Prosthetic mitral valve with improved anchors and seal

Abstract

To solve a problem that occurs when blood flows around a valve on an outside of a prosthesis.SOLUTION: A mitral valve prosthesis includes an hourglass-shaped inner frame and a bulbous outer frame. A valve body having a plurality of leaflets is positioned within an interior region of the inner frame. The leaflets are shaped to substantially conform to an interior surface of the inner frame when the leaflets are in an open position. As a result, the gap between the leaflets and the inner frame is decreased, thereby reducing the likelihood of thrombus formation. Ventricular anchors are preferably provided along a distal end of the inner frame. The anchors extend proximally for placement behind native mitral valve leaflets. A fabric skirt may extend along an inner or outer surface of the outer frame. In preferred embodiments, the fabric skirt extends distally beyond a distal end of the outer frame and is adapted for forming a seal along the mitral valve annulus.SELECTED DRAWING: Figure 9

Description

[Technical Field]

[0001] Certain embodiments disclosed herein relate generally to prostheses for implantation within a lumen or body cavity. In particular, certain embodiments relate to expandable prostheses, such as replacement heart valves for mitral valves, that are configured to be anchored against intraluminal tissue and prevent paravalvular regurgitation. [Background technology]

[0002] Human heart valves, including the aortic, pulmonary, mitral, and tricuspid valves, essentially function as one-way valves that operate in synchronization with the pumping action of the heart. These valves allow blood to flow downstream but prevent it from flowing upstream. Diseased heart valves exhibit defects such as valve stenosis or regurgitation that impair the valve's ability to control blood flow. Such defects reduce the heart's blood pumping efficiency and can be debilitating and fatal. For example, valvular insufficiency can lead to conditions such as cardiac hypertrophy and ventricular dilation. Accordingly, considerable efforts have been made to develop methods and devices for repairing or replacing damaged heart valves.

[0003] Prostheses exist to correct problems associated with faulty heart valves. For example, mechanical heart valve prostheses and tissue-based heart valve prostheses can be used to replace faulty native heart valves. More recently, much effort has been focused on the deployment of replacement heart valves, particularly tissue-based replacement heart valves, which can be less traumatic to patients than open-heart surgery. Replacement valves are designed to be delivered by minimally invasive and even percutaneous procedures. Such replacement valves often include a tissue-based valve body coupled to an expandable frame and delivered to the annulus of the native valve.

[0004] These replacement valves are often intended to at least partially prevent blood flow. However, problems arise when blood flows around the valve on the exterior of the prosthesis. For example, in the case of replacement heart valves, paravalvular regurgitation has proven particularly troublesome. A further complication concerns the ability of such prostheses to anchor atraumatically to intraluminal tissue, such as tissue within any body lumen or cavity. Yet another complication arises when attempting to reduce the likelihood of thrombus formation within parts of the replacement valve. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent Application Publication No. 2015 / 0328000 [Patent Document 2] U.S. Patent No. 8,414,644 [Patent Document 3] U.S. Patent No. 8,652,203 [Patent Document 4] U.S. Patent Application Publication No. 2015 / 0238315 [Patent Document 5] U.S. Patent Application Publication No. 2019 / 0008640 [Patent Document 6] U.S. Patent Application Publication No. 2017 / 0056169 [Patent Document 7] U.S. Patent Application Publication No. 2016 / 0317301 [Patent Document 8] U.S. Patent Application Publication No. 2017 / 0056171 [Patent Document 9] U.S. Patent No. 8,403,983 [Patent Document 10] U.S. Patent Application Publication No. 2014 / 0277390 [Patent Document 11] U.S. Patent Application Publication No. 2014 / 0277427 [Patent Document 12] U.S. Patent Application Publication No. 2014 / 0277422 [Patent Document 13] U.S. Patent Application Publication No. 2018 / 0021129 [Patent Document 14] U.S. Patent Application Publication No. 2018 / 0055629 [Patent Document 15] U.S. Patent Application Publication No. 2011 / 0313515 [Patent Document 16] U.S. Patent Application Publication No. 2018 / 005629 Summary of the Invention [Problem to be solved by the invention]

[0006] Embodiments of the present disclosure are directed to prostheses, such as, but not limited to, replacement heart valves. Further embodiments are directed to delivery systems, devices, and / or methods of use for delivering and / or controllably deploying prostheses, such as, but not limited to, replacement heart valves, to a desired location within the body. In some embodiments, replacement heart valves and methods for delivering replacement heart valves to a native valve, such as the mitral valve, are provided.

[0007] In some embodiments, a delivery system and method are provided for delivering a replacement heart valve to the native mitral valve position. The delivery system and method utilize a transseptal approach. In some embodiments, components of the delivery system aid in flexing the delivery system to steer the prosthesis from the septum to a position within the native mitral valve. In some embodiments, a capsule is provided to house the prosthesis for delivery to the native mitral valve position. In other embodiments, the delivery system and method may be adapted to deliver an implant to a position other than the native mitral valve. [Means for solving the problem]

[0008] The present disclosure includes, but is not limited to, the following embodiments.

[0009] Embodiment 1: A mitral valve prosthesis configured to transition between a compressed position and an expanded position, the prosthesis having a proximal end and a distal end, the prosthesis comprising: a body including a plurality of circumferentially extendable struts and a plurality of longitudinally extending struts, the plurality of circumferentially extendable struts and the plurality of longitudinally extending struts forming two or more rows of cells; an inner frame including a plurality of inner frame anchoring features extending distally from the body, the inner frame having a generally hourglass shape in the expanded position; and an outer frame coupled to the inner frame, the outer frame including a plurality of connected first v-shaped struts extending along a periphery of the prosthesis and a plurality of connected first v-shaped struts each within each of the connected first v-shaped struts. an outer frame including a plurality of separate second V-shaped struts on which are mounted a plurality of separate V-shaped struts; a valve body coupled within an inner surface of the inner frame, the valve body including a plurality of leaflets configured to allow flow in a first direction and prevent flow in a second direction opposite the first direction, the leaflets conforming to the shape of the inner surface of the inner frame when the valve body is in an open position to reduce thrombus formation between the plurality of leaflets and the inner surface of the inner frame; and a textile skirt coupled to the inner surface of the outer frame and extending distally beyond the distal end of the outer frame, the textile skirt adapted to contact and form a seal with the mitral valve annulus.

[0010] Embodiment 2: The mitral valve prosthesis of embodiment 1, wherein the plurality of separate second v-shaped struts are thinner than the plurality of connected first v-shaped struts.

[0011] Embodiment 3: A mitral valve prosthesis of embodiment 1 or 2, further comprising a stiffness-improving material attached to the outer frame, the inner frame, and a plurality of inner frame anchoring features, wherein the stiffness-improving material applies tension to the inner frame anchoring features when the prosthesis is in an expanded position and does not apply tension to the inner frame anchoring features when the prosthesis is in a compressed position.

[0012] Embodiment 4: A mitral valve prosthesis of any of embodiments 1 to 3, wherein the plurality of inner frame anchoring features extend radially outward and then proximally, and each of the plurality of inner frame anchoring features terminates in an anchoring tip.

[0013] Embodiment 5: The mitral valve prosthesis of embodiment 4, wherein the distal ends of the outer frame are spaced longitudinally above each of the anchoring apices.

[0014] Embodiment 6: The mitral valve prosthesis of any of embodiments 1 to 5, wherein the distal end of the outer frame terminates proximal to the distal ends of two or more rows of cells.

[0015] Embodiment 7: The mitral valve prosthesis of any of embodiments 1 to 6, wherein the inner frame comprises a mushroom-shaped tab at the proximal end of at least one of the plurality of longitudinally extending struts.

[0016] Embodiment 8: A mitral valve prosthesis of any of embodiments 1 to 7, wherein each of the inner frame and the outer frame has a plurality of apertures at or near the proximal ends of the inner frame and the outer frame, and each of the plurality of apertures in the inner frame is approximately aligned with one aperture among the plurality of apertures in the outer frame.

[0017] Embodiment 9: The mitral valve prosthesis of any of embodiments 1 to 8, wherein the outer frame comprises a plurality of outer frame anchoring features extending radially outward.

[0018] Embodiment 10: The mitral valve prosthesis of any of embodiments 1 to 9, wherein the skirt is positioned between the inner frame and the outer frame.

[0019] Embodiment 11: The mitral valve prosthesis of any of embodiments 1 to 11, further comprising a valve body positioned within the inner frame, the valve body comprising a plurality of leaflets configured to allow flow in a first direction and prevent flow in a second, reverse direction.

[0020] Embodiment 12: The mitral valve prosthesis of any of embodiments 1 to 11, wherein the expandable replacement heart valve prosthesis is configured to function as a replacement mitral heart valve.

[0021] Embodiment 13: A mitral valve prosthesis of any of embodiments 1 to 12, wherein each of the multiple inner frame anchoring features terminates in a pair of L-shaped anchors, the pair of L-shaped anchors being radially offset from each other.

[0022] Embodiment 14: A mitral valve prosthesis of any of embodiments 1 to 13, wherein the outer frame comprises a plurality of proximally extending struts extending between the connections of adjacent connected first V-shaped struts.

[0023] Embodiment 15: The mitral valve prosthesis of embodiment 14, wherein the outer frame has circumferential shoulders spaced apart from the proximal and distal ends of the outer frame, the circumferential shoulders being the radially outermost portion of the outer frame.

[0024] Embodiment 16: A mitral valve prosthesis of embodiment 15, wherein the proximally extending struts are spaced radially inward from the circumferential shoulder, and the distal ends of each of the plurality of first V-shaped struts are spaced radially inward from the circumferential shoulder.

[0025] Embodiment 17: The mitral valve prosthesis of any of embodiments 1 to 16, wherein the expandable replacement heart valve prosthesis comprises nine inner frame anchoring features.

[0026] Embodiment 18: A delivery assembly configured to deliver an expandable replacement heart valve prosthesis, the delivery assembly comprising: a steerable delivery system configured to releasably hold the expandable replacement heart valve prosthesis in a compressed position; and the expandable replacement heart valve prosthesis configured to be expandable between a compressed position and an expanded position, the expandable replacement heart valve prosthesis comprising: an inner frame comprising a plurality of circumferentially extendable struts, a plurality of longitudinally extending struts and a plurality of inner frame anchoring features, the inner frame having a generally hourglass shape in the expanded position; and an outer frame coupled to the inner frame and comprising a plurality of connected first v-shaped struts extending along a periphery of the prosthesis, wherein the steerable delivery system is configured to sequentially expand portions of the prosthesis from the compressed position to the expanded position.

[0027] Embodiment 19: The delivery assembly of embodiment 18, wherein the outer frame further comprises a plurality of separate second V-shaped struts, each of the separate second V-shaped struts being mounted within each of the connected first V-shaped struts.

[0028] Embodiment 20: The delivery assembly of embodiment 18 or 19, wherein the steerable delivery system further comprises an anchor separator comprising a main body, a plurality of extensions extending radially away from the main body, the plurality of extensions forming a plurality of longitudinally extending grooves, each of the plurality of longitudinally extending grooves configured to receive one of a plurality of inner frame anchoring features in a compressed position, and a lumen extending longitudinally through the main body, wherein the main body and the plurality of extensions taper radially inward at the proximal and distal ends of the anchor separator.

[0029] Embodiment 21: An expandable replacement heart valve prosthesis. The prosthesis can be configured to transition between a compressed position and an expanded position. The prosthesis can include an inner frame. The inner frame can include a plurality of circumferentially extendable struts. The inner frame can include a plurality of longitudinally extending struts. The plurality of circumferentially extendable struts and the plurality of longitudinally extending struts can form two or more rows of cells. The inner frame can include a plurality of inner frame anchoring features. The inner frame can have a generally hourglass shape in the expanded position. The prosthesis can include an outer frame. The outer frame can be connected to the inner frame. The outer frame can include a plurality of connected first V-shaped struts. The plurality of connected first V-shaped struts can extend along the periphery of the prosthesis. The outer frame can include a plurality of separate second V-shaped struts. Each of the plurality of separate second V-shaped struts may be attached within each of the connected first V-shaped struts. The plurality of separate second V-shaped struts may be thinner than the plurality of connected first V-shaped struts. The prosthesis may include a stiffness-improving material attached to the outer frame. The stiffness-improving material may be attached to the inner frame. The stiffness-improving material may be attached to the plurality of inner frame anchoring features. The stiffness-improving material may apply tension to the inner frame anchoring features when the prosthesis is in an expanded position. The stiffness-improving material may not apply tension to the inner frame anchoring features when the prosthesis is in a compressed position.

[0030] Embodiment 22: The prosthesis of embodiment 21, wherein the stiffness-improving material may comprise sutures, fibers, or fabric.

[0031] Embodiment 23: The prosthesis of embodiment 21 or 22, wherein the outer frame comprises a plurality of outer frame anchoring features.

[0032] Embodiment 24: The prosthesis of embodiments 21 to 23, wherein the prosthesis may be configured for use as a replacement mitral valve.

[0033] Embodiment 25: The prosthesis of any of embodiments 21 to 24, wherein the prosthesis can include a skirt positioned between the inner frame and the outer frame. The skirt can be configured to automatically tuck into cells in the outer frame when the prosthesis is compressed.

[0034] Embodiment 26: The prosthesis of any of embodiments 21 to 25, wherein the prosthesis may include a valve body. The valve body may be positioned within the first frame. The valve body may include a plurality of leaflets configured to allow flow in a first direction and prevent flow in a second, reverse direction.

[0035] Embodiment 27: An expandable replacement heart valve prosthesis configured to transition between a compressed position and an expanded position, wherein the inner frame may comprise a generally cylindrical first frame and an inwardly curved secondary frame disposed within and attached to the generally cylindrical first frame, the inwardly curved secondary frame forming a generally hourglass shape within the longitudinal lumen of the inner frame.

[0036] Embodiment 28: The prosthesis of embodiment 27, wherein the secondary frame may comprise a plurality of longitudinal struts on the outer surface of the textile component.

[0037] Embodiment 29: The prosthesis of embodiment 27, wherein the secondary frame may comprise a fluid-filled balloon.

[0038] Embodiment 30: The prosthesis of embodiment 27, wherein the secondary frame may comprise a swellable material.

[0039] Embodiment 31: The prosthesis of any of embodiments 21 to 26, comprising the features of any one of embodiments 27 to 30.

[0040] Embodiment 32: A prosthesis of any of embodiments 21 to 31, wherein each of the multiple inner frame anchoring features can terminate in a pair of L-shaped anchors, the pair of L-shaped anchors being radially offset from each other.

[0041] Embodiment 33: A delivery system configured to deliver a prosthesis comprising a plurality of anchors, including any of the prostheses described herein. The delivery system includes an anchor separator comprising: a body; a plurality of extensions extending radially away from the body, the plurality of extensions forming a plurality of longitudinally extending grooves for receiving anchors of the prosthesis; and a lumen extending longitudinally through the body. The body and the plurality of extensions taper radially inward at proximal and distal ends of the anchor separator.

[0042] Embodiment 34: An expandable replacement cardiac prosthesis. The prosthesis may be configured to transition between a compressed position and an expanded position. The prosthesis may include a frame. The frame may have an inlet side. The frame may have a middle portion. The frame may have an outlet side. The frame may have a reduced diameter from at least the inlet side to the middle portion. The prosthesis may include a valve body including a plurality of leaflets positioned within the frame. Each of the leaflets may have an inlet end positioned along a reduced diameter portion of the frame.

[0043] Embodiment 35: The prosthesis of embodiment 34, wherein the frame may have an hourglass shape.

[0044] Embodiment 36: An expandable replacement heart valve prosthesis. The prosthesis can be configured to transition between a compressed position and an expanded position. The prosthesis can include an inner frame. The inner frame can include a plurality of inner frame anchoring features. These features can extend from a lower portion of the inner frame. The prosthesis can include an outer frame. The outer frame can be coupled to the inner frame. The prosthesis can include a stiffness-enhancing material. The material is attached to the outer frame. The material is attached to the inner frame. The material is attached to the plurality of inner frame anchoring features. The stiffness-enhancing material can apply tension to the inner frame anchoring features when the prosthesis is in the expanded position. The material may not apply tension to the inner frame anchoring features when the prosthesis is in the compressed position.

[0045] Embodiment 37: The prosthesis of embodiment 36, wherein the inner frame anchoring feature may include a plurality of anchors. The anchors may extend radially outward from the inner frame. The anchors may extend generally toward an upper portion of the inner frame.

[0046] Embodiment 38: The prosthesis of embodiment 36 or 37, wherein the outer frame can extend over the inner frame.

[0047] Embodiment 39: The prosthesis of any of embodiments 36 to 38, wherein the stiffness-improving material may comprise sutures, fibers, or fabric material. The material may extend from the lower portion of the outer frame. The material may be attached to the inner frame anchoring feature. The material may be attached to the lower portion of the inner frame.

[0048] Embodiment 40: An expandable replacement heart valve prosthesis. The prosthesis can be configured to transition between a compressed position and an expanded position. The prosthesis can include a frame. The frame can include a plurality of connected first V-shaped struts. The struts can extend along the periphery of the prosthesis. The frame can include a plurality of separate second V-shaped struts. Each of the separate second V-shaped struts can be mounted within a respective connected first V-shaped strut. The plurality of separate second V-shaped struts can be thinner than the plurality of connected first V-shaped struts.

[0049] Embodiment 41: An expandable replacement heart valve prosthesis. The prosthesis can be configured to transition between a compressed position and an expanded position. The prosthesis can include a frame. The frame can include a plurality of circumferentially extendable struts. The frame can include a plurality of longitudinally extending struts. The plurality of circumferentially extendable struts and the plurality of longitudinally extending struts can form two or more rows of cells.

[0050] Embodiment 42: A frame that may comprise a cell pattern as shown and described in Figures 3, 4, and / or 5A.

[0051] Embodiment 43: A prosthesis comprising one or more features of embodiments 1 to 42.

[0052] Embodiment 44: A method for treating valvular insufficiency comprising one or more features of embodiments 1 to 43.

[0053] Embodiment 45: A delivery system for delivering a prosthesis comprising one or more features of embodiments 1 to 44.

[0054] Embodiment 46: The mitral valve prosthesis of any of embodiments 1 to 14, wherein the free edge of the distal end of each of the plurality of leaflets is spaced apart from the inner frame.

[0055] Embodiment 47: A mitral valve prosthesis of any of embodiments 1 to 15, wherein the textile skirt is connected to the outer surface of the distal end of the inner frame, and the textile skirt is maintained in a tensioned state between the outer frame and the inner frame.

[0056] Embodiment 48: The mitral valve prosthesis of any of embodiments 1 to 16, wherein the textile skirt is sufficiently flexible to conform to the mitral valve annulus.

[0057] Embodiment 49: A mitral valve prosthesis configured to transition between a compressed position and an expanded position, the prosthesis having a proximal end and a distal end, the prosthesis comprising: a body including a plurality of circumferentially extendable struts and a plurality of longitudinally extending struts, the plurality of circumferentially extendable struts and the plurality of longitudinally extending struts forming two or more rows of cells; an inner frame including a plurality of inner frame anchoring features extending distally from the body, the inner frame having a generally hourglass shape in the expanded position; and an outer frame coupled to the inner frame, the outer frame including a plurality of coupled first v-shaped struts extending along a periphery of the prosthesis and coupled The valve includes an outer frame having a plurality of separate second V-shaped struts, each mounted within a respective one of the first V-shaped struts; a valve body coupled within the inner surface of the inner frame, the valve body having a plurality of leaflets configured to allow flow in a first direction and prevent flow in a second direction opposite the first direction; and a textile skirt coupled under tension to the inner surface of the outer frame and to the outer surface of the distal end of the inner frame, the textile skirt extending distally beyond the distal end of the outer frame and adapted to conform to the mitral valve annulus.

[0058] Embodiment 50: A mitral valve prosthesis configured to transition between a compressed position and an expanded position, the prosthesis having a proximal end and a distal end, the prosthesis comprising: a body including a plurality of circumferentially extendable struts and a plurality of longitudinally extending struts, the plurality of circumferentially extendable struts and the plurality of longitudinally extending struts forming two or more rows of cells; an inner frame including a plurality of inner frame anchoring features extending distally from the body, the inner frame having a generally hourglass shape in the expanded position; and an outer frame coupled to the inner frame, the outer frame including a plurality of connected first V-shaped struts extending along a periphery of the prosthesis and a plurality of separate second V-shaped struts each mounted within one of the connected first V-shaped struts.

[0059] These and other features, aspects, and advantages are described hereinafter with reference to the drawings, which are intended to illustrate embodiments of the prostheses, including embodiments of the various components of these prostheses. [Brief explanation of the drawings]

[0060] [Figure 1] 1 illustrates an embodiment of a multi-portion replacement prosthesis. [Figure 2] 2 shows an embodiment of the inner frame of the multi-portion replacement prosthesis shown in FIG. 1. FIG. [Figure 3] 3 is a diagram showing a flat pattern of one embodiment of the inner frame shown in FIG. 2. FIG. [Figure 4] FIG. 3 is a view showing a portion of the inner frame of FIG. 2. [Figure 5A] FIG. 10 shows an inner frame having an hourglass shape. [Figure 5B] FIG. 10 shows an inner frame having an hourglass shape. [Figure 5C] FIG. 10 shows an inner frame having an hourglass shape. [Figure 5D] FIG. 10 shows an inner frame having an hourglass shape. [Figure 5E] FIG. 10 shows an inner frame having an hourglass shape. [Figure 5F-5G] 5A-5E show valve leaflets opening within a frame having an hourglass shape as shown in FIG. 5A-5E. [Figure 5H-5I] 5A-5E show valve leaflets opening within a frame having an hourglass shape as shown in FIG. 5A-5E. [Figure 5J] 5A-5E are cross-sectional views of valve leaflets in an open position within a frame having an hourglass shape as shown in FIGS. 5A-5E. [Figure 5K] 5A-5E are cross-sectional views of valve leaflets in a closed position within a frame having an hourglass shape as shown in FIGS. 5A-5E. [Figure 6A] 2 shows one embodiment of the outer frame of the multi-portion replacement prosthesis shown in FIG. 1. FIG. [Figure 6B] 2 shows one embodiment of the outer frame of the multi-portion replacement prosthesis shown in FIG. 1. FIG. [Figure 6C] 2 shows one embodiment of the outer frame of the multi-portion replacement prosthesis shown in FIG. 1. FIG. [Figure 6D] 2 shows one embodiment of the outer frame of the multi-portion replacement prosthesis shown in FIG. 1. FIG. [Figure 7A] FIG. 7 shows the flat pattern of the outer frame of FIG. 6 in a compressed configuration. [Figure 7B] FIG. 7 shows the flat pattern of the outer frame of FIG. 6 in an expanded configuration. [Figure 7C] 13A-13C show alternative embodiments of flat patterns for the outer frame. [Figure 7D] 13A-13C show alternative embodiments of flat patterns for the outer frame. [Figure 8A] 13A-13C show alternative flat patterns for the outer frame. [Figure 8B] 13A-13C show alternative flat patterns for the outer frame. [Figure 9] 1 shows a multi-portion replacement prosthesis with an outer skirt. [Figure 10] 1 shows a multi-portion replacement prosthesis with an outer skirt. [Figure 11] 1 shows a multi-portion replacement prosthesis with an outer skirt. [Figure 12] 10A-10C show a multi-portion replacement prosthesis with outer frame anchoring features. [Figure 13A] 10A-10C illustrate an automatic tacking feature of an embodiment of the prosthesis of the present disclosure. [Figure 13B] 10A-10C illustrate an automatic tacking feature of an embodiment of the prosthesis of the present disclosure. [Figure 14A] 10A-10C illustrate an embodiment for improving the stiffness of the inner frame anchoring features. [Figure 14B] 10A-10C illustrate an embodiment for improving the stiffness of the inner frame anchoring features. [Figure 15] 13A-13C illustrate an alternative embodiment for improving the stiffness of the inner frame anchoring feature. [Figure 16] FIG. 1 shows the evaluation of prosthetic function before release. [Figure 17A] 1 illustrates one embodiment of a replacement prosthesis. [Figure 17B] 1 illustrates one embodiment of a replacement prosthesis. [Figure 18A] 1 illustrates an embodiment of an alternative replacement prosthesis. [Figure 18B] 1 illustrates an embodiment of an alternative replacement prosthesis. [Figure 19] 1 illustrates an embodiment of an alternative replacement prosthesis. [Figure 20] 1 illustrates an embodiment of an alternative replacement prosthesis. [Figure 21] 1 illustrates one embodiment of a replacement prosthesis. [Figure 22] 10A-10C illustrate an embodiment of an inner frame of an alternative replacement prosthesis. [Figure 23]10A-10C illustrate an embodiment of the outer frame of an alternative replacement prosthesis. [Figure 24] FIG. 1 illustrates one embodiment of an anchoring element. [Figure 25A] FIG. 1 illustrates one embodiment of an anchor separator. [Figure 25B] FIG. 1 illustrates one embodiment of an anchor separator. [Figure 26] 10A-10C illustrate one embodiment of an anchor separator within the frame of a replacement prosthesis. [Figure 27A] 10A-10C illustrate one embodiment of an anchor separator when used with a replacement prosthesis. [Figure 27B] 10A-10C illustrate one embodiment of an anchor separator when used with a replacement prosthesis. [Figure 28A] 10A-10C illustrate one embodiment of a suturing system for attachment to a delivery system. [Figure 28B] 10A-10C illustrate one embodiment of a suturing system for attachment to a delivery system. [Figure 29] 1 illustrates an embodiment of an alternative replacement prosthesis. [Figure 30A] 1 illustrates an embodiment of a multi-portion replacement prosthesis. [Figure 30B] 1 illustrates an embodiment of a multi-portion replacement prosthesis. [Figure 30C] 1 illustrates an embodiment of a multi-portion replacement prosthesis. [Figure 30D] 1 illustrates an embodiment of a multi-portion replacement prosthesis. [Figure 31] 13A-13C show an alternative embodiment of an inner frame having a secondary inner frame with an hourglass shape. [Figure 32] FIG. 1 is a schematic diagram of a transseptal delivery approach. [Figure 33] 1 is a schematic diagram of a valve prosthesis positioned within a native mitral valve. [Figure 34] 1 is a schematic diagram of a valve prosthesis positioned within a native mitral valve. [Figure 35] FIG. 1 illustrates one embodiment of a delivery system for use with any of the prostheses disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0061] The specification and drawings present aspects and features of the present disclosure in the context of multiple embodiments of prostheses, replacement heart valves, and methods configured for use within a patient's vasculature, such as for replacing the patient's native heart valve. These embodiments may be discussed with reference to replacing a particular valve, such as the patient's mitral valve. However, it should be understood that the features and concepts discussed herein are also applicable to replacing other types of valves, including, but not limited to, aortic, pulmonary, and tricuspid valves. Furthermore, it should be understood that the features and concepts discussed herein are also applicable to products other than heart valve implants. For example, the controlled positioning features, deployment features, and / or fixation features described herein are also applicable to medical implants, such as other types of expandable prostheses, for use elsewhere in the body, e.g., in a vein. Furthermore, the specific features of the prosthesis should not be understood as limiting, and the features of any one embodiment discussed herein may be combined with the features of other embodiments as desired and appropriate.

[0062] Certain terms may be used in the following description for reference purposes only and are not intended as limiting. For example, terms such as "upper," "lower," "upward," "downward," "upward," "downward," "top," "bottom," and similar terms indicate directions within the drawings to which reference is made. Terms such as "proximal," "distal," "radially outward," "radially inward," "outer," "inner," and "lateral" describe the orientation and / or location of components or portions of elements within a consistent but arbitrary frame of reference made clear by reference to the text and associated drawings describing the components or elements being discussed. Such terms may include those specifically mentioned above, derivatives thereof, and words of similar import. Similarly, terms such as "first," "second," and other such numerical terms referring to structures do not imply any sequence or order unless clearly indicated by context.

[0063] In some embodiments, the term "proximal" may refer to parts of a prosthesis or components thereof that are located closer to the device and system operator (e.g., the clinician implanting the prosthesis). The term "distal" may refer to parts of a prosthesis or components thereof that are located farther from the device and system operator (e.g., the clinician implanting the prosthesis). However, it should be understood that the terms may be reversed depending on the delivery technique utilized (e.g., a transapical approach compared to a transseptal approach). In some situations, the prosthesis and its components may be oriented such that the upper end is the proximal portion and the lower end is the distal portion.

[0064] In some situations, the upper end of a prosthesis and its components may be the inflow end and the lower end may be the outflow end. For example, a valve body used with the prosthesis may allow flow from the upper end to the lower end. However, it should be understood that the inflow and outflow ends may be reversed. For example, a valve body used with the prosthesis may allow flow from the lower end to the upper end.

[0065] The longitudinal axis of a prosthesis or component thereof may be defined as a central axis extending through the center of the prosthesis or component (e.g., the prosthesis, outer frame, and / or inner frame) between the upper and lower ends of the prosthesis or component. The prostheses described herein may be replacement valves that may be designed to replace damaged or diseased native heart valves, such as the mitral valve, as discussed above. It should be understood that the prosthesis is not limited to being a replacement valve.

[0066] As described in more detail below, the prosthesis may include an inner frame and / or an outer frame, or an inner portion and / or an outer portion. In some embodiments, the inner frame can be a valve frame designed to support the valve body. In some embodiments, the outer frame can be a sealing frame designed to form a seal around the periphery of the outer frame. For example, the outer frame can engage and form a seal with tissue of the body cavity around the periphery of the outer frame. In some embodiments described herein, the outer frame is attached to the inner frame at one or more fixed couplings such that the outer frame is fixed relative to the inner frame at one or more positions. It should be understood that the outer frame can be attached to the inner frame by one or more movable couplings, such as, but not limited to, rails. This is advantageous because the outer frame can be adjustable relative to the inner frame to better conform to the anatomy of the patient's body cavity.

[0067] The inner and / or outer frames may be described as having an upper region, a middle region, and a lower region. In some situations, such as when the prosthesis is positioned within a native heart valve, the upper region may be positioned generally on the annulus (i.e., above the plane of the annulus), the middle region may be positioned generally within the annulus (i.e., in the plane of the annulus), and the lower region may be positioned subannular (i.e., below the plane of the annulus). However, it should be understood that in some situations, the positioning of the inner and / or outer frames relative to the annulus may differ. Furthermore, it should be understood that in some embodiments, the inner and / or outer frames may omit one or more of the upper, middle, and / or lower regions.

[0068] While specific combinations of inner and outer frames are described herein, it should be understood that the inner and outer frames are interchangeable. This may advantageously allow the prosthesis to be configured to better fit the patient's native anatomy. Furthermore, it should be understood that the inner and outer frames can be attached prior to delivery to the patient, but the inner and outer frames can be delivered separately and later attached within the patient. This may advantageously reduce the crimp profile when delivering the frames to the body cavity. The prostheses described herein may be used as stand-alone devices. For example, the prosthesis may be deployed in a native mitral valve and appropriately sized and shaped to replace the function of the native mitral valve. However, it should be understood that the prostheses described herein may be used with other devices. For example, one or more clips may be used to hold the native leaflets of a heart valve together. This may advantageously allow a smaller prosthesis to be used in a native mitral valve.

[0069] Replacement Valve and Frame Embodiments FIG. 1 illustrates one embodiment of a frame for a multi-portion prosthesis 100 in an expanded configuration. The prosthesis 100 may include, but is not limited to, an inner frame 120, an outer frame 140, a valve body 160 (shown in FIGS. 9-11), and a skirt 180 (also shown in FIGS. 9-11). The longitudinal axis of the prosthesis 100 may be defined as a central axis extending through the center of the prosthesis 100 between its upper and lower ends. In some situations, the prosthesis 100 may be oriented such that the upper end of the prosthesis 100 is the proximal portion and the lower end of the prosthesis 100 is the distal portion. The illustrated prosthesis 100 and other prostheses described herein may include components that are self-expanding or balloon-expandable. For example, in some embodiments, the inner frame 120 and / or the outer frame 140 may be self-expanding. Prosthesis 100 and the other prostheses described herein may be replacement valves that may be designed to replace damaged or diseased native heart valves, such as the mitral valve, as discussed above. It should be understood that prosthesis 100 and the other prostheses described herein are not limited to being replacement valves.

[0070] Embodiments of the disclosed prosthesis 100 may have a reduced crimp inner diameter (ID) such as 25Fr, 24Fr, 23Fr, 22Fr, 21Fr, or 20Fr. Embodiments of the disclosed prosthesis 100 may have a reduced crimp ID of less than 25Fr, less than 24Fr, less than 23Fr, less than 22Fr, less than 21Fr, or less than 20Fr. Embodiments of the disclosed prosthesis 100 may have a reduced crimp ID of greater than 25Fr, greater than 24Fr, greater than 23Fr, greater than 22Fr, greater than 21Fr, or greater than 20Fr. In some embodiments, the prosthesis 100 may have a crimp length of 48, 47, 46, 45, 44, 43, 42, 41, or 40 mm. In some embodiments, the prosthesis 100 may have a crimp length of less than 48, 47, 46, 45, 44, 43, 42, 41, or 40 mm. In some embodiments, the prosthesis 100 may have a crimp length of more than 48, 47, 46, 45, 44, 43, 42, 41, or 40 mm. In some embodiments, the prosthesis 100 may require a retraction force of only 60, 55, 50, 45, or 40 lbs to compress the prosthesis 100. In some embodiments, the prosthesis 100 may require a retraction force of only less than 60, 55, 50, 45, or 40 lbs to compress the prosthesis 100. In some embodiments, the prosthesis 100 may require a retraction force of only more than 60, 55, 50, 45, or 40 lbs to compress the prosthesis 100.

[0071] As further disclosed below, multi-portion prosthesis 100 can be made from one or more frames, such as one, two, or three frames. In some embodiments, prosthesis 100 can be a dual-frame design having an inner frame and an outer frame. In some embodiments, the inner and outer frames are integrally formed into one frame. In other embodiments, the frames can be separate and connected together.

[0072] Inner frame FIG. 2 shows the inner frame 120 of the prosthesis 100 with the outer frame 140 removed for clarity. Additionally, FIG. 3 shows the flattened pattern of the inner frame 120. The inner frame 120 may generally comprise an inner frame body 122 and an inner frame anchoring feature 124 (also known as a ventricular anchor or distal anchor when used in the mitral valve). The inner frame body 122 may have an upper region 126, a middle region 128, and a lower region 130. As shown, the inner frame body 122 may have a generally cylindrical shape such that the upper region 126, the middle region 128, and the lower region 130 have generally equal diameters. However, it should be understood that the diameters of the upper region 126, the middle region 128, and / or the lower region 130 may vary, such as an hourglass shape, as discussed below in connection with FIGS. 5A-5E. For example, in some embodiments, the diameter of intermediate region 128 can be larger / smaller than the upper and lower regions 126, 130, such that frame body 122 has a generally bulbous shape. In some embodiments, the diameter of lower region 130 can be larger than the diameter of upper region 126. In other embodiments, the diameter of upper region 126 can be larger than the diameter of lower region 130. Additionally, while inner frame body 122 has been described and illustrated as being cylindrical or having a circular cross-section, it should be understood that all or a portion of inner frame body 122 can have a non-circular cross-section, such as, but not limited to, a D-shape, an elliptical shape, or other oval cross-sectional shape.

[0073] In some situations, such as when prosthesis 100 is positioned within a native mitral valve, upper region 126 may be positioned generally supranuclear (i.e., above the plane of the annulus), middle region 128 may be positioned generally intraannular (i.e., in the plane of the annulus), and lower region 130 may be positioned subannular (i.e., below the plane of the annulus). However, it should be understood that in some situations, the positioning of inner frame 120 relative to the annulus may be different. For example, middle region 128 may be positioned supranuclear. Furthermore, it should be understood that in some embodiments, inner frame 120 may omit one or more of upper region 126, middle region 128, and / or lower region 130.

[0074] 2, inner frame 120 may include inner frame anchoring features 124 (in some embodiments, ventricular anchors) that may extend generally downward and / or radially outward at or near the lower end of lower region 130 of inner frame body 122. After extending radially outward, inner frame anchoring features 124 may extend upward toward upper region 126. As discussed in further detail below, components of inner frame 120, such as inner frame anchoring features 124, may be used to attach or secure prosthesis 100 to the native valve. For example, in some circumstances, inner frame anchoring features 124 may be used to attach or secure prosthesis 100 to the native mitral valve. In one such embodiment, the inner frame anchoring features 124 may be positioned to contact or engage the native mitral valve annulus on the lateral side of the ventricle, tissue beyond the native annulus on the lateral side of the ventricle, the native valve leaflets on the lateral side of the ventricle, and / or other tissue at or around the implantation location during one or more phases of the cardiac cycle, such as systole and / or diastole. When positioned within the native mitral valve, the inner frame anchoring features 124 may advantageously eliminate, prevent, or limit upward movement of the prosthesis 100 when subjected to an upward force, such as that applied to the prosthesis 100 during systole. As shown, the prosthesis 100 may have nine inner frame anchoring features 124, although some embodiments may have more or fewer inner frame anchoring features 124, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 inner frame anchoring features 124.

[0075] With continued reference to the inner frame 120 shown in FIG. 2 , the inner frame anchoring feature 124 can have an end or tip 124a positioned radially outward relative to the longitudinal axis of the prosthesis 100. The inner frame anchoring feature 124 can extend at or near the lower end of the lower region 130 of the inner frame body 122. As shown, the inner frame anchoring feature 124 can be formed from multiple individual anchors extending from the frame body 122. These anchors can extend downward from one or more attachment points to the frame body 122, including, but not limited to, the lower tip cells 134b. These anchors can be bent to extend generally radially outward relative to the longitudinal axis of the prosthesis 100. As shown in the illustrated embodiment, the anchors can extend upward toward the end or tip 124a.

[0076] As shown in the illustrated embodiment, the tip or end 124a extends upward in a direction parallel or generally parallel to the longitudinal axis of the prosthesis 100. In some embodiments, the tip or end 124a of the anchoring feature 124 may extend generally perpendicular to the longitudinal axis of the prosthesis 100. This may advantageously increase the tissue contact area of ​​the anchor tip 124a. This increased tissue contact area may advantageously reduce the stress applied to the tissue by the tip 124a, thereby reducing the amount of pressure and potential trauma to the tissue. In some embodiments, the tip or end 124a of the anchoring feature 124 extends radially inward toward the longitudinal axis and / or radially outward away from the longitudinal axis.

[0077] Such tips or ends 124a are advantageous because they can provide an atraumatic surface that can be used to contact or engage intraluminal tissue without causing unnecessary or undesirable trauma to the tissue. For example, the tips or ends 124a can form a flat, substantially flat, curved, or other blunt surface, allowing the tips to engage and / or grasp tissue without necessarily penetrating or perforating the tissue. Loop ends or loop anchors, such as those shown in FIG. 5A, can help prevent the frame from snagging on structures at or near the treatment location. For example, each loop can be configured so that when the prosthesis 100 is deployed in situ and the anchoring features 124 expand away from the frame body 122, movement of each loop from the delivery position to the deployed position avoids snagging on papillary muscles. In some embodiments, the inner frame anchoring features 124 can include a lacrosse-head-shaped tip or end 124a. In some embodiments, the tip or end 124a of the inner frame 120 may have a split design, as shown in FIG.

[0078] The anchoring features 124 may include nine individual anchors, although it should be understood that more or fewer individual anchors may be used. For example, the number of individual anchors may be selected as a multiple of the number of commissures in the valve body 160 (shown in FIG. 10 ). Thus, in the case of a prosthesis 100 having a valve body 160 with three commissures, the inner frame anchoring features 124 may have three individual anchors (a 1:1 ratio), six individual anchors (a 2:1 ratio), nine individual anchors (a 3:1 ratio), twelve individual anchors (a 4:1 ratio), fifteen individual anchors (a 5:1 ratio), or any other multiple of three. It should be understood that the number of individual anchors need not correspond to the number of commissures in the valve body 160. Furthermore, while the prosthesis 100 includes anchoring features 124 each having twelve anchors, it should be understood that more or fewer anchors may be used.

[0079] Referring to the inner frame 120 shown in FIGS. 9-11 and 17B, the inner frame anchoring features 124 can include covers and / or cushions 138 to surround or partially surround at least a portion of the inner frame anchoring features 124, such as the tips or ends 124a. These covers and / or cushions 138 can be similar to those described in U.S. Patent Application Publication No. 2015 / 0328000, which is incorporated herein by reference in its entirety. The covers and / or cushions 138 can either fit snugly around the tips 124a of the inner frame anchoring features 124 or have additional padding such that the covers extend radially away from the inner frame body 122. As shown in the illustrated embodiment, the covers and / or cushions 138 are attached to a subset of the anchors of the inner frame anchoring features 124 so that they are used for every third anchor. In some embodiments, the outer frame anchoring feature 144 can include a cover and / or cushion to surround or partially surround at least a portion of the outer frame anchoring feature 144, such as the tip or end 144a.

[0080] It should be understood that more or fewer covers and / or cushions 138 may be used with the anchors of the inner frame anchoring feature 124. For example, a cover and / or cushion 138 may be used on every other anchor, such that the ratio of covers and / or cushions 138 to anchors is 1:2. In another example, a cover and / or cushion 138 may be used on every anchor (as shown in FIGS. 9-11). In some embodiments, all anchors may have covers and / or cushions, but some of the anchors have less cushioning than the other anchors. In some embodiments, all anchors may have padded covers. In other embodiments, all anchors may have form-fitting cushions.

[0081] The cover and / or cushion 138 may be formed from a deformable material. When a top portion of the cover and / or cushion 138 is subjected to pressure from a downward force, the cover and / or cushion 138 may compress and expand laterally outward. Such a force may be applied to the cover and / or cushion 138, for example, when the cover and / or cushion 138 contacts the ventricular aspect of the mitral valve annulus during systole. The compression and outward expansion of the cover and / or cushion 138 may increase the surface area of ​​the cover and / or cushion 138 in contact with the tissue, thereby reducing the applied pressure on the tissue and potentially reducing trauma.

[0082] The inner frame 120 can be formed from a number of different materials, including, but not limited to, shape memory metals such as Nitinol. The inner frame 120 can be formed from a plurality of struts forming open cells, as discussed below. In some embodiments, the inner frame 120 can have a stiffer structure compared to other components of the prosthesis 100, including, but not limited to, the outer frame 140. This can be achieved, for example, by the size and configuration of the struts. This stiffer structure can have a stronger resistance to deformation when subjected to stress. This can be advantageous during certain portions of the cardiac cycle, such as systole, when the inner frame 120 can experience significant stress at the inner frame anchoring features 124. This stiffer structure can also be advantageous when the valve body 160 is positioned within the inner frame 120 to maintain the shape of the valve body 160. Furthermore, this stiffer structure can be advantageous when the inner frame 120 is used for a valve-in-valve procedure, in which an auxiliary prosthesis is positioned within the inner frame 120. However, while the inner frame 120 has been described as having a more rigid structure, it should be understood that in some embodiments, the inner frame 120 can have a more flexible structure. For example, the inner frame 120 can have a structure that is approximately as flexible as or more flexible than other components of the prosthesis 100, such as the outer frame 140.

[0083] The diameters of the upper region 126, middle region 128, and / or lower region 130 of the inner frame body 122 can be selected so that the inner frame body 122 is sufficiently spaced from the body cavity when the prosthesis 100 is positioned therein. For example, in embodiments in which the prosthesis 100 is positioned within a native mitral valve, the inner frame body 122 can have a diameter less than the diameter of the native mitral valve annulus. In situations in which the native mitral valve annulus has a diameter of approximately 40 mm, the diameter of the inner frame body 122 can be approximately 30 mm. Thus, the diameter of the inner frame body 122 can be approximately 75% of the diameter of the native mitral valve annulus.

[0084] In some embodiments, the diameter of the inner frame body 122 may be between about 40% and about 90% of the diameter of the native annulus, between about 60% and about 85% of the diameter of the native annulus, between about 70% and about 80% of the diameter of the native annulus, any other subrange between these ranges, or any other percentage as desired. In some embodiments, the diameter of the inner frame body 122 can be in the range of about 20 mm to about 40 mm when expanded, in the range of about 25 mm to about 35 mm when expanded, in the range of about 28 mm to about 32 mm when expanded, other subranges within these ranges when expanded, or any other diameter when expanded as desired. While the inner frame body 122 has been described and illustrated as being cylindrical or having a circular cross-section, it should be understood that all or a portion of the inner frame body 122 may have a non-circular cross-section, such as, but not limited to, a D-shape, an ellipse, or any other oval cross-sectional shape.

[0085] In other embodiments, the diameters of portions of inner frame body 122, such as upper region 126, middle region 128, and / or lower region 130, can be selected such that inner frame body 122 is positioned at the periphery of a body cavity. For example, in embodiments in which prosthesis 100 is positioned within a native mitral valve, inner frame body 122 can have a diameter approximately equal to the diameter of the native mitral valve annulus.

[0086] FIG. 4 shows a portion of the inner frame body 122. As shown, the inner frame body 122 can include multiple struts, at least some of which can define cells 134a-134b. Any number of strut configurations can be used, such as the illustrated rings of undulating struts that form ovals, ellipses, rounded polygons, and teardrop shapes, but also chevrons, diamonds, curved shapes, and various other shapes. The upper row of cells 134a and the lower row of cells 134b can have a diamond / parallelogram or approximate diamond / parallelogram shape. The cells 134a-134b in these rows can be formed by a combination of struts. As shown in the illustrated embodiment, the upper row of cells 134a is formed by a first set of circumferentially expandable struts 136a located at the top and bottom and a longitudinally extending strut 138. The lower row of cells 134b may be formed from a second set of circumferentially expandable struts 136b located at the top and bottom and longitudinally extending struts 138, which may be a continuation of the longitudinally extending struts described above. As shown, the upper row of cells 134a and the lower row of cells 134b may share a circumferentially expandable strut. For example, the bottom strut of the upper row of cells 134a and the top strut of the lower row of cells 134b may be shared. The first set of struts 136a and the second set of struts 136b may have a zigzag or wavy shape forming a repeating "V" shape. While the struts 136a-136b have generally been described and illustrated as being straight segments, it should be understood that some or all of the struts 136a-136b may not form completely straight segments. For example, struts 136a-136b may have some curvature such that the upper and / or lower extremities are curved as shown in FIG.

[0087] 4, the longitudinally extending strut 138 can extend substantially from the bottom of the inner frame body 122 to the top of the inner frame body 122. Advantageously, the longitudinally extending strut 138 can have the effect of experiencing little or no strain during crimping. The longitudinally extending strut 138 can be a single unitary strut that extends through both rows of cells 134a / 134b. Furthermore, as shown, each cell of the rows of cells 134a / 134b can be circumferentially located between the longitudinally extending struts 138.

[0088] As shown in the illustrated embodiment, the upper row of cells 134a and the lower row of cells 134b extend in a direction that is generally parallel to the longitudinal axis of the prosthesis 100. There may be a row of 18 cells 134a and a row of 18 cells 134b. While each cell 134a-134b is shown as having the same shape as, but mirroring, the other cells 134a-134b in the same row, it should be understood that the shapes of the cells 134a-134b within a row can differ. Furthermore, it should be understood that any number of rows of cells can be used, and that any number of cells can be included within those rows. In some embodiments, the number of cells can correspond to the number of anchors or anchor tips that form the inner frame anchoring feature 124. In some embodiments, both rows of cells 134a-134b can have different numbers of cells. It should be understood that fewer or more rows of cells can be used.

[0089] The shape of the cells 134a-134b may allow the cells 134a-134b to shorten as the inner frame 120 expands. Therefore, one or more of the cells 134a-134b may allow the inner frame 120 to shorten as the inner frame 120 expands. The shortening of the inner frame 120 may be utilized to secure the prosthesis to intraluminal tissue within the body cavity, such as tissue located at or adjacent to the native valve, including, but not limited to, the native annulus and / or leaflets. For example, the expansion of the inner frame 120 may allow the inner frame anchoring features 124 to extend radially outward to engage the tissue of the body cavity, closer to the tissue of the body cavity, such as the native annulus and / or leaflets. In some embodiments, the use of longitudinally extending struts 138 may mitigate this shortening.

[0090] 2, the inner frame 120 may include tabs (or locking tabs) 104 extending from a portion of the inner frame 120. These tabs 104 may extend at or near the upper end of the upper region 126 of the inner frame body 122, such as at the upper tips of the cells 134a. The inner frame 120 may include 12 locking tabs 104, although it should be understood that a greater or lesser number of locking tabs, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 11, may be used. The locking tabs 104 may extend generally upward from the upper region 126 of the inner frame body 122 in a direction generally aligned with the longitudinal axis of the prosthesis 100. As shown in the illustrated embodiment, the locking tabs 104 may comprise longitudinally extending struts 132a. At the upper end of strut 132a, locking tab 104 may include an enlarged head 132b. As shown, enlarged head 132b may have a semicircular or semi-elliptical shape that forms a "mushroom" shape with strut 132a.

[0091] In some embodiments, inner frame 120 may include eyelets 106. Eyelets 106 may be advantageously used to couple inner frame 120 to outer frame 140. For example, sutures may be threaded through eyelets 106 for coupling to eyelets 106 of outer frame 140. In some embodiments, eyelets 106 may be used for coupling to other components of the prosthesis in which inner frame 120 is used, such as, but not limited to, a valve body and / or a skirt.

[0092] Although the locking tabs 104 have been described as being attached to the inner frame body 122, it should be understood that the locking tabs 104 may be attached to other portions of the prosthesis 100, such as, but not limited to, the outer frame body 142. For example, in some embodiments, the locking tabs 104 may extend from the upper end of the upper region 146 of the outer frame body 142. Furthermore, it should be understood that portions or the entire locking tab 104 may be omitted. For example, in some embodiments, the struts 132a may be omitted such that the enlarged heads 132b and the eyelets 106 are positioned at the upper end of the upper region 126 of the inner frame body 122, such as at the upper tip of the cells 134a.

[0093] In some embodiments, each tab 104 may be vertically aligned with an inner frame anchoring feature 124. In some embodiments, each tab 104 is circumferentially offset from an inner frame anchoring feature 124. In some embodiments, there are the same number of tabs 104 as inner frame anchoring features 124. In some embodiments, there are a different number of tabs 104 than inner frame anchoring features 124. There can be more tabs 104 than inner frame anchoring features 124. There can be fewer tabs 104 than inner frame anchoring features 124.

[0094] In some embodiments, the tabs 104 can be advantageously used to couple the inner frame 120 to multiple types of delivery systems. For example, the shape of the tabs 104 can be used to secure the inner frame 120 to a "slot"-based delivery system. The eyelets 106 can be used to secure the inner frame 120 to a "tether"-based delivery system, such as those that use sutures, wires, or fingers to control the delivery of the inner frame 120 and prosthesis. This can advantageously facilitate in-situ recapture and repositioning of the inner frame 120 and prosthesis. In some embodiments, inner frame 120 and prosthesis can be used with delivery systems described herein, including but not limited to those described in U.S. Patent No. 8,414,644, U.S. Patent No. 8,652,203, U.S. Patent Application Publication No. 2015 / 0238315, U.S. Patent Application Publication No. 2019 / 0008640, U.S. Patent Application Publication No. 2017 / 0056169, U.S. Patent Application Publication No. 2016 / 0317301, and U.S. Patent Application Publication No. 2017 / 0056171, the entirety of each of which patents and patent application publications are incorporated herein by reference. In such embodiments, tabs 104 may be advantageously omitted so as to extend to the axial dimension between the upper and lower ends of inner frame 120 (i.e., the “height” of inner frame 120).

[0095] The inner frame 120 and other frames described herein may include features and concepts similar to those disclosed in U.S. Patent No. 8,403,983, U.S. Patent No. 8,414,644, U.S. Patent No. 8,652,203, U.S. Patent Application Publication No. 2011 / 0313515, U.S. Patent Application Publication No. 2014 / 0277390, U.S. Patent Application Publication No. 2014 / 0277427, U.S. Patent Application Publication No. 2014 / 0277422, U.S. Patent Application Publication No. 2015 / 0328000, U.S. Patent Application Publication No. 2018 / 0021129, and U.S. Patent Application Publication No. 2018 / 0055629. Each of these patents and patent application publications is incorporated by reference in its entirety and made a part of this specification, which encompasses the entire disclosure, but is not limited to the disclosure of the associated frame. Additionally, while the inner frame 120 has been described as including the inner frame body 122 and the inner frame anchoring feature 124, it should be understood that the inner frame 120 need not include all of the components. For example, in some embodiments, the inner frame 120 can include the inner frame body 122 while omitting the inner frame anchoring feature 124. Additionally, while the inner frame body 122 and the inner frame anchoring feature 124 have been shown as being integrally or unitarily formed, it should be understood that in some embodiments, the inner frame body 122 and the inner frame anchoring feature 124 can be formed separately. In such embodiments, these separate components can be attached using any of the fasteners and / or techniques described herein. For example, the inner frame anchoring feature 124 can be formed separately from the inner frame body 122 and attached to it.

[0096] 5A-5E illustrate an inner frame 220 having an "hourglass" or approximately hourglass shape. A multi-portion replacement valve having an hourglass-shaped inner frame is generally shown in connection with FIGS. 30A-30D. The inner frame 220 can incorporate any or all of the features discussed above in connection with the inner frame 120, such as the frame anchoring feature 124, and the inner frame 120 can incorporate any or all of the features discussed above in connection with the inner frame 220. The inner frame 220 can include an upper region 226, a middle region 228, and a lower region 230. As shown, the middle region 228 can have a smaller diameter than the upper region 226, the lower region 230, or both. This can form an hourglass shape in which the middle region 228 has a narrower diameter than both the upper region 226 and the lower region 230. In some embodiments, the upper region 226 and the lower region 230 can have approximately the same diameter. In some embodiments, the upper region 226 can have a larger diameter than the lower region 230. In some embodiments, the upper region 226 can have a smaller diameter than the lower region 230.

[0097] 5A-5E further illustrate that the inner frame 220 can form a curved shape by smoothly transitioning between different diameters. In some embodiments, the struts that make up the inner frame 220 can be curved to form an hourglass shape. In some embodiments, the struts can be relatively straight, with inflection points in the struts or at the junctions between struts. In some embodiments, the inner frame 220 can be concave. In some embodiments, a portion of the inner frame 220, such as the upper region 226, middle region 228, and / or lower region 230, can be concave. In some embodiments, the inner frame 220 can be curved inward or narrower at the middle portion than at the top and bottom. In some embodiments, the inner frame 220 can form an hourglass shape in its fully expanded configuration. In some embodiments, the hourglass shape may be configured from a linear radially inward taper from upper region 226 to middle region 228 (so that the diameter is smaller in middle region 228 than in upper region 226), and then a radially outward taper (e.g., an inverse of the taper described above) from middle region 228 to lower region 230 (so that the diameter is smaller in middle region 228 than in lower region 230). In some embodiments, frame 220 may have a tapered waist or a narrow waist.

[0098] In some embodiments, the inner frame 220 may taper radially inward (e.g., reduce in diameter) in one direction from one end to the other. For example, the upper region 226 may have the largest diameter, and the inner frame 220 may taper radially inward to the middle region 228 and further taper radially inward to the lower region 230. In some embodiments, the lower region 230 may have the largest diameter, and the inner frame 220 may taper radially inward to the middle region 228 and further taper radially inward to the upper region 226. This taper may be smooth or may be a series of linear segments, such as steps. In some embodiments, the taper may consist of one, two, three, four, or five linear segments to reduce the diameter. In some embodiments, the taper may be curved. In some embodiments, the taper may be linear.

[0099] In some embodiments, one portion of inner frame 220 may taper radially inward, while another portion is cylindrical (or approximately cylindrical). For example, upper region 226 may taper radially inward, while middle region 228 and / or lower region 230 may be cylindrical. In some embodiments, lower region 230 may taper radially inward, while middle region 228 and / or upper region 226 may be cylindrical.

[0100] In some embodiments, one portion of inner frame 220 may taper radially inward, while another portion may be concave (or generally concave). For example, upper region 226 may taper radially inward, while middle region 228 and / or lower region 230 may be generally concave. In some embodiments, lower region 230 may taper radially inward, while middle region 228 and / or upper region 226 may be generally concave.

[0101] The hourglass shape and / or the taper described above may allow the leaflets of the valve to lie "flush" against the inner frame 220 when opened. Furthermore, the longitudinal lengths of the leaflets may abut the inner frame 220 to the greatest extent possible. For example, each of the leaflets may have an inlet end positioned along the reduced diameter portion of the frame, as discussed above. Furthermore, the narrower intermediate region 228 may allow for the use of smaller replacement leaflets, and the smaller diameter may allow for increased blood flow through this narrower area.

[0102] Advantageously, some embodiments of the inner frame 220 may reduce thrombus formation. For example, the hourglass shape aids in vortex generation, which, along with high turbulence during closure, may promote particle washout during valve opening. This may also include squeezing out thrombus that may form in the gap between the valve leaflets and the frame 220. Furthermore, this shape may reduce leaflet thickening, which can increase stroke risk. This may allow for reduced or even lifelong avoidance of blood thinners. Clinically, this may translate to reduced anticoagulation therapy, improved durability, and reduced stroke.

[0103] 5F-5I show the leaflets 231 opening within the hourglass-shaped frame 220. FIG. 5F shows the outflow end in an open state, FIG. 5G shows the inflow end in an open state, FIG. 5H shows the outflow end in a closed state, and FIG. 5I shows the inflow end in a closed state. In some embodiments, the inlet ends of the leaflets 231 may lie flat along the inner frame 220 when the valve is open. Therefore, if the inner frame 220 is a cylindrical frame, the leaflets 231 may not be parallel to the frame walls because they would necessarily be tilted outward in the open position, compressing or distorting the leaflets. However, by utilizing the above-described shape of the inner frame 220 (hourglass, tapered, concave, or similar) where the inlets of the valve leaflets 231 are located, the leaflets 231 also necessarily rest closer to the frame 220 itself and are not compressed or deformed when the valve is open, as shown in Figures 5F and 5G. Thus, the leaflets 231 conform to the shape of the hourglass-shaped frame 220 when opening, providing optimal washout. In some embodiments, the leaflets 231 may be attached at approximately the mid-region 228, so that they can extend radially outward further in the region of larger diameter when opened.

[0104] Additionally, the hourglass-shaped inner frame 220 may allow the leaflets of the valve body to conform to and / or contact the inner surface of the hourglass-shaped inner frame 220. Thus, the hourglass-shaped design may improve washout by reducing the gap between the seam line of the leaflets and the wall of the inner frame 220 to which the leaflets are attached. Specifically, FIG. 5J shows the leaflets 262 in a closed position, and FIG. 5K shows the leaflets 262 in a fully open position, where they generally conform to the shape of the inner frame 220. Thus, as shown, in some embodiments, the only portion of each leaflet 262 that does not contact the frame 220 when opened is the free edge of the leaflet 262 located at the outlet end. Thus, substantially the entire “belly” or “surface” of each leaflet 262 (e.g., the surface of leaflet 262 facing the inner surface of inner frame 220) conforms to and / or contacts the hourglass-shaped inner frame 220 (e.g., reducing the gap between leaflet 262 and the inner surface of inner frame 220). In some embodiments, more than 50%, more than 75%, more than 90%, more than 95%, or more than 99% of the leaflet 262 belly may conform to and contact the inner surface of the inner frame 220 when in the fully open position. In some embodiments, the free edge of the outlet end of leaflet 262 does not contact inner frame 220. In some embodiments, only the free edge of the outlet end of leaflet 262 does not contact inner frame 220. In some embodiments, the free edge of the outlet end of leaflet 262 is spaced from the inner surface of inner frame 220.

[0105] This configuration can be advantageous because free edges that contact the frame can pose a major durability challenge, as constant opening and closing can wear and damage / destroy these edges. Therefore, the hourglass-shaped frame 220 is advantageously shaped to achieve optimal contact between the leaflet and frame surfaces when the leaflets 262 are fully opened, while avoiding free edge contact reduces overall damage to the leaflets during operation. This improves washout, reduces thrombogenicity, and allows for more durable leaflets.

[0106] While the hourglass and tapered shapes are described above in combination with the inner frame 220, similar dimensions / shapes may be used with the outer frame 140 or a single frame prosthesis. Furthermore, this may be applied to any type of valve, such as a replacement mitral valve or a replacement aortic valve.

[0107] FIG. 31 illustrates an alternative configuration of the hourglass shape example discussed above with respect to inner frame 220, which may include any or all of the features discussed in connection with frames 120 / 220 shown in FIGS. 2 and 5a. Rather than the hourglass shape discussed above with respect to inner frame 220, inner frame 220' can have a non-hourglass cylindrical shape, such as that shown in FIG. 2, between upper region 226', middle region 228', and lower region 230', as shown in FIG. 31. For example, inner frame 220' can have a substantially constant cross-sectional dimension, e.g., generally circular, between upper region 226', middle region 228', and lower region 230'. An additional secondary inner frame 502 can then be mounted (permanently or removably) on the inner surface of inner frame 220'. Secondary inner frame 502 can have a generally circular cross-section.

[0108] The secondary inner frame 502 can be shaped to form an hourglass shape within the lumen of the inner frame 220'. For example, the middle region 228' can have a smaller radial diameter than the upper and lower regions 226', 230'. In some embodiments, the upper and lower regions 226', 230' can have approximately the same dimensions. In other embodiments, these diameters can be different. In some embodiments, the transition between the different diameters can be smooth, such as having a curve, or can be angled with distinct corners. The secondary inner frame 502 can have a concave shape.

[0109] As shown in FIG. 31, the secondary inner frame 502 can be mounted at approximately the proximal end (e.g., in the upper region 226') and approximately the distal end (e.g., in the lower region 230') of the secondary inner frame 502, and the central portion of the secondary inner frame 502 can be located radially inward from these ends and from the inner surface of the inner frame 220'.

[0110] In some embodiments, a proximal portion of the secondary inner frame 502 may be attached to the inner frame 220' proximal to where the tabs 104 originate. In some embodiments, a proximal portion of the secondary inner frame 502 may be attached to the inner frame 220' distal to where the tabs 104 originate. In some embodiments, a proximal portion of the secondary inner frame 502 may be attached to the inner frame 220' at where the tabs 104 originate.

[0111] In some embodiments, a distal portion of the secondary inner frame 502 may be attached to the inner frame 220' proximal to where the inner frame anchoring features 124 originate and bend radially outward. In some embodiments, a distal portion of the secondary inner frame 502 may be attached to the inner frame 220' distal to where the inner frame anchoring features 124 originate and bend radially outward. In some embodiments, a distal portion of the secondary inner frame 502 may be attached to the inner frame 220' distal to where the inner frame anchoring features 124 originate and bend radially outward.

[0112] The secondary inner frame 502 may be attached to the inner frame 220', for example, by sutures, adhesive, friction, mechanical attachment, etc., or the two frames may be integrally formed together.

[0113] The secondary inner frame 502 can be a "super thin-walled" inner frame, such as between 200 and 400 microns thick, although this particular size is not limiting. For example, the secondary inner frame 502 can be formed from multiple longitudinal strips (e.g., ribs), such as metal, composite, or polymer strips. These strips can flex inward as the inner frame 220' foreshortens during radial expansion. In some embodiments, the strips can always flex inward. In some embodiments, the strips can be used in combination with a fabric or polymer. Thus, the secondary inner frame 502 can generally be a fabric tube with multiple ribs on the exterior of the fabric, which push the fabric inward to form an hourglass shape. Alternatively, a thin braided mesh that can flex inward, such as when foreshortened, can be used in combination with the fabric discussed above.

[0114] In some embodiments, fabric or other fabric can be used to form the hourglass shape. For example, the fabric can act as a pocket that fills with blood and hardens over time into a particular hourglass shape. Alternatively, a balloon can be used to form the hourglass shape, and the balloon can be filled with saline or other biocompatible fluid.

[0115] In some embodiments, a swellable material may be used to form the secondary inner frame 502. This swellable material may absorb water or other fluids from the blood and swell to a desired shape.

[0116] The secondary inner frame 502 can be advantageous because it enhances the highly stable cylindrical inner frame design of the inner frame 220' while still providing the anti-thrombotic benefits of the hourglass shaped secondary inner frame 502.

[0117] Outer frame Reference is now made to the outer frame 140, shown alone in FIGS. 6A-6D . The outer frame 140 may be incorporated into a prosthesis along with any of the inner frame variations described. The outer frame 140 may provide a structure to which the various components of the prosthesis 100 may be attached. The outer frame 140 may be attached to the inner frame 120 utilizing any of the fasteners and / or techniques described herein, including, but not limited to, mechanical fasteners such as sutures, staples, threads, rivets, joining members (e.g., tabs and slots that may be located on the inner frame 120 and outer frame 140), and any other type of mechanical fasteners as desired; chemical fasteners such as adhesives and any other type of chemical fasteners as desired; fastening techniques such as welding, soldering, sintering, and any other type of fastening technique as desired; and / or combinations of such fasteners and techniques. In some embodiments, the inner frame 120 and outer frame 140 may be attached indirectly via an intermediate component, such as a skirt 180. In some embodiments, sutures may be used to attach the eyelets 143 of the outer frame 140 to the eyelets 106 of the inner frame 120 .

[0118] The outer frame 140 may be attached to the inner frame 120 at one or more attachment points. The outer frame 140 may be tightly attached to the inner frame 120 such that there is little or no relative movement between the outer frame 140 and the inner frame 120 at one or more attachment points. In other embodiments, the outer frame 140 may be loosely attached to the inner frame 120 such that there may be some relative movement between the outer frame 140 and the inner frame 120 at one or more attachment points. Although the outer frame 140 is illustrated as a separate component from the inner frame 120, it should be understood that the frames 120, 140 may be integrally or unitarily formed.

[0119] As shown in the illustrated embodiment, the outer frame 140 may include an outer frame body 142. In some embodiments, such as that shown in Figure 12, the outer frame 140 may further include an outer frame anchoring feature 144 (also known as an atrial anchor or proximal anchor when used in the mitral valve). However, as shown in Figures 6A-6D (and Figures 9-11), the outer frame need not include an outer frame anchoring feature 144.

[0120] The outer frame body 142 may have an upper region 146, a middle region 148, and a lower region 150. In some situations, such as when the prosthesis 100 is positioned within a native mitral valve, the upper region 146 may be positioned generally above the annulus, the middle region 148 may be positioned generally within the annulus, and the lower region 150 may be positioned below the annulus. However, it should be understood that in some situations, the positioning of the outer frame 140 relative to the annulus may differ. Furthermore, it should be understood that in some embodiments, the outer frame 140 may omit one or more of the upper region 146, the middle region 148, and / or the lower region 150.

[0121] When in an expanded configuration, such as a fully expanded configuration, the outer frame body 142 can have an enlarged / bulbal shape in which the middle region 148 and the lower region 150 are larger than the upper region 146, or the middle region 148 is larger than the lower region 150 and the upper region 146. Advantageously, the bulbous shape of the outer frame body 142 can enable the outer frame body 142 to engage the native valve annulus, native valve leaflets, or other body cavity while spacing the inlets and outlets from the heart or blood vessel wall. This can help reduce undesirable contact between the prosthesis 100 and the heart or blood vessel, such as the atrial and ventricular walls of the heart. The bulbous shape can further enhance fixation of the outer frame body 142 to the body cavity. For example, in some embodiments, the bulbous shape can enable the middle region 148 to extend further radially outward when compared to the anchoring features. In this way, the intermediate region 148 can apply a higher radial force to the tissue of the body cavity and / or can conform more completely to the tissue of the body cavity, such as the native valve annulus and / or native valve leaflets.

[0122] The upper region 146 of the outer frame body 142 can include a generally longitudinally extending section 146a and an outwardly extending section 146b. The longitudinally extending section 146a can be generally concentric with the inner frame body 122. The outwardly extending section 146b can extend radially outward away from the longitudinal axis 102 of the prosthesis 100. The outwardly extending section 146b can extend in a direction closer to perpendicular to the longitudinal axis 102 than parallel to it and / or downwardly from the longitudinally extending section 146a. However, it should be understood that the outwardly extending section 146b can extend generally perpendicular to the longitudinal axis 102 and / or upwardly from the longitudinally extending section 146a. Furthermore, it should be understood that the longitudinally extending section 146a can be omitted such that the upper region 146 extends radially outward at an upper end of the upper region 146.

[0123] At the junction between the longitudinally extending section 146a and the outwardly extending section 146b, the outer frame body 142 may include a bend 152. The bend 152 may be about a circumferential axis such that the outwardly extending section 146b extends in a direction that is more perpendicular to the longitudinal axis of the outer frame 140 than the longitudinally extending section 146a. In some embodiments, the bend 152 may generally form an arc having an angle between about 20 degrees and about 90 degrees. For example, as shown in the illustrated embodiment, the arc may have an angle of about 60 degrees. In some embodiments, the bend 152 may form an arc having an angle between about 30 degrees and about 60 degrees. The radius of curvature of the arc may be constant so that the bend 152 forms an arc, or may vary along the length of the bend 152.

[0124] In some embodiments, outwardly extending section 146b can form an angle between about 20 degrees and about 70 degrees with a plane perpendicular to the longitudinal axis of prosthesis 100, an angle between about 30 degrees and about 60 degrees with a plane perpendicular to the longitudinal axis of prosthesis 100, an angle between about 40 degrees and about 50 degrees with a plane perpendicular to the longitudinal axis of prosthesis 100, an angle of about 45 degrees with a plane perpendicular to the longitudinal axis of prosthesis 100, any subrange within these ranges, or any other angle as desired. In some embodiments, the outwardly extending section 146b can form an angle of less than 70 degrees with a plane perpendicular to the longitudinal axis of the prosthesis 100, an angle of less than 55 degrees with a plane perpendicular to the longitudinal axis of the prosthesis 100, an angle of less than 40 degrees with a plane perpendicular to the longitudinal axis of the prosthesis 100, an angle of less than 25 degrees with a plane perpendicular to the longitudinal axis of the prosthesis 100, or any other angle as desired.

[0125] The intermediate region 148 of the outer frame body 142 may extend generally downward from the outwardly extending section 146b of the upper region 146. As shown, the intermediate region 148 may have a generally constant diameter from the upper end of the intermediate region 148 to the lower end of the intermediate region 148, such that the intermediate region 148 forms a generally cylindrical shape. However, it should be understood that the diameters of the upper end, the lower end, and / or the portion between the upper and lower ends may be different. For example, the diameter of the portion between the upper and lower ends may be larger than the upper and lower ends, such that the intermediate region 148 has a generally bulbous shape. In some embodiments, the diameter of the lower end may be larger than the diameter of the upper end. In other embodiments, the diameter of the upper end may be larger than the diameter of the lower end. Additionally, although the outer frame body 142 has been described and illustrated as being cylindrical or having a circular cross-section, it should be understood that all or a portion of the outer frame body 142 may have a non-circular cross-section, such as, but not limited to, a D-shape, elliptical, or other oval cross-sectional shape.

[0126] In some embodiments, lower region 150 can be curved and / or angled toward the longitudinal axis of the frame such that the lower end of lower region 150 can extend in a direction that is between about 20 degrees and about 80 degrees relative to a plane parallel to the longitudinal axis, between about 25 degrees and about 70 degrees relative to a plane parallel to the longitudinal axis, between about 30 degrees and about 60 degrees relative to a plane parallel to the longitudinal axis, or at about 30 degrees relative to a plane parallel to the longitudinal axis. Lower region 150 can be curved and / or angled toward the longitudinal axis such that the lower end of lower region 150 can extend in a direction that is approximately perpendicular to the longitudinal axis.

[0127] In some embodiments, the outer frame body 142 in the expanded configuration can have a diameter at its widest portion between about 30 mm and about 60 mm, between about 35 mm and about 55 mm, about 40 mm, any subrange within these ranges, or any other diameter as desired. In some embodiments, the outer frame body 142 in the expanded configuration can have a diameter at its narrowest portion between about 20 mm and about 40 mm, any subrange within these ranges, or any other diameter as desired. In some embodiments, the outer frame body 142 in the expanded configuration can have a diameter at the lower end of the lower region 150 between about 20 mm and about 40 mm, any subrange within these ranges, or any other diameter as desired. In some embodiments, in the expanded configuration, the ratio of the diameter of the outer frame body 142 at its widest portion to the diameter of the frame body 142 at its narrowest portion can be about 3:1, about 5:2, about 2:1, about 3:2, about 4:3, any ratio within these ratios, or any other ratio as desired.

[0128] The outer frame body 142 can have an axially compact configuration relative to its radial dimension. In the expanded configuration, the outer frame body 142 can have an axial dimension between the upper and lower ends of the outer frame body 142 (i.e., the "height" of the outer frame body 142) of between about 10 mm and about 40 mm, between about 18 mm and about 30 mm, about 20 mm, any subrange within these ranges, or any other height as desired. In some embodiments, the ratio of the diameter of the largest portion of the outer frame body 142 to the height of the outer frame body 142 when the frame is in the expanded configuration can be about 3:1, about 5:2, about 2:1, about 3:2, about 4:3, about 13:10, about 5:4, or about 1:1. Thus, in some embodiments, the width of the outer frame body 142 at its largest portion can be greater than the height of the outer frame body 142.

[0129] 6A-6D, the outer frame body 142 includes a plurality of struts, at least some of which may form cells 154. Any number of strut configurations may be used, such as the illustrated rings of undulating struts that form oval, elliptical, rounded polygonal, and teardrop shapes, but also chevron, diamond, curved, and various other shapes.

[0130] The cells 154 can have an irregular octagonal shape, such as a "teardrop" shape. The cells 154 can be formed by a combination of struts. As shown in the illustrated embodiment, the upper portion of the cell 154 can be formed from a set of circumferentially expandable struts 156a having a zigzag or wavy shape that form a repeating "V" shape. The circumferentially expandable struts 156a can be angled or curved radially outward away from the longitudinal axis of the prosthesis 100 such that the upper portions of the struts 156a are positioned closer to the longitudinal axis of the prosthesis 100 than the lower portions of the struts 156a. The bottom portion of the cell 154 can be formed from a set of struts 156b that extend downward from a center or near-center position of each of the "V" shapes. The struts 156b can extend along a plane parallel to and / or through the longitudinal axis of the prosthesis 100.

[0131] Although struts 156 are generally described and illustrated as being straight segments, it should be understood that some or all of struts 156 may not form completely straight segments. For example, struts 156 may have some curvature such that the upper and / or lower extremities are curved.

[0132] This shape of the cells 154 may allow the cells 154 to shorten as the outer frame 140 expands. In this manner, one or more of the cells 154 may allow the outer frame 140 to shorten as the outer frame 140 expands. The shortening of the outer frame 140 may be used to secure the prosthesis against intraluminal tissue in a body cavity, such as tissue located at or adjacent to a native valve, including, but not limited to, the native annulus and / or native leaflets. For example, the expansion of the outer frame 140 may allow the outer frame 140 to apply a radially outward force against tissue located at or adjacent to a native valve, such as the native annulus and / or native leaflets.

[0133] 7A-7B show the flat pattern of the outer frame 140 in the compressed position (FIG. 7A) and the expanded position (FIG. 7B). As shown, the struts 156b are generally circumferentially held between the struts 156a in both the compressed and expanded positions. Furthermore, in some embodiments, the struts 156a / 156b can be asymmetric, such that some struts are less compressible / expandable than others. Specifically, the struts 156b can have a different width / thickness than the struts 156a. While symmetric cells can have uneven expansion and crimping, the asymmetric cells disclosed herein can have uniform expansion and crimping. Furthermore, having different widths / thicknesses can promote valve stability. Because larger struts can be subject to retention by the delivery system, these struts can be stronger, having a greater impact than thinner struts when the delivery system crimps the prosthesis 100. However, in some embodiments, struts 156a / 156b are of the same thickness / width (eg, symmetrical).

[0134] In some embodiments, struts 156b can be 100%, 95%, 90%, 80%, 70%, 60%, 50%, 40%, or 30% of the thickness / width of struts 156a. In some embodiments, struts 156b can be less than 100%, 95%, 90%, 80%, 70%, 60%, 50%, 40%, or 30% of the thickness / width of struts 156a. In some embodiments, struts 156b can be more than 95%, 90%, 80%, 70%, 60%, 50%, 40%, or 30% of the thickness / width of struts 156a.

[0135] 7C-7D show another embodiment of the flat pattern of the outer frame 140, which can include any or all of the features discussed above with respect to FIGS. 7A-7B. The features disclosed with respect to FIGS. 7C-7D can be used in combination with or in place of any of the outer frame features discussed herein. Advantageously, the outer frame 140 can include notches 151 extending partially into the struts 156a' at the junctions between the struts 156a' / 156b'. The notches can be rounded, as shown in FIG. 7D, or can have a triangular, square, or other notch pattern; the particular shape of the notches is non-limiting. The notches 151 can reduce material by approximately 0.25 mm per strut, allowing for a total reduction of 4.55 mm in the circumferential direction compared to a non-notched configuration. Additionally, this design may reduce the overall straightness of the outer frame 140 because the peak forces are generally located at the juncture of the struts 156a' / 156b'.

[0136] The outer frame 140 may also include tabs 145 extending proximally away from the eyelets 143, such as those further shown in Figures 8A-8B below. This may allow for better attachment between the outer and inner frames by allowing a second aperture per strut and a larger area for attachment of the sutures, and may provide an alternative attachment mechanism. Thus, the tabs 145 may be, for example, mushroom-shaped tabs as disclosed herein with respect to the inner frame 120, and may allow attachment into a delivery system.

[0137] Figures 8A-8B show alternative flat patterns of outer frame 140, which may include any or all of the features disclosed above with respect to Figures 7A-7D. In particular, Figure 8A shows outer frame 140 having outer frame anchoring features 144, an expanded version of which is shown in Figure 12. Additionally, both Figures 8A and 8B include upwardly extending tabs 145.

[0138] In embodiments including outer frame anchoring features 144, such as that shown in FIG. 12 , the outer frame anchoring features 144 may extend outward relative to the longitudinal axis 102 of the prosthesis 100. The outer frame anchoring features 144 may extend at or near the junction between the upper region 146 and the middle region 148 of the outer frame body 142. The outer frame anchoring features 144 can extend in a direction closer to perpendicular to the longitudinal axis 102 than parallel to it and / or may extend downward from the longitudinally extending section 146 a. The outer frame anchoring features 144 may extend in a direction generally aligned with the outwardly extending section 146 b of the upper region 146. However, it should be understood that the outer frame anchoring features 144 may extend generally perpendicular to the longitudinal axis 102 and / or upward.

[0139] In some embodiments, outer frame anchoring features 144 may extend in a direction closer to perpendicular to the longitudinal axis of prosthesis 100 than parallel to it. As shown, outer frame anchoring features 144 may extend in a downward direction that is generally parallel to outwardly extending section 146b. In some embodiments, outer frame anchoring features 144 may extend generally perpendicular and / or upward to longitudinal axis 102.

[0140] As shown in the illustrated embodiment, the outer frame 140 may include tabs 118 extending from a portion of the outer frame 140, such as the upper end of the outer frame 140. The tabs 118 may include eyelets 143. The tabs 118 may be advantageously used to couple the outer frame 140 to the inner frame 120 of the prosthesis. For example, sutures may be threaded through the eyelets 143 for coupling to the inner frame 120. In some embodiments, the tabs 118 may be used to couple to other components of the prosthesis in which the outer frame 140 is used, such as, but not limited to, the valve body and / or skirt.

[0141] In some embodiments, the tabs 118 are advantageous because they can be used to couple the outer frame 140 to multiple types of delivery systems. For example, the shape of the tabs 118 can be used to secure the outer frame 140 to a "slot"-based delivery system. The eyelets 106 can be used to secure the outer frame 140 to a "tether"-based delivery system, such as those that use sutures, wires, or fingers to control the delivery of the outer frame 140 and prosthesis. This advantageously facilitates in-situ recapture and repositioning of the outer frame 140 and prosthesis. In some embodiments, the outer frame 140 and prosthesis can be used with the delivery systems described herein, including, but not limited to, those described in U.S. Pat. No. 8,414,644, U.S. Pat. No. 8,652,203, and U.S. Patent Application Publication No. 2015 / 0238315, each of which is incorporated herein by reference in its entirety. In some embodiments, tabs may be positioned at the ends of the struts similar to locking tabs 232 .

[0142] Although anchoring features 124, 144 are discussed below, it will be understood that prosthesis 100 need not include feature 144. One or both of anchoring features 124, 144 (if used) may contact or engage a native valve annulus, such as the native mitral valve annulus, tissue beyond the native annulus, the native valve leaflets, and / or other tissue at or around the implantation location during one or more phases of the cardiac cycle, such as systole and / or diastole. In some embodiments, one or both of anchoring features 124, 144 (if used) do not contact or engage, or only partially contact or engage, a native valve annulus, such as the native mitral valve annulus, tissue beyond the native annulus, the native valve leaflets, and / or other tissue at or around the implantation location during one or more phases of the cardiac cycle, such as systole and / or diastole. However, it should be understood that in some embodiments, when the prosthesis 100 is used for a replacement mitral valve prosthesis during diastole and / or systole, both the inner frame anchoring feature 124 and the outer frame anchoring feature 144 (if used) may be sized to contact or engage the native mitral valve annulus.

[0143] Preferably, anchoring features 124, 144 (if used) and anchor tips 124 a, 144 a (if used) are positioned along prosthesis 100 with at least a portion of the shortened portion positioned between anchoring features 124, 144 (if used) such that portions of anchoring features 124, 144 (if used) move closer together upon expansion of prosthesis 100. This allows anchoring features 124, 144 (if used) to approach both sides of the native mitral valve annulus, thereby securing the prosthesis to the mitral valve. In some embodiments, anchoring features 124, 144 (if used) can be positioned so that anchoring features 124, 144 (if used) do not simultaneously contact opposite portions of the native mitral valve. For example, when prosthesis 100 is used for a replacement mitral valve prosthesis, at least during systole, in some embodiments, inner frame anchoring features 124 are sized to contact or engage the native mitral valve annulus, while outer frame anchoring features 144 (if used) are sized to be spaced apart from the native mitral valve annulus. This can be advantageous when outer frame anchoring features 144 (if used) are used to provide stabilization and aid in alignment of the prosthesis. In some embodiments, anchoring features 124, 144 (if used) can be positioned such that anchoring features 124, 144 (if used) grip opposite sides of the native mitral valve annulus.

[0144] Although anchoring features 124, 144 (if used) are shown as extending from the lower end of the lower region 130 of the inner frame body 122 and at the junction between the upper region 146 and the middle region 148 of the outer frame body 142, respectively, it should be understood that anchoring features 124, 144 (if used) may be positioned along any other portion of the prosthesis 100 as desired. Additionally, while two anchoring features 124, 144 (if used) are included in the illustrated embodiment, it should be understood that more or fewer sets of anchoring features may be used.

[0145] Components of the outer frame 140, such as the outer frame body 142, can be used to mount or secure the prosthesis 100 to a native valve, such as a native mitral valve. For example, the intermediate region 148 and / or the outer anchoring features 144 of the outer frame body 142 can be positioned to contact or engage the native annulus, tissue beyond the native annulus, the native valve leaflets, and / or other tissue at or around the implantation location during one or more phases of the cardiac cycle, such as systole and / or diastole. In situations where the outer frame body 142 is positioned within the native mitral valve, the outer frame body 142 can advantageously eliminate, prevent, or limit downward forces, such as those applied to the prosthesis 100 during diastole, and / or upward forces, such as those applied to the prosthesis 100 during systole. As another example, the outer frame body 142 can be sized and positioned relative to the inner frame anchoring feature 124 so that tissue of the body cavity positioned between the outer frame body 142 and the inner frame anchoring feature 124, such as the native valve leaflets and / or annulus, can be engaged or pinched to further secure the prosthesis 100 to the tissue. For example, the lower region 150 of the outer frame body 142 can be positioned at or near the tip or end of the inner frame anchoring feature 124. As shown, the lower region 150 of the outer frame body 142 is positioned so that at least a portion is positioned radially inward and below the inner frame anchoring feature 124. In some embodiments, a portion of the outer frame 140, such as the lower region 150, can be attached to the inner frame body 122 with one or more tethers or sutures to limit the outward extension of the outer frame 140 relative to the inner frame body 122. This may advantageously maintain a portion of the outer frame 140 between the inner frame body 122 and the inner frame anchoring feature 124. Although the inner frame anchoring feature 124 is shown as extending from the inner frame body 122, it should be understood that such anchoring feature may extend from the outer frame body 142.

[0146] The use of an inner frame 120 and an outer frame 140 can be advantageous for prosthesis design, as the inner frame 120 can be designed to suit the structure of the valve body 160 and the outer frame 140 can be designed to suit the anatomy of the body cavity within which the prosthesis 100 will be used. For example, the valve body 160 (shown in FIG. 10 ) can be cylindrical and have a smaller diameter than the body cavity. In such embodiments, the inner frame 120 can advantageously have a smaller shape and / or size to support the valve body 160, while the outer frame 140 can have a larger shape and / or size to secure the prosthesis 100 to the body cavity. Furthermore, in embodiments in which the outer frame 140 is larger than the inner frame 120, the shape of the outer frame 140 can advantageously enhance hemodynamic performance. For example, a shape of the outer frame 140 with a larger, generally cylindrical intermediate region 148 can allow for significant washout of the underside of the valve body 160. Advantageously, this flushing may reduce the risk of thrombus or clot formation beneath and around the valve body 160 .

[0147] The outer frame 140 can be formed from a number of different materials, including, but not limited to, shape memory metals such as Nitinol. The outer frame 140 can be formed from a plurality of struts forming open cells. In some embodiments, the outer frame 140 can have a more flexible structure compared to other components of the prosthesis 100, including, but not limited to, the inner frame 120. This can be achieved, for example, by the size and configuration of the struts. For example, fewer struts, thinner struts, and / or different materials can be used for the struts. This more flexible structure allows the outer frame 140 to better conform to the anatomical structures of the body cavity, such as the native annulus and / or leaflets. This can be advantageous for anchoring to and / or forming a seal with the body cavity. However, it should be understood that in some embodiments, the outer frame 140 can have a structure that is approximately the same as or more rigid than other components of the prosthesis 100, such as the inner frame 120.

[0148] The outer frame 140 and any other frames described herein may include features and concepts similar to those disclosed in U.S. Patent No. 8,403,983, U.S. Patent No. 8,414,644, U.S. Patent No. 8,652,203, U.S. Patent Application Publication No. 2011 / 0313515, U.S. Patent Application Publication No. 2014 / 0277390, U.S. Patent Application Publication No. 2014 / 0277427, U.S. Patent Application Publication No. 2014 / 0277422, U.S. Patent Application Publication No. 2018 / 0021129, U.S. Patent Application Publication No. 2018 / 0055629, and U.S. Patent Application Publication No. 2015 / 0328000, the entirety of which are incorporated herein by reference. Additionally, while the outer frame 140 has been described as including the outer frame body 142 and the outer frame anchoring features 144, it should be understood that the outer frame 140 need not include all of the components. For example, in some embodiments, the outer frame 140 can include the outer frame body 142 while omitting the outer frame anchoring features 144. Additionally, while the outer frame body 142 and the outer frame anchoring features 144 have been illustrated as being integrally or unitarily formed, it should be understood that in some embodiments, the outer frame body 142 and the outer frame anchoring features 144 can be formed separately. In such embodiments, the separate components can be attached using any of the fasteners and techniques described herein. For example, the outer frame anchoring features 144 can be formed separately from the outer frame body 142 and attached to it.

[0149] skirt 9-11 show the prosthesis 100 with a skirt 180. The skirt 180 may be attached to the inner frame 120 and / or the outer frame 140 (or any of the alternative frames disclosed herein). As shown, the skirt 180 may be positioned and secured around a portion or all of the exterior of the inner frame 120 and / or the outer frame 140, such as between the two frames 120 / 140. The skirt 180 may also be secured to a portion of the valve body 160. The skirt 180 may follow the contours of the outer frame 140, such as the contours of the upper region 146, the middle region 148, and / or the lower region 150. In some embodiments, the skirt 180 may be used to attach the outer frame 140 to the inner frame 120. While not shown, it should be understood that the skirt 180 may be positioned and secured around a portion or all of the interior of the inner frame 120 and / or the outer frame 140. It should further be understood that the skirt 180 may follow the contours of portions of the inner frame 120 and the outer frame 140, and that at least a portion of the skirt 180 may be spaced apart from at least a portion of both the inner frame 120 and the outer frame 140. In some embodiments, the skirt 180 may be spaced apart from the upper region 146 of the outer frame 140. For example, the skirt 180 may be positioned below the upper region 146. In such embodiments, the spaced apart portion of the skirt 180 may be loose, allowing the skirt 180 to move relative to the upper region 146, or may be tight, allowing the skirt 180 to be generally fixed in place. The skirt 180

[0150] The skirt 180 can be annular and may extend completely circumferentially around the inner frame 120 and / or outer frame 140. The skirt 180 may prevent or inhibit the backflow of fluids, such as blood, around the prosthesis 100. For example, with the skirt 180 annularly disposed around the exterior of the inner frame 120 and / or outer frame 140, the skirt 180 may form an axial barrier to fluid flow outside the inner frame 120 and / or outer frame 140 when deployed in a body cavity, such as a natural valve annulus. The skirt 180 may promote tissue ingrowth between the skirt 180 and the natural tissue of the body cavity. This may further help prevent blood leakage around the prosthesis 100 and may allow for further fixation of the prosthesis 100 to the body cavity. In some embodiments, the skirt 180 may be tightly attached to the inner frame 120 and / or the outer frame 140 such that the skirt 180 is generally not movable relative to the inner frame 120 and / or the outer frame 140. In some embodiments, the skirt 180 may be loosely attached to the inner frame 120 and / or the outer frame 140 such that the skirt 180 is movable relative to the inner frame 120 and / or the outer frame 140.

[0151] In some embodiments, skirt 180 may be formed from a material such as knitted polyester (e.g., polyethylene terephthalate (PET), polyvalerolactone (PVL)), or any other biocompatible material, such as one that is completely or substantially fluid permeable, flexible, stretchable, deformable, and / or elastic. Skirt 180 and / or liner may be made from the same or similar materials. As shown in the illustrated embodiment, skirt 180 may be formed as separate components. These components may be attached together utilizing any of the fasteners and / or techniques described herein, including, but not limited to, mechanical fasteners such as sutures, staples, screws, rivets, joining members (e.g., tabs and slots), and any other type of mechanical fasteners as desired; chemical fasteners such as adhesives and any other type of chemical fasteners as desired; fastening techniques such as welding, soldering, sintering, and any other type of fastening technique as desired; and / or combinations of such fasteners and techniques.

[0152] In some embodiments, the skirt 180 may be attached to the inner frame 120, such as at one of the struts. For example, the skirt 180 may be attached to the longitudinally extending strut 138 or the circumferentially extending struts 136a / 136b. The skirt 180 may be attached by, but is not limited to, sutures, adhesive, tying, etc. In some embodiments, the skirt 180 may also be attached to the outer frame 140.

[0153] By attaching the skirt 180 to the inner frame 120, when the prosthesis 100 first begins to crimp for traction / retrieval, etc., the skirt 180 is pulled inward along with the inner frame 120. Thus, the skirt 180 can be tucked between the struts of the outer frame 140. In some embodiments, this automatic tacking can be advantageous because a large amount of material (e.g., fabric) for the outer skirt 180 is required to seal particularly large annuli. Therefore, the skirt 180 may interfere with / hinder low-profile crimping by “stuck” the struts and preventing closure, or may require a large amount of force to fully crimp the prosthesis. Therefore, manual tacking can be avoided and retrieval forces can be eliminated. FIGS. 13A-13B illustrate the automatic tacking of fabric into the prosthesis 100.

[0154] As shown in FIG. 9 , the ventricular portion (e.g., bottom, distal, or lower portion) of the skirt 180 (e.g., a fabric skirt) can function as a “curtain” around the inner frame 220. For example, the ventricular portion 182 of the outer skirt 180 is not attached to the outer frame 140 because the outer frame 140 terminates above this portion of the skirt 180. Also, this portion 182 is not attached to the inner frame 220 until the bottom of the skirt 180. Thus, portion 182 of the outer skirt 180 is not circumferentially attached, but instead is held in a generally tensioned state between the inner surface of the outer frame 140 and the outer surface of the ventricular or distal end of the inner frame 220. This allows the outer skirt 180 to flex or bend when radial pressure is applied. Thus, outer skirt 180 is flexible to conform to a valve annulus, such as the mitral annulus, which may provide an improved seal between prosthesis 100 and the annulus. This may be particularly advantageous because having a curtain configuration and a reduced outer frame 140 may reduce the overall profile of the device. Furthermore, by omitting the lower portion of outer frame 140 (e.g., the portion surrounding portion 182), outer frame 140 may be more easily compressed against inner frame 220, and the entire structure may be compressed to a much smaller diameter than a device having an outer frame that extends to anchoring features 124.

[0155] 14A-14B and 15 illustrate one embodiment of a prosthesis 100 that may use an outer skirt 180 to improve the stiffness of the inner frame anchoring features 124. Specifically, the skirt 180 may be added to the prosthesis 100 to improve the stiffness of the inner frame anchoring features 124, such as by distributing forces between the inner frame 120, the outer frame 140, and added stiffness-enhancing material 192 (which may be part of the skirt 180). Thus, the stiffness-enhancing material 192 may be incorporated into the skirt 180, may be the same as the skirt 180, or may be a unique, separate material.

[0156] 14A-14B show one example embodiment of improved stiffness. As shown, the prosthesis may include an inner frame 120 having inner frame anchoring features 124, an outer frame 140, and a stiffness-improving material 192. In some embodiments, the stiffness-improving material 192 can be fabric, fiber, or other soft material such as those discussed above with respect to the skirt 180. As shown, the stiffness-improving material 192 may be attached at three different points on the prosthesis 100. The stiffness-improving material 192 may be located between the frames 120 / 140 or radially outward of both frames 120 / 140.

[0157] At one point, the stiffness-enhancing material 192 may be attached to the lower end of the outer frame 140. This stiffness-enhancing material 192 may be attached at the base tip of strut 156a or at the base tip of strut 156b. However, the stiffness-enhancing material 192 may be attached at any particular point on the outer frame 140. In some embodiments, the stiffness-enhancing material 192 may be attached to outer frame anchoring features 144, if used. This attachment can be with sutures, thread, chemical adhesives, or mechanical fasteners, and this particular attachment is not limiting.

[0158] Next, the stiffness-improving material 192 may be attached onto the inner frame anchoring feature 124. For example, the stiffness-improving material 192 may be attached approximately midway along the inner frame anchoring feature 124, such as that shown in FIGS. 14A-14B. However, the stiffness-improving material 192 can be attached at any point along the inner frame anchoring feature 124, and this particular location is not limiting. The attachment can be located approximately at the midpoint of the stiffness-improving material 192, but this is not limiting. The attachment can be a suture, thread, chemical adhesive, or mechanical fastener, and this particular attachment is not limiting.

[0159] Additionally, a second end of the stiffness-improving material 192 may be attached to a portion of the inner frame 120. For example, the second portion of the stiffness-improving material 192 may be attached to a longitudinally extending strut 138 or to a circumferentially extending strut 136b. The stiffness-improving material 192 may be attached to the first and second ends at approximately the same longitudinal location. In some embodiments, the stiffness-improving material 192 is attached to the inner frame 120 at a different longitudinal location than it is attached to the outer frame 140. In some embodiments, the stiffness-improving material 192 is attached to the inner frame 120 at a lower longitudinal location (e.g., toward the inner frame anchoring feature 124) than it is attached to the outer frame 140. In some embodiments, the stiffness-enhancing material 192 is attached to the inner frame 120 at a higher longitudinal position (e.g., away from the inner frame anchoring features 124) than it is attached to the outer frame 140. The attachment can be with sutures, thread, chemical adhesives, or mechanical fasteners, this particular attachment being non-limiting.

[0160] 14A shows the prosthesis 100 in an expanded position. As shown, the stiffness-improving material 192 is pulled taut, thereby applying an upward force to the stiffness-improving material 192 and thus the inner frame anchoring features 124. As the prosthesis 100 begins to compress, as shown in FIG. 14B, the stiffness-improving material 192 becomes slack, thus reducing the stiffness of the inner frame anchoring features 124 and facilitating retrieval.

[0161] In some embodiments, the stiffness-improving material 192 may extend along the periphery of the prosthesis 100, such as discussed above with respect to the skirt 180. In some embodiments, the stiffness-improving material 192 may extend partially around the periphery of the prosthesis 100. In some embodiments, multiple stiffness-improving materials 192 may be used. In some embodiments, a stiffness-improving material 192 is attached to each inner frame anchoring feature 124. In some embodiments, a stiffness-improving material 192 is attached to every other inner frame anchoring feature 124. In some embodiments, a stiffness-improving material 192 is attached to every third inner frame anchoring feature 124.

[0162] Additionally, the use of the stiffness-improving material 192 may form a "sealed cavity," "clot pocket," "fabric pocket," or "pocket" between the inner frame 120 and the outer frame 140. This pocket is an empty volume between the inner frame 120 and the outer frame 140 that is covered with the stiffness-improving material 192. This may mitigate thrombus formation in the prosthesis 100 because, when the prosthesis 100 is in the open configuration, blood flows through the struts in the frame and circulates between the frames, causing thrombus formation. In some embodiments, multiple holes may be present in the stiffness-improving material 192, allowing the stiffness-improving material 192 to expand, fully solidify, and remain in a permanently expanded state.

[0163] FIG. 15 illustrates an alternative stiffness-improving material 192 in which the stiffness-improving material 192 is one or more sutures. As shown, a single suture may extend around the periphery of the prosthesis 100, although in some embodiments, multiple separate sutures may be used. In this embodiment, the suture extends between the outer frame anchoring feature 144 and the circumferentially adjacent inner frame anchoring feature 124, thus forming a “zigzag” pattern around the prosthesis 100. As shown, the stiffness-improving material 192 may pass through apertures located at the ends of the outer frame anchoring feature 144. The stiffness-improving material 192 can either be tied or passed through these apertures. The stiffness-improving material 192 may then be attached to the surrounding material of the inner frame anchoring feature 124. In some embodiments, the stiffness-enhancing material 192 surrounds the inner frame anchoring feature 124 itself, such as by forming a loop in the suture or extending through an aperture or around a protrusion in the inner frame anchoring feature 124. However, in some embodiments, the outer frame anchoring feature 144 may not be used and the suture may be attached directly to the outer frame 140, such as those discussed above.

[0164] Advantageously, the use of the stiffness-improving material 192 in any of the above embodiments can prevent the outer frame 140 from crimping inside the inner frame 120. This can be achieved by achieving sufficient tension with the stiffness-improving material 192 to prevent the insert in the lower portion of the outer frame 140 from penetrating into the inner frame 120.

[0165] Although prosthesis 100 has been described as including inner frame 120, outer frame 140, valve body 160, and skirt 180, it should be understood that prosthesis 100 need not include all of the components. For example, in some embodiments, prosthesis 100 can include inner frame 120, outer frame 140, and valve body 160 while omitting skirt 180. Furthermore, while these components of prosthesis 100 have been described and illustrated as separate components, it should be understood that one or more components of prosthesis 100 can be integrally or unitarily formed. For example, in some embodiments, inner frame 120 and outer frame 140 can be integrally or unitarily formed as a single component.

[0166] Additionally, the prosthesis 100 may include only a single frame, such as only the inner frame 120, only the outer frame 140, or a combination of these two frames into a single frame. Thus, the concepts discussed above, such as the hourglass shape, strut / cell shape, etc., can be incorporated into a single-frame prosthesis.

[0167] Additionally, prosthesis 100 may apply to prostheses having more than just an inner frame 120 and an outer frame 140. Thus, the concepts discussed above, such as the hourglass shape, strut / cell shape, etc., can be incorporated into prostheses having one, two, three, four, five, or six frames.

[0168] FIG. 16 shows one embodiment of the prosthesis 100 in radial compression.

[0169] 17A-17B illustrate embodiments of prosthesis 100 with several modifications that may be used in combination with any of the implementations disclosed herein. As shown in these figures, outer frame 140 may have substantial angular transitions (e.g., bends or shoulders) between upper region 146, middle region 148, and lower region 150. In some embodiments, the bends may be 50, 60, 70, 80, 90, or 100 degrees. In some embodiments, the bends may be greater than 50, 60, 70, 80, 90, or 100 degrees. In some embodiments, the bends may be less than 50, 60, 70, 80, 90, or 100 degrees. In some embodiments, lower region 150 may have approximately the same radial diameter as middle region 148. In some embodiments, lower region 150 may have a smaller radial diameter than middle region 148. This may allow the frame to function as a “plug” or “cork” within the mitral valve annulus, for example. In some embodiments, the mitral valve annulus or other structural cardiac features may apply radially inward pressure to the prosthesis 100, causing some indentation, flexion, or compression of the middle region 148 or the lower region 150, which may allow the prosthesis 100 to achieve a tighter fit. The prosthesis 100 may have a wavy inflow section, which may help mitigate atrial protrusion and promote flow prior to ejection from the delivery system. FIG. 17B shows one embodiment of an inner frame anchoring feature 124. As shown, the distal tip may be covered with a first material 121, such as ePTFE or other plastic, and the main curved portion may be covered with a second material 123. The second material 123 may be a foam or fiber. In some embodiments, the second material 123 may be a PET-coated polyurethane foam, but this is not limiting. These two materials may be attached together, such as by stitching, shrink, friction or mechanical fastening, or may be separate.

[0170] 29 illustrates an alternative embodiment of the prosthesis 100, which may include any or all of the features described herein. As shown, the outer frame 140 may have a bulbous (or generally bulbous) shape. For example, the outer frame 140 may have a shoulder, as shown in FIG. 29.

[0171] Various iterations of the prosthesis frame disclosed above, such as but not limited to those shown in FIGS. 1, 9, 12, 17A, 21, 29, and 30A, may provide advantages to the implantation procedure. For example, as discussed below, the prosthesis 100 expands from a compressed configuration to an expanded configuration during delivery. This may occur within or around the mitral valve annulus. When the outer frame 140, including any of the variations of the outer frame 140 discussed above, is expanded, the outer frame 140 may circumferentially compress tissue on the periphery of the mitral valve annulus. This shape may provide a retention shape to prevent the prosthesis 100 from entering the left ventricle during diastole and generally stabilize the prosthesis 100 within the mitral valve annulus. Thus, in some implementations, the outer frame 140 of the prosthesis 100 may not be fully expanded but may be minimally to partially compressed within the mitral valve annulus. In other implementations, the prosthesis 100 may be fully expanded and held in the left ventricle by inner frame anchoring features and in the left atrium by bulbous portions, e.g., with shoulders, of the outer frame 140. In some implementations, after release of the prosthesis 100, the prosthesis 100 can be moved by the heart toward the left ventricle and then acts as a "cork" within the mitral valve annulus.

[0172] Valve body Referring now to the valve body 160 shown in FIG. 10 , the valve body 160 may be positioned within the inner frame 120. The valve body 160 may be a replacement heart valve including multiple leaflets 262. The leaflets 262 may include a first edge, a second edge, and tabs for attaching the leaflets 262 together at the commissures of the valve body 160. The tabs may be used to secure the leaflets 262 to the inner frame 120. The first edge may be an arcuate edge and may be generally fixed in place relative to the frame 120. The second edge may be a free-moving edge that may allow the valve body 160 to be opened and closed.

[0173] The leaflets 262 may function similarly to a native mitral valve or any other valve in the vascular system, as desired. The leaflets 262 may open in a first position and then interlock to close the valve in a second position. The leaflets 262 may be configured to function as a one-way valve, such that flow in one direction opens the valve and flow in a second direction opposite the first direction closes the valve. For example, the valve body 160 may open to allow blood flow through the valve body 160 from the upper end to the lower end. The valve body 160 may close to prevent blood flow through the valve body 160 from the lower end to the upper end. In situations where the prosthesis 100 is oriented so that the upper end is the proximal end and the lower end is the distal end, the valve body 160 is positioned such that it can open to allow blood flow through the valve body 160 in a proximal-distal direction and close to prevent blood flow in a distal-proximal direction. Valve body 160 can be configured to naturally open with the heart's beat. For example, valve body 160 can open during diastole and close during systole. Valve body 160 can replace a damaged or diseased native heart valve, such as a diseased native mitral valve.

[0174] The valve body 160 may include a liner. The liner may be used to assist fluid flow through and / or around the prosthesis 100, such as through and around the inner frame 120 and the leaflets 262. The liner surrounds at least a portion of the leaflets 262 and may be coupled to one or more of the leaflets 262. For example, one or more leaflets 262 may be attached to the liner along a first edge of the leaflets 262.

[0175] The liner can be positioned within the inner frame 120 and can form an inner wall of the prosthesis 100. For example, the liner can be positioned radially inward from the struts 136a-136c of the inner frame 120 relative to the longitudinal axis of the prosthesis 100. In this manner, the fluid path toward the leaflets 262 can be relatively smooth. It is also contemplated that the liner can be positioned at least partially along the exterior of the inner frame 120 and / or outer frame 140 such that at least a portion of the liner is radially outward from the struts of the inner frame 120 and / or outer frame 140 relative to the longitudinal axis of the prosthesis 100. The liner can be positioned along the upper or inlet side of the inner frame 120. The liner can extend from a first edge of the leaflet 262 toward the upper end of the inner frame 120. The liner may also extend below the first edge of the leaflet 262 toward the lower end of the inner frame 120. The liner may also be configured to move with the shortening portion of the inner frame 120.

[0176] In some embodiments, the liner may extend the entire length of the inner frame 120 or the inner frame body 122. In other embodiments, the liner may extend along only a portion of the length of the inner frame body 122, as shown. In some embodiments, the end of the leaflet 262 may coincide with the end of the liner. Additionally, one or more of the ends of the inner frame body 122 may coincide with the end of the liner. One end of the liner may be positioned between the upper end of the inner frame 120 and the leaflet 262. The end of the liner may extend above the upper end of the inner frame body 122 and along a portion of the locking tab. In some embodiments, the end of the liner may be positioned below the upper end of the inner frame body 122 at or near the topmost portion of the first edge or arcuate edge of the leaflet 262.

[0177] Other shapes and configurations may also be used for the valve body 160. In some embodiments, the liner extends along the length of the leaflets but is not coupled to them. In the illustrated embodiment, the liner is attached to the inner frame 120, and at least a portion of the leaflets 262, such as the first edge or the arcuate edge, is attached to the liner. Additionally, multiple portions of the leaflets 262, such as multiple portions of the first edge and / or tabs, may be attached to the inner frame 120. The liner and / or leaflets 262 may be attached to the inner frame 120 or to each other using any of the fasteners and / or techniques described herein, including, but not limited to, mechanical fasteners such as sutures, staples, screws, rivets, joining members (e.g., tabs and slots), and any other type of mechanical fasteners as desired; chemical fasteners such as adhesives and any other type of chemical fasteners as desired; fastening techniques such as welding, soldering, sintering, and any other type of fastening techniques as desired; and / or combinations of such fasteners and techniques.

[0178] The liner can be constructed in several different ways. The liner can be formed from a layer of elastic material, such as knitted polyester (e.g., polyethylene terephthalate (PET), polyvalerolactone (PVL)), or any other biocompatible material that is completely or substantially fluid-permeable, flexible, stretchable, deformable, and / or elastic. In some embodiments, the liner can be made from a material that is more flexible than the leaflet material. The upper and / or lower ends of the liner can be straight, curved, or have any other desired configuration. For example, as shown in the illustrated embodiment, the liner can have a straight edge forming the end. In other embodiments, the end can be patterned to generally match the corrugations at one end of the inner frame 120. The liner can be formed from a single piece or multiple pieces.

[0179] In another embodiment of the liner, the ends may extend beyond the inner frame 120 and be wrapped around the inner frame 120. Thus, the liner may extend from the interior of the inner frame 120 to the exterior of the inner frame 120. The liner may extend completely around the inner frame 120 for ¼, ⅓, ½, or more of the length of the inner frame 120.

[0180] Methods for placement and delivery of the prosthesis 100 can be found in U.S. Patent Application Publication No. 2018 / 005629, which is incorporated herein by reference in its entirety.

[0181] Other valve prostheses 18A-20 illustrate an alternative embodiment of a prosthesis that may be used with the disclosed delivery system 10 and methods discussed herein. FIGS. 18A-20 illustrate another alternative embodiment of a prosthesis similar to the prosthesis described with reference to the drawings of U.S. Patent Application Publication No. 2018 / 0055629, except for the description of outer frame anchoring features in FIGS. 33-35 of the aforementioned publication. U.S. Patent Application Publication No. 2018 / 0055629 is incorporated herein by reference in its entirety, including the description associated with FIGS. 33-35 and all other description related to the prosthesis, delivery system, and method. The embodiment of FIGS. 18A-20 may have similar or identical features to other prostheses discussed herein. In some embodiments, the prosthesis may be a one-frame prosthesis. In some embodiments, the prosthesis may be a two-frame prosthesis. In some embodiments for use as a replacement mitral valve, the prosthesis includes a distal or ventricular anchor similar to those described above (see, e.g., anchoring feature 1524 described below), but does not include a proximal or atrial anchor.

[0182] 18A, one embodiment of a prosthesis 1500 is shown in an expanded configuration. The prosthesis 1500 may include an inner frame 1520, an outer frame 1540, a valve body 1560, and one or more skirts, such as an outer skirt 1580 and an inner skirt 1590.

[0183] Referring first to the inner frame 1520, the inner frame 1520 may include an inner frame body 1522 and inner frame anchoring features 1524. The inner frame body 1522 may have an upper region 1522a, a middle region 1522b, and a lower region 1522c. As shown, the inner frame body 1522 may have a generally bulbous shape such that the diameters of the upper region 1522a and the lower region 1522c are less than the diameter of the middle region 1522b. The diameter of the upper region 1522a may be less than the diameter of the lower region 1522c. This may advantageously allow for a smaller valve body 1560 to be used within the inner frame 1520 and may allow the inner frame body 1522 to have a larger diameter near the junction between the inner frame body 1522 and the inner frame anchoring features 1524. This larger diameter may reduce the radial distance between the connection and the tip or end of the inner frame anchoring feature 1524. Advantageously, this may enhance the fatigue resistance of the inner frame anchoring feature 1524 by reducing the cantilever length.

[0184] While the illustrated inner frame body 1522 is bulbous, it should be understood that the diameters of the upper region 1522a, the middle region 1522b, and / or the lower region 1522c can be the same, such that the inner frame body 1522 can have a rather constant cross-sectional dimension along one or more regions. Furthermore, while the illustrated embodiment includes the lower region 1522c having a larger diameter than the upper region 1522a, it should be understood that the diameters of the upper region 1522a and the lower region 1522c can be the same, or the diameter of the upper region 1522a can be larger than the diameter of the lower region 1522c. Furthermore, while the inner frame body 1522 has been described and illustrated as being cylindrical or having a circular cross-section, it should be understood that all or a portion of the inner frame body 1522 can have a non-circular cross-section, such as, but not limited to, a D-shape, an elliptical shape, or other oval cross-sectional shape.

[0185] 18A, the outer frame 1540 may be attached to the inner frame 1520 using any suitable fasteners and / or other techniques. Although the outer frame 1540 is shown as a separate component from the inner frame 1520, it should be understood that the frames 1520, 1540 may be integrally or unitarily formed.

[0186] As shown in the illustrated embodiment, the outer frame 1540 can include an outer frame body 1542. The outer frame body 1542 can have an upper region 1542a, a middle region 1542b, and a lower region 1542c. When in an expanded configuration, such as a fully expanded configuration, the outer frame body 1542 can have an enlarged profile, with the middle region 1542b and the lower region 1542c being larger than the upper region 1542a. This enlarged profile of the outer frame body 1542 can advantageously allow the outer frame body 1542 to engage the native valve annulus, native valve leaflets, or other tissue of the body cavity while spacing the upper end away from the heart or vessel wall.

[0187] The upper region 1542a of the outer frame body 1542 may include a first section 1546a and a second section 1546b. The first section 1546a may be sized and / or shaped to generally match the size and / or shape of the inner frame 1520. For example, the first section 1546a may have a curvature that matches the curvature of the upper region 1522a of the inner frame body 1522. The second section 1546b may extend radially outward away from the inner frame 1520. As shown in the illustrated embodiment, the transition between the first section 1546a and the second section 1546b may incorporate a bend such that the second section 1546b extends radially outward at a greater angle relative to the longitudinal axis.

[0188] The middle region 1542b of the outer frame body 1542 can extend generally downward from the outwardly extending section 1546b of the upper region 1542a. As shown, the middle region 1542b can have a generally constant diameter from its upper end to its lower end such that the middle region 1542b forms a generally cylindrical shape. The lower region 1542c of the outer frame body 1542 can extend generally downward from the lower end of the middle region 1542b. As shown, the lower region 1542c of the outer frame body 1542 can have a generally constant diameter from its upper end to its lower end such that the lower region 1542c forms a generally cylindrical shape. As shown, the diameters of the middle region 1542b and the lower region 1542c are generally uniform such that the middle region 1542b and the lower region 1542c together form a generally cylindrical shape.

[0189] While the middle region 1542b and the lower region 1542c have been described as being cylindrical, it should be understood that the diameters of the upper end, the lower end, and / or the portion between the upper and lower ends can each be different. For example, the diameter of the portion between the upper and lower ends can be larger than the upper and lower ends, such that the middle region 1542b and / or the lower region 1542c form a generally bulbous shape. In some embodiments, the diameter of the lower end can be larger than the diameter of the upper end. In other embodiments, the diameter of the upper end can be larger than the diameter of the lower end. Furthermore, while the outer frame body 1542 has been described and illustrated as being cylindrical or having a circular cross-section, it should be understood that all or a portion of the outer frame body 1542 can have a non-circular cross-section, such as, but not limited to, a D-shape, an elliptical shape, or other oval cross-sectional shapes.

[0190] The outer frame 1540, such as the outer frame body 1542, can be used to mount or secure the prosthesis 1500 to a native valve, such as a native mitral valve. For example, the intermediate region 1542b of the outer frame body 1542 can be positioned to contact or engage the native annulus, tissue beyond the native annulus, the native valve leaflets, and / or other tissue at or around the implantation location during one or more phases of the cardiac cycle, such as systole and / or diastole. As another example, the outer frame body 1542 can be sized and positioned relative to the inner frame anchoring features 1524 to allow tissue of a body cavity positioned between the outer frame body 1542 and the inner frame anchoring features 1524, such as the native valve leaflets and / or the native valve annulus, to be engaged or clamped to further secure the prosthesis 1500 to the tissue.

[0191] 18A, the valve body 1560 is mounted to the inner frame 1520 within the inner frame body 1522. The valve body 1560 functions as a one-way valve to allow blood flow through the valve body 1560 in a first direction and prevent blood flow through the valve body 1560 in a second direction.

[0192] The valve body 1560 can include multiple leaflets 1562, such as, for example, three leaflets 1562, joined at commissures. The valve body 1560 can include one or more intermediate components 1564. The intermediate components 1564 can be positioned between some or all of the leaflets 1562 and the inner frame 1520 such that at least a portion of the leaflets 1562 is coupled to the frame 1520 via the intermediate components 1564. In this manner, some or all of this portion of the leaflets 1562 is not directly coupled or attached to the inner frame 1520 at the commissures and / or arcuate edges of the leaflets 1562, but is indirectly coupled or "floats" within the inner frame 1520. For example, some or all of this portion of the leaflets 1562 can be spaced radially inward from the inner surface of the inner frame 1520 near the commissures and / or arcuate edges of the leaflets 1562. The use of one or more intermediate components 1564 allows the leaflets 1562 to be attached to a non-cylindrical frame 1520 and / or a frame 1520 having a diameter larger than that of the leaflets 1562 .

[0193] 18A , the outer skirt 1580 may be attached to the inner frame 1520 and / or the outer frame 1540. As shown, the outer skirt 1580 may be positioned around and secured to a portion or all of the exterior of the outer frame 1540. The skirt 1580 may also be secured to a portion of the valve body 1560, such as, but not limited to, the intermediate component 1564. For example, the skirt 1580 may be attached to the inflow region of the intermediate component 1564. As shown, the outer skirt 1580 may follow the contours of the outer frame 1540; however, it should be understood that at least a portion of the skirt 1580 can be spaced from at least a portion of both the inner frame 1520 and the outer frame 1540.

[0194] Referring now to the inner skirt 1590 shown in FIG. 18A , the inner skirt 1590 may be attached to the valve body 1560 and the outer skirt 1580. As shown, a first end of the inner skirt 1590 may be coupled to the valve body 1560 along a portion of the valve body 1560 located near the inner frame 1520. A second end of the inner skirt 1590 may be attached to a lower region of the outer skirt 1580. In doing so, a smooth surface may be formed beneath each leaflet. This may advantageously improve hemodynamics by allowing blood to circulate more freely and reducing stagnant areas. In some embodiments, the inner skirt 1590 may advantageously reduce contact between the outer frame body 1542 and the inner frame body 1522.

[0195] Although the prosthesis 1500 has been described as including an inner frame 1520, an outer frame 1540, a valve body 1560, and skirts 1580, 1590, it should be understood that the prosthesis 1500 need not include all of the components. For example, in some embodiments, the prosthesis 1500 can include the inner frame 1520, the outer frame 1540, and the valve body 1560, while omitting the skirt 1580. Furthermore, while these components of the prosthesis 1500 have been described and illustrated as separate components, it should be understood that one or more components of the prosthesis 1500 can be integrally or unitarily formed. For example, in some embodiments, the inner frame 1520 and the outer frame 1540 can be integrally or unitarily formed as a single component.

[0196] Figure 18B shows an alternative embodiment of Figure 18A with modifications to the design of the skirts (or fabric) 1580 / 1590. As shown, the skirts 1580 / 1590 may contact both the inner frame 1520 and the outer frame 1540. These skirts 1580 / 1590 start on the inside of the outer frame 1540, transition to the exterior of the outer frame 1540, then attach to the bottom of the exterior of the inner frame 1520, and then run upward along the exterior of the inner frame 1520. By closing the skirts 1580 / 1590, this may avoid / reduce clot / thrombus formation.

[0197] 19-20, one embodiment of a prosthesis 1600 is illustrated in an expanded configuration. The prosthesis 1600 may be structurally similar to the above-described prosthesis 1500. The prosthesis 1600 may include an inner frame 1620, an outer frame 1640, a valve body 1660, and one or more skirts, such as an outer skirt 1680 and an inner skirt 1690.

[0198] Referring first to the outer frame 1640 shown in Figures 19-20, the outer frame 1640 may be attached to the inner frame 1620 using any known fasteners and / or techniques. Although the outer frame 1640 is shown as a separate component from the inner frame 1620, it should be understood that the frames 1620, 1640 may be integrally or unitarily formed.

[0199] As shown in the illustrated embodiment, the outer frame 1640 can include an outer frame body 1642. The outer frame body 1642 can have an upper region 1642a, a middle region 1642b, and a lower region 1642c. At least a portion of the upper region 1642a of the outer frame body 1642 can be sized and / or shaped to generally match the size and / or shape of the upper region 1622a of the inner frame 1620. As shown in the illustrated embodiment, the upper region 1642a of the outer frame body 1642 can include one or more struts that generally match the size and / or shape of the struts of the inner frame 1620. This can locally strengthen a portion of the prosthesis 1600 by effectively increasing the wall thickness of the combined struts.

[0200] When in an expanded configuration, such as a fully expanded configuration, the outer frame body 1642 can have a shape similar to the outer frame body 1542 described above in connection with FIG. 18A . As shown, the middle region 1642b and the lower region 1642c can have a diameter greater than the diameter of the upper region 1642a. The upper region 1642a of the outer frame body 1642 can have a diameter that decreases from its lower end to its upper end such that the upper region 1642a is tapered or curved radially inward toward the longitudinal axis of the prosthesis 1600. While the outer frame body 1642 has been described and illustrated as being cylindrical or having a circular cross-section, it should be understood that all or a portion of the outer frame body 1642 can have a non-circular cross-section, such as, but not limited to, a D-shape, an elliptical shape, or other oval cross-sectional shape.

[0201] 19, the outer frame body 1642 can include a plurality of struts, at least some of which can form cells 1646a-c. Any number of strut configurations can be used, such as the illustrated rings of undulating struts that form ovals, ellipses, rounded polygons, and teardrop shapes, but also chevrons, diamonds, curved shapes, and a variety of other shapes.

[0202] The upper row of cells 1646a may have an irregular octagonal shape, such as a "heart" shape. Advantageously, this additional space may allow the outer frame 1640 to maintain a smaller profile when crimped. The cells 1646a may be formed from a combination of struts. As shown in the illustrated embodiment, the upper portion of the cells 1646a may be formed from a set of circumferentially expandable struts 1648a having a zigzag or wavy shape that forms a repeating "V" shape. The struts 1648a may extend radially outward from an upper end to a lower end. These struts may generally match the size and / or shape of the struts of the inner frame 1620.

[0203] The middle portion of the cell 1646a may be formed from a set of struts 1648b extending downward from the bottom end of each "V" shape. These struts 1648b may extend radially outward from the upper end to the lower end. The portion of the cell 1646a extending upward from the bottom ends of the struts 1648b may be considered a substantially unshortened portion of the outer frame 1640.

[0204] The lower portion of the cell 1646a may be formed from a set of circumferentially expandable struts 1648c having a zigzag or wavy shape that forms a repeating "V" shape. As shown in the illustrated embodiment, the struts 1648c may incorporate curves such that the lower ends of the struts 1648c extend more parallel to the longitudinal axis than the upper ends of the struts 1648c. One or more of the upper ends or tips of the circumferentially expandable struts 1648c can be "free" tips that are not connected to the strut. For example, as shown in the illustrated embodiment, every other upper end or tip of the circumferentially expandable struts 1648c is a free tip. However, it should be understood that other configurations are possible. For example, every upper tip along the upper end can be connected to the strut.

[0205] The cells 1646b in the middle row and the cells 1646c in the lower row can have a different shape than the cells 1646a in the first row. The cells 1646b in the middle row and the cells 1646c in the lower row can have a diamond or approximately diamond shape. The diamond or approximately diamond shape can be formed by a combination of struts.

[0206] The upper portion of cell 1646b may be formed from a set of circumferentially expandable struts 1648c such that cell 1646b shares a strut with cell 1646a. The lower portion of cell 1646b may be formed from a set of circumferentially expandable struts 1648d. As shown in the illustrated embodiment, one or more of the circumferentially expandable struts 1648d may extend generally downward, generally parallel to the longitudinal axis of the outer frame 1640.

[0207] The upper portion of cell 1646c may be formed from a set of circumferentially expandable struts 1648d such that cell 1646c shares a strut with cell 1646b. The lower portion of cell 1646c may be formed from a set of circumferentially expandable struts 1648e. Circumferentially expandable struts 1648e may extend generally downward.

[0208] As shown in the illustrated embodiment, there may be a column of nine cells 1646a and a column of eighteen cells 1646b and 1646c. While each of the cells 1646a-1646c is shown as having the same shape as the other cells 1646a-1646c in the same column, it should be understood that the shapes of the cells 1646a-1646c within a column may be different. Furthermore, it should be understood that any number of columns of cells may be used and any number of cells may be included within a column.

[0209] As shown in the illustrated embodiment, the outer frame 1640 can include a set of eyelets 1650. The upper set of eyelets 1650 can extend from an upper region 1642a of the outer frame body 1642. As shown, the upper set of eyelets 1650 can extend from an upper portion of the cells 1646a, such as the upper tip of the cells 1646a. The upper set of eyelets 1650 can be used to attach the outer frame 1640 to the inner frame 1620. For example, in some embodiments, the inner frame 1620 can include one or more eyelets corresponding to the eyelets 1650. In such embodiments, the inner frame 1620 and the outer frame 1640 can be attached together via the eyelets 1650 and the corresponding eyelets on the inner frame 1620. For example, the inner frame 1620 and outer frame 1640 may be sewn together through the eyelets or may be attached by other means such as mechanical fasteners (eg, screws and rivets, etc.).

[0210] As shown, the set of eyelets 1650 may include two eyelets extending in series from each "V" shaped strut. This may reduce the likelihood of the outer frame 1640 twisting along the axis of the eyelets. However, it should be understood that some "V" shaped struts may not include eyelets. Furthermore, it should be understood that fewer or more eyelets may extend from a "V" shaped strut.

[0211] The outer frame 1640 may include a set of locking tabs 1652 extending from or near the upper end of the upper region 1642a. As shown, the locking tabs 1652 may extend upward from a set of eyelets 1650. The outer frame 1640 may include twelve locking tabs 1652, although it should be understood that a greater or lesser number of locking tabs may be used. The locking tabs 1652 may include longitudinally extending struts 1652a. At the upper ends of the struts 1652a, the locking tabs 1652 may include enlarged heads 1652b. As shown, the enlarged heads 1652b may have semicircular or semi-elliptical portions that form a "mushroom" shape with the struts 1652a. The locking tabs 1652 may include an eyelet 1652c that may be positioned through the enlarged heads 1652b. It should be understood that the locking tab 1652 may have eyelets in other locations or may have more than one eyelet.

[0212] Advantageously, the locking tabs 1652 can be used with multiple types of delivery systems. For example, the shape of the struts 1652a and enlarged heads 1652b can be used to secure the outer frame 1640 to a "slot"-based delivery system, such as the inner retention member 40 described above. The eyelets 1652c and / or eyelets 1650 can be used to secure the outer frame 1640 to a "tether"-based delivery system, such as those that use sutures, wires, or fingers to control the delivery of the outer frame 1640 and prosthesis 1600. This can advantageously facilitate in-situ recapture and repositioning of the outer frame 1640 and prosthesis 1600.

[0213] The outer frame 1640, such as the outer frame body 1642, can be used to mount or secure the prosthesis 1600 to a native valve, such as a native mitral valve. For example, the intermediate region 1642b of the outer frame body 1642 and / or the outer anchoring features 1644 can be positioned to contact or engage the native annulus, tissue beyond the native annulus, the native valve leaflets, and / or other tissue at or around the implantation location during one or more phases of the cardiac cycle, such as systole and / or diastole. As another example, the outer frame body 1642 can be sized and positioned relative to the inner frame anchoring features 1624 to allow tissue of a body cavity positioned between the outer frame body 1642 and the inner frame anchoring features 1624, such as the native valve leaflets and / or the native valve annulus, to be engaged or clamped to further secure the prosthesis 1600 to the tissue. As shown, the inner frame anchoring feature 1624 includes nine anchors, although it should be understood that fewer or more anchors may be used. In some embodiments, the number of individual anchors may be selected as a multiple of the number of commissures in the valve body 1660. For example, the valve body 1660 may have three commissures, and the inner frame anchoring feature 1624 may have three individual anchors (1:1 ratio), six individual anchors (2:1 ratio), nine individual anchors (3:1 ratio), twelve individual anchors (4:1 ratio), fifteen individual anchors (5:1 ratio), or any other multiple of three. In some embodiments, the number of individual anchors does not correspond to the number of commissures in the valve body 1660.

[0214] 19-20, the valve body 1660 is mounted to the inner frame 1620 within the inner frame body 1622. The valve body 1660 functions as a one-way valve to allow blood flow through the valve body 1660 in a first direction and prevent blood flow through the valve body 1660 in a second direction.

[0215] The valve body 1660 may include multiple leaflets 1662, such as, for example, three leaflets 1662, joined at commissures. The valve body 1660 may include one or more intermediate components 1664. The intermediate components 1664 may be positioned between some or all of the leaflets 1662 and the inner frame 1620 such that at least a portion of the leaflets 1662 is coupled to the frame 1620 via the intermediate components 1664. In this manner, some or all of this portion of the leaflets 1662 is not directly coupled or attached to the inner frame 1620 at the commissures and / or arcuate edges of the leaflets 1662, but is indirectly coupled or "floating" within the inner frame 1620.

[0216] Referring now to the outer skirt 1680 shown in FIG. 19 , the outer skirt 1680 may be attached to the inner frame 1620 and / or the outer frame 1640. As shown, the outer skirt 1680 may be positioned around and secured to a portion or all of the exterior of the outer frame 1640. The inner skirt 1690 may be attached to the valve body 1660 and the outer skirt 1680. As shown in FIG. 40 , a first end of the inner skirt 1690 may be coupled to the valve body 1660 along a portion of the valve body 1660 located near the inner frame 1620. A second end of the inner skirt 1690 may be attached to the lower region of the outer skirt 1680. In doing so, a smooth surface may be formed along the underside of each leaflet. This may advantageously improve hemodynamics by allowing for freer circulation of blood and reducing stagnant areas.

[0217] While the prosthesis 1600 has been described as including an inner frame 1620, an outer frame 1640, a valve body 1660, and skirts 1680, 1690, it should be understood that the prosthesis 1600 need not include all of the components. For example, in some embodiments, the prosthesis 1600 can include the inner frame 1620, the outer frame 1640, and the valve body 1660, while omitting the skirt 1680. Furthermore, while these components of the prosthesis 1600 have been described and illustrated as separate components, it should be understood that one or more components of the prosthesis 1600 can be integrally or unitarily formed. For example, in some embodiments, the inner frame 1620 and the outer frame 1640 can be integrally or unitarily formed as a single component.

[0218] 21 shows one embodiment of a frame for a prosthesis 1600 that can have two different sizes. These prostheses 1600 can be scaled only in size; there is no substantial / functional difference between the two. Also, the prosthesis 100 can be made in a variety of sizes.

[0219] FIG. 22 shows the inner frame 1620 of the prosthesis 1600, and FIG. 23 shows the outer frame 1640 of the prosthesis 1600.

[0220] While FIG. 24 shows the distal end of the inner frame anchoring feature 1624 of the prosthesis 1600, the same structure can be used for any of the prostheses 100 disclosed herein. As shown, the distal tip 1625 of the inner frame anchoring feature 1624 can include two struts 1627 terminating in generally L-shaped anchors 1629 that face in opposite circumferential directions. As shown, the L-shaped anchors 1629 are not circumferentially aligned such that each L-shaped anchor 1629 has a free end. For example, the first strut 1627 can be bent radially inward relative to the second strut 1627. The L-shaped anchors 1629 can be spaced 1, 2, 3, 4, 5, or 6 mm apart from one another. In some embodiments, a greater number of struts 1627 and a greater number of anchors 1629 can be used. The L-shaped anchor 1629 provides a larger attachment area for any cushion / suture, thereby preventing the cushion from sliding or moving.

[0221] Anchor Separator 25A-27B show embodiments of anchor separators that may be used with any of the prosthesis embodiments described above.

[0222] In some loading procedures, the inner frame anchoring features disclosed herein, when loaded, may not be loaded uniformly, but instead may be loaded in a cross or spiral pattern. This uneven loading can be detrimental because it can cause uneven deformation strains on the inner frame anchoring features, which can make the prosthesis more vulnerable to fracture or cracking. Also, uneven loading can increase the loading and / or deployment forces of the valve, which can cause additional loads on the frame, soft tissue, or fiber / suture components.

[0223] 25A-25B illustrate one embodiment of an anchor separator 2500. As shown, the anchor separator 2500 can be a body 2502 having a lumen 2504 extending generally along a longitudinal centerline of the body 2502. The anchor separator 2500 can also include a plurality of longitudinally extending grooves 2506 formed by a plurality of extensions 2508 on an outer radial surface of the body 2502. The body 2502 can be generally tubular, with the extensions 2508 extending radially away from the tubular body 2502.

[0224] As shown, the extensions 2508 can be generally triangular in shape with the base of the triangle located at the radially outermost position, although this particular shape is not limiting. Adjacent extensions 2508 form generally triangular grooves 2506 or slots therebetween along the longitudinal length of the body 2502 that are configured to receive the inner frame anchoring features 1624. In some embodiments, the extensions / grooves 2508 / 2506 can extend along the entire longitudinal length of the body 2502. In some embodiments, the extensions / grooves 2508 / 2506 can extend 95%, 90%, 85%, 80%, or 75% of the longitudinal length of the body 2502. In some embodiments, the extensions / grooves 2508 / 2506 can extend over more than 95%, 90%, 85%, 80%, or 75% of the longitudinal length of the body 2502. In some embodiments, the extensions / grooves 2508 / 2506 can extend over less than 95%, 90%, 85%, 80%, or 75% of the longitudinal length of the body 2502.

[0225] In some embodiments, the body 2502 can have 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 grooves 2506. In some embodiments, the body 2502 can have more than 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 grooves 2506. In some embodiments, the body 2502 can have fewer grooves 2506 than the number of inner frame anchoring features 1624 in the prosthesis. In some embodiments, the body 2502 can have fewer grooves 2506 than the number of inner frame anchoring features 1624 in the replacement valve. In some embodiments, the body 2502 can have more grooves 2506 than the replacement valve has inner frame anchoring features 1624 .

[0226] 25A-25B, the body 2502 can taper radially inward (e.g., generally along the longitudinal axis) toward the proximal and distal ends of the body 2502. Additionally, as shown, the extensions 2508 can extend radially inward at the proximal and distal ends as well. This can mitigate or prevent the separator 2500 from catching on the deployed prosthesis when the deployment system is retracted through the prosthesis.

[0227] Thus, the inner frame anchoring features can be releasably loaded into the grooves 2506 to prevent their twisting, rotation, movement, or out-of-plane displacement. The inner frame anchoring features can be retained in the grooves 2506 by a radially outer sheath, and when the sheath is removed, the inner frame anchoring features 1624 can be released from the grooves 2506. In FIG. 26, an example prosthesis is shown with anchoring features 1624 (but 124 could be used as well) inserted into the separator 2500. The inner frame anchoring features can be uniformly loaded along the periphery of the separator 2500. FIGS. 27A-27B show a separator 2500 for use with a delivery system, such as the delivery system 10 disclosed below.

[0228] In some embodiments, separator 2500 is capable of sliding along a shaft, such as the nosecone shaft of the delivery systems described in U.S. Patent Application Publication Nos. 2017 / 0056169, 2016 / 0317301, 2017 / 0056171, and 2019 / 0008640. These publications are incorporated herein by reference in their entireties. In some embodiments, separator 2500 may be fixed relative to the shaft. In some embodiments, separator 2500 may have axial / longitudinal degrees of freedom along the shaft. In some embodiments, separator 2500 may have rotational degrees of freedom along the shaft. Preferably, separator 2500 is fixed axially but may rotate freely. This allows the separator 2500 to adjust as the prosthesis is pulled into the delivery system catheter, thereby circumferentially aligning all of the inner frame anchoring features. In some embodiments, the separator 2500 may not be attached to the delivery system.

[0229] Delivery system suture attachment 28A-28B show a prosthesis 100 comprising any of those discussed above having a suture 2802 configured to attach to a delivery system such as those discussed below. For example, fingers, knobs, or a shaft in the delivery system may releasably hold the suture 2802. In some embodiments, the delivery system may include an additional suture for coupling to the suture 2802, such as that shown in FIG. 28B. This additional suture 2804 may be wrapped and / or twisted around the suture 2802 to couple the prosthesis 100 to the delivery system.

[0230] The sutures 2802 may be permanently attached to the prosthesis 100 or may be removed upon delivery. In some embodiments, the sutures 2802 may be biodegradable.

[0231] As shown, the sutures 2802 may extend generally along the outer edge of the atrial end of the prosthesis 100. In some embodiments, the sutures 2802 may extend completely or partially along this outer edge. The sutures 2802 may be attached to the prosthesis 100 in a number of ways. In some embodiments, the sutures 2802 may pass through eyelets 120 in the outer frame. The sutures 2802 may pass through all or some of these eyelets 120. In some embodiments, the sutures 2802 may be wrapped or otherwise attached to tabs 104 on the inner frame. In some embodiments, the sutures 2802 may be attached to both the outer and inner frames. In some embodiments, the sutures 2802 may be compressed between these two frames. In some embodiments, the sutures 2802 may be attached to the prosthesis 100 chemically, mechanically, or the like.

[0232] Delivery System FIG. 35 illustrates one embodiment of a delivery device, delivery system, or delivery assembly 10, such as that described in U.S. Patent Application Publication No. 2019 / 0008640, which is incorporated herein by reference in its entirety. The delivery system 10 can be used to deploy a prosthesis, such as a replacement heart valve, within the body. In some embodiments, the delivery system 10 can utilize a dual-plane deflection approach to properly deliver the prosthesis. The replacement heart valve can be delivered to the patient's mitral annulus or other heart valve location in a variety of ways, such as by open-heart surgery, minimally invasive surgery, and percutaneous or transcatheter delivery via the patient's vasculature. An example of a transfemoral approach can be found in U.S. Patent Application Publication No. 2015 / 0238315, filed February 20, 2015, which is incorporated herein by reference in its entirety. Although delivery system 10 is described in the context of a percutaneous delivery approach and more specifically a transfemoral delivery approach, it should be understood that the features of delivery system 10 may be applied to other delivery systems, including delivery systems for transapical delivery approaches.

[0233] Delivery system 10 can be used to deploy a prosthesis, such as a replacement heart valve as described elsewhere herein, within the body. Delivery system 10 can receive and / or cover portions of a prosthesis, such as a first end (e.g., an atrial end) and a second end (e.g., a ventricular end) of prosthesis 100. For example, delivery system 10 can be used to deliver an expandable implant or prosthesis 100, which includes a first end and a second end, the second end being configured to be deployed or expanded before the first end. A discussion of the attachment of prosthesis 100 to delivery system 10 can be found in U.S. Patent Application Publication No. 2015 / 0328000 A1, which is incorporated herein by reference in its entirety. Further details and embodiments of the replacement heart valve or prosthesis, and methods of implantation thereof, are described in U.S. Patent Application Publication Nos. 2015 / 0328000 and 2016 / 0317301, the entireties of which are incorporated by reference herein and made a part of this specification.

[0234] Delivery system 10 can be relatively flexible. In some embodiments, delivery system 10 is particularly suited for delivering a replacement heart valve via a transseptal approach to the mitral valve location (e.g., between the right and left atria via a transseptal puncture).

[0235] As shown in FIG. 35 , the delivery system 10 may include a shaft assembly 12 having a proximal end 11 and a distal end 13. A handle 14 is coupled to the proximal end of the assembly 12. The shaft assembly 12 may be used to hold the prosthesis for advancement through a vessel to a treatment location. The delivery system 10 may further include a relatively rigid, live-on (or one-piece) sheath 51 surrounding the shaft assembly 12, which may prevent undesired movement of the shaft assembly 12. The rib-on sheath 51 may be attached to the proximal end of the shaft assembly 12 proximal to the handle 14, for example, at the shaft hub. The shaft assembly 12 may include an implant retention region at its distal end that may be used for this purpose. In some embodiments, the shaft assembly 12 may hold the expandable prosthesis in a compressed state at the implantation region for advancement of the prosthesis 100 within the body. The shaft assembly 12 may then be used to enable controlled expansion of the prosthesis 100 at the treatment location. In some embodiments, the shaft assembly 12 may be used to allow for continuous, controlled expansion of the prosthesis 100. In some embodiments, the prosthesis 100 may be rotatable at the implant holding area.

[0236] As discussed in U.S. Patent Application Publication No. 2019 / 0008640, the distal end of delivery system 10 may include one or more subassemblies, such as an outer sheath assembly, a midshaft assembly, a rail assembly, an inner shaft assembly, and a nosecone assembly. In some embodiments, delivery system 10 may not have all of the assemblies disclosed herein. For example, in some embodiments, the entire midshaft assembly may not be incorporated into delivery system 10.

[0237] In particular, embodiments of the disclosed delivery system 10 may enable proper placement of an implant within a patient's body by using a steerable rail in a rail assembly to steer the distal end of the delivery system 10. The steerable rail can be, for example, a rail shaft extending through the delivery system 10 from the handle 14 to approximately the distal end. In some embodiments, the steerable rail has a distal end that terminates proximal to the implant holding area. A user can bend the rail in a particular direction by manipulating the bend in the distal end of the rail. In preferred embodiments, the rail has two or more bends along its length, thereby achieving multi-directional bending. As the rail is bent, it compresses other assemblies, further bending them, so that other assemblies of the delivery system 10 can be configured to be steered with the rail as a cooperative, single unit, thereby achieving full steerability of the distal end of the delivery system.

[0238] Once the rails are maneuvered to a specific location within the patient's body, the prosthesis 100 can be advanced along or relative to the rails via movement of other sheaths / shafts relative to the rails and released into the body. For example, the rails can be bent to a desired location within the body, such as orienting the prosthesis 100 toward the native mitral valve. Other assemblies (e.g., the outer sheath assembly, midshaft assembly, inner assembly, and nosecone assembly) can passively follow the bending of the rails. Furthermore, other assemblies (e.g., the outer sheath assembly, midshaft assembly, inner assembly, and nosecone assembly) can be advanced together relative to the rails (e.g., relatively together, sequentially with an actuator, simultaneously, nearly simultaneously, in unison, in a near-unison manner, etc.) while maintaining the prosthesis 100 in a compressed position (e.g., within an implant holding region) without releasing or expanding the prosthesis 100. Other assemblies (e.g., the outer sheath assembly, midshaft assembly, inner assembly, and nosecone assembly) can be advanced together distally or proximally relative to the rails. In some embodiments, only the outer sheath assembly, midshaft assembly, and inner assembly are advanced together on the rails. Thus, the nosecone assembly may remain in the same position. These assemblies may be translated individually, sequentially, or simultaneously relative to the inner assembly to release the implant 100 from the implant holding area.

[0239] In some embodiments, the outer sheath assembly, the midshaft assembly, the inner shaft assembly, and the nosecone assembly translate together (e.g., relatively together, sequentially with an actuator, simultaneously, nearly simultaneously, in unison, in a near-union manner, etc.) This distal translation can occur while the implant 100 maintains a compressed configuration within the implant holding region.

[0240] Starting with the outermost assembly, the delivery system 10 may include an outer sheath assembly that forms a radially outer covering or sheath to surround an implant-retaining area and prevent radial expansion of the implant. Specifically, the outer sheath assembly may prevent radial expansion of the distal end of the implant. Proceeding radially inward, a midshaft assembly is comprised of a midshaft hypotube, the distal end of which may be attached to an outer retention member or ring to radially retain a portion of the prosthesis in a compact configuration, such as the proximal end of the prosthesis 100. The midshaft assembly may be disposed within the lumen of the outer sheath assembly. Proceeding further inward, a rail assembly may be configured for maneuverability, as described above and further below. The rail assembly may be disposed within the lumen of the midshaft assembly. Further inward, the inner shaft assembly comprises an inner shaft, the distal end of which may be attached to an inner retention member or ring (such as a PEEK ring) for axially retaining the prosthesis, e.g., the proximal end of the prosthesis. The inner shaft assembly may be disposed within the lumen of the rail assembly. Further, the radially innermost assembly is a nosecone assembly, which includes a nosecone shaft connected at its distal end to the nosecone. The nosecone may have a tapered tip. The nosecone assembly is preferably disposed within the lumen of the inner shaft assembly. The nosecone assembly may include a lumen for passing a guidewire.

[0241] The shaft assembly 12, and more specifically the nosecone assembly, inner assembly, rail assembly, midshaft assembly, and outer shaft assembly, may be collectively configured to deliver the prosthesis 100 positioned within the implant-retaining region to a treatment location. One or more of these subassemblies may then be moved to release the prosthesis 100 at the treatment location. For example, one or more of the subassemblies may be movable relative to one or more of the other subassemblies. The handle 14 may include various control mechanisms that may be used to control the movement of the various subassemblies, as described in more detail below. In this manner, the prosthesis 100 may be controllably loaded into the delivery system 10 and then later deployed within the body. Additionally, the handle 14 may provide steering relative to the rail assembly, thereby enabling bending / flexing / steering of the distal end of the delivery system 10.

[0242] The inner retention member, outer retention ring, and outer sheath assembly may cooperate to hold the prosthesis 100 in a compact configuration. The inner retention member may engage struts (e.g., 132a / 132b) at the proximal end of the prosthesis 100 in FIG. 2 . For example, slots located between radially extending teeth of the inner retention member may receive and engage struts that may terminate in mushroom-shaped tabs on the proximal end of the prosthesis 100. The midshaft assembly may be positioned over the inner retention member such that a first end of the prosthesis 100 is captured between the inner retention member and the outer retention ring, securely mounting the prosthesis 100 to the delivery system 10 between the midshaft assembly and the inner retention member. The outer sheath assembly may be positioned over the second end of the prosthesis 100.

[0243] The outer retention member may be attached to the distal end of the midshaft hypotube, which in turn may be attached at its proximal end to the proximal tube, which in turn may be attached at its proximal end to the handle 14. The outer retention member may provide additional stability to the prosthesis 100 when in a compressed position. The outer retention member may be positioned over the inner retention member such that the proximal end of the prosthesis 100 is captured between the outer and inner retention members, securely mounting the prosthesis 100 to the delivery system 10. The outer retention member may encircle a portion of the prosthesis 100, specifically the first end, thus preventing expansion of the prosthesis 100. Additionally, the midshaft assembly may be translated proximally relative to the inner assembly into the outer sheath assembly, thus exposing the first end of the prosthesis 100 retained within the outer retention member. In this manner, the outer retention member may be used to secure the prosthesis 100 to the delivery system 10 or to aid in the release of the prosthesis 100 from the delivery system 10. The outer retention member may have a cylindrical or elongated tubular shape and may be referred to as an outer retention ring, although this particular shape is not limiting.

[0244] The midshaft hypotube itself may be made from, for example, high-density polyethylene (HDPE) and other suitable materials as described herein. The midshaft hypotube can be formed from a longitudinally pre-compressed HDPE tube, which offers certain advantages. For example, the pre-compressed HDPE tube may apply a distal force to the outer retention member, thus preventing accidental, inadvertent, and / or premature release of the prosthesis 100. Specifically, the distal force exerted by the midshaft hypotube holds the distal end of the outer retention member distal to the inner retention member, thus preventing the outer retention member from moving proximally of the inner retention member before the user desires to release the prosthesis 100. This can be maintained even when the delivery system 10 is bent / deflected at an acute angle. Further disclosure of the outer retention member and midshaft hypotube can be found in U.S. Patent Application Publication No. 2016 / 0317301, which is incorporated herein by reference in its entirety.

[0245] In the compressed position, the inner frame anchoring features 124 may be positioned in a delivery configuration with the inner frame anchoring features 124 facing generally distally. The inner frame anchoring features 124 may be held in this delivery configuration by the outer sheath assembly. Thus, when the outer sheath is pulled proximally, the inner frame anchoring features 124 may reposition (e.g., bend approximately 180 degrees) to the deployed configuration (e.g., facing generally proximally). In other embodiments, the inner frame anchoring features 124 may be held facing generally proximally in the delivery configuration and compress the body of the prosthesis frame.

[0246] The delivery system 10 may be provided to the user with the prosthesis 100 pre-installed. In other embodiments, the prosthesis 100 may be loaded into the delivery system immediately prior to use by a doctor, nurse, or the like.

[0247] Valve Delivery Positioning Methods of using the delivery system 10 in connection with a replacement mitral valve will now be described. Specifically, the delivery system 10 may be used in methods for percutaneously delivering a replacement mitral valve to treat patients suffering from moderate to severe mitral regurgitation. The following methods are merely examples of how the delivery system may be used. It should be understood that the delivery systems described herein may also be used as part of other methods.

[0248] As shown in FIG. 32 , in one embodiment, the delivery system 10 may be placed into the ipsilateral femoral vein 1074 and advanced toward the right atrium 1076. A transseptal puncture using known techniques may then be performed to gain access to the left atrium 1078. The delivery system 10 may then be advanced into the left atrium 1078 and then into the left ventricle 1080. FIG. 32 shows the delivery system 10 extending from the ipsilateral femoral vein 1074 to the left atrium 1078. In embodiments of the present disclosure, a guidewire is not required to position the delivery system 10 in the appropriate location, although in other embodiments, one or more guidewires may be used.

[0249] It would therefore be advantageous for a user to be able to navigate the delivery system 10 through complex regions of the heart to position the replacement mitral valve in alignment with the native mitral valve. This task can be performed with or without the use of a guidewire with the systems disclosed above. The distal end of the delivery system can be advanced into the left atrium 1078. The user can then manipulate the rail assembly to target the distal end of the delivery system 10 to the appropriate region. The user can then continue passing the bent delivery system 10 through a transseptal puncture into the left atrium 1078. The user can then further manipulate the delivery system 10 to impart an even greater bend in the rail assembly. Additionally, the user can rotate the entire delivery system 10 to further manipulate and control the position of the delivery system 10. In the fully bent configuration, the user can position the replacement mitral valve in the appropriate position. Advantageously, this may enable delivery of a replacement valve to an in situ implantation site, such as a native mitral valve, via a variety of approaches, such as a transseptal approach.

[0250] The rail assembly may be particularly advantageous for entry into the native mitral valve. As discussed above, the rail assembly may form two bends, both of which may be positioned within the left atrium 1078. The bends in the rail assembly may position the prosthesis (such as any of the designs disclosed above) so that it is coaxial with the native mitral valve. Once the prosthesis is coaxial, the outer sheath assembly, midshaft assembly, inner assembly, and nosecone assembly may be advanced together distally relative to the rail assembly (e.g., using the depth knob on the handle). These assemblies are advanced linearly away from the rail assembly, thus advancing them coaxially with the native mitral valve until the prosthesis is released while maintained in a compressed configuration, as discussed below.

[0251] Reference is now made to FIG. 33 , which shows a schematic diagram of a portion of one embodiment of a replacement heart valve 100 positioned within a native mitral valve of a heart 83. Further details regarding the manner in which a prosthesis may be positioned within a native mitral valve are described in U.S. Patent Application Publication No. 2015 / 0328000 A1, the entirety of which is incorporated herein by reference, including, but not limited to, FIGS. 13A-15 and paragraphs

[0036] -

[0045] . A portion of a native mitral valve is shown schematically, representing a typical anatomical structure with the left atrium positioned above the annulus 1106 and the left ventricle positioned below the annulus 1106. The left atrium and left ventricle communicate with each other via the mitral valve annulus 1106. Also shown in FIG. 33 are the native mitral valve leaflets 1108, with chordae tendineae 1110 connecting their downstream ends to the papillary muscles of the left ventricle 1080. The portion of the prosthesis 100 disposed upstream of the annulus 1106 (towards the left atrium) can be referred to as being supranulnarly positioned. The portion located approximately within the annulus 1106 is referred to as being intraannularly positioned. The portion downstream of the annulus 1106 is referred to as being subannularly positioned (towards the left ventricle).

[0252] 33, a replacement heart valve (e.g., prosthesis 100) may be positioned so that the mitral valve annulus 1106 is disposed above the inner frame anchoring features 124. In some circumstances, the prosthesis 100 may be positioned so that the ends or tips of the inner frame anchoring features 124 contact the annulus 1106, as shown in FIG. 33, for example. In some circumstances, the prosthesis 100 may be positioned so that the ends or tips of the inner frame anchoring features 124 do not contact the annulus 1106. In some circumstances, the prosthesis 100 may be positioned so that the inner frame anchoring features 124 do not extend around the valve leaflets 1108.

[0253] As shown in FIG. 33 , the replacement heart valve 70 can be positioned so that the ends or tips of the inner frame anchoring features 124 lie on the ventricular side of the mitral valve annulus 1106. The inner frame anchoring features 124 can be positioned so that the ends or tips of the inner frame anchoring features 124 lie on the ventricular side of the native valve leaflets beyond where the chordae tendineae 1110 connect to the free ends of the native leaflets. The inner frame anchoring features 124 can extend between at least some of the chordae tendineae 1110 and, in some situations, such as those shown in FIG. 33 , can contact or engage the ventricular side of the annulus 1106. It is also contemplated that, in some situations, the inner frame anchoring features 124 may not contact the annulus 1106, but the inner frame anchoring features 124 can still contact the native valve leaflets 1108. In some circumstances, the inner frame anchoring features 124 may contact tissue of the left ventricle 1080 beyond the annulus 1106 and / or the ventricular aspects of the leaflets.

[0254] During delivery, the inner frame anchoring features 124 (together with the frame) can be moved toward the ventricular side of the annulus 1106, such as by translating other assemblies proximally relative to the rail assembly, with the inner frame anchoring features 124 extending between at least some of the chordae 1110 to apply tension to the chordae 1110. The degree of tension applied to the chordae 1110 can vary. For example, if the leaflets 1108 are shorter or similar in size than the inner frame anchoring features 124, there may be little or no tension in the chordae 1110. If the leaflets 1108 are longer than the inner frame anchoring features 124 and therefore assume a compact shape and are pulled proximally, there may be a greater degree of tension in the chordae 1110. If the leaflets 1108 are even longer relative to the inner frame anchoring features 124, there may be an even greater degree of tension in the chordae tendineae 1110. The leaflets 1108 can be long enough so that the inner frame anchoring features 124 do not contact the annulus 1106.

[0255] As discussed above, the prosthesis 100 may not include outer frame anchoring features. However, some embodiments, such as that shown in FIG. 12 , may include outer frame anchoring features 144. If present, the outer frame anchoring features 144 may be positioned such that the ends or tips of the outer frame anchoring features 144 are adjacent to tissue on the atrial side of the annulus 1106 and / or beyond the annulus 1106 in the left atrium. In some circumstances, some or all of the outer frame anchoring features 144 may only occasionally contact or engage tissue on the atrial side of the annulus 1106 and / or beyond the annulus 1106 in the left atrium 1078. For example, the outer frame anchoring features 144 may be spaced apart from tissue on the atrial side of the annulus 1106 and / or beyond the annulus 1106 in the left atrium. The outer frame anchoring features 144 may provide axial stability to the prosthesis 100. It is also contemplated that some or all of the outer frame anchoring features 144 may contact the atrial aspect of the annulus 1106 and / or tissue in the left atrium beyond the annulus 1106. FIG. 34 illustrates the prosthesis 100 implanted in a heart 83. While the illustrated replacement heart valve includes both proximal and distal anchors, it will be understood that proximal and distal anchors are not required in all instances. For example, a replacement heart valve having only a distal anchor may be able to securely maintain the replacement heart valve within the annulus. This is because the greatest force on the replacement heart valve is directed toward the left atrium during systole. Therefore, the distal anchor is most important for anchoring the replacement heart valve within the annulus and preventing migration.

[0256] From the foregoing, it will be appreciated that the present invention discloses products and approaches relating to implantable prostheses. While several components, techniques, and aspects have been described with particular specificity, it will be apparent that numerous changes can be made in the specific designs, structures, and methods described hereinabove without departing from the spirit and scope of the present disclosure.

[0257] Some features described within this disclosure in the context of separate implementations can also be implemented in combination with a single implementation. Conversely, various features described in the context of a single implementation can also be implemented in multiple implementations separately or in any specific subcombination. Furthermore, while features may be described above as functioning in several combinations, one or more features in a claimed combination can be deleted from the combination in some instances, and the combination may be claimed as any subcombination or variation thereof.

[0258] Furthermore, while these methods may be shown in the figures and described herein in a particular order, such methods need not be performed in the particular order or sequential order shown, and not all of these methods need be performed to achieve desirable results. Other methods not shown or described may be incorporated into these example methods and processes. For example, one or more additional methods could be performed before, after, simultaneously with, or between any of the described methods. Furthermore, these methods may be rearranged or reordered in other implementations. Also, the separation of various system components in the above-described embodiments should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products. Furthermore, other implementations are within the scope of this disclosure.

[0259] Conditional phrases such as "can" or "may" are generally intended to convey that a particular embodiment includes or does not include particular features, elements, and / or steps, unless specifically stated otherwise or understood otherwise within the context in which they are used. Thus, such conditional phrases are generally not intended to imply that features, elements, and / or steps are in any way required for one or more embodiments.

[0260] Unless specifically stated otherwise, connective language such as "at least one of X, Y, and Z" is understood in the context in which it is generally used to convey that, in other words, an item, term, etc., can be either X, Y, or Z. Thus, such connective language is not generally intended to suggest that a particular embodiment requires the presence of at least one X, at least one Y, and at least one Z.

[0261] As used herein, expressions of degree, such as "about," "approximately," "substantially," and the like, refer to a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms "about," "approximately," "substantially," and "substantially" can refer to an amount that is within 10% or less, 5% or less, 1% or less, 0.1% or less, and 0.01% or less of the stated amount. When a stated amount is 0 (e.g., absent), the ranges listed above are specific ranges, not within a certain percentage of the numerical value. For example, it is possible for the amount to be within 10% or less, 5% or less, 1% or less, 0.1% or less, and 0.01% or less of the stated amount.

[0262] Several implementations have been described in connection with the accompanying drawings. While these drawings are drawn to scale, such scale should not be considered limiting, as dimensions and proportions other than those illustrated are contemplated and fall within the inventive scope of the present disclosure. Distances, angles, and the like are merely illustrative and do not necessarily maintain precise relativity to the actual dimensions and layout of the illustrated devices. Components may be added, removed, and / or rearranged. Furthermore, any particular feature, aspect, method, property, attribute, quality, attribute, or element disclosed herein in connection with various embodiments may be utilized in any other embodiment shown herein. Furthermore, it will be understood that any method described herein may be implemented using any device suitable for performing the recited steps.

[0263] While several embodiments and variations thereof have been described in detail, other modifications and methods of using them will become apparent to those skilled in the art. It is therefore to be understood that various applications, modifications, materials, and substitutions may be made without departing from the inherent and inventive disclosure herein or the scope of the claims. [Explanation of symbols]

[0264] 10 Delivery systems, delivery devices, and delivery assemblies 11 Proximal end 12 Shaft Assembly 13 distal end 14 Handle 16 Prosthesis 40 Inner holding member 50 Secondary inner frame 51 Rib on Sheath 70 Replacement Heart Valves 83 Heart 100 Multi-portion prostheses, prostheses, implants, replacement heart valves 102 Longitudinal axis 104 Tab, locking tab 106 Eye hole 118 tabs 120 inner frame 121 First Ingredient 122 Inner frame body 123 Second Ingredient 124 Inner Frame Anchoring Feature 124a End, tip 126 Upper area 128 Intermediate area 130 Lower area 132a longitudinally extending strut 132b Enlarged Head 134a Upper row cells 134b Lower row of cells 136a Circumferentially expandable strut, circumferentially extending strut 136b Circumferentially expandable strut, circumferentially extending strut 138 Cover, cushion, longitudinally extending strut 140 outer frame 142 Outer frame body 143 Eye hole 144 outer frame anchoring feature 144a End 145 tabs 146 Upper area 146a substantially longitudinally extending section 146b Outward extending section 148 Intermediate area 150 Lower area 151 Notch 152 Bend 154 cells 156 Strut 156a Circumferentially expandable strut 156b Strut 156a' strut 156b' strut 160 Valve body 180 Outer Skirt 182 Ventricular part 192 Added stiffness improving materials 220 inner frame, hourglass-shaped inner frame 220' inner frame, hourglass-shaped inner frame 226 Upper area 226' upper area 228 Intermediate area 228' intermediate area 230 Lower area 230' lower area 231 Valve Leaflet 232 Locking Tab 262 Valve Leaflet 502 Secondary Inner Frame, Hourglass Shaped Secondary Inner Frame 642 Outer frame body 1074 Ipsilateral femoral vein 1076 Right atrium 1078 Left atrium 1080 left ventricle 1106 Mitral annulus 1108 Mitral valve leaflet, natural mitral valve leaflet, valve leaflet, natural valve leaflet 1110 Chordae tendineae 1420 Inner Frame 1500 Prosthesis 1504 lumens 1520 Inner frame, non-cylindrical frame 1522 Inner frame body 1522a Upper area 1522b Intermediate area 1522c Lower area 1524 Inner Frame Anchoring Feature 1540 outer frame 1542 Outer frame body 1542a Upper area 1542b Intermediate area 1542c Lower area 1546a First Section 1546b Second section, outward extension section 1560 Valve body 1562 Valve Leaflet 1564 Intermediate Components 1580 Outer skirt, cloth 1590 Inner skirt 1600 Prosthesis 1620 Inner Frame 1622 Inner frame body 1622a upper region 1624 Inner Frame Anchoring Feature 1625 Distal tip 1627 First Strut 1627 Second Strut 1629 Approximately L-shaped anchor 1640 outer frame 1642 Outer frame body 1642a upper region 1642b Intermediate area 1642c lower area 1644 Outer Anchoring Feature 1646a Cell 1646b cell 1646c Cell 1648a Circumferentially expandable strut 1648b Strut 1648c Circumferentially Expandable Strut 1648d Circumferentially Expandable Strut 1648e Circumferentially Expandable Strut 1650 eye hole 1652 Locking Tab 1652a Longitudinally extending strut 1652b Enlarged Head 1652c eye hole 1660 Valve body 1662 Valve Leaflet 1664 Intermediate Components 1680 Outer Skirt 1690 Inner skirt 2500 Anchor Separator 2502 Body, tubular body 2504 lumens 2506 Longitudinal groove 2508 Extension 2802 Sutures 2804 Sutures

Claims

[Claim 1] 10. A heart valve prosthesis as herein described and illustrated.

Images