Prosthetic valve for deployment

Abstract

Devices, systems, and methods for prosthetic valves. The prosthetic valves disclosed herein can be used to improve deployment, sealing, and anchoring to an implantation site. In an example, the implantation site may include a native heart valve or another implantation site. An example of a prosthetic valve may include a proximal tensioning body positioned at a proximal portion of the prosthetic valve and a distal tensioning body positioned at a distal portion of the prosthetic valve. A sealing skirt may have a proximal end portion coupled to the proximal tensioning body and a distal end portion coupled to the distal tensioning body. The sealing skirt may be tensioned by the proximal tensioning body and the distal tensioning body and deflectable to conform to the shape of the native valve.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 328,638, filed on April 7, 2022, the entire contents of each of which are hereby incorporated by reference. Technical Field

[0003] Certain features of the present disclosure are generally directed to implants that include a prosthetic valve for deployment. Background Art

[0004] The valves of the human heart, including the aortic valve, pulmonary valve, mitral valve, and tricuspid valve, function essentially like one-way valves that operate in sync with the pumping heart. The valves allow blood to flow downstream, but prevent blood from flowing upstream. Diseased heart valves exhibit damage, such as valve narrowing or regurgitation, which inhibits the valve's ability to control blood flow. Such damage reduces the heart's efficiency in pumping blood and can be a debilitating and life-threatening condition. For example, valvular insufficiency can lead to conditions such as cardiac hypertrophy and ventricular dilatation. Therefore, a great deal of effort has been made to develop methods and devices for repairing or replacing damaged heart valves.

[0005] Prostheses exist to correct problems associated with damaged heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace damaged natural heart valves. Recently, a great deal of effort has been devoted to developing replacement heart valves, particularly tissue-based replacement heart valves, which can be delivered with less trauma to the patient than through open-heart surgery. Replacement valves are designed to be delivered through minimally invasive surgery and even percutaneous surgery.

[0006] These replacement valves are generally intended to replace the function of a native valve by blocking blood flow in a first direction while allowing blood to flow freely in a second direction. However, problems arise when blood leaks around the outside of the replacement valve. For example, in the context of replacement heart valves, paravalvular leakage (PVL) has proven to be particularly challenging. Additional challenges relate to the ability of such prostheses to be affixed in an atraumatic manner relative to tissue within a lumen, such as any body lumen or cavity. Summary of the invention

[0007] Examples of prosthetic valves disclosed herein may relate to improvements in prosthetic valves. In examples, such prosthetic valves may include replacement heart valves. Examples may be used for improved anchoring and sealing of flows (e.g., paravalvular leaks) outside of the flow channel of a prosthetic valve. Various other improvements are disclosed.

[0008] Examples may relate to a prosthetic valve configured to be deployed to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets; a sealing body radially positioned outside of the one or more prosthetic valve leaflets and configured to seal a portion of the native valve; one or more anchors configured to anchor the one or more prosthetic valve leaflets to the native valve; and one or more magnets configured to pull the sealing body and at least one of the one or more anchors together.

[0009] An example may be directed to a method. The method may include deploying a prosthetic valve to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets, a sealing body positioned radially outside of the one or more prosthetic valve leaflets and configured to seal against a portion of the native valve, one or more anchors configured to anchor the one or more prosthetic valve leaflets to the native valve, and one or more magnets configured to pull the sealing body and at least one of the one or more anchors together.

[0010] Examples may relate to a prosthetic valve configured to be deployed to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets; and one or more anchors configured to anchor the one or more prosthetic valve leaflets to the native valve, each of the one or more anchors comprising one or more grooves configured to increase the flexibility of the corresponding anchor.

[0011] An example may be directed to a method. The method may include deploying a prosthetic valve to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets, and one or more anchors configured to anchor the one or more prosthetic valve leaflets to the native valve, each of the one or more anchors including one or more grooves configured to increase flexibility of the corresponding anchor.

[0012] Examples may relate to a prosthetic valve configured to be deployed to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets; and one or more anchors configured to anchor the one or more prosthetic valve leaflets to the native valve, each of the one or more anchors comprising a coil.

[0013] An example may be directed to a method. The method may include deploying a prosthetic valve to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets, and one or more anchors configured to anchor the one or more prosthetic valve leaflets to the native valve, each of the one or more anchors comprising a coil.

[0014] Examples may relate to a prosthetic valve configured to be deployed to a native valve. The prosthetic valve may include a valve body that surrounds a flow channel extending along a longitudinal dimension, one or more prosthetic valve leaflets that extend radially inward from the valve body and are positioned within the flow channel, and one or more anchors that are pivotally coupled to the valve body and configured to pivot about the longitudinal dimension to change the radial distance of the one or more anchors from the valve body.

[0015] An example may be directed to a method. The method may include deploying a prosthetic valve to a native valve. The prosthetic valve may include a valve body that encloses a flow channel extending along a longitudinal dimension, one or more prosthetic valve leaflets that extend radially inward from the valve body and are positioned within the flow channel, and one or more anchors that are coupled to the inner frame and are configured to pivot about the longitudinal dimension to change the radial distance of the one or more anchors from the valve body.

[0016] Examples may relate to a prosthetic valve configured to be deployed to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets; a sealing body positioned radially outside of the one or more prosthetic valve leaflets and configured to seal against a portion of the native valve; one or more anchors configured to anchor the one or more prosthetic valve leaflets to the native valve; and a band configured to have an adjustable diameter to move the sealing body radially inward or outward.

[0017] An example may be directed to a method. The method may include deploying a prosthetic valve to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets, a sealing body positioned radially outward of the one or more prosthetic valve leaflets and configured to seal against a portion of the native valve, one or more anchors configured to anchor the one or more prosthetic valve leaflets to the native valve; and a band configured to have an adjustable diameter to move the sealing body radially inward or outward.

[0018] Examples may relate to a prosthetic valve configured to be deployed to a natural valve. The prosthetic valve may include a valve frame surrounding a flow channel; one or more prosthetic valve leaflets, the one or more prosthetic valve leaflets being coupled to the valve frame and extending radially inward from the valve frame and positioned within the flow channel; and a sealing skirt, the sealing skirt being positioned radially outward from the valve frame, with a space between the sealing skirt and the valve frame, the sealing skirt being in tension and configured to deflect to conform to the shape of the natural valve.

[0019] An example may be directed to a method. The method may include deploying a prosthetic valve to a native valve. The prosthetic valve may include a valve frame surrounding a flow channel, one or more prosthetic valve leaflets, the one or more prosthetic valve leaflets being coupled to the valve frame and extending radially inward from the valve frame and positioned within the flow channel, and a sealing skirt positioned radially outward from the valve frame with a space between the sealing skirt and the valve frame, the sealing skirt being in tension and configured to deflect to conform to the shape of the native valve.

[0020] Examples may relate to a prosthetic valve configured to be deployed to a native valve. The prosthetic valve may include a valve frame surrounding a flow channel; one or more prosthetic valve leaflets coupled to the valve frame and extending radially inward from the valve frame and positioned within the flow channel; a sealing skirt positioned radially outward from the valve frame and including a pocket; and a ring positioned in the pocket and configured to support the sealing skirt.

[0021] An example may be directed to a method. The method may include deploying a prosthetic valve to a native valve. The prosthetic valve may include a valve frame surrounding a flow channel, one or more prosthetic valve leaflets coupled to the valve frame and extending radially inward from the valve frame and positioned within the flow channel, a sealing skirt positioned radially outward from the valve frame and including a pocket, and a ring positioned in the pocket and configured to support the sealing skirt.

[0022] Examples may relate to a prosthetic valve configured to be deployed to a native valve. The prosthetic valve may include a valve frame surrounding a flow channel; one or more prosthetic valve leaflets, the one or more prosthetic valve leaflets being coupled to the valve frame and extending radially inward from the valve frame and positioned within the flow channel; one or more anchors, the one or more anchors being configured to anchor the one or more prosthetic valve leaflets to the native valve; a sealing skirt, the sealing skirt being positioned radially outward from the valve frame and including a distal portion; and one or more slidable connectors, the one or more slidable connectors coupling the distal portion of the sealing skirt to the one or more anchors and being configured to allow the distal portion of the sealing skirt to slide relative to the one or more anchors.

[0023] An example may be directed to a method. The method may include deploying a prosthetic valve to a native valve. The prosthetic valve may include a valve frame surrounding a flow channel, one or more prosthetic valve leaflets, the one or more prosthetic valve leaflets coupled to the valve frame and extending radially inward from the valve frame and positioned within the flow channel, one or more anchors, the one or more anchors configured to anchor the one or more prosthetic valve leaflets to the native valve, a sealing skirt, the sealing skirt being positioned radially outward from the valve frame and including a distal portion, and one or more slidable connectors, the one or more slidable connectors coupling the distal portion of the sealing skirt to the one or more anchors and being configured to allow the distal portion of the sealing skirt to slide relative to the one or more anchors.

[0024] Examples may relate to a prosthetic valve configured to be deployed to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets; and one or more anchors configured to anchor the one or more prosthetic valve leaflets to the native valve, each of the one or more anchors comprising a T-bar.

[0025] An example may be directed to a method. The method may include deploying a prosthetic valve to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets, and one or more anchors configured to anchor the one or more prosthetic valve leaflets to the native valve, each of the one or more anchors comprising a T-bar.

[0026] An example may be directed to a prosthetic valve configured to be deployed to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets; a valve body supporting the one or more prosthetic valve leaflets; a plurality of distal anchors, each of the plurality of distal anchors comprising an elongated arm having a first end coupled to the valve body and extending radially outwardly from the first end of the corresponding elongated arm along a certain length to a tip, each elongated arm being configured to be hooked on a distal tip of a native valve leaflet to anchor the one or more prosthetic valve leaflets to the native valve; and a sealing skirt forming a disc extending circumferentially along the length of each of the elongated arms and between adjacent elongated arms.

[0027] An example may be directed to a method. The method may include deploying a prosthetic valve to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets, a valve body supporting the one or more prosthetic valve leaflets, a plurality of distal anchors, each of the plurality of distal anchors comprising an elongated arm having a first end coupled to the valve body and extending radially outwardly from the first end of the corresponding elongated arm along a length to a tip, each elongated arm being configured to be hooked onto a distal tip of a native valve leaflet to anchor the one or more prosthetic valve leaflets to the native valve, and a sealing skirt forming a disc extending circumferentially along the length of each of the elongated arms and between adjacent elongated arms.

[0028] Examples may relate to a prosthetic valve configured to be deployed to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets; and one or more anchors configured to anchor the one or more prosthetic valve leaflets to the native valve, each of the one or more anchors comprising a hinge configured to allow radial deflection of the corresponding anchor.

[0029] An example may involve a method. The method may include deploying a prosthetic valve to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets, and one or more anchors configured to anchor the one or more prosthetic valve leaflets to the native valve, each of the one or more anchors comprising a hinge configured to allow radial deflection of the corresponding anchor.

[0030] Examples may relate to a prosthetic valve configured to be deployed to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets; an inner frame that supports the one or more prosthetic valve leaflets; an outer frame that is positioned radially outward from the inner frame and surrounds the inner frame, the outer frame being separated from the inner frame by a gap; and one or more anchors that are coupled to the outer frame and are each configured to be positioned radially outside of one or more leaflets of the native valve to anchor to the native valve.

[0031] An example may be directed to a method. The method may include deploying a prosthetic valve to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets, an inner frame supporting the one or more prosthetic valve leaflets, an outer frame positioned radially outward from the inner frame and surrounding the inner frame, the outer frame being separated from the inner frame by a gap, and one or more anchors coupled to the outer frame and each configured to be positioned radially outward of the one or more leaflets of the native valve to anchor to the native valve.

[0032] An example may be directed to a prosthetic valve configured to be deployed to a native valve. The prosthetic valve may include one or more prosthetic valve leaflets; and a frame comprising an outer frame and an inner frame, the outer frame and the inner frame being cut from a single piece of material such that the outer frame is integral with the inner frame, the outer frame deflecting radially outward from the inner frame and comprising a plurality of struts defining a plurality of openings, the inner frame being configured to support the one or more prosthetic valve leaflets and comprising a plurality of struts defining a plurality of openings, and at least a portion of the inner frame being aligned within at least one of the plurality of openings of the outer frame, or at least a portion of the outer frame being aligned within at least one of the plurality of openings of the inner frame.

[0033] An example may be directed to a method. The method may include deploying a prosthetic valve to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets, a frame, the frame comprising an outer frame and an inner frame, the outer frame and the inner frame being cut from a single piece of material such that the outer frame is integral with the inner frame, the outer frame deflecting radially outward from the inner frame and comprising a plurality of struts defining a plurality of openings, the inner frame being configured to support the one or more prosthetic valve leaflets and comprising a plurality of struts defining a plurality of openings, and at least a portion of the inner frame being aligned within at least one of the plurality of openings of the outer frame, or at least a portion of the outer frame being aligned within at least one of the plurality of openings of the inner frame.

[0034] Any of the features of the examples disclosed herein are applicable to all other aspects and examples identified herein. In addition, any of the features of the examples in the various examples can be independently combined in part or completely with other examples described herein in any way, for example, one, two or three or more examples can be combined in whole or in part. In addition, any of the features of the examples can be optional for other aspects or examples. Any example of the method can be performed by the system or device of another example, and any example of the system or device can be configured to perform the method of another example. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The features and advantages of the systems, devices and methods as disclosed herein will also become better understood with reference to the specification, claims and drawings, in which:

[0036] Figure 1 A top perspective view of a prosthetic valve according to an example of the present disclosure is shown.

[0037] Figure 2 Shown Figure 1 Bottom perspective view of the prosthetic valve shown in .

[0038] Figure 3 Shown Figure 1 Schematic side cross-section of the prosthetic valve shown in .

[0039] Figure 4 A schematic diagram of the delivery device approaching the implantation site is shown.

[0040] Figure 5 Shown Figure 1 Schematic side cross-sectional view of a prosthetic valve positioned within a delivery device is shown in FIG.

[0041] Figure 6 Shown Figure 1Schematic side cross-section of a prosthetic valve deployed to a native heart valve is shown in .

[0042] Figure 7 Shown Figure 1 Schematic side cross-section of a prosthetic valve after deployment to a native heart valve as shown in .

[0043] Figure 8 Shown Figure 7 Detailed view of the magnetic attraction between the anchor and the seal body shown in .

[0044] Fig. 9 A side cross-sectional view of the anchor is shown.

[0045] Fig.10 A side cross-sectional view of the anchor is shown.

[0046] Fig.11 A side view of the anchor is shown.

[0047] Fig.12 Shown Fig.11 Side cross-sectional view of the anchor shown in .

[0048] Fig.13 Shown along Fig.12 A cross-sectional view of line AA shown in FIG.

[0049] Fig.14 A perspective view of a prosthetic valve is shown.

[0050] Fig.15 Shown Fig.14 Top cross-sectional view of the prosthetic valve shown in .

[0051] Fig.16 Shown Fig.14 Top cross-sectional view of the prosthetic valve shown in .

[0052] Fig.17 Shown Fig.14 Top cross-sectional view of a prosthetic valve shown in , with the native valve leaflets shown in phantom.

[0053] Fig.18 A top cross-sectional view of the prosthetic valve is shown.

[0054] Fig.19 A side cross-sectional view of the lock is shown.

[0055] Fig. 20 Shown Fig.19 Side cross-sectional view of the lock shown in .

[0056] Fig.21 A perspective view of a prosthetic valve is shown.

[0057] Fig. 22 A partial cross-sectional perspective view of a prosthetic valve is shown.

[0058] Fig.23 Shown Fig. 22 A partial cross-sectional perspective view of a prosthetic valve shown in FIG.

[0059] Fig.24 Shown Fig. 22 Top cross-sectional view of the prosthetic valve shown in .

[0060] Fig.25 A top view of the belt is shown.

[0061] Fig.26 A schematic diagram showing a portion of a belt is shown.

[0062] Fig. 27 A side cross-sectional view of the prosthetic valve is shown.

[0063] Fig.28 Shows from Fig. 27 Move to the position shown in Fig. 27 Side cross-sectional view of the prosthetic valve shown in .

[0064] Fig.29 Shown Fig. 27 A perspective view of the prosthetic valve shown in FIG.

[0065] Fig.30 Shown Fig. 27 Side cross-sectional view of a prosthetic valve after deployment to a native heart valve is shown in .

[0066] Fig.31 A perspective view of a prosthetic valve is shown.

[0067] Fig.32 Shown Fig.31 Side cross-sectional view of the prosthetic valve shown in .

[0068] Fig.33 A perspective view of a prosthetic valve is shown.

[0069] Fig.34 A perspective view of a prosthetic valve is shown.

[0070] Fig.35 A perspective view of a prosthetic valve is shown.

[0071] Fig.36 A side cross-sectional view of the prosthetic valve is shown.

[0072] Fig.37 A top view of the ring is shown.

[0073] Fig.38 A side cross-sectional view of the prosthetic valve is shown.

[0074] Fig.39 A side cross-sectional view of the prosthetic valve is shown.

[0075] Fig.40 A side cross-sectional view of a slidable coupler sliding along an anchor is shown.

[0076] Fig.41 A side cross-sectional view of a slidable coupler sliding along an anchor is shown.

[0077] Fig.42 A side cross-sectional view of the prosthetic valve is shown.

[0078] Fig.43 Shown Fig.42 Top schematic diagram of the prosthetic valve shown in .

[0079] Fig.44 Shown Fig.42 Side view of the prosthetic valve shown in FIG. 1 after deployment to the implantation site.

[0080] Fig.45 A perspective view of a prosthetic valve is shown.

[0081] Fig.46 Shown Fig.45 A perspective view of an anchor of a prosthetic valve is shown in FIG.

[0082] Fig.47 Shown Fig.45 Top schematic diagram of the prosthetic valve shown in .

[0083] Fig.48 Shown Fig.45 A top view of the anchor shown in FIG.

[0084] Fig.49 Shown Fig.45 A top view of the anchor shown in FIG.

[0085] Fig.50 A top view of the anchor is shown.

[0086] Fig.51 A top schematic diagram showing a portion of a prosthetic valve.

[0087] Fig.52 Shown Fig.51 A perspective view of the portion of the prosthetic valve shown in FIG.

[0088] Fig.53 A cross-sectional perspective view of a prosthetic valve is shown.

[0089] Fig.54 Shown Fig.53 Side cross-sectional view of a prosthetic valve after deployment to an implantation site is shown in FIG.

[0090] Fig.55A and 55B Each shows a side cross-sectional view of an anchor.

[0091] Fig.56 A side cross-sectional view of the anchor is shown.

[0092] Fig.57 A schematic side cross-sectional view of a prosthetic valve positioned within a delivery device is shown.

[0093] Fig.58 Shown Fig.57 Schematic side cross-section of a prosthetic valve deployed to a native heart valve is shown in .

[0094] Fig.59 Shown Fig.57 Schematic side cross-section of a prosthetic valve deployed to a native heart valve is shown in .

[0095] Fig.60 Shown Fig.57 Schematic side cross-section of a prosthetic valve deployed to a native heart valve is shown in .

[0096] Fig.61 Shown Fig.57 Schematic side cross-section of a prosthetic valve deployed to a native heart valve is shown in .

[0097] Fig.62 Shown Fig.57 Schematic side cross-section of a prosthetic valve after deployment to a native heart valve as shown in .

[0098] Fig.63 A side view of the internal frame is shown.

[0099] Fig.64 A side view of the external frame is shown.

[0100] Fig.65 Shown Fig.64 The connection shown in Fig.63 A perspective view of the outer frame of the inner frame shown in FIG.

[0101] Fig.66 Shown Fig.64 The connection shown in Fig.63 Side view of the outer frame of the inner frame shown in .

[0102] Fig.67 Shown Fig.64The connection shown in Fig.63 A top view of the outer frame of the inner frame shown in FIG.

[0103] Fig.68 A schematic side cross-section of a prosthetic valve after deployment to a native heart valve is shown.

[0104] Fig.69 A side cross-sectional view of an anchor and a portion of a prosthetic valve is shown.

[0105] Fig.70 Shown Fig.69 Side cross-sectional view of an anchor shown anchored to a native valve leaflet.

[0106] Fig.71 A perspective view of the exterior frame is shown.

[0107] Fig.72 Shown Fig.71 Schematic side cross-section of a portion of the outer frame shown in .

[0108] Fig.73 A schematic side cross-sectional view of a prosthetic valve positioned within a delivery device is shown.

[0109] Fig.74 A schematic side cross-sectional view of a prosthetic valve deployed from a delivery device is shown.

[0110] Fig.75 A schematic side cross-sectional view of a prosthetic valve deployed from a delivery device is shown.

[0111] Fig.76 Shown Fig.73 Schematic side cross-section of a prosthetic valve after deployment to a native heart valve as shown in .

[0112] Fig.77 A perspective view of the frame is shown.

[0113] Fig.78 Shows from Fig.77 Rotated to the position shown in Fig.77 A perspective view of the frame shown in FIG.

[0114] Fig.79 Shown Fig.77 A side view of the frame shown in FIG.

[0115] Fig.80 Shows from Fig.77 Rotated to the position shown in Fig.77 A side view of the frame shown in FIG.

[0116] Fig.81 Shown Fig.77A top view of the frame shown in FIG.

[0117] Fig.82 Shown Fig.77 As shown in Fig.77 A side view of the inner frame separated from the outer frame shown in FIG.

[0118] Fig.83 Shown Fig.77 As shown in Fig.77 A side view of the outer frame with the inner frame separated is shown in FIG.

[0119] Fig.84 Shown Fig.77 A side view of the frame shown in FIG. 1 in a curled or compressed configuration.

[0120] Fig.85 Shown Fig.77 shown in a crimped or compressed configuration and from Fig.84 Side view of the frame with the position rotated as shown.

[0121] Fig.86 Shown Fig.77 A top schematic diagram of the frame shown in FIG. 1 in a curled or compressed configuration.

[0122] Fig.87 A perspective view of the frame is shown.

[0123] Fig.88 A perspective view of the frame is shown.

[0124] Fig.89 Shown Fig.88 Detailed view of a portion of the frame shown in .

[0125] Fig.90 A schematic side cross-section of a prosthetic valve is shown.

[0126] Fig.91 A side view of the strut unit of a prosthetic valve is shown.

[0127] Fig.92 A schematic side view of a portion of a prosthetic valve is shown.

[0128] Fig.93 A schematic side cross-section of a prosthetic valve is shown. DETAILED DESCRIPTION

[0129] Figure 1A perspective view of a prosthetic valve 10 in the form of a replacement heart valve is shown. The prosthetic valve 10 can be configured to be deployed within a portion of a patient's body. For example, the prosthetic valve 10 can be deployed within the annulus of a native valve, such as a native mitral valve or a native tricuspid valve. In an example, other implantation locations can be used, such as within the aortic valve or pulmonary valve, or other valves or locations within the patient's body as needed.

[0130] The prosthetic valve 10 may include a proximal end 12 and a distal end 14 (at Figure 3 ) and the length thereof. The prosthetic valve 10 may further include one or more prosthetic valve leaflets 16, or a plurality of prosthetic valve leaflets 16, configured to enclose a flow channel for controlling flow through the valve 10. The prosthetic valve leaflets 16 are configured to move between an open state and a closed state to mimic and replace the operation of a natural valve leaflet. In an example, the prosthetic valve leaflets 16 may be coupled to a frame or an intermediate fabric portion that connects the leaflets to the frame. The frame may include an inner frame 18, such as Figure 2 and Figure 3 , and may include an outer frame 20, such as Figure 1 and 3 As shown in , the outer frame may be part of the sealing body 11 and may be spaced radially outward from the inner frame 18 .

[0131] Figure 3 A schematic cross-sectional view of a prosthetic valve 10 is shown. An inner frame 18 includes a proximal portion having a proximal end 19 and a distal portion having a distal end 21. The inner frame 18 can have a spherical shape including a curved body that curves radially outward between the proximal end 19 and the distal end 21, or can have another configuration in an example as desired. In an example, the inner frame 18 can have a ring shape. The prosthetic valve leaflet 16 is positioned within the inner frame 18.

[0132] refer to Figure 2 , the internal frame 18 can include a plurality of struts 23 and spaces 15 therebetween. Such a configuration can allow the internal frame 18 to move between an undeployed, unexpanded, or linearized configuration and an deployed or expanded configuration. For example, the internal frame 18 can expand radially outward to move to the deployed or expanded configuration, and as the diameter of the internal frame 18 increases, the length of the internal frame 18 decreases. Other configurations of the internal frame 18 can be used as desired.

[0133] refer to Figure 1 and 3, the prosthetic valve 10 preferably includes one or more anchors 17 that can be connected to the prosthetic valve leaflets 16. The anchors 17 are shaped to anchor the prosthetic valve 10 to a portion of the patient's heart, such as a native valve. The anchors 17 can be specifically configured to anchor to the native valve leaflets of the patient's heart. The anchors 17 can extend around the native valve leaflets to anchor to the native valve leaflets. The anchors 17 can include a distal anchor positioned at the distal end 14 of the valve 10, or in an example can be positioned in another position, such as a distal anchor along the middle region of the valve 10.

[0134] Each anchor 17 can be configured as a protruding arm that is configured to extend distally and then bend in the proximal direction to the tip of the corresponding one of the anchors 17. Such a configuration can allow the anchor 17 to extend around the native leaflet and around the distal tip of the leaflet to hook onto the distal tip of the native valve leaflet and be positioned radially outside of the outward-facing surface of the leaflet of the native valve. For example, the anchor 17 can be configured in a hook-shaped configuration, such as Figure 1-3 Thus, the anchor 17 can resist forces applied to the valve 10 in the atrial or proximal direction and can anchor the valve 10 to the native valve annulus. Other configurations of the anchor 17 can be used in an example as desired.

[0135] Anchor 17 Figure 1-3 17 is shown in a deployed or expanded configuration, wherein the tip of the anchor 17 extends proximally. In an example, the anchor 17 can be configured in an undeployed, unexpanded, or linearized configuration, wherein the tip of the anchor 17 extends distally. For example, such a configuration is shown in Figure 5 In an example, the anchor 17 can be configured to be flexible. Once deployed, the anchor 17 can be configured to move radially outward from the undeployed configuration to the deployed configuration, with the tip flipped in the proximal direction. Such operation can allow the anchor 17 to flip behind the native valve leaflet to capture the native valve leaflet during deployment. Such a configuration is shown in Figure 7 , wherein the native leaflet 82 is located between the anchor 17 and the outer sealing frame 11. Other methods of deploying the anchor 17 may be utilized in an example as desired.

[0136] refer to Figure 3, the prosthetic valve leaflets 16 are supported within the inner frame 18. For example, the proximal portion of the inner frame 18 can be coupled to the proximal portions of the plurality of prosthetic valve leaflets 16. The prosthetic valve leaflets 16 can be coupled to the inner frame 18 and can extend radially inward from the inner frame 18. The prosthetic valve leaflets 16 can be coupled to the valve frame 18 by an intermediate body 28, which can support the prosthetic valve leaflets 16 and can couple the leaflets 16 to the inner frame 18 by sutures or another method as desired.

[0137] The prosthetic valve leaflets 16 surround the flow channel 25, such as Figure 3 , and can be moved between an open state and a closed state to control the flow through the flow channel 25. Figure 3 As shown in , the proximal end of the prosthetic valve 10 can include the inflow end of the valve 10, and the distal end of the prosthetic valve 10 can include the outflow end, but other configurations can be used as desired. The prosthetic valve leaflets 16 can be positioned around the central axis 61 of the prosthetic valve 10. The inner frame 18 and the outer frame 20 can each surround the central axis 61 of the prosthetic valve 10.

[0138] The anchors 17 can each extend radially outward from the flow channel 25 and radially outward from the prosthetic valve leaflets 16 of the valve 10. The anchors 17 can be coupled to a distal portion of the inner frame 18. The anchors 17 can each include a proximal portion 27 and a distal portion 29, and the proximal portion 27 is coupled to the inner frame 18, and the distal portion 29 includes a tip of the corresponding anchor 17. When the valve 10 is deployed, the anchors 17 can extend vertically from the proximal portion 27 to a tip at the distal portion 29.

[0139] Reference again Figure 1 The prosthetic valve 10 preferably includes an outer sealing body 11. The sealing body 11 can be positioned radially outward from the prosthetic valve leaflet 16 and can be configured to seal a portion of the native valve. The sealing body 11 forms an outer surface of the valve 10. The sealing body 11 can define an outer diameter of the valve 10 and can include an outer periphery of the valve 10. The sealing body 11 includes a proximal portion having a proximal end 31 and a distal portion having a distal end 33 (at Figure 3 (marked in).

[0140] refer to Figure 3 , the sealing body 11 includes a frame 20 and a sealing skirt 24, or may include only the frame or only the sealing skirt in an example as desired. In the illustrated embodiment, the frame 20 includes an outer frame positioned radially outward from the inner frame 18. The sealing skirt 24 is coupled to the outer frame 20 and forms an outer portion of the sealing body 11, such as Figure 1 as shown in .

[0141] At least a portion of the sealing body 11 is configured to engage surrounding tissue and thereby form a seal. The outer frame 20 is radially positioned outside the inner frame 18. The outer frame 20 may have a proximal portion 35 that is coupled to the proximal end 19 of the inner frame 18. The proximal portion 35 may extend radially outward from the proximal end 19 of the inner frame 18 and from the prosthetic valve leaflet 16. The distal portion 37 of the outer frame 20 may be spaced apart from the prosthetic valve leaflet 16 and the inner frame 18 by a gap 39. The gap 39 may be positioned between the outer frame 20 of the sealing body 11 and the distal portion of the inner frame 18. Therefore, the inner frame 18 may include an inner frame, and the frame 20 of the sealing body 11 may include an outer frame that is radially positioned outside the inner valve frame 18 and surrounds the inner frame 18 and the prosthetic valve leaflet 16.

[0142] The length of the outer frame 20 can extend distally to a lesser distance than the distal end of the inner frame 18. Thus, in the expanded state, the outer frame 20 can be shorter than the inner frame 18. The outer frame 20 can further have a curved configuration that curves outward from the inner frame 18, wherein the largest diameter of the outer frame 20 is located along the distal portion of the outer frame 20.

[0143] The outer frame 20 of the sealing body 11 includes a plurality of struts 49 (eg, Figure 1 ) and having spaces 51 between the struts. Such a configuration utilized with the frame 20 can allow the frame 20 to move between an undeployed, unexpanded, or linearized configuration and a deployed or expanded configuration, such as Figure 1 , where the outer frame 20 and the sealing body 11 have a curved spherical shape. As with the valve frame 18, during deployment, as the diameter of the outer frame 20 of the sealing body 11 increases, the length of the outer frame 20 of the sealing body 11 may decrease. In an example, the diameter of the outer frame 20 of the sealing body 11 can be expanded radially outward from the inner valve frame 18 at the same time or at a different expansion time or rate than the inner valve frame 18.

[0144] The sealing body 11 may include a sealing skirt 24 (eg Figure 1 ), the sealing skirt may extend around the inner valve frame 18 and the prosthetic valve leaflets 16. The skirt 24 may be directly coupled to the frame 20 of the sealing body, or may not expand outwardly from the frame 20.

[0145] The sealing skirt 24 may have a proximal portion 41 (at Figure 3The skirt 24 may have a distal portion 43 (marked in FIG. 1 ), which is coupled to the proximal portion of the sealing body 11 and may also be coupled to the proximal portion of the inner frame 18. Figure 3 ), the distal portion can be coupled to the distal end of the frame 20, and in an example can be coupled to one or more of the inner valve frame 18 or the anchor 17. Figure 3 As shown, the anchors 17 are configured to extend radially outward from the inner valve frame 18 and through the gaps 39 to the tips of the respective anchors 17 .

[0146] The sealing skirt 24 is preferably made of a material that resists fluid flow through it, such as cloth, woven material or other material, such as a polymer or other material that resists fluid flow through it. The material may include fabric. A variety of materials can be used for the skirt 24 as needed.

[0147] The sealing body 11 can be configured to abut a portion of the patient's heart to reduce fluid flow. The skirt 24 can be configured to seal a portion of the native valve annulus. For example, the sealing body 11 can abut the surface of the patient's native valve leaflet to reduce fluid flow between the sealing body 11 and the native leaflet. The sealing body 11 can be configured to abut other portions of the patient's heart to reduce fluid flow as needed.

[0148] In an example, the sealing body 11 can be flexible to allow movement and conformity to the native valve annulus.

[0149] In an example, one or more magnets can be used to pull portions of the prosthetic valve 10 toward each other. For example, one or more magnets can be configured to pull the anchor 17 toward the sealing body 11. Magnets can also be provided at other locations for pulling other portions of the prosthetic valve together as desired.

[0150] refer to Figure 1 , one or more magnets can be positioned at various locations on the prosthetic valve 10. In one example, one or more of the magnets are incorporated into or attached to the anchor 17. Magnets 62 can be positioned on each of the anchors 17, and are preferably positioned on the tip of the anchor 17. In an example, each magnet 62 can be positioned on the anchor 17 such that the magnets 62 are circumferentially spaced apart from each other and radially outwardly spaced apart from the sealing body 11.

[0151] In an example, one or more magnets 64 can be positioned on the sealing body 11. The magnets 64 can be positioned on the sealing body 11 and spaced circumferentially from each other. In an example, the magnets 64 can be positioned to be circumferentially aligned with the magnets 62 on the anchor 17, or can be in another position. For example, the magnet 64 can be adjacent to the magnet 62 that is still on the other side of the natural valve leaflet. The magnet 64 can be positioned close to the magnet 62 on the anchor 17. The magnet 64 can be connected to the outer frame 20, or can be embedded in the sealing skirt 24, or can be connected to the sealing body 11 in other ways. The outer frame 20 can include a proximal portion 63 and a distal portion 65 that can be connected to the inner frame 18. In an example, the magnet 64 can be positioned on the distal portion 65 or in another position.

[0152] In an example, the magnet 62 on the anchor 17 is configured to interact with an opposing magnet 64 located on the sealing body 11. For example, the polarity of the magnets 62, 64 can be arranged so as to provide an attractive magnetic force between the magnets 62, 64 to draw the magnets 62, 64 toward each other. In a corresponding manner, the respective anchor 17 and the sealing body 11 can be pulled toward each other.

[0153] In examples, magnetically responsive materials such as ferromagnetic materials can be used in combination or in place of magnets. For example, a ferromagnetic material such as iron or another metal or alloy can be used to attract one of the magnets 62, 64. The ferromagnetic material can, for example, be replaced by the magnet 62 on the anchor 17 and can be attracted to the magnet 64 on the sealing body 11. Similarly, the ferromagnetic material can replace the magnet 64 on the sealing body 11 and can be attracted to the magnet 62 on the anchor 17. Combinations of magnets and ferromagnetic materials can be used in examples as desired.

[0154] Figure 4 Advancement of a delivery system 70 for deploying a prosthetic valve 10 to an implantation site is shown. The delivery system 70 may include an elongated shaft 72 having a proximal portion and a distal portion, wherein the proximal portion is coupled to a housing in the form of a handle 74. The delivery system 70 may be advanced through a patient's vasculature, such as a femoral vein, such as Figure 4 Other terms may be used in examples including transapical, or by surgical approaches such as thoracotomy or open heart surgery.

[0155] The prosthetic valve 10 can be positioned within the implant retention region of the delivery system 70 and can be covered with a capsule or can be otherwise retained prior to deployment. The prosthetic valve 10 can be deployed as a self-expanding prosthesis or can be a balloon-expandable prosthesis (e.g., positioned on an expandable balloon upon entry into the patient's body, or slid onto an expandable balloon within the patient's body), or can be mechanically expandable, among other forms of deployment.

[0156] The delivery system 70 can be advanced to be delivered into an atrium of the heart and can be delivered transseptally into the other atrium (e.g., from the right atrium to the left atrium) to reach the implantation site. For example, this delivery method can be used for mitral native valve access. In an example, the delivery system 70 can be extended to the right atrium for tricuspid valve access, or other delivery methods to other implantation sites can be used in an example as needed.

[0157] Figure 5 A side cross-sectional view of the prosthetic valve 10 in a compressed configuration within the capsule 79 of the delivery system 70 is shown. The anchor 17 is shown extending longitudinally in an elongated configuration. The prosthetic valve 10 can be positioned for deployment to a native valve 80.

[0158] Figure 6 The prosthetic valve 10 is shown partially deployed to the native valve 80. The anchor 17 can be advanced and can be deployed radially outward from the capsule 79. The anchor 17 can be hooked onto the native valve leaflet 82 so that the tip of the anchor 17 is positioned radially outside of the native valve leaflet 82. Thus, the magnet 62 coupled to the anchor 17 can be positioned radially outside of the native valve leaflet 82.

[0159] Figure 7 The prosthetic valve 10 is shown deployed to a native valve 80. A magnet 62 coupled to the anchor 17 is positioned radially outside of the native valve leaflets 82. A magnet 64 coupled to the seal body 11 is positioned radially inside of the native valve leaflets 82. The magnets 62, 64 may be circumferentially aligned with one another and may be axially aligned with one another to provide an attractive magnetic force between the magnets 62, 64.

[0160] Figure 8 An enlarged view of the magnets 62, 64 interacting with each other is provided.The magnets 62, 64 can be positioned on opposite sides of the native valve leaflets 82 to provide an attractive magnetic force (indicated by lines 84) through the native valve leaflets 82.

[0161] The magnets 62, 64 can be configured to enhance the grip of the native valve leaflets 82 between the sealing body 11 and the anchor 17. The additional gripping force applied by the magnets 62, 64 can provide various benefits, including improved anchoring of the prosthetic valve 10 to the native valve and enhanced sealing of fluid flow around the prosthetic valve 10 (e.g., paravalvular leak). The compression applied to the native valve leaflets 82 by the magnets 62, 64 can press the sealing body 11 relative to the native valve leaflets 82 and enhance the seal provided by the sealing body 11. In an example, one or more of the magnets 62, 64 can be supplemented or replaced with a magnetically responsive material such as a ferromagnetic material as desired.

[0162] Figure 1-8 Features of the examples may be used alone or in combination with any other features disclosed herein.

[0163] Fig. 9 Another example of an anchor 90 that can be used in the examples herein is shown. Anchor 90 can be configured to secure a prosthetic valve and prosthetic valve leaflets to a native valve, which can be used with Figure 1-3 The anchor 17 is shown in a similar manner.

[0164] The anchor 90 can include an elongated arm including a first portion 92 or inner portion and extending radially outward to a second portion 94 or outer portion including a tip 96. The elongated arm has a length. The first portion 92 can be coupled to the valve body 91, and the elongated arm can extend radially outward from the valve body 91 to the tip 96. For example, the valve body 91 can be connected to the valve body 91. Figure 1-3 The valve body shown in FIG. 1 supports one or more prosthetic valve leaflets in a manner similar to that of the valve body shown in FIG.

[0165] The anchor 90 may be in a hook-shaped configuration and may include a curved portion 98 having a convex curvature with a radially inwardly facing surface 100 and a radially outwardly facing surface 102. The anchor 90 may be configured to Figure 1-3 The anchor 17 shown in FIG. 1 is hooked onto the distal tip of the native valve leaflet in a similar manner.

[0166] The anchor 90 preferably includes one or more grooves 104 configured to increase the flexibility (i.e., reduce bending stiffness) of the anchor 90. The one or more grooves 104 can extend transversely relative to the length of the anchor 90. In an example, a plurality of grooves 104 can be provided, and the plurality of grooves can be spaced apart from each other along the length of the anchor 90. Fig. 9 As shown in FIG. 8 , one or more grooves 104 may be positioned on the curved portion 98 and may be positioned on the radially inward facing surface 100 .

[0167] One or more grooves 104 are configured to increase the flexibility of the anchor 90 in the radially inward direction. This configuration can be used to maintain stiffness in the outward direction while increasing flexibility in the inward direction. Fig. 9 As shown by the arrows shown in , anchor 90 can be configured to deflect radially inward when implanted. This flexibility can provide various benefits, which can include reducing electrical conduction interference with the native valve annulus and reducing the possibility of damaging the native valve. Enhanced deployment, connection and conformability within the native valve can be achieved.

[0168] Fig.10An example of an anchor 106 formed by grooves on two sides is shown. More specifically, the anchor includes one or more grooves 108 on an inwardly facing surface 110 and one or more grooves 112 on an outwardly facing surface 114. The grooves 112 on the outwardly facing surface 114 can be configured similarly to the grooves 108 on the inwardly facing surface 110, which can be similar to the grooves 104. Enhanced flexibility in both the radially inward direction and the radially outward direction can be achieved.

[0169] Thus, the anchor may be unidirectional or bidirectional, or may have other directions of flexibility in examples. The increased flexibility of the anchor may increase the likelihood of ventricular remodeling, and may reduce the likelihood of conduction disturbances in the ventricle. The anchor may flex as the ventricle remodels.

[0170] Fig. 9 and 10 Features of the examples may be used alone or in combination with any other features disclosed herein.

[0171] Figure 11-13 Another example of an anchor 120 that can be used in the examples herein is shown. The anchor 120 is suitable for assisting in Figure 1-3 The anchor 17 shown in Figure 1 secures the prosthetic valve within the native valve in a similar manner.

[0172] The anchor 120 can include an elongated arm that can include a first portion 122, an inner portion or a coupling portion, and can extend radially outward to a second portion 124 or an outer portion including a tip portion 126. The elongated arm can have a certain length. The first portion 122 can be used to couple to a valve body 128, and the elongated arm can extend radially outward from the valve body 128 to the tip portion 126. For example, the valve body 128 can be connected to the valve body 128. Figure 1-3 The valve body shown in FIG. 1 supports one or more prosthetic valve leaflets in a manner similar to that of the valve body shown in FIG.

[0173] The anchor 120 can be in a hook-shaped configuration and can include a curved portion 130 having a convex curvature with a radially inwardly facing surface 132 and a radially outwardly facing surface 134. The anchor 120 can be configured to Figure 1-3 The anchor 17 shown in FIG. 1 is hooked onto the distal tip of the native valve leaflet in a similar manner. The radially inwardly facing surface 132 may comprise the inner radius of the anchor 120 , and the radially outwardly facing surface 134 may comprise the outer radius of the anchor 120 .

[0174] Fig.12 Shown Fig.111. A cross-sectional view of an anchor 120 is shown in FIG. The anchor 120 shown includes a coil 136. The coil 136 may include a first portion 138, an inner portion or a coupling portion, and may extend radially outward to a second portion 140. The coil 136 may form an elongated arm and may extend radially outward from the coupling portion of the anchor 120 to the tip portion 126 of the anchor. The coil may be integral with the coupling portion, or may be a separate component attached thereto.

[0175] The coil 136 may include a spring coil, and may include a wire bent into a spiral shape. In an example, the coil 136 may include a hypotube cut into a coil configuration, or may have another configuration as desired.

[0176] The coil 136 can have a first coil portion 142 that can be stiffer than a second coil portion 144. For example, the first coil portion 142 can include a coil that is wound more tightly than the second coil portion 144, and the second coil portion 144 can be more flexible than the first coil portion 142. The second coil portion 144 can include a gap that allows the coil to be locally compressed and fully bent at the second coil portion 144. The second coil portion 144 can be positioned in a variety of locations, including radially outside of the first coil portion 142, such as Fig.12 . In an example, the second coil portion 144 can be radially positioned inside the first coil portion 142 having greater rigidity. In an example, multiple portions of the coil 136 can have greater or lesser rigidity and can be variably positioned as desired. For example, portions with less rigidity can be interlaced with portions with greater rigidity as desired.

[0177] In an example, the second coil portion 144 having less stiffness can be positioned along the curved portion 130 of the anchor 120 to enhance the flexibility of the anchor 120 at the apex or angled portion of the anchor 120. Thus, the anchor 120 can be able to deflect more easily at the second coil portion 144 than at the first coil portion 142.

[0178] In an example, the third coil portion 146 can be positioned radially outside of the second coil portion 144. The third coil portion 146 can be stiffer than the second coil portion 144 and can extend radially outward to the tip portion 126 of the anchor 120. In an example, the second coil portion 144 can be positioned between the first coil portion 142 and the third coil portion 146 to provide greater flexibility at the apex or angled portion of the anchor 120 located between the stiffer first coil portion 142 and the third coil portion 146. Thus, the anchor 120 can have greater flexibility at the second coil portion 144.

[0179] In various examples, the anchor 120 can further include a reinforcing arm 148. The reinforcing arm 148 includes an elongated arm that extends along the coil 136 and can increase the stiffness of the anchor 120. The reinforcing arm 148 can include a first portion 150 or inner portion and can extend radially outward to a second portion 152 or outer portion. The length of the reinforcing arm 148 can extend from the first portion 138 of the coil 136 to the second portion 140 of the coil 136 along the length of the coil 136, and can extend from the first portion 122 of the anchor 120 to the second portion 124 of the anchor 120 along the length of the anchor 120.

[0180] The reinforcing arm 148 can extend parallel to the length of the coil 136 and can extend along the outer radius of the anchor 120. The reinforcing arm 148 can be positioned outside the coil 136. The reinforcing arm 148 can be positioned on one side of the coil 136 circumferentially relative to the coil 136 and outside the coil 136 along the outer radius. For example, Fig.13 Shown along Fig.12 A cross-sectional view of the anchor 120 along line AA in FIG. Fig.13 A reinforcing arm 148 is shown on one side of the coil 136 and along the outer radius of the coil 136. One or more reinforcing arms may be provided at other locations as desired. For example, in an example, the reinforcing arm may be positioned along the inner radius of the anchor 120 or along the neutral axis of the coil 136. Multiple reinforcing arms may be used in various locations as desired.

[0181] The reinforcement arms 148 can reinforce the anchor 120 and support the anchor 120 from circumferential loads (e.g., entry and exit). Fig.12 ). The reinforcing arms 148 can further reduce the likelihood that the anchor 120 will undesirably deflect radially outward from the valve body. In an example, the reinforcing arms can be excluded as desired.

[0182] In an example, the anchor 120 can include a cover 154 that can be positioned over the coil 136 and the reinforcing arm 148. The cover 154 can protect the interior of the anchor 120 including the coil 136 and the reinforcing arm 148. The cover 154 can further couple the interior of the anchor 120 including the coil 136 and the reinforcing arm 148 together. The cover 154 can include a sheath that can extend over the coil 136 and the reinforcing arm 148. The cover 154 can extend along the entire length of the coil 136 and the reinforcing arm 148. The cover 154 can be atraumatic to reduce the possibility of damage to the native valve.

[0183] In an example, the cover 154 can include an overmold that can be positioned over the coil 136 and the reinforcing arm 148. The overmold can be flexible to allow the anchor 120 to deflect, and can also seal and couple the coil 136 and the reinforcing arm 148 together. For example, Fig.13 A cover 154 is shown in the form of an overmold encapsulating the coil 136 and the stiffening arms 148. Various forms of overmold may be provided including a polymer overmold or another form of overmold.

[0184] The coil 136 can be configured to increase the flexibility of the anchor 120 in the radially inward direction. The flexibility of the anchor 120 can allow the anchor 120 to deflect and conform to the shape of the native valve, and can reduce the possibility of conductive interference and damage to the native valve. Enhanced deployment, connection and conformability within the native valve can be achieved. In an example, enhanced flexibility in the radially outward direction can be provided.

[0185] Figure 9-13 Features of the examples may be used alone or in combination with any other examples disclosed herein.

[0186] Fig.14 Another example of a prosthetic valve 160 is shown. In this embodiment, the prosthetic valve 160 includes a valve body 162 that surrounds an internal flow channel 164. One or more anchors 166 are pivotally coupled to the valve body 162 and are configured to pivot (rotate) about a longitudinal dimension to change the radial distance of the one or more anchors 166 from the valve body 162.

[0187] Similar to earlier embodiments, valve body 162 supports one or more prosthetic valve leaflets (e.g., Figure 2 ). The valve body 162 can include a frame and can include a sealing body that can be similar to other examples disclosed herein. For example, the outer surface 168 of the valve body 162 can include a portion of the valve body 162 that is configured to contact a portion of a native valve that can include a native valve leaflet or another portion of the valve body 162. For example, the outer surface 168 of the valve body 162 can include a sealing skirt that can be configured to seal against a portion of the native valve. Various other configurations of the valve body can be used in examples.

[0188] The longitudinal dimension of the flow channel 164 defines the direction of fluid flow through the prosthetic valve 160. The central axis 170 (at Fig.14 and 15 The valve body 162 can be centered on the central axis 170.

[0189] The anchor 166 may include a distal anchor, such as Fig.14 As shown in . For example, the distal anchors can each have a hook-shaped configuration. For example, the distal anchors can have a curved portion 172 that can be configured to hook onto the distal tip of the natural valve leaflet to anchor the prosthetic valve 160 to the implantation site. Various other configurations of the anchors 166 can be used in examples.

[0190] The anchor 166 may include an inner portion or coupling portion 174 that may pivotally couple the anchor 166 to the valve body 162. A coupling in the form of a hinge 176 or other form of coupling may couple the coupling portion 174 to the valve body 162. The hinge 176 secures the anchor to the valve body while allowing the anchor to rotate relative to the hinge (or other similar mechanism). For example, each anchor 166 may be configured to pivot about a respective axis 178 ( Fig.15 Each anchor 166 can be circumferentially spaced apart from one another, and in examples the spacing can be equal or varied.

[0191] The anchors 166 can each include a tip 182 configured to rotate about the hinge 176 .

[0192] The pivoting of the anchor 166 can change the maximum radial distance between the anchor 166 and the valve body 162. Fig.15 , the anchor 166 is shown in a top view and extends perpendicular to the outer surface 168 of the valve body 162. In such a configuration, the anchor 166 can have a maximum radial extension from the outer surface 168 of the valve body 162.

[0193] refer to Fig.16 , the anchor 166 can be pivoted about the longitudinal dimension to change the radial distance 180 between the anchor 166 and the valve body 162. Fig.16 As shown in FIG. 1 , each anchor 166 has been rotated in a counterclockwise direction to pull the tip 182 of the anchor 166 toward the outer surface 168 of the valve body 162. The maximum radial extension of the anchor 166 has been increased from Fig.15 The position shown in . The maximum radial extension of the prosthetic valve 160 has changed. The anchors 166 can continue to pivot as needed. The length 183 of each of the anchors 166 can remain constant as the anchors 166 pivot about the longitudinal dimension.

[0194] For example, Fig.17 The anchor 166 is shown continuing to rotate in a counterclockwise direction. The tip 182 can be pulled toward the outer surface 168 of the valve body 162, and the maximum radial extension of the anchor 166 has been reduced. At least a portion of the anchor 166 can extend parallel to the outer surface 168 of the valve body 162.

[0195] The anchor 166 can pivot to conform to the size of the native valve. Thus, if the size of the native valve is smaller, the maximum radial extension of the anchor 166 can be reduced, and if the size of the native valve is larger, the maximum radial extension of the anchor 166 can be increased. Thus, the angle at which the anchor 166 is positioned relative to the outer surface 168 of the valve body 162 can be varied to conform to the size of the native valve. For example, Fig.17 A representative position of the native valve leaflet 82 is shown in phantom. The tip 182 of the anchor 166 can be positioned radially outside of the native valve leaflet 82. If the native valve leaflet 82 is thicker or positioned further away from the outer surface 168 of the valve body 162, the anchor 166 can therefore be rotated further away from the outer surface 168 of the valve body 162 and can have a greater Fig.17 The larger radial extension shown in .

[0196] In an example, the anchor 166 can be configured to press the native valve leaflets to the outer surface 168 of the valve body 162. The outer surface 168 can include a sealing body, such as a sealing skirt or other forms of sealing bodies as desired. Therefore, the anchor 166 can improve the fluid seal between the valve body 162 and the native valve, and can reduce leakage, such as paravalvular leakage in the example.

[0197] In some embodiments, different numbers of anchors 166 may be used. For example, Fig.18 An example of a prosthetic valve 184 is shown, which includes a prosthetic valve 184 having a Figure 14-17 A greater number of anchors 186 are shown in the example of FIG. The plurality of anchors 186 can be circumferentially spaced from each other, and in the example the circumferential spacing can be equal or can vary.

[0198] The anchors 166, 186 can be deflected to a radial position prior to insertion and deployment into the patient's body. For example, the native valve can be sized prior to insertion of the prosthetic valve 160, 184, and thus the anchors 166, 186 can be set to a defined angle prior to insertion. The prosthetic valve 160, 184 can be crimped to a delivery device with the anchors 166, 186 disposed at a radial position and then deployed to the native valve, which deployment can include the deployment methods disclosed herein.

[0199] In an example, the anchors 166, 186 can be capable of pivoting in vivo. Once deployed, the anchors 166, 186 and / or the valve body 162 can be rotated to a maximum radial distance of the anchors 166, 186 from the valve body 162. For example, the anchors 166, 186 can be deployed from a delivery device or hooked around a native valve leaflet and then pivoted to change the radial distance from the valve body 162. The change in maximum radial distance can occur in vivo and can occur in combination with imaging of the implantation site.

[0200] In an example, the valve body 162 can be rotated relative to the native valve by the delivery device to change the maximum radial distance of the anchors 166 , 186 from the valve body 162 .

[0201] In an example, the anchors 166, 186 can be freely pivotable relative to the valve body 162. Thus, the anchors 166, 186 can be freely pivotable about the valve body 162 when deployed to conform to the size of the native valve. The anchors 166, 186 can be pivotable to allow the anchoring site to expand or contract as needed. This feature can be used to actively change the diameter of the native valve during deployment.

[0202] In an example, one or more locks can be provided that can lock the anchors 166, 186 in place relative to the valve body 162. The locks can lock the movement of the anchors 166, 186 about the longitudinal dimension. The locks can be set before the prosthetic valve 160, 184 is inserted into the patient's body. In an example, the locks can be actuated in vivo.

[0203] For example, Fig.19 A cross-sectional view of a hinge 176 that may include a lock 188 is shown. The lock 188 may include a spacer 190 and a protrusion 192, or may have another configuration for locking as desired. The lock 188 may be configured to be actuated in vivo. For example, the coupling portion 174 of the anchor 166 may pass through the hinge 176 and may be configured to pivot within the hinge 176. When the anchor 166 is pivoted to a desired position, the spacer 190 may be withdrawn from the hinge 176 to allow the protrusion 192 to contact the coupling portion 174 of the anchor 166 to lock the anchor 166 in place. The spacer 190 may be coupled to a delivery device that may be configured to withdraw the spacer 190 from the hinge 176.

[0204] For example, Fig. 20 The spacer 190 is shown having been withdrawn from the hinge 176 to lock the anchor 166 in place. The lock 188 can be locked in vivo when the anchor 166 is positioned at a desired angle relative to the valve body 162. Various other configurations of the lock can be used in examples as desired.

[0205] The anchors 166, 186 can have a variety of shapes and configurations. For example, Fig.21 An anchor 194 is shown having a distal curved portion 196 similar to Fig.14 The curved portion 172 shown in the figure, the anchor can be configured to hook on the distal tip of the prosthetic valve leaflet. The anchor 194 can include a distal anchor or a ventricular anchor. The anchor 194 can each include a proximal frame support 198, which can be configured to support the sealing body or can be used as a proximal or atrial anchor as needed. For example, the proximal frame support 198 can include an elongated arm that can extend radially outward from the valve body 200. The proximal frame support 198 can have a hook-shaped configuration and can be configured to hook on the proximal or atrial side of the natural valve to anchor the prosthetic valve 202 in place. The proximal frame support 198 can have other configurations in the example as needed. The proximal frame support 198 can be connected to a corresponding distal anchor and is configured to pivot around the longitudinal dimension with the distal anchor. In the example, the proximal frame support 198 can be integrated with the distal curved portion 196. Various other configurations of anchors 194 may be utilized as desired.

[0206] In an example, the anchors 166, 186, 194 can be configured to be axially adjusted in position. For example, the anchors 166, 186, 194 can be adjusted along respective axes about which the anchors can pivot (e.g., Fig.15 The adjustment can be made along the size of the flow channel of the prosthetic valve (e.g., Fig.15 170). The adjustment can be in the proximal direction or in the distal direction (or a combination of the proximal and distal directions) as needed. The adjustment can be performed before implantation or in vivo. In vivo adjustment can allow the axial position of the anchors 166, 186, 194 to be adjusted to account for the size of the native anatomical structure (e.g., the size or length of the native leaflets). In vivo adjustment can be used to allow capture or recapture of leaflets that the anchor has missed. For example, an anchor that missed capturing a leaflet can be advanced distally to allow the anchor to extend over the native valve leaflet, and can then be retracted proximally to allow capture of the leaflet. In an example, a combination of axial position adjustment and changes in the radial distance of the anchors 166, 186, 194 from the valve body can be utilized.

[0207] Figure 14-21 Features of the examples may be used alone or in combination with any other examples disclosed herein.

[0208] Fig. 22Another example of a prosthetic valve 210 is shown. In this embodiment, the prosthetic valve 210 includes a band 212 having an adjustable diameter, thereby allowing a sealing body 214 to be adjusted radially inward or outward. The prosthetic valve 210 may include one or more prosthetic valve leaflets (e.g., such as Figure 2 The valve body 216 may be provided with a one-way valve. The valve body 216 may surround the flow channel 218 and may include a frame that may support the prosthetic valve leaflets within the flow channel 218. The frame may include an inner frame that may be radially positioned within the sealing body 214. The valve body 216 may have a cylindrical shape or other shapes as desired.

[0209] The prosthetic valve 210 may include one or more anchors 220 that may be configured to anchor one or more prosthetic valve leaflets to the native valve. The anchors 220 may include a distal anchor that may be attached to, for example, Figure 1 The anchor 17 shown is similarly configured. For example, the anchor 220 can have a hook-shaped configuration. For example, the distal anchor can be configured to hook on the distal tip of the natural valve leaflet to anchor the prosthetic valve 210 to the implantation site. Various other configurations of the anchor 220 can be used in examples.

[0210] The sealing body 214 can be radially positioned outside of the one or more prosthetic valve leaflets and can be configured to seal a portion of a natural valve. The sealing body 214 can include a proximal portion 222 that can be coupled to a proximal portion of a valve body 216, and can include a distal portion 224 that can be coupled to a distal portion of the valve body 216 or to one or more anchors 220. The sealing body 214 includes an outer surface 226 that is configured to contact and seal the surrounding tissue of the natural valve. The sealing body 214 can include an inner surface 228 that can face away from the outer surface 226.

[0211] In an example, the sealing body 214 can be flexible and can be configured to be elastic. Thus, the sealing body 214 can be configured to move or stretch radially outward from the valve body 216 when needed. The sealing body 214 can include a sealing skirt.

[0212] The band 212 extends around the valve body 216 and around the prosthetic valve leaflets. The band 212 can be positioned radially outside the valve body 216 and the prosthetic valve leaflets. The band 212 can extend circumferentially around the sealing body 214. For example, in an example, the band 212 can be positioned radially inside the sealing body 214, or can be positioned radially outside the sealing body 214, or can be positioned inside the sealing body 214 in an example. In an example, the band 212 can form a ring. The ring can be configured to apply a force to the sealing body 214 to move the sealing body 214 radially outward or inward.

[0213] Fig.24 Shown Fig. 22 2. The band 212 may have a first end portion 230 and a second end portion 232. The first end portion 230 and the second end portion 232 may be coupled together in an example, or may be detached from each other. For example, Fig.24 As shown in , the first end portion 230 may include a coupling 234 through which the second end portion 232 may slide. The coupling 234 may be positioned at the end of the first end portion 230, and the second end portion 232 may be configured to slide through the coupling 234 to adjust the diameter 236 of the band 212. The first end portion 230 may extend along the length of the second end portion 232. The band 212 may include a loop having an end at the second end portion 232 and the first end portion 230, the first end portion being configured to overlap with the end at the second end portion 232. The band 212 may have a ring shape. Other configurations may be used in examples.

[0214] The amount by which the first end portion 230 overlaps the second end portion 232 can be varied to change the diameter 236 of the band 212. For example, a reduced amount of overlap can increase the diameter 236 of the band 212, and a greater amount of overlap can decrease the diameter 236. As the diameter 236 of the band 212 increases, the band 212 can move the sealing body 214 radially outward. As the diameter 236 of the band 212 decreases, the band 212 can move the sealing body 214 radially inward.

[0215] The second end portion 232 of the band 212 can be configured to be positioned radially outside of the first end portion 230, such as Fig.24 In an example, the second end portion 238 can be positioned radially inside the first end portion 240 of the band 242, such as Fig.25 as shown in .

[0216] The diameter 236 of the band 212 can be adjusted in a variety of ways. For example, a portion of the band 212 can be accessed by the sealing body 214 and manipulated to change the diameter 236 of the band 212. Fig.24, for example, the second end portion 232 can be grasped and slid relative to the first end portion 230 to change the diameter 236 of the band 212. The second end portion 232 can be grasped with a device such as a forceps or a part of a delivery system as needed. The coupling 234 can include a ratchet lock or other form of lock that can maintain the diameter 236 of the band 212 as needed.

[0217] In an example, an adjustment mechanism may be provided that can be configured to adjust the diameter of the belt. Fig.26 , the adjustment mechanism 244 may include a gear 246 that may be configured to rotate to adjust the amount of overlap of the first end portion 240 relative to the second end portion 238. For example, the gear 246 may include teeth that may engage a recess on the second end portion 238 and may be configured to rotate to move the second end portion 238 relative to the first end portion 240. An adjustment device comprising a meshing gear 248 may be used to engage the gear 246. For example, the meshing gear 248 may be powered or otherwise rotatable (e.g., via a pull line or another control) to rotate the meshing gear 248. The meshing gear 248 may contact the gear 246 and may rotate in a direction that increases or decreases the diameter of the band. The adjustment mechanism may be positioned at the end of the band and configured to adjust the diameter of the band. Other forms of adjustment mechanisms may be utilized as needed.

[0218] The band can be used to change the outward extent of the sealing body 214 to allow the sealing body 214 to press against the native valve and conform to the shape of the native valve. Thus, the prosthetic valve 210 can be deployed and the band 212 can be adjusted in vivo to allow the sealing body 214 to contact and apply force to the native valve. The contact between the sealing body 214 and the native valve can reduce fluid flow or leakage around the prosthetic valve 210. The band can be adjusted in vivo to account for different sizes or shapes of the native valve.

[0219] In an example, the diameter of the band can be adjusted prior to insertion into the patient's body. For example, the size of the native valve can be imaged and the band can be adjusted to conform to the size of the native valve.

[0220] Figure 22-26 Features of the examples may be used alone or in combination with any other examples disclosed herein.

[0221] Fig. 27 Another example of a prosthetic valve 260 is shown including a valve frame 262 surrounding a flow channel 264. A sealing skirt 266 is positioned radially outward from the valve frame 262, wherein the sealing skirt 266 is in tension and adapted to deflect to conform to the shape of the native valve. Fig.28A spacing (eg, gap) 268 between the sealing skirt 266 and the valve frame 262 is shown.

[0222] refer to Fig. 27 , the valve frame 262 can support one or more prosthetic valve leaflets (e.g., such as Figure 2 ), the one or more prosthetic valve leaflets may extend radially inward from the valve frame 262 and may be positioned within the flow channel 264. The valve frame 262 may support the prosthetic valve leaflets within the flow channel 264. The valve frame 262 may be positioned radially within the sealing skirt 266. The valve frame 262 may have a cylindrical shape or other shapes as desired.

[0223] The valve frame 262 can be configured to Figures 1 to 3 The inner frame 18 discussed above can be compressed and expanded in a similar manner. For example, the valve frame 262 can be expanded radially outward, and the length of the valve frame 262 can be reduced (e.g., as shown in FIG. Fig.28 The valve frame 262 is Fig. 27 can be in a compressed or unexpanded configuration and in Fig.28 Thus, the diameter of the valve frame 262 can be expanded radially outward, and the length of the valve frame 262 can be reduced, such as Fig.28 as shown in .

[0224] The sealing skirt 266 can be radially positioned outside of one or more prosthetic valve leaflets and the valve frame 262, and can be configured to seal a portion of the natural valve. The sealing skirt 266 can surround the valve frame 262. The sealing skirt 266 can include a proximal portion 270 and a distal portion 272. The sealing skirt 266 can be suspended between the proximal portion 270 and the distal portion 272, and can be maintained by the space 268 between the sealing skirt 266 and the valve frame 262.

[0225] The prosthetic valve 260 may include one or more proximal tensioning bodies 274 and may include one or more distal tensioning bodies 276. The proximal tensioning bodies 274 may be positioned at a proximal portion of the prosthetic valve 260, and the distal tensioning bodies 276 may be positioned at a distal portion of the prosthetic valve 260. A proximal portion 270 of the sealing skirt 266 including a proximal end of the sealing skirt 266 may be coupled to the proximal tensioning bodies 274. A distal portion 272 of the sealing skirt 266 including a distal end of the sealing skirt 266 may be coupled to the distal tensioning bodies 276.

[0226] The proximal tensioning body 274 may have various forms. Figure 27-29As shown in , the proximal tensioning body 274 can include an arm having a first end 278 coupled to a proximal portion of the valve frame 262 and a second end 280 configured to extend radially outward from the first end 278. The proximal tensioning body 274 can extend radially outward from the proximal portion of the valve frame 262. Similarly, the distal tensioning body 276 can include an arm having a first end 282 coupled to a distal portion of the valve frame 262 and a second end 284 configured to extend radially outward from the first end 282. The distal tensioning body 276 can extend radially outward from the distal portion of the valve frame 262. Reference Fig.29 , the arms of the proximal tensioning body 274 and the distal tensioning body can be circumferentially spaced from one another and can extend radially outward from the flow channel 264. The spacing can be circumferentially equidistant from one another, or varying spacing can be provided.

[0227] The sealing skirt 266 can be tensioned by the proximal tensioning body 274 and the distal tensioning body 276. For example, referring to Fig.28 and 29 When the valve frame 262 is expanded, the sealing skirt 266 can be tensioned and kept suspended between the proximal tensioning body 274 and the distal tensioning body 276. The central portion of the sealing skirt 266 can be unconnected and without a frame, and can be deflected inwardly to conform to the shape of the native valve. For example, the sealing skirt 266 can be elastic and configured to deflect inwardly to conform to the shape of the native valve.

[0228] For example, Fig.30 The prosthetic valve 260 is shown deployed to the native valve 80. The tensioning sealing skirt 266 deflects radially inward to conform to the shape of the native valve 80 and, in particular, the position of the native valve leaflets 82. The sealing skirt 266 can form a seal with the native valve 80 to reduce fluid flow outside of the flow channel 264 (e.g., paravalvular leakage).

[0229] like Fig.30 As shown in , the distal tension body 276 in the example can contain a distal or ventricular anchor for the prosthetic valve 260. The proximal tension body 274 in the example can contain a proximal or atrial anchor for the prosthetic valve 260. Thus, the distal tension body 276 and the proximal tension body 274 can anchor the prosthetic valve 260 in place and resist proximal and distal movement, or atrial and ventricular movement.

[0230] In examples, the proximal or distal tensioning body may have other forms. Fig.31 , the proximal tensioning body may include a ring 290. The ring 290 may be compressible and biased to expand outwardly or as Fig.31The ring 290 may support the proximal portion 292 of the sealing skirt 294. The distal tensioning body may include a ring 296. The ring 296 may similarly be compressible and biased to expand outwardly or into a position such as Fig.31 The shapes shown in .

[0231] The sealing skirt 294 can be tensioned by the proximal ring 290 and the distal ring 296. For example, Fig.32 As shown in the cross-sectional view of FIG. 3 , the sealing skirt 294 can be in a tensioned state and positioned in a space 298 between the sealing skirt 294 and the valve frame 300. The sealing skirt 294 can be configured to Fig.30 The sealing skirt 266 shown in FIG. 2 deflects inwardly in a similar manner.

[0232] Fig.33 A prosthetic valve 301 is shown in which a sealing skirt 302 is supported by a plurality of wires 304. The wires 304 can extend along the sealing skirt 302. The sealing skirt 302 can be positioned radially outward from a valve frame 306, with a space between the sealing skirt 302 and the valve frame 306, the sealing skirt 302 being in tension and configured to deflect to conform to the shape of a native valve. The plurality of wires 304 can extend axially and can be circumferentially spaced apart from each other around the valve frame 306. The plurality of wires 304 can be configured to deflect inwardly with the sealing skirt 302.

[0233] Fig.34 An example of a prosthetic valve 310 is shown, wherein a sealing skirt 312 is supported by a plurality of wires 314. The wires 314 can extend along the sealing skirt 312. The sealing skirt 312 can be positioned radially outward from a valve frame 316, wherein there is a space between the sealing skirt 312 and the valve frame 316, and the sealing skirt 312 is in a tensioned state and is configured to deflect to conform to the shape of a natural valve. The plurality of wires 314 can each extend circumferentially and can be axially spaced apart from each other. The plurality of wires 314 can be configured to deflect inwardly with the sealing skirt 312.

[0234] Fig.35 An example of a prosthetic valve 320 is shown, wherein a sealing skirt 322 is supported by a plurality of wires 324. The wires 324 may extend along the sealing skirt 322. The sealing skirt 322 may be positioned radially outward from a valve frame 326, wherein there is a space between the sealing skirt 322 and the valve frame 326, the sealing skirt 322 being in tension and configured to deflect to conform to the shape of a natural valve. The plurality of wires 324 may each extend axially at an angle relative to the central axis of the prosthetic valve 320. The plurality of wires 324 may be circumferentially spaced apart from each other around the valve frame 326. The plurality of wires 324 may be configured to deflect inwardly with the sealing skirt 322.

[0235] Fig.36 An example of a prosthetic valve 330 is shown in which the proximal tensioning body includes a ring 332 or a similar annular member. The distal portion of the sealing skirt 334 can be coupled to a portion of the valve frame 336 or to one or more of the distal anchors 338. The sealing skirt 334 can be positioned radially outward from the valve frame 336 with a space between the sealing skirt 334 and the valve frame 336, the sealing skirt 334 being in a tensioned state and configured to deflect to conform to the shape of the native valve. The ring 332 can be coupled to the distal portion of the valve frame 336. Fig.31 The ring 290 shown in FIG. 2 can be configured in a similar manner. For example, Fig.37 A top view of a ring 332 is shown, which may have overlapping end portions.

[0236] In an example, the sealing skirt may include a pocket. A ring or other form of tensioning member may be positioned within the pocket. For example, Fig.38 A cross-sectional view of a prosthetic valve 340 is shown that includes a sealing skirt 344 positioned radially outward from a valve frame 346 and including a pocket 348 extending around the circumference of the valve 340. A ring 332 can be positioned within the pocket 348 and configured to support the sealing skirt 344. The ring 332 can include a proximal tensioning body configured to tension the sealing skirt 344.

[0237] The valve frame 346 may be associated with Fig. 27 346 can be configured in a similar manner to the valve frame 262 discussed above. The valve frame 346 can surround a flow channel 350, wherein one or more prosthetic valve leaflets can be coupled to the valve frame 346 and can extend radially inward from the valve frame 346 and be positioned within the flow channel 350. The prosthetic valve leaflets can extend radially inward from the valve frame 346 and can be positioned within the flow channel 350. The valve frame 346 can support the prosthetic valve leaflets within the flow channel 350.

[0238] One or more distal anchors 352 can be coupled to the distal portion of the valve frame 346. The distal anchor 352 can be configured in a manner similar to the distal anchor 17 discussed with respect to 1. For example, the distal anchor 352 can have a hook-shaped configuration. For example, the distal anchor can be configured to hook on the distal tip of the natural valve leaflet to anchor the prosthetic valve 340 to the implantation site. Various other configurations of the anchor 352 can be used in examples.

[0239] The sealing skirt 344 can include a distal portion 354 coupled to one or more distal anchors 352 and a proximal portion 356 containing the pocket 348. The proximal portion 356 of the sealing skirt 344 can further be coupled to a proximal portion of the valve frame 346.

[0240] The bag 348 may include overlapping material that seals the skirt 344. For example, Fig.38 , the bag 348 may include a first portion 358 or proximal portion and a second portion 360 or distal portion extending along the length of the first portion 358. The first portion 358 and the second portion 360 of the bag 348 may extend parallel to each other. The space between the first portion 358 and the second portion 360 may include a cavity for receiving the ring 332. The first portion 358, the second portion 360, and the ring 332 may each extend circumferentially around the valve frame 346 so that the cavity and the bag 348 have an annular shape around the valve frame 346. The bag 348 may be used to position the ring 332 at a desired position relative to the sealing skirt 344.

[0241] The sealing skirt 344 can be in a tensioned state and configured to deflect to conform to the shape of the native valve.

[0242] In an example, the distal portion of the sealing skirt can be coupled to one or more slidable couplers, wherein each slidable coupler is configured to slide relative to one or more anchors. Fig.39 A prosthetic valve 361 is shown including one or more slidable couplers 362. The one or more slidable couplers 362 can couple a distal portion 354 of the sealing skirt 344 to one or more distal anchors 352 and can be configured to allow the distal portion 354 of the sealing skirt 344 to slide relative to the distal anchors 352.

[0243] The sealing skirt 344 may be Fig.38 The sealing skirt 344 discussed above may be configured in a similar manner and may or may not include the sealing skirt 344 described above. Fig.38 The sealing skirt 344 can be positioned radially outward from the valve frame 346. The sealing skirt 344 can be in a tensioned state and configured to deflect to conform to the shape of the native valve. The valve frame 346 can be in contact with the valve frame 346. Fig.38 The valve frame 346 discussed above can be configured in a similar manner. The valve frame 346 can surround the flow channel. The valve frame 346 can support one or more prosthetic valve leaflets that can extend radially inward from the valve frame 346 and can be positioned within the flow channel.

[0244] The distal anchors 352 can be configured in a similar manner to the distal anchors 352 discussed with respect to 38. The distal anchors 352 can be configured to anchor the prosthetic valve leaflets to the native valve. Each of the distal anchors 352 can include an elongated arm. The elongated arm can extend radially outward to a tip 363 of the elongated arm.

[0245] refer to Fig.40, each of the slidable couplers 362 can include a ring. The ring can surround a corresponding one of the one or more anchors 352 and can be configured to slide along the one or more anchors 352. In an example, the slidable coupler 362 can be configured to slide in a radially inward direction along the length of the one or more anchors 352, and can be configured to slide in a radially outward direction along the length of the one or more anchors 352.

[0246] For example, the distal anchor 352 can include an elongated arm, and the slidable connector 362 can be configured to slide along the length of the elongated arm. For example, the slidable connector 362 can slide away from the tip 363 relative to the tip 363 of the elongated arm, or slide radially inward, such as Fig.40 The slidable coupler 362 can slide away from the tip 363 to increase the size of the protrusion 364 of the elongated arm, which is positioned between the slidable coupler 362 and the tip 363. The protrusion 364 can overlap the distal tip of the native valve leaflet. The size of the protrusion 364 can be increased to conform to the shape of the native valve.

[0247] For example, Fig.40 , the leaflet 82 can have a greater length or thickness, which can allow the slidable coupler 362 to slide radially inward and away from the tip 363. Therefore, the size of the protrusion 364 can increase to accommodate the size of the leaflet 82 located between the tip 363 and the sealing skirt 344. Therefore, the distal portion 354 of the sealing skirt 344 can slide relative to the anchor 352. The distal portion 354 of the sealing skirt 344 can slide radially inward and can contact the leaflet 82 to form a seal with the leaflet 82.

[0248] Thus, the movement of the slidable coupling 362 can accommodate various configurations of the native valve to allow sealing in situations where the native valve has a larger size, such as Fig.40 In an example, if the native valve has a relatively small size, the slidable connector 362 can slide radially inward to a smaller distance. For example, Fig.41 The slidable connector 362 is shown sliding radially inward to a position smaller than Fig.40 Such a configuration may be achieved by having a leaflet 82 having a length or size greater than that of the leaflet 82. Fig.40 Thus, the slidable connector 362 can accommodate native valves of various sizes.

[0249] In an example, the slidable coupling 362 can be configured to slide radially outward. Movement of the slidable coupling 362 can allow the sealing skirt 344 to be pulled radially outward when the size of the native valve is small.

[0250] The prosthetic valve 361 can be deployed to the natural valve, and the slidable coupling 362 can automatically slide to conform to the shape of the natural valve. For example, the slidable coupling 362 can slide inward or outward according to the shape of the natural valve.

[0251] In an example, the slidable coupling 362 can be controlled during or after deployment to adjust the position of the slidable coupling 362. This adjustment can occur in vivo. The deployment can be imaged and the slidable coupling 362 can be slid to account for the size and shape of the native valve. In an example, the slidable coupling 362 can be adjusted before insertion into the patient's body.

[0252] In an example, the slidable coupling 362 may have a form other than a ring. For example, a slide rail, a magnetic coupling, or other forms of slidable coupling may be utilized as desired.

[0253] Fig.42 A prosthetic valve 370 is shown including one or more anchors 372 that each include a coil 374. The coil 374 can form an elongated arm extending radially outward from a valve frame 376 of the prosthetic valve 370.

[0254] Each coil 374 may include a first portion or inner portion 378 coupled to a valve frame 376 and a second portion or outer portion 380 extending radially outward from the inner portion 378. Each coil 374 may extend from a proximal portion of a valve body including the valve frame 376. The coil 374 may include a flexible elongated arm configured to deflect to conform to the shape of a native valve. Fig.43 As shown in the top schematic view of FIG, the anchors 372 can be circumferentially spaced apart from one another and can each extend radially outward from the valve frame 376.

[0255] In an example, the coil 374 can have equal flexibility along the length of the coil 374, or can include one or more portions that can have different flexibility. For example, the coil 374 can have a portion 382 that can have increased flexibility relative to a radially outward portion 384 of the coil 374 and relative to a radially inward portion 386 of the coil 374. Thus, the coil 374 can be configured to deflect inwardly and / or outwardly about the portion 382 as desired.

[0256] In an example, each anchor 372 may be associated with Fig.11 and 12 The anchor 120 discussed above is similarly configured. For example, the anchor 372 may include one or more coil portions, reinforcing arms, and / or covers, which may be configured in conjunction with the anchor 120 discussed above. Fig.11 and 12The anchor 120 discussed above is similarly configured. In an example, the anchor 372 may include only the coil 374 .

[0257] The anchor 372 can include a proximal tensioning body that can be coupled to the sealing skirt 388 and can tension the sealing skirt 388. For example, the portion 382 of the coil 374 can be coupled to the proximal portion of the sealing skirt 388 and can support the sealing skirt 388 to seal with the native valve. The sealing skirt 388 can be positioned radially outward from the valve frame 376, with a space between the sealing skirt 388 and the valve frame 376, the sealing skirt 388 being in a tensioned state and configured to deflect to conform to the shape of the native valve. The distal end of the sealing skirt 388 can be coupled to the distal anchor 390 or another portion of the prosthetic valve 370 as desired.

[0258] Fig.43 A top schematic view of a prosthetic valve 370 is shown, illustrating one exemplary arrangement of circumferentially spaced anchors 372 .

[0259] Anchor 372 may include a proximal or atrial anchor that may anchor prosthetic valve 370 in the atrium of the heart. Fig.44 A prosthetic valve 370 is shown deployed to a native valve 80 and anchored to the native valve leaflets 82. The anchor 372 can extend proximally and can contact the wall of the atrium or a portion of the native valve on the atrial side of the valve. The anchor 372 can be flexible to reduce the possibility of damage or conductive interference to the native valve.

[0260] In an example, the distal anchor 390 can be connected to the Figure 1 The distal anchor 17 discussed above anchors the prosthetic valve 370 to the native valve in a similar manner. The distal anchor 390 may comprise a hook-shaped anchor positioned at the distal portion of the valve body. The sealing skirt 388 may seal against the native valve to reduce flow outside the flow channel of the valve 370.

[0261] Fig.45 An example of a prosthetic valve 400 is shown that includes one or more anchors 402 configured to secure prosthetic valve leaflets to a native valve, the one or more anchors 402 comprising a generally T-bar 404 shaped structure.

[0262] The prosthetic valve 400 can include a valve frame 406 surrounding a flow channel 408. One or more prosthetic valve leaflets can be positioned within the flow channel 408 and can be supported by the valve frame 406. A sealing skirt 410 can be positioned radially outside of the valve frame 406 and can be supported by the anchor 402. For example, the sealing skirt 410 can have a proximal portion and a distal portion, and the anchor 402 can include a proximal tensioning body coupled to the proximal portion of the sealing skirt 410 and configured to cause tensioning of the sealing skirt 410.

[0263] refer to Fig.46 , each T-bar 404 can include a crossbar 412 and a rod 414. The rod 414 can extend the crossbar 412 radially outward from the valve frame 406. Each rod 414 can be coupled to a proximal portion of the valve frame 406. The crossbar 412 can be positioned radially outside of the rod 414. The crossbar 412 can extend laterally relative to the rod 414. The crossbar 412 can include a support member that can support the sealing skirt 410 under tension.

[0264] refer to Fig.47 , each T-bar 404 can be circumferentially spaced apart from each other around the valve frame 406. The crossbars 412 of the plurality of anchors 402 can form a ring extending circumferentially around the prosthetic valve. The segmented flange extending circumferentially around the prosthetic valve can be formed by the crossbars 412 of the plurality of anchors 402. Each T-bar 404 can be positioned at a proximal portion of the valve frame 406 and can extend radially outward from the proximal portion of the valve frame.

[0265] In an example, each T-bar 404 can be configured to deflect radially inward. For example, Fig.48 A top view of a T-bar 404 is shown, wherein the arms of a crossbar 412 extend circumferentially outward relative to a rod 414. The crossbar 412 may include a central portion 413 coupled to the rod 414 and a first arm 415 and a second arm 417 each extending outward from the central portion 413. The first arm 415 and the second arm 417 may extend circumferentially outward. In an example, for example, the arms 415, 417 of the crossbar 412 may be deflected inwardly toward the rod 414, such as Fig.49 as shown in .

[0266] The rod 414 may include a linearly extending rod 414, or in an example, may include an undulating portion. Fig.50 A variation of a rod 416 is shown that includes undulations configured to provide flexibility to the rod 416. The undulations may increase the flexibility of the rod 416. Thus, the flexibility of the T-shaped rod may be increased.

[0267] The anchor 402 can include a proximal or atrial anchor that can support the prosthetic valve 400 within the native valve. The anchor 402 can be configured to be flexible to allow the anchor 402 to conform to the shape of the native valve.

[0268] In an example, the prosthetic valve 400 may include one or more distal anchors 418. The distal anchor 418 may be positioned at a distal portion of the valve frame 406. The distal anchor 418 may be configured in a manner similar to the distal anchor discussed with respect to 1. For example, the distal anchor 418 may be configured to hook onto the distal tip of the native valve leaflet to anchor the distal anchor 418 to the native valve. In an example, the distal anchor 418 may be coupled to a distal portion of the sealing skirt 410, and the sealing skirt 410 may be tensioned.

[0269] In an example, the distal anchor 418 can be positioned circumferentially between two proximal anchors comprising adjacent T-bars 404. For example, Fig.51 Such a configuration of the distal anchor 418 and T-bar 404 is shown. The sealing skirt 410 can extend between the distal anchor 418 and the valve frame 406, and can extend outward from the circumferentially adjacent T-bar 404. Thus, once the distal anchor 418 misses capturing a leaflet, the anchor can be positioned inside the outer extent of the T-bar 404. Thus, the sealing skirt 410 covering the T-bar 404 can provide a seal at portions of the native valve that have missed capturing a native leaflet.

[0270] For example, Fig.52 A side perspective view is shown showing the distal anchors 418 positioned on circumferentially adjacent T-bars 404 .

[0271] Relative to Figure 27-52 The disclosed prosthetic valves may comprise a single frame prosthetic valve, or may have another configuration as desired. Figure 27-52 Features of the examples may be used alone or in combination with any other examples disclosed herein.

[0272] Fig.53 An example of a prosthetic valve 430 is shown in which the sealing skirt 432 forms a disk-shaped structure that extends along the length of each of the elongated anchor arms 434. The disk-shaped structure can be continuous around the circumference and can extend between adjacent anchor arms 434.

[0273] The prosthetic valve 430 may include a valve body 431 (e.g., a valve body 432) supporting one or more prosthetic valve leaflets. Figure 2 As shown in FIG. 4 ). The valve body 431 may include: Fig.53The frame shown in or may have another configuration as desired. A plurality of distal anchors may be provided in the form of anchor arms 434.

[0274] The anchor arms 434 can include elongated arms each having a first end 433 coupled to the valve body 431 and extending radially outward along a length from the first end 433 to a tip 435 of the corresponding elongated arm. Each elongated anchor arm 434 can be configured to hook onto a distal tip of a native valve leaflet to anchor one or more prosthetic valve leaflets to the native valve. Thus, the sealing skirt 432 can extend along the anchor arms 434 and can be positioned radially outside of the native valve leaflets. For example, Fig.54 The location of the sealing skirt 432 radially outward of the native valve leaflets is shown.

[0275] In an example, the sealing skirt 432 can be coextensive with each of the elongated anchor arms 434. Fig.53 and 54 The sealing skirt 432 shown in FIG. 4 can fit closely along the elongated anchor arms 434 and extend along the length of the arms 434. Each elongated anchor arm 434 can have a curved portion 437, and the disc formed by the sealing skirt 432 can extend along the curved portion 437.

[0276] The radially outward extent of the sealing skirt 432 can vary. In an example, the sealing skirt 432 can extend from the first end 433 of the anchor arm 434 to the tip 435 of each anchor arm 434. In an example, a lesser extent (e.g., along only a portion of the anchor arm 434) can be provided. The sealing skirt 432 can also extend along the anchor arm 434 so that the sealing skirt 432 is radially positioned outside of the native valve leaflets.

[0277] The sealing skirt 432 may comprise a disk having a convex curvature, such as Fig.53 The sealing skirt 432 may extend circumferentially around the entire valve body 431 and may form a continuous disk around the valve body 431 .

[0278] In an example, the sealing skirt 432 can be coextensive with the frame of the valve body 431. For example, Fig.53 As shown in , the sealing skirt 432 can extend proximally along the frame to the proximal portion and proximal end of the frame. The sealing skirt 432 can continue distally along the frame and can be continuous with the portion of the sealing skirt 432 extending along the anchor arm 434. In an example, the prosthetic valve can include a single frame prosthetic valve.

[0279] Based on the sealing skirt 432 extending along the anchor arm 434 and forming a disc configuration, an improved seal can be produced. A smaller crimp profile can also be provided.

[0280] The frame may have a shape including a shoulder or hourglass shape to reduce the likelihood of the prosthetic valve migrating into the ventricle. The hourglass shape is also advantageous because the prosthetic leaflets conform to the inner wall of the hourglass, thereby reducing any gaps between the prosthetic leaflets and the frame when the prosthetic leaflets are in an open configuration that allows blood to pass through the prosthetic valve 430. The elimination of gaps reduces the amount of stagnant blood and thereby reduces the likelihood of thrombus formation.

[0281] In an example, the ventricular cords may be severed to allow the disc to extend around the native valve leaflets. The cords may be severed prior to deployment of the prosthetic valve to reduce the likelihood of interference between the cords and the sealing skirt 432. In an example, the sealing skirt 432 may include one or more slits to allow the prosthetic valve to be deployed without severing the cords. In an example, the cords may be positioned within one or more of the slits when deployed.

[0282] Fig.53 and 54 Features of the examples may be used alone or in combination with any other examples disclosed herein.

[0283] Fig.55A A cross-sectional view of an anchor 440 that can be used in examples herein is shown. The anchor 440 can include a hinge 442 that can be configured to allow the anchor 440 to deflect radially.

[0284] Anchor 440 can be configured to be used with any example of a prosthetic valve disclosed herein or with another form of a prosthetic valve. Anchor 440 can include an inward portion or coupling portion 444 that can be coupled to a valve body 446. Valve body 446 can be configured similarly to any example of a valve body disclosed herein, or can have another configuration in an example. Valve body 446 can support one or more prosthetic valve leaflets. Anchor 440 can be coupled to a distal portion 448 of valve body 446 in an example, or can be located at another position in an example as desired.

[0285] In an example, the anchor 440 can include an elongated arm. In an example, the coupling portion 444 of the anchor 440 can be curved and can have a convex curvature in the distal direction. The coupling portion 444 can extend distally. The coupling portion 444 can be coupled to the tip portion 450 of the anchor 440. The coupling portion 444 can extend the tip portion 450 of the anchor 440 radially outward to increase the radially outward position of the tip portion 450. In an example, the coupling portion 444 can have other configurations as desired.

[0286] When the anchor 440 is deployed, the tip portion 450 of the anchor 440 can extend proximally. In an example, the tip portion 450 can extend linearly from the junction 443 with the coupling portion 444. The tip portion 450 can extend linearly in the proximal direction to the tip 452 of the anchor 440. The tip 452 can be axially aligned with the middle portion 454 of the valve body 446, or can be in another position as desired in an example.

[0287] The hinge 442 can be located at the junction 443 of the tip portion 450 and the coupling portion 444, or can be located at another location as desired. In an example, the hinge 442 can be located proximal to the tip portion 450 and closer to the tip portion 450. Fig.55A 450. The portion of the anchor 440 positioned proximal or external to the hinge 442 can include the pivoting portion of the anchor 440, and the portion of the anchor 440 positioned distal or internal to the hinge can include the static portion of the anchor 440. In an example, the hinge 442 can be positioned on the coupling portion 444.

[0288] Hinge 442 can be configured to allow the pivoting portion of anchor 440 to deflect radially inwardly, such as Fig.55B Hinge 442 can increase the flexibility of anchor 440 in a radially inward direction. Hinge 442 can be configured to pivot about an axis extending transversely relative to the longitudinal axis of the prosthetic valve.

[0289] In an example, hinge 442 can be configured to resist radially outward deflection of anchor 440. For example, hinge 442 can include a one-way or unidirectional hinge 442 that can allow radially inward movement and resist radially outward movement. In an example, hinge can allow anchor 440 to deflect radially outward.

[0290] In an example, the anchor 440 can be configured to be in a hook configuration. The anchor 440 can be configured to extend over the distal end or distal tip of the native valve leaflet for anchoring. The tip portion 450 can be positioned radially outside of the native valve leaflet in the hook configuration.

[0291] In an example, hinge 442 can include a joint or a connecting rod. For example, hinge 442 can include a mechanical bearing hinge, such as Fig.55A and 55B. The mechanical bearing hinge may include multiple components configured to rotate or otherwise move relative to each other to allow the hinge to operate. The mechanical bearing hinge may include an axis about which the mechanical bearing hinge pivots. In an example, the mechanical bearing hinge may be formed by a connector such as suture or fabric that connects the tip portion 450 to the coupling portion 444. In an example, a suture loop may be used as the axis. In an example, the hinge may include a living hinge 456 such as Fig.56 The living hinge 456 may include a thinner or weaker portion of material that includes the anchor 458, about which the anchor 458 may deflect. The thinner or weaker portion may be on a radially facing surface of the anchor 458 (e.g., Fig.56 ), or may be on one or more side surfaces (e.g., circumferentially facing surfaces) of the anchor 458.

[0292] In an example, the hinge can be spring biased to a radially outward position. In an example, the spring bias can be overcome with a radially inward force. In an example, the spring bias can be generated by a portion of the hinge that includes a spring. The material (e.g., a shape memory material or other form of material) that includes the hinge can include a spring bias material that can be biased to a radially outward position.

[0293] The hinges disclosed herein can allow the anchor to pivot to allow the anchor to better conform to the implantation site when implanted. For example, the anchor can be configured to deflect radially inward to accommodate the shape of the native heart valve. The radial pressure on the implantation site can be reduced. The likelihood of conductive interference with the native anatomical structure can be reduced. For example, the force on the conductive structure of the heart (e.g., the AV node) or the heart valve annulus can be reduced.

[0294] In an example, the hinge disclosed herein can be configured to allow the anchor to capture or recapture a native valve leaflet that the anchor has missed capturing. In an example, the capture or recapture can occur during the deployment sequence of the prosthetic valve. In an example, the capture or recapture can occur after the deployment sequence.

[0295] Capture or recapture of the native valve leaflet can occur in response to movement of the native valve leaflet. In an example, this movement can include contraction movement of the native valve leaflet. In an example, the contraction movement can be used for deployment to the mitral valve or tricuspid valve. The hinge can be configured to allow the corresponding anchor to deflect radially inward in response to a radially inward force of the native valve leaflet.

[0296] For example, Figure 57-62Shown is a deployment sequence for a prosthetic valve 460 that utilizes one or more of hinges 442. A prosthetic valve that utilizes one of living hinges 456 may operate in a similar manner.

[0297] refer to Fig.62 The prosthetic valve 460 can be configured similarly to any example of a prosthetic valve or any other form of a prosthetic valve disclosed herein. For example, the prosthetic valve 460 can include a valve similar to that described with respect to Figure 1-8 The prosthetic valve 460 may include a valve body 446, which may include an inner valve body 447 or an inner frame in an example. The valve body 446 may include a proximal portion 449 and a distal portion 448, and the anchor 440 may be coupled to the distal portion 448 of the valve body 446. One or more anchors 440 (a plurality of anchors 440a, b are shown in FIG. 4 ) may be used. Fig.62 ). The anchors 440 can extend radially outward from the valve body 446. The anchors 440 can be circumferentially spaced apart from each other.

[0298] The valve body 446 can include a sealing body 466 positioned radially outside of the inner valve body 447. The sealing body 466 can include a distal portion 453 and a proximal portion 455. The proximal portion 457 of the inner valve body 447 can be coupled to the proximal portion 455 of the sealing body 466. The anchor 440 can be coupled to the distal portion 459 of the inner valve body 447. The inner valve body 447 can include an inner frame, and the sealing body 466 can include an outer frame. In an example, the sealing skirt can be positioned on the outer frame.

[0299] The distal portion 459 of the inner valve body 447 can be separated from the distal portion 453 of the sealing body 466 by a gap 461.

[0300] refer to Fig.57 , the prosthetic valve 460 is shown in a compressed or crimped configuration within a capsule 462 of a delivery device. Fig.57 In the configuration shown in FIG. 4 , anchors 440a, b can each be configured similarly to anchor 440, which is shown in an elongated or extended configuration within capsule 462. Prosthetic valve 460 can be in a compressed or crimped configuration to access an implantation site.

[0301] The anchors 440a, b can be released from the capsule 462 in the manner disclosed herein. Fig.58, capsule 462 can be retracted and anchors 440a, b can be allowed to expand radially outward. Anchor 440b can capture the natural valve leaflet 464b and be positioned radially outside thereof. However, anchor 440a may miss capturing or fail to capture the natural valve leaflet 464a and can be positioned radially inside the natural valve leaflet 464a. Hinge 442 on anchor 440a can be used to allow capture or recapture of the natural valve leaflet 464a. In an example, the contraction movement of leaflet 464a can pivot hinge 442 to allow capture or recapture of the natural valve leaflet 464a.

[0302] The movement of anchor 440a can occur due to the radial inward movement of leaflet 464a under the contraction closing movement of leaflet 464a. Hinge 442 can pivot inward to allow anchor 440a to be positioned radially outside of leaflet 464a. Leaflet 464a can pass through the tip of anchor 440a in a radial inward direction to be positioned radially inside anchor 440a. Hinge 442 can pivot to accommodate the movement of leaflet 464a.

[0303] For example, Fig.59 –61 shows such movement of leaflet 464a. Fig.59 , leaflets 464a are shown positioned radially outward of anchor 440a. Prosthetic valve 460 can be in the process of deployment and can be partially retained in a radially inward compressed configuration. Compression of prosthetic valve 460, and specifically the outer frame or sealing body 466 of prosthetic valve 460, can increase the gap 468 between anchor 440a and the body of prosthetic valve 460, which can increase the ability of anchor 440a to rotate radially inward. The space for the tip of anchor 440a to rotate can be increased.

[0304] Once deployed, leaflets 464a, b can move according to diastolic and systolic movements. Leaflet 464b can be restrained from moving radially outward by anchor 440b during diastolic movement. However, leaflet 464b can be able to move radially inward during systolic movement. Leaflet 464a can move radially inward during systolic movement. Inward movement of leaflet 464a can cause hinge 442 on anchor 440a to pivot radially inward. For example, leaflet 464a can move radially inward of anchor 440a, as shown in FIG. Fig.60 In an example, the leaflet 464a can be moved radially inward by the tip 452 of the anchor 440a.

[0305] The configuration of the hinge 442 on the anchor 440a can hinder radial outward movement of the leaflet 464a during diastole, and accordingly the leaflet 464a can be captured by the anchor 440a, as shown. Fig.61 as shown in .

[0306] The prosthetic valve 460 may be Fig.62 The anchors 440a,b can capture the respective leaflets 464a,b.

[0307] In an example, the anchors 440a, b can be configured to deflect radially outward. For example, the hinge utilized can be configured to allow radial outward movement. Radially outward movement can increase the flexibility and pliability of the anchors 440a, b when implanted. Other configurations can be used in an example.

[0308] In an example, the anchor disclosed herein can include a visual indicator under medical imaging of whether a leaflet has been captured. Radially inward movement of the anchor can include an indication that leaflet capture has not occurred. The medical imaging can include ultrasound (e.g., echocardiography) or fluoroscopy, a combination of ultrasound and fluoroscopy, or other forms of medical imaging. In an example, the anchor can include a fluoroscopic marker. The anchor can be visualized to determine whether leaflet capture has occurred or a leaflet has been missed.

[0309] Fig.55A The features of the example of -62 may be used alone or in combination with any other example disclosed herein.

[0310] Figure 63-67 480, such as Fig.63 . The inner frame 480 can be configured to support one or more prosthetic valve leaflets, similar to other examples of inner frames disclosed herein. The inner frame 480 can include a proximal portion 481 and a distal portion 483. For example, the frame can include an outer frame 482, such as Fig.64 as shown in .

[0311] The outer frame 482 may include one or more anchors 484 that may be configured to anchor the frame to the implantation site. One or more anchors 484 may be coupled to the outer frame 482 and may be configured to be radially positioned outside of one or more leaflets of the native valve to anchor to the native valve. Anchors 484 may include anchors having a hook configuration, or may include other forms of anchors in an example.

[0312] The outer frame 482 may include a proximal portion 486 and a distal portion 488. In an example, the anchor 484 may be positioned at the distal portion 488 of the outer frame 482. The outer frame 482 may include a plurality of struts having a lattice structure. In an example, the struts of the outer frame 482 may form a plurality of distal vertices 490. The anchor 484 may extend distally from the vertices 490. Other locations may be used in an example.

[0313] Each anchor 484 may include a coupling portion 493 and a tip portion 495. The coupling portion 493 may be coupled to the outer frame 482, and the tip portion 495 may be configured to extend proximally from the coupling portion 493. The coupling portion 493 may be coupled to the distal portion 488 of the outer frame 482. In an example, the coupling portion 493 may be coupled to a corresponding distal vertex of the distal vertices 490. The coupling portion 493 may have a convex curvature in the distal direction (e.g., Fig.64 ), or may have another configuration in an example as desired. In an example, the tip portion 495 may extend linearly from the coupling portion 493.

[0314] Fig.65 A perspective view of the inner frame 480 coupled to the outer frame 482 is shown. The proximal portion 481 of the inner frame 480 can be coupled to the proximal portion 486 of the outer frame 482.

[0315] Fig.66 A side view of an inner frame 480 coupled to an outer frame 482 is shown. The outer frame 482 can be positioned radially outward from the inner frame 480 and can surround the inner frame 480. In an example, a distal portion 483 of the inner frame 480 can be separated from a distal portion 488 of the outer frame 482 by a gap 487.

[0316] Fig.67 A top view of an inner frame 480 coupled to an outer frame 482 is shown. Anchors 484 are shown protruding radially outward from the outer frame 482. The anchors 484 may be circumferentially spaced from one another.

[0317] In an example, once deployed, the anchor 484 can be used to extend over the native valve leaflets and be positioned radially outside of the native valve leaflets for anchoring. Fig.68 The prosthetic valve 491 is shown deployed to a native valve with the anchors 484 positioned radially outward of the native valve leaflets 492a, b. A sealing skirt 497 may be positioned on the outer frame 482 as disclosed herein in the examples.

[0318] Prosthetic valve 491 can include one or more prosthetic valve leaflets, similar to other examples of prosthetic valves disclosed herein. Unless otherwise noted, prosthetic valve 491 can be configured similarly to examples of prosthetic valves disclosed herein.

[0319] The outer frame 482 may advantageously include anchors 484 such that the inner frame 480 will receive the pressure load (directed toward movement of the prosthetic valve leaflets), while the anchoring load will be received by the outer frame 482. Thus, the inner frame 480 will have a less load on it than a configuration in which the inner frame includes anchors (e.g., as in Figure 3 ). The inner frame may further have a reduced curling strain when in a curling operation.

[0320] In the example, the outer frame has a thickness 494 in the radial dimension (radial thickness) (in Fig.69 The inner frame may be smaller than the inner frame in radial dimension (in Fig.69 ). Thus, the thickness 494 of the anchor 484 can be less than the thickness 496 of the inner frame. The smaller thickness 494 of the outer frame and anchor can allow the anchor to be formed into a tighter or smaller radius of curvature than a thicker frame. For example, an anchor having the same thickness as the outer frame can be able to be formed into a tighter or smaller radius of curvature than an anchor having the same thickness as the inner frame. The thinner anchor can further exert lower forces on the implant site. For example, the force on the valve annulus of the heart can be reduced. The possibility of conductive interference can be reduced.

[0321] In an example, anchor 498 can be configured to clamp with a portion of a prosthetic valve. Anchor 498 can be configured to clamp the leaflet between anchor 498 and a portion of a prosthetic valve to anchor to the leaflet. For example, Fig.69 A configuration is shown in which the anchor 498 is configured to clamp the leaflet between the anchor 498 and the outer frame 500 to secure the leaflet between the anchor 498 and the outer frame 500. The anchor 498 can provide a radially inward force to the leaflet to press the leaflet relative to the outer frame 500.

[0322] The anchor 498 can be biased radially inward against the outer frame 500. For example, the anchor 498 can include a distal ring portion 502 that can angle a tip portion 504 of the anchor 498 proximally and direct the tip portion 504 radially inward toward the outer frame 500. The tip portion 504 can include a clamping portion configured to clamp against the outer frame 500. In an example, the sealing skirt 501 can be coupled to the outer frame 500.

[0323] The anchor 498 may be maintained in an elongated configuration prior to deployment (similar to Fig.57 The tip portion 504 can extend distally. The anchor 498 can be released to extend radially outward and flipped in place to extend proximally (e.g., Fig.70). Anchor 498 can be positioned radially outside of leaflet 492a and can be rotated to clamp toward outer frame 500. Anchor 498 can press native valve leaflet 492a radially inward and against outer frame 500, as shown in FIG. Fig.70 As shown in . The native valve leaflets 492a can be clamped in place, and such clamping can resist proximal (or atrial) and distal (or ventricular) movement of the prosthetic valve. Improved anchoring to the implant site can result.

[0324] Figure 63-70 Features of the examples may be used alone or in combination with any other examples disclosed herein.

[0325] Fig.71 –76 shows an example in which the anchor 510 extends proximally. The anchor 510 can include an elongated arm, which can extend linearly in an example. The anchors 510 can each include a lever arm, which can include a counter-lever portion 512 on opposite sides of the fulcrum 514. The tip portion 516 of the anchor 510 can extend proximally from the fulcrum 514. The anchor 510 can be configured so that a radially inward force applied to the counter-lever portion 512 can cause the tip portion 516 of the anchor 510 to pivot radially outward about the fulcrum 514 and extend the distance of the tip portion 516 from the outer frame 520. When the radially inward force applied to the counter-lever portion 512 decreases, the anchor 510 can be biased to move the tip portion 516 radially inward. The anchor 510 can be configured to be actuated to change the radial position of the anchor 510. In an example, the anchor 510 can be coupled to the frame 520 via sutures or another form of coupling. The anchor 510 can be coupled to the distal apex or another portion of the frame 520 as desired.

[0326] The counter lever portion 512 may include one or more actuator couplers 522, which may be configured to be coupled to an actuator assembly in an example. In an example, the actuator assembly may include components of a delivery system and may be used to actuate the anchor 510 during a deployment procedure as needed. For example, the actuator coupler 522 may include an eyelet configured to engage with one or more tethers of the actuator assembly, or may have another configuration as needed. In an example, the actuator coupler 522 may be positioned at a distal portion of the outer frame 520. The actuator coupler 522 may be configured to be pulled radially inward by the actuator assembly to deflect the tip portion 516 of the anchor 510 radially outward.

[0327] The outer frame 520 can include a plurality of struts 521 forming a lattice structure. The lattice structure can have a plurality of openings 524. The tip portion 516 of the anchor 510 can be aligned with the opening 524 of the outer frame 520, which opening is defined by one or more struts in an example. The position of the anchor 510 can allow the anchor 510 to be pulled radially inward and reduce the outer diameter of the prosthetic valve in a compressed or crimped configuration.

[0328] Fig.72 There is shown a side cross-sectional view illustrating the location of the anchor 510. The tip portion 516 of the anchor 510 can extend proximally.

[0329] Figures 73-76 An exemplary deployment sequence of a prosthetic valve utilizing outer frame 520 and anchor 510 is shown. Fig.73 The prosthetic valve is shown in a compressed or crimped configuration within a capsule 526 of a delivery system. The anchors 510 can extend proximally with a tip portion 516 extending proximally from a fulcrum 514. The tip portion 516 of each of the anchors 510 is configured to extend proximally when the prosthetic valve is in a crimped configuration.

[0330] Each of the anchors 510 can be configured to be actuated to deflect the tip portion 516 radially outward from the outer frame 520 .

[0331] In an example, the actuator assembly 530 can be used to actuate the anchor 510. For example, the actuator assembly 530 can include one or more tethers 532 configured to engage the coupling 522. In an example, the tether 532 can include a rope, cable, line, or other form of tether. The tether 532 can form a loop with two lengths extending through the delivery system. Therefore, a certain length of the tether 532 can be cut to allow the tether 532 to be pulled from the coupling 522 to be released from the corresponding coupling 522. The actuator assembly 530 can include a shaft 534, which can engage the tether 532. The shaft 534 can include a sheath or shield that can extend above the tether 532 and allow the tether 532 to be pulled or released to actuate the anchor 510.

[0332] Fig.74A prosthetic valve partially released from capsule 526 is shown. Actuator assembly 530 can be operated to apply a radially inward force to the anti-lever portion 512 of anchor 510. For example, tether 532 can be pulled radially inward to pull anti-lever portion 512 radially inward. The radially inward movement of anti-lever portion 512 can cause tip portion 516 to extend radially outward. Tip portion 516 can be positioned radially outside of a natural valve leaflet in a position anchored to the leaflet. In an example, the prosthetic valve can be positioned distally of the natural valve annulus, or moved distally to allow tip portion 516 to hook onto the natural valve leaflet or be positioned radially outside of the natural valve leaflet. In an example, the prosthetic valve can be retracted proximally to place the natural valve leaflet on tip portion 516.

[0333] The prosthetic valve can continue to be released and expanded, e.g. Fig.75 As shown in . Actuator assembly 530 can continue to apply radially inward force to counter lever portion 512. Tip portion 516 can be in a radially outward expanded state. Actuator assembly 530 can be released to allow tip portion 516 to move radially inward, as shown in . Fig.76 As shown in . Anchor 510 can anchor the prosthetic valve in place. Anchor 510 can apply a clamping force to the native valve leaflets. Anchor 510 can clamp the native valve leaflets relative to the outer frame 520. Anchor 510 can press the native valve leaflets relative to the sealing skirt, which is positioned on the outer frame 520 and covers the opening 524, as shown in Fig.71 The anchor 510 can apply a clamping force at another location as needed. The clamping force can resist the proximal (or atrial) movement of the prosthetic valve and the distal (or ventricular) movement of the prosthetic valve.

[0334] Figures 71-76 Features of the examples may be used alone or in combination with any other examples disclosed herein.

[0335] Fig.77 -84 shows a frame 540 that can be used in the prosthetic valve of the examples herein. The frame 540 is Fig.77 540 is shown in an expanded or deployed configuration. The frame 540 may include an inner frame 542 and may include an outer frame 544. The inner frame 542 is Fig.82 544 is shown as being separated from the outer frame 544. The outer frame 544 is Fig.83 Shown in FIG. 5 as separated from the inner frame 542 .

[0336] In an example, the portion of the frame 540 including the inner frame 542 and the outer frame 544 can be cut from a single piece of material. Thus, in an example, the outer frame 544 can be integral or unitary with the inner frame 542. A material having a cylindrical shape can be cut to form the portion of the frame 540 including the inner frame 542 and the outer frame 544. The outer frame 544 can be deflected radially outward from the inner frame 542. For example, the outer frame 544 can be deflected outward and shaped to be positioned outside the inner frame 542 in an example.

[0337] The inner frame 542 may have a cylindrical shape in an expanded or deployed configuration, such as Fig.77 The inner frame 542 may include a plurality of struts 546. The plurality of struts 546 may define a plurality of openings 548. The struts 546 may be formed into a lattice structure, wherein in an example, a plurality of struts 546a-d form a strut unit. An exemplary strut unit is shown in FIG. Fig.77 546a-d that form a diamond shape and define an opening 548. In an example, a strut unit may include a closed strut unit that is completely defined by struts 546a-d. Three of such strut units that are circumferentially spaced apart from each other are shown in FIG. Fig.77 In an example, the inner frame can include circumferentially extending struts 546e that can couple strut units to each other. Other configurations of the inner frame 542 can be utilized in an example.

[0338] In an example, inner frame 542 can be configured to support one or more prosthetic valve leaflets. Fig.77 A configuration in which three prosthetic valve leaflets can be used is shown. The seams of the prosthetic valve leaflets can be positioned at Fig.77 At each of the three support units of the inner frame 542 shown in .

[0339] The outer frame 544 may include a plurality of struts 550. The struts 550 may be formed into a lattice structure, wherein in an example, a plurality of struts 550a-d form a strut unit. An exemplary strut unit is Fig.77 550a-d that form a rhombus shape and define an opening 552. Three of such strut units that are circumferentially spaced from each other are shown in FIG. Fig.77 In an example, the outer frame can include smaller strut units 554, 556 that extend proximally and distally from a central portion or middle portion of the outer frame 544, respectively. The smaller strut units 554, 556 can be circumferentially positioned between larger strut units. Three pairs of smaller strut units 554, 556 circumferentially positioned between adjacent larger strut units are shown in FIG. Fig.77 middle.

[0340] The outer frame 544 and the inner frame 542 may each include circumferentially extending struts 546e.

[0341] At least a portion of the inner frame 542 is aligned within at least one of the plurality of openings 552 of the outer frame 544. For example, a strut unit formed by struts 546a-d is aligned within an opening 552 of the outer frame 544 defined by struts 550a-d. Fig.79 Such alignment is shown. The strut units formed by struts 546a-d can include closed strut units. The diamond-shaped strut units of the inner frame 542 can be aligned within the diamond-shaped strut units of the outer frame 544.

[0342] Fig.78 A perspective view of frame 540 rotated from the position shown in 77 is shown.

[0343] Fig.79 A side view of the frame 540 is shown. The outer frame 544 can include a proximal portion 558, a distal portion 562, and a central portion 560. The outer frame 544 is shown as having an hourglass shape in the expanded configuration, wherein the proximal portion 558 flares radially outward from the central portion 560 of the outer frame 544. The distal portion 562 of the outer frame 544 flares radially outward from the central portion 560 of the outer frame 544. The central portion 560 can include a narrow portion or waist portion positioned between the proximal portion 558 and the distal portion 562.

[0344] Fig.80 79 shows a side view of the frame 540 rotated from the position shown in FIG. The inner frame 542 can have a cylindrical shape in the expanded configuration (in Fig.82 ). In examples, the inner frame 542 can have other configurations including non-cylindrical or asymmetrical profiles.

[0345] Fig.81 A top view of frame 540 is shown. Fig.82 An isolated view of the inner frame 542 is shown without the outer frame 544. Fig.83 An isolated view of the outer frame 544 is shown without the inner frame 542.

[0346] The frame 540 can be configured to expand radially outward from a crimped or compressed configuration to an expanded configuration. The inner frame 542 and the outer frame 544 can each have a cylindrical shape in the crimped or compressed configuration.

[0347] The configuration of the frame 540 cut from a single piece of material can allow the frame 540 to be moved into a curled or compressed configuration, wherein the strut units of the inner frame 542 can be positioned within the openings of the strut units of the outer frame 544. For example, such a configuration is shown in Fig.84 When frame 540 is in the crimped or compressed configuration, at least a portion of inner frame 542 is located within at least one of the openings of outer frame 544. The location of inner frame 542 within the openings of the strut units of outer frame 544 can allow for a reduction in the outer diameter of the prosthetic valve due to the outer frame not being layered over the inner frame, for example, to produce Figure 5 For example, Fig.85 Shows the slave in a curled or compressed configuration Fig.84 The view shown in FIG. 5 is a view of a frame 540 of a rotated view.

[0348] Fig.86 A top view of the frame 540 is shown in a curled or compressed configuration. Fig.85 ) in such a configuration has the same diameter or radial distance as the inner frame 542. The frame can surround the central axis 563 of the prosthetic valve.

[0349] Variations of the frame 540 may be provided. For example, Fig.87 A configuration is shown in which one or more distal anchors 564 can be coupled to an outer frame 566. In an example, the distal anchors 564 can be coupled to the distal apex of the struts of the outer frame 566. The distal anchors 564 can form hooks for anchoring to a native valve. The distal anchors 564 can have a hook-shaped configuration. The frame 568 can be configured similarly to the frame 540 in other ways. In an example, the distal anchors 564 can be configured to be radially positioned outside of the native valve leaflets.

[0350] Fig.88 A variation is shown in which a distal anchor 570 can be coupled to an inner frame 572. In an example, the distal anchor 570 can be coupled to the distal apex of a strut of the inner frame 572. The distal anchor 570 can form a hook for anchoring to a native valve. The distal anchor 570 can have a hook-shaped configuration. The cells of the outer frame 578 can include open strut cells with cutouts 580 that can allow the distal anchor 570 to pass radially outward for anchoring. The cutouts 580 can further allow the frame 582 to have a uniform diameter when curled or compressed (e.g., as Fig.86 ). At least a portion of the inner frame 572 can be aligned with at least a portion of the plurality of open strut units. Frame 582 can be configured similarly to frame 540 in other ways.

[0351] Fig.89 A schematic diagram of the location of the cutout 580 relative to the distal anchor 570 is shown to allow passage of the outer frame 578 .

[0352] The anchors 564, 570 can extend distally and can comprise distal anchors of the corresponding frame.

[0353] In an example, the anchors 564, 570 can be configured to form hooks for gripping the leaflets of a native valve. Fig.70 The leaflets can be clamped relative to a portion of the frame in the manner disclosed in or in another manner as desired. In an example, anchors 564, 570 can clamp the leaflets to the corresponding external frame.

[0354] In an example, once deployed, the outer frame 544 can include an anchoring body that can be used to anchor the prosthetic valve 590 to the implantation site. Fig.90 The deployed configuration of the prosthetic valve 590 is shown. The proximal portion 558 of the outer frame 544 can include a proximal anchor, and the distal portion 562 of the outer frame 544 can include a distal anchor. The proximal anchor can be positioned on the atrial side of the native valve. The distal anchor can be positioned on the ventricular side of the native valve. The open shapes of the proximal portion 558 and the distal portion 562 can be used to hinder the ventricular and atrial movement of the prosthetic valve 590, respectively.

[0355] In an example, a sealing skirt 592 can be positioned on the frame 540. The sealing skirt 592 can extend over the opening of the pillar to cover and seal the fluid flow therethrough. The prosthetic valve 590 can include one or more prosthetic valve leaflets 596. In an example, the inner portion of the sealing skirt 592 can define a flow channel 594 of the prosthetic valve 590, and the prosthetic valve leaflets 596 can be positioned within the flow channel. The prosthetic valve leaflets 596 can be sutured or otherwise connected to the sealing skirt 592.

[0356] Variations of the frame 540 and the prosthetic valve 590 may be provided. For example, Figures 91-93 Shows the formation Fig.77 The struts of the inner frame 542 in the embodiment deflect radially outward to form the outer frame 600 and form Fig.77 The struts of the outer frame 544 in the embodiment maintain a cylindrical configuration to form a variation of the inner frame 602. Thus, in an example, the cells of the outer frame 600 can be aligned with the openings 604 of the cells of the inner frame 602. In a compressed or curled configuration, the frame can have, for example, Fig.84 and 85 At least a portion of the outer frame 600 is located within at least one of the openings of the inner frame 602 when the frame is in the curled configuration.

[0357] Fig.91A side view of a unit of the outer frame 600 is shown aligned within an opening 604 of the inner frame 602. At least a portion of the outer frame 600 is aligned within at least one of the plurality of openings 604 of the inner frame 602. The inner frame 602 is provided with support posts 601a-d (corresponding to Fig.77 The support units formed by the support 550a-d shown in FIG. 600 may include closed support units. The diamond support units 605 (corresponding to Fig.77 The struts 546a-d) shown in FIG. 604 can be aligned within the diamond-shaped strut units of the inner frame 602.

[0358] Fig.92 A side view of an outer frame 600 protruding from an inner frame 602 is shown.

[0359] In an example, the outer frame 600 can be configured to clamp with a portion of the heart. For example, the outer frame 600 can clamp with a natural heart valve annulus to anchor a prosthetic valve in place. The outer frame 600 can clamp a portion of the heart between the proximal portion 608 and the distal portion 610 of the frame 600 to anchor the frame to the heart. Fig.93 An exemplary deployed configuration is shown in which the outer frame 600 clamps to the atrial and ventricular sides of the native heart valve to anchor the prosthetic valve 606 in place. Other configurations may be used in examples.

[0360] Fig.55A Features of the example of -93 may be used alone or in combination with any other example disclosed herein.

[0361] Examples of prosthetic valves may be used in a mitral valve as disclosed herein, or may be used in other deployment locations such as a native tricuspid valve or other deployment locations. Deployment to the aortic valve or pulmonary valve, as well as other implantation sites, is contemplated.

[0362] Various modifications of the examples disclosed herein may be provided. Between examples, features of the examples may be modified, replaced, excluded, or combined as needed. Combinations of features between examples may be provided as needed. Combinations of features between examples may be provided, and other features of such examples may be excluded as needed.

[0363] The various examples of sealing skirts disclosed herein can have various forms, including cloth skirts, foam skirts, or woven skirts as desired. Various materials can be used as desired.

[0364] Implants disclosed herein may include prosthetic heart valves or other forms of implants, such as stents or filters, or diagnostic devices, etc. The implant may be an expandable implant configured to move from a compressed or unexpanded state to an expanded or expanded state. The implant may be a compressible implant configured to compress inwardly to have a reduced outer profile and move the implant to a compressed or unexpanded state.

[0365] Various forms of delivery devices can be used in the examples disclosed herein. Delivery devices as disclosed herein can also be used for replacement and repair of the aorta, mitral valve, tricuspid valve and pulmonary artery. Delivery devices can include delivery devices for delivering other forms of implants, such as stents or filters, or diagnostic devices, etc.

[0366] The implants and systems disclosed herein can be used for transcatheter mitral or tricuspid valve implantation, as well as transaortic valve implantation (TAVI) or replacement of other natural heart valves (e.g., pulmonary valve). The delivery devices and systems disclosed herein can be used for transarterial access (including transfemoral access) to the patient's heart. The delivery devices and systems can be used for transcatheter percutaneous surgery, including transarterial surgery, which can be transfemoral or transjugular. In addition, transapical surgery can also be used. Other surgeries can be used as needed.

[0367] In addition, the methods herein are not limited to the specifically described methods and may include methods using the systems and devices disclosed herein. The steps of the methods may be modified, eliminated, or added using the systems, devices, and methods disclosed herein. In an example, the examples disclosed herein may include a system for implantation in a human body.

[0368] For the purpose of this description, certain aspects, advantages and novel features of examples of the present disclosure are described herein. The disclosed methods, devices and systems should not be interpreted as limiting in any way. On the contrary, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, together and in various combinations and sub-combinations of each other. The methods, devices and systems are not limited to any specific aspects or features or combinations thereof, and the disclosed examples do not require the presence of any one or more specific advantages or solutions to problems. Features, elements or combinations of an example can be combined into other examples herein.

[0369] Example 1: A prosthetic valve configured to be deployed to a natural valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; a sealing body radially positioned outside of the one or more prosthetic valve leaflets and configured to seal a portion of the natural valve; one or more anchors, the one or more anchors configured to anchor the one or more prosthetic valve leaflets to the natural valve; and one or more magnets, the one or more magnets configured to pull the sealing body and at least one of the one or more anchors together.

[0370] Example 2: According to any example herein, in particular the prosthetic valve of Example 1, wherein the sealing body comprises a frame.

[0371] Example 3: The prosthetic valve of any example herein, particularly Example 2, wherein the frame comprises an outer frame positioned radially outside of an inner frame, the inner frame supporting the one or more prosthetic valve leaflets.

[0372] Example 4: According to any example herein, in particular the prosthetic valve described in Example 3, wherein the outer frame includes a proximal portion and a distal portion connected to the inner frame, and the distal portion includes the one or more magnets or one or more ferromagnetic materials configured to be attracted to the one or more magnets.

[0373] Example 5: The prosthetic valve according to any example herein, particularly examples 1 to 4, wherein the sealing body includes a sealing skirt.

[0374] Example 6: The prosthetic valve according to any example herein, particularly examples 1 to 5, wherein the one or more magnets are positioned on the one or more anchors.

[0375] Example 7: The prosthetic valve according to any example herein, particularly examples 1 to 6, wherein the one or more magnets are positioned on the sealing body.

[0376] Example 8: According to any example herein, in particular the prosthetic valve of Examples 1 to 7, further comprising one or more ferromagnetic materials, wherein the one or more magnets are configured to attract the one or more ferromagnetic materials.

[0377] Example 9: According to any example herein, specifically the prosthetic valve described in Example 8, wherein the one or more ferromagnetic materials are positioned on the sealing body and the one or more magnets are positioned on the one or more anchors; or the one or more ferromagnetic materials are positioned on the one or more anchors and the one or more magnets are positioned on the sealing body.

[0378] Example 10: The prosthetic valve of any example herein, particularly examples 1 to 9, wherein the one or more anchors are configured in a hook-shaped configuration.

[0379] Example 11: The prosthetic valve according to any example herein, particularly examples 1 to 10, wherein each of the one or more anchors is configured to hook onto a distal tip of a native valve leaflet.

[0380] Example 12: According to any example herein, in particular the prosthetic valve described in Examples 1 to 11, the one or more anchors are configured to be radially positioned outside the native valve leaflets, and the sealing body is configured to be radially positioned inside the native valve leaflets.

[0381] Example 13: The prosthetic valve of any example herein, particularly Example 12, wherein the one or more magnets are configured to clamp the native valve leaflets between the sealing body and the one or more anchors.

[0382] Example 14: The prosthetic valve of any example herein, particularly Examples 1 to 13, wherein the one or more magnets include a plurality of magnets positioned on the sealing body and circumferentially spaced apart from each other.

[0383] Example 15: The prosthetic valve according to any example herein, particularly examples 1 to 14, wherein the prosthetic valve is configured to be deployed to the mitral valve or the tricuspid valve.

[0384] Example 16: A method comprising: deploying a prosthetic valve to a natural valve, the prosthetic valve comprising: one or more prosthetic valve leaflets, a sealing body radially positioned outside of the one or more prosthetic valve leaflets and configured to seal a portion of the natural valve, one or more anchors, the one or more anchors configured to anchor the one or more prosthetic valve leaflets to the natural valve, and one or more magnets, the one or more magnets configured to pull the sealing body and at least one of the one or more anchors together.

[0385] Example 17: The method according to any example herein, particularly Example 16, wherein the sealing body includes a frame.

[0386] Example 18: The method according to any example herein, particularly Example 17, wherein the frame comprises an outer frame positioned radially outside of an inner frame, the inner frame supporting the one or more prosthetic valve leaflets.

[0387] Example 19: According to any example described herein, in particular the method described in Example 18, wherein the outer frame includes a proximal portion and a distal portion connected to the inner frame, and the distal portion includes the one or more magnets or one or more ferromagnetic materials configured to be attracted to the one or more magnets.

[0388] Example 20: According to any example herein, in particular the method of examples 16 to 19, wherein the sealing body includes a sealing skirt.

[0389] Example 21: The method according to any example herein, particularly examples 16 to 20, wherein the one or more magnets are positioned on the one or more anchors.

[0390] Example 22: The method according to any example herein, particularly examples 16 to 21, wherein the one or more magnets are positioned on the sealing body.

[0391] Example 23: According to any example herein, in particular the method of Examples 16 to 22, wherein the one or more magnets are configured to attract the one or more ferromagnetic materials.

[0392] Example 24: A prosthetic valve configured to be deployed to a natural valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; and one or more anchors, the one or more anchors configured to anchor the one or more prosthetic valve leaflets to the natural valve, each of the one or more anchors comprising one or more grooves, the one or more grooves configured to increase the flexibility of the corresponding anchor.

[0393] Example 25: The prosthetic valve of any example herein, particularly Example 24, wherein each of the one or more anchors is configured in a hook configuration.

[0394] Example 26: The prosthetic valve of any example herein, particularly Example 24 or Example 25, wherein each of the one or more anchors is configured to hook onto a distal tip of a native valve leaflet.

[0395] Example 27: A prosthetic valve according to any example herein, specifically Examples 24 to 26, wherein each of the one or more anchors extends radially outward from a valve body supporting the one or more prosthetic valve leaflets, and each of the one or more anchors includes a radially inward facing surface and a radially outward facing surface, and the one or more grooves are positioned on the radially inward facing surface.

[0396] Example 28: The prosthetic valve of any example herein, particularly Example 27, wherein the one or more grooves are positioned on the radially outward facing surface.

[0397] Example 29: According to any example herein, in particular the prosthetic valve of Examples 24 to 28, each of the one or more anchors comprises an elongated arm having a certain length, and the one or more grooves extend transversely relative to the length of the elongated arm.

[0398] Example 30: The prosthetic valve of any example herein, particularly Example 29, wherein the one or more grooves include a plurality of grooves spaced apart from one another along the length of the elongated arm.

[0399] Example 31: The prosthetic valve of any example herein, particularly Examples 24 to 30, wherein each of the one or more anchors comprises a curved portion having a convex curvature, and the one or more grooves are positioned on the curved portion.

[0400] Example 32: According to any example herein, in particular the prosthetic valve described in Examples 24 to 31, each of the one or more anchors extends radially outward from the valve body, and the one or more grooves increase the flexibility of the corresponding anchor in the radially inward direction.

[0401] Example 33: The prosthetic valve of any example herein, particularly Examples 24 to 32, wherein the prosthetic valve is configured to be deployed to the mitral valve or the tricuspid valve.

[0402] Example 34: A method comprising: deploying a prosthetic valve to a natural valve, the prosthetic valve comprising: one or more prosthetic valve leaflets, and one or more anchors, the one or more anchors configured to anchor the one or more prosthetic valve leaflets to the natural valve, each of the one or more anchors comprising one or more grooves, the one or more grooves configured to increase the flexibility of the corresponding anchor.

[0403] Example 35: The method according to any example herein, particularly Example 34, wherein each of the one or more anchors is configured in a hook configuration.

[0404] Example 36: The method according to any example herein, particularly Example 34 or Example 35, wherein each of the one or more anchors is configured to hook onto a distal tip of a native valve leaflet.

[0405] Example 37: According to any example described herein, specifically the method described in Examples 34 to 36, each of the one or more anchors extends radially outward from a valve body supporting the one or more prosthetic valve leaflets, and each of the one or more anchors includes a radially inward facing surface and a radially outward facing surface, and the one or more grooves are positioned on the radially inward facing surface.

[0406] Example 38: The method according to any example herein, particularly Example 37, wherein the one or more grooves are positioned on a radially outward facing surface.

[0407] Example 39: According to any example herein, in particular the method of Examples 34 to 38, each of the one or more anchors comprises an elongated arm having a certain length, and the one or more grooves extend transversely relative to the length of the elongated arm.

[0408] Example 40: According to any example herein, in particular the method of Example 39, wherein the one or more grooves include a plurality of grooves spaced apart from each other along the length of the elongated arm.

[0409] Example 41: According to any example herein, particularly the method of Examples 34 to 40, each of the one or more anchors includes a curved portion having a convex curvature, and the one or more grooves are positioned on the curved portion.

[0410] Example 42: A prosthetic valve configured to be deployed to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; and one or more anchors configured to anchor the one or more prosthetic valve leaflets to the native valve, each of the one or more anchors comprising a coil.

[0411] Example 43: The prosthetic valve of any example herein, particularly Example 42, wherein the coil forms an elongated arm.

[0412] Example 44: The prosthetic valve of any example herein, particularly Example 42 or Example 43, wherein the coil comprises a first coil portion and a second coil portion, the first coil portion being stiffer than the second coil portion.

[0413] Example 45: A prosthetic valve according to any example herein, particularly Example 44, wherein each of the one or more anchors extends radially outward from a valve body supporting the one or more prosthetic valve leaflets, and the second coil portion is positioned radially outside of the first coil portion.

[0414] Example 46: The prosthetic valve of any example herein, particularly Examples 42 to 45, wherein each of the one or more anchors comprises a reinforcing arm extending along the coil.

[0415] Example 47: The prosthetic valve of any example herein, particularly Example 46, wherein each of the one or more anchors is curved to include an inner radius and an outer radius, and the reinforcing arm extends outward from the coil along the outer radius.

[0416] Example 48: The prosthetic valve of any example herein, particularly Examples 42 to 47, wherein each of the one or more anchors is configured in a hook configuration.

[0417] Example 49: The prosthetic valve of any example herein, particularly Examples 42 to 48, wherein each of the one or more anchors is configured to hook onto a distal tip of a native valve leaflet.

[0418] Example 50: The prosthetic valve of any example herein, particularly Examples 42 to 49, wherein each of the one or more anchors comprises a curved portion having a convex curvature, and the coil is positioned on the curved portion.

[0419] Example 51: The prosthetic valve of any example herein, particularly Examples 42 to 50, wherein each of the one or more anchors extends radially outward from the valve body, and the coil increases the flexibility of the corresponding anchor in a radially inward direction.

[0420] Example 52: According to any example herein, in particular the prosthetic valve described in Examples 42 to 51, wherein the coil comprises a spring coil.

[0421] Example 53: The prosthetic valve of any example herein, particularly Examples 42 to 52, wherein the coil comprises a cut hypotube.

[0422] Example 54: A prosthetic valve according to any example herein, specifically Examples 42 to 53, wherein the valve body supports the one or more prosthetic valve leaflets, and each of the one or more anchors includes a connecting portion for connecting to the valve body and extending radially outward to a tip portion of the corresponding anchor, and the coil extends radially outward from the connecting portion to the tip portion.

[0423] Example 55: According to any example herein, in particular the prosthetic valve of Examples 42 to 54, each of the one or more anchors comprises an overmold positioned over the corresponding coil.

[0424] Example 56: According to any example herein, in particular the prosthetic valve described in Examples 42 to 55, wherein the valve body supports the one or more prosthetic valve leaflets and has a proximal portion and a distal portion, and the one or more anchors extend from the proximal portion of the valve body.

[0425] Example 57: The prosthetic valve of any example herein, particularly Example 56, further comprising a plurality of hook anchors positioned at a distal portion of the valve body.

[0426] Example 58: The prosthetic valve of any example herein, particularly Examples 42 to 57, wherein the one or more anchors each comprise an atrial anchor configured to anchor within an atrium of the heart.

[0427] Example 59: According to any example herein, in particular the prosthetic valve described in Examples 42 to 58, wherein the valve body supports the one or more prosthetic valve leaflets, and the one or more anchors include a plurality of anchors extending from the valve body and circumferentially spaced apart from each other.

[0428] Example 60: The prosthetic valve of any example herein, particularly Examples 42 to 59, wherein the one or more anchors support a sealing body for sealing with the native valve.

[0429] Example 61: The prosthetic valve of any example herein, particularly Examples 42 to 60, wherein the prosthetic valve is configured to be deployed to the mitral valve or the tricuspid valve.

[0430] Example 62: A method comprising: deploying a prosthetic valve to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets, and one or more anchors, the one or more anchors configured to anchor the one or more prosthetic valve leaflets to the native valve, each of the one or more anchors comprising a coil.

[0431] Example 63: According to any example herein, in particular the method of Example 62, wherein the coil forms an elongated arm.

[0432] Example 64: The method according to any example herein, specifically Example 62 or Example 63, wherein the coil includes a first coil portion and a second coil portion, and the first coil portion has a stiffness greater than the second coil portion.

[0433] Example 65: The method of any example described herein, particularly Example 64, wherein each of the one or more anchors extends radially outward from a valve body supporting the one or more prosthetic valve leaflets, and the second coil portion is positioned radially outside of the first coil portion.

[0434] Example 66: According to any example herein, particularly the method of Examples 62 to 65, each of the one or more anchors includes a reinforcing arm extending along the coil.

[0435] Example 67: The method of any example herein, particularly Example 66, wherein each of the one or more anchors is curved to include an inner radius and an outer radius, and the reinforcing arm extends outward from the coil along the outer radius.

[0436] Example 68: According to any example herein, particularly the method of Examples 62 to 67, each of the one or more anchors is configured to be in a hook configuration.

[0437] Example 69: The method according to any example herein, particularly Examples 62 to 68, wherein each of the one or more anchors is configured to hook onto a distal tip of a native valve leaflet.

[0438] Example 70: A prosthetic valve configured to be deployed to a natural valve, the prosthetic valve comprising: a valve body, the valve body enclosing a flow channel extending along a longitudinal dimension; one or more prosthetic valve leaflets, the one or more prosthetic valve leaflets extending radially inward from the valve body and positioned within the flow channel; and one or more anchors, the one or more anchors being pivotally connected to the valve body and configured to pivot about the longitudinal dimension to change the radial distance of the one or more anchors from the valve body.

[0439] Example 71: The prosthetic valve of any example herein, particularly Example 70, wherein the flow channel extends along a central axis and each of the one or more anchors is configured to pivot about an axis extending parallel to the central axis.

[0440] Example 72: The prosthetic valve of any example herein, particularly Example 70 or Example 71, wherein each of the one or more anchors is pivotally coupled to the valve body with a hinge.

[0441] Example 73: The prosthetic valve of any example herein, particularly Example 72, wherein each of the one or more anchors includes a tip configured to rotate about a corresponding hinge.

[0442] Example 74: The prosthetic valve of any example herein, particularly Examples 70 to 73, wherein each of the one or more anchors is configured to pivot about the longitudinal dimension to change the maximum radial extension of the prosthetic valve.

[0443] Example 75: The prosthetic valve of any example herein, particularly Examples 70 to 74, wherein each of the one or more anchors has a length, and the length is configured to remain constant when the corresponding anchor is pivoted about the longitudinal dimension.

[0444] Example 76: The prosthetic valve of any example herein, particularly Examples 70 to 75, wherein each of the one or more anchors is configured in a hook configuration.

[0445] Example 77: The prosthetic valve of any example herein, particularly Examples 70 to 76, wherein each of the one or more anchors is configured to hook onto a distal tip of a native valve leaflet.

[0446] Example 78: A prosthetic valve according to any example herein, specifically Examples 70 to 77, wherein each of the one or more anchors includes a distal anchor and the prosthetic valve further includes a proximal frame support connected to the corresponding distal anchor and configured to pivot about the longitudinal dimension with the distal anchor.

[0447] Example 79: A prosthetic valve according to any example herein, specifically Examples 70 to 78, wherein the one or more anchors include a plurality of anchors pivotally connected to the valve body and each configured to pivot about the longitudinal dimension to change the radial distance of the plurality of anchors from the valve body.

[0448] Example 80: The prosthetic valve of any example herein, particularly Example 79, wherein the plurality of anchors are circumferentially spaced apart from one another around the valve body.

[0449] Example 81: According to any example herein, in particular the prosthetic valve described in Examples 70 to 80, each of the one or more anchors is configured to extend perpendicular to the outer surface of the valve body and is configured to extend parallel to the outer surface of the valve body.

[0450] Example 82: The prosthetic valve of any example herein, particularly Examples 70 to 81, further comprising one or more locks configured to lock movement of the one or more anchors about the longitudinal dimension.

[0451] Example 83: The prosthetic valve of any example herein, particularly Examples 70 to 82, wherein the valve body includes an outer surface comprising a sealing body, and the one or more anchors are configured to press the native valve leaflets to the sealing body.

[0452] Example 84: The prosthetic valve of any example herein, particularly Examples 70 to 83, wherein the prosthetic valve is configured to be deployed to the mitral valve or the tricuspid valve.

[0453] Example 85: A method comprising: deploying a prosthetic valve to a natural valve, the prosthetic valve comprising: a valve body, the valve body enclosing a flow channel extending along a longitudinal dimension, one or more prosthetic valve leaflets, the one or more prosthetic valve leaflets extending radially inward from the valve body and positioned within the flow channel, and one or more anchors, the one or more anchors being pivotally connected to the valve body and configured to pivot about the longitudinal dimension to change the radial distance of the one or more anchors from the valve body.

[0454] Example 86: The method according to any example herein, particularly Example 85, wherein the flow channel extends along a central axis, and each of the one or more anchors is configured to pivot about an axis extending parallel to the central axis.

[0455] Example 87: The method of any example herein, particularly Example 85 or Example 86, wherein each of the one or more anchors is pivotally coupled to the valve body with a hinge.

[0456] Example 88: The method according to any example herein, particularly Example 87, wherein each of the one or more anchors includes a tip configured to rotate about a corresponding hinge.

[0457] Example 89: The method of any example herein, particularly Examples 85 to 88, wherein each of the one or more anchors is configured to pivot about the longitudinal dimension to change the maximum radial extension of the prosthetic valve.

[0458] Example 90: According to any example herein, in particular the method of Examples 85 to 89, each of the one or more anchors has a certain length, and the length is configured to remain constant when the corresponding anchor is pivoted about the longitudinal dimension.

[0459] Example 91: According to any example herein, particularly the method of Examples 85 to 90, each of the one or more anchors is configured to be in a hook configuration.

[0460] Example 92: According to any example herein, in particular the method of Examples 85 to 91, each of the one or more anchors is configured to hook onto a distal tip of a native valve leaflet.

[0461] Example 93: A prosthetic valve configured to be deployed to a natural valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; a sealing body radially positioned outside of the one or more prosthetic valve leaflets and configured to seal a portion of the natural valve; one or more anchors configured to anchor the one or more prosthetic valve leaflets to the natural valve; and a band configured to have an adjustable diameter to move the sealing body radially inward or outward.

[0462] Example 94: The prosthetic valve according to any example herein, in particular Example 93, further comprising an inner frame positioned radially inside the sealing body.

[0463] Example 95: The prosthetic valve of any example herein, particularly Example 93 or Example 94, wherein the sealing body includes a sealing skirt.

[0464] Example 96: The prosthetic valve of any example herein, particularly Examples 93 to 95, wherein each of the one or more anchors is configured to hook onto a distal tip of a native valve leaflet.

[0465] Example 97: The prosthetic valve of any example herein, particularly Examples 93 to 96, wherein the band comprises a ring having an end and a portion configured to overlap the end.

[0466] Example 98: The prosthetic valve of any example herein, particularly Example 97, further comprising a connector positioned at the end, and the portion is configured to slide through the connector to adjust the diameter of the band.

[0467] Example 99: The prosthetic valve of any example herein, particularly Example 98, further comprising an adjustment mechanism positioned at the end and configured to adjust the diameter of the band.

[0468] Example 100: The prosthetic valve of any example herein, particularly Examples 93 to 99, wherein the band includes a first end portion and a second end portion, the first end portion being configured to overlap the second end portion.

[0469] Example 101: The prosthetic valve of any example herein, particularly Example 100, wherein the first end portion is configured to extend along a length of the second end portion.

[0470] Example 102: The prosthetic valve of any example herein, particularly Example 100 or Example 101, wherein the band is configured to adjust the diameter by changing the amount of overlap of the first end portion with the second end portion.

[0471] Example 103: The prosthetic valve of any example herein, particularly Examples 93 to 102, wherein the band is annular.

[0472] Example 104: The prosthetic valve of any example herein, particularly Examples 93 to 103, wherein the band is configured to have an adjustable diameter that is adjusted in vivo.

[0473] Example 105: The prosthetic valve of any example herein, particularly Examples 93 to 104, wherein the sealing body is elastic.

[0474] Example 106: The prosthetic valve of any example herein, particularly Examples 93 to 105, wherein the band extends circumferentially around the sealing body.

[0475] Example 107: The prosthetic valve of any example herein, particularly Examples 93 to 106, wherein the prosthetic valve is configured to be deployed to the mitral valve or the tricuspid valve.

[0476] Example 108: A method comprising: deploying a prosthetic valve to a natural valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; a sealing body radially positioned outside of the one or more prosthetic valve leaflets and configured to seal a portion of the natural valve; one or more anchors, the one or more anchors configured to anchor the one or more prosthetic valve leaflets to the natural valve; and a band, the band configured to have an adjustable diameter to move the sealing body radially inward or outward.

[0477] Example 109: The method of any example herein, particularly Example 108, wherein the inner frame is positioned radially inside the sealing body.

[0478] Example 110: The method according to any example herein, particularly Example 108 or Example 109, wherein the sealing body includes a sealing skirt.

[0479] Example 111: The method of any example herein, particularly Examples 108 to 110, wherein each of the one or more anchors is configured to hook onto a distal tip of a native valve leaflet.

[0480] Example 112: The method of any example herein, particularly Examples 108 to 111, wherein the band comprises a loop having an end and a portion configured to overlap the end.

[0481] Example 113: The method according to any example herein, particularly Example 112, wherein a coupling is positioned at the end, and the portion is configured to slide through the coupling to adjust the diameter of the band.

[0482] Example 114: The method according to any example herein, particularly Example 113, wherein an adjustment mechanism is positioned at the end and is configured to adjust the diameter of the band.

[0483] Example 115: The method according to any example herein, particularly Examples 108 to 114, wherein the band includes a first end portion and a second end portion, the first end portion being configured to overlap with the second end portion.

[0484] Example 116: A prosthetic valve configured to be deployed to a natural valve, the prosthetic valve comprising: a valve frame surrounding a flow channel; one or more prosthetic valve leaflets, the one or more prosthetic valve leaflets connected to the valve frame and extending radially inward from the valve frame and positioned within the flow channel; and a sealing skirt, the sealing skirt being positioned radially outward from the valve frame, having a certain space between the sealing skirt and the valve frame, the sealing skirt being in a tensioned state and configured to deflect to conform to the shape of the natural valve.

[0485] Example 117: The prosthetic valve of any example herein, particularly Example 116, wherein the sealing skirt surrounds the valve frame.

[0486] Example 118: According to any example herein, specifically the prosthetic valve described in Example 116 or Example 117, further comprising: a proximal tensioning body positioned at the proximal portion of the prosthetic valve; and a distal tensioning body positioned at the distal portion of the prosthetic valve, and wherein the sealing skirt includes a proximal end connected to the proximal tensioning body and a distal end connected to the distal tensioning body, and the sealing skirt is tensioned by the proximal tensioning body and the distal tensioning body.

[0487] Example 119: The prosthetic valve of any example herein, particularly Example 118, wherein the proximal tensioning body comprises an arm having a first end coupled to a proximal portion of the valve frame and a second end extending radially outward from the first end.

[0488] Example 120: The prosthetic valve of any example herein, particularly Example 118 or Example 119, wherein the distal tensioning body comprises an arm having a first end coupled to a distal portion of the valve frame and a second end extending radially outward from the first end.

[0489] Example 121: According to any example herein, specifically the prosthetic valve described in Examples 118 to 120, it further includes a plurality of proximal tensioning bodies and a plurality of distal tensioning bodies, wherein the plurality of proximal tensioning bodies extend radially outward from the proximal portion of the valve frame, and the plurality of distal tensioning bodies extend radially outward from the distal portion of the valve frame.

[0490] Example 122: The prosthetic valve of any example herein, particularly Example 121, wherein each of the plurality of proximal tensioning bodies are circumferentially spaced equidistantly from one another, and each of the plurality of distal tensioning bodies are circumferentially spaced equidistantly from one another.

[0491] Example 123: The prosthetic valve of any example herein, particularly Examples 118 to 122, wherein the distal tensioning body comprises a distal anchor for the prosthetic valve.

[0492] Example 124: The prosthetic valve of any example herein, particularly Examples 118 to 123, wherein the proximal tensioning body comprises a proximal anchor for the prosthetic valve.

[0493] Example 125: The prosthetic valve of any example herein, particularly Examples 118 to 124, wherein the proximal tensioning body comprises a ring.

[0494] Example 126: The prosthetic valve of any example herein, particularly Examples 118 to 125, wherein the distal tensioning body comprises a ring.

[0495] Example 127: The prosthetic valve of any example herein, particularly Examples 116 to 126, further comprising a plurality of wires extending along and supporting the sealing skirt.

[0496] Example 128: The prosthetic valve of any example herein, particularly Examples 116 to 127, wherein the sealing skirt is elastic and configured to deflect radially inward to conform to the shape of the native valve.

[0497] Example 129: The prosthetic valve of any example herein, particularly Examples 116 to 128, wherein the prosthetic valve comprises a single frame prosthetic valve.

[0498] Example 130: The prosthetic valve of any example herein, particularly Examples 116 to 129, wherein the prosthetic valve is configured to be deployed to the mitral valve or the tricuspid valve.

[0499] Example 131: A method comprising: deploying a prosthetic valve to a natural valve, the prosthetic valve comprising: a valve frame surrounding a flow channel; one or more prosthetic valve leaflets, the one or more prosthetic valve leaflets connected to the valve frame and extending radially inward from the valve frame and positioned within the flow channel; and a sealing skirt, the sealing skirt being positioned radially outward from the valve frame, having a certain space between the sealing skirt and the valve frame, the sealing skirt being in a tensioned state and configured to deflect to conform to the shape of the natural valve.

[0500] Example 132: The method of any example herein, particularly Example 131, wherein the sealing skirt surrounds the valve frame.

[0501] Example 133: A method according to any example herein, specifically Example 131 or Example 132, wherein: a proximal tensioning body is positioned at a proximal portion of the prosthetic valve, a distal tensioning body is positioned at a distal portion of the prosthetic valve, and wherein the sealing skirt includes a proximal end connected to the proximal tensioning body and a distal end connected to the distal tensioning body, and the sealing skirt is tensioned by the proximal tensioning body and the distal tensioning body.

[0502] Example 134: The method according to any example herein, particularly Example 133, wherein the proximal tensioning body comprises an arm having a first end coupled to the proximal portion of the valve frame and a second end extending radially outward from the first end.

[0503] Example 135: The method according to any example herein, specifically Example 133 or Example 134, wherein the distal tensioning body comprises an arm having a first end connected to the distal portion of the valve frame and a second end extending radially outward from the first end.

[0504] Example 136: According to any example described herein, specifically the method of Examples 133 to 135, wherein a plurality of proximal tensioning bodies extend radially outward from a proximal portion of the valve frame, and a plurality of distal tensioning bodies extend radially outward from a distal portion of the valve frame.

[0505] Example 137: The method according to any example herein, specifically Example 136, wherein each of the plurality of proximal tensioning bodies are equidistantly circumferentially spaced from one another, and each of the plurality of distal tensioning bodies are equidistantly circumferentially spaced from one another.

[0506] Example 138: The method of any example herein, particularly Examples 133 to 137, wherein the distal tensioning body comprises a distal anchor for the prosthetic valve.

[0507] Example 139: A prosthetic valve configured to be deployed to a natural valve, the prosthetic valve comprising: a valve frame surrounding a flow channel; one or more prosthetic valve leaflets connected to the valve frame and extending radially inward from the valve frame and positioned within the flow channel; a sealing skirt positioned radially outward from the valve frame and including a pocket; and a ring positioned in the pocket and configured to support the sealing skirt.

[0508] Example 140: The prosthetic valve of any example herein, particularly Example 139, wherein the bag comprises overlapping material of the sealing skirt.

[0509] Example 141: The prosthetic valve of any example herein, particularly Example 139 or Example 140, wherein the sealing skirt includes a proximal portion and a distal portion, and the bag is positioned at the proximal portion.

[0510] Example 142: The prosthetic valve of any example herein, particularly Example 141, further comprising one or more distal anchors, and wherein the distal portion of the sealing skirt is coupled to the one or more distal anchors.

[0511] Example 143: The prosthetic valve of any example herein, particularly Example 142, wherein each of the one or more distal anchors is configured to hook onto a distal tip of a native valve leaflet.

[0512] Example 144: The prosthetic valve of any example herein, particularly Example 142 or Example 143, wherein the distal portion of the sealing skirt is configured to slide along the one or more distal anchors.

[0513] Example 145: The prosthetic valve of any example herein, particularly Examples 139 to 144, wherein the ring includes a proximal tensioning body configured to tension the sealing skirt.

[0514] Example 146: The prosthetic valve of any example herein, particularly Examples 139 to 145, wherein the sealing skirt is in a tensioned state and is configured to deflect to conform to the shape of the native valve.

[0515] Example 147: The prosthetic valve of any example herein, particularly Examples 139 to 146, wherein the prosthetic valve comprises a single frame prosthetic valve.

[0516] Example 148: The prosthetic valve of any example herein, particularly Examples 139 to 147, wherein the prosthetic valve is configured to be deployed to the mitral valve or the tricuspid valve.

[0517] Example 149: A method comprising: deploying a prosthetic valve to a natural valve, the prosthetic valve comprising: a valve frame surrounding a flow channel; one or more prosthetic valve leaflets, the one or more prosthetic valve leaflets connected to the valve frame and extending radially inward from the valve frame and positioned within the flow channel, a sealing skirt, the sealing skirt being positioned radially outward from the valve frame and comprising a pocket, and a ring positioned in the pocket and configured to support the sealing skirt.

[0518] Example 150: The method according to any example herein, particularly Example 149, wherein the bag comprises overlapping material of the sealing skirt.

[0519] Example 151: The method according to any example herein, particularly Example 149 or Example 150, wherein the sealing skirt includes a proximal portion and a distal portion, and the bag is positioned at the proximal portion.

[0520] Example 152: The method of any example herein, particularly Example 151, wherein the distal portion of the sealing skirt is coupled to one or more distal anchors.

[0521] Example 153: The method according to any example herein, particularly Example 152, wherein each of the one or more distal anchors is configured to hook onto a distal tip of a native valve leaflet.

[0522] Example 154: The method according to any example herein, particularly Example 152 or Example 153, wherein the distal portion of the sealing skirt is configured to slide along the one or more distal anchors.

[0523] Example 155: According to any example herein, in particular the method of Examples 149 to 154, wherein the ring includes a proximal tensioning body configured to tension the sealing skirt.

[0524] Example 156: The method of any example herein, particularly Examples 149 to 155, wherein the sealing skirt is in tension and is configured to deflect to conform to the shape of the native valve.

[0525] Example 157: A prosthetic valve configured to be deployed to a natural valve, the prosthetic valve comprising: a valve frame surrounding a flow channel; one or more prosthetic valve leaflets, the one or more prosthetic valve leaflets connected to the valve frame and extending radially inward from the valve frame and positioned within the flow channel; one or more anchors, the one or more anchors configured to anchor the one or more prosthetic valve leaflets to the natural valve; a sealing skirt, the sealing skirt being positioned radially outward from the valve frame and including a distal portion; and one or more slidable connectors, the one or more slidable connectors connecting the distal portion of the sealing skirt to the one or more anchors and being configured to allow the distal portion of the sealing skirt to slide relative to the one or more anchors.

[0526] Example 158: The prosthetic valve of any example herein, particularly Example 157, wherein each of the one or more slidable connectors comprises a ring.

[0527] Example 159: The prosthetic valve of any example herein, particularly Example 158, wherein the ring surrounds a corresponding anchor of the one or more anchors and is configured to slide along the one or more anchors.

[0528] Example 160: According to any example herein, specifically the prosthetic valve described in Examples 157 to 159, each of the one or more anchors comprises a slender arm, and the one or more slidable connectors are configured to slide along the slender arm to allow the distal portion of the sealing skirt to slide relative to the one or more anchors.

[0529] Example 161: The prosthetic valve of any example herein, particularly Example 160, wherein the elongated arm includes a tip and the one or more slidable connectors are configured to slide away from the tip.

[0530] Example 162: The prosthetic valve of any example herein, specifically Example 161, wherein the elongated arm includes a protrusion positioned between the one or more slidable connectors and the tip, the protrusion being configured to overlap with the distal tip of the native valve leaflet.

[0531] Example 163: The prosthetic valve of any example herein, particularly Example 162, wherein the one or more slidable connectors are configured to slide away from the tip to increase the size of the protrusion.

[0532] Example 164: The prosthetic valve of any example herein, particularly Examples 157 to 163, wherein the sealing skirt is in a tensioned state and is configured to deflect to conform to the shape of the native valve.

[0533] Example 165: The prosthetic valve of any example herein, particularly Examples 157 to 164, wherein the prosthetic valve comprises a single frame prosthetic valve.

[0534] Example 166: The prosthetic valve of any example herein, particularly Examples 157 to 165, wherein the prosthetic valve is configured to be deployed to the mitral valve or the tricuspid valve.

[0535] Example 167: A method comprising: deploying a prosthetic valve to a natural valve, the prosthetic valve comprising: a valve frame surrounding a flow channel; one or more prosthetic valve leaflets, the one or more prosthetic valve leaflets connected to the valve frame and extending radially inward from the valve frame and positioned within the flow channel; one or more anchors, the one or more anchors configured to anchor the one or more prosthetic valve leaflets to the natural valve; a sealing skirt, the sealing skirt being positioned radially outward from the valve frame and including a distal portion; and one or more slidable connectors, the one or more slidable connectors connecting the distal portion of the sealing skirt to the one or more anchors and being configured to allow the distal portion of the sealing skirt to slide relative to the one or more anchors.

[0536] Example 168: According to any example described herein, in particular the method of Example 167, each of the one or more slidable connectors comprises a ring.

[0537] Example 169: The method according to any example herein, particularly Example 168, wherein the ring surrounds a corresponding anchor of the one or more anchors and is configured to slide along the one or more anchors.

[0538] Example 170: According to any example described herein, particularly the method described in Examples 167 to 169, wherein each of the one or more anchors comprises a slender arm, and the one or more slidable connectors are configured to slide along the slender arm to allow the distal portion of the sealing skirt to slide relative to the one or more anchors.

[0539] Example 171: According to any example herein, in particular the method of Example 170, wherein the slender arm includes a tip and the one or more slidable connectors are configured to slide away from the tip.

[0540] Example 172: The method of any example described herein, particularly Example 171, wherein the elongated arm includes a protrusion positioned between the one or more slidable connectors and the tip, the protrusion being configured to overlap with the distal tip of the native valve leaflet.

[0541] Example 173: According to any example herein, in particular the method of Example 172, wherein the one or more slidable connectors are configured to slide away from the tip to increase the size of the protrusion.

[0542] Example 174: The method of any example herein, particularly Examples 167 to 173, wherein the sealing skirt is in tension and is configured to deflect to conform to the shape of the native valve.

[0543] Example 175: A prosthetic valve configured to be deployed to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; and one or more anchors configured to anchor the one or more prosthetic valve leaflets to the native valve, each of the one or more anchors comprising a T-bar.

[0544] Example 176: The prosthetic valve of any example herein, particularly Example 175, wherein each of the one or more anchors comprises an atrial anchor.

[0545] Example 177: A prosthetic valve according to any example herein, particularly Example 175 or Example 176, wherein the valve frame supports the one or more prosthetic valve leaflets and has a proximal portion and a distal portion, and each of the one or more anchors extends radially outward from the proximal portion of the valve frame.

[0546] Example 178: The prosthetic valve of any example herein, particularly Example 177, wherein each of the T-bars comprises a rod coupled to a proximal portion of the valve frame and a crossbar extending laterally relative to the rod.

[0547] Example 179: The prosthetic valve of any example herein, particularly Example 178, wherein each of the T-shaped rods is configured such that the crossbar is positioned radially outside of the rod.

[0548] Example 180: The prosthetic valve of any example herein, particularly Example 178 or Example 179, wherein the one or more anchors include a plurality of anchors, and the crossbars of the plurality of anchors form a ring extending circumferentially around the prosthetic valve.

[0549] Example 181: The prosthetic valve of any example herein, particularly Examples 178 to 180, wherein the one or more anchors include a plurality of anchors, and the crossbars of the plurality of anchors form a segmented flange extending circumferentially around the prosthetic valve.

[0550] Example 182: The prosthetic valve of any example herein, particularly Examples 178 to 181, wherein the stem includes an undulating portion configured to provide flexibility to the stem.

[0551] Example 183: A prosthetic valve according to any example herein, specifically Examples 178 to 182, wherein the crossbar includes a central portion connected to the one or more distal anchors and a first arm and a second arm each extending outward from the central portion, the first arm and the second arm each being configured to deflect radially inward toward the rod.

[0552] Example 184: A prosthetic valve according to any example herein, specifically Examples 175 to 183, wherein each of the one or more anchors comprises a proximal anchor and the prosthetic valve further comprises one or more distal anchors, each of the one or more distal anchors being configured to hook onto a distal tip of a native valve leaflet.

[0553] Example 185: The prosthetic valve of any example herein, particularly Example 184, wherein the one or more distal anchors are positioned circumferentially between two of the proximal anchors.

[0554] Example 186: According to any example herein, specifically the prosthetic valve described in Examples 175 to 185, further comprising a sealing skirt having a proximal portion and a distal portion, wherein the one or more anchors include a proximal tensioning body connected to the proximal portion of the sealing skirt and configured to tension the sealing skirt.

[0555] Example 187: According to any example herein, specifically the prosthetic valve described in Example 186, each of the one or more anchors includes a proximal anchor and the prosthetic valve further includes one or more distal anchors, each of the one or more distal anchors including a distal tensioning body, which is connected to the distal portion of the sealing skirt and is configured to tension the sealing skirt.

[0556] Example 188: The prosthetic valve of any example herein, particularly Examples 175 to 187, wherein the prosthetic valve comprises a single frame prosthetic valve.

[0557] Example 189: The prosthetic valve of any example herein, particularly Examples 175 to 188, wherein the prosthetic valve is configured to be deployed to the mitral valve or the tricuspid valve.

[0558] Example 190: A method comprising: deploying a prosthetic valve to a natural valve, the prosthetic valve comprising: one or more prosthetic valve leaflets, and one or more anchors, the one or more anchors being configured to anchor the one or more prosthetic valve leaflets to the natural valve, each of the one or more anchors comprising a T-bar.

[0559] Example 191: The method of any example herein, particularly Example 190, wherein each of the one or more anchors comprises an atrial anchor.

[0560] Example 192: The method described in any example herein, particularly Example 190 or Example 191, wherein the valve frame supports the one or more prosthetic valve leaflets and has a proximal portion and a distal portion, and each of the one or more anchors extends radially outward from the proximal portion of the valve frame.

[0561] Example 193: The method of any example herein, particularly Example 192, wherein each of the T-bars comprises a rod coupled to a proximal portion of the valve frame and a crossbar extending transversely relative to the rod.

[0562] Example 194: According to any example herein, in particular the method of Example 193, each of the T-shaped rods is configured so that the cross bar is positioned radially outside of the rod.

[0563] Example 195: The method of any example herein, particularly Example 193 or Example 194, wherein the one or more anchors include a plurality of anchors, and the crossbars of the plurality of anchors form a ring extending circumferentially around the prosthetic valve.

[0564] Example 196: The method of any example herein, particularly Examples 193 to 195, wherein the one or more anchors include a plurality of anchors, and the crossbars of the plurality of anchors form a segmented flange extending circumferentially around the prosthetic valve.

[0565] Example 197: According to any example herein, in particular the method of Examples 193 to 196, wherein the rod includes a undulating portion configured to provide flexibility to the rod.

[0566] Example 198: A prosthetic valve configured to be deployed to a natural valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; a valve body supporting the one or more prosthetic valve leaflets; a plurality of distal anchors, each of the plurality of distal anchors comprising an elongated arm having a first end connected to the valve body and extending radially outward from the first end of the corresponding elongated arm to a tip along a certain length, each elongated arm being configured to hook onto the distal tip of the natural valve leaflet to anchor the one or more prosthetic valve leaflets to the natural valve; and a sealing skirt forming a disc extending circumferentially along the length of each of the elongated arms and between adjacent elongated arms.

[0567] Example 199: The prosthetic valve of any example herein, particularly Example 198, wherein the sealing skirt is coextensive with each of the elongated arms.

[0568] Example 200: The prosthetic valve of any example herein, particularly Example 198 or Example 199, wherein the sealing skirt extends from the first end of each of the elongated arms to the tip.

[0569] Example 201: The prosthetic valve of any example herein, particularly Examples 198 to 200, wherein the valve body comprises a frame supporting the one or more prosthetic valve leaflets.

[0570] Example 202: The prosthetic valve of any example herein, particularly Example 201, wherein the sealing skirt is coextensive with the frame.

[0571] Example 203: The prosthetic valve of any example herein, particularly examples 198 to 202, wherein the disc has a convex curvature.

[0572] Example 204: The prosthetic valve of any example herein, particularly Examples 198 to 203, wherein each of the elongated arms includes a curved portion and the disc is configured to extend along the curved portion.

[0573] Example 205: The prosthetic valve of any example herein, particularly Examples 198 to 204, wherein at least a portion of the disc is configured to be positioned radially outside of the native valve leaflets.

[0574] Example 206: The prosthetic valve of any example herein, particularly Examples 198 to 205, wherein the prosthetic valve comprises a single frame prosthetic valve.

[0575] Example 207: The prosthetic valve of any example herein, particularly Examples 198 to 206, wherein the prosthetic valve is configured to be deployed to the mitral valve or the tricuspid valve.

[0576] Example 208: A method comprising: deploying a prosthetic valve to a natural valve, the prosthetic valve comprising: one or more prosthetic valve leaflets, a valve body, the valve body supporting the one or more prosthetic valve leaflets, a plurality of distal anchors, the plurality of distal anchors each comprising a slender arm having a first end connected to the valve body and extending radially outward from the first end of the corresponding slender arm to a tip along a certain length, each slender arm being configured to hook onto the distal tip of the natural valve leaflet to anchor the one or more prosthetic valve leaflets to the natural valve, and a sealing skirt, the sealing skirt forming a disc, the disc extending circumferentially along the length of each of the slender arms and between adjacent slender arms.

[0577] Example 209: The method of any example herein, particularly Example 208, wherein the sealing skirt is coextensive with each of the elongated arms.

[0578] Example 210: The method of any example herein, particularly Example 208 or Example 209, wherein the sealing skirt extends from the first end of each of the elongated arms to the tip.

[0579] Example 211: The method of any example herein, particularly Examples 208 to 210, wherein the valve body includes a frame supporting the one or more prosthetic valve leaflets.

[0580] Example 212: The method according to any example herein, particularly Example 211, wherein the sealing skirt is coextensive with the frame.

[0581] Example 213: According to any example herein, in particular the method of Examples 208 to 212, wherein the disk has a convex curvature.

[0582] Example 214: According to any example herein, in particular the method of Examples 208 to 213, each of the elongated arms includes a curved portion and the disk is configured to extend along the curved portion.

[0583] Example 215: The method of any example herein, particularly Examples 208 to 214, wherein at least a portion of the disc is configured to be positioned radially outside of the native valve leaflets.

[0584] Example 216: A prosthetic valve configured to be deployed to a natural valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; and one or more anchors, the one or more anchors configured to anchor the one or more prosthetic valve leaflets to the natural valve, each of the one or more anchors comprising a hinge, the hinge configured to allow radial deflection of the corresponding anchor.

[0585] Example 217: The prosthetic valve of any example herein, particularly Example 216, wherein the hinge is configured to allow the corresponding anchor to deflect radially inward.

[0586] Example 218: The prosthetic valve of any example herein, particularly Example 216 or Example 217, wherein the hinge comprises a mechanical bearing hinge or a living hinge.

[0587] Example 219: The prosthetic valve of any example herein, particularly Examples 216 to 218, wherein the hinge is configured to hinder radially outward deflection of the corresponding anchor.

[0588] Example 220: The prosthetic valve of any example herein, particularly Examples 216 to 219, wherein each of the one or more anchors is configured to be in a hook configuration.

[0589] Example 221: A prosthetic valve according to any example herein, specifically Examples 216 to 220, wherein each of the one or more anchors includes a first portion and a second portion connected to the first portion, the first portion extending distally and having a convex curvature in the distal direction, and the second portion extending linearly in the proximal direction to the tip of the corresponding anchor.

[0590] Example 222: The prosthetic valve of any example herein, particularly Example 221, wherein the hinge is positioned on the second portion or at the junction of the first portion and the second portion.

[0591] Example 223: The prosthetic valve of any example herein, particularly Example 221, wherein the hinge is positioned on the first portion.

[0592] Example 224: The prosthetic valve of any example herein, particularly Examples 216 to 223, wherein each of the one or more anchors extends radially outward from a valve body supporting the one or more prosthetic valve leaflets.

[0593] Example 225: The prosthetic valve of any example herein, particularly Example 224, wherein the valve body includes a proximal portion and a distal portion, and each of the one or more anchors is coupled to the distal portion of the valve body.

[0594] Example 226: The prosthetic valve of any example herein, particularly Example 224 or Example 225, wherein the valve body includes an inner valve body and a sealing body positioned radially outside of the inner valve body.

[0595] Example 227: The prosthetic valve of any example herein, particularly Example 226, wherein the inner valve body comprises an inner frame and the sealing body comprises an outer frame.

[0596] Example 228: The prosthetic valve of any example herein, particularly Example 226 or Example 227, wherein the sealing body includes an outer frame and a sealing skirt positioned on the outer frame.

[0597] Example 229: A prosthetic valve according to any example herein, particularly Examples 226 to 228, wherein the one or more anchors each comprise an elongated arm.

[0598] Example 230: A prosthetic valve according to any example herein, specifically Examples 226 to 229, wherein the inner valve body includes a distal portion and a proximal portion, and the sealing body includes a distal portion and a proximal portion, and the proximal portion of the inner valve body is connected to the proximal portion of the sealing body.

[0599] Example 231: The prosthetic valve of any example herein, in particular Example 230, wherein the distal portion of the inner valve body is separated from the distal portion of the sealing body by a certain gap.

[0600] Example 232: The prosthetic valve of any example herein, particularly Examples 216 to 231, wherein the hinge is configured to allow the corresponding anchor to deflect radially inward in response to a radially inward force of the native valve leaflet.

[0601] Example 233: The prosthetic valve of any example herein, particularly Examples 216 to 232, wherein the hinge is configured to allow the corresponding anchor to deflect radially inward in response to contractile movement of the native valve leaflets.

[0602] Example 234: The prosthetic valve of any example herein, particularly Examples 216 to 233, wherein each of the one or more anchors is configured to extend over a distal tip of a native valve leaflet to anchor to the respective native valve leaflet.

[0603] Example 235: The prosthetic valve of any example herein, particularly Examples 216 to 234, wherein the prosthetic valve is configured to be deployed to the mitral valve or the tricuspid valve.

[0604] Example 236: A method comprising: deploying a prosthetic valve to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets, and one or more anchors, the one or more anchors configured to anchor the one or more prosthetic valve leaflets to the native valve, each of the one or more anchors comprising a hinge, the hinge configured to allow radial deflection of the corresponding anchor.

[0605] Example 237: The method according to any example herein, particularly Example 236, wherein the hinge is configured to allow the corresponding anchor to deflect radially inward.

[0606] Example 238: The method according to any example described herein, particularly Example 236 or Example 237, wherein the hinge comprises a mechanical bearing hinge or a living hinge.

[0607] Example 239: According to any example herein, in particular the method of Examples 236 to 238, wherein the hinge is configured to hinder radially outward deflection of the corresponding anchor.

[0608] Example 240: According to any example described herein, in particular the method of Examples 236 to 239, each of the one or more anchors is configured to be in a hook configuration.

[0609] Example 241: According to any example herein, specifically the method described in Examples 236 to 240, each of the one or more anchors includes a first portion and a second portion connected to the first portion, the first portion extending distally and having a convex curvature in the distal direction, and the second portion extending linearly in the proximal direction to the tip of the corresponding anchor.

[0610] Example 242: The method according to any example herein, in particular Example 241, wherein the hinge is positioned on the second part or at the junction of the first part and the second part.

[0611] Example 243: The method according to any example described herein, particularly Example 241, wherein the hinge is positioned on the first portion.

[0612] Example 244: A prosthetic valve configured to be deployed to a natural valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; an internal frame that supports the one or more prosthetic valve leaflets; an external frame that is positioned radially outward from the internal frame and surrounds the internal frame, the external frame being separated from the internal frame by a certain gap; and one or more anchors that are connected to the external frame and are each configured to be radially positioned outside of one or more leaflets of the natural valve to be anchored to the natural valve.

[0613] Example 245: The prosthetic valve of any example herein, particularly Example 244, wherein each of the one or more anchors is configured to be in a hook configuration.

[0614] Example 246: A prosthetic valve according to any example herein, particularly Example 244 or Example 245, wherein each of the one or more anchors includes a connecting portion and a tip portion, the connecting portion is connected to the external frame, and the tip portion is configured to extend proximally from the connecting portion.

[0615] Example 247: The prosthetic valve of any example herein, in particular Example 246, wherein the connecting portion has a convex curvature in the distal direction.

[0616] Example 248: The prosthetic valve of any example herein, particularly Example 246 or Example 247, wherein the tip portion is linear.

[0617] Example 249: The prosthetic valve of any example herein, particularly Examples 246 to 248, wherein the outer frame includes a distal portion, and the coupling portion is coupled to the distal portion of the outer frame.

[0618] Example 250: The prosthetic valve of any example herein, particularly Examples 246 to 249, wherein the outer frame includes a plurality of struts forming a plurality of distal apexes, and the coupling portions are coupled to corresponding distal apexes of the distal apexes.

[0619] Example 251: The prosthetic valve of any example herein, specifically Examples 246 to 250, wherein the outer frame includes a plurality of struts forming a lattice structure having a plurality of openings, and the tip portion is configured to align with a corresponding opening of the plurality of openings.

[0620] Example 252: A prosthetic valve according to any example herein, specifically Examples 244 to 251, wherein the inner frame includes a proximal portion and a distal portion, and the outer frame includes a proximal portion and a distal portion, the proximal portion of the inner frame being connected to the proximal portion of the outer frame.

[0621] Example 253: According to any example herein, in particular the prosthetic valve of Example 252, wherein the distal portion of the inner frame is separated from the distal portion of the outer frame by a certain gap.

[0622] Example 254: The prosthetic valve of any example herein, particularly Examples 244 to 253, wherein the one or more anchors are configured to clamp leaflets of the native valve between the one or more anchors and a portion of the prosthetic valve.

[0623] Example 255: The prosthetic valve of any example herein, particularly Example 254, wherein the one or more anchors are configured to clamp leaflets of the native valve between the one or more anchors and the outer frame.

[0624] Example 256: The prosthetic valve of any example herein, particularly Examples 244 to 255, wherein the inner frame has a radial thickness, and the radial thickness of the outer frame is less than the radial thickness of the inner frame.

[0625] Example 257: The prosthetic valve of any example herein, particularly Examples 244 to 256, wherein the inner frame has a radial thickness, and the radial thickness of each of the one or more anchors is less than the radial thickness of the inner frame.

[0626] Example 258: According to any example herein, in particular the prosthetic valve of Examples 244 to 257, further comprising a sealing skirt positioned on the outer frame.

[0627] Example 259: The prosthetic valve of any example herein, particularly Examples 244 to 258, wherein each of the one or more anchors is configured to be actuated to change the radial position of the corresponding anchor.

[0628] Example 260: According to any example herein, specifically the prosthetic valve of Example 259, each of the one or more anchors includes a tip portion that is configured to extend proximally when the prosthetic valve is in a curled configuration, and each of the one or more anchors is configured to be actuated to deflect the tip portion radially outward from the outer frame.

[0629] Example 261: A prosthetic valve according to any example herein, specifically Example 259 or Example 260, wherein the outer frame includes a distal portion having one or more actuator connectors for connecting to an actuator assembly, the one or more actuator connectors being configured to be pulled radially inward by the actuator assembly to deflect the one or more anchors radially outward.

[0630] Example 262: The prosthetic valve of any example herein, specifically Example 261, wherein the one or more actuator connectors include one or more eyelets configured to couple to one or more tethers of the actuator assembly.

[0631] Example 263: The prosthetic valve of any example herein, particularly Examples 244 to 262, wherein the prosthetic valve is configured to be deployed to the mitral valve or the tricuspid valve.

[0632] Example 264: A method comprising: deploying a prosthetic valve to a natural valve, the prosthetic valve comprising: one or more prosthetic valve leaflets, an internal frame, the internal frame supporting the one or more prosthetic valve leaflets, an external frame, the external frame positioned radially outward from the internal frame and surrounding the internal frame, the external frame being separated from the internal frame by a certain gap, and one or more anchors, the one or more anchors being connected to the external frame and each being configured to be radially positioned outside of one or more leaflets of the natural valve to anchor to the natural valve.

[0633] Example 265: According to any example described herein, in particular the method of Example 264, wherein each of the one or more anchors is configured to be in a hook configuration.

[0634] Example 266: According to any example described herein, specifically the method described in Example 264 or Example 265, each of the one or more anchors includes a connecting portion and a tip portion, the connecting portion is connected to the external frame, and the tip portion is configured to extend proximally from the connecting portion.

[0635] Example 267: According to any example described herein, in particular the method of Example 266, wherein the connecting portion has a convex curvature in the distal direction.

[0636] Example 268: According to any example described herein, specifically the method of Example 266 or Example 267, wherein the tip portion is linear.

[0637] Example 269: According to any example herein, in particular the method described in Examples 266 to 268, wherein the outer frame includes a distal portion, and the connecting portion is connected to the distal portion of the outer frame.

[0638] Example 270: According to any example herein, in particular the method described in Examples 266 to 269, wherein the outer frame includes a plurality of struts forming a plurality of distal vertices, and the connecting portions are connected to corresponding distal vertices of the distal vertices.

[0639] Example 271: According to any example herein, specifically the method described in Examples 266 to 270, wherein the outer frame includes a plurality of struts forming a lattice structure having a plurality of openings, and the tip portion is configured to align with a corresponding opening of the plurality of openings.

[0640] Example 272: A prosthetic valve configured to be deployed to a natural valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; and a frame, the frame comprising an outer frame and an inner frame, the outer frame and the inner frame being cut from a single piece of material such that the outer frame is integral with the inner frame, the outer frame deflecting radially outward from the inner frame and comprising a plurality of struts defining a plurality of openings, the inner frame being configured to support the one or more prosthetic valve leaflets and comprising a plurality of struts defining a plurality of openings, and at least a portion of the inner frame being aligned within at least one of the plurality of openings of the outer frame, or at least a portion of the outer frame being aligned within at least one of the plurality of openings of the inner frame.

[0641] Example 273: A prosthetic valve according to any example herein, specifically Example 272, wherein the frame is configured to expand radially outward from a curled configuration to an expanded configuration, the inner frame and the outer frame each have a cylindrical shape in the curled configuration, and the outer frame has an hourglass shape in the expanded configuration.

[0642] Example 274: The prosthetic valve of any example herein, specifically Example 273, wherein the inner frame has a cylindrical shape in the expanded configuration.

[0643] Example 275: The prosthetic valve of any example herein, particularly Example 273 or Example 274, wherein at least a portion of the inner frame is configured to be positioned within at least one of the plurality of openings of the outer frame when the frame is in the crimped configuration.

[0644] Example 276: The prosthetic valve of any example herein, specifically Examples 273 to 275, wherein at least a portion of the outer frame is configured to be positioned within at least one of the plurality of openings of the inner frame when the frame is in the crimped configuration.

[0645] Example 277: According to any example herein, specifically the prosthetic valve described in Examples 272 to 276, wherein the plurality of struts of the outer frame form a plurality of closed strut units, and at least a portion of the inner frame is aligned within at least one of the plurality of closed strut units.

[0646] Example 278: According to any example herein, specifically the prosthetic valve described in Examples 272 to 277, wherein the plurality of struts of the outer frame form a plurality of open strut units, and at least a portion of the inner frame is aligned within at least one of the plurality of open strut units.

[0647] Example 279: According to any example herein, in particular the prosthetic valve described in Examples 272 to 278, wherein the plurality of struts of the outer frame form a plurality of strut units each having a diamond shape.

[0648] Example 280: According to any example herein, in particular the prosthetic valve described in Examples 272 to 279, wherein the plurality of struts of the inner frame form a plurality of strut units each having a diamond shape.

[0649] Example 281: A prosthetic valve according to any example herein, specifically Examples 272 to 280, wherein the plurality of struts of the outer frame form diamond-shaped strut units, and the plurality of struts of the inner frame form diamond-shaped strut units aligned within the diamond-shaped strut units of the outer frame.

[0650] Example 282: A prosthetic valve according to any example herein, specifically Examples 272 to 281, wherein the plurality of struts of the inner frame form diamond-shaped strut units, and the plurality of struts of the outer frame form diamond-shaped strut units aligned within the diamond-shaped strut units of the inner frame.

[0651] Example 283: According to any example herein, in particular the prosthetic valve described in Examples 272 to 282, the plurality of struts of the inner frame form at least three diamond-shaped strut units that are each circumferentially spaced apart from one another.

[0652] Example 284: A prosthetic valve according to any example herein, specifically Examples 272 to 283, wherein the outer frame includes a proximal portion, a distal portion, and a central portion, and the proximal portion is configured to expand radially outward from the central portion, and the distal portion is configured to expand radially outward from the central portion.

[0653] Example 285: The prosthetic valve of any example herein, particularly Example 284, wherein the outer frame is configured to clamp a portion of a heart between the proximal portion and the distal portion to anchor the frame to the heart.

[0654] Example 286: The prosthetic valve of any example herein, particularly Examples 272 to 285, wherein the outer frame is configured to anchor the frame to the native valve.

[0655] Example 287: The prosthetic valve of any example herein, specifically Examples 272 to 286, further comprising one or more anchors coupled to the outer frame and configured to form hooks for anchoring to the native valve.

[0656] Example 288: The prosthetic valve of any example herein, specifically Examples 272 to 287, further comprising one or more anchors coupled to the inner frame and configured to form hooks for anchoring to the native valve.

[0657] Example 289: According to any example herein, in particular the prosthetic valve described in Examples 272 to 288, further comprising one or more anchors connected to the outer frame or the inner frame and configured to form hooks for clamping leaflets of the native valve.

[0658] Example 290: The prosthetic valve of any example herein, particularly Examples 272 to 289, further comprising a sealing skirt positioned on the outer frame.

[0659] Example 291: The prosthetic valve of any example herein, particularly Examples 272 to 290, wherein the prosthetic valve is configured to be deployed to the mitral valve or the tricuspid valve.

[0660] Example 292: A method comprising: deploying a prosthetic valve to a natural valve, the prosthetic valve comprising: one or more prosthetic valve leaflets, a frame, the frame comprising an outer frame and an inner frame, the outer frame and the inner frame being cut from a single piece of material such that the outer frame is integral with the inner frame, the outer frame deflects radially outward from the inner frame and comprises a plurality of struts defining a plurality of openings, the inner frame being configured to support the one or more prosthetic valve leaflets and comprises a plurality of struts defining a plurality of openings, and at least a portion of the inner frame being aligned within at least one of the plurality of openings of the outer frame, or at least a portion of the outer frame being aligned within at least one of the plurality of openings of the inner frame.

[0661] Example 293: According to any example described herein, specifically the method described in Example 292, wherein the frame is configured to expand radially outward from a curled configuration to an expanded configuration, the inner frame and the outer frame each have a cylindrical shape in the curled configuration, and the outer frame has an hourglass shape in the expanded configuration.

[0662] Example 294: According to any example herein, in particular the method of Example 293, wherein the internal frame has a cylindrical shape in the expanded configuration.

[0663] Example 295: According to any example described herein, specifically the method of Example 293 or Example 294, wherein at least a portion of the inner frame is configured to be positioned within at least one of the plurality of openings of the outer frame when the frame is in the curled configuration.

[0664] Example 296: According to any example herein, specifically the method of Examples 293 to 295, at least a portion of the outer frame is configured to be positioned within at least one of the plurality of openings of the inner frame when the frame is in the curled configuration.

[0665] Example 297: According to any example herein, specifically the method described in Examples 292 to 296, wherein the plurality of struts of the outer frame form a plurality of closed strut units, and at least a portion of the inner frame is aligned within at least one of the plurality of closed strut units.

[0666] Example 298: According to any example herein, in particular the method described in Examples 292 to 297, wherein the plurality of struts of the outer frame form a plurality of open strut units, and at least a portion of the inner frame is aligned within at least one of the plurality of open strut units.

[0667] Example 299: According to any example described herein, in particular the method of Examples 292 to 298, wherein the plurality of struts of the outer frame form a plurality of strut units each having a diamond shape.

[0668] Example 300: The method of any example herein, particularly Examples 292 to 299, wherein the prosthetic valve is configured to be deployed to a mitral valve or a tricuspid valve.

[0669] According to any example herein, including but not limited to any one of the features described in any one of the first to the 300th examples mentioned above is applicable to all other aspects and examples identified herein, including but not limited to any one of the first to the 300th examples mentioned above. In addition, the examples of each example, including but not limited to any one of the features of any one of the first to the 300th examples mentioned above can be independently combined partially or completely with other examples described herein in any way, for example, one, two or three or more examples can be combined as a whole or in part. In addition, each example, including but not limited to any one of the features of any one of the first to the 300th examples mentioned above can make other examples optional. Any example of the method can be performed by the system or equipment of another example, and any aspect or example of the system or equipment can be configured to perform another aspect or example, including but not limited to the method of any example described in any one of the first to the 300th examples mentioned above.

[0670] Finally, it should be understood that although various aspects of this specification are highlighted by reference to specific examples, it will be readily understood by those skilled in the art that these disclosed examples are merely illustrations of the principles of the subject matter disclosed herein. Therefore, it should be understood that the disclosed subject matter is by no means limited to the specific methods, schemes and / or reagents described herein, etc. Therefore, without departing from the spirit of this specification, various modifications or changes or alternative configurations can be made to the disclosed subject matter according to the teachings of this article. Finally, the terms used herein are only used for the purpose of describing specific examples and are not intended to limit the scope of the systems, devices and methods disclosed herein, which are limited only by the claims. Therefore, the systems, devices and methods are not limited to the precise content as shown and described.

[0671] Certain examples of systems, devices, and methods are described herein, including the best modes known to the inventors for performing these examples. Of course, after reading the foregoing description, variations to these described examples will become apparent to those of ordinary skill in the art. The inventors expect that skilled technicians will appropriately adopt such variations, and the inventors intend to practice systems, devices, and methods with systems, devices, and methods different from those specifically described herein. Therefore, the systems, devices, and methods include all modifications and equivalents of the subject matter described in the appended claims as permitted by applicable law. In addition, unless otherwise specified herein or clearly contradictory to the context, systems, devices, and methods encompass any combination of the above examples in all possible variations thereof.

[0672] The grouping of alternative examples, elements or steps of the systems, devices and methods should not be construed as limiting. Each group member may be referenced and claimed individually or in any combination with other group members disclosed herein. For the purpose of convenience and / or patentability, it is expected that one or more members of a group may be included in or deleted from the group. When any such inclusion or deletion is made, the specification is deemed to contain the modified group, thereby satisfying the written description of all Markush groups used in the appended claims.

[0673] Unless otherwise indicated, all numbers expressing features, items, amounts, parameters, properties, terms and the like used in the specification and claims are to be understood as being modified in all instances by the term “about.” As used herein, the term “about” means that the feature, item, amount, parameter, property or term so defined encompasses approximate values ​​that may vary but are capable of performing the desired operation or process discussed herein.

[0674] Unless otherwise specified herein or clearly contradicted by context, the terms "a", "an", "the" and similar indicators used in the context of describing systems, devices and methods (particularly in the context of the following claims) should be interpreted to cover both the singular and the plural. Unless otherwise specified herein or clearly contradicted by context in other ways, all methods described herein can be performed in any suitable order. The use of any and all examples or exemplary language (e.g., "such as") provided herein is intended only to better illustrate the systems, devices and methods and does not limit the scope of the claimed systems, devices and methods. No language in this specification should be interpreted as indicating any unclaimed element that is essential to the practice of the systems, devices and methods.

[0675] All patents, patent publications and other publications cited and identified in this specification are individually and explicitly incorporated herein by reference in their entirety for the purpose of describing and disclosing compositions and methods that may be used in combination with systems, devices and methods, such as those described in such publications. These publications are provided solely for the purpose of providing the disclosures prior to the filing date of this application. Nothing in this regard should be construed as an admission that the inventor has the right to precede such disclosures by virtue of prior inventions or for any other reason. All statements about the dates or contents of these documents are based on 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. A prosthetic valve for deployment to a native valve, the prosthetic valve comprising: a valve frame surrounding the flow passage; one or more prosthetic valve leaflets coupled to and extending radially inwardly from the valve frame and positioned within the flow channel; a proximal tensioning body positioned at a proximal portion of the prosthetic valve; a distal tensioning body positioned at a distal portion of the prosthetic valve; as well as A sealing skirt, the sealing skirt includes a proximal portion and a distal portion, and is positioned radially outward from the valve frame with a certain space between the sealing skirt and the valve frame, the proximal portion of the sealing skirt is connected to the proximal tensioning body, and the distal portion of the sealing skirt is connected to the distal tensioning body, the sealing skirt is tensioned by the proximal tensioning body and the distal tensioning body, and can be deflected to conform to the shape of the natural valve.

2. The prosthetic valve of claim 1, wherein the sealing skirt surrounds the valve frame.

3. A prosthetic valve according to claim 1 or claim 2, wherein the sealing skirt is elastic and is configured to deflect radially inward to conform to the shape of the native valve.

4. The prosthetic valve of any one of claims 1 to 3, wherein the proximal tensioning body comprises an arm having a first end coupled to a proximal portion of the valve frame and a second end extending radially outward from the first end.

5. The prosthetic valve of any one of claims 1 to 4, wherein the distal tensioning body comprises an arm having a first end coupled to a distal portion of the valve frame and a second end extending radially outward from the first end.

6. The prosthetic valve according to any one of claims 1 to 5, further comprising a plurality of proximal tensioning bodies and a plurality of distal tensioning bodies, wherein the plurality of proximal tensioning bodies extend radially outward from a proximal portion of the valve frame, and the plurality of distal tensioning bodies extend radially outward from a distal portion of the valve frame.

7. The prosthetic valve of claim 6, wherein each of the plurality of proximal tensioning bodies are circumferentially spaced equally from one another, and each of the plurality of distal tensioning bodies are circumferentially spaced equally from one another.

8. The prosthetic valve of any one of claims 1 to 7, wherein the distal tensioning body comprises a distal anchor for the prosthetic valve.

9. The prosthetic valve of any one of claims 1 to 8, wherein the proximal tensioning body comprises a ring.

10. The prosthetic valve of any one of claims 1 to 9, wherein the prosthetic valve is a mitral prosthetic valve or a tricuspid prosthetic valve.

11. A prosthetic valve for deployment to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; a frame supporting the one or more prosthetic valve leaflets; and One or more anchors are coupled to the frame and are each adapted to anchor the one or more prosthetic valve leaflets to the native valve, each of the one or more anchors comprising a hinge adapted to permit radial deflection of the respective anchor.

12. The prosthetic valve of claim 11, wherein the hinge is adapted to allow the respective anchor to deflect radially inwardly.

13. A prosthetic valve according to claim 11 or claim 12, wherein the hinge comprises a mechanical bearing hinge or a living hinge.

14. The prosthetic valve of any one of claims 11 to 13, wherein the hinge is adapted to resist radially outward deflection of the respective anchor.

15. The prosthetic valve of any one of claims 11 to 14, wherein each of the one or more anchors comprises a hook.

16. A prosthetic valve configured to be deployed to a native valve, the prosthetic valve comprising: one or more prosthetic valve leaflets; an internal frame supporting the one or more prosthetic valve leaflets; an outer frame located radially outward from the inner frame and surrounding the inner frame, the outer frame having a proximal end portion and a distal end portion and being separated from the inner frame by a gap; and One or more anchors are coupled to the distal portion of the outer frame and are each configured to be positioned radially outward of one or more leaflets of the native valve for anchoring to the native valve.

17. The prosthetic valve of claim 16, wherein each of the one or more anchors comprises a hook.

18. A prosthetic valve according to claim 16 or claim 17, wherein each of the one or more anchors includes a connecting portion and a tip portion, the connecting portion is connected to the outer frame, and the tip portion is formed to extend proximally from the connecting portion.

19. The prosthetic valve of claim 18, wherein the coupling portion has a convex curvature in a distal direction.

20. The prosthetic valve of claim 18 or claim 19, wherein the outer frame includes a plurality of struts forming a plurality of distal apices, and the coupling portions are coupled to respective ones of the distal apices.

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