction between two angled stmts 24 at either the inflow end portion 15 or the outflow end portion 19. FIG. 1 depicts a known frame design with apices 26 that form a U-shaped bend between the two angled stmts 24. In some implementations, an angle 30 between the two angled stmts 24, connected at the apex 26, can be in a range of 90 to 120 degrees.

[0099] The frame 12 can be formed with a plurality of circumferentially spaced slots, or commissure windows 20 that are adapted to mount the commissures 22 of the valvular structure 14 to the frame.

[0100] The frame 12 can be made of any of various suitable plastically -expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol) as known in the art. When constructed of a plastically -expandable material, the frame 12 (and thus the valve 10) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a subject by an inflatable balloon or equivalent expansion mechanism. When constmcted of a self-expandable material, the frame 12 (and thus the valve 10) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.THVDL-23707W001

[0101] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 12) include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some implementations, the frame 12 can comprise stainless steel. In some implementations, the frame 12 can comprise cobalt-chromium. In some implementations, the frame 12 can comprise nickel- cobalt-chromium. In some implementations, the frame 12 comprises a nickel-cobalt- chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R3OO35 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0102] In some implementations, an example delivery apparatus for implantation of a prosthetic device (for example, a prosthetic heart valve) in the heart can include an elongated shaft comprising a proximal end portion and a distal end portion, an inflatable balloon, and a valve mounting member. The balloon can be mounted on the distal end portion of the shaft. The valve mounting member can be disposed on the distal end portion of the shaft within the balloon and can be configured to facilitate frictional engagement between the prosthetic heart valve and the balloon when the prosthetic heart valve is mounted in a radially compressed state on the balloon and surrounding the mounting member. The mounting member can comprise at least one longitudinally extending fluid passageway though which an inflation fluid in the balloon can flow.

[0103] FIG. 2 shows an example of a delivery apparatus 100 that can be used to implant an expandable prosthetic heart valve (for example, prosthetic heart valve 10 of FIG. 1 or others of the prosthetic heart valves described herein). In some implementations, the delivery apparatus 100 is adapted for use in introducing a prosthetic valve into a heart.

[0104] The delivery apparatus 100 in the illustrated example of FIG. 2 is a balloon catheter comprising a handle 102 and a steerable, outer shaft 104 extending distally from the handle 102. The delivery apparatus 100 can further comprise an intermediate shaft 106 (which also may be referred to as a balloon shaft) that extends proximally from the handle 102 and distally from the handle 102, the portion extending distally from the handle 102 also extending coaxially through the outer shaft 104. Additionally, the delivery apparatus 100 can further comprise an inner shaft 108 extending distally from the handle 102 coaxially throughTHVDL-23707W001 the intermediate shaft 106 and the outer shaft 104 and proximally from the handle 102 coaxially through the intermediate shaft 106.

[0105] The outer shaft 104 and the intermediate shaft 106 can be configured to translate (for example, move) longitudinally, along a central longitudinal axis 120 of the delivery apparatus 100, relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a subject’s body.

[0106] The intermediate shaft 106 can include a proximal end portion 110 that extends proximally from a proximal end of the handle 102, to an adaptor 112. A rotatable knob 114 can be mounted on the proximal end portion 110 and can be configured to rotate the intermediate shaft 106 around the central longitudinal axis 120 and relative to the outer shaft 104.

[0107] The adaptor 112 can include a first port 138 configured to receive a guidewire therethrough and a second port 140 configured to receive fluid (for example, inflation fluid) from a fluid source (for example, a syringe). In some implementations, the second port 140 can be fluidly coupled to an inner lumen of the intermediate shaft 106 and can be configured for fluid communication with the fluid source 141. In some implementations, the second port 140 is in communication with a pressure sensor 142 (for example, a pressure gauge, a pressure transducer, a pressure transmitter, etc.). The pressure sensor 142 can, for example, be mounted on a syringe that is used as the fluid source 141.

[0108] The intermediate shaft 106 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 104 when a distal end of the outer shaft 104 is positioned away from an inflatable balloon 118 of the delivery apparatus 100. A distal end portion of the inner shaft 108 can extend distally beyond the distal end portion of the intermediate shaft 106.

[0109] The balloon 118 can be made of a pliable and / or elastic material, including, for example, any of various polyamides or co-polyamides, such as nylon (for example, nylon 12), Pebax®, Grilamid L25, or silicone and / or other materials or combinations thereof. The balloon 118 can be coupled to the distal end portion of the intermediate shaft 106.

[0110] In some implementations, a distal end of the balloon 118 can be coupled to a distal end of the delivery apparatus 100, such as to a nose cone 122 (as shown in FIGS. 2), or to an alternate component at the distal end of the delivery apparatus 100 (for example, a distal shoulder). An intermediate portion of the balloon 118 can overlay a valve mounting portionTHVDL-23707W001124 of a distal end portion of the delivery apparatus 100 and a distal end portion of the balloon 118 can overly a distal shoulder 126 of the delivery apparatus 100. The valve mounting portion 124 and the intermediate portion of the balloon 118 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG. 2, a prosthetic heart valve 150 (which can be one of the prosthetic valves described herein) can be mounted around the balloon 118, at the valve mounting portion 124 of the delivery apparatus 100.

[0111] The balloon shoulder assembly, including the distal shoulder 126, is configured to maintain the prosthetic heart valve 150 (or other medical device) at a fixed position on the balloon 118 during delivery through the subject's vasculature.

[0112] The outer shaft 104 can include a distal tip portion 128 mounted on its distal end. The outer shaft 104 and the intermediate shaft 106 can be translated axially relative to one another to position the distal tip portion 128 adjacent to a proximal end of the valve mounting portion 124, when the prosthetic valve 150 is mounted in the radially compressed state on the valve mounting portion 124 (as shown in FIG. 2) and during delivery of the prosthetic valve to the target implantation site. As such, the distal tip portion 128 can be configured to resist movement of the prosthetic valve 150 relative to the balloon 118 proximally, in the axial direction, relative to the balloon 118, when the distal tip portion 128 is arranged adjacent to a proximal side of the valve mounting portion 124.

[0113] An annular space can be defined between an outer surface of the inner shaft 108 and an inner surface of the intermediate shaft 106 and can be configured to receive fluid from the fluid source 141 via the second port 140 of the adaptor 112. The annular space can be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 108 and an inner surface of the balloon 118. As such, fluid from the fluid source 141 can flow to the fluid passageway from the annular space to inflate the balloon 118 and radially expand and deploy the prosthetic valve 150.

[0114] 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 100 to the target implantation site.

[0115] The handle 102 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 100. In the illustrated example, the handle 102 includes an adjustment member, such as the illustrated rotatable knob 160, which in turnTHVDL-23707W001 is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 102 through the outer shaft 104 and has a distal end portion affixed to the outer shaft 104 at or near the distal end of the outer shaft 104. Rotating the knob 160 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 100. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein.

[0116] The handle 102 can further include an adjustment mechanism 161 including an adjustment member, such as the illustrated rotatable knob 162, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 178. The adjustment mechanism 161 is configured to adjust the axial position of the intermediate shaft 106 relative to the outer shaft 104 (for example, for fine positioning at the implantation site). Further details on the delivery apparatus 100 can be found in WIPO Publication No. WO2022 / 046585, which is incorporated by reference herein.

[0117] Turning to FIG. 3, a distal portion of an example medical apparatus 200 is shown. In some implementations, the medical apparatus 200 is a delivery apparatus and includes one or more features of the delivery apparatus 100 discussed above. For example, the medical apparatus 200 can include an inner shaft 208 and an intermediate shaft 206, wherein an annular space within the intermediate shaft 206 is fluidly coupled to a balloon 218 and is configured to receive fluid from a fluid source for inflating the balloon 218. The annular space within the intermediate shaft 206 can be further configured for withdrawing fluid from the balloon 218 to transition the balloon 218 from an inflated state to a deflated state.Although not shown, the medical apparatus 200 can further include a handle, an outer shaft, and a nose cone similar (respectively) to the handle 102, the outer shaft 104, and the nose cone 122 shown in FIG. 2 and described above.

[0118] Different from the delivery apparatus 100, the balloon 218 is a proximal balloon and the medical apparatus 200 can additionally include a distal balloon 318 (that is distal of the balloon 218). The medical apparatus can also include an additional intermediate shaft 306 disposed between the inner shaft 208 and the intermediate shaft 206. An annular space formed between the inner shaft 208 and the intermediate shaft 306 can be fluidly coupled to the balloon 318 and can be configured to receive fluid from a fluid source for inflating the balloon 318. The annular space within the intermediate shaft 306 can be further configuredTHVDL-23707W001 for withdrawing fluid from the balloon 318 to transition the balloon 318 from an inflated state to a deflated state.

[0119] For illustrative purposes, the shafts 206, 208, 306 and the balloon 218 are shown in side view and the cutting balloon 318 is shown in cross-section. In some implementations, as shown in FIG. 3, the intermediate shaft 306 can be interior of the intermediate shaft 206, thereby forming the annular space that is fluidly coupled to the balloon 218 between the intermediate shaft 306 and the intermediate shaft 206. Also shown in shown in FIG. 3, a distal portion of the intermediate shaft 306 can extend through the balloon 218 to couple to a proximal portion 320 of the distal balloon 318. A distal portion of the inner shaft 208 can extend through the distal balloon 318.

[0120] In some implementations, similar to the balloon 118, the proximal balloon 218 can be configured for radially expanding a prosthetic device (for example, the prosthetic valve 10, other prosthetic valves or other expandable devices such as a stent) mounted therearound. In some implementations, the balloon 218 can be configured for dilation an anatomical structure, such as, for example, a valvuloplasty procedure. In some implementations, the distal balloon 318 can be a cutting balloon that includes one or more blade members that are configured to lacerate or cut a structure (such as, for example, an anatomical structure or a portion of a previously implanted device) at a target implantation site. In some implementations, the medical apparatus 200 including the proximal and distal balloons can be referred to as a “tandem balloon apparatus.” In some implementations, the cutting balloon 318 can be mounted proximal to the balloon 218. In some implementations, the medical apparatus 200 can include only the cutting balloon 318 coupled to the intermediate shaft 306. For example, the medical apparatus 200 can exclude the balloon 218 and the intermediate shaft 206.

[0121] As discussed above, the cutting balloon 318 can include a main body 322 having an inverted distal end portion 324 forming an inverted cone or frustoconical shape when the balloon is inflated. Along the distal end portion 324, the ballon 318 has an outer wall 324a and an inner wall 324b that extends inwardly from the outer wall 324a and forms an inverted cone when the balloon is inflated. A distal leg portion 327 of the balloon is connected to and extends from the inner end of the inner wall 324b. In some implementations, cutting balloon 318 can include a distal leg portion 327. In some implementations, distal leg portion 327 can be secured, such as with an adhesive, to the inner shaft 208. One or more blade members 326THVDL-23707W001(which can also be referred to as “blades”) can be disposed within the inverted cone, such as on the outer surface of the inner wall 324b.

[0122] The one or more blades 326 are configured to cut and / or lacerate a structure (such as, for example, a portion of the native anatomy and / or a portion of a previously implanted device) at a target implantation site. In some implementations, the cutting balloon 318 can be in a collapsed configuration for delivery to the implantation site, wherein the blade members 326 are retained within pockets, folds, and / or recesses within the balloon material. In some implementations, the pockets, folds, and / or recesses of the balloon can be made in part of a material different than other portions of the balloon. In some implementations, the pockets, folds, and / or recesses of the balloon can be made of a material different than other portions of the balloon. In some implementations, the pockets, folds, and / or recesses of the balloon can be made in part of a material more durable than other portions of the balloon. In some implementations, the pockets, folds, and / or recesses of the balloon can be made of a material more durable than other portions of the balloon. Once positioned at the implantation site, the cutting balloon can be inflated from the collapsed configuration to an inflated configuration to expose the blade members and cut a structure at the implantation site. The cutting balloon can be deflated from the inflated configuration to the collapsed configuration for withdrawal of the distal end portion the medical apparatus 200 through the subject’s vasculature.

[0123] In some implementations, a proximal end portion of the balloon can be inverted and can include the blades 326. In some implementations, both the proximal end portion and the distal end portion can be inverted and can includes the blades 326. The position of the blades 326 (along the distal and / or proximal end portions) can depend on the delivery approach used for accessing the target implantation site. For example, when accessing the aortic valve via a transfemoral delivery approach, it would be desirable to have the blades 326 positioned at the distal end portion of the balloon. On the other hand, when accessing the aortic valve via a transapical approach, it would be desirable to have the blades positioned at the proximal end portion of the balloon.

[0124] In some implementations, the balloon 318 may not have a distal leg portion 327, in which case the proximal most end of the inner wall 324b can be secured and sealed against the inner shaft 208.

[0125] Turning to FIGS. 4A-6B, example collapsed, partially inflated, and inflated configurations for the cutting balloon 318 are shown and described.THVDL-23707W001

[0126] For example, FIGS. 4A and 4B show the cutting balloon 318 in a collapsed configuration 328 (which can also be referred to as a “collapsed state”). FIG. 4A shows a side view of the collapsed balloon 318 and FIG. 4B shows a cross section of the collapsed balloon 318 taken along the line 4B-4B shown in FIG. 4A. As illustrated in FIG. 4A, in the collapsed configuration 328, the material of the main body 322 forms a plurality of folds 330. In some implementations, the plurality of folds 330 can be parallel or generally parallel to a longitudinal axis L-L of the collapsed balloon 318 and can be circumferentially spaced around the balloon 318. The inner wall 324b of the distal portion 324 of the collapsed balloon 318 can be spaced apart from the inner shaft 208 to form an annular space or gap between the inner wall 324b and an outer surface of the inner shaft 208. In some implementations, the inner wall 324b can contact the exterior surface of the shaft 208. FIGS. 4A-4B illustrate the balloon 318 without the distal leg portion 327; however, it should be understood that this feature can be included.

[0127] In some implementations, as shown in FIGS. 4B, the inner wall 324b can be formed with pockets or recess 334, each having one of the blade members 326 disposed therein. A cutting edge 336 of each of the blades 326 can be oriented toward the inner shaft 208. A base portion 338 (that is, a portion opposing the cutting edge 336) of each of the blades 326 can be attached to (for example, adhered to) an outer surface of the inner wall 324b within the respective pocket 334. When the balloon is uninflated, the blade members 326 can be completely recessed within the pockets 334 to avoid or minimize contact with the distal leg portion 327 and / or the inner shaft 208.

[0128] In some implementations, in lieu or in addition to the recesses 334, the inner wall 324b can be formed with a plurality of longitudinally extending folds or pleats (such as the locations on the inner wall 324b where the recesses 334 are located), and the blades 326 can be positioned within the folds so as to be recessed from the distal leg portion 327 and / or the inner shaft 208.

[0129] FIGS. 5A-5C show the cutting balloon 318 in a partially inflated configuration 340 (which can also be referred to as a “partially inflated state”). FIG. 5A shows a side view of the partially inflated balloon 318, FIG. 5B shows a cross section of a portion of the partially inflated balloon 318 (including one of the blades 326) taken along the line 5B-5B shown in FIG. 5A, and FIG. 5C shows a distal end of the partially inflated balloon 318. As can be seen therein, in the partially inflated state 340, a diameter of the main body 322 of the balloon 318THVDL-23707W001 can be increased relative to the collapsed state 328. In some implementations, the distal end portion 324 of the balloon 318 can have an inverted cone shape 342 (which can also be referred to as an “inverted cone configuration” or an “inverted conical configuration”). In some implementations, the distal end portion 324 of the balloon 318 can have an inverted frustoconical shape or configuration. The distal end portion 324 can also be referred to as an “inverted conical distal portion” - which can have either an inverted conical shape or an inverted frustoconical shape. It should be appreciated that an inverted distal end portion can have any suitable inverted size and / or shape.

[0130] In some implementations, an outer surface 344 of the inner wall 324b is disposed at an angle a relative to the longitudinal axis L-L. In some implementations, the angle a can be in a range of 40° to 70°. In some implementations, the angle a is in a range of 20° to 80° or any other suitable range. In some implementations, the balloon 318 can be molded and / or formed such that the angle a can correspond to or generally correspond to a shape of a valvular structure within a prosthetic heart valve and / or a shape of native leaflets of a native heart valve.

[0131] As shown in FIG. 5A, in the partially inflated configuration 340, the blades 326 can be recessed relative to the outer surface 344. In some implementations, as can be seen in FIG. 5B, the shape of the pockets 334 can be maintained in the partially inflated configuration 340 such that the cutting edges 336 of the blades 326 are recessed relative to the surface 344. In some implementations, the pockets 334 can have a shallower depth when the balloon is in the partially inflated configuration 340 (FIG. 5B) relative to when the balloon 318 is in the collapsed configuration 328 (FIG. 4B). In some implementations, the blade members 326 can extend radially outward relative to the shaft 208 and / or the central axis L-L of the balloon 318 when the balloon is partially inflated (FIG. 5C). In some implementations, the blade members 326 can be angled away from the shaft 208 and / or the central axis L-L in a proximal to distal direction. In some implementations, a first end of each blade member 326 is oriented toward the smallest or narrowest portion of the cone shape 342 and an opposing, second end of each blade member 326 is oriented toward the widest portion of the cone shape 342.

[0132] As can be seen in FIG. 5C, the balloon 318 can include three blade members 326. Tn some implementations, the balloon 318 can include fewer blade members 326 (for example,THVDL-23707W001 one or two blade members). In some implementations, the balloon 318 can include additional blade members 326 (for example, four, five, six, or more blade members).

[0133] It should be appreciated that the blades described herein can be any suitable shape. For example, one or more blades can have a rectangular sides and a triangular cross-section that tapers from a wider attachment point to a narrow blade edge. In some implementations, one or more blades may have a non-tapered cross-section. In some implementations, one or more blades can have a curved edge.

[0134] FIGS. 6A-6C show the cutting balloon 318 in an inflated configuration 346 (which can also be referred to as an “inflated state,” a “fully inflated configuration,” or a “fully inflated state”). FIG. 6A shows a side view of the fully inflated balloon 318, FIG. 6B shows a cross section of a portion of the fully inflated balloon 318 (including one of the blades 326) taken along the line 6B-6B shown in FIG. 6A, and FIG. 6C shows a distal end (bottom view) of the fully inflated balloon 318. As can be seen therein, in the inflated state 346, a diameter of the main body 322 of the balloon 318 can be the same or similar to the diameter of the main body 322 while the balloon is in the partially inflated state 340, and the distal end portion 324 of the balloon 318 can be in the inverted cone shape 342.

[0135] Different from the partially inflated state 340, in the fully inflated state 346, the inverted cone 342 can be further expanded such that interior surfaces of the pockets 334 are flush and / or closer to flush with the outer surface 344 of the inner wall 324b. In other words, the pockets or recesses 334 can be eliminated and / or reduced from the balloon 318 when in the fully inflated configuration 346 (FIG. 6C). As can be seen in FIGS. 6A and 6B, in the fully inflated configuration 346, blades 326 (and the cutting edges 336 thereof) can project outwardly from the outer surface 344 of the interior wall 324b.

[0136] FIGS. 7A-7C illustrate an example method of utilizing the medical apparatus 200. In some implementations, the distal end portion of the medical apparatus 200 can be navigated through vasculature 400 of a subject to a target implantation location or site 402, such as, for example, via one or more of the delivery techniques discussed below. In some implementations, the target implantation location 402 can be a native heart valve. In some implementations, the target implantation location 402 can be a previously implanted valve. During delivery to the target implantation site 402, each of the distal, cutting balloon 318 and the proximal, valve-expanding balloon 218 can be in a collapsed configuration. For example, the cutting balloon 318 can be in the collapsed configuration 328 shown in FIGS. 4A-4B.THVDL-23707W001

[0137] After delivery to a location adjacent the target site 402, the cutting balloon 318 can be transitioned from the collapsed state to the partially inflated state 340 (shown in FIGS. 5A- 5C), and then to the inflated state 346 (shown in FIGS. 6A-6C and FIGS. 7A-7B). In some example, as can be seen in FIGS. 7 A and 7B, the cutting balloon 318 can be fully inflated and then moved distally toward leaflets 404 of the target implantation location 402. In some implementations, the cutting balloon 318 can be partially inflated and then seated on the leaflets 404. After positioning on the leaflets 404, the balloon 318 can be transitioned to the fully inflated state. Each of the blades 326 can be aligned with a portion of one of the leaflets 404, such as, for example, a center portion of the leaflet. Further advancing the medical apparatus 200 in the distal direction so as to move or push the blades 326 against the leaflets 404 and / or allowing the leaflets to open and close against the blades 326 can be effective to cut or lacerate each of the leaflets 404. In some implementations, cutting of the leaflets 404 utilizing the cutting balloon 326 can facilitate access to the coronary arteries over techniques that cut a single leaflet, as two or more leaflets can be cut in a single procedure. For example, the cutting balloon 326 can enable access to the left and right coronary arteries by simultaneously cutting of each of leaflets respectively adjacent to the left and right coronary arteries.

[0138] In some implementations, after cutting of the leaflets 404, the distal end portion of the medical apparatus 200 can be moved further distally to position the collapsed balloon 218 and a radially compressed prosthetic valve, such as one of the valves 10, 150, within the native valve or the previously implanted prosthetic valve. The balloon 218 can then be inflated to cause radial expansion of the prosthetic valve 10, 150 and implantation of the prosthetic valve 10, 150 within the native valve or the previously implanted prosthetic valve, as shown in FIG. 7C. In such examples, the medical apparatus 200 can enable cutting of leaflets and implantation of a prosthetic heart valve in a single procedure. While the implementation described herein describes a balloon 218 configured to cause radial expansion of the prosthetic valve 10, it should be appreciated that any suitable expansion mechanism is contemplated.

[0139] In some implementations, cutting balloons usable and / or for use with the medical apparatus 200 or other medical apparatus can have other configurations. For example, FIGS. 8A and 8B illustrate an example cutting balloon 518 that is similar to the balloon 318, but includes one or more cutouts 502 in its outer and inner walls 524a, 524b at the distal endTHVDL-23707W001 portion 524 of the balloon. The cutouts 502 can form openings in an inverted cone shape 542 at the distal end portion 524. In some implementations, the cutting balloon 518 can be the same as the cutting balloon 318 except for the inclusion of the cutouts 502. The cutting balloon 518 can be used in place of the cutting balloon 318 in the delivery apparatus 200.

[0140] As can be seen in FIG. 8B, each of the cutouts 502 can be sized and shaped to receive and / or extend around a commissure 604 formed by two leaflets 602 of a leaflet structure 600. Although only one cutout 502 is shown in FIGS. 8A and 8B, the balloon 518 can include more, for example, two or three cutouts 502, for receiving the commissures 604 of the leaflet structure 600. Blades 526 of the balloon 518 can be attached to the inner wall 524b between the cutouts 502 within the inverted cone 542. Each blade 526 can be located circumferentially between two cutouts 502. In some implementations, the location of the blades between the cutouts enables the blades to contact a center portion of the respective leaflets 602 when the blades 526 and or other portions of the cutting balloon 518 are brought into contact with the leaflet structure 600.

[0141] Turning to FIGS. 9A-10B, an example cutting balloon 718 is shown. As shown in FIG. 9 A, the cutting balloon 718 can be coupled to the medical apparatus 200 distal of the valve-expanding balloon 218. The cutting balloon 718 can have one or more features that are similar to the cutting balloons 318, 518. Different from the cutting balloons 318, 518, in its inflated state 746, an outer wall 724a of the cutting balloon 718 can form a conical shape 742 at a distal end portion 724 of the balloon. A distal leg portion 727 can extend from the portion of the cone having the smallest diameter. Also different from the cutting balloons 318, 518, blades 726 of the balloon 718 can be attached to the outer wall 724a such that cutting edges of the blades 726 are oriented away from the inner shaft 208.

[0142] An example configuration and / or shape for the blades 726 is shown in FIG. 9C, which shows a base portion 738 attached to the outer wall 724a and a cutting edge 736 opposing the base portion 738. A proximal end edge 750 of the blade 726 can be longer than its distal end edge 752 so that, when in the inflated configuration 746, an angle a between a longitudinal axis L-L of the balloon and the cutting edge 736 is greater than an angle b between the longitudinal axis L-L and the outer wall 724a. The greater angle of the cutting edge 736 can improve contact between the blades 726 and leaflets 602 of the valve structure 600 as the cutting balloon 718 is pushed distally. In some implementations, the cutting edge 736 of the blades 726 can be disposed at a same angle relative to the longitudinal axis L-L asTHVDL-23707W001 the outer wall 724a. In some implementations, the cutting edge 736 of the blades 726 can be disposed at a smaller angle relative to the longitudinal axis L-L than the outer wall 724a (for example, the proximal edge of the blade can be longer than the distal edge).

[0143] For illustrating their respective sizes, both of the cutting balloon 718 and the valveexpanding balloon 218 (having the prosthetic heart valve 10 disposed therearound) are shown in an expanded, inflated state. When inflated, the cutting balloon 718 can have a smaller maximum diameter than the inflated valve-expanding balloon 218. In some implementations, a maximum diameter of the cutting balloon 718 can be at least 10%, at least 15%, at least 20%, at least 25%, etc. less than the maximum diameter of the valve-expanding balloon 218. In some implementations, for implantation of a 29 mm diameter prosthetic heart valve, the cutting balloon can have a maximum diameter of in a range of 17 mm to 23 mm, 18 mm to 22 mm, 18 mm to 21 mm, 19 mm to 21 mm, such as a 20 mm diameter. In some implementations, the smaller diameter of the cutting balloon 718 can avoid interference with the commissures 604 of the leaflet structure 600 during distal advancement of the cutting balloon 718 and improve cutting of the leaflets 602. In some implementations, the smaller diameter of the cutting balloon 718 can enable insertion of the balloon 718 further into the valve structure 600 to improve cutting of the leaflets 602.

[0144] FIG. 10A shows an example collapsed state 728 for the cutting balloon 718. FIG. 10B shows an example partially unfolded or partially inflated state 740 for the cutting balloon 718. As can be seen therein, the balloon 718 can be folded to form a plurality of folds 730.In some implementations, each fold 730 is pleated axially and then wrapped circumferentially over an adjacent fold 730. Each blade 726 can be positioned in the space between two adjacent folds 730 such that it is covered by the folds 730 to limit contact between the cutting edge of the blade and the balloon material. As the balloon 718 is inflated to the partially inflated state 740, the folds 730 unfurl and the blades 726 can be exposed. In lieu of or in addition to blades 726 on the conical distal end portion 724 of the balloon 718, one or more blades 726 can be positioned along the cylindrical intermediate portion of the balloon 718 and / or the conical proximal end portion of the balloon 718, which blades can be positioned between the folds when the balloon is uninflated.

[0145] FIGS. 11 A and 11 B show an example cutting balloon 818. The cutting balloon 818 can have one or more features that are similar to the cutting balloons 318, 518, 718. In someTHVDL-23707W001 implementations, the cutting balloon 818 can be used in place of the cutting balloon 318 in the delivery apparatus 200.

[0146] Different from the cutting balloons 318, 518, 718, a main body 822 the balloon 818 has a cylindrical shape. In some implementations, the main body 822 of the cutting balloon 818 can have a consistent diameter from its proximal end portion 820 to its distal end portion 824. Blades 826 can be attached to an outer wall 824a of the balloon 818 and can extend from the proximal end portion 820 to the distal end portion 824. In some implementations, cutting edges of the blades 826 can be parallel to a longitudinal axis L-L of the balloon 818. In some implementations, the blades 826 can have a configuration similar to the blades 726 and the cutting edges of the blades 826 can be disposed at an angle relative to the longitudinal axis L-L. When the balloon 818 is uninflated, the balloon can be folded as shown in FIG.10A such that the blades 826 are positioned between the folds.

[0147] FIG. 12 shows an example cutting balloon 918 having a similar structure to the cutting balloon 818 except that the main body 922 has a three-pointed star configuration rather than a cylindrical configuration. Blades 926 can be positioned at the points of the star formed by the radially projecting triangular sections of the balloon. In some implementations, the cutting balloon 918 can be used in place of the cutting balloon 318 in the delivery apparatus 200.

[0148] In some implementations, a maximum diameter of the balloon 818, 918 in an inflated state 846, 946 can be sized to enable insertion of the cutting balloon 818, 918 between the leaflets 602 (that is, into an interior space of the valvular structure 600). After insertion into the interior space of the valvular structure 600, cyclic opening and closing of the leaflets against the cutting edges of the blades 826, 926 can cause abrasion and cutting of the leaflets 602. Similar to the balloon 718, the balloons 818, 918 can have a maximum diameter that is smaller than that of the balloon 218 in their inflated states, such as at least 20% less than the maximum inflated diameter of the balloon 218.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 prostheticTHVDL-23707W001 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) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[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 atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Additionally and / or alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[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.THVDL-23707W001

[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 the heart) 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 now or in the future.

[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 subjects, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation usable and / or for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals usable and / or for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.

[0155] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with the body parts, tissue, etc. being simulated), etc.Additional Examples of the Disclosed Technology

[0156] 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 inTHVDL-23707W001 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.

[0157] Example 1. A medical apparatus for insertion within a subject’s body, the medical apparatus comprising: a handle; a shaft that extends from the handle; and a balloon mounted around a distal end portion of the shaft and having a longitudinal axis, wherein the balloon comprises an inflatable main body that is inflatable from a collapsed configuration to an inflated configuration, wherein the main body comprises an inverted end portion having an outer surface facing the longitudinal axis, the balloon further comprising one or more blades attached to the outer surface within the inverted end portion.

[0158] Example 2. The medical apparatus of claim 1, wherein the inverted end portion is a distal end portion of the main body.

[0159] Example 3. The medical apparatus of either claim 1 or claim 2, wherein the inverted end portion forms an inverted cone when the main body is inflated.

[0160] Example 4. The medical apparatus of claim 3, wherein, in the inflated configuration, a first end of each of the one or more blades is oriented toward a smaller end of the inverted cone and a second end of the blade is oriented toward a larger end of the inverted cone.

[0161] Example 5. The medical apparatus of any of claims 1-4, wherein the one or more blades comprise a plurality of blades, wherein the plurality of blades extend radially relative to the longitudinal axis of the main body of the balloon and angle away from the longitudinal axis.

[0162] Example 6. The medical apparatus of any of claims 1-5, wherein, in the collapsed configuration, each the one or more blades is parallel to the longitudinal axis.

[0163] Example 7. The medical apparatus of any of claims 1-6, wherein, in the collapsed configuration, each the one or more blades is disposed within a pocket formed in an inner wall of the inverted end portion of the main body of the balloon and a cutting edge of the blade is recessed relative to the outer surface of the balloon within the inverted end portion.

[0164] Example 8. The medical apparatus of claim 7, wherein the inflated configuration is a fully inflated configuration, and wherein the inflatable main body is inflatable from the collapsed configuration to a partially inflated configuration, and from the partially inflated configuration to the fully inflated configuration, wherein, in the partially inflatedTHVDL-23707W001 configuration, each the one or more blades is angled away from the longitudinal axis and is disposed within the respective pocket.

[0165] Example 9. The medical apparatus of any of claims 1-8, wherein, in the inflated configuration, the balloon is configured for cutting one or more of an anatomical structure or a portion of a previously implanted prosthetic valve within a subject.

[0166] Example 10. The medical apparatus of any of claims 1-9, wherein the balloon is a first balloon, and the medical apparatus further comprises a second balloon mounted around the distal end portion of the shaft.

[0167] Example 11. The medical apparatus of claim 10, further comprising an implantable prosthetic heart valve that is radially collapsible to a radially collapsed configuration and radially expandable to a radially expanded configuration, wherein the prosthetic heart valve is mounted around the second balloon in the radially collapsed configuration and is radially expandable to the radially expanded configuration when the second balloon is inflated.

[0168] Example 12. The medical apparatus of any of claims 1-11, wherein the one or more blades comprise three blades.

[0169] Example 13. A medical apparatus for insertion within a subject’s body, the medical apparatus comprising: a handle; a shaft assembly that extends from the handle; a first balloon mounted around a distal end portion of the shaft assembly and having a longitudinal axis; and a second balloon mounted around the distal end portion of the shaft assembly, wherein the first balloon is distal of the second balloon, wherein the first balloon comprises an inflatable main body that is inflatable from a collapsed configuration to an inflated configuration and one or more blades attached to the main body within an inverted end portion of the main body.

[0170] Example 14. The medical apparatus of claim 13, wherein the inverted end portion is a distal end portion of the main body.

[0171] Example 15. The medical apparatus of either claim 13 or claim 14, wherein the inverted end portion forms an inverted cone when the main body is inflated.

[0172] Example 16. The medical apparatus of any of claims 13-15, wherein the one or more blades comprise a plurality of blades, wherein the plurality of blades extend radially relative to the longitudinal axis of the main body of the balloon and angle away from the longitudinal axis.THVDL-23707W001

[0173] Example 17. The medical apparatus of claim 16, wherein the plurality of blades is three blades.

[0174] Example 18. The medical apparatus of any of claims 13-17, wherein, in the collapsed configuration, each the one or more blades is parallel to the longitudinal axis.

[0175] Example 19. The medical apparatus of any of claims 13-18, wherein, in the collapsed configuration, each the one or more blades is disposed within a pocket formed in an inner wall of the inverted end portion of the main body of the balloon and a cutting edge of each of the one or more blades is oriented towards the longitudinal axis.

[0176] Example 20. The medical apparatus of any of claims 13-19, wherein the second balloon is configured to have an implantable prosthetic heart valve mounted thereon in a radially collapsed configuration, and wherein the second balloon is inflatable to radially expand the prosthetic heart valve from the radially collapsed configuration to a radially expanded configuration.

[0177] Example 21. An assembly comprising: a delivery apparatus comprising: a shaft assembly comprising a first shaft and a second shaft; a first balloon coupled to a distal portion of the first shaft and having a longitudinal axis; a second balloon coupled to the distal portion of the second shaft, wherein the first balloon is distal relative to the second balloon; and an implantable prosthetic heart valve that is radially collapsible to a radially collapsed configuration and radially expandable to a radially expanded configuration, wherein the prosthetic heart valve is mounted around the second balloon in the radially collapsed configuration and is radially expandable to the radially expanded configuration when the second balloon is inflated; wherein the first balloon comprises a main body that is inflatable from a collapsed configuration to an inflated configuration and one or more blades, wherein the main body comprises a proximal portion and a distal portion, wherein one or more blades are attached to the distal portion of the main body.

[0178] Example 22. The assembly of claim 21, wherein, in the inflated configuration of the main body of the first balloon, the one or more blades are angled away from the longitudinal axis of the first balloon in a proximal to distal direction and are configured for cutting a structure at a target implantation site

[0179] Example 23. The assembly of either claim 21 or claim 22, wherein the distal portion of the main body comprises an inverted end portion, and wherein, in the inflatedTHVDL-23707W001 configuration of the main body of the first balloon, the inverted end portion forms an inverted cone.

[0180] Example 24. The assembly of any of claims 21-23, wherein in the collapsed configuration of the main body of the first balloon, each the one or more blades is parallel to the longitudinal axis.

[0181] Example 25. The assembly of any of claims 21-24, wherein, in the collapsed configuration of the main body of the first balloon, each of the one or more blades is disposed within a pocket formed in an inner wall of the distal portion of the main body of the balloon and a cutting edge of each of the one or more blades is oriented towards the longitudinal axis.

[0182] Example 26. A method comprising: introducing a distal end portion of a medical apparatus into vasculature of a subject, the medical apparatus comprising a handle portion, an elongated shaft extending from the handle portion, the distal end portion comprising an inflatable cutting balloon mounted on the shaft, wherein the inflatable cutting balloon is in a collapsed configuration and one or more blades are disposed within an inverted end portion of the balloon; advancing, while the cutting balloon is in the collapsed configuration, the distal end portion of the medical apparatus toward one or more of a native heart valve or a previously implanted prosthetic heart valve; inflating the cutting balloon to increase an angle between the one or more blades and a longitudinal axis of the balloon in the inverted end portion; and cutting at least one of leaflets of the native heart valve or leaflets the previously implanted prosthetic heart valve with the one or more blades.

[0183] Example 27. The method of claim 26, wherein, in the collapsed configuration, each of the one or more blades is disposed within a pocket formed in an inner wall of the inverted end portion, and the inflating of the cutting balloon decreases a depth of the pocket.

[0184] Example 28. The method of either claim 26 or claim 27, further comprising further advancing the distal end portion of the medical apparatus until a radially compressed prosthetic heart valve mounted around a valve-expanding balloon is positioned within the one or more of the native heart valve or the previously implanted prosthetic heart valve; and after the prosthetic heart valve is positioned within the one or more of the native heart valve or the previously implanted prosthetic heart valve, inflating the valve-expanding balloon to radially expand the prosthetic heart valve.THVDL-23707W001

[0185] Example 29. A method comprising sterilizing the prosthetic heart valve, apparatus, and / or assembly of any example.

[0186] Example 30. A medical apparatus or assembly of any one of examples 1-25, wherein the prosthetic heart valve is sterilized.

[0187] Example 31. A medical apparatus for insertion within a subject’s body, the medical apparatus comprising a handle; a shaft that extends from the handle; and a balloon mounted around a first portion of the shaft and having a longitudinal axis, wherein the balloon comprises an inflatable main body that is inflatable from a collapsed configuration to an inflated configuration, wherein the main body comprises a main body end portion, the balloon further comprising one or more blades attached to the main body end portion.

[0188] Example 32. The medical apparatus of example 31, wherein the first portion of the shaft comprises a distal end portion of the shaft.

[0189] Example 33. The medical apparatus of either example 31 or example 32, wherein the main body end portion comprises an inverted end portion having an outer surface facing the longitudinal axis, and wherein the one or more blades are attached to the outer surface within the inverted end portion.

[0190] Example 34. The medical apparatus of any of examples 31-33, wherein the balloon is a first balloon, and the medical apparatus further comprises a second balloon mounted around a second portion of the shaft.

[0191] Example 35. The medical apparatus of example 34, wherein the second balloon is mounted proximal to the first balloon.

[0192] Example 36. The medical apparatus of any of examples 31-33, further comprising a valve expander positioned on a second portion of the shaft.

[0193] Example 37. The medical apparatus of example 36, wherein the valve expander is mounted proximal to the first balloon.

[0194] Example 38. The medical apparatus of either example 36 or example 37, wherein the valve expander comprises a mechanical actuator configured to apply an expansion force to a prosthetic valve.

[0195] Example 39. The medical apparatus of any of examples 36-38, wherein the valve expander comprises the second portion of the shaft having a prosthetic valve collapsed thereon and covered by a sheath, the prosthetic valve configured to self-expand to its functional size.THVDL-23707W001

[0196] Thus, specific examples of devices, apparatuses, and methods relating to inflatable balloons for medical devices have been disclosed. The above description of the disclosed implementations is provided to enable any person skilled in the art to make or use the devices and methods of the disclosure. The preceding detailed description illustrates examples and is not intended to limit the disclosure or the application and uses of the disclosed devices and methods. Various modifications to these implementations will be readily apparent to those skilled in the art, and the general principles described herein can be applied to other implementations without departing from the spirit or scope of the disclosure. Thus, it is to be understood that the description and drawings presented herein represent an implementation of the delivery apparatuses and are therefore representative of the subject matter which is broadly contemplated by the present application. It is further understood that the scope of the present application fully encompasses other implementations that may become obvious to those skilled in the art and that the scope of the present application is accordingly not limited.

[0197] Reference throughout this specification to “an implementation” means that a particular feature, structure, or characteristic described in connection with the implementation is included in at least one implementation. Thus, appearances of the phrases “in an implementation” in various places throughout this specification are not necessarily all referring to the same implementation or a single exclusive implementation. Furthermore, the particular features, structures, or characteristics described herein may be combined in any suitable manner in one or more implementations.

[0198] Unless specifically stated otherwise, the term “some” refers to one or more.

[0199] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one balloon can be combined with any one or more features of another balloon. Additionally and / or alternatively, any one or more features of one medical apparatus can be combined with any one or more features of another medical apparatus.

[0200] Groupings of alternative elements or implementations of the disclosure herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, theTHVDL-23707W001 specification is herein deemed to contain the group as modified thus fulfilling the written description of all groups used in the appended claims.

[0201] 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.

[0202] All structural and functional equivalents to the components of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

Claims

THVDL-23707W001CLAIMSWhat is claimed is:

1. A medical apparatus for insertion within a subject’s body, the medical apparatus comprising: a handle; a shaft that extends from the handle: and a balloon mounted around a distal end portion of the shaft and having a longitudinal axis, wherein the balloon comprises an inflatable main body that is inflatable from a collapsed configuration to an inflated configuration, wherein the main body comprises an inverted end portion having an outer surface facing the longitudinal axis, the balloon further comprising one or more blades attached to the outer surface within the inverted end portion.

2. The medical apparatus of claim 1, wherein the inverted end portion is a distal end portion of the main body.

3. The medical apparatus of either claim 1 or claim 2, wherein the inverted end portion forms an inverted cone when the main body is inflated.

4. The medical apparatus of claim 3, wherein, in the inflated configuration, a first end of each of the one or more blades is oriented toward a smaller end of the inverted cone and a second end of the blade is oriented toward a larger end of the inverted cone.

5. The medical apparatus of any of claims 1-4, wherein the one or more blades comprise a plurality of blades, wherein the plurality of blades extend radially relative to the longitudinal axis of the main body of the balloon and angle away from the longitudinal axis.

6. The medical apparatus of any of claims 1-5, wherein, in the collapsed configuration, each the one or more blades is parallel to the longitudinal axis.

7. The medical apparatus of any of claims 1-6, wherein, in the collapsed configuration, each the one or more blades is disposed within a pocket formed in an innerTHVDL-23707W001 wall of the inverted end portion of the main body of the balloon and a cutting edge of the blade is recessed relative to the outer surface of the balloon within the inverted end portion.

8. The medical apparatus of claim 7, wherein the inflated configuration is a fully inflated configuration, and wherein the inflatable main body is inflatable from the collapsed configuration to a partially inflated configuration, and from the partially inflated configuration to the fully inflated configuration, wherein, in the partially inflated configuration, each the one or more blades is angled away from the longitudinal axis and is disposed within the respective pocket.

9. The medical apparatus of any of claims 1-8, wherein, in the inflated configuration, the balloon is configured for cutting one or more of an anatomical structure or a portion of a previously implanted prosthetic valve within a subject.

10. The medical apparatus of any of claims 1-9, wherein the balloon is a first balloon, and the medical apparatus further comprises a second balloon mounted around the distal end portion of the shaft.

11. The medical apparatus of claim 10, further comprising an implantable prosthetic heart valve that is radially collapsible to a radially collapsed configuration and radially expandable to a radially expanded configuration, wherein the prosthetic heart valve is mounted around the second balloon in the radially collapsed configuration and is radially expandable to the radially expanded configuration when the second balloon is inflated.

12. The medical apparatus of any of claims 1-11, wherein the one or more blades comprise three blades.

13. An assembly comprising: a delivery apparatus comprising: a shaft assembly comprising a first shaft and a second shaft;THVDL-23707W001 a first balloon coupled to a distal portion of the first shaft and having a longitudinal axis: a second balloon coupled to the distal portion of the second shaft, wherein the first balloon is distal relative to the second balloon; and an implantable prosthetic heart valve that is radially collapsible to a radially collapsed configuration and radially expandable to a radially expanded configuration, wherein the prosthetic heart valve is mounted around the second balloon in the radially collapsed configuration and is radially expandable to the radially expanded configuration when the second balloon is inflated; wherein the first balloon comprises a main body that is inflatable from a collapsed configuration to an inflated configuration and one or more blades, wherein the main body comprises a proximal portion and a distal portion, wherein one or more blades are attached to the distal portion of the main body.

14. The assembly of claim 13, wherein, in the inflated configuration of the main body of the first balloon, the one or more blades are angled away from the longitudinal axis of the first balloon in a proximal to distal direction and are configured for cutting a structure at a target implantation site.

15. The assembly of either claim 13 or claim 14, wherein the distal portion of the main body comprises an inverted end portion, and wherein, in the inflated configuration of the main body of the first balloon, the inverted end portion forms an inverted cone.

16. The assembly of any of claims 13-15, wherein in the collapsed configuration of the main body of the first balloon, each the one or more blades is parallel to the longitudinal axis.

17. The assembly of any of claims 13-16, wherein, in the collapsed configuration of the main body of the first balloon, each of the one or more blades is disposed within a pocket formed in an inner wall of the distal portion of the main body of the balloon and a cutting edge of each of the one or more blades is oriented towards the longitudinal axis.THVDL-23707W00118. A method comprising : introducing a distal end portion of a medical apparatus into vasculature of a subject, the medical apparatus comprising a handle portion, an elongated shaft extending from the handle portion, the distal end portion comprising an inflatable cutting balloon mounted on the shaft, wherein the inflatable cutting balloon comprises one or more blades and a main body comprising a proximal portion and a distal portion, wherein the one or more blades are attached to the distal portion, wherein the main body of the inflatable cutting balloon is in a collapsed configuration ; advancing, while the cutting balloon is in the collapsed configuration, the distal end portion of the medical apparatus toward one or more of a native heart valve or a previously implanted prosthetic heart valve: inflating the main body of the cutting balloon to increase an angle between the one or more blades and a longitudinal axis of the balloon in the distal portion; and cutting at least one of leaflets of the native heart valve or leaflets the previously implanted prosthetic heart valve with the one or more blades.

19. The method of claim 18, wherein the distal portion of the main body of the cutting balloon is an inverted end portion, and wherein, in the collapsed configuration, each of the one or more blades is disposed within a pocket formed in an inner wall of the inverted end portion, and wherein the inflating of the main body of the cutting balloon decreases a depth of the pocket.

20. The method of either claim 18 or claim 19, further comprising further advancing the distal end portion of the medical apparatus until a radially compressed prosthetic heart valve mounted around a valve-expanding balloon is positioned within the one or more of the native heart valve or the previously implanted prosthetic heart valve; and after the prosthetic heart valve is positioned within the one or more of the native heart valve or the previously implanted prosthetic heart valve, inflating the valve-expanding balloon to radially expand the prosthetic heart valve.

21. A medical apparatus for insertion within a subject’s body, the medical apparatus comprising:THVDL-23707W001 a handle; a shaft that extends from the handle; and a balloon mounted around a first portion of the shaft and having a longitudinal axis, wherein the balloon comprises an inflatable main body that is inflatable from a collapsed configuration to an inflated configuration, wherein the main body comprises a main body end portion, the balloon further comprising one or more blades attached to the main body end portion.

22. The medical apparatus of claim 21, wherein the first portion of the shaft comprises a distal end portion of the shaft.

23. The medical apparatus of either claim 21 or claim 22, wherein the main body end portion comprises an inverted end portion having an outer surface facing the longitudinal axis, and wherein the one or more blades are attached to the outer surface within the inverted end portion.

24. The medical apparatus of any of claims 21-23, wherein the balloon is a first balloon, and the medical apparatus further comprises a second balloon mounted around a second portion of the shaft.

25. The medical apparatus of any of claims 24, wherein the second balloon is mounted proximal to the first balloon.

26. The medical apparatus of any of claims 21-23, further comprising a valve expander positioned on a second portion of the shaft.

27. The medical apparatus of claim 26, wherein the valve expander is mounted proximal to the first balloon.

28. The medical apparatus of either claim 26 or claim 27, wherein the valve expander comprises a mechanical actuator configured to apply an expansion force to a prosthetic valve.THVDL-23707W00129. The medical apparatus of any of claims 26-28, wherein the valve expander comprises the second portion of the shaft having a prosthetic valve collapsed thereon and covered by a sheath, the prosthetic valve configured to self-expand to its functional size.

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