Prosthetic valve

Abstract

A prosthetic heart valve includes a self-expanding frame and a plurality of prosthetic valve leaflets positioned within an interior of the frame. A ventricular anchor extends from a downstream portion of the frame and is shaped for capturing a native leaflet. Barbs are preferably disposed along the outer surface of the frame to enhance fixation. The self-expanding frame may include an inner frame for supporting the prosthetic valve leaflet and an outer frame for sealing against tissue of the native heart valve. The inner frame and the outer frame may be attached via a flexible intermediate member to allow the inner frame to move relative to the outer frame. The outer frame may be more conformable than the inner frame, and the outer frame may include an axial recess for receiving the ventricular anchor and thereby reducing the profile after implantation. The prosthetic heart valve is preferably sized to replace a native tricuspid valve.

Description

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 63 / 436,051, filed Dec. 29, 2022, and U.S. Provisional Application No. 63 / 533,458, filed Aug. 18, 2023, the entire contents of each of which are hereby incorporated by reference. Technical Field

[0002] Certain examples disclosed herein generally relate to prostheses for implantation within a lumen or body cavity. In particular, in some examples, the prosthesis relates to a replacement heart valve, such as a replacement mitral heart valve or a replacement tricuspid heart valve. Background Art

[0003] Human heart valves, including the aortic, pulmonary, mitral, and tricuspid valves, essentially act as one - way valves that operate in synchrony with the pumping of the heart. The valves allow blood to flow downstream but prevent blood from flowing upstream. Diseased heart valves exhibit impairments, such as stenosis or regurgitation, which inhibit the valve's ability to control blood flow. Such impairments reduce the heart's blood - pumping efficiency and can lead to debilitating and life - threatening conditions. For example, valvular insufficiency can result in conditions such as cardiac hypertrophy and ventricular dilation. Accordingly, a great deal of effort has been made to develop methods and devices for repairing or replacing damaged heart valves.

[0004] Prostheses exist to correct problems associated with damaged heart valves. For example, mechanical and tissue - based heart valve prostheses can be used to replace damaged native heart valves. Recently, a great deal of effort has been dedicated to developing replacement heart valves, particularly tissue - based replacement heart valves, which can be delivered with less trauma to the patient compared to open - heart surgery. Replacement valves are designed to be delivered via minimally invasive surgery and even percutaneous procedures. Such replacement valves typically include prosthetic valve leaflets that are attached to an expandable frame, which is then delivered to the annulus of the native valve.

[0005] The development of prostheses, including but not limited to replacement heart valves, has proven to be particularly challenging, where the replacement heart valve can be compressed for delivery and then controllably expanded for controlled placement. Additional challenges involve the ability of such prostheses to be fixed relative to tissue within the lumen (e.g., any tissue within a body lumen or body cavity) in a manner that prevents damage.

[0006] Delivering a prosthesis to a desired location within the human body, such as delivering a replacement heart valve to the mitral valve, can also be challenging. Gaining access to perform surgery in the heart or other anatomical locations may require passing through tortuous vasculature or through an open or semi-open surgical percutaneous delivery device. The ability to control prosthesis deployment at the desired location is also challenging. Summary of the Invention

[0007] Examples of the present disclosure may relate to an implant, which may include a prosthesis, such as but not limited to a replacement heart valve. The replacement heart valve may include a replacement mitral heart valve or a replacement tricuspid heart valve. In some examples, a replacement heart valve and a method for delivering the replacement heart valve to an autologous heart valve (such as the mitral valve, aortic valve, or tricuspid valve) are provided.

[0008] Improved anchoring of a prosthetic valve to an autologous implantation site may be disclosed herein. Improved interaction between the tissue of the autologous implantation site and the prosthetic valve may be disclosed herein. The configuration of a prosthetic heart valve for accommodating a pacemaker lead may be disclosed herein.

[0009] Examples of the present disclosure may include a prosthetic heart valve for replacing the function of an autologous heart valve. The prosthetic heart valve may include a self-expanding frame sized to be deployed within the autologous heart valve, the frame having an outer surface for pressing against the tissue of the autologous heart valve. The prosthetic heart valve may include a plurality of prosthetic valve leaflets positioned within the interior of the frame, the leaflets configured to allow flow in a first direction and prevent flow in a second direction. The prosthetic heart valve may include a fabric skirt covering at least a portion of the outer surface of the frame. The prosthetic heart valve may include a plurality of ventricular anchors extending from a downstream portion of the frame and shaped to capture the autologous leaflets of the autologous heart valve between the anchors and the outer surface of the frame. A plurality of barbs may be provided along the outer surface of the frame, and the ventricular anchors press the autologous leaflets against the barbs to fix the prosthetic heart valve within the autologous heart valve.

[0010] Examples of the present disclosure may include a prosthetic valve configured to be deployed to an autologous valve. The prosthetic valve may include one or more prosthetic valve leaflets and a valve body supporting the one or more prosthetic valve leaflets, wherein at least a portion of the prosthetic valve includes a material configured to reduce tissue formation or thrombus formation along the portion of the prosthetic valve.

[0011] Examples of the present disclosure may include a method. The method may include deploying a prosthetic valve to an autologous valve. The prosthetic valve may include one or more prosthetic valve leaflets and a valve body supporting the one or more prosthetic valve leaflets, wherein at least a portion of the prosthetic valve comprises a material configured to reduce tissue formation or thrombus formation along the portion of the prosthetic valve.

[0012] Examples of the present disclosure may include a prosthetic valve configured to be deployed to an autologous valve. The prosthetic valve may include one or more prosthetic valve leaflets and a valve body supporting the one or more prosthetic valve leaflets, wherein at least a portion of the prosthetic valve comprises a frame having a rough surface.

[0013] Examples of the present disclosure may include a method. The method may include deploying a prosthetic valve to an autologous valve. The prosthetic valve may include one or more prosthetic valve leaflets and a valve body supporting the one or more prosthetic valve leaflets, wherein at least a portion of the prosthetic valve comprises a frame having a rough surface.

[0014] Examples of the present disclosure may include a prosthetic valve configured to be deployed to an autologous valve having autologous valve leaflets. The prosthetic valve may include: one or more prosthetic valve leaflets; a valve body supporting the one or more prosthetic valve leaflets, the valve body including one or more grasping features configured to be positioned radially medial to one or more of the autologous valve leaflets; and one or more anchors configured to be positioned radially lateral to the one or more of the autologous valve leaflets and to press the one or more of the autologous valve leaflets toward the one or more grasping features to reduce movement of the one or more of the autologous valve leaflets relative to the valve body.

[0015] Examples of the present disclosure may include a method. The method may include deploying a prosthetic valve to an autologous valve. The prosthetic valve may include: one or more prosthetic valve leaflets; a valve body supporting the one or more prosthetic valve leaflets, the valve body including one or more grasping features configured to be positioned radially medial to one or more of the autologous valve leaflets; and one or more anchors configured to be positioned radially lateral to the one or more of the autologous valve leaflets and to press the one or more of the autologous valve leaflets toward the one or more grasping features to reduce movement of the one or more of the autologous valve leaflets relative to the valve body.

[0016] Examples of the present disclosure may include a prosthetic valve configured to be deployed to a native valve having native valve leaflets. The prosthetic valve may include one or more prosthetic valve leaflets, a valve body supporting the one or more prosthetic valve leaflets, and one or more anchors extending from the valve body and configured to be positioned radially outside one or more of the native valve leaflets to capture the one or more native valve leaflets. At least a portion of the prosthetic valve may include one or more gripping features configured to engage the surface of the native valve when one of the anchors fails to capture the one or more native valve leaflets.

[0017] Examples of the present disclosure may include a method. The method may include deploying a prosthetic valve to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets, a valve body supporting the one or more prosthetic valve leaflets, and one or more anchors extending from the valve body and configured to be positioned radially outside one or more of the native valve leaflets to capture the one or more native valve leaflets. At least a portion of the prosthetic valve may include one or more gripping features configured to engage the surface of the native valve when one of the anchors fails to capture the one or more native valve leaflets.

[0018] Examples of the present disclosure may include a prosthetic valve configured to be deployed to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets and a valve body supporting the one or more prosthetic valve leaflets and having an outer surface, wherein the outer surface of the valve body includes a channel for a pacemaker lead to pass through.

[0019] Examples of the present disclosure may include a method. The method may include deploying a prosthetic valve to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets and a valve body supporting the one or more prosthetic valve leaflets and having an outer surface, wherein the outer surface of the valve body includes a channel for a pacemaker lead to pass through.

[0020] Examples of the present disclosure may include a prosthetic valve configured to be deployed to an autologous valve. The prosthetic valve may include one or more prosthetic valve leaflets and a valve body. The valve body may include: an inner frame that supports the one or more prosthetic valve leaflets and has a proximal portion and a distal portion; and an outer frame that is positioned radially outward of the inner frame and has a proximal portion, a distal portion, and an outer surface that faces radially outward from the prosthetic valve. The proximal portion of the outer frame is coupled to the proximal portion of the inner frame, and the distal portion of the outer frame is spaced apart from the inner frame by a gap. The prosthetic valve may include a plurality of anchors, each anchor being coupled to the inner frame and having a hook shape and extending radially outward from the inner frame. A first anchor of the plurality of anchors has a tip positioned radially outward of the outer frame and overlapping the outer surface. A second anchor of the plurality of anchors has a tip positioned distally of the outer frame and at least partially recessed radially inward from the outer surface.

[0021] Examples of the present disclosure may include a method. The method may include deploying a prosthetic valve to an autologous valve. The prosthetic valve may include: one or more prosthetic valve leaflets; and a valve body that includes an inner frame and an outer frame. The inner frame supports the one or more prosthetic valve leaflets and has a proximal portion and a distal portion. The outer frame is positioned radially outward of the inner frame and has a proximal portion, a distal portion, and an outer surface that faces radially outward from the prosthetic valve. The proximal portion of the outer frame is coupled to the proximal portion of the inner frame, and the distal portion of the outer frame is spaced apart from the inner frame by a gap. The prosthetic valve may also include a plurality of anchors, each anchor being coupled to the inner frame and having a hook shape and extending radially outward from the inner frame. A first anchor of the plurality of anchors has a tip positioned radially outward of the outer frame and overlapping the outer surface. A second anchor of the plurality of anchors has a tip positioned distally of the outer frame and at least partially recessed radially inward from the outer surface.

[0022] Examples of the present disclosure may include a prosthetic valve configured to be deployed to an autologous valve. The prosthetic valve may include one or more prosthetic valve leaflets and a valve body. The prosthetic valve may include: one or more hook-arm anchors coupled to the valve body, each hook-arm anchor being adapted to hook a leaflet of the autologous valve to anchor to the autologous valve; and one or more snap anchors coupled to the valve body, each snap anchor being adapted to snap a portion of the autologous valve to anchor to the autologous valve.

[0023] Examples of the present disclosure may include a method. The method may include deploying a prosthetic valve to an autologous valve. The prosthetic valve may include: one or more prosthetic valve leaflets; a valve body that supports the one or more prosthetic valve leaflets; one or more hook arm anchors coupled to the valve body, and each hook arm anchor being adapted to hook a leaflet of the autologous valve to anchor to the autologous valve; and one or more snap anchors coupled to the valve body, and each snap anchor being adapted to snap a portion of the autologous valve to anchor to the autologous valve.

[0024] Examples of the present disclosure may include a prosthetic valve configured to be deployed to an autologous valve. The prosthetic valve may include one or more prosthetic valve leaflets and a valve body that supports the one or more prosthetic valve leaflets and has a proximal portion and a distal portion. The prosthetic valve may include: one or more hook arm anchors coupled to the valve body, and each hook arm anchor being adapted to hook a leaflet of the autologous valve to anchor to the autologous valve; and one or more support arms coupled to the valve body, and each support arm having a proximal portion coupled to the valve body and a distal portion that projects from the valve body in a distal direction and is configured to extend into the ventricle, the one or more support arms being adapted to stabilize the prosthetic valve within the autologous valve.

[0025] Examples of the present disclosure may include a method. The method may include deploying a prosthetic valve to an autologous valve. The prosthetic valve may include: one or more prosthetic valve leaflets; a valve body that supports the one or more prosthetic valve leaflets and has a proximal portion and a distal portion; one or more hook arm anchors coupled to the valve body, and each hook arm anchor being adapted to hook a leaflet of the autologous valve to anchor to the autologous valve; and one or more support arms coupled to the valve body, and each support arm having a proximal portion coupled to the valve body and a distal portion that projects from the valve body in a distal direction and is configured to extend into the ventricle, the one or more support arms being adapted to stabilize the prosthetic valve within the autologous valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 A perspective view of the prosthetic valve is shown.

[0027] Figure 2 Shows Figure 1 A cross-sectional schematic view of the prosthetic valve shown in

[0028] Figure 3 A perspective view of a barrier layer for a prosthetic valve leaflet is shown.

[0029] Figure 4 Shows a top perspective view of a barrier layer coupled to an inner frame of a prosthetic valve.

[0030] Figure 5A Shows a cross-sectional schematic view of a prosthetic valve deployed at an implantation site.

[0031] Figure 5B Shows a cross-sectional schematic view of a prosthetic valve deployed at an implantation site.

[0032] Figure 6 Shows a cross-sectional schematic view of a prosthetic valve deployed at an implantation site.

[0033] Figure 7A Shows a perspective view of a skirt.

[0034] Figure 7B Shows Figure 7A A side cross-sectional view of the skirt shown in

[0035] Figure 7C Shows Figure 7A A proximal perspective view of a skirt coupled to an outer skirt of a prosthetic valve shown in

[0036] Figure 7D Shows Figure 7A A distal perspective view of a skirt coupled to an outer skirt of a prosthetic valve shown in

[0037] Figure 7E Shows Figure 7A A distal perspective view of a skirt coupled to a frame shown in

[0038] Figure 7F Shows Figure 7A A side cross-sectional view of the wall of the skirt shown in

[0039] Figure 7G Shows a prosthetic valve including Figure 7A A side cross-sectional view of the skirt shown in

[0040] Figure 8 Shows a perspective view of a frame for a prosthetic valve.

[0041] Figure 9 Shows Figure 8 The outer frame separated from the inner frame shown in Figure 8 A perspective view of the outer frame shown in

[0042] Figure 10 Shows Figure 8 The inner frame separated from the outer frame shown in Figure 8 A perspective view of the inner frame shown in

[0043] Figure 11 A perspective view of a prosthetic valve is shown.

[0044] Figure 12 A plan view of a portion of the frame of the prosthetic valve is shown.

[0045] Figure 13 A detailed view of the portion of the frame circled in Figure 12 is shown.

[0046] Figure 14 A side cross-sectional schematic view of the portion of the frame shown in Figure 13 is shown.

[0047] Figure 15 A perspective view of a portion of the frame is shown.

[0048] Figure 16 A side cross-sectional schematic view of the portion of the frame shown in Figure 15 is shown.

[0049] Figure 17 A perspective view of a portion of the frame is shown.

[0050] Figure 18 A side cross-sectional schematic view of the portion of the frame shown in Figure 17 is shown.

[0051] Figure 19 A plan view of a portion of the frame of the prosthetic valve is shown.

[0052] Figure 20 A side cross-sectional view of the prosthetic valve deployed to the implantation site is shown.

[0053] Figure 21A A plan view showing the position of the anchor relative to the grasping feature is shown.

[0054] Figure 21B A side cross-sectional schematic view of the position of the anchor shown in Figure 21A is shown.

[0055] Figure 22A A cross-sectional schematic view of the prosthetic valve deployed to the native valve is shown.

[0056] Figure 22B A cross-sectional schematic view of the prosthetic valve deployed to the native valve shown in Figure 22A is shown.

[0057] Figure 23 A plan view of a portion of the frame of the prosthetic valve is shown.

[0058] Figure 24A A plan view showing the position of the anchor relative to the grasping feature is shown.

[0059] Figure 24B Shows a side cross-sectional view of the position of the anchor shown in Figure 24A the middle.

[0060] Figure 25 Shows a plan view of a part of the frame of the prosthetic valve.

[0061] Figure 26 Shows a perspective view of a part of the frame of the prosthetic valve.

[0062] Figure 27 Shows a perspective view of the anchor positioned relative to the grasping feature.

[0063] Figure 28 Shows a side view of the anchor positioned relative to the grasping feature.

[0064] Figure 29A Shows a side view of the frame including multiple grasping features.

[0065] Figure 29B Shows relative to Figure 29A a side cross-sectional view of the anchor positioned relative to one of the grasping features shown in

[0066] Figure 30A Shows a perspective view of the prosthetic valve.

[0067] Figure 30B Shows relative to Figure 30A a side cross-sectional view of the anchor positioned relative to one of the grasping features of the prosthetic valve shown in

[0068] Figure 31 Shows Figure 30A a side cross-sectional view of the prosthetic valve deployed to the native valve shown in

[0069] Figure 32 Shows a distal perspective view of the prosthetic valve.

[0070] Figure 33 Shows a cross-sectional schematic view of the prosthetic valve deployed to the native valve.

[0071] Figure 34 Shows a cross-sectional schematic view of the prosthetic valve in an undeployed configuration and positioned within a capsule.

[0072] Figure 35 Shows a perspective view of the prosthetic valve deployed from the capsule.

[0073] Figure 36 Shows a side view of the grasping feature on the anchor.

[0074] Figure 37A A side view showing the gripping features on the anchor

[0075] Figure 37B A perspective view showing the gripping features for the anchor

[0076] Figure 37C A perspective view showing the gripping features for the anchor

[0077] Figure 38 A side view showing the gripping features for the anchor

[0078] Figure 39A A perspective view showing the gripping features for the anchor

[0079] Figure 39B A perspective view showing the gripping features for the anchor

[0080] Figure 40A A side view showing the gripping features for the anchor

[0081] Figure 40B A side view showing the gripping features for the anchor

[0082] Figure 41 A side cross-sectional view showing the frame of the prosthetic valve

[0083] Figure 42 A side cross-sectional view showing the prosthetic valve deployed to the implantation site

[0084] Figure 43 A perspective view showing the anchor relative to multiple gripping features

[0085] Figure 44 A perspective view showing the prosthetic valve

[0086] Figure 45 Shows Figure 44 A top view of the prosthetic valve shown in

[0087] Figure 46 Shows the Figure 44 Top perspective view of a pacemaker lead extending through the channel of the prosthetic valve shown in

[0088] Figure 47 Shows Figure 44 A side cross-sectional schematic view of the prosthetic valve deployed to the implantation site shown in

[0089] Figure 48 A side cross-sectional schematic view of the prosthetic valve deployed to the implantation site, where the pacemaker lead passes along one side of the prosthetic valve

[0090] Figure 49 A perspective view of a prosthetic valve is shown.

[0091] Figure 50 Shown is Figure 49 a distal view or outflow end view of the prosthetic valve of

[0092] Figure 51 Shown is Figure 49 a perspective view of the inner frame of the prosthetic valve of

[0093] Figure 52 Shown is Figure 49 a side view of the outer frame of the prosthetic valve of

[0094] Figure 53 Shown is Figure 49 a perspective view of the inner frame of the prosthetic valve of

[0095] Figure 54 Shown is Figure 49 a side schematic cross-sectional view of the prosthetic valve of

[0096] Figure 55 Shown is Figure 49 a side schematic cross-sectional view of a part of the prosthetic valve of

[0097] Figure 56 A perspective view of a frame for a prosthetic valve is shown.

[0098] Figure 57 Shown is Figure 56 a proximal view or inflow end view of the prosthetic valve of

[0099] Figure 58 A perspective view of a prosthetic valve is shown.

[0100] Figure 59 Shown is Figure 58 a side cross-sectional view of the prosthetic valve of

[0101] Figure 60 A side view of a part of the inner frame is shown.

[0102] Figure 61 A perspective view of a part of the inner frame is shown.

[0103] Figure 62 Shown is Figure 60 and 61 a perspective view of the inner frame of the part containing

[0104] Figure 63 Shown is Figure 62 a cross-sectional view of a prosthetic valve using the frame shown in

[0105] Figure 64AShows a proximal view or inflow end view of the frame of a prosthetic valve.

[0106] Figure 64B Shows Figure 64A A perspective view of the frame shown in

[0107] Figure 65 Shows a prosthetic valve using the Figure 64A Frame in a side perspective view.

[0108] Figure 66 Shows a prosthetic valve using the Figure 64A Frame shown in a side cross-sectional schematic view.

[0109] Figure 67 Shows a perspective view of a prosthetic valve.

[0110] Figure 68 Shows Figure 67 A proximal view or inflow end view of the prosthetic valve shown in

[0111] Figure 69 Shows Figure 67 A proximal view or inflow end view of the frame of the prosthetic valve shown in

[0112] Figure 70 Shows the position of the anchor tip relative to the Figure 69 Frame shown in a side view.

[0113] Figure 71 Shows a prosthetic valve using the Figure 69 Frame shown in a side cross-sectional schematic view.

[0114] Figure 72 Shows a side view of the frame of a prosthetic valve.

[0115] Figure 73 Shows a top schematic view of a prosthetic valve using the frame as shown in Figure 72

[0116] Figure 74 Shows Figure 72 A proximal view or inflow end view of the frame shown in

[0117] Figure 75 Shows a side schematic cross-sectional view of a prosthetic valve using the frame as shown in Figure 72

[0118] Figure 76 Shows a top schematic view of a prosthetic valve.

[0119] Figure 77 Shows a perspective view of an inner frame including a snap anchor. ​​

[0120] Figure 78 shows a top schematic view of a prosthetic valve utilizing a frame as shown in Figure 77 .

[0121] Figure 79 shows a perspective view of a prosthetic valve utilizing a frame as shown in Figure 77 .

[0122] Figure 80 shows a plan view of the inner frame as shown in Figure 77 .

[0123] Figure 81 shows a plan view of a snap anchor

[0124] Figure 82 shows a side view of the position of the anchor tip relative to the outer frame

[0125] Figure 83 shows a plan view of a snap anchor

[0126] Figure 84 shows a plan view of a snap anchor

[0127] Figure 85 shows a plan view of a snap anchor

[0128] Figure 86 shows a side schematic cross-sectional view of a prosthetic valve utilizing a frame as shown in Figure 77 .

[0129] Figure 87 shows a side schematic cross-sectional view of a variant of the prosthetic valve as shown in Figure 86 .

[0130] Figure 88 shows a schematic view of the delivery of the prosthetic valve as shown in Figure 86 .

[0131] Figure 89 shows a schematic view of the delivery of the prosthetic valve as shown in Figure 86 .

[0132] Figure 90 shows a schematic view of the delivery of the prosthetic valve as shown in Figure 86 .

[0133] Figure 91 shows a schematic view of the delivery of the prosthetic valve as shown in Figure 86 .

[0134] Figure 92 shows a distal or outflow perspective view of the prosthetic valve

[0135] Figure 93 Shows Figure 92 a side perspective view of a prosthetic valve.

[0136] Figure 94 Shows a plan view of a barb sheet.

[0137] Figure 95 Shows Figure 92 a schematic diagram of the delivery of the prosthetic valve shown in

[0138] Figure 96 Shows Figure 92 a schematic diagram of the delivery of the prosthetic valve shown in

[0139] Figure 97 Shows Figure 92 a schematic diagram of the delivery of a variant of the prosthetic valve shown in

[0140] Figure 98 Shows a side view of a delivery system.

[0141] Figure 99 Shows a schematic diagram of the delivery system approaching the implantation site.

[0142] Figure 100 Shows a schematic diagram of the delivery system approaching the tricuspid valve.

[0143] Figure 101 Shows a schematic diagram of an implant deployed to the tricuspid valve.

[0144] Figure 102 Shows a schematic diagram of an implant deployed to the tricuspid valve.

[0145] Figure 103 Shows a schematic diagram of a tether assembly released from the implant.

[0146] Figure 104 Shows a side view of a prosthetic valve deployed to the tricuspid valve. Detailed Description

[0147] This specification and the accompanying drawings provide aspects and features of the present disclosure in the context of several examples of implants (e.g., prosthetic valves or replacement heart valves) and delivery systems and methods, which are configured for a patient's vasculature, such as for replacing an autologous heart valve within the patient. These examples may be discussed in connection with replacing a particular valve, such as the patient's aortic valve, tricuspid valve, or mitral valve. However, it should be understood that the features and concepts discussed herein can be applied to products other than heart valve implants. For example, the features described herein can be applied to other medical implants, such as other types of prosthetics for other locations within the body (e.g., within an artery, vein, or other body cavity or location). Additionally, specific features of the valves, delivery systems, etc. should not be considered limiting, and the features of any one example discussed herein can be combined with the features of other examples as needed and as appropriate. Although some of the examples described herein are described in connection with a transfemoral delivery method, it should be understood that these examples can be used with other delivery methods, such as a transapical or transjugular method. Moreover, it should be understood that certain features described in connection with some examples can be combined with other examples, including examples described in connection with different delivery methods).

[0148] Figure 1 A perspective view of an implant in the form of a prosthetic valve 10 is shown. The prosthetic valve 10 may include a prosthetic heart valve for deployment to an autologous heart valve of a patient's body. The prosthetic heart valve may replace the function of the autologous heart valve. In an example, other forms of implants and prosthetic valves may be utilized as needed.

[0149] The prosthetic valve 10 may be configured to be deployed to the annulus of the autologous valve, which may include an autologous mitral valve or an autologous tricuspid valve. In an example, other implant locations may be used, such as within the aortic valve or pulmonary valve, or at other valves or locations within the patient's body as needed.

[0150] The prosthetic valve 10 may include a proximal 12 or inlet end portion or upstream end portion and a distal 14 or outlet end portion or downstream end portion (in Figure 2(in the middle mark), and the length between them. The prosthetic valve 10 may also include a valve portion, which is preferably formed by a plurality of prosthetic valve leaflets 16. The valve portion is positioned in a flow channel or passage for controlling the flow through the prosthetic valve 10. The flow channel or passage is formed by the support structure or valve body 15 of the valve 10. The valve body 15 or support structure has a proximal portion or inlet end portion or upstream end portion and a distal portion or outlet end portion or downstream end portion. The prosthetic valve leaflets 16 move between an open state and a closed state to mimic and replace the operation of native valve leaflets. The leaflets 16 allow flow in a first direction and prevent flow in a second direction. The valve portion is positioned within the passage of the valve body 15 to permit blood to flow through the passage in one direction, thereby performing the function of replacing a native heart valve. The prosthetic valve leaflets 16 are made of pericardium, such as bovine pericardium or porcine pericardium, or made of another material as needed. In an alternative arrangement, the leaflets are formed of a synthetic (e.g., polymeric) material, or the valve portion is a mechanical one-way valve.

[0151] The prosthetic valve leaflets 16 may be coupled to the valve body 15 and may extend radially inward from the valve body 15 into the flow channel. The valve body 15 may surround and support the valve portion and one or more prosthetic valve leaflets 16.

[0152] In an example, the valve body 15 may include one or more bodies. The valve body 15 may include, for example, an inner body 18 (in the Figure 2 middle mark) and an outer body 20.

[0153] Figure 2 A cross-sectional schematic view of the prosthetic valve 10 is shown. The inner body 18 may include a proximal portion including a proximal end 22 and a distal portion including a distal end 24. The inner body 18 may have a spherical shape, including a curved body that curves radially outward between the proximal end 22 and the distal end 24, or may have another configuration in an example as needed. In an example, the inner body 18 may have a circular shape. The inner body 18 may support a plurality of prosthetic valve leaflets 16.

[0154] The inner body 18 may include an inner frame 26 (or inner support stent), and the inner frame may include a plurality of struts 28 (shown in the Figure 4 middle) that are spaced apart from each other by a space 30 (shown in the Figure 4 middle). The plurality of struts 28 form an expandable and collapsible unit. Such a configuration may allow the inner frame 26 to move between an un-deployed, un-expanded or linearized configuration and a deployed or expanded configuration. For example, the inner frame 26 may expand radially outward to move to a deployed or expanded configuration, where the length of the inner frame 26 decreases due to an increase in the diameter of the inner frame 26. Other configurations of the inner frame 26 may be utilized as needed.

[0155] The inner frame 26 can include an outer surface 32 or an outward-facing surface, and can include an inner surface 34 or an inward-facing surface (marked in Figure 2 ). The outer surface 32 can face outward from the flow channel 13, and the inner surface 34 can face the flow channel 13. The inner frame 26 supports the prosthetic valve leaflets 16. The prosthetic valve leaflets 16 are positioned inside the frame 26.

[0156] In an example, the inner body 18 can include a skirt 36 (marked in Figure 2 ). In an example, the skirt 36 can be positioned on the outer surface 32 of the inner frame 26, or can be positioned on the inner surface 34 of the inner frame 26 (as marked in Figure 2 ). The skirt 36 can extend along the inner frame 26 from the proximal end 22 of the inner body 18 to the distal end 24 of the inner body 18, or can extend only along a portion of the inner frame 26. The skirt 36 can be configured to impede fluid flow therethrough to impede lateral fluid flow through the flow channel 13 and promote axial flow through the flow channel 13.

[0157] In an example, the skirt 36 can be configured to couple to one or more prosthetic valve leaflets 16. For example, a suture 38 or a stitch between the prosthetic valve leaflet 16 and the skirt 36 can couple the prosthetic valve leaflet 16 to the skirt 36. The suture 38 or the stitch can have a curved or arcuate shape to account for the shape of the prosthetic valve leaflet 16. The outer end portion 40 of the prosthetic valve leaflet 16 (marked in Figure 2 ) can be coupled to the skirt 36, and the opposite inner end portion 42 can be configured to collapse during opening and closing of the prosthetic valve leaflet 16.

[0158] The prosthetic valve leaflets 16 can be coupled to the skirt 36 and can extend radially inward from the skirt 36. The prosthetic valve leaflets 16 can surround the flow channel 13, as marked in Figure 2 , and can move between an open state and a closed state to control the flow through the flow channel 13. The proximal end of the prosthetic valve 10 can include the inflow end of the valve 10, and the distal end of the prosthetic valve 10 can include the outflow end, but other configurations can be utilized as needed. The prosthetic valve leaflets 16 can be positioned about the central axis 43 of the prosthetic valve 10. The inner body 18 and the outer body 20 can each surround the central axis 43 of the prosthetic valve 10.

[0159] The prosthetic valve 10 may include one or more anchor members 44 that may be configured to anchor the prosthetic valve leaflets 16 to a portion of a patient's heart, which portion may include an autologous valve. The anchor member 44 may specifically be configured to anchor to an autologous valve leaflet of the patient's heart. The anchor member 44 may extend around the autologous valve leaflet to anchor to the autologous valve leaflet. The anchor member 44 may include a distal anchor member positioned at the distal end 14 of the valve 10 or, in an example, may be disposed at another location as needed. The anchor member 44 may include a ventricular anchor member that extends from a downstream portion of the frame of the prosthetic heart valve and is shaped to capture an autologous leaflet of the autologous heart valve between the anchor member 44 and the outer surface 64 of the outer frame 48.

[0160] Each anchor member 44 may be configured as a projecting arm that is configured to extend distally and then bend in a proximal direction to the tip of a respective one of the anchor members 44. Such a configuration may allow the anchor member 44 to extend around the autologous leaflet and around the distal tip of the leaflet to hook the distal tip of the autologous valve leaflet and be positioned radially outside the outward-facing surface of the autologous valve leaflet. For example, the anchor member 44 may be configured in a hook-shaped configuration, as Figure 1 and 2 shown. Accordingly, the anchor member 44 may resist forces applied to the valve 10 in the atrial or proximal direction and may anchor the valve 10 within the autologous valve annulus. Other configurations of the anchor member 44 may be utilized in an example as needed.

[0161] The anchor member 44 is shown in Figure 1 and 2 in a deployed or expanded configuration, where the tip of the anchor member 44 extends proximally. In an example, the anchor member 44 may be configured in an undeployed, unexpanded, or linearized configuration, where the tip of the anchor member 44 extends distally. For example, such a configuration is shown in Figure 34 In an example, the anchor member 44 may be configured to be flexible. Once deployed, the anchor member 44 may be configured to move radially outward from the undeployed configuration to the deployed configuration, where the tip flips in the proximal direction. Such an operation may allow the anchor member 44 to flip the autologous valve leaflet to anchor to the autologous valve leaflet during deployment. For example, such a configuration is shown in Figure 5A and 5B Other deployment methods of the anchor member 44 may be utilized in an example as needed.

[0162] The anchor members 44 can each extend radially outward from the flow channel 13 and radially outward from the prosthetic valve leaflets 16 of the valve 10. The anchor members 44 can be configured to extend radially outward from the inner body 18 across the gap 46 between the inner frame 26 and the outer frame 48. The anchor members 44 can extend to the tips of the respective anchor members 44. The anchor members 44 can be coupled to the distal end 24 of the inner body 18 and specifically to the distal end of the inner frame 26. Each of the anchor members 44 can include a proximal portion 50 and a distal portion 52, where the proximal portion 50 is coupled to the inner frame 26 and the distal portion 52 includes the tip of the respective anchor member 44. When the valve 10 is deployed, the anchor members 44 can extend vertically from the proximal portion 50 to the tips at the distal portion 52.

[0163] The valve body 15 can include a sealing body 11. The sealing body 11 can be positioned radially outward from the prosthetic valve leaflets 16 and can be configured to seal against a portion of the native valve. The sealing body 11 can include the outer surface of the prosthetic valve 10. The sealing body 11 can define the outer diameter of the prosthetic valve 10 and can include the outer periphery of the prosthetic valve 10. The sealing body 11 can include a proximal portion having a proximal end 54 and can include a distal portion having a distal end 56 (marked in Figure 2 ).

[0164] In an example, the sealing body 11 can include an outer body 20 positioned radially outside the inner body 18.

[0165] Referring Figure 2 to the cross-sectional view of, the sealing body 11 can include a frame 48 and a sealing skirt 58, or in an example can include only the frame or only the sealing skirt as needed. The frame 48 can include an outer frame (or outer support bracket) positioned radially outward from the inner frame 26.

[0166] The outer frame 48 includes at least a portion of the sealing body 11 that is configured to apply a seal to a portion of the heart. The outer frame 48 can have a proximal portion 60 coupled to the proximal end 22 of the inner body 18. The proximal portion 60 can extend radially outward from the proximal end 22 of the inner body 18 and from the prosthetic valve leaflets 16. The distal portion 62 of the outer frame 48 can be spaced apart from the prosthetic valve leaflets 16 and the inner frame 26 by a gap 46. The gap 46 can be positioned between the outer frame 48 of the sealing body 11 and the distal portion of the inner body 18.

[0167] The outer frame 48 can include an outer surface 64 or an outward-facing surface and can include an inner surface 66 or an inward-facing surface. The outward-facing surface can face outward from the flow channel 13, and the inward-facing surface can face the flow channel 13. The outer surface 64 is for pressing and sealing against the tissue of the native heart valve.

[0168] In an example, the length of the outer frame 48 can extend distally to a distance less than the distal end of the inner frame 26. Thus, the outer frame 48 can be shorter than the inner frame 26. The outer frame 48 can further have a curved configuration that curves outward from the inner frame 26, where the maximum diameter of the outer frame 48 is at the distal portion of the outer frame 48.

[0169] The outer frame 48 of the sealing body 11 can include a plurality of struts 68 that form the frame 48 (as labeled in Figure 1 ), with spaces 70 therebetween. The plurality of struts 68 form expandable and collapsible units. Such a configuration utilized with the frame 48 can allow the frame 48 to move between an undeployed, unexpanded, or linearized configuration and a deployed or expanded configuration, as shown in Figure 1 , where the outer frame 48 and the sealing body 11 have a curved spherical shape. Similar to the inner frame 26, during deployment, as the diameter of the outer frame 48 of the sealing body 11 increases, the length of the outer frame 48 of the sealing body 11 may decrease. In an example, the diameter of the outer frame 48 of the sealing body 11 can expand radially outward from the inner frame 26 simultaneously or at a different expansion time or rate than the inner frame 26. In an example, the outer frame 48 can be more flexible than the inner frame 26 and can be adapted to conform to the shape of the native heart valve. Both the outer frame 48 and the inner frame 26 can be self-expanding and can be made of a shape memory material. In an example, the shape memory material can include nitinol, or can include another material. The self-expanding frame is sized to be deployed within the native heart valve. In an example, other forms of expandable frames (e.g., balloon-expandable or mechanically expandable) can be utilized.

[0170] The sealing body 11 can include a sealing skirt 58, which in an example can be coupled to the outer frame 48 of the sealing body 11 or can be released from the outer frame 48. The sealing skirt 58 can extend along the outer frame 48. The sealing skirt 58 can include a fabric skirt that covers at least a portion of the outer surface 64 of the outer frame 48.

[0171] In an example, the sealing skirt 58 can have a distal portion 72 and a proximal portion 74. The distal portion 72 can extend above the distal portion of the outer frame 48 and can, for example, extend above the outer surface 64 of the outer frame 48. The distal portion 72 can extend proximally to an end 76, which can be located, for example, at the midpoint of the outer frame 48 or at another location as needed. The distal portion 72 can extend distally, for example, by spanning the gap 46 to be coupled to the inner body 18. In an example, the distal portion 72 can be coupled to one or more anchors 44.

[0172] The proximal portion 74 of the sealing skirt 58 may be positioned on the inner surface 66 or inward-facing surface of the outer frame 48. In an example, the proximal portion 74 of the sealing skirt 58 may extend proximally to the proximal end 54 of the sealing body 11.

[0173] The sealing skirt 58 may be made of a material that resists fluid flow therethrough, such as cloth, woven material, or other materials, such as polymers or other materials that resist fluid flow therethrough. The material may include fabric. A variety of materials may be utilized for the skirt 58 as needed.

[0174] The sealing body 11 may be configured to abut a portion of the patient's heart to reduce fluid flow. The skirt 58 may be configured to seal a portion of the native valve annulus. For example, the sealing body 11 may abut the surface of the patient's native valve leaflets to reduce fluid flow between the sealing body 11 and the native leaflets. The sealing body 11 may be configured to abut other portions of the patient's heart as needed to reduce fluid flow.

[0175] The sealing body 11 may be flexible to allow movement and conform to the native valve annulus.

[0176] In an example, at least a portion of the prosthetic valve 10 may comprise a material that can be configured to reduce tissue formation or thrombus formation along a portion of the prosthetic valve 10. The material may have various forms. For example, the material may include a textile configured to reduce tissue formation or thrombus formation of the textile. The textile may be configured to be anticoagulant to reduce the likelihood of thrombus formation. The textile may be configured in other ways to reduce tissue formation or thrombus formation. The material may include a coating on a portion of the prosthetic valve 10. The coating may be anticoagulant or otherwise configured to reduce tissue formation or thrombus formation. The coating may be disposed on the frame, skirt, or another portion of the prosthetic valve 10 as needed. In an example, the material may include the material forming a portion of the prosthetic valve. For example, the frame may be constructed of a material that resists tissue formation or thrombus formation. One or more of the prosthetic valve leaflets may be constructed of a material that resists tissue formation or thrombus formation. Any portion of the prosthetic valve may be configured to resist tissue formation or thrombus formation. In an example, tissue formation may include pannus formation. Other forms of tissue ingrowth may be reduced.

[0177] All or a portion of the skirt may include a material configured to reduce tissue formation or thrombus formation. The skirt may be constructed of a material resistant to tissue formation or thrombus formation (e.g., fabric), or may otherwise be coated with a material resistant to tissue formation or thrombus formation. The skirt may be positioned at various locations. For example, all or a portion of the outer skirt or the sealing skirt 58 may include a material configured to reduce tissue formation or thrombus formation. In an example, all or a portion of the skirt 36 of the inner body 18 may include a material configured to reduce tissue formation or thrombus formation.

[0178] The inner surface 80 of the valve body 15 facing the flow channel 13 may include a portion of the prosthetic valve 10 that may be configured to reduce tissue formation or thrombus formation. The inner surface 80 may face opposite the outer surface 81 of the valve body 15, which may include the outer surface 64 of the outer frame 48 or the outer surface of the sealing skirt 58, and may face outward from the flow channel 13. The inner surface 80 may define the flow channel 13.

[0179] In an example, the end portion of the prosthetic valve 10 may include a portion of the prosthetic valve 10 that may be configured to reduce tissue formation or thrombus formation. For example, the proximal portion 82 of the prosthetic valve 10 may include a portion of the prosthetic valve 10 that may be configured to reduce tissue formation or thrombus formation, but the distal portion 84 of the prosthetic valve 10 may alternatively or in combination be utilized. The proximal portion 82 may include the inflow end of the prosthetic valve 10, and the distal portion 84 may include the outflow end of the prosthetic valve 10, but other configurations may be utilized as needed.

[0180] The portion of the prosthetic valve 10 that may be configured to reduce tissue formation or thrombus formation may include one or more of the proximal portion 86 of the inner surface 80 of the valve body 15 or the proximal portion 88 of the outer surface 81 of the valve body 15. For example, the end portions 86, 88 may be close to each other, as Figure 2 shown. In an example, the end portions 86, 88 may be coupled to each other. For example, referring to Figure 1 , the proximal end of the sealing skirt 58 may be sutured or otherwise coupled to the proximal end of the skirt 36. The skirts 58, 36 may be coupled to each other at the proximal margin 90 of the prosthetic valve 10.

[0181] In an example, the portion of the prosthetic valve 10 configured to reduce tissue formation or thrombus formation may include a barrier that prevents ingrowth of tissue at one or more locations. The one or more locations may be at various locations on the prosthetic valve 10 as needed. For example, referring to Figure 2, all or a portion of the outer skirt 58 or the sealing skirt may include a barrier that inhibits tissue formation or thrombus formation. In an example, all or a portion of the skirt 36 of the inner body 18 may include a barrier that inhibits tissue formation or thrombus formation. As needed, other portions of the prosthetic valve 10 may include a barrier that inhibits tissue formation or thrombus formation.

[0182] In an example, the barrier may be configured to reduce or prevent tissue formation or thrombus formation along the inner surface 80 of the valve body 15 facing the flow channel 13. The inner surface 80 may extend along the flow channel 13. The prosthetic valve leaflets 16 may project radially inward from the inner surface 80.

[0183] All or a portion of the skirt 36 may include a barrier layer that reduces tissue formation or thrombus formation. The barrier layer may be configured to be positioned adjacent to the prosthetic valve leaflets 16.

[0184] The barrier layer may include a strip of material 92. For example, Figure 3 A strip of material 92 including the barrier layer is shown. The strip 92 may have various shapes and may have an arcuate shape as shown in Figure 3 or another shape as needed. The strip 92 may be configured to be coupled to the prosthetic valve leaflets 16. For example, the prosthetic valve leaflets 16 may be coupled to the barrier layer or the strip 92 using sutures 38 or suture threads. The strip 92 may extend proximally from the sutures 38 or suture threads to the proximal portion 94 of the strip 92. The strip 92 may form a portion of the skirt 36 that may be positioned along the inner frame 26 and may line the inner surface 34 of the inner frame 26.

[0185] For example, Figure 4 The position of the strip 92 relative to the inner frame 26 is shown. The strip 92 may be positioned at the proximal portion 86 of the inner surface 80 of the valve body 15 and may extend distally from the proximal portion 86. The prosthetic valve leaflets 16 may be coupled to the barrier layer or the strip 92 and may extend distally from the sutures 38 or suture threads and the barrier layer or the strip 92.

[0186] In an example, the barrier layer or the strip 92 may be coupled to a portion of the sealing skirt 58 of the sealing body 11. The proximal portion 94 of the strip 92 may be coupled to, for example, the proximal portion 74 of the sealing skirt 58. Figure 1 It is shown that the proximal portion 94 of the strip 92 may engage the proximal portion 74 of the sealing skirt 58. Sutures or suture threads may be provided to couple the proximal portion 94 of the strip 92 to the proximal portion 74 of the sealing skirt 58, or other forms of coupling may be utilized in an example.

[0187] In an example, the distal portion 96 of the barrier layer or the strip 92 (marked in Figure 3 ) may be coupled to the skirt 36 (in Figure 2the proximal portion of the remainder 98 of the skirt 36 (as marked). The remainder 98 of the skirt 36 may extend along the flow channel 13 and define the portion distal to the connection with the prosthetic valve leaflets 16. The band 92 and the remainder 98 of the skirt 36 may alternatively or in combination form a sleeve that defines the flow channel 13. In an example, the remainder 98 of the skirt 36 may be excluded, such as as Figure 6 shown in

[0188] The barrier layer or band 92 may be configured to reduce the spread of tissue formation or thrombus formation to one or more prosthetic valve leaflets 16. For example, referring to Figure 5A , the prosthetic valve 10 is shown in an implanted configuration, where the anchor 44 is anchored to the native valve leaflets 99 of the native valve 100. The outer surface 81 of the valve body 15 may contact the native valve leaflets 99 or another portion of the native valve 100.

[0189] Over time, after implantation, tissue formation or thrombus formation may occur along a portion of the prosthetic valve 10. For example, referring to Figure 5B , tissue formation 102 or thrombus formation has occurred along the surface of the prosthetic valve 10, and the tissue formation or thrombus formation may be in the form of pannus growth. For example, the outer surface 81 of the valve body 15 has experienced tissue formation 102. In an example, the tissue formation 102 may be used to implant and further fix the prosthetic valve 10 to the implantation site. However, the barrier layer or band 92 may be used to reduce tissue formation or thrombus formation. The barrier layer or band 92 may impede tissue formation or thrombus formation along the inner surface 80 of the valve body 15 and for the prosthetic valve leaflets 16. For example, the barrier layer or band 92 may impede distal tissue formation or thrombus formation starting from the proximal edge 90 of the prosthetic valve 10. Thus, the likelihood of tissue formation or thrombus formation on the prosthetic valve leaflets 16 can be reduced.

[0190] Such results can beneficially reduce the likelihood of impeding the operation of the prosthetic valve leaflets 16 due to tissue formation or thrombus formation along the prosthetic valve leaflets 16. In addition, due to the reduced likelihood of tissue formation or thrombus formation along the flow channel 13, the flow along the flow channel 13 can be improved. The likelihood of valve stenosis or failure can be reduced.

[0191] In an example, the distal portion 104 of the skirt 36 may be configured to reduce tissue formation or thrombus formation. For example, the distal portion 104 may reduce the likelihood of tissue formation or thrombus formation in the proximal direction towards the prosthetic valve leaflets 16. In an example, and referring to Figure 6 , the remainder 98 of the skirt 36 may be excluded, and the remainder may include the distal portion 104 of the skirt 36, and the band 92 (as Figure 3The (as marked therein) may include an entire barrier layer for the prosthetic valve leaflets 16.

[0192] In an example, other parts of the prosthetic valve 10 may include materials that can be configured to reduce tissue ingrowth along portions of the prosthetic valve 10 as needed. In an example, portions of the prosthetic valve 10 may be configured for tissue ingrowth. For example, the outer surface 81 of the valve body 15 may be configured for tissue ingrowth to seal or anchor to the implantation site. However, another part of the prosthetic valve 10, such as the barrier layer or band 92, or other parts of the prosthetic valve 10, may reduce tissue ingrowth as needed.

[0193] Figure 7A A perspective view of an example in which a skirt 83 may be provided is shown. Unless otherwise stated, the skirt may include features similar to the skirt 36. The skirt 83 may extend from a proximal portion 85 to a distal portion 87. The skirt 83 may include a sleeve configured to be positioned inside the inner frame 26. The skirt 83 may extend along the inner surface 34 or the inward-facing surface of the inner frame 26. The skirt 83 may include multiple material portions sewn or sutured together along a suture line 89.

[0194] One or more of the prosthetic valve leaflets 16 in the prosthetic valve may extend radially inward from the inner surface 91 of the skirt 83. The inner surface 91 may face the flow channel and may face opposite to the outer surface 93 of the skirt 83. One or more of the prosthetic valve leaflets 16 may be coupled to the skirt 83 using sutures or suture lines 95.

[0195] Figure 7B A cross-sectional view of the skirt 83 is shown.

[0196] Reference Figure 7C , the proximal portion 85 of the skirt 83 may be configured to be coupled to the proximal portion 74 of the sealing skirt 58. The proximal portion 85 of the skirt 83 may be coupled to the proximal portion 74 of the sealing skirt 58, for example, along a suture line 97. The connection between the inner skirt 83 and the sealing skirt 58 may include the proximal edge 105 of the prosthetic valve.

[0197] Reference Figure 7D , the distal portion 87 of the skirt 83 may be configured to be coupled to the distal portion 72 of the sealing skirt 58. The distal portion 87 of the skirt 83 may be coupled to the distal portion 72 of the sealing skirt 58, for example, along a suture line 101. The connection between the inner skirt 83 and the sealing skirt 58 may include the distal edge 107 of the prosthetic valve.

[0198] Figure 7E A view of the position of the skirt 83 relative to the inner frame 26 before being coupled to the sealing skirt 58 is shown.

[0199] The skirt 83 can be configured to reduce tissue formation or thrombus formation along the length of the skirt 83. The outer surface or the inner surface of the skirt 83 can be configured to reduce tissue formation or thrombus formation along the length of the skirt 83. The skirt 83 can include a barrier layer for reducing tissue formation or thrombus formation towards the prosthetic valve leaflets 16 and along the flow channel of the prosthetic valve. The distal portion 87 of the skirt 83 and the proximal portion 85 of the skirt 83 can each be configured to reduce tissue formation or thrombus formation in the respective proximal or distal direction towards the leaflets 16. The distal portion 87 of the skirt 83 and the proximal portion 85 of the skirt 83 can each be configured to reduce tissue formation or thrombus formation starting from the respective distal edge 107 or proximal edge 105.

[0200] In an example, the surface of the skirt 83 can include a coating or layer that can reduce tissue formation or thrombus formation. For example, referring to Figure 7F , the inner surface 91 of the skirt 83 can include a coating or layer that can reduce tissue formation or thrombus formation. The inner surface 91 can include a polymer or laminate that can reduce tissue formation or thrombus formation. The outer surface 93 of the skirt 83 can include a textile or other form of material. In an example, both surfaces 91, 93 of the skirt 83 can reduce tissue formation or thrombus formation.

[0201] Figure 7G A prosthetic valve 103 utilizing the skirt 83 is shown. The distal portion 87 of the skirt 83 can be configured to be coupled to the distal portion 72 of the sealing skirt 58. Unless otherwise stated, the prosthetic valve 103 can include the features of the prosthetic valve 10.

[0202] Figure 1 - 7G The features of

[0203] can be utilized alone or in combination with any other examples disclosed herein. Figure 8 A configuration of the frame 110 of a prosthetic valve 112 (marked in Figure 11 ) is shown. Unless otherwise stated, the frame 110 and the prosthetic valve 112 can include the features of the frame and the prosthetic valve 10 discussed with respect to Figure 1 - 7G . The frame 110 can include, for example, an outer frame 114 and an inner frame 116. The outer frame 114 can include a plurality of struts 118 separated by spaces and forming a lattice, similar to Figure 1 the outer frame 48 of Figure 4 . The inner frame 116 can similarly include a plurality of struts 120 separated by spaces and forming a lattice, similar to

[0204] Figure 9 the inner frame 26 ofThe outer frame 114 is shown separated from the inner frame 116. The outer frame 114 can be configured to form a shoulder 121 or a protrusion of the outer surface 122 of the outer frame 114 relative to the distal portion 124 of the outer frame 114. The shoulder 121 can be used to reduce the distal or ventricular movement of the prosthetic valve 112 during implantation.

[0205] Figure 10 The inner frame 116 is shown separated from the outer frame 114. A plurality of arms 126 including anchors can extend radially outward from the distal portion 128 of the inner frame 116.

[0206] Figure 11 A perspective view of the prosthetic valve 112 is shown, where one or more skirts are applied to the frames 114, 116. The prosthetic valve leaflets 129 are positioned within the flow channel of the prosthetic valve 112; The features of the prosthetic valve 112 can be utilized with any of the examples disclosed herein.

[0207] In an example, at least a portion of the prosthetic valve can include a frame having a rough surface. Refer to Figure 12 , for example, a portion of the frame 130 can include a rough surface 132. The portion of the frame 130 can include struts 134a-d, which can be constructed and utilized in a manner similar to other frames disclosed herein. The rough surface 132 can include all or a portion of the frame 130.

[0208] In an example, the rough surface 132 can be positioned on the outer surface 136 of the frame 130. For example, the outer surface 136 can be configured to contact a portion of the native valve, such as a native valve leaflet or annulus or other portion. The rough surface 132 can be configured to provide friction with a portion of the native valve. This friction can be used to improve the anchoring with the portion of the native valve. In an example, the frame 130 can include an outer frame or portion of the sealing body of the prosthetic valve for forming a seal with the native valve. The outer frame or portion of the sealing body can be configured to contact a portion of the native valve. For example, refer to Figure 1 , the proximal portion of the outer frame 48 is exposed and can contact a portion of the native valve. Refer to Figure 11 , the proximal portion of the outer frame 114 can be similarly exposed and can contact a portion of the native valve. In an example, the rough surface 132 can be positioned at the distal portion of the outer frame and can be configured to contact a portion of the native valve.

[0209] In an example, other portions of the frame may include a rough surface. For example, one or more of the anchor members (e.g., the distal anchor member) may include a rough surface. Such a surface may increase friction with one or more of the native valve leaflets to improve anchoring. All or a portion of the inner frame may include a rough surface. Such a surface may be used to couple to a prosthetic valve leaflet or to provide another function.

[0210] The rough surface may have various forms. In an example, the rough surface may include a pattern of protrusions extending from the surface of the frame 130. In an example, the rough surface may include one or more voids in the surface of the frame 130 (e.g., as Figure 17 and 18 shown).

[0211] In an example, the portion 138 of the frame 130 adjacent to the rough surface 132 may be smooth. One or more rough surfaces 132 may be selectively positioned on portions of the frame 130 to provide a desired configuration of the rough surface 132. One or more smooth portions 138 may be positioned adjacent as needed.

[0212] In an example, the smooth portion 138 may include a polished surface of the frame 130. The rough surface 132 may include an unpolished surface that forms the surface roughness. The polishing may occur during the formation process of the frame 130. Regions of the frame 130 may be selectively polished to form portions of the frame having surface roughness and smooth portions.

[0213] In an example, the rough surface 132 may include residues from the formation process of the frame. For example, when the frame is formed, surface residues may be produced that are typically removable before using the frame. However, the surface residues may be retained and may not be polished in one or more regions to remain on the surface of the frame. In an example, the frame may be made of a shape memory material (e.g., nitinol or another form of shape memory material), and the surface residues may be present on the shape memory material. The rough surface may include an unpolished surface roughness of nitinol.

[0214] In an example, the pattern of the rough surface 132 may be irregular. For example, Figure 13 shows a close-up view of the rough surface 132 having an irregular pattern. The irregular pattern may be produced by an irregular nature, where the rough surface 132 includes residues from the formation process. Figure 14 shows Figure 13 a side view of the rough surface 132 shown in

[0215] In an example, the rough surface can be formed in a variety of other ways, such as sputtering or depositing particulate matter on the frame, or forming the rough surface by physical abrasion of the frame.

[0216] In an example, a micro-structure can be formed on the frame. For example, Figure 15 A micro-structure 142 with a regular pattern formed on the frame is shown. The micro-structure can be configured to produce van der Waals force interactions to provide adhesion to the implantation site. Figure 16 A side view of the micro-structure 142 is shown. Due to the regular pattern, other forms of friction can be provided. The micro-structure 142 can have various forms, including circular, square, dot, triangular or other forms.

[0217] In an example, the rough surface can include one or more voids 144 in the surface of the frame. For example, Figure 17 A plurality of voids 144 are shown, where Figure 18 A cross-sectional side view of the void 144 is provided. The void 144 can be irregular or regular in configuration. The void 144 can be formed in a variety of ways, including chemical erosion or physical impact on the frame surface.

[0218] In an example, the rough surface can be used to rub against a portion of the native valve. The rough surface can improve the anchoring or fixation of the prosthetic valve to the implantation site. In an example, the rough surface can be used for tissue ingrowth. For example, the rough surface can provide improved tissue growth as needed for adhesion and sealing. It may cause tissue formation or thrombus formation. For example, a series of voids 144 or a series of protrusions can provide improved tissue growth. In an example, the rough surface can be used for other purposes.

[0219] Figure 12 - 18 The features can be utilized individually or in combination with any other examples disclosed herein.

[0220] In an example, the valve body can include one or more grasping features configured to be positioned radially medial to one or more of the native valve leaflets. One or more anchors can be configured to be positioned radially lateral to one or more of the native valve leaflets and press one or more of the native valve leaflets toward the one or more grasping features to reduce movement of one or more of the native valve leaflets relative to the valve body. The anchor can press the native valve leaflet against the grasping feature to fix the prosthetic heart valve within the native heart valve.

[0221] For example, referring to Figure 19 , the frame 150 of the sealing body is shown in a flat pattern. Unless otherwise specified, the frame 150 can include Figure 9the features of the outer frame 114 shown in, or may include Figure 1 the features of the outer frame 48 shown in. The frame 150 may include a portion of the seal body for forming a seal with the native valve, or may be otherwise configured. The frame 150 may include the outer frame of a multi-frame prosthetic valve, or may be used in a single-frame embodiment.

[0222] The frame 150 may include a plurality of struts 152 and openings 154, 155 between the struts, similar to other frames disclosed herein.

[0223] In an example, one or more grasping features 156 may be provided. The grasping features 156 may have various forms. For example, referring to Figure 19 , the grasping features 156 may include one or more protrusions extending from the frame 150. Each protrusion may extend distally, for example. Other directions of the protrusions may be utilized in an example.

[0224] In an example, the protrusions may be positioned circumferentially aligned with the anchors of the prosthetic valve. For example, referring to FIG. 21, the anchor 158 is shown aligned with the grasping feature 156, where the tip 168 of the anchor 158 is positioned at the grasping feature 156. Other positions of the grasping feature may be utilized in an example.

[0225] Referring to Figure 19 , in an example, the grasping feature 156 may extend distally toward an opening 154 circumferentially alignable with the anchor 158. The opening 154 may be positioned between adjacent struts 160 that may extend distally from the grasping feature 156. The adjacent struts 160 may extend distally to the apex 162 of the struts 160, which may include the most distal portion of the frame 150. The grasping feature 156 may be positioned at the proximal portion of the struts 160.

[0226] The grasping features 156 may each include a sharp tip and may include barbs or hooks in an example. In an example, the grasping features 156 may have other configurations.

[0227] The anchor 158 may be configured to press one or more native valve leaflets toward one or more grasping features to reduce movement of one or more of the native valve leaflets relative to the valve body. The anchor 158 may be configured to clamp with one or more grasping features. The anchor 158 may be biased to apply an inward force to the leaflets to press the leaflets toward the grasping features. The grasping features or the valve body may be biased to apply an outward force to the leaflets so that the anchor 158 presses the leaflets toward the grasping features. In an example, the anchor and the valve body may not be biased, but may be sized and positioned relative to each other so that the anchor presses one or more native valve leaflets toward one or more grasping features. For example,Figure 20 Illustrated is a configuration of the valve body 161 and the anchor 164 without using the grasping feature. The native valve leaflets 99 may slide proximally relative to the valve body 161 after implantation. For example, the native valve 100 may expand or otherwise alter the configuration of the native valve leaflets 99 or the native valve 100. The valve body 161 may slide distally (represented by arrow 166), which may be undesirable. An anchor 158 configured to press one or more native valve leaflets toward one or more grasping features to reduce the movement of one or more of the native valve leaflets relative to the valve body may beneficially reduce the likelihood of such axial movement of one or more of the native valve leaflets relative to the valve body. The distal and ventricular movement of the prosthetic valve can be resisted. Adverse outcomes caused by dynamic fluctuations (e.g., dilation) in the valve anatomy can be reduced.

[0228] Figure 21A A plan view showing the position of the anchor 158 relative to the grasping feature 156 is illustrated. The anchor 158 may include a tip 168 that can be aligned with the position of the grasping feature 156. The tip 168 of the anchor 158 may be in the same circumferential position as the grasping feature 156 and may be in the same axial position or height as the grasping feature 156. Thus, the native valve leaflets can be pressed between the grasping feature 156 and the tip 168 of the anchor 158.

[0229] For example, Figure 21B Illustrated is Figure 21A a side cross-sectional view of the configuration shown in. The tip 168 is positioned to press the native valve leaflets in the space 170 between the tip 168 and the grasping feature 156.

[0230] In an example, the anchor 158 may be configured to press the native valve leaflets toward the grasping feature 156 to deflect the native valve leaflets between the grasping feature 156 and the anchor 158. For example, the anchor 158 and the grasping feature 156 may be positioned such that the leaflets can deflect radially inward toward the region 172 radially inward of the grasping feature 156 and the anchor 158. Such deflection can further enhance the grasping of the native valve leaflets.

[0231] In an example, a portion of the anchor 158 may include a recess configured to receive the grasping feature 156. Referring to Figure 21B , for example, the tip 168 of the anchor 158 includes a recess 174 in the form of a contoured surface of the tip 168. The contoured surface can conform to the shape of the grasping feature 156 and can contribute to the radial inward deflection of the native valve leaflets. Other configurations of the anchor 158 and the grasping feature 156 may be provided in an example.

[0232] Figure 22A and 22B shows an exemplary deployment of a prosthetic valve including a grasping feature 156 and an anchor 158. For example, referring to Figure 22A , the anchor 158 is shown deployed to the native valve 100, where the tip 168 of the anchor 158 is positioned radially outside the native valve leaflet 99. The frame 150 can expand radially outward and approach the native valve leaflet 99. For example, the retaining body of the capsule 176 can be retracted to allow the frame 150 to expand.

[0233] Figure 22B Shows the expanded frame 150. The anchor 158 presses one or more native valve leaflets 99 against one or more grasping features 156 to reduce movement of one or more of the native valve leaflets 99 relative to the valve body 178. The likelihood of distal or ventricular movement of the valve body 178 relative to the native valve leaflets 99 can be reduced. The native valve leaflets 99 are further shown deflected between the grasping feature 156 and the anchor 158.

[0234] In an example, the configuration of the grasping feature or the anchor can vary as needed. For example, referring to Figure 23 , the grasping feature 180 can include the surface roughness of the frame. The surface roughness can be formed in various ways as needed. The grasping feature 180 can include protrusions on which the surface roughness can be located. The protrusions can be located in positions similar to those of the grasping feature 156 shown in Figure 19 , or can be arranged in different positions as needed. The grasping feature 180 can be aligned with the anchor 184 (labeled in Figure 19 ) in a manner similar to the grasping feature 156 shown in Figure 24A . For example, Figure 24A shows the alignment of the grasping feature 180 with the tip 182 of the anchor 184.

[0235] Figure 24B Shows a side cross-sectional view of the position of the grasping feature 180 relative to the anchor 184. The grasping feature 180 contacts the native valve leaflet 99 to provide friction with the native valve leaflet 99. The grasping feature 180 and the anchor 184 clamp.

[0236] Other forms of grasping features or anchors can be provided in an example. For example, Figure 25An example is shown in which one or more grasping features 186 are positioned on the longitudinally extending struts 160 of the frame 151. The grasping features 186 are disposed along the outer surface of the frame 151. The struts 160 define openings 154 that are circumferentially aligned with the anchor. The grasping features 186 include protrusions that extend laterally inwardly toward the openings 154. The protrusions may include tips or barbs. A plurality of grasping features 186 may extend laterally inwardly toward a respective one of the openings 154. Other positions, such as extending from the apex of the strut 160, may be utilized. In an example, the grasping features may be arranged asymmetrically. The grasping features may point distally or in the outflow or distal direction, or may point proximally or in the inflow or proximal direction. In an example, the grasping features may flare radially outward. In an example, the grasping features may be positioned only along the downstream, outflow, or distal portion of the frame 151, as Figure 25 shown. In an example, the grasping features may be positioned along the entire outer frame.

[0237] The anchor 190 may be circumferentially aligned with the opening 154. For example, Figure 26 An example of the position of the anchor 190 relative to the opening 154 of the frame 151 is shown. The tip 192 of the anchor 190 is shown as being circumferentially aligned with the opening 154 of the frame 151. Figure 27 A perspective view of the anchor 190 relative to the grasping features 186 is shown.

[0238] The grasping features disclosed herein may project from the skirt or other material of the prosthetic valve. For example, as Figure 27 shown, the grasping features 186 project from or extend through the sealing skirt 194 of the prosthetic valve. In an example, the grasping features may project from the skirt or may be covered by the skirt as needed.

[0239] In an example, the position of the grasping features may vary such that the grasping features are positioned offset from the position of the anchor. For example, Figure 28 A variant is shown in which the grasping features 186 are circumferentially offset from the anchor 190. The circumferential offset may be increased as needed from the Figure 27 configuration shown. The anchor 190 may be configured to clamp with one or more grasping features that are circumferentially offset from the position of the anchor 190.

[0240] Figure 29A and 29BAn example is shown in which the anchor 171 can be positioned at the same radial distance as the grasping feature 173 when clamped with the grasping feature 173. The tip of the anchor 171 can be positioned distal to the grasping feature 173. The anchor 171 can press against the native valve leaflet 99 toward the grasping feature 173 to reduce movement of the native valve leaflet 99 relative to the valve body. The anchor 171 can deflect the native valve leaflet 99 radially inward, as Figure 29B shown.

[0241] The grasping feature 173 can be positioned on a strut of the frame 175, for example, as Figure 29A shown. The grasping feature 173 can be positioned in a manner similar to the grasping features shown in Figure 25 –28. In an example, the grasping feature 173 can be positioned at other locations or can have other configurations.

[0242] Figure 30A and 30B An example is shown in which the anchor 177 can be positioned radially medial to the grasping feature 179. The tip of the anchor 177 can be positioned distal to the grasping feature 179. The anchor 177 can press against the native valve leaflet 99 toward the grasping feature 179 to reduce movement of the native valve leaflet 99 relative to the valve body. The anchor 177 can deflect the native valve leaflet 99 radially inward, as Figure 30B shown.

[0243] The grasping feature 179 can be positioned on a strut of the frame and can project distally, for example, as Figure 30A shown. The grasping feature 179 can be positioned in a manner similar to the grasping features shown in Figure 25 –28. In an example, the grasping feature 179 can be positioned at other locations or can have other configurations.

[0244] In an example, the use of the grasping feature can allow a prosthetic valve to be coupled to a native valve. For example, Figure 31 an example is shown in which clamping between the anchor 177 and the grasping feature 179 can anchor the prosthetic valve 181 to the native valve. The native valve leaflet 99 can be fixed to the prosthetic valve 181.

[0245] Using the grasping feature can allow the outer diameter of the prosthetic valve 181 to be reduced. The outer diameter of the valve body 183 can be reduced. For example, the outer diameter of the valve body 183 can be smaller than the diameter of the annulus of the native valve. Thus, the outer surface of the valve body 183 can be spaced apart from the diameter of the annulus of the native valve. However, the coupling of the prosthetic valve 181 to the leaflets 99 can anchor the prosthetic valve 181 relative to the native valve in place. The leaflets 99 can extend radially inwardly into the prosthetic valve 181 to reduce fluid flow outside the flow channel 185 of the prosthetic valve 181.

[0246] Using a valve body 183 having an outer surface spaced apart from the annulus can reduce the likelihood of conduction disorders and other undesirable conditions that may be caused by the prosthetic valve 181. The position of the anchor 177 can further reduce the outward or radial pressure on the native valve annulus, which can reduce the likelihood of conduction disorders. The native valve may also be able to reduce in diameter or remodel over time after implantation of the prosthetic valve 181.

[0247] In an example, if desired, the examples of the grasping feature disclosed herein can be disengaged. For example, a retraction or recapture procedure applied to the prosthetic valve can release one or more anchors from the grasping feature to allow release of the grasping feature. The prosthetic valve can be repositioned to a desired location, and the grasping feature can be re-engaged as needed.

[0248] Other variations of the configuration of the grasping feature and the anchor can be utilized.

[0249] Figure 19 - 31 The features can be utilized individually or in combination with any other examples disclosed herein.

[0250] In an example, one or more grasping features can be utilized, and the one or more grasping features can be configured to engage the surface of the native valve when one of the anchors fails to capture one or more native valve leaflets. Referring Figure 32 , a distal perspective view of a prosthetic valve 200 incorporating such a grasping feature is shown. The grasping feature can be provided in various positions as needed.

[0251] For example, referring Figure 32 , one or more anchors 202 of the prosthetic valve 200 can include a grasping feature 204. The grasping feature 204 can be positioned on the arm portion 206 of the corresponding anchor 202 or on another portion of the anchor 202 as needed. The grasping feature 204 can be positioned on a portion of the anchor 202 configured to face radially outward. Other positions of the grasping feature 204 can be provided in an example.

[0252] The grasping feature 204 may include a distally extending projection or tip. For example, each grasping feature 204 may include a coupling portion 208 for coupling to the anchor 202 and a distally extending projection 210. In an example, the projection 210 may have an angled tip or other configuration. The coupling portion 208 may include an arm that can be sutured or otherwise coupled to the anchor 202. The projection 210 may be coupled to the coupling portion 208 using a bend or other structure.

[0253] Figure 33 An exemplary deployment of the prosthetic valve 200 is shown. The anchor 202b has captured the native valve leaflet 99b. Accordingly, the tip 212b of the anchor 202b is positioned radially outside of the native valve leaflet 99b, and the grasping feature 204b (similarly configured to the grasping feature 204) is positioned radially outside of the captured native valve leaflet 99b. Accordingly, the grasping feature 204b does not engage the leaflet 99b because the grasping feature 204b faces radially outward.

[0254] Reference Figure 33 On the right side of, the anchor 202a failed to capture the leaflet 99a. Accordingly, the grasping feature 204a (similarly configured to the grasping feature 204) engages the surface of the native valve leaflet 99a when the anchor 202a fails to capture the native valve leaflet 99a. Since the grasping feature 204a is radially outwardly oriented, the grasping feature 204a may penetrate the radially inwardly facing surface of the native valve leaflet 99a. The anchor 202a is positioned radially medial to the native valve leaflet 99a. The resistance of the grasping feature 204a to a force in the distal direction may be greater than the resistance to a force in the proximal direction. Accordingly, once implanted, blood pressure or other forces distal to the prosthetic valve 200 may seat and engage the grasping feature 204a against the leaflet 99a. Accordingly, the grasping feature 204a can be used to anchor the anchor 202a to the leaflet 99a, but the anchor 202a failed to capture the leaflet 99a.

[0255] In an example, the grasping feature 204 may be configured to face radially inward when the anchor 202 is in an undeployed configuration. For example, [[ID=2 The anchors 202a, 202b in an undeployed configuration within, for example, a capsule 176 or other retention member are shown. The anchors 202a, 202ab may be elongate or linearized and may extend distally. The grasping features 204a, 204b may face radially inward. Accordingly, the likelihood of hooking or catching the inner surface of the capsule 176 or other part of the delivery system may be reduced. Once deployed, the capsule 176 may be retracted to allow the anchors 202 to extend radially outwardly and invert from the ​ position shown.

[0256] For example, ​It is shown that the capsule 176 retracts to allow the anchor 202 to expand radially outward. The grasping feature 204 is shown facing radially inward to reduce the likelihood of hooking or snagging the inner surface of the capsule 176 or other parts of the delivery system. The anchor 202 can be bent and reversed in orientation during deployment such that the grasping feature 204 faces radially outward as needed (e.g., as shown in ​ ).

[0257] The configuration of the grasping feature 204 can vary as needed. For example, ​ a configuration is shown in which the grasping feature 212 includes protrusions having distal portions 214 that bend radially outward to extend to a distal tip 216, the distal tip being positioned radially outside the anchor 202.

[0258] ​ –C shows a configuration of a grasping feature 220 including a strip of material having incisions to form a plurality of protrusions 222 when the strip of material is bent. ​ The strip of material in a flat configuration is shown. ​ The strip of material in a bent state is shown, where the protrusions 222 extend outward. The material can be bent over the arms of the anchor 202, as shown in ​ , to cause the protrusions 222 to extend radially outward.

[0259] ​ A configuration of a grasping feature 224 including a strip having laterally extending protrusions 226 is shown. The strip can be applied to the arms of the anchor 202 such that the protrusions 226 engage the surface of the native valve.

[0260] ​ and 39B A configuration of a grasping feature 228 including a tube 230 is shown. The tube 230 can include a plurality of incisions, where edges 232 are configured to grasp a portion of the native valve when the tube 230 is deflected. For example, ​ a deflected tube 230 is shown, where the edges 232 are exposed. In an example, the outer surface of the anchor can be made of the tube 230, where the edges 232 are exposed for engaging the surface of the native valve. The tube 230 can be deflected to expose the edges 232.

[0261] ​ and 40B A configuration of a grasping feature 234 including one or more filaments 236 or wires is shown. The filaments 236 or wires can project radially outward from the anchor 202 and can be configured to be deflectable and smooth when sliding proximally along the native valve leaflet 99a and to be rigid and engage the native valve leaflet 99a when sliding distally along the native valve leaflet 99a. For example, ​Illustrated is a filament 236 that engages a leaflet 99a when a distal force is applied to the anchor 202. In such a configuration, the grasping feature 234 can slide proximally to be placed in a desired position relative to the leaflet 99a, and then a distal force can be applied to the anchor 202 to allow the grasping feature 234 to engage the leaflet 99a. The grasping feature 234 can be positioned as needed on the tip of the anchor or on the curved or lower loop portion of the anchor.

[0262] Other configurations of the grasping feature can be utilized in an example. For example, referring to ​ , one or more grasping features 240 can be positioned on the valve body 242. The grasping feature 240 can include a pointed tip that can extend from the outer frame 244 of the valve body 242. The grasping feature 240 can be positioned in various positions as needed. For example, the grasping feature 240 can be positioned at the distal apex 246 of the strut 248 of the frame 244. The distal apex 246 can include the outflow apex of the frame 244. Other positions can be utilized as needed.

[0263] In an example, the grasping feature 240 can be configured to project radially outward from the valve body 242 to a greater radial distance than the anchor 202. For example, ​ illustrated is that the outer frame 244 or the distal apex 246 of the valve body 242 can project more radially outward than the anchor 202. The grasping feature 240 projects more radially outward than the anchor 202. Thus, when the anchor fails to capture the leaflet, the grasping feature 240 projects radially outward to engage the missed leaflet.

[0264] For example, ​ illustrated is the use of a radially outward projecting grasping feature 240a (constructed similarly to the grasping feature 240) to engage the leaflet 99a that the anchor 202a failed to capture. The grasping feature 240a can penetrate the inward facing surface of the leaflet 99a to engage the leaflet 99a. Referring to the left side of ​ , the grasping feature 240b is positioned to engage the leaflet 99b, but the anchor 202b has captured the leaflet 99b.

[0265] The grasping feature 240 can be deployed in the manner shown in ​ . The anchors 202a, 202b can be deployed. The anchor 202b has captured the leaflet 99b. The anchor 202a has failed to capture the leaflet 99a. The grasping features 240a, 240b can be deployed to expand radially outward. The grasping feature 240a can engage the leaflet 99a to fix and anchor to the leaflet 99a. If needed, the grasping features 240a, 240ab can be retracted radially inward during a re-capture procedure.

[0266] ​The deployment sequence shown in FIG. illustrates the use of the grasping features 204a, 204b. However, in an example, the use of the grasping features 204a, 204b can be excluded, and the grasping features 240a, 240b can include the only means of providing anchoring in the case of missing the capture of the leaflets. In an example, the grasping features 204a, 204b can include the only means of providing anchoring in the case of missing the capture of the leaflets. The grasping feature 204 can be utilized only in combination with the grasping feature 240, and the grasping feature 240 can similarly be utilized alone or in combination with the grasping feature 204.

[0267] In the undeployed configuration as shown in ​ FIG., the grasping features 204a, 204b can extend distally such that the grasping features 204a, 204b do not contact the inner surface of the capsule or other parts of the delivery system.

[0268] In an example, a combination of features can be provided. For example, ​ FIG. shows the grasping feature 204 on the anchor 202 being used in combination with the grasping feature 240 on the valve body. The grasping feature 186 as disclosed with respect to ​ can be further utilized.

[0269] Combinations of features between examples can be utilized.

[0270] ​ The features of

[0271] can be utilized alone or in combination with any other example disclosed herein. ​ In an example, the prosthetic valve can include a valve body having an outer surface, and the outer surface of the valve body can include a channel for a pacemaker lead to pass through. For example, referring to

[0272] FIG., a perspective view of the prosthetic valve 250 is shown. Unless otherwise stated, the prosthetic valve 250 can include features similar to other prosthetic valves disclosed herein.

[0273] The prosthetic valve 250 can include a valve body 252 having an outer surface 254. The outer surface 254 of the valve body 252 can include a surface configured to contact the native valve. In an example, the outer surface 254 can include a sealing surface configured to form a seal with the native valve. For example, the outer surface 254 can include an outer surface of a sealing body configured to form a seal with the native valve.

[0274] Channel 256 can be positioned between struts 258 of the frame 260 of the valve body 252. The struts 258 can be separated, for example, by an opening, similar to other instances of the frame disclosed herein. In an instance, channel 256 can extend through one of the openings. Channel 256 can include a recess in a skirt 262 that can be positioned on the frame 260. The skirt 262 can include, for example, a sealing skirt configured to form a seal with the native valve. Due to the absence of struts 258, the position of channel 256 between the struts 258 of the frame 260 can allow the skirt 262 to be recessed at channel 256. Channel 256 can include a recess in the outer surface 254 of the valve body 252 and the skirt 262. The skirt 262 can be configured to deflect inwardly to form channel 256. The deflection can occur when the pacemaker lead passes between the outer surface 254 of the valve body 252 and the inner surface of the native valve (e.g., the valve annulus).

[0275] In an instance, the proximal surface 264 of the skirt 262 can include a tapered surface. The tapering of the proximal surface 264 can allow the pacemaker lead to more easily extend toward channel 256 when inserted distally toward the prosthetic valve 250. The taper of the surface can include a guiding feature for guiding the pacemaker lead to channel 256.

[0276] ​ A top view of the prosthetic valve 250 is shown, demonstrating the recess of, for example, channel 256.

[0277] The prosthetic valve 250 can be implanted at an implantation site. Once implanted, the outer surface 254 of the valve body 252 can contact the native valve. The pacemaker lead 265 can be inserted adjacent to the prosthetic valve 250 during the implantation procedure or during a subsequent procedure. For example, ​ An implanted prosthetic valve 250 is shown, where the outer surface 254 of the valve body 252 is positioned against the native valve. Channel 256 can be positioned to allow the pacemaker lead 265 to pass through and extend distally or to the ventricular side of the prosthetic valve 250. Channel 256 is positioned between the outer surface 254 of the valve body 252 and the inner surface 266 of the native valve. The outer surface 254 of the valve body 252 and the inner surface 266 of the native valve can form a seal around the pacemaker lead extending through channel 256.

[0278] ​ A side cross-sectional schematic view of the prosthetic valve 250 implanted in the native valve 100 is shown. The pacemaker lead 265 is shown passing through channel 256 and between the outer surface 254 of the valve body 252 and the inner surface 266 of the native valve. The pacemaker lead 265 can beneficially not pass through the central flow channel of the prosthetic valve, as such positioning may impede the operation of the prosthetic valve leaflets.

[0279] ​ A side schematic view shows a pacemaker lead 265 passing through a channel 256 to the distal or ventricular side of a prosthetic valve 250. A distal portion 268 of the pacemaker lead 265 can be implanted at a desired location within the ventricle. A proximal portion 269 of the pacemaker lead 265 can be coupled to a pacemaker. The pacemaker lead 265 can be positioned within the channel 256, which can be circumferentially positioned between two of a plurality of anchors 271. A location between adjacent anchors 271 can assist in securing the pacemaker lead 265 in a position adjacent to the prosthetic valve 250. A location between adjacent anchors 271 can seal the pacemaker lead 265 extending through the channel 256.

[0280] In an example, ​ one or more grasping features of can be utilized with the prosthetic valve 250. The grasping features can assist in securing the prosthetic valve 250 in place as the pacemaker lead advances distally through the channel 256.

[0281] ​ The features of can be utilized alone or in combination with any other example disclosed herein.

[0282] ​ A perspective view shows a prosthetic valve 280 that can be used in any example herein. Unless otherwise noted, the prosthetic valve 280 can include features discussed with respect to the prosthetic valve 10, the prosthetic valve 112, or the prosthetic valve 250. The prosthetic valve 280 can include features of any other prosthetic valve or example disclosed herein.

[0283] The prosthetic valve 280 includes one or more prosthetic valve leaflets 282 (labeled in ​ that can be similarly constructed to the prosthetic valve leaflets 16 disclosed with respect to ​ . The prosthetic valve leaflets 282 can be positioned within a flow channel 284 (labeled in ​ ) of the prosthetic valve 280. The prosthetic valve leaflets 282 are supported by a valve body 286 and can extend radially inward from the valve body 286 within the flow channel 284.

[0284] The valve body 286 can include an inner body 288 (labeled in ​ ) and an outer body 290. Unless otherwise noted, the inner body 288 can include features of other examples of inner bodies disclosed herein. The inner body 288 can include an inner frame 292 (labeled in ​ , 53 and 54). The inner frame 292 supports the prosthetic valve leaflets 282. Refer to ​, the inner frame 292 may include a plurality of struts 294, and the plurality of struts may be separated by spaces or openings 296 in a manner similar to other instances of the inner frames disclosed herein. The inner frame 292 may include a proximal portion 298 and a distal portion 300. The inner frame 292 may include one or more connectors 299 for coupling to the outer body 290. The one or more connectors 299 may be located at the proximal end 301 of the inner frame 292 or at another location as needed.

[0285] In an example, the inner frame 292 may have a proximal portion 298 that is wider than the central portion 302 of the inner frame 292, and a distal portion 300 that is wider than the central portion 302 of the inner frame 292. The inner frame 292 may curve outward from the central portion 302 to the wider proximal portion 298, and may curve outward from the central portion 302 to the wider distal portion 300. For example, the inner frame 292 may have a substantially hourglass shape or profile, which may be similar to ​ the shape or profile of the inner frame 116 shown in. The distal portion 300 of the inner frame 292 may be coupled to the anchor 304.

[0286] Unless otherwise specified, the outer body 290 may include the features of other instances of the outer bodies disclosed herein. The outer body 290 may include a sealed body, and may include an outer frame 306 (labeled in ​ ), and a sealing skirt 308, an outer skirt or a fabric skirt positioned on the outer frame 306. The outer frame 306 may be positioned radially outside the inner frame 292. The outer surface 307 of the outer frame 306 faces radially outward from the prosthetic valve 280. The outer surface 307 is for pressing against the tissue of the native heart valve. The sealing skirt 308 extends along the outer surface 307 of the outer frame 306.

[0287] ​Shows an outer frame 306 isolated from other features of the prosthetic valve 280. The outer frame 306 may include a plurality of struts 310, and the plurality of struts may be separated by spaces or openings 312 in a manner similar to other examples of outer frames disclosed herein. The struts 310 may form openings 312 between the struts 310. The struts 310 may form expandable and collapsible units. The outer frame 306 may include a proximal portion 314 and a distal portion 316. The proximal portion 314 may include a coupling portion having one or more couplers 318 adapted to couple with the inner frame 292 and specifically with the coupler 299 of the inner frame 292. In an example, the coupler 318 may include an eyelet that may be disposed along the proximal inflow end portion or upstream portion of the frame 306 for receiving a suture. The prosthetic heart valve may be deployed by being coupled to a suture (e.g., a tether assembly), where tension is released in the suture to deploy the valve. After deployment, the prosthetic heart valve may be retrieved by applying tension to the suture.

[0288] The proximal portion 314 of the outer frame 306 may be coupled to the proximal portion 298 of the inner frame 292. The outer frame 306 may project radially outward from the coupling portion to a first tapered portion 320. The first tapered portion 320 may extend radially outward from the coupling portion and taper at a first angle (where the angle is more clearly shown in ​ and 55 ). The first tapered portion 320 may extend radially outward to a curved portion or bend portion or intermediate portion 322.

[0289] The curved portion or bend portion or intermediate portion 322 may include a bend or kink that angles the first tapered portion 320 relative to the second tapered portion 324. The intermediate portion 322 may angle the first tapered portion 320 relative to the second tapered portion 324 such that the second tapered portion 324 extends axially. The angle of the intermediate portion 322 may be, for example, seventy degrees or may be a greater angle (e.g., eighty degrees, ninety degrees, 100 degrees, 110 degrees) to change the angle between the first tapered portion 320 and the second tapered portion 324. The second tapered portion 324 may taper at a second angle different from the first angle (the angle of the first tapered portion 320) (where the angle is more clearly shown in ​ and 55 ). In an example, the second tapered portion 324 may taper radially inward (as shown in Figure 55 ). As shown in Figure 54 and 55 ), the second tapered portion 324 may be angled to extend radially inward in the direction from the intermediate portion 322 of the outer frame 306 to the distal end 326. The angle of the second tapered portion 324 may be a linear angle (e.g., as shown in Figure 55), or the second tapered portion 324 may have a curvature in an example. Other configurations of the outer frame (eg, other forms of outer frames disclosed herein) may be utilized as desired.

[0290] In an example, the outer frame 306 has a tapered shape such that the downstream or distal portion 316 has a smaller diameter than the middle portion 322 of the outer frame 306. The middle portion 322 may, for example, have a diameter in the range of about 35 mm to about 60 mm, with the distal portion 316 having a smaller diameter.

[0291] The outer frame 306 may include one or more gripping features 173 as disclosed herein. The gripping features 173 may be Figure 29A The gripping feature 173 shown in FIG. 1 is similarly constructed, or may be similar to the gripping feature 173 shown in FIG. Figure 19 -31 disclosed any other form of gripping features similarly constructed. Gripping feature 173 can be used with the gripping features described in connection with the embodiment of the present invention as desired. Figure 19 -31. The gripping features may include barbs in an example (or may have other forms as disclosed herein). The barbs may be disposed along the struts of the outer frame 306. The barbs may extend through the sealing skirt 308 to penetrate the tissue of the native heart valve. In an example, the prosthetic valve 280 may include a prosthetic valve 280 as desired. Figure 32 Any other features of any other examples disclosed herein may be utilized as desired.

[0292] refer to Figure 49 , the sealing skirt 308 or outer skirt can extend from the proximal portion 314 of the outer frame 306 to the distal portion 316 of the outer frame 306 over the outer surface 307 of the outer frame 306. The sealing skirt 308 can include a continuous or integral piece of material or fabric extending from the proximal portion 314 to the distal portion 316 along the outer surface 307 of the outer frame 306. The suture or suture line 330 is shown at the proximal portion 328 of the prosthetic valve 280, connecting the proximal end 331 of the sealing skirt 308 with the proximal end 333 of the inner skirt 332 (at Figure 53 Marked in the middle) connection.

[0293] refer to Figure 50, the distal end 337 of the sealing skirt 308 or the outer skirt can be coupled to the distal end 337 of the inner skirt 332 at the distal portion 340 of the prosthetic valve 280. A suture or stitching 342 can be positioned at the distal portion 340 of the prosthetic valve 280. The sealing skirt 308 or the outer skirt can extend across or span the gap 344 between the distal portion 300 of the inner frame 292 and the distal portion 316 of the outer frame 306. The suture or stitching 342 can be positioned at a location that can improve the ease of assembly of the prosthetic valve 280, since the suture or stitching 342 can be more accessible at the distal portion 340 of the prosthetic valve 280 than at an internal portion (e.g., an internal surface facing the flow channel 284).

[0294] Figure 53 The configuration of the inner skirt 332 is shown. The inner skirt 332 can extend from the proximal portion 298 of the inner frame 292 to the distal portion 300 of the inner frame 292. The prosthetic valve leaflets 282 can be sewn or otherwise coupled to the inner skirt 332. A suture or stitching 345 between the prosthetic valve leaflets 282 and the inner skirt 332 is shown. The inner skirt 332 can extend along the inner surface or the radially inward-facing surface of the inner frame 292. The inner skirt 332 can include any features of the skirts Figure 1-7G disclosed herein, including materials for reducing or promoting tissue formation or thrombus formation, or any configuration of the skirts Figure 1-7G disclosed. The outer skirt or sealing skirt 308 can include any features of the skirts Figure 1-7G disclosed herein, including materials for reducing or promoting tissue formation or thrombus formation, or any configuration of the skirts Figure 1-7G disclosed. Other forms of skirts can be utilized in the examples.

[0295] Unless otherwise noted, the anchor 304 can include the features of any other form of anchor disclosed herein. The anchor 304 can, for example, have a hook shape, or can be a hook-arm anchor, as Figure 1-11 disclosed. Unless otherwise noted, the anchor 304 can include the features of the anchors 44, 126. Unless otherwise noted, the anchor 304 can include the features of any other anchor (e.g., the anchors Figure 12-48 disclosed). The anchor 304 can be coupled to the distal portion 300 of the inner frame 292. The anchor 304 can extend radially outward from the distal portion 300 of the inner frame 292 and can extend across or span the gap 344 between the distal portion 300 of the inner frame 292 and the distal portion 316 of the outer frame 306. The anchor 304 is adapted to hook onto the native valve leaflets to anchor to the native valve. The distal portion 300 of the inner frame 292 and the distal portion 316 of the outer frame 306 are spaced apart by the gap 344.

[0296] Reference Figure 54 , each of the anchor members 304 can include a coupling portion 346, a drop loop 348 positioned radially outward of the coupling portion 346, and a tip portion 350 that includes the tip 352 of the corresponding anchor member 304. The tip portion 350 can extend from the drop loop 348 in the axially proximal direction or the inflow direction of the prosthetic valve 280. The drop loop 348 can include a bent or kinked portion that can angle the coupling portion 346 relative to the tip portion 350. Each of the anchor members 304 projects radially outward from the outer surface of the valve body 286. In an example, the tip 352 of the corresponding anchor member 304 can be positioned radially outside the outer surface 307 of the outer frame 306 (and the outer surface of the sealing skirt 308). The tip 352 of the corresponding anchor member 304 can overlap the outer surface 307 of the outer frame 306 (and the outer surface of the sealing skirt 308). Reference Figure 49 , the tip 352 of the anchor member 304 can be positioned between the "V" - shaped openings of the struts of the outer frame 306.

[0297] Figure 54 A cross - sectional view of the prosthetic valve 280 is shown, showing the skirt 356 (a combination of the sealing skirt 308 and the inner skirt 332) of the prosthetic valve 280 positioned on the frame 358 (a combination of the inner frame 292 and the outer frame 306) of the prosthetic valve 280. In an example, the skirt 356 can be tightly coupled to the frame 358 of the prosthetic valve 280 such that the skirt 356 tensions the frame 358. The tension applied to the frame 358 by the skirt 356 can create or change the taper of the outer frame 306. In an example, the tension can be applied from the skirt in combination with or alternatively by the anchor members 304.

[0298] Due to the tension provided by the skirt 356, the resulting taper of the outer frame 306 can be the taper as shown in Figure 54 and 55 . Such configurations can have various benefits. Reference Figure 55, for example, the taper of the second conical portion 324 can be a linear angle radially inward (e.g., a right angle). A large linear and continuous contact area 360 against the native valve leaflets 362 or other parts of the native valve (e.g., the annulus) can be provided (forming a frustoconical shape of the contact area of the prosthetic valve 280 around the circumference of the valve 280). The sealing against the native valve leaflets 362 or other parts of the native valve can be improved. The annulus engagement is improved. In addition, the tip portion 350 of the anchor 304 can be linear and can match the angle of the second conical portion 324 or have the same angle. Thus, the contact between the tip portion 350 and the outer surface of the outer body 290 can be improved. The native valve leaflets 362 can be compressed or clamped between the tip portion 350 and the outer surface of the outer body 290. In an example, the compression can be between the outer surface 307 of the outer frame 306 or the sealing skirt 308 or the outer surface of the outer skirt. The tip portion 350 and / or the outer body 290 can be biased into contact with each other or pressed against each other to provide compression or clamping of the native valve leaflets 362. The compression or clamping configuration as disclosed with respect to Figure 19-31 can be utilized.

[0299] As Figure 55 The configuration shown in can be different from the configuration including the protruding shoulder 370, which forms a convex or parabolic radially outwardly protruding rib (having a first curve labeled 371 and a second opposite curve labeled 372) with a double curvature or "S" curvature (having such a profile indicated by a dashed line in Figure 55 ). Thus, the protruding shoulder forming a rib extending circumferentially around the prosthetic valve can be excluded. A one-way bend of the curved portion or bent portion 322 can be utilized.

[0300] Figure 49-55 The features of the prosthetic valve of can be utilized alone or in combination with any other examples disclosed herein.

[0301] Variations in the configuration of the prosthetic valve 280 can be provided. For example, Figure 56 shows a variant in which the outer frame 306 is not directly coupled to the inner frame 292. The proximal portion 314 of the outer frame 306 is not directly coupled to the proximal portion 298 of the inner frame 292. In addition, the distal portion 316 of the outer frame 306 is not directly coupled to the distal portion 300 of the inner frame 292.

[0302] Figure 57 shows a top view of the separation or no direct contact or no direct coupling between the outer frame 306 and the inner frame 292.

[0303] Referring to Figure 58 and 59, the connection between the frames 292, 306 can be provided by a flexible body, connecting member, connecting skirt or intermediate member 380 that can extend between the proximal portion 298 of the inner frame 292 and the proximal portion 314 of the outer frame 306. The intermediate member 380 can allow the inner frame 292 to move into the outer frame 306. The connecting skirt or intermediate member 380 can include a continuation of the sealing skirt 308 or the inner skirt 332 and can extend radially between the proximal portion 298 of the inner frame 292 and the proximal portion 314 of the outer frame 306. Thus, the outer frame 306 can be coupled to the inner frame 292 using the connecting skirt or intermediate member 380 and using the distal portion 382 of the skirt 384 of the prosthetic valve. The connecting skirt or intermediate member 380 can include the proximal portion of the skirt 384, and the distal portion 382 of the skirt 384 can include a connecting skirt for the distal portions 300, 316 of the frames 292, 306. The connecting skirt or intermediate member 380 and the distal portion 382 of the skirt 384 can include a flexible tether connection between the proximal portion 298 of the inner frame 292 and the proximal portion 314 of the outer frame 306.

[0304] The flexible connection provided by the connecting skirt or intermediate member 380 and the distal portion 382 of the skirt 384 can allow the outer frame 306 to axially move relative to the inner frame 292 and to laterally tilt relative to the inner frame 292. The compliance and conformity to the shape of the native valve can be improved. The sealing with the native valve can be improved. The radial stiffness can be further reduced.

[0305] Figure 56-59 The features of the prosthetic valve can be utilized individually or in combination with any other examples disclosed herein.

[0306] Additional variations in the configuration of the prosthetic valve 280 can be provided. For example, Figure 60-63 shows a variant in which the inner frame 390 (shown in perspective in Figure 62 ) comprises two parts 392, 394 (or a first frame and a second frame) that are not integrally formed with each other. Figure 60 shows a side view of a first part 392 of the prosthetic valve including a sleeve portion or a cylindrical portion of the inner frame 390, which is similarly constructed to the inner frame 292 shown in Figure 51 . The first part 392 can include struts and enclose a flow channel for the prosthetic valve leaflets 282. The first part 392 extends axially from a proximal portion 396 to a distal portion 398. The first part 392 includes a sleeve portion that supports the prosthetic valve leaflets 282, and the features of the proximal portion 396 and the distal portion 398 correspond to the corresponding features of the proximal portion 298 and the distal portion 300 of the inner frame 292.

[0307] Figure 61A perspective view of the second portion 394 or the second frame is shown. The second portion 394 may include a support frame 400 coupled to an anchor 402, which may be constructed similarly to the anchor 304 unless otherwise noted. The support frame 400 may include a ring for surrounding a flow channel for the prosthetic valve leaflets 282. The support frame 400 may include a plurality of longitudinally extending struts 404, with openings 406 therebetween and defined by the struts 404. The second portion 394 may include struts of the ventricular anchor.

[0308] The second portion 394 may be made of a material having a thickness 410 (marked in Figure 63 ), which is smaller than the thickness 412 of the material forming the first portion 392 (marked in Figure 63 ), in the radial dimension. With the smaller radial thickness. Thus, Figure 61 each component shown in Figure 60 may have a thickness 410 that is smaller than the thickness 412 of the components shown in Figure 61 . Such a feature may beneficially reduce the stiffness of the arms of the anchor 402 formed in Figure 60 to increase the compliance with the implantation site. The anchor 402 may be more deflectable inwards and outwards and may have a reduced radial stiffness. Figure 60 The first portion 392 shown in

[0309] may have a greater stiffness to support the prosthetic valve leaflets 282 using the flow channel. Figure 62 The first portion 392 may be coupled to the second portion 394, for example, as shown in

[0310] Figure 63 . A suture connection or other form of coupling may couple the first portion 392 to the second portion 394. The support frame 400 may be positioned at the distal portion 398 of the inner frame 390 and may be positioned radially medial (or may be positioned radially lateral in the example) of the inner frame 390. The anchor 402 may project radially outwards.

[0311] Figure 61-63 The features of the prosthetic valve of

[0312]

[0313] Figure 64A For example, with reference to Figure 64A, a top view showing the configuration of the frame 420, includes an outer frame 422 having notches, cavities or recesses 424 for receiving the tip 426 of the anchor 428. Unless otherwise stated, the anchor 428 may be constructed similarly to the anchor 304.

[0314] The recess 424 may include a formed arcuate section of the outer frame 422 that projects radially inward from the outermost surface 430 of the outer frame 422. The recesses 424 may be circumferentially spaced from each other around the outer surface of the outer frame 422 and positioned to be circumferentially aligned with the position of the anchor 428. The recesses 424 may be elongated and may extend axially along the outer frame 422. Axially extending concave recesses 424 for receiving the anchor 304 may be utilized. The circumferential width 432 of each recess 424 may be set to be equal to or greater than the width of each tip 426. The radial depth 434 of each recess 424 may be set to be equal to or greater than the radial thickness of each tip 426 of the anchor 428. Each recess 424 may be configured to receive the tip 426 of the anchor 428, where the radius of the tip 426 is the same as or smaller than the outermost surface 430 of the outer frame 422. In an example, the recess 424 may be configured such that the tip 426 of the anchor 428 is partially or at least partially recessed inwardly from the outer frame 422.

[0315] Figure 64B Shows Figure 64A a side perspective view of the configuration shown in Figure 65 A perspective view showing a prosthetic valve 431 utilizing the frame 420, where the sealing skirt 308 is positioned on the outer surface of the outer frame 422. Figure 66 A side cross-sectional schematic view of the tip 426 within the recess 424 is shown. The tip 426 is shown projecting to a radius that is the same as or smaller than the radius of the outermost surface 430 of the outer frame 422. The sealing skirt 308 may be positioned between the tip 426 and the outer frame 422.

[0316] As Figure 64A –66, the configuration shown can beneficially reduce the outer profile or outer diameter of the prosthetic valve. The radially outwardly directed force can be reduced. One or more leaflets engaged by the anchor 428 can be pressed into the corresponding recess 424 and fixed within the recess 424. In an example, grasping features as disclosed herein (e.g., as disclosed in Figure 19 –31 and 52, or other forms of grasping features) can be used to fix the leaflet in the space between the tip 426 of the anchor 428 and the outer frame 422.

[0317] Figure 64A-66 The features of the prosthetic valve of

[0318] Alternative configurations can be provided such that the anchor utilized has a radius equal to or less than the outer surface of the outer body, or the anchor is inserted or nested within the outer body.

[0319] Reference Figure 67 , shows a perspective view of the prosthetic valve 440. Unless otherwise stated, the prosthetic valve 440 can incorporate the features of the prosthetic valve 280. The prosthetic valve 440 has anchors 442, each anchor having a tip 444 positioned distally of the outer frame 306 (shown in Figure 70 ). The position of the tip 444 distally (or in the outflow direction) of the outer frame 306 allows the tip 444 to project to a radius equal to or less than the radius of the outer frame 306. There is an axial gap between the tip 444 and the outer frame 306. The outer frame 306 does not prevent the tip 444 from being positioned at a radius equal to or less than the radius of the outer frame 306.

[0320] The configuration as shown in Figure 67 can be provided in various ways. In an example, the relative axial height of the distal end of the outer frame 306 and the tip 444 can be offset such that the tip 444 is positioned distally of the outer frame 306. In an example, the axial height of the anchor 442 can be reduced from the height of the anchor 304 shown in Figure 49 . The reduced axial height allows the tip 444 to be inserted into the struts of the outer frame 306 or nested beneath or distally of the shown struts. In an example, the axial height of the outer frame 306 can be adjusted to position the distal end of the outer frame 306 proximally of the tip 444 to allow the tip 444 to be inserted or nested distally of the struts of the outer frame 306.

[0321] It can be such that Figure 49 compared to the prosthetic valve 280 shown in, the radial span or outer profile of the prosthetic valve 440 is reduced. Figure 68 Shows a top view of the prosthetic valve 440, showing that the distance the tip 444 projects does not extend beyond the outer surface of the outer frame 306. The outer profile or outer diameter of the prosthetic valve is reduced. The radially outwardly directed force can be reduced.

[0322] Figure 69 Shows a top view of the outer frame 306 and the inner frame 292, where the tip 444 of the anchor 442 has the Figure 67 reduced height shown in. The tip 444 is positioned radially medial to the outer surface 307 of the outer frame 306. The tip 444 can be positioned radially medial to the outer surface 307 in an example, or can be at the same radius. For example, the outer frame 306 can be radially inwardly compressed by a skirt as disclosed herein, but the tip 444 can remain at a radius equal to or less than the outer radius of the outer frame 306, as shown in Figure 67 .

[0323] Figure 70 A side view of the tip 444 positioned distally of the outer frame 306 is shown. The tip 444 is positioned distally of the most distal strut 446 of the outer frame 306. The most distal strut 446 may extend axially and define an opening 448 or the most distal opening positioned between adjacent most distal struts 446. In the configurations as shown and discussed with respect to Figure 28 the tip 444 may be positioned within the opening 448. In an example, the tip 444 may be positioned distally of the opening 448.

[0324] Figure 71 A side cross-sectional schematic view of the configuration as shown in Figure 70 is shown. A skirt (e.g., the sealing skirt 308) may be positioned radially inwardly of the tip 444 as disclosed herein. An autologous valve leaflet may be positioned between the tip 444 and the skirt and may be clamped in place. In an example, a grasping feature (e.g., as disclosed in Figure 19 –31 and 52, or other forms of grasping features) as disclosed herein may be used for additional fixation of the autologous valve leaflet. For example, Figure 70 a grasping feature 173 positioned proximate the tip 444 in the configuration as shown in Figure 28 is shown. The grasping feature 173 may be utilized in the manner disclosed herein.

[0325] In an example, the tip 444 may be partially recessed or at least partially recessed relative to the outer surface 307 of the outer frame 306.

[0326] Figure 67-71 The features of the prosthetic valve of

[0327] Figure 72 –75 may be utilized individually or in combination with any other examples disclosed herein. Figure 67 –71 show that a portion of the anchor of the prosthetic valve 450 includes the anchor 442 discussed with respect to Figure 26 and a portion of the anchor includes a variant of the anchor 304 of the prosthetic valve 280. Each of the anchors 304 has a tip 352 positioned radially outside of the outer frame 306 and overlapping the outer surface 307 of the outer frame 306. For example, such configurations are shown in Figure 67 –71. Each of the anchors 442 has a tip 444 positioned distally of the outer frame 306, as discussed with respect to Figure 67 –71. The anchors 442 may each project to a radius equal to or less than the radius of the outer surface 307 of the outer frame 306. The anchors 442 have tips that are at least partially recessed radially inwardly from the outer surface of the prosthetic valve. Other features of the anchors 442 discussed with respect to

[0328] In Figure 72 the configuration shown, the anchors 304, 442 can be coupled to the inner frame 292. Accordingly, the heights of the anchors 304, 442 can be offset such that the tip 444 of the anchor 442 extends to a smaller axial height 451 in the proximal direction (or inflow direction) than the tip 352 of the anchor 304.

[0329] In an example, due to the height offset 452 between the drop loop 348 of the anchor 304 and the drop loop 454 of the anchor 442, a height offset of the tips 352, 444 can be created. The position of the drop loop 454 of the anchor 442 axially protrudes in the distal direction relative to the drop loop 348 of the anchor 304. This feature extends the anchor 442 in the distal direction (or outflow direction) to reduce the height of the tip 444. Accordingly, the height of the tip 444 is correspondingly reduced without a corresponding or equal reduction in the length of the tip portion 456.

[0330] In an example, at least one of the anchors of the prosthetic valve can include the anchor 304, and at least one of the anchors can include the anchor 442. In an example, the anchor 442 can be positioned at a desired location around the outer circumference of the prosthetic valve to provide a reduced radial span or outer profile of the prosthetic valve at that location.

[0331] For example, referring to Figure 73 , a schematic top view of a prosthetic valve 450 is shown, where a portion 462 of the outer circumference includes the anchor 442, and a portion 464 includes one or more of the anchors 304. In an example, the portion 462 can be positioned to reduce the radial span or outer profile of the prosthetic valve 450 at that portion 462. In an example where the prosthetic valve 450 includes a prosthetic tricuspid valve, the portion 462 can include the septal side of the prosthetic valve 450, which is adapted to face the septal side of the native tricuspid valve. Accordingly, a reduced radial pressure and a possible conduction disorder with the tricuspid valve can occur at the portion 462. Other configurations can be utilized in an example.

[0332] The relative sizes of the portions 462, 464 can vary in an example. As Figure 73 and 74As shown, portion 464 may include at least 200 degrees of the outer circumference of the prosthetic valve 450. Thus, portion 462 may include 160 degrees or less. In an example, portion 464 may include at least 180 degrees of the outer circumference. Portion 462 may include 180 degrees or less. In an example, various other ratios (e.g., larger or smaller sizes of portions 462, 464) may be utilized. Portions 462, 464 may include arcs of the total outer circumference of the prosthetic valve 450. Portions 462, 464 are circumferentially adjacent to each other around the outer circumference of the prosthetic valve 450.

[0333] In an example, portion 464 may include at least two of the anchors 304, or at least three of the anchors 304, or other amounts (e.g., at least four, five, etc.). Portion 462 may include at least two of the anchors 442, or at least three of the anchors 442, or other amounts (e.g., at least four, etc.). For example, Figure 74 A configuration of the anchors 304, 442 is shown, where portion 464 includes five anchors 304 and portion 462 includes four anchors 442. The anchors 304, 442 may be equally circumferentially spaced from each other. In an example, unequal circumferential spacing may be utilized.

[0334] Figure 75 A cross-sectional view of the prosthetic valve 450 is shown, showing the use of both the anchor 304 and the anchor 442. An asymmetric configuration of the anchors 304, 442 is created, where portion 462 of the prosthetic valve 450 utilizes the anchor 442 and portion 464 utilizes the anchor 304. In an example, the anchors 304, 442 may be compressed against a gripping feature as disclosed herein (e.g., as disclosed in Figure 19 –31 and 52, or other forms of gripping features). The gripping feature may be used to hold the leaflet in the space between the respective tip of the anchor and the outer frame 306. For example, the tip 352 of the anchor 304 may overlap with the gripping feature to press against the autologous valve leaflet toward the gripping feature to reduce movement of the leaflet relative to the valve body 453.

[0335] Figure 72-75 The features of the prosthetic valve may be utilized alone or in combination with any other examples disclosed herein. Alternative configurations may be provided such that the utilized anchor has the same or a smaller radius as the outer surface of the outer body, or the anchor is inserted or nested within the outer body. For example, Figure 76A top schematic view showing the configuration of the prosthetic valve 470 is presented, where anchor 304 is utilized and anchor 472 having an axial height smaller than that of anchor 304 is used. Each of the anchors 472 has a height set such that the tip of the anchor 472 is distal to the outer frame 474 of the prosthetic valve 470. The outer frame 474 has an oval outer contour (or a non-uniform circular outer contour) such that part 476 of the outer frame 474 extends all or partially above the anchor 472. Thus, the radial span of the anchor 472 starting from the outer surface of the outer frame 474 is reduced. The outer frame 474 can extend outwardly, where the large-diameter part 476 is used for at least one-third of the prosthetic valve 470. Other ratios can be utilized in the examples. In an example, part 476 can have a wider strut opening to accommodate the tip of any of the anchors disclosed herein.

[0336] Figure 76 The features of the prosthetic valve can be utilized individually or in combination with any of the other examples disclosed herein.

[0337] Additional variations in the configuration of the prosthetic valve 280 can be provided. For example, Figure 77 –86 shows a variant in which one or more snap anchors 480 can be utilized. Figure 77 A side perspective view of the inner frame 292 is shown, demonstrating the snap anchor 480 coupled to the distal portion 300 of the inner frame 292. The anchor 304 can be coupled to the inner frame 292.

[0338] The prosthetic valve 482 (labeled in Figure 79 utilizing one or more snap anchors 480 can be divided into sections in a manner similar to that disclosed with respect to Figure 73 and Figure 74 For example, referring to the top schematic view of Figure 78 , the outer circumference of the prosthetic valve 482 can be divided into a part 484 that includes the snap anchor 480 and a part 486 that includes one or more anchors 304. Part 484 can be opposite part 486. In an example, part 484 can be positioned to reduce the radial span or outer contour of the prosthetic valve at that part 484. In an example where the prosthetic valve 482 includes a prosthetic tricuspid valve, part 484 can include the septal side of the prosthetic valve 482, which is adapted to face the septal side of the native tricuspid valve. Thus, a reduction in radial pressure and a possible conduction disorder with the tricuspid valve can occur at part 484. Other configurations can be utilized in the examples.

[0339] The relative sizes of parts 484, 486 can vary in the examples. As Figure 78As shown, portion 486 can include at least 200 degrees of the outer circumference. Thus, portion 484 can include 160 degrees or less. In an example, portion 486 can include at least 180 degrees of the outer circumference. Portion 484 can include 180 degrees or less. In an example, various other ratios (e.g., larger or smaller sizes of portions 484, 486) can be utilized. Portions 484, 486 can include arcs of the total outer circumference of the prosthetic valve 482. Portions 484, 486 are circumferentially adjacent to each other around the outer circumference of the prosthetic valve 482.

[0340] In an example, portion 486 can include at least two of the anchors 304, or at least three of the anchors 304, or other amounts (e.g., at least four, five, etc.). Portion 484 can include at least two of the snap anchors 480, or at least three of the snap anchors 480, or other amounts (e.g., at least four, etc.). For example, Figure 78 A configuration of the anchors 304, 442 is shown, where portion 486 includes five anchors 304 and portion 484 includes two snap anchors 480. The anchors 304 are shown equally spaced from each other, and the snap anchors 480 are shown equally spaced from each other. In an example, unequal circumferential spacing can be utilized.

[0341] Figure 79 A perspective view of the prosthetic valve 482 is shown. The snap anchors 480 are coupled to the valve body 286. Each of the snap anchors 480 includes a tip 490 that is adapted to overlap with the outer surface 307 of the outer frame 306 and is adapted to snap a portion of a native valve (e.g., a native valve leaflet) between the tip 490 and the outer surface 307 of the outer frame 306 to anchor to the native valve. The snap anchors 480 are adapted to snap a native valve leaflet against the outer surface 287 of the valve body 286. The snap anchors 480 are spring biased radially inwardly toward the center of the prosthetic heart valve.

[0342] Figure 80 A flat pattern of the inner frame 292 is shown, showing the arms of the anchors 304 extending distally from the distal portion 300 of the inner frame 292 in an elongated configuration. The distal portion 300 includes a coupler 492 for coupling to the snap anchors 480. Figure 81A plan view of the arm of the snap anchor 480 is shown. The snap anchor 480 extends longitudinally to the tip 490 of the snap anchor 480. The snap anchor 480 includes a coupler 494 for coupling with a coupler 492 of the inner frame 292. The snap anchor 480 may include windows or openings 495, 497 to reduce the material of the snap anchor arm and to receive heart valve leaflet tissue therein when needed. The couplers 492, 494 may be coupled using suture connectors or other forms of connectors as needed.

[0343] The shape of the snap anchor 480 may be configured to bend outwardly towards the outer frame 306. Refer to Figure 82 , for example, the shape of the snap anchor 480 may be configured to bend in the proximal direction and thus press radially inwards towards the outer frame 306. The snap anchor 480 may overlap with the outer frame 306, as Figure 82 shown. The deflection of the snap anchor 480 may create a drop loop 500, as Figure 86 shown in the cross-sectional view of. The drop loop 500 may create a spring bias that may be similar to the bias of a torsion spring to guide the tip 490 towards and against the outer frame 306. The snap anchor 480 may be spring biased towards the valve body 286.

[0344] In an example, the tip 490 may have a circumferential planar shape such that a flat profile is created against the outer surface of the valve body 286. Thus, the tip 490 may be positioned flush against the outer surface of the valve body 286, as Figure 78 shown in the schematic view of. Thus, the outer profile of the prosthetic valve 482 may be reduced.

[0345] In an example, the configuration of the snap anchor 480 may vary. For example, Figure 83 shows a variant in which the snap anchor 504 includes a flexible portion 502 to enhance the flexibility of the anchor 504 at that portion 502. The flexible portion 502 may include a undulating pattern or a rachis pattern of the arm at that portion 502. The snap anchor 504 may be otherwise constructed similarly to the snap anchor 480 and may include a tip 505 and a coupler 506 for coupling to the coupler 492. A window or opening 507 may be located at the tip 505.

[0346] Figure 84 shows a variant in which the snap anchor 510 is constructed similarly to the snap anchor 504 but includes additional barbed snaps 512 that may be located in the Figure 82 position of the grasping feature 173 shown in. The barbed snaps 512 may be positioned to engage the native valve leaflets when the snap anchor 510 is closed.

[0347] Figure 85 Shows a linear configuration of a snap anchor 514 including an arm 516, the tip 518 of the arm having a window or opening 520. The snap anchor 514 includes a top snap 522 and a coupler 524 for coupling to a coupler 492.

[0348] Figure 86 Shows a cross-sectional view of a prosthetic valve 482, showing a snap anchor 480 positioned against an outer surface 287 of the valve body 286.

[0349] Variations in the coupling of the snap anchor 480 can be provided. For example, Figure 87 Shows a variation in which a snap anchor 530, similarly constructed to the snap anchor 480, is coupled to an outer frame 306. The snap anchor 530 can be coupled to a distal portion 316 of the outer frame 306.

[0350] In addition, in an example, grasping features as disclosed herein (e.g., as Figure 19 –31 and Figure 52 disclosed, or other forms of grasping features) can be used to secure the leaflets in the space between either the snap anchor and the anchor 304 and the outer frame 306 in the manner disclosed herein. The snap anchor or the anchor 304 can overlap the outer frame 306 having the grasping features, or clamping can occur in other ways.

[0351] Additional variations of any of the prosthetic valves disclosed herein can be provided. In an example, any of the anchors disclosed herein (which can include hook arm anchors or snap anchors) can be excluded at a portion of any prosthetic valve such that the spacing of the remaining anchors is unequal. One or more anchors can be excluded along the circumference of the prosthetic valve. In a tricuspid valve deployment, an anchor can be excluded on the septal portion of the prosthetic valve. In an example, the portion of the prosthetic valve having at least partially recessed anchors or having snap anchors can have the anchors completely excluded.

[0352] Figure 88 –90 shows an exemplary deployment sequence of the prosthetic valve 482 onto an autologous heart valve. Figure 88 Shows the anchors 304, 480, each in a linearized, extended, or compressed configuration within a capsule 540 of a delivery system or delivery catheter. In the linearized, extended, or compressed configuration, the snap anchor 480 can have a greater length than the anchor 304. The capsule 540 approaches an autologous heart valve, which can be an autologous tricuspid valve in an example. The autologous heart valve can include leaflets 91a, 91b.

[0353] Figure 89Shows a partially deployed prosthetic heart valve 482, where the anchor 304 is partially deployed, and the snap anchor 480 extends radially outward from the capsule 540. The snap anchor 480 can capture the native valve leaflet 91a and can press the leaflet 91a against the outer surface of the capsule 540 in the partially deployed configuration. The capsule 540 can be retracted from this position to allow the snap anchor 480 to press the leaflet 91a against the outer surface 287 of the valve body 286, e.g., as Figure 90 shown.

[0354] Figure 90 Shows the deployed configuration of the prosthetic heart valve 482, where the snap anchor 480 snaps the leaflet 91a against the outer surface 287 of the valve body 286.

[0355] Variations of the delivery system can be provided. For example, Figure 91 Shows a variation where the delivery system 550 includes a tether 552 coupled to the snap anchor 480 to control the closing and / or opening of the snap anchor 480. The tether 552 can be tensioned to open the snap anchor 480 and can release the tension to allow the snap anchor 480 to close. Thus, control over the opening and closing of the snap anchor 480 can be provided.

[0356] The tether 552 can extend to the shaft of the delivery system 550, such as the guide wire lumen 554, or other shafts of the delivery system 550. The tether 552 can pass through a channel in the shaft to reach the proximal portion of the delivery system 550 for actuation. The proximal portion 556 of the tether 552 can be actuated at the handle or other extracorporeal portion of the delivery system 550.

[0357] In an example, the prosthetic heart valve 482 can include only snap anchors (and no hook arm anchors) circumferentially distributed around the prosthetic heart valve 482.

[0358] Figure 77-91 The features of the examples of

[0359] Additional variations of the configuration of the prosthetic valve 280 can be provided. Figure 92-96 Shows a variation where the prosthetic valve 600 includes one or more support arms 602. Unless otherwise noted, the prosthetic valve 600 can include the features of the prosthetic valve 280. Each support arm 602 can have a proximal portion 604 coupled to the valve body 606 and a distal portion 608 that projects from the valve body 606 in the axially distal or outflow direction. The support arms 602 can project from the distal portion 607 of the valve body 606. The support arms 602 can extend in the distal or outflow direction to the tip 609 of the respective support arm 602.

[0360] The support arm 602 can be positioned at a portion 610 of the prosthetic valve 600. The prosthetic valve 600 can be divided into portions in a manner similar to that discussed with respect to Figure 73 and 78 For example, the prosthetic valve 600 can include a portion 610 and a portion 612 that includes the anchor 304. The portions 610, 612 can be opposite each other. The relative sizes of the portions 610, 612 can vary in the example. For example, the portion 612 can include at least 200 degrees of the outer circumference of the prosthetic valve 600. Thus, the portion 610 can include 160 degrees or less. In an example, the portion 612 can include at least 180 degrees of the outer circumference. The portion 610 can include 180 degrees or less. In an example, various other ratios (e.g., larger or smaller sizes of the portions 610, 612) can be utilized. The portions 610, 612 can include arcs of the total outer circumference of the prosthetic valve 600. The portions 610, 612 are circumferentially adjacent to each other around the outer circumference of the prosthetic valve 600.

[0361] The support arm 602 can extend at the circumferential portion 610. The prosthetic valve 600 can not have hook arm anchors that radially project outward from the outer surface of the valve body at the portion 610. The number of support arms 602 can vary from at least one to at least two or at least three or a greater number. The anchor 304 can include at least one, at least two, at least three or a greater number (e.g., Figure 92 six are shown in

[0362] In a tricuspid valve deployment, the portion 610 can be configured to be positioned at the septal side of the tricuspid valve. Thus, a reduced radial profile can be created at the septal side of the tricuspid valve to reduce the likelihood of conduction disorders at the tricuspid valve.

[0363] When deployed to an autologous valve between the atrium and ventricle, the support arm 602 can be adapted to extend into the ventricle. The support arm 602 can be adapted to stabilize the prosthetic valve 600 within the autologous valve. The support arm 602 can, for example, contact the heart wall within the ventricle to stabilize the prosthetic valve 600, or can be otherwise positioned to stabilize the prosthetic valve 600. The support arm 602 can reduce tilting or rocking of the prosthetic valve 600 during the pulsatile movement of the heart and due to the absence of hook anchors at the portion 610. Thus, the support arm 602 can account for the absence of hook anchors at the portion 610.

[0364] The support arm 602 can extend from the inner frame 292 (as shown in Figure 92 ), or in an example can extend from the outer frame 306. The support arm 602 can, for example, be coupled to the distal portion of the inner frame 292 or the distal portion of the outer frame 306.

[0365] In an example, the support arm 602 can be formed of the structure of the anchor 304, but is shaped to project in the distal or outflow direction. Thus, the support arm 602 can include the anchor 304, which is not shaped to form a hook but is shaped to extend axially or linearly. Other configurations of the support arm 602 can be utilized in an example.

[0366] In an example, the outer surface 614 of the valve body 606 can include friction elements 616. The friction elements 616 are adapted to provide friction with the native heart valve, such as with native valve leaflets or the annulus. As Figure 92 and 93 shown, the friction elements 616 include a plurality of barbs 618, which can be positioned on a sheet of material 620. The barb sheet 620 is shown separately in Figure 94 The sheet 620 can include a plurality of arms 622 that define openings 624. The barbs 618 can be positioned on the arms 622. In an example, the barbs 618 can be flat or coplanar with the sheet 620 such that the barbs 618 do not project radially outward from the sheet 620. The barbs 618 can extend parallel to the plane of the outer surface of the valve body 606. The barbs 618 being coplanar with the sheet 620 can reduce the likelihood of damage to the deployment capsule due to the barbs 618 when releasing the prosthetic valve 600 from the capsule. In an example, the barbs 618 can be configured to project radially outward from the sheet 620, or other configurations can be provided. In an example, the arms 622 can be shaped to match the shape of the struts of the outer frame 306.

[0367] The sheet 620 can be positioned on the outer surface 614 of the valve body 606, as shown in Figure 92 and 93 In an example, the sheet 620 can be positioned inside the skirt 308, and the barbs 618 can be adapted to project through the skirt 308.

[0368] Other forms of friction elements can be utilized in an example, such as a rough surface of the outer frame or outer skirt, a fuzzy textile, or other forms of barbs, etc.

[0369] Figure 95 and 96 show an exemplary deployment sequence. Referring to Figure 95 , the anchor 304 is in a linearized, extended, or compressed configuration, and the support arm 602 is also shown extending within the delivery capsule 630. The delivery capsule can be retracted in a similar manner as disclosed herein, where the anchor 304 flips or rotates to hook the leaflet 91b. The support arm 602 can continue to project axially due to its shape.

[0370] For example, referring to Figure 96, the anchor 304 hooks the leaflet 91b, and the support arm 602 projects axially into the ventricle to stabilize the prosthetic valve 600. The support arm 602 can be positioned adjacent to the heart wall 632 of the ventricle or can contact the heart wall. The support arm 602 can contact the inner heart wall 632 within the ventricle to stabilize the prosthetic valve 600 within the tricuspid valve. The tilt of the prosthetic valve 600 can be reduced by the presence of the support arm 602. The friction element 616 can engage the leaflet 91a and / or the annulus to fix the portion 610 of the prosthetic valve 600 in place. The likelihood of atrial migration and embolization can be reduced.

[0371] In an example, a transjugular access of the prosthetic valve 600 can be utilized.

[0372] Figure 92-96 The features of the examples can be utilized individually or in combination with any other examples disclosed herein.

[0373] Figure 97 A variant is shown in which the support arm 602 includes a piercing element 640 for piercing the heart wall of the ventricle to fix the support arm 602 to the heart wall. The piercing element 640 can include barbs, tips, or screw tips, or other forms of piercing elements for piercing tissue. The piercing element 640 can be at the tip of the support arm 602. During deployment, the piercing element 640 can penetrate into the tissue of the heart wall.

[0374] Examples of prosthetic valves can be used in the mitral or tricuspid valves as disclosed herein, or can be used in other deployment locations. The size of the prosthetic heart valve can be sized to replace the native mitral or tricuspid valve. Deployments to the aortic or pulmonary valves, or other implant sites, can be utilized.

[0375] Figure 98An example of a delivery system 650 is shown. Features of the delivery system 650 that may be utilized are disclosed in U.S. Provisional Application No. 63 / 436,051, filed Dec. 29, 2022, and U.S. Provisional Application No. 63 / 533,458, filed Aug. 18, 2023, the entire contents of each of which are hereby incorporated by reference. The delivery system 650 can be used to deploy an implant as disclosed herein or another form of implant. An implant such as a prosthetic heart valve can be delivered to the mitral or tricuspid annulus or other heart valve location of a subject in a variety of ways, such as by open surgery, minimally invasive surgery, and percutaneous or transcatheter delivery through the vasculature of the subject. An exemplary transfemoral approach is further described in U.S. Patent Publication No. 2015 / 0238315, published Aug. 27, 2015, the entire contents of which are hereby incorporated by reference in their entirety. Although the delivery system 650 is described in connection with a percutaneous delivery method and more specifically a transfemoral delivery method, it should be understood that the features of the delivery system 650 can be applied to other delivery methods, including delivery systems for transapical or transjugular delivery methods.

[0376] The delivery system 650 can be used to deploy a prosthesis (e.g., a replacement heart valve as described in this specification) to a location within the body of a subject. The delivery system 650 can include a plurality of components, devices, or subassemblies. The delivery system 650 can include a delivery catheter or elongate catheter or delivery device 652 and a stabilizer assembly 654, as well as other components as needed. The delivery device 652 can include an elongate shaft or shaft assembly 656 and a housing in the form of a handle 658. The housing can be at the proximal portion of the elongate shaft or shaft assembly 656. The shaft assembly 656 can include one or more shafts. According to examples herein, multiple shafts can be provided, but in an example, a single shaft can be utilized. The shaft assembly 656 can include a capsule 660 that can hold the implant in a compressed configuration, where the capsule 660 retracts to deploy the implant. In an example, sutures can be attached to the implant for releasing the implant at the implant site. For example, a tether assembly can be used for release.

[0377] Percutaneous and transseptal implantations can be utilized. Implantation of the tricuspid valve can be utilized.

[0378] Figure 99 A schematic representation of a method of delivering an autologous tricuspid valve is shown. As Figure 99 shown, in one example, the delivery system can be placed in the ipsilateral femoral vein 704 and advanced toward the right atrium 706. In an example, the method can begin in the inferior vena cava (or begin in the superior vena cava).

[0379] Figure 99The figure shows a delivery system extending from the ipsilateral femoral vein 704 to the right atrium 706. In the examples of the present disclosure, a guide wire is not required to position the delivery system in place, but in other examples, one or more guide wires may be used.

[0380] Accordingly, it may be advantageous for a user to be able to manipulate the delivery system through the complex regions of the heart in order to position the replacement tricuspid valve in line with the native tricuspid valve. This task may be performed with or without the guide wire of the system disclosed above. The distal end of the delivery system may be advanced into the right atrium 706. Then, the user may manipulate the delivery system to align the distal end of the delivery system with the appropriate region. In addition, the user may twist the entire delivery system to further manipulate and control the position of the delivery system. In the fully bent configuration, the user may then place the replacement valve in place. This may advantageously allow the replacement valve to be delivered to the in-situ implantation site, such as the native tricuspid valve.

[0381] Figure 100 A schematic representation of the distal end of the delivery system approaching the native tricuspid valve is shown. The distal end of the delivery system may be positioned relative to the implantation site as needed before releasing the implant from the implant holding region.

[0382] Figure 101 It is shown that the implant may be released from the delivery system using a tether assembly 662 coupled to the implant. The position of the anchor relative to the native valve leaflets may be determined and, if in the appropriate position, the implantation procedure may proceed.

[0383] Figure 102 An implant in the expanded configuration is shown, where the tether assembly 662 is coupled to the implant. The position of the anchor relative to the native valve leaflets may be determined and, if in the appropriate position, the implantation procedure may proceed.

[0384] The tether assembly 662 may be released from the implant using the release of the release assembly. Figure 103 The release of the tether assembly 662 is shown. Figure 104 The implant deployed in place is shown.

[0385] A similar deployment procedure may be utilized with the mitral valve as needed. For example, a transseptal puncture may be performed from the right atrium 706 (marked in Figure 99 to enter the left atrium 708. Then, the user may pass the bent delivery system through the transseptal puncture and into the left atrium 708. Then, the delivery system may be advanced into the left atrium 708 and then towards the left ventricle 710. The implant may be deployed in a similar manner as shown in Figure 99 –104.

[0386] The delivery systems disclosed herein can be utilized with any of the examples disclosed herein.

[0387] Various modifications of the examples disclosed herein can be provided. Among the examples, the features of the examples can be modified, substituted, excluded, or combined as needed. Combinations of the features among the examples can be provided as needed. Combinations of the features among the examples can be provided, and other features of such examples can be excluded as needed.

[0388] The various examples of the sealing skirt disclosed herein can have various forms, including a cloth skirt, a foam skirt, or a braided skirt as needed. Various materials can be used as needed.

[0389] The implant disclosed herein can include a prosthetic heart valve or other forms of implants, such as stents or filters, or diagnostic devices, etc. The implant can be a dilatable implant configured to move from a compressed or undeployed state to a dilated or deployed state. The implant can be a compressible implant configured to compress inward to have a reduced outer profile and move the implant to a compressed or undeployed state.

[0390] Various forms of delivery devices can be used in the examples disclosed herein. The delivery devices as disclosed herein can also be used for the replacement and repair of the aorta, mitral valve, tricuspid valve, and pulmonary artery. The delivery device can include a delivery device for delivering other forms of implants, such as stents or filters, or diagnostic devices, etc.

[0391] The implants and systems disclosed herein can be used for transcatheter mitral or tricuspid valve implantation, as well as aortic valve implantation (TAVI) or replacement of other native heart valves (e.g., pulmonary valve). The delivery devices and systems disclosed herein can be used for transarterial access (including transfemoral access) to a patient's heart. The delivery devices and systems can be used for transcatheter percutaneous procedures, including transarterial procedures, which can be transfemoral. In addition, transapical procedures can also be used. Other procedures can be utilized as needed.

[0392] Furthermore, the methods herein are not limited to the specifically described methods and can include methods using the systems and devices disclosed herein. The steps of the methods can be modified, excluded, or added with the systems, devices, and methods disclosed herein. In an example, the examples disclosed herein can include a system for implanting into the human body.

[0393] For purposes of this description, certain aspects, advantages, and novel features of examples of the disclosure are described herein. The disclosed methods, devices, and systems should not be construed in any way as limiting. Rather, the disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, together and in various combinations and sub-combinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed examples do not require the presence of any one or more specific advantages or the solving of any particular problems. Features, elements, or combinations of one example may be combined into other examples herein.

[0394] Example 1: A prosthetic valve configured to be deployed to an autologous valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; and a valve body that supports the one or more prosthetic valve leaflets, wherein at least a portion of the prosthetic valve comprises a material configured to reduce tissue formation or thrombus formation along the portion of the prosthetic valve.

[0395] Example 2: The prosthetic valve according to any example herein, specifically the prosthetic valve of Example 1, wherein the portion of the prosthetic valve comprises a skirt.

[0396] Example 3: The prosthetic valve according to any example herein, specifically the prosthetic valve of Example 2, wherein the prosthetic valve comprises a frame and the skirt is positioned on the frame.

[0397] Example 4: The prosthetic valve according to any example herein, specifically the prosthetic valve of Examples 1 to 3, wherein the one or more prosthetic valve leaflets are positioned within a flow channel of the prosthetic valve, and the prosthetic valve comprises a valve body having an outer surface facing outward from the flow channel and an inner surface facing the flow channel, and the portion of the prosthetic valve comprises the inner surface of the valve body.

[0398] Example 5: The prosthetic valve according to any example herein, specifically the prosthetic valve of Example 4, wherein the outer surface of the valve body is configured for tissue formation or thrombus formation on the outer surface of the valve body.

[0399] Example 6: The prosthetic valve according to any example herein, specifically the prosthetic valve of Example 4 or Example 5, wherein the outer surface comprises an end portion and the inner surface comprises an end portion proximate the end portion of the outer surface, and the portion of the prosthetic valve comprises the end portion of the inner surface.

[0400] Example 7: The prosthetic valve according to any example herein, specifically the prosthetic valve of Example 6, wherein the end portion of the inner surface is coupled to the end portion of the outer surface.

[0401] Example 8: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 1 to 7, wherein the portion of the prosthetic valve includes a barrier layer adjacent to the one or more prosthetic valve leaflets.

[0402] Example 9: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 8, wherein the barrier layer is configured to reduce the spread of tissue formation or thrombus formation towards the one or more prosthetic valve leaflets.

[0403] Example 10: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 8 or Example 9, wherein the one or more prosthetic valve leaflets are coupled to the barrier layer.

[0404] Example 11: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 1 to 10, wherein the prosthetic valve has a proximal portion and a distal portion, the proximal portion is at the inflow of the prosthetic valve, and the distal portion is at the outflow of the prosthetic valve, and the portion of the prosthetic valve is located at the proximal portion of the prosthetic valve.

[0405] Example 12: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 11, wherein the portion of the prosthetic valve includes a skirt extending distally from the proximal edge of the prosthetic valve.

[0406] Example 13: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 1 to 12, wherein the one or more prosthetic valve leaflets are located within the flow channel of the prosthetic valve, and the portion of the prosthetic valve defines the flow channel.

[0407] Example 14: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 13, wherein the portion of the prosthetic valve includes a sleeve defining the flow channel.

[0408] Example 15: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 1 to 14, wherein the prosthetic valve is configured to be deployed to an autologous mitral valve or an autologous tricuspid valve.

[0409] Example 16: A method comprising: deploying a prosthetic valve to an autologous valve, the prosthetic valve comprising: one or more prosthetic valve leaflets, and a valve body supporting the one or more prosthetic valve leaflets, wherein at least a portion of the prosthetic valve comprises a material configured to reduce tissue formation or thrombus formation along the portion of the prosthetic valve.

[0410] Example 17: The method according to any example herein, specifically the method described in Example 16, wherein the one or more prosthetic valve leaflets are positioned within the flow channel of the prosthetic valve, and the prosthetic valve includes a valve body having an outer surface facing outward from the flow channel and an inner surface facing the flow channel, and the portion of the prosthetic valve includes the inner surface of the valve body.

[0411] Example 18: The method according to any example herein, specifically the method described in Example 17, wherein the outer surface includes an end portion, and the inner surface includes an end portion proximate to the end portion of the outer surface, and the portion of the prosthetic valve includes the end portion of the inner surface.

[0412] Example 19: The method according to any example herein, specifically the method described in Examples 16 to 18, wherein the portion of the prosthetic valve includes a barrier layer adjacent to the one or more prosthetic valve leaflets.

[0413] Example 20: The method according to any example herein, specifically the method described in Example 19, wherein the barrier layer is configured to reduce the spread of tissue formation or thrombus formation towards the one or more prosthetic valve leaflets.

[0414] Example 21: A prosthetic valve configured to be deployed into an autologous valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; and a valve body that supports the one or more prosthetic valve leaflets, wherein at least a portion of the prosthetic valve includes a frame having a rough surface.

[0415] Example 22: The prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 21, wherein the rough surface includes an unpolished surface that forms the surface roughness.

[0416] Example 23: The prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 22, wherein a portion of the frame adjacent to the rough surface is smooth.

[0417] Example 24: The prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 23, wherein the portion of the frame adjacent to the rough surface includes a polished surface.

[0418] Example 25: The prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 21 to 24, wherein the rough surface includes residues from the formation process of the frame.

[0419] Example 26: The prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 21 to 25, wherein the frame includes a shape memory material.

[0420] Example 27: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 21 to 26, wherein the frame comprises nitinol.

[0421] Example 28: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 27, wherein the rough surface comprises the unpolished surface roughness of the nitinol.

[0422] Example 29: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 21 to 28, wherein the rough surface comprises microstructures.

[0423] Example 30: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 21 to 29, wherein the rough surface comprises one or more voids in the surface of the frame.

[0424] Example 31: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 21 to 30, wherein the rough surface is configured to provide friction with a portion of the native valve.

[0425] Example 32: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 21 to 31, wherein the rough surface is configured for tissue ingrowth with the frame.

[0426] Example 33: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 21 to 32, wherein the frame comprises a portion for forming a seal with the native valve to seal the body.

[0427] Example 34: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 21 to 33, wherein the frame comprises one or more anchors having the rough surface.

[0428] Example 35: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 21 to 34, wherein the prosthetic valve is configured to be deployed to the native mitral valve or native tricuspid valve.

[0429] Example 36: A method comprising: deploying a prosthetic valve to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; and a valve body that supports the one or more prosthetic valve leaflets, wherein at least a portion of the prosthetic valve comprises a frame having a rough surface.

[0430] Example 37: The method according to any example herein, specifically the method described in Example 36, wherein the rough surface comprises an unpolished surface that forms surface roughness.

[0431] Example 38: The method according to any example herein, specifically the method described in Example 36 or Example 37, wherein the rough surface includes residues of the formation process of the frame.

[0432] Example 39: The method according to any example herein, specifically the method described in Examples 36 to 38, wherein the frame includes nitinol.

[0433] Example 40: The method according to any example herein, specifically the method described in Example 39, wherein the rough surface includes the unpolished surface roughness of the nitinol.

[0434] Example 41: A prosthetic valve configured to be deployed to an autologous valve having autologous valve leaflets, the prosthetic valve comprising: one or more prosthetic valve leaflets; a valve body that supports the one or more prosthetic valve leaflets, the valve body including one or more grasping features configured to be positioned radially medial to one or more of the autologous valve leaflets of the autologous valve; and one or more anchors configured to be positioned radially lateral to the one or more of the autologous valve leaflets of the autologous valve and to press the one or more of the autologous valve leaflets of the autologous valve toward the one or more grasping features to reduce movement of the one or more of the autologous valve leaflets of the autologous valve relative to the valve body.

[0435] Example 42: The prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 41, wherein the one or more grasping features are positioned on a sealing body configured to form a seal with the autologous valve.

[0436] Example 43: The prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 41 or Example 42, wherein the one or more grasping features are positioned on a frame of the valve body.

[0437] Example 44: The prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 41 to 43, wherein the one or more grasping features are configured to reduce axial movement of the one or more of the autologous valve leaflets of the autologous valve relative to the valve body.

[0438] Example 45: The prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 41 to 44, wherein the one or more grasping features include surface roughness of a frame.

[0439] Example 46: The prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 41 to 45, wherein the one or more grasping features include one or more protrusions.

[0440] Example 47: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 46, wherein the one or more protrusions extend from the frame of the valve body.

[0441] Example 48: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 46 or Example 47, wherein the one or more protrusions extend distally.

[0442] Example 49: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 41 to 48, wherein the one or more anchors are configured to press one or more of the native valve leaflets against one or more of the grasping features of the native valve leaflets, such that one or more of the native valve leaflets are deflected between the one or more grasping features and the one or more anchors.

[0443] Example 50: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 41 to 49, wherein each of the one or more anchors includes a tip configured to press one or more of the native valve leaflets against one or more of the grasping features of the native valve leaflets.

[0444] Example 51: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 50, wherein the tip includes a recess configured to receive the one or more grasping features.

[0445] Example 52: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 41 to 51, wherein the valve body includes a frame having a plurality of struts and openings between the struts, and each of the one or more anchors is configured to be circumferentially aligned with at least one of the openings.

[0446] Example 53: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 52, wherein the one or more grasping features include one or more protrusions extending from the frame towards at least one of the openings.

[0447] Example 54: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 41 to 53, wherein the valve body includes a distal portion and a proximal portion, and the one or more anchors extend from the distal portion of the valve body.

[0448] Example 55: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 41 - 54, wherein the one or more anchors are configured to extend above the distal tip of one of the native valve leaflets.

[0449] Example 56: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 41-55, wherein the one or more anchors are configured to hook around the native valve leaflets.

[0450] Example 57: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 41 to 56, wherein the valve body includes an inner valve body and an outer valve body surrounding the inner valve body, and the one or more grasping features are located on the outer valve body.

[0451] Example 58: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 41 to 57, wherein the one or more anchors are configured to press one or more of the native valve leaflets against the one or more grasping features to resist distal movement of the prosthetic valve.

[0452] Example 59: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 41 to 58, wherein the prosthetic valve includes a prosthetic mitral valve or a prosthetic tricuspid valve, and the one or more anchors are configured to press one or more of the native valve leaflets against the one or more grasping features to resist ventricular movement of the prosthetic valve.

[0453] Example 60: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 59, wherein the one or more anchors hook around the native valve leaflets to resist atrial movement of the prosthetic valve.

[0454] Example 61: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 41 to 60, wherein the valve body includes an outer frame, and at least one of the plurality of anchors has a tip located distally of the outer frame.

[0455] Example 62: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 61, wherein the tip of the at least one of the plurality of anchors projects to a radius that is the same as or less than the radius of the outer surface of the outer frame.

[0456] Example 63: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 61 or Example 62, wherein the outer frame includes a plurality of struts, openings are formed between the plurality of struts, and the tip of the at least one of the plurality of anchors is located within one of the openings.

[0457] Example 64: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 63, wherein the one opening among the openings is the most distal opening located between adjacent most distal struts among the plurality of struts.

[0458] Example 65: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 61 to 64, wherein the valve body includes a skirt, and the skirt is positioned radially inward of the tip of at least one of the plurality of anchors.

[0459] Example 66: A method comprising deploying a prosthetic valve to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; a valve body that supports the one or more prosthetic valve leaflets, the valve body including one or more grasping features configured to be positioned radially inward of one or more native valve leaflets of the native valve; and one or more anchors configured to be positioned radially outward of the one or more native valve leaflets of the native valve and to press the one or more native valve leaflets of the native valve toward the one or more grasping features to reduce movement of the one or more native valve leaflets of the native valve relative to the valve body.

[0460] Example 67: The method according to any example herein, specifically Example 66, wherein the one or more grasping features are positioned on a sealing body configured to form a seal with the native valve.

[0461] Example 68: The method according to any example herein, specifically Example 66 or Example 67, wherein the one or more grasping features are configured to reduce axial movement of the one or more native valve leaflets of the native valve relative to the valve body.

[0462] Example 69: The method according to any example herein, specifically Examples 66 to 68, wherein the one or more grasping features include surface roughness of a frame.

[0463] Example 70: The method according to any example herein, specifically Examples 66 to 69, wherein the one or more grasping features include one or more protrusions.

[0464] Example 71: A prosthetic valve configured to be deployed into a native valve having native valve leaflets, the prosthetic valve comprising: one or more prosthetic valve leaflets; a valve body that supports the one or more prosthetic valve leaflets; and one or more anchors that extend from the valve body and are configured to be positioned radially outside of one or more of the native valve leaflets of the native valve leaflets to capture one or more of the native valve leaflets of the native valve leaflets, and wherein at least a portion of the prosthetic valve comprises one or more gripping features configured to engage the surface of the native valve when one of the anchors fails to capture one or more of the native valve leaflets.

[0465] Example 72: The prosthetic valve according to any example herein, specifically example 71, wherein the one or more gripping features are configured to be positioned radially medial to one or more of the native valve leaflets when one of the anchors fails to capture one or more of the native valve leaflets.

[0466] Example 73: The prosthetic valve according to any example herein, specifically example 71 or example 72, wherein the one or more gripping features are positioned on one or more of the anchors.

[0467] Example 74: The prosthetic valve according to any example herein, specifically example 73, wherein the one or more gripping features on one of the anchors that captures one of the native valve leaflets of the native valve leaflets are configured to be positioned radially outside of the captured native valve leaflet.

[0468] Example 75: The prosthetic valve according to any example herein, specifically example 73 or example 74, wherein the one or more gripping features are positioned on a radially outwardly facing portion of one or more of the anchors.

[0469] Example 76: The prosthetic valve according to any example herein, specifically example 75, wherein the portion of one or more of the anchors is configured to face radially outward when the one or more anchors are deployed and to face radially inward when the one or more anchors are not deployed.

[0470] Example 77: The prosthetic valve according to any example herein, specifically examples 71 to 76, wherein the one or more gripping features are positioned on the valve body.

[0471] Example 78: The prosthetic valve according to any example herein, specifically example 77, wherein the one or more gripping features are configured to extend radially outward from the valve body.

[0472] Example 79: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 77 or Example 78, wherein the one or more grasping features are configured to project radially outward from the valve body to a greater radial distance than the one or more anchors.

[0473] Example 80: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 71 to 79, wherein the one or more grasping features include one or more protrusions configured to extend distally.

[0474] Example 81: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 71 to 80, wherein the one or more grasping features include one or more barbs.

[0475] Example 82: A prosthetic valve according to any example herein, specifically the prosthetic valve of Examples 71 to 81, wherein the one or more grasping features are configured to have greater resistance to a force in the proximal direction than to a force in the distal direction.

[0476] Example 83: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 71 to 82, wherein the anchors that fail to capture the one or more native valve leaflets are configured to be positioned radially medial to the one or more native valve leaflets.

[0477] Example 84: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 71 - 83, wherein the valve body includes a frame.

[0478] Example 85: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 71 - 84, wherein the valve body includes an inner valve body and an outer valve body.

[0479] Example 86: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 85, wherein the outer valve body includes a frame and a skirt covering the frame.

[0480] Example 87: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 71 to 86, wherein the valve body includes a distal portion and a proximal portion, and the one or more anchors extend from the distal portion of the valve body.

[0481] Example 88: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 71 - 87, wherein the one or more anchors are configured to extend above the distal tip of one of the native valve leaflets.

[0482] Example 89: A prosthetic valve according to any example herein, specifically the prosthetic valves described in examples 71 - 88, wherein the one or more anchors are configured to hook around the native valve leaflets.

[0483] Example 90: A prosthetic valve according to any example herein, specifically the prosthetic valves described in examples 71 to 89, wherein the prosthetic valve is configured to be deployed to a native mitral valve or a native tricuspid valve.

[0484] Example 91: A method comprising: deploying a prosthetic valve to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; a valve body that supports the one or more prosthetic valve leaflets; and one or more anchors that extend from the valve body and are configured to be positioned radially outside of one or more of the native valve leaflets to capture one or more of the native valve leaflets, and wherein at least a portion of the prosthetic valve comprises one or more grasping features configured to engage the surface of the native valve when one of the anchors fails to capture one or more of the native valve leaflets.

[0485] Example 92: The method according to any example herein, specifically example 91, wherein the one or more grasping features are configured to be positioned radially medial to one or more of the native valve leaflets when one of the anchors fails to capture one or more of the native valve leaflets.

[0486] Example 93: The method according to any example herein, specifically example 91 or example 92, wherein the one or more grasping features are positioned on one or more of the anchors.

[0487] Example 94: The method according to any example herein, specifically examples 91 to 93, wherein the one or more grasping features are positioned on the valve body.

[0488] Example 95: The method according to any example herein, specifically example 94, wherein the one or more grasping features are configured to extend radially outward from the valve body.

[0489] Example 96: A prosthetic valve configured to be deployed to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; and a valve body that supports the one or more prosthetic valve leaflets and has an outer surface, wherein the outer surface of the valve body comprises a channel for a pacemaker lead to pass through.

[0490] Example 97: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 96, wherein the outer surface of the valve body is configured to contact the native valve.

[0491] Example 98: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 96 or Example 97, wherein the outer surface of the valve body includes a sealing surface configured to form a seal with the native valve.

[0492] Example 99: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 96 to 98, wherein the passageway includes a recess in the outer surface of the valve body.

[0493] Example 100: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 96 to 99, wherein the valve body includes a frame having a plurality of struts and openings between the struts, and the passageway extends through at least one of the openings.

[0494] Example 101: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 100, wherein the passageway extends between at least two of the struts.

[0495] Example 102: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 96 to 101, wherein the valve body includes a skirt, and the passageway includes a recess in the skirt.

[0496] Example 103: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 96 to 102, further comprising a plurality of anchors for anchoring the valve body to the native valve, wherein the passageway is circumferentially positioned between two of the plurality of anchors.

[0497] Example 104: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 103, wherein the passageway is configured to be positioned between the outer surface of the valve body and the inner surface of the native valve.

[0498] Example 105: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 96 to 104, wherein the prosthetic valve is configured to be deployed to a native mitral valve or a native tricuspid valve.

[0499] Example 106: A method comprising: deploying a prosthetic valve to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; and a valve body that supports the one or more prosthetic valve leaflets and has an outer surface, wherein the outer surface of the valve body includes a passageway for a pacemaker lead to pass through.

[0500] Example 107: The method according to any example herein, specifically the method described in Example 106, wherein the outer surface of the valve body is configured to contact the native valve.

[0501] Example 108: The method according to any example herein, specifically the method described in Example 106 or Example 107, wherein the outer surface of the valve body includes a sealing surface configured to form a seal with the native valve.

[0502] Example 109: The method according to any example herein, specifically the method described in Examples 106 to 108, wherein the channel includes a recess in the outer surface of the valve body.

[0503] Example 110: The method according to any example herein, specifically the method described in Examples 106 to 109, wherein the valve body includes a frame having a plurality of struts and openings between the struts, and the channel extends through at least one of the openings.

[0504] Example 111: A prosthetic valve configured to be deployed to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; a valve body including: an inner frame that supports the one or more prosthetic valve leaflets and has a proximal portion and a distal portion; and an outer frame that is positioned radially outside the inner frame and has a proximal portion, a distal portion, and an outer surface that faces radially outward from the prosthetic valve, the proximal portion of the outer frame being coupled to the proximal portion of the inner frame, and the distal portion of the outer frame being spaced apart from the inner frame; and a plurality of anchors, each anchor being coupled to the inner frame and having a hook shape and extending radially outward from the inner frame, a first anchor of the plurality of anchors having a tip positioned radially outside the outer frame and overlapping the outer surface, and a second anchor of the plurality of anchors having a tip positioned distally of the outer frame and at least partially recessed radially inward from the outer surface.

[0505] Example 112: The prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 111, wherein the tip of the second anchor of the plurality of anchors projects to a radius that is the same as or less than the radius of the outer surface of the outer frame.

[0506] Example 113: The prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 111 or Example 112, wherein the outer frame includes a plurality of struts with openings formed therebetween, and the tip of the second anchor of the plurality of anchors is positioned within one of the openings.

[0507] Example 114: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 113, wherein one of the openings is the most distal opening positioned between the most distal struts among the plurality of struts.

[0508] Example 115: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 111 to 114, wherein the axial height reached by the tip of the second anchor among the plurality of anchors in the proximal direction of the prosthetic valve is less than the axial height reached by the tip of the first anchor among the plurality of anchors.

[0509] Example 116: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 111 to 115, wherein each of the plurality of anchors includes a falling loop, and the position of the falling loop of the second anchor among the plurality of anchors axially protrudes in the distal direction of the prosthetic valve relative to the falling loop of the first anchor among the plurality of anchors.

[0510] Example 117: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 111 to 116, wherein the valve body includes a skirt, and the skirt is positioned radially inward of the tip of the second anchor among the plurality of anchors.

[0511] Example 118: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 111 to 117, wherein the outer frame includes one or more grasping features configured to be positioned radially inward of one or more leaflets of the native valve, and the tip of the first anchor among the plurality of anchors overlaps with the one or more grasping features to press the one or more leaflets of the native valve toward the one or more grasping features to reduce movement of the one or more leaflets of the native valve relative to the valve body.

[0512] Example 119: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 111 to 118, wherein the plurality of anchors includes at least three anchors each having a tip positioned radially outside the outer frame and overlapping the outer surface, and the plurality of anchors includes at least two anchors each having a tip positioned distally of the outer frame.

[0513] Example 120: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 111 to 119, wherein the plurality of anchors includes at least four anchors each having a tip positioned radially outside the outer frame and overlapping the outer surface, and the plurality of anchors includes at least three anchors each having a tip positioned distally of the outer frame.

[0514] Example 121: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 111 to 120, wherein a first portion of the outer circumference of the prosthetic valve includes a plurality of anchors, each anchor having a tip positioned radially outside the outer frame and overlapping the outer surface, and a second portion of the outer circumference includes a plurality of anchors, each anchor having a tip positioned distally of the outer frame, wherein the first portion includes at least 180 degrees of the outer circumference.

[0515] Example 122: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 121, wherein the first portion includes at least 200 degrees of the outer circumference.

[0516] Example 123: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 111 to 122, wherein the outer frame has an oval outer profile.

[0517] Example 124: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 111 to 123, wherein each of the plurality of anchors is adapted to hook onto an autologous valve leaflet to anchor to the autologous valve.

[0518] Example 125: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 111 to 124, wherein the prosthetic valve includes a prosthetic mitral valve or a prosthetic tricuspid valve.

[0519] Example 126: A method comprising: deploying a prosthetic valve to an autologous valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; a valve body comprising: an inner frame that supports the one or more prosthetic valve leaflets and has a proximal portion and a distal portion; and an outer frame that is positioned radially outside the inner frame and has a proximal portion, a distal portion, and an outer surface that faces radially outward from the prosthetic valve, the proximal portion of the outer frame being coupled to the proximal portion of the inner frame, and the distal portion of the outer frame being spaced apart from the inner frame; and a plurality of anchors, each anchor being coupled to the inner frame and having a hook shape and extending radially outward from the inner frame, a first anchor of the plurality of anchors having a tip positioned radially outside the outer frame and overlapping the outer surface, and a second anchor of the plurality of anchors having a tip positioned distally of the outer frame and at least partially radially inwardly recessed from the outer surface.

[0520] Example 127: The method according to any example herein, specifically the method described in Example 126, wherein the tip of the second of the plurality of anchors protrudes to a radius that is the same as or less than the radius of the outer surface of the outer frame.

[0521] Example 128: The method according to any example herein, specifically the method described in Example 126 or Example 127, wherein the outer frame includes a plurality of struts, openings are formed between the plurality of struts, and the tip of the second of the plurality of anchors is positioned within one of the openings.

[0522] Example 129: The method according to any example herein, specifically the method described in Example 128, wherein the one opening is the outermost opening positioned between the outermost struts of the plurality of struts.

[0523] Example 130: The method according to any example herein, specifically the method described in Examples 126 to 129, wherein the axial height to which the tip of the second of the plurality of anchors extends in the proximal direction of the prosthetic valve is less than the axial height to which the tip of the first of the plurality of anchors extends.

[0524] Example 131: A prosthetic valve configured to be deployed to an autologous valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; a valve body that supports the one or more prosthetic valve leaflets; one or more hook arm anchors coupled to the valve body, and each hook arm anchor being adapted to hook a leaflet of the autologous valve to anchor to the autologous valve; and one or more snap anchors coupled to the valve body, and each snap anchor being adapted to snap a portion of the autologous valve to anchor to the autologous valve.

[0525] Example 132: The prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 131, wherein the valve body includes a radially outward-facing outer surface, and each of the one or more hook arm anchors protrudes radially outward from the outer surface of the valve body.

[0526] Example 133: The prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 131 or Example 132, wherein the valve body includes a radially outward-facing outer surface, and the one or more snap anchors are flush with the outer surface of the valve body.

[0527] Example 134: A prosthetic valve according to any of the examples herein, specifically the prosthetic valve described in Examples 131 to 133, wherein each of the one or more snap anchors has a tip with a circumferentially planar shape.

[0528] Example 135: A prosthetic valve according to any of the examples herein, specifically the prosthetic valve described in Examples 131 to 134, wherein each of the one or more snap anchors has a drop loop and is spring biased towards the valve body.

[0529] Example 136: A prosthetic valve according to any of the examples herein, specifically the prosthetic valve described in Examples 131 to 135, wherein the valve body includes a radially outward facing outer surface, and each of the one or more snap anchors is adapted to snap a portion of the leaflets of the native valve against the outer surface of the valve body.

[0530] Example 137: A prosthetic valve according to any of the examples herein, specifically the prosthetic valve described in Examples 131 to 136, wherein the valve body includes: an inner frame that supports the one or more prosthetic valve leaflets and has a proximal portion and a distal portion; and an outer frame that is positioned radially outside the inner frame and has a proximal portion, a distal portion, and an outer surface that faces radially outward from the prosthetic valve, the proximal portion of the outer frame being coupled to the proximal portion of the inner frame, and the distal portion of the outer frame being spaced apart from the inner frame by a gap; and the one or more snap anchors are coupled to the distal portion of the inner frame.

[0531] Example 138: A prosthetic valve according to any of the examples herein, specifically the prosthetic valve described in Examples 131 to 137, wherein the valve body includes: an inner frame that supports the one or more prosthetic valve leaflets and has a proximal portion and a distal portion; and an outer frame that is positioned radially outside the inner frame and has a proximal portion, a distal portion, and an outer surface that faces radially outward from the prosthetic valve, the proximal portion of the outer frame being coupled to the proximal portion of the inner frame, and the distal portion of the outer frame being spaced apart from the inner frame by a gap; and the one or more snap anchors are coupled to the distal portion of the outer frame.

[0532] Example 139: A prosthetic valve according to any of the examples herein, specifically the prosthetic valve described in Examples 131 to 138, wherein the valve body includes one or more grasping features configured to be positioned radially medial to one or more leaflets of the native valve.

[0533] Example 140: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 139, wherein the one or more snap anchors overlap with the one or more grasping features to press one or more leaflets of the native valve toward the one or more grasping features to reduce movement of the one or more leaflets of the native valve relative to the valve body.

[0534] Example 141: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 139 or Example 140, wherein the one or more hook arm anchors overlap with the one or more grasping features to press one or more leaflets of the native valve toward the one or more grasping features to reduce movement of the one or more leaflets of the native valve relative to the valve body.

[0535] Example 142: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 131 to 141, wherein the one or more snap anchors include at least two snap anchors among the snap anchors.

[0536] Example 143: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 131 to 142, wherein a first portion of the outer circumference of the prosthetic valve includes the one or more hook arm anchors, and a second portion of the outer circumference includes the one or more snap anchors, wherein the first portion includes at least 180 degrees of the outer circumference.

[0537] Example 144: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 143, wherein the first portion includes at least 200 degrees of the outer circumference.

[0538] Example 145: A prosthetic valve according to any example herein, specifically the prosthetic valves described in Examples 131 to 144, wherein the prosthetic valve includes a prosthetic mitral valve or a prosthetic tricuspid valve.

[0539] Example 146: A method that includes: deploying a prosthetic valve to a native valve, the prosthetic valve including: one or more prosthetic valve leaflets; a valve body that supports the one or more prosthetic valve leaflets; one or more hook arm anchors that are coupled to the valve body and each of which is adapted to hook a leaflet of the native valve to anchor to the native valve; and one or more snap anchors that are coupled to the valve body and each of which is adapted to snap a portion of the native valve to anchor to the native valve.

[0540] Example 147: The method according to any example herein, specifically the method described in Example 146, wherein the valve body includes a radially outward-facing outer surface, and each of the one or more hook arm anchors projects radially outward from the outer surface of the valve body.

[0541] Example 148: The method according to any example herein, specifically the method described in Example 146 or Example 147, wherein the valve body includes a radially outward-facing outer surface, and the one or more snap anchors are flush with the outer surface of the valve body.

[0542] Example 149: The method according to any example herein, specifically the method described in Examples 146 to 148, wherein each of the one or more snap anchors has a tip with a circumferentially planar shape.

[0543] Example 150: The method according to any example herein, specifically the method described in Examples 146 to 149, wherein each of the one or more snap anchors has a drop loop and is spring biased towards the valve body.

[0544] Example 151: A prosthetic valve configured to be deployed to an autologous valve between an atrium and a ventricle, the prosthetic valve comprising: one or more prosthetic valve leaflets; a valve body that supports the one or more prosthetic valve leaflets and has a proximal portion and a distal portion; one or more hook arm anchors coupled to the valve body, and each hook arm anchor being adapted to hook a leaflet of the autologous valve to anchor to the autologous valve; and one or more support arms coupled to the valve body, and each support arm having a proximal portion coupled to the valve body and a distal portion that projects from the valve body in a distal direction and is configured to extend into the ventricle, the one or more support arms being adapted to stabilize the prosthetic valve within the autologous valve.

[0545] Example 152: The prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 151, wherein the one or more support arms include at least two of the support arms.

[0546] Example 153: The prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 151 or Example 152, wherein the one or more support arms axially extend in a distal direction to the tip of the respective support arm.

[0547] Example 154: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 151 to 153, wherein the valve body comprises: an inner frame that supports the one or more prosthetic valve leaflets and has a proximal portion and a distal portion; and an outer frame that is positioned radially outside the inner frame and has a proximal portion and a distal portion, the proximal portion of the outer frame being coupled to the proximal portion of the inner frame, and the distal portion of the outer frame being spaced apart from the inner frame by a gap.

[0548] Example 155: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 154, wherein the one or more support arms are coupled to the distal portion of the inner frame.

[0549] Example 156: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 154 or Example 155, wherein the one or more hook arm anchors are coupled to the distal portion of the inner frame.

[0550] Example 157: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 151 to 156, wherein the one or more hook arm anchors are positioned on a first portion of the valve body that extends at least 180 degrees around the outer circumference of the prosthetic valve, and the one or more support arms are positioned on a second portion of the valve body that is opposite the first portion.

[0551] Example 158: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 157, wherein the first portion of the valve body extends at least 200 degrees around the outer circumference.

[0552] Example 159: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 157 or Example 158, wherein the second portion of the valve body does not have any hook arm anchors.

[0553] Example 160: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 157 to 159, wherein the prosthetic valve is a prosthetic tricuspid valve, and the second portion is adapted to face the septal side of the native tricuspid valve.

[0554] Example 161: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Examples 157 to 160, wherein the second portion of the valve body has an outer surface that faces radially outward and comprises friction elements for providing friction with the native valve.

[0555] Example 162: A prosthetic valve according to any example herein, specifically the prosthetic valve described in Example 161, wherein the friction elements comprise barbs that extend parallel to the plane of the outer surface of the valve body.

[0556] Example 163: A prosthetic valve as described in any example herein, specifically the prosthetic valve described in Example 161 or Example 162, wherein the friction element comprises barbed sheets.

[0557] Example 164: A prosthetic valve as described in any example herein, specifically the prosthetic valve described in Example 163, wherein the barbed sheets comprise arms defining one or more openings.

[0558] Example 165: A prosthetic valve as described in any example herein, specifically the prosthetic valve described in Examples 151 to 164, wherein the one or more support arms are adapted to contact the inner wall of the ventricle to stabilize the prosthetic valve within the native valve, and the one or more support arms comprise piercing elements for piercing the heart wall of the ventricle to fix the one or more support arms to the heart wall.

[0559] Example 166: A method comprising: deploying a prosthetic valve into a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; a valve body that supports the one or more prosthetic valve leaflets and has a proximal portion and a distal portion; one or more hook arm anchors coupled to the valve body, and each hook arm anchor being adapted to hook a leaflet of the native valve to anchor to the native valve; and one or more support arms coupled to the valve body, and each support arm having a proximal portion coupled to the valve body and a distal portion that projects distally from the valve body and is configured to extend into the ventricle, the one or more support arms being adapted to stabilize the prosthetic valve within the native valve.

[0560] Example 167: The method as described in any example herein, specifically the method described in Example 166, wherein the one or more support arms comprise at least two of the support arms.

[0561] Example 168: The method as described in any example herein, specifically the method described in Example 166 or Example 167, wherein the one or more support arms axially extend in a distal direction to the tip of the respective support arm.

[0562] Example 169: The method as described in any example herein, specifically the method described in Examples 166 to 168, wherein the valve body comprises: an inner frame that supports the one or more prosthetic valve leaflets and has a proximal portion and a distal portion; and an outer frame that is positioned radially outside the inner frame and has a proximal portion and a distal portion, the proximal portion of the outer frame being coupled to the proximal portion of the inner frame, and the distal portion of the outer frame being spaced apart from the inner frame by a gap.

[0563] Example 170: According to any example herein, specifically the method described in Example 169, wherein the one or more support arms are coupled to the distal portion of the inner frame.

[0564] Any feature of any example, including but not limited to any of the first through 170 examples mentioned above, applies to all other aspects and examples identified herein, including but not limited to any of the first through 170 examples mentioned above. Additionally, features of examples within various examples, including but not limited to any of the first through 170 examples mentioned above, may be combined in whole or in part with other examples described herein in any manner, e.g., one, two, or three or more examples may be combined in whole or in part. Further, features of various examples, including but not limited to any of the first through 170 examples mentioned above, may be made optional in other examples. Any example of a method may be performed by a system or device of another example, and any aspect or example of a system or device may be configured to perform another aspect or example, including but not limited to the method of any of the first through 170 examples mentioned above.

[0565] Finally, it should be understood that although aspects of this specification are highlighted by reference to specific examples, those skilled in the art will readily appreciate that these disclosed examples are merely illustrative of the principles of the subject matter disclosed herein. Accordingly, it should be understood that the disclosed subject matter is in no way limited to the specific methods, schemes, and / or reagents, etc. described herein. Thus, various modifications or alterations or alternative configurations may be made to the disclosed subject matter in accordance with the teachings herein without departing from the spirit of this specification. Finally, the terms used herein are for the purpose of describing particular examples only and are not intended to limit the scope of the systems, devices, and methods disclosed herein, which scope is defined only by the claims. Accordingly, the systems, devices, and methods are not limited to the exact details shown and described.

[0566] Certain examples of systems, devices, and methods are described herein, including the best mode known to the inventors for carrying out these examples. Of course, variations of these described examples will become apparent to those of ordinary skill in the art after reading the foregoing description. The inventors expect skilled artisans to employ such variations appropriately, and the inventors intend for the systems, devices, and methods to be practiced otherwise than as specifically described herein. Accordingly, the systems, devices, and methods include all modifications and equivalents of the subject matter recited in the appended claims as permitted by applicable law. Additionally, unless otherwise stated herein or clearly contradicted by context, the systems, devices, and methods cover any combination of the above examples in all possible variations thereof.

[0567] Groupings of alternative examples, elements, or steps of the system, apparatus, and method should not be construed as limiting. Each member of a group can be referred to and claimed individually or in any combination with other members disclosed herein. For purposes of convenience and / or patentability, it is anticipated that one or more members of a group can be included in or deleted from the group. When any such inclusion or deletion is made, the specification is to be regarded as including the modified group in order to satisfy the written description of all Markush groups used in the appended claims.

[0568] Unless otherwise indicated, all numbers expressing features, items, quantities, parameters, properties, terms, etc., used in this specification and the claims are to be understood as being modified in all instances by the term "about." As used herein, the term "about" means that the feature, item, quantity, parameter, property, or term so qualified covers approximations that can vary but which are capable of performing the desired operation or process discussed herein.

[0569] Unless otherwise stated herein or clearly contradicted by context, the terms "a," "an," "the," and similar designators used in the context of describing the system, apparatus, and method (especially in the context of the following claims) are to be construed to cover the singular and the plural. Unless otherwise stated herein or otherwise clearly contradicted by context, all methods described herein can be performed in any suitable order. The use of any and all examples, or exemplary language (e.g., "such as") provided herein is merely intended to better illuminate the system, apparatus, and method and does not pose a limitation on the scope of the system, apparatus, and method being claimed. No language in this specification should be construed as indicating any unclaimed element essential to the practice of the system, apparatus, and method.

[0570] All patents, patent publications, and other publications cited and identified in this specification are hereby incorporated by reference in their entirety, individually and expressly, for the purpose of describing and disclosing, for example, the compositions and methods described in such publications that may be used in connection with the system, apparatus, and method. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regard should be construed as an admission that the inventors are entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or content of these documents are based on the information available to the applicant and do not constitute any admission as to the correctness of the date or content of these documents.

Claims

1. A prosthetic heart valve for replacing the function of an autologous heart valve, the prosthetic heart valve comprising: A self-expanding frame sized to be deployed within the autologous heart valve, the frame having an outer surface for pressing against the tissue of the autologous heart valve; A plurality of prosthetic valve leaflets positioned within the interior of the frame, the leaflets configured to permit flow in a first direction and prevent flow in a second direction; A fabric skirt covering at least a portion of the outer surface of the frame; And A plurality of ventricular anchors extending from a downstream portion of the frame and shaped to capture an autologous leaflet of the autologous heart valve between the anchors and the outer surface of the frame; Wherein a plurality of barbs are provided along the outer surface of the frame, and wherein the ventricular anchors press the autologous leaflets against the barbs to secure the prosthetic heart valve within the autologous heart valve.

2. The prosthetic heart valve according to claim 1, wherein the self-expanding frame includes an inner frame for supporting the prosthetic valve leaflets and an outer frame for sealing against the tissue of the autologous heart valve.

3. The prosthetic heart valve according to claim 2, wherein the barbs are located on the outer frame and sized to extend through the fabric skirt to penetrate the tissue of the autologous heart valve.

4. The prosthetic heart valve according to claim 2 or claim 3, wherein the inner frame is coupled to the outer frame via an intermediate member to permit movement of the inner frame relative to the outer frame.

5. The prosthetic heart valve according to any one of claims 2 to 4, wherein the barbs are located only along a downstream portion of the outer frame.

6. The prosthetic heart valve according to any one of claims 2 to 5, wherein the inner frame has a substantially hourglass shape.

7. The prosthetic heart valve according to any one of claims 2 to 6, wherein the outer frame has a tapered shape such that a downstream portion of the outer frame has a smaller diameter than a middle portion of the outer frame.

8. The prosthetic heart valve according to claim 7, wherein the middle portion of the outer frame has a diameter in the range of about 35 mm to 60 mm.

9. The prosthetic heart valve according to any one of claims 2 to 8, wherein the outer frame is more flexible than the inner frame, and wherein the outer frame is adapted to conform to the shape of the autologous heart valve.

10. The prosthetic heart valve according to any one of claims 2 to 9, wherein the outer surface of the outer frame includes a plurality of axially extending concave recesses spaced about the outer surface and adapted to receive a respective one of the ventricular anchors.

11. The prosthetic heart valve according to any one of claims 2 to 10, wherein the inner frame comprises a first frame coupled to a second frame, the first frame comprising struts and surrounding a flow passage of the prosthetic heart valve, the second frame comprising struts of the plurality of ventricular anchors, and a radial thickness of the struts of the plurality of ventricular anchors being less than a radial thickness of the struts of the first frame.

12. The prosthetic heart valve according to any one of claims 1 to 11, wherein the prosthetic valve leaflets are made of pericardium.

13. The prosthetic heart valve according to any one of claims 1 to 12, wherein the self-expanding frame is made of a shape memory material.

14. The prosthetic heart valve according to any one of claims 1 to 13, further comprising eyelets disposed along an upstream portion of the frame for receiving sutures, and wherein the prosthetic heart valve can be retrieved after deployment by applying tension to the sutures.

15. The prosthetic heart valve according to any one of claims 1 to 14, wherein the self-expanding frame comprises a plurality of struts forming expandable and collapsible units, and wherein the barbs are disposed along the struts.

16. The prosthetic heart valve according to any one of claims 1 to 15, wherein tips of the plurality of ventricular anchors are at least partially recessed radially inwardly from an outer surface of the prosthetic heart valve to press against the tissue of the native heart valve.

17. The prosthetic heart valve according to claim 16, wherein the frame comprises a plurality of struts with openings formed therebetween, and a tip of one of the plurality of anchors is positioned distal to a most distal strut of the frame and within one of the openings.

18. The prosthetic heart valve according to any one of claims 1 to 17, wherein the ventricular anchors are spaced apart from each other unequally.

19. The prosthetic heart valve according to any one of claims 1 to 18, wherein the plurality of ventricular anchors comprise latches radially biased inwardly by springs.

20. The prosthetic heart valve according to claim 19, wherein a first portion of an outer circumference of the prosthetic heart valve comprises the latches, and a second portion of the outer circumference opposite the first portion comprises hook arm anchors.

21. The prosthetic heart valve according to any one of claims 1 to 20, further comprising one or more support arms coupled to the frame, and each support arm having a proximal portion coupled to the frame and a distal portion projecting from the frame in an axially distal direction and adapted to extend into a ventricle, the one or more support arms being adapted to stabilize the prosthetic heart valve within the native heart valve.

22. The prosthetic heart valve according to any one of claims 1 to 21, wherein at least a portion of the prosthetic heart valve comprises one or more grasping features for engaging a surface of the native heart valve when one of the ventricular anchors fails to capture one or more of the native leaflets.

23. The prosthetic heart valve according to any one of claims 1 to 22, wherein an outer surface of the prosthetic heart valve includes a passage for a pacemaker lead to pass through.

24. The prosthetic heart valve according to any one of claims 1 to 23, wherein the frame has an unpolished surface formed with a surface roughness to engage the native leaflets.

25. The prosthetic heart valve according to any one of claims 1 to 24, wherein the prosthetic heart valve is sized for replacement of a native tricuspid valve or mitral valve.

26. A prosthetic valve configured to be deployed to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; a valve body, the valve body comprising: an inner frame that supports the one or more prosthetic valve leaflets and has a proximal portion and a distal portion, and an outer frame that is positioned radially outside of the inner frame and has a proximal portion, a distal portion, and an outer surface that faces radially outward from the prosthetic valve, the proximal portion of the outer frame being coupled to the proximal portion of the inner frame, and the distal portion of the outer frame being spaced apart from the inner frame by a gap; and a plurality of anchors, each anchor being coupled to the inner frame and having a hook shape and extending radially outward from the inner frame, a first anchor of the plurality of anchors having a tip positioned radially outside of the outer frame and overlapping the outer surface, and a second anchor of the plurality of anchors having a tip positioned distally of the outer frame and at least partially recessed radially inward from the outer surface.

27. The prosthetic valve according to claim 26, wherein the tip of the second anchor of the plurality of anchors projects to a radius that is the same as or less than the radius of the outer surface of the outer frame.

28. The prosthetic valve according to claim 26 or claim 27, wherein the outer frame includes a plurality of struts with openings formed therebetween, and the tip of the second anchor of the plurality of anchors is positioned within one of the openings.

29. The prosthetic valve according to claim 28, wherein the one opening is a distal opening positioned between adjacent distal-most struts of the plurality of struts.

30. The prosthetic valve according to any one of claims 26 to 29, wherein an axial height to which the tip of the second anchor of the plurality of anchors extends in a proximal direction of the prosthetic valve is less than an axial height to which the tip of the first anchor of the plurality of anchors extends.

31. A prosthetic valve configured to be deployed to a native valve between an atrium and a ventricle, the prosthetic valve comprising: one or more prosthetic valve leaflets; a valve body that supports the one or more prosthetic valve leaflets and has a proximal portion and a distal portion; one or more hook-arm anchors coupled to the valve body, and each hook-arm anchor being adapted to hook a leaflet of the native valve to anchor to the native valve; and one or more support arms, the one or more support arms being coupled to the valve body, and each support arm having a proximal portion coupled to the valve body and a distal portion projecting from the valve body in a distal direction and configured to extend into the ventricle, the one or more support arms being adapted to stabilize the prosthetic valve within the native valve.

32. The prosthetic valve according to claim 31, wherein the one or more hook arm anchors are positioned on a first portion of the valve body extending at least 180 degrees of the outer circumference of the prosthetic valve, and the one or more support arms are positioned on a second portion of the valve body opposite the first portion.

33. The prosthetic valve according to claim 31 or claim 32, wherein the second portion of the valve body has a radially outwardly facing outer surface and includes friction elements for providing friction with the native valve.

34. The prosthetic valve according to any one of claims 31 to 33, wherein the one or more support arms are adapted to contact the inner wall of the ventricle to stabilize the prosthetic valve within the native valve.

35. The prosthetic valve according to any one of claims 31 to 34, wherein the one or more support arms include piercing elements for piercing the heart wall of the ventricle to secure the one or more support arms to the heart wall.

Images