Prosthetic heart valve and prosthetic heart valve delivery assembly

Abstract

The utility model relates to a prosthetic heart valve and a prosthetic heart valve delivery assembly. In some examples, a prosthetic 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 leaflets disposed within and coupled to a frame. The frame includes a plurality of frame anchors coupled to the body. Each frame anchor is configured to be positioned on or around a pair of free edges of two of the native leaflets of the native heart valve. In some examples, a prosthetic heart valve delivery assembly includes a prosthetic heart valve and a delivery device for delivering the prosthetic heart valve to an implantation site.

Description

[0001] This application is a divisional application. The application date of the original application is July 21, 2023, the application number is 2023219242543, and the name of the invention is "Prosthetic heart valve and prosthetic heart valve delivery assembly".

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 369,170, filed on July 22, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0004] The present disclosure relates to examples of prosthetic valves (eg, prosthetic heart valves) and delivery devices for implanting prosthetic valves. Background Art

[0005] The human heart may suffer from a variety of valvular diseases. These valvular diseases may cause significant dysfunction of the heart and ultimately require repair of the natural valve or replacement of the natural valve with an artificial valve. There are many known repair devices (e.g., stents) and artificial valves, as well as many known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various procedures to deliver prosthetic medical devices to locations in the body that are not easily accessible by surgery or to locations that are desired to be accessible without surgery.

[0006] In one embodiment, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) until the prosthetic heart valve reaches an implantation site in the heart. The prosthetic heart valve can then be expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery device so that the prosthetic heart valve can self-expand to its functional size.

[0007] Because the catheter balloon can exert sufficient expansion force to anchor the prosthetic valve frame to the surrounding calcified tissue, balloon-expandable prosthetic valves are generally preferred for replacing calcified native valves. On the other hand, self-expanding prosthetic valves are sometimes preferred for replacing defective, non-stenotic (non-calcified) native valves, such as inadequate native valves, but they can also be used to replace stenotic valves.

[0008] 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 exert sufficient force on the surrounding tissue to resist migration 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 help anchor the prosthetic valve within the descending aorta. Unfortunately, if future intervention is required, the upper portion of the frame may obstruct access to the coronary ostia. In addition, if the prosthetic valve needs to be removed from the patient, portions of the frame may be fixed to non-diseased areas of the aorta, which may complicate removal of the prosthetic valve. Alternatively, the frame may have additional anchoring devices that may be difficult to position and deploy. Utility Model Content

[0009] Prosthetic heart valves, delivery devices, and methods for implanting prosthetic heart valves are described herein. The disclosed prosthetic heart valves, delivery devices, and methods can, for example, provide various features for maintaining the position and / or orientation of the prosthetic heart valve relative to the heart's native annulus. Thus, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery devices.

[0010] A prosthetic heart valve may include a frame, and a valve structure coupled to the frame.In addition to these components, a prosthetic heart valve may also include one or more of the components disclosed herein.

[0011] In some examples, a prosthetic heart valve can include a radially expandable frame comprising an annular body having an inflow end and an outflow end, and the body is radially expandable between a radially compressed state and a radially expanded state.

[0012] In some examples, the frame can include a plurality of frame anchors coupled to the body.

[0013] In some examples, the prosthetic heart valve can be configured for implantation within a native heart valve comprising a plurality of native leaflets, and each frame anchor can be configured to be positioned on or around a pair of free edges of two of the native leaflets.

[0014] In some examples, the frame anchors can be configured to engage native leaflets to anchor the prosthetic heart valve in place relative to the annulus of the native heart valve to prevent retrograde blood flow.

[0015] In some examples, the body may include an inflow end portion including an inflow end, and the inflow end portion may flare radially outward.

[0016] In some examples, each frame anchor can be configured to transition from a delivery configuration to a deployed configuration to anchor the prosthetic heart valve within a native heart valve, and each frame anchor can be biased toward the deployed configuration.

[0017] In some examples, each frame anchor is substantially U-shaped when the frame anchor is in one or both of the deployed configuration and the delivery configuration.

[0018] In some instances, each frame anchor can include a middle portion and a pair of leg portions extending away from the middle portion, and the prosthetic heart valve can be configured such that each leg portion engages the natural leaflets of the natural heart valve proximate the natural commissures of the natural heart valve when the prosthetic heart valve is implanted within the natural heart valve.

[0019] In some examples, 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 aperture configured to engage a tether of a delivery apparatus.

[0020] In some instances, a prosthetic heart valve for implantation within a natural heart valve comprising a plurality of leaflets comprises a radially expandable frame, and a valve structure comprising a plurality of 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 the flow of blood in one direction from the inflow end through the frame to the outflow end. The frame comprises a plurality of frame anchors coupled to the body. Each frame anchor is configured to be positioned on or around a pair of free edges of two of the natural leaflets.

[0021] In some examples, a prosthetic heart valve for implantation within a native heart valve comprising a plurality of leaflets includes a radially expandable frame and a valve structure comprising a plurality of leaflets disposed within the frame and coupled to the frame. 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 from the inflow end through the frame 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 a middle portion. Each of the first leg portion and the second leg portion extends away from the middle portion. Each frame anchor is configured to flex relative to the body to 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 prosthetic heart valve is implanted within the native heart valve, the first leg portion extends adjacent to a first leaflet of the plurality of native leaflets, the second leg portion extends adjacent to a second leaflet of the plurality of native leaflets, and the middle portion is positioned adjacent to a free edge of each of the first leaflet and the second leaflet.

[0022] In some examples, a prosthetic heart valve includes one or more of the components described in Examples 1-52 below.

[0023] A prosthetic heart valve delivery assembly may include a handle and one or more shafts coupled to the handle.In addition to these components, a prosthetic heart valve delivery assembly may include one or more of the components disclosed herein.

[0024] In some examples, a prosthetic heart valve delivery assembly can include a prosthetic heart valve for implantation within a native heart valve including a plurality of native leaflets, and a delivery device for delivering the prosthetic heart valve to the implantation site.

[0025] In some examples, a prosthetic heart valve can include a radially expandable frame, and a valve structure including a plurality of leaflets disposed within and coupled to the frame.

[0026] In some examples, the frame can include an annular body having an inflow end and an outflow end.

[0027] In some examples, the valve structure can be configured to regulate the flow of blood in one direction from the inflow end through the frame to the outflow end.

[0028] In some examples, the frame can include a plurality of frame anchors coupled to the body.

[0029] In some examples, each frame anchor can be configured to be positioned on or around a pair of free edges of two of the native leaflets.

[0030] In some examples, a delivery device can include a delivery balloon configured to house a prosthetic heart valve in a radially compressed state, and a plurality of tethers.

[0031] In some examples, each of the plurality of cords can be configured to releasably connect to a respective frame anchor of a prosthetic heart valve and apply a restraining force to the respective frame anchor.

[0032] In some examples, for each tether and corresponding frame anchor, the frame anchor can include an aperture, and the tether can extend through the aperture when the prosthetic heart valve is received within the delivery balloon.

[0033] In some examples, each frame anchor can be configured to transition from a delivery configuration to a deployed configuration to anchor the prosthetic heart valve within a native heart valve.

[0034] In some instances, for each tether and corresponding frame anchor, the tether may be configured to maintain the frame anchor in a delivery configuration while the tether applies a restraining force to the frame anchor, and the frame anchor may automatically transition from the delivery configuration to the deployed configuration when the tether no longer applies a restraining force to the frame anchor.

[0035] In some examples, a prosthetic heart valve delivery assembly includes a prosthetic heart valve for implantation within a native valve comprising a plurality of native leaflets, and a delivery device for delivering the prosthetic heart valve to the implantation site. The prosthetic 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 leaflets disposed within and coupled to the frame, and is configured to regulate blood flow in one direction from the inflow end through the frame to the outflow end. The frame includes a plurality of frame anchors coupled to the body. Each frame anchor is configured to be positioned on or around a pair of free edges of two of the native leaflets. The delivery device includes a delivery bag configured to accommodate the prosthetic heart valve in a radially compressed state, and a plurality of tethers. Each tether is configured to releasably connect to a corresponding frame anchor of the prosthetic heart valve and to apply a restraining force to the corresponding frame anchor.

[0036] In some examples, a prosthetic heart valve delivery assembly includes one or more of the components described in Examples 53-63 below.

[0037] The various innovations disclosed herein may be used in combination or individually. This summary is provided to introduce some concepts in a simplified form, which are further described in the detailed description below. This summary is not intended to define the principal or basic structure of the subject matter protected by the claims, nor is it intended to limit the scope of the subject matter protected by the claims. The foregoing and other objects, features, and advantages of the present invention will become more apparent from the detailed description below, which is presented with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] 1 is a perspective view of a prosthetic valve that can be used to replace a natural valve in the heart.

[0039] Figure 2 is a perspective view of another prosthetic valve that can be used to replace a natural valve of the heart, according to one example.

[0040] Figure 3 yes Figure 2 Perspective view of the frame of a prosthetic valve.

[0041] Figure 4 yes Figure 2 Top view of the frame of the prosthetic valve.

[0042] Figure 5 is a cross-sectional view of the heart showing the implantation of the Figure 2 prosthetic valve.

[0043] Figure 6 It is along Figure 5 Line 6-6 observes the implanted heart within the aortic valve annulus Figure 2 Top view of a prosthetic valve.

[0044] Figure 7A Is in extended delivery state Figure 2 Side view of the frame of a prosthetic valve.

[0045] Figure 7B is in delivery configuration Figure 7A An enlarged side view of the frame anchors of the frame.

[0046] Figure 7C Is in deployed configuration Figure 7B An enlarged side view of the frame anchor.

[0047] Figure 8A is a side view of a frame of a prosthetic valve in an expanded delivery state according to another example.

[0048] Figure 8B is in delivery configuration Figure 8A An enlarged side view of the frame anchors of the frame.

[0049] Figure 8C Is in deployed configuration Figure 8B An enlarged side view of the frame anchor.

[0050] Figure 9A Based on an example Figure 8A A side view of a frame of a delivery device shown in a compressed state within a delivery capsule of a delivery device.

[0051] Figure 9B yes Figure 9A Side view of a delivery device with the delivery balloon partially retracted.

[0052] Figure 10A Based on another example Figure 8A A side view of a frame of a delivery device shown in a compressed state within a delivery capsule of a delivery device.

[0053] Figure 10B yes Figure 10A Side view of a delivery device with the delivery balloon partially retracted.

[0054] Figure 11 is a side view of a frame anchor in a deployed configuration and covered by a protective cover. DETAILED DESCRIPTION

[0055] General considerations

[0056] For the purposes of this specification, certain aspects, advantages, and novel features of examples of the present disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and subcombinations with one another. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed examples require the presence of any one or more specific advantages or problems solved.

[0057] Although the operations of some disclosed examples are described in a particular sequential order for ease of presentation, it should be understood that this description includes rearrangement unless the specific language set forth below requires a particular order. For example, the operations described in sequence may in some cases be rearranged or performed simultaneously. In addition, for the sake of simplicity, the accompanying drawings may not illustrate the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, this specification sometimes uses terms such as "provide" or "implement" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are easily discernible by those of ordinary skill in the art.

[0058] As used in this application and the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "including" means "comprising." Furthermore, the term "coupled" generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or connected, and, in the absence of specific language to the contrary, does not preclude the presence of intervening elements between the coupled or associated items.

[0059] As used herein, the term "proximal" refers to a position, direction or part of a device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to a position, direction or part of a device that is further away from the user and further away from the implantation site. Thus, for example, the proximal motion of a device is the motion of the device away from the implantation site and toward the user (e.g., leaving the patient's body), while the distal motion of the device is the motion of the device away from the user and toward the implantation site (e.g., entering the patient's body). The terms "longitudinal" and "axial" refer to the axis extending in the proximal and distal directions, unless otherwise clearly defined.

[0060] As used herein, the term "substantially" refers to the recited values ​​and / or properties, as well as any values ​​and / or properties that are at least 75% of the recited values ​​and / or properties. Equivalently, the term "substantially" refers to the recited values ​​and / or properties, as well as any values ​​and / or properties that vary from the recited values ​​and / or properties by at most 25%. For example, "at least substantially parallel" refers to completely parallel directions, as well as directions that deviate by up to 22.5 degrees.

[0061] As used herein, "such as" means "for example," and "ie" means "that is to say."

[0062] Examples of Disclosed Technology

[0063] Examples of implantable, expandable medical devices (e.g., prosthetic heart valves) are described herein. The prosthetic heart valve is configured to be implanted in the native annulus of a patient's heart. To maintain the position and / or orientation of the prosthetic heart valve relative to the native annulus, the prosthetic heart valve includes a plurality of frame anchors configured to engage the flared inflow end of the native annulus and to engage the native leaflets of the native valve adjacent to the commissures of the native leaflets. The prosthetic heart valve is particularly suitable for implantation within the native aortic or pulmonary valve. However, the prosthetic heart valve may also be suitable for implantation in the other native valves of the heart (mitral and tricuspid valves).

[0064] The prosthetic valves disclosed herein can be radially compressed and expanded between a radially compressed state and a radially expanded state. Thus, during delivery, the prosthetic valve can be crimped on or held by an implant delivery device in a radially compressed state and then expanded to a radially expanded state once the prosthetic valve reaches the implantation site. It should be understood that the prosthetic valves disclosed herein can be used with a variety of implant delivery devices and can be implanted via various delivery procedures, examples of which will be discussed in greater detail later.

[0065] Figure 1 shows an exemplary prosthetic valve 10 according to one example. Any of the prosthetic valves disclosed herein is suitable for implantation in the native aortic valve annulus, but in other examples, the prosthetic valve may be suitable for implantation in other native valve annuli of the heart (pulmonary valve, mitral valve, and tricuspid valve). The disclosed prosthetic valves may also be implanted in a blood vessel connected to the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), or the superior vena cava or inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, and blood vessels of the patient. The disclosed prosthetic valves may also be implanted in a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve) during a valve-in-valve procedure.

[0066] In some examples, the disclosed prosthetic valves can be implanted in a docking or anchoring device implanted within a natural heart valve or blood vessel. For example, in one example, the disclosed prosthetic valves can be implanted in a docking device implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted in a docking device implanted within or at the natural mitral valve, such as disclosed in PCT Publication No. Wo2020 / 247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted in a docking device implanted within the superior or inferior vena cava to replace the function of a diseased tricuspid valve, such as disclosed in U.S. Patent Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0067] As discussed above, FIG1 shows a prosthetic heart valve 10, which is an example of a prosthetic heart valve known in the art, and FIG2 shows a prosthetic heart valve 10, which is an example of a prosthetic heart valve known in the art. Figure 2-4 Aspects of a prosthetic heart valve 50 according to the present disclosure are shown. In some examples, a prosthetic heart valve (e.g., prosthetic heart valve 10 and / or prosthetic heart valve 50) is a self-expanding valve that is delivered to a deployment site in a radially compressed state via a delivery device. When advanced from a delivery balloon at the distal end of the delivery device (as described below with reference to Figures 9A-10BDiscussed), the prosthetic valve can radially self-expand to its functional size.

[0068] 1 , a prosthetic heart valve 10 includes a stent or frame 12 and a valve structure 14 (e.g., a leaflet or flap valve) supported by the frame. The frame 12 may have a plurality of interconnected and circumferentially extending struts 16 arranged in a grid-like pattern and forming a plurality of vertices 18 at an inflow end 20 and an outflow end 22 of the frame 12, respectively. The valve structure 14 is configured to regulate the flow of blood through the prosthetic heart valve 10 from the inflow end 20 to the outflow end 22.

[0069] The frame 12 may include a plurality of angularly spaced posts 24 extending from respective vertices 18 at the outflow end of the frame 12. The frame 12 in the illustrated example includes three such posts 24, but a greater or lesser number of posts may be used. In one embodiment, the frame 12 may have posts extending from all of the vertices 18 at the outflow end of the frame. As further described below, each post 24 may have an eyelet or orifice 26 that may be used to form a releasable connection with a delivery device, such as by using one or more ropes or tethers 118 (see FIG. Figures 9A-9B ).

[0070] In other examples, where other delivery device configurations, such as transapical delivery methods or other delivery techniques, require an orifice at the inlet end of the frame, the orifice 26 may be formed at the inlet (or inflow) end 20 of the frame 12 .

[0071] The framework 12 can be made of any of various suitable plastic expansion materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol) known in the art. When constructed from plastic expansion materials, the framework 12 (and therefore the prosthetic heart valve 10) can be curled into a radially compressed state on a delivery catheter, and then expanded in the patient's body by an inflatable balloon or equivalent expansion mechanism. When constructed from self-expandable materials, the framework 12 (and therefore the prosthetic heart valve 10) can be curled into a radially compressed state, and be limited in a compressed state by inserting a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic heart valve can be advanced from the delivery sheath, which allows the prosthetic heart valve to expand to its functional size.

[0072] Suitable plastically expandable materials that can be used to form the frames disclosed herein (e.g., frame 12) include metal alloys, polymers, or combinations thereof. Example metal alloys can include one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some instances, the frame 12 can comprise stainless steel. In some instances, the frame 12 can comprise a cobalt-chromium alloy. In some instances, the frame 12 can comprise a nickel-cobalt-chromium alloy. In some instances, the frame 12 can comprise a nickel-cobalt-chromium-molybdenum alloy, such as MP35N. TM (Trade name of SPS Technologies), which is equivalent to UNSR30035 (covered by ASTM F562-02). MP35N TM / UNSR30035 contains by weight 35% nickel, 35% cobalt, 20% chromium and 10% molybdenum.

[0073] In a particular example, the prosthetic heart valve 10 is a self-expanding heart valve in which the frame 12 is made of a superelastic, self-expanding material known in the art (e.g., a nickel-titanium alloy such as Nitinol). 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 when advanced from a delivery capsule (e.g., a delivery sheath) of the delivery device. In particular, FIG. 1 illustrates the prosthetic valve 10 in an expanded state.

[0074] The valve structure 14 may include a plurality of leaflets 28. The valve structure typically includes three leaflets 28 arranged in a tricuspid arrangement, but a greater or fewer number of leaflets 28 may be used. The leaflets 28 may 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 side portions at the outflow edges (upper edges in the figures) of adjacent leaflets may be secured to each other to form commissures 30 of the valve structure, which may be secured to the frame with sutures 32.

[0075] The prosthetic valve 10 may also include an inner skirt 34 mounted on the inside of the frame 12. The skirt 34 helps to establish a seal with the surrounding tissue after implantation. The skirt 34 can also be used to mount portions of the leaflets 28 to the frame 12. For example, in the example shown, the inflow edge of the leaflet (the lower edge in the figure) can be sutured to the skirt 34 along sutures 36. The skirt 34 can be directly connected to the frame 12, for example, with sutures. Although not shown, the prosthetic valve 10 may include an outer skirt mounted on the outside of the frame in place of or in addition to the inner skirt 34 to further seal the prosthetic valve against the surrounding tissue.

[0076] Inner skirt and / or outer skirt can be formed wholly or in part by any suitable biomaterial, synthetic material (for example, any one of various polymers) or its combination.In some instances, inner skirt and / or outer skirt can comprise the fabric with interwoven yarn or fiber of the form of for example weaving, braiding or knitting fabric.In some instances, fabric can have plush pile or suede.Exemplary fabric with plush pile or suede comprises velvet, velvet, velveteen, corduroy, terry cloth, fleece etc.In some instances, inner skirt and / or outer skirt can comprise the fabric without interwoven yarn or fiber or randomly interwoven yarn or fiber, for example felt or electrospun fabric.Exemplary materials that can be used to form such fabric (with or without interwoven yarn or fiber) include but are not limited to polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the inner and / or outer skirt can comprise a non-woven or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (e.g., thermoplastic polyurethane (TPU)), etc. In some examples, the inner and / or outer skirt can comprise a sponge material or foam, such as polyurethane foam. In some examples, the inner and / or outer skirt can comprise natural tissue, such as pericardium (e.g., bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0077] Exemplary configurations of prosthetic heart valves are further disclosed in WIPO Publication No. Wo2021 / 195090 and U.S. Patent Application Publication Nos. 2014 / 0343670, 2012 / 0123529, 2010 / 0036484, and 2010 / 0049313, the disclosures of which are incorporated herein by reference.

[0078] Figure 2 A prosthetic heart valve 50 according to the present disclosure is shown, and Figure 3-4 A stent or frame 52a of a prosthetic heart valve 50 is shown. In particular, Figure 2-4 The prosthetic heart valve 50 and / or frame 52a are shown 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 prosthetic heart valve 50 and / or frame 52a.

[0079] Unless otherwise noted, prosthetic heart valve 50 and / or frame 52a can share any suitable components, properties, features, etc. with prosthetic heart valve 10 of FIG. 1 . For example, and as Figure 2-4As shown in , frame 52a may include a base frame structure or body 53 including a plurality of circumferentially extending struts 56, apex 58, inflow end 60, and outflow end 62, each of which may share any characteristics with struts 16, apex 18, inflow end 20, and / or outflow end 22 of frame 12. Similarly, and as shown in Figure 2-4 As shown in FIG, prosthetic heart valve 50 may include a valve structure 54 including a plurality of leaflets 68 forming a plurality of commissures 70, which may share any characteristics with valve structure 14, leaflets 28, and commissures 30, respectively, of prosthetic heart valve 10. Leaflets 68 may be assembled to frame 52a in the same manner as leaflets 28 of prosthetic valve 10. For example, the cusp edges of leaflets 68 may be sutured to inner skirt 34 along suture lines. Figure 2 1 ). Additionally, the commissures of leaflets 68 can be connected to frame 52a, for example, by suturing the commissure tabs of the leaflets to struts of the frame in the manner shown in FIG1 . However, it should be understood that the leaflets 68 can be assembled to the frame using any known technique or mechanism known in the art.

[0080] In addition, if Figure 2 As shown in , the prosthetic heart valve 50 may include an outer skirt 78 mounted on the exterior of the body 53 of the frame, which may share any applicable features and / or characteristics with the inner skirt 34 of the prosthetic heart valve 10. In particular, the outer skirt 78 may be secured to the exterior of the body 53, for example, with sutures. When present, the outer skirt 78 may be configured to seal the prosthetic heart valve 50 against surrounding tissue. Figure 2 As shown in FIG, the outer skirt 78 can cover the main body 53 (which is thus Figure 2 The outer skirt 78 may cover all or at least substantially all of the outer surface of the body 53 (hidden in the drawing). In other examples, the outer skirt 78 may cover only a portion of the outer surface of the 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 annulus.

[0081] like Figure 3 As shown in FIG, the frame 52a has a body 53 including an inflow end portion or region 66, an outflow end portion or region 65, and a waist portion or region 64 extending between the inflow end portion and the outflow end portion. At least when the frame 52a is in the expanded state, the outflow end portion 65 is generally cylindrical, while the inflow end portion 66 is flared outward. In particular, and as shown in FIG. Figure 3As shown in FIG, when the frame 52a is in the 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 greater than D1.

[0082] As more specific examples, D2 can 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 at most 225% of D1, at most 180% of D1, at most 160% of D1, at most 140% of D1 and / or at most 120% of D1.

[0083] In a specific example, for a prosthetic valve intended for use in a 22 mm to 24 mm annulus, diameter D2 is about 28 millimeters (mm) to about 32 mm, with 30 mm being a specific example, and diameter D1 is about 24 mm to about 28 mm, with 26 mm being a specific example. In a specific example, the prosthetic valve has a length, as measured between inflow end 60 and outflow end 62, of about 20 mm to about 24 mm, with 22 mm being a specific example.

[0084] In some instances, such as Figure 3 In the example of the embodiment of the present invention, 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 gradually increase (e.g., monotonically increase) from the diameter D1 at the outflow end 62 to the diameter D2 at the inflow end 60.

[0085] 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 outwardly so that the diameter of the outflow end portion 65 increases in a direction extending from the waist region 64 to the outflow end 62. In other 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.

[0086] The increased diameter of the inflow end 60 can help anchor the prosthetic heart valve 50 in the annulus of a native valve (e.g., a native aortic valve) once implanted in the heart. In particular, D2 is desirably greater than the diameter of the native annulus in which the prosthetic heart valve 50 will be implanted. In this way, the overall shape of the frame 52a helps retain the prosthetic heart valve 50 at the implantation site.

[0087] More specifically, Figure 5-6A prosthetic heart valve 50 is shown implanted within the aortic annulus 42 of the aorta 41 of the heart 40 such that the flared inflow end 60 extends below the aortic annulus 42. The prosthetic heart valve 50 is retained within the native valve at least in part by the radially outward force of the prosthetic heart valve 50 against the surrounding tissue of the aortic annulus 42 and the geometry of the frame 52a. Specifically, the flared inflow end region 66 is shaped to conform to the aortic annulus 42 and can extend to a subvalvular position to better resist axial displacement of the prosthetic heart valve 50 primarily in the upstream direction (toward the aorta). In some instances, the inflow end 60 of the frame can be located in the left ventricle when the prosthetic valve 50 is implanted. In some instances, the radially outward force of the inflow end region 66 against the native annulus can also help to retain the prosthetic valve to prevent axial displacement in the downstream direction (toward the left ventricle). In addition, as Figure 5 As shown in , the prosthetic heart valve 50 can form a substantially fluid-tight seal with the aortic valve annulus 42 via contact between the aortic valve annulus 42 and the flared inflow end region 66 of the frame 52a (and / or the outer skirt 78 therein) to prevent or minimize paravalvular leakage.

[0088] The frame 52a of the prosthetic heart valve 50 may additionally include specialized features and / or structures for anchoring the prosthetic heart valve 50 relative to the native aortic annulus 42. In particular, and as Figure 2-4 , the frame 52a of the prosthetic heart valve 50 includes a plurality of frame anchors 80a coupled to the body 53 at locations axially spaced from the inflow end of the frame. The frame anchors 80a are configured to engage the native leaflets 44 of the aortic valve at or near the native commissures 45 to help hold the prosthetic heart valve 50 in place relative to the aortic annulus 42 to prevent retrograde blood flow.

[0089] The number of frame anchors 80a desirably corresponds to the number of native commissures 45 of the native valve in which the prosthetic valve will be implanted. For most patients, the native aortic, tricuspid, and pulmonary valves have three native commissures. Thus, for implantation at the native aortic, tricuspid, or pulmonary valves, the frame may have three frame anchors 80a corresponding to the three native commissures. For implantation at a bicuspid native aortic valve or a native mitral valve, the frame may have two frame anchors 80a.

[0090] In other instances, the frame 52a may have fewer frame anchors 80a than the number of native commissures of the native valve in which the prosthetic valve will be implanted, such as 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.

[0091] In yet other examples, the frame 52 may have more frame anchors 80a than the number of natural commissures of the native valve in which the prosthetic valve will be implanted. This configuration can facilitate positioning a corresponding frame anchor 80a at each native commissure in the native valve, where the natural commissures are unevenly spaced from one another in the circumferential direction. 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 positioned circumferentially between two primary frame anchors. If it is determined that one or more primary anchors are not aligned with the natural commissures, the frame can be positioned so that one or more of the secondary anchors are aligned with these natural commissures.

[0092] In the example shown, Figure 2 and 6 , each frame anchor 80a is located on the body of the frame at a position circumferentially aligned with the commissures 70 of the prosthetic valve. Thus, when the prosthetic valve 50 is implanted within the native aortic valve, each frame anchor 80a is located at the native commissures 45, and each commissure 70 of the prosthetic valve is rotationally aligned with one of the native commissures 45. In this position, each commissure 70 of the prosthetic valve 50 is rotationally offset from the coronary ostia 47. In this manner, the frame anchor 80a acts as a positioning / alignment member to rotationally align the prosthetic valve relative to the coronary ostia.

[0093] Positioning the commissures at a position rotationally offset from the coronary ostia 47 has several potential benefits. For example, the commissures of a prosthetic valve positioned in front of the coronary ostia can obstruct or interfere with catheterization of the coronary arteries during a subsequent procedure. However, positioning the commissures 70 of the prosthetic valve at a position rotationally offset from the coronary ostia 47 can facilitate access to the coronary arteries, for example, to perform a subsequent coronary angiography or angioplasty procedure. In addition, if a replacement prosthetic valve is implanted in a previously implanted prosthesis 50 (in a "valve-in-valve" procedure), it may be desirable to modify the leaflets 68 of the previously implanted valve, for example by cutting the leaflets 68 or forming openings in the leaflets 68 at a location between the commissures, to increase access to the coronary arteries. When the previously implanted prosthetic valve is in this orientation, a physician can more easily access the leaflets 68 using a medical device to modify the leaflets.

[0094] In other examples, the frame anchors 80a may be positioned on the body of the frame at locations that are circumferentially offset from the commissures 70 .

[0095] Once the prosthetic valve 50 is implanted, the position of the native leaflets 44 relative to the frame 52a and / or frame anchors 80a can vary depending on the patient's anatomy and / or the condition of the native leaflets 44. Figure 6Each native leaflet 44 is shown contacting the outer surface and / or outer skirt 78 of the frame 52a, which may be the case for stenotic (calcified) native leaflets 44.

[0096] However, in other examples, each native leaflet 44 can extend relative to the frame anchor 80a and / or relative to the frame 52a in any of a variety of ways depending on the patient's anatomy and the condition of the native leaflets. For example, each native leaflet 44 can extend between adjacent frame anchors 80a such that each native leaflet 44 is radially spaced apart from the outer surface of the frame anchor 80a and from the outer surface of the frame 52a, at least in a region proximal to the outflow end 62, which may be the case for non-stenotic (non-calcified) native leaflets 44.

[0097] Each frame anchor 80a may be attached to the body 53 of the frame 52a at any of a variety of locations (e.g., anywhere along the waist portion 64 or outflow end portion 65). Figure 3 and Figures 7A-7C In the example of , each frame anchor 80a is attached to the body 53 at the intersection of four struts 56 at locations spaced apart from each of the inflow end 60 and the outflow end 62. Specifically, Figure 3 and Figures 7A-7C In the example shown, each frame anchor 80a is attached to the body 53 at a location spaced apart from the outflow end 62 by a row of struts 56. In other examples, 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., at the outflow apex 58), or may be attached to a single strut 56.

[0098] In some instances, and as Figure 3 and 7A As shown in FIG, the frame anchors 80a can be evenly distributed around the circumference of the body 53. In particular, Figure 3 and 7A In the example shown, the body 53 includes twelve 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 it is within the scope of the present disclosure that the frame anchors 80a may be unevenly distributed around the circumference of the body 53.

[0099] Each frame anchor 80a can be coupled to the body 53 in any suitable manner. In some examples, each frame anchor 80a is formed from 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 piece of nitinol). In other examples, each frame anchor 80a and the body 53 can be formed separately, and the frame anchor can be subsequently joined to the body 53. The frame anchor 80a can be connected to the body 53 using various techniques and mechanisms, 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 connecting devices.

[0100] exist Figure 2 In the example of FIG, 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 a hole, cutout, opening, aperture, etc. at the location where each frame anchor 80a is attached to the body 53.

[0101] In some instances, and as Figure 11 As shown in , each frame anchor 80a can be at least partially covered or substantially covered (e.g., wrapped) by a protective covering 94 that protects the natural leaflets from direct contact with the frame anchor 80a. In such instances, the protective covering 94 can minimize or prevent trauma to the patient's natural tissue by avoiding direct contact between the metal anchors and the tissue. When present, the protective covering 94 can include and / or be any of a variety of materials, examples of which include any of a variety of synthetic materials or natural tissues. For example, the covering can be in the form of a fabric (e.g., a PET fabric or a fabric formed from other types of synthetic fibers) or a non-fabric material, such as a layer of polymeric material (e.g., a thermoplastic polyurethane (TPU) layer) or a foam or sponge (e.g., a polyurethane foam or hydrogel foam) layer. Additionally or alternatively, the protective covering 94 can be formed of the same material as the inner skirt and / or outer skirt of the prosthetic valve 10. However, not all instances require this, and it is within the scope of the present disclosure for each frame anchor 80a to be uncovered.

[0102] exist Figure 2-4In the example shown, each frame anchor 80a includes a middle portion 82 and a pair of leg portions 84 extending away from the middle portion 82. Thus, each frame anchor 80a in the example shown is U-shaped or substantially U-shaped, but in other examples, the anchors can have various other shapes, such as a V-shape. In the example shown, the middle portion 82 can be fixed relative to the frame and, therefore, can be referred to as a fixed portion of the frame anchor 80a. The leg portions 84 can be fixed in the delivery configuration ( Figure 7A and 7B ) and deployment configuration ( Figure 3 and Figure 7C ) between (e.g., pivoting).

[0103] like Figure 7A and 7B As shown in FIG, in the delivery configuration, each leg portion 84 extends away from the middle portion 82 in a downstream direction toward the outflow end 62 of the frame. In some examples, when each frame anchor 80a is in the delivery configuration, each leg portion 84 can extend from the middle portion 82 toward the outflow end 62 and continue beyond the outflow end 62 of the frame. Figure 3 and 7C As shown in FIG, in the deployed configuration, each leg portion 84 extends away from the middle portion 82 toward the inflow end 60 of the frame.

[0104] Figures 7B-7C The detailed view of FIG shows that each frame anchor 80a can be moved from the delivery configuration ( Figure 7B ) to the deployed configuration ( Figure 7C ) method. Specifically, in Figures 7B-7C In an example, each leg portion 84 pivots relative to the middle 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 can be configured to pivot about an axis that is perpendicular to a plane extending tangentially to the body 53 to which the frame anchor 80a is attached. In such an example, each leg portion 84 can be integrally formed with the middle portion 82 such that the leg portion 84 can bend or deform when transitioning from the delivery configuration to the deployed configuration.

[0105] In some instances, the frame anchor 80a can be formed of a shape memory material such as nitinol. When formed of a shape memory material, the anchor 80a can set its shape in the deployed configuration. Thus, when the prosthetic valve 50 is loaded onto a delivery device for delivery into the patient's body, the frame anchor 80a can be deformed into the delivery configuration and retained 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 implant site, the anchor member can automatically return to the deployed configuration under its own elasticity.

[0106] like Figure 2-3 and Figures 7A-7C As shown in , each leg portion 84 may include an eyelet or orifice 86 configured to engage a tether of a delivery device to selectively maintain the leg portion 84 in a delivery configuration to resist the inherent spring force that biases the leg portion to the deployment configuration. When the prosthetic valve is loaded onto the delivery device, the tether can be arranged through the orifice 86 of each leg portion and pulled in the proximal direction to bend the leg portion 84 to the delivery configuration. During delivery through the patient's vascular system, the tether can remain taut to maintain the leg portion in the delivery configuration. When the main body 53 of the frame is deployed (or alternatively, before or after the main body 53 is deployed), the tension on the tether can be released to allow the leg portion 84 to return to the deployment 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.

[0107] In other instances, the frame anchor 80a can be formed from a plastically deformable material (e.g., stainless steel, cobalt-chromium alloy), in which case the frame anchor 80a can be plastically deformed from a delivery configuration to a deployed configuration at or near the implantation site, for example, by actuating components of a delivery device.

[0108] In the deployed configuration, each frame anchor 80a is configured to be placed around the free edge of a pair of native leaflets at or proximate to the native commissures. As discussed above, Figure 5-6 An example of a prosthetic heart valve 50 implanted within the native aortic valve annulus 42 of a heart 40 is shown. Figure 5-6 In the example of FIG, each frame anchor 80a is in a deployed configuration and is positioned around the free edges of a pair of native leaflets 44 at the native commissures 45. Thus, when the prosthetic heart valve 50 is implanted in the aortic annulus 42, for each frame anchor 80a, the middle portion 82 is positioned adjacent to or against the free edges of the pair of leaflets 44, one of the leg portions 84 extends beside one of the leaflets 44, and the other leg portion 84 extends beside the other leaflet at the same native commissures 45. In this way, the frame anchor 80a can help retain the prosthetic valve within the native aortic valve by resisting migration of the prosthetic valve in an upstream direction (toward the left ventricle) to prevent retrograde blood flow.

[0109] In some instances, the leg portions 84 can be configured to clamp onto a pair of natural leaflets or to clamp a pair of leaflets between the leg portions. In other words, the lateral spacing between the leg portions 84 can be sized so that when the frame anchor is placed around a pair of leaflets, the leg portions 84 apply a clamping force against the adjacent surfaces of the leaflets. In this way, the leg portions 84 engage and frictionally engage the leaflets between the leg portions by the clamping force applied by the leg portions against the leaflets. If the frame anchor is formed of a shape memory material, the leg portions 84 can be configured to clamp onto a pair of leaflets as they transition from a delivery configuration to a deployed configuration. If the frame anchor is formed of a plastically deformable material, the leg portions 84 can be pressed against the adjacent surfaces of the leaflets as they transition from the delivery configuration to the deployed configuration. When configured to engage the adjacent surfaces of a pair of leaflets, the leg portions 84 can be referred to as the leaflet engagement portions of the frame anchor 80a.

[0110] exist Figure 2-7C In the example, each frame anchor 80a and / or its leg portion 84 is positioned adjacent to (eg, proximate to and / or in contact with) the body 53 when the frame anchors 80a are in the deployed configuration.

[0111] In other examples, at least a portion of each frame anchor 80a (e.g., its leg portions 84) can be spaced apart from the body 53 when the frame anchor 80a is in the deployed configuration. In particular, such a configuration can facilitate positioning the prosthetic heart valve 50 relative to the aortic annulus 42 such that each frame anchor 80a can engage a corresponding pair of native leaflets 44 with minimal obstruction by the body 53. In some such examples, each leg portion 84 can be coupled to the body 53 via a spacing member that spaces at least a portion of the frame anchor 80a away from the body 53. For example, the spacing member can extend between the middle portion 82 and the body 53, or the frame anchor 80a (and / or its middle portion 82) can include a spacing member. In some examples, each spacing member can include and / or can be a spacing strut that extends between the body 53 and the middle portion 82.

[0112] Figures 8A-8C A frame 52b for a prosthetic heart valve 50 according to another example is shown. The frame 52b includes a body 53 (described above) and a plurality of frame anchors 80b coupled to the body. The frame 52b can share any suitable components, features, configurations, etc. with the frame 52a, such as the body 53. The soft components (e.g., leaflets, inner skirt, and / or outer skirt) of the prosthetic valve 50 are located in the Figures 8A-8C are not shown for illustration purposes, but they can be combined with the above Figure 2 In certain examples, frame 52b is identical to frame 52a except for the differences between frame anchors 80b and frame anchors 80a, which are described below.

[0113] Each frame anchor 80b can 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 at one of the leg portions 84 rather than at the middle portion 82. Figures 8A-8C In the example of , the leg portion 84 includes a first leg portion 84 a connected to the main body 53 (which may be referred to as a fixed portion of the frame anchor 80 b ) and a second leg portion 84 b not connected to the main body 53 .

[0114] Figures 8A-8B Each frame anchor 80b is shown in a delivery configuration, while Figure 8C Frame anchors 80b are shown in a deployed configuration. In the delivery configuration, each frame anchor 80b can be straight or substantially straight and can extend in a downstream direction from the location where the first leg portion 84a is connected to the body 53. In particular, and as shown Figure 8B As shown in FIG, when the frame anchor 80b is in the delivery configuration, the first leg portion 84a and the second leg portion 84b can be substantially co-linear.

[0115] like Figures 8B-8C , each frame anchor 80b is configured to transition from a delivery configuration to a deployed configuration via pivoting and / or bending of the middle portion 82 and / or the second leg portion 84b relative to the first leg portion 84a in the direction indicated by arrow 92. More specifically, the middle portion 82 and / or the second leg portion 84b can be configured to pivot about an axis that is perpendicular to a plane extending tangentially to the 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, with the ends of the two leg portions 84a, 84b pointing toward the inflow end 60 of the body 53.

[0116] As discussed above with respect to frame anchor 80a, frame anchor 80b may be made of a shape memory material, wherein frame anchor 80b may be Figure 8A and 8B , the frame anchors 80b are shaped in the delivery configuration shown in FIG. As further described below, the frame anchors 80b can be retained in the delivery configuration by a retaining element of a delivery device, such as a tether. Each frame anchor 80b can include an aperture 86 in the leg portion 84b to receive a retaining element of a delivery device. Alternatively, the anchors 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.

[0117] As discussed above, prosthetic heart valve 50 may be delivered through the patient's vasculature to an implantation site via a delivery device. Figures 9A-9B The distal portion of an example of a delivery device 100 is shown, wherein the prosthetic heart valve 50 is supported within the delivery device 100. However, it should be understood that the delivery device 100 can also be used to support and / or deliver any other prosthetic heart valve according to the present disclosure. Furthermore, it is within the scope of the present disclosure that any prosthetic heart valve disclosed herein can be delivered to an implantation site via any suitable delivery device, including delivery devices not specifically disclosed herein.

[0118] exist Figures 9A-9B In the example of FIG, the delivery device 100 includes a first shaft 102 (an outer sheath or outer shaft 102 in the example shown), a distal portion of which forms a delivery capsule 102d that contains the prosthetic 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, Figures 9A-9B The prosthetic heart valve 50 is shown as a frame 52b; however, it should be understood that the prosthetic heart valve 50 housed within the delivery capsule 102d will also include components such as Figure 2 Components of the outer skirt 78 and valve structure 54 are shown in FIG.

[0119] exist Figures 9A-9B In the example shown, the delivery device 100 also includes a second shaft 108 (inner shaft 108 in the example shown) that extends through the prosthetic heart valve 50 and supports a nose cone 110 of the delivery device 100. Specifically, the nose cone 110 can be connected to the distal portion 108d of the second shaft 108 or mounted on the distal portion of the second shaft. The nose cone 110 can have a tapered outer surface as shown in the figure for atraumatic tracking of the delivery device 100 through the patient's vascular system. The delivery device 100 also includes a third shaft 104 (an intermediate shaft in the example shown) that can pass through the outer shaft 102 and extend coaxially above the inner shaft 108. A tether manifold 106 can be connected to the intermediate shaft 104, for example, at the distal end of the intermediate shaft. As further described below, a plurality of tethers or tethers 118 can be arranged through the tether manifold 106 and the frame anchor 80b to maintain 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 (eg, handle 210 discussed below).

[0120] The delivery apparatus 100 is particularly well-suited for delivering and implanting a self-expandable prosthetic valve 50 that radially expands to its functional size under its own elasticity when deployed from the delivery capsule 102d.

[0121] Alternatively, the prosthetic heart valve 50 can be a plastically expandable prosthetic valve or a mechanically expandable heart valve. If the delivery device is used to implant a plastically expandable valve, the delivery device may include a balloon catheter known in the art for expanding a prosthetic valve, such 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 may include one or more actuators for expanding the prosthetic valve, such as disclosed in U.S. Application No. 62 / 945,039, filed December 6, 2019, which is incorporated herein by reference.

[0122] like Figures 9A-9B As shown in FIG, when delivery capsule 102d contains prosthetic heart valve 50 in a radially compressed state, delivery device 100 can be connected to prosthetic heart valve 50 via a plurality of cords or tethers 118. For illustrative purposes, the inner surface of capsule 102d is shown slightly spaced apart from the outer surface of frame 52b. However, it should be understood that, as is known in the art, when prosthetic valve 50 is loaded into capsule 102d, the inner surface of the capsule can contact the outer surface of prosthetic valve 50 and maintain the prosthetic valve in the radially compressed state.

[0123] exist Figures 9A-9B In the example of FIG. 1 , each tether 118 extends distally from a proximal portion of the delivery device 100 (e.g., handle 210) within the lumen of the outer shaft 102, passes through the aperture 112 in the tether manifold 106 and the aperture 86 of the corresponding frame anchor 80b, and then returns proximally to the proximal portion of the delivery device 100. Each tether 118 can be maintained in a tensioned and / or taut state such that each frame anchor 80b remains in the delivery configuration while the prosthetic valve 50 is contained within the delivery sac 102d. The end of each tether 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 tether and / or secure the tether relative to the handle during delivery and placement of the prosthetic valve.

[0124] The cord 118 can be made of any of a variety of suitable biocompatible materials for use in patients. In some instances, the cord 118 can include a monofilament cord, or a multifilament or multi-strand cord formed by braiding, weaving, knitting, twisting, and winding a plurality of filaments or strands together. The filaments or strands can include polymeric fibers such as ultra-high molecular weight polyethylene, nylon, polyester, and / or aromatic or flexible wires (e.g., metal wire).

[0125] The delivery device 100 can include any suitable number of tethers 118. For example, the number of tethers 118 can be equal to the number of frame anchors 80b of the prosthetic valve 50 (e.g., three), such that each tether 118 extends through the aperture 86 of a corresponding frame anchor 80b. In other examples, a single tether 118 can extend through the apertures 86 of two or more frame anchors 80b of the prosthetic valve 50.

[0126] In use, the prosthetic valve 50 can be connected to the delivery device 100 and loaded into the delivery pouch 102d as follows. A releasable connection can be formed between the orifice 86 of each frame anchor 80b and the tether manifold 106 using a separate tether 118. Optionally, the length of the tether 118 is selected so that the fixed end of the frame is held in at least a partially radially compressed state by the tether. Additionally, the tether 118 can be configured (e.g., due to its length) to exert a proximally directed restraining force on each frame anchor 80b to maintain each frame anchor 80b in the delivery configuration when the prosthetic valve 50 is loaded into the delivery pouch 102d.

[0127] After securing the ends of the frame 52b with the tethers 118, the delivery balloon 102d can be advanced distally over the tether manifold 106, the tethers 118, and the frame 52b, causing the frame to collapse to a radially compressed state under the force of the delivery balloon 102d. Figure 9A As shown in FIG, delivery balloon 102d is advanced distally until the distal end of delivery balloon 102d abuts nose cone 110 to completely surround prosthetic valve 52a / 52b.

[0128] As described above, after the prosthetic heart valve 50 is loaded within the delivery device 100, the delivery device can be inserted into the patient's vasculature and advanced or navigated through the patient's vasculature to the desired implantation site (e.g., through the femoral artery and aorta to the native aortic valve when delivering the prosthetic valve 50 in a retrograde delivery manner).

[0129] Once the prosthetic valve 50 is delivered to the selected implantation site in the patient (e.g., the native aortic valve), the nose cone 110 can optionally be advanced distally away from the adjacent end of the delivery sac 102d by pushing the inner shaft 108 distally to avoid contact between the prosthetic valve and the nose cone during valve deployment. The delivery sac 102d can be retracted to deploy the prosthetic valve 50. When the delivery sac 102d is retracted, and as shown in FIG. Figure 9BAs shown in FIG, 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 tether 118. While still attached to the delivery device, the user can manipulate the delivery device (e.g., by moving the delivery device in the proximal and distal directions and / or rotating the delivery device) to adjust the position of the prosthetic valve relative to the desired implantation location.

[0130] If desired, the delivery balloon can be advanced back over the prosthetic valve 50 to fully or partially recapture the prosthetic valve (bring the prosthetic valve back into the balloon) to facilitate repositioning the prosthetic valve or removing the prosthetic valve from the patient's body. For example, after deploying the prosthetic valve across the native aortic valve leaflets in a retrograde delivery manner, it may be desirable to recapture the prosthetic valve back into the balloon, retract the delivery device to bring the prosthetic valve back into the aorta, and then advance the prosthetic valve back across the native aortic valve leaflets and deploy the prosthetic valve from the balloon.

[0131] During the implantation procedure, the prosthetic valve 50 is positioned relative to the native annulus such that the inflow end portion 66 is within the native annulus and each frame anchor 80b is positioned adjacent to the native commissures. Imaging techniques such as fluoroscopy can be used to position the frame anchors relative to the native commissures and the inflow end portion relative to the native annulus. For example, this positioning can be accomplished while the prosthetic valve is still fully contained within the sac 102d. In other examples, such as Figure 9B , delivery balloon 102d can be partially retracted to allow at least inflow end portion 66 to expand while still retaining frame anchors 80b and / or outflow end portion 65 within delivery balloon 102d. Final positioning of frame anchors 80b can be performed while they remain within delivery balloon 102d.

[0132] Once the prosthetic valve 50 is deployed from the delivery capsule 102d and positioned at the desired implantation location, the tether 118 can be released from the frame 52b. Figures 9A-9B In the example of , this can be accomplished by releasing the tension in each tether 118 to release the restraining force applied to the frame anchor 80b, and then pulling one end of each tether 118 in a proximal direction, which causes the other end to be pulled distally through the outer shaft 102, the aperture 112, the aperture 86, and then back in a proximal direction through the shaft 102, thereby releasing the tether from the frame 52b.

[0133] like Figure 6 As depicted in , because the tether 118 no longer applies a restraining force to the frame anchor 80b, the frame anchor 80b is free to automatically transition from the delivery configuration to the deployed configuration so as to extend around and / or engage with the native leaflets 44 of the patient's heart 40.

[0134] The delivery device 100 can be configured to deliver a prosthetic valve 50 including a frame 52a. For use with the frame 52a, a tether 118 can be routed through the aperture 86 of each leg portion 84 of each frame anchor 80a and tensioned to place the leg portion 84 of each frame anchor 80a in the delivery configuration. The same tether 118 or separate tethers 118 can be routed through both apertures of each frame anchor 80a. The prosthetic valve 50 including the frame 52a can be delivered and implanted in the same manner as described above, except that deploying the frame anchors 80a requires releasing both leg portions 84 of each frame anchor, which allows the leg portions of each frame anchor to return to the deployed configuration around a pair of native leaflets.

[0135] Figures 10A-10B Another example of a delivery device 200 is shown, in which a prosthetic heart valve 50 is supported within the delivery device 200. The delivery device 200 in the illustrated example includes a first shaft 202 (which is the outer shaft in the illustrated example), a second shaft 204 (which is the middle shaft in the illustrated example) extending through the first shaft, and a third shaft 206 (which is the inner shaft in the illustrated example) extending through the second shaft 204. The delivery device also includes a delivery capsule 240 that contains the prosthetic heart valve 50 in a radially compressed state, and a nose cone 208 supported on the distal portion 206d of the third shaft 206. The delivery capsule 240 can be the distal portion of the first shaft 202, or a separate component coupled to and extending from the distal end of the first shaft 202. The proximal portions of the shafts 202, 204, and 206 can be connected to a handle 210, which can have one or more actuators, for example, in the form of rotatable knobs 212, 214. The knob 212 can be configured to move the outer shaft 202 and balloon 240 distally and proximally relative to the prosthetic valve and the other shafts 204 , 206 .

[0136] like Figures 10A-10B , when delivery capsule 240 contains prosthetic heart valve 50 in a radially compressed state, delivery device 200 can be connected to prosthetic heart valve 50 via a plurality of tethers or tethers 230. Tethers 230 can be formed of the same material as described above for tethers 118. For illustrative purposes, the inner surface of capsule 240 is shown as being slightly spaced apart from the outer surface of frame 52b. However, it should be understood that, as is known in the art, when prosthetic valve 50 is loaded into capsule 240, the inner surface of the capsule can contact the outer surface of prosthetic valve 50 and maintain the prosthetic valve in the radially compressed state.

[0137] The delivery device 200 also includes a tether manifold 218 coupled to the second shaft 204, and a plurality of release members 226. The tether 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 a distal 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 can 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 can be a separate component from the second shaft 204. Figures 10A-10B As shown in FIG, the second shaft 204 and the spacing shaft 224 may be hollow to accommodate the third shaft 206 extending therethrough.

[0138] Each of the cords 230 has a first end 230a attached to the cord manifold 218 (e.g., distal portion 222), and a second end 230b releasably retained by a corresponding release member 226. In this example, each cord 230 extends through the aperture 86 of the corresponding frame anchor 80b and has a second end 230b in the form of a loop retained on the release member 226. Each release member 226 may include and / or be any suitable structure for retaining the second end 230b of each cord 230, examples of which include a rod, a bar, a wire, a rigid cable, etc.

[0139] Release members 226 are configured to maintain tethers 230 connected to frame 52b of prosthetic valve 50 while release members 226 extend between proximal portion 220 and distal portion 222 of tether manifold 218. Each release member 226 can extend distally from handle 210 through an orifice (not shown) in proximal portion 220 and an orifice (not shown) in distal portion 222. Rings 230b are desirably retained on release members 226 at a position between proximal portion 220 and distal portion 222. To release tethers 230 from prosthetic valve 50, release members 226 can be retracted in a proximal direction to withdraw the release members from distal portion 222 and, optionally, from proximal portion 220. Retracting release members 226 withdraws them from rings 230b such that the rings are no longer held in place by release members 226.

[0140] exist Figures 10A-10B In the example of , three release members 226 are used, each retaining a respective cord 230 coupled to a respective frame anchor 80b. Figures 10A-10B In FIG, only two release members 226 and two cords 230 are visible, with the third release member and third cord 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 may be used.

[0141] Furthermore, an equal number of tethers 230 and release members 226 is not required. For example, the ends 230b of multiple tethers 230 can be retained on a single release member. Desirably, at least three tethers 230 are used to balance the attachment of the frame 52b to the tether manifold 218. In a particular example, the number of tethers 230 is equal to the number of frame anchors 80b of the frame 52b of the prosthetic valve 50. Furthermore, in other examples, a single tether can be used to connect the frame 52b to the tether manifold 120b at multiple locations along the outflow end of the frame by forming multiple passes extending through the openings of the frame and / or the apertures 86 of the frame anchors 80b.

[0142] Each release member 226 can be slidably extended through corresponding openings in the proximal portion 220 and the distal portion 222 of the tether manifold 218 and can be actuated in any suitable manner to slide through the proximal portion 220 and the distal portion 222. For example, each release member 226 can have a proximal end portion that is operably coupled to the knob 214 on the handle 210 to control movement of the release member. Each of the release members 226 can be movable in a proximal and distal direction relative to the proximal portion 220 and the distal portion 222 of the tether manifold 218 between a distal position in which each release member 226 retains a corresponding tether 230 and a proximal position in which each release member 226 is released from the corresponding tether 230.

[0143] Once the prosthetic valve 50 is delivered to the selected implantation site in the patient (e.g., the native aortic valve), the nose cone 208 can optionally be advanced distally 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 can have an additional knob (not shown) to control the advancement of the inner shaft 206. The delivery capsule 240 can then be retracted, for example, by actuating the knob 212, to deploy the prosthetic valve 50. When the delivery capsule 240 is retracted, and as shown in FIG. Figure 10B As shown in , the prosthetic valve can radially self-expand under the elasticity of the frame 52b.

[0144] 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 tether 230. As described above, once the prosthetic valve 50 is deployed from the delivery capsule 240 and positioned at the desired implantation location, the tether 230 can be released from the frame 52b. The positioning of the valve 50 and the anchor 80b can be combined as described above. Figures 9A-9B Proceed as described.

[0145] Delivery device 200 can be configured to deliver a prosthetic valve 50 including a frame 52a. For use with frame 52a, tether 230 can be routed through aperture 86 of each leg portion 84 of each frame anchor 80a and releasably coupled to release member 226 to place the leg portion 84 of each frame anchor 80a in the delivery configuration. The same tether 230 or separate tethers 230 can be routed through both apertures of each frame anchor 80a. Prosthetic valve 50 including frame 52a can be delivered and implanted in the same manner as described above, except that deploying frame anchors 80a requires releasing both leg portions 84 of each frame anchor, which allows the leg portions of each frame anchor to return to the deployed configuration around a pair of native leaflets.

[0146] Further details regarding the attachment of the prosthetic valve 10 to the delivery devices 100 and 200 via one or more ropes or sutures are disclosed in U.S. Publication Nos. 2014 / 0343670, 2012 / 0239142, 2010 / 0049313, and 2022 / 0000619, and in WIPO Publication No. WO2021 / 195090, all of which are incorporated herein by reference.

[0147] Delivery Technology

[0148] In order to implant the prosthetic valve in the natural aortic valve via the transfemoral delivery method, the prosthetic valve is installed along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch and through the ascending aorta. The prosthetic valve is positioned in the natural aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery device, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted in the natural aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal 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 in the natural aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example, through a partial J-sternotomy or a right parasternal mini-thoracotomy, and is then advanced through the ascending aorta toward the native aortic valve.

[0149] To implant a prosthetic valve within the native mitral valve via a transseptal delivery method, the prosthetic valve is mounted in a radially compressed state along the distal portion of a delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, through the atrial septum (through a puncture made in the atrial septum), into the left atrium, and advanced toward the native mitral valve. Alternatively, the prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal 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 within the native mitral valve.

[0150] To implant a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal portion of a delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava and into the right atrium, where the prosthetic valve is positioned within the native tricuspid valve. A similar method can be used to implant a prosthetic valve within the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0151] Another delivery method is a transatrial approach, in which the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision made through the atrial wall (of the right or left atrium) to access any native heart valve. Atrial delivery can also be performed intravascularly, for example from the pulmonary veins. Yet another delivery method is a transventricular approach, in which the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision made through the right ventricular wall (usually at or near the base of the heart) to implant the prosthetic valve into the native tricuspid valve, native pulmonary valve, or pulmonary artery.

[0152] In all delivery methods, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery methods are not intended to be limiting. Any prosthetic valve disclosed herein can be implanted using any of a variety of delivery procedures and delivery devices known in the art.

[0153] Any one of the systems herein, devices, equipment etc. can be sterilized (e.g., using heat, radiation and / or chemicals etc.) to ensure that they are safe for use with patients, and as a step in the step of the method, any method in the method herein can include the sterilization of associated systems, devices, equipment etc. The example of heating / thermal sterilization includes steam sterilization and autoclaving. The example of radiation for sterilization includes but is not limited to gamma radiation and ultraviolet radiation. The example of chemicals for sterilization includes but is not limited to ethylene oxide and hydrogen peroxide. For example, hydrogen peroxide plasma can be used to complete with hydrogen peroxide sterilization.

[0154] Additional Examples of Disclosed Technology

[0155] In view of the above-mentioned implementation of the disclosed subject matter, the present application discloses the additional examples listed below. It should be noted that one feature of a separate example or one or more features of an example adopted in combination, and optionally combined with one or more features of one or more other examples, are additional examples that also fall within the disclosure of the present application.

[0156] Example 1. A prosthetic heart valve for implantation in a natural heart valve comprising a plurality of natural leaflets, the prosthetic heart valve comprising: a radially expandable frame comprising an annular body having an inflow end and an outflow end, wherein the body is radially expandable between a radially compressed state and a radially expanded state; and a valve structure comprising a plurality of leaflets disposed within and connected to the frame, and configured to regulate the flow of blood in one direction from the inflow end through the frame to the outflow end; wherein the frame comprises a plurality of frame anchors connected to the body; and wherein each frame anchor is configured to be positioned on or around a pair of free edges of two of the natural leaflets.

[0157] Example 2. The prosthetic heart valve of any example herein, in particular example 1, wherein the prosthetic heart valve is configured to be implanted within the aortic valve annulus.

[0158] Example 3. The prosthetic heart valve of any example herein, particularly any of examples 1-2, wherein the prosthetic heart valve is a self-expanding valve configured to self-expand from the radially compressed state to the radially expanded state.

[0159] Example 4. The prosthetic heart valve of any example herein, particularly any of examples 1-3, wherein the prosthetic heart valve is configured to expand from the radially compressed state to the radially expanded state by inflating a balloon of a delivery device.

[0160] Example 5. The prosthetic heart valve of any example herein, particularly any of Examples 1-4, further comprising an outer skirt at least partially covering the outer surface of the body.

[0161] Example 6. The prosthetic heart valve of any example herein, particularly example 5, wherein the outer skirt extends at least partially between each frame anchor and the body.

[0162] Example 7. The prosthetic heart valve of any example herein, particularly any of examples 1-6, wherein the body comprises a plurality of circumferentially extending struts forming a plurality of apexes at the inflow and outflow ends of the frame.

[0163] Example 8. A prosthetic heart valve according to any example herein, in particular any of Examples 1-7, wherein the body is substantially cylindrical at least near the outflow end when the prosthetic heart valve is in a radially expanded state, and wherein the body flares radially outward toward the inflow end.

[0164] Example 9. The prosthetic heart valve of any example herein, particularly any of examples 1-8, wherein the body comprises an inflow end portion, the inflow end portion comprising the inflow end, and wherein the inflow end portion flares radially outward.

[0165] Example 10. A prosthetic heart valve according to any example herein, in particular any of Examples 1-9, wherein the outflow end of the body has a first diameter, wherein the inflow end of the body has a second diameter greater than the first diameter, and wherein the second diameter is greater than the diameter of the annulus in which the prosthetic heart valve is implanted.

[0166] Example 11. The prosthetic heart valve of any example herein, particularly any of Examples 1-10, wherein each frame anchor is configured to transition from a delivery configuration to a deployed configuration to anchor the prosthetic heart valve within the native heart valve.

[0167] Example 12. The prosthetic heart valve of any example herein, in particular Example 11, wherein each frame anchor is configured to flex when the frame anchor transitions between the delivery configuration and the deployed configuration.

[0168] Example 13. The prosthetic heart valve of any example herein, particularly any of Examples 11-12, wherein each frame anchor is biased toward the deployed configuration.

[0169] Example 14. The prosthetic heart valve of any example herein, particularly any of Examples 11-13, wherein each frame anchor is configured to automatically transition from the delivery configuration to the deployed configuration when the restraining force is removed from the frame anchor.

[0170] Example 15. The prosthetic heart valve of any of the examples herein, in particular any of Examples 11-14, wherein each frame anchor comprises at least one orifice configured to engage a tether of a delivery device, wherein each frame anchor is configured to receive a restraining force from the tether, wherein each frame anchor is configured to remain in the delivery configuration while the tether applies the restraining force to the frame anchor, and wherein each frame anchor is free to transition from the delivery configuration to the deployed configuration when the tether no longer applies the restraining force to the frame anchor.

[0171] Example 16. The prosthetic heart valve of any example herein, particularly any of Examples 11-15, wherein each frame anchor is substantially U-shaped when the frame anchor is in the deployed configuration.

[0172] Example 17. A prosthetic heart valve of any example herein, in particular any of Examples 1-16, wherein the frame anchor is configured to engage the native leaflets to anchor the prosthetic heart valve in place relative to the annulus of the heart including the native heart valve to prevent retrograde blood flow.

[0173] Example 18. A prosthetic heart valve of any example herein, in particular any of Examples 1-17, wherein the body includes a plurality of circumferentially extending struts forming a plurality of vertices at the inflow and outflow ends of the frame, and wherein each frame anchor is coupled to the body at the intersection of the struts between a pair of circumferentially adjacent vertices.

[0174] Example 19. The prosthetic heart valve of any example herein, particularly any of examples 1-18, wherein each frame anchor is formed of a plastically deformable material.

[0175] Example 20. The prosthetic heart valve of any example herein, particularly any of examples 1-19, wherein each frame anchor is formed of a shape memory material.

[0176] Example 21. The prosthetic heart valve of any example herein, particularly any of examples 1-20, wherein each frame anchor is formed of the same material as at least a portion of the body.

[0177] Example 22. The prosthetic heart valve of any example herein, particularly any of examples 1-21, wherein each frame anchor is integrally formed with at least a portion of the body.

[0178] Example 23. The prosthetic heart valve of any example herein, particularly any of examples 1-21, wherein each frame anchor is formed separately from and attached to the body.

[0179] Example 24. The prosthetic heart valve of any example herein, particularly any of Examples 1-23, wherein each frame anchor is coupled to the body via one or more of a weld, an adhesive, a suture, and a mechanical connector.

[0180] Example 25. The prosthetic heart valve of any example herein, in particular any example 1-24, wherein the prosthetic heart valve is configured such that when the prosthetic heart valve is implanted within the natural heart valve, each frame anchor engages a corresponding pair of natural leaflets of the natural heart valve proximate the natural commissure of the natural heart valve.

[0181] Example 26. A prosthetic heart valve according to any example herein, in particular any of Examples 1-25, wherein the prosthetic heart valve is configured such that when the prosthetic heart valve is implanted within the native heart valve, each frame anchor is clamped to a corresponding pair of native leaflets of the native heart valve.

[0182] Example 27. The prosthetic heart valve of any example herein, particularly any of examples 1-26, wherein each frame anchor comprises a middle portion and a pair of leg portions extending away from the middle portion.

[0183] Example 28. The prosthetic heart valve of any example herein, in particular any example 27, wherein the prosthetic heart valve is configured such that when the prosthetic heart valve is implanted within the native heart valve, each leg portion engages the native leaflets of the native heart valve proximate the native commissure of the native heart valve.

[0184] Example 29. The prosthetic heart valve of any example herein, particularly any of examples 27-28, wherein each leg portion is integrally formed with the middle portion.

[0185] Example 30. A prosthetic heart valve of any example herein, in particular any of Examples 27-29, wherein for each frame anchor, the middle portion is fixed in position relative to the body, and wherein each leg portion is configured to pivot relative to the middle portion to transition the frame anchor between a delivery configuration and a deployed configuration.

[0186] Example 31. The prosthetic heart valve of any example herein, in particular Example 30, wherein each leg portion is configured to pivot about an axis perpendicular to a plane extending tangentially to the body to which the frame anchor is attached.

[0187] Example 32. A prosthetic heart valve of any example herein, in particular any of Examples 30-31, wherein when the frame anchor is in the delivery configuration, each leg portion extends away from the middle portion toward the outflow end, and wherein when the frame anchor is in the deployed configuration, each leg portion extends away from the middle portion toward the inflow end.

[0188] Example 33. The prosthetic heart valve of any example herein, particularly Example 32, wherein each leg portion extends to and continues beyond the outflow end when the frame anchor is in the delivery configuration.

[0189] Example 34. The prosthetic heart valve of any example herein, particularly any of Examples 30-33, wherein each leg portion includes an aperture configured to engage a tether of a delivery device.

[0190] Example 35. The prosthetic heart valve of any example herein, particularly any of Examples 30-34, wherein the frame anchor is substantially U-shaped when the frame anchor is in the delivery configuration.

[0191] Example 36. A prosthetic heart valve of any example herein, in particular any of Examples 27-29, wherein for each frame anchor, the pair of leg portions includes a first leg portion and a second leg portion, wherein the first leg portion is fixed in position relative to the body, and wherein one or both of the middle portion and the second leg portion are configured to pivot relative to the first leg portion to transition the frame anchor between a delivery configuration and a deployed configuration.

[0192] Example 37. The prosthetic heart valve of any example herein, in particular Example 36, wherein the intermediate portion is configured to pivot about an axis perpendicular to a plane extending tangentially to the body to which the frame anchor is attached.

[0193] Example 38. A prosthetic heart valve of any example herein, in particular any of Examples 36-37, wherein when the frame anchor is in the delivery configuration, the second leg portion extends away from the first leg portion toward the outflow end; and wherein when the frame anchor is in the deployed configuration, the second leg portion extends away from the first leg portion toward the inflow end.

[0194] Example 39. The prosthetic heart valve of any example herein, particularly Example 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.

[0195] Example 40. The prosthetic heart valve of any example herein, in particular any of examples 36-39, wherein the second leg portion is not connected to the body.

[0196] Example 41. The prosthetic heart valve of any example herein, particularly any of Examples 36-40, wherein the second leg portion includes an aperture configured to engage a tether of a delivery device.

[0197] Example 42. The prosthetic heart valve of any example herein, particularly any of Examples 36-41, wherein the first leg portion and the second leg portion are substantially collinear when the frame anchor is in the delivery configuration.

[0198] Example 43. A prosthetic heart valve for implantation in a natural heart valve comprising a plurality of natural leaflets, the prosthetic heart valve comprising: a radially expandable frame comprising an annular body having an inflow end and an outflow end, wherein the body is radially expandable between a radially compressed state and a radially expanded state; and a valve structure comprising a plurality of leaflets disposed within and coupled to the frame and configured to regulate the flow of blood in one direction from the inflow end through the frame to the outflow end; wherein the frame comprises a plurality of frame anchors coupled to the body, wherein each frame anchor comprises a first leg portion, a second leg portion, and a second leg portion. a leg portion and a middle portion, wherein each of the first leg portion and the second leg portion extends away from the middle portion; wherein each frame anchor is configured to bend relative to the body to transition between a delivery configuration and a deployed configuration, and wherein for each frame anchor, when the frame anchor is in the deployed configuration and when the prosthetic heart valve is implanted within the native heart valve, the first leg portion extends adjacent to a first leaflet of the plurality of native leaflets, the second leg portion extends adjacent to a second leaflet of the plurality of native leaflets, and the middle portion is positioned adjacent to a free edge of each of the first leaflet and the second leaflet.

[0199] Example 44. The prosthetic heart valve of any example herein, in particular example 43, wherein each frame anchor is substantially U-shaped when the frame anchor is in the deployed configuration.

[0200] Example 45. A prosthetic heart valve of any example herein, in particular any of Examples 43-44, wherein 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.

[0201] Example 46. A prosthetic heart valve of any example herein, in particular any of Examples 43-45, wherein for each frame anchor, when the frame anchor is in the deployed configuration and when the prosthetic heart valve is implanted within the native heart valve, the first leg portion presses against the first leaflet and the second leg portion presses against the second leaflet.

[0202] Example 47. The prosthetic heart valve of any example herein, particularly any of Examples 43-46, wherein each frame anchor is substantially U-shaped when the frame anchor is in the delivery configuration.

[0203] Example 48. The prosthetic heart valve of any example herein, particularly any of Examples 43-47, wherein 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.

[0204] Example 49. The prosthetic heart valve of any example herein, in particular any of Examples 43-48, wherein for each frame anchor, one or both of the first leg portion and the second leg portion includes an orifice configured to engage a tether of a delivery device.

[0205] Example 50. The prosthetic heart valve of any example herein, particularly any of Examples 43-49, wherein for each frame anchor, the intermediate portion is fixedly coupled to the body.

[0206] Example 51. The prosthetic heart valve of any example herein, particularly any of Examples 43-50, wherein for each frame anchor, the first leg portion is fixedly coupled to the body.

[0207] Example 52. The prosthetic heart valve of any example herein, particularly any of examples 1-51, wherein each frame anchor is at least partially covered by a protective covering.

[0208] Example 53. A prosthetic heart valve delivery assembly comprising: a prosthetic heart valve for implantation within a native heart valve comprising a plurality of native leaflets, the prosthetic heart valve comprising: a radially expandable frame comprising an annular body having an inflow end and an outflow end, wherein the body is radially expandable between a radially compressed state and a radially expanded state; and a valve structure comprising a plurality of leaflets disposed within and coupled to the frame and configured to regulate the flow of blood in one direction from the inflow end through the frame to the outflow end. flow; wherein the frame includes a plurality of frame anchors coupled to the body, and wherein each frame anchor is configured to be positioned on or around a pair of free edges of two of the natural leaflets; and a delivery device for delivering the prosthetic heart valve to an implantation site, the delivery device comprising: a delivery sac configured to accommodate the prosthetic heart valve in a radially compressed state; and a plurality of ropes, each rope configured to be releasably connected to a corresponding frame anchor of the prosthetic heart valve and to apply a restraining force to the corresponding frame anchor.

[0209] Example 54. The prosthetic heart valve delivery assembly of any example herein, in particular Example 53, wherein for each tether and the corresponding frame anchor, the frame anchor includes an orifice and the tether extends through the orifice when the prosthetic heart valve is contained within the delivery sac.

[0210] Example 55. A prosthetic heart valve delivery assembly of any example herein, in particular any of Examples 53-54, wherein each frame anchor is configured to transition from a delivery configuration to a deployment configuration to anchor the prosthetic heart valve within the native heart valve, and wherein for each tether and the corresponding frame anchor, the tether is configured to maintain the frame anchor in the delivery configuration while the tether applies the restraining force to the frame anchor, and the frame anchor automatically transitions from the delivery configuration to the deployment configuration when the tether no longer applies the restraining force to the frame anchor.

[0211] Example 56. A prosthetic heart valve delivery assembly of any example herein, in particular any of Examples 53-55, wherein when the tether is connected to the frame anchor and the restraining force is applied to the frame anchor, the tether maintains the end of the frame including the frame anchor in an at least partially radially compressed state.

[0212] Example 57. A prosthetic heart valve delivery assembly of any example herein, in particular any of Examples 53-56, wherein the delivery device further comprises: a handle portion; a first shaft extending between the handle portion and the delivery sac; an inner shaft configured to extend through the prosthetic heart valve when the prosthetic heart valve is received within the delivery sac; and a nose cone mounted on a distal portion of the inner shaft distal to the delivery sac.

[0213] Example 58. Any of the examples herein, in particular the prosthetic heart valve delivery assembly of Example 57, further comprising: a tether manifold comprising a proximal portion and a distal portion axially spaced apart from each other; and a plurality of release members extending from the handle portion through the first axis, through the proximal portion, and at least partially through the distal portion; wherein each tether comprises a first end attached to the proximal portion and a second end retained on a corresponding release member between the proximal portion and the distal portion; and wherein the delivery device is configured such that the release member is withdrawn from one or both of the distal portion and the proximal portion such that the second end of the tether is no longer held in place by the release member.

[0214] Example 59. The prosthetic heart valve delivery assembly of any example herein, in particular example 58, wherein each release member comprises a proximal portion coupled to a knob on the handle portion to control movement of the release member.

[0215] Example 60. A prosthetic heart valve delivery assembly of any example herein, in particular any of Examples 58-59, wherein each release member is movable in a proximal and distal direction relative to the proximal and distal portions of the tether manifold between a distal position in which each release member retains the corresponding tether and a proximal position in which each release member is released from the corresponding tether.

[0216] Example 61. The prosthetic heart valve delivery assembly of any example herein, particularly any of examples 58-60, wherein each second end comprises a ring extending around the respective release member.

[0217] Example 62. The prosthetic heart valve delivery assembly of any example herein, particularly any of Examples 58-61, wherein each release member comprises one or more of a rod, a bar, a wire, and a cable.

[0218] Example 63. A prosthetic heart valve delivery assembly of any example herein, in particular any of Examples 57-62, wherein the delivery device is configured such that the prosthetic heart valve can be released from the delivery sac by one or both of: advancing the nose cone distally away from the adjacent end of the delivery sac by advancing the inner axis distally toward the handle portion; and retracting the delivery sac proximally toward the handle portion.

[0219] Example 64. The prosthetic heart valve of any example herein, in particular any one of examples 1-52, wherein the prosthetic heart valve is sterilized.

[0220] Example 65. The prosthetic heart valve delivery assembly of any example herein, particularly any of Examples 53-63, wherein the delivery device and the prosthetic heart valve are sterilized.

[0221] Example 66. A method comprising sterilizing the prosthetic heart valve or prosthetic heart valve delivery assembly of any example herein, particularly any of Examples 1-65.

[0222] Unless otherwise stated, features described herein with respect to any example may be combined with other features described in any one or more of the other examples. For example, any one or more features of one prosthetic heart valve may be combined with any one or more features of another prosthetic heart valve. As another example, any one or more features of one prosthetic heart valve delivery assembly may be combined with any one or more features of another prosthetic heart valve delivery assembly.

[0223] In view of the many possible ways in which the principles of the present disclosure can be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the present disclosure, nor should they be taken as limiting the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A prosthetic heart valve for implantation in a natural heart valve comprising a plurality of natural leaflets, characterized in that The prosthetic heart valve includes: a radially expandable frame, the radially expandable frame including an annular body having an inflow end and an outflow end, wherein the body is radially expandable between a radially compressed state and a radially expanded state; and a valve structure, the valve structure including a plurality of leaflets disposed within and connected to the frame, and configured to regulate the flow of blood in one direction from the inflow end through the frame to the outflow end; wherein the frame includes a plurality of frame anchors connected to the body; wherein each frame anchor is configured to be positioned on or around a pair of free edges of two of the natural leaflets; and wherein each frame anchor is at least partially covered by a protective covering.

2. The prosthetic heart valve according to claim 1, characterized in that The prosthetic heart valve is configured to be implanted within the aortic valve annulus.

3. The prosthetic heart valve according to any one of claims 1 to 2, characterized in that Wherein the prosthetic heart valve is a self-expanding valve configured to self-expand from the radially compressed state to the radially expanded state.

4. The prosthetic heart valve according to any one of claims 1 to 3, characterized in that wherein the prosthetic heart valve is configured to expand from the radially compressed state to the radially expanded state by inflating a balloon of a delivery device.

5. The prosthetic heart valve according to any one of claims 1 to 4, characterized in that Also included is an outer skirt at least partially covering the outer surface of the main body.

6. The prosthetic heart valve according to claim 5, characterized in that wherein the outer skirt extends at least partially between each frame anchor and the body.

7. The prosthetic heart valve according to any one of claims 1 to 6, characterized in that The body includes a plurality of circumferentially extending struts forming a plurality of apexes at the inflow end and the outflow end of the frame.

8. The prosthetic heart valve according to any one of claims 1 to 7, characterized in that Wherein when the prosthetic heart valve is in a radially expanded state, the body is substantially cylindrical at least proximate the outflow end, and wherein the body flares radially outward toward the inflow end.

9. The prosthetic heart valve according to any one of claims 1 to 8, characterized in that The body includes an inflow end portion including the inflow end, and the inflow end portion flares radially outward.

10. The prosthetic heart valve according to any one of claims 1 to 9, characterized in that The outflow end of the body has a first diameter, the inflow end of the body has a second diameter that is larger than the first diameter, and the second diameter is larger than a diameter of an annulus in which the prosthetic heart valve is implanted.

11. The prosthetic heart valve according to any one of claims 1 to 10, characterized in that Each frame anchor is configured to transition from a delivery configuration to a deployed configuration to anchor the prosthetic heart valve within the native heart valve.

12. The prosthetic heart valve according to claim 11, characterized in that Each frame anchor is configured to flex when the frame anchor transitions between the delivery configuration and the deployed configuration.

13. The prosthetic heart valve according to any one of claims 11 to 12, characterized in that Each frame anchor is biased toward the deployed configuration.

14. The prosthetic heart valve according to any one of claims 11 to 13, characterized in that Each frame anchor is configured to automatically transition from the delivery configuration to the deployed configuration when a restraining force is removed from the frame anchor.

15. The prosthetic heart valve according to any one of claims 11 to 14, characterized in that wherein each frame anchor comprises at least one aperture configured to engage a tether of a delivery device, wherein each frame anchor is configured to receive a restraining force from the tether, wherein each frame anchor is configured to remain in the delivery configuration while the tether applies the restraining force to the frame anchor, and wherein each frame anchor is free to transition from the delivery configuration to the deployed configuration when the tether no longer applies the restraining force to the frame anchor.

16. The prosthetic heart valve according to any one of claims 11 to 15, characterized in that Each frame anchor is substantially U-shaped when the frame anchor is in the deployed configuration.

17. The prosthetic heart valve according to any one of claims 1 to 16, characterized in that Wherein the frame anchor is configured to engage the native valve leaflets to anchor the prosthetic heart valve in place relative to the annulus of a heart including the native heart valve to prevent retrograde blood flow.

18. The prosthetic heart valve according to any one of claims 1 to 17, characterized in that wherein the body includes a plurality of circumferentially extending struts forming a plurality of vertices at the inflow and outflow ends of the frame, and wherein each frame anchor is coupled to the body at an intersection of a strut between a pair of circumferentially adjacent vertices.

19. The prosthetic heart valve according to any one of claims 1 to 18, characterized in that Each frame anchor is formed of a plastically deformable material.

20. The prosthetic heart valve according to any one of claims 1 to 19, characterized in that Each frame anchor is formed of a shape memory material.

21. The prosthetic heart valve according to any one of claims 1 to 20, characterized in that Each frame anchor is formed from the same material as at least a portion of the body.

22. The prosthetic heart valve according to any one of claims 1 to 21, characterized in that Each frame anchor is integrally formed with at least a portion of the body.

23. The prosthetic heart valve according to any one of claims 1 to 21, characterized in that Each frame anchor is formed separately from the body and is coupled to the body.

24. The prosthetic heart valve according to any one of claims 1 to 23, characterized in that Each frame anchor is coupled to the body via one or more of a weld, an adhesive, a suture, and a mechanical connector.

25. The prosthetic heart valve according to any one of claims 1 to 24, characterized in that wherein the prosthetic heart valve is configured such that when the prosthetic heart valve is implanted within the native heart valve, each frame anchor engages a corresponding pair of native leaflets of the native heart valve proximate the native commissures of the native heart valve.

26. The prosthetic heart valve according to any one of claims 1 to 25, characterized in that The prosthetic heart valve is configured such that each frame anchor is clamped to a corresponding pair of native leaflets of the native heart valve when the prosthetic heart valve is implanted within the native heart valve.

27. The prosthetic heart valve according to any one of claims 1 to 26, characterized in that Each frame anchor includes a middle portion and a pair of leg portions extending away from the middle portion.

28. The prosthetic heart valve according to claim 27, characterized in that Wherein the prosthetic heart valve is configured such that when the prosthetic heart valve is implanted within the native heart valve, each leg portion engages the native leaflets of the native heart valve proximate the native commissures of the native heart valve.

29. The prosthetic heart valve according to any one of claims 27-28, characterized in that Each leg portion is integrally formed with the middle portion.

30. The prosthetic heart valve according to any one of claims 27 to 29, characterized in that Wherein for each frame anchor, the middle portion is fixed in position relative to the body, and wherein each leg portion is configured to pivot relative to the middle portion to transition the frame anchor between a delivery configuration and a deployed configuration.

31. The prosthetic heart valve according to claim 30, characterized in that Each leg portion is configured to pivot about an axis that is perpendicular to a plane extending tangentially to the body to which the frame anchor is attached.

32. The prosthetic heart valve according to any one of claims 30-31, characterized in that wherein each leg portion extends away from the middle portion toward the outflow end when the frame anchor is in the delivery configuration, and wherein each leg portion extends away from the middle portion toward the inflow end when the frame anchor is in the deployed configuration.

33. The prosthetic heart valve according to claim 32, characterized in that wherein each leg portion extends to and continues beyond the outflow end when the frame anchor is in the delivery configuration.

34. The prosthetic heart valve according to any one of claims 30 to 33, characterized in that Wherein each leg portion includes an aperture configured to engage a cord of a delivery device.

35. The prosthetic heart valve according to any one of claims 30 to 34, characterized in that Wherein the frame anchor is substantially U-shaped when the frame anchor is in the delivery configuration.

36. The prosthetic heart valve according to any one of claims 27 to 29, characterized in that wherein for each frame anchor, the pair of leg portions includes a first leg portion and a second leg portion, wherein the first leg portion is fixed in position relative to the body, and wherein one or both of the middle portion and the second leg portion are configured to pivot relative to the first leg portion to transition the frame anchor between a delivery configuration and a deployed configuration.

37. The prosthetic heart valve according to claim 36, characterized in that wherein the intermediate portion is configured to pivot about an axis that is perpendicular to a plane extending tangentially to the body to which the frame anchor is attached.

38. The prosthetic heart valve according to any one of claims 36-37, characterized in that wherein when the frame anchor is in the delivery configuration, the second leg portion extends away from the first leg portion toward the outflow end; and wherein when the frame anchor is in the deployed configuration, the second leg portion extends away from the first leg portion toward the inflow end.

39. The prosthetic heart valve according to claim 38, characterized in that 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.

40. The prosthetic heart valve according to any one of claims 36 to 39, characterized in that Wherein the second leg portion is not connected to the main body.

41. The prosthetic heart valve according to any one of claims 36 to 40, characterized in that Wherein the second leg portion includes an aperture configured to engage a cord of a delivery device.

42. The prosthetic heart valve according to any one of claims 36 to 41, characterized in that Wherein when the frame anchor is in the delivery configuration, the first leg portion and the second leg portion are substantially co-linear.

43. A prosthetic heart valve for implantation in a natural heart valve comprising a plurality of natural leaflets, characterized in that The prosthetic heart valve comprises: a radially expandable frame comprising an annular body having an inflow end and an outflow end, wherein the body is radially expandable between a radially compressed state and a radially expanded state; and a valve structure comprising a plurality of leaflets disposed within and coupled to the frame and configured to regulate the flow of blood in one direction from the inflow end through the frame to the outflow end; wherein the frame comprises a plurality of frame anchors coupled to the body, wherein each frame anchor comprises a first leg portion, a second leg portion, and a middle portion, wherein the first leg portion and the second leg portion are connected to each other. each of which extends away from the middle portion; wherein each frame anchor is configured to bend relative to the body to transition between a delivery configuration and a deployed configuration, and wherein for each frame anchor, when the frame anchor is in the deployed configuration and when the prosthetic heart valve is implanted within the native heart valve, the first leg portion extends alongside a first leaflet of the plurality of native leaflets, the second leg portion extends alongside a second leaflet of the plurality of native leaflets, and the middle portion is positioned adjacent to a free edge of each of the first leaflet and the second leaflet, and wherein each frame anchor is at least partially covered by a protective covering.

44. The prosthetic heart valve according to claim 43, characterized in that Each frame anchor is substantially U-shaped when the frame anchor is in the deployed configuration.

45. The prosthetic heart valve according to any one of claims 43-44, characterized in that Wherein 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.

46. ​​The prosthetic heart valve according to any one of claims 43 to 45, characterized in that Wherein for each frame anchor, when the frame anchor is in the deployed configuration and when the prosthetic heart valve is implanted within the native heart valve, the first leg portion presses against the first leaflet and the second leg portion presses against the second leaflet.

47. The prosthetic heart valve according to any one of claims 43 to 46, characterized in that Each frame anchor is substantially U-shaped when the frame anchor is in the delivery configuration.

48. The prosthetic heart valve according to any one of claims 43 to 47, characterized in that Wherein for each frame anchor, when the frame anchor is in the delivery configuration, the first leg portion and the second leg portion are substantially collinear.

49. The prosthetic heart valve according to any one of claims 43 to 48, characterized in that Wherein, for each frame anchor, one or both of the first leg portion and the second leg portion include an aperture configured to engage a tether of a delivery device.

50. The prosthetic heart valve according to any one of claims 43 to 49, characterized in that Wherein for each frame anchor, the intermediate portion is fixedly coupled to the body.

51. The prosthetic heart valve according to any one of claims 43 to 50, characterized in that Wherein for each frame anchor, the first leg portion is fixedly coupled to the body.

52. A prosthetic heart valve delivery assembly, characterized in that include: A prosthetic heart valve for implantation in a natural heart valve comprising a plurality of natural leaflets, the prosthetic heart valve comprising: a radially expandable frame comprising an annular body having an inflow end and an outflow end, wherein the body is radially expandable between a radially compressed state and a radially expanded state; and a valve structure comprising a plurality of leaflets disposed within and coupled to the frame and configured to regulate the flow of blood in one direction from the inflow end through the frame to the outflow end; wherein the frame comprises a plurality of frame members coupled to the body anchors, and each frame anchor is configured to be positioned on or around a pair of free edges of two of the natural leaflets; and a delivery device for delivering the prosthetic heart valve to an implantation site, the delivery device comprising: a delivery bag configured to accommodate the prosthetic heart valve in a radially compressed state; and a plurality of ropes, each rope being configured to be releasably connected to a corresponding frame anchor of the prosthetic heart valve and to apply a restraining force to the corresponding frame anchor; and wherein each frame anchor is at least partially covered by a protective covering.

53. The prosthetic heart valve delivery assembly of claim 52, wherein Wherein for each tether and the corresponding frame anchor, the frame anchor includes an aperture, and the tether extends through the aperture when the prosthetic heart valve is received within the delivery bag.

54. A prosthetic heart valve delivery assembly according to any one of claims 52-53, characterized in that wherein each frame anchor is configured to transition from a delivery configuration to a deployment configuration to anchor the prosthetic heart valve within the native heart valve, and wherein for each tether and the corresponding frame anchor, the tether is configured to maintain the frame anchor in the delivery configuration while the tether applies the restraining force to the frame anchor, and wherein the frame anchor automatically transitions from the delivery configuration to the deployment configuration when the tether no longer applies the restraining force to the frame anchor.

55. A prosthetic heart valve delivery assembly according to any one of claims 52-54, characterized in that wherein when the tether is connected to the frame anchor and the restraining force is applied to the frame anchor, the tether maintains the end of the frame including the frame anchor in an at least partially radially compressed state.

56. A prosthetic heart valve delivery assembly according to any one of claims 52-55, characterized in that The delivery device further comprises: a handle portion; a first shaft extending between the handle portion and the delivery sac; an inner shaft configured to extend through the prosthetic heart valve when the prosthetic heart valve is received within the delivery sac; and a nose cone mounted on a distal portion of the inner shaft distal to the delivery sac.

57. The prosthetic heart valve delivery assembly of claim 56, wherein Also includes: a tether manifold comprising a proximal portion and a distal portion axially spaced from one another; 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; wherein each tether comprises a first end attached to the proximal portion and a second end retained on a corresponding release member between the proximal and distal portions; and wherein the delivery apparatus is configured such that upon withdrawal of the release member from one or both of the distal and proximal portions, the second end of the tether is no longer retained in place by the release member.

58. The prosthetic heart valve delivery assembly of claim 57, wherein Each release member includes a proximal portion coupled to a knob on the handle portion to control movement of the release member.

59. A prosthetic heart valve delivery assembly according to any one of claims 57-58, characterized in that Each release member is movable in a proximal and distal direction relative to the proximal and distal portions of the tether manifold between a distal position in which each release member retains a corresponding tether and a proximal position in which each release member is released from a corresponding tether.

60. A prosthetic heart valve delivery assembly according to any one of claims 57-59, characterized in that Each second end includes a loop extending around a corresponding release member.

61. A prosthetic heart valve delivery assembly according to any one of claims 57-60, characterized in that Each release member comprises one or more of a rod, a bar, a wire, and a cable.

62. A prosthetic heart valve delivery assembly according to any one of claims 56-61, characterized in that wherein the delivery apparatus is configured such that the prosthetic heart valve can be released from the delivery sac by one or both of: advancing the nose cone distally away from an adjacent end of the delivery sac by advancing the inner shaft distally toward the handle portion; and proximally retracting the delivery sac toward the handle portion.

63. A prosthetic heart valve delivery assembly according to any one of claims 52-62, characterized in that wherein the delivery device and the prosthetic heart valve are sterile.

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