Artificial Heart Valve and Artificial Heart Valve Delivery Assembly

Abstract

In some embodiments, an artificial heart valve for implantation within a native heart valve includes a radially expandable frame and a valve structure. The frame includes an annular body having an inflow end and an outflow end. The body is radially expandable between a radially compressed state and a radially expanded state. The valve structure includes a plurality of valve leaflets disposed within and coupled to the frame. The frame includes a plurality of frame anchors coupled to the body. Each frame anchor is configured to be positioned over or around a pair of two free ends of a native leaflet of the native heart valve. In some embodiments, an artificial heart valve delivery assembly includes the artificial heart valve and a delivery device for delivering the artificial heart valve to the implantation site.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 369,170, filed on July 22, 2022, which is hereby incorporated by reference in its entirety.

[0002] The present disclosure relates to embodiments of an artificial valve (e.g., an artificial heart valve) and a delivery device for implanting the artificial valve.

Background Art

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can cause severe heart dysfunction and may ultimately require repair of the native valve or replacement of the native valve with an artificial valve. Numerous repair devices (e.g., stents) and artificial valves are known, as are numerous methods for implanting these devices and valves into a human. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver medical devices to internal locations in the body that are not easily accessible by surgery or where surgery - free access is desirable.

[0004] In one specific example, an artificial heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through a patient's vasculature (e.g., through the femoral artery and aorta) to reach an implantation site within the heart. Thereafter, the artificial heart valve is expanded to its functional size, for example, by inflating a balloon on which the artificial valve is mounted on its upper surface and actuating a mechanical actuator that applies an expanding force to the artificial heart valve, or by deploying the artificial heart valve from the sheath of the delivery device such that the artificial heart valve can self - expand to its functional size.

[0005] Balloon-expandable prosthetic valves are typically preferred for replacing calcified native valves because the catheter balloon can apply sufficient expansion force to anchor the prosthetic valve frame to the surrounding calcified tissue. On the other hand, self-expanding prosthetic valves may be preferred for replacing defective non-stenotic (non-calcified) native valves, such as insufficient native valves, but can also be used to replace stenotic valves.

[0006] One problem associated with implanting a self-expandable prosthetic valve in a non-stenotic native valve is that the prosthetic valve may not be able to apply sufficient force to the surrounding tissue to resist movement of the prosthetic valve. Typically, the frame of a self-expandable prosthetic valve must be relatively long so that the upper portion of the frame can assist in anchoring the prosthetic valve within the descending aorta. Unfortunately, if future intervention is required, the upper portion of the frame can block access to the coronary ostia. Further, if it becomes necessary to remove the prosthetic valve from the patient, portions of the frame can be fixed to non-diseased regions of the aorta that can complicate removal of the prosthetic valve. Alternatively, the frame can have additional anchoring devices that can be difficult to position and deploy. SUMMARY OF THE INVENTION

[0007] Disclosed herein are artificial heart valves, delivery devices, and methods for implanting an artificial heart valve. The disclosed artificial heart valves, delivery devices, and methods can provide various features for maintaining, for example, the position and / or orientation of the artificial heart valve relative to the native annulus of the heart. Thus, the devices and methods disclosed herein can overcome, among other things, one or more deficiencies associated with typical artificial heart valves and their delivery devices.

[0008] An artificial heart valve can include a frame and a valve structure coupled to the frame. In addition to these components, the artificial heart valve can further include one or more of the components disclosed herein.

[0009] In some embodiments, the artificial heart valve may comprise a radially expandable frame having an annular body with an inflow end and an outflow end, and the body may be radially expandable between a radially compressed state and a radially expanded state.

[0010] In some embodiments, the frame may include a plurality of frame anchors coupled to the body.

[0011] In some embodiments, the artificial heart valve may be configured to be implanted within a native heart valve that includes a plurality of native valve leaflets, and each frame anchor may be configured to be positioned over or around a pair of free ends of two of the native valve leaflets.

[0012] In some embodiments, the frame anchor may be configured to engage the native valve leaflet to anchor the artificial heart valve in place against retrograde blood flow and against the native heart valve annulus.

[0013] In some embodiments, the body may include an inflow end portion that includes an inflow end, and the inflow end portion may flare radially outwardly.

[0014] In some embodiments, each frame anchor may be configured to transition from a delivery configuration to a deployed configuration to anchor the artificial heart valve within the native heart valve, and each frame anchor may be biased toward the deployed configuration.

[0015] In some embodiments, each frame anchor is substantially U-shaped when the frame anchor is in one or both of the deployed configuration and the delivery configuration.

[0016] In some embodiments, each frame anchor may include an intermediate portion and a pair of leg portions extending away from the intermediate portion, and the artificial heart valve may be configured such that when the artificial heart valve is implanted within the native heart valve, each leg portion engages a native valve leaflet of the native heart valve proximate to a native commissure of the native heart valve.

[0017] In some embodiments, the pair of leg portions can include a first leg portion and a second leg portion, and one or both of the first leg portion and the second leg portion can include an opening configured to engage the cord of the delivery device.

[0018] In some embodiments, an artificial heart valve for implantation within a native heart valve including a plurality of valve leaflets comprises a radially expandable frame and a valve structure including a plurality of valve leaflets disposed within and coupled to the frame. The frame comprises an annular body having an inflow end and an outflow end. The body is radially expandable between a radially compressed state and a radially expanded state. The valve structure is configured to regulate blood flow through the frame from the inflow end to the outflow end in one direction. The frame comprises a plurality of frame anchors coupled to the body. Each frame anchor is configured to be positioned over or around a pair of free ends of two of the native valve leaflets.

[0019] In some embodiments, an artificial heart valve for implantation within a native heart valve that includes a plurality of valve leaflets includes a radially expandable frame and a valve structure disposed within the frame and coupled to the frame that includes a plurality of valve leaflets. The frame includes an annular body having an inflow end and an outflow end. The body is radially expandable between a radially compressed state and a radially expanded state. The valve structure is configured to regulate blood flow in one direction through the frame from the inflow end to the outflow end. The frame includes a plurality of frame anchors coupled to the body. Each frame anchor includes a first leg portion, a second leg portion, and an intermediate portion. Each of the first leg portion and the second leg portion extends away from the intermediate portion. Each frame anchor is configured to bend relative to the body and transition between a delivery configuration and a deployed configuration. For each frame anchor, when the frame anchor is in the deployed configuration and when the artificial heart valve is implanted within the native heart valve, the first leg portion extends along a first valve leaflet of the plurality of native valve leaflets, the second leg portion extends along a second valve leaflet of the plurality of native valve leaflets, and the intermediate portion is positioned adjacent to a free end of each of the first valve leaflet and the second valve leaflet.

[0020] In some embodiments, the artificial heart valve includes one or more of the components recited in Examples 1-52 below.

[0021] The artificial heart valve delivery assembly can include a handle and one or more shafts coupled to the handle. In addition to these components, the artificial heart valve delivery assembly can further include one or more of the components disclosed herein.

[0022] In some embodiments, the artificial heart valve delivery assembly can include an artificial heart valve for implantation within a native heart valve that includes a plurality of native valve leaflets and a delivery device for delivering the artificial heart valve to the implantation site.

[0023] In some embodiments, the artificial heart valve can include a radially expandable frame and a valve structure disposed within and coupled to the frame and including a plurality of valve leaflets.

[0024] In some embodiments, the frame can comprise an annular body having an inflow end and an outflow end.

[0025] In some embodiments, the valve structure can be configured to regulate blood flow through the frame from the inflow end to the outflow end in one direction.

[0026] In some embodiments, the frame can include a plurality of frame anchors coupled to the body.

[0027] In some embodiments, each frame anchor can be configured to be positioned over or around a pair of free ends of two of the native valve leaflets.

[0028] In some embodiments, the delivery device can include a delivery capsule configured to accommodate the artificial heart valve in a radially compressed state and a plurality of cords.

[0029] In some embodiments, each cord of the plurality of cords can be removably connected to a respective frame anchor of the artificial heart valve and configured to apply a restraining force to each respective frame anchor.

[0030] In some embodiments, for each cord and each respective frame anchor, the frame anchor can include an opening and the cord can extend through the opening when the artificial heart valve is accommodated within the delivery capsule.

[0031] In some embodiments, each frame anchor can be configured to transition from a delivery configuration to a deployed configuration to anchor the artificial heart valve within the native heart valve.

[0032] In some embodiments, for each cord and each frame anchor, the cord may be configured to maintain the frame anchor in a delivery configuration while the cord applies a restraining force to the frame anchor, and the frame anchor may automatically transition from the delivery configuration to a deployed configuration when the cord no longer applies a restraining force to the frame anchor.

[0033] In some embodiments, an artificial heart valve delivery assembly comprises an artificial heart valve for implantation within a native valve including a plurality of native valve leaflets, and a delivery device for delivering the artificial heart valve to an implantation site. The artificial heart valve comprises a radially expandable frame and a valve structure. The frame comprises an annular body having an inflow end and an outflow end. The body is radially expandable between a radially compressed state and a radially expanded state. The valve structure is disposed within and coupled to the frame and comprises a plurality of valve leaflets configured to regulate blood flow in one direction through the frame from the inflow end to the outflow end. The frame comprises a plurality of frame anchors coupled to the body. Each frame anchor is configured to be positioned over or around a pair of free ends of two of the native valve leaflets. The delivery device comprises a delivery capsule configured to house the artificial heart valve in a radially compressed state, and a plurality of cords. Each cord is removably connected to a respective frame anchor of the artificial heart valve and is configured to apply a restraining force to each respective frame anchor.

[0034] In some embodiments, the artificial heart valve delivery assembly comprises one or more of the components listed in Examples 53-63 below.

[0035] The various innovations in this disclosure can be used in combination or individually. This summary is provided to introduce, in a simplified form, a selection of concepts that are further described in the following 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 invention will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0036]

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[0037] General Considerations For the purposes of this specification, specific aspects, advantages, and novel features in the examples of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as being in any way limiting. Instead, this disclosure is directed to all novel and non-obvious features and aspects related to the various disclosed examples, alone, in various combinations with each other, and in various sub-combinations with each other. The methods, apparatuses, and systems are not limited to any specific aspect, feature, or combination thereof, and the disclosed examples do not require the presence of any one or more specific advantages or the solution of any problems.

[0038] In some of the disclosed examples, operations are described in a particular sequential order for presentation convenience. However, it should be understood that this mode of description encompasses permutations unless the specific language described below requires a particular order. For example, operations described sequentially may, in some cases, be permuted or may be executed simultaneously. Additionally, for simplicity, the accompanying drawings may not show various aspects in which the disclosed method can be used in combination with other methods. Additionally, in the description, terms such as "provide" or "achieve" are sometimes used to describe the disclosed method. These terms are high-level abstractions regarding the actual operations to be performed. The actual operations corresponding to these terms may vary depending on a particular implementation and would be readily recognizable to one of ordinary skill in the art.

[0039] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural 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 connected and does not exclude the presence of intervening elements between coupled or associated members unless a specific contrary language is provided.

[0040] As used herein, the term "proximal" refers to the position, orientation, or portion of the device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to the position, orientation, or portion of the device that is further away from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device away from the implantation site and towards the user (e.g., out of the patient's body), while distal movement of the device is movement of the device away from the user and towards the 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 explicitly defined.

[0041] As used herein, the term "substantially" means the recited value, and / or characteristic, and any value, and / or characteristic that is at least 75% of the recited value, and / or characteristic. Equally, the term "substantially" means the recited value, and / or characteristic, and any value, and / or characteristic that differs from the recited value, and / or characteristic by up to 25%. For example, "at least substantially parallel" refers to directions that are completely parallel and directions that diverge by up to 22.5 degrees.

[0042] As used herein, "e.g." means "for example" and "i.e." means "that is". Examples of the disclosed technology

[0043] This specification describes embodiments of implantable expandable medical devices, such as artificial heart valves. The artificial heart valve is configured to be implanted in the native valve annulus of a patient's heart. To maintain the position and / or orientation of the artificial heart valve relative to the native valve annulus, the artificial heart valve includes a flared inflow end configured to engage the native valve annulus and a plurality of frame anchors configured to engage the native valve leaflets adjacent to the commissures of the native valve leaflets. The artificial heart valve is particularly suitable for implantation within the native aortic valve or pulmonary valve. However, the artificial heart may also be adapted to be implanted in other native valves of the heart (mitral valve and tricuspid valve).

[0044] The artificial valves disclosed herein can be radially compressible and radially expandable between a radially compressed state and a radially expanded state. Thus, the artificial valve can be in a radially compressed state at the time of delivery and can be coiled onto an implant delivery device or held by an implant delivery device, and then can be expanded to a radially expanded state after the artificial valve reaches the implantation site. It is understood that the artificial valves disclosed herein can be used with various implant delivery devices and can be implanted via various delivery procedures, and examples of those artificial valves will be described in more detail below.

[0045] FIG. 1 shows an exemplary artificial valve 10 according to one embodiment. Any artificial valve disclosed herein is adapted to be implanted in the native aortic valve annulus, but in other embodiments can be adapted to be implanted in other native valve annuli of the heart (pulmonary valve, mitral valve, and tricuspid valve). The disclosed artificial valves can also be implanted inside the pulmonary artery (to replace the function of the diseased pulmonary valve), the superior vena cava, or the inferior vena cava (to replace the function of the diseased tricuspid valve), or inside blood vessels communicating with the heart, including various other veins, arteries, and blood vessels of the patient. The disclosed artificial valves can also be implanted inside previously implanted artificial valves (which can be artificial surgical valves or artificial transcatheter heart valves) in a valve-in-valve procedure.

[0046] In some embodiments, the disclosed artificial valve can be implanted within a natural heart valve, or within a docking device, or an anchor device, that is implanted within a blood vessel. For example, in one embodiment, the disclosed artificial valve can be implanted within a docking device that is implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed in, for example, U.S. Patent Publication No. 2017 / 0231756, which is incorporated herein by reference. In another embodiment, the disclosed artificial valve can be implanted within a natural mitral valve, or within a docking device that is implanted within a natural mitral valve, as disclosed in, for example, PCT Publication No. WO2020 / 247907, which is incorporated herein by reference. In another embodiment, the disclosed artificial valve can be implanted within a docking device that is implanted within the superior vena cava, or the inferior vena cava, to replace the function of a diseased tricuspid valve, as disclosed in, for example, U.S. Patent Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0047] As described above, FIG. 1 shows an artificial heart valve 10 that is an example of an artificial heart valve known in the art, and FIGS. 2-4 show aspects of an artificial heart valve 50 according to the present disclosure. In some embodiments, the artificial heart valve (e.g., artificial heart valve 10, and / or artificial heart valve 50) is a self-expanding valve that is delivered to the deployment site in a radially compressed state via a delivery device. When advanced from the delivery capsule at the distal end of the delivery device (as discussed with reference to FIGS. 9A-10B below), the artificial valve can radially self-expand to its functional size.

[0048] As shown in FIG. 1, the artificial heart valve 10 includes a stent, or frame 12, and a valve structure 14 (e.g., valve leaflets, or septal valve) supported by the frame. The frame 12 can have a plurality of struts 16 that are interconnected and extend circumferentially, arranged in a lattice pattern, and form a plurality of vertices 18 at the inflow end 20 and the outflow end 22 of the frame 12, respectively. The valve structure 14 is configured to regulate the flow of blood through the artificial heart valve 10 from the inflow end 20 to the outflow end 22.

[0049] The frame 12 can include a plurality of angularly spaced posts 24 extending from each vertex 18 at the outflow end of the frame 12. The frame 12 of the illustrated embodiment includes three such posts 24, although a greater or lesser number of posts can be used. In one implementation, the frame 12 can have posts extending from all vertices 18 at the outflow end of the frame. Each post 24 can have an eyelet, or aperture 26, which can be used to form a releasable connection with a delivery device, such as via the use of one or more cords, or tethers 118, as further described below (see FIGS. 9A - 9B).

[0050] In other embodiments, the aperture 26 can be formed at the inlet (or inflow) end 20 of the frame 12, and other delivery device configurations, or other delivery techniques, require an aperture at the inlet end of the frame, such as a transapical delivery approach.

[0051] Frame 12 can be formed from any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) known in the art, or from self-expanding materials (e.g., nitinol). When constructed from a plastically expandable material, frame 12 (and thus artificial heart valve 10) can be crimped in a radially compressed state on a delivery catheter and then expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. Frame 12 (and thus artificial heart valve 10), when constructed from a self-expandable material, can be crimped to a radially compressed state and restrained in the compressed state by insertion into the sheath of a delivery catheter or equivalent mechanism. Once inside the body, the artificial heart valve can be advanced from the delivery sheath, thereby enabling the artificial heart valve to expand to its functional size.

[0052] Suitable plastically expandable materials that can be used to form the frames (e.g., frame 12) disclosed herein include metal alloys, polymers, or combinations thereof. Exemplary metal alloys can include one or more of nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some cases, frame 12 can include stainless steel. In some cases, frame 12 can include cobalt chromium. In some cases, frame 12 can include nickel-cobalt-chromium. In some embodiments, frame 12 includes a nickel-cobalt-chromium-molybdenum alloy such as MP35N (trademark) (a trade name of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N (trademark) / UNS R30035 includes 35 wt% nickel, 35 wt% cobalt, 20 wt% chromium, and 10 wt% molybdenum.

[0053] In certain embodiments, the prosthetic heart valve 10 is a self-expanding heart valve, and the frame 12 is made of a superelastic self-expanding material (e.g., a nickel-titanium alloy such as nitinol) known in the art. When used with a delivery device 100 (Figs. 9-10), the prosthetic valve 10 can self-expand from a radially compressed state to a radially expanded state as it advances from the delivery capsule (e.g., delivery sheath) of the delivery device. In particular, Fig. 1 shows the prosthetic valve 10 in an expanded state.

[0054] The valve structure 14 can include a plurality of valve leaflets 28. The valve structure typically comprises three valve leaflets 28 arranged in a tricuspid configuration, although a greater or lesser number of valve leaflets 28 can be used. The valve leaflets 28 can be made of any of a variety of suitable materials, including natural tissue (e.g., bovine pericardium, or pericardium from other sources) or synthetic materials (e.g., polyurethane). Adjacent sides at the outflow edges (upper edges in the drawings) of adjacent valve leaflets can be fixed to each other to form a commissure 30 of the valve structure that can be fixed to the frame with suture 32.

[0055] The prosthetic valve 10 can further include an inner skirt 34 attached inside the frame 12. The skirt 34 helps establish a seal with the surrounding tissue after implantation. The skirt 34 can also be used to attach a portion of the valve leaflet 28 to the frame 12. For example, in the illustrated embodiment, the inflow edge (lower edge in the drawings) of the valve leaflet can be sutured to the skirt 34 along suture line 36. The skirt 34 can be connected directly to the frame 12 by sutures or the like. Although not shown, the prosthetic valve 10 can include an outer skirt attached outside the frame, instead of or in addition to the inner skirt 34, to further seal the prosthetic valve against the surrounding tissue.

[0056] The inner skirt, and / or the outer skirt can be formed entirely or partially from any suitable biological material, synthetic material (e.g., any of various polymers), or combinations thereof. In some embodiments, the inner skirt, and / or the outer skirt can include a fabric having woven threads or fibers, such as in the form of a textile, braid, or knit. In some embodiments, the fabric can have a nap or pile of fuzz. Exemplary fabrics having a nap or pile of fuzz include velour, velvet, velveteen, corduroy, terry cloth, fleece, and the like. In some embodiments, the inner skirt, and / or the outer skirt can include a fabric without woven threads or fibers, or randomly woven threads or fibers, such as felt or electrospun fabric. Exemplary materials that can be used to form such fabrics (with or without woven threads or fibers) include, but are not limited to, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide, and the like. In some embodiments, the inner skirt, and / or the outer skirt can include a non-textile material, or non-fabric material, such as a film made from any of various polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyether ether ketone (PEEK), polyurethane (e.g., thermoplastic polyurethane (TPU)), and the like. In some embodiments, the inner skirt, and / or the outer skirt can include a sponge material, or foam, such as polyurethane foam. In some embodiments, the inner skirt, and / or the outer skirt can include a natural tissue, such as a pericardium (e.g., bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0057] Exemplary configurations of the artificial heart valve are further disclosed in WIPO Publication No. WO2021 / 195090, as well as U.S. Patent Application Publication Nos. 2014 / 0343670, 2012 / 0123529, 2010 / 0036484, and 2010 / 0049313, the disclosures of which are incorporated herein by reference.

[0058] FIG. 2 shows an artificial heart valve 50 according to the present disclosure, and FIGS. 3-4 show the stent, or frame 52a, of the artificial heart valve 50. In particular, FIGS. 2-4 show the artificial heart valve 50, and / or the frame 52a, in a radially expanded state. As used herein, the terms "expanded state" and / or "compressed state" may be used to refer to either or both of the artificial heart valve 50 and / or the frame 52a.

[0059] Unless otherwise specified, the artificial heart valve 50 and / or the frame 52a may share any suitable components, properties, features, etc. with the artificial heart valve 10 of FIG. 1. For example, as shown in FIGS. 2-4, the frame 52a can include a base frame structure, or body 53, including a plurality of circumferentially extending struts 56, vertices 58, an inflow end 60, and an outflow end 62, each of which may share any properties with the struts 16, vertices 18, inflow end 20, and / or outflow end 22 of the frame 12. Similarly, and as shown in FIGS. 2-4, the artificial heart valve 50 can include a valve structure 54 including a plurality of valve leaflets 68 that form a plurality of commissures 70, each of which may share any properties with the valve structure 14, valve leaflets 28, and commissures 30 of the artificial heart valve 10. The valve leaflets 68 may be assembled to the frame 52a in the same manner as the valve leaflets 28 of the artificial valve 10. For example, the leading edge of the valve leaflets 68 can be sutured to the inner skirt 34 along a suture line (not shown in FIG. 2). Also, the commissures of the valve leaflets 68 can be coupled to the frame 52a, such as by suturing commissure tabs of the valve leaflets to the struts of the frame in the manner shown in FIG. 1. However, of course, the valve leaflets 68 can be assembled to the frame using any known technique or mechanism known in the art.

[0060] Furthermore, as shown in FIG. 2, the artificial heart valve 50 may include an outer skirt 78 attached to the outside of the main body 53 of the frame, which may share any applicable features and / or characteristics with the inner skirt 34 of the artificial heart valve 10. In particular, the outer skirt 78 may be fixed to the outside of the main body 53, such as by sutures. When present, the outer skirt 78 may be configured to seal the artificial heart valve 50 against the surrounding tissue. As shown in FIG. 2, the outer skirt 78 may cover all or at least substantially all of the outer surface of the main body 53 (and thus is hidden in FIG. 2). In other embodiments, the outer skirt 78 may cover only a portion of the outer surface of the main body 53. For example, the outer skirt 78 may extend from the inflow end 60 of the frame to an axial position between the inflow end 60 and the outflow end 62. Desirably, the outer skirt 78 extends over and covers at least the flared inflow end portion of the frame to seal against the tissue of the native valve annulus.

[0061] As shown in FIG. 3, the frame 52a has a main body 53 that includes an inflow end portion, or region 66, an outflow end portion, or region 65, and a waist portion, or region 64, that extends between the inflow end portion and the outflow end portion. The outflow end portion 65 is generally cylindrical, and the inflow end portion 66 is flared outwardly at least when the frame 52a is in an expanded state. In particular, as shown in FIG. 3, when the frame 52a is in an expanded state, the diameter of the inflow end portion 66 increases from the waist portion 64 to the inflow end 60. Specifically, the outflow end 62 may have a diameter D1, and the inflow end 60 may have a diameter D2 that is larger than D1.

[0062] As a more specific example, D2 may be at least 110% of D1, at least 125% of D1, at least 150% of D1, at least 175% of D1, at least 200% of D1, or up to 225% of D1, up to 180% of D1, up to 160% of D1, up to 140% of D1, and / or up to 120% of D1.

[0063] In certain embodiments, for an artificial valve intended for use with an annulus of 22 mm to 24 mm, the diameter D2 is from about 28 millimeters (mm) to about 32 mm, with 30 mm being a particular embodiment, and the diameter D1 is from about 24 mm to about 28 mm, with 26 mm being a particular embodiment. In certain embodiments, the artificial valve has a length measured between the inflow end 60 and the outflow end 62, which is from about 20 mm to about 24 mm, with 22 mm being a particular embodiment.

[0064] In some embodiments, such as the embodiment of FIG. 3, the diameter of the body 53 is constant, or substantially constant (e.g., within 10%) along the outflow end portion 65 and / or the waist region 64. Additionally or alternatively, the diameter of the body 53 can increase gradually (e.g., monotonically) from the diameter D1 of the outflow end 62 to the diameter D2 of the inflow end 60.

[0065] In alternative embodiments, the body 53 of the frame can have various other shapes or configurations. For example, the outflow end portion 65 can be flared outward such that the diameter of the outflow end portion 65 increases in the direction extending from the waist region 64 to the outflow end 62. In yet further alternative embodiments, the body 53 can have the same shape as the frame 12 of FIG. 1. In still other embodiments, the body 53 can be cylindrical and can have a constant or substantially constant diameter from the inflow end 60 to the outflow end 62.

[0066] The increase in the diameter of the inflow end 60 can assist in anchoring the artificial heart valve 50 to the annulus of a native valve (e.g., the native aortic valve) when implanted in the heart. In particular, D2 is desirably larger than the diameter of the native annulus in which the artificial heart valve 50 is implanted. In this way, the overall shape of the frame 52a assists in holding the artificial heart valve 50 in the implantation site.

[0067] More specifically, FIGS. 5-6 show an artificial heart valve 50 implanted within the aortic valve annulus 42 of the aorta 41 of the heart 40 such that the flared inflow end 60 extends beneath the aortic valve annulus 42. The artificial heart valve 50 is at least partially retained within the native valve by the radially outward force of the artificial heart valve 50 against the surrounding tissue of the aortic valve annulus 42 and by the geometric shape of the frame 52a. Specifically, the flared inflow end region 66 is shaped to conform to the aortic valve annulus 42 and may extend to a sub-valvular position to better resist axial displacement of the artificial heart valve 50 mainly in the upstream direction (towards the aorta). In certain embodiments, the inflow end 60 of the frame may be positioned within the left ventricle when the artificial valve 50 is implanted. In some embodiments, the radially outward force of the inflow end region 66 against the native annulus can also assist in retaining the artificial valve against axial displacement in the downstream direction (towards the left ventricle). Further, as shown in FIG. 5, the artificial heart valve 50 can form a substantially fluid-tight seal with the aortic valve annulus 42 through contact between the aortic valve annulus 42 and the flared inflow end region 66 of the frame 52a (and / or the outer skirt 78 within this region) to prevent or minimize paravalvular leakage.

[0068] The frame 52a of the artificial heart valve 50 may further include dedicated features and / or structures for anchoring the artificial heart valve 50 to the native aortic valve annulus 42. In particular, as shown in FIGS. 2-4, the frame 52a of the artificial heart valve 50 includes a plurality of frame anchors 80a coupled to the body 53 at a position axially spaced from the inflow end of the frame. The frame anchors 80a are configured to engage the native valve leaflets 44 of the aortic valve at or adjacent to the native commissures 45 to assist in retaining the artificial heart valve 50 in a predetermined position relative to the aortic valve annulus 42 against retrograde blood flow.

[0069] The number of frame anchors 80a preferably corresponds to the number of natural commissures 45 of the native valve into which the prosthetic valve is implanted. For most patients, the native aortic, tricuspid, and pulmonary valves have three natural commissures. Thus, for implantation in the native aortic, tricuspid, or pulmonary valve, the frame can have three frame anchors 80a corresponding to the three natural commissures. For implantation in a bicuspid native aortic valve or native mitral valve, the frame can have two frame anchors 80a.

[0070] In other embodiments, the frame 52a can have fewer frame anchors 80a than the number of natural commissures of the native valve into which the prosthetic valve is implanted, such as, for example, one or two frame anchors 80a for a native valve having three commissures, or one frame anchor 80a for a native valve having two commissures.

[0071] In yet other embodiments, the frame 52 can have more frame anchors 80a than the number of natural commissures of the native valve into which the prosthetic valve is implanted. Such a configuration can facilitate positioning each frame anchor 80a at each natural commissure within a native valve where the natural commissures are not evenly circumferentially spaced from one another. For example, the frame can have a plurality of primary frame anchors corresponding to the number of natural commissures and one or more secondary frame anchors, each of which is circumferentially positioned between two primary frame anchors. If it is determined that one or more of the primary anchors do not align with the natural commissures, the frame can be positioned such that one or more of the secondary anchors align with those natural commissures.

[0072] In the illustrated embodiment, as shown in FIGS. 2 and 6, each frame anchor 80a is located on the body of the frame at a position circumferentially aligned with the commissure 70 of the prosthetic valve. In this way, when the prosthetic valve 50 is implanted within the native aortic valve, each frame anchor 80a is located at the native commissure 45, and each commissure 70 of the prosthetic valve rotates and aligns with one of the native commissures 45. In this position, each commissure 70 of the prosthetic valve 50 is offset in the rotational direction from the coronary ostium 47. In this manner, the frame anchor 80a functions as a positioning / alignment member for rotating and aligning the prosthetic valve with respect to the coronary ostium.

[0073] Positioning the commissure at a location offset in the rotational direction from the coronary ostium 47 has several potential benefits. For example, the commissure of the prosthetic valve located in front of the coronary ostium may block or interfere with coronary catheterization in subsequent procedures. On the other hand, positioning the commissure 70 of the prosthetic valve at a position offset in the rotational direction from the coronary ostium 47 can facilitate access to the coronary artery, such as in subsequent coronary angiography or angioplasty. Further, when a replacement prosthetic valve is implanted within a previously implanted prosthesis 50 (in a "valve-in-valve" procedure), it may be desirable to modify the leaflet 68 of the previously implanted valve, such as by cutting the leaflet 68 or forming an opening in the leaflet 68 at a position between the commissures, in order to increase access to the coronary artery. The physician can more easily access the leaflet 68 using a medical device for modifying the leaflet when the previously implanted prosthetic valve is in this orientation.

[0074] In other embodiments, the frame anchor 80a can be positioned on the body of the frame at a position offset circumferentially from the commissure 70.

[0075] When the artificial valve 50 is implanted, the position of the native valve leaflet 44 relative to the frame 52a and / or the frame anchor 80a can vary depending on the patient's anatomy and / or the condition of the native valve leaflet 44. For simplicity, FIG. 6 shows each native valve leaflet 44 as contacting the outer surface of the frame 52a and / or the outer skirt 78, which can be the case for a stenotic (calcified) native valve leaflet 44.

[0076] However, in other embodiments, each native valve leaflet 44 may extend relative to the frame anchor 80a and / or the frame 52a in any of a variety of manners depending on the patient's anatomy and the condition of the native valve leaflet. For example, each native valve leaflet 44 may extend between adjacent frame anchors 80a such that each native valve leaflet 44 is radially spaced in a region proximate to the outflow end 62, which can be the case for a non-stenotic (non-calcified) native valve leaflet 44, from the outer surface of the frame anchor 80a and from the outer surface of the frame 52a.

[0077] Each frame anchor 80a may be attached to the body 53 of the frame 52a at any of a variety of positions, such as at any position along the waist portion 64 or the outflow end portion 65. In the embodiments of FIGS. 3 and 7A - 7C, each frame anchor 80a is attached to the body 53 at the intersection of the four struts 56 at a position spaced from each of the inflow end 60 and the outflow end 62. Specifically, in the embodiments of FIGS. 3 and 7A - 7C, each frame anchor 80a is attached to the body 53 at a position spaced from the outflow end 62 by a row of struts 56. In other embodiments, each frame anchor 80a may be attached to the body 53 at the intersection of the struts 56 at the outflow end 62 (e.g., the outflow apex 58), or may be attached to a single strut 56.

[0078] In some embodiments, as shown in FIGS. 3 and 7A, the frame anchors 80a can be evenly distributed around the circumference of the body 53. In particular, in the embodiments of FIGS. 3 and 7A, the body 53 includes 12 outflow vertices 58, and each frame anchor 80a is attached to the body 53 between a corresponding pair of outflow vertices 58 such that each pair of adjacent frame anchors 80a is separated by four outflow vertices 58. However, this is not required, and furthermore, it is within the scope of the present disclosure that the frame anchors 80a can be unevenly distributed around the circumference of the body 53.

[0079] Each frame anchor 80a can be coupled to the body 53 in any suitable manner. In some embodiments, each frame anchor 80a is formed of the same material as the body 53, and the frame anchor 80a can be integrally formed with the body 53. For example, the body 53 and the frame anchor 80a can be formed (e.g., laser cut) from the same piece of material (e.g., a nitinol piece). In other embodiments, each frame anchor 80a and the body 53 can be formed separately, and the frame anchor can then be joined to the body 53. Various techniques and mechanisms can be used to connect the frame anchor 80a to the body 53, such as welding the frame anchor to the body, adhesively bonding the frame anchor to the body, or using mechanical connectors such as sutures, screws, rivets, pins, or various other connection means.

[0080] In the embodiment of FIG. 2, each frame anchor 80a is coupled to the body 53 such that the outer skirt 78 extends at least partially between each frame anchor 80a and the body 53. In particular, the outer skirt 78 can include holes, notches, openings, apertures, etc. at the location where each frame anchor 80a is attached to the body 53.

[0081] In some embodiments, and as shown in FIG. 11, each frame anchor 80a may be at least partially covered, or substantially covered (e.g., wrapped) by a protective cover 94 that protects the native valve cusp from directly contacting the frame anchor 80a. In such embodiments, the protective cover 94 can minimize or prevent trauma to the patient's native tissue by avoiding direct contact between the metal anchor and the tissue. When present, the protective cover 94 may include various materials and / or may be any of them, examples of which include any of various synthetic materials or native tissues. For example, the cover may be in the form of a fabric (e.g., a fabric formed from PET fabric or other types of synthetic fibers), or a non-woven fabric, such as a layer of polymeric material (e.g., a layer of thermoplastic polyurethane (TPU)), or a layer of foam or sponge (e.g., a polyurethane foam or a hydrogel foam). Additionally, or alternatively, the protective cover 94 may be formed from the same material as the inner and / or outer skirts of the prosthetic valve 10. However, this is not required for all embodiments, and it is also within the scope of the present disclosure for each frame anchor 80a not to be covered.

[0082] In the embodiments of FIGS. 2-4, each frame anchor 80a includes an intermediate portion 82 and a pair of leg portions 84 extending spaced apart from the intermediate portion 82. Thus, each frame anchor 80a of the illustrated embodiment is U-shaped or substantially U-shaped, although the anchor may have various other shapes, such as V-shaped, in other embodiments. In the illustrated embodiment, the intermediate portion 82 can be fixed to the frame and may thus be referred to as the fixed portion of the frame anchor 80a. The leg portions 84 can move (e.g., pivot) between a delivery configuration (FIGS. 7A and 7B) and a deployed configuration (FIGS. 3 and 7C).

[0083] As shown in FIGS. 7A and 7B, in the delivery configuration, each leg portion 84 extends downstream toward the outflow end 62 of the frame and away from the intermediate portion 82. In some embodiments, when each frame anchor 80a is in the delivery configuration, each leg portion 84 extends from the intermediate portion 82 toward the outflow end 62 of the frame and may continue beyond the outflow end 62 of the frame. As shown in FIGS. 3 and 7C, in the deployed configuration, each leg portion 84 extends away from the intermediate portion 82 toward the inflow end 60 of the frame.

[0084] The detailed views of FIGS. 7B-7C show an example of a pattern in which each frame anchor 80a can transition from a delivery configuration (FIG. 7B) to a deployed configuration (FIG. 7C). Specifically, in the embodiments of FIGS. 7B-7C, each leg portion 84 pivots with respect to the intermediate portion 82 as the frame anchor 80a transitions from the delivery configuration to the deployed configuration, as indicated by arrow 90. More specifically, each leg portion may be configured to pivot about an axis perpendicular to the plane extending in contact with the body 53, and the frame anchor 80a is attached to the body 53. In such embodiments, each leg portion 84 may be integrally formed with the intermediate portion 82 such that the leg portion 84 can bend or deform as it transitions from the delivery configuration to the deployed configuration.

[0085] In certain embodiments, the frame anchor 80a can be formed from a shape memory material, such as nitinol. When formed from a shape memory material, the anchor 80a can be set in the deployed configuration. Thus, when the prosthetic valve 50 is loaded onto the delivery device for delivery into a patient's body, the frame anchor 80a is deformed into the delivery configuration and can be held in the delivery configuration by a retaining element (e.g., a tether) of the delivery device. When released from the retaining element at or near the implantation site, the anchor member can automatically return to the deployed configuration under its own elasticity.

[0086] As shown in FIGS. 2-3 and 7A-7C, each leg portion 84 can include an eyelet, or aperture 86, configured to engage a tether of the delivery device to selectively hold the leg portion 84 in a delivery configuration against the inherent spring force biasing the leg portion into a deployed configuration. When the prosthetic valve is loaded onto the delivery device, the tether is routed through the aperture 86 of each leg portion and pulled in the proximal direction to bend the leg portion 84 into the delivery configuration. During delivery through the patient's vasculature, the tether can be held constant to hold the leg portion in the delivery configuration. During (or alternatively, before or after) deployment of the frame body 53, the tension of the tether can be released to allow the leg portion 84 to return to the deployed configuration under its own elasticity, after which the tether can be removed from the leg portion 84. Examples of delivery devices and methods for implanting prosthetic valves are described in further detail below.

[0087] In other embodiments, the frame anchor 80a can be formed from a plastically deformable material such as stainless steel, cobalt-chromium alloy, etc., in which case the frame anchor 80a can be plastically deformed from the delivery configuration to the deployed configuration at or near the implantation site, such as by the actuation of components of the delivery device.

[0088] In the deployed configuration, each frame anchor 80a is configured to be disposed around the free ends of a pair of native valve leaflets in or near a commissure. As described above, FIGS. 5-6 illustrate an example in which the artificial heart valve 50 is implanted within the native aortic valve annulus 42 of the heart 40. In the example of FIGS. 5-6, each frame anchor 80a is in the deployed configuration and is disposed at the commissure 45 around the free ends of a pair of native valve leaflets 44. Thus, when the artificial heart valve 50 is implanted into the aortic valve annulus 42, for each frame anchor 80a, the intermediate portion 82 is positioned adjacent to or opposite the free ends of the pair of valve leaflets 44, and one of the leg portions 84 extends along one of the valve leaflets 44, and the other leg portion 84 extends along the other valve leaflet of the same native commissure 45. In this way, the frame anchor 80a can assist in holding the artificial valve within the native aortic valve by resisting movement of the artificial valve in the upstream direction (toward the left ventricle) against retrograde blood flow.

[0089] In some embodiments, the leg portions 84 can be configured to clamp a pair of native valve leaflets or sandwich a pair of valve leaflets between the leg portions. In other words, the lateral spacing between the leg portions 84 can be sized such that when the frame anchor is disposed around the pair of valve leaflets, the leg portions 84 exert a clamping force against the adjacent surfaces of the valve leaflets. In this way, the leg portions 84 engage and frictionally engage the valve leaflets between the leg portions via the clamping force applied to the valve leaflets by the leg portions. When the frame anchor is formed of a shape memory material, the leg portions 84 can be configured to clamp onto the pair of valve leaflets when transitioning from the delivery configuration to the deployed configuration. When the frame anchor is formed of a plastically deformable material, the leg portions 84 can be pressed against the adjacent surfaces of the valve leaflets when transitioning from the delivery configuration to the deployed configuration. When configured to engage the adjacent surfaces of the pair of valve leaflets, the leg portions 84 can be referred to as the valve leaflet engagement portion of the frame anchor 80a.

[0090] In the embodiments of FIGS. 2-7C, each frame anchor 80a, and / or its leg portion 84, is positioned adjacent to (e.g., immediately adjacent and / or in contact with) the body 53 when the frame anchor 80a is in the deployed configuration.

[0091] In other embodiments, at least a portion of each frame anchor 80a (e.g., its leg portion 84) may be spaced apart from the body 53 when the frame anchor 80a is in the deployed configuration. In particular, such a configuration may facilitate positioning the artificial heart valve 50 relative to the aortic valve annulus 42 such that each frame anchor 80a can engage each pair of native valve leaflets 44 with a minimum of interference from the body 53. In some such embodiments, each leg portion 84 may be coupled to the body 53 via a standoff member that spaces at least a portion of the frame anchor 80a from the body 53. For example, the standoff member may extend between the intermediate portion 82 and the body 53, or the frame anchor 80a (and / or its intermediate portion 82) may include the standoff member. In some embodiments, each standoff member may include, and / or be, a spacer strut that extends between the body 53 and the intermediate portion 82.

[0092] FIGS. 8A-8C show a frame 52b of an artificial heart valve 50 according to another embodiment. The frame 52b includes a body 53 (described above) and a plurality of frame anchors 80b coupled to the body. The frame 52b may share any suitable components, features, configurations, etc. with the frame 52a, such as the body 53. The soft components of the artificial valve 50 (e.g., leaflets, inner skirt, and / or outer skirt) are not shown in FIGS. 8A-8C for purposes of illustration, but they may be the same as those described above in connection with FIG. 2. In certain embodiments, the frame 52b is identical to the frame 52a except for the differences between the frame anchors 80b and the frame anchors 80a, which are described below.

[0093] Each frame anchor 80b may share any suitable components, features, configurations, etc. with the frame anchor 80a disclosed herein, except that each frame anchor 80b is connected to the main body 53 of the frame by one of the leg portions 84 instead of the intermediate portion 82. Thus, in the embodiments of FIGS. 8A-8C, the leg portion 84 includes a first leg portion 84a (which may be referred to as the fixed portion of the frame anchor 80b) connected to the main body 53 and a second leg portion 84b not connected to the main body 53.

[0094] FIGS. 8A-8B show each frame anchor 80b in the delivery configuration, while FIG. 8C shows the frame anchor 80b in the deployed configuration. In the delivery configuration, each frame anchor 80b may be straight or substantially straight and may extend downstream from the position where the first leg portion 84a is connected to the main body 53. In particular, as shown in FIG. 8B, when the frame anchor 80b is in the delivery configuration, the first leg portion 84a and the second leg portion 84b may be substantially in the same straight line.

[0095] As shown in FIGS. 8B-8C, each frame anchor 80b is configured to transition from the delivery configuration to the deployed configuration via pivoting and / or bending of the intermediate portion 82 and / or the second leg portion 84b relative to the first leg portion 84a in the direction indicated by the arrow 92. More specifically, the intermediate portion 82 and / or the second leg portion 84b may be configured to pivot about an axis perpendicular to the plane extending in contact with the main body 53 to which the frame anchor 80b is attached. In the deployed configuration, the frame anchor 80b forms a U-shape or a substantially U-shape, and the ends of both leg portions 84a, 84b face towards the inlet end 60 of the main body 53.

[0096] As described above with respect to the frame anchor 80a, the frame anchor 80b can be made of a shape memory material and can be shape-set in the delivery configuration shown in FIGS. 8A and 8B. The frame anchor 80b can be held in the delivery configuration by a retaining element of the delivery device, such as a tether, as further described below. Each frame anchor 80b can include an opening 86 in the leg portion 84b to receive a retaining element of the delivery device. Alternatively, the anchor 80b can be made of a plastically deformable material and can be deformed by a delivery device component to transition from the delivery configuration to the deployed configuration.

[0097] As described above, the artificial heart valve 50 can be delivered to the implantation site through the patient's vasculature via a delivery device. FIGS. 9A-9B show a distal portion of an example of a delivery device 100 having an artificial heart valve 50 supported within the delivery device 100. However, it should be understood that the delivery device 100 can also be utilized to support and / or transport any other artificial heart valve according to the present disclosure. Further, it is within the scope of the present disclosure that any of the artificial heart valves disclosed herein can be transported to the implantation site via any suitable delivery device, including a delivery device not specifically disclosed herein.

[0098] In the example of FIGS. 9A-9B, the delivery device 100 includes a first shaft 102 (the outer sheath, or outer shaft 102, of the illustrated example), the distal end portion of which forms a delivery capsule 102d that houses the artificial heart valve 50 in a radially compressed state. Alternatively, the delivery capsule 102d can be a separate component coupled to the first shaft 102. For simplicity, FIGS. 9A-9B represent the artificial heart valve 50 as the frame 52b, but it should be understood that the artificial heart valve 50 housed within the delivery capsule 102d also includes components such as the outer skirt 78 and the valve structure 54 shown in FIG. 2.

[0099] In the embodiments of FIGS. 9A-9B, the delivery device 100 further includes a second shaft 108 (the inner shaft 108 of the illustrated embodiment) that extends through the artificial heart valve 50 and supports the nose cone 110 of the delivery device 100. Specifically, the nose cone 110 can be connected or attached to the distal end portion 108d of the second shaft 108. The nose cone 110 can have a tapered outer surface, as shown for non-invasive tracking of the delivery device 100 through the patient's vasculature. The delivery device 100 further includes a third shaft 104 (the intermediate shaft of the illustrated embodiment) that can extend coaxially over the inner shaft 108 through the outer shaft 102. The cord manifold 106 can be connected to the intermediate shaft 104, such as at its distal end. A plurality of cords, or tethers 118, can be routed through the cord manifold 106 and the frame anchor 80b, as further described below, to hold the frame anchor in the delivery configuration. The proximal end portions of the outer shaft 102, the intermediate shaft 104, and the inner shaft 108 can be coupled to a handle of the delivery device 100 (e.g., the handle 210 discussed below).

[0100] The delivery device 100 is particularly suitable for delivering and implanting a self-expanding artificial valve 50 that radially expands to its functional size under its own elasticity when deployed from the delivery capsule 102d.

[0101] Alternatively, the artificial heart valve 50 can be a plastically expandable artificial valve or a mechanically expandable heart valve. If the delivery device is used to implant a plastically expandable valve, the delivery device can include a balloon catheter known in the art for expanding an artificial valve, as disclosed in U.S. Publication No. 2009 / 0281619, which is incorporated herein by reference. If the delivery device is used to implant a mechanically expandable valve, the delivery device can include one or more actuators for expanding an artificial valve, as disclosed in U.S. Patent Application No. 62 / 945,039, filed December 6, 2019, which is incorporated herein by reference.

[0102] As shown in FIGS. 9A-9B, when the delivery capsule 102d houses the artificial heart valve 50 in a radially compressed state, the delivery device 100 may be connected to the artificial heart valve 50 via a plurality of cords, or tethers 118. For purposes of illustration, the inner surface of the capsule 102d is shown to be slightly spaced from the outer surface of the frame 52b. However, when the artificial valve 50 is loaded into the capsule 102d, the inner surface of the capsule contacts the outer surface of the artificial valve 50, and it should be understood that, as is known in the art, the artificial valve can be held in a radially compressed state.

[0103] In the embodiment of FIGS. 9A-9B, each cord 118 extends distally from a proximal portion (such as the handle 210) of the delivery device 100 within the lumen of the outer shaft 102, through the opening 112 of the cord manifold 106, and the corresponding opening 86 of the frame anchor 80b, and then extends proximally to a proximal portion of the delivery device 100. Each cord 118 can be maintained in tension and / or a taut state such that each frame anchor 80b is maintained in a delivery configuration and the artificial valve 50 is housed within the delivery capsule 102d. The ends of each cord 118 can be exposed at the proximal end of the delivery device or coupled to an actuator of the delivery device that can control the tension of the cord and / or secure the cord to the handle during delivery and placement of the artificial valve.

[0104] The cord 118 may be made of any of a variety of suitable biocompatible materials for use within a patient's body. In certain embodiments, the cord 118 can include a single filament cord, or multifilament cord, or multistrand cord formed by braiding, weaving, knitting, twisting, and winding together a plurality of filaments, or strands. The filaments, or strands, can include polymeric fibers such as ultra-high molecular weight polyethylene, nylon, polyester, and / or aramid, or a flexible wire (e.g., a metal wire).

[0105] The delivery device 100 can include any suitable number of cords 118. For example, the number of cords 118 may be equal to the number of frame anchors 80b of the prosthetic valve 50 (e.g., three) such that each cord 118 extends through the opening 86 of each respective frame anchor 80b. In other embodiments, a single cord 118 can extend through the openings 86 of two or more frame anchors 80b of the prosthetic valve 50.

[0106] In use, the prosthetic valve 50 can be connected to the delivery device 100 and loaded into the delivery capsule 102d as follows. A releasable connection having a separate cord 118 can be formed between the opening 86 of each frame anchor 80b and the cord manifold 106. Optionally, the length of the cord 118 is selected such that the fixed end of the frame is held in a radially compressed state at least partially by the cord. Further, the cord 118 can be configured to apply a restraining force proximal to each frame anchor 80b to maintain each frame anchor 80b in a delivery configuration while the prosthetic valve 50 is loaded within the delivery capsule 102d (e.g., due to its length).

[0107] After fixing the end of the frame 52b with the cord 118, the delivery capsule 102d can advance distally over the cord manifold 106, the cord 118, and the frame 52b, folding the frame into a radially compressed state under the force of the delivery capsule 102d. The delivery capsule 102d advances distally until the distal end of the delivery capsule 102d abuts the nose cone 110 and completely encloses the prosthetic valve 52a / 52b, as shown in FIG. 9A.

[0108] After loading the prosthetic heart valve 50 into the delivery device 100 described above, the delivery device can be inserted into the patient's vasculature and advanced or navigated through the patient's vasculature to a desired implantation site (e.g., when delivering the prosthetic valve 50 to the native aortic valve in a retrograde delivery approach, through the femoral artery and aorta).

[0109] Once the prosthetic valve 50 is delivered to a selected implantation site within the patient (e.g., the native aortic valve), the nose cone 110 can optionally move distally away from the adjacent end of the delivery capsule 102d by pushing the inner shaft 108 distally to avoid contact between the prosthetic valve and the nose cone during valve deployment. The delivery capsule 102d may be housed to deploy the prosthetic valve 50. When the delivery capsule 102d is retracted, as shown in FIG. 9B, the prosthetic valve can radially self-expand under the elasticity of the frame 52b. After the delivery capsule 102d is fully retracted from the prosthetic valve 50, the prosthetic valve remains attached to the delivery device 100 by the cord 118. While remaining attached to the delivery device, the user can operate the delivery device (e.g., by moving it in the proximal and distal directions and / or rotating it) to adjust the position of the prosthetic valve relative to the desired implantation location.

[0110] Optionally, the delivery capsule can advance back over the prosthetic valve 50 to fully or partially recapture the prosthetic valve (return the prosthetic valve into the capsule), facilitating repositioning of the prosthetic valve or retrieval of the prosthetic valve from the patient's body. For example, it may be desirable to cross the native aortic valve leaflets with a retrograde delivery approach, deploy the prosthetic valve, then recapture the prosthetic valve into the capsule, retract the delivery device, return the prosthetic valve into the aorta, and then advance the prosthetic valve across the native aortic valve leaflets and deploy the prosthetic valve from the capsule.

[0111] During the implantation procedure, the prosthetic valve 50 is positioned relative to the native valve annulus such that the inflow end portion 66 is within the native valve annulus and each frame anchor 80b is positioned adjacent to the native commissure. Imaging techniques such as fluoroscopy can be used to position the frame anchors relative to the native commissure and the inflow end portion relative to the native valve annulus. This positioning can be achieved, for example, while the prosthetic valve is still fully contained within the capsule 102d. In other embodiments, the delivery capsule 102d can be partially retracted such that at least the inflow end portion 66 can expand while still retaining the frame anchor 80b and / or the outflow end portion 65 within the delivery capsule 102d as shown in FIG. 9B. The final positioning of the frame anchors 80b can be performed while they are retained within the delivery capsule 102d.

[0112] Once the prosthetic valve 50 is deployed from the delivery capsule 102d and positioned at the desired implantation location, the cords 118 can be released from the frame 52b. In the embodiments of FIGS. 9A - 9B, this can be accomplished by releasing the tension on each cord 118 to release the restraining force applied to the frame anchors 80b and then pulling one end of each cord 118 in the proximal direction, thereby pulling the other end distally through the outer shaft 102, the opening 112, and the opening 86, and then back in the proximal direction through the shaft 102, thereby releasing the cords from the frame 52b.

[0113] Since the cords 118 no longer apply a restraining force to the frame anchors 80b, the frame anchors 80b are free to automatically transition from the delivery configuration to the deployed configuration so as to extend around and / or engage with the native valve leaflets 44 of the patient's heart 40 as shown in FIG. 6.

[0114] The delivery device 100 can be configured to deliver an artificial valve 50 including a frame 52a. For use with the frame 52a, the cord 118 can be routed through the openings 86 in each leg portion 84 of each frame anchor 80a and tensioned to dispose the leg portions 84 of each frame anchor 80a in a delivery configuration. The same cord 118, or separate cords 118, can be routed through two openings in each frame anchor 80a. The artificial valve 50 including the frame 52a can be delivered and implanted in the same manner as described above, except that deploying the frame anchor 80a involves releasing the two leg portions 84 of each frame anchor, thereby enabling the leg portions of each frame anchor to return to a deployed configuration around a pair of native valve leaflets.

[0115] Figures 10A - 10B show another embodiment of a delivery device 200 having an artificial heart valve 50 supported within the delivery device 200. The delivery device 200 of the illustrated embodiment includes a first shaft 202 (the outer shaft of the illustrated embodiment), a second shaft 204 (the intermediate shaft of the illustrated embodiment) extending through the first shaft, and a third shaft 206 (the inner shaft of the illustrated embodiment) extending through the second shaft 204. The delivery device further includes a delivery capsule 240 that houses the artificial heart valve 50 in a radially compressed state, and a nose cone 208 supported on the distal end portion 206d of the third shaft 206. The delivery capsule 240 can be a separate component coupled to and extending from the distal end portion of the first shaft 202, or the distal end of the first shaft 202. The proximal end portions of the shafts 202, 204, and 206 can be connected to a handle 210 having one or more actuators, such as in the form of rotatable knobs 212, 214. The knob 212 can be configured to move the outer shaft 202 and the capsule 240 distally and proximally relative to the artificial valve and the other shafts 204, 206.

[0116] As shown in FIGS. 10A-10B, when the delivery capsule 240 houses the artificial heart valve 50 in a radially compressed state, the delivery device 200 may be connected to the artificial heart valve 50 via a plurality of cords, or tethers 230. The cord 230 may be formed from the same material as described above for the cord 118. For illustrative purposes, the inner surface of the capsule 240 is shown to be slightly spaced from the outer surface of the frame 52b. However, as is known in the art, it should be understood that when the artificial valve 50 is loaded into the capsule 240, the inner surface of the capsule contacts the outer surface of the artificial valve 50 and can hold the artificial valve in a radially compressed state.

[0117] The delivery device 200 further includes a cord manifold 218 coupled to a second shaft 204, and a plurality of release members 226. The cord manifold 218 includes a proximal portion 220 and a distal portion 222. Each release member 226 extends between the proximal portion 220 and the distal portion 222. The proximal portion 220 is supported on the distal end portion of the second shaft 204, while the distal portion 222 is supported on a spacer shaft 224 that extends between the proximal portion 220 and the distal portion 222. The spacer shaft 224 may represent a portion of the second shaft 204 that extends between the proximal portion 220 and the distal portion 222, or the spacer shaft 224 may be a separate component from the second shaft 204. As shown in FIGS. 10A-10B, the second shaft 204 and the spacer shaft 224 may be hollow so as to accommodate a third shaft 206 that extends therethrough.

[0118] Each of the cords 230 has a first end 230a attached to the cord manifold 218, such as the distal portion 222, and a second end 230b releasably held by each release member 226. In this example, each cord 230 extends through the opening 86 of each frame anchor 80b and has a second end 230b in the form of a loop held on the release member 226. Each release member 226 may include and / or be any suitable structure for holding the second end 230b of each cord 230, examples of which include rods, bars, wires, rigid cables, and the like.

[0119] The release member 226 is configured to hold the cord 230 in a state connected to the frame 52b of the artificial valve 50, while the release member 226 extends between the proximal portion 220 and the distal portion 222 of the cord manifold 218. Each release member 226 may extend distally through an opening (not shown) in the proximal portion 220 and an opening (not shown) in the distal portion 222 from the handle 210. The loop 230b is preferably held on the release member 226 at a position between the proximal portion 220 and the distal portion 222. To release the cord 230 from the artificial valve 50, the release member 226 may be retracted proximally to pull the release member out of the distal portion 222 and optionally the proximal portion 220. Retracting the release member 226 pulls them out of the loop 230b so that they are no longer held in place by the release member 226.

[0120] In the embodiment of FIGS. 10A - 10B, three release members 226 are used, each of which holds each cord 230 coupled to each frame anchor 80b. In FIGS. 10A - 10B, only two release members 226 and two cords 230 are visible, and the third release member and the third cord are hidden behind the inner shaft 206 and the spacer shaft 224. However, it should be understood that any number of release members 226 and / or cords 230 can be used.

[0121] Also, there need not be an equal number of codes 230 and release members 226. For example, the ends 230b of a plurality of codes 230 can be held on a single release member. Desirably, at least three codes 230 are used to balance the attachment of the frame 52b to the code manifold 218. In certain embodiments, the number of codes 230 is equal to the number of frame anchors 80b of the frame 52b of the prosthetic valve 50. Further, in other embodiments, a single code can be used to form a plurality of paths extending through the openings of the frame and / or the openings 86 of the frame anchors 80b, to connect the frame 52b to the code manifold 120b at a plurality of locations along the outflow end of the frame.

[0122] Each release member 226 can extend in a slidable manner through the openings of each of the proximal portion 220 and the distal portion 222 of the code manifold 218 and can be actuated to slide through the proximal portion 220 and the distal portion 222 in any suitable manner. For example, each release member 226 may have a proximal end portion operatively coupled to a knob 214 on the handle 210 to control movement of the release member. Each of the release members 226 is movable in a proximal direction and a distal direction with respect to the proximal portion 220 and the distal portion 222 of the code manifold 218 between a distal position where each release member 226 holds each code 230 and a proximal position where each release member 226 is released from each code 230.

[0123] Once the prosthetic valve 50 is delivered to a selected implantation site within the patient (e.g., the native aortic valve), the nose cone 208 can optionally be distally advanced away from the adjacent end of the delivery capsule 240 by advancing the inner shaft 206 distally to avoid contact between the prosthetic valve and the nose cone during valve deployment. The handle 210 may have an additional knob (not shown) for controlling the advancement of the inner shaft 206. The delivery capsule 240 may then be retracted, such as by actuating the knob 212, to deploy the prosthetic valve 50. When the delivery capsule 240 is retracted, as shown in FIG. 10B, the prosthetic valve can radially self-expand under the elasticity of the frame 52b.

[0124] Even after the delivery capsule 240 is fully retracted from the prosthetic valve 50, the prosthetic valve remains attached to the delivery device 200 by the cord 230. When the prosthetic valve 50 is deployed from the delivery capsule 240 and positioned at the desired implantation site, the cord 230 can be released from the frame 52b as described above. The positioning of the valve 50 and the anchor 80b may be performed as described above in connection with FIGS. 9A - 9B.

[0125] The delivery device 200 can be configured to deliver a prosthetic valve 50 comprising a frame 52a. For use with the frame 52a, the cord 230 is routed through the openings 86 of each leg portion 84 of each frame anchor 80a and removably coupled to the release member 226 to position the leg portions 84 of each frame anchor 80a in a delivery configuration. The same cord 230, or a separate cord 230, can be routed through two openings of each frame anchor 80a. The prosthetic valve 50 comprising the frame 52a can be delivered and implanted in the same manner as described above, except that deploying the frame anchor 80a involves releasing the two leg portions 84 of each frame anchor, thereby allowing the leg portions of each frame anchor to return to a deployed configuration around a pair of native valve leaflets.

[0126] Further details regarding the attachment of the prosthetic valve 10 to the delivery devices 100 and 200 via one or more cords or sutures are disclosed in U.S. Publication Nos. 2014 / 0343670, 2012 / 0239142, 2010 / 0049313, and 2022 / 0000619, as well as WIPO Publication No. WO2021 / 195090, all of which are incorporated herein by reference. Delivery techniques

[0127] To implant a prosthetic valve into the native aortic valve via a transfemoral delivery approach, the prosthetic valve is attached in a radially compressed state along the distal end portion of the delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral artery and advanced through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned inside the native aortic valve and expanded radially (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the prosthetic valve from a sheath to make the prosthetic valve self-expanding). Alternatively, the prosthetic valve can be implanted inside the native aortic valve via a transapical procedure, in which case the prosthetic valve (on the distal end portion of the delivery device) 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 inside the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example, by a partial J sternotomy or a small right parasternal thoracotomy, and then advanced through the ascending aorta towards the native aortic valve.

[0128] To implant an artificial valve inside the native mitral valve via a transseptal delivery approach, the artificial valve is mounted in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral vein, into the inferior vena cava, and through the inferior vena cava into the right atrium, across the atrial septum (through a puncture made within the atrial septum), into the left atrium, and advanced toward the native mitral valve. Alternatively, the artificial valve can be implanted inside the native mitral valve via a transapical procedure, whereby the artificial valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and at the apex of the heart, and the artificial valve is positioned inside the native mitral valve.

[0129] To implant an artificial valve inside the native tricuspid valve, the artificial valve is mounted in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral vein, into the inferior vena cava, and through the inferior vena cava advanced into the right atrium, and the artificial valve is positioned inside the native tricuspid valve. A similar approach can be used to implant the artificial valve inside the native pulmonary valve or pulmonary artery, except that the artificial valve advances through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0130] Another delivery approach is the transatrial approach, whereby the artificial valve (on the distal end portion of the delivery device) is inserted through an incision in the chest, and the incision is formed through the atrial wall (the atrial wall of the right atrium or the left atrium) to access any of the native heart valves. Transatrial delivery can also be performed from within a blood vessel, such as from a pulmonary vein, for example. Yet another delivery approach is the transventricular approach, in which case the artificial valve (on the distal end portion of the delivery device) is inserted through an incision in the chest, and the incision is formed through the wall of the right ventricle (typically at or near the base of the heart) to implant the artificial valve inside the native tricuspid valve or inside the native pulmonary valve or inside the pulmonary artery.

[0131] In all delivery approaches, the delivery device can advance through a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any prosthetic valve disclosed herein can be implanted using any of a variety of delivery procedures known in the art and any of a variety of delivery devices.

[0132] Any of the systems, devices, apparatuses, etc. herein can be sterilized (e.g., using heat, radiation, and / or chemicals, etc.) to ensure safety for use in a patient, and any of the methods herein can include sterilization of the associated systems, devices, apparatuses, etc. as one of the method steps. Examples of heat / thermal sterilization include steam sterilization and autoclave sterilization. Examples of radiation for use in sterilization include, but are not limited to, gamma radiation and ultraviolet light. Examples of chemicals for use in sterilization include, but are not limited to, ethylene oxide and hydrogen peroxide. Sterilization with hydrogen peroxide may be performed, for example, using hydrogen peroxide plasma. Additional examples related to the disclosed technology

[0133] In view of the implementations described above with respect to the disclosed subject matter, this application discloses the additional examples listed below. It should be noted that one feature in an example, or two or more features in combination in that example, and optionally in combination with one or more features in one or more additional examples, are also further examples that fall within the disclosure of this application.

[0134] Example 1. An artificial heart valve for implantation within a native heart valve comprising a plurality of native valve leaflets, said artificial heart valve comprising a radially expandable frame having an annular body with an inflow end and an outflow end, said body being radially expandable between a radially compressed state and a radially expanded state, a valve structure comprising a plurality of valve leaflets disposed within and coupled to said frame, said valve structure being configured to regulate one-way blood flow through said frame from said inflow end to said outflow end, said frame comprising a plurality of frame anchors coupled to said body, each frame anchor being configured to be positioned over or around a pair of free ends of two of said native valve leaflets.

[0135] Example 2. The artificial heart valve according to any of the embodiments described herein, particularly the artificial heart valve described in Example 1, wherein said artificial heart valve is configured to be implanted within the aortic valve annulus.

[0136] Example 3. The artificial heart valve according to any of the embodiments described herein, particularly the artificial heart valve described in any one of Examples 1-2, wherein said artificial heart valve is a self-expanding valve configured to self-expand from a radially compressed state to a radially expanded state.

[0137] Example 4. The artificial heart valve according to any of the embodiments described herein, particularly the artificial heart valve described in any one of Examples 1-3, wherein said artificial heart valve is configured to expand from a radially compressed state to a radially expanded state by inflating a balloon of a delivery device.

[0138] Example 5. The artificial heart valve according to any of the embodiments described herein, particularly the artificial heart valve described in any one of Examples 1-4, further comprising an outer skirt at least partially covering an outer surface of said body.

[0139] Example 6. The artificial heart valve according to any one of the embodiments described herein, particularly the artificial heart valve described in Embodiment 5, wherein the outer skirt extends at least partially between each frame anchor and the body.

[0140] Embodiment 7. The artificial heart valve according to any one of the embodiments described herein, particularly any one of Embodiments 1 to 6, wherein the body includes a plurality of circumferentially extending struts that form a plurality of vertices at the inflow end and the outflow end of the frame.

[0141] Embodiment 8. The artificial heart valve according to any one of the embodiments described herein, particularly any one of Embodiments 1 to 7, wherein when the artificial heart valve is in a radially expanded state, the body is at least substantially cylindrical near the outflow end, and the body flares radially outwardly toward the inflow end.

[0142] Embodiment 9. The artificial heart valve according to any one of the embodiments described herein, particularly any one of Embodiments 1 to 8, wherein the body includes an inflow end portion having the inflow end, and the inflow end portion flares radially outwardly.

[0143] Embodiment 10. The artificial heart valve according to any one of the embodiments described herein, particularly any one of Embodiments 1 to 9, wherein the outflow end of the body has a first diameter, the inflow end of the body has a second diameter larger than the first diameter, and the second diameter is larger than the diameter of the annular portion into which the artificial heart valve is implanted.

[0144] Embodiment 11. The artificial heart valve according to any one of the embodiments described herein, particularly any one of Embodiments 1 to 10, wherein each frame anchor is configured to transition from a delivery configuration to a deployed configuration to anchor the artificial heart valve within a native heart valve.

[0145] Embodiment 12. Each frame anchor is configured to bend as the frame anchor transitions between the delivery configuration and the deployment configuration, in any of the embodiments described herein, particularly the artificial heart valve described in Embodiment 11.

[0146] Embodiment 13. Each frame anchor is biased towards the deployment configuration, in any of the embodiments described herein, particularly the artificial heart valve described in any one of Embodiments 11 - 12.

[0147] Embodiment 14. Each frame anchor is configured to automatically transition from the delivery configuration to the deployment configuration when the restraining force is removed from the frame anchor, in any of the embodiments described herein, particularly the artificial heart valve described in any one of Embodiments 11 - 13.

[0148] Embodiment 15. Each frame anchor includes at least one opening configured to engage a cord of a delivery device, each frame anchor is configured to receive a restraining force from the cord, each frame anchor is configured to be maintained in the delivery configuration while the cord applies the restraining force to the frame anchor, and each frame anchor is configured to freely transition from the delivery configuration to the deployment configuration when the cord stops applying the restraining force to the frame anchor, in any of the embodiments described herein, particularly the artificial heart valve described in any one of Embodiments 11 - 14.

[0149] Embodiment 16. Each frame anchor is substantially U - shaped when the frame anchor is in the deployment configuration, in any of the embodiments described herein, particularly the artificial heart valve described in any one of Embodiments 11 - 15.

[0150] Embodiment 17. The artificial heart valve according to any of the embodiments described herein, particularly any one of Embodiments 1 to 16, wherein the frame anchor is configured to engage with the natural valve tip and anchor the artificial heart valve in place with respect to the annulus of the heart including the natural heart valve against retrograde blood flow.

[0151] Embodiment 18. The artificial heart valve according to any of the embodiments described herein, particularly any one of Embodiments 1 to 17, wherein the body includes a plurality of circumferentially extending struts that form a plurality of vertices at the inflow end and the outflow end of the frame, and each frame anchor is coupled to the body at an intersection of the struts between a pair of circumferentially adjacent vertices.

[0152] Embodiment 19. The artificial heart valve according to any of the embodiments described herein, particularly any one of Embodiments 1 to 18, wherein each frame anchor is formed of a plastically deformable material.

[0153] Embodiment 20. The artificial heart valve according to any of the embodiments described herein, particularly any one of Embodiments 1 to 19, wherein each frame anchor is formed of a shape memory material.

[0154] Embodiment 21. The artificial heart valve according to any of the embodiments described herein, particularly any one of Embodiments 1 to 20, wherein each frame anchor is formed of the same material as at least a portion of the body.

[0155] Embodiment 22. The artificial heart valve according to any of the embodiments described herein, particularly any one of Embodiments 1 to 21, wherein each frame anchor is integrally formed with at least a portion of the body.

[0156] Embodiment 23. The artificial heart valve according to any of the embodiments described herein, particularly any one of Embodiments 1 to 21, wherein each frame anchor is formed separately from the body and joined to the body.

[0157] Example 24. An artificial heart valve according to any of the embodiments described herein, particularly any one of Embodiments 1 to 23, wherein each frame anchor is coupled to the body via one or more of welding, an adhesive, a suture thread, and a mechanical connector.

[0158] Example 25. An artificial heart valve according to any of the embodiments described herein, particularly any one of Embodiments 1 to 24, wherein each frame anchor is configured to engage each pair of natural valve leaflets of the natural heart valve proximate to the natural commissures of the natural heart valve when the artificial heart valve is implanted within the natural heart valve.

[0159] Example 26. An artificial heart valve according to any of the embodiments described herein, particularly any one of Embodiments 1 to 25, wherein each frame anchor is configured to be clamped onto each pair of natural valve leaflets of the natural heart valve when the artificial heart valve is implanted within the natural heart valve.

[0160] Example 27. An artificial heart valve according to any of the embodiments described herein, particularly any one of Embodiments 1 to 26, wherein each frame anchor includes an intermediate portion and a pair of leg portions extending away from the intermediate portion.

[0161] Example 28. An artificial heart valve according to any of the embodiments described herein, particularly the artificial heart valve according to any one of Embodiments 27, wherein each leg portion is configured to engage a natural valve leaflet of the natural heart valve proximate to the natural commissure of the natural heart valve when the artificial heart valve is implanted within the natural heart valve.

[0162] Example 29. An artificial heart valve according to any of the embodiments described herein, particularly any one of Embodiments 27 to 28, wherein each leg portion is integrally formed with the intermediate portion.

[0163] Example 30. For each frame anchor, the middle part is fixed at a predetermined position with respect to the main body, and each leg part is configured to pivot with respect to the middle part to shift the frame anchor between a delivery configuration and a deployed configuration, an artificial heart valve according to any embodiment described herein, particularly any one of Embodiments 27 to 29.

[0164] Embodiment 31. For each leg part, an artificial heart valve according to any embodiment described herein, particularly the artificial heart valve described in Embodiment 30, is configured to pivot about an axis perpendicular to a plane extending along a tangent line of the main body to which the frame anchor is attached to the main body.

[0165] Embodiment 32. When the frame anchor is in the delivery configuration, each leg part extends from the middle part toward the outflow end, and when the frame anchor is in the deployed configuration, each leg part extends away from the middle part toward the inflow end, an artificial heart valve according to any embodiment described herein, particularly any one of Embodiments 30 to 31.

[0166] Embodiment 33. When the frame anchor is in the delivery configuration, each leg part extends to the outflow end and continues beyond the outflow end, an artificial heart valve according to any embodiment described herein, particularly the artificial heart valve described in Embodiment 32.

[0167] Embodiment 34. For each leg part, an artificial heart valve according to any embodiment described herein, particularly any one of Embodiments 30 to 33, includes an opening configured to engage with a cord of a delivery device.

[0168] Embodiment 35. When the frame anchor is in the delivery configuration, the frame anchor is substantially U-shaped, an artificial heart valve according to any embodiment described herein, particularly any one of Embodiments 30 to 34.

[0169] Embodiment 36. For each frame anchor, the pair of leg portions includes a first leg portion and a second leg portion, the first leg portion is fixed to the main body at a predetermined position, and one or both of the intermediate portion and the second leg portion pivot relative to the first leg portion to move the frame anchor between a delivery configuration and a deployed configuration. The artificial heart valve according to any one of the embodiments described herein, particularly any one of embodiments 27 to 29.

[0170] Embodiment 37. The artificial heart valve according to any one of the embodiments described herein, particularly the artificial heart valve according to embodiment 36, wherein the intermediate portion is configured to pivot about an axis perpendicular to a plane extending along a tangent to the main body to which the frame anchor is attached.

[0171] Embodiment 38. The artificial heart valve according to any one of the embodiments described herein, particularly any one of embodiments 36 to 37, wherein when the frame anchor is in the delivery configuration, the second leg portion extends from the first leg portion toward the outflow end, and when the frame anchor is in the deployed configuration, the second leg portion extends away from the first leg portion toward the inflow end.

[0172] Embodiment 39. The artificial heart valve according to any one of the embodiments described herein, particularly the artificial heart valve according to embodiment 38, wherein when the frame anchor is in the delivery configuration, the second leg portion extends to the outflow end and continues beyond the outflow end.

[0173] Embodiment 40. The artificial heart valve according to any one of the embodiments described herein, particularly any one of embodiments 36 to 39, wherein the second leg portion is not connected to the main body.

[0174] Embodiment 41. The artificial heart valve according to any one of the embodiments described herein, particularly any one of embodiments 36 to 40, wherein the second leg portion is provided with an opening configured to engage with the code of the delivery device.

[0175] Example 42. The artificial heart valve according to any one of the embodiments described herein, particularly any one of embodiments 36 to 41, wherein the first leg portion and the second leg portion are substantially in a straight line when the frame anchor is in the delivery configuration.

[0176] Example 43. An artificial heart valve for implantation within a native heart valve including a plurality of native valve leaflets, the artificial heart valve comprising a radially expandable frame having an annular body with an inflow end and an outflow end, the body being radially expandable between a radially compressed state and a radially expanded state, a frame; a valve structure disposed within and coupled to the frame and comprising a plurality of valve leaflets configured to regulate a one-way blood flow through the frame from the inflow end to the outflow end, the frame comprising a plurality of frame anchors coupled to the body, each frame anchor comprising a first leg portion, a second leg portion, and an intermediate portion, each of the first leg portion and the second leg portion extending away from the intermediate portion, each frame anchor being configured to bend with respect to the body for transitioning between a delivery configuration and a deployed configuration, and for each frame anchor, when the frame anchor is in the deployed configuration and when the artificial heart valve is implanted within the native heart valve, the first leg portion extending along a first valve leaflet of the plurality of native valve leaflets, the second leg portion extending along a second valve leaflet of the plurality of native valve leaflets, and the intermediate portion being positioned adjacent to a free end of each of the first valve leaflet and the second valve leaflet.

[0177] Example 44. For any of the embodiments described herein, particularly the artificial heart valve described in Embodiment 43, each frame anchor is substantially U-shaped when the frame anchor is in the deployed configuration.

[0178] Embodiment 45. For any of the embodiments described herein, particularly the artificial heart valve described in any one of Embodiments 43 to 44, for each frame anchor, the first leg portion and the second leg portion extend at least substantially parallel to each other when the frame anchor is in the delivery configuration and when the frame anchor is in the deployed configuration.

[0179] Embodiment 46. For any of the embodiments described herein, particularly the artificial heart valve described in any one of Embodiments 43 to 45, for the frame anchor, when the frame anchor is in the deployed configuration and when the artificial heart valve is implanted within the native heart valve, the first leg portion presses against the first valve leaflet and the second leg portion presses against the second valve leaflet.

[0180] Embodiment 47. For any of the embodiments described herein, particularly the artificial heart valve described in any one of Embodiments 43 to 46, each frame anchor is substantially U-shaped when the frame anchor is in the delivery configuration.

[0181] Embodiment 48. For any of the embodiments described herein, particularly the artificial heart valve described in any one of Embodiments 43 to 47, for each frame anchor, the first leg portion and the second leg portion are substantially collinear when the frame anchor is in the delivery configuration.

[0182] Embodiment 49. For each frame anchor, any of the embodiments described herein, particularly the artificial heart valve according to any one of Embodiments 43 to 48, wherein one or both of the first leg portion and the second leg portion are provided with an opening configured to engage with the cord of the delivery device.

[0183] Embodiment 50. For each frame anchor, any of the embodiments described herein, particularly the artificial heart valve according to any one of Embodiments 43 to 49, wherein the intermediate portion is fixedly coupled to the main body.

[0184] Embodiment 51. For each frame anchor, any of the embodiments described herein, particularly the artificial heart valve according to any one of Embodiments 43 to 50, wherein the first leg portion is fixedly coupled to the main body.

[0185] Embodiment 52. For each frame anchor, any of the embodiments described herein, particularly the artificial heart valve according to any one of Embodiments 1 to 51, wherein the frame anchor is at least partially covered by a protective cover.

[0186] Embodiment 53. An artificial heart valve delivery assembly, comprising an artificial heart valve for implantation within a native heart valve including a plurality of native valve leaflets, the artificial heart valve comprising a radially expandable frame having an annular body with an inflow end and an outflow end, the body being radially expandable between a radially compressed state and a radially expanded state; a valve structure disposed within and coupled to the frame, the valve structure configured to regulate a one-way blood flow through the frame from the inflow end to the outflow end; the frame comprising a plurality of frame anchors coupled to the body, each frame anchor configured to be positioned over or around a pair of free ends of two of the native valve leaflets; and a delivery device for delivering the artificial heart valve to an implantation site, the delivery device comprising a delivery capsule configured to receive the artificial heart valve in a radially compressed state, and a plurality of cords, each removably connected to a respective frame anchor of the artificial heart valve and configured to apply a restraining force to the respective frame anchor.

[0187] Example 54. For each cord and each frame anchor, the artificial heart valve delivery assembly of any of the embodiments described herein, particularly embodiment 53, wherein the frame anchor comprises an opening and the cord extends through the opening when the artificial heart valve is received within the delivery capsule.

[0188] Example 55. Each frame anchor is configured to transition from a delivery configuration to a deployed configuration to anchor the artificial heart valve within the natural heart valve. For each cord and each frame anchor, the cord is configured to maintain the frame anchor in the delivery configuration while the cord applies the restraining force to the frame anchor, and the frame anchor automatically transitions from the delivery configuration to the deployed configuration when the cord ceases to apply the restraining force to the frame anchor. The artificial heart valve delivery assembly according to any of the embodiments described herein, particularly any one of embodiments 53-54.

[0189] Example 56. The artificial heart valve delivery assembly according to any of the embodiments described herein, particularly any one of embodiments 53-55, wherein the cord is configured to maintain at least partially in a radially compressed state the end portion of the frame including the frame anchor when the cord is connected to the frame anchor and applies a restraining force to the frame anchor.

[0190] Example 57. The artificial heart valve delivery assembly according to any of the embodiments described herein, particularly any one of embodiments 53-56, further comprising a handle portion, a first shaft extending between the handle portion and the delivery capsule, an inner shaft configured to extend through the artificial heart valve when the artificial heart valve is housed within the delivery capsule, and a nose cone mounted on the distal end portion of the distal inner shaft of the delivery capsule.

[0191] Example 58. A cord manifold including a proximal portion and distal portions axially spaced from each other, and a plurality of release members extending from the handle portion, through the first shaft, through the proximal portion, and at least partially through the distal portion, each cord having a first end attached to the proximal portion and a second end held on each release member between the proximal portion and the distal portion, the delivery device being configured to withdraw the release members from one or both of the distal portion and the proximal portion, such that the second end of the cord is no longer held in place by the release member, in any of the embodiments described herein, particularly the artificial heart valve delivery assembly described in Embodiment 57.

[0192] Embodiment 59. Any of the embodiments described herein, particularly the artificial heart valve delivery assembly described in Embodiment 58, wherein each release member is coupled to a knob on the handle portion and includes a proximal end portion that controls movement of the release member.

[0193] Embodiment 60. Any of the embodiments described herein, particularly the artificial heart valve delivery assembly described in any one of Embodiments 58 - 59, wherein each release member is movable in a proximal direction and a distal direction with respect to the proximal portion and the distal portion of the cord manifold between a distal position where each release member holds each cord and a proximal position where each release member is released from each cord.

[0194] Embodiment 61. Any of the embodiments described herein, particularly the artificial heart valve delivery assembly described in any one of Embodiments 58 - 60, wherein each second end includes a loop extending around each release member.

[0195] Embodiment 62. Any of the embodiments described herein, particularly the artificial heart valve delivery assembly described in any one of Embodiments 58 - 61, wherein each release member includes one or more of a rod, bar, wire, and cable.

[0196] Example 63. Any of the embodiments described herein, particularly the artificial heart valve delivery assembly according to any one of embodiments 57 to 62, wherein the delivery device is configured to advance the nose cone distally from an adjacent end of the delivery capsule by advancing the inner shaft distally of the handle portion and / or to retract the delivery capsule proximally toward the handle portion, so that the artificial heart valve can be released from the delivery capsule.

[0197] Example 64. The artificial heart valve is a sterilized artificial heart valve according to any of the embodiments described herein, particularly any one of embodiments 1 to 52.

[0198] Example 65. The delivery device and the artificial heart valve are a sterilized artificial heart valve delivery assembly according to any of the embodiments described herein, particularly any one of embodiments 53 to 63.

[0199] Example 66. A method comprising sterilizing an artificial heart valve or an artificial heart valve delivery assembly according to any of the embodiments described herein, particularly any one of embodiments 1 to 65.

[0200] Unless otherwise specified, the features described herein for any embodiment may be combined with any one or more of the other features described in any one or more of the other embodiments. For example, any one or more of the features of one artificial heart valve can be combined with any one or more of the features of another artificial heart valve. As another example, any one or more of the features of one artificial heart valve delivery assembly can be combined with any one or more of the features of another artificial heart valve delivery assembly.

[0201] Considering the many possible ways in which the principles of the present disclosure may be applied, it should be recognized that the illustrated configurations are examples of the disclosed technology and should not be construed as limiting the scope of the present disclosure or the scope of the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

Claim 1 An artificial heart valve for implantation within a native heart valve including a plurality of native valve leaflets, the artificial heart valve comprising: A radially expandable frame having an annular body with an inflow end and an outflow end, the body being radially expandable between a radially compressed state and a radially expanded state; a frame; A valve structure disposed within and coupled to the frame, the valve structure including a plurality of leaflets configured to regulate one-way blood flow through the frame from the inflow end to the outflow end; a valve structure; The frame comprising a plurality of frame anchors coupled to the body; An artificial heart valve, wherein each frame anchor is configured to be positioned over or around a pair of free ends of two of the native valve leaflets. Claim 2 The artificial heart valve of claim 1, wherein the frame anchors are configured to engage the native valve leaflets to anchor the artificial heart valve in a predetermined position relative to the annulus of the native heart valve against retrograde blood flow. Claim 3 The artificial heart valve of claim 1 or 2, further comprising an outer skirt at least partially covering the outer surface of the body, the outer skirt at least partially extending between each frame anchor and the body. Claim 4 The artificial heart valve of any one of claims 1 to 3, wherein the body comprises an inflow end portion having the inflow end, the inflow end portion flaring radially outwardly. Claim 5 The artificial heart valve of any one of claims 1 to 4, wherein each frame anchor is configured to transition from a delivery configuration to a deployed configuration to anchor the artificial heart valve within the native heart valve, and each frame anchor is biased toward the deployed configuration. Claim 6 The artificial heart valve of claim 5, wherein each frame anchor is configured to bend as the frame anchor transitions between the delivery configuration and the deployed configuration. Claim 7 Each frame anchor includes at least one opening configured to engage with the code of the delivery device, each frame anchor is configured to receive a restraining force from the code, each frame anchor is configured to be maintained in the delivery configuration while the code applies the restraining force to the frame anchor, and each frame anchor is configured to freely transition from the delivery configuration to the deployment configuration when the code no longer applies the restraining force to the frame anchor. The artificial heart valve according to any one of claims 5 to 7.

8. The artificial heart valve according to any one of claims 5 to 7, wherein each frame anchor is substantially U-shaped when the frame anchor is in one or both of the deployment configuration and the delivery configuration.

9. The artificial heart valve according to any one of claims 1 to 8, wherein when the artificial heart valve is implanted into the natural heart valve, each frame anchor is configured to engage with each pair of natural valve leaflets of the natural heart valve proximate to the natural commissures of the natural heart valve.

10. Each frame anchor includes an intermediate portion and a pair of leg portions extending away from the intermediate portion. The artificial heart valve according to any one of claims 1 to 9, wherein when the artificial heart valve is implanted into the natural heart valve, each leg portion is configured to engage with a natural valve leaflet of the natural heart valve proximate to the natural commissure of the natural heart valve.

11. For each frame anchor, the intermediate portion is fixed at a predetermined position relative to the body, and each leg portion is configured to pivot relative to the intermediate portion to transition the frame anchor between a delivery configuration and a deployment configuration. The artificial heart valve according to claim 10.

12. When the frame anchor is in the delivery configuration, each leg portion extends away from the intermediate portion toward the outflow end. When the frame anchor is in the deployment configuration, each leg portion extends away from the intermediate portion toward the inflow end. The artificial heart valve according to claim 11.

13. For each frame anchor, the pair of leg portions includes a first leg portion and a second leg portion, the first leg portion is fixed to the body at a predetermined position, and one or both of the intermediate portion and the second leg portion pivot relative to the first leg portion to configure the frame anchor to transition between a delivery configuration and a deployment configuration. The artificial heart valve according to claim 10.

14. The artificial heart valve according to claim 13, wherein the second leg portion includes an opening configured to engage a cord of a delivery device.

15. An artificial heart valve for implantation within a native heart valve including a plurality of native valve leaflets, the artificial heart valve comprising: A radially expandable frame having an annular body with an inflow end and an outflow end, the body being radially expandable between a radially compressed state and a radially expanded state; a frame; A valve structure disposed within and coupled to the frame, the valve structure including a plurality of valve leaflets configured to regulate a one-way blood flow through the frame from the inflow end to the outflow end; a valve structure; The frame includes a plurality of frame anchors coupled to the body, each frame anchor including a first leg portion, a second leg portion, and an intermediate portion, each of the first leg portion and the second leg portion extending away from the intermediate portion; Each frame anchor is configured to bend relative to the body to transition between a delivery configuration and a deployment configuration. For each frame anchor, when the frame anchor is in the deployment configuration and when the artificial heart valve is implanted within the native heart valve, the first leg portion extends along a first valve leaflet of the plurality of native valve leaflets, the second leg portion extends along a second valve leaflet of the plurality of native valve leaflets, and the intermediate portion is positioned adjacent to free ends of each of the first valve leaflet and the second valve leaflet. An artificial heart valve.

16. The artificial heart valve according to claim 15, wherein each frame anchor is substantially U-shaped when the frame anchor is in one or both of the deployment configuration and the delivery configuration.

17. For each frame anchor, when the frame anchor is in the deployed configuration and when the artificial heart valve is implanted within the native heart valve, the first leg portion is pressed against the first valve leaflet and the second leg portion is pressed against the second valve leaflet, the artificial heart valve according to any one of claims 15 - 16.

18. For each frame anchor, one or both of the first leg portion and the second leg portion comprises an aperture configured to engage a cord of a delivery device, the artificial heart valve according to any one of claims 15 - 17.

19. An artificial heart valve delivery assembly, ・ An artificial heart valve for implantation within a native heart valve including a plurality of native valve leaflets, the artificial heart valve comprising - A radially expandable frame having an annular body with an inflow end and an outflow end, the body being radially expandable between a radially compressed state and a radially expanded state, the frame; - A valve structure disposed within and coupled to the frame, the valve structure including a plurality of valve leaflets configured to regulate a one - way blood flow through the frame from the inflow end to the outflow end, The frame includes a plurality of frame anchors coupled to the body, each frame anchor being configured to be positioned over or around a pair of free ends of two of the native valve leaflets, the artificial heart valve; ・ A delivery device for delivering the artificial heart valve to an implantation site, the delivery device comprising - A delivery capsule configured to receive the artificial heart valve in a radially compressed state; - A plurality of cords, each removably connected to a respective frame anchor of the artificial heart valve and configured to apply a restraining force to the respective frame anchor, An artificial heart valve delivery assembly comprising.

20. For each cord and for each respective frame anchor, the frame anchor includes an aperture and the cord extends through the aperture when the artificial heart valve is received within the delivery capsule, the artificial heart valve delivery assembly according to claim 19.

21. Each frame anchor is configured to transition from a delivery configuration to a deployed configuration to anchor the artificial heart valve within the natural heart valve, and for each cord and each of the frame anchors, the cord is configured to maintain the frame anchor in the delivery configuration while the cord applies the restraining force to the frame anchor, and the frame anchor is configured to automatically transition from the delivery configuration to the deployed configuration when the cord ceases to apply the restraining force to the frame anchor. The artificial heart valve delivery assembly according to any one of claims 19 to 20.

22. The cord is configured to maintain at least partially in a radially compressed state an end portion of the frame including the frame anchor when the cord is connected to the frame anchor and applies the restraining force to the frame anchor. The artificial heart valve delivery assembly according to any one of claims 19 to 21.

23. The delivery device includes a handle portion, a first shaft extending between the handle portion and the delivery capsule, an inner shaft configured to extend through the artificial heart valve when the artificial heart valve is housed within the delivery capsule, a nose cone attached to a distal end portion of the inner shaft distal to the delivery capsule, a cord manifold including a proximal portion and a distal portion axially spaced apart from each other, and further includes a plurality of release members extending from the handle portion, through the first shaft, through the proximal portion, and at least partially through the distal portion. Each cord includes a first end attached to the proximal portion and a second end held on each of the release members between the proximal portion and the distal portion. The delivery device is configured to withdraw the release member from one or both of the distal portion and the proximal portion such that the second end of the cord is no longer held in place by the release member. The artificial heart valve delivery assembly according to any one of claims 19 to 22.

24. The artificial heart valve delivery assembly according to claim 23, wherein each release member is movable in a proximal direction and a distal direction with respect to the proximal portion and the distal portion of the cord manifold between a distal position in which each release member holds its respective cord and a proximal position in which each release member is released from its respective cord.

25. The artificial heart valve delivery assembly according to any one of claims 23 to 24, wherein each release member comprises one or more of a rod, a bar, a wire, and a cable.

26. The delivery device, wherein the artificial heart valve is advancing the nose cone distally from an adjacent end of the delivery capsule by advancing the inner shaft distally of the handle portion; and retracting the delivery capsule proximally toward the handle portion; The artificial heart valve delivery assembly according to any one of claims 23 to 25, configured to be releasable from the delivery capsule by one or both of the above.

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