artificial valve

Abstract

The prosthetic heart valve includes a self-expanding frame and a plurality of prosthetic leaflets positioned within the frame. A ventricular anchor extends from a downstream portion of the frame and is shaped to capture the native valve leaflets. Barbs are preferably provided along the outer surface of the frame to enhance fixation. The self-expanding frame may include an inner frame for supporting the prosthetic leaflets and an outer frame for sealing against the tissue of the native heart valve. The inner and outer frames may be attached via a flexible intermediate component, which may allow the inner frame to move relative to the outer frame. The outer frame may be more flexible than the inner frame, and may include axial recesses for receiving the ventricular anchors, which may reduce the profile after implantation. The prosthetic heart valve is preferably sized to replace a native tricuspid valve.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 436,051, filed December 29, 2022, and U.S. Provisional Application No. 63 / 533,458, filed August 18, 2023, the entire contents of each of which are incorporated herein by reference.

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

[0003] Human heart valves, including the aortic, pulmonary, mitral, and tricuspid valves, essentially function as one-way valves that operate in sync with the heartbeat. The valves allow blood to flow downstream but prevent blood from flowing upstream. Affected heart valves exhibit defects such as valve stenosis or regurgitation, which impair the valve's ability to control blood flow. Such defects reduce the heart's blood-pumping efficiency and can lead to debilitating and life-threatening conditions. For example, valve malfunction can lead to symptoms such as cardiac hypertrophy and ventricular dilation. Accordingly, considerable efforts have been made to develop methods and devices for repairing or replacing malfunctioning heart valves.

[0004] Prosthetic valves exist to correct problems associated with dysfunctional heart valves. For example, mechanical, tissue-based prosthetic heart valves can be used to replace dysfunctional native heart valves. Recently, significant efforts have been made to develop replacement heart valves, particularly tissue-based heart valve replacements, that can be delivered with less trauma to the patient compared to open-heart surgery. Replacement valves are designed to be delivered via minimally invasive, and even percutaneous, procedures. Such replacement valves often include prosthetic leaflets connected to an expandable frame and subsequently delivered to the native valve annulus.

[0005] The development of prosthetic valves, including but not limited to replacement heart valves that can be miniaturized for delivery and then controllably expanded for controlled deployment, has proven particularly challenging. An additional challenge relates to the ability to secure such prosthetic valves to endoluminal tissue, such as tissue within any lumen or cavity of the body, in an atraumatic manner.

[0006] Delivering a prosthetic valve to a desired site within the human body can also be difficult, such as delivering a replacement heart valve to a mitral valve. To achieve access to perform procedures within the heart or other anatomical sites, it may be necessary to deliver the device percutaneously through a tortuous vascular system or by open or semi-open surgical procedures. The ability to control the deployment of the prosthetic valve at the desired site can also be difficult. Summary of the Invention [Means for solving the problem]

[0007] Examples of the present disclosure may be directed to implants, which may include prosthetic devices such as, but not limited to, replacement heart valves. The replacement heart valves may include replacement mitral or tricuspid heart valves. In some examples, replacement heart valves are provided, and methods for delivering the replacement heart valves relative to native heart valves, such as the mitral, aortic, or tricuspid valves, are provided.

[0008] Disclosed herein may be improved anchoring of a prosthetic valve to a native implantation site. Improved interaction between tissue at the native implantation site and the prosthetic valve may be provided. Provided herein may be a prosthetic heart valve configuration for accommodating a pacemaker lead.

[0009] An example of the present disclosure may include a prosthetic heart valve for replacing the function of a native heart valve. The prosthetic heart valve may include a self-expanding frame sized for deployment inside the native heart valve, the self-expanding frame having an outer surface for pressing against tissue of the native heart valve. The prosthetic heart valve may include a plurality of prosthetic leaflets positioned inside the frame, the prosthetic leaflets configured to allow flow in a first direction and block 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, the plurality of ventricular anchors shaped to capture the native leaflets of the native 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 secure the prosthetic heart valve inside the native heart valve by pressing the native leaflets against the barbs.

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

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

[0012] Examples of the present disclosure may include a prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve may include one or more prosthetic leaflets and a valve body supporting the one or more prosthetic leaflets, at least a portion of the prosthetic valve including a frame having a roughened surface.

[0013] Examples of the present disclosure may include a method. The method may include deploying a prosthetic valve relative to a native valve. The prosthetic valve may include one or more prosthetic leaflets and a valve body supporting the one or more prosthetic leaflets, at least a portion of the prosthetic valve including a frame having a roughened surface.

[0014] Examples of the present disclosure may include a prosthetic valve configured to be deployed relative to a native valve having native leaflets, the prosthetic valve may include one or more prosthetic leaflets, a valve body supporting the one or more prosthetic leaflets, the valve body including one or more gripping features configured to be positioned radially inward of the one or more native leaflets, and one or more anchors configured to be positioned radially outward of one or more of the native leaflets, the anchors configured to press the one or more native leaflets against the one or more gripping features, thereby reducing movement of the one or more native leaflets relative to the valve body.

[0015] Examples of the present disclosure may include a method. The method may include deploying a prosthetic valve relative to a native valve. The prosthetic valve may include one or more prosthetic leaflets, a valve body supporting the one or more prosthetic leaflets, the valve body including one or more gripping features configured to be positioned radially inward of the one or more native leaflets, and one or more anchors configured to be positioned radially outward of one or more of the native leaflets, the anchors configured to press the one or more native leaflets against the one or more gripping features, thereby reducing movement of the one or more native leaflets relative to the valve body.

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

[0017] Examples of the present disclosure may include a method. The method may include deploying a prosthetic valve relative to a native valve. The prosthetic valve may include one or more prosthetic leaflets, a valve body supporting the one or more prosthetic leaflets, and one or more anchors extending from the valve body, the one or more anchors configured to capture one or more of the native valve leaflets by being positioned radially outward of 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 a surface of the native valve when an anchor fails to capture one or more native valve leaflets.

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

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

[0020] Examples of the present disclosure may include a prosthetic valve configured to be deployed relative to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets and a valve body. The valve body may include an inner frame supporting the one or more prosthetic valve leaflets, the inner frame having a proximal end portion and a distal end portion, and an outer frame positioned radially outward from the inner frame, the outer frame having a proximal end portion, a distal end portion, and an outer surface facing radially outward from the prosthetic valve, the proximal end portion of the outer frame being coupled to the proximal end portion of the inner frame and the distal end portion of the outer frame being spaced apart from the inner frame by a gap. The prosthetic valve may include a plurality of anchors each coupled to an inner frame, the anchors 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 outward from the outer frame and overlapping with respect to the outer surface, and a second anchor of the plurality of anchors having a tip positioned distally from 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 relative to a native valve. The prosthetic valve may include a valve body including one or more prosthetic leaflets, an inner frame being a valve body and supporting the one or more prosthetic leaflets, the inner frame having a proximal end portion and a distal end portion, and an outer frame positioned radially outward from the inner frame, the outer frame having a proximal end portion and a distal end portion and an outer surface facing radially outward from the prosthetic valve, the proximal end portion of the outer frame being coupled to the proximal end portion of the inner frame and the distal end portion of the outer frame being spaced apart from the inner frame by a gap; and a plurality of anchors each coupled to the inner frame, the plurality of anchors having a hook shape and extending radially outward from the inner frame, wherein a first anchor of the plurality of anchors has a tip positioned radially outward from the outer frame and has a tip that overlaps with the outer surface, and a second anchor of the plurality of anchors has a tip positioned distal to the outer frame and has a tip that is 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 relative to a native 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 adapted to anchor to the native valve by hooking onto the leaflets of the native valve, and one or more clasp anchors coupled to the valve body, each adapted to anchor to the native valve by clamping a portion of the native valve.

[0023] Examples of the present disclosure may include a method. The method may include deploying a prosthetic valve relative to a native valve. The prosthetic valve may include one or more prosthetic leaflets, a valve body supporting the one or more prosthetic leaflets, one or more hook arm anchors coupled to the valve body, each adapted to anchor to the native valve by hooking onto the leaflets of the native valve, and one or more clasp anchors coupled to the valve body, each adapted to anchor to the native valve by clamping a portion of the native valve.

[0024] Examples of the present disclosure may include a prosthetic valve configured to be deployed relative to a native valve. The prosthetic valve may include one or more prosthetic leaflets and a valve body supporting the one or more prosthetic leaflets, the valve body having a proximal end portion and a distal end portion. The prosthetic valve may also include one or more hook arm anchors coupled to the valve body, each adapted to anchor to the native valve by hooking onto the leaflets of the native valve, and one or more support arms coupled to the valve body, each having a proximal end portion coupled to the valve body and a distal end portion protruding distally from the valve body and configured to extend into the ventricle, and further adapted to stabilize the prosthetic valve within the native valve.

[0025] Examples of the present disclosure may include a method. The method may include deploying a prosthetic valve relative to a native valve. The prosthetic valve may include one or more prosthetic leaflets, a valve body supporting the one or more prosthetic leaflets, the valve body having a proximal end portion and a distal end portion, one or more hook arm anchors coupled to the valve body, each adapted to anchor to the native valve by hooking onto the leaflets of the native valve, and one or more support arms coupled to the valve body, each having a proximal end portion coupled to the valve body and a distal end portion protruding distally from the valve body and configured to extend into a ventricle, and further adapted to stabilize the prosthetic valve within the native valve. [Brief explanation of the drawings]

[0026] [Figure 1] FIG. 1 shows a perspective view of a prosthetic valve. [Figure 2] FIG. 2 shows a cross-sectional schematic view of the prosthetic valve shown in FIG. [Figure 3] FIG. 3 shows a perspective view of a barrier layer for a prosthetic valve leaflet. [Figure 4] FIG. 4 shows a top perspective view of a barrier layer bonded to the inner frame of a prosthetic valve. [Figure 5A] FIG. 5A illustrates a cross-sectional schematic of a prosthetic valve deployed relative to an implantation site. [Figure 5B] FIG. 5B illustrates a cross-sectional schematic of the prosthetic valve deployed relative to the implantation site. [Figure 6] FIG. 6 illustrates a cross-sectional schematic view of a prosthetic valve deployed relative to an implantation site. [Figure 7A] FIG. 7A illustrates a perspective view of the skirt. [Figure 7B] FIG. 7B illustrates a cross-sectional side view of the skirt shown in FIG. 7A. [Figure 7C]FIG. 7C illustrates a proximal perspective view of the skirt shown in FIG. 7A coupled to the outer skirt of a prosthetic valve. [Figure 7D] FIG. 7D illustrates a distal perspective view of the skirt shown in FIG. 7A coupled to the outer skirt of a prosthetic valve. [Figure 7E] FIG. 7E illustrates a distal perspective view of the skirt shown in FIG. 7A coupled to a frame. [Figure 7F] FIG. 7F illustrates a cross-sectional side view of the wall of the skirt shown in FIG. 7A. [Figure 7G] FIG. 7G illustrates a side cross-sectional view of the prosthetic valve including the skirt shown in FIG. 7A. [Figure 8] FIG. 8 illustrates a perspective view of a frame for a prosthetic valve. [Figure 9] FIG. 9 illustrates a perspective view of the outer frame shown in FIG. 8 separated from the inner frame shown in FIG. [Figure 10] FIG. 10 illustrates a perspective view of the inner frame shown in FIG. 8 separated from the outer frame shown in FIG. [Figure 11] FIG. 11 illustrates a perspective view of the prosthetic valve. [Figure 12] FIG. 12 illustrates a plan view of a portion of the frame of the prosthetic valve. [Figure 13] FIG. 13 shows a detailed view of the portion of the frame circled in FIG. [Figure 14] FIG. 14 illustrates a schematic cross-sectional side view of a portion of the frame shown in FIG. [Figure 15] FIG. 15 illustrates a perspective view of a portion of the frame. [Figure 16] FIG. 16 illustrates a schematic cross-sectional side view of a portion of the frame shown in FIG. [Figure 17] FIG. 17 illustrates a perspective view of a portion of the frame. [Figure 18] FIG. 18 illustrates a schematic cross-sectional side view of a portion of the frame shown in FIG. [Figure 19]FIG. 19 illustrates a plan view of a portion of the frame of the prosthetic valve. [Figure 20] FIG. 20 illustrates a cross-sectional side view of the prosthetic valve deployed relative to the implantation site. [Figure 21A] FIG. 21A illustrates a plan view of the position of the anchor relative to the gripping feature. [Figure 21B] FIG. 21B illustrates a side cross-sectional schematic view of the anchor location shown in FIG. 21A. [Figure 22A] FIG. 22A illustrates a cross-sectional schematic of a prosthetic valve deployed relative to a native valve. [Figure 22B] FIG. 22B illustrates a cross-sectional schematic view of the prosthetic valve shown in FIG. 22A deployed relative to the native valve. [Figure 23] FIG. 23 illustrates a plan view of a portion of the frame of the prosthetic valve. [Figure 24A] FIG. 24A illustrates a plan view of the position of the anchor relative to the gripping feature. [Figure 24B] FIG. 24B illustrates a side cross-sectional schematic view of the anchor location shown in FIG. 24A. [Figure 25] FIG. 25 illustrates a plan view of a portion of the frame of the prosthetic valve. [Figure 26] FIG. 26 illustrates a perspective view of a portion of the frame of a prosthetic valve. [Figure 27] FIG. 27 illustrates a perspective view of an anchor positioned relative to a gripping feature. [Figure 28] FIG. 28 illustrates a side view of the anchor positioned relative to the gripping feature. [Figure 29A] FIG. 29A illustrates a side view of a frame including multiple gripping features. [Figure 29B] FIG. 29B illustrates a side cross-sectional view of an anchor positioned against one of the gripping features shown in FIG. 29A. [Figure 30A] FIG. 30A illustrates a perspective view of the prosthetic valve. [Figure 30B] FIG. 30B illustrates a side cross-sectional view of the anchor positioned against one of the grasping features of the prosthetic valve shown in FIG. 30A. [Figure 31] FIG. 31 illustrates a side cross-sectional view of the prosthetic valve shown in FIG. 30A deployed relative to the native valve. [Figure 32] FIG. 32 illustrates a distal perspective view of the prosthetic valve. [Figure 33] FIG. 33 illustrates a cross-sectional schematic of the prosthetic valve deployed relative to the native valve. [Figure 34] FIG. 34 illustrates a cross-sectional schematic view of a prosthetic valve positioned within a capsule in an undeployed configuration. [Figure 35] FIG. 35 illustrates a perspective view of the prosthetic valve deployed from the capsule. [Figure 36] FIG. 36 illustrates a side view of the gripping features on the anchor. [Figure 37A] FIG. 37A illustrates a side view of a gripping feature on an anchor. [Figure 37B] FIG. 37B illustrates a perspective view of a gripping feature for an anchor. [Figure 37C] FIG. 37C illustrates a perspective view of a gripping feature for an anchor. [Figure 38] FIG. 38 illustrates a side view of a gripping feature for an anchor. [Figure 39A] FIG. 39A illustrates a perspective view of a gripping feature for an anchor. [Figure 39B] FIG. 39B illustrates a perspective view of a gripping feature for an anchor. [Figure 40A] FIG. 40A illustrates a side view of a gripping feature for an anchor. [Figure 40B] FIG. 40B illustrates a side view of a gripping feature for an anchor. [Figure 41] FIG. 41 illustrates a side cross-sectional view of a frame for a prosthetic valve. [Figure 42] FIG. 42 illustrates a cross-sectional side view of the prosthetic valve deployed relative to the implantation site. [Figure 43] FIG. 43 illustrates a perspective view of an anchor with multiple gripping features. [Figure 44]FIG. 44 illustrates a perspective view of the prosthetic valve. [Figure 45] FIG. 45 illustrates a plan view of the prosthetic valve shown in FIG. [Figure 46] FIG. 46 illustrates a top perspective view of a pacemaker lead extending through a channel of the prosthetic valve shown in FIG. [Figure 47] FIG. 47 illustrates a schematic side cross-sectional view of the prosthetic valve shown in FIG. 44 deployed relative to the implantation site. [Figure 48] FIG. 48 illustrates a schematic cross-sectional side view of a prosthetic valve deployed relative to an implantation site with pacemaker leads passing along the side of the prosthetic valve. [Figure 49] FIG. 49 illustrates a perspective view of the prosthetic valve. [Figure 50] FIG. 50 illustrates a distal or outflow end view of the prosthetic valve of FIG. [Figure 51] FIG. 51 illustrates a perspective view of the inner frame of the prosthetic valve of FIG. [Figure 52] FIG. 52 illustrates a side view of the outer frame of the prosthetic valve of FIG. [Figure 53] FIG. 53 illustrates a perspective view of the inner frame of the prosthetic valve of FIG. [Figure 54] FIG. 54 illustrates a side schematic cross-sectional view of the prosthetic valve of FIG. [Figure 55] FIG. 55 illustrates a side schematic cross-sectional view of a portion of the prosthetic valve of FIG. [Figure 56] FIG. 56 illustrates a perspective view of a frame for a prosthetic valve. [Figure 57] FIG. 57 illustrates a proximal or inflow end view of the prosthetic valve of FIG. [Figure 58] FIG. 58 illustrates a perspective view of the prosthetic valve. [Figure 59] FIG. 59 illustrates a side cross-sectional view of the prosthetic valve of FIG. [Figure 60] Figure 60 illustrates a side view of a portion of the inner frame. [Figure 61]FIG. 61 illustrates a perspective view of a portion of the inner frame. [Figure 62] FIG. 62 shows a perspective view of the inner frame including parts of FIGS. 60 and 61. FIG. [Figure 63] FIG. 63 illustrates a cross-sectional view of an artificial valve utilizing the frame shown in FIG. [Figure 64A] FIG. 64A illustrates a proximal or inflow end view of the frame of the prosthetic valve. [Figure 64B] FIG. 64B illustrates a perspective view of the frame shown in FIG. 64A. [Figure 65] FIG. 65 illustrates a side perspective view of a prosthetic valve utilizing the frame of FIG. 64A. [Figure 66] FIG. 66 illustrates a schematic side cross-sectional view of a prosthetic valve utilizing the frame shown in FIG. 64A. [Figure 67] FIG. 67 illustrates a perspective view of the prosthetic valve. [Figure 68] FIG. 68 illustrates a proximal or inflow end view of the prosthetic valve shown in FIG. [Figure 69] FIG. 69 illustrates a proximal or inflow end view of the frame of the prosthetic valve shown in FIG. [Figure 70] FIG. 70 illustrates a side view of the position of the anchor tip relative to the frame shown in FIG. [Figure 71] FIG. 71 illustrates a schematic side cross-sectional view of an artificial valve utilizing the frame shown in FIG. [Figure 72] FIG. 72 illustrates a side view of the frame of the prosthetic valve. [Figure 73] FIG. 73 illustrates a plan view schematic of an artificial valve utilizing a frame such as that shown in FIG. [Figure 74] FIG. 74 illustrates a proximal or inflow end view of the frame shown in FIG. [Figure 75] FIG. 75 illustrates a schematic cross-sectional side view of a prosthetic valve utilizing a frame such as that shown in FIG. [Figure 76] FIG. 76 illustrates a schematic plan view of the prosthetic valve. [Figure 77] FIG. 77 illustrates a perspective view of an inner frame including a clasp anchor. [Figure 78] FIG. 78 illustrates a plan view schematic of an artificial valve utilizing a frame such as that shown in FIG. [Figure 79] FIG. 79 illustrates a perspective view of an artificial valve utilizing a frame such as that shown in FIG. [Figure 80] FIG. 80 illustrates a plan view of the inner frame shown in FIG. [Figure 81] FIG. 81 illustrates a plan view of the clasp anchor. [Figure 82] FIG. 82 illustrates a side view of the location of the anchor tip relative to the outer frame. [Figure 83] FIG. 83 illustrates a plan view of the clasp anchor. [Figure 84] FIG. 84 illustrates a plan view of the clasp anchor. [Figure 85] FIG. 85 illustrates a plan view of the clasp anchor. [Figure 86] FIG. 86 illustrates a schematic cross-sectional side view of a prosthetic valve utilizing a frame such as that shown in FIG. [Figure 87] FIG. 87 illustrates a side schematic cross-sectional view of a variation of the prosthetic valve shown in FIG. [Figure 88] FIG. 88 illustrates a schematic diagram for delivery of the prosthetic valve shown in FIG. [Figure 89] FIG. 89 illustrates a schematic diagram for delivery of the prosthetic valve shown in FIG. [Figure 90] FIG. 90 illustrates a schematic diagram for delivery of the prosthetic valve shown in FIG. [Figure 91] FIG. 91 illustrates a schematic diagram for delivery of the prosthetic valve shown in FIG. [Figure 92] FIG. 92 illustrates a distal or outflow perspective view of the prosthetic valve. [Figure 93] FIG. 93 illustrates a side perspective view of the prosthetic valve of FIG. [Figure 94] FIG. 94 illustrates a plan view of a sheet with a fold. [Figure 95] FIG. 95 illustrates a schematic diagram for delivery of the prosthetic valve shown in FIG. [Figure 96] FIG. 96 illustrates a schematic diagram for delivery of the prosthetic valve shown in FIG. [Figure 97] FIG. 97 illustrates a schematic diagram for delivery of the prosthetic valve variation shown in FIG. [Figure 98] FIG. 98 illustrates a side view of the delivery system. [Figure 99] Figure 99 illustrates a schematic of the delivery system approaching the implantation site. [Figure 100] FIG. 100 illustrates a schematic diagram of the delivery system approaching the tricuspid valve. [Figure 101] FIG. 101 illustrates a schematic diagram of the implant deployed against the tricuspid valve. [Figure 102] FIG. 102 illustrates a schematic diagram of the implant deployed against the tricuspid valve. [Figure 103] FIG. 103 illustrates a schematic of the tether assembly released from the implant. [Figure 104] FIG. 104 illustrates a side view of the prosthetic valve deployed against the tricuspid valve. DETAILED DESCRIPTION OF THE INVENTION

[0027] The specification and drawings provide aspects and features of the present disclosure in the context of several examples of implants, delivery systems, and methods, such as prosthetic or replacement heart valves, configured for use in a patient's vasculature, such as for replacing the patient's native heart valve. These examples may be described in the context of replacing a particular valve, such as a patient's aortic, tricuspid, or mitral valve. However, it will be understood that the features and concepts described herein may also be applied to products other than heart valve implants. For example, the features described herein may be applied to other medical implants, e.g., other types of prosthetic devices, for use elsewhere in the body, such as in an artery, a vein, or other body cavity or location. In addition, particular features relating to valves, delivery systems, etc., should not be construed as limiting, and features in any example described herein can be combined with features in other examples, as desired and appropriate. While the particular examples described herein are described in the context of a transfemoral delivery approach, it will be understood that these examples may be used in connection with other delivery approaches, such as a transapical or transjugular approach. Moreover, it will be understood that certain features described in connection with some examples may be incorporated into other examples, including features described in connection with different delivery approaches.

[0028] 1 illustrates a perspective view of an implant in the form of a prosthetic valve 10. The prosthetic valve 10 may include a prosthetic heart valve for deployment relative to a patient's native heart valve. The prosthetic heart valve may replace the function of the native heart valve. In some instances, other forms of implants and prosthetic valves may be utilized as desired.

[0029] The prosthetic valve 10 may be configured to be deployed relative to the annulus of a native valve, which may include a native mitral valve or a native tricuspid valve. In some examples, other implantation locations may be utilized, such as within the aortic or pulmonary valve, or other valves or locations within the patient's body as desired.

[0030] The prosthetic valve 10 may include a proximal or inlet or upstream end 12, a distal or outlet or downstream end 14 (shown in FIG. 2 ), and a length therebetween. The prosthetic valve 10 may further include a valve portion, preferably formed by a plurality of prosthetic leaflets 16. The valve portion is positioned within a flow channel or passageway for controlling flow through the prosthetic valve 10. The flow channel or passageway is formed by a support structure or valve body 15 of the valve 10. The valve body 15 or support structure has a proximal or inlet or upstream end portion and a distal or outlet or downstream end portion. The prosthetic leaflets 16 mimic and replace the behavior of a native valve leaflet by transitioning between an open state and a closed state. The leaflets 16 allow flow in a first direction and prevent flow in a second direction. The valve segments are positioned within passageways in the valve body 15, thereby replacing the function of the native heart valve by allowing blood to flow in one direction through the passageways. The prosthetic valve leaflets 16 are fabricated from pericardium, such as bovine or porcine pericardium, or from another material as desired. In alternative configurations, the leaflets are formed from a synthetic (e.g., polymeric) material, or the valve segments are mechanical one-way valves.

[0031] The prosthetic 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 leaflets 16.

[0032] Valve body 15 may include, in some examples, one or more bodies. Valve body 15 may include, for example, inner body 18 (shown in FIG. 2) and outer body 20.

[0033] 2 illustrates a cross-sectional schematic view of the prosthetic valve 10. 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 bulbous shape including a curved body that curves radially outward between the proximal end 22 and the distal end 24, or may have another configuration as desired in some examples. The inner body 18 may have a circular shape in some examples. The inner body 18 may support a plurality of prosthetic valve leaflets 16.

[0034] The inner body 18 may include an inner frame 26 (or inner support stent) that may include a plurality of struts 28 (shown in FIG. 4) spaced apart by spaces 30 (shown in FIG. 4). The plurality of struts 28 form expandable and contractible cells. This configuration may allow the inner frame 26 to transition between a non-deployed or unexpanded or straight configuration and a deployed or expanded configuration. For example, the inner frame 26 may transition to the deployed or expanded configuration by expanding radially outward, where the diameter of the inner frame 26 increases and thus the length of the inner frame 26 decreases. Other configurations for the inner frame 26 may be utilized as desired.

[0035] Inner frame 26 may include an outer surface 32, or outward-facing surface, and may include an inner surface 34, or inward-facing surface (shown in FIG. 2). Outer surface 32 may face away from flow channel 13, and inner surface 34 may be oriented toward flow channel 13. Inner frame 26 supports prosthetic valve leaflets 16. Prosthetic valve leaflets 16 are positioned within frame 26.

[0036] Inner body 18 may, for example, include a skirt 36 (shown in FIG. 2 ). In some examples, skirt 36 may be positioned on outer surface 32 of inner frame 26 or may be positioned on inner surface 34 of inner frame 26 (as shown in FIG. 2 ). Skirt 36 may extend along inner frame 26 from proximal end 22 of inner body 18 to distal end 24 of inner body 18, or may extend along only a portion of inner frame 26. Skirt 36 may be configured to impede fluid flow therethrough, to impede lateral fluid flow through flow channel 13, or to promote axial fluid flow through flow channel 13.

[0037] In some examples, the skirt 36 may be configured to have one or more prosthetic leaflets 16 attached thereto. For example, sutures 38 or stitch lines between the prosthetic leaflets 16 and the skirt 36 may attach the prosthetic leaflets 16 to the skirt 36. The sutures 38 or stitch lines may have a curved or pointed shape, thereby taking into account the shape of the prosthetic leaflets 16. An outer end portion 40 (shown in FIG. 2 ) of the prosthetic leaflets 16 may be attached to the skirt 36, and an opposing inner end portion 42 may be configured to coapt when the prosthetic leaflets 16 are opened or closed.

[0038] The prosthetic valve leaflets 16 may be coupled to the skirt 36 and may extend radially inward from the skirt 36. The prosthetic valve leaflets 16 may surround the flow channel 13 as shown in FIG. 2 and may transition between an open state and a closed state to control flow through the flow channel 13. The proximal end of the prosthetic valve 10 may include the inflow end of the prosthetic valve 10 and the distal end of the prosthetic valve 10 may include the outflow end, although other configurations may be utilized as desired. The prosthetic valve leaflets 16 may be positioned about a central axis 43 of the prosthetic valve 10. The inner body 18 and the outer body 20 may each surround the central axis 43 of the prosthetic valve 10.

[0039] The prosthetic valve 10 may include one or more anchors 44, which may be configured to anchor the prosthetic valve leaflets 16 to a portion of the patient's heart, which may include a native valve. The anchors 44 may be particularly configured to anchor to the native valve leaflets of the patient's heart. The anchors 44 may extend around the native valve leaflets to anchor them. The anchors 44 may include distal anchors positioned at the distal end 14 of the valve 10, or may be provided at another location, as desired in some instances. The anchors 44 may include ventricular anchors extending from a downstream portion of the frame of the prosthetic heart valve and shaped to capture the native heart valve leaflets between the anchors 44 and the outer surface 64 of the outer frame 48.

[0040] Each anchor 44 may be configured with a protruding arm configured to extend distally and then curve proximally to the tip of the corresponding anchor 44. This configuration allows the anchors 44 to extend around and even around the distal tip of the native valve leaflet, to hook onto the distal tip of the native valve leaflet, and to be positioned radially outward of the outward-facing surface of the native valve leaflet. The anchors 44 may be configured with a hook-like configuration, as shown in FIGS. 1 and 2, for example. Thus, the anchors 44 may resist forces applied to the valve 10 in an atrial or proximal direction and may anchor the valve 10 within the native valve annulus. Other configurations for the anchors 44 may be utilized in some examples, as desired.

[0041] The anchor 44 is shown in FIGS. 1 and 2 in a deployed or expanded configuration with a tip of the anchor 44 extending proximally. In some examples, the anchor 44 may be configured to have a non-deployed or unexpanded or straight configuration with a tip of the anchor 44 extending distally. Such a configuration is shown, for example, in FIG. 34 . In some examples, the anchor 44 may be configured to be flexible. Upon deployment, the anchor 44 may be configured to transition radially outward from the non-deployed configuration to the deployed configuration, with the tip everting proximally. This action may allow the anchor 44 to evertip onto and anchor to the native valve leaflets upon deployment. Such a configuration is shown, for example, in FIGS. 5A and 5B . In some examples, other deployment methods for the anchor 44 may be utilized as desired.

[0042] Each of the anchors 44 may extend radially outward from the flow channel 13 and from the prosthetic leaflets 16 of the valve 10. The anchors 44 may be configured to extend radially outward from the inner body 18 and may be configured to extend across the gap 46 between the inner frame 26 and the outer frame 48. The anchors 44 may extend to the tip of each corresponding anchor 44. The anchors 44 may be coupled to the distal end 24 of the inner body 18, particularly to the distal end of the inner frame 26. Each of the anchors 44 may 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 comprises the tip of each corresponding anchor 44. The anchors 44 may extend perpendicularly from the proximal portion 50 to the tip of the distal portion 52 when the valve 10 is deployed.

[0043] The valve body 15 may include a seal body 11. The seal body 11 may be positioned radially outward from the prosthetic valve leaflets 16 and may be configured to seal against a portion of the native valve. The seal body 11 may include an outer surface of the prosthetic valve 10. The seal body 11 may define an outer diameter of the prosthetic valve 10 and may include an outer periphery of the prosthetic valve 10. The seal body 11 may include a proximal portion having a proximal end 54 and a distal portion having a distal end 56 (shown in FIG. 2).

[0044] In some examples, seal body 11 may include an outer body 20 positioned radially outward of inner body 18 .

[0045] 2, seal body 11 may include frame 48 and seal skirt 58, or in some examples, may include only a frame or only a seal skirt, as desired. Frame 48 may include an outer frame (or outer support stent) positioned radially outward from inner frame 26.

[0046] The outer frame 48 comprises at least a portion of the seal body 11 configured to apply a seal against a portion of the heart. The outer frame 48 may have a proximal portion 60 coupled to the proximal end 22 of the inner body 18. The proximal portion 60 may extend radially outward from the proximal end 22 of the inner body 18 and from the prosthetic leaflets 16. A distal portion 62 of the outer frame 48 may be spaced apart from the prosthetic leaflets 16 and the inner frame 26 by a gap 46. The gap 46 may be positioned between the outer frame 48 of the seal body 11 and the distal portion of the inner body 18.

[0047] The outer frame 48 may include an outer surface 64 or outward-facing surface and an inner surface 66 or inward-facing surface. The outer surface may face away from the flow channel 13, and the inward surface may face toward the flow channel 13. The outer surface 64 is intended to press against the tissue of the native heart valve to seal with the tissue.

[0048] In some examples, the outer frame 48 may have a length that extends distally a shorter distance than the distal end of the inner frame 26. Thus, the outer frame 48 may be shorter than the inner frame 26. The outer frame 48 may also have a curved configuration that curves outward from the inner frame 26, in which case the maximum diameter of the outer frame 48 is located at a distal portion of the outer frame 48.

[0049] The outer frame 48 of the seal body 11 may include a plurality of struts 68 (shown in FIG. 1 ) forming the frame 48, with spaces 70 between the struts. The plurality of struts 68 form expandable and contractible cells. This configuration, when utilized with the frame 48, may allow the frame 48 to transition between a non-deployed or unexpanded or straight configuration and a deployed or expanded configuration, as shown in FIG. 1 , in which the outer frame 48 and seal body 11 have a curved, bulbous shape. As with the inner frame 26, the length of the outer frame 48 of the seal body 11 may decrease as the diameter of the outer frame 48 of the seal body 11 increases upon deployment. The diameter of the outer frame 48 of the seal body 11 may expand radially outward simultaneously with the inner frame 26 or, in some cases, at a different time or rate of expansion than the inner frame 26. In some examples, the outer frame 48 may be more flexible than the inner frame 26 and may be adapted to conform to the shape of the native heart valve. Both the outer frame 48 and the inner frame 26 may be self-expanding and made from a shape-memory material. The shape-memory material may include Nitinol, or in some examples, may include another material. The self-expanding frame is sized to be deployed within the native heart valve. In some examples, other forms of expandable frames (e.g., balloon-expandable or mechanically expandable) may be utilized.

[0050] The seal body 11 may include a seal skirt 58, which may be coupled to the outer frame 48 of the seal body 11 or, in some examples, may be free from the outer frame 48. The seal skirt 58 may extend along the outer frame 48. The seal skirt 58 may include a fabric skirt that covers at least a portion of the outer surface 64 of the outer frame 48.

[0051] The seal skirt 58 may, in some examples, have a distal portion 72 and a proximal portion 74. The distal portion 72 may extend onto a distal portion of the outer frame 48, for example, onto the outer surface 64 of the outer frame 48. The distal portion 72 may extend proximally to an end 76, which may be positioned, for example, at the midpoint of the outer frame 48, or may be positioned at another location as desired. The distal portion 72 may extend distally to be coupled to the inner body 18, for example, by spanning the gap 46. In some examples, the distal portion 72 may be coupled to one or more anchors 44.

[0052] The proximal portion 74 of the seal skirt 58 may be positioned on the inner surface 66, i.e., on the inward-facing surface, of the outer frame 48. The proximal portion 74 of the seal skirt 58 may, in some examples, extend proximally to the proximal end 54 of the seal body 11.

[0053] The sealing skirt 58 may be made from a material that resists fluid flow therethrough, such as a cloth material, a woven material, or other material such as a polymer. The material may include cloth. Various materials may be utilized for the skirt 58, as desired.

[0054] The seal body 11 may be configured to abut against a portion of the patient's heart to reduce fluid flow. The skirt 58 may be configured to seal against a portion of the native valve annulus. For example, the seal body 11 may abut against the surface of the patient's native valve leaflets to reduce fluid flow between the seal body 11 and the native valve leaflets. The seal body 11 may be configured to abut against other portions of the patient's heart to reduce fluid flow, as desired.

[0055] The seal body 11 may be flexible to allow movement and conformance to the native valve annulus.

[0056] In some examples, at least a portion of the prosthetic valve 10 may include a material that may 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 fabric configured to reduce tissue formation or thrombus formation on the fabric. The fabric may be configured to be thrombophilic to reduce the likelihood of thrombus formation. The fabric may be otherwise configured 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 configured to be thrombophilic or may be otherwise configured to reduce tissue formation or thrombus formation. The coating may be provided on a frame, a skirt, or another portion of the prosthetic valve 10, as desired. In some examples, the material may include a material that forms a portion of the prosthetic valve. For example, the frame may be constructed from a material that resists tissue formation or thrombus formation. One or more prosthetic valve leaflets may be constructed from a material that resists tissue formation or thrombus formation. Any portion of the prosthetic valve may be configured to resist tissue or thrombus formation. Tissue formation may, in some instances, include pannus formation. Other forms of tissue ingrowth may be reduced.

[0057] All or a portion of the skirt may include a material configured to reduce tissue or thrombus formation. The skirt may be constructed from a material (e.g., a fabric) that resists tissue or thrombus formation, or may otherwise be coated with a material that resists tissue or thrombus formation. The skirt may be positioned in a variety of locations. For example, all or a portion of the outer or sealing skirt 58 may include a material configured to reduce tissue or thrombus formation. In some examples, all or a portion of the skirt 36 of the inner body 18 may include a material configured to reduce tissue or thrombus formation.

[0058] The inner surface 80 of the valve body 15 facing the flow channel 13 may include a portion that may be configured to reduce tissue or thrombus formation in the prosthetic valve 10. The inner surface 80 may face away from 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 seal skirt 58, and may face outward from the flow channel 13. The inner surface 80 may surround the flow channel 13.

[0059] In some examples, the end portions of the prosthetic valve 10 may include portions of the prosthetic valve 10 that may be configured to reduce tissue or thrombus formation. For example, the proximal end portion 82 of the prosthetic valve 10 may include portions of the prosthetic valve 10 that may be configured to reduce tissue or thrombus formation, although the distal end portion 84 of the prosthetic valve 10 may alternatively or in combination be utilized. The proximal end portion 82 may include the inflow portion of the prosthetic valve 10 and the distal end portion 84 may include the outflow portion of the prosthetic valve 10, although other configurations may be utilized as desired.

[0060] The portions of the prosthetic valve 10 that may be configured to reduce tissue or thrombus formation may include one or more of a proximal end portion 86 of the inner surface 80 of the valve body 15 and a proximal end portion 88 of the outer surface 81 of the valve body 15. The end portions 86, 88 may be adjacent to one another, as shown in FIG. 2, for example. The end portions 86, 88 may, in some examples, be attached to one another. For example, with reference to FIG. 1, the proximal end of the sealing skirt 58 may be sutured or otherwise attached to the proximal end of the skirt 36. The skirts 58, 36 may be attached to one another at a proximal rim 90 of the prosthetic valve 10.

[0061] In some examples, the portion of the prosthetic valve 10 configured to reduce tissue or thrombus formation may include a barrier to tissue ingrowth at one or more locations. The one or more locations may be various locations on the prosthetic valve 10, as desired. For example, with reference to FIG. 2 , all or a portion of the outer skirt 58, i.e., the sealing skirt, may include a barrier to tissue or thrombus formation. In some examples, all or a portion of the skirt 36 of the inner body 18 may include a barrier to tissue or thrombus formation. Other portions of the prosthetic valve 10 may include a barrier to tissue or thrombus formation, as desired.

[0062] In some examples, the barrier may be configured to reduce or prevent tissue or thrombus formation along an 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.

[0063] All or a portion of the skirt 36 may include a barrier layer that may reduce tissue or thrombus formation. The barrier layer may be configured to be positioned adjacent the prosthetic leaflets 16.

[0064] The barrier layer may include a band of material 92. FIG. 3 illustrates, for example, a band of material 92 that includes the barrier layer. The band 92 may have a variety of shapes and may have an arcuate shape as shown in FIG. 3 or another shape as desired. The band 92 may be configured to be coupled to the prosthetic leaflet 16. The prosthetic leaflet 16 may be coupled to the barrier layer or band 92 by, for example, a suture line 38 or stitch line. The band 92 may extend proximally from the suture line 38 or stitch line to a proximal end portion 94 of the band 92. The band 92 may form a portion of the skirt 36 that may be positioned along the inner frame 26 and line the inner surface 34 of the inner frame 26.

[0065] 4, for example, illustrates the location of bands 92 relative to inner frame 26. Bands 92 may be positioned at and extend distally from proximal end portion 86 of inner surface 80 of valve body 15. Prosthetic leaflets 16 may be bonded to barrier layer or band 92 and may extend distally from sutures 38 or stitch lines to barrier layer or band 92.

[0066] In some examples, the barrier layer or band 92 may be bonded to a portion of the seal skirt 58 of the seal body 11. A proximal end portion 94 of the band 92 may be bonded to the proximal portion 74 of the seal skirt 58, for example. FIG. 1 illustrates that the proximal end portion 94 of the band 92 may be joined to the proximal portion 74 of the seal skirt 58. A suture or stitch line may be provided to bond the proximal end portion 94 of the band 92 to the proximal portion 74 of the seal skirt 58, or in some examples, other forms of bonding may be utilized.

[0067] In some examples, a distal end portion 96 (shown in FIG. 3 ) of the barrier layer or band 92 may be bonded to a proximal end portion (shown in FIG. 2 ) of a remainder 98 of the skirt 36. The remainder 98 of the skirt 36 may extend along and surround a portion of the flow channel 13 distal to the connection to the prosthetic leaflet 16. The band 92 and the remainder 98 of the skirt 36 may alternatively or in combination form a sleeve that surrounds the flow channel 13. In some examples, the remainder 98 of the skirt 36 may be omitted, for example, as shown in FIG. 6 .

[0068] The barrier layer or band 92 may be configured to reduce the spread of tissue or thrombus formation to one or more of the prosthetic valve leaflets 16. For example, with reference to FIG. 5A , the prosthetic valve 10 is shown in an implanted configuration in which the anchors 44 are anchored to the native leaflets 99 of the native valve 100. The outer surface 81 of the valve body 15 may contact the native leaflets 99 or another portion of the native valve 100.

[0069] Over time, after implantation, tissue or thrombus formation may occur along portions of the prosthetic valve 10. For example, referring to FIG. 5B , tissue or thrombus formation 102, which may be in the form of pannus growth, occurs along the surface of the prosthetic valve 10. For example, the outer surface 81 of the valve body 15 experiences tissue or thrombus formation 102. The tissue or thrombus formation 102 may, in some cases, serve to implant and further secure the prosthetic valve 10 to the implantation site. However, the barrier layer or band 92 may function to reduce tissue or thrombus formation. The barrier layer or band 92 may impede tissue or thrombus formation along the inner surface 80 of the valve body 15 and against the prosthetic valve leaflets 16. The barrier layer or band 92 may impede tissue or thrombus formation distally from the proximal rim 90 of the prosthetic valve 10, for example. In this manner, the likelihood of tissue or thrombus formation against the prosthetic valve leaflets 16 may be reduced.

[0070] Such a result may beneficially reduce the likelihood of tissue or thrombus formation along the prosthetic leaflets 16, which could impede the operation of the prosthetic leaflets 16. Furthermore, by reducing the likelihood of tissue or thrombus formation along the flow channel 13, flow along the flow channel 13 may be improved, which may reduce the likelihood of valve stenosis or insufficiency.

[0071] In some examples, the distal end portion 104 of the skirt 36 may be configured to reduce tissue or thrombus formation. The distal end portion 104 may reduce the likelihood of tissue or thrombus formation, for example, in a proximal orientation toward the prosthetic leaflet 16. In some examples, with reference to FIG. 6 , the remainder 98 of the skirt 36, which may include the distal end portion 104 of the skirt 36, may be omitted, and the band 92 (as shown in FIG. 3 ) may comprise the entire barrier layer for the prosthetic leaflet 16.

[0072] In some examples, other portions of the prosthetic valve 10 may include materials that can be configured to reduce tissue ingrowth along portions of the prosthetic valve 10, if desired. In some examples, portions of the prosthetic valve 10 may be configured to accommodate tissue ingrowth. For example, the outer surface 81 of the valve body 15 may be configured to accommodate tissue ingrowth for sealing or anchoring purposes to the implantation site. However, other portions of the prosthetic valve 10, such as the barrier layer or bands 92, or other portions of the prosthetic valve 10, may reduce tissue ingrowth, if desired.

[0073] 7A illustrates a perspective view of one example in which a skirt 83 may be provided, which may include similar features as skirt 36 unless otherwise noted. Skirt 83 may extend from a proximal end portion 85 to a distal end portion 87. Skirt 83 may include a sleeve configured to be positioned within inner frame 26. Skirt 83 may extend along inner surface 34, or the inward-facing surface, of inner frame 26. Skirt 83 may include multiple sections of material sewn or stitched together along stitch lines 89.

[0074] The one or more prosthetic leaflets 16 may extend radially inward from an inner surface 91 of the skirt 83. The inner surface 91 may face the flow channel and may face away from an outer surface 93 of the skirt 83. The one or more prosthetic leaflets 16 may be joined to the skirt 83 by sutures or stitch lines 95.

[0075] FIG. 7B illustrates a cross-sectional view of skirt 83.

[0076] 7C, the proximal end portion 85 of the skirt 83 may be configured to be coupled to the proximal portion 74 of the sealing skirt 58. The proximal end portion 85 of the skirt 83 may be coupled to the proximal portion 74 of the sealing skirt 58, for example, along a stitch line 97. The connection of the inner skirt 83 to the sealing skirt 58 may include the proximal rim 105 of the prosthetic valve.

[0077] 7D , the distal end portion 87 of the skirt 83 may be configured to be coupled to the distal portion 72 of the sealing skirt 58. The distal end portion 87 of the skirt 83 may be coupled to the distal portion 72 of the sealing skirt 58, for example, along a stitch line 101. The connection of the inner skirt 83 to the sealing skirt 58 may include the distal rim 107 of the prosthetic valve.

[0078] FIG. 7E illustrates the position of the skirt 83 relative to the inner frame 26 prior to bonding to the seal skirt 58.

[0079] The skirt 83 may be configured to reduce tissue or thrombus formation along the length of the skirt 83. The outer or inner surface of the skirt 83 may be configured to reduce tissue or thrombus formation along the length of the skirt 83. The skirt 83 may include a barrier layer to reduce tissue or thrombus formation toward the prosthetic valve leaflets 16 and along the flow channel of the prosthetic valve. The distal end portion 87 of the skirt 83 and the proximal end portion 85 of the skirt 83 may each be configured to reduce tissue or thrombus formation in a corresponding proximal or distal direction toward the valve leaflets 16. The distal end portion 87 of the skirt 83 and the proximal end portion 85 of the skirt 83 may each be configured to reduce tissue or thrombus formation from the corresponding distal rim 107 or proximal rim 105, respectively.

[0080] In some examples, the surfaces of the skirt 83 may include a coating or layer that may reduce tissue or thrombus formation. For example, with reference to FIG. 7F , the inner surface 91 of the skirt 83 may include a coating or layer that may reduce tissue or thrombus formation. The inner surface 91 may include a polymeric or laminate material that may reduce tissue or thrombus formation. The outer surface 93 of the skirt 83 may include a woven fabric or other form of material. In some examples, both surfaces 91, 93 of the skirt 83 may reduce tissue or thrombus formation.

[0081] 7G illustrates a prosthetic valve 103 utilizing a skirt 83. A distal end portion 87 of the skirt 83 may be configured to be coupled to the distal portion 72 of the sealing skirt 58. The prosthetic valve 103 may include each feature of the prosthetic valve 10 unless otherwise noted.

[0082] Each feature in Figures 1-7G may be used alone or in combination with any other example disclosed herein.

[0083] In some examples, other configurations of prosthetic valves may be utilized. FIG. 8, for example, illustrates the configuration of frame 110 of prosthetic valve 112 (shown in FIG. 11). Frame 110 and prosthetic valve 112 may include the features of frame and prosthetic valve 10 described with respect to FIGS. 1-7G unless otherwise noted. Frame 110 may include, for example, outer frame 114 and inner frame 116. Outer frame 114 may include a plurality of struts 118 separated by spaces and forming a lattice, similar to outer frame 48 of FIG. 1. Inner frame 116 may similarly include a plurality of struts 120 separated by spaces and forming a lattice, similar to inner frame 26 of FIG. 4.

[0084] 9 illustrates the outer frame 114 separated from the inner frame 116. The outer frame 114 may be configured to form a shoulder 121 or protrusion on the outer surface 122 of the outer frame 114 relative to a distal end portion 124 of the outer frame 114. The shoulder 121 may function to reduce distal, or toward the ventricle, migration of the prosthetic valve 112 upon implantation.

[0085] 10 illustrates the inner frame 116 separated from the outer frame 114. A plurality of arms 126, including anchors, may extend radially outward from a distal end portion 128 of the inner frame 116.

[0086] 11 illustrates a perspective view of the prosthetic valve 112 with one or more skirts applied to the frames 114, 116. The prosthetic valve leaflets 129 are positioned within the flow channels of the prosthetic valve 112.

[0087] Each feature of the prosthetic valve 112 may be utilized with any of the examples disclosed herein.

[0088] In some examples, at least a portion of the prosthetic valve may include a frame having a roughened surface. With reference to FIG. 12 , for example, a portion of frame 130 may include a roughened surface 132. The portion of frame 130 may include struts 134a-d, which may be configured and utilized in a manner similar to other frames disclosed herein. Roughened surface 132 may include all or a portion of frame 130.

[0089] The roughened surface 132 may be positioned on an outer surface 136 of the frame 130, in some examples. The outer surface 136 may be configured to contact a portion of the native valve, such as the native valve leaflets or annulus, or other portion. The roughened surface 132 may be configured to provide friction against the portion of the native valve. Such friction may be used to improve anchoring to that portion of the native valve. In some examples, the frame 130 may include an outer frame or portion of a seal body of the prosthetic valve to form a seal against the native valve. The outer frame or portion of the seal body may be configured to contact a portion of the native valve. For example, with reference to FIG. 1 , a proximal portion of the outer frame 48 may be exposed and contact a portion of the native valve. With reference to FIG. 11 , a proximal portion of the outer frame 114 may also be exposed and contact a portion of the native valve. In some examples, the roughened surface 132 may be positioned at a distal portion of the outer frame and configured to contact a portion of the native valve.

[0090] In some examples, other portions of the frame may include roughened surfaces. For example, one or more anchors (e.g., the distal anchor) may include roughened surfaces. Such surfaces may improve anchoring by increasing friction against one or more native valve leaflets. All or a portion of the inner frame may include roughened surfaces. Such surfaces may be utilized for bonding to the prosthetic valve leaflets or to provide another function.

[0091] The roughened surface may have a variety of forms. In some examples, the roughened surface may include a pattern of protrusions extending from the surface of frame 130. In some examples, the roughened surface may include one or more voids within the surface of frame 130 (e.g., as depicted in FIGS. 17 and 18).

[0092] In some examples, portions 138 of frame 130 adjacent roughened surface 132 may be smooth. One or more roughened surfaces 132 may be selectively positioned on portions of frame 130 to provide a desired configuration of roughened surface 132. One or more smooth portions 138 may be positioned adjacently as desired.

[0093] In some examples, smooth portion 138 may comprise a polished surface of frame 130. Rough surface 132 may comprise an unpolished surface that forms the surface roughness. Polishing may occur during the formation process of frame 130. Areas of frame 130 may be selectively polished to form frame portions with surface roughness and smooth portions.

[0094] In some examples, the roughened surface 132 may include residue from the frame formation process. For example, when a frame is formed, surface residue may be created that would normally be removed before the frame is used. However, the surface residue may remain and may remain on the surface of the frame by remaining unpolished in one or more areas. In some examples, the frame may be made from a shape memory material (such as nitinol or another shape memory material), and the surface residue may be present on the shape memory material. The roughened surface may include the unpolished surface roughness of nitinol.

[0095] The pattern of the roughened surface 132 may be irregular in some examples. For example, FIG. 13 illustrates a close-up view of the roughened surface 132 having an irregular pattern. The irregular pattern may be due to the irregular nature of the roughened surface 132 including residue from the forming process. FIG. 14 illustrates a side view of the roughened surface 132 shown in FIG. 13. The roughened surface 132 may include a plurality of peaks that may have irregular spacing and irregular heights from the base surface 140 of the frame 130.

[0096] In some examples, the roughened surface may be formed in a variety of other manners, such as by sputtering or depositing particulate matter onto the frame, or by physically abrading the frame to form the roughened surface.

[0097] In some examples, microstructures may be formed on the frame. For example, FIG. 15 illustrates microstructures 142 forming a regular pattern on the frame. The microstructures may be configured to provide adhesion to the implantation site by generating van der Waals force interactions. FIG. 16 illustrates a side view of the microstructures 142. Other forms of friction may be provided due to the regular pattern. The microstructures 142 may have various shapes, including circles, squares, dots, triangles, or others.

[0098] In some examples, the roughened surface may include one or more voids 144 within the surface of the frame. Figure 17, for example, illustrates a plurality of voids 144, and Figure 18 provides a cross-sectional side view of the voids 144. The voids 144 may be irregular or regular in configuration. The voids 144 may be formed in a variety of ways, including by chemical attack or physical impact against the frame surface.

[0099] In some examples, the roughened surface may be utilized for friction against a portion of the native valve. The roughened surface may improve anchoring or fixation of the prosthetic valve to the implantation site. In some examples, the roughened surface may be utilized to promote tissue ingrowth. For example, the roughened surface may improve tissue growth for adhesion and sealing, as desired. Tissue formation or thrombus formation may occur. For example, a series of voids 144 or a series of protrusions may improve tissue growth. The roughened surface may be utilized for other purposes in some examples.

[0100] Each feature in Figures 12-18 may be used alone or in combination with any other example disclosed herein.

[0101] In some examples, the valve body may include one or more gripping features configured to be positioned radially inward of one or more native valve leaflets. One or more anchors may be configured to be positioned radially outward of one or more native valve leaflets and configured to press one or more of the native valve leaflets against the one or more gripping features, thereby reducing movement of the one or more native valve leaflets relative to the valve body. The anchors may press the native valve leaflets against the gripping features to secure the prosthetic heart valve within the native heart valve.

[0102] For example, referring to FIG. 19, a seal body frame 150 is shown in a flat pattern. The frame 150 may include features of the outer frame 114 shown in FIG. 9 or the outer frame 48 shown in FIG. 1, unless otherwise noted. The frame 150 may comprise a portion of the seal body or may be otherwise configured to form a seal against the native valve. The frame 150 may comprise the outer frame of a multi-frame prosthetic valve or may be utilized in a single-frame implementation.

[0103] Frame 150, like other frames disclosed herein, may include a plurality of struts 152 and openings 154, 155 between the struts.

[0104] In some examples, one or more gripping features 156 may be provided. The gripping features 156 may have a variety of configurations. For example, with reference to FIG. 19 , the gripping features 156 may include one or more protrusions extending from the frame 150. Each protrusion may extend, for example, in a distal direction. In some examples, other protrusion directions may be utilized.

[0105] The protrusions may be positioned to be circumferentially aligned with anchors of the prosthetic valve, in some examples. For example, referring to FIG. 21 , anchor 158 is shown aligned with gripping feature 156, with tip 168 of anchor 158 positioned at gripping feature 156. In some examples, other positions for the gripping feature may be utilized.

[0106] 19 , in some examples, the gripping feature 156 may extend distally toward an opening 154, into which an anchor 158 may be circumferentially aligned. The opening 154 may be positioned between adjacent struts 160, which may extend distally from the gripping feature 156. The adjacent struts 160 may extend distally to an apex 162 of the strut 160, which may comprise the distal-most portion of the frame 150. The gripping feature 156 may be positioned at a proximal end portion of the strut 160.

[0107] Each of the gripping features 156 may include a pointed tip, and in some examples may include prongs or barbs. The gripping features 156 may have other configurations in some examples.

[0108] The anchor 158 may be configured to press one or more native leaflets against one or more gripping features, thereby reducing movement of one or more native leaflets relative to the valve body. The anchor 158 may be configured to clamp with one or more gripping features. The anchor 158 may be biased to apply an inward force against the leaflet, thereby pressing the leaflet against the gripping feature. The gripping feature or the valve body may be biased to apply an outward force against the leaflet, thereby causing the anchor 158 to press the leaflet against the gripping feature. In some examples, the anchor and valve body may not be biased, but may be sized and positioned relative to one another such that the anchor presses one or more native leaflets against one or more gripping features. For example, FIG. 20 illustrates a valve body 161 and anchor 164 configuration that does not use a gripping feature. The native leaflets 99 may slide proximally relative to the valve body 161 after implantation, if possible. For example, the native valve 100 may expand or otherwise change the configuration of the native valve leaflets 99 or the native valve 100. Although the valve body 161 may slide distally (indicated by arrow 166), this may be undesirable. The use of anchors 158 configured to reduce movement of one or more native valve leaflets relative to the valve body by pressing one or more native valve leaflets against one or more gripping features may beneficially reduce the likelihood of such axial movement of one or more native valve leaflets relative to the valve body. Distal movement of the prosthetic valve, i.e., movement toward the ventricle, may be resisted. Adverse consequences due to dynamic variations in the valve anatomy (e.g., dilation) may be reduced.

[0109] 21A illustrates a plan view of the position of anchor 158 relative to grasping feature 156. Anchor 158 may include a tip 168 that may be aligned with the position of grasping feature 156. Tip 168 of anchor 158 may be located at the same circumferential position as grasping feature 156 and may be located at the same axial position or height as grasping feature 156. Thus, the native valve leaflet may be pressed between grasping feature 156 and tip 168 of anchor 158.

[0110] 21B, for example, illustrates a side cross-sectional view of the configuration shown in FIG. 21A. Tip 168 is positioned to press the native valve leaflets into space 170 between tip 168 and grasping feature 156.

[0111] In some examples, anchor 158 may be configured to press the native valve leaflet against grasping feature 156, thereby biasing the native valve leaflet between grasping feature 156 and anchor 158. For example, anchor 158 and grasping feature 156 may be positioned such that the leaflet may be biased radially inward toward a radially inner region 172 of grasping feature 156 and anchor 158. Such bias may further enhance the grip of the native valve leaflet.

[0112] In some examples, a portion of anchor 158 may include a recess configured to receive gripping feature 156. With reference to FIG. 21B , for example, tip 168 of anchor 158 includes recess 174 configured with a contoured surface of tip 168. The contoured surface may correspond to the shape of gripping feature 156 and may assist in radially inward deflection of the native valve leaflets. In some examples, other configurations for anchor 158 and gripping feature 156 may be provided.

[0113] 22A and 22B illustrate an exemplary deployment of a prosthetic valve including the grasping features 156 and anchors 158. For example, referring to FIG. 22A, the anchors 158 are shown deployed relative to the native valve 100 with the tips 168 of the anchors 158 positioned radially outward of the native valve leaflets 99. The frame 150 may expand radially outward and approach the native valve leaflets 99. Retracting a retaining body, such as a capsule 176, may allow the frame 150 to expand.

[0114] 22B illustrates the frame 150 in an expanded state. The anchors 158 press one or more native leaflets 99 toward one or more of the grasping features 156, thereby reducing movement of the native leaflet(s) 99 relative to the valve body 178. The likelihood of distal movement of the valve body 178 relative to the native leaflets 99, i.e., toward the ventricle, may be reduced. The native leaflets 99 are also shown deflected between the grasping features 156 and the anchors 158.

[0115] In some examples, the configuration of the gripping feature or anchor may be varied as desired. For example, with reference to FIG. 23, gripping feature 180 may include a surface roughness of the frame. The surface roughness may be formed in various manners as desired. Gripping feature 180 may include a protrusion on which the surface roughness may be positioned. The protrusion may be positioned in a similar location to gripping feature 156 shown in FIG. 19, or may be provided in a different location as desired. Gripping feature 180 may be aligned with anchor 184 (shown in FIG. 24A) in a similar manner to gripping feature 156 shown in FIG. 19. For example, FIG. 24A illustrates the alignment of gripping feature 180 with tip 182 of anchor 184.

[0116] 24B illustrates a side cross-sectional view of the position of the gripping feature 180 relative to the anchor 184. The gripping feature 180 contacts and provides friction against the native leaflet 99. The gripping feature 180 clamps together with the anchor 184.

[0117] In some examples, other configurations of gripping features or anchors may be provided. For example, FIG. 25 illustrates one or more gripping features 186 positioned on longitudinally extending struts 160 of a frame 151. The gripping features 186 are located along the outer surface of the frame 151. The struts 160 surround openings 154 with which the anchors are circumferentially aligned. The gripping features 186 include protrusions that extend laterally inward toward the openings 154. The protrusions may include prongs or barbs. Multiple gripping features 186 may extend laterally inward toward a respective one of the openings 154. Other locations may also be used, such as extending from the apex of the strut 160. The gripping features may be asymmetrically positioned in some examples. The gripping features may face distally or in the outflow or inflow direction or in the proximal or inflow direction. In some examples, the gripping features may flare radially outward. In some examples, the gripping features may be positioned only along the downstream, outflow, or distal portion of the frame 151, as depicted in FIG. 25. In some examples, the gripping features may be positioned along the entire outer frame.

[0118] Anchor 190 may be circumferentially aligned with opening 154. For example, FIG. 26 illustrates an example of the position of anchor 190 with respect to opening 154 in frame 151. Tip 192 of anchor 190 is shown circumferentially aligned with opening 154 in frame 151. FIG. 27 illustrates a perspective view of anchor 190 with respect to gripping feature 186.

[0119] The gripping features disclosed herein may protrude from the skirt or other material of the prosthetic valve. For example, as shown in FIG. 27, the gripping features 186 protrude from or extend through the sealing skirt 194 of the prosthetic valve. In some examples, the gripping features may protrude from the skirt or may be covered by the skirt, as desired.

[0120] The location of the gripping feature may be varied in some instances so that the gripping feature is positioned offset from the location of the anchor. For example, FIG. 28 illustrates a variation in which gripping feature 186 is circumferentially offset from anchor 190. The circumferential offset may be increased from the configuration shown in FIG. 27, if desired. Anchor 190 may be configured to clamp with one or more gripping features circumferentially offset from the location of anchor 190.

[0121] 29A and 29B illustrate an example in which the anchor 171 may be positioned at the same radial distance as the grasping feature 173 when clamping with the grasping feature 173. The tip of the anchor 171 may be positioned distal to the grasping feature 173. The anchor 171 may press the native leaflets 99 toward the grasping feature 173, thereby reducing movement of the native leaflets 99 relative to the valve body. The anchor 171 may bias the native leaflets 99 radially inward, as shown in FIG. 29B.

[0122] The gripping features 173 may be positioned on struts of the frame 175, for example, as shown in Figure 29A. The gripping features 173 may be positioned in a manner similar to the gripping features shown in Figures 25-28. In some examples, the gripping features 173 may be positioned in other locations or have other configurations.

[0123] 30A and 30B illustrate an example in which the anchor 177 may be positioned radially inward of the grasping feature 179. The tip of the anchor 177 may be positioned distal to the grasping feature 179. The anchor 177 may press the native leaflets 99 toward the grasping feature 179, thereby reducing movement of the native leaflets 99 relative to the valve body. The anchor 177 may bias the native leaflets 99 radially inward, as shown in FIG. 30B.

[0124] The gripping features 179 may be positioned on struts of the frame and may protrude distally, for example as shown in Figure 30A. The gripping features 179 may be positioned in a manner similar to the gripping features shown in Figures 25-28. In some examples, the gripping features 179 may be positioned in other locations or have other configurations.

[0125] In some examples, the prosthetic valve may be coupled to the native valve using the gripping features. Figure 31 illustrates an example where the prosthetic valve 181 may be anchored to the native valve by, for example, a clamp between the anchor 177 and the gripping feature 179. The native valve leaflets 99 may be secured to the prosthetic valve 181.

[0126] The gripping features may be used to allow the outer diameter of the prosthetic valve 181 to be reduced. The outer diameter of the valve body 183 may be reduced. The outer diameter of the valve body 183 may be smaller than the diameter of the annulus of the native valve, for example. Thus, the outer surface of the valve body 183 may be spaced apart from the diameter of the annulus of the native valve. However, coupling of the prosthetic valve 181 to the leaflets 99 may anchor the prosthetic valve 181 in place relative to the native valve. The leaflets 99 may extend radially inward into the prosthetic valve 181, thereby reducing fluid flow out of the flow channel 185 of the prosthetic valve 181.

[0127] The use of a valve body 183 having an outer surface spaced away from the valve annulus may reduce the likelihood of electrical conduction problems or other undesirable effects that may be caused by the prosthetic valve 181. The location of the anchors 177 may further reduce outward or radial pressure on the native annulus, thereby reducing the likelihood of conduction problems. The native valve may also be allowed to reduce in diameter or reshape over time after implantation of the prosthetic valve 181.

[0128] In some examples, example grasping features disclosed herein may be disengaged if desired. For example, a retraction or recapture procedure applied to the prosthetic valve may unclamp one or more anchors from the grasping feature, allowing the grasping feature to be released. The prosthetic valve may be repositioned to a desired location, and the grasping feature may be reengaged, as desired.

[0129] Other variations in the configuration of the gripping features and anchors may be utilized.

[0130] Each feature in Figures 19-31 may be used alone or in combination with any other example disclosed herein.

[0131] In some instances, one or more gripping features may be utilized that may be configured to engage the surface of the native valve when an anchor fails to capture one or more native valve leaflets. Referring to Figure 32, a distal perspective view of a prosthetic valve 200 including such a gripping feature is shown. The gripping features may be provided in various locations, as desired.

[0132] 32 , one or more anchors 202 of a prosthetic valve 200 may include a gripping feature 204. The gripping feature 204 may be positioned on an arm portion 206 of the corresponding anchor 202, or may be positioned on another portion of the anchor 202, as desired. The gripping feature 204 may be positioned on a portion of the anchor 202 that is configured to face radially outward. Other locations for the gripping feature 204 may be provided, in some examples.

[0133] The gripping feature 204 may include a protrusion or prong that may extend distally. For example, the gripping feature 204 may include a coupling portion 208 for coupling to the anchor 202 and a distally extending protrusion 210. The protrusion 210 may have an angled tip or other configuration, in some examples. The coupling portion 208 may include an arm that may be sutured or otherwise coupled to the anchor 202. The protrusion 210 may be coupled to the coupling portion 208 by a bend or other structure.

[0134] 33 illustrates an exemplary deployment of the prosthetic valve 200. The anchor 202b captures the native leaflet 99b. Thus, the tip 212b of the anchor 202b is positioned radially outward from the native leaflet 99b, and the grasping feature 204b (configured similarly to the grasping feature 204) is positioned radially outward from the native leaflet 99b that it is intended to capture. Therefore, the grasping feature 204b does not engage the leaflet 99b because the grasping feature 204b faces radially outward.

[0135] Referring to the right side of FIG. 33 , the anchor 202a fails to capture the leaflet 99a. Thus, the grasping feature 204a (configured similarly to the grasping feature 204) engages against the face of the native leaflet 99a when the anchor 202a fails to capture the native leaflet 99a. Due to its radially outward orientation, the grasping feature 204a may encroach on the radially inward face of the native leaflet 99a. The anchor 202a is positioned radially inward of the native leaflet 99a. The grasping feature 204a may be more resistant to force in the distal direction than in the proximal direction. Thus, during implantation, blood pressure or other forces located distal to the prosthetic valve 200 may seat the grasping feature 204a in place against and engage the leaflet 99a. Thus, the grasping feature 204a may function to anchor the anchor 202a to the leaflet 99a despite the anchor 202a failing to capture the leaflet 99a.

[0136] In some examples, the gripping features 204 may be configured to face radially inward when the anchors 202 are in the undeployed configuration. FIG. 34 illustrates the anchors 202a, b in an undeployed configuration, for example, within the capsule 176 or other retention member. The anchors 202a, b may be elongated or straight and may extend distally. The gripping features 204a, b may face radially inward, thereby reducing the likelihood of snagging or catching on the interior surface of the capsule 176 or other portions of the delivery system. During deployment, retracting the capsule 176 may allow the anchors 202 to expand radially outward and may be allowed to invert from the position shown in FIG. 34 .

[0137] 35 illustrates that anchor 202 can be expanded radially outward, for example, by retracting capsule 176. Gripping features 204 are shown with reduced likelihood of catching or getting caught against the interior surface of capsule 176 or against the interior surface of other portions of the delivery system. Anchor 202 may bend and reverse orientation upon deployment, causing gripping features 204 to face radially outward, as desired (e.g., as depicted in FIG. 33).

[0138] The configuration of the gripping feature 204 may be varied as desired. Figure 36, for example, illustrates a configuration in which the gripping feature 212 includes a protrusion having a radially outwardly curved distal end portion 214, extending to a distal tip 216 positioned radially outward of the anchor 202.

[0139] Figures 37A-C illustrate a configuration of gripping features 220 in which the strip of material has cuts therein to form a plurality of protrusions 222 when the strip of material is bent. Figure 37B illustrates the strip of material in a flattened configuration. Figure 37C illustrates the strip when bent, with the protrusions 222 extending outward. As shown in Figure 37A, the material may be bent onto the arms of the anchor 202, causing the protrusions 222 to extend radially outward.

[0140] 38 illustrates a configuration of the gripping feature 224 including a strip of laterally extending protrusions 226. The strips may be applied to the arms of the anchor 202 such that the protrusions 226 engage against the surface of the native valve.

[0141] 39A and 39B illustrate the configuration of gripping feature 228 including tube 230. Tube 230 may include a plurality of notches, where edges 232 are configured to grip a portion of the native valve when tube 230 is deflected. FIG. 39B, for example, illustrates deflected tube 230, where edges 232 are exposed. In some examples, the outer surface of the anchor may be made from tube 230, where edges 232 are exposed for engaging against the surface of the native valve. Tube 230 may be deflected to expose edges 232.

[0142] 40A and 40B illustrate configurations of the gripping feature 234 including one or more filaments 236 or wires. The filaments 236 or wires may project radially outward from the anchor 202 and may be configured to be deflectable and smooth as they slide proximally along the native leaflet 99a, and may be configured to be rigid and engage the native leaflet 99a as they slide distally along the native leaflet 99a. FIG. 40B, for example, illustrates the filaments 236 engaging the leaflet 99a when a distal force is applied to the anchor 202. In such a configuration, the gripping feature 234 may slide proximally to be positioned in a desired position relative to the leaflet 99a, and then a distal force may be applied to the anchor 202 to allow the gripping feature 234 to engage the leaflet 99a. The gripping feature 234 may be positioned on the tip of the anchor, or on the curved portion of the anchor, or on the lower loop portion of the anchor, as desired.

[0143] In some examples, other configured gripping features may be utilized. For example, with reference to FIG. 32 , one or more gripping features 240 may be positioned on a valve body 242. The gripping feature 240 may include prongs that may extend from an outer frame 244 of the valve body 242. The gripping feature 240 may be positioned in various locations as desired. For example, the gripping feature 240 may be positioned at a distal apex 246 of a strut 248 of the frame 244. The distal apex 246 may include the outflow apex of the frame 244. Other locations may be utilized as desired.

[0144] In some examples, the gripping features 240 may be configured to protrude radially outward from the valve body 242 a greater radial distance than the anchors 202. FIGURE 41 illustrates, for example, that the outer frame 244 or distal apexes 246 of the valve body 242 may protrude radially outward a greater distance than the anchors 202. The gripping features 240 protrude radially outward a greater distance than the anchors 202. In this manner, if the anchors fail to capture a leaflet, the gripping features 240 protrude radially outward to engage the missed leaflet.

[0145] 33, for example, illustrates the use of a radially outwardly projecting grasping feature 240a (configured similarly to grasping feature 240) to engage a leaflet 99a that has failed to be captured by anchor 202a. Gripping feature 240a may penetrate into the inner surface of leaflet 99a to engage leaflet 99a. Referring to the left side of FIG. 33, grasping feature 240b is positioned to engage leaflet 99b despite anchor 202b capturing leaflet 99b.

[0146] The grasping features 240 may be deployed in the manner shown in FIG. 42. The anchors 202a, b may be deployed. Anchor 202b captures leaflet 99b. Anchor 202a fails to capture leaflet 99a. The grasping features 240a, b may be deployed to expand radially outward. The grasping feature 240a may engage and anchor securely to leaflet 99a. The grasping features 240a, b may be retracted radially inward in a recapture procedure, if desired.

[0147] The deployment sequence shown in FIG. 42 illustrates the use of grasping features 204a, b. However, in some examples, the use of grasping features 204a, b may be omitted, and grasping features 240a, b may comprise the only feature for anchoring in the event of a failure to capture a valve leaflet. In some examples, grasping features 204a, b may comprise the only feature for anchoring in the event of a failure to capture a valve leaflet. Grasping feature 204 may be utilized only in combination with grasping feature 240, and grasping feature 240 may likewise be utilized alone or in combination with grasping feature 204.

[0148] In the undeployed configuration shown in FIG. 34, the gripping features 204a, b may extend distally so that they do not contact the inner surface of the capsule or the inner surface of other parts of the delivery system.

[0149] In some instances, a combination of features may be provided. For example, Figure 43 illustrates the combined use of a gripping feature 204 on the anchor 202 and a gripping feature 240 on the valve body. The gripping feature 186 disclosed with respect to Figures 27-32 may also be utilized.

[0150] Various combinations of each feature across multiple examples may be utilized.

[0151] Each feature in Figures 32-43 may be used alone or in combination with any other example disclosed herein.

[0152] In some examples, the prosthetic valve may include a valve body having an outer surface, and the outer surface of the valve body may include a channel for passing a pacemaker lead. For example, referring to FIGURE 44, a perspective view of prosthetic valve 250 is shown. Prosthetic valve 250 may include features similar to other prosthetic valves disclosed herein, unless otherwise noted.

[0153] The prosthetic valve 250 may include a valve body 252 having an outer surface 254. The outer surface 254 of the valve body 252 may include a surface configured to contact a native valve. The outer surface 254 may, in some instances, include a sealing surface configured to form a seal with the native valve. For example, the outer surface 254 may include the outer surface of a seal body configured to form a seal with the native valve.

[0154] In some examples, the outer surface 254 may include a channel 256 for passing a pacemaker lead. The channel 256 may be configured to pass the pacemaker lead longitudinally from a proximal portion of the prosthetic valve 250 toward a distal portion of the prosthetic valve 250.

[0155] The channel 256 may be positioned between struts 258 of a frame 260 of the valve body 252. The struts 258 may be spaced apart by openings, for example, similar to other examples of frames disclosed herein. In some examples, the channel 256 may extend through one of the openings. The channel 256 may include a recess in a skirt 262 that may be positioned on the frame 260. The skirt 262 may include, for example, a sealing skirt configured to form a seal with the native valve. The location of the channel 256 between the struts 258 of the frame 260 may allow the skirt 262 to recess at the channel 256 due to the absence of the struts 258. The channel 256 may include a recess in the outer surface 254 of the valve body 252 and the skirt 262. The skirt 262 may be configured to deflect inward to form the channel 256. Deflection may occur as the pacemaker lead passes between the outer surface 254 of the valve body 252 and the inner surface of the native valve (eg, the native annulus).

[0156] In some examples, the proximal surface 264 of the skirt 262 may include a tapered surface. The tapered shape of the proximal surface 264 may allow the pacemaker lead to more easily extend into the channel 256 during distal insertion into the prosthetic valve 250. The tapered surface may include guiding features to guide the pacemaker lead into the channel 256.

[0157] FIG. 45 illustrates a top view of prosthetic valve 250, showing, for example, the recessed portion of channel 256.

[0158] The prosthetic valve 250 may be implanted at the implantation site. During implantation, the outer surface 254 of the valve body 252 may contact the native valve. A pacemaker lead 265 may be inserted adjacent to the prosthetic valve 250 during the implantation procedure or a subsequent procedure. FIG. 46 , for example, illustrates an implanted prosthetic valve 250, with the outer surface 254 of the valve body 252 positioned against the native valve. A channel 256 may be positioned to allow the pacemaker lead 265 to pass through and extend distally, i.e., toward the ventricular side, of the prosthetic valve 250. The 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 may form a seal around the pacemaker lead extending through the channel 256.

[0159] 47 illustrates a side cross-sectional schematic view of a prosthetic valve 250 implanted relative to a native valve 100. A pacemaker lead 265 is shown passing through a 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 advantageously does not have to pass through the central flow channel of the prosthetic valve, as positioning in this manner could interfere with the operation of the prosthetic valve leaflets.

[0160] 48 illustrates a side schematic view of a pacemaker lead 265 passing through the channel 256 to the distal, i.e., ventricular, side of the prosthetic valve 250. A distal end portion 268 of the pacemaker lead 265 may be implanted at a desired location within the ventricle. A proximal end portion 269 of the pacemaker lead 265 may be coupled to a pacemaker. The pacemaker lead 265 may be positioned within the channel 256, where it may be circumferentially positioned between two of the anchors 271. The spacing between adjacent anchors 271 may help secure the pacemaker lead 265 adjacent to the prosthetic valve 250. The spacing between adjacent anchors 271 may seal the pacemaker lead 265 extending through the channel 256.

[0161] 19-31 may be utilized with prosthetic valve 250. The gripping features may help secure prosthetic valve 250 in place as a pacemaker lead is advanced distally through channel 256.

[0162] Each feature in Figures 44-48 may be used alone or in combination with any other example disclosed herein.

[0163] 49 illustrates a perspective view of a prosthetic valve 280 that may be utilized in any example herein. Unless otherwise stated, prosthetic valve 280 may include each feature described with respect to prosthetic valve 10, prosthetic valve 112, or prosthetic valve 250. Prosthetic valve 280 may also include each feature of any other prosthetic valve or example disclosed herein.

[0164] The prosthetic valve 280 includes one or more prosthetic leaflets 282 (shown in FIG. 50), which may be configured similarly to the prosthetic leaflets 16 disclosed with respect to FIGS. 1-7G. The prosthetic leaflets 282 may be positioned within a flow channel 284 (shown in FIG. 50) of the prosthetic valve 280. The prosthetic leaflets 282 are supported by a valve body 286 and may extend radially inward from the valve body 286 into the flow channel 284.

[0165] The valve body 286 may include an inner body 288 (shown in FIG. 50 ) and an outer body 290. The inner body 288 may include each feature of the other examples of inner bodies disclosed herein unless otherwise noted. The inner body 288 may include an inner frame 292 (shown in FIGS. 51 , 53 , and 54 ). The inner frame 292 supports the prosthetic valve leaflets 282. Referring to FIG. 51 , the inner frame 292 may include a plurality of struts 294 that may be spaced apart by spaces or openings 296, in a manner similar to the other examples of inner frames disclosed herein. The inner frame 292 may include a proximal end portion 298 and a distal end portion 300. The inner frame 292 may include one or more couplers 299 for coupling to the outer body 290. The coupler or couplers 299 may be positioned at the proximal end 301 of the inner frame 292, or may be positioned at another location, as desired.

[0166] In some examples, inner frame 292 may have a proximal end portion 298 that is wider than a central portion 302 of inner frame 292 and a distal end portion 300 that is wider than central portion 302 of inner frame 292. Inner frame 292 may curve outward from central portion 302 to wider proximal end portion 298 and may also curve outward from central portion 302 to wider distal end portion 300. Inner frame 292 may have a substantially hourglass shape or profile, which may be similar to the shape or profile of inner frame 116 shown in FIG. 10 , for example. Distal end portion 300 of inner frame 292 may be coupled to anchor 304.

[0167] The outer body 290 may include each feature of other examples of the outer body disclosed herein unless otherwise stated. The outer body 290 may include a seal body and may also include an outer frame 306 (shown in FIG. 52 ) and a seal skirt 308, or outer skirt, or fabric skirt, positioned on the outer frame 306. The outer frame 306 may be positioned radially outward from the inner frame 292. An 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 seal skirt 308 extends along the outer surface 307 of the outer frame 306.

[0168] FIG. 52 illustrates the outer frame 306 separated from other features of the prosthetic valve 280. The outer frame 306 may include a plurality of struts 310, which may be spaced apart by spaces or openings 312, in a manner similar to other examples of outer frames disclosed herein. The struts 310 may define openings 312 between them. The struts 310 may form expandable cells. The outer frame 306 may include a proximal end portion 314 and a distal end portion 316. The proximal end portion 314 may include a coupling portion having one or more couplers 318 adapted to couple to the inner frame 292, particularly configured to couple to the coupler 299 of the inner frame 292. The couplers 318 may include eyelets, for example, that may be positioned along the proximal, inflow, or upstream, end portion of the frame 306 to receive sutures. The prosthetic heart valve may be deployed by being attached to sutures (e.g., tether assemblies), whereby releasing tension on the sutures will deploy the valve. After deployment, the prosthetic heart valve may be retrieved by applying tension to the sutures.

[0169] The proximal end portion 314 of the outer frame 306 may be joined to the proximal end portion 298 of the inner frame 292. The outer frame 306 may project radially outward from the joining portion to a first tapered portion 320. The first tapered portion 320 may extend radially outward from the joining portion and may taper at a first angle (this angle is more clearly shown in FIGS. 54 and 55 ). The first tapered portion 320 may extend radially outward to a curved or bent portion or intermediate portion 322.

[0170] Curved or bent portion or intermediate portion 322 may include a curve or bend that angles first tapered portion 320 relative to second tapered portion 324. Intermediate portion 322 may angle first tapered portion 320 relative to second tapered portion 324 such that second tapered portion 324 extends axially. The angle of intermediate portion 322 may be, for example, 70 degrees, or may be a greater angle (e.g., 80, 90, 100, 110 degrees) to vary the angle between first tapered portion 320 and second tapered portion 324. Second tapered portion 324 may be tapered at a second angle (this angle is more clearly shown in FIGS. 54 and 55 ) that is different from the first angle (the angle of first tapered portion 320). In some examples, second tapered portion 324 may taper radially inward (as shown in FIG. 55 ). As shown in FIGS. 54 and 55 , second tapered portion 324 may be angled such that it extends radially inward from intermediate portion 322 toward distal end 326 of outer frame 306. The angle of second tapered portion 324 may be a linear angle (e.g., a linear angle as depicted in FIG. 55 ), or second tapered portion 324 may have a curvature, in some examples. Other configurations of the outer frame (e.g., other forms of the outer frame disclosed herein) may be utilized as desired.

[0171] In some examples, the outer frame 306 has a tapered shape such that the downstream or distal end portion 316 has a smaller diameter than the intermediate portion 322 of the outer frame 306. The intermediate portion 322 may have a diameter ranging from about 35 millimeters to about 60 millimeters, for example, and the distal end portion 316 has a smaller diameter.

[0172] The outer frame 306 may include one or more gripping features 173 as disclosed herein. The gripping features 173 may be configured similarly to the gripping feature 173 shown in FIG. 29A or any other form of gripping feature disclosed with respect to FIGS. 19-31 . The gripping features 173 may operate in a manner similar to that described with respect to any of the examples in FIGS. 19-31 , as desired. The gripping features, in some examples, may include barbs (or may have other forms disclosed herein). The barbs may be positioned along the struts of the outer frame 306. The barbs may extend through the seal skirt 308 to penetrate the tissue of the native heart valve. In some examples, the prosthetic valve 280 may include any of the gripping features in FIGS. 32-43 , as desired. Any other features in any other examples disclosed herein may be utilized.

[0173] 49 , the sealing skirt 308, or outer skirt, may extend over the outer surface 307 of the outer frame 306 from the proximal end portion 314 of the outer frame 306 to the distal end portion 316 of the outer frame 306. The sealing skirt 308 may comprise a continuous or single piece of material or fabric that extends along the outer surface 307 of the outer frame 306 from the proximal end portion 314 to the distal end portion 316. A suture or stitch line 330 is shown at the proximal end portion 328 of the prosthetic valve 280, joining the proximal end 331 of the sealing skirt 308 to the proximal end 333 of the inner skirt 332 (shown in FIG. 53 ).

[0174] 50 , the distal end 335 of the sealing skirt 308 or outer skirt may be joined to the distal end 337 of the inner skirt 332 at the distal end portion 340 of the prosthetic valve 280. A suture or stitch line 342 may be positioned at the distal end portion 340 of the prosthetic valve 280. The sealing skirt 308 or outer skirt may extend across or span a gap 344 between the distal end portion 300 of the inner frame 292 and the distal end portion 316 of the outer frame 306. The suture or stitch line 342 may be positioned in a location that may improve ease of assembly of the prosthetic valve 280 because the suture or stitch line 342 may be more easily accessible to the distal end portion 340 of the prosthetic valve 280 compared to an interior portion (e.g., the interior surface facing the flow channel 284).

[0175] FIG. 53 illustrates the configuration of the inner skirt 332. The inner skirt 332 may extend from the proximal end portion 298 of the inner frame 292 to the distal end portion 300 of the inner frame 292. The prosthetic leaflets 282 may be sutured to the inner skirt 332 or otherwise attached to the inner skirt 332. A suture or stitch line 345 is shown between the prosthetic leaflets 282 and the inner skirt 332. The inner skirt 332 may extend along the inner or radially inward surface of the inner frame 292. The inner skirt 332 may include any of the features or configurations of the skirts disclosed with respect to FIGS. 1-7G , including materials to reduce or promote tissue or thrombus formation. The outer or sealing skirt 308 may include any of the features or configurations of the skirts disclosed with respect to Figures 1-7G, including materials to reduce or promote tissue or thrombus formation. In some examples, other configurations of the skirt may be utilized.

[0176] The anchor 304 may include features of any other anchor configuration disclosed herein unless otherwise stated. The anchor 304 may, for example, have a hook shape or may be a hook arm anchor as disclosed with respect to FIGS. 1-11. The anchor 304 may include features of anchors 44, 126 unless otherwise stated. The anchor 304 may include features of any other anchor (e.g., the anchors disclosed with respect to FIGS. 12-48 unless otherwise stated). The anchor 304 may be coupled to the distal end portion 300 of the inner frame 292. The anchor 304 may extend radially outward from the distal end portion 300 of the inner frame 292 and may extend across or span the gap 344 between the distal end portion 300 of the inner frame 292 and the distal end portion 316 of the outer frame 306. The anchors 304 are adapted to anchor to the native valve by hooking onto the native valve leaflets. The distal end portion 300 of the inner frame 292 is spaced apart from the distal end portion 316 of the outer frame 306 by a gap 344.

[0177] 54 , each of the anchors 304 may include a connecting portion 346, a drop loop 348 positioned radially outward from the connecting portion 346, and a tip portion 350 including a tip 352 of the corresponding anchor 304. The tip portion 350 may extend from the drop loop 348 toward the axially proximal, or inflow, portion of the prosthetic valve 280. The drop loop 348 may include a curved or bent portion that may angle the connecting portion 346 relative to the tip portion 350. Each of the anchors 304 protrudes radially outward from the outer surface of the valve body 286. In some examples, the tip 352 of each corresponding anchor 304 may be positioned radially outward from the outer surface 307 of the outer frame 306 (and the outer surface of the seal skirt 308). The tip 352 of each corresponding anchor 304 may overlap the outer surface 307 of the outer frame 306 (and the outer surface of the seal skirt 308). Referring to FIG. 49, the tips 352 of the anchors 304 may be positioned between the “V” shaped openings in the struts of the outer frame 306 .

[0178] 54 illustrates a cross-sectional view of the prosthetic valve 280, showing the skirt 356 (the combination of the sealing skirt 308 and the inner skirt 332) of the prosthetic valve 280 positioned over the frame 358 (the combination of the inner frame 292 and the outer frame 306) of the prosthetic valve 280. In some examples, the skirt 356 may be tightly coupled to the frame 358 of the prosthetic valve 280 such that the skirt 356 applies tension to the frame 358. The tension that the skirt 356 applies to the frame 358 may create or alter a tapered shape of the outer frame 306. The tension may be applied by the anchors 304 in combination with or instead of the skirt 356, in some examples.

[0179] The resulting tapered shape of the outer frame 306 may be tapered as shown in FIGS. 54 and 55 due to the tension provided by the skirt 356. Such a configuration may have various advantages. Referring to FIG. 55, for example, the taper of the second tapered portion 324 may be linearly angled radially inward (e.g., linearly angled). A wide, linear, continuous contact area 360 (forming a frustoconical shape with respect to the contact area of ​​the prosthetic valve 280 around the periphery of the valve 280) against the native valve leaflets 362 or against other portions of the native valve (e.g., the annulus) may be provided. Improved sealing against the native valve leaflets 362 or against other portions of the native valve may be achieved. Annular engagement is improved. Furthermore, the tip portion 350 of the anchor 304 may be linear and may match or have the same angle as the angle of the second tapered portion 324. Thus, improved contact between the tip portion 350 and the outer surface of the outer body 290 may be achieved. The native valve leaflets 362 may be compressed or clamped between the tip portion 350 and the outer surface of the outer body 290. Compression may occur, for example, between the outer surface 307 of the outer frame 306 and the outer surface of the seal skirt 308 or outer skirt. The tip portion 350 and / or the outer body 290 may be biased into contact with or pressed against one another to provide compression or clamping of the native valve leaflets 362. Compression or clamping configurations such as those disclosed in FIGS. 19-31 may be utilized.

[0180] The configuration shown in Figure 55 may differ in having a double or "S" curvature (having a first curve shown at 371 and an opposite second curve shown at 372) compared to a configuration including a protruding shoulder 370 forming a radially outwardly convex or parabolic protruding rib (having such a profile shown in dashed lines in Figure 55). Thus, a protruding shoulder forming a circumferentially extending rib around the prosthetic valve may be eliminated. A single direction of bending for the curved or bent portion 322 may be utilized.

[0181] Each feature of the prosthetic valves of Figures 49-55 may be utilized alone or in combination with any other example disclosed herein.

[0182] Variations in the configuration of the prosthetic valve 280 may be provided. Figure 56, for example, illustrates a variation in which the outer frame 306 is not directly coupled to the inner frame 292. The proximal end portion 314 of the outer frame 306 is not directly coupled to the proximal end portion 298 of the inner frame 292. Furthermore, the distal end portion 316 of the outer frame 306 is not directly coupled to the distal end portion 300 of the inner frame 292.

[0183] FIG. 57 illustrates a plan view of the separation between the outer frame 306 and the inner frame 292, or the lack of direct contact or direct coupling therebetween.

[0184] 58 and 59 , the connection between the frames 292, 306 may be provided by a flexible body, connecting member, connecting skirt, or intermediate component 380 that may extend between the proximal end portion 298 of the inner frame 292 and the proximal end portion 314 of the outer frame 306. The intermediate component 380 may allow movement of the inner frame 292 relative to the outer frame 306. The connecting skirt or intermediate component 380 may include an extension of the seal skirt 308 or the inner skirt 332 and may extend radially between the proximal end portion 298 of the inner frame 292 and the proximal end portion 314 of the outer frame 306. Thus, the outer frame 306 may be coupled to the inner frame 292 by the connecting skirt or intermediate component 380 and by the distal end portion 382 of the prosthetic valve skirt 384. The connecting skirt or intermediate component 380 may comprise a proximal end portion of the skirt 384, and the distal end portion 382 of the skirt 384 may comprise a connecting skirt for the distal end portions 300, 316 of the frames 292, 306. The connecting skirt or intermediate component 380 and the distal end portion 382 of the skirt 384 may comprise a flexible tether connection between the proximal end portion 298 of the inner frame 292 and the proximal end portion 314 of the outer frame 306.

[0185] The flexible connection provided by the connecting skirt or intermediate component 380 and the distal end portion 382 of the skirt 384 may allow the outer frame 306 to move axially relative to the inner frame 292 and tilt laterally relative to the inner frame 292. Conformity and adaptability to the shape of the native valve may be improved. Therefore, sealing against the native valve may be improved. Furthermore, radial stiffness may be reduced.

[0186] Each feature of the prosthetic valves of Figures 56-59 may be utilized alone or in combination with any of the other examples disclosed herein.

[0187] Additional variations in the configuration of the prosthetic valve 280 may be provided. For example, Figures 60-63 illustrate variations in which an inner frame 390 (shown in perspective in Figure 62) includes two non-integrally formed portions 392, 394 (i.e., a first frame and a second frame). Figure 60 illustrates a side view of a first portion 392 including a sleeve or cylindrical portion of the inner frame 390, configured similarly to the inner frame 292 shown in Figure 51. The first portion 392 may include struts and may surround a flow channel for the prosthetic valve leaflet 282. The first portion 392 extends axially from a proximal end portion 396 to a distal end portion 398. The first portion 392 includes a sleeve portion that supports the artificial valve leaflet 282, and the features of the proximal end portion 396 and the distal end portion 398 correspond to the corresponding features of the proximal end portion 298 and the distal end portion 300 of the inner frame 292, respectively.

[0188] A perspective view of second portion 394, or second frame, is shown in FIG. 61. Second portion 394 may include a support frame 400 coupled to an anchor 402, which may be configured similarly to anchor 304 unless otherwise noted. Support frame 400 may include a ring to enclose a flow channel for prosthetic valve leaflets 282. Support frame 400 may include a plurality of longitudinally extending struts 404 with openings 406 surrounded by struts 404 located therebetween. Second portion 394 may include struts of a ventricular anchor.

[0189] The second portion 394 may be made of a material having a thinner radial thickness 410 (shown in FIG. 63 ) compared to the thickness 412 (shown in FIG. 63 ) of the material forming the first portion 392. A thinner radial thickness is utilized. Thus, each component shown in FIG. 61 may have a thinner radial thickness 410 compared to the thickness 412 of each component shown in FIG. 60 . This feature may advantageously reduce the stiffness of the arms forming the anchor 402 of FIG. 61 , thereby increasing compliance with the implantation site. The anchor 402 may be more easily deflectable inward and outward and may have reduced radial stiffness. The first portion 392 shown in FIG. 60 may have greater stiffness to support the prosthetic valve leaflet 282 having the flow channel.

[0190] First portion 392 may be coupled to second portion 394, as shown in FIG. 62, for example. First portion 392 may be coupled to second portion 394 by a suture connection or other form of coupling. Support frame 400 may be positioned at a distal end portion 398 of inner frame 390 and may be positioned radially inward (or, in some examples, radially outward) from inner frame 390. Anchors 402 may protrude radially outward.

[0191] FIG. 63 illustrates a cross-sectional view of a prosthetic valve utilizing an inner frame 390.

[0192] Each feature of the prosthetic valve of Figures 61-63 may be utilized alone or in combination with any other example disclosed herein.

[0193] Additional variations in the configuration of the prosthetic valve 280 may be provided. In some examples, the prosthetic valve may be configured such that the utilized anchors have a smaller radius compared to the outer surface of the outer body. In some examples, the anchors may be housed or nested within the outer body.

[0194] For example, referring to FIG. 64A, a top view of a configuration of frame 420 is shown, including an outer frame 422 having recesses, pockets, or depressions 424 for receiving tips 426 of anchors 428. Anchors 428 may be configured similarly to anchors 304 unless otherwise noted.

[0195] The recesses 424 may include arcuate portions of the outer frame 422 that project radially inward from an outermost surface 430 of the outer frame 422. The recesses 424 may be circumferentially spaced apart from one another around the outer surface of the outer frame 422 and may be positioned to circumferentially align with the locations of the anchors 428. The recesses 424 may be elongated and extend axially along the outer frame 422. Axially extending concave recesses 424 may be utilized to receive the anchors 304. The circumferential width 432 of each recess 424 may be greater than or equal to the width of each tip 426. The radial depth 434 of each recess 424 may be greater than or equal to the radial thickness of each tip 426 of the anchors 428. Each recess 424 may be configured to receive a tip 426 of an anchor 428, where tip 426 has a smaller radius than an outermost surface 430 of outer frame 422. In some examples, recesses 424 may be configured such that tip 426 of anchor 428 is partially or at least partially recessed inwardly from outer frame 422.

[0196] Figure 64B illustrates a side perspective view of the configuration shown in Figure 64A. Figure 65 illustrates a perspective view of a prosthetic valve 431 utilizing frame 420, in which sealing skirt 308 is positioned on the outer surface of outer frame 422. Figure 66 illustrates a side cross-sectional schematic view of tip 426 positioned within recess 424. Tip 426 is shown protruding at a smaller radius compared to the radius of outermost surface 430 of outer frame 422. Sealing skirt 308 may be positioned between tip 426 and outer frame 422.

[0197] 64A-66 may advantageously reduce the outer profile or diameter of the prosthetic valve. Outward radial forces may be reduced. One or more leaflets engaged by anchors 428 may be pressed into and secured within corresponding recesses 424. In some examples, the leaflets may be secured within the space between tips 426 of anchors 428 and outer frame 422 by utilizing gripping features disclosed herein (e.g., those disclosed in FIGS. 19-31 and 52, or other configurations of gripping features).

[0198] Each feature of the prosthetic valves of Figures 64A-66 may be utilized alone or in combination with any other example disclosed herein.

[0199] Alternative configurations may be provided in which the utilized anchor has a smaller radius compared to the outer surface of the outer body, or in which the anchor is housed or nested within the outer body.

[0200] Referring to FIG. 67 , a perspective view of a prosthetic valve 440 is shown. The prosthetic valve 440 may include each feature of the prosthetic valve 280 unless otherwise noted. The prosthetic valve 440 includes anchors 442, each having a tip 444 positioned distally from the outer frame 306 (shown in FIG. 70 ). The distal (i.e., outflow) location of the tip 444 from the outer frame 306 allows the tip 444 to protrude to a radius less than or equal to the radius of the outer frame 306. Axial clearance exists between the tip 444 and the outer frame 306. The outer frame 306 does not prevent the tip 444 from being positioned less than or equal to the radius of the outer frame 306.

[0201] 67 may be provided in various ways. In some examples, the relative axial height of the distal end of the outer frame 306 and the tip 444 may be offset such that the tip 444 is positioned distally of the outer frame 306. In some examples, the axial height of the anchor 442 may be reduced relative to the height of the anchor 304 shown in FIG. 49. The reduced axial height allows the tip 444 to be retracted or nested below or distal to the struts of the outer frame 306. In some examples, the axial height of the outer frame 306 may be adjusted such that the distal end of the outer frame 306 is positioned proximal to the tip 444, allowing the tip 444 to be retracted or nested distally to the struts of the outer frame 306.

[0202] The radial extent or outer profile of the prosthetic valve 440 may be reduced compared to the prosthetic valve 280 shown in Figure 49. Figure 68 illustrates a plan view of the prosthetic valve 440, illustrating that the tip 444 does not protrude beyond the outer surface of the outer frame 306. The outer profile or outer diameter of the prosthetic valve is reduced. Outward radial forces may be reduced.

[0203] FIG. 69 illustrates a plan view of the outer frame 306 and inner frame 292, where the tips 444 of the anchors 442 have the reduced height shown in FIG. 67. The tips 444 are positioned radially inward from the outer surface 307 of the outer frame 306. In some examples, the tips 444 may be positioned radially inward from the outer surface 307 or may be located at the same radius. For example, although the outer frame 306 may be compressed radially inward by a skirt disclosed herein, the tips 444 may remain below the outer diameter of the outer frame 306, as shown in FIG.

[0204] 70 illustrates a side view of a tip 444 positioned distally from the outer frame 306. The tip 444 is positioned distally from a distal-most strut 446 of the outer frame 306. The distal-most struts 446 may extend axially and surround an opening 448, or distal-most opening, positioned between adjacent distal-most struts 446. The tip 444 may be positioned within the opening 448 in a configuration as shown and described with respect to FIG. 28. In some examples, the tip 444 may be positioned distally from the opening 448.

[0205] FIG. 71 illustrates a cross-sectional schematic side view of the configuration shown in FIG. 70. A skirt (e.g., sealing skirt 308) may be positioned radially inward from tip 444 as disclosed herein. The native valve leaflets may be positioned between tip 444 and the skirt and clamped in place. In some examples, a gripping feature as disclosed herein (e.g., those disclosed in FIGS. 19-31 and 52, or other configurations of a gripping feature) may be utilized for additional fixation of the native valve leaflets. FIG. 70 illustrates a gripping feature 173 positioned proximate tip 444, for example, in the configuration shown in FIG. 28. The gripping feature 173 may be utilized in the manner disclosed herein.

[0206] In some examples, the tip 444 may be partially recessed, or at least partially recessed, relative to the outer surface 307 of the outer frame 306 .

[0207] Each feature of the prosthetic valve of Figures 67-71 may be utilized alone or in combination with any other example disclosed herein.

[0208] 72-75 illustrate a variation in which some of the anchors of the prosthetic valve 450 include the anchors 442 described with reference to FIGS. 67-71 and some of the anchors include the anchors 304 of the prosthetic valve 280. Each of the anchors 304 has a tip 352 that is positioned radially outward from the outer frame 306 and overlaps the outer surface 307 of the outer frame 306. Such a configuration is shown, for example, in FIG. 26. Each of the anchors 442 has a tip 444 that is positioned distally from the outer frame 306, as described with reference to FIGS. 67-71. Each of the anchors 442 may protrude to a radius smaller than the radius of the outer surface 307 of the outer frame 306. The anchors 442 have a tip that is at least partially recessed radially inward from the outer surface of the prosthetic valve. Other features of the anchors 442 described with reference to FIGS. 67-71 may also be utilized.

[0209] Anchors 304, 442 may be coupled to inner frame 292 in the configuration depicted in FIG. 72. Thus, the height of anchors 304, 442 may be offset such that tip 444 of anchor 442 extends at a lower axial height 451 in a proximal-facing direction (i.e., toward the inflow direction) compared to tip 352 of anchor 304.

[0210] In some examples, the height offset of tips 352, 444 may be created due to a height offset 452 between drop loop 348 of anchor 304 and drop loop 454 of anchor 442. Drop loop 454 of anchor 442 protrudes axially in a distal direction relative to the location of drop loop 348 of anchor 304. This feature causes anchor 442 to extend in a distal direction (i.e., toward the outflow), thereby reducing the height of tip 444. Thus, the height of tip 444 is correspondingly reduced without a corresponding or equivalent reduction in the length of tip portion 456.

[0211] In some examples, at least one of the anchors of the prosthetic valve includes anchor 304, and at least one of the anchors includes anchor 442. In some examples, anchor 442 may be positioned at a desired location around the circumference of the prosthetic valve to reduce the radial extent or outer profile of the prosthetic valve at that location.

[0212] For example, referring to FIG. 73 , a schematic plan view of a prosthetic valve 450 is shown in which a circumferential portion 462 includes anchors 442 and a portion 464 includes one or more anchors 304. In some examples, portion 462 may be positioned to reduce the radial extent or outer profile of prosthetic valve 450 at portion 462. In examples in which prosthetic valve 450 includes a prosthetic tricuspid valve, portion 462 may include a septal side of prosthetic valve 450 adapted to face the septal side of the native tricuspid valve. Thus, radial pressure and possible electrical conduction obstructions due to the tricuspid valve may be reduced at portion 462. In other examples, other configurations may be utilized.

[0213] The relative sizes of portions 462, 464 may vary, in some examples. As depicted in FIGS. 73 and 74 , portion 464 may comprise at least 200 degrees of the circumference of prosthetic valve 450. Thus, portion 462 may comprise 160 degrees or less. In some examples, portion 464 may comprise at least 180 degrees of the circumference. Portion 462 may comprise 180 degrees or less. In some examples, various other proportions (e.g., larger or smaller sizes of portions 462, 464) may be utilized. Portions 462, 464 may comprise respective arcs spanning the entire circumference of prosthetic valve 450. Portions 462, 464 are circumferentially adjacent to one another around the circumference of prosthetic valve 450.

[0214] In some examples, portion 464 may include at least two of anchors 304, or at least three of anchors 304, or other quantities (e.g., at least four, five, etc.). Portion 462 may include at least two of anchors 442, or at least three of anchors 442, or other quantities (e.g., at least four, etc.). FIG. 74, for example, illustrates a configuration of anchors 304, 442 where portion 464 includes five anchors 304 and portion 462 includes four anchors 442. Anchors 304, 442 are equally circumferentially spaced from one another. In some examples, unequal circumferential spacing may be utilized.

[0215] FIG. 75 illustrates a cross-sectional view of prosthetic valve 450, illustrating the use of both anchors 304 and 442. Anchors 304, 442 are configured asymmetrically, with portion 462 of prosthetic valve 450 utilizing anchor 442 and portion 464 utilizing anchor 304. In some examples, anchors 304, 442 may be pressed against a gripping feature disclosed herein (e.g., those disclosed in FIGS. 19-31 and 52, or other configurations of the gripping feature). The gripping feature may be utilized to secure the leaflets within the space between the corresponding tip of the anchor and outer frame 306. For example, tip 352 of anchor 304 may overlap the gripping feature to press the native leaflets toward the gripping feature, thereby reducing movement of the leaflets relative to valve body 453.

[0216] Each feature of the prosthetic valves of Figures 72-75 may be used alone or in combination with any other example disclosed herein. Alternative configurations may be provided in which the anchors utilized have a smaller radius than the outer surface of the outer body, or in which the anchors are housed or nested within the outer body. Figure 76, for example, illustrates a top view schematic of a prosthetic valve 470 configuration utilizing anchors 304 and anchors 472 having a smaller axial height than anchors 304. Each of anchors 472 has a height such that the tip of anchor 472 is located distal to outer frame 474 of prosthetic valve 470. Outer frame 474 has an elliptical outer profile (or a non-uniform circular outer profile) such that portion 476 of outer frame 474 extends fully or partially onto anchor 472. Thus, the radial extent of anchor 472 from the outer surface of outer frame 474 is reduced. The outer frame 474 may extend outwardly with a larger diameter radial portion 476 for at least one-third of the prosthetic valve 470. In some instances, other proportions may be utilized. The portion 476 may, in some instances, have wider strut openings to accommodate the tips of any of the anchors disclosed herein.

[0217] Each feature of the prosthetic valve of FIG. 76 may be utilized alone or in combination with any other example disclosed herein.

[0218] Additional variations in the configuration of the prosthetic valve 280 may be provided. Figures 77-86, for example, illustrate variations in which one or more clasp anchors 480 may be utilized. Figure 77 illustrates a side perspective view of the inner frame 292, showing the clasp anchor 480 coupled to the distal end portion 300 of the inner frame 292. An anchor 304 may be coupled to the inner frame 292.

[0219] A prosthetic valve 482 (shown in FIG. 79 ) utilizing one or more clasp anchors 480 may be divided into multiple sections in a manner similar to that disclosed with respect to FIGS. 73 and 74 . For example, referring to the schematic plan view of FIG. 78 , the circumference of the prosthetic valve 482 may be divided into a section 484 including the clasp anchor 480 and a section 486 including one or more anchors 304. The section 484 may be located on the opposite side of the section 486. In some examples, the section 484 may be positioned to reduce the radial extent or outer profile of the prosthetic valve at that section 484. In examples where the prosthetic valve 482 includes a prosthetic tricuspid valve, the section 484 may include a septal side of the prosthetic valve 482 adapted to face the septal side of the native tricuspid valve. Thus, radial pressure and possible electrical conduction disturbances due to the tricuspid valve may be reduced at the section 484. In other examples, other configurations may be utilized.

[0220] The relative sizes of portions 484, 486 may vary, in some examples. As depicted in FIG. 78 , portion 486 may comprise at least 200 degrees of the circumference. Thus, portion 484 may comprise 160 degrees or less. In some examples, portion 486 may comprise at least 180 degrees of the circumference. Portion 484 may comprise 180 degrees or less. In some examples, various other proportions (e.g., larger or smaller sizes of portions 484, 486) may be utilized. Portions 484, 486 may comprise respective arcs spanning the entire circumference of prosthetic valve 482. Portions 484, 486 are circumferentially adjacent to one another around the circumference of prosthetic valve 482.

[0221] In some examples, portion 486 may include at least two of anchors 304, or at least three of anchors 304, or other quantities (e.g., at least four, five, etc.). Portion 484 may include at least two of clasp anchors 480, or at least three of clasp anchors 480, or other quantities (e.g., at least four, etc.). FIG. 78, for example, illustrates a configuration of anchors 304, 442 where portion 486 includes five anchors 304 and portion 484 includes two clasp anchors 480. The anchors 304 are shown spaced evenly apart from one another, and the clasp anchors 480 are shown spaced evenly apart from one another. In some examples, unequal circumferential spacing may be utilized.

[0222] 79 illustrates a perspective view of the prosthetic valve 482. The clasp anchors 480 are coupled to the valve body 286. Each of the clasp anchors 480 includes a tip 490 adapted to overlap the outer surface 307 of the outer frame 306 and to anchor to the native valve by clamping a portion of the native valve (e.g., the native valve leaflets) between the tip 490 and the outer surface 307 of the outer frame 306. The clasp anchors 480 are adapted to clamp the native valve leaflets against the outer surface 287 of the valve body 286. The clasp anchors 480 are spring biased radially inward toward the center of the prosthetic heart valve.

[0223] FIG. 80 illustrates a flattened pattern of the inner frame 292, showing that the arms of the anchors 304 extend distally from the distal end portion 300 of the inner frame 292 in an elongated configuration. The distal end portion 300 includes a coupler 492 for coupling to a clasp anchor 480. FIG. 81 illustrates a plan view of the arms of the clasp anchor 480. The clasp anchor 480 extends longitudinally to a tip 490 of the clasp anchor 480. The clasp anchor 480 includes a coupler 494 for coupling to the coupler 492 of the inner frame 292. The clasp anchor 480 may include windows or openings 495, 497 to reduce the material comprising the clasp anchor arms and, if desired, to receive heart valve leaflet tissue therein. The couplers 492, 494 may be coupled using sutures or other forms of coupling, as desired.

[0224] The clasp anchor 480 may be shaped to curve toward the outer frame 306. Referring to FIG. 82 , for example, the clasp anchor 480 may be shaped to curve proximally and thus press radially inward toward the outer frame 306. The clasp anchor 480 may overlap the outer frame 306, as shown in FIG. 82 . Deflection of the clasp anchor 480 may create a drop loop 500, as shown in the cross-sectional view of FIG. 86 . The drop loop 500 may create a spring bias, which may be similar to the bias of a torsion spring, to orient the tip 490 toward and towards the outer frame 306. The clasp anchor 480 may be spring biased toward the valve body 286.

[0225] In some examples, the tip 490 may have a circumferentially planar shape, which creates a flat profile relative to 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 depicted in the schematic diagram of FIG. 78. Thus, the outer profile of the prosthetic valve 482 may be reduced.

[0226] The configuration of clasp anchor 480 may be varied, in some examples. FIG. 83 , for example, illustrates a variation in which clasp anchor 504 includes a flexible portion 502, thereby increasing the flexibility of anchor 504 at flexible portion 502. Flexible portion 502 may include an undulating or axial pattern of arms at portion 502. Clasp anchor 504 may otherwise be configured similarly to clasp anchor 480 and may include tip 505 and coupler 506 for coupling to coupler 492. A window or opening 507 may be positioned in tip 505.

[0227] Figure 84 illustrates a variation in which the clasp anchor 510 is configured similarly to the clasp anchor 504, but includes an additional barbed clasp 512 that can be positioned at the location of the grasping feature 173 shown in Figure 82. The barbed clasp 512 can be positioned to engage against the native valve leaflets when the clasp anchor 510 is occluded.

[0228] 85 illustrates a linear configuration of clasp anchor 514 including arms 516 with tips 518 having windows or openings 520. Clasp anchor 514 includes a top clasp 522 and a coupler 524 for coupling to coupler 492.

[0229] FIG. 86 illustrates a cross-sectional view of a prosthetic valve 482 showing a clasp anchor 480 positioned against an outer surface 287 of a valve body 286 .

[0230] Variations in the coupling of clasp anchor 480 may be provided. For example, FIG. 87 illustrates a variation in which clasp anchor 530, configured similarly to clasp anchor 480, is coupled to outer frame 306. Clasp anchor 530 may be coupled to distal end portion 316 of outer frame 306.

[0231] Additionally, in some examples, the gripping features disclosed herein (e.g., those disclosed in FIGS. 19-31 and 52, or other configured gripping features) may be utilized to secure the leaflets in the space between either the clasp anchors and anchors 304 and the outer frame 306 in the manner disclosed herein. The clasp anchors or anchors 304 may overlap the outer frame 306 with the gripping features, or clamping may be accomplished in other manners.

[0232] Further variations may be provided for any example of a prosthetic valve disclosed herein. In some examples, any of the anchors disclosed herein (which may include hook arm anchors or clasp anchors) may be omitted from a portion of any prosthetic valve such that the remaining anchors are unevenly spaced. One or more anchors may be omitted along the periphery of the prosthetic valve. Anchors may be omitted on the septal portion of a prosthetic valve deployed in a tricuspid valve configuration. In some examples, a portion of a prosthetic valve disclosed herein, such as one having at least partially recessed anchors or one having clasp anchors, may have anchors omitted entirely.

[0233] 88-90 illustrate an exemplary deployment sequence of a prosthetic valve 482 relative to a native heart valve. FIG. 88 illustrates anchors 304, 480, respectively, in a straightened, extended, or compressed configuration within a capsule 540 of a delivery system or catheter. Clasp anchor 480 may have a longer length than anchor 304 in the straightened, extended, or compressed configuration. Capsule 540 is positioned in proximity to a native heart valve, which may be a native tricuspid valve in this example. The native heart valve may include valve leaflets 91 a, b.

[0234] 89 illustrates a partially deployed prosthetic heart valve 482 in which the anchors 304 are partially deployed and the clasp anchors 480 extend radially outward from the capsule 540. In the partially deployed configuration, the clasp anchors 480 may capture the native valve leaflets 91 a and press the leaflets 91 a against the outer surface of the capsule 540. The capsule 540 may be retracted from this position, as shown in FIG. 90, for example, to allow the clasp anchors 480 to press the leaflets 91 a against the outer surface 287 of the valve body 286.

[0235] FIG. 90 illustrates a deployed configuration of a prosthetic heart valve 482 in which clasp anchors 480 clamp the valve leaflets 91 a against the outer surface 287 of the valve body 286 .

[0236] Variations regarding the delivery system may be provided. For example, Figure 91 illustrates a variation in which delivery system 550 includes a tether 552 coupled to clasp anchor 480 for controlling the closure and / or opening of clasp anchor 480. Tension on tether 552 may be applied to open clasp anchor 480, and tension on tether 552 may be released to close clasp anchor 480. In this manner, control over opening and closing of clasp anchor 480 may be provided.

[0237] Tether 552 may extend into a shaft of delivery system 550, such as guidewire lumen 554, or into another shaft of delivery system 550. Tether 552 may pass through a channel in the shaft to a proximal end portion of delivery system 550 for actuation. Proximal end portion 556 of tether 552 may be actuated at a handle of delivery system 550 or at another ex vivo portion of delivery system 550.

[0238] In some examples, the prosthetic heart valve 482 may include only clasp anchors distributed circumferentially around the prosthetic heart valve 482 (no hook arm anchors are provided).

[0239] Each feature in the examples of Figures 77-91 may be used alone or in combination with any other example disclosed herein.

[0240] Additional variations in the configuration of the prosthetic valve 280 may be provided. Figures 92-96 illustrate variations in which the prosthetic valve 600 includes one or more support arms 602. The prosthetic valve 600 may include each feature of the prosthetic valve 280 unless otherwise noted. Each of the support arms 602 may have a proximal end portion 604 coupled to a valve body 606 and a distal end portion 608 projecting axially distally, i.e., in the outflow direction, from the valve body 606. The support arms 602 may project from a distal end portion 607 of the valve body 606. The support arms 602 may extend distally, i.e., in the outflow direction, to a tip 609 of the corresponding support arm 602.

[0241] The support arm 602 may be positioned at a portion 610 of the prosthetic valve 600. The prosthetic valve 600 may be divided into portions in a manner similar to that described with respect to FIGS. 73 and 78 . For example, the prosthetic valve 600 may include a portion 610 and a portion 612 that includes the anchor 304. The portions 610, 612 may be located opposite each other. The relative sizes of the portions 610, 612 may vary in some examples. For example, the portion 612 may include at least 200 degrees of the circumference of the prosthetic valve 600. Thus, the portion 610 may include 160 degrees or less. In some examples, the portion 612 may include at least 180 degrees of the circumference. The portion 610 may include 180 degrees or less. In some examples, various other proportions (e.g., larger or smaller sizes of the portions 610, 612) may be utilized. The portions 610, 612 may comprise respective arcs that span the entire circumference of the prosthetic valve 600. The portions 610, 612 are circumferentially adjacent to one another around the circumference of the prosthetic valve 600.

[0242] The support arms 602 may extend at circumferential portion 610. The prosthetic valve 600 may not include hook arm anchors that project radially outward from the outer surface of the valve body at portion 610. The number of support arms 602 may vary from at least one to at least two to at least three or more. The anchors 304 may include at least one, at least two, at least three, or more (e.g., six are shown in FIG. 92).

[0243] For deployment in the tricuspid valve, portion 610 may be configured to be positioned on the septal side of the tricuspid valve, thereby creating a reduced radial profile on the septal side of the tricuspid valve, which may reduce the likelihood of electrical conduction obstruction across the tricuspid valve.

[0244] In deployment in a native valve between the atrium and ventricle of the heart, the support arms 602 may be adapted to extend into the ventricle. The support arms 602 may be adapted to stabilize the prosthetic valve 600 within the native valve. For example, the support arms 602 may contact the heart wall within the ventricle to stabilize the prosthetic valve 600, or may be otherwise positioned to stabilize the prosthetic valve 600. The support arms 602 may reduce tilting or swaying of the prosthetic valve 600 during beating movements of the heart due to the lack of a hook anchor in the portion 610. In this manner, the support arms 602 may take into account the lack of a hook anchor in the portion 610.

[0245] The support arms 602 may extend from the inner frame 292 (as shown in FIG. 92 ) or, in some examples, from the outer frame 306. The support arms 602 may be coupled to a distal end portion of the inner frame 292 or to a distal end portion of the outer frame 306, for example.

[0246] Support arm 602 may, in some examples, be configured with the structure of anchor 304, but may be shaped to project distally or in the outflow direction. Thus, support arm 602 may include anchor 304 that is not shaped to form a hook, but rather is shaped to extend axially or linearly. Other configurations for support arm 602 may be utilized in some examples.

[0247] In some examples, the outer surface 614 of the valve body 606 may include a friction element 616. The friction element 616 is adapted to provide friction against the native heart valve, for example, against the native valve leaflets or annulus. The friction element 616 shown in FIGS. 92 and 93 includes a plurality of barbs 618, which may be positioned on a sheet 620 of material. The barbed sheet 620 is shown in isolation in FIG. 94. The sheet 620 may include a plurality of arms 622 surrounding an opening 624. The barbs 618 may be positioned on the arms 622. In some examples, the barbs 618 may be flattened or flush with the sheet 620, such that the barbs 618 do not protrude radially outward from the sheet 620. The barbs 618 may extend parallel to the plane of the outer surface of the valve body 606. Barbs 618 flush with seat 620 may reduce the likelihood of barbs 618 damaging the deployment capsule during release of prosthetic valve 600 from the capsule. In some examples, barbs 618 may be configured to project radially outward from seat 620, or other configurations may be provided. Arms 622 may be shaped to match the shape of struts of outer frame 306, in some examples.

[0248] The seat 620 may be positioned on the exterior surface 614 of the valve body 606, as shown in Figures 92 and 93. In some examples, the seat 620 may be positioned within the skirt 308, and the barb 618 may be adapted to protrude through the skirt 308.

[0249] In some examples, other configured friction elements may be utilized, such as roughened surfaces on the outer frame or outer skirt, napped fabrics, or other configured barbs.

[0250] 95 and 96 illustrate an exemplary deployment sequence. Referring to FIG. 95, anchor 304 is shown in a straightened or extended or compressed configuration, and support arm 602 is similarly shown extending into delivery capsule 630. The delivery capsule may be retracted in a manner similar to that disclosed herein, whereupon anchor 304 is inverted or rotated to latch onto leaflet 91b. Support arm 602 may continue to protrude axially due to its shape setting.

[0251] 96 , for example, anchor 304 is hooked onto leaflet 91b with support arm 602 protruding axially into the ventricle to stabilize prosthetic valve 600. Support arm 602 may be positioned adjacent to or contacting the ventricular heart wall 632. Support arm 602 may contact the endocardial wall 632 within the ventricle to stabilize prosthetic valve 600 within the tricuspid valve. Tilting of prosthetic valve 600 may be reduced by the presence of support arm 602. Friction element 616 may secure portion 610 of prosthetic valve 600 in place by engaging leaflet 91a and / or the annulus. The possibility of atrial migration and emboli may be reduced.

[0252] In some examples, transjugular access of the prosthetic valve 600 may be utilized.

[0253] Each feature in the examples of Figures 92-96 may be used alone or in combination with any other example disclosed herein.

[0254] 97 illustrates a variation in which the support arm 602 includes a puncturing element 640 for puncturing the heart wall of the ventricle to secure the support arm 602 against the heart wall. The puncturing element 640 may include a barb, prong, or threaded tip, or other form of puncturing element, for puncturing tissue. The puncturing element 640 may be located at the tip of the support arm 602. When deployed, the puncturing element 640 may penetrate into the tissue of the heart wall.

[0255] Each example of a prosthetic valve may be used in a mitral or tricuspid valve as disclosed herein, or in other deployment locations. The prosthetic heart valve may be sized to replace a native tricuspid or mitral valve. Deployment in an aortic or pulmonary valve, or other implantation site, may also be used.

[0256] 98 illustrates an example of a delivery system 650. Features of the delivery system 650 that may be utilized are disclosed in U.S. Provisional Application Nos. 63 / 436,051, filed December 29, 2022, and 63 / 533,458, filed August 18, 2023, the entire contents of each of which are incorporated herein by reference. The delivery system 650 can be used to deploy the implants disclosed herein or other forms of implants. Implants, such as prosthetic heart valves, may be delivered to the subject's mitral or tricuspid valve annulus, or other heart valve location, in a variety of ways, including open surgery, minimally invasive surgery, and percutaneous or transcatheter delivery through the subject's vasculature. An exemplary transfemoral approach is further described in U.S. Patent Publication No. 2015 / 0238315, published August 27, 2015, which is incorporated herein by reference in its entirety. Although delivery system 650 is described in connection with a percutaneous delivery approach, and more specifically a transfemoral delivery approach, it will be understood that features of delivery system 650 may be applied to other delivery approaches, including delivery systems for transapical or transjugular delivery approaches.

[0257] A delivery system 650 may be used to deploy a prosthetic valve, such as a replacement heart valve described herein, to a location within a subject's body. The delivery system 650 may include multiple components, devices, or subassemblies. The delivery system 650 may include a delivery catheter or elongated catheter or delivery device 652, a stabilization assembly 654, and other components as desired. The delivery device 652 may include an elongated shaft or shaft assembly 656 and a housing in the form of a handle 658. The housing may be located at a proximal end portion of the elongated shaft or shaft assembly 656. The shaft assembly 656 may include one or more shafts. While multiple shafts may be provided according to examples herein, in some instances, a single shaft may be utilized. The shaft assembly 656 may include a capsule 660 that may hold the implant in a compressed configuration, and retracting the capsule 660 deploys the implant. In some instances, sutures may be attached to the implant and used to release the implant at the implantation site. A tether assembly may be used, for example, for release.

[0258] Percutaneous and transseptal implantation may be used. Tricuspid valve implantation may be used.

[0259] Figure 99 illustrates a schematic of a delivery approach for a native tricuspid valve. As shown in Figure 99, in one example, a delivery system can be placed in the ipsilateral femoral vein 704 and advanced toward the right atrium 706. This approach can be performed from the inferior vena cava (or from the superior vena cava), in some examples.

[0260] 99 illustrates a delivery system extending from the ipsilateral femoral vein 704 to the right atrium 706. In the example of the present disclosure, a guidewire is not required to properly position the delivery system, although in other examples, one or more guidewires may be used.

[0261] Thus, a user can advantageously navigate the delivery system through complex regions of the heart to position the replacement tricuspid valve in alignment with the native tricuspid valve. This can be accomplished with or without the use of a guidewire using the system disclosed above. The distal end of the delivery system can be advanced into the right atrium 706. The user can then manipulate the delivery system to direct the distal end of the delivery system to the appropriate site. Additionally, the user can further manipulate and control the position of the delivery system by applying torque to the entire delivery system. In the fully bent configuration, the user can then position the replacement valve in the proper location. This can advantageously enable delivery of a replacement valve to an in vivo implantation site, such as a native tricuspid valve.

[0262] 100 illustrates a schematic diagram of the distal end of the delivery system approaching the native tricuspid valve. The distal end of the delivery system may be positioned as desired relative to the implantation site prior to releasing the implant from the implant holding region.

[0263] 101 illustrates that the implant can 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 leaflet can be determined, and if in the proper position, the implantation procedure can proceed.

[0264] 102 illustrates the implant in an expanded configuration, with the tether assembly 662 coupled to the implant. The position of the anchor relative to the native leaflet may be determined, and if in the proper position, the implantation procedure may proceed.

[0265] The tether assembly 662 may be released from the implant using the release of the release assembly. Figure 103 illustrates the release of the tether assembly 662. Figure 104 illustrates the implant deployed in place.

[0266] A similar deployment procedure may be utilized with respect to the mitral valve, if desired. For example, a transseptal puncture may be performed from the right atrium 706 (shown in FIG. 99) to gain access to the left atrium 708. The user may pass a curved delivery system through the transseptal puncture and into the left atrium 708. The delivery system may then be advanced into the left atrium 708 and toward the left ventricle 710. The implant may be deployed in a manner similar to that shown in FIGS. 99-104.

[0267] Each delivery system disclosed herein may be utilized with any of the examples disclosed herein.

[0268] Various modifications of the examples disclosed herein may be provided. Features in the examples may be modified, substituted, omitted, or combined between the examples as desired. Combinations of features between the examples may be provided as desired. Combinations of features may be provided between the examples, if desired, at the exclusion of other features in such examples.

[0269] The various examples of seal skirts disclosed herein may have a variety of configurations, including fabric skirts, foam skirts, or braided skirts, as desired. A variety of materials may be utilized, as desired.

[0270] The implants disclosed herein may include prosthetic heart valves or other forms of implants, such as stents or filters, diagnostic devices, among others. The implants may be expandable implants configured to transition from a compressed or undeployed state to an expanded or deployed state. The implants may be compressible implants configured to be compressed inward to have a reduced outer profile, transitioning the implant to the compressed or undeployed state.

[0271] Various forms of delivery devices may be utilized with the examples disclosed herein. The delivery devices disclosed herein may be utilized in connection with aortic, mitral, tricuspid, and pulmonary valve replacement and repair. Delivery devices may include delivery devices for delivering other forms of implants, such as stents or filters, or diagnostic devices, among others.

[0272] The implants and systems disclosed herein may be used in transcatheter mitral or tricuspid valve implantation, and in transaortic valve implantation (TAVI) or replacement of other native heart valves (e.g., pulmonary valves). The delivery devices and systems disclosed herein may be utilized for transarterial access, including transfemoral access, to a patient's heart. The delivery devices and systems may be utilized in transcatheter and percutaneous procedures, including transarterial procedures that may also be transfemoral. Transapical procedures, among others, may also be utilized. Other procedures may be utilized as desired.

[0273] Additionally, the methods herein are not limited to the specifically described methods, but may include methods for utilizing the systems and devices disclosed herein. Steps in the methods may be modified, omitted, or added depending on the systems, devices, and methods disclosed herein. Examples disclosed herein may, in some instances, include systems for implantation within the human body.

[0274] For purposes of this specification, specific aspects, advantages, and novel features of each example of the disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any manner. Instead, the present disclosure covers all novel and non-obvious features and aspects of the various disclosed examples, in various combinations and subcombinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature, or combination thereof, nor do the disclosed examples require that any one or more particular advantages be present or that any one or more problems be solved be present. Features, elements, or combinations of any example can be combined with other examples herein. [Example]

[0275] Example 1: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve including one or more prosthetic valve leaflets and a valve body supporting the one or more prosthetic valve leaflets, at least a portion of the prosthetic valve including a material configured to reduce tissue or thrombus formation along a portion of the prosthetic valve.

[0276] Example 2: 10. The prosthetic valve of any example herein, particularly example 1, wherein a portion of the prosthetic valve comprises a skirt.

[0277] Example 3: 10. The prosthetic valve according to any embodiment herein, particularly as described in embodiment 2, wherein the prosthetic valve comprises a frame, and wherein the skirt is positioned on the frame.

[0278] Example 4: An artificial valve as described in any example herein, particularly any one of Examples 1-3, wherein one or more artificial valve leaflets are positioned within a flow channel of the artificial valve, the artificial valve including a valve body having an outer surface facing away from the flow channel and an inner surface facing the flow channel, and a portion of the artificial valve includes the inner surface of the valve body.

[0279] Example 5: The prosthetic valve of any example herein, particularly example 4, wherein the outer surface of the valve body is configured for tissue formation or thrombus formation against the outer surface of the valve body.

[0280] Example 6: The prosthetic valve of any example herein, particularly example 4 or example 5, wherein the outer surface includes an end portion, the inner surface includes an end portion proximate the end portion of the outer surface, and a portion of the prosthetic valve includes the end portion of the inner surface.

[0281] Example 7: The prosthetic valve as described in any example herein, particularly as described in Example 6, wherein an end portion of the inner surface is bonded to an end portion of the outer surface.

[0282] Example 8: The prosthetic valve of any example herein, particularly any one of Examples 1-7, wherein the portion of the prosthetic valve comprises a barrier layer adjacent to one or more prosthetic valve leaflets.

[0283] Example 9: The prosthetic valve described in any example herein, particularly Example 8, wherein the barrier layer is configured to reduce the spread of tissue or thrombus formation to one or more prosthetic valve leaflets.

[0284] Example 10: The prosthetic valve according to any example herein, particularly Example 8 or Example 9, wherein one or more prosthetic valve leaflets are bonded to a barrier layer.

[0285] Example 11: An artificial valve as described in any example herein, particularly any one of Examples 1 to 10, wherein the artificial valve has a proximal end portion and a distal end portion, the proximal end portion being located at an inflow point of the artificial valve and the distal end portion being located at an outflow point of the artificial valve, and a portion of the artificial valve is positioned at the proximal end portion of the artificial valve.

[0286] Example 12: 10. The prosthetic valve of any embodiment herein, particularly embodiment 11, wherein a portion of the prosthetic valve includes a skirt extending distally from a proximal rim of the prosthetic valve.

[0287] Example 13: An artificial valve as described in any example herein, particularly any one of Examples 1-12, wherein one or more artificial valve leaflets are positioned within a flow channel of the artificial valve, and a portion of the artificial valve surrounds the flow channel.

[0288] Example 14: The prosthetic valve as described in any example herein, particularly example 13, wherein a portion of the prosthetic valve includes a sleeve surrounding the flow channel.

[0289] Example 15: The prosthetic valve according to any of the examples herein, particularly any one of Examples 1-14, wherein the prosthetic valve is configured to be deployed relative to a native mitral valve or relative to a native tricuspid valve.

[0290] Example 16: 1. A method comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve comprising one or more prosthetic leaflets and a valve body supporting the one or more prosthetic leaflets, at least a portion of the prosthetic valve comprising a material configured to reduce tissue or thrombus formation along a portion of the prosthetic valve.

[0291] Example 17: The method of any example herein, particularly example 16, wherein one or more prosthetic valve leaflets are positioned within a flow channel of the prosthetic valve, the prosthetic valve including a valve body having an outer surface facing away from the flow channel and an inner surface facing the flow channel, and a portion of the prosthetic valve includes the inner surface of the valve body.

[0292] Example 18: The method of any example herein, particularly example 17, wherein the outer surface includes an end portion, the inner surface includes an end portion proximate the end portion of the outer surface, and the portion of the prosthetic valve includes the end portion of the inner surface.

[0293] Example 19: The method of any example herein, particularly any one of Examples 16-18, wherein the portion of the prosthetic valve comprises a barrier layer adjacent to one or more prosthetic valve leaflets.

[0294] Example 20: The method of any example herein, particularly Example 19, wherein the barrier layer is configured to reduce the spread of tissue or thrombus formation to one or more prosthetic valve leaflets.

[0295] Example 21: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve including one or more prosthetic valve leaflets and a valve body supporting the one or more prosthetic valve leaflets, at least a portion of the prosthetic valve including a frame having a roughened surface.

[0296] Example 22: The prosthetic valve as described in any example herein, particularly as described in Example 21, wherein the roughened surface comprises a non-abrasive surface that forms the surface roughness.

[0297] Example 23: The prosthetic valve according to any embodiment herein, particularly according to embodiment 22, wherein the portion of the frame adjacent to the rough surface is smooth.

[0298] Example 24: The prosthetic valve of any example herein, particularly example 23, wherein the portion of the frame adjacent the roughened surface comprises a polished surface.

[0299] Example 25: The prosthetic valve according to any of the examples herein, particularly any one of Examples 21-24, wherein the roughened surface comprises residues from the frame formation process.

[0300] Example 26: The prosthetic valve according to any embodiment herein, particularly any one of embodiments 21 to 25, wherein the frame comprises a shape memory material.

[0301] Example 27: The prosthetic valve according to any embodiment herein, particularly any one of embodiments 21-26, wherein the frame comprises nitinol.

[0302] Example 28: The prosthetic valve as described in any example herein, particularly as described in Example 27, wherein the roughened surface comprises a non-abrasive surface roughness comprised of nitinol.

[0303] Example 29: The prosthetic valve according to any example herein, particularly according to any one of Examples 21 to 28, wherein the roughened surface comprises a microstructure.

[0304] Example 30: The prosthetic valve according to any example herein, particularly any one of Examples 21-29, wherein the roughened surface comprises one or more voids within the surface of the frame.

[0305] Example 31: The prosthetic valve according to any embodiment herein, particularly any one of embodiments 21-30, wherein the roughened surface is configured to provide friction against a portion of the native valve.

[0306] Example 32: The prosthetic valve according to any of the examples herein, particularly any one of Examples 21-31, wherein the roughened surface is configured for tissue formation against the frame.

[0307] Example 33: The prosthetic valve according to any embodiment herein, particularly any one of embodiments 21-32, wherein the frame comprises a portion of the sealing body for forming a seal against the native valve.

[0308] Example 34: The prosthetic valve according to any embodiment herein, particularly any one of embodiments 21 to 33, wherein the frame comprises one or more anchors having a roughened surface.

[0309] Example 35: The prosthetic valve according to any embodiment herein, particularly any one of embodiments 21 to 34, wherein the prosthetic valve is configured to be deployed relative to a native mitral valve or relative to a native tricuspid valve.

[0310] Example 36: 1. A method comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve including one or more prosthetic leaflets and a valve body supporting the one or more prosthetic leaflets, at least a portion of the prosthetic valve including a frame having a roughened surface.

[0311] Example 37: The method of any example herein, particularly example 36, wherein the roughened surface comprises a non-abrasive surface that forms the surface roughness.

[0312] Example 38: The method of any example herein, particularly Example 36 or Example 37, wherein the roughened surface comprises residue from the frame formation process.

[0313] Example 39: The method of any embodiment herein, particularly any one of embodiments 36-38, wherein the frame comprises nitinol.

[0314] Example 40: The method of any example herein, particularly example 39, wherein the roughened surface comprises a non-abrasive surface roughness comprised of nitinol.

[0315] Example 41: 1. A prosthetic valve configured to be deployed relative to a native valve having native leaflets, the prosthetic valve comprising: one or more prosthetic leaflets; a valve body supporting the one or more prosthetic leaflets, the valve body including one or more grasping features configured to be positioned radially inward of the one or more native leaflets; and one or more anchors configured to be positioned radially outward of one or more of the native leaflets, the anchors configured to press one or more of the native leaflets toward the one or more grasping features, thereby reducing movement of the one or more native leaflets relative to the valve body.

[0316] Example 42: A prosthetic valve as described in any example herein, particularly as described in example 41, wherein one or more gripping features are positioned on the seal body for forming a seal against the native valve.

[0317] Example 43: The prosthetic valve as described in any example herein, particularly as described in example 41 or example 42, wherein the one or more gripping features are positioned on a frame of the valve body.

[0318] Example 44: A prosthetic valve as described in any example herein, particularly any one of Examples 41-43, wherein the one or more gripping features are configured to reduce axial movement of one or more of the native valve leaflets relative to the valve body.

[0319] Example 45: The prosthetic valve of any embodiment herein, particularly any one of embodiments 41-44, wherein the one or more gripping features comprise a surface roughness of the frame.

[0320] Example 46: The prosthetic valve of any embodiment herein, particularly any one of embodiments 41-45, wherein the one or more gripping features include one or more protrusions.

[0321] Example 47: The prosthetic valve according to any embodiment herein, particularly embodiment 46, wherein the one or more protrusions extend from the frame of the valve body.

[0322] Example 48: The prosthetic valve according to any example herein, particularly example 46 or example 47, wherein the one or more protrusions extend distally.

[0323] Example 49: An artificial valve as described in any example herein, particularly any one of Examples 41 to 48, 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, thereby deflecting one or more of the native valve leaflets between the one or more grasping features and the one or more anchors.

[0324] Example 50: An artificial valve as described in any embodiment herein, particularly any one of embodiments 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 toward one or more grasping features.

[0325] Example 51: A prosthetic valve as described in any embodiment herein, particularly as described in embodiment 50, wherein the tip includes a recess configured to receive one or more gripping features.

[0326] Example 52: An artificial valve as described in any embodiment herein, particularly any one of embodiments 41 to 51, wherein the valve body includes a frame having a plurality of struts and openings between the plurality of struts, and each of the one or more anchors is configured to be circumferentially aligned with at least one of the openings.

[0327] Example 53: An artificial valve as described in any example herein, particularly as described in example 52, wherein the one or more gripping features include one or more protrusions extending from the frame toward at least one of the openings.

[0328] Example 54: An artificial valve as described in any embodiment herein, particularly any one of embodiments 41 to 53, wherein the valve body includes a distal end portion and a proximal end portion, and one or more anchors extend from the distal end portion of the valve body.

[0329] Example 55: An artificial valve as described in any embodiment herein, particularly any one of embodiments 41 to 54, wherein one or more anchors are configured to extend onto the distal tip of one of the native valve leaflets.

[0330] Example 56: A prosthetic valve as described in any example herein, particularly any one of Examples 41 to 55, wherein the one or more anchors are configured to be hooked around the native valve leaflets.

[0331] Example 57: An artificial valve as described in any embodiment herein, particularly any one of embodiments 41 to 56, wherein the valve body includes an inner valve body and an outer valve body surrounding the inner valve body, and one or more gripping features are positioned on the outer valve body.

[0332] Example 58: An artificial valve as described in any example herein, particularly any one of examples 41 to 57, wherein the one or more anchors are configured to resist distal movement of the artificial valve by pressing one or more of the native valve leaflets against one or more grasping features.

[0333] Example 59: The prosthetic valve described in any example herein, particularly any one of 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 resist movement of the prosthetic valve toward the ventricle by pressing one or more of the native valve leaflets against one or more grasping features.

[0334] Example 60: A prosthetic valve as described in any example herein, particularly as described in example 59, wherein one or more anchors resist movement of the prosthetic valve toward the atrium by hooking around the native valve leaflets.

[0335] Example 61: An artificial valve as described in any embodiment herein, particularly any one of embodiments 41 to 60, wherein the valve body includes an outer frame and at least one of the plurality of anchors has a tip positioned distally from the outer frame.

[0336] Example 62: An artificial valve as described in any embodiment herein, particularly as described in embodiment 61, wherein the tip of at least one of the multiple anchors protrudes to a radius smaller than the radius of the outer surface of the outer frame.

[0337] Example 63: An artificial valve as described in any example herein, particularly as 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 at least one tip of the plurality of anchors is positioned within one of the openings.

[0338] Example 64: An artificial valve as described in any embodiment herein, particularly as described in embodiment 63, wherein one of the openings is a distal-most opening positioned between adjacent distal-most struts of the plurality of struts.

[0339] Example 65: An artificial valve described in any embodiment of the present specification, particularly any one of embodiments 61 to 64, wherein the valve body includes a skirt, and the skirt is positioned radially inward from the tip of at least one of the plurality of anchors.

[0340] Example 66: 1. A method comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve comprising one or more prosthetic leaflets; a valve body supporting the one or more prosthetic leaflets, the valve body including one or more grasping features configured to be positioned radially inward of the one or more native leaflets; and one or more anchors configured to be positioned radially outward of one or more of the native leaflets, the anchors configured to press the one or more native leaflets against the one or more grasping features, thereby reducing movement of the one or more native leaflets relative to the valve body.

[0341] Example 67: The method of any embodiment herein, particularly embodiment 66, wherein one or more gripping features are positioned on the seal body for forming a seal against the native valve.

[0342] Example 68: A method described in any example herein, particularly example 66 or example 67, wherein the one or more gripping features are configured to reduce axial movement of one or more of the native valve leaflets relative to the valve body.

[0343] Example 69: The method of any embodiment herein, particularly any one of embodiments 66-68, wherein the one or more gripping features comprise a surface roughness of the frame.

[0344] Example 70: The method of any embodiment herein, particularly any one of embodiments 66-69, wherein the one or more gripping features comprise one or more protrusions.

[0345] Example 71: 1. A prosthetic valve configured to be deployed relative to a native valve having native valve leaflets, the prosthetic valve comprising: 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, the one or more anchors configured to be positioned radially outward of the one or more native valve leaflets to capture one or more of the native valve leaflets, at least a portion of the prosthetic valve comprising one or more grasping features configured to engage against a surface of the native valve when an anchor fails to capture one or more of the native valve leaflets.

[0346] Example 72: An artificial valve as described in any embodiment herein, particularly as described in embodiment 71, wherein one or more grasping features are configured to be positioned radially inward of one or more native valve leaflets when one anchor fails to capture one or more native valve leaflets.

[0347] Example 73: A prosthetic valve as described in any example herein, particularly as described in example 71 or example 72, wherein the one or more gripping features are positioned on one or more anchors.

[0348] Example 74: An artificial valve as described in any embodiment herein, particularly as described in embodiment 73, wherein one or more gripping features on one anchor capturing one native valve leaflet are configured to be positioned radially outward of the native valve leaflet being captured.

[0349] Example 75: An artificial valve as described in any example herein, particularly as described in example 73 or example 74, wherein the one or more gripping features are positioned on portions of the one or more anchors configured to face radially outward.

[0350] Example 76: An artificial valve as described in any embodiment herein, particularly as described in embodiment 75, wherein portions of the one or more anchors are configured to face radially outward when the one or more anchors are deployed and configured to face radially inward when the one or more anchors are not deployed.

[0351] Example 77: A prosthetic valve as described in any embodiment herein, particularly any one of embodiments 71-76, wherein one or more gripping features are positioned on the valve body.

[0352] Example 78: A prosthetic valve as described in any example herein, particularly as described in example 77, wherein the one or more gripping features are configured to extend radially outward from the valve body.

[0353] Example 79: An artificial valve as described in any example herein, particularly as described in example 77 or example 78, wherein one or more gripping features are configured to protrude radially outward from the valve body to a greater radial distance than one or more anchors.

[0354] Example 80: An artificial valve as described in any embodiment herein, particularly any one of embodiments 71 to 79, wherein the one or more gripping features include one or more protrusions configured to extend distally.

[0355] Example 81: The prosthetic valve of any embodiment herein, particularly any one of embodiments 71-80, wherein the one or more gripping features include one or more barbs.

[0356] Example 82: An artificial valve as described in any embodiment herein, particularly any one of embodiments 71 to 81, wherein one or more gripping features are configured to have greater resistance to force in a proximal direction than in a distal direction.

[0357] Example 83: A prosthetic valve as described in any embodiment herein, particularly any one of embodiments 71-82, wherein the anchor that fails to capture one or more native valve leaflets is configured to be positioned radially inward of the one or more native valve leaflets.

[0358] Example 84: The prosthetic valve according to any embodiment herein, particularly any one of embodiments 71 to 83, wherein the valve body includes a frame.

[0359] Example 85: The prosthetic valve according to any embodiment herein, particularly any one of embodiments 71 to 84, wherein the valve body comprises an inner valve body and an outer valve body.

[0360] Example 86: The prosthetic valve according to any embodiment herein, particularly embodiment 85, wherein the outer valve body comprises a frame and a skirt covering the frame.

[0361] Example 87: An artificial valve as described in any embodiment herein, particularly any one of embodiments 71 to 86, wherein the valve body includes a distal end portion and a proximal end portion, and one or more anchors extend from the distal end portion of the valve body.

[0362] Example 88: An artificial valve as described in any embodiment herein, particularly any one of embodiments 71 to 87, wherein one or more anchors are configured to extend onto the distal tip of one of the native valve leaflets.

[0363] Example 89: An artificial valve as described in any example herein, particularly any one of examples 71 to 88, wherein one or more anchors are configured to be hooked around the native valve leaflets.

[0364] Example 90: The prosthetic valve described in any example herein, particularly any one of Examples 71 to 89, wherein the prosthetic valve is configured to be deployed relative to a native mitral valve or relative to a native tricuspid valve.

[0365] Example 91: 1. A method comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve comprising one or more prosthetic leaflets, a valve body supporting the one or more prosthetic leaflets, and one or more anchors extending from the valve body, the one or more anchors configured to be positioned radially outward of the one or more native valve leaflets to capture one or more of the native valve leaflets, at least a portion of the prosthetic valve comprising one or more grasping features configured to engage against a surface of the native valve when an anchor fails to capture one or more of the native valve leaflets.

[0366] Example 92: A method as described in any embodiment herein, particularly as described in embodiment 91, wherein the one or more grasping features are configured to be positioned radially inward of one or more native valve leaflets when one anchor fails to capture one or more native valve leaflets.

[0367] Example 93: The method of any example herein, particularly example 91 or example 92, wherein the one or more gripping features are positioned on one or more anchors.

[0368] Example 94: The method of any embodiment herein, particularly any one of embodiments 91-93, wherein the one or more gripping features are positioned on the valve body.

[0369] Example 95: The method described in any embodiment herein, particularly embodiment 94, wherein the one or more gripping features are configured to extend radially outward from the valve body.

[0370] Example 96: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve including: one or more prosthetic valve leaflets; and a valve body supporting the one or more prosthetic valve leaflets, the valve body having an outer surface, the outer surface of the valve body including a channel for passing a pacemaker lead.

[0371] Example 97: The prosthetic valve according to any embodiment herein, particularly embodiment 96, wherein the outer surface of the valve body is configured to contact the native valve.

[0372] Example 98: A prosthetic valve as described in any example herein, particularly as described in example 96 or example 97, wherein the outer surface of the valve body includes a sealing surface configured to form a seal against the native valve.

[0373] Example 99: The prosthetic valve according to any embodiment herein, particularly any one of embodiments 96-98, wherein the channel comprises a recess in the outer surface of the valve body.

[0374] Example 100: An artificial valve as described in any embodiment herein, particularly any one of embodiments 96-99, wherein the valve body includes a frame having a plurality of struts and openings between the plurality of struts, and the channel extends through at least one of the openings.

[0375] Example 101: The prosthetic valve according to any embodiment herein, particularly embodiment 100, wherein the channel extends between at least two struts.

[0376] Example 102: The prosthetic valve according to any embodiment herein, particularly any one of embodiments 96 to 101, wherein the valve body comprises a skirt and the channel comprises a recess in the skirt.

[0377] Example 103: An artificial valve as described in any embodiment of the present specification, particularly any one of embodiments 96 to 102, further comprising a plurality of anchors for anchoring the valve body to the native valve, wherein the channel is positioned circumferentially between two of the plurality of anchors.

[0378] Example 104: A prosthetic valve as described in any embodiment herein, particularly as described in embodiment 103, wherein the channel is configured to be positioned between the outer surface of the valve body and the inner surface of the native valve.

[0379] Example 105: The prosthetic valve described in any embodiment herein, particularly any one of embodiments 96 to 104, wherein the prosthetic valve is configured to be deployed relative to a native mitral valve or relative to a native tricuspid valve.

[0380] Example 106: 1. A method comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve comprising one or more prosthetic leaflets and a valve body supporting the one or more prosthetic leaflets, the valve body having an outer surface, the outer surface of the valve body comprising a channel for passing a pacemaker lead.

[0381] Example 107: The method of any embodiment herein, particularly embodiment 106, wherein the outer surface of the valve body is configured to contact the native valve.

[0382] Example 108: The method of any embodiment herein, particularly embodiment 106 or embodiment 107, wherein the outer surface of the valve body comprises a sealing surface configured to form a seal against the native valve.

[0383] Example 109: The method of any embodiment herein, particularly any one of embodiments 106-108, wherein the channel comprises a recess in the outer surface of the valve body.

[0384] Example 110: The method of any embodiment herein, particularly any one of embodiments 106-109, wherein the valve body includes a frame having a plurality of struts and openings between the plurality of struts, and the channel extends through at least one of the openings.

[0385] Example 111: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve comprising: an inner frame supporting one or more prosthetic valve leaflets; a valve body including: an inner frame, the inner frame being a valve body and supporting the one or more prosthetic valve leaflets, the inner frame having a proximal end portion and a distal end portion; an outer frame positioned radially outward from the inner frame, the outer frame having a proximal end portion and a distal end portion and an outer surface facing radially outward from the prosthetic valve, the proximal end portion of the outer frame being coupled to the proximal end portion of the inner frame and the distal end portion of the outer frame being spaced apart from the inner frame by a gap; and a plurality of anchors each coupled to the inner frame, the plurality of anchors having a hook shape and extending radially outward from the inner frame, wherein a first anchor of the plurality of anchors has a tip positioned radially outward from the outer frame and has a tip that overlaps with the outer surface, and a second anchor of the plurality of anchors has a tip positioned distal to the outer frame and has a tip that is at least partially recessed radially inward from the outer surface.

[0386] Example 112: An artificial valve as described in any embodiment herein, particularly as described in embodiment 111, wherein the tip of a second anchor of the plurality of anchors protrudes to a radius smaller than the radius of the outer surface of the outer frame.

[0387] Example 113: An artificial valve as described in any example herein, particularly as described in example 111 or example 112, wherein the outer frame includes a plurality of struts, openings are formed between the plurality of struts, and a tip of a second anchor of the plurality of anchors is positioned within one of the openings.

[0388] Example 114: An artificial valve as described in any embodiment herein, particularly as described in embodiment 113, wherein one opening is a distal-most opening positioned between adjacent distal-most struts of the plurality of struts.

[0389] Example 115: An artificial valve as described in any embodiment herein, particularly any one of embodiments 111 to 114, wherein the tip of a second anchor of the plurality of anchors extends to a lower axial height in the proximal direction of the artificial valve compared to the tip of a first anchor of the plurality of anchors.

[0390] Example 116: An artificial valve as described in any embodiment herein, particularly any one of embodiments 111 to 115, wherein each of the plurality of anchors includes a drop loop, and the drop loop of a second anchor of the plurality of anchors protrudes axially distally of the artificial valve relative to the position of the drop loop of a first anchor of the plurality of anchors.

[0391] Example 117: An artificial valve described in any embodiment of the present specification, particularly any one of embodiments 111 to 116, wherein the valve body includes a skirt, and the skirt is positioned radially inward from the tip of the second anchor of the plurality of anchors.

[0392] Example 118: An artificial valve as described in any embodiment of the present specification, particularly any one of embodiments 111 to 117, wherein the outer frame includes one or more gripping features configured to be positioned radially inward of one or more leaflets of the native valve, and the tip of a first anchor of the plurality of anchors overlaps the one or more gripping features, thereby pressing the one or more leaflets of the native valve toward the one or more gripping features, thereby reducing movement of the one or more leaflets of the native valve relative to the valve body.

[0393] Example 119: An artificial valve described in any embodiment of the present specification, particularly any one of embodiments 111 to 118, wherein the plurality of anchors includes at least three anchors each having a tip positioned radially outward from the outer frame and overlapping the outer surface, and the plurality of anchors includes at least two anchors each having a tip positioned distally from the outer frame.

[0394] Example 120: An artificial valve described in any embodiment of the present specification, particularly any one of embodiments 111 to 119, wherein the plurality of anchors includes at least four anchors each having a tip positioned radially outward from the outer frame and overlapping the outer surface, and the plurality of anchors includes at least three anchors each having a tip positioned distally from the outer frame.

[0395] Example 121: An artificial valve as described in any example herein, particularly any one of examples 111-120, wherein a first portion of the circumference of the artificial valve includes a plurality of anchors, each having a tip positioned radially outward from the outer frame and overlapping the outer surface, and a second portion of the circumference includes a plurality of anchors, each having a tip positioned distally from the outer frame, and the first portion includes at least 180 degrees of the circumference.

[0396] Example 122: The prosthetic valve as described in any embodiment herein, particularly embodiment 121, wherein the first portion comprises at least 200 degrees of the circumference.

[0397] Example 123: An artificial valve as described in any embodiment herein, particularly as described in any one of embodiments 111 to 122, wherein the outer frame has an elliptical outer profile.

[0398] Example 124: An artificial valve as described in any embodiment of the present specification, particularly any one of embodiments 111 to 123, wherein each of the plurality of anchors is adapted to anchor to the native valve by hooking onto the native valve leaflets.

[0399] Example 125: The prosthetic valve as described in any example herein, particularly any one of Examples 111-124, wherein the prosthetic valve comprises a prosthetic mitral valve or a prosthetic tricuspid valve.

[0400] Example 126: A method includes deploying a prosthetic valve relative to a native valve, the prosthetic valve including one or more prosthetic leaflets, a valve body, an inner frame supporting the one or more prosthetic leaflets, the inner frame having a proximal end portion and a distal end portion, and an outer frame positioned radially outward from the inner frame, the outer frame having a proximal end portion, a distal end portion, and an outer surface facing radially outward from the prosthetic valve, the proximal end portion of the outer frame being coupled to the proximal end portion of the inner frame, and the distal end portion of the outer frame being spaced apart from the inner frame by a gap. and a plurality of anchors each coupled to the inner frame, the anchors 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 outward from the outer frame and overlapping the outer surface, and a second anchor of the plurality of anchors having a tip positioned distally from the outer frame and at least partially recessed radially inward from the outer surface.

[0401] Example 127: A method described in any example herein, particularly example 126, wherein the tip of a second anchor of the plurality of anchors protrudes to a radius smaller than the radius of the outer surface of the outer frame.

[0402] Example 128: The method of any embodiment herein, particularly embodiment 126 or embodiment 127, wherein the outer frame includes a plurality of struts having openings formed between the struts, and a tip of a second anchor of the plurality of anchors is positioned within one of the openings.

[0403] Example 129: The method described in any embodiment herein, particularly embodiment 128, wherein one opening is a distal-most opening positioned between adjacent distal-most struts of the plurality of struts.

[0404] Example 130: The method of any embodiment herein, particularly any one of embodiments 126-129, wherein a tip of a second anchor of the plurality of anchors extends to a lower axial height in a proximal direction of the prosthetic valve compared to a tip of a first anchor of the plurality of anchors.

[0405] Example 131: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; a valve body supporting the one or more prosthetic valve leaflets; one or more hook arm anchors coupled to the valve body, each adapted to anchor to the native valve by hooking onto a leaflet of the native valve; and one or more clasp anchors coupled to the valve body, each adapted to anchor to the native valve by clamping a portion of the native valve.

[0406] Example 132: An artificial valve as described in any embodiment herein, particularly as described in embodiment 131, wherein the valve body includes an outer surface facing radially outward, and each of the one or more hook arm anchors protrudes radially outward from the outer surface of the valve body.

[0407] Example 133: An artificial valve as described in any embodiment herein, particularly as described in embodiment 131 or embodiment 132, wherein the valve body includes an outer surface facing radially outward, and one or more clasp anchors are flush with the outer surface of the valve body.

[0408] Example 134: An artificial valve described in any embodiment of the present specification, particularly any one of embodiments 131 to 133, wherein each of the one or more clasp anchors has a tip having a circumferentially planar shape.

[0409] Example 135: An artificial valve as described in any embodiment herein, particularly any one of embodiments 131 to 134, wherein each of the one or more clasp anchors has a drop loop and is spring-biased toward the valve body.

[0410] Example 136: An artificial valve as described in any embodiment herein, particularly any one of embodiments 131 to 135, wherein the valve body includes an outer surface facing radially outward, and each of the one or more clasp anchors is adapted to clamp a portion of the leaflet of the native valve against the outer surface of the valve body.

[0411] Example 137: An artificial valve as described in any example herein, particularly any one of examples 131 to 136, wherein the valve body includes an inner frame supporting one or more artificial valve leaflets, the inner frame having a proximal end portion and a distal end portion, and an outer frame positioned radially outward from the inner frame, the outer frame having a proximal end portion, a distal end portion, and an outer surface facing radially outward from the artificial valve, the proximal end portion of the outer frame being coupled to the proximal end portion of the inner frame and the distal end portion of the outer frame being spaced apart from the inner frame by a gap, and wherein one or more clasp anchors are coupled to the distal end portion of the inner frame.

[0412] Example 138: An artificial valve as described in any example herein, particularly any one of examples 131 to 137, wherein the valve body includes an inner frame supporting one or more artificial valve leaflets, the inner frame having a proximal end portion and a distal end portion, and an outer frame positioned radially outward from the inner frame, the outer frame having a proximal end portion, a distal end portion and an outer surface facing radially outward from the artificial valve, the proximal end portion of the outer frame being coupled to the proximal end portion of the inner frame and the distal end portion of the outer frame being spaced apart from the inner frame by a gap, and wherein one or more clasp anchors are coupled to the distal end portion of the outer frame.

[0413] Example 139: An artificial valve as described in any embodiment herein, particularly any one of embodiments 131 to 138, wherein the valve body includes one or more gripping features configured to be positioned radially inward of one or more leaflets of a native valve.

[0414] Example 140: An artificial valve as described in any embodiment herein, particularly as described in embodiment 139, wherein one or more clasp anchors overlap one or more grasping features, thereby pressing one or more leaflets of the native valve toward the one or more grasping features, thereby reducing movement of one or more leaflets of the native valve relative to the valve body.

[0415] Example 141: An artificial valve as described in any example herein, particularly as described in example 139 or example 140, wherein one or more hook arm anchors overlap one or more grasping features, thereby pressing one or more leaflets of the native valve toward the one or more grasping features, thereby reducing movement of one or more leaflets of the native valve relative to the valve body.

[0416] Example 142: The prosthetic valve according to any embodiment herein, particularly any one of embodiments 131 to 141, wherein the one or more clasp anchors include at least two clasp anchors.

[0417] Example 143: An artificial valve as described in any example herein, particularly any one of Examples 131-142, wherein a first portion of the circumference of the artificial valve comprises one or more hook arm anchors and a second portion of the circumference comprises one or more clasp anchors, and the first portion comprises at least 180 degrees of the circumference.

[0418] Example 144: The prosthetic valve as described in any embodiment herein, particularly embodiment 143, wherein the first portion comprises at least 200 degrees of the circumference.

[0419] Example 145: The prosthetic valve as described in any example herein, particularly any one of Examples 131-144, wherein the prosthetic valve comprises a prosthetic mitral valve or a prosthetic tricuspid valve.

[0420] Example 146: 1. A method comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve including one or more prosthetic leaflets, a valve body supporting the one or more prosthetic leaflets, one or more hook arm anchors coupled to the valve body, each adapted to anchor to the native valve by hooking onto a leaflet of the native valve, and one or more clasp anchors coupled to the valve body, each adapted to anchor to the native valve by clamping a portion of the native valve.

[0421] Example 147: The method of any embodiment herein, particularly embodiment 146, wherein the valve body includes an outer surface facing radially outward, and each of the one or more hook arm anchors protrudes radially outward from the outer surface of the valve body.

[0422] Example 148: The method of any embodiment herein, particularly embodiment 146 or embodiment 147, wherein the valve body includes an outer surface facing radially outward, and the one or more clasp anchors are flush with the outer surface of the valve body.

[0423] Example 149: A method described in any embodiment herein, particularly any one of embodiments 146 to 148, wherein each of the one or more clasp anchors has a tip having a circumferentially planar shape.

[0424] Example 150: A method described in any embodiment herein, particularly any one of embodiments 146 to 149, wherein each of the one or more clasp anchors has a drop loop and is spring-biased toward the valve body.

[0425] Example 151: 1. A prosthetic valve configured to be deployed relative to a native valve between an atrium and a ventricle, the prosthetic valve comprising: one or more prosthetic valve leaflets; a valve body supporting the one or more prosthetic valve leaflets, the valve body having a proximal end portion and a distal end portion; one or more hook arm anchors coupled to the valve body, each adapted to anchor to the native valve by hooking onto a leaflet of the native valve; and one or more support arms coupled to the valve body, each having a proximal end portion coupled to the valve body and a distal end portion protruding distally from the valve body and configured to extend into the ventricle, the one or more support arms further adapted to stabilize the prosthetic valve within the native valve.

[0426] Example 152: The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 151, wherein the one or more support arms include at least two support arms.

[0427] Example 153: An artificial valve as described in any embodiment herein, particularly as described in embodiment 151 or embodiment 152, wherein one or more support arms extend axially distally to the tip of each corresponding support arm.

[0428] Example 154: An artificial valve as described in any embodiment of the present specification, particularly any one of embodiments 151 to 153, wherein the valve body includes an inner frame supporting one or more artificial valve leaflets, the inner frame having a proximal end portion and a distal end portion, and an outer frame positioned radially outward from the inner frame, the outer frame having a proximal end portion and a distal end portion, wherein the proximal end portion of the outer frame is joined to the proximal end portion of the inner frame and the distal end portion of the outer frame is spaced apart from the inner frame by a gap.

[0429] Example 155: A prosthetic valve as described in any embodiment herein, particularly as described in embodiment 154, wherein the one or more support arms are coupled to a distal end portion of the inner frame.

[0430] Example 156: A prosthetic valve as described in any example herein, particularly as described in example 154 or example 155, wherein one or more hook arm anchors are coupled to a distal end portion of the inner frame.

[0431] Example 157: An artificial valve as described in any embodiment herein, particularly any one of embodiments 151 to 156, wherein one or more hook arm anchors are positioned on a first portion of the valve body extending over at least 180 degrees around the circumference of the artificial valve, and one or more support arms are positioned on a second portion of the valve body opposite the first portion.

[0432] Example 158: The prosthetic valve of any embodiment herein, particularly embodiment 157, wherein the first portion of the valve body extends around at least 200 degrees of the circumference.

[0433] Example 159: A prosthetic valve as described in any example herein, particularly as described in example 157 or example 158, wherein the second portion of the valve body does not have a hook arm anchor.

[0434] Example 160: The artificial valve is a prosthetic tricuspid valve, and the second part is adapted to face the septal side of the native tricuspid valve, as described in any example herein, particularly any one of examples 157 to 159.

[0435] Example 161: An artificial valve as described in any embodiment herein, particularly any one of embodiments 157 to 160, wherein the second portion of the valve body has an outer surface facing radially outward and includes a friction element for providing friction against the native valve.

[0436] Example 162: An artificial valve as described in any embodiment herein, particularly as described in embodiment 161, wherein the friction element includes barbs extending parallel to the plane of the outer surface of the valve body.

[0437] Example 163: The prosthetic valve as described in any example herein, particularly as described in example 161 or example 162, wherein the friction element comprises a barbed sheet.

[0438] Example 164: The prosthetic valve as described in any embodiment herein, particularly embodiment 163, wherein the return sheet includes arms surrounding one or more openings.

[0439] Example 165: An artificial valve as described in any example herein, particularly any one of examples 151 to 164, wherein the one or more support arms are adapted to stabilize the artificial valve within the native valve by contacting the inner heart wall within the ventricle, and the one or more support arms include puncturing elements for fixing the one or more support arms to the heart wall by puncturing the heart wall of the ventricle.

[0440] Example 166: 1. A method comprising deploying a prosthetic valve relative to a native valve, the prosthetic valve including one or more prosthetic leaflets and a valve body supporting the one or more prosthetic leaflets, the valve body having a proximal end portion and a distal end portion; one or more hook arm anchors coupled to the valve body, each adapted to anchor to the native valve by hooking onto the leaflets of the native valve; and one or more support arms coupled to the valve body, each having a proximal end portion coupled to the valve body and a distal end portion protruding distally from the valve body and configured to extend into a ventricle, the one or more support arms further adapted to stabilize the prosthetic valve within the native valve.

[0441] Example 167: The method of any embodiment herein, particularly embodiment 166, wherein the one or more support arms comprises at least two support arms.

[0442] Example 168: A method described in any embodiment herein, particularly embodiment 166 or embodiment 167, wherein one or more support arms extend axially distally to the tip of each corresponding support arm.

[0443] Example 169: The method of any embodiment herein, particularly any one of embodiments 166-168, wherein the valve body comprises an inner frame supporting one or more prosthetic valve leaflets, the inner frame having a proximal end portion and a distal end portion, and an outer frame positioned radially outward from the inner frame, the outer frame having a proximal end portion and a distal end portion, wherein the proximal end portion of the outer frame is bonded to the proximal end portion of the inner frame and the distal end portion of the outer frame is spaced apart from the inner frame by a gap.

[0444] Example 170: The method described in any embodiment herein, particularly embodiment 169, wherein the one or more support arms are coupled to a distal end portion of the inner frame.

[0445] Any feature in any of the above-mentioned embodiments, including but not limited to, any of Examples 1 to 170, can be applied to all other aspects and embodiments specified herein, including but not limited to, any of Examples 1 to 170. Furthermore, any feature in one embodiment of various embodiments, including but not limited to, any of Examples 1 to 170, can be independently combined, partially or entirely, in any manner, with other embodiments described herein. For example, one, two, three, or more embodiments may be combined, partially or partially. Furthermore, any feature in various embodiments, including but not limited to, any of Examples 1 to 170, can be optional with respect to other embodiments. Any embodiment related to a method can be performed by a system or device of another embodiment, and any aspect or embodiment of a system or device can be configured to perform the method of another embodiment or embodiment, including but not limited to, any of Examples 1 to 170.

[0446] In summary, although aspects of the present specification have been emphasized by reference to specific examples, it will be understood that 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 will be understood that the disclosed subject matter is not limited in any way to the specific methodology, protocols, and / or reagents, etc., described herein. Therefore, various modifications or variations on the disclosed subject matter or alternative configurations can be made in accordance with the teachings herein without departing from the spirit of the specification. Finally, the terminology used herein is for the purpose of describing particular examples only and is not intended to limit the scope of the systems, devices, and methods disclosed herein, the scope of which is defined solely by the claims. Therefore, the systems, devices, and methods are not limited strictly to those shown and described.

[0447] Certain examples of systems, devices, and methods are described herein, including the best modes known to the inventors for carrying out the same. Of course, variations on these described examples will be apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors anticipate that skilled artisans will adopt such variations as appropriate, 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. Moreover, unless otherwise indicated herein or clearly contradicted by context, all combinations of the above-described examples in all possible variations thereof are encompassed by the systems, devices, and methods.

[0448] Groupings of alternative examples, elements, or steps in systems, apparatus, and methods are not to be construed as limiting. Members of each group may be referenced and claimed individually or in any combination with members of other groups as disclosed herein. It is contemplated that one or more members of a group may be included within, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion is made, the specification is deemed to include the modified group, and thus fulfills the recitation of all Markush groups used in the appended claims.

[0449] Unless otherwise indicated, all numbers expressing features, items, quantities, parameters, characteristics, terms, and the like used in the specification and claims are to be understood in all instances as being modified by the term "about." As used herein, the term "about" is meant to encompass approximations that may vary, but may still perform the desired operation or process described herein, so long as the feature, item, quantity, parameter, characteristic, or term so qualified is used.

[0450] When used in the context of describing systems, devices, and methods (particularly in the context of the claims that follow), the terms "a," "an," "the," and similar reference words should be construed to cover both the singular and the plural unless otherwise indicated herein or clearly contradicted by context. All methods described herein can be performed in any suitable order unless otherwise indicated herein or clearly contradicted by context. Any and all examples or exemplary language (e.g., "etc.") as provided herein are intended merely to more clearly illustrate the systems, devices, and methods and do not pose a limitation on the scope of the otherwise claimed systems, devices, and methods. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the systems, devices, and methods.

[0451] All patents, patent publications, and other publications referenced or identified herein are individually and expressly incorporated by reference in their entirety for the purpose of describing and disclosing, for example, the compositions and methodologies described therein that may be used in connection with the systems, apparatus, and methods. These publications are provided only as they are disclosed prior to the filing date of this application. Nothing in this regard should be construed as an admission that the inventors are not entitled to revert to such disclosure by virtue of prior invention or for any other reason. All statements as to the date or contents of these documents are based on the information available to the applicant and do not constitute any admission as to the correctness of the dates or contents of these documents.

Claims

1. 1. A prosthetic heart valve for replacing the function of a native heart valve, comprising: a self-expanding frame sized for deployment within the native heart valve, the frame having an outer surface for pressing against tissue of the native heart valve; a plurality of prosthetic valve leaflets positioned within the frame, the prosthetic valve leaflets configured to allow flow in a first direction and to block flow in a second direction; a fabric skirt covering at least a portion of the outer surface of the frame; a plurality of ventricular anchors extending from a downstream portion of the frame and configured to capture native leaflets of the native heart valve between the anchors and the outer surface of the frame; A prosthetic heart valve, wherein a plurality of barbs are provided along the outer surface of the frame, and the ventricular anchor secures the prosthetic heart valve inside the native heart valve by pressing the native valve leaflets against the barbs.

2. 10. The prosthetic heart valve of 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 native heart valve.

3. 3. The prosthetic heart valve of claim 2, wherein the barbs are disposed on the outer frame and sized to extend through the fabric skirt and into the tissue of the native heart valve.

4. 4. The prosthetic heart valve of claim 2, wherein the inner frame is coupled to the outer frame via an intermediate component to allow movement of the inner frame relative to the outer frame.

5. The prosthetic heart valve of any of claims 2 to 4, wherein the barbs are positioned 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. 7. The prosthetic heart valve according to claim 2, 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 of claim 7, wherein the intermediate portion of the outer frame has a diameter in the range of approximately 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 the outer frame is adapted to adapt to the shape of the native heart valve.

10. 10. The prosthetic heart valve of claim 2, wherein the outer surface of the outer frame includes a plurality of axially extending recesses spaced about the outer surface for receiving a corresponding one of the ventricular anchors.

11. 11. The prosthetic heart valve according to claim 2, wherein the inner frame includes a first frame coupled to a second frame, the first frame including struts and surrounding a flow channel of the prosthetic heart valve, and the second frame includes struts of the plurality of ventricular anchors, and a radial thickness of the struts of the plurality of ventricular anchors is thinner than a radial thickness of the struts of the first frame.

12. The artificial heart valve according to any one of claims 1 to 11, wherein the artificial 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. 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, wherein tension can be applied to the sutures so that the prosthetic heart valve can be retrieved after deployment.

15. The prosthetic heart valve of any one of claims 1 to 14, wherein the self-expanding frame includes a plurality of struts forming expandable and contractible cells, and 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 pressed against the tissue of the native heart valve by being at least partially recessed radially inward from the outer surface of the prosthetic heart valve.

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

18. The prosthetic heart valve of any preceding claim, wherein the ventricular anchors are unevenly spaced apart relative to one another.

19. 19. The prosthetic heart valve of claim 1, wherein the plurality of ventricular anchors include radially inwardly spring-biased clasps.

20. 20. The prosthetic heart valve of claim 19, wherein a first portion of the circumference of the prosthetic heart valve includes the clasp and a second portion of the circumference opposite the first portion includes a hook arm anchor.

21. 21. The prosthetic heart valve of claim 1, further comprising one or more support arms coupled to the frame, each of the one or more support arms having a proximal end portion coupled to the frame and a distal end portion protruding axially distally from the frame and adapted to extend into a ventricle, the one or more support arms adapted to stabilize the prosthetic heart valve inside the native heart valve.

22. 22. The prosthetic heart valve of claim 1, wherein at least a portion of the prosthetic heart valve includes one or more gripping features for engaging against a face of the native heart valve when one of the ventricular anchors fails to capture one or more of the native valve leaflets.

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

24. The prosthetic heart valve of any one of claims 1 to 23, wherein the frame has a non-abrasive surface that provides a surface roughness for engagement with the native valve leaflets.

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

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

27. 27. The prosthetic valve of claim 26, wherein the tip of the second anchor of the plurality of anchors protrudes to a radius less than or equal to a radius of the outer surface of the outer frame.

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

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

30. 30. The prosthetic valve of any of claims 26 to 29, wherein the tip of the second anchor of the plurality of anchors extends to a lower axial height in a proximal direction of the prosthetic valve compared to the tip of the first anchor of the plurality of anchors.

31. 1. A prosthetic valve configured to be deployed relative to a native valve between an atrium and a ventricle, one or more prosthetic valve leaflets; a valve body supporting the one or more prosthetic valve leaflets and having a proximal end portion and a distal end portion; one or more hook arm anchors coupled to the valve body, each adapted to anchor to the native valve by hooking onto a leaflet of the native valve; and one or more support arms coupled to the valve body, each having a proximal end portion coupled to the valve body and a distal end portion projecting distally from the valve body and configured to extend into the ventricle, the one or more support arms adapted to stabilize the prosthetic valve within the native valve.

32. 32. The prosthetic valve of claim 31, wherein the one or more hook arm anchors are positioned on a first portion of the valve body that extends across at least 180 degrees of the 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. 33. The prosthetic valve of claim 31 or 32, wherein the second portion of the valve body has a radially outward facing outer surface and includes a friction element for providing friction against the native valve.

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

35. The prosthetic valve of any one of claims 31 to 34, wherein the one or more support arms include a puncturing element for puncturing the heart wall of the ventricle, thereby securing the one or more support arms to the heart wall.

Images