Transcatheter heart valve with improved blood flow

Abstract

The artificial heart valve includes three artificial leaflets joined together at three commissure regions to form a central passage. A foldable and expandable valve frame is provided to support the artificial leaflets. The valve frame includes three cantilever support arms to support the three commissure regions, with gaps provided between the three cantilever support arms to improve leaflet adhesion and reduce thrombus formation. The valve frame is positioned within an outer seal frame, which is secured to the surrounding cardiac tissue. The artificial heart valve is adapted to be delivered using a minimally invasive transcatheter procedure. The artificial heart valve is preferably used to replace the original mitral or tricuspid valve.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 63 / 470,097, filed May 31, 2023, and U.S. Provisional Application No. 63 / 470,729, filed Jun. 2, 2023, the entire contents of each of which are hereby incorporated by reference herein.

[0002] The specific examples disclosed herein generally relate to implants including artificial valves for transplantation.

Background Art

[0003] Human heart valves include the aortic valve, pulmonary valve, mitral valve, and tricuspid valve, and essentially function as one - way valves that operate in synchronization with the heartbeat of the heart. The valve allows blood to flow downstream, but blocks the upstream flow of blood. Diseased heart valves exhibit disorders such as stenosis or regurgitation of the valve, which inhibit the valve's ability to control blood flow. Such disorders reduce the heart's blood pumping efficiency and can be debilitating and life - threatening conditions. For example, valve insufficiency can lead to symptoms such as heart hypertrophy and ventricular dilation. Therefore, considerable efforts have been made to develop methods and devices for repairing or replacing malfunctioning heart valves.

[0004] Artificial valves exist to correct problems associated with malfunctioning heart valves. For example, mechanical tissue - based artificial heart valves can be used to replace the original malfunctioning heart valve. Recently, a great deal of effort has been devoted to the development of replacement heart valves, particularly tissue - based replacement heart valves that can be delivered to patients with less trauma compared to open - heart surgery. The replacement valves are designed to be delivered by minimally invasive procedures and even percutaneous procedures in some cases. Such replacement valves often include a tissue - based valve body that is connected to an expandable frame and then delivered to the valve annulus of the original valve.

[0005] These replacement valves are often intended to block blood flow, at least partially. However, problems can arise with blood stagnation within or around the replacement valve. For example, stagnation can lead to thrombosis or other disease formation, which can result in stroke or damage to the replacement valve, among other undesirable consequences.

[0006] Furthermore, problems arise when blood flows around the valve outside the prosthesis. For example, with heart valve replacements, paravalvular leakage (PVL), which in the worst cases requires retreatment, has been found to be a particular challenge. An additional challenge concerns the ability to fix such prostheses to intraluminal tissue, such as tissue within any body lumen or cavity, in a non-traumatic manner. Moreover, another unintended consequence of fixing such minimally invasive heart valve replacements within intraluminal tissue is the need to fix them within the heart without causing damage to the heart's original conduction system. [Overview of the Initiative]

[0007] Examples of prosthetic valves target improved blood flow. Improved blood flow leads to a reduction in thrombus formation or other complications associated with the prosthetic valve. Examples include foldable or expandable prosthetic valves configured for transcatheter delivery to the implantation site.

[0008] Preferably, examples include a valve frame that mimics a surgical valve structure (e.g., a surgical ring), as well as a seal frame for fixation and sealing. This combination of configurations allows for more physiological fluid behavior, thereby reducing the need for continuous anticoagulation therapy.

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

[0010] Aspects of the present disclosure include a prosthetic valve for deployment in an original mitral or tricuspid valve. The prosthetic valve comprises three prosthetic leaflets positioned around a flow channel of the prosthetic valve, the three leaflets being mounted to form three commissure regions. The prosthetic valve comprises a valve frame for supporting the prosthetic leaflets, the valve frame being radially expandable from a compression configuration to an expansion configuration, the valve frame comprising three cantilever support arms extending axially to support the three commissure regions, and three openings provided between the three cantilever support arms to reduce thrombus formation and improve leaflet fusion. The prosthetic valve comprises an outer seal frame positioned radially outward of the valve frame, the seal frame engaging with the natural mitral or tricuspid valve.

[0011] Embodiments of this disclosure may include a configuration comprising an artificial heart valve for deployment within the original valve. The artificial heart valve may include a plurality of artificial leaflets. The artificial heart valve may include an inner frame supporting the plurality of artificial leaflets and including a proximal and distal portion. The artificial heart valve may include a plurality of anchors positioned in the distal portion of the inner frame and adapted to capture the original leaflets. The artificial heart valve may include a seal body positioned radially outward from the inner frame and having a proximal end and a distal end connected to the distal portion of the inner frame, adapted to allow the seal body to move relative to the inner frame. The artificial heart valve may include one or more grip configurations positioned on the seal body and adapted to engage with a portion of the original valve.

[0012] Aspects of the present disclosure may include an artificial heart valve for deployment within the original valve. The artificial heart valve may include a valve body. The artificial heart valve may include a plurality of artificial valve leaflets connected to the valve body, each of which comprises an outflow edge, a first lateral commissure end, a second lateral commissure end located opposite the first lateral commissure end, a central portion located between the first and second lateral commissure ends, and an inflow edge located opposite the outflow edge, wherein the inflow edge includes at least one indentation toward the central portion.

[0013] The configurations and advantages of the systems, apparatuses and methods disclosed herein will become clearer as they are better understood by referring to the specification, claims and accompanying drawings. [Brief explanation of the drawing]

[0014] [Figure 1] Figure 1 shows a perspective view of the artificial valve as seen from the outflow side. [Figure 2] Figure 2 shows a perspective view of the artificial valve from the outflow side, rotated from the position shown in Figure 1. [Figure 3] Figure 3 shows the outflow end of the artificial valve shown in Figure 1. [Figure 4] Figure 4 shows a side view of the artificial valve shown in Figure 1. [Figure 5] Figure 5 shows a perspective view of the artificial valve shown in Figure 1, viewed from the inflow side of the artificial valve. [Figure 6] Figure 6 shows a schematic side view of the artificial valve shown in Figure 1. [Figure 7] Figure 7 shows a schematic diagram of the outflow end of the artificial valve shown in Figure 1. [Figure 8] Figure 8 shows a schematic perspective view of the artificial valve shown in Figure 1, viewed from the outflow side of the artificial valve. [Figure 9] Figure 9 shows a perspective view of the support arm in the artificial valve shown in Figure 1. [Figure 10] Figure 10 shows a perspective view of the support arm column. [Figure 11] Figure 11 shows a perspective view of two support arm columns. [Figure 12] Figure 12 shows a side view of the seal frame. [Figure 13] Figure 13 shows a schematic view of the delivery system approaching the implantation site. [Figure 14] Figure 14 shows a schematic cross-sectional view of the delivery system approaching the implantation site. [Figure 15] Figure 15 shows a schematic cross-sectional view of the artificial valve deployed relative to the original valve. [Figure 16] Figure 16 shows a schematic cross-sectional view of the artificial valve deployed relative to the original valve. [Figure 17] Figure 17 shows a schematic cross-sectional view of the artificial valve deployed relative to the original valve. [Figure 18] Figure 18 shows a schematic cross-sectional view of the artificial valve deployed relative to the original valve. [Figure 19] Figure 19 shows a schematic view of the outflow end of the artificial valve. [Figure 20] Figure 20 shows a perspective schematic view of the artificial valve shown in Figure 19. [Figure 21] Figure 21 shows a perspective view of the inflow side of the frame of the artificial valve. [Figure 22] Figure 22 shows a side view of the frame shown in Figure 21. [Figure 23] Figure 23 shows a side view of the frame shown in Figure 21. [Figure 24] Figure 24 shows a side view of the frame shown in Figure 21. [Figure 25] Figure 25 shows a perspective view of the outflow side of the frame shown in Figure 21. [Figure 26] Figure 26 shows a schematic cross-sectional view of the artificial valve. [Figure 27] Figure 27 shows a schematic cross-sectional view of the delivery system approaching the implantation site. [Figure 28] Figure 28 illustrates a schematic cross-sectional view of the artificial valve shown in Figure 26 deployed relative to the original valve. [Figure 29] Figure 29 illustrates a perspective view of the artificial valve. [Figure 30]Figure 30 shows a top perspective view of the artificial valve shown in Figure 29. [Figure 31] Figure 31 shows a schematic cross-sectional view of the artificial valve shown in Figure 29. [Figure 32] Figure 32 shows a schematic cross-sectional view of the artificial valve shown in Figure 29. [Figure 33] Figure 33 shows a schematic cross-sectional view of the artificial valve shown in Figure 29. [Figure 34] Figure 34 shows a perspective view of the frame for the artificial valve. [Figure 35] Figure 35 shows a detailed perspective view of the anchor positioned relative to the artificial valve frame. [Figure 36] Figure 36 shows a detailed side view of the anchor positioned relative to the frame of the artificial valve. [Figure 37] Figure 37 shows a schematic side cross-sectional view of the anchor that presses the original valve leaflet against the frame. [Figure 38] Figure 38 shows a schematic side cross-sectional view of the grip configuration that engages with the original valve leaflet. [Figure 39] Figure 39 shows a schematic side cross-sectional view of the grip configuration that engages with the original valve leaflet. [Figure 40] Figure 40 shows a schematic diagram of the delivery system approaching the transplant site. [Figure 41] Figure 41 shows a schematic side view of the artificial valve shown in Figure 29, unfolded in relation to the transplant site. [Figure 42] Figure 42 shows a perspective view of the artificial valve. [Figure 43] Figure 43 shows a schematic cross-sectional view of the artificial valve shown in Figure 42. [Figure 44] Figure 44 shows a schematic cross-sectional view of the artificial valve. [Figure 45] Figure 45 shows a schematic cross-sectional view of the artificial valve. [Figure 46] Figure 46 shows a schematic cross-sectional view of the artificial valve. [Figure 47] Figure 47 shows a plan view of the artificial valve leaflet. [Figure 48] Figure 48 shows a perspective view of the artificial valve leaflet. [Figure 49]Figure 49 shows a schematic cross-sectional view of the artificial valve. [Figure 50] Figure 50 shows a schematic cross-sectional view of a part of an artificial valve. [Modes for carrying out the invention]

[0015] Figure 1 illustrates a perspective view of an artificial valve 10, which is a form of a replacement heart valve. The artificial valve 10 is configured to deploy within a portion of the patient's body. The artificial valve 10 may include the original mitral valve or the original tricuspid valve, for example, it is configured to deploy within the annulus of the original valve. In several embodiments, other implantation sites may be utilized, such as within the aortic valve or pulmonary valve, or, as desired, within other valves or other locations within the patient's body.

[0016] The artificial valve 10 includes a proximal end 12 (shown in Figure 4) and a distal end 14, as well as the length between the proximal end 12 and the distal end 14. The proximal end 12 is the outflow end of the artificial valve 10, and the distal end 14 is the inflow end of the artificial valve 10. The artificial valve 10 includes a plurality of artificial valve leaflets 16 (e.g., three artificial valve leaflets) configured to surround the flow channel 13 to control the flow through the valve 10. The artificial valve leaflets 16 are configured to transition between open and closed states to mimic and replace the operation of the original valve leaflets.

[0017] The artificial valve leaflet 16 has multiple commissures. For example, as shown in Figure 1, there may be three commissures 26a, 26b, 26c or commissure regions between each artificial valve leaflet 16a, 16b, 16c. The valve leaflet 16 is installed to form three commissures 26a, 26b, 26c or commissure regions. The commissure 26a is located between each artificial valve leaflet 16a, 16b. The commissure 26b is located between each artificial valve leaflet 16b, 16c. The commissure 26c is located between each artificial valve leaflet 16c, 16a. The commissures 26a, 26b, 26c can be spaced evenly apart from each other, or other spacings can be used in multiple embodiments. In multiple embodiments where fewer artificial valve leaflets are used, fewer commissures can be used. For example, there may be two commissures for two artificial valve leaflets. More artificial valve leaflets can utilize more commissures.

[0018] In several embodiments, the artificial valve 10 includes a frame 18. In several embodiments, the frame 18 may include a double frame or a multi-component frame. In several embodiments, the frame 18 may include, for example, a valve frame 20 and a seal frame 22. In several embodiments, other configurations may be used.

[0019] The valve frame 20 is configured to support multiple artificial valve leaflets 16. The valve frame 20 is expandable from a compressed configuration to an expanded configuration by expanding radially. The valve frame 20 is compressible from the expanded configuration to a compressed configuration radially inward. The expanded configuration is shown in Figure 1, but a compressed configuration (shown in Figure 14) can also be used. The compressed configuration is for transcatheter delivery of the artificial valve 10 to the implantation site.

[0020] The valve frame 20 includes one or more support arms in several embodiments. The support arms may include a first support arm 24a that extends axially and is configured to support at least two of a plurality of artificial valve leaflets 16 (artificial valve leaflets 16a, 16b) at a first commissure 26a or commissure region. The support arms may include a second support arm 24b that extends axially and is configured to support at least two of a plurality of artificial valve leaflets 16 (artificial valve leaflets 16b, 16c) at a second commissure 26b or commissure region. In several embodiments, a third support arm 24c extends axially and supports at least two of a plurality of artificial valve leaflets 16 (artificial valve leaflets 16c, 16a) at a third commissure 26c or commissure region. The support arms 24a, 24b, 24c may comprise cantilever support arms in several embodiments. The support arms 24a, 24b, 24c extend axially.

[0021] In multiple embodiments, the support arms 24a, 24b, and 24c are each equidistant from each other in the circumferential direction. Other spacings can be used in multiple embodiments.

[0022] The opening 28a is positioned circumferentially between the first support arm 24a and the second support arm 24b and is configured to allow blood flow through it. The opening 28a has a space between the first support arm 24a and the second support arm 24b, which may extend, for example, from the first support arm 24a to the second support arm 24b. The opening 28a has a flow channel for blood flow. In some embodiments (as shown in Figures 1 and 2), the opening 28a may have a "U" shape or other configurations as desired.

[0023] The opening 28b is located between the support arms 24b and 24c. The opening 28c is located between the support arms 24c and 24a. The openings 28b and 28c may be configured similarly to the opening 28a in some embodiments. The opening 28b may extend from the second support arm 24b to the third support arm 24c. The opening 28c may extend from the third support arm 24c to the first support arm 24a. The three openings 28a, 28b, and 28c are provided between the support arms 24a, 24b, and 24c. The three openings 28a, 28b, and 28c reduce thrombus formation and improve valve leaflet fusion. The openings 28a, 28b, and 28c are substantially unobstructed to allow for improved blood flow through them.

[0024] Each artificial valve leaflet 16a, 16b, and 16c includes a central portion 30 positioned between a first commissure end portion 32 and a second commissure end portion 34. The first commissure end portion 32 is positioned at the respective commissures of adjacent artificial valve leaflets. The second commissure end portion 34 is positioned at the opposite commissures of adjacent artificial valve leaflets.

[0025] In several embodiments, each opening 28a is aligned with the central portion 30 of the prosthetic valve leaflet 16b in the circumferential direction. This position allows blood flow from the radially outward-facing surface of the prosthetic valve leaflet through each opening (e.g., opening 28a). Thus, washout and leaflet adhesion are improved.

[0026] Each support arm 24a, 24b, 24c may extend axially in the outflow direction to its respective free end 33a, 33b, 33c. The free ends 33a, 33b, 33c may include the ends of each support arm 24a, 24b, 24c. The ends 33a, 33b, 33c of the support arms 24a, 24b, 24c may be free and may not be directly connected to one another in some embodiments. In some embodiments, connections between the ends 33a, 33b, 33c are utilized.

[0027] Each support arm 24a, 24b, 24c comprises one or more support arm struts in several embodiments. For example, support arm 24a may be configured to include three support arm struts 36a, 36b, 36c. Support arm strut 36a includes a central strut that extends axially. Support arm strut 36a is positioned between adjacent support arm struts 36b, 36c in the circumferential direction. A perspective view of support arm 24a is shown in Figure 9. Support arm strut 36a includes an outward curved strut to resist inward bending of support arm 24a. Support arm strut 36a is indicated by a radially outward curved portion 38. The distal end 37 of support arm strut 36a includes a connecting portion 40 for connecting to the commissure portion 26a of the artificial valve leaflets 16a, 16b. The proximal end of support arm strut 36a includes a connecting portion 42 for connecting to a portion of the delivery system for the artificial valve. The connecting portion 42 is configured to connect to a portion of the seal frame 22 in several embodiments.

[0028] The curved portion 38 of the support arm column 36a is curved to resist loads (e.g., contraction loads) applied to the artificial valve 10 and valve frame 20 at the joint of the artificial valve leaflet 16. The curvature of the curved portion 38 resists loads on the artificial valve 10 and valve frame 20 that pull the cantilever support arm 24a at the joint. The curved portion 38 includes a bent portion. The shape of the curved or bent portion can be adjusted as desired to change the resistance to loads (e.g., strengthened or reduced). By providing a radially outward curve or bend, the moment of inertia of the support arm 24a can be set to resist radially inward bending. In some embodiments, the resulting support arms 24a, 24b, 24c may be radially flexible.

[0029] The support arm column 36a resists forces applied to the artificial valve 10 and valve frame 20 via connections to the seal frame 22. The proximal end of the support arm column 36a is provided with an inflow support structure that holds the circular inflow of the artificial valve 10. The coupling portion 42 in the artificial valve is connected to the coupling portion 59 at the proximal end 46 of the seal frame 22 (as shown in Figures 4 and 12), for example, to form an inflow support structure that holds the circular inflow of the artificial valve 10. The support arm column 36a extends axially and is aligned with the respective commissures or commissure regions of the artificial valve leaflets in the circumferential direction.

[0030] The support arm supports 36b and 36c are angled toward the central support arm support 36a. The support arm supports 36b and 36c include a single body for coupling with the distal end 37 of the support arm support 36a, or other configurations may be available in multiple embodiments. The support arm supports 36b and 36c have an angle c toward the central support arm support 36a in the direction toward the distal end of the central support arm support 36a.

[0031] The support arm struts 36b and 36c include a connecting portion 41 at their distal end for connecting to the commissure portion 26a of the artificial valve leaflets 16a and 16b, in a similar manner to the connecting portion 40. In several embodiments, the support arm struts 36b and 36c include connecting portions 43a and 43b at their proximal ends for connecting to a portion of the delivery system or a portion of the seal frame 22.

[0032] The support arm posts 36b and 36c are angled toward the central support arm post 36a, forming spaces 45a and 45b spaced circumferentially away from the central support arm post 36a. In several embodiments, the spaces 45a and 45b have a triangular or wedge shape. The spaces 45a and 45b allow the support arm posts 36b and 36c to fold toward the central support arm post 36a in the folding configuration. These features allow the valve frame 20 to move toward the folding configuration. The support arm posts 36b and 36c can bend outward toward the central support arm post 36a as the valve frame 20 moves toward the extended configuration.

[0033] The support arm columns 36a, 36b, and 36c may be made of a self-expanding material in several embodiments. The self-expanding material may include nitinol or other forms of self-expanding material. The support arm columns 36a, 36b, and 36c are constructed by stacking several thin layers of self-expanding material (e.g., nitinol), as shown in Figure 9. Other configurations may be used in several embodiments.

[0034] Figure 10 shows a separate view of a central support arm column 35a, which can be used in a similar manner to the support arm column 36a. Figure 11 shows separate views of angled support arm columns 35b and 35c, which can be used in a similar manner to the support arm columns 36b and 36c. The support arm columns 36b and 36c have a desired "Y" configuration or other fork configuration in several embodiments.

[0035] In several examples, support arms of other configurations can be used. Support arms 24a, 24b, and 24c may each be configured similarly to one another, or in several embodiments, they may have other configurations.

[0036] The support arms 24a, 24b, and 24c can be separated from each other in the circumferential direction and do not need to be directly connected to each other in some embodiments. Direct connection can be used in some embodiments.

[0037] Referring to Figure 1, the seal frame 22 is configured to seal and engage with the original valve. The seal frame 22 includes an outer seal frame 22 that surrounds the valve frame 20 and is positioned radially outward from the valve frame 20. The seal frame 22 is configured to contact and seal with a portion of the original valve (e.g., the original valve leaflet or the valve ring of the original valve). In several embodiments, a seal skirt 39 is positioned on the seal frame 22. The seal frame 22 may include a portion of a seal body for sealing a portion of the original valve. The seal body may include a combination of the seal frame 22 and the seal skirt 39. Other configurations may be used in several embodiments. The outer surface 47 of the seal body can contact a portion of the original valve and seal with the original valve. In several embodiments, the seal skirt 39 may include a fibrous seal skirt. The seal skirt 39 may be positioned on a substantial portion of the seal frame 22.

[0038] The seal frame 22 is expandable radially outward from a compressed configuration to an expanded configuration. The seal frame 22 is compressible radially inward from an expanded configuration to a compressed configuration. The seal frame 22 includes, for example, a lattice structure of columns 49 and openings 51, or a column lattice including a compressible and expandable structure. The lattice structure is configured such that the length of the seal frame 22 increases as the diameter of the seal frame 22 decreases with compression. The length of the seal frame 22 decreases as the diameter of the seal frame 22 increases with expansion to the expanded configuration. Figure 12 shows a separated side view of the seal frame 22.

[0039] Referring to Figure 4, the seal frame 22 includes a proximal portion 53 (or inlet portion), a distal portion 55 (or outlet portion), and a curved 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 inlet end or inlet portion) of the seal frame 22. The seal frame 22 projects radially outward from the valve frame 20. The distal portion 55 extends distally. The curved portion 57 curves to angle the distal portion 55 with respect to the proximal portion 53. The proximal portion 53 of the seal frame 22 is coupled to the proximal portion of the valve frame 20.

[0040] The proximal end 46 of the seal frame 22 includes one or more connecting portions 59 for connecting to the connecting portions 42, 43a, and 43b of the support arm, as shown in Figure 9. These connections form a connection between the seal frame 22 and the valve frame 20. In several embodiments, other forms of connections may be used. In several embodiments, the connecting portion 59 may be used to connect to a portion of the delivery system. The connecting portion 59 may, for example, include an eyelet or other form of connecting portion for connecting to sutures or other connectors of the delivery system. In several embodiments, other forms of connections may be used.

[0041] The connecting portion 59 is positioned at the proximal end of the support column 49 of the seal frame 22. Each connecting portion 59 is connected to one of the connecting portions 42, 43a, and 43b of the support arm, respectively. For example, in the example shown in Figure 1, nine support arm columns are used. Nine corresponding connecting portions 59 can be used (for example, as shown in Figure 4). The connecting portions 59 are spaced apart circumferentially from each other in adjacent groups (for example, three groups) of connecting portions 59 used for each support arm 24a, 24b, and 24c.

[0042] Referring to Figure 1, the seal frame 22 surrounds the valve frame 20. The seal frame 22 surrounds, for example, the first support arm 24a and the second support arm 24b. In embodiments where a third support arm 24c is used, the seal frame 22 may surround the third support arm 24c. In some embodiments, the outlet end of the seal frame 22 may be located further downstream than the outlet end of the valve frame 20. In some embodiments, the outlet end of the valve frame 20 may be located further downstream than the outlet end of the seal frame 22.

[0043] The seal frame 22 is separated from the valve frame 20 by a gap 48. The gap 48 extends around the valve frame 20, forming a ring with an annular shape. The gap 48 contains space from the valve frame 20 that allows blood flow through it. The inner surface 61 of the seal frame 22 faces the gap 48. The outlet ends of the valve frame 20 are separated radially from the outlet ends of the seal frame 22 to provide a gap 48 between them. The outlet ends of the valve frame 20 do not contact the outlet ends of the seal frame 22, and a gap is provided between them.

[0044] The distal portion 55 or outlet portion of the seal frame 22 is spaced apart from the valve frame 20, forming an opening 50 inside the seal frame 22. The interior of the seal frame 22 includes a gap 48 or annular ring extending around the valve frame 20. In this way, blood can flow through the opening 50 into the gap 48. The seal frame 22 has a concave shape toward the ventricle when deployed to allow blood to flow in a funnel shape toward the valve frame 20 and the prosthetic valve leaflet 16.

[0045] Figure 2 shows a perspective view of the artificial valve 10 rotated from the position shown in Figure 1. Figure 3 shows a view of the distal end or outflow end of the artificial valve 10. Figure 4 shows a side view of the artificial valve 10. Figure 5 shows a view of the proximal end or inflow end of the artificial valve 10.

[0046] Figure 6 shows a schematic diagram of the artificial valve 10. Figure 7 shows a schematic diagram of the distal end or outflow end of the artificial valve 10.

[0047] Referring to Figure 8, the openings 28a, 28b, 28c between the adjacent support arms 24a, 24b, 24c allow blood flow to pass through, thereby reducing the spread of stagnant blood flow radially outward of the prosthetic valve leaflets 16a, 16b, 16c. As shown by the flow arrow 52 in Figure 8, blood passes through the respective openings 28a, 28b, 28c along the radially outward-facing surfaces of the prosthetic valve leaflets 16a, 16b, 16c. The openings 28a, 28b, 28c provide flow channels for blood flow. Blood flows through and out of a gap 48 located between the valve frame 20 and the seal frame 22. The seal frame 22 preferably has a smooth inner surface that reorients the flow and promotes complete washout when the prosthetic valve leaflets are in the closed position.

[0048] Reducing the prevalence of stagnant blood flow can reduce thrombus or other disease formation in the radially outward direction of the valve leaflet 16 or in the gap 48 of the seal frame 22. This results in improved hemodynamics. Furthermore, the prosthetic valve 10 is foldable or expandable to allow transcatheter delivery.

[0049] The valve frame 20 mimics a surgical valve structure (e.g., a surgical ring). The seal frame 22 provides fixation and sealing. This combination of configurations allows for more physiological fluid behavior, thereby reducing the need for continuous anticoagulation therapy. The advantage of low thrombosis in bioprosthetic surgical valves is mimicked. The prosthetic valve leaflets 16 are suspended in free space (rather than being covered by a cylindrical structure). This type of structure reduces the possibility of thrombus formation due to open flow channels between the support arms 24a, 24b, and 24c. The shape of the seal frame 22 reduces the spread of turbulence or coagulation and allows for washout during opening and closing of the prosthetic valve leaflets.

[0050] In several embodiments, one or more anchors 54 (as shown in Figure 15) are used to secure the artificial valve 10 to the implantation site. For example, referring to Figure 15, the anchor 54 comprises a curved, elongated anchor or hook configured to hook around the original valve leaflet 56 and be positioned radially outward from the original valve leaflet 56. The anchor is shaped to extend over the distal tip of the original valve leaflet 56 of the original valve 58. In several embodiments, the anchor 54 may extend from the valve frame 20. For example, in several embodiments, the anchor 54 may extend from one of the support arms 24a, 24b, and 24c. In several embodiments, the anchor may extend from other parts of the artificial valve 10. The anchor 54 is adapted to capture the original valve leaflet between the anchor 54 and the seal frame 22. The anchor 54 is adapted to bend during deployment from an elongated configuration to a hooked, curved, or bent configuration, for example, as shown in Figure 15.

[0051] Figures 13-15 show exemplary deployment procedures for the artificial valve 10. Referring to Figure 13, the delivery device 60 can be accessed through a passage through the patient's vascular structure to reach the implantation site. Transcatheter deployment can be used in multiple embodiments. In multiple embodiments, the delivery device 60 can be delivered transvenously through the femoral vein 62 or through another delivery approach.

[0052] The delivery device 60 can access the implantation site transvenously. For example, the delivery device 60 can access the right atrium 63 for deployment to the tricuspid valve. In several embodiments, the delivery device 60 can advance through the septum to the left atrium 65 for deployment to the mitral valve. Figure 13 shows advancement to the mitral valve, but advancement to the tricuspid valve can also be utilized. In several embodiments, other approaches can be used for other implantation sites.

[0053] Referring to Figure 14, the artificial valve 10 is held in a compressed configuration within the delivery device 60 in several embodiments. For example, a capsule 64 or other form of retaining body can hold the artificial valve 10 in a compressed configuration. The artificial valve 10 may include a self-expanding artificial valve 10 that expands when released by the retaining body (such as the capsule 64). The frame 18 of the artificial valve 10 (including the valve frame 20 and the seal frame 22) is self-expanding. The frame 18 can be made of a shape memory material that generates self-expansion. In several embodiments, the shape memory material may be nitinol or another form of shape memory material.

[0054] In several embodiments, the artificial valve 10 may be configured to be delivered with an inflatable body, such as a balloon or other form of deployment. The inflatable body is positioned inside the artificial valve 10 and inflates to expand the artificial valve 10 into an expanded configuration.

[0055] Figure 14 shows the artificial valve 10 in a compressed, elongated configuration, in which the anchor 54 and seal frame 22 are elongated and have a reduced diameter from the deployed configuration. The capsule 64 can deflate and release the artificial valve 10 from the compressed configuration, or other forms of deployment can be utilized in several embodiments.

[0056] Figure 15 shows the deployed artificial valve 10. The anchor 54 is hooked onto the original valve leaflet 56. Blood flow can flow through the respective openings 28a, 28b, and 28c, as shown, for example, in Figure 8. This results in improved hemodynamics.

[0057] In several embodiments, other forms of artificial valves may be used. In several embodiments, other forms of anchoring may be used.

[0058] Figure 16 shows, for example, a variation of the artificial valve 10 in which the anchor 66 extends from the seal frame 22. The valve frame 20 lacks an anchor directly connected to the valve frame 20 and can therefore have an appearance such as that shown in Figure 1.

[0059] Figure 17 shows a variation in which one or more anchors 68 include barbs extending radially outward from the seal frame 22. The anchors 68 may be positioned on the seal frame 22 (e.g., the outer surface of the seal frame 22) or on the valve frame 20, and may extend radially outward from the valve frame 20 and through the seal frame 22. The anchors 68 reinforce the anchoring to the original valve.

[0060] Figure 18 shows a variation in which the seal frame 22 forms one or more flanges 70, 72 for securing the prosthetic valve to the original valve. A proximal flange or atrial flange 70 may be used, and a distal flange or ventricular flange 72 may be used. A recess 74 is formed between the proximal flange or atrial flange 70 and the distal flange or ventricular flange 72 to hold a portion of the original valve for fixation. In some embodiments, the seal frame 22 may have an hourglass shape or another shape.

[0061] Other variations of the artificial valve 10 can be provided. Figure 19 illustrates, for example, a variation in which one or more flow barriers 80 are positioned within the gap 48. The flow barriers 80 are spaced apart from each other circumferentially and are positioned radially outward from one of each of the support arms 24a, 24b, and 24c. The flow barriers 80 extend radially outward from one of each of the support arms 24a, 24b, and 24c relative to the seal frame 22. In some embodiments, the flow barriers 80 extend radially outward from a central support arm column 36a (for example, as shown in Figure 9). The flow barriers 80 are coupled to the central support arm column 36a and extend radially outward relative to the seal frame 22. In some embodiments, the flow barriers 80 can cover the curved portion 38 of the support arm column 36a, or other configurations can be utilized. Three flow barriers 80 may be provided, but fewer or more may be utilized as desired.

[0062] The flow barrier 80 is positioned to reduce the possibility of blood stagnation in the radially outward direction of one of the support arms 24a, 24b, and 24c. The portion of the gap 48 that forms a partial ring around the valve frame 20 allows blood flow through it between the flow barriers 80. Three separate regions within the seal frame 22 are provided for improved washout. The flow barrier 80 may have a wedge shape or a tapered shape, as shown in Figures 19 and 20. The wedge shape or tapered shape increases in width in the radially outward direction. In several embodiments, other shapes may be used as desired.

[0063] The configurations shown in Figures 1 to 20 may be used individually or in combination with any other examples disclosed herein.

[0064] In multiple embodiments, various other configurations of the artificial valve can be utilized.

[0065] Figure 21 shows, for example, the configuration of the frame of an artificial valve in which the valve frame 90 holds the artificial valve leaflets 92 in a sub-annular shape. The valve frame 90 can be configured similarly to the valve frame 20 and includes a plurality of support arms 94a, 94b, 94c, each extending axially. The support arms 94a, 94b, 94c are positioned at the commissure or commissure region of adjacent artificial valve leaflets 92. The openings 95a, 95b, 95c are positioned between each adjacent support arm 94a, 94b, 94c. The support arms 94a, 94b, 94c may include cantilever support arms in some embodiments. The support arms 94a, 94b, 94c extend axially to support the commissure region of adjacent artificial valve leaflets 92. The support arms 94a, 94b, 94c support the commissure region of the artificial valve leaflets 92. The openings 95a, 95b, and 95c are positioned between their respective adjacent support arms 94a, 94b, and 94c to reduce thrombus formation and improve leaflet fusion. The openings 95a, 95b, and 95c are substantially unobstructed to allow for improved blood flow through them.

[0066] Figure 23 shows a side view of the valve frame 90 opposite to that shown in Figure 21. The support arms 94a, 94b, and 94c are connected to connecting struts 97 that extend along the inlet edges 99 of the respective artificial valve leaflets 92. The connecting struts 97 are angled to form a Y-shape or fork shape adjacent to the support arms 94a, 94b, and 94c. The connecting struts 97 extend to a connecting section 101 at the central portion of the openings 95a, 95b, and 95c of the valve frame 90, which can be used to connect to an anchor frame 96.

[0067] In several embodiments, the anchor frame 96 includes a column 98 or a column grid and a grid structure of the opening 100. The anchor frame 96 may have a cylindrical shape as shown in Figure 21 or another desired shape. The anchor frame 96 and the valve frame 90 may each be configured in a compression configuration or an expansion configuration. Transcatheter delivery may be utilized.

[0068] In several embodiments, the valve frame 90 is coupled 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 at the inlet portion or inlet end of the valve frame 90. In several embodiments, the anchor frame 96 can be modularly coupled to the valve frame 90. The anchor frame 96 can be removed from the valve frame 90 as needed. In this way, various other configurations of the valve frame and anchor frame can be made interchangeable as desired. Various combinations of the valve frame and anchor frame can be used to address the size or type of graft site (e.g., mitral valve graft versus tricuspid valve). Valve frames 90 of different sizes can be modularly coupled to the anchor frame 96 as needed. Different types of valve frames 90 (e.g., two prosthetic leaflets versus three prosthetic leaflets) can be made modular. The coupling portion 101 shown in Figure 23 includes, for example, an eyelet that allows for suture connection or other forms of modular connection with the anchor frame 96.

[0069] In several embodiments, one or more anchors 104 are connected to an anchor frame 96 and project radially outward from the anchor frame 96. The anchors 104 may have hooks as disclosed herein or have other configurations. The anchors 104 may be curved and elongated anchors and may be adapted to capture the original valve leaflets between the anchor 104 and the seal frame 106 (as shown in Figure 26). The anchors 104 may be adapted to bend during deployment from an elongated configuration to a hooked, curved, or bent configuration, for example, as shown in Figure 28.

[0070] The anchor frame 96 can be used to withstand the anchor load rather than having it directly applied to the valve frame 90. The anchor 104 moves the original valve leaflet proximal to the prosthetic leaflet or to the atrium, providing open space for blood flow.

[0071] Figure 22 shows a side view of the valve frame 90 coupled to the anchor frame 96. Figure 23 shows a side view of the valve frame 90. Figure 24 shows a side view of the anchor frame 96. Figure 25 shows a distal or outflow perspective view of the valve frame 90 connected to the anchor frame 96.

[0072] The anchor frame 96 is positioned to project from the valve frame 90 in the inflow or proximal direction. The anchor frame 96 exposes the openings 95a, 95b, and 95c between the support arms 94a, 94b, and 94c, allowing blood flow through them.

[0073] In several embodiments, the seal frame 106 is connected to and surrounds the anchor frame 96. The seal frame 106 includes an outer seal frame 106 positioned radially outward from the valve frame 90. Figure 26 shows a typical position of the seal frame 106. The seal frame 106 can be configured similarly to the seal frame 22. The seal frame 106 is configured to engage with the original valve. The proximal or inlet portion of the seal frame 106 is connected to the proximal or inlet portion of the anchor frame 96. The seal 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 seal frame 106. In several embodiments, the outlet end of the valve frame 90 may be positioned further downstream than the outlet end of the seal frame 106. Therefore, the openings 95a, 95b, and 95c of the valve frame 90 are not covered by the seal frame 106 in order to allow further blood flow through the openings 95a, 95b, and 95c. The openings 95a, 95b, and 95c form blood flow pathways that are not covered by the seal frame 106. The anchors 104 of the anchor frame 96 are positioned proximal or in the inflow direction from the blood flow pathways of the openings 95a, 95b, and 95c. The artificial valve leaflets are positioned in an open space (rather than in an enclosed structure) to improve blood flow. In several embodiments, the seal frame may be configured to include a seal skirt, which may include a fibrous seal skirt or other forms of skirt. The seal skirt may be positioned over a substantial portion of the seal frame 106.

[0074] The outlet end of the valve frame 90 is spaced radially away from the outlet end of the seal frame 106 to provide a gap between them. The outlet end of the valve frame 90 does not contact the outlet end of the seal frame 106, and a gap is provided between them.

[0075] Figures 27 and 28 show typical configurations of the prosthetic valve in deployment. Figure 27 shows the prosthetic valve in a compressed or undeployed configuration within a capsule of a delivery system. The prosthetic valve can be released from the capsule to position the prosthetic valve in the deployed configuration shown in Figure 28. The prosthetic valve may be a self-expanding prosthetic valve that expands upon release by a retaining body (such as a capsule). The frame of the prosthetic valve (including the valve frame 90, anchor frame 96, and seal frame 106) is self-expanding. The frame may be made of a shape memory material that generates self-expansion. In several embodiments, the shape memory material may be nitinol or another form of shape memory material.

[0076] In several embodiments, the artificial valve may be configured to be delivered by an inflatable body, such as a balloon or other form of deployment. The inflatable body is positioned inside the artificial valve and inflates to expand the artificial valve into an expanded configuration.

[0077] The valve frame 90 may be sub-annular and positioned distal to the anchor 104 and seal frame 106. The valve frame 90 is positioned within the original ventricle after deployment. The openings 95a, 95b, and 95c shown in Figures 21 and 23 are not covered by the seal frame 106 and allow blood flow through them. This results in a reduced prevalence of blood stasis. In several embodiments, the position of the valve frame 90 can be varied to position it annularly relative to the original valve. For example, the valve frame 90 can be positioned at the proximal or inflow end portion of the anchor frame 96 for annular positioning. The openings 95a, 95b, and 95c provide open flow channels not covered by the anchor frame 96 and seal frame 106. The prosthetic leaflets are positioned in an open space (rather than in an enclosed structure) to improve blood flow.

[0078] The valve frame 90 mimics a surgical valve structure (e.g., a surgical ring). The seal frame 106 provides sealing, and the fixation frame 96 provides fixation. This combination of configurations allows for more physiological fluid behavior, thereby reducing the need for continuous anticoagulation therapy. The advantage of low thrombosis of bioprosthetic surgical valves is mimicked. The prosthetic valve leaflets 92 are suspended in free space (rather than being covered by a cylindrical structure). This type of structure reduces the possibility of thrombus formation due to open flow channels between the support arms 94a, 94b, and 94c. The position of the prosthetic valve leaflets 92 in open space reduces the spread of turbulence or coagulation outside the prosthetic valve leaflets 92.

[0079] The configurations shown in Figures 21 to 28 may be used individually or in combination with any other examples disclosed herein.

[0080] In multiple embodiments, various other configurations of the artificial valve can be utilized.

[0081] Figure 29 shows a perspective view of an artificial valve 210 in the form of a replacement heart valve. The artificial valve 210 may be configured to be deployed within a portion of the patient's body. The artificial valve 210 may include the original mitral valve or the original tricuspid valve, for example, it may be deployed in the annulus of the original valve. In some embodiments, other implantation sites may be the inside of the aortic valve or pulmonary valve, or other valves or other locations within the patient's body as desired.

[0082] The artificial valve 210 may include a proximal end 212, a distal end 214 (shown in Figure 31), and a length extending between the proximal end 212 and the distal end 214. The artificial valve 210 may further include a plurality of artificial valve leaflets 216 (shown in Figure 30) configured to surround a flow channel 217 for controlling the flow passing through the valve 210. The artificial valve leaflets 216 may be configured to move between open and closed positions to mimic and replace the operation of the original valve leaflets.

[0083] In several embodiments, the artificial valve leaflets 216 may be directly connected 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 seal body 211.

[0084] The inner frame 218 or valve frame may support a plurality of artificial valve leaflets 216. The inner frame 218 may have a proximal portion 222 and a distal portion 224 (as shown in Figure 31) and may extend along the first axis 226. The inner frame 218 may include a skirt 228 connected thereto. The inner frame 218 may surround a flow channel 217.

[0085] The inner frame 218 may be contoured in several embodiments such that the proximal portion 222 of the inner frame 218 has a larger diameter than the distal portion 224 of the inner frame 218. The inner frame 218 may be contoured to curve radially outward in the direction from the distal portion 224 toward the proximal portion 222 (as shown in Figure 31). The inner frame 218 may be curved or other configurations may be utilized so that the proximal portion 222 has a larger diameter than the distal portion 224. Other configurations of the inner frame 218 may be utilized in several embodiments. For example, the inner frame 218 may have a cylindrical shape with a uniform diameter from the proximal portion 222 toward the distal portion 224, or it may have a curved contour shape where the distal portion 224 has a larger diameter than the proximal portion 222. The proximal portion 222 of the inner frame 218 may widen radially outward in the direction from the distal portion 224 toward the proximal portion 222. In some embodiments, other configurations of the inner frame may be used.

[0086] Multiple artificial valve leaflets 216 can be connected to the inner frame 218. For example, multiple artificial valve leaflets 216 can be connected via connecting lines 230, or suture lines, that can connect multiple artificial valve leaflets 216 to the skirt 228. In some embodiments, the artificial valve leaflets 216 may have other forms of connection.

[0087] Multiple anchors 232 may be positioned on the distal portion 224 of the inner frame 218 and may be configured to capture the leaflets of the original valve. The anchors 232 may, in particular, be configured to anchor to the original leaflets of the patient's heart. The anchors 232 can anchor to the original leaflets by extending around them. The anchors 232 may be configured to be positioned radially outward of the outward-facing surface 234 of the original valve leaflets 236, for example, as shown in Figure 41. The anchors 232 include distal anchors positioned at the distal end 214 of the valve 210, or, in some embodiments, may be positioned at other locations as desired.

[0088] Each of the anchors 232 may extend radially outward from the flow channel 217 and radially outward from the artificial valve leaflets 216 of the valve 210. Referring to Figure 31, the anchors 232 may be coupled to the distal portion 224 of the inner frame 218. Each of the anchors 232 includes a proximal portion 238 and a distal portion 240, the proximal portion 238 being coupled to the inner frame 218 and the distal portion 240 including the corresponding tip of the anchor 232. When the valve 210 is deployed, the anchors 232 may extend proximally, perpendicular to the tip of the distal portion 240.

[0089] As shown in Figure 31, each anchor 232 may be configured as a projecting arm that extends distally and then curves proximally toward the corresponding tip of the anchor 232. This configuration allows the anchor 232 to extend around the original valve leaflet and around the distal tip of the leaflet, hooking onto the distal end of the original valve leaflet and securing the leaflet between the anchor 232 and the seal body 211. The anchor 232 may be positioned radially outward from the outward-facing surface of the original valve leaflet. Thus, the anchor 232 can resist forces applied to the valve 210 in the atrial direction, i.e., proximal direction, and can anchor the valve 210 within the annulus of the original valve. The anchor 232 may be configured to hold the original valve leaflet between the anchor 232 and the seal body 211. In some embodiments, other configurations relating to the anchor 232 may be used as desired.

[0090] In Figures 29 to 33, anchor 232 is shown in an expanded configuration, i.e., an extended configuration, with its tip extending proximal. In some embodiments, anchor 232 may be configured in an unexpanded configuration, i.e., an unextended configuration, i.e., a linear configuration, with its tip extending distally. During deployment, anchor 232 may be configured to transition radially outward from the unexpanded configuration to the deployed configuration, in which case the tip reverses proximal. Such an operation may allow anchor 232 to reverse onto the original valve leaflet and anchor to the original valve leaflet during deployment. In some embodiments, other deployment methods for anchor 232 may be used as desired.

[0091] The seal body 211 may be positioned radially outward of the inner frame 218 and may have a proximal end 242 and a distal end 244 connected to the distal portion 224 of the inner frame 218, so as to be configured to move relative to the inner frame 218. In some embodiments, the artificial valve 210 may include one or more flexible bodies 246, the distal end 244 of the seal body 211 connected to the distal portion 224 of the inner frame 218, and enabling the seal 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 seal body 211. One or more flexible bodies 246 may be shaped as arms in some embodiments or may have other shapes as desired. One or more flexible bodies 246 may include textiles or shape memory materials (such as nitinol) in some embodiments or may have other configurations as desired. The seal body 211 and the inner frame 218 may not have a direct connection to each other. One or more flexible bodies 246 may connect the seal body 211 to the inner frame 218.

[0092] In several embodiments, one or more flexible bodies 246 may form a cover over the distal end of the gap 248 between the inner frame 218 and the seal body 211. One or more flexible bodies 246 may close the distal end portion of the gap 248 located between the seal body 211 and the inner frame 218. One or more flexible bodies 246 may form a ring located at the distal end 244 of the seal body 211, for example, connecting the distal end 244 of the seal body 211 to the distal portion 224 of the inner frame 218. The annular ring may form a seal over the distal end 244 of the seal body 211 so as to prevent fluid from flowing through one or more flexible bodies 246 into the gap 248.

[0093] The seal body 211 may be configured to seal a portion of the patient's heart valve. The seal body 211 may include a frame (which may be an outer frame) 220 and a seal skirt 250, but other configurations may be used as desired. The seal body 211 may be tapered radially inward from the proximal end 242 toward the distal end 244, but other configurations may be used as desired. The proximal end portion of the seal body 211 may extend radially outward from the distal end 244 toward the proximal end 242 of the seal body 211. The seal body 211 may extend around a second axis 252.

[0094] The seal body 211 may be separated from the inner frame 218 by a gap 248. The gap 248 may include an annular gap in several embodiments. The proximal end 242 of the seal body 211 may form an opening for the gap 248. The gap 248 may be closed at the distal end 244 of the seal body 211. For example, the flexible body 246 may include a closure portion of the space between the distal end 244 of the seal body 211 and the inner frame 218. In embodiments in which the flexible body 246 includes a fabric material, the fabric material may, for example, form a seal at the distal end 244 of the seal body 211.

[0095] The distal end 244 of the seal body 211 may be coupled to the distal portion 224 of the inner frame 218 so that the seal body 211 may be configured to move axially relative to the inner frame 218. For example, the seal body 211 may move distally along axis 226 or proximal along axis 226 relative to the inner frame 218. In some embodiments, the distal end 244 of the seal body 211 may be coupled to the distal portion 224 of the inner frame 218 so that the seal 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.

[0096] Figure 32 illustrates, for example, the inclination of the seal body 211 relative to the inner frame 218. In several embodiments, either the seal body 211 or the inner frame 218 may be inclined. In several embodiments, the inner frame 218 may be inclined while the seal body 211 remains stationary. The inner frame 218 is inclined, but the seal body is not, thus maintaining optimal sealing. The second axis 252 is offset from the first axis 226. The flexible body 246 is deflected so that the seal body 211 can move relative to the inner frame 218.

[0097] Figure 33 illustrates the axial movement of the inner frame 218 relative to the seal body 211. It is shown that the seal body 211 moves proximal to the inner frame 218, with one or more flexible bodies 246 deflected to enable this movement. Combinations of inclined and axial movement may be used in multiple embodiments.

[0098] The above movement may be used to adapt to deployments in which the chordae tendineae or papillary muscles or septal margin column of the ventricle can be captured by the anchor 232 or another part of the prosthetic valve. In this way, the inner frame 218 can tilt or move axially to the position of capture, while the seal body 211 can remain stationary and in an optimal axial position to prevent extravalvular leakage (PVL). Other advantages may be provided by the movement.

[0099] In some embodiments, the artificial valve 210 may include one or more grip configurations. The grip configurations may have various forms. Referring to Figure 34, for example, grip configurations 254, 256, and 258 may be positioned on the seal body or on the outer frame 260 of the seal body. The configuration of the outer frame 220 may be used together with the outer frame 260 unless otherwise specified. The grip configurations 254, 256, and 258 may be adapted to engage with a portion of the original valve.

[0100] The outer frame 260 may include a plurality of posts 262 that border the openings 264, 266 of the outer frame 260. In several embodiments, the posts 262 may form a grid configuration or a post grid. The posts 262 may form closed cells that border the opening 264, or they may form open cells that border the opening 266. For example, the posts 262 may include posts 262a to 262d that can border the opening 264a. The opening 266 does not have to be surrounded by posts on a portion of the opening 266 (for example, the opening 266 may be in the distal portion of the outer frame 260, or it may form the most distal opening 266 of the outer frame 260). In embodiments, the grip configurations 254, 256, 258 may extend toward at least one of the plurality of openings 264, 266 of the outer frame 260.

[0101] In several embodiments, the opening 266 may be aligned with the position of one or more anchors 232 in the circumferential direction. Referring to Figure 35, for example, the opening 266 may include an opening 266a that can be bounded by columns 262a, 262e. The opening 266a may be aligned with the anchors 232 in the circumferential direction so that the anchors 232 can be positioned in the opening 266a. Figure 36 illustrates, for example, the circumferential alignment of the anchors 232 with respect to the opening 266a. The tip of the anchor 232 may be positioned in the opening 266a.

[0102] In some embodiments, the multiple support columns 262 may include distal tips 263 that can extend radially outward.

[0103] In several embodiments, the grip configuration 254 may include grip configurations 254a, 254b that can be positioned at the location of the anchor 232. The grip configurations 254a, 254b may be configured to engage with the surface of the original valve at the location of the anchor 232. The grip configurations 254a, 254b may be positioned, for example, so that the anchor 232 can press the original valve against the grip configurations 254a, 254b. The anchor 232 can push the original valve against the grip configurations 254a, 254b to reduce the possibility of movement of the original valve relative to the outer frame 260. The anchor 232 can grip the valve leaflets with the grip configurations 254a, 254b, for example, by pressing the valve leaflets against the seal body and against the grip configurations 254a, 254b. In several embodiments, the grip configurations 254a, 254b may extend axially or extend radially outward. In this embodiment, other configurations may be used.

[0104] Figure 37 shows an exemplary schematic cross-sectional view of the valve leaflet 236 positioned relative to the grip configuration 254b. The anchor 232 can press the valve leaflet 236 against the grip configuration 254b, thereby engaging the grip configuration 254b with the valve leaflet 236. The valve leaflet 236 may be deflected radially inward or bent at the contact point between the grip configuration 254b and the anchor 232. Inward deflection can enhance the engagement between the grip configuration 254b and the valve leaflet 236, further securing the valve leaflet 236 to the grip configuration 254b.

[0105] In several embodiments, one or more grip configurations 254 may be used. Referring to Figure 34, in several embodiments, the grip configurations 254 may be spaced apart circumferentially so as to be positioned at the location of the anchor 232. In several embodiments, other positions of the grip configurations 254 may be utilized.

[0106] The grip configuration 254 can reduce the movement of the valve leaflets 236 relative to the seal body 211. The grip configuration 254 can strengthen the fixation of the prosthetic valve to the implantation site. The grip configuration 254 can, for example, engage with one or more of the valve leaflets 236 to reduce the possibility of proximal or distal movement of the outer frame 260 relative to the valve leaflets 236, and fix the orientation of the outer frame 260 to the implantation site. The grip configuration 254 can reduce the movement of the valve leaflets 236 relative to the seal body 211. The grip configuration 254 can resist distal movement of the prosthetic heart valve.

[0107] The grip configuration 254 may be engageable in several embodiments as a result of the deployment procedure of the anchor 232. For example, the anchor 232 may extend linearly distally during the deployment procedure and may be reversed to extend proximal in the deployed configuration (as shown, for example, in Figures 29 and 41). The anchor 232 may be reversed to press against the grip configuration 254 and secure the valve leaflet 236 to the grip configuration 254. The anchor 232 may be linearly extended and the valve leaflet 236 released from the grip configuration 254 by utilizing a recapture or repositioning procedure. Thus, the grip configuration 254 can be selectively engaged or disengaged by controlling the position of the anchor 232.

[0108] In some embodiments, other forms of grip configurations may be used.

[0109] The grip configuration 256 may be configured to engage with, for example, a portion of the original valve located proximal to the grip configuration 254. In several embodiments, the grip configuration 256 may be located proximal to the grip configuration 254 on the outer frame 260. The grip configuration 256 may be located on one or more of the support columns 262 and may extend toward one or more of the openings 264. The grip configuration 256 may be located on a closed support column cell, or may be located at other locations as desired.

[0110] The grip configuration 256 may be configured to engage with the proximal portion of the valve leaflet 236, or with the annular portion of the original valve. Figure 38 shows, for example, the grip configuration 256 engaging with a portion of the valve leaflet 236. In some embodiments, other locations of engagement (e.g., a portion of the annular portion of the original valve, or another desired portion) may be utilized. In some embodiments, the grip configuration 256 may extend axially or extend radially outward.

[0111] In some embodiments, other forms of grip configurations may be used.

[0112] The grip configuration 258 may be configured to engage with a portion of the original valve in response, for example, if one or more of the anchors 232 fail to capture the valve leaflet 236. The grip configuration 258 may be configured such that the contact between the grip configuration 258 and the valve leaflet 236 extends radially outward, allowing the grip configuration 258 to engage with the valve leaflet 236. Figure 39 shows, for example, such a configuration. An anchor 232 has failed to capture the valve leaflet 236. Therefore, the anchor 232 is positioned radially inward of the uncaptured valve leaflet 236. The grip configuration 258 may engage with the surface of the original valve leaflet if the anchor 232 fails to capture the valve leaflet 236. The grip configuration 258 may project radially outward from the anchor 232 and engage with the inner surface of the valve leaflet 236. Therefore, the grip configuration 258 can fix the outer frame 260 in position relative to the valve leaflet 236 and prevent proximal or distal movement of the outer frame 260 relative to the valve leaflet 236. The outer frame 260 can form a seal with the valve leaflet 236 to reduce the possibility of fluid flowing radially outward of the outer frame 260 and radially outward of the artificial valve (e.g., valve leakage).

[0113] The grip configurations 254, 256, and 258 can have various configurations. In several embodiments, the grip configurations 254, 256, and 258 may have barbs and be configured to penetrate and engage with the tissue of the original heart valve (e.g., the leaflets of the original heart valve). The barbs may extend distally or, in several embodiments, may have other orientations. In several embodiments, other configurations of the grip configurations 254, 256, and 258 may be utilized.

[0114] Figures 40 and 41 show an exemplary deployment sequence of the artificial valve 210. The artificial valve 210 may include any of the features disclosed with respect to Figures 29 to 39, including the use of one or more grip configurations. A delivery device 268 may be used to access the implantation site. The delivery device 268 may be inserted percutaneously into the patient's body in a minimally invasive manner. In other embodiments, more invasive means may be used as desired.

[0115] The delivery device 268 may be used for transcatheter delivery of the valve. The delivery device 268 may advance transvenously through the femoral vein 270 or another part of the patient's vascular system. For example, transjugular access or other methods of access may be used as desired. The delivery device 268 may reach the patient's heart 272.

[0116] The delivery device 268 may be used to deliver a valve to the tricuspid valve and may therefore be positioned within the right atrium 274 of the patient's heart for delivery to the tricuspid valve. In embodiments where delivery is to the mitral valve, the delivery device 268 may advance through the septum into the left atrium 276 for delivery to the mitral valve. The delivery device 268 may advance toward the left ventricle 278 of the patient's heart for delivery of the mitral valve.

[0117] The artificial valve 210 may be held in a compressed or undeployed configuration within the capsule 280 of the delivery device 268. At the implantation site, the artificial valve 210 may be released from the capsule 280. Figure 41 illustrates the deployed configuration of the artificial valve. The anchor 232 may be released from the capsule 280, which is located radially outward from the original valve leaflet 236. The seal body 211 may be released from the capsule 280, extending radially outward and in contact with the original valve (e.g., the inward-facing surface of the original valve leaflet 236). In some embodiments, one or more of the grip configurations 254, 256, and 258 may be used to fix the seal body 211 in a desired position relative to the original valve (e.g., relative to the original valve leaflet 236).

[0118] The inner frame 218 can be connected to the seal body 211 by one or more flexible bodies 246. Thus, the inner frame 218 can be tilted or moved axially relative to the seal body 211 to conform to the desired shape of the graft site. This can result in improved sealing and / or remodeling of the original valve.

[0119] In several embodiments, the outer frame 260 of the seal body 211 may be adaptable to allow the outer frame 260 to conform to the shape of the original valve. For example, an original valve having an irregular or "D" shape may conform to the outer frame 260. While the outer frame 260 has an irregular shape, the inner frame 218 may maintain a symmetrical or uniform shape in several embodiments. The outer frame 260 can seal with the original valve.

[0120] The configurations shown in Figures 29 to 41 may be used individually or in combination with any other examples disclosed herein.

[0121] Other configurations of the artificial valve 210 may be used in multiple embodiments.

[0122] Figures 42 and 43 show an embodiment in which, for example, one or more flexible bodies 282 may extend from the proximal end 212 of the seal body 211 to the proximal portion 222 of the inner frame 218. The flexible body 282 may have a structure similar to that of one or more flexible bodies 246. For example, the flexible body 282 may be configured to seal the proximal end of the gap 248 as appropriate by sealing the fluid flow through it. The flexible body 282 may be flexible to allow movement of the seal body 211 relative to the inner frame 218 (e.g., tilting or axial movement of the seal body 211 relative to the inner frame 218). Figure 42 shows a perspective view of the artificial valve with the proximal end of the gap 248 closed, and Figure 43 shows a schematic cross-sectional view of the artificial valve. One or more flexible bodies 282 may include a cloth bridge that extends to close the proximal end portion of the gap 248.

[0123] The configurations shown in Figures 42 and 43 may be used alone or in combination with any embodiment disclosed herein.

[0124] Other configurations of the artificial valve may be used in multiple embodiments.

[0125] Figure 44 shows, for example, an embodiment in which the outer frame 284 of the seal body curves or tapers radially inward at the proximal portion 286 of the outer frame 284 in the 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 curve or taper radially outward at the distal portion 288 of the outer frame 284 in the direction from the proximal portion 286 of the outer frame 284 toward the distal portion 288 of the outer frame 284. The inner frame 218 may have a configuration similar to that discussed with respect to Figures 29 to 31, or may have a different configuration in multiple embodiments as desired.

[0126] The configuration shown in Figure 44 may be used alone or in combination with any other embodiments disclosed herein.

[0127] In several embodiments, various configurations of the prosthetic valve leaflets may be used. Such configurations of the prosthetic valve leaflets may be used to reduce stagnation of fluid (e.g., blood) flow in the neosinus space of the prosthetic valve. Figure 45 includes an exemplary diagram of a prosthetic valve 290 showing, for example, the location of the neosinus space 292 (indicated by a dashed line in Figure 45). The neosinus space 292 may be located between one outward-facing surface 294 of the prosthetic valve leaflet 296 and the inward-facing surface 298 of the valve body 300 supporting the prosthetic valve leaflet 296. The valve body 300 may be configured to obstruct fluid flow through the wall 302 of the valve body 300, for example, through the use of a seal skirt or through another configuration of a wall 302 that obstructs fluid flow through it. Thus, the neosinus space 292 may include a space or pocket in which fluid can be retained.

[0128] The neosinus space 292 may comprise a space or pocket through which fluid can stagnate when the prosthetic valve leaflets 296 open and close. Multiple prosthetic valve leaflets 296 may be arranged around a flow channel 304 through which fluid can flow. The inward-facing surface 306 of the prosthetic valve leaflet 296 may be configured to face the flow channel 304, while the outward-facing surface 294 faces the opposite side of the inward-facing surface 306 and therefore the opposite side of the flow channel 304. The neosinus space 292 may reduce fluid flow because the fluid flowing through the flow channel 304 from the inlet edge 308 of the prosthetic valve leaflet 296 towards the outlet edge 310 of the prosthetic valve leaflet 296 may be prevented from passing through the neosinus space 292 by the prosthetic valve leaflets 296. Consequently, less flow into the neosinus space 292 may result in fluid (e.g., blood) stagnation, which may lead to adverse consequences (e.g., thrombus formation, among other adverse consequences).

[0129] Repositioning of the artificial valve leaflet 296 can still generate a neosinus space 312. Figure 46 shows, for example, the repositioning of the valve leaflet 296 in the outflow direction relative to the position shown in Figure 45. The neosinus space 312 may exist between one outward-facing surface 294 of the artificial valve leaflet 296 and the inward-facing surface 298 of the valve body 300 that supports the artificial valve leaflet 296. The neosinus space 312 may be smaller in size than the space 292 shown in Figure 45, but it can generate fluid (e.g., blood) stagnation within the space 312.

[0130] Figures 47-48 illustrate examples of artificial valve leaflets 320 that may be used in several embodiments of the present disclosure in an artificial valve. A flat pattern of the artificial valve leaflet 320 is shown in Figure 47. Referring to Figure 47, the artificial valve leaflet 320 may include an outflow edge 322, a first lateral commissure end 324, and a second lateral commissure end 326 located opposite the first lateral commissure end 324. Both the first lateral commissure end 324 and the second lateral commissure end 326 may extend axially in several embodiments. The artificial valve leaflet 320 may include a central portion 328 located between the first lateral commissure end 324 and the second lateral commissure end 326.

[0131] The artificial valve leaflet 320 may include an inlet edge 330 located opposite the outlet edge 322. In some embodiments, the inlet edge 330 may include at least one indentation 332 toward the central portion 328. The indentation 332 may include a concave curvature in the inlet edge 330, or may have other configurations as desired. As shown in Figure 47, the indentation 332 may be located on the inlet edge 330 between the midline 334 of the valve leaflet 320 and the first lateral commissure end 324 of the valve leaflet 320, or on the inlet edge 330 between the midline 334 of the valve leaflet 320 and the second lateral commissure end 326 of the valve leaflet 320. The indentation 332 may be located symmetrically with respect to the midline 334, or may be located at other positions as desired. In some embodiments, a single indentation or a number of two or more indentations may be utilized in the embodiment.

[0132] Referring to Figure 47, one or more of the indentations 332 may be located at least 40% of the distance 336 along the artificial valve leaflet 320, from the outflow edge 322 toward the inflow edge 330. In some embodiments, one or more of the indentations 332 may be located at other positions (e.g., at least 30%, at least 50%, at least 60%, at least 70% of the distance 336 along the artificial valve leaflet 320, from the edge 322 toward the edge 330). At least two indentations may be located symmetrically along an axially extending midline 334, or asymmetrically in some embodiments.

[0133] One or more of the indentations 332 may be located at least 60% of the distance 338 along the prosthetic valve leaflet 320 from the midline 334 toward the first lateral commissure end 324. Another indentation 332 may similarly be located at least 60% of the distance along the prosthetic valve leaflet 320 from the midline 334 toward the second lateral commissure end 326. Other percentages (e.g., at least 40%, at least 50%, at least 70%, at least 80%) from the midline 334 toward either the first lateral commissure end 324 or the second lateral commissure end 326 may be utilized.

[0134] The inlet 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 some embodiments, the outer portion 340 may be convex with respect to the central portion 328. In some embodiments, the inner portion 342 may be convex with respect to the central portion 328. The intermediate portion 344 may include a portion of the inlet edge 330 that includes one or more recesses 332 in some embodiments. The inner portion 342 and the outer portion 340 may have a parabolic shape or other curvature that curves in the direction of inlet, and one or more recesses may, in some embodiments, have a parabolic shape or other curvature that curves toward the central portion 328.

[0135] In several embodiments, the inlet rim 330 may include a connecting line 339 that can be used to connect the valve leaflet 320 to another part of the leaflet support structure, such as the skirt 341 (shown in Figure 48) or other support material. The connecting line 339 may include a suture line in several embodiments that can be used to suture the valve leaflet 320 to the skirt 341 or other support material. The suture line may follow the contour of the inlet rim 330 and may have the shape of the inlet rim 330 in several embodiments.

[0136] In several embodiments, each lateral commissar end 324, 326 may include a connecting line for directly connecting the valve leaflet 320 to a support material (such as a skirt) or to adjacent valve leaflets 320a, b (as shown in Figure 48). Each lateral commissar end 324, 326 may include the commissar portion (shown in Figure 48) of adjacent valve leaflets 320, 320a, 320b.

[0137] Each of the lateral commissure ends 324, 326 may include an example tab that can be used to connect adjacent valve leaflets 320, 320a, 320b to one another. In some embodiments, the tab may be further configured for connection to a frame or for insertion into an opening in the frame.

[0138] In several embodiments, one or more indentations 332 may reduce the size of the neosinus space in some examples. Referring to Figure 47, one or more indentations 332 may reduce the size of the region located between the outward-facing surface 346 of the valve leaflet 320 and the inward-facing surface 348 of the valve body 350 (shown in Figure 49). Reducing the size of the neosinus space 352 (shown in Figure 49) reduces the possibility of fluid stagnation within the closed region including the neosinus space 352, and thus reduces the possibility of adverse consequences due to stagnation within the neosinus space 352 (e.g., thrombus formation or other adverse consequences). Furthermore, one or more indentations 332 may direct fluid flow toward the inner portion 342 of the valve leaflet 320, as indicated by the flow arrow 351 in Figure 47. Fluid flow toward the inner portion 342 may remove fluid from the inner portion 342 during the contraction and expansion movements of the valve leaflet 320. The fluid can be directed toward the outlet edge 322, as shown by the flow arrow 353 in Figure 47. In this way, fluid stagnation in the inner portion 342 and, in other ways, in the neosinus space 352 can be reduced.

[0139] Figure 48 shows the arrangement of three artificial valve leaflets 320, 320a, and 320b connected together. Each of the leaflets 320a and 320b may be configured similarly to leaflet 320. The lateral commissure ends of each of the artificial valve leaflets 320, 320a, and 320b may be joined together. Each of the artificial valve leaflets 320, 320a, and 320b may be connected to a skirt 341 which can be used to seal or connect the leaflets 320, 320a, and 320b to the frame or other part of the valve body. In some embodiments, three artificial valve leaflets 320, 320a, and 320b, or fewer (e.g., two), or more artificial valve leaflets may be used as desired. In some embodiments, the outflow edges 322 of the leaflets 320, 320a, and 320b may have a joint surface.

[0140] Figure 49 shows a schematic diagram of valve leaflets 320, 320a located in predetermined positions within the valve body 360. Each inlet edge 330a can be coupled to the valve body 360 such that their respective outlet edges 322, 322a extend in the outlet direction. In some embodiments, the valve body 360 may have a cylindrical shape, or may have other shapes as desired.

[0141] In several embodiments, the valve body 360 may be curved radially inward. Figure 50 shows, for example, a cross-sectional view of a portion of the valve body 362 having a radially inward curve. The valve leaflet 320 is shown in a cross-sectional view of an open configuration (i.e., a valve leaflet that is open to allow fluid flow through the flow channel). The outward-facing surface 346 of the valve leaflet 320 contours to the shape of the valve body 360 in the open configuration, closing off a portion of the neosinus space at the inner portion 342 of the artificial valve leaflet 320, and thus allowing fluid to be discharged from this portion of the neosinus space when the valve leaflet is open. In this way, a reduction in the possibility of stagnation due to the neosinus space can be achieved.

[0142] In multiple embodiments, the size of the neosinus space can be reduced by utilizing various stitch or suture patterns.

[0143] The configurations shown in Figures 47 to 50 may be used individually or in combination with any other examples disclosed herein.

[0144] Various modifications of the embodiments disclosed herein may be provided. The configurations of the embodiments may be modified, substituted, excluded, or combined across embodiments as desired. Combinations of configurations across embodiments may be made as desired. Each configuration may be provided in combination across embodiments and, if desired, in combination with other configurations excluded from that embodiment.

[0145] The various examples of seal skirts disclosed herein may take various forms, including, as desired, textile skirts, foam skirts, or braided skirts. Various materials may be used, as desired.

[0146] Various examples of artificial valve leaflets can be made from various materials as desired. Artificial valve leaflets can be made from pericardium, preferably from bovine or equine tissue. Other materials, such as polymers, can be used in particular.

[0147] The implants disclosed herein may include, among other things, a heart valve, or other forms of implants such as a stent or filter, and diagnostic devices. The implant may be an expandable implant configured to move from a compressed or undeployed state to an expanded or undeployed state. The implant may be a compressible implant configured to compress inward to have a reduced external profile and to move the implant to a compressed or undeployed state.

[0148] Various forms of delivery devices can be used in the embodiments disclosed herein. The delivery devices disclosed herein can also be used in the replacement and repair of the aorta, mitral valve, tricuspid valve, and lung. The delivery devices may include, in particular, delivery devices for delivering other forms of implants, such as stents or filters, or especially diagnostic devices.

[0149] The implants and systems disclosed herein may be used in transcatheter mitral or tricuspid valve implantation, and in transaortic valve implantation (TAVI) or replacement of other original heart valves (e.g., pulmonary valve). The delivery devices and systems disclosed herein can be used for transarterial access to the patient's heart, including transfemoral access. The delivery devices and systems can be used in transcatheter percutaneous procedures, such as transarterial procedures. Transfemoral or transcervical access can be used. Transapical procedures, in particular, can be used. Other procedures can be used as desired.

[0150] In addition, the methods disclosed herein are not limited to those specifically described herein and may include methods for using the systems and apparatus disclosed herein. Each step in the methods may be modified, excluded, or added by the systems, apparatus, and methods disclosed herein. The embodiments disclosed herein may include systems for implantation in the human body in multiple embodiments.

[0151] For the purposes of this specification, specific aspects, advantages, and novel configurations in each example of the disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any aspect. Rather, this disclosure covers all novel and non-obvious configurations and aspects in various disclosed examples, individually, in various combinations of each other, and in various partial combinations of each other. The methods, apparatus, and systems are not limited to any particular aspect or configuration or combination thereof, nor do the disclosed examples require that any one or more particular advantages exist or problems are solved. Configurations, members, or components relating to one embodiment can be combined with other embodiments in this disclosure.

[0152] Example 1: An artificial valve for deployment to an original valve, the artificial valve comprising: a plurality of artificial valve leaflets positioned around a flow channel of the artificial valve and having a plurality of commissures; a valve frame for supporting the plurality of artificial valve leaflets, which is expandable radially 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 artificial valve leaflets at a first commissure of the plurality of commissures; a second support arm extending axially and supporting at least two of the plurality of artificial valve leaflets at a second commissure of the plurality of commissures; and an opening positioned circumferentially between the first support arm and the second support arm, allowing blood flow through it; and a seal frame for sealing to the original valve.

[0153] Example 2: An artificial valve according to any embodiment of this specification, in particular Example 1, wherein the first artificial valve leaflet of the plurality of artificial valve leaflets includes a first commissure end portion located at the first commissure, a second commissure end portion located at the second commissure, and a central portion located between the first commissure end portion and the second commissure end portion, wherein the opening is aligned with the central portion of the first artificial valve leaflet in the circumferential direction.

[0154] Example 3: An artificial valve according to any embodiment of this specification, particularly Example 1 or Example 2, wherein the opening extends from a first support arm to a second support arm.

[0155] Example 4: An artificial valve according to any embodiment of this specification, particularly Examples 1 to 3, wherein the opening has a "U" shape.

[0156] Example 5: An artificial valve according to any embodiment of this specification, particularly Examples 1 to 4, wherein the first support arm extends axially in the outflow direction from the free end of the first support arm.

[0157] Example 6: An artificial valve according to any embodiment of this specification, particularly any of 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 artificial valve leaflets at a third commissure of the plurality of commissures.

[0158] Example 7: An artificial valve according to any embodiment of this specification, particularly Example 6, wherein the first support arm, the second support arm, and the third support arm are spaced equidistant from each other in the circumferential direction.

[0159] Example 8: An artificial valve according to any embodiment of the Spec, particularly the embodiments of Examples 1 to 7, further comprising a seal skirt disposed on the seal frame.

[0160] Example 9: An artificial valve according to any embodiment of this specification, particularly the embodiment described in Example 8, wherein the seal frame protrudes radially outward from the valve frame.

[0161] Example 10: An artificial valve according to any embodiment of this specification, particularly any of Examples 1 to 9, wherein the proximal portion of the artificial valve comprises an inlet portion, the distal portion of the artificial valve comprises an outlet portion, and the seal frame includes a proximal portion projecting radially outward from the proximal end of the seal frame.

[0162] Example 11: An artificial valve according to any embodiment of this specification, particularly the one described in Example 10, wherein the seal frame includes a distal portion extending distally.

[0163] Example 12: An artificial valve according to any embodiment of this specification, particularly the one described in Example 11, wherein the seal frame includes a curved portion positioned between the proximal portion and the distal portion.

[0164] Example 13: An artificial valve according to any embodiment of this specification, particularly Examples 1 to 12, wherein the seal frame surrounds the first support arm and the second support arm.

[0165] Example 14: An artificial valve according to any embodiment of the Spec, particularly Examples 1 to 13, wherein the seal frame is separated from the valve frame by a gap.

[0166] Example 15: An artificial valve according to any embodiment of this specification, particularly the one described in Example 14, wherein the gap forms at least a portion of a ring extending around the valve frame.

[0167] Example 16: An artificial valve according to any embodiment of this specification, particularly Example 14 or Example 15, further comprising one or more flow barriers positioned within the gap.

[0168] Example 17: An artificial valve according to any embodiment of this specification, particularly the artificial valves described in Examples 1 to 16, wherein the proximal portion of the artificial valve comprises an inlet portion, the distal portion of the artificial valve comprises an outlet portion, and the proximal portion of the valve frame is connected to the proximal portion of the seal frame.

[0169] Example 18: An artificial valve according to any embodiment of this specification, particularly the one described in Example 17, wherein the distal portion of the seal frame is spaced apart from the valve frame to form an opening inside the seal frame.

[0170] Example 19: An artificial valve according to any embodiment of this specification, particularly the artificial valves described in Examples 1 to 18, wherein the proximal portion of the artificial valve comprises an inlet portion, the distal portion of the artificial valve comprises an outlet portion, and the distal end of the valve frame is positioned distal to the distal end of the seal frame.

[0171] Example 20: An artificial valve according to any embodiment of this specification, particularly Examples 1 to 19, wherein the opening forms a blood flow path that is not covered by the seal frame.

[0172] Example 21: An artificial valve according to any embodiment of this specification, particularly of Examples 1 to 20, wherein the plurality of artificial valve leaflets are positioned to be held in a subannular or annular manner relative to the original valve.

[0173] Example 22: An artificial valve according to any embodiment of this specification, particularly any of Examples 1 to 21, further comprising an anchor frame modularly connected to the valve frame.

[0174] Example 23: An artificial valve according to any embodiment of this specification, particularly the one described in Example 22, wherein the anchor frame includes a lattice structure of support columns and openings.

[0175] Example 24: An artificial valve according to any embodiment of the Specified, particularly Example 22 or Example 23, wherein the anchor frame has a cylindrical shape.

[0176] Example 25: An artificial valve according to any embodiment of this specification, in particular the artificial valves according to Examples 1 to 24, further comprising one or more anchors for securing the artificial valve to the original valve.

[0177] Example 26: An artificial valve according to any embodiment of this specification, particularly Example 25, wherein the one or more anchors include a hook.

[0178] Example 27: An artificial valve according to any embodiment of this specification, particularly Example 25 or Example 26, wherein one or more anchors are shaped to extend beyond the distal tip of the original valve leaflet of the original valve.

[0179] Example 28: An artificial valve according to any embodiment of this specification, particularly Examples 25-27, wherein one or more anchors extend from one or more of the first support arm or the second support arm.

[0180] Example 29: An artificial valve according to any embodiment of this specification, in particular any one of Examples 25 to 28, wherein one or more anchors extend from the seal frame.

[0181] Example 30: An artificial valve according to any embodiment of this specification, particularly Examples 25-29, further comprising an anchor frame modularly coupled to the valve frame, wherein one or more anchors extend from the anchor frame.

[0182] Example 31: An artificial valve according to any embodiment of this specification, particularly Example 30, wherein the proximal portion of the artificial valve comprises an inflow portion, the distal portion of the artificial valve comprises an outflow portion, and the one or more anchors are positioned proximal to the blood flow path formed by the opening.

[0183] Example 32: An artificial valve according to any embodiment of this specification, particularly those of Examples 1 to 31, wherein the seal frame includes a support column and a lattice structure for the opening.

[0184] Example 33: An artificial valve according to any embodiment of this specification, particularly those described in Examples 1 to 32, wherein the seal frame is expandable radially outward from a compression configuration to an expansion configuration.

[0185] Example 34: An artificial valve according to any embodiment of this specification, particularly the artificial valves described in Examples 1 to 33, wherein the artificial valve is adapted for transcatheter delivery to the original valve.

[0186] Example 35: An example of the present specification, particularly the artificial valves described in Examples 1 to 34, wherein the artificial valve includes an artificial mitral valve or an artificial tricuspid valve.

[0187] Example 36: A method for deploying an artificial valve onto an original valve, the method comprising: a valve frame for supporting the plurality of artificial valve leaflets having a plurality of commissures and positioned around a flow channel of the artificial valve, the valve frame comprising: a first support arm extending axially and supporting at least two of the plurality of artificial valve leaflets at a first commissure of the plurality of commissures; a second support arm extending axially and supporting at least two of the plurality of artificial valve leaflets at a second commissure of the plurality of commissures; and an opening positioned circumferentially between the first support arm and the second support arm for allowing blood flow through thereto; and a seal frame for sealing with the original valve.

[0188] Example 37: A method relating to any embodiment of this specification, particularly to Example 36, wherein the first artificial valve leaflet of the plurality of artificial valve leaflets includes a first commissure end portion located at the first commissure, a second commissure end portion located at the second commissure, and a central portion located between the first commissure end portion and the second commissure end portion, wherein the opening is aligned with the central portion of the first artificial valve leaflet in the circumferential direction.

[0189] Example 38: The method according to any embodiment of this specification, particularly the method according to Example 36 or 37, wherein the opening has a "U" shape.

[0190] Example 39: The method according to any embodiment of this specification, particularly the method according to Examples 36-38, wherein the valve frame includes a third support arm that extends axially and supports at least two of the plurality of artificial valve leaflets at a third commissure of the plurality of commissures.

[0191] Example 40: The method according to any embodiment of this specification, particularly any of Examples 36 to 39, wherein the proximal portion of the artificial valve comprises an inlet portion, the distal portion of the artificial valve comprises an outlet portion, and the seal frame comprises a proximal portion projecting radially outward from the proximal end of the seal frame.

[0192] Example 41: The method according to any embodiment of this specification, particularly the method according to Examples 36-40, wherein the seal frame surrounds the first support arm and the second support arm.

[0193] Example 42: Any embodiment of this specification, particularly the methods of Examples 36-41, wherein the proximal portion of the artificial valve comprises an inlet portion, the distal portion of the artificial valve comprises an outlet portion, and the proximal portion of the valve frame is connected to the proximal portion of the seal frame.

[0194] Example 43: The method according to any embodiment of this specification, particularly the method according to any one of Examples 36 to 42, wherein the proximal portion of the artificial valve comprises an inlet portion, the distal portion of the artificial valve comprises an outlet portion, and the distal end of the valve frame is positioned distal to the distal end of the seal frame.

[0195] Example 44: Any embodiment of this specification, particularly the method of Examples 36-43, wherein the anchor frame is modularly coupled to the valve frame.

[0196] Example 45: The method according to any embodiment of this specification, particularly any one of Examples 36 to 44, wherein the original valve is a mitral heart valve or a tricuspid heart valve.

[0197] Example 46: An artificial valve for deployment to an original valve, comprising: a plurality of artificial valve leaflets; an inner frame supporting the plurality of artificial valve leaflets and including a proximal portion and a distal portion; a plurality of anchors positioned in the distal portion of the inner frame and adapted to connect with the original valve; a seal body positioned radially outward from the inner frame and having a proximal end and a distal end connected to the distal portion of the inner frame such that the seal body is adapted to move relative to the inner frame; and one or more grip configurations positioned on the seal body and adapted to engage with a portion of the original valve.

[0198] Example 47: An artificial valve according to any embodiment of this specification, in particular Example 46, wherein one or more flexible bodies connect the distal end of the seal body to the distal portion of the inner frame, allowing the seal body to move relative to the inner frame.

[0199] Example 48: An artificial valve according to any embodiment of this specification, particularly Example 47, wherein the one or more flexible bodies include a woven fabric or a shape-memory material.

[0200] Example 49: An artificial valve according to any embodiment of this specification, particularly Example 47 or Example 48, wherein one or more flexible bodies form a ring positioned at the distal end of the seal body.

[0201] Example 50: An artificial valve according to any embodiment of this specification, particularly Examples 47-49, wherein one or more flexible bodies close the distal end portion of an annular gap positioned between the seal body and the inner frame.

[0202] Example 51: An artificial valve according to any one of Examples 46 to 50, wherein the inner frame extends around a first axis, the seal body extends around a second axis, and the distal end is coupled to the distal portion of the inner frame such that the seal body is inclined with respect to the inner frame and offsets the first axis from the second axis.

[0203] Example 52: An artificial valve according to any embodiment of this specification, particularly Examples 46-51, wherein the distal end is coupled to the distal portion of the inner frame so that the seal body is adapted to move axially relative to the inner frame.

[0204] Example 53: An artificial valve according to any embodiment of this specification, particularly Examples 46-52, wherein the seal body is separated from the inner frame by an annular gap, and the proximal end of the seal body forms an opening for the annular gap.

[0205] Example 54: An artificial valve according to any embodiment of this specification, particularly any of Examples 46 to 53, wherein the seal body is separated from the inner frame by an annular gap, and a cloth bridge extends from the proximal end of the seal body to the proximal portion of the inner frame to close the proximal end portion of the annular gap.

[0206] Example 55: An artificial valve according to any embodiment of this specification, particularly Examples 46-54, wherein the inner frame includes a first frame and the seal body includes a second frame and a seal skirt.

[0207] Example 56: An artificial valve according to any embodiment of this specification, particularly Examples 46 to 55, wherein the seal body is tapered radially inward from the proximal end to the distal end.

[0208] Example 57: An artificial valve according to any embodiment of this specification, particularly any of Examples 46 to 56, wherein the proximal end portion of the seal body extends radially outward in a direction from the distal end of the seal body toward the proximal end of the seal body.

[0209] Example 58: An artificial valve according to any embodiment of this specification, particularly any of Examples 46 to 57, wherein the proximal portion of the inner frame extends radially outward in a direction from the distal portion of the inner frame toward the proximal portion of the inner frame.

[0210] Example 59: An artificial valve according to any embodiment of this specification, particularly any of Examples 46 to 58, wherein the seal body includes a frame having a plurality of supports, the distal ends of which of the plurality of supports flared radially outward.

[0211] Example 60: An artificial valve according to any embodiment of this specification, particularly Examples 46-59, wherein the plurality of anchors are adapted to press one or more original valve leaflets against the seal body.

[0212] Example 61: An artificial valve according to any embodiment of this specification, particularly Examples 46-60, wherein the plurality of anchors are fitted to hook around the distal end of the original valve leaflet of the original valve and to hold the original valve leaflet between the plurality of anchors and the seal body.

[0213] Example 62: An artificial valve according to any embodiment of this specification, in particular any one of Examples 46 to 51, wherein the one or more grip configurations are adapted to reduce the movement of one or more original valve leaflets relative to the seal body.

[0214] Example 63: An artificial valve according to any embodiment of this specification, in particular any one of Examples 46 to 62, wherein the one or more anchors are adapted to press one or more original valve leaflets toward the one or more grip configurations and to resist distal movement of the artificial valve.

[0215] Example 64: An artificial valve according to any embodiment of this specification, in particular Examples 46-63, wherein one or more grip configurations are adapted to engage with the surface of the original valve when one of the anchors fails to capture one or more original valve leaflets.

[0216] Example 65: An artificial valve according to any embodiment of this specification, in particular any one of Examples 46 to 64, wherein the one or more grip configurations include one or more barbs.

[0217] Example 66: An artificial valve according to any embodiment of this specification, in particular Example 65, wherein one or more barbs extend distally.

[0218] Example 67: An artificial valve according to any embodiment of this specification, particularly Example 65 or Example 66, wherein the seal body includes a frame having a plurality of posts, and one or more barbs are positioned on at least one of the plurality of posts.

[0219] Example 68: An artificial valve according to any embodiment of this specification, in particular Example 67, wherein the plurality of supports demarcate a plurality of openings in the frame of the seal body, and one or more barbs extend toward at least one of the plurality of openings.

[0220] Example 69: An artificial valve according to any embodiment of this specification, particularly Examples 65-68, wherein the one or more barbs are positioned such that the plurality of anchors press against the original valve leaflets relative to the one or more barbs.

[0221] Example 70: An artificial valve according to any embodiment of this specification, particularly the artificial valves described in Examples 46-69, wherein the artificial valve is for deployment to a mitral valve or a tricuspid valve.

[0222] Example 71: A method comprising the step of deploying an artificial valve onto an original valve, the artificial valve comprising: a plurality of artificial valve leaflets; an inner frame supporting the plurality of artificial valve leaflets and including a proximal portion and a distal portion; a plurality of anchors positioned on the distal portion of the inner frame and adapted to engage with the original valve; a seal body positioned radially outward from the inner frame and having a proximal end and a distal end connected to the distal portion of the inner frame such that the seal body is adapted to move relative to the inner frame; and one or more grip configurations positioned on the seal body and adapted to engage with a portion of the original valve.

[0223] Example 72: The method according to any embodiment of this specification, in particular Example 71, wherein one or more flexible bodies are coupled to the distal end of the seal body to the distal portion of the inner frame, thereby allowing the seal body to move relative to the inner frame.

[0224] Example 73: The method according to any embodiment of this specification, particularly Example 71 or Example 72, wherein the inner frame extends around a first axis, the seal body extends around a second axis, and the distal end is coupled to the distal portion of the inner frame such that the seal body is inclined with respect to the inner frame and offsets the first axis from the second axis.

[0225] Example 74: The method according to any embodiment of this specification, particularly the method according to Examples 71-73, wherein the distal end is connected to the distal portion of the inner frame so that the seal body is adapted to move axially relative to the inner frame.

[0226] Example 75: The method according to any embodiment of this specification, particularly the method according to Examples 71-74, wherein the seal body is separated from the inner frame by an annular gap, and the proximal end of the seal body forms an opening for the annular gap.

[0227] Example 76: The method according to any embodiment of this specification, particularly the method according to Examples 71-75, wherein the seal body is separated from the inner frame by an annular gap, and the proximal end of the seal body forms an opening for the annular gap.

[0228] Example 77: The method according to any embodiment of this specification, particularly the method according to Examples 71 to 76, wherein the seal body is separated from the inner frame by an annular gap, and a cloth bridge extends from the proximal end of the seal body to the proximal portion of the inner frame to close the proximal end portion of the annular gap.

[0229] Example 78: The method according to any embodiment of this specification, particularly the method according to Examples 71-77, wherein the inner frame includes a first frame and the seal body includes a second frame and a seal skirt.

[0230] Example 79: The method according to any embodiment of this specification, particularly the method according to Examples 71 to 78, wherein the seal body is tapered radially inward from the proximal end to the distal end.

[0231] Example 80: The method according to any embodiment of this specification, particularly any one of Examples 71 to 79, wherein the original valve is a mitral heart valve or a tricuspid heart valve.

[0232] Example 81: An artificial valve for deployment to an original valve, the artificial valve comprising a valve body and a plurality of artificial valve leaflets connected to the valve body, each of the plurality of artificial valve leaflets comprising an outflow edge, a first lateral commissure end, a second lateral commissure end located opposite the first lateral commissure end, a central portion located between the first lateral commissure end and the second lateral commissure end, and an inflow edge located opposite the outflow edge, wherein the inflow edge includes at least one indentation toward the central portion.

[0233] Example 82: An artificial valve according to any embodiment of this specification, in particular Example 81, wherein both the first lateral commissure end and the second lateral commissure end extend axially.

[0234] Example 83: An artificial valve according to any embodiment of the Spec, particularly Example 81 or Example 82, wherein the at least one recess is concave relative to the central portion.

[0235] Example 84: An artificial valve according to any embodiment of this specification, particularly any of Examples 81 to 83, wherein the inlet edge includes an outer portion, an inner portion, and an intermediate portion between the outer portion and the inner portion, the outer portion being convex with respect to the central portion, the intermediate portion including at least one recess, and the inner portion being convex with respect to the central portion.

[0236] Example 85: An artificial valve according to any embodiment of this specification, particularly Examples 81-84, wherein each of the plurality of artificial valve leaflets includes at least two indentations.

[0237] Example 86: An artificial valve according to any embodiment of this specification, particularly any of Examples 81 to 85, wherein each of the plurality of artificial valve leaflets is symmetrical with respect to a midline extending axially along the respective artificial valve leaflet.

[0238] Example 87: An artificial valve according to any embodiment of this specification, particularly the artificial valves according to Examples 81-86, wherein the at least one indentation is located at least 40% of the distance along each artificial valve leaflet from the outflow edge toward the inflow edge.

[0239] Example 88: An artificial valve according to any embodiment of the Spec, particularly Examples 81-87, wherein the inlet edge includes a coupling line.

[0240] Example 89: An artificial valve according to any embodiment of the Spec, particularly Examples 81-88, wherein the inlet edge includes a suture line.

[0241] Example 90: An artificial valve according to any embodiment of this specification, particularly Examples 81-89, wherein the plurality of artificial valve leaflets comprises at least three artificial valve leaflets.

[0242] Example 91: An artificial valve according to any embodiment of this specification, particularly any of Examples 81 to 90, wherein the plurality of artificial valve leaflets reduce the size of the neosinus space.

[0243] Example 92: An artificial valve according to any embodiment of this specification, particularly Examples 81 to 91, wherein the outflow edges of the plurality of artificial valve leaflets include a bonding surface.

[0244] Example 93: An artificial valve according to any embodiment of this specification, particularly Examples 81-92, wherein the first lateral commissure end and the second lateral commissure end each include a tab.

[0245] Example 94: An artificial valve according to any embodiment of this specification, particularly Examples 81-93, wherein the valve body includes a frame supporting the plurality of artificial valve leaflets.

[0246] Example 95: The artificial valve according to any embodiment of this specification, particularly the artificial valves according to Examples 81-94, wherein the artificial valve is for deployment to a mitral valve or a tricuspid valve.

[0247] Example 96: A method comprising the step of deploying an artificial valve onto an original valve, wherein the artificial valve comprises a valve body and a plurality of artificial valve leaflets connected to the valve body, each of the plurality of artificial valve leaflets comprising an outflow edge, a first lateral commissure end, a second lateral commissure end located opposite to the first lateral commissure end, a central portion located between the first lateral commissure end and the second lateral commissure end, and an inflow edge located opposite to the outflow edge, wherein the inflow edge includes at least one indentation toward the central portion.

[0248] Example 97: The method according to any embodiment of this specification, particularly the method according to Example 96, wherein both the first lateral commissure end and the second lateral commissure end extend in the axial direction.

[0249] Example 98: The method according to any embodiment of this specification, particularly Example 96 or Example 97, wherein at least one of the indentations is concave relative to the central portion.

[0250] Example 99: The method according to any embodiment of this specification, particularly any of Examples 96 to 98, wherein the inlet edge includes an outer portion, an inner portion, and an intermediate portion between the outer portion and the inner portion, the outer portion being convex with respect to the central portion, the intermediate portion including at least one recess, and the inner portion being convex with respect to the central portion.

[0251] Example 100: The method according to any embodiment of this specification, in particular any of Examples 96 to 99, wherein each of the plurality of artificial valve leaflets includes at least two indentations.

[0252] Example 101: The method according to any embodiment of this specification, particularly the method according to Examples 96-100, wherein each of the plurality of artificial valve leaflets is symmetrical with respect to a midline extending axially from each of the artificial valve leaflets.

[0253] Example 102: The method according to any embodiment of this specification, particularly the method according to Examples 96-101, wherein the at least one indentation is located at least 40% of the distance along each of the artificial valve leaflets from the outflow edge toward the inflow edge.

[0254] Example 103: The method according to any embodiment of this specification, particularly the method according to Examples 96-102, wherein the inlet edge includes a coupling line.

[0255] Example 104: The method according to any of the embodiments herein, particularly the method according to any of Examples 96 to 103, wherein the plurality of artificial valve leaflets reduce the size of the neosinus space.

[0256] Example 105: The method according to any embodiment of this specification, particularly the method according to any of Examples 96 to 104, wherein the original valve is a mitral heart valve or a tricuspid heart valve.

[0257] In summary, while aspects of this specification are emphasized by reference to specific examples, those skilled in the art will understand that these disclosed examples are merely illustrative of the principles of the subject matter disclosed herein. Therefore, it will be understood that the disclosed subject matter is not limited in any way by specific methodologies, protocols, and / or reagents, etc., as described herein. Thus, various modifications, changes, or alternative configurations relating to the disclosed subject matter can be made in accordance with the teachings herein without departing from the spirit of this specification. Finally, the terms used herein are for the purpose of describing specific examples only and are not intended to limit the scope of the systems, apparatus, and methods disclosed herein, but are defined solely by the claims. Therefore, the systems, apparatus, and methods are not limited to those strictly illustrated and described herein.

[0258] This specification describes specific examples of systems, apparatuses, and methods, including the best modes known to the inventors in carrying them out. Naturally, variations relating to these described examples will be apparent to those skilled in the art by reading the above description. The inventors anticipate that those skilled in the art will appropriately adopt such variations, and they intend that the systems, apparatuses, and methods will be carried out in ways different from those specifically described herein. Accordingly, the systems, apparatuses, and methods include all modifications and equivalents relating to the subject matter described in the appended claims, to the extent permitted by applicable law. Furthermore, unless otherwise indicated herein, and unless otherwise clearly contradicted by context, the combinations in the above examples in all possible variations in the above embodiments are encompassed by the systems, apparatuses, and methods.

[0259] Grouping of alternative examples, elements, or steps in systems, apparatus, and methods should not be construed as limiting. Components of each group may be referenced individually or in any combination with components of other groups disclosed herein, and may be claimed. It is anticipated that one or more members of a group may be included in or excluded from a group for convenience and / or patentability reasons. In the event of such inclusion or exclusion, this specification shall be deemed to contain the modified groups and thus satisfy the descriptions of all Markush groups used in the appended claims.

[0260] Unless otherwise indicated, all figures used herein to represent configurations, items, quantities, parameters, characteristics, terms, etc., should be understood in all cases to be modified by the term “approximately.” Where used herein, the term “approximately” means that the configuration, item, quantity, parameter, characteristic, or term thus modified encompasses a variable approximation, but can still perform the desired operation or process discussed herein.

[0261] The terms “a,” “an,” “the,” and similar reference terms used in the context of describing a system, apparatus, and method (particularly in the context of the claims below) shall be interpreted as encompassing both singular and plural forms unless otherwise suggested herein or unless the context clearly contradicts them. All methods described herein may be performed in any appropriate order unless otherwise shown herein and unless the context clearly contradicts them. Any use of any examples or illustrative language provided herein (e.g., “etc.”) is merely for illustrative purposes to make the system, apparatus, and method clearer, and does not imply any limitation on the scope of a system, apparatus, and method claimed otherwise. Nothing in this specification should be interpreted as indicating any non-claimed element essential to the implementation of a system, apparatus, and method.

[0262] All patents, patent publications, and other publications referenced and identified herein are incorporated herein by reference, individually and expressly, in whole, for the purpose of describing and disclosing compositions and methodologies described in such publications, which may be used, for example, in connection with systems, apparatus, and methods. Only publications disclosed prior to the filing date of this application are provided. In this regard, the inventors should not be construed as acknowledging that they do not have the right to retroactively apply to such disclosures, either by prior art or for any other reason. All statements regarding the dates or content of these documents are based on information available to the applicant and do not constitute any determination of the accuracy of the dates or content of these documents.

Claims

1. An artificial valve for deployment in the original mitral or tricuspid valve, Three artificial valve leaflets positioned around the flow channel of the artificial valve, wherein the three leaflets are attached to form three commissure regions, A valve frame for supporting the artificial valve leaflets, wherein the valve frame is radially expandable from a compression configuration to an expansion configuration, and the valve frame includes three cantilever support arms extending axially to support the three commissure regions, and three openings are provided between the three cantilever support arms to reduce thrombus formation and improve leaflet adhesion, An artificial valve comprising: an outer seal frame positioned radially outward of the valve frame, wherein the outer seal frame engages with the original mitral valve or tricuspid valve.

2. The artificial valve according to claim 1, wherein each opening is aligned with one central portion of the artificial valve leaflet in the circumferential direction.

3. The artificial valve according to claim 1 or 2, wherein the outer seal frame has a concave shape toward the ventricle in order to allow blood to flow in a funnel shape toward the valve frame and the artificial valve leaflets.

4. The artificial valve according to any one of claims 1 to 3, wherein the opening between the cantilever support arms is not substantially obstructed.

5. The artificial valve according to any one of claims 1 to 4, wherein the three cantilever support arms are radially flexible.

6. The artificial valve according to any one of claims 1 to 5, wherein each cantilever support arm further comprises an outward curved support column for resisting inward bending of one of the cantilever support arms.

7. The artificial valve according to claim 6, wherein each outer curved support is aligned with one of the commissure regions in the circumferential direction.

8. The artificial valve according to any one of claims 1 to 7, further comprising a fibrous seal skirt positioned over a substantial portion of the outer seal frame.

9. The artificial valve according to any one of claims 1 to 8, wherein the inlet portion of the valve frame is coupled to the inlet portion of the outer seal frame.

10. The artificial valve according to any one of claims 1 to 9, wherein the outlet end of the valve frame is located further downstream than the outlet end of the outer seal frame.

11. An artificial valve according to any one of claims 1 to 10, wherein the outlet end of the valve frame does not come into contact with the outlet end of the outer seal frame, and a gap is provided between the outlet end of the valve frame and the outlet end of the outer seal frame.

12. The artificial valve according to claim 11, wherein three flow barriers extend between the outer seal frame and the three cantilever support arms, thereby providing three separate regions within the outer seal frame for improved washout.

13. The artificial valve according to any one of claims 1 to 12, wherein the outer seal frame further comprises barbs along its outer surface.

14. The artificial valve according to any one of claims 1 to 13, wherein the valve frame is positioned within the original ventricle after deployment.

15. The artificial valve according to any one of claims 1 to 14, further comprising an anchor frame positioned along the inlet end of the artificial valve.

16. The artificial valve according to claim 15, wherein the anchor frame has a cylindrical shape.

17. The artificial valve according to any one of claims 1 to 16, further comprising a plurality of curved elongated anchors for capturing the original valve leaflets of the original mitral valve or tricuspid valve between the curved elongated anchors and the outer seal frame.

18. The artificial valve according to claim 17, wherein the curved, elongated anchor is configured to bend during deployment.

19. The artificial valve according to claim 17 or 18, wherein the curved, elongated anchor extends radially outward from the outer seal frame.

20. The artificial valve according to any one of claims 1 to 19, wherein the outer seal frame is formed by a support grid.

21. An artificial valve for deployment into the original valve, Multiple artificial valve leaflets, The medial frame, which supports the plurality of artificial valve leaflets and includes a proximal portion and a distal portion, A plurality of anchors positioned in the distal portion of the inner frame and adapted to capture the leaflets of the original valve, A seal body having a proximal end and a distal end connected to the distal portion of the inner frame, positioned radially outward from the inner frame and adapted to move relative to the inner frame, An artificial valve comprising one or more grip configurations positioned on the seal body and adapted to engage with a portion of the original valve.

22. The artificial valve according to claim 21, wherein one or more flexible bodies connect the distal end of the seal body to the distal portion of the inner frame, allowing the seal body to move relative to the inner frame.

23. The artificial valve according to claim 22, wherein the one or more flexible bodies include a woven fabric or a shape memory material.

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

25. The artificial valve according to any one of claims 22 to 24, wherein one or more flexible bodies close the distal end portion of an annular gap positioned between the seal body and the inner frame.

26. The artificial valve according to any one of claims 21 to 25, wherein the inner frame extends around a first axis, the seal body extends around a second axis, and the distal end is coupled to the distal portion of the inner frame such that the seal body is inclined with respect to the inner frame and offsets the first axis from the second axis.

27. The artificial valve according to any one of claims 21 to 26, wherein the seal body is separated from the inner frame by an annular gap, and the fabric bridge extends from the proximal end of the seal body to the proximal portion of the inner frame to close the proximal end portion of the annular gap.

28. The artificial valve according to any one of claims 21 to 27, wherein the one or more grip configurations include one or more barbs.

29. The artificial valve according to claim 28, wherein the one or more barbs are positioned such that the plurality of anchors press against the original valve leaflets relative to the one or more barbs.

30. The artificial valve according to any one of claims 21 to 29, wherein the artificial valve includes an artificial mitral valve or an artificial tricuspid valve.

31. An artificial valve for deployment into the original valve, The valve body and A plurality of artificial valve leaflets connected to the valve body, wherein each of the plurality of artificial valve leaflets is Outlet edge and The first lateral connecting end and A second side joint end is located on the opposite side of the first side joint end, A central portion located between the first side joint end and the second side joint end, An inlet edge located on the opposite side of the outlet edge, the inlet edge includes at least one indentation toward the central portion, An artificial valve comprising a plurality of artificial valve leaflets.

32. The artificial valve according to claim 31, wherein both the first lateral commissure end and the second lateral commissure end extend in the axial direction.

33. The artificial valve according to claim 31 or claim 32, wherein the at least one recess is concave relative to the central portion.

34. The artificial valve according to any one of claims 31 to 33, wherein the inlet edge includes an outer portion, an inner portion, and an intermediate portion between the outer portion and the inner portion, the outer portion being convex with respect to the central portion, the intermediate portion including at least one recess, and the inner portion being convex with respect to the central portion.

35. The artificial valve according to any one of claims 31 to 34, wherein the at least one recess is located at least 40% of the distance along each of the artificial valve leaflets from the outflow edge toward the inflow edge.

36. The artificial valve according to any one of claims 31 to 35, wherein the inlet edge portion is provided with a connecting wire.

37. The artificial valve according to any one of claims 31 to 36, wherein the plurality of artificial valve leaflets reduce the size of the neosinus space.

38. The artificial valve according to any one of claims 31 to 37, wherein the outflow edges of the plurality of artificial valve leaflets include a joint surface.

39. The artificial valve according to any one of claims 31 to 38, wherein the valve body includes a frame that supports the plurality of artificial valve leaflets.

40. The artificial valve according to any one of claims 31 to 39, wherein the artificial valve includes an artificial mitral valve or an artificial tricuspid valve.

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