Prosthetic valve for deployment

Abstract

Devices, systems, and methods for prosthetic valves. Utilizing the prosthetic valves disclosed herein may improve deployment, sealing, and anchoring to an implantation site. The implantation site may include a native heart valve, or in examples, another implantation site. An example prosthetic valve may include a proximal tensioning body disposed at a proximal portion of the prosthetic valve and a distal tensioning body disposed 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 and distal tensioning bodies and may be deflectable to conform to the shape of the native valve.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 328,638, filed April 7, 2022, the entire contents of which are incorporated herein by reference.

[0002] Certain features in the present disclosure relate generally to implants, including prosthetic valves, for deployment. [Background technology]

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

[0004] Prosthetic valves exist to correct problems associated with dysfunctional heart valves. For example, mechanical tissue-based prosthetic heart valves can be used to replace dysfunctional native heart valves. Recently, there has been a great deal of effort in developing replacement heart valves, particularly tissue-based replacement heart valves that can be delivered less traumatically to the patient compared to open-heart surgery. Replacement valves are designed to be delivered by minimally invasive procedures, and even percutaneous procedures.

[0005] Such replacement valves are typically intended to replace the function of a natural valve by blocking blood flow in a first direction and allowing blood flow freely in a second direction. However, problems arise when blood leaks outside the replacement valve. For example, in the context of replacement heart valves, paravalvular leakage (PVL) has proven to be a particular challenge. An additional challenge relates to the ability to fix such prosthetic valves to intraluminal tissue, for example, to tissue in any body cavity or cavity, in an atraumatous manner. Summary of the Invention

[0006] The prosthetic valve examples disclosed herein may be directed to improvements in prosthetic valves. Such prosthetic valves may include, in examples, replacement heart valves. Examples may be utilized to improve anchoring and sealing with respect to flow (e.g., paravalvular leakage) outside the flow channel of the prosthetic valve. Various other improvements have been disclosed.

[0007] Examples may be directed to a prosthetic valve configured to be deployed relative to a native valve, which may include one or more prosthetic leaflets, a seal body disposed radially outward of the one or more prosthetic leaflets and configured to seal against a portion of the native valve, one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, and one or more magnets configured to attract the seal body and at least one of the one or more anchors to one another.

[0008] Examples may be directed to a method, which may include deploying a prosthetic valve relative to a native valve, which may include one or more prosthetic leaflets, a seal body disposed radially outward of the one or more prosthetic leaflets and configured to seal against a portion of the native valve, one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, and one or more magnets configured to attract the seal body and at least one of the one or more anchors to one another.

[0009] Examples may be directed to a prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve may include one or more prosthetic leaflets and one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, each of the one or more anchors including one or more grooves configured to increase flexibility of the respective anchor.

[0010] Examples may be directed to a method, which may include deploying a prosthetic valve relative to a native valve, the prosthetic valve may include one or more prosthetic leaflets and one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, each of the one or more anchors including one or more grooves configured to increase flexibility of the respective anchor.

[0011] Examples may be directed to a prosthetic valve configured to be deployed relative to a native valve. The prosthetic valve may include one or more prosthetic leaflets and one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, each of the one or more anchors including a coil.

[0012] Examples may be directed to a method. The method may include deploying a prosthetic valve relative to a native valve. The prosthetic valve may include one or more prosthetic leaflets and one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, each of the one or more anchors including a coil.

[0013] Examples may be directed to a prosthetic valve configured to be deployed relative to a native valve, which may include a valve body enclosing a flow channel extending along a longitudinal dimension, one or more prosthetic leaflets extending radially inward from the valve body and disposed within the flow channel, and one or more anchors pivotally coupled to the valve body, the one or more anchors configured to pivot about the longitudinal dimension to vary the radial distance of the one or more anchors from the valve body.

[0014] Examples may be directed to a method, which may include deploying a prosthetic valve relative to a native valve, which may include a valve body enclosing a flow channel extending along a longitudinal dimension, one or more prosthetic leaflets extending radially inward from the valve body and disposed within the flow channel, and one or more anchors pivotally coupled to the valve body, the one or more anchors configured to pivot about the longitudinal dimension to vary a radial distance of the one or more anchors from the valve body.

[0015] Examples may be directed to a prosthetic valve configured to be deployed relative to a native valve, which may include one or more prosthetic leaflets, a sealing body disposed radially outward of the one or more prosthetic leaflets and configured to seal against a portion of the native valve, one or more anchors configured to anchor the one or more prosthetic leaflets relative to the native valve, and a band configured to have an adjustable diameter to move the sealing body radially inward or radially outward.

[0016] Examples may be directed to a method, which may include deploying a prosthetic valve relative to a native valve, which may include one or more prosthetic leaflets, a seal body disposed radially outward of the one or more prosthetic leaflets, the seal body configured to seal against a portion of the native valve, one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, and a band configured to have an adjustable diameter to move the seal body radially inward or radially outward.

[0017] Examples may be directed to a prosthetic valve configured to be deployed relative to a native valve, which may include a valve frame surrounding a flow channel, one or more prosthetic leaflets coupled to the valve frame, the one or more prosthetic leaflets extending radially inward from the valve frame and disposed within the flow channel, and a sealing skirt disposed radially outward from the valve frame with a space between them, the sealing skirt being in tension and configured to flex to conform to a shape of the native valve.

[0018] Examples may be directed to a method, which may include deploying a prosthetic valve relative to a native valve, the prosthetic valve may include a valve frame surrounding a flow channel, one or more prosthetic leaflets coupled to the valve frame, the one or more prosthetic leaflets extending radially inward from the valve frame and disposed within the flow channel, and a sealing skirt disposed 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 flex to conform to a shape of the native valve.

[0019] Examples may be directed to a prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve may include a valve frame surrounding a flow channel, one or more prosthetic leaflets coupled to the valve frame, the one or more prosthetic leaflets extending radially inward from the valve frame and disposed within the flow channel, a sealing skirt disposed radially outward from the valve frame, the sealing skirt including a pocket, and a ring disposed within the pocket, the ring configured to support the sealing skirt.

[0020] Examples may be directed to a method. The method may include deploying a prosthetic valve relative to a native valve. The prosthetic valve may include a valve frame surrounding a flow channel, one or more prosthetic leaflets coupled to the valve frame, the one or more prosthetic leaflets extending radially inward from the valve frame and disposed within the flow channel, a seal skirt disposed radially outward from the valve frame, the seal skirt including a pocket, and a ring disposed in the pocket, the ring configured to support the seal skirt.

[0021] Examples may be directed to a prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve may include a valve frame surrounding a flow channel, one or more prosthetic leaflets coupled to the valve frame, the one or more prosthetic leaflets extending radially inward from the valve frame and disposed within the flow channel, one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, a sealing skirt disposed radially outward from the valve frame, the sealing skirt including a distal portion, and one or more slidable couplers coupling the distal portion of the sealing skirt to the one or more anchors, the one or more slidable couplers configured to allow the distal portion of the sealing skirt to slide relative to the one or more anchors.

[0022] Examples may be directed to a method, which may include deploying a prosthetic valve relative to a native valve. The prosthetic valve may include a valve frame surrounding a flow channel, one or more prosthetic leaflets coupled to the valve frame, the one or more prosthetic leaflets extending radially inward from the valve frame and disposed within the flow channel, one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, a sealing skirt disposed radially outward from the valve frame, the sealing skirt including a distal portion, and one or more slidable couplers coupling a distal portion of the sealing skirt to the one or more anchors, the one or more slidable couplers configured to allow the distal portion of the sealing skirt to slide relative to the one or more anchors.

[0023] Examples may be directed to a prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve may include one or more prosthetic leaflets and one or more anchors configured to anchor the one or more prosthetic leaflets relative to the native valve, each anchor including a T-bar.

[0024] Examples may be directed to a method. The method may include deploying a prosthetic valve relative to a native valve. The prosthetic valve may include one or more prosthetic leaflets and one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, each anchor including a T-bar.

[0025] Examples may be directed to a prosthetic valve configured to be deployed against a native valve, the prosthetic valve may include one or more prosthetic leaflets, a valve body supporting the one or more prosthetic leaflets, a plurality of distal anchors, each including a long arm having a first end coupled to the valve body and extending radially outward along a length from the first end to a tip of a respective long arm, each long arm configured to hook onto a distal tip of a native leaflet to anchor the one or more prosthetic leaflets against the native valve, and a sealing skirt forming a disk, the disk extending along the length of each long arm and extending circumferentially between adjacent long arms.

[0026] Examples may be directed to a method, which may include deploying a prosthetic valve relative to a native valve, the prosthetic valve may include one or more prosthetic leaflets, a valve body supporting the one or more prosthetic leaflets, a plurality of distal anchors, each including a long arm having a first end coupled to the valve body and extending radially outward along a length from the first end to a tip of a respective long arm, each long arm configured to hook onto a distal tip of a native leaflet to anchor the one or more prosthetic leaflets to the native valve, and a sealing skirt forming a disk, the disk extending along a length of each long arm and extending circumferentially between adjacent long arms.

[0027] Examples may be directed to a prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve may include one or more prosthetic leaflets and one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, each of the one or more anchors including a hinge configured to allow a respective corresponding anchor to flex radially.

[0028] Examples may be directed to a method, which may include deploying a prosthetic valve relative to a native valve, the prosthetic valve including one or more prosthetic leaflets and one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, each of the one or more anchors including a hinge configured to allow a respective corresponding anchor to flex radially.

[0029] Examples may be directed to a prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve may include one or more prosthetic leaflets, an inner frame supporting the one or more prosthetic leaflets, an outer frame disposed radially outward from and surrounding the inner frame, the outer frame disposed at a gap from the inner frame, and one or more anchors coupled to the outer frame, each anchor configured to be disposed radially outward from one or more leaflets of the native valve to anchor to the native valve.

[0030] Examples may be directed to a method that may include deploying a prosthetic valve relative to a native valve, the prosthetic valve including one or more prosthetic leaflets, an inner frame supporting the one or more prosthetic leaflets, an outer frame disposed radially outward from the inner frame and surrounding the inner frame, the outer frame disposed at a gap from the inner frame, and one or more anchors coupled to the outer frame, each anchor configured to be disposed radially outward from one or more leaflets of the native valve to anchor to the native valve.

[0031] Examples may be directed to a prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve may include one or more prosthetic leaflets and a frame including an outer frame and an inner frame, the outer frame being cut from a single piece of material such that the outer frame is integral to the inner frame, the outer frame being biased radially outward from the inner frame and including a plurality of struts surrounding a plurality of openings, the inner frame being configured to support one or more prosthetic leaflets and including a plurality of struts surrounding 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 alternatively, at least a portion of the outer frame being aligned within at least one of the plurality of openings of the inner frame.

[0032] Examples may be directed to a method, which may include deploying a prosthetic valve relative to a native valve, the prosthetic valve including one or more prosthetic leaflets and a frame including an outer frame and an inner frame, the outer frame and the inner frame cut from a single piece of material such that the outer frame is integral to the inner frame, the outer frame being biased radially outwardly from the inner frame and including a plurality of struts surrounding a plurality of openings, the inner frame being configured to support the one or more prosthetic leaflets and including a plurality of struts surrounding 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 alternatively, at least a portion of the outer frame being aligned within at least one of the plurality of openings of the inner frame.

[0033] Any feature in the examples disclosed herein is applicable to all other aspects and examples as specified herein. Moreover, any feature in one example in the various examples may be independently combinable in any manner with other examples described herein, in part or in whole, e.g., one, two, three or more examples may be combined in whole or in part. Furthermore, any feature in an example may be optional with respect to other aspects or examples. Any example relating to a method may be performed by a system or device in another example, and any example relating to a system or device may be configured to perform a method in another example.

[0034] The features and advantages of the systems, apparatus, and methods disclosed herein will become apparent as they become more clearly understood with reference to the specification, claims, and accompanying drawings. [Brief description of the drawings]

[0035] [Figure 1] FIG. 1 illustrates a top perspective view of a prosthetic valve according to an example of the present disclosure. [Diagram 2] FIG. 2 illustrates a perspective view from below of the prosthetic valve shown in FIG. [Diagram 3] FIG. 3 illustrates a schematic cross-sectional side view of the prosthetic valve shown in FIG. [Figure 4] FIG. 4 illustrates a schematic diagram of the delivery device approaching the implantation site. [Diagram 5] FIG. 5 illustrates a schematic cross-sectional side view of the prosthetic valve shown in FIG. 1 positioned within a delivery device. [Figure 6] FIG. 6 illustrates a schematic cross-sectional side view of the prosthetic valve shown in FIG. 1 being deployed relative to a native heart valve. [Figure 7] FIG. 7 illustrates a schematic cross-sectional side view of the prosthetic valve shown in FIG. 1 deployed relative to the native heart valve. [Figure 8]FIG. 8 illustrates a detailed view of the magnetic attraction force between the anchor and the seal body shown in FIG. [Figure 9] FIG. 9 illustrates a side cross-sectional view of the anchor. [Figure 10] FIG. 10 illustrates a cross-sectional side view of the anchor. [Figure 11] FIG. 11 illustrates a side view of the anchor. [Figure 12] FIG. 12 illustrates a side cross-sectional view of the anchor shown in FIG. [Figure 13] FIG. 13 illustrates a cross-sectional view taken along line AA shown in FIG. [Figure 14] FIG. 14 illustrates a perspective view of the prosthetic valve. [Figure 15] FIG. 15 illustrates a cross-sectional view from above of the prosthetic valve shown in FIG. [Figure 16] FIG. 16 illustrates a cross-sectional view from above of the prosthetic valve shown in FIG. [Figure 17] FIG. 17 illustrates a cross-sectional view from above of the prosthetic valve shown in FIG. 14, with the native leaflets shown in dashed lines. [Figure 18] FIG. 18 illustrates a cross-sectional view from above of the prosthetic valve. [Figure 19] FIG. 19 illustrates a side cross-sectional view of the locking member. [Figure 20] FIG. 20 illustrates a side cross-sectional view of the locking member shown in FIG. [Figure 21] FIG. 21 illustrates a perspective view of the prosthetic valve. [Figure 22] FIG. 22 illustrates a perspective, partial cross-sectional view of the prosthetic valve. [Diagram 23] FIG. 23 illustrates a perspective, partial cross-sectional view of the prosthetic valve shown in FIG. [Figure 24] FIG. 24 illustrates a cross-sectional view from above of the prosthetic valve shown in FIG. [Diagram 25] FIG. 25 illustrates a plan view of the band. [Figure 26] FIG. 26 illustrates a schematic diagram of a portion of a band. [Figure 27] FIG. 27 illustrates a side cross-sectional view of the prosthetic valve. [Figure 28] FIG. 28 illustrates a side cross-sectional view of the prosthetic valve shown in FIG. 27 displaced from the position shown in FIG. [Figure 29] FIG. 29 illustrates a perspective view of the prosthetic valve shown in FIG. [Diagram 30] FIG. 30 illustrates a side cross-sectional view of the prosthetic valve shown in FIG. 27 deployed relative to the native heart valve. [Diagram 31] FIG. 31 illustrates a perspective view of the prosthetic valve. [Diagram 32] FIG. 32 illustrates a side cross-sectional view of the prosthetic valve shown in FIG. [Diagram 33] FIG. 33 illustrates a perspective view of the prosthetic valve. [Diagram 34] FIG. 34 illustrates a perspective view of the prosthetic valve. [Diagram 35] FIG. 35 illustrates a perspective view of the prosthetic valve. [Diagram 36] FIG. 36 illustrates a side cross-sectional view of the prosthetic valve. [Figure 37] FIG. 37 illustrates a top view of the ring. [Figure 38] FIG. 38 illustrates a side cross-sectional view of the prosthetic valve. [Figure 39] FIG. 39 illustrates a side cross-sectional view of the prosthetic valve. [Diagram 40] FIG. 40 illustrates a side cross-sectional view of a slidable coupler being slid along an anchor. [Diagram 41] FIG. 41 illustrates a side cross-sectional view of a slidable coupler being slid along an anchor. [Diagram 42] FIG. 42 illustrates a side cross-sectional view of the prosthetic valve. [Diagram 43] FIG. 43 illustrates a schematic plan view of the prosthetic valve shown in FIG. [Diagram 44] FIG. 44 illustrates a side view of the prosthetic valve shown in FIG. 42 deployed relative to an implantation site. [Diagram 45] FIG. 45 illustrates a perspective view of the prosthetic valve. [Figure 46] FIG. 46 illustrates a perspective view of the anchors in the prosthetic valve shown in FIG. [Figure 47] FIG. 47 illustrates a schematic plan view of the prosthetic valve shown in FIG. [Figure 48] FIG. 48 illustrates a top view of the anchor shown in FIG. [Figure 49] FIG. 49 illustrates a top view of the anchor shown in FIG. [Figure 50] FIG. 50 illustrates a top view of the anchor. [Figure 51] FIG. 51 illustrates a schematic plan view of a portion of a prosthetic valve. [Figure 52] FIG. 52 illustrates a perspective view of a portion of the prosthetic valve shown in FIG. [Diagram 53] FIG. 53 illustrates a cross-sectional perspective view of the prosthetic valve. [Figure 54] FIG. 54 illustrates a side cross-sectional view of the prosthetic valve shown in FIG. 53 deployed relative to an implantation site. [Figure 55] 55A and 55B each illustrate a cross-sectional side view of the anchor. [Figure 56] FIG. 56 illustrates a side cross-sectional view of the anchor. [Figure 57] FIG. 57 illustrates a schematic cross-sectional side view of a prosthetic valve positioned within a delivery device. [Figure 58] FIG. 58 illustrates a schematic cross-sectional side view of the prosthetic valve shown in FIG. 57 being deployed relative to the native heart valve. [Figure 59] FIG. 59 illustrates a schematic cross-sectional side view of the prosthetic valve shown in FIG. 57 being deployed relative to the native heart valve. [Figure 60]FIG. 60 illustrates a schematic cross-sectional side view of the prosthetic valve shown in FIG. 57 being deployed relative to the native heart valve. [Figure 61] FIG. 61 illustrates a schematic cross-sectional side view of the prosthetic valve shown in FIG. 57 being deployed relative to the native heart valve. [Figure 62] FIG. 62 illustrates a schematic cross-sectional side view of the prosthetic valve shown in FIG. 57 deployed relative to the native heart valve. [Figure 63] FIG. 63 illustrates a side view of the inner frame. [Figure 64] FIG. 64 illustrates a side view of the outer frame. [Figure 65] FIG. 65 illustrates a perspective view of the outer frame shown in FIG. 64 coupled to the inner frame shown in FIG. [Figure 66] FIG. 66 illustrates a side view of the outer frame shown in FIG. 64 joined to the inner frame shown in FIG. [Figure 67] FIG. 67 illustrates a top view of the outer frame shown in FIG. 64 joined to the inner frame shown in FIG. [Figure 68] FIG. 68 illustrates a schematic cross-sectional side view of a prosthetic valve deployed relative to a native heart valve. [Figure 69] FIG. 69 illustrates a side cross-sectional view of the anchor and a portion of the prosthetic valve. [Figure 70] FIG. 70 illustrates a side cross-sectional view of the anchor shown in FIG. 69 anchored to the native leaflets. [Figure 71] FIG. 71 illustrates a perspective view of the outer frame. [Figure 72] FIG. 72 illustrates a schematic cross-sectional side view of a portion of the outer frame shown in FIG. [Figure 73] FIG. 73 illustrates a schematic cross-sectional side view of a prosthetic valve positioned within a delivery device. [Figure 74] FIG. 74 illustrates a schematic cross-sectional side view of a prosthetic valve being deployed from a delivery device. [Figure 75] FIG. 75 illustrates a schematic cross-sectional side view of a prosthetic valve being deployed from a delivery device. [Figure 76] FIG. 76 illustrates a schematic cross-sectional side view of the prosthetic valve shown in FIG. 73 deployed relative to the native heart valve. [Figure 77] FIG. 77 illustrates a perspective view of the frame. [Figure 78] FIG. 78 illustrates a perspective view of the frame shown in FIG. 77 rotated from the position shown in FIG. [Figure 79] FIG. 79 illustrates a side view of the frame shown in FIG. [Figure 80] FIG. 80 illustrates a side view of the frame shown in FIG. 77 rotated from the position shown in FIG. [Figure 81] FIG. 81 illustrates a plan view of the frame shown in FIG. [Figure 82] FIG. 82 illustrates a side view of the inner frame shown in FIG. 77 separated from the outer frame shown in FIG. [Figure 83] FIG. 83 illustrates a side view of the outer frame shown in FIG. 77 separated from the inner frame shown in FIG. [Figure 84] FIG. 84 illustrates a side view of the frame shown in FIG. 77 in a crimped or compressed configuration. [Figure 85] FIG. 85 illustrates a side view of the frame shown in FIG. 77 in a crimped or compressed configuration and rotated from the position shown in FIG. [Figure 86] FIG. 86 illustrates a schematic top view of the frame shown in FIG. 77 in a crimped or compressed configuration. [Figure 87] FIG. 87 illustrates a perspective view of the frame. [Figure 88] FIG. 88 illustrates a perspective view of the frame. [Figure 89] FIG. 89 illustrates a detailed view of a portion of the frame shown in FIG. [Figure 90] FIG. 90 illustrates a schematic cross-sectional side view of a prosthetic valve. [Figure 91] FIG. 91 illustrates a side view of a strut cell of a prosthetic valve. [Figure 92] FIG. 92 illustrates a schematic side view of a portion of a prosthetic valve. [Figure 93] FIG. 93 illustrates a schematic cross-sectional side view of a prosthetic valve. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0036] 1 illustrates a perspective view of a prosthetic valve 10 in the form of a replacement heart valve. The prosthetic valve 10 may be configured to be deployed into a portion of a patient's body. The prosthetic valve 10 may be deployed within an annulus of a native valve, such as a native mitral valve or native tricuspid valve. In examples, other implantation locations may be used, such as within the aortic or pulmonary valve, or other valves or locations within the patient's body, as desired.

[0037] The prosthetic valve 10 may include a proximal end 12, a distal end 14 (shown in FIG. 3) and a length therebetween. The prosthetic valve 10 may further include one or more prosthetic leaflets 16, or a plurality of prosthetic leaflets 16, configured to surround a flow channel to control flow through the valve 10. The prosthetic leaflets 16 are configured to transition between an open state and a closed state to mimic and replace the behavior of the natural leaflets. In an example, the prosthetic leaflets 16 may be coupled to a frame or to an intermediate fabric portion connecting the prosthetic leaflets to the frame. The frame may include an inner frame 18, as shown in FIG. 2 and in cross section in FIG. 3, and may include an outer frame 20, as shown in FIGS. 1 and 3, where the outer frame 20 may be part of the seal body 11 and may be spaced radially outward from the inner frame 18.

[0038] 3 illustrates a schematic cross-sectional view of the prosthetic valve 10. The 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 may have a bulbous shape including a curved body that curves radially outward between the proximal end 19 and the distal end 21, or may have other configurations, as desired, in examples. The inner frame 18 may have a circular shape, as examples. The prosthetic valve leaflets 16 are disposed within the inner frame 18.

[0039] 2, the inner frame 18 may include a plurality of struts 23 with spaces 15 located between the struts 23. Such a configuration may allow the inner frame 18 to transition between a non-deployed or unexpanded or straight configuration and a deployed or expanded configuration. For example, the inner frame 18 may transition to the deployed or expanded configuration by expanding radially outward, where a diameter of the inner frame 18 increases such that a length of the inner frame 18 decreases. Other configurations for the inner frame 18 may be utilized as desired.

[0040] 1 and 3, the prosthetic valve 10 preferably includes one or more anchors 17 that may be coupled to the prosthetic leaflets 16. The anchors 17 are configured to anchor the prosthetic valve 10 to a portion of the patient's heart, such as to a native valve. The anchors 17 may be specifically configured to anchor to the native leaflets of the patient's heart. The anchors 17 may extend around the native leaflets to anchor to the native leaflets. The anchors 17 may include distal anchors disposed at the distal end 14 of the valve 10, or may be disposed at another location, such as, for example, a location along a mid-region of the valve 10.

[0041] Each anchor 17 may be configured as a protruding arm configured to extend distally and then bend proximally to the tip of the respective anchor 17. In this configuration, the anchor 17 may extend around and around the distal tip of the native leaflet to hook onto the distal tip of the native leaflet and may be positioned radially outward of the outward facing surface of the native leaflet. The anchor 17 may be configured to have a hook-like configuration, for example as shown in Figures 1-3. Thus, the anchor 17 may resist forces applied to the valve 10 in an atrial or proximal direction and may anchor the valve 10 in the native annulus. Other configurations for the anchor 17 may be utilized in examples as desired.

[0042] The anchor 17 is shown in FIGS. 1-3 in a deployed or expanded configuration with a tip of the anchor 17 extending proximally. In examples, the anchor 17 may be configured to be in a non-deployed or unextended or straight configuration with a tip of the anchor 17 extending distally. Such a configuration is shown, for example, in FIG. 5. The anchor 17 may be configured to be flexible in examples. Upon deployment, the anchor 17 may be configured to move radially outward from the non-deployed configuration to the deployed configuration with the tip flipping in the proximal direction. Such action may enable the anchor 17 to flip back onto the dorsal side of the native leaflet to capture the native leaflet upon deployment. Such a configuration is shown in FIG. 7 where the native leaflet 82 is disposed between the anchor 17 and the outer seal frame 11. Other deployment techniques for the anchor 17 may be utilized in examples as desired.

[0043] 3, the prosthetic leaflets 16 are supported within an inner frame 18. For example, a proximal portion of the inner frame 18 may be coupled to a proximal portion of the plurality of prosthetic leaflets 16. The prosthetic leaflets 16 may be coupled to the inner frame 18 and may extend radially inward from the inner frame 18. The prosthetic leaflets 16 may be coupled to the frame 18 via an intermediate body 28, which may support the prosthetic leaflets 16 and may couple the prosthetic leaflets 16 to the inner frame 18 via sutures or another technique as desired.

[0044] The prosthetic valve leaflets 16 may surround the flow channel 25 and transition between an open state and a closed state to control flow through the flow channel 25, as shown in FIG. 3. As shown in FIG. 3, the proximal end of the prosthetic valve 10 may include an inflow end of the prosthetic valve 10 and the distal end of the prosthetic valve 10 may include an outflow end, although other configurations may be utilized as desired. The prosthetic valve leaflets 16 may be disposed about a central axis 61 of the prosthetic valve 10. Each of the inner frame 18 and the outer frame 20 may surround the central axis 61 of the prosthetic valve 10.

[0045] Each of the anchors 17 may extend radially outward from the flow channel 25 and from the prosthetic cusps 16 of the valve 10. The anchors 17 may be coupled to a distal portion of the inner frame 18. Each of the anchors 17 may include a proximal portion 27 and a distal portion 29, where the proximal portion 27 is coupled to the inner frame 18 and the distal portion 29 includes a tip of the respective anchor 17. The anchors 17 may extend vertically from the proximal portion 27 to the tip of the distal portion 29 when the valve 10 is deployed.

[0046] 1, the prosthetic valve 10 preferably includes an outer seal body 11. The seal body 11 may be disposed radially outward from the prosthetic valve leaflets 16 and may be configured to seal against a portion of the native valve. The seal body 11 forms an outer surface of the valve 10. The seal body 11 may define an outer diameter of the valve 10 and may include an outer periphery of the valve 10. The seal body 11 includes a proximal portion having a proximal end 31 and a distal portion having a distal end 33 (shown in FIG. 3).

[0047] 3, the seal body 11 includes a frame 20 and a seal skirt 24, or in some examples may include only a frame or only a seal skirt, as desired. In the illustrated embodiment, the frame 20 includes an outer frame disposed radially outward from the inner frame 18. The seal skirt 24 is coupled to the outer frame 20 and forms an outer portion of the seal body 11, as shown in FIG.

[0048] At least a portion of the seal body 11 is configured to engage surrounding tissue to form a seal. The outer frame 20 is disposed radially outward of the inner frame 18. The outer frame 20 may have a proximal portion 35 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 leaflets 16. The distal portion 37 of the outer frame 20 may be spaced apart from the prosthetic leaflets 16 and from the inner frame 18 by a gap 39. The gap 39 may be disposed between the outer frame 20 of the seal body 11 and the distal portion of the inner frame 18. Thus, the inner frame 18 may include an inner frame, and the frame 20 of the seal body 11 may include an outer frame disposed radially outward of the inner frame 18 and surrounding the inner frame 18 and the prosthetic leaflets 16.

[0049] The outer frame 20 may have a length that extends distally a shorter distance compared to the distal end of the inner frame 18. As such, the outer frame 20 may be shorter than the inner frame 18 in the deployed state. The outer frame 20 may further have a curved configuration that curves outwardly from the inner frame 18, where the maximum diameter of the outer frame 20 is located along a distal portion of the outer frame 20.

[0050] The outer frame 20 of the seal body 11 includes a plurality of struts 49 (shown in FIG. 1) that form the frame 20 with spaces 51 between the struts. This configuration utilized with the frame 20 allows the frame 20 to transition between a non-deployed or unexpanded or straight configuration and a deployed or expanded configuration as shown in FIG. 1, in which the outer frame 20 and seal body 11 have a curved bulbous shape. As with the valve frame 18, the length of the outer frame 20 of the seal body 11 may decrease as the diameter of the outer frame 20 of the seal body 11 increases upon deployment. The diameter of the outer frame 20 of the seal body 11 may expand radially outward simultaneously with the inner valve frame 18, or may expand radially outward at a different time or rate than the inner valve frame 18, in examples.

[0051] The seal body 11 may include a seal skirt 24 (as shown in FIG. 1 ) that may extend around the inner valve frame 18 and around the prosthetic valve leaflets 16. The skirt 24 may be directly bonded to the seal body frame 20 or may be free to extend outwardly from the frame 20.

[0052] Seal skirt 24 has a proximal portion 41 (shown in FIG. 3) that is coupled to a proximal portion of seal body 11 and may also be coupled to a proximal portion of inner frame 18. Skirt 24 may have a distal portion 43 (shown in FIG. 3) that may be coupled to a distal end of frame 20, in example to inner valve frame 18 or to one or more anchors 17. As shown in FIG. 3, anchors 17 are configured to extend radially outward from inner valve frame 18 and across gap 39 to a tip of each corresponding anchor 17.

[0053] The seal skirt 24 is preferably formed from a material that resists fluid flow therethrough, such as a cloth material, a woven material, or a polymer. The material may include cloth. Various materials for the skirt 24 may be utilized as desired.

[0054] The seal body 11 may be configured to abut against a portion of the patient's heart to reduce fluid communication. The skirt 24 may be configured to seal against a portion of the native valve annulus. For example, the seal body 11 may abut against the surface of the patient's native valve leaflets to reduce fluid communication between the seal body 11 and the native valve leaflets. The seal body 11 may be configured to abut against other portions of the patient's heart to reduce fluid communication, as desired.

[0055] In an example, seal body 11 may be flexible to allow movement and conformance with the native valve annulus.

[0056] In examples, one or more magnets may be utilized to draw portions of the prosthetic valve 10 toward one another. For example, one or more magnets may be configured to draw the anchor 17 toward the seal body 11. Magnets may also be provided in other locations to draw other portions of the prosthetic valve together as desired.

[0057] 1 , the magnet(s) may be disposed at various locations on the prosthetic valve 10. In one example, the magnet(s) is embedded within or attached to the anchor 17. A magnet 62 may be disposed on each anchor 17, preferably on the tip of the anchor 17. In an example, each magnet 62 may be disposed on the anchor 17 such that the magnets 62 are circumferentially spaced apart from one another and such that the magnets 62 are radially spaced apart from the seal body 11.

[0058] In an example, one or more magnets 64 may be disposed on the seal body 11. The magnets 64 may be disposed on the seal body 11 and circumferentially spaced apart from one another. The magnets 64 may be disposed in circumferential alignment with the magnets 62 on the anchor 17, in an example, or may be disposed at another location. For example, the magnets 64 may be adjacent to the magnets 62 on another side of the native leaflet. The magnets 64 may be disposed proximate to the magnets 62 on the anchor 17. The magnets 64 may be coupled to the outer frame 20, or may be embedded within the seal skirt 24, or may otherwise be coupled to the seal body 11. The outer frame 20 may include a proximal portion 63 that may be coupled to the inner frame 18, and a distal portion 65. The magnets 64 may be disposed on the distal portion 65, in an example, or may be disposed at another location.

[0059] In the example, magnet 62 on anchor 17 is configured to interact with an opposing magnet 64 disposed on seal body 11. The polarities of magnets 62, 64 may be set, for example, such that a magnetic attraction is generated between magnets 62, 64, drawing magnets 62, 64 toward one another. In a corresponding manner, respective anchors 17 and seal bodies 11 may be attracted toward one another.

[0060] In examples, a magnetically responsive material, such as a ferromagnetic material, may be utilized in combination with or in place of the magnet. For example, a ferromagnetic material, such as iron, or another metal or alloy, may be utilized to attract one of the magnets 62, 64. For example, a ferromagnetic material may be used in place of the magnet 62 on the anchor 17 and may be attracted to the magnet 64 on the seal body 11. Similarly, a ferromagnetic material may be used in place of the magnet 64 on the seal body 11 and may be attracted to the magnet 62 on the anchor 17. In examples, a combination of magnets and ferromagnetic materials may be utilized, as desired.

[0061] Figure 4 illustrates the advancement of a delivery system 70 for deploying the prosthetic valve 10 to an implantation site. The delivery system 70 may include an elongate shaft 72 having a proximal portion and a distal portion, where the proximal portion is coupled to a housing in the form of a handle 74. The delivery system 70 may be driven forward through the patient's vascular system, such as through the femoral vein as shown in Figure 4. Other introduction techniques may be utilized, including transapical, for example, and via a surgical technique such as open chest or open heart surgery.

[0062] The prosthetic valve 10 may be placed within an implant-retaining region of the delivery system 70 and may be encapsulated or otherwise retained prior to deployment. The prosthetic valve 10 may be deployed as a self-expanding prosthetic valve, a balloon-expandable prosthetic valve (e.g., placed on an inflatable balloon upon introduction into the patient's body or slid onto an inflatable balloon within the patient's body), mechanically expanded, or in other deployed configurations.

[0063] Delivery system 70 may be driven forward and passed into an atrium of the heart and may be passed transseptally into another atrium (e.g., from the right atrium to the left atrium) to reach the implantation site. Such a delivery approach may be utilized, for example, for access to the mitral native valve. In an example, delivery system 70 may extend into the right atrium, for example, for tricuspid valve access, or other delivery approaches to other implantation sites may be utilized, as desired, for example.

[0064] 5 illustrates a side cross-sectional view of the prosthetic valve 10 in a compressed configuration within the capsule 79 of the delivery system 70. The anchors 17 are shown in an elongated configuration and extending longitudinally. The prosthetic valve 10 may be positioned to be deployed relative to the native valve 80.

[0065] 6 illustrates the prosthetic valve 10 partially deployed relative to the native valve 80. The anchors 17 may be driven forward and deployed radially outward from the capsule 79. The anchors 17 may be hooked onto the native leaflets 82 such that the tips of the anchors 17 are located radially outward of the native leaflets 82. Thus, the magnets 62 coupled to the anchors 17 may be located radially outward of the native leaflets 82.

[0066] 7 illustrates the prosthetic valve 10 deployed relative to a native valve 80. A magnet 62 coupled to the anchor 17 is disposed radially outward of the native leaflets 82. A magnet 64 coupled to the seal body 11 is disposed radially inward of the native leaflets 82. The magnets 62, 64 may be circumferentially aligned with one another and axially aligned with one another to create a magnetic attraction between the magnets 62, 64.

[0067] 8 provides a close-up view of the magnets 62, 64 interacting with one another. The magnets 62, 64 may be positioned on opposite sides of the native leaflets 82 to create a magnetic attraction force (represented by lines 84) through the native leaflets 82.

[0068] The magnets 62, 64 may be configured to enhance clamping of the native leaflets 82 between the seal body 11 and the anchor 17. The additional clamping force applied by the magnets 62, 64 may provide various benefits, including improved anchoring of the prosthetic valve 10 to the native valve and enhanced sealing against fluid communication (e.g., paravalvular leakage) around the prosthetic valve 10. The compression applied by the magnets 62, 64 against the native leaflets 82 may enhance the seal provided by the seal body 11 by pressing the seal body 11 against the native leaflets 82. In an example, one or more of the magnets 62, 64 may be supplemented or replaced by a magnetically responsive material, such as a ferromagnetic material, as desired.

[0069] Each feature in the examples of Figures 1-8 may be used alone or in combination with any other feature disclosed herein.

[0070] 9 illustrates another example of an anchor 90 that may be utilized in the examples herein. The anchor 90 may be configured to anchor the prosthetic valve and prosthetic valve leaflets to the native valve in a manner similar to that of the anchor 17 shown in FIGS. 1-3.

[0071] The anchor 90 may include an elongate 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 elongate arm has a length. The first portion 92 may be coupled to a valve body 91, and the elongate arm may extend radially outward from the valve body 91 to the tip 96. The valve body 91 may support one or more prosthetic valve leaflets, for example, in a manner similar to the valve body shown in Figures 1-3.

[0072] Anchor 90 may be hook-like in configuration and may include curved portion 98 having a convex curvature, where surface 100 faces radially inward and surface 102 faces radially outward. Anchor 90 may be configured to hook onto the distal tips of the native valve leaflets in a manner similar to anchor 17 shown in Figures 1-3.

[0073] The anchor 90 preferably includes one or more grooves 104 configured to increase flexibility (i.e., reduce bending stiffness) of the anchor 90. The one or more grooves 104 may extend transversely to the length of the anchor 90. In examples, multiple grooves 104 may be provided such that they may be spaced apart from one another along the length of the anchor 90. As shown in FIG. 9, the one or more grooves 104 may be disposed on the curved portion 98 and may be disposed on the radially inward facing surface 100.

[0074] The one or more grooves 104 are configured to increase the flexibility of the anchor 90 in a radially inward direction. Using this configuration, the anchor 90 may be configured to flex radially inwardly upon implantation, as represented by the arrows in FIG. 9. Such flexibility may provide various advantages, including reduced electrical conduction interference with the native valve annulus and reduced potential damage to the native valve. As a result, improved deployment, attachment, and fit within the native valve may be achieved.

[0075] 10 illustrates an example of an anchor 106 with grooves formed on both sides. 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 may be similarly configured as compared to the grooves 108 on the inwardly facing surface 110, which may be similar to grooves 104. As a result, increased flexibility may be achieved in the radially inward and radially outward directions.

[0076] Thus, the anchors may be unidirectional or bidirectional, or may have flexibility in other directions, for example. Increasing the flexibility of the anchors may improve the likelihood of structural deformation of the ventricle and may reduce the likelihood of conduction disturbances within the ventricle. The anchors may flex with structural deformation of the ventricle.

[0077] Each feature in the examples of Figures 9 and 10 may be used alone or in combination with any other feature disclosed herein.

[0078] 11-13 illustrate another example of an anchor 120 that may be utilized in the examples herein. Anchor 120 is adapted to help secure a prosthetic valve within a native valve in a manner similar to anchor 17 shown in FIGS. 1-3.

[0079] The anchor 120 may include an elongate arm that may include a first or inner or mating portion and may extend radially outward to a second or outer portion 124 including a distal portion 126. The elongate arm may have a length. The first portion 122 may be for mating to a valve body 128, and the elongate arm may extend radially outward from the valve body 128 to the distal portion 126. The valve body 128 may support one or more prosthetic leaflets, for example, in a manner similar to the valve body shown in FIGS. 1-3.

[0080] Anchor 120 may be hook-like in configuration and may include a curved portion 130 having a convex curvature, where curved portion 130 has a radially inwardly facing surface 132 and a radially outwardly facing surface 134. Anchor 120 may be configured to hook onto the distal tips of the native leaflets in a manner similar to anchor 17 shown in Figures 1-3. Radially inwardly facing surface 132 may include an inner diameter of anchor 120 and radially outwardly facing surface 134 may include an outer diameter of anchor 120.

[0081] Figure 12 illustrates a cross-sectional view of the anchor 120 shown in Figure 11. The illustrated anchor 120 includes a coil 136. The coil 136 may include a first or inner or coupling portion 138 and may extend radially outward to a second portion 140. The coil 136 may form an elongate arm and may extend radially outward from the coupling portion of the anchor 120 to the distal portion 126 of the anchor. The coil may be integral to the coupling portion or may be a separate member attached to the coupling portion.

[0082] The coil 136 may include a spring coil and may include wire bent into a helical shape. In an example, the coil 136 may include a hypotube cut into a coil shape, or may have another configuration as desired.

[0083] The coil 136 may have a first coil portion 142 that may have a greater stiffness compared to the second coil portion 144. The first coil portion 142 may have, for example, denser coil turns compared to the second coil portion 144, in which case the second coil portion 144 has greater flexibility compared to the first coil portion 142. The second coil portion 144 may include a gap that allows for localized compression and complete bending of the coil at the second coil portion 144. The second coil portion 144 may be positioned in various locations, including being positioned radially outward of the first coil portion 142 as shown in FIG. 12. In an example, the second coil portion 144 may be positioned radially inward of the first coil portion 142 having a greater stiffness. In an example, portions of the coil 136 may have greater or lesser stiffness and may be variably positioned as desired. For example, the portions having a lesser stiffness may be interwoven with the portions having a greater stiffness as desired.

[0084] In examples, second coil portion 144, having a lesser stiffness, may be disposed along curved portion 130 of anchor 120 to increase the flexibility of anchor 120 at apexes or at angled portions of anchor 120. Thus, anchor 120 may be more easily deflectable at second coil portion 144 compared to first coil portion 142.

[0085] In an example, third coil portion 146 may be disposed radially outward of second coil portion 144. Third coil portion 146 may have a greater stiffness as compared to second coil portion 144 and may extend radially outward to distal portion 126 of anchor 120. In an example, second coil portion 144 may be disposed between first coil portion 142 and third coil portion 146 to provide greater flexibility at the apex or slope portion of anchor 120 between the stiffer first coil portion 142 and third coil portion 146. Thus, anchor 120 may have greater flexibility at second coil portion 144.

[0086] In various examples, the anchor 120 may further include a stiffening arm 148. The stiffening arm 148 may include an elongate arm extending along the coil 136 and may increase the stiffness of the anchor 120. The stiffening arm 148 may include a first portion 150, or inner portion, and may extend radially outward to a second portion 152, or outer portion. The length of the stiffening arm 148 may extend along the length of the coil 136 from the first portion 138 of the coil 136 to the second portion 140 of the coil 136, and may extend along the length of the anchor 120 from the first portion 122 of the anchor 120 to the second portion 124 of the anchor 120.

[0087] The stiffening arms 148 may extend parallel to the length of the coil 136 and may extend along the outer diameter of the anchor 120. The stiffening arms 148 may be disposed on the outside of the coil 136. The stiffening arms 148 may be disposed circumferentially relative to the coil 136, along the outside of the outer diameter of the coil 136, on one side of the coil 136. FIG. 13 illustrates a cross-sectional view of the anchor 120 taken along line AA in FIG. 12, for example. FIG. 13 illustrates the stiffening arms 148 along the outer diameter of the coil 136 on one side of the coil 136. One or more stiffening arms may be provided in other locations as desired. For example, the stiffening arms may be disposed along the inner diameter of the anchor 120, or may be disposed along the neutral axis of the coil 136, in the example. Multiple stiffening arms may be utilized in various locations as desired.

[0088] The stiffening arms 148 may strengthen the anchor 120 and may support the anchor 120 against circumferential loads (e.g., inward and outward forces as shown in FIG. 12 ). The stiffening arms 148 may further reduce the likelihood of the anchor 120 adversely deflecting radially outward from the valve body. In examples, the stiffening arms may be omitted, if desired.

[0089] In an example, the anchor 120 may include a cover 154 that may be disposed over the coil 136 and over the stiffening arms 148. The cover 154 may protect the interior of the anchor 120, including the coil 136 and the stiffening arms 148. The cover 154 may further bond the interior of the anchor 120, including the coil 136 and the stiffening arms 148 together. The cover 154 may include a sheath that may extend over the coil 136 and over the stiffening arms 148. The cover 154 may extend along the entire length of the coil 136 and the stiffening arms 148. The cover 154 may be atraumatic to reduce the possibility of damaging the native valve.

[0090] In an example, the cover 154 may include an overmold that may be disposed over the coil 136 and over the stiffening arms 148. The overmold may be flexible to allow the anchor 120 to flex while still sealingly coupling the coil 136 and the stiffening arms 148. Figure 13, for example, illustrates the cover 154 in the form of an overmold that encapsulates the coil 136 and the stiffening arms 148. Various forms of overmolds may be provided, including a polymeric overmold or another form of overmold.

[0091] Coil 136 may be configured to increase the flexibility of anchor 120 in a radially inward direction. The flexibility of anchor 120 may allow anchor 120 to flex and conform to the shape of the native valve and may reduce the possibility of electrical conduction interference and damage to the native valve. As a result, improved deployment, attachment, and conformance within the native valve may be obtained. In an example, enhanced flexibility may be provided in a radially outward direction.

[0092] Each feature in the examples of Figures 9-13 may be used alone or in combination with any other example disclosed herein.

[0093] 14 illustrates another example of a prosthetic valve 160. In this embodiment, the prosthetic valve 160 includes a valve body 162 surrounding an interior flow channel 164. One or more anchors 166 are pivotally coupled to the valve body 162 and 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.

[0094] As with the previous embodiments, the valve body 162 supports one or more prosthetic leaflets (e.g., as shown in FIG. 2) disposed within the flow channel 164. The valve body 162 may include a frame and may include a seal body, which may be similar to other examples disclosed herein. The outer surface 168 of the valve body 162 may include a portion of the valve body 162 configured to contact against a portion of the native valve, which may include, for example, a native leaflet or another portion of the valve body 162. For example, the outer surface 168 of the valve body 162 may include a seal skirt, which may be configured to seal against a portion of the native valve. In examples, various other configurations for the valve body may be utilized.

[0095] The longitudinal dimension of the flow channel 164 defines a direction of fluid flow through the prosthetic valve 160. A central axis 170 (shown in FIGS. 14 and 15 ) may extend along the longitudinal dimension. The valve body 162 may be centered on the central axis 170.

[0096] The anchors 166 may include distal anchors as shown in FIG. 14. For example, each of the distal anchors may have a hook-like configuration. The distal anchors may have curved portions 172 that may be configured to hook onto the distal tips of the native leaflets, for example, to anchor the prosthetic valve 160 to the implantation site. In examples, various other configurations for the anchors 166 may be utilized.

[0097] The anchors 166 may include an inner or coupling portion 174 that may pivotally couple the anchors 166 to the valve body 162. A coupler in the form of a hinge 176 or other configuration may couple the coupling portion 174 to the valve body 162. The hinge 176 may allow the anchors to rotate relative to the hinge (or similar mechanism) while fixing the anchors to the valve body. Each anchor 166 may be configured to pivot about a respective axis 178 (shown in FIG. 15 ), which may extend parallel to the central axis 170, for example. Each anchor 166 may be circumferentially spaced apart from one another, and the spacing may be equal or, in some examples, may vary.

[0098] Each of the anchors 166 may include a tip 182 configured to rotate about the hinge 176 .

[0099] Pivoting the anchor 166 may change the maximum diametric distance of the anchor 166 from the valve body 162. For example, with reference to FIGURE 15, the anchor 166 is shown in plan view and extends perpendicular to the outer surface 168 of the valve body 162. When configured in this manner, the anchor 166 may have a maximum radial extent relative to the outer surface 168 of the valve body 162.

[0100] 16, the anchors 166 may be pivoted about the longitudinal dimension to change the radial distance 180 of the anchors 166 from the valve body 162. Each anchor 166 is rotated counterclockwise, as shown in FIG. 16, to pull the tip 182 of the anchor 166 toward the outer surface 168 of the valve body 162. The maximum radial extent of the anchors 166 is reduced from the position shown in FIG. 15. The maximum radial extent of the prosthetic valve 160 has been changed. The anchors 166 may be pivoted further, as desired. The length 183 of each anchor 166 may remain constant as the anchors 166 are pivoted about the longitudinal dimension.

[0101] 17 illustrates the anchor 166 being continuously rotationally driven, for example, in a counterclockwise direction. The tip 182 may be drawn toward the outer surface 168 of the valve body 162, decreasing the maximum radial extent of the anchor 166. At least a portion of the anchor 166 may extend parallel to the outer surface 168 of the valve body 162.

[0102] The anchor 166 may be pivoted to accommodate the size of the native valve. Thus, if the native valve has a relatively small size, the anchor 166 may have a reduced maximum radial extent, and if the native valve has a larger size, the anchor 166 may have an increased maximum radial extent. Thus, the angle at which the anchor 166 is disposed relative to the outer surface 168 of the valve body 162 may be altered to accommodate the size of the native valve. FIG. 17 illustrates, for example, a representative location of the native leaflet 82 by dashed lines. The tip 182 of the anchor 166 may be disposed radially outward of the native leaflet 82. If the native leaflet 82 is thicker or is disposed further from the outer surface 168 of the valve body 162, the anchor 166 may be rotationally driven farther from the outer surface 168 of the valve body 162 and may have a longer radial extent compared to that shown in FIG. 17.

[0103] The anchors 166 may, for example, be configured to press the native valve leaflets against an outer surface 168 of the valve body 162. The outer surface 168 may include a sealing body, such as a sealing skirt, or other form of sealing body, as desired. Thus, the anchors 166 may improve the fluid seal between the valve body 162 and the native valve and, for example, may reduce leakage, such as paravalvular leakage.

[0104] In examples, a varying number of anchors 166 may be utilized. Figure 18 illustrates an example of a prosthetic valve 184 that includes a greater number of anchors 186 than those shown in the examples of Figures 14-17, for example. The anchors 186 may be circumferentially spaced apart from one another, and the circumferential spacing may be equal or, in examples, may vary.

[0105] The anchors 166, 186 may be deflected to a radial position prior to insertion into the patient's body and prior to deployment. For example, the native valve may be sized prior to insertion of the prosthetic valve 160, 184, and the anchors 166, 186 may then be set to a prescribed angle prior to insertion. With the anchors 166, 186 set in a radial position, the prosthetic valve 160, 184 may be compressed relative to the delivery device and then deployed relative to the native valve in a manner that may include the deployment techniques disclosed herein.

[0106] In an example, the anchors 166, 186 may be pivotable in vivo. During deployment, the anchors 166, 186 and / or the valve body 162 may be rotationally driven to a maximum radial distance of the anchors 166, 186 from the valve body 162. The anchors 166, 186 may be deployed, for example, from a delivery device or may be pivoted to change their radial distance from the valve body 162 after latching around the native valve leaflets. Changing the maximum radial distance may be performed in vivo and in conjunction with imaging of the implantation site.

[0107] In examples, the valve body 162 may be rotationally driven by the delivery device relative to the native valve to vary the maximum radial distance of the anchors 166, 186 from the valve body 162.

[0108] In an example, the anchors 166, 186 may be freely pivotable relative to the valve body 162. Thus, upon deployment, the anchors 166, 186 may be freely pivotable about the valve body 162 to conform to the size of the native valve. The anchors 166, 186 may be pivotable to allow the anchoring sites to be stretched or contracted as desired. Using this feature, the diameter of the native valve upon deployment may be actively altered.

[0109] In examples, one or more locking members may be provided that may lock the anchors 166, 186 in position relative to the valve body 162. The locking members may lock the anchors 166, 186 against movement about the longitudinal dimension. The locking members may be set prior to insertion of the prosthetic valve 160, 184 into the patient's body. In examples, the locking members may be actuated in vivo.

[0110] 19 illustrates a cross-sectional view of a hinge 176 that may include, for example, a locking member 188. The locking member 188 may include a spacer 190 and a protrusion 192, or may have another configuration for locking, as desired. The locking member 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. Once the anchor 166 has pivoted to a desired position, the spacer 190 may be withdrawn from the hinge 176, allowing the protrusion 192 to contact the coupling portion 174 of the anchor 166, thereby locking 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.

[0111] 20 illustrates how anchor 166 may be locked in place, for example, by withdrawing spacer 190 from hinge 176. Locking member 188 may be locked in vivo once anchor 166 is positioned at a desired angle relative to valve body 162. Various other configurations for the locking member may be utilized in examples, as desired.

[0112] The anchors 166, 186 may have a variety of shapes and configurations. FIG. 21, for example, illustrates an anchor 194 having a distal curved portion 196 that may be configured to hook onto the distal tip of a prosthetic valve leaflet, similar to the curved portion 172 shown in FIG. 14. The anchors 194 may include distal or ventricular anchors. Each of the anchors 194 may include a proximal frame support 198 that may be configured to support a seal body or may be utilized as a proximal or atrial anchor, as desired. The proximal frame support 198 may include, for example, an elongated arm that may extend radially outward from the valve body 200. The proximal frame support 198 may have a hook-like configuration and may be configured to hook onto the proximal or atrial side of the native valve to anchor the prosthetic valve 202 in place. In examples, the proximal frame supports 198 may have other configurations as desired. The proximal frame supports 198 may be coupled to respective distal anchors and configured to pivot about the longitudinal dimension with the distal anchors. In examples, the proximal frame supports 198 may be integral to the distal curved portion 196. Various other configurations for the anchors 194 may be utilized as desired.

[0113] In an example, the anchors 166, 186, 194 may be configured to have adjustable axial positions. For example, the axial positions of the anchors 166, 186, 194 along each axis about which the anchors may pivot (e.g., axis 178 as shown in FIG. 15) may be adjusted. The adjustment may be made along the dimension of the flow channel of the prosthetic valve (e.g., parallel to the central axis 170 shown in FIG. 15). The adjustment may be made proximally or distally (or a combination of proximal and distal) as desired. The adjustment may be made prior to implantation or in vivo. In vivo adjustment may allow the axial positions of the anchors 166, 186, 194 to be adjusted to correspond to the size of the native anatomy (e.g., the size or length of the native leaflets). In vivo adjustment may be used to allow the anchors to capture or recapture leaflets that they have missed. For example, an anchor that fails to capture a leaflet may be driven distally forward to allow the anchor to extend over the native leaflet and then retract proximally, thereby capturing the leaflet. In an example, a combination of axial position adjustment and varying the radial distance of the anchors 166, 186, 194 from the valve body may be utilized.

[0114] Each feature in the examples of Figures 14-21 may be used alone or in combination with any other example disclosed herein.

[0115] 22 illustrates another example of a prosthetic valve 210. In this embodiment, the prosthetic valve 210 includes a band 212 having an adjustable diameter, which allows a seal body 214 to be adjusted radially inward or outward. The prosthetic valve 210 may include one or more prosthetic leaflets (e.g., as shown in FIG. 2) disposed within a flow channel 218 to provide a one-way valve. The valve body 216 may include a frame that may surround the flow channel 218 and support the prosthetic leaflets within the flow channel 218. The frame may include an inner frame that may be disposed radially inward of the seal body 214. The valve body 216 may have a cylindrical shape or may have other shapes as desired.

[0116] The prosthetic valve 210 may include one or more anchors 220 that may be configured to anchor one or more prosthetic leaflets to the native valve. The anchors 220 may include a distal anchor, which may be configured, for example, similar to anchor 17 shown in FIG. 1. The anchors 220 may have, for example, a hook-like configuration. The distal anchors may be configured, for example, to hook onto the distal tips of the native leaflets to anchor the prosthetic valve 210 to the implantation site. In examples, various other configurations for the anchors 220 may be utilized.

[0117] The seal body 214 may be disposed radially outward of one or more prosthetic leaflets and may be configured to seal against a portion of the native valve. The seal body 214 may include a proximal portion 222 that may be coupled to a proximal portion of the valve body 216 and may include a distal portion 224 that may be coupled to a distal portion of the valve body 216 or to one or more anchors 220. The seal body 214 includes an outer surface 226 configured to contact and seal against surrounding tissue of the native valve. The seal body 214 may include an inner surface 228 that may face opposite the outer surface 226.

[0118] The seal body 214, in examples, may be flexible and may be configured to be resilient, and thus may be configured to move or stretch radially outward from the valve body 216, if desired. The seal body 214 may include a seal skirt.

[0119] The band 212 extends around the valve body 216 and around the artificial leaflets. The band 212 may be disposed radially outward of the valve body 216 and the artificial leaflets. The band 212 may extend circumferentially around the seal body 214. For example, the band 212 may be disposed radially inward of the seal body 214, or radially outward of the seal body 214, or may be disposed internally of the seal body 214, in examples. The band 212 may form a loop, in examples. The loop may be configured to apply a force to the seal body 214 to move the seal body 214 radially outward or radially inward.

[0120] FIG. 24 illustrates a cross-sectional view from above of the prosthetic valve 210 shown in FIG. 22. 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 or free from one another, in examples. For example, as shown in FIG. 24, the first end portion 230 may include a coupler 234 through which the second end portion 232 may slide. The coupler 234 may be disposed at an end of the first end portion 230, and the second end portion 232 may be configured to slide through the coupler 234 to adjust the diameter 236 of the band 212. The first end portion 230 may extend along a length of the second end portion 232. The band 212 may include a loop having an end at the second end portion 232, where the first end portion 230 is configured to overlap the end at the second end portion 232. The band 212 may have a circular shape. In examples, other configurations may be utilized.

[0121] Changing the amount of overlap of first end portion 230 relative to second end portion 232 may change diameter 236 of band 212. For example, decreasing the amount of overlap may increase diameter 236 of band 212 and increasing the amount of overlap may decrease diameter 236. When diameter 236 of band 212 increases, band 212 may drive seal body 214 radially outward. When diameter 236 of band 212 decreases, band 212 may drive seal body 214 radially inward.

[0122] Second end portion 232 of band 212 may be configured to be located radially outward of first end portion 230, as shown in Figure 24. In an example, second end portion 238 may be disposed radially inward of first end portion 240 of band 242, as shown, for example, in Figure 25.

[0123] The diameter 236 of the band 212 may be adjusted in a variety of ways. For example, a portion of the band 212 may be accessible through the seal body 214 and manipulated to change the diameter 236 of the band 212. With reference to FIG. 24, for example, the second end portion 232 may be grasped and slid relative to the first end portion 230, thereby changing the diameter 236 of the band 212. The second end portion 232 may be grasped by a device such as tweezers or may be grasped by a portion of a delivery system, as desired. The coupler 234 may include a ratcheting or other form of locking member to maintain the diameter 236 of the band 212, as desired.

[0124] In an example, an adjustment mechanism may be provided that may be configured to adjust the diameter of the band. For example, referring to FIG. 26, the adjustment mechanism 244 may include a gear 246 that may be configured to be driven in rotation to adjust the amount of overlap of the first end portion 240 relative to the second end portion 238. The gear 246 may include teeth that may engage with recesses on the second end portion 238, for example, that may be configured to be driven in rotation to drive the second end portion 238 relative to the first end portion 240. An adjustment device including a mating gear 248 may be used to mesh the gear 246. The mating gear 248 may be power driven or otherwise rotatable (e.g., via a tension tether or via another control member) to rotate the mating gear 248. The mating gear 248 may contact the gear 246 and may be driven in rotation in a direction to increase or decrease the diameter of the band. The adjustment mechanism may be located at the end of the band and may be configured to adjust the diameter of the band. Other forms of adjustment mechanisms may be utilized as desired.

[0125] By utilizing the band, the outward bulge of the seal body 214 may be altered, allowing the seal body 214 to be pressed and conform to the shape of the native valve. Thus, the prosthetic valve 210 may be deployed and the band 212 adjusted in vivo to bring the seal body 214 into contact with the native valve, causing the seal body 214 to apply a force against the native valve. The contact between the seal body 214 and the native valve may reduce fluid communication or leakage around the prosthetic valve 210. The band may be adjusted in vivo to account for the altered size and shape of the native valve.

[0126] In examples, the diameter of the band may be adjusted prior to insertion into the patient's body, e.g., the size of the native valve may be imaged and the band may be adjusted to fit the size of the native valve.

[0127] Each feature in the examples of Figures 22-26 may be used alone or in combination with any other examples disclosed herein.

[0128] Figure 27 illustrates another example of a prosthetic valve 260 that includes a valve frame 262 that surrounds a flow channel 264. A seal skirt 266 is disposed radially outward from the valve frame 262, and is held in tension and configured to flex to conform to the shape of the native valve. Figure 28 illustrates a space (e.g., clearance) 268 between the seal skirt 266 and the valve frame 262.

[0129] 27, the valve frame 262 may support one or more prosthetic leaflets (e.g., as shown in FIG. 2) coupled thereto, which may extend radially inward from the valve frame 262 and may be disposed within the flow channel 264. The valve frame 262 may support the prosthetic leaflets within the flow channel 264. The valve frame 262 may be disposed radially inward of a seal skirt 266. The valve frame 262 may have a cylindrical shape or may have other shapes, as desired.

[0130] The valve frame 262 may be configured to compress and expand in a manner similar to the inner frame 18 described with respect to Figures 1-3. The valve frame 262 may, for example, expand radially outward and the length of the valve frame 262 may decrease (e.g., as shown in Figure 28). The valve frame 262 may be in a compressed or undeployed configuration in Figure 27 and in an uncompressed or deployed configuration in Figure 28. In this manner, the diameter of the valve frame 262 may expand radially outward and the length of the valve frame 262 may decrease, as shown in Figure 28.

[0131] The seal skirt 266 may be disposed radially outward of one or more prosthetic valve leaflets and of the valve frame 262 and may be configured to seal against a portion of the native valve. The seal skirt 266 may surround the valve frame 262. The seal skirt 266 may include a proximal portion 270 and a distal portion 272. The seal skirt 266 may be suspended between the proximal portion 270 and the distal portion 272 and may be retained with a space 268 between the seal skirt 266 and the valve frame 262.

[0132] The prosthetic valve 260 may include one or more proximal tensioning bodies 274 and one or more distal tensioning bodies 276. The proximal tensioning bodies 274 may be disposed at a proximal portion of the prosthetic valve 260 and the distal tensioning bodies 276 may be disposed at a distal portion of the prosthetic valve 260. A proximal portion 270 of the seal skirt 266, including a proximal end of the seal skirt 266, may be coupled to the proximal tensioning body 274. A distal portion 272 of the seal skirt 266, including a distal end of the seal skirt 266, may be coupled to the distal tensioning body 276.

[0133] The proximal tensioning body 274 may have a variety of configurations. As shown in FIGS. 27-29 , the proximal tensioning body 274 may 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 may extend radially outward from the proximal portion of the valve frame 262. Similarly, the distal tensioning body 276 may 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 may extend radially outward from the distal portion of the valve frame 262. 29, the arms of the proximal tensioning body 274 and the arms of the distal tensioning body may be circumferentially spaced apart from one another and may extend radially outward from the flow channel 264. The spacing may be equal to one another in the circumferential direction, or a varying spacing may be provided.

[0134] The seal skirt 266 may be tensioned by a proximal tensioning body 274 and a distal tensioning body 276. For example, with reference to Figures 28 and 29, when the valve frame 262 is expanded, the seal skirt 266 may be tensioned and held in suspension between the proximal tensioning body 274 and the distal tensioning body 276. A central portion of the seal skirt 266 may be free from the frame and may be flexible inwardly to conform to the shape of the native valve. The seal skirt 266 may be resilient and configured to flexible inwardly to conform to the shape of the native valve, for example.

[0135] 30, for example, illustrates the prosthetic valve 260 deployed relative to the native valve 80. The tensioned sealing skirt 266 flexes radially inward to conform to the shape of the native valve 80, particularly the location of the native valve leaflets 82. The sealing skirt 266 may form a seal against the native valve 80 to reduce fluid communication (e.g., paravalvular leakage) outside the flow channel 264.

[0136] 30 , in examples, distal tensioning body 276 may include a distal or ventricular anchor for prosthetic valve 260. Proximal tensioning body 274 may include a proximal or atrial anchor for prosthetic valve 260. Thus, distal tensioning body 276 and proximal tensioning body 274 may anchor prosthetic valve 260 in place and may resist proximal and distal movement, i.e., atrium and ventricle movement.

[0137] The proximal or distal tensioning bodies may have other configurations, in examples. For example, with reference to FIG. 31 , the proximal tensioning body may include a ring 290. The ring 290 may be compressible and may be biased to expand outwardly or into the shape shown in FIG. 31 . The ring 290 may support a proximal end portion 292 of a seal skirt 294. The distal tensioning body may include a ring 296. The ring 296 may likewise be compressible and may be biased to expand outwardly or into the shape shown in FIG. 31 .

[0138] The seal skirt 294 may be tensioned by a proximal ring 290 and a distal ring 296. For example, as shown in cross section in FIG 32, the seal skirt 294 may be in tension and disposed with a space 298 between the seal skirt 294 and the valve frame 300. The seal skirt 294 may be configured to flex inwardly in a manner similar to the seal skirt 266 shown in FIG 30.

[0139] FIG. 33 illustrates a prosthetic valve 301 in which a seal skirt 302 is supported by a number of wires 304. The wires 304 may extend along the seal skirt 302. The seal skirt 302 may be disposed radially outward from a valve frame 306 with a space between the seal skirt 302 and the valve frame 306, and the seal skirt 302 is in tension and configured to flex to conform to the shape of the native valve. The wires 304 may extend axially and may be spaced apart from one another circumferentially around the valve frame 306. The wires 304 may be configured to flex inward with the seal skirt 302.

[0140] FIG. 34 illustrates an example of a prosthetic valve 310 in which a seal skirt 312 is supported by a number of wires 314. The wires 314 may extend along the seal skirt 312. The seal skirt 312 may be disposed radially outward from a valve frame 316 with a space between the seal skirt 312 and the valve frame 316, and the seal skirt 312 is in tension and configured to flex to conform to the shape of the native valve. Each of the wires 314 may extend circumferentially and may be spaced apart from one another in the axial direction. The wires 314 may be configured to flex inward with the seal skirt 312.

[0141] FIG. 35 illustrates an example of an artificial valve 320, in which a seal skirt 322 is supported by a number of wires 324. The wires 324 may extend along the seal skirt 322. The seal skirt 322 may be disposed radially outward from a valve frame 326 with a space between the seal skirt 322 and the valve frame 326, and the seal skirt 322 is in tension and configured to flex to conform to the shape of the native valve. Each of the wires 324 may extend axially at an angle to a central axis of the artificial valve 320. The wires 324 may be disposed circumferentially around the valve frame 326 and spaced apart from one another. The wires 324 may be configured to flex inward with the seal skirt 322.

[0142] FIG. 36 illustrates an example of a prosthetic valve 330 where the proximal tensioning body includes a ring 332 or similar toroidal shaped member. A distal portion of a seal skirt 334 may be coupled to a portion of a valve frame 336 or to one or more of the distal anchors 338. The seal skirt 334 may be disposed radially outward from the valve frame 336 with a space between the seal skirt 334 and the valve frame 336, where the seal skirt 334 is in tension and configured to flex to conform to the shape of the native valve. The ring 332 may be configured similarly to the ring 290 shown in FIG. 31. FIG. 37, for example, illustrates a top view of the ring 332, where the ring 332 may have overlapping end portions.

[0143] In an example, the seal skirt may include a pocket within which a ring or other configured tensioning member may be disposed. FIG. 38, for example, illustrates a cross-sectional view of a prosthetic valve 340 including a seal skirt 344 disposed radially outward from a valve frame 346 and a pocket 348 extending around a periphery of the valve 340. A ring 332 may be disposed within the pocket 348 and may be configured to support the seal skirt 344. The ring 332 may include a proximal tensioning body configured to apply tension to the seal skirt 344.

[0144] 27. The valve frame 346 may be configured similarly to the valve frame 262 described with respect to FIG. 27. The valve frame 346 may surround a flow channel 350, where one or more prosthetic leaflets may be coupled to the valve frame 346 and may extend radially inward from the valve frame 346 and may be disposed within the flow channel 350. The prosthetic leaflets may extend radially inward from the valve frame 346 and may be disposed within the flow channel 350. The valve frame 346 may support the prosthetic leaflets within the flow channel 350.

[0145] One or more distal anchors 352 may be coupled to a distal portion of the valve frame 346. The distal anchors 352 may be configured similarly to the distal anchors 17 described with respect to FIG. 1. The distal anchors 352 may have, for example, a hook-like configuration. The distal anchors may be configured, for example, to hook onto the distal tips of the native leaflets to anchor the prosthetic valve 340 to the implantation site. In examples, various other configurations for the anchors 352 may be utilized.

[0146] The seal skirt 344 may include a distal portion 354 coupled to one or more distal anchors 352 and a proximal portion 356 that includes the pocket 348. The proximal portion 356 of the seal skirt 344 may further be coupled to a proximal portion of the valve frame 346.

[0147] The pocket 348 may include overlapping material of the seal skirt 344. For example, as shown in FIG. 38, the pocket 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 pocket 348 may extend parallel to one another. The space between the first portion 358 and the second portion 360 may include a cavity for receiving the ring 332. Each of the first portion 358, the second portion 360, and the ring 332 may extend circumferentially around the valve frame 346 such that the cavity and the pocket 348 have an annular shape around the valve frame 346. The pocket 348 may function to position the ring 332 in a desired position relative to the seal skirt 344.

[0148] The seal skirt 344 may be in tension and may be configured to flex to conform to the shape of the native valve.

[0149] In examples, a distal portion of the seal skirt may be coupled to one or more slidable couplers, each slidable coupler configured to slide relative to one or more anchors. FIG. 39, for example, illustrates a prosthetic valve 361, where the prosthetic valve 361 includes one or more slidable couplers 362. The one or more slidable couplers 362 may be configured to couple a distal portion 354 of the seal skirt 344 to one or more distal anchors 352 and allow the distal portion 354 of the seal skirt 344 to slide relative to the distal anchors 352.

[0150] The seal skirt 344 may be configured similarly to the seal skirt 344 described with respect to FIG. 38 and may or may not include the pocket 348 described with respect to FIG. 38. The seal skirt 344 may be disposed radially outward from the valve frame 346. The seal skirt 344 may be in tension and configured to flex to conform to the shape of the native valve. The valve frame 346 may be configured similarly to the valve frame 346 described with respect to FIG. 38. The valve frame 346 may surround the flow channel. The valve frame 346 may support one or more prosthetic leaflets, which may extend radially inward from the valve frame 346 and may be disposed within the flow channel.

[0151] The distal anchors 352 may be configured similarly to the distal anchors 352 described with respect to FIG. 38. The distal anchors 352 may be configured to anchor the prosthetic valve leaflets to the native valve. Each of the distal anchors 352 may include an elongate arm. The elongate arm may extend radially outward to a tip 363 of the elongate arm.

[0152] 40 , each of the slidable couplers 362 may include a ring. The ring may surround a respective one of the one or more anchors 352 and may be configured to slide along the one or more anchors 352. The slidable couplers 362, in examples, may be configured to slide radially inward along the length of the one or more anchors 352 and may be configured to slide radially outward along the length of the one or more anchors 352.

[0153] For example, the distal anchor 352 may include a long arm and the slidable coupler 362 may be configured to slide along the length of the long arm. The slidable coupler 362 may, for example, slide away from the tip 363, i.e., slide radially inward relative to the tip 363 of the long arm, as shown in FIG. 40. The slidable coupler 362 may slide away from the tip 363 to increase the size of a protruding portion 364 of the long arm located between the slidable coupler 362 and the tip 363. The protruding portion 364 may overlap the distal tip of the native valve leaflet. The size of the protruding portion 364 may be increased to match the shape of the native valve.

[0154] 40 , the leaflets 82 may have a greater length or thickness to allow the slidable coupler 362 to slide radially inward and away from the tip 363. Thus, the size of the protruding portion 364 may be increased to match the size of the leaflets 82 between the tip 363 and the seal skirt 344. Thus, the distal portion 354 of the seal skirt 344 may slide relative to the anchor 352. The distal portion 354 of the seal skirt 344 may slide radially inward and contact the leaflets 82 to form a seal against the leaflets 82.

[0155] Thus, the movement of the slidable coupler 362 may accommodate various configurations of the native valve, thereby allowing sealing even when the native valve has a larger size, as shown in FIG. 40. In an example, the slidable coupler 362 may slide radially inward a shorter distance when the native valve has a relatively small size. FIG. 41 illustrates, for example, the slidable coupler 362 slid radially inward a shorter distance compared to the distance shown in FIG. 40. Such a configuration may be due to the length or size of the leaflets 82 being smaller compared to that shown in FIG. 40. Thus, the slidable coupler 362 may accommodate various sizes of native valves.

[0156] In an example, the slidable coupler 362 may be configured to slide radially outward. Movement of the slidable coupler 362 may pull the seal skirt 344 radially outward in the case of a smaller native valve size.

[0157] The prosthetic valve 361 may be deployed relative to the native valve, and the slidable coupler 362 may automatically slide to conform to the shape of the native valve. The slidable coupler 362 may, for example, slide inward or outward depending on the shape of the native valve.

[0158] In an example, the slidable coupler 362 may be controlled during or after deployment to adjust the position of the slidable coupler 362. Such adjustments may be made in vivo. The deployment may be imaged and the slidable coupler 362 may be slid to take into account the size and shape of the native valve. In an example, the slidable coupler 362 may be adjusted prior to insertion into the patient's body.

[0159] In examples, the slidable coupler 362 may have a configuration other than a ring. For example, sliding rails, magnetic couplings, or other configurations of slidable couplers may be utilized as desired.

[0160] 42 illustrates a prosthetic valve 370 that includes one or more anchors 372, each including a coil 374. The coils 374 may form elongate arms that extend radially outward from a valve frame 376 of the prosthetic valve 370.

[0161] Each coil 374 may include a first or inner portion 378 coupled to the valve frame 376 and a second or outer portion 380 extending radially outward from the inner portion 378. Each coil 374 may extend from a proximal portion of the valve body, including the valve frame 376. The coils 374 may include flexible elongate arms configured to flex to conform to the shape of the native valve. With reference to the schematic plan view shown in FIG. 43, the anchors 372 may be circumferentially spaced apart from one another and each may extend radially outward from the valve frame 376.

[0162] In examples, coil 374 may have uniform flexibility along the length of coil 374 or may include one or more portions that may have varied flexibility. Coil 374 may have portion 382 that may have greater flexibility compared to radially outer portion 384 of coil 374 and compared to radially inner portion 386 of coil 374, for example. Coil 374 may thus be configured to flex inwardly and / or outwardly about portion 382 as desired.

[0163] In an example, each anchor 372 may be configured similarly to anchor 120 described with respect to Figures 11 and 12. For example, anchor 372 may include one or more coil portions, stiffening arms, and / or a cover, such that anchor 372 may be similar to anchor 120 described with respect to Figures 11 and 12. In an example, anchor 372 may include only coil 374.

[0164] The anchor 372 may include a proximal tensioning body that may be coupled to and tension the seal skirt 388. For example, the portion 382 of the coil 374 may be coupled to a proximal portion of the seal skirt 388 and support the seal skirt 388 for sealing against the native valve. The seal skirt 388 may be disposed radially outward from the valve frame 376 with a space between the seal skirt 388 and the valve frame 376, with the seal skirt 388 in tension and configured to flex to conform to the shape of the native valve. The distal end of the seal skirt 388 may be coupled to a distal anchor 390 or may be coupled to another portion of the prosthetic valve 370 as desired.

[0165] FIG. 43 is a schematic plan view of a prosthetic valve 370 illustrating one exemplary configuration for anchors 372, spaced about the periphery.

[0166] The anchors 372 may include proximal or atrial anchors that may anchor the prosthetic valve 370 within the atrium of the heart. Figure 44, for example, illustrates the prosthetic valve 370 deployed against the native valve 80 and anchored against the native valve leaflets 82. The anchors 372 may extend proximally and may contact the atrial wall or a portion of the native valve on the atrial side of the valve. The anchors 372 may be flexible to reduce damage or potential conduction disturbances with respect to the native valve.

[0167] In an example, the distal anchor 390 may anchor the prosthetic valve 370 to the native valve in a manner similar to the distal anchor 17 described with respect to Figure 1. The distal anchor 390 may include a hook-like anchor disposed at a 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.

[0168] FIG. 45 illustrates an example of a prosthetic valve 400 that includes one or more anchors 402 configured to anchor the prosthetic valve leaflets to the native valve, the one or more anchors 402 including a structure generally shaped as a T-bar 404.

[0169] The prosthetic valve 400 may include a valve frame 406 that surrounds a flow channel 408. One or more prosthetic valve leaflets may be disposed within the flow channel 408 and supported by the valve frame 406. A seal skirt 410 may be disposed radially outward of the valve frame 406 and supported by the anchors 402. The seal skirt 410 may have, for example, a proximal portion and a distal portion, and the anchors 402 may include a proximal tensioning body coupled to the proximal portion of the seal skirt 410 and configured to apply tension to the seal skirt 410.

[0170] 46, each T-bar 404 may include a crossbar 412 and a stem 414. The stem 414 may extend the crossbar 412 radially outward from the valve frame 406. Each stem 414 may be coupled to a proximal portion of the valve frame 406. The crossbar 412 may be disposed radially outward from the stem 414. The crossbar 412 may extend transversely relative to the stem 414. The crossbar 412 may include a support that may support the seal skirt 410 in tension.

[0171] 47 , each T-bar 404 may be circumferentially spaced apart from one another around the valve frame 406. The crossbars 412 of the multiple anchors 402 may form a ring that extends circumferentially around the prosthetic valve. A segmented flange that extends circumferentially around the prosthetic valve may be formed by the crossbars 412 of the multiple anchors 402. Each T-bar 404 may be disposed at a proximal portion of the valve frame 406 and may extend radially outward from the proximal portion of the valve frame.

[0172] In an example, each T-bar 404 may be configured to deflect radially inward. FIG. 48, for example, illustrates a top view of a T-bar 404, with the arms of the crossbar 412 extending circumferentially outward relative to the stem 414. The crossbar 412 may include a central portion 413 coupled to the stem 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 outward in a circumferential direction. In an example, the arms 415, 417 of the crossbar 412 may be biased inwardly toward the stem 414, for example, as shown in FIG.

[0173] The stem 414 may include a straight stem 414 or, in examples, may include undulations. Figure 50 illustrates a variation on the stem 416, for example, including undulations configured to provide flexibility to the stem 416. The undulations may increase the flexibility of the stem 416. Thus, the flexibility of the T-bar may be increased.

[0174] The anchors 402 may include a proximal or atrial anchor that may support the prosthetic valve 400 within the native valve. The anchors 402 may be configured to be flexible to allow the anchors 402 to conform to the shape of the native valve.

[0175] In an example, the prosthetic valve 400 may include one or more distal anchors 418. The distal anchors 418 may be disposed at a distal portion of the valve frame 406. The distal anchors 418 may be configured similarly to the distal anchors described with respect to FIG. 1. The distal anchors 418 may be configured to hook onto the distal tips of the native valve leaflets, for example, to anchor the distal anchors 418 to the native valve. In an example, the distal anchors 418 may be coupled to a distal portion of the seal skirt 410 and may provide tension to the seal skirt 410.

[0176] In an example, the distal anchor 418 may be circumferentially disposed between two proximal anchors including adjacent T-bars 404. FIG. 51 illustrates such a configuration, for example, with the distal anchor 418 and the T-bar 404. The sealing skirt 410 may extend between the distal anchor 418 and the valve frame 406 and may extend circumferentially outboard of the adjacent T-bar 404. Thus, when the distal anchor 418 fails to capture a leaflet, the anchor may be disposed inboard of the outer extent of the T-bar 404. Thus, the sealing skirt 410 over the T-bar 404 may provide a seal at the portion of the native valve that failed to capture the native leaflet.

[0177] FIG. 52, for example, illustrates a side perspective view showing distal anchors 418 disposed between circumferentially adjacent T-bars 404.

[0178] The prosthetic valves disclosed with respect to Figures 27-52 may include single frame prosthetic valves or may have other configurations as desired. Each feature in the examples of Figures 27-52 may be used alone or in combination with any other examples disclosed herein.

[0179] 53 illustrates one example of a prosthetic valve 430 in which the sealing skirt 432 forms a disk-shaped structure that extends along the length of each elongate anchoring arm 434. The disk-shaped structure can be continuous around the periphery and can extend between adjacent anchoring arms 434.

[0180] The prosthetic valve 430 may include a valve body 431 supporting one or more prosthetic leaflets (e.g., as shown in FIG. 2). The valve body 431 may include a frame as shown in FIG. 53, or may have another configuration, as desired. A number of distal anchors, in the form of anchor arms 434, may be provided.

[0181] The anchoring arms 434 may include elongate 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 elongate arm. Each elongate anchoring arm 434 may be configured to hook onto a distal tip of a native leaflet to anchor one or more prosthetic leaflets to the native valve. Thus, the sealing skirt 432 may extend along the anchoring arms 434 and be positioned radially outward of the native leaflets. FIG. 54, for example, illustrates a position of the sealing skirt 432 radially outward of the native leaflets.

[0182] In an example, the sealing skirt 432 may be coaxial with each elongate anchor arm 434. The sealing skirt 432 shown in Figures 53 and 54 may fit closely along the elongate anchor arm 434 and may extend along the length of the arm 434. Each elongate anchor arm 434 may have a curved portion 437 and the disk formed by the sealing skirt 432 may extend along the curved portion 437.

[0183] The radially outer extent of the seal skirt 432 may vary. In examples, the seal skirt 432 may extend from the first end 433 of the anchor arms 434 to the tip 435 of each anchor arm 434. In examples, a shorter extent (e.g., along only a portion of the anchor arms 434) may be provided. The seal skirt 432 may still extend along the anchor arms 434 such that the seal skirt 432 is located radially outward of the native leaflets.

[0184] The sealing skirt 432 may include a disc having a convex curvature, as shown in Figure 53. The sealing skirt 432 may extend entirely around the valve body 431 in a circumferential direction and may form a continuous disc around the valve body 431.

[0185] In an example, the sealing skirt 432 may be coaxial with the frame of the valve body 431. For example, as shown in FIG. 53, the sealing skirt 432 may extend proximally along the frame to a proximal portion and end of the frame. The sealing skirt 432 may continue distally along the frame and may be continuous with the portion of the sealing skirt 432 that extends along the anchor arms 434. In an example, the prosthetic valve may include a single-frame prosthetic valve.

[0186] An improved seal may be provided based on the seal skirt 432 extending along the anchor arms 434 and forming a disk configuration. A smaller compression profile may also be provided.

[0187] The frame may have a shape that includes a shoulder or hourglass shape to reduce the likelihood of the prosthesis migrating into the ventricle. The hourglass shape is also advantageous because the prosthesis leaflets fit against the inner walls of the hourglass, thereby reducing any gaps between the prosthesis leaflets and the frame when the prosthesis is in an open configuration to allow blood to pass through the prosthesis 430. Eliminating gaps reduces the amount of pooled blood, which reduces the likelihood of clot formation.

[0188] In an example, the chordae of the ventricle may be severed to allow the disks to extend around the native valve leaflets. The chordae may be severed prior to deployment of the prosthetic valve to reduce the possibility of interference between the chordae and the sealing skirt 432. In an example, the sealing skirt 432 may include one or more slits to allow deployment of the prosthetic valve without severing the chordae. In an example, the chordae may be disposed within one or more of the slits during deployment.

[0189] Each feature in the examples of Figures 53 and 54 may be used alone or in combination with any other examples disclosed herein.

[0190] 55A illustrates a cross-sectional view of an anchor 440 that may be utilized in the examples herein. The anchor 440 may include a hinge 442 that may be configured to allow the anchor 440 to flex radially.

[0191] The anchor 440 may be configured to be utilized with any of the examples of the prosthetic valves disclosed herein, or with another form of prosthetic valve. The anchor 440 may include an inner or coupling portion 444 that may be coupled to a valve body 446. The valve body 446 may be configured similarly to any of the examples of the valve bodies disclosed herein, or may have another configuration in examples. The valve body 446 may support one or more prosthetic leaflets. The anchor 440 may be coupled to a distal end portion 448 of the valve body 446 in examples, or may be located at another location in examples, as desired.

[0192] The anchor 440, in examples, may include an elongate arm. The coupling portion 444 of the anchor 440, in examples, may be curved and may have a convex curvature in the distal direction. The coupling portion 444 may extend in the distal direction. The coupling portion 444 may be coupled to a tip portion 450 of the anchor 440. The coupling portion 444 may extend the tip portion 450 of the anchor 440 radially outward, thereby increasing the radially outward position of the tip portion 450. In examples, the coupling portion 444 may have other configurations, as desired.

[0193] A tip portion 450 of anchor 440 may extend proximally upon deployment of anchor 440. Tip portion 450 may extend linearly, for example, from junction 443 to coupling portion 444. Tip portion 450 may extend linearly proximally to a tip 452 of anchor 440. Tip 452 may be axially aligned with intermediate portion 454 of valve body 446 or may be located at another location, for example, as desired.

[0194] Hinge 442 may be located at a junction 443 of tip portion 450 to coupling portion 444, or may be located at another location, as desired. In an example, hinge 442 may be located proximally on tip portion 450 and closer to tip 452 than the location shown in FIG. 55A. The portion of anchor 440 proximal to hinge 442, i.e., located on the outside, may comprise the pivot portion of anchor 440, and the portion of anchor 440 distal to hinge, i.e., located on the inside, may comprise the stationary portion of anchor 440. In an example, hinge 442 may be located on coupling portion 444.

[0195] The hinge 442 may be configured to allow the pivoting portion of the anchor 440 to flex radially inward, as shown in FIG. 55B. The hinge 442 may increase the flexibility of the anchor 440 in the radially inward direction. The hinge 442 may be configured to pivot about an axis extending transversely to the longitudinal axis of the prosthetic valve.

[0196] In an example, hinge 442 may be configured to prevent radially outward deflection of anchor 440. Hinge 442 may include, for example, a one-way or unidirectional hinge 442 that may allow radially inward movement and prevent radially outward movement. In an example, the hinge may allow anchor 440 to flex radially outward.

[0197] Anchor 440 may be configured, in an example, to be in a hook-like configuration. Anchor 440 may be configured to extend onto the distal end or tip of the native leaflet for anchoring. Tip portion 450 may be positioned radially outward of the native leaflet in the hook-like configuration.

[0198] The hinge 442 may include a joint or link, for example. The hinge 442 may include a mechanical bearing hinge, for example, as shown in FIGS. 55A and 55B. The mechanical bearing hinge may include multiple members configured to rotate or move relative to one another to allow the hinge to move. The mechanical bearing hinge may include an axle about which the mechanical bearing hinge pivots. In an example, the mechanical bearing hinge may be formed by a connector, such as a suture or fabric, that joins the tip portion 450 to the mating portion 444. In an example, a suture loop may function as the axle. In an example, the hinge may include a living hinge 456, as shown in FIG. 56. The living hinge 456 may include a thinner or weaker portion of the material that makes up the anchor 458, around which the anchor 458 may flex. The thinner or weaker portions may be located on a radially facing surface of anchor 458 (such as a radially inward facing surface as shown in FIG. 56 ) or may be located on one or more side surfaces of anchor 458 (e.g., circumferentially facing surfaces).

[0199] In examples, the hinge may be spring biased to the radially outer position. The spring bias may be overcome by a radially inward force in examples. The spring bias may be generated by a portion of the hinge that includes a spring in examples. The material (e.g., a shape memory material or other form of material) that includes the hinge may include a spring biased material that may be biased to the radially outer position.

[0200] The hinges disclosed herein may allow the anchor to pivot to provide greater conformance of the anchor to the implantation site upon implantation. For example, the anchor may be configured to flex radially inward to conform to the shape of the native heart valve. As a result, radial pressure on the implantation site may be reduced. As a result, the likelihood of electrical conduction interference to native anatomical structures may be reduced. For example, forces on cardiac conduction structures (e.g., the AV node) or on the heart valve annulus may be reduced.

[0201] In examples, the hinges disclosed herein may be configured to allow the anchors to capture or recapture a native valve leaflet that the anchors have failed to capture. The capture or recapture may occur during a deployment sequence of the prosthetic valve, in examples. In examples, the capture or recapture may occur after the deployment sequence.

[0202] The capture or recapture of the native leaflets may occur in response to movement of the native leaflets, which may include, in examples, systolic movement of the native leaflets, which may be utilized in deployment for mitral or tricuspid valves, in examples. The hinges may be configured to allow each corresponding anchor to flex radially inward in response to a radially inward force of the native leaflets.

[0203] For example, Figures 57-62 illustrate the deployment sequence of a prosthetic valve 460 utilizing one or more hinges 442. A prosthetic valve utilizing one of the living hinges 456 may operate in a similar manner.

[0204] 62, the prosthetic valve 460 may be configured similarly to any of the examples of prosthetic valves disclosed herein or similarly to any other form of prosthetic valve. The prosthetic valve 460 may include features similar to the prosthetic valves described, for example, with respect to FIGS. 1-8. The prosthetic valve 460 may include a valve body 446, which may include, for example, an inner valve body 447 or inner frame. The valve body 446 may include a proximal end portion 449 and a distal end portion 448, and the anchors 440 may be coupled to the distal end portion 448 of the valve body 446. One or more anchors 440 may be utilized (multiple anchors 440a,b are shown in FIG. 62). The anchors 440 may extend radially outward from the valve body 446. The anchors 440 may be circumferentially spaced apart from one another.

[0205] The valve body 446 may include a seal body 466 disposed radially outward of the inner valve body 447. The seal body 466 may include a distal end portion 453 and a proximal end portion 455. The proximal end portion 457 of the inner valve body 447 may be coupled to the proximal end portion 455 of the seal body 466. The anchor 440 may be coupled to the distal end portion 459 of the inner valve body 447. The inner valve body 447 may include an inner frame and the seal body 466 may include an outer frame. In an example, a seal skirt may be disposed on the outer frame.

[0206] A distal end portion 459 of the inner valve body 447 may be spaced apart from a distal end portion 453 of the seal body 466 by a gap 461 .

[0207] 57, prosthetic valve 460 is shown in a compressed or crimped configuration within a delivery device capsule 462. In the configuration shown in Fig. 57, anchors 440a,b, each of which may be configured similarly to anchor 440, are shown in an elongated or extended configuration within capsule 462. Prosthetic valve 460 may be in the compressed or crimped configuration for approach to the implantation site.

[0208] The anchors 440a,b may be released from the capsule 462 in embodiments disclosed herein. For example, referring to FIG. 58, the capsule 462 may be driven back and the anchors 440a,b may be allowed to expand radially outward. The anchor 440b may capture the native leaflet 464b and may be positioned radially outward of the native leaflet 464b. However, the anchor 440a may fail to capture the native leaflet 464a and may be positioned radially inward of the native leaflet 464a. Utilizing a hinge 442 on the anchor 440a may allow capture or recapture of the native leaflet 464a. In an example, systolic movement of the leaflet 464a may cause the hinge 442 to pivot, which may allow capture or recapture of the native leaflet 464a.

[0209] Movement of the anchor 440a may occur due to radially inward movement of the leaflet 464a under systolic occlusion movement of the leaflet 464a. The hinge 442 may pivot inwardly to allow the anchor 440a to be positioned radially outward of the leaflet 464a. The leaflet 464a may pass radially inward over the tip of the anchor 440a to be positioned radially inward of the anchor 440a. The hinge 442 may pivot to accommodate the movement of the leaflet 464a.

[0210] 59-61, for example, illustrate such movement of leaflet 464a. With reference to FIG. 59, leaflet 464a is shown as being radially outward of anchor 440a. Prosthetic valve 460 may be in the process of being deployed and may be partially held in a radially inward compressed configuration. Compression of prosthetic valve 460, and in particular compression of outer frame or seal body 466 of prosthetic valve 460, may increase gap clearance 468 between anchor 440a and the body of prosthetic valve 460, which may increase the ability of anchor 440a to rotate radially inward. The space in which the tip of anchor 440a rotates may be increased.

[0211] During deployment, the leaflets 464a,b may move in accordance with the diastolic and systolic movements. The leaflet 464b may be constrained by the anchor 440b from moving radially outward during diastole. However, the leaflet 464b may be allowed to move radially inward during systole. The leaflet 464a may move radially inward during systole. The inward movement of the leaflet 464a may drive the hinge 442 on the anchor 440a to pivot radially inward. The leaflet 464a may move radially inward of the anchor 440a, for example, as shown in FIG. 60. The leaflet 464a may move radially inward, in an example, beyond the tip 452 of the anchor 440a.

[0212] The configuration of hinge 442 on anchor 440a may prevent radial outward movement of leaflet 464a during diastole, and thus leaflet 464a may be captured by anchor 440a, as shown in FIG.

[0213] The prosthetic valve 460 may be fully deployed, as shown in Figure 62. The anchors 440a, 440b may capture corresponding leaflets 464a, 464b, respectively.

[0214] In examples, anchors 440a,b may be configured to flex radially outward. The hinges utilized may be configured to allow radially outward movement, for example. Radially outward movement may increase the flexibility and compliance of anchors 440a,b during implantation. In examples, other configurations may be utilized.

[0215] In examples, the anchors disclosed herein may include a visual indicator under medical imaging as to whether a leaflet is captured. The radial inward movement of the anchor may include an indication that capture of the leaflet has not occurred. The medical imaging may include ultrasound (e.g., echocardiography), or fluoroscopy, or a combination of ultrasound and fluoroscopy, or other forms of medical imaging. The anchors may include fluoroscopy markers in examples. The anchors may be visualized to determine whether a leaflet is captured or has missed capture.

[0216] Each feature in the examples of Figures 55A-62 may be used alone or in combination with any other examples disclosed herein.

[0217] 63-67 illustrate an example of a frame that may be utilized in each of the examples herein. The frame may include an inner frame 480, for example, as shown in FIG. 63. The inner frame 480 may be configured to support one or more prosthetic leaflets, similar to other examples of inner frames disclosed herein. The inner frame 480 may include a proximal end portion 481 and a distal end portion 483. The frame may include an outer frame 482, for example, as shown in FIG. 64.

[0218] The outer frame 482 may include one or more anchors 484 that may be configured to anchor the frame to an implantation site. The one or more anchors 484 may be coupled to the outer frame 482 and configured to be positioned radially outward of one or more leaflets of the native valve to anchor the native valve. The anchors 484 may include anchors having a hook-like configuration, or may include anchors of other forms, in examples.

[0219] The outer frame 482 may include a proximal end portion 486 and a distal end portion 488. The anchors 484 may be disposed at the distal end portion 488 of the outer frame 482, in examples. The outer frame 482 may include a plurality of struts having a lattice structure. The struts of the outer frame 482, in examples, may form a plurality of distal apices 490. The anchors 484 may extend distally from the apices 490. In examples, other arrangements may be utilized.

[0220] Each anchor 484 may include a connecting portion 493 and a tip portion 495. The connecting portion 493 may be connected to the outer frame 482, and the tip portion 495 may be configured to extend proximally from the connecting portion 493. The connecting portion 493 may be connected to a distal end portion 488 of the outer frame 482. The connecting portion 493 may be connected to a respective one of the distal apices 490, in an example. The connecting portion 493 may have a convex curvature in the distal direction (as shown in FIG. 64 ), or may have another configuration, in an example, as desired. The tip portion 495 may extend linearly from the connecting portion 493, in an example.

[0221] 65 illustrates a perspective view of an inner frame 480 coupled to an outer frame 482. A proximal end portion 481 of the inner frame 480 may be coupled to a proximal end portion 486 of the outer frame 482.

[0222] 66 illustrates a side view of an inner frame 480 coupled to an outer frame 482. The outer frame 482 may be disposed radially outward from the inner frame 480 and may surround the inner frame 480. A distal end portion 483 of the inner frame 480 may be spaced apart from a distal end portion 488 of the outer frame 482 with a gap 487, in examples.

[0223] 67 illustrates a top view of an inner frame 480 coupled to an outer frame 482. The anchors 484 are shown as projecting radially outward from the outer frame 482. The anchors 484 may be circumferentially spaced apart from one another.

[0224] During deployment, anchors 484 may be utilized, in examples, to extend over and be positioned radially outward of the native leaflets for anchoring. FIGURE 68, for example, illustrates a prosthetic valve 491 deployed relative to a native valve, with anchors 484 positioned radially outward of the native leaflets 492a,b. A sealing skirt 497 may be positioned over an outer frame 482, in examples, as disclosed herein.

[0225] The prosthetic valve 491 may include one or more prosthetic leaflets, similar to the other examples of prosthetic valves disclosed herein. The prosthetic valve 491 may be configured similar to each of the examples of prosthetic valves disclosed herein, unless otherwise noted.

[0226] The outer frame 482 may advantageously include anchors 484 such that the inner frame 480 receives pressure loads (directed against movement of the prosthetic leaflets) and the outer frame 482 receives anchoring loads. In this manner, the inner frame 480 receives less loads acting against itself compared to a configuration in which the inner frame includes anchors (e.g., as shown in FIG. 3). The inner frame may also have a reduced compressive strain acting against itself during a compressive operation.

[0227] In an example, the outer frame may have a thinner thickness 494 (shown in FIG. 69 ) in a radial dimension (radial thickness) compared to a thickness 496 (shown in FIG. 69 ) of the inner frame in a radial dimension. Thus, the anchor 484 may have a thinner thickness 494 than the thickness 496 of the inner frame. The thinner thickness 494 of the outer frame and anchor may allow the anchor to be molded into a tighter or smaller radius of curvature compared to a thicker frame. For example, an anchor having the same thickness as the outer frame may be molded into a tighter or smaller radius of curvature compared to an anchor having the same thickness as the inner frame. A thinner anchor may also exert less force on the implantation site. As a result, for example, forces on a heart valve annulus may be reduced. As a result, the likelihood of electrical conduction problems may be reduced.

[0228] In an example, the anchor 498 may be configured to clamp with a portion of a prosthetic valve. The anchor 498 may be configured to clamp the leaflet between the anchor 498 and a portion of the prosthetic valve to anchor the leaflet. FIG. 69 illustrates an arrangement in which the anchor 498 is configured to secure the leaflet between the anchor 498 and an outer frame 500, for example, to clamp the leaflet between the anchor 498 and an outer frame 500. The anchor 498 may provide a radially inward force against the leaflet to press the leaflet against the outer frame 500.

[0229] The anchors 498 may be biased radially inward relative to the outer frame 500. The anchors 498 may include, for example, a distal loop portion 502 that may be angled proximally relative to a tip portion 504 of the anchor 498 and may cause the tip portion 504 to be directed radially inward toward the outer frame 500. The tip portion 504 may include a clamping portion configured to abut and clamp against the outer frame 500. The seal skirt 501 may be coupled to the outer frame 500, in examples.

[0230] The anchors 498 may be held in an elongated configuration prior to deployment (similar to the configuration shown in FIG. 57). The tip portion 504 may extend distally. The anchors 498 may be released to extend radially outward and may reverse position to extend proximally (as shown in FIG. 70). The anchors 498 may be positioned radially outward of the leaflets 492a and rotated toward the outer frame 500 for clamping. The anchors 498 may press the native leaflets 492a radially inward and against the outer frame 500, as shown in FIG. 70. The native leaflets 492a may be clamped in place and such clamping may resist proximal movement of the prosthesis (i.e., atrial movement) and distal movement of the prosthesis (i.e., ventricular movement). This may result in improved anchoring to the implantation site.

[0231] Each feature in the examples of Figures 63-70 may be used alone or in combination with any other example disclosed herein.

[0232] 71-76 illustrate an example of the anchors 510 extending proximally. The anchors 510 may include an elongated arm that may extend linearly, in an example. Each of the anchors 510 may include a lever arm that may include a counter lever portion 512 located opposite the fulcrum 514. A tip portion 516 of the anchors 510 may extend proximally from the fulcrum 514. The anchors 510 may be configured such that a radially inward force applied to the counter lever portion 512 causes the tip portion 516 of the anchor 510 to pivot radially outward about the fulcrum 514 and further increases the distance of the tip portion 516 from the outer frame 520. The anchors 510 may be biased to move the tip portion 516 radially inward when the radially inward force applied to the counter lever portion 512 is reduced. Anchor 510 may be configured to be actuated to change the radial position of anchor 510. Anchor 510 may be coupled to frame 520, in examples, via sutures or via other forms of coupling. Anchor 510 may be coupled to a distal apex of frame 520 or to other portions, as desired.

[0233] The counter lever portion 512 may include one or more actuator couplers 522, which may be configured to couple to an actuator assembly, which may include a component of a delivery system, and may be utilized to drive the anchor 510 during a deployment procedure, as desired. The actuator couplers 522 may include, for example, eyelets configured to engage one or more tethers of the actuator assembly, or may have another configuration, as desired. The actuator couplers 522 may be disposed at a distal end portion of the outer frame 520, as an example. The actuator couplers 522 may be configured to be pulled radially inward by the actuator assembly, thereby deflecting the tip portion 516 of the anchor 510 radially outward.

[0234] The outer frame 520 may include a number of struts 521 forming a lattice structure. The lattice structure may have a number of openings 524. A tip portion 516 of the anchor 510 may, in example, be aligned with an opening 524 bounded by one or more struts in the outer frame 520. The position of the anchor 510 may allow the anchor 510 to be retracted radially inward and reduce the outer diameter of the prosthetic valve in a compressed or crimped configuration.

[0235] 72 illustrates a side cross-sectional view illustrating the position of anchor 510. A tip portion 516 of anchor 510 may extend proximally.

[0236] 73-76 illustrate an exemplary deployment sequence for a prosthetic valve utilizing an outer frame 520 and anchors 510. FIG. 73 illustrates the prosthetic valve in a compressed or crimped configuration within a capsule 526 of a delivery system. The anchors 510 may extend proximally with tip portions 516 extending proximally from fulcrum 514. Tip portion 516 of each anchor 510 is configured to extend proximally when the prosthetic valve is in the crimped configuration.

[0237] Each of the anchors 510 may be configured to be actuated to deflect tip portion 516 radially outward from outer frame 520 .

[0238] In an example, the anchor 510 may be actuated by utilizing an actuator assembly 530. The actuator assembly 530 may include, for example, one or more tethers 532 configured to engage with the couplers 522. The tethers 532 may include, for example, a cord, cable, wire, or other form of tether. The tethers 532 may form a loop with two lengths extending through the delivery system. Thus, a length of the tether 532 may be cut to allow the tethers 532 to be pulled from the couplers 522 to release them from their respective couplers 522. The actuator assembly 530 may include a shaft 534 that may engage with the tethers 532. The shaft 534 may include a sheath or shroud that may extend over the tethers 532 and allow the tethers 532 to be pulled and released to actuate the anchor 510.

[0239] FIG. 74 illustrates the prosthetic valve partially released from the capsule 526. The actuator assembly 530 may be actuated to apply a radially inward force to the counter lever portion 512 of the anchor 510. The tether 532 may, for example, be pulled radially inward to pull the counter lever portion 512 radially inward. The radially inward movement of the counter lever portion 512 may cause the tip portion 516 to extend radially outward. The tip portion 516 may be positioned radially outward of the native leaflets to a position for anchoring the leaflets. In an example, the prosthetic valve may be positioned distal to the native annulus, or may be actuated distally to allow the tip portion 516 to hook onto or be positioned radially outward of the native leaflets. In an example, the prosthetic valve may be actuated proximally back to seat the native leaflets onto the tip portion 516.

[0240] The prosthetic valve may continue to be released and expanded as shown in FIG. 75. The actuator assembly 530 may continue to apply a radially inward force to the counter lever portion 512. The tip portion 516 may be in a radially outward expanded state. The actuator assembly 530 may be released to allow the tip portion 516 to move radially inward as shown in FIG. 76. The anchors 510 may anchor the prosthetic valve in place. The anchors 510 may apply a clamping force against the native leaflets. The anchors 510 may clamp the native leaflets against the outer frame 520. The anchors 510 may press the native leaflets against a seal skirt disposed on the outer frame 520 and covering the openings 524 as shown in FIG. 71. The anchors 510 may apply a clamping force to another position as desired. The clamping force may resist proximal movement of the prosthetic valve (ie, toward the atrium) or may resist distal movement of the prosthetic valve (ie, toward the ventricle).

[0241] Each feature in the examples of Figures 71-76 may be used alone or in combination with any other examples disclosed herein.

[0242] 77-84 illustrate a frame 540 that may be utilized in the examples herein for a prosthetic valve. Frame 540 is shown in an expanded or deployed configuration in FIG. 77. Frame 540 may include an inner frame 542 and may include an outer frame 544. Inner frame 542 is shown separated from outer frame 544 in FIG. 82. Outer frame 544 is shown separated from inner frame 542 in FIG. 83.

[0243] The portion of the frame 540 including the inner frame 542 and the outer frame 544 may be cut from a single piece of material, for example. Thus, the outer frame 544 may be integral or one-piece with the inner frame 542, for example. The portion of the frame 540 including the inner frame 542 and the outer frame 544 may be formed by cutting a material having a cylindrical shape. The outer frame 544 may be biased radially outward from the inner frame 542. The outer frame 544 may be biased outward and shaped, for example, to be located outside the inner frame 542, for example.

[0244] The inner frame 542 may have a cylindrical shape in an expanded or deployed configuration as shown in FIG. 77. The inner frame 542 may include a plurality of struts 546. The plurality of struts 546 may surround a plurality of openings 548. The struts 546 may be formed into a lattice structure, in an example, with a plurality of struts 546a-d forming a strut cell. An exemplary strut cell is shown in FIG. 77 as including four struts 546a-d forming a diamond shape and surrounding an opening 548. The strut cell may include, in an example, a closed strut cell that is completely surrounded by the struts 546a-d. Three such strut cells are shown in FIG. 77 as being circumferentially spaced apart from one another. In an example, the inner frame may include a circumferentially extending strut 546e that may join the strut cells to one another. In an example, other configurations for the inner frame 542 may be utilized.

[0245] The inner frame 542 may be configured to support one or more prosthetic leaflets, in examples. FIGURE 77 illustrates a configuration that may be utilized for three prosthetic leaflets. The commissures of the prosthetic leaflets may be disposed in each of the three strut cells in the inner frame 542 shown in FIGURE 77.

[0246] The outer frame 544 may include a plurality of struts 550. The struts 550 may be formed into a lattice structure, in an example, with a plurality of struts 550a-d forming a strut cell. An example strut cell is shown in FIG. 77 as including a plurality of struts 550a-d forming a diamond shape and surrounding an opening 552. Three such strut cells are shown in FIG. 77 as being spaced apart from one another in a circumferential direction. In an example, the outer frame may include smaller strut cells 554, 556 extending proximally and distally, respectively, from a central or intermediate portion of the outer frame 544. The smaller strut cells 554, 556 may be circumferentially disposed between the larger strut cells. Three pairs of smaller strut cells 554, 556 are shown in FIG. 77 as being circumferentially disposed between adjacent larger strut cells.

[0247] Each of the outer frame 544 and the inner frame 542 may include circumferentially extending struts 546e.

[0248] At least a portion of the inner frame 542 is aligned within at least one of the plurality of openings 552 in the outer frame 544. The strut cells formed by struts 546a-d are aligned within the openings 552 of the outer frame 544 bounded by struts 550a-d, for example. Figure 79 illustrates such alignment, for example. The strut cells formed by struts 546a-d may include blocked strut cells. The diamond shaped strut cells of the inner frame 542 may be aligned within the diamond shaped strut cells of the outer frame 544.

[0249] FIG. 78 illustrates a perspective view of frame 540 rotated from the position shown in FIG.

[0250] 79 illustrates a side view of the frame 540. The outer frame 544 may 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, with the proximal portion 558 flaring radially outward from the central portion 560 of the outer frame 544. The distal portion 562 of the outer frame 544 flaring radially outward from the central portion 560 of the outer frame 544. The central portion 560 may include a narrow portion or waist portion disposed between the proximal portion 558 and the distal portion 562.

[0251] Figure 80 illustrates a side view of the frame 540 rotated from the position shown in Figure 79. The inner frame 542 may have a cylindrical shape in the expanded configuration (as shown more clearly in Figure 82). In examples, the inner frame 542 may have other configurations, including a non-cylindrical or asymmetric profile.

[0252] Figure 81 illustrates a top view of the frame 540. Figure 82 illustrates an isolated view of the inner frame 542 without showing the outer frame 544. Figure 83 illustrates an isolated view of the outer frame 544 without showing the inner frame 542.

[0253] Frame 540 may be configured to expand radially outward from a crimped or compressed configuration to an expanded configuration. Each of inner frame 542 and outer frame 544 may have a cylindrical shape in the crimped or compressed configuration.

[0254] The configuration of the frame 540, cut from a single piece of material, may allow the frame 540 to be transitioned to a crimped or compressed configuration in which the strut cells of the inner frame 542 may be positioned within the openings of the strut cells of the outer frame 544. Such a configuration is shown, for example, in FIG. 84. At least a portion of the inner frame 542 is located within at least one opening of the outer frame 544 when the frame 540 is in the crimped or compressed configuration. The location of the inner frame 542 within the openings of the strut cells of the outer frame 544 may allow the outer diameter of the prosthetic valve to be reduced because the outer frame is not stacked onto the inner frame, such as in the configuration shown in FIG. 5. FIG. 85 illustrates a view of the frame 540 in a crimped or compressed configuration, for example, in a rotated view from that shown in FIG. 84.

[0255] Figure 86 illustrates a schematic plan view of the frame 540 in a crimped or compressed configuration. The outer frame 544 (shown in Figure 85) is of the same diameter, i.e., located at the same radial distance, as the inner frame 542 in such a configuration. The frames may circumscribe a central axis 563 of the prosthetic valve.

[0256] Variations on the frame 540 may be employed. FIG. 87 illustrates, for example, a configuration in which one or more distal anchors 564 may be coupled to the outer frame 566. The distal anchors 564 may be coupled to distal apexes of struts of the outer frame 566, in examples. The distal anchors 564 may form hooks for anchoring to the native valve. The distal anchors 564 may have a hook-like configuration. The frame 568 may otherwise be configured similarly to the frame 540. The distal anchors 564 may be configured to be positioned radially outward of the native valve leaflets, in examples.

[0257] FIG. 88 illustrates a variation in which a distal anchor 570 may be coupled to an inner frame 572. The distal anchor 570 may be coupled to a distal apex of a strut of the inner frame 572, in an example. The distal anchor 570 may form a hook for anchoring to the native valve. The distal anchor 570 may have a hook-like configuration. The cells of the outer frame 578 may include open strut cells with notches 580 that may allow the distal anchor 570 to pass radially outward for anchoring. The notches 580 may also allow the frame 582 to have a uniform diameter when crimped or compressed (e.g., as shown in FIG. 86). At least a portion of the inner frame 572 may be aligned with at least a portion of the plurality of open strut cells. The frame 582 may otherwise be configured similarly to the frame 540.

[0258] FIG. 89 illustrates a schematic diagram of the location of the notch 580 relative to the distal anchor 570 to allow passage through the outer frame 578.

[0259] Anchors 564, 570 may extend distally and each may comprise a distal anchor of a corresponding frame.

[0260] In examples, the anchors 564, 570 may be configured to form hooks to clamp the leaflets of the native valve. The anchors 564, 570 may clamp the leaflets to a portion of the frame in the manner disclosed with respect to FIG. 70 or in another manner as desired. The anchors 564, 570 may clamp the leaflets to a respective outer frame in examples.

[0261] In an example, upon deployment, the outer frame 544 may include anchor bodies that may be utilized to anchor the prosthetic valve 590 to an implantation site. FIG. 90, for example, illustrates a deployed configuration of the prosthetic valve 590. The proximal portion 558 of the outer frame 544 may include a proximal anchor and the distal portion 562 of the outer frame 544 may include a distal anchor. The proximal anchor may be disposed on the atrial side of the native valve. The distal anchor may be disposed on the ventricular side of the native valve. The flared shapes of the proximal portion 558 and the distal portion 562 may function to impede the prosthetic valve 590 from moving within the ventricle and atrium, respectively.

[0262] In an example, a seal skirt 592 may be disposed on the frame 540. The seal skirt 592 may extend over the openings in the struts to cover and seal against fluid flow therethrough. The prosthetic valve 590 may include one or more prosthetic leaflets 596. In an example, an interior portion of the seal skirt 592 may surround a flow channel 594 of the prosthetic valve 590 within which the prosthetic leaflets 596 may be disposed. The prosthetic leaflets 596 may be sutured or otherwise attached to the seal skirt 592.

[0263] Variations regarding the frame 540 and prosthetic valve 590 may be employed. Figures 91-93 illustrate variations, such as where the struts forming the inner frame 542 of Figure 77 are deflected radially outward to form the outer frame 600, while the struts forming the outer frame 544 of Figure 77 are maintained in a cylindrical configuration to form the inner frame 602. Thus, the cells of the outer frame 600 may, for example, be aligned with the openings 604 of the cells of the inner frame 602. In the compressed or crimped configuration, the frame may have the configuration shown, for example, in Figures 84 and 85. At least a portion of the outer frame 600 is located within at least one opening of the inner frame 602 when the frame is in the crimped configuration.

[0264] 91 illustrates a side view of a cell of the outer frame 600 aligned within an aperture 604 of the inner frame 602. At least a portion of the outer frame 600 is aligned within at least one of the apertures 604 of the inner frame 602. The strut cells formed by struts 601a-d (corresponding to struts 550a-d shown in FIG. 77) of the inner frame 602 may include closed strut cells. Diamond shaped strut cells 605 of the outer frame 600 (corresponding to struts 546a-d shown in FIG. 77) may be aligned within the diamond shaped strut cells of the inner frame 602.

[0265] FIG. 92 illustrates a side view of the outer frame 600 protruding from the inner frame 602.

[0266] In examples, the outer frame 600 may be configured to clamp a portion of the heart. The outer frame 600 may, for example, clamp a native heart valve annulus to anchor the prosthetic valve in place. The outer frame 600 may clamp a portion of the heart between a proximal portion 608 and a distal portion 610 of the frame 600 to anchor the frame to the heart. FIG. 93 illustrates an example deployment configuration in which the outer frame 600 clamps the atrial and ventricular sides of the native heart valve to anchor the prosthetic valve 606 in place. In examples, other configurations may be utilized.

[0267] Each feature in the examples of Figures 55A-93 may be used alone or in combination with any other examples disclosed herein.

[0268] Each of the prosthetic valve examples may be utilized in the mitral valve as disclosed herein, or in other deployment locations, such as the native tricuspid valve, or in other deployment locations, although deployment to the aortic or pulmonary valves, as well as other implantation sites, is contemplated.

[0269] Various modifications of each example disclosed herein may be made. Each feature in an example may be modified, substituted, omitted, or combined between examples as desired. Combinations of features between examples may be made as desired. Combinations of features may be made between examples, if desired, to the exclusion of other features in those examples.

[0270] The various examples of seal skirts disclosed herein may have a variety of configurations, including fabric skirts, foam skirts, or braided skirts, as desired. A variety of materials may be utilized, as desired.

[0271] The implants disclosed herein may include prosthetic heart valves or other forms of implants such as stents or filters, among others, diagnostic devices. The implants may be expandable implants configured to transition from a compressed or undeployed state to an expanded or deployed state. The implants may be compressible implants configured to transition to the compressed or undeployed state by compressing inwardly to have a reduced profile.

[0272] Various forms of delivery devices may be utilized with the examples disclosed herein. The delivery devices disclosed herein may be utilized in replacement and also in repair of aortic, mitral, tricuspid, and pulmonary valves. Delivery devices may include delivery devices for delivering other forms of implants, such as stents or filters, among others, or for delivering diagnostic devices, among others.

[0273] The implants and systems disclosed herein may be used in transcatheter mitral or tricuspid valve implantation, and in transaortic valve implantation (TAVI) or replacement of other native heart valves (e.g., pulmonary valves). The delivery devices and systems disclosed herein may be utilized for transarterial access, including transfemoral access, to a patient's heart. The delivery devices and systems may be utilized in transcatheter percutaneous procedures, including transarterial procedures, which may be transfemoral or transcarotid. Transapical procedures, among others, may also be utilized. Other procedures may be utilized as desired.

[0274] Additionally, the methods described herein are not limited to the specifically described methods and may include methods for utilizing the systems and devices disclosed herein. Each step in the method may be modified, removed, or added by the systems, devices, and methods disclosed herein. Each embodiment disclosed herein may, in some embodiments, include a system for implantation within the human body.

[0275] For purposes of this specification, specific aspects, advantages, and novel features of each embodiment of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any manner. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments in various combinations with each other and in various subcombinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature, or combination thereof, nor do they require that the disclosed embodiments have any one or more particular advantages or problems. Features, elements, or combinations of one embodiment can be combined in other embodiments herein. EXAMPLES

[0276] Example 1: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve comprising: one or more prosthetic leaflets; a seal body disposed radially outward of the one or more prosthetic leaflets, the seal body configured to seal against a portion of the native valve; one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve; and one or more magnets configured to attract the seal body and at least one of the one or more anchors to one another.

[0277] Example 2: The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 1, wherein the sealing body includes a frame.

[0278] Example 3: The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 2, wherein the frame includes an outer frame disposed radially outward of the inner frame, the inner frame supporting one or more prosthetic valve leaflets.

[0279] Example 4: The prosthetic valve as described in any embodiment herein, particularly embodiment 3, wherein the outer frame includes a proximal portion coupled to the inner frame and a distal portion, the distal portion including one or more magnets or including one or more ferromagnetic materials configured to be attracted to the one or more magnets.

[0280] Example 5: The prosthetic valve according to any embodiment herein, particularly embodiments 1-4, wherein the sealing body includes a sealing skirt.

[0281] Example 6: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 1-5, wherein the one or more magnets are disposed on the one or more anchors.

[0282] Example 7: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 1-6, wherein the one or more magnets are disposed on the seal body.

[0283] Example 8: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 1-7, further comprising one or more ferromagnetic materials, wherein the one or more magnets are configured to attract the one or more ferromagnetic materials.

[0284] Example 9: An artificial valve as described in any embodiment herein, particularly as described in embodiment 8, wherein one or more ferromagnetic materials are disposed on the seal body and one or more magnets are disposed on the one or more anchors, or one or more ferromagnetic materials are disposed on the one or more anchors and one or more magnets are disposed on the seal body.

[0285] Example 10: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 1-9, wherein the one or more anchors are configured in a hook-like configuration.

[0286] Example 11: A prosthetic valve as described in any embodiment herein, particularly as described in embodiments 1-10, wherein each of the one or more anchors is configured to hook onto a distal tip of a native valve leaflet.

[0287] Example 12: The prosthetic valve as described in any of the embodiments herein, particularly embodiments 1-11, wherein the one or more anchors are configured to be positioned radially outward of the native valve leaflets and the sealing body is configured to be positioned radially inward of the native valve leaflets.

[0288] Example 13: The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 12, wherein the one or more magnets are configured to clamp the native valve leaflets between the seal body and the one or more anchors.

[0289] Example 14: The one or more magnets are a plurality of magnets disposed on the seal body and include a plurality of magnets spaced apart from one another in the circumferential direction, as described in any embodiment herein, particularly as described in embodiments 1 to 13.

[0290] Example 15: The prosthetic valve according to any of the embodiments herein, particularly embodiments 1-14, wherein the prosthetic valve is configured to be deployed relative to a mitral valve or a tricuspid valve.

[0291] Example 16: 1. A method, comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve including one or more prosthetic leaflets; a sealing body disposed radially outward of the one or more prosthetic leaflets, the sealing body configured to seal against a portion of the native valve; one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve; and one or more magnets configured to attract the sealing body and at least one of the one or more anchors to one another.

[0292] Example 17: The method of any embodiment herein, particularly embodiment 16, wherein the seal body comprises a frame.

[0293] Example 18: The method of any embodiment herein, particularly embodiment 17, wherein the frame includes an outer frame disposed radially outward of the inner frame, the inner frame supporting one or more prosthetic valve leaflets.

[0294] Example 19: The method of any embodiment herein, particularly embodiment 18, wherein the outer frame comprises a proximal portion coupled to the inner frame and a distal portion, the distal portion comprising one or more magnets or comprising one or more ferromagnetic materials configured to be attracted to the one or more magnets.

[0295] Example 20: The method as described in any embodiment herein, particularly embodiments 16-19, wherein the seal body includes a seal skirt.

[0296] Example 21: The method of any embodiment herein, particularly embodiments 16-20, wherein the one or more magnets are disposed on the one or more anchors.

[0297] Example 22: The method as described in any embodiment herein, particularly embodiments 16-21, wherein the one or more magnets are disposed on the seal body.

[0298] Example 23: The method of any of the embodiments herein, particularly embodiments 16-22, wherein the one or more magnets are configured to attract one or more ferromagnetic materials.

[0299] Example 24: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve comprising: one or more prosthetic leaflets; and one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, each of the one or more anchors comprising one or more grooves configured to increase flexibility of a respective corresponding anchor.

[0300] Example 25: The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 24, wherein each of the one or more anchors is configured in a hook-like configuration.

[0301] Example 26: A prosthetic valve as described in any embodiment herein, particularly as described in embodiment 24 or 25, wherein each of the one or more anchors is configured to hook onto a distal tip of a native valve leaflet.

[0302] Example 27: 23. The prosthetic valve of any of the embodiments herein, particularly embodiments 24-26, wherein each of the one or more anchors extends radially outward from the valve body supporting one or more prosthetic valve leaflets, each of the one or more anchors including a radially inward facing surface and a radially outward facing surface, and wherein the one or more grooves are disposed on the radially inward facing surface.

[0303] Example 28: The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 27, wherein the one or more grooves are disposed on a radially outward facing surface.

[0304] Example 29: The prosthetic valve as described in any of the embodiments herein, particularly embodiments 24-28, wherein each of the one or more anchors includes an elongate arm having a length, and the one or more grooves extend transversely to the length of the elongate arm.

[0305] Example 30: The prosthetic valve as described in any embodiment herein, particularly embodiment 29, wherein the one or more grooves include a plurality of grooves spaced apart from one another along the length of the elongate arm.

[0306] Example 31: The prosthetic valve as described in any of the embodiments herein, particularly embodiments 24-30, wherein each of the one or more anchors includes a curved portion having a convex curvature, and the one or more grooves are disposed on the curved portion.

[0307] Example 32: An artificial valve as described in any embodiment herein, particularly embodiments 24-31, wherein each of the one or more anchors extends radially outward from the valve body, and the one or more grooves increase the flexibility of each corresponding anchor radially inward.

[0308] Example 33: The prosthetic valve according to any of the embodiments herein, particularly embodiments 24-32, wherein the prosthetic valve is configured to be deployed relative to a mitral valve or a tricuspid valve.

[0309] Example 34: 1. A method comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve comprising one or more prosthetic leaflets and one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, each of the one or more anchors comprising one or more grooves configured to increase flexibility of a respective corresponding anchor.

[0310] Example 35: The method of any embodiment herein, particularly embodiment 34, wherein each of the one or more anchors is configured in a hook-like configuration.

[0311] Example 36: The method of any embodiment herein, particularly embodiment 34 or 35, wherein each of the one or more anchors is configured to hook onto a distal tip of a native valve leaflet.

[0312] Example 37: The method of any of the embodiments herein, particularly embodiments 34-36, wherein each of the one or more anchors extends radially outward from the valve body supporting one or more prosthetic valve leaflets, each of the one or more anchors including a radially inward facing surface and a radially outward facing surface, and the one or more grooves are disposed on the radially inward facing surface.

[0313] Example 38: The method of any embodiment herein, particularly embodiment 37, wherein the one or more grooves are disposed on a radially outward facing surface.

[0314] Example 39: The method of any of the embodiments herein, particularly embodiments 34-38, wherein each of the one or more anchors comprises an elongate arm having a length, and the one or more grooves extend transversely to the length of the elongate arm.

[0315] Example 40: The method of any embodiment herein, particularly embodiment 39, wherein the one or more grooves comprise a plurality of grooves spaced apart from one another along the length of the elongate arm.

[0316] Example 41: The method of any of the embodiments herein, particularly embodiments 34-40, wherein each of the one or more anchors comprises a curved portion having a convex curvature, and the one or more grooves are disposed on the curved portion.

[0317] Example 42: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve comprising: one or more prosthetic leaflets; and one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, each of the one or more anchors comprising a coil.

[0318] Example 43: The prosthetic valve as described in any embodiment herein, particularly embodiment 42, wherein the coil forms a long arm.

[0319] Example 44: The prosthetic valve as described in any embodiment herein, particularly embodiment 42 or 43, wherein the coil comprises a first coil portion and a second coil portion, the first coil portion having a greater stiffness than the second coil portion.

[0320] Example 45: An artificial valve as described in any embodiment herein, particularly embodiment 44, wherein each of the one or more anchors extends radially outward from the valve body supporting one or more artificial valve leaflets, and the second coil portion is disposed radially outward from the first coil portion.

[0321] Example 46: The prosthetic valve as described in any embodiment herein, particularly embodiments 42-45, wherein each of the one or more anchors includes a stiffening arm extending along the coil.

[0322] Example 47: An artificial valve as described in any embodiment herein, particularly embodiment 46, wherein each of the one or more anchors is curved to include an inner diameter and an outer diameter, and the stiffening arms extend along the outer diameter of the coil.

[0323] Example 48: The prosthetic valve as described in any embodiment herein, particularly embodiments 42-47, wherein each of the one or more anchors is configured to form a hook-like configuration.

[0324] Example 49: An artificial valve as described in any embodiment herein, particularly embodiments 42-48, wherein each of the one or more anchors is configured to hook onto the distal tip of a native valve leaflet.

[0325] Example 50: An artificial valve as described in any embodiment herein, particularly embodiments 42-49, wherein each of the one or more anchors includes a curved portion having a convex curvature, and the coil is disposed on the curved portion.

[0326] Example 51: An artificial valve as described in any embodiment herein, particularly embodiments 42-50, wherein each of the one or more anchors extends radially outward from the valve body, and the coil increases the flexibility of each corresponding anchor radially inward.

[0327] Example 52: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 42-51, wherein the coil comprises a spring coil.

[0328] Example 53: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 42-52, wherein the coil comprises an excised hypotube.

[0329] Example 54: 11. An artificial valve as described in any of the embodiments herein, particularly embodiments 42-53, wherein the valve body supports one or more artificial valve leaflets, each of the one or more anchors includes an attachment portion for attachment to the valve body and extends radially outward to a tip portion of the corresponding anchor, and the coil extends radially outward from the attachment portion to the tip portion.

[0330] Example 55: An artificial valve as described in any embodiment herein, particularly embodiments 42-54, wherein each of the one or more anchors comprises an overmold disposed on a corresponding coil.

[0331] Example 56: 10. The prosthetic valve of any of the embodiments herein, particularly embodiments 42-55, wherein the valve body supports one or more prosthetic valve leaflets and has a proximal portion and a distal portion, and wherein one or more anchors extend from the proximal portion of the valve body.

[0332] Example 57: The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 56, further comprising a plurality of hook anchors disposed at a distal portion of the valve body.

[0333] Example 58: The prosthetic valve as described in any embodiment herein, particularly embodiments 42-57, wherein the one or more anchors each include an atrial anchor configured to anchor within an atrium of the heart.

[0334] Example 59: An artificial valve as described in any of the embodiments herein, particularly embodiments 42-58, wherein the valve body supports one or more artificial valve leaflets, and the one or more anchors include a plurality of anchors extending from the valve body and spaced apart from one another in the circumferential direction.

[0335] Example 60: The prosthetic valve as described in any embodiment herein, particularly embodiments 42-59, wherein the one or more anchors support a sealing body for sealing against a native valve.

[0336] Example 61: The prosthetic valve according to any of the embodiments herein, particularly embodiments 42-60, wherein the prosthetic valve is configured to be deployed relative to a mitral valve or a tricuspid valve.

[0337] Example 62: 1. A method comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve comprising one or more prosthetic leaflets and one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, each of the one or more anchors comprising a coil.

[0338] Example 63: The method of any embodiment herein, particularly embodiment 62, wherein the coil forms an elongated arm.

[0339] Example 64: The method of any embodiment herein, particularly embodiment 62 or 63, wherein the coil comprises a first coil portion and a second coil portion, the first coil portion having a greater stiffness than the second coil portion.

[0340] Example 65: The method described in any embodiment herein, particularly embodiment 64, wherein each of the one or more anchors extends radially outward from the valve body supporting one or more prosthetic valve leaflets, and the second coil portion is positioned radially outward from the first coil portion.

[0341] Example 66: The method of any embodiment herein, particularly embodiments 62-65, wherein each of the one or more anchors includes a stiffening arm extending along the coil.

[0342] Example 67: The method described in any embodiment herein, particularly embodiment 66, wherein each of the one or more anchors is curved to include an inner diameter and an outer diameter, and the stiffening arms extend along the outer diameter of the coil.

[0343] Example 68: The method described in any embodiment herein, particularly embodiments 62-67, wherein each of the one or more anchors is configured to form a hook-like configuration.

[0344] Example 69: The method described in any embodiment herein, particularly embodiments 62-68, wherein each of the one or more anchors is configured to hook onto a distal tip of a native valve leaflet.

[0345] Example 70: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve comprising: a valve body enclosing a flow channel extending along a longitudinal dimension; one or more prosthetic valve leaflets extending radially inward from the valve body and disposed within the flow channel; and one or more anchors pivotally coupled to the valve body, the one or more anchors configured to pivot about the longitudinal dimension to vary a radial distance of the one or more anchors from the valve body.

[0346] Example 71: An artificial valve as described in any embodiment herein, particularly embodiment 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.

[0347] Example 72: An artificial valve as described in any embodiment herein, particularly embodiment 70 or 71, wherein each of the one or more anchors is pivotally coupled to the valve body using a hinge.

[0348] Example 73: An artificial valve as described in any embodiment herein, particularly embodiment 72, wherein each of the one or more anchors includes a tip configured to rotate about a corresponding hinge.

[0349] Example 74: An artificial valve as described in any embodiment herein, particularly embodiments 70-73, wherein each of the one or more anchors is configured to pivot about a longitudinal dimension to change the maximum radial extent of the artificial valve.

[0350] Example 75: An artificial valve as described in any embodiment herein, particularly embodiments 70-74, wherein each of the one or more anchors has a length, and the length is configured to remain constant as each corresponding anchor pivots about the longitudinal dimension.

[0351] Example 76: An artificial valve as described in any embodiment herein, particularly embodiments 70-75, wherein each of the one or more anchors is configured to form a hook-like configuration.

[0352] Example 77: An artificial valve as described in any embodiment herein, particularly embodiments 70-76, wherein each of the one or more anchors is configured to hook onto the distal tip of a native valve leaflet.

[0353] Example 78: The prosthetic valve as described in any embodiment herein, particularly embodiments 70-77, wherein each of the one or more anchors includes a distal anchor, and the prosthetic valve further includes a proximal frame support coupled to each corresponding distal anchor, the proximal frame support being configured to pivot about the longitudinal dimension together with the distal anchor.

[0354] Example 79: The prosthetic valve as described in any embodiment herein, particularly embodiments 70-78, wherein the one or more anchors include a plurality of anchors pivotally coupled to the valve body, each anchor being configured to pivot about a longitudinal dimension to vary the radial distance of the plurality of anchors from the valve body.

[0355] Example 80: The prosthetic valve described in any embodiment herein, particularly embodiment 79, wherein the anchors are circumferentially spaced apart from one another around the valve body.

[0356] Example 81: An artificial valve as described in any embodiment herein, particularly embodiments 70-80, wherein 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.

[0357] Example 82: An artificial valve as described in any embodiment herein, particularly embodiments 70 to 81, further comprising one or more locking members configured to lock movement of the one or more anchors around the longitudinal dimension.

[0358] Example 83: The prosthetic valve as described in any of the embodiments herein, particularly embodiments 70-82, wherein the valve body includes an outer surface including a seal body, and the one or more anchors are configured to press the native valve leaflets against the seal body.

[0359] Example 84: The prosthetic valve according to any of the embodiments herein, particularly embodiments 70-83, wherein the prosthetic valve is configured to be deployed relative to a mitral valve or a tricuspid valve.

[0360] Example 85: 1. A method comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve including a valve body enclosing a flow channel extending along a longitudinal dimension, one or more prosthetic leaflets extending radially inward from the valve body and disposed within the flow channel, and one or more anchors pivotally coupled to the valve body, the one or more anchors configured to pivot about the longitudinal dimension to vary a radial distance of the one or more anchors from the valve body.

[0361] Example 86: The method of any embodiment herein, particularly embodiment 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.

[0362] Example 87: The method described in any embodiment herein, particularly embodiment 85 or 86, wherein each of the one or more anchors is pivotally coupled to the valve body using a hinge.

[0363] Example 88: The method described in any embodiment herein, particularly embodiment 87, wherein each of the one or more anchors includes a tip configured to rotate about a corresponding hinge.

[0364] Example 89: The method described in any embodiment herein, particularly embodiments 85-88, wherein each of the one or more anchors is configured to pivot about a longitudinal dimension to change the maximum radial extent of the prosthetic valve.

[0365] Example 90: The method of any embodiment herein, particularly embodiments 85-89, wherein each of the one or more anchors has a length, and the length is configured to remain constant as each corresponding anchor pivots about the longitudinal dimension.

[0366] Example 91: The method described in any embodiment herein, particularly embodiments 85-90, wherein each of the one or more anchors is configured to form a hook-like configuration.

[0367] Example 92: The method described in any embodiment herein, particularly embodiments 85-91, wherein each of the one or more anchors is configured to hook onto a distal tip of a native valve leaflet.

[0368] Example 93: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve comprising: one or more prosthetic leaflets; a seal body disposed radially outward of the one or more prosthetic leaflets, the seal body configured to seal against a portion of the native valve; one or more anchors configured to anchor the one or more prosthetic leaflets relative to the native valve; and a band configured to have an adjustable diameter to move the seal body radially inward or radially outward.

[0369] Example 94: The prosthetic valve as described in any embodiment herein, particularly embodiment 93, further comprising an inner frame disposed radially inward of the seal body.

[0370] Example 95: The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 93 or 94, wherein the sealing body includes a sealing skirt.

[0371] Example 96: An artificial valve as described in any embodiment herein, particularly embodiments 93-95, wherein each of the one or more anchors is configured to hook onto the distal tip of a native valve leaflet.

[0372] Example 97: An artificial valve as described in any embodiment herein, particularly embodiments 93-96, wherein the band includes a loop, the loop having an end and a portion configured to overlap the end.

[0373] Example 98: An artificial valve as described in any embodiment herein, particularly embodiment 97, further comprising a coupler disposed at the end, the portion being configured to slide through the coupler to adjust the diameter of the band.

[0374] Example 99: An artificial valve as described in any embodiment herein, particularly embodiment 98, further comprising an adjustment mechanism disposed at the end, the adjustment mechanism configured to adjust the diameter of the band.

[0375] Example 100: The prosthetic valve as described in any embodiment herein, particularly embodiments 93-99, wherein the band includes a first end portion and a second end portion, and the first end portion is configured to overlap the second end portion.

[0376] Example 101: The prosthetic valve as described in any embodiment herein, particularly embodiment 100, wherein the first end portion is configured to extend along the length of the second end portion.

[0377] Example 102: An artificial valve as described in any embodiment herein, particularly embodiment 100 or 101, wherein the band is configured to have a diameter adjusted by varying the amount that the first end portion overlaps the second end portion.

[0378] Example 103: The prosthetic valve according to any of the embodiments herein, particularly embodiments 93-102, wherein the band is circular.

[0379] Example 104: The prosthetic valve as described in any of the embodiments herein, particularly as described in embodiments 93-103, wherein the band is configured to adjustably adjust its diameter in vivo.

[0380] Example 105: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 93-104, wherein the sealing body is elastic.

[0381] Example 106: The prosthetic valve according to any of the embodiments herein, particularly embodiments 93-105, wherein the band extends circumferentially around the seal body.

[0382] Example 107: The prosthetic valve according to any of the embodiments herein, particularly embodiments 93-106, wherein the prosthetic valve is configured to be deployed relative to a mitral valve or a tricuspid valve.

[0383] Example 108: 1. A method comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve including one or more prosthetic leaflets; a seal body disposed radially outward of the one or more prosthetic leaflets, the seal body configured to seal against a portion of the native valve; one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve; and a band configured to have an adjustable diameter to move the seal body radially inward or radially outward.

[0384] Example 109: The method of any embodiment herein, particularly embodiment 108, wherein the inner frame is disposed radially inward of the seal body.

[0385] Example 110: The method of any embodiment herein, particularly embodiment 108 or 109, wherein the seal body includes a seal skirt.

[0386] Example 111: A method as described in any embodiment herein, particularly embodiments 108-110, wherein each of the one or more anchors is configured to hook onto the distal tip of a native valve leaflet.

[0387] Example 112: The method of any embodiment herein, particularly embodiments 108-111, wherein the band comprises a loop, the loop having an end and a portion configured to overlap the end.

[0388] Example 113: The method of any embodiment herein, particularly embodiment 112, wherein a coupler is disposed at the end and the portion is configured to slide through the coupler to adjust the diameter of the band.

[0389] Example 114: The method of any embodiment herein, particularly embodiment 113, wherein an adjustment mechanism is disposed at the end, the adjustment mechanism being configured to adjust the diameter of the band.

[0390] Example 115: The method of any of the embodiments herein, particularly embodiments 108-114, wherein the band comprises a first end portion and a second end portion, and the first end portion is configured to overlap the second end portion.

[0391] Example 116: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve including: a valve frame surrounding a flow channel; one or more prosthetic leaflets coupled to the valve frame, the one or more prosthetic leaflets extending radially inward from the valve frame and disposed within the flow channel; and a sealing skirt disposed 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 flex to conform to a shape of the native valve.

[0392] Example 117: The prosthetic valve as described in any embodiment herein, particularly embodiment 116, wherein the sealing skirt surrounds the valve frame.

[0393] Example 118: The prosthetic valve as described in any embodiment herein, particularly embodiment 116 or 117, further comprising a proximal tensioning body disposed at a proximal portion of the prosthetic valve and a distal tensioning body disposed at a distal portion of the prosthetic valve, wherein the sealing skirt comprises a proximal end coupled to the proximal tensioning body and a distal end coupled to the distal tensioning body, and the sealing skirt is tensioned by the proximal tensioning body and the distal tensioning body.

[0394] Example 119: An artificial valve as described in any embodiment herein, particularly embodiment 118, wherein the proximal tensioning body includes an arm having a first end connected to a proximal portion of the valve frame and a second end extending radially outward from the first end.

[0395] Example 120: An artificial valve as described in any embodiment herein, particularly embodiment 118 or 119, wherein the distal tensioning body includes 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.

[0396] Example 121: An artificial valve as described in any embodiment herein, particularly embodiments 118-120, further comprising a plurality of proximal tensioning bodies extending radially outward from a proximal portion of the valve frame and a plurality of distal tensioning bodies extending radially outward from a distal portion of the valve frame.

[0397] Example 122: An artificial valve as described in any embodiment herein, particularly embodiment 121, wherein each of the multiple proximal tensioning bodies is circumferentially spaced apart from one another at equal intervals, and each of the multiple distal tensioning bodies is circumferentially spaced apart from one another at equal intervals.

[0398] Example 123: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 118-122, wherein the distal tensioning body comprises a distal anchor for the prosthetic valve.

[0399] Example 124: The prosthetic valve as described in any embodiment herein, particularly embodiments 118-123, wherein the proximal tensioning body comprises a proximal anchor for the prosthetic valve.

[0400] Example 125: The prosthetic valve as described in any embodiment herein, particularly embodiments 118-124, wherein the proximal tensioning body comprises a ring.

[0401] Example 126: The prosthetic valve as described in any embodiment herein, particularly embodiments 118-125, wherein the distal tensioning body comprises a ring.

[0402] Example 127: An artificial valve as described in any embodiment herein, particularly embodiments 116 to 126, further comprising a plurality of wires extending along and supporting the sealing skirt.

[0403] Example 128: An artificial valve as described in any embodiment of the present specification, particularly embodiments 116 to 127, wherein the sealing skirt is elastic and configured to deflect radially inward to conform to the shape of the native valve.

[0404] Example 129: The prosthetic valve is any prosthetic valve as described in any embodiment herein, particularly as described in embodiments 116-128, including a single frame prosthetic valve.

[0405] Example 130: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 116-129, wherein the prosthetic valve is configured to be deployed relative to a mitral valve or a tricuspid valve.

[0406] Example 131: 1. A method comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve including a valve frame surrounding a flow channel, one or more prosthetic leaflets coupled to the valve frame, the one or more prosthetic leaflets extending radially inward from the valve frame and disposed within the flow channel, and a sealing skirt disposed 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 flex to conform to a shape of the native valve.

[0407] Example 132: The method as described in any embodiment herein, particularly embodiment 131, wherein the sealing skirt surrounds the valve frame.

[0408] Example 133: The method of any embodiment herein, particularly embodiment 131 or 132, wherein a proximal tensioning body is disposed at a proximal portion of the artificial valve, a distal tensioning body is disposed at a distal portion of the artificial valve, the sealing skirt includes a proximal end coupled to the proximal tensioning body and a distal end coupled to the distal tensioning body, and the sealing skirt is tensioned by the proximal tensioning body and the distal tensioning body.

[0409] Example 134: The method of any embodiment herein, particularly embodiment 133, wherein the proximal tensioning body includes 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.

[0410] Example 135: The method of any embodiment herein, particularly embodiment 133 or 134, wherein the distal tensioning body includes an arm having a first end coupled to the distal portion of the valve frame and a second end extending radially outward from the first end.

[0411] Example 136: The method of any embodiment herein, particularly embodiments 133-135, 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.

[0412] Example 137: The method described in any embodiment herein, particularly embodiment 136, wherein each of the multiple proximal tensioning bodies is circumferentially spaced apart from one another at equal intervals, and each of the multiple distal tensioning bodies is circumferentially spaced apart from one another at equal intervals.

[0413] Example 138: The method of any embodiment herein, particularly embodiments 133-137, wherein the distal tensioning body comprises a distal anchor for a prosthetic valve.

[0414] Example 139: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve comprising: a valve frame surrounding a flow channel; one or more prosthetic leaflets coupled to the valve frame, the one or more prosthetic leaflets extending radially inward from the valve frame and disposed within the flow channel; a sealing skirt disposed radially outward from the valve frame, the sealing skirt including a pocket; and a ring disposed in the pocket, the ring configured to support the sealing skirt.

[0415] Example 140: The prosthetic valve as described in any embodiment herein, particularly embodiment 139, wherein the pocket comprises overlapping material relative to the sealing skirt.

[0416] Example 141: The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 139 or 140, wherein the sealing skirt includes a proximal portion and a distal portion, and the pocket is disposed in the proximal portion.

[0417] Example 142: An artificial valve as described in any embodiment herein, particularly embodiment 141, further comprising one or more distal anchors, wherein the distal portion of the sealing skirt is attached to the one or more distal anchors.

[0418] Example 143: An artificial valve as described in any embodiment herein, particularly embodiment 142, wherein each of the one or more distal anchors is configured to hook onto a distal tip of a native valve leaflet.

[0419] Example 144: A prosthetic valve as described in any embodiment herein, particularly as described in embodiment 142 or 143, wherein the distal portion of the sealing skirt is configured to slide along the one or more distal anchors.

[0420] Example 145: The prosthetic valve as described in any embodiment herein, particularly embodiments 139-144, wherein the ring includes a proximal tensioning body configured to apply tension to the sealing skirt.

[0421] Example 146: An artificial valve as described in any embodiment herein, particularly embodiments 139-145, wherein the sealing skirt is in tension and configured to flex to conform to the shape of the native valve.

[0422] Example 147: The prosthetic valve is any prosthetic valve as described in any embodiment herein, particularly as described in embodiments 139-146, including a single-frame prosthetic valve.

[0423] Example 148: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 139-147, wherein the prosthetic valve is configured to be deployed relative to a mitral valve or a tricuspid valve.

[0424] Example 149: 1. A method, comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve including: a valve frame surrounding a flow channel; one or more prosthetic leaflets coupled to the valve frame, the one or more prosthetic leaflets extending radially inward from the valve frame and disposed within the flow channel; a sealing skirt disposed radially outward from the valve frame, the sealing skirt including a pocket; and a ring disposed in the pocket, the ring configured to support the sealing skirt.

[0425] Example 150: The method of any embodiment herein, particularly embodiment 149, wherein the pocket comprises overlapping material relative to the seal skirt.

[0426] Example 151: The method of any embodiment herein, particularly embodiment 149 or 150, wherein the sealing skirt comprises a proximal portion and a distal portion, and the pocket is disposed in the proximal portion.

[0427] Example 152: The method of any embodiment herein, particularly embodiment 151, wherein the distal portion of the seal skirt is attached to one or more distal anchors.

[0428] Example 153: The method described in any embodiment herein, particularly embodiment 152, wherein each of the one or more distal anchors is configured to hook onto a distal tip of a native valve leaflet.

[0429] Example 154: The method of any embodiment herein, particularly embodiment 152 or 153, wherein the distal portion of the sealing skirt is configured to slide along the one or more distal anchors.

[0430] Example 155: The method of any of the embodiments herein, particularly embodiments 149-154, wherein the ring includes a proximal tensioning body configured to apply tension to the seal skirt.

[0431] Example 156: The method of any of the embodiments herein, particularly embodiments 149-155, wherein the sealing skirt is in tension and configured to flex to conform to the shape of the native valve.

[0432] Example 157: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve comprising: a valve frame surrounding a flow channel; one or more prosthetic leaflets coupled to the valve frame, the one or more prosthetic leaflets extending radially inward from the valve frame and disposed within the flow channel; one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve; a sealing skirt disposed radially outward from the valve frame, the sealing skirt including a distal portion; and one or more slidable couplers coupling a distal portion of the sealing skirt to the one or more anchors, the one or more slidable couplers configured to allow the distal portion of the sealing skirt to slide relative to the one or more anchors.

[0433] Example 158: An artificial valve as described in any embodiment herein, particularly embodiment 157, wherein each of the one or more slidable couplers includes a ring.

[0434] Example 159: An artificial valve as described in any embodiment herein, particularly embodiment 158, wherein the ring surrounds a corresponding one of the one or more anchors and is configured to slide along the one or more anchors.

[0435] Example 160: An artificial valve as described in any embodiment herein, particularly embodiments 157-159, wherein each of the one or more anchors includes an elongate arm, and the one or more slidable couplers are configured to slide along the elongate arm to enable a distal portion of the sealing skirt to slide relative to the one or more anchors.

[0436] Example 161: An artificial valve as described in any embodiment herein, particularly embodiment 160, wherein the long arm includes a tip and one or more slidable couplers are configured to slide away from the tip.

[0437] Example 162: An artificial valve as described in any embodiment herein, particularly embodiment 161, wherein the long arm includes a protruding portion disposed between one or more slidable couplers and the tip, the protruding portion being configured to overlap the distal tip of the natural valve leaflet.

[0438] Example 163: An artificial valve as described in any embodiment herein, particularly embodiment 162, wherein one or more slidable couplers are configured to slide away from the tip to increase the size of the protruding portion.

[0439] Example 164: An artificial valve as described in any embodiment herein, particularly embodiments 157-163, wherein the sealing skirt is in tension and configured to flex to conform to the shape of the native valve.

[0440] Example 165: The prosthetic valve is any prosthetic valve as described in any embodiment herein, particularly as described in embodiments 157-164, including a single-frame prosthetic valve.

[0441] Example 166: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 157-165, wherein the prosthetic valve is configured to be deployed relative to a mitral valve or a tricuspid valve.

[0442] Example 167: 11. The method, comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve including: a valve frame surrounding a flow channel; one or more prosthetic leaflets coupled to the valve frame, the one or more prosthetic leaflets extending radially inward from the valve frame and disposed within the flow channel; one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve; a sealing skirt disposed radially outward from the valve frame, the sealing skirt including a distal portion; and one or more slidable couplers coupling a distal portion of the sealing skirt to the one or more anchors, the one or more slidable couplers configured to allow the distal portion of the sealing skirt to slide relative to the one or more anchors.

[0443] Example 168: The method described in any embodiment herein, particularly embodiment 167, wherein each of the one or more slidable couplers includes a ring.

[0444] Example 169: The method described in any embodiment herein, particularly embodiment 168, wherein the ring surrounds a corresponding one of the one or more anchors and is configured to slide along the one or more anchors.

[0445] Example 170: A method as described in any embodiment herein, particularly embodiments 167-169, wherein each of the one or more anchors includes an elongate arm, and the one or more slidable couplers are configured to slide along the elongate arm to enable a distal portion of the sealing skirt to slide relative to the one or more anchors.

[0446] Example 171: The method of any embodiment herein, particularly embodiment 170, wherein the long arm includes a tip and the one or more slidable couplers are configured to slide away from the tip.

[0447] Example 172: A method as described in any embodiment herein, particularly embodiment 171, wherein the long arm includes a protruding portion disposed between one or more slidable couplers and the tip, the protruding portion being configured to overlap the distal tip of the native valve leaflet.

[0448] Example 173: The method of any embodiment herein, particularly embodiment 172, wherein the one or more slidable couplers are configured to slide away from the tip to increase the size of the protruding portion.

[0449] Example 174: The method of any of the embodiments herein, particularly embodiments 167-173, wherein the sealing skirt is in tension and configured to flex to conform to the shape of the native valve.

[0450] Example 175: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve comprising: one or more prosthetic leaflets; and one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, each anchor comprising a T-bar.

[0451] Example 176: The prosthetic valve as described in any embodiment herein, particularly embodiment 175, wherein each of the one or more anchors includes an atrial anchor.

[0452] Example 177: An artificial valve as described in any embodiment herein, particularly embodiment 175 or 176, wherein the valve frame supports one or more artificial 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.

[0453] Example 178: An artificial valve as described in any embodiment herein, particularly embodiment 177, wherein each T-bar includes a stem connected to a proximal portion of the valve frame and a crossbar extending laterally relative to the stem.

[0454] Example 179: An artificial valve as described in any embodiment herein, particularly embodiment 178, wherein each of the T-bars is configured such that the crossbar is positioned radially outward from the stem.

[0455] Example 180: The one or more anchors include multiple anchors, and the crossbars of the multiple anchors form a ring extending circumferentially around the prosthetic valve, as described in any embodiment herein, particularly embodiment 178 or 179.

[0456] Example 181: An artificial valve as described in any embodiment herein, particularly embodiments 178-180, wherein the one or more anchors include multiple anchors, and the crossbars of the multiple anchors form a segmented flange extending circumferentially around the artificial valve.

[0457] Example 182: The prosthetic valve as described in any embodiment herein, particularly embodiments 178-181, wherein the stem includes undulations configured to provide flexibility to the stem.

[0458] Example 183: An artificial valve as described in any embodiment herein, particularly embodiments 178-182, wherein the crossbar includes a central portion connected to the stem 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 flex radially inward toward the stem.

[0459] Example 184: An artificial valve as described in any embodiment herein, particularly embodiments 175-183, wherein each of the one or more anchors includes a proximal anchor, and the artificial valve further includes one or more distal anchors, each of the one or more distal anchors configured to hook onto a distal tip of a native valve leaflet.

[0460] Example 185: An artificial valve as described in any embodiment herein, particularly as described in embodiment 184, wherein one or more distal anchors are circumferentially disposed between two proximal anchors.

[0461] Example 186: An artificial valve as described in any embodiment herein, particularly embodiments 175-185, further comprising a sealing skirt having a proximal portion and a distal portion, wherein the one or more anchors comprise a proximal tensioning body coupled to the proximal portion of the sealing skirt, the proximal tensioning body configured to apply tension to the sealing skirt.

[0462] Example 187: An artificial valve as described in any embodiment herein, particularly embodiment 186, wherein each of the one or more anchors includes a proximal anchor, and the artificial valve further includes one or more distal anchors, and each of the one or more distal anchors includes a distal tensioning body coupled to a distal portion of the sealing skirt, and the distal tensioning body is configured to apply tension to the sealing skirt.

[0463] Example 188: The prosthetic valve is any of the prosthetic valves described herein, including single-frame prosthetic valves, particularly those described in Examples 175-187.

[0464] Example 189: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 175-188, wherein the prosthetic valve is configured to be deployed relative to a mitral valve or a tricuspid valve.

[0465] Example 190: 1. A method comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve comprising one or more prosthetic leaflets and one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, each anchor comprising a T-bar.

[0466] Example 191: The method of any embodiment herein, particularly embodiment 190, wherein each of the one or more anchors includes an atrial anchor.

[0467] Example 192: A method as described in any embodiment herein, particularly embodiment 190 or 191, wherein the valve frame supports one or more artificial 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.

[0468] Example 193: The method described in any embodiment herein, particularly embodiment 192, wherein each T-bar includes a stem connected to a proximal portion of the valve frame and a crossbar extending laterally relative to the stem.

[0469] Example 194: The method of any embodiment herein, particularly embodiment 193, wherein each of the T-bars is configured such that the crossbar is positioned radially outward from the stem.

[0470] Example 195: The method of any embodiment herein, particularly embodiment 193 or 194, wherein the one or more anchors include multiple anchors, and the crossbars of the multiple anchors form a ring extending circumferentially around the prosthetic valve.

[0471] Example 196: The method described in any embodiment herein, particularly embodiments 193-195, wherein the one or more anchors include multiple anchors, and crossbars of the multiple anchors form a segmented flange extending circumferentially around the prosthetic valve.

[0472] Example 197: The method of any embodiment herein, particularly embodiments 193-196, wherein the stem includes undulations configured to provide flexibility to the stem.

[0473] Example 198: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve comprising: one or more prosthetic leaflets; a valve body supporting the one or more prosthetic leaflets; a plurality of distal anchors, each including a long arm having a first end coupled to the valve body and extending radially outward along a length from the first end to a tip of a corresponding long arm, each long arm configured to hook onto a distal tip of a native leaflet to anchor the one or more prosthetic leaflets to the native valve; and a sealing skirt forming a disk extending along the length of each long arm and extending circumferentially between adjacent long arms.

[0474] Example 199: A prosthetic valve as described in any embodiment herein, particularly embodiment 198, wherein the sealing skirt is coaxially positioned relative to each of the elongate arms.

[0475] Example 200: The prosthetic valve as described in any embodiment herein, particularly embodiment 198 or 199, wherein a sealing skirt extends from the first end to a distal end of each elongate arm.

[0476] Example 201: The prosthetic valve according to any of the embodiments herein, particularly embodiments 198-200, wherein the valve body includes a frame supporting one or more prosthetic valve leaflets.

[0477] Example 202: The prosthetic valve as described in any embodiment herein, particularly embodiment 201, wherein the sealing skirt is positioned coaxially relative to the frame.

[0478] Example 203: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 198-202, wherein the disc has a convex curvature.

[0479] Example 204: An artificial valve as described in any embodiment herein, particularly embodiments 198-203, wherein each of the long arms includes a curved portion and the disk is configured to extend along the curved portion.

[0480] Example 205: An artificial valve as described in any embodiment herein, particularly embodiments 198 to 204, wherein at least a portion of the disk is configured to be positioned radially outward of the native valve leaflets.

[0481] Example 206: The prosthetic valve is any prosthetic valve as described in any embodiment herein, particularly as described in embodiments 198-205, including a single frame prosthetic valve.

[0482] Example 207: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 198-206, wherein the prosthetic valve is configured to be deployed relative to a mitral valve or a tricuspid valve.

[0483] Example 208: 1. A method comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve comprising: one or more prosthetic leaflets, a valve body supporting the one or more prosthetic leaflets; a plurality of distal anchors, each comprising a long arm having a first end coupled to the valve body and extending radially outward along a length from the first end to a tip of a corresponding long arm, each long arm configured to hook onto a distal tip of a native leaflet to anchor the one or more prosthetic leaflets to the native valve; and a sealing skirt forming a disk extending along the length of each long arm and extending circumferentially between adjacent long arms.

[0484] Example 209: The method as described in any embodiment herein, particularly embodiment 208, wherein the sealing skirt is positioned coaxially with respect to each of the elongate arms.

[0485] Example 210: The method of any embodiment herein, particularly embodiment 208 or 209, wherein a sealing skirt extends from the first end to a distal end of each elongate arm.

[0486] Example 211: The method of any of the embodiments herein, particularly embodiments 208-210, wherein the valve body includes a frame supporting one or more prosthetic valve leaflets.

[0487] Example 212: The method of any embodiment herein, particularly embodiment 211, wherein the sealing skirt is positioned coaxially relative to the frame.

[0488] Example 213: The method as described in any embodiment herein, particularly embodiments 208-212, wherein the disc has a convex curvature.

[0489] Example 214: The method of any of the embodiments herein, particularly embodiments 208-213, wherein each of the long arms includes a curved portion and the disk is configured to extend along the curved portion.

[0490] Example 215: The method of any of the embodiments herein, particularly embodiments 208-214, wherein at least a portion of the disk is configured to be positioned radially outward of the native valve leaflets.

[0491] Example 216: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve including one or more prosthetic leaflets and one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, each of the one or more anchors including a hinge configured to allow a respective corresponding anchor to flex radially.

[0492] Example 217: An artificial valve as described in any embodiment herein, particularly embodiment 216, wherein the hinges are configured to allow each corresponding anchor to flex radially inward.

[0493] Example 218: The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 216 or 217, wherein the hinge comprises a mechanical bearing hinge or a living hinge.

[0494] Example 219: An artificial valve as described in any embodiment herein, particularly embodiments 216-218, wherein the hinges are configured to prevent each corresponding anchor from bending radially outward.

[0495] Example 220: An artificial valve as described in any embodiment herein, particularly embodiments 216-219, wherein each of the one or more anchors is configured to form a hook-like configuration.

[0496] Example 221: An artificial valve as described in any embodiment herein, particularly embodiments 216-220, wherein each of the one or more anchors includes a first portion and a second portion coupled to the first portion, the first portion extending distally and having a convex curvature in the distal direction, and the second portion extending linearly proximally to a tip of the corresponding anchor.

[0497] Example 222: The prosthetic valve as described in any embodiment herein, particularly embodiment 221, wherein the hinge is located on the second part or at the junction of the first part and the second part.

[0498] Example 223: The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 221, wherein the hinge is disposed on the first portion.

[0499] Example 224: An artificial valve as described in any embodiment herein, particularly embodiments 216-223, wherein each of the one or more anchors extends radially outward from the valve body supporting one or more artificial valve leaflets.

[0500] Example 225: An artificial valve as described in any embodiment herein, particularly embodiment 224, wherein the valve body includes a proximal end portion and a distal end portion, and each of the one or more anchors is coupled to the distal end portion of the valve body.

[0501] Example 226: The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 224 or 225, wherein the valve body includes an inner valve body and a seal body arranged radially outside the inner valve body.

[0502] Example 227: The prosthetic valve as described in any embodiment herein, particularly embodiment 226, wherein the inner valve body comprises an inner frame and the seal body comprises an outer frame.

[0503] Example 228: The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 226 or 227, wherein the sealing body includes an outer frame and a sealing skirt disposed on the outer frame.

[0504] Example 229: The prosthetic valve as described in any embodiment herein, particularly embodiments 226-228, wherein each of the one or more anchors comprises a long arm.

[0505] Example 230: The prosthetic valve as described in any embodiment herein, particularly embodiments 226-229, wherein the inner valve body includes a distal end portion and a proximal end portion, the seal body includes a distal end portion and a proximal end portion, and the proximal end portion of the inner valve body is bonded to the proximal end portion of the seal body.

[0506] Example 231: An artificial valve as described in any embodiment herein, particularly embodiment 230, wherein the distal end portion of the inner valve body is spaced apart from the distal end portion of the seal body with a gap.

[0507] Example 232: An artificial valve as described in any embodiment herein, particularly embodiments 216-231, wherein the hinges are configured to enable each corresponding anchor to flex radially inward in response to a radially inward force of the native valve leaflets.

[0508] Example 233: An artificial valve as described in any embodiment herein, particularly embodiments 216-232, wherein the hinges are configured to allow each corresponding anchor to flex radially inward in response to systolic movement of the native valve leaflets.

[0509] Example 234: An artificial valve as described in any embodiment herein, particularly embodiments 216 to 233, wherein each of the one or more anchors is configured to extend onto the distal tip of the native valve leaflet and thereby anchor to a corresponding native valve leaflet.

[0510] Example 235: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 216-234, wherein the prosthetic valve is configured to be deployed relative to a mitral valve or a tricuspid valve.

[0511] Example 236: 1. A method comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve comprising one or more prosthetic leaflets and one or more anchors configured to anchor the one or more prosthetic leaflets to the native valve, each of the one or more anchors comprising a hinge configured to allow a respective anchor to flex radially.

[0512] Example 237: The method of any embodiment herein, particularly embodiment 236, wherein the hinges are configured to allow each corresponding anchor to flex radially inward.

[0513] Example 238: The method as described in any embodiment herein, particularly embodiment 236 or 237, wherein the hinge comprises a mechanical bearing hinge or a living hinge.

[0514] Example 239: The method of any of the embodiments herein, particularly embodiments 236-238, wherein the hinges are configured to prevent each corresponding anchor from bending radially outward.

[0515] Example 240: The method described in any embodiment herein, particularly embodiments 236-239, wherein each of the one or more anchors is configured to form a hook-like configuration.

[0516] Example 241: The method of any of the embodiments herein, particularly embodiments 236-240, wherein each of the one or more anchors includes a first portion and a second portion coupled to the first portion, the first portion extending distally and having a convex curvature in the distal direction, and the second portion extending linearly proximally to a tip of the corresponding anchor.

[0517] Example 242: The method of any embodiment herein, particularly embodiment 241, wherein the hinge is located on the second portion or at the junction of the first portion and the second portion.

[0518] Example 243: The method of any embodiment herein, particularly embodiment 241, wherein the hinge is disposed on the first portion.

[0519] Example 244: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve comprising: an inner frame supporting one or more prosthetic leaflets; an outer frame disposed radially outward from the inner frame and surrounding the inner frame, the outer frame being disposed spaced apart from the inner frame with a gap; and one or more anchors coupled to the outer frame, each anchor configured to be disposed radially outward from one or more leaflets of the native valve, thereby anchoring the prosthetic valve to the native valve.

[0520] Example 245: An artificial valve as described in any embodiment herein, particularly embodiment 244, wherein each of the one or more anchors is configured to form a hook-like configuration.

[0521] Example 246: An artificial valve as described in any embodiment herein, particularly embodiment 244 or 245, wherein each of the one or more anchors includes a connecting portion and a tip portion, the connecting portion being connected to the outer frame and the tip portion being configured to extend proximally from the connecting portion.

[0522] Example 247: The prosthetic valve as described in any embodiment herein, particularly embodiment 246, wherein the connecting portion has a convex curvature in the distal direction.

[0523] Example 248: The prosthetic valve as described in any embodiment herein, particularly as described in embodiment 246 or 247, wherein the distal end portion is straight.

[0524] Example 249: The artificial valve as described in any embodiment herein, particularly embodiments 246-248, wherein the outer frame includes a distal end portion and the connecting portion is connected to the distal end portion of the outer frame.

[0525] Example 250: An artificial valve as described in any embodiment herein, particularly embodiments 246-249, wherein the outer frame includes a plurality of struts forming a plurality of distal apices, and the connecting portions are connected to corresponding ones of the distal apices.

[0526] Example 251: An artificial valve as described in any embodiment herein, particularly embodiments 246-250, wherein the outer frame includes a plurality of struts forming a lattice structure having a plurality of openings, and the tip portions are configured to be aligned with corresponding ones of the plurality of openings.

[0527] Example 252: The prosthetic valve as described in any embodiment herein, particularly embodiments 244-251, wherein the inner frame includes a proximal end portion and a distal end portion, and the outer frame includes a proximal end portion and a distal end portion, and the proximal end portion of the inner frame is bonded to the proximal end portion of the outer frame.

[0528] Example 253: An artificial valve as described in any embodiment herein, particularly embodiment 252, wherein the distal end portion of the inner frame is separated from the distal end portion of the outer frame by a gap.

[0529] Example 254: The prosthetic valve as described in any embodiment herein, particularly embodiments 244-253, wherein the one or more anchors are configured to clamp the leaflets of the native valve between the one or more anchors and a portion of the prosthetic valve.

[0530] Example 255: An artificial valve as described in any embodiment herein, particularly embodiment 254, wherein the one or more anchors are configured to clamp the leaflets of the native valve between the one or more anchors and the outer frame.

[0531] Example 256: An artificial valve as described in any embodiment herein, particularly embodiments 244-255, wherein the inner frame has a radial thickness and the outer frame has a radial thickness that is thinner than the radial thickness of the inner frame.

[0532] Example 257: An artificial valve as described in any embodiment herein, particularly embodiments 244-256, wherein the inner frame has a radial thickness, and each of the one or more anchors has a radial thickness that is less than the radial thickness of the inner frame.

[0533] Example 258: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 244-257, further comprising a sealing skirt disposed on the outer frame.

[0534] Example 259: An artificial valve as described in any embodiment herein, particularly embodiments 244-258, wherein each of the one or more anchors is configured to be actuated to change the radial position of the corresponding anchor.

[0535] Example 260: An artificial valve as described in any embodiment herein, particularly embodiment 259, wherein each of the one or more anchors includes a tip portion configured to extend proximally when the artificial valve is in a crimped 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.

[0536] Example 261: An artificial valve as described in any embodiment herein, particularly embodiment 259 or 260, wherein the outer frame includes a distal end portion having one or more actuator couplers for coupling to an actuator assembly, the one or more actuator couplers being configured to be pulled radially inward by the actuator assembly to deflect one or more anchors radially outward.

[0537] Example 262: An artificial valve as described in any embodiment herein, particularly embodiment 261, wherein the one or more actuator couplers include one or more eyelets configured to be coupled to one or more tethers of the actuator assembly.

[0538] Example 263: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 244-262, wherein the prosthetic valve is configured to be deployed relative to a mitral valve or a tricuspid valve.

[0539] Example 264: 1. A method, comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve including one or more prosthetic leaflets, an inner frame supporting the one or more prosthetic leaflets, an outer frame disposed radially outward from the inner frame and surrounding the inner frame, the outer frame disposed at a gap from the inner frame, and one or more anchors coupled to the outer frame, each anchor configured to be disposed radially outward from one or more leaflets of the native valve to anchor to the native valve.

[0540] Example 265: The method described in any embodiment herein, particularly embodiment 264, wherein each of the one or more anchors is configured to form a hook-like configuration.

[0541] Example 266: The method described in any embodiment herein, particularly embodiment 264 or 265, wherein each of the one or more anchors includes a connecting portion and a tip portion, the connecting portion being connected to the outer frame and the tip portion being configured to extend proximally from the connecting portion.

[0542] Example 267: The method of any embodiment herein, particularly embodiment 266, wherein the binding portion has a convex curvature in the distal direction.

[0543] Example 268: The method of any of the embodiments herein, particularly embodiment 266 or 267, wherein the tip portion is straight.

[0544] Example 269: The method of any embodiment herein, particularly embodiments 266-268, wherein the outer frame includes a distal end portion and the connecting portion is connected to the distal end portion of the outer frame.

[0545] Example 270: The method of any of the embodiments herein, particularly embodiments 266-269, wherein the outer frame includes a plurality of struts forming a plurality of distal apices, and the connecting portions are connected to corresponding ones of the distal apices.

[0546] Example 271: The method of any of the embodiments herein, particularly embodiments 266-270, wherein the outer frame includes a plurality of struts forming a lattice structure having a plurality of openings, and the tip portions are configured to be aligned with corresponding ones of the plurality of openings.

[0547] Example 272: 1. A prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve comprising: one or more prosthetic leaflets; and a frame including 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 to the inner frame, the outer frame being biased radially outward from the inner frame and including a plurality of struts surrounding a plurality of openings, the inner frame being configured to support one or more prosthetic leaflets and including a plurality of struts surrounding 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 alternatively, at least a portion of the outer frame being aligned within at least one of the plurality of openings of the inner frame.

[0548] Example 273: An artificial valve as described in any embodiment herein, particularly embodiment 272, wherein the frame is configured to expand radially outward from a crimped configuration to an expanded configuration, and each of the inner frame and the outer frame has a cylindrical shape in the crimped configuration, and the outer frame has an hourglass shape in the expanded configuration.

[0549] Example 274: The prosthetic valve as described in any embodiment herein, in particular embodiment 273, wherein the inner frame has a cylindrical shape in the expanded configuration.

[0550] Example 275: An artificial valve as described in any embodiment herein, particularly embodiment 273 or 274, wherein at least a portion of the inner frame is configured to be positioned within at least one of the multiple openings in the outer frame when the frame is in a crimped configuration.

[0551] Example 276: An artificial valve as described in any embodiment herein, particularly embodiments 273-275, wherein at least a portion of the outer frame is configured to be positioned within at least one of the multiple openings in the inner frame when the frame is in a crimped configuration.

[0552] Example 277: An artificial valve as described in any embodiment herein, particularly embodiments 272-276, wherein a plurality of struts of the outer frame form a plurality of occluded strut cells, and at least a portion of the inner frame is aligned within at least one of the plurality of occluded strut cells.

[0553] Example 278: An artificial valve as described in any embodiment herein, particularly embodiments 272-277, wherein the struts of the outer frame form a plurality of open strut cells, and at least a portion of the inner frame is aligned within at least one of the plurality of open strut cells.

[0554] Example 279: An artificial valve as described in any embodiment of the present specification, particularly embodiments 272 to 278, wherein the multiple struts of the outer frame form multiple strut cells, each having a diamond shape.

[0555] Example 280: An artificial valve as described in any embodiment of the present specification, particularly embodiments 272 to 279, wherein the multiple struts of the inner frame form multiple strut cells, each having a diamond shape.

[0556] Example 281: An artificial valve as described in any embodiment herein, particularly embodiments 272-280, wherein the struts of the outer frame form diamond-shaped strut cells and the struts of the inner frame form diamond-shaped strut cells that are aligned within the diamond-shaped strut cells of the outer frame.

[0557] Example 282: An artificial valve as described in any embodiment herein, particularly embodiments 272-281, wherein the struts of the inner frame form diamond-shaped strut cells and the struts of the outer frame form diamond-shaped strut cells that are aligned within the diamond-shaped strut cells of the inner frame.

[0558] Example 283: An artificial valve as described in any embodiment of the present specification, particularly embodiments 272 to 282, wherein the multiple struts of the inner frame form at least three diamond-shaped strut cells each spaced apart from each other in the circumferential direction.

[0559] Example 284: The prosthetic valve as described in any embodiment herein, particularly embodiments 272-283, wherein the outer frame includes a proximal portion, a distal portion, and a central portion, the proximal portion being configured to extend radially outward from the central portion, and the distal portion being configured to extend radially outward from the central portion.

[0560] Example 285: An artificial valve as described in any embodiment herein, particularly embodiment 284, wherein the outer frame is configured to anchor the frame to the heart by clamping a portion of the heart between the proximal portion and the distal portion.

[0561] Example 286: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 272-285, wherein the outer frame is configured to anchor the frame to the native valve.

[0562] Example 287: An artificial valve as described in any embodiment herein, particularly embodiments 272-286, further comprising one or more anchors coupled to the outer frame, the one or more anchors configured to form hooks for anchoring to the native valve.

[0563] Example 288: An artificial valve as described in any embodiment herein, particularly embodiments 272-287, further comprising one or more anchors coupled to the inner frame, the one or more anchors configured to form hooks for anchoring to the native valve.

[0564] Example 289: An artificial valve as described in any embodiment herein, particularly embodiments 272-288, further comprising one or more anchors coupled to the outer frame or to the inner frame, the one or more anchors being configured to form hooks for clamping leaflets of a native valve.

[0565] Example 290: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 272-289, further comprising a sealing skirt disposed on the outer frame.

[0566] Example 291: The prosthetic valve as described in any embodiment herein, particularly as described in embodiments 272-290, wherein the prosthetic valve is configured to be deployed relative to a mitral valve or a tricuspid valve.

[0567] Example 292: 1. A method comprising: deploying a prosthetic valve relative to a native valve, the prosthetic valve comprising one or more prosthetic 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 to the inner frame, the outer frame being biased radially outward from the inner frame and comprising a plurality of struts circumscribing a plurality of openings, the inner frame being configured to support one or more prosthetic leaflets and comprising a plurality of struts circumscribing 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 alternatively, at least a portion of the outer frame being aligned within at least one of the plurality of openings of the inner frame.

[0568] Example 293: The method of any embodiment herein, particularly embodiment 292, wherein the frame is configured to expand radially outward from a crimped configuration to an expanded configuration, and each of the inner frame and the outer frame has a cylindrical shape in the crimped configuration and the outer frame has an hourglass shape in the expanded configuration.

[0569] Example 294: The method as described in any embodiment herein, particularly embodiment 293, wherein the inner frame has a cylindrical shape in the expanded configuration.

[0570] Example 295: The method of any embodiment herein, particularly embodiment 293 or 294, wherein at least a portion of the inner frame is configured to be positioned within at least one of the multiple openings in the outer frame when the frames are in a crimped configuration.

[0571] Example 296: The method of any embodiment herein, particularly embodiments 293-295, wherein at least a portion of the outer frame is configured to be disposed within at least one of the multiple openings of the inner frame when the frames are in a crimped configuration.

[0572] Example 297: The method described in any embodiment herein, particularly embodiments 292-296, wherein the struts of the outer frame form a plurality of blocked strut cells, and at least a portion of the inner frame is aligned within at least one of the plurality of blocked strut cells.

[0573] Example 298: The method described in any embodiment herein, particularly embodiments 292-297, wherein the struts of the outer frame form a plurality of open strut cells, and at least a portion of the inner frame is aligned within at least one of the plurality of open strut cells.

[0574] Example 299: The method of any embodiment herein, particularly embodiments 292-298, wherein the struts of the outer frame form a plurality of strut cells, each of the struts having a diamond shape.

[0575] Example 300: The method of any of the embodiments herein, particularly embodiments 292-299, wherein the prosthetic valve is configured to be deployed relative to a mitral valve or a tricuspid valve.

[0576] Any feature in any of the above-mentioned embodiments, including but not limited to any of the above-mentioned embodiments 1-300, is applicable to all other aspects and embodiments identified herein, including but not limited to any of the above-mentioned embodiments 1-300. Moreover, any feature in any of the above-mentioned embodiments, including but not limited to any of the above-mentioned embodiments 1-300, can be combined independently in any manner with other embodiments described herein, either in part or in whole, for example, one, two, three, or more of the embodiments can be combined in whole or in part. Furthermore, any feature in any of the above-mentioned embodiments, including but not limited to any of the above-mentioned embodiments 1-300, can be made optional with other embodiments. Any of the above-mentioned embodiments relating to a method can be performed by a system or device constituting another embodiment, and any of the above-mentioned embodiments relating to a system or device can be configured to perform a method constituting another embodiment or another embodiment, including but not limited to any of the above-mentioned embodiments 1-300.

[0577] Finally, although each aspect of the present specification is emphasized by referring to specific examples, it is understood that those skilled in the art will readily understand that each of these disclosed examples is merely for illustrating the principles of the subject matter disclosed herein. Therefore, it is understood that the disclosed subject matter is not limited in any way by the specific methodology, protocols, and / or reagents, etc., as described herein. Thus, various modifications or variations or alternative configurations of the disclosed subject matter can be made in accordance with the teachings of the present specification without departing from the spirit of the present specification. Finally, the terms used in the present specification are merely 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 defined only by the claims. Thus, the systems, devices, and methods are not strictly limited to those shown and described.

[0578] Specific examples of the systems, devices, and methods are described herein, including the best modes known to the inventors for carrying out the same. Of course, variations on these described examples will become apparent to those skilled in the art upon reading the above description. The inventors anticipate that such variations will be adopted by those skilled in the art as appropriate, and the inventors intend for the systems, devices, and methods to be practiced differently than specifically described herein. Accordingly, the systems, devices, and methods include all modifications and equivalents of the subject matter recited in the appended claims as permitted by applicable law. Moreover, unless otherwise indicated herein and unless otherwise clearly contradicted by context, combinations of the above-described examples in all possible variations thereof are encompassed by the systems, devices, and methods.

[0579] Grouping of alternative examples, components, or steps of systems, apparatus, and methods is not to be construed as limiting. Each group member may be referenced and claimed individually or in any combination with other group members disclosed herein. It is contemplated that one or more members of a group may be included within, and deleted from, a group for reasons of convenience and / or patentability. When such inclusion or deletion is made, the specification is deemed to include the modified group and thus fulfills the description of all Markush group references used in the appended claims.

[0580] Unless otherwise indicated, all numbers expressing properties, items, quantities, parameters, characteristics, terms, and the like, used in the specification and claims are to be understood in all instances as being modified by the term "about." As used herein, the term "about" is meant to encompass approximations that may vary in the property, item, quantity, parameter, characteristic, or term so qualified, but which may still perform the desired operation or process described herein.

[0581] As used in the context of describing the systems, devices, and methods (particularly in the context of the claims below), "a," "an," "the," and similar references should be construed as covering both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. All methods described herein can be performed in any suitable order, unless otherwise indicated herein or clearly contradicted by context. Any and all examples or exemplary language (e.g., "etc.") as provided herein are intended only to more clearly illustrate the systems, devices, and methods, and do not pose a limitation on the scope of the claimed systems, devices, and methods. No language in this specification should be construed as indicating any non-claimed component essential to the practice of the systems, devices, and methods.

[0582] All patents, patent publications, and other publications referenced and identified herein are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing, for example, the compositions and methodologies described therein that may be used in connection with the systems, apparatus, and methods. Those publications are provided only as having disclosures prior to the filing date of this application. Nothing in this regard should be construed as an admission that the inventors are not entitled to retroactively such disclosures by virtue of prior invention or for any other reason. All statements as to the date or expression or content of those documents are based on the information available to the applicant and do not contribute to any admission as to the accuracy of the date or content of those documents.

Claims

1. An artificial valve for use in place of a natural valve, A valve frame surrounding the distribution channel, One or more artificial valve leaflets are coupled to the valve frame, extend radially inward from the valve frame, and are located inside the flow channel. A proximal tension-applying body positioned in the proximal portion of the artificial valve, A distal tension-applying body positioned at the distal portion of the artificial valve, A seal skirt comprising a proximal end portion and a distal end portion, wherein the seal skirt is positioned radially outward from the valve frame with a space between the seal skirt and the valve frame, the proximal end portion of the seal skirt is coupled to the proximal tension-applying body, the distal end portion of the seal skirt is coupled to the distal tension-applying body, and the seal skirt is tensioned by the proximal tension-applying body and the distal tension-applying body to conform to the shape of the natural valve, and is also flexible, including a seal skirt, An artificial valve in which at least one of the proximal tension-applying body and the distal tension-applying body includes a ring extending circumferentially around the artificial valve.

2. The artificial valve according to claim 1, wherein the seal skirt surrounds the valve frame, and the central portion of the seal skirt is free from the valve frame without being coupled to it.

3. The artificial valve according to claim 1, wherein the seal skirt is elastic and configured to bend radially inward to conform to the shape of the natural valve.

4. The artificial valve according to claim 1, wherein both the proximal tension-applying body and the distal tension-applying body include a ring extending circumferentially around the artificial valve.

5. The artificial valve according to claim 1, wherein the ring is compressible and biased to expand outward.

6. The artificial valve according to claim 1, wherein the ring includes overlapping end portions.

7. The prosthetic valve according to claim 1, wherein the distal tension-applying body includes a distal anchor for the prosthetic valve.

8. The artificial valve according to claim 7, wherein the distal anchor has a hook shape.

9. The artificial valve according to claim 8, further comprising a slidable coupler coupled to the distal end portion of the seal skirt and coupled to the distal anchor, wherein the slidable coupler is slidable relative to the distal anchor.

10. The artificial valve according to claim 1, wherein the seal skirt includes a pocket, and the ring is disposed inside the pocket of the seal skirt.

11. The artificial valve according to claim 1, wherein the artificial valve is an artificial valve for the mitral valve or an artificial valve for the tricuspid valve.

12. A system for treating natural heart valves, wherein the system is: An artificial valve for replacement of natural heart valves, A valve frame surrounding the distribution channel, One or more artificial valve leaflets are coupled to the valve frame, extend radially inward from the valve frame, and are located inside the flow channel. A proximal tension-applying body positioned in the proximal portion of the artificial valve, A distal tension-applying body positioned at the distal portion of the artificial valve, A seal skirt comprising a proximal end portion and a distal end portion, wherein the seal skirt is positioned radially outward from the valve frame with a space between the seal skirt and the valve frame, the proximal end portion of the seal skirt is coupled to the proximal tension-applying body, the distal end portion of the seal skirt is coupled to the distal tension-applying body, and the seal skirt is tensioned by the proximal tension-applying body and the distal tension-applying body to conform to the shape of the natural valve, and is also flexible, including a seal skirt, At least one of the proximal tension-applying body and the distal tension-applying body includes a ring extending circumferentially around the artificial valve, A delivery system comprising a delivery system including a long shaft for delivering the artificial heart valve through the patient's vascular system to the natural heart valve, wherein the delivery system includes an implant-holding area for holding the artificial valve.

13. The system according to claim 12, wherein the seal skirt surrounds the valve frame, and the central portion of the seal skirt is free from the valve frame without being coupled to it.

14. The system according to claim 12, wherein both the proximal tension-applying body and the distal tension-applying body include a ring extending circumferentially around the artificial valve.

15. An artificial valve configured to deploy relative to a natural valve, One or more artificial valve leaflets, An inner frame supporting one or more artificial valve leaflets, An outer frame, which is positioned radially outward from the inner frame and surrounds the inner frame, having a proximal end portion and a distal end portion, and being positioned spaced apart from the inner frame with a gap between them, An artificial valve comprising one or more anchors, which are connected to the distal end portion of the outer frame and are shaped such that each anchor is positioned radially outward of one or more leaflets of the natural valve, thereby anchoring the natural valve to the natural valve.

16. The artificial valve according to claim 15, wherein each of the one or more anchors includes a hook.

17. The artificial valve according to claim 15, wherein each of the one or more anchors includes a connecting portion and a tip portion, the connecting portion being connected to the outer frame, and the tip portion being shaped to extend proximal from the connecting portion.

18. The artificial valve according to claim 17, wherein the connecting portion has a convex curvature toward the distal end.

19. The artificial valve according to claim 17, wherein the outer frame includes a plurality of struts forming a plurality of distal apex portions, and the coupling portion is coupled to one of the corresponding distal apex portions.

20. The artificial valve according to claim 15, wherein at least one of the one or more anchors includes a hinge adapted to allow the anchor to flex radially.

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