Heart valve prosthesis and related methods

Abstract

A prosthetic valve for treating blood regurgitation through a native heart valve can include a body including an inlet portion and an outlet portion having a first leaflet and a second leaflet, and the body defining a flow passage having an inlet within the inlet portion, a first outlet within the first leaflet, and a second outlet within the second leaflet; and a flow control device disposed in the flow passage within the inlet portion and a clip connector coupled to the body. The prosthetic valve is configured to be disposed in a native valve of a heart that has been pinched to create a first flow control portion and a second flow control portion, with the inlet disposed in a heart atrium and the first outlet and the second outlet disposed in a heart ventricle, wherein the leaflets are configured to be disposed in the flow control portions in substantially sealing relation with the first leaflet and the second leaflet. The prosthetic valve is further configured to allow blood to flow from the atrium to the ventricle through the flow passage and substantially prevent blood from flowing from the ventricle to the atrium through the flow passage or between the body and the leaflets during a contraction of the heart. The clip connector is configured to selectively couple to a clip and resist displacement of the body toward the atrium during the contraction.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 046,841, filed July 1, 2020, entitled “Mitral Valve Protheses and Related Methods,” the disclosure of which is incorporated herein by reference in its entirety.

[0003] This application also relates to U.S. Patent No. 10,912,646, entitled “Methods, Apparatus and Devices to Treat Heart Valves” (“Patent No. 646”), the disclosure of which is incorporated herein by reference in its entirety. Background Technology

[0004] The diverse forms of valvular insufficiency affecting various heart valves (such as the aortic, tricuspid, pulmonary, and mitral valves) have led to a continuously expanding field of research and development aimed at improving valvular function. While any one or more of these natural heart valves can be impaired due to conditions such as congenital diseases or more common medical conditions, the mitral valve has received particular attention. Backflow of blood through a heart valve (such as the mitral valve) involves blood flowing backward across the valve when it should be fully closed (i.e., complete closure of the natural leaflets). When the mitral valve is diseased or damaged, blood that would normally be allowed to flow back from the left ventricle into the left atrium during cardiac systole is instead allowed to flow. This results in a reduced amount of blood ejected from the left ventricle during cardiac systole, leading to a lower-than-optimal ejection fraction in patients. Consequently, patients may experience a lower quality of life due to cardiac inefficiency or, worse, life-threatening conditions.

[0005] Surgical techniques, including transvascular and catheter-based methods, have been developed for the treatment of mitral valve insufficiency, including, for example, mitral annulusoplasty, which attaches the natural anterior leaflet of the mitral valve to the natural posterior leaflet, notochord replacement, and even complete mitral valve replacement. Similar approaches have been developed for the treatment of tricuspid valve insufficiency.

[0006] In many cases, mitral regurgitation is not related to congenital defects in the mitral valve leaflets, but rather to changes in the leaflet engagement over time due to heart disease. In these cases, the natural mitral valve leaflets are often relatively normal, but during systole, they still fail to prevent blood from flowing back from the left ventricle to the left atrium. Instead of the natural anterior and posterior leaflets properly matching or fully engaging during cardiac contraction or systole, one or more gaps between the natural leaflets can lead to mitral regurgitation. The tricuspid valve also encounters similar problems.

[0007] The current commonly used technique for reducing mitral regurgitation is an edge-to-edge approximation or repair procedure that includes using a clip structure to attach the native mitral valve anterior leaflet to the native mitral valve posterior leaflet. The use of edge-to-edge mitral valve repair procedures to treat mitral regurgitation flow is rapidly increasing. Abbott has introduced the MitraClip TM device to the market, and Edwards recently introduced the PASCAL device. The MitraClip TM fastens or clips the mitral valve anterior leaflet to the mitral valve posterior leaflet, while PASCAL achieves the same function by adding material between the native leaflets, offering some advantages to the procedure.

[0008] The MitraClip TM repair procedure currently uses about two clips per procedure, and many patients treated still have mitral regurgitation. There is a gap between the native mitral valve anterior and posterior leaflets during systole, which leads to persistent mitral regurgitation even after they are clipped together. Clinical studies have shown that using a clip can improve patient outcomes, but many patients still have severe conditions and require continuous strict medical supervision. Abbott has also developed the TriClip TM device for clipping the native leaflets of the tricuspid valve.

[0009] The ‘646 patent discloses devices that attach to edge-to-edge mitral valve clipping devices to prevent any residual leakage. These devices and methods seal the gap between the native mitral valve leaflets during systole and allow filling of the left ventricle during diastole. Some devices are fixed in shape, and others have moving parts or leaflets that close the residual gap during systole and allow blood to enter the left ventricle during diastole.

[0010] One particularly promising variation disclosed in the ‘646 patent is a bileaflet valve that can be positioned and attached to an edge-to-edge clip. Many variations in this solution have been shown, including (but not limited to) Figures 5-11, 15-29, and 35 of the ‘646 patent, also included herein.

[0011] Each of these variations requires the development of a new type of valve - typically a bileaflet valve - that fills the gap between the native leaflets during systole and moves to allow blood to enter the left ventricle (LV) during diastole. This valve requires a significant amount of testing and development before it can be used clinically. There is no similar bileaflet device on the market. Therefore, this new device can fail, with development and regulatory risks. There is also a chance that the bileaflet device will not be widely accepted by physicians who have been using trileaflet valves for over 50 years.

[0012] Three leaflet stent-valves have proven to be effective and safe. For over 50 years, it has been the mainstay of surgical tissue valves, with millions of valves having a three-leaflet structure implanted in patients and having good long-term results. In the past decade, hundreds of thousands of stent-valves with three leaflets have been successfully used in patients receiving catheter-based heart valve replacement surgery. Given the usefulness of using two proven technologies (marginal-to-marginal devices and three-leaflet stent-valves) for treating mitral regurgitation. These combinations will reduce time to market as well as regulatory and adoption risk, in addition to clinical advantages.

[0013] Now, many physicians are very skilled in performing mitral clipping (using a clip such as the MitraClip TM together) and tricuspid clipping (using a clip such as the MitraClip TM together). They are also confident in their reliability and ability to deliver stent-valves. Building a device that leverages these proven implants and skill sets will be welcomed by physicians and safer for patients who have them perform a familiar procedure.

[0014] It would be useful to further address these and other issues or challenges associated with heart valve insufficiency. SUMMARY

[0015] In some embodiments, the artificial valve includes: a body including an inlet and an outlet having a first leaflet and a second leaflet; and defining a flow channel having an inlet in the inlet, a first outlet in the first leaflet, and a second outlet in the second leaflet; and a flow control device disposed within the inlet in the flow channel and configured to allow fluid to flow through the flow channel in a first direction from the inlet to the first and second outlets, and to prevent fluid from flowing through the flow channel in a second direction opposite to the first direction. The artificial valve is configured to be disposed in a natural valve of the heart, wherein a first leaflet is coupled to a second leaflet by a clip, a first flow control portion is defined between the first leaflet, the second leaflet, and the clip, and a second flow control portion is defined between the first and second leaflets and the clip, wherein the inlet is disposed in the atrium of the heart, and the first and second outlets are disposed in the ventricles of the heart. The first flap is configured to be disposed in the first flow control section in a substantially sealing relationship with the first and second leaflets, and the second flap is configured to be disposed in the second flow control section in a substantially sealing relationship with the first and second leaflets. The artificial valve is also configured to allow blood to flow from the atrium to the ventricle during diastole through the inlet, flow control device, fluid passage, and first and second outlets, and to substantially prevent blood from flowing from the ventricle to the atrium through the flow passage or between the body and leaflets during systole. The clip connector is configured to selectively couple to the clip and to resist displacement of the body toward the atrium during systole.

[0016] In other embodiments, the artificial valve has a body including an inlet and an outlet, defining a flow channel having the inlet and outlet in the inlet, a flow control device disposed within the inlet in the flow channel and configured to allow fluid to flow through the flow channel in a first direction from the inlet to the outlet and to inhibit fluid from flowing through the flow channel in a second direction opposite to the first direction, and a clip connector coupled to the body. The artificial valve is configured to be disposed in a natural valve of the heart, wherein a first leaflet is coupled to a second leaflet by a clip, a flow control portion is defined between the first leaflet, the second leaflet, and the clip, the inlet is disposed in the atrium of the heart, and a first outlet is disposed in the ventricle of the heart. The outlet is configured to be disposed in the flow control portion in a substantially sealing relationship with the first and second leaflets. The artificial valve is configured to allow blood to flow from the atrium to the ventricle through the inlet, the flow control device, the flow channel, and the outlet during diastole, and substantially prevents blood from flowing from the ventricle to the atrium through the flow channel or between the body and the leaflets during systole. The clip connector is configured to selectively couple to the clip and resist displacement of the body toward the atrium during contraction.

[0017] Additional features, aspects and / or advantages will be recognized and understood upon further review of the detailed description of the example implementations taken in connection with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0018] FIG. 1A is a schematic illustration of a system constructed in accordance with one example implementation.

[0019] FIG. 1B is a schematic perspective view of a native left atrium and mitral valve similar to FIG. 1A but showing installation of a catheter-delivered selective occlusion device.

[0020] FIG. 1C is a schematic perspective view similar to FIG. 1B but showing the membrane of the selective occlusion device in place on the frame structure.

[0021] FIG. 2A is a cross-sectional view taken along line 2A-2A of FIG. 3A across the selective occlusion device when the cardiac cycle is in the systolic phase.

[0022] FIG. 2B is a cross-sectional view similar to FIG. 3A taken along line 2B-2B of FIG. 2A during the systolic phase of the cardiac cycle.

[0023] FIG. 2C is a cross-sectional view similar to FIG. 2B but showing the native mitral valve and selective occlusion device during the diastolic phase of the cardiac cycle.

[0024] FIG. 3A is a top view of the native mitral valve and selective occlusion device when the heart is in the systolic phase.

[0025] FIG. 3B is a top view similar to FIG. 3A but showing the device and native mitral valve when the heart is in the diastolic phase.

[0026] FIG. 4A is a perspective view of the device as shown in the previous figures, with the membrane of the device removed for clarity and only the frame structure shown in solid lines.

[0027] FIG. 4B is a perspective view similar to FIG. 4A but showing the membrane applied to the frame structure of the device.

[0028] FIG. 5A is a schematic perspective view similar to FIG. 1Ais a partial cross-sectional view, but shows a catheter or catheter-based delivery and implantation system configured according to another embodiment.

[0029] FIG. 5B is a view similar to FIG. 5A but shows a subsequent step in the method, where the native mitral valve leaflets have been captured and clamped together.

[0030] FIG. 5C is a view similar to FIG. 5A and 5B but shows the frame of the selective occlusion device implanted and attached to the clip structure, and the flexible membrane is removed for clarity.

[0031] FIG. 5D is a view similar to FIG. 5C but shows the flexible membrane of the device in place on the frame structure.

[0032] FIG. 6A is a perspective view of the frame structure and attached clip structure shown in FIG. 5A to 5C

[0033] FIG. 6B is a perspective view similar to FIG. 6A but shows another embodiment of the collapsible and expandable frame structure.

[0034] FIG. 7A is a cross-sectional view of the native mitral valve and selective occlusion device of FIG. 6B , and the heart is in diastolic phase.

[0035] FIG. 7B is a cross-sectional view similar to FIG. 7A but shows the selective occlusion device and mitral valve when the heart is in systolic phase.

[0036] FIG. 8 is a side view and a cross-section of the heart at the location of the native mitral valve, showing the selective occlusion device of FIG. 7A and FIG. 7B , the membrane is shown in dashed lines for clarity, and the device is implanted.

[0037] FIG. 9 is a perspective view showing another embodiment of the selective occlusion device, the frame structure is shown in solid lines for clarity, and the flexible membrane is shown in dashed lines.

[0038] FIG. 10A is a perspective view similar to FIG. 1A and 5A ​is a schematic perspective view, but shows another embodiment of a catheter-based system for delivering and implanting a selective occlusion device coupled with a pre-mounted mitral valve leaflet clip structure.

[0039] FIG. 10B is a view similar to FIG. 10A but shows a subsequent step during the method.

[0040] FIG. 10C is a perspective view, and the heart is cut open at the native mitral valve, showing implantation of the selective occlusion device, but the flexible membrane is removed for clarity.

[0041] FIG. 11A is a perspective view showing another alternative embodiment of the selective occlusion device with the flexible membrane removed for clarity.

[0042] FIG. 11B is a perspective view showing another alternative embodiment of the selective occlusion device with the flexible membrane removed for clarity.

[0043] FIG. 11C is a front perspective view of the device of FIG. 11A or 1 IB implanted in the native mitral valve.

[0044] FIG. 11D is a front view of the device in FIG. 11A to 11C .

[0045] FIG. 11E is a lateral cross-section of FIG. 11D .

[0046] FIG. 12A is a perspective view of another alternative embodiment of the selective occlusion device implanted in the native mitral valve, shown in cross-section similar to the previous figures.

[0047] FIG. 12B is a cut-away view of the heart taken at the native mitral valve, and shows the selective occlusion device of FIG. 12A in a side view.

[0048] FIG. 12C is a view similar to FIG. 12B but shows another alternative embodiment of the selective occlusion device implanted in the native mitral valve.

[0049] FIG. 12D is another view similar to FIG. 12C but shows another alternative embodiment of the selective occlusion device implanted in the native mitral valve.

[0050] FIG. 13A is a cross-section through the mitral valve and generally through FIG. 12A to FIG. 12DA cross-sectional view of one of the selective occlusion elements is shown to illustrate the seal during contraction.

[0051] FIG. 13B It is similar to FIG. 13A The view shows the selective occlusion element and mitral valve when the heart is in the diastolic phase.

[0052] FIG. 13C It is similar to FIG. 13B The view shows an alternative embodiment of the selective occlusion element.

[0053] FIG. 14A This is a perspective view of another alternative embodiment of the selective occlusion device and mitral valve clip structure.

[0054] FIG. 14B This is a perspective view of another alternative embodiment of the selective occlusion device and mitral valve clip structure.

[0055] FIG. 14C This is a perspective view of another alternative embodiment of the selective occlusion device and mitral valve clip structure.

[0056] FIG. 15A This is a perspective view of another alternative embodiment of the selective occlusion device, in which the flexible membrane is disconnected for clarity.

[0057] FIG. 15B It is similar to FIG. 15A The image shows a three-dimensional view, but further reveals the flexible membrane on the frame structure.

[0058] FIG. 15C yes FIG. 15A and 15B The side view of the selective occlusion device shown has the flexible membrane removed for clarity.

[0059] FIG. 15D It is similar to FIG. 15C The side view shows a flexible membrane applied to the frame structure.

[0060] FIG. 15E yes FIG. 15A to 15D The diagram shows a top view of the device, but a cross-section of the membrane is shown to illustrate the shape of the membrane when it is in an expanded or inflated state during the systolic phase of the heart.

[0061] FIG. 16A It is a three-dimensional diagram of the system and the heart, similar to FIG. 5A However, an alternative implementation of a catheter-based system and method is shown for implanting a selective occlusion device and clip structure into a natural mitral valve.

[0062] FIG. 16B It is similar toFIG. 16A The diagram is a 3D representation, but it shows the subsequent steps in the method.

[0063] FIG. 16C It is similar to FIG. 16B The view shows one subsequent step in the method, but it does not.

[0064] FIG. 16D This is a three-dimensional view showing a selective occlusion device implanted in a patient's mitral valve.

[0065] FIG. 17A It is a natural mitral valve and FIG. 16A to FIG. 16D A selective occlusion device was implanted and fixed to the mitral valve clip structure. (Side sectional view)

[0066] FIG. 17B It is similar to FIG. 17A The side sectional view shows the subsequent steps in the method.

[0067] FIG. 17C It is similar to FIG. 17B The side sectional view shows a subsequent step in the method in which the device is fully implanted.

[0068] FIG. 18A Is it like this? FIG. 16A to 16D The selective occlusion device shown in 17A to 17C is a cross-sectional view, and the device and mitral valve are shown when the heart is in the diastolic phase.

[0069] FIG. 18B It is similar to FIG. 18A The view shows the device and the natural mitral valve when the heart is in the systolic phase.

[0070] FIG. 19 It is a top view, which schematically illustrates the shape of the selective occlusion device when implanted into a natural mitral valve with anatomical curvature.

[0071] FIG. 20 This is a perspective view of a selective blocking device constructed according to another alternative embodiment.

[0072] FIG. 21A It is along FIG. 20 The shown device is a side sectional view taken roughly along its length from the central portion.

[0073] FIG. 21B yes FIG. 21A Top view of the device shown.

[0074] FIG. 21C yes FIG. 21B A cross-sectional view of the device shown.

[0075] FIG. 22A is a perspective view of a catheter-based system and method according to another alternative implementation being performed on a native mitral valve, shown in a schematic cross-sectional portion of a heart.

[0076] FIG. 22B is a view similar to FIG. 22A but showing a subsequent step in the method.

[0077] FIG. 22C is a view similar to FIG. 22B but showing another subsequent step in the method.

[0078] FIG. 22D is a perspective view showing a fully implanted device in a native mitral valve, resulting from the method shown by FIG. 22A to 22C .

[0079] FIG. 22E is a view similar to FIG. 22D but showing an alternative frame structure attached to the selective occlusion device.

[0080] FIG. 22F is a view similar to FIG. 22E but showing another alternative frame structure.

[0081] FIG. 22G is a view similar to FIG. 22F but showing another alternative frame structure.

[0082] FIG. 23A is a cross-sectional view of another embodiment of a native mitral valve and heart valve repair device, showing the heart in a systolic phase.

[0083] FIG. 23B is a view similar to FIG. 23A but showing the device and mitral valve when the heart is in a diastolic phase.

[0084] FIG. 24 is a side cross-sectional view of another alternative embodiment of a heart valve repair device implanted in a native mitral valve.

[0085] FIG. 25A is a cross-sectional view of another alternative embodiment of a heart valve repair device.

[0086] FIG. 25B is a cross-sectional view of another alternative embodiment of a heart valve repair device implanted in a native mitral valve.

[0087] FIG. 26A is another alternative embodiment of a selective occlusion device shown in cross-section.

[0088] FIG. 26B is a schematic view showing FIG. 26A implantation of the device into a native mitral valve.

[0089] FIG. 26C is a perspective view showing FIG. 26A and 26B implantation of the device into a native mitral valve.

[0090] FIG. 26D is a cross-sectional view of another alternative heart valve repair device implanted into a native mitral valve.

[0091] FIG. 26E is a cross-sectional view of another alternative heart valve repair device implanted into a native mitral valve.

[0092] FIG. 27A is a perspective view of another alternative selective occlusion device.

[0093] FIG. 27B is a longitudinal cross-sectional view of the device shown in FIG. 27A , schematically showing blood flow during a systolic phase of the heart.

[0094] FIG. 27C is a cross-sectional view of the device shown in FIG. 27A and 27B , showing during systole of the heart.

[0095] FIG. 28A is a perspective view showing another alternative embodiment of another device comprising a selective occlusion device and a mitral valve clip structure.

[0096] FIG. 28B is a longitudinal cross-sectional view of the device shown in FIG. 28A and the clip structure.

[0097] FIG. 28C is a cross-sectional view of the device shown in FIG. 28A and 28B .

[0098] FIG. 29A is a cross-sectional view of a selective occlusion device and a clip structure, schematically showing blood flow between the endocardial wall surfaces during a systolic phase of the heart.

[0099] FIG. 29B is a cross-sectional view of the device shown in FIG. 29A implanted into a native mitral valve, and showing the device and the mitral valve when the heart is in a systolic phase.

[0100] FIG. 30 is a perspective view showing a cross-section of a mitral valve and a fully implanted selective occlusion device and clip structure.

[0101] FIG. 31 is a perspective view showing another alternative embodiment of a prosthetic heart valve and leaflet clip structure.

[0102] FIG. 32A is a side view partially sectioned to show a prosthetic heart valve and leaflet clip structure.

[0103] FIG. 32B is a cross-sectional side view of a native heart valve showing the initial portion of an implantation procedure associated with a prosthetic heart valve of the type shown in FIG. 31 and 32A .

[0104] FIG. 32C is a view similar to FIG. 32B but showing a subsequent step in the method.

[0105] FIG. 32D is a view similar to FIG. 32C but showing a subsequent step in the method.

[0106] FIG. 32E is a view similar to FIG. 32D but showing the fully implanted prosthetic heart valve clamped to the native heart valve leaflets and expanded into an implanted state.

[0107] FIG. 33 is a perspective view of another alternative embodiment of a prosthetic heart valve and native leaflet clip structure.

[0108] FIG. 34A is a side view of the prosthetic heart valve shown in FIG. 33 .

[0109] FIG. 34B is a view of the prosthetic heart valve of FIG. 34A implanted into a native heart valve.

[0110] FIG. 35A is a sectional view similar to FIG. 29B but showing another exemplary embodiment of a heart valve repair device implanted into a mitral valve and showing a systolic phase of a cardiac cycle.

[0111] FIG. 35B is a sectional view similar to FIG. 35A but showing the device and mitral valve when the cardiac cycle is in a diastolic phase.

[0112] FIG. 36A and 36B are illustrations of the anatomical structure of a native mitral valve and a native tricuspid valve, respectively.

[0113] FIG. 37A is a schematic illustration of a native mitral valve.

[0114] FIG. 37B to 37D is a schematic illustration of a native mitral valve after clipping, with one or more clips engaged with the native leaflets.

[0115] FIG. 38A to 38F is a schematic illustration of a native tricuspid valve after clipping, with one or more clips engaged with the native leaflets.

[0116] FIG. 39A and 39B are schematic illustrations of side and top views, respectively, of a prosthetic valve according to an embodiment.

[0117] FIG. 40A and FIG. 40B are FIG. 39A and FIG. 39B schematic illustrations of a prosthetic valve according to an embodiment, shown disposed in a native mitral valve, in side and top views, respectively.

[0118] FIG. 41 are flowcharts of a method of delivering a prosthetic valve according to an embodiment. FIG. 39A 39B

[0119] FIG. 42A 42B are perspective partial views, partial cross-sectional side views of a prosthetic valve according to an embodiment.

[0120] FIG. 42C are perspective views of a prosthetic valve according to an embodiment, shown disposed in a native mitral valve. FIG. 42A 42B is a partial end cross-sectional view showing a variation of a clip connector of a prosthetic valve according to an embodiment.

[0121] FIG. 42D to 42F FIG. 42A to 42C

[0122] FIG. 43 is a partial cross-sectional side view of a prosthetic valve according to an embodiment.

[0123] FIG. 44 is a partial cross-sectional side view of a prosthetic valve according to an embodiment.

[0124] FIG. 45A to 45C is a partial cross-sectional side view of a prosthetic valve according to an embodiment, showing a process for expanding a prosthetic valve leaflet.

[0125] FIG. 46A to 46C are top, side, and partial cross-sectional side views, respectively, of a prosthetic valve according to an embodiment.

[0126] ​​​​​​FIG. 47A to 47D is a top view, side view, end view, and exploded end view of a prosthetic valve disposed in a native mitral valve according to an embodiment.

[0127] FIG. 48 is a top view of a prosthetic valve according to an embodiment. FIG. 47A to 47D

[0128] FIG. 49A and 49B are a top view and a side view, respectively, of a prosthetic valve according to an embodiment.

[0129] FIG. 50 is a side view of a prosthetic valve according to an embodiment.

[0130] FIG. 51A and 51B are a top view and a partial cross-sectional end view, respectively, of a prosthetic valve according to an embodiment.

[0131] FIG. 51C to 51F are perspective views of components of a flow control device of a prosthetic valve. FIG. 51A 51B

[0132] FIG. 52A and 52B are a side view and a top view, respectively, of a prosthetic valve according to an embodiment.

[0133] FIG. 53A and FIG. 53B are FIG. 52A and FIG. 52B are schematic views of a prosthetic valve according to an embodiment, shown in a side view and a top view, respectively, disposed in a native mitral valve.

[0134] FIG. 54 are flow diagrams of a method of delivery of a prosthetic valve according to an embodiment. FIG. 52A 52B

[0135] FIG. 55A to 55C are a side perspective view, a top view, and a top perspective view of a prosthetic valve disposed in a centrally clamped mitral valve according to an embodiment.

[0136] FIG. 56A and 56B are a top view of a prosthetic valve disposed in a centrally clamped mitral valve according to an embodiment, and FIG. 56C to 56I illustrates mechanisms and procedures for securing a prosthetic valve into a mitral valve using a clip.

[0137] FIG. 57A and 57B ​​​​​are top and end views of a prosthetic valve according to one embodiment, shown disposed in an eccentrically clamped mitral valve.

[0138] FIG. 58A and 58B are top and end views of a prosthetic valve according to one embodiment, shown disposed in an eccentrically clamped mitral valve.

[0139] FIG. 59A and 59B are top and end views of a prosthetic valve according to one embodiment, shown disposed in an eccentrically clamped mitral valve.

[0140] FIG. 60A and 60B are perspective top and side views of a prosthetic valve according to one embodiment, shown disposed in an eccentrically clamped mitral valve.

[0141] FIG. 60C and 60D is FIG. 60A and 60B perspective top view of a prosthetic valve showing an alternative heart tissue tether.

[0142] FIG. 61A is a top view of a prosthetic valve according to one embodiment, shown disposed in an eccentrically clamped mitral valve, and FIG. 61B is FIG. 61A a top perspective view of a clip of

[0143] FIG. 62 is a top view of a prosthetic valve according to one embodiment, shown disposed in a mitral valve clamped with two eccentrically placed clips.

[0144] FIG. 63 is a top view of a prosthetic valve according to one embodiment, shown disposed in a tricuspid valve clamped with two clips during a three-hole clamping procedure.

[0145] FIG. 64A and 64B are top and top perspective views of a prosthetic valve according to one embodiment, shown disposed in a tricuspid valve clamped with three clips, as FIG. 64A indicated.

[0146] FIG. 65A is a cross-sectional perspective view of a delivery system for FIG. 64A and 64B clips and prosthetic valves, FIG. 65B to 65D showing delivery of the clips to a tricuspid valve, resulting in a clamped tricuspid valve, as FIG. 64A indicated.

[0147] FIG. 66 is a top view of a prosthetic valve according to one embodiment, showing the tricuspid valve set up in a mitral valvuloplasty with three clips clamped.

[0148] FIG. 67A to 67C shows heart tissue tethering for the clips and the process for delivering and deploying the tether and clips. DETAILED DESCRIPTION

[0149] The detailed description herein is directed to describing non-limiting implementations or embodiments that relate to various inventive concepts and uses the reference numerals in the drawings to facilitate understanding of these embodiments. As will be appreciated, common reference numerals in the drawings refer to common features and structures throughout the several drawings. While the various drawings will have common reference numerals referring to common features and structures, the subsequent drawing description will not necessarily repeat discussion of these features and structures for the sake of brevity.

[0150] Referring first to FIG. 1A , a native heart 10 is shown and includes a left atrium 12, a left ventricle 14, and a native mitral valve 16 that controls blood flow from the left atrium 12 to the left ventricle 14. A tricuspid valve 18 is also shown in communication with a right ventricle 19. The mitral valve 16 includes an anterior leaflet 16a, a posterior leaflet 16b, and a native valve annulus 16c. When the mitral valve 16 is functioning properly, it will open to allow blood to flow from the left atrium 12 into the left ventricle 14 during the diastolic portion of the cardiac cycle. When the heart 10 contracts during the systolic phase, the anterior and posterior native mitral valve leaflets 16a, 16b will fully coapt or join with one another to prevent any retrograde flow of blood into the left atrium 12, and the blood in the left ventricle 14 will be effectively ejected and pass completely through the aortic valve (not shown). A catheter 20 carries a collapsed, selectively occlusive device 22 along a guide wire 24. In this exemplary procedure, the catheter 20 is delivered through a transseptal puncture 12a. It will be appreciated that any other transcatheter method or other surgical method with varying degrees of invasiveness can alternatively be used. The patient can or can not be bypassed during the procedure, and the heart can or can not be beating. As will be appreciated, the selectively occlusive device 22 can be delivered through a transseptal puncture or other transcatheter method, or it can be delivered surgically with or without a beating heart. FIG. 1A Further shown, the native mitral valve leaflets 16a, 16b are supported by chordae 26 that are attached to papillary muscles 28. As will be appreciated, the chordae 26 can be cut or otherwise severed during the procedure. FIG. 1A As shown schematically in

[0151] Now referring to FIG. 1B and 1C FIG. 1A ​and the selective occlusion device 22 has been fully extruded or extended from the distal end 20a of the catheter 20 and transitioned from a collapsed position or state within the catheter 20 as shown in FIG. 1A to a deployed state as shown in FIG. 1B and 1C As further shown in FIG. 1B and 1C the selective occlusion device 22 includes a collapsible and deployable frame structure 30. The frame structure 30 includes a curved frame member 32 that extends generally across the native mitral valve 16 while being supported or stabilized at the native valve annulus 16c. The selective occlusion device 22 is collapsible to allow it to be delivered as shown in FIG. 1A but is deployed to FIG. 1B and 1Cembodiments and / or other embodiments. The frame members 32 can instead extend from other portions of the heart tissue located generally at the annulus region. At opposite ends, the frame structure 30 is supported by respective first and second non-penetrating annulus connectors 34, 36. As examples of non-penetrating annulus connectors, these connectors are configured with respective upper connector elements 34a, 34b and lower connector elements 36a, 36b. These connector elements 34a, 34b and 36a, 36b respectively clamp or capture the annular tissue therebetween at each commissure. The connector elements 34a, 34b and 36a, 36b are respectively shown as "butterfly-type" connectors that can be slid or inserted into place with the native leaflet tissue clamped therebetween or secured therebetween. It will be understood that other tissue capturing connectors can instead be used, and / or other penetrating or non-penetrating connectors. Non-penetrating connectors are advantageous in that they do not cause damage due to penetrating connectors, and they allow for positional adjustment. The frame structure 30 further includes first and second membrane support members 38, 40 at opposite ends that are configured to be located in the left ventricle 14 to support a flexible membrane 44 in a slightly open state. The flexible membrane 44 together with the frame structure 30 forms a selective occlusion device that cooperates with the native mitral valve leaflets 16a, 16b to control blood flow through the mitral valve 16. As described below, the flexible membrane 44 used as a prosthetic heart valve in this embodiment is moved by cooperating movement with the leaflets 16a, 16b. In other embodiments, the selective occlusion device need not have any moving parts that move with the leaflets 16a, 16b. The flexible membrane 44 is secured to the support members 38, 40 at opposite portions of the frame structure 30 in any suitable manner, such as adhesive, mechanical fixation, suturing, fasteners, etc. As further shown, a substantial portion at the lower edge of the flexible membrane 44 is not attached to the frame structure 30. The membrane support members 38, 40 are short and curved members, and the remaining membrane portion at the lower edge of the flexible membrane 44 is not directly attached to any frame portion.As discussed further below, this allows the flexible membrane to bulge, unfold or expand outward to engage with the native leaflets 16a, 16b during systole and prevent blood flow regurgitation through the mitral valve 16 in the opposite direction when the cardiac cycle is in systole.

[0152] The flexible membrane 44 can be formed from various types of thin, flexible materials. For example, the material can be natural, synthetic or bioengineered. The material can include valve tissue or pericardial tissue from animals such as cows and pigs or other sources. Synthetic materials or combinations of materials such as ePTFE, Dacron, Teflon or other materials can be used to construct the flexible membrane 44. The flexibility of the frame structure 30 together with the flexibility of the flexible membrane 44 together provide for the operation of the selective occlusion device 22 in the manner contemplated herein and can also help prevent failure due to fatigue caused by the repetitive cyclical motion of the selective occlusion device 22 in the heart 10. It will be appreciated that, FIG. 1B The flexible membrane 44 is shown removed to clearly see the frame structure 30 and in this figure the flexible membrane 44 is shown in dashed lines while in FIG. 1C the flexible membrane 44 is shown in solid lines where the cardiac cycle is in systole and the flexible membrane 44 fully engages the native leaflets 16a, 16b to reduce blood flow regurgitation through the mitral valve 16. The flexible membrane 44 can be stitched to the frame structure 30 using techniques employed by the artificial heart valve industry for manufacturing artificial aortic valves and mitral valves. The frame can be made of one or more layers of material, such as super-elastic or shape memory material, and the membrane 44 can be suitably secured. One way can be to capture the flexible membrane 44 between the layers of the frame structure 30. To hold the membrane 44 in place, a fabric covering (not shown) attached to the metal frame can help attach the membrane 44 to the frame structure 30.

[0153] FIG. 2A 、 2B and 2C are cross sections through the selective occlusion device 22 and the mitral valve 16 as shown in FIG. 1A to 1C FIG. 2A The selective occlusion device 22 is shown in cross section along line 2A-2A of FIG. 3A FIG. 2B The selective occlusion device 22 is shown in cross section along line 2B-2B of FIG. 3A both figures showing the cardiac cycle in systole. FIG. 3A and 3B are top views showing systole and diastole respectively, but do not show the hinges 32a that can be provided to assist folding during delivery. FIG. 2C is similar to FIG. 2B but shows the selective occlusion device 22 when the cardiac cycle is in diastole. In systole, FIG. 2A ,​​2B and 3A), it is intended that when the native mitral valve 16 is assumed to be fully closed to prevent blood flow back into the left atrium 12, pressurized blood will flow through the open end 45 of the flexible membrane and at least to a substantial extent prevent flow through the closed end 47. It will be appreciated from a review of some embodiments that a small vent can be provided in the flexible membrane. Because the flexible membrane is along FIG. 2B the direction of the arrows shown in FIG. 3B, the native mitral valve leaflets 16a, 16b will seal against or coapt with the flexible membrane 44 to prevent blood flow regurgitation. In this manner, the mitral valve leaflets 16a, 16b, which would not otherwise seal together or coapt properly, will seal against the flexible membrane 44 during systole. To ensure coaptation, one or more portions of the flexible membrane 44 adjacent the frame structure 30 will move away from the adjacent frame structure to come into contact with the native valve leaflets 16a, 16b. In other words, only a portion of the lower edge of the flexible membrane 44 is attached to the frame structure 30. As shown in FIG. 3B, the flexible membrane 44 is shown in a collapsed or deflated state. The flexible membrane 44 is shown in a collapsed or deflated state in FIG. 3B. The flexible membrane 44 is shown in an inflated or expanded state in FIG. 3A. FIG. 2B Further shown, there can be additional membrane material near the membrane support members 38, 40 to allow for an inflated membrane condition. As shown in FIG. 3B, the flexible membrane 44 is shown in a collapsed or deflated state. The flexible membrane 44 is shown in an inflated or expanded state in FIG. 3A. FIG. 2C and 3B Further shown, when the cardiac cycle is in diastole and blood flow is required to occur from the left atrium 12 into the left ventricle 14 (during the filling portion of the cardiac cycle), blood will push through the flexible membrane 44 and the flexible membrane 44 will enter a collapsed or deflated state as the native mitral valve leaflets 16a, 16b move apart or away from each other in the opposite direction to facilitate blood flow in the direction of the arrows. The arched membrane support members 38, 40 maintain a spacing between the lower edges or rims of the flexible membrane 44 to force blood to fill the membrane 44 in or inside through the open end 45 during systole, causing the membrane 44 to expand or bulge outwardly so that the membrane 44 fills the gap between the native mitral valve leaflets 16a, 16b. The arched or curved support members 38, 40 and / or other portions of the frame structure 30 can be formed using a central wire and a fabric covering around the wire. Other constructions are possible, such as using a soft sponge-like material, and using fabric in combination with a more structurally supportive material, such as metal and / or plastic. The filling and emptying of the flexible membrane 44 through the open end 45 can ensure that the underside of the membrane 44 is washed or rinsed with each heartbeat to prevent clot formation and to prevent any embolic material from being created.

[0154] FIG. 4A and 4B respectively similar to FIG. 1B and 1C but showing the selective occlusion device 22 (FIG. 3B) isolated from the native mitral valve 16. FIG. 1B and 1C .

[0155] FIG. 5A to FIG. 5DAnother embodiment of a selective occlusion device 22a is shown. As previously mentioned, all like reference numerals between embodiments and figures represent like structure and function except to the extent described herein. Some reference numerals will have a suffix modification, such as a letter (e.g., "22a") or an apostrophe (e.g., 90'), indicating a modification to like structure, which will be discussed and / or apparent from a review of the figures. For brevity, redundant descriptions of like structure and function between various figures will not be made or will be reduced to a minimum. This embodiment is particularly suited to achieve the benefits of those mitral valve repairs that involve pinching or otherwise securing one native leaflet edge to the other. However, it should be understood that the clip or other anchor (collectively referred to herein as a clip structure) can be applied to only one leaflet edge, and more than one clip or anchor can be used. Typically, a mitral valve repair is performed with a clip structure 50 having first and second clip elements 50a, 50b that are movable toward each other from an open state to a closed position. The clip structure 50 is typically applied in a transcatheter procedure using a suitable catheter assembly 52. A representative and exemplary clip structure 50 is shown in these figures for pinching the edges of the native leaflets 16a, 16b together near the center of each edge. The beginning of the procedure is shown in FIG. 5A , where the catheter assembly 52 is introduced through the atrial septum 12a transeptally into the left atrium 12, into the mitral valve 16, and to the left ventricle 14. A portion of the edges of each leaflet 16a, 16b are captured by the clip structure 50, which is then pinched and securely fastened together as shown in FIG. 5B . At least one of the first and second clip elements 50a, 50b is moved toward the other in a pinching or clipping action to change from an open state to a closed state. A tensile member 54 (e.g., a wire, suture, or other tensile member, also referred to as a connector) is coupled to the clip structure 50. At or near the end of the pinching step of the procedure, a selective occlusion device 22a in the form of a frame structure 30a and a flexible membrane 44a is introduced through the catheter in a manner similar to that described above with respect to the first embodiment. The selective occlusion device 22a is guided by the tensile member 54 that is attached to and extends from the clip structure 50. FIG. 5D

[0156] As further shown in FIG. 5C , this embodiment of the device 30a, 44a includes two portions 60, 62. This embodiment advantageously utilizes the clip structure 50 as an anchoring mechanism to help secure the device 30a, 44a in place and implanted as a selective occlusion device 22a in the native mitral valve 16. The two portions 60, 62 are employed in the manner described above with respect to the single portion embodiments of the device 30, 44. As will be apparent from a review of the figures, the two portions 60, 62 are coupled to each other by the tensile member 54 that is coupled to the clip structure 50.​FIG. 5C and FIG. 5D As will be appreciated in the context of the browsing of the foregoing, an improved frame structure 30a is employed to support the improved flexible membrane 44a. More particularly, the flexible membrane 44a includes corresponding portions 44al and 44a2. These can be formed from one or more different pieces of membrane material. In addition, third and fourth membrane support members 64, 66 are provided to support the flexible membrane portions 44al and 44a2 in a manner similar and analogous to the manner in which the support members 38, 40 in the first exemplary embodiment described above support and function. An arcuate frame member 32 is shown similar to the first embodiment, which spans the native valve 16. Vertical support members 65, 67 extend from the frame member 32 and are coupled with the membrane support members 64, 66. As another option, the frame member 32 can be omitted and the vertical support members 65, 67 or other structure can be joined together in the central region of the selective occlusion device 22a.

[0157] As further shown in FIG. 5C A tensile member 54, such as a suture or wire, couples the clip structure 52 to the frame structure 30a, for example by use of a crimping element or other fastener 68 generally at the articulation 32a. It will be appreciated that other fastening methods and structures can alternatively be used to secure the clip structure 50 to the frame structure 30a. The clip structure 50 and frame structure 30a can take other forms than the exemplary forms shown and described herein. The use of the clip structure 50 securing the frame structure 30a, in addition to non-penetrating and / or other connectors, for example generally at the native annulus 16c, provides a generally secure implant. The clip structure 50 and one or more annulus connectors will provide opposing forces that securely fix the frame structure 30a and flexible membrane 44a generally between the clip structure and the annulus connectors. The two separate selective occlusion or flow control portions 44al, 44a2 are separated from each other by the clip structure 50. Attachment of the selective occlusion device 22a to the native mitral valve 16 can be a direct connection between the flexible membrane 44a and the native leaflets 16a, 16b (see below). As another option, instead of a single arcuate frame member 32, the two side-by-side portions 60, 62 of the frame structure 30a can additionally be coupled together near the center of the selective occlusion device 22a to avoid the need for a continuous frame member 32 spanning the native mitral valve 16. Further modifications can be made while retaining the advantages of the use of a clip structure in conjunction with the selective occlusion device. For example, the selective occlusion device can be configured as a frame structure and the flexible membrane is attached around a continuous peripheral portion of the frame structure.

[0158] FIG. 6A and 6BFurther embodiments of the selective occlusion device 22b and 22c are shown. In these figures, the flexible membrane 44a is shown in dashed lines so that the respective frame structure 30b, 30c is more clearly shown. In FIG. 6A In the exemplary embodiment, the central hinge is eliminated and the tensile member 54, which is a suture or a wire, extends directly through the frame member 32. As with all embodiments, for the purpose of catheter delivery, the selective occlusion device 22b, 22c and any associated components such as the frame structure 30b, 30c can be made sufficiently flexible and foldable into a collapsed state. Also, a crimping element (not shown) or any other securing means can be used to tensilely secure the tensile member 54, which is a wire or a suture, against the frame structure 30b, 30c. FIG. 6B An embodiment of the selective occlusion device 22c is shown which is slightly different from the embodiment of FIG. 6A The difference is that the flexible membrane 44a, shown in dashed lines, folds inward at the area of the clip structure 50. As FIG. 6A is shown, and as an alternative, the flexible membrane 44a can be more clearly attached to the frame member as shown by the dashed lines extending upward against the vertical support members 65, 67.

[0159] FIG. 7A and 7B are top views showing the selective occlusion device 22c, for example FIG. 6B with the separate portions 44a1 and 44a2 secured in place and implanted within the native mitral valve 16. FIG. 7A shows the selective occlusion device 22c at a diastolic phase of the cardiac cycle, while FIG. 7B shows the selective occlusion device 22c at a systolic phase of the cardiac cycle. The function of a multi-segment device such as with the selective occlusion devices 22a, 22b, 22c is similar to the function of the single segment selective occlusion device 22 discussed above in connection with the first exemplary embodiment, except that the native mitral valve itself is split by the clip structure 50, the separate flexible membrane portions 44a1 and 44a2 acting independently to collapse or contract FIG. 7A during the diastolic phase, and to bulge, deploy or expand FIG. 7B outwardly during the systolic phase due to the forced introduction of blood flow as the cardiac cycle is in the systolic phase. This effect or result is similar to the effects discussed above in connection with, for example FIG. 3A and 3B but with the dual effect of correcting any misalignment or lack of coaptation between the native mitral valve leaflets 16a, 16b on each side of the clip structure 50. In this way, as FIG. 7AAs shown, blood is allowed to flow during diastole through the natural mitral valve leaflets 16a, 16b, which diffuse or expand outwards and also pass through two portions of flexible membrane 44a that contract inwards or away from the natural mitral valve leaflets 16a, 16b. During systole, as the flexible membrane 44a expands or inflates to contact or engage the natural mitral valve leaflets 16a, 16b to form a fluid seal, the reverse or reflux blood flow is at least reduced, if not reduced to substantially zero (blocked).

[0160] FIG. 8 It shows FIG. 7B The selective occlusion device 22c is shown as a side view, but for clarity, the flexible membrane 44a is shown in dashed lines. The selective occlusion device 22c is securely implanted in the mitral valve 16 between the annular connectors 34, 36, typically in an upper position, and the clip structure 50, in a lower position. Similarly, different connector and / or clip configurations as shown and described can be used, and different numbers of connectors and clip structures can be used. As shown, the clip structure can be secured to each leaflet 16a, 16b simultaneously, or it can be secured to individual leaflets 16a and / or 16b separately. Although the tension member 54 is shown with a specific length connecting the clip structure 50 and the frame member 32, tension members or other types of connections of any necessary longer or shorter extent can be used alternatively. In some cases, the clip structure 50 can be directly attached to the frame structure 30.

[0161] FIG. 9 A selective occlusion device 22d constructed according to an exemplary embodiment is shown, in which an alternative configuration of frame structure 30d is used and coupled to a flexible membrane 44 (shown in dashed lines for clarity). Specifically, the lower support members 70, 72, 74, 76 have different configurations for guiding the shape of the flexible membrane 44. The flexible membrane 44 may be securely attached to the lower support members 70, 72, 74, 76 along their entire length, or along a portion of their length, or not at all along the length of the lower support members if they are held in place in an appropriate manner during diastole. The lower edge of the flexible membrane 44 is allowed to bulge or expand outward and may be separated from the lower support members 70, 72, 74, 76 at least substantially to allow such expansion or bulging to occur. Furthermore, the entire frame structure 30d and / or only the lower support members 70, 72, 74, 76 may be highly flexible to allow such expansion or bulging to occur during systole of the cardiac cycle, as previously described.

[0162] FIG. 10A , 10Band 10C show another exemplary embodiment in which the catheter assembly 52 is used and, in particular, the clip structure capture device 80 is used to help secure the selective occlusion device 22a in place. This can be particularly useful when applying a selective occlusion device, such as in accordance with the present disclosure, to a previously implanted clip structure 50. The clip structure 50 can be of any type or configuration. In the event that the clip structure 50 fails to properly repair the mitral valve 16, or in the event that the mitral valve function degrades over time despite the clip repair procedure, this embodiment facilitates capturing the previously implanted clip structure 50 and implanting a selective occlusion device, such as the frame structure 30a and flexible membrane 44a. In this regard, and as shown in FIG. 10A and 10B the lasso or suture loop device 81 is deployed from the catheter 82 and captures the clip structure 50 with the assistance of the guide device 83. The tension member 54 (e.g., suture, wire or other tension member) that extends upward through the mitral valve 16 can be part of the suture loop device 81 in this embodiment, and can then be used to guide and securely affix the selective occlusion device 22a to the clip structure 50 as generally described above, as shown in FIG. 10C For the sake of clarity, the flexible membrane 44a is not shown in FIG. 10C

[0163] FIG. 11A and 11B show two additional embodiments of selective occlusion devices 22e, 22f that do not show a flexible membrane that can be used to prevent blood flow regurgitation through a heart valve, such as through the mitral valve 16. In these embodiments, the flexible membrane 44a( FIG. 11C to 11E ) can be fixedly attached to the frame structure 90, 90' from one end to the other, such as between two non-penetrating annulus connectors, or in other embodiments, between the penetrating connector portions 92, 94, 92', 94'. Advantageously, there are two spaced apart elongated frame members 96, 98 that extend between the connectors 92, 94, 92', 94', each having an upwardly curved or hump 102, 102' that forms a concave space. As FIG. 11C ​As shown, the flexible membrane 44a is carried on the frame structure 90, 90' and can be secured to the frame members 96, 98 along all or some of its length. As generally described above in the previously described embodiments or in the later described embodiments, this can leave a desired portion of the flexible membrane 44a at the lower edge of the unsecured frame structure 90, 90' and able to expand or billow in an outward direction during contraction. This outward expansion or billowing action will allow the flexible membrane 44a to better contact or engage the native leaflet tissue during heart contraction to prevent blood flow regurgitation. This will also allow more blood to exchange under or within the flexible membrane to prevent blood stasis and the resulting coagulation potential that can embolize and cause strokes or other complications. The bulges 102, 102' in each of the lower septal frame members 96, 98 house the clip structure 50 and generally receive the portion of the mitral valve 16 that is secured together at the A2 / P2 junction. A central connecting element, such as a hole 104, is provided in the central frame member 105 and allows the stretch member 54 (e.g., a wire, suture or other stretch member) to attach the frame structure 90, 90' to the clip structure 50. The central frame member connects the annulus connectors 92, 94 and 92', 94' together and arches over and through the mitral valve 16 in a manner similar to the frame member 32. Appropriate configurations of the frame structure 90, 90' can be used, such as any of those described previously, for housing one or more clip structures and forming a plurality of separate flexible membrane portions, e.g., one on each side of the clip structure 50. FIG. 11A and 11B Another way of attaching the frame structure is also shown, generally having one or more holes 106, 106', 106", 106"' at the native annulus 16c to engage with a suitable securing element or anchor 114 FIG. 11D ). FIG. 11B Embodiments of the frame structure 90, 90' include two additional securing holes 106a, 106b for receiving fasteners. In some embodiments, such as that shown in FIG. 11D , a penetrating anchor, such as a rivet, T-bar, wedge or other securing element can be used, although the benefits of a non-penetrating connector according to the present disclosure would be desirable, such as for the purposes of allowing self-adjustment and reducing tissue damage.

[0164] FIG. 12A and 12BAnother exemplary embodiment of a selective occlusion device 22g is shown. This device includes at least one rigid selective occlusion element 120' rather than employing a flexible membrane. This embodiment is more specifically configured for use in conjunction with mitral valve leaflets 16a, 16b that have been attached together at a central location along their edges with a clip structure 50, such as the clip structure previously described. Thus, two selective occlusion elements 120' are provided for reasons similar to the two-part flexible membrane embodiment described herein. The selective occlusion elements 120' are "rigid" when used within the mitral valve 16 in that they are static and do not need to flex inwardly or outwardly to engage and disengage the native mitral valve leaflets 16a, 16b during the systolic and diastolic portions of the cardiac cycle. Rather, these disc-shaped selective occlusion elements 120' maintain their shape and are sized and positioned within the native mitral valve 16 such that the native mitral valve leaflets 16a, 16b engage the selective occlusion elements 120' during heart contraction and disengage the selective occlusion elements 120' during heart relaxation. This selective or cyclical interaction is shown in FIG. 13A and 13B and will be further described below. FIG. 12A and 12B The selective occlusion device 22g shown in

[0165] in FIG. 12A , 12BThe selective occlusion device 22g is shown in FIGS. 13A and 13B when the cardiac cycle is in systole. The native anterior and posterior mitral valve leaflets 16a, 16b are shown pushed inward toward each other. Because the static selective occlusion element 120' fills any residual gap between the anterior and posterior leaflets 16a, 16b, there is no blood leakage or regurgitation. The selective occlusion element 120' does not have to have the shape depicted. Any shape that fills the space between the two leaflets 16a, 16b is sufficient if the gap is filled by the selective occlusion element 120'. The optimal shape can be determined at least in part by studying the shape of the gap between the native mitral valve leaflets 16a, 16b in systole after the clip structure 50 is applied. The optimal shape of the selective occlusion element 120' for a particular patient anatomy can even be custom made for that patient through rapid manufacturing techniques. The advantages of using one or more rigid / static selective occlusion elements 120' include their ability to withstand repeated cyclic forces, possibly better than a design that relies on one or more mobile valve elements that can be more prone to fatigue.

[0166] FIG. 12B A cross-sectional view of the mitral valve 16 is shown more particularly from commissure to commissure. At the commissures, anchor or connector 34, 36 is shown on each side above and below the leaflets 16a, 16b. At the center, there is a clip structure 50 or other attachment that is anchored to the mitral valve leaflets 16a, 16b individually or together. A tensile member 54 or other connecting member extends upward from the clip structure 50 and is attached to a frame member 32 that extends from commissure to commissure across the valve 16.

[0167] The frame structure 30e can be constructed of a metallic material such as stainless steel or nitinol. It can be preferable to use nitinol or other shape memory or super-elastic material because it can be collapsed for catheter delivery through the interior of the heart and then expanded within the interior of the heart for implantation.

[0168] The selective occlusion elements 120' can be constructed in a variety of ways and have a variety of shapes. They can be constructed of a metallic frame, such as nitinol, that can be collapsed for catheter delivery. The metallic frame can be covered with a plastic material or other artificial material such as silicone or Teflon or polyurethane. Animal or human pericardium and animal or human heart valve material or any material typically used in the construction of heart valve leaflets can be used to cover the frame structure 30e. Synthetic or bioengineered materials can also be used to cover the frame structure 30e.

[0169] The interior of the static selective occlusion element 120' can be hollow. Alternatively, a bladder or balloon can be located in the interior to fill the hollow interior space of the selective occlusion element 120'. The bladder can be filled with air or any gas or liquid, such as saline, sterile water, blood, antibiotic or antiseptic fluid, polymer or curable fluid material. The use of a bladder to fill the interior of the selective occlusion element 120' can eliminate or reduce the need for a frame associated with the selective occlusion element 120'.

[0170] The selective occlusion device 22g has commissures and leaflet attachments to anchor it in place. It is also possible to create this device without leaflet attachments. For example, the attachments can only be at the commissures. There is no need to have the clip structure 50 and the members connected to the frame member 32. In this case, there is no need for two selective occlusion elements 120'. A single selective occlusion element 120' can be used to fill any gap between the two leaflets 16a, 16b. Of course, the shape will be different - possibly an elliptical surface that extends between the commissures. The frame for this element can be similar to the frames shown or described in connection with the first embodiment or another configuration.

[0171] FIG. 12C Another exemplary embodiment or variation of a selective occlusion device 22h is shown installed inside the heart to the native mitral valve 16. There are two selective occlusion elements 120' attached to a frame structure 30f. The frame structure 30f is engaged with a clip structure 50 that attaches the anterior leaflet 16a and the posterior leaflet 16b together at the center, for example, near the A2 / P2 junction. The frame structure 30f is stabilized at the commissures and the annular region 16c of the valve 16 by connectors 34, 36.

[0172] FIG. 12C The embodiment of FIG. 12A and 12BThe difference here is that the support frame members 32 are not located above the selective occlusion element 120', but are located below the selective occlusion element 120'. In other embodiments, the support frame members 32 are located above the selective occlusion device and point toward the left atrium. In this embodiment, the support frame members 32 are biased downward and toward the left ventricle, generally below the mitral valve 16. In addition, in this embodiment, the frame members 32 can be directly connected to the clip structure 50 that attaches the two leaflets 16a, 16b and the frame structure 30f together. This can allow for a procedure in which the entire device is implanted at once. The clip structure 50, along with the selective occlusion element 120' coupled to the frame structure 30f, can be delivered by a catheter (not shown). The clip structure 50, with or without the rest of the device exposed, can be extruded inside the heart 10 to the outside of the delivery catheter. The clip structure 50 can then be closed over the native mitral valve anterior and posterior leaflets 16a, 16b. The rest of the selective occlusion device 22h can then be released from the delivery catheter, placing the entire device in place. This can simplify the procedure to one step.

[0173] It is also important to note that in previous embodiments, the frame structure has been above the clip structure 50, while in this embodiment, the frame structure 30f is below. It is also possible to have both an upper and lower support frame structure (e.g., by combining two arc-shaped supports in one device). It is also possible to combine the upper and lower arc-shaped supports or frame members, so that the support or frame structure is a complete ring or circle. This can provide further structural strength to the system.

[0174] FIG. 12D is a side view schematically illustrating another exemplary embodiment of a selective occlusion device 22i that includes first and second rigid or static selective occlusion elements 120' coupled with a frame structure 30g. In this embodiment, the rigid selective occlusion elements 120' are directly coupled to the frame structure 30g, which can be a frame member 32 coupled with a clip structure 50. As in previous embodiments, the clip structure 50 can directly couple the respective edges of the anterior and posterior mitral valve leaflets 16a, 16b, or can couple these leaflet edges together against an intermediate spacer (not shown). This can serve to properly orient and position the rigid selective occlusion elements 120' on opposite sides of the clip structure 50 and within the side-by-side opening of the native mitral valve 16 created by the clip structure 50. Optionally, additional connectors 122A, 122B, shown in dashed lines, can be used to help secure the rigid selective occlusion elements 120' in place at the commissures of the mitral valve 16.

[0175] FIG. 13A and FIG. 13BSchematic diagram in cross-section FIG. 12A to FIG. 12D The rigid selective occlusion element 120' shown functions as follows. Specifically, during the systolic phase of the cardiac cycle, the natural mitral valve leaflets 16a, 16b will abut against the rigid selective occlusion element 120' to provide a fluid seal against backflow. FIG. 13B As shown, during diastole, the mitral valve leaflets 16a and 16b will spread out and disengage from the rigid selective occlusion element 120' to allow blood to flow from the left atrium 12 into the left ventricle 14 between the rigid selective occlusion element 120' and the respective natural leaflets 16a and 16b. One or more selective occlusion elements 120' fill any gaps between the anterior and posterior leaflets 16a and 16b. When mitral regurgitation occurs due to incomplete leaflet engagement, the leaflets 16a and 16b are often pulled apart from each other within the plane of the valve 16 (here, left and right). However, as mitral regurgitation becomes more severe over time, the leaflets 16a and 16b tend to be pulled down into the ventricle 14 and separated from each other, which can complicate matters further. Therefore, an superior / inferior gap may also occur when one leaflet 16a or 16b is located in a higher plane than the other leaflet 16a or 16b.

[0176] The advantage of the convex, curved outer surface of the selective occlusion element 120' is that it can be shaped to accommodate a variety of defects that may occur between the anterior leaflet 16a and the posterior leaflet 16b. The convex, curved surface of the selective occlusion element 120' can accommodate leaflet gaps that are in the plane of the valve 16 (left and right in the figure) and perpendicular to the plane of the valve 16 (top and bottom in the figure).

[0177] The selective occlusion device 22g is symmetrical on each side. The selective occlusion elements 120' can also be configured such that they are asymmetrical, i.e., not identical on opposite sides. For example, the posterior leaflet 16b may retract more into the left ventricle 14 than the anterior leaflet 16a. Adjustment in the selective occlusion element 120' on the side facing the posterior leaflet 16b to fill the gap left by the retracted posterior leaflet 16b may be useful. The selective occlusion element 120' can be configured to be more prominent on the side adjacent to the posterior leaflet 16b than on the side adjacent to or facing the anterior leaflet 16a. The shape of one or more selective occlusion elements 120' can be adjustable, for example by adjusting the level of inflation of the hollow interior of the selective occlusion element 120' or other methods, to accommodate any need to fill the gap between the leaflets 16a, 16b that would otherwise result in regurgitation.

[0178] Custom or custom-sized selective occlusion elements 120' can also be made according to the shape of the gap. The gap can be determined by echocardiography or CT, and the appropriate size and shape of the selective occlusion element 120' can be selected based on the measurements obtained by imaging. The shape of the valve defect that needs to be repaired can be more like a cylinder, and a cylinder or a frusto-cylindrical shape can be better at stopping blood flow regurgitation than a lenticular or disc shape of the selective occlusion element 120'.

[0179] The edge of the selective occlusion element 120' facing the incoming blood flow from the left atrium 12 has a tapered surface. This will allow the blood to flow smoothly into the left ventricle and avoid blood trauma or hemolysis, and promote full and unobstructed filling of the left ventricle 14. The edge of the selective occlusion element 120' inside the left ventricle 14 also shows a taper similar to the selective occlusion element 120' inflow area. When the heart starts to contract, the blood will be ejected back towards the selective occlusion element 120', and the native leaflets 16a, 16b will start to move towards the selective occlusion element 120' to create a complete seal - preventing blood flow regurgitation when the heart contracts.

[0180] Additional options are provided and shown in FIG. 13C . The rigid selective occlusion element 120' can be formed in a fluid- effective manner, such as a teardrop shape or other hemodynamic shape, to prevent undesirable blood flow patterns and trauma or hemolysis as the blood flows between the selective occlusion element 120' and the respective mitral valve leaflets 16a and 16b.

[0181] FIG. 14A 、 14B and 14C show further embodiments of selective occlusion devices 22j, 22k, 22l utilizing rigid or static selective occlusion elements 120'. These selective occlusion elements 120' function as discussed above in connection with FIG. 12A to FIG. 12D and FIG. 13A 、 13B . In FIG. 14A , the rigid or static selective occlusion element 120' is coupled to a frame structure 30h that is fixed along the top edge of the selective occlusion element 120'. At each end of the frame structure 30h, a respective commissure connector 126, 128 is provided that includes a connecting element that operates by clamping the mitral valve tissue or other heart tissue therebetween in the same manner as the butterfly element described previously. Additional fixation is provided by the clip structure 50 and a suitable tensile member 54 or other connector such as described previously.

[0182] FIG. 14BAn embodiment of a selective occlusion device 22k is shown in the form of rigid or static selective occlusion elements 120' which are again generally disc shaped and secured together by frame members 32', tensile members 54 and connected clip structures 50.

[0183] FIG. 14C An embodiment of a selective occlusion device 22l is shown in which rigid selective occlusion elements 120' are secured together by a fabric or other structure 129 and further secured to clip structures 50 by tensile members 54 which secure the selective occlusion device 22l to the native mitral valve 16 by a clipping action as previously described.

[0184] FIG. 15A to 15E Another embodiment of a selective occlusion device 22m is shown which includes a flexible membrane 44a and a frame structure 30i. The flexible membrane 44a is secured to the frame structure 30i which is also preferably flexible for reasons such as previously described. This embodiment is similar to the previous embodiment with a flexible membrane 44a in combination with clip structures 50 but includes a central reinforcing region, for example a reinforcing fabric region 130', which allows the native leaflet edge tissue to be clipped directly to the reinforcing fabric region 130'. The clip structures 50 are shown in dashed lines in FIG. 15E In this alternative, the native mitral valve tissue does not directly contact the abutting native mitral valve tissue but rather contacts and is secured against the reinforcing fabric region 130' of the flexible membrane 44a. Such a fabric or other reinforcing material in the reinforcing fabric region 130' can be useful, for example, where the remainder of the flexible membrane is formed of a more delicate material such as a biological material. As generally shown in the figure, annulus connectors 132', 134' are provided and rest against the upper portion of the annulus 16c so that the clip structures 50 (not shown in this embodiment) secure the selective occlusion device 22m to the reinforcing fabric region 130' from below and the annulus connectors 132', 134' secure the selective occlusion device 22m from above by resting against or otherwise coupling to the native annulus 16c.

[0185] FIG. 16A to FIG. 16D Another exemplary embodiment of a transcatheter delivered selective occlusion device 22n is shown in combination with clip structures 50. Again, the clip structures 50 are used to affix a lower central edge portion of one leaflet 16a to a lower central edge portion of the opposing leaflet 16b, generally as previously described. Again, this clipping action can be to clip the anterior leaflet 16a in direct contact with the posterior leaflet 16b at the central location or to clip the anterior and posterior leaflets 16a, 16b against a central spacer. In this embodiment, the selective occlusion device is coupled with the clip structures 50 which are delivered by one or more catheters. As FIG. 16A and16B As shown, catheter assembly 52 is delivered transeptally into the left atrium 12 and downward through the natural mitral valve, although other methods may be used alternatively in various embodiments. Clip structure 50 is extruded from the distal end of the catheter assembly, and... FIG. 16A Capture as shown in the open state FIG. 16B The leaflet edge portion is shown, and is actuated to move one or both clip elements 50a, 50b together. FIG. 16C The position shown is used to secure the edge portions of the central leaflet together. Then, the remainder of the selective occlusion device 22n is extruded from the distal end of the catheter assembly 52, as shown. FIG. 16C As shown. FIG. 16D As shown, as an illustrative example, it could be FIG. 16D Selective occlusion device 22n of the type shown herein or any other type or even other configuration contemplated herein, is deployed into the mitral valve position. Operation of the selective occlusion device 22n can be generally as described herein, and fixation of the device 22n typically occurs between the clamp structure 50 and the corresponding annular connectors 132', 134'. Specifically, as previously discussed, the annular connectors 132', 134' provide a downward force for substantially fixing the selective occlusion device 22n at the annulus 16c, while the clamp structure 50 provides an upward force for substantially fixing the selective occlusion device 22n in the proper position within the natural mitral valve 16.

[0186] FIG. 17A to FIG. 17C An embodiment of a device for transcatheter delivery and implantation is shown. In this embodiment, typically as described above, a clip structure 50 is delivered below the natural mitral valve 16, and a selective occlusion device 22n is delivered above the natural mitral valve 16. The selective occlusion device 22n is inserted into the natural mitral valve 16 and between the natural leaflets 16a, 16b and also between the clip elements, as... FIG. 17A to 17-B As shown in the method. FIG. 17B As shown, once in place, at least one clamping element moves toward another clamping element to clamp or hold together the leaflet edges, as previously described, and also clamps the lower central portion of the selective occlusion device 22n, and particularly in this embodiment, the flexible membrane 44a, such that the leaflet edges are held together while the selective occlusion device 22n is secured and implanted in the appropriate position within the natural mitral valve 16. FIG. 17C As shown, the selective occlusion device 22n is completely extruded from the catheter assembly, then self-deploys to its position in the natural mitral valve 16 and functions as discussed elsewhere herein. More specifically, FIG. 18A and FIG. 18B The following are examples of combinations.FIG. 17A to FIG. 17C As described, the device is fixed in place during the diastolic and systolic phases of the cardiac cycle. FIG. 18A During diastole, blood flow is allowed between the natural mitral valve leaflets 16a, 16b and the flexible membrane 44a. During systole, the flexible membrane 44a is filled with blood in each section and thus expands or inflates as the mitral valve leaflets 16a, 16b move toward each other and abut against the flexible membrane 44a to form a fluid seal, thereby preventing backflow of blood from the left ventricle 14 of the heart 10 into the left atrium 12.

[0187] FIG. 19 This is an anatomical view from above the natural mitral valve 16, with the selective occlusion device 22n superimposed to show another representation of the structure, wherein the selective occlusion device 22n bends and folds according to the natural curvature of the mitral valve 16.

[0188] FIG. 20 , 21A Figures 21B and 21C illustrate another embodiment of the selective occlusion device 22o and the apparatus (combining the selective occlusion device 22o with the clamp structure 50), wherein the selective occlusion device 22o is generally configured as a two-section device, but the sections are fluidly connected, such as... FIG. 21A As best shown. The clamp structure 50 is secured to the selective occlusion device 22o at a location between the respective open ends 140, 142 of each segment. The clamp structure 50 is used in the same manner as described above. The flexible membrane 44b is supported by a flexible but robust frame structure 143, which can be formed in any manner contemplated herein, for example, to allow for transcatheter delivery and implantation. The open ends 140, 142 are defined by hook or loop portions 145, 147 of the frame structure 143. The hollow interior 144 of the flexible membrane 44b receives blood flow from the contractile portion of the cardiac cycle and fluid communication between the two openings 140, 142, ensuring better flushing or cleaning during the cardiac cycle phase to reduce the chance of blood clots.

[0189] FIG. 22A to 22D Another embodiment of the device for transcatheter delivery and implantation of a clip structure 50 coupled to a selective occlusion device 22p is shown. The difference from this embodiment is that the clip structure 50 clamps the natural mitral valve leaflets 16a, 16b onto the central or intermediate septum 150, rather than directly contacting them. The process is generally... FIG. 22A to 22C As shown, the clip structure 50 is first extruded from the septally guided catheter assembly 52, typically located below the mitral valve leaflets 16a, 16b. FIG. 22B As shown, leaflets 16a and 16b are trapped against the intermediate spacer 150. FIG. 22CAs shown, the leaflets 16a, 16b are securely fixed against the spacer 150 by moving at least one of the clip elements 50a, 50b toward the other. In this embodiment, each clip element 50a, 50b is moved toward the central or intermediate spacer 150 to clamp the leaflet tissue against the spacer 150. In this exemplary embodiment, the selective occlusion device 22p has been secured to the clip structure 50 as it is extruded from the catheter assembly 52, and then the selective occlusion device 22p self-deploys into the implanted state as shown. FIG. 22C As shown, the selective occlusion device 22p has been secured to the clip structure 50 as it is extruded from the catheter assembly 52, and then the selective occlusion device 22p self-deploys into the implanted state as shown. It will be appreciated that the selective occlusion device 22p can be extruded and implanted as a separate component, and can be coupled to the clip structure 50 in a suitable manner, rather than being extruded in the form in which it has been assembled from the catheter assembly or catheter. FIG. 22D As shown, the selective occlusion device 22p has been secured to the clip structure 50 as it is extruded from the catheter assembly 52, and then the selective occlusion device 22p self-deploys into the implanted state as shown. It will be appreciated that the selective occlusion device 22p can be extruded and implanted as a separate component, and can be coupled to the clip structure 50 in a suitable manner, rather than being extruded in the form in which it has been assembled from the catheter assembly or catheter.

[0190] FIG. 22E Another embodiment similar to that shown in FIG. 22D is shown, but further shows respective annulus connectors 154, 156 in the form of frame members that generally abut heart tissue at the annulus 16c in the left atrium 12, and additionally or alternatively, frame members or annulus connectors 158, 159 (shown in dashed lines) that couple with the selective occlusion device 22p and are located in the left atrium 12 to abut the annulus 16c from below. The use of both sets of annulus connectors 154, 156, 158, 159 results in clamping heart tissue therebetween for better securement.

[0191] FIG. 22F Another embodiment of a selective occlusion device 22q is shown, similar to FIG. 22E but showing a single annulus connector 164 that is formed as part of the selective occlusion device generally around the native mitral valve 16 and securely anchors the selective occlusion device 22q in the native mitral valve 16 against any direction of rocking, but allowing flexibility. As with all embodiments, the frame members can be formed of any desired material, such as a flexible wire-like material formed of a polymer and / or including a super-elastic or shape-memory material. This can help achieve the overall goals of embodiments for collapsed delivery for implantation and improved flexibility of operation during use, as well as resistance to failure due to fatigue in this application that involves continuous circulation in the heart.

[0192] FIG. 22G Another embodiment of a selective occlusion device 22r is shown. The selective occlusion device 22r can be as described in connection with any other embodiment, but is shown for exemplary purposes with a hollow flexible membrane 44b, while the frame structure has been modified as shown. The frame structure includes a flexible membrane 44b that is coupled to the frame structure 44a, such as described in connection withFIG. 22F The generally annular frame member 170r is described and shown, but includes raised portions 170a, 170b relative to other portions. The raised portions 170a, 170b are configured to be positioned near and above the commissures of the native mitral valve 16 and to connect with a central frame member 32 (such as with another connecting frame member 172) that extends generally across the native mitral valve 16 and is formed as part of the selective occlusion device 22r. As with all embodiments, such frame members at the annulus can be above the annulus, below the annulus, or the frame members / connectors can be both above and below the annulus to sandwich tissue therebetween.

[0193] FIG. 23A And 23B The selective occlusion device 22s is shown schematically, coupled with a central clip structure 50 that includes a spacer 150 implanted in the mitral valve 16. FIG. 23A The selective occlusion device 22s and the mitral valve 16 are shown when the cardiac cycle is in systole, while FIG. 23B The mitral valve 16 and the selective occlusion device 22s are shown with the heart in diastole. The frame structure includes respective hooks or loops 180s, 182s, as shown in FIG. 23A in solid lines and FIG. 23B in dashed lines. These define the openings 140, 142. The advantage of this frame configuration is that the frame will not contact the commissures during repeated cardiac cycles. Like other embodiments, the device allows blood to flow from the left atrium to the left ventricle during diastole, but prevents blood flow during systole.

[0194] FIG. 24 is a cross-sectional view schematically showing the mitral valve 16 and an implanted selective occlusion device 22s coupled with a central clip structure 50, such as at the coupling 183. The type of selective occlusion device 22s is a hollow interior 144 with two fluidly communicating portions 184, 186 and respective first and second openings 140, 142 and a closed end 188. The fluid communication between the portions 184, 186 allows for better rinsing and washing action and reduces the chance of clotting.

[0195] FIG. 25A And 25B is a schematic of a selective occlusion device 22t, 22t' that includes flexible membranes 44b, 44b', and FIG. 25A And 25BThe selective occlusion devices 22t, 22t' are shown at a cardiac cycle in systole. The difference between the two selective occlusion devices 22t, 22t' is that the flexible membrane 44b' is integrated into the spacer 150 of the clip structure 50, whereas the flexible membrane 44b is not. The flexible membrane 44b and / or another portion, such as the frame portion, of the selective occlusion device 22t can additionally be coupled to the clip structure 50 in the manner shown or another suitable manner. FIG. 24

[0196] FIG. 26A , 26B Another example embodiment of an apparatus including a central clip structure 50 FIG. 26B ) and a selective occlusion device 22u is shown schematically in FIGS. 26A and 26C. The selective occlusion device 22u, like the previous devices shown and described herein, is a hollow fluid communication structure having a flexible membrane 44b and allows blood to flow into the hollow interior 144 defined by the flexible membrane 44b in systole, as shown in FIG. 26B and FIG. 26C In diastole, the flexible membrane 44b collapses inwardly, as shown and described previously, to allow blood to flow through the selective occlusion device 22u and from the left atrium 12 into the left ventricle 14 between the native mitral valve leaflets 16a, 16b. In this embodiment, the orientation of the openings 140, 142 and the shape of the selective occlusion device 22u force blood to flow toward the commissure region in systole as shown by the arrows. These forces, in addition to any other fixation such as the clip structure 50, also help to hold the selective occlusion device 22u in place. In this manner, the selective occlusion device 22u can be reduced in its wobble and can be more stable during implantation and use. These inlets 140, 142 are at an acute angle to the central clip structure 50, as shown in FIG. 26B .

[0197] FIG. 26D ​Another embodiment of a selective occlusion device 22v is shown in which a suitable baffle structure 190v is provided within the selective occlusion device 22v for directing blood flow as shown by the arrows outwardly toward the junction between the selective occlusion device 22v and the mitral annulus 16c. This helps to create a fixation force and stability of the selective occlusion device 22v in the implanted state. A single opening 192 is provided for flow during heart contraction, and the selective occlusion device 22v includes a closed end 194 and a hollow interior 195 so that the selective occlusion device 22v fills with blood during heart contraction and collapses to expel blood during heart relaxation as previously shown and described. The frame structure 196 is provided to support the flexible membrane 44b as previously described, except that the shape and configuration of the frame structure is different to form a single opening 192 defined by a hook or ring shaped frame member 197. It will be understood that the shape and configuration of these structures can be modified from the shapes and configurations shown in these example embodiments.

[0198] FIG. 26E An embodiment of a selective occlusion device 22w is shown, which can be configured as the previous embodiments, but includes a generally ring or circular shaped frame 200 structure that is a flat element for securing the device in place in the mitral valve 16. The frame structure 200 is shown resting and / or secured in the left atrium 12 against heart tissue generally proximate the mitral annulus 16c. However, it will be understood that this structure can be secured in other ways, and additional lower supports can be provided to sandwich heart tissue therebetween.

[0199] FIG. 27A to 27C Another embodiment of a selective occlusion device 22x is shown that can be configured according to the previously described embodiments, but includes at least one small vent 202 opposite two openings 140, 142 of the flexible membrane 44b. The vent 202 is not sized large enough to cause any significant blood backflow or leakage during heart contraction. To some extent, the vent 202 does not allow any significant blood flow back, this end of the flexible membrane is closed, while the opposite end includes at least one opening, and in this embodiment, two openings 140, 142. Otherwise, this embodiment of the flexible membrane 44b operates and functions in the purposes and manners as previously shown and described. The one or more vents 202 can provide, for example, pressure relief to reduce the force on the selective occlusion device 22x during the high pressure contraction portion of the cardiac cycle.

[0200] FIG. 28A to 28CAnother embodiment of the device is shown, which includes a central clip structure 50 and the selective occlusion device 22p described previously. In this embodiment, the clip structure 50 includes a central grasping structure 210, which can have tines or other embossed, roughened or frictional surfaces. This will help to grip and hold mitral valve leaflet edge tissue between the respective clip elements 50a, 50b and the selective occlusion device 22p. The clip structure 50 is secured to the selective occlusion device 22p, for example, via the central grasping element 210. FIG. 28B and 28C It is further shown that the selective occlusion device 22p operates in the same manner, for example, as described above, in fluid communication between two generally adjacent openings 140, 142 for enhanced washing and rinsing.

[0201] FIG. 29A , FIG. 29B and FIG. 30 It is shown FIG. 28A to 28C operation of the device shown after being implanted in the mitral valve 16. Specifically, blood enters the selective occlusion device 22p through the open ends 140, 142 and fills the interior 144 defined by the flexible membrane 44b, whereupon the flexible membrane 44b unfolds or expands into contact with the native mitral valve leaflets 16a, 16b to form a fluid seal that prevents blood flow regurgitation during systole FIG. 29A and 29B ). This is shown in FIG. 29B , where it is further shown the anatomical structure of the mitral valve 16, and the native leaflet tissue contacts the outer surface of the flexible membrane 44b during systole of the heart.

[0202] FIG. 31 Another embodiment is shown, which shows a deployable prosthetic heart valve 220, which can include a generally cylindrical outer or peripheral frame structure 222, and is coupled with an internal prosthetic valve leaflet 224, which opens and closes to control blood flow therethrough. This differs from other forms of the selective occlusion device having at least one movable valve element, for example, a flexible membrane that operates in conjunction with the native mitral valve leaflets, in that the prosthetic heart valve 220 does not operate in conjunction with the native leaflets to control blood flow. Rather, the prosthetic valve leaflet 224 controls blood flow through the prosthetic valve 220. Coupled to the frame structure 222 is a clip structure 50 or elements that directly couple the deployable prosthetic heart valve 220 to the heart valve leaflets, for example, the mitral valve leaflets 16a, 16b shown and described previously. FIG. 32A is a partially exploded side view to show the internal stent structure 226 exposed beneath an outer covering 230, which can be native, synthetic, biological, bioengineered or any other suitable medical grade material that can be used for this type of heart device.

[0203] FIG. 32B to 32E Demonstrates the use of implantation FIG. 31 and 32A The artificial valve 220 involves a series of steps. Specifically, the device can be implanted via transcatheter surgery or more invasive procedures, such as open surgery or keyhole-type or other less invasive procedures. FIG. 32B As shown, the concave or folded device 220 is inserted between the mitral valve leaflets 16a and 16b, and the clamp structure 50 is used to capture the lower edges of the mitral valve leaflets 16a and 16b. FIG. 32C And as FIG. 32D Clamp them as shown. FIG. 32E As shown, the deployable artificial heart valve 220 is then deployed against the natural mitral valve leaflets 16a, 16b to secure the implanted artificial heart valve 220 in the appropriate position within the natural mitral valve 16. The artificial valve leaflets 224 then open and close during diastole and systole, respectively, to allow and prevent blood flow through the artificial heart valve 220.

[0204] FIG. 33 Another embodiment similar to the previous embodiment shown in FIG. 32 is illustrated, but with the addition of an upper flange element 236, which helps to secure the artificial heart valve 220 by stabilizing the heart valve 220 within the left atrium 12. In this respect, the flange 236 is mounted above the natural mitral valve 16. The flange 236 may abut against cardiac tissue in the lower part of the left atrium 12. FIG. 34A yes FIG. 33 The side view of the artificial heart valve 220 shown. FIG. 34B This is a diagram showing an artificial heart valve 220 positioned within the natural mitral valve 16.

[0205] FIG. 35A and 35B Another embodiment of the selective occlusion device 22y installed in the natural mitral valve 16 is shown in cross-sectional view. As in other embodiments, this embodiment includes a flexible membrane 44c having an open end facing the left ventricle 14 and receiving blood flow from below during the systolic phase of the cardiac cycle. FIG. 35A During this part of the cardiac cycle, the flexible membrane 44c expands against the natural leaflets 16a, 16b to reduce regurgitation, as previously discussed. During diastole, the flexible membrane collapses and drains the blood within it. FIG. 35B). Blood then typically travels in the opposite direction through the mitral valve 16 by flowing between the native leaflets 16a, 16b and the outer surface of the collapsed membrane 44c. This embodiment differs from the other embodiments in that multiple clip structures 50 are used to secure the selective occlusion device 22y directly to the leaflets 16a, 16b. The leaflets 16a, 16b are not clipped together with each other. It will be appreciated that in this embodiment as well as the other embodiments, additional clip structures 50 can even be used. In this embodiment, one clip structure 50 secures one side of the flexible membrane 44c to the anterior leaflet 16a, while another clip structure 50 secures the flexible membrane 44c to the posterior leaflet 16b.

[0206] As described above with reference to FIG. 31 to 34B Blood flow through a native valve can be controlled by an artificial valve that is engaged with the native valve device by coupling the artificial valve to each leaflet of the native valve and between the leaflets of the native valve, for example by means of clips that engage each leaflet and secure it relative to a frame of the artificial valve. Artificial valves, such as those used for transcatheter aortic valve implantation (“TAVI”) or transcatheter aortic valve replacement (“TADR”), have proven to be reliable and effective. Artificial valves such as the CoreValve Evolut valve offered by Medtronic and the Sapien valve offered by Edwards Lifesciences are representative. They have a metal stent or frame body, which can be balloon-expandable (e.g. cobalt-chrome) or self-expanding (e.g. nitinol), that can support a three-leaflet artificial valve set (typically formed from animal tissue, e.g. pericardium or native animal leaflets).

[0207] As described in more detail in the following embodiments, artificial valves can also be used to control blood flow through a native heart valve on which an edge-to-edge approximation (e.g. using a clip such as the MitraClip TM or PASCAL) is performed that changes the native valve orifice between the native valve leaflets. For ease of illustration and explanation in the following description, the native valve is a mitral valve, i.e. a two-leaflet valve having an anterior leaflet and a posterior leaflet, but the devices and procedures described below can also be used or adapted for use with other native valves having three native leaflets, such as the tricuspid valve.

[0208] For reference, FIG. 36AA native mitral valve MV is shown, with a posterior leaflet PL and an anterior leaflet AL. The posterior leaflet PL has three segments or scallops: PI (anterior or inner scallop); P2 (middle scallop); P3 (posterior or outer scallop). The anterior leaflet AL has three corresponding segments: Al (anterior segment); A2 (middle segment); A3 (posterior segment). The corresponding segments or scallops of the anterior leaflet join one another to prevent regurgitation through the valve during systole (from the left ventricle LV into the left atrium LA) - in FIG. 36A which the leaflets are shown coapted, i.e. in the position they occupy during systole. The two leaflets AL and PL meet at two commissures, namely the posteromedial commissure PMC and the anterolateral commissure ALC. The leaflets extend from the mitral annulus MVA FIG. 36A (not shown in the figure).

[0209] For further reference, FIG. 36B A native tricuspid valve MV is shown, with a posterior leaflet PL, an anterior leaflet AL, and a septal leaflet SL. In FIG. 36B which the leaflets are shown coapted, i.e. in the position they occupy during systole. The leaflets meet at three commissures: the anterior leaflet AL meets the septal leaflet SL at the anteroseptal commissure ASC; the septal leaflet SL and the posterior leaflet PL meet at the posteroseptal commissure PSC, and the posterior leaflet PL meets the anterior leaflet AL at the anteroposterior commissure APC.

[0210] For further reference, FIG. 37A A native mitral valve MV is shown schematically. In this figure, the edges of the leaflets AL and PL are shown in solid line when the heart is in systole, i.e. the leaflet edges are coapted to one another, (for a competent native valve) blocking retrograde blood flow, and in dashed line when the heart is in diastole, i.e. the leaflets are spaced apart, allowing antegrade blood flow from the left atrium LA to the left ventricle LV.

[0211] FIG. 37B to 37D A native mitral valve MV is shown schematically with one or more clips CL performing edge-to-edge approximation thereon. As FIG. 37B shown, a single clip CL has been set centrally to approximate the edges of the anterior leaflet AL and the posterior leaflet PL at their respective A2 and P2 segments. This creates two flow control portions, through which blood can flow during diastole: FCP1, which is bounded by the anterior leaflet AL, the posterior leaflet PL, the clip CL, and the posteromedial commissure PMC; and FCP2, which is bounded by the anterior leaflet AL, the posterior leaflet PL, the clip CL, and the anterolateral commissure ALC. Similarly, as FIG. 37C shown, a single clip CL has been set eccentrically in the native leaflets. Two flow control portions FCP1 and FCP2 are created, but they are substantially different in size. In the extreme case of eccentric or off-center clipping, the smaller flow control portion (e.g. FIG. 37CThe FCP1 in the sample can be of negligible or insignificant size to ensure treatment. Therefore, placing a single clamp CL may result in a single, larger flow control unit. For example... FIG. 37D As shown, the two clips are spaced apart from each other to approximate the edges of the anterior leaflet AL and the posterior leaflet PL. This creates three flow control zones through which blood can flow during diastole: FCP1, defined by the anterior leaflet AL, the posterior leaflet PL, the clip CL, and the posteromedial commissure PMC; FCP2, defined by the anterior leaflet AL, the posterior leaflet PL, the clip CL, and the anterolateral commissure ALC; and FCP3, defined by the anterior leaflet AL, the posterior leaflet PL, and the two clips CL.

[0212] FIG. 38A to 38F A natural tricuspid valve TV on which edge-to-edge approximation is performed is schematically shown. FIG. 38A and 38B A natural tricuspid valve TV is shown, on which two clips (e.g., TriClip) have been attached. TM The "three-hole" clamping technique was performed. FIG. 38A The tricuspid valve TV during systole is shown, and FIG. 38B The tricuspid valve (TV) is shown in diastole. One clip CL connects the anterior leaflet AL and the septal leaflet SL, while another clip CL connects the posterior leaflet PL and the septal leaflet SL. This clipping technique creates three flow control sections through which blood can flow during diastole: FCP1, defined by the anterior leaflet AL, the posterior leaflet PL, the septal leaflet SL, the two clips CL, and the anterior-posterior septal commissure APC; FCP2, defined by the anterior leaflet AL, the septal leaflet SL, one clip CL, and the anterior septal commissure ASC; and FCP3, defined by the posterior leaflet PL, the septal leaflet SL, one clip CL, and the posterior septal commissure PSC.

[0213] FIG. 38C and 38D This illustrates a natural tricuspid valve TV on which "mitralization" clipping has been performed using two or more clips CL. FIG. 38C The tricuspid valve TV during systole is shown, while FIG. 38D The tricuspid valve TV is shown in diastole. All clips CL connect the anterior leaflet AL and the septal leaflet SL. This clipping creates a large flow control section, FCP1, that allows blood to pass through during diastole. This section is defined by one of the anterior leaflet AL, the posterior leaflet PL, the septal leaflet PL, and one of the clips CL, the anterior-posterior commissure APC, and the posterior septal commissure PSC.

[0214] FIG. 38E and 38F A natural tricuspid valve TV is shown, in which a "triple-clamp variation" clamping procedure is performed using three clips (CL). FIG. 38E The tricuspid valve TV during systole is shown, while FIG. 38FThe tricuspid valve TV during diastole is shown. A clip CL connects the anterior leaflet AL and the septal leaflet SL, a clip connects the septal leaflet SL and the posterior leaflet PL, and a clip connects the posterior leaflet PL and the anterior leaflet AL. The clipping also creates a large flow control portion - FCP1 - through which blood can pass during diastole, which is similar to, but smaller than, the opening of the native tricuspid valve before the clipping procedure. Thus, the flow control portion FCP1 is bounded by the anterior leaflet AL, the posterior leaflet PL, and the septal leaflet SL, but not by the three natural commissures, but rather by the three clips CL.

[0215] As described above, the purpose of the edge-to-edge approximation using one or more clips (such as the MitraClip TM , TriClip TM , or PASCAL) is to repair a native valve that is unable to sufficiently prevent regurgitation (i.e., backflow) during systole. The clipping can reduce or ideally eliminate such backflow. However, experience has shown that regurgitation can still occur in the flow control portion(s) FCP resulting from the clipping, whether immediately after the procedure or over time (e.g., as the heart dilates and the corresponding native valve annulus size, or the native valve leaflets, contract). In the above-described embodiments, a selective occlusion device can be provided in the flow control portion(s) to reduce or eliminate the regurgitation. The selective occlusion device can be engaged with the clip to hold or help hold the device in a desired position relative to the native valve and flow control portion. The selective occlusion device can also be supported relative to the native valve by virtue of one or more structures that engage with the annulus of the native valve and / or other structures of the native valve device. In the embodiments described below, a prosthetic valve can be provided in the flow control portion(s). Devices and systems incorporating such prosthetic valves can employ similar structures and techniques for engaging with the clip and / or the native valve device to hold the prosthetic valve in place.

[0216] One embodiment of a prosthetic valve 100 is shown schematically in side view and top view in FIG. 39A and 39B , respectively. In the following description, some of the reference numbers used are the same as in the previous description. The reference numbers used below are intended to remain internally consistent, and thus no correspondence should be inferred between the structure or function of elements having the same reference numbers in the previous and following descriptions. As FIG. 39A and 39BAs shown, the prosthetic valve 100 includes a main body 110 having an inlet portion 112, a transition portion 113, and an outlet portion 114. The outlet portion 114 includes a first limb 116 and a second limb 117, and can optionally include a third limb 118. The main body 110 defines a flow passage 130 therethrough, including a flow control passage 132 in the inlet portion 112, a branch or transition passage 133 in the transition portion 113, a first limb passage 134 in the first limb 116, and a second limb passage 136 in the second limb 117, and can optionally include a third limb passage 138 in the optional third limb 118.

[0217] All portions of the flow passage 130 are in fluid communication with one another, and can pass fluid (e.g., blood) from an inlet 131 at the inlet portion 112 of the flow passage 130, through the flow control passage 132, through the transition passage 133, and through the first limb passage 134 from a first outlet 135 at the outlet of the first limb passage 134, or through the second limb passage 136 from a second outlet 137 at the outlet of the second limb passage 136, and optionally through the optional third limb passage 138 from a third outlet 139 at the outlet of the optional third limb passage 138.

[0218] Flow through the flow passage 130, and in particular through the flow control passage 132, is controlled by a flow control device 160. The flow control device 160 can be similarly configured and function as the known prosthetic valves described above, and can be implemented as a tri-leaflet valve having three leaflets. Other valve structures can be suitable, including valves having fewer than three leaflets, which can coapt with a fixed structure in the valve in addition to, in addition to, or in lieu of coaptation with other leaflets, as described in greater detail in particular embodiments below. As FIG. 39A to 40B Illustratively, the flow control device 160 can be cylindrical, having a circular cross-section. The flow control device 160 can be mounted to the inlet portion 112 of the main body 110, and disposed such that all flow through the flow control passage 132 must pass through the flow control device. The flow control device 160 is configured to allow fluid to flow therethrough in a direction from the inlet 131 to the outlets 135, 137, and optionally 139, but to prevent fluid flow in the opposite direction.

[0219] As is known, tissue valves can fail, and it is also known that this problem can be addressed by delivering another tissue-based stent valve within the failed valve. Thus, it is contemplated that if the flow control device 160 fails, a new tri-leaflet valve can be placed within the flow control device 160.

[0220] The prosthetic valve 100 also includes a clip connector 170 that is part of or coupled to the main body 110 and is configured to engage with a clip, such as the clip described above, to thereby maintain the prosthetic valve 100 in operative relationship with the native heart valve to which the clip is attached. In particular, the clip connector 170 is configured to transfer the fluid dynamic loads applied to the prosthetic valve 100 during the cardiac cycle of the heart to the clip CL, and thereby to the native leaflets, annulus, and surrounding heart tissue, to resist displacement of the prosthetic valve. The maximum load to be borne tends to be during systole, while the displacement to be resisted is toward the atrium.

[0221] The clip connector can be implemented in various configurations, including those described above in connection with the many embodiments of the selective occlusion device, to couple a frame structure (which can be similar to the main body frame 120 and / or the annulus connector 180) to a clip structure, for example in FIG. 5C-5D with the tensile member 54, FIG. 12C-12D with the frame member 32 directly connected to the clip 50, FIG. 14A-14C with the rod-like connector, FIG. 15A-15E and FIG. 27A-27C with the clip having the reinforced fabric region 130' directly engaging the flexible membrane 44a or 44b.

[0222] FIG. 40A and 40B respectively show the prosthetic valve 100 placed in a native heart valve in side and top views. Note that for ease of illustration, FIG. 40A and 40B show the prosthetic valve 100 without the optional third leaflet 118 and associated third leaflet passage 138 and third outlet 139, and show the native heart valve as a mitral valve MV. Similar to the mitral valve MV shown in FIG. 37B , the mitral valve MV is shown as having an anterior leaflet AL and a posterior leaflet PL connected by a clip CL in an edge-to-edge approximation. Thus, the mitral valve MV has two flow control portions: FCP1 and FCP2, defined between the clip, leaflets, and commissures of the mitral valve MV.

[0223] As FIG. 40A and 40BAs shown, the prosthetic valve 100 can be disposed in the mitral valve MV, with the inlet 131 disposed in the left atrium LA and the first outlet 135 and the second outlet 137 disposed in the left ventricle LV. The first leaflet 116 is shown disposed in the flow control portion FCP1 and the second leaflet 117 is shown disposed in the flow control portion FCP2. The clip connector 170 is engaged with the clip CL. The optional annulus connector 180 can be engaged with the mitral valve annulus MVA. When the prosthetic valve 100 is disposed in the mitral valve MV, it is operable to reduce or eliminate regurgitation through the flow control portions FCP1 and / or FCP2, i.e., to prevent blood from flowing from the left ventricle to the left atrium during systole, but to allow blood to flow from the left atrium LA to the left ventricle LV via the prosthetic valve 100 during diastole.

[0224] As noted above, the prosthetic valve 100 can be used in other native heart valves, including other atrioventricular valves, the tricuspid valve. For example, a prosthetic valve with an optional third leaflet can be used in a tricuspid valve that has undergone three-hole clipping, in which each of the three leaflets is treated in each of the three resulting flow control portions, respectively. However, in some cases, it can be preferable to use a prosthetic valve that does not include a third leaflet in such a tricuspid valve, with each of the two leaflets disposed in two of the three flow control portions, and allowing the third flow control portion to function with the native leaflet alone.

[0225] The height of the inlet portion 112 of the prosthetic valve 100, or the total height of the inlet portion 112 and the transition portion 113, can be any suitable distance, although it is desirable that this distance not be too large so as to impede blood flow into the inlet 131, that is, to leave sufficient space above and around the inlet 131 within the heart chamber so that blood can flow freely into it.

[0226] The absolute and relative sizes (cross-sectional areas) of the flow control passage 132 (and the flow control device 160) and the first leaflet passage 134 and the second leaflet passage 136 (and the optional third leaflet passage 138) can be varied to optimize function, to match the anatomy of the heart, cardiac volumes, etc., or to account for other relevant factors.

[0227] Each of the first and second leaflets 116, 117 can be configured such that its outer surface engages the anterior and posterior leaflets in a substantially sealed relationship, thereby reducing or preventing blood flow therebetween during at least a portion of the heart pumping cycle. In some embodiments, each of the first and second leaflets can be sized (e.g., circumference) and configured (e.g., cross-sectional shape is circular, elliptical, ovoid, etc.) to substantially fill or overfill (stretch) the corresponding flow control passage, to maintain the edges of the leaflets in sealing contact with the outer surface of the first and second leaflets throughout the cardiac cycle, thereby preventing flow from the atrium to the ventricle between the leaflets and leaflets during diastole and from the ventricle to the atrium during systole. In this configuration, substantially all blood flow from the atrium to the ventricle during diastole is thus delivered through the prosthetic valve (and thus through the flow control device), and blood flow from the ventricle to the atrium during systole (regurgitation) is substantially prevented (by the flow control device 160). This configuration provides several benefits: first, the native leaflets move little or not at all throughout the cardiac cycle, which will reduce wear from repeated contact between the leaflets and the outer surface of the prosthetic valve leaflets (there is little momentum on the native leaflets when they collide with the leaflets). The native leaflets are pliable, which tends to fill any irregular shape or closure defects. Second, it should be ensured that the valve is completely sealed, i.e., prevents regurgitation. Finally, in patients in which the valve needs to be repaired or replaced, the heart tends to deteriorate over time. For such patients, regurgitation should not occur again because the prosthetic valve effectively takes over the function of the native valve, and the residual valve tissue will be able to fill any gaps that can occur when the heart expands (or any gaps that can occur when the valve leaflets contract as the disease progresses). These advantages are particularly applicable to native valves that have had edge-to-edge clipping applied. After the clip is applied, the total opening size of the valve is limited to the controlled area of the resulting flow control portion, which is smaller than the original opening area of the native valve. Thus, the surface or orifice area that must be occluded by the valve is reduced, and the load on the prosthetic valve is reduced. In many cases, the clip can safely withstand the highest loads generated during heart contraction.

[0228] In another configuration, the leaflets can be sized smaller than the flow control portion, thereby allowing a gap to form during diastole and allowing some blood flow from the atrium to the ventricle through the gap (in addition to the blood flowing through the flow passage and the flow control device). The leaflets are preferably sized to be in close contact with the outer surface of the leaflets during systole, preventing regurgitation between the leaflets and leaflets.

[0229] The leaflets of the prosthetic valve 100 are preferably made of a material that is flexible and / or elastic, such as a polymer or a polymer blend. The leaflets can be made of a material that is more flexible than the material of the flow control device 160, such that the leaflets can be stretched to fill the flow control passage 162 and / or the gap 164. The leaflets can be made of a material that is more elastic than the material of the flow control device 160, such that the leaflets can return to their original shape after being stretched to fill the flow control passage 162 and / or the gap 164. FIG. 39B and 40BThe cross-sections are shown schematically as elliptical. This is because the flow control portion of the native valve caused by the leaflet coaptation can be elliptical or slit-like. By forming the leaflets with corresponding cross-sections, they can better follow the shape of the flow control portion and fill the leakage space. In some embodiments, the cross-sectional shape of the leaflets can be more rounded (circular or elliptical) near the clip, with a teardrop shape (more V-shaped) extending towards the commissure. Although the leaflets are shown schematically in FIG. 39B and 40B as being generally linear, or arranged symmetrically about a centerline through the clip, as shown in FIG. 36A , there is a natural curvature to the line of coaptation of the native mitral valve leaflets. When viewing the anterior leaflet of the mitral valve from above, one can see an upward curve towards the line of closure. To conform to this anatomy, in some embodiments the leaflets of the prosthetic valve can be arranged to follow the curve of the line of coaptation.

[0230] FIG. 39B and 40B schematically show the leaflets 116, 117 (and optionally 118) as being straight and parallel to each other. However, in some embodiments the leaflets can be straight but can be non-parallel, and can be angled towards or away from each other. In other embodiments they can not be straight, but can be arcuate, so that the outlet portion 114 of the body 110 can have a horseshoe shape, similar to the shape of the device shown in FIG. 26B . Similarly, although the space between the leaflets 116, 117 (and optionally 118) is shown as rectangular in the schematic of FIG. 39A and 40A , this space can be arcuate or curved with a large radius of curvature, or can be more acute (more V-shaped).

[0231] The generally tubular leaflets 116, 117 (and optionally 118) are shown schematically in FIG. 39A to 40B . However, in some embodiments it can be useful for the leaflets to flare outwardly (larger perimeter) towards their respective outlets, as this can encourage more blood to enter the flow passage 130 during systole and encourage the leaflets of the flow control device 160 to close. Thus, for example, the outlet end of the leaflets can have a flared bell shape.

[0232] Although the leaflets are shown schematically in FIG. 39B and 40BThe leaflets 116, 117 (and optionally 118) are shown schematically as having flat ends (i.e., at the outlets 135, 137 (and optionally 139)), that is, they are linear and orthogonal to the central vertical axis of the prosthetic valve 100, but in other embodiments the ends of the leaflets can be of any other configuration, including angled and / or arcuate, so long as they can be reliably positioned in the native valve so that preferably the entire outlet is below the location where the native leaflets seal against the leaflets 116, 117 (and optionally 188). The outlets can also have a non-planar outflow perimeter, but rather a scalloped perimeter. For example, the portion of the outflow perimeter that engages the anterior leaflet can extend deeper within the ventricle than the corresponding portion that engages the posterior leaflet. In this way, the upward surge of blood during systole will first contact this deeper extending portion of the outlet and can ensure better systolic filling of the prosthetic valve 100.

[0233] The body 110 can be constructed with materials and techniques similar to known prosthetic heart valves, such as those discussed above. For example, the body 110 can have a body frame 120 formed of wires, struts, mesh, braid, or other suitable structure made of metal (e.g., cobalt-chrome, stainless steel, shape memory metal such as nitinol, etc.), polymer, or other suitable material. The body frame 120 can be formed as a single integral piece in the shape of a Y, or can be constructed of separate pieces that are connected together, such as any of the inlet portion 112, the transition portion 113, the first leaflet 116, the second leaflet 117, and (optionally) the third leaflet 118. Where the body frame 120 is formed as separate components, in embodiments, these components can be delivered and implanted separately to make delivery easier, and then coupled together in place in the heart valve. As described in more detail below with reference to specific embodiments, the body frame 120 need not extend to the outlet portion 114 of the body 110. For example, rigid grafts (such as coated or uncoated dacron, teflon, etc.) can be used without a frame or with minimal frame.

[0234] The construction of the leaflets 116, 117, and (optionally) 118 can vary. In some embodiments, portions of the body frame 120 within the leaflets can be configured with a stent frame, the body covering 122, and / or a body liner 123 that can include or add a cushion (formed of materials such as silicone and pericardium). Making the leaflets more compliant can be useful so that the leaflets move with each heartbeat and reduce wear on the leaflet tissue as it contacts the device. Thus, any or all of the leaflets can be configured similar to the arrangements described above for prosthetic valves, such as FIG. 5D , 7A- the embodiments shown in B, 15A-E, or 18A-B. In such embodiments, the leaflet can be configured with a frame that allows the overlying biocompatible covering (e.g., pericardium) to move anteriorly and posteriorly with each cardiac cycle. In other embodiments, the leaflet can be configured similar to FIG. 13A - the occlusion devices shown in B and FIG. 25A - the occlusion devices shown in B, where the occlusion device is rigid or static, and the native leaflet moves toward the leaflet to seal against leakage and prevent wear.

[0235] In some embodiments, the leaflet of the prosthetic valve can be configured to have its shape adjustable to improve the seal between the leaflet and the native leaflet. For example, after the prosthetic valve 100 has been placed in the native valve, an elliptical balloon or an elliptical stent can be introduced to shape the leaflet. This approach can also be useful if the body covering 122 and / or the body liner 123 on (or within) the leaflet wears. A new body liner 123 can be applied from inside the leaflet, delivered through the flow passage 130 onto the stent or frame. This approach will be particularly useful if the leaflet is constructed with segments of little or no frame material.

[0236] The flow control device 160 is coupled to and supported by the body frame 120 in the inlet portion 112, or can optionally form part or all of the inlet portion of the body frame 120 and be coupled to the transition portion 113.

[0237] The body frame 120 can be covered externally with a body covering 122 and / or internally with a body liner 123, each of which can be formed of any suitable material that is biocompatible, sufficiently impermeable to the fluid, such as blood, to form and maintain the flow passage 130 within (or outside of) the flow passage 130, and to non-traumatically contact the native valve tissue (leaflet, chordae, heart chamber wall, etc.) with the body frame 120. Suitable materials can include animal pericardium and synthetic materials, such as Dacron polyester (the latter material can be more suitable for covering areas of the body frame 120 that do not contact heart tissue as it can wear somewhat).

[0238] The main cover 122 and / or main liner 123 may cover or line the entire main frame 120, or they may be discontinuous and cover only a portion of the main frame 120. Each may also be continuously attached to each region of the main frame 120 it covers or lines, but may also be attached around the periphery or edge of selected regions on the main frame 120, without being attached to those regions. This configuration allows blood to pass between struts, for example, in the main frame 120, and causes the main cover 122 and / or main liner 123 to expand / inflate outward, thereby gently contacting the natural valve leaflets. The natural leaflets will abut against the material of the main cover 122 and / or main liner 123 (e.g., the pericardium), which is supported by blood within the flow channel 130, rather than by a solid portion of the main frame 120. The main frame 120 may be formed with struts that are widely spaced in the contact area to ensure that the main cover 122 and / or main liner 123 will be expanded by blood. This can significantly reduce wear on the natural valve leaflet tissue.

[0239] like FIG. 39A As shown (but for ease of explanation, from...) FIG. 40A (omitted), the body 110 may also include an outlet flange 124 located at the outflow ends of the flaps 116 and 117 (and optionally, not shown on flap 118), which includes a filler material to reduce the risk of injury to cardiac tissue that may come into contact with those portions of the body frame 120 during the cardiac cycle. This filler material can be any available biocompatible material. Silicone, polyurethane, biopolymers or bioelastomers, polyester, and PTFE (Teflon) fabrics (often used in rolled or folded forms for suture flanges of prosthetic valve suture loops) are suitable choices commonly used in valve structures. This filler material or damage-reducing material can be added to any portion of the prosthetic valve 100.

[0240] In some embodiments, the flow channel 130 may include features to guide fluid (e.g., blood) through the artificial valve 100. For example, similar to the above. FIG. 26D The flow diversion performed by the baffle structure 190v, pushing the fluid toward the sidewall of the flow channel 130 (e.g., in the transition channel 133), may be useful. (As in combination...) FIG. 26D As described, the hydrodynamic forces guided to the sides of the artificial valve 100 can reduce the risk of swaying. Alternatively or additionally, similar to the above reference... FIG. 26D The described method allows fluid (e.g., blood) flowing through flow channel 130 to be mixed with a spiral component, for example, disposed in transition channel 133. Mixing the fluid around the spiral component reduces sloshing on the artificial valve 100 by dissipating energy and focusing the flow toward flow control device 160. FIG. 39AFigures 1A and IB schematically illustrate structures for performing split-flow and / or mixing as optional splitters / mixers 150 (for ease of illustration, omitted in FIG. 40A Figures 1A and IB).

[0241] Although the above references are made to FIG. 36A to FIG. 40B commercial edge-to-edge leaflet clips, such as the MitraClip or PASCAL, and the prosthetic valve 100 is configured to engage with such a clip after it is used to clip the native leaflets, in some embodiments the clip CL can be configured differently than such a commercial clip, and / or can be included as part of the system with the prosthetic valve 100 and delivered before or concurrently with the prosthetic valve 100 as part of the overall valve repair / replacement procedure. As noted above, the prosthetic valve 100 is configured to anchor to the clip CL, which in turn couples to tissue of the anterior leaflet AL and the posterior leaflet PL, and the prosthetic valve 100 will carry a substantial fluid dynamic load during systole that must be carried by the clip and the leaflets. Thus, an enlarged clip anchor can be useful. For example, the clip can consist of two or three paddles (rather than the PASCAL and MitraClip TM single paddle of the device) to increase the leaflet area engaged by the clip. This allows the dynamic load to be more evenly distributed over a larger leaflet area (and over a greater number of underlying chordae attached to the engaged leaflet portions).

[0242] In some embodiments, these loads can be carried in part by other structures without requiring the clip or native leaflets to be placed in the load path, rather than relying on the clip connector (and thus the clip CL, native leaflets, or other native valve tissue) to carry all of the fluid dynamic loads exerted on the prosthetic valve. Thus, in some embodiments the prosthetic valve can include an optional annulus connector 180 and / or an optional heart tissue tether 190.

[0243] As FIG. 39A to FIG. 40B shown, the optional annulus connector 180 can be part of or coupled to the body 110 and configured to engage with the annulus of the native heart valve (and / or other nearby tissue, including the atrial wall, native leaflets, and / or chordae) to enhance stability of the prosthetic valve 100 when placed in the native heart valve, for example to inhibit lateral rocking of the prosthetic valve and / or displacement away from the annulus toward the atrium (during systole) or the ventricle (during diastole). The annulus connector 180 can be implemented similarly to the annulus connectors described above with reference to various embodiments of the selective occlusion device, including: FIG. 22E(where the annulus connectors 154 and 152 are configured as elongated frame members extending longitudinally from the frame of the selective occlusion device, and can engage the peripheral portion of the mitral annulus, the connector 154 can engage tissue on the atrial side of the annulus, and the connector 158 can engage tissue on the ventricular side of the annulus); FIG. 22F (with a single annular annulus connector 164 coupled to the frame of the selective occlusion device, and can engage substantially the entire circumference of the atrial surface of the annulus, preventing rocking in any direction, but allowing flexibility - this configuration can also be used to engage the ventricular side of the annulus); FIG. 26E (similar to FIG. 22F but the annular annulus connector is configured as a flat element that can be secured to the atrial side of the annulus, and can alternatively or additionally have a similar structure that can be secured to the ventricular side of the annulus). The annulus connector 180 can be configured with non-tissue penetrating members or tissue penetrating members.

[0244] As shown in FIG. 39A to FIG. 40B one or more optional heart tissue tethers 190 can be coupled to the main body 110, the clip connector 170, the clip CL, and / or the annulus connector 180. For ease of illustration, not all options are shown in all figures. The heart tissue tethers 190 can be elongated tension members implemented as metal wires, polymeric sutures (monofilament or braided structure), or other suitable biocompatible materials having sufficient tensile strength to carry the desired portion of the fluid dynamic loads exerted on the prosthetic valve 100. Each such tether can include a suitable anchoring mechanism through which the free end of the tether (opposite the end connected to the prosthetic valve 100) can be secured to heart tissue. Such tether anchors 192 can include any known mechanism for securing a tether or suture to tissue, including heart tissue, such as a pin, a screw, a clip, a suture loop, or an enlarged structure (a pledget, a disc) that can be disposed on the side of the tissue wall opposite the tether body. One or more heart tissue tethers 190 can be coupled to heart tissue including various locations / structures in the ventricle, such as the apex of the ventricle, the ventricular septum, any other wall of the ventricle, one or more papillary muscles, one or more chordae tendinae, and / or the annulus of a native valve.

[0245] The prosthetic valve 100 can be delivered to and positioned in the native valve and secured to the clips CL by the clip connectors, to the annulus (and / or adjacent tissue) by the annulus connectors, and / or to other heart tissue by the heart tissue tethers in various methods and sequences. The delivery, positioning, and / or securing can also be performed as part of an integrated procedure with the edge-to-edge approximation using the clips CL, sequentially after the edge-to-edge approximation in the same interventional procedure, or as a separate procedure for a patient who has previously undergone the edge-to-edge approximation. Reference is made to the method 200 depicted in the flowchart in FIG. 41 Some options are described with reference to the method 200 depicted in the flowchart in FIG. 16. At step 201, one or more clips CL can optionally be delivered to the native valve and used to clip the native leaflets for the edge-to-edge approximation. As described above, this procedure can create two flow control portions, each bounded by a native leaflet, the (or) clip, and the commissure of the native valve. As described above, step 201 can have been performed in a separate procedure in advance, or can be performed as part of the same procedure as a preceding portion of the method 200. At step 202, a leak or regurgitation assessment can be performed on the clipped native valve, and a determination made as to whether any such leak or regurgitation is sufficiently severe as to impact the use of the prosthetic valve 100. At step 203, the extent of the leak or regurgitation, the size of the flow control portions, and / or other relevant clinical information can be determined (e.g., by imaging) to enable selection of an appropriate prosthetic valve (e.g., the size of the leaflets 116, 117 (and optionally 118)). At step 204, the prosthetic valve 100 is delivered to the native valve, e.g., using a delivery catheter by known endovascular techniques. At step 205, the prosthetic valve 100 is set in the native valve with the inlet 131 of the flow passage 130 disposed in an atrium of the heart, with the first leaflet 116 of the body 110 of the prosthetic valve 100 disposed in the first flow control portion FCP1, with the first outlet 135 of the flow passage 130 disposed in a ventricle of the heart, and the second leaflet 117 of the body 110 of the prosthetic valve 100 disposed in the second flow control portion FCP2, with the second outlet 137 of the flow passage 130 disposed in the ventricle of the heart. At step 206, the clip connectors 170 are coupled to the one or more clips CL that are clipped to the native leaflets. In an integrated procedure, the clip connectors 170 can be coupled to the clips CL prior to the clips CL being clipped to the native leaflets for the edge-to-edge approximation.

[0246] Optionally, at step 207, the annulus connectors 180 can be engaged with the native annulus (on the ventricular side and / or the atrial side) and / or adjacent tissue. Although in FIG. 41In the flowchart, 207 is shown as following 206, but in some embodiments, the annulus connector 180 can first engage with the native annulus, i.e. the prosthetic valve is in place in the native valve, and then the clip connector 170 can be coupled to the clip CL. At step 208, also optionally, one or more heart tissue tethers 190 can be engaged with heart tissue at one or more locations in the heart. Further optionally, at the completion of the method 200, or in a subsequent procedure, if some blood regurgitation is identified, and determined to be due to insufficient sealing between the native leaflets in the flow control portion of the native valve and the leaflets 116, 117, then at step 210, one or both of the leaflets 116, 117 of the prosthetic valve 100 can be further expanded or re-expanded to reshape or increase the perimeter of the leaflets and improve the sealing with the native leaflets, as described in more detail below.

[0247] FIG. 42A-42C A prosthetic valve according to an embodiment is shown. The prosthetic valve 300 includes a main body 310 having an inlet portion 312, a transition portion 313, and an outlet portion 314, and first and second leaflets 316, 317. The main body frame 320 includes elongated longitudinal struts 321a on the outside of the main body 320 extending from the inlet 360 to first and second outlets 335, 337, and U-shaped elongated struts 321b between the first and second leaflets 316, 317, interconnected with a series of hoops or rings 321c. The main body 310 also includes outlet flanges 324 at the outlet end of each leaflet. The main body 310 includes a main body covering 322 attached to the entire outer surface of the main body 310. The main body 310 defines a flow passage 330 between the inlet 331 and the first and second outlets 335, 337, including a flow control passage 332, a transition passage 333, a first leaflet passage 334, and a second leaflet passage 336.

[0248] The prosthetic valve 300 also includes a clip connector 370, which in this embodiment is implemented as a meshed construction 371 of extending material between the first and second leaflets 316, 317, and can be clamped between the paddles of the clip CL and the native leaflets of the mitral valve MV. Various embodiments and uses of the clip CL are described below.

[0249] FIG. 42DA clip CL is shown with a first paddle or clamping member PI, a second paddle or clamping member P2 and a spacer SP. The anterior leaflet AL is captured between the first paddle PI and a first tissue gripper TGI that is movable relative to the paddle PI to allow the anterior leaflet AL to be inserted into the free edge between the first paddle PI and the first tissue gripper TGI. The posterior leaflet PL is captured in a similar manner between the second paddle P2 and a second tissue gripper TG2. Independent leaflet capture is achieved by selectively operating the first paddle PI and the first tissue gripper TGI to engage the first (e.g., anterior) leaflet, or the second paddle PI and the second tissue gripper TG2 to engage the second (e.g., posterior) leaflet, as in the current PASCAL and the latest generation of MitraClip TM The captured leaflets can be held between the tissue grippers TGI, TG2 and the respective cooperating paddles PI, P2 even as the illustrated paddles are in an open position relative to the opposing paddle, or the paddles are spaced apart by the spacer SP. As shown, the paddles PI, P2 of the clip are shown in a fully closed position with the captured tissue of the anterior leaflet AL and the posterior leaflet PL in close spatial relationship. FIG. 42D

[0250] The mesh construction 371 of the clip connector 370 of the prosthetic valve 300 can be fabricated from multiple layers of fabric material (as shown) or in a laminate structure to enhance its structural strength. The spacer SP is configured with a slot of appropriate dimensions to engage the mesh construction 371 and secure the mesh construction 371 in a reliable manner and to withstand the dynamic loads imparted to the prosthetic valve 300 during the cardiac cycle. The clip CL can be designed such that the closure of the clip CL can impart an additional mesh-clamping load across the slot in the spacer SP. FIG. 42E A variation of the mesh construction 371 of the clip connector 370 coupled with the clip CL is shown. The clip CL is configured with a pair of barb members BM. The mesh construction 371 has sufficient thickness and structural integrity to be penetrated by a series of barbs BR of the barb members BM to allow the prosthetic valve 300 to be securely coupled to the clip CL. The structural rigidity and spacing of the barb members BM and the orientation of the barbs BR allow the mesh construction 371 to be inserted in one direction and prevented from retracting in the opposite direction. Alternatively, similar to the tissue TGI, TG2, the barb members BM can be moved and operated between an open position to receive the mesh construction 371 and a closed position in which the mesh construction 371 is secured. Such a closed position can coincide with the final closed position of the clip CL.

[0251] FIG. 42F ​Another variation is shown in which the mesh configuration 371 of the clip connector 370 is coupled between the spacer SP and the capturing leaflet (e.g., the anterior leaflet AL). The tissue holder TG1 has a second series of barbs BR configured on opposite sides of the barbs BR for capturing the anterior leaflet AL. The spacer SP is configured with a similar series of barbs. Inserting the mesh configuration 371 between the spacer SP barbs BR and the tissue holder TG1, and closing the clip CL, securely couples the artificial valve 300 to the clip CL. Insertion of the mesh configuration 371 is easily achieved by engaging the paddle PA and the tissue holder TG1 with the anterior leaflet AL, but selectively positioning the anterior leaflet AL in its open position separated from the spacer SP within the paddle P1.

[0252] The artificial valve 300 also includes a valve annulus connector 380 (for ease of explanation, FIG. 42A (Not shown in the image). In this embodiment, the valve annulus connector includes a first arm 381 and a second arm 383. The first arm 381 is an arcuate elongated rod or strut coupled to the inlet portion 312 of the body 310 and extending laterally downward, terminating at its distal end in a first valve annulus anchor 382. This first valve annulus anchor is a transversely arcuate elongated rod or strut, sized and oriented to engage the valve annulus of a natural valve, such as the mitral valve annulus MVA of the mitral valve MV. FIG. 42C As shown. (Note, FIG. 42B and 42C A slightly different implementation of the valve ring connector 380 is shown—in FIG. 42B In the middle, the first arm 381 and the second arm 383 are coupled to the entrance 312, while FIG. 42C In this configuration, the first arm 381 and the second arm 383 are coupled to the first lobe 316 and the second lobe 317. The second arm 383 is a mirror image of the first arm 381 and terminates at the second lobe annular anchor 384, which is a mirror image of the first lobe annular anchor 382. FIG. 42B In one embodiment, the annular connector 380 is configured to engage with the upper atrial side of the mitral valve annulus MVA, but... FIG. 42C In some embodiments, it is configured to alternatively engage with the inferior ventricular side of the mitral valve annulus MVA, or the artificial valve 300 may include two annulus connectors, one on each side of the annulus.

[0253] The artificial valve also includes a flow control device 360, which in this embodiment is a three-leaflet valve, disposed in the flow control passage 332 and coupled to the body frame 320 in the inlet portion 312 of the body 110. Blood flow through the artificial valve is shown by arrows, i.e. blood can flow from the left atrium LA into the inlet 331, into the flow control passage 332, through the flow control device 360, into the transition passage 333, into both the first leaflet passage 334 and the second leaflet passage 336, and out from the first outlet 335 and the second outlet 337 into the left ventricle LV. This blood flow will occur during the diastolic portion of the cardiac cycle. During the systolic portion, the flow control device 360 will prevent blood from flowing in the opposite direction from the left ventricle LV to the left atrium LA.

[0254] FIG. 43 An artificial valve according to another embodiment is shown in FIG. 4. FIG. 43 The artificial valve 400 in FIG. 4 is similar to the artificial valve 300 in FIG. 3 FIG. 42A to 42C The artificial valve 400 in FIG. 4 is similar to the artificial valve 300 in FIG. 3

[0255] The artificial valve 400 includes a body frame 420 that is formed with different structures in different portions. In the inlet portion 412, the transition portion 413, and portions of the first leaflet 416 and the second leaflet 417, the body frame 420 has a diamond honeycomb-shaped metal mesh construction, for example by using a laser-cut tube (commonly used for the stent or body of artificial valves). However, in the portions of the first leaflet 416 and the second leaflet 417 that are to be disposed in the flow control portion of the clamping valve and thus in contact with the edges of the native leaflets, the structure of the body 410 is less. In particular, the stent-like structure of the leaflets has gaps in the leaflet contact areas 416a of the first leaflet 416 and 417a of the second leaflet 417, and the gaps are spanned by a small number of wires (or elongated rods) 421d that connect the stent-like portions. The wires can be preferably arranged adjacent to the lateral inner and outer edges of the leaflets, so that when the artificial valve 400 is disposed in the mitral valve, the wires are adjacent to the clips and the commissures of the valve, i.e. away from the native leaflets, to minimize direct contact with the native leaflets. Additional wires or other support structures can be added as needed to maintain the shape of the leaflets in the leaflet contact areas. The outlet end of each leaflet can be formed with a structure different from the stent frame, for example a simple circular or elliptical wire.

[0256] The entire body frame 420 is covered with a body covering 422, which in this embodiment is made of pericardial tissue. The body covering 422 is secured to the frame-like portion of the body frame, i.e. above and below the leaflet contact area of the leaflets, but can not be attached to the underlying wire in the leaflet contact area. Thus, the engagement of the native leaflets with the body covering 422 in the leaflet contact area exerts less stress and wear on the tissue of the native leaflets, as the body covering is only supported by the blood in the first and second leaflet passages 434, 436.

[0257] FIG. 44 An artificial valve according to another embodiment is shown in FIG. FIG. 44 The artificial valve 500 in FIG. FIG. 42A to 42C The artificial valve 300 in FIG. - the following description focuses on the differences of interest and omits common details. The clips and annulus connectors are shown in dashed lines for reference. FIG. 44 An alternative method of maintaining the artificial valve 500 in proper spatial relationship with the flow control portion FCP is shown, i.e. maintaining the spatial relationship through the annulus connectors, without using the clip connectors. This embodiment has another variation in structure that can reduce wear on the native leaflets. While a typical stent-mounted artificial valve is completely or partially covered by a fabric such as Dacron, the artificial valve 500 includes a body covering 522 having two portions, i.e. a body covering inlet portion 522a and a body covering leaflet portion 522b, each formed of a different material. The body covering leaflet portion 522b of the body covering 522 for the portion of the body covering 522 that contacts the native leaflets during use is formed of pericardial or similar biological material. This biological material is more resistant to wearing on the native leaflets than the fabric material that covers the remainder of the artificial valve 500.

[0258] FIG. 45A to 45C An artificial valve according to another embodiment is shown in FIG. FIG. 45A to 45C The artificial valve 600 in FIG. FIG. 42A to 42C The artificial valve 300 in FIG. - the following description focuses on the differences of interest and omits common details. The clips and annulus connectors are shown in dashed lines for reference. This embodiment is used to illustrate a process that can be used to address leakage between the leaflets of the artificial valve and the native leaflets.

[0259] To effectively prevent mitral regurgitation, the native valve leaflets should sealingly engage the leaflets of the prosthetic valve. It is known that as heart failure causes the heart to deteriorate, the native valve leaflets can become more dispersed and regurgitation can increase. It is contemplated that the native valve leaflets can be stretched large enough that the native valve leaflets no longer sealingly engage the leaflets of the prosthetic valve. This potential problem can be addressed by a procedure in which one or more of the first leaflet 616 and the second leaflet 617 can be expanded to a larger perimeter after the prosthetic valve 600 has been delivered. Such a procedure can be performed together with the procedure in which the prosthetic valve 600 is delivered and deployed, for example by assessing the sealing of the native valve leaflets against the first leaflet 616 and the second leaflet 617, for example by measuring the presence and severity of regurgitation, and using the procedure to address any such regurgitation. Alternatively, the procedure can be performed separately, for example after an initial procedure has been performed to deliver and deploy the prosthetic valve 600 and deterioration of the heart causes the onset or increase in regurgitation.

[0260] The procedure to reshape or increase the perimeter of the first leaflet 616 and / or the second leaflet 617 can be accomplished in a number of ways. First, as shown in FIG. 6A, a catheter C having an inflatable balloon B (with a balloon-inflatable stent ST disposed thereon, for example made of stainless steel or cobalt-chromium) can be delivered to the native valve and into the second leaflet passage 636 of the second leaflet 617 (via the flow control passage 632, the flow control device 660 and the transition passage 633). The balloon B can then be inflated, causing the stent ST to expand, engage the second leaflet portion of the main body frame 620, and then expand. The final state of the prosthetic valve 600 is shown in FIG. 6B, where the stent ST is in place in the second leaflet 617. If the dashed line in FIG. 6A shows the original size of the second leaflet 617, the arrow indicates the expansion of the stent ST, and the solid line shows the expanded size of the new second leaflet 617. FIG. 45B FIG. 45C FIG. 45C

[0261] Another method of expanding, for example, the perimeter of the second leaflet 617 is to use a self-expanding stent ST (for example, a stent formed of a shape memory material such as Nitinol) and deliver it to the second leaflet 617 with a catheter (not shown) having a delivery lumen from which the stent ST can be sent into place. It is known that one benefit of using a self-expanding stent is that such a stent can be retrieved (for example, through the delivery catheter before deployment is complete, or through a retrieval catheter if it has already been deployed) if the delivery is unsatisfactory or the stent fails.

[0262] Expanding, for example, the second leaflet 617 (which can result in FIG. 45C ​​​A third approach to the periphery of the second flap 618 (as shown in the diagram) is to omit the stent ST and directly use the balloon B on the catheter C to further expand the periphery of the portion of the main frame 620 in the second flap 618 from the initially delivered and expanded periphery, for example, if this portion of the main frame 120 is made of an expandable material such as stainless steel or cobalt chromium (instead of a shape memory material).

[0263] According to another embodiment, the artificial valve is as follows: FIG. 46A to 46C As shown. FIG. 46A to 46C The artificial valve 700 is similar to FIG. 42A to 42C The artificial valve 300 in this embodiment—the following description focuses on the differences of interest and omits common details. This embodiment is used to illustrate that the artificial valve 700 can have a relatively short axial height (particularly in the left atrium) and a relatively large inlet diameter flow control channel.

[0264] The artificial valve 700 has a body 710, which has an inlet 712, a transition 713, and an outlet 714 (with a first flap 716 and a second flap 717). The body 710 defines a flow channel including a flow control channel 732, a transition channel 733, a first flap channel 734, and a second flap channel 736, and extends between an inlet 731 and a first outlet 735 and a second outlet 737. A flow control device 760 is disposed in the flow control channel 732. FIG. 46B and 46C As shown, the flow control device 760 has a relatively short axial height (i.e., along its central longitudinal axis). The entire body also has a relatively short axial height between the inlet 731 and the first outlet 735 and the second outlet 735. Therefore, when the artificial valve 700 is placed in a natural valve, such as the mitral valve between the left atrium (LA) and the left ventricle (LV), as... FIG. 46B As shown, inlet 731 is located in the left atrium LA, but with sufficient clearance from the atrial wall to allow good blood flow into the flow control device 750. First outlet 735 and second outlet 737 are located in the left ventricle LV, but do not extend too far into the ventricle, thereby minimizing contact with parts of the natural valve assembly or the ventricular wall. FIG. 46A to FIG. 46C As shown, the flow control device 760 also has a larger diameter relative to the overall size of the artificial valve 700, as do the first outlet 735 and the second outlet 737 (and the flow passage between the inlet 731 and the outlet), thus providing a large flow area for blood to travel from the left atrium LA through the artificial valve 700 to the left ventricle LV during diastole. FIG. 46B and 46C As shown by the arrow in the image.

[0265] Similar to the prosthetic valve 300, the prosthetic valve 700 includes a clip connector 770, which is composed of a structured mesh formation 771 extending from and straddling the first leaflet 716 and the second leaflet 717 of the valve 700. The clip connector 770 can be coupled to the clip CL in various ways as previously described in FIG. 42D to 42F FIG. 1. Once coupled to the clip CL, the mesh formation 771 of the clip connector 770 is engaged between opposing paddles or clip members of the clip CL, and can also be engaged between captured portions of opposing and proximate native valve leaflets (e.g., the anterior leaflet AL and the posterior leaflet PL in the mitral valve MV).

[0266] A prosthetic valve according to another embodiment is shown in FIG. 47A to 47D FIG. 2. Figures 47A-47D The prosthetic valve 800 in Figures 46A-46C FIG. 2 is similar to the prosthetic valve 700 in FIG. 1 - the following description focuses on the differences of interest and omits common details. This embodiment is used to illustrate the structure used to couple the prosthetic valve 800 to the clip CL.

[0267] The prosthetic valve 800 has a clip connector 870 that transmits the fluid dynamic loads exerted on the prosthetic valve 800 to the clip CL through an axial clip post 873. The axial clip post is in turn connected to the body frame 820 via two paths: via three radial valve struts 872 coupled between the axial clip post 873 and an upper edge of the frame of the flow control device 860 (which can be coupled to the body frame 820 or a portion of the body frame 820), and via a U-shaped undercrotch strut 874 coupled between the axial clip post 873 and a portion of the body frame 820 between the first leaflet 816 and the second leaflet 817. The body frame 820 includes an outlet portion 825 (which can be a short segment of a stent structure) at the outlet ends of the first leaflet 816 and the second leaflet 817 to keep the first outlet 835 and the second outlet 837 open. The undercrotch strut 874 can be coupled to the outlet portion 825. The axial clip post 873 is coupled to the clip CL via any suitable mechanical joint (e.g., tongue-and-groove, barb fitting, snap fit, etc.). In this way, the prosthetic valve 800 can be coupled to the clip CL: i) after the clip CL has been pre- and fully deployed (i.e., both valve leaflets of the target native valve have been captured by the clip CL); ii) after the clip CL has been partially deployed and only one native valve leaflet is captured between the central spacer and the second clip member (e.g., between the spacer SP and the paddle PI of the clip CL as shown), and iii) after the clip CL has been partially deployed and both native valve leaflets are captured between the central spacer and the first clip member (e.g., between the spacer SP and the paddle P2 of the clip CL as shown). Figures 42D-42F Figures 42D-42F ​before capturing the native leaflets; or iii) before capturing the leaflets by the clip CL (i.e., the prosthetic valve 800 and the clip CL form a device assembly prior to delivery to the target heart valve of the patient). A releasable mechanical joint can also be used, allowing the prosthetic valve 800 to be separated from the clip CL and replaced with a prosthetic valve of different size or configuration if surgical intervention requires such a replacement.

[0268] The radial valve struts 872 are configured and arranged to be disposed below the line of coaptation of the leaflets 862 of the flow control device 860, as best shown in Figure 47A Fig. 47A (the leaflets 862 are shown open during diastole) and 47B (the leaflets 862 are shown coapted during systole, the radial valve struts 872 are shown in dashed lines). In Figure 48 In the alternative embodiment shown, the prosthetic valve 900 includes radial valve struts 972 configured and arranged to be disposed above the line of coaptation of the leaflets 962 of the flow control device 960. In both embodiments, the radial valve struts 872 and 972 can be firmly coupled to the frame of the flow control device and do not interfere with the operation of the flow control device leaflets - thus, these designs facilitate the use of prosthetic valves already developed for use in flow control devices without the need to redesign them.

[0269] In Figure 47C and 47D the prosthetic valve 800 is shown placed in the native mitral valve MV in a delivery position, in end view and exploded view, respectively. Figure 47D The clip CL is shown with its paddles PI, P2 open and with a clear view of the native leaflets AL and PL and the relationship of the clip connector 870 to the clip CL. The spacer SP is of suitable size and volume to advantageously allow the configuration of a mechanical joint or other suitable interface to properly engage the clip connector 870 of the prosthetic valve 800. The latter can be achieved by one or both of the paddles PI, P2 being in their open and spaced apart position, or by the paddles PI and P2 being in the closed position and close to the spacer SP.

[0270] A prosthetic valve according to another embodiment is shown in Figures 49A-49B . Figure 49A The prosthetic valve 1000 in 49B is similar to the prosthetic valve 300 in Figures 42A-42C - the following description focuses on the differences of interest and omits common details. This embodiment illustrates an alternative design of the annulus connector.

[0271] As Figure 49A and 49BThe prosthetic valve 1000 is shown in a deployed configuration. The prosthetic valve 1000 includes a main frame 1020 that is integrated with a clip connector 1070 and an annulus connector 1080. The main frame 1020 is coupled to a flow control device 1060. The flow control device 1060 is coupled to a main body 1010 that is coupled to a lower leg strut 1074. The main body 1010 is coupled to a main body frame 1020 that is coupled to a first annulus anchor 1082 and a second annulus anchor 1084. Figures 47A-47D Unlike the clip connector 870 of the prosthetic valve 800 in FIG. 8, the load path of the clip connector 1070 is only through the lower leg strut 1074. The exit portions 1025 of the main frame 1020 are wire hoops or loops, and each exit portion is coupled at its lateral inside to a lower end of the lower leg strut 1074 and at its lateral outside to a main frame lateral strut 1026 that extends axially along a lateral outside of the main body 1010. Each main frame lateral strut 1026 is coupled at its upper end to a frame of the flow control device 1060 and / or the annulus connector 1080.

[0272] The annulus connector 1080 includes a first arm 1081 and a second arm 1083, each extending from the frame of the flow control device 1060 and / or an upper end of a respective main frame lateral strut 1026, and having a first annulus anchor 1082 and a second annulus anchor 1084, respectively, at a distal end thereof. In this embodiment, the annulus connector 1080 engages the atrial side of the mitral valve annulus MVA. However, alternatively or additionally, the annulus connector can include arms that extend through the mitral valve commissure and have annulus anchors disposed to engage the ventricular side of the mitral valve annulus MVA. The first annulus anchor 1082 and / or the second annulus anchor 1084 can include tissue-piercing members, such as barbs, for enhanced fixation to heart tissue.

[0273] Figure 50 A prosthetic valve according to another embodiment is shown. Figure 50 The prosthetic valve 1100 in FIG. 11 is similar to the prosthetic valve 1000 in FIG. 10, Figure 49A and 49B The prosthetic valve 1000 in FIG. 10, but includes an annulus connector 1180 that engages both the atrial side and the ventricular side of the mitral valve annulus MVA.

[0274] As Figure 50As shown, the prosthetic valve 1100 includes a main body frame that includes outlet portions 1125, each of which is coupled at its lateral inner side to a lower end of a lower crotch strut 1174 and at its lateral outer side to a main body frame lateral strut 1126 that extends axially along the lateral outer side of the main body 1110. Each main body frame lateral strut 1126 is coupled at its upper end to a frame of the flow control device 1160. The annulus connector 1180 includes two first annulus anchors 1182 and two second annulus anchors 1184 that extend from respective main body frame lateral struts 1126. One first annulus anchor 1182 engages the atrial side of the mitral valve annulus MVA, while the other first annulus anchor 1182 engages the ventricular side of the mitral valve annulus MVA. Similarly, one of the second annulus anchors 1184 engages the atrial side of the mitral valve annulus MVA, while the other of the second annulus anchors 1184 engages the ventricular side of the mitral valve annulus MVA.

[0275] The clip connector 1170 includes a transverse strut 1175 that is coupled at its ends to the two main body frame outlet portions 1125 and at its center to the clip CL. Unlike some of the previous embodiments, the transverse strut 1176 can be disposed on the ventricular side of the clip CL and even below the level of the native valve leaflet free edge that is captured within the clip CL.

[0276] Figure 51A And 51B A prosthetic valve according to another embodiment is shown in top view and in partial cross-sectional end view. The prosthetic valve 1200 includes a non-standard flow control device 1260 that can provide better blood flow through the prosthetic valve 1200. The flow control device 1260 can be used with any of the prosthetic valve embodiments described above, such as the prosthetic valves 300, 400, 500, 600, 700, 800, 900, 1000, and 1100, instead of the standard three-leaflet design.

[0277] As Figure 51A And 51B shown, and in Figure 51C And 51DIn more detail, as shown in perspective view, the flow control device 1260 includes a stent frame 1261 supporting two regular leaflets 1262, each of which subtends one third of the circumference of the flow control device 1260. However, rather than being adjacent to each other and connected at the commissure, the leaflets 1262 are spaced apart from each other, diametrically opposed to each other, and aligned with the first and second leaflet segments 1216 and 1217, and correspondingly with the first and second leaflet passages 1234 and 1236. Rather than being coapted to each other, the leaflets 1262 are coapted to static half-cusps 1265, each of which subtends one sixth of the circumference of the flow control device 1260 and is disposed between the leaflets 1262. The flow control device 1260 is shown in Figure 51C the configuration it assumes during systole, i.e. with the tissue leaflets 1262 coapted to the static half-cusps 1265. Figure 51D The flow control device 1260 is shown in

[0278] As shown in more detail in Figures 51D-51F each static half-cusp 1265 includes a static cusp frame 1266 and a static cusp membrane 1267 supported on the static cusp frame 1266. Both the leaflets 1262 and the static cusp membranes 1267 can be formed from tissue such as pericardium. The static cusp frame 1266 can be formed from the same material as the main frame of the flow control device 1260, e.g. stainless steel, cobalt-chrome or nitinol. As shown in Figure 51B and Figures 51D-51F the static cusp frame 1266 can be coupled to the axial clip post 1273 of the clip connector 1270. Variations in the construction of the static half-cusp assembly are possible, including covering or encapsulating the frame 1266 with a suitable biopolymer membrane, e.g. a silicone poly(polyurethane-urea) formulation. Alternatively, the volume defined by the static cusp frame 1266, the static cusp membrane 1267 and the stent frame 1261 can comprise a collapsible open-cell foam polycarbonate urethane covered with pericardium or a biopolymer membrane. Alternatively, the static half-cusps can be constructed to include a biopolymer, biocompatible or bioengineered material that is capable of maintaining its shape and geometry in use, and is suitable for resisting calcification, bearing the stresses and strains of the cardiac cycle, and is non-thrombogenic. Such a material is also suitable for the moveable cusp in the prosthetic valves 300, 400, 500, 600, 700, 800, 900, 1000 and 1100, rather than the more commonly used animal pericardium. One example of a prosthetic valve using such a biopolymer material is the Tria Valve produced by Foldax, Inc.

[0279] In operation of the flow control device 1260, during diastole, the leaflets 1262 open, collapsing against the periphery of the flow control device, i.e. as shown inFigure 51A Blood can flow from the left atrium LA into the inlet 1231, through the aperture between the leaflet 1262 and the static half cusp 1265, and into the first and second petal passages 1234, 1236. As shown, the alignment of the leaflet 1262 with the petal passages provides a smooth, relatively straight flow path. During systole, the leaflet 1262 coapts with the static cusp 1267 and seals against retrograde blood flow or regurgitation, similar to the coaptation of leaflets in a tricuspid valve. In the configuration of the prosthetic valve 1200 shown with petal passages 1234, 1236 that are not diametrically opposed, the alignment of the leaflet 1262 can be tailored to align with the petal passages by varying the amount of the circumference of each static half cusp 1265 that faces the flow control device 1260. For example, in an embodiment with a first petal 1216 and a second petal 1217 oriented at 160 degrees relative to the clip CL, one static half cusp 1265 can be configured to face one- ninth of the circumference, and the other static half cusp 1265 can be configured to face two-ninths of the circumference, such that the leaflet 1262 ultimately aligns with the petal passages 1234, 1236. Figure 51A Figure 51A

[0280] The prosthetic valve embodiments described above include a single flow control device to control flow through the (two or more) flow control portions of the clamped native valve by combining bifurcated flow control passages with two (or more) petal passages extending through two petal(s), each petal passage preferably sealingly engaging a native valve leaflet in a respective flow control portion. In the following prosthetic valve embodiments, separate flow control devices are used to control flow through each flow control portion of the clamped native valve. Thus, for a clamped native valve having two flow control portions for which it is desirable to control flow through both flow control portions using a prosthetic valve (rather than relying solely on the functionality of the clamped native valve leaflets forming the flow control portions), the prosthetic valve includes two flow control devices. For a clamped native valve having a single flow control portion or having multiple flow control portions for which it is desired or expected that regurgitation be addressed through only one of the flow control portions, the prosthetic valve includes a single flow control device. Other structures and functionality described above with respect to the prosthetic valve embodiments also apply to the embodiments described below, and the embodiments described below include additional structures or functionality, as will be clear from the following description. In general, for ease of reference, the same reference numbering scheme is used for the preceding and following embodiments, and any structures in the following embodiments that correspond to structures of the preceding embodiments can include all the same details of design and implementation, as well as all the same options and alternatives as described above, unless otherwise apparent from the following detailed description.

[0281] In Figure 52A and 52B ​​An embodiment of a prosthetic valve 2000 is schematically illustrated in side view and top view. The prosthetic valve 2000 includes a main body 2010 having an inlet portion 2012 and a first outlet portion 2014. The main body 2010 defines a flow passage 2030 therethrough, including a flow control passage 2032 in the inlet portion 2012 and an outlet passage 2034 in the first outlet portion 2014.

[0282] The various portions of the flow passage 2030 are in fluid communication with one another and can direct fluid (e.g., blood) from the inlet 2031 at the inlet portion 2012 through the flow control passage 2032 and through the outlet passage 2034 out of the outlet 2035 at the lower end of the main body 2010.

[0283] Flow through the flow passage 2030, and in particular through the flow control passage 2032, is controlled by a first flow control device 2060. The first flow control device 2060 can be similar in structure and function to any of the flow control devices described above for other embodiments. As Figures 52A-53B As schematically illustrated in the middle, the first flow control device 2060 can be cylindrical, having a circular cross-section. The first flow control device 2060 can be mounted to the inlet portion 2012 of the main body 2010 and disposed such that all flow through the flow control passage 2032 must pass through the first flow control device 2060. The first flow control device 2060 is configured to allow fluid to flow in the direction from the inlet 2031 to the outlet 2035 and to prevent fluid from flowing in the opposite direction.

[0284] As is known, tissue valves can fail, and it is also known that this problem can be addressed by delivering another tissue-based stent valve within the failed valve. Thus, it is contemplated that if the first flow control device 2060 fails, a new tricuspid valve can be placed within the first flow control device 2060.

[0285] The prosthetic valve 2000 also includes a clip connector 2070 that is part of or coupled to the main body 2010 and configured to engage with the clip described above, thereby maintaining the prosthetic valve 2000 in operative relationship with the native heart valve to which the clip is attached. In particular, the clip connector 2070 is configured to transfer the fluid dynamic loads applied to the prosthetic valve 2000 during the cardiac cycle to the clip CL, and thereby to the native leaflets, annulus, and surrounding heart tissue, to resist displacement of the prosthetic valve. The maximum load to be carried tends to be during systole, while the displacement to be resisted is toward the atrium of the heart.

[0286] The clip connector can be implemented in a variety of configurations, including the above-described configuration, as well as other variations described in more detail below. As noted above, the clip CL can be any commercially available design, or can be customized or modified to be specific to the prosthetic valve 2000. For example, as described in more detail below with respect to particular embodiments, the clip CL can have a spacer disposed between the paddles of the clip (similar to the spacer of the PASCAL clip), and the spacer can be configured to fill or occlude a portion of the space between the native leaflets of the clamped native valve during the clamping process, thereby reducing the size of or filling a portion of the native valve orifice area. The spacer can be configured and dimensioned to increase the resulting flow control portion (e.g., adjacent the commissure between the native leaflets) relative to clamping the same native valve with a clip that does not have a spacer, and whereby the paddles are disposed closer to one another.

[0287] As Figures 52A-53B illustrated schematically, the prosthetic valve 2000 can include a second body 2010' and an associated second flow control device 2060', which can also be connected to the clip connector 2070, and which can also have an optional annulus connector 2080' (or be connected to the same annulus connector 2080). The body 2010' can be identical in structure and function to the body 2010, including having a flow passage 2030' with an inlet 2031', a flow control passage 2032', an outlet passage 2034', and an outlet 2035'. The body 2010' can have a body frame 2020', etc. The prosthetic valve 2000 with bodies 2010 and 2010' can be used to control blood flow in a clamped native valve that has two flow control portions in which regurgitation is desired to be reduced - the body 2010 can be disposed in a first flow control portion FCP1, and the body 2010' can be disposed in a second flow control portion FCP2, as Figure 53A and 53B illustrated.

[0288] In Figure 53A and 53B , the prosthetic valve 2000 is shown disposed in a native heart valve, in side view and top view, respectively. Note that the native heart valve is shown as a mitral valve MV for ease of illustration. Also note that the prosthetic valve 2000 is shown with an optional second body 2010' disposed in one of the two flow control portions of the clamped mitral valve MV. The mitral valve MV is shown as being connected by the clip CL with the anterior leaflet AL and the posterior leaflet PL in an edge-to-edge approximation, similar to the mitral valve MV shown in Figure 37B . Thus, the mitral valve MV has two flow control portions FCP1 and FCP2 defined between the clip, the leaflets, and the commissures of the mitral valve MV. As noted above with respect to Figures 37A-38FAs discussed, there are many possible clip arrangements on the mitral or tricuspid valve: creating one, two, or three flow control sections—the artificial valve 2000 can be used with any of these clipped valve configurations to address regurgitation in one or two of the flow control sections.

[0289] like Figure 53A and 53B As shown, the artificial valve 2000 can be disposed in the mitral valve MV, with inlets 2031 and 2031' disposed in the left atrium LA, and outlets 2035 and 2035' disposed in the left ventricle LV. Body 2010 is shown disposed in the flow control unit FCP1, and body 2010' is shown disposed in the flow control unit FCP2. Clip connector 2070 engages with clip CL. Optional annular connectors 2080 and 2080' can engage with the mitral valve annulus MVA. Similarly, an optional cardiac tissue tether 2090 can engage with cardiac tissue, for example, in the left ventricle LV. When the artificial valve 2000 is disposed in the mitral valve MV, it is operable to reduce or eliminate backflow through the flow control units FCP1 and / or FCP2, i.e., to prevent blood from flowing backward from the left ventricle to the left atrium during systole, but to allow blood to flow freely through the artificial valve 2000 from the left atrium LA to the left ventricle LV during diastole.

[0290] The height of the entrance 2012 of the main body 2000 can be any suitable distance, but it is best not to be so large that it would obstruct the flow of blood into the entrance 2031. That is, there should be enough space above and around the entrance 2031 in the atrium of the heart so that blood can enter freely.

[0291] Each of the main bodies 2010 and 2010' can be configured such that its outer surface engages the anterior and posterior leaflets AL, PL in substantially sealed relation, thereby reducing or preventing blood flow therebetween during at least a portion of the heart pumping cycle. In some embodiments, each of the first and second main bodies 2010, 2010' is sized (e.g., circumference) and configured (e.g., cross-sectional shape is circular, elliptical, ovoid, etc.) to substantially fill or overfill (stretch) the respective flow control portion, maintaining the leaflet edges in sealed relation with the outer surface of the first and second main bodies 2010, 2010' throughout the cardiac cycle, thereby preventing flow between the outlet portion and the leaflets from the atrium to the ventricle during diastole and from the ventricle to the atrium during systole. In this configuration, therefore, substantially all blood flow from the atrium to the ventricle during diastole passes through the prosthetic valve (and thus through the first and second flow control devices 2060, 2060') and blood flow from the ventricle to the atrium during systole (regurgitation) is substantially prevented (by the first and second flow control devices 2060, 2060'). This configuration provides several benefits. First, the native leaflets move little or not at all during the cardiac cycle, which reduces wear from repeated contact between the leaflets and the outer surface of the prosthetic valve main body (there is little momentum on the native leaflets during impact with the outlet portion). The native leaflets are pliable and tend to fill any irregular shape or closure defect. Second, it is important to ensure that the valve is completely sealed, i.e., prevents regurgitation. Finally, in patients requiring valve repair or replacement, the heart tends to deteriorate over time. For such patients, regurgitation should not occur again because the prosthetic valve is effectively fully responsible for the function of the native valve and the residual valve tissue will be able to fill any gaps that can occur as the heart dilates (or alternatively, any gaps that can occur as the valve leaflets contract as the disease progresses). These benefits are particularly applicable to native valves that have had an edge-to-edge clip applied. After the clip is applied, the total opening size of the valve is limited to the area of the resulting flow control portion, which is smaller than the area of the original opening of the native valve. Thus, the surface or orifice area occluded by the valve must be reduced, as well as the load on the prosthetic valve. In many cases, the clip can firmly hold the load created by the contraction of the heart, which is highest during systole.

[0292] In another configuration, the main bodies 2010, 2010' can be sized smaller than the flow control portion, thereby allowing a gap to form during diastole and allowing some blood flow from the atrium to the ventricle through the gap (in addition to the blood flowing through the flow passage and the flow control device). The main bodies 2010, 2010' are preferably sized such that the leaflets can sealingly engage the outer surface of the main bodies during systole and prevent regurgitation between the leaflets and the main bodies.

[0293] The bodies 2010, 2010' of the prosthetic valve 2000 are schematically shown in Figure 52B and 53B as circular cross-sections, while the flow control portion of the native valve resulting from the leaflet clipping can be elliptical or slit-like, see Figure 53B for a convenient illustration. However, shaping the bodies with a corresponding cross-section can better follow the shape of the flow control portion and fill the leakage space. In some embodiments, at least in the leaflet contact area, the cross-sectional shape of the bodies can be more elliptical, or have a tear-drop (more V-shaped) shape, with the narrower portion oriented towards the commissure. Although the bodies are schematically shown in Figure 52B and 53B as being approximately linear in shape, or arranged symmetrically around a centerline through the clip, as shown in Figure 36A , the coaptation line of the native mitral valve leaflets has a natural curvature. When looking down on the mitral valve over the anterior leaflet, there is an upward curve to the closed line. To conform to this anatomical structure, in some embodiments the bodies of the prosthetic valve can be arranged to follow the curve of the coaptation line (i.e., the curve formed by the free edges of the opposing mitral or tricuspid valve leaflets during contraction).

[0294] The bodies 2010, 2010' are schematically shown in Figure 52B and 53B as being straight and parallel to each other. However, in some embodiments having two bodies, the bodies can be straight but can be non-parallel, and can be angled towards or away from each other. In other embodiments, they can not be straight, but can be arcuate.

[0295] Figures 52A-53B The bodies 2010, 2010' are schematically shown in

[0296] While the bodies 2010, 2010' are schematically shown in Figure 52B and 53BThe body 2010, 2010' is shown schematically as having flat ends (i.e., at the outlets 2035, 2035'), i.e., it is linear and orthogonal to the central vertical axis of the prosthetic valve 2000, but in other embodiments the ends of the body 2010, 2010' can be any other configuration, including angled and / or arcuate, so long as they can be reliably positioned in the native valve so that preferably the entire outlet is below the location where the native leaflets are in sealing engagement with the body 2010, 2010'. The outlet can also have a non-planar outflow perimeter, but rather a scalloped perimeter. For example, the outflow perimeter portion that engages the anterior leaflet AL can extend deeper within the ventricle than the corresponding portion that engages the posterior leaflet PL. In this way, the upward surge of blood during systole will first contact the more deeply extending portion of the outlet, and can ensure better systolic filling of the prosthetic valve 2000.

[0297] Each of the bodies 2010, 2010' can be constructed in a similar manner to known prosthetic heart valves, as described above. In the following description, for simplicity only the body 2010 is described, but all of the discussion applies equally to the body 2010'. The body 2010 can have a body frame 2020 formed of wire, struts, mesh construction, braided tape or other suitable structure made of metal (e.g., cobalt-chrome, stainless steel, shape memory metal such as nitinol, etc.), polymer or other suitable material. The body frame 2020 can be formed as a single integral piece, or it can be constructed of separate pieces that are connected together, e.g., one piece for each inlet portion 2012 and a separate piece for the first outlet portion 2014. In embodiments where the body frame 2020 is formed as separate pieces, the pieces can be delivered and implanted separately to make delivery easier, and then coupled together in place in the heart valve. As described in more detail below with reference to specific embodiments, the body frame 2020 need not extend to the first outlet portion 2014 of the body 2010. For example, a rigid graft (e.g., dacron with or without coating, Teflon, etc.) can be used without a frame or with a minimal frame.

[0298] The body 2010 and the body 2010' can differ in structure. In some embodiments, the portion of the body frame 2020 within the first outlet portion 2014 can be configured with a stent frame, and the body covering 2022 and / or the body liner 2023 can include or add a padding (formed of materials such as silicone and pericardium). It can be useful to make the first outlet portion 2014 more compliant, so that the outlet portion moves with each heartbeat and reduces wear on the leaflet tissue engagement devices. Thus, the first outlet portion 2014 can be constructed similar to the arrangements described above for prosthetic valves, e.g., Figure 5D 、 7A- the embodiments shown in B, 15A-E, or 18A-B. In such embodiments, the outlet portion can be configured with a frame that allows the overlying biocompatible covering (e.g., pericardium) to move anteriorly and posteriorly with each cardiac cycle. In other embodiments, the first outlet portion 2014 can be configured similar to Figure 13A - B and Figure 25A - the occlusion device shown in B, where the occlusion device is rigid or static and the native leaflets move toward the leaflet to seal, in turn, preventing leakage and abrasion.

[0299] In some embodiments, the first outlet portion 2014 of the prosthetic valve 2000 can be configured such that its shape is adjustable to improve the seal between the outlet portion and the native leaflets. For example, after the prosthetic valve 2000 has been placed in the native valve, an elliptical balloon or an elliptical stent can be introduced to shape the leaflets of the body portion. This approach can also be useful if the body covering 2022 and / or the body liner 2023 on (or in) the first outlet portion 2014 wears out. A new body liner 2023 can be applied from the inside of the first outlet portion 2014, delivered through the flow passage 2030 onto the stent or frame. This approach will be particularly useful if the first outlet portion 2014 is configured to have segments with little or no frame material.

[0300] The first flow control device 2060 is coupled to and supported by the body frame 2020 in the inlet portion 2012, or can optionally form part or all of the inlet portion of the body frame 2020.

[0301] The body frame 2020 can be covered externally with a body covering 2022, and / or internally with a body liner 2023, each of which can be formed of any suitable material that is biocompatible, sufficiently impermeable to fluid (e.g., blood) to form and maintain the flow passage 2030 within (or outside of) it, and to allow the body 2020 to be atraumatically contact the native valve tissue (leaflet, chordae, heart chamber wall, etc.). Suitable materials can include animal pericardium and synthetic materials, such as dacron (the latter material can be more suitable for covering areas of the body 2020 that do not contact heart tissue as it can be somewhat abrasive).

[0302] The main body covering 2022 and / or the main body liner 2023 may cover or line the entire main body 2020, or they may be discontinuous and only cover a portion of the main body 2020. Each may also be continuously attached to each area covered or lined by the main body frame 2020, but may also be attached around the periphery or edge of selected areas on the main body 2020, but not within those areas. This configuration allows blood to pass between, for example, the struts in the main body frame 2020, and causes the main body covering 2022 and / or the main body liner 2023 to expand / inflate, so that it gently contacts the natural valve leaflets. The natural valve leaflets will contact the material of the main body covering 2022 and / or the main body liner 2023 (e.g., the pericardium), which is supported by blood within the flow channel 2030. The main body frame 2020 may be formed with struts widely spaced in the contact area to ensure that the main body covering 2022 and / or the main body liner 2023 will be expanded by blood. This can significantly reduce wear on the natural valve leaflet tissue.

[0303] like Figure 52A and Figure 53A As shown, the body 2010 may also include an outlet flange 2024 at the outflow end of the first outlet portion 2014, which includes a padding material to reduce the risk of injury to cardiac tissue that may come into contact with those parts of the body during the cardiac cycle. This padding material can be any useful biocompatible material. Silicone, polyurethane, biopolymers or bioelastomers, polyester, and PTFE (Teflon) fabrics (often used in rolled or folded forms for the suture edges of artificial valve suture loops) are suitable choices commonly used in valve structures. This padding or damage-reducing material can be added to any part of the artificial valve 2000.

[0304] Although the clip CL can be a commercially available edge-to-edge leaflet clip, such as the MitraClip TM Or PASCAL, and the artificial valve 2000 is configured to engage with this clip after it has been used to clamp the natural leaflet; in some embodiments, the clip CL can be configured differently from this commercially available clip (e.g., see above reference). Figures 42D-42F Any clips described herein, and / or may be included as part of a system having an artificial valve device 2000, and configured to be delivered sequentially or simultaneously with the artificial valve 2000 as part of the overall valve repair / replacement procedure. As described above, the artificial valve 2000 is configured to be anchored to a clip CL, which is then coupled to the tissue of the anterior leaflet AL and the posterior leaflet PL, and the artificial valve 2000 will bear a considerable hydrodynamic load during systole, which must be borne by the clip and the leaflet. Therefore, an enlarged clip anchor may be useful. For example, the clip may consist of two or three blades (instead of PASCAL and MitraClip). TMThe device's individual blades are used to increase the area of ​​the leaflets engaged by the clamps. This allows dynamic loads to be distributed more evenly over a larger leaflet area (and over a greater number of lower chordae tendineae attached to the engaged leaflet portions).

[0305] In some embodiments, these loads can be partially borne by other structures without requiring clips or natural leaflets to be placed in the load path, rather than relying on clip connectors (and thus clips, natural leaflets, or other natural valve tissue) to bear all the fluid dynamic loads applied to the artificial valve. Therefore, in some embodiments, the artificial valve may include an optional annular connector 2080 and / or an optional cardiac tissue tether 2090.

[0306] like Figures 52A-53B As shown, the optional annular connector 2080 may be part of or coupled to the body 2010 and configured to engage with the annulus of the natural heart valve (and / or other nearby tissues, including the atrial wall, natural leaflets, and / or chordae tendineae) to enhance the stability of the artificial valve 2000 when placed in the natural heart valve, for example, by suppressing lateral rocking of the artificial valve relative to the plane of the natural valve and / or displacement away from the annulus toward the atrium (during systole) or ventricle (during diastole). The annular connector 2080 may be implemented similarly to the annular connector described above with reference to various embodiments of selective occlusion devices and artificial valves. The annular connector 2080 may be configured with a non-tissue-penetrating member or a tissue-penetrating member. The optional body 2010' may also have the annular connector 2080', or may share the same annular connector 2082 with the body 2010.

[0307] like Figures 52A-53B As shown, one or more optional cardiac tissue tethers 2090 can be coupled to the body 2010, 2010', clip connector 2070, clip CL and / or valve annulus connectors 2080, 2080'. For ease of illustration, not all options are shown in all figures. The cardiac tissue tether 2090 and its cardiac tissue anchor 2092 can be implemented in the same manner as the cardiac tissue tether 190 and cardiac tissue anchor 192 described above for the artificial valve 100 and other embodiments.

[0308] The artificial valve 2000 can be delivered to and positioned within the natural valve via various methods and sequences, and secured to the clip CL via a clip connector, to the valve annulus (and / or nearby tissue) via an annulus connector, or to other cardiac tissue via a cardiac tissue tether. Delivery, positioning, and / or fixation can also be performed as part of an integrated procedure with a clip CL, sequentially after a margin-to-margin approximation procedure within the same interventional process, or as a standalone procedure for patients who have previously undergone margin-to-margin approximation. Reference Figure 54 The flowchart shown in the diagram illustrates method 2100 to describe several options. In step 2101, one or more clips CL may optionally be delivered to the natural valve and used to clamp the natural leaflet for edge-to-edge approximation. As described above, this procedure may create two flow control sections, each defined by the junction of the natural leaflet, / or clips, and the natural valve. As described above, 2101 may be performed in advance in a separate procedure or as part of the same procedure as a subsequent part of method 2100. In step 2102, leakage or regurgitation of the clamped natural valve may be assessed, and it may be determined whether any such leakage or regurgitation is severe enough to affect the use of the prosthetic valve 2000. In step 2103, the extent of leakage or regurgitation, the size of the flow control section, and / or other relevant clinical information (e.g., by imaging) may be determined to enable the selection of an appropriate prosthetic valve (e.g., the size of the first outlet 2014 and the second outlet 2014′). In step 2104, the artificial valve 2000 is delivered to the natural valve, for example, using a delivery catheter via a known endovascular technique. In step 2105, the artificial valve 2000 is disposed in the natural valve, wherein the inlet 2031 of the flow channel 2030 is disposed in the atrium of the heart, wherein the first outlet 2014 of the body 2010 of the artificial valve 2000 is disposed in the first flow control unit FCP1, and the outlet 2035 of the outlet channel 2034 is disposed in the ventricle of the heart. Alternatively, for embodiments of the artificial valve 2000 including a second body 2010', the artificial valve 2000' may be configured such that the inlet 2031' of the flow channel 2030' is disposed in the atrium of the heart, and the outlet 2035' of the outlet channel 2034' is disposed in the ventricle of the heart. In step 2106, the clip connector 2170 is coupled to the clip CL, which is clamped to the natural valve leaflet. In integrated surgery, the clip connector 2170 can be coupled to the clip before the clip CL is clamped to the natural leaflet for edge-to-edge approximation.

[0309] Optionally, in step 2107, the valve annulus connector 2180 may engage with a natural valve annulus (on the ventricular side and / or atrial side) and / or adjacent tissue. Although in Figure 54In the flowchart, 2107 is shown after 2106, but in some embodiments, the annular connectors 2180, 2180' may first engage with the natural annular valve, i.e., the artificial valve is in place within the natural valve, and then the clip connector 2170 may be coupled to the clip CL. Also optionally, in step 2108, one or more cardiac tissue tethers 2190 may engage with cardiac tissue at one or more locations within the heart. Further optionally, at the completion of method 2100, or in a subsequent process, if some blood backflow is identified and determined to be due to insufficient sealing between the natural leaflets in the flow control portion of the natural valve and the first outlet portion 2014 and the second outlet portion 2014' of the bodies 2010, 2010', in step 2110, one or both of the first outlet portion 2014 and the second outlet portion 2014' may be further expanded or re-expanded to reshape or increase the periphery of the outlet portion and improve the seal with the natural leaflets, as described in more detail above.

[0310] According to another embodiment, the artificial valve is as follows: Figures 55A-55C As shown, it is positioned in the centrally held mitral valve MV. Figures 55A-55C The artificial valve 2200 includes two bodies 2210 and 2210′, which are shown to be disposed in the two flow control sections FCP1 and FCP2 of the mitral valve MV.

[0311] Prosthetic valve 2200 has a first body 2210 with an inlet portion 2212 and an outlet portion 2214, and a second body 2210' with an inlet portion 2212' and an outlet portion 2214'. Body 2210 defines a flow passage 2230 extending between an inlet 2231 (shown disposed in the left atrium LA) and an outlet 2235 (shown disposed in the left ventricle LV), and having a flow control device 2260 disposed therein. Similarly, body 2210' defines a flow passage 2230' extending between an inlet 2231' (shown disposed in the left atrium LA) and an outlet 2235' (shown disposed in the left ventricle LV), and having a flow control device 2260' disposed therein. As described above, prosthetic valve 2200 is disposed in a centrally clamped mitral valve, with one body 2210, 2210' disposed in each of flow control portions FCP1 and FCP2. Prosthetic valve 2200 is coupled to the clip CL by a clip connector 2270, which in this embodiment includes a transverse strut 2275 coupled between bodies 2210 and 2210', and a tension member (e.g., suture) 2276 coupled between transverse strut 2276 and the spacer SP of the clip CL. Prosthetic valve 2200 also includes an annulus connector 2280 coupled to both bodies 2210 and 2210', and configured similarly to the annulus connectors of several of the embodiments described above, in this case to engage the ventricular side of the mitral valve annulus MVA.

[0312] Figure 55B A variation of a portion of prosthetic valve 2200 is shown. The outlet portions of bodies 2210, 2210' include leaflet contact regions 2216a, 2216a' that are non-circular in cross-section, extending laterally toward the commissure side of the native mitral valve, which helps to close off the generally triangular portions of the flow control passages FCP1, FCP2 that might otherwise not be filled by bodies 2210 and 2210'. These portions of leaflet contact regions 2216a, 2216a' can be formed of a "filler material" such as dacron or pericardium to create the desired shape on the outside of body frames 2220, 2220'.

[0313] A prosthetic valve according to another embodiment is shown as Figures 56A-56I disposed in a centrally clamped mitral valve MV. Figure 56A , 56BThe prosthetic valve 2300 in 56D and 56E includes a single body 2310, shown as being disposed in one of the two flow control portions FCP1 and FCP2 of the mitral valve MV. Such a prosthetic valve and procedure may be useful when only one flow control portion of a centrally clamped mitral valve (or clamped tricuspid valve) has an unacceptable level of regurgitation requiring treatment.

[0314] The body 2310 of the artificial valve can be implemented according to any of the above options and features. A different aspect of this embodiment is the use of a combination of a suture-based clip connector 2370 and a suture-based cardiac tissue tether 2390 to secure the artificial valve 2300 to a mechanism in operative relation to the mitral valve MV.

[0315] The clip connector 2370 is implemented as an elongated suture 2377 having two suture pleats 2378a and 2378b, which are slidably disposed on the suture 2377. The free ends of the suture 2377 are adjacent, forming a loop between them. The distal (closer to the loop) suture pleat 2378a forms a distal suture loop 2379a with the loop. Figures 56C-56E (Best visible in the middle). The size (periphery) of the distal suture loop 2379a can be adjusted by sliding the distal suture pleat 2378a toward the cord loop (preferably, the suture pleat is configured to slide in one direction and resist sliding in the other direction, so that the suture loop can be tightened around the structure without loosening). The proximal (closer to the free end of the suture 2377) suture pleat 2378b forms the proximal suture loop 2379b with the distal suture pleat 2378a, and is operable to form two loops in the suture 2377 and selectively shorten the length of each loop. As explained in more detail below, the clip connector 2370 is configured such that the distal suture loop 2379a can be disposed around the clip CL and secured by sliding the distal suture pleat 2378a distally (thereby securing the suture 2377 to the clip CL), and the proximal suture loop 2379b can be disposed around the body 2310 of the artificial valve 2300 and secured by sliding the proximal suture pleat 2378b distally (thereby securing the body 2310 to the clip CL via the suture 2377).

[0316] like Figure 56CAs shown, the distal end of the delivery catheter C can be inserted into the left atrium LA (using any suitable technique, such as transseptal delivery), and suture 2377 can be delivered from the delivery lumen of catheter C. Suture 2377 can be delivered in a loop form, i.e., by delivering a loop from catheter C while the free end remains outside the patient's body (e.g., on the leg, for delivery via the femoral artery), and the loop end can be manipulated and controlled using conventional techniques. Thus, the distal suture loop 2379a can be inserted into the left ventricle LV via the flow control unit FCP2, then positioned on the ventricular end of the clip CL, and the free end of suture 2377 can be pulled proximally to push the distal end of the distal suture loop 2379a upward against the upper (atrial) end of the clip CL. The distal suture fold 2378a can then slide distally over suture 2377 to secure the distal suture loop 379a. Alternatively, the free end of suture 2377 can be delivered from catheter C and manipulated and controlled until it is in place. Figure 56C The configuration shown, with the free ends externalized, allows the distal suture to be folded and then applied to the two free ends of suture 2377 outside the main body, pushing suture 2377 downward through catheter C into... Figure 56C At the position shown, then slide the suture 2377 further down to tighten the distal suture loop 2379a.

[0317] like Figure 56C As shown, the same catheter C can then deliver the artificial valve 2300 to the proximal suture loop 2379b. Figure 56C (Not shown in the image). Then, as... Figure 56D and 56E As shown, the main body 2310 of the artificial valve 2300 can be disposed within the flow control unit FCP2, and the proximal suture loop 2379b of the suture 2377 is disposed around the main body 2310 of the artificial valve 2300. The proximal suture fold 2378b can slide distally along the suture 2377 to fix the proximal suture loop around the main body 2310, and the free end of the suture 2377 can be clipped off near the proximal suture fold 2378b – for comparison. Figure 56D and 56E .

[0318] and Figure 56C Compared to the technology shown, Figures 56F-56I Two alternative techniques for setting the distal suture loop 2379a around the clip CL are shown. Figure 56F and 56GIn the technique shown, the distal suture loop 2379a is inserted into the left ventricle (LV) through the flow control section FCP2, and then ascends through another flow control section FCP1 into the left atrium (LA). The free end of the suture 2377 can then pass through the distal suture loop 2379a (e.g., external to the patient) and be pulled proximally to tighten the loop of suture 2377 around the clip CL and the proximal edges of the anterior leaflet AL and posterior leaflet PL. The distal suture pleat 2378a can then be slid distally to secure the distal suture loop 2379a around the clip CL and leaflet tissue. Alternatively, with Figure 56C As shown in the alternative, instead of delivering the loop of suture 2377 via catheter C, the free end of suture 2377 can be delivered into the atrium, wrapped around the clip, and externalized, thereby establishing Figure 56F and 56G The structure shown.

[0319] Figure 56H and 56I Another technique is illustrated. In this technique, the free end of suture 2377 is delivered (e.g., via catheter C) into the left atrium LA, enters the left ventricle LV through flow control section FCP1, flows around the posterior leaflet PL side of clip CL, flows out through flow control section FCP2 into the left atrium LA, crosses the clip CL, returns to the left ventricle LV through flow control section FCP1, flows around the anterior leaflet AL side of clip CL, returns to the left atrium LA from flow control section FCP2, between suture 2377 and the posterior leaflet PL, and then returns from the left atrium LA, and is then externalized from the patient. Tension can be applied to the free end of suture 2377 to tighten the knot around clip CL and the clamping portion of the natural leaflet. Distal suture fold 2378a can then be applied, and suture 2377 can be pushed down into the left atrium LA to form a distal suture loop 2379a.

[0320] As described above, the artificial valve 2300 includes a cardiac tissue tether 2390. Because the artificial valve 2300 is laterally offset from the clip CL, the hydrodynamic forces applied to the artificial valve 2300 during the cardiac cycle (strongly pushing it towards the left atrium LA during systole and less strongly pushing it towards the left ventricle LV during diastole) can exert a rocking force on the artificial valve, i.e., rotation about the clip CL. The upward rocking force (generated during systole) can be counteracted by the cardiac tissue tether 2390. The cardiac tissue tether 2090 can also be implemented with sutures 2393 and suture pleats 2394. Figure 56C and 56EAs best shown, the suture loop 2395 of the suture 2393 can be disposed around sub-leaflet tissue in this case, a chordae tendineae of one of the native leaflets extends between the papillary muscle PM (the one closest to the flow control portion, or in this case, the posterior-medial papillary muscle near the flow control portion FCP2 shown) and the native leaflet. The suture 2393 can be threaded through the flow control portion FCP2 between the valve body 2310 and the mitral annulus MVA, for example near or at the commissure of the valve. The suture 2393 can be anchored against the valve body 2310 by the proximal suture loop 2379b, and then the suture tuck 2394 can be slid distally along the suture 2394 to pull the valve body 2310 down (toward the left ventricle LV and the papillary muscle PM). The downward-directed tension on the valve body 2310 from the suture 2393 opposes the rocking force created by blood pressure during systole, thereby reducing or eliminating rocking of the prosthetic valve 2300 about the clip CL.

[0321] Figure 57A and 57B A prosthetic valve according to another embodiment is shown. The prosthetic valve 2400 is shown disposed in the mitral valve MV, with the clip CL already applied to the anterior leaflet AL and the posterior leaflet PL in an off-center position (i.e., not centered). In this case, the clip CL has been applied to the cusp Al and the cusp PI. Thus, there is a single, large flow control portion FCP1 between the clip and the more proximal commissure (or there can be a very small flow control portion (not shown in the figure)). A distinguishing aspect of this embodiment is the mechanism by which the prosthetic valve 2400 is fixed in operative relationship with the mitral valve MV using a cuff coupled to the clip CL.

[0322] The clip connector 2470 is implemented as a clip connector ring or clip connector cuff ring 2474 that is coupled to the clip CL. The clip connector cuff ring 2474 can be collapsed or compressed into a constrained configuration so as to fit for catheter delivery. The clip connector ring 2474 can be formed of a self-expanding material (e.g., nitinol) and can be coupled to the clip CL outside the patient and delivered with the clip, for example, through a catheter, and disposed on the ventricular side of the anterior leaflet AL and the posterior leaflet PL. The clip can be engaged with the leaflets, and the clip connector ring 2474 can then be released from the delivery catheter. The clip connector ring 2474 can then self-expand and elastically return to an unconstrained expanded configuration (as shown in the figure) that is coupled to the clip CL and holds the clip CL in place on the leaflets. Figure 57BThe artificial valve 2400 is shown as being delivered (e.g., through the same delivery catheter used to deliver the clip CL and the clip connector ring 2474) into the left atrium LA with the body 2410 disposed in the flow control portion FCP1 and the clip connector ring 2474, and the body 2410 can be inflated (or allowed to self-inflate) to securely engage with the clip connector ring 2474, as shown in Figure 57A and 57B .

[0323] Figure 58A and 58B An artificial valve according to another embodiment is shown. The artificial valve 2500 is also shown as being disposed in the eccentrically clamped mitral valve MV. The difference in this embodiment is the mechanism used to secure the artificial valve 2500 in operative relationship with the mitral valve MV using struts extending from the clip CL.

[0324] The clip connector 2570 is shown with two slight variations in these figures. In Figure 58A , the clip connector 2570 includes a vertically oriented U-shaped clip post 2573 extending laterally from the frame of the body 2510. The free end of the clip post 2573 can be coupled to the clip CL through any of the mechanical coupling options described above. For example, the terminal end of the clip post 2573 can be inserted into a suitably configured opening 2574 in the spacer of the clip CL.

[0325] In Figure 58A , the clip connector 2570 includes an axial clip post 2573 extending vertically from the clip CL and it engages with a strut 2575 extending laterally from the frame of the body 2510.

[0326] As shown in Figure 58A and 58B , the artificial valve 2500 includes an annulus connector 2580, which is similar to the annulus connectors in many of the embodiments described above.

[0327] Figure 59A and 59B An artificial valve according to another embodiment is shown. The artificial valve 2600 is also shown as being disposed in the eccentrically clamped mitral valve MV. The difference in this embodiment is the mechanism used to secure the artificial valve 2600 in operative relationship with the mitral valve MV, which essentially combines features of the artificial valve 2300 Figures 56A-56I and the artificial valve 2500 Figure 58A and 58B .

[0328] The clip connector 2670 includes an L-shaped axial post 2673 extending from the clip CL (similar to the axial post 2573 of the prosthetic valve 2500), and a distal suture loop 2678a coupled to the post 2673 and secured around the body 2610 (similar to the suture 2377 of the prosthetic valve 2300).

[0329] As shown in Figure 59A and 59B , the prosthetic valve 2600 includes a leaflet connector 2680, similar to the leaflet connectors in many of the embodiments described above.

[0330] Similar to the prosthetic valve 2300, the prosthetic valve 2600 also includes a heart tissue tether 2690 disposed around the chordae tendinae CT.

[0331] A prosthetic valve according to another embodiment is shown in Figures 60A-60D . The prosthetic valve 2700 is also shown disposed in an eccentrically clamped mitral valve MV. This embodiment is very similar to the prosthetic valve 2300 Figures 56A-56I , but has a slightly different coupling mechanism for the clip connector 2770.

[0332] Similar to the clip connector 2370 of the prosthetic valve 2300, the clip connector 2770 includes an elongated suture 2777, but only has one suture tuck, a proximal suture tuck 2778b, which forms a proximal suture loop 2779b with a loop of the suture 2777, which is configured to be disposed around the body 2710 of the prosthetic valve 2700, and tightened by sliding the proximal suture tuck 2778b distally (thus securing the body 2710 to the clip CL via the suture 2777). In this embodiment, the suture 2777 has a single free end, and the other end is fixed to the atrial side of the clip CL.

[0333] Similar to the prosthetic valve 2300, the prosthetic valve 2700 also includes a heart tissue tether 2790, with a suture 2793, a suture loop 2795 disposable around the chordae tendinae CT, and a suture tuck 2794. Two variations of the heart tissue tether 2790 are shown in Figure 60C and 60D . In the variation shown in Figure 60C , the heart tissue tether 2790 engages with the papillary muscle PM, rather than the chordae tendinae CT. The suture 2793 is passed through the papillary muscle PM (e.g., by piercing the papillary muscle PM with a needle coupled to the suture 2792 and pulling the suture 2794 through). Alternatively, an anchor (screw, hook, loop, etc. - not shown) can be coupled to the papillary muscle PM, and the suture 2793 can be coupled to or passed through the anchor. Figure 60DIn the illustrated variation, the heart tissue tether 2790 includes a tissue anchor 2792, illustratively shown as a button or pledget, which can be disposed outside the ventricular wall VW (epicardially), for example at the apex of the ventricle, and a suture 2793 can be secured to the tissue anchor 2793.

[0334] Figure 61A and 61B An artificial valve according to another embodiment is shown. The artificial valve 2800 is also shown disposed in an eccentrically clamped mitral valve MV. The difference in this embodiment is that the clip combines clamping, spacing and occlusion functions, thereby achieving a larger flow control portion, thereby achieving a larger flow control device, effectively sealing paravalvular leaks.

[0335] As Figure 61A shown, the body 2810 of the artificial valve 2800 is disposed in a flow control passage FCP1 formed by eccentrically clamping the posterior leaflet PL and the anterior leaflet AL (i.e., not in the center, in this case by clamping the A1 and P1 cusp tips). The artificial valve 2800 is similar to other artificial valves disclosed above, for example the artificial valve 2500 shown in Figure 58A and 58B and similarly includes an axial clip post 2873 (as part of the clip connector 2870) similar to the posts 2573 of the artificial valve 2500.

[0336] Clamping the native leaflets with the clip CL, as shown in more detail in Figure 61B The clip CL includes a spacer SP, a first paddle P1, a second paddle P2 and a post connector PC, to which the axial clip post 2873 can be secured by any suitable mechanism (as described in more detail above). As shown in Figure 61A the anterior leaflet is secured to the clip CL between the paddle P2 and the spacer SP, and the posterior leaflet PL is secured to the clip C1 between the paddle P1 and the spacer. As can be seen from Figure 61A the spacer SP has a significant width between the paddles P1 and P2, such that when the native leaflets are secured on the clip CL, their coaptation edges are separated, rather than being brought together as in the MitraClip TMSuch clips are closer together. This spaced-apart clipping creates a larger (longer perimeter, greater flow area) flow control portion FCP1 than if the leaflet AL, PL edges were clipped directly together. In turn, this enables placement of a larger diameter prosthetic valve body 2810 with a larger flow area. The leaflet AL, PL edges can sealingly engage the V-shaped (from a top view) leaflet surface LS of the spacer SP, and the sides of the valve body 2810 can sealingly engage the valve surface VS of the clip CL. The spacer SP substantially fills the triangular space between the leaflets AL, PL, commissure (anterior-lateral commissure ALC), and the prosthetic valve 2800, thus also functioning as an occluder. Throughout the cardiac cycle, the clipped edges of the anterior leaflet AL and the posterior leaflet PL maintain a fixed spatial relationship to each other. At no stage of the cardiac cycle does blood flow past the occluder and between the clipped leaflet edges. Thus, paravalvular blood leakage or regurgitation between the atrium and ventricle is reduced or eliminated.

[0337] The prosthetic valve 2800 also includes an annulus connector 2880, which in this embodiment is disposed beneath the native annulus, resisting fluid forces oriented upward (toward the atrium), such as during systole. A distinguishing aspect of this embodiment is having clips with the structure and function of a spacer-occluder. The mechanism for securing the prosthetic valve 2600 in operable relationship with the mitral valve MV substantially incorporates the features of the prosthetic valve 2300 Figures 56A-56I ) and the prosthetic valve 2500 Figure 58A and 58B ).

[0338] Figure 62 A prosthetic valve according to another embodiment is shown. The prosthetic valve 2900 is shown disposed in a mitral valve that has been clipped by two spaced-apart clips CL, forming a single large flow control portion FCP1 between them. The body 2910 of the prosthetic valve 2900 can be secured to at least one clip CL, and preferably to both clips CL, using any of the structures and techniques described above for other embodiments. For example, as shown in Figure 62 the prosthetic valve 2900 includes a clip connector 2970 that includes a collar 2974, similar to the clip connector collar 2474 described above for the prosthetic valve 2400 Figure 57A and 57B ). The collar 2974 is preferably coupled to both clips CL, thereby preventing wobbling of the prosthetic valve 2900. Alternatively, the clip connector 2970 can be implemented with a suture loop, such as described above for the prosthetic valve 2300 Figures 56A-56I ), 2600 Figure 59A and 59B ) or 2700Figure 60A and 60B ) as described above. In this way, securing the body 2910 to the appropriately sized collar 2974 prevents undue stress or over-tensioning of the free edge lengths of the anterior and posterior leaflets AL, PL defined between the spaced-apart clips CL.

[0339] As described above, many embodiments of the artificial valve described above can be used to address regurgitation of the mitral or tricuspid valve. Figures 63-66 Some example applications of the tricuspid valve are shown.

[0340] As shown in FIG. 63, the tricuspid valve TV has been clipped with two clips CL in a three-hole technique (as described above with reference to FIGS. 48-49). This creates three flow control portions, namely FCP1 (the largest) and FCP2 and FCP3 (the smaller ones). Figure 63 Figure 38E and 38F This creates three flow control portions, namely FCP1 (the largest) and FCP2 and FCP3 (the smaller ones). Figure 63 An artificial valve 3000 is shown disposed in the flow control portion FCP1. In FIG. 62, the heart is in systole such that all the leaflets (including the leaflets in the artificial valve) are in the closed position. The artificial valve 3000 is shown with an annulus connector 3080 that engages the atrial side of the tricuspid annulus, and / or the artificial valve 3000 can include heart tissue tethers or any of the other mechanisms described above to secure the artificial valve in place relative to the native valve. In addition, the artificial valve 3000 includes a clip connector 3070 that is shown with axial clip posts 3073 that connect to the two clips CL. However, in other variations, any of the clip connector embodiments described above can be used to secure the artificial valve 3000 to the clips CL. Figure 63 As shown in FIG. 63, the tricuspid valve TV has been clipped with two clips CL in a three-hole technique (as described above with reference to FIGS. 48-49). This creates three flow control portions, namely FCP1 (the largest) and FCP2 and FCP3 (the smaller ones).

[0341] Figure 64A As shown in FIG. 63, the tricuspid valve TV has been clipped with two clips CL in a three-hole technique (as described above with reference to FIGS. 48-49). This creates three flow control portions, namely FCP1 (the largest) and FCP2 and FCP3 (the smaller ones). Figure 64B An artificial valve 3100 is shown disposed in the flow control portion FCP1. In FIG. 64, the heart is in systole such that all the leaflets (including the leaflets in the artificial valve) are in the closed position. The artificial valve 3100 is shown with a clip connector 3170 that includes three eyelets 3172 radially protruding from a body 3110, which eyelets 3172 can be engaged with suture lines 3177 each extending from a respective clip CL and having a length from the clip CL to the respective eyelet 3172 through a distal suture tuck 3178a (easiest to see in FIG. 64). Figures 65A-65D The suture lines 3177 can conveniently serve as a guidewire through which each clip CL is delivered to the tricuspid valve TV. The delivery process for the clips CL and the artificial valve 3100 is shown in FIG. 65. ​​

[0342] As Figure 65A shown, the delivery system for the clips CL and the prosthetic valve 3100 includes a catheter C that supports the prosthetic valve 3100 for delivery through a valve delivery sheath VDS. The valve delivery sheath VDS includes eyelet slots ES through which the eyelets 3172 can radially protrude. The valve delivery sheath VDS is disposed in the lumen of a clip delivery cannula CDC through which the clips CL can be delivered. Each clip CL has its delivery guide wire, which in this embodiment is the suture 3177 of the clip connector 3170. The suture 3177 passes through the eyelet 3172, and the clip CL is disposed distal to the suture 3177, away from the eyelet 3172. Each of the three clips CL can be delivered sequentially to the tricuspid valve as Figures 65B-65D shown, each clip clamping an adjacent pair of leaflets (as Figures 65B-65D shown, by way of example only, the first clip CL clamps the anterior leaflet AL to the septal leaflet SL, the second clip CL clamps the septal leaflet SL to the posterior leaflet PL, and the third clip CL clamps the anterior leaflet AL to the posterior leaflet AL), thereby forming Figure 64A the clamped tricuspid valve as shown. The prosthetic valve 3100 can then be advanced out of the clip delivery cannula CDC from the valve delivery sheath VDS and positioned in the flow control portion FCP1. The proximal end of each of the sutures 3177 can then be tensioned (e.g., from outside the patient’s body), and the distal suture tuck 3178a is pushed onto the suture 3178 and against the eyelet 3172, thereby securing the prosthetic valve 3100 to the clip CL. The sutures 3177 can then be clipped or cut proximal to the distal suture tuck 3178a, and the delivery system is removed from the patient.

[0343] As Figure 66 shown, the tricuspid valve TV has been clamped with three clips CL in a “double-leaflet” clamping technique (as described above with reference to Figure 38C and 38D ), which results in a single control portion FCP1. Figure 66 A prosthetic valve 3200 is shown disposed in the flow control portion FCP1. In Figure 66In this configuration, the heart is in a contracted state, causing all leaflets (including those in the prosthetic valve) to be in the closed position. The prosthetic valve 3000 is shown with an annular connector 3280 that engages with the atrial side of the tricuspid annulus; however, in other variations, said (or another) annular connector 3280 may engage with the ventricular side of the tricuspid annulus, and / or the prosthetic valve 3200 may include a cardiac tissue tether or any other of the aforementioned mechanisms to secure the prosthetic valve in place relative to the natural valve. Furthermore, the prosthetic valve 3200 includes a clip connector 3270, shown with an axial clamp post 3273 coupled to the clip CL closest to the valve body 3210. However, in other variations, any of the above-described clip connector embodiments may be used to secure the prosthetic valve 3200 to one or more clips CL.

[0344] As described above, any artificial valve embodiment described herein may include a cardiac tissue tether located between the artificial valve and cardiac tissue, such as on the ventricular side of the natural atrioventricular valve, which can provide tension against the hydrodynamic forces exerted on the artificial valve during contraction, which would tend to cause the artificial valve to shift toward the atrium and / or rock the artificial valve relative to the plane of the natural valve. As noted in the description of artificial valves 100 and 2000, such a cardiac tissue tether may be coupled to a clip connector and / or a clip (and other options). Figures 67A-67C A cardiac tissue tether 3390 that can be coupled between a clamp CL and the ventricular apex VA of the heart is shown, along with a method for delivering the cardiac tissue tether 3390 and the clamp CL to the heart. Figure 67A As shown, the cardiac tissue tether 3390 can be delivered into the left ventricle (LV) via catheter C. The cardiac tissue tether 3390 includes a tether anchor 3392 and a suture 3393, which can be used as a guidewire during delivery of the cardiac tissue tether 3390. Figure 67A In the diagram, the tether anchor 3392 is shown in two locations: a first location near the middle of the left ventricle (LV) during delivery, in a delivery (closed or constricted) configuration, positioned distal to the suture 3393; and a second location on the epicardial surface of the ventricular apex (VA) in an unfolding (expanded) configuration, positioned distal to the suture 3393 after the puncture through the ventricular apex (VA) (shown as dashed lines for the delivery location).

[0345] exist Figure 67B The image shows a clip CL delivered from catheter C through suture 3393 into the left ventricle (LV), the suture passing through the lumen of clip C and serving as a guidewire for delivery of clip CL. Suture 3393 is not taut, thus allowing the delivery catheter through it to fully manipulate, position, and orient clip CL, including closing blades P1 and P2 to engage the natural leaflets.

[0346] In Figure 67C The clip CL is shown fully deployed, i.e. having clamped the native leaflets together. The free end of the suture 3393 can be tensioned, and the suture tuck 3394 pushed distally away from the suture 3394, against the clip CL, and then secured to the suture 339 to secure a length of the suture 3392 between the ventricular apex VA and the clip CL, and to provide the required tension on the clip CL. At this point in the procedure, the suture 3395 can be clipped or cut at the proximal end of the suture tuck 3394, and the remainder of the suture 3393 withdrawn. Any of the above artificial valves can then be delivered to the native valve (e.g. via a catheter C), and secured to the clip CL with a suitable clip connector. The heart tissue tether 3390 is then used to counter the fluid dynamics exerted on the artificial valve.

[0347] While various embodiments are described herein with textual and / or graphical descriptions, it is to be understood that such embodiments are presented by way of example only, and not limitation. As such, it is to be understood that the specific order or hierarchy of steps or actions in the processes described herein are an illustration of exemplary processes. Based upon implementation-specific or other considerations, the specific order or hierarchy of steps or actions in the processes can be varied. Specifically, the

[0348] For example, while artificial valves are described herein as being used with particular native valve and clip configurations, it is to be understood that they are presented by way of example only, and not limitation. Unless otherwise expressly stated, the embodiments and / or devices described herein are not limited to any particular implementation.

[0349] Where the above-described diagrams, embodiments, and / or implementations indicate certain components being arranged and / or configured in a particular manner, the arrangement of the components can be modified, adjusted, optimized, etc. The particular size and / or shape of various components can differ from the illustrated embodiments while still providing the functionality as described herein. More particularly, the size and shape of the various components can be specifically selected for a desired or intended use. Thus, it should be understood that the size, shape, and / or arrangement of the embodiments and / or components thereof can be adapted to a given use, unless the context clearly dictates otherwise. As an example, a therapy device intended to provide therapy to an adult user can have a first size and / or shape in some implementations, while a therapy device intended to provide therapy to a child user can have a second size and / or shape that is smaller than the first size and / or shape. Further, for example, the smaller size and / or shape of the child therapy device can result in certain components being moved, reoriented, and / or rearranged, while maintaining the desired functionality of the device.

[0350] While various embodiments have been described as having particular features, functions, components, elements, and / or characteristics, other embodiments can include any combination of features, functions, components, elements, and / or characteristics described herein, or from any of the described embodiments, unless the context clearly indicates otherwise. Additionally, any particular combination of components, functions, features, elements, etc. can be separated and / or combined into independent components, functions, features, elements, etc. unless the context clearly indicates otherwise, or unless the combination is mutually exclusive and / or the context clearly indicates otherwise.

[0351] While the above-described methods indicate certain events occurring in a particular order, the order of the particular events can be modified. Further, if possible, the particular events can be performed concurrently, and / or in a different order, than as described above. While methods have been described as having particular steps and / or combinations of steps, other methods can have any combination of steps from any of the methods described herein, unless the context clearly indicates otherwise, and / or unless the combination is mutually exclusive and / or the context clearly indicates otherwise.

Claims

1. A prosthetic valve, comprising: a body comprising an inlet portion and an outlet portion having a first leaflet and a second leaflet, and defining a flow passage having an inlet in the inlet portion, a first outlet in the first leaflet, and a second outlet in the second leaflet; a flow control device disposed in the flow passage within the inlet portion and configured to allow fluid flow through the flow passage in a first direction from the inlet to the first and second outlets, and to prohibit fluid flow through the flow passage in a second direction opposite the first direction; and a clip connector coupled to the body; the prosthetic valve configured to be disposed in a native valve of a heart with a first valve leaflet coupled to a second valve leaflet by a clip, defining a first flow control portion between the first valve leaflet, the second valve leaflet, and the clip, and defining a second flow control portion between the first valve leaflet, the second valve leaflet, and the clip, the inlet disposed in an atrium of the heart, and the first and second outlets disposed in a ventricle of the heart; the first leaflet configured to be disposed in the first flow control portion in substantially sealing relation with the first and second valve leaflets, the second leaflet configured to be disposed in the second flow control portion in substantially sealing relation with the first and second valve leaflets; the prosthetic valve configured to allow blood flow from the atrium to the ventricle through the inlet, the flow control device, the flow passage, and the first and second outlets during diastole of the heart, and to substantially prevent blood flow from the ventricle to the atrium through the flow passage or between the body and the valve leaflets during systole of the heart, and the clip connector configured to selectively couple to the clip and resist displacement of the body toward the atrium during systole.

2. The prosthetic valve of claim 1, further comprising an annulus connector coupled to the body and configured to selectively engage an annulus of the native valve and resist movement of the body during systole and / or diastole of the heart. the annulus connector comprising a first arm extending from the body and a first annulus anchor coupled to a distal end of the first arm, the first annulus anchor configured to engage the annulus of the native heart valve.

3. The prosthetic valve of claim 2, wherein, the annulus connector comprising a second arm extending from the body opposite the first arm and a second annulus anchor coupled to a distal end of the second arm, the second annulus anchor configured to engage the annulus of the native heart valve.

4. The prosthetic valve of claim 3, wherein, the annulus connector configured to engage an atrial side of the native valve annulus.

5. The prosthetic valve of any of claims 2-3, wherein, the annulus connector configured to engage a ventricular side of the native valve annulus.

6. The prosthetic valve of any of claims 2-4, wherein, ​ 7. The prosthetic valve of claim 2, further comprising a heart tissue tether coupled to any one of the body, the clip connector, or the annulus connector, and comprising a tether anchor configured to be secured to heart tissue, the heart tissue tether configured to transmit fluid dynamic loads exerted on the prosthetic valve during a cardiac cycle to the heart tissue to aid in retaining the prosthetic valve in a desired position in the native heart valve.

8. The prosthetic valve of any of claims 1-4, wherein, The flow control device is a tri-leaflet valve.

9. The prosthetic valve of any of claims 1-4, wherein, The flow control device includes a valve frame, a first tissue leaflet coupled to the valve frame, a second tissue leaflet coupled to the frame and disposed diametrically opposite the first tissue leaflet, each tissue leaflet facing about one-third of a perimeter of the valve frame, a first static half-lunule coupled to the valve frame between the first and second tissue leaflets, and a second static half-lunule coupled to the valve frame between the first and second tissue leaflets and diametrically opposite the first static half-lunule, each static half-lunule facing about one-sixth of the perimeter of the valve frame; The tissue leaflets are sealably engageable with the static half-lunules to prevent fluid flow therebetween in a first direction and to allow fluid flow therebetween in a second direction opposite the first direction.

10. The prosthetic valve of claim 9, wherein, Each static half-lunule includes a static cusp frame coupled to the valve frame and a static cusp membrane supported on the static cusp frame and disposed in sealable engagement with the tissue leaflets.

11. The prosthetic valve of claim 1, wherein, The outlet portion has a third lobe having a third outlet, the clip is a first clip, the prosthetic valve is configured to be disposed in a native valve of a heart, wherein the first lobe has been coupled to the second lobe by a second clip, or the first lobe has been coupled to a third lobe by the second clip, the second clip partially defining a third flow control portion, the third lobe is configured to be disposed in the third flow control portion.

12. The prosthetic valve of claim 1, wherein, The body includes a body covering, each of the first and second lobes includes a leaflet contact area against which the native leaflet can sealably engage when the lobe is disposed in the flow control portion, the body covering is formed of tissue.

13. The prosthetic valve of claim 1, wherein, The body includes a body covering, each of the first and second lobes includes a leaflet contact area against which the native leaflet can sealably engage when the lobe is disposed in the flow control portion, the body covering in the leaflet contact area is formed of tissue.

14. The prosthetic valve of claim 12 or 13, wherein, The body includes a body frame having a stent frame wire mesh configuration for portions of the body that are not leaflet contact areas, the body frame has a lesser structural rigidity in a radial direction in leaflet contact areas such that the body covering is relatively more pliable so that it exerts less stress on native leaflets that contact the leaflet contact areas.

15. The prosthetic valve of claim 1, wherein, Each of the first and second leaflets includes an outlet flange at its outlet end, the outlet flange including a filler material to reduce the risk of injury to heart tissue that can contact the outlet end of the leaflets.

16. The prosthetic valve of claim 1, wherein, The clip connector includes an axial clip post extending from the body and having a first end coupleable to the clip via a mechanical joint, and a plurality of radial valve struts coupled at their lower ends to a second end of the axial clip post and at their upper ends to a frame of the flow control device.

17. The prosthetic valve of claim 16, wherein, The radial valve struts are disposed on a ventricular side of a line of coaptation of tissue leaflets disposed in the flow control device.

18. A prosthetic valve, comprising: a body including an inlet portion and an outlet portion and defining a flow passage; the flow passage having an inlet in the inlet portion and an outlet in the outlet portion; a flow control device disposed in the flow passage within the inlet portion and configured to allow fluid to flow through the flow passage in a first direction from the inlet to the outlet and to prohibit fluid from flowing through the flow passage in a second direction opposite the first direction; and a clip connector coupled to the body, the prosthetic valve configured to be disposed in a native valve of a heart with a first leaflet coupled to a second leaflet by a clip defining a flow control portion between the first leaflet, the second leaflet, and the clip, the inlet disposed in an atrium of the heart and the outlet disposed in a ventricle of the heart; the outlet portion configured to be disposed in the flow control portion in substantially sealing relation with the first leaflet and the second leaflet; the prosthetic valve configured to allow blood to flow from the atrium to the ventricle through the inlet, the flow control device, the flow passage, and the outlet during diastole of the heart and to substantially prevent blood from flowing through the flow passage or between the body and the leaflets from the ventricle to the atrium during systole of the heart, and the clip connector configured to selectively couple to the clip and to resist displacement of the body toward the atrium during systole.

19. The prosthetic valve of claim 18, further comprising an annulus connector coupled to the body and configured to selectively engage an annulus of the native valve and to resist movement of the body during systole and / or diastole of the heart.

20. The prosthetic valve of claim 19, wherein, the annulus connector including a first arm extending from the body and a first annulus anchor coupled to a distal end of the first arm, the first annulus anchor configured to engage the annulus of the native heart valve.

21. The prosthetic valve of claim 20, wherein, the annulus connector including a second arm extending from the body opposite the first arm and a second annulus anchor coupled to a distal end of the second arm, the second annulus anchor configured to engage the annulus of the native heart valve.

22. The prosthetic valve of any of claims 19-20, wherein, the annulus connector configured to engage an atrial side of the native valve annulus.

23. The prosthetic valve of any of claims 19-20, wherein, the annulus connector configured to engage a ventricular side of the native valve annulus.

24. The prosthetic valve of claim 19, further comprising a heart tissue tether coupled to any one of the body, the clip connector, or the annulus connector, and comprising a tether anchor configured to secure to heart tissue, the heart tissue tether configured to transmit fluid dynamic loads exerted on the prosthetic valve during a cardiac cycle to the heart structure to aid in retaining the prosthetic valve in a desired position in the native heart valve.

25. The prosthetic valve of any of claims 18-21, wherein, The flow control device is a tri-leaflet valve.

26. The prosthetic valve of claim 18, wherein the clip is a first clip, the body is a first body, the inlet portion is a first inlet portion, the outlet portion is a first outlet portion, the flow passage is a first flow passage, the inlet is a first inlet, the outlet is a first outlet; and further comprising a second body comprising a second inlet portion and a second outlet portion and defining a second flow passage having a second inlet in the second inlet portion and a second outlet in the second outlet portion, wherein, The prosthetic valve is configured to be disposed in a native valve of a heart, wherein the first leaflet is coupled to the second leaflet by a second clip, or the first leaflet is coupled to a third leaflet by the second clip, the second clip partially defining a second flow control portion, the second outlet portion configured to be disposed in the second flow control portion.

27. The prosthetic valve of claim 18, wherein, The clip connector comprises an axial clip post extending from the body and having a first end coupleable to the clip by a mechanical joint.

28. The prosthetic valve of claim 18, wherein, The native valve is a mitral valve, the first leaflet is an anterior leaflet, and the second leaflet is a posterior leaflet.

29. The prosthetic valve of claim 28, wherein, The clip is coupled to a central portion of each of the anterior leaflet and the posterior leaflet, defining the first flow control portion between the anterior leaflet, the posterior leaflet, a posteromedial commissure of the mitral valve, and the clip, and defining a second flow control portion between the anterior leaflet, the posterior leaflet, an anterolateral commissure of the mitral valve, and the clip, the first flow control portion and the second flow control portion having substantially equal flow areas.

30. The prosthetic valve of claim 28, wherein, The clip is eccentrically coupled to the anterior leaflet and the posterior leaflet, defining the first flow control portion between the anterior leaflet, the posterior leaflet, a posteromedial commissure of the mitral valve, and the clip, and defining a second flow control portion between the anterior leaflet, the posterior leaflet, an anterolateral commissure of the mitral valve, and the clip, the first flow control portion having a substantially greater flow area than a flow area of the second flow control portion.

Images