Methods, assemblies, and apparatus for prosthetic valve deployment and post-implantation adjustment

Abstract

Delivery apparatus and methods for implanting and / or post-implantation adjustment of prosthetic heart valves. The disclosed delivery apparatuses and methods can provide improved implantation of prosthetic heart valves by enabling increase of a working range of a prosthetic valve. The delivery apparatuses and methods can enable implantation of a prosthetic heart valve at a diameter that is below a minimum diameter of a normal working range of the prosthetic valve, at a diameter that is above a maximum diameter of a normal working range of the prosthetic valve, or at a diameter that is within a normal working range. A set of delivery apparatuses can include delivery apparatuses having differently shaped balloons, such as a parallel balloon, a tapered balloon, and a flared balloon. The delivery apparatuses can be selectable from the set to achieve a desired implantation diameter or implantation configuration of a prosthetic valve.

Description

METHODS, ASSEMBLIES, AND APPARATUS FOR PROSTHETIC VALVE DEPLOYMENT AND POST-IMPLANTATION ADJUSTMENTCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 733,524, filed December 13, 2024, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to delivery apparatuses and methods for implanting prosthetic heart valves, for example, delivery apparatuses including balloons of different shapes for radially expanding prosthetic heart valves and associated methods of use.BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then radially expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.

[0004] Most expandable prosthetic heart valves comprise a radially expandable and compressible cylindrical metal frame and prosthetic leaflets mounted inside the frame. Each leaflet can comprise a main body with a cusp edge portion, a free edge portion opposing the cusp edge portion, and a set of commissure tabs extending from the main body on opposite sides of the leaflet. The leaflets can be secured to one another at adjacent commissure tabs toform commissures that are then secured to the frame of the prosthetic heart valve. The cusp edge portion of each leaflet can also be coupled to struts of the frame. The free edge of each leaflet is configured to move between an open position and a coaptation position (that is, where the leaflet free edge is in a position to coapt with the free edges of adjacent leaflets) in order to open and close the prosthetic heart valve. The opening and closing of the leaflets regulates a flow of blood through the prosthetic heart valve, from an inflow end to an outflow end of the prosthetic heart valve.SUMMARY

[0005] Described herein are prosthetic heart valves, delivery apparatus, and methods for implanting and / or post-implantation adjustment of prosthetic heart valves. The disclosed prosthetic heart valves, delivery apparatus, and methods can, for example, provide improved implantation of prosthetic heart valves by enabling increase of a working range of the prosthetic heart valve. In some examples, the prosthetic heart valves, delivery apparatus, and methods can enable implantation of a prosthetic heart valve in a native annulus having a diameter that results in the prosthetic heart valve being implanted at a diameter that is below a minimum diameter of a normal working range of the prosthetic heart valve. In some examples, the prosthetic heart valves, delivery apparatus, and methods can enable implantation of a prosthetic heart valve in a native annulus having a diameter that results in the prosthetic heart valve being implanted at a diameter that is above a maximum diameter of a normal working range of the prosthetic heart valve. In some examples, the prosthetic heart valves, delivery apparatus, and methods can enable implantation of a prosthetic heart valve in a native annulus having a diameter that results in the prosthetic heart valve being implanted at a diameter that is within a normal working range of the prosthetic heart 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.

[0006] A delivery apparatus can include a handle, a shaft coupled to the handle, and a balloon coupled to a distal end portion of the shaft.

[0007] In some examples, the balloon can be shaped to have a parallel inflation configuration.

[0008] In some examples, in the parallel inflation configuration, a diameter of a working portion of the inflated balloon is constant.

[0009] In some examples, in the parallel inflation configuration, a wall of the inflated balloon along the working portion of the balloon is in a parallel orientation relative to a central axis of the inflated balloon.

[0010] In some examples, the balloon can be shaped to have a flared inflation configuration.

[0011] In some examples, in the flared inflation configuration, a proximal end portion of the working portion of the inflated balloon has a greater diameter than its distal end portion.

[0012] In some examples, in the flared inflation configuration, at least a portion of a wall of the balloon is angled, in a distal to proximal direction, away from a central axis of the inflated balloon.

[0013] In some examples, the balloon can be shaped to have a tapered inflation configuration.

[0014] In some examples, in the tapered inflation configuration, a distal end portion of the working portion of the inflated balloon has a greater diameter than its proximal end portion.

[0015] In some examples, in the tapered inflation configuration, at least a portion of a wall of the balloon is angled, in a distal to proximal direction, toward a central axis of the inflated balloon.

[0016] In some examples, a set of delivery apparatuses can include delivery apparatuses with differently shaped balloons.

[0017] In some examples, a set of delivery apparatuses can include a delivery apparatus with a parallel balloon, a delivery apparatus with a flared balloon, and a delivery apparatus with a tapered balloon.

[0018] In some examples, the delivery apparatuses can be selectable from the set of delivery apparatuses for radially expanding a prosthetic valve to a desired diameter or to a desired implantation configuration.

[0019] In some examples, a delivery apparatus including a parallel balloon can be utilized for radially expanding a prosthetic valve to a parallel implantation configuration.

[0020] In some examples, in a parallel implantation configuration, the prosthetic heart valve can be implanted at a diameter that is within its normal working range.

[0021] In some examples, in a parallel implantation configuration, inflow and outflow end portions of the prosthetic valve are radially expanded to a same diameter or a similar diameter (for example, a first diameter that is + / -1% of a second diameter).

[0022] In some examples, in a parallel implantation configuration, a frame of the prosthetic valve is cylindrical in the radially expanded state such that the sides of the frame in a vertical cross-sectional profile are in a parallel orientation relative to a central axis of the radially expanded prosthetic heart valve.

[0023] In some examples, a delivery apparatus including a flared balloon can be utilized to radially expand a prosthetic heart valve to a flared implantation configuration.

[0024] In some examples, in a flared implantation configuration, the prosthetic heart valve can be implanted at a diameter that is below the minimum diameter of the normal working range.

[0025] In some examples, in a flared implantation configuration, the outflow end portion of the radially expanded prosthetic valve has a greater diameter than its inflow end portion.

[0026] In some examples, in a flared implantation configuration, the sides of the expanded frame in a vertical cross-sectional profile are angled, in an inflow to outflow direction, away from a central axis of the radially expanded prosthetic heart valve.

[0027] In some examples, a delivery apparatus including a tapered balloon can be utilized to radially expand a prosthetic heart valve to a tapered implantation configuration.

[0028] In some examples, in a tapered implantation configuration, the prosthetic heart valve can be implanted at a diameter that is above the maximum diameter of the normal working range.

[0029] In some examples, in a tapered implantation configuration, the inflow end portion of the radially expanded prosthetic valve has a greater diameter than its outflow end portion.

[0030] In some examples, in a tapered implantation configuration, the sides of expanded frame in a vertical cross-section profile are angled, in an inflow to outflow direction, toward a central axis of the radially expanded prosthetic heart valve.

[0031] In some examples, a balloon shape can be selected based on one or more structural features of the prosthetic heart valve to achieve a desired implantation configuration for the prosthetic valve.

[0032] An assembly can comprise a delivery apparatus having one or more of the foregoing features and a prosthetic heart valve radially compressed around the balloon at the distal end of the shaft of the delivery apparatus.

[0033] A method can include analyzing one or more characteristics of an implantation site (which can be, for example, a native annulus or a previously implanted prosthetic heart valve), determining a desired prosthetic valve implantation configuration, shape, and / or diameter, and selecting a delivery apparatus having one of a parallel balloon, a flared balloon or a tapered balloon based on the desired prosthetic valve implantation configuration, shape, and / or diameter.

[0034] In some examples, the method can be a method for implanting a prosthetic heart valve.

[0035] In some examples, the method can be a method for post-implantation adjustment of a prosthetic heart valve.

[0036] In one representative example, A method comprising: determining one or more characteristics of a target implantation site; based on the one or more characteristics of the target implantation site, determining one or more of a target implantation diameter or a target implantation configuration for a prosthetic heart valve; based at least on the one or more of the target implantation diameter or the targeted implantation configuration, selecting a delivery apparatus from a set of delivery apparatuses each having a balloon with a different shape; advancing a distal end portion of the selected delivery apparatus to a native heart valve; and inflating to the balloon of the selected delivery apparatus to radially expand the prosthetic heart valve to the one or more of the targeted implantation diameter or the target implantation configuration at the target implantation site.

[0037] In one representative example, a method comprising: determining a target implantation configuration for a prosthetic heart valve; based at least on the target implantation configuration, selecting a delivery apparatus from a set of delivery apparatuses, the set of delivery apparatus including a first delivery apparatus with a parallel balloon, a second delivery apparatus with a flared balloon, and a third delivery apparatus with a tapered balloon; and inflating the balloon of the selected delivery apparatus to radially expand the prosthetic heart valve to the target implantation configuration.

[0038] In one representative example, a method of implanting a prosthetic heart valve, the method comprises: identifying one or more characteristics of a target implantation site within a subject that are indicative of an implantation diameter that is lower than a minimum diameter of a normal working range of the prosthetic heart valve when implanted in a parallel implantation configuration, wherein in the parallel implantation configuration a diameter of an inflow end portion of the prosthetic heart valve is equal to a diameter of an outflow end portion of the prosthetic heart valve; selecting a delivery apparatus that includes a flared balloon coupled to a distal end portion of a shaft of the delivery apparatus; advancing the distal end portion of the shaft having the prosthetic heart valve radially compressed around the flared balloon through vasculature of the subject to the target implant site; and inflating the flared balloon to radially expand the prosthetic heart valve to a flared implantation configuration.

[0039] In one representative example, a method of implanting a prosthetic heart valve, the method comprises: identifying one or more characteristics of a target implantation site within a subject that are indicative of an implantation diameter that is greater than a maximum diameter of a normal working range of the prosthetic heart valve when implanted in a parallel implantation configuration, wherein in the parallel implantation configuration a diameter ofan inflow end portion of the prosthetic heart valve is equal to a diameter of an outflow end portion of the prosthetic heart valve: selecting a delivery apparatus that includes a tapered balloon coupled to a distal end portion of a shaft of the delivery apparatus; advancing the distal end portion of the shaft having the prosthetic heart valve radially compressed around the tapered balloon through vasculature of the subject to the target implant site; and inflating the tapered balloon to radially expand the prosthetic heart valve to a tapered implantation configuration.

[0040] In one representative example, an assembly comprises: a prosthetic heart valve comprising an annular frame and a valve structure disposed within an interior space of the frame and having an inflow end portion and an outflow end portion, the valve structure comprising a plurality of leaflets, each of the leaflets joined to an adjacent leaflet at the outflow end portion of the valve structure to form a commissure therebetween, each of the commissures attached to the frame; and a delivery apparatus comprising a shaft and a tapered balloon coupled to a distal end portion of the shaft, wherein the tapered balloon comprises an intermediate portion configured to receive the prosthetic heart valve radially compressed therearound, wherein the intermediate portion has a proximal end and a distal end; wherein, in an inflated state of the tapered balloon, the distal end of the intermediate portion has greater diameter than its proximal end, and a first section of the intermediate portion extending from the proximal end in a proximal to distal direction comprises an angled wall that angles away from a central axis of the tapered balloon and intersects with a second section of the intermediate portion that comprises a parallel wall that is parallel to the central axis of the tapered balloon, wherein the angled wall intersects with the parallel wall at an intersection.

[0041] In one representative example, a method of implanting a prosthetic heart valve, the method comprises: identifying one or more characteristics of a target implantation site within a subject that are indicative of an implantation diameter that is lower than a minimum diameter of a normal working range of the prosthetic heart valve when implanted in a parallel implantation configuration, wherein in the parallel implantation configuration a diameter of an inflow end portion of the prosthetic heart valve is equal to a diameter of an outflow end portion of the prosthetic heart valve; advancing a distal end portion of a shaft of a delivery apparatus and the prosthetic heart valve through vasculature of the subject to the target implant site, wherein the prosthetic heart valve is in a radially compressed state; and radially expanding the prosthetic heart valve to a flared implantation configuration wherein thediameter of the inflow end portion of the prosthetic heart valve is less than the diameter of the outflow end portion of the prosthetic heart valve.

[0042] In one representative example, a method of implanting a prosthetic heart valve, the method comprises: identifying one or more characteristics of a target implantation site within a subject that are indicative of an implantation diameter that is greater than a maximum diameter of a normal working range of the prosthetic heart valve when implanted in a parallel implantation configuration, wherein in the parallel implantation configuration a diameter of an inflow end portion of the prosthetic heart valve is equal to a diameter of an outflow end portion of the prosthetic heart valve; advancing a distal end portion of a shaft of a delivery apparatus and the prosthetic heart valve through vasculature of the subject to the target implant site, wherein the prosthetic heart valve is in a radially compressed state; and radially expanding the prosthetic heart valve to a tapered implantation configuration wherein the diameter of the inflow end portion of the prosthetic heart valve is greater than the diameter of the outflow end portion of the prosthetic heart valve.

[0043] In one representative example, an assembly comprises: a first delivery apparatus comprising a shaft and a first balloon, wherein the first balloon is a parallel balloon coupled to a distal end portion of the shaft of the first delivery apparatus, wherein the parallel balloon comprises an intermediate portion configured to receive the prosthetic heart valve radially compressed therearound, wherein the intermediate portion of the parallel balloon has a proximal end and a distal end, and wherein, in an inflated state of the parallel balloon, the distal end of the intermediate portion has same diameter as the proximal end; and a second delivery apparatus comprising a shaft and a second balloon, wherein the second balloon is one of a tapered balloon or a flared balloon coupled to a distal end portion of the shaft of the second delivery apparatus.

[0044] In one representative example, a delivery apparatus comprises: a shaft; and a balloon coupled to a distal end portion of the shaft, wherein the balloon comprises an intermediate portion configured to receive a prosthetic heart valve radially compressed therearound, wherein the intermediate portion has a proximal end and a distal end; wherein, in an inflated state of the balloon, the intermediate portion comprises a cylindrical portion and an angled portion, wherein a wall of the balloon in the cylindrical portion is parallel to a longitudinal axis of the balloon, wherein a wall of the balloon in the angled portion is angled relative to the longitudinal axis of the balloon, and wherein an intersection between the wall of the balloon in the cylindrical portion and the wall of the balloon in the angled portion forms an angle on an exterior surface of the balloon in a range of 181° to 270°.

[0045] In some examples, a method is provided comprising detemrining one or more characteristics of a target implantation site; based at least in part on the one or more characteristics of the target implantation site, determining one or more of a target implantation diameter or a target implantation configuration for a prosthetic heart valve; based at least in part on the one or more of the target implantation diameter or the targeted implantation configuration, selecting a delivery apparatus from a set of delivery apparatuses each having a balloon with a different shape; advancing a distal end portion of the selected delivery apparatus to the target implantation site; and inflating the balloon of the selected delivery apparatus to radially expand the prosthetic heart valve.

[0046] In some examples, the target implantation site comprises at least one of a native valve and a prosthetic valve.

[0047] In some examples, a method is provided comprising determining a target implantation configuration for a prosthetic heart valve; based at least on the target implantation configuration, selecting a delivery apparatus from a set of delivery apparatuses, the set of delivery apparatus including at least a first delivery apparatus and a second delivery apparatus having different balloon shapes, wherein each balloon shape of the different balloon shapes is selected from parallel, flared, and tapered; and inflating the balloon of the selected delivery apparatus to radially expand the prosthetic heart valve to the target implantation configuration.

[0048] In some examples, a prosthetic heart valve, a delivery apparatus, a delivery assembly, and / or a method can comprise one or more of the components and / or steps recited in Examples 1-46 below.

[0049] 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).

[0050] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

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

[0052] FIG. IB is a perspective view of the prosthetic valve of FIG. 1 A with the components on the outside of the frame shown in transparent lines for purpose of illustration.

[0053] FIG. 2A is a side view of an exemplary delivery apparatus configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site.

[0054] FIG. 2B is a cross-sectional side view of a distal end portion of the delivery apparatus of FIG. 2A.

[0055] FIGS. 3A-3C are schematic illustrations of implanted prosthetic valves in exemplary parallel, flared, and tapered implantation configurations, respectively.

[0056] FIGS. 4A-4C are schematic illustrations of exemplary parallel, flared, and tapered balloons, respectively, that can be utilized with the delivery apparatus of FIGS. 2A and 2B.

[0057] FIGS. 5A-5C are schematic illustrations of prosthetic valves in exemplary parallel, flared, and tapered implantation configurations, respectively, that can be achieved utilizing the balloons of FIGS. 4A-4C.

[0058] FIGS. 6A-6C are illustrations of exemplary parallel, flared, and tapered balloons, respectively, that can be utilized with the delivery apparatus of FIGS. 2A and 2B.

[0059] FIGS. 7A-7C are illustrations of implanted prosthetic valves in exemplary parallel, flared, and tapered implantation configurations, respectively, that can be achieved utilizing the balloons of FIGS. 6A-6C.

[0060] FIGS. 8A-8B are schematic illustrations of exemplary flared and tapered balloons, respectively, that can be utilized with the delivery apparatus of FIGS. 2A and 2B.

[0061] FIGS. 9A-9B are illustrations of implanted prosthetic valves in exemplary flared and tapered implantation configurations, respectively, that can be achieved utilizing the balloons of FIGS. 8A-8B.

[0062] FIGS. 10A-10B are schematic illustrations of exemplary flared and tapered balloons, respectively, that can be utilized with the delivery apparatus of FIGS. 2A and 2B.

[0063] FIGS. 11A-1 IB are illustrations of implanted prosthetic valves in exemplary flared and tapered implantation configurations, respectively, that can be achieved utilizing the balloons of FIGS. 10A-10B.

[0064] FIG. 12 is a schematic illustration of an exemplary functional working range of a prosthetic valve that can be achieved utilizing the delivery apparatus and balloons disclosed herein.

[0065] FIGS. 13-15 are logical flow diagrams of exemplary methods of utilizing the delivery apparatus and balloons disclosed herein.DETAILED DESCRIPTIONGeneral Considerations

[0066] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be 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.

[0067] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth herein. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0068] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps not expressly referenced. Further, the term “coupled" generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. It is further noted that the claims can be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.

[0069] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the subject’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the subject’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0070] Reference throughout this specification to “an implementation” means that a particular feature, structure, or characteristic described in connection with the implementation is included in at least one implementation. Thus, appearances of the phrases “in an implementation” and “in some implementations” in various places throughout this specification are not necessarily all referring to the same implementation or a single exclusive implementation. Furthermore, the particular features, structures, or characteristics described herein may be combined in any suitable manner in one or more implementations.

[0071] The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any aspect described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects. Unless specifically stated otherwise, the term “some” refers to one or more.

[0072] 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.

[0073] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of the Disclosed Technology

[0074] As introduced above, prosthetic valves 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 from the compressed state to the radiallyexpanded state once the prosthetic valve reaches the implantation site. In some examples, a diameter to which the prosthetic valve will be radially expanded when it is implanted can be defined by and / or determined by analysis of one or more characteristics of the implantation site. For example, a diameter to which the prosthetic valve will be radially expanded can be determined (at least in part) by a size of a native annulus (for example, a diameter of a native annulus) in which the prosthetic valve will be implanted, as expansion of the prosthetic heart valve will be limited by contact with the tissue of the native annulus.

[0075] Prosthetic heart valves typically have a working range, defined by a minimum diameter and a maximum diameter over which sufficient opening of the leaflets and sufficient coaptation between the leaflet free edges can be maintained for regulating blood flow through the prosthetic valve. In some examples, where a native annulus is of a (smaller) diameter that results in the prosthetic heart valve being expanded to a diameter that is below the minimum diameter of the working range, the leaflets may not sufficiently open to permit adequate blood flow therethrough. In some examples, where a native annulus is of a (larger) diameter that results in the prosthetic heart valve being expanded to a diameter that is above the maximum diameter of the working range, the leaflets free edges may not sufficiently coapt to seal and / or close the prosthetic valve to prevent blood flow therethrough. Thus, prosthetic heart valves of differing sizes and working ranges may be required to treat a group of subjects, particularly those subjects having smaller or larger sized annuluses relative to other subjects.

[0076] Disclosed herein are prosthetic heart valves, delivery apparatus, and methods that can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatuses and methods of implantation. For example, the disclosed prosthetic heart valves, delivery apparatus, and methods can, for example, enable increase of a functional working range of a prosthetic heart valve relative to its normal working range.

[0077] In some examples, a normal working range of a prosthetic heart valve is defined by a minimum diameter and a maximum diameter over which sufficient opening of the leaflets and sufficient coaptation between the leaflet free edges can be maintained when the prosthetic valve is implanted in a parallel implantation configuration. As used herein, the parallel implantation configuration of the prosthetic heart valve is a configuration where inflow and outflow end portions of the prosthetic valve are radially expanded to a same diameter or a similar diameter (for example, a first diameter that is + / -1% of a second diameter). In some examples, the parallel implantation configuration of the prosthetic heartvalve can be a configuration where its frame is cylindrical in the radially expanded state such that the sides of the frame in a vertical cross-sectional profile are in a parallel orientation relative to a central axis of the radially expanded prosthetic heart valve.

[0078] In some examples, the delivery apparatus and assemblies and associated methods disclosed herein can enable implanting of a prosthetic valve in a flared implantation configuration so that the prosthetic heart valve can be implanted at a diameter that is below the minimum diameter of the normal working range. As used herein, the flared implantation configuration of the prosthetic heart valve is a configuration where the outflow end portion of the radially expanded prosthetic valve has a greater diameter than its inflow end portion. In some examples, the flared implantation configuration of the prosthetic heart valve can be a configuration where at least a portion of the sides of the expanded frame in a vertical cross- sectional profile are angled, in an inflow to outflow direction, away from a central axis of the radially expanded prosthetic heart valve.

[0079] In some examples, the delivery apparatus and assemblies and associated methods disclosed herein can enable implanting of a prosthetic valve in a tapered implantation configuration so that the prosthetic heart valve can be implanted at a diameter that is above the maximum diameter of the normal working range. As used herein, the tapered implantation configuration of the prosthetic heart valve is a configuration where the inflow end portion of the radially expanded prosthetic valve has a greater diameter than its outflow end portion. In some examples, the tapered implantation configuration of the prosthetic heart valve can be a configuration where at least a portion of the sides of expanded frame in a vertical cross-section profile are angled, in an inflow to outflow direction, toward a central axis of the radially expanded prosthetic heart valve.

[0080] In some examples, delivery apparatus and / or a delivery assembly can include balloons of different shapes for radially expanding prosthetic valves to desired or selected implantation configuration (for example, a parallel implantation configuration, a tapered implantation configuration, or a flared implantation configuration).

[0081] In some examples, a delivery apparatus can include a balloon shaped to have a parallel inflation configuration (which can also be referred to “a parallel balloon”). As used herein, the parallel inflation configuration of the balloon is a configuration where the working portion of the balloon (which can also be referred to as a “valve mounting region”) has a constant diameter. In some examples, the parallel inflation configuration of the balloon can be a configuration where a wall of the balloon along the working portion of the balloon is in a parallel orientation relative to a central axis of the inflated balloon. In some examples, aparallel balloon can be utilized to radially expand a prosthetic heart valve to a parallel implantation configuration.

[0082] In some examples, a delivery apparatus can include a balloon shaped to have a flared inflation configuration (which can also be referred to “a flared balloon”). As used herein, the flared inflation configuration is a configuration where a proximal end portion of the working portion (which can also be referred to as a “valve mounting region”) of the inflated balloon has a greater diameter than its distal end portion. In some examples, the flared inflation configuration can be a configuration where at least a portion of a wall of the balloon is angled, in a distal to proximal direction, away from a central axis of the inflated balloon. In some examples, a flared balloon can be utilized to radially expand a prosthetic heart valve to a flared implantation configuration.

[0083] In some examples, a delivery apparatus can include a balloon shaped to have a tapered inflation configuration (which can also be referred to “a tapered balloon”). As used herein, the tapered inflation configuration is a configuration where a distal end portion of the working portion (which can also be referred to as a “valve mounting region”) of the inflated balloon has a greater diameter than its proximal end portion. In some examples, the tapered inflation configuration can be a configuration where at least a portion of a wall of the balloon is angled, in a distal to proximal direction, toward a central axis of the inflated balloon. In some examples, a tapered balloon can be utilized to radially expand a prosthetic heart valve to a tapered implantation configuration.

[0084] In some examples, a method can include analyzing one or more characteristics of an implantation site (which can be, for example, a native annulus or a previously implanted prosthetic heart valve), determining a desired prosthetic valve implantation configuration, shape, and / or diameter, and selecting a delivery apparatus having one of a parallel balloon, a flared balloon or a tapered balloon based on the desired prosthetic valve implantation configuration, shape, and / or diameter. In some examples, the method can be a method for implanting a prosthetic heart valve. In some examples, the method can be a method for postimplantation adjustment of a prosthetic heart valve.

[0085] It will be appreciated 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 are discussed in detail below.Examples of the Disclosed Technology

[0086] FIGS. 1A and IB show an exemplary prosthetic valve 50, according to an example. Any of the prosthetic valves disclosed herein are adapted to be implanted in thenative 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.

[0087] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Patent No. 10,363130, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020 / 247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Patent No. 11,291,540, which is incorporated herein by reference.

[0088] The prosthetic valve 50 can have three main components: a stent or frame, 52, a valvular structure 54, and a sealing member 56 (FIG. 1A). FIG. IB is a perspective view of the prosthetic valve 50 with the components on the outside of the frame 52 (including the sealing member 56) shown in transparent lines for purposes of illustration. The prosthetic valve 50 can have an inflow end 66 and an outflow end 68.

[0089] The valvular structure 54 can comprise three leaflets 60, 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 (e.g., one or more leaflets 60). In some examples, the leaflets 60 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated by reference herein.

[0090] Each leaflet 60 can be coupled to the frame 52 along its inflow edge 62 (the lower edge in the figures: also referred to as “cusp edges’’) and at commissures 64 of the valvular structure 54 where adjacent portions (e.g., commissure tabs) of two leaflets are connected to each other. In some examples, the commissures 64 can comprise an attachment member (e.g., comprising fabric, flexible polymer, or the like) arranged across a cell (e.g., commissure cell) of the frame 52, the cell formed by struts of the frame. The attachment member can be secured to the struts of the frame forming the cell and the adjacent portions of the two leaflets can be connected to the attachment member to form the commissure 64.

[0091] In some examples, a reinforcing element or connecting skirt, such as a fabric strip, can be connected directly to the cusp edges of the leaflets and to the struts of the frame to couple the cusp edges of the leaflets to the frame.

[0092] The frame 52 can be made of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol). When constructed of a plastically-expandable material, the frame 52 (and thus the prosthetic valve 50) can be crimped to a radially collapsed configuration on a delivery apparatus (e.g., catheter) and then expanded inside a subject by an inflatable balloon or equivalent expansion mechanism. Various crimping devices can be used to crimp the prosthetic valve 50 and the other prosthetic valves described herein around the delivery apparatus, such as the crimping devices described in U.S. Patent No. 7,530,253, which is incorporated herein by reference.

[0093] In some examples, the prosthetic valve 50 can be crimped directly onto the inflatable balloon of the delivery apparatus, such that the prosthetic valve 50 is axially aligned with and disposed radially outward of the balloon during advancing the prosthetic valve on the delivery apparatus to the implantation site, for example as described in PCT Patent Application Publication No. WO / 2022 / 046585, which is incorporated herein by reference. In some examples, the prosthetic valve 50 can be crimped onto the delivery apparatus axially offset from the balloon, and then moved over the balloon at the implantation site, prior to inflation of the balloon and radial expansion of the prosthetic valve, such as described in U.S. Patent Application 9,339,384, which is incorporated herein by reference.

[0094] When constructed of a self-expandable material, the frame 52 (and thus the prosthetic valve 50) can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of a delivery apparatus. Once inside the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.

[0095] Suitable plastically -expandable materials that can be used to form the frame 52 include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 52 can comprise stainless steel. In some examples, the frame 52 can comprise cobalt-chromium. In some examples, the frame 52 can comprise nickel-cobalt-chromium. In some examples, the frame 52 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 R3OO35 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0096] The frame 52 in the illustrated example comprises a plurality of circumferentially extending rows of angled struts 72 defining rows of open cells 74 (or openings) of the frame. The frame 52 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 66 to the outflow end 68 of the frame 52 as shown, or the frame 52 can vary in diameter along the height of the frame, as disclosed in U.S. Patent No. 9,155,619, which is incorporated herein by reference.

[0097] The frame 52, at each of the inflow end 66 and the outflow end 68, may comprise a plurality of apices 80 spaced apart from one another around a circumference of the frame 52.

[0098] The sealing member 56 in the illustrated example is mounted on the outside of the frame 52 and functions to create a seal against the surrounding tissue (e.g., the native leaflets and / or native annulus) to prevent or at least minimize paravalvular leakage. The sealing member 56 can comprise an inner layer 76 (which can be in contact with the outer surface of the frame 52) and an outer layer 78. The sealing member 56 can be connected to the frame 52 using suitable techniques or mechanisms. In some examples, the sealing member 56 can be sutured to the frame 52 via sutures that can extend around the struts 72 and through the inner layer 76. In some examples, the inner layer 76 can be mounted on the inner surface of the frame 52, while the outer layer 78 is on the outside of the frame 52.

[0099] The outer layer 78 can be configured or shaped to extend radially outward from the inner layer 76 and the frame 52 when the prosthetic valve 50 is deployed. When the prosthetic valve is fully expanded outside of a subject’s body, the outer layer 78 can expand away from the inner layer 76 to create a space between the two layers. Thus, when implanted inside the body, this allows the outer layer 78 to expand into contact with the surrounding tissue.

[0100] Additional details regarding the prosthetic valve 50 and its various components are described in U.S. Patent No. 11,096,781, which is incorporated herein by reference.

[0101] FIG. 2 A shows an example delivery apparatus 100, which can be used to implant an expandable prosthetic heart valve (for example, the prosthetic valve 50 of FIGS. 1 A and IB), or another type of expandable prosthetic medical device (such as a stent). A distal end portion 109 of the delivery apparatus 100 is shown in FIG. 2B. In some examples, the delivery apparatus 100 is specifically adapted for use in introducing a prosthetic valve into a heart. As described further herein, the delivery apparatus 100 can be configured to rotate the prosthetic valve, mounted on the delivery apparatus in a radially compressed state, at the target implantation site (for example, at a native valve of the heart) to achieve commissure alignment between the native valve and prosthetic valve after deploying the prosthetic valve.

[0102] In some examples, the delivery apparatus 100 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 both proximally and distally from the handle 102. The portion of the intermediate shaft 106 extending distally from the handle 102 also extends coaxially through the outer shaft 104. Additionally, the delivery apparatus 100 can further comprise an inner shaft 108 extending distally from the handle 102 and coaxially through the intermediate shaft 106 and the outer shaft 104. The inner shaft 108 also extends proximally from the handle 102 and coaxially through the intermediate shaft 106.

[0103] The outer shaft 104 and the intermediate shaft 106 are configured to translate 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.

[0104] 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. The knob 114 can be configured to rotate the intermediate shaft 106 around the central longitudinal axis 120 of the delivery apparatus 100 and relative to the outer shaft 104.

[0105] The adaptor 112 can include a first port 138 configured to receive a guide wire therethrough and a second port 140 configured to receive fluid (for example, inflation fluid) from a fluid source. The second port 140 can be fluidly coupled to an inner lumen of the intermediate shaft 106.

[0106] The intermediate shaft 106 can further include a distal end portion 116 that extends distally beyond a distal end of the outer shaft 104 when the distal end of the outer shaft 104 is positioned away from an inflatable balloon 118 of the delivery apparatus. A distal endportion of the inner shaft 108 can extend distally beyond the distal end portion 116 of the intermediate shaft 106.

[0107] The balloon 118 can be coupled to the distal end portion 1 16 of the intermediate shaft 106. For example, a proximal end portion of the balloon 118 can be coupled to and / or around a distal end 148 of the intermediate shaft 106.

[0108] The balloon 118 can comprise a distal end portion (or section) 132, a proximal end portion (or section) 133, and an intermediate portion (or section) 135, the intermediate portion 135 disposed between the distal end portion 132 and the proximal end portion 133.

[0109] In some examples, a distal end of the distal end portion 132 of the balloon 118 can be coupled to a distal end of the delivery apparatus 100, such as to a nose cone 122, or to an alternate component at the distal end of the delivery apparatus 100 (for example, a distal shoulder). In some examples, the intermediate portion 135 of the balloon 118 can overlay a valve mounting portion 124 of a distal end portion 109 of the delivery apparatus 100, the distal end portion 132 can overly a distal shoulder 126 of the delivery apparatus 100, and the proximal end portion 133 can surround a portion of the inner shaft 108 (FIG. 2B). The valve mounting portion 124 and the intermediate portion 135 of the balloon 118 can be configured to receive a prosthetic valve in a radially compressed state.

[0110] As described herein, rotation of the intermediate shaft 106 can cause rotation of the balloon 118 and the prosthetic valve mounted thereon for rotational positioning of the prosthetic valve relative to the native anatomy at the target implantation site.

[0111] The delivery apparatus 100 can include a balloon shoulder assembly 180 configured to maintain the prosthetic heart valve or other medical device at a fixed position on the balloon 118 during delivery through the subject's vasculature. The balloon shoulderassembly 180 can include a distal shoulder 126 arranged within a distal end portion of the balloon 118 and coupled to the distal end portion of the inner shaft 108. The distal shoulder 126 can be configured to resist movement of the prosthetic valve or other medical device mounted on the valve mounting portion 124 distally, in an axial direction (for example, along the central longitudinal axis 120), relative to the balloon 118.

[0112] For example, the distal shoulder 126 can include a flared portion 131 arranged adjacent to the valve mounting portion 124. In some examples, the flared portion 131 can include a plurality of wings 130 that flare radially outward from a base portion 125 (for example, shaft) of the distal shoulder 126, toward the valve mounting portion 124.

[0113] The outer shaft 104 can include a distal tip portion 128 mounted on its distal end. In some examples, the distal tip portion 128 can be configured as a flex adaptor including aplurality of inner and outer helical grooves. 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 a prosthetic valve is mounted in the radially compressed state on the valve mounting portion 124 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 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.

[0114] In some examples, the nose cone 122 can be disposed distal to and be coupled to the distal shoulder 126. In some examples, the nose cone 122 can be coupled to the distal end portion of the inner shaft 108.

[0115] In some examples, the delivery apparatus 100 can comprise one or more markers or marker bands 153 that are configured to indicate to a user a location of a specified component of the delivery apparatus. In some examples, the one or more marker bands 153 can be radiopaque. In some examples, one or more marker bands 153 can be radially compressed (for example, crimped) onto the inner shaft 108.

[0116] In some examples, the distal end portion 132 of the balloon 118 can include a radial depression 134 that is depressed radially inwardly, toward the central longitudinal axis 120, relative to an outermost radial surface of the distal shoulder 126 and an outermost radial surface of the nose cone 122.

[0117] An annular space 136 can be defined between an outer surface of the inner shaft 108 and an inner surface of the intermediate shaft 106. In some examples, the annular space 136 can be referred to as an inner lumen of the intermediate shaft 106. In some examples, the annular space 136 can be configured to receive an inflation fluid from a fluid source via the second port 140 of the adaptor 112 (for example, the annular space 136 can be in fluid communication with the second port 140 of the adaptor 112). The annular space 136 can be fluidly coupled to a fluid passageway 142 formed between the outer surface of the distal end portion of the inner shaft 108 and an inner surface of the balloon 118. As such, fluid from the fluid source can flow to the fluid passageway 142 from the annular space 136 to inflate the balloon 118 and radially expand and deploy the prosthetic valve.

[0118] In some examples, after crimping of the prosthetic valve onto the valve mounting portion 124, the distal tip portion 128 can be advanced over the proximal end portion 133 of the balloon 118. As a result, fluid arranged within the proximal end portion 133 of the balloon 118 can be displaced and pushed distally, within the balloon 118, to the distal endportion 132 of the balloon 118. The radially depressed, distal end portion 132 of the balloon 118 can then radially expand (for example, inflate partially) as it receives the displaced fluid to an expanded state. The radial depression 134 can be configured (for example, sized) so that the distal end portion 132 can receive the displaced fluid without radial expanding the portion of the balloon 118 within the valve mounting portion 124, thereby preventing the crimped profile of the prosthetic valve from increasing.

[0119] An inner lumen 144 of the inner shaft 108 can be configured to receive a guidewire therethrough, for navigating the distal end portion 109 of the delivery apparatus 100 to the target implantation site. As introduced above, the first port 138 of the adaptor 112 can be coupled to the inner lumen 144 and configured to receive the guidewire. For example, the distal end portion 109 of the delivery apparatus 100 can be advanced over the guidewire, to the target implantation site.

[0120] As shown in FIG. 2 A, the handle 102 can include a steering mechanism configured to adjust the curvature of the distal end portion 109 of the delivery apparatus 100. For example, the handle 102 can include an adjustment member, such as the illustrated rotatable knob 160, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 102 through the outer shaft 104 and has a distal end portion affixed to the outer shaft 104 at or near the distal end of the outer shaft 104. Rotating the knob 160 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion 109 of the delivery apparatus 100. Further details on steering or flex mechanisms for the delivery apparatus are described in U.S. Patent No. 9,339,384, which is incorporated by reference herein in its entirety.

[0121] The handle 102 can further include an adjustment mechanism 161 including an adjustment member, such as the illustrated rotatable knob 162. The adjustment mechanism 161 can be configured to move (thus adjust the axial position) of the intermediate shaft 106 relative to the outer shaft 104. The handle 102 can also include a locking mechanism configured to retain (for example, lock) the position of the intermediate shaft 106 relative to the handle 102. In some examples, the locking mechanism can include another adjustment member, which can be configured as a rotatable knob 178. In some examples, rotating the knob 178 to a locked position can cause the intermediate shaft 106 to frictionally engage with other components of the handle 102, thereby restraining movement of the intermediate shaft 106 for fine positioning of the prosthetic valve mounted on the distal end portion of the delivery apparatus 100. Rotating the knob 178 to an unlocked position allows axial and rotational movement of the intermediate shaft 106 relative to the proximal end portion of thehandle 102. For example, rotation of the knob 162 can cause the intermediate shaft 106 to move axially relative to the outer shaft 104 (either in the proximal or distal direction, depending on the direction the knob 162 is rotated).

[0122] Further details on the adjustment mechanism and locking mechanism of the handle 102 can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein in its entirety. Additional examples of delivery apparatuses and related steering mechanism can be found in U.S. Patent No. 8,568,472, which is incorporated herein by reference in its entirety.

[0123] According to certain examples, to implant a prosthetic valve (for example, prosthetic valve 50) in a native heart valve of the subject, the delivery apparatus 100 can be introduced into vasculature of the subject. The prosthetic valve can be initially retained in a radially compressed configuration on the valve mounting portion 124 (and over the balloon 118) of the delivery apparatus 100.

[0124] In some instances, once inside the subject’s vasculature, the position (e.g., axial position) of the prosthetic valve relative to the balloon 118 can be adjusted such that the prosthetic valve 50 is centered on the balloon 118. In some instances, the axial position of the prosthetic valve relative to the balloon 118 may not be adjusted.

[0125] When navigating the prosthetic valve through an arched region of the vasculature (for example, the aortic arch), the curvature of the distal end portion 109 of the delivery apparatus 100 can be adjusted, for example, by rotating the knob 160 to increase or decrease the tension in the pull wire which extends between the handle 102 and the distal end of the outer shaft 104. The prosthetic valve can be positioned within or adjacent an annulus of the native heart valve. Prior to inflating the balloon 118, the outer shaft 104 can be retracted proximally away from the balloon 118 for a sufficient distance so that the outer shaft does not interfere with balloon inflation. This can be accomplished, for example, by holding the adaptor 112 stationary against the operating table and rotating the knob 162 in a direction that causes the handle 102 and the outer shaft 104 to move proximally away from the balloon 118. Then, the prosthetic valve can be radially expanded and deployed by inflating the balloon 118.Inflation of the balloon 118 can radially expand the prosthetic valve 50 so that the prosthetic valve 50 contacts the native annulus. The expanded prosthetic valve 50 becomes anchored within the native aortic annulus by the radial outward force of the valve’s frame against the surrounding tissue.

[0126] As described above, the knob 114 of the handle 102 can be configured to rotate the intermediate shaft 106, thereby rotating the balloon 118 mounted on the intermediate shaft106 and a radially compressed prosthetic valve mounted on the balloon 118, around the valve mounting portion 124. Thus, rotating the knob 114 can rotate the prosthetic valve, around the central longitudinal axis 120, into a desired (circumferential or rotational) orientation relative to the native anatomy at the target implantation site.

[0127] For example, to implant a prosthetic valve (for example, prosthetic valve 50) at a native aortic valve, instead of deploying the prosthetic valve with the delivery apparatus 100 in a random rotational orientation relative to the aorta, which may result in commissures (for example, commissures 64) of the prosthetic valve being arranged in front of the coronary arteries, it may be desirable to deploy the prosthetic valve in a targeted rotational orientation where the commissures are positioned away from and do not block the coronary arteries (e.g., to reduce the likelihood blocking coronary access during subsequent interventional procedures). Specifically, the delivery apparatus 100 can be configured to control the rotational positioning of the prosthetic heart valve relative to the native valve, to achieve the commissure alignment, thereby increasing access to the coronary arteries. Additionally, this positioning of the prosthetic heart valve can facilitate a later, leaflet cutting procedure that provides increased access to the coronary arteries.

[0128] Further details on methods of aligning commissures of native valve with commissures of prosthetic valve after deploying the prosthetic valve are described in PCT Patent Application Publication No. WO 2022 / 046585, which is incorporated by reference herein in its entirety.

[0129] As introduced above, the apparatus and methods disclosed herein can enable implantation of an expandable prosthetic heart valve (for example, the prosthetic valve 50 of FIGS. 1A and IB and / or other prosthetic valves), or another type of expandable prosthetic medical device (such as a stent) at a selected implantation configuration. In some examples, the apparatus and methods disclosed herein can enable implantation of an expandable prosthetic heart valve in a selected one of a flared implantation configuration, a parallel implantation configuration, or a tapered implantation configuration depending on, for example, one or more characteristics of an implantation location. For example, FIGS. 3A-3C show exemplary schematic illustrations of an implantation of a prosthetic heart valve 250, which can have one or more of the features discussed herein with reference to the prosthetic heart valve 50. The prosthetic heart valve 250 can be selectively implanted in a parallel implantation configuration 202 within a first native annulus 200a (FIG. 3A), in a flared implantation configuration 204 within a second native annulus 200b (FIG. 3B), and in a tapered implantation configuration 206 within a third native annulus 202c (FIG. 3C). In theillustrated example, the first native annulus 200a has a diameter Di, the second native annulus 200b has a diameter D2 that is smaller than Di, and the third native annulus 200c has a diameter D3 that is larger than Di.

[0130] As noted above, a normal working range of a prosthetic heart valve can be defined by a minimum diameter and a maximum diameter over which sufficient opening of the leaflets and sufficient coaptation between the leaflet free edges can be maintained when the prosthetic valve is implanted in a parallel implantation configuration (that is, a configuration where inflow and outflow end portions of the prosthetic valve are radially expanded to a same diameter or a similar diameter (for example, a first diameter that is + / -1% of a second diameter)). In some examples, a normal working range of the prosthetic heart valve 250 can be 28 mm to 30 mm.

[0131] As can be seen in FIG. 3A, in some examples, in the parallel implantation configuration 202, inflow and outflow end portions of the prosthetic valve 250 can be radially expanded to a same or similar diameter and a frame 252 of the valve (which can have one or more features of the frame 52 discussed above) can be in a parallel orientation relative to a central axis A of the radially expanded prosthetic heart valve 250. For example, an inflow end 266 of the prosthetic valve can be expanded to a diameter D4 and an outflow end 268 of the prosthetic valve can be expanded to a diameter D5. In some examples, D4 is equal to D5. In some examples, D4 and D5 are similar, for example, a difference between D4 and D5 being less than 1% of whichever diameter is larger. In some examples, of the diameters D4 and D5 can be in a range of 20 mm to 32 mm. In the parallel implantation configuration 202, commissures 264 define a “commissure plane’’ (which is a plane intersecting the commissures 264 and perpendicular to the axis A) of the prosthetic valve 250 which has a diameter De.

[0132] As can be seen in FIG. 3B, in some examples, in the flared implantation configuration 204, the inflow end portion of the radially expanded prosthetic valve 250 can have a smaller diameter than its outflow end portion. For example, the inflow end 266 of the prosthetic valve can be expanded to a diameter D7 and the outflow end 268 of the prosthetic valve can be expanded to a diameter Ds, where D7 is less than Ds. In some examples, D7 can be at least 1% less than Ds, at least 2% less than Ds, at least 3% less than Ds, at least 4% less than Ds, at least 5% less than Ds, or greater than 5% less than D$. In the flared implantation configuration 204, the commissure plane 264 has a diameter De (indicated in dashed line), which can be equal or similar to the diameter De in the parallel implantation configuration 202.

[0133] In some examples, at least a portion of the sides of the frame 252 of the valve (in cross-section) can be angled, in an inflow to outflow direction, away from a central axis A of the radially expanded prosthetic heart valve. In some examples, in the flared implantation configuration, the sides of the frame (extending from an inflow end to an outflow end of the frame) can be disposed at a constant or substantially constant angle relative to the central axis (as shown in FIG. 3B). In some examples, a first portion of the sides of the frame of the valve can be in a parallel orientation relative to the central axis and a second portion the sides of the frame can be angled, in an inflow to outflow direction, away from the central axis of the radially expanded prosthetic heart valve (see, for example, FIGS. 9A and 11 A).

[0134] As can be seen in FIG. 3C, in some examples, in the tapered implantation configuration 206, the inflow end portion of the radially expanded prosthetic valve 250 can have a greater diameter than its outflow end portion. For example, an inflow end 266 of the prosthetic valve can be expanded to a diameter D9 and an outflow end 268 of the prosthetic valve can be expanded to a diameter Dio, wherein D9 is greater than Dio. In some examples, Dio can be at least 1% less than D9, at least 2% less than D9, at least 3% less than D9. at least 4% less than D9, at least 5% less than D9, or greater than 5% less than D9. In the tapered implantation configuration 206, the commissure plane 264 has a diameter De (indicated in dashed line), which can be equal or similar to the diameters De in the parallel implantation configuration 202 and the flared configuration 204.

[0135] In some examples, in the tapered implantation configuration, at least a portion of the sides of the frame 252 of the valve (in cross-section) can be angled, in an inflow to outflow direction, toward a central axis of the radially expanded prosthetic heart valve. In some examples, an entirety of the sides of the frame (extending from an inflow end to an outflow end of the frame) can be disposed at a constant or substantially constant angle relative to the central axis (as shown in FIG. 3C). In some examples, a first portion of the sides of the frame of the valve can be in a parallel orientation relative to the central axis and a second portion the sides of the frame can be angled, in an inflow to outflow direction, toward the central axis of the radially expanded prosthetic heart valve (see, for example, FIGS. 9B and 11B).

[0136] The diameter Di of the first native annulus 200a is within the normal working range of the prosthetic valve 250, however, the diameter D2 of the second native annulus 200b is below the minimum diameter of the normal working range and the diameter D3 of the third native annulus 200c is above the maximum diameter of the normal working range. Implantation of the prosthetic heart valve 250 in the flared configuration 204 enables the valve 250 to be implanted at the native annulus 200b (which is below the normal workingrange) as the diameter Dr, at the commissure plane 264 is the same or similar to the diameter De of the commissural plane when the prosthetic valve is implanted in the parallel configuration 202. Implantation of the prosthetic heart valve 250 in the tapered configuration 206 can enable the valve 250 to be implanted at the native annulus 200c (which is above the normal working range) as the diameter De at the commissure plane 264 is the same or similar to the diameter De of the commissural plane when the prosthetic valve is implanted in the parallel configuration 202. In some examples, the diameter Deis a diameter which allows sufficient opening of the leaflets and sufficient coaptation between the leaflet free edges for regulating blood flow through the prosthetic valve 250. Accordingly, a functional working range of the prosthetic valve can be increased relative the normal working range of the prosthetic valve. In some examples, the functional working range can be defined by a minimum diameter (when the prosthetic valve is implanted in a flared implantation configuration) and a maximum diameter (when the prosthetic valve is implanted in a tapered implantation configuration) over which sufficient opening of the leaflets and sufficient coaptation between the leaflet free edges can be maintained.

[0137] In some examples, a delivery apparatus and / or a delivery assembly can include balloons of different shapes for radially expanding prosthetic valves to desired or selected implantation configuration (for example, a parallel implantation configuration, a tapered implantation configuration, or a flared implantation configuration). FIGS. 4A-4C are schematic illustrations of balloons 218a, 218b, 218c, which can be utilized for expanding the prosthetic valve 250 to the parallel, flared, and tapered implantation configurations 202, 204, 206, respectively (shown in FIGS. 3A-3B and 5A-5C).

[0138] In some examples, the balloons 218a, 218b, 218c can have one or more features of the balloon 118 discussed herein. In some examples, each of the balloons 218a, 218b, 218c can be a component of a delivery apparatus, such as, for example the delivery apparatus 100 discussed herein and illustrated in FIGS. 2A and 2B. In some examples, the balloons 218a, 218b, 218c each include proximal end, distal end, and intermediate portions similar to the distal end portion (or section) 132, the proximal end portion (or section) 133, and the intermediate portion (or section) 135, wherein the intermediate portion (also referred to herein a working portion of the balloon) and a valve mounting portion of the delivery apparatus are configured to receive a radially compressed prosthetic valve. In some examples, a proximal end of the prosthetic valve is radially compressed around a proximal end of the intermediate portion of the balloon, and a distal end of the prosthetic valve is radially compressed around a distal end of the intermediate portion of the balloon.

[0139] FIG. 4A shows a parallel balloon 218a including a proximal end portion 233a, a distal end portion 232a and an intermediate (working) portion 235a disposed therebetween. The parallel balloon can be shaped to have a parallel inflation configuration in which a distal end 234a of the intermediate portion 235a is expanded to a diameter Du and a proximal end 236a of the intermediate portion 235a is expanded to a diameter Dn, which is the same or similar to the diameter Du. In some examples, the diameters Du and D12 can be in a range of 20 mm to 32 mm. In some examples, the parallel balloon can be shaped such that, in the parallel inflation configuration, a wall of the balloon 218a in the intermediate portion 235a is in a parallel orientation relative to a central axis B of the inflated balloon. Inflation of the parallel balloon 218a can result in deployment of the prosthetic valve 250 and radial expansion of the prosthetic valve 250 to the parallel implantation configuration 202 shown in FIGS. 3 A and 5A.

[0140] FIG. 4B shows a flared balloon 218b including a proximal end portion 233b, a distal end portion 232b and an intermediate portion 235b disposed therebetween. The intermediate portion 235b in the illustrated example includes a cylindrical section 270 and a flared distal section 272. The flared balloon 218b can be shaped to have a flared inflation configuration in which a distal end 234b of the intermediate portion 235b is expanded to a diameter D13 and a proximal end 236b of the intermediate portion 235b is expanded to a diameter D14, which is greater than the diameter D13. In some examples, the diameter D14 can be in a range of 20 mm to 32 mm and the diameter D13 can be in a range of 1% to 5% less than D14. In some examples, D1 can be at least 1% less than D14, at least 2% less than D14, at least 3% less than D14, at least 4% less than D14, at least 5% less than D14, or greater than 5% less than D14. In some examples, the flared balloon can be shaped such that, in the flared inflation configuration, a portion 238b of a wall of the balloon in the intermediate portion 235b extending from the distal end 234b in a distal to proximal direction is angled away from a central axis B of the inflated balloon at least partially along the length of the intermediate portion. For example, if the cylindrical portion is present, the balloon is flared along the distal section 272 and can have a constant diameter along the cylindrical section 270. In some examples, the balloon can be flared continuously from the distal end 234b to the proximal end 236b (for example, as shown in FIG. 6B). Inflation of the flared balloon 218b can result in deployment of the prosthetic valve 250 and radial expansion of the prosthetic valve 250 to the flared implantation configuration 204 shown in FIGS. 3B and 5B.

[0141] FIG. 4C shows a tapered balloon 218c including a proximal end portion 233c, a distal end portion 232c and an intermediate portion 235c disposed therebetween. The intermediateportion 235c in the illustrated example includes a cylindrical section 274 and a tapered proximal section 276. The tapered balloon 218c can be shaped to have a tapered inflation configuration in which a distal end 234c of the intermediate portion 235c is expanded to a diameter D15 and a proximal end 236c of the intermediate portion 235c is expanded to a diameter Die, which is less than the diameter Dis. In some examples, the diameter Dis can be in a range of 20 mm to 32 mm and the diameter Die can be in a range of in a range of 1% to 5% less than Dis. In some examples, Die can be at least 1% less than Dis, at least 2% less than Dis, at least 3% less than Dis, at least 4% less than Dis, at least 5% less than Dis, or greater than 5% less than Dis. In some examples, the tapered balloon can be shaped such that, in the tapered inflation configuration, a portion 238c of a wall of the balloon in the intermediate portion 235b extending from the proximal end 236b in a proximal to distal direction is angled away from a central axis B of the inflated balloon at least partially along the length of the intermediate portion. For example, if the cylindrical portion 274 is present, the balloon is tapered along the proximal section 276 and can have a constant diameter along the cylindrical section 274. In some examples, the balloon can be tapered continuously from the proximal end 236b to the distal end 234c (for example, as shown in FIG. 6C). Inflation of the tapered balloon 218c can result in deployment of the prosthetic valve 250 and radial expansion of the prosthetic valve 250 to the tapered implantation configuration 206 shown in FIGS. 3C and 5C.

[0142] In some examples, parallel, flared, and tapered balloons can have other configurations. For example, FIGS. 6A-6C are schematic illustrations of balloons 318a, 318b, 318c, which can be utilized for expanding a prosthetic valve 350 to parallel, flared, and tapered implantation configurations 302, 304, 306, respectively, shown in FIGS. 7A-7B. The prosthetic valve 350 can have one or more of the features of the prosthetic valves 50, 250 discussed herein, and the parallel, flared, and tapered implantation configurations 302, 304, 306 can be similar to the parallel, flared, and tapered implantation configurations 202, 204, 206 described herein for the prosthetic valve 250. In some examples, the balloons 318a, 318b, 318c can have one or more features of the balloon 118 discussed herein. In some examples, each of the balloons 318a, 318b, 318c can be a component of a delivery apparatus, such as, for example the delivery apparatus 100 discussed herein and illustrated in FIGS. 2A and 2B. In some examples, the balloons 318a, 318b, 318c each include proximal end, distal end, and intermediate portions similar to the distal end portion (or section) 132, the proximal end portion (or section) 133, and the intermediate portion (or section) 135, wherein the intermediate portion and a valve mounting portion of the delivery apparatus are configured toreceive a radially compressed prosthetic valve. In some examples, a proximal end of the prosthetic valve is radially compressed around a proximal end of the intermediate portion of the balloon, and a distal end of the prosthetic valve is radially compressed around a distal end of the intermediate portion of the balloon.

[0143] FIG. 6A shows a parallel balloon 318a including a proximal end portion 333a, a distal end portion 332a and an intermediate portion 335a disposed therebetween. The parallel balloon can be shaped to have a parallel inflation configuration in which a distal end 334a of the intermediate portion 335a is expanded to a diameter D17 and a proximal end 336a of the intermediate portion 335a is expanded to a diameter Dis, which is the same or similar to the diameter Dp. In some examples, the diameters D17 and Dis can be in a range of 20 mm to 32 mm. In some examples, the parallel balloon can be shaped such that, in the parallel inflation configuration, a wall of the balloon 318a in the intermediate portion 335a is in a parallel orientation relative to a central axis C of the inflated balloon. Inflation of the parallel balloon 318a can result in deployment of the prosthetic valve 350 and radial expansion of the prosthetic valve 350 to the parallel implantation configuration 302 shown in FIG. 7A (wherein inflow and outflow end portions 366, 368 are expanded to same or similar diameters).

[0144] FIG. 6B shows a flared balloon 318b including a proximal end portion 333b, a distal end portion 332b and an intermediate portion 335b disposed therebetween. The flared balloon 318b can be shaped to have a flared inflation configuration in which a distal end 334b of the intermediate portion 335b is expanded to a diameter D19 and a proximal end 336b of the intermediate portion 335b is expanded to a diameter D20, which is greater than the diameter D19. In some examples, the diameter D20 can be in a range of 20 mm to 32 mm and the diameter D19 in a range of 1% to 5% less than D20. In some examples, D19 can be at least 1% less than D20, at least 2% less than D20, at least 3% less than D20, at least 4% less than D20, at least 5% less than D20, or greater than 5% less than D20. In some examples, the flared balloon can be shaped such that, in the flared inflation configuration, a wall of the balloon in the intermediate portion 335b (for example, an entirety of the balloon wall in the intermediate portion) is angled away from a central axis C of the inflated balloon in a distal to proximal direction. Inflation of the flared balloon 318b can result in deployment of the prosthetic valve 350 and radial expansion of the prosthetic valve 350 to the flared implantation configuration 304 shown in FIG. 7B (wherein the inflow end portion 366 is expanded to a smaller diameter than the outflow end portion 368).

[0145] FIG. 6C shows a tapered balloon 318c including a proximal end portion 333c, a distal end portion 332c and an intermediate portion 335c disposed therebetween. The tapered balloon 318c can be shaped to have a tapered inflation configuration in which a distal end 334c of the intermediate portion 335c is expanded to a diameter D21 and a proximal end 336c of the intermediate portion 335c is expanded to a diameter D22, which is less than the diameter D21. In some examples, the diameter D21 can be in a range of 20 mm to 32 mm and the diameter D22 can be in a range of 1% to 5% less than D21. In some examples, D22 can be at least 1 % less than D21, at least 2% less than D21, at least 3% less than D21, at least 4% less than D21, at least 5% less than D21, or greater than 5% less than D21. In some examples, the tapered balloon can be shaped such that, in the tapered inflation configuration, a wall of the balloon in the intermediate portion 335b (for example, an entirety of the balloon wall in the intermediate portion) is angled toward a central axis C of the inflated balloon in a distal to proximal direction. Inflation of the tapered balloon 318c can result in deployment of the prosthetic valve 350 and radial expansion of the prosthetic valve 350 to the tapered implantation configuration 306 shown in FIG. 7C (wherein the inflow end portion 366 is expanded to a greater diameter than the outflow end portion 368).

[0146] FIGS. 8A-8B and 10A-10B show additional exemplary balloon configurations. FIGS. 8A and 10A show exemplary flared balloons 418b, 518b that can be utilized for deployment of a prosthetic valve and implantation at a flared implantation configuration. FIGS. 8B and 10B show exemplary tapered balloons 418c, 518c that can be utilized for deployment of a prosthetic valve and implantation at a tapered implantation configuration.

[0147] The balloons 418b, 418c can be similar to the balloons 218b, 218c shown in FIGS. 4B and 4C discussed herein. For example, the flared balloon 418b can include a proximal end portion 433b, a distal end portion 432b, and an intermediate portion 435b disposed therebetween. The intermediate portion 435b comprises a first section 440b (which can be cylindrical) and a second, angled section 438b (also referred to herein as a “flared distal section’’). The flared balloon 418b can be shaped to have a flared inflation configuration in which a proximal end 436b of the intermediate portion 435b has a greater diameter than a distal end 434b of the intermediate portion 435b. In some examples, the flared balloon 418b can have the diameter D« at the distal end 434b and the D14 at the proximal end 436b (discussed herein with reference to FIG. 4B). As can be seen in FIG. 8A, the flared distal section 438b of a wall of the balloon in the intermediate portion 435b extending from the distal end 434b in a distal to proximal direction can angle away from a central axis D of theinflated balloon. In some examples, the wall of the balloon along the first section 440b of the intermediate portion 435b can be parallel to the central axis D of the inflated balloon.

[0148] Although illustrated in two-dimensions, in three-dimensional space, the flared distal section 438b of the balloon wall can form a frustoconical portion of the balloon 418b. A minimum diameter of the flared distal section 438b can be defined by the distal end 434b of the intermediate portion 435b. A maximum diameter of the flared distal section 438b can be located at an intersection 442b between the flared distal section 438b and the first section 440b of the intermediate portion 435b. The intersection 442b can form an angle a that is greater than 180° (for example, the angle a can be in a range of 181° to 270°).

[0149] As shown in FIG. 8A, in an axial direction, there is a distance di between the distal end 434b of the intermediate section 435b and the intersection 442b. In a direction perpendicular to the central axis D of the inflated balloon, there is a distance d2 between the distal end 434b of the intermediate section 435b and the intersection 442b. In some examples, the distance di is at least 0.1 mm, and in some examples, is in the range of 0.1 mm to 20 mm. In some examples, the distance di is at least 1 mm but less than the total length of the intermediate portion 435b. In some examples, the distance d2 is at least 0.1 mm. In some examples, the distance d2 is at least 0.1 mm but less than 25% of the maximum outer diameter of the intermediate portion 435b.

[0150] In some examples, inflation of the flared balloon 418b can result radial expansion of a prosthetic valve to the flared implantation configuration 204 shown in FIGS. 3B and 5B and / or the flared implantation configuration 304 shown in FIG. 7B. In some examples, inflation of the flared balloon 418b can result in radial expansion of a prosthetic valve to other flared implantation configurations. For example, FIG. 9A illustrates the prosthetic valve 250 in a flared implantation configuration 404 that can be achieved by radially expanding the prosthetic valve 250 utilizing the balloon 418b. As can be seen therein, in the flared implantation configuration 404, a first portion 252a of the sides of the frame 252 of the valve can be in a parallel orientation relative to the central axis A of the valve and a second portion 252b the sides of the frame 252 can be angled, in an inflow to outflow direction, away from the central axis A of the radially expanded prosthetic heart valve 250. In the flared implantation configuration 404, the second (angled) portion 252b of the frame 252 can be located at an inflow end portion of the prosthetic valve 250 extending from the inflow end 266, and the first (cylindrical) portion 252a of the frame 252 can extend from the second (angled) portion 252b to the outflow end 268 of the prosthetic valve 250. In some examples, the inflow end 266 of the prosthetic valve 250 can be expanded to the diameter D7 and theoutflow end 268 of the prosthetic valve can be expanded to the diameter D«, as discussed herein with reference to FIG. 3B.

[0151] In some examples, the tapered balloon 418c can have an inverted shape relative to the flared balloon 418b. As shown in FIG. 8B, similar to the tapered balloon 218c, the tapered balloon 418c can include a proximal end portion 433c, a distal end portion 432c, and an intermediate portion 435c disposed therebetween. The intermediate portion 435c comprises a first section 440c (which can be cylindrical) and a second, angled section 438c (also referred to herein as a “tapered proximal section”). The tapered balloon 418c can be shaped to have a tapered inflation configuration in which a distal end 434c of the intermediate portion 435c has a greater diameter than a proximal end 436c of the intermediate portion 435c. In some examples, the tapered balloon 418c can have the diameter Dis at the distal end 434c and the diameter Di6 at the proximal end 436c (discussed herein with reference to FIG. 4C). As can be seen in FIG. 8B, the tapered proximal section 438c of the balloon in the intermediate portion 435c extending from the proximal end 436c in a proximal to distal direction can angle away from a central axis D of the inflated balloon. In some examples, the first section 440c of the intermediate portion 435c can be parallel to the central axis D of the inflated balloon.

[0152] In three-dimensional space, the tapered proximal section 438c of the balloon wall can form a frustoconical portion of the balloon 418c. A minimum diameter of the tapered proximal section 438c can be defined by the proximal end 436c of the intermediate portion 435c. A maximum diameter of the tapered proximal section 438c of the balloon 418c can be formed at an intersection 442c between the tapered proximal section 438c and the first section 440c of the intermediate portion 435c. The intersection 442c can have an angle b that is greater than 180° (for example, the angle b can be in a range of 181° to 270°).

[0153] As shown in FIG. 8B, in an axial direction, there is a distance ds between the proximal end 436b of the intermediate portion 435c and the intersection 442c. In a direction perpendicular to the central axis D of the inflated balloon, there is a distance dr between the proximal end 436c of the intermediate portion 435c and the intersection 442c. In some examples, the distance ds is at least 0. 1 mm, and in some examples, is in the range of 0.1 mm to 20 mm. In some examples, the distance ds is at least 1 mm but less than the total length of the intermediate portion 435c. In some examples, the distance dr is at least 0.1 mm. In some examples, the distance dr is at least 0.1 mm but less than 25% of the maximum outer diameter of the intermediate portion 435c.

[0154] In some examples, the tapered proximal section 438c can be configured to accommodate leaflet material forming the commissures of a prosthetic valve mounted aroundthe tapered balloon 418c. In some examples, the distance di can be equal to or greater than a height of the commissures of a prosthetic valve that is radially compressed around the balloon 418b. In some examples, the distance dr can be equal to or greater than a depth or thickness of the commissures of a prosthetic valve that is radially compressed around the balloon 418b. When a prosthetic valve (e.g., prosthetic valve 50) is radially compressed around an uninflated balloon 418c for delivery into a subject’s body, the prosthetic valve is disposed on the intermediate portion 435c with the commissures of the prosthetic valve (e.g., commissures 64) overlying the proximal section 438c.

[0155] In some examples, inflation of the tapered balloon 418c can result in radial expansion of a prosthetic valve to the tapered implantation configuration 206 shown in FIGS. 3C and 5C and / or the tapered implantation configuration 306 shown in FIG. 7C. In some examples, inflation of the tapered balloon 418c can result radial expansion of a prosthetic valve to other tapered implantation configurations. For example, FIG. 9B illustrates the prosthetic valve 250 in a tapered implantation configuration 406 that can be achieved by radially expanding the prosthetic valve 250 utilizing the balloon 418c. As can be seen therein, in the tapered implantation configuration 406, a first portion 252a of the sides of the frame 252 of the valve can be in a parallel orientation relative to the central axis A of the valve and a second portion 252b the sides of the frame 252 can be angled, in an inflow to outflow direction, toward the central axis A of the radially expanded prosthetic heart valve 250. In the tapered implantation configuration 406, the second (angled) portion 252b of the frame 252 can be located at an outflow end portion of the prosthetic valve 250 extending from the outflow end 268, and the first (cylindrical) portion 252a of the frame 252 can extend from the second (angled) portion 252b to the inflow end 266 of the prosthetic valve 250. In some examples, the inflow end 266 of the prosthetic valve 250 can be expanded to the diameter D9 and the outflow end 268 of the prosthetic valve can be expanded to a diameter Dio, as discussed herein with reference to FIG. 3C.

[0156] Turning to FIG. 10A, the flared balloon 518b can include a proximal end portion 533b, a distal end portion 532b, and an intermediate portion 535b disposed therebetween. The intermediate portion 535b in the illustrated example comprises a first, distal section 540b (which can be cylindrical) and a second, proximal flared section 538b. The flared balloon 518b can be shaped to have a flared inflation configuration in which a proximal end 536b of the intermediate portion 535b has a greater diameter than a distal end 534b of the intermediate portion 535b. In some examples, the flared balloon 518b can have the diameter D13 at the distal end 534b and the D14 at the proximal end 536b (FIG. 4B). In some examples,the first, distal section 540b of the intermediate portion 535b can be parallel to a central axis E of the inflated balloon.

[0157] In three-dimensional space, the proximal flared section 538b of the balloon wall can form a frustoconical portion of the balloon 518b. A maximum diameter of the proximal flared section 538b can be defined by the proximal end 536b of the intermediate portion 535b. A minimum diameter of the proximal flared section 538b can be formed at an intersection 542b between the proximal flared section 538b and the first section 540b of the intermediate portion 535b. The intersection 542b can have an angle c that is less than 180 degrees (for example, the angle c can be in a range of 90° to 179°).

[0158] As shown in FIG. 10A, in an axial direction, there is a distance ds between the proximal end 536b of the intermediate portion 535b and the intersection 542b. In a direction perpendicular to the central axis E of the inflated balloon, there is a distance d6 between the proximal end 536b of the intermediate portion 535b and the intersection 542b. In some examples, the distance ds is at least 0.1 mm, and in some examples, is in the range of 0.1 mm to 20 mm. In some examples, the distance de is at least 0.1 mm. In some examples, the distance de is at least 0.1 mm but less than 25% of the maximum outer diameter of the intermediate portion 535b.

[0159] In some examples, inflation of the flared balloon 518b can result in radial expansion of a prosthetic valve to the flared implantation configuration 204 shown in FIGS. 3B and 5B and / or the flared implantation configuration 304 shown in FIG. 7B. In some examples, inflation of the flared balloon 518b can result in radial expansion of a prosthetic valve to other flared implantation configurations. For example, FIG. 11 A illustrates the prosthetic valve 250 in a flared implantation configuration 504 that can be achieved by radially expanding the prosthetic valve 250 utilizing the balloon 518b. As can be seen therein, in the flared implantation configuration 504, a first portion 252a of the sides of the frame 252 of the valve can be in a parallel orientation relative to the central axis A of the valve and a second portion 252b the sides of the frame 252 can be angled, in an inflow to outflow direction, away from the central axis A of the radially expanded prosthetic heart valve 250. In the flared implantation configuration 504, the second (angled) portion 252b of the frame 252 can be located at an outflow end portion of the prosthetic valve 250 extending from the outflow end 268, and the first (cylindrical) portion 252a of the frame 252 can extend from the second (angled) portion 252b to the inflow end 266 of the prosthetic valve 250. In some examples, the inflow end 266 of the prosthetic valve 250 can be expanded to the diameter D? and theoutflow end 268 of the prosthetic valve can be expanded to the diameter Ds, as discussed herein with reference to FIG. 3B.

[0160] In some examples, the tapered balloon 518c can have an inverted shape relative to the flared balloon 518b. As can be seen in FIG. 10B, the tapered balloon 518c can include a proximal end portion 533c, a distal end portion 532c, and an intermediate portion 535c disposed therebetween. The intermediate portion 535c comprises a first section 540c (which can be cylindrical) and a second, tapered distal section 538c. The tapered balloon 518c can be shaped to have a tapered inflation configuration in which a distal end 534c of the intermediate portion 535c has a greater diameter than a proximal end 536c of the intermediate portion 535c. In some examples, the tapered balloon 518c can have the diameter Dis at the distal end 534c and the Die at the proximal end 536c (described herein with reference to FIG. 4C). In some examples, the first section 540c of the intermediate portion 535c can be parallel to the central axis E of the inflated balloon. In some examples, a tapered distal section 538c of the intermediate portion 535c extending from the distal end 534c in a distal to proximal direction can angled toward the central axis E of the inflated balloon.

[0161] In a three-dimensional representation, the tapered distal section 538c of the balloon wall can form a frustoconical portion of the balloon 518c. A maximum diameter of the tapered distal section 538c can be defined by the distal end 534c of the intermediate portion 535c. A minimum diameter of the tapered distal section 538c can be formed at an intersection 542c between the tapered distal section 538c and the first section 540c of the intermediate portion 535c. The intersection 542b can have an angle d that is less than 180 degrees (for example, the angle d can be in a range of 90° to 179°).

[0162] As shown in FIG. 8D, in an axial direction, there is a distance d? between the distal end 534c of the intermediate portion 535c and the intersection 542c. In a direction perpendicular to the central axis E of the inflated balloon, there is a distance ds between the distal end 534c of the intermediate portion 535c and the intersection 542c. In some examples, the distance d? is at least 0.1 mm, and in some examples, is in the range of 0.1 mm to 20 mm. In some examples, the distance ds is at least 0.1 mm. In some examples, the distance ds is at least 0. 1 mm but less than 25% of the maximum outer diameter of the intermediate portion 535c.

[0163] In some examples, inflation of the tapered balloon 518c can result in radial expansion of a prosthetic valve to the tapered implantation configuration 206 shown in FIGS. 3C and 5C and / or the tapered implantation configuration 306 shown in FIG. 7C. In some examples, inflation of the tapered balloon 518c can result radial expansion of a prosthetic valve to othertapered implantation configurations. For example, FIG. 1 IB illustrates the prosthetic valve 250 in a tapered implantation configuration 506 that can be achieved by radially expanding the prosthetic valve 250 utilizing the balloon 518c. As can be seen therein, in the tapered implantation configuration 506, a first portion 252a of the sides of the frame 252 of the valve can be in a parallel orientation relative to the central axis A of the valve and a second portion 252b the sides of the frame 252 can be angled, in an inflow to outflow direction, toward the central axis A of the radially expanded prosthetic heart valve 250. In the tapered implantation configuration 506, the second (angled) portion 252b of the frame 252 can be located at an inflow end portion of the prosthetic valve 250 extending from the inflow end 266, and the first (cylindrical) portion 252a of the frame 252 can extend from the second (angled) portion 252b to the outflow end 268 of the prosthetic valve 250. In some examples, the inflow end 266 of the prosthetic valve 250 can be expanded to the diameter D9 and the outflow end 268 of the prosthetic valve can be expanded to a diameter Dio, as discussed herein with reference to FIG. 3C.

[0164] As discussed herein, utilizing the delivery apparatus and the balloons disclosed herein, a functional working range of a prosthetic valve can be increased relative to a normal working range of the prosthetic valve. In some examples, extending the functional working range of a prosthetic valve enables use of the valve across a broader range of native annulus sizes. FIG. 12 is a schematic illustration of implantation of the prosthetic valve 250 in native annuluses of a range of sizes (similar to the schematic illustrations shown in FIGS. 3A-3C discussed herein). In some examples, the prosthetic valve 250 can have a functional working range 600 that is greater than a normal working range 602 of the prosthetic valve. In some examples, an extended lower range 604 of the functional working range 600 can be below the minimum diameter of the normal working range 602. In some examples, an extended upper range 606 of the functional working range 600 can be above the maximum diameter of the normal range 602. In some examples, the difference between the smallest and largest diameters of the normal working range can be about 2 mm; the smallest diameter of the extended lower range can be about 1 to 1.5 mm smaller than the smallest diameter of the normal working range: and the largest diameter of the extended upper range can be about 0.5 to 1 mm larger than the largest diameter of the normal working range. In some examples, the normal working range can be 28 mm to 30 mm. In some examples, the extended lower range 604 can be 27.5 mm to 27.9 mm. In some examples, the extended upper range 606 can be 30.1 mm to 30.5 mm.

[0165] In some examples, the prosthetic valve 250 can be implanted in a parallel configuration 202 at annuluses 200a', 200a", 200a'" having sizes (for example, diameters) that are within the normal working range 602. For example, the prosthetic valve 250 can be implanted in a parallel configuration 202" in a native annulus 200a", can be implanted in a parallel configuration 202' in a native annulus 200a' that is smaller than the native annulus 200a", and can be implanted in a parallel configuration 202'" in a native annulus 200a'" that is larger than the native annulus 200a". In some examples, at a native annulus 200b having a size (for example, a diameter) below the minimum diameter of the normal working range, the prosthetic valve 250 can be implanted in the flared configuration 204. In some examples, at a native annulus 200c having a size (for example, a diameter) above the maximum diameter of the normal working range, the prosthetic valve 250 can be implanted in the tapered configuration 206.

[0166] In some examples, a flared balloon can be used to implant the prosthetic valve 250 in the flared configuration 204; a parallel balloon can be used to implant the prosthetic valve 250 in the parallel configurations 200a', 200a", 200a'"; and a tapered balloon can be used to implant the prosthetic valve 250 in the tapered configuration 206.

[0167] In some examples, the arrangement or the space occupied by the soft components inside the frame of the valve (e.g., the leaflets and / or inner skirt) can cause one end of the frame to expand to a slightly greater diameter than the other end. For example, the arrangement of the commissures adjacent the outflow end of the frame can cause the outflow end of the frame to expand slightly greater than the inflow end of the frame when the prosthetic valve is expanded with a parallel balloon. In such examples, a tapered balloon can be used to deploy the prosthetic valve to a parallel configuration near the upper end of the normal working range 602, such as the parallel configuration 202'".

[0168] In some examples, a set of delivery apparatuses (for example, delivery apparatuses similar to the delivery apparatus 100 discussed herein) including a delivery apparatus with a parallel balloon, a delivery apparatus with a flared balloon, and a delivery apparatus with a tapered balloon can be utilized to implant a prosthetic valve (such as the prosthetic valves 50, 250, 350) at a desired or selected implantation configuration (for example, a selected one of a parallel configuration 202, 302, a flared configuration 204, 304, or a tapered configuration 206, 306) based on one or more characteristics of a target implantation site (such as, for example, a diameter of a native annulus). In some examples, a set of delivery apparatuses including a delivery apparatus with a parallel balloon, a delivery apparatus with a flared balloon, and a delivery apparatus with a tapered balloon can be utilized for post-implantationadjustment of an implanted prosthetic valve (such as the prosthetic valves 50, 250, 350) to a desired or selected implantation configuration (for example, a selected one of a parallel configuration 202, 302, a flared configuration 204, 304, or a tapered configuration 206, 306) based on one or more characteristics of the implanted prosthetic valve (such as, for example, insufficient opening or insufficient coaptation of the leaflets of the implanted prosthetic valve) and / or one or more characteristics of a target implantation site (such as, for example, a diameter of a native annulus).

[0169] In some examples, a set of delivery apparatuses can include fewer delivery apparatus (for example, a delivery apparatus with a parallel balloon and a delivery apparatus with a flared balloon, or a delivery apparatus with a parallel balloon and a delivery apparatus with a tapered balloon). In some examples, each of a flared balloon and a tapered balloon can have a similar configuration and can be flared or tapered depending on the orientation in which it is coupled to a balloon shaft of the delivery apparatus (for example, depending on whether the wider end portion is disposed distal of the narrower end portion (tapered) or proximal of the narrower end portion (flared)). In some examples, a set of delivery apparatuses can includes additional delivery apparatus (for example, delivery apparatuses with flared balloons having different configurations, such as the flared balloons 218b, 318b, 418b, 518b, and / or delivery apparatuses with tapered balloons having different configurations, such as the tapered balloons 218c, 318c, 418c, 518c). In some examples, a prosthetic valve can be crimped onto a valve mounting portion of a selected delivery apparatus after it is selected from the set. In some examples, a delivery apparatus in a set of delivery apparatuses can have a prosthetic valve pre-mounted thereon.

[0170] FIGS. 13-15 illustrate exemplary methods of implanting and / or adjusting a prosthetic valve utilizing the delivery apparatuses including the balloons disclosed herein. FIG. 13 shows an exemplary generalized method 1000, while FIGS. 14 and 15 show exemplary methods for implantation of the prosthetic valve (method 1100) and adjustment of a previously implanted prosthetic valve (1200). As shown in FIG. 13, the exemplary method 1000 includes analyzing a target implantation site within a subject (step 1002) and determining a target deployment diameter and / or a target deployment shape for a prosthetic valve based on the analysis (step 1004). The method 1000 can further include selecting a delivery apparatus including a balloon configuration to achieve the desired diameter and / or implantation configuration (step 1006) and utilizing the selected delivery apparatus for implantation of a prosthetic valve or for adjustment of a previously implanted prosthetic valve (step 1008).

[0171] FIG. 14 shows the exemplary method 1100 for implantation of a prosthetic heart valve utilizing delivery apparatuses including the balloons disclosed herein. In some examples, the method 1100 can include the steps 1002 and 1004 shown in FIG. 13. For example, one or more characteristics of an anatomical structure within which the prosthetic valve will be implanted (such as, for example, a diameter of a native annulus, a disease condition of a native annulus, anatomy surrounding the target location, etc.) and / or one or more characteristics of a previously implanted prosthetic valve at in which a replacement prosthetic valve will be implanted (such as, for example, an implantation diameter of the previously implanted valve, an implantation configuration of the previously implanted valve, anatomy surrounding the previously implanted valve, etc.) can be analyzed for determining a target deployment diameter and / or a target implantation configuration for the prosthetic valve. At step 1102, the method 1 100 can include determining whether the target deployment diameter is within a normal working range of the prosthetic valve, below the normal working range of the prosthetic valve (which can also be referred to as “under-deployment”), or above the normal working range of the prosthetic valve (which can also be referred to as “overdeployment”). In some examples, step 1102 can additionally or alternatively include determining whether the prosthetic valve will be implanted in a parallel implantation configuration, a flared implantation configuration, or a tapered implantation configuration.

[0172] If it is determined that the prosthetic valve will be implanted below the normal working range of the prosthetic valve (for example, under-deployed) and / or that the prosthetic valve should be implanted in a flared implantation configuration, the method 1100 further includes selecting a delivery apparatus including a flared balloon (step 1104). If it is determined that the prosthetic valve will be implanted within the normal working range of the prosthetic valve and / or that the prosthetic valve should be implanted in a parallel implantation configuration, the method 1100 further includes selecting a delivery apparatus including a parallel balloon (step 1106). If it is determined that the prosthetic valve will be implanted above the normal working range of the prosthetic valve (for example, overdeployed) and / or that the prosthetic valve should be implanted in a tapered implantation configuration, the method 1100 further includes selecting a delivery apparatus including a tapered balloon (step 1 108).

[0173] In some examples, a prosthetic heart valve can be mounted over a valve mounting portion a shaft of the delivery apparatus and an intermediate portion of the balloon (step 1110). For example, a prosthetic valve can be radially compressed and crimped around the valve mounting portion and the intermediate portion of the balloon utilizing a crimpingdevice. In some examples, a prosthetic heart valve can be pre-mounted / crimped on the selected delivery apparatus. The selected delivery apparatus can be utilized to deliver the radially compressed prosthetic valve to the target implantation site (such as, for example, via the delivery techniques discussed herein) (step 11 12). Once the radially compressed prosthetic valve is positioned relative to the target implantation site, the balloon can be inflated to its inflation configuration to deploy and radially expand the prosthetic valve (step 1114). The balloon can then be deflated and withdrawn from the implanted prosthetic valve (step 11 16).

[0174] FIG. 15 shows the exemplary method 1200 for a post-implantation adjustment of a prosthetic heart valve utilizing delivery apparatuses including the balloons disclosed herein. In some examples, the method 1200 can include the steps 1002 and 1004 shown in FIG. 13. For example, one or more characteristics of the implanted prosthetic valve (such as, for example, a current implantation configuration, a current diameter, insufficiency of blood flow through the implanted prosthetic valve, leakage of blood through the valve when the leaflets of the implanted valve are in a closed position, etc.) and / or one or more characteristics of the implantation site (such as, for example, a diameter of a native annulus, a disease condition, anatomy surrounding the target location, etc.) can be analyzed for determining a target implantation diameter and / or a target implantation configuration (shape) for the implanted prosthetic valve. At step 1202, the method 1200 can include determining whether adjustment of the implantation diameter and / or the implantation configuration (shape) of the implanted prosthetic valve is needed to meet the target diameter or shape. In some examples, the step 1202 can additionally or alternatively include determining whether a diameter of an inflow end portion of the prosthetic valve and / or an outflow end potion of the prosthetic valve will be increased to meet the target implantation diameter and / or the target implantation configuration.

[0175] If it is determined that a diameter of an outflow end portion of the prosthetic valve will be increased, the method 1200 further includes selecting a delivery apparatus including a flared balloon (step 1204). If it is determined that that diameters of an outflow end portion and an inflow end portion of the prosthetic valve will be increased, the method 1200 further includes selecting a delivery apparatus including a parallel balloon (step 1206). If it is determined that an inflow end portion of the prosthetic valve will be increased, the method 1200 further includes selecting a delivery apparatus including a tapered balloon (step 1208).

[0176] In some examples, the selected delivery apparatus can be navigated to the implanted prosthetic valve (such as, for example, via methods similar to the delivery techniquesdiscussed herein) (step 1210). Once the distal end of the selected delivery apparatus having the deflated balloon mounted thereon is positioned relative to the implanted prosthetic valve, the balloon can be inflated to its inflation configuration to adjust a diameter and / or an implantation configuration of the implanted prosthetic valve (step 1210). The balloon can then be deflated and withdrawn from the implanted prosthetic valve (step 1212).

[0177] It will be appreciated that the foregoing methods are merely exemplary and methods of utilizing the delivery apparatus and balloons disclosed herein can include additional, fewer, and / or alternate steps. For example, in some examples, a selected balloon configuration can be utilized to achieve one or more different implantation configurations depending on a structure of the prosthetic valve.Delivery Techniques

[0178] For implanting a prosthetic valve having one or more integral markers within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve (for example, via alignment of the integral markers with commissures of the native valve) and radially expanded (for example, by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-stemotomy or right parasternal minithoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0179] For implanting a prosthetic valve having one or more integral markers 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 thenative mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0180] For implanting a prosthetic valve having one or more integral markers 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.

[0181] Another delivery approach is a transatrial approach whereby a prosthetic valve having one or more integral markers (mounted 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.

[0182] 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.

[0183] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethyleneoxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.

[0184] The method(s), techniques, processes, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on any suitable subject (e.g., a living subject (e.g., human, or other animal) or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, or simulator (for example, with body parts, heart, tissue, etc. being simulated), etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.Additional Examples of the Disclosed Technology

[0185] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0186] Example 1. A method comprising: determining one or more characteristics of a target implantation site; based on the one or more characteristics of the target implantation site, determining one or more of a target implantation diameter or a target implantation configuration for a prosthetic heart valve; based at least on the one or more of the target implantation diameter or the targeted implantation configuration, selecting a delivery apparatus from a set of delivery apparatuses each having a balloon with a different shape; advancing a distal end portion of the selected delivery apparatus to a native heart valve; and inflating to the balloon of the selected delivery apparatus to radially expand the prosthetic heart valve to the one or more of the targeted implantation diameter or the target implantation configuration at the target implantation site.

[0187] Example 2. The method of any example disclosed herein, particularly example 1, wherein the determining one or more characteristics of the target implantation site comprises determining at least one of a diameter of a native annulus or a diameter of a previously implanted prosthetic valve within which the prosthetic heart valve will be implanted.

[0188] Example 3. The method of any example disclosed herein, particularly example 2, wherein the determining the one or more of the target implantation diameter or the target implantation configuration for the prosthetic heart valve comprises determining the at least one of the diameter of the native annulus or the diameter of the previously implanted prosthetic valve is indicative of a size that will result in the prosthetic heart valve being deployed to a target diameter that is within a normal working range of the prosthetic heart valve; and wherein the selected delivery apparatus has a parallel balloon, wherein the parallel balloon comprises an intermediate working portion, wherein, when inflated, a diameter of a proximal end of the intermediate working portion is equal to a diameter of a distal end of the intermediate working portion.

[0189] Example 4. The method of any example disclosed herein, particularly example 2, wherein the determining the one or more of the target implantation diameter or the target implantation configuration for the prosthetic heart valve comprises determining the at least one of the diameter of the native annulus or the diameter of the previously implanted prosthetic valve is indicative of a size that will result in the prosthetic heart valve being deployed to a diameter that is below a normal working range of the prosthetic heart valve; and wherein the selected delivery apparatus has a flared balloon, wherein the flared balloon comprises an intermediate working portion, wherein, when inflated, a diameter of a proximal end of the intermediate working portion is greater than a diameter of a distal end of the intermediate working portion.

[0190] Example 5. The method of any example disclosed herein, particularly example 2, wherein the determining the one or more of the target implantation diameter or the target implantation configuration for the prosthetic heart valve comprises determining the at least one of the diameter of the native annulus or the diameter of the previously implanted prosthetic valve is indicative of a size that will result in the prosthetic heart valve being deployed to a diameter that is above a normal working range of the prosthetic heart valve; and wherein the selected delivery apparatus has a tapered balloon, wherein the tapered balloon comprises an intermediate working portion, wherein, when inflated, a diameter of a proximal end of the intermediate working portion is less than a diameter of a distal end of the intermediate working portion.

[0191] Example 6. The method of any example disclosed herein, particularly example 1, wherein the prosthetic heart valve is implanted in a native annulus, and wherein the determining one or more characteristics of the target implantation site comprises determining a deficiency in one or more of a diameter of an inflow end portion of the prosthetic heartvalve relative to a current diameter thereof or a diameter of an outflow end portion of the prosthetic heart valve relative to a current diameter thereof.

[0192] Example 7. The method of any example disclosed herein, particularly example 6, wherein the determining the one or more of the target implantation diameter or the target implantation configuration for the prosthetic heart valve comprises determining a desired increase in each of the diameter of the outflow end portion and the diameter of the inflow end portion of the prosthetic heart valve: and wherein the selected delivery apparatus has a parallel balloon, wherein the parallel balloon comprises an intermediate working portion, and wherein, when inflated, a diameter of a proximal end of the intermediate working portion is equal to a diameter of a distal end of the intermediate working portion.

[0193] Example 8. The method of any example disclosed herein, particularly example 6, wherein the determining the one or more of the target implantation diameter or the target implantation configuration for the prosthetic heart valve comprises determining a desired increase in only the diameter of the outflow end portion of the prosthetic heart valve; and wherein the selected delivery apparatus has a flared balloon, wherein the flared balloon comprises an intermediate working portion, and wherein, when inflated, a diameter of a proximal end of the intermediate working portion is greater than a diameter of a distal end of the intermediate working portion.

[0194] Example 9. The method of any example disclosed herein, particularly example 6, wherein the determining the one or more of the target implantation diameter or the target implantation configuration for the prosthetic heart valve comprises determining a desired increase in only the diameter of the inflow end portion of the prosthetic heart valve; and wherein the selected delivery apparatus has a tapered balloon, and wherein the tapered balloon comprises an intermediate working portion, wherein, when inflated, a diameter of a proximal end of the intermediate working portion is less than a diameter of a distal end of the intermediate working portion.

[0195] Example 10. A method comprising: determining a target implantation configuration for a prosthetic heart valve; based at least on the target implantation configuration, selecting a delivery apparatus from a set of delivery apparatuses, the set of delivery apparatus including a first delivery apparatus with a parallel balloon, a second delivery apparatus with a flared balloon, and a third delivery apparatus with a tapered balloon; and inflating the balloon of the selected delivery apparatus to radially expand the prosthetic heart valve to the target implantation configuration.

[0196] Example 11. The method of any example disclosed herein, particularly example 10, wherein the target implantation configuration is a parallel implantation configuration in which an outflow end portion of the prosthetic heart valve has a diameter that is equal to an inflow end portion of the prosthetic heart valve, and the selected delivery apparatus is the first delivery apparatus.

[0197] Example 12. The method of any example disclosed herein, particularly example 10, wherein the target implantation configuration is a flared implantation configuration in which an outflow end portion of the prosthetic heart valve has a greater diameter than an inflow end portion of the prosthetic heart valve, and the selected delivery apparatus is the second delivery apparatus.

[0198] Example 13. The method of any example disclosed herein, particularly example 10, wherein the target implantation configuration is a tapered implantation configuration in which an inflow end portion of the prosthetic heart valve has a greater diameter than an outflow end portion of the prosthetic heart valve, and the selected delivery apparatus is the third delivery apparatus.

[0199] Example 14. A method of implanting a prosthetic heart valve, the method comprising: identifying one or more characteristics of a target implantation site within a subject that are indicative of an implantation diameter that is lower than a minimum diameter of a normal working range of the prosthetic heart valve when implanted in a parallel implantation configuration, wherein in the parallel implantation configuration a diameter of an inflow end portion of the prosthetic heart valve is equal to a diameter of an outflow end portion of the prosthetic heart valve; selecting a delivery apparatus that includes a flared balloon coupled to a distal end portion of a shaft of the delivery apparatus; advancing the distal end portion of the shaft having the prosthetic heart valve radially compressed around the flared balloon through vasculature of the subject to the target implant site; and inflating the flared balloon to radially expand the prosthetic heart valve to a flared implantation configuration.

[0200] Example 15. The method of any example disclosed herein, particularly example 14, wherein the flared balloon comprises an intermediate working portion, and wherein, when inflated, a diameter of a proximal end of the intermediate working portion has greater than a diameter of a distal end of the intermediate working portion.

[0201] Example 16. The method of either claim 14 or claim 15, wherein, in the flared implantation configuration, the outflow end portion of the prosthetic heart valve has a greater diameter than the inflow end portion of the prosthetic heart valve.

[0202] Example 17. The method of any example disclosed herein, particularly examples 14-16, wherein a minimum diameter of the prosthetic heart valve in the flared implantation configuration is less than the minimum diameter of the normal working range.

[0203] Example 18. A method of implanting a prosthetic heart valve, the method comprising: identifying one or more characteristics of a target implantation site within a subject that are indicative of an implantation diameter that is greater than a maximum diameter of a normal working range of the prosthetic heart valve when implanted in a parallel implantation configuration, wherein in the parallel implantation configuration a diameter of an inflow end portion of the prosthetic heart valve is equal to a diameter of an outflow end portion of the prosthetic heart valve; selecting a delivery apparatus that includes a tapered balloon coupled to a distal end portion of a shaft of the delivery apparatus; advancing the distal end portion of the shaft having the prosthetic heart valve radially compressed around the tapered balloon through vasculature of the subject to the target implant site; and inflating the tapered balloon to radially expand the prosthetic heart valve to a tapered implantation configuration.

[0204] Example 19. The method of any example disclosed herein, particularly example 18, wherein the tapered balloon comprises an intermediate working portion, and wherein, when inflated, a diameter of a distal end of the intermediate working portion is greater than a diameter of a proximal end of the intermediate working portion.

[0205] Example 20. The method of any example disclosed herein, particularly examples 18 or 9, wherein, in the tapered implantation configuration, the inflow end portion of the prosthetic heart valve has a greater diameter than the outflow end portion of the prosthetic heart valve.

[0206] Example 21. The method of any example disclosed herein, particularly examples 18-20, wherein a maximum diameter of the prosthetic heart valve in the tapered implantation configuration is greater than the maximum diameter of the normal working range.

[0207] Example 22. An assembly comprising: a prosthetic heart valve comprising an annular frame and a valve structure disposed within an interior space of the frame and having an inflow end portion and an outflow end portion, the valve structure comprising a plurality of leaflets, each of the leaflets joined to an adjacent leaflet at the outflow end portion of the valve structure to form a commissure therebetween, each of the commissures attached to the frame; and a delivery apparatus comprising a shaft and a tapered balloon coupled to a distal end portion of the shaft, wherein the tapered balloon comprises an intermediate portion configured to receive the prosthetic heart valve radially compressed therearound, wherein theintermediate portion has a proximal end and a distal end; wherein, in an inflated state of the tapered balloon, the distal end of the intermediate portion has greater diameter than its proximal end, and a first section of the intermediate portion extending from the proximal end in a proximal to distal direction comprises an angled wall that angles away from a central axis of the tapered balloon and intersects with a second section of the intermediate portion that comprises a parallel wall that is parallel to the central axis of the tapered balloon, wherein the angled wall intersects with the parallel wall at an intersection.

[0208] Example 23. The assembly of any example disclosed herein, particularly example 22, wherein, in the inflated state of the tapered balloon, the proximal end of the intermediate portion is spaced in an axial direction from the intersection between the angled wall and the parallel wall by a first distance, wherein the first distance is greater than or equal to a height of the commissures.

[0209] Example 24. The assembly of any example disclosed herein, particularly examples 22 or 23, wherein, in the inflated state of the tapered balloon, the proximal end of the intermediate portion is spaced in a radial direction from the intersection between the angled wall and the parallel wall by a second distance, wherein the second distance is greater than or equal to a thickness of the commissures.

[0210] Example 25. The assembly of any example disclosed herein, particularly examples 22-24, wherein the delivery apparatus comprises a first delivery apparatus and the assembly further comprises a second delivery apparatus comprising a shaft and a flared balloon coupled to a distal end portion of the shaft of the second delivery apparatus, wherein the flared balloon comprises an intermediate portion configured to receive the prosthetic heart valve radially compressed therearound, wherein the intermediate portion of the flared balloon has a proximal end and a distal end; wherein, in an inflated state of the flared balloon, the flared balloon has an inverted shape relative to the tapered balloon in the inflated state.

[0211] Example 26. The assembly of any example disclosed herein, particularly examples 22-24, wherein the delivery apparatus comprises a first delivery apparatus and the assembly further comprises a second delivery apparatus comprising a shaft and a parallel balloon coupled to a distal end portion of the shaft of the second delivery apparatus, wherein the parallel balloon comprises an intermediate portion configured to receive the prosthetic heart valve radially compressed therearound, wherein the intermediate portion has a proximal end and a distal end; wherein, in an inflated state of the parallel balloon, the distal end of the intermediate portion has same diameter as the proximal end.

[0212] Example 27. A method of implanting a prosthetic heart valve, the method comprising: identifying one or more characteristics of a target implantation site within a subject that are indicative of an implantation diameter that is lower than a minimum diameter of a normal working range of the prosthetic heart valve when implanted in a parallel implantation configuration, wherein in the parallel implantation configuration a diameter of an inflow end portion of the prosthetic heart valve is equal to a diameter of an outflow end portion of the prosthetic heart valve: advancing a distal end portion of a shaft of a delivery apparatus and the prosthetic heart valve through vasculature of the subject to the target implant site, wherein the prosthetic heart valve is in a radially compressed state; and radially expanding the prosthetic heart valve to a flared implantation configuration wherein the diameter of the inflow end portion of the prosthetic heart valve is less than the diameter of the outflow end portion of the prosthetic heart valve.

[0213] Example 28. A method of implanting a prosthetic heart valve, the method comprising: identifying one or more characteristics of a target implantation site within a subject that are indicative of an implantation diameter that is greater than a maximum diameter of a normal working range of the prosthetic heart valve when implanted in a parallel implantation configuration, wherein in the parallel implantation configuration a diameter of an inflow end portion of the prosthetic heart valve is equal to a diameter of an outflow end portion of the prosthetic heart valve; advancing a distal end portion of a shaft of a delivery apparatus and the prosthetic heart valve through vasculature of the subject to the target implant site, wherein the prosthetic heart valve is in a radially compressed state; and radially expanding the prosthetic heart valve to a tapered implantation configuration wherein the diameter of the inflow end portion of the prosthetic heart valve is greater than the diameter of the outflow end portion of the prosthetic heart valve.

[0214] Example 29. An assembly comprising: a first delivery apparatus comprising a shaft and a first balloon, wherein the first balloon is a parallel balloon coupled to a distal end portion of the shaft of the first delivery apparatus, wherein the parallel balloon comprises an intermediate portion configured to receive the prosthetic heart valve radially compressed therearound, wherein the intermediate portion of the parallel balloon has a proximal end and a distal end, and wherein, in an inflated state of the parallel balloon, the distal end of the intermediate portion has same diameter as the proximal end; and a second delivery apparatus comprising a shaft and a second balloon, wherein the second balloon is one of a tapered balloon or a flared balloon coupled to a distal end portion of the shaft of the second delivery apparatus.

[0215] Example 30. The assembly of any example disclosed herein, particularly example 29, wherein the second balloon is the tapered balloon, wherein the tapered balloon comprises an intermediate portion configured to receive a prosthetic heart valve radially compressed therearound, wherein the intermediate portion of the tapered balloon has a proximal end and a distal end, and wherein, in an inflated state of the tapered balloon, the proximal end has a smaller diameter than the distal end.

[0216] Example 31. The assembly of any example disclosed herein, particularly example 29, wherein the second balloon is the flared balloon, wherein the flared balloon comprises an intermediate portion configured to receive a prosthetic heart valve radially compressed therearound, wherein the intermediate portion of the flared balloon has a proximal end and a distal end, and wherein, in an inflated state of the flared balloon, the proximal end has a greater diameter than the distal end.

[0217] Example 32. A delivery apparatus comprising: a shaft; and a balloon coupled to a distal end portion of the shaft, wherein the balloon comprises an intermediate portion configured to receive a prosthetic heart valve radially compressed therearound, wherein the intermediate portion has a proximal end and a distal end; wherein, in an inflated state of the balloon, the intermediate portion comprises a cylindrical portion and an angled portion, wherein a wall of the balloon in the cylindrical portion is parallel to a longitudinal axis of the balloon, wherein a wall of the balloon in the angled portion is angled relative to the longitudinal axis of the balloon, and wherein an intersection between the wall of the balloon in the cylindrical portion and the wall of the balloon in the angled portion forms an angle on an exterior surface of the balloon in a range of 181° to 270°.

[0218] Example 33. The delivery apparatus of any example disclosed herein, particularly example 32, wherein the balloon is a flared balloon, wherein the angled portion extends between the distal end of the intermediate portion and the cylindrical portion, and wherein the wall in the angled portion angles away from a central axis of the balloon in a distal to proximal direction.

[0219] Example 34. The delivery apparatus of any example disclosed herein, particularly example 32, wherein the balloon is a tapered balloon, wherein the angled portion extends between the proximal end and the intermediate portion, and wherein the wall in the angled portion angles toward a central axis of the balloon in a distal to proximal direction.

[0220] Example 35. The delivery apparatus of any example disclosed herein, particularly example 32, wherein the balloon comprises a proximal conical portion connected to and extending proximally from the proximal end of the intermediate portion and a distal conicalportion connected to and extending proximally from the distal end of the intermediate portion.

[0221] Example 36. The delivery apparatus of any example disclosed herein, particularly example 35, wherein the proximal conical portion intersects the proximal end of the intermediate portion at an angle that is greater than the angle defined by the cylindrical portion and the angled portion of the intermediate portion.

[0222] Example 37. The delivery apparatus of any example disclosed herein, particularly example 35, wherein the distal conical portion intersects the distal end of the intermediate portion at an angle that is greater than the angle defined by the cylindrical portion and the angled portion of the intermediate portion.

[0223] Example 38. The delivery apparatus of any example disclosed herein, particularly example 35, in combination with a prosthetic heart valve, wherein the balloon is in an uninflated state and the prosthetic heart valve is in a radially compressed state on the uninflated balloon with commissures of the prosthetic heart valve disposed over the angled portion of the intermediate portion of the balloon.

[0224] Example 39. A method of any one of the examples disclosed herein comprising sterilizing the prosthetic heart valve, apparatus, and / or assembly of any example.

[0225] Example 40. A delivery apparatus or assembly of any one of the examples disclosed herein, particularly examples 22-26 or 29-38, wherein the prosthetic heart valve, apparatus, and / or assembly is sterilized.

[0226] Example 41. A method of any one of the examples disclosed herein, particularly examples 1-21 and 27-28, comprising treating a heart on a simulation.

[0227]

[0228] Example 42. A method comprising: determining one or more characteristics of a target implantation site; based at least in part on the one or more characteristics of the target implantation site, determining one or more of a target implantation diameter or a target implantation configuration for a prosthetic heart valve; based at least in part on the one or more of the target implantation diameter or the targeted implantation configuration, selecting a delivery apparatus from a set of delivery apparatuses each having a balloon with a different shape; advancing a distal end portion of the selected delivery apparatus to the target implantation site; and inflating the balloon of the selected delivery apparatus to radially expand the prosthetic heart valve.

[0229] Example 43. The method of example 42, wherein the target implantation site comprises at least one of a native valve and a prosthetic valve.

[0230] Example 44. A method of example 42 or 43, further comprising any of the steps of examples 1-21 and 27-28.

[0231] Example 45. A method comprising: determining a target implantation configuration for a prosthetic heart valve; based at least on the target implantation configuration, selecting a delivery apparatus from a set of delivery apparatuses, the set of delivery apparatus including at least a first delivery apparatus and a second delivery apparatus having different balloon shapes, wherein each balloon shape of the different balloon shapes is selected from parallel, flared, and tapered; and inflating the balloon of the selected delivery apparatus to radially expand the prosthetic heart valve to the target implantation configuration.

[0232] Example 46. A method of example 45, further comprising any of the steps of examples 1-21 and 27-28.

[0233] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one balloon can be combined with any one or more features of another balloon. As another example, any one or more features of one delivery apparatus can be combined with any one or more features of another delivery apparatus.

[0234] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

We claim:

1. A method comprising: determining one or more characteristics of a target implantation site; based on the one or more characteristics of the target implantation site, determining one or more of a target implantation diameter or a target implantation configuration for a prosthetic heart valve; based at least on the one or more of the target implantation diameter or the targeted implantation configuration, selecting a delivery apparatus from a set of delivery apparatuses each having a balloon with a different shape; advancing a distal end portion of the selected delivery apparatus to a native heart valve; and inflating the balloon of the selected delivery apparatus to radially expand the prosthetic heart valve to the one or more of the targeted implantation diameter or the target implantation configuration at the target implantation site.

2. The method of claim 1, wherein the determining one or more characteristics of the target implantation site comprises determining at least one of a diameter of a native annulus or a diameter of a previously implanted prosthetic valve within which the prosthetic heart valve will be implanted.

3. The method of claim 2, wherein the determining the one or more of the target implantation diameter or the target implantation configuration for the prosthetic heart valve comprises determining the at least one of the diameter of the native annulus or the diameter of the previously implanted prosthetic valve is indicative of a size that will result in the prosthetic heart valve being deployed to a target diameter that is within a normal working range of the prosthetic heart valve; and wherein the selected delivery apparatus has a parallel balloon, wherein the parallel balloon comprises an intermediate working portion, wherein, when inflated, a diameter of a proximal end of the intermediate working portion is equal to a diameter of a distal end of the intermediate working portion.

4. The method of claim 2, wherein the determining the one or more of the target implantation diameter or the target implantation configuration for the prosthetic heart valvecomprises determining the at least one of the diameter of the native annulus or the diameter of the previously implanted prosthetic valve is indicative of a size that will result in the prosthetic heart valve being deployed to a diameter that is below a normal working range of the prosthetic heart valve; and wherein the selected delivery apparatus has a flared balloon, wherein the flared balloon comprises an intermediate working portion, wherein, when inflated, a diameter of a proximal end of the intermediate working portion is greater than a diameter of a distal end of the intermediate working portion.

5. The method of claim 2, wherein the determining the one or more of the target implantation diameter or the target implantation configuration for the prosthetic heart valve comprises determining the at least one of the diameter of the native annulus or the diameter of the previously implanted prosthetic valve is indicative of a size that will result in the prosthetic heart valve being deployed to a diameter that is above a normal working range of the prosthetic heart valve; and wherein the selected delivery apparatus has a tapered balloon, wherein the tapered balloon comprises an intermediate working portion, wherein, when inflated, a diameter of a proximal end of the intermediate working portion is less than a diameter of a distal end of the intermediate working portion.

6. The method of claim 1, wherein the prosthetic heart valve is implanted in a native annulus, and wherein the determining one or more characteristics of the target implantation site comprises determining a deficiency in one or more of a diameter of an inflow end portion of the prosthetic heart valve relative to a current diameter thereof or a diameter of an outflow end portion of the prosthetic heart valve relative to a current diameter thereof.

7. The method of claim 6, wherein the determining the one or more of the target implantation diameter or the target implantation configuration for the prosthetic heart valve comprises determining a desired increase in each of the diameter of the outflow end portion and the diameter of the inflow end portion of the prosthetic heart valve; and wherein the selected delivery apparatus has a parallel balloon, wherein the parallel balloon comprises an intermediate working portion, and wherein, when inflated, a diameterof a proximal end of the intermediate working portion is equal to a diameter of a distal end of the intermediate working portion.

8. The method of claim 6, wherein the determining the one or more of the target implantation diameter or the target implantation configuration for the prosthetic heart valve comprises determining a desired increase in only the diameter of the outflow end portion of the prosthetic heart valve; and wherein the selected delivery apparatus has a flared balloon, wherein the flared balloon comprises an intermediate working portion, and wherein, when inflated, a diameter of a proximal end of the intermediate working portion is greater than a diameter of a distal end of the intermediate working portion.

9. The method of claim 6, wherein the determining the one or more of the target implantation diameter or the target implantation configuration for the prosthetic heart valve comprises determining a desired increase in only the diameter of the inflow end portion of the prosthetic heart valve; and wherein the selected delivery apparatus has a tapered balloon, and wherein the tapered balloon comprises an intermediate working portion, wherein, when inflated, a diameter of a proximal end of the intermediate working portion is less than a diameter of a distal end of the intermediate working portion.

10. A method comprising: determining a target implantation configuration for a prosthetic heart valve; based at least on the target implantation configuration, selecting a delivery apparatus from a set of delivery apparatuses, the set of delivery apparatus including a first delivery apparatus with a parallel balloon, a second delivery apparatus with a flared balloon, and a third delivery apparatus with a tapered balloon; and inflating the balloon of the selected delivery apparatus to radially expand the prosthetic heart valve to the target implantation configuration.

11. The method of claim 10, wherein the target implantation configuration is a parallel implantation configuration in which an outflow end portion of the prosthetic heart valve has a diameter that is equal to an inflow end portion of the prosthetic heart valve, and the selected delivery apparatus is the first delivery apparatus.

12. The method of claim 10, wherein the target implantation configuration is a flared implantation configuration in which an outflow end portion of the prosthetic heart valve has a greater diameter than an inflow end portion of the prosthetic heart valve, and the selected delivery apparatus is the second delivery apparatus.

13. The method of claim 10, wherein the target implantation configuration is a tapered implantation configuration in which an inflow end portion of the prosthetic heart valve has a greater diameter than an outflow end portion of the prosthetic heart valve, and the selected delivery apparatus is the third delivery apparatus.

14. An assembly comprising: a prosthetic heart valve comprising an annular frame and a valve structure disposed within an interior space of the frame and having an inflow end portion and an outflow end portion, the valve structure comprising a plurality of leaflets, each of the leaflets joined to an adjacent leaflet at the outflow end portion of the valve structure to form a commissure therebetween, each of the commissures attached to the frame; and a delivery apparatus comprising a shaft and a tapered balloon coupled to a distal end portion of the shaft, wherein the tapered balloon comprises an intermediate portion configured to receive the prosthetic heart valve radially compressed therearound, wherein the intermediate portion has a proximal end and a distal end; wherein, in an inflated state of the tapered balloon, the distal end of the intermediate portion has greater diameter than its proximal end, and a first section of the intermediate portion extending from the proximal end in a proximal to distal direction comprises an angled wall that angles away from a central axis of the tapered balloon and intersects with a second section of the intermediate portion that comprises a parallel wall that is parallel to the central axis of the tapered balloon, wherein the angled wall intersects with the parallel wall at an intersection.

15. The assembly of claim 14, wherein, in the inflated state of the tapered balloon, the proximal end of the intermediate portion is spaced in an axial direction from the intersection between the angled wall and the parallel wall by a first distance, wherein the first distance is greater than or equal to a height of the commissures.

16. The assembly of either claim 14 or claim 15, wherein, in the inflated state of the tapered balloon, the proximal end of the intermediate portion is spaced in a radial direction from the intersection between the angled wall and the parallel wall by a second distance, wherein the second distance is greater than or equal to a thickness of the commissures.

17. The assembly of any of claims 14-16, wherein the delivery apparatus comprises a first delivery apparatus and the assembly further comprises a second delivery apparatus comprising a shaft and a flared balloon coupled to a distal end portion of the shaft of the second delivery apparatus, wherein the flared balloon comprises an intermediate portion configured to receive the prosthetic heart valve radially compressed therearound, wherein the intermediate portion of the flared balloon has a proximal end and a distal end; wherein, in an inflated state of the flared balloon, the flared balloon has an inverted shape relative to the tapered balloon in the inflated state.

18. The assembly of any of claims 14-16, wherein the delivery apparatus comprises a first delivery apparatus and the assembly further comprises a second delivery apparatus comprising a shaft and a parallel balloon coupled to a distal end portion of the shaft of the second delivery apparatus, wherein the parallel balloon comprises an intermediate portion configured to receive the prosthetic heart valve radially compressed therearound, wherein the intermediate portion has a proximal end and a distal end; wherein, in an inflated state of the parallel balloon, the distal end of the intermediate portion has same diameter as the proximal end.

19. A delivery apparatus comprising: a shaft; and a balloon coupled to a distal end portion of the shaft, wherein the balloon comprises an intermediate portion configured to receive a prosthetic heart valve radially compressed therearound, wherein the intermediate portion has a proximal end and a distal end; wherein, in an inflated state of the balloon, the intermediate portion comprises a cylindrical portion and an angled portion, wherein a wall of the balloon in the cylindrical portion is parallel to a longitudinal axis of the balloon, wherein a wall of the balloon in the angled portion is angled relative to the longitudinal axis of the balloon, and wherein an intersection between the wall of the balloon in the cylindrical portion and the wall of theballoon in the angled portion forms an angle on an exterior surface of the balloon in a range of 181° to 270°.

20. The delivery apparatus of claim 19, wherein the balloon comprises a proximal conical portion connected to and extending proximally from the proximal end of the intermediate portion and a distal conical portion connected to and extending proximally from the distal end of the intermediate portion.

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