WO2025193686A1 - Prosthetic valve frame with radially offset commissure windows - Google Patents

Abstract

A radially collapsible and expandable prosthetic heart valve is disclosed. A frame of the prosthetic valve can have radially offset commissure windows. In some examples, a plurality of commissure window elements includes at least one support post and a commissure window frame disposed radially inward from the adjacent cells of the valve frame.

Description

PROSTHETIC VALVE FRAME WITH RADIALLY OFFSET COMMISSURE

WINDOWS

CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63/564,360, filed March 12, 2024, which is incorporated herein by reference.

FIELD

[0002] The present disclosure concerns examples of a prosthetic heart valve including frames for a prosthetic heart valve.

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, for example, provide improved center hole coaptation and decrease friction on valve leaflets. As such, the prosthetic valves disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves.

[0005] In some examples, a frame for a prosthetic heart valve, comprises: a central longitudinal axis extending from an inflow end of the frame to an outflow end of the frame; a plurality of interconnected struts defining a plurality of rows of cells, the plurality of rows arranged between the outflow end and the inflow end of the frame and including a first row of cells, wherein the plurality of interconnected struts includes a first row of struts and a second row of struts, wherein the first row of cells is at least partially defined by the first and second rows of struts; a plurality of commissure window elements, each comprising: a commissure window frame; a first support post which couples the commissure window frame to the first row of struts; and a second support post which couples the commissure window frame to the second row of struts; wherein each commissure window element is disposed adjacent to a cell of the first row of cells and wherein the first and second support posts extend radially inward from the first and second rows of struts such that the commissure window frames are disposed radially inward relative to the first row of cells.

[0006] In some examples, the frame defines a circumference and the commissure window elements of the plurality of commissure window elements are spaced equally around the circumference. In some examples, the plurality of commissure window elements comprises three commissure window elements.

[0007] In some examples, each commissure window frame is positioned radially inward at least 1 mm relative to the first row of cells. In some examples, the first support post is coupled to a peak formed by the first row of struts and the second support post is coupled to a peak formed by the second row of struts. In some examples, the first and second support posts extend radially inward at an angle of less than 45 degrees relative to a line which extends through the peak formed by the first row of struts and the peak formed by the second row of struts. In some examples, the commissure window frame is rectangular.

[0008] In some examples, a prosthetic heart valve, comprises: a frame comprising a plurality of interconnected struts arranged in a plurality of rows of struts defining a plurality of rows of cells; and a plurality of commissure supports coupled to respective first cells of one of the rows of cells, wherein the commissure supports are disposed radially inward relative to the first cells; a plurality of leaflets forming a plurality of commissures coupled to the commissure supports.

[0009] In some examples, each commissure support comprises a commissure window frame and first and second radially inwardly angled stmts that connect the window frame to a respective first cell. In some examples, the first radially inwardly angled stmt extends from a peak of a first row stmts of the plurality of rows of stmts and the second radially inwardly angled strut extends from a peak of a second row of struts of the plurality of rows of struts.

[0010] In some examples, each commissure support is disposed radially inward relative to an entirety of a remaining portion of the frame. In some examples, each commissure comprises an adjacent pair of commissure tabs of adjacent leaflets of the plurality of leaflets, wherein the commissure tabs extend through a window of a corresponding commissure support.

[0011] In some examples, a prosthetic heart valve, comprises: a frame comprising: a longitudinal axis extending from an inflow end of the frame to an outflow end of the frame; a plurality of interconnected struts defining a plurality of rows of cells, the plurality of rows arranged between the outflow end and the inflow end of the frame and including a first row of cells, wherein the plurality of interconnected struts comprises a first row of angled struts and a second row of angled struts, wherein the first row of cells is at least partially defined by the first and second rows of stmts; a plurality of commissure window elements, each comprising: a commissure window frame; at least one support post which couples the commissure window frame to the first row of stmts; and wherein the at least one support post extends inward towards the longitudinal axis such that each commissure window frame is disposed radially inward of the first row of cells; and a leaflet structure positioned within the frame and comprising a plurality of leaflets connected to each other at commissures, wherein each commissure is coupled to one of the plurality of commissure window frames.

[0012] In some examples, the prosthetic valve is radially compressible to a radially compressed state and radially expandable to an expanded state. In some examples, the prosthetic valve is configured to be deployed to a plurality of working diameters.

[0013] In some examples, each commissure comprises an adjacent pair of commissure tabs of adjacent leaflets of the plurality of leaflets, wherein the commissure tabs extend through a window of a corresponding window frame. [0014] In some examples, the at least one support post has a first end connected to the first row of struts and a second end connected to the window frame.

[0015] In some examples, the cells of the first row of cells are hexagonal. In some examples, the plurality of rows of cells defines a cylindrical main body of the frame. In some examples, the window frames are disposed radially inward of an entirety of the main body of the frame.

[0016] In some examples a prosthetic heart valve comprises: a frame comprising: a longitudinal axis extending from an inflow end of the frame to an outflow end of the frame; a plurality of interconnected struts comprising a first row of angled struts and a second row of angled struts, wherein a first row of cells of the frame is at least partially defined by the first and second rows of struts; a plurality of commissure window elements, each comprising: a commissure window frame; a first support post which couples the commissure window frame to the first row of struts; and wherein the first support post extends inward towards the longitudinal axis such that each commissure window frame is disposed radially inward of the first row of cells.

[0017] In some examples each commissure window element of the plurality of commissure window elements further comprises one or more adjustable support posts. In some examples, each of the adjustable support posts is coupled at a first end to the commissure window frame and coupled at a second end to the second row of angled struts. In some examples, each adjustable support post comprises an expansion section that can expand lengthwise of the adjustable support post when the frame is radially compressed.

[0018] In some examples, the prosthetic heart valve further comprises a leaflet structure positioned within the frame and comprising a plurality of leaflets connected to each other at commissures, wherein each commissure is coupled to one of the plurality of commissure window elements.

[0019] 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

[0020] FIG. 1 is a side view of a prosthetic heart valve, according to one example.

[0021] FIG. 2 is a side view of a delivery apparatus for a prosthetic heart valve, according to one example.

[0022] FIG. 3 is a flattened view of an exemplary frame for use in a prosthetic heart valve.

[0023] FIG. 4 is a schematic plan view of the frame of FIG. 3 as viewed from the outlet of the frame.

[0024] FIGS. 5-6 depict enlarged views of a single cell of the frame of FIG. 3 containing a commissure window element comprising a commissure window frame and two support posts.

[0025] FIG. 7 is a schematic cross-sectional view of a commissure window frame and a commissure coupled to the window frame, according to one example.

[0026] FIG. 8 depicts an enlarged view of a single cell of another example of a frame containing a commissure window element comprising a commissure window frame and one support post.

[0027] FIG. 9 is a perspective view of the frame of FIG. 8 for use in a prosthetic heart valve.

[0028] FIGS. 10A-10B depict schematic plan views of the frame of FIG. 8 as viewed from the outlet of the frame, first in an expanded state (FIG. 10A) and then in a crimped state (FIG. 10B).

[0029] FIG. 11 depicts an enlarged view of a single cell of another example of a frame containing a commissure window element comprising a commissure window frame, one support post, and two adjustable support posts.

DETAILED DESCRIPTION

General Considerations

[0030] 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 arc 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.

[0031] 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.

[0032] 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.

[0033] 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. [0034] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”

Examples of the Disclosed Technology

[0035] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state during 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.

[0036] FIG. 1 shows an exemplary prosthetic valve 100, according to one example. Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries, and vessels of a 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.

[0037] 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. [0038] The prosthetic valve 100 can comprise a frame 1 12, a valvular structure 114, an inner skirt 116, and a pcrivalvular outer scaling member or outer skirt 118. The prosthetic valve 100 can comprise an inflow end portion 115 and an outflow end portion 119, and an intermediate portion 117 extending therebetween.

[0039] The valvular structure 114 can comprise a plurality of leaflets 140 collectively forming a leaflet structure. In some examples, the valvular structure 114 can comprise three leaflets 140 arranged in a tricuspid arrangement. However, there can be a greater or fewer number of leaflets 140. The leaflets can be secured to one another at their adjacent sides to form commissures 122 of the valvular structure 114. The lower edge of the valvular structure 114 can have an undulating, curved scalloped shape, and can be secured to the inner skirt 116 by sutures (not shown). In some examples, the leaflets 140 can be formed of pericardial tissue (such as bovine pericardial tissue), biocompatible synthetic materials, or other various suitable natural or synthetic materials as known in the art and described in U.S. Patent Number 6,730,118, which is incorporated by reference herein.

[0040] The frame 112 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 112 (and thus the prosthetic valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable catheter balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 112 (and thus the prosthetic 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.

[0041] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 112) 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 112 can comprise stainless steel. In some examples, the frame 112 can comprise cobalt-chromium. In some examples, the frame 112 can comprise nickel-cobalt-chromium. In some examples, the frame 1 12 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™/UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0042] The inner skirt 116 and/or the outer skirt 118 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the skirts 116, 118 can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the skirts 116, 118 can comprise a fabric without interlaced yarns 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 skirts 116, 118 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 skirts 116, 118 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the skirts 116, 118 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

Delivery Apparatus

[0043] FIG. 2 shows a delivery apparatus 200, according to one example, in the form of a balloon catheter that can be used to implant a prosthetic medical device. In some examples, the delivery apparatus 200 can be used to implant an expandable prosthetic heart valve (for example, 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 200 is specifically adapted for use in introducing a prosthetic heart valve into a heart.

[0044] The delivery apparatus 200 in the illustrated example of FIG. 2 comprises 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.

[0045] 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 heart valve at an implantation site in a patient’s body.

[0046] 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.

[0047] The adaptor 212 can include a first port 238 configured to receive a guide wire 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.

[0048] 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 catheter balloon 218 (which also referred to herein as a “balloon”) 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.

[0049] The catheter balloon 218 can be coupled to the distal end portion of the intermediate shaft 206.

[0050] In some examples, a distal end of the catheter 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. 2), or to an alternate component at the distal end of the delivery apparatus 200 (for example, a distal shoulder). An intermediate portion of the catheter 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 catheter balloon 218 can overly a distal shoulder 226 of the delivery apparatus 200. The valve mounting portion 224 and the intermediate portion of the catheter balloon 218 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG. 2, a prosthetic heart valve 250 (which can be one of the prosthetic heart valves described herein) can be mounted around the catheter balloon 218, at the valve mounting portion 224 of the delivery apparatus 200.

[0051] The balloon shoulder assembly, including the distal shoulder 226, is configured to maintain the prosthetic heart valve 250 (or other prosthetic medical device) at a fixed position on the catheter balloon 218 during delivery through the patient’s vasculature.

[0052] 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 heart valve 250 is mounted in the radially compressed state on the valve mounting portion 224 (as shown in FIG. 2) and during delivery of the prosthetic heart valve to the target implantation site. As such, the distal tip portion 228 can be configured to resist movement of the prosthetic heart valve 250 relative to the catheter balloon 218 proximally, in the axial direction, relative to the catheter balloon 218, when the distal tip portion 228 is ar anged adjacent to a proximal side of the valve mounting portion 224.

[0053] 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 catheter balloon 218. As such, fluid from the fluid source can How to the fluid passageway from the annular space to inflate the catheter balloon 218 and radially expand and deploy the prosthetic heart valve 250.

[0054] 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.

[0055] 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.

[0056] 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.

Frame with Radially Inward Positioned Commissures

[0057] In some examples, a prosthetic heart valve is capable of being deployed to a working diameter within a range of possible working diameters. Such variable sizing has the advantage of customizing the size of the deployed prosthetic valve to the individual patient’s anatomy. To this end, it may be desirable for a deployed frame to have commissure windows which are positioned radially inward from adjacent portions of the frame. One advantage of such frame designs is that, when a prosthetic valve with variable sizing is deployed to the high end of the variable size range, the commissure windows deploy to a smaller diameter than the adjacent portions of the frame and therefore assists in achieving good center hole coaptation of the leaflets. Another advantage is that when the prosthetic valve is deployed to the low end of the variable size range, the leaflets are subject to less wear during the life of the prosthetic valve as the leaflets are less likely to contact the frame and/or the inner skirt during working cycles of the prosthetic valve.

[0058] FIGS. 3-6 are directed to a frame 312 comprising commissure windows which are positioned radially inward from adjacent portions of the frame. It should be understood that the frame 312 can be used with a prosthetic valve, such as prosthetic valve 100. For example, the frame 312 can be used in place of frame 112 (FIG. 1). It should be understood that the frame 312 can be formed from any of the same materials as described above with respect to the frame 112. Furthermore, in some examples, the prosthetic valve comprising the frame 312 can include one or more other components of the prosthetic valve 100, for example, a valvular’ structure 114, an inner skirt 116, and a perivalvular outer sealing member or outer skirt 118, etc. These components are described in detail above with regards to prosthetic valve 100 and should be understood to have the same composition and properties as are described above.

[0059] Referring to FIG. 3, the frame 312 has an inflow end portion 315 and an outflow end portion 319, and an intermediate portion 317 extending therebetween. In the below discussion, the term “lower” is used to describe elements which are closer to the inflow end portion 315 and the term “upper” is used to describe elements which are closer to the outflow end portion 319. These terms are used for ease of explanation and it should be understood that in practice the frame 312 can be oriented in any direction.

[0060] The frame 312 may comprise interconnected struts. In the illustrated example, the frame 312 comprises a first, lower row 1 of angled struts 322 arranged end-to-end and extending circumferentially at the inflow end of the frame; a second row II of circumferentially extending, angled struts 324; a third row III of circumferentially extending, angled struts 326; a fourth row IV of circumferentially extending, angled struts 328; and a fifth row V of circumferentially extending, angled stmts 332 at the outflow end of the frame. A plurality of substantially straight axially extending struts 334 can be used to interconnect the stmts 322 of the first row I with the struts 324 of the second row II. The fifth row V of angled stmts 332 are connected to the fourth row IV of angled struts 328 by a plurality of axially extending stmts 331. Each axial stmt 331 extends from a location defined by the convergence of the lower ends of two angled struts 332 to another location defined by the convergence of the upper ends of two angled stmts 328.

[0061] The struts of the frame collectively define a plurality of open cells of the frame. At the inflow end of the frame 312, stmts 322, stmts 324, and stmts 334 define a lower row of cells defining openings 336. The second, third, and fourth rows of struts 324, 326, and 328 define two intermediate rows of cells defining openings 338. The fourth and fifth rows of struts 328 and 332, along with struts 331, define an upper row (also referred to as a “first row”) of cells defining openings 339. The openings 339 are relatively large and are sized to allow portions of the valvular structure 114 to protrude, or bulge, into and/or through the openings 339 when the frame 312 is crimped in order to minimize the crimping profile. In some examples, the fourth row IV of angled struts 328; the fifth row V of angled struts 332, and the axial struts 331 form a row of cells which are hexagonal in shape at the outflow end portion 319. In some examples, the row of hexagonal cells may be elongated in the axial direction. In some examples, the hexagonal cells comprise upper peaks at location 332a and lower peaks at location 328a.

[0062] In some examples, there may be additional components disposed between the fifth row V of angled struts 332 and the fourth row IV of angled struts 328, such as a plurality of commissure window elements 320 (also referred to as “commissure supports”). In the depicted example there are three commissure window elements 320. Each commissure window element 320 comprises a commissure window frame 330 and support posts 342, 344. In the depicted example, each commissure window frame 330 is supported by an upper (also referred to as a “first”) support post 342 and a lower (also referred to as a “second”) support post 344. Each pair of first and second support posts 342, 344 couple a respective commissure frame 330 to a respective cell in the upper row of cells defined by the struts 328 and 332. For example, in the illustrated example, each upper support post 342 extends from a location defined by the convergence of the upper ends of two angled struts 332 to another location on the upper portion of the commissure window frame 330. Each lower support post 344 extends from a location defined by the convergence of the lower ends of two angled struts 328 to another location on the lower portion of the commissure window frame 330.

[0063] In the depicted example, the upper support post 342 is an adjustable support post and comprises an expansion section 343 which can elongate during crimping and shorten when the frame is expanded. In the depicted example, the adjustable support post is the upper support post 342 and the lower support post 344 is of a fixed length. In some examples, the lower support post 344 is an adjustable support post and the upper support post 342 is of a fixed length. In the depicted example, the expansion section 343 that has a zig zag shape, however in other examples the expansion section 343 can have another shape, such as an “S” or a “C” shape. As the frame is transitioned from the expanded state to the crimped state the cell elongates in the axial direction and the lower apex of the cell pulls the commissure window frame downwardly. The expansion section 343 accommodates movement of the window frame by elongating during crimping, and provides support for the upper end of the window frame.

[0064] Each commissure window frame 330 defines a commissure window 340 which can mount a respective commissure of the valvular structure (such as commissure 122 of valvular structure 114 as depicted in FIG. 1). As shown, each window frame 330 is secured at its upper end portion to the fifth row V of angled stmts 332 by the upper support post 342 and at its lower end portion to the fourth row IV of angled stmts 328 by the lower support post 344. As will be discussed below with respect to FIG. 6, in some examples, the upper support post 342 and the lower support post 344 are angled relative to a longitudinal axis 316 of the frame (FIG. 4) such that the commissure window frame 330 is disposed radially inward from the fifth row V of angled stmts 332 and the fourth row IV of angled stmts 328. As described above, the radially inward position of the commissure window frame 330 provides several advantages, for example, for variable size prosthetic valve frames.

[0065] FIG. 4 shows the frame 312 from the outlet point of view including the longitudinal axis 316 which extends into the page from the inflow end portion 315 to the outflow end portion 319 of the frame. In some examples, the frame 312 defines a circumference and the commissure window elements 320 are disposed such that they are equally spaced from each other in a circumferential direction. In the depicted example, there are three commissure window elements 320 which are equally spaced relative to the circumference of the frame 312. In the depicted example, each commissure window frame 330 is radially offset from an adjacent cell (for example, a cell of the upper row of cells) of the frame 312 such that the commissure window frames 330 are positioned radially inward from the adjacent row of cells of the frame 312 (that is, radially closer to the longitudinal axis 316). In some examples, the adjacent cells are cells of the upper row of cells which define openings 339 (FIG. 3). Relative to the longitudinal axis, the adjacent cells are disposed at a position defined by a first radius 314 and the commissure window frames 330 are disposed at a position defined by a second radius 318. The first radius 314 is larger than the second radius 318. In some examples, the difference between the first radius 314 and the second radius 318 is at least 1 mm. [0066] The rows of cells defined by the rows of struts 322, 324, 326, 328, 332 and the struts 334, 331 define a main body of the frame 312. In some examples, the main body is cylindrical and the window frames 330 are radially offset from an entirety of the main body of the frame.

[0067] FIGS. 5-6 depict enlarged views of a portion of the frame 312 comprising an upper cell and a commissure window element 320. In the depicted example, the commissure window frame 330 includes an enclosed opening or window 340 which is defined by an upper portion 330a, a lower portion 330b, and two axially extending side portions 330c, 330d (also referred to a side struts) of the commissure window frame portion 330. In some examples, the window 340 can be rectangular.

[0068] As described above, each upper support post 342 extends from a location 332a defined by the convergence of the upper ends of two angled struts 332 to another location on the upper portion 330a of the commissure window frame 330. In the depicted example, the upper support post 342 is an adjustable support post and comprises an expansion section 343 which can elongate during crimping and shorten when the frame is expanded as described in detail above. Each lower support post 344 extends from a location 328a defined by the convergence of the lower ends of two angled struts 328 to another location on the lower portion 330b of the commissure window frame 330. FIG. 6 is an enlarged, side view of a portion of the frame 312, depicting the commissure window frame 330. As can be seen, the upper support post 342 and the lower support post 344 extend radially away from the adjacent cell, and the opening 339, of the frame 312 (that is, closer to axis 316 as depicted in FIG. 4). In some examples, the angle formed between a straight line that intersects locations 332a, 328a and either of the support posts 342, 344 is greater than 0 degrees and less than 90 degrees. In some examples, the angle is greater than 0 and less than 45 degrees.

[0069] FIG. 7 is a schematic cross-sectional view of a commissure window frame 330 illustrating a commissure 122 coupled to the window frame 330. As shown, the commissure 122 comprises a pair of commissure tabs 350a, 350b of adjacent leaflets 140a, 140b. The commissure tabs 350a, 350b extend radially through the window 340. The commissure tab 350a can wrap partially around the outside of the side portion 330c and the commissure tab 350b can wrap at least partially around the outside of the side portion 330d. The commissure tabs 350a, 350b can secured to the side portions 330c, 330d with sutures and/or fabric reinforcing members, as known in the art. Further details regarding the connection of commissures to commissure window frames arc disclosed in U.S. Patent No. 9,393,110, which is incorporated herein by reference.

[0070] In some examples, the commissure supports 320 need not include window frames 330 defining windows 340 that receive a pair of commissure tabs of adjacent leaflets. In any of the examples disclosed herein, the commissure supports 320 can have any structure configured to support a commissure of a leaflet assembly. For example, the window frame 330 in any of the disclosed examples can be replaced with a commissure support portion in the form of a support post or strut that has openings or eyelets that receive sutures for stitching a commissure to the support post or strut, such as disclosed in U.S. Patent No. 7,993,394, which is incorporated herein by reference. Thus, in some examples, a commissure support 320 can comprise a commissure support portion and one or more support posts for connecting the commissure support 320 to a cell of the frame. The commissure supports 320 can incorporate various other structures or shapes for securing commissures to the frame, such as any of those disclosed in U.S. Patent No. 7,510,575, which is incorporated herein by reference.

[0071] FIG. 8 depicts an enlarged, side view of a portion of a frame 312’ comprising an upper cell and a commissure window element 320’. The frame 312’ should be understood to have the same characteristics as the frame 312 except for those described below. The commissure window element 320’ comprises the commissure window frame 330 and a single support post. In this manner, the window frame 330 is cantilevered. In the depicted example, the single support post is the lower support post 344. Since the upper support post 342 is removed in this example, the upper portion 330a of the window frame 330 is a free end. In some examples, the single support post can be the upper support post 342. In the depicted example, the commissure window frame 330 includes the enclosed opening or window 340 which includes the lower portion 330b. The lower support post 344 extends from the location 328a defined by the convergence of the lower ends of two angled struts 328 to another location on the lower portion 330b of the commissure window frame 330.

[0072] FIG. 9 depicts a frame 312’ having a plurality of commissure window elements 320’ and shown in an expanded state. In some examples, the frame 312’ is the same as the frame 312 except for the exclusion of the upper support posts 342. As can be seen, each lower support post 344 extends radially inwardly and away from the adjacent cell, and the opening 339, of the frame 312 (that is, closer to axis 316 as depicted in FIG. 10A). In some examples, the angle formed between a straight line that intersects locations 332a, 328a and the support post 344 is greater than 0 degrees and less than 90 degrees. In some examples, the angle is greater than 0 and less than 45 degrees.

[0073] FIGS. 10A-10B depict schematic plan views of the frame 312’ as viewed from the outlet of the frame, first in an expanded state (FIG. 10A) and in a compressed state (FIG. 10B) (the process of transitioning from the expanded state to the compressed state may also be referred to as “crimping”). FIGS. 10A-10B include the longitudinal axis 316 of the frame which extends into the page from the inflow end portion 315 to the outflow end portion 319 of the frame. In some examples, the frame 312’ defines a circumference and the commissure window elements 320’ are disposed such that they are equally spaced from each other in a circumferential direction. In the depicted example, there are three commissure window elements 320’ which are equally spaced relative to the circumference of the frame 312’. In the depicted example, each commissure window frame 330 is radially offset from an adjacent cell (for example, a cell of the upper row of cells) of the frame 312’ such that the commissure window frames 330 are positioned radially inward from the adjacent row of cells of the frame 312’ (that is, radially closer to the longitudinal axis 316). In some examples, the adjacent cells are cells of the upper row of cells which define openings 339. In some examples, the commissure window frames are positioned radially inward at least 1 mm from the adjacent row of cells.

[0074] During crimping, as the frame 312’ transitions from an expanded state (FIG. 10A) to a compressed state (FIG. 10B), the cells (such as the cells defining openings 336, 338, and 339) elongate in the axial direction. The frame 312’ with the commissure window element 320’, which comprises only single support post, allows the cells to axially elongate during crimping with less interference from the commissure window element. As the frame 312’ is radially compressed, the commissure window elements 320’ can remain radially offset toward the longitudinal axis 316.

[0075] FIG. 11 depicts an enlarged, side view of a portion of a frame 312” comprising an upper cell and a commissure window element 320”. The frame 312” should be understood to have the same characteristics as the frame 312’ except for those described below. The commissure window element 320” comprises a fixed length support post, the commissure window frame 330 and one or more adjustable support posts 346. In some examples, the one or more adjustable support posts 346 can elongate during crimping and shorten when the frame is expanded. In the depicted example, the fixed length support post is the lower support post 344 and there are two adjustable support posts 346, each of which is coupled at one end to the upper portion of a respective, adjacent axially extending strut 331 and at the other end to the upper portion 330a of the commissure window frame 330. In the depicted example, each of the adjustable support posts 346 comprises an expansion section 348 that has a zig zag shape, however in other examples the expansion section 348 can have another shape, such as an “S” or a “C” shape. As the frame is transitioned from the expanded state (for example, the expanded state as depicted in FIG. 10A) to the crimped state (for example, the crimped state as depicted in FIG. 10B) the cell elongates in the axial direction and the lower apex of the cell pulls the commissure window frame downwardly. The expansion sections 348 accommodate movement of the window frame by elongating during crimping, and provide support for the upper end of the window frame. In some examples, the upper cell of frame 312” does not include angled struts 332. In some examples, the upper cell can include the angled struts 332 (shown in dashed lines in FIG. 11). In some examples, the fixed length support post can be the upper support post 342 and one or more adjustable support posts can be coupled at one end to the lower portion of a respective, adjacent axially extending strut 331 and at the other end to the lower portion 330b of the commissure window frame 330.

[0076] In some examples, the frame 312”, or at least the support posts 346, are made of a shape-memory material, such Nitinol. In such examples, the support posts 346 can be shape set in the foreshortened state (as shown in FIG. 11) and can elongate during crimping of the prosthetic valve. When the prosthetic valve is expanded (such as when released from a delivery sheath), the support posts 346 can revert to the foreshortened state under their own resiliency.

[0077] As described above, it may be desirable that the commissure windows 340 be deployed to a different radial location than the adjacent cells (for example, a cell of the upper row of cells) of any of the frames described herein, for example the frame 312. This design has advantages for frames which can be deployed at a variety of different sizes. One advantage is that when the prosthetic valve is deployed to high end of the variable size range, the commissure windows are deployed to a smaller diameter than the adjacent cells of the frame and therefore assist achieving good center hole coaptation of the leaflets. Another advantage is that, when the prosthetic valve is deployed to low end of the variable size range smaller diameter, the moving portions of the leaflets, especially the coaptation edges (the outflow edges), are subject to less friction during the life of the prosthetic valve because the leaflets are less likely to rub against the frame and/or skirt during opening and closing cycles of the prosthetic valve.

[0078] As described above, the frames 312, 312’, and 312” can be formed from a plastically- expandable material. When a prosthetic valve including a plastically-expandable frame 312, 312’, or 312” is radially crimped onto a delivery apparatus (such as the delivery apparatus 200), the frame 312, 312’, or 312” can be radially compressed to a smaller diameter while maintaining the position of the window frames 330 radially inward from the adjacent row of cells, due to the fact that a relatively small force is applied to the window frames 330 by the crimping apparatus compared to the adjacent stmts along the outflow end portion of the frame. Similarly, when the prosthetic valve is radially expanded at an implantation site (such as by inflation of the balloon 218), the frame 312, 312’, or 312” is expanded to a larger diameter such that window frames 330 are maintained at a radially inward position relative to the adjacent row of cells. In some examples, when the frame is in a radially compressed state and a radially expanded state (or any state in between), the window frames 330 are always positioned radially inward from the rest of the frame 312, 312’, or 312”.

[0079] As described above, the frames 312, 312’, and 312” can be formed from a selfexpandable material, such as Nitinol. In some examples, a self-expandable frame 312, 312’, or 312” can be shape set with the window frames 330 positioned radially inwardly relative to the adjacent row of cells. When a prosthetic valve including a self-expandable frame 312, 312’, or 312” is radially compressed and placed into a delivery sheath of a delivery apparatus, the window frames 330 can deform relative to the adjacent row of cells, and in some examples, each window frame 330 can reside within an opening 339. When the prosthetic valve is deployed from the delivery sheath, the prosthetic valve can self-expand from the radially compressed state to a radially expanded state while the window frames 330 revert to their shape set state by moving or “popping out” from their respective openings 339.

Delivery Techniques [0080] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (for example, by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-stemotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0081] 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.

[0082] 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 valvc/pulmonary artery.

[0083] 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 trans ventricular 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.

[0084] 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.

[0085] 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.

Additional Examples of the Disclosed Technology

[0086] 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.

[0087] Example 1. A frame for a prosthetic heart valve, comprising: a central longitudinal axis extending from an inflow end of the frame to an outflow end of the frame; a plurality of interconnected struts defining a plurality of rows of cells, the plurality of rows arranged between the outflow end and the inflow end of the frame and including a first row of cells, wherein the plurality of interconnected struts includes a first row of struts and a second row of struts, wherein the first row of cells is at least partially defined by the first and second rows of struts; a plurality of commissure window elements, each comprising: a commissure window frame; a first support post which couples the commissure window frame to the first row of struts; and a second support post which couples the commissure window frame to the second row of struts; wherein each commissure window element is disposed adjacent to a cell of the first row of cells and wherein the first and second support posts extend radially inward from the first and second rows of struts such that the commissure window frames are disposed radially inward relative to the first row of cells.

[0088] Example 2. The frame of any example herein, particularly example 1, wherein the frame defines a circumference and the commissure window elements of the plurality of commissure window elements are spaced equally around the circumference.

[0089] Example 3. The frame of any example herein, particularly any one of examples 1-2, wherein the plurality of commissure window elements comprises three commissure window elements.

[0090] Example 4. The frame of any example herein, particularly any one of examples 1-3, wherein each commissure window frame is positioned radially inward at least 1 mm relative to the first row of cells.

[0091] Example 5. The frame of any example herein, particularly any one of examples 1-3, wherein first support post is coupled to a peak formed by the first row of struts and the second support post is coupled to a peak formed by the second row of struts.

[0092] Example 6. The frame of any example herein, particularly example 5, wherein the first and second support posts extend radially inward at an angle of less than 45 degrees relative to a line which extends through the peak formed by the first row of struts and the peak formed by the second row of struts.

[0093] Example 7. The frame of any example herein, particularly any one of examples 1-6, wherein the commissure window frame is rectangular.

[0094] Example 8. A prosthetic heart valve, comprising: a frame comprising a plurality of interconnected struts arranged in a plurality of rows of struts defining a plurality of rows of cells; and a plurality of commissure supports coupled to respective first cells of one of the rows of cells, wherein the commissure supports are disposed radially inward relative to the first cells; a plurality of leaflets forming a plurality of commissures coupled to the commissure supports.

[0095] Example 9. The prosthetic heart valve of any example herein, particularly example 8, wherein each commissure support comprises a commissure support portion and at least one radially inwardly angled strut that connects the commissure support portion to a respective first cell.

[0096] Example 10. The prosthetic heart valve of any example herein, particularly example 9, wherein the at least one radially inward strut comprises first and second radially inward struts, wherein the first radially inwardly angled strut extends from a peak of a first row struts of the plurality of rows of struts and the second radially inwardly angled strut extends from a peak of a second row of stmts of the plurality of rows of stmts.

[0097] Example 11. The prosthetic heart valve of example 9, wherein the at least one radially inwardly angled stmt comprises exactly one radially inwardly angled strut.

[0098] Example 12. The prosthetic heart valve of any example herein, particularly any one of examples 9-11, wherein each commissure support is disposed radially inward relative to an entirety of a remaining portion of the frame.

[0099] Example 13. The prosthetic heart valve of example herein, particularly any one of examples 8-12, wherein each commissure comprises an adjacent pair of commissure tabs of adjacent leaflets of the plurality of leaflets, wherein the commissure tabs connected to the commissure support portion.

[0100] Example 14. A prosthetic heart valve, the prosthetic valve comprising: a frame comprising: a longitudinal axis extending from an inflow end of the frame to an outflow end of the frame; a plurality of interconnected struts defining a plurality of rows of cells, the plurality of rows arranged between the outflow end and the inflow end of the frame and including a first row of cells, wherein the plurality of interconnected struts comprises a first row of angled struts and a second row of angled struts, wherein the first row of cells is at least partially defined by the first and second rows of stmts; a plurality of commissure window elements, each comprising: a commissure window frame; at least one support post which couples the commissure window frame to the first row of stmts; and wherein the at least one support post extends inward towards the longitudinal axis such that each commissure window frame is disposed radially inward of the first row of cells; and a leaflet structure positioned within the frame and comprising a plurality of leaflets connected to each other at commissures, wherein each commissure is coupled to one of the plurality of commissure window frames.

[0101] Example 15. The prosthetic heart valve of any example herein, particularly example 14, wherein the prosthetic valve is radially compressible to a radially compressed state and radially expandable to an expanded state.

[0102] Example 16. The prosthetic heart valve of any example herein, particularly any one of examples 14-15, wherein the prosthetic valve is configured to be deployed to a plurality of working diameters.

[0103] Example 17. The prosthetic heart valve of any example herein, particularly any one of examples 14-16, wherein each commissure comprises an adjacent pair of commissure tabs of adjacent leaflets of the plurality of leaflets, wherein the commissure tabs extend through a window of a corresponding window frame.

[0104] Example 18. The prosthetic heart valve of any example herein, particularly any one of examples 14-17, wherein the at least one support post has a first end connected to the first row of struts and a second end connected to the window frame.

[0105] Example 19. The prosthetic heart valve of any example herein, particularly any one of examples 14-18, wherein the cells of the first row of cells are hexagonal.

[0106] Example 20. The prosthetic heart valve of any example herein, particularly any one of examples 14-19, wherein the plurality of rows of cells defines a cylindrical main body of the frame. [0107] Example 21 . The prosthetic heart valve of any example herein, particularly example 20, wherein the window frames arc disposed radially inward of an entirety of the main body of the frame.

[0108] Example 22. A prosthetic heart valve, comprising: a frame comprising: a longitudinal axis extending from an inflow end of the frame to an outflow end of the frame; a plurality of interconnected struts comprising a first row of angled struts and a second row of angled struts, wherein a first row of cells of the frame is at least partially defined by the first and second rows of struts; a plurality of commissure supports, each comprising: a commissure support portion; a first support post which couples the commissure support portion to the first row of struts; and wherein the first support post extends inward towards the longitudinal axis such that each commissure support portion is disposed radially inward of the first row of cells.

[0109] Example 23. The prosthetic heart valve of any example herein, particularly example 22, wherein each commissure support of the plurality of commissure supports further comprises one or more adjustable support posts.

[0110] Example 24. The prosthetic heart valve of any example herein, particularly example 23, wherein each of the adjustable support posts is coupled at a first end to the commissure support and coupled at a second end to the second row of angled struts.

[0111] Example 25. The prosthetic heart valve of any example herein, particularly any one of examples 23-24, wherein each adjustable support post comprises an expansion section that can expand lengthwise of the adjustable support post when the frame is radially compressed.

[0112] Example 26. The prosthetic heart valve of any example herein, particularly any one of examples 22-25, and further comprising a leaflet structure positioned within the frame and comprising a plurality of leaflets connected to each other at commissures, wherein each commissure is coupled to one of the plurality of commissure support portions.

[0113] Example 27. The prosthetic heart valve of any example herein, particularly example 26, wherein the commissure support portions comprise commissure window frames.

[0114] Example 28. The prosthetic heart valve of any example herein, particularly example 13, wherein each commissure support portion comprises a commissure window frame, and wherein the commissures tabs of each commissure extend through one of the commissure window frames.

[0115] The features described herein with regal'd 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 commissure window element can be combined with any one or more features of another commissure window element.

[0116] 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 frame comprising a plurality of interconnected struts arranged in a plurality of rows of struts defining a plurality of rows of cells; and a plurality of commissure supports coupled to respective first cells of one of the rows of cells, wherein the commissure supports are disposed radially inward relative to the first cells; a plurality of leaflets forming a plurality of commissures coupled to the commissure supports.

2. The prosthetic heart valve of claim 1, wherein each commissure support comprises a commissure support portion and at least one radially inwardly angled stmt that connects the commissure support portion to a respective first cell.

3. The prosthetic heart valve of claim 2, wherein the at least one radially inwardly angled stmt comprises first and second radially inwardly angled struts, wherein the first radially inwardly angled strut extends from a peak of a first row struts of the plurality of rows of struts and the second radially inwardly angled stmt extends from a peak of a second row of stmts of the plurality of rows of stmts.

4. The prosthetic heart valve of claim 2, wherein the at least one radially inwardly angled stmt comprises exactly one radially inwardly angled strut.

5. The prosthetic heart valve of any one of claims 1-4, wherein each commissure support is disposed radially inward relative to an entirety of a remaining portion of the frame.

6. The prosthetic heart valve of any one of claims 2-4, wherein each commissure comprises an adjacent pair of commissure tabs of adjacent leaflets of the plurality of leaflets, wherein the commissure tabs connected to the commissure support portion.

7. The prosthetic heart valve of claim 6, wherein each commissure support portion comprises a commissure window frame, and wherein the commissures tabs of each commissure extend through one of the commissure window frames.

8. A prosthetic heart valve, comprising: a frame comprising: a longitudinal axis extending from an inflow end of the frame to an outflow end of the frame; a plurality of interconnected stmts comprising a first row of angled struts and a second row of angled struts, wherein a first row of cells of the frame is at least partially defined by the first and second rows of struts; a plurality of commissure supports, each comprising: a commissure support portion; a first support post which couples the commissure support portion to the first row of struts; and wherein the first support post extends inward towards the longitudinal axis such that each commissure support portion is disposed radially inward of the first row of cells.

9. The prosthetic heart valve of claims 8, wherein the first support post has a first end connected to the first row of struts and a second end connected to the commissure support portion.

10. The prosthetic heart valve of any one of claims 8-9, wherein each commissure support of the plurality of commissure supports further comprises one or more adjustable support posts.

11. The prosthetic heart valve of claim 10, wherein each of the adjustable support posts is coupled at a first end to the commissure support and coupled at a second end to the second row of angled struts.

12. The prosthetic heart valve of any of claims 10-11 , wherein each adjustable support post comprises an expansion section that can expand lengthwise of the adjustable support post when the frame is radially compressed.

13. The prosthetic heart valve of any one of claims 8-12, and further comprising a leaflet structure positioned within the frame and comprising a plurality of leaflets connected to each other at commissures, wherein each commissure is coupled to one of the plurality of commissure support portions.

14. The prosthetic heart valve of claim 13, wherein the commissure support portions comprise commissure window frames.

15. A frame for a prosthetic heart valve, comprising: a central longitudinal axis extending from an inflow end of the frame to an outflow end of the frame; a plurality of interconnected stmts defining a plurality of rows of cells, the plurality of rows arranged between the outflow end and the inflow end of the frame and including a first row of cells, wherein the plurality of interconnected struts includes a first row of stmts and a second row of struts, wherein the first row of cells is at least partially defined by the first and second rows of stmts; a plurality of commissure window elements, each comprising: a commissure window frame; a first support post which couples the commissure window frame to the first row of stmts; and a second support post which couples the commissure window frame to the second row of stmts; wherein each commissure window element is disposed adjacent to a cell of the first row of cells and wherein the first and second support posts extend radially inward from the first and second rows of stmts such that the commissure window frames are disposed radially inward relative to the first row of cells.

16. The frame of claim 15, wherein the frame defines a circumference and the commissure window elements of the plurality of commissure window elements arc spaced equally around the circumference.

17. The frame of any one of claims 15-16, wherein each commissure window frame is positioned radially inward at least 1 mm relative to the first row of cells.

18. The frame of any one of claims 15-17, wherein the first support post is coupled to a peak formed by the first row of struts and the second support post is coupled to a peak formed by the second row of stmts.

19. The frame of claim 18, wherein the first and second support posts extend radially inward at an angle of less than 45 degrees relative to a line which extends through the peak formed by the first row of stmts and the peak formed by the second row of stmts.

20. The frame of any one of claims 14-19, wherein the commissure window frame is rectangular.