Connecting skirt for attaching leaflets to a frame of a prosthetic heart valve

Abstract

Methods and assemblies for attaching valve leaflets and a connecting skirt to a frame of a prosthetic heart valve are disclosed. A prosthetic heart valve comprises a frame having an inflow end and an outflow end, the frame comprising a plurality of struts. The prosthetic heart valve further comprises a valvular structure comprising a plurality of leaflets, each leaflet comprising a coaptation edge portion and a cusp edge portion. A connecting skirt is disposed between the cusp edge portions of the leaflets and the frame, wherein the connecting skirt is secured to the frame with first stitches to adjacent struts to form a first stitch line, and wherein the cusp edge portions of the leaflets are stitched to the connecting skirt with second stitches along a second stitch line that is parallel to and axially offset from the first stitch line toward the inflow end of the frame.

Description

Attorney Docket No: THVVA-13343WO01 CONNECTING SKIRT FOR ATTACHING LEAFLETS TO A FRAME OF A PROSTHETIC HEART VALVE CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 613,199, filed on December 21, 2023, which is incorporated by reference herein in its entirety. FIELD

[0002] The present disclosure relates to prosthetic heart valves and to methods and assemblies for attaching leaflets to a frame of the prosthetic heart valve with one or more connecting skirts. 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 (e.g., 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 device and advanced through the patient’s vasculature (e.g., through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic 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 valve, or by deploying the prosthetic valve from a sheath of the delivery device so that the prosthetic valve can self-expand to its functional size.

[0004] Most expandable prosthetic heart valves comprise a radially expandable and compressible cylindrical metal frame or stent and prosthetic leaflets mounted inside the frame.Attorney Docket No: THVVA-13343WO01 Each leaflet can comprise a main body with a cusp edge portion. The cusp edge portion of each leaflet can be coupled to struts of the frame (either directly or through an inner skirt disposed around an inner surface of the frame). The leaflets of the prosthetic heart valve are configured to open and close to regulate a flow of blood through the prosthetic heart valve, from an inflow end to an outflow end of the prosthetic heart valve.

[0005] Following implantation of a prosthetic heart valve in the native aortic valve, some patients may require further intervention that requires access to a coronary artery. Typically, a coronary artery is accessed with a catheter or other medical instrument that is inserted through the frame of the prosthetic heart valve in a direction toward the coronary artery. Thus, a need exists for prosthetic heart valves that maximize access to the coronary arteries in a subsequent, post-implantation procedure. SUMMARY

[0006] Described herein are prosthetic heart valves, delivery apparatus, and methods for implanting prosthetic heart valves. Also disclosed herein are prosthetic heart valves comprising components such as a frame with openings and a valvular assembly arranged within and mounted to the frame, sometimes with a connecting skirt positioned between the frame and the valvular assembly.

[0007] After a prosthetic heart valve is implanted within the native aortic valve, access to a coronary artery or coronary ostium can be achieved through the openings in the frame. To maximize blood flow to the coronary arteries after prosthetic valve placement or provide re- access to the ostium with a catheter or other instrument, a relative position of the components of the prosthetic valve can be optimized. According to one aspect, the leaflets of the valvular assembly and the connecting skirt can be positioned relative to struts of the frame to maximize exposure of the frame openings downstream of the leaflets, thereby increasing blood flow and / or instrument access through the frame.

[0008] A prosthetic heart valve can comprise a frame and a valvular structure coupled to the frame. In addition to these components, a prosthetic heart valve can further comprise one or more of the components disclosed herein.Attorney Docket No: THVVA-13343WO01

[0009] In some examples, the frame is radially expandable and compressible and has an inflow end and an outflow end, wherein the frame can further comprise a plurality of struts defining openings or cells between them.

[0010] In some examples, a valvular structure can comprise a plurality of leaflets, each leaflet comprising a coaptation edge and a cusp edge.

[0011] In some examples, the prosthetic heart valve can comprise a reinforcing member or chord secured to the leaflets.

[0012] In some examples, the prosthetic heart valve can comprise a connecting skirt positioned between the frame and the cusp edge of each leaflet.

[0013] In some examples, the connecting skirt is secured to the frame with first stitches to adjacent struts to form a first stitch line.

[0014] In some examples, the cusp edge portions of each leaflet are stitched to the connecting skirt with second stitches along a second stitch line.

[0015] In some examples, the second stitch line is parallel to and axially offset from the first stitch line toward the inflow end of the frame.

[0016] In some examples, the second stitch line is offset from the first stitch line by a distance that is constant around a circumference of the frame.

[0017] In some examples, the reinforcing member is axially offset from the first stitch line toward the inflow end of the frame.

[0018] In some examples, the reinforcing member extends along an inflow surface of the cusp edge portion of each leaflet and is axially offset from the first stitch line toward the inflow end of the frame.

[0019] In some examples, the reinforcing member extends along an outflow surface of the cusp edge portion of each leaflet and is axially offset from the first stitch line toward the inflow end of the frame.Attorney Docket No: THVVA-13343WO01

[0020] In some examples, the reinforcing member is secured to the leaflets and the connecting skirt with the second stitches along the second stitch line.

[0021] In some examples, the axially offset distance between the first stitch line and the reinforcing member is between 0.5-0.8 mm.

[0022] In some examples, the cusp edge of each leaflet is folded toward the outflow end of the frame along a bending axis.

[0023] In some examples, the reinforcing member extends along an outflow surface of the cusp edge portion of each leaflet along the bending axis.

[0024] In some examples, the cusp edge of each leaflet is not folded and extends towards the inflow end of the frame.

[0025] In some examples, the connecting skirt is folded to form an inner layer, an outer layer, and a fold, wherein the fold is oriented toward the outflow end of the frame such that both inner and outer layers extend from the fold toward the inflow end of the frame.

[0026] In some examples, each of the first and second stitches extend through the inner and outer layers of the connecting skirt.

[0027] In some examples, a prosthetic heart valve comprises one or more of the components recited in Examples 1-16 and 25 below.

[0028] In some examples, a prosthetic heart valve comprises a radially expandable and compressible frame having an inflow end and an outflow end, the frame comprising a plurality of struts defining openings between them. The prosthetic heart valve further comprises a valvular structure comprising a plurality of leaflets, each leaflet comprising a coaptation edge portion and a cusp edge portion, and a connecting skirt disposed between the cusp edge portions of the leaflets and the frame. The connecting skirt is secured to the frame with first stitches to adjacent struts to form a first stitch line, wherein the cusp edge portions of the leaflets are stitched to the connecting skirt with second stitches along a second stitch line that is parallel to and axially offset from the first stitch line toward the inflow end of the frame.Attorney Docket No: THVVA-13343WO01

[0029] In some examples, a prosthetic heart valve comprises a radially expandable and compressible frame having an inflow end and an outflow end, the frame comprising a plurality of struts defining openings between them, a valvular structure comprising a plurality of leaflets, each leaflet comprising a coaptation edge portion and a cusp edge portion, wherein the cusp edge portion of each leaflet is folded toward the outflow end of the frame along a bending axis, and a reinforcing member extends along an outflow surface of the cusp edge portion of each leaflet along the bending axis. The prosthetic heart valve further comprises a connecting skirt disposed between the cusp edge portions of the leaflets and the frame, wherein the connecting skirt is connected to the frame with first stitches to adjacent struts to form a first stitch line, and wherein the cusp edge portions of the leaflets are stitched to the connecting skirt with second stitches along a second stitch line that is axially offset from the first stitch line toward the inflow end of the frame.

[0030] A method of assembling a prosthetic heart valve comprising a frame with struts and a plurality of leaflets with cusp edge portions is provided. In some examples, the method can comprise stitching a connecting skirt to the frame and stitching the connecting skirt to the leaflets. In addition to these steps, the method of assembling a prosthetic heart valve can further comprise one or more of the steps disclosed herein.

[0031] In some examples, the method can comprise stitching a connecting skirt to adjacent struts of the frame with a plurality of first stitches to form a first stitch line.

[0032] In some examples, the method can comprise stitching the connecting skirt to cusp edge portions of the leaflets with a plurality of second stitches to form a second stitch line.

[0033] In some examples, the second stitch line is parallel to and axially offset from the first stitch line toward the inflow end of the frame.

[0034] In some examples, the second stitch line is offset from the first stitch line by a distance that is constant around a circumference of the frame.Attorney Docket No: THVVA-13343WO01

[0035] In some examples, the method can comprise folding a cusp edge portion of each leaflet toward the outflow end of the frame along a bending axis and securing a reinforcing member along an outflow surface of the cusp edge portion of each leaflet along the bending axis.

[0036] In some examples, the reinforcing member is axially offset from the first stitch line by 0.5-0.8 mm.

[0037] In some examples, the method can comprise securing the reinforcing member to the cusp edge portion of each leaflet and stitching the reinforcing member to the cusp edge portion of each leaflet and the connecting skirt with the second stitches along the second stitch line.

[0038] In some examples, the method can comprise securing a reinforcing member along an inflow surface of the cusp edge portion of each leaflet in a position axially offset from the first stitch line toward the inflow end of the frame.

[0039] In some examples, the method can comprise securing a reinforcing member along an outflow surface of the cusp edge portion of each leaflet in a position axially offset from the first stitch line toward the inflow end of the frame.

[0040] In some examples, a method of assembling a prosthetic heart valve comprising a frame and a plurality of leaflets comprises stitching a connecting skirt to adjacent struts of the frame with a plurality of first stitches to form a first stitch line and stitching the connecting skirt to cusp edge portions of the leaflets with a plurality of second stitches to form a second stitch line, which is parallel to and axially offset from the first stitch line toward the inflow end of the frame.

[0041] In some examples, a method of assembling a prosthetic heart valve comprising one or more of the steps recited in Examples 17-24 and 26 below.

[0042] 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,Attorney Docket No: THVVA-13343WO01 and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] FIG. 1A is a perspective view of a prosthetic heart valve, according to one example.

[0044] FIG. 1B is a perspective view of the prosthetic valve of FIG. 1A with the components on the outside of the frame shown in transparent lines for purpose of illustration.

[0045] FIG. 2 is a side view of a prosthetic heart valve with components on an outside of a frame of the prosthetic heart valve removed, according to another example, which includes a connecting skirt coupling a cusp edge portion of a leaflet to the frame of the prosthetic heart valve.

[0046] FIG. 3 is a partial, detail view of an interior surface of the prosthetic heart valve of FIG. 2.

[0047] FIG. 4 is a side view of an example of a delivery apparatus configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site.

[0048] FIG. 5 is a side view of the distal end portion of the delivery apparatus of FIG. 4 with a prosthetic heart valve mounted on a valve mounting portion of the delivery apparatus.

[0049] FIG. 6 is a cross-sectional view of the prosthetic heart valve of FIG. 2, radially compressed onto and mounted around an inflatable balloon of a delivery apparatus.

[0050] FIG. 7 is a side view of a prosthetic heart valve with components on an outside of a frame of the prosthetic heart valve removed, according to another example, which includes a connecting skirt coupling a cusp edge portion of a leaflet to the frame of the prosthetic heart valve, the connecting skirt including side extension portions that cover apices at an inflow end of the frame.

[0051] FIG. 8 is a side view of the frame of the prosthetic heart valve of FIG. 7.Attorney Docket No: THVVA-13343WO01

[0052] FIG. 9 is a plan view of an example of a connecting skirt for connecting a cusp edge portion of a leaflet to the frame of the prosthetic heart valve of FIG. 7.

[0053] FIG. 10 is a plan view of an example of a leaflet of the prosthetic heart valve of FIG. 7.

[0054] FIG. 11 is a perspective view of the leaflet of FIG. 10 in a folded configuration.

[0055] FIG. 12 is a cross-sectional view of the prosthetic valve of FIG. 7 showing an exemplary attachment of the cusp edge portion of a leaflet to the frame via the connecting skirt of FIG. 9.

[0056] FIG. 13 is a plan view of the connecting skirt of FIG. 9 illustrating a folding method for securing the connecting skirt to a leaflet.

[0057] FIG. 14 is a plan view of an inner surface of the leaflet of FIG. 10 illustrating the connecting skirt of FIG. 9 placed along and attached to the inner surface of the cusp edge portion of the leaflet.

[0058] FIG. 15 is a plan view of an outer surface of the leaflet of FIG. 10 illustrating the connecting skirt of FIG. 9 attached to the cusp edge portion of the leaflet.

[0059] FIG. 16 is a plan view of the leaflet of FIG. 10 including the connecting skirt of FIG. 9 and a reinforcing member positioned along the cusp edge portion of the leaflet.

[0060] FIG. 17 is a plan view of a plurality of leaflets and connecting skirts secured together to form a valvular structure for the prosthetic heart valve of FIG. 7.

[0061] FIG. 18 is an exploded, perspective view of the leaflet of FIG. 10 and the connecting skirt of FIG. 9 in a configuration for attachment to the frame of FIG. 8.

[0062] FIG. 19 is a detail view of the connecting skirt of FIG. 9 secured to struts of the frame of FIG. 8 from the perspective of an interior of the frame.

[0063] FIG. 20 is a detail view of the connecting skirt of FIG. 9 secured to struts of the frame of FIG. 8 from the perspective of an exterior of the frame.

[0064] FIG. 21 is a perspective, detail view from an inside of the prosthetic heart valve of FIG. 7 illustrating inner surfaces of two extension portions of two adjacent connecting skirts and a connection between the two extension portions.Attorney Docket No: THVVA-13343WO01

[0065] FIG. 22 is a perspective view of the prosthetic heart valve of FIG. 7 illustrating a method for securing an outer sealing member to an outer surface of the struts of the frame of the prosthetic heart valve.

[0066] FIG. 23 is a plan view of an example of a commissure attachment member, shown in a flattened configuration.

[0067] FIG. 24 is a perspective view of one of the commissures of the prosthetic heart valve of FIG. 7, the commissure including the commissure attachment member of FIG. 23.

[0068] FIG. 25 is a cross-sectional view of one of the commissures of the prosthetic heart valve of FIG. 7, the commissure including the commissure attachment member of FIG. 23.

[0069] FIG. 26 is a cross-sectional view of the prosthetic heart valve of FIG. 7 radially compressed onto and around an inflatable balloon of a delivery apparatus.

[0070] FIG. 27 is a cross-sectional view of a portion of a prosthetic heart valve showing a connection of the cusp edge portion of a leaflet to the frame of the prosthetic heart valve, according to another example.

[0071] FIG. 28 is a cross-sectional view of a portion of a prosthetic heart valve showing the connection of the cusp edge portion of a leaflet to the frame of the prosthetic heart valve, according to another example.

[0072] FIG. 29 is a cross-sectional view of a portion of a prosthetic heart valve showing the connection of the cusp edge portion of a leaflet to the frame of the prosthetic heart valve, according to another example. DETAILED DESCRIPTION General Considerations

[0073] 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, aloneAttorney Docket No: THVVA-13343WO01 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.

[0074] 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.

[0075] 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.

[0076] 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 (e.g., out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward theAttorney Docket No: THVVA-13343WO01 implantation site (e.g., 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. Examples of the Disclosed Technology

[0077] Described herein are examples of prosthetic heart valves, leaflet assemblies for prosthetic heart valves, connecting skirts, and methods for assembling leaflets assemblies and valvular structures to a frame of the prosthetic heart valve using one or more connecting skirts. The prosthetic heart valves can comprise a frame and a valvular structure attached to the frame, the valvular structure comprising a plurality of leaflets. In some examples, a connecting skirt can be secured to a cusp edge portion of a leaflet of the valvular structure. The portion of the connecting skirt secured to the cusp edge portion of the leaflet can then be secured to struts of the frame of the prosthetic heart valve, thereby securing the cusp edge portion of the leaflet to the frame, proximate to an inflow end of the frame. The connecting skirt can include side extension portions that extend outward from the cusp edge portion of the leaflet and across struts of the frame that are arranged between cusp edge portions of adjacent leaflets, when the connecting skirt is attached to struts of the frame. In this way, the side extension portions can cover inner surfaces of struts of the frame and / or apices of the frame at the inflow end of the frame.

[0078] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed configuration during delivery, and then expanded to the radially expanded configuration 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. In some examples, the prosthetic valve can be deployed from the delivery apparatus at the implantation site (e.g., a native valve of a heart) via inflating an inflatable balloon of the delivery apparatus. When radially compressed onto the inflatable balloon of the delivery apparatus, inner surfaces of the frame of the prosthetic valve can face the balloon.Attorney Docket No: THVVA-13343WO01

[0079] FIG. 1A shows an exemplary prosthetic valve 150, 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.

[0080] 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. WO2020 / 247907, which is incorporated by reference herein. 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 by reference herein.

[0081] FIG. 1A is a perspective view of a prosthetic heart valve (e.g., prosthetic valve) 150, according to one example. The illustrated prosthetic valve is adapted to be implanted in the native aortic annulus, although in other examples it can be adapted to be implanted in the other native annuluses of the heart (e.g., the pulmonary, mitral, and tricuspid valves). The prosthetic valve can also be adapted to be implanted in other tubular organs or passageways in the body.

[0082] The prosthetic valve 150 can have three main components: a stent or frame, 152, a valvular structure 154, and a sealing member 156. FIG. 1B is a perspective view of theAttorney Docket No: THVVA-13343WO01 prosthetic valve 150 with the components on the outside of the frame 152 (including the sealing member 156) shown in transparent lines for purposes of illustration. The prosthetic valve 150 can have an inflow end 166 and an outflow end 168.

[0083] The valvular structure 154 can comprise three leaflets 160, collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, although in other examples there can be greater or fewer number of leaflets (e.g., one or more leaflets 160). In some examples, the leaflets 160 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated by reference herein.

[0084] Each leaflet 160 can be coupled to the frame 152 along its inflow edge 162 (the lower edge in the figures; also referred to as “cusp edges”) and at commissures 164 of the valvular structure 154 where adjacent portions (e.g., commissure tabs) of two leaflets are connected to each other. In some examples, the commissures 164 can comprise an attachment member (e.g., comprising fabric, flexible polymer, or the like) arranged across a cell (e.g., commissure cell) of the frame 152, the cell formed by struts of the frame. The attachment member can be secured to the struts of the frame forming the cell and the adjacent portions of the two leaflets can be connected to the attachment member to form the commissure 164 (e.g., as shown in FIGS. 2, and 23-25, as described further below).

[0085] In some examples, a reinforcing element or connecting skirt, such as a fabric strip, can be connected directly to the cusp edges of the leaflets and to the struts of the frame to couple the cusp edges of the leaflets to the frame (e.g., as shown in FIGS. 2 and 3, as described further below).

[0086] The frame 152 can be made of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel titanium alloy (NiTi), such as nitinol), as known in the art. When constructed of a plastically-expandable material, the frame 152 (and thus the prosthetic valve 150) can be crimped to a radially collapsed configuration on a delivery apparatus (e.g., catheter) and then expanded inside a patient by an inflatable balloon orAttorney Docket No: THVVA-13343WO01 equivalent expansion mechanism. When constructed of a self-expandable material, the frame 152 (and thus the prosthetic valve 150) can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of a delivery apparatus. Once inside the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.

[0087] Suitable plastically-expandable materials that can be used to form the frame 152 include, without limitation, stainless steel, a biocompatible, high-strength alloys (e.g., a cobalt-chromium or a nickel-cobalt-chromium alloys), polymers, or combinations thereof. In particular examples, frame 152 is made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N® alloy (SPS Technologies, Jenkintown, Pennsylvania), which is equivalent to UNS R30035 alloy (covered by ASTM F562-02). MP35N® alloy / UNS R30035 alloy comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0088] The frame 152 in the illustrated example comprises a plurality of circumferentially extending rows of angled struts 172 defining rows of open cells, or openings, 174 of the frame. The frame 152 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 166 to the outflow end 168 of the frame 152 as shown, or the frame 152 can vary in diameter along the height of the frame, as disclosed in U.S. Patent Publication No. 2012 / 0239142, which is incorporated by reference herein.

[0089] The frame 152, at each of the inflow end 166 and the outflow end 168, may comprise a plurality of apices 180 spaced apart from one another around a circumference of the frame 152.

[0090] The sealing member 156 in the illustrated example is mounted on the outside of the frame 152 and functions to create a seal against the surrounding tissue (e.g., the native leaflets and / or native annulus) to prevent or at least minimize paravalvular leakage. The sealing member 156 can comprise an inner layer 176 (which can be in contact with the outer surface of the frame 152) and an outer layer 178. The sealing member 156 can be connected to the frame 152 using suitable techniques or mechanisms. For example, the sealing member 156 can be sutured to the frame 152 via sutures that can extend around the struts 172 and through the inner layer 176. InAttorney Docket No: THVVA-13343WO01 alternative examples, the inner layer 176 can be mounted on the inner surface of the frame 152, while the outer layer 178 is on the outside of the frame 152.

[0091] The outer layer 178 can be configured or shaped to extend radially outward from the inner layer 176 and the frame 152 when the prosthetic valve 150 is deployed. When the prosthetic valve is fully expanded outside of a patient’s body, the outer layer 178 can expand away from the inner layer 176 to create a space between the two layers. Thus, when implanted inside the body, this allows the outer layer 178 to expand into contact with the surrounding tissue.

[0092] Additional details regarding the prosthetic valve 150 and its various components are described in U.S. Patent Publication No. 2018 / 0028310, which is incorporated by reference herein.

[0093] FIG. 2 is a side view of a prosthetic heart valve 200, according to another example. The prosthetic heart valve 200 can be similar to the prosthetic valve 150 of FIGS. 1A and 1B. For example, the prosthetic heart valve 200 can comprise a frame 202 and a valvular structure 204 which can be the same or similar to the frame 152 and valvular structure 154 of the prosthetic valve 150. For example, the frame 202 and the valvular structure 204 can comprise similar materials and / or have a similar geometry to the frame 152 and valvular structure 154, respectively, of the prosthetic valve 150, as described above with reference to FIGS. 1A and 1B.

[0094] In FIG. 2, the exterior of the frame 202 is shown with no sealing member arranged around the frame, thereby providing a view of the components coupling the valvular structure 204 to the frame 202. However, in some examples, the prosthetic heart valve 200 can include an outer sealing member (e.g., outer skirt) arranged around and coupled to an outer surface of the frame 202, such as the sealing member 156 shown in FIG. 1A.

[0095] For example, FIG. 3 is a partial, detail view of an interior surface of the prosthetic heart valve 200, showing an outer sealing member 206 arranged around an outer surface of the frame 202. Thus, FIG. 2 is an exterior view and FIG. 3 is an interior view of the prosthetic heart valve 200.Attorney Docket No: THVVA-13343WO01

[0096] Similar to the frame 152 of the prosthetic valve 150, the frame 202 of the prosthetic heart valve 200 comprises a plurality of angled and interconnected struts 208. As shown in FIG. 2, the struts 208 can be arranged into a plurality of circumferentially extending rows of angled struts 208 that are disposed between an inflow end 210 and an outflow end 212 of the frame 202. The rows of struts 208 define rows of cells or openings (e.g., open cells) 214 of the frame 202. The frame 202, at each of the inflow end 210 and the outflow end 212, can comprise a plurality of apices 254 spaced apart from one another around a circumference of the frame 202. The apices 254 can be formed by the intersection of struts 208 at the inflow end 210 and the outflow end 212. Further, the frame 202 can include a plurality of strut junctions 256 formed by the intersection of struts 208 at location on the frame 202 between the inflow end 210 and the outflow end 212.

[0097] As shown in FIG. 2, each leaflet 216 of the valvular structure 204 can be coupled to the frame 202 along its inflow edge (also referred to as “cusp edges”) and at commissures 238 of the valvular structure 204 where adjacent portions (e.g., commissure tabs) of two leaflets are connected to each other. In some examples, as shown in FIG. 2 and described further below, the commissures 238 can comprise an attachment member 220 (e.g., comprising fabric, flexible polymer, or the like) arranged across a cell 214 (e.g., commissure cell) of the frame 202. The attachment member 220 can be secured to the struts 208 of the frame 202 forming the cell 214 via stitching or sutures 248. Further, the adjacent portions of the two leaflets 216 can be connected to the attachment member 220 to form the commissure 238 (e.g., as shown in FIG. 2 and as described further below with reference to FIGS. 7 and 23-25).

[0098] In some examples, as shown in FIGS. 2 and 3, cusp edges 218 of the leaflets 216 can be coupled (e.g., secured) to the frame 202 with a connecting skirt (or member) 260. For example, in some examples, the cusp edge 218 of each leaflet 216 can be connected directly to a corresponding (e.g., individual) connecting skirt 260. Each connecting skirt 260 (e.g., one for each leaflet 216) can then be connected directly to the struts 208 of the frame 202, thereby coupling the cusp edges 218 of the leaflets 216 to the frame. In other examples, the connecting skirt 260 can be a single piece of material that is connected to all of the leaflets 216.Attorney Docket No: THVVA-13343WO01

[0099] For example, as shown in FIG. 2, the connecting skirts 260 can be secured to strut junctions 256 by first sutures 272 and can be further connected, along their length, to struts 208 by second sutures (such as in the form of whip stitches) 274.

[0100] As shown in FIG. 3, a portion of the struts 208 of the frame 202 and a portion of the apices 254 at the inflow end 210 are exposed on an inside of the frame 202, at locations between adjacent leaflets 216 and connecting skirts 260.

[0101] FIGS. 4 and 5 show a delivery apparatus 300, according to an example, that can be used to implant an expandable prosthetic heart valve (e.g., prosthetic valve 150 of FIGS. 1A and 1B and / or prosthetic heart valve 200 of FIGS. 2 and 3), or another type of expandable prosthetic medical device (such as a stent). In some examples, the delivery apparatus 300 is specifically adapted for use in introducing a prosthetic valve into a heart.

[0102] The delivery apparatus 300 in the illustrated example of FIGS. 4 and 5 is a balloon catheter comprising a handle 302 and a steerable, outer shaft 304 extending distally from the handle 302 (FIG. 4). The delivery apparatus 300 can further comprise an intermediate shaft 306 (which can also be referred to as a balloon shaft) that extends proximally from the handle 302 (FIG. 4) 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 (FIG. 4) and proximally from the handle 302 coaxially through the intermediate shaft 306.

[0103] 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 patient’s body.

[0104] 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 (FIG. 4). In some examples, a rotatable knob 314 can be mounted on the proximal end portion 310 (FIG. 4) andAttorney Docket No: THVVA-13343WO01 can be configured to rotate the intermediate shaft 306 around the central longitudinal axis 320 of the delivery apparatus 300 and relative to the outer shaft 304.

[0105] 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.

[0106] The intermediate shaft 306 can further include a distal end portion 316 that extends distally beyond a distal end of the outer shaft 304 (FIG. 4) when a distal end of the outer shaft 304 is positioned away from an inflatable balloon 318 of the delivery apparatus. A distal end portion of the inner shaft 308 can extend distally beyond the distal end portion 316 of the intermediate shaft 306 (FIG. 4).

[0107] The balloon 318 can be coupled to the distal end portion 316 of the intermediate shaft 306. For example, in some examples, a proximal end portion of the balloon 318 can be coupled to and / or around a distal end of the intermediate shaft 306 (FIG. 4).

[0108] The balloon 318 can comprise a distal end portion (or section) 332, a proximal end portion (or section) 333, and an intermediate portion (or section) 335, the intermediate portion 335 disposed between the distal end portion 332 and the proximal end portion 333 (FIG. 4).

[0109] In some examples, a distal end of the distal end portion 332 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 FIGS. 4 and 5), or to an alternate component at the distal end of the delivery apparatus 300 (e.g., a distal shoulder). In some examples, the intermediate portion 335 of the balloon 318 can overlay a valve mounting portion 324 of a distal end portion 309 of the delivery apparatus 300, the distal end portion 332 can overly a distal shoulder 326 of the delivery apparatus 300, and the proximal end portion 333 can surround a portion of the inner shaft 308. The valve mounting portion 324 and the intermediate portion 335 of the balloon 318 can be configured to receive a prosthetic heart valve 370 in a radially compressed state, as shown in FIG. 5. In some examples, the prosthetic heart valve 370 shown in FIG. 5 can be one of valve 150 of FIGS. 1A and 1B or valve 200 of FIGS. 2 and 3.Attorney Docket No: THVVA-13343WO01

[0110] In some examples, rotation of the intermediate shaft 306 can result in rotation of the balloon 318 and the prosthetic valve mounted thereon for rotational positioning of the prosthetic valve relative to the native anatomy at the target implantation site.

[0111] The balloon shoulder assembly is configured to maintain the prosthetic heart valve or other medical device at a fixed position on the balloon 318 during delivery through the patient’s vasculature. The balloon shoulder assembly can include a distal shoulder 326 (FIGS. 4 and 5) arranged within the distal end portion 332 of the balloon 318 and coupled to the distal end portion of the inner shaft 308. The distal shoulder 326 can be configured to resist movement of the prosthetic valve or other medical device mounted on the valve mounting portion 324 distally, in an axial direction (e.g., along central longitudinal axis 320), relative to the balloon 318.

[0112] The outer shaft 304 can include a distal tip portion 328 mounted on its distal end (FIGS. 4 and 5). 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 a prosthetic valve is mounted in the radially compressed state on the valve mounting portion 324 and during delivery of the prosthetic valve to the target implantation site (as shown in FIG. 5). As such, the distal tip portion 328 can be configured to resist movement of the prosthetic valve 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 (FIG. 5).

[0113] In some examples, the nose cone 322 can be disposed distal to and be coupled to the distal shoulder 326. In some examples, the nose cone 322 can be coupled to the distal end portion of the inner shaft 308.

[0114] In some examples, an annular space can be defined between an outer surface of the inner shaft 308 and an inner surface of the intermediate shaft 306. In some examples, the annular space can be referred to as an inner lumen of the intermediate shaft 306. In some examples, the annular space can be configured to receive fluid from a fluid source via the second port 340 of the adaptor 312 (e.g., the annular space is in fluid communication with the second port 340 of the adaptor 312). The annular space can be fluidly coupled to a fluid passageway formed betweenAttorney Docket No: THVVA-13343WO01 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 balloon 318 to inflate the balloon 318 and radially expand and deploy the prosthetic valve (e.g., prosthetic valve 370 shown in FIG. 5).

[0115] An inner lumen of the inner shaft 308 can be configured to receive a guidewire therethrough, for navigating the distal end portion 309 of the delivery apparatus 300 to the target implantation site. As introduced above, the first port 338 of the adaptor 312 can be coupled to the inner lumen and configured to receive the guidewire. For example, the distal end portion 309 of the delivery apparatus 300 can be advanced over the guidewire, to the target implantation site.

[0116] As shown in FIG. 4, the handle 302 can include a steering mechanism configured to adjust the curvature of the distal end portion 309 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 309 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.

[0117] The handle 302 can include one or more additional adjustment mechanisms. For example, in some examples, the handle 302 can include an adjustment mechanism 361 including an adjustment member, such as the illustrated rotatable knob 362. The adjustment mechanism 361 can be configured to adjust the axial position of the intermediate shaft 306 relative to the outer shaft 304. In some examples, the handle 302 can further include a locking mechanism, which can include a rotatable knob 378, the locking mechanism configured to retain (e.g., lock) the position of the intermediate shaft 306 relative to the handle 302 and allow for fine positioning of the prosthetic valve 370 at the implantation site.Attorney Docket No: THVVA-13343WO01

[0118] FIG. 6 is a cross-sectional view of the prosthetic heart valve 200 (FIGS. 2 and 3) radially compressed onto and mounted around the balloon 318, on the distal end portion 309 of the delivery apparatus 300. Specifically, the cross-sectional view of FIG. 6 is taken at the inflow end 210 of the frame 202. Thus, the apices 254 of the frame 202, at the inflow end 210, are seen in FIG. 6.

[0119] As shown in FIG. 6, the balloon 318 is wrapped and folded around the inner shaft 308, at the valve mounting portion 324 of the delivery apparatus 300. In some examples, as shown in FIG. 6, the balloon 318 includes a plurality of overlapping pleats or folds 390 when in its deflated configuration and when the prosthetic heart valve 200 is mounted on and radially compressed around the balloon 318. The balloon 318 can be folded in such a way that the pleats 390 result in a minimized folded balloon diameter (e.g., in its deflated configuration) which can reduce a diameter of the radially compressed prosthetic valve 200 when crimped thereon.

[0120] As shown in in FIGS. 2 and 3 and described above, an inner surface 224 (e.g., the surface facing an interior of the valve 200 and a central longitudinal axis of the valve 200) of the apices 254 and a portion of the struts 208 disposed between where adjacent connecting skirts 260 are connected to the frame 202 are exposed (e.g., not covered by skirt or leaflet material). For example, as shown in FIG. 3, exposed portions 222 of the frame 202 have an uncovered inner surface 224.

[0121] Thus, when crimped or radially compressed around the balloon 318, as shown in FIG. 6, the inner surface 224 of at least a portion of the apices 254 at the inflow end 210 of the frame 202 can directly contact the balloon 318. As a result, this may cause abrasion or degradation to the balloon 318, thereby resulting in reduced or inadequate inflation of the balloon 318 when attempting to deploy the prosthetic heart valve 200 at the implantation site.

[0122] FIGS. 7-12 show an assembled prosthetic heart valve 400 (FIGS. 7 and 12) and individual components of the prosthetic heart valve 400 (FIGS. 8-11), according to another example. FIGS. 13-25 show a method of assembling the components of the prosthetic heart valve 400 to form the assembled prosthetic heart valve 400. FIG. 26 is a cross-sectional view ofAttorney Docket No: THVVA-13343WO01 the prosthetic heart valve 400 radially compressed onto and around the balloon 318 of the delivery apparatus 300.

[0123] The prosthetic heart valve 400 can be similar to the prosthetic valve 200 of FIGS. 2 and 3. However, the prosthetic heart valve 400 is configured such that abrasion or degradation of the balloon is reduced or prevented when the prosthetic heart valve 400 is radially compressed onto the balloon of the delivery apparatus.

[0124] For example, the prosthetic heart valve 400 can comprise the frame 202 and the valvular structure 204 connected to the frame 202, as described above. The prosthetic heart valve 400 can have a central longitudinal axis 402 arranged through a center of an interior of the frame 202. The frame 202 of the prosthetic heart valve 400 is shown alone in FIG. 8. An exemplary leaflet 216 of the valvular structure 204 is shown in a flat (unfolded) configuration in FIG. 10 and an exemplary, folded configuration in FIG. 11. The folded configuration of the leaflet 216 shown in FIG. 11 can represent a form of the leaflet when attached to the frame 202, as described further below. An outer surface 482 of the leaflet 216, which faces the frame 202 after assembly to the frame 202, is shown in FIG. 11.

[0125] Each leaflet 216 can have a lower or cusp edge portion 416 (FIG. 10) that can be mounted to the frame 202 by a connecting skirt 410, as described further herein. During assembly to the frame 202, as described in further detail below, the lower cusp edge portion 416 can become folded toward the frame 202, as shown in FIGS. 11 and 12.

[0126] As shown in FIG. 10, the cusp edge portion 416 terminates at its upper ends at two laterally projecting integral lower tabs 418. As shown in FIG. 11, during assembly to the frame 12, the lower tabs 418 can fold over onto the outer surface 482. Projecting from the upper corners of the leaflet 216 are integral upper tabs 420 (also referred to as commissure tabs). The upper tabs 420 can be spaced from the lower tabs 418 by side edges 419 forming laterally extending gaps or recesses 417 in the leaflet 216. As described further below and shown in FIG. 11, the upper tabs 420 can be folded over on themselves to form commissures.Attorney Docket No: THVVA-13343WO01

[0127] In alternate examples, the leaflets of the valvular structure 204 can be configured differently that those shown in FIGS. 10 and 11, such as having differently shaped upper tabs or differently sized recesses 417.

[0128] As shown in FIG. 7, the prosthetic heart valve 400 includes a plurality of connecting skirts (e.g., members) 410 which connect the cusp edge portions 416 of the leaflets 216 to the frame 202 (e.g., in place of connecting skirts 260). For example, each connecting skirt 410 can secure the cusp edge portion 416 of one leaflet 216 to the frame 202. Thus, in the illustrated example, there are a plurality of discrete connecting skirts 410 (one for each leaflet 216) formed from separate pieces of material (e.g., separate pieces of fabric). In alternative examples, the prosthetic valve can have a single connecting skirt that is used for connecting all of the leaflets to the frame. The single connecting skirt can have different sections that are aligned along the cusp edge portions 416 of the leaflets 216.

[0129] The connecting skirts 410 include side portions 406 with extension portions 414 that cover the inner surface of the struts 208 (including apices 254) between adjacent leaflets 216, at the inflow end 210 of the frame 202 (FIG. 7). As a result, the inner surface of the apices 254 and struts 208 at the inflow end 210 of the frame 202 are covered and the connecting skirts 410 can serve as a barrier between the apices 254 and struts 208 and the balloon 318 when the prosthetic heart valve is radially compressed onto and around the balloon 318 (as described further below with reference to FIG. 26).

[0130] A single connecting skirt 410 of the prosthetic heart valve 400 is shown in FIG. 9. In some examples, the connecting skirt 410 can comprise a synthetic material, such as fabric (e.g., PET fabric), or a natural tissue material (e.g., pericardial tissue). In the illustrated example, a single connecting skirt 410 is provided for a cusp edge portion 416 of each leaflet 216 and is sized to extend along the entire length of the cusp edge portion 416 to locations just below lower tabs 418 of the leaflet 216 (FIG. 10).

[0131] FIG. 14 shows a connecting skirt 410 placed along an inner surface 480 of the cusp edge portion 416 of a leaflet 216 and attached to the cusp edge portion 416 of the leaflet 216. As shown in FIG. 9, the connecting skirt 410 can include a central portion 404 sized to extend over aAttorney Docket No: THVVA-13343WO01 central portion 413 of the cusp edge portion 416 of the leaflet 216 (e.g., central cusp edge portion 413) and two side portions 406 sized to extend over corresponding angled side edge portions 415 of the cusp edge portion 416 of the leaflet 216. As shown in FIG. 10, each angled side edge portion 415 can extend from the central portion 413 to a respective one of the lower tabs 418 of the leaflet 216.

[0132] Each side portion 406 of the connecting skirt 410 can include a base portion 412 (also referred to as a side base portion) and an extension portion 414 (also referred to as a side extension portion) which extends outwardly from the base portion 412. In some examples, as shown in FIG. 9, each extension portion 414 of the corresponding side portion 406 can be triangular. In some examples, the base portions 412 and the central portion 404 can be rectangular.

[0133] For example, each extension portion 414 can include a first angled edge 460 that extends outward, at an angle, from and relative to a free end 461 of the base portion 412 of the corresponding side portion 406. Each extension portion 414 can further include a perpendicular edge 462 that extends outward from an end of the base portion 412 that is connected to the central portion 404 of the connecting skirt 410. The perpendicular edge 462 can be parallel to the free end 461 of the base portion 412 of the corresponding side portion 406. The extension portion 414 can further include a second angled edge 463 that extends outward (e.g., away from the base portion 412), at an angle, from and relative to the perpendicular edge 462. The first angled edge 460 and the second angled edge 463 can meet at a point 465 that is spaced outward and away from the base portion 412. Thus, extension portions 414 of the side portions 406 extend outward and past the central portion 404 of the connecting skirt 410.

[0134] In some examples, an angle 459 between the first angled edge 460 and the second angled edge 463 can be in a range of about 45 degrees to about 120 degrees, about 75 degrees to about 100 degrees, or about 85 degrees to about 95 degrees.

[0135] Thus, due to the shape of the side portions 406 of the connecting skirt 410, the connecting skirt 410 can have a relatively straight first edge 471 (e.g., bottom edge in FIG. 9) extending across the central portion 404 and the two side base portions 412 and a non-straight second edgeAttorney Docket No: THVVA-13343WO01 469 (e.g., top edge in FIG. 9) extending from the free end 461 of one of the base portion 412 of the side portions 406 to the free end 461 of the other one of the base portions 412 of the side portions 406. The first edge 471 and the second edge 469 can be arranged opposite one another across the connecting skirt 410. Further, the second edge 469 can comprise multiple differently angled edges.

[0136] In some examples, together, the central portion 404 and the two base portions 412 can be referred to as a base portion of the connecting skirt and the two extension portions 414 can extend outwardly and away from the base portion.

[0137] The connecting skirt 410 can be formed with slits 408 partially separating the side portions 406 from the central portion 404 (FIG. 9) to facilitate alignment of the connecting skirt 410 along the cusp edge portion 416 of the leaflet 216, as shown in FIG. 14. For example, the slits 408 can be configured to allow the base portions 412 of the side portions 406 to bend (e.g., at an angle) relative to the central portion 404.

[0138] In alternative examples, plural connecting skirts can be provided for the cusp edge portion 416 of each leaflet 216 (e.g., the central portion 404 and the side portions 406 can be separate pieces of fabric). In another example, a single connecting skirt can be used to secure all of the leaflets 216 to the frame 202 (e.g., a single connecting skirt can be sized to extend along the cusp edge portions 416 of all of the leaflets 216 of the valvular structure 204).

[0139] In some examples, each connecting skirt 410 can include a plurality of apertures configured as suture holes that are configured to receive a stitch or suture for attaching the connecting skirt 410 to the leaflet 216 and / or the frame 202. For example, in some examples, the apertures can include a first row of apertures 484, a second row of apertures 486, a third row of apertures 488, and a fourth row of apertures 490 which each include a plurality of apertures spaced apart from one another along a length of the base portion 412 of each side portion 406 and the central portion 404 (FIGS. 9 and 13). In some examples, each extension portion 414 of the connecting skirt 410 can also include one or more apertures 492 (FIG. 9) that can be used to secure each extension portion 414 to another extension portion 414 of an adjacent connectingAttorney Docket No: THVVA-13343WO01 skirt 410 (e.g., as shown in FIG. 7). In some examples, the one or more apertures 492 are disposed in the extension portion, adjacent to (e.g., spaced apart along) the first angled edge 460.

[0140] FIGS. 12-25 show assemblies and methods for assembling the valvular structure 204 to the frame 202, including methods for attaching the connecting skirts 410 to their respective leaflets 216 (FIGS. 13-16), methods for forming the valvular structure 204 (FIG. 17), methods for attaching the connecting skirts 410 to the frame 202 (FIGS. 19-21), and methods for forming commissures and attaching the commissures to the frame 202 (FIGS. 23-25).

[0141] To attach a connecting skirt 410 to a corresponding leaflet 216, the base portions 412 of the side portions 406 and the central portion 404 can first be folded over on themselves (e.g. in half), as illustrated by the arrows 494 in FIG. 13. For example, as shown in the cross-sectional view of FIG. 12, folding the base portions 412 and the central portion 404 lengthwise (as shown in FIG. 13) can form two fold layers 464a, 464b, with the extension portions 414 extending outward from one of the two fold layers (e.g., fold layer 464b in FIG. 12).

[0142] The folded base portions 412 and central portion 404 can then be arranged along the inner surface 480 of the cusp edge portion 416 of the leaflet 216 (FIG. 14). For example, as introduced above and as shown in FIG. 14, the folded central portion 404 can be positioned over the central portion 413 of the cusp edge portion 416 of the leaflet 216 and each base portion 412 can be positioned over a corresponding angled side edge portion 415 of the cusp edge portion 416 of the leaflet 216.

[0143] As shown in FIG. 14, in some examples, adjacent portions of the central portion 404 and each of the base portions 412 can overlap in a region of the slits 408 due to the bending of the base portions 412 relative to the central portion 404, which is facilitated by the slits 408.

[0144] The extension portions 414 of the side portions 406 of the connecting skirt 410 extend away from the cusp edge portion 416 and across a portion of the inner surface 480 of the leaflet 216. In some examples, as shown in FIG. 14, the two extension portions 414 of the connecting skirt 410 overlap one another in a region of their points 465.Attorney Docket No: THVVA-13343WO01

[0145] After placing the connecting skirt 410 on the inner surface 480 of the leaflet 216, as shown in FIG. 14, the folded base portions 412 and central portion 404 can be secured to the cusp edge portion 416. For example, the folded base portions 412 and central portion 404 can be secured to the cusp edge portion 416 via one or more sutures (e.g., stitching) 468 that form a stitching line 467 along the cusp edge portion 416 (FIGS. 12 and 14). In some examples, the stitching line 467 can comprise a plurality of in and out stitches that extend through the cusp edge portion 416 of the leaflet 216 and overlapping apertures of the second row of apertures 484 and the third row of apertures 488 of the connecting skirt 410. For example, when the base portions 412 and the central portion 404 of the connecting skirt 410 are folded as described above and shown in FIG. 14, the two middle rows of apertures (e.g., the second row of apertures 486 and the third row of apertures 488 shown in FIG. 13) can overlap one another, thereby forming a single row of double-layered apertures configured to receive the in and out stitches of the one or more sutures 468.

[0146] While FIG. 14 shows the inner surface 480 of the leaflet 216, FIG. 15 shows the opposite, outer surface 482 of the leaflet 216. Since the connecting skirt 410 is behind the leaflet 216 in the view of FIG. 14, the edges of the connecting skirt 410 are illustrated with dashed lines. The stitching line 467 formed by the one or more sutures 468 can be seen on the outer surface 482 of the leaflet 216 (FIG. 15).

[0147] Together, the leaflet 216 and attached connecting skirt 410, as shown in FIGS. 14 and 15, can form and be referred to herein as a leaflet assembly 485.

[0148] In some examples, a reinforcing member or chord 466 (e.g., an Ethibond suture) can be placed against the outer surface 482 of the cusp edge portion 416, opposite the connecting skirt 410 (FIG. 16). The reinforcing chord 466 and the fold layers 464a, 464b can be sutured to each other and to the cusp edge portion 416 with stitching 474, which can be a single suture or multiple sutures extending through one or more layers of material (FIG. 12).

[0149] In some examples, when suturing the reinforcing chord 466 to the leaflet 216, the lower tabs 418 can be folded downwardly against the cusp edge portion 416 (see FIG. 16) and the reinforcing chord 466 can be placed over the folded lower tab 418. The upper ends of theAttorney Docket No: THVVA-13343WO01 connecting skirt 410 can be sized to extend over the folded lower tabs 418. Stitching 474 can be used to secure the reinforcing chord 466 in place against the folded lower tab 418 (FIG. 12).

[0150] In some examples, a single reinforcing chord 466 can extend continuously along the cusp edge portions 416 of all of the leaflets 216 of the valvular structure 204 and through the spaces beneath each commissure 498. In other examples, plural reinforcing chords 466 can be used, with one reinforcing chord secured to the cusp edge portion of each leaflet 216. Where multiple reinforcing chords 466 are used, the ends of each chord can be connected (e.g., by tying or knotting) to adjacent ends of the other chords. For example, adjacent ends of two chords can be connected to each in the space underneath a commissure.

[0151] After each connecting skirt 410 is secured to each respective leaflet 216, forming a leaflet assembly 485, the leaflet assemblies 485 (e.g., three shown in FIG. 17) can be secured together to form the valvular structure 204, as shown in FIG. 17. Though the valvular structure 204 comprises three leaflets 216 and leaflet assemblies 485, in alternate examples, a leaflet structure for the prosthetic valves discussed herein can have a different number of leaflets, such as two leaflets.

[0152] As shown in FIG. 17, the three leaflet assemblies 485 are arranged together, in a flat configuration, with the cusp edge portions 416 of the leaflets 216 forming an outer perimeter of the valvular structure 204 and with upper tabs 420 from adjacent leaflets 216 folded upward and positioned against one another. The three leaflet assemblies 485 can be secured (e.g., sutured or otherwise fastened) together via one or more sutures 422 (FIGS. 14 and 15) that form a stitching line 424 along and between each of the cusp edge portions 416 of each leaflet 216 (FIG. 17).

[0153] In some examples, one or more tails 425 of the one or more sutures 422 can be connected to struts 208 of the frame 202.

[0154] Once the leaflet assemblies 485 are secured together, the valvular structure 204 can be arranged within an interior of the frame 202 and secured to the frame 202, as shown in FIGS. 7, 12, and 19-24.Attorney Docket No: THVVA-13343WO01

[0155] To secure the cusp edge portions 416 of each leaflet 216 of the valvular structure 204 to the frame 202, the folded over central portion 404 and base portions 412 of each connecting skirt 410 can be secured (e.g., sutured) to struts 208 of the frame 202. In some examples, one or more sutures 470 (forming stitches) can extend through the folded over central portion 404 and base portions 412 of each connecting skirt 410 and around struts 208 of the frame 202, along a length of the cusp edge portions 416 to secure the cusp edge portions 416 of the leaflets 216 to the frame 202 (FIGS. 19 and 20).

[0156] For example, FIGS. 19 and 20 show detail views of the one or more sutures 470 securing the connecting skirts 410 to the struts 208 of the frame 202 from the perspective of an interior of the frame 202 (FIG. 19) and an exterior of the frame 202 (FIG. 20). As explained above, when the central portion 404 and base portions 412 of each connecting skirt 410 are folded over, as shown in FIGS. 19 and 20, the first row of apertures 484 and the fourth row of apertures 490 (FIGS. 9 and 13) of the connecting skirt 410 can overlap one another and form a single row of apertures configured to receive the stitches of the one or more sutures 470 (FIGS. 19 and 20). The overlapping apertures are numbered in FIGS. 19 and 20 to show a correspondence between the inner surface (FIG. 19) and the outer surface (FIG. 20) of the connecting skirt 410.

[0157] In some examples, the one or more sutures 470 can extend through the folded over portions of the connecting skirt 410, around a strut 208 (as shown from the exterior view of FIG. 20), and then back through the connecting skirt 410 to an interior surface of the frame 202 (as shown in FIG. 19). These stitches can repeat along a length of the central portion 404 and base portions 412 of each connecting skirt 410 (e.g., along the cusp edge portions 416 of the leaflets 216), thereby connecting each connecting skirt 410 to a first set or portion of struts 208 that extend at an angle from a first commissure 498 to the inflow end 210 and from the inflow end to a second commissure 498 (FIGS. 7 and 22).

[0158] In some examples, the stitches formed by the one or more sutures 470 can comprise a plurality of whip stitches. In some examples, individual stitches 472 can secure each connecting skirt 410 to corresponding strut junctions 256 (FIGS. 7 and 20). Thus, in some examples, the two fold layers 464a and 464b of each connecting skirt 410 can be secured to strut junctions 256Attorney Docket No: THVVA-13343WO01 by individual stitches 472 and whip stitches of the one or more sutures 470 that are formed along the length of a struts 208 between two strut junctions 256, as shown in FIGS. 7 and 12.

[0159] In some examples, the whip stitches of the one or more sutures 470 optionally can extend through the cusp edge portion 416 of the leaflets 216.

[0160] In some examples, attaching the connecting skirt 410 to the frame 202, as described above, can cause the cusp edge portion 416 of the leaflet 216 to fold over itself, toward the frame 202, as shown in FIGS. 11, 12, and 18. As a result, the inner surface 480 of the cusp edge portion 416 now faces an inner surface of the frame 202. Further, as a result of this folding, the fold layer 464a of the connecting skirt 410 faces the inner surface of the frame 202 (FIGS. 12 and 18) and the extension portions 414 of the connecting skirt 410 are folded away from the inner surface 480 of the leaflet 216 and toward the inner surface of the frame 202 (FIGS. 12 and 18). For example, FIG. 18 is an exploded, perspective view of a leaflet 216 and a connecting skirt 410, as they would appear when attached to the frame 202.

[0161] As a result of the folding over of the cusp edge portion 416 of the leaflet 216 as it is attached to the frame 202, the extension portions 414 can cover a second set or portion of struts 208 and apices 254 of the frame 202 that are arranged at the inflow end 210, between cusp edge portions 416 of adjacent leaflets 216 (FIGS. 7, 19, and 20).

[0162] In some examples, portions of two adjacent extension portions 414 of two adjacent connecting skirts 410 overlap one another, thereby forming overlapping extension portions 476. As shown in FIGS. 7, 21, and 22, in some examples, the overlapping extension portions 476 can be secured together via one or more sutures 478 (or other similar fasteners or fastening members), thereby securing two extension portions 414 of two adjacent connecting skirts 410 to one another. In some examples, the extension portions 476 can be secured to struts of the frame 202, such as a strut junction 256 which the extension portions 476 overlay, by the sutures 478 or by additional sutures.

[0163] FIG. 21 is a perspective, detail view of inner surfaces of the extension portions 414 of two adjacent connecting skirts 410 and the inner surfaces 480 of two adjacent leaflets 216 (e.g., from the inside of the valve and frame 202). In contrast, FIGS. 7 and 22 show an exterior viewAttorney Docket No: THVVA-13343WO01 of the prosthetic heart valve 400 and outer surfaces of the extension portions 414 of the connecting skirts 410.

[0164] As shown in FIG. 21, the extension portions 414 of the connecting skirts 410 extend over and cover the inner surfaces of the struts 208 and apices 254 arranged between adjacent leaflets 216 at the inflow end 210 of the frame 202. As a result, the connecting skirts 410 are disposed between the frame 202 and an interior 496 of the prosthetic heart valve 400 (FIGS. 12 and 22).

[0165] Thus, when the prosthetic heart valve 400 is radially compressed around and onto an inflatable balloon of a delivery apparatus (e.g., balloon 318), as shown in FIG. 26, the material of the connecting skirts 410 is positioned between the apices 254 of the frame 202 and the balloon 318, thereby serving as a protective barrier between the struts 208 of the frame 202 and the balloon 318. As a result, degradation to the balloon can be reduced and / or prevented.

[0166] The valvular structure 204 can be further secured to the frame 202 by forming commissures 498 and mounting them to the frame 202, as shown in the exemplary method presented at FIGS. 23-35. As introduced above and shown in FIG. 10, each leaflet 216 can include lower tabs 418 and upper tabs 420 (also referred to as commissure tabs). The upper tabs 420 can be spaced from the lower tabs 418 by side edges 419 forming laterally extending gaps or recesses 417 in the leaflet.

[0167] As shown in FIGS. 10 and 16, each upper tab 420 can be folded along a fold line 423 to form first and second tab layers 420a and 420b. The upper tab 420 can be secured to a commissure attachment member 431, along with the upper tab 420 of an adjacent leaflet to form a commissure 498, as further described below. FIG. 23 shows a commissure attachment member 431 in a flattened configuration prior to folding and attachment to the leaflets. Each commissure attachment member 431 in the illustrated configuration comprises first and second side portion 428a, 428b projecting laterally from a central portion 430. As shown, the outer peripheral edges 432 of the side portions 428a, 428b can be shaped to correspond to one half of a diamond-shaped cell 214 of the frame 202 to facilitate mounting of the commissure attachment member 431 to the struts 208 of the frame 202, as described further below.Attorney Docket No: THVVA-13343WO01

[0168] Referring to FIGS. 24 and 25, after the upper tab 420 of a leaflet 216 is folded, a vertical reinforcement member 426 can be secured to the inner surface of tab layer 420a, such as with stitching. The folded tab layers 420a, 420b can be secured to a side portion 428a or 428b of the commissure attachment member 431. The folded tab layers 420a, 420b also can be folded along a vertical fold line at the reinforcement member 426 in an L-shape such that the tab layer 420b forms a first circumferentially extending layer 434a and a first radially extending layer 434b that is generally perpendicular to the layer 434a and the tab layer 420a forms a second inner circumferentially extending layer 436a and a radially extending layer 436b that is generally perpendicular to the layer 436a. Another upper tab 420 of an adjacent leaflet 216 can be similarly folded and secured to the other side portion 428a or 428b of the commissure attachment member 431.

[0169] The commissure attachment member 431 can be folded as shown in FIG. 25 to form an inner layer 438 and two intermediate layers 440 and two outer layers 442. Each folded upper tab 420 can be secured to the inner layer 438 and an intermediate layer 440 with stitching 444. In the illustrated example, stitching 444 is shown extending through the reinforcement member 426, a layer 436a, a layer 434a, a layer 438, and a layer 440. However, during the assembly process, multiple stitches can be employed to secure each layer to an adjacent layer as each folded is created. For example, layers 434a, 436a can be secured to each other and a reinforcement member 426 with separate stitching, and additional stitching can then be used to secure the leaflet layers to the inner layer 438 of the commissure attachment member 431, and further stitching can be used to secure an intermediate layer 440 to the inner layer 438. As best shown in FIG. 25, the commissure attachment member 431 can be folded to leave a small gap 446 between the outer layers 442.

[0170] The outer layers 442 can be secured to the frame 12, such as by suturing the outer peripheral edges 432 to struts 208 with stitching 448 (FIGS. 24 and 25). As mentioned above, the outer peripheral edges 432 of the commissure attachment member 431 can generally correspond to the shape of a closed cell of the frame 202. For example, as shown in FIG. 8, the frame 202 in the illustrated example comprises a plurality of generally diamond-shaped cells 214, each of which is formed by struts 208a, 208b, 208c, and 208d. Stitching 448 can be used toAttorney Docket No: THVVA-13343WO01 suture the outer peripheral edges 432 of the commissure attachment member 431 to struts 208a, 208b, 208c, and 208d forming a closed cell 214. The commissure attachment member 431 can further include an upper tab 450 and a lower tab 452 projecting from the upper and lower edges of the central portion (FIG. 23). Stitching 448 can also be used suture the upper tab 450 an apex 254 formed by the intersection of struts 208a, 208c and to suture the lower tab 452 to a strut junction 256 formed by the intersection of struts 208b, 208d (FIGS. 7 and 8).

[0171] Additional details regarding the method for forming commissures 498 and securing them to the frame 202 of the prosthetic heart valve are described in U.S. Patent Publication No. 2018 / 0028310, which is incorporated by reference herein.

[0172] In some examples, after securing the valvular structure 204 to the frame 202, as described above, an outer sealing member 454 can be mounted around an outer surface 456 of the frame 202 (FIGS. 12 and 22). For example, as shown in FIG. 22 by arrow 457, the outer sealing member 454 can be slid over the exterior of the frame 202 to cover at least a portion of the connecting skirts 410 arranged on the inside of the frame 202. In some examples, as shown in FIG. 12, the outer sealing member 454 can then be 458 secured to the outer surface 456 of the frame 202 and the connecting skirts 410 via one or more sutures 458 (or other fastening members). As an example, FIG. 22 shows a dashed outline 495 around a portion of struts and the connecting skirts 410 to which the outer sealing member 454 can be secured via the one or more sutures 458. In some examples, additional sutures or fasteners can secure portions of the outer sealing member 454 directly to struts 208 of the frame 202 (e.g., top and bottom portions or edges of the outer sealing member 454).

[0173] In this way, leaflets of a valvular structure can be attached to a frame of a prosthetic heart valve using one or more connecting skirts. For example, a central portion and side base portions of a connecting skirt can be secured directly to a cusp edge portion of a corresponding leaflet and the central portion and side base portions of the connecting skirt can be secured directly to struts of the frame, thereby securing the attached leaflet to the frame. Each connecting skirt can further include side extension portions that extend across struts of the frame that are disposed between cusp edge portions of adjacent leaflets (e.g., when the valvular structure is attached to the frame,Attorney Docket No: THVVA-13343WO01 as described above). As a result, the side extension portions of the connecting skirts can cover inner surfaces of the struts and apices at the inflow end of the frame that are otherwise uncovered by the leaflets. Thus, when the prosthetic heart valve is radially compressed onto and around an inflatable balloon of a delivery apparatus, the extension portions of the connecting skirts can serve as a protective barrier between the balloon and apices and struts of the frame. As a result, a longevity and effectiveness (e.g., ability to inflate) of the balloon can be increased.

[0174] FIG. 27 is a cross-sectional view of a portion of a prosthetic heart valve (for example, prosthetic valve 150, 200 or 400) showing the connection of a cusp edge portion of a leaflet 216 to the frame (for example, frame 202) of the prosthetic heart valve with a connecting skirt 500, according to another example. The frame 202 of the prosthetic heart valve comprises a plurality of struts forming cells defining openings in the frame around the circumference of the frame, as previously described herein. The prosthetic valve of FIG. 27 can include a plurality of leaflets 216 connected to the frame with the connecting skirt 500.

[0175] As shown in the example of FIG. 27, the connecting skirt 500 is oriented in the opposite direction compared to the connecting skirt 410 of FIG. 12. The connecting skirt 500 in this example is folded along a fold 508, creating two depending skirt layers 506a and 506b. The fold 508 is situated toward the inflow end of the valve frame while the skirt layers extend toward the outflow end of the frame. The skirt 500 is secured to adjacent frame struts 208 with stitches 504 forming a first stitch line adjacent the fold 508 of the skirt. For example, the stitches 504 can form a plurality of whip stitches extending through layers 506a, 506b and around adjacent struts 208, similar to whip stitches 472. In other examples, the connecting skirt 500 can be single layer of material without a fold.

[0176] Further in this example, a cusp edge portion 416 of leaflet 216 is folded upward toward the outflow end of the frame. The folded connecting skirt 500 is positioned against the inner surface (also referred to herein as “inflow surface”) 480 of the folded cusp edge portion 416 and secured thereto using stitches 502 forming a second stitch line, which is positioned along the cusp edge and parallel to the first stitch line around the circumference of the frame.Attorney Docket No: THVVA-13343WO01

[0177] A reinforcing member or chord 466 is secured to the outer surface (also referred to herein as “outflow surface”) 482 of the cusp edge portion 416 of each leaflet along a bending axis, opposite this connecting skirt 500. The reinforcing chord 466 can be sutured to the cusp edge portion 416 and the fold layers 506a, 506b with stitches 502 along the second stitch line. The second stitch line can be a plurality of in-and-out stitches 502, wherein the stitches extend through the reinforcing member 466, the cusp edge portion 416, and layers 506a, 506b of the skirt 500, similar to stitches 474. The second stitch line is axially offset from the first stitch line (formed from stitches 504) toward the outflow end of the frame by a distance d1.

[0178] In some patients that receive a prosthetic heart valve, it may be necessary to access the coronary arteries with a catheter (or another medical instrument) in a subsequent procedure. Typically, this is accomplished by advancing the catheter through the aorta and into the prosthetic heart valve, and then laterally through the frame of the prosthetic heart valve and into a coronary artery. Thus, it is desirable to maximize the available space through the cells of the frame in the area of the coronary ostia for subsequent artery access.

[0179] FIG. 28 is a cross-sectional view of a portion of a prosthetic heart valve (for example, prosthetic valve 150, 200 or 400) according to another example, showing an alternative connection between a cusp edge portion 416 of a leaflet 216 to a frame (for example, frame 202) of the prosthetic heart valve using a connecting skirt 600. The prosthetic valve of FIG. 28 can include a plurality of leaflets 216 connected to the frame with the connecting skirt 600.

[0180] Unlike the example of FIG. 27, the folded connecting skirt 600 in FIG. 28 is positioned with a fold 608 oriented toward the outflow end of the frame and includes layers 606a and 606b extending from the fold 608 toward the inflow end of the frame. The folded connecting skirt 600 is secured to adjacent struts 208 with a plurality of stitches 604 forming a first stitch line adjacent the fold 608 of the skirt. For example, the stitches 604 can be a plurality of whip stitches that extend through the layers 606a, 606b of the skirt and around adjacent struts, similar to whip stitches 472. The first stitch line is an undulating stitch line that extends along adjacent struts 208 in multiple rows of struts and tracks the curvature of the outflow edge of the skirt 600 andAttorney Docket No: THVVA-13343WO01 the cusp edge portions 416 of the leaflets 216 around the circumference of the frame. In other examples, the connecting skirt 600 can be single layer of material without a fold.

[0181] Similar to the leaflet shown in FIG. 27, the cusp edge portion 416 of the leaflet 216 of FIG. 28 is folded or bent upward toward the outflow end the frame. A reinforcing member or chord 466 is secured along the outflow surface 482 of the cusp edge portion 416 of each leaflet along a bending axis. The folded connecting skirt 600 of this example is secured against the inflow surface 480 of the folded cusp edge portion 416 using a plurality of stitches 602 forming a second stitch line along the cusp edge, wherein the second stitch line is parallel or substantially parallel to the first stitch line around the circumference of the frame. The second stitch line formed from stitches 602 can extend along the cusp edge portion 416 of each leaflet 216 of the prosthetic valve. The stitches 602 can be in-and-out stitches that extend through the reinforcing member 466, the cusp edge portion 416, and the layers 606a, 606b of the skirt 600. The second stitch line defined by stitches 602 in FIG. 28 is shown axially offset from struts 208 and the first stitch line toward the inflow end along the connecting skirt 600. The reinforcing member is secured to the connecting skirt 600 and the folded leaflet cusp edge using these stitches 602 along this second stitch line.

[0182] In contrast to the example shown in FIG. 27, the second stitch line formed by stitches 602 is axially offset from the first stitch line formed by stitches 604 toward the inflow end of the frame by an offset distance d2. The offset distance d2 is defined as the distance from the centerline of the reinforcing member 466 to the midline of the struts 208 around which the stitches 604 extend. In some examples, this offset distance d2 is between 0.5-0.8 mm, however the distance can be adjusted as needed for a particular application.

[0183] The resulting stitched structure shown in the example of FIG. 28 positions the reinforcing member 466 and the majority of the cusp edge portion 416 and the skirt 600 upstream of the line of struts 208 that are connected to the skirt. In some examples, the entirety of the skirt 600 and the cusp edge portion 416 are upstream of the line of struts 208 connected to the struts. Advantageously, offsetting the second stitch line upstream of the first stitch line minimizes the extent the skirt and the cusp edge portion of the leaflets extend across open cells of the frameAttorney Docket No: THVVA-13343WO01 downstream of the skirt and the cusp edge portions of the leaflets. Therefore space through the cells of the frame downstream of the line of struts 208 that can be used for accessing the coronary arteries in a subsequent procedure and blood flow to the coronary arteries are maximized.

[0184] FIG. 29 is a cross-sectional view of a portion of a prosthetic heart valve (for example, prosthetic valve 150, 200 or 400) according to another example, showing a valve leaflet 700 with a leaflet cusp edge portion 716 and a frame (for example, frame 202) with struts 208. In this example, the leaflet cusp edge portion 716 is not folded. The leaflet 700 comprises an inflow surface 780 and an outflow surface 782. Unlike the cusp edge portion 416 depicted in FIG. 28 which extends toward the outflow end of the frame, the cusp edge portion 716 shown in FIG. 29 extends toward the inflow end of the frame. A reinforcing member 466 can be secured along the inflow surface 780 of the valve cusp edge portion 716 using a plurality of stitches 602.

[0185] FIG. 29 also shows a folded connecting skirt 600 oriented with a fold 608 toward the outflow end of the frame. Skirt 600 includes layers 606a and 606b extending from the fold 608 toward the inflow end of the frame. The folded connecting skirt 600 is secured to adjacent struts 208 with a plurality of stitches 604 forming a first stitch line adjacent the fold 608 of the skirt. The skirt 600, the stitches 604, and the first stitch line of FIG. 29 can have the same configuration, construction, and assembly as the connecting skirt 600 of FIG. 28 and are given the same reference numbers. Therefore, the description of the skirt 600 in FIG. 28 is incorporated herein and applies to the skirt 600 shown in FIG. 29. The prosthetic valve of FIG. 29 can include a plurality of leaflets 700 connected to the frame with the connecting skirt 600. In some examples, the skirt 600 can comprise a single layer of material without a fold.

[0186] The outflow surface 782 of the valve cusp edge portion 716 is positioned against the inner layer 606b of the connecting skirt 600 and secured thereto also using stitches 602, wherein stitches 602 form a second stitch line along the cusp edge portion 716. The stitches 602 can be in-and-out stitches that extend through the reinforcing member 466, the cusp edge portion 716, and the layers 606a, 606b of the skirt 600, thereby securing the reinforcing member 466, the leaflet 700, and the connecting skirt 600 together. The second stitch line defined by stitches 602Attorney Docket No: THVVA-13343WO01 in FIG. 29 is shown axially offset from struts 208 and the first stitch line toward the inflow end along the connecting skirt 600. The reinforcing member 466 is secured to the connecting skirt 600 and the leaflet cusp edge portion 716 using these stitches 602 along this second stitch line.

[0187] Similar to the example shown in FIG. 28, the second stitch line formed by stitches 602 is axially offset from the first stitch line formed by stitches 604 toward the inflow end of the frame by an offset distance d2 previously defined in the example of FIG. 28, wherein d2 is once again optimized to maximize the exposed area through the frame cells downstream of the skirt and the cusp edge portions of the leaflets, providing improved coronary access and blood flow to the coronary arteries.

[0188] The resulting stitched structure shown in the example of FIG. 29 positions the reinforcing member 466, the entirety of the cusp edge portion 716, and the majority or the entirety of skirt 600 upstream of the line of struts 208 that are connected to the skirt. By offsetting the second stitch line upstream of the first stitch line, the extent the skirt and the cusp edge portion of the leaflets extend across open cells of the frame is minimized, thereby maximizing space through the cells of the frame downstream of the line of struts 208 for increased access to the coronary arteries in a subsequent procedure.

[0189] In the prosthetic valves of FIGS. 27-29, the depicted connecting skirt (connecting skirt 500 or 600) can be single, continuous piece of material that connects each leaflet to the frame of the prosthetic valve around the circumference of the frame. For example, the connecting skirt 600 can be a single piece of material that is stitched to each leaflet 216 (or leaflet 700) of the prosthetic valve with stitches 602 and to adjacent struts 208 of the frame 202 with stitches 604. In other examples, the connecting skirt 500, 600 can comprise a plurality of discrete or individual pieces of material for connecting respective leaflets 216 (or leaflets 700) to the frame 202, similar to connecting skirts 410. For example, the connecting skirt 500, 600 can comprise a plurality of skirt sections, each of which is stitched to a respective leaflet 216 (or leaflet 700) with stitches 602, and to adjacent struts 208 of the frame 202 with stitches 604, wherein the skirt sections together form the connecting skirt 500, 600.Attorney Docket No: THVVA-13343WO01

[0190] In some examples, the connecting skirts 500, 600 can have any of the features described above for connecting skirts 410. Sterilization

[0191] 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. Delivery Techniques

[0192] 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 (e.g., 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) are 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.Attorney Docket No: THVVA-13343WO01

[0193] 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.

[0194] 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.

[0195] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.Attorney Docket No: THVVA-13343WO01

[0196] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art. Additional Examples of the Disclosed Technology

[0197] 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. Example 1. A prosthetic heart valve, comprising: a radially expandable and compressible frame having an inflow end and an outflow end, the frame comprising a plurality of struts defining openings between them; a valvular structure comprising a plurality of leaflets, each leaflet comprising a coaptation edge portion and a cusp edge portion; a connecting skirt disposed between the cusp edge portions of the leaflets and the frame; wherein the connecting skirt is secured to the frame with first stitches to adjacent struts to form a first stitch line; and wherein the cusp edge portion of each leaflet is stitched to the connecting skirt with second stitches along a second stitch line that is parallel to and axially offset from the first stitch line toward the inflow end of the frame.

[0198] Example 2. The prosthetic heart valve of any example herein, particularly example 1, wherein the second stitch line is offset from the first stitch line by a distance that is constant around a circumference of the frame.

[0199] Example 3. The prosthetic heart valve of any example herein, particularly any preceding example, wherein the connecting skirt is folded to form an inner layer, an outer layer, and a fold, and wherein the fold is oriented toward the outflow end of the frame such that both inner and outer layers extend from the fold toward the inflow end of the frame.Attorney Docket No: THVVA-13343WO01

[0200] Example 4. The prosthetic heart valve of any example herein, particularly example 3, wherein each of the first stitches and the second stitches extend through the inner and outer layers of the connecting skirt.

[0201] Example 5. The prosthetic heart valve of any example herein, particularly any preceding example, comprising a reinforcing member extending along an inflow surface of the cusp edge portion of each leaflet and axially offset from the first stitch line toward the inflow end of the frame.

[0202] Example 6. The prosthetic heart valve of any example herein, particularly example 5, wherein the reinforcing member is stitched to the cusp edge portion of each leaflet and the connecting skirt with the second stitches along the second stitch line.

[0203] Example 7. The prosthetic heart valve of any example herein, particularly any one of examples 1-4, wherein the cusp edge portion of each leaflet is folded toward the outflow end of the frame along a bending axis and comprises a reinforcing member extending along an outflow surface of the cusp edge portion of each leaflet along the bending axis, wherein the reinforcing member is axially offset from the first stitch line toward the inflow end of the frame.

[0204] Example 8. The prosthetic heart valve of any example herein, particularly example 7, wherein the reinforcing member is stitched to the cusp edge portion of each leaflet and the connecting skirt with the second stitches along the second stitch line.

[0205] Example 9. The prosthetic heart valve of any example herein, particularly any preceding example, wherein the first stitch line is axially offset from the second stitch line by 0.5-0.8 mm.

[0206] Example 10. A prosthetic heart valve, comprising: a radially expandable and compressible frame having an inflow end and an outflow end, the frame comprising a plurality of struts defining openings between them; a valvular structure comprising a plurality of leaflets, each leaflet comprising a coaptation edge portion and a cusp edge portion, the cusp edge portion of each leaflet being folded toward the outflow end of the frame along a bending axis; a reinforcing member extending along an outflow surface of the cusp edge portion of each leaflet along the bending axis; and a connecting skirt disposed between the cusp edge portions of theAttorney Docket No: THVVA-13343WO01 leaflets and the frame; wherein the connecting skirt is connected to the frame with first stitches to adjacent struts to form a first stitch line; and wherein the cusp edge portions of the leaflets are stitched to the connecting skirt with second stitches along a second stitch line that is axially offset from the first stitch line toward the inflow end of the frame.

[0207] Example 11. The prosthetic heart valve of any example herein, particularly example 10, wherein the second stitch line is offset from the first stitch line by a distance that is constant around a circumference of the frame.

[0208] Example 12. The prosthetic heart valve of any example herein, particularly any one of examples 10-11, wherein the connecting skirt is folded to form an inner layer, an outer layer, and a fold, and wherein the fold is oriented toward the outflow end of the frame such that both inner and outer layers extend from the fold toward the inflow end of the frame.

[0209] Example 13. The prosthetic heart valve of any example herein, particularly example 12, wherein each of the first stitches and the second stitches extend through the inner and outer layers of the connecting skirt.

[0210] Example 14. The prosthetic heart valve of any example herein, particularly any one of examples 10-13, wherein the reinforcing member is axially offset from the first stitch line toward the inflow end of the frame.

[0211] Example 15. The prosthetic heart valve of any example herein, particularly example 14, wherein the reinforcing member is axially offset from the first stitch line by 0.5-0.8 mm.

[0212] Example 16. The prosthetic heart valve of any example herein, particularly any of examples 10-15, wherein the reinforcing member is stitched to the cusp edge portion of each leaflet and the connecting skirt with the second stitches along the second stitch line.

[0213] Example 17. A method of assembling a prosthetic heart valve comprising a frame and a plurality of leaflets, the method comprising: stitching a connecting skirt to adjacent struts of the frame with a plurality of first stitches to form a first stitch line; and stitching the connecting skirt to cusp edge portions of the leaflets with a plurality of second stitches to form a second stitchAttorney Docket No: THVVA-13343WO01 line, which is parallel to and axially offset from the first stitch line toward an inflow end of the frame.

[0214] Example 18. The method of any example herein, particularly example 17, wherein the second stitch line is offset from the first stitch line by a distance that is constant around a circumference of the frame.

[0215] Example 19. The method of any example herein, particularly any one of examples 17- 18, comprising: folding the cusp edge portion of each leaflet toward an outflow end of the frame along a bending axis; and securing a reinforcing member along an outflow surface of the cusp edge portion of each leaflet along the bending axis.

[0216] Example 20. The method of any example herein, particularly example 19, wherein the reinforcing member is axially offset from the first stitch line by 0.5-0.8 mm.

[0217] Example 21. The method of any example herein, particularly any one of examples 19- 20, wherein securing the reinforcing member to the cusp edge portion of each leaflet comprises stitching the reinforcing member to the cusp edge portion of each leaflet and the connecting skirt with the second stitches along the second stitch line.

[0218] Example 22. The method of any example herein, particularly any one of examples 17- 18, comprising securing a reinforcing member along an inflow surface of the cusp edge portion of each leaflet in a position axially offset from the first stitch line toward the inflow end of the frame.

[0219] Example 23. The method of any example herein, particularly example 22, wherein the reinforcing member is axially offset from the first stitch line by 0.5-0.8 mm.

[0220] Example 24. The method of any example herein, particularly any one of examples 22- 23, wherein securing the reinforcing member to the cusp edge portion of each leaflet comprises stitching the reinforcing member to the cusp edge portion of each leaflet and the connecting skirt with the second stitches along the second stitch line.

[0221] Example 25. A prosthetic heart valve of any example herein, particularly examples 1- 24, wherein the prosthetic heart valve is sterilized.Attorney Docket No: THVVA-13343WO01

[0222] Example 26. A method comprising sterilizing the prosthetic heart valve, apparatus, and / or assembly of any example.

[0223] In view of the many possible examples to 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. I therefore claim all that comes within the scope and spirit of these claims.

Claims

Attorney Docket No: THVVA-13343WO01 CLAIMS:

1. A prosthetic heart valve, comprising: a radially expandable and compressible frame having an inflow end and an outflow end, the frame comprising a plurality of struts defining openings between them; a valvular structure comprising a plurality of leaflets, each leaflet comprising a coaptation edge portion and a cusp edge portion; a connecting skirt disposed between the cusp edge portions of the leaflets and the frame; wherein the connecting skirt is secured to the frame with first stitches to adjacent struts to form a first stitch line; and wherein the cusp edge portion of each leaflet is stitched to the connecting skirt with second stitches along a second stitch line that is parallel to and axially offset from the first stitch line toward the inflow end of the frame.

2. The prosthetic heart valve of claim 1, wherein the second stitch line is offset from the first stitch line by a distance that is constant around a circumference of the frame.

3. The prosthetic heart valve of any preceding claim, wherein the connecting skirt is folded to form an inner layer, an outer layer, and a fold, and wherein the fold is oriented toward the outflow end of the frame such that both inner and outer layers extend from the fold toward the inflow end of the frame.

4. The prosthetic heart valve of claim 3, wherein each of the first stitches and the second stitches extend through the inner and outer layers of the connecting skirt.

5. The prosthetic heart valve of any preceding claim, comprising a reinforcing member extending along an inflow surface of the cusp edge portion of each leaflet and axially offset from the first stitch line toward the inflow end of the frame.Attorney Docket No: THVVA-13343WO01 6. The prosthetic heart valve of claim 5, wherein the reinforcing member is stitched to the cusp edge portion of each leaflet and the connecting skirt with the second stitches along the second stitch line.

7. The prosthetic heart valve of any of claims 1-4, wherein the cusp edge portion of each leaflet is folded toward the outflow end of the frame along a bending axis and comprises a reinforcing member extending along an outflow surface of the cusp edge portion of each leaflet along the bending axis, wherein the reinforcing member is axially offset from the first stitch line toward the inflow end of the frame.

8. The prosthetic heart valve of claim 7, wherein the reinforcing member is stitched to the cusp edge portion of each leaflet and the connecting skirt with the second stitches along the second stitch line.

9. The prosthetic heart valve of any preceding claim, wherein the first stitch line is axially offset from the second stitch line by 0.5-0.8 mm.

10. A prosthetic heart valve, comprising: a radially expandable and compressible frame having an inflow end and an outflow end, the frame comprising a plurality of struts defining openings between them; a valvular structure comprising a plurality of leaflets, each leaflet comprising a coaptation edge portion and a cusp edge portion, the cusp edge portion of each leaflet being folded toward the outflow end of the frame along a bending axis; a reinforcing member extending along an outflow surface of the cusp edge portion of each leaflet along the bending axis; and a connecting skirt disposed between the cusp edge portions of the leaflets and the frame; wherein the connecting skirt is connected to the frame with first stitches to adjacent struts to form a first stitch line; andAttorney Docket No: THVVA-13343WO01 wherein the cusp edge portions of the leaflets are stitched to the connecting skirt with second stitches along a second stitch line that is axially offset from the first stitch line toward the inflow end of the frame.

11. The prosthetic heart valve of claim 10, wherein the second stitch line is offset from the first stitch line by a distance that is constant around a circumference of the frame.

12. The prosthetic heart valve of any of claims 10-11, wherein the connecting skirt is folded to form an inner layer, an outer layer, and a fold, and wherein the fold is oriented toward the outflow end of the frame such that both inner and outer layers extend from the fold toward the inflow end of the frame.

13. The prosthetic heart valve of claim 12, wherein each of the first stitches and the second stitches extend through the inner and outer layers of the connecting skirt.

14. The prosthetic heart valve of any of claims 10-13, wherein the reinforcing member is axially offset from the first stitch line toward the inflow end of the frame.

15. The prosthetic heart valve of claim 14, wherein the reinforcing member is axially offset from the first stitch line by 0.5-0.8 mm.

16. The prosthetic heart valve of any of claims 10-15, wherein the reinforcing member is stitched to the cusp edge portion of each leaflet and the connecting skirt with the second stitches along the second stitch line.

17. A method of assembling a prosthetic heart valve comprising a frame and a plurality of leaflets, the method comprising: stitching a connecting skirt to adjacent struts of the frame with a plurality of first stitches to form a first stitch line; andAttorney Docket No: THVVA-13343WO01 stitching the connecting skirt to cusp edge portions of the leaflets with a plurality of second stitches to form a second stitch line, which is parallel to and axially offset from the first stitch line toward an inflow end of the frame.

18. The method of claim 17, wherein the second stitch line is offset from the first stitch line by a distance that is constant around a circumference of the frame.

19. The method of any of claims 17-18, comprising: folding the cusp edge portion of each leaflet toward an outflow end of the frame along a bending axis; and securing a reinforcing member along an outflow surface of the cusp edge portion of each leaflet along the bending axis.

20. The method of claim 19, wherein the reinforcing member is axially offset from the first stitch line by 0.5-0.8 mm.

21. The method of any of claims 19-20, wherein securing the reinforcing member to the cusp edge portion of each leaflet comprises stitching the reinforcing member to the cusp edge portion of each leaflet and the connecting skirt with the second stitches along the second stitch line.

22. The method of any of claims 17-18, comprising securing a reinforcing member along an inflow surface of the cusp edge portion of each leaflet in a position axially offset from the first stitch line toward the inflow end of the frame.

23. The method of claim 22, wherein the reinforcing member is axially offset from the first stitch line by 0.5-0.8 mm.Attorney Docket No: THVVA-13343WO01 24. The method of any of claims 22-23, wherein securing the reinforcing member to the cusp edge portion of each leaflet comprises stitching the reinforcing member to the cusp edge portion of each leaflet and the connecting skirt with the second stitches along the second stitch line.

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