Multi-part replacement heart valve prosthesis

Abstract

The present application relates to a multi-part replacement heart valve prosthesis. The replacement mitral valve prosthesis includes a support structure and a valve body having three flexible leaflets. The support structure preferably includes an inner valve frame and an outer sealing frame. The valve frame supports the flexible leaflets. The sealing frame is adapted to conform to the shape of a native mitral annulus. The sealing frame can be coupled to an inlet end of the valve frame, an outlet end of the valve frame, or both. A plurality of anchors are coupled to the outlet end of the valve frame. The anchors extend radially outward to be disposed behind native leaflets. The prosthesis preferably includes a skirt disposed along an exterior of the outer sealing frame. The prosthesis is collapsible for delivery into the heart by a delivery catheter. The prosthesis is configured to self-expand for deployment in the heart upon release from the delivery catheter.

Description

[0001] This application is a divisional application. The original application was filed on August 25, 2017, with application number 201780062590.2 and invention title "Multipart Replacement Heart Valve Prosthesis". Technical Field

[0002] Some of the embodiments disclosed herein generally relate to prostheses for implantation within a cavity or body cavity. Specifically, some embodiments relate to expandable prostheses, such as replacement heart valves, such as those for the mitral valve, which are configured to be secured to intracavitary tissue and prevent paravalvular leak. Background Technology

[0003] The valves of the human heart, including the aortic valve, pulmonary valve, mitral valve, and tricuspid valve, essentially function as one-way valves that operate in sync with the pumping heart. Valves allow blood to flow downstream but prevent it from flowing upstream. Diseased heart valves exhibit damage, such as stenosis or regurgitation, which inhibits the valve's ability to control blood flow. This damage reduces the heart's pumping efficiency and can be a debilitating and life-threatening condition. For example, valvular insufficiency can lead to conditions such as cardiac hypertrophy and ventricular dilation. Therefore, considerable effort has been devoted to developing methods and devices to repair or replace damaged heart valves.

[0004] Prostheses exist to correct problems associated with damaged heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace damaged natural heart valves. Recently, much work has been devoted to developing replacement heart valves, particularly tissue-based replacement heart valves that can be delivered with less trauma to the patient than through open-heart surgery. Replacement valves are designed for delivery via minimally invasive procedures or even percutaneous surgery. Such replacement valves typically consist of a tissue-based valve body connected to an expandable frame, which is then delivered to the annulus of the natural valve.

[0005] These replacement valves are typically designed to at least partially impede blood flow. However, problems arise when blood flows outside the prosthesis, around the valve. For example, paravalvular leakage has proven particularly challenging in the case of heart valve replacement. Another challenge involves the ability to fix this prosthesis in a non-invasive manner relative to intracavitary tissues (such as any body cavity or intracavitary tissue). Yet another challenge arises when attempting to reduce the likelihood of thrombosis within partially replaced valves. Summary of the Invention

[0006] Embodiments of this disclosure relate to prostheses, such as, but not limited to, heart valve replacements.

[0007] In some embodiments, the replacement heart valve prosthesis may include an expandable frame. The expandable frame can expand and contract radially to be deployed within a natural heart valve. The expandable frame may have a longitudinal axis between its upper and lower ends. The expandable frame may include a first frame portion. The first frame portion may include a first frame body. The first frame body may include a first upper region, a first middle region, and / or a first lower region. The first frame portion may include a first anchoring feature. When the prosthesis is in an expanded configuration, the first anchoring feature may extend radially outward from the first lower region, and / or at least a portion of the first anchoring feature may extend toward the first upper region.

[0008] The expandable frame may include a second frame portion located radially lateral to the first frame body. The second frame portion may include the second frame body. The second frame body may include a second upper region, a second intermediate region, and / or a second lower region. When the prosthesis is in an expanded configuration, at least a portion of the second upper region may extend radially outward from the first upper region, and / or the second lower region may be radially positioned between the first anchoring structure and the first frame body. When the prosthesis is in an expanded configuration and deployed within a natural heart valve, the second intermediate portion may be positioned within the natural valve annulus.

[0009] A replacement heart valve prosthesis may include a valve body positioned within a first frame portion. The valve body may include multiple leaflets that allow flow in a first direction and prevent flow in a second, opposite direction.

[0010] When the prosthesis is in an expanded configuration, the second intermediate region may be generally cylindrical. When the prosthesis is in an expanded configuration, the second intermediate region may be generally non-cylindrical. When the prosthesis is in an expanded configuration, the diameter of the portion of the second intermediate region between its upper and lower ends may be greater than at least one of the upper and lower ends of the second intermediate region. The second intermediate region may be sized such that when the prosthesis is deployed and expanded within the natural heart valve, the second intermediate region can exert a radially outward force on the natural valve annulus. When the prosthesis is in an expanded configuration, the second lower region may be radially inwardly inclined and / or bent toward the longitudinal axis. When the prosthesis is in an expanded configuration, at least a portion of the second upper region may extend toward the first lower region. When the prosthesis is in an expanded configuration, at least a portion of the second upper region may extend toward the first lower region in a direction generally parallel to the longitudinal axis. The second frame portion and the first anchoring structure can be sized such that when the prosthesis is deployed and expanded within the natural heart valve, the natural valve leaflet and / or natural valve annulus can be clamped between the second frame portion and the first anchoring structure.

[0011] When the prosthesis is in the expanding configuration, at least a portion of the first anchoring structure may extend upward toward the first upper region. The first anchoring structure may include a first plurality of anchors. When the prosthesis is in the expanding configuration, the anchoring tips of the first plurality of anchors may extend in a direction generally parallel to the longitudinal axis. When the prosthesis is in the expanding configuration, the anchoring tips of the first plurality of anchors may extend in a direction generally perpendicular to the longitudinal axis. When the prosthesis is in the expanding configuration, at least a portion of the anchoring tips of the first plurality of anchors may extend radially inward toward the longitudinal axis. When the prosthesis is in the expanding configuration, at least a portion of the anchoring tips of the first plurality of anchors extend radially outward away from the longitudinal axis. When the prosthesis is deployed and expanded within the natural mitral valve, at least some of the first plurality of anchors may contact the natural mitral valve annulus on the ventricular side. When the prosthesis is in the expanding configuration, at least a portion of the anchoring tips of the first plurality of anchors are angled and / or bent circumferentially.

[0012] The second frame portion may include a second anchoring structure. At least a portion of the second anchoring structure may extend from at least one of the second upper region and the second intermediate region. The second anchoring structure may include a second plurality of anchor members. The anchor members among the second plurality of anchor members may be V-shaped. When the prosthesis is in an expanded configuration, the anchor members among the second plurality of anchor members may extend in a direction generally parallel to the second upper region. When the prosthesis transitions from an expanded configuration to a collapsed configuration, the ends of the anchor members of the second plurality of anchor members may move radially outward and upward. When the prosthesis transitions from an expanded configuration to a collapsed configuration, the ends of the anchor members of the second plurality of anchor members may move radially outward and downward.

[0013] The prosthesis may include a skirt extending around at least a portion of the prosthesis. At least a portion of the skirt may extend externally along the second frame portion. At least a portion of the skirt may extend internally along the second frame portion. At least a portion of the skirt may extend internally along the second frame portion and be attached to the valve body. At least a portion of the skirt may extend externally along a second intermediate region. At least a portion of the skirt may extend externally along a second upper region. At least a portion of the skirt may extend internally along the second upper region. At least a portion of the skirt is spaced apart from the second upper region.

[0014] The valve body may include a liner. The liner may extend from the arched edges of the multiple leaflets toward the upper end of the first frame body. The upper end of the liner may be located at or near the upper end of the first frame body. The upper end of the liner may be located at or near the uppermost end of the arched edges of the multiple leaflets.

[0015] The valve body may include one or more intermediate components. These one or more intermediate components may be positioned between the first frame body and the valve leaflet.

[0016] The first frame portion and the second frame portion can be separate components. The first frame portion may include a plurality of first eyelets. The second frame portion may include a plurality of second eyelets. Each of the plurality of first eyelets may correspond to a plurality of second eyelets. The first frame portion and the second frame portion may be coupled at each of the plurality of first and second eyelets. The first and second frame portions may be securely fixed at one or more attachment points such that relative movement at the one or more attachment points is suppressed. The first and second frame portions may be loosely fixed at one or more attachment points such that the first and second frame portions may move relative to each other at the one or more attachment points. The first and second frame portions may be coupled by a skirt.

[0017] The inner frame and the outer frame form an integral component.

[0018] The first frame body may include one or more rows of cells. At least one row of cells may include an upper and lower section formed by multiple undulating supports and a middle section formed by one or more openings. The first frame body may include foreshortening sections. The second frame body may include one or more rows of cells. The second frame body may include foreshortening sections. One or more portions of the first frame body may be cylindrical, bulbous, and / or truncated conical.

[0019] In some embodiments, the replacement heart valve prosthesis may include an expandable frame. The expandable frame can expand and contract radially to be deployed within the native heart valve. The expandable frame may have a longitudinal axis between its upper and lower ends. The expandable frame may include a frame body. The frame body may include an upper region, a middle region, and / or a lower region.

[0020] The expandable frame may include an upper anchoring structure, an intermediate anchoring structure, and / or a lower anchoring structure. The upper anchoring structure may extend from the upper region of the frame body. The intermediate anchoring structure may extend from the middle region of the frame body. The lower anchoring structure may extend from the lower region of the frame body. When the frame is in an expanded configuration, at least a portion of the upper anchoring structure may be located radially outward from the frame body, at least a portion of the intermediate anchoring structure may be located radially outward from the frame body, and / or at least a portion of the lower anchoring structure may be located radially outward from the frame body.

[0021] A replacement heart valve prosthesis may include a valve body positioned within a first frame portion. The valve body may include multiple leaflets that allow flow in a first direction and prevent flow in a second, opposite direction.

[0022] The intermediate anchoring structure can be sized such that, when the prosthesis is deployed and expanded within the natural heart valve, the second anchoring structure applies a radially outward force to the natural valve annulus. When the prosthesis is in an expanded configuration, at least a portion of the intermediate anchoring structure can be radially positioned between the frame body and the lower anchoring structure. The intermediate and lower anchoring structures can be sized such that, when the prosthesis is deployed and expanded within the natural heart valve, the natural valve leaflet and / or natural valve annulus can be sandwiched between the intermediate and lower anchoring structures. The intermediate anchoring structure may include a braided mesh.

[0023] The main frame and the intermediate anchoring structure can be separate components. Alternatively, the main frame and the intermediate anchoring structure can be combined to form a single, integrated component.

[0024] When the prosthesis is in an expanded configuration, at least a portion of the upper anchoring structure may extend radially outward away from the longitudinal axis. When the prosthesis is in an expanded configuration, at least a portion of the upper anchoring structure may extend radially inward toward the longitudinal axis. The upper anchoring structure may include multiple upper anchoring elements.

[0025] When the prosthesis is in an expanded configuration, at least a portion of the lower anchoring structure may extend radially outward away from the longitudinal axis. When the prosthesis is in an expanded configuration, at least a portion of the lower anchoring structure may extend upward toward the upper anchoring structure. The lower anchoring structure may be attached to the frame body above the lower end of the lower region. The lower anchoring structure may include a plurality of lower anchors. When the prosthesis is in an expanded configuration, the anchor ends of the plurality of lower anchors extend in a direction generally parallel to the longitudinal axis. When the prosthesis is in an expanded configuration, the anchor ends of the plurality of lower anchors may extend in a direction generally perpendicular to the longitudinal axis. When the prosthesis is in an expanded configuration, at least a portion of the anchor ends of the plurality of lower anchors may extend radially inward toward the longitudinal axis. When the prosthesis is in an expanded configuration, at least a portion of the anchor ends of the plurality of lower anchors may extend radially outward away from the longitudinal axis. The anchors of the lower plurality of anchors can be sized such that, when the prosthesis is deployed and dilated within the natural mitral valve, at least some of the lower plurality of anchors can contact the natural mitral valve annulus on the ventricular side. At least some of the lower plurality of anchors can be angled and / or bent in the circumferential direction.

[0026] A replacement heart valve prosthesis may include a skirt extending around at least a portion of the prosthesis. At least a portion of the skirt may extend radially outward outside of an upper anchoring structure. At least a portion of the skirt may extend radially inward inside the upper anchoring structure. At least a portion of the skirt may extend radially outward outside of an intermediate anchoring structure. At least a portion of the skirt may extend between the intermediate and lower anchoring structures. At least a portion of the skirt may be coupled to an upper region of a frame. At least a portion of the skirt may be coupled to the frame below the intermediate anchoring structure and above the lower anchoring structure. At least a portion of the skirt may be coupled to the valve body. At least a portion of the skirt may be coupled to the liner of the valve body.

[0027] The main body of the frame may include one or more lines of cells. The first main body of the frame may include a shortened portion.

[0028] In some embodiments, the replacement heart valve prosthesis may include an expandable frame. The expandable frame can expand and contract radially to be deployed within a natural heart valve. The expandable frame may have a longitudinal axis between its upper and lower ends. The expandable frame may include a frame body. The frame body may include an upper region, a middle region, and / or a lower region. The expandable frame may include an anchoring structure. The anchoring structure may extend from the upper region of the frame body. The upper anchoring structure may include an anchor body formed of wire mesh. When the prosthesis is in an expanded configuration, at least a portion of the anchor body may extend radially outward from the frame body.

[0029] The anchoring body may be formed of a braided tube. The anchoring body may conform to the shape of the natural heart valve. When the prosthesis is deployed and dilated within the natural mitral valve, at least a portion of the anchoring body may be positioned within the valve annulus and may apply a radially outward force to the natural mitral valve annulus. When the prosthesis is deployed and dilated within the natural mitral valve, at least a portion of the anchoring body may be positioned in the left atrium and may extend on the atrial surface of the natural valve annulus. When the prosthesis is deployed and dilated within the natural mitral valve, at least a portion of the anchoring body may be positioned in the left ventricle and may apply a radially outward force to the natural leaflet. The anchoring structure may include one or more barbs.

[0030] The anchoring structure may include one or more arms extending from the upper region of the frame body and / or the anchor body. These arms may be formed of wire mesh. When the prosthesis is in an expanding configuration, these arms may extend radially outward from the frame body. When the prosthesis is in an expanding configuration, these arms may extend upward away from the frame body. When the prosthesis is deployed and expanded within the natural mitral valve, these arms may contact a portion of the atrial wall.

[0031] In some embodiments, the replacement heart valve prosthesis may include an expandable frame. The expandable frame can expand and contract radially to be deployed within a natural heart valve. The expandable frame may have a longitudinal axis between its upper and lower ends. The expandable frame may include a first frame portion. The first frame portion may include a first frame body. The first frame body may include a first upper region, a first middle region, and / or a first lower region. The first frame portion may include a first anchoring structure. When the prosthesis is in an expanded configuration, the first anchoring structure may be attached to the first frame body at its base along a first distal region, and / or at least a portion of the first anchoring structure may extend toward the first upper region.

[0032] The expandable frame may include a second frame portion located radially lateral to the first frame body. The second frame portion may include a second frame body. The second frame body may include a second upper region, a second intermediate region, and / or a second lower region. When the prosthesis is in an expanded configuration, at least a portion of the second lower region is located below the base, at least a portion of the second lower region is radially positioned between the first anchoring structures, and / or the second lower region extends radially outward from the first lower region. When the prosthesis is in an expanded configuration and deployed within a natural heart valve, the second intermediate portion may be positioned within the natural valve annulus.

[0033] A replacement heart valve prosthesis may include a valve body positioned within a first frame portion. The valve body may include multiple leaflets that allow flow in a first direction and prevent flow in a second, opposite direction.

[0034] When the prosthesis is in an expanded configuration, the second intermediate region can be generally cylindrical. When the prosthesis is in an expanded configuration, the second intermediate region is generally non-cylindrical. The second intermediate region can be sized such that when the prosthesis is deployed and expanded within the native heart valve, the second intermediate region exerts a radially outward force on the native valve annulus. The second frame portion and the first anchoring structure can be sized such that when the prosthesis is deployed and expanded within the native heart valve, at least one of the native valve leaflet and the native valve annulus is sandwiched between the second frame portion and the first anchoring structure.

[0035] The first anchoring structure may include a first plurality of anchors. When the prosthesis is in an expanded configuration, the anchor ends of the first plurality of anchors may extend in a direction generally parallel to the longitudinal axis. The first plurality of anchors may be sized such that, when the prosthesis is deployed and expanded within the natural mitral valve, at least some of the first plurality of anchors contact the natural mitral valve annulus on the ventricular side.

[0036] The second frame portion may include a second anchoring structure. The second anchoring structure may include a second plurality of anchors. The anchors of the second plurality of anchors may be V-shaped. When the prosthesis transitions from an expanded configuration to a contracted configuration, the anchors of the second plurality of anchors may extend radially outward and upward. When the prosthesis transitions from an expanded configuration to a contracted configuration, the anchors of the second plurality of anchors may extend radially outward and downward.

[0037] The replacement heart valve may include a skirt extending around at least a portion of the prosthesis. At least a portion of the skirt may extend along the exterior of the second frame portion. At least a portion of the skirt may extend along the interior of the second frame portion.

[0038] The valve body may include one or more intermediate components. These one or more intermediate components may be positioned between the first frame body and the valve leaflet.

[0039] The first frame portion and the second frame portion can be separate components. The first frame portion may include a plurality of first holes. The second frame portion may include a plurality of second holes. Each of the plurality of first holes may correspond to a plurality of second holes. The first frame portion and the second frame portion may be coupled at each of the plurality of first and second holes.

[0040] The first frame and the second frame can form an integral component.

[0041] The first frame body may include one or more rows of units. One or more portions of the first frame body may be cylindrical, bulbous, and / or truncated conical.

[0042] In some embodiments, a replacement heart valve prosthesis may include a valve body comprising three flexible leaflets. The flexible leaflets may be made of pericardium. The prosthesis may include a self-expanding metallic support structure surrounding and supporting the valve body. The support structure may be sized for deployment in a natural mitral valve.

[0043] The support structure may include a valve frame having upper, middle, and lower portions. The support structure may include multiple anchors coupled to the lower portion of the valve frame. Each anchor may extend radially outward and / or upward.

[0044] The support structure may include a sealing frame. The sealing frame may be coupled to and disposed radially outward of the valve frame. The sealing frame may have an upper, middle, and lower portion. A gap may be provided between the sealing frame and the valve frame. Multiple anchors may have ends disposed radially outward of the sealing frame.

[0045] The upper part of the sealing frame can be coupled to the upper part of the valve frame. The upper part of the sealing frame can be sutured to the upper part of the valve frame. The sealing frame can be more flexible than the valve frame to conform to the mitral valve annulus. The support structure can be adapted to capture the natural mitral valve leaflet between the sealing frame and the anchor.

[0046] The diameter of the middle portion of the sealing frame can range from approximately 35 mm to 55 mm. At least a portion of the sealing frame can be covered by fabric. The lower portion of the sealing frame can have a larger diameter than the upper portion. The middle portion of the sealing frame can have a larger diameter than the lower portion.

[0047] The sealing frame may be convex. At least a portion of the sealing frame may be generally truncated conical. For example, the upper and / or lower portion of the sealing frame may be generally truncated conical. At least a portion of the sealing frame may be generally cylindrical. For example, at least the middle portion of the sealing frame may be generally cylindrical.

[0048] The valve frame can be bulbous. The diameter of the central portion of the valve frame can be smaller than the diameter of the central portion of the sealing frame. The diameter of the central portion of the valve frame can range from approximately 28 mm to approximately 32 mm.

[0049] The anchoring structure can be axially and / or radially offset or compressible. The tip of the anchoring structure can be formed from one or more wires. The wires can be looped to form an overall three-dimensional teardrop shape. The wires can be spiraled to form an overall three-dimensional conical shape. The tip of the anchoring structure can be serpentine. The tip of the anchoring structure can be formed from one or more shortened units. Attached Figure Description

[0050] These and other features, aspects and advantages are described below with reference to the accompanying drawings, which are intended to illustrate embodiments of the prosthesis, including embodiments of various components of the prosthesis.

[0051] Figure 1 This is a side cross-sectional schematic diagram of an embodiment of a prosthesis having an inner frame, an outer frame, a valve body, and a skirt.

[0052] Figure 2 This is a top perspective view of another embodiment of a prosthesis having an inner frame, an outer frame, a valve body, and a skirt.

[0053] Figure 3 yes Figure 2 A bottom-view three-dimensional diagram of the prosthesis.

[0054] Figure 4 yes Figure 2 A top view of the prosthesis.

[0055] Figure 5yes Figure 2 The bottom view of the prosthesis.

[0056] Figure 6 yes Figure 2 A bottom-view three-dimensional view of the inner frame and valve body.

[0057] Figure 7 This is a side view of the front half of another embodiment of the outer frame.

[0058] Figure 8 yes Figure 2 Top view of the outer frame.

[0059] Figure 9 This is a side view of the front half of another embodiment of the inner frame.

[0060] Figure 10 yes Figure 2 A top view of the inner frame.

[0061] Figure 11A-11K This is a side view of another embodiment of a prosthesis having an inner frame and an outer frame.

[0062] Figure 12 This is a side view of an embodiment of a prosthesis having a frame body, a mesh anchoring structure, and a valve body.

[0063] Figure 13 yes Figure 12 A top view of the prosthesis.

[0064] Figure 14 yes Figure 12 The bottom view of the prosthesis.

[0065] Figure 15 This is a side cross-sectional schematic diagram of an embodiment of a prosthesis having a frame, a mesh anchoring structure, a valve body, and a skirt.

[0066] Figure 16 This is a top perspective view of an embodiment of a prosthesis in a partially assembled state, comprising a frame, a mesh anchoring structure, a valve body, and a skirt.

[0067] Figure 17 yes Figure 16 Enlarged lateral cross-sectional view of the prosthesis.

[0068] Figure 18 yes Figure 16 A side view of the frame and mesh anchoring structure.

[0069] Figure 19 yes Figure 16 Top-view 3D view of the framework.

[0070] Figure 20This is a side view of another embodiment of a prosthesis having a frame, valve body, woven seal, and skirt in a partially assembled configuration.

[0071] Figure 21 It is in the assembly configuration Figure 20 A side view of an embodiment of the prosthesis.

[0072] Figure 22 yes Figure 21 A top perspective view of another implementation of the framework.

[0073] Figure 23 This is a side view of an embodiment of a frame portion having a circumferentially curved anchoring structure.

[0074] Figure 24 It is located between the chordae tendineae of the heart. Figure 23 A side view of the frame section.

[0075] Figure 25 This is a side view of another embodiment of a frame portion having a circumferentially curved anchoring structure.

[0076] Figure 26 It is a planar cut pattern of another embodiment of a frame with a circumferential bending anchoring structure.

[0077] Figure 27 It is in an expanded configuration Figure 26 Side view of the frame portion.

[0078] Figure 28-30 illustrates the area located inside the heart. Figure 1 A schematic diagram of the prosthesis, in which Figure 28A -B illustrates an in-situ prosthesis in which the distal anchor contacts the ventricular side of the mitral valve annulus. Figure 29 Examples include in-situ prostheses in which the distal anchor does not contact the ventricular side of the mitral valve annulus, and Figure 30 An example is given of an in situ prosthesis in which the distal anchor does not extend between the chordae tendineae.

[0079] Figure 31 This is a cross-sectional view of the distal end of a delivery system embodiment that carries a prosthesis.

[0080] Figure 32 This is a cross-sectional view of the distal end of another embodiment of a delivery system that carries a prosthesis.

[0081] Figure 33 This is a side cross-sectional schematic diagram of another embodiment of a prosthesis having an inner frame, an outer frame, a valve body, and a skirt.

[0082] Figure 34This is a top perspective view of another embodiment of a prosthesis having an inner frame, an outer frame, a valve body, and a skirt.

[0083] Figure 35 yes Figure 34 The bottom view of the prosthesis.

[0084] Figure 36 This is a top perspective view of another implementation of the inner frame.

[0085] Figure 37 This is a top perspective view of another implementation of the outer frame.

[0086] Figure 38A This is a side cross-sectional schematic diagram of another embodiment of a prosthesis having an inner frame, an outer frame, a valve body, and a skirt.

[0087] Figure 38B yes Figure 38A A schematic diagram of the lateral cross-section of the prosthesis in a natural mitral valve.

[0088] Figure 39 This is a top perspective view of another embodiment of a prosthesis having an inner frame, an outer frame, a valve body, and a skirt.

[0089] Figure 40 yes Figure 39 A top view of the prosthesis.

[0090] Figure 41 yes Figure 39 A bottom-view three-dimensional diagram of the prosthesis.

[0091] Figure 42 yes Figure 39 Side view of the front half of the inner frame.

[0092] Figure 43 This is a top perspective view of another implementation of the outer frame.

[0093] Figure 44 This is a top perspective view of another embodiment of a prosthesis having an inner frame, an outer frame, a valve body, and a skirt.

[0094] Figure 45 This is a bottom-view perspective view of another embodiment of a prosthesis having an inner frame, an outer frame, a valve body, and a skirt.

[0095] Figure 46 This is a side cross-sectional schematic diagram of another embodiment of a prosthesis having an inner frame, an outer frame, a valve body, and a skirt.

[0096] Figure 47 yes Figure 46 A lateral cross-sectional view of the prosthesis illustrates the commissure of the leaflets.

[0097] Figure 48 This is a side view of an implementation of the anchoring structure.

[0098] Figure 49 This is a side view of another embodiment of the anchoring structure.

[0099] Figure 50 This is a side view of an implementation of the anchoring structure.

[0100] Figure 51 This is a side view of another embodiment of the anchoring structure.

[0101] Figure 52 This is a side view of an implementation of the anchoring structure.

[0102] Figure 53 This is a side view of another embodiment of the anchoring structure.

[0103] Figure 54A-57H A schematic diagram illustrating a delivery procedure utilizing the prosthesis and delivery system described herein is provided.

[0104] Figure 58 and 59 A schematic diagram illustrating an implementation of a prosthesis positioned within the heart is provided. Detailed Implementation

[0105] This specification and accompanying drawings provide aspects and features of this disclosure within the context of several embodiments configured for use in a patient's vascular system, such as prostheses for replacing a patient's natural heart valves, heart valve replacements, and methods. These embodiments may be discussed in conjunction with the replacement of a specific valve, such as a patient's mitral valve. However, it should be understood that the features and ideas discussed herein are applicable to the replacement of other types of valves, including but not limited to aortic, pulmonary, and tricuspid valves. Moreover, it should be understood that the features and ideas discussed herein are applicable to products other than heart valve implants. For example, the controlled positioning, deployment, and / or fixation features described herein are applicable to medical implants, such as other types of expandable prostheses, for use elsewhere in the body, such as within a vein. Furthermore, specific features of the prosthesis should not be considered limiting, and features of any embodiment discussed herein may be combined with features of other embodiments as needed and where appropriate.

[0106] Certain terminology may be used in the following description for illustrative purposes only and is not intended to be limiting. For example, terms such as “up,” “down,” “above,” “below,” “top,” “bottom,” “top,” “bottom,” and similar terms refer to orientation in the accompanying drawings. Terms such as “proximal,” “farthest,” “radially outward,” “radially inward,” “outer,” “inner,” and “side” describe the orientation and / or position of a part or element in a consistent but arbitrary frame of reference, which becomes clear by reference to the text describing the part or element under discussion and the associated drawings. Such terminology may include the words specifically mentioned above, their derivatives, and words with similar meanings. Similarly, unless the context clearly indicates otherwise, the terms “first,” “second,” and other such numerical terms relating to structures do not imply order or sequence.

[0107] In some implementations, the term "proximal" may refer to the portion or component of the prosthesis located closer to the operator (e.g., the clinician implanting the prosthesis) of the device and system. The term "distal" may refer to the portion or component of the prosthesis located further away from the device and system (e.g., the clinician implanting the prosthesis). However, it should be understood that this terminology may be reversed depending on the delivery technique used (e.g., transapical approach versus transseptal approach). In some cases, the prosthesis or its components may be oriented such that the upper end is the proximal portion and the lower end is the distal portion.

[0108] In some cases, the upper end of a prosthesis or its components can be an inflow end, and the lower end can be an outflow end. For example, a valve body used with a prosthesis may allow flow from the upper end to the lower end. However, it should be understood that the inflow and outflow ends can be reversed. For example, a valve body used with a prosthesis may allow flow from the lower end to the upper end.

[0109] The longitudinal axis of a prosthesis or its components can be defined as a central axis extending between the upper and lower ends of the prosthesis or component (e.g., a prosthesis, an outer frame, and / or an inner frame) and passing through the center of the prosthesis or component. The prosthesis described herein can be a replacement valve, which can be designed to replace a damaged or diseased natural heart valve, such as the mitral valve, as described above. It should be understood that the prosthesis is not limited to a replacement valve.

[0110] As described in further detail below, the prosthesis may include an inner frame and / or an outer frame. In some embodiments, the inner frame may be a valve frame designed to support the valve body. In some embodiments, the outer frame may be a sealing frame designed to form a seal around the periphery of the outer frame. For example, the outer frame may engage with and form a seal with body cavity tissue around the periphery of the outer frame. In some embodiments described herein, the outer frame may be attached to the inner frame at one or more fixation couplers, such that the outer frame is secured to the inner frame at one or more locations. It should be understood that the outer frame may be attached to the inner frame via one or more movable couplers, such as, but not limited to, tracks. This can advantageously allow the outer frame to be adjusted relative to the inner frame to better conform to the anatomy of the patient's body cavity.

[0111] The inner and / or outer frame can be described as having a superior region, a middle region, and a inferior region. In some cases, such as those where the prosthesis is positioned within a natural mitral valve, the superior region may be generally positioned above the annulus (i.e., above the annular plane), the middle region may be generally positioned within the annulus (i.e., within the annular plane), and the inferior region may be positioned below the annulus (i.e., below the annular plane). However, it should be understood that in some cases, the positioning of the inner and / or outer frame relative to the annulus may differ. Furthermore, it should be understood that in some embodiments, one or more of the superior, middle, and / or inferior regions of the inner and / or outer frame may be omitted.

[0112] While this document describes certain combinations of inner and outer frames, it should be understood that the inner and outer frames are interchangeable. This can advantageously allow the prosthesis to be configured in a way that better fits the patient's natural anatomy. Furthermore, while the inner and outer frames can be attached prior to delivery into the patient, it should be understood that they can also be delivered separately and subsequently attached within the patient. This can advantageously reduce the fold profile when delivering the frames into the body cavity. The prosthesis described herein can be used as a stand-alone device. For example, the prosthesis can be deployed at the natural mitral valve and appropriately sized and shaped to replace the function of the natural mitral valve. However, it should be understood that the prosthesis described herein can be used in conjunction with other devices. For example, one or more clamps can be used to converge the natural leaflets of the heart valve. This can advantageously allow the use of a smaller prosthesis at the natural mitral valve.

[0113] Implementation methods of valve and frame replacement

[0114] refer to Figure 1This document illustrates an embodiment of a prosthesis 100 in an expanded configuration. The prosthesis 100 may include an inner frame 120, an outer frame 140, a valve body 160, and a skirt 180. The longitudinal axis 102 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 cases, the prosthesis 100 may be oriented such that its upper end is the proximal portion and its lower end is the distal portion. The illustrated prosthesis 100, as well as other prostheses described herein, may include self-expanding or balloon-expanding components. For example, in some embodiments, the inner frame 120 and / or the outer frame 140 may be self-expanding. The prosthesis 100, as well as other prostheses described herein, may be a replacement valve, which may be designed to replace a damaged or diseased natural heart valve, such as the mitral valve, as described above. It should be understood that the prosthesis 100, as well as other prostheses described herein, is not limited to replacement valves.

[0115] First refer to Figure 1 The inner frame 120 shown can provide a structure for attaching various components of the prosthesis 100. The inner frame 120 may include an inner frame body 122 and an inner frame anchoring structure 124. 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 diameters of the upper region 126, the middle region 128, and the lower region 130 are generally equal. However, it should be understood that the diameters of the upper region 126, the middle region 128, and / or the lower region 130 may be different. For example, in some embodiments, the diameter of the middle region 128 may be larger than that of the upper region 126 and the lower region 130, such that the frame body 122 has a generally bulbous shape. In some embodiments, the diameter of the lower region 130 may be larger than the diameter of the upper region 126. In other embodiments, the diameter of the upper region 126 may be larger than the diameter of the lower region 130. Furthermore, although the inner frame body 122 has been described and exemplified as cylindrical or having a circular cross-section, it should be understood that all or part of the inner frame body 122 may have a non-circular cross-section, such as, but not limited to, D-shaped, elliptical, or other oval cross-sectional shapes.

[0116] In some cases, such as when the prosthesis 100 is positioned within the natural mitral valve, the upper region 126 may be generally positioned above the annulus (i.e., above the annular plane), the middle region 128 may be generally positioned within the annulus (i.e., within the annular plane), and the lower region 130 may be positioned below the annulus (i.e., below the annular plane). However, it should be understood that in some cases, the positioning of the inner frame 120 relative to the annulus may differ. Furthermore, it should be understood that in some embodiments, one or more of the upper region 126, the middle region 128, and / or the lower region 130 may be omitted from the inner frame 120.

[0117] As shown in the example embodiment, the inner frame anchoring structure 124 may generally extend downward and / or radially outward at or near the lower end of the lower region 130 of the inner frame body 122. The inner frame anchoring structure 124 may extend upward toward one end of the inner frame anchoring structure 124. As will be discussed in further detail below, components of the inner frame 120, such as the inner frame anchoring structure 124, may be used to attach or secure the prosthesis 100 to the natural valve. For example, in some cases, the inner frame anchoring structure 124 may be used to attach or secure the prosthesis 100 to the natural mitral valve. In such embodiments, the inner frame anchoring structure 124 may be positioned to contact or engage the natural mitral valve annulus on the ventricular side, ventricular tissue extending beyond the natural valve annulus, the natural leaflet on the ventricular side, and / or other tissue at or around the implantation site during one or more phases of the cardiac cycle, such as systole and / or diastole. When positioned within the natural mitral valve, the inner frame anchoring structure 124 can advantageously eliminate, inhibit, or limit the upward movement of the prosthesis 100 when subjected to upward forces (such as those applied to the prosthesis 100 during systole).

[0118] The inner frame 120 can be formed of a variety of different materials, including but not limited to shape memory metals such as nitinol. The inner frame 120 can be formed of multiple struts forming the opening unit. In some embodiments, the inner frame 120 may have a relatively rigid construction compared to other components of the prosthesis 100 (including but not limited to the outer frame 140). This can be achieved, for example, through the size and configuration of the struts. A relatively rigid construction can better resist deformation when subjected to stress. This can be advantageous during certain portions of the cardiac cycle, such as systole, during which the inner frame 120 can withstand significant stress on the inner frame anchoring structure 124. A relatively rigid construction 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, a relatively rigid construction can be advantageous when the inner frame 120 is used in a valve-in-valve procedure, where a supplementary prosthesis is positioned within the inner frame 120. However, while the inner frame 120 has been described as having a relatively rigid construction, it should be understood that in some embodiments, the inner frame 120 may have a relatively flexible construction. For example, the inner frame 120 may have a construction that is approximately as flexible as or more flexible than other components of the prosthesis 100, such as the outer frame 140.

[0119] The inner frame 120 may share features such as structure and / or function that are the same as or at least similar to those of other frames described herein (such as, but not limited to, frames 220, 400, 520a-k, 620, 720, 820, 920, 1000, 1100, 1202, 1520, 1620, 1700, 1920, 2020, 2220, 2320, 2420, 2910, 3010, 3110, and 3210 discussed below). The inner frame 120 and any other frame described herein may include features and concepts similar to those disclosed in U.S. Patent Nos. 8,403,983, 8,414,644, and 8,652,203, U.S. Publications Nos. 2011 / 0313515, 2014 / 0277390, 2014 / 0277427, 2014 / 0277422, and 2015 / 0328000, and U.S. Application No. 15 / 653,390 entitled “REPLACEMENT HEART VALVE PROSTHESIS”, filed July 18, 2017 (the entire contents of which are incorporated herein by reference and form part of this specification). This includes the entire disclosure and is not in any way limited to the disclosure of the relevant frame. Furthermore, although the inner frame 120 has been described as including the inner frame body 122 and the inner frame anchoring structure 124, it should be understood that the inner frame 120 need not include all components. For example, in some embodiments, the inner frame 120 may include an inner frame body 122, while omitting the inner frame anchoring structure 124. Furthermore, although the inner frame body 122 and the inner frame anchoring structure 124 have been exemplified as being integrally or monolithically formed, it should be understood that in some embodiments, the inner frame body 122 and the inner frame anchoring structure 124 may be formed separately. In such embodiments, any of the fasteners and / or techniques described herein can be used to attach the individual components. For example, the inner frame anchoring structure 124 may be formed separately from the inner frame body 122 and may be attached to the inner frame body 122.

[0120] Next reference Figure 1The outer frame 140 shown herein can provide a structure for attaching various components of the prosthesis 100. The outer frame 140 can be attached to the inner frame 120 using any fasteners and / or techniques described herein, including but not limited to mechanical fasteners such as stitches, U-bolts, screws, rivets, connecting members (e.g., tabs and slots that may be located on the inner frame 120 and outer frame 140), and any other desired type of mechanical fastener; chemical fasteners such as adhesives and any other desired type of chemical fastener; fastening techniques such as welding, soldering, sintering, and any other desired type of fastening technique; and / or combinations of such fasteners and techniques. The inner frame 120 and outer frame 140 can be indirectly attached via an intermediate component (such as a skirt 180).

[0121] The outer frame 140 may be attached to the inner frame 120 at one or more attachment points. As will be described in further detail, the outer frame 140 may be attached tautly to the inner frame 120 such that little or no relative movement between the outer frame 140 and the inner frame 120 occurs at the one or more attachment points. In other embodiments, the outer frame 140 may be loosely attached to the inner frame 120 such that some relative movement between the outer frame 140 and the inner frame 120 may occur at the one or more attachment points. Although the outer frame 140 is exemplified as a separate component from the inner frame 120, it should be understood that the frames 120 and 140 may be formed integrally or monolithically.

[0122] As shown in the example embodiments, the outer frame 140 may include an outer frame body 142 and an outer frame anchoring structure 144. The outer frame body 142 may have an upper region 146, a middle region 148, and a lower region 150. In some cases, such as those where the prosthesis 100 is positioned within a natural mitral valve, the upper region 146 may be generally positioned on the annulus, the middle region 148 may be generally positioned within the annulus, and the lower region 150 may be positioned below the annulus. However, it should be understood that in some cases, the positioning of the outer frame 140 relative to the valve annulus may differ. Furthermore, it should be understood that in some embodiments, one or more of the upper region 146, the middle region 148, and / or the lower region 150 may be omitted from the outer frame 140.

[0123] When in an expanded configuration, such as a fully expanded configuration, the outer frame body 142 can have an enlarged shape, wherein the middle region 148 and the lower region 150 are larger than the upper region 146. The enlarged shape of the outer frame body 142 advantageously allows it to engage with the natural valve annulus, natural valve leaflet, or other tissues in the body cavity, while simultaneously isolating the upper end from the heart or blood vessel wall. This can help reduce undesirable contact between the prosthesis 100 and the heart or blood vessels (such as the atrioventricular walls of the heart).

[0124] The upper region 146 of the outer frame body 122 may include a generally longitudinally extending portion 146a and an outwardly extending portion 146b. The longitudinally extending portion 146a may be generally concentric with the inner frame body 122. The outwardly extending portion 146b may extend radially outward away from the longitudinal axis 102 of the prosthesis 100. The outwardly extending portion 146b may extend from the longitudinally extending portion 146a in a direction more perpendicular to the longitudinal axis 102 than parallel and / or downward. However, it should be understood that the outwardly extending portion 146b may extend from the longitudinally extending portion 146a generally perpendicular to the longitudinal axis 102 and / or in an upward direction. Moreover, it should be understood that the longitudinally extending portion 146a may be omitted, such that the upper region 146 extends radially outward at its upper end.

[0125] The middle region 148 of the outer frame body 142 can generally extend downward from the outwardly extending portion 146b of the upper region 146. As shown, the middle region 148 can have a generally constant diameter from the upper end to the lower end of the middle region 148, such that the middle 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 in between can be different. For example, the diameter of the portion between the upper and lower ends can be larger than that of the upper and lower ends, such that the middle region 148 has 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.

[0126] The lower region 150 of the outer frame body 142 can generally extend downward from the lower end of the intermediate region 148. As shown, the lower region 150 of the outer frame body 142 can have a generally constant diameter from the upper end to the lower end of the lower region 150, such that the lower region 150 forms a generally cylindrical shape. However, it should be understood that the diameters of the upper end, the lower end, and / or portions therein can be different. For example, in some embodiments, the diameter of the upper end of the lower region 150 can be larger than the diameter of the lower end of the lower region 150, such that the lower region 150 extends radially inward toward the longitudinal axis 102 of the prosthesis 100. In some embodiments, the diameter of the lower end can be larger than the diameter of the upper end.

[0127] As shown, the diameters of the intermediate region 148 and the lower region 150 are generally equal, such that the intermediate region 148 and the lower region 150 together form an overall cylindrical shape. However, it should be understood that the diameters of the intermediate region 148 and the lower region 150 may be different. For example, the diameter of the lower region 150 may be smaller than the diameter of the intermediate region 148. Furthermore, although the outer frame body 142 has been described and exemplified as cylindrical or having a circular cross-section, it should be understood that all or part of the outer frame body 142 may have a non-circular cross-section, such as, but not limited to, D-shaped, elliptical, or other oval cross-sectional shapes.

[0128] Continue to refer to Figure 1 The outer frame 140 shown has an outer frame anchoring structure 144 that extends outward relative to the longitudinal axis 102 of the prosthesis 100. The outer frame anchoring structure 144 may extend at or near the juncture between the upper region 146 and the middle region 148 of the outer frame body 142. The outer frame anchoring structure 144 may extend in a direction more perpendicular to the longitudinal axis 102 than parallel, and / or may extend downward from the longitudinal extension portion 146a. As shown, the outer frame anchoring structure 144 may extend in a direction generally aligned with the outward extension portion 146b of the upper region 146. However, it should be understood that the outer frame anchoring structure 144 may generally be perpendicular to the longitudinal axis 102 and / or extend upward.

[0129] As will be discussed in further detail below, components of the outer frame 140, such as the outer frame body 142, can be used to attach or secure the prosthesis 100 to a natural valve, such as the natural mitral valve. For example, the central region 148 of the outer frame body 142 and / or the external anchoring structure 144 can be positioned to contact or engage the natural valve annulus, tissue beyond the natural valve annulus, natural leaflets, and / or other tissue at or around the implantation site during one or more phases of the cardiac cycle, such as systole and / or diastole. When the outer frame body 142 is positioned within the natural mitral valve, the outer frame body 142 can advantageously eliminate, suppress, 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 may be sized and positioned relative to the inner frame anchoring structure 124 such that body cavity tissue, such as natural valve leaflets and / or natural valve annulus, positioned between the outer frame body 142 and the inner frame anchoring structure 124, can be engaged or clamped to further secure the prosthesis 100 to the tissue. For example, the lower region 150 of the outer frame body 142 may be positioned at or near the tip or end of the inner frame anchoring structure 124. As shown, the lower region 150 of the outer frame body 142 is positioned such that at least a portion is located radially inward and below the inner frame anchoring structure 124. In some embodiments, portions of the outer frame 140, such as the lower region 150, may be secured by one or more tethers or sutures (e.g., Figure 45 The outer frame 140 (as shown) is attached to the inner frame body 122 to limit the outward extension of the outer frame 140 relative to the inner frame body 122. This can advantageously hold a portion of the outer frame 140 between the inner frame body 122 and the inner frame anchoring structure 124. Although the inner frame anchoring structure 124 is shown to extend from the inner frame body 122, it should be understood that such anchoring structure can extend from the outer frame body 140.

[0130] The use of the inner frame 120 and outer frame 140 is advantageous for prosthesis design because the inner frame 120 can be designed to fit the structure of the valve body 160, and the outer frame 140 can be designed to fit the anatomy of the body cavity to which the prosthesis 100 is applied. For example, the valve body 160 may be cylindrical and have a diameter smaller than the body cavity. In such embodiments, the inner frame 120 may advantageously have a smaller shape and / or size to support the valve body 160, while the outer frame 140 may have a larger shape and / or size to secure the prosthesis 100 to the body cavity. Furthermore, in embodiments where the outer frame 140 is larger than the inner frame 120, the shape of the outer frame 140 may advantageously enhance hemodynamic performance. For example, the shape of the outer frame 140, having a larger, generally cylindrical central region 148, may allow for significant washout below the valve body 160. This washout may advantageously reduce the risk of thrombus or clot formation below and around the valve body 160.

[0131] The outer frame 140 can be formed from a variety of different materials, including but not limited to shape memory metals such as nitinol. The outer frame 140 can be formed from multiple struts forming openings. In some embodiments, the outer frame 140 can have a more flexible construction compared to other components of the prosthesis 100 (such as, but not limited to, the inner frame 120). This can be achieved, for example, through the size and configuration of the struts. For example, fewer struts, thinner struts, and / or different strut materials can be used. A more flexible construction allows the outer frame 140 to better conform to the anatomical structures of the body cavity, such as natural valve annulus and / or natural leaflets. This is beneficial for anchoring against the body cavity and / or forming a seal against the body cavity. However, it should be understood that in some embodiments, the outer frame 140 can have a structure that is as rigid as or more rigid than other components of the prosthesis 100 (such as the inner frame 120).

[0132] The outer frame 140 may share features such as structure and / or function that are the same as or at least similar to those of other frames described herein (such as, but not limited to, frames 240, 300, 540a-k, 560h, 1204, 1540, 1640, 1800, 1940, 2040, 2100, 2240, 2340, 2440, 2920, 3020, 3120, and 3220 discussed below). The outer frame 140 and any other frame described herein may include features and concepts similar to those disclosed in U.S. Patent Nos. 8,403,983, 8,414,644, and 8,652,203, U.S. Publications Nos. 2011 / 0313515, 2014 / 0277390, 2014 / 0277427, 2014 / 0277422, and 2015 / 028000, and U.S. Application No. 15 / 653,390 entitled “REPLACEMENT HEART VALVE PROSTHESIS”, filed July 18, 2017 (the entire contents of which are incorporated herein by reference). Furthermore, although the outer frame 140 has been described as including an outer frame body 142 and an outer frame anchoring structure 144, it should be understood that the outer frame 140 need not include all components. For example, in some embodiments, the outer frame 140 may include the outer frame body 142 while omitting the outer frame anchoring structure 144. Furthermore, although the outer frame body 142 and the outer frame anchoring structure 144 have been exemplified as being integrally or monolithically formed, it should be understood that in some embodiments, the outer frame body 142 and the outer frame anchoring structure 144 may be formed separately. In such embodiments, any of the fasteners (agents) and techniques described herein can be used to attach the individual components. For example, the outer frame anchoring structure 144 may be formed separately from the outer frame body 142 and may be attached to the outer frame body 142.

[0133] Next reference Figure 1 The valve body 160 shown can be attached to the inner frame 120 inside the inner frame 120. The valve body 160 can act as a one-way valve, allowing blood flow through the valve body 160 in a first direction and inhibiting blood flow through the valve body 160 in a second direction. For example, when the upper end of the prosthesis 100 is proximal and the lower end of the prosthesis 100 is distal, the valve body 160 can allow blood flow in a proximal-to-distal direction and inhibit blood flow in a distal-to-proximal direction. The valve body 160 may include a plurality of leaflets 162, such as three leaflets 162, joined at a junction. The leaflets 162 may be formed of biocompatible materials, including but not limited to pericardial and / or synthetic materials.

[0134] The valve body 160 may include a liner 164. The liner 164 may be used to assist fluid flow through and / or around the prosthesis 100, such as through and around the inner frame 120 and leaflets 162. The liner 164 may surround at least a portion of the leaflets 162 and be attached to one or more leaflets 162. For example, as shown in the example embodiment, the one or more leaflets 162 may be attached to the liner 164 along an arcuate or fixed edge of the leaflet 162. The liner 164 may extend from the arcuate or fixed edge of the leaflet 162 and extend upward toward the upper end of the inner frame 120.

[0135] Valve body 160 may share features such as structural and / or functional features that are identical or at least similar to those of other valve bodies described herein (e.g., but not limited to valve bodies 260, 660, 760, 870, 970, 1560, 1660, 1960, 2060, 2260, 2360, 2460 discussed below). Furthermore, although valve body 160 has been described as comprising a plurality of leaflets 162 and a liner 164, it should be understood that valve body 160 need not include all features. For example, in some embodiments, valve body 160 may include a plurality of valve leaflets 162 while omitting the liner 164. It should be understood that other types of valves may be used in conjunction with or in place of valve body 160. For example, the valve may be a mechanical valve, such as a bulbous or cage-like valve.

[0136] Next, continue to refer to... Figure 1The skirt 180 shown may be attached to the inner frame 120 and / or the outer frame 140. As shown, the skirt 180 may be positioned around and secured to a portion of the exterior of the inner frame 120 and / or the outer frame 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. Although not shown, it should be understood that the skirt 180 may be positioned around and secured to a portion of the interior of the inner frame 120 and / or the outer frame 140. Moreover, it should be understood that while the skirt 180 may follow the contours of portions of the inner frame 120 and the outer frame 140, at least a portion of the skirt 180 may be spaced apart from at least a portion of 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 portion of the skirt 180 may be loose, allowing the skirt 180 to move relative to the upper region 146, or it may be taut to generally hold the skirt 180 in place.

[0137] The skirt 180 may be annular and may extend circumferentially and completely around the inner frame 120 and / or outer frame 140. The skirt 180 may prevent or inhibit backflow of fluids (such as blood) around the prosthesis 100. For example, when the skirt 180 is positioned annularly around the outer surface of the inner frame 120 and / or outer frame 140, the skirt 180 may form an axial barrier against fluid flow outside the inner frame 120 and / or outer frame 140 (when deployed within a body cavity such as a natural valve annulus). The skirt 180 may promote inward tissue growth 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 provide further fixation of the prosthesis 100 to the body cavity. In some embodiments, the skirt 180 may be tautly attached to the inner frame 120 and / or outer frame 140 such that the skirt 180 is generally immobile relative to the inner frame 120 and / or 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.

[0138] Skirt 180 may share features such as structure and / or function that are the same as or at least similar to those of other skirts described herein (such as, but not limited to, skirts 280, 780, 890, 990, 1580, 1590, 1680, 1690, 1980, 1990, 2080, 2280, 2380, 2480, 2490 discussed below).

[0139] Although the prosthesis 100 has been described as including an inner frame 120, an outer frame 140, a valve body 160, and a skirt 180, it should be understood that the prosthesis 100 need not include all components. For example, in some embodiments, the prosthesis 100 may include the inner frame 120, the outer frame 140, and the valve body 160, while omitting the skirt 180. Furthermore, although the components of the prosthesis 100 have been described and exemplified as separate components, it should be understood that one or more components of the prosthesis 100 may be formed integrally or monolithically. For example, in some embodiments, the inner frame 120 and the outer frame 140 may be formed integrally or monolithically as a single component.

[0140] Next reference Figure 2-6 This illustrates an embodiment of a prosthesis 200 or a component of the prosthesis 200 in an expanded configuration. The prosthesis 200 may include an inner frame 220, an outer frame 240, a valve body 260, and a skirt 280. The longitudinal axis of the prosthesis 200 may be defined as a central axis extending through the center of the prosthesis 200 between its upper and lower ends. In some cases, the prosthesis 200 may be oriented such that its upper end is the proximal portion and its lower end is the distal portion.

[0141] First refer to Figure 2-5 The outer frame 240 shown may include an outer frame body 242 and an outer frame anchoring structure 244. The outer frame 240 may share features such as structural and / or functional features, which, in conjunction with the above, Figure 1 The outer frame 140 described has the same or at least similar features.

[0142] The outer frame body 242 may have an upper region 246, a middle region 248, and a lower region 250. As shown, when in an expanded configuration such as a fully expanded configuration, the outer frame body 242 may have an enlarged shape, wherein the middle region 248 and the lower region 250 are larger than the upper region 246. The enlarged shape of the outer frame body 242 may advantageously allow the outer frame body 242 to engage with natural valve annulus, natural valve leaflet, or other body cavity, while separating the inlet and outlet from the heart or blood vessel walls. This can help reduce undesirable contact between the prosthesis 200 and the heart or blood vessels (such as the atrioventricular walls of the heart).

[0143] The upper region 246 of the outer frame body 242 may include a generally longitudinally extending portion 246a and an outwardly extending portion 246b. The longitudinally extending portion 246a may be generally concentric with the inner frame 220. The outwardly extending portion 246b may extend radially outward away from the longitudinal axis of the prosthesis 200. In some embodiments, the outwardly extending portion 246b may extend in a direction more perpendicular to the longitudinal axis 202 than parallel and / or may extend downward from the longitudinally extending portion 246a. However, it should be understood that the outwardly extending portion 246b may be generally perpendicular to the longitudinal axis and / or extend upward from the longitudinally extending portion 246a. Moreover, it should be understood that the longitudinally extending portion 246a may be omitted.

[0144] In some embodiments, the outwardly extending portion 246b may form an angle between about 20 degrees and about 70 degrees with a plane perpendicular to the longitudinal axis of the prosthesis 200, an angle between about 30 degrees and about 60 degrees with a plane perpendicular to the longitudinal axis of the prosthesis 200, an angle between about 40 degrees and about 50 degrees with a plane perpendicular to the longitudinal axis of the prosthesis 200, an angle between about 45 degrees with a plane perpendicular to the longitudinal axis of the prosthesis 200, any subrange within these ranges, or any other desired angle. In some embodiments, the outwardly extending portion 246b may form an angle less than 70 degrees with a plane perpendicular to the longitudinal axis of the prosthesis 200, an angle less than 55 degrees with a plane perpendicular to the longitudinal axis of the prosthesis 200, an angle less than 40 degrees with a plane perpendicular to the longitudinal axis of the prosthesis 200, an angle less than 25 degrees with a plane perpendicular to the longitudinal axis of the prosthesis 200, or less than any other desired angle.

[0145] The middle region 248 of the outer frame body 242 may extend generally downward from the outwardly extending portion 246b of the upper region 246. As shown, the middle region 248 may have a generally constant diameter from the upper end to the lower end of the middle region 248, such that the middle region 248 forms a generally cylindrical shape. However, it should be understood that the diameters of the upper end, the lower end, and / or the portion in between may be different. For example, in some embodiments, the diameter of the portion between the upper and lower ends may be larger than the diameters of the upper and lower ends, such that the middle region 248 has a generally bulbous shape (as shown, for example, combined with...). Figure 7-8 Example frame 300. 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.

[0146] The overall uniformity of the diameter of the intermediate region 248 from top to bottom, together with the axial dimension between the top and bottom ends (i.e., the "height" of the intermediate region 248), provides a significantly large circumferential area on which the natural valve annulus or other body cavity can engage. This can advantageously improve the fixation of the outer frame 240 to the natural valve annulus or other body cavity. This can also improve the seal between the outer frame 240 and the natural valve annulus or other body cavity, thereby reducing paravalvular leakage.

[0147] At the junction between the upper region 246 and the middle region 248, the outer frame body 242 may include a bend 252. The bend 252 may be a bend about a circumferential axis, such that the middle region 248 extends in a direction more parallel to the longitudinal axis of the prosthesis 200 than the outwardly extending portion 246b of the upper region 246. In some embodiments, the bend 252 may generally form an arc having an angle between about 20 degrees and about 90 degrees. For example, as shown in the example embodiment, the arc may have an angle of about 45 degrees. In some embodiments, the bend 252 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 such that the bend 252 forms a circular arc, or it may vary along the length of the bend 252.

[0148] The lower region 250 of the outer frame body 242 can generally extend downward from the lower end of the intermediate region 248. As shown, the lower region 250 of the outer frame body 242 can have a generally constant diameter from the upper end to the lower end of the lower region 250, such that the lower region 250 forms a generally cylindrical shape. However, it should be understood that the diameters of the upper end, the lower end, and / or portions therein can be different. For example, in some embodiments, the diameter of the upper end of the lower region 250 can be larger than the diameter of the lower end of the lower region 250, such that the lower region 250 extends radially inward toward the longitudinal axis of the prosthesis 200. In some embodiments, the diameter of the lower end can be larger than the diameter of the upper end.

[0149] As shown, the diameters of the intermediate region 248 and the lower region 250 are generally equal, such that the intermediate region 248 and the lower region 250 together form an overall cylindrical shape. However, it should be understood that the diameters of the intermediate region 248 and the lower region 250 may be different. For example, the diameter of the lower region 250 may be smaller than the diameter of the intermediate region 248. Furthermore, although the outer frame body 242 has been described and exemplified as cylindrical or having a circular cross-section, it should be understood that all or part of the outer frame body 242 may have a non-circular cross-section, such as, but not limited to, D-shaped, elliptical, or other oval cross-sectional shapes.

[0150] The outer frame body 242 in the expanded configuration may have a diameter at its widest portion between approximately 30 mm and approximately 60 mm, approximately 35 mm and approximately 55 mm, approximately 40 mm, any subrange within these ranges, or any other desired diameter. The outer frame body 242 in the expanded configuration may have a diameter at its narrowest portion between approximately 20 mm and approximately 40 mm, any subrange within these ranges, or any other desired diameter. In some embodiments, in the expanded configuration, the ratio of the diameter at the widest portion of the outer frame body 242 to the diameter at the narrowest portion of the frame body 242 may be approximately 3:1, approximately 5:2, approximately 2:1, approximately 3:2, approximately 4:3, any ratio within these ratios, or any other desired ratio.

[0151] The outer frame body 242 may have a configuration that is axially compact relative to its radial dimension. In an expanded configuration, the outer frame body 242 may have an axial dimension (i.e., the “height” of the outer frame body 242) between its upper and lower ends: 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 desired height. In some embodiments, when the frame is in its expanded configuration, the ratio of the diameter of the largest portion of the outer frame body 242 to the height of the outer frame body 242 may 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. Therefore, in some embodiments, the width at the largest portion of the outer frame body 242 may be greater than the height of the outer frame body 242.

[0152] Continue to refer to Figure 2-5 The outer frame 240 shown, and the outer frame body 242, may include a plurality of pillars, wherein at least some of the pillars form units 254a-c. Any number of pillar configurations can be used, such as the rings showing undulating pillars forming elliptical, oval, rounded polygonal, teardrop, V-shaped, rhomboid, curved, and various other shapes. For reference, Figure 2 The pillars have been highlighted to show their overall configuration; however, it should be understood that one or more pillars may not actually be visible. For example, skirt 280 may be formed of opaque material and positioned on the exterior of outer frame body 242.

[0153] The ascending unit 254a may have an irregular octagonal shape, such as a heart shape. Unit 254a can be formed by a combination of struts. As shown in the example embodiment, the upper portion of unit 254a may be formed by a set of circumferentially expandable struts 256a, which have a Z-shaped or undulating shape forming repeating "V" shapes. The circumferentially expandable struts 256a may be radially inclined or bent outward away from the longitudinal axis of the prosthesis 200, such that the upper portion of the struts 256a is positioned closer to the longitudinal axis of the prosthesis 200 than the lower portion of the struts 256a. The middle portion of unit 254a may be formed by a set of struts 256b, which extend downward from the bottom end of each "V". The struts 256b may extend along a plane parallel to and / or extending through the longitudinal axis of the prosthesis 200. The portion of unit 254a extending upward from the bottom end of the struts 256b can be considered a substantially non-shortened portion of the outer frame 240. The following section will discuss in more detail the concept of shortening, which refers to the ability of a frame to shorten longitudinally when it expands radially.

[0154] The lower portion of unit 254a may be formed by a set of circumferentially expandable struts 256c, each strut having a Z-shaped or undulating shape forming a repeating "V". The lower tip or lower end of the circumferentially expandable strut 256c may be located at or near the junction of the upper region 246 and the middle region 248. In some embodiments, one or more of the upper tips or upper ends of the circumferentially expandable struts 256c may be "free" vertices not connected to the struts. As shown in the example embodiment, every other upper tip or upper end of the circumferentially expandable strut 256c is a free vertice. However, it should be understood that other configurations may be used. For example, each upper vertex along the upper end may be connected to a strut.

[0155] As shown in the example embodiment, the middle and / or lower rows of units 254b-c may have a different shape than the first row of units 254a. The middle row of units 254b may have a rhomboid or generally rhomboid shape. Units 254b-c can be considered as substantially shortened portions of the outer frame 240. The rhomboid or generally rhomboid shape can be formed by a combination of struts. The upper portion of unit 254b may be formed by the set of circumferentially expandable struts 256c, such that unit 254b shares struts with unit 254a. The lower portion of unit 254b may be formed by a set of circumferentially expandable struts 256d. As shown in the example embodiment, one or more circumferentially expandable struts 256d may generally extend in a downward direction. The one or more circumferentially expandable struts 256d may include bends 252 such that the upper portion of the strut 256d can be positioned closer to the longitudinal axis of the prosthesis 200 than the lower portion of the strut 256d relative to the longitudinal axis of the prosthesis 200. In some embodiments, one or more circumferentially expandable struts 256d may extend radially outward away from the longitudinal axis of the prosthesis 200. As will be discussed in further detail below, these radially outward portions of the struts 256d may form part of the outer frame anchoring structure 244.

[0156] The descending unit 254c may have an irregular octagonal shape. The upper portion of unit 254c may be formed by the set of circumferentially expandable struts 256d, such that unit 254c shares struts with unit 254b. The lower portion of unit 254c may be formed by a set of circumferentially expandable struts 256e. The circumferentially expandable struts 256e may generally extend in a downward direction. In some embodiments, the circumferentially expandable struts 256e may extend radially inward toward the longitudinal axis of the prosthesis 200 (as shown, for example, in combination with...). Figure 7-8 (See frame 300 shown). The circumferentially expandable strut 256e can tilt or bend toward the longitudinal axis of the prosthesis 200.

[0157] Although supports 256a-e are generally described and exemplified as straight line segments, it should be understood that some or all of supports 256a-e may not form perfectly straight line segments. For example, supports 256a-e may include a certain curvature such that the upper vertex and / or the lower vertex are curved.

[0158] As shown in the example embodiments, there can be rows of twelve units 254a, rows of twenty-four units 254b, and rows of twelve units 254c. Although each unit 254a-c is shown to have the same shape as the other units 254a-c in the same row, it should be understood that the shapes of units 254a-c within a row can be different. Moreover, it should be understood that any number of rows of units can be used, and any number of units can be contained in a row. In some embodiments, the number of units can correspond to the number of anchors or anchor tips forming the outer frame anchoring structure 244. As shown, the number of units in the upper row of units 254a and the lower row of units 254c can have a 1:1 correspondence with the number of anchors in the outer frame anchoring structure 244 (i.e., 12 units in each row of units 254a, 254c, and the anchoring structure 244 has 12 anchors). The number of units in row 254b can have a 2:1 correspondence with the number of anchors in the outer frame anchoring structure 244 (i.e., 24 units in row 254b and 12 anchors in anchoring structure 244). It should be understood that other ratios of the number of units per row to the number of anchors in each anchoring structure can be used, such as, but not limited to, 3:1, 4:1, 5:1, 6:1, and other desired ratios. In some embodiments, all three rows of units 254a-c may have the same number of units. Furthermore, it should be understood that fewer or more rows of units can be used.

[0159] The geometry of units 254a-c allows for shortening of units 254a-c when the outer frame 240 expands. Thus, one or more of units 254a-c can allow for shortening of the outer frame 240 when it expands. Shortening of the outer frame 240 can be used to fix the prosthesis to intracavitary tissue within the body cavity, such as tissue at or near the natural valve, including but not limited to the natural valve annulus and / or leaflet. For example, expansion of the outer frame 240 can allow it to apply radially outward forces to tissue at or near the natural valve, such as the natural valve annulus and / or leaflet.

[0160] Continue to refer to Figure 2-5The outer frame 240 shown has an outer frame anchoring structure 244 that extends outward relative to the longitudinal axis of the prosthesis 200. The outer frame anchoring structure 244 may extend at or near the junction between the upper region 246 and the middle region 248 of the outer frame body 242. As shown, the outer frame anchoring structure 244 may be formed by one or more anchors extending from the frame body 242 radially outward from the longitudinal axis of the outer frame 240 and / or generally toward the lower end of the outer frame 240. The anchors of the outer frame anchoring structure 244 may be attached to the outer frame body 242 at one or more attachment points. For example, the anchors of the outer frame anchoring structure 244 may be formed by two of the circumferentially expandable struts 256d, which are radially outwardly oriented and joined together at an end or tip 244a. Individual anchors may form an overall “V” shape.

[0161] In some embodiments, the outer frame anchoring structure 244 may extend in a direction more perpendicular to the longitudinal axis of the prosthesis 200 than parallel. As shown, the outer frame anchoring structure 244 may extend in a downward direction generally parallel to the outward extension 246b. In some embodiments, the outer frame anchoring structure 144 may extend generally perpendicular to the longitudinal axis 102 and / or in an upward direction.

[0162] In some embodiments, the descending unit 254c may be omitted. For example, the struts 256e may extend downward along a plane parallel to the longitudinal axis. These struts may extend between the anchors of the inner frame anchoring structure 224. This may advantageously allow the outer frame 240 to extend further downward, and may advantageously allow the skirt (such as skirt 280) to extend further downward and increase the effective sealing area. For example, when the outer frame 240 remains in a corrugated configuration and the inner frame anchoring structure 224 is released, the struts will not intersect with the individual anchors of the inner frame anchoring structure 224, regardless of the length of the struts. This may allow the individual anchors of the inner frame anchoring structure 224 to transition from a corrugated configuration to an expanded configuration without contacting the outer frame 240 while the outer frame 240 remains in a corrugated configuration.

[0163] Next reference Figure 6An example is shown of the inner frame 220 and valve body 260 of the prosthesis 200. The inner frame 220 may include an inner frame body 222 and an inner frame anchoring structure 224. As shown, the inner frame body 222 may have an upper region 226, a middle region 228, and a lower region 230. As shown, the inner frame body 222 may have a generally cylindrical shape such that the diameters of the upper region 226, the middle region 228, and the lower region 230 are generally equal. However, it should be understood that the diameters of the upper region 226, the middle region 228, and / or the lower region 230 may be different. For example, in some embodiments, the diameter of the middle region 228 may be larger than that of the upper region 226 and the lower region 230, such that the inner frame body 222 has a generally bulbous shape. In some embodiments, the diameter of the lower region 230 may be larger than that of the upper region 226. In other embodiments, the diameter of the upper region 226 may be larger than that of the lower region 230.

[0164] The diameters of the upper region 226, the middle region 228, and / or the lower region 230 of the inner frame body 222 can be selected such that the inner frame body 222 is sufficiently separated from the body cavity when the prosthesis 200 is positioned within the body cavity. For example, in an embodiment where the prosthesis 200 is positioned within the natural mitral valve, the diameter of the inner frame body 222 can be smaller than the diameter of the natural mitral valve annulus. If the diameter of the natural mitral valve annulus is approximately 40 mm, the diameter of the inner frame body 222 can be approximately 30 mm. Therefore, the diameter of the inner frame body 222 can be approximately 75% of the diameter of the natural mitral valve annulus.

[0165] In some embodiments, the diameter of the inner frame body 222 may be between about 40% and about 90% of the diameter of the natural valve annulus, between about 60% and about 85% of the diameter of the natural valve annulus, between about 70% and about 80% of the diameter of the natural valve annulus, any other subrange between these ranges, or any other desired percentage. In some embodiments, the diameter of the inner frame body 222 may be in the range of about 20 mm to about 40 mm when expanded, between about 25 mm and about 35 mm when expanded, between about 28 mm and about 32 mm when expanded, any other subrange between these ranges when expanded, or any other desired diameter when expanded. Although the inner frame body 222 has been described and exemplified as cylindrical or having a circular cross-section, it should be understood that all or part of the inner frame body 222 may have a non-circular cross-section, such as, but not limited to, D-shaped, elliptical, or other oval cross-sectional shapes.

[0166] In other embodiments, the diameter of portions of the inner frame body 222, such as the upper region 226, the middle region 228, and / or the lower region 230, can be selected such that the inner frame body 222 is positioned at the periphery of the body cavity. For example, in an embodiment where the prosthesis 200 is positioned within the natural mitral valve, the diameter of the inner frame body 222 may be approximately equal to the diameter of the natural mitral valve annulus.

[0167] Continue to refer to Figure 6 The inner frame 220 shown, the inner frame body 222 may include a plurality of pillars, wherein at least some of the pillars form units 234a-b. Any number of pillar configurations may be adopted, such as the rings showing undulating pillars forming elliptical, oval, rounded polygonal and teardrop shapes, as well as V-shaped, rhomboid, curved and various other shapes.

[0168] The ascending unit 234a and descending unit 234b may have a rhomboid or generally rhomboid shape. The rows of units 234a-b may be formed by a combination of struts. As shown in the example embodiment, the ascending unit 234a may be formed by a first set of circumferentially expandable struts 236a and a second set of circumferentially expandable struts 236b. The descending unit 236b may be formed by the second set of circumferentially expandable struts 236b and a third set of circumferentially expandable struts 236c. The first, second, and third sets of struts 236a-c may have a zigzag or undulating shape forming a repeating “V” shape. Although struts 236a-c are generally described and exemplified as straight segments, it should be understood that some or all of the struts 236a-c may not form completely straight segments. For example, struts 236a-c may include a certain curvature such that the upper apex and / or lower apex are curved.

[0169] As shown in the example embodiment, the upper row unit 234a and the lower row unit 234b extend in a direction generally parallel to the longitudinal axis of the prosthesis 200. There can be one row of 12 units 234a and one row of 12 units 234b. While each of units 234a-b is exemplified as having the same shape as the other units 234a-b in the same row, it should be understood that the shapes of units 234a-b within a row can be different. Furthermore, it should be understood that any number of rows of units can be used, and any number of units can be contained within a row. In some embodiments, the number of units may correspond to the number of anchors or anchor tip forming the inner frame anchoring structure 224. As shown, the number of units in the upper row unit 234a and the lower row unit 234b may have a 1:1 correspondence with the number of anchors in the outer frame anchoring structure 224 (i.e., 12 units in each row of units 234a-b, and 12 anchors in the anchoring structure 224). It should be understood that other ratios of the number of units per row to the number of anchors per anchoring structure may be used, such as, but not limited to, 3:1, 4:1, 5:1, 6:1, and other desired ratios. In some embodiments, the two rows of units 234a-b may have different numbers of units. Moreover, it should be understood that fewer or more rows of units may be used.

[0170] The geometry of units 234a-b allows for shortening of units 234a-b when the inner frame 220 expands. Thus, one or more of units 234a-b can allow for shortening of the inner frame 220 when it expands. As will be discussed in further detail, shortening of the inner frame 220 can be used to fix the prosthesis to intracavitary tissue within the body cavity, such as tissue at or near the natural valve, including but not limited to the natural valve annulus and / or leaflet. For example, expansion of the inner frame 220 can allow the inner frame anchoring structure 224 to extend radially outward and closer to tissue within the body cavity, such as the natural valve annulus and / or leaflet, to engage with tissue within the body cavity.

[0171] Continue to refer to Figure 6 The inner frame 220 shown may have an inner frame anchoring structure 224 having an end or tip 224a positioned radially outward relative to the longitudinal axis of the prosthesis 200. The inner frame anchoring structure 224 may extend at or near the lower end of the lower region 230 of the inner frame body 222. As shown, the inner frame anchoring structure 224 may be formed by a plurality of individual anchors extending from the frame body 222. Anchors may extend downward from one or more attachment points to the frame body 222, including but not limited to the lower apex of unit 234b. Anchors may be bent to extend radially outward generally along the longitudinal axis of the prosthesis 200. As shown in the example embodiment, anchors may extend upward toward the end or tip 224a.

[0172] As shown in the example embodiments, the tip or end 224a extends upward in a direction generally parallel to the longitudinal axis of the prosthesis 200. In some embodiments, the tip or end 224a of the anchoring structure 224 may extend generally perpendicular to the longitudinal axis of the prosthesis 200. This can advantageously increase the tissue contact area of ​​the tip 224a of the anchor. This increased tissue contact area can advantageously reduce the stress exerted on the tissue by the tip 224a, thereby reducing the amount of pressure and the possibility of tissue trauma. In some embodiments, the tip or end 224a of the anchoring structure 224 extends radially inward toward the longitudinal axis and / or radially outward away from the longitudinal axis.

[0173] The distal ends or tips 224a, 244a described above can advantageously provide a non-traumatic surface that can be used to contact or engage endoluminal tissue without causing unnecessary or undesirable trauma to the tissue. For example, the distal ends or tips 224a, 244a can form flat, substantially flat, curved, or other non-sharp surfaces to allow the distal ends to engage and / or grasp tissue without piercing or penetrating it. Ring-shaped tips or ring-shaped anchors can help prevent the frame from being intercepted on or near the treatment location. For example, each ring can be configured such that when the prosthesis 200 is deployed in situ and the anchoring structures 224, 244 expand away from the frame bodies 222, 242, the movement of each ring from the delivery location to the deployment location avoids interception on the papillary muscles. As shown in the example embodiment, the inner frame anchoring structure 224 may include a lacrosse-head-shaped distal end or tip 224a. The outer frame anchoring structure 244 may include a tip or end 244a having a “U” or rounded shape.

[0174] As shown in the example implementation, anchoring structures 224, 244 may include twelve individual anchors; however, it should be understood that more or fewer individual anchors may be used. For example, the number of individual anchors may be chosen to be a multiple of the number of assemblies in the valve body 260. Thus, for a prosthesis 200 with three assemblies in the valve body 260, the inner frame anchoring structure 224 and / or the outer frame anchoring structure 244 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. It should be understood that the number of individual anchors need not correspond to the number of assemblies in the valve body 260. Furthermore, although the prosthesis 200 includes anchoring structures 224, 244 each with twelve anchors, it should be understood that more or fewer anchors may be used. In some embodiments, instead of a 1:1 correspondence (i.e., twelve anchors each) between the number of anchors in the inner frame anchoring structure 224 and the outer frame anchoring structure 244, other ratios can be used. For example, a 1:2 or 1:3 correspondence between anchors is possible, such that the inner frame anchoring structure 224 or the outer frame anchoring structure 244 has fewer anchors than the other anchoring structure.

[0175] Continue to refer to Figure 6 The inner frame 220 shown may include covers and / or cushions 238 to surround or partially surround at least a portion of the inner frame anchoring structure 224, such as a tip or end 224a. The covers and / or cushions 238 may be similar to those described in U.S. Publication No. 2015 / 0328000, the entire contents of which are incorporated herein by reference. The covers and / or cushions 238 may fit snugly around the tip 224a of the inner frame anchoring structure 224, or may have additional padding such that the covers extend radially away from the inner frame body 222. As shown in the example embodiment, the covers and / or cushions 238 are attached to an anchoring subgroup of the inner frame anchoring structure 224 such that the covers and / or cushions 238 are used on every third anchor. In some embodiments, the outer frame anchoring structure 244 may include a cover and / or padding to surround or partially surround at least a portion of the outer frame anchoring structure 244, such as the tip or end 244a.

[0176] It should be understood that a greater or lesser number of covers and / or pads 238 may be used on the anchors of the inner frame anchoring structure 224 and / or the outer frame anchoring structure 244. For example, covers and / or pads 238 may be used on every other anchor, such that the ratio of covers and / or pads 238 to anchors is 1:2. As another example, covers and / or pads 238 may be used on each anchor (e.g., Figure 2-5 (As shown). In some embodiments, all anchors may have covers and / or padding, with some anchors having less cushioning than others. In some embodiments, all anchors may have padded covers. In other embodiments, all anchors may have snug-fitting padding. In other embodiments, the configuration of covers and / or padding may differ between the inner frame anchoring structure 224 and the outer frame anchoring structure 244.

[0177] The covering and / or padding 238 may be formed of a deformable material. When the top of the covering and / or padding 238 is subjected to pressure due to a downward force, the covering and / or padding 238 may compress and expand laterally outward. This force may be applied to the covering and / or padding 238, for example, when the covering and / or padding 238 contacts the ventricular side of the mitral valve annulus during systole. The compression and lateral expansion of the covering and / or padding 238 may increase the surface area of ​​the covering and / or padding 238 in contact with tissue, thereby applying less pressure to the tissue and reducing the likelihood of trauma.

[0178] Continue to refer to Figure 2-6 The anchoring structures 224 and 244 shown herein have their ends 224a of the inner frame anchoring structure 224 generally circumferentially aligned with the ends 244a of the outer frame anchoring structure 244, meaning that the ends 224a of the inner frame anchoring structure 224 are aligned with the ends 244a of the outer frame anchoring structure 244 in the circumferential direction. In other embodiments (not shown), the ends 224a of the inner frame anchoring structure 224 and the ends 244a of the outer frame anchoring structure 244 may be offset or staggered circumferentially, meaning that the ends 224a of the inner frame anchoring structure 224 are not aligned with the ends 244a of the outer frame anchoring structure 244 in the circumferential direction.

[0179] Preferably, each anchoring structure 224, 244 is generally positioned or extends radially outward from the stylosity 200, such that the anchor tips or ends 224a, 244a are generally spaced apart or radially outward from the rest of the frame bodies 222, 242, and from one or more attachment points or bases of the anchors of the anchoring structures 224, 244. For example, the anchor tips 224a, 244a may be located radially outside the middle region 248 and / or lower region 250 of the outer frame body 242, and the tips 224a, 244a are axially spaced apart from each other.

[0180] As shown in the example embodiment, at least some anchoring structures, such as anchoring structure 244, can extend from the outer surface of the middle region 248 and / or lower region 250 of the outer frame body 242 to a radial distance that is about 110% or more of the expansion diameter of the middle region 248 of the outer frame body 242 at the plane of the tip 244a. At least some anchoring structures, such as anchoring structure 224, can extend from the outer surface of the middle region 248 of the outer frame body 242 to a radial distance that is slightly greater than the expansion diameter of the middle region 248 and / or lower region 250 of the outer frame body 242 at the plane of the tip 224a. As shown, the tip 224a can be positioned such that the tip 224a contacts the exterior of the outer frame body 242. This can advantageously clamp or grasp body cavity tissue therebetween, as will be discussed in further detail below. For example, in the case of prosthesis 200 used for a natural mitral valve, the natural leaflet and / or part of the natural mitral valve annulus can be clamped or held between the anchoring structure 224 and the middle region 248 and / or the lower region 250 of the outer frame body 242.

[0181] In some embodiments, all anchors of the inner frame anchoring structure 224 and / or all anchors of the outer frame anchoring structure 244 extend at least to the radial distance. In other embodiments, less than all anchors of the inner frame anchoring structure 224 and / or less than all anchors of the outer frame anchoring structure 244 extend to the radial distance. The outermost diameter of the inner frame anchoring structure 224 and / or the outer frame anchoring structure 244 may be larger than the diameter of the frame bodies 222, 224 as described above, and may be in the range of about 35 mm to about 70 mm, about 35 mm to about 60 mm, about 40 mm to about 60 mm, about 45 mm to about 50 mm, any subrange within these ranges, or any other desired diameter when expanded.

[0182] As shown, the inner frame anchoring structure 224 can be positioned less radially outward than the outer frame anchoring structure 244. However, it should be understood that in other embodiments, the inner frame anchoring structure 224 and the outer frame anchoring structure 244 may extend radially outward from the longitudinal axis of the prosthesis 200 to approximately the same radial dimension, or the outer frame anchoring structure 244 may be positioned less radially outward than the inner frame anchoring structure 224. This configuration can be advantageous when positioning and securing the prosthesis in a natural annulus or other body location.

[0183] In some embodiments, individual anchors may extend radially outward from the frame at the base of the anchor and terminate at the tip of the anchor. Individual anchors may be attached to the frame at one of a variety of different locations, including apexes, joints, other portions of the support, etc. Furthermore, the anchors forming anchor structures 224, 244 may include first, second, third, or more spaced-apart bending phases along the length of each anchor. Further details that may be combined with and / or interchanged with the features described herein are disclosed in U.S. Publications 2014 / 0277422, 2014 / 0277427, 2014 / 0277390, and 2015 / 0328000, and U.S. Application No. 15 / 653,390, filed July 18, 2017, entitled “REPLACEMENT HEART VALVE PROSTHESIS,” which are incorporated herein by reference.

[0184] During one or more phases of the cardiac cycle, such as systole and / or diastole, one or both of the anchoring structures 224, 244 may contact or engage the natural valve annulus, such as the natural mitral valve annulus, tissue extending beyond the natural valve annulus, natural leaflets, and / or other tissue at or around the implantation site. In some embodiments, during one or more phases of the cardiac cycle, such as systole and / or diastole, one or both of the anchoring structures 224, 244 may not contact or engage, or may only partially contact or engage the natural valve annulus, such as the natural mitral valve annulus, tissue extending beyond the natural valve annulus, natural leaflets, and / or other tissue at or around the implantation site. However, it should be understood that in some embodiments, when the prosthesis 200 is used to replace a mitral valve prosthesis, both the inner frame anchoring structure 224 and the outer frame anchoring structure 244 may be sized to contact or engage the natural mitral valve annulus during diastole and / or systole.

[0185] Anchoring structures 224, 244 and anchoring tips 224a, 244a are preferably positioned along the prosthesis 200, with at least a portion of the shortened portion positioned between anchoring structures 224, 244 such that portions of anchoring structures 224, 244 will move closer together as the prosthesis 200 expands. This allows anchoring structures 224, 244 on opposite sides of the natural mitral annulus to approach each other, thereby securing the prosthesis at the mitral valve. In some embodiments, anchoring structures 224, 244 may be positioned such that anchoring structures 224, 244 do not simultaneously contact opposite portions of the natural mitral annulus. For example, when the prosthesis 200 is used to replace a mitral valve prosthesis, in some embodiments, during at least the systolic phase, the inner frame anchoring structure 224 is sized to contact or engage the natural mitral annulus, while the outer frame anchoring structure 244 is sized to be spaced apart from the natural mitral annulus. This can be beneficial when the outer frame anchoring structure 244 is used to provide stability and assist in alignment of the prosthesis. In some embodiments, the anchoring structures 224, 244 can be positioned such that they grip the opposite side of the natural mitral valve annulus.

[0186] Although anchoring structures 224, 244 have been exemplified as extending from the lower end of the lower region 230 of the inner frame body 222 and at the junction between the upper region 246 and the middle region 248 of the outer frame body 242, it should be understood that anchoring structures 224, 244 may be positioned along any other part of the prosthesis 200 as needed. Furthermore, although two anchoring structures 224, 244 are included in the illustrated embodiment, it should be understood that more or fewer sets of anchoring structures may be used.

[0187] Return to reference Figure 6 The inner frame 220 shown may include a set of locking connectors 232 extending at or near the upper end of the upper region 226 of the inner frame body 222, such as the upper apex of unit 234a. As shown, the inner frame 220 may include twelve locking connectors 232; however, it should be understood that more or fewer locking connectors may be used. The locking connectors 232 may extend generally upward from the upper region 226 of the inner frame body 222 in a direction generally aligned with the longitudinal axis of the prosthesis 200. As shown in the example embodiment, the locking connector 232 may include a longitudinally extending strut 232a. At the upper end of the strut 232a, the locking connector 232 may include an enlarged head 232b. As shown, the enlarged head 232b may have a semi-circular or semi-elliptical shape, forming a “mushroom” shape with the strut 232a. The locking connector 232 may include an eyelet 232c that can be positioned through the enlarged head 232b. It should be understood that the locking connector 232 may include eyelets located in other locations, or may include more than one eyelet.

[0188] The locking connector 232 can be advantageously used with a variety of delivery systems. For example, the shape of the strut 232a and the enlarged head 232b can be used to secure the inner frame 220 to a slot-based delivery system. The eyelet 232c can be used to secure the inner frame 220 to a tether-based delivery system, such as those that utilize stitches, threads, or fingers to control the delivery of the inner frame 220 and the prosthesis 200. This can advantageously facilitate in-situ re-capture and repositioning of the inner frame 220 and the prosthesis 200. In some embodiments, the prosthesis 220 can be used with the delivery systems described herein, including but not limited to those described in U.S. Patent Nos. 8,414,644 and 8,652,203 and U.S. Publication No. 2015 / 0238315, the entire contents of which are hereby incorporated by reference and are a part of this specification.

[0189] Although the locking connector 232 has been described as being attached to the inner frame body 222, it should be understood that the locking connector 232 may be attached to other parts of the prosthesis 200, such as, but not limited to, the outer frame body 242. For example, in some embodiments, the locking connector 232 may extend from the upper end of the upper region 246 of the outer frame body 242. Moreover, it should be understood that some or all of the locking connector 232 may be omitted. For example, in some embodiments, the strut 232a may be omitted, such that the enlarged head 232b and eyelet 232c are positioned at the upper end of the upper region 226 of the inner frame body 222, such as at the upper apex of unit 234a.

[0190] Next reference Figure 6 The valve body 260 shown is positionable within an inner frame 220. The valve body 260 can be a replacement heart valve comprising a plurality of valve leaflets 262. Each valve leaflet 262 may include a first edge 264, a second edge 266, and a connector 268 (e.g., ...). Figure 5 (As shown), a connector 268 is used to attach the valve leaflets 262 together at the junction of the valve body 260. A connector 268 can be used to secure the valve leaflets 262 to the inner frame 220. A first edge 264 may be an arcuate edge and can be generally fixed in place relative to the frame 220. A second edge 266 may be a freely movable edge that allows the valve body 260 to open and close.

[0191] Multiple valve leaflets 262 can function in a manner similar to a natural mitral valve, or, if necessary, in a manner similar to any other valve in a vascular system. The multiple valve leaflets 262 can open in a first position and then engage with each other in a second position to close the valve. The multiple valve leaflets 262 can be used as unidirectional valves, such that flow in one direction causes the valve to open and flow in a second direction opposite to the first direction causes the valve to close. For example, as shown in the example embodiment, the valve body 260 can open to allow blood to flow through the valve body 260 in a direction from top to bottom. The valve body 260 can close to inhibit blood flow through the valve body 260 in a direction from bottom to top. When the prosthesis 200 is oriented such that the upper end is proximal and the lower end is distal, the valve body 260 can be positioned such that the valve body 260 can open to allow blood to flow through the valve body 260 in a proximal to distal direction and close to inhibit blood flow in a distal to proximal direction. The valve body 260 can be configured to open naturally with the heartbeat. For example, the valve body 260 can open during diastole and close during systole. The valve body 260 can replace damaged or diseased natural heart valves, such as a diseased natural mitral valve.

[0192] The valve body 260 may include a liner 270. The liner 270 may be used to assist fluid flow through and / or around the prosthesis 200, such as through and around the inner frame 220 and leaflets 262. The liner 270 may surround at least a portion of the leaflets 262 and be attached to one or more of the leaflets 262. For example, as shown in the example embodiment, the one or more leaflets 262 may be attached to the liner 270 along a first edge 264 of the leaflet 262.

[0193] As shown in the example embodiment, the liner 270 can be positioned within the inner frame 220 and can form the inner wall of the prosthesis 200. For example, the liner 270 can be positioned such that the liner 270 is radially inward from the struts 236a-c of the inner frame 220 relative to the longitudinal axis of the prosthesis 200. In this way, the fluid path toward the leaflet 262 can be relatively smooth. It is also contemplated that the liner 270 can be positioned at least partially along the exterior of the inner frame 220 and / or the outer frame 240 such that at least a portion of the liner 270 is radially outward from the struts of the inner frame 220 and / or the outer frame 240 relative to the longitudinal axis of the prosthesis 200. As shown in the example embodiment, the liner 270 can be positioned along the upper side or inlet side of the inner frame 220. The liner 270 can extend from the first edge 264 of the leaflet 262 toward the upper end of the inner frame 220. The liner 270 may also extend below the first edge 264 of the valve leaflet 262 toward the lower end of the inner frame 220. The liner 270 may also move with the shortened portion of the inner frame 220.

[0194] In some embodiments, the liner 270 may extend the full length of the inner frame 220 or the inner frame body 222. In other embodiments, it may extend only along a portion of the length of the inner frame body 222, as shown. In some embodiments, the end of the leaflet 262 may coincide with the end of the liner 270. Additionally, one or more ends of the inner frame body 222 may coincide with the end of the liner 270. As shown in the example embodiment, the end 272 of the liner 270 may be positioned between the upper end of the inner frame 220 and the leaflet 262. The end 272 of the liner 270 may extend above the upper end of the inner frame body 222 and along a portion of the locking connector 232. In some embodiments, the end 272 of the liner 270 may be positioned at or near the uppermost portion of the first or arcuate edge 264 of the leaflet 262 below the upper end of the inner frame body 222.

[0195] Other shapes and configurations may also be used for the valve body 260. In some embodiments, the liner 270 may extend along the length of the leaflet but is not connected to it. In the illustrated embodiment, the liner 270 is attached to the inner frame 220, and at least a portion of the leaflet 262 (such as the first or arcuate edge 264) is attached to the liner 270. Portions of the valve leaflet 262, such as the first edge 264 and / or the connector 268 portion, may also be attached to the inner frame 220. Liner 270 and / or valve leaflets 262 may be attached to inner frame 220 or to each other using any of the fasteners and / or techniques described herein, including but not limited to mechanical fasteners such as stitches, U-bolts, screws, rivets, connecting components (e.g., joints and slots) and any other desired type of mechanical fastener; chemical fasteners such as adhesives and any other desired type of chemical fastener; fastening techniques such as fusion welding, brazing, sintering and any other desired type of fastening technique; and / or combinations of such fasteners and techniques.

[0196] Liner 270 can be constructed in a variety of different ways. Liner 270 can be made into a layer of elastic material, such as woven polyester (e.g., polyethylene terephthalate (PET), polyvalve lactone (PVL)) or any other biocompatible material, such as those that are completely or substantially fluid-impermeable, flexible, stretchable, deformable, and / or elastic. In some embodiments, liner 270 may be made of a material that is more flexible than the valve leaflet material. The upper and / or lower ends of liner 270 (such as end 272) can be straight, curved, or have any other desired configuration. For example, as shown in the example embodiment, liner 270 may have straight edges forming end 272. In other embodiments, end 272 may be patterned to generally correspond to undulations at one end of inner frame 220. Liner 270 may be formed from one or more pieces.

[0197] In another embodiment of the liner 270, the end may extend beyond the inner frame 220 and may be wrapped around it. Therefore, the liner 270 may extend from the inside of the inner frame 220 to the outside of the inner frame 220. The liner 270 may extend completely around the inner frame 220 for 1 / 4, 1 / 3, 1 / 2, or more of the length of the inner frame 220.

[0198] Next reference Figure 2-5The skirt 280 shown may be positioned around and secured to at least a portion of the exterior of the prosthesis 200 (such as, but not limited to, the inner frame 220 and / or the outer frame 240). The skirt 280 may be annular and may extend circumferentially around the prosthesis 200. The skirt 280 may prevent or inhibit backflow of fluid around the prosthesis 200. For example, when the skirt 280 is positioned annularly around the exterior of the prosthesis 200, the skirt 280 may create an axial barrier to the flow of fluid outside the prosthesis 200 when deployed within a body cavity. As shown, the skirt 280 may seal against at least a portion of the tissue surrounding the body cavity. Additionally, the skirt 280 may promote inward tissue growth between the flap assembly 280 and the natural tissue of the body cavity. This may further help prevent blood leakage around the prosthesis 200.

[0199] The skirt 280 may have an upper region 282, a middle region 284, and a lower region 286. The upper region 282 of the skirt 280 may extend along a portion of the exterior of the outer frame 240, such as the upper region 246 of the outer frame 240. The middle region 284 of the skirt 280 may extend along a portion of the exterior of the outer frame 240, such as the middle region 248 of the outer frame 240. The lower region 286 of the skirt 280 may extend along a portion of the exterior of the outer frame 240, such as the lower region 250 of the outer frame 240. Although the skirt 280 is shown extending along the exterior of the outer frame 240, it should be understood that part or all of the skirt 280 may extend along the interior of the outer frame. It should also be understood that although the skirt 280 is shown tautly attached to the outer frame 240, part or all of the skirt 280 may be loosely attached, such that part or all of the skirt 280 is movable relative to the outer frame 240.

[0200] The upper end of the skirt 280 may be located at or near the upper end of the outer frame body 242 and / or the upper end of the inner frame body 222. In some embodiments, the upper end of the skirt 280 may be attached to the end 272 of the lining 270 using any fasteners and / or techniques described herein, including but not limited to mechanical fasteners such as stitches, U-bolts, screws, rivets, connecting members (e.g., joints and grooves) and any other desired type of mechanical fastener; chemical fasteners such as adhesives and any other desired type of chemical fastener; fastening techniques such as fusion welding, brazing, sintering and any other desired type of fastening technique; and / or combinations of such fasteners and techniques. The lower end of the lower region 286 of the skirt 280 may be located at or near the lower end of the lower region 250 of the outer frame body 242. The skirt 280 can be attached to the outer frame 240 and / or the inner frame 220 using any of the fasteners and / or techniques described herein. For example, portions of the skirt 280 can be attached to the struts and / or anchoring structures of the outer frame 240 and / or the inner frame 220 by stitching.

[0201] As shown in the example embodiment, the lower end of the lower region 286 of the skirt 280 may be configured with a generally straight edge that extends circumferentially around the outer frame body 242 and / or the inner frame body 222. It should be understood that other configurations, such as curved edges, may also be used as needed. In some embodiments, the lower end of the lower region 286 of the skirt 280 may follow the shape of the support column along the lower end of the lower region 250 of the outer frame body 242.

[0202] In some embodiments, the skirt 280 may be formed of materials such as knitted polyester (e.g., polyethylene terephthalate (PET), polyvalve lactone (PVL)) or any other biocompatible material such as a fully or substantially fluid-impermeable, flexible, stretchable, deformable, and / or elastic material. The skirt 280 and / or lining 270 may be made of the same or similar materials. As shown in the example embodiments, the skirt 280 may be formed as a separate component. Components may be attached together using any of the fasteners and / or techniques described herein, including but not limited to mechanical fasteners such as stitches, U-bolts, screws, rivets, connecting members (e.g., joints and slots), and any other desired type of mechanical fastener; chemical fasteners such as adhesives and any other desired type of chemical fastener; fastening techniques such as fusion welding, brazing, sintering, and any other desired type of fastening technique; and / or combinations of such fasteners and techniques. For example, the upper region 282 may be a first component, and the middle region 284 and / or the lower region 286 may be a second component. In other embodiments, the skirt 280 may be formed integrally or monolithically. For example, in some embodiments, the upper region 282 of the skirt 280 and the middle region 284 and / or the lower region 286 may be formed integrally or monolithically as a single component.

[0203] In some embodiments, the outer frame 240 may be attached to the inner frame 220 at one or more attachment points using any of the fasteners and / or techniques described herein, including but not limited to mechanical fasteners such as stitches, U-bolts, screws, rivets, connecting members (e.g., joints and slots on the inner frame 220 and outer frame 240), and any other desired type of mechanical fastener; chemical fasteners such as adhesives and any other desired type of chemical fastener; fastening techniques such as fusion welding, brazing, sintering, and any other desired type of fastening technique; and / or combinations of such fasteners and techniques.

[0204] The outer frame 240 can be attached to the inner frame 220 by attaching the skirt 280 to a portion of the inner frame 220 and / or the valve body 260, such as the liner 270, using any of the mechanisms or techniques described herein. In some embodiments, the outer frame 240 can be attached tautly to the inner frame 220 such that little or no relative movement occurs between the outer frame 240 and the inner frame 220 at one or more attachment points. For example, the outer frame 240 can be attached tautly to the inner frame 220, and / or the skirt 280 can be attached tautly to the inner frame 220 and / or the valve body 260. In other embodiments, the outer frame 240 can be attached loosely to the inner frame 220 such that some relative movement occurs between the outer frame 240 and the inner frame 220 at one or more attachment points. For example, the outer frame 240 may be loosely attached to the inner frame 220, and / or the skirt 280 may be loosely attached to the inner frame 220 and / or the valve body 260 to allow relative movement between the outer frame 240 and the inner frame 240.

[0205] Next reference Figure 7-8 An example is provided for an implementation of an outer frame 300 in an expanded configuration. The outer frame 300 may include an outer frame body 302. The longitudinal axis of the outer frame 300 may be defined as a central axis extending through the center of the outer frame 300 between its upper and lower ends. As shown, the outer frame body 302 may have an upper region 304, a middle region 306, and a lower region 308.

[0206] When in a deployment configuration (such as a fully deployed configuration), the outer frame body 302 may have a bulbous shape, wherein the intermediate region 306 is larger than the upper region 304 and the lower region 308. The bulbous shape of the outer frame body 302 advantageously allows the outer frame body 302 to engage with natural valve annulus, natural valve leaflets, or other body cavities, while separating the inlet and outlet from the heart or vascular walls. This can help reduce undesirable contact between the prosthesis using the outer frame 300 and the heart or blood vessels (such as the atrioventricular walls of the heart). The bulbous shape can further enhance the fixation of the outer frame body 302 to the body cavity. For example, in some embodiments, the bulbous shape may allow the intermediate region 306 to extend further radially outward compared to the anchoring structures such as frame anchoring structures 124, 224. In this way, the intermediate region 306 can exert greater radial forces on the tissues of the body cavity and / or can more completely conform to the tissues of the body cavity, such as natural valve annulus and / or natural valve leaflets.

[0207] The upper region 304 of the outer frame body 302 may include a generally longitudinally extending portion 304a and an outwardly extending portion 304b. The outwardly extending portion 304b may extend radially outward away from the longitudinal axis of the outer frame 300. In some embodiments, the outwardly extending portion 246b may extend from the longitudinally extending portion 304a in a direction more perpendicular to the longitudinal axis 202 than parallel and / or in a downward direction. However, it should be understood that the outwardly extending portion 304b may extend from the longitudinally extending portion 304a generally perpendicular to the longitudinal axis and / or in an upward direction. Moreover, it should be understood that the longitudinally extending portion 304a may be omitted.

[0208] At the junction between the longitudinally extending portion 304a and the outwardly extending portion 304b, the outer frame body 302 may include a bend 310. The bend 310 may be about a circumferential axis such that the outwardly extending portion 304b extends in a direction more perpendicular to the longitudinal axis of the outer frame 300 than the longitudinally extending portion 304a. In some embodiments, the bend 310 may generally form an arc having an angle between about 20 degrees and about 90 degrees. For example, as shown in the example embodiment, the arc may have an angle of about 60 degrees. In some embodiments, the bend 310 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 such that the bend 310 forms a circular arc, or it may vary along the length of the bend 310.

[0209] In some embodiments, the outwardly extending portion 304b may form an angle between about 20 degrees and about 70 degrees with a plane perpendicular to the longitudinal axis of the outer frame 300, an angle between about 30 degrees and about 60 degrees with a plane perpendicular to the longitudinal axis of the outer frame 300, an angle between about 40 degrees and about 50 degrees with a plane perpendicular to the longitudinal axis of the outer frame 300, an angle of about 30 degrees with a plane perpendicular to the longitudinal axis of the outer frame 300, any subrange within these ranges, or any other desired angle. In some embodiments, the outwardly extending portion 304b may form an angle less than 70 degrees with a plane perpendicular to the longitudinal axis of the outer frame 200, an angle less than 55 degrees with a plane perpendicular to the longitudinal axis of the outer frame 300, an angle less than 40 degrees with a plane perpendicular to the longitudinal axis of the outer frame 300, an angle less than 25 degrees with a plane perpendicular to the longitudinal axis of the outer frame 300, or less than any other desired angle.

[0210] The middle region 306 of the outer frame body 302 can generally extend downward from the outwardly extending portion 304b of the upper region 304. As shown, the middle region 306 can have a generally bulbous shape, wherein the portion between the upper and lower ends of the middle region 306 has a larger diameter. However, it should be understood that the diameters of the upper end, the lower end, and / or the portion in between can be the same, such that the middle region 306 forms a generally cylindrical 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.

[0211] Although the outer frame body 302 has been described and exemplified as having a circular cross-section, it should be understood that all or part of the outer frame body 302 may have a non-circular cross-section, such as, but not limited to, D-shaped, elliptical, or other oval cross-sectional shapes.

[0212] At the junction between the upper region 304 and the middle region 306, the outer frame body 302 may include a bend 312. The bend 312 may be about a circumferential axis such that the middle region 306 extends in a direction more parallel to the longitudinal axis of the outer frame 300 than the outwardly extending portion 304b of the upper region 304. In some embodiments, the bend 312 may generally form an arc having an angle between about 20 degrees and about 90 degrees. For example, as shown in the example embodiment, the arc may have an angle of about 60 degrees. In some embodiments, the bend 312 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 such that the bend 312 forms a circular arc, or it may vary along the length of the bend 312.

[0213] The lower region 308 of the outer frame body 302 can generally extend downward from the lower end of the intermediate region 306. As shown, the lower region 308 of the outer frame body 302 may have a diameter that decreases from the upper end to the lower end of the lower region 308, such that the lower region 308 is radially inwardly inclined or curved toward the longitudinal axis of the outer frame 300. This radial inward inclination or curvature of the lower region 308 can facilitate the capture of the natural valve leaflet between the outer frame 300 and other parts of the prosthesis using the outer frame 300 (such as anchoring structures). Furthermore, this radial inward inclination or curvature of the lower region 308 can reduce or suppress potential trauma to body cavity tissues such as the natural leaflet and / or the natural valve annulus. For example, the curvature and / or inclination of the lower region 308 can be selected to better conform to the curvature of the tissue located between the outer frame 300 and the anchoring structures of another part of the prosthesis using the outer frame 300.

[0214] The lower region 308 may be bent and / or inclined toward the longitudinal axis of the frame 300, such that the lower end of the lower region 308 may extend in the following directions: at an angle of about 20 degrees to about 80 degrees relative to a plane parallel to the longitudinal axis of the frame 300; at an angle of about 25 degrees to about 70 degrees relative to a plane parallel to the longitudinal axis of the frame 300; at an angle of about 30 degrees to about 60 degrees relative to a plane parallel to the longitudinal axis of the frame 300; and at an angle of about 30 degrees relative to a plane parallel to the longitudinal axis of the frame 300. The lower region 308 may be bent and / or inclined toward the longitudinal axis of the frame 300, such that the lower end of the lower region 308 may extend in a direction generally perpendicular to the longitudinal axis of the frame 300.

[0215] In some embodiments, the outer frame body 302 in the expanded configuration may have a diameter at its widest portion ranging from approximately 30 mm to approximately 60 mm, approximately 35 mm to approximately 55 mm, approximately 40 mm, any subrange within these ranges, or any other desired range. In some embodiments, the outer frame body 302 in the expanded configuration may have a diameter at its narrowest portion ranging from approximately 20 mm to approximately 40 mm, any subrange within these ranges, or any other desired diameter. In some embodiments, the outer frame body 302 in the expanded configuration may have a diameter at the lower end of the lower region 308 ranging from approximately 20 mm to approximately 40 mm, any subrange within these ranges, or any other desired diameter. In some embodiments, in the expanded configuration, the ratio of the diameter of the outer frame body 302 at its widest portion to the diameter of the frame body 302 at its narrowest portion may be approximately 3:1, approximately 5:2, approximately 2:1, approximately 3:2, approximately 4:3, any ratio within these ratios, or any other desired ratio.

[0216] The outer frame body 302 may have a compact construction relative to its radial dimension. In some embodiments, the outer frame body 302 in an expanded configuration may have an axial dimension (i.e., the “height” of the outer frame body 302) between its upper and lower ends as follows: between about 10 mm and about 10 mm, between about 18 mm and about 30 mm, about 20 mm, any subrange of these ranges, or any other desired height. For example, when the frame is in its expanded configuration, the ratio of the diameter of the largest portion of the outer frame body 302 to the height of the outer frame body 302 may 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. Therefore, in some embodiments, the width at the largest portion of the outer frame body 302 may be greater than the height of the outer frame body 302.

[0217] Continue to refer to Figure 7-8The outer frame 300 shown, and the outer frame body 302 may include a plurality of pillars, wherein at least some of the pillars form units 314a-c. Any number of pillar configurations may be used, such as the rings showing undulating pillars forming elliptical, oval, rounded polygonal and teardrop shapes, as well as V-shaped, rhomboid, curved and various other shapes.

[0218] The upper unit 314a may have an irregular hexagonal shape, such as the heart shape in the example. Unit 314a may be formed by a combination of supports. As shown in the example embodiment, the upper part of unit 314a may be formed by a set of circumferentially expandable supports 316a having a Z-shaped or undulating shape forming a repeating "V" shape. The circumferentially expandable supports 316a may be radially inclined or bent outward away from the longitudinal axis of the outer frame 300, such that the upper part of the supports 316a is positioned closer to the longitudinal axis of the outer frame 300 than the lower part of the supports 316a. As shown in the example embodiment, the circumferentially expandable supports may include a bend 310 of the outer frame body 302.

[0219] The lower portion of unit 314a may be formed by a set of circumferentially expandable struts 316b having a zigzag or undulating shape forming a repeating “V” shape. The lower ends or tips of the circumferentially expandable struts 316b may be located at or near the junction of the upper region 304 and the middle region 306. As shown in the example embodiment, the circumferentially expandable strut may include a portion of the curved portion 312 of the outer frame body 302. One or more upper ends or tips of the circumferentially expandable struts 316b may be “free” vertices not connected to the strut. For example, as shown in the example embodiment, every other upper end or tip of the circumferentially expandable strut 316b is a free vertices. However, it should be understood that other configurations may be employed. For example, each upper vertex along the upper end may be connected to a strut.

[0220] The middle and / or lower units 314b-c may have a different shape than the unit 314a of the first row. The middle unit 314b and the lower unit 314c may have a rhomboid or generally rhomboid shape. The rhomboid or generally rhomboid shape may be formed by a combination of struts. The upper part of unit 314b may be formed by the set of circumferentially expandable struts 316b, such that unit 314b shares struts with unit 314a. The lower part of unit 314b may be formed by a set of circumferentially expandable struts 316c. As shown in the example embodiment, one or more circumferentially expandable struts 316c may generally extend in a downward direction and may include a portion of the curved portion 312 of the outer frame body 302. For example, one or more circumferentially expandable struts 316c may be curved, such that the upper part of strut 316c is positioned closer to the longitudinal axis of the outer frame 300 than the portion of strut 316c located between the upper and lower ends of strut 316c. In some implementations, one or more circumferentially expandable struts 316c may extend radially outward from the longitudinal axis of the outer frame 300.

[0221] The upper portion of unit 314c may be formed by the set of circumferentially expandable struts 316c, such that unit 314c shares struts with unit 314b. The lower portion of unit 314c may be formed by a set of circumferentially expandable struts 316d. The circumferentially expandable struts 316d may generally extend in a downward direction. As shown in the example embodiment, the circumferentially expandable struts 316e may be inclined or bent toward the longitudinal axis of the outer frame 300, such that the upper portion of the strut 316d may be positioned closer to the longitudinal axis of the outer frame 300 than the lower portion of the strut 316d. In some embodiments, the circumferentially expandable struts 316d may extend in a direction generally parallel to the longitudinal axis of the outer frame 300.

[0222] As shown in the example embodiments, there can be one row of twelve units 314a, one row of twenty-four units 314b, and one row of twenty-four units 314c. Although each unit 314a-c is shown to have the same shape as the other units 314a-c in the same row, it should be understood that the shapes of the units 314a-c within a row can be different. Furthermore, it should be understood that any number of rows of units can be used, and any number of units can be contained within a row. In some embodiments, the number of units can correspond to the number of anchors or anchor tip segments forming the anchoring structure of the prosthesis using the outer frame 300, such as, but not limited to, 1:1, 2:1, 3:1, 4:1, 5:1, 6:1, and other desired ratios. In some embodiments, all three rows of units 314a-c can have the same number of units. Furthermore, it should be understood that fewer or more rows of units can be used.

[0223] The geometry of units 314a-c allows for shortening of units 314a-c when the outer frame 300 expands. Thus, one or more of units 314a-c can allow for shortening of the outer frame 300 when it expands. Shortening of the outer frame 300 can be used to secure the prosthesis to intracavitary tissue within a body cavity, such as a natural valve, including but not limited to natural valve annulus and / or valve leaflets. For example, expansion of the outer frame 300 can allow it to apply radially outward forces to tissue at or near a natural valve, such as a natural valve annulus and / or valve leaflets.

[0224] As shown in the example embodiments, the outer frame 300 may include a connector 318 extending from a portion of the frame 300 (such as the upper end of the frame body 302). The connector 318 may include eyelets 320. The connector 318 may be advantageously used to couple the outer frame 300 to an inner frame of a prosthesis in which the outer frame 300 is used, such as inner frames 120, 220. For example, sutures may pass through eyelets 320 to couple to the inner frame. In some embodiments, the connector 318 may be used to couple to other components of the prosthesis in which the outer frame 300 is used, such as, but not limited to, the valve body and / or skirt.

[0225] In some embodiments, connector 318 can be advantageously used to couple outer frame 300 to various types of delivery systems. For example, the shape of connector 318 can be used to secure outer frame 300 to a slot-based delivery system. Eyelet 320 can be used to secure outer frame 300 to a tether-based delivery system, such as those that utilize stitches, threads, or fingers to control the delivery of outer frame 300 and prosthesis. This can advantageously facilitate in-situ re-capture and repositioning of outer frame 300 and prosthesis. In some embodiments, outer frame 300 and prosthesis can be used with delivery systems described herein, including but not limited to those described in U.S. Patent Nos. 8,414,644 and 8,652,203 and U.S. Publication No. 2015 / 0238315, all of which are incorporated herein by reference in their entirety. In some embodiments, connector can be positioned at the end of a strut, similar to locking connector 232.

[0226] Next reference Figure 9-10 This example illustrates an implementation of an inner frame 400 in an expanded configuration. The inner frame 400 may include an inner frame body 402. The inner frame 400 may share features related to the above. Figure 2-6 The inner frame 220 described has the same or at least similar features, such as structural and / or functional features. Therefore, reference should be made to the description of the inner frame 220 above.

[0227] As shown in the example embodiments, the inner frame 400 may include a connector 404 extending from the upper end of a portion of the inner frame 400, such as the frame body 402. The inner frame 400 may include eyelets 406. Eyelets 406 may be advantageously used to couple the inner frame 400 to an outer frame, such as outer frames 120, 220, 300, of a prosthesis in which the inner frame 400 is used. For example, sutures may pass through eyelets 406 to couple to eyelets 320 of the outer frame 300. In some embodiments, eyelets 406 may be used to couple to other components of the prosthesis in which the inner frame 400 is used, such as, but not limited to, the valve body and / or skirt.

[0228] In some embodiments, the connector 404 can be advantageously used to couple the inner frame 400 to various types of delivery systems. For example, the shape of the connector 404 can be used to secure the inner frame 400 to a slot-based delivery system. An eyelet 406 can be used to secure the inner frame 400 to a tether-based delivery system, such as those that utilize sutures, threads, or fingers to control the delivery of the inner frame 400 and the prosthesis. This can advantageously facilitate in-situ re-capture and repositioning of the inner frame 400 and the prosthesis. In some embodiments, the inner frame 400 and the prosthesis can be used with the delivery systems described herein, including but not limited to those described in U.S. Patent Nos. 8,414,644 and 8,652,203 and U.S. Publication No. 2015 / 0238315, all of which are incorporated herein by reference in their entirety. In such embodiments, the connector 404 can be omitted advantageously to the axial dimension (i.e., the “height” of the inner frame 400) between the upper and lower ends of the inner frame 400.

[0229] Next reference Figure 33 An embodiment of a prosthesis 1500 in an expanded configuration is illustrated. 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. The prosthesis 1500 may share features that are identical or at least similar to those of other prostheses described herein (such as, but not limited to, prosthesis 100), such as structural and / or functional features.

[0230] Referring first to the inner frame 1520, the inner frame 1520 may include an inner frame body 1522 and an inner frame anchoring structure 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 an overall bulbous shape, such that the diameters of the upper region 1522a and the lower region 1522c are smaller than the diameter of the middle region 1522b. The diameter of the upper region 1522a may be smaller than the diameter of the lower region 1522c. This advantageously allows for the use of a smaller valve body 1560 within the inner frame 1520, while allowing the inner frame body 1522 to have a larger diameter near the connection between the inner frame body 1522 and the inner frame anchoring structure 1524. This larger diameter can reduce the radial distance between the connection and the tip or end of the inner frame anchoring structure 1524. This can advantageously enhance the fatigue resistance of the inner frame anchoring structure 1524 by reducing the length of the cantilever.

[0231] Although the example 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 may be the same, such that the inner frame body 1522 is generally cylindrical along one or more regions. Furthermore, although the example embodiment includes a lower region 1522a with a diameter greater than that of the upper region 1522c, it should be understood that the diameters of the upper region 1522a and the lower region 1522c may be the same, or the diameter of the upper region 1522a may be greater than that of the lower region 1522c. Moreover, although the inner frame body 1522 has been described and exemplified as cylindrical or having a circular cross-section, it should be understood that all or part of the inner frame body 1522 may have a non-circular cross-section, such as, but not limited to, D-shaped, oval, or other oval cross-sectional shapes.

[0232] Next reference Figure 33 The outer frame 1540 shown herein may be attached to the inner frame 1520 using any of the fasteners and / or techniques described herein. Although the outer frame 1540 is illustrated as a separate component from the inner frame 1520, it should be understood that frames 1520 and 1540 may be formed integrally or monolithically.

[0233] As shown in the example embodiment, the outer frame 1540 may include an outer frame body 1542 and an outer frame anchoring structure 1544. The outer frame body 1542 may 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 may have an enlarged shape, wherein the middle region 1542b and the lower region 1542c are larger than the upper region 1542a. The enlarged shape of the outer frame body 1542 may advantageously allow the outer frame body 1542 to engage with the natural valve annulus, natural valve leaflet, or other tissues in the body cavity, while separating the upper end from the heart or blood vessel wall.

[0234] The upper region 1542a of the outer frame body 1542 may include a first portion 1546a and a second portion 1546b. The first portion 1546a may be sized and / or shaped to generally match the size and / or shape of the inner frame 1520. For example, the first portion 1546a may have a curvature that matches the curvature of the upper region 1522a of the inner frame body 1522. The second portion 1546b may extend radially outward away from the inner frame 1520. As shown in the example embodiment, the transition between the first portion 1546a and the second portion 1546b may include a bend such that the second portion 1546b extends radially outward at a larger angle relative to the longitudinal axis.

[0235] The middle region 1542b of the outer frame body 1542 can generally extend downward from the outwardly extending portion 1546b of the upper region 1542a. As shown, the middle region 1542b can have a generally constant diameter from the upper end to the lower end, such that the middle region 1542b forms a generally cylindrical shape. The lower region 1542c of the outer frame body 1542 can generally extend 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 the upper end to the 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 equal, such that the middle region 1542b and the lower region 1542c together form a generally cylindrical shape.

[0236] Although the intermediate region 1542b and the lower region 1542c have been described as cylindrical, it should be understood that the diameters of the upper end, the lower end, and / or the portion in between may be different. For example, the diameter of the portion between the upper and lower ends may be larger than that of the upper and lower ends, such that the intermediate region 1542b and / or the lower region 1542c form an overall bulbous shape. In some embodiments, the diameter of the lower end may be larger than that of the upper end. In other embodiments, the diameter of the upper end may be larger than that of the lower end. Furthermore, although the outer frame body 1542 has been described and exemplified as cylindrical or having a circular cross-section, it should be understood that all or part of the outer frame body 1542 may have a non-circular cross-section, such as, but not limited to, D-shaped, oval, or other oval cross-sectional shapes.

[0237] Continue to refer to Figure 33 The outer frame 1540 shown has an outer frame anchoring structure 1544 that extends outward relative to the longitudinal axis of the prosthesis 1500. As shown in the example embodiment, the outer frame anchoring structure 1544 is attached to the outer frame body 1542 along the upper region 1542a. The outer frame anchoring structure 1544 can be attached to the outer frame body 1542 such that when transitioning from a wrinkled configuration to an expanded configuration, the tip or end of the outer frame anchoring structure 1544 moves radially outward and upward.

[0238] In some embodiments, the outer frame anchoring structure 1544 may be attached to the outer frame body 1542 along a portion having a larger diameter (such as the intermediate region 1542b and / or the second portion 1546b). This can advantageously increase the radial range of the outer frame anchoring structure 1544 while maintaining the same anchor length. Furthermore, in some embodiments, the outer frame anchoring structure 1544 may be attached to the outer frame body 1542 such that the tip or end of the outer frame anchoring structure 1544 moves radially outward and downward when transitioning from a constricted configuration to an expanded configuration. This can advantageously facilitate alignment of the prosthesis 1500. For example, in cases where a portion of the prosthesis 1500 is positioned too deep in the ventricle, the outer frame anchoring structure 1544 may contact the tissue of the natural mitral valve and apply force to at least elevate that portion of the prosthesis 1500. In some embodiments, the outer frame anchoring structure 1544 may include one or more individual anchors to allow individual anchors to operate independently of other anchors. In some embodiments, the outer frame anchoring structure 1544 may be relatively flexible. For example, the outer frame anchoring structure 1544 may include a coupling... Figure 50 The described anchoring structure 2600 has a serpentine shape.

[0239] The outer frame 1540 (such as the outer frame body 1542) can be used to attach or secure the prosthesis 1500 to a natural valve, such as a natural mitral valve. For example, the intermediate region 1542b of the outer frame body 1542 and / or the outer anchoring structure 1544 can be positioned to contact or engage the natural valve annulus, tissue beyond the natural valve annulus, natural valve leaflets, and / or other tissue at or around the implantation site 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 structure 1524 such that body cavity tissue such as natural valve leaflets and natural valve annulus positioned between the outer frame body 1542 and the inner frame anchoring structure 1524 can be engaged or clamped to further secure the prosthesis 1500 to the tissue.

[0240] Continue to refer to Figure 33 The prosthesis 1500 shown has a valve body 1560 attached to the inner frame 1520 inside 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 inhibit blood flow through the valve body 1560 in a second direction.

[0241] The valve body 1560 may include a plurality of leaflets 1562, such as three leaflets 1562, which are joined at the suture site. The valve body 1560 may include one or more intermediate members 1564. The intermediate member 1564 may be positioned between a portion or all of the leaflet 1562 and the inner frame 1520 such that at least a portion of the leaflet 1562 is coupled to the frame 1520 via the intermediate member 1564. In this way, a portion or all of the leaflet 1562 at the suture site and / or the arcuate edge of the leaflet 1562 is not directly coupled or attached to the inner frame 1520, but is indirectly coupled or "floats" within the inner frame 1520. For example, a portion or all of the leaflet 1562 near the suture site and / or the arcuate edge of the leaflet 1562 may be radially inwardly spaced from the inner surface of the inner frame 1520. By using one or more intermediate components 1564, the valve leaflet 1562 can be attached to a non-cylindrical frame 1520 and / or a frame 1520 with a diameter larger than that of the valve leaflet 1562. Further details of the floating valve concept can be found in U.S. Patent Application No. 15 / 653,390, filed July 18, 2017, entitled REPLACEMENT HEART VALVE PROSTHESIS, the entire contents of which are incorporated herein by reference.

[0242] Next reference Figure 33The outer skirt 1580 shown may be attached to the inner frame 1520 and / or the outer frame 1540. As shown, the outer skirt 1580 may be positioned on and secured to a portion 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 member 1564. For example, the skirt 1580 may be attached to the inflow region of the intermediate member 1564. As shown, the outer skirt 1580 may follow the contour of the outer frame 1540; however, it should be understood that at least a portion of the skirt 1580 may be spaced apart from at least a portion of the inner frame 1520 and the outer frame 1540.

[0243] Next reference Figure 33 The inner skirt 1590 shown can be attached to the valve body 1560 and the outer skirt 1580. As shown, a first end of the inner skirt 1590 can be coupled to the valve body 1560 along a portion of the valve body 1560 near the inner frame 1520. A second end of the inner skirt 1590 can be attached to a lower region of the outer skirt 1580. This creates a smooth surface beneath each leaflet. This beneficially enhances hemodynamics by allowing blood to circulate more freely and reducing stagnant areas. In some embodiments, the inner skirt 1590 can advantageously reduce contact between the outer frame body 1542 and the inner frame body 1522.

[0244] Although the prosthesis 1500 has been described as including an inner frame 1520, an outer frame 1540, a valve body 1560, and skirts 1580 and 1590, it should be understood that the prosthesis 1500 does not need to include all components. For example, in some embodiments, the prosthesis 1500 may include the inner frame 1520, the outer frame 1540, and the valve body 1560, while omitting the skirt 1580. Furthermore, although the components of the prosthesis 1500 have been described and exemplified as separate components, it should be understood that one or more components of the prosthesis 1500 may be formed integrally or monolithically. For example, in some embodiments, the inner frame 1520 and the outer frame 1540 may be formed integrally or monolithically as a single component.

[0245] Next reference Figures 34-35 An embodiment of a prosthesis 1600 in an expanded configuration is illustrated. 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. The prosthesis 1600 may share features that are identical or at least similar to those of other prostheses described herein (such as, but not limited to, prostheses 100 and 1500), such as structural and / or functional features.

[0246] First refer to Figures 34-35The outer frame 1640 shown herein may be attached to the inner frame 1620 using any of the fasteners and / or techniques described herein. Although the outer frame 1640 is illustrated as a separate component from the inner frame 1620, it should be understood that frames 1620 and 1640 may be formed integrally or in a single unit.

[0247] As shown in the example embodiment, the outer frame 1640 may include an outer frame body 1642 and an outer frame anchoring structure 1644. The outer frame body 1642 may 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 may 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 example embodiment, the upper region 1642a of the outer frame body 1642 may include one or more struts that generally match the size and / or shape of the struts of the inner frame 1620. This can locally reinforce portions of the prosthesis 1600 by effectively increasing the wall thickness of the combined struts. Further details regarding the reinforced portions of the prosthesis can be found in U.S. Application No. 15 / 653,390, filed July 18, 2017, entitled REPLACEMENT HEART VALVEPROSTHESIS, the entire contents of which are incorporated herein by reference.

[0248] When in an expanded configuration (such as a fully expanded configuration), the outer frame body 1642 may have the features described above. Figure 33 The outer frame body 1542 is described as having a similar shape. As shown, the diameters of the middle region 1642b and the lower region 1642c may be larger than the diameter of the upper region 1642a. The upper region 1642a of the outer frame body 1642 may have a diameter that decreases from the lower end to the upper end, such that the upper region 1642a is radially inclined or curved inward toward the longitudinal axis of the prosthesis 1600. Although the outer frame body 1642 has been described and exemplified as cylindrical or having a circular cross-section, it should be understood that all or part of the outer frame body 1642 may have a non-circular cross-section, such as, but not limited to, D-shaped, oval, or other oval cross-sectional shapes.

[0249] Continue to refer to Figure 34 The outer frame 1600 shown, and the outer frame body 1642 may include a plurality of pillars, wherein at least some of the pillars form units 1646a-c. Any number of pillar configurations may be used, such as the rings showing undulating pillars forming elliptical, oval, rounded polygonal and teardrop shapes, as well as V-shaped, rhomboid, curved and various other shapes.

[0250] The ascending unit 1646a may have an irregular octagonal shape, such as a heart shape. This larger shape provides additional space for the outer frame anchoring structure 1644. This additional space advantageously allows the outer frame 1640 to maintain a smaller profile when folded. The unit 1646a may be formed by an assembly of struts. As shown in the example embodiment, the upper portion of the unit 1646a may be formed by a set of circumferentially expandable struts 1648a, which have a Z-shaped or undulating shape forming a repeating "V" shape. The struts 1648a may extend radially outward from the upper end to the lower end. These struts may generally match the size and / or shape of the struts of the inner frame 1620.

[0251] The middle portion of unit 1646a may be formed by a set of supports 1648b, which extend downward from the bottom end of each "V" shape. The supports 1648b may extend radially outward from the top to the bottom. The portion of unit 1646a extending upward from the bottom end of the supports 1648b can be considered as the basic non-shortened portion of the outer frame 1640.

[0252] The lower portion of unit 1646a may be formed by a set of circumferentially expandable struts 1648c, each strut having a zigzag or undulating shape forming a repeating “V” shape. As shown in the example embodiment, struts 1648c may include curvature such that the lower end of strut 1648c extends more parallel to the longitudinal axis than the upper end of strut 1648c. One or more upper ends or tips of the circumferentially expandable struts 1648c may be “free” vertices not connected to the struts. For example, as shown in the example embodiment, every other upper end or tip of the circumferentially expandable strut 1648b is a free vertice. However, it should be understood that other configurations may be used. For example, each upper vertex along the upper end may be connected to a strut.

[0253] The middle and / or lower rows of cells 1646b-c may have a different shape than the first row of cells 1646a. The middle row of cells 1646b and the lower rows of cells 1646c may have a rhomboid or generally rhomboid shape. The rhomboid or generally rhomboid shape may be formed by combining pillars.

[0254] The upper portion of unit 1646b may be formed by the set of circumferentially expandable struts 1648c, such that unit 1646b shares struts with unit 1646a. The lower portion of unit 1646b may be formed by a set of circumferentially expandable struts 1648d. As shown in the example embodiment, one or more circumferentially expandable struts 1648d may extend generally in a downward direction and generally parallel to the longitudinal axis of the outer frame 1640.

[0255] The upper part of unit 1646c can be formed by the set of circumferentially expandable supports 1648d, such that unit 1646c shares supports with unit 1646b. The lower part of unit 1646c can be formed by a set of circumferentially expandable supports 1648e. The circumferentially expandable supports 1648e can generally extend in a downward direction.

[0256] As shown in the example implementation, there can be rows of nine units 1646a and rows of eighteen units 1646b-c. Although each unit 1646a-c is exemplified as having the same shape as the other units 1646a-c in the same row, it should be understood that the shapes of units 1646a-c within a row can be different. Moreover, it should be understood that any number of rows of units can be used, and any number of units can be contained in a row.

[0257] Continue to refer to Figures 34-35 The outer frame 1640 may include an outer frame anchoring structure 1644. The outer frame anchoring structure 1644 may include one or more individual anchor members 1644a, each having a tip or end 1644b. As shown, the outer frame anchoring structure 1644 includes nine anchor members; however, it should be understood that fewer or more anchor members may be used. For example, the outer frame anchoring structure 1644 may include three anchor members 1644a.

[0258] As shown, anchor 1644a extends from the upper part of unit 1646a, such as the upper apex of unit 1646a. Anchor 1644a may extend downward. Anchor 1644a may be attached to the outer frame body 1642 such that when changing from a wrinkled configuration to an expanded configuration, the tip or end 1644b of anchor 1644a moves radially outward and upward.

[0259] In some embodiments, one or more anchors 1644a may be attached to the outer frame body 1642 along the strut 1648c. For example, the anchor 1644a may extend from one or more free apexes. The anchor 1644a may be attached to the outer frame body 1642 such that when transitioning from a wrinkled configuration to an expanded configuration, the tip or end 1644b of the anchor 1644a moves radially outward and downward. This can advantageously facilitate the alignment of the prosthesis 1600.

[0260] As shown in the example embodiment, the outer frame 1600 may include a set of eyelets 1650. The upper set of eyelets 1650 may extend from the upper region 1642a of the outer frame body 1642. As shown, the upper set of eyelets 1650 may extend from the upper portion of unit 1646a, such as the upper apex of unit 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 may include one or more eyelets corresponding to eyelets 2150. In such embodiments, the inner frame 1620 and the outer frame 1640 can be attached together via eyelets 1650 and corresponding eyelets on the inner frame 1620. For example, the inner frame 1620 and the outer frame 1640 can be sewn together via said eyelets or attached by other means such as mechanical fasteners (e.g., screws, rivets, etc.).

[0261] As shown, the set of eyelets 1650 may include two eyelets extending in series from each “V”-shaped strut. This reduces the possibility 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. Moreover, it should be understood that fewer or more eyelets may extend from the “V”-shaped struts.

[0262] The outer frame 1640 may include a set of locking connectors 1652 extending from or near the upper end of the upper region 1642a. As shown, the locking connectors 1652 may extend upward from this set of eyelets 1650. The outer frame 1640 may include twelve locking connectors 1652; however, it should be understood that more or fewer locking connectors may be used. Each locking connector 1652 may include a longitudinally extending post 1652a. At the upper end of the post 1652a, the locking connector 1652 may include an enlarged head 1652b. As shown, the enlarged head 1652b may have a semi-circular or semi-elliptical shape, forming a “mushroom” shape together with the post 1652a. The locking connector 1652 may include an eyelet 1652c that can be positioned through the enlarged head 1652b. It should be understood that the locking connector 1652 may include eyelets at other locations, or may include more than one eyelet.

[0263] The locking connector 1652 can be advantageously used with a variety of delivery systems. For example, the shape of the strut 1652a and the enlarged head 1652b can be used to secure the outer frame 1640 to a slot-based delivery system. Eyelets 1652c and / or 1650 can be used to secure the outer frame 1640 to a tether-based delivery system, such as those that utilize stitches, threads, or fingers to control the delivery of the outer frame 1640 and the prosthesis 1600. This can advantageously facilitate in-situ re-capture and repositioning of the outer frame 1640 and the prosthesis 1600. In some embodiments, the prosthesis 1600 can be used with the delivery systems described herein, including, but not limited to, those described in U.S. Patent Nos. 8,414,644 and 8,652,203 and U.S. Publication No. 2015 / 0238315, the entire contents of each of which are hereby incorporated by reference and are a part of this specification.

[0264] The outer frame 1640 (such as the outer frame body 1642) can be used to attach or secure the prosthesis 1600 to a natural valve, such as a natural mitral valve. For example, the intermediate region 1642b of the outer frame body 1642 and / or the outer anchoring structure 1644 can be positioned to contact or engage the natural valve annulus, tissue beyond the natural valve annulus, natural valve leaflets, and / or other tissue at or around the implantation site 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 structure 1624 such that body cavity tissue such as natural valve leaflets and / or natural valve annulus positioned between the outer frame body 1642 and the inner frame anchoring structure 1624 can be engaged or clamped to further secure the prosthesis 1600 to the tissue. As shown, the inner frame anchoring structure 1624 includes nine anchors; however, it should be understood that fewer or more anchors may be used. In some embodiments, the number of individual anchors can be selected as a multiple of the number of fusions of the valve body 1660. For example, for a valve body 1660 with three fusions, the inner frame anchoring structure 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 fusions of the valve body 1660.

[0265] Continue to refer to Figures 34-35 The prosthesis 1600 shown has a valve body 1660 attached to the inner frame 1620 inside 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 inhibit blood flow through the valve body 1660 in a second direction.

[0266] The valve body 1660 may include a plurality of leaflets 1662, such as three leaflets 1662, which are joined at the commissure. The valve body 1660 may include one or more intermediate components 1664. The intermediate component 1664 may be positioned between a portion or all of the leaflet 1662 and the inner frame 1620 such that at least a portion of the leaflet 1662 is coupled to the frame 1620 via the intermediate component 1664. In this way, a portion or all of that portion of the leaflet 1662 at the commissure and / or the arcuate edge of the leaflet 1662 is not directly coupled or attached to the inner frame 1620 but is indirectly coupled or “floats” within the inner frame 1620. Further details of the floating valve concept can be found in U.S. Application No. 15 / 653,390, filed July 18, 2017, entitled REPLACEMENT HEART VALVEPROSTHESIS, the entire contents of which are incorporated herein by reference.

[0267] Next reference Figure 34 The outer skirt 1680 shown 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 outer frame 1640. The inner skirt 1690 may be attached to the valve body 1660 and the outer skirt 1680. As shown, a first end of the inner skirt 1690 may be coupled to the valve body 1660 along a portion of the valve body 1660 near the inner frame 1620. A second end of the inner skirt 1690 may be attached to a lower region of the outer skirt 1680. In this way, a smooth surface can be formed beneath each leaflet. This advantageously enhances hemodynamics by allowing blood to circulate more freely and reducing stagnant areas.

[0268] Although the prosthesis 1600 has been described as including an inner frame 1620, an outer frame 1640, a valve body 1660, and skirts 1680 and 1690, it should be understood that the prosthesis 1600 does not need to include all components. For example, in some embodiments, the prosthesis 1600 may include the inner frame 1620, the outer frame 1640, and the valve body 1660, while omitting the skirt 1680. Furthermore, although the components of the prosthesis 1600 have been described and exemplified as separate components, it should be understood that one or more components of the prosthesis 1600 may be formed integrally or monolithically. For example, in some embodiments, the inner frame 1620 and the outer frame 1640 may be formed integrally or monolithically as a single component.

[0269] Next reference Figure 36An example is provided of an embodiment of an inner frame 1700 in an expanded configuration. The inner frame 1700 may include an inner frame body 1702, an inner frame anchoring structure 1704, and / or a set of locking connectors 1712. Locking connectors 1712 may include features similar to other locking connectors described herein. As shown in the example embodiment, the tip or end of the inner frame anchoring structure 1704 may include two or more prongs extending in different directions. This advantageously increases the tissue contact surface of the tip or end, particularly when used in conjunction with a covering or padding.

[0270] The inner frame body 1702 may have an upper region 1702a, a middle region 1702b, and a lower region 1702c. The inner frame body 1702 may have a shape similar to that described above in conjunction with inner frame bodies 1520 and 1620. As shown, the inner frame body 1702 may have an overall bulbous shape, such that the diameters of the upper region 1702a and the lower region 1702c are smaller than the diameter of the middle region 1702b. The diameter of the upper region 1702a may be smaller than the diameter of the lower region 1702c.

[0271] Although the example inner frame body 1702 is bulbous, it should be understood that the diameters of the upper region 1702a, the middle region 1702b, and / or the lower region 1702c may be the same, such that the inner frame body 1702 is generally cylindrical along one or more regions. Furthermore, although the example embodiment includes a lower region 1702a with a diameter greater than that of the upper region 1702c, it should be understood that the diameters of the lower region 1702a and the upper region 1702c may be the same, or the diameter of the upper region 1702a may be greater than that of the lower region 1702c. Moreover, although the inner frame body 1702 has been described and exemplified as cylindrical or having a circular cross-section, it should be understood that all or part of the inner frame body 1702 may have a non-circular cross-section, such as, but not limited to, D-shaped, oval, or other oval cross-sectional shapes.

[0272] The inner frame body 1702 may include a plurality of pillars, wherein at least some of the pillars form units 1706a-c. Any number of pillar configurations may be used, such as rings showing undulating pillars forming elliptical, oval, rounded polygonal and teardrop shapes, as well as V-shaped, rhomboid, curved and various other shapes.

[0273] The ascending unit 1706a may have an elongated hexagonal shape. Unit 1706a can be formed by an assembly of struts. As shown in the example embodiment, the upper portion of unit 1706a may be formed by a set of circumferentially expandable struts 1708a, which have a Z-shaped or undulating shape forming a repeating "V" shape. The struts 1708a may extend radially outward from the upper end to the lower end.

[0274] The central portion of unit 1706a may be formed by a set of eyelets 1710 extending downward from the bottom end of each "V" shape. The eyelets 1710 may extend radially outward from top to bottom. The eyelets 1710 can be used to attach various components to the inner frame 1700. In some embodiments, the eyelets 1710 can be used to attach the inner frame 1700 to an outer frame. For example, the outer frame may be similar to an outer frame 1640 having eyelets 1650. This attachment location may be lower than the attachment location exemplified by the prosthesis 1600. This allows for the use of a more axially compact outer frame. In some embodiments, the eyelets 1710 can be used to attach the valve body to the inner frame 1700.

[0275] The portion of unit 1706a extending upward from the bottom end of eyelet 1710 can be considered as the basic non-shortened portion of the inner frame 1700. Although eyelet 1710 is used, it should be understood that a support can be used in place of eyelet 1710 or in combination with eyelet 1710.

[0276] The lower portion of unit 1706a may be formed by a set of circumferentially expandable struts 1708b, which have a Z-shaped or undulating shape forming a repeating “V” shape. As shown in the example embodiment, struts 1708b may include curvature such that the lower end of strut 1708b extends more parallel to the longitudinal axis than the upper end of strut 1708b.

[0277] The middle and / or lower units 1706b-c may have a different shape than the first unit 1706a. The middle unit 1706b and the lower unit 1706c may have a rhomboid or generally rhomboid shape. The rhomboid or generally rhomboid shape may be formed by combining the supports.

[0278] The upper portion of unit 1706b may be formed by the set of circumferentially expandable struts 1708b, such that unit 1706b shares struts with unit 1706a. The lower portion of unit 1706b may be formed by a set of circumferentially expandable struts 1708c. As shown in the example embodiment, one or more circumferentially expandable struts 1708c may extend generally in a downward direction and generally parallel to the longitudinal axis of the outer frame 1640.

[0279] The upper part of unit 1706c may be formed by the set of circumferentially expandable supports 1708c, such that unit 1706c shares supports with unit 1706b. The lower part of unit 1706c may be formed by the set of circumferentially expandable supports 1708d. The circumferentially expandable supports 1708d may generally extend in a downward direction and / or radially inward direction.

[0280] As shown in the example implementation, there can be nine cells in each row of cells 1706a-c. Although each cell 1706a-c is shown to have the same shape as the other cells 1706a-c in the same row, it should be understood that the shapes of cells 1706a-c within a row can be different. Moreover, it should be understood that any number of rows of cells can be used, and any number of cells can be contained in a row.

[0281] Next reference Figure 37 An embodiment of an outer frame 1800 in an expanded configuration is illustrated. The outer frame 1800 may include an outer frame body 1802 and / or a locking connector 1812. The locking connector 1812 may include features similar to other locking connectors described herein.

[0282] When in an expanded configuration (such as a fully expanded configuration), the outer frame body 1802 may have the features described above. Figure 33 and 34 The outer frames 1540 and 1640 described in -35 have similar shapes. As shown, the diameters of the middle region 1802b and the lower region 1802c may be larger than the diameter of the upper region 1802a. The diameter of the upper region 1802a of the outer frame body 1802 may increase from the top to the bottom, such that the upper region 1802a is radially outwardly inclined or bent away from the longitudinal axis of the outer frame 1800. Although the outer frame body 1802 has been exemplified as having a circular cross-section, it should be understood that all or part of the outer frame body 1802 may have a non-circular cross-section, such as, but not limited to, D-shaped, oval, or other oval cross-sectional shapes.

[0283] The outer frame body 1802 may include a plurality of pillars, wherein at least some of the pillars form units 1804a-b. Any number of pillar configurations may be used, such as rings showing undulating pillars forming elliptical, oval, rounded polygonal and teardrop shapes, as well as V-shaped, rhomboid, curved and various other shapes.

[0284] The upper region 1802a may include an elongated strut 1806a. The elongated strut 1806a may extend radially outward from the longitudinal axis of the outer frame 1802. The elongated strut 1806a may include a bend 1808 to orient the upper part of the strut 1806a in a direction more parallel to the longitudinal axis. The use of the elongated strut 1806a can reduce the change in axial length when the outer frame 1800 transitions from a corrugated configuration to an expanded configuration.

[0285] In some embodiments, the elongated strut 1806a can advantageously suppress radial displacement and / or forces experienced by other portions of the outer frame body 1800. For example, the elongated strut 1806a can suppress radial displacement and / or forces caused by compression of the intermediate region 1802b and / or the lower region 1802c during phases of the cardiac cycle. When the outer frame 1800 is positioned within the natural mitral valve, these compressive forces can be periodically applied by the natural mitral valve annulus during phases of the cardiac cycle. The suppression of such displacement and / or forces resulting from the elongated strut 1806a can reduce forces applied to the inner frame that could cause undesirable movement and / or deformation of the inner frame. The amount of suppression can be selected by adjusting the width, length, taper, material, and other properties of the elongated strut 1806a.

[0286] The ascending unit 1804a may have a rhomboid or generally rhomboid shape. As shown in the example embodiment, the upper portion of unit 1804a may be formed by a set of circumferentially expandable struts 1806b having a Z-shaped or undulating shape forming a repeating “V”. One or more upper ends or tips of the circumferentially expandable struts 1806b may be “free” vertices not connected to the struts. For example, as shown in the example embodiment, every other upper end or tip of the circumferentially expandable strut 1806b is a free vertice. However, it should be understood that other configurations may be used. For example, each upper vertex along the upper end may be connected to a strut. The lower portion of unit 1804a may be formed by a set of circumferentially expandable struts 1806c having a Z-shaped or undulating shape forming a repeating “V”. Although the outer frame 1800 is shown as not having an anchoring structure, it should be understood that the anchoring structure may be incorporated into the outer frame 1800 in a manner similar to that described in connection with other outer frames herein. For example, the anchoring structure can extend from one or more free vertices of the circumferentially expandable strut 1806b.

[0287] The upper part of unit 1804b can be formed by the set of circumferentially expandable supports 1806c, such that unit 1804b shares supports with unit 1804a. The lower part of unit 1804b can be formed by the set of circumferentially expandable supports 1806d.

[0288] As shown in the example implementation, there can be a row of eighteen cells 1804a-b. Although each cell 1804a-b is shown to have the same shape as the other cells 1804a-b in the same row, it should be understood that the shapes of the cells 1804a-b within a row can be different. Moreover, it should be understood that any number of rows of cells can be used, and any number of cells can be contained in a row.

[0289] As shown in the example embodiments, the outer frame 1800 may include a set of eyelets 1810. Eyelets 1810 may extend from the upper region 1802a of the outer frame body 1802. As shown, eyelets 1810 may extend from the upper end of the strut 1806a. In some embodiments, eyelets 1810 may be used to attach the outer frame 1800 to an inner frame. For example, the inner frame may be similar to inner frames 1620 and / or 1700 having eyelets 1710. This may allow for the use of a more axially compact outer frame. In some embodiments, eyelets 1710 may be used to attach a valve body to the inner frame 1700. In some embodiments, the upper set of eyelets 1810 may be used to attach the outer frame 1800 to a delivery system. For example, sutures or tethers of the delivery system may be attached to or pass through the eyelets 1810.

[0290] Next reference Figure 38A An example is provided of an embodiment of a prosthesis 1900 in an expanded configuration. The prosthesis 1900 may include an inner frame 1920, an outer frame 1940, a valve body 1960, and one or more skirts, such as an outer skirt 1980 and an inner skirt 1990. The prosthesis 1900 may share features that are the same as or at least similar to those of other prostheses described herein, such as structural and / or functional features.

[0291] Referring first to the inner frame 1920, the inner frame 1920 may include an inner frame body 1922 and an inner frame anchoring structure 1924. The inner frame body 1922 may have an upper region 1922a, a middle region 1922b, and a lower region 1922c. As shown, the inner frame body 1922 may have a generally cylindrical shape. The inner frame body 1922 may include a bend 1926 along the lower region 1922c of the inner frame body 1920, such that region 1928 of the inner frame body 1920 tapers radially inward toward the longitudinal axis of the prosthesis 1900. The shape of region 1928 may match the shape of a portion of the outer frame 1940.

[0292] Although the example inner frame body 1922 is generally cylindrical, it should be understood that the diameters of the upper region 1922a, the middle region 1922b, and / or the lower region 1922c may be different. For example, in some embodiments, the diameter of the middle region 1922a may be larger than that of the upper region 1922b and the lower region 1922c, such that the frame body 1922 has a generally bulbous shape. Furthermore, although the inner frame body 1922 has been described and exemplified as cylindrical or having a circular cross-section, it should be understood that all or part of the inner frame body 1922 may have a non-circular cross-section, such as, but not limited to, D-shaped, oval, or other oval cross-sectional shapes.

[0293] Next reference Figure 38AThe outer frame 1940 shown herein may be attached to the inner frame 1920 using any of the fasteners and / or techniques described herein. Although the outer frame 1940 is illustrated as a separate component from the inner frame 1920, it should be understood that frames 1920 and 1940 may be formed integrally or monolithically.

[0294] As shown in the example embodiment, the outer frame 1940 may include an outer frame body 1942 and an outer frame anchoring structure 1944. The outer frame body 1942 may have an upper region 1942a, a middle region 1942b, and a lower region 1942c. When in an expanded configuration, such as a fully expanded configuration, the outer frame body 1942 may have an enlarged shape, wherein the upper region 1942a and the middle region 1942b are larger than the lower region 1942c. The enlarged shape of the outer frame body 1942 may advantageously allow the outer frame body 1942 to engage with the natural valve annulus, natural valve leaflet, or other tissues of the body cavity, while separating the upper end from the heart or blood vessel wall.

[0295] As shown in the example embodiment, the lower region 1942c of the outer frame body 1942 can be attached to the lower region 1922c of the inner frame body 1922. This can provide significant advantages, particularly regarding the geometry of the prosthesis 1900 when it is in a folded or wrinkled configuration. For example, in an embodiment where the outer frame body 1942 can be shortened, any increase in axial length of the outer frame body 1942 when folded occurs upward relative to the lower regions 1922c, 1942c to which the frame body is attached. In this way, regardless of the axial length of the outer frame body 1942 in a folded or wrinkled configuration, it is prevented that the outer frame body 1942 extends beyond the inner frame anchoring structure 1922 when folded or wrinkled.

[0296] The lower region 1942c of the outer frame body 1942 may include region 1946. Region 1946 may extend radially inward toward the longitudinal axis of the prosthesis 1900. As shown in the example embodiment, a portion of region 1946 may be sized and / or shaped to generally match the size and / or shape of region 1928 of the inner frame 1920. This advantageously enhances the fixation of the outer frame 1940 to the inner frame 1920 by providing a larger area where the outer frame 1940 can be attached to the inner frame 1920. Furthermore, by bending region 1928 of the inner frame 1920 to match the shape of region 1946 of the outer frame 1940, the fatigue resistance of the outer frame 1940 can be enhanced because the lower end of the outer frame 1940 does not need to be significantly bent to match the geometry of the inner frame 1920.

[0297] The middle region 1942b of the outer frame body 1942 can generally extend upward from the lower region 1942c. As shown, the middle region 1942b can have a generally constant diameter from top to bottom, thus forming a generally cylindrical shape. The upper region 1942a of the outer frame body 1942 can generally extend upward from the lower end of the middle region 1942b. As shown, the upper region 1942a of the outer frame body 1942 can have a generally constant diameter from top to bottom, thus forming a generally cylindrical shape. Simultaneously, the diameters of the middle region and the upper region 1942a are generally equal, so that the middle region 1942b and the upper region 1942a together form a generally cylindrical shape. It should be understood that the diameters of the upper end, the lower end, and / or the portions in between can be different.

[0298] For example, the diameter of the portion between the upper and lower ends can be larger than both the upper and lower ends, such that the intermediate region 1942b and / or the lower region 1942a form an overall 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.

[0299] As another example, the diameter of the upper end of the upper region 1942a may be larger than the diameter of the lower end of the upper region 1942a, such that the upper region 1942a extends radially outward away from the longitudinal axis of the prosthesis 1900. This can advantageously enhance fixation and / or stability when the prosthesis 1900 is positioned within a natural valve (e.g., a natural mitral valve). For example, when the prosthesis 1900 is positioned within a natural mitral valve, the upper region 1942a may extend radially outward on the atrial side of the natural mitral valve annulus. This can inhibit the movement of the prosthesis 1900 into the left ventricle during phases of the cardiac cycle (e.g., diastole). In some embodiments, the upper end may be increased to a diameter similar to or larger than the diameter formed around the tip or end 1924b of the inner frame anchoring structure 1924. In some embodiments, the upper region 1942a may extend generally perpendicular to the intermediate region 1942b to form a flange.

[0300] Furthermore, although the outer frame body 1942 has been described and exemplified as cylindrical or having a circular cross-section, it should be understood that all or part of the outer frame body 1942 may have a non-circular cross-section, such as, but not limited to, D-shaped, oval, or other oval cross-sectional shapes.

[0301] Continue to refer to Figure 38AThe outer frame 1940 shown has an outer frame anchoring structure 1944 that extends outward relative to the longitudinal axis of the prosthesis 1900. As shown in the example embodiment, the outer frame anchoring structure 1944 is attached to the outer frame body 1942 along the upper region 1942a. The outer frame anchoring structure 1944 can be attached to the outer frame body 1942 such that its tip or end moves radially outward and downward when transitioning from a wrinkled configuration to an expanded configuration; however, it should be understood that the outer frame anchoring structure 1944 can be attached to the outer frame body 1942 such that its tip or end moves radially outward and upward when transitioning from a wrinkled configuration to an expanded configuration. The radial extent of the outer frame anchoring structure 1944 may be generally the same as the radial extent of the inner frame anchoring structure 1924. Although the anchoring structure 1944 is shown attached to the outer frame body 1942, it should be understood that the anchoring structure 1944 may be attached to the inner frame body 1922. Furthermore, it should be understood that the anchoring structure 1944 may be one or more barbs or penetrating structures. The barbs may be angled upwards, angled downwards, and / or vertical. Although shown extending along the upper region of the outer frame body 1942, it should be understood that such barbs or other penetrating structures may extend along other regions of the outer frame body 1942.

[0302] Similar to other prostheses described herein, components of the outer frame 1940 can be used to attach or secure the prosthesis 1900 to a natural valve, such as a natural mitral valve. For example, the intermediate region 1942b of the outer frame body 1942 and / or the outer anchoring structure 1944 can be positioned to contact or engage the natural valve annulus, tissue beyond the natural valve annulus, natural valve leaflets, and / or other tissue at or around the implantation site during one or more phases of the cardiac cycle, such as systole and / or diastole. As another example, the outer frame body 1942 can be sized and positioned relative to the inner frame anchoring structure 1924 such that body cavity tissue, such as natural valve leaflets and / or natural valve annulus, positioned between the outer frame body 1942 and the inner frame anchoring structure 1924, can be engaged or clamped to further secure the prosthesis 1900 to the tissue. As shown in the example embodiment, the contour of the outer frame 1940 can generally match the contour of the inner frame anchoring structure 1924. This can advantageously enhance the seal along the outer frame 1940 when tissues (such as leaflets) are trapped between the outer frame 1940 and the inner frame anchoring structure 1924. Even if no tissues such as leaflets are trapped between the outer frame 1940 and the inner frame anchoring structure, this can still advantageously enhance the seal along the outer frame 1940.

[0303] The shape of the outer frame body 1942 in the example can enhance the fixation of the prosthesis 1900. For example, as Figure 38BAs shown, in some cases where the prosthesis 1900 is positioned within the natural mitral valve, the outer frame 1940 can be compressed in such a way that the region above the valve annulus 40 is further radially inward than the region below the valve annulus 40. This allows the outer frame 1940 to exert force on the natural leaflet and / or the natural mitral valve annulus 40 in a direction at least toward the atrium. This force can generate a reaction force that can tend to push the outer frame 1940 and the prosthesis 1900 toward the ventricle. In embodiments where the inner frame anchoring structure 1924 contacts the valve annulus 40, this can reduce the systolic load applied to the inner frame anchoring structure 1924 during systole. This can advantageously reduce and distribute fatigue load on the inner frame anchoring structure 1924. Furthermore, this reaction force can reduce the likelihood of the prosthesis 1900 moving toward the atrium during systole.

[0304] However, it should be understood that the outer frame 1900 can take other shapes. For example, in some cases where the prosthesis 1900 is positioned within the natural mitral valve, the outer frame 1940 can be compressed in such a way that the region below the valve annulus 40 is further radially inward than the region above the valve annulus 40. This allows the outer frame 1940 to exert force on the natural leaflet and / or the natural mitral valve annulus 40 in a direction at least toward the ventricle. This force can generate a reaction force that can tend to push the outer frame 1940 and the prosthesis 1900 toward the atrium. In embodiments where the inner frame anchoring structure 1924 contacts the valve annulus, this can increase the force exerted by the inner frame anchoring structure 1924 on the valve annulus. Furthermore, this reaction force can reduce the likelihood of the prosthesis 1900 moving toward the left ventricle during phases of the cardiac cycle.

[0305] The shape of the example outer frame body 1942 facilitates the positioning of the inner frame anchoring structure 1924 during partial deployment of the prosthesis 1900. During this deployment phase, the inner frame anchoring structure 1924 can be released while the upper end of the outer frame body 1942 remains within the delivery system. Because the larger diameter portion of the outer frame body 1942 is close to the upper region 1942a and the lower region 1942c is attached to the inner frame 1920, the outer frame body 1942 can be substantially constrained without expansion. In this way, the outer frame body 1942 can maintain a smaller profile during partial deployment. The smaller profile of the outer frame body 1942 increases the gap between the inner frame anchoring structure 1924 and the outer frame body 1942 during partial deployment, which facilitates the placement of the inner frame anchoring structure 1924 at the target tissue location and / or the capture of the natural valve tissue between the inner frame anchoring structure 1924 and the outer frame body 1942.

[0306] Continue to refer to Figure 38AThe illustrated prosthesis 1900 has a valve body 1960 attached to the inner frame 1920 within the inner frame body 1922. The valve body 1960 functions as a one-way valve, allowing blood flow through the valve body 1960 in a first direction and inhibiting blood flow through the valve body 1960 in a second direction. As shown in the example embodiment, the valve body 1960 may include a plurality of leaflets 1962 and / or liners 1964. Liners 1964 may be positioned between at least the upper edge of the leaflets 1962 and the inflow end of the inner frame 1960. In some cases, the leaflets 1962 may be attached to the liner 1964, which in turn is attached to the inner frame 1960.

[0307] Next reference Figure 38A The skirts 1980 and 1990 shown are described below. The outer skirt 1980 may be attached to the inner frame 1920 and / or the outer frame 1940. As shown, the outer skirt 1980 may be positioned around and secured to a portion or all of the outer frame 1940. As shown, the outer skirt 1980 may follow the contour of the outer frame 1940; however, it should be understood that at least a portion of the skirt 1980 may be spaced apart from at least a portion of the inner frame 1920 and the outer frame 1940. The inner skirt 1990 may be attached to the valve body 1960 and the outer skirt 1980. As shown, a first end of the inner skirt 1990 may be coupled to the valve body 1960 along a portion of the valve body 1960 near the inner frame 1920. A second end of the inner skirt 1990 may be attached to a lower region of the outer skirt 1980. Although described as separate structures, it should be understood that the outer skirt 1980 and the inner skirt 1990 can be formed integrally. Furthermore, it should be understood that the lining 1964 and the inner skirt 1990 can be formed integrally.

[0308] The outer skirt 1980 may extend to a location below the junction between the inner frame body 1922 and the inner frame anchoring structure 1924. This advantageously provides a larger surface area for the outer skirt 1980 to form a seal with the tissue of a natural valve, such as a natural mitral valve. Furthermore, the inward taper of the outer skirt 1980 allows for better conformity to natural anatomical structures, such as natural mitral valve leaflets, when partially positioned between the inner frame anchoring structure 1924 and the outer frame 1940. This further enhances the seal along the outer skirt 1980.

[0309] Although the outer skirt 1980 is shown extending outwards along the outer frame body 1942, it should be understood that the outer skirt 1980 may extend inwards along the outer frame body 1942. This allows the outer frame body 1942 to directly contact the tissues of the body cavity. In embodiments where the outer frame body 1942 includes struts and / or units, tissues may extend between the struts and / or units. This can advantageously enhance the fixation of the prosthesis 1900 to the body cavity.

[0310] As shown in the example embodiment, cavity 1992 can be formed between the outer skirt 1980 and the inner skirt 1990, opening upwards. With the prosthesis 1900 positioned within the natural mitral valve, cavity 1992 can open towards the atrium. Therefore, during systole, the pressure at cavity 1992 can be lower than that at the ventricle. This can advantageously enhance the sealing of the outer skirt 1980, as natural tissue (such as natural mitral valve leaflets) is driven towards the outer skirt 1980 due to the pressure gradient between the ventricle and cavity 1992.

[0311] In some embodiments, cavity 1992 may be filled with a material, such as, but not limited to, silicone, saline solution, foam, hydrogel, knitted polyester such as polyethylene terephthalate (PET) and / or polyvalve lactone (PVL), other materials, and / or combinations of such materials. The filling material may be included in cavity 1992 prior to deployment of prosthesis 1900. In some embodiments, the filling material may be added after at least partial deployment of prosthesis 1900. For example, the filling material may be pre-formed into a cylindrical or ring shape and then positioned within cavity 1992 after prosthesis 1900 has been deployed.

[0312] Filler material can be used to fill cavity 1992 to reduce opening volume. In some embodiments, the filler material can promote tissue growth within the cavity. In some embodiments, the filler material can promote healing of tissue surrounding prosthesis 1900. In some embodiments, the filler material can advantageously modify the structural characteristics of outer frame 1940 and / or inner frame 1920. For example, the filler material can be used to reduce the compliance of outer frame 1940 along certain portions of the outer frame and / or to transfer forces applied to outer frame 1940 to inner frame 1920. This can advantageously allow outer frame 2040 to apply greater forces along these areas.

[0313] In some embodiments, cavity 1992 may include a cover (not shown) to partially or completely enclose cavity 1992. The upper end of the outer skirt 1980 may be attached to the upper end of the inner skirt 1990 and / or the lining 1964, such that the cover extends generally perpendicular to the longitudinal axis. However, it should be understood that the cover may take other shapes. In some embodiments, the cover may extend downward and radially inward to allow blood to converge toward the inflow end of the inner frame 1920. In some embodiments, the cover may extend upward and radially inward. This can create a tapering shape, facilitating recapture by the device.

[0314] In some embodiments, the covering may be at least partially permeable to allow blood flow into cavity 1992, and / or sufficiently impermeable to inhibit larger particles such as clots. For example, the covering may be formed of a mesh, woven material, and / or perforated material, such as cloth or silk mesh. This can promote tissue growth within cavity 1992 and / or on the covering. For example, the covering may allow endothelialization. This tissue growth can be enhanced in conjunction with the aforementioned filling material. In some embodiments, the covering may be formed of a substantially impermeable material to inhibit fluid flow into cavity 1992. In some embodiments, this material may be the same material forming skirt 2080 and / or inner skirt 1990.

[0315] Although the prosthesis 1900 has been described as including an inner frame 1920, an outer frame 1940, a valve body 1960, and skirts 1980 and 1990, it should be understood that the prosthesis 1900 does not need to include all components. For example, in some embodiments, the prosthesis 1900 may include the inner frame 1920, the outer frame 1940, the valve body 1960, and the outer skirt 1980, while omitting the inner skirt 1990, particularly when a covering is used. Furthermore, although the components of the prosthesis 1900 have been described and exemplified as separate components, it should be understood that one or more components of the prosthesis 1900 may be formed integrally or monolithically. For example, in some embodiments, the inner frame 1920 and the outer frame 1940 may be formed integrally or monolithically as a single component.

[0316] Next reference Figures 39-42 This document illustrates an embodiment of a prosthesis 2000 in an expanded configuration, or components of the prosthesis 2000. The prosthesis 2000 may include an inner frame 2020, an outer frame 2040, a valve body 2060, and a skirt 2080. The prosthesis 1900 may share features that are identical or at least similar to those of other prostheses described herein (such as prosthesis 1900), such as structural and / or functional features.

[0317] First refer to Figures 39-41 The outer frame 2040 shown may include an outer frame body 2042. The outer frame body 2042 may have an upper region 2042a, a middle region 2042b, and a lower region 2042c. As shown, when in an expanded configuration such as a fully expanded configuration, the outer frame body 2042 may have an enlarged shape, wherein the upper region 2042a and the middle region 2042b are larger than the lower region 2042c. The enlarged shape of the outer frame body 2040 may advantageously allow the outer frame body to engage with the natural valve annulus, natural valve leaflet, or other body cavity, while separating the inlet and outlet from the heart or blood vessel wall.

[0318] The lower region 2042c of the outer frame body 2042 may extend radially outward and / or upward toward the upper region away from the longitudinal axis of the prosthesis 2000. As shown in the example embodiment, the lower region 2042c may include a bend or curve such that the angle of the lower region 2042c relative to the longitudinal axis decreases toward the upper end of the lower region 2042c. However, it should be understood that in some embodiments, the lower region 2042c may extend substantially linearly.

[0319] The middle region 2042b of the outer frame body 2042 can generally extend upward from the lower region 2042c. As shown, the middle region 2042b can have a generally constant diameter from the lower end to the upper end, such that the middle region 2042b forms a generally cylindrical shape. The upper region 2042a of the outer frame body 2042 can generally extend upward from the upper end of the middle region 2042b. As shown, the upper region 2042a of the outer frame body 2042 can have a generally constant diameter from the lower end to the upper end, such that the upper region 2042a forms a generally cylindrical shape. However, it should be understood that the diameters of the upper end, lower end, and / or portions in between of the middle region 2042b and / or the upper region 2042a can be different. For example, in some embodiments, the diameter of the portion between the upper and lower ends may be larger than the diameters of the upper and lower ends, such that the intermediate region 2042b and / or the upper region 2042a form an overall bulbous shape (as shown, for example, in combination). Figure 7-8 (See frame 300 shown). 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.

[0320] Furthermore, although the outer frame body 2042 has been described and exemplified as cylindrical or having a circular cross-section, it should be understood that all or part of the outer frame body 2042 may have a non-circular cross-section, such as, but not limited to, D-shaped, oval, or other oval cross-sectional shapes.

[0321] Continue to refer to Figures 39-41 The outer frame 2040 shown, and the outer frame body 2042 may include a plurality of pillars, wherein at least some of the pillars form units 2044a-d. Any number of pillar configurations may be used, such as the rings showing undulating pillars forming elliptical, oval, rounded polygonal and teardrop shapes, as well as V-shaped, rhomboid, curved and various other shapes.

[0322] As shown in the example embodiments, units 2044a-d may have a rhomboid or generally rhomboid shape. Units 2044a-d can be considered as substantially shortened portions of the outer frame 2040. Although the supports forming units 2044a-d are generally exemplified as straight segments, it should be understood that some or all of the supports may not form completely straight segments. For example, the supports may include a degree of curvature such that the upper vertex and / or lower vertex are curved.

[0323] As shown in the example implementation, there can be three rows of eighteen cells 2044a-c and one row of nine cells 2044d. Although each cell 2044a-d is shown to have the same shape as the other cells 2044a-d in the same row, it should be understood that the shapes of cells 2044a-d within a row can be different. Moreover, it should be understood that any number of rows of cells can be used, and any number of cells can be contained in a row.

[0324] Next reference Figure 42 An example is provided for the inner frame 2020 of the prosthesis 2000. The inner frame 2020 may include an inner frame body 2022 and an inner frame anchoring structure 2024. As shown, the inner frame body 2022 may have an upper region 2022a, a middle region 2022b, and a lower region 2022c. As shown, the inner frame body 2022 may have a generally cylindrical shape such that the diameters of the upper region 2022a, the middle region 2022b, and the lower region 2022c are generally equal. However, it should be understood that the diameters of the upper region 2022a, the middle region 2022b, and / or the lower region 2022c may be different. For example, in some embodiments, the diameter of the lower region 2022c may be larger than the diameter of the upper region 2022a. In other embodiments, the diameter of the upper region 2022a may be larger than the diameter of the lower region 2022c.

[0325] The diameters of the upper region 2022a, the middle region 2022b, and / or the lower region 2022c of the inner frame body 2022 can be selected such that the inner frame body 2022 is sufficiently spaced from the body cavity when the prosthesis 2000 is positioned within the body cavity. For example, in an embodiment where the prosthesis 2000 is positioned within the natural mitral valve, the diameter of the inner frame body 2022 may be smaller than the diameter of the natural mitral valve annulus. Although the inner frame body 2022 has been described and exemplified as cylindrical or having a circular cross-section, it should be understood that all or part of the inner frame body 2022 may have a non-circular cross-section, such as, but not limited to, D-shaped, oval, or other oval cross-sectional shapes.

[0326] The inner frame body 2022 may be substantially non-shortened. This advantageously allows the inner frame body 2022 to maintain its axial length when transitioning from a crimped configuration to an expanded configuration. This reduces the folded length of the inner frame body 2022, which facilitates positioning within a delivery system. As shown in the example embodiment, the inner frame body 2022 may include longitudinally extending struts 2026. The longitudinally extending struts 2026 may extend in a direction generally parallel to the longitudinal axis of the prosthesis 2000. The longitudinally extending struts 2026 may extend from the upper region 2022a of the inner frame body 2022 to the lower region 2022c of the inner frame body 2022. Although the longitudinally extending struts 2026 extend in a direction generally parallel to the longitudinal axis of the prosthesis 2000, it should be understood that at least a portion of these struts 2026 may extend in a direction transverse to the longitudinal axis.

[0327] As shown in the example implementation, the inner frame body 2022 may include nine longitudinally extending struts 2026. It should be understood that fewer or more struts may be used. The number of struts may be a multiple of the number of valve bodies fused together. For example, in the case of using a valve body with three fused together, the inner frame body 2022 may include three, six, twelve, fifteen or more struts.

[0328] Multiple undulating struts may extend between the longitudinally extending struts 2026. In some embodiments, the inner frame body 2022 may include one or more sets of struts extending circumferentially around the inner frame body 2022. As shown, the inner frame body 2022 may include a first set, a second set, and a third set of struts 2028a-c extending circumferentially around the inner frame body 2022. Each set of struts 2028a-c may have a zigzag or undulating shape forming repeating “V” shapes. The ends of these “V” shapes may form “U” shapes. This can facilitate the transition of the inner frame body 2022 between a wrinkled configuration and an expanded configuration.

[0329] As shown, the first and second sets of supports 2028a-b can extend in a direction generally parallel to the longitudinal axis of the prosthesis 2000. Thus, the first and second sets of supports 2028a-b can form a generally cylindrical shape. The third set of supports 2028c can extend radially inward toward the longitudinal axis of the prosthesis 2000. This radially inward shape can correspond to the shape of the lower region 2042c of the outer frame body 2042. This can advantageously facilitate the attachment of the outer frame body 2042 to the inner frame body 2022 along the lower regions 2022c, 2042c.

[0330] The inner frame 2020 may include one or more eyelets to facilitate the attachment of one or more components of the prosthesis 2000 to the inner frame 2020. As shown in the example embodiment, the inner frame 2020 may include an upper group and / or a lower group of eyelets 2030a-b. The upper group of eyelets 2030a may be positioned along the upper region 2022a of the inner frame body 2022. As shown, the eyelet 2030a may be positioned at or near the upper end of the longitudinally extending strut 2026.

[0331] Eyelet 2030a can be used to attach the inner frame 2020 to a delivery device, such as a suture- or tether-based delivery device. For example, a suture or tether can be attached to eyelet 2030a. In some embodiments, the outer frame 2040 may include an upper set of eyelets (not shown) in place of or in combination with the upper eyelet 2030a. In embodiments where both the inner frame 2020 and the outer frame 2040 have eyelets, a tether or suture can pass through the corresponding eyelets of the inner frame 2020 and the outer frame 2040. When tightened, the tether or suture can pull the inner frame 2020 and the outer frame 2040 closer together. This can facilitate the re-capture of the prosthesis 2000.

[0332] The lower group of eyelets 2030b can be positioned along the lower region 2022c of the inner frame body 2022. As shown in the example embodiment, the lower group of eyelets 2030b can be positioned along the descending support 2028c. Eyelets 2030b can be used to facilitate the attachment of the outer frame 2040 to the inner frame 2020. For example, in some embodiments, the outer frame 2040 may include one or more eyelets corresponding to eyelets 2030b. The inner frame 2020 and the outer frame 2040 can be attached together through eyelets 2030b and corresponding eyelets on the outer frame 2040. For example, the inner frame 2020 and the outer frame 2040 can be sewn together through said eyelets, or attached by other means, such as mechanical fasteners (e.g., screws, rivets, etc.).

[0333] Although a single eyelet 2030b is shown extending from each "V"-shaped support, it should be understood that some "V"-shaped supports may not include eyelets. Furthermore, it should be understood that multiple eyelets may extend from a "V"-shaped support. For example, two eyelets may extend in series. This can enhance the stability of the coupling between the inner frame 2020 and the outer frame 2040 by allowing stitches to pass through two adjacent eyelets. For example, this can reduce the likelihood of the outer frame 2040 twisting along the eyelet axis.

[0334] Continue to refer to Figure 42The inner frame 2020 shown may have an inner frame anchoring structure 2024 extending at or near the lower end of the lower region 2022c of the inner frame body 2022. The inner frame anchoring structure 2024 may be formed by a plurality of individual anchors 2024a extending from the frame body 2022. Anchors 2024a may extend downward from one or more attachment points to the inner frame body 2022, including but not limited to longitudinally extending struts 2026. As shown, anchors 2024a may be extensions of the longitudinally extending struts 2026. This can advantageously enhance the structural integrity of the anchors 2024a. Anchors 2024a may be bent to extend radially outward in general along the longitudinal axis of the prosthesis 2000. Although anchors 2024a are shown extending from the longitudinally extending struts 2026, it should be understood that anchors 2024a may be attached to the inner frame body 2022 frame at one of a variety of different locations (including apexes, joints, other portions of struts, etc.).

[0335] Anchor 2024a may extend upward toward end or tip 2024b. End or tip 2024b may be positioned radially outward relative to the longitudinal axis of prosthesis 2000. As shown, end or tip 2024b may extend upward in a direction generally parallel to the longitudinal axis of prosthesis 2000; however, it should be understood that end or tip 2024b may have other geometries as described herein. For example, end or tip may extend generally perpendicular to the longitudinal axis of prosthesis 2000. Although anchor 2024a is shown as having a single bend, it should be understood that one or more anchors may include first, second, third, or more spaced-apart bends along the length of each anchor. Further details that may be incorporated and / or interchanged with the features described herein are disclosed in U.S. Publications 2014 / 0277422, 2014 / 0277427, 2014 / 0277390 and 2015 / 0328000, and U.S. Application No. 15 / 653,390 entitled REPLACEMENT HEART VALVE PROTHESIS, filed July 18, 2017, which are incorporated herein by reference.

[0336] As shown in the example implementation, the inner frame anchoring structure 2024 may include nine individual anchors; however, 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 ligatures in the valve body 2060. Thus, for a prosthesis 2000 with three ligatures in the valve body 2060, the inner frame anchoring structure 2024 may have 3 individual anchors (1:1 ratio), 6 individual anchors (2:1 ratio), 9 individual anchors (3:1 ratio), 12 individual anchors (4:1 ratio), 15 individual anchors (5:1 ratio), or any other multiple of three. It should be understood that the number of individual anchors does not need to correspond to the number of ligatures in the valve body 2060.

[0337] Return to reference Figures 39-41 The inner frame anchoring structure 2024 may include a cover and / or padding 2032 to surround or partially surround at least a portion of the inner frame anchoring structure 2024, such as an end or tip 2024b. The cover and / or padding 2032 may be similar to those described in padding 238 and / or U.S. Publication No. 2015 / 0328000, the entire contents of which are incorporated herein by reference. As shown in the example embodiment, the cover and / or padding 2032 is attached to all anchors 2024a; however, it should be understood that the cover and / or padding 2032 may be used on subgroups of anchors 2024a.

[0338] As shown in the example embodiment, the radial extent of the tip or end 2024b of the inner frame anchoring structure 2024 can be greater than the radial extent of the outer frame body 2042 at the plane of the tip or end 2024b. The tip or end 2024b can be positioned such that it is spaced apart from the exterior of the outer frame body 2042. This can provide a gap that can hold the body cavity tissue. For example, in the case where the prosthesis 2000 is positioned within a natural mitral valve, the natural mitral valve leaflets can be positioned between these gaps. It should be understood that the gap between the tip or end 2024b and the outer frame body 2042 can be reduced. For example, in some embodiments, the tip or end 2024b can be positioned close to or in contact with the exterior of the outer frame body 2042. This can advantageously increase the force applied by the prosthesis 2000 to clamp or hold the body cavity tissue therebetween.

[0339] Continue to refer to Figures 39-41The valve body 2060 may share features that are identical or at least similar to those of other valve bodies described herein, such as structural and / or functional features. The valve body 2060 may include one or more leaflets 2062 and / or a liner 2064. The liner 2064 may be used to assist fluid flow through and / or around the prosthesis 2000, such as through the inner frame 2020 and the valve leaflets 2062, and around the inner frame 2020 and the valve leaflets 2062. The liner 2062 may surround at least a portion of the valve leaflets 2062 and be attached to one or more of the valve leaflets 2062. For example, as shown in the example embodiment, the one or more valve leaflets 2062 may be attached to the liner 2064 along the upper edge of the valve leaflet 2062.

[0340] As shown in the example embodiment, the liner 2064 may be positioned within the inner frame 2020 and may form the inner wall of the prosthesis 2000. It is also contemplated that the liner 2064 may be positioned at least partially outside the inner frame 2020 and / or the outer frame 2040, such that at least a portion of the liner 2064 extends radially outward from the struts of the inner frame 2020 and / or the outer frame 2040 relative to the longitudinal axis of the prosthesis 2000. As shown in the example embodiment, the liner 2064 may be positioned along the upper side or the inlet side of the inner frame 2020. The liner 2064 may extend above the upper edge of the leaflet 2062 toward the upper end of the inner frame 2020. As shown, the liner 2064 may also extend below the upper edge of the leaflet 2062 toward the lower end of the inner frame 2020.

[0341] Continue to refer to Figures 39-41 The skirt 2080 may share features identical or at least similar to those of other skirts described herein, such as structural and / or functional features. The skirt 2080 may be positioned around and secured to at least a portion of the exterior of the prosthesis 2000 (e.g., but not limited to the inner frame 2020 and / or outer frame 2040). The skirt 2080 may be annular and may extend circumferentially around the entire prosthesis 2000. The skirt 2080 may prevent or inhibit backflow of fluid around the prosthesis 2000. For example, when the skirt 2080 is annularly positioned around the exterior of the prosthesis 2000, the skirt 2080 may establish an axial barrier to fluid flow outside the prosthesis 2000 when deployed within a body cavity. As shown, the skirt 2080 may seal against at least a portion of the tissue surrounding the body cavity. Additionally, the skirt 2080 may promote inward tissue growth between the flap assembly 2080 and the natural tissue of the body cavity. This may further help prevent blood leakage around the prosthesis 2000.

[0342] As shown in the example embodiment, the skirt 2080 may extend along the exterior of the outer frame body 2042. This can increase the contact area between the body cavity tissue and the skirt 2080. This can advantageously enhance the seal around the prosthesis 2000 by providing a smooth, continuous contact along the periphery of the outer frame 2040 and the skirt 2080. In embodiments where the skirt 2080 is formed of a material that promotes inward tissue growth, this increased contact area can be beneficial.

[0343] Although the skirt 2080 is shown extending outward along the outer frame body 2042, it should be understood that part or all of the skirt 2080 may extend inward along the outer frame. This allows body cavity tissues to contact and / or extend between the struts forming the outer frame body 2042. For example, body cavity tissues may contact and / or extend between the struts forming one or more units 2044a-d. This can advantageously enhance the stability and / or fixation of the prosthesis 2000 to the body cavity tissues. It should also be understood that although the skirt 2080 is shown tautly attached to the outer frame 2040, part or all of the skirt 2080 may be loosely attached, allowing part or all of the skirt 2080 to move relative to the outer frame 2040.

[0344] The upper end of the skirt 2080 may be positioned at or near the upper end of the outer frame body 2042 and / or the upper end of the inner frame body 2022. The lower end of the skirt 2080 may be positioned at or near the lower end of the outer frame body 2042. The skirt 2080 may be attached to the outer frame 2040 and / or the inner frame 2020 using any of the fasteners and / or techniques described herein. For example, portions of skirt 2080 may be attached to the struts and / or anchoring structures of outer frame 2040 and / or inner frame 2020 using any of the fasteners and / or techniques described herein, including but not limited to mechanical fasteners such as stitches, U-bolts, screws, rivets, connecting components (e.g., joints and slots), and any other desired type of mechanical fastener; chemical fasteners such as adhesives and any other desired type of chemical fastener; fastening techniques such as fusion welding, brazing, sintering, and any other desired type of fastening technique; and / or combinations of such fasteners and techniques.

[0345] Return to reference Figure 42The inner frame 2020 shown may include a set of locking connectors 2034 extending at or near the upper end of the upper region 2022a of the inner frame body 2022. As shown, the locking connectors 2034 may extend at or near the upper end of the longitudinal struts 2030 and / or the upper set of eyelets 2030a. The locking connectors 2034 may extend upward in a direction generally aligned with the longitudinal axis of the prosthesis 2000. As shown in the example embodiment, the locking connectors 2034 may include longitudinally extending struts 2034a. At the upper end of the struts 2034a, the locking connectors 2034 may include an enlarged head 2034b. As shown, the enlarged head 2034b may have a semi-circular or semi-elliptical shape, forming a “mushroom” shape together with the struts 2034a. As shown, the inner frame 2020 may include nine locking connectors 2034; however, it should be understood that more or fewer locking connectors may be used. Furthermore, it should be understood that part or all of the locking connector 2034 may be omitted.

[0346] The locking connector 2034 can be advantageously used with a variety of delivery systems. For example, the shape of the locking connector 2034 can allow the prosthesis 2000 to be used with a variety of delivery systems, such as, but not limited to, slot-based delivery systems and tether-based delivery systems, such as those that use sutures, threads, or fingers to control delivery. In some embodiments, the prosthesis 2000 can be used with the delivery systems described herein, including, but not limited to, those described in U.S. Patent Nos. 8,414,644 and 8,652,203 and U.S. Publication No. 2015 / 0238315, the entire contents of which are incorporated herein by reference and are a part of this specification.

[0347] Although the locking connector 2034 is shown extending from the inner frame 2020, it should be understood that the locking connector may extend from the outer frame 2040, in place of or additionally to the locking connector 2034. Furthermore, although the locking connector is shown extending generally parallel to the longitudinal axis, it should be understood that locking connectors such as locking connector 2034 or those on the outer frame may extend at an angle relative to the longitudinal axis. This can advantageously allow the locking connector to act as an upper anchoring element (similar to a coupling). Figure 38A The upper anchorage discussed in 1944).

[0348] Next reference Figure 43 An embodiment of an outer frame 2100 in an expanded configuration is illustrated. The outer frame 2100 may include an outer frame body 2102 and / or an outer frame anchoring structure 2104. The outer frame 2100 may share features that are identical or at least similar to those of other outer frames described herein (such as outer frames 1940 and 2040 described above in conjunction with Figures 38 and 39-41), such as structural and / or functional features.

[0349] When in an expanded configuration (such as a fully expanded configuration), the outer frame body 2102 may have a shape similar to outer frames 1940 and 2040. As shown, the diameters of the upper region 2102a and the middle region 2102b may be larger than the diameter of the lower region 2102c. The lower region 2102c of the outer frame body 2102 may have a diameter that decreases from the upper end to the lower end of the lower region 2102c, such that the lower region 2102c is radially inwardly inclined or bent toward the longitudinal axis of the outer frame 2100. This radially inwardly inclined or bent lower region 2102c can facilitate the capture of the natural valve leaflet between the outer frame 2100 and other parts of the prosthesis using the outer frame 2100 (such as anchoring structures). Furthermore, this radially inwardly inclined or bent lower region 2102c can reduce or suppress potential trauma to body cavity tissues such as the natural leaflet and / or the natural valve annulus. For example, the curvature and / or tilt of the lower region 2102c can be selected to better conform to the curvature of the tissue positioned between the outer frame 2100 and the anchoring structure of another part of the prosthesis using the outer frame 2100.

[0350] Although the outer frame body 2102 has been exemplified as having a circular cross section, it should be understood that all or part of the outer frame body 2102 may have a non-circular cross section, such as, but not limited to, D-shaped, oval or other oval cross section shapes.

[0351] Continue to refer to Figure 43 The outer frame 2100 shown, the outer frame body 2102 may include a plurality of pillars, wherein at least some of the pillars form units 2106a-c. Any number of pillar configurations may be used, such as the rings showing undulating pillars forming elliptical, oval, rounded polygonal and teardrop shapes, as well as V-shaped, rhomboid, curved and various other shapes.

[0352] The ascending unit 2106a may have an irregular octagonal shape, such as a heart shape. This larger shape can provide additional space for the outer frame anchoring structure 2104. This additional space can advantageously allow the outer frame 2100 to maintain a smaller profile when folded. The unit 2106a may be formed by a combination of struts. As shown in the example embodiment, the upper part of the unit 2106a may be formed by a set of circumferentially expandable struts 2108a, which have a Z-shaped or undulating shape forming a repeating "V" shape.

[0353] The middle portion of unit 2106a may be formed by a set of struts 2108b, which extend downward from the bottom end of each "V" shape. The struts 2108b may extend along a plane parallel to and / or extending through the longitudinal axis of the prosthesis 2100. The portion of unit 2106a extending upward from the bottom end of the struts 2108b can be considered as the essentially non-shortened portion of the outer frame 2100.

[0354] The lower portion of unit 2106a may be formed by a set of circumferentially expandable struts 2108c, each strut having a zigzag or undulating shape forming a repeating “V” shape. One or more upper ends or upper tips of the circumferentially expandable struts 2108c may be “free” vertices not connected to the struts. For example, as shown in the example embodiment, every other upper end or upper tip of the circumferentially expandable strut 2108b is a free vertice. However, it should be understood that other configurations may be used. For example, each upper vertex along the upper end may be connected to a strut.

[0355] The middle and / or lower rows of cells 2106b-c may have a different shape than the first row of cells 2106a. The middle row of cells 2106b and the lower rows of cells 2106c may have a rhomboid or generally rhomboid shape. The rhomboid or generally rhomboid shape may be formed by combining the pillars.

[0356] The upper portion of unit 2106b may be formed by the set of circumferentially expandable struts 2108c, such that unit 2106b shares struts with unit 2106a. The lower portion of unit 2106b may be formed by a set of circumferentially expandable struts 2108d. As shown in the example embodiment, one or more circumferentially expandable struts 2108d may generally extend in a downward direction and radially inward toward the longitudinal axis of the outer frame 2100. For example, the one or more circumferentially expandable struts 2108d may be curved, such that the upper portion of the strut 2108d is positioned further away from the longitudinal axis of the outer frame 2100 than the lower portion of the strut 2108d.

[0357] The upper portion of unit 2106c may be formed by the set of circumferentially expandable struts 2108d, such that unit 2106c shares struts with unit 2106b. The lower portion of unit 2106c may be formed by a set of circumferentially expandable struts 2108e. The circumferentially expandable struts 2108e may generally extend in a downward direction. As shown in the example embodiment, the circumferentially expandable struts 2108e may be inclined or bent toward the longitudinal axis of the outer frame 2100, such that the upper portion of the strut 2108e is positioned further away from the longitudinal axis of the outer frame 2100 than the lower portion of the strut 2108e. In some embodiments, the circumferentially expandable struts 2108d may extend in a direction generally parallel to the longitudinal axis of the outer frame 2100.

[0358] As shown in the example implementation, there can be one row of nine units 2106a, one row of eighteen units 2106b, and one row of nine units 2106c. Although each unit 2106a-c is shown to have the same shape as the other units 2106a-c in the same row, it should be understood that the shapes of the units 2106a-c within a row can be different. Moreover, it should be understood that any number of rows of units can be used, and any number of units can be contained in a row.

[0359] Continue to refer to Figure 43 The outer frame 2100 may include an outer frame anchoring structure 2104. The outer frame anchoring structure 2104 may include one or more individual anchor elements 2104a having a tip or end 2104b. As shown, the outer frame anchoring structure 2104 includes three anchor elements; however, it should be understood that fewer or more anchor elements may be used. For example, the outer frame anchoring structure 2104 may include nine anchor elements 2104a.

[0360] As shown, anchor 2104a extends from the upper part of unit 2106a (such as the upper apex of unit 2106a). Anchor 2104a may extend downward. Anchor 2104a may be attached to the outer frame body 2102 such that when changing from a wrinkled configuration to an expanded configuration, the tip or end 2104b of anchor 2104a moves radially outward and upward.

[0361] In some embodiments, one or more anchors 2104a may be attached to the outer frame body 2102 along the strut 2108c. For example, the anchors 2104a may extend from one or more free apexes. The anchors 2104a may be attached to the outer frame body 2102 such that, when transitioning from a wrinkled configuration to an expanded configuration, the tips or ends 2104b of the anchors 2104a move radially outward and downward. This can advantageously facilitate the alignment of the prosthesis 2104a. Moreover, it should be understood that the anchors 2104a and / or tips or ends 2104b may be barbs or penetrating structures. The barbs may be angled upward, angled downward, and / or vertical. Although shown extending along the upper region of the outer frame body 2102, it should be understood that such barbs or other penetrating structures may extend along other regions of the outer frame body 2102.

[0362] As shown in the example embodiment, the outer frame 2100 may include an upper group of eyelets 2110a and / or a lower group of eyelets 2110b. The upper group of eyelets 2110a may extend from the upper region 2102a of the outer frame body 2102. As shown, the upper group of eyelets 2110a may extend from the upper part of unit 2106a (such as the upper vertex of unit 2106a). The upper group of eyelets 2110a can be used to attach the outer frame 2100 to a delivery system. For example, stitching or tethers of the delivery system may be attached to or pass through the upper group of eyelets 2110a.

[0363] The lower group of eyelets 2110b can be positioned along the lower region 2102c of the outer frame body 2102. As shown, the lower group of eyelets 2110b can extend from the upper part of unit 2106c (such as the lower apex of unit 2106c). The lower group of eyelets 2110b can be used to attach the outer frame 2100 to the inner frame of the prosthesis. For example, in some embodiments, the inner frame may include one or more eyelets corresponding to the eyelets 2110b. The inner frame and outer frame 2100 can be attached together through these eyelets. For example, the inner frame and outer frame 2040 can be sewn together through the eyelets or attached by other means, such as mechanical fasteners (e.g., screws, rivets, etc.).

[0364] As shown, the lower set of eyelets 2110b may include two eyelets extending in series from each “V”-shaped strut. This reduces the possibility of the outer frame 2040 twisting along the eyelet axis. However, it should be understood that some “V”-shaped struts may not include eyelets. Moreover, it should be understood that fewer or more eyelets may extend from the “V”-shaped struts.

[0365] Next reference Figure 44 This document illustrates an embodiment of a prosthesis 2200 in an expanded configuration, or components of the prosthesis 2200. The prosthesis 2200 may include an inner frame 2220, an outer frame 2240, a valve body 2260, and a skirt 2280. The prosthesis 2200 may share features that are identical or at least similar to those of the prostheses described herein (such as prostheses 1900 and 2000), such as structural and / or functional features.

[0366] The prosthesis 2200 may include a cover 2290 to close the gap between the inner frame 2220 and the upper region of the outer frame 2240. The cover 2290 may extend between the upper end of the outer skirt 2280 and the upper ends of the leaflets 2262 and / or lining 2264 of the valve body 2260. As shown, the cover 2290 extends generally perpendicular to the longitudinal axis; however, it should be understood that the cover 2290 may extend transversely to the longitudinal axis. In some embodiments, the cover 2290 may extend downward and radially inward toward the inflow end of the inner frame 2220 and toward the leaflets to collect blood. In some embodiments, the cover 2290 may extend upward and radially inward. This can form a tapering shape, which can facilitate re-capture of the device. As shown, the cover 2290 may be integrally formed with the skirt 2280; however, it should be understood that the cover 2290 may be formed separately from the skirt 2280.

[0367] The prosthesis 2200 may include a pad 2224 extending along the length of the inner frame anchoring structure 2222. The pad 2224 may include a first portion 2224a extending along a portion of the individual anchor and a second portion 2224b extending along the tip or end of the individual anchor. The pad 2224 may advantageously reduce trauma to the body cavity tissues.

[0368] Next reference Figure 45 This document illustrates an embodiment of a prosthesis 2300 in an expanded configuration, or components of the prosthesis 2300. The prosthesis 2300 may include an inner frame 2320, an outer frame 2340, a valve body 2360, and a skirt 2380. The prosthesis 2300 may share features that are identical or at least similar to those of the prostheses described herein, such as structural and / or functional features.

[0369] The prosthesis 2300 may include a suture 2390 extending between the inner frame 2320 and the outer frame 2340. In some embodiments, the suture 2390 may extend between the lower portion of the outer frame 2340 and the lower portion of the inner frame body 2322 and / or the inner frame anchoring structure 2324. The suture 2390 may be tensioned such that a radially inward force is applied to the outer frame 2340 and a radially outward force is applied to the inner frame 2320. This advantageously enhances the structural integrity of the prosthesis 2300 by maintaining the initial strain of the outer frame 2340 and the inner frame 2320. In embodiments utilizing a material having a generally linear elastic modulus, the pre-strained frame components may require greater force to further strain the frame components.

[0370] Furthermore, by binding the movement of the outer frame 2340 and the inner frame 2320 together, the structural integrity of the prosthesis 2300 can be enhanced. For example, the application of a downward-oriented force to the anchoring structure 2342 may tend to cause the inner frame anchoring structure 2342 to move in a downward and / or radially inward direction. By binding the outer frame 2340 and the inner frame 2320 together, the inner frame 2320 can pull the outer frame 2340 in the same direction. Thus, the force required to move the inner frame anchoring structure 2342 will be higher than the force required to move the inner frame anchoring structure 2342 independently of the outer frame 2340.

[0371] Next reference Figures 46-47 An embodiment of a prosthesis 2400 in an expanded configuration is illustrated. The prosthesis 2400 may include an inner frame 2420, an outer frame 2440, a valve body 2460, and one or more skirts, such as an outer skirt 2480 and an inner skirt 2490. The prosthesis 2400 may share features that are identical or at least similar to those of other prostheses described herein (such as prostheses 1900, 2000, and 2200), such as structural and / or functional features.

[0372] Referring first to the inner frame 2420, the inner frame 2420 may include an inner frame body 2422 and an inner frame anchoring structure 2424. As shown, the inner frame body 2422 may have a generally bulbous shape and / or a truncated conical shape. The diameter of the upper region 2422a may be smaller than the diameter of the lower region 2422c. This can advantageously allow for the use of a smaller valve body 2460 within the inner frame 2420, while allowing the inner frame body 2422 to have a larger diameter near the connection between the inner frame body 2422 and the inner frame anchoring structure 2424. This larger diameter can reduce the radial distance between the connection and the tip or end of the inner frame anchoring structure 2424. This can advantageously enhance the fatigue resistance of the inner frame anchoring structure 2424 by reducing the length of the cantilever. Moreover, this can allow the inner frame anchoring structure 2424 to more closely match the geometry of the outer frame 2440. The larger diameter can also facilitate valve-in-valve function by providing a larger diameter portion (in which a subsequent replacement valve can be received).

[0373] As shown in the example embodiment, the intermediate region 2422b may have a truncated conical shape, such that its diameter increases linearly from the upper end to the lower end. However, it should be understood that the intermediate region 2422b may include curvature. For example, the intermediate region 2422b may include [missing information - likely related to a specific feature or design]. Figure 33The inner frame body 1522b is described as having a similar geometry. The inner frame body 2422 may include a curved portion 2426 along the lower region 2422c of the inner frame body 2420, such that region 2428 of the inner frame body 2420 tapers radially inward toward the longitudinal axis of the prosthesis 2400. The shape of region 2428 may match the shape of a portion of the outer frame 2440.

[0374] The radially inward curvature enhances the durability of the valve body 2460. For example... Figure 47 As shown, the intermediate component 2464 of the valve body 2460 can couple the connection formed by the leaflets 2464 to the inner frame body 2422. The intermediate component 2464 can extend from below the leaflets 2464. Thus, when the valve body 2460 closes due to upward fluid flow, the intermediate component 2464 is pulled upward and subjected to tension opposite to shear force. This is advantageous when the intermediate component 2464 can withstand more tension than shear force, as it reduces the possibility of tearing of the intermediate component 2464.

[0375] Continue to refer to Figure 46 The prosthesis 2400 shown has a valve body 2460 attached to the inner frame 2420 inside the inner frame body 2422. The valve body 2460 functions as a one-way valve to allow blood flow through the valve body 2460 in a first direction and to inhibit blood flow through the valve body 2460 in a second direction.

[0376] The valve body 2460 may include a plurality of leaflets 2462, such as three leaflets 2462, which are joined at a suture. The valve body 2460 may include one or more intermediate members 2464. The intermediate members 2464 may be positioned between a portion or all of the leaflets 2462 and the inner frame 2420 such that at least a portion of the leaflets 2462 is coupled to the frame 2420 via the intermediate members 2464. In this way, a portion or all of the leaflet 2462 portion at the suture and / or the arcuate edge of the leaflet 2462 is not directly coupled or attached to the inner frame 2420, but is indirectly coupled or "floats" within the inner frame 2420. For example, a portion or all of the leaflet 2462 portion near the suture and / or the arcuate edge of the leaflet 2462 may be radially inwardly spaced from the inner surface of the inner frame 2420. By using one or more intermediate components 2464, the valve leaflet 2462 can be attached to a non-cylindrical frame 2420 and / or a frame 2420 with a diameter larger than that of the valve leaflet 2462. Further details of the floating valve concept can be found in U.S. Patent Application No. 15 / 653,390, filed July 18, 2017, entitled REPLACEMENT HEART VALVEPROSTHESIS, the entire contents of which are incorporated herein by reference.

[0377] Next reference Figure 46 The skirt portions 2480 and 2490 shown are described below. The outer skirt portion 2480 may be attached to the inner frame 2420 and / or the outer frame 2440. As shown, the outer skirt portion 2480 may be positioned around and secured to a portion of the outer frame 2440. As shown, the outer skirt portion 2480 may follow the contour of the outer frame 2440; however, it should be understood that at least a portion of the skirt portion 2480 may be spaced apart from at least a portion of the inner frame 2420 and the outer frame 2440.

[0378] The inner skirt 2490 can be attached to the valve body 2460 and the outer skirt 2480. As shown, a first end of the inner skirt 2490 can be coupled to the valve body 2460 along a portion of the valve body 2460 near the inner frame 2420. A second end of the inner skirt 2490 can be attached to a lower region of the outer skirt 2480. As shown, the inner skirt 2490 can be positioned radially lateral to the inner frame 2420. The inner skirt 2490 can be separated from the inner frame 2490 along a portion between its upper and lower ends, such that the inner skirt 2490. This allows the inner skirt 2490 to form a shape that promotes fluid flow around the lower side of the valve body 2460. This can improve elution on the lower side of the valve, thereby advantageously reducing the risk of thrombus or clot formation below and around the valve body 2460.

[0379] Although the inner skirt 2490 is shown positioned radially outward from the inner frame 2420, it should be understood that the inner skirt 2490 may follow the contour of the inner frame 2420 and / or be positioned along the inner surface of the inner skirt 2490. In some embodiments, the inner frame 2490 may include the shape of the example inner skirt 2490.

[0380] Although the prosthesis 2400 has been described as including an inner frame 2420, an outer frame 2440, a valve body 2460, and skirts 2480 and 2490, it should be understood that the prosthesis 2400 does not need to include all components. For example, in some embodiments, the prosthesis 2400 may include the inner frame 2420, the outer frame 2440, and the valve body 2460, while omitting the skirt 2480. Furthermore, although the components of the prosthesis 2400 have been described and exemplified as separate components, it should be understood that one or more components of the prosthesis 2400 may be formed integrally or monolithically. For example, in some embodiments, the inner frame 2420 and the outer frame 2440 may be formed integrally or monolithically as a single component.

[0381] Next reference Figure 11A-K illustrates an embodiment of a prosthesis 500a-k in an expanded configuration. The prosthesis 500a-k may include an inner frame 520a-k and an outer frame 540a-k. The inner frame 520a-k may share features, such as structural and / or functional features, that are identical or at least similar to those of the inner frames described herein (e.g., inner frames 120, 220, 400). The outer frame 540a-k may share features, such as structural and / or functional features, that are identical or at least similar to those of the outer frames described herein (e.g., outer frames 140, 240, 300).

[0382] First refer to Figure 11A The prosthesis 500a shown may include an outer frame 540a comprising an upper region 542a, a middle region 544a, and a lower region 546a. The upper region 542a may include a longitudinally extending portion 548a and an outwardly extending portion 550a. The middle region 544a may extend from the outwardly extending portion 550a. As shown in the example embodiment, the middle region 544a may extend in a direction generally parallel to the longitudinal axis of the prosthesis 500a. The lower region 546a may extend from the middle region 544a. The lower region 546a may bend to extend radially inward toward the longitudinal axis of the prosthesis 500a. In some embodiments, the lower region 546a may extend in a direction more perpendicular to the longitudinal axis of the prosthesis 500a than parallel. For example, the lower region 546a may extend in a direction generally perpendicular to the longitudinal axis of the prosthesis 500a.

[0383] A portion of the outer frame 540a, such as the upper region 542a, may be attached to the inner frame 520a at or near the upper region 522a of the inner frame 520a. As shown in the example embodiment, the outer frame 540a may be sized such that the lower end of the outer frame 540a is located at or near the upper end or upper tip 526a of the anchoring structure 524a.

[0384] Next reference Figure 11B The prosthesis 500b shown may include an outer frame 540b comprising an upper region 542b, a middle region 544b, and a lower region 546b. The upper region 542b may include a longitudinally extending portion 548b and an outwardly extending portion 550b. Regions 542b, 544b, 546b, and portions 548b and 550b may be combined with the above description. Figure 11A The regions 542a, 544a, 546a and portions 548a, 550a described in the prosthesis 500a shown are similar or identical. A portion of the outer frame 540b, such as the upper region 542b, may be attached to the inner frame 520b at or near the upper region 522b of the inner frame 520b. As shown in the example embodiment, the outer frame 540b may be sized such that the lower end of the outer frame 540b is located above the upper end or upper tip 526b of the anchoring structure 524b.

[0385] Next reference Figure 11C The prosthesis 500c shown may include an outer frame 540c comprising an upper region 542c, a middle region 544c, and a lower region 546c. A portion of the outer frame 540c, such as the upper region 542c, may be attached to the inner frame 520c at or near the upper region 522c of the inner frame 520c. The upper region 542c may include a longitudinally extending portion 548c and an outwardly extending portion 550c. The middle region 544c may extend from the outwardly extending portion 550c. As shown in the example embodiment, the middle region 544c may extend in a direction generally parallel to the longitudinal axis of the prosthesis 500c. The lower region 546c may extend from the middle region 544c. As shown in the example embodiment, the lower region 546c may bend to extend radially outward away from the longitudinal axis of the prosthesis 500c. The lower region 546c may continue to bend such that the tip or end 552c of the lower region 546c extends upward. For example, the tip or end 552c of the lower region 546c may extend upward in a direction generally parallel to the longitudinal axis of the prosthesis 500c.

[0386] In some embodiments, the lower region 546c may function similarly to the anchoring structures described herein, such as, but not limited to, anchoring structures 124, 224. The aforementioned distal or terminal 552c may be positioned to contact or engage the ventricular-side natural mitral annulus, tissue extending beyond the ventricular-side natural annulus, the ventricular-side natural leaflet, and / or other tissue at or around the implantation site during one or more phases of the cardiac cycle, such as systole and / or diastole. For example, the distal or terminal 552c may be positioned to contact the ventricular-side of the natural mitral annulus and / or tissue extending beyond the ventricular-side of the natural annulus. In some embodiments, the distal or terminal 552c may advantageously provide a non-traumatic surface that can be used to contact or engage endovascular tissue without causing unnecessary or undesirable trauma to the tissue. For example, the distal or terminal 552c may form a flat, substantially flat, curved, or other non-sharp surface to allow the distal to engage and / or grasp tissue without having to puncture or penetrate the tissue. Circular ends or ring anchors can help prevent the frame from being intercepted on or near the processing location.

[0387] Next reference Figure 11D The prosthesis 500d shown may include an outer frame 540d comprising an upper region 542d, a middle region 544d, and a lower region 546d. As shown in the example embodiment, the outer frame 540d may have a generally bulbous shape, wherein the diameter of the middle region 544d is larger than the diameters of the upper region 542d and the lower region 546d. Furthermore, as shown in the example embodiment, the diameter of the upper region 542d may be larger than the diameter of the lower region 546d.

[0388] A portion of the outer frame 540d, such as the lower region 546d, may be attached to the inner frame 520d at or near the lower region 522d of the inner frame 520d. As shown in the example embodiment, the outer frame 540d may be sized such that its upper end is located at or near a plane passing through the upper end of the inner frame 520d and perpendicular to the longitudinal axis of the prosthesis 500d. The outer frame 540d may be sized such that its lower end is located axially below the tip or end 526d of the inner frame anchoring structure 524d. The outer frame 540d may be sized such that the diameter of its widest portion is greater than the widest portion of the inner frame anchoring structure 524d.

[0389] Next reference Figure 11E The prosthesis 500e shown may include an outer frame 540e comprising an upper region 542e, a middle region 544e, and a lower region 546e. As shown in the example embodiment, the outer frame 540e may have a generally bulbous shape, wherein the diameter of the middle region 544e is larger than the diameters of the upper region 542e and the lower region 546e. Furthermore, as shown in the example embodiment, the diameter of the upper region 542e may be larger than the diameter of the lower region 546e.

[0390] A portion of the outer frame 540e, such as the lower region 546e, may be attached to the inner frame 520e at or near the lower region 522e of the inner frame 520e. As shown in the example embodiment, the outer frame 540e may be sized such that its upper end is below a plane passing through the upper end of the inner frame 520e and perpendicular to the longitudinal axis of the prosthesis 500e. The outer frame 540e may be sized such that its lower end is axially below the tip or end 526e of the inner frame anchoring structure 524e. The outer frame 540e may be sized such that the diameter of its widest portion is smaller than the widest portion of the inner frame anchoring structure 524e. As shown in the example embodiment, the tip 526e of the inner anchoring structure 524e may be located at or near the middle region 544e of the outer frame 540e.

[0391] Next reference Figure 11F The prosthesis 500f shown may include an outer frame 540f comprising an upper region 542f, a middle region 544f, and a lower region 546f. Parts of the outer frame 540f, such as the middle region 544f and / or the lower region 546f, may be attached to the inner frame 520f at or near the middle region 522f of the inner frame 520f.

[0392] The upper region 542f may extend downward in a direction generally parallel to the longitudinal axis of the prosthesis 500f. The middle region 544f may extend from the upper region 542f. As shown in the example embodiment, the middle region 544f may extend radially inward toward the longitudinal axis of the prosthesis 500f. The lower region 546f may extend from the middle region 544f. As shown in the example embodiment, the lower region 546f may bend to extend radially outward away from the longitudinal axis of the prosthesis 500f. In some embodiments, the lower region 546f may continue to bend such that the tip or end 548f of the lower region 546f extends upward. For example, the tip or end 548f of the lower region 546f may extend upward in a direction generally parallel to the longitudinal axis of the prosthesis 500f. In some embodiments, the tip or end 548f of the lower region 546f may extend axially such that it is positioned at or near the middle region 544f.

[0393] In some embodiments, the lower region 546f may function similarly to the anchoring structures described herein, such as, but not limited to, anchoring structures 124, 224. The aforementioned distal or terminal portion 548f may be positioned to contact or engage the ventricular-side natural mitral annulus, tissue extending beyond the ventricular-side natural annulus, the ventricular-side natural leaflet, and / or other tissue at or around the implantation site during one or more phases of the cardiac cycle, such as systole and / or diastole. For example, the distal or terminal portion 548f may be positioned to contact the ventricular-side of the natural mitral annulus and / or tissue extending beyond the ventricular-side of the natural annulus. In some embodiments, the distal or terminal portion 548f may advantageously provide a non-traumatic surface that can be used to contact or engage endovascular tissue without causing unnecessary or undesirable trauma to the tissue. For example, the distal or terminal portion 548f may form a flat, substantially flat, curved, or other non-sharp surface to allow the distal portion to engage and / or grasp tissue without having to puncture or penetrate the tissue. Circular ends or ring anchors can help prevent the frame from being intercepted on or near the processing location.

[0394] Next reference Figure 11G The prosthesis 500g shown may include an outer frame 540g comprising an upper region 542g, a middle region 544g, and a lower region 546g. A portion of the outer frame 540g, such as the upper region 544g, may be attached to the inner frame 520g at or near the upper region 522g. As shown in the example embodiment, the outer frame 540g may be loosely attached to the inner frame 520g via a coupler 560g, allowing the outer frame 540g to move generally relative to the inner frame 520g. For example, the coupler 560g may be part of a skirt attached to both the outer frame 540g and the inner frame 520g.

[0395] The upper region 542g may extend downward in a direction generally parallel to the longitudinal axis of the prosthesis 500g. The middle region 544g may extend from the upper region 542g. As shown in the example embodiment, the middle region 544g may extend in a generally downward direction, such that the middle region 544g and the upper region 542g form a generally cylindrical portion. The lower region 546g may extend from the middle region 544g. As shown in the example embodiment, the lower region 546g may bend to extend radially inward toward the longitudinal axis of the prosthesis 500g. In some embodiments, the lower region 546g may extend in a direction more perpendicular to the longitudinal axis of the prosthesis 500g than parallel. For example, the lower region 546g may extend in a direction generally perpendicular to the longitudinal axis of the prosthesis 500g.

[0396] Next reference Figure 11H The prosthesis 500h shown may include a lower outer frame 540h and a upper outer frame 560h. The prosthesis 500h may be similar to other prostheses described herein, such as those combined with… Figure 11E The prosthesis 500e is described. For example, the lower outer frame 540h can be similar to the combination... Figure 11E The outer frame 540e is described. As shown in the example embodiment, the lower outer frame 540h and the upper outer frame 560h can form an overall bulbous shape, wherein the diameter of the middle region is larger than the diameter of the upper region and the diameter of the lower region. The lower outer frame 540h can be attached to the inner frame 520h along the lower region of the lower outer frame 540h. The upper outer frame 560h can be attached to the inner frame 520h along the upper region of the upper outer frame 540h.

[0397] The upper outer frame 560h can extend downwards and radially outwards. As shown, the diameter of the upper end of the upper outer frame 560h can be smaller than the upper end of the lower outer frame 560h. The diameter of the lower end of the upper outer frame 560h can be larger than the upper end of the lower outer frame 560h. As shown, at least when the prosthesis 500h is in a partially or fully expanded state, the upper outer frame 560h can partially overlap with a portion of the lower outer frame 540h.

[0398] The shape of the upper outer frame 560h facilitates the re-capture of the prosthesis 500h. In some embodiments, the prosthesis 500h is deployed sequentially, with the lower region of the prosthesis 500h deployed before the upper region of the prosthesis 500h. For example, a sheath (not shown) that holds the prosthesis 500h in a wrinkled or folded configuration can be retracted upwards. The upper region of the prosthesis 500h can remain in a wrinkled or folded configuration while allowing the remaining portion of the prosthesis 500h, for example... Figure 56FThe deployment is shown. If the user decides to re-capture the prosthesis 500h to reposition or remove it, the user can advance the sheath downwards over the prosthesis 500h. This process can be facilitated by the shape and / or attachment of the upper end of the upper outer frame 560h. Furthermore, as the sheath is advanced downwards, the upper outer frame 560h can fold or wrinkle over the lower outer frame 540h, thereby causing the lower outer frame 540h to fold.

[0399] Next reference Figure 11I The prosthesis 500i shown may include a lower outer frame 540i and an upper outer frame 560i. The prosthesis 500i may be similar to other prostheses described herein, such as those combined with… Figure 11H The prosthesis 500h is described. As shown, the upper outer frame 560i and the lower outer frame 540i can be formed by non-overlapping structures (such as struts).

[0400] Next reference Figure 11J The prosthesis 500j shown may include an outer frame 540j comprising an upper region 542j, a middle region 544j, and a lower region 546j. As shown in the example embodiment, the outer frame 540j may have a generally bulbous shape, wherein the diameter of the middle region 544j is larger than the diameters of the upper region 542j and the lower region 546j. Portions of the outer frame 540j, such as the upper region 542j and / or the lower region 546j, may be attached to the inner frame 520j at or near the upper region 522j and / or the lower region 524j. The outer frame 540j may be formed from a plurality of pillars and / or units that allow the outer frame to fold or crumple into a configuration that generally matches the size and / or shape of the inner frame 520j. For example, when the outer frame 540j is in a crumpled configuration, the length of the outer frame 540j may generally match the length of the inner frame 520j. When expanding, the differences in the unit structure between the upper region 542j, the middle region 544j, and the lower region 546j can allow these regions to expand to different degrees, as shown. For example, in some embodiments, the pillar geometry of the middle region 544j may differ from the pillar geometry of the upper region 542j and / or the lower region 546j.

[0401] The shape of the outer frame 540j facilitates the re-capture of the prosthesis 500j. In some embodiments, the prosthesis 500j is deployed sequentially, with the lower region of the prosthesis 500h deployed before the upper region of the prosthesis 500h. For example, the upper region of the prosthesis 500j can remain in a wrinkled or folded configuration while allowing the remaining portions of the prosthesis 500j, for example... Figure 56FThe expansion is shown. If the user decides to re-capture the prosthesis 500j to reposition or remove it, the user can push the sheath downwards onto the prosthesis 500j. This process can be facilitated by the shape and / or attachment of the upper end of the outer frame 540j.

[0402] Next reference Figure 1 The prosthesis 500k shown in Figure lk includes an outer frame 540k that may comprise an upper region 542k, a middle region 544k, and a lower region 546k. As shown in the example embodiment, the outer frame 540k may have a generally bulbous shape, wherein the diameter of the middle region 544k is larger than the diameters of the upper region 542k and the lower region 546k. The shape of the outer frame 540k can facilitate the re-capture of the prosthesis 500k, for reasons similar to those of bonding. Figure 11J The prosthesis 500j shown is one of those described.

[0403] A portion of the outer frame 540k, such as the upper region 542k and / or the lower region 546k, may be attached to the inner frame 520k at or near the upper region 522k and / or the lower region 524k. As shown, the coupling between the upper region 542k of the outer frame 540k and the inner frame 520k may be movable. This facilitates the folding of the outer frame 540k because the upper region 542k can move independently of the inner frame 520k. In some embodiments, the upper region 542k of the outer frame 540k may be coupled to the inner frame 520k via a guide rail or track to allow the upper region 542k to slide relative to the inner frame 520k. This can advantageously maintain the upper end of the outer frame 540k with a diameter matching that of the inner frame 520k. In some embodiments, the upper region 542k of the outer frame 540k may be coupled via a method similar to a coupling. Figure 11G The coupler 560g discussed is coupled to the inner frame 520k. For example, the coupler 560g may be part of a skirt. Although the coupling between the upper region 542k of the outer frame 540k and the inner frame 520k has been described as movable, it should be understood that the lower region 546k of the outer frame 540k may be movably coupled to the inner frame 520k, instead of or in combination with the movable coupling between the upper region 542k and the inner frame 520k.

[0404] Implementation methods of mesh anchoring structure

[0405] In some embodiments, the prosthesis described herein may include a mesh or braided anchoring structure. It should be understood that the mesh or braided anchoring structure may be used in combination with other anchoring structures described herein, or as a replacement for one or more of the anchoring structures described herein.

[0406] Next reference Figure 12-14 This document illustrates an embodiment of a prosthesis 600 in an expanded configuration. The prosthesis 600 may include a frame 620 and a valve body 660. The longitudinal axis of the prosthesis 600 may be defined as a central axis extending through the center of the prosthesis 600 between its upper and lower ends. In some cases, the prosthesis 600 may be oriented such that its upper end is the proximal portion and its lower end is the distal portion. The valve body 660 may be similar to or identical to other valve bodies described herein (such as, but not limited to, valve bodies 160, 260, 760, 870, 970). Therefore, reference should be made to the discussion of such valve bodies.

[0407] As shown in the example embodiment, frame 620 may include frame body 622 and anchoring structure 624. Frame body 622 may include upper region 626, middle region 628, and lower region 630. As shown, frame body 622 may have a generally cylindrical shape such that the diameters of upper region 626, middle region 628, and lower region 620 are generally constant. However, it should be understood that the diameters of upper region 626, middle region 628, and / or lower region 630 may be different. For example, in some embodiments, the diameter of middle region 628 may be larger than that of upper region 626 and lower region 630, such that frame body 622 has a generally bulbous shape. In some embodiments, the diameter of lower region 630 may be larger than the diameter of upper region 626. In other embodiments, the diameter of upper region 626 may be larger than the diameter of lower region 630. In some cases, frame 620 may be oriented such that the upper region 626 is the proximal portion and the lower region 630 is the distal portion. Furthermore, although frame body 622 has been described and exemplified as cylindrical, it should be understood that all or part of frame body 622 may have a non-circular cross-section, such as, but not limited to, D-shaped, oval, or other oval cross-sectional shapes. Frame body 622 may share features that are identical or at least similar to those of the frames described herein (such as, but not limited to, inner frames 120, 220, 400, 520a-g), such as structural and / or functional features.

[0408] As shown, the anchoring structure 624 may be positioned at or near the upper region 626 of the frame body 622. However, it should be understood that, based on the configuration and implantation location of the prosthesis 600, the anchoring structure 624 may be positioned along other regions of the frame body 622, such as the middle region 630 and / or the lower region 628. The anchoring structure 624 may include a body portion 632 formed of wire mesh. The body portion 632 may be positioned such that it is radially outward of the frame body 622. The body portion 632 may be relatively flexible, elastic, and / or tough. For example, the construction of the body portion 632, such as the material used and / or the mesh geometry, may be selected to provide this flexibility, elasticity, and / or toughness. In some embodiments, the body portion 632 may be formed of metal, including but not limited to shape memory metals such as nitinol. The body portion 632 may be in the form of a braided tube. In some embodiments, the body portion 632 may be formed separately from other portions of the frame 620. The main body portion 632 may be attached to the frame 620 using any of the fasteners and / or techniques described herein, including but not limited to mechanical fasteners such as stitches, U-bolts, screws, rivets, connecting components (e.g., joints and grooves, which may be on the frame 620 and the main body portion 632), and any other desired type of mechanical fastener; chemical fasteners such as adhesives and any other desired type of chemical fastener; fastening techniques such as fusion welding, brazing, sintering, and any other desired type of fastening technique; and / or combinations of such fasteners and techniques. The frame 620 and the main body portion 632 may be attached indirectly via intermediate components (such as skirts). In other embodiments, the main body portion 632 may be integrally or monolithically formed with other portions of the frame 620.

[0409] The flexibility, elasticity, and / or toughness of the body portion 632 advantageously allows it to conform to the anatomical structures of the body cavity in which it resides, such as the tissue of the natural heart wall, the natural valve annulus, and / or the leaflets. In some cases, such as when the body portion 632 is positioned within the natural mitral valve, the body portion 632 can conform to the shape of the mitral valve annulus, such that the upper region of the body portion 632 extends on the atrial side of the natural mitral valve annulus, the middle region of the body portion 632 conforms to the inner circumference of the natural mitral valve annulus, and / or the lower region of the body portion 632 contacts the leaflet portion. Furthermore, this flexibility, elasticity, and / or toughness advantageously allows the body portion 632 to be folded to a smaller diameter during delivery, thereby allowing the use of smaller-sized delivery devices.

[0410] The anchoring structure 624 may include one or more protrusions or barbs 634. These protrusions 634 may be positioned along the body portion 632. As shown in the example embodiment, these protrusions 634 may advantageously enhance the fixation of the anchoring structure 624 to tissues within the body cavity where the anchoring structure 624 is located, such as tissues of the natural heart wall, natural valve annulus, and / or natural leaflets. In some cases, the protrusions 634 may be oriented to inhibit or limit upward movement of the prosthesis 600. For example, in the case where the prosthesis 600 is positioned within the natural mitral valve, the protrusions 634 may be oriented to inhibit or limit upward movement of the prosthesis 600 during systole. Furthermore, these protrusions 634 may advantageously promote inward tissue growth by activating fibroblasts and inducing tissue proliferation. The length and orientation of the protrusions 634 may be selected to reduce trauma while providing sufficient engagement with tissue and sufficient inward tissue growth.

[0411] Anchoring structure 624 may include one or more arms or blades 636. As shown, anchoring structure 624 may include eight arms or blades 636; however, it should be understood that anchoring structure 624 may include more or fewer arms or blades. Arms or blades 636 may be attached to or near the upper region 626 of frame body 622. Arms or blades 638 may extend radially outward relative to the longitudinal axis of prosthesis 600. As shown in the example embodiment, arms or blades 636 may be positioned to extend above body portion 632. Arms or blades 636 may be formed of wire mesh. Arms or blades 636 may be relatively flexible, elastic, and / or tough. For example, the construction of arms or blades 636, such as the material used and / or mesh geometry, may be selected to provide such flexibility, elasticity, and / or toughness. The construction of the arm or blade 636 can be selected to provide sufficient engagement with the tissue during use, while reducing the force applied when the prosthesis 600 is in a wrinkled or folded configuration.

[0412] In some embodiments, the arm or blade 636 may be formed of metal, including but not limited to shape memory metals such as nitinol. The arm or blade 636 may be woven. In some embodiments, the arm or blade 636 may be formed separately from other parts of the frame 620, such as the body portion 632. The arm or blade 636 may be attached to other parts of the frame 620, such as the body portion 632, using any of the fasteners and / or techniques described herein, including but not limited to mechanical fasteners such as stitches, U-bolts, screws, rivets, connecting members (e.g., joints and slots that may be on the arm or blade 636 and other parts of the frame 620), and any other desired type of mechanical fastener; chemical fasteners such as adhesives and any other desired type of chemical fastener; fastening techniques such as fusion welding, brazing, sintering, and any other desired type of fastening technique; and / or combinations of such fasteners and techniques. The arm or blade 636 and other portions of the frame 620 may be indirectly attached via intermediate components (such as skirts). In other embodiments, the arm or blade 636 may be integrally or integrally formed with the frame 620 and / or other portions of the body portion 632.

[0413] The flexibility, elasticity, and / or toughness of the arm or blade 636 advantageously allows it to conform to the anatomical structure of the body cavity in which it is located, such as the tissue of the natural heart wall, the natural valve annulus, and / or leaflets. In some cases, such as when the arm or blade 636 is positioned within the natural mitral valve, it may conform to the shape of the atrial wall. Furthermore, this flexibility, elasticity, and / or toughness advantageously allows the body portion 632 to be folded to a smaller diameter during delivery, thereby allowing the use of a smaller-sized delivery device.

[0414] Although not shown, the frame body 622 may include an anchoring structure positioned below the anchoring structure 624. This anchoring structure may share features, such as structural and / or functional features, that are identical to or at least similar to those of the anchoring structures described herein (including, but not limited to, inner frame anchoring structures 124, 224, 524d, 524e and lower frame anchoring structures 726, 826, 926, 1106, 1220).

[0415] Next reference Figure 15This example illustrates an embodiment of a prosthesis 700 in an expanded configuration. The prosthesis 700 may include a frame 720, a valve body 760, and a skirt 780. The longitudinal axis of the prosthesis 700 may be defined as a central axis extending through the center of the prosthesis 700 between its upper and lower ends. In some cases, the prosthesis 700 may be oriented such that its upper end is the proximal portion and its lower end is the distal portion. The valve body 760 may share features that are identical or at least similar to those of other valve bodies described herein (such as, but not limited to, valve bodies 160, 260, 660, 870, 970), such as structural and / or functional features.

[0416] Frame 720 may include a frame body 722, an upper anchoring structure 724, a lower anchoring structure 726, and an intermediate anchoring structure 728. Frame body 722 may include an upper region 730, an intermediate region 732, and a lower region 734. As shown, frame body 722 may have a generally cylindrical shape, such that the diameters of the upper region 730, the intermediate region 732, and the lower region 734 are generally constant. However, it should be understood that the diameters of the upper region 730, the intermediate region 732, and / or the lower region 734 may be different. For example, in some embodiments, the diameter of the intermediate region 732 may be larger than that of the upper region 730 and the lower region 734, such that frame body 722 has a generally bulbous shape. In some embodiments, the diameter of the lower region 734 may be larger than the diameter of the upper region 730. In other embodiments, the diameter of the upper region 730 may be larger than the diameter of the lower region 734. Furthermore, although the frame body 722 has been described and exemplified as cylindrical, it should be understood that all or part of the frame body 722 may have a non-circular cross-section, such as, but not limited to, D-shaped, oval, or other oval cross-sectional shapes. The frame body 722 may share features that are the same as or at least similar to those of frames such as inner frames 120, 220, 400, 520a-g, such as structural and / or functional features.

[0417] The upper anchoring structure 724 may extend radially outward from the longitudinal axis of the prosthesis 700. In this way, the upper anchoring structure 724 may form a flared portion or shoulder 736 of the frame 720. As shown in the example embodiment, a portion of the upper anchoring structure 724 may extend radially outward via a bend 738 that originates at or near the upper end of the upper region 730 of the frame body 722. The bend 738 may be about a circumferential axis such that the upper anchoring structure 724 extends in a direction more perpendicular to the longitudinal axis of the prosthesis 700 than the frame body 722. In some embodiments, the bend 738 may generally form an arc with an angle between about 20 degrees and about 90 degrees. For example, as shown in the example embodiment, the arc may have an angle of about 60 degrees. In some embodiments, the bend 738 may form an arc with an angle between about 30 degrees and about 70 degrees. The radius of curvature of the arc can be constant, so that the curved portion 738 forms an arc, or it can vary along the length of the curved portion 738.

[0418] The upper anchoring structure 724 may include a second bend 740 above the bend 738. The bend 740 may be about a circumferential axis such that the extension direction of the portion of the upper anchoring structure 724 above the second bend 740 is less perpendicular to the longitudinal axis of the prosthesis 700 compared to the portion of the upper anchoring structure 724 below the second bend 740. In some embodiments, the bend 740 may continue such that the end of the upper anchoring structure 724 extends radially toward the longitudinal axis of the prosthesis 700. In some embodiments, the second bend 740 may generally form an arc with an angle between about 20 degrees and about 90 degrees. For example, as shown in the example embodiment, the arc may have an angle of about 90 degrees. In some embodiments, the second bend 740 may form an arc with an angle between about 45 degrees and about 135 degrees. The radius of curvature of the arc may be constant, such that the second bend 740 forms an arc, or it may vary along the length of the second bend 740.

[0419] Continue to refer to Figure 15The frame 720 shown has a lower anchoring structure 726 that extends generally downward from above the lower end of the lower region 734 of the inner frame body 722, and / or generally extends radially outward along the longitudinal axis of the prosthesis 700. As shown in the example embodiment, the lower anchoring structure 726 may also extend upward toward its end 742. As will be discussed in further detail below, components of the frame 120, such as the lower anchoring structure 726, can be used to attach or secure the prosthesis 700 to a natural valve. For example, in some embodiments, the lower anchoring structure 726 can be used to attach or secure the prosthesis 700 to a natural valve, such as a natural mitral valve. In such embodiments, the lower anchoring structure 726 can be positioned to contact or engage the ventricular-side natural mitral annulus, tissue beyond the ventricular-side natural annulus, the ventricular-side natural leaflet, and / or other tissue at or around the implantation site during one or more phases of the cardiac cycle, such as systole and / or diastole. The lower anchoring structure 726 can advantageously eliminate, suppress, or limit the upward movement of the prosthesis 700 when subjected to an upward force (such as a force applied to the prosthesis 700 during systole).

[0420] An intermediate anchoring structure 728 may be positioned in or near the intermediate region 732 of the frame body 722. The intermediate anchoring structure 728 may be positioned radially outward of the frame body 722. The intermediate anchoring structure 728 may be relatively flexible, elastic, and / or tough. For example, the construction of the intermediate anchoring structure 728, such as the material used and / or the mesh geometry, may be selected to provide this flexibility, elasticity, and / or toughness. In some embodiments, the intermediate anchoring structure 728 may be formed of metal, such as, but not limited to, stainless steel, cobalt-chromium, and shape memory metals such as nitinol. The intermediate anchoring portion 728 may be in the form of a wire mesh. In some embodiments, the intermediate anchoring portion 728 may be formed separately from the other parts of the frame 720. The intermediate anchoring portion 728 can be attached to other portions of the frame 720 using any fasteners and / or techniques described herein, including but not limited to mechanical fasteners such as stitches, U-bolts, screws, rivets, connecting members (e.g., joints and grooves on the frame 720 and the intermediate anchoring structure 728), and any other desired type of mechanical fastener; chemical fasteners such as adhesives and any other desired type of chemical fastener; fastening techniques such as fusion welding, brazing, sintering, and any other desired type of fastening technique; and / or combinations of such fasteners and techniques. The frame 720 and the intermediate anchoring structure 728 can be attached indirectly via an intermediate component (such as a skirt 780). In some embodiments, the intermediate anchoring structure 728 can be held in place by wrapping the skirt 780 around the intermediate anchoring structure 728 and attaching the ends of the skirt 780 to the frame 720. In some embodiments, the intermediate anchoring portion 728 may be integrally or integrally formed with other portions of the frame 720.

[0421] The flexibility, elasticity, and / or toughness of the intermediate anchoring structure 728 can advantageously allow it to conform to the anatomical structures of the body cavity in which it is located, such as the tissue of the natural heart wall, the natural valve annulus, and / or leaflets. In some cases, such as when the intermediate anchoring structure 728 is positioned within the natural mitral valve, it can conform to the shape of the mitral valve annulus such that the anchoring structure 728 contacts or extends on one or more of the following: the atrial side of the natural mitral valve annulus, the inner periphery of the natural mitral valve annulus, and portions of the leaflets. Furthermore, this flexibility, elasticity, and / or toughness can advantageously allow the intermediate anchoring structure 728 to fold to a smaller diameter during delivery, thereby allowing the use of smaller-sized delivery devices.

[0422] As shown in the example embodiment, at least a portion of the intermediate anchoring structure 728 may be radially positioned between the lower anchoring structure 726 and the frame body 722. In this way, tissue within the body cavity may be positioned between the lower anchoring structure 726 and the intermediate anchoring structure 728. In some embodiments, portions of the lower anchoring structure 726 and the intermediate anchoring structure 728 are sufficiently close to each other such that the tissue within the body cavity is clamped or engaged. For example, in the case where the prosthesis 700 is positioned within the natural mitral valve, the natural mitral valve annulus and / or leaflet may be clamped or engaged between the lower anchoring structure 726 and the intermediate anchoring structure 728. This can advantageously enhance the fixation of the prosthesis 700 to the body cavity. As shown in the example embodiment, the diameter of the intermediate anchoring structure 728 may be larger at or near the tip or end of the lower anchoring structure 726, and may have a smaller diameter near the lower end of the intermediate anchoring structure 728. This can advantageously allow for greater clamping or pincer force at or near the tip of the lower anchoring structure 726, while providing ample space for body cavity tissues such as natural leaflets located between the frame body 722, the lower anchoring structure 728, and the intermediate anchoring structure 728.

[0423] As described above, one or more of the anchoring structures 724, 726, and 728 can contact or engage the natural valve annulus, such as the natural mitral valve annulus, tissue extending beyond the natural valve annulus, natural leaflets, and / or other tissue at or around the implantation site. When the prosthesis 700 is positioned within the natural mitral valve, the upper anchoring structure 724 can be positioned on the atrial side of the natural mitral valve annulus, the lower anchoring structure 726 can be positioned on the ventricular side of the natural mitral valve annulus, and the intermediate anchoring structure 728 can be positioned within the annulus. Although the anchoring structures 724, 726, and 728 have been exemplified as extending from the upper region 730, lower region 734, and intermediate region 732 of the frame body 722, respectively, it should be understood that the anchoring structures 724, 726, and 728 can be positioned along any other portion of the frame body 722 as needed. Furthermore, although three anchoring structures 724, 726, and 728 are included in the example embodiment, it is contemplated that fewer or more sets of anchoring structures may be used.

[0424] Anchoring structures 724, 726, and 728 are preferably positioned along the prosthesis 700, with at least a portion of the shortened portion positioned between anchoring structures 724, 726, and 728 such that portions of anchoring structures 724, 726, and 728 will move closer together as the prosthesis 700 expands. As an example, this allows anchoring structures 724, 726, and 728 on opposite sides of the natural mitral annulus to be close together, thereby securing the prosthesis to the mitral valve. In some embodiments, anchoring structures 724, 726, and 728 may be positioned such that they do not simultaneously contact opposite portions of the natural mitral annulus. For example, in some cases, the intermediate anchoring structure 726 and the upper anchoring structure 728 may contact the natural mitral annulus, while the upper anchoring structure 724 may not contact the natural mitral annulus. This can be beneficial when the upper anchoring structure 724 is used to provide stability and help align the prosthesis. In some embodiments, the anchoring structures 724, 726, and 728 can be positioned such that the anchoring structures 724 and 726 grip the opposite side of the natural mitral valve annulus.

[0425] Next reference Figure 15 The skirt 780 shown may be attached to the frame 720 and / or the valve body 760. The skirt 780 may be positioned and secured to part or all of the exterior and / or interior of the frame 720. As shown, the skirt 780 may extend from the valve body 760 and along the interior of the upper anchoring structure 724. This can advantageously serve as a collector or funnel to guide blood into the inlet of the valve body 760. The skirt 780 may surround the end of the upper anchoring structure 724 and extend downwards. As shown, the skirt 780 may extend between the lower anchoring structure 726 and the intermediate anchoring structure 728. The skirt 780 may be attached to the frame 720 and / or the valve body 760 below the intermediate anchoring structure 728.

[0426] The skirt 780 may be annular and may extend circumferentially around the frame 720. The skirt 780 may prevent or inhibit backflow of fluids (such as blood) around the prosthesis 700. For example, when the skirt 780 is positioned annularly around the outside of the frame 720, it may establish an axial barrier to fluid flow outside the frame 720 when deployed within a body cavity such as a natural valve annulus. The skirt 780 may promote inward tissue growth between the skirt 780 and the natural tissue of the body cavity. This may further help prevent blood leakage around the prosthesis 700 and may provide further fixation of the prosthesis 700 to the body cavity. In some embodiments, the skirt 780 may be tautly attached to the frame 720 such that the skirt 780 is generally immobile relative to the frame 720. In some embodiments, the skirt 780 may be loosely attached to the frame 720 such that the skirt 780 is movable relative to the frame 720. In some embodiments, blood flow into the skirt 780 may be permitted.

[0427] Although the prosthesis 700 has been described as including a frame 720, a valve body 760, and a skirt 780, it should be understood that the prosthesis 700 does not need to include all components. For example, in some embodiments, the prosthesis 700 may include the frame 720 and the valve body 760, while omitting the skirt 780. Furthermore, although the components of the prosthesis 700 have been described and exemplified as separate components, it should be understood that one or more components of the prosthesis 700 may be formed integrally or collectively.

[0428] Next reference Figure 16-19 This illustrates an embodiment of a prosthesis 800 in an expanded configuration, or a component of the prosthesis 800. The prosthesis 800 may include a frame 820, a valve body 870, and a skirt 890. The longitudinal axis of the prosthesis 800 may be defined as a central axis extending through the center of the prosthesis 800 between its upper and lower ends. In some cases, the prosthesis 800 may be oriented such that its upper end is the proximal portion and its lower end is the distal portion.

[0429] First refer to Figure 18-19 The frame 820 shown may include a frame body 822, an upper anchoring structure 824, a lower anchoring structure 826, and an intermediate anchoring structure 828. The frame body 822 may include an upper region 830, an intermediate region 832, and a lower region 834. As shown, the frame body 822 may have a generally cylindrical shape, such that the diameters of the upper region 830, the intermediate region 832, and the lower region 834 are generally constant. However, it should be understood that the diameters of the upper region 830, the intermediate region 832, and / or the lower region 834 may be different.

[0430] In some embodiments, the diameter of the frame body 822 may be between about 40% and about 90% of the diameter of the natural valve annulus, between about 60% and about 85% of the diameter of the natural valve annulus, between 70% and about 80% of the diameter of the natural valve annulus, any other subrange between these ranges, or any other desired percentage. In some embodiments, the diameter of the frame body 822 may 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, about 29 mm when expanded, in any other subrange between these ranges when expanded, or any other desired diameter when expanded. Although the frame body 822 has been described and exemplified as cylindrical or having a circular cross-section, it should be understood that all or part of the frame body 822 may have a non-circular cross-section, such as, but not limited to, D-shaped, oval, or other oval cross-sectional shapes.

[0431] In other embodiments, the diameter of portions of the frame body 822, such as the upper region 830, the middle region 832, and / or the lower region 834, can be selected such that the frame body 822 is positioned around the periphery of the body cavity. For example...

Claims

1. A replacement heart valve prosthesis, the replacement heart valve prosthesis comprising: A valve body comprising a plurality of flexible leaflets made of pericardium; and A self-expanding support structure surrounds and supports the valve body, the support structure comprising: The valve frame is generally cylindrical, and the valve frame has an upper part, a middle part and a lower part; A plurality of anchors coupled to the lower portion, each of the anchors being configured to extend in a downward direction when the valve frame is in a constricted configuration, and wherein the plurality of anchors are configured to flip from the downward direction to a second direction extending radially outward and upward when the valve frame transitions to an expanded configuration; and A conformal sealing frame, the sealing frame being positioned radially outward of the valve frame and sized for implantation in a natural heart valve, the sealing frame having an upper, middle and lower portion, wherein the upper portion of the sealing frame is attached to the upper portion of the valve frame.

2. The prosthesis of claim 1, wherein the heart valve prosthesis is configured to capture the leaflet of the natural heart valve between the plurality of anchors and the sealing frame, thereby anchoring the heart valve prosthesis in the natural heart valve and forming a seal.

3. The prosthesis of claim 1, wherein the upper portion of the valve frame includes a locking connector with an enlarged head.

4. The prosthesis of claim 1, wherein the valve frame comprises at least two circumferentially arranged closure units.

5. The prosthesis of claim 1, wherein each of the plurality of anchors terminates at a flared end.

6. The prosthesis of claim 5, wherein the flared ends of at least some of the plurality of anchors are covered by padding.

7. The prosthesis of claim 1, wherein only the upper portion of the sealing frame is coupled to the upper portion of the valve frame.

8. The prosthesis of claim 1, wherein the upper portion of the sealing frame is coupled to the upper portion of the valve frame by sutures.

9. The prosthesis of claim 8, wherein the upper portion of the sealing frame and the valve frame includes a plurality of eyelets configured to be aligned with each other to facilitate suturing the upper portion of the sealing frame to the upper portion of the valve frame.

10. The prosthesis of claim 1, wherein when the sealing frame is in an expanded configuration, the sealing frame has a generally bulbous shape.

11. The prosthesis of claim 1, wherein the upper portion of the sealing frame includes a plurality of struts having holes.

12. The prosthesis of claim 1, wherein the sealing frame has a curved portion formed at the junction between the upper and middle portions of the sealing frame, such that the middle portion of the sealing frame extends in a direction more parallel to the longitudinal axis of the prosthesis than the upper portion of the sealing frame.

13. The prosthesis of claim 1, wherein the sealing frame is more flexible than the valve frame.

14. The prosthesis of claim 1, wherein, in the expanded configuration, the central portion of the sealing frame has a diameter between 35 mm and 55 mm.

15. The prosthesis of claim 1, wherein at least a portion of the sealing frame is covered by fabric.

16. The prosthesis of claim 1, wherein the lower portion of the sealing frame has a larger diameter than the upper portion of the sealing frame.

17. The prosthesis of claim 16, wherein the middle portion of the sealing frame has a larger diameter than the lower portion of the sealing frame.

18. A tricuspid valve replacement prosthesis, the prosthesis comprising: An expandable frame configured to expand and contract radially for deployment within a natural tricuspid valve, the expandable frame having a longitudinal axis between an inlet and an outlet end, the expandable frame comprising: An inner frame, comprising an inner frame inlet, a middle section, and an inner frame outlet, the inner frame outlet having a plurality of anchor posts configured to extend downward in a collapsed configuration and to flip from the downward direction to a second direction such that the anchor posts extend radially outward toward the inner frame inlet when the expandable frame is in an expanded configuration; and An outer frame is positioned radially outside the inner frame. The outer frame includes an outer frame inlet end coupled to the inlet end of the inner frame, a middle portion, and an outer frame outlet end, wherein, in an expanded configuration, the outer frame inlet end has a smaller diameter than the middle portion and the outer frame outlet end. An outer skirt that covers at least a portion of the outer surface of the outer frame; 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, opposite direction; and An inner skirt is attached to the valve body and the outer skirt, wherein a first end of the inner skirt is coupled to the valve body along a portion of the valve body near the inner frame, and a second end of the inner skirt is attached to a lower region of the outer skirt.

19. The prosthesis of claim 18, further comprising at least one pad at the flared end of at least one of the plurality of anchoring struts.

20. The prosthesis of claim 18, wherein the inner frame inlet end includes a plurality of locking joints, each having an enlarged head.

21. The prosthesis of claim 18, wherein the middle portion of the inner frame comprises a plurality of rows of closed units.

22. The prosthesis of claim 18, wherein the middle portion of the outer frame comprises at least one row of closing units.

23. The prosthesis of claim 18, wherein the middle portion of the inner frame is generally cylindrical.

24. The prosthesis of claim 18, wherein the inner frame entrance end is sutured to the outer frame entrance end.

25. A system for replacing a natural heart valve, the system comprising: A delivery catheter configured to be advanced through the patient’s vascular system to the location of a natural heart valve; and A self-expanding replaceable heart valve prosthesis, configured to be held by the delivery catheter during advancement of the delivery catheter to the location of the natural heart valve, the prosthesis being configured to expand from a constricted configuration to an expanded configuration when not constrained by the delivery catheter, the prosthesis comprising: An inner frame including an inlet end and an outlet end, the inlet end including a plurality of locking connectors configured to couple to the delivery catheter during advancement of the delivery catheter to the position of the natural heart valve, the outlet end including a plurality of anchoring members configured to extend in a downward direction when the prosthesis is in the constricted configuration and to flip from the downward direction to a second direction extending radially outward and toward the inlet end when the prosthesis is in the expanded configuration to capture the leaflet of the natural heart valve; An outer frame having an outer frame body having a central region sized to contact the annulus of the natural heart valve, wherein, when the prosthesis is in the expanded configuration, the central region has a diameter larger than the upper and lower regions of the outer frame body; and The valve body includes a plurality of leaflets configured to allow blood to flow through the prosthesis in only one direction.

26. The system of claim 25, wherein the anchoring component comprises an elongated filament having an enlarged, non-invasive end.

27. The system of claim 25, wherein the anchoring component is covered with a pad.

28. The system of claim 25, wherein the locking joint includes an enlarged head.

29. The system of claim 25, wherein the delivery catheter includes an outer sheath assembly configured to retain the prosthesis in the constricted configuration and retract proximally to not cover the prosthesis, thereby allowing the prosthesis to expand at least partially when no longer covered by the outer sheath assembly.

30. The system of claim 25, wherein the delivery catheter includes an internal retaining member comprising one or more slots configured to engage with the locking connector of the prosthesis.

31. The system of claim 25, wherein the prosthesis is formed of shape memory metal.

32. The system of claim 25, wherein the prosthesis further includes a skirt extending between the inner frame and the outer frame.

33. The system of claim 25, wherein a gap is provided between the inner frame and the outer frame.

34. The system of claim 25, wherein the entrance end of the inner frame is stitched to the upper region of the outer frame.

35. The system of claim 25, wherein the inner frame comprises at least two rows of closed units.

36. The system of claim 25, wherein the middle region of the outer frame includes at least one row of closed units.

37. A replacement heart valve prosthesis, the prosthesis comprising: A self-expanding frame configured to radially expand and contract between a compression configuration and an expansion configuration for deployment within a natural heart valve, the self-expanding frame comprising: An inner frame, comprising an upper region, a middle region, and a lower region, includes a plurality of anchors extending downward in the compressed configuration of the self-expanding frame, and flipped from the downward direction to a second direction such that, in the expanded configuration of the self-expanding frame, the plurality of anchors extend radially outward from the lower region and upward toward the upper region; and An outer frame, positioned radially outside the inner frame, the outer frame including a frame body, wherein when the self-expanding frame is in the expanded configuration, the frame body is radially positioned between the plurality of anchors of the inner frame and the middle region of the inner frame.

38. The prosthesis of claim 37, further comprising a valve body positioned within and coupled to the inner frame, the valve body including a plurality of leaflets that allow flow in a first direction and prevent flow in a second opposite direction.

39. The prosthesis of claim 37, wherein at least a portion of the inner frame is covered by fabric.

40. The prosthesis of claim 37, wherein at least a portion of the outer frame is covered by fabric.

41. The prosthesis of claim 37, wherein at least some of the plurality of anchors include an enlarged non-traumatic distal end.

42. The prosthesis of claim 41, wherein at least some of the plurality of anchors have their enlarged, non-traumatic ends covered with padding.

43. The prosthesis of claim 42, wherein the padding is covered in fabric.

44. The prosthesis of claim 37, wherein the upper region of the inner frame includes a plurality of locking connectors configured to engage with a retaining member of the delivery catheter.

45. The prosthesis of claim 44, wherein the locking connector includes an enlarged head.

46. ​​The prosthesis of claim 37, wherein the self-expanding frame is formed of shape memory metal.

47. The prosthesis of claim 37, wherein the upper region of the inner frame is attached to the upper region of the outer frame.

48. The prosthesis of claim 37, wherein the upper region of the inner frame includes a plurality of eyelets and wherein the upper region of the outer frame includes a plurality of eyelets, the plurality of eyelets of the upper region of the outer frame being configured to align with the plurality of eyelets of the upper region of the inner frame.

49. The prosthesis of claim 48, wherein the upper region of the inner frame is sutured to the upper region of the outer frame via a plurality of eyelets of the inner frame and the outer frame.

50. The prosthesis of claim 37, wherein the inner frame includes struts and holes arranged to form a plurality of rows of units.

51. The prosthesis of claim 37, wherein the outer frame includes struts and holes arranged to form at least one row of units.

52. A replacement valve prosthesis, comprising: The frame body includes a plurality of circumferentially expandable pillars, wherein at least some of the pillars form at least two rows of units. The frame body includes a longitudinal axis that extends from the upper end of the frame body to the lower end of the frame body and passes through the center of the frame body. An upper anchoring component extends radially outward from the longitudinal axis of the frame body, and the upper anchoring component forms a flared portion or shoulder of the frame body; A plurality of lower anchors extend from the lower region of the frame body and are configured to extend downward when the frame body is in a constricted configuration and to flip from the downward direction to a second direction extending radially outward and upward toward the upper end of the frame body when the frame body is in an expanded configuration. The plurality of lower anchoring elements include non-traumatic tips, and The plurality of lower anchors have a length such that the ends of the anchors extend upward beyond the lower region of the frame body.

53. The prosthesis of claim 52, wherein the proximal anchoring component comprises a plurality of anchors.

54. The prosthesis of claim 53, wherein the plurality of anchors extend radially outward via a first bend in a direction more perpendicular to the longitudinal axis of the frame body, and subsequently extend via a second bend in a direction more parallel to the longitudinal axis of the frame body.

55. The prosthesis of claim 52, wherein the ends of the plurality of lower anchors are spaced apart from and radially outward from the frame body.

56. The prosthesis of claim 55, wherein, in the expanded configuration, the plurality of lower anchors extend radially from the outer surface of the frame body by a distance equal to 120% or more of the diameter of the frame body.

57. The prosthesis of claim 52, wherein the tips of at least some of the plurality of lower anchors are covered with pads.

58. The prosthesis of claim 52, further comprising a lining that extends at least a portion of the length of the frame body.

59. The prosthesis according to claim 52, further comprising a valve body positioned within the frame body, the valve body comprising a plurality of prosthetic valve leaflets.

60. The prosthesis of claim 52, wherein the plurality of lower anchors are sized to capture the natural leaflets of a natural heart valve between the lower anchors and the frame body.

61. A replacement heart valve prosthesis, the prosthesis comprising: A self-expanding frame configured to radially expand and contract between a compression configuration and an expansion configuration for deployment within a natural heart valve, the self-expanding frame comprising: An inner frame, comprising an upper region, a middle region, and a lower region, having an generally cylindrical shape and a plurality of anchoring struts configured to extend downward in the compressed configuration of the self-expanding frame and to flip from the downward direction to a second direction extending radially outward toward the upper region when the self-expanding frame is in the expanded configuration. An outer frame, the outer frame including an outer frame body having an upper region, a middle region and a lower region, the outer frame being positioned radially outside the inner frame such that at least a gap exists between the upper region of the inner frame and the upper region of the outer frame. A covering configured to close the gap between the upper region of the inner frame and the upper region of the outer frame. The outer frame body has a D-shaped cross-section. In the expanded configuration, the upper region of the outer frame has a larger expanded shape than the lower region, and the middle region has a generally constant diameter to form an overall cylindrical shape. The outer frame body includes a plurality of pillars, wherein at least some of the pillars are forming units; and A valve body, positioned within the inner frame, the valve body comprising a plurality of leaflets configured to allow flow in one direction.

62. The prosthesis of claim 61, wherein the unit comprises multiple rows of units.

63. The prosthesis of claim 61, wherein the unit has a rhomboid or generally rhomboid shape.

64. The prosthesis of claim 61, wherein the unit has a rounded polygonal shape.

65. The prosthesis of claim 61, wherein the unit has an elliptical shape.

66. The prosthesis of claim 61, wherein the leaflet comprises a flexible leaflet made of pericardium.

67. The prosthesis of claim 61, wherein the outer frame includes barbs to facilitate anchoring.

68. The prosthesis of claim 67, wherein the barbs are angled upwards, angled downwards, or vertical.

Images