Frame for prosthetic heart valve

Abstract

Prosthetic heart valves are disclosed herein. In one example, a prosthetic heart valve includes a radially expandable and compressible annular frame comprising a plurality of interconnected angled struts defining a plurality of circumferentially extending rows of cells arranged between an outflow end and an inflow end of the frame, wherein the plurality of interconnected angled struts is arranged to form a plurality of circumferentially extending rows of struts, wherein an intermediate region of each strut of a first row of struts includes a thinned strut portion.

Description

FRAME FOR PROSTHETIC HEART VALVECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 662,601, filed on June 21, 2024, and U.S. Provisional Patent Application No. 63 / 720,273, filed on November 14, 2024, each of which is incorporated by reference herein in its entirety.FIELD

[0002] The present application relates to expandable prosthetic heart valves, including frames for 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 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 self-expand to its functional size.SUMMARY

[0004] Described herein are prosthetic heart valves, delivery apparatus, and methods for implanting prosthetic heart valves. The disclosed prosthetic heart valves, delivery apparatus, and methods can, for example, provide for increased over-expansion of a previously implanted prosthetic heart valve (for example, when implanting a new transcatheter heart valve in a previously implanted transcatheter heart valve (TAV-in-TAV)). As such, thedevices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatus.

[0005] One challenge associated with TAV-in-TAV procedures is that the previously implanted prosthetic valve may limit the extent to which the new prosthetic valve can expand, resulting in a reduced effective orifice area (EAO) and sub-optimum hemodynamics. For example, the frame of a previously implanted valve typically has angled struts that prevent further expansion of the frame when the angled struts are bent to define 180-degree angles between adjacent struts.

[0006] In some examples, the frame of a previously implanted prosthetic valve (referred to as a “host valve”) can comprise stmts having thinned regions which can be plastically stretched and elongated during a TAV-in-TAV procedure to overstretch and overexpand the host valve, thereby allowing a subsequently implanted valve (referred to a “guest valve”) to achieve a greater effective orifice area (EOA) when implanted within the host valve. In some examples, the EAO of the guest valve is at least the same as the EAO of the host valve. The thinned regions can allow the frame to achieve an even greater diameter by plastically deforming and elongating after the 180-degree angle is reached, thus allowing the guest valve to achieve a greater maximum diameter and EOA within the host valve.

[0007] A prosthetic heart valve can comprise a frame and a valvular structure coupled to the frame. In addition to these components, a prosthetic heart valve can further comprise one or more of the components disclosed herein.

[0008] In some examples, a prosthetic heart valve can comprise stmts having a thinned stmt region that is spaced apart from ends of the stmts.

[0009] In some examples, a prosthetic heart valve can comprise stmts having an intermediate portion that has a width that is narrower than a width of the stmt.

[0010] In some examples, a prosthetic heart valve can be expandable between an expanded configuration and an overexpanded configuration, wherein in the overexpanded configuration, thinned stmt regions of stmts are plastically elongated.

[0011] In some examples, a prosthetic heart valve can comprise struts having a thinned strut region that is spaced apart from ends of the strut, wherein the thinned stmt region has a firstlength in an expanded configuration, and wherein the thinned strut region has a second length that is longer than the first length in an overexpanded configuration.

[0012] In some examples, a prosthetic heart valve can comprise a radially expandable and compressible annular frame comprising a plurality of interconnected angled struts; wherein the plurality of interconnected angled struts is arranged to form a plurality of circumferentially extending rows of struts, including a first row of angled struts, wherein an intermediate region of at least one of the struts of the first row includes a thinned strut portion.

[0013] In some examples, a prosthetic heart valve can comprise a radially expandable and compressible annular frame comprising a plurality of interconnected angled struts defining a plurality of circumferentially extending rows of cells arranged between an outflow end and an inflow end of the frame, wherein the frame is expandable between an expanded configuration and an overexpanded configuration; wherein the plurality of interconnected angled struts is arranged to form a plurality of circumferentially extending rows of struts, wherein first struts of a first row of struts include a thinned strut portion that is spaced apart from ends of the first struts, wherein the thinned strut portion has a first length in the expanded configuration, wherein the thinned strut portion has a second length in the overexpanded configuration that is longer than the first length.

[0014] In some examples, a prosthetic heart valve can comprise a radially expandable and compressible annular frame comprising a plurality of interconnected angled struts defining a plurality of circumferentially extending rows of cells arranged between a first end and a second end of the frame; and a plurality of leaflets disposed within the frame and secured together at their adjacent sides to form commissures; wherein the plurality of interconnected angled struts is arranged to form a plurality of circumferentially extending rows of struts, including a first row of angled struts at the first end of the frame, one or more intermediate rows of angled struts, and a second row of angled struts at the second end of the frame, the one or more intermediate rows of angled struts disposed between the first row of angled struts and the second row of angled struts; wherein struts of the first row of struts include a first portion, a second portion, and an intermediate region between the first portion and the second portion, wherein a width of the first portion is greater than a width of the intermediate region, and wherein a width of the second portion is greater than a width of the intermediate region.

[0015] In some examples, a prosthetic heart valve can comprise a radially expandable and compressible annular frame comprising a plurality of interconnected angled struts defining a plurality of circumferentially extending rows of cells arranged between a first end and a second end of the frame; and a plurality of leaflets disposed within the frame and secured together at their adjacent sides to form commissures; wherein the plurality of interconnected angled struts is arranged to form a plurality of circumferentially extending rows of struts, including a first row of angled struts at the first end of the frame, one or more intermediate rows of angled struts, and a second row of angled struts at the second end of the frame, the one or more intermediate rows of angled struts disposed between the first row of angled struts and the second row of angled struts; wherein adjacent struts of the first row of angled struts form a first angle, wherein adjacent struts of the one or more intermediate rows of angled struts form a second angle that is smaller than the first angle, wherein each strut of the first row of angled struts includes a thinned strut portion located at an intermediate region of the strut.

[0016] In some examples, a prosthetic heart valve for deployment within a host valve can comprise a radially expandable and compressible annular frame comprising a plurality of interconnected angled struts, the frame having an inflow end and an outflow end, wherein the angled struts form a plurality of apices at the inflow end and the outflow end; and a valvular structure disposed within the frame, wherein when prosthetic heart valve is implanted within a host valve, the apices are capable of flaring outwards relative to the host valve.

[0017] In some examples, a prosthetic heart valve comprises one or more of the components recited in Examples 1-55 and 71-73 below.

[0018] A method of implanting a prosthetic heart valve can comprise advancing a balloon of a delivery apparatus through a patient’s vasculature to a target location; and inflating the balloon.

[0019] In some examples, a method can comprise inflating a balloon of a delivery apparatus to overexpand a previously implanted prosthetic heart valve such that thinned strut regions of the previously implanted prosthetic heart valve plastically expand.

[0020] In some examples, a method can comprise advancing a balloon of a delivery apparatus through a patient’s vasculature to a previously implanted prosthetic heart valve; and inflating the balloon of the delivery apparatus to overexpand the previously implantedprosthetic heart valve such that thinned strut regions of the previously implanted prosthetic heart valve plastically expand.

[0021] In some examples, a method can comprise advancing a guest prosthetic heart valve on a balloon of a delivery apparatus through a patient’s vasculature to a host prosthetic heart valve; and inflating the balloon of the delivery apparatus to expand the guest prosthetic heart valve against an inner surface of the host prosthetic heart valve such that a portion of a frame of the guest prosthetic heart valve flares radially outwards relative to a frame of the host prosthetic heart valve.

[0022] In some examples, a method can comprise advancing a guest prosthetic heart valve on a delivery apparatus through a patient’s vasculature to a host prosthetic heart valve; aligning an axial midpoint of the guest prosthetic heart valve with an axial midpoint of the host prosthetic heart valve; and expanding the guest prosthetic heart valve against the host prosthetic heart valve such that a frame of the guest prosthetic heart valve assumes a non- cylindrical configuration and a frame of the host prosthetic heart valve assumes an overexpanded configuration.

[0023] In some examples, a method of implanting a guest valve within a host valve can comprise advancing a guest prosthetic heart valve on a delivery apparatus through a patient’s vasculature to a host prosthetic heart valve; overexpanding the host prosthetic heart valve such that struts at an inflow end and an outflow end of a frame of the host prosthetic heart valve assume a flattened configuration; and expanding the guest prosthetic heart valve within the host prosthetic valve such that struts at an inflow end and an outflow end of a frame of the guest prosthetic heart valve bend radially outwards towards the host prosthetic heart valve.

[0024] In some examples, a method comprises one or more of the steps recited in Examples 56-70 below.

[0025] 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).

[0026] 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 identifykey 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

[0027] FIG. 1 is a side view of a prosthetic heart valve, according to one example.

[0028] FIG. 2 is a side view of a frame of the prosthetic heart valve of FIG. 1.

[0029] FIG. 3 is a side view of a portion of the frame of FIG. 2, showing the portion of the frame in a straightened (non-annular) state.

[0030] FIG. 4 is a side view of an exemplary delivery apparatus configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site.

[0031] FIG. 5 is a side view of a portion of the frame of FIG. 2 with thinned strut portions, showing the portion of the frame in an expanded configuration.

[0032] FIG. 6 is a side view of the portion of the frame of FIG. 5 in an overexpanded configuration.

[0033] FIG. 7 is a side view of a portion of the frame of FIG. 2 in expanded and overexpanded configurations.

[0034] FIG. 8 is a side view of the frame of FIG. 2 in the overexpanded configuration.

[0035] FIG. 9A is a side view of a balloon of a delivery apparatus in a non-expanded state.

[0036] FIG. 9B is a side view of the balloon of FIG. 9B in an expanded state.

[0037] FIG. 10 is a side view of a frame of a guest valve positioned within a frame of a host valve in an overexpanded configuration, according to one example.

[0038] FIG. 11 is a side view of a frame of a guest valve positioned within the frame of FIG. 2 in an overexpanded configuration.DETAILED DESCRIPTIONGeneral Considerations

[0039] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0040] 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.

[0041] 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.” 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.

[0042] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’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 patient’s body).The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0043] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”Examples of the Disclosed Technology

[0044] FIG. 1 shows a prosthetic heart valve 100 (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 patient. 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.

[0045] 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 herein by reference. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0046] The prosthetic heart valve 100 can include a stent or frame 102, a valvular structure 104, and a perivalvular outer sealing member or outer skirt 106. The prosthetic heart valve 100 (and the frame 102) can have an inflow end 108 and an outflow end 110. The valvularstructure 104 can be disposed on an interior of the frame 102 while the outer skirt 106 is disposed around an outer surface of the frame 102.

[0047] The valvular structure 104 can comprise a plurality of leaflets 112 (for example, three leaflets, as shown in FIG. 1), collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement. The leaflets 112 can be secured to one another at their adjacent sides (for example, commissure tabs) to form commissures 114 of the valvular structure 104. For example, each leaflet 112 can comprise opposing commissure tabs disposed on opposite sides of the leaflet 112 and a cusp edge portion extending between the opposing commissure tabs. The cusp edge portion of the leaflets 112 can have an undulating, curved scalloped shape, and can be secured directly to the frame 102 (for example, by sutures). However, in alternate examples, the cusp edge portion of the leaflets 112 can be secured to an inner skirt which is then secured to the frame 102. In some examples, the leaflets 112 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.

[0048] In some examples, the outer skirt 106 can be an annular skirt. In some instances, the outer skirt 106 can comprise one or more skirt portions that are connected together and / or individually connected to the frame 102. The outer skirt 106 can comprise a fabric or polymeric material, such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc. In some instances, instead of having a relatively straight upper edge portion, as shown in FIG. 1, the outer skirt 106 can have an undulating upper edge portion that extends along and is secured to the angled struts 134. Examples of such outer skirts, as well as various other outer skirts, that can be used with the frame 102 can be found in PCT Publication No. WO 2023 / 244612, which is incorporated by reference herein.

[0049] The frame 102 can be radially compressible and expandable between a radially compressed (or collapsed) configuration and a radially expanded configuration (the expanded configuration is shown in FIG. 1). The frame 102 is shown alone in FIG. 2 and a portion of the frame 102 in a straightened (non-annular) configuration is shown in FIG. 3.

[0050] The frame 102 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol) as known in the art. When constructed of a plastically-expandable material, the frame 102 - fl -(and thus the valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0051] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 102) 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 102 can comprise stainless steel. In some examples, the frame 102 can comprise cobalt-chromium. In some examples, the frame 102 can comprise nickel-cobalt- chromium. In some examples, the frame 102 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.

[0052] As shown in FIGS. 2 and 3, the frame 102 can comprise a plurality of interconnected struts 116 which form multiple rows of open cells 118 between the outflow end 110 and the inflow end 108 of the frame 102. In some examples, as shown in FIGS. 2 and 3, the frame 102 can comprise three rows of cells 118 with a first (upper in the orientation shown in FIGS. 2 and 3) row 120 of cells 118 disposed at the outflow end 110. The first row 120 of cells comprises cells 118 that are elongated in an axial direction (relative to a central longitudinal axis 122 of the frame 102), as compared to cells 118 in the remaining rows of cells. For example, the cells 118 of the first row 120 can have a longer axial length 124 (FIG. 3) than cells 118 in the remaining rows of cells, which can include a second row 126 of cells and a third row 128 of cells, the third row 128 disposed at the inflow end 108 and the second row 126 disposed between the first row 120 and the third row 128.

[0053] In some examples, as shown in FIG. 2, each row of cells comprises nine cells 118. Thus, in such examples, the frame 102 can be referred to as a nine-cell frame.

[0054] In alternate examples, the frame 102 can comprise more than three rows of cells (for example, four or five) and / or more or less than nine cells per row. In some examples, thecells 118 in the first row 120 may not be elongated compared to cells 118 in the remaining rows of cells of the frame 102 (the second row 126 and the third row 128).

[0055] The interconnected struts 116 can include a plurality of angled struts 130, 132, 134, and 136 arranged in a plurality of rows of circumferentially extending rows of angled struts, with the rows being arrayed along the length of the frame 102 between the outflow end 110 and the inflow end 108. For example, the frame 102 can comprise a first row of angled struts 130 arranged end-to-end and extending circumferentially at the inflow end 108 of the frame; a second row of circumferentially extending, angled struts 132; a third row of circumferentially extending, angled struts 134; and a fourth row of circumferentially extending, angled struts 136 at the outflow end 110 of the frame 102. The fourth row of angled struts 136 can be connected to the third row of angled struts 134 by a plurality of axially extending commissure support posts in the form of axially extending window struts 138 (or window strut portions) and a plurality of axial (or axially extending) struts 140. The axially extending window struts 138 (which can also be referred to as axial struts that include a commissure window) define commissure windows (for example, open windows) 142 that are spaced apart from one another around the frame 102, in a circumferential direction, and which are adapted to receive a pair of commissure tabs of a pair of adjacent leaflets 112 arranged into a commissure (for example, commissure 114 shown in FIG. 1). In some examples, the commissure windows 142 and / or the axially extending window struts 138 defining the commissure windows 142 can be referred to herein as commissure features or commissure supports, each commissure feature or support configured to receive and / or be secured to a pair of commissure tabs of a pair of adjacent leaflets.

[0056] One or more (for example, two, as shown in FIGS. 2 and 3) axial struts 140 can be positioned between, in the circumferential direction, two commissure windows 142 formed by the window struts 138. Since the frame 102 can include fewer cells per row (for example, nine) and fewer axial struts 140 between each commissure window 142, as compared to some more traditional prosthetic heart valves, each cell 118 can have an increased width (in the circumferential direction), thereby providing a larger opening for blood flow and / or coronary access.

[0057] Each axial strut 140 and each window strut 138 extends from a location defined by the convergence of the lower ends (for example, ends arranged inward of and farthest away from the outflow end 110) of two angled struts 136 (which can also be referred to as an upperstrut junction or upper elongated strut junction) to another location defined by the convergence of the upper ends (for example, ends arranged closer to the outflow end 110) of two angled struts 134 (which can also be referred to as a lower strut junction or lower elongate strut junction). Each axial strut 140 and each window strut 138 forms an axial side of two adjacent cells of the first row 120 of cells.

[0058] In some examples, as shown in FIG. 3, each axial strut 140 can have a width 144 (FIG. 3) that is larger than a width of the angled struts 130, 132, 134, and 136. As used herein, a “width” of a strut is measured between opposing locations on opposing surfaces of a strut that extend between the radially facing inner and outer surfaces of the strut (relative to the central longitudinal axis 122 of the frame 102). A “thickness” of a strut is measured between opposing locations on the radially facing inner surface or the radially facing outer surfaces of a strut and is perpendicular to the width of the strut. In some examples, the width 144 of the axial struts 140 is 50-200%, 75-150%, or at least 100% larger than (for example, double) the width of the angled struts of the frame 102.

[0059] By providing the axial struts 140 with the width 144 that is greater than the width of other, angled struts of the frame 102, a larger contact area is provided for when the leaflets 112 contact the wider axial struts 140 during systole, thereby distributing the stress and reducing the extent to which the leaflets 112 may fold over the axial struts 140, radially outward through the cells 118. As a result, a long-term durability of the leaflets 112 can be increased.

[0060] Since the cells 118 of the frame 102 can have a relatively large width compared to alternate prosthetic valves that have more than nine cells per row (as introduced above), the wider axial struts 140 can be more easily incorporated into the frame 102, without sacrificing open space for blood flow and / or coronary access.

[0061] Commissure tabs 115 of adjacent leaflets 112 can be secured together to form commissures 114 (FIG. 1). Each commissure 114 of the prosthetic heart valve 100 comprises two commissure tabs 115 paired together, one from each of two adjacent leaflets 112, and extending through a commissure window 142 of the frame 102. Each commissure 114 can be secured to the window struts 138 forming the commissure window 142.

[0062] The cusp edge portion (for example, scallop edge) of each leaflet 112 can be secured to the frame 102 via one or more fasteners (for example, sutures). In some examples, thecusp edge portion of each leaflet 112 can be secured directly to the struts of the frame 102 (for example, angled struts 130, 132, and 134). For example, the cusp edge portions of the leaflets 112 can be sutured to the angled struts 130, 132, and 134 that generally follow the contour of the cusp edge portions of the leaflets 112.

[0063] In some examples, the cusp edge portion of the leaflets 112 can be secured to an inner skirt and the inner skirt can then be secured directly to the frame 102.

[0064] Various methods for securing the leaflets 112 to a frame, such as the frame 102, are disclosed in PCT Publication WO2023 / 086548, which is incorporated by reference herein in its entirety.

[0065] As shown in FIGS. 2 and 3, in some examples, one or more of or each of the axial struts 140 can comprise an inflow end portion 146 (for example, an end portion that is closest to the inflow end 108) and an outflow end portion 148 that are widened relative to a middle portion 150 of the axial strut 140 (which can be defined by the width 144). In some instances, the inflow end portion 146 of the axial strut 140 can comprise an aperture 147.The apertures 147 can be configured to receive fasteners (for example, sutures) for attaching soft components of the prosthetic heart valve 100 to the frame 102. For example, in some instances, the outer skirt 106 can be positioned around the outer surface of the frame 102 and an upper or outflow edge portion of the outer skirt 106 can be secured to the apertures 147 by fasteners 149 (for example, sutures), as shown in FIG. 1.

[0066] The interconnected struts 116 can also comprise horizontal struts 182 that extend between adjacent cells 118 of a row of cells of the frame 102 (FIGS. 2 and 3). The horizontal struts 182 can extend in a circumferential direction and also be referred to as circumferentially extending struts 182. The horizontal struts 182 can connect angled struts of two adjacent rows of angled struts of the frame 102 to one another. For example, each horizontal strut 182 can connect to two angled struts of one row of struts (for example, struts 134 shown in FIG. 3) and two angled struts in another, adjacent row of struts (for example, struts 132 shown in FIG. 3). As a result, an angled strut 185 extending between an axially extending window strut 138 and the horizontal strut 182 and an angled strut 187 extending between the horizontal strut 182 and another horizontal strut 182 disposed adjacent to the inflow end 108 of the frame 102 can be aligned along an angled line that can follow a scallop line of the leaflets (when the leaflets are attached to the frame 102). Thus, the horizontal struts 182 can allow the angled struts to follow a shape that more closely matches a shape ofthe scallop line of the leaflets when the frame 102 is in the radially expanded configuration (as shown in FIGS. 2 and 3). Additionally, the horizontal struts 182 can serve as spacers that can maintain a specified gap between the angled struts when the frame 102 is in the radially compressed configuration, thereby reducing a risk of pinching the leaflets between the struts in the radially compressed configuration.

[0067] The frame 102 can further comprise a plurality of apex regions 152 formed at the inflow end 108 and the outflow end 110, each apex region 152 extending and forming a junction between two angled struts 130 at the inflow end 108 or two angled struts 136 at the outflow end 110. As such, the apex regions 152 are spaced apart from one another, in a circumferential direction at the inflow end 108 and the outflow end 110.

[0068] Each apex region 152 can comprise an apex 154 (the highest or most outward extending, in an axial direction, point) and two thinned (or narrowed) strut portions 156, one thinned strut portion 156 extending from either side of the apex 154 to a corresponding, wider, angled strut 136 (at the outflow end 110) or angled strut 130 (at the inflow end 108) (FIG. 3). In this way, each of the apex regions 152 at the outflow end 110 can form a narrowed transition region between and relative to the two angled struts 136 extending from the corresponding apex region 152 and each of the apex regions 152 at the inflow end 108 can form a narrowed transition region between and relative to the two angled struts 130 extending from the corresponding apex region 152.

[0069] The thinned strut portions 156 of the apex regions 152 can have a width 158 that is smaller than a width 160 of the angled struts 130 or 136 (FIG. 3). In some examples, the width 158 can be a uniform width (for example, along an entire length of the strut portion 156). In some examples, the width 158 of the thinned strut portions 156 can be from about 0.06 - 0.15 mm smaller than the width 160 of the angled struts 130 and / or 136.

[0070] The thinned strut portions 156 of the apex regions 152 can have a first length 162 (FIG. 3). In some examples, the first length 162 is in a range of 0.8-1.4 mm, 0.9-1.2 mm, 0.95-1.05 mm, or about 1.0 mm (for example, ±0.03 mm). In alternate examples, the first length 162 is in a range of 0.3-0.7 mm, 0.4-0.6 mm, 0.45-0.55 mm, or about 0.5 mm (for example, ±0.03 mm).

[0071] Thus, each outflow apex region 152 can include two thinned strut portions 156 having the first length 162, each extending from the apex 154, outward relative to a centrallongitudinal axis 164 of the cells 118. Thus, a total length of the apex region 152 can be two times the first length 162.

[0072] Each apex region 152 and two corresponding angled struts 136 at the outflow end 110 can form an outflow strut 166 and each apex region 152 and two corresponding angled struts 130 at the inflow end 108 can form an inflow strut 168.

[0073] Each outflow strut 166 and inflow strut 168 can have a length that includes an apex region 152 and the two angled struts 136 or 130 (or strut portions), respectively, on either side of the apex region 152. One half the total length of each outflow strut 166 and inflow strut 168 is shown in FIG. 3 as length 170, which extends from an end of one angled strut 136 or 130 to the central longitudinal axis 164. Thus, the length of each outflow strut 166 and inflow strut 168 is two times length 170. In some examples, the length 170 for half of each inflow strut 168 can be different than the length 170 for half of each outflow strut 166.

[0074] In some instances, the length of each thinned strut portion 156 can be at least 25% of the length 170 of the corresponding half outflow strut 166 or inflow strut 168. Said another way, the length of each apex region 152 (a total length being two times the first length 162) can be at least 25% of the total length (two times length 170) of the outflow strut 166 or inflow strut 168. In some examples, the length of each apex region 152 can be more than 25% of the total length of the corresponding outflow strut 166 or inflow strut 168, such as 25- 35%.

[0075] In some examples, each apex region 152 can comprise a curved, axially facing outer surface 172 and an arcuate or curved, axially facing inner depression 174 which forms the thinned strut portions 156. For example, the curved inner depression 174 can depress toward the curved outer surface 172 from an inner surface of the angled strut portions 156, thereby forming the smaller width thinned strut portions 156. Thus, the curved inner depressions 174 can be formed on a cell side of the apex region 152 (for example, as opposed to the outside of the apex region 152).

[0076] In some examples, the curved outer surface 172 of each apex region 152 can form a single, continuous curve from one angled strut portion 156 on a first side of the apex region 152 to another angled strut portion 156 on an opposite, second side of the apex region 152 (for example, the curved outer surface 172 can have a constant convex curvature).

[0077] As used herein, “constant convex curvature” can refer to a continuously curved surface which is convex and which does not have an inflection point (no change in direction of the curvature).

[0078] Each apex region 152 can have a radius of curvature 176, along the curved outer surface 172 (for example, in some instances, along an entirety or an entire length of the curved outer surface 172) (FIG. 3). In some instances, the radius of curvature 176 at the apex 154 and / or along the entire curved outer surface 172 of the apex region 152 can be greater than 1 mm. In some instances, the radius of curvature 176 can be in a range of 1-20 mm, 3- 16 mm, or 8-14 mm. In some instances, the radius of curvature 176 can be greater than 10 mm. The radius of curvature 176 can be dependent on (and thus change due to changes in) the width 158 (for example, the amount of reduction in width from the angled struts 130 or 136) and the first length 162 of the thinned strut portions 156.

[0079] Further, a height (an axial height) 178 of the apex regions 152, which can be defined in the axial direction from an outer surface of the two angled struts 130 or 136 to the curved outer surface 172 of the apex region 152 at the apex 414, can be the width 158 of the thinned strut portions 156 (FIG. 3). In this way, the height 178 of the apex regions 152 can be relatively small and not add much to the overall axial height of the radially expanded frame 102. Thus, the leaflets 112 secured to the frame 102 (FIG. 1) can be disposed close to the inflow end 108, thereby leaving a larger open space at the outflow end 110 of the frame 102 that is not blocked by the leaflets 112.

[0080] In some examples, each of the apex region 152 can form an angle 180 between the two angled struts 130 or 136 extending from either side of the corresponding apex region 152 (FIG. 3). In some instances, the angle 180 can be in a range of 120 (not inclusive) to 140 degrees (for example, such that the angle 180 is greater than 120 degrees and less than or equal to 140 degrees). In some examples, an angle 184 can be formed between two adjacent struts 132 or 134 that is less than the angle 180.

[0081] Additional details and examples of frames for prosthetic heart valves that include apex regions can be found in PCT Publication No. WO2022 / 226147, which is incorporated by reference herein in its entirety.

[0082] FIG. 4 shows a delivery apparatus 200, according to an example, that can be used to implant an expandable prosthetic heart valve (for example, the prosthetic heart valve 100 ofFIG. 1 and / or any of the other prosthetic heart valves described herein). In some examples, the delivery apparatus 200 is specifically adapted for use in introducing a prosthetic valve into a heart.

[0083] The delivery apparatus 200 in the illustrated example of FIG. 4 is a balloon catheter comprising a handle 202 and a steerable, outer shaft 204 extending distally from the handle 202. The delivery apparatus 200 can further comprise an intermediate shaft 206 (which also may be referred to as a balloon shaft) that extends proximally from the handle 202 and distally from the handle 202, the portion extending distally from the handle 202 also extending coaxially through the outer shaft 204. Additionally, the delivery apparatus 200 can further comprise an inner shaft 208 extending distally from the handle 202 coaxially through the intermediate shaft 206 and the outer shaft 204 and proximally from the handle 202 coaxially through the intermediate shaft 206.

[0084] The outer shaft 204 and the intermediate shaft 206 can be configured to translate (for example, move) longitudinally, along a central longitudinal axis 220 of the delivery apparatus 200, relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a patient’s body.

[0085] The intermediate shaft 206 can include a proximal end portion 210 that extends proximally from a proximal end of the handle 202, to an adaptor 212. A rotatable knob 214 can be mounted on the proximal end portion 210 and can be configured to rotate the intermediate shaft 206 around the central longitudinal axis 220 and relative to the outer shaft 204.

[0086] The adaptor 212 can include a first port 238 configured to receive a guidewire therethrough and a second port 240 configured to receive fluid (for example, inflation fluid) from a fluid source. The second port 240 can be fluidly coupled to an inner lumen of the intermediate shaft 206.

[0087] The intermediate shaft 206 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 204 when a distal end of the outer shaft 204 is positioned away from an inflatable balloon 218 of the delivery apparatus 200. A distal end portion of the inner shaft 208 can extend distally beyond the distal end portion of the intermediate shaft 206.

[0088] The balloon 218 can be coupled to the distal end portion of the intermediate shaft 206.

[0089] In some examples, a distal end of the balloon 218 can be coupled to a distal end of the delivery apparatus 200, such as to a nose cone 222 (as shown in FIG. 4), or to an alternate component at the distal end of the delivery apparatus 200 (for example, a distal shoulder). An intermediate portion of the balloon 218 can overlay a valve mounting portion 224 of a distal end portion of the delivery apparatus 200 and a distal end portion of the balloon 218 can overly a distal shoulder 226 of the delivery apparatus 200. The valve mounting portion 224 and the intermediate portion of the balloon 218 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG. 4, a prosthetic heart valve 250 (which can be one of the prosthetic valves described herein) can be mounted around the balloon 218, at the valve mounting portion 224 of the delivery apparatus 200.

[0090] The balloon shoulder assembly, including the distal shoulder 226, is configured to maintain the prosthetic heart valve 250 (or other medical device) at a fixed position on the balloon 218 during delivery through the patient’s vasculature.

[0091] The outer shaft 204 can include a distal tip portion 228 mounted on its distal end. The outer shaft 204 and the intermediate shaft 206 can be translated axially relative to one another to position the distal tip portion 228 adjacent to a proximal end of the valve mounting portion 224, when the prosthetic valve 250 is mounted in the radially compressed state on the valve mounting portion 224 (as shown in FIG. 4) and during delivery of the prosthetic valve to the target implantation site. As such, the distal tip portion 228 can be configured to resist movement of the prosthetic valve 250 relative to the balloon 218 proximally, in the axial direction, relative to the balloon 218, when the distal tip portion 228 is arranged adjacent to a proximal side of the valve mounting portion 224.

[0092] An annular space can be defined between an outer surface of the inner shaft 208 and an inner surface of the intermediate shaft 206 and can be configured to receive fluid from a fluid source via the second port 240 of the adaptor 212. The annular space can be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 208 and an inner surface of the balloon 218. As such, fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the balloon 218 and radially expand and deploy the prosthetic valve 250.

[0093] An inner lumen of the inner shaft can be configured to receive a guidewire therethrough, for navigating the distal end portion of the delivery apparatus 200 to the target implantation site.

[0094] The handle 202 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 200. In the illustrated example, for example, the handle 202 includes an adjustment member, such as the illustrated rotatable knob 260, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 202 through the outer shaft 204 and has a distal end portion affixed to the outer shaft 204 at or near the distal end of the outer shaft 204. Rotating the knob 260 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 200. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein.

[0095] The handle 202 can further include an adjustment mechanism 261 including an adjustment member, such as the illustrated rotatable knob 262, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 278. The adjustment mechanism 261 is configured to adjust the axial position of the intermediate shaft 206 relative to the outer shaft 204 (for example, for fine positioning at the implantation site). Further details on the delivery apparatus 200 can be found in PCT Publication No. WO2022 / 046585 which is incorporated by reference herein in its entirety.

[0096] During a valve-in- valve procedure, a previously implanted prosthetic heart valve, such as the prosthetic heart valve 100, may be overexpanded (for example, expanded to a diameter that is greater than a working diameter of the previously implanted prosthetic heart valve) to allow a subsequently implanted prosthetic heart valve to be implanted within the previously implanted prosthetic heart valve 100. In some examples, the host prosthetic heart valve 100 may be overexpanded by a balloon of a delivery apparatus, such as balloon 218 of delivery apparatus 200. In some examples, overexpansion of the host prosthetic heart valve 100 may occur prior to and / or separate from expansion of the guest prosthetic heart valve within the host valve. For example, the balloon 218 may expand against the inner surfaces of the host heart valve 100 to overexpand the host prosthetic heart valve 100. Thereafter, the guest prosthetic heart valve 100 may be implanted within the previously implanted prosthetic heart valve 100.

[0097] In some examples, the previously implanted prosthetic heart valve 100 is expanded by a balloon 218 that is carrying the subsequently implanted prosthetic heart valve, such that both prosthetic heart valves are expanded at the same time. For example, the balloon 218 may expand against the subsequently implanted prosthetic heart valve which in turn expands against the previously implanted prosthetic heart valve 100 to overexpand the previously implanted prosthetic heart valve 100.

[0098] When the previously implanted prosthetic heart valve 100 is overexpanded, the plurality of angled struts 130, 132, 134, and 136 bend, such that a greater angle is formed between each pair of adjacent angled struts 130, 132, 134, 136 and an inner diameter of the prosthetic heart valve 100 is increased. For example, the angle 180 can increase from a range of 120 degrees to 140 degrees to approximately 180 degrees. Because the angle 180 is greater than the angle 184, the struts 130, 136 forming the angle 180 will reach a limiting angle (for example, 180 degrees) before the struts 132, 134 forming the angle 184 reach a limiting angle. Once the struts 130, 136 are bent to the limiting angle, the struts 130, 136 assume a flattened configuration and cannot be bent further to achieve a greater inner diameter. Thus, in some examples, the frame of a previously implanted prosthetic heart valve may limit the size to which the subsequently implanted prosthetic heart valve may be expanded.

[0099] To prevent the previously implanted prosthetic heart valve 100 from limiting the diameter to which a subsequently implanted prosthetic valve can be expanded, thinned strut portions of a frame can be plastically deformed and elongated to achieve a greater diameter. For example, applying additional force to the frame 102 of the previously implanted prosthetic heart valve 100, for example, via balloon 218 of the delivery apparatus 200, can apply circumferential stretching forces to create plastic elongation of the thinned strut portions 156.

[0100] FIG. 7 illustrates multiple stages of expansion as a portion of the frame 102 is expanded from a working configuration (at the top of the figure) to an overexpanded configuration (at the bottom of the figure). As the frame 102 is expanded from a working or an expanded configuration to an overexpanded configuration, the struts 136 bend such that the angle 180 between the struts 136 increases, which causes an inner diameter of the frame 102 to increase. For example, as shown in FIG. 7, the angle 180 can be 180 degrees in the overexpanded configuration. As such, in the overexpanded configuration, the angled struts 136 assume a flattened or substantially flattened configuration.

[0101] Moreover, as the frame 102 is overexpanded in a valve-in-valve procedure, the angle 180 between adjacent struts 136 increases to 180 degrees, beyond which the bending forces acting on the struts become circumferential stretching (tensile) forces that act along the length of the struts. Because the struts 136 are weakened at the thinned strut portions 156, the thinned strut portions 156 can plastically elongate in the circumferential direction due to the tensile forces when the frame is overexpanded from the working configuration to the overexpanded configuration. Moreover, the width 158 of the thinned strut portions 156 can decrease (at least at the middle of the thinned struts portions) when the frame is the overexpanded configuration.

[0102] FIG. 8 illustrates the frame 102 in the overexpanded configuration. As shown, when the previously implanted prosthetic heart valve 100 is overexpanded, the plurality of angled struts 130, 132, 134, and 136 bend from the working configuration (FIG. 2), such that a greater angle is formed between each pair of adjacent angled struts 130, 132, 134, 136 and an inner diameter of the prosthetic heart valve 100 is increased. For example, the struts 130, 136 forming the angle 180 form an angle of approximately 180 degrees, whereas the struts 132 forming the angle 184 form an angle that is less than the angle 180, such as an angle of less than 180 degrees. Further, the thinned struts portions 156 can plastically elongate to further increase the diameter of the frame for receiving a guest valve.

[0103] In some examples, a frame of a prosthetic heart valve may include a plurality of thinned strut portions, for example, in addition to the thinned strut portions 156 at the apex regions 152 of the frame 102. In some examples, the additional thinned strut portions may increase the diameter to which a previously implanted prosthetic heart valve may be overexpanded and / or can permit overexpansion with less force. FIGS. 5-6 illustrate a portion of the frame 102 for the prosthetic heart valve 100 that includes a plurality of thinned strut portions 186 in addition to thinned strut portions 156. In some examples, the frame 102 includes thinned strut portions 186 in lieu of thinned strut portions 156. FIG. 5 illustrates the frame 102 in an expanded configuration (which can be the expanded, functional state of the host valve before it is replaced), such as before overexpansion of the frame 102. FIG. 6 illustrates the frame 102 in an overexpanded configuration.

[0104] As shown in FIGS. 5-6, each angled strut 136 of the outflow row of struts includes a thinned strut portion 186. In some examples, only the outflow row of struts 136 includes one or more thinned strut portions 186, while the remaining rows of struts (which typically aredisposed in the native annulus when the prosthetic valve is implanted) do not have any thinned strut portions 186. This can permit sufficient overexpansion of the outflow end of the frame 102 (thus achieving a desired EOA for the guest valve) while preventing or minimizing the risk of annular rupture.

[0105] While the angled struts 136 are shown as having the thinned strut portions 186, it should be appreciated that other struts 116 of the frame 102 may include thinned strut portions. In some examples, each strut 116 includes a thinned strut portion 186. In some examples, one of more angled struts of the inflow row of struts 130 and / or the outflow row of struts 136 include thinned strut portions 186, for example, on either side of the apex region 152. In some examples, the third row of struts 134 and the fourth row of struts 136 may include the thinned strut portion 186. In some examples, every other strut in a row of struts 116 includes thinned strut portions 186. In some examples, the row(s) of struts 116 forming the greatest angle(s) between adjacent struts 116 include thinned strut portions 186. In some examples, a frame 102 can have any combination of angled struts having thinned struts portions 186 in the first row of struts 130, the second row of struts 132, the third row of struts 134, and / or the fourth row of struts 136.

[0106] Each angled strut 136 extends between a first junction 188 at the apex region 152 to a second junction 190. The second junction 190 is formed at a location where two angled struts 136 converge with an axial strut 140 or a window strut 138. In other words, one angled strut 136 extends between the first junction 188 and the second junction 190.

[0107] In some examples, the thinned strut portions 186 are positioned in an intermediate region between the first junction 188 and the second junction 190. For example, the thinned strut portion 186 can be midway between the first junction 188 and the second junction 190, at a midpoint of the strut 136. Similarly, when other angled struts of the frame included thinned strut portions 186, the thinned strut portions can be positioned along an intermediate region located between the opposing ends of the strut, such as midway between the opposing ends of the strut.

[0108] The thinned strut portions 186 of the angled struts 136 can have a width 192 that is smaller than the width 160 adjacent portions of the angled struts 136 that extend from the thinned struts portions. In some examples, the width 192 can be a uniform width (for example, along an entire length of the thinned strut portion 186). In some examples, the width 192 of the thinned strut portions 186 can be from about 0.20 - 0.30 mm smaller thanthe width 160 of the angled struts 136. For example, the width 160 of the angled struts 136 can be in a range of 0.30 - 0.40 mm and the width 192 of the thinned strut portions 186 can be approximately 0.1 mm, for example, in a range of 0.05 - 0.15 mm.

[0109] In some examples, the angled struts 136 can include a first portion 194 positioned adjacent to the second junction 190 and a second portion 196 positioned adjacent to the apex region 152. For example, the first portion 194 can extend from the second junction 190 to the thinned strut portion 186 and the second portion 196 can extend from the thinned strut portion 186 to the apex region 152. The first portion 194 and the second portion 196 have a width 160 that is greater than the width 192 of the thinned strut portions 186. In some examples, as shown, the first portion 194 and the second portion 196 have the same width 160.

[0110] The thinned strut portion 186 has an axially-facing outflow surface 186a that faces towards an outflow end of the frame 102 and an axially-facing inflow surface 186b that faces towards an inflow end of the frame 102. In some examples, as shown, both of the axially- facing outflow surface 186a and the axially-facing inflow surface 186b of the thinned strut portion 186 are recessed from outflow and inflow surfaces of the first and second portions 194, 196 of the strut 136 such that the thinned strut portion 186 is centrally located between the outflow and inflow surfaces of the first and second portions 194, 196 of the strut 136. In some examples, either the axially-facing outflow surface 186a or the axially-facing inflow surface 186b is recessed from an outflow or an inflow surface of the first and second portions 194, 196 (but not both) strut 136, such that the thinned strut portion 186 is offset from a central longitudinal axis of the strut 136. In some examples, the surfaces 186a, 186b are recessed relative to the first and second portions 194, 196 by different amounts.

[0111] As described above, the frame 102 of the prosthetic heart valve 100 (when being replaced with a guest valve) can be overexpanded during a TAV-in-TAV procedure to maximize the expanded diameter of the guest valve implanted within the host valve 100. As the frame 102 is expanded from a working or an expanded configuration (FIG. 5) to an overexpanded configuration (FIG. 6), the struts 136 bend at the junctions 188 and 190, such that the angle 180 between the struts 136 increases and an inner diameter of the frame 102 is increased. In the overexpanded configuration, the angle 180 can be within a range of about 160 degrees to about 180 degrees, about 170 degrees to about 180 degrees, about 175 degreesto about 180 degrees. As such, in the overexpanded configuration, the angled struts 136 assume a flattened or substantially flattened configuration.

[0112] During normal crimping and expansion of the frame 102 (when the host valve 100 is first implanted in a patient), most of the strain experienced by an angled strut 136 occurs at the junctions 188 and 190, with little or no strain along the thinned strut portions 186. Thus, in some examples, the width 192 of the strut can be much smaller than the width 160 along the first and second portions 194, 196 without sacrificing the structural integrity of the frame 102. As the frame 102 is overexpanded in a valve-in-valve procedure, the angle 180 between adjacent struts 136 increases to 180 degrees, beyond which the bending forces acting on the struts become circumferential stretching (tensile) forces that act along the length of the struts. Because the struts 136 are weakened at the thinned strut portions 186, the thinned strut portions 186 can plastically elongate in the circumferential direction due to the tensile forces when the frame is overexpanded from the working configuration (FIG. 5) to the overexpanded configuration (FIG. 6). Moreover, the width 192 of the thinned strut portions 186 can decrease (at least at the middle of the thinned struts portion) when the frame is the overexpanded configuration. In some examples, the thinned strut portions 156 can also plastically elongate in the circumferential direction. For example, the width 158 (FIG. 3) of the thinned strut portions 156 can be smaller in the overexpanded configuration (FIG. 6) than in the working configuration (FIG. 5).

[0113] In some examples, the force required to produce plastic elongation of the thinned strut portions 156 and / or the thinned strut portions 186 is larger than the force required to achieve an angle of about 160 degrees, 170 degrees, and / or 175 degrees between adjacent struts 136, thereby obtaining a stabilizing effect at large angles between the struts and ensuring that regional under-expansion is limited.

[0114] In some examples, the thinned strut portions 156 and / or the thinned strut portions 186 are designed to only elongate after the valve 100 is expanded beyond the upper working range of the valve. In other words, the thinned strut portions 156 and / or the thinned strut portions 186 do not elongate when the valve 100 is at or below its upper working range. For example, when the valve 100 is designed to work at a size range of 22-23.5 mm and the struts 136 form an angle 180 of 140 degrees at the upper end of the working range (for example, at 23.5 mm), elongation of the thinned strut portions 156 and / or the thinned strut portions 186does not occur before the struts 136 have reached an angle 180 that is greater than 140 degrees by a margin. In some examples, the margin is 10 degrees.

[0115] In some examples, the thinned strut portions 156 and / or the thinned strut portions 186 can elongate with a balloon 218 that has a working pressure of up to 6 atm, up to 8 atm, or up to 10 atm. In some examples, to prevent inadvertent elongation, the thinned strut portions 156 and / or the thinned strut portions 186 can elongate only at higher pressures, for example, with a non-compliant balloon (for example, True balloon) which has a higher working pressure.

[0116] In some examples, during a TAV-in-TAV procedure, the structural integrity of the previously implanted prosthetic heart valve need not be maintained. Thus, in some examples, the thinned strut portions 156 and / or the thinned strut portions 186 can serve as frangible regions of the struts 136, which can be allowed to break when overstretched by a balloon (for example, balloon 218 of delivery apparatus 200) delivering a subsequently implanted prosthetic heart valve in a TAV-in-TAV procedure.

[0117] FIGS. 9A and 9B illustrate the balloon 218 of the delivery apparatus 200 with an optional band 230 that is configured to prevent or minimize the risk of annular rupture, for example, in a TAV-in-TAV procedure. As shown in FIGS. 9A-9B, the band 230 is positioned around a distal end portion 232 of the balloon 218 (for example, adjacent to the nose cone 222) and is configured to limit the expansion of the balloon 218 in that region. For example, in the expanded configuration (FIG. 9B), the diameter 234 of the balloon 218 at the distal end portion 232 where the band 230 is positioned is smaller than the diameter 236 of the remainder of the balloon 218 (for example, the portion of the balloon 218 that is not restricted by the band 230). When a host valve 100 is expanded by the balloon 218 and the band 230 in a TAV-in-TAV procedure, the band 230 can be aligned with the portion of the host valve 100 that is disposed within the native annulus (for example, the inflow portion of the host valve). In this way, the outflow portion of the host valve 100 can be expanded to a greater diameter than an inflow portion of the host valve (which is typically disposed within the native annulus). This can permit sufficient overexpansion of the outflow end of the host valve 100 (thus achieving a desired EGA for the guest valve) while preventing or minimizing the risk of annular rupture.

[0118] As described above, during a valve-in-valve procedure, a host valve may be overexpanded for a guest valve to be implanted within the host valve. FIG. 10 illustrates aknown valve-in-valve configuration where a frame 302a of a host valve is in an overexpanded configuration (also referred to herein as “host frame 302a”) with a frame 302b of a guest valve (also referred to herein as “guest frame 302b”) implanted within the host frame 302a. While only the frames of the guest valve and the host valve are shown in FIG. 10 for purposes of illustration, it should be appreciated that the other components of the valves (for example, the leaflets, etc.) would be present when a valve-in-valve procedure is performed.

[0119] As shown in FIG. 10, the host frame 302a and the guest frame 302b are in a straight or cylindrical configuration. For example, the guest frame 302b is cylindrical and has a constant diameter along its axial length (for example, from an inflow end to an outflow end). When the host frame 302a is in the overexpanded configuration, struts 330 at an inflow end 308 of the host frame 302a and struts 336 at an outflow end 310 of the host frame 302a are angled (for example, less than 180 degrees) and the inflow and outflow apices of the host frame 302a can overlap and contact adjacent struts along the inflow and outflow ends of the guest frame 302b. This is different than the frame 102 which can achieve a flattened configuration in the overexpanded state. As such, when the guest frame 302b is implanted within the host frame 302a, the angled struts 330, 336 of the host frame 302a and / or the inflow and outflow apices of the host frame 302a retain the guest frame 302b in the straight or cylindrical configuration, preventing the guest frame 302b from assuming a non-straight or non-cylindrical configuration.

[0120] FIG. 11 illustrates a frame 402 of a guest valve (also referred to herein as “guest frame 402”) implanted within the frame 102 of the host valve 100 in the overexpanded configuration (also referred to herein as “host frame 102”). While only the frames of the guest valve and the host valve are shown in FIG. 11 for purposes of illustration, it should be appreciated that the other components of the valves (for example, the leaflets, etc.) would be present when a valve-in-valve procedure is performed.

[0121] Similar to frame 102, the frame 402 can comprise a plurality of interconnected struts arranged in a plurality of circumferentially extending rows of angled struts, with the rows being arrayed along the length of the frame 402 between an outflow end 410 and an inflow end 408 of the frame 402. For example, the frame 402 can include an inflow row of angled struts 430 arranged end-to-end and extending circumferentially at the inflow end 408 of the frame 402 and an outflow row of circumferentially extending, angled struts 436 at theoutflow end 410 of the frame 402. In some examples, the frame 402 may have the same configuration and / or may be the same size as frame 102 discussed above.

[0122] As shown in FIG. 11, the guest frame 402 is disposed within the host frame 102. The host frame 102 has been overexpanded (for example, by the balloon 218 of the delivery apparatus 200) and the guest frame 402 is expanded within the host frame 102. As described above, overexpansion of the host frame 102 may occur prior to delivery and expansion of the guest frame 402 within the host frame 102. In some examples, the host frame 102 and the guest frame 402 are expanded in the same procedural step by expanding the guest frame 402 within the host frame 102 with the balloon 218 or another expansion device, which causes the guest frame 402 to radially expand and then cause the host frame 102 to overexpand once the guest frame 402 comes into contact with the host frame 102.

[0123] The guest frame 402 in the expanded configuration has a smaller circumference and diameter than the host frame 102 in the overexpanded configuration. Additionally, the guest frame 402 in the expanded configuration has a longer axial length than the host frame 102 in the overexpanded configuration. If the host frame 102 and the guest frame 402 are of the same size and configuration, the host frame 102 becomes slightly shorter in length than the guest frame 402 due to foreshortening of the host frame 102 when it is overexpanded. In some examples, an axial midpoint of the guest frame 402 (the axial midpoint being a location equidistant from the inflow and outflow ends of the frame) is aligned with an axial midpoint of the host frame 102 when the guest frame 402 is implanted within the host frame 102. As such, in these examples, at least portions of the inflow end 408 of the guest frame 402 extend beyond the inflow end 108 of the host frame 102 in the upstream direction and at least portions of the outflow end 410 of the guest frame 402 extend beyond the outflow end 1 10 of the host frame 102 in the downstream direction.

[0124] When the guest frame 402 is implanted within the host frame 102, the guest frame 402 is expanded to contact an inner surface of the host valve 100. In FIG. 11, the guest frame 402 is shown as contacting an inner surface of the host frame 102. Due to the flattened configuration of the struts 130, 136 of the host frame 102 in the overexpanded configuration, the expansion forces on the guest frame 402 (for example, by a balloon 218 of a delivery apparatus 200, etc.) cause at least portions of the struts 430, 436 at the inflow and outflow ends 408, 410 of the guest frame 402 to bend outwardly relative to the host frame 102 at the location where the struts 430, 436 contact the flattened struts 130, 136 of the host frame 102.As such, rather than remaining in a straight or cylindrical configuration, the guest frame 402 assumes a non-cylindrical configuration, where the inflow end 408 and the outflow end 410 of the frame 402 have a greater diameter than a central portion of the frame 402 between the inflow end 408 and the outflow end 410. In this manner, the host frame 102 functions as a belt to restrict expansion of a portion of the guest frame 402 (for example, the central portion between the inflow end 408 and the outflow end 410), while the inflow and outflow ends 408, 410 are permitted to further expand. In this way, the struts 430, 436 of the guest frame 402 flare radially outwards over the inflow end 108 and the outflow end 110 of the host frame 102, respectively.

[0125] As shown in FIG. 11, the struts 430, 436 extend in a radial direction towards the host frame 102 and away from an interior of the guest frame 402. Each of the struts 430, 436 around the circumference of the guest frame 402 flares radially outwards when the guest frame 402 is expanded within the host frame 102. In some examples, as shown, the flared struts 430, 436 wrap partially around the inflow and outflow ends 108, 110 of the host frame 102. In this way, the struts 430 at the inflow end 408 of the guest valve 402 are disposed axially beyond the inflow end 108 of the host frame 102 and the struts 436 at the outflow end 410 of the guest valve 402 are disposed axially beyond the outflow end 110 of the host frame 102. In some examples, the guest valve 402 extends beyond the axial length of the host frame 102 and can abut the inflow end 108 of the host frame 102 and the outflow end 110 of the host frame 102.

[0126] In some examples, the flared struts 430, 436 at the inflow end 408 and the outflow end 410 of the guest frame 402 help to anchor the guest frame 402 relative to the host frame 102. In some examples, the flared struts 430, 436 can minimize and / or prohibit axial movement between the guest frame 402 and the host frame 102 by providing axial limits to such relative movement.

[0127] In some examples, the flared struts 430, 436 at the inflow end 408 and the outflow end 410 of the guest frame 402 help to anchor the guest frame 402 and the host frame 102 relative to the native anatomy. For example, the flared struts 430, 436 can extend radially outwards beyond the radially outer surface of the host frame 102 and engage with the native anatomy.

[0128] In some examples, as shown in FIG. 11, the guest frame 402 is axially aligned with the host frame 102 in the valve-in-valve configuration (for example, the axial midpoints ofthe guest frame 402 and the host frame 102 are aligned). In some examples, the guest frame 402 is axially offset from the host frame 102 in the valve-in-valve configuration, such that the axial midpoints of the guest frame 402 and the host frame 102 are offset in the axial direction. In these examples, a longer portion of the inflow struts 430, for example, may be flared than the outflow struts 436.

[0129] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.

[0130] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with the body parts, tissue, etc. being simulated), etc.Delivery Techniques

[0131] 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 thedelivery 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.

[0132] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. 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.

[0133] 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.

[0134] 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.

[0135] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’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.Additional Examples of the Disclosed Technology

[0136] 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.

[0137] Example 1. A prosthetic heart valve comprising: a radially expandable and compressible annular frame comprising a plurality of interconnected angled struts; wherein the plurality of interconnected angled struts is arranged to form a plurality of circumferentially extending rows of struts, including a first row of angled struts, wherein an intermediate region of at least one of the struts of the first row includes a thinned strut portion.

[0138] Example 2. The prosthetic heart valve of any example herein, particularly example 1, wherein the thinned strut portion is located at a midpoint of the strut.

[0139] Example 3. The prosthetic heart valve of any example herein, particularly either example 1 or example 2, wherein the first row of struts defines an outflow end of the frame.

[0140] Example 4. The prosthetic heart valve of any example herein, particularly any one of examples 1-3, wherein at least one strut of a second row of struts includes a thinned strut portion.

[0141] Example 5. The prosthetic heart valve of any example herein, particularly any one of examples 1-4, wherein a width of the thinned strut portion is 0.2 - 0.3 mm less than a width of an adjacent portion of the strut.

[0142] Example 6. The prosthetic heart valve of any example herein, particularly any one of examples 1-5, wherein a width of the thinned strut portion is 0.05 - 0.15 mm.

[0143] Example 7. The prosthetic heart valve of any example herein, particularly any one of examples 1-6, wherein a width of the thinned strut portion is constant along a length of the thinned strut portion.

[0144] Example 8. The prosthetic heart valve of any example herein, particularly any one of examples 1-7, wherein the frame is expandable between an expanded configuration and an overexpanded configuration, wherein an inner diameter of the frame is greater in the overexpanded configuration than in the expanded configuration.

[0145] Example 9. The prosthetic heart valve of any example herein, particularly example 8, wherein adjacent struts of the first row of struts form an angle in the range of 120 degrees to 140 degrees in the expanded configuration.

[0146] Example 10. The prosthetic heart valve of any example herein, particularly either example 8 or example 9, wherein adjacent struts of the first row of struts form an angle in the range of 160 degrees to 180 degrees in the overexpanded configuration.

[0147] Example 11. The prosthetic heart valve of any example herein, particularly any one of examples 8-10, wherein the thinned strut portion is plastically expanded in the overexpanded configuration.

[0148] Example 12. The prosthetic heart valve of any example herein, particularly any one of examples 8-11, wherein the thinned strut portions have a first length in the expanded configuration and a second length that is longer than the first length in the overexpanded configuration.

[0149] Example 13. The prosthetic heart valve of any example herein, particularly any one of examples 8-12, wherein the frame is configured to break at one or more of the thinned strut portions in the overexpanded configuration.

[0150] Example 14. The prosthetic heart valve of any example herein, particularly any one of examples 1-13, wherein the frame includes a plurality of apex regions at the outflow end and the inflow end of the frame, wherein each apex region includes a thinned strut portion.

[0151] Example 15. A prosthetic heart valve comprising: a radially expandable and compressible annular frame comprising a plurality of interconnected angled struts defining a plurality of circumferentially extending rows of cells arranged between an outflow end andan inflow end of the frame, wherein the frame is expandable between an expanded configuration and an overexpanded configuration; wherein the plurality of interconnected angled struts is arranged to form a plurality of circumferentially extending rows of struts, wherein first struts of a first row of struts include a thinned strut portion that is spaced apart from ends of the first struts, wherein the thinned strut portion has a first length in the expanded configuration, wherein the thinned strut portion has a second length in the overexpanded configuration that is longer than the first length.

[0152] Example 16. The prosthetic heart valve of any example herein, particularly example 15, wherein an inner diameter of the frame is greater in the overexpanded configuration than in the expanded configuration.

[0153] Example 17. The prosthetic heart valve of any example herein, particularly either example 15 or example 16, wherein the thinned strut region is plastically expanded in the overexpanded configuration.

[0154] Example 18. The prosthetic heart valve of any example herein, particularly any one of examples 15-17, wherein an angle between adjacent first struts is between about 160 degrees and about 180 degrees in the overexpanded configuration.

[0155] Example 19. The prosthetic heart valve of any example herein, particularly any one of examples 15-18, wherein the first row of struts defines the outflow end of the frame.

[0156] Example 20. The prosthetic heart valve of any example herein, particularly any one of examples 15-19, wherein second struts of a second row of struts include a thinned strut portion that is spaced apart from ends of the second struts.

[0157] Example 21. The prosthetic heart valve of any example herein, particularly example 20, wherein the second row of struts is an intermediate row of struts positioned between the inflow end of the frame and the outflow end of the frame.

[0158] Example 22. The prosthetic heart valve of any example herein, particularly example 20, wherein the second row of struts defines the inflow end of the frame.

[0159] Example 23. The prosthetic heart valve of any example herein, particularly any one of examples 15-22, wherein each strut of the plurality of interconnected angled struts includes a thinned strut portion that is spaced apart from ends of the angled struts.

[0160] Example 24. The prosthetic heart valve of any example herein, particularly any one of examples 15-23, wherein the thinned strut portions have a first length in the expanded configuration and a second length that is longer than the first length in the overexpanded configuration.

[0161] Example 25. The prosthetic heart valve of any example herein, particularly any one of examples 15-24, wherein the frame is configured to break at one or more of the thinned strut portions in the overexpanded configuration.

[0162] Example 26. The prosthetic heart valve of any example herein, particularly any one of examples 15-25, wherein the frame includes a plurality of apex regions at the outflow end and the inflow end of the frame, wherein each apex region includes a thinned strut portion.

[0163] Example 27. A prosthetic heart valve comprising: a radially expandable and compressible annular frame comprising a plurality of interconnected angled struts defining a plurality of circumferentially extending rows of cells arranged between a first end and a second end of the frame; and a plurality of leaflets disposed within the frame and secured together at their adjacent sides to form commissures; wherein the plurality of interconnected angled struts is arranged to form a plurality of circumferentially extending rows of struts, including a first row of angled struts at the first end of the frame, one or more intermediate rows of angled struts, and a second row of angled struts at the second end of the frame, the one or more intermediate rows of angled struts disposed between the first row of angled struts and the second row of angled struts; wherein struts of the first row of struts include a first portion, a second portion, and an intermediate region between the first portion and the second portion, wherein a width of the first portion is greater than a width of the intermediate region, and wherein a width of the second portion is greater than a width of the intermediate region.

[0164] Example 28. The prosthetic heart valve of any example herein, particularly example 27, wherein the intermediate region is positioned at a midpoint of the strut.

[0165] Example 29. The prosthetic heart valve of any example herein, particularly either example 27 or example 28, wherein the width of the first portion is the same as the width of the second portion.

[0166] Example 30. The prosthetic heart valve of any example herein, particularly any one of examples 27-29, wherein an apex region extends between second portions of adjacentstruts of the first row of angled struts, wherein a width of the apex region is smaller than the width of the second portion.

[0167] Example 31. The prosthetic heart valve of any example herein, particularly any one of examples 27-30, wherein the width of the intermediate region is 0.2 - 0.3 mm less than the width of the first portion.

[0168] Example 32. The prosthetic heart valve of any example herein, particularly any one of examples 27-31, wherein the width of the intermediate region is 0.2 - 0.3 mm less than the width of the second portion.

[0169] Example 33. The prosthetic heart valve of any example herein, particularly any one of examples 27-32, wherein the width of the intermediate region is 0.05 - 0.15 mm.

[0170] Example 34. The prosthetic heart valve of any example herein, particularly any one of examples 27-33, wherein struts of the second row of struts include a first portion, a second portion, and an intermediate region between the first portion and the second portion, wherein a width of the first portion is greater than a width of the intermediate region, and wherein a width of the second portion is greater than a width of the intermediate region.

[0171] Example 35. The prosthetic heart valve of any example herein, particularly example 34, wherein the intermediate region of the struts of the second row of struts is positioned at a midway point of the strut.

[0172] Example 36. The prosthetic heart valve of any example herein, particularly any one of examples 27-35, wherein struts of the one or more intermediate rows of struts include a first portion, a second portion, and an intermediate region between the first portion and the second portion, wherein a width of the first portion is greater than a width of the intermediate region, and wherein a width of the second portion is greater than a width of the intermediate region.

[0173] Example 37. The prosthetic heart valve of any example herein, particularly example 36, wherein the intermediate region of the struts of the one or more intermediate rows of struts is positioned at a midway point of the strut.

[0174] Example 38. The prosthetic heart valve of any example herein, particularly any one of examples 27-37, wherein adjacent struts of the first row of struts form a first angle,wherein adjacent struts of the one or more rows of intermediate struts form a second angle, wherein the first angle is greater than the second angle.

[0175] Example 39. The prosthetic heart valve of any example herein, particularly any one of examples 27-38, wherein the frame is radially expandable between an expanded configuration and an overexpanded configuration, wherein adjacent struts of the first row of struts form a first angle between about 160 degrees and about 180 degrees in the overexpanded configuration.

[0176] Example 40. The prosthetic heart valve of any example herein, particularly example 39, wherein the intermediate region has a first length in the expanded configuration and a second length that is longer than the first length in the overexpanded configuration.

[0177] Example 41. The prosthetic heart valve of any example herein, particularly either example 39 or example 40, wherein the frame is configured to break at one or more of the intermediate regions in the overexpanded configuration.

[0178] Example 42. A prosthetic heart valve comprising: a radially expandable and compressible annular frame comprising a plurality of interconnected angled struts defining a plurality of circumferentially extending rows of cells arranged between a first end and a second end of the frame; and a plurality of leaflets disposed within the frame and secured together at their adjacent sides to form commissures; wherein the plurality of interconnected angled struts is arranged to form a plurality of circumferentially extending rows of struts, including a first row of angled struts at the first end of the frame, one or more intermediate rows of angled struts, and a second row of angled struts at the second end of the frame, the one or more intermediate rows of angled struts disposed between the first row of angled struts and the second row of angled struts; wherein adjacent struts of the first row of angled struts form a first angle, wherein adjacent struts of the one or more intermediate rows of angled struts form a second angle that is smaller than the first angle, wherein each strut of the first row of angled struts includes a thinned strut portion located at an intermediate region of the strut.

[0179] Example 43. The prosthetic heart valve of any example herein, particularly example 42, wherein the thinned strut portion is located at a midpoint of the strut.

[0180] Example 44. The prosthetic heart valve of any example herein, particularly either example 42 or example 43, wherein the first end of the frame is an outflow end of the frame.

[0181] Example 45. The prosthetic heart valve of any example herein, particularly any one of examples 42-44, wherein at least one strut of the second row of angled struts includes a thinned strut portion.

[0182] Example 46. The prosthetic heart valve of any example herein, particularly any one of examples 42-45, wherein a width of the thinned strut portion is 0.2 - 0.3 mm less than a width of an adjacent portion of the strut.

[0183] Example 47. The prosthetic heart valve of any example herein, particularly any one of examples 42-46, wherein a width of the thinned strut portion is 0.05 - 0.15 mm.

[0184] Example 48. The prosthetic heart valve of any example herein, particularly any one of examples 42-47, wherein a width of the thinned strut portion is constant along a length of the thinned strut portion.

[0185] Example 49. The prosthetic heart valve of any example herein, particularly any one of examples 42-48, wherein the frame is expandable between an expanded configuration and an overexpanded configuration, wherein an inner diameter of the frame is greater in the overexpanded configuration than in the expanded configuration.

[0186] Example 50. The prosthetic heart valve of any example herein, particularly example 49, wherein adjacent struts of the first row of struts form an angle in the range of 120 degrees to 140 degrees in the expanded configuration.

[0187] Example 51. The prosthetic heart valve of any example herein, particularly either example 49 or example 50, wherein adjacent struts of the first row of struts form an angle in the range of 160 degrees to 180 degrees in the overexpanded configuration.

[0188] Example 52. The prosthetic heart valve of any example herein, particularly any one of examples 49-51, wherein the thinned strut portions are plastically expanded in the overexpanded configuration.

[0189] Example 53. The prosthetic heart valve of any example herein, particularly any one of examples 49-52, wherein the thinned strut portions have a first length in the expandedconfiguration and a second length that is longer than the first length in the overexpanded configuration.

[0190] Example 54. The prosthetic heart valve of any example herein, particularly any one of examples 49-53, wherein the frame is configured to break at one or more of the thinned strut portions in the overexpanded configuration.

[0191] Example 55. The prosthetic heart valve of any example herein, particularly any one of examples 42-54, wherein the frame includes a plurality of apex regions at the first end and the second end of the frame, wherein each apex region includes a thinned strut portion.

[0192] Example 56. A method comprising: advancing a balloon of a delivery apparatus through a patient’s vasculature to a previously implanted prosthetic heart valve; and inflating the balloon of the delivery apparatus to overexpand the previously implanted prosthetic heart valve such that thinned strut regions of the previously implanted prosthetic heart valve plastically expand.

[0193] Example 57. The method of any example herein, particularly example 56, wherein advancing the balloon through the patient’s vasculatures comprises advancing the balloon having a subsequently implanted prosthetic heart valve coupled thereto through the patient’ s vasculature; and wherein inflating the balloon comprises inflating the balloon of the delivery apparatus to expand the subsequently implanted prosthetic heart valve within the previously implanted prosthetic heart valve.

[0194] Example 58. The method of any example herein, particularly either example 56 or example 57, wherein inflating the balloon comprises breaking one or more of the thinned strut regions of the previously implanted prosthetic heart valve.

[0195] Example 59. The method of any example herein, particularly any one of examples 56-58, wherein advancing a balloon of a delivery apparatus comprises advancing a balloon having a band disposed around a distal end portion of the balloon; and wherein inflating the balloon comprises inflating the balloon to a first diameter at a location adjacent to the band and a second diameter at the band, wherein the first diameter is greater than the second diameter.

[0196] Example 60. A method comprising: advancing a guest prosthetic heart valve on a balloon of a delivery apparatus through a patient’s vasculature to a host prosthetic heartvalve; and inflating the balloon of the delivery apparatus to expand the guest prosthetic heart valve against an inner surface of the host prosthetic heart valve such that a portion of a frame of the guest prosthetic heart valve flares radially outwards relative to a frame of the host prosthetic heart valve.

[0197] Example 61. The method of any example herein, particularly example 60, further comprising aligning the guest prosthetic heart valve with the host prosthetic heart valve, such that an inflow end of the frame of the guest prosthetic heart valve extends beyond an inflow end of the frame of the host prosthetic heart valve and an outflow end of the frame of the guest prosthetic heart valve extends beyond an outflow end of the frame of the host prosthetic heart valve.

[0198] Example 62. The method of any example herein, particularly example 61, wherein inflating the balloon of the delivery apparatus comprises inflating the balloon of the delivery apparatus to expand the guest prosthetic heart valve against the host prosthetic heart valve such that the inflow end of the frame of the guest prosthetic heart valve and the outflow end of the frame of the guest prosthetic heart valve extend at least partially around the inflow and outflow ends of the frame of the host prosthetic heart valve.

[0199] Example 63. The method of any example herein, particularly any one of examples 60-62, wherein inflating the balloon of the delivery apparatus comprises inflating the balloon of the delivery apparatus to overexpand the host prosthetic heart valve such that struts at an inflow end and at an outflow end of the frame of the host prosthetic heart valve assume a flattened configuration.

[0200] Example 64. A method comprising: advancing a guest prosthetic heart valve on a delivery apparatus through a patient’s vasculature to a host prosthetic heart valve; aligning an axial midpoint of the guest prosthetic heart valve with an axial midpoint of the host prosthetic heart valve; and expanding the guest prosthetic heart valve against the host prosthetic heart valve such that a frame of the guest prosthetic heart valve assumes a non-cylindrical configuration and a frame of the host prosthetic heart valve assumes an overexpanded configuration.

[0201] Example 65. The method of any example herein, particularly example 64, wherein aligning an axial midpoint of the guest prosthetic heart valve with an axial midpoint of the host prosthetic heart valve comprises positioning an inflow end of the frame of the guestprosthetic heart valve to extend beyond an inflow end of the frame of the host prosthetic heart valve and an outflow end of the frame of the guest prosthetic heart valve to extend beyond an outflow end of the frame of the host prosthetic heart valve.

[0202] Example 66. The method of any example herein, particularly either example 64 or example 65, wherein inflating the balloon of the delivery apparatus comprises inflating the balloon of the delivery apparatus to overexpand the host prosthetic heart valve such that struts at an inflow end and at an outflow end of the frame of the host prosthetic heart valve assume a flattened configuration.

[0203] Example 67. A method of implanting a guest valve within a host valve, the method comprising: advancing a guest prosthetic heart valve on a delivery apparatus through a patient’s vasculature to a host prosthetic heart valve; overexpanding the host prosthetic heart valve such that struts at an inflow end and an outflow end of a frame of the host prosthetic heart valve assume a flattened configuration; and expanding the guest prosthetic heart valve within the host prosthetic valve such that struts at an inflow end and an outflow end of a frame of the guest prosthetic heart valve bend radially outwards towards the host prosthetic heart valve.

[0204] Example 68. The method of any example herein, particularly example 67, wherein expanding the guest prosthetic heart valve within the host prosthetic valve comprises expanding the guest prosthetic heart valve such that the struts at the inflow and outflow ends of the frame of the guest prosthetic heart valve extend partially around the struts at the inflow and outflow ends of the frame of the host prosthetic heart valve.

[0205] Example 69. The method of any example herein, particularly either example 67 or example 68, further comprising positioning the guest prosthetic heart valve relative to the host prosthetic heart valve prior to expanding the guest prosthetic heart valve, such that the inflow end of the frame of the guest prosthetic heart valve extends beyond the inflow end of the frame of the host prosthetic heart valve and the outflow end of the frame of the guest prosthetic heart valve extends beyond the outflow end of the frame of the host prosthetic heart valve.

[0206] Example 70. The method of any example herein, particularly example 69, wherein positioning the guest prosthetic heart valve relative to the host prosthetic heart valvecomprises aligning an axial midpoint of the guest prosthetic heart valve with an axial midpoint of the host prosthetic heart valve.

[0207] Example 71. A prosthetic heart valve for deployment within a host valve, the prosthetic heart valve comprising: a radially expandable and compressible annular frame comprising a plurality of interconnected angled struts, the frame having an inflow end and an outflow end, wherein the angled struts form a plurality of apices at the inflow end and the outflow end; and a valvular structure disposed within the frame, wherein when prosthetic heart valve is implanted within a host valve, the apices are capable of flaring outwards relative to the host valve.

[0208] Example 72. The prosthetic heart valve of any example herein, particularly example 71, wherein when prosthetic heart valve is implanted within the host valve, the apices are capable of bending at least partially around ends of the host valve.

[0209] Example 73. The prosthetic heart valve of any example herein, particularly either example 71 or example 72, wherein when prosthetic heart valve is implanted within the host valve, the frame is capable of assuming a non-cylindrical configuration.

[0210] Example 74. The prosthetic heart valve of any example herein, wherein the valve is sterilized.

[0211] Example 75. A method comprising sterilizing the prosthetic heart valve of any example herein.

[0212] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one frame can be combined with any one or more features of another frame. As another example, any one or more features of one prosthetic heart valve can be combined with any one or more features of another prosthetic heart valve.

[0213] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

Claims:

1. A prosthetic heart valve comprising: a radially expandable and compressible annular frame comprising a plurality of interconnected angled struts; wherein the plurality of interconnected angled struts is arranged to form a plurality of circumferentially extending rows of struts, including a first row of angled struts, and wherein an intermediate region of at least one of the struts of the first row includes a thinned strut portion.

2. The prosthetic heart valve of claim 1 , wherein the thinned strut portion is located at a midpoint of the strut.

3. The prosthetic heart valve of either claim 1 or claim 2, wherein the first row of angled struts defines an outflow end of the frame.

4. The prosthetic heart valve of claim 3, wherein the first row of angled struts includes a plurality of apex regions interconnecting adjacent ends of adjacent angled struts and the thinned strut portion is located along one of the angled struts intermediate a respective apex region and a junction between the angled strut and an axial strut of the frame.

5. The prosthetic heart valve of claim 4, wherein all of the angled struts of the first row of angled struts have respective thinned strut portions.

6. The prosthetic heart valve of any one of claims 4-5, wherein only the angled struts of the first row of angled struts have thinned strut portions.

7. The prosthetic heart valve of any one of claims 4-6, wherein each apex region includes a thinned strut portion.

8. The prosthetic heart valve of any one of claims 1-7, wherein a width of the thinned strut portion is constant along a length of the thinned strut portion.

9. The prosthetic heart valve of any one of claims 1-8, wherein the frame is expandable between an expanded configuration and an overexpanded configuration, andwherein an inner diameter of the frame is greater in the overexpanded configuration than in the expanded configuration.

10. The prosthetic heart valve of claim 9, wherein adjacent struts of the first row of struts form an angle in a range of 160 degrees to 180 degrees in the overexpanded configuration.1 1 . The prosthetic heart valve of any one of claims 9-10, wherein the thinned strut portion is plastically expanded in the overexpanded configuration.

12. The prosthetic heart valve of any one of claims 9-11, wherein the thinned strut portions have a first length in the expanded configuration and a second length that is longer than the first length in the overexpanded configuration.

13. The prosthetic heart valve of any one of claims 1-12, wherein the frame is configured to break at one or more of the thinned strut portions in the overexpanded configuration.

14. A method comprising: advancing a balloon of a delivery apparatus through a patient’s vasculature to a previously implanted prosthetic heart valve; and inflating the balloon of the delivery apparatus to overexpand the previously implanted prosthetic heart valve such that one or more thinned strut regions of the previously implanted prosthetic heart valve plastically expand.

15. The method of claim 14, wherein advancing the balloon through the patient’s vasculature comprises advancing the balloon having a replacement prosthetic heart valve coupled thereto through the patient’s vasculature; and wherein inflating the balloon comprises inflating the balloon of the delivery apparatus to expand the replacement prosthetic heart valve within the previously implanted prosthetic heart valve.

16. The method of either claim 14 or claim 15, wherein inflating the balloon comprises breaking one or more of the thinned strut regions of the previously implanted prosthetic heart valve.

17. The method of any one of claims 14-16, wherein advancing the balloon of the delivery apparatus comprises advancing a balloon having a band disposed around a distal end portion of the balloon, wherein inflating the balloon comprises inflating the balloon to a first diameter at a location adjacent to the band and a second diameter at the band, and wherein the first diameter is greater than the second diameter.

18. A prosthetic heart valve for deployment within a host valve, the prosthetic heart valve comprising: a radially expandable and compressible annular frame comprising a plurality of interconnected angled struts, the frame having an inflow end and an outflow end, wherein the angled struts form a plurality of apices at the inflow end and the outflow end; and a valvular structure disposed within the frame, wherein when prosthetic heart valve is implanted within a host valve, the apices are capable of flaring outwards relative to the host valve.

19. The prosthetic heart valve of claim 18, wherein when prosthetic heart valve is implanted within the host valve, the apices are capable of bending at least partially around ends of the host valve.

20. The prosthetic heart valve of either claim 18 or claim 19, wherein when prosthetic heart valve is implanted within the host valve, the frame is capable of assuming a non-cylindrical configuration.

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