Prosthetic heart valve delivery system

Abstract

Off-balloon prosthetic valve delivery procedures involving valve positioning structures are disclosed. As one example, a delivery procedure can include crimping a prosthetic valve around a valve positioning structure of a delivery system, wherein the valve positioning structure can be in a first, off-balloon position relative to a balloon of the delivery system, and moving the valve positioning structure in an axial direction to a second, on-balloon position relative to the balloon. The second position can be axially spaced apart from the first position. In the second position, inflating the balloon can be effective to radially expand the valve positioning structure and the prosthetic valve. In this way, the prosthetic valve can be crimped around the valve positioning structure in the off-balloon position to further minimize the crimped profile of the prosthetic valve.

Description

PROSTHETIC HEART VALVE DELIVERY SYSTEMCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 734,826, filed on December 17, 2024, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to delivery systems for prosthetic heart valves, and in particular to delivery systems with inflatable balloons for deploying prosthetic heart valves.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 portion 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 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 selfexpand to its functional size.SUMMARY

[0004] Described herein are prosthetic heart valves, delivery apparatuses, delivery systems, and methods for implanting prosthetic heart valves. The disclosed prosthetic heart valves, delivery apparatuses, delivery systems, and methods can, for example, provide for improved positioning of a prosthetic heart valve on a delivery apparatus, for example, during advancement of the delivery apparatus through a subject’s vasculature, among other things. As such, the devices and methods disclosed herein can, among other things, provide improved balloon expandable delivery systems.

[0005] A delivery system for a prosthetic implant can comprise a handle and a first shaft coupled to the handle.

[0006] In some examples, the delivery system can comprise a balloon coupled to a distal end portion of the first shaft.

[0007] In some examples, the balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state.

[0008] In some examples, the delivery system can include a first valve positioning structure.

[0009] In some examples, the first valve positioning structure can extend at least partially over an exterior surface of the balloon and can have a first end portion and a second end portion.

[0010] In some examples, the first valve positioning structure can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated.

[0011] In some examples, the first valve positioning structure can resiliently radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0012] In some examples, the first valve positioning structure can comprise a frame constructed of a shape -memory material.

[0013] In some examples, the frame can be shape set in the radially collapsed configuration.

[0014] In some examples, the first valve positioning structure can extend around the exterior surface of the balloon at the first end portion.

[0015] In some examples, the first valve positioning structure can extend around the exterior surface of the balloon at both the first end portion and the second end portion of the balloon.

[0016] In some examples, the first valve positioning structure can comprise a proximal valve positioning portion and a distal valve positioning portion.

[0017] In some examples, the first valve positioning structure can include an intermediate valve positioning portion disposed between the proximal and distal valve positioning portions.

[0018] In some examples, the proximal valve positioning portion can be coupled to the shaft.

[0019] In some examples, the delivery system can further comprise a nose cone distally disposed relative to the balloon.

[0020] In some examples, the distal valve positioning portion can be coupled to the nose cone.

[0021] In some examples, the intermediate valve positioning portion can be configured to receive the prosthetic valve.

[0022] In some examples, the distal valve positioning portion can have an outer diameter that is greater than an outer diameter of the intermediate valve positioning portion.

[0023] In some examples, the proximal valve positioning portion can have an outer diameter that is greater than an outer diameter of the intermediate valve positioning portion.

[0024] In some examples, the distal valve positioning portion can comprise a plurality of struts.

[0025] In some examples, the plurality of struts can include a first plurality of stmts arranged in a first row that extends in a circumferential direction of the delivery system.

[0026] In some examples, the plurality of stmts can include a second plurality of stmts arranged in a second row that extends in the circumferential direction.

[0027] In some examples, each one of the first plurality of stmts can be a linear stmt oriented at an angle relative to an axial direction of the delivery system.

[0028] In some examples, each one of the first plurality of stmts can be a linear stmt oriented in an axial direction of the delivery system.

[0029] In some examples, each one of the second plurality of stmts can be a serpentine stmt.

[0030] In some examples, each one of the second plurality of struts can be a zigzag stmt.

[0031] In some examples, the balloon can have an axial length in a range from 45 mm to 51 mm.

[0032] In some examples, the balloon can have an axial length in a range from 31 mm to 45 mm.THVDL-23563 wool

[0033] In some examples, the balloon can have an axial length in a range from 25 mm to 31 mm.

[0034] In some examples, the frame can comprise a braided mesh structure.

[0035] In some examples, the first valve positioning structure can comprise a polymeric coating attached to the frame.

[0036] In some examples, the first valve positioning structure can be connected to a second shaft of the delivery apparatus.

[0037] In some examples, the second shaft can be translated in an axial direction relative to the first shaft.

[0038] In some examples, the first valve positioning structure can be moved between an off- balloon position and an on-balloon position.

[0039] In some examples, the delivery system can further comprise a second valve positioning structure extending over the exterior surface of the balloon.

[0040] In some examples, the first valve positioning structure and the second valve positioning structure can be spaced apart in an axial direction of the delivery system.

[0041] In some examples, the first valve positioning structure and the second valve positioning structure can define a valve mounting portion of the delivery system configured to receive the prosthetic valve.

[0042] In some examples, neither the first valve positioning structure nor the second valve positioning structure can extend over an outer surface of the prosthetic valve when the prosthetic valve is mounted over the valve mounting portion.

[0043] In some examples, the delivery system can further comprise at least one tether connected to the first valve positioning structure.

[0044] In some examples, the at least one tether can be configured to cause the first valve positioning structure to further radially collapse when the first valve positioning structure is in the radially collapsed state and tension is increased in the tether.

[0045] In some examples, the first valve positioning structure can extend an entire length of the balloon.

[0046] In some examples, the first valve positioning structure can be configured such that it does not overlap or extend over any portion of an outer surface of an implant (for example, a prosthetic heart valve) mounted in a radially compressed state on a balloon of the delivery system.

[0047] In some examples, the first valve positioning structure can be configured such that it does not overlap or extend over any portion of an outer surface of an implant (for example, a prosthetic heart valve) mounted in a radially compressed on the first valve positioning structure.

[0048] In some examples the first valve positioning structure can be configured such that when an implant (for example, a prosthetic heart valve) is mounted in a radially compressed state on the first valve positioning structure, no portion of the implant contacts the balloon of the delivery system.

[0049] In some examples, a delivery apparatus comprises: a handle, a shaft, a balloon, and a valve positioning structure. The shaft can be coupled to the handle. The balloon can be coupled to a distal end portion of the shaft. The balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state. The balloon can include a valve mounting portion for mounting the prosthetic valve in a radially compressed state. The valve positioning structure can extend at least partially over an exterior surface of the balloon and can have a first end portion and a second end portion. The valve positioning structure can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then resiliently radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0050] In some examples, a delivery system for delivering a prosthetic valve through vasculature of a subject (e.g., a living subject, a simulation, etc.) can comprise: a radially expandable prosthetic valve and a delivery apparatus. The delivery apparatus can comprise: a handle, a shaft, an expandable distal valve positioning structure, and a an expandable proximal valve positioning structure. The shaft can be coupled to the handle and a balloon coupled to a distal end portion of the shaft. The balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state. The prosthetic valve can be mounted on the balloon in a radially compressed state. The expandable distal valve positioning structure can be disposed on an exterior surface of a distal end portion of the balloon. The expandable proximal valve positioning structure can be disposed on an exterior surface of a proximal end portion of the balloon. The distal and proximal valve positioning structures can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0051] In some examples, a delivery system for delivering a prosthetic valve through vasculature of a subject can comprise: a radially expandable prosthetic valve and a delivery apparatus. The delivery apparatus can comprise: a handle, a shaft, and an expandable valve positioning structure. The shaft can be coupled to the handle and a balloon coupled to a distal end portion of the shaft. The balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state. The prosthetic valve can be mounted on the balloon in a radially compressed state. The expandable valve positioning structure can be disposed on an exterior surface of a portion of the balloon. The valve positioning structure can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then resiliently radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0052] In some examples, a delivery apparatus for delivering a prosthetic valve through vasculature of a subject can comprise: a handle, a balloon catheter, and a first valve positioning structure. The balloon catheter can comprise a shaft coupled to the handle and a balloon connected to a distal end portion of the shaft. The balloon can be configured to be inflated from an uninflated state to an inflated state. The first valve positioning structure can extend over an exterior surface of the balloon. The first valve positioning structure can comprise a first frame constructed of a shape -memory material. The first frame can be shape set in a radially compressed configuration.

[0053] In some examples, a delivery apparatus for delivering a prosthetic valve through vasculature of a subject can comprise: a handle, a shaft, a balloon, and a valve positioning system. The shaft can be coupled to the handle. The balloon can be coupled to a distal end portion of the shaft. The balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state. The balloon can have a proximal end portion, a distal end portion, and a valve mounting portion disposed between the proximal and distal end portions for mounting the prosthetic valve in a radially compressed state. The valve positioning structure can comprise a frame, wherein the valve positioning structure can be positioned radially outward of the balloon, the valve positioning structure can extend over the proximal end portion of the balloon, the valve mounting portion of the balloon, and the distal end portion of the balloon, and the valve positioning structure can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon isinflated and then radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0054] In some examples, a delivery apparatus for a prosthetic medical device can comprise a handle, a shaft, a balloon, and a valve positioning system. The shaft can be coupled to the handle. The balloon can be coupled to a distal end portion of the shaft. The valve positioning structure can extend at least partially over an outer surface of the balloon, wherein the valve positioning structure can comprise a frame constructed of a shape-memory material.

[0055] In some examples, a delivery apparatus for a prosthetic medical device can comprise: a handle, a shaft, a balloon, and a valve positioning structure. The shaft can be coupled to the handle. The balloon can be coupled to a distal end portion of the shaft and can comprise an outer surface. The valve positioning structure can extend at least partially over the outer surface of the balloon and can comprise a frame that includes a plurality of stmts. The frame can define an axial direction and a circumferential direction.

[0056] In some examples, a delivery system can comprise: a balloon, an expandable distal valve positioning structure, an expandable proximal valve positioning structure, and a prosthetic heart valve. The balloon can comprise: an outer surface extending from a distal end to a proximal end of the balloon and a valve mounting portion disposed on the outer surface between the distal and proximal ends. The expandable distal valve positioning structure can extend over a distal portion of the outer surface of the balloon. The expandable proximal valve positioning structure can extend over a proximal portion of the outer surface of the balloon. The prosthetic heart valve can be crimped around the valve mounting portion of the balloon, wherein neither the distal valve positioning structure nor the proximal valve positioning structure can overlap an outer surface of the prosthetic heart valve.

[0057] In some examples, a method can include crimping a prosthetic valve around a valve positioning structure of a delivery system, wherein the valve positioning structure can be in a first position relative to a balloon of the delivery system, and moving the valve positioning structure in an axial direction to a second position relative to the balloon. The second position can be axially spaced apart from the first position. In the second position, inflating the balloon can be effective to radially expand the valve positioning structure and the prosthetic valve.

[0058] In some examples, a method can include crimping a prosthetic valve around an intermediate portion of a valve positioning structure, wherein the intermediate portion of the valve positioning structure can be spaced apart in an axial direction from a valve mounting portion of a balloon, aligning, within a descending aorta of a subject, the intermediate portion of the valve positioning structure in the axial direction with the valve mounting portion of the balloon, and aligning a commissure of the prosthetic valve that can be crimped around the intermediate portion of the valve mounting structure with a native aortic valve commissure of the subject.

[0059] In some examples, a delivery system can include a first shaft, a balloon coupled to a distal end portion of the first shaft, a second shaft, and a valve positioning structure coupled to a distal end portion of the second shaft. The second shaft and the valve positioning structure can be movable in an axial direction relative to the first shaft and the balloon.

[0060] In some examples, a delivery apparatus can include one or more of the components recited in Examples 151-179 below.

[0061] 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).

[0062] 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

[0063] FIG. 1 is a side view of a prosthetic heart valve, according to one example.

[0064] FIG. 2A is a side view of a delivery apparatus for a prosthetic heart valve, according to one example.

[0065] FIG. 2B is a side view of a distal end portion of a delivery apparatus for a prosthetic heart valve, according to another example.

[0066] FIG. 3 is a side view of a distal end portion of the delivery apparatus of FIG. 2A having valve positioning structures, according to one example, shown with a balloon in an uninflated state.

[0067] FIG. 4A is a perspective view of the distal end portion of the delivery apparatus of FIG. 3, shown with the balloon in an uninflated state and a prosthetic heart valve in a radially crimped state on the balloon.

[0068] FIG. 4B is a perspective view of the distal end portion of the delivery apparatus of FIG. 4A, shown with the balloon in an inflated state and the prosthetic heart valve in a radially expanded state.

[0069] FIG. 5A is a side view of a distal valve positioning structure comprising a frame, according to one example.

[0070] FIG. 5B is a side view of a proximal valve positioning structure comprising a frame, according to one example.

[0071] FIG. 5C is a flattened view of a frame of the valve positioning structures of FIGS. 5A- 5B, according to one example.

[0072] FIG. 6A is a side view of a distal valve positioning structure, according to one example.

[0073] FIG. 6B is a side view of a proximal valve positioning structure, according to one example.

[0074] FIG. 7A is a side view of a distal end portion of a delivery apparatus having distal and proximal valve positioning structures, according to one example, shown with a balloon in an uninflated state.

[0075] FIG. 7B is a side view of a suture connected to a proximal end portion of the distal valve positioning structure of FIG. 7A, according to one example.

[0076] FIG. 7C is a side view of a suture connected to a proximal end portion of a valve positioning structure, according to one example.

[0077] FIG. 8A is a side view of a distal end portion of a portion delivery apparatus having a valve positioning structure, according to one example, shown with a balloon in an uninflated state.

[0078] FIG. 8B is a side view of the valve positioning structure of FIG. 8 A, according to one example.

[0079] FIG. 9A is a side view of a distal end portion of a delivery apparatus having a valve positioning structure, according to one example, shown with a balloon in an uninflated state.

[0080] FIG. 9B is a side view of the distal end portion of the delivery apparatus of FIG. 9A, shown with the balloon in a partially radially expanded state.

[0081] FIG. 9C is a side view of the distal end portion of the delivery apparatus of FIGS. 9A- 9B, shown with the balloon in a radially expanded state.

[0082] FIG. 10A is a side view of a valve positioning structure, according to one example.

[0083] FIG. 10B is a flattened view of a frame of the valve positioning structure of FIG. 10 A.

[0084] FIG. 10C is a side view of a distal end portion of a delivery apparatus having the valve positioning structure of FIG. 10A, shown with a balloon in an uninflated state.

[0085] FIG. 10D is a side view of the distal end portion of the delivery apparatus of FIG. 10C, shown with a prosthetic valve crimped around the valve positioning structure and with the balloon in the uninflated state.

[0086] FIG. 10E is a side view of the distal end portion of the delivery apparatus of FIGS. 10C-10D, shown with the balloon a radially expanded state.

[0087] FIG. 11 is a side view of a distal end portion of a delivery apparatus, according to one example, shown with a balloon in an inflated state.

[0088] FIG. 12 is a schematic profile view of balloons for a delivery apparatus, according to one example.

[0089] FIG. 13 is a flattened view of a frame of a valve positioning structure, according to one example.

[0090] FIG. 14A is a side view of a valve positioning structure, according to one example.

[0091] FIG. 14B is a flattened view of a frame of the valve positioning structure of FIG. 14A, according to one example.

[0092] FIG. 15 is a flattened view of a frame of a valve positioning structure, according to one example.

[0093] FIG. 16 is a flattened view of a frame of a valve positioning structure, according to one example.

[0094] FIG. 17 is a flattened view of a frame of a valve positioning structure, according to one example.

[0095] FIG. 18 is a flattened view of a frame of a valve positioning structure, according to one example.

[0096] FIG. 19 is a flattened view of a frame of a valve positioning structure, according to one example.

[0097] FIG. 20A is a side view of a distal end portion of a delivery apparatus, shown with the balloon in an uninflated state, according to one example.

[0098] FIG. 20B is a side view of the distal end portion of the delivery apparatus of FIG.20A, shown with the balloon in an inflated state, according to one example.

[0099] FIG. 20C is a flattened view of a frame of the valve positioning structure of the delivery apparatus of FIGS. 20A-20B, according to one example.

[0100] FIG. 21 is a flattened view of a frame of a valve positioning structure, according to one example.

[0101] FIG. 22 is a flattened view of a frame of a valve positioning structure, according to one example.

[0102] FIG. 23 is a flattened view of a frame of a valve positioning structure, according to one example.

[0103] FIG. 24A is a side view of a distal end portion of a delivery apparatus, shown with the balloon in an uninflated state, according to one example.

[0104] FIG. 24B is a side view of the distal end portion of the delivery apparatus of FIG.24A, shown with the balloon in an inflated state, according to one example.

[0105] FIG. 24C is a flattened view of a frame of the valve positioning structure of the delivery apparatus of FIGS. 24A-24B, according to one example.

[0106] FIG. 25 is a flattened view of a portion of a frame of a valve positioning structure, according to one example.

[0107] FIG. 26 is a flattened view of a frame of a valve positioning structure, according to one example.

[0108] FIG. 27 is a flattened view of a frame of a valve positioning structure, according to one example.

[0109] FIG. 28 is a flattened view of a portion of a frame of a valve positioning structure, according to one example.

[0110] FIG. 29A is a side view of a distal end portion of a delivery apparatus, shown with the balloon in an uninflated state, according to one example.

[0111] FIG. 29B is a side view of the distal end portion of the delivery apparatus of FIG.29 A, shown with the balloon in an inflated state, according to one example.

[0112] FIG. 29C is a flattened view of a portion of the frame of the valve positioning structure of the delivery apparatus of FIGS. 29A-29B, according to one example.

[0113] FIG. 30A is a side view of a distal end portion of a delivery apparatus, according to one example, showing a balloon and a crimp balloon.

[0114] FIG. 30B is a side view of the distal end portion of the delivery apparatus of FIG. 30A during a first stage of a prosthetic valve delivery procedure, wherein the delivery apparatus includes a balloon in a deflated state and a valve positioning structure in an off-balloon position, according to one example.

[0115] FIG. 30C is a side view of the distal end portion of the delivery apparatus of FIG. 30A during a second stage of the prosthetic valve delivery procedure, wherein a prosthetic valve is crimped around the valve positioning structure in the off-balloon position.

[0116] FIG. 30D is a side view of the distal end portion of the delivery apparatus of FIG.30A during a third stage of the prosthetic valve delivery procedure, wherein the valve positioning structure is moved to an on-balloon position.

[0117] FIG. 30E is a side view of the distal end portion of the delivery apparatus of FIG. 30A during a fourth stage of the prosthetic valve delivery procedure, wherein the balloon is expanded to an inflated state, the prosthetic valve is expanded to a radially expanded state, and the valve positioning structure is expanded to a radially expanded state.

[0118] FIG. 31 is a flowchart of an off-balloon delivery procedure, according to an example.DETAILED DESCRIPTIONGeneral Considerations

[0119] 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 disclosedTHVDL-23563 WOOl 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.

[0120] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0121] 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.

[0122] 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 adevice 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.

[0123] 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” or “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.

[0124] 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.

[0125] It will be understood that the benefits and advantages described herein can relate to one implementation or can relate to several implementations. Aspects described in connection with one implementation are intended to be able to be used with the other implementation. Any explanation in connection with one implementation applies to similar features of the other implementations, and elements of multiple implementations can be combined to form other implementations. The implementations are not limited to those that solve any or all of the stated problems or those that have any or all of the stated benefits and advantages.

[0126] The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain implementations herein is intended merely to better illuminate the devices, apparatus, systems, and methods disclosed herein and does not pose a limitation on the scope of the disclosure otherwise claimed. No language in the specification should be constmed as indicating any non-claimed element essential to the practice of the disclosure.

[0127] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of the Disclosed Technology

[0128] Described herein are examples of a delivery apparatus that can be used to navigate a subject’s vasculature to deliver an implantable, expandable medical device (for example, aTHVDL-23563 WOOl prosthetic heart valve), tools, agents, or other therapy to a location within the body of a subject. Examples of procedures in which the steerable catheters are useful include neurological, urological, gynecological, fertility (for example, in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal, and procedures including access in any body duct or cavity. Particular examples include placing implants, including stents, grafts, embolic coils, and the like; positioning imaging devices and / or components thereof, including ultrasound transducers; and positioning energy sources, for example, for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, and the like.

[0129] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a subject’s vasculature on the delivery apparatus. The prosthetic valve can be expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0130] As introduced above, some prosthetic heart valves, such as the example prosthetic heart valve depicted in FIG. 1, can be retained by a delivery apparatus in the radially compressed state and advanced through a subject’s vasculature, such as to a native heart valve, by the delivery apparatus, such as the example delivery apparatus shown in FIG. 2A or FIG. 2B. The prosthetic valve can be expanded to the radially expanded state once the prosthetic valve reaches the implantation site, for example, by expanding a balloon of the delivery apparatus.

[0131] In some examples, the delivery apparatus can include structures that help position the prosthetic heart valve (or any other prosthetic medical device) on the distal end portion of the delivery apparatus. For example, as shown in FIGS. 3-4B, 7A, 8A, 9A-9C, 10C-11, 20A- 20B, 24A-24B, and 29A-29B, an external, expandable valve positioning structure (which is also referred to herein as an external, expandable shoulder) can be coupled to an external surface of the balloon of the delivery apparatus to hold or retain the prosthetic heart valve (or any other prosthetic medical device) in an axially fixed position relative to the deliveryapparatus. In some examples, the structure can be configured with a tapered surface and / or a cross-sectional size that improves the ability of the delivery apparatus to advance the prosthetic heart valve (or any other prosthetic medical device) through an introducer sheath and / or the subject’s vasculature. FIGS. 5A-5B, 6A-6B, 8B, 10A, and 14A show exemplary valve positioning structures in isolation. FIGS. 5C, 10B, 13, and 14B-19, 20C-23, 24C-28, and 29C show flattened views of exemplary frames of valve positioning structures. As a result, the devices and methods disclosed herein can, among other things, improve delivery' apparatuses for prosthetic heart valves (or any other prosthetic medical device) by improving the positioning of the prosthetic heart valve (or any other prosthetic medical device) relative to the delivery apparatus and improving the ability for the delivery apparatus to advance through a subject’s vasculature.Examples of the Disclosed Technology

[0132] FIG. 1 shows a prosthetic heart valve 10 (which is also referred to herein as a “prosthetic valve”), according to one example. Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in some 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.

[0133] 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. Publication No. 2017 / 0231756, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020 / 247907, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implantedwithin the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated by reference herein.

[0134] The prosthetic valve 10 can include a stent or frame 12, a valvular structure 14, an inner skirt 16, and a perivalvular outer sealing member or outer skirt 18. The prosthetic valve 10 can have an inflow end portion 15, an intermediate portion 17, and an outflow end portion 19. The inner skirt 16 can be arranged on and / or coupled to an inner surface of the frame 12 while the outer skirt 18 can be arranged on and / or coupled to an outer surface of the frame 12.

[0135] The valvular structure 14 can comprise three leaflets 40, collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, although in some examples there can be greater or fewer number of leaflets (for example, one or more leaflets 40). The leaflets 40 can be secured to one another at their adjacent sides to form commissures 22 of the leaflet structure 14. The lower edge of valvular structure 14 can have an undulating, curved scalloped shape and can be secured to the inner skirt 16 by sutures (not shown). In some examples, the leaflets 40 can be formed of pericardial tissue (for example, bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated by reference herein.

[0136] The frame 12 can be radially compressible (collapsible) and expandable (for example, expanded configuration shown in FIG. 1) and comprise a plurality of interconnected struts 24. A plurality of apices 26 that are spaced circumferentially apart are formed at the inflow end portion 15 and the outflow end portion 19 of the frame 12 (only the apices 26 at the outflow end portion 19 are visible in FIG. 1). Each apex 26 is formed at a junction between two angled struts 24 at either the inflow end portion 15 or the outflow end portion 19. FIG. 1 depicts a known frame design with apices 26 that form a U-shaped bend between the two angled struts 24. In some examples, an angle 30 between the two angled struts 24, connected at the apex 26, can be in a range of 90 to 120 degrees.

[0137] The frame 12 can be formed with a plurality of circumferentially spaced slots, or commissure windows 20 that are adapted to mount the commissures 22 of the valvular structure 14 to the frame. The frame 12 can be made of any of various suitable plastically- expandable materials (for example, stainless steel, etc.) or self-expanding materials (forexample, Nitinol). When constructed of a plastically -expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially collapsed configuration on a delivery catheter or apparatus and then expanded inside a subject by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic valve can be advanced from the sheath, which allows the prosthetic valve to expand to its functional size.

[0138] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, frame 12, frame 230, etc.) 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 12 can comprise stainless steel. In some examples, the frame 12 can comprise cobalt-chromium. In some examples, the frame 12 can comprise nickel-cobalt- chromium. In some examples, the frame 12 comprises a nickel-cobalt-chromium- molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0139] Any one of the skirts 16 and 18 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the skirts 16 and / or 18 can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the skirts 16 and / or 18 can comprise a fabric without interlaced yams or fibers or randomly interlaced yams or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the skirts 16 and / or 18 can comprise a non-textile or nonfabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such asthermoplastic polyurethane (TPU)), etc. In some examples, the skirts 16 and / or 18 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the skirts 16 and / or 18 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0140] Additional details regarding the prosthetic valve 10 and its various components are described in WIPO Patent Application Publication No. WO 2018 / 222799, which is incorporated by reference herein.

[0141] FIG. 2 A shows a delivery apparatus 100, according to an example, that can be used to implant an expandable prosthetic valve (for example, prosthetic valve 10 of FIG. 1 or any of the other prosthetic medical device described herein). In some examples, the delivery apparatus 100 is usable and / or specifically adapted for use in introducing a prosthetic valve into a heart. Although the specific examples of delivery apparatuses are disclosed herein as usable and / or configured for use with prosthetic heart valves (for example, the prosthetic heart valve 10 of FIG. 1 or any other prosthetic heart valve disclosed herein), the exemplary delivery apparatus can additionally or alternatively be usable and / or configured for use with any other prosthetic medical device (for example, a stent, a graft, an stents, an embolic coil, and / or any other implant).

[0142] The delivery apparatus 100 in the illustrated example of FIG. 2 A is a balloon catheter comprising a handle 102 and a steerable, outer shaft 104 extending distally from the handle 102. The delivery apparatus 100 can further comprise an intermediate shaft 106 (which also may be referred to as a balloon shaft) that extends proximally from the handle 102 and distally from the handle 102, the portion extending distally from the handle 102 also extending coaxially through the outer shaft 104. Additionally, the delivery apparatus 100 can further comprise an inner shaft 108 extending distally from the handle 102 coaxially through the intermediate shaft 106 and the outer shaft 104 and proximally from the handle 102 coaxially through the intermediate shaft 106.

[0143] The outer shaft 104 and the intermediate shaft 106 can be configured to translate (for example, move) longitudinally, along a central longitudinal axis 120 of the delivery apparatus 100, relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a subject’s body.

[0144] 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 114can be mounted on the proximal end portion 110 and can be configured to rotate the intermediate shaft 106 around the central longitudinal axis 120 and relative to the outer shaft 104.

[0145] The adaptor 112 can include a first port 138 configured to receive a guidewire therethrough and a second port 140 configured to receive fluid (for example, inflation fluid) from a fluid source. The second port 140 can be fluidly coupled to an inner lumen of the intermediate shaft 106.

[0146] The intermediate shaft 106 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 104 when a distal end of the outer shaft 104 is positioned away from an inflatable balloon 118 of the delivery apparatus 100. A distal end portion of the inner shaft 108 can extend distally beyond the distal end portion of the intermediate shaft 106.

[0147] The balloon 118 can extend over the inner shaft 108. The balloon 118 can include a distal end portion 118a, an intermediate portion 118b, and a proximal portion 118c.

[0148] In some examples, the distal end portion 118a of the balloon 118 can be coupled to a distal end portion of the delivery apparatus 100, such as to a nose cone 122 (as shown in FIG. 2A), or to an alternate component at the distal end portion of the delivery apparatus 100 (for example, a distal shoulder). The proximal end portion 118c of the balloon 118 can be coupled to a distal end portion of the intermediate shaft 106. The intermediate portion 118b of the balloon 118 and the inner shaft 108 can form or define a valve mounting portion 124 of a distal end portion of the delivery apparatus 100. The distal end portion 118a of the balloon 118 can overlay a distal shoulder 126 of the delivery apparatus 100. The valve mounting portion 124 and the intermediate portion of the balloon 118 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG. 2A, a prosthetic valve (for example, prosthetic valve 150) can be mounted around the balloon 118 at the valve mounting portion 124 of the delivery apparatus 100. The intermediate portion 118b of the balloon is may sometimes be referred to herein as a valve mounting portion of the balloon 118.

[0149] The balloon shoulder assembly, including the distal shoulder 126, is configured to maintain the prosthetic heart valve 150 (or other medical device) at a fixed position on the balloon 118 during delivery through the subject’s vasculature.

[0150] The outer shaft 104 can include a distal tip portion 128 mounted on its distal end. The outer shaft 104 and the intermediate shaft 106 can be translated axially relative to one another to position the distal tip portion 128 adjacent a proximal side of the valve mounting portion 124, when the prosthetic valve 150 is mounted in the radially compressed state on the valve mounting portion 124 (as shown in FIG. 2A) and during delivery of the prosthetic valve 150 to the target implantation site. As such, the distal tip portion 128 can be configured to resist movement of the prosthetic valve 150 relative to the balloon 118 proximally, in the axial direction, when the distal tip portion 128 is arranged adjacent a proximal side of the valve mounting portion 124.

[0151] An annular space can be defined between an outer surface of the inner shaft 108 and an inner surface of the intermediate shaft 106 and can be configured to receive fluid from a fluid source via the second port 140 of the adaptor 112. The annular space can be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 108 and an inner surface of the balloon 118. As such, fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the balloon 118 (for example, from a first, deflated state to a second, radially expanded, inflated state) and radially expand and deploy the prosthetic valve 150.

[0152] An inner lumen of the intermediate shaft 106 can be configured to receive a guidewire therethrough, for navigating the distal end portion of the delivery apparatus 100 to the target implantation site.

[0153] The handle 102 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 100. In the illustrated example, for example, the handle 102 includes an adjustment member, such as the illustrated rotatable knob 160, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 102 through the outer shaft 104 and has a distal end portion affixed to the outer shaft 104 at or near the distal end of the outer shaft 104. Rotating the knob 160 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 100. Further details on steering or flex mechanisms for the delivery apparatus 100 can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein.

[0154] The handle 102 can further include an adjustment mechanism 161 including an adjustment member, such as the illustrated rotatable knob 162, and an associated lockingmechanism including another adjustment member, configured as a rotatable knob 178. The adjustment mechanism 161 is configured to adjust the axial position of the intermediate shaft 106 relative to the outer shaft 104 (for example, for fine positioning at the implantation site). Further details on the delivery apparatus 100 can be found in WIPO Publication No. WO2022 / 046585, which are incorporated by reference herein.

[0155] FIG. 2A shows an example of the delivery apparatus 100 being used for “on-balloon” delivery. For such on-balloon delivery, the prosthetic valve 150 is radially compressed (or “crimped”) directly onto the valve mounting portion 124 of the delivery apparatus 100 (for example, around the intermediate portion 118b of the balloon 118) prior to insertion of the prosthetic valve 150 and the delivery apparatus 100 into a subject’s vasculature.

[0156] FIG. 2B shows an example of the delivery apparatus 100 being used for “off-balloon” delivery. For such off-balloon delivery, the prosthetic valve 150 is radially crimped offset from the valve mounting portion 124 (which is also referred to herein as an “offset position”), such as on the intermediate shaft 106 and / or on a proximal end portion of the balloon 118. The delivery apparatus 100 and the prosthetic valve 150 are inserted through an introducer sheath and into the subject’s vasculature with the prosthetic valve 150 in this offset position. Once inside the subject’s vasculature (for example, within the descending aorta), the prosthetic valve 150 can be moved from the offset position to the valve mounting portion 124 of the balloon 118. This can be accomplished by moving the intermediate shaft 106 proximally relative to the outer shaft 104 or moving the outer shaft 104 distally relative to the intermediate shaft 106 while applying a distally-directed force against a proximal end 150p of the prosthetic valve 150 with a distal end of the distal tip portion 128. In some examples, the adjustment mechanism 161 can be used to move the intermediate shaft 106 relative to the outer shaft 104 for repositioning the prosthetic valve 150. Thereafter, the delivery apparatus 100 can be further advanced to the target implantation site (for example, the native aortic annulus) and the prosthetic valve 150 can be deployed. The delivery apparatus 100 optionally can include a valve mounting member 168 positioned inside the balloon 118 along the valve mounting portion 124 to help maintain the position of the prosthetic valve 150 on the balloon 118.

[0157] FIG. 2B also shows a pull wire 166 (which can extend through a lumen of the shaft 104) having a distal end 166d that is fixed relative to a steerable section 164 of the outer shaft 104. The proximal end of the pull wire 166 can be operatively connected to the adjustmentknob 160 (FIG. 2B) for adjusting the tension in the pull wire 166 for controlling the curvature of the steerable section 164 of the outer shaft 104. Further details regarding a delivery apparatus used for off-balloon delivery of a prosthetic valve are disclosed in U.S. Publication No. U.S. Publication No. 2013 / 0030519, which is incorporated by reference herein.

[0158] When the prosthetic valve 150 is retained on the valve mounting portion 124, a distal end of the prosthetic valve 150 is positioned adjacent a distal end of the valve mounting portion 124, that is, adjacent the distal shoulder 126. As such, the distal shoulder 126 can be configured to resist movement of the prosthetic valve 150 relative to the balloon 118 distally, in the axial direction, for example, when the balloon 118 is initially expanded. In some examples, as shown, the distal shoulder 126 is positioned within the balloon 118, such that the balloon 118 expands in the radially outwards direction and away from the distal shoulder 126 as the balloon 118 expands in the radially outwards direction and deploys the prosthetic heart valve 150. The distal shoulder 126 also functions to protect and shield the leading edge (in other words, the distal edge) of the prosthetic valve 150 from contacting native anatomy as the delivery apparatus 100 is advanced through the subject’s vasculature.

[0159] Additionally, during delivery of the prosthetic valve 150, the outer shaft 104 can be positioned relative to the intermediate shaft 106 such that the distal tip portion 128 is positioned adjacent a proximal end of the valve mounting portion 124 and adjacent a proximal end of the prosthetic valve 150. In some examples, the distal end of the tip portion 128 can abut the proximal end of the prosthetic valve 150. As such, in some examples, the distal tip portion 128 is also referred to herein as a “proximal shoulder.” In this position, the outer shaft 104 is disposed around and covers a portion of the balloon 118. The proximal shoulder 128 can be configured to resist movement of the prosthetic valve 150 relative to the balloon 118 proximally, in the axial direction, for example, as the delivery apparatus 100 and prosthetic valve 150 are advanced through the subject’s vasculature and / or an introducer sheath. However, prior to expanding the balloon 118, the outer shaft 104 must be retracted proximally relative to the intermediate shaft 106 to enable the balloon 118 to be fully inflated (for example, without interference with the outer shaft 104). This is due in part to the outer shaft 104 and / or the proximal shoulder 128 not being expandable when the balloon 1 18 is radially expanded. Also, as noted above, for off-balloon delivery, the distal tip portion 128 of the outer shaft 104 can be used to push the prosthetic valve 150 onto the valve mountingportion 124 once the prosthetic valve 150 and the distal end portion of the delivery apparatus 100 are inserted into the subject’s vasculature.

[0160] Structures positioned inside of a balloon, such as the distal shoulder 126, while effective, involve relatively complex manufacturing steps. For example, once the balloon 118 has been formed or shaped, it can be difficult to insert the distal shoulder 126 inside the balloon 118.

[0161] Moreover, when deploying the prosthetic valve 150, the prosthetic valve 150 desirably is positioned to be substantially coaxial with the annulus of the native heart valve so that the prosthetic valve 150 can be evenly expanded and securely anchored within the annulus. In some circumstances, despite the initial position of the prosthetic valve 150 being coaxial with the native annulus, such coaxiality may be disturbed or lost after retracting the outer shaft 104 off the balloon 1 18 just prior to balloon inflation. This can occur if the steerable section 164 of the outer shaft 104 is retained in a curved state via increased tension in the pull wire (for example, pull wire 166) while the outer shaft 104 is retracted. Retracting the outer shaft 104 retracts the steerable section 164 farther away from the balloon 118 and the prosthetic valve 150. Without the structural support of the steerable section 164, the distal end portion of the intermediate shaft 106 and the distal end portion of the inner shaft 108 (where the balloon 118 and the prosthetic valve 150 are mounted) may deflect slightly relative to the steerable section 164. As a result, the prosthetic valve 150 may no longer be coaxial with the native annulus.

[0162] Thus, in some examples, it may be desirable for stmctures that help maintain the axial position of a prosthetic valve (for example, prosthetic valve 10, prosthetic valve 150) relative to a delivery apparatus (for example, delivery apparatus 100) to be disposed around a balloon (for example, balloon 118) of the delivery apparatus to facilitate insertion of the prosthetic valve through a subject’s vasculature and an introducer sheath, improve the positioning of the prosthetic valve relative to the balloon during delivery, and do so without requiring translation of an outer shaft (for example, outer shaft 104) prior to inflating the balloon, among other things. For example, these structures can be configured to expand as the balloon expands, and in some examples, these structures can help maintain the position of the prosthetic valve relative to the delivery apparatus during radial expansion of the prosthetic valve. In some examples, these stmctures can be used in lieu of a distal shoulder (forexample, distal shoulder 126) and / or a proximal shoulder (for example, proximal shoulder 128).

[0163] FIG. 3 illustrates the valve mounting portion 124 of the distal end portion of the delivery apparatus 100, according to another example. The delivery apparatus 100 of FIG. 3 includes an expandable, external distal valve positioning structure 226 (also referred to herein as a “distal shoulder”) and an expandable, external proximal valve positioning structure 228 (also referred to herein as a “proximal shoulder”). The distal valve positioning structure 226 extends at least partially over the distal portion 118a of the balloon 118 and the proximal valve positioning structure 228 extends at least partially over the proximal portion 118c of the balloon 118.

[0164] Although the valve positioning structures 226, 228 are shown to extend over portions of the outer surface of the balloon 118, in some examples, the valve positioning structures 226, 228 are not adhered, fixed, or otherwise attached to the outer surface of the balloon 118. It should be understood that, similarly, any other valve positioning structure herein need not be adhered, fixed, fastened, or otherwise attached to the outer surface of the balloon 118. For example, the valve positioning structures 226, 228 can contact the outer surface of the balloon 118, but the valve positioning structures 226, 228 are not adhered, fixed, fastened, or otherwise attached to the outer surface of the balloon 118, such that the valve positioning structures 226, 228 can freely move relative to the outer surface as the balloon 118 is inflated. In some examples, the valve positioning structures 226, 228 (or other valve positioning structures disclosed herein) can be adhered, fixed, or otherwise attached to the outer surface of the balloon. In the example of FIG. 3, the internal distal shoulder 126 can be excluded. Similarly, it should be understood that any delivery apparatus or delivery system disclosed herein can lack the internal distal shoulder 126.

[0165] In some examples, any one of the valve positioning structures disclosed herein or any portion(s) thereof can comprise a super-elastic and / or shape-memory material and can be shape set in a radially collapsed configuration (which is also referred to herein as a “radially collapsed state,” “radially compressed state,” and / or “radially compressed configuration”), such that the valve positioning structure can expand to a radially expanded configuration (which is also referred to herein as a “radially expanded state”) upon inflation of the balloon 118 and return to the radially collapsed configuration when the balloon is deflated, as furtherdescribed below. For example, any one of the disclosed valve positioning structures can be made of NitinoL

[0166] As shown, the distal valve positioning structure 226 comprises an annular frame 230, which is further described with reference to FIG. 5C. The distal valve positioning structure 226 can be coupled at its distal end to the nose cone 122. In some examples, the distal valve positioning structure 226 can have an outer diameter that is greater than an outer diameter of the prosthetic valve 150 in its radially compressed state, as shown in FIG. 4A. In this way, the outer profile of the distal valve positioning structure 226 enables the delivery apparatus 100 to be more easily advanced through an introducer sheath and / or a subject’s vasculature in a manner that protects against undesirable contact between the leading edge (the distal end) of the prosthetic valve 150 and the subject’s vasculature and between the leading edge of the prosthetic valve 150 and an inner surface of the introducer sheath. In some examples, the greater outer diameter of the distal valve positioning structure 226 relative to the outer diameter of the prosthetic heart valve 150 can help pre-dilate the introducer sheath ahead of the prosthetic valve 150 as the prosthetic valve (mounted on the delivery apparatus) is inserted into the sheath. In some examples, the greater outer diameter of the distal valve positioning structure 226 relative to the outer diameter of the prosthetic heart valve 150 can help further minimize migration of the prosthetic heart valve 150 relative to the balloon 118 (for example, distal migration) during inflation of the balloon. These advantages can also be realized with any of the examples of distal valve positioning structures and distal valve positioning portions disclosed herein that include an outer diameter that is greater than the outer diameter of the radially compressed prosthetic valve.

[0167] Similarly, the proximal valve positioning structure 228 can comprise the frame 230. As shown, the proximal end of the proximal valve positioning structure 228 is coupled to the intermediate shaft 106. The proximal valve positioning structure 228 can be configured to counteract proximally-directed forces applied by the prosthetic valve 150 during delivery of the prosthetic valve 150 (for example, through an introducer sheath and / or a subject’s vasculature), thereby maintaining the positioning of the prosthetic valve 150 on the balloon 118 as it is advanced through an introducer sheath and the subject’s vasculature.

[0168] In some examples, the frame 230 of the proximal valve positioning structure 228 and the frame 230 of the distal valve positioning structure 226 can be the same frame 230 shape set in different configurations. For example, the frame 230 can be shape set in a distalconfiguration to form the distal valve positioning structure 226, and the frame 230 can be shape set in a proximal configuration to form the proximal valve positioning structure 228. In some examples, the distal valve positioning structure 226 and the proximal valve positioning structure 228 can comprise the same frame 230 shape set in the same configuration, such that the proximal valve positioning structure 228 and the distal valve positioning structure 226 are interchangeable.

[0169] The frame 230 (and any other frame disclosed herein) can be a unitary and / or fastener-free structure that can comprise and / or be formed from a single piece of material (for example, Nitinol), such as in the form of a tube. The frame 230 can comprise a plurality of struts arranged to form a plurality of cells. The plurality of struts and cells can be formed by removing portions (for example, via laser cutting) of the single piece of material.

[0170] Referring now to FIG. 4A, the prosthetic valve 150 can be radially compressed around the intermediate portion 118b of the balloon 118 between the distal valve positioning structure 226 and the proximal valve positioning structure 228 for delivery through the subject’s vasculature. As the distal end portion of the delivery apparatus 100 and the compressed prosthetic valve 150 are advanced through an introducer sheath and / or the subject’s vasculature, the distal valve positioning structure 226 and the proximal valve positioning structure 228 resist or prevent axial movement of the prosthetic valve 150 relative to the balloon 118 (for example, distal migration), and thereby maintain the prosthetic valve 150 at its desired location on the balloon 118 until deployment.

[0171] As shown in FIG. 4A, the valve positioning structures 226, 228 are sized such that there can be gaps between the distal end of the prosthetic valve 150 and the adjacent proximal end of the distal valve positioning structure 226 and between the proximal end of the prosthetic valve 150 and the adjacent distal end of the proximal valve positioning structure 228. The presence of these gaps can facilitate radial expansion of the prosthetic valve 150 without interference from the valve positioning structures 226, 228 upon inflation of the balloon 118.

[0172] In some examples, one of or both the valve positioning structures 226, 228 can be sized such that the distal end of the prosthetic valve 150 abuts the adjacent proximal end of the distal valve positioning structure 226 and / or the proximal end of the prosthetic valve 150 abuts the adjacent distal end of the proximal valve positioning structure 228 when the prosthetic valve 150 is radially compressed around the intermediate portion 118b of theballoon 118. Thus, neither the distal valve positioning structure 226 nor the proximal valve positioning structure 228 overlap or extend over an outer surface of the prosthetic valve 150 when the prosthetic valve 150 is crimped onto the balloon 1 18.

[0173] In some examples, at least one of the distal valve positioning structure 226 and the proximal valve positioning structure 228 can at least partially overlap at least part of the prosthetic heart valve 150 or vice versa. For example, at least one or both of the distal valve positioning structure 226 and the proximal valve positioning structure 228 can be shape set such that the prosthetic heart valve 150 can be crimped over at least an adjacent end portion of at least one of the distal valve positioning structure 226 and the proximal valve positioning structure 228 with an intermediate portion of the prosthetic valve between the opposing end portions in contact with the balloon (that is, a distal end portion of the prosthetic valve can overlap an adjacent end portion of the distal valve positioning structure 226 and / or a proximal end portion of the prosthetic valve can overlap an adjacent end portion of the proximal valve positioning structure 228).

[0174] As shown in FIG. 4B, when the balloon 118 is inflated to radially expand the prosthetic valve 150, the valve positioning structures 226, 228 can radially expand under the force of the balloon 118 from their radially collapsed state (FIG. 4A) to a radially expanded state (FIG. 4B). As noted above, the valve positioning structures 226, 228 can be shape set in the radially collapsed state. Thus, when the balloon 118 is deflated after expanding the prosthetic valve 150, the valve positioning structures 226, 228 can revert to the radially collapsed state of FIG. 4A under their own resiliency, which in some examples can beneficially facilitate the retrieval of the delivery apparatus 100 from the subject’s vasculature. As used herein and throughout this disclosure, the term “resiliency” refers to the ability of a structure to deform to a deformed shape or state in response to an external force and elastically return to a default or relaxed shape or state after the external force is removed. It should be understood that any valve positioning structure disclosed herein can revert back to a radially collapsed or compressed state under its own resiliency.

[0175] While both valve positioning structures 226, 228 are present in the example of FIGS. 3-4B, in some examples, one of the valve positioning structures 226, 228 can be omitted. For example, the delivery apparatus 100 can include the distal valve positioning structure 226 but not the proximal valve positioning structure 228. In some examples, the delivery apparatus100 can include the proximal valve positioning structure 228 but not the distal valve positioning structure 226.

[0176] When both valve positioning structures 226, 228 are present, the prosthetic valve 150 can be initially radially compressed on the valve mounting portion 124 of the balloon 118 for performing an on-balloon delivery procedure. When only one valve positioning structure (for example, the distal valve positioning structure 226) is present, the prosthetic valve 150 can be crimped offset the valve mounting portion 124 of the balloon 118 for performing an off- balloon delivery procedure.

[0177] FIG. 5A is a side view of the distal valve positioning structure 226 in the radially collapsed state. FIG. 5B is a side view of the proximal valve positioning structure 228 in the radially collapsed state. Each one of the distal valve positioning structure 226 and the proximal valve positioning structure 228 can comprise the frame 230, which is best illustrated in a flattened configuration in FIG. 5C. In some examples, the frame 230 can be shape set in a first configuration (a “distal configuration”) to form the distal valve positioning structure 226 or shape set in a second configuration (a “proximal configuration”) to form the proximal valve positioning structure 228. In some examples, the frame 230 of the distal valve positioning structure 226 can have the shape shown in FIG. 5B and the frame 230 of the proximal valve positioning structure 228 can have the shape shown in FIG. 5A. In some examples, each of the distal valve positioning structure 226 and the proximal valve positioning structure 228 can comprise the frame 230 shape set in the same configuration, such that the distal valve positioning structure 226 and the proximal valve positioning structure 228 are interchangeable. In some examples, using a standard frame (for example, frame 230) for the distal valve positioning structure 226 and the proximal valve positioning structure 228 can beneficially decrease the number of unique parts needed to manufacture the delivery apparatus 100 and / or increase interchangeability among the parts of the delivery apparatus 100.

[0178] Now referring to FIG. 5C, the frame 230 can comprise a plurality of struts that includes a first plurality of struts 232, a second plurality of struts 234, a third plurality of struts 236, a fourth plurality of struts 238, a fifth plurality of struts 240, and a sixth plurality of struts 242. The first plurality of struts 232 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged into a first row 244 that extends in a circumferential direction of the frame 230.Each one of the first plurality of struts 232 can be oriented at an angle relative to an axial direction of the frame 230. Each one of the first plurality of struts 232 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the first plurality of stmts 232 can be connected at curved or rounded distal apices 256 that define a distal end of the frame 230. The proximal ends of adjacent ones of the first plurality of stmts 232 can be connected at junctions 258 (which are also referred to herein as “unions”).

[0179] The second plurality of stmts 234 (which are also referred to herein as a “plurality of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”) can be arranged in a second row 246 that extends in the circumferential direction of the frame 230 and is proximally disposed relative to the first row 244. Each one of the second plurality of stmts 234 can be oriented at an angle relative to the axial direction of the frame 230. Each one of the second plurality of stmts 234 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the second plurality of stmts 234 can be connected at the junctions 258. The proximal ends of adjacent ones of the second plurality of stmts 234 can be connected at junctions 260 (which are also referred to herein as “unions”).

[0180] The third plurality of stmts 236 (which are also referred to herein as a “plurality of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”) can be arranged in a third row 248 that extends in the circumferential direction of the frame 230 and is proximally disposed relative to the second row 246. Each one of the third plurality of stmts 236 can be oriented at an angle relative to the axial direction of the frame 230. Each one of the third plurality of stmts 236 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the third plurality of stmts 236 can be connected at junctions 260. The proximal ends of adjacent ones of the third plurality of stmts 236 can be connected at junctions 262 (which are also referred to herein as “unions”).

[0181] The fourth plurality of stmts 238 (which are also referred to herein as a “plurality of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”) can be arranged in a fourth row 250 that extends in the circumferential direction of the frame 230 and is proximally disposed relative to the third row 248. Each one of the fourth plurality of stmts 238 can be oriented at an angle relative to the axial direction of the frame 230. Each one of the fourth plurality of stmts 238 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fourth plurality of stmts 238 can be connected at junctions262. The proximal ends of adjacent ones of the fourth plurality of struts 238 can be connected at junctions 264 (which are also referred to herein as “unions”).

[0182] The fifth plurality of struts 240 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged in a fifth row 252 that extends in the circumferential direction of the frame 230 and is proximally disposed relative to the fourth row 250. Each one of the fifth plurality of stmts 240 can be oriented at an angle relative to the axial direction of the frame 230. Each one of the fifth plurality of stmts 240 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fifth plurality of stmts 240 can be connected at junctions 264. The proximal ends of adjacent ones of the fifth plurality of stmts 240 can be connected at junctions 266 (which are also referred to herein as “unions”).

[0183] The sixth plurality of stmts 242 (which are also referred to herein as a “plurality of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”) can be arranged in a sixth row 254 that extends in the circumferential direction of the frame 230 and is proximally disposed relative to the fifth row 252. Each one of the sixth plurality of stmts 242 can be oriented at an angle relative to the axial direction of the frame 230. Each one of the sixth plurality of stmts 242 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the sixth plurality of stmts 242 can be connected at junctions 266. The proximal ends of adjacent ones of the sixth plurality of stmts 242 can be connected at curved or rounded proximal apices 268 that define a proximal end of the frame 230.

[0184] The stmts of the frame 230 can be arranged and / or connected to form a plurality of cells. For example, the first and second pluralities of stmts 232, 234 can connect to each other to form a first circumferentially-extending row of cells 270. Similarly, the third and fourth pluralities of stmts 236, 238 can be connected to each other to form a second row of cells 272. Similar, the fifth and six pluralities of stmts 240, 242 can be connected to each other to form a third row of cells 274. Although the illustrated frame 230 includes three rows of cells 270, 272, 274, some examples of the frame 230 can include one, two, four, five, six, etc. rows of cells.

[0185] As shown in FIG. 5C, each cell of the frame 230 has a diamond shape. However, in some examples, the stmts of the frame 230 can be arranged to form cells with different shapes (for example, circles, triangles, squares, rectangles, pentagons, hexagons, heptagons, octagons, etc.).

[0186] As shown in FIG. 5A, the frame 230 in its shape set state can include a cylindrical portion formed by the cells 274, a flared region formed by the cells 272 that increases in diameter in a direction extending away from the cells 274, and a tapered region formed by the cells 270 that decreases in diameter in a direction extending away from the cells 272. When used as the frame for the distal valve positioning structure 226, the cylindrical portion (or at least the apices 268) can be fixed to the nose cone 122 or another component of the delivery apparatus. When used as the frame for the proximal valve positioning structure 228, the cylindrical portion (or at least the apices 268) can be fixed to the intermediate shaft 106 or another component of the delivery apparatus (for example, the outer shaft 104).

[0187] As shown in FIG. 5B, the frame 230 in its shape set state can include a constant taper or decrease in diameter along its length from one end to the other end. When used as the frame for the proximal valve positioning structure 228, the frame tapers in a distal-to- proximal direction and the smaller diameter end portion (or at least the apices 268) can be fixed to the intermediate shaft 106 or another component of the delivery apparatus (for example, the outer shaft 104). When used as the frame for the distal valve positioning structure 226, the frame 230 tapers in a proximal-to-distal direction and the smaller diameter end portion (or at least the apices 268) can be fixed to the nose cone 122 or another component of the delivery apparatus.

[0188] The valve positioning structures 226, 228 can be fixed to nose cone 122 and the intermediate shaft 106, respectively, (or to other components of the delivery apparatus) with an adhesive and / or by reflowing the polymer material forming the nose cone 122 and the intermediate shaft 106 such that the polymer material bonds to or encases an adjacent portion of the valve positioning structures 226, 228. In some examples, the valve positioning structures 226, 228 are not physically fixed or attached to the balloon 118 to facilitate inflation of the balloon 1 18. In some examples, in its uninflated state, the balloon 118 is folded to form axially extending pleats or folds to minimize the crimp profile of the balloon 118. By not connecting the balloon 118 directly to the valve positioning structures 226, 228, the balloon 118 can unfold and inflate as an inflation fluid is introduced into the balloon 118.

[0189] Now referring to FIGS. 6A and 6B, there is shown an expandable, external distal valve positioning structure 326 and an expandable, external proximal valve positioning structure 328, respectively, according to one example. The valve positioning structures 326, 328 can each comprise the frame 230. One exemplary difference between the valvepositioning structures 326, 328 and the valve positioning structures 226, 228 shown in FIGS. 5A-5B is that each of the valve positioning structures 326, 328 further comprises a polymeric coating 275 (which is also referred to herein as a “polymeric cover,” a “coating,” and / or a “cover”) disposed on at least one of an inner surface and an outer surface of the frame 230. The polymeric coating 275 can comprise and / or be fomied from any suitable polymer, such any of various synthetic elastomers, such as polyurethane, (for example, Tecoflex™ or NueSoft™), styrene ethylene butylene styrene (SEBS), styrene butadiene styrene (SBS), styrene isoprene styrene (SIS), silicone, silicone-polyurethane blends, or thermoplastic vulcanizate (TPV) (for example, Santoprene). In some examples, the polymeric coating 275 can provide an atraumatic finish that further minimizes potentially traumatic contact with the tissue of the subject’s vasculature.

[0190] In some examples, the polymeric coating 275 can form a liner or layer of material on the inner surface of the frame 230, the outer surface of the frame 230, or both the inner surface and outer surface of the frame 230. In some examples, the frame 230 is encapsulated within the polymeric coating 275. Various techniques (for example, reflow of material extrusions and / or lamination) can be used to form the polymeric coating 275, such as by dipping the frame 230 into the material that forms the polymeric coating 275 when the polymeric coating 275 is in a liquified state. Although the polymeric coating 275 is only shown with reference to FIGS. 6A and 6B, it should be understood that any valve positioning structure disclosed herein can include a polymeric coating (on the inner surface and / or the outer surface of the frame of the valve positioning structure) that shares certain similarities with the polymeric coating 275.

[0191] Now referring to FIG. 7A, there is shown a distal end portion of a delivery apparatus 200, according to one example. One exemplary difference between the delivery apparatus 200 and the delivery apparatus 100 shown in FIGS. 4A-4B is that the delivery apparatus 200 includes at least one suture 276 (for example, a plurality of sutures) connected to the distal valve positioning structure 226. In some examples, the suture 276 (which are also referred to herein as “tethers” and / or “cords”) can extend distally from a proximal end portion of the delivery apparatus 200 (for example, from the handle 102), through the lumen of the intermediate shaft 106, along the outer surface of the balloon 118, and connect to a portion of the distal valve positioning structure 226 (for example, the frame 230 of the distal valve positioning structure 226).

[0192] The at least one suture 276 can be connected to the frame 230 of the distal valve mounting portion 226 using loops, knots, mechanical fasteners, adhesives, etc. For example, as shown in FIG. 7B, an intermediate portion of the suture 276 can be looped around an apex (for example, one of the proximal apices 268 shown in FIG. 5C) of the frame 230. Alternatively, as best shown in FIG. 7C, a distal end of the suture 276 can terminate in a loop 280 that can be secured to a portion of the frame 230 (for example, one of the proximal apices 268 shown in FIG. 5C). In some examples, there can be one suture 276 looped around or otherwise connected to each apex 268.

[0193] In some examples, the at least one suture 276 can be connected to an adjustment member for adjusting tension in the suture 276. For example, the suture 276 can be connected to a rotatable knob coupled to the handle 102 of the delivery apparatus 200. The user can rotate the knob to vary the tension in the suture 276. As noted above, after the prosthetic valve (for example, prosthetic valve 10 or prosthetic valve 150) is deployed and the inflation fluid is removed from the balloon 118, the distal valve positioning structure 226 reverts to its radially compressed state. Tensioning the sutures 276 can further reduce the diameter of the proximal end of the distal valve positioning structure 226 so that the delivery apparatus 200 can be more easily retracted back through an introducer sheath when being removed from the subject’s body.

[0194] Now referring to FIG. 8 A, there is shown a distal end portion of a delivery apparatus 300, according to another example. The illustrated portion of the delivery apparatus 300 includes the intermediate shaft 106, the nose cone 122 distally disposed relative to the intermediate shaft 106, a balloon (such as balloon 118) disposed between the intermediate shaft 106 and the nose cone 122, and the prosthetic valve 150 crimped around the distal end portion of the delivery apparatus 300. One exemplary difference between the delivery apparatus 300 and the previously illustrated delivery apparatuses is that the delivery apparatus 300 includes an expandable, external valve positioning structure 325 that replaces the function of separate distal and proximal valve structures 226, 228. The valve positioning structure 325 extends along an axial length of the balloon). In some examples, the valve positioning structure 325 can extend over the entire axial length of the balloon or substantially (within 10%) the entire axial length of the balloon. The valve positioning structure 325 can be disposed around the balloon of the delivery apparatus 300 and / or coupled to an external surface of the balloon. Desirably, the valve positioning structure 325is not directly physically attached to the balloon to allow the pleats of the balloon to move relative to the valve positioning structure 325 and unfold as the balloon is inflated. The valve positioning structure 325 can be fixed at its distal end to the nose cone 122. The valve positioning structure 325 can be fixed at its proximal end to the distal end portion of the intermediate shaft 106 (for example, an inner surface of the intermediate shaft 106 or an outer surface of the intermediate shaft 106). The prosthetic valve 150 can be mounted or crimped around an intermediate portion of the valve positioning structure 325.

[0195] The valve positioning structure 325 can include a frame 330 defining a distal valve positioning portion 326, a proximal valve positioning portion 328 disposed proximally relative to the distal valve positioning portion 326, and an intermediate valve positioning portion 329 disposed between the distal valve positioning portion 326 and the proximal valve positioning portion 328. The valve positioning structure 325 can be configured such that the intermediate valve positioning portion 329 aligns in an axial direction of the delivery apparatus 300 with the valve mounting portion 124 and / or the intermediate portion 118b of the balloon 118. Thus, when the prosthetic valve 150 is crimped around the delivery apparatus 300, the prosthetic valve 150 can be crimped around the intermediate valve positioning portion 329 and between the distal valve positioning portion 326 and the proximal valve positioning portion 328.

[0196] In some examples, when the prosthetic valve 150 is crimped around the intermediate valve positioning portion 329, none of the distal valve positioning portion 326, the proximal valve positioning portion 328, or the intermediate valve positioning portion 329 overlap the outer surface of the prosthetic valve 150. Furthermore, in some examples, when the prosthetic valve 150 is crimped around the intermediate valve positioning portion 329, no portion of the prosthetic valve 150 touches the outer surface of the balloon 118. In other words, the intermediate valve positioning portion 329 (as well as all other intermediate valve positioning portions disclosed herein) can prevent contact between the prosthetic valve 150 and the outer surface of the balloon 118.

[0197] In some examples, the distal valve positioning portion 326 can have an outer diameter that is greater than an outer diameter of each of the intermediate valve positioning portion 329 and the prosthetic valve 150 in its radially compressed state, as shown in FIG. 8A. In this way, the outer profile of the distal valve positioning portion 326 enables the delivery apparatus 300 to be more easily advanced through an introducer sheath and / or a subject’svasculature in a manner that protects against undesirable contact between the leading edge (the distal end) of the prosthetic valve 150 and the subject’s vasculature and between the leading edge of the prosthetic valve 150 and an inner surface of the introducer sheath.

[0198] In some examples, when the valve positioning structure 325 is in a radially collapsed state, each of the distal valve positioning structure 326 and the proximal valve positioning structure 328 can have an outer diameter that is greater than the outer diameter of each of the intermediate valve positioning portion 329 and the prosthetic valve 150 in its radially compressed state. In this way, the distal and proximal valve positioning portions 326, 328 can be configured to counteract distally- and proximally-directed forces applied by the prosthetic valve 150 during delivery of the prosthetic valve 150, thereby maintaining the positioning of the prosthetic valve 150 on the balloon 118 as it is advanced through an introducer sheath and the subject’s vasculature.

[0199] Now referring to FIG. 8B, the distal valve positioning portion 326, the proximal valve positioning portion 328, and the intermediate valve positioning portion 329 can be connected to form the frame 330, which can comprise a plurality of struts arranged into a plurality of cells. In some examples, the frame 330 can be a unitary and / or fastener-free structure. In some examples, the distal valve positioning portion 326, the proximal valve positioning portion 328, and the intermediate valve positioning portion 329 can comprise and / or be formed from a single piece of material (for example, Nitinol), such as in the form of a tube. In such an example, the valve positioning structure 325 and / or the frame 330 can be formed by removing portions (for example, via laser cutting) of the single piece of material.

[0200] The frame 330 of the valve positioning structure 325 (and all other frames of valve positioning structures disclosed herein) can be made of a shape memory material, such as Nitinol. When made of such a shape memory material, the frame 330 (and all other frames disclosed here) can be shape set in the radially collapsed state (FIGS. 8 A and 8B), and can radially expand to a radially expanded state under the force of the inflating balloon and then radially collapse back to the radially collapsed state under its own resiliency when the balloon is deflated.

[0201] Another advantage of the valve positioning structure 325 (and other valve positioning structures disclosed herein) is that the frame 330, when made of a metal (such as Ninitol), the frame 330 is visible under fluoroscopy and therefore the frame 330 (or portions thereof) can be used as positioning or alignment device for positioning the prosthetic valve relative to theintended implantation site. Thus, in some examples, the balloon can be inflated with a clear inflation fluid (such as saline) without a contrast solution, which typically is used in valve implantation procedures to make the balloon visible under fluoroscopy. In some examples, the use of a clear inflation fluid (which in some examples can be less allergenic than contrast solution) to inflate the balloon can further reduce the likelihood of potential complications (for example, allergic reactions to contrast solution) if the balloon bursts or leaks during the implantation process.

[0202] FIGS. 9A-9C illustrate a distal end portion of a delivery apparatus 400 during different stages of a prosthetic valve implantation procedure, according to one example. Now referring to FIG. 9A, there is shown the delivery apparatus 400 before the prosthetic valve 150 is mounted or crimped around the distal end portion of the delivery apparatus 400. The delivery apparatus 400 can include the intermediate shaft 106, the nose cone 122 disposed distally relative to the intermediate shaft 106, and the balloon 118 (FIGS. 9B-9C) in a deflated state. One exemplary difference between the delivery apparatus 400 and the delivery apparatus 300 of FIGS. 8A-8B is that the delivery apparatus 400 includes an expandable, external valve positioning structure 425.

[0203] The valve positioning structure 425 can include a distal valve positioning portion 426, a proximal valve positioning portion 428 proximally disposed relative to the distal valve positioning portion 426, and an intermediate valve positioning portion 429 disposed between the distal valve positioning portion 426 and the proximal valve positioning portion 428. As shown, an outer diameter of each of the distal valve positioning portion 426 and the proximal valve positioning portion 428 is larger than an outer diameter of the intermediate valve positioning portion 429 when the valve positioning structure 425 is in a radially collapsed state.

[0204] One exemplary difference between the valve positioning structure 425 and the valve positioning structure 325 shown in FIGS. 8A-8B is that the illustrated valve positioning structure 425 comprises a braided mesh structure 430. In some examples, the braided mesh structure 430 can be formed by braiding one or more wires (for example, Nitinol wires). The braided mesh structure 430 is shape set in a radially collapsed state (FIG. 9A) and is configured to radially expand to a radially expanded state (FIG. 9C) as the balloon is inflated. As the inflation fluid is removed from the balloon, the braided mesh structure 430 can return to the radially collapsed state under its own resiliency.

[0205] Now referring to FIG. 9B, there is shown the distal end portion of the delivery apparatus 400, wherein the balloon 118, the prosthetic valve 150, and the valve positioning structure 425 are each in a partially radially expanded state (which is also referred to herein as a “partially radially collapsed state” and / or “partially radially compressed state”) between the radially compressed state and the radially expanded state. As shown, the outer diameter of each of the distal valve positioning portion 426 and the proximal valve positioning portion 428 is larger than the outer diameter of the intermediate valve positioning portion 429 when the valve positioning structure 425 is in the partially radially expanded state. In this way, the valve mounting structure 425 can help keep the prosthetic valve 150 aligned in an axial direction of the delivery apparatus 400 with the valve mounting portion 124 as the balloon 118 is inflated. When the prosthetic valve 150 is crimped around the intermediate valve positioning portion 429 and when the balloon 118 is partially radially expanded, none of the distal valve positioning portion 426, the proximal valve positioning portion 428, or the intermediate valve positioning portion 429 overlap the outer surface of the prosthetic valve 150.

[0206] Now referring to FIG. 9C, there is shown the distal end portion of the delivery apparatus 400, wherein the balloon 118, the prosthetic valve 150, and the valve positioning structure 425 are each in the radially expanded state. As shown, the outer diameter of each of the distal valve positioning portion 426 and the proximal valve positioning portion 428 is substantially the same as the outer diameter of the intermediate valve positioning portion 429 when the valve positioning structure 425 is in the radially expanded state. For example, the outer diameter of each of the distal valve positioning portion 426 and the proximal valve positioning portion 428 can be within 10% of the outer diameter of the intermediate valve positioning portion 429 when the valve positioning structure 425 is in the radially expanded state. In this way, the prosthetic valve 150 can be uniformly expanded along its axial length by the expansion of the balloon 118 and / or the valve positioning structure 425. In some examples, the uniform expansion of the balloon 118 and / or the valve positioning structure 425 can help minimize and / or prevent axial migration (for example, distal migration) of the prosthetic valve 150.

[0207] FIGS. 10A-10E illustrate an expandable, external valve positioning structure 525, according to one example. Now referring to FIG. 10A, the valve positioning structure 525 — shown in a radially collapsed state — comprises a frame 530 defining a distal valvepositioning portion 526, a proximal valve positioning portion 528 proximally disposed relative to the distal valve positioning portion 526, and an intermediate valve positioning portion 529 disposed between the distal valve positioning portion 526 and the proximal valve positioning portion 528.

[0208] In some examples, the distal valve positioning portion 526 can have a tapered shape. For example, as shown in FIG. 10A, the distal end portion of the distal valve positioning portion 526 defines a first diameter DI and the proximal end portion of the distal valve positioning portion 526 defines a second diameter D2. As shown, D2 can be greater than DI such that the distal valve positioning portion 526 tapers towards the distal end portion of the valve positioning structure 525. Such a configuration can result in the distal valve positioning portion 526 having a frustoconical shape that tapers to towards the distal end portion of the valve positioning structure 525.

[0209] The proximal valve positioning portion 528 can have a tapered shape. For example, as shown, the distal end portion of the proximal valve positioning portion 528 defines a fourth diameter D4 and the proximal end portion of the proximal valve positioning portion 528 defines a fifth diameter D5. As shown, D4 can be greater than D5 such that the proximal valve positioning portion 528 tapers towards the proximal end portion of the valve positioning structure 525. Such a configuration can result in the proximal valve positioning portion 528 having a frustoconical shape that tapers to towards the proximal end portion of the valve positioning structure 525.

[0210] As shown, the intermediate valve positioning portion 529 can have a cylindrical shape. For example, as shown the intermediate valve positioning portion 529 can define a third diameter D3 that is constant or a substantially constant (within 10%) along the axial length of the intermediate valve positioning portion 529. In some examples, the intermediate valve positioning portion 529 can define a third diameter D3 that varies no more than 10% along the axial length of the intermediate valve positioning portion 529. In some examples, at least one of the region between the distal valve positioning portion 526 and the intermediate valve positioning portion 529 and the region between the proximal valve positioning portion 528 and the intermediate valve positioning portion 529 can be flared. In some examples, the flared region can define a shoulder (for example, a distal shoulder or a proximal shoulder) of the valve positioning structure 525. For example, as shown, the second diameter D2 of the distal valve positioning portion 526 is greater than the third diameter D3of the intermediate valve positioning portion 529. As further shown, the fourth diameter D4 of the proximal valve positioning portion 528 is greater than the third diameter D3 of the intermediate valve positioning portion 529. In some examples, forming a flared region on the valve positioning structure 525 can help further reduce axial movement of an implant (such as the prosthetic valve 10 or the prosthetic valve 150) mounted around the intermediate valve positioning portion 529.

[0211] As shown in FIG. 10A, the first diameter DI, the third diameter D3, and the fifth diameter D5 can be equal or substantially equal (within 10%). For example, the first diameter DI, the third diameter D3, and the fifth diameter D5 can be within 10% of each other. For example, DI, D3, and D5 can be equal or substantially equal to the outer diameter of a balloon (for example, the balloon 118) in a radially collapsed or deflated state in order to further minimize the outer diameter of the valve positioning structure 525. In some examples, the third diameter D3 can be greater than each one of the first diameter DI and the second diameter D2. In some examples, the third diameter D3 can be less than each one of the first diameter DI and the second diameter D2. In some examples, the third diameter D3 can be greater than each one of the fourth diameter D4 and the fifth diameter D5. In some examples, the third diameter D3 can be less than each one of the fourth diameter D4 and the fifth diameter D5.

[0212] Now referring to FIG. 10B, there is shown a flattened view of the frame 530. As shown, each of the distal valve positioning portion 526 and the proximal valve positioning portion 528 comprises the same arrangement of struts and / or cells, such that the frame 530 is axially symmetric about the intermediate valve positioning portion 529. However, in some examples, one of the distal valve positioning portion 526 and the proximal valve positioning portion 528 can include a different arrangement of struts and / or cells.

[0213] The frame 530 can be shape set in the radially collapsed state shown in FIG. 10A to form the valve positioning structure 525. It should be understood that any frame disclosed herein that includes a proximal portion, a distal portion, and an intermediate portion (for example, any one of frames 1030, 1130, 1230, 1330, 1430, 1530, 1630. 1730, 1830, 1930, 2030, 2130, 2230, and 2330) can be shape set in the radially collapsed state to form a valve positioning structure having a similar shape as valve positioning structure 525 shown in FIG. 10A.

[0214] As shown, each of the distal valve positioning portion 526 and the proximal valve positioning portion 528 comprises a plurality of struts that includes a first plurality of struts 532 and a second plurality of struts 534. Each one of the first plurality of struts 532 (which are also referred to herein as a “plurality of angled linear struts,’’ a “plurality of angled struts,” and / or a “plurality of linear struts”) can have a linear shape and can be oriented at an angle relative to an axial direction of the frame 530. The first plurality of struts 532 can be arranged into one or more rows 570 that extend in a circumferential direction of the frame 530 with the junctions between adjacent ends of the first plurality of stmts 532 pointing either in the distal or proximal directions. For example, as shown, the first plurality of stmts 532 are arranged into four rows 570. However, the first plurality of stmts 532 can be arranged into any other number of rows (for example, one row, two rows, three rows, five rows, six rows, etc.) in some examples of the frame 530.

[0215] Each one of the second plurality of stmts 534 (which are also referred to herein as a “plurality of zig-zag stmts,” a “plurality of z-stmts,” and / or a “plurality of jagged stmts”) can have a zigzag or sawtooth shape. The plurality of second stmts 534 be arranged into one or more rows 572 that extends in a circumferential direction of the frame 530 with the peaks formed along each of the plurality of second stmts 534 pointing in the circumferential direction. For example, as shown, the second plurality of stmts 534 are arranged into three rows 572. However, the second plurality of struts 534 can be arranged into any other number of rows (for example, one row, two rows, four rows, five rows, six rows, etc.) in some examples of the frame 530.

[0216] As shown, rows 570, 572 of the first and second pluralities of stmts 532, 534 are arranged in an alternating pattern. In some examples, the illustrated arrangement of alternating rows 570, 572 can improve the flexibility of the valve positioning structure 525 while providing sufficient axial stiffness to support the balloon 118 and / or the prosthetic valve 150. For example, the first plurality of stmts 532 can support the balloon 118 and / or the prosthetic valve 150, while the second plurality of stmts 534 can bend when the valve positioning stmcture 525 is manipulated and subjected to external forces during use. Such an arrangement can better enable the valve positioning stmcture 525 to be more easily advanced through an introducer sheath and / or a subject’s vasculature (for example, at or around the aortic arch).

[0217] The intermediate valve positioning portion 529 can comprise a third plurality of struts 536 (which are also referred to herein as a “plurality of axial linear struts,’’ a “plurality of connecting struts,” a “plurality of intermediate connecting struts,” and / or a “plurality of intermediate stmts”) that connect the distal valve positioning portion 526 and the proximal valve positioning portion 528. In some examples, the third plurality of stmts 536 can help minimize interactions between the frame 530 and a prosthetic heart valve’s leaflets (for example, leaflets 40 of prosthetic heart valve 10 or leaflets of valve 150). Each one of the third plurality of stmts 536 can include a distal end and a proximal end. As shown, each one of the third plurality of stmts 536 connects at its distal end to a junction of two stmts 532 at the distal valve positioning portion 526. As further shown, each one of the third plurality of stmts 536 connects at its proximal end to a junction of two of the first plurality of stmts 532 at the proximal valve positioning portion 528.

[0218] In some examples, the frame 530 can be a unitary and / or fastener-free stmcture that can comprise and / or be formed from a single piece of material (for example, Nitinol), such as in the form of a tube. The frame 530 can comprise the plurality of stmts (for example, pluralities of stmts 532, 534, 536) formed into a plurality of cells. The plurality of stmts and / or cells can be formed by removing portions (for example, via laser cutting) of the single piece of material.

[0219] Now referring to FIG. 10C, there is shown the valve positioning structure 525 mounted to a distal end portion of a delivery apparatus 500. The delivery apparatus 500 includes the intermediate shaft 106, the nose cone 122 disposed distally relative to the intermediate shaft 106, and the balloon 118 coupled to the intermediate shaft 106 and / or the nose cone 122. The balloon 118 is shown in the deflated state.

[0220] As shown, the valve positioning stmcture 525 is mounted around the balloon 118 (for example, to an external surface of the balloon 118). As further shown, the distal end of the distal valve positioning portion 526 can be fixed to the nose cone 122 and the proximal end of the proximal valve positioning portion 528 can be fixed to the intermediate shaft 106 (for example, an interior or external surface of a distal end of the intermediate shaft 106). As further shown, the intermediate valve positioning portion 529 is aligned in an axial direction of the delivery apparatus 500 with the valve mounting portion 124 and / or the intermediate portion 118b of the balloon 118.

[0221] Now referring to FIG. 10D, there is shown the prosthetic valve 150 in its radially compressed state mounted to the distal end portion of the delivery apparatus 500. The prosthetic valve 150 can be mounted and / or crimped around the intermediate valve positioning portion 529 of the valve positioning structure 525 when the balloon 118 is in the deflated state, such that the prosthetic valve 150 is disposed between the distal valve positioning portion 526 and the proximal valve positioning portion 528. As shown, none of the distal valve positioning portion 526, the proximal valve positioning portion 528, or the intermediate valve positioning portion 529 overlap the outer surface of the prosthetic valve 150. In some examples, one or more portions of the valve positioning structure 525 can overlap a portion of the prosthetic valve 150.

[0222] As further shown, in the illustrated example, the intermediate valve positioning portion 529 prevents the prosthetic valve 150 from contacting the balloon 118. In some examples, the distal valve positioning portion 526 enables the delivery apparatus 100 to be more easily advanced through an introducer sheath and / or a subject’s vasculature in a manner that protects against undesirable contact between the leading edge (the distal end) of the prosthetic valve 150 and the subject’s vasculature and between the leading edge of the prosthetic valve 150 and an inner surface of the introducer sheath. In some examples, the proximal valve positioning portion 528 can be configured to counteract proximally-directed forces applied by the prosthetic valve 150 during delivery of the valve 150, thereby maintaining the positioning of the prosthetic valve 150 on the balloon 118 as it is advanced through an introducer sheath and the subject’s vasculature.

[0223] Now referring to FIG. 10E, there is shown the prosthetic valve 150 mounted to the distal end portion of the delivery apparatus 500, wherein, the balloon 118, the prosthetic valve 150, and the valve positioning structure 525 are in radially expanded states. As shown, the intermediate valve positioning portion 529 is cylindrical when the valve positioning structure 525 is in the radially expanded state. As further shown, the distal valve positioning portion 526 tapers from the intermediate valve positioning portion 529 to the nose cone 122 and the proximal valve positioning portion 528 tapers from the intermediate valve positioning portion 529 to the intermediate shaft 106 when the valve positioning structure 525 is in the radially expanded state.

[0224] Known delivery apparatuses used for delivering balloon-expandable prosthetic valve heart valves typically include balloons with relatively long distal and proximal sections thatextend beyond the distal and proximal ends of the prosthetic valve. These distal and proximal balloon sections typically are inflated at a faster rate than the central section of the balloon on which the prosthetic valve is mounted. As a result, the balloon can assume a “dog bone” shape as it is being inflated such that the distal and proximal sections can be inflated to a greater diameter than the prosthetic valve, at least initially. This is advantageous in that the distal and proximal balloon sections help fix the position of the prosthetic valve on the balloon and minimize shifting of the prosthetic valve relative to the balloon as the balloon is inflated to deploy the prosthetic valve. However, the relatively long balloon can be make navigating a subject’s vasculature more difficult and may contact portions of the subject’s vasculature (for example, the sinotubular junction (STJ) and / or the left ventricular outflow tract (LVOT)) during a prosthetic valve implantation procedure.

[0225] Now referring to FIG. 11 , there is shown a distal end portion of a delivery apparatus 600. As shown, the delivery apparatus 600 includes the intermediate shaft 106, the inner shaft 108 extending coaxially through the intermediate shaft 106 to the nose cone 122, and a balloon 218 disposed around the inner shaft 108 and between the intermediate shaft 106 and the nose cone 122. The delivery apparatus 600 also includes an expandable, external valve positioning structure 625. Desirably, although not necessarily, no portion of the valve positioning structure 625 overlaps the outer surface of the prosthetic valve 150.

[0226] One exemplary difference between the balloon 218 and the previously illustrated balloon 118 is that the balloon 218 has a shorter axial length than the balloon 118. In some examples, the shorter axial length of the balloon 218 can help the delivery apparatus 600 better navigate the subject’s vasculature to avoid contact with portions of the subject’s vasculature (for example, the sinotubular junction (STJ) and / or the left ventricular outflow tract (LVOT)) during a prosthetic valve implantation procedure. Thus, the shorter axial length of the balloon 218 can help further minimize the risk of rupture and / or conduction disturbances at these locations within the subject’s vasculature.

[0227] Similarly, one exemplary difference between the valve positioning structure 625 and the previously illustrated valve positioning structure 525 is that the valve positioning structure 625 has a shorter axial length than the valve positioning structure 525. In some examples, the valve positioning structure 625 can have the same overall construction and shape (in the expanded and collapsed states) as the valve positioning structure 525, except that the valve positioning structure 625 is shorter than the valve positioning structure 525.

[0228] FIG. 12 is a schematic profile view of four exemplary balloons for a delivery apparatus, according to one example. In particular, FIG. 12 offers a side-by-side comparison of the axial lengths (from the proximal-most end of the balloon to the distal-most end of the balloon) of the balloon 118 (which is also referred to herein as a “first balloon”), the balloon 218 (which is also referred to herein as a “second balloon”), a balloon 318 (which is also referred to herein as a “third balloon”), and a balloon 418 (which is also referred to herein as a “fourth balloon”). In some examples, the intermediate section (in other words, the valve mounting portion) of each of the second, third, and fourth balloons 218, 318, and 418, respectively, can have a length that is equal to or substantially equal (within 10%) to the length of the prosthetic valve in its radially compressed state. The balloon 218, 318, and 418 can be selected based on the size of the prosthetic valve to be implanted.

[0229] The first balloon 118 can have a first axial length, which can be in a range from 51 mm to 57 mm, such as from 52 mm to 56 mm, from 54 mm to 55 mm, and / or 54.5 mm.

[0230] The second balloon 218 can have a second axial length, which can be in a range from 45 mm to 51 mm, such as from 46 mm to 50 mm, from 47 mm to 49 mm, 47 mm to 48 mm, and / or 47.3 mm.

[0231] The third balloon 318 can have a third axial length, which can be in a range from 31 mm to 45 mm, such as from 32 mm to 44 mm, from 33 mm to 43 mm, from 34 mm to 42 mm, from 31 mm to 37 mm, from 32 mm to 36 mm, from 33 mm to 35 mm, and / or 34 mm.

[0232] The fourth balloon 418 can have a fourth axial length, which can be in a range from 25 mm to 31 mm, such as from 26 mm to 30 mm, from 27 mm to 29 mm, and / or 28 mm.

[0233] In some examples, delivery apparatuses that include a valve positioning structure (for example, any one of the disclosed valve positioning structures) can be compatible with any one of the first balloon 118, the second balloon 218, the third balloon 318, or the fourth balloon 418. In some examples, a distal end portion of a delivery apparatus that includes both a valve positioning structure and one of the second balloon, 218, third balloon 318, or fourth balloon 418 can be more easily advanced through the subject’s vasculature (for example, in and / or around the sinotubular junction and / or the left ventricular outflow tract) than a distal end portion of a delivery apparatus that includes a relatively axially longer balloon.

[0234] Now referring to FIG. 13, there is shown a flattened view of a frame 730 of an expandable, external valve positioning structure, according to one example. In someexamples, the frame 730 can be shape set to form any one of a distal valve positioning structure or a proximal valve positioning structure similar to those shown in FIGS. 5A-5B. In some examples, the frame 730 can be used to form a valve positioning structure that includes both proximal and distal valve positioning portions interconnected to each other with an intermediate portion, for example, an intermediate portion comprising axial stmts 536.

[0235] The frame 730 can comprise a plurality of stmts 732. Each one of the plurality of stmts 732 can comprise a first end portion 733 oriented parallel to an axial direction of the frame 730 and a second end portion 735 oriented parallel to the axial direction of the frame 730. As shown, the first end portion 733 is offset in a circumferential direction from the second end portion 735. Each one of the plurality of stmts 732 can further comprise an intermediate portion 737 oriented at an angle relative to the axial direction of the frame 730. The cross-sectional width of each one of the plurality of stmts 732 can vary along its length. For example, as shown, the cross-sectional width of each one of the plurality of stmts 732 is wider at the first and second end portions 733, 735 than at the intermediate portion 737 disposed between the first and second end portions 733, 735. In some examples, the reduced cross-section at the intermediate portion 737 can better allow the plurality of stmts 732 to bend or flex, which can beneficially result in a more flexible frame 730 that can be more easily navigated through the subject's vasculature.

[0236] Adjacent ones of the plurality of stmts 732 can form apices 766 at the axial ends of the frame 730. The apices 766 can be formed by the second end portions 735 of adjacent ones of the plurality of stmts 732. As shown, each apex 766 can form a circular head 767. In some examples, the rounded shape of the circular head 767 can make it easier to advance the delivery apparatus. In some examples, the atraumatic shape of the circular head 767 can further minimize potential damage to the prosthetic valve and / or the balloon when the circular head 767 contacts the prosthetic valve and / or balloon during inflation. In between the axial ends of the frame 730, adjacent ones of the plurality of stmts 732 can connect with three other ones of the plurality of stmts 732 at junctions 762 (which are also referred to herein as “unions”). Each junction 762 can comprise four of the plurality of struts 732 that connect via a crossbar 763 extending in a circumferential direction of the frame 730 to form an H-shaped arrangement of stmts.

[0237] As shown, the frame 730 is symmetric in the axial direction of the frame 730. Thus, each axial end of the frame 730 can be either the proximal end of the frame 730 or the distalend of the frame 730. Similarly, apices 766 can be either the proximal apices or distal apices of the frame 730. In this way, the frame 730 can be used to form either a proximal valve positioning structure or a distal valve positioning structure and / or can be invertible.

[0238] In some examples, the frame 730 can form a distal valve positioning structure or a proximal valve positioning structure and can be shape set such as shown in either FIG. 5A or FIG. 5B. In some examples, a valve positioning structure can comprise a first frame 730 forming a proximal portion of the valve positioning structure, a second frame 730 forming a distal portion of the valve positioning structure, and an intermediate portion (for example, a plurality of axial struts 536) interconnecting the first and second frames 730.

[0239] Now referring to FIG. 14A, there is shown an expandable, external proximal valve positioning structure 828, according to one example. The valve positioning structure 828 can comprise a frame 830. In some examples, the frame 830 can be used to form either the proximal valve positioning structure or an expandable, external distal valve positioning structure. In some examples, the proximal valve positioning structure 828 can comprise the frame 830 having a first stiffness and the distal valve positioning structure can comprise a second, different frame having a second stiffness. In some examples, the second stiffness can be less than the first stiffness such that the distal valve positioning structure expands and / or collapses first, which can better facilitate retrieval of a distal end portion of a delivery apparatus around which the proximal valve positioning structure 828 is mounted.

[0240] Now referring to FIG. 14B, there is shown the frame 830 of the proximal valve positioning structure 828, wherein the frame 830 is shown in a flattened configuration. Although the frame 830 is primarily shown with reference to the proximal valve positioning structure 828, the frame 830 can be used to fomr a distal valve positioning structure or any other valve positioning structure (for example, a valve positioning structure that includes both proximal and distal valve positioning portions interconnected to each other with an intermediate portion, such as an intermediate portion comprising axial struts 536).

[0241] The frame 830 can comprise a plurality of stmts that includes a first plurality of stmts 832, a second plurality of stmts 834, a third plurality of stmts 836, a fourth plurality of struts 838, a fifth plurality of stmts 840, and a sixth plurality of stmts 842. The first plurality of stmts 832 (which are also referred to herein as a “plurality of axial linear stmts,” a “plurality of axial stmts,” and / or a “plurality of linear stmts”) can be arranged into a first row 844 that extends in a circumferential direction of the frame 830. Each one of the first plurality ofstruts 832 can be oriented in an axial direction of the frame 830. Each one of the first plurality of struts 832 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the first plurality of struts 832 can be connected at semicircular distal apices 856 that define a distal end of the frame 830. The proximal ends of adjacent ones of the first plurality of struts 832 can be connected at junctions 858 (which are also referred to herein as “unions”).

[0242] The second plurality of struts 834 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial stmts,” and / or a “plurality of linear stmts”) can be arranged into a second row 846 that extends in the circumferential direction of the frame 830. Each one of the second plurality of stmts 834 can be oriented in the axial direction of the frame 830. Each one of the second plurality of stmts 834 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the second plurality of stmts 834 can be connected at the junctions 858. Each junction 858 can be formed by connecting the axially- extending proximal ends of two adjacent ones of the second plurality of stmts 834 and the axially-extending distal ends of two adjacent ones of the second plurality of stmts 834 via a crossbar 863 that extends in the circumferential direction of the frame 830 to form an H- shaped arrangement of stmts. The proximal ends of adjacent ones of the first plurality of stmts 832 can be connected at junctions 860 (which are also referred to herein as “unions”).

[0243] The third plurality of struts 836 (which are also referred to herein as a “plurality of axial linear stmts,” a “plurality of axial stmts,” and / or a “plurality of linear stmts”) can be arranged into a third row 848 that extends in the circumferential direction of the frame 830. Each one of the third plurality of stmts 836 can be oriented in the axial direction of the frame 830. Each one of the third plurality of stmts 836 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the third plurality of stmts 836 can be connected at junctions 860. The proximal ends of adjacent ones of the third plurality of stmts 836 can be connected at junctions 862 (which are also referred to herein as “unions”). Similar to the junctions 858, each junction 862 can include four stmts (for example, two adjacent ones of the third plurality of stmts 836 and two adjacent ones of the fourth plurality of struts 838) connected by the crossbar 863 to form the H-shaped arrangement of stmts.

[0244] The fourth plurality of stmts 838 (which are also referred to herein as a “plurality of axial linear stmts,” a “plurality of axial stmts,” and / or a “plurality of linear stmts”) can be arranged into a fourth row 850 that extends in the circumferential direction of the frame 830.Each one of the fourth plurality of struts 838 can be oriented in the axial direction of the frame 830. Each one of the fourth plurality of struts 838 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fourth plurality of struts 838 can be connected at junctions 862. The proximal ends of adjacent ones of the fourth plurality of struts 838 can be connected at junctions 864 (which are also referred to herein as “unions”).

[0245] The fifth plurality of struts 840 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial struts,” and / or a “plurality of linear struts”) can be arranged into a fifth row 852 that extends in the circumferential direction of the frame 830. Each one of the fifth plurality of struts 840 can be oriented in the axial direction of the frame 830. Each one of the fifth plurality of struts 840 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fifth plurality of struts 840 can be connected at junctions 864. The proximal ends of adjacent ones of the fifth plurality of struts 840 can be connected at junctions 866 (which are also referred to herein as “unions”). Similar to the junctions 858, 862, each junction 866 can include four struts (for example, two adjacent ones of the fifth plurality of struts 840 and two adjacent ones of the sixth plurality of struts 842) connected by the crossbar 863 to form the H-shaped arrangement of struts.

[0246] The sixth plurality of struts 842 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial stmts,” and / or a “plurality of linear stmts”) can be arranged into a sixth row 854 that extends in the circumferential direction of the frame 830. Each one of the sixth plurality of stmts 842 can be oriented in the axial direction of the frame 830. Each one of the sixth plurality of stmts 842 can comprise a distal end and a proximal end. The proximal ends of adjacent ones of the sixth plurality of stmts 842 can be connected at semicircular proximal apices 868 that define a proximal end of the frame 830. The distal ends of adjacent ones of the sixth plurality of stmts 842 can be connected at junctions 866.

[0247] The stmts of the frame 830 can be arranged and / or connected to form a plurality of cells. For example, the first and second pluralities of stmts 832, 834 can connect to each other to form a first circumferentially-extending row of cells 870. Similarly, the third and fourth pluralities of struts 836, 838 can be connected to each other to form a second row of cells 872. Similar, the fifth and six pluralities of stmts 840, 842 can be connected to each other to form a third row of cells 874. Although the illustrated frame 830 includes three rows of cells 870, 872, 874, some examples of the frame 830 can include one, two, four, five, six, etc. rows of cells.

[0248] As shown, each cell of the frame 830 has a “stadium” or “capsule” shape that includes two parallel sides defining the circumferential ends of each cell and two semicircular ends defining the axial ends of each cell. However, in some examples, the struts of the frame 830 can be arranged to form cells with different shapes (for example, circles, triangles, diamonds, squares, rectangles, pentagons, hexagons, heptagons, octagons, etc.).

[0249] Now referring to FIG. 15, there is shown a frame 930 in a flattened configuration for a valve positioning structure, according to one example. In some examples, the frame 930 can be formed into either one of a proximal valve positioning structure or a distal valve positioning structure, and optionally can be shape set as shown in either FIG. 5A or FIG. 5B. In some examples, a valve positioning structure can comprise a first frame 930 forming a proximal portion of the valve positioning structure, a second frame 930 forming a distal portion of the valve positioning structure, and an intermediate portion (for example, a plurality of axial struts 536) interconnecting the first and second frames.

[0250] The frame 930 can share certain similarities with the frame 230 that is best illustrated in FIG. 5C. One exemplary difference between the frame 930 and the frame 230 is that the frame 930 includes a fourth row of cells 982 at a distal end of the frame 930. Each cell 982 can comprise a box-shaped head 986 and a connecting strut 984 extending between the boxshaped head 986 and a corresponding distal apex 256. In some examples, fabric, cloth, foam, and / or any padding can be coupled to any of the box-shaped heads 986, such as by stitching the fabric, cloth, foam or padding to the heads 986 with sutures. In some examples, the fabric, cloth, foam, or padding can cover the heads 986. In some examples, when the frame 930 is formed into a proximal valve positioning structure and is connected to a shaft of the delivery apparatus (for example, the shaft 104), the heads 986 and the attached fabric, cloth, foam and / or padding can form a distal tip portion (similar to tip portion 128) that can help position the prosthetic heart valve 150 on the balloon 118 in an off-balloon delivery procedure, similar to that shown in FIG. 2B. The fourth row of cells 982 can be disposed closest to the prosthetic valve 150 when the frame 930 is formed into a proximal valve positioning structure and coupled to a delivery apparatus. For example, when the frame 930 is formed into a proximal valve positioning structure, the resulting valve positioning structure can be configured such that the fourth row of cells 982 (in particular, the box -shaped heads 986 of the fourth row of cells 982) beneficially form a more continuous surface to contact a proximal end of the prosthetic valve 150. In some examples, the frame 930 can be invertedsuch that the fourth row of cells 982 is at a proximal end of the frame 930. In this way, when the frame 930 is formed into a distal valve positioning structure, the resulting valve positioning structure can be configured such that the fourth row of cells 982 (in particular, the box-shaped heads 986 of the fourth row of cells 982) beneficially form a more continuous surface to contact a distal end of the prosthetic valve 150.

[0251] FIG. 16 is a flattened view of a frame 1030 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1030 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10 A). The frame 1030 comprises a distal valve positioning portion 1026, a proximal valve positioning portion 1028, and an intermediate valve positioning portion 1029 disposed therebetween.

[0252] The distal valve positioning portion 1026 can include a plurality of struts that includes a first plurality of struts 1082 and a second plurality of struts 1084. The first plurality of struts 1082 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged into a first row 1092 that extends in a circumferential direction of the frame 1030. Each one of the first plurality of struts 1082 can be oriented at an angle relative to an axial direction of the frame 1030. Each one of the first plurality of struts 1082 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the first plurality of struts 1032 can be connected at curved or rounded distal apices 1083d that define a distal end of the distal valve positioning portion 1026 and / or the frame 1030. The proximal ends of adjacent ones of the first plurality of struts 1082 can be connected at curved or rounded apices 1083p.

[0253] The second plurality of struts 1084 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged into a second row 1094 that extends in the circumferential direction of the frame 1030. The second row 1094 can be proximally disposed relative to the first row 1092. Each one of the second plurality of struts 1084 can be oriented at an angle relative to the axial direction of the frame 1030. Each one of the second plurality of struts 1084 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the second plurality of struts 1084 can be connected at curved or rounded apices 1085d. The proximal ends of adjacent ones of the second plurality of stmts 1084 can be connected at curved or roundedproximal apices 1085p that define a proximal end of the distal valve positioning portion 1026.

[0254] The distal valve positioning portion 1026 can further include a plurality of connecting stmts 1063 (which are also referred to herein as a “plurality of axial linear connecting stmts,” a “plurality of axial connecting stmts,” and / or a “plurality of linear connecting stmts”). Each one of the plurality of connecting stmts 1063 can extend in an axial direction of the frame 1030 from one of the distal apices 1083d to an axially adjacent one of apices 1085p. As shown, the plurality of connecting stmts 1063 connect every third distal apex 1083d and apex 1085p in the circumferential direction. However, the plurality of connecting stmts 1063 can be arranged to connect any number of apices 1083d, 1085p. In some examples, the distal valve positioning portion 1026 can be longer in an axial direction than the proximal valve positioning portion 1028.

[0255] The proximal valve positioning portion 1028 can comprise a plurality of stmts that includes a first plurality of stmts 1032, a second plurality of stmts 1034, a third plurality of stmts 1036, a fourth plurality of stmts 1038, a fifth plurality of stmts 1040, and a sixth plurality of stmts 1042. The first plurality of stmts 1032 (which are also referred to herein as a “plurality of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”) can be arranged into a first row 1044 that extends in the circumferential direction of the frame 1030. Each one of the first plurality of stmts 1032 can be oriented at an angle relative to the axial direction of the frame 1030. Each one of the first plurality of stmts 1032 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the first plurality of stmts 1032 can be connected at curved or rounded distal apices 256 that define a distal end of the proximal valve positioning portion 1028. The proximal ends of adjacent ones of the first plurality of stmts 1032 can be connected at junctions 1058 (which are also referred to herein as “unions”).

[0256] The second plurality of stmts 1034 (which are also referred to herein as a “plurality of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”) can be arranged in a second row 1046 that extends in the circumferential direction of the frame 1030 and is proximally disposed relative to the first row 1044. Each one of the second plurality of stmts 1034 can be oriented at an angle relative to the axial direction of the frame 1030. Each one of the second plurality of stmts 1034 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the second plurality of stmts 1034 can be connected at thejunctions 1058. The proximal ends of adjacent ones of the second plurality of struts 1034 can be connected at junctions 1060 (which are also referred to herein as “unions”).

[0257] The third plurality of struts 1036 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged in a third row 1048 that extends in the circumferential direction of the frame 1030 and is proximally disposed relative to the second row 1046. Each one of the third plurality of struts 1036 can be oriented at an angle relative to the axial direction of the frame 1030. Each one of the third plurality of struts 1036 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the third plurality of stmts 1036 can be connected at junctions 1060. The proximal ends of adjacent ones of the third plurality of stmts 1036 can be connected at junctions 1062 (which are also referred to herein as “unions”).

[0258] The fourth plurality of stmts 1038 (which are also referred to herein as a “plurality of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”) can be arranged in a fourth row 1050 that extends in the circumferential direction of the frame 1030 and is proximally disposed relative to the third row 1048. Each one of the fourth plurality of stmts 1038 can be oriented at an angle relative to the axial direction of the frame 1030. Each one of the fourth plurality of stmts 1038 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fourth plurality of stmts 1038 can be connected at junctions 1062. The proximal ends of adjacent ones of the fourth plurality of struts 1038 can be connected at junctions 1064 (which are also referred to herein as “unions”).

[0259] The fifth plurality of stmts 1040 (which are also referred to herein as a “plurality of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”) can be arranged in a fifth row 1052 that extends in the circumferential direction of the frame 1030 and is proximally disposed relative to the fourth row 1050. Each one of the fifth plurality of stmts 1040 can be oriented at an angle relative to the axial direction of the frame 1030. Each one of the fifth plurality of stmts 1040 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fifth plurality of stmts 1040 can be connected at junctions 1064. The proximal ends of adjacent ones of the fifth plurality of struts 1040 can be connected at junctions 1066 (which are also referred to herein as “unions”).

[0260] The sixth plurality of stmts 1042 (which are also referred to herein as a “plurality of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”) can be arranged in a sixth row 1054 that extends in the circumferential direction of the frame 1030and is proximally disposed relative to the fifth row 1052. Each one of the sixth plurality of struts 1042 can be oriented at an angle relative to the axial direction of the frame 1030. Each one of the sixth plurality of struts 1042 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the sixth plurality of stmts 1042 can be connected at junctions 1066. The proximal ends of adjacent ones of the fifth plurality of stmts 1040 can be connected at curved or rounded proximal apices 1068 that define a proximal end of the proximal valve mounting portion 1028 and / or the frame 1030.

[0261] The stmts of the proximal valve mounting portion 1028 can be arranged and / or connected to form a plurality of cells. For example, the first and second pluralities of stmts 1032, 1034 can connect to each other to form a first circumferentially-extending row of cells 1070. Similarly, the third and fourth pluralities of stmts 1036, 1038 can be connected to each other to form a second row of cells 1072. Similar, the fifth and six pluralities of stmts 1040, 1042 can be connected to each other to form a third row of cells 1074. Although the illustrated proximal valve mounting portion 1028 includes three rows of cells 1070, 1072, 1074, some examples of the proximal valve mounting portion 1028 can include one, two, four, five, six, etc. rows of cells.

[0262] As shown, each cell of the proximal valve mounting portion 1028 has a diamond shape. However, in some examples, the stmts of the proximal valve mounting portion 1028 can be arranged to form cells with different shapes (for example, circles, triangles, other parallelograms, pentagons, hexagons, heptagons, octagons, etc.).

[0263] The intermediate valve positioning portion 1029 can comprise a plurality of axially- extending intermediate connecting stmts 1065 (which are also referred to herein as “intermediate stmts”). As shown, each one of the plurality of axially-extending intermediate connecting stmts 1065 connects a proximal apex 1085p of the distal valve positioning portion 1026 to a corresponding distal apex 1056 of the proximal valve positioning portion 1028.

[0264] FIG. 17 is a flattened view of a frame 1130 of a valve positioning structure, according to one example. A valve positioning stmcture of a delivery apparatus can be formed at least in part by shape setting the frame 1130 in a radially compressed state (for example, the state of the valve positioning stmcture 525 shown in FIG. 10A). The frame 1130 can include a plurality of stmts 1 132 (which are also referred to herein as a “plurality of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”). The plurality of stmts 1032 can be arranged into one or more rows 1144 that extends in a circumferentialdirection of the frame 1130. Within each row 1144, the plurality of struts 1132 can be arranged into a serpentine pattern that extends in the circumferential direction. Each one of the plurality of struts 1 132 can be oriented at an angle relative to an axial direction of the frame 1130. Each one of the plurality of struts 1132 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the plurality of struts 1132 can be connected at curved or rounded apices 1156. The proximal ends of adjacent ones of the plurality of struts 1132 can be connected at curved or rounded apices 1158.

[0265] The frame 1130 can also include a plurality of connecting struts 1163 (which are also referred to herein as a “plurality of axial linear connecting struts,” a “plurality of axial connecting struts,” and / or a “plurality of linear connecting struts”). Each one of the plurality of connecting struts 1163 can extend in the axial direction of the frame 1130. Each one of the plurality of connecting struts 1 163 can connect one of the apices 1156 with an axially adjacent one of the apices 1158. As shown, each one of the plurality of connecting struts 1163 connects every fifth apex 1156 with a corresponding apex 1158 in the circumferential direction. However, the plurality of connecting struts 1163 can be arranged to connect any number of apices 1156, 1158.

[0266] In some examples, the frame 1130 comprises a distal valve positioning portion 1126, a proximal valve positioning portion 1128, and an intermediate valve positioning portion 1129 disposed therebetween. In some examples, a portion of the frame 1130 (for example, the distal valve positioning portion 1126 or the proximal valve positioning portion 1128) can be shape set to form a distal valve positioning structure or a proximal valve positioning structure similar to those shown in FIGS. 5A-5C. In some examples, the distal valve positioning portion 1126 can be axially longer than the proximal valve positioning portion 1128.

[0267] FIG. 18 is a flattened view of a frame 1230 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1230 in a radially compressed state (for example, the state of the valve positioning structure 525 shown in FIG. 10A).

[0268] The frame 1230 can comprise a distal valve positioning portion 1226, the proximal valve positioning portion 1028 proximally disposed relative to the distal valve positioning portion 1226, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1226 and the proximal valve positioning portion 1028. In someexamples, the distal valve positioning portion 1226 can be axially longer than the proximal valve positioning portion 1028.

[0269] The distal valve positioning portion 1226 can include a plurality of struts that includes a first plurality of stmts 1232, a second plurality of stmts 1234, a third plurality of stmts 1236, a fourth plurality of stmts 1238, and a fifth plurality of stmts 1240. The first plurality of stmts 1232 (which are also referred to herein as a “plurality of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”) can be arranged into a first row 1244 that extends in a circumferential direction of the frame 1230. Each one of the first plurality of stmts 1232 can be oriented at an angle relative to an axial direction of the frame 1230. Each one of the first plurality of stmts 1232 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the first plurality of stmts 1232 can be connected at curved or rounded distal apices 1283d that define a distal end of the distal valve positioning portion 1226 and / or the frame 1230. The proximal ends of adjacent ones of the first plurality of stmts 1082 can be connected at curved or rounded apices 1283p.

[0270] The second plurality of stmts 1234 (which are also referred to herein as a “plurality of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”) can be arranged into a second row 1246 that extends in the circumferential direction of the frame 1230. Each one of the second plurality of stmts 1234 can be oriented at an angle relative to the axial direction of the frame 1230. Each one of the second plurality of struts 1234 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the second plurality of stmts 1234 can be connected at curved or rounded apices 1285d. The proximal ends of adjacent ones of the second plurality of stmts 1234 can be connected at curved or rounded apices 1285p.

[0271] The third plurality of stmts 1236 (which are also referred to herein as a “plurality of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”) can be arranged into a third row 1248 that extends in the circumferential direction of the frame 1230. Each one of the third plurality of stmts 1236 can be oriented at an angle relative to the axial direction of the frame 1230. Each one of the third plurality of stmts 1236 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the third plurality of stmts 1236 can be connected at curved or rounded apices 1287d. The proximal ends of adjacent ones of the third plurality of stmts 1236 can be connected at curved or rounded apices 1287p.

[0272] The fourth plurality of struts 1238 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged into a fourth row 1250 that extends in the circumferential direction of the frame 1230. Each one of the fourth plurality of struts 1238 can be oriented at an angle relative to the axial direction of the frame 1230. Each one of the fourth plurality of struts 1238 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fourth plurality of struts 1238 can be connected at curved or rounded apices 1289d. The proximal ends of adjacent ones of the fourth plurality of struts 1238 can be connected at curved or rounded apices 1289p.

[0273] The fifth plurality of struts 1240 (which are also referred to herein as a “plurality of angled linear struts,” a “plurality of angled struts,” and / or a “plurality of linear struts”) can be arranged into a fifth row 1252 that extends in the circumferential direction of the frame 1230. Each one of the fifth plurality of struts 1240 can be oriented at an angle relative to the axial direction of the frame 1230. Each one of the fifth plurality of struts 1240 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fifth plurality of struts 1240 can be connected at curved or rounded apices 129 Id. The proximal ends of adjacent ones of the fifth plurality of struts 1240 can be connected at curved or rounded proximal apices 129 Ip, which can constitute a proximal end of the distal valve positioning portion 1226.

[0274] The distal valve positioning portion 1226 can further include a plurality of connecting stmts 1263 (which are also referred to herein as a “plurality of axial linear connecting stmts,” a “plurality of axial connecting stmts,” and / or a “plurality of linear connecting stmts”). Each one of the plurality of connecting stmts 1263 can extend in an axial direction of the frame 1230 to connect apices of the frame 1230. For example, as shown, connecting stmts 1263 can extend between and connect apices 1283p, 1285p, apices 1285p, 1287p, apices 1287p, 1289p, and apices 1289p, 1291p.

[0275] As shown, each one of the plurality of connecting stmts 1065 of the intermediate valve positioning portion 1029 connects each one of the proximal apices 129 Ip of the distal valve positioning portion 1226 with an axially adjacent one of the distal apices 1056 of the proximal valve positioning portion 1028.

[0276] FIG. 19 is a flattened view of a frame 1330 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at leastin part by shape setting the frame 1330 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A).

[0277] The frame 1330 can comprise a distal valve positioning portion 1326, the proximal valve positioning portion 1028 proximally disposed relative to the distal valve positioning portion 1326, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1326 and the proximal valve positioning portion 1028. In some examples, the distal valve positioning portion 1326 can be axially longer than the proximal valve positioning portion 1028.

[0278] The distal valve positioning portion 1326 can include a plurality of struts that includes a first plurality of struts 1332, a second plurality of stmts 1334, a third plurality of stmts 1336, a fourth plurality of stmts 1338, and a fifth plurality of stmts 1340. The first plurality of stmts 1332 (which are also referred to herein as a “plurality of axial linear stmts,” a “plurality of axial stmts,” and / or a “plurality of linear stmts”) can be arranged into a first row 1344 that extends in a circumferential direction of the frame 1330. Each one of the first plurality of stmts 1332 can be oriented in an axial direction of the frame 1330. Each one of the first plurality of stmts 1332 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the first plurality of stmts 1332 can be connected at curved, rounded, or semicircular distal apices 1383d that define a distal end of the distal valve positioning portion 1326 and / or the frame 1330. The proximal ends of adjacent ones of the first plurality of stmts 1332 can be connected at curved or rounded apices 1383p.

[0279] The second plurality of stmts 1334 (which are also referred to herein as a “plurality of axial linear stmts,” a “plurality of axial stmts,” and / or a “plurality of linear stmts”) can be arranged into a second row 1346 that extends in the circumferential direction of the frame 1330. Each one of the second plurality of stmts 1334 can be oriented in the axial direction of the frame 1330. Each one of the second plurality of stmts 1334 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the second plurality of stmts 1334 can be connected at curved, rounded, or semicircular apices 1385d. The proximal ends of adjacent ones of the second plurality of struts 1334 can be connected at curved, rounded, or semicircular apices 1385p.

[0280] The third plurality of stmts 1336 (which are also referred to herein as a “plurality of axial linear stmts,” a “plurality of axial stmts,” and / or a “plurality of linear stmts”) can be arranged into a third row 1348 that extends in the circumferential direction of the frame 1330.Each one of the third plurality of struts 1336 can be oriented in the axial direction of the frame 1330. Each one of the third plurality of struts 1336 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the third plurality of struts 1336 can be connected at curved, rounded, or semicircular 1387d. The proximal ends of adjacent ones of the third plurality of struts 1336 can be connected at curved, rounded, or semicircular apices 1387p.

[0281] The fourth plurality of struts 1338 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axial stmts,” and / or a “plurality of linear stmts”) can be arranged into a fourth row 1350 that extends in the circumferential direction of the frame 1330. Each one of the fourth plurality of stmts 1338 can be oriented in the axial direction of the frame 1330. Each one of the fourth plurality of stmts 1338 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fourth plurality of stmts 1338 can be connected at curved, rounded, or semicircular apices 1389d. The proximal ends of adjacent ones of the fourth plurality of stmts 1338 can be connected at curved, rounded, or semicircular apices 1389p.

[0282] The fifth plurality of stmts 1340 (which are also referred to herein as a “plurality of axial linear stmts,” a “plurality of axial stmts,” and / or a “plurality of linear stmts”) can be arranged into a fifth row 1352 that extends in the circumferential direction of the frame 1330. Each one of the fifth plurality of struts 1340 can be oriented in the axial direction of the frame 1330. Each one of the fifth plurality of stmts 1340 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the fifth plurality of stmts 1340 can be connected at curved, rounded, or semicircular apices 139 Id. The proximal ends of adjacent ones of the fifth plurality of stmts 1340 can be connected at curved, rounded, or semicircular proximal apices 139 Ip, which can constitute a proximal end of the distal valve positioning portion 1326.

[0283] The distal valve positioning portion 1326 can further include a plurality of connecting stmts 1363 (which are also referred to herein as a “plurality of axial linear connecting stmts,” a “plurality of axial connecting stmts,” and / or a “plurality of linear connecting struts”). Each one of the plurality of connecting stmts 1363 can extend in an axial direction of the frame 1330 to connect apices of the frame 1330. For example, as shown, connecting stmts 1363 can extend between and connect apices 1383p, 1385p, apices 1385p, 1387p, apices 1387p, 1389p, and apices 1389p, 1391p.

[0284] As shown, each one of the plurality of connecting struts 1065 of the intermediate valve positioning portion 1029 connects each one of the proximal apices 139 Ip of the distal valve positioning portion 1326 with an axially adjacent one of the distal apices 1056 of the proximal valve positioning portion 1028.

[0285] FIG. 20A is a side view of a distal end portion of a delivery apparatus 1400, according to one example. The delivery apparatus 1400 includes the intermediate shaft 106, the inner shaft 108, the balloon 118, and the nose cone 122. As shown, the balloon 118 is shown in a deflated state. One exemplary difference between the presently illustrated delivery apparatus 1400 and other delivery apparatuses illustrated herein is that the delivery apparatus 1400 includes a valve positioning structure 1425 disposed around the balloon 118. The valve positioning structure 1425 includes a frame 1430, which is further described with respect to FIG. 20C. The valve positioning structure 1425 is shown in a radially collapsed state.

[0286] FIG. 20B is a side view of the distal end portion of the delivery apparatus 1400, wherein the balloon 118 is in an inflated state and the valve positioning structure 1425 is in a radially expanded state.

[0287] FIG. 20C is a flattened view of the frame 1430 of the valve positioning structure 1425, according to one example. The valve positioning structure 1425 of the delivery apparatus 1400 can be formed at least in part by shape setting the frame 1430 in the radially collapsed state.

[0288] The frame 1430 can comprise a distal valve positioning portion 1426, the proximal valve positioning portion 1028 proximally disposed relative to the distal valve positioning portion 1426, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1426 and the proximal valve positioning portion 1028. In some examples, the distal valve positioning portion 1426 can be axially longer than the proximal valve positioning portion 1428.

[0289] The distal valve positioning portion 1426 can share certain similarities with the distal valve positioning structure 1326 illustrated in FIG. 19. One exemplary difference between the distal valve positioning portion 1426 and the distal valve positioning structure 1326 is that the distal valve positioning portion 1426 includes a plurality of serpentine connecting struts 1463 (which are also referred to herein as a “plurality of connecting struts” and / or a “plurality of connecting s-struts”) instead of the plurality of linear connecting struts 1363. As shown, each one of the plurality of serpentine connecting struts 1463 can include at least onesemicircular turn, such as two semicircular turns as shown. The plurality of serpentine connecting struts 1463 can extend in an axial direction of the frame 1430 to connect apices of the frame 1430. For example, as shown, the serpentine connecting struts 1463 can extend between and connect apices 1383p, 1385p, apices 1385p, 1387p, apices 1387p, 1389p, and apices 1389p, 1391p.

[0290] FIG. 21 is a flattened view of a frame 1530 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1530 in a radially compressed state. For example, the frame 1530 can be formed into either one of a proximal valve positioning structure or a distal valve positioning structure, and optionally can be shape set in the radially collapsed state similar to the valve positioning structures shown in FIG. 5 A and FIG. 5B. In some examples, a valve positioning structure can comprise a first frame 1530 forming a proximal portion of the valve positioning structure, a second frame 1530 forming a distal portion of the valve positioning structure, and an intermediate portion (for example, a plurality of axial struts 536) interconnecting the first and second frames. In some examples, the distal portion of the valve positioning structure can be axially longer than the proximal portion of the valve positioning structure.

[0291] The frame 1530 can comprise a plurality of stmts that includes a first plurality of stmts 1532 (which are also referred to herein as a “plurality of axial linear struts," a “plurality of axial stmts,” and / or a “plurality of linear stmts”) and a second plurality of stmts 1534 (which are also referred to herein as a “plurality of serpentine stmts” and / or a “plurality of s- stmts”). The first plurality of stmts 1532 can be arranged into rows 1544, 1548, 1552, 1556 that each extend in a circumferential direction of the frame 1530. Each one of the first plurality of stmts 1532 can be oriented at an angle relative to an axial direction of the frame 1530. Each one of the first plurality of stmts 1532 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the first plurality of stmts 1532 can be connected at apices 1583d. The proximal ends of adjacent ones of the first plurality of stmts 1532 can be connected at curved or rounded apices 1583p. In some examples, the plurality of struts 1532 can be configured to provide the frame 1530 with structural stiffness and also aid in circumferential expansion of the frame 1530.

[0292] The second plurality of stmts 1534 can be arranged into rows 1546, 1550, 1554 that each extend in the circumferential direction of the frame 1530. Each one of the secondplurality of struts 1534 can be a stmt that forms one or more semicircular turns or curves.For example, as shown, each one of the second plurality of struts 1534 forms four semicircular turns. Each one of the second plurality of struts 1534 can comprise a distal end and a proximal end. The distal end of each one of the second plurality of struts 1534 can be connected to a corresponding one of apices 1583d. The proximal end of each one of the second plurality of struts 1534 can be connected to a corresponding one of apices 1583p.

[0293] In the illustrated example of the frame 1530, rows 1544, 1548, 1552, 1556 of the first plurality of struts 1532 and rows 1546, 1550, 1554 of the second plurality of struts 1534 alternate in the axial direction of the frame 1530. In some examples, alternating rows of the first plurality of struts 1532 and rows of the second plurality of struts 1534 can provide the frame 1530 with desirable mechanical properties. For example, the first plurality of struts 1532 can imbue structural support and / or stiffness to the frame 1530 while the second plurality of struts 1534 (which can more easily elongate in the axial direction than the first plurality of struts 1532) can better allow the frame 1530 to flex and / or elongate. In some examples of the frame 1530, the first plurality of struts 1532 and the second plurality of struts 1534 can be arranged in any number of rows in any configuration (for example, a configuration where the rows of the first plurality of struts 1532 and rows of the second plurality of struts 1534 do not alternate).

[0294] FIG. 22 is a flattened view of a frame 1630 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1630 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10 A). The frame 1630 can comprise a distal valve positioning portion 1626, a proximal valve positioning portion 1628 proximally disposed relative to the distal valve positioning portion 1626, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1626 and the proximal valve positioning portion 1628. As shown, the proximal valve positioning portion 1628 and the distal valve positioning portion 1626 have the same structure. In some examples, the distal valve positioning portion 1626 can be axially longer than the proximal valve positioning portion 1628.

[0295] Each of the distal valve positioning portion 1626 and the proximal valve positioning portion 1628 can comprise a plurality of struts that includes a first plurality of struts 1632 (which are also referred to herein as a “plurality of axial linear struts,” a “plurality of axialstruts,” and / or a “plurality of linear struts”) and a second plurality of stmts 1634 (which are also referred to herein as a “plurality of serpentine stmts,” a “plurality of sinusoidal stmts,” and / or a “plurality of s-stmts”). The first plurality of stmts 1632 can be arranged into rows 1644, 1648, 1652, 1656 that each extend in a circumferential direction of the frame 1630. Each one of the first plurality of stmts 1632 can be oriented at an angle relative to an axial direction of the frame 1630. Each one of the first plurality of stmts 1632 can comprise a distal end and a proximal end. The distal ends of adjacent ones of the first plurality of stmts 1632 can be connected at apices 1683d. The proximal ends of adjacent ones of the first plurality of stmts 1632 can be connected at curved or rounded apices 1683p.

[0296] The second plurality of stmts 1634 can be arranged into rows 1646, 1650, 1654 that each extend in the circumferential direction of the frame 1630. Each one of the second plurality of stmts 1634 can be a stmt that forms one or more curves. For example, as shown, each one of the second plurality of stmts 1634 forms four alternating curves that each extend less than 180 degrees. Each one of the second plurality of stmts 1634 can comprise a distal end and a proximal end. The distal end of each one of the second plurality of stmts 1634 can be connected to a corresponding one of apices 1683d. The proximal end of each one of the second plurality of stmts 1634 can be connected to a corresponding one of apices 1683p. In this way, the second plurality of stmts 1634 (which are capable of a greater degree of elongation than the first plurality of stmts 1632) can better allow the frame 1630 to expand in its axial direction.

[0297] As shown, each one of the plurality of connecting stmts 1065 of the intermediate valve positioning portion 1029 connects each of the proximal -most ones of apices 1683p of the distal valve positioning portion 1626 with a corresponding one of the distal -most apices 1683d of the proximal valve positioning portion 1628.

[0298] FIG. 23 is a flattened view of a frame 1730 of a valve positioning stmcture, according to one example. A valve positioning stmcture of a delivery apparatus can be formed at least in part by shape setting the frame 1730 in a radially compressed state (for example, in the shape of the valve positioning stmcture 525 shown in FIG. 10A). The frame 1730 can comprise a distal valve positioning portion 1726, a proximal valve positioning portion 1728 proximally disposed relative to the distal valve positioning portion 1726, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1726 and the proximal valve positioning portion 1728. As shown, the proximal valve positioningportion 1728 and the distal valve positioning portion 1726 have the same structure. In some examples, the distal valve positioning portion 1726 can be axially longer than the proximal valve positioning portion 1728.

[0299] The valve positioning portions 1726, 1728 can share certain similarities with the valve positioning portions 1626, 1628 illustrated in FIG. 22. One exemplary difference between the valve positioning portions 1726, 1728 and the valve positioning portions 1626, 1628 is that each of the distal valve positioning portion 1726 and the proximal valve positioning portion 1728 can include a second plurality of struts 1734 instead of the second plurality of stmts 1634 illustrated in FIG. 22. As shown, each one of the second plurality of stmts 1734 is a curved or serpentine stmt that forms four alternating semicircular curves or turns. In this way, the second plurality of stmts 1734 (which are capable of a greater degree of elongation than the first plurality of stmts 1632) can better allow the frame 1730 to expand in its axial direction. As shown, the second plurality of stmts 1734 are arranged into circumferentially extending rows 1746, 1750, 1754. As shown, rows 1746, 1750, 1754 are arranged in an alternating pattern with rows 1644, 1648, 1652, 1656.

[0300] FIG. 24A is a side view of a distal end portion of a delivery apparatus 1800, according to one example. The delivery apparatus 1800 includes the intermediate shaft 106, the inner shaft 108, the balloon 118, and the nose cone 122. As shown, the balloon 118 is shown in a deflated state. One exemplary difference between the presently illustrated delivery apparatus 1800 and other delivery apparatuses illustrated herein is that the delivery apparatus 1800 includes a valve positioning stmcture 1825 disposed around the balloon 118. The valve positioning stmcture 1825 includes a frame 1830, which is further described with respect to FIG. 24C.

[0301] FIG. 24B is a side view of the distal end portion of the delivery apparatus 1800, wherein the balloon 118 is in an inflated state and the valve positioning stmcture 1825 in a radially expanded state.

[0302] FIG. 24C is a flattened view of the frame 1830 of the valve positioning stmcture 1825, according to one example. The frame 1830 can comprise a distal valve positioning portion 1826, a proximal valve positioning portion 1828 proximally disposed relative to the distal valve positioning portion 1826, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 1826 and the proximal valve positioning portion 1828. As shown, the proximal valve positioning portion 1828 and thedistal valve positioning portion 1826 have the same structure. In some examples, the distal valve positioning portion 1826 can be axially longer than the proximal valve positioning portion 1828.

[0303] The distal valve positioning portion 1826 (and the proximal valve positioning portion 1828) can share certain similarities with distal valve positioning portion 1626 (and the proximal valve positioning portion 1628) illustrated in FIG. 22 and / or the distal valve positioning portion 1726 (and the proximal valve positioning portion 1728) illustrated in FIG. 23. One exemplary difference is that each of the distal valve positioning portion 1826 and the proximal valve positioning portion 1828 can include a second plurality of struts 1834 instead of the second plurality of struts 1634 illustrated in FIG. 22 or the second plurality of struts 1734 illustrated in FIG. 23. As shown, each one of the second plurality of struts 1834 has a zigzag or sawtooth shape that extends in an axial direction of the frame 1830. In this way, the second plurality of stints 1834, which can elongate to a greater degree than the first plurality of struts 1632, can better allow the frame 1830 to expand in its axial direction. In some examples, the second plurality of struts 1834 can elongate to a greater degree than the second plurality of struts 1634 illustrated in FIG. 22. As shown, the second plurality of struts 1834 are arranged into circumferentially extending rows 1846, 1850, 1854 that alternate with rows 1644, 1648, 1652, 1656 of the first plurality of struts 1632.

[0304] FIG. 25 is a flattened view of a portion of a frame 1930 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 1930 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A). The illustrated portion can be a distal portion (for example, a distal valve positioning portion) or a proximal portion (for example, a proximal valve positioning portion) of the frame 1930.

[0305] One exemplary difference between the frame 1930 and the frame 1830 illustrated in FIG. 24 is that the illustrated portion of the frame 1930 comprises a plurality of struts including the first plurality of stmts 1632, the second plurality of stmts 1834, and a third plurality of struts 1934. As shown, each one of the third plurality of struts 1934 is a linear stmt oriented in an axial direction of the frame 1930.

[0306] As shown, ones of the second plurality of stmts 1834 and ones of the third plurality of stmts 1934 are arranged a pattern of stmts that extend in a circumferential direction of the frame 1930 and form circumferentially -extending rows 1950, 1954. As shown, each row1950. 1954 includes three adjacent ones of the second plurality of struts 1834 that alternate with three adjacent ones of the third plurality of struts 1934. In some examples, this alternating pattern of the second plurality of struts 1834 and the third plurality of struts 1934 can provide the resulting valve positioning structure and / or delivery apparatus with a desirable balance of flexibility and axial strength that better allows the delivery apparatus to navigate the subject's vasculature (for example, the aortic arch).

[0307] FIG. 26 is a flattened view of a frame 2030 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 2030 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A). The frame 2030 can comprise a distal valve positioning portion 2026, a proximal valve positioning portion 2028 proximally disposed relative to the distal valve positioning portion 2026, and an intermediate valve positioning portion 2029 disposed between the distal valve positioning portion 2026 and the proximal valve positioning portion 2028. As shown, the proximal valve positioning portion 2028 and the distal valve positioning portion 2026 have the same structure. In some examples, the distal valve positioning portion 2026 can be axially longer than the proximal valve positioning portion 2028.

[0308] Each one of the valve positioning portions 2026, 2028 includes a plurality of struts that includes the first plurality of struts 1632 and a second plurality of struts 2034. The second plurality of struts are arranged into rows 2046, 2050, 2054. One exemplary difference between the second plurality of struts 2034 and, for example, the second plurality of struts 1634 illustrated in FIG. 22 and / or the second plurality of stmts 1734 illustrated in FIG. 23 is that the second plurality of stmts 2034 are arranged such that a portion of each one of the second plurality of stmts 2034 overlaps a corresponding portion of a circumferentially adjacent one of the second plurality of stmts 2034 when the second plurality of stmts 2034 are arranged into rows 2046, 2050, 2054. In this way, the second plurality of stmts 2034 can provide the frame 2030 with improved strength when the frame 2030 deforms.

[0309] The intermediate valve positioning portion 2029 can include a plurality of connecting stmts 2065 (which are also referred to herein as a “plurality of axial linear connecting stmts,’’ a “plurality of axial connecting stmts,” and / or a “plurality of linear connecting stmts”). One exemplary difference between plurality of connecting stmts 2065 and the plurality of connecting stmts 1065 illustrated, for example, in FIGS. 16, 18-20 and 22-24 is that each oneof the plurality of connecting struts 2065 can have a longer axial length than each one of the plurality of connecting struts 1065.

[0310] FIG. 27 is a flattened view of a frame 2130 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 2130 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A). The frame 2130 can comprise a distal valve positioning portion 2126, a proximal valve positioning portion 2128 proximally disposed relative to the distal valve positioning portion 2126, and the intermediate valve positioning portion 1029 disposed between the distal valve positioning portion 2126 and the proximal valve positioning portion 2128. As shown, the proximal valve positioning portion 2128 and the distal valve positioning portion 2126 have the same structure. In some examples, the distal valve positioning portion 2126 can be axially longer than the proximal valve positioning portion 2128.

[0311] Each one of the distal valve positioning portion 2126 and the proximal valve positioning portion 2128 includes the plurality of struts that includes the first plurality of struts 1632 and the second plurality of struts 2034. One exemplary difference between the valve positioning portions 2126, 2128 and the valve positioning portions 2026, 2028 illustrated in FIG. 26 is that the second plurality of struts 2034 are arranged into circumferentially-extending rows 2146, 2150, 2154, wherein a greater portion of each one of the second plurality of struts 2034 overlaps a corresponding portion of a circumferentially adjacent one of the second plurality of struts as compared to the arrangement shown in FIG. 26. In this way, this greater circumferential density of the second plurality of struts 2034 can provide a more continuous interface for interaction with a sheath, a prosthetic valve, and / or the subject’s anatomy.

[0312] FIG. 28 is a flattened view of a portion of a frame 2230 of a valve positioning structure, according to one example. A valve positioning structure of a delivery apparatus can be formed at least in part by shape setting the frame 2230 in a radially compressed state (for example, in the shape of the valve positioning structure 525 shown in FIG. 10A). In some examples, the illustrated portion of the frame 2230 can be used to form one of a proximal valve positioning structure or a distal valve positioning structure similar to the valve positioning structures shown in FIGS. 5A-5B. The illustrated portion can be a distal portion(for example, a distal valve positioning portion) or a proximal portion (for example, a proximal valve positioning portion) of the frame 2230.

[0313] The illustrated portion of the frame 2230 can include a plurality of struts, including a first plurality of struts 2232, a second plurality of struts 2233, a third plurality of struts 2234, a fourth plurality of struts 2236, a fifth plurality of stmts 2238, a sixth plurality of stmts 2240, and a seventh plurality of stmts 2242. The illustrated portion of the frame 2230 can also include a plurality of axially extending crossbars 2263.

[0314] The first plurality of stmts 2232 (which are also referred to herein as a “plurality of axial linear stmts,” a “plurality of axial stmts,” and / or a “plurality of linear stmts”) can be oriented in an axial direction of the frame 2230. The second plurality of stmts 2233 (which are also referred to herein as a “plurality of circumferential linear stmts,” a “plurality of circumferential stmts,” and / or a “plurality of linear stmts”) can be oriented in the circumferential direction of the frame 2230. Each one of the plurality of axially extending crossbars 2263 can extend in the axial direction to connect axially adjacent ones of the second plurality of stmts 2233. The first and second pluralities of stmts 2232, 2233 and the axial crossbars 2263 can be arranged to form a plurality of cross-shaped or “t”-shaped cells 2270 that extend in a circumferentially-extending row. In some examples, the cross-shaped or “t”-shaped cells 2270 can elongate and / or expand in both the circumferential direction and the axial direction to provide the frame 2230 (or at least a portion thereof) with greater flexibility as compared to frames with other arrangements of stmts.

[0315] The third plurality of stmts 2234 (which are also referred to herein as a “plurality of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”) can be arranged in a circumferentially -extending row 2246 proximally disposed relative the first and second pluralities of stmts 2232, 2233. Each one of the third plurality of stmts 2234 can be oriented at an angle relative to the axial direction of the frame 2230.

[0316] The fourth plurality of stmts 2236 (which are also referred to herein as a “plurality of serpentine stmts,” a “plurality of sinusoidal stmts,” and / or a “plurality of s-stmts”) can be arranged in a circumferentially-extending row 2248 proximally disposed relative to row 2246.

[0317] The fifth plurality of stmts 2238 (which are also referred to herein as a “plurality of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”) can bearranged in a circumferentially-extending row 2250 that is proximally disposed relative to row 2248.

[0318] The sixth plurality of struts 2240 (which are also referred to herein as a “plurality of serpentine stmts,” a “plurality of sinusoidal stmts,” and / or a “plurality of s-struts”) can be arranged in a circumferentially -ext ending row 2252 proximally disposed relative to row 2250.

[0319] The seventh plurality of stmts 2242 (which are also referred to herein as a “plurality of angled linear stmts,” a “plurality of angled stmts,” and / or a “plurality of linear stmts”) can be arranged in a circumferentially-extending row 2254 that is proximally disposed relative to row 2252.

[0320] FIG. 29A is a side view of a distal end portion of a delivery apparatus 2300, according to one example. The delivery apparatus 2300 includes the intermediate shaft 106, the inner shaft 108, the balloon 118, and the nose cone 122. As shown, the balloon 118 is shown in a deflated state. One exemplary difference between the presently illustrated delivery apparatus 2300 and other delivery apparatuses illustrated herein is that the delivery apparatus 2300 includes a valve positioning structure 2325 disposed around the balloon 118. The valve positioning stmcture 2325 includes a frame 2330, which is further described with respect to FIG. 29C.

[0321] When the balloon 118 is in the deflated state and the valve positioning stmcture 2325 is in a radially collapsed state, the valve positioning stmcture 2325 prevents the prosthetic valve 150 from contacting the balloon 1 18. Furthermore, no portion of the valve positioning stmcture 2325 overlaps the outer surface of the prosthetic valve 150.

[0322] FIG. 29B is a side view of the distal end portion of the delivery apparatus 2300, wherein the balloon 118 is in an inflated state and the valve positioning stmcture is in a radially expanded state.

[0323] FIG. 29C is a flattened view of a portion of the frame 2330 of the valve positioning stmcture 2325, according to one example. The illustrated portion can be a distal portion (for example, a distal valve positioning portion) or a proximal portion (for example, a proximal valve positioning portion) of the frame 2330.

[0324] One exemplary difference between the portion of the frame 2330 and the portion of the frame 2230 illustrated in FIG. 28 is that the frame 2330 comprises a first plurality of stmts 2332 (which are also referred to herein as a “plurality of angled linear stmts,” a“plurality of angled struts,’’ and / or a “plurality of linear struts”) instead of the first and second pluralities of struts 2232, 2233. The first plurality of struts 2332 can be arranged in a circumferentially-extending row 2344. The row 2344 can be distally disposed relative to row 2246 of the third plurality of struts 2234. In some examples, the first plurality of struts 2332 and the third plurality of struts 2234 can form a plurality of diamond-shaped cells 2370. In some examples, the plurality of diamond-shaped cells 2370 can keep pleats of a balloon of a resulting delivery apparatus (for example, any one of balloons 118, 218, 318, 418) folded when the balloon is in the deflated state.

[0325] FIG. 30A is a side view of a distal end portion of a delivery apparatus 2400, which is similar to the off-balloon delivery apparatus of FIG. 2B, according to one example. The delivery apparatus 2400 includes the outer shaft 104, the intermediate shaft 106, the inner shaft 108, the balloon 118, the nose cone 122, and an extension tube 119 (which is also referred to herein as a “crimp balloon”) that extends from the intermediate shaft 106 to the balloon 118 over the inner shaft 108. The extension tube 119 can have a distal end portion connected (for example, bonded) to a proximal leg of the balloon 118 and a proximal end portion connected (for example, bonded) to a distal end portion of the intermediate shaft 106. The extension tube 119, in some examples, can comprise a thin, flexible material, such as the material used to form the balloon 118. The extension tube 119 can be referred to as a “crimp balloon” because the prosthetic valve 150 can be crimped at a location along the length of the crimp balloon 119 prior to insertion into the subject’s body. In some examples, the extension tube 119 is not included and the distal end portion of the intermediate shaft 106 can extend to the proximal leg of the balloon 118, where it is connected to the balloon 118.

[0326] As further shown in FIG. 30B, the delivery apparatus 2400 includes the valve positioning structure 1825 coupled to the outer shaft 104. FIG. 30B shows the delivery apparatus 2400 during a first stage of a prosthetic valve delivery procedure. A proximal end portion of the proximal valve positioning portion 1828 can be connected to a distal end portion of the outer shaft 104. The valve positioning structure 1825 is shown connected to an inner surface of the outer shaft 104. However, in some examples, the valve positioning structure 1825 can be connected to an outer surface of the outer shaft 104. The valve positioning structure 1825 can be coupled to the outer shaft 104 using mechanical fasteners, adhesives, press-fits, ultrasonic welds, reflowing the shaft 104 on the valve positioning structure 1825, etc. In some examples, the valve positioning structure 1825 can be fixedlyconnected to the outer shaft 104. Since the outer shaft 104 and the intermediate shaft 106 are translatable longitudinally relative to each other, the valve positioning structure 1825 is not fixed to the intermediate shaft 106 or to the balloon 118, and therefore the valve positioning structure 1825 can be displaced in the axial direction relative to the intermediate shaft 106, the balloon 118, the extension tube 119, and the inner shaft 108. Although the delivery apparatus 2400 is shown with the valve positioning structure 1825, it should be understood that the delivery apparatus 2400 can include any valve positioning structure disclosed herein.

[0327] The valve positioning structure 1825 is shown in an “off-balloon” position where the intermediate portion 1029 of the valve positioning structure 1825 is spaced apart or offset in an axial direction of the delivery apparatus 2400 from the valve mounting portion 124 of the balloon 118. In other words, the intermediate portion 1029 of the valve positioning structure 1825 in the off-balloon position does not overlap the valve mounting portion 124 of the balloon 118. In some examples, the valve positioning structure 1825 can extend over the extension tube 119 and no portion of the valve positioning structure 1825 overlaps any portion of the balloon 118. In some examples, although the intermediate portion 1029 of the valve positioning structure 1825 does not overlap the valve mounting portion 124 of the balloon 118, the valve positioning structure 1825 or a portion thereof (for example, the distal valve positioning portion 1826) can partially overlap a proximal end portion of the balloon 118. As shown, the valve positioning structure 1825 is radially collapsed when it is in the off-balloon position.

[0328] In some examples, the delivery apparatus 2400 can be “de-aired” prior to the stage shown in FIG. 30B. De-airing the delivery apparatus 2400 can include flushing the radial gap between the outer shaft 104 and the intermediate shaft 106, which is coaxially disposed within the outer shaft 104, with a saline solution to evacuate any air bubbles present within the radial gap.

[0329] FIG. 30C is a side view of the distal end portion of the delivery apparatus 2400 during a second stage of the prosthetic valve delivery procedure. During this stage, the prosthetic valve 150 (or any other prosthetic valve disclosed herein, such as prosthetic valve 10) can be crimped around the intermediate portion 1029 of the radially collapsed valve positioning structure 1825 in the off-balloon position. Thus, the procedure illustrated in FIGS. 30B-30E can be referred to as an “off-balloon procedure” or an “off-balloon crimping procedure.” The radially collapsed prosthetic valve 150 can define an outer diameter 150d (which is alsoreferred to as a “crimped diameter’’ or a “compressed diameter’’) after it is crimped around the valve positioning structure 1825. In some examples, the outer diameter 150d of the crimped prosthetic valve 150 can be less than 8 millimeters, less than 7.5 millimeters, or less than 7 millimeters.

[0330] In some examples, crimping the prosthetic valve 150 around the valve positioning structure 1825 in the off-balloon position can result in the prosthetic valve 150 having a narrower crimped profile and a smaller crimped diameter 150d. The intermediate portion 1029 of the valve positioning structure 1825 can be further crimped, collapsed, or compressed if it only overlaps the extension tube 119, compared to crimping the prosthetic valve when the intermediate portion 1029 is in a position overlapping the balloon 118. Thus, the prosthetic valve 150 can be further crimped, collapsed or compressed around the relatively narrower intermediate portion 1029. Reducing the crimped profile and the crimped diameter 150d of the prosthetic valve 150 can beneficially make it easier to advance the prosthetic valve 150 through a subject’s vasculature to a target implantation site.

[0331] In some examples, the prosthetic valve delivery procedure can further include, after crimping the prosthetic valve 150 around the valve positioning structure 1825, measuring the crimped diameter 150d. In this way, a user of the delivery apparatus 2400 can ensure the that prosthetic valve 150 is crimped to a sufficient degree.

[0332] FIG. 30D is a side view of the distal end portion of the delivery apparatus 2400 during a third stage of the prosthetic valve delivery procedure. During this stage, the valve positioning structure 1825 can be moved in an axial direction to an “on-balloon” position that is spaced apart in the axial direction from the off-balloon position. In the on-balloon position, the intermediate portion 1029 of the valve positioning structure 1825 and the prosthetic valve 150 crimped therearound overlap the valve mounting portion 124 of the balloon 118. Thus, the intermediate portion 1029 of the valve positioning structure 1825 can be aligned in the axial direction with the valve mounting portion 124. As shown, the valve positioning structure 1825 is moved in the distal direction to the on-balloon position.However, in some examples where the off-balloon position is distally disposed relative to the balloon 118, the valve positioning structure 1825 can be moved in a proximal direction to the on-balloon position.

[0333] Since the valve positioning structure 1825 is connected to the outer shaft 104, the balloon 118 is connected via the extension tube 119 to the intermediate shaft 106, and theouter shaft 104 and the intermediate shaft 106 can translate relative to each other, the valve positioning structure 1825 (for example, the intermediate valve mounting portion 1029) can be aligned with the balloon 118 (for example, the valve mounting portion 124 of the balloon 118) by moving the outer shaft 104 in the axial direction (for example, the distal direction) relative to the intermediate shaft 106, the extension tube 119, the balloon 118, and the inner shaft 108. In some examples, the delivery apparatus 2400 can include the adjustment mechanism 161 configured to adjust the axial position of the intermediate shaft 106 relative to the outer shaft 104. In such examples, a user of the delivery apparatus 2400 can actuate the adjustment mechanism 161 to align the valve positioning structure 1825 with the balloon 118.

[0334] The stage of the prosthetic valve delivery procedure shown in FIG. 30D can be performed at any time after the distal end of the delivery apparatus 2400 has been introduced into the subject’s vasculature. For example, if the prosthetic valve 150 is to be implanted within the subject’s native aortic annulus, the valve positioning structure 1825 can be aligned with the balloon 118 within any one of the subject’s descending aorta, aortic arch, or ascending aorta.

[0335] FIG. 30E is a side view of the distal end portion of the delivery apparatus 2400 during a fourth stage of the prosthetic valve delivery procedure, after the prosthetic valve 150 has been advanced to and positioned within the implantation site (for example, the native aortic valve). During this stage, the balloon 118 is expanded from the deflated state to an inflated state. The inflation of the balloon 118 is effective to expand the valve positioning structure 1825 to the radially expanded state and also expand the prosthetic valve 150 to the radially expanded state. After the prosthetic valve 150 is deployed, the balloon 118 can be deflated and the valve positioning structure 1825 can return to its radially collapsed state, as previously described.

[0336] In some examples, the prosthetic valve 150 can be rotationally aligned with a specific anatomical landmark of the subject’s anatomy. For example, when implanting the prosthetic valve 150 within the native aortic valve, it can be desirable to align the commissures 22 of the prosthetic valve 150 with the native commissures. Thus, prior to deploying (expanding) the prosthetic valve 150, the prosthetic valve 150 can be rotated until the commissures 22 are aligned with the native valve. This can be accomplished by rotating the handle 102 of the delivery apparatus 2400, which is effective to transmit torque to the outer shaft 104 and thevalve positioning structure 1825, thereby rotating the prosthetic valve 150. Various imaging techniques and procedures for rotationally aligning the commissures of a prosthetic valve with the commissures of a native aortic valve are disclosed in WIPO Publication No. 2022 / 046585, which is incorporated by reference herein. In some examples, the prosthetic valve 150 can include radiopaque markers to assist in aligning the prosthetic valve with the native commissures. In some examples, the valve positioning structure 1825 (or any other valve positioning structure disclosed herein) can include radiopaque markers (distinguishable from the struts of the valve positioning structure) to assist in aligning the prosthetic valve with the native commissures.

[0337] In some examples, the valve positioning structure 1825 can be moved from the on- balloon position back to the off-balloon position after the prosthetic valve 150 has been radially expanded and deployed, the balloon 118 has been deflated, and the valve positioning structure 1825 has been collapsed. In some examples, moving the valve positioning structure 1825 to the off-balloon position before the distal end portion of the delivery apparatus 2400 is retracted can help minimize the crimped profile of the valve positioning structure 1825, which can help facilitate the retraction of the delivery apparatus 2400 back through the introducer sheath and out of the subject’s vasculature.

[0338] FIG. 31 is a flowchart 2500 of an off-balloon delivery procedure, according to an example. During the off-balloon delivery procedure, a delivery apparatus (for example, delivery apparatus 2400) can be used to introduce a prosthetic valve (for example, prosthetic valve 150) into a subject’s vasculature, advance the prosthetic valve a target implantation site, and expand the prosthetic valve to a radially expanded state. In some examples, the delivery apparatus 2400, which includes the valve positioning structure 1825 movable between an on-balloon position and an off-balloon position, can be used to perform the method embodied by the flowchart 2500. Although the following description of the flowchart 2500 may refer to certain features of the delivery apparatus 2400, it should be understood that any suitable delivery apparatus configured for off-balloon delivery can be used to perform the method embodied by the flowchart 2500. It should further be understood that the method embodied by the flowchart 2500 can be used to implant any suitable prosthetic heart valve (for example, any one of prosthetic valves 10, 150). It should further be understood that although the description of this method primarily is made with reference to prosthetic valves, the off-balloon delivery method embodied by the flowchart 2500 can beused to implant any suitable medical device (for example, stents, grafts, embolic coils) in a subject.

[0339] In some examples, the method can optionally include, at block 2510, de-airing the delivery apparatus. As previously discussed above, de-airing the delivery apparatus can include flushing a radial gap between an outer shaft (for example, outer shaft 104) and an intermediate shaft (for example, intermediate shaft 106) of the delivery apparatus with a saline solution to evacuate any air bubbles present within the radial gap. The intermediate shaft can be coaxially disposed within the outer shaft. In some examples, de-airing the delivery apparatus can further reduce the chance of an air embolism occurring during the off- balloon delivery procedure.

[0340] In some examples, such as where the delivery apparatus is assembled and / or packaged such that the radial gap comes pre-filled with the saline solution, the optional step at block 2510 can be omitted.

[0341] At block 2520, the prosthetic valve can be crimped around an intermediate portion (for example, intermediate portion 1029) of a radially collapsed valve positioning structure in an off-balloon position. As previously discussed, the off-balloon position is a position in which the intermediate portion of the valve positioning structure is not axially aligned with a valve mounting portion (for example, the valve mounting portion 124) of a balloon (for example, the balloon 118) of the delivery apparatus (for example, the intermediate portion of the valve positioning structure does not overlap the valve mounting portion of the balloon). In some examples, a crimping device can be used to crimp the prosthetic valve around the valve positioning structure in the off-balloon position.

[0342] In some examples, the off-balloon delivery procedure can optionally include moving the valve positioning structure to the off-balloon position (for example, from an on-balloon position) prior to crimping the prosthetic valve around the valve positioning structure. However, in examples where the delivery apparatus is assembled and / or packaged such that the valve positioning structure is packaged in the off-balloon position, the optional step of moving the valve positioning structure to the off-balloon position can be omitted.

[0343] At block 2530, a crimped diameter (for example, crimped diameter 150d) of the prosthetic valve can optionally be measured. In some examples, measuring the crimped diameter of the prosthetic valve before it is introduced into a subject’s vasculature can help ensure the that prosthetic valve is crimped to a sufficient degree. However, in someexamples, such as where the crimped diameter is known and / or below a certain threshold, the optional step of measuring the crimped diameter can be omitted.

[0344] At block 2540, a distal end portion of the delivery apparatus — including the valve positioning structure in the off-balloon position — and the prosthetic valve mounted to the distal end of the delivery apparatus can be introduced into a subject’s vasculature. In some examples, the distal end of the delivery apparatus and the prosthetic valve mounted thereto can be inserted through an introducer sheath and into the subject’s vasculature. The delivery apparatus and the prosthetic valve can be introduced into the subject’s vasculature at any suitable location (for example, a femoral artery, a femoral vein, a subclavian artery, an axillary artery, a carotid artery, a surgical incision in the chest, etc.), including any location described with respect to any one of the various delivery techniques disclosed herein.

[0345] The distal end portion of the delivery apparatus and the prosthetic valve can subsequently be advanced through the subject’s vasculature toward a target implantation site (for example, any one of the native aortic, pulmonary, mitral, and tricuspid valves). The target implantation site can be any site described with respect to any one of the various delivery techniques disclosed herein. As previously discussed, crimping the prosthetic valve around the valve positioning structure in the off-balloon position can result in the prosthetic valve having a narrower crimped profile and / or a smaller crimped diameter, which can beneficially make it easier to introduce the prosthetic valve into the subject’s vasculature and / or advance the prosthetic valve through the subject’s vasculature toward a target implantation site.

[0346] At block 2550, the valve positioning structure can be moved from the off-balloon position to an on-balloon position. As previously described, the on-balloon position is a position where the intermediate portion of the valve positioning structure and the prosthetic valve crimped therearound overlap the valve mounting portion of the balloon. In some examples, the valve positioning structure can be moved to the on-balloon position after the distal end portion of the delivery apparatus reaches the target implantation site. In some examples, the valve positioning structure can be moved to the on-balloon position after the distal end portion of the delivery apparatus is introduced into the subject’s vasculature but before the distal end portion of the delivery apparatus reaches the target implantation site, such as within the ascending or descending aorta.

[0347] In some examples, at block 2560, the prosthetic valve can optionally be rotationally aligned with an anatomical landmark of the subject’s vasculature (for example, one or more native commissures of a target native valve). In some examples, the prosthetic valve can be rotated by rotating a handle (for example, handle 102) of the delivery apparatus, which is effective to transmit torque to the outer shaft and the valve positioning structure, thereby rotating the prosthetic valve.

[0348] In some examples, various imaging techniques and procedures can be used to align the commissures of the prosthetic valve with the commissures of the target native valve. Example imaging techniques are disclosed in WIPO Publication No. 2022 / 046585, which is incorporated by reference above. In some examples where the prosthetic valve, the valve positioning structure, and / or the distal end of the delivery apparatus include at least one radiopaque marker, rotationally aligning the prosthetic valve can include aligning the at least one radiopaque marker with the anatomical landmark.

[0349] At block 2570, once the prosthetic valve has reached the target implantation site (for example, within a native valve annulus), the balloon can be inflated to deploy the prosthetic valve to a radially expanded working state.

[0350] In some examples, the valve positioning structure can be moved to the on-balloon position by actuating an adjustment mechanism (for example, adjustment mechanism 161) disposed at a proximal end portion (for example, the handle) of the delivery apparatus.

[0351] In some examples, at block 2580, after deflating the balloon, the distal end portion of the delivery apparatus can be retracted through and removed from the subject’s vasculature. In some examples, the valve positioning structure can be moved from the on-balloon position back to the off-balloon position after the prosthetic valve has been deployed, after the balloon has been deflated, and / or after the valve positioning structure has been collapsed but before the distal end portion of the delivery apparatus has been retracted through the subject’s vasculature. As previously discussed, moving the valve positioning structure to the off- balloon position before the distal end portion of the delivery apparatus has been retracted can help minimize the crimped profile of the valve positioning structure, which can help facilitate the retraction of the delivery apparatus out of the subject’s vasculature.

[0352] In some examples, the delivery method illustrated by the flowchart 2500 can additionally or alternatively include one or more stages of any other delivery technique disclosed herein.THVDL-23563 WOOl

[0353] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation usable and / or for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals usable and / or for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.Delivery Techniques

[0354] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (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-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve. Alternatively, a prosthetic valve can be delivered to the native aortic valve via a subclavian artery, an axillary artery, a carotid artery, or via a transcaval delivery procedure.

[0355] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion ofTHVDL-23563 WOOl the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. 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.

[0356] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0357] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0358] 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.

[0359] The techniques, methods, processes, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g.,human, other animal, etc.) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.Additional Examples of the Disclosed Technology

[0360] 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.

[0361] Example 1. A delivery system for delivering a prosthetic valve through vasculature of a subject can comprise: a handle, a shaft, a balloon, and a valve positioning structure. The shaft can be coupled to the handle. The balloon can be coupled to a distal end portion of the shaft. The balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state. The balloon can include a valve mounting portion for mounting the prosthetic valve in a radially compressed state. The valve positioning structure can extend at least partially over an exterior surface of the balloon and can have a first end portion and a second end portion. The valve positioning stmcture can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then resiliently radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0362] Example 2. The delivery system of any example herein, particularly Example 1, wherein the valve positioning stmcture can comprise a frame constructed of a shape-memory material, wherein the frame can be shape set in the radially collapsed configuration.

[0363] Example 3. The delivery system of any example herein, particularly Example 2, wherein the shape-memory material can be Nitinol.

[0364] Example 4. The delivery system of any example herein, particularly any one of Examples 1-3, wherein the valve positioning stmcture can extend around the exterior surface of the balloon at the first end portion.

[0365] Example 5. The delivery system of any example herein, particularly Example 4, wherein the first end portion can be a distal end portion of the balloon.

[0366] Example 6. The delivery system of any example herein, particularly Example 4, wherein the first end portion can be a proximal end portion of the balloon.

[0367] Example 7. The delivery system of any example herein, particularly Example 4, wherein the valve positioning structure can extend around the exterior surface of the balloon at both the first end portion and the second end portion of the balloon.

[0368] Example 8. The delivery system of any example herein, particularly any one of Examples 1-7, wherein the valve positioning structure can comprise a proximal valve positioning portion, a distal valve positioning portion, and an intermediate valve positioning portion disposed between the proximal and distal valve positioning portions.

[0369] Example 9. The delivery system of any example herein, particularly Example 8, wherein the proximal valve positioning portion of the valve positioning structure can be coupled to the shaft.

[0370] Example 10. The delivery system of any example herein, particularly Example 8, wherein the proximal valve positioning portion can be coupled to an inner surface of the shaft.

[0371] Example 11. The delivery system of any example herein, particularly Example 8, wherein the proximal valve positioning portion can be coupled to an outer surface of the shaft.

[0372] Example 12. The delivery system of any example herein, particularly Example 8, wherein the delivery system can further comprise a nose cone distally disposed relative to the balloon, and wherein distal valve positioning portion of the valve positioning structure can be coupled to the nose cone.

[0373] Example 13. The delivery system of any example herein, particularly any one of Examples 8-12, wherein the intermediate valve positioning portion can be configured to receive the prosthetic valve.

[0374] Example 14. The delivery system of any example herein, particularly any one of Examples 8-13, wherein the distal valve positioning portion can have an outer diameter that is greater than an outer diameter of the intermediate valve positioning portion.

[0375] Example 15. The delivery system of any example herein, particularly any one of Examples 8-14, wherein the proximal valve positioning portion can have an outer diameter that is greater than an outer diameter of the intermediate valve positioning portion.

[0376] Example 16. The delivery system of any example herein, particularly any one of Examples 8-15, wherein the distal valve positioning portion can taper in diameter in a direction from the intermediate valve positioning portion to a distal end of the valve positioning structure.

[0377] Example 17. The delivery system of any example herein, particularly any one of Examples 8-16, wherein the proximal valve positioning portion can taper in diameter in a direction from the intermediate valve positioning portion to a proximal end of the valve positioning structure.

[0378] Example 18. The delivery system of any example herein, particularly any one of Examples 8-17, wherein the distal valve positioning portion can have a frustoconical shape.

[0379] Example 19. The delivery system of any example herein, particularly any one of Examples 8-18, wherein the proximal valve positioning portion can have a frustoconical shape.

[0380] Example 20. The delivery system of any example herein, particularly any one of Examples 8-19, wherein the distal valve positioning portion can comprise a plurality of struts.

[0381] Example 21. The delivery system of any example herein, particularly Example 20, wherein the plurality of struts can include a first plurality of struts arranged in a first row that extends in a circumferential direction of the delivery system and a second plurality of stmts arranged in a second row that extends in the circumferential direction.

[0382] Example 22. The delivery system of any example herein, particularly Example 21, wherein each one of the first plurality of stmts can be a linear stmt oriented at an angle relative to an axial direction of the delivery system.

[0383] Example 23. The delivery system of any example herein, particularly Example 22, wherein each one of the first plurality of stmts can be a linear stmt oriented in an axial direction of the delivery system.

[0384] Example 24. The delivery system of any example herein, particularly any one of Examples 21 -23, wherein each one of the second plurality of stmts can be a serpentine stmt.

[0385] Example 25. The delivery system of any example herein, particularly Example 24, wherein the serpentine stmt can form a plurality of semicircular turns.

[0386] Example 26. The delivery system of any example herein, particularly Example 24, wherein the serpentine strut can form a plurality of curves that each extend less than 180 degrees.

[0387] Example 27. The delivery system of any example herein, particularly any one of Examples 21-26, wherein each one of the second plurality of struts can be a zigzag strut.

[0388] Example 28. The delivery system of any example herein, particularly any one of Examples 8-27, wherein the proximal valve positioning portion can comprise a plurality of struts.

[0389] Example 29. The delivery system of any example herein, particularly Example 28, wherein the plurality of struts can include a first plurality of struts arranged in a first row that can extend in a circumferential direction of the delivery system and a second plurality of struts that can be arranged in a second row that can extend in the circumferential direction.

[0390] Example 30. The delivery system of any example herein, particularly Example 29, wherein each one of the first plurality of struts can be a linear strut oriented at an angle relative to an axial direction of the delivery system.

[0391] Example 31. The delivery system of any example herein, particularly any one of Examples 29-30, wherein each one of the second plurality of stmts can be a serpentine stmt.

[0392] Example 32. The delivery system of any example herein, particularly Example 31, wherein the serpentine stmt can form a plurality of semicircular turns.

[0393] Example 33. The delivery system of any example herein, particularly Example 31 , wherein the serpentine stmt can form a plurality of curves that each extend less than 180 degrees.

[0394] Example 34. The delivery system of any example herein, particularly any one of Examples 29-30, wherein each one of the second plurality of stmts can be a zigzag stmt.

[0395] Example 35. The delivery system of any example herein, particularly any one of Examples 8-34, wherein the intermediate valve positioning portion can comprise a plurality of axial connecting stmts that connect the distal valve positioning portion and the proximal valve positioning portion.

[0396] Example 36. The delivery system of any example herein, particularly any one of Examples 1-35, wherein the balloon can have an axial length in a range from 45 mm to 51 mm.

[0397] Example 37. The delivery system of any example herein, particularly Example 36, wherein the balloon can have an axial length in a range from 46 mm to 50 mm.

[0398] Example 38. The delivery system of any example herein, particularly any one of Examples 1-35, wherein the balloon can have an axial length in a range from 31 mm to 45 mm.

[0399] Example 39. The delivery system of any example herein, particularly Example 38, wherein the balloon can have an axial length in a range from 31 mm to 36 mm.

[0400] Example 40. The delivery system of any example herein, particularly any one of Examples 1-35, wherein the balloon can have an axial length in a range from 25 mm to 31 mm.

[0401] Example 41. The delivery system of any example herein, particularly Example 40, wherein the balloon can have an axial length in a range from 26 mm to 30 mm.

[0402] Example 42. The delivery system of any example herein, particularly any one of Examples 1-19, wherein the frame can comprise a braided mesh structure.

[0403] Example 43. The delivery system of any example herein, particularly any one of Examples 1-42, wherein the valve positioning structure can prevent the prosthetic valve from contacting the balloon.

[0404] Example 44. The delivery system of any example herein, particularly any one of Examples 1-43, wherein the valve positioning structure can be configured such that it does not overlap an outer surface of the prosthetic valve.

[0405] Example 45. The delivery system of any example herein, particularly any one of Examples 1-44, wherein the valve positioning structure can comprise a polymeric coating attached to the frame.

[0406] Example 46. The delivery system of any example herein, particularly Example 45, wherein the polymeric coating can be disposed on an inner surface of the frame.

[0407] Example 47. The delivery system of any example herein, particularly Example 45, wherein the polymeric coating can be disposed on an outer surface of the frame.

[0408] Example 48. The delivery system of any example herein, particularly Example 45, wherein the polymeric coating can encapsulate the frame.

[0409] Example 49. The delivery system of any example herein, particularly any one of Examples 1-48, wherein the valve positioning structure can be not attached to the exterior surface of the balloon.

[0410] Example 50. The delivery system of any example herein, particularly any one of Examples 1-49, which can further comprise the prosthetic valve, wherein the prosthetic valve can be mounted over the valve mounting portion of the balloon.

[0411] Example 51. A delivery apparatus for delivering a prosthetic valve through vasculature of a subject can comprise: a handle, a balloon catheter, and a first valve positioning structure. The balloon catheter can comprise a shaft coupled to the handle and a balloon connected to a distal end portion of the shaft. The balloon can be configured to be inflated from an uninflated state to an inflated state. The first valve positioning structure can extend over an exterior surface of the balloon. The first valve positioning structure can comprise a first frame constructed of a shape-memory material. The first frame can be shape set in a radially compressed configuration.

[0412] Example 52. The delivery apparatus of any example herein, particularly Example51, can further comprise a second valve positioning structure extending over the exterior surface of the balloon, wherein: the second valve positioning structure can comprise a second frame constructed of the shape-memory material, the second frame can be shape set in a radially compressed configuration, and the first valve positioning structure and the second valve positioning structure can be configured to expand to a radially expanded state when the balloon is in the inflated state.

[0413] Example 53. The delivery apparatus of any example herein, particularly Example52, wherein each one of the first frame and the second frame can comprise a plurality of interconnected struts defining a plurality of cells.

[0414] Example 54. The delivery apparatus of any example herein, particularly any one of Examples 52-53, wherein the first valve positioning structure and the second valve positioning structure can be spaced apart in an axial direction of the delivery apparatus and can define a valve mounting portion of the delivery apparatus configured to receive the prosthetic valve.

[0415] Example 55. The delivery apparatus of any example herein, particularly Example 54, wherein the first valve positioning structure can be distally disposed relative to the second valve positioning structure.

[0416] Example 56. The delivery apparatus of any example herein, particularly any one of Examples 54-55, which can further comprise the prosthetic valve, wherein the prosthetic valve can be mounted over a valve mounting portion of the balloon.

[0417] Example 57. The delivery apparatus of any example herein, particularly Example 56, wherein neither the first valve positioning structure nor the second valve positioning structure can extend over an outer surface of the prosthetic valve when the prosthetic valve is mounted over the valve mounting portion.

[0418] Example 58. The delivery apparatus of any example herein, particularly any one of Examples 56-57, wherein the valve mounting portion can be disposed between the first and second valve positioning structures.

[0419] Example 59. The delivery apparatus of any example herein, particularly any one of Examples 56-58, wherein an outer diameter of the first valve positioning structure in the radially compressed configuration can be greater than an outer diameter of the prosthetic valve in a radially compressed configuration.

[0420] Example 60. The delivery apparatus of any example herein, particularly Example 59, wherein an outer diameter of the second valve positioning structure in the radially compressed configuration can be greater than an outer diameter of the prosthetic valve in the radially compressed configuration.

[0421] Example 61. The delivery apparatus of any example herein, particularly any one of Examples 51-60, wherein the first valve positioning structure can comprise a distal end and a proximal end, wherein an outer diameter of the first valve positioning structure at the distal end can be smaller than an outer diameter of the first valve positioning structure at a location between the distal end and the proximal end when the first valve positioning structure is in the radially compressed configuration.

[0422] Example 62. The delivery apparatus of any example herein, particularly any one of Examples 52-61, wherein at least one of the first valve positioning structure and the second valve positioning structure can comprise Nitinol.

[0423] Example 63. The delivery apparatus of any example herein, particularly any one of Examples 51-62, which can further comprise at least one tether connected to the first valve positioning structure.

[0424] Example 64. A delivery system for delivering a prosthetic valve through vasculature of a subject can comprise: a radially expandable prosthetic valve and a delivery apparatus.The delivery apparatus can comprise: a handle, a shaft, an expandable distal valve positioning structure, and a an expandable proximal valve positioning structure. The shaft can be coupled to the handle and a balloon coupled to a distal end portion of the shaft. The balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state. The prosthetic valve can be mounted on the balloon in a radially compressed state. The expandable distal valve positioning structure can be disposed on an exterior surface of a distal end portion of the balloon. The expandable proximal valve positioning structure can be disposed on an exterior surface of a proximal end portion of the balloon. The distal and proximal valve positioning structures can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0425] Example 65. The delivery system of any example herein, particularly Example 64, wherein the delivery apparatus can further comprise at least one tether connected to the distal valve positioning structure.

[0426] Example 66. The delivery system of any example herein, particularly Example 65, wherein the at least one tether can be configured to cause the distal valve positioning structure to further radially collapse when the distal valve positioning structure is in the radially collapsed state and tension is increased in the tether.

[0427] Example 67. The delivery apparatus of any example herein, particularly any one of Examples 65-66, wherein an intermediate portion of the at least one tether can be looped around a portion of the distal valve positioning structure.

[0428] Example 68. The delivery apparatus of any example herein, particularly any one of Examples 65-66, wherein the at least one tether can include a distal end portion that terminates in a loop secured to portion of the distal valve positioning structure.

[0429] Example 69. The delivery apparatus of any example herein, particularly any one of Examples 65-68, wherein the at least one tether can extend through a lumen of the shaft and along an outer surface of the balloon.

[0430] Example 70. A delivery system for delivering a prosthetic valve through vasculature of a subject can comprise: a radially expandable prosthetic valve and a delivery apparatus. The delivery apparatus can comprise: a handle, a shaft, and an expandable valve positioning structure. The shaft can be coupled to the handle and a balloon coupled to a distal endportion of the shaft. The balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state. The prosthetic valve can be mounted on the balloon in a radially compressed state. The expandable valve positioning structure can be disposed on an exterior surface of a portion of the balloon. The valve positioning structure can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then resiliently radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0431] Example 71. The delivery system of any example herein, particularly Example 70, wherein the valve positioning structure can be constructed of a shape-memory material.

[0432] Example 72. The delivery system of any example herein, particularly Example 71, wherein the valve positioning structure can be shape set into the radially collapsed state.

[0433] Example 73. The delivery system of any example herein, particularly any one of Examples 70-72, wherein the expandable valve positioning structure can comprise a frame that includes a distal valve positioning portion, a proximal valve positioning portion, and an intermediate valve positioning portion disposed between the distal valve positioning portion and the proximal valve positioning portion.

[0434] Example 74. The delivery system of any example herein, particularly Example 73, wherein each of the distal valve positioning portion and the proximal valve positioning portion can have an outer diameter, and wherein each of the outer diameters of the distal valve positioning portion and the proximal valve positioning portion are greater than an outer diameter of the intermediate valve positioning portion when the valve positioning structure is in the radially collapsed state.

[0435] Example 75. The delivery system of any example herein, particularly any one of Examples 73-74, wherein each of the distal valve positioning portion and the proximal valve positioning portion can have an outer diameter, and wherein each of the outer diameters of the distal valve positioning portion and the proximal valve positioning portion can be greater than an outer diameter of the intermediate valve positioning portion when the valve positioning structure is in a partially radially expanded state between the radially collapsed state and the radially expanded state.

[0436] Example 76. The delivery system of any example herein, particularly any one of Examples 73-75, wherein each of the distal valve positioning portion, the proximal valve positioning portion, and the intermediate valve positioning portion can have an outerdiameter, and wherein the outer diameters can be equal when the valve positioning structure is in the radially expanded state.

[0437] Example 77. The delivery system of any example herein, particularly any one of Examples 73-76, wherein the distal valve positioning portion can comprise a plurality of struts.

[0438] Example 78. The delivery system of any example herein, particularly Example 77, wherein the plurality of struts can include a first plurality of struts arranged in a first row that can extend in a circumferential direction of the delivery system and a second plurality of struts arranged in a second row that can extend in the circumferential direction.

[0439] Example 79. The delivery system of any example herein, particularly Example 78, wherein each one of the first plurality of struts can be a linear strut oriented at an angle relative to an axial direction of the delivery system.

[0440] Example 80. The delivery system of any example herein, particularly Example 78, wherein each one of the first plurality of struts can be a linear strut oriented in an axial direction of the delivery system.

[0441] Example 81. The delivery system of any example herein, particularly any one of Examples 78-80, wherein each one of the second plurality of stmts can be a serpentine stmt.

[0442] Example 82. The delivery system of any example herein, particularly Example 81, wherein the serpentine stmt can form a plurality of semicircular turns.

[0443] Example 83. The delivery system of any example herein, particularly Example 81, wherein the serpentine stmt can form a plurality of curves that each extend less than 180 degrees.

[0444] Example 84. The delivery system of any example herein, particularly any one of Examples 78-80, wherein each one of the second plurality of stmts can be a zigzag stmt.

[0445] Example 85. The delivery system of any example herein, particularly any one of Examples 78-84, wherein the proximal valve positioning portion can comprise a plurality of stmts.

[0446] Example 86. The delivery system of any example herein, particularly Example 85, wherein the plurality of stmts can include a first plurality of stmts arranged in a first row that can extend in a circumferential direction of the delivery apparatus and a second plurality of stmts arranged in a second row that can extend in the circumferential direction.

[0447] Example 87. The delivery system of any example herein, particularly Example 86, wherein each one of the first plurality of struts can be a linear strut oriented at an angle relative to an axial direction of the delivery apparatus.

[0448] Example 88. The delivery system of any example herein, particularly any one of Examples 86-87, wherein each one of the second plurality of struts can be a serpentine strut.

[0449] Example 89. The delivery system of any example herein, particularly Example 88, wherein the serpentine strut can form a plurality of semicircular turns.

[0450] Example 90. The delivery system of any example herein, particularly Example 88, wherein the seipentine strut can form a plurality of curves that each extend less than 180 degrees.

[0451] Example 91. The delivery system of any example herein, particularly any one of Examples 86-87, wherein each one of the second plurality of struts can be a zigzag strut.

[0452] Example 92. The delivery system of any example herein, particularly any one of Examples 73-91, wherein the intermediate valve positioning portion can comprise a plurality of axial connecting struts that connect the distal valve positioning portion and the proximal valve positioning portion.

[0453] Example 93. The delivery system of any example herein, particularly any one of Examples 70-92, wherein the balloon can have an axial length in a range from 45 mm to 51 mm.

[0454] Example 94. The delivery system of any example herein, particularly Example 93, wherein the balloon can have an axial length in a range from 46 mm to 50 mm.

[0455] Example 95. The delivery system of any example herein, particularly any one of Examples 70-92, wherein the balloon can have an axial length in a range from 31 mm to 45 mm.

[0456] Example 96. The delivery system of any example herein, particularly Example 95, wherein the balloon can have an axial length in a range from 31 mm to 36 mm.

[0457] Example 97. The delivery system of any example herein, particularly any one of Examples 70-92, wherein the balloon can have an axial length in a range from 25 mm to 31 mm.

[0458] Example 98. The delivery system of any example herein, particularly Example 97, wherein the balloon can have an axial length in a range from 26 mm to 30 mm.

[0459] Example 99. A delivery apparatus for delivering a prosthetic valve through vasculature of a subject can comprise: a handle, a shaft, a balloon, and a valve positioning system. The shaft can be coupled to the handle. The balloon can be coupled to a distal end portion of the shaft. The balloon can be configured to be inflated from a first, deflated state to a second, radially expanded, inflated state. The balloon can have a proximal end portion, a distal end portion, and a valve mounting portion disposed between the proximal and distal end portions for mounting the prosthetic valve in a radially compressed state. The valve positioning structure can comprise a frame, wherein the valve positioning structure can be positioned radially outward of the balloon, the valve positioning structure can extend over the proximal end portion of the balloon, the valve mounting portion of the balloon, and the distal end portion of the balloon, and the valve positioning structure can be configured to radially expand from a radially collapsed state to a radially expanded state when the balloon is inflated and then radially collapse from the radially expanded state to the radially collapsed state when the balloon is deflated.

[0460] Example 100. The delivery apparatus of any example herein, particularly Example 99, wherein the valve positioning structure can extend an entire length of the balloon.

[0461] Example 101. The delivery apparatus of any example herein, particularly any one of Examples 99-100, wherein the frame can comprise a shape -memory material and can be shape set in the radially collapsed state so that the frame collapses under its own resiliency when the balloon is deflated.

[0462] Example 102. The delivery apparatus of any example herein, particularly any one of Examples 99-101, wherein the frame can comprise a plurality of interconnected struts.

[0463] Example 103. The delivery apparatus of any example herein, particularly any one of Examples 99-101, wherein the frame can comprise a braided mesh structure.

[0464] Example 104. The delivery apparatus of any example herein, particularly any one of Examples 99-103, wherein the frame of the valve positioning structure can comprise a distal valve positioning portion, a proximal valve positioning portion, and an intermediate valve positioning portion disposed between the distal valve positioning portion and the proximal valve positioning portion.

[0465] Example 105. The delivery apparatus of any example herein, particularly Example 104, wherein the distal valve positioning portion can taper towards a distal end portion of the valve positioning structure.

[0466] Example 106. The delivery apparatus of any example herein, particularly any one of Examples 104-105, wherein the proximal valve positioning portion can taper towards a proximal end portion of the valve positioning structure.

[0467] Example 107. The delivery apparatus of any example herein, particularly any one of Examples 104-106, wherein: a distal end portion of the distal valve positioning portion can define a first diameter and a proximal end portion of the distal valve positioning portion defines a second diameter, and the second diameter can be greater than the first diameter.

[0468] Example 108. The delivery apparatus of any example herein, particularly Example107, wherein: the intermediate valve positioning portion can define a third diameter, and the second diameter can be greater than the third diameter.

[0469] Example 109. The delivery apparatus of any example herein, particularly Example108, wherein: a distal end portion of the proximal valve positioning portion can define a fourth diameter and a proximal end portion of the proximal valve positioning portion can define a fifth diameter, and the fifth diameter can be greater than the fourth diameter.

[0470] Example 110. The delivery apparatus of any example herein, particularly Example109, wherein the fourth diameter can be greater than the third diameter.

[0471] Example 111. The delivery apparatus of any example herein, particularly Example110, wherein the first, third, and fifth diameters can be substantially equal.

[0472] Example 112. The delivery apparatus of any example herein, particularly Example 104, wherein a region between the distal valve positioning portion and the intermediate valve positioning portion can be flared.

[0473] Example 113. The delivery apparatus of any example herein, particularly Example 104, wherein a region between the proximal valve positioning portion and the intermediate valve positioning portion can be flared.

[0474] Example 1 14. The delivery apparatus of any example herein, particularly any one of Examples 104-113, wherein the intermediate valve positioning portion can be cylindrical.

[0475] Example 115. A delivery apparatus for a prosthetic medical device can comprise a handle, a shaft, a balloon, and a valve positioning system. The shaft can be coupled to the handle. The balloon can be coupled to a distal end portion of the shaft. The valve positioning structure can extend at least partially over an outer surface of the balloon, wherein the valve positioning structure can comprise a frame constructed of a shape-memory material.

[0476] Example 1 16. The delivery apparatus of any example herein, particularly Example 115, wherein the valve positioning structure can be not attached to the outer surface of the balloon.

[0477] Example 117. The delivery apparatus of any example herein, particularly any one of Examples 115-116, wherein a proximal end portion of the valve positioning structure can be fixed to the shaft.

[0478] Example 118. The delivery apparatus of any example herein, particularly Example 117, wherein a proximal end portion of the valve positioning structure can be fixed to an inner surface of the shaft.

[0479] Example 1 19. The delivery apparatus of any example herein, particularly Example 117, wherein a proximal end portion of the valve positioning structure can be fixed to an outer surface of the shaft.

[0480] Example 120. The delivery apparatus of any example herein, particularly any one of Examples 115-119, wherein the delivery apparatus can further comprise a nose cone distally disposed relative to the balloon and the valve positioning structure.

[0481] Example 121. The delivery apparatus of any example herein, particularly Example 120, wherein a distal end portion of the valve positioning structure can be fixed to the nose cone.

[0482] Example 122. The delivery apparatus of any example herein, particularly any one of Examples 115-121, wherein the valve positioning structure can be expandable from a radially collapsed state to a radially expanded state when the balloon is inflated to an inflated state.

[0483] Example 123. The delivery apparatus of any example herein, particularly Example 122, wherein the valve positioning structure can be collapsible from the radially expanded state to the radially collapsed state when the balloon is deflated to a deflated state.

[0484] Example 124. The delivery apparatus of any example herein, particularly Example 123, wherein the valve positioning structure can collapse under its own resiliency from the radially expanded state to the radially collapsed state.

[0485] Example 125. The delivery apparatus of any example herein, particularly any one of Examples 122-124, wherein the prosthetic medical device can be configured to be mounted around the valve positioning structure.

[0486] Example 126. The delivery apparatus of any example herein, particularly Example 125, wherein the prosthetic medical device may not contact an outer surface of the balloon when the prosthetic medical device is mounted around the valve positioning structure when the valve positioning structure is in the radially collapsed state.

[0487] Example 127. A delivery apparatus for a prosthetic medical device can comprise: a handle, a shaft, a balloon, and a valve positioning structure. The shaft can be coupled to the handle. The balloon can be coupled to a distal end portion of the shaft and can comprise an outer surface. The valve positioning structure can extend at least partially over the outer surface of the balloon and can comprise a frame that includes a plurality of struts. The frame can define an axial direction and a circumferential direction.

[0488] Example 128. The delivery apparatus of any example herein, particularly Example127, wherein the plurality of struts can comprise a first plurality of struts and a second plurality of struts.

[0489] Example 129. The delivery apparatus of any example herein, particularly Example128, wherein the first plurality of stmts can each have a linear shape.

[0490] Example 130. The delivery apparatus of any example herein, particularly any one of Examples 128-129, wherein the first plurality of stmts can be each oriented at an angle relative to the axial direction of the frame.

[0491] Example 131. The delivery apparatus of any example herein, particularly any one of Examples 128-130, wherein the first plurality of stmts can be arranged into at least one row that extends in the circumferential direction of the frame.

[0492] Example 132. The delivery apparatus of any example herein, particularly any one of Examples 128-131, wherein adjacent ends of the first plurality of stmts can point in the axial direction of the frame.

[0493] Example 133. The delivery apparatus of any example herein, particularly any one of Examples 128-132, wherein the plurality of second stmts can each have a sawtooth shape.

[0494] Example 134. The delivery apparatus of any example herein, particularly any one of Examples 128-133, wherein the plurality of second struts can be arranged into at least one row that extends in the circumferential direction of the frame.

[0495] Example 135. The delivery apparatus of any example herein, particularly any one of Examples 128-134, wherein adjacent ends of the plurality of second stmts can point in the circumferential direction of the frame.

[0496] Example 136. The delivery apparatus of any example herein, particularly any one of Examples 128-135, wherein the plurality of stmts can further comprise a third plurality of stmts.

[0497] Example 137. The delivery apparatus of any example herein, particularly Example 136, wherein: each one of the third plurality of stmts can comprise a distal end and a proximal end, each one of the third plurality of stmts can connect at its distal end to a junction of two of the first plurality of stmts, and each one of the third plurality of stmts can connect at its proximal end to a junction of another two of the first plurality of stmts.

[0498] Example 138. The delivery apparatus of any example herein, particularly any one of Examples 127-137, wherein the frame of the valve positioning structure can be a unitary stmcture.

[0499] Example 139. The delivery apparatus of any example herein, particularly any one of Examples 127-138, wherein the frame of the valve positioning stmcture can lack fasteners.

[0500] Example 140. The delivery apparatus of any example herein, particularly any one of Examples 127-140, wherein the frame of the valve positioning stmcture can be constmcted of a shape-memory material.

[0501] Example 141. The delivery apparatus of any example herein, particularly Example 140, wherein the frame is constmcted of Nitinol.

[0502] Example 142. The delivery apparatus of any example herein, particularly any one of Examples 140-141, wherein the frame of the valve positioning structure can be configured to collapse from a radially expanded state to a radially collapsed state under its own resiliency.

[0503] Example 143. The delivery apparatus of any example herein, particularly Example 143, wherein the frame can be shape set in the radially collapsed state.

[0504] Example 144. The delivery apparatus of any example herein, particularly any one of Examples 127-143, wherein the frame of the valve positioning structure can define a distal valve positioning portion, a proximal valve positioning portion, and an intermediate valve positioning portion disposed between the distal and proximal valve positioning portions.

[0505] Example 145. The delivery apparatus of any example herein, particularly Example 144, wherein the distal valve positioning portion can flare from the intermediate valve positioning portion.

[0506] Example 146. The delivery apparatus of any example herein, particularly any one of Examples 144-145, wherein the distal valve positioning portion can taper towards a distal end of the frame.

[0507] Example 147. The delivery apparatus of any example herein, particularly any one of Examples 144-146, wherein the proximal valve positioning portion can flare from the intermediate valve positioning portion.

[0508] Example 148. The delivery apparatus of any example herein, particularly any one of Examples 144-147, wherein the proximal valve positioning portion can taper towards a proximal end of the frame.

[0509] Example 149. A delivery system can comprise: a balloon, an expandable distal valve positioning structure, an expandable proximal valve positioning structure, and a prosthetic heart valve. The balloon can comprise: an outer surface extending from a distal end to a proximal end of the balloon and a valve mounting portion disposed on the outer surface between the distal and proximal ends. The expandable distal valve positioning structure can extend over a distal portion of the outer surface of the balloon. The expandable proximal valve positioning structure can extend over a proximal portion of the outer surface of the balloon. The prosthetic heart valve can be crimped around the valve mounting portion of the balloon, wherein neither the distal valve positioning structure nor the proximal valve positioning structure can overlap an outer surface of the prosthetic heart valve.

[0510] Example 150. The delivery system of any example herein, particularly Example 149, wherein each of the distal valve positioning structure and the proximal valve positioning structure can comprise a frame that includes a plurality of struts.

[0511] Example 151. The delivery system of any example herein, wherein the delivery system is sterilized.

[0512] Example 152. The delivery system of any example herein, wherein the prosthetic heart valve is sterilized.

[0513] Example 153. A method can include crimping a prosthetic valve around a valve positioning structure of a delivery system, wherein the valve positioning structure can be in a first position relative to a balloon of the delivery system, and moving the valve positioning structure in an axial direction to a second position relative to the balloon. The second position can be axially spaced apart from the first position. In the second position, inflating the balloon can be effective to radially expand the valve positioning structure and the prosthetic valve.

[0514] Example 154. The method of any example herein, particularly Example 153, can further include, prior to crimping the prosthetic valve around the valve positioning structure, de-airing the delivery system.

[0515] Example 155. The method of any example herein, particularly any one of Examples 153-154, can further include, after crimping the prosthetic valve around the valve positioning structure and prior to moving the valve positioning structure to the second position, advancing the prosthetic valve, the valve positioning structure, and the balloon through a subject’s vasculature towards a target implantation site.

[0516] Example 156. The method of any example herein, particularly Example 155, wherein the act of moving the valve positioning structure in the axial direction to the second position can be performed while the valve positioning structure and the balloon are within a descending aorta of the subject.

[0517] Example 157. The method of any example herein, particularly any one of Examples 153-156, can further include, after crimping the prosthetic valve around the valve positioning structure and before moving the valve positioning structure to the second position, measuring a crimped diameter of the prosthetic valve.

[0518] Example 158. The method of any example herein, particularly any one of Examples 153-157, can further include, after moving the valve positioning structure to the second position relative to the balloon, aligning a commissure of the prosthetic valve with a native commissure of a native aortic valve by rotating the valve positioning structure and the prosthetic valve.

[0519] Example 159. The method of any example herein, particularly any one of Examples 153-158, wherein an intermediate portion of the valve positioning structure in the second position can be aligned in the axial direction with a valve mounting portion of the balloon.

[0520] Example 160. The method of any example herein, particularly any one of Examples 153-159, can further include, after moving the valve positioning structure to the second position, inflating the balloon to radially expand the prosthetic valve and the valve mounting structure.

[0521] Example 161. A method can include crimping a prosthetic valve around an intermediate portion of a valve positioning structure, wherein the intermediate portion of the valve positioning structure can be spaced apart in an axial direction from a valve mounting portion of a balloon, aligning, within a descending aorta of a subject, the intermediate portion of the valve positioning structure in the axial direction with the valve mounting portion of the balloon, and aligning a commissure of the prosthetic valve that can be crimped around the intermediate portion of the valve mounting structure with a native aortic valve commissure of the subject.

[0522] Example 162. The method of any example herein, particularly Example 161, wherein crimping the prosthetic valve around the intermediate portion of the valve positioning structure can include reducing an outer diameter of the prosthetic valve to less than 7.5 millimeters.

[0523] Example 163. The method of any example herein, particularly Example 161, wherein crimping the prosthetic valve around the intermediate portion of the valve positioning structure can include reducing the outer diameter of the prosthetic valve to less than 7 millimeters.

[0524] Example 164. The method of any example herein, particularly any one of Examples 161-163, wherein aligning the intermediate portion of the valve positioning structure with the valve mounting portion of the balloon can include advancing the valve positioning structure in a distal direction relative to the balloon.

[0525] Example 165. The method of any example herein, particularly any one of Examples 161-164, can further include, after aligning the commissure of the prosthetic valve with the native aortic valve commissure, inflating the balloon to expand the prosthetic valve and the valve mounting structure.

[0526] Example 166. A delivery system can include a first shaft, a balloon coupled to a distal end portion of the first shaft, a second shaft, and a valve positioning structure coupled to a distal end portion of the second shaft. The second shaft and the valve positioning structure can be movable in an axial direction relative to the first shaft and the balloon.

[0527] Example 167. The delivery system of any example herein, particularly Example 166, wherein the balloon can lack a distal shoulder.

[0528] Example 168. The delivery system of any example herein, particularly any one of Examples 166-167, wherein the second shaft can be coaxially disposed around the first shaft.

[0529] Example 169. The delivery system of any example herein, particularly any one of Examples 166-168, wherein the valve positioning structure can be adapted to be movable in the axial direction relative to the first shaft and the balloon from an off-balloon position to an on-balloon position.

[0530] Example 170. The delivery system of any example herein, particularly Example 169, wherein when the valve positioning structure is in the off-balloon position, the valve positioning structure does not overlap the balloon in the axial direction.

[0531] Example 171. The delivery system of any example herein, particularly Example 169, wherein when the valve positioning structure is in the off-balloon position, the valve positioning structure can at least partially overlap the balloon in the axial direction.

[0532] Example 172. The delivery system of any example herein, particularly Example 169, wherein when the valve positioning structure is in the on-balloon position, the valve positioning structure can be radially expandable upon inflation of the balloon.

[0533] Example 173. The delivery system of any example herein, particularly any one of Examples 166-172, can further include a third shaft that can extend through the first shaft and can have a distal end portion that can extend distally past a distal end of the first shaft and through the balloon.

[0534] Example 174. The delivery system of any example herein, particularly Example 173, which can further include an extension tube extending coaxially over the third shaft from the distal end of the first shaft to a proximal end of the balloon.

[0535] Example 175. The delivery system of any example herein, particularly any one of Examples 166-174, wherein a proximal end portion of the valve positioning structure can be fixedly connected to the distal end portion of the second shaft.

[0536] Example 176. The delivery system of any example herein, particularly Example 166, can further include a third shaft extending through the first shaft and having a distal end portion that extends distally past a distal end of the first shaft and through the balloon. The delivery system can further include an extension tube extending coaxially over the third shaft from the distal end of the first shaft to a proximal end of the balloon. The valve positioning structure can be adapted to be movable in the axial direction relative to the first shaft and the balloon from an off-balloon position to an on-balloon position. When the valve positioning structure is in the off-balloon position, the valve positioning structure can overlap the extension tube.

[0537] Example 177. The delivery system of any example herein, particularly any one of Examples 166-176, can further include a prosthetic heart valve crimped around the valve positioning structure.

[0538] Example 178. A method of sterilizing any of the delivery systems described herein.

[0539] Example 179. A method of sterilizing any of the prosthetic heart valves described herein.

[0540] Thus, specific examples of delivery systems, apparatus, and methods have been disclosed. The above description of the disclosed implementations is provided to enable any person skilled in the art to make or use the devices, apparatus, systems and methods disclosed herein. The preceding detailed description illustrates examples and is not intended to limit the disclosure or the application and uses of the devices, apparatus, systems, and methods disclosed herein. Various modifications to these implementations will be readily apparent to those skilled in the art, and the general principles described herein can be applied to other implementations without departing from the spirit or scope of the disclosure. Thus, it is to be understood that the description and drawings presented herein represent an implementation of the delivery apparatuses and are therefore representative of the subject matter which is broadly contemplated by the present application. It is further understood that the scope of the present application fully encompasses other implementations that may become obvious to those skilled in the art and that the scope of the present application is accordingly not limited.

[0541] 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 expandable valve positioning structure can be combined with any one or more features of another expandable valve positioning structure.THVDL-23563 WOOlFor example, any distal valve positioning portion disclosed herein can be combined with any proximal valve positioning portion disclosed herein and any intermediate valve positioning portion disclosed herein to form a valve positioning structure. 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.

[0542] Groupings of alternative elements or implementations of the disclosure herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all groups used in the appended claims.

[0543] 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.

[0544] All structural and functional equivalents to the components of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

Claims

THVDL-23563 WOOlWE CLAIM:

1. A method comprising: crimping a prosthetic valve around a valve positioning structure of a delivery system, wherein the valve positioning structure is in a first position relative to a balloon of the delivery system; and moving the valve positioning structure in an axial direction to a second position relative to the balloon, wherein the second position is axially spaced apart from the first position, wherein, in the second position, inflating the balloon is effective to radially expand the valve positioning structure and the prosthetic valve.

2. The method of claim 1, further comprising, after crimping the prosthetic valve around the valve positioning structure and prior to moving the valve positioning structure to the second position, advancing the prosthetic valve, the valve positioning structure, and the balloon through a subject’s vasculature towards a target implantation site.

3. The method of claim 2, wherein the act of moving the valve positioning structure in the axial direction to the second position is performed while the valve positioning structure and the balloon are within a descending aorta of the subject.

4. The method of any one of claims 1-3, further comprising, after crimping the prosthetic valve around the valve positioning structure and before moving the valve positioning structure to the second position, measuring a crimped diameter of the prosthetic valve.

5. The method of any one of claims 1-4, further comprising, after moving the valve positioning structure to the second position relative to the balloon, aligning a commissure of the prosthetic valve with a native commissure of a native aortic valve by rotating the valve positioning structure and the prosthetic valve.

6. The method of any one of claims 1-5, wherein an intermediate portion of theTHVDL-23563 WOOl valve positioning structure in the second position is aligned in the axial direction with a valve mounting portion of the balloon.

7. A method comprising: crimping a prosthetic valve around an intermediate portion of a valve positioning structure, wherein the intermediate portion of the valve positioning structure is spaced apart in an axial direction from a valve mounting portion of a balloon; aligning, within a descending aorta of a subject, the intermediate portion of the valve positioning structure in the axial direction with the valve mounting portion of the balloon; and aligning a commissure of the prosthetic valve that is crimped around the intermediate portion of the valve mounting structure with a native aortic valve commissure of the subject.

8. The method of claim 7, wherein crimping the prosthetic valve around the intermediate portion of the valve positioning structure comprises reducing an outer diameter of the prosthetic valve to less than 7.5 millimeters.

9. The method of any one of claims 7-8, wherein aligning the intermediate portion of the valve positioning structure with the valve mounting portion of the balloon comprises advancing the valve positioning structure in a distal direction relative to the balloon.

10. A delivery system comprising: a first shaft; a balloon coupled to a distal end portion of the first shaft; a second shaft; and a valve positioning structure coupled to a distal end portion of the second shaft, wherein the second shaft and the valve positioning structure are movable in an axial direction relative to the first shaft and the balloon.

11. The delivery system of claim 10, wherein the second shaft is coaxially disposed around the first shaft.

12. The delivery system of any one of claims 10-11, wherein the valve positioning structure is adapted to be movable in the axial direction relative to the first shaft and the balloon from an off-balloon position to an on-balloon position.

13. The delivery system of claim 12, wherein when the valve positioning structure is in the off-balloon position, the valve positioning structure does not overlap the balloon in the axial direction.

14. The delivery system of claim 13, wherein when the valve positioning structure is in the off-balloon position, the valve positioning structure at least partially overlaps the balloon in the axial direction.

15. The delivery system of claim 14, wherein when the valve positioning structure is in the on-balloon position, the valve positioning structure is radially expandable upon inflation of the balloon.

16. The delivery system of any one of claims 10-15, further comprising a third shaft extending through the first shaft and having a distal end portion that extends distally past a distal end of the first shaft and through the balloon.

17. The delivery system of claim 16, further comprising an extension tube extending coaxially over the third shaft from the distal end of the first shaft to a proximal end of the balloon.

18. The delivery system of any one of claims 10-17, wherein a proximal end portion of the valve positioning structure is fixedly connected to the distal end portion of the second shaft.

19. The delivery system of claim 10, further comprising: a third shaft extending through the first shaft and having a distal end portion that extends distally past a distal end of the first shaft and through the balloon; andTHVDL-23563 WOOl an extension tube extending coaxially over the third shaft from the distal end of the first shaft to a proximal end of the balloon, wherein the valve positioning structure is adapted to be movable in the axial direction relative to the first shaft and the balloon from an off-balloon position to an on-balloon position, and wherein when the valve positioning structure is in the off-balloon position, the valve positioning structure overlaps the extension tube.

20. The delivery system of any one of claims 10-19, further comprising a prosthetic heart valve crimped around the valve positioning structure.

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