Transcatheter heart valve with improved blood flow

Abstract

A prosthetic heart valve includes three prosthetic valve leaflets coupled together at three commissure regions to form a central flow path. A collapsible and expandable valve frame for supporting the prosthetic valve leaflets is provided. The valve frame includes three cantilevered support arms for supporting the three commissure regions, and gaps are provided between the three cantilevered support arms for improving leaflet engagement and reducing thrombosis. The valve frame is positioned within an outer sealing frame, and the sealing frame is anchored to surrounding heart tissue. The prosthetic heart valve is adapted to be delivered using minimally invasive transcatheter surgery. The prosthetic heart valve is preferably used to replace a native mitral or tricuspid valve.

Description

[0001] Cross-references to related applications This application claims the benefits of U.S. Provisional Application No. 63 / 470,097, filed May 31, 2023, and U.S. Provisional Application No. 63 / 470,729, filed June 2, 2023, the entire contents of each of which are incorporated herein by reference. Background of the Invention Technical Field

[0002] Some of the examples disclosed herein involve implants in general, including prosthetic valves used for implantation. Background Technology

[0003] The human heart valves, including the aortic, pulmonary, mitral, and tricuspid valves, function essentially like one-way valves that work 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 narrowing or backflow, which inhibits the valve's ability to control blood flow. Such damage reduces the heart's pumping efficiency and can lead to debilitating and life-threatening conditions. For example, valvular insufficiency can cause conditions such as cardiac hypertrophy and ventricular dilatation. Therefore, considerable effort has been made to develop 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 autologous heart valves. Recently, significant efforts have been devoted to developing replacement heart valves, particularly tissue-based replacement heart valves, which can be delivered with less trauma to the patient than through open-heart surgery. Replacement valves are designed for delivery via minimally invasive surgery 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 block blood flow. However, problems can arise when blood stagnates within or around the replacement valve. For example, stagnation can lead to blood clots or other conditions that could result in a stroke or damage to the replacement valve, among other undesirable outcomes.

[0006] Furthermore, problems arise when blood flows around the valve outside the prosthesis. For example, perivalvular leakage (PVL) has proven particularly challenging in the case of heart valve replacement, potentially requiring further intervention in extreme cases. An additional challenge involves the ability of such prostheses to be secured relative to intraluminal tissues (such as any internal lumen or tissue within a body cavity) in a way that prevents damage. Moreover, another unintended consequence of this minimally invasive heart valve replacement, in order to secure it to intraluminal tissues, is that it is fixed within the heart without interfering with the heart's natural conduction system. Summary of the Invention

[0007] Examples of prosthetic valves involve improved blood flow. Improved blood flow leads to a reduction in thrombosis or other diseases associated with prosthetic valves. Examples include foldable or expandable prosthetic valves configured for transcatheter delivery to the implantation site.

[0008] Examples preferably include a valve frame that mimics the structure of a surgical valve (e.g., a surgical ring) and a sealing frame for anchoring and sealing. Such a combination of features allows for greater physiological flow behavior, thereby reducing the need for continuous anticoagulation therapy.

[0009] Examples of prosthetic valves may involve improvements in flow control at the implantation site and / or at the sealing of the implantation site, which may include a natural valve. Examples may be configured to conform to the shape of a natural valve, which may be non-circular. Examples may involve the configuration of prosthetic valve leaflets configured to reduce fluid stagnation in the neosinus space.

[0010] Various aspects of this disclosure include a prosthetic valve for deployment in a natural mitral or tricuspid valve. The prosthetic valve includes three prosthetic leaflets positioned around a flow channel of the prosthetic valve, the three leaflets being attached to form three commissural regions. The prosthetic valve includes a valve frame for supporting the prosthetic leaflets, wherein the valve frame is radially expandable from a compression configuration to an expansion configuration, the valve frame including three cantilevered support arms extending in an axial direction for supporting the three commissural regions, wherein three openings are provided between the three cantilevered support arms to reduce thrombus formation and improve leaflet fusion. The prosthetic valve includes an external sealing frame positioned radially lateral to the valve frame, wherein the sealing frame engages the natural mitral or tricuspid valve.

[0011] Aspects of this disclosure may include a prosthetic heart valve for deployment in a natural valve. The prosthetic heart valve may include a plurality of prosthetic valve leaflets. The prosthetic heart valve may include an inner frame supporting the plurality of prosthetic valve leaflets and having proximal and distal portions. The prosthetic heart valve may include a plurality of anchors positioned at the distal portion of the inner frame and adapted to capture the leaflets of the natural valve. The prosthetic heart valve may include a sealing body positioned radially outward from the inner frame and having a proximal end and a distal end coupled to the distal portion of the inner frame such that the sealing body is adapted to move relative to the inner frame. The prosthetic heart valve may include one or more clamping features positioned on the sealing body and adapted to engage a portion of the natural valve.

[0012] Aspects of this disclosure may include a prosthetic heart valve for deployment in a natural heart valve. The prosthetic heart valve may include a valve body. The prosthetic heart valve may include a plurality of prosthetic valve leaflets connected to the valve body, each of the plurality of prosthetic valve leaflets including: an outflow edge, a first lateral commissure end, a second lateral commissure end positioned opposite the first lateral commissure end, a central portion positioned between the first lateral commissure end and the second lateral commissure end, and an inflow edge positioned opposite the outflow edge, the inflow edge including at least one notch toward the central portion. Attached Figure Description

[0013] Referring to the specification, claims, and drawings, the features and advantages of the systems, apparatus, and methods disclosed herein will be better understood, wherein: Figure 1 An example is shown: a perspective view of the prosthetic valve as seen from the outflow side of the prosthetic valve.

[0014] Figure 2 Examples are shown from Figure 1 The positioning rotation shown is from the positioning point. Figure 1 A perspective view of the outflow side of the prosthetic valve.

[0015] Figure 3 Examples Figure 1 The image shows a view of the outflow end of the prosthetic valve.

[0016] Figure 4 Examples Figure 1 The side view of the prosthetic valve shown.

[0017] Figure 5 An example is shown from the inflow side of the prosthetic valve. Figure 1 The perspective view of the prosthetic valve shown.

[0018] Figure 6 Examples Figure 1 The diagram shows a side view of the prosthetic valve.

[0019] Figure 7 Examples Figure 1 The diagram shows the outflow end of the prosthetic valve.

[0020] Figure 8 An example is shown from the outflow side of the prosthetic valve. Figure 1 The diagram shows a perspective view of the prosthetic valve.

[0021] Figure 9 Examples Figure 1 A perspective view of the support arm of the prosthetic valve shown.

[0022] Figure 10 A perspective view of the support arm strut is shown.

[0023] Figure 11 The example shows a perspective view of two support arm pillars.

[0024] Figure 12 A side view of the sealing frame is shown.

[0025] Figure 13 A schematic diagram illustrating a delivery system near the implantation site is shown.

[0026] Figure 14 A cross-sectional schematic diagram of a delivery system near the implantation site is shown.

[0027] Figure 15 A schematic cross-sectional view of a prosthetic valve deployed onto a natural valve is shown.

[0028] Figure 16 A schematic cross-sectional view of a prosthetic valve deployed onto a natural valve is shown.

[0029] Figure 17 A schematic cross-sectional view of a prosthetic valve deployed onto a natural valve is shown.

[0030] Figure 18 A schematic cross-sectional view of a prosthetic valve deployed onto a natural valve is shown.

[0031] Figure 19 A schematic diagram of the outflow end of a prosthetic valve is shown.

[0032] Figure 20 Examples Figure 19 The diagram shows a perspective view of the prosthetic valve.

[0033] Figure 21 An inflow perspective view of the framework of a prosthetic valve is shown.

[0034] Figure 22 Examples Figure 21 The side view of the frame shown.

[0035] Figure 23 Examples Figure 21 The side view of the frame shown.

[0036] Figure 24 Examples Figure 21 The side view of the frame shown.

[0037] Figure 25 Examples Figure 21 The outflow perspective of the frame shown.

[0038] Figure 26 A schematic diagram of a side cross-section of a prosthetic valve is shown.

[0039] Figure 27 A cross-sectional schematic diagram of a delivery system near the implantation site is shown.

[0040] Figure 28 Examples of deployment to natural valves are shown. Figure 26 The diagram shows a cross-sectional view of the prosthetic valve.

[0041] Figure 29 An example of a perspective view of a prosthetic valve is shown.

[0042] Figure 30 Examples Figure 29 The top perspective view of the prosthetic valve shown.

[0043] Figure 31 Examples Figure 29 The diagram shows a cross-sectional view of the prosthetic valve.

[0044] Figure 32 Examples Figure 29 The diagram shows a cross-sectional view of the prosthetic valve.

[0045] Figure 33 Examples Figure 29 The diagram shows a cross-sectional view of the prosthetic valve.

[0046] Figure 34 A perspective view of a frame used for a prosthetic valve is shown.

[0047] Figure 35 A detailed perspective view of the anchors positioned relative to the prosthetic valve frame is shown.

[0048] Figure 36 A detailed side view of the anchors for frame positioning relative to the prosthetic valve is shown.

[0049] Figure 37 A schematic cross-sectional side view of an anchor that presses a natural valve leaflet against a frame is shown.

[0050] Figure 38A schematic cross-sectional side view illustrating the clamping features of the natural valve leaflet is shown.

[0051] Figure 39 A schematic cross-sectional side view illustrating the clamping features of the natural valve leaflet is shown.

[0052] Figure 40 A schematic diagram illustrating a delivery system near the implantation site is shown.

[0053] Figure 41 Examples of deployment to the implantation site are shown. Figure 29 The diagram shows a side view of the prosthetic valve.

[0054] Figure 42 An example of a perspective view of a prosthetic valve is shown.

[0055] Figure 43 Examples Figure 42 The diagram shows a cross-sectional view of the prosthetic valve.

[0056] Figure 44 A schematic cross-sectional view of a prosthetic valve is shown.

[0057] Figure 45 A schematic cross-sectional view of a prosthetic valve is shown.

[0058] Figure 46 A schematic cross-sectional view of a prosthetic valve is shown.

[0059] Figure 47 A plan view of a prosthetic valve leaflet is shown.

[0060] Figure 48 A perspective view of three prosthetic valve leaflets is shown.

[0061] Figure 49 A schematic cross-sectional view of a prosthetic valve is shown.

[0062] Figure 50 A schematic cross-sectional view of a portion of a prosthetic valve is shown. Detailed Implementation

[0063] Figure 1 A perspective view of a prosthetic valve 10 in the form of a replacement heart valve is illustrated. The prosthetic valve 10 is configured to be deployed within a part of a patient's body. For example, the prosthetic valve 10 is configured to be deployed into the annulus of a natural valve, which may include a natural mitral valve or a natural tricuspid valve. In this example, other implantation sites may be utilized as needed, such as within the aortic or pulmonary valve, or in other valves or locations within the patient's body.

[0064] The prosthetic valve 10 includes a proximal end 12 (in Figure 4The proximal end 12 (marked in the middle) and the distal end 14, and the length between them. The proximal end 12 includes the inflow end of the prosthetic valve 10, and the distal end 14 includes the outflow end of the prosthetic valve 10. The prosthetic valve 10 includes a plurality of prosthetic valve leaflets 16 (e.g., three prosthetic valve leaflets) configured to surround the flow channel 13 to control flow through the valve 10. The prosthetic valve leaflets 16 are configured to move between an open state and a closed state to mimic and replace the operation of natural valve leaflets.

[0065] The prosthetic valve leaflet 16 has multiple commissures. For example, as... Figure 1 As shown, three commissures 26a, b, c or commissure regions may exist between the corresponding prosthetic valve leaflets 16a, b, c. Leaflets 16 are attached to form three commissures 26a, b, c or commissure regions. Commissure 26a is positioned between the corresponding prosthetic valve leaflets 16a, b. Commissure 26b is positioned between the corresponding prosthetic valve leaflets 16b, c. Commissure 26c is positioned between the corresponding prosthetic valve leaflets 16c, a. In this example, commissures 26a, b, c may be equally spaced from each other, or other spacing may be used. In examples using a smaller number of prosthetic valve leaflets, a smaller number of commissures may be used. For example, two commissures may exist for two prosthetic valve leaflets. A larger number of commissures can be used for a larger number of prosthetic valve leaflets.

[0066] In this example, the prosthetic valve 10 includes a frame 18. In this example, the frame 18 may include a dual-frame or multi-component frame. In this example, the frame 18 includes, for example, a valve frame 20 and a sealing frame 22. Other configurations may be used in this example.

[0067] The valve frame 20 is configured to support multiple prosthetic valve leaflets 16. The valve frame 20 is radially expandable from a compression configuration to an expansion configuration. The valve frame 20 is radially compressible from an expansion configuration to a compression configuration. The expansion configuration is... Figure 1 As shown in the figure, but a compression configuration can be used (in Figure 14 (as indicated in the image). The compression configuration is used to deliver the prosthetic valve 10 via a catheter to the implantation site.

[0068] In this example, the valve frame 20 includes one or more support arms. The support arms may include a first support arm 24a that extends axially and is configured to support at least two of the plurality of prosthetic valve leaflets 16 (prosthetic valve leaflets 16a, b) at a first juncture 26a or juncture region. The support arms may include a second support arm 24b that extends axially and is configured to support at least two of the plurality of prosthetic valve leaflets 16 (prosthetic valve leaflets 16b, c) at a second juncture 26b or juncture region. In this example, a third support arm 24c extends axially and is configured to support at least two of the plurality of prosthetic valve leaflets 16 (prosthetic valve leaflets 16c, a) at a third juncture 26c or juncture region. In this example, the support arms 24a, b, and c may include cantilever support arms. The support arms 24a, b, and c extend in the axial direction.

[0069] In this example, each of the support arms 24a, b, and c is circumferentially spaced equidistant from each other. Other spacing may be used in this example.

[0070] An opening 28a is circumferentially positioned between the first support arm 24a and the second support arm 24b and is configured to allow blood flow through it. For example, opening 28a includes a space between the first support arm 24a and the second support arm 24b that can be extended from the first support arm 24a to the second support arm 24b. Opening 28a includes a flow channel for blood flow. In an example, opening 28a may have a "U" shape (e.g., Figure 1 and Figure 2 (as shown), or can have other configurations as needed.

[0071] Opening 28b is located between support arms 24b and c. Opening 28c is located between support arms 24c and a. Openings 28b and c can be constructed similarly to opening 28a in the example. Opening 28b can cross from the second support arm 24b to the third support arm 24c. Opening 28c can cross from the third support arm 24c to the first support arm 24a. Three openings 28a, b, and c are provided between support arms 24a, b, and c. The three openings 28a, b, and c reduce thrombus formation and improve lobule junction. Openings 28a, b, and c are substantially unobstructed to allow improved blood flow through them.

[0072] Each prosthetic valve leaflet 16a, b, c includes a central portion 30 located between a first commissural portion 32 and a second commissural portion 34. The first commissural portion 32 is located at a corresponding commissural portion of an adjacent prosthetic valve leaflet. The second commissural portion 34 is located at a corresponding opposing commissural portion of an adjacent prosthetic valve leaflet.

[0073] In this example, the corresponding opening 28a is circumferentially aligned with the central portion 30 of the prosthetic valve leaflet 16b. This positioning allows blood to flow from the radially outward-facing surface of the prosthetic valve leaflet through the corresponding opening (e.g., opening 28a). Flushing and leaflet engagement are thus improved.

[0074] Each support arm 24a, b, c can extend axially in the outflow direction to its corresponding free end 33a, b, c. The free ends 33a, b, c can include the ends of the respective support arms 24a, b, c. In this example, the ends 33a, b, c of the support arms 24a, b, c can be free and not directly connected to each other. In this example, a connection is utilized between the ends 33a, b, c.

[0075] In this example, each support arm 24a, b, c includes one or more support arm struts. For instance, support arm 24a may include three support arm struts 36a, b, c. Support arm strut 36a includes an axially extending central strut. Support arm struts 36a are circumferentially positioned between adjacent support arm struts 36b, c. Figure 9 A perspective view of the support arm 24a is shown. The support arm strut 36a includes an outwardly curled strut for resisting inward bending of the support arm 24a. The support arm strut 36a is shown as having a radially outwardly curled portion 38. The distal end 37 of the support arm strut 36a includes a connector 40 for engagement with the junction 26a of the prosthetic valve leaflets 16a, b. The proximal end of the support arm strut 36a includes a connector 42 for engagement with a portion of the delivery system for the prosthetic valve. In this example, the connector 42 is configured for engagement with a portion of the sealing frame 22.

[0076] The coiled portion 38 of the support arm strut 36a is coiled to resist loads (e.g., contractile loads) applied to the prosthetic valve 10 and valve frame 20 at the junction of the prosthetic valve leaflet 16. The curvature of the coiled portion 38 resists loads on the prosthetic valve 10 and valve frame 20 that pull on the cantilever support arm 24a at the junction. The coiled portion 38 includes a curved portion. The shape of the coiled or curved portion can be adjusted as needed (e.g., strengthened or reduced) to change the resistance to loads. By providing a radially outward curvature or bend, the moment of inertia of the support arm 24a can be set to resist radially inward bending. In the example, the resulting support arms 24a, b, and c can be flexible in the radial direction.

[0077] The support arm strut 36a resists forces applied to the prosthetic valve 10 and valve frame 20 via its connection to the sealing frame 22. The proximal end of the support arm strut 36a includes an inflow support structure that maintains the inflow of the prosthetic valve 10 in a circular manner. A connector 42 at the prosthetic valve is connected, for example, at the proximal end 46 of the sealing frame 22 to a connector 59 (e.g., ...). Figure 4 and Figure 12 (as marked in the diagram) to form an inflow support structure that maintains the inflow of the prosthetic valve 10 in a circular manner. The support arm strut 36a extends axially and is circumferentially aligned with the corresponding commissure or commissure region of the prosthetic valve leaflet.

[0078] Support arm struts 36b and c are angled toward the central support arm strut 36a. Support arm struts 36b and c comprise a single body for attachment to the distal end 37 of the support arm strut 36a, or in some instances, an alternative configuration may be used. Support arm struts 36b and c are angled toward the central support arm strut 36a in the direction toward the distal end of the central support arm strut 36a.

[0079] The support arm struts 36b and c include, at their distal ends, connectors 41 for connection to the junction 26a of the prosthetic valve leaflets 16a and 16b in a manner similar to that of connector 40. In an example, the support arm struts 36b and 36c include corresponding connectors 43a and 43b at their proximal ends for connection to a portion of the delivery system or to a portion of the sealing frame 22.

[0080] The support arm struts 36b and c are angled toward the central support arm strut 36a to form spaces 45a and b circumferentially spaced from the central support arm strut 36a. In some examples, spaces 45a and b are triangular or wedge-shaped. Spaces 45a and b allow the support arm struts 36b and c to fold toward the central support arm strut 36a in a folded configuration. This feature allows the valve frame 20 to move toward the folded configuration. When the valve frame 20 moves toward the expansion configuration, the support arm struts 36b and c can deflect outward away from the central support arm strut 36a.

[0081] In this example, the support arm struts 36a, b, and c can be made of a self-expanding material. Self-expanding materials may include nitinol or other forms of self-expanding materials. Figure 9 As shown, the support arm struts 36a, b, and c comprise multiple thin layers of a self-expanding material (e.g., nitinol) stacked on top of each other. Other configurations may be used in this example.

[0082] Figure 10 A separate view of a central support arm strut 35a is shown, which can be used in a similar manner to the support arm strut 36a. Figure 11Separate views of angled support arms 35b and c are shown, which can be used in a similar manner to support arm struts 36b and c. In the examples, support arm struts 36b and c have a "Y" configuration or other bifurcated configurations as required.

[0083] In this example, other configurations of the support arms can be used. Each of the support arms 24a, b, and c can be constructed similarly to each other, or in this example, can have other configurations.

[0084] In this example, support arms 24a, b, and c can be circumferentially separated from each other and are not directly connected to one another. Direct connection could be used in this example.

[0085] refer to Figure 1 The sealing frame 22 is configured to seal and engage with the natural valve. The sealing frame 22 includes an outer sealing frame 22 surrounding the valve frame 20 and positioned radially outward of the valve frame 20. The sealing frame 22 is configured to contact a portion of the natural valve (e.g., a natural valve leaflet or natural valve annulus) to seal with that portion of the natural valve. In an example, a sealing skirt 39 is positioned on the sealing frame 22. The sealing frame 22 may include a portion of a sealing body for sealing with a portion of the natural valve. The sealing body may include a combination of the sealing frame 22 and the sealing skirt 39. Other configurations may be utilized in the examples. The outer surface 47 of the sealing body may contact a portion of the natural valve to seal with it. In an example, the sealing skirt 39 may include a fabric sealing skirt. The sealing skirt 39 may be positioned on a large portion of the sealing frame 22.

[0086] The sealing frame 22 can expand radially outward from a compression configuration to an expansion configuration. The sealing frame 22 can also compress radially inward from an expansion configuration to a compression configuration. The sealing frame 22 may include, for example, a mesh structure comprising struts 49 and openings 51, or a strut mesh comprising compressible and expandable structures. The mesh structure is configured such that the length of the sealing frame 22 increases as the diameter of the sealing frame 22 decreases during compression. When expanded to the expansion configuration, the length of the sealing frame 22 decreases as the diameter of the sealing frame 22 increases. Figure 12 An isolated side view of the sealing frame 22 is shown.

[0087] refer to Figure 4The sealing frame 22 includes a proximal portion 53 (or inflow portion), a distal portion 55 (or outflow portion), and a coiled portion 57 positioned between the proximal portion 53 and the distal portion 55. The proximal portion 53 projects radially outward from the proximal end 46 (or inflow end or inflow portion) of the sealing frame 22. The sealing frame 22 projects radially outward from the valve frame 20. The distal portion 55 extends in a distal direction. The coiled portion 57 is coiled such that the distal portion 55 is angled relative to the proximal portion 53. The proximal portion 53 of the sealing frame 22 is coupled to the proximal portion of the valve frame 20.

[0088] The proximal end 46 of the sealing frame 22 includes one or more connectors 59 for connection with connectors 42, 43a, b of the support arm, such as... Figure 9 As shown. This connection forms a link between the sealing frame 22 and the valve frame 20. Other forms of connection may be used in this example. In this example, the connector 59 may be used to connect to a part of the delivery system. For example, the connector 59 may include an eyelet or other form of connector for connection to a suture or other connection body of the delivery system. Other forms of connection may be used in this example.

[0089] Connector 59 is positioned near the tip of the support post 49 of the sealing frame 22. The corresponding connector 59 is connected to a corresponding connector among the connectors 42, 43a, and 43b of the support arm. For example, in Figure 1 The example shown uses nine support arm struts. Nine corresponding connectors 59 can be used (e.g., as...). Figure 4 (As shown). The connectors 59 are circumferentially spaced apart from each other, wherein adjacent groups of connectors 59 (e.g., groups of three connectors) are used for corresponding support arms 24a, b, c.

[0090] refer to Figure 1 A sealing frame 22 surrounds the valve frame 20. The sealing frame 22 may surround, for example, a first support arm 24a and a second support arm 24b. In an example utilizing a third support arm 24c, the sealing frame 22 may surround the third support arm 24c. In some examples, the outlet end of the sealing frame 22 may be positioned further downstream than the outlet end of the valve frame 20.

[0091] The sealing frame 22 is spaced apart from the valve frame 20 by a notch 48. The notch 48 forms a ring extending around the valve frame 20 and having an annular shape. The notch 48 includes a spacer with respect to the valve frame 20, which allows blood flow through it. The inner surface 61 of the sealing frame 22 faces the notch 48. The outlet end of the valve frame 20 is radially spaced from the outlet end of the sealing frame 22 to provide the notch 48 between them. The outlet end of the valve frame 20 does not contact the outlet end of the sealing frame 22 and provides a gap between them.

[0092] The distal portion 55 or outlet portion of the sealing frame 22 is spaced apart from the valve frame 20 to form an opening 50 for the interior of the sealing frame 22. The interior of the sealing frame 22 includes a notch 48 or an annular ring extending around the valve frame 20. Thus, blood can flow through the opening 50 and within the notch 48. The sealing frame 22 has a concave shape facing the ventricle when deployed to direct blood towards the valve frame 20 and the prosthetic valve leaflet 16.

[0093] Figure 2 Examples are given from Figure 1 A perspective view of the positioned and rotated prosthetic valve 10 shown. Figure 3 An example is shown: a view of the distal end or the outflow end of the prosthetic valve 10. Figure 4 A side view of the prosthetic valve 10 is shown. Figure 5 An example is shown: a proximal end view or an inflow end view of the prosthetic valve 10.

[0094] Figure 6 A schematic representation of the prosthetic valve 10 is shown. Figure 7 A schematic distal end view or outflow end view of the prosthetic valve 10 is shown.

[0095] refer to Figure 8 The openings 28a, b, c between adjacent support arms 24a, b, c allow blood flow to pass through them, thereby reducing the incidence of stagnant blood flow radially outwards in the prosthetic valve leaflets 16a, b, c. Figure 8 As indicated by flow arrow 52, ​​blood flows radially outward along the prosthetic valve leaflets 16a, b, c through the corresponding openings 28a, b, c. Openings 28a, b, c provide flow channels for blood. Blood flows through and exits the notch 48 located between the valve frame 20 and the sealing frame 22. The sealing frame 22 preferably has a smooth inner surface that, when the prosthetic valve leaflets are in the closed position, alters the flow direction and facilitates complete flushing.

[0096] The reduced incidence of stagnant blood flow can decrease the formation of thrombi or other diseases within the radially outward gap 48 of the leaflet 16 or the sealing frame 22, thus improving hemodynamic outcomes. Furthermore, the prosthetic valve 10 is foldable or expandable to allow for transcatheter delivery.

[0097] The valve frame 20 mimics the structure of a surgical valve (e.g., a surgical ring). The sealing frame 22 provides anchorage and sealing. This combination of features allows for greater physiological flow behavior, thus reducing the need for continuous anticoagulation therapy. It mimics the low thrombotic benefits of bioprosthetic surgical valves. The prosthetic valve leaflet 16 is suspended in free space (rather than being covered by a cylindrical structure). This type of structure reduces the likelihood of thrombosis due to the open flow channels between the support arms 24a, b, and c. The shape of the sealing frame 22 reduces the incidence of turbulence or coagulation and allows for flushing during the opening and closing of the prosthetic valve leaflet.

[0098] In the example, one or more anchors 54 (in) Figure 15 (The part marked in the image) is used to anchor the prosthetic valve 10 to the implantation site. For example, see reference... Figure 15 Anchor 54 includes a coiled elongated anchor or hook configured to hook around the natural leaflet 56 for positioning radially outward of the natural leaflet 56. The anchor is shaped to extend above the distal tip of the natural leaflet 56 of the natural valve 58. In an example, anchor 54 may extend from valve frame 20. For example, in an example, anchor 54 may extend from a corresponding support arm of support arms 24a, b, c. In an example, anchor 54 may extend from other portions of prosthetic valve 10. Anchor 54 is adapted to capture the natural leaflet between anchor 54 and sealing frame 22. Anchor 54 is adapted to bend from an elongated configuration to a hook-shaped, coiled, or bent configuration during deployment, such as... Figure 15 As shown.

[0099] Figures 13 to 15 An exemplary deployment procedure for the prosthetic valve 10 is illustrated. (Reference) Figure 13 The delivery device 60 can be accessed at the implantation site via a channel through the patient's vascular system. In this example, it can be deployed via a catheter. In this example, the delivery device 60 can be delivered via the femoral vein 62 or via another delivery method.

[0100] The delivery device 60 can be accessed via a vein to the implantation site. For example, the delivery device 60 can access the right atrium 63 to deploy to the tricuspid valve. In an example, the delivery device 60 can pass through the septum to reach the left atrium 65 to deploy to the mitral valve. Figure 13 Advancement towards the mitral valve is illustrated, but advancement towards the tricuspid valve can also be used. In this example, other methods can be used for other implantation sites.

[0101] refer to Figure 14 In this example, the prosthetic valve 10 is held in a compression configuration within the delivery device 60. For example, a sac 64 or other form of retainer can hold the prosthetic valve 10 in a compression configuration. The prosthetic valve 10 may include a self-expanding prosthetic valve 10 that expands upon release by a retainer such as sac 64. The frame 18 of the prosthetic valve 10 (including a valve frame 20 and a sealing frame 22) is self-expanding. The frame 18 may be made of a shape memory material that produces self-expansion. In this example, the shape memory material may be nitinol or another form of shape memory material.

[0102] In this example, the prosthetic valve 10 may be configured for delivery together with an inflatable body, such as a balloon or other deployment configuration. The inflatable body is positioned inside the prosthetic valve 10 and inflates to expand the prosthetic valve 10 into an expanded configuration.

[0103] Figure 14 An example is illustrated of a prosthetic valve 10 in a compression and elongation configuration, wherein the anchor 54 and sealing frame 22 are elongated and have a diameter reduced from the deployment configuration. The sac 64 can retract to release the prosthetic valve 10 from the compression configuration, or other forms of deployment may be utilized in the example.

[0104] Figure 15 An example of a deployed prosthetic valve 10 is shown. Anchors 54 are hooked above the natural valve leaflet 56. For example, as... Figure 8 As shown, this allows blood flow through the corresponding openings 28a, b, and c, improving hemodynamic outcomes.

[0105] Other forms of prosthetic valves may be used in the examples. Other forms of anchorage may be used in the examples.

[0106] For example, Figure 16 A variation of the prosthetic valve 10 is illustrated, wherein the anchor 66 extends from the sealing frame 22. The valve frame 20 does not have anchors directly connected to it, and therefore can therefore have, for example, as... Figure 1 The appearance shown.

[0107] Figure 17 One variation is illustrated in which one or more anchors 68 include barbs extending radially outward from the sealing frame 22. The anchors 68 are positioned on the sealing frame 22 (e.g., the outer surface of the sealing frame 22) or may be positioned on the valve frame 20, and may extend radially outward from the valve frame 20 and through the sealing frame 22. The anchors 68 enhance the anchorage to the natural valve.

[0108] Figure 18One variation is illustrated in which the sealing frame 22 forms one or more flanges 70, 72 for anchoring the prosthetic valve to the natural valve. A proximal or atrial flange 70 may be used, and a distal or ventricular flange 72 may be used. A recess 74 is formed between the proximal or atrial flange 70 and the distal or ventricular flange 72 to retain a portion of the natural valve for anchoring. In this example, the sealing frame 22 may have an hourglass shape or other shapes.

[0109] Other variations of the prosthetic valve 10 can be provided. For example, Figure 19 A variation is illustrated in which one or more flow barriers 80 are positioned within a notch 48. The flow barriers 80 are circumferentially spaced apart from each other and positioned radially outward of a corresponding support arm of support arms 24a, b, c. The flow barriers 80 extend radially outward from a corresponding support arm of support arms 24a, b, c to the sealing frame 22. In this example, the flow barriers 80 extend radially outward from the central support arm post 36a (e.g., as shown in the image). Figure 9 (As indicated in the diagram). The flow barrier 80 is coupled to the central support arm strut 36a and extends radially outward to the sealing frame 22. In this example, the flow barrier 80 may cover the curled portion 38 of the support arm strut 36a, or other configurations may be utilized. Three flow barriers 80 may be provided, but fewer or more may be used as needed.

[0110] The flow barrier 80 is positioned to reduce the likelihood of blood stagnation radially outward from the corresponding support arm 24a, b, c. The formation of the notch 48 around a portion of the annular portion of the valve frame 20 allows blood flow through the flow barriers 80. Three discrete zones are provided within the sealing frame 22 to improve flushing. The flow barrier 80 may be wedge-shaped or conical, as... Figure 19 and Figure 20 As shown. The width of the wedge or cone shape increases in the radially outward direction. Other shapes can be used in the examples as needed.

[0111] Figures 1 to 20 The features can be used alone or in combination with any other instance in this article.

[0112] In practice, various other configurations of prosthetic valves can be utilized.

[0113] For example, Figure 21An illustration shows a frame configuration for a prosthetic valve, wherein a valve frame 90 holds the prosthetic valve leaflet 92 under the annulus. The valve frame 90 may be constructed similarly to valve frame 20 and includes a plurality of axially extending support arms 94a, b, c. Support arms 94a, b, c are positioned at the juncture or juncture region of adjacent prosthetic valve leaflets 92. Openings 95a, b, c are positioned between corresponding adjacent support arms 94a, b, c. In an example, support arms 94a, b, c may comprise cantilevered support arms. Support arms 94a, b, c extend axially to support the juncture region of adjacent prosthetic valve leaflets 92. Support arms 94a, b, c support the juncture region of the prosthetic valve leaflet 92. Openings 95a, b, c are positioned between corresponding adjacent support arms 94a, b, c to reduce thrombosis and improve leaflet fusion. Openings 95a, b, and c are essentially unobstructed to allow for improved blood flow through them.

[0114] Figure 23 Examples of the same Figure 21 The diagram shows a side view of the valve frame 90 on opposite sides. Support arms 94a, b, c are connected to connecting struts 97 extending along the inflow edge 99 of the respective prosthetic valve leaflet 92. The connecting struts 97 are angled to form a "Y" or fork shape between adjacent support arms 94a, b, c. The connecting struts 97 extend at the central portion of the openings 95a, b, c of the valve frame 90 to a connector 101, which can be used for connection to an anchoring frame 96.

[0115] In this example, the anchoring frame 96 includes a grid structure of supports 98 or a support mesh and openings 100. The anchoring frame 96 has, for example, a mesh structure of supports 98 or a support mesh and openings 100. Figure 21 The cylindrical shape shown may be used, or other shapes may be required. The anchoring frame 96 and the valve frame 90 may each be configured in a compression or expansion configuration. Delivery may be made via catheter.

[0116] In this example, the valve frame 90 is attached to the distal end portion 102 of the anchor frame 96. The anchor frame 96 is positioned along the inlet end of the prosthetic valve and is located at the inlet portion or inlet end of the valve frame 90. In this example, the anchor frame 96 can be modularly attached to the valve frame 90. The anchor frame 96 can be detached from the valve frame 90 as needed. Therefore, various other configurations of the valve frame and anchor frame can be used interchangeably as needed. Various combinations of the valve frame and anchor frame can be used to address the size or type of implantation site (e.g., mitral valve implantation versus tricuspid valve implantation). Different sized valve frames 90 can be modularly attached to the anchor frame 96 as needed. Different types of valve frames 90 can be modularly utilized (e.g., two prosthetic valve leaflets versus three prosthetic valve leaflets). For example, Figure 23The connector 101 shown includes eyelets that allow for stitching connections or other forms of modular connections to the anchoring frame 96.

[0117] In this example, one or more anchors 104 are coupled to and project radially outward from the anchor frame 96. Anchors 104 may include hooks or have another configuration as disclosed herein. Anchors 104 may be coiled elongated anchors and adapted to capture natural leaflets (in the space between the anchor 104 and the sealing frame 106) Figure 26 (Marked in the middle). Anchor 104 is adapted to bend from an elongated configuration to a hook-like, curled, or bent configuration during deployment, such as... Figure 28 As shown.

[0118] Anchor frame 96 can be used to bear anchor loads, rather than applying such anchor loads directly to valve frame 90. Anchor 104 moves the natural valve leaflet proximal to the atrium of the prosthetic valve leaflet to provide open space for blood flow.

[0119] Figure 22 A side view of the valve frame 90 connected to the anchor frame 96 is shown. Figure 23 A side view of valve frame 90 is shown. Figure 24 A side view of the anchor frame 96 is shown. Figure 25 An example is shown in the distal or outflow perspective view of the valve frame 90 connected to the anchor frame 96.

[0120] Anchor frame 96 is positioned to project from valve frame 90 in the inflow direction or proximal direction. Anchor frame 96 exposes openings 95a, b, c between support arms 94a, b, c to allow blood flow through them.

[0121] In this example, the sealing frame 106 is coupled to and surrounds the anchoring frame 96. The sealing frame 106 includes an outer sealing frame 106 positioned radially outward of the valve frame 90. Figure 26A representative positioning of the sealing frame 106 is illustrated. The sealing frame 106 can be constructed similarly to the sealing frame 22. The sealing frame 106 is configured to engage a natural valve. The proximal or inflow portion of the sealing frame 106 is connected to the proximal or inflow portion of the anchoring frame 96. The sealing frame 106 is positioned such that the distal end 108 of the valve frame 90 is positioned distal to the distal end 110 of the sealing frame 106. In this example, the outlet end of the valve frame 90 can be positioned further downstream than the outlet end of the sealing frame 106. Therefore, the openings 95a, b, c of the valve frame 90 are not covered by the sealing frame 106 to allow additional blood flow through the openings 95a, b, c. The openings 95a, b, c form blood flow pathways not covered by the sealing frame 106. The anchors 104 of the anchoring frame 96 are positioned proximal to the blood flow pathways of the openings 95a, b, c or along the inflow direction of the blood flow pathway. The prosthetic valve leaflet is positioned in an open space (rather than a closed structure) to improve blood flow. In this example, the sealing frame may include a sealing skirt, which may include a fabric sealing skirt or other form of skirt. The sealing skirt may be positioned on a large portion of the sealing frame 106.

[0122] The outlet end of the valve frame 90 is radially spaced from the outlet end of the sealing frame 106 to provide a gap between them. The outlet end of the valve frame 90 does not contact the outlet end of the sealing frame 106 and provides a gap between them.

[0123] Figure 27 and Figure 28 A representative configuration of the prosthetic valve during deployment is illustrated. Figure 27 An example is shown of a prosthetic valve in a compressed or undeployed configuration within the capsule of a delivery device. The prosthetic valve can be released from the capsule to position it in a deployment configuration, such as... Figure 28 As shown. The prosthetic valve may include a self-expanding prosthetic valve that expands upon release from a retaining body (such as a capsule). The frame of the prosthetic valve (including a valve frame 90, an anchoring frame 96, and a sealing frame 106) is self-expanding. The frame may be made of a shape memory material that produces self-expansion. In an example, the shape memory material may be nitinol or another form of shape memory material.

[0124] In some cases, the prosthetic valve may be configured for delivery along with an inflatable body, such as a balloon or other deployment configuration. The inflatable body is positioned inside the prosthetic valve and expands to expand the prosthetic valve into an expanded configuration.

[0125] The valve frame 90 can be positioned below the annulus and distal to the positioning of the anchor 104 and the sealing frame 106. After deployment, the valve frame 90 is positioned within the natural ventricle. Figure 21 and Figure 23The openings 95a, b, and c shown are not covered by the sealing frame 106 to allow blood flow through them, thereby reducing the incidence of blood stagnation. In this example, the positioning of the valve frame 90 can be varied to position the valve frame 90 relative to the natural valve on the annulus. For example, the valve frame 90 can be positioned at the proximal end portion or the inflow portion of the anchoring frame 96 for annular positioning. The openings 95a, b, and c comprise open flow channels not covered by the anchoring frame 96 and the sealing frame 106. The prosthetic valve leaflet is positioned in an open space (rather than a closed structure) to improve blood flow.

[0126] The valve frame 90 mimics the structure of a surgical valve (e.g., a surgical ring). A sealing frame 106 provides a seal, and an anchoring frame 96 provides anchorage. This combination of features allows for greater physiological flow behavior, thus reducing the need for continuous anticoagulation therapy. It mimics the low thrombotic benefits of bioprosthetic surgical valves. The prosthetic valve leaflet 92 is suspended in free space (rather than being covered by a cylindrical structure). This type of structure reduces the likelihood of thrombosis due to the open flow channels between the support arms 94a, b, and c. The positioning of the prosthetic valve leaflet 92 in the open space reduces the incidence of turbulence or coagulation outside the prosthetic valve leaflet 92.

[0127] Figures 21 to 28 The features can be used alone or in combination with any other instance in this article.

[0128] In practice, various other configurations of prosthetic valves can be utilized.

[0129] Figure 29 A perspective view of a prosthetic valve 210 in the form of a replacement heart valve is illustrated. The prosthetic valve 210 can be configured for deployment within a part of a patient's body. For example, the prosthetic valve 210 can be deployed to the annulus of a natural valve, which may include a natural mitral valve or a natural tricuspid valve. In examples, other implantation sites can be utilized as needed, such as within the aortic or pulmonary valve, or in other valves or locations within the patient's body.

[0130] The prosthetic valve 210 may include a proximal end 212 and a distal end 214 (in Figure 31 The prosthetic valve 210 may also include multiple prosthetic valve leaflets 216 (marked in the middle) and their lengths. Figure 30 (as marked in the image) Multiple prosthetic valve leaflets are configured to surround a flow channel 217 for controlling flow through valve 210. Prosthetic valve leaflets 216 can be configured to move between an open and closed state to mimic and replace the operation of natural valve leaflets.

[0131] In this example, the prosthetic valve leaflet 216 may be attached to a frame. The frame may include an inner frame 218 or a valve frame, and may include an outer frame 220, which may be part of the sealing body 211.

[0132] The inner frame 218, or valve frame, can support multiple prosthetic valve leaflets 216. The inner frame 218 may have a proximal portion 222 and a distal portion 224 (in... Figure 31 (marked in the middle), and can extend along the first axis 226. The inner frame 218 may include a skirt 228 connected thereto. The inner frame 218 may surround the flow channel 217.

[0133] In this example, the profile of the inner frame 218 allows the proximal portion 222 of the inner frame 218 to have a larger diameter than the distal portion 224 of the inner frame 218. The profile of the inner frame 218 can be radially outwardly curved along a direction from the distal portion 224 towards the proximal portion 222 (e.g., Figure 31 (As shown). The inner frame 218 can be curled, or it can utilize other configurations such that the proximal portion 222 has a larger diameter than the distal portion 224. In examples, other configurations of the inner frame 218 can be used. For example, the inner frame 218 can have a cylindrical shape with a uniform diameter from the proximal portion 222 to the distal portion 224, or it can have a curled profile shape, wherein the distal portion 224 has a larger diameter than the proximal portion 222. The proximal portion 222 of the inner frame 218 can flare radially outward along a direction from the distal portion 224 toward the proximal portion 222. In examples, other configurations of the inner frame can be used.

[0134] The prosthetic valve leaflet 216 can be attached to the inner frame 218. For example, the prosthetic valve leaflet 216 can be attached via a connecting line 230 or a suture that connects the prosthetic valve leaflet 216 to the skirt 228. In examples, the prosthetic valve leaflet 216 may have other forms of attachment.

[0135] Multiple anchors 232 may be positioned at the distal portion 224 of the inner frame 218 and may be configured to capture the leaflet of the natural valve. The anchors 232 may be specifically configured to anchor to the natural valve leaflet of the patient's heart. The anchors 232 may extend around the natural valve leaflet to anchor to it. The anchors 232 may be configured to be positioned radially lateral to the outward-facing surface 234 of the natural valve leaflet 236, for example... Figure 41 As shown. Anchor 232 may include a distal anchor located at the distal end 214 of valve 210, or in an example, may be located at another location as needed.

[0136] Anchors 232 may each extend radially outward from the flow channel 217 and radially outward from the prosthetic valve leaflet 216 of the valve 210. (Reference) Figure 31 Anchor 232 can be attached to the distal portion 224 of the inner frame 218. Anchor 232 may each include a proximal portion 238 and a distal portion 240, wherein the proximal portion 238 is attached to the inner frame 218, and the distal portion 240 includes the tip of the corresponding anchor 232. When the valve 210 is deployed, the anchor 232 can extend vertically and proximally from the proximal portion 238 to the tip at the distal portion 240.

[0137] like Figure 31 As shown, each anchor 232 is configured as a protruding arm that extends distally and then curls proximally to the tip of a corresponding anchor 232. This configuration allows the anchor 232 to extend around the natural leaflet and around its distal tip to hook around and retain the leaflet between the anchor 232 and the sealing body 211. The anchor 232 can be positioned radially lateral to the outward-facing surface of the natural valve leaflet. Therefore, the anchor 232 can resist forces applied to the valve 210 in the atrial or proximal direction and can anchor the valve 210 within the natural valve annulus. The anchor 232 can be configured to retain the natural leaflet between the anchor 232 and the sealing body 211. Other configurations of the anchor 232 may be utilized in this example as needed.

[0138] Anchor 232 in Figures 29 to 33 The diagram shows the anchor 232 in a deployed or expanded configuration, with the tip extending proximally. In examples, the anchor 232 can be configured in an undeployed, unexpanded, or linearized configuration, with the tip extending distally. During deployment, the anchor 232 can be configured to move radially outward from the undeployed configuration to the deployed configuration, with the tip flipped proximally. This operation allows the anchor 232 to flip over the natural valve leaflet during deployment to anchor to it. Other deployment methods for the anchor 232 can be utilized in the examples as needed.

[0139] The sealing body 211 can be radially outwardly positioned from the inner frame 218 and may have a proximal end 242 and a distal end 244, the distal end being coupled to a distal portion 224 of the inner frame 218, such that the sealing body 211 is configured to move relative to the inner frame 218. In an example, the prosthetic valve 210 may include one or more flexible bodies 246 that can couple the distal end 244 of the sealing body 211 to the distal portion 224 of the inner frame 218 and allow the sealing body 211 to move relative to the inner frame 218. One or more flexible bodies 246 may extend from the inner frame 218 to one or more connection points on the sealing body 211. In an example, the one or more flexible bodies 246 may be shaped like an arm, or may have another shape as needed. In an example, the one or more flexible bodies 246 may include fabric or shape memory material (such as nitinol), or may have another configuration as needed. The sealing body 211 and the inner frame 218 may lack direct coupling to each other. One or more flexible bodies 246 can connect the sealing body 211 to the inner frame 218.

[0140] In one example, one or more flexible bodies 246 may form a cover at the distal end of the notch 248 between the inner frame 218 and the sealing body 211. One or more flexible bodies 246 may close the distal end of the notch 248 between the sealing body 211 and the inner frame 218. For example, one or more flexible bodies 246 may form a ring positioned at the distal end 244 of the sealing body 211, connecting the distal end 244 of the sealing body 211 to the distal portion 224 of the inner frame 218. The annular ring may form a seal at the distal end 244 of the sealing body 211, preventing fluid from flowing through the one or more flexible bodies 246 into the notch 248.

[0141] The sealing body 211 may be configured to seal against a portion of a patient's heart valve. The sealing body 211 may include a frame (which may be an outer frame) 220 and a sealing skirt 250, but other configurations may be used as needed. The sealing body 211 may taper radially inward in a direction from the proximal end 242 toward the distal end 244, but other configurations may be used as needed. The proximal end portion of the sealing body 211 may flare radially outward in a direction from the distal end 244 toward the proximal end 242 of the sealing body. The sealing body 211 may extend about a second axis 252.

[0142] The sealing body 211 may be spaced apart from the inner frame 218 by a notch 248. In an example, the notch 248 may include an annular notch. The proximal end 242 of the sealing body 211 may form an opening for the notch 248. The notch 248 may close at the distal end 244 of the sealing body 211. For example, the flexible body 246 may include closure of the space between the distal end 244 of the sealing body 211 and the inner frame 218. In an example where the flexible body 246 includes a fabric material, the fabric material may form a seal at the distal end 244 of the sealing body 211.

[0143] The distal end 244 of the sealing body 211 can be coupled to the distal portion 224 of the inner frame 218, such that the sealing body 211 can be configured to move axially relative to the inner frame 218. For example, the sealing body 211 can move distally or proximally relative to the inner frame 218 along axis 226. In an example, the distal end 244 of the sealing body 211 can be coupled to the distal portion 224 of the inner frame 218, such that the sealing body 211 is configured to tilt relative to the inner frame 218 so that the first axis 226 is offset from the second axis 252.

[0144] For example, Figure 32 An example is illustrated where the sealing body 211 is tilted relative to the inner frame 218. In this example, either the sealing body 211 or the inner frame 218 may be tilted. In this example, the inner frame 218 may be tilted while the sealing body 211 remains stationary. Although the inner frame 218 is tilted, the sealing body is not tilted, thus maintaining optimal sealing. The second axis 252 is offset from the first axis 226. The flexible body 246 has been deflected to allow the sealing body 211 to move relative to the inner frame 218.

[0145] Figure 33 An example is illustrated of axial movement of the inner frame 218 relative to the sealing body 211. The sealing body 211 is shown moving proximally relative to the inner frame 218, wherein one or more flexible bodies 246 deflect to allow such movement. In this example, a combination of tilting and axial movement may be utilized.

[0146] This movement can be used to accommodate deployments where the chordae tendineae or papillary muscles or adjusting bands in the ventricle can be captured by the anchor 232 or another part of the prosthetic valve. Such an inner frame 218 can be tilted or axially moved to its captured position; however, the sealing body 211 can remain stationary and maintain optimal axis for preventing perivalvular leakage (PVL). This movement can provide additional benefits.

[0147] In this example, the prosthetic valve 210 may include one or more clamping features. These clamping features can take various forms. (See reference) Figure 34For example, clamping features 254, 256, and 258 can be positioned on the sealing body and can also be positioned on the outer frame 260 of the sealing body. Unless otherwise stated, features of the outer frame 220 can be used with the outer frame 260. Clamping features 254, 256, and 258 can be adapted to engage a portion of a natural valve.

[0148] The outer frame 260 may include a plurality of pillars 262 defining openings 264, 266 of the outer frame 260. In an example, the pillars 262 may form a grid configuration or a pillar grid. The pillars 262 may form closed units defining opening 264 or open units defining opening 266. For example, the pillars 262 may include pillars 262a–d that may define opening 264a. Opening 266 may not be defined by pillars on a portion of opening 266 (e.g., opening 266 may be at a distal portion of the outer frame 260 or may form the distalmost opening 266 of the outer frame 260). In an example, clamping features 254, 256, 258 may extend toward at least one of the plurality of openings 264, 266 of the outer frame 260.

[0149] In this example, opening 266 can be aligned circumferentially with one or more anchors in anchor 232. (See reference) Figure 35 For example, opening 266 may include opening 266a, which may be defined by posts 262a and 262e. Opening 266a may be circumferentially aligned with anchor 232, such that anchor 232 can be positioned at opening 266a. For example, Figure 36 An example of circumferential alignment of anchor 232 relative to opening 266a is shown. The tip of anchor 232 can be positioned at opening 266a.

[0150] Multiple struts 262 may include distal tips 263 that can flare out radially in an example.

[0151] In this example, clamping features 254 may include clamping features 254a, b that can be positioned at the location of anchor 232. Clamping features 254a, b may be configured to engage the surface of the natural valve at the location of anchor 232. For example, clamping features 254a, b may be positioned such that anchor 232 can press the natural valve against clamping features 254a, b. Anchor 232 can press the natural valve against clamping features 254a, b to reduce the likelihood of movement of the natural valve relative to outer frame 260. For example, anchor 232 can press the leaflet against the sealing body and against clamping features 254a, b to clamp the leaflet onto clamping features 254a, b. In this example, clamping features 254a, b may extend axially or may flare radially outward. Other configurations may be used in this example.

[0152] Figure 37 An exemplary schematic cross-sectional view illustrating a leaflet 236 positioned against a clamping feature 254b is shown. An anchor 232 presses the leaflet 236 against the clamping feature 254b to engage the clamping feature 254b with the leaflet 236. The leaflet 236 may be radially inwardly deflected or bent at the point of contact between the clamping feature 254b and the anchor 232. Inward deflection enhances the engagement between the clamping feature 254b and the leaflet 236 and further secures the leaflet 236 to the clamping feature 254b.

[0153] In this example, one or more clamping features 254 can be utilized. (See reference) Figure 34 In this example, the clamping features 254 may be circumferentially spaced to be positioned at the location of the anchor 232. Other locations of the clamping features 254 may also be utilized in this example.

[0154] Clamping feature 254 can reduce movement of leaflet 236 relative to sealing body 211. Clamping feature 254 can enhance fixation of the prosthetic valve to the implantation site. For example, clamping feature 254 can engage one or more leaflets of leaflet 236 to reduce the likelihood of proximal or distal movement of outer frame 260 relative to leaflet 236 and fix the orientation of outer frame 260 to the implantation site. Clamping feature 254 can reduce movement of leaflet 236 relative to sealing body 211. Clamping feature 254 can resist distal movement of the prosthetic heart valve.

[0155] In this example, the clamping feature 254 can be engageable due to the deployment procedure of the anchor 232. For example, the anchor 232 can extend linearly distally during the deployment procedure and can be flipped in place to extend proximally in the deployment configuration (e.g., as shown in the image). Figure 29 and Figure 41 (As shown in the diagram). Anchor 232 can be flipped into place to press against clamping feature 254 and secure leaflet 236 to clamping feature 254. Anchor 232 can be linearly extended and leaflet 236 released from clamping feature 254 by means of a recapture or repositioning procedure. Therefore, clamping feature 254 can be selectively engaged or disengaged by controlling the positioning of anchor 232.

[0156] Other forms of clamping features can be utilized in the examples.

[0157] For example, clamping feature 256 may be configured to engage a portion of a natural valve located more proximally than clamping feature 254. In an example, clamping feature 256 may be located proximal to clamping feature 254 on outer frame 260. Clamping feature 256 may be located on one or more struts of struts 262 and may extend in a direction toward one or more openings of openings 264. Clamping feature 256 may be located on a closed strut unit or may be located at other locations as needed.

[0158] The clamping feature 256 may be configured to engage the proximal portion of the leaflet 236, or it may be configured to engage the valve annulus of the natural valve. For example, Figure 38 An example is illustrated of a clamping feature 256 for a portion of the engaging leaflet 236. Other engagement locations may be utilized in the example (e.g., a portion of the annulus of a natural valve, or another portion as needed). In the example, the clamping feature 256 may extend axially or may flare radially outward.

[0159] Other forms of clamping features can be utilized in the examples.

[0160] For example, the clamping feature 258 may be configured to engage a portion of the natural valve in response to one or more anchors in the anchor 232 failing to capture the leaflet 236. For example, the clamping feature 258 may be configured to open radially outward such that contact between the clamping feature 258 and the leaflet 236 can result in engagement of the clamping feature 258 with the leaflet 236. Figure 39 This configuration is illustrated. Anchor 232 fails to capture leaflet 236. Therefore, anchor 232 is positioned radially inward of the miscaptured leaflet 236. When anchor 232 fails to capture leaflet 236, clamping feature 258 can engage the surface of the natural valve leaflet. Clamping feature 258 can project radially outward from anchor 232 and can engage with the inner surface of leaflet 236. Clamping feature 258 can thus secure outer frame 260 in place relative to leaflet 236 and prevent movement of outer frame 260 proximally or distally relative to leaflet 236. Outer frame 260 can form a seal with leaflet 236 to reduce the possibility of fluid flowing radially outward from outer frame 260 and from the prosthetic valve (e.g., perivalvular leakage).

[0161] Clamping features 254, 256, and 258 can have various configurations. In an example, clamping features 254, 256, and 258 may include barbs that are configured to penetrate tissue of a natural heart valve (e.g., a natural heart valve leaflet) to engage with the tissue. In an example, the barbs may extend distally or may have other orientations. Other configurations of clamping features 254, 256, and 258 may be utilized in an example.

[0162] Figure 40 and Figure 41 An exemplary deployment sequence of the prosthetic valve 210 is illustrated. The prosthetic valve 210 may include, regarding Figures 29 to 39 Any features disclosed include the use of one or more clamping features. Delivery device 268 can be used to access the implantation site. Delivery device 268 can be inserted percutaneously into the patient in a minimally invasive manner. In other instances, more invasive methods may be used as needed.

[0163] Delivery device 268 can be used for transcatheter delivery of valves. Delivery device 268 can be passed through a vein 270 or another part of the patient's vascular system. For example, it can be accessed via the jugular vein or other access methods as needed. Delivery device 268 can be delivered to the patient's heart 272.

[0164] Delivery device 268 can be used to deliver a valve to the tricuspid valve and can therefore be positioned within the right atrium 274 of the patient's heart for delivery to the tricuspid valve. In an example of delivery to the mitral valve, delivery device 268 can pass through the septum to reach the left atrium 276 for delivery to the mitral valve. Delivery device 268 can be advanced toward the left ventricle 278 of the patient's heart for mitral valve delivery.

[0165] The prosthetic valve 210 can be held within the capsule 280 of the delivery device 268 in a compressible or non-deployable configuration. The prosthetic valve 210 can be released from the capsule 280 at the implantation site. Figure 41 An example deployment configuration of the prosthetic valve is illustrated. Anchor 232 can be released from sac 280 to be positioned radially lateral to the natural valve leaflet 236. Sealing body 211 can be released from sac 280 to expand radially outward and contact the natural valve (e.g., the inward-facing surface of the natural valve leaflet 236). In this example, one or more of clamping features 254, 256, 258 can be used to secure sealing body 211 relative to the natural valve (e.g., relative to the natural valve leaflet 236) in the desired position.

[0166] The inner frame 218 can be connected to the sealing body 211 via one or more flexible bodies 246. Therefore, the inner frame 218 can be axially tilted or moved relative to the sealing body 211 to conform to the desired shape of the implantation site. This can result in improved sealing and / or reshaping of the natural valve.

[0167] In this example, the outer frame 260 of the sealing body 211 may be conformal to allow it to conform to the shape of the natural valve. For example, a natural valve with an irregular or "D" shape may conform to the shape of the outer frame 260. In this example, the inner frame 218 may maintain a symmetrical or uniform shape with the irregularly shaped outer frame 260. The outer frame 260 can seal against the natural valve.

[0168] Figures 29 to 41 The features can be used alone or in combination with any other instance in this article.

[0169] Other configurations of the prosthetic valve 210 can be used in the examples.

[0170] For example, Figure 42 and Figure 43 An example is illustrated where one or more flexible bodies 282 extend from the proximal end 212 of the sealing body 211 to the proximal portion 222 of the inner frame 218. The flexible body 282 may have a configuration similar to that of one or more flexible bodies 246. For example, the flexible body 282 may be configured to seal fluid flowing through it, thereby sealing the proximal end of the notch 248 accordingly. The flexible body 282 may be flexible to allow movement of the sealing body 211 relative to the inner frame 218 (e.g., tilting or axial movement of the sealing body 211 relative to the inner frame 218). Figure 42 A perspective view of a prosthetic valve with the proximal end of notch 248 closed is shown, and Figure 43 A cross-sectional schematic diagram of a prosthetic valve is illustrated. One or more flexible bodies 282 may include fabric bridging members extending to close the proximal end portion of the notch 248.

[0171] Figure 42 and Figure 43 The features can be used alone or in combination with any other instance in this article.

[0172] Other configurations of prosthetic valves can be utilized in the examples.

[0173] For example, Figure 44 An example is illustrated where the outer frame 284 of the sealing body is radially curled inward or tapered at its proximal portion 286 along a direction from the distal portion of the outer frame 284 toward the proximal portion of the outer frame 284. The distal portion 288 of the outer frame 284 may be radially curled outward or tapered at its distal portion 288 along a direction from the proximal portion 286 toward the distal portion 288 of the outer frame 284. The inner frame 218 may have a shape similar to that described above. Figures 29 to 31 The configurations discussed may be similar, or alternative configurations may be available in the instances as needed.

[0174] Figure 44 The features can be used alone or in combination with any other instance in this article.

[0175] In this example, the configuration of the prosthetic valve leaflet can be utilized. This configuration of the prosthetic valve leaflet can be used to reduce stagnation of fluid (e.g., blood) flow in the neosinus space of the prosthetic valve. For example, Figure 45Including an example of new sinus space 292 (in) Figure 45 An exemplary diagram of the positioning of the prosthetic valve 290 (marked by dashed lines). A neosinus space 292 may be positioned between the outward-facing surface 294 of one of the prosthetic valve leaflets 296 and the inward-facing surface 298 of the valve body 300 supporting the prosthetic valve leaflet 296. For example, the valve body 300 may be configured to impede fluid flow through the wall 302 of the valve body 300 by using a sealing skirt or another configuration of the wall 302 that impedes fluid flow through it. Therefore, the neosinus space 292 may include a space or pocket in which fluid can be retained.

[0176] The new sinus space 292 may include a space or pocket in which fluid can stagnate when the prosthetic valve leaflet 296 is opened or closed. The prosthetic valve leaflet 296 may be positioned around a flow channel 304 through which fluid flows. The inward-facing surface 306 of the prosthetic valve leaflet 296 may be configured to face the flow channel 304, wherein the outward-facing surface 294 is opposite to the inward-facing surface 306 and therefore opposite to the flow channel 304. The new sinus space 292 may have reduced fluid flow therethrough because fluid flowing through the flow channel 304 along the direction from the inflow edge 308 of the prosthetic valve leaflet 296 toward the outflow edge 310 of the prosthetic valve leaflet 296 may be prevented from being transmitted to the new sinus space 292 by the prosthetic valve leaflet 296. Therefore, less fluid flowing into the new sinus space 292 can lead to stagnation of fluid (e.g., blood), which may result in adverse outcomes (e.g., thrombosis and other adverse outcomes).

[0177] Repositioning the prosthetic valve leaflet 296 can also create new sinus space 312. For example, Figure 46 Example of Xiaoye 296 relative to Figure 45 The positioning shown is a repositioning in the outflow direction. A new sinus space 312 can exist between the outward-facing surface 294 of one of the prosthetic valve leaflets 296 and the inward-facing surface 298 of the valve body 300 supporting the prosthetic valve leaflet 296. The new sinus space 312 compared to... Figure 45 The space 292 shown can be smaller in size, but can create stagnation of fluid (e.g., blood) within the space 312.

[0178] Figure 47 and Figure 48 An example of a prosthetic valve leaflet 320 that can be used in the examples in this paper is shown. Figure 47 The diagram shows a planar pattern of the prosthetic valve leaflet 320. (Reference) Figure 47The prosthetic valve leaflet 320 may include an outflow edge 322, a first lateral commissure 324, and a second lateral commissure 326 positioned opposite the first lateral commissure 324. In an example, both the first lateral commissure 324 and the second lateral commissure 326 may extend axially. The prosthetic valve leaflet 320 may include a central portion 328 positioned between the first lateral commissure 324 and the second lateral commissure 326.

[0179] The prosthetic valve leaflet 320 may include an inflow edge 330 positioned opposite the outflow edge 322. In an example, the inflow edge 330 may include at least one notch 332 toward the central portion 328. The notch 332 may include a concave curvature in the inflow edge 330, or may have other configurations as needed. Figure 47 As shown, notch 332 can be positioned on the inflow edge 330 between the centerline 334 of leaflet 320 and the first side connection end 324 of leaflet 320, and notch 332 can also be positioned on the inflow edge 330 between the centerline 334 of leaflet 320 and the second side connection end 326 of leaflet 320. Notch 332 can be positioned symmetrically around the centerline 334, or it can have other positions as needed. In this example, a single notch or more than two notches can be used.

[0180] refer to Figure 47 One or more notches in notches 332 may be positioned along the prosthetic valve leaflet 320 from the outflow edge 322 toward the inflow edge 330 at a distance 336. In an example, one or more notches in notches 332 may have other locations (e.g., at least 30%, at least 50%, at least 60%, at least 70%, etc., along the prosthetic valve leaflet 320 from edge 322 toward edge 330 at a distance 336). In an example, at least two notches may be positioned symmetrically about an axially extending midline 334, or may have asymmetrical positioning.

[0181] One or more notches in notches 332 may be positioned along the prosthetic valve leaflet 320 from the midline 334 toward the first syndesmotic end 324 at a distance of at least 60% from 338. Another notch in notches 332 may similarly be positioned along the prosthetic valve leaflet 320 at a distance of at least 60% from the midline 334 toward the second syndesmotic end 326. Other percentages (e.g., at least 40%, at least 50%, at least 70%, at least 80%, etc.) from the midline 334 toward either the first syndesmotic end 324 or the second syndesmotic end 326 may be used.

[0182] The inflow edge 330 may include an outer portion 340, an inner portion 342, and an intermediate portion 344 between the outer portion 340 and the inner portion 342. In one example, the outer portion 340 may be convex relative to the central portion 328. In one example, the inner portion 342 may be convex relative to the central portion 328. In one example, the intermediate portion 344 may include a portion of the inflow edge 330 that includes one or more notches 332. The inner portion 342 and the outer portion 340 may have a parabolic shape or other curvature that curves in the inflow direction, and in one example, the one or more notches may have a parabolic shape or other curvature that curves toward the central portion 328.

[0183] In an example, the inflow edge 330 may include a connecting line 339, which can be used to connect the leaflet 320 to other parts of the leaflet support structure, such as the skirt 341 (in Figure 48 (marked in the middle) or other support material. In an example, the connecting line 339 may include a suture thread that can be used to sew the leaflet 320 to the skirt 341 or other support material. In an example, the suture thread may follow the contour of the inflow edge 330 and may have the shape of the inflow edge 330.

[0184] In an example, the corresponding side connection ends 324, 326 may include for connecting leaflet 320 to a support material (such as a skirt) or directly to adjacent leaflets 320a, b (such as...). Figure 48 The connecting lines (marked in the diagram). The corresponding side connecting ends 324, 326 may include the connecting portions of adjacent leaflets 320, 320a, 320b (as shown in the diagram). Figure 48 (As shown).

[0185] In this example, the corresponding side-jointing ends 324, 326 may include tabs for connecting adjacent leaflets 320, 320a, 320b to each other. In this example, the tabs may also be configured for attachment to a frame or insertion into a hole in the frame.

[0186] In this example, one or more notches 332 can reduce the size of the new sinus space. (See reference) Figure 47 One or more notches 332 can reduce the size of the area located between the outward-facing surface 346 of the leaflet 320 and the inward-facing surface 348 of the valve body 350 (in Figure 49 (Marked in the middle). The size of the decrease in the new sinus space 352 (in Figure 49 (The marked area) can reduce the likelihood of fluid stagnation in the closed region including the new sinus space 352, and reduce the likelihood of adverse outcomes (e.g., thrombosis or other adverse outcomes) due to stagnation in the new sinus space 352. Furthermore, as... Figure 47As indicated by flow arrow 351, one or more notches 332 can guide fluid flow toward the inner portion 342 of the leaflet 320. Fluid flow toward the inner portion 342 can clear fluid from the inner portion 342 during the contraction and relaxation movements of the leaflet 320. Figure 47 As indicated by the flow arrow 353, the fluid can be guided toward the outflow edge 322. This reduces fluid stagnation at the interior portion 342 and otherwise in the new sinus space 352.

[0187] Figure 48 An arrangement of three prosthetic valve leaflets 320, 320a, and 320b connected together is illustrated. Leaflets 320a and 320b may each be constructed similarly to leaflet 320. The respective lateral commissure ends of the prosthetic valve leaflets 320, 320a, and 320b may be joined together. Each of the prosthetic valve leaflets 320, 320a, and 320b may be connected to a corresponding skirt 341, which may be used to seal the flow or to connect the leaflet 320, 320a, and 320b to the frame or other part of the valve body. In this example, three prosthetic valve leaflets 320, 320a, and 320b or fewer (e.g., two) or more prosthetic valve leaflets may be used as needed. In this example, the outflow edge 322 of the leaflets 320, 320a, and 320b may include a mating surface.

[0188] Figure 49 A schematic diagram illustrating leaflets 320, 320a positioned within the valve body 360 is shown. Corresponding inflow edges 330a may be attached to the valve body 360, wherein corresponding outflow edges 322, 322a extend in the outflow direction. The valve body 360 may, in this example, have a cylindrical shape, or may have other shapes as needed.

[0189] In this example, the valve body 360° can be rolled radially inward. For example, Figure 50 A cross-sectional view of a portion of a valve body 362 with radially inward curvature is illustrated. The leaflet 320 is shown in the cross-sectional view as being in an open configuration (i.e., the valve leaflet is open to allow fluid to flow through the flow channel). The outward-facing surface 346 of the leaflet 320 can conform to the shape of the valve body 360 in the open configuration to close a portion of the neosinus space at the inner portion 342 of the prosthetic leaflet 320, and thus eject fluid from this portion of the neosinus space during leaflet opening. Therefore, the possibility of stagnation due to the neosinus space can be reduced.

[0190] In the example, different stitches or suture patterns can be used to produce the reduced size of the new sinus space in the example.

[0191] Figures 47 to 50The features can be used alone or in combination with any other instance in this article.

[0192] Various modifications to the instances disclosed herein can be provided. Instance features can be modified, replaced, excluded, or combined across instances as needed. Combinations of features across instances can be provided as needed. Combinations of features across instances can be provided, and other features of such instances can be excluded if necessary.

[0193] The various examples of sealing skirts disclosed herein can take many forms, including fabric skirts, foam skirts, or woven skirts as needed. Various materials can be used as required.

[0194] Various examples of prosthetic valve leaflets can be made from a variety of materials as needed. Prosthetic valve leaflets can be made from pericardium, preferably from bovine or equine pericardium. Other materials, such as polymers, can also be used.

[0195] The implants disclosed herein may include prosthetic heart valves or other forms of implants, such as stents or filters, or diagnostic devices. Implants may be expandable implants configured to move from a compressed or undeployed state to an expanded or deployed state. Implants may be compressible implants configured to compress inward to have a reduced external profile and to move the implant to a compressed or undeployed state.

[0196] Various forms of delivery devices can be used in conjunction with the examples disclosed herein. The delivery devices disclosed herein can also be used for replacement and repair of the aorta, mitral valve, tricuspid valve, and lung. Delivery devices may include delivery devices for delivering other forms of implants, such as stents or filters, or diagnostic devices.

[0197] The implants and systems disclosed herein can be used for transcatheter mitral or tricuspid valve implantation, as well as aortic valve implantation (TAVI) or replacement of other natural heart valves (e.g., pulmonary valves). The delivery devices and systems disclosed herein can be used for transarterial access (including via the femoral artery) to a patient's heart. The delivery devices and systems can be used for percutaneous transcatheter procedures, including transarterial procedures. Access can be via the femoral artery or the jugular vein. Transapical procedures, etc., can also be used. Other procedures can be utilized as needed.

[0198] Furthermore, the methods described herein are not limited to those specifically described, and may include methods utilizing the systems and apparatus disclosed herein. Steps of the methods may be modified, excluded, or added using the systems, apparatus, and methods disclosed herein. In some instances, the examples disclosed herein may include systems for implantation in the human body.

[0199] For the purposes of this description, certain aspects, advantages, and novel features of embodiments of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Rather, this disclosure relates to all novel and non-obvious features and aspects of the various disclosed embodiments, individually and in various combinations and sub-combinations with each other. These methods, apparatuses, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments do not require the presence of any one or more particular advantages or problems solved. Features, elements, or components of one embodiment may be combined into other embodiments herein.

[0200] Example 1: A prosthetic valve for deployment onto a natural valve, the prosthetic valve comprising: a plurality of prosthetic valve leaflets positioned around a flow channel of the prosthetic valve and having a plurality of junctions; a valve frame for supporting the plurality of prosthetic valve leaflets and capable of radially expanding outward from a compression configuration to an expansion configuration, the valve frame comprising: a first support arm extending axially and supporting at least two of the plurality of prosthetic valve leaflets at a first junction of the plurality of junctions; a second support arm extending axially and supporting at least two of the plurality of prosthetic valve leaflets at a second junction of the plurality of junctions; an opening circumferentially positioned between the first support arm and the second support arm and for allowing blood flow therethrough; and a sealing frame for sealing with the natural valve.

[0201] Example 2: A prosthetic valve as described in any of the examples herein, particularly Example 1, wherein the first prosthetic valve leaflet of the plurality of prosthetic valve leaflets includes a first suture end portion located at the first suture portion and a second suture end portion located at the second suture portion, and a central portion located between the first suture end portion and the second suture end portion, and the opening is circumferentially aligned with the central portion of the first prosthetic valve leaflet.

[0202] Example 3: A prosthetic valve as described in any of the examples herein, particularly Example 1 or Example 2, wherein the opening extends from the first support arm to the second support arm.

[0203] Example 4: A prosthetic valve as described in any of the examples herein, particularly Examples 1 to 3, wherein the opening is U-shaped.

[0204] Example 5: A prosthetic valve as described in any of the examples herein, particularly Examples 1 to 4, wherein the first support arm extends axially in the outflow direction to the free end of the first support arm.

[0205] Example 6: A prosthetic valve as described in any of the examples herein, particularly Examples 1 to 5, wherein the valve frame includes a third support arm that extends axially and supports at least two of the plurality of prosthetic valve leaflets at a third joint of the plurality of joints.

[0206] Example 7: A prosthetic valve as described in any of the examples herein, particularly Example 6, wherein the first support arm, the second support arm, and the third support arm are circumferentially spaced apart from each other.

[0207] Example 8: As described in any of the examples herein, particularly Examples 1 to 7, the prosthetic valve further includes a sealing skirt positioned on the sealing frame.

[0208] Example 9: A prosthetic valve as described in any of the examples herein, particularly Example 8, wherein the sealing frame protrudes radially outward from the valve frame.

[0209] Example 10: A prosthetic valve as described in any of the examples herein, particularly Examples 1 to 9, wherein the proximal portion of the prosthetic valve includes an inflow portion and the distal portion of the prosthetic valve includes an outflow portion, and the sealing frame includes a proximal portion that projects radially outward from the proximal end of the sealing frame.

[0210] Example 11: A prosthetic valve as described in any of the examples herein, particularly Example 10, wherein the sealing frame includes a distal portion extending in the distal direction.

[0211] Example 12: A prosthetic valve as described in any of the examples herein, particularly Example 11, wherein the sealing frame includes a curled portion positioned between the proximal portion and the distal portion.

[0212] Example 13: A prosthetic valve as described in any of the examples herein, particularly Examples 1 to 12, wherein the sealing frame surrounds the first support arm and the second support arm.

[0213] Example 14: A prosthetic valve as described in any of the examples herein, particularly Examples 1 to 13, wherein the sealing frame is spaced apart from the valve frame by a notch.

[0214] Example 15: A prosthetic valve as described in any of the examples herein, particularly Example 14, wherein the notch forms at least a portion of a ring extending around the valve frame.

[0215] Example 16: The prosthetic valve as described in any of the examples herein, particularly Example 14 or Example 15, further includes one or more flow barriers positioned within the notch.

[0216] Example 17: A prosthetic valve as described in any of the examples herein, particularly Examples 1 to 16, wherein the proximal portion of the prosthetic valve includes an inflow portion and the distal portion of the prosthetic valve includes an outflow portion, and the proximal portion of the valve frame is coupled to the proximal portion of the sealing frame.

[0217] Example 18: A prosthetic valve as described in any of the examples herein, particularly Example 17, wherein the distal portion of the sealing frame is spaced apart from the valve frame to form an opening for the interior of the sealing frame.

[0218] Example 19: A prosthetic valve as described in any of the examples herein, particularly Examples 1 to 18, wherein the proximal portion of the prosthetic valve includes an inflow portion and the distal portion of the prosthetic valve includes an outflow portion, and the distal end of the valve frame is positioned distal to the distal end of the sealing frame.

[0219] Example 20: A prosthetic valve as described in any of the examples herein, particularly Examples 1 to 19, wherein the opening forms a blood flow path not covered by the sealing frame.

[0220] Example 21: Prosthetic valves as described in any of the examples herein, particularly Examples 1 to 20, wherein the plurality of prosthetic valve leaflets are positioned to remain under or above the annulus relative to the natural valve.

[0221] Example 22: As described in any of the examples herein, particularly Examples 1 to 21, the prosthetic valve further includes an anchoring frame modularly connected to the valve frame.

[0222] Example 23: A prosthetic valve as described in any of the examples herein, particularly Example 22, wherein the anchoring frame comprises a grid structure of struts and openings.

[0223] Example 24: A prosthetic valve as described in any of the examples herein, particularly Example 22 or Example 23, wherein the anchoring frame has a cylindrical shape.

[0224] Example 25: The prosthetic valve as described in any of the examples herein, particularly Examples 1 to 24, further includes one or more anchors for anchoring the prosthetic valve to the natural valve.

[0225] Example 26: A prosthetic valve as described in any of the examples herein, particularly Example 25, wherein one or more anchors include hooks.

[0226] Example 27: A prosthetic valve as described in any of the examples herein, particularly Example 25 or Example 26, wherein one or more anchors are shaped to extend above the distal tip of the natural leaflet of the natural valve.

[0227] Example 28: A prosthetic valve as described in any of the examples herein, particularly Examples 25 to 27, wherein one or more anchors extend from one or more of the first support arm or the second support arm.

[0228] Example 29: A prosthetic valve as described in any of the examples herein, particularly Examples 25 to 28, wherein one or more anchors extend from the sealing frame.

[0229] Example 30: A prosthetic valve as described in any of the examples herein, particularly Examples 25 to 29, further comprising an anchoring frame modularly coupled to the valve frame, wherein one or more anchors extend from the anchoring frame.

[0230] Example 31: A prosthetic valve as described in any of the examples herein, particularly Example 30, wherein the proximal portion of the prosthetic valve includes an inflow portion and the distal portion of the prosthetic valve includes an outflow portion, and wherein one or more anchors are positioned proximal to the blood flow path formed by the opening.

[0231] Example 32: A prosthetic valve as described in any of the examples herein, particularly Examples 1 to 31, wherein the sealing frame comprises a mesh structure of struts and openings.

[0232] Example 33: A prosthetic valve as described in any of the examples herein, particularly Examples 1 to 32, wherein the sealing frame is capable of radially expanding outward from a compression configuration to an expansion configuration.

[0233] Example 34: A prosthetic valve as described in any of the examples herein, particularly Examples 1 to 33, wherein the prosthetic valve is adapted to be delivered to the natural valve via a catheter.

[0234] Example 35: Prosthetic valves as described in any of the examples herein, particularly Examples 1 to 34, wherein the prosthetic valves include prosthetic mitral valves or prosthetic tricuspid valves.

[0235] Example 36: A method comprising: deploying a prosthetic valve onto a natural valve, the prosthetic valve including: a plurality of prosthetic valve leaflets positioned around a flow channel of the prosthetic valve and having a plurality of junctions; a valve frame for supporting the plurality of prosthetic valve leaflets and capable of radially expanding outward from a compression configuration to an expansion configuration, the valve frame including: a first support arm extending axially and supporting at least two of the plurality of prosthetic valve leaflets at a first junction of the plurality of junctions; a second support arm extending axially and supporting at least two of the plurality of prosthetic valve leaflets at a second junction of the plurality of junctions; an opening circumferentially positioned between the first support arm and the second support arm and for allowing blood flow therethrough; and a sealing frame for sealing with the natural valve.

[0236] Example 37: The method described in any of the examples herein, particularly Example 36, wherein the first prosthetic leaflet of the plurality of prosthetic leaflets includes a first suture end portion located at the first suture portion and a second suture end portion located at the second suture portion, and a central portion located between the first suture end portion and the second suture end portion, and the opening is circumferentially aligned with the central portion of the first prosthetic leaflet.

[0237] Example 38: The method described in any of the examples in this document, particularly Example 36 or Example 37, wherein the opening is U-shaped.

[0238] Example 39: The method as described in any of the examples herein, particularly Examples 36 to 38, wherein the valve frame includes a third support arm that extends axially and supports at least two of the plurality of prosthetic valve leaflets at a third joint of the plurality of joints.

[0239] Example 40: The method as described in any of the examples herein, particularly Examples 36 to 39, wherein the proximal portion of the prosthetic valve includes an inflow portion and the distal portion of the prosthetic valve includes an outflow portion, and the sealing frame includes a proximal portion that projects radially outward from the proximal end of the sealing frame.

[0240] Example 41: The method described in any of the examples herein, particularly Examples 36 to 40, wherein the sealing frame surrounds the first support arm and the second support arm.

[0241] Example 42: The method as described in any of the examples herein, particularly Examples 36 to 41, wherein the proximal portion of the prosthetic valve includes an inflow portion and the distal portion of the prosthetic valve includes an outflow portion, and the proximal portion of the valve frame is coupled to the proximal portion of the sealing frame.

[0242] Example 43: The method as described in any of the examples herein, particularly Examples 36 to 42, wherein the proximal portion of the prosthetic valve includes an inflow portion and the distal portion of the prosthetic valve includes an outflow portion, and the distal end of the valve frame is positioned distal to the distal end of the sealing frame.

[0243] Example 44: The method described in any of the examples in this document, particularly Examples 36 to 43, wherein the anchoring frame is modularly connected to the valve frame.

[0244] Example 45: The method described in any of the examples herein, particularly Examples 36 to 44, wherein the natural valve is a mitral or tricuspid heart valve.

[0245] Example 46: A prosthetic valve for deployment onto a natural valve, the prosthetic valve comprising: a plurality of prosthetic valve leaflets; an inner frame supporting the plurality of prosthetic valve leaflets and having a proximal portion and a distal portion; a plurality of anchors positioned at the distal portion of the inner frame and adapted to engage with the natural valve; a sealing body positioned radially outward from the inner frame and having a proximal end and a distal end engaged with the distal portion of the inner frame such that the sealing body is adapted to move relative to the inner frame; and one or more clamping features positioned on the sealing body and adapted to engage a portion of the natural valve.

[0246] Example 47: A prosthetic valve as described in any of the examples herein, particularly Example 46, wherein one or more flexible bodies connect the distal end of the sealing body to the distal portion of the inner frame and allow the sealing body to move relative to the inner frame.

[0247] Example 48: A prosthetic valve as described in any of the examples herein, particularly Example 47, wherein one or more flexible bodies comprise fabric or shape memory material.

[0248] Example 49: A prosthetic valve as described in any of the examples herein, particularly Example 47 or Example 48, wherein one or more flexible bodies form a ring positioned at the distal end of the sealing body.

[0249] Example 50: A prosthetic valve as described in any of the examples herein, particularly Examples 47 to 49, wherein one or more flexible bodies are closedly positioned at the distal end portion of an annular notch between the sealing body and the inner frame.

[0250] Example 51: A prosthetic valve as described in any of the examples herein, particularly Examples 46 to 50, wherein the inner frame extends about a first axis and the sealing body extends about a second axis, and the distal end is coupled to the distal portion of the inner frame such that the sealing body is adapted to tilt relative to the inner frame to deviate the first axis from the second axis.

[0251] Example 52: A prosthetic valve as described in any of the examples herein, particularly Examples 46 to 51, wherein the distal end is coupled to the distal portion of the inner frame such that the sealing body is adapted to move axially relative to the inner frame.

[0252] Example 53: A prosthetic valve as described in any of the examples herein, particularly Examples 46 to 52, wherein the sealing body is spaced apart from the inner frame by an annular notch, and the proximal end of the sealing body forms an opening for the annular notch.

[0253] Example 54: A prosthetic valve as described in any of the examples herein, particularly Examples 46 to 53, wherein the sealing body is spaced apart from the inner frame by an annular notch, and a fabric bridging member extends from the proximal end of the sealing body to the proximal portion of the inner frame to close the proximal end portion of the annular notch.

[0254] Example 55: A prosthetic valve as described in any of the examples herein, particularly Examples 46 to 54, wherein the inner frame comprises a first frame and the sealing body comprises a second frame and a sealing skirt.

[0255] Example 56: A prosthetic valve as described in any of the examples herein, particularly Examples 46 to 55, wherein the sealing body tapers radially inward along a direction from the proximal end toward the distal end.

[0256] Example 57: A prosthetic valve as described in any of the examples herein, particularly Examples 46 to 56, wherein the proximal end portion of the sealing body is radially outwardly flared in a direction from the distal end of the sealing body toward the proximal end of the sealing body.

[0257] Example 58: A prosthetic valve as described in any of the examples herein, particularly Examples 46 to 57, wherein the proximal portion of the inner frame is radially outwardly flared in a direction from the distal portion of the inner frame toward the proximal portion of the inner frame.

[0258] Example 59: A prosthetic valve as described in any of the examples herein, particularly Examples 46 to 58, wherein the sealing body comprises a frame having a plurality of struts, wherein the distal tips of the plurality of struts are radially outwardly flared.

[0259] Example 60: A prosthetic valve as described in any of the examples herein, particularly Examples 46 to 59, wherein the plurality of anchors are adapted to press one or more natural valve leaflets against the sealing body.

[0260] Example 61: A prosthetic valve as described in any of the examples herein, particularly Examples 46 to 60, wherein the plurality of anchors are adapted to hook around and retain the natural leaflet of the natural valve at its distal end between the plurality of anchors and the sealing body.

[0261] Example 62: A prosthetic valve as described in any of the examples herein, particularly Examples 46 to 51, wherein one or more clamping features are adapted to reduce movement of one or more natural valve leaflets relative to the sealing body.

[0262] Example 63: A prosthetic valve as described in any of the examples herein, particularly Examples 46 to 62, wherein the plurality of anchors are adapted to press one or more natural valve leaflets toward the one or more clamping features to resist distal movement of the prosthetic valve.

[0263] Example 64: A prosthetic valve as described in any of the examples herein, particularly Examples 46 to 63, wherein one or more clamping features are adapted to engage the surface of the natural valve when one of the anchors fails to capture one or more natural valve leaflets.

[0264] Example 65: A prosthetic valve as described in any of the examples herein, particularly Examples 46 to 64, wherein one or more clamping features include one or more barbs.

[0265] Example 66: A prosthetic valve as described in any of the examples herein, particularly Example 65, wherein one or more barbs extend distally.

[0266] Example 67: A prosthetic valve as described in any of the examples herein, particularly Example 65 or Example 66, wherein the sealing body comprises a frame having a plurality of struts, and the one or more barbs are positioned on at least one of the plurality of struts.

[0267] Example 68: A prosthetic valve as described in any of the examples herein, particularly Example 67, wherein the plurality of struts define a plurality of openings in the frame of the sealing body, and the one or more barbs extend toward at least one of the plurality of openings.

[0268] Example 69: A prosthetic valve as described in any of the examples herein, particularly Examples 65 to 68, wherein one or more barbs are positioned for the plurality of anchors to press the natural valve leaflet against the one or more barbs.

[0269] Example 70: A prosthetic valve as described in any of the examples herein, particularly Examples 46 to 69, wherein the prosthetic valve is intended for deployment to the mitral or tricuspid valve.

[0270] Example 71: A method comprising: deploying a prosthetic valve onto a natural valve, the prosthetic valve including: a plurality of prosthetic valve leaflets; an inner frame supporting the plurality of prosthetic valve leaflets and having a proximal portion and a distal portion; a plurality of anchors positioned at the distal portion of the inner frame and adapted to engage with the natural valve; a sealing body positioned radially outward from the inner frame and having a proximal end and a distal end engaged with the distal portion of the inner frame such that the sealing body is adapted to move relative to the inner frame; and one or more clamping features positioned on the sealing body and adapted to engage a portion of the natural valve.

[0271] Example 72: The method as described in any of the examples herein, particularly Example 71, wherein one or more flexible bodies connect the distal end of the sealing body to the distal portion of the inner frame and allow the sealing body to move relative to the inner frame.

[0272] Example 73: The method as described in any of the examples herein, particularly Example 71 or Example 72, wherein the inner frame extends about a first axis and the sealing body extends about a second axis, and the distal end is coupled to the distal portion of the inner frame such that the sealing body is adapted to tilt relative to the inner frame to deviate the first axis from the second axis.

[0273] Example 74: The method as described in any of the examples herein, particularly Examples 71 to 73, wherein the distal end is coupled to the distal portion of the inner frame such that the sealing body is adapted to move axially relative to the inner frame.

[0274] Example 75: The method as described in any of the examples herein, particularly Examples 71 to 74, wherein the sealing body is spaced apart from the inner frame by an annular notch, and the proximal end of the sealing body forms an opening for the annular notch.

[0275] Example 76: The method as described in any of the examples herein, particularly Examples 71 to 75, wherein the sealing body is spaced apart from the inner frame by an annular notch, and the proximal end of the sealing body forms an opening for the annular notch.

[0276] Example 77: The method as described in any of the examples herein, particularly Examples 71 to 76, wherein the sealing body is spaced apart from the inner frame by an annular notch, and a fabric bridging member extends from the proximal end of the sealing body to the proximal portion of the inner frame to close the proximal end portion of the annular notch.

[0277] Example 78: The method described in any of the examples herein, particularly Examples 71 to 77, wherein the inner frame comprises a first frame and the sealing body comprises a second frame and a sealing skirt.

[0278] Example 79: The method as described in any of the examples herein, particularly Examples 71 to 78, wherein the sealing body tapers radially inward along a direction from the proximal end toward the distal end.

[0279] Example 80: The method described in any of the examples herein, particularly Examples 71 to 79, wherein the natural valve is a mitral or tricuspid heart valve.

[0280] Example 81: A prosthetic valve for deployment to a natural valve, the prosthetic valve comprising: a valve body; and a plurality of prosthetic valve leaflets connected to the valve body, each of the plurality of prosthetic valve leaflets comprising: an outflow edge, a first lateral commissure end, a second lateral commissure end positioned opposite to the first lateral commissure end, a central portion positioned between the first lateral commissure end and the second lateral commissure end, and an inflow edge positioned opposite to the outflow edge, the inflow edge including at least one notch toward the central portion.

[0281] Example 82: A prosthetic valve as described in any of the examples herein, particularly Example 81, wherein both the first lateral suture and the second lateral suture extend axially.

[0282] Example 83: A prosthetic valve as described in any of the examples herein, particularly Example 81 or Example 82, wherein at least one notch is concave relative to the central portion.

[0283] Example 84: A prosthetic valve as described in any of the examples herein, particularly Examples 81 to 83, wherein the inflow edge includes an outer portion, an inner portion, and an intermediate portion between the outer portion and the inner portion, and the outer portion is convex relative to the central portion, the intermediate portion includes at least one notch, and the inner portion is convex relative to the central portion.

[0284] Example 85: A prosthetic valve as described in any of the examples herein, particularly Examples 81 to 84, wherein each of the plurality of prosthetic valve leaflets includes at least two notches.

[0285] Example 86: A prosthetic valve as described in any of the examples herein, particularly Examples 81 to 85, wherein each of the plurality of prosthetic valve leaflets is symmetrical about the midline of the axial extension of the respective prosthetic valve leaflet.

[0286] Example 87: A prosthetic valve as described in any of the examples herein, particularly Examples 81 to 86, wherein the at least one notch is positioned along the respective prosthetic valve leaflet at a distance of at least 40% from the outflow edge toward the inflow edge.

[0287] Example 88: A prosthetic valve as described in any of the examples herein, particularly Examples 81 to 87, wherein the inflow edge includes a connecting line.

[0288] Example 89: A prosthetic valve as described in any of the examples herein, particularly Examples 81 to 88, wherein the inflow edge includes a suture.

[0289] Example 90: A prosthetic valve as described in any of the examples herein, particularly Examples 81 to 89, wherein the plurality of prosthetic valve leaflets comprises at least three prosthetic valve leaflets.

[0290] Example 91: A prosthetic valve as described in any of the examples herein, particularly Examples 81 to 90, wherein the plurality of prosthetic valve leaflets reduce the size of the new sinus space.

[0291] Example 92: A prosthetic valve as described in any of the examples herein, particularly Examples 81 to 91, wherein the outflow edges of the plurality of prosthetic valve leaflets include an engagement surface.

[0292] Example 93: A prosthetic valve as described in any of the examples herein, particularly Examples 81 to 92, wherein the first lateral suture and the second lateral suture each include a flap.

[0293] Example 94: A prosthetic valve as described in any of the examples herein, particularly Examples 81 to 93, wherein the valve body includes a frame supporting the plurality of prosthetic valve leaflets.

[0294] Example 95: A prosthetic valve as described in any of the examples herein, particularly Examples 81 to 94, wherein the prosthetic valve is intended for deployment to the mitral or tricuspid valve.

[0295] Example 96: A method comprising: deploying a prosthetic valve onto a natural valve, the prosthetic valve comprising: a valve body and a plurality of prosthetic valve leaflets conjoined to the valve body, each of the plurality of prosthetic valve leaflets comprising: an outflow edge, a first lateral commissure end, a second lateral commissure end positioned opposite to the first lateral commissure end, a central portion positioned between the first lateral commissure end and the second lateral commissure end, and an inflow edge positioned opposite to the outflow edge, the inflow edge comprising at least one notch toward the central portion.

[0296] Example 97: The method as described in any of the examples herein, particularly Example 96, wherein both the first side joint and the second side joint extend axially.

[0297] Example 98: The method as described in any of the examples herein, particularly Example 96 or Example 97, wherein the at least one notch is concave relative to the central portion.

[0298] Example 99: The method as described in any of the examples herein, particularly Examples 96 to 98, wherein the inflow edge includes an outer portion, an inner portion, and an intermediate portion between the outer portion and the inner portion, and the outer portion is convex relative to the central portion, the intermediate portion includes at least one notch, and the inner portion is convex relative to the central portion.

[0299] Example 100: The method as described in any of the examples herein, particularly Examples 96 to 99, wherein each of the plurality of prosthetic valve leaflets includes at least two notches.

[0300] Example 101: The method as described in any of the examples herein, particularly Examples 96 to 100, wherein each of the plurality of prosthetic valve leaflets is symmetrical about the midline of the axial extension of the respective prosthetic valve leaflet.

[0301] Example 102: The method as described in any of the examples herein, particularly Examples 96 to 101, wherein the at least one notch is positioned along the corresponding prosthetic valve leaflet at a distance of at least 40% from the outflow edge toward the inflow edge.

[0302] Example 103: The method described in any of the examples herein, particularly Examples 96 to 102, wherein the inflow edge includes a connecting line.

[0303] Example 104: The method described in any of the examples in this document, particularly Examples 96 to 103, wherein the plurality of prosthetic valve leaflets reduce the size of the new sinus space.

[0304] Example 105: The method described in any of the examples herein, particularly Examples 96 to 104, wherein the natural valve is a mitral or tricuspid heart valve.

[0305] Finally, it should be understood that although various aspects of this specification have been highlighted with reference to specific examples, those skilled in the art will readily recognize that these disclosed examples are merely illustrative of the principles of the subject matter disclosed herein. Therefore, it should be understood that the disclosed subject matter is by no means limited to the specific methods, schemes, and / or reagents described herein. Consequently, various modifications, alterations, or alternative configurations can be made to the disclosed subject matter based on the teachings herein without departing from the spirit of this specification. Finally, the terminology used herein is for the purpose of describing particular examples only and is not intended to limit the scope of the systems, apparatus, and methods disclosed herein, which is defined only by the claims. Therefore, the systems, apparatus, and methods are not limited to the precise contents shown and described.

[0306] This document describes certain examples of systems, apparatuses, and methods, including the best modes known to the inventors for performing these examples. Of course, variations of these described examples will become apparent to those skilled in the art after reading the foregoing description. The inventors expect those skilled in the art to appropriately employ such variations, and the inventors intend to practice the systems, apparatuses, and methods differently from those specifically described herein. Therefore, the systems, apparatuses, and methods include all modifications and equivalents of the subject matter described in the appended claims as permitted by applicable law. Furthermore, unless otherwise stated herein or clearly contradicted by the context, the systems, apparatuses, and methods encompass any combination of the foregoing examples in all their possible variations.

[0307] Alternative instances, elements, or steps of the systems, devices, and methods described herein should not be construed as limiting. Each member of a group may be mentioned and claimed individually or in any combination with other members of the groups disclosed herein. One or more members of a group may be included in or removed from the group for convenience and / or patentability reasons. When any such inclusion or removal occurs, the specification is deemed to contain the modified group and thus satisfy the written description of all Markush groups used in the appended claims.

[0308] Unless otherwise stated, all figures used in this specification and claims to represent features, items, quantities, parameters, properties, terms, etc., shall be understood to be modified by the term "about" in all cases. As used herein, the term "about" means an approximate value that such a defined feature, item, quantity, parameter, property, or term covers, which may vary but is capable of performing the desired operation or process discussed herein.

[0309] Unless otherwise stated herein or clearly contradicted by the context, the terms “a,” “the,” and similar designations used in the context of describing systems, devices, and methods (particularly in the context of the appended claims) shall be construed as encompassing both the singular and plural. Unless otherwise stated herein or otherwise clearly contradicted by the context, all methods described herein may be performed in any suitable order. The use of any and all instances or exemplary language (e.g., “such as”) provided herein is intended only to better elucidate the systems, devices, and methods and does not constitute a limitation on the scope of the claimed systems, devices, and methods. No language in this specification should be construed as indicating any unclaimed element essential to the practice of the systems, devices, and methods.

[0310] All patents, patent publications, and other publications referenced and identified in this specification are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing, for example, compositions and methods that may be used in conjunction with systems, devices, and methods as described in such publications. These publications are provided solely for their disclosure prior to the filing date of this application. Nothing in this regard should be construed as an admission that the inventor has a right to use prior art or for any other reason prior to such disclosure. All statements regarding the dates or contents of these documents are based on information available to the applicant and do not constitute any admission of the accuracy of the dates or contents of these documents.

Claims

1. A prosthetic valve for deployment in a natural mitral or tricuspid valve, the prosthetic valve comprising: Three prosthetic valve leaflets are positioned around the flow channel of the prosthetic valve, and the three leaflets are attached to form three commissural regions; A valve frame for supporting the prosthetic valve leaflets, wherein the valve frame is capable of radially expanding from a compression configuration to an expansion configuration, the valve frame including three cantilevered support arms extending in the axial direction for supporting the three fusion regions, wherein three openings are provided between the three cantilevered support arms for reducing thrombosis and improving leaflet fusion. as well as An external sealing frame positioned radially outside the valve frame, wherein the sealing frame engages the natural mitral or tricuspid valve.

2. The prosthetic valve of claim 1, wherein each opening is circumferentially aligned with the central portion of a corresponding prosthetic valve leaflet in the prosthetic valve leaflet.

3. The prosthetic valve of claim 1 or claim 2, wherein the sealing frame has a concave shape facing the ventricle for directing blood to the valve frame and the prosthetic valve leaflet.

4. The prosthetic valve as claimed in any one of claims 1 to 3, wherein the opening between the cantilever support arms is substantially unobstructed.

5. The prosthetic valve as described in any one of claims 1 to 4, wherein the three cantilever support arms are flexible in the radial direction.

6. The prosthetic valve of any one of claims 1 to 5, wherein each cantilever support arm further includes a strut for resisting inward bending and outward curling of a corresponding cantilever support arm.

7. The prosthetic valve of claim 6, wherein each outwardly curled strut is circumferentially aligned with a corresponding commissural region in the commissural region.

8. The prosthetic valve as claimed in any one of claims 1 to 7, wherein the prosthetic valve further comprises a fabric sealing skirt positioned on a majority portion of the sealing frame.

9. The prosthetic valve as claimed in any one of claims 1 to 8, wherein the inflow portion of the valve frame is coupled to the inflow portion of the sealing frame.

10. The prosthetic valve of any one of claims 1 to 9, wherein the outlet end of the valve frame is positioned further downstream than the outlet end of the sealing frame.

11. The prosthetic valve of any one of claims 1 to 10, wherein the outlet end of the valve frame does not contact the outlet end of the sealing frame, and wherein a gap is provided between them.

12. The prosthetic valve of claim 11, wherein three flow barriers extend between the sealing frame and the three cantilever support arms, thereby providing three discrete regions within the sealing frame for improved flushing.

13. The prosthetic valve of any one of claims 1 to 12, wherein the sealing frame further comprises barbs along the outer surface.

14. The prosthetic valve of any one of claims 1 to 13, wherein the valve frame is positioned in the natural ventricle after deployment.

15. The prosthetic valve of any one of claims 1 to 14, wherein the prosthetic valve further comprises an anchoring frame positioned along the inlet end of the prosthetic valve.

16. The prosthetic valve of claim 15, wherein the anchoring frame has a cylindrical shape.

17. The prosthetic valve of any one of claims 1 to 16, wherein the prosthetic valve further comprises a plurality of coiled elongated anchors for capturing the natural leaflets of the natural mitral or tricuspid valve between the coiled elongated anchors and the sealing frame.

18. The prosthetic valve of claim 17, wherein the coiled elongated anchor is configured to bend during deployment.

19. The prosthetic valve of claim 17 or claim 18, wherein the coiled elongated anchor extends radially outward from the sealing frame.

20. The prosthetic valve of any one of claims 1 to 19, wherein the sealing frame is formed of a strut mesh.

21. A prosthetic valve for deployment in a natural valve, the prosthetic valve comprising: Multiple prosthetic valve leaflets; An inner frame that supports the plurality of prosthetic valve leaflets and has a proximal portion and a distal portion; Multiple anchors, the multiple anchors being positioned at the distal portion of the inner frame and adapted to capture the leaflets of the natural valve; A sealing body, the sealing body being positioned radially outward from the inner frame and having a proximal end and a distal end, the distal end being coupled to the distal portion of the inner frame, such that the sealing body is adapted to move relative to the inner frame; and One or more clamping features are positioned on the sealing body and adapted to engage a portion of the natural valve.

22. The prosthetic valve of claim 21, wherein one or more flexible bodies connect the distal end of the sealing body to the distal portion of the inner frame and allow the sealing body to move relative to the inner frame.

23. The prosthetic valve of claim 22, wherein the one or more flexible bodies comprise fabric or shape memory material.

24. The prosthetic valve of claim 22 or claim 23, wherein one or more flexible bodies form a ring positioned at the distal end of the sealing body.

25. The prosthetic valve of any one of claims 22 to 24, wherein the one or more flexible bodies are closedly positioned at the distal end portion of the annular notch between the sealing body and the inner frame.

26. The prosthetic valve of any one of claims 21 to 25, wherein the inner frame extends about a first axis and the sealing body extends about a second axis, and the distal end is coupled to the distal portion of the inner frame such that the sealing body is adapted to tilt relative to the inner frame to deviate the first axis from the second axis.

27. The prosthetic valve of any one of claims 21 to 26, wherein the sealing body is spaced apart from the inner frame by an annular notch, and a fabric bridging member extends from the proximal end of the sealing body to the proximal portion of the inner frame to close the proximal end portion of the annular notch.

28. The prosthetic valve of any one of claims 21 to 27, wherein the one or more clamping features comprise one or more barbs.

29. The prosthetic valve of claim 28, wherein the one or more barbs are positioned for the plurality of anchors to press the natural valve leaflet against the one or more barbs.

30. The prosthetic valve according to any one of claims 21 to 29, wherein the prosthetic valve comprises a prosthetic mitral valve or a prosthetic tricuspid valve.

31. A prosthetic valve for deployment in a natural valve, the prosthetic valve comprising: Valve body; and A plurality of prosthetic valve leaflets are connected to the valve body, each of the plurality of prosthetic valve leaflets comprising: Flowing out of the edge, First side connection end The second side connecting end is positioned opposite to the first side connecting end. Positioned at the center portion between the first side connecting end and the second side connecting end, and An inflow edge positioned relative to the outflow edge, the inflow edge including at least one notch facing the central portion.

32. The prosthetic valve of claim 31, wherein both the first lateral suture end and the second lateral suture end extend axially.

33. The prosthetic valve of claim 31 or claim 32, wherein the at least one notch is concave relative to the central portion.

34. The prosthetic valve of any one of claims 31 to 33, wherein the inflow edge comprises an outer portion, an inner portion, and an intermediate portion between the outer portion and the inner portion, and the outer portion is convex relative to the central portion, the intermediate portion includes at least one notch, and the inner portion is convex relative to the central portion.

35. The prosthetic valve of any one of claims 31 to 34, wherein the at least one notch is positioned along the respective prosthetic valve leaflet at a distance of at least 40% from the outflow edge toward the inflow edge.

36. The prosthetic valve of any one of claims 31 to 35, wherein the inflow edge includes a connecting line.

37. The prosthetic valve of any one of claims 31 to 36, wherein the plurality of prosthetic valve leaflets reduce the size of the new sinus space.

38. The prosthetic valve of any one of claims 31 to 37, wherein the outflow edges of the plurality of prosthetic valve leaflets include an engagement surface.

39. The prosthetic valve of any one of claims 31 to 38, wherein the valve body includes a frame supporting the plurality of prosthetic valve leaflets.

40. The prosthetic valve according to any one of claims 31 to 39, wherein the prosthetic valve comprises a prosthetic mitral valve or a prosthetic tricuspid valve.

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