Prosthetic heart valve

Abstract

A prosthetic valve can include a radially compressible and expandable frame including a first plurality of struts and a circumferential cutout, an outer skirt disposed around the frame and covering the cutout, and a reinforcement member extending across or disposed within the cutout and blocking the outer skirt from moving inwardly through the cutout. The reinforcement member can include at least one of a reinforcement band and a subframe with a second plurality of struts. The frame can comprise and / or be formed from a first material having a first rigidity. The reinforcement member can comprise and / or be formed from a second material having a second rigidity less than the first rigidity. The circumferential cutout can be aligned with a feature of a subject's cardiac conduction system to further reduce the risk of conduction system disturbances.

Description

PROSTHETIC HEART VALVECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 727,317, filed on December 3, 2024, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to 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.

[0004] In some examples, a prosthetic heart valve can be implanted in a subject’s native aortic annulus. The native aortic annulus can be located near features of the subject’s cardiac conduction system, such as a membrane septum and a left bundle branch.SUMMARY

[0005] Described herein are prosthetic heart valves and methods for implanting prosthetic heart valves. The disclosed prosthetic heart valves and methods can, for example, reduce interference between an implanted prosthetic heart valve and a subject’s cardiac conduction system and / or overcome one or more deficiencies of typical prosthetic heart valves and their delivery apparatus.

[0006] A prosthetic valve can include an annular frame that is radially compressible and expandable.

[0007] In some examples, the annular frame can include a cutout in a circumferential portion thereof.

[0008] In some examples, the frame can include a first plurality of struts comprising and / or formed from a first material having a first rigidity.

[0009] In some examples, the prosthetic valve can include a valvular structure disposed within the frame for regulating the flow of blood through the frame in one direction.

[0010] In some examples, the prosthetic valve can include an outer skirt disposed around an outer surface of the frame.

[0011] In some examples, the outer skirt can cover the cutout.

[0012] In some examples, the prosthetic valve can include a reinforcement member.

[0013] In some examples, the reinforcement member can extend across the cutout.

[0014] In some examples, the reinforcement member can be disposed within the cutout.

[0015] In some examples, the reinforcement member can contact the outer skirt.

[0016] In some examples, the reinforcement member can block the outer skirt from moving inwardly through the cutout.

[0017] In some examples, the reinforcement member can comprise and / or be formed from a second material having a second rigidity less than the first rigidity.

[0018] In some examples, the reinforcement member can include at least one reinforcement band.

[0019] In some examples, the at least one reinforcement band can include a PET monofilament.

[0020] In some examples, the at least one reinforcement band can extend around an entire circumference of the frame.

[0021] In some examples, the at least one reinforcement band can include a plurality of axially spaced apart reinforcement bands.

[0022] In some examples, the reinforcement member can include a subframe comprising a second plurality of struts.

[0023] In some examples, each one of the first plurality of stmts and each one of the second plurality of stmts can have the same width and the same thickness.

[0024] In some examples, the second material can be Nitinol.

[0025] In some examples, the second material can be PET.

[0026] In some examples, the second material can be non-conductive.

[0027] In some examples, a method of fabricating a prosthetic heart valve can include forming a circumferential cutout of an annular frame.

[0028] In some examples, the method can include coupling a reinforcement member to the annular frame at a location of the circumferential cutout

[0029] In some examples, the method can include coupling an outer skirt to the annular frame.

[0030] In some examples, forming the annular frame can include removing a number of adjacent stmts from another annular frame.

[0031] In some examples, a prosthetic valve can include an annular frame that is radially compressible and expandable, a valvular structure disposed within the frame for regulating the flow of blood through the frame in one direction, an outer skirt disposed around an outer surface of the frame and covering a cutout, and a reinforcement member extending across or disposed within the cutout and contacting the outer skirt. The frame can include a first plurality of stmts comprising and / or formed from a first material having a first rigidity and a cutout in a circumferential portion of the annular frame. The reinforcement member can include at least one of at least one reinforcement band and a subframe comprising a second plurality of stmts. The reinforcement member can comprise and / or be formed from a second material having a second rigidity less than the first rigidity. The reinforcement member can block the outer skirt from moving inwardly through the cutout.

[0032] In some examples, a prosthetic heart valve can include a frame with a circumferential cutout, a skirt disposed around the frame, wherein the skirt is configured to cover the circumferential cutout, and at least one reinforcement band disposed around the frame and aligned in an axial direction with the circumferential cutout.

[0033] In some examples, a prosthetic valve can include an annular frame comprising and / or formed from a first material, wherein the annular frame can include a gap in a circumferential portion thereof, a filament disposed around the annular frame and at least partially covering the gap, wherein the filament can comprise and / or be formed from a second material that is relatively more flexible than the first material, and an outer skirt covering the gap and the filament.

[0034] In some examples, a prosthetic heart valve can include a frame and a skirt disposed around the frame. The frame can include a first circumferential portion comprising and / or formed from a first plurality of stmts and a second circumferential portion comprising and / or formed from a second plurality of stmts, wherein the first plurality of stmts can comprise and / or be formed from a first material having a first stiffness, the second plurality of stmts cancomprise and / or be formed from a second material having a second stiffness, and the first stiffness can be greater than the second stiffness.

[0035] In some examples, a method of fabricating a prosthetic heart valve can include forming a circumferential cutout of an annular frame, coupling a reinforcement member to the annular frame at a location of the circumferential cutout, and coupling an outer skirt to the annular frame. The annular frame can include a plurality of struts comprising and / or formed from a first material that can have a first rigidity. The reinforcement member can comprise and / or be formed from a second material having a second rigidity less than the first rigidity.

[0036] In some examples, a method can include advancing a prosthetic valve through a subject’s vasculature. The prosthetic valve can include a radially compressible and expandable annular frame with a first plurality of struts comprising and / or formed from a first material having a first rigidity and a cutout in a circumferential portion of the annular frame, a valvular structure disposed within the frame for regulating the flow of blood through the frame in one direction, an outer skirt disposed around an outer surface of the frame and covering the cutout, and a reinforcement member extending across or disposed within the cutout and contacting the outer skirt. The reinforcement member can include at least one of at least one reinforcement band and a subframe with a second plurality of struts, the reinforcement member can comprise and / or be formed from a second material having a second rigidity less than the first rigidity, and the reinforcement member can block the outer skirt from moving inwardly through the cutout. The method can further include aligning the cutout of the prosthetic valve with a feature of the subject’s cardiac conduction system and radially expanding the prosthetic valve within a native heart valve annulus such that the cutout is adjacent the feature of the subject’s cardiac conduction system.

[0037] In some examples, a prosthetic heart valve or a method of fabricating a prosthetic heart can include one or more of the features recited in Examples 1-53 below.

[0038] The above method(s) can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.

[0039] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0040] FIG. 1 is a side view of a prosthetic heart valve, according to an example.

[0041] FIG. 2 is a perspective view of the prosthetic heart valve of FIG. 1 with a valvular structure removed for clarity.

[0042] FIG. 3 is a side view of a frame of the prosthetic heart valve of FIG. 1.

[0043] FIG. 4 is a side view of a portion of the prosthetic heart valve of FIG. 1.

[0044] FIG. 5 is a schematic view of the prosthetic heart valve of FIG. 2 implanted in a native aortic annulus of a subject’s heart.

[0045] FIG. 6 is a side view of a portion a prosthetic heart valve, according to an example.

[0046] FIG. 7 is a side view of a prosthetic heart valve delivery apparatus, according to an example.DETAILED DESCRIPTIONGeneral Considerations

[0047] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be constmed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0048] 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 inconjunction 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.

[0049] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps not expressly referenced. Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. It is further noted that the claims can be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.

[0050] The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any aspect described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects. Unless specifically stated otherwise, the term “some” refers to one or more.

[0051] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the subject’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the subject’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined. The term “circumferential” refers to a direction following a circumference of a device.

[0052] Reference throughout this specification to “an implementation” means that a particular feature, structure, or characteristic described in connection with the implementation is included in at least one implementation. Thus, appearances of the phrases “in an implementation” invarious places throughout this specification are not necessarily all referring to the same implementation or a single exclusive implementation. Furthermore, the particular features, structures, or characteristics described herein may be combined in any suitable manner in one or more implementations.

[0053] It will be understood that the benefits and advantages described above can relate to one implementation or can relate to several implementations. Aspects described in connection with one implementation are intended to be able to be used with the other implementation. Any explanation in connection with one implementation applies to similar features of the other implementations, and elements of multiple implementations can be combined to form other implementations. The implementations are not limited to those that solve any or all of the stated problems or those that have any or all of the stated benefits and advantages

[0054] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”Overview of the Disclosed Technology

[0055] A native annulus of an aortic valve can be located in close proximity to various features of a cardiac conduction system within a subject’s heart. Exemplary features of the subject’s cardiac conduction system include a membrane septum and a left bundle branch.

[0056] When a prosthetic heart valve is implanted into the subject’s native aortic annulus, it can be desirable to minimize the amount of pressure exerted on the subject’s cardiac conduction system by the implanted prosthetic valve. In this way, the likelihood of conduction system disturbances (for example, left branch bundle block) can be minimized, thereby also minimizing a need to implant a pacemaker to address such disturbances. Thus, a need exists for a prosthetic heart valve that exerts minimal pressure on features the subject’s cardiac conduction system.

[0057] Disclosed herein are various examples of an improved prosthetic heart valve. The prosthetic heart valve can comprise a circumferential portion that is relatively more flexible (in other words, less rigid or stiff) than a remainder of the prosthetic heart valve. The relatively flexible circumferential portion can be aligned with a feature of the subject’s cardiac conduction system to further reduce the amount of mechanical pressure applied to the subject’s cardiac conduction system. In this way, the prosthetic heart valve can further reduce the risk of conduction system disturbances.Examples of the Disclosed Technology

[0058] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed stateduring delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0059] FIG. 1 is a side view of a prosthetic heart valve 100, according to an example. Any of the prosthetic valves disclosed herein are and / or can be adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a subject. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0060] 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.

[0061] The prosthetic heart valve 100 can include a frame 110, a valvular structure 120, an inner skirt 130 (as best shown in FIG. 2), and an outer skirt 140. The prosthetic heart valve 100 can define a central longitudinal axis 102 extending from an inflow end portion 104 to an outflow end portion 106 of the prosthetic heart valve 100.

[0062] The frame 110 can be a radially compressible and expandable structure having an annular shape. The frame 110 can define an inflow end portion 112 (FIG. 3) and an outflow end portion 114. The frame 110 can comprise a plurality of struts 116. The plurality of struts 116 can be arranged in a plurality of circumferentially -extending rows in a zig-zag pattern.Thus, as shown, each one of the plurality of struts 116 can be angled relative to the central longitudinal axis 102 of the prosthetic heart valve 100. As further shown, portions (e.g., the ends) of adjacent ones of the plurality of struts 116 can be joined to form a plurality of closed cells 118.

[0063] Although different ones of the plurality of struts 116 can have different lengths, in some examples, each one of the plurality of stmts 116 can have the same circumferential width. Additionally or alternatively, each one of the plurality of stmts 116 can have the same radial thickness.

[0064] The frame 110 can be made of any of various suitable materials (e.g., plastically- expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol)) as known in the art. When constmcted of a plastically-expandable material, the frame 110 (and thus the valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a subject by an inflatable balloon or equivalent expansion mechanism. When constmcted of a self-expandable material, the frame 110 (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 prosthetic heart valve 100 can be advanced from the delivery sheath, which allows the prosthetic heart valve 100 to expand to its functional size.

[0065] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 110) 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 110 can comprise stainless steel. In some examples, the frame 110 can comprise cobalt-chromium. In some examples, the frame 110 can comprise nickel-cobalt-chromium. In some examples, the frame 110 can comprise 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.

[0066] The valvular structure 120 can comprise three leaflets 122, collectively forming a leaflet stmcture, which can be arranged to collapse in a tricuspid arrangement, although in other examples there can be greater or fewer number of leaflets (for example, one or more leaflets 122). The leaflets 122 can be secured to one another at their adjacent sides to form commissures 124 of the valvular stmcture 120. A lower edge of valvular stmcture 120 can have an undulating, curved scalloped shape and can be secured to the inner skirt 130 by sutures(not shown). In some examples, the leaflets 122 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. 6,730,1 18, which is incorporated by reference herein in its entirety.

[0067] The inner skirt 130, which is best seen in FIG. 2, in some examples, can be configured to provide circumferential sealing of the frame 110, thereby preventing blood from flowing in a radially inwards direction through the frame 110. As shown, the inner skirt 130 can be disposed over and / or coupled to at least a portion of an inner surface of the frame 110. In some examples, the cusp (inflow) edges of the leaflets 122 can be stitched to the inner skirt 130 with one or more sutures, and the inner skirt 130 in turn can be secured to the struts of the frame 110 with one or more sutures.

[0068] The outer skirt 140 can be configured to provide sealing between the frame 110 and the subject’s native anatomy (for example, the walls of the native aortic annulus), thereby preventing paravalvular leakage. As shown, the outer skirt 140 can be disposed around and / or coupled to at least a portion of an outer surface of the frame 110.

[0069] At least one of the inner skirt 130 and the outer skirt 140 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the inner skirt 130 and / or the outer skirt 140 can comprise a fabric having interlaced yams or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the inner skirt 130 and / or the outer skirt 140 can comprise a fabric without interlaced yarns or fibers or randomly interlaced yams or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yams or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the inner skirt 130 and / or the outer skirt 140 can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)). etc. In some examples, the inner skirt 130 and / or the outer skirt 140 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the inner skirt 130 and / or the outer skirt 140 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0070] FIG. 2 is a perspective view of the prosthetic heart valve 100 with the valvular structure 120 removed for clarity. Thus, FIG. 2 illustrates the frame 110, the inner skirt 130, and the outer skirt 140 of the prosthetic heart valve 100.

[0071] Further details regarding the leaflets 122, the inner skirt 130, the outer skirt 140, the attachment of the leaflets 122 to the frame 110 and the inner skirt 130, the attachment of the inner skirt 130 to the frame 110, and the attachment of the outer skirt 140 to the frame 110 can be found in U.S. Publication Nos. 2018 / 0028310, 2023 / 0028375, and 2023 / 0355383, which are incorporated by reference herein in their entireties.

[0072] As shown, a circumferential portion of the frame 110 can be removed to form a circumferential cutout 150 (which is also referred to herein as a “gap,” an “opening,” and / or a “slot”), which in the illustrated example of FIG. 2 is devoid of any metal frame components. Since the circumferential portion of the frame 110 having the cutout 150 has no struts 116, the circumferential portion of the prosthetic heart valve 100 along the cutout 150 can be relatively more flexible (in other words, less rigid or stiff) than the remaining circumferential portions of the prosthetic valve. In some examples, in which the removed portion of the frame 110 would otherwise contact or exert pressure on a feature of the subject’s cardiac conductive system (for example, the membrane septum, the left bundle branch, etc.), aligning the cutout 150 and / or this relatively more flexible portion of the frame 110 with the feature of the subject’s cardiac conductive system can help reduce the likelihood that implanting the frame 110 and / or the prosthetic heart valve 100 results in a conduction system disturbance. Thus, a circumferential portion 108 of the prosthetic heart valve 100 that is provided with this cutout 150 can be relatively more flexible than other circumferential portions of the prosthetic heart valve 100. Although the presently illustrated frame 110 is shown with one cutout 150, some examples of the frame 110 can include multiple cutouts.

[0073] As shown, the cutout 150 is formed at the inflow end portion 112 of the frame 110. In some examples, the cutout 150 can be formed at the outflow end portion 114 of the frame 110. In some examples, the cutout 150 can be formed at an intermediate portion of the frame 110 axially between the inflow end portion 112 and the outflow end portion 114.

[0074] The cutout 150 can have a circumferential width (a width measured in a circumferential direction of the frame) equal to a portion of the circumference of the annular frame 110. Thus, the cutout 150 can be provided on only a circumferential portion of the frame 110. As shown, the cutout 150 extends partially along the length of the frame 110, for example, from an inflow end towards an outflow end of the frame 110. The cutout 150 can be sized to accommodate atleast a portion of a feature of a cardiac conductive system (for example, the membrane septum, the left bundle branch, etc.).

[0075] In some examples, the frame 110 (and more specifically, the cutout 150 of the frame 110) can be formed by removing a number of the plurality of struts 116 from a radially symmetric frame. For example, eight of the plurality of struts 116 can be removed to form the presently illustrated cutout 150. However, a greater (e.g., at least 8, at least 10, at least 12, at least 14, at least 16) or fewer number (e.g., between 1-7, between 1-5, between 1-3) of the plurality of struts 116 can be removed to form cutouts of different sizes or shapes. Adjacent ones of the plurality of struts 116 can be removed to form the cutout 150. In some examples, non- adjacent ones of the plurality of struts 116 can be removed to form a plurality of cutouts. Removal of the struts 116 results in one or more discontinuous rows of struts and / or cells 118 along the portion of the frame 1 10 containing the cutout. For example, in FIG. 2, the frame 110 has two discontinuous rows of struts 116 and one discontinuous row of cells 118 along the inflow end portion 112 of the frame 110. The number and location of discontinuous rows of struts 116 and cells 118 can vary depending on the size and location of the cutout 150 on the frame 110.

[0076] In some examples, the frame 1 10 can be formed by cutting (for example, laser cutting) a tube to form the plurality of stmts 116. In some examples, the cutout 150 can be formed by cutting a portion of a tube before the plurality of stmts 116 are formed. In some examples, a maximum width of the cutout 150 in a circumferential direction of the frame is about 10% to 30% of the total circumference of the frame, and in some examples, about 15% to 20% of the total circumference of the frame, and about 16% of the total circumference of the frame in a specific example. In some examples, the height of the cutout 150 (measured in a direction from the inflow end to the outflow end of the frame) is about 20% to 60% of the total height of the frame, and in some examples, about 30% to 50% of the total height of the frame, and in some examples, about 35% to 45% of the total height of the frame.

[0077] FIG. 3 is a side view of the frame 110 that further illustrates the cutout 150.

[0078] Referring back to FIG. 2, the outer skirt 140 is shown to cover the cutout 150. In some examples, the prosthetic heart valve 100 can comprise a reinforcement member or a support member configured to prevent ingress of the outer skirt 140 through the cutout 150 and into the frame 110. For example, the prosthetic heart valve 100 can further comprise at least one reinforcement band 160 (which is also referred to herein as a “band,” a “filament,” and / or a “reinforcement filament”) configured to prevent the outer skirt 140 from collapsing in the radially inwards direction through the cutout 150. Additionally, the at least one reinforcementband 160 can be configured to be relatively more flexible than the portion of the frame 110 that was removed to form the cutout 150. Thus, when the at least one reinforcement band 160 is placed into direct or indirect contact with the subject’s cardiac conduction system, the at least one reinforcement band 160 can be configured to exert relatively less pressure or force on the subject’s cardiac conduction system than the portion of the frame 110 that was removed to form the cutout 150.

[0079] FIG. 4 is a side view of a portion of the prosthetic heart valve 100, wherein the illustrated portion consists of the frame 1 10 and the at least one reinforcement band 160. As shown, the at least one reinforcement band 160 can comprise a plurality of reinforcement bands 160 that are spaced apart from each other in the axial direction, for example, starting at the inflow end portion 112 of the frame 110. The reinforcement bands 160 can be evenly or unevenly spaced apart from each other in the axial direction. The at least one reinforcement band 160 can extend partially or entirely around the frame 110, for example, around the inflow end portion 112 of the frame 110. The at least one reinforcement band 160 can be placed over the cutout 150, for example, to partially cover or occlude the cutout 150.

[0080] In some examples, the at least one reinforcement band 160 can be disposed radially between the frame 1 10 and the outer skirt 140. In some examples, the at least one reinforcement band 160 can be introduced into the outer skirt 140, for example, by weaving the at least one reinforcement band 160 into the yarns or threads forming the outer skirt 140.

[0081] In some examples, the at least one reinforcement band 160 can be coupled to (for example, sutured to, fastened to, and / or adhered to) the frame 110. In some examples, the at least one reinforcement band 160 can be coupled to (for example, sutured to, fastened to, adhered to, and / or woven into) the outer skirt 140.

[0082] In some examples, the at least one reinforcement band 160 can comprise at least one filament or monofilament (for example, a PET monofilament). For example, the at least one reinforcement band 160 can comprise a monofilament having a thickness greater or equal to 0.008 inches.

[0083] The at least one reinforcement band 160 can comprise and / or be formed from a “semirigid” material, in that the material forming the reinforcement band 160 is relatively less rigid (in other words, more flexible or less stiff) than the relatively more rigid material forming the plurality of struts 116 of the frame 110. For example, the frame 110 can comprise and / or be formed from a first material comprising any combination of cobalt-chromium, a nickel-cobalt- chromium alloy, and a nickel-cobalt-chromium-molybdenum alloy. The at least one reinforcement band can comprise and / or be formed from a second material comprising Nitinol,a polymer (for example, PET), or any combination thereof. In some examples, where the first material is Nitinol, the second material can be a polymer such as PET. In this way, the at least one reinforcement band 160 can be configured to be sufficiently rigid in order to prevent the outer skirt 140 from collapsing in the radially inwards direction through the cutout 150, yet sufficiently flexible in order to minimize the pressure exerted on the features of the subject's cardiac conductive system. In some examples, the struts 116 of the frame 110 and the at least one reinforcement band 160 can be made of the same material, but the at least one reinforcement band 160 can be relatively more flexible than the stmts 1 16 by virtue of the reinforcement band 160 being thinner than the struts 116. For example, the at least one reinforcement band 160 can be a metal wire (for example, made of Nitinol or any of the cobaltchromium alloys disclosed above) and the frame 110 can be made of the same or a different metal.

[0084] In some examples, the reinforcement band 160 can comprise and / or be formed from a non-conductive material (for example, PET or any of various other suitable polymers) to further reduce the likelihood that direct or indirect contact between the reinforcement band 160 and the subject’s cardiac conduction system results in conduction disturbances.

[0085] In some examples, the outer skirt 140 can comprise and / or be formed from a third material that is relatively less rigid than each one of the first material forming the frame 110 and the second material forming the at least one reinforcement band 160.

[0086] FIG. 5 is a schematic view of the prosthetic heart valve 100 implanted in a native aortic annulus 20 of a heart 10 of a subject (e.g., a living subject, a simulation, etc.). The heart 10 comprises an aortic valve and a cardiac conduction system 30. The cardiac conduction system 30 can comprise various features, including a membrane septum 40 and a bundle of His 50. The bundle of His 50 can include a left bundle branch 60, a right bundle branch 70, a penetrating bundle 80, and a atrioventricular node 90.

[0087] When the prosthetic heart valve 100 is implanted at the native aortic annulus 20, a portion of the prosthetic heart valve 100 (for example, the inflow end portion 104) can contact and / or exert pressure on one or more features of the cardiac conduction system 30. For example, the inflow end portion 104 of the implanted prosthetic heart valve 100 is shown in contact with the membrane septum 40.

[0088] As shown, the prosthetic heart valve 100 is implanted at the native aortic annulus 20 such that the circumferential portion 108 of the prosthetic heart valve 100 provided with the cutout 150 is circumferentially aligned with the membrane septum 40. Since the cutout 150 renders this circumferential portion 108 relatively more flexible than other circumferentialportions of the prosthetic heart valve 100, this circumferential portion 108 can beneficially exert less pressure or force on the membrane septum 40 than the other circumferential portions of the prosthetic heart valve 100. In this way, the design of the prosthetic heart valve 100 can further reduce the likelihood that contact between the prosthetic heart valve 100 and the cardiac conduction system 30 will result in a conduction system disturbance. Furthermore, the design of the prosthetic heart valve 100 can reduce the likelihood that the subject will require a subsequent medical procedure (for example, the implantation of a pacemaker) to address such a conduction system disturbance.

[0089] FIG. 6 is a side view of a portion of a prosthetic heart valve 200, according to an example. The prosthetic heart valve 200 can comprise the frame 110, the valvular structure 120, the inner skirt 130, and the outer skirt 140. The valvular structure 120, the inner skirt 130, and the outer skirt 140 have been removed for clarity.

[0090] One exemplary difference between the prosthetic heart valve 200 and the previously illustrated prosthetic heart valve 100 is that the prosthetic heart valve 200 can include a subframe 260 in lieu of the reinforcement band 160. The subframe 260 can be configured to prevent the outer skirt 140 from collapsing in a radially inwards direction through the cutout 150. The subframe 260 can be a reinforcement and / or a support member for the outer skirt 140 configured to at least partially cover or occlude the cutout 150 and / or be placed in the cutout 150, thereby blocking ingress of the outer skirt 140. Thus, in some examples, the subframe 260 can be referred to as a “reinforcement subframe’’.

[0091] The subframe 260 can comprise a plurality of angled struts 262 joined to form one or more open cells 264. For example, as shown, the subframe 260 comprises eight angled stmts 262 joined to form two open cells 264. Each one of the plurality of stmts 262 can have a width in a circumferential direction and a thickness in a radial direction. In some examples, each one of the plurality of stmts 262 has the same width and thickness as each one of the plurality of stmts 116 forming the frame 110. In some examples, in which the cutout 150 is formed by removing a number of the plurality of stmts 116 and cells 118, the subframe 260 can have the same number of stmts 262 and cells 264 arranged in the pattern as those removed to form the cutout 150. For example, if eight stmts 116 and two cells 118 are removed to form the cutout 150, the subframe 260 can include eight stmts 262 and two cells 264 arranged in the same pattern. The cells 264 can have the same size and shape as the cells 118a in the first row of cells 118 at the inflow end portion 112 of the frame. Thus, the cells 118a and the cells 264 form a continuous row 270 of cells at the inflow end portion of the frame. In this way, theframe 110 (including the subframe 260) can have a substantially uniform, substantially radially symmetric geometry.

[0092] In some examples, the subframe 260 can be considered one portion or segment of a larger frame assembly that includes both the frame 110 and the subframe 260.

[0093] In some examples, the subframe 260 can be more flexible than frame 110.

[0094] In some examples, the subframe 260 can comprise and / or be formed from a different material than the frame 110. For example, the plurality of struts 116 of the frame 110 can comprise and / or be formed from a first material. The plurality of struts 262 of the subframe 260 can comprise and / or be formed from a second material that is relatively less rigid (in other words, more flexible or less stiff) than the first material. For example, the subframe 260 can comprise and / or be formed from any material described above for forming the reinforcement band 160, such as any of various polymers, metals, or combinations thereof. In this way, the subframe 260 can be configured to be sufficiently rigid in order to prevent the outer skirt 140 from collapsing in the radially inwards direction through the cutout 150, yet sufficiently flexible in order to minimize the pressure exerted on the features of the subject’s cardiac conductive system. In some examples, the subframe 260 can be of an elastomeric material, such as natural rubber or any of various synthetic elastomers.

[0095] In some examples, the subframe 260 can be made of a metal that is different than or the same as the metal that forms the frame 110. For example, the subframe 260 can be made of Nitinol, while the frame 110 can be made of a cobalt-chromium alloy, stainless steel, or another metal. In some examples, the subframe 260 can be made of Nitinol having a transition temperature greater than body temperature so that the subframe 260 can remain in the martensitic phase when implanted and therefore can be relatively pliable and ductile to avoid applying undue force against the heart’s conduction system. In examples where the subframe 260 is made of the same material as the frame 110, the subframe 260 can be more flexible than the frame 110, for example, by forming the struts 262 to have a width and / or thickness that is less than the width and / or thickness of the struts 116. In some examples where the subframe 260 is made of the same material as the frame 110, the subframe 260 and the frame 110 can be made from a single piece of the material. In some of these examples, the portion of the single piece of material defining the subframe 260 can be configured to be more flexible than the portion of the single piece of material defining the frame 110 by forming the struts 262 of the portion defining the subframe 260 to have a width and / or thickness that is less than the width and / or thickness of the struts 116 of the portion defining the frame 110.

[0096] In some examples, the subframe 260 can comprise and / or be formed from a non- conductive material (for example, a polymer) to further reduce the likelihood that direct or indirect contact between the subframe 260 and the subject’s cardiac conduction system results in conduction disturbances.

[0097] In some examples, since the frame 110 and the subframe 260 are coupled together and constructed from struts having similar geometries, the frame 110 and the subframe 260 can be considered different portions or segments of a larger overall frame assembly.

[0098] The subframe 260 can be coupled to the frame 1 10 (for example, to certain ones of the plurality of struts 116 and / or junctions disposed at the intersections of adjacent struts 116) using various techniques and / or connectors. As shown, the subframe 260 can be connected to the frame 110 using sutures 266. Each suture 266 can be wrapped around a pair of adjacent junctions of the subframe 260 and the frame 110. In some examples, the subframe 260 can be coupled to the frame 110 using at least one mechanical fastener, such as a clasp, clip, rivet, screw, pin, etc. In some examples, the subframe 260 can be adhered or welded to the frame 110.

[0099] Further details of the prosthetic heart valves 100 and 200, their components, and their variants are described in PCT Publication No. WO 2021 / 202636, which is incorporated by reference herein in its entirety.

[0100] FIG. 7 shows a delivery apparatus 300, according to an example, which can be used to implant an expandable prosthetic heart valve (e.g., the prosthetic heart valve 100 of FIG. 1 and / or any of the other prosthetic heart valves described herein). In some examples, the delivery apparatus 300 is specifically adapted for use in introducing a prosthetic valve into a heart.

[0101] The delivery apparatus 300 in the illustrated example of FIG. 7 is a balloon catheter comprising a handle 302 and a steerable, outer shaft 304 extending distally from the handle 302. The delivery apparatus 300 can further comprise an intermediate shaft 306 (which also may be referred to as a balloon shaft) that extends proximally from the handle 302 and distally from the handle 302, the portion extending distally from the handle 302 also extending coaxially through the outer shaft 304. Additionally, the delivery apparatus 300 can further comprise an inner shaft 308 extending distally from the handle 302 coaxially through the intermediate shaft 306 and the outer shaft 304 and proximally from the handle 302 coaxially through the intermediate shaft 306.

[0102] The outer shaft 304 and the intermediate shaft 306 can be configured to translate (e.g., move) longitudinally, along a central longitudinal axis 320 of the delivery apparatus 300,relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a subject’s body.

[0103] The intermediate shaft 306 can include a proximal end portion 310 that extends proximally from a proximal end of the handle 302, to an adaptor 312. A rotatable knob 314 can be mounted on the proximal end portion 310 and can be configured to rotate the intermediate shaft 306 around the central longitudinal axis 320 and relative to the outer shaft 304.

[0104] The adaptor 312 can include a first port 338 configured to receive a guidewire therethrough and a second port 340 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 340 can be fluidly coupled to an inner lumen of the intermediate shaft 306.

[0105] The intermediate shaft 306 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 304 when a distal end of the outer shaft 304 is positioned away from an inflatable balloon 318 of the delivery apparatus 300. A distal end portion of the inner shaft 308 can extend distally beyond the distal end portion of the intermediate shaft 306.

[0106] The balloon 318 can be coupled to the distal end portion of the intermediate shaft 306.

[0107] In some examples, a distal end of the balloon 318 can be coupled to a distal end of the delivery apparatus 300, such as to a nose cone 322 (as shown in FIG. 7), or to an alternate component at the distal end of the delivery apparatus 300 (e.g., a distal shoulder). An intermediate portion of the balloon 318 can overlay a valve mounting portion 324 of a distal end portion of the delivery apparatus 300 and a distal end portion of the balloon 318 can overly a distal shoulder 326 of the delivery apparatus 300. The valve mounting portion 324 and the intermediate portion of the balloon 318 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG. 7, a prosthetic heart valve 350 (which can be one of the prosthetic valves described herein) can be mounted around the balloon 318, at the valve mounting portion 324 of the delivery apparatus 300.

[0108] The balloon shoulder assembly, including the distal shoulder 326, is configured to maintain the prosthetic heart valve 350 (or other medical device) at a fixed position on the balloon 318 during delivery through the subject’s vasculature.

[0109] The outer shaft 304 can include a distal tip portion 328 mounted on its distal end. The outer shaft 304 and the intermediate shaft 306 can be translated axially relative to one another to position the distal tip portion 328 adjacent to a proximal end of the valve mounting portion 324, when the prosthetic valve 350 is mounted in the radially compressed state on the valve mounting portion 324 (as shown in FIG. 7) and during delivery of the prosthetic valve to thetarget implantation site. As such, the distal tip portion 328 can be configured to resist movement of the prosthetic valve 350 relative to the balloon 318 proximally, in the axial direction, relative to the balloon 318, when the distal tip portion 328 is arranged adjacent to a proximal side of the valve mounting portion 324.

[0110] An annular space can be defined between an outer surface of the inner shaft 308 and an inner surface of the intermediate shaft 306 and can be configured to receive fluid from a fluid source via the second port 340 of the adaptor 312. 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 308 and an inner surface of the balloon 318. As such, fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the balloon 318 and radially expand and deploy the prosthetic valve 350.

[0111] 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 300 to the target implantation site.

[0112] The handle 302 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 300. In the illustrated example, for example, the handle 302 includes an adjustment member, such as the illustrated rotatable knob 360, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 302 through the outer shaft 304 and has a distal end portion affixed to the outer shaft 304 at or near the distal end of the outer shaft 304. Rotating the knob 360 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 300. 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 in its entirety.

[0113] The handle 302 can further include an adjustment mechanism 361 including an adjustment member, such as the illustrated rotatable knob 362, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 378. The adjustment mechanism 361 is configured to adjust the axial position of the intermediate shaft 306 relative to the outer shaft 304 (e.g., for fine positioning at the implantation site). Further details on the delivery apparatus 300 can be found in PCT Publication No. WO2022 / 046585 which is incorporated by reference herein in its entirety.Example Delivery Techniques

[0114] 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 thedistal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (for example, by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0115] 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.

[0116] 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.

[0117] 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 anincision 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.

[0118] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a subject’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various deliver)' procedures and delivery devices known in the art.Sterilization

[0119] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation usable and / or for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals usable and / or for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.Simulation

[0120] 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.Additional Examples of the Disclosed Technology

[0121] 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.

[0122] Example 1. A prosthetic valve can include a radially compressible and expandable annular frame that can include a cutout in a circumferential portion of the annular frame, a valvular structure disposed within the frame for regulating the flow of blood through the frame in one direction, an outer skirt disposed around an outer surface of the frame and covering the cutout, and a reinforcement member extending across or disposed within the cutout and contacting the outer skirt. The frame can include a first plurality of stmts comprising and / or formed from a first material having a first rigidity. The reinforcement member can include at least one of at least one reinforcement band and a subframe comprising a second plurality of stmts. The reinforcement member can comprise and / or be formed from a second material having a second rigidity less than the first rigidity. The reinforcement member can block the outer skirt from moving inwardly through the cutout.

[0123] Example 2. The prosthetic valve of any example herein, particularly Example 1, wherein the outer skirt can comprise and / or be formed from a third material having a third rigidity less than each one of the first rigidity and the second rigidity.

[0124] Example 3. The prosthetic valve of any example herein, particularly any one of Examples 1-2, wherein the reinforcement member can include the at least one reinforcement band.

[0125] Example 4. The prosthetic valve of any example herein, particularly Example 3, wherein the at least one reinforcement band can be woven into the outer skirt.

[0126] Example 5. The prosthetic valve of any example herein, particularly any one of Examples 3-4, wherein the at least one reinforcement band can extend around an entire circumference of the frame.

[0127] Example 6. The prosthetic valve of any example herein, particularly any one of Examples 3-5, wherein the at least one reinforcement band can include a plurality of reinforcement bands.

[0128] Example 7. The prosthetic valve of any example herein, particularly Example 6, wherein the plurality of reinforcement bands can be spaced apart from each other in an axial direction of the frame.

[0129] Example 8. The prosthetic valve of any example herein, particularly any one of Examples 1-2, wherein the reinforcement member can include the subframe.

[0130] Example 9. The prosthetic valve of any example herein, particularly Example 8, wherein each one of the first plurality of stmts and each one of the second plurality of stmts can have the same width and the same thickness.

[0131] Example 10. The prosthetic valve of any example herein, particularly any one of Examples 8-9, wherein the second plurality of struts can include eight struts.

[0132] Example 1 1. The prosthetic valve of any example herein, particularly any one of Examples 8-10, wherein the second plurality of struts can be arranged to form two cells.

[0133] Example 12. The prosthetic valve of any example herein, particularly any one of Examples 8-11, wherein the subframe can be coupled to the annular frame using one or more mechanical fasteners.

[0134] Example 13. The prosthetic valve of any example herein, particularly any one of Examples 8-11, wherein the subframe can be coupled to the annular frame using one or more sutures.

[0135] Example 14. The prosthetic valve of any example herein, particularly any one of Examples 1-13, wherein the first material can be any combination of a cobalt -chromium alloy and stainless steel, and wherein the second material can be Nitinol.

[0136] Example 15. The prosthetic valve of any example herein, particularly any one of Examples 1-13, wherein the first material can be a metal and the second material can be PET.

[0137] Example 16. The prosthetic valve of any example herein, particularly any one of Examples 1-13, wherein the second material can be non-conductive.

[0138] Example 17. A prosthetic heart valve can include a frame with a circumferential cutout, a skirt disposed around the frame, wherein the skirt is configured to cover the circumferential cutout, at least one reinforcement band disposed around the frame and aligned in an axial direction with the circumferential cutout.

[0139] Example 18. The prosthetic heart valve of any example herein, particularly Example 17, wherein the circumferential cutout can be disposed at an inflow end portion of the frame.

[0140] Example 19. The prosthetic heart valve of any example herein, particularly any one of Examples 17-18, wherein the at least one reinforcement band can include a plurality of reinforcement bands.

[0141] Example 20. The prosthetic heart valve of any example herein, particularly Example19, wherein the plurality of reinforcement bands can be spaced apart in an axial direction of the prosthetic heart valve.

[0142] Example 21. The prosthetic heart valve of any example herein, particularly Example20, wherein the plurality of reinforcement bands can be evenly spaced apart in the axial direction.

[0143] Example 22. The prosthetic heart valve of any example herein, particularly any one of Examples 17-21, wherein the at least one reinforcement band can include at least one monofilament.

[0144] Example 23. The prosthetic heart valve of any example herein, particularly Example 22, wherein the at least one monofilament can have a thickness greater than or equal to 0.008 inches.

[0145] Example 24. The prosthetic heart valve of any example herein, particularly any one of Examples 17-23, wherein the frame can comprise and / or be formed from a first material having a first stiffness, and the reinforcement band can comprise and / or be formed from a second material having a second stiffness less than the first stiffness.

[0146] Example 25. The prosthetic heart valve of any example herein, particularly Example 24, wherein the second material can be Nitinol.

[0147] Example 26. The prosthetic heart valve of any example herein, particularly Example 24, wherein the second material can be PET.

[0148] Example 27. The prosthetic heart valve of any example herein, particularly Example 24, wherein the second material can be non-conductive.

[0149] Example 28. A prosthetic valve can include an annular frame comprising and / or formed from a first material, wherein the annular frame can include a gap in a circumferential portion thereof, a filament disposed around the annular frame and at least partially covering the gap, wherein the filament can comprise and / or be formed from a second material that is relatively more flexible than the first material, and an outer skirt covering the gap and the filament.

[0150] Example 29. The prosthetic valve of any example herein, particularly Example 28, wherein the second material can be a polymer.

[0151] Example 30. The prosthetic valve of any example herein, particularly Example 29, wherein the second material can be PET.

[0152] Example 31. The prosthetic valve of any example herein, particularly any one of Examples 28-30, wherein the outer skirt can comprise and / or be formed from a third material that is relatively more flexible than the second material.

[0153] Example 32. The prosthetic valve of any example herein, particularly any one of Examples 28-31, wherein the filament can be coupled to the outer skirt.

[0154] Example 33. The prosthetic valve of any example herein, particularly any one of Examples 28-32, wherein the filament can be disposed radially between the annular frame and the outer skirt.

[0155] Example 34. The prosthetic valve of any example herein, particularly any one of Examples 28-32, wherein the filament can be woven into the outer skirt.

[0156] Example 35. A prosthetic heart valve can include a frame and a skirt disposed around the frame. The frame can include a first circumferential portion comprising and / or formed from a first plurality of stmts and a second circumferential portion comprising and / or formed from a second plurality of stmts, wherein the first plurality of stmts can comprise and / or be formed from a first material having a first stiffness, the second plurality of stmts can comprise and / or be formed from a second material having a second stiffness, and the first stiffness can be greater than the second stiffness.

[0157] Example 36. The prosthetic heart valve of any example herein, particularly Example 35, wherein the first circumferential portion can be coupled to the second circumferential portion by at least one suture.

[0158] Example 37. The prosthetic heart valve of any example herein, particularly Example 35, wherein the first circumferential portion can be coupled to the second circumferential portion by at least one mechanical fastener.

[0159] Example 38. The prosthetic heart valve of any example herein, particularly any one of Examples 35-37, wherein the first material can be any combination of cobalt-chromium, a nickel-cobalt-chromium alloy, and a nickel-cobalt-chromium-molybdenum alloy.

[0160] Example 39. The prosthetic heart valve of any example herein, particularly Example 38, wherein the second material can be NitinoL

[0161] Example 40. The prosthetic heart valve of any example herein, particularly any one of Examples 35-37, wherein the first material can be NitinoL

[0162] Example 41. The prosthetic heart valve of any example herein, particularly Example40, wherein the second material can be a polymer.

[0163] Example 42. The prosthetic heart valve of any example herein, particularly Example41, wherein the second material can be PET.

[0164] Example 43. The prosthetic heart valve of any example herein, particularly any one of Examples 37-42, wherein each one of the first plurality of struts can have a width and a thickness, and each one of the second plurality of struts can have the same width and the same thickness as each one of the first plurality of struts.

[0165] Example 44. A method of fabricating a prosthetic heart valve can include forming a circumferential cutout of an annular frame, coupling a reinforcement member to the annular frame at a location of the circumferential cutout, and coupling an outer skirt to the annular frame. The annular frame can include a plurality of struts comprising and / or formed from afirst material that can have a first rigidity. The reinforcement member can comprise and / or be formed from a second material having a second rigidity less than the first rigidity.

[0166] Example 45. The method of any example herein, particularly Example 44, wherein the annular frame can be a second annular frame, the plurality of struts can be a second plurality of stmts, and forming the second annular frame can include: forming a first annular frame having a first plurality of struts, wherein a number of the first plurality of struts can be greater than a number of the second plurality of stmts, and removing a number of adjacent ones of the first plurality of stmts.

[0167] Example 46. The method of any example herein, particularly Example 45, wherein eight adjacent ones of the first plurality of stmts can be removed.

[0168] Example 47. The method of any example herein, particularly any one of Examples 45-46, wherein the number of adjacent ones of the first plurality of stmts can be removed from an inflow end portion of the first annular frame.

[0169] Example 48. The method of any example herein, particularly any one of Examples 44-47, wherein the reinforcement member can include at least one reinforcement band.

[0170] Example 49. The method of any example herein, particularly Example 48, wherein the at least one reinforcement band can include a PET monofilament.

[0171] Example 50. The method of any example herein, particularly any one of Examples 44-47, wherein the reinforcement member can include a subframe comprising a plurality of struts each having the same width and the same thickness as the plurality of struts of the annular frame.

[0172] Example 51. The method of claim 50, wherein coupling a reinforcement member to the annular frame at the location of the circumferential cutout can include: inserting the subframe at least partially into the circumferential cutout, and suturing the subframe to the annular frame.

[0173] Example 52. A method can include advancing a prosthetic valve through a subject’s vasculature. The prosthetic valve can include a radially compressible and expandable annular frame with a first plurality of struts comprising and / or formed from a first material having a first rigidity and a cutout in a circumferential portion of the annular frame, a valvular structure disposed within the frame for regulating the flow of blood through the frame in one direction, an outer skirt disposed around an outer surface of the frame and covering the cutout, and a reinforcement member extending across or disposed within the cutout and contacting the outer skirt. The reinforcement member can include at least one of at least one reinforcement band and a subframe with a second plurality of struts, the reinforcementmember can comprise and / or be formed from a second material having a second rigidity less than the first rigidity, and the reinforcement member can block the outer skirt from moving inwardly through the cutout. The method can further include aligning the cutout of the prosthetic valve with a feature of the subject’s cardiac conduction system and radially expanding the prosthetic valve within a native heart valve annulus such that the cutout is adjacent the feature of the subject’s cardiac conduction system.

[0174] Example 53. A prosthetic heart valve comprising: a frame having a main frame portion and a sub-frame portion, wherein the sub-frame portion is less rigid than the main frame portion.

[0175] Example 54. The prosthetic heart valve of any example herein, particularly of example 53, wherein the sub-frame portion comprises a set of generally parallel reinforcement bands and / or filaments and / or portions thereof.

[0176] Example 55. The prosthetic heart valve of example 54, wherein the set of generally parallel reinforcement bands and / or filaments and / or portions thereof extend circumferentially around at least a portion of the main frame portion.

[0177] Example 56. The prosthetic heart valve of any example herein, particularly any of examples 53-55, wherein a strut pattern of the sub-frame portion is the same as a strut pattern of the main frame portion.

[0178] Example 57. The prosthetic heart valve of any example herein, particularly any of examples 53-56, wherein the plurality of stmts are thinner and / or of a different material in the sub-frame portion relative to the main frame portion.

[0179] Example 58. The prosthetic heart valve of any example herein, particularly any of examples 53-57, wherein the sub-frame portion and the main frame portion are made of different materials.

[0180] Example 59. The prosthetic heart valve of any example herein, wherein the prosthetic heart valve is sterilized.

[0181] Thus, specific examples of prosthetic heart valves have been disclosed. The above description of the disclosed implementations is provided to enable any person skilled in the art to make or use the devices, systems and methods disclosed herein. The preceding detailed description illustrates examples and is not intended to limit the disclosure or the application and uses of the devices, systems and methods disclosed herein. Various modifications to these implementations will be readily apparent to those skilled in the art, and the general principles described herein can be applied to other implementations without departing from the spirit or scope of the disclosure. Thus, it is to be understood that the description anddrawings presented herein represent an implementation of the delivery apparatuses and are therefore representative of the subject matter which is broadly contemplated by the present application. It is further understood that the scope of the present application fully encompasses other implementations that may become obvious to those skilled in the art and that the scope of the present application is accordingly not limited.

[0182] 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 prosthetic heart valve can be combined with any one or more features of another prosthetic heart valve. As another example, any one or more features of one method can be combined with any one or more features of another method.

[0183] 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.

[0184] All structural and functional equivalents to the components of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

Claims

What Is Claimed Is:

1. A prosthetic heart valve comprising: a frame comprising a circumferential cutout; a skirt disposed around the frame, wherein the skirt is configured to cover the circumferential cutout; and at least one reinforcement band disposed around the frame and aligned in an axial direction with the circumferential cutout.

2. The prosthetic heart valve of claim 1, wherein the circumferential cutout is disposed at an inflow end portion of the frame.

3. The prosthetic heart valve of any one of claims 1-2, wherein the at least one reinforcement band comprises a plurality of reinforcement bands.

4. The prosthetic heart valve of claim 3, wherein the plurality of reinforcement bands are spaced apart in an axial direction of the prosthetic heart valve.

5. The prosthetic heart valve of any one of claims 1-4, wherein the at least one reinforcement band comprises at least one monofilament.

6. The prosthetic heart valve of any one of claims 1-5, wherein: the frame is formed from a first material having a first stiffness, and the reinforcement band is formed from a second material having a second stiffness less than the first stiffness.

7. The prosthetic heart valve of claim 6, wherein the second material is non- conductive.

8. The prosthetic valve of any one of claims 1-7, wherein the reinforcement band is disposed radially between the frame and the skirt.

9. The prosthetic valve of any one of claims 1-7, wherein the reinforcement band is woven into the skirt.

10. A prosthetic heart valve comprising: a frame comprising a first circumferential portion formed from a first plurality of struts and a second circumferential portion formed from a second plurality of struts, wherein: the first plurality of struts are formed from a first material having a first stiffness, the second plurality of struts are formed from a second material having a second stiffness, and the first stiffness is greater than the second stiffness; and a skirt disposed around the frame.

11. The prosthetic heart valve of claim 10, wherein the first material is any combination of cobalt-chromium, a nickel-cobalt-chromium alloy, and a nickel-cobalt- chromium-molybdenum alloy.

12. The prosthetic heart valve of claim 10, wherein the first material is NitinoL13. The prosthetic heart valve of any one of claims 10-12, wherein the second material is a polymer.

14. The prosthetic heart valve of any one of claims 10-13, wherein: each one of the first plurality of struts has a width and a thickness, and each one of the second plurality of struts has the same width and the same thickness as each one of the first plurality of struts.

15. A method of fabricating a prosthetic heart valve comprising: forming a circumferential cutout of an annular frame, wherein: the annular frame comprises a plurality of struts, and the plurality of struts are formed from a first material having a first rigidity: coupling a reinforcement member to the annular frame at a location of the circumferential cutout, wherein: the reinforcement member is formed from a second material having a second rigidity, and the second rigidity less than the first rigidity; andcoupling an outer skirt to the annular frame.

16. The method of claim 15, wherein: the annular frame is a second annular frame, the plurality of struts is a second plurality of struts, and forming the second annular frame comprises: forming a first annular frame having a first plurality of struts, wherein a number of the first plurality of stmts is greater than a number of the second plurality of stmts; and removing a number of adjacent ones of the first plurality of stmts.

17. The method any one of claims 15-16, wherein the number of adjacent ones of the first plurality of stmts are removed from an inflow end portion of the first annular frame.

18. The method of any one of claims 15-17, wherein the reinforcement member comprises at least one reinforcement band.

19. The method of any one of claims 15-17, wherein: the reinforcement member comprises a subframe comprising a plurality of stmts each having the same width and the same thickness as the plurality of stmts of the annular frame.

20. The method of claim 19, wherein coupling a reinforcement member to the annular frame at the location of the circumferential cutout comprises: inserting the subframe at least partially into the circumferential cutout; and suturing the subframe to the annular frame.

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