Prosthetic heart valve

Abstract

Prosthetic heart valves and leaflets are disclosed. In some examples, a prosthetic heart valve comprises a frame that is radially expandable and collapsible; and a plurality of leaflets mounted on an inside of the frame, wherein each leaflet comprises a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end, two first tabs disposed on opposite sides of the main body, two second tabs disposed on opposite sides of the main body, and two cutout regions disposed on opposite sides of the main body axially between a respective second tab and the cusp edge portion, wherein the free edge includes a peak that extends away from the cusp edge portion, wherein the first tabs are folded against the second tabs, and wherein first and second tabs of adjacent leaflets are paired to form a commissure.

Description

PROSTHETIC HEART VALVECROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No.63 / 762,417, filed February 24, 2025, which is incorporated by reference herein.FIELD

[0002] The present disclosure relates to prosthetic heart valves, and in particular to leaflet configurations for prosthetic heart valves.BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable.

[0004] In a specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.

[0005] An anchoring or docking device can be used in conjunction with an expandable prosthetic implant, for example a prosthetic valve, at an implantation site such as a native heart valve. The anchoring device can be used to securely hold the prosthetic implant in place at the implantation site when the prosthetic implant is expanded. Docking devices can, for example, provide a stable anchoring site, landing zone, or implantation zone at the implant site in which prosthetic implants can be expanded or otherwise secured. Docking devices can be delivered to the implantation site by a delivery apparatus.SUMMARY

[0006] Described herein are prosthetic heart valves, delivery apparatus, and methods for implanting prosthetic heart valves. The disclosed prosthetic heart valves, delivery apparatus, and methods can, for example, provide leaflet configurations that facilitate a more naturally open leaflet to improve hydrodynamics (e.g., increase effective orifice area (EOA), reduce gradients, etc.) as well as improve flow through the valve, including improving leaflet mobility under low flow mitral conditions. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatus.

[0007] The disclosed prosthetic heart valves and / or leaflet configurations can be particularly advantageous, for example, when used with a docking device and / or an implantation location that results in the prosthetic valve having an hourglass deployment shape.

[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.

[0009] In some examples, a prosthetic heart valve can comprise a plurality of leaflets configured to regulate a flow of blood through the prosthetic heart valve.

[0010] In some examples, a prosthetic heart valve can be adapted for use in a docking device and comprise a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration, wherein the frame comprises an hourglass shape in the radially expanded configuration.

[0011] In some examples, a prosthetic heart valve a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration; and a plurality of leaflets mounted on an inside of the frame, wherein each leaflet comprises a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end, two first tabs disposed on opposite sides of the main body, two second tabs disposed on opposite sides of the main body, and two cutout regions disposed on opposite sides of the main body axially between a respective second tab and the cusp edge portion, wherein the free edge includes a peak that extends away from the cusp edge portion, wherein the first tabs are folded against the second tabs, and wherein first and second tabs of adjacent leaflets are paired to form a commissure that is secured to the frame.

[0012] In some examples, a prosthetic heart valve comprises one or more of the components recited in Examples 1-5 and 18-21 below.

[0013] In some examples, a leaflet comprises a main body having a free edge and a cusp edge portion.

[0014] In some examples, a leaflet comprises commissure tabs disposed on opposite sides of the main body and cutout regions disposed on opposite sides of the main body, wherein the cutout regions are disposed axially between the commissure tabs and the cusp edge portion.

[0015] In some examples, a leaflet comprises a main body with a free, outflow edge, a cusp edge portion, and cutout regions disposed on opposite sides of the main body, wherein the outflow edge includes a peak that extends away from the cusp edge portion, wherein the cusp edge portion terminates at upper ends thereof at the cutout regions, and wherein side edges of the main body at least partially define the cutout regions; two first tabs disposed on opposite sides of the main body, wherein the first tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet; two second tabs disposed on opposite sides of the main body and extending laterally outward from the main body; and two offsetting portions, each offsetting portion extending between a respective first tab and second tab and offsetting the respective first tab axially and laterally away from the outflow edge of the main body, wherein each first tab has opposing inner and outer edges that are parallel to one another and disposed parallel to the central longitudinal axis of the leaflet.

[0016] In some examples, a leaflet comprises a main body with a free edge and a cusp edge portion, the free edge disposed at an outflow end of the leaflet; two first tabs disposed on opposite sides of the main body, wherein the first tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet, wherein each first tab has an outer edge and an inner edge disposed opposite the outer edge, wherein the inner and outer edges of each first tab are parallel to the central longitudinal axis of the leaflet; two second tabs disposed on opposite sides of the main body and extending laterally outward from the main body, wherein the second tabs are disposed closer to the cusp edge portion than the first tabs; two cutout regions disposed on opposite sides of the main body, wherein side edges of the main body at least partially define the cutout regions, wherein the side edges extend in the axial direction between second tabs and upper ends of the cusp edge portion; and two offsetting portions, each offsetting portion extending between a respective first tab and second tab and offsetting the respective first tab axially and laterally away from the free edge of the main body, wherein each offsetting portion comprises an outer edge that extends between an inflow edge of the respective first tab and an outflow edge of the respective second tab.

[0017] In some examples, a leaflet comprises one or more of the components recited in Examples 6-17 and 22-23 below.

[0018] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0019] FIG. 1A schematically illustrates a first stage in an exemplary mitral valve replacement procedure where a guide catheter and a guidewire are inserted into a blood vessel of a patient and navigated through the blood vessel and into a heart of the patient, towards a native mitral valve of the heart.

[0020] FIG. 1B schematically illustrates a second stage in the exemplary mitral valve replacement procedure where a docking device delivery apparatus extending through the guide catheter is implanting a docking device for a prosthetic heart valve at the native mitral valve.

[0021] FIG. 1C schematically illustrates a third stage in the exemplary mitral valve replacement procedure where the docking device of FIG. 1B is fully implanted at the native mitral valve of the patient and the docking device delivery apparatus has been removed from the patient.

[0022] FIG. ID schematically illustrates a fourth stage in the exemplary mitral valve replacement procedure where a prosthetic heart valve delivery apparatus extending through the guide catheter is implanting a prosthetic heart valve in the implanted docking device at the native mitral valve.

[0023] FIG. IE schematically illustrates a fifth stage in the exemplary mitral valve replacement procedure where the prosthetic heart valve is fully implanted within the docking device at the native mitral valve and the prosthetic heart valve delivery apparatus has been removed from the patient.

[0024] FIG. IF schematically illustrates a sixth stage in the exemplary mitral valve replacement procedure where the guide catheter and the guidewire have been removed from the patient.

[0025] FIG. 2 is a perspective view of a prosthetic heart valve, according to an example.

[0026] FIG. 3 is a plan view of a portion of the frame of the prosthetic heart valve of FIG. 2 in a laid flat configuration.

[0027] FIG. 4 is a plan view of a leaflet of the prosthetic heart valve of FIG. 2.

[0028] FIG. 5 is a plan view of a reinforcing strip of the prosthetic heart valve of FIG. 2.

[0029] FIG. 6 is a plan view of an inner skirt of the prosthetic heart valve of FIG. 2.DETAILED DESCRIPTIONGeneral Considerations

[0030] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems 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.

[0031] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0032] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0033] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0034] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Examples of the Disclosed Technology

[0035] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0036] FIGS. 1A-1F depict one example of a transcatheter heart valve replacement procedure (e.g., a mitral valve replacement procedure) which utilizes a docking device 52 and a prosthetic heart valve 62. As described above, the docking device 52 can be used to securely hold the prosthetic heart valve 62 in place at the native mitral valve, where the prosthetic heart valve 62 can be radially expanded inside the docking device 52 within the annulus of the native mitral valve. Although FIG. 1A-1F show the procedure using the docking device 52 and the prosthetic heart valve 62, it is understood that any docking device or prosthetic heart valve described herein can be used.

[0037] During the example procedure depicted in FIGS. 1A-1F, a user first creates a pathway to a patient’s native heart valve using a guide catheter 30 (FIG. 1A). The user then delivers and implants the docking device 52 at the patient’s native heart valve using a docking device delivery apparatus 50 (FIG. 1B) and then removes the docking device delivery apparatus 50 from the patient 10 after implanting the docking device 52 (FIG. 1C). The user then implants the prosthetic heart valve 62 within the implanted docking device 52 using a prosthetic valve delivery apparatus 60 (FIG. 1D). Thereafter, the user removes theprosthetic valve delivery apparatus 60 from the patient 10 (FIG. 1E), as well as the guide catheter 30 (FIG. 1F).

[0038] FIG. 1A depicts a first stage in a mitral valve replacement procedure, according to an example, where the guide catheter 30 and a guidewire 40 are inserted into a blood vessel 12 of a patient 10 and navigated through the blood vessel 12, into a heart 14 of the patient 10, and toward the native mitral valve 16. Together, the guide catheter 30 and the guidewire 40 can provide a path for the docking device delivery apparatus 50 and the prosthetic valve delivery apparatus 60 to be navigated through and along, to the implantation site (the native mitral valve 16 or native mitral valve annulus).

[0039] Initially, the user may first make an incision in the patient’s body to access the blood vessel 12. For example, in the example illustrated in FIG. 1A, the user may make an incision in the patient’s groin to access a femoral vein. Thus, in such examples, the blood vessel 12 may be a femoral vein.

[0040] After making the incision at the blood vessel 12, the user may insert the guide catheter 30, the guidewire 40, and / or additional devices (such as an introducer device or transseptal puncture device) through the incision and into the blood vessel 12. The guide catheter 30 (which can also be referred to as an “introducer device,” “introducer,” or “guide sheath”) is configured to facilitate the percutaneous introduction of various implant delivery devices (e.g., the docking device delivery apparatus 50 and the prosthetic valve delivery apparatus 60) into and through the blood vessel 12 and may extend through the blood vessel 12 and into the heart 14 but may stop short of the native mitral valve 16. The guide catheter 30 can comprise a handle 32 and a shaft 34 extending distally from the handle 32. The shaft 34 can extend through the blood vessel 12 and into the heart 14 while the handle 32 remains outside the body of the patient 10 and can be operated by the user in order to manipulate the shaft 34.

[0041] The guidewire 40 is configured to guide the delivery apparatuses (e.g., the guide catheter 30, the docking device delivery apparatus 50, the prosthetic valve delivery apparatus 60, additional catheters, or the like) and their associated devices (e.g., docking device, prosthetic heart valve, and the like) to the implantation site within the heart 14, and thus may extend all the way through the blood vessel 12 and into a left atrium 18 of the heart 14 (and in some examples, through the native mitral valve 16 and into a left ventricle of the heart 14) as shown in FIG. 1A.

[0042] In some examples, a transseptal puncture device or catheter can be used to initially access the left atrium 18, prior to inserting the guidewire 40 and the guide catheter 30. For example, after making the incision to the blood vessel 12, the user may insert a transseptalpuncture device through the incision and into the blood vessel 12. The user may guide the transseptal puncture device through the blood vessel 12 and into the heart 14 (e.g., through the femoral vein and into the right atrium 20). The user can then make a small incision in an atrial septum 22 of the heart 14 to allow access to the left atrium 18 from the right atrium 20. The user can then insert and advance the guidewire 40 through the transseptal puncture device within the blood vessel 12 and through the incision in the atrial septum 22 into the left atrium 18. Once the guidewire 40 is positioned within the left atrium 18 and / or the left ventricle 26, the transseptal puncture device can be removed from the patient 10. The user can then insert the guide catheter 30 into the blood vessel 12 and advance the guide catheter 30 into the left atrium 18 over the guidewire 40 (FIG. 1A).

[0043] In some examples, an introducer device can be inserted through a lumen of the guide catheter 30 prior to inserting the guide catheter 30 into the blood vessel 12. In some instances, the introducer device can include a tapered end that extends out a distal tip of the guide catheter 30 and that is configured to guide the guide catheter 30 into the left atrium 18 over the guidewire 40. Additionally, in some instances, the introducer device can include a proximal end portion that extends out a proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user can remove the introducer device from inside the guide catheter 30 and the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain inside the patient 10. The guide catheter 30 is then in position to receive an implant delivery apparatus and help guide it to the left atrium 18, as described further below.

[0044] FIG. 1B depicts a second stage in the exemplary mitral valve replacement procedure where the docking device 52 is being implanted at the native mitral valve 16 of the heart 14 of the patient 10 using the docking device delivery apparatus 50 (which may also be referred to as an “implant catheter,” a “delivery apparatus,” and / or a “docking device delivery device”).

[0045] In general, the docking device delivery apparatus 50 comprises a delivery shaft 54, a handle 56, and a pusher assembly 58. The delivery shaft 54 is configured to be advanced through the patient’s vasculature (blood vessel 12) and to the implantation site (e.g., native mitral valve 16) by the user and may be configured to retain the docking device 52 at a distal end portion 53 of the delivery shaft 54. In some examples, the distal end portion 53 of the delivery shaft 54 retains the docking device 52 therein in a straightened deliveryconfiguration.

[0046] The handle 56 of the docking device delivery apparatus 50 is configured to be gripped and / or otherwise held by the user, outside the body of the patient 10, to advance the delivery shaft 54 through the patient’s vasculature (e.g., blood vessel 12).

[0047] In some examples, the handle 56 can comprise one or more articulation members 57 (or rotatable knobs) that are configured to aid in positioning the delivery shaft 54 within the heart 14. For example, the one or more articulation members 57 can comprise one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members that are configured to be adjusted by the user to flex, bend, twist, turn, and / or otherwise articulate the distal end portion 53 of the delivery shaft 54 to aid in positioning the delivery shaft 54 within the heart 14 for deployment of the docking device 52 at the implantation site (e.g., the native mitral valve 16).

[0048] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at the implantation site (e.g., the native mitral valve 16). For example, the pusher assembly 58 can be configured to be adjusted by the user to push the docking device 52 out of the distal end portion 53 of the delivery shaft 54. A pusher shaft of the pusher assembly 58 can extend through the delivery shaft 54 and can be disposed adjacent to the docking device 52 within the delivery shaft 54. In some examples, the docking device 52 can be releasably coupled to the pusher shaft of the pusher assembly 58 via a connection mechanism of the docking device delivery apparatus 50 such that the docking device 52 can be released after being deployed at the native mitral valve 16. An example of a connection mechanism will be described in more detail below in connection with FIGS. 5-10. Further details of the docking device delivery apparatus and its variants are described in PCT No. W02020 / 247907, which is incorporated by reference herein in its entirety.

[0049] Referring again to FIG. 1B, after the guide catheter 30 is positioned within the left atrium 18, the user may insert the docking device delivery apparatus 50 (e.g., the delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 of the docking device delivery apparatus 50 through the guide catheter 30 and over the guidewire 40. In some examples, the guidewire 40 can be at least partially retracted away from the left atrium 18 and into the guide catheter 30. In other examples, the guidewire 40 can be fully removed from the guide catheter 30 prior to insertion of the docking device delivery apparatus 50. The user may then continue to advance the delivery shaft 54 of the docking device delivery apparatus 50 through the blood vessel 12 within the guide catheter 30 until the delivery shaft 54 reaches the left atrium 18, as illustrated in FIG. IB. Specifically, the user may advance the delivery shaft 54 of the docking device delivery apparatus 50 by gripping and exerting a force on (e.g.,pushing) the handle 56 of the docking device delivery apparatus 50 toward the patient 10. While advancing the delivery shaft 54 through the blood vessel 12 and the heart 14, the user may adjust the one or more articulation members 57 of the handle 56 to navigate the various turns, corners, constrictions, and / or other obstacles in the blood vessel 12 and the heart 14.

[0050] Once the delivery shaft 54 reaches the left atrium 18 and extends out of a distal end of the guide catheter 30, the user can position the distal end portion 53 of the delivery shaft 54 at and / or near the posteromedial commissure of the native mitral valve 16 using the handle 56 (e.g., the articulation members 57). The user may then push the docking device 52 out of the distal end portion 53 of the delivery shaft 54 with the shaft of the pusher assembly 58 to deploy and / or implant the docking device 52 within the annulus of the native mitral valve 16.

[0051] In some examples, the docking device 52 may be constructed from, formed of, and / or comprise a shape memory material, and as such, may return to its original, pre-formed shape when it exits the delivery shaft 54 and is no longer constrained by the delivery shaft 54. As one example, the docking device 52 may originally be formed as a coil, and thus may wrap around leaflets 24 of the native mitral valve 16 as it exits the delivery shaft 54 and returns to its original coiled configuration.

[0052] After pushing a ventricular portion of the docking device 52 (e.g., the portion of the docking device 52 shown in FIG. IB that is configured to be positioned within a left ventricle 26 and / or on the ventricular side of the native mitral valve 16), the user may then deploy the remaining portion of the docking device 52 (e.g., an atrial portion of the docking device 52) from the delivery shaft 54 within the left atrium 18 by retracting the delivery shaft 54 away from the posteromedial commissure of the native mitral valve 16.

[0053] After deploying and implanting the docking device 52 at the native mitral valve 16, the user may disconnect the docking device delivery apparatus 50 from the docking device 52. Once the docking device 52 is disconnected from the docking device delivery apparatus 50, the user may retract the docking device delivery apparatus 50 out of the blood vessel 12 and away from the patient 10 so that the user can deliver and implant a prosthetic heart valve 62 within the implanted docking device 52 at the native mitral valve 16.

[0054] FIG. 1C depicts a third stage in the mitral valve replacement procedure, where the docking device 52 has been fully deployed and implanted at the native mitral valve 16 and the docking device delivery apparatus 50 (including the delivery shaft 54) has been removed from the patient 10, such that only the guide catheter 30 remains inside the patient 10. In some examples, both the guide catheter 30 and the guidewire 40 remain inside the patient 10. After removing the docking device delivery apparatus 50, the guidewire 40 can be advancedthrough and / or out of the guide catheter 30, through the implanted docking device 52 at the native mitral valve 16, and into the left ventricle 26 (FIG. 1B). As such, the guidewire 40 can help to guide the prosthetic valve delivery apparatus 60 through the annulus of the native mitral valve 16 and at least partially into the left ventricle 26.

[0055] As illustrated in FIG. 1C, the docking device 52 can comprise a plurality of turns (or coils) that wrap around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The implanted docking device 52 has a more cylindrical shape than the annulus of the native mitral valve 16, thereby providing a geometry that more closely matches the shape or profile of the prosthetic heart valve to be implanted. As a result, the docking device 52 can provide a tighter fit, and thus a better seal, between the prosthetic heart valve and the native mitral valve 16.

[0056] FIG. ID depicts a fourth stage in the mitral valve replacement procedure where the user is delivering and / or implanting a prosthetic heart valve 62 (which can also be referred to herein as a “transcatheter heart valve” or “THV” for short, “replacement heart valve,” and / or “prosthetic mitral valve”) within the docking device 52 using a prosthetic valve delivery apparatus 60.

[0057] As shown in FIG. ID, the prosthetic valve delivery apparatus 60 can comprise a delivery shaft 64 and a handle 66, the delivery shaft 64 extending distally from the handle 66. The delivery shaft 64 is configured to extend into the patient’ s vasculature to deliver, implant, expand, and / or otherwise deploy the prosthetic heart valve 62 within the docking device 52 at the native mitral valve 16. The handle 66 is configured to be gripped and / or otherwise held by the user to advance the delivery shaft 64 through the patient’s vasculature.

[0058] In some examples, the handle 66 can comprise one or more articulation members 68 that are configured to aid in navigating the delivery shaft 64 through the blood vessel 12 and the heart 14. Specifically, the articulation member(s) 68 can comprise one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members that are configured to be adjusted by the user to flex, bend, twist, turn, and / or otherwise articulate a distal end portion of the delivery shaft 64 to aid in navigating the delivery shaft 64 through the blood vessel 12 and into the left atrium 18 and left ventricle 26 of the heart 14.

[0059] In some examples, the prosthetic valve delivery apparatus 60 can include an expansion mechanism 65 that is configured to radially expand and deploy the prosthetic heart valve 62 at the implantation site. In some instances, as shown in FIG. ID, the expansion mechanism 65 can comprise an inflatable balloon that is configured to be inflated to radiallyexpand the prosthetic heart valve 62 within the docking device 52. The inflatable balloon can be coupled to the distal end portion of the delivery shaft 64.

[0060] In other examples, the prosthetic heart valve 62 can be self-expanding and can be configured to radially expand on its own upon removable of a sheath or capsule covering the radially compressed prosthetic heart valve 62 on the distal end portion of the delivery shaft 64. In still other examples, the prosthetic heart valve 62 can be mechanically expandable and the prosthetic valve delivery apparatus 60 can include one or more mechanical actuators (e.g., the expansion mechanism) configured to radially expand the prosthetic heart valve 62.

[0061] As shown in FIG. ID, the prosthetic heart valve 62 can be mounted around the expansion mechanism 65 (the inflatable balloon) on the distal end portion of the delivery shaft 64, in a radially compressed configuration.

[0062] To navigate the distal end portion of the delivery shaft 64 to the implantation site, the user can insert the prosthetic valve delivery apparatus 60 (the delivery shaft 64) into the patient 10 through the guide catheter 30 and over the guidewire 40. The user can continue to advance the prosthetic valve delivery apparatus 60 along the guidewire 40 (through the blood vessel 12) until the distal end portion of the delivery shaft 64 reaches the native mitral valve 16, as illustrated in FIG. ID. More specifically, the user can advance the delivery shaft 64 of the prosthetic valve delivery apparatus 60 by gripping and exerting a force on (e.g., pushing) the handle 66. While advancing the delivery shaft 64 through the blood vessel 12 and the heart 14, the user can adjust the one or more articulation members 68 of the handle 66 to navigate the various turns, comers, constrictions, and / or other obstacles in the blood vessel 12 and heart 14.

[0063] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 62 mounted around the distal end portion of the delivery shaft 64 is positioned within the docking device 52 and the native mitral valve 16. In some examples, as shown in FIG. ID, a distal end of the delivery shaft 64 and a least a portion of the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26.

[0064] Once the radially compressed prosthetic heart valve 62 is appropriately positioned within the docking device 52 (FIG. ID), the user can manipulate one or more actuation mechanisms of the handle 66 of the prosthetic valve delivery apparatus 60 to actuate the expansion mechanism 65 (e.g., inflate the inflatable balloon), thereby radially expanding the prosthetic heart valve 62 within the docking device 52.

[0065] FIG. IE shows a fifth stage in the mitral valve replacement procedure where the prosthetic heart valve 62 is in its radially expanded configuration and implanted within the docking device 52 in the native mitral valve 16. As shown in FIG. IE, the prosthetic heart valve 62 is received and retained within the docking device 52. Thus, the docking device 52 aids in anchoring the prosthetic heart valve 62 within the native mitral valve 16. In some examples, the docking device 52 can enable better sealing between the prosthetic heart valve 62 and the leaflets 24 of the native mitral valve 16 to reduce paravalvular leakage around the prosthetic heart valve 62.

[0066] As also shown in FIG. IE, after the prosthetic heart valve 62 has been fully deployed and implanted within the docking device 52 at the native mitral valve 16, the prosthetic valve delivery apparatus 60 (including the delivery shaft 64) can be removed from the patient 10 such that only the guidewire 40 and the guide catheter 30 remain inside the patient 10.

[0067] FIG. IF depicts a sixth stage in the mitral valve replacement procedure, where the guidewire 40 and the guide catheter 30 have been removed from the patient 10.

[0068] Although FIGS. 1 A-1F specifically depict a mitral valve replacement procedure, it should be appreciated that a similar procedure may be utilized to replace other heart valves (e.g., tricuspid, pulmonary, and / or aortic valves). Further, the same and / or similar delivery apparatuses (e.g., docking device delivery apparatus 50, prosthetic valve delivery apparatus 60, guide catheter 30, and / or guidewire 40), docking devices (e.g., docking device 52, or any other docking device described herein), replacement heart valves (e.g., prosthetic heart valve 62, or any other prosthetic valve described herein), and / or components thereof may be utilized for replacing these other heart valves. Additional details regarding implantation procedures for docking devices and prosthetic heart valves are described in PCT Publication No. W02023 / 205076, which is incorporated by reference herein.

[0069] 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.

[0070] FIG. 2 shows an exemplary prosthetic implant in the form of a prosthetic mitral valve 100, according to another example. The prosthetic valve 100 can be implanted within the docking device 52 in lieu of the prosthetic valve 62, as described above in connection with FIGS. 1D-1F.

[0071] In some examples, the disclosed prosthetic valves (for example, prosthetic valves 62 and 100) can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U. S. Publication No. 2017 / 0231756, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020 / 247907. 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. In some examples, the disclosed prosthetic valves can be implanted within native anatomy without the use of a docking device.

[0072] Referring again to FIG. 2, the prosthetic valve 100 can comprise a frame 102, a valvular structure 104 comprising a plurality of leaflets 200 situated at least partially within the frame 102, and an outer sealing member 106 (which is also referred to herein as an “outer skirt’') situated about the frame 102. As described in more detail below, the prosthetic valve 100 can also include an inner skirt 116 (FIG. 6) disposed within the frame 102. As shown in FIG. 2, the prosthetic valve 100 includes an inflow end 108 and an outflow end 110. The terms “inflow” and “outflow” are related to the normal direction of blood flow (for example, antegrade blood flow) through the prosthetic valve 100. For example, the leaflets 200 can allow blood flow through the valve 100 in a direction from the inflow end 108 to the outflow end 110 and prevent the reverse flow (for example, prevent flow in a direction from the outflow end 110 to the inflow end 108).

[0073] The valvular structure 104 can comprise a plurality of leaflets 200 collectively forming a leaflet structure. In some examples, the valvular structure 104 can comprise three leaflets 200 arranged in a tricuspid arrangement. However, there can be a greater or fewer number of leaflets 200. The leaflets 200 can be secured to one another at their adjacent sides to form commissures of the valvular structure 104. The lower edge of the valvular structure 104 can have an undulating, curved scalloped shape. In some examples, the leaflets 200 can be formed of pericardial tissue (such as bovine pericardial tissue), biocompatible syntheticmaterials, or other various 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.

[0074] The frame 102 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol). When constructed of a plastically-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable catheter balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size, as introduced above.

[0075] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 102) include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 102 can comprise stainless steel. In some examples, the frame 102 can comprise cobalt-chromium. In some examples, the frame 102 can comprise nickel -cobaltchromium. In some examples, the frame 102 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0076] The outer skirt 106 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the skirt 106 can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plush nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the skirt 106 can comprise a fabric without interlaced yarns or fibers or randomly interlaced yams or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the skirt 106 can comprise a non-textile or non-fabric material, such as a film made from any of a variety ofpolymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the skirt 106 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the skirt 106 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0077] Further details of the prosthetic heart valve and its variants are described in U. S. Patent No. 11,185,406, which is incorporated by reference herein in its entirety.

[0078] FIGS. 3-4 illustrate the frame 102 and the leaflet 200 of the prosthetic heart valve 100 alone, respectively. While the prosthetic heart valve 100 is oriented in FIG. 2 with the inflow end 108 positioned upwards and the outflow end 110 positioned downwards, FIGS. 3-4 invert this orientation for purposes of illustration, such that the inflow end 108 is positioned downwards and the outflow end 110 is positioned upwards.

[0079] FIG. 3 illustrates the frame 102 in a laid-flat configuration for purposes of illustration. The frame 102 includes a plurality of strut members 112 that can be arranged end-to-end to form a plurality of rows or rungs of strut members that extend circumferentially around the frame 102. For example, with reference to FIG. 3, the frame 102 can comprise a first or lower row I of angled strut members 112 forming the inflow end 108 of the frame; a second row II of strut members 112 above the first row; a third row III of strut members 112 above the second row; a fourth row IV of strut members 112 above the third row, and a fifth row V of strut members 112 above the fourth row and forming the outflow end 110 of the frame. At the outflow end 110 of the frame, the strut members 112 of the fifth row V can be arranged at alternating angles in a zig-zag pattern. The stmt members 112 of the fifth row V are spaced apart from the stmt members 112 of the fourth row IV by axial stmts 136 and commissure windows 138. The stmt members 112 of the fifth row V can be joined together at their distal ends (relative to the direction of implantation in the mitral valve) to form the apices 114 and joined together at their proximal ends at junctions 134, which may form part of the commissure windows 138 and the axial stmts 136. Additional structure and characteristics of the rows I-V of stmt members 112 are described in greater detail in U. S. Patent No.9,393,110, which is incorporated by reference herein in its entirety.

[0080] The prosthetic valve 100 can be advantageous for use in a docking device, such as docking device 52. In some instances, the prosthetic heart valve 100 assumes an hourglass configuration when expanded within the docking device 52. For example, the prosthetic heart valve 100 may include a narrowed valve waist between the inflow end 108 and outflow end 110 of the prosthetic heart valve 100 due to the constraint of the docking device 52. Inother words, a narrowed valve waist can occur at the location where the prosthetic heart valve 100 contacts the docking device 52 (e.g., at the functional turns of the docking device) when implanted within the docking device 52. In some instances, the prosthetic heart valve 100 assumes an hourglass configuration when expanded at certain implantation locations without the use of a docking device. For example, the native anatomy may contact the expanded prosthetic heart valve in such a way that results in an hourglass deployment shape. The geometry of the leaflets 200 is designed to fit the hourglass deployment shape of the prosthetic heart valve 100 in a manner that facilitates a more naturally open leaflet to improve hydrodynamics (e.g., increase EOA, reduce gradients, etc.) as well as improve flow through the valve 100, including improving leaflet mobility under relatively low flow mitral conditions.

[0081] The leaflet 200 of the prosthetic heart valve 100 of FIG. 2 is shown in a flattened configuration in FIG. 4. The leaflet 200 has a main body 202 with a free edge 204 (which can also be referred to as an outflow edge) and a cusp edge portion 206 (also referred to as an inflow edge portion) that is in opposing relation to the free edge 204. The free edge 204 is configured to move and contact respective free edges of the other leaflets of a leaflet assembly during closure of the leaflets (e.g., during atrial diastole). As described further below, the cusp edge portion 206 is configured to be attached to an inner skirt, which in turn can be attached to a frame of a prosthetic heart valve. In some examples, the cusp edge portion 206 can be directly attached to struts of the frame of the prosthetic heart valve.

[0082] In some examples, as shown in FIG. 4, the free edge 204 comprises angled straight or linear edges that form a peak 207 at a center or midpoint of the free edge 204. In this way, the free edge 204 is angled relative to a central longitudinal axis 212 of the leaflet 200 (e.g., at angles of less than 90 degrees). In some examples, the additional leaflet material provided by the peak 207 can improve coaptation of the leaflet 200. In some examples, the free edge 204 can comprise a straight or linear edge that is perpendicular to the central longitudinal axis 212.

[0083] In some examples, as shown in FIG. 4, the cusp edge portion 206 comprises a U-shape. In some examples, the cusp edge portion 206 comprises a curved or scalloped shape. In some examples, the radius of curvature of the cusp edge portion 206 is or is at least substantially constant.

[0084] In some examples, a U-shaped cusp edge portion 206 has a relatively high degree of circularity that can result in a taller leaflet 200. For example, an axial height 258 of the body 202 of the leaflet 200 between the peak 207 and the cusp edge portion 206 taken in adirection parallel to the longitudinal axis 212 can be greater when the cusp edge portion 206 comprises a U-shape. In some examples, the axial height 258 of the body 202 of the leaflet 200 is 16-24 mm, 18-22 mm, or 19-21 mm. In some examples, the geometry of the free edge 204 including the peak 207 and the cusp edge portion 206 being U-shaped can make the leaflet 200 more robust against central leak at larger deployment sizes (e.g., close to or greater than the nominal diameter) and reduce the likelihood of leaflet mismatch when the leaflets 200 are assembled together.

[0085] In some examples, the leaflet 200 further comprises two sets of opposing commissure tabs disposed on opposite sides of the leaflet 200. For example, the leaflet 200 includes a pair of first tabs 208 disposed on opposite sides of the leaflet 200 and a pair of second tabs 210 disposed on opposite sides of the leaflet 200. The second tabs 210 are disposed closer to the cusp edge portion 206 than the first tabs 208 in the flattened configuration shown in FIG.4.

[0086] The second tabs 210 extend laterally outward from the body 202 of the leaflet 200, relative to the central longitudinal axis 212 of the leaflet 200. The longitudinal axis 212 may be an axis about which leaflet 200 is symmetrical. As used herein, the axial direction can be a direction parallel to the central longitudinal axis 212 and the lateral direction can be perpendicular to the central longitudinal axis 212 (e.g., from one side of the leaflet to the opposite side of the leaflet, across the central longitudinal axis 212). As shown in FIG. 4, the central longitudinal axis 212 of the leaflet 200 extends from the inflow end to the outflow end of the leaflet 200.

[0087] An outflow edge 214 of each second tab 210 is positioned at an angle relative to the central longitudinal axis 212. In some examples, the angle is 88-92 degrees or 90 degrees as depicted in FIG. 4. A lower or inflow edge 224 of each second tab 210 is positioned at an angle relative to the central longitudinal axis 212. In some examples, the angle is 88-92 degrees or 90 degrees as depicted in FIG. 4. In some examples, as shown in FIG. 4, the outflow edge 214 of each second tab 210 is axially offset from the free edge 204. In some examples, the outflow edge 214 of each second tab 210 is axially aligned and colinear with the free edge 204.

[0088] Each second tab 210 can have an outer side edge 220. In some examples, as shown in FIG. 4, the outer edge 220 of each second tab 210 is parallel to the central longitudinal axis 212. In some examples, as shown in FIG. 4, the inflow edge 224 and an outflow edge 214 of each second tab 210 are perpendicular to the central longitudinal axis 212.

[0089] Each first tab 208 can have a substantially rectangular shape with an inner edge 228, an outer side edge 230 disposed opposite the inner edge 228, an outflow edge 232, and an inflow edge 234 disposed opposite the outflow edge 232. In some examples, the inner edge 228 and outer edge 230 can be referred to as side edges and are parallel to one another and the central longitudinal axis 212 (and thus they can be referred to as being vertical edges). In some examples, the outflow edge 232 and the inflow edge 234 are parallel to one another and disposed perpendicular to the inner edge 228 and outer edge 230.

[0090] In some examples, as shown in FIG. 4, the inner edge 228 and the outer edge 230 of each first tab 208 are parallel to the outer edge 220 of the respective second tab 210.

[0091] In some examples, the second tabs 210 and the first tabs 208 are vertically oriented, as shown in FIG. 4, such that each of the inner edges 228 and the outer edges 230 of the first tabs 208 and the outer edges 220 of the second tabs 210 are parallel to the central longitudinal axis 212. This orientation of the first tabs 208 and the second tabs 210 can bring the leaflet 200 closer to the frame 102 when coupled within the prosthetic heart valve 100.

[0092] In some examples, the outer edge 230 of each first tab 208 extends farther laterally outward, away from the body 202 of the leaflet 200, than the outer edge 220 of the respective second tab 210. In some examples, this makes assembly of the commissures to the frame easier and more accurate, thereby ensuring the valve can open as large as possible during operation of the prosthetic heart valve.

[0093] Each first tab 208 is axially and laterally offset from the free edge 204 of the leaflet 200 by an offsetting portion 236 (which can also be referred to as a neck, neck portion, or connecting portion). The offsetting portion 236 extends between the second tab 210 and the first tab 208 on each side of the leaflet 200. For example, each offsetting portion 236 can include a relatively straight outer edge 242 that extends between the inflow edge 234 of the corresponding first tab 208 and the outflow edge 214 of the corresponding second tab 210.

[0094] Each offsetting portion 236 can also include an inner edge having a relatively straight portion 240 and an angled portion 244 that is angled between the straight portion 240 and the inner edge 228 of the corresponding first tab 208. In some examples, the angled portion 244 of the inner edge is angled at 43-47 degrees, or 45 degrees as depicted in FIG. 4, between the straight portion 240 and the inner edge 228 of the corresponding first tab 208. In some examples, the angled portion 244 is angled between 30 degrees and 60 degrees.

[0095] The offsetting portions 236 have a relatively narrow width 246 which allows a length of the free edge 204 (measured between the two offsetting portions 236) to be maximized, thereby allowing the leaflets to open wider and / or decrease pressure gradients across theprosthetic valve, during operation of the prosthetic valve (as described further below). For example, the width 246 of the offsetting portion 236 is 0.8-1.2 mm. In some examples, the length of the free edge 204 (e.g., a distance between the two offsetting portions 236) is selected to correspond to the deployed hourglass shape of the prosthetic heart valve 100.

[0096] The leaflet 200 includes a wing 248 on either side of the main body 202. Each wing 248 is defined by an upper or outflow edge 250 and the cusp edge portion 206. In this manner, the cusp edge portion 206 terminates at its upper ends at the wings 248. The upper edge 250 of the wing 248 is perpendicular to the central longitudinal axis 212 of the leaflet 200. The curved cusp edge portion 206 and the straight outflow edge 250 form a tip of the wing 248 at their junction. In some examples, the second tab 210 extends laterally outwards farther than the tip of the wing 248.

[0097] The wing 248 is spaced apart from the second tab 210 in the axial direction by a side edge 252 of the main body 202. In some examples, the inflow edge 224 of the second tab 210, the side edge 252 of the main body 202, and the upper edge 250 of the wing 248 collectively form a cutout 256. The cutout 256 enables improved opening of the leaflet 200 in that region during operation of the valve 100. Due to the cutout 256, the side edge 252 of the main body 202 is spaced laterally inwards of the side edge 220 of the second tab 210 and spaced laterally inwards of the tip of the wing 248 (e.g., laterally inwards of the upper end of the cusp edge portion 206). In some examples, the side edge 252 is positioned laterally inwards of the outer edge 242 of the offsetting portion 236.

[0098] In some examples, the outer edge 242 of the offsetting portion 236 is positioned laterally outwards of the side edge 252 of the main body 202. In some examples, the outer edge 242 of the offsetting portion 236 and the side edge 252 of the main body 202 are colinear and aligned in the lateral direction.

[0099] In some examples, the inflow edge 224 of the second tab 210 is wider than the upper edge 250 of the wing 248. In some examples, the upper edge 250 of the wing 248 is equal in width to the width 246 of the offsetting portion 236. In some examples, the inflow edge 234 of the first tab 208 is wider than the outflow edge 214 of the second tab 210. In some examples, the outflow edge 232 of the first tab 208 is wider than the inflow edge 224 of the second tab 210. In some examples, the side edge 252 of the main body 202 is taller than the outer edge 242 of the offsetting portion 236.

[0100] In some examples, a width 260 of the cusp edge portion 206 as measured at its upper ends (e.g., at wings 248) is wider than the axial height 258 of the body 202 of the leaflet 200.In some examples, a ratio of the axial height 258 to the width 260 is 0.66-0.75, 0.68-0.73, or 0.70-0.72.

[0101] A plurality of the leaflets 200 (e.g., three leaflets 200) can be assembled together into a leaflet assembly or valvular structure 104 and then secured to the frame 102 of the prosthetic valve 100 shown in FIG. 2. Though shown secured to frame 102, leaflets 200 can be used with a variety of prosthetic heart valve frames.

[0102] When assembled within a frame, the geometry of the leaflets 200 as described above can facilitate a more naturally open leaflet including for valves that assume an hourglass deployment shape (e.g., when deployed within a docking device, when expanded within anatomy that causes an hourglass shape, etc.), which makes the valvular structure 104 more robust against central leakage, prevents leaflet mismatch between adjacent leaflets, and / or can improve hydrodynamics of the valve. For example, valves including a plurality of leaflets 200 and having a certain nominal diameter (e.g., 29 mm) with valve waists of different sizes (e.g., 24 mm, 25.5 mm, 27 mm, 29 mm) were tested against valves including other leaflets under the same testing conditions. Among other differences, the leaflets 200 include a cutout region adjacent the side edge 252 of the main body 202 whereas the other leaflets did not, the leaflets 200 have a more U-shape cusp edge portion 206 than the other leaflets, and the main body 202 of the leaflets 200 is taller than the other leaflets. The valves including the leaflets 200 had similar or greater valve opening size (as demonstrated by greater EGA) than the valves having the other leaflets and had improved hydrodynamic performance (as demonstrated by reduced pressure gradients across the valve) than the valves having the other leaflets.

[0103] As noted above, the leaflet structure 104 in the illustrated embodiment includes three leaflets 200 (although a greater or fewer number of leaflets can be used).Each leaflet 200 can have a reinforcing strip 216 secured (e.g., sewn) to the inner surface of the cusp edge portion 206. For example, as shown in FIG. 5, the reinforcing strip 216 can include a plurality of apertures 218 through which a suture can pass. The reinforcing strip 216 is curved to correspond to the shape of the cusp edge portion 206 of the leaflet 200. In some examples, the reinforcing strip 216 can include tabs 238 at either end of the reinforcing strip 216. In some examples, as shown in FIG. 5, the reinforcing strip 216 can include slits 254, for example, to enable greater flexibility in the reinforcing strip 216.

[0104] The leaflets 200 can be secured to one another at their adjacent sides toform commissures of the leaflet structure 104. A plurality of flexible connectors or posts canbe used to interconnect pairs of adjacent sides of the leaflets 200 and to mount the leaflets 200 to the commissure windows 138.

[0105] Each commissure window 138 is adapted to receive a pair of second tabs 210 of a pair of adjacent leaflets 200 therethrough. For example, adjacent second tabs 210 of two adjacent leaflets 200 can be coupled together (e.g., via a flexible connector or post), and the first tabs 208 of the two adjacent leaflets 200 can be folded downward at their offsetting portions 236 such that the second tabs 210 are disposed between the pair of first tabs 208. The second tabs 210 can then be inserted through a commissure window 138 in the frame 102 and folded across the radially outward facing surface of the frame 102. Each second tab 210 can be coupled to a respective first tab 208 along a suture line.

[0106] Additional details on the assembly of the leaflets 200 to the frame 102, or a similar prosthetic valve frame, can be found in U.S. Patent No. 9,393,110, as already incorporated by reference above.

[0107] As introduced above, the prosthetic heart valve 100 can include an inner skirt 116 secured to an inside of the frame 102. The inner skirt 116 is shown alone in FIG. 6 in a laid-flat configuration. The inner skirt 116 can assist in securing the leaflets 200 to the frame 102 and assist in forming a sufficient seal between the valve and the native annulus by blocking the flow of blood through the open cells of the frame 102 below the cusp edge portion 206 of the leaflets 200.

[0108] The inner skirt 116 includes side edges 118 that extend between an inflow edge 120 and an outflow edge 122 of the inner skirt. The inflow edge 120 can comprise a straight edge and the side edges 118 can be angled relative to the inflow edge 120. For example, the side edges 118 are angled at approximately 45 degrees between the inflow edge 120 and the outflow edge 122. In some examples, the side edges 118 are angled between 30 degrees and 60 degrees. The angled side edges 118 can be secured together to form the inner skirt 116 and the inner skirt 116 can be coupled to the frame 102, for example, with sutures.

[0109] The outflow edge 122 can be formed with a plurality of projections 124 that define an undulated shape that generally follows the shape of the fourth row of strut members 112 immediately adjacent the lower ends of the axis struts 136 and the commissure windows 138. In this manner, the outflow edge 122 of the skirt 116 can be tightly secured to strut members 112 with a plurality of stitches (e.g., whip stitches). The skirt 116 can also be formed with slits 126 to facilitate attachment of the skirt 116 to the frame 102. As shown, the slits 126 are positioned between the projections 124.

[0110] The skirt 116 includes a plurality of apertures 130 that follow an undulating, scallop-shaped path across the skirt 116 that generally follows the shape of the cusp edge portion 206 of the leaflet 200. The leaflets 200 can be coupled to the inner skirt 116 at the apertures 130 using fasteners such as sutures.

[0111] Additional details on the assembly of the skirt 116 to the frame 102, or a similar prosthetic valve frame, and / or assembly of the leaflet 200 to the skirt 116, or a similar skirt, can be found in U.S. Patent No. 9,393,110, as already incorporated by reference above. Delivery Techniques

[0112] 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) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini -thoracotomy, and then advanced through the ascending aorta toward the native aortic valve,

[0113] 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) isintroduced 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.

[0114] 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.

[0115] 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.

[0116] 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.

[0117] 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.

[0118] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with the body parts, tissue, etc. being simulated), etc.Additional Examples of the Disclosed Technology

[0119] 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.

[0120] Example 1. A prosthetic heart valve comprising: a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration; and a plurality of leaflets mounted on an inside of the frame, wherein each leaflet comprises a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end, two first tabs disposed on opposite sides of the main body, two second tabs disposed on opposite sides of the main body, and two cutout regions disposed on opposite sides of the main body axially between a respective second tab and the cusp edge portion, wherein the free edge includes a peak that extends away from the cusp edge portion, wherein the first tabs are folded against the second tabs, and wherein first and second tabs of adjacent leaflets are paired to form a commissure that is secured to the frame.

[0121] Example 2. The prosthetic heart valve of any example herein, particularly example 1, wherein each leaflet comprises a central longitudinal axis, and wherein each first tab has opposing inner and outer edges that are parallel to one another and disposed parallel to the central longitudinal axis of the leaflet.

[0122] Example 3. The prosthetic heart valve of any example herein, particularly either example 1 or example 2, wherein the cutout regions are partially defined by side edges of the main body, and wherein each side edge is disposed laterally inwards of a side edge of a respective second tab.

[0123] Example 4. The prosthetic heart valve of any example herein, particularly any one of examples 1-3, wherein the cusp edge portion comprises a U-shape.

[0124] Example 5. The prosthetic heart valve of any example herein, particularly any one of examples 1-4, wherein the frame comprises an hourglass shape in the radially expanded configuration when expanded within a docking device.

[0125] Example 6. A leaflet for a prosthetic valve, comprising: a main body with a free, outflow edge, a cusp edge portion, and cutout regions disposed on opposite sides of the main body, wherein the outflow edge includes a peak that extends away from the cusp edge portion, wherein the cusp edge portion terminates at upper ends thereof at the cutout regions, and wherein side edges of the main body at least partially define the cutout regions; two first tabs disposed on opposite sides of the main body, wherein the first tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet; two second tabs disposed on opposite sides of the main body and extending laterally outward from the main body; and two offsetting portions, each offsetting portion extending between a respective first tab and second tab and offsetting the respective first tab axially and laterally away from the outflow edge of the main body, wherein each first tab has opposing inner and outer edges that are parallel to one another and disposed parallel to the central longitudinal axis of the leaflet.

[0126] Example 7. The leaflet of any example herein, particularly example 6, wherein each offsetting portion has an outer edge that extends between an inflow edge of the respective first tab and an outflow edge of the respective second tab and an inner edge that comprises a straight portion and an angled portion.

[0127] Example 8. The leaflet of any example herein, particularly example 7, wherein the outer edge of each offsetting portion is disposed farther outward than the side edges of a respective cutout region in the lateral direction, relative to the central longitudinal axis of the leaflet.

[0128] Example 9. The leaflet of any example herein, particularly any of examples 6-8, wherein the outflow edge comprises linear edges that are angled towards the peak.

[0129] Example 10. The leaflet of any example herein, particularly any of examples 6-9, wherein the cusp edge portion of the main body is U-shaped.

[0130] Example 11. A leaflet for a prosthetic valve, comprising: a main body with a free edge and a cusp edge portion, the free edge disposed at an outflow end of the leaflet; two first tabs disposed on opposite sides of the main body, wherein the first tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet, wherein each first tab has an outer edge and an inner edge disposed opposite the outer edge, wherein the inner and outer edges of each first tab are parallel to the central longitudinal axis of the leaflet; two second tabs disposed on opposite sides of the main body and extending laterally outward from the main body, wherein the second tabs are disposed closer to the cusp edge portion than the first tabs; two cutout regions disposed on opposite sides of the main body,wherein side edges of the main body at least partially define the cutout regions, wherein the side edges extend in the axial direction between second tabs and upper ends of the cusp edge portion; and two offsetting portions, each offsetting portion extending between a respective first tab and second tab and offsetting the respective first tab axially and laterally away from the free edge of the main body, wherein each offsetting portion comprises an outer edge that extends between an inflow edge of the respective first tab and an outflow edge of the respective second tab.

[0131] Example 12. The leaflet of any example herein, particularly example 11, wherein the side edges of the main body are parallel to the central longitudinal axis of the leaflet.

[0132] Example 13. The leaflet of any example herein, particularly either example 11 or example 12, wherein the cutout regions are disposed closer to the cusp edge portion that the second tabs in the axial direction.

[0133] Example 14. The leaflet of any example herein, particularly any one of examples 11- 13, wherein the free edge comprises angled portions that form a peak.

[0134] Example 15. The leaflet of any example herein, particularly any one of examples 11- 14, wherein the cusp edge portion comprises a curved shape.

[0135] Example 16. The leaflet of any example herein, particularly any one of examples 11- 15, wherein each side edge of the main body is disposed laterally inwards of an outer edge of a respective second tab.

[0136] Example 17. The leaflet of any example herein, particularly example 16, wherein each side edge of the main body is disposed laterally inwards of the outer edge of each offsetting portion.

[0137] Example 18. A prosthetic heart valve comprising a plurality of the leaflets of any example herein, particularly any one of examples 6-17, wherein for each leaflet, the first tabs are folded over the respective second tabs.

[0138] Example 19. The prosthetic heart valve of any example herein, particularly example 18, wherein the cusp edge portion of each leaflet coupled to struts of a frame of the prosthetic heart valve via an inner skirt of the prosthetic heart valve, and wherein the free edge of the main body of each leaflet is free to move during operation of the prosthetic heart valve to regulate a flow of blood through the prosthetic heart valve.

[0139] Example 20. The prosthetic heart valve of any example herein, particularly example 19, wherein the frame is radially expandable and collapsible between a radially expanded and radially collapsed configuration, wherein the frame comprises an hourglass shape in the radially expanded configuration when deployed within a docking device.

[0140] Example 21. A prosthetic heart valve comprising: a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration; and a plurality of leaflets mounted on an inside of the frame, wherein each leaflet comprises a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end, two first tabs disposed on opposite sides of the main body, two second tabs disposed on opposite sides of the main body, and two cutout regions disposed on opposite sides of the main body axially between a respective second tab and the cusp edge portion, wherein the free edge includes linear edges that form a peak at a midpoint of the free edge that extends away from the cusp edge portion, wherein the first tabs are folded against the second tabs, and wherein first and second tabs of adjacent leaflets are paired to form a commissure that is secured to the frame.

[0141] Example 22. A leaflet for a prosthetic valve, comprising: a main body with a free, outflow edge, a cusp edge portion, and cutout regions disposed on opposite sides of the main body, wherein the outflow edge includes a peak that extends away from the cusp edge portion, wherein the leaflet includes a wing on either side of the main body, wherein each wing is defined by an upper edge extending perpendicular to a central longitudinal axis of the leaflet and the cusp edge portion, wherein the cusp edge portion terminates at upper ends thereof at the cutout regions, and wherein side edges of the main body at least partially define the cutout regions; two first tabs disposed on opposite sides of the main body, wherein the first tabs extend laterally outward from the main body relative to the central longitudinal axis; two second tabs disposed on opposite sides of the main body and extending laterally outward from the main body; and two offsetting portions, each offsetting portion extending between a respective first tab and second tab and offsetting the respective first tab axially and laterally away from the outflow edge of the main body, wherein each first tab has opposing inner and outer edges that are parallel to one another and disposed parallel to the central longitudinal axis of the leaflet.

[0142] Example 23. A leaflet for a prosthetic valve, comprising: a main body with a free edge and a cusp edge portion, the free edge disposed at an outflow end of the leaflet; two first tabs disposed on opposite sides of the main body, wherein the first tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet, wherein each first tab has an outer edge and an inner edge disposed opposite the outer edge, wherein the inner and outer edges of each first tab are parallel to the central longitudinal axis of the leaflet; two second tabs disposed on opposite sides of the main body and extending laterally outward from the main body, wherein the second tabs are disposed closer to the cusp edgeportion than the first tabs; two cutout regions disposed on opposite sides of the main body, wherein the cutout regions are at least partially defined by side edges of the main body at least partially define the cutout regions and edges extending perpendicular to the central longitudinal axis that intersect the cusp edge portion, wherein the side edges extend in the axial direction between second tabs and upper ends of the cusp edge portion; and two offsetting portions, each offsetting portion extending between a respective first tab and second tab and offsetting the respective first tab axially and laterally away from the free edge of the main body, wherein each offsetting portion comprises an outer edge that extends between an inflow edge of the respective first tab and an outflow edge of the respective second tab.

[0143] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one inner skirt can be combined with any one or more features of another inner skirt. As another example, any one or more features of one prosthetic heart valve can be combined with any one or more features of another prosthetic heart valve.

[0144] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

Claims:

1. A prosthetic heart valve comprising:a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration; anda plurality of leaflets mounted on an inside of the frame, wherein each leaflet comprises a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end, two first tabs disposed on opposite sides of the main body, two second tabs disposed on opposite sides of the main body, and two cutout regions disposed on opposite sides of the main body axially between a respective second tab and the cusp edge portion, wherein the free edge includes linear edges that form a peak at a midpoint of the free edge that extends away from the cusp edge portion, wherein the first tabs are folded against the second tabs, and wherein first and second tabs of adjacent leaflets are paired to form a commissure that is secured to the frame.

2. The prosthetic heart valve of claim 1, wherein each leaflet comprises a central longitudinal axis, and wherein each first tab has opposing inner and outer edges that are parallel to one another and disposed parallel to the central longitudinal axis of the leaflet.

3. The prosthetic heart valve of either claim 1 or claim 2, wherein the cutout regions are partially defined by side edges of the main body, and wherein each side edge is disposed laterally inwards of a side edge of a respective second tab.

4. The prosthetic heart valve of any one of claims 1-3, wherein the cusp edge portion comprises a U-shape.

5. The prosthetic heart valve of any one of claims 1-4, wherein the frame comprises an hourglass shape in the radially expanded configuration when expanded within a docking device.

6. A leaflet for a prosthetic valve, comprising:a main body with a free, outflow edge, a cusp edge portion, and cutout regions disposed on opposite sides of the main body, wherein the outflow edge includes a peak that extends away from the cusp edge portion, wherein the leaflet includes a wing on either sideof the main body, wherein each wing is defined by an upper edge extending perpendicular to a central longitudinal axis of the leaflet and the cusp edge portion, wherein the cusp edge portion terminates at upper ends thereof at the cutout regions, and wherein side edges of the main body at least partially define the cutout regions;two first tabs disposed on opposite sides of the main body, wherein the first tabs extend laterally outward from the main body relative to the central longitudinal axis;two second tabs disposed on opposite sides of the main body and extending laterally outward from the main body; andtwo offsetting portions, each offsetting portion extending between a respective first tab and second tab and offsetting the respective first tab axially and laterally away from the outflow edge of the main body, wherein each first tab has opposing inner and outer edges that are parallel to one another and disposed parallel to the central longitudinal axis of the leaflet.

7. The leaflet of claim 6, wherein each offsetting portion has an outer edge that extends between an inflow edge of the respective first tab and an outflow edge of the respective second tab and an inner edge that comprises a straight portion and an angled portion.

8. The leaflet of claim 7, wherein the outer edge of each offsetting portion is disposed farther outward than the side edges of a respective cutout region in the lateral direction, relative to the central longitudinal axis of the leaflet.

9. The leaflet of any of claims 6-8, wherein the outflow edge comprises linear edges that are angled towards the peak.

10. The leaflet of any of claims 6-9, wherein the cusp edge portion of the main body is U-shaped.

11. A leaflet for a prosthetic valve, comprising:a main body with a free edge and a cusp edge portion, the free edge disposed at an outflow end of the leaflet;two first tabs disposed on opposite sides of the main body, wherein the first tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet, wherein each first tab has an outer edge and an inner edge disposed opposite the outeredge, wherein the inner and outer edges of each first tab are parallel to the central longitudinal axis of the leaflet:two second tabs disposed on opposite sides of the main body and extending laterally outward from the main body, wherein the second tabs are disposed closer to the cusp edge portion than the first tabs;two cutout regions disposed on opposite sides of the main body, wherein the cutout regions are at least partially defined by side edges of the main body and edges extending perpendicular to the central longitudinal axis that intersect the cusp edge portion, wherein the side edges extend in the axial direction between second tabs and upper ends of the cusp edge portion; andtwo offsetting portions, each offsetting portion extending between a respective first tab and second tab and offsetting the respective first tab axially and laterally away from the free edge of the main body, wherein each offsetting portion comprises an outer edge that extends between an inflow edge of the respective first tab and an outflow edge of the respective second tab.

12. The leaflet of claim 11, wherein the side edges of the main body are parallel to the central longitudinal axis of the leaflet.

13. The leaflet of either claim 11 or claim 12, wherein the cutout regions are disposed closer to the cusp edge portion that the second tabs in the axial direction.

14. The leaflet of any one of claims 11-13, wherein the free edge comprises angled portions that form a peak.

15. The leaflet of any one of claims 11-14, wherein the cusp edge portion comprises a curved shape.

16. The leaflet of any one of claims 11-15, wherein each side edge of the main body is disposed laterally inwards of an outer edge of a respective second tab.

17. The leaflet of claim 16, wherein each side edge of the main body is disposed laterally inwards of the outer edge of each offsetting portion.

18. A prosthetic heart valve comprising a plurality of the leaflets of any one of claims 6-17, wherein for each leaflet, the first tabs are folded over the respective second tabs.

19. The prosthetic heart valve of claim 18, wherein the cusp edge portion of each leaflet coupled to struts of a frame of the prosthetic heart valve via an inner skirt of the prosthetic heart valve, and wherein the free edge of the main body of each leaflet is free to move during operation of the prosthetic heart valve to regulate a flow of blood through the prosthetic heart valve.

20. The prosthetic heart valve of claim 19, wherein the frame is radially expandable and collapsible between a radially expanded and radially collapsed configuration, wherein the frame comprises an hourglass shape in the radially expanded configuration when deployed within a docking device.

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