CN116568240A

CN116568240A - Heart valve prosthesis and related methods

Info

Publication number: CN116568240A
Application number: CN202180053636.0A
Authority: CN
Inventors: P·思朋斯; A·保利托
Original assignee: Inverwood Treatment Co
Current assignee: Inverwood Treatment Co
Priority date: 2020-07-01
Filing date: 2021-07-01
Publication date: 2023-08-08
Also published as: WO2022006375A1; EP4175589A1

Abstract

Prosthetic valves for treating regurgitation of blood through a native heart valve may include: a body comprising an inlet portion and an outlet portion having a first flap and a second flap, and defining a flow channel having an inlet in the inlet portion, a first outlet in the first flap, and a second outlet in the second flap; and a flow control device disposed in the flow channel 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 clamped to create a first flow control portion and a second flow control portion, wherein the inlet is disposed in an atrium of the heart and the first outlet and the second outlet are disposed in a ventricle of the heart, wherein the valve is configured to be disposed in the flow control portion in substantially sealing relation to the first leaflet and the second leaflet. The prosthetic valve is also configured to allow blood to flow from the atrium to the ventricle through the flow channel and to substantially prevent blood from flowing from the ventricle to the atrium through the flow channel or between the body and the leaflet during systole. The clip connector is configured to selectively couple to the clip and resist displacement of the body toward the atrium during contraction.

Description

Heart valve prosthesis and related methods

Cross Reference to Related Applications

The present application claims priority from U.S. provisional patent application Ser. No.63/046,841, entitled "Mitral Valve Protheses and Related Methods," filed on 7/1/2020, the disclosure of which is incorporated herein by reference in its entirety.

The present application is also directed to U.S. patent No.10,912,646, entitled Methods, apparatus and Devices to Treat Heart Valves "("' 646 patent "), the disclosure of which is incorporated herein by reference in its entirety.

Background

Heart valve insufficiency, which has various forms and affects various heart valves such as aortic valve, tricuspid valve, pulmonary valve and mitral valve, has led to an expanding research and development field aimed at improving heart valve function. Although any one or more of these native heart valves may be damaged due to, for example, congenital diseases or more common disease conditions, mitral valves have received particular attention. When the valve should be fully closed (i.e., full coaptation of the native leaflets), regurgitation through the heart valve (e.g., mitral valve) involves backflow of blood through the valve. Mitral valve lesions or lesions typically allow regurgitated blood to flow from the left ventricle into the left atrium during systole. This results in a decrease in the amount of blood ejected from the left ventricle during systole, resulting in a less than optimal "ejection fraction (ejection fraction)" for the patient. Thus, patients may experience lower quality of life due to heart inefficiency or worse life threatening conditions.

Surgical techniques as well as transvascular or catheter-based techniques for treating mitral insufficiency have been developed and include, for example, mitral annuloplasty, attaching the native anterior mitral leaflet to the native posterior mitral leaflet, chordal replacement, and even complete mitral valve replacement. Similar approaches have been developed to treat tricuspid insufficiency.

In many cases, mitral regurgitation is not associated with congenital defects in the mitral valve leaflets, but rather with changes in leaflet coaptation over time due to heart disease. In these cases, the native mitral valve leaflets are typically relatively normal, but they still fail to prevent backflow of blood from the left ventricle to the left atrium during systole. In contrast to properly matching or fully coapting the native anterior and posterior leaflets together during systole or systole, one or more gaps between the native leaflets can result in mitral regurgitation. Similar problems are encountered with tricuspid valves.

A current common technique for reducing mitral regurgitation is an edge-to-edge approximation or repair procedure that involves attaching a native mitral anterior leaflet to a native mitral posterior leaflet using a clip structure. The use of edge-to-edge mitral valve repair to treat mitral regurgitation is rapidly increasing. Abbott has marketed MitraClip ^TM And Edwards recently introduced pass devices. MitraClip ^TM While the anterior mitral leaflet is fastened or clipped to the posterior mitral leaflet, paspal achieves the same function by adding material between the natural leaflets, providing certain advantages for the procedure.

MitraClip ^TM Prostheses currently use approximately two clips per procedure, and mitral regurgitation still exists in many patients undergoing treatment. The natural anterior and posterior mitral valve leaflets present gaps between systoles that can lead to continued mitral regurgitation even after they are clamped together. Clinical studies have shown that the use of clips can improve patient prognosis, but many patients remain ill and require continuous strict medical supervision. Abbott also developed TriClip for grasping the natural leaflet of the tricuspid valve ^TM 。

The' 646 patent discloses a device that attaches to an edge-to-edge mitral valve clamp device 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, others have moving parts or leaflets that close the residual gap during systole and allow blood to enter the left ventricle during diastole.

One particularly promising variation disclosed in the' 646 patent is a bileaflet valve positionable and attachable to an edge-to-edge clip. Many variations in this solution have been shown, including (but not limited to) fig. 5-11, 15-29, and 35 of the' 646 patent, also included herein.

Each of these variants requires the development of a new valve-typically a bileaflet valve-that fills the gaps between the natural leaflets during systole and moves during diastole to allow blood to enter the Left Ventricle (LV). Such valves require extensive testing and development prior to clinical use. There is no such similar two-leaf device on the market. Thus, such new devices may fail, with development and regulatory risks. It is also possible that the double leaflet device would not be popular with doctors who have used tri-leaflet valves for more than 50 years.

Tri-leaflet stent valves have proven to be effective and safe. For over 50 years, it has been the mainstay of surgical tissue valves, and millions of valves with a tri-leaflet structure have been implanted in patients with good long-term results. Over the past decade, hundreds of thousands of stent-valves with three leaflets have been successfully used in patients undergoing catheter-based heart valve replacement surgery. It is contemplated that the use of two proven techniques (edge-to-edge devices and tri-leaflet stent valves) is very useful for treating mitral regurgitation. These combinations will reduce the time to market and the risk of supervision and adoption, in addition to clinical advantages.

Many doctors are now performing mitral valve clamping (using techniques such as MitraClip ^TM The isosbestic clips clip the anterior and posterior leaflets together) and tricuspid valve pinching are both very well done (using a device such as MitraClip ^TM The clips may clip the anterior leaflet, the spacer leaflet, and/or the posterior leaflet together). They are also confident in their reliability and ability to deliver stent-valves. Construction of a device using these validated implants and skill sets will beTo the welcome of doctors and safer for those patients who are familiar with the operation performed by the doctor.

It would be useful to further address these and other problems or challenges associated with heart valve insufficiency.

Disclosure of Invention

In some embodiments, the prosthetic valve comprises: a body including an inlet portion and an outlet portion having a first flap and a second flap; and defines a flow channel having an inlet in the inlet portion, a first outlet in a first flap (limb, flap, limb) and a second outlet in a second flap; a flow control device is disposed in the flow channel within the inlet portion 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 the first direction. The prosthetic valve is configured to be disposed in a native valve of a heart, wherein the first leaflet has been coupled to the second leaflet by a clip, a first flow control is defined between the first leaflet, the second leaflet, and the clip, and a second flow control is defined between the first leaflet and the second leaflet and the clip, wherein the inlet is disposed in an atrium of the heart, and the first outlet and the second outlet are disposed in a ventricle of the heart. The first leaflet is configured to be disposed in a first flow control portion in substantially sealing relation to the first leaflet and the second leaflet, and the second leaflet is configured to be disposed in a second flow control portion in substantially sealing relation to 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 inlet, the flow control device, the fluid channel, and the first and second outlets during diastole, and to substantially prevent 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.

In other embodiments, a prosthetic valve has a body including an inlet portion and an outlet portion and defining a flow passage having an inlet and an outlet portion in the inlet 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 inhibit 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 is configured to be disposed in a native valve of a heart, wherein the first leaflet has been coupled to the second leaflet by a clip, a flow control portion is defined between the first leaflet, the second leaflet, and the clip, an inlet is disposed in an atrium of the heart, and a first outlet is disposed in a ventricle of the heart. The outlet portion is configured to be disposed in the flow control portion in substantially sealing relation to the first leaflet and the second leaflet. The prosthetic valve is configured to allow blood to flow from the atrium to the ventricle through the inlet, the flow control device, the fluid channel, and the outlet during diastole and to substantially prevent blood from flowing from the ventricle to the atrium through the flow channel or between the body and the leaflet during systole. The clip connector is configured to selectively couple to the clip and resist displacement of the body toward the atrium during contraction.

Additional features, aspects, and/or advantages will be recognized and appreciated upon further review of the detailed description of the exemplary embodiments in conjunction with the drawings.

Drawings

FIG. 1A is a schematic diagram illustrating a system constructed in accordance with an example embodiment.

Fig. 1B is a schematic perspective view of a native left atrium and mitral valve similar to fig. 1A, but showing the installation of a catheter-delivered selective occlusion device.

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.

Fig. 2A is a cross-sectional view taken across the selective occlusion device along line 2A-2A of fig. 3A when the cardiac cycle is in systole.

Fig. 2B is a cross-sectional view similar to fig. 2A taken along line 2B-2B of fig. 3A during the systolic phase of the cardiac cycle.

Fig. 2C is a cross-sectional view similar to fig. 2B, but showing the native mitral valve and the selective occlusion device in the diastolic phase of the cardiac cycle.

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

Fig. 3B is a top view similar to fig. 3A, but showing the device and native mitral valve when the heart is in diastole.

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.

Fig. 4B is a perspective view similar to fig. 4A, but showing the membrane applied to the frame structure of the device.

Fig. 5A is a schematic perspective view, similar to the partial cross-sectional view of fig. 1A, but showing a catheter-based or transcatheter delivery and implantation system constructed in accordance with another embodiment.

Fig. 5B is a view similar to fig. 5A, but showing a subsequent step in the method, in which the native mitral valve leaflets have been captured and clamped together.

Fig. 5C is a cross-sectional view similar to fig. 5A and 5B, but showing the frame of the selective occlusion device implanted and attached to the clip structure, with the flexible membrane removed for clarity.

Fig. 5D is a view similar to fig. 5C but showing the flexible membrane of the device in place on the frame structure.

Fig. 6A is a perspective view of the frame structure and attached clip structure shown in fig. 5A-5C.

Fig. 6B is a perspective view similar to fig. 6A, but showing another embodiment of collapsible and expandable frame structure.

Fig. 7A is a cross-sectional view of the native mitral valve and selective occlusion device of fig. 6B with the heart in diastole.

Fig. 7B is a cross-sectional view similar to fig. 7A, but showing the selective occlusion device and mitral valve when the heart is in a systolic phase.

Fig. 8 is a side view and cross-section of the heart at the location of the native mitral valve, showing the selective occlusion device of fig. 7A and 7B, with the membrane shown in phantom lines for clarity and implanted.

Fig. 9 is a perspective view showing another embodiment of a selective occlusion device, with the frame structure shown in solid lines and the flexible membrane shown in phantom lines for clarity.

Fig. 10A is a schematic perspective view similar to fig. 1A and 5A, but showing another embodiment of a catheter-based system for delivering and implanting a selective occlusion device coupled to a pre-installed mitral valve She Gazi structure.

Fig. 10B is a view similar to fig. 10A, but showing a subsequent step during the method.

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

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

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

Fig. 11C is a front top perspective view of the device of fig. 11A or 11B implanted in a native mitral valve.

Fig. 11D is a front view of the device of fig. 11A to 11C.

Fig. 11E is a transverse cross-section of fig. 11D.

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

Fig. 12B is a cross-sectional view of the heart taken at the native mitral valve and showing the selective occlusion device of fig. 12A in a side view.

Fig. 12C is a view similar to fig. 12B, but showing another alternative embodiment of a selective occlusion device implanted in a native mitral valve.

Fig. 12D is another view similar to fig. 12C, but showing another alternative embodiment of a selective occlusion device implanted in a native mitral valve.

Fig. 13A is a cross-sectional view taken through the mitral valve and generally through one of the selective occlusion elements of fig. 12A-12D to illustrate the seal during systole.

Fig. 13B is a view similar to fig. 13A, but showing the selective occlusion element and mitral valve when the heart is in diastole.

Fig. 13C is a view similar to fig. 13B, but showing another embodiment of a selective occlusion element.

Fig. 14A is a perspective view of another alternative embodiment of a selective occlusion device and mitral valve clip structure.

Fig. 14B is a perspective view of another alternative embodiment of a selective occlusion device and mitral valve clip structure.

Fig. 14C is a perspective view of another alternative embodiment of a selective occlusion device and mitral valve clip structure.

Fig. 15A is a perspective view of another alternative embodiment of a selective occlusion device with the flexible membrane broken away for clarity.

Fig. 15B is a perspective view similar to fig. 15A but further illustrating the flexible membrane on the frame structure.

Fig. 15C is a side view of the selective occlusion device of fig. 15A and 15B with the flexible membrane removed for clarity.

Fig. 15D is a side view similar to fig. 15C but showing the flexible membrane applied to the frame structure.

Fig. 15E is a top view of the device shown in fig. 15A-15D, but showing a cross-section of the membrane to show the shape of the membrane in an expanded or filled state when the heart is in a systolic phase.

Fig. 16A is a perspective view of a system and heart, similar to fig. 5A, but showing another alternative embodiment of a catheter-based system and method for implanting a selective occlusion device and clip structure into a native mitral valve.

Fig. 16B is a perspective view similar to fig. 16A, but showing a subsequent step in the method.

Fig. 16C is a view similar to fig. 16B, but showing another subsequent step in the method.

Fig. 16D is a perspective view illustrating an implanted selective occlusion device in a mitral valve of a patient.

Fig. 17A is a side cross-sectional view of the native mitral valve and the selective occlusion device of fig. 16A-16D implanted and secured to a mitral valve clip structure.

Fig. 17B is a side cross-sectional view similar to fig. 17A, but showing a subsequent step in the method.

Fig. 17C is a side cross-sectional view similar to fig. 17B, but showing another subsequent step in the method in which the device is fully implanted.

Fig. 18A is a cross-sectional view of the selective occlusion device as shown in fig. 16A-16D and 17A-17C, and showing the device and mitral valve when the heart is in diastole.

Fig. 18B is a view similar to fig. 18A, but showing the device and native mitral valve when the heart is in a systolic phase.

Fig. 19 is a top view schematically illustrating a representation of the shape of the selective occlusion device when implanted into a native mitral valve having anatomical curvature.

Fig. 20 is a perspective view of a selective occlusion device constructed in accordance with another alternative embodiment.

Fig. 21A is a side cross-sectional view taken generally along the length of the central portion of the device shown in fig. 20.

Fig. 21B is a top view of the device shown in fig. 21A.

Fig. 21C is a cross-sectional view of the device shown in fig. 21B.

Fig. 22A is a perspective view of a catheter-based system and method according to another alternative embodiment implemented on a native mitral valve, shown partially in schematic cross-section of the heart.

Fig. 22B is a view similar to fig. 22A, but showing a subsequent step in the method.

Fig. 22C is a view similar to fig. 22B, but showing another subsequent step in the method.

Fig. 22D is a perspective view showing the fully implanted device in the native mitral valve, resulting from the method shown in fig. 22A-22C.

Fig. 22E is a view similar to fig. 22D, but showing an alternative frame structure attached to the selective occlusion device.

Fig. 22F is a view similar to fig. 22E, but showing another alternative frame structure.

Fig. 22G is a view similar to fig. 22F, but showing another alternative frame structure.

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.

Fig. 23B is a view similar to fig. 23A, but showing the device and mitral valve when the heart is in diastole.

Fig. 24 is a side cross-sectional view of another alternative embodiment of a heart valve repair device implanted into a native mitral valve.

Fig. 25A is a cross-sectional view of another alternative embodiment of a heart valve repair device.

Fig. 25B is a cross-sectional view of another alternative embodiment of a heart valve repair device implanted into a native mitral valve.

Fig. 26A is another alternative embodiment of a selective occlusion device shown in cross-section.

Fig. 26B is a schematic diagram illustrating implantation of the device of fig. 26A into a native mitral valve.

Fig. 26C is a perspective view showing the implantation of the device of fig. 26A and 26B into a native mitral valve.

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

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

Fig. 27A is a perspective view of another alternative selective occlusion device.

Fig. 27B is a longitudinal cross-sectional view of the device shown in fig. 27A, schematically illustrating blood flow during systole of the heart.

Fig. 27C is a cross-sectional view showing the device of fig. 27A and 27B during systole.

Fig. 28A is a perspective view illustrating another alternative embodiment of another apparatus including a selective occlusion device and a mitral valve clip structure.

Fig. 28B is a lengthwise cross-sectional view showing the device and clip structure shown in fig. 28A.

Fig. 28C is a cross-sectional view showing the device of fig. 28A and 28B.

Fig. 29A is a cross-sectional view of the selective occlusion device and clip structure, schematically illustrating blood flow between intimal wall surfaces during systole.

Fig. 29B is a cross-sectional view of the device of fig. 29A implanted in a native mitral valve, and showing the apparatus and mitral valve when the heart is in a systolic phase.

Fig. 30 is a perspective view showing a cross section of the mitral valve and a fully implanted selective occlusion device and clip structure.

Fig. 31 is a perspective view showing another alternative embodiment of a prosthetic heart valve and valve She Gazi structure.

Fig. 32A is a side view, partially broken away, to show the prosthetic heart valve and valve She Gazi structure.

Fig. 32B is a cross-sectional side view of a native heart valve showing an initial portion of an implantation procedure associated with the prosthetic heart valve of fig. 31 and 32A.

Fig. 32C is a view similar to fig. 32B, but showing a subsequent step in the method.

Fig. 32D is a view similar to fig. 32C, but showing a subsequent step in the method.

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 deployed into an implanted state.

Fig. 33 is a perspective view of another alternative embodiment of a prosthetic heart valve and native valve She Gazi structure.

Fig. 34A is a side view of the prosthetic heart valve shown in fig. 33.

Fig. 34B is a view of the prosthetic heart valve of fig. 34A implanted into a native heart valve.

Fig. 35A is a cross-sectional view similar to fig. 29B, but showing another exemplary embodiment of a heart valve repair device implanted into the mitral valve, and showing a systolic phase of the cardiac cycle.

Fig. 35B is a cross-sectional view similar to fig. 35A, but showing the device and mitral valve when the cardiac cycle is in the diastolic phase.

Fig. 36A and 36B are illustrations of the anatomy of the native mitral valve and the native tricuspid valve, respectively.

Fig. 37A is a schematic view of a native mitral valve.

Fig. 37B-37D are schematic views of a native mitral valve after a clamping operation in which one or more clips engage a native leaflet.

Fig. 38A-38F are schematic views of a natural tricuspid valve after a clamping operation in which one or more clips are engaged with the natural leaflet.

39A and 39B are schematic diagrams of side and top views, respectively, of a prosthetic valve according to an embodiment.

Fig. 40A and 40B are schematic views of the prosthetic valve of fig. 39A and 39B, shown in side and top views, respectively, disposed in a native mitral valve.

Fig. 41 is a flowchart of a method of delivering the prosthetic valve of fig. 39A and 39B, according to an embodiment.

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

Fig. 42C is a perspective view of the prosthetic valve of fig. 42A and 42B shown disposed in a native mitral valve.

Fig. 42D-42F are partial end cross-sectional views showing variations of clip connectors of the prosthetic valves of fig. 42A-42C.

Fig. 43 is a partial cross-sectional side view of a prosthetic valve according to an embodiment.

Fig. 44 is a partial cross-sectional side view of a prosthetic valve according to an embodiment.

45A-45C are partial cross-sectional side views of a prosthetic valve showing a process for expanding the prosthetic valve flap, according to an embodiment.

Fig. 46A-46C are top, side and partial cross-sectional side views, respectively, of a prosthetic valve according to one embodiment.

Fig. 47A-47D are top, side, end and exploded end views of a prosthetic valve disposed in a native mitral valve according to one embodiment.

Fig. 48 is a top of a flow control device similar to the prosthetic valve of fig. 47A-47D, according to an embodiment.

Fig. 49A and 49B are top and side views, respectively, of a prosthetic valve according to an embodiment.

Fig. 50 is a side view of a prosthetic valve according to an embodiment.

51A and 51B are top and partial cross-sectional end views, respectively, of a prosthetic valve according to one embodiment.

51C-51F are perspective views of components of a flow control device of the prosthetic valve of FIGS. 51A and 51B.

Fig. 52A and 52B are schematic diagrams of side and top views, respectively, of a prosthetic valve according to an embodiment.

Fig. 53A and 53B are schematic illustrations of the prosthetic valve of fig. 52A and 52B, shown disposed in a native mitral valve in side and top views, respectively.

Fig. 54 is a flowchart of a method of delivering the prosthetic valve of fig. 52A and 52B, according to an embodiment.

Fig. 55A-55C are side, top and top perspective views of a prosthetic valve disposed in a centrally-clamped mitral valve, according to an embodiment.

Fig. 56A and 56B are top views of a prosthetic valve disposed in a centrally-clamped mitral valve, and fig. 56C-56I illustrate a mechanism and process for securing the prosthetic valve to a clip in the mitral valve, according to one embodiment.

FIGS. 57A and 57B are top and end views, respectively, of a prosthetic valve according to one embodiment, shown disposed in an eccentrically clamped mitral valve.

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

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

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

FIGS. 60C and 60D are perspective top views of the prosthetic valve of FIGS. 60A and 60B, showing an alternative heart tissue tether.

Fig. 61A is a top view of a prosthetic valve, showing it disposed in an eccentrically clamped mitral valve, and fig. 61B is a top perspective view of the clip of fig. 61A, according to one embodiment.

FIG. 62 is a top view of a prosthetic valve according to one embodiment, shown disposed in a mitral valve clamped with two eccentrically positioned clamps.

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 process.

Fig. 64A and 64B are top and top perspective views, respectively, of a prosthetic valve according to one embodiment, as shown in fig. 64A, disposed in a tricuspid valve that is clamped with three clamps.

Fig. 65A is a cross-sectional perspective view of a delivery system for the clip and prosthetic valve of fig. 64A and 64B, and fig. 65B-65D illustrate delivery of the clip to the tricuspid valve, resulting in the clipped tricuspid valve shown in fig. 64A.

FIG. 66 is a top view of a prosthetic valve showing placement in the tricuspid valve clamped by three clamps during mitral valve angioplasty, according to one embodiment.

Fig. 67A-67C illustrate a cardiac tissue tether for a clip and a procedure for delivering and deploying the tether and clip.

Detailed Description

The detailed description herein is intended to describe non-limiting implementations or embodiments related to various inventive concepts and uses reference numerals to facilitate understanding of these embodiments. As will be appreciated, common reference numerals between the drawings refer to common features and structures having the same or similar functions. While the various figures will have common reference numerals referring to such common features and structures, for the sake of brevity, the following description of the figures will not necessarily repeat the discussion of such features and structures.

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. Tricuspid valve 18 is also shown in communication with right ventricle 19. The mitral valve 16 includes anterior leaflet 16a, posterior leaflet 16b, and native valve annulus 16c. When the mitral valve 16 is operating normally, 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 systole, the anterior and posterior native mitral valve leaflets 16a, 16b will fully coapt or coapt against each other to prevent any reverse flow of blood from entering the left atrium 12, and blood in the left ventricle 14 will be effectively ejected and pass completely through the aortic valve (not shown). The catheter 20 carries a collapsed selective occlusion device 22 along a guidewire 24. In this exemplary procedure, catheter 20 is delivered through peptide across atrial septum 12 a. It should be understood that any other transcatheter approach or other surgical approach with varying degrees of invasiveness may alternatively be used. The patient may or may not bypass during the procedure and the heart may or may not beat. As further shown in fig. 1A, the native mitral valve leaflets 16a, 16b are supported by chordae tendineae 26 that attach to papillary muscles 28. As schematically shown in fig. 1A, the anterior and posterior native mitral valve leaflets 16a, 16b may not properly coapt or engage each other when the cardiac cycle is in systole. Insufficient coaptation of the leaflets 16a, 16b can result in blood flowing back or regurgitation from the left ventricle 14, through the mitral valve 16 into the left atrium 12, and not entirely through the aortic valve (not shown).

Referring now to fig. 1A in conjunction with fig. 1B and 1C, the selective occlusion device 22 has been fully extruded or extended from the distal end 20a of the catheter 20 and transitioned from the collapsed position or state within the catheter 20 shown in fig. 1A to the expanded state shown in fig. 1B and 1C. As further shown in fig. 1B and 1C, the selective occlusion device 22 includes a collapsible and expandable 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 16 c. The selective occlusion device 22 is formed in a manner that allows it to collapse as shown in fig. 1A for delivery but to expand into the exemplary form shown in fig. 1B and 1C. This can be achieved in a number of ways. For example, the frame structure 30 may be constructed of a flexible polymer, such as a superelastic metal or shape memory metal or other material. The selective occlusion device 22 may be deployed into a preformed shape, for example, by using a shape memory material. The frame structure 30 may be partially or fully covered by a fabric such as Dacron, teflon and/or other covering materials such as those used in the manufacture of prosthetic heart valves or other implants. More specifically, the frame structure 30 includes a curved frame member 32, and in this and/or other embodiments, the curved frame member 32 extends from one commissure to another commissure. The frame member 32 may alternatively extend from other portions of the heart tissue generally at the annulus region. At opposite ends, the frame structure 30 is supported by respective first and second non-penetrating valve ring connectors 34, 36. As an example of non-penetrating valve ring connectors, these connectors are configured with respective upper 34a, 34b and lower 36a, 36b connector elements. 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 shown as "butterfly" connectors, respectively, that can be slid or inserted in place with native leaflet tissue sandwiched or secured therebetween. It will be appreciated that other tissue capturing connectors, and/or other penetrating or non-penetrating connectors may alternatively be used. Non-penetrating connectors are advantageous because they do not cause damage due to penetrating the connector and they allow for positional adjustment. The frame structure 30 further includes first and second membrane support members 38, 40 at opposite ends, the first and second membrane support members 38, 40 configured to be positioned in the left ventricle 14 to support the flexible membrane 44 in a slightly open state. The flexible membrane 44 forms, with the frame structure 30, a selective occlusion device that cooperates with the native mitral valve leaflets 16a, 16b to control blood flow through the mitral valve 16. The flexible membrane 44, which in this embodiment is used as a prosthetic heart valve, is moved by movement in conjunction with the leaflets 16a, 16b, as described below. In other embodiments, the selective occlusion device need not have any moving parts that move with the leaflets 16a, 16 b. 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 by adhesives, mechanical fastening, stitching, fasteners, and the like. As further shown, a substantial portion at the lower edge of the flexible membrane 44 is unattached to the frame structure 30. The membrane support members 38, 40 are short, curved members and the remaining membrane portion at the lower edge of the flexible membrane 44 is not directly attached to any frame portion. This allows the flexible membrane to bulge, expand or distend outwardly to engage the native leaflets 16a, 16b during systole, and to prevent blood flow back through the mitral valve 16 in the opposite direction when the cardiac cycle is in systole, as discussed further below.

The flexible membrane 44 may be formed of various types of thin flexible materials. For example, the material may be a natural, synthetic or bioengineered material. The material may include valve tissue or pericardial tissue from animals (e.g., bovine and porcine) or other sources. The flexible membrane 44 may be constructed using a synthetic material or combination of materials such as ePTFE, dacron, teflon or other materials. The flexibility of the frame structure 30, along with the flexibility of the flexible membrane 44, provide conditions for the operation of the selective occlusion device 22, as well as the manner contemplated herein, and may also help prevent failure due to fatigue caused by repeated cycling of the selective occlusion device 22 in the heart 10. It should be appreciated that fig. 1B shows the flexible membrane 44 removed to clearly see the frame structure 30, and that in this figure the flexible membrane 44 is shown in phantom, while in fig. 1C the flexible membrane 44 is shown in solid, with the cardiac cycle in systole, and the flexible membrane 44 fully engaging the native leaflets 16a, 16B to reduce regurgitation of blood flow through the mitral valve 16. The flexible membrane 44 may be sutured to the frame structure 30 using techniques employed by the prosthetic heart valve industry for manufacturing prosthetic aortic and mitral valves. The frame may be made of one or more layers of material, such as superelastic or shape memory material, and the membrane 44 may be suitably secured. One way may be to capture the flexible membrane 44 between the layers of the frame structure 30. To hold the membrane 44 in place, a fabric cover (not shown) attached to the metal frame may help attach the membrane 44 to the frame structure 30.

Fig. 2A, 2B and 2C are cross-sections through the selective occlusion device 22 and mitral valve 16 shown in fig. 1A-1C. Fig. 2A shows the device 22 in cross-section along line 2A-2A of fig. 3A, while fig. 2B shows the selective occlusion device 22 in cross-section along line 2B-2B of fig. 3A, both of which show the cardiac cycle in systole. Fig. 3A and 3B are top views showing the contracted and relaxed states, respectively, but do not show a hinge 32a that may be provided to assist in folding during delivery. Fig. 2C is similar to fig. 2B, but shows the selective occlusion device 22 when the cardiac cycle is in diastole. During systole (fig. 2A, 2B and 3A), which means that when the native mitral valve 16 is assumed to be fully closed to prevent blood from flowing back into the left atrium 12, pressurized blood will flow through the open end 45 of the flexible membrane and at least to any substantial extent through the closed end 47. It will be appreciated from a review of some embodiments that small vents may be provided in the flexible membrane. Because the flexible membrane bulges or expands outwardly in the direction of the arrows shown in fig. 2B, the native mitral valve leaflets 16a, 16B will seal against the flexible membrane 44 or close with the flexible membrane 44 to prevent backflow of blood flow. In this way, the mitral valve leaflets 16a, 16b, which would otherwise not properly seal together or close, 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 contact the native leaflets 16a, 16 b. In other words, only a portion of the lower edge of the flexible membrane 44 is attached to the frame structure 30. As further shown in fig. 2B, additional membrane material may be present near the membrane support members 38, 40 to allow for an expanded membrane condition. As further shown in fig. 2C and 3B, when the cardiac cycle is in diastole and blood flow is desired 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 when the native mitral valve leaflets 16a, 16B move apart or away from each other in opposite directions to facilitate blood flow in the direction of the arrows, the flexible membrane 44 will enter a collapsed or contracted state. The arched membrane support members 38, 40 maintain a spacing between the lower edges or rims of the flexible membrane 44 to force blood through the open end 45 into or within the membrane 44 during contraction, causing the membrane 44 to expand or bulge outwardly such that the membrane 44 fills the gap between the native mitral valve leaflets 16a, 16 b. The arched or curved support members 38, 40 and/or other portions of the frame structure 30 may be formed using a central wire and a fabric covering around the wire. Other constructions are possible, such as the use of soft sponge-like materials, as well as the use of fabrics in combination with more structurally supportive materials (e.g., metals and/or plastics). Filling and emptying of the flexible membrane 44 through the open end 45 ensures that the bottom surface of the membrane 44 is cleaned or rinsed at each heartbeat to prevent clot formation and any embolism of clot material.

Fig. 4A and 4B are similar to fig. 1B and 1C, respectively, but show the selective occlusion device 22 isolated from the native mitral valve 16 (fig. 1B and 1C).

Fig. 5A-5D illustrate another embodiment of a selective occlusion device 22 a. As previously mentioned, all like reference numerals between the various embodiments and the figures represent like structures and functions except for the scope described herein. Some reference numerals will have suffix modifications, such as a letter (e.g., "22 a") or an apostrophe (e.g., 90'), indicating modifications to similar structures, which will be discussed and/or apparent from a review of the drawings. For the sake of brevity, similar structures and functions between the various drawings are not redundantly described or reduced to a minimum. This embodiment is particularly suitable for achieving those benefits relating to mitral valve repair in which one native leaflet edge is clamped or otherwise secured to another. However, it should be understood that a clip or other anchor (collectively referred to herein as a clip structure) can be applied to only one leaflet edge, and that more than one clip or anchor can be used. Typically, mitral valve repair is performed with a clip structure 50 having first and second clip elements 50a, 50b, which are movable toward each other from an open state to a closed position. The clip structure 50 is typically applied during transcatheter procedures using a suitable catheter assembly 52. In these figures, a representative and exemplary clip structure 50 is shown for clipping together the edges of the native leaflets 16a, 16b near the center of each edge. The beginning of this procedure is shown in fig. 5A, where catheter assembly 52 is transseptally directed through atrial septum 12a into left atrium 12, into mitral valve 16, and to left ventricle 14. A portion of the edge of each leaflet 16a, 16B is captured by the clip structure 50 and then secured by the clip and firmly together as shown in fig. 5B. At least one of the elements 50a, 50b moves towards the other in a clamping or pinching action to change from an open to a closed state. A wire, suture or other tensioning member or connector 54 is coupled to the clip structure 50. At or near the end of the clamping step of the method, a selective occlusion device 22a (fig. 5D) in the form of a frame structure 30a and a flexible membrane 44a is introduced through the catheter 52 in a manner similar to the method described above with respect to the first embodiment. The selective occlusion device 22a is guided by a suture, wire or other tensioning member 54 attached to the clip structure 50 and extending from the clip structure 50.

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 devices 30a,44a in place and implant as a selective occlusion device 22a in the native mitral valve 16. The two portions 60, 62 are employed in the manner described above in connection with the single-portion embodiment of the device 30, 44. As can be appreciated from a review of fig. 5C and 5D, the modified frame structure 30a is employed to support the modified flexible membrane 44a. More specifically, flexible membrane 44a includes corresponding portions 44a1 and 44a2. These may be formed from one or more different sheets of film material. In addition, the third and fourth membrane support members 64, 66 are provided to support the flexible membrane portions 44a1 and 44a2 in a similar and analogous manner to the support members 38, 40 in the first exemplary embodiment described above. An arcuate frame member 32 is shown that spans across the native valve 16, similar to the first embodiment. Vertical support members 65, 67 extend from the frame member 32 and are coupled with the membrane support members 64, 66. Alternatively, the frame members 32 may be omitted and the vertical members 65, 67 or other structures may be joined together in a central region of the device 22a.

As further best shown in fig. 5C, the suture or wire 54 couples the clip structure 52 to the frame structure 30a, for example, through the use of a crimping element or other fastener 68 generally at the hinge 32 a. It will be appreciated that other securing methods and structures may alternatively be used to secure the clip structure 50 to the frame structure 30a. The clip structure 50 and the frame structure 30a may take forms other than the exemplary forms shown and described herein. In addition to non-penetrating and/or other connectors, such as generally at the native annulus 16c, the use of a clip structure 50 that secures the frame structure 30a provides a generally secure implant. The clip structure 50 and the one or more annulus connectors will provide opposing forces that firmly secure 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 44a1, 44a2 are separated from each other by a clip structure 50. The attachment of the selective occlusion device 22a to the native mitral valve 16 may be a direct connection between the flexible membrane 44a and the native leaflets 16a, 16b (see below). Alternatively, instead of a single gantry member 32, the two side-by-side portions 60, 62 of the frame structure 30a may be otherwise coupled together near the center of the selective occlusion device 22a to avoid the need for a continuous frame member 32 across the native mitral valve 16. Further modifications may be made while retaining the advantages of the clip structure used in conjunction with the selective occlusion device. For example, the selective occlusion device may be configured as a frame structure, and the flexible membrane is affixed around a continuous peripheral portion of the frame structure.

Fig. 6A and 6B illustrate additional embodiments of selective occlusion devices 22B and 22c. In these figures, the flexible membrane 44a is shown in phantom, thereby more clearly showing the respective frame structures 30b, 30c. In the exemplary embodiment of fig. 6A, the central hinge is eliminated and the suture or wire 54 extends directly through the frame member 32. As with all embodiments, the devices 22b, 22c and any associated components, such as the frame structures 30b, 30c, may be made sufficiently flexible and collapsible for catheter delivery purposes. Likewise, a crimping element (not shown) or any other securing means may be used to stretch secure the wire or suture 54 against the frame structures 30b, 30c. Fig. 6B illustrates an embodiment of the selective occlusion device 22c that differs slightly from the embodiment of fig. 6A in that the flexible membrane 44a, shown in phantom, is folded inwardly at the region of the clip structure 50. As shown in fig. 6A, and as an alternative, the flexible membrane 44a may be more clearly attached to the frame members, as shown by the dashed lines extending upwardly against the vertical frame members 65, 67.

Fig. 7A and 7B are top views showing a selective occlusion device 22c, such as shown in fig. 6B, having separate portions 44a1 and 44a2 secured in place and implanted within the native mitral valve 16. Fig. 7A shows the selective occlusion device 22c when the cardiac cycle is in diastole, while fig. 7B shows the selective occlusion device 22c when the cardiac cycle is in systole. The function of a multi-segment device such as with the devices 22a, 22B, 22c is similar to that 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 into two parts by the clip structure 50, the separate flexible membrane portions 44a1 and 44a2 independently function to contract or collapse during diastole (fig. 7A), and bulge, expand or dilate outward during systole (fig. 7B) as a result of forced blood flow introduction while the cardiac cycle is in systole. This effect or result is similar to that described above in connection with, for example, fig. 3A and 3B, but has 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 manner, as shown in fig. 7A, blood is allowed to flow through the native mitral valve leaflets 16a, 16b during diastole, which native mitral valve leaflets 16a, 16b spread or unfold outwardly, and also past the two-part flexible membrane 44a that collapses inwardly or away from the native mitral valve leaflets 16a, 16 b. During contraction, as the flexible membrane 44a expands or swells to contact or engage the native mitral valve leaflets 16a, 16b to form a fluid seal, the reverse or regurgitant blood flow is at least reduced, if not reduced to substantially zero (prevented).

Fig. 8 shows a side view of the selective occlusion device 22c shown in fig. 7B, but for clarity, the flexible membrane 44a is shown in phantom. The selective occlusion device 22c is securely implanted in the mitral valve 16 between the generally superior annulus connectors 34, 36 and the clip structure 50 in the inferior position. Likewise, different connector and/or clip configurations than those shown and described may be used, and a different number of connector and clip configurations may be used. The clip structure can be secured to each leaflet 16a, 16b simultaneously, as shown, or can be secured to a single leaflet 16a and/or 16b, respectively. Although the tensile member 54 is shown as having a particular length of connection between the clip structure 50 and the frame member 32, tensile members or other types of connection to any necessary greater or lesser extent may alternatively be used. In some cases, the clip structure 50 may be directly attached to the frame structure 30.

Fig. 9 illustrates a selective occlusion device 22d constructed in accordance with an exemplary embodiment, wherein an alternative configuration of the frame structure 30d is used and coupled with a flexible membrane 44 (shown in phantom for clarity). In particular, 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 firmly 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. Allowing the lower edge of the flexible membrane 44 to bulge or expand outwardly and may be separated from the lower support members 70, 72, 74, 76 along at least a substantial portion to allow such expansion or bulging action 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 deployment or bulging actions to occur when the cardiac cycle is in a contracted state as previously described.

Fig. 10A, 10B and 10C illustrate another exemplary embodiment in which a transcatheter system 52 is used, and in particular, a clip structure capture device 80 is used to help secure the selective occlusion device 22a in place. This may be particularly useful when applying a selective occlusion device, such as in accordance with the present disclosure, to a previously implanted mitral valve clip structure 50. Clip structure 50 may 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 mitral valve function deteriorates over time despite the clip repair procedure, this embodiment helps capture the previously implanted clip structure 50 and implant the selective occlusion device, such as the frame structure 30a and flexible membrane 44a. In this regard, and as shown in fig. 10A and 10B, a lasso or suture loop device 81 is deployed from a catheter 82 and captures the clip structure 50 with the aid of a guide 83. Sutures, wires, or other tensioning members 54 extending up through the mitral valve 16 may be part of a suture loop apparatus 81 in this embodiment, and may 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 clarity, flexible membrane 44a is not shown in fig. 10C.

Fig. 11A and 11B illustrate two additional embodiments of selective occlusion devices 22e, 22f, not shown are flexible membranes that may be used to prevent backflow of blood through a heart valve, such as through mitral valve 16. In these embodiments, the flexible membrane 44a (fig. 11C-11E) may be fixedly attached to the frame structure 90, 90' from one end to the other, such as between two non-penetrating annular connectors, or in other embodiments, between penetrating connector portions 92, 94, 92', 94 '. Advantageously, there are two spaced apart elongate frame members 96, 98 extending between the connectors 92, 94, 92', 94', each having an upwardly curved or raised portion 100, 102, thereby forming a recessed space. As shown in fig. 11C, the flexible membrane 44a is carried on the frame structure 90, 90' and may 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 may leave a desired portion of the flexible membrane 44a at the lower edge of the unfixed frame structure 90, 90' and be able to expand or bulge in an outward direction during shrinkage. This outward deployment or bulging action will allow the flexible membrane 44a to better contact or engage the native leaflet tissue during systole to prevent regurgitation of blood flow. This will also allow more blood to exchange under or within the flexible membrane to prevent stagnation of blood and the resultant potential for embolism and clotting leading to stroke or other complications. The bosses 100, 102 in each lower spaced support member 96, 98 accommodate the clip structure 50 and generally receive portions of the mitral valve 16 that are 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 a wire, suture or other tensioning member 54 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 the mitral valve 16 and through the mitral valve 16 in a manner similar to the frame member 32. Suitable configurations of the frame structures 90, 90' may be used, such as any of those previously described, for receiving 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 also illustrate another way of attaching the frame structure, typically with one or more holes 106, 108, 110, 112 at the native annulus 16c, to engage with a suitable fixation element or anchor 114 (fig. 11D). The embodiment of fig. 11D includes two additional securing holes 116, 118 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 fixation element may be used, although the benefits of a non-penetrating connector according to the present disclosure would be desirable, such as for purposes of allowing self-adjustment and reducing tissue damage.

Fig. 12A and 12B illustrate another exemplary embodiment of a selective occlusion device 22 g. The device includes at least one rigid 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, the mitral valve leaflets 16a, 16b having been attached together at a central location along their edges with a clip structure 50 (e.g., the clip structure previously described). Thus, for reasons similar to the two-part flexible film embodiments described herein, two selective occlusion elements 120 are provided. The selective occlusion elements 120 are "rigid" when used within the mitral valve 16 because they are static and do not need to flex inward or outward to engage and disengage the native mitral valve leaflets 16a, 16b during the systolic and diastolic portions of the cardiac cycle. Instead, these disk-like elements 120 retain their shape and are sized and located in the native mitral valve 16 such that the native mitral valve leaflets 16a, 16b engage the elements 120 during systole and disengage the elements 120 during diastole. This selective or periodic interaction is illustrated in fig. 13A and 13B, which will be described further below. The device 22g shown in fig. 12A and 12B includes a frame structure 30e configured to extend generally across the native mitral valve 16, having a frame member 32 and a hinge 32A, as generally described in the previous embodiments, and non-penetrating annular connectors 34, 36, as previously described. Further, the clip structure 50 is secured to the frame structure 30e with the crimping element 68 and a suture, wire or other tensile member 54, such as by one of the foregoing. In this manner, first and second rigid selective occlusion elements 120 are provided on opposite sides of the native mitral valve 16 and on opposite sides of the clip structure 50, respectively, to selectively include openings formed in the native mitral valve 16 when the clip structure 50 is attached to each leaflet 16a, 16b such that central portions of the two leaflet edges are in direct contact with each other or with a spacer (not shown) provided between the movable clip elements. In this embodiment, the frame structure 30e is formed with a curved or arched frame member 32 configured to extend across the native mitral valve 16 in the left atrium 12.

The selective occlusion device 22g is shown in fig. 12A, 12B and 13A when the cardiac cycle is in systole. The native mitral anterior and posterior leaflets 16a, 16b are shown being urged inwardly toward each other. Because the static occlusion element 120 fills any residual gaps between the anterior and posterior leaflets 16a, 16b, there is no blood leakage or regurgitation. The element 120 need not have the shape depicted. If the gap between the two leaflets 16a, 16b is filled with elements 120, any shape of space filling is sufficient. The optimal shape may be determined, at least in part, by studying the shape of the gap between the systolic native mitral valve leaflets 16a, 16b after application of the clip structure 50. The optimal shape of the element 120 for a particular patient anatomy may even be custom manufactured for that patient by rapid manufacturing techniques. Advantages of using one or more rigid/static elements 120 include their ability to withstand repeated cyclic forces, perhaps better than designs that rely on one or more moving valve elements that may be more fatigued.

Fig. 12B shows a cross-sectional view of the mitral valve 16 from commissure to commissure more specifically. At the commissures, anchors or connectors 34, 36 are shown on each side above and below the leaflets 16a, 16 b. At the center, there is a clip structure 50 or other attachment that is anchored to the mitral valve leaflets 16a, 16b, either individually or together. A tensile or other connecting member 54 extends upwardly from clip attachment component 50 and attaches to frame member 32, with frame member 32 extending across valve 16 from commissure to commissure.

The frame structure 30e may be constructed of a metallic material such as stainless steel or nitinol. Nitinol or other shape memory or superelastic material may be preferred because it can be collapsed for delivery through a catheter device inside the heart and then deployed inside the heart for implantation.

The element 120 may be configured in a variety of ways and have a variety of shapes. They may be composed of a metal frame (e.g., nitinol) that can collapse for catheter delivery. The metal frame may be covered with a plastic material or other artificial material such as silicone or teflon or polyurethane. The pericardium of an animal or human, or heart valve material of an animal or human, or any material commonly used for heart valve leaflet construction, may be used to cover the frame structure 30e. Synthetic or bioengineered materials can also be used to cover the frame structure 30e.

The interior of the static occlusion element 120 may be hollow. Alternatively, a bladder or bladder may be positioned internally to fill the hollow interior space of element 120. The bladder may be filled with air or any gas or liquid, such as saline, sterile water, blood, antibiotics or sterilizing fluid, polymers or curable fluid materials. Filling the interior of the element 120 with a bladder may eliminate or reduce the need for a frame associated with the element 120.

The selective occlusion device 22g has commissures and leaflet attachments to anchor it in place. The device may also be created without leaflet attachment. For example, the accessory can only be at the commissure. It is not necessary to have the clip structure 50 and the members connected to the frame member 32. In this case, two occlusion elements 120 are not required. A single occlusion element 120 can be used to fill any gap between the two leaflets 16a, 16 b. Of course, the shape may vary—it may be an elliptical surface extending between the commissures. The frame of such elements may be similar to the frame or another configuration previously shown or described in connection with the first embodiment.

Fig. 12C illustrates another exemplary embodiment or variation of a selective occlusion device 22h mounted to a native mitral valve 16 inside a heart. There are two selective occlusion elements 120 attached to the frame structure 30f. The frame structure 30f engages the clip structure 50, which clip structure 50 attaches the anterior leaflet 16a and the posterior leaflet 16b together centrally, e.g., near the A2/P2 junction. The frame structure 30f is stabilized at the commissures of the valve 16 and at the annular region 16c by connectors 34, 36.

The embodiment of fig. 12C is similar to the embodiment shown in fig. 12A and 12B. The difference here is that the support frame member 32 is not located above the element 120, but below the element 120. In other embodiments, the support frame member 32 is positioned over the selective occlusion device and directed toward the left atrium. In this embodiment, the support frame member 32 is biased downward and toward the left ventricle, generally below the mitral valve 16. Further, in this embodiment, the frame member 32 can be directly connected to the clip structure 50 that attaches the two leaflets 16a, 16b and the frame structure 30f together. This may allow for a procedure in which the entire device is implanted at one time. The clip structure 50, along with the selective occlusion device element 120 coupled to the frame structure 30f, may be delivered by a catheter (not shown). The clip structure 50 (with or without the remainder of the exposure device) may be extruded within the heart 10 to the exterior of the delivery catheter. The clip structure 50 may then be closed over the anterior and posterior mitral valve leaflets 16a, 16 b. The remainder of the selective occlusion device 22h can then be released from the delivery catheter, thereby placing the entire device in place. This may simplify the process into one step.

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

Fig. 12D is a side view schematically illustrating another example embodiment of a selective occlusion device 22i, the selective occlusion device 22i including first and second rigid or static selective occlusion elements 120 coupled with a frame structure 30 g. In this embodiment, the rigid selective occlusion element 120 is directly coupled to the frame structure 30g, and the frame structure 30g may be the frame member 32 coupled to the clip structure 50. As in the previous embodiments, the clip structure 50 may directly couple the respective edges of the anterior and posterior mitral valve leaflets 16a, 16b, or may couple these leaflet edges together against an intermediate spacer (not shown). This may be used to properly orient and position the rigid selective occlusion element 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 central clip structure 50. Optionally, additional connectors 122, 124, shown in phantom, may be used to help secure the rigid selective occlusion element 120 in place at the commissures of the mitral valve 16.

Fig. 13A and 13B schematically illustrate in cross-section the function of the rigid selective occlusion element 120 shown in fig. 12A-12D. In particular, when the cardiac cycle is in systole, the native mitral valve leaflets 16a, 16b will abut against the rigid selective occlusion element 120 to provide a fluid seal against regurgitation of blood flow. As shown in fig. 13B, during diastole, the mitral valve leaflets 16a, 16B will fan 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 native leaflets 16a, 16B. One or more elements 120 fill any gaps between the anterior and posterior leaflets 16a, 16 b. When mitral insufficiency occurs due to failure to fully engage the leaflets, the leaflets 16a, 16b often pull away from each other in the plane of the valve 16 (here, side-to-side). However, as mitral regurgitation becomes more severe over time, the leaflets 16a, 16b tend to be pulled down into the ventricle 14 and separate from each other, which may become more complex. Thus, an up/down gap may also occur when one leaflet 16a or 16b is located in a higher plane than the other leaflet 16a, 16 b.

An advantage of the convexly curved outer surface of element 120 is that the surface can be shaped to accommodate a variety of imperfections that may occur between anterior leaflet 16a and posterior leaflet 16 b. The convex curved surface of element 120 may accommodate a leaflet gap that is in the plane of valve 16 (left and right in the drawing) and perpendicular to the plane of valve 16 (up and down in the drawing).

The selective occlusion device 22g is symmetrical on each side. The elements 120 may also be configured such that they are asymmetric, i.e. non-identical on opposite sides. For example, the posterior leaflet 16b may retract into the left ventricle 14 more than the anterior leaflet 16 a. It may be useful to make adjustments in the element 120 on the side facing the posterior leaflet 16b to fill the gap left by the retracted posterior leaflet 16 b. The element 120 can be configured to be more pronounced on a side of the element 120 adjacent to the posterior leaflet 16b than on a side adjacent to or facing the anterior leaflet 16 a. The shape of one or more of the elements 120 can be adjustable, such as by an adjustable inflation level or other method of the hollow interior of the element 120, to accommodate any need to fill the gap between the leaflets 16a, 16b that would otherwise result in regurgitation.

The custom or custom sized element 120 may also be made according to the shape of the gap. The gap may be determined by echocardiography or CT, and the appropriate size and shape of the filler element 120 may be selected based on measurements obtained by imaging. The shape of the valve defect to be repaired may be more like a cylinder and the cylinder or pyramid cylinder shape may better prevent blood flow back than the lens or disc shape of element 120.

The edge of the element 120 facing the forthcoming blood flow from the left atrium 12 has a tapered surface. This will allow blood to smoothly flow into the left ventricle and avoid blood damage or hemolysis and promote complete and unobstructed filling of the left ventricle 14. The edges of the element 120 inside the left ventricle 14 also exhibit a taper similar to the inflow region of the element 120. When the heart begins to contract, blood will be ejected back toward the element 120 and the native leaflets 16a, 16b will begin to move toward the element 120 to create a complete seal-preventing backflow of blood flow as the heart contracts.

Additional options are provided and are shown in fig. 13C. The rigid selective occlusion element 120 may be formed in a fluid efficient manner, such as a tear drop shape or other hemodynamic shape, to prevent undesired blood flow patterns and damage or hemolysis as blood flows through the element 120 between the element 120 and the respective mitral valve leaflets 16a and 16 b.

Fig. 14A, 14B and 14C illustrate further embodiments of selective occlusion devices 22j, 22k, 22l utilizing rigid or static selective occlusion elements 120. These elements 120 function as discussed above in connection with fig. 12A-12D and fig. 13A, 13B. In fig. 14A, a rigid or statically selective occlusion element 120 is coupled to a frame structure 30h that is fixed along the top edge of the element 120. At each end of the frame structure 30h, a respective commissure connector 126, 128 is provided, comprising a connecting element which operates in the same way as the butterfly element described before by sandwiching mitral valve tissue or other heart tissue therebetween. Additional securement is provided by clip structure 50 and a suitable tension element or other connector 54 such as previously described.

Fig. 14B shows an embodiment of the selective occlusion device 22k in the form of a rigid or static element 120, which rigid or static element 120 is again generally disc-shaped and secured together by a frame member 32', a tension element or connector 54, and a connected clip structure 50.

Fig. 14C shows an embodiment of the selective occlusion device 22l wherein the rigid selective occlusion elements 120 are secured together by a fabric or other structure 129 and further secured by a tensile member or other connector 54 to a clip structure 50 that secures the selective occlusion device 22l to the native mitral valve 16 by a clamping action as previously described.

Fig. 15A-15E illustrate another embodiment of a selective occlusion device 22m that includes a flexible membrane 44a and a frame structure 30i. The flexible membrane 44a is secured to the frame structure 30i, which frame structure 30i is also preferably flexible for reasons such as those previously described. This embodiment is similar to the previous embodiment utilizing a flexible membrane 44a in combination with the mitral valve clip structure 50, but includes a central reinforcing region, such as a fabric region 130, that allows for the direct clamping of native leaflet edge tissue onto the reinforcing fabric region 130. The clip structure 50 is shown in phantom in fig. 15E. In this alternative, the native mitral valve tissue does not directly contact the adjoining native mitral valve tissue, but contacts and secures against the reinforced central fabric region 130 of the flexible membrane 44 a. Such a fabric or other reinforcing material 130 may be useful, for example, where the remainder of the flexible film is formed of a more fragile material such as a biological material. As generally shown in the figures, the annulus connectors 132, 134 are provided and rest against the upper portion of the annulus 16c such that the clip structure 50 (not shown in this embodiment) secures the selective occlusion device 22m from below to the reinforced central region 130, and the annulus connectors 132, 134 secure the selective occlusion device 22m from above by resting against the native annulus 16c or otherwise coupling to the native annulus 16 c.

Fig. 16A-16D illustrate another exemplary embodiment of a transcatheter delivered selective occlusion device 22n in combination with a clip structure 50. Again, the clip structure 50 serves to affix the lower central edge portion of one leaflet 16a to the lower central edge portion of the opposite leaflet 16b, generally as described previously. Again, this clamping action may be to clamp the anterior leaflet 16a in direct contact with the posterior leaflet 16b at a central location, or to clamp the anterior and posterior leaflets 16a, 16b against an intermediate spacer. In this embodiment, the selective occlusion device is coupled to a clip structure 50 that is delivered through one or more catheters 52. As shown in fig. 16A and 16B, catheter assembly 52 is transseptally delivered into left atrium 12 and down through the native mitral valve, although other methods may alternatively be used in various embodiments. The clip structure 50 is extruded from the distal end of the catheter assembly and captures the leaflet edge portions as shown in fig. 16B in the open state shown in fig. 16A and is actuated to move one or both clip elements 50a, 50B together to the position shown in fig. 16C to secure the central leaflet edge portions together. The remainder of the selective occlusion device 22n is then extruded from the distal end of the catheter assembly 52, as shown in fig. 16C. As shown in fig. 16D, as an illustrative example, a selective occlusion device 22n, which may be of the type shown in fig. 16D or of any of the types additionally shown and described herein or even other configurations contemplated herein, self-deploys into the mitral valve location. Operation of the selective occlusion device 22n may be generally as described herein, and securement of the device 22n generally occurs between the clip structure 50 and the respective annulus connectors 132, 134. Specifically, as previously discussed, the annulus connectors 132, 134 provide a downward force for securing the device 22n generally at the annulus 16c, while the clip structure 50 provides an upward force that secures the selective occlusion device 22n generally in place in the native mitral valve 16 therebetween.

Fig. 17A-17C illustrate an embodiment of a device for transcatheter delivery and implantation. In this embodiment, the clip structure 50 is delivered to below the mitral valve 50 and the selective occlusion device 22n is delivered to a location above the native mitral valve 16, generally as described above. A selective occlusion device 22n is inserted into the mitral valve 16 and between the native leaflets 16a, 16B and also between the clip elements, as shown in the method of fig. 17A-17B. Once in place, as shown in fig. 17B, at least one clip element is moved toward the other clip element to clip or clamp the leaflet edges together, as previously described, and also to clip the lower central portion of the selective occlusion device 22n, and particularly in this embodiment the flexible membrane 44a, so that the leaflet edges are secured together while the selective occlusion device 22n is secured and implanted in place within the native mitral valve 16. As shown in fig. 17C, the selective occlusion device 22n is completely extruded from the catheter assembly, and then it self-expands to a position within the native mitral valve 16 and functions as generally discussed further herein. More particularly, fig. 18A and 18B show the diastolic and systolic portions, respectively, of the cardiac cycle with the device secured in place as described in connection with fig. 17A-17C. In fig. 18A, in diastole, blood flow is allowed between the native mitral valve leaflets 16a, 16b and the flexible membrane 44a, while in systole, the flexible membrane 44a is filled with blood in each portion and thereby expands or swells as the mitral valve leaflets 16a, 16b move toward each other and against the flexible membrane 44a to form a fluid seal, preventing backflow of blood from the left ventricle 14 into the left atrium 12 of the heart 10.

Fig. 19 is an anatomic view looking above the native mitral valve 16 with the selective occlusion device 22n superimposed to illustrate another representation of this configuration in which the selective occlusion device 22n is curved and flexed according to the natural curvature of the mitral valve 16.

Fig. 20, 21A, 21B and 21C illustrate another embodiment of the selective occlusion device 22o and apparatus (combining the device 22o with the clip structure 50), wherein the selective occlusion device 22o is generally configured as a two-segment device, but the segments are in fluid communication, as best shown in fig. 21A. The clip structure 50 is secured to the selective occlusion device 22o at a location between the respective open ends 140, 142 of the segments. The clip structure 50 is used in the same manner as previously described. The flexible membrane 44b is supported by a flexible but sturdy frame structure 143, which may be formed in any manner contemplated herein, for example, for allowing 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 in the systolic portion of the cardiac cycle and fluid communication between the two openings 140, 142, ensuring better flushing or purging during the cardiac cycle phase to reduce the chance of blood clotting.

Fig. 22A-22D illustrate another embodiment of an apparatus for transcatheter delivery and implantation of a clip structure 50 coupled to a selective occlusion device 22 p. The difference from this embodiment is that the clip structure 50 clips the native mitral valve leaflets 16a, 16b onto the central or intermediate spacer 150, rather than directly contacting each other. This procedure is generally shown in fig. 22A-22C, where the clip structure 50 is first extruded from the transseptally guided catheter assembly 52 at a location generally below the mitral valve leaflets 16a, 16 b. As shown in fig. 22B, the leaflets 16a, 16B are captured against the intermediate spacer 150. As shown in fig. 22C, the leaflets 16a, 16b are firmly secured 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 moves toward the central or intermediate spacer 150 to clamp 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 as shown in fig. 22C, and then the selective occlusion device 22p self-expands to the implanted condition shown in fig. 22D. It will be appreciated that the selective occlusion device 22p may be extruded and implanted as a separate component and may be coupled to the clip structure 50 in a suitable manner rather than being extruded in an assembled form from the catheter 52.

Fig. 22E shows another embodiment similar to that shown in fig. 22D, but further shows respective annulus connectors 154, 156 in the form of frame members as part of the selective occlusion device 22p that abut heart tissue generally at the annulus 16c in the left atrium 12, and additionally or alternatively frame members or connectors 158, 160 (shown in phantom) coupled with the selective occlusion device 22p and located in the left atrium 12 that abut the annulus 16c from below. The use of two sets of annulus connectors 154, 156, 158, 160 results in sandwiching cardiac tissue therebetween for better fixation.

Fig. 22F shows another embodiment of a device 22q, similar to fig. 22E, but showing a single annulus connector 164 formed as part of the selective occlusion device generally around the native mitral valve 16 and anchoring the selective occlusion device 22q securely in the native mitral valve 16, preventing wobble in any direction, but allowing flexibility. As with all embodiments, the frame members may be formed of any desired material, such as a flexible wire-like material formed of a polymer and/or a flexible metal including a superelastic or shape memory material. This may help achieve the general goal of embodiments for collapse delivery and improved flexibility of operation during use of the implant, as well as to resist failure due to fatigue in this application involving continuous cycling in the heart.

Fig. 22G shows another embodiment of the device 22 r. The selective occlusion device 22r may be as described in connection with any other embodiment, but for illustrative purposes is shown with a hollow flexible membrane 44b, while the frame structure has been modified as shown. The frame structure includes a generally annular frame member 170 such as that described and illustrated in connection with fig. 22F, but includes raised portions 170a, 170b relative to the other portions. The raised portions 170a, 170b are configured to be positioned near and above the commissures of the native mitral valve 16 and 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 forms part of the selective occlusion device 22 r. As with all embodiments, such frame members at the annulus may be above the annulus, below the annulus, or the frame members/connectors may be above and below the annulus to sandwich tissue therebetween.

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

Fig. 24 is a cross-sectional view schematically illustrating the mitral valve 16 and an implanted selective occlusion device 22s coupled with a central clip structure 50, such as at a coupling 183. The selective occlusion device 22s is of the type having a hollow interior 144 with two fluid communication 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.

Fig. 25A and 25B are schematic illustrations of a selective occlusion device 22t, 22t ' comprising a flexible membrane 44B, 44B ', fig. 25A and 25B showing the selective occlusion device 22t, 22t ' with the cardiac cycle in systole. The difference between the two 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 absent. The flexible membrane 44b and/or another portion of the device 22t, such as a frame portion, may additionally be coupled to the clip structure 50 in a manner such as that shown in fig. 24 or in another suitable manner.

Fig. 26A, 26B, and 26C schematically illustrate another example embodiment of an apparatus that includes a central clip structure 50 (fig. 26B) and a selective occlusion device 22u. The selective occlusion device 22u, as with the previous devices shown and described herein, is a hollow fluid communication structure having a flexible membrane 44B and allowing blood to flow into a hollow interior 144 defined by the flexible membrane 44B during systole, as shown in fig. 26B and 26C. During diastole, the flexible membrane 44b collapses inward, as previously shown and described, 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, 16 b. In this embodiment, the orientation of the openings 140, 142 and the shape of the device 22u force blood to flow toward the commissure regions during systole as indicated by the arrows. These forces also help to hold the device 22u in place in addition to any other securement such as the clip structure 50. In this way, wobble of the device 22u may be reduced and the device 22u may 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.

Fig. 26D illustrates another embodiment of the selective occlusion device 22v wherein a suitable baffle structure 190 is provided within the selective occlusion device 22v for directing blood flow outwardly as indicated by the arrows toward the connection location between the device 22v and the mitral valve annulus 16 c. This helps to create a fixation force and stability of the device 22v in the implanted state. A single opening 192 is provided to flow during systole and device 22v includes a closed end 194 and a hollow interior 195 such that device 22v fills with blood during systole and collapses during diastole to expel blood as previously shown and described. Generally as previously described, a frame structure 196 is provided to support the flexible membrane 44b, except that the shape and configuration of the frame structure is different to form a single opening 192 defined by a hook or loop frame member 197. It will be appreciated that the shape and configuration of these structures may be modified from those shown in these exemplary embodiments.

Fig. 26E is an embodiment of a device 22w that may be configured as in the previous embodiment with respect to the selective occlusion device 22w, but includes a generally annular or circular frame 200 structure that is a planar element for securing the apparatus 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 substantially adjacent to the mitral valve annulus 16 c. However, it will be appreciated that such structures may be secured in other ways, and additional lower supports may be provided to sandwich cardiac tissue therebetween.

Fig. 27A-27C illustrate another embodiment of a selective occlusion device 22x that may be constructed in accordance with the previously described embodiments, but includes at least one small vent 202 opposite the two openings 140, 142 of the flexible membrane 44 b. The size of the vent 202 is not large enough to cause any significant back flow or leakage of blood in the systole. To some extent, the vent 202 does not allow any significant back flow of blood, the one 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 flexible membrane 44b functions and acts in the manner shown and described previously for purposes and purposes. The one or more vents 202 may, for example, provide pressure relief to reduce the force on the device 22x during the high pressure systolic portion of the cardiac cycle.

Fig. 28A-28C illustrate another embodiment of an apparatus that includes a central clip structure 50 and the selective occlusion device 22p previously described. In this embodiment, the clip structure 50 includes a central gripping structure 210, which central gripping structure 210 may have tines or other embossed, roughened, or rubbed surfaces. This will assist in clamping and retaining the 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 further illustrate that the selective occlusion device 22p operates in the same manner, e.g., as described above, in fluid communication between two generally adjacent openings 140, 142 for enhanced washing and rinsing.

Fig. 29A, 29B and 30 illustrate the device of fig. 28A to 28C in operation after implantation 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 expands or swells into contact with the native mitral valve leaflets 16a, 16B to form a fluid seal that prevents backflow of blood during contraction (fig. 29A and 29B). This is shown in fig. 29B, where the anatomy of the mitral valve 16 is further illustrated, and the native leaflet tissue contacts the outer surface of the flexible membrane 44B during systole.

Fig. 31 illustrates another embodiment showing a deployable prosthetic heart valve 220 that may include a generally cylindrical outer or peripheral frame structure 222 and coupled with an inner prosthetic leaflet 224, the inner prosthetic leaflet 224 opening and closing to control blood flow therethrough. This differs from other forms of selective occlusion devices having at least one movable valve element (e.g., a flexible membrane that operates in conjunction with the native mitral valve leaflet) in that the prosthetic heart valve 220 does not operate in conjunction with the native leaflet to control blood flow. Instead, the prosthetic leaflets 224 control blood flow through the prosthetic valve 220. Coupled to the frame structure 222 are the clip structure 50 or elements that directly couple the expandable prosthetic heart valve 220 to the heart valve leaflets (e.g., 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 below the external covering 230, which external covering 230 may be natural, synthetic, biological, bioengineered, or any other suitable medical grade material that may be used with this type of cardiac device.

Fig. 32B-32E illustrate a series of steps for implanting the prosthetic valve 220 of fig. 31 and 32A. In particular, the device may be implanted by transcatheter or more invasive procedures, such as surgical or keyhole or other less invasive procedures. As shown in fig. 32B, a collapsing or folding device 220 is inserted between the mitral valve leaflets 16a, 16B, and a clip structure 50 is used to capture the lower edges (fig. 32C) of the mitral valve leaflets 16a, 16B and clamp them as shown in fig. 32D. As shown in fig. 32E, the expandable prosthetic heart valve 220 is then expanded against the native mitral valve leaflets 16a, 16b to secure the implanted prosthetic heart valve 220 in place within the native mitral valve 16. The prosthetic leaflets 224 then open and close during the diastole and systole phases, respectively, to allow and prevent blood flow through the prosthetic heart valve 220.

Fig. 33 shows another embodiment similar to the previous embodiment shown in fig. 32, but with the addition of an upper flange element 236, the upper flange element 236 helping to secure the prosthetic heart valve 220 by stabilizing the heart valve 220 within the left atrium 12. In this regard, flange 236 is mounted over native mitral valve 16. The flange 236 may abut heart tissue in the lower portion of the left atrium 12. Fig. 34A is a side view of the prosthetic heart valve 220 shown in fig. 33. Fig. 34B is a diagram showing a prosthetic heart valve 220 secured in place within the native mitral valve 16.

Fig. 35A and 35B show in cross-section another embodiment of a selective occlusion device 22y installed in a native mitral valve 16. As in other embodiments, this embodiment includes a flexible membrane 44c, the flexible membrane 44c having an open end facing the left ventricle 14 and receiving blood flow from below when the cardiac cycle is in systole (fig. 35A). During this portion of the cardiac cycle, the flexible membrane 44c expands against the native leaflets 16a, 16b to reduce regurgitation, as previously discussed. During diastole, the flexible membrane collapses and discharges the blood therein (fig. 35B). The blood then travels in the opposite direction through the mitral valve 16, typically by flowing between the native leaflets 16a, 16b and the outer surface of the collapsed membrane 44 c. The difference between this embodiment and the other embodiments is the use of multiple clip structures 50 to secure the selective occlusion device 22y directly to the leaflets 16a, 16b. The leaflets 16a, 16b do not clip onto each other. It will be appreciated that in this and other embodiments, even further clip structures 50 may be used. In this embodiment, the clip structure 50 secures one side of the flexible membrane 44c to the anterior leaflet 16a, while the other clip structure 50 secures the flexible membrane 44c to the posterior leaflet 16b.

As described above with reference to fig. 31-34B, blood flow through the native valve may be controlled by a prosthetic valve that engages with the native valve device by coupling the prosthetic valve to each leaflet of the native valve and between the individual leaflets of the native valve, such as by means of a clip that engages each leaflet and secures it relative to the frame of the prosthetic valve. Prosthetic 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 CoreValve evolout valve provided by Medtronic and Sapien valve provided by Edwards Lifesciences are representative. They have a metallic stent or frame body that may be balloon-expanded (e.g., cobalt chrome) or self-expanding (e.g., nitinol) that can support a tri-leaflet prosthetic valve set (typically formed from animal tissue such as pericardium or natural animal leaflets).

As described in more detail in the embodiments below, the prosthetic valve may also be used to control blood flow through the native heart valve, where edge-to-edge approximation (e.g., using a device such as MitraClip) is performed on the native heart valve ^TM Or pasal clips) that alter native valve pores between native valve leaflets. For ease of illustration and explanation in the following description, the native valve is a mitral valve, i.e., a bileaflet valve having anterior and posterior leaflets, but the devices and procedures described below may also be used or adapted with other native valves having three native leaflets (e.g., tricuspid valve).

For reference, fig. 36A shows a native mitral valve MV having posterior leaflet PL and anterior leaflet AL. The posterior leaflet PL has three segments or petals (scaleps): p1 (anterior or internal lobe); p2 (middle lobe); p3 (posterior or outer lobe). Anterior leaflet AL has three corresponding segments: a1 (front section); a2 (middle section); a3 (posterior segment). The respective segments or petals of the anterior leaflet engage each other to prevent retrograde flow through the valve (from the left ventricle LV into the left atrium LA) during systole—in fig. 36A, the leaflets are shown as coapting, i.e., they are in the position they occupy during systole. The two leaflets AL and PL meet at two commissures (i.e., a posterolateral commissure PMC and a anterolateral commissure ALC). The leaflets extend from the mitral annulus MVA (not shown in fig. 36A).

For further reference, fig. 36B shows a natural tricuspid valve MV having posterior leaflet PL, anterior leaflet AL and septal leaflet SL. In fig. 36B, the leaflets are shown in a closed position, i.e., they are in the position they occupy during contraction. The leaflets meet at three commissures: anterior leaflet AL merges with leaflet SL at the anterior septal commissure; the septal leaflet SL and the posterior leaflet PL meet at a posterior septal commissure PSC, and the posterior leaflet PL meets with the anterior leaflet AL at an anterior-posterior commissure APC.

For further reference, the native mitral valve MV is schematically shown in fig. 37A. In this figure, the edges of the leaflets AL and PL are shown in solid lines, i.e. the leaflet edges are in close proximity to each other (for a qualified native valve), blocking retrograde blood flow, and in dashed lines, i.e. the leaflets are spaced apart, allowing antegrade blood flow from the left atrium LA to the left ventricle LV, when the heart is in diastole.

Fig. 37B to 37D schematically illustrate a native mitral valve MV for which edge-to-edge approximation is performed using one or more clips. As shown in fig. 37B, a single clip CL has been centrally disposed to approximate the edges of the anterior and posterior leaflets AL, PL at their respective A2 and P2 sections. This creates two blood flow control portions through which blood can flow during diastole: FCP1, defined by anterior leaflet AL, posterior leaflet PL, clip CL, and posterior medial commissure PMC; FCP2, which is defined by anterior leaflet AL, posterior leaflet PL, clip CL and anterolateral commissure ALC. Similarly, as shown in fig. 37C, a single clip CL has been placed eccentrically in the native leaflet. Two flow control portions FCP1 and FCP2 are created, but their sizes are substantially different. In the extreme case of eccentric or eccentric clamping, the smaller flow control portion (e.g., FCP1 in fig. 37C) may be of a negligible or negligible size to ensure treatment. Thus, placement of a single clip CL may create a single larger flow control portion. As shown in fig. 37D, the two clips are spaced apart from each other to approach the edges of the anterior and posterior leaflets AL, PL. This creates three flow control sections through which blood can flow during diastole: FCP1, defined by anterior leaflet AL, posterior leaflet PL, clip CL, and posterior medial commissure PMC; FCP2, which is defined by anterior leaflet AL, posterior leaflet PL, clip CL and anterolateral commissure ALC; and FCP3, which is defined by anterior leaflet AL, posterior leaflet PL, and two clips CL.

Fig. 38A to 38F schematically illustrate a natural tricuspid valve TV on which edge-to-edge approximation is performed. Fig. 38A and 38B show a natural tricuspid TV on which two clips CL (e.g., triClip have been used ^TM ) A "three hole" pinch-procedure is performed-fig. 38A shows the tricuspid valve TV in systole, and fig. 38B shows the tricuspid valve TV in diastole). One clip CL connects the anterior leaflet AL and the leaflet SL, while the other clip CL connects the posterior leaflet PL and the leaflet SL. The occlusion createsThree flow control sections through which blood flows during diastole: FCP1, which is defined by anterior leaflet AL, posterior leaflet PL, septal leaflet SL, two clips CL and anterior-posterior commissure APC; FCP2, which is defined by anterior leaflet AL, leaflet SL, one clip CL and anterior septal commissure ASC; and FCP3, which is defined by posterior leaflet PL, leaflet SL, one clip CL and posterior septal commissure PSC.

Fig. 38C and 38D show a natural tricuspid valve TV on which a "mitral" clipping procedure has been performed with two or more clips cl—fig. 38C shows a systolic tricuspid valve TV, and fig. 38D shows a diastolic tricuspid valve TV. All clips CL connect the anterior leaflet AL and the septal leaflet SL. The occlusion creates a large flow control portion through which blood can pass during diastole: FCP1, which is defined in part by one of anterior leaflet AL, posterior leaflet PL, septal leaflet PL and clip CL, anterior-posterior commissure APC and posterior septal commissure PSC.

Fig. 38E and 38F show a natural tricuspid valve TV in which a "three clip variation" clipping procedure is performed using three clips cl—fig. 38E shows the tricuspid valve TV during systole, and fig. 38F shows the tricuspid valve TV during diastole. One clip CL connects the anterior leaflet AL and the leaflet SL, one clip connects the leaflet SL and the posterior leaflet PL, and one clip connects the posterior leaflet PL and the anterior leaflet AL. The clipping procedure also creates a large flow control portion-FCP 1 that can supply blood through during diastole, similar to but smaller than the opening of the natural tricuspid valve prior to the clipping procedure. Thus, the flow control portion FCP1 is defined by the anterior leaflet AL, the posterior leaflet PL, and the leaflet SL, but is not defined by three natural commissures, but by three clips CL.

As described above, using one or more clips (e.g. MitraClip ^TM 、TriClip ^TM Or PASCAL) for edge-to-edge approximation, is to repair a native valve that does not adequately prevent regurgitation (i.e., regurgitation) during contraction. The occlusion technique may reduce or desirably eliminate such regurgitation. Experience has shown, however, that either after surgery or over time (e.g., with the expansion of the heart and corresponding native valve annulus size, or the contraction of the native valve leaflets), at a point resulting from the clamping procedure Backflow may still occur in one or more of the flow control portions FCP. In the above-described embodiments, the selective occlusion device may be provided in one or more of the reflux control portions to reduce or eliminate reflux. The selective occlusion device can be engaged with the clip to hold or assist in holding the device in a desired position relative to the native valve and the flow control portion. The selective occlusion device may also be supported relative to the native valve by means 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, the prosthetic valve may be disposed in one or more regurgitation controlling portions. Devices and systems incorporating such prosthetic valves may employ similar structures and techniques for engaging clips and/or native valve devices to hold the prosthetic valve in place.

One embodiment of the prosthetic valve 100 is schematically illustrated in side and top views in fig. 39A and 39B, respectively. In the following description, some reference numerals are used that are identical to those in the previous description. The reference numerals used below are intended to keep the interior consistent, and thus correspondence of structures or functions of elements having the same reference numerals in the foregoing and following descriptions should not be inferred. As shown in fig. 39A and 39B, the prosthetic valve 100 includes a body 110 having an inlet portion 112, a transition portion 113, and an outlet portion 114. The outlet portion 114 includes a first lobe (limb) 116 and a second lobe 117, and may optionally include a third lobe 118. The body 110 defines a flow passage 130 therethrough, the flow passage 130 including a flow control passage 132 in the inlet portion 112, a branch or transition passage 133 in the transition portion 113, a first lobe passage 134 in the first lobe 116, and a second lobe passage 136 in the second lobe 117, and may optionally include a third lobe passage 138 in the optional third lobe 118.

All portions of the flow channel 130 are in fluid communication with each other and fluid (e.g., blood) may be passed from an inlet 131 at the inlet of the flow channel 130 through the flow control channel 132, through the transition channel 133; and out through the first flap channel 134 from a first outlet 135 at the outlet of the first flap channel 134 or out through the second flap channel 136 from a second outlet 137 at the outlet of the second flap channel 136 and optionally out through an optional third flap channel 138 from a third outlet 139 at the outlet of the optional third flap channel 138.

Flow through flow channel 130, and in particular through flow control channel 132, is controlled by flow control device 160. Flow control device 160 may be constructed and function similarly to the known prosthetic valves described above, and may be implemented as a tri-leaflet valve having three leaflets. Other valve structures may be suitable, including valves having fewer than three leaflets, which may be coaptated with fixed structures in the valve in addition to, or instead of, other leaflets, as described in more detail below in particular embodiments. 39A-40B, the flow control device 160 may be cylindrical with a circular cross-section. The flow control device 160 may be mounted to the inlet portion 112 of the body 110 and arranged such that all flow through the flow control channel 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.

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

The prosthetic valve 100 also includes a clip connector 170 that is part of the body 110 or coupled to the body 110 and is configured to engage a clip, such as the clip described above, to 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 fluid dynamic loads applied to the prosthetic valve 100 during a 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 sustained is often during systole, while the displacement to be resisted is toward the atrium.

The clip connector can be implemented in a variety of configurations, including those described above in connection with 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 the clip structure, such as 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 connector 54), fig. 15A-15E, and fig. 27A-27C (with the clip directly engaging the reinforced central fabric region 130 of the flexible membrane 44A or 44 b).

Fig. 40A and 40B show the prosthetic valve 100 disposed in a native heart valve in side and top views, respectively. Note that for ease of illustration, the prosthetic valve 100 shown in fig. 40A and 40B does not have the optional third flap 118 and associated third flap channel 138 and third outlet 139, and the native heart valve is shown as mitral valve MV. Similar to the mitral valve MV shown in fig. 37B, the mitral valve MV is shown with anterior and posterior leaflets AL, PL connected by a clip CL in an edge-to-edge approximation. Thus, the mitral valve MV is provided with two flow control portions defined between the clips, leaflets and commissures of the mitral valve MV: FCP1 and FCP2.

As shown in fig. 40A and 40B, the prosthetic valve 100 may be disposed in the mitral valve MV with the inlet 131 disposed in the left atrium LA and the first and second outlets 135, 137 disposed in the left ventricle LV. The first flap 116 is shown disposed in the flow control portion FCP1 and the second flap 117 is shown disposed in the flow control portion FCP2. The clip connector 170 engages the clip CL. An optional annulus connector 180 may 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., prevent backflow of blood from the left ventricle to the left atrium during systole, but allow blood to flow from the left atrium LA to the left ventricle LV via the prosthetic valve 100 during diastole.

As described above, the prosthetic valve 100 can be used with other native heart valves, including other atrioventricular valves, tricuspid valves. For example, a prosthetic valve with an optional third flap may be used in a tricuspid valve that uses a three hole clamping procedure in which each of the three flaps may be treated in each of the three resulting flow control portions, respectively. However, in some cases, it may be preferable to use a prosthetic valve in such tricuspid valve that does not include a third flap, to place each of the two flaps in two of the three flow control portions, and to allow the third flow control portion to function only with the native leaflet.

The height of the inlet portion 112 of the body 100, or the total height of the inlet portion 112 and the transition portion 113, may be any suitable distance, although it is desirable that this distance is not too great to prevent blood from flowing into the inlet 131, i.e. that there is sufficient space above and around the inlet 131 in the atrium for free blood ingress.

The absolute and relative dimensions (cross-sectional area) of the flow control channel 132 (and flow control device 160) and the first and second flap channels 134, 136 (and optionally the third flap channel 138) may be varied to optimize the function, to match the anatomy of the heart, heart volume, etc., or to take into account other relevant factors.

Each of the first and second petals 116, 117 can be configured such that its outer surface engages with the anterior and posterior leaflets in a substantially sealing relationship to reduce or prevent blood flow therebetween during at least a portion of the cardiac pumping cycle. In some embodiments, each of the first and second petals can be sized (e.g., perimeter) and configured (e.g., circular, elliptical, oval, etc. in cross-sectional shape) to substantially fill or overfill (stretch) the respective flow control channel to maintain the edges of the petals sealed with the outer surfaces of the first and second petals throughout the cardiac cycle, thereby preventing flow from the atrium to the ventricle between the petals and the petals during diastole and from the ventricle to the atrium during systole. In this configuration, substantially all blood flow from atrium to ventricle is thus delivered through the prosthetic valve (and thus through the flow control device) during diastole, and blood flow from ventricle to atrium is substantially prevented (by the flow control device 160) during systole (regurgitation). This configuration provides several benefits: first, the natural leaflet will move little or no during the cardiac cycle, which will reduce wear caused by repeated contact between the leaflet and the outer surface of the prosthetic valve flap (little momentum on the natural leaflet upon impact with the flap). Natural leaflets are flexible, which tend to fill any irregular shape or closure defects. Second, the valve should be ensured to be completely sealed, i.e. to prevent regurgitation. Finally, in patients requiring repair or replacement of valves, the heart tends to deteriorate over time. For such patients, regurgitation should not occur again, as the prosthetic valve is virtually fully responsible for the function of the native valve, and the residual valve tissue will be able to fill any gaps that may occur when the heart expands (or any gaps that may occur when the valve leaflets contract as the disease progresses). These advantages are particularly applicable to native valves where edge-to-edge pinching has been applied. After application of the clip, the overall opening size of the valve is limited by 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 systole.

In another configuration, the petals may be smaller in size than the flow control portion, allowing a gap to form during diastole and allowing a portion of the blood flowing from the atrium to the ventricle to flow through the gap (except for the blood flowing through the flow channel and the flow control device). The petals are preferably sized to provide intimate contact between the petals and the outer surfaces of the petals during contraction to prevent regurgitation between the petals and the petals.

The flaps of prosthetic valve 100 are schematically illustrated in fig. 39B and 40B as elliptical cross-sections. This is because the flow control portion of the native valve resulting from leaflet clamping may be oval or slit-shaped. By forming the petals 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 petals may be more circular (circular or oval) near the clip, with a tear drop shape (more V-shaped) extending toward the commissures. Although the petals are shown schematically in fig. 39B and 40B as being generally linear, or symmetrically disposed about a centerline through the clip, as shown in fig. 36A, there is a natural curve of the commissure lines of the native mitral valve leaflets. An upward curve toward the closed line can be seen when looking down the anterior leaflet of the mitral valve from above. To conform to such anatomy, in some embodiments, the flaps of the prosthetic valve may be arranged to follow the curve of the commissure lines.

The petals 116, 117 (and optionally 118) are shown schematically in fig. 39B and 40B as being straight and parallel to one another. However, in some embodiments, the petals may be straight, but may be non-parallel, and may be angled toward or away from each other. In other embodiments, they may not be straight, but may be arcuate, so the outlet portion 114 of the body 110 may have a horseshoe shape, similar to the shape of the device shown in fig. 26B. Similarly, although in the schematic diagrams of fig. 39A and 40A, the space between the petals 116, 117 (and optionally 118) is shown as rectangular, the space may be arcuate or curved with a large radius of curvature, or may be sharper (more V-shaped).

In fig. 39A to 40B, generally tubular petals 116, 117 (and optionally 118) are schematically shown. However, in some embodiments, it may be useful for the petals to flare outwardly (larger perimeter) toward their respective outlets, as this may cause more blood to enter the flow channel 130 during constriction and cause the leaflets of the flow control device 160 to close. Thus, for example, the outlet end of the flap may have a bell shape.

Although the petals 116, 117 (and optionally 118) are schematically shown in fig. 39B and 40B as having flat ends (i.e., at the outlets 135, 137 (and optionally 139)) that are linear and orthogonal to the central vertical axis of the prosthetic valve 100, in other embodiments the ends of the petals may be of any other configuration, including angled and/or arcuate, so long as they can be reliably positioned in the native valve such that preferably the entire outlet is below the position where the native leaflets sealingly engage the petals 116, 117 (and optionally 188). The outlet may also have a non-planar outflow perimeter, but a scalloped perimeter. For example, the portion of the outflow perimeter that engages the anterior leaflet may extend deeper within the ventricle than the portion corresponding to the posterior leaflet engagement. In this way, the upward surge of blood will first come into contact with this deeper extension of the outlet during contraction and may ensure better contracted filling of the prosthetic valve 100.

The body 110 may be constructed from materials and techniques similar to known prosthetic heart valves, such as those discussed above. For example, the body 110 may 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 metals such as nitinol, etc.), polymer, or other suitable material. The body frame 120 may be formed as a single unitary piece in a Y-shape, or may be composed of separate pieces joined together, such as any of the inlet portion 112, the transition portion 113, the first flap 116, the second flap 117, and (optionally) the third flap 118. Wherein, in embodiments in which the body frame 120 is formed as a separate component, the components may be delivered and implanted separately to facilitate delivery and then coupled together in place in the heart valve. As described in more detail below with reference to particular embodiments, the body frame 120 need not necessarily extend to the outlet portion 114 of the body 110. For example, rigid grafts (such as coated or uncoated polyester, teflon, etc.) can be used without or with minimal frame.

The configuration of the petals 116, 117, and (optionally) 118 can vary. In some embodiments, portions of the body frame 120 within the petals can be configured with a stent frame, a body cover 122 and/or a body liner 123 that can include or add padding (formed of materials such as silicone and pericardium). It may be useful to make the petals more flexible (complatint) so that the petals move with each heartbeat and reduce wear as the leaflet tissue contacts the device. Thus, any or all of the petals may be configured similar to the arrangement described above for a prosthetic valve, such as the embodiments shown in FIGS. 5D, 7A-B, 15A-E, or 18A-B. In such embodiments, the petals can be configured with a frame that allows the overlying biocompatible covering (e.g., pericardium) to move back and forth with each cardiac cycle. In other embodiments, the petals may be configured similar to the occluding device shown in fig. 13A-B and 25A-B, where the occluding device is rigid or static and the natural petals move toward the petals to seal against leakage and prevent wear.

In some embodiments, the flaps of the prosthetic valve may be configured to be adjustable in shape to improve the seal between the flaps and the native leaflets. For example, after the prosthetic valve 100 has been placed in a native valve, an oval balloon or oval stent may be introduced to shape the valve. This approach may also be useful if the body cover 122 and/or body liner 123 on (or within) the flap wears. A new body liner 123 may be applied from inside the petals, delivered to the stent or frame through the flow channels 130. This approach would be particularly useful if the petals were constructed with segments of little or no framing material.

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

The body frame 120 may be covered externally with a body cover 122 and/or internally with a body liner 123, each of which may be formed of any suitable material that is biocompatible, sufficiently impermeable to a fluid such as blood to form the flow channel 130 and retain the fluid within (or external to) the flow channel 130, as well as atraumatically contacting the body 120 with native valve tissue (leaflets, chordae tendineae, heart chamber walls, etc.). Suitable materials may include animal pericardium and synthetic materials such as Dacron (the latter material may be more suitable for covering areas of the body 120 that do not contact heart tissue because it is somewhat frayed).

The body cover 122 and/or body liner 123 may cover or liner the entire body 120, or may be discontinuous and cover only a portion of the body 120. Each may also be attached continuously to each region of the body frame 120 that it covers or lines, but may also be attached around the perimeter or edges of selected regions on the body 120, but not within those regions. Such a configuration may allow blood to pass between struts in, for example, the body frame 120 and expand/dilate the body cover 122 and/or body liner 123 outward, such that it gently contacts the native valve leaflet. The native leaflet will rest against the material of the body cover 122 and/or body liner 123 (e.g., pericardium) that is supported by the blood within the flow channel 130, rather than the solid portion of the body frame 120. The body frame 120 may be formed with struts widely spaced in the contact area to ensure that the body cover 122 and/or body liner 123 will be distended by blood. This can greatly reduce the wear of the native leaflet tissue.

As shown in fig. 39A (but omitted from fig. 40A for ease of illustration), the body 110 may also include an outlet cuff 124 at the outflow ends of the flaps 116 and 117 (and optionally not shown on flap 118) that includes a filler material to reduce the risk of cardiac tissue injury to those portions of the body 120 that may contact during a cardiac cycle. Such filler material may be any useful biocompatible material. Silicone, polyurethane, biopolymer or bioelastomer, dacron, PTFE (teflon) fabrics (suture cuffs commonly used in crimped or folded forms for prosthetic valve suture loops) are a suitable choice for valve structures. Such a filler material or damage-reducing material may be added to any portion of the prosthetic valve 100.

In some embodiments, features may be included in the flow channel 130 to direct fluid (e.g., blood) flow through the prosthetic valve 100. For example, similar to the diversion performed by baffle 190 in fig. 26D above, it may be useful to push fluid toward the side walls of flow channel 130 (e.g., in transition channel 133). As described in connection with fig. 26D, fluid flow forces directed to the sides of the prosthetic valve 100 may reduce the risk of wobble. Alternatively or additionally, fluid (e.g., blood) flowing through the flow channel 130 may be mixed with, for example, a helical member disposed in the transition channel 133, in a manner similar to that described above with reference to fig. 26D. Mixing the fluid around the spiral member may reduce wobble on the prosthetic valve 100 by dissipating energy and directing flow centrally to the flow control member 160. The structure for performing the splitting and/or mixing is schematically shown in fig. 39A as an optional splitter/mixer 150 (the splitter/mixer is omitted from fig. 40A for ease of illustration).

Although the clip CL is described above with reference to fig. 36A-40B as a commercial edge-to-edge flap She Gazi, such as MitraClip or paspal, and the prosthetic valve 100 is configured to engage such a clip after it is used to grip a native leaflet, in some embodiments the clip CL may be configured differently from such a commercial clip and/or may be included as part of a system with the prosthetic valve device 100 and configured to be delivered sequentially or simultaneously with the prosthetic valve 100 as part of an overall valve repair/replacement procedure. As described above, the prosthetic valve 100 is configured to anchor to the clip CL, which in turn is coupled to the tissue of the anterior and posterior leaflets AL, PL, and the prosthetic valve 100 will carry substantial hydrodynamic loads during contraction that must be borne by the clip and the petals She Chengzai. Thus, an enlarged clip anchor may be useful. For example, the clip may consist of two or three paddles (instead of PASCAL and MitraClip ^TM A single paddle of the device) to increase the leaflet area that the clip engages. This allows dynamic loads to be more evenly distributed over a larger leaflet area (and over a greater number of underlying chordae tendineae attached to the joined leaflet sections).

In some embodiments, these loads may be carried in part by other structures without placing the clip or native leaflet in the load path, rather than relying on the clip connector (and thus the clip CL, native leaflet or other native valve tissue) to carry all of the hydrodynamic loads exerted on the prosthetic valve. Thus, in some embodiments, the prosthetic valve may include an optional annulus connector 180 and/or an optional heart tissue tether 190.

As shown in fig. 39A-40B, an optional annulus connector 180 may be part of the body 110 or coupled to the body 110 and configured to engage an annulus (and/or other nearby tissue, including the atrial wall, native leaflets, and/or chordae tendineae) of the native heart valve to enhance stability of the prosthetic valve 100 when placed in the native heart valve, such as to inhibit lateral wobble of the prosthetic valve and/or displacement away from the annulus toward the atrium (during systole) or ventricle (during diastole). The annulus connector 180 may be implemented similarly to the annulus connectors described above with reference to the various embodiments of the selective occlusion device, including: fig. 22E (where the annulus connectors 154 and 152 are configured as elongate frame members extending longitudinally from the frame of the selective occlusion device and may engage a peripheral portion of the mitral valve annulus, the connectors 154 may engage tissue on the atrial side of the annulus and the connectors 158 may engage tissue on the ventricular side of the annulus); fig. 22F (with a single annular ring connector 164 coupled to the frame of the selective occlusion device and engageable with substantially the entire periphery of the atrial surface of the annulus, thereby preventing wobble 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 with the annular ring connector configured as a frame structure 200, the frame structure 200 being a planar element that can be secured to the atrial side of the annulus, and may alternatively or additionally have a similar structure that can be secured to the ventricular side of the annulus). The annulus connector 180 may be configured with a non-tissue penetrating member or a tissue penetrating member.

As shown in fig. 39A-40B, one or more optional cardiac tissue tethers 190 may be coupled to the body 110, clip connector 170, clip CL, and/or annulus connector 180. For ease of illustration, not all of the options are shown in all of the figures. The cardiac tissue tether 190 may be an elongate tension member implemented as a wire, a polymer suture (monofilament or braided structure), or other suitable biocompatible material having sufficient tensile strength to carry the desired portion of the hydrodynamic load exerted on the prosthetic valve 100. Each such tether may include a suitable anchoring mechanism by which the free end of the tether (opposite the end connected to the prosthetic valve 100) may be secured to the heart tissue. Such tether anchors 192 may include any known mechanism for securing a tether or suture to tissue (including heart tissue), such as pins, screws, clips, suture loops, or enlarged structures (swabs, discs) that may be disposed on the opposite side of the tissue wall from the tether body. The one or more cardiac tissue tethers 190 may be coupled to cardiac tissue including various locations/structures in the heart chamber, such as the apex of the heart chamber, the ventricular septum, any other wall of the heart chamber, one or more papillary muscles, one or more chordae tendineae, and/or the annulus of a native valve.

The prosthetic valve 100 can be delivered to and positioned in the native valve in a variety of methods and sequences, and secured to the clip CL by a clip connector, to the annulus (and/or nearby tissue) by an annulus connector, and/or to other cardiac tissue by a cardiac tissue tether. Delivery, positioning and/or fixation may also be performed as part of an integrated procedure with edge-to-edge approximation of the clip CL, sequentially after edge-to-edge approximation in the same interventional procedure, or as a separate procedure for a patient who has previously undergone edge-to-edge approximation. Some options are described with reference to method 200 shown in the flow chart in fig. 41. At step 201, one or more clips CL can optionally be delivered to the native valve and used to grip the native valve for edge-to-edge approximation. As described above, the procedure may create two flow control portions, each defined by the commissures of the native valve and the native valve (or) clip. As described above, step 201 may have been performed in advance in a separate procedure, or may be performed as part of the same procedure as a subsequent part of method 200. At step 202, the clamped native valve may be evaluated for leakage or regurgitation and a determination may be made as to whether any such leakage or regurgitation is sufficiently severe to affect use of the prosthetic valve 100. At step 203, the extent of leakage or regurgitation, the size of the flow control portion, and/or other relevant clinical information may be determined (e.g., by imaging) to enable selection of an appropriate prosthetic valve (e.g., the size of the petals 116, 117 (or alternatively 118). At step 204, the prosthetic valve 100 is delivered to the native valve using a delivery catheter, for example, by known intravascular techniques. At step 205, the prosthetic valve 100 is disposed in the native valve, wherein the inlet 131 of the flow channel 130 is disposed in the atrium of the heart, wherein the first flap 116 of the body 110 of the prosthetic valve 100 is disposed in the first flow control portion FCP1, wherein the first outlet 135 of the flow channel 130 is disposed in the ventricle of the heart, and the second flap 117 of the body 110 of the prosthetic valve 100 is disposed in the second flow control portion FCP2, the second outlet 137 of the flow channel 130 is disposed in the ventricle of the heart. At step 206, the clip connector 170 is coupled to one or more clips CL that are clamped to the native leaflet. In a comprehensive procedure, the clip connector 170 can be coupled to the clip CL before the clip CL is clamped to the native leaflet for edge-to-edge approximation.

Optionally, at step 207, the annulus connector 180 may be engaged with the native annulus (ventricular side and/or atrial side) and/or adjacent tissue. Although 207 is shown after 206 in the flowchart of fig. 41, in some embodiments, the annulus connector 180 may first engage the native annulus, i.e., the prosthetic valve is in place in the native valve, and then the clip connector 170 may be coupled to the clip CL. Also optionally, at step 208, one or more cardiac tissue tethers 190 may engage cardiac tissue at one or more locations in the heart. Further alternatively, at the completion of the method 200, or during a subsequent procedure, if some blood regurgitation is identified and determined to be caused by insufficient sealing between the native leaflets and the leaflets 116, 117 in the flow control portion of the native valve, then in step 210, one or both of the leaflets 116, 117 of the prosthetic valve 100 can be further expanded or re-expanded to remodel or increase the circumference of the leaflets and improve sealing with the native leaflets, as described in more detail below.

42A-42C illustrate a prosthetic valve according to an embodiment. The prosthetic valve 300 includes a body 310, the body 310 having an inlet portion 312, a transition portion 313, and an outlet portion 314, and a first flap 316 and a second flap 317. The body frame 320 includes an elongated longitudinal strut 321a extending from the inlet 360 to the first and second outlets 335, 337 on the outside of the body 320, and a U-shaped elongated strut 321b between the first and second petals 316, 317, which interconnects a series of hoops or rings 321 c. The body 310 also includes an outlet cuff 324 at the outlet end of each flap. The body 310 includes a body cover 322 attached to the entire outer surface of the body 310. The 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 flap passage 334, and a second flap passage 336.

The prosthetic valve 300 further comprises a clip connector 370, which clip connector 370 is realized as a web 371 of material extending between the first flap 316 and the second flap 317, and may be clamped between paddles (pads) of the clip CL and native leaflets of the mitral valve MV in this embodiment. The embodiments and uses of the various clips CL are described below.

Fig. 42D shows a clip CL with a first blade or gripping member P1, a second blade or gripping member P2 and a spacer SP. The anterior leaflet AL is captured between the first paddle P1 and the first tissue gripper TG1 that is movable relative to the paddle P1 to allow the anterior leaflet AL to be inserted into the free edge between the first paddle P1 and the first tissue gripper TG 1. The posterior leaflet PL is captured between the second paddle P2 and the second tissue gripper TG2 in a similar manner. Independent leaflet capturing, such as current PASCAL and the latest generation MitraClip, is achieved by selectively operating the first paddle P1 and the first tissue gripper TG1 to engage a first (e.g., anterior) leaflet, or the second paddle P1 and the second tissue gripper TG2 to engage a second (e.g., posterior) leaflet ^TM The case of the device. The captured leaflets can be held between the tissue holders TG1, TG2 and the respective cooperating paddles P1, P2, even though the paddles are shown in an open position relative to the opposing paddles, or the paddles are separated by a spacer SP. As shown in fig. 42D, the paddles P1, P2 of the clip are shown in a fully closed position, wherein the captured tissue of the anterior and posterior leaflets AL, PL are in close spatial relationship.

The mesh 371 of the clip connector 370 of the prosthetic valve 300 may be made of multiple layers of fabric material (as shown) or in a laminated structure to enhance its structural strength. The spacer SP is configured with appropriately sized slots to engage the mesh 371 and secure the mesh 371 in a reliable manner and to withstand dynamic loads applied to the prosthetic valve 300 during the cardiac cycle. The clip CL may be designed such that closure of the clip CL may apply an additional web-clamping load across the slot in the spacer SP. Fig. 42E shows a variation in which the mesh 371 of the clip connector 370 is coupled to the clip CL. The clip CL is configured with a pair of barb members BM. The web 371 has sufficient thickness and structural integrity to be penetrable by the 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 web 371 to be inserted in one direction and prevent retraction in the opposite direction. Alternatively, similar to the tissues TG1, TG2, the barb member BM may be moved and operated between an open position receiving the web 371 and a closed position securing the web 371 therein. Such a closed position may coincide with the final closed position of the clip CL.

Fig. 42F shows another variation in coupling the web 371 of the clip connector 370 between the spacer SP and the capture leaflet (e.g., anterior leaflet AL). The tissue gripper TG1 is provided with a second series of barbs BR 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 371 between the spacer SP barb BR and the tissue gripper TG1 and closing the clip CL will securely couple the prosthetic valve 300 to the clip CL. Insertion of the mesh 371 is facilitated by: the paddle PA and tissue holder TG1 are engaged with the anterior leaflet AL, but the anterior leaflet AL is selectively positioned in the paddle P1 in its open position spaced from the spacer SP.

The prosthetic valve 300 also includes an annulus connector 380 (not shown in fig. 42A for ease of illustration). In this embodiment, the annulus connector includes a first arm 381 and a second arm 383. The first arm 381 is an arcuate elongated rod or post coupled to the inlet portion 312 of the body 310 and extending laterally downward and terminating at its distal end in a first annulus anchor 382 which is a transverse arcuate elongated rod or post sized and oriented to engage the annulus of a native valve, such as the mitral valve annulus MVA of the mitral valve MV, as shown in fig. 42C. (note that fig. 42B and 42C illustrate a slightly different embodiment of the valve ring connector 380—in fig. 42B, first arm 381 and second arm 383 are coupled to the inlet portion 312, while in fig. 42C, first arm 381 and second arm 383 are coupled to first flap 316 and second flap 317.) second arm 383 is a mirror image of first arm 381 and terminates in a second valve ring anchor 384, which is a mirror image of first valve ring anchor 382. In the embodiment of fig. 42B, the annulus connector 380 is configured to engage the upper atrial side of the mitral valve annulus MVA, but in the embodiment of fig. 42C it is configured to alternatively engage the lower ventricular side of the mitral valve annulus MVA, or the prosthetic valve 300 may comprise two annulus connectors, one on each side of the annulus.

The prosthetic valve further includes a flow control device 360, which in this embodiment is a tri-leaflet, disposed in the flow control channel 322 and coupled to the body frame 320 in the inlet portion 312 of the body 110. Blood flow through the prosthetic valve is shown with arrows, i.e., blood may flow from the left atrium LA into the inlet 331, into the flow control channel 332, through the flow control device 360, into the transition channel 333, into both the first flap channel 334 and the second flap channel 336, and out 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.

A prosthetic valve according to another embodiment is shown in fig. 43. The prosthetic valve 400 in fig. 43 is similar to the prosthetic valve 300 in fig. 42A-42 c—the following description focuses on differences of interest and common details are omitted. The clip and the annulus connector are shown in phantom for reference. This embodiment has structural variations that can reduce natural leaflet wear.

The prosthetic valve 400 includes a body frame 420, the body frame 420 being formed with different structures in different portions. In the inlet portion 412, the transition portion 413, and portions of the first and second flaps 416, 417, the body frame 420 has a diamond honeycomb-shaped metal mesh configuration, for example, by using a laser cut tube (typically for a stent or body of a prosthetic valve). However, in the portions of the first and second flaps 416, 417 that are to be disposed in the flow control portion of the clamped 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 petals has a gap in the leaflet contact region 416a of the first petal 416 and the leaflet contact region 417a of the second petal 417, and the gap is spanned by a small amount of wire (or elongated rod) 421d that connects the stent-like portions. The wires may preferably be disposed adjacent the lateral medial and lateral edges of the valve leaflet so that when the prosthetic valve 400 is disposed in the mitral valve, the wires are adjacent the clip and valve commissures, i.e., away from the native valve leaflet, to minimize direct contact with the native valve leaflet. Additional wires or other support structures can be added as needed to maintain the shape of the petals in the leaflet contact area. The outlet end of each flap may be formed with a different structure than the stent frame, such as a simple round or oval wire.

The entire body frame 420 is covered with a body cover 422, which in this embodiment is made of pericardial tissue. The body cover 422 is secured to the stent-like portion of the body frame, i.e., above and below the leaflet contacting region of the leaflet, but may not be attached to the underlying wire in the leaflet contacting region. Thus, the engagement of the native leaflet with the body cover 422 in the leaflet contact region places less stress and wear on the tissue of the native leaflet because the body cover is supported only by the blood in the first and second leaflet passages 434 and 436.

A prosthetic valve according to another embodiment is shown in fig. 44. The prosthetic valve 500 in fig. 44 is similar to the prosthetic valve 300 in fig. 42A-42 c—the following description focuses on differences of interest and common details are omitted. The clip and the annulus connector are shown in phantom for reference. Fig. 44 shows an alternative way of maintaining the prosthetic valve 500 in the correct spatial relationship with the flow control portion FCP, i.e. by maintaining the spatial relationship with the annulus connector, without the use of a clip connector. This embodiment has another variation in structure that reduces the wear of the natural leaflet. Although a typical stent-mounted prosthetic valve is covered, in whole or in part, by a fabric, such as dacron, the prosthetic valve 500 includes a body cover 522 having two portions (i.e., a body cover inlet portion 522a and a body cover flap portion 522 b), each formed of a different material. The body cover flap portion 522b, which is the portion of the body cover 522 that contacts the native leaflet during use, is formed from pericardium or similar biological material. Such biological material is less prone to fraying the native valve leaflets than the fabric material covering the remainder of the prosthetic valve 500.

45A-45C illustrate a prosthetic valve according to another embodiment. The prosthetic valve 600 in fig. 45A-45C is similar to the prosthetic valve 300 in fig. 42A-42 c—the following description focuses on differences of interest and common details are omitted. The clip and the annulus connector are shown in phantom for reference. This example is intended to illustrate a process that may be used to address leakage between the petals and the native leaflets of a prosthetic valve.

To effectively prevent mitral regurgitation, the native leaflets should sealingly engage with the flaps of the prosthetic valve. It is well known that as heart failure causes heart deterioration, the native leaflets become more dispersed and regurgitation increases. It is contemplated that the native valve leaflets may be spread apart sufficiently so that the native valve leaflets no longer sealingly engage the valve flaps of the prosthetic valve. This potential problem may be addressed by a procedure in which one or more of the first and second petals 616, 617 may be expanded to a larger circumference after the prosthetic valve 600 has been delivered. Such a procedure may be performed in conjunction with a procedure in which the prosthetic valve 600 is delivered and deployed, such as by evaluating the seal of the native valve against the first and second petals 616, 617, such as by measuring the presence and severity of regurgitation, and using the procedure to address any such regurgitation. Alternatively, the procedure may be performed separately, such as after an initial procedure to deliver and deploy the prosthetic valve 600 has been performed and deterioration of the heart results in the onset or increase of regurgitation.

The procedure of reshaping or augmenting the perimeter of the first flap 616 and/or the second flap 617 can be accomplished in a variety of ways. First, as shown in fig. 45B, a catheter C with an inflatable balloon B with a balloon-inflatable stent ST disposed thereon (e.g., made of stainless steel or cobalt chrome) may be delivered to the native valve and into a second flap channel 636 of the second flap 617 (via flow control channel 632, flow control device 660, and transition channel 633). Balloon B may then be inflated, stent ST inflated, engaged with the second flap portion of body frame 620, and then inflated. The final state of the prosthetic valve 600 is shown in fig. 45C, with the stent ST in place in the second flap 617. If the dashed line in fig. 45C shows the original size of the second flap 617, the arrows indicate expansion of the stent ST, while the solid line shows the expanded size of the new second flap 617.

Another method of expanding the periphery of, for example, the second flap 617 is to use a self-expanding stent ST (e.g., a stent formed of a shape memory material such as nitinol) and deliver it to the second flap 617 with a catheter (not shown) having a delivery lumen from which the stent ST can be delivered into place. It is well known that one benefit of using a self-expanding stent is: such stents may be retrieved (e.g., through a delivery catheter before deployment is complete, or through a retrieval catheter if already deployed) if delivery is unsatisfactory or the stent fails.

A third method of expanding the periphery of, for example, the second petals 617 (which can result in the state shown in fig. 45C) 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 body frame 620 in the second petals 618 from the initially delivered and deployed periphery, for example, if the portion of the body frame 120 is constructed of an expandable material such as stainless steel or cobalt chrome (rather than a shape memory material).

A prosthetic valve according to another embodiment is shown in fig. 46A-46C. The prosthetic valve 700 in fig. 46A-46C is similar to the prosthetic valve 300 in fig. 42A-42 c—the following description focuses on differences of interest and common details are omitted. This embodiment is intended to illustrate that the prosthetic valve 700 can have a relatively short axial height (particularly in the left atrium) and a relatively larger inlet diameter flow control channel.

The prosthetic valve 700 has a body 710, the body 710 having an inlet portion 712, a transition portion 713, and an outlet portion 714 (having a first flap 716 and a second flap 717). The body 710 defines a flow channel that includes 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. Flow control device 760 is disposed in flow control channel 732. As shown in fig. 46B and 46C, 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 and second outlets 735, 735. Thus, when prosthetic valve 700 is disposed in a native valve, such as a mitral valve between left atrium LA and left ventricle LV, as shown in fig. 46B, inlet 731 is disposed in left atrium LA, but with sufficient clearance from the atrial wall to allow good blood flow into flow control device 750. The first outlet 735 and the second outlet 737 are disposed in the left ventricle LV, but do not extend too far into the ventricle, thereby minimizing contact with portions of the native valve apparatus or the ventricle wall. As shown in fig. 46A-46C, the flow control device 760 also has a larger diameter relative to the overall size of the prosthetic valve 700, as do the first and second outlets 735, 737 (and the flow path between the inlet 731 and the outlet), thereby providing a large flow area for blood from the left atrium LA to the left ventricle LV through the prosthetic valve 700 during diastole, as indicated by the arrows in fig. 46B and 46C.

Similar to the prosthetic valve 300, the prosthetic valve 700 includes a clip connector 770, the clip connector 770 being comprised of a structured web 771 extending from and spanning between the first 716 and second 717 flaps of the valve 700. The clip connector 770 may be coupled to the clip CL in various ways as previously described in fig. 42D-42F. Once coupled with the clip CL, the web 771 of the clip connector 770 engages between opposing paddles or clip members of the clip CL and may also engage between the capture portions of opposing and proximate native leaflets (e.g., anterior leaflet AL and posterior leaflet PL in the mitral valve MV).

A prosthetic valve according to another embodiment is shown in fig. 47A-47D. The prosthetic valve 800 in fig. 47A-47D is similar to the prosthetic valve 700 in fig. 46A-46 c—the following description focuses on differences of interest and common details are omitted. This embodiment is used to illustrate the structure used to couple the prosthetic valve 800 to the clip CL.

The prosthetic valve 800 has a clip connector 870, the clip connector 870 transferring fluid dynamic loads applied to the prosthetic valve 800 to the clip CL via the axial clip posts 873. The axial clamp post is in turn connected to the body frame 820 via two paths: i.e., via three radial valve struts 872 that are coupled between the axial clamp posts 873 and an upper edge of the frame of the flow control device 860 (which may be coupled to the body frame 820 or a portion of the body frame 820); and via a U-shaped crotch strut 874, the U-shaped crotch strut 874 being coupled between the axial clamp strut 873 and a portion of the body frame 820 between the first flap 816 and the second flap 817. The body frame 820 includes outlet portions 825 (which may be short sections of a scaffold structure) at the outlet ends of the first and second flaps 816, 817 to hold the first and second outlets 835, 837 open. A downshifting strut 874 may be coupled to the outlet portion 825. The axial clamp posts 873 are coupled to the clamp CL via any suitable mechanical joint (e.g., tongue-and-groove, barb fitting, snap fit, etc.). As such, the prosthetic valve 800 can be coupled to the clip CL as follows: i) After the clip CL is advanced and fully deployed (i.e., both 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 leaflet is captured between the center spacer and the first clip member (e.g., between the spacer SP shown in fig. 42D-42F and the paddle P1 of the clip CL), and before a second native leaflet is captured between the center spacer and the second clip member (e.g., the second paddle P1 shown in fig. 42D-42F); or iii) prior to capturing the leaflets by the clip CL (i.e., prior to delivery to the patient's target heart valve), the prosthetic valve 800 and clip CL form a device assembly. A releasable mechanical connector may also be used to allow the prosthetic valve 800 to be separated from the clip CL and replaced with a different size or configuration prosthetic valve if such replacement is required for surgical intervention.

The radial valve struts 872 are constructed and arranged to be disposed below the commissure lines of the leaflets 862 of the flow control device 860, as best shown in fig. 47A (the leaflets 862 are shown open during diastole) and 47B (the leaflets 862 are shown closed during systole, the radial valve struts 872 are shown in phantom). In an alternative embodiment shown in fig. 48, the prosthetic valve 900 includes radial valve struts 972, the radial valve struts 972 being configured and arranged to be disposed above the line of engagement of the leaflets 962 of the flow control device 960. In both embodiments, the radial valve struts 872 and 972 can be securely 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 that have been developed for use in the flow control device without requiring redesign of their design.

In fig. 47C and 47D, a prosthetic valve 800 is shown in an end view and in an exploded view, respectively, placed in a delivery position in a native mitral valve MV. The clip CL is shown in fig. 47D with the paddles P1, P2 open and the natural leaflets AL and PL and the clip connector 870 in relation to the clip CL are clearly seen. The spacer SP is of a suitable size and volume to advantageously allow for the configuration of a mechanical joint or other suitable interface to properly engage the clip connector 870 of the prosthetic valve 800. The latter may be achieved by one or both of the blades P1, P2 being in their open and spaced apart position, or by the blades P1 and P2 being in a closed position and close to the spacer SP.

A prosthetic valve according to another embodiment is shown in fig. 49A-49B. The prosthetic valve 1000 in fig. 49A and 49B is similar to the prosthetic valve 300 in fig. 42A-42 c—the following description focuses on differences of interest and common details are omitted. This embodiment illustrates an alternative design of the valve ring connector.

As shown in fig. 49A and 49B, the prosthetic valve 1000 includes a body frame 1020 integrated with a clip connector 1070 and an annulus connector 1080. Unlike clip connector 870 of prosthetic valve 800 in fig. 47A-47D, clip connector 1070 has a load path through only crotch post 1074. The outlet portions 1025 of the main body frame 1020 are wire hoops or loops, and each outlet portion is coupled at its laterally inner side to the lower end of the crotch post 1074, and at its laterally outer side to a main body frame side post 1026 extending laterally outer side of the main body 1010. Each main body frame side strut 1026 is coupled at its upper end to a frame and/or annulus connector 1080 of the flow control device 1060.

The annulus connector 1080 includes first and second arms 1081, 1083, each extending from an upper end of the frame and/or corresponding body frame side struts 1026 of the flow control device 1060 and having first and second annulus anchors 1082, 1084, respectively, at distal ends thereof. In this embodiment, the annulus connector 1080 engages the atrial side of the mitral annulus MVA. However, alternatively or additionally, the annulus connector may comprise arms extending through the mitral valve commissures and having an annulus anchor arranged to engage the ventricular side of the mitral valve annulus MVA. The first and/or second loop anchors 1082, 1084 can include tissue-piercing members, such as barbs, for enhancing fixation to heart tissue.

Fig. 50 shows a prosthetic valve according to another embodiment. The prosthetic valve 1100 in fig. 50 is similar to the prosthetic valve 1000 in fig. 49A and 49B, but includes an annulus connector 1180 that engages both the atrial and ventricular sides of the mitral valve annulus MVA.

As shown in fig. 50, the prosthetic valve 1100 comprises a main body frame including outlet portions 1125, each coupled at its laterally inner side to the lower end of the crotch post 1174 and at its laterally outer side to a main body frame side post 1126 extending axially laterally outward of the main body 1110. Each body frame side strut 1126 is coupled at its upper end to a frame of flow control device 1160. The annulus connector 1180 includes two first annulus anchors 1182 and two second annulus anchors 1184 extending from respective body frame side 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 second annulus anchor 1184 engages the atrial side of the mitral valve annulus MVA, while the other second annulus anchor 1184 engages the ventricular side of the mitral valve annulus MVA.

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

51A and 51B show a prosthetic valve according to another embodiment in top view and partial cross-sectional end view, respectively. The prosthetic valve 1200 includes a non-standard flow control device 1260 that may provide better blood flow through the prosthetic valve 1200. Flow control device 1260 may be used with any of the prosthetic valve embodiments described above, such as prosthetic valves 300, 400, 500, 600, 700, 800, 900, 1000, and 1100, rather than the standard tri-leaflet designs.

As shown in fig. 51A and 51B, and in more detail in the perspective views of fig. 51C and 51D, flow control device 1260 includes a stent frame 1261 supporting two conventional leaflets 1262, each facing one third of the perimeter of flow control device 1260. However, the lobes 1262 are not adjacent to each other and connect at a commissure, but are spaced apart from each other, disposed radially opposite each other, and aligned with the first and second petals 1216, 1217, and with the first and second petal channels 1234, 1236, respectively. The leaflets 1262 do not coapt against each other, but rather against static half-cusps 1265, each facing one sixth of the circumference of the flow control device 1260, and are disposed between the leaflets 1262. The flow control device 1265 is shown in fig. 51C in its assumed configuration during contraction, i.e., the tissue leaflet 1262 is in close proximity to the static half-cusps 1265. Flow control device 1260 is shown in FIG. 51D, with tissue leaflets omitted for clarity of illustration of static half-cusps 1265.

As shown in more detail in fig. 51D-51F, each static half-cusp 1265 includes a static cusp frame 1266 and a static cusp 1267 supported on the static cusp frame 1266. Both the leaflet 1262 and the static cusp valve 1267 may be formed from tissue such as the pericardium. The static cusp frame 1266 may be formed of the same material as the main frame of the flow control device 1260, such as stainless steel, cobalt chrome, or nitinol. As shown in fig. 51B and 51D-51F, the static cusp frame 1266 may be coupled to an axial post 1273 of a clip connector 1270. Variations in the structure of the static semi-cusp assembly are possible, including covering or encapsulating frame 1266 with a suitable biopolymer film, such as a silicone poly (polyurethane-urea) formulation. Alternatively, the volume defined by the static cusp frame 1266, static cusp 1267, and stent frame 1261 may comprise collapsible open-cell foam polycarbonate polyurethane covered with a pericardial or biopolymer membrane. Alternatively, the static half-cusps may be constructed of a biopolymer, biocompatible, or bioengineered material that is capable of retaining its shape and geometry in use and is adapted to resist calcification, withstand the stress and strain of the cardiac cycle, and be non-thrombogenic. This material is also suitable for use with the movable cusps in prosthetic valves 300, 400, 500, 600, 700, 800, 900, 1000, and 1100, rather than the more commonly used animal pericardium. An example of a prosthetic Valve using such a biopolymer material is Tria Valve manufactured by Foldax corporation.

In operation of the flow control device 1260, during diastole, the leaflet 1262 opens, collapsing against the periphery of the flow control device, i.e., as shown in fig. 51A. Blood may flow from the left atrium LA into the inlet 1231, through the holes between the leaflets 1262 and the static semi-cusps 1265, and into the first and second leaflet passageways 1234, 1236. As evident in fig. 51A, the alignment of the leaflets 1262 with the leaflet passageways provides a smooth, relatively straight flow path. During contraction, the leaflets 1262 coapt and seal with the static cusp 1267, blocking retrograde blood flow or regurgitation, similar to the coaptation of the leaflets in a three-leaflet valve. In the configuration of the prosthetic valve 1200 with non-diametrically opposed valve passages 1234, 1236 as shown in fig. 51A, the alignment of the leaflets 1262 can be tailored to align with the valve passages by varying the amount of the circumference of each of the static half-cusps 1265 facing the flow control device 1260. For example, in embodiments having first and second petals 1216, 1217 oriented at 160 degrees relative to the clip CL, the first static half-cusps 1265 can be configured to subtend one-ninth of the circumference, and the second half-cusps 1265 configured to subtend two-ninth of the circumference such that the leaflets 1262 are ultimately aligned with the petal channels 1234, 1236.

The above-described prosthetic valve embodiments include a single flow control device to control flow through the (two or more) flow control portions of the clamped native valve by joining together bifurcated flow control channels with two (or more) valve channels extending through the two (or more) valve flaps, each valve channel preferably sealingly engaging a native valve leaflet in a respective flow control portion. In the prosthetic valve embodiments below, separate flow control devices are used to control flow through each flow control portion of the clamped native valve. Thus, for a native valve with two flow control portions, it is desirable to control flow through the two flow control portions with a prosthetic valve (rather than relying solely on the function of the native valve to form the flow control portions to grip the native valve), 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, but where it is necessary or desirable to address regurgitation by only one of the flow control portions, the prosthetic valve includes a single flow control device. Other structures and functions described above with respect to prosthetic valve embodiments are also applicable to and include additional structures or functions in the embodiments described below, as will be apparent from the description below. In general, for ease of reference, the same reference number schemes are used for the preceding and following embodiments, and any structure in the following embodiments corresponding to the structure of the above embodiments may include all the same details of design and implementation, and all the same options and alternatives as described above, unless clearly different from the following detailed description.

An embodiment of a prosthetic valve 2000 is schematically illustrated in side and top views in fig. 52A and 52B, respectively. The prosthetic valve 2000 includes a body 2010 having an inlet 2012 and an outlet 2014. The body 2010 defines a flow passage 2030 therethrough, the flow passage 2030 including a flow control passage 2032 in the inlet portion 2012 and an outlet passage 2034 in the outlet portion 2014.

Portions of the flow channel 2030 are in fluid communication with each other and can direct fluid (e.g., blood) from an inlet 2031 at the inlet to the flow control channel, through the flow control channel 2032 and out an outlet 2035 at the lower end of the body 2010 through an outlet channel 2034.

Flow through flow channel 2030, and in particular through flow control channel 2032, is controlled by flow control device 2060. The flow control device 2060 may be similar in structure and function to any of the flow control devices described above for other embodiments. As schematically illustrated in fig. 52A-53B, the flow control device 2060 may be cylindrical with a circular cross-section. The flow control device 2060 may be mounted to the inlet portion 2012 of the body 2010 and positioned such that all flow through the flow control channel 2032 must pass through the flow control device 206. The flow control device 2060 is configured to allow fluid flow in a direction from the inlet 2031 to the outlet 2035 and to prevent fluid flow in the opposite direction.

It is well known that tissue valves may fail, and it is also known that this problem can be solved by delivering another tissue-based stent valve within the failed valve. Thus, it is contemplated that a new tri-leaflet may be placed within flow control device 2060 if flow control device 2060 fails.

The prosthetic valve 2000 also includes a clip connector 2070 that is part of the body 2010 or is coupled to the body 2010 and is configured to engage the clip described above to thereby maintain 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 hydrodynamic loads applied to the prosthetic valve 2000 during a cardiac cycle to the clip CL and thereby to the native valve leaflets, annulus and surrounding heart tissue to resist displacement of the prosthetic valve. The maximum load to be carried is often during systole, while the displacement to be resisted is towards the atrium of the heart.

The clip connector may be implemented in a variety of configurations, including the configurations described above, as well as other variations described in more detail below. As described above, the clip CL may be of any commercially available design, or may be customized or modified to be specific to the prosthetic valve 2000. For example, as described in more detail below for particular embodiments, the clip CL can have a spacer disposed between the paddles of the clip (similar to the spacer of a pasal 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 clamping, thereby reducing the size of or filling a portion of the native valve orifice area. The spacer may be configured and dimensioned to increase the resulting flow control (e.g., adjacent the commissures between the native leaflets) relative to clamping the same native valve with a clip without the spacer, and thereby the paddles are disposed proximate to each other.

As schematically shown in fig. 52A-53B, the prosthetic valve 2000 may include a second body 2010' and an associated flow control device 2060' that may also be connected to the clip connector 2070 and may also have an optional annulus connector 2080' (or to the same annulus connector 2060). Body 2010 'may be identical in structure and function to body 2010, including a flow channel 2030' having an inlet 2031', a flow control channel 2032', an outlet channel 2034', and an outlet 2035'. The body 2010 'may have a body frame 2020', or the like. The prosthetic valve 2000 with bodies 2010 and 2010 'may be used to control blood flow in a clamped native valve having two flow control portions that require reduced regurgitation-the body 2010 may be disposed in the first flow control portion FCP1 and the body 2010' may be disposed in the second flow control portion FCP2, as shown in fig. 53A and 53B.

In fig. 53A and 53B, the prosthetic valve 2000 is shown disposed in a native heart valve in side and top views, respectively. Note that for ease of illustration, the native heart valve is shown as mitral valve MV. Note also that the prosthetic valve 2000 is shown with an optional second body 2010' disposed in one of the two flow control portions of the sandwiched mitral valve MV. Mitral valve MV is shown as connecting anterior leaflet AL and posterior leaflet PL by clip CL in an edge-to-edge approximation, similar to mitral valve MV shown in fig. 37B. Thus, the mitral valve MV has two flow control portions FCP1 and FCP2 defined between the commissures of the clip, leaflet, and mitral valve MV. As discussed above with reference to fig. 37A-38F, there are many possible clip arrangements on the mitral or tricuspid valve: one, two, or three flow control portions are created—prosthetic valve 2000 may be used with any of these clamped valve configurations to account for regurgitation of one or both of the flow control portions.

As shown in fig. 53A and 53B, prosthetic valve 2000 may be disposed in mitral valve MV, inlets 2031 and 2031 'disposed in left atrium LA, and outlets 2035 and 2035' disposed in left ventricle LV. The body 2010 is shown disposed in the flow control portion FCP1, and the body 2010' is shown disposed in the flow control portion FCP 2. The clip connector 2070 engages with the clip CL. Optional annulus connectors 2080 and 2080' may be engaged with the mitral valve annulus MVA. Similarly, an optional cardiac tissue tether 2090 may be engaged with cardiac tissue, such as in the left ventricle LV. When the prosthetic valve 2000 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., prevent backflow of blood from the left ventricle to the left atrium during systole, but allow blood to freely flow from the left atrium LA to the left ventricle LV through the prosthetic valve 2000 during diastole.

The height of the inlet 2012 of the body 2000 may be any suitable distance, but is preferably not so great that blood flow into the inlet 2031 is impeded, i.e., there is sufficient space above and around the inlet 2031 in the atrium for free blood ingress.

Each of the bodies 2010 and 2010' may be configured such that an outer surface thereof engages the anterior and posterior leaflets AL and PL in a substantially sealing relationship to reduce or prevent blood flow therebetween during at least a portion of the cardiac pumping cycle. In some embodiments, each of the first body 2010 and the second body 2010 'is sized (e.g., perimeter) and configured (e.g., circular, elliptical, oval, etc. in cross-sectional shape) to substantially fill or overfill (stretch) the respective flow control portion, maintaining the edges of the leaflets in sealing relationship with the outer surfaces of the first body 2010 and the second body 2010' throughout the cardiac cycle, thereby preventing flow between the outlet portion and the leaflets from flowing 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 atrium to ventricle passes through the prosthetic valve (and thus through the flow control devices 2060, 2060 ') during diastole, and blood flow from ventricle to atrium is substantially prevented (by the flow control devices 2060 and 2060') during systole (regurgitation). This configuration provides several benefits. First, the natural leaflet does little or no movement during the cardiac cycle, which reduces wear caused by repeated contact between the leaflet and the outer surface of the prosthetic valve body (little momentum on the natural leaflet during collision with the outlet portion). Natural leaflets are flexible and tend to fill any irregular shape or closure defects. Second, the valve should be ensured to be completely sealed, i.e. to prevent regurgitation. Finally, in patients requiring valve repair or replacement, the heart tends to deteriorate over time. For such patients, regurgitation should not occur again, as the prosthetic valve is actually fully responsible for the function of the native valve, and the residual valve tissue will be able to fill any gaps that may occur when the heart expands (or alternatively, any gaps may occur when the valve leaflets contract as the disease progresses). These advantages are particularly applicable to native valves where edge-to-edge clips have been 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, it is necessary to reduce the surface or orifice area occluded by the valve, as well as reduce the load on the prosthetic valve. In many cases, the clip can hold the load created by the systole securely, highest during systole.

In another configuration, the body 2010, 2010' may be smaller in size than the flow control portion, allowing a gap to form during diastole and allowing some blood flowing from the atrium to the ventricle to flow through the gap (in addition to the blood flowing through the flow passage and the flow control device). The dimensions of the body 2010, 2010' are preferably such that the leaflets can sealingly engage the outer surface of the body during contraction and prevent backflow between the leaflets.

The body 2010, 2010' of the prosthetic valve 2000 is schematically shown in fig. 52B and 53B as a circular cross-section, while the flow control portion of the native valve resulting from leaflet clamping may be oval or slit-shaped, as shown in fig. 53B for ease of illustration. Shaping the body with a corresponding cross-section, however, may better follow the shape of the flow control portion and fill the leakage space. In some embodiments, the cross-sectional shape of the body may be more oval, or have a tear drop (more V-shape) shape, with the narrower portions oriented toward the commissures, at least in the leaflet contact region. Although the body is shown schematically in fig. 52B and 53B as being nearly linear in shape, or symmetrically arranged about a centerline through the clip, as shown in fig. 36A, there is a natural curve of the commissure of the native mitral valve leaflet. There is an upward curve to the closed line when looking down the mitral valve over the anterior leaflet. To conform to such anatomy, in some embodiments, the body of the prosthetic valve may be arranged to follow the curve of the commissure lines (i.e., the curve formed by the leaflet free edges of the opposing mitral or tricuspid valves during contraction).

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

The body 2010, 2010' is schematically illustrated in fig. 52A to 53B, and is generally tubular in shape. However, in some embodiments, it may be useful for the body to flare outwardly (larger perimeter) toward its respective outlet, as this may encourage more blood to enter the flow channel 2030 during contraction and encourage closure of the leaflets of the flow control devices 160, 160'. Thus, for example, the outlet ends of the bodies 2010, 2010' may have a bell shape.

Although the bodies 2010, 2010 'are schematically shown in fig. 52B and 53B as having flat ends (i.e., at the outlets 2035, 2035') that are linear and orthogonal to the central vertical axis of the prosthetic valve 2000, in other embodiments the ends of the bodies 2010, 2010 'may be of any other configuration, including angled and/or arcuate, so long as they can be reliably positioned in the native valve such that preferably the entire outlet is below the location where the native leaflet sealingly engages the bodies 2010, 2010'. The outlet may also have a non-planar outflow perimeter, but a scalloped perimeter. For example, the outflow peripheral section engaging the anterior leaflet AL may extend deeper within the ventricle than the corresponding section engaging the posterior leaflet PL. In this way, the upward surge of blood during the contraction will first come into contact with the deeper extension of the outlet and may ensure better systolic filling of the prosthetic valve 2000.

Each of the bodies 2010, 2010' may be constructed of materials and techniques similar to known prosthetic heart valves, as described above. In the following description, only the body 2010 is described for simplicity, but all discussions are equally applicable to the body 2010'. The body 2010 may have a body frame 2020 formed of wire, 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 2020 may be formed as a single unitary piece or it may be constructed of separate pieces that are connected together, e.g., each inlet portion 2012 is a piece and the outlet portion 2014 is a separate piece. In embodiments where the body frame 2020 is formed as a separate component, the components may be delivered and implanted separately to facilitate delivery and then coupled together in place in the heart valve. As described in more detail below with reference to particular embodiments, the body frame 2020 does not necessarily extend to the outlet portion 2014 of the body 2010. For example, rigid grafts (such as coated or uncoated polyester, teflon, etc.) can be used without or with minimal frame.

The structures of the body 2010 and the body 2010' may be different. In some embodiments, portions of the body frame 2020 within the outlet portion 2014 may be configured with a stent frame, the body cover 2022 and/or the body liner 2023 may include or be padded (formed of materials such as silicone and pericardium). It may be useful to make the outlet 2014 more flexible (complatint) so that the outlet moves with each heartbeat and reduces wear as the leaflet tissue contacts the device. Thus, the outlet portion 2014 may be configured similar to the arrangement described above for a prosthetic valve, such as the embodiments shown in FIGS. 5D, 7A-B, 15A-E, or 18A-B. In such embodiments, the outlet portion may be configured with a frame that allows the overlying biocompatible covering (e.g., pericardium) to move back and forth with each cardiac cycle. In other embodiments, the outlet portion 2014 may be configured similar to the occluding device shown in fig. 13A-B and 25A-B, wherein the occluding device is rigid or static and the native leaflets move toward the petals to seal, thereby preventing leakage and wear.

In some embodiments, the outlet portion 2014 of the prosthetic valve 2000 can be configured to be adjustable in shape to improve the seal between the outlet portion and the native leaflet. For example, after the prosthetic valve 2000 has been placed in the native valve, an oval balloon or oval stent may be introduced to shape the petals of the body portion. This approach may also be useful if the body cover 2022 and/or body liner 2023 on (or in) the outlet 2014 wears. New body liner 2023 may be applied from the interior of body portion 2014, delivered to a scaffold or frame through flow channel 2030. This approach would be particularly useful if the body portion 2014 were configured with segments of little or no framing material.

The flow control device 2060 is coupled to the body frame 2020 in the inlet portion 2012 and supported by the body frame 2020, or may alternatively form part or all of the inlet portion of the body frame 2020.

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

The body cover 2022 and/or body liner 2023 may cover or liner the entire body 2020, or may be discontinuous and cover only a portion of the body 2020. Each may also be attached continuously to each region covered or lined by body frame 2020, but may also be attached around the perimeter or edges of selected regions on body 2020, but not within those regions. Such a configuration may allow blood to pass between struts in, for example, the body frame 2020, and expand/dilate the body cover 2022 and/or body liner 2023 such that it lightly contacts the native valve leaflets. The native leaflet will contact the material of the body cover 2022 and/or body liner 2023 (e.g., pericardium) that is supported by the blood within the flow channel 2030. The body frame 2020 may be formed with struts widely spaced apart in the contact area to ensure that the body cover 2022 and/or body liner 2023 will be distended by blood. This can greatly reduce the wear of the native leaflet tissue.

As shown in fig. 52A and 53A, the body 2010 may also include an outlet cuff 2024 at the outflow end of the outlet portion 2014 that includes a cushioning material to reduce the risk of cardiac tissue injury to those portions that may contact the body 120 during a cardiac cycle. Such a gasket material may be any useful biocompatible material. Silicone, polyurethane, biopolymer or bioelastomer, dacron, PTFE (teflon) fabrics (suture beads typically used in crimped or folded form for prosthetic valve suture loops) are suitable choices for valve structures. Such a cushion or trauma reducing material may be added to any portion of the prosthetic valve 2000.

Although clip CL may be a commercially available edge-to-edge flap She Gazi, e.g., mitraClip ^TM Or PASCAL, and the prosthetic valve 2000 is configured to engage such a clip after it is used to grip the native valve leaflet, in some embodiments, the clip CL may be configured differently than such a commercially available clip (e.g., any of the clips described above with reference to fig. 42D-42F), and/or may be included as part of a system having the prosthetic valve device 2000, and configured as a component of a system having the prosthetic valve device 2000A portion of the entire valve repair/replacement procedure is delivered sequentially or simultaneously with the prosthetic valve 2000. As described above, the prosthetic valve 2000 is configured to anchor to the clip CL, which in turn is coupled to the tissue of the anterior and posterior leaflets AL, PL, and the prosthetic valve 2000 will carry substantial hydrodynamic loads during contraction that must be borne by the clip and the petals She Chengzai. Thus, an enlarged clip anchor may be useful. For example, the clip may consist of two or three paddles (instead of PASCAL and MitraClip ^TM A single paddle of the device) to increase the area of the leaflet that the clip engages. This allows dynamic loads to be more evenly distributed over a larger leaflet area (and over a greater number of underlying chordae tendineae attached to the joined leaflet sections).

In some embodiments, these loads may be partially carried by other structures without placing the clip or native leaflet in the load path, rather than relying on the clip connector (and thus the clip CL, native leaflet or other native valve tissue) to carry all of the hydrodynamic loads exerted on the prosthetic valve. Thus, in some embodiments, the prosthetic valve can include an optional annulus connector 2080 and/or an optional heart tissue tether 2090.

As shown in fig. 52A-53B, an optional annulus connector 2080 may be part of the body 2010 or coupled to the body 2010 and configured to engage with an annulus (and/or other nearby tissue, including the atrial wall, native leaflets, and/or chordae tendineae) of the native heart valve to enhance stability of the prosthetic valve 2000 when placed in the native heart valve, such as to inhibit lateral rocking of the prosthetic valve relative to a plane of the native valve and/or displacement of the prosthetic valve away from the annulus toward the atrium (during systole) or ventricle (during diastole). The annulus connector 2080 may be implemented similar to the annulus connectors described above with reference to the various embodiments of the selective occlusion device and prosthetic valve. The annulus connector 2080 may be configured with a non-tissue penetrating member or a tissue penetrating member. The optional body 2010 'may also have an annulus connector 2080', or may share the same annulus connector 2082 with the body 2010.

As shown in fig. 52A-53B, one or more optional cardiac tissue tethers 2090 may be coupled to the body 2010, 2010', the clip connector 2070, the clip CL and/or the annulus connector 2080, 2080'. For ease of illustration, not all of the options are shown in all of the figures. The heart tissue tether 2090 and its heart tissue anchors 2092 may be implemented in the same manner as the heart tissue tether 190 and heart tissue anchors 192 described above with respect to the prosthetic valve 100 and other embodiments.

The prosthetic valve 2000 can be delivered to and positioned in the native valve by various methods and sequences, and secured to the clip CL by a clip connector, to the annulus (and/or nearby tissue) by an annulus connector, or to other cardiac tissue by a cardiac tissue tether. Delivery, positioning and/or fixation may also be performed as part of an integrated procedure with edge-to-edge approximation of the clip CL, sequentially after edge-to-edge approximation during the same interventional procedure, or as a separate procedure for a patient who has previously undergone edge-to-edge approximation. Some options are described with reference to method 2100 shown in the flow chart in fig. 54. At step 2101, one or more clips CL can optionally be delivered to the native valve and used to grip the native valve leaflet for edge-to-edge approximation. As described above, the procedure may create two flow control portions, each defined by the commissures of the native valve and the native valve (or) clip. As described above, 2101 may be performed in advance in a separate procedure or may be performed as part of the same procedure as a subsequent portion of method 2100. At step 2102, a leak or regurgitation assessment may be performed on the clamped native valve and a determination may be made as to whether any such leak or regurgitation is severe enough to affect use of the prosthetic valve 2000. At step 2103, the extent of leakage or regurgitation, the size of the flow control portion, and/or other relevant clinical information (e.g., by imaging) may be determined so that an appropriate prosthetic valve (e.g., the size of the outlet portion 2014, 2014') can be selected. At step 2104, the prosthetic valve 2000 can be delivered to the native valve using a delivery catheter, for example, by known intravascular techniques. At step 2105, the prosthetic valve 2000 is disposed in the native valve, wherein the inlet 2031 of the flow channel 2030 is disposed in the atrium of the heart, wherein the outlet 2014 of the body 2010 of the prosthetic valve 2000 is disposed in the first flow control portion FCP1, and the outlet 2035 of the outlet channel 2034 is disposed in the ventricle of the heart. Alternatively, for embodiments of the prosthetic valve 2000 comprising the second body 2010', the prosthetic valve 2000' may be configured such that the inlet 2031 'of the flow channel 2030' is disposed in the atrium of the heart, with the outlet 2035 'of the outlet channel 2034' disposed in the ventricle of the heart. At step 2106, clip connector 2170 is coupled to clip CL, which is clamped to the native leaflet. In an integrated procedure, clip connector 2170 can be coupled to the clip CL before it is clamped to the native leaflet for edge-to-edge approximation.

Optionally, at step 2107, the annulus connector 2180 may be engaged with the native annulus (ventricular side and/or atrial side) and/or adjacent tissue. Although in the flowchart of fig. 54, 2107 is shown after 2106, in some embodiments the annulus connectors 2180, 2180' may first engage the native annulus, i.e., the prosthetic valve is in place in the native valve, and then the clip connector 2170 may be coupled to the clip CL. Also optionally, at step 2108, one or more cardiac tissue tethers 2190 may be engaged with cardiac tissue at one or more locations in the heart. Further alternatively, at the completion of method 2100, or during a subsequent procedure, if some blood regurgitation is identified and determined to be caused by insufficient sealing between the native valve leaflets in the flow control portion of the native valve and the outlet portions 2014, 2014' of the bodies 2010, 2010', then at step 2110, one or both of the outlet portions 2014, 2014' may be further expanded or re-expanded to remodel or increase the perimeter of the outlet portions and improve the sealing with the native valve leaflets, as described in more detail above.

A prosthetic valve according to another embodiment is shown in fig. 55A to 55C, which is provided in a centrally clamped mitral valve MV. The prosthetic valve 2200 in fig. 55A-55C includes two bodies 2210 and 2210', which are shown disposed in two flow control portions FCP1 and FCP2 of the mitral valve MV.

The 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 left atrium LA) and an outlet 2235 (shown disposed in 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 left atrium LA) and an outlet 2235' (shown disposed in left ventricle LV) and having a flow control device 2260' disposed therein. As described above, the prosthetic valve 2200 is disposed in a centrally-clamped mitral valve with one body 2210, 2210' disposed in each of the flow control portions FCP1 and FCP 2. The prosthetic valve 2200 is coupled to the clip CL by a clip connector 2270. In this embodiment, the clip connector 2270 includes a transverse strut 2275 coupled between the bodies 2210 and 2210', and a tension member (e.g., suture) 2276 coupled between the transverse strut 2276 and the spacer SP of the clip CL. The prosthetic valve 2200 also includes an annulus connector 2280, the annulus connector 2280 being coupled to the two bodies 2210 and 2210' and configured similarly to the annulus connectors of the several embodiments described above, in this case engaged with the ventricular side of the mitral annulus MVA.

Fig. 55B shows a variation of a portion of a prosthetic valve 2200. The outlet portion of the body 2210, 2210' comprises a leaflet contact region 2216a, 2216a ' which is non-circular in cross-section, extending laterally towards the commissures of the native mitral valve, which helps to close the substantially triangular portions of the flow control passages FCP1, FCP2 which might otherwise not be filled by the body 2210 and 2210 '. These portions of the leaflet contact regions 2216a, 2216a 'may be formed of a "filler material" such as dacron or pericardium to create a desired shape on the outside of the body frame 2220, 2220'.

A prosthetic valve according to another embodiment is shown in fig. 56A-56I, which is disposed in a centrally-clamped mitral valve MV. The prosthetic valve 2300 in fig. 56A, 56B, 56D, and 56E includes a single body 2310, which is shown disposed in one of the two flow control portions FCP1 and FCP2 of the mitral valve MV. Such prosthetic valves and procedures may be useful when only one flow control portion of the centrally-clamped mitral valve (or the clamped tricuspid valve) has an unacceptable level of regurgitation in need of treatment.

The body 2310 of the prosthetic valve may be implemented according to any of the options and features described above. A different aspect of this embodiment is a mechanism for securing the prosthetic valve 2300 into operative relationship with the mitral valve MV using a combination of a suture-based clip connector 2370 and a suture-based cardiac tissue tether 2390.

The clip connector 2370 is implemented as an elongated suture 2377 having two suture folds 2378a, 2378b, the two suture folds 2378a, 2378b slidably disposed on the suture 2377. The free ends of the suture 2377 are adjacent forming a loop (bight) therebetween. Distal (closer to the loop) suture crimp 2378a forms a distal suture loop 2379a with the loop (best seen in fig. 56C-56E). The size (perimeter) of the distal loop 2379a may be adjusted by sliding the distal suture crimp 2378a toward the loop (preferably, the suture crimp is configured to slide in one direction and resist sliding in the other direction so that the suture loop may be tightened around the structure without loosening). Proximal (closer to the free end of suture 2377) suture folds 2378b form proximal suture loops 2379b with distal suture folds 2378a and are operable to form two loops in 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 crimp 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 prosthetic valve 2300 and secured by sliding the proximal suture crimp 2378b distally (thereby securing the body 2310 to the clip CL by the suture 2377).

As shown in fig. 56C, the distal end of delivery catheter C may be inserted into left atrium LA (using any suitable technique, such as transseptal delivery), and suture 2377 may be delivered from the delivery lumen of catheter C. Suture 2377 may be delivered in an annular 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 trans-femoral delivery), and the loop end may be manipulated and maneuvered using conventional techniques. Thus, the distal suture loop 2379a may be inserted through the flow control portion FCP2 into the left ventricle LV, then set attached to the ventricular end of the clip CL, and the free end of the suture 2377 may be pulled proximally to push the distal end of the distal suture loop 2379a up against the superior (atrial) end of the clip CL. Distal suture crimp 2378a may then be slid distally over suture 2377 to secure distal suture loop 379a. Alternatively, the free ends of suture 2377 may be delivered from catheter C and manipulated until it is in the configuration shown in fig. 56C and the free ends give the patient a profile (externalize) so that distal suture crimping can then be applied to both free ends of suture 2377 outside the body and push suture 2377 down through catheter C into the position shown in fig. 56C and then slide suture 2377 further down to tighten distal suture loop 2379a.

As shown in fig. 56C, the same catheter C may then deliver the prosthetic valve 2300 into a proximal suture loop 2379b (not shown in fig. 56C). Then, as shown in fig. 56D and 56E, a body 2310 of the prosthetic valve 2300 may be disposed in the flow control portion FCP2, with a proximal loop 2379b of suture 2377 disposed around the body 2310 of the prosthetic valve 2300. Proximal suture crimp 2378b may be slid distally along suture 2377 to secure the proximal suture loop around body 2310, and the free ends of suture 2377 may be pinched off (clip off) near proximal suture crimp 2378 b-compare fig. 56D and 56E.

In contrast to the technique shown in fig. 56C, two alternative techniques are shown in fig. 56F-56I for disposing the distal suture loop 2379a around the clip CL. In the technique illustrated in fig. 56F and 56G, the distal suture loop 2379a is inserted into the left ventricle LV through the flow control portion FCP2 and then up through the other flow control portion FCP1 into the left atrium LA. The free end of suture 2377 can then be passed through a distal suture loop 2379a (e.g., external to the patient) and pulled proximally, cinching the loop of suture 2377 around the clip CL and the proximal edges of the anterior and posterior leaflets AL, PL. The distal suture crimp 2378a may then be slid distally to secure the distal suture loop 2379a around the clip CL and leaflet tissue. Alternatively, as in the option shown in fig. 56C, instead of delivering a loop of suture 2377 through catheter C, the free end of suture 2377 may be delivered into the atrium, around the clip, and exteriorly visualized, thereby establishing the configuration shown in fig. 56F and 56G.

Another technique is shown in fig. 56H and 56I. In this technique, the free end of suture 2377 is delivered (e.g., through catheter C) into left atrium LA, through flow control portion FCP1 into left ventricle LV, around the posterior leaflet PL side of clip CL, out flow control portion FCP2 into left atrium LA, over clip CL, back into left ventricle LV through flow control portion FCP1, around the anterior leaflet AL side of clip CL, back into left atrium LA from flow control portion FCP2, between suture 2377 and posterior leaflet PL, then back from left atrium LA, and then externalized from the patient. Tension may be applied to the free ends of suture 2377 to tighten the knot around clip CL and the gripping portion of the native leaflet. Distal suture crimp 2378a may then be applied and suture 2377 pushed down into left atrium LA, forming distal suture loop 2379a.

As described above, the prosthetic valve 2300 includes a cardiac tissue tether 2390. Because the prosthetic valve 2300 is laterally offset from the clip CL, the hydrodynamic forces exerted on the prosthetic valve 2300 during the cardiac cycle (pushing it strongly against the left atrium LA during systole and pushing it less strongly against the left ventricle LV during diastole) may exert a shaking force on the prosthetic valve, i.e., rotate about the clip CL. The upward shaking force (generated during contraction) may be counteracted by the cardiac tissue tether 2390. The heart tissue tether 2090 may also be implemented with a suture 2393 and a suture crimp 2394. As best shown in fig. 56C and 56E, a suture loop 2395 of suture 2393 may be disposed about the sub-valve annulus tissue, in which case chordae tendineae of one of the native leaflets extend between papillary muscles PM (the one closest to the flow control portion, or in this case, the posterior medial papillary muscle proximate to the illustrated flow control portion FCP 2) and the native leaflet. The suture 2393 may be passed through the flow control portion FCP2 between the valve body 2310 and the mitral valve annulus MVA, for example near or at the valve commissures. Suture 2393 can be abutted against valve body 2310 by proximal suture loop 2379b, and then suture crimp 2394 can be slid distally along suture 2394 to pull valve body 2310 downward (toward left ventricle LV and papillary muscle PM). Downward tension from the suture 2393 on the valve body 2310 opposes the rocking force generated by blood pressure during contraction, thereby reducing or eliminating rocking of the prosthetic valve 2300 around the clip CL.

Fig. 57A and 57B illustrate a prosthetic valve according to another embodiment. Prosthetic valve 2400 is shown disposed in mitral valve MV with clip CL already applied to anterior leaflet AL and posterior leaflet PL in an off-center position (i.e., not centered). In this case, clip CL has been applied to cusp A1 and cusp P1. Thus, there is a single large flow control portion FCP1 (or there may be a very small flow control portion (not shown in the figures)) between the clip and the closer commissure. A distinguishing aspect of this embodiment is a mechanism that secures prosthetic valve 2400 in operative relationship with mitral valve MV using a cuff coupled to clip CL.

The clip connector 2470 is implemented as a clip connector ring or hoop 2474 that is coupled to the clip CL. The collar 2474 can collapse or compress into a constrained configuration, thereby being suitable for catheter delivery. The clip connector ring 2474 can be formed of a self-expanding material (e.g., nitinol) and can be coupled to and delivered with a clip CL external to the patient, e.g., through a catheter, and disposed on the ventricular side of the anterior and posterior leaflets AL, PL. The clip can be engaged with the leaflet and the clip connector ring 2474 can then be released from the delivery catheter. The clip connector ring 2474 can then self-expand and resiliently return to an unconstrained, expanded configuration (as shown in fig. 57B) such that it is disposed below the native leaflet (on its left ventricular LV side) concentric with the flow control portion FCP 1. The prosthetic valve 2400 can then be delivered (e.g., through the same delivery catheter as used to deliver the clip CL and clip connector ring 2474) into the left atrium LA, with the body 2410 disposed in the flow control portion FCP1 and clip connector ring 2474, and the body 2410 can be expanded (or allowed to self-expand) to securely engage the clip connector ring 2474, as configured in fig. 57A and 57B.

Fig. 58A and 58B illustrate a prosthetic valve according to another embodiment. The prosthetic valve 2500 is also shown disposed in an eccentrically clamped mitral valve MV. The present embodiment differs in that a mechanism is used that secures the prosthetic valve 2500 in operative relationship with the mitral valve MV using struts extending from the clip CL.

Clip connector 2570 is shown with two slight variations in these figures. In fig. 58A, clip connector 2570 includes vertically oriented U-shaped clip posts 2573 extending laterally from the frame of body 2510. The free end of the clip post 2573 can be coupled to the clip CL by any of the mechanical coupling options described above. For example, the terminal ends of the clip posts 2573 can be inserted into appropriately configured openings 2574 in the spacers of the clip CL.

In fig. 58A, clip connector 2570 includes an axial clip post 2573 extending vertically from clip CL and which engages a post 2575 extending laterally from the frame of body 2510.

As shown in fig. 58A and 58B, the prosthetic valve 2500 includes an annulus connector 2580 that is similar to the annulus connector in many of the embodiments described above.

59A and 59B illustrate a prosthetic valve according to another embodiment. The prosthetic valve 2600 is also shown disposed in an eccentrically clamped mitral valve MV. The present embodiment differs in the mechanism for securing the prosthetic valve 2600 in operative relationship with the mitral valve MV, which substantially combines the features of the prosthetic valve 2300 (fig. 56A-56I) and the prosthetic valve 2500 (fig. 58A and 58B).

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

As shown in fig. 59A and 59B, the prosthetic valve 2600 includes an annulus connector 2680, similar to the annulus connector in many of the embodiments described above.

Similar to the prosthetic valve 2300, the prosthetic valve 2600 further includes a cardiac tissue tether 2690 disposed about the chordae CT.

A prosthetic valve according to another embodiment is shown in fig. 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 (fig. 56A-56I), but has a slightly different coupling mechanism for the clip connector 2770.

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

Similar to the prosthetic valve 2300, the prosthetic valve 2700 also includes a cardiac tissue tether 2790 having sutures 2793, a suture loop 2795 that may be placed around the chordae CT, and suture folds 2794. Two variations of the cardiac tissue tether 2790 are shown in fig. 60C and 60D. In the variation of fig. 60C, the cardiac tissue tether 2790 engages the papillary muscle PM instead of the chordae tendineae CT. Suture 2793 passes through papillary muscle PM (e.g., by piercing papillary muscle PM with a needle coupled to suture 2792 and pulling suture 2794 through). Alternatively, an anchor (screw, hook, loop, etc. -not shown) can be coupled to papillary muscle PM, and suture 2793 can be coupled to or passed through the anchor. In the variation shown in fig. 60D, the cardiac tissue tether 2790 includes a tissue anchor 2792, shown schematically as a button or swab, which may be disposed outside of the ventricular wall VW (epicardium), such as at the apex of the ventricle, and a suture 2793 may be secured to the anchor 2793.

Fig. 61A and 61B illustrate a prosthetic valve according to another embodiment. The prosthetic valve 2800 is also shown disposed in an eccentrically clamped mitral valve MV. The difference between this embodiment is that the clip combines clamping, spacing and occlusion functions to achieve a larger flow control portion and thus a larger flow control device, effectively sealing paravalvular leaks.

As shown in fig. 61A, the body 2810 of the prosthetic valve 2800 is disposed in a flow control channel FCP1 formed by eccentrically clamping the posterior leaflet PL and the anterior leaflet AL (i.e., not centered, in this example by clamping the A1 and P1 cusps). The prosthetic valve 2800 is similar to other prosthetic valves disclosed above, such as the prosthetic valve 2500 shown in fig. 58A and 58B, and similarly includes: an axial clip post 2873 (as part of clip connector 2870) similar to post 2573 of prosthetic valve 2500.

The native leaflet is clamped with a clip CL as shown in more detail in fig. 61B. The clip CL includes a spacer SP, a first blade P1, a second blade P2, and a post connector PC to which the axial clip post 2873 may be secured by any suitable mechanism (as described in more detail above). As shown in fig. 61A, the anterior leaflet is secured to the clip CL between the blade P2 and the spacer SP, and the posterior leaflet PL is secured to the clip C1 between the blade P1 and the spacer. As can be seen from fig. 61A, the spacers SP have a significant width between the paddles P1 and P2 such that when the native leaflets are secured to the clip CL, their coaptation edges are separated, rather than resembling a MitraClip ^TM Such clips are so close together. This spaced apart clamping creates a larger (longer perimeter, larger flow area) flow control portion FCP1 than would be the case if the edges of the leaflets AL, PL were clamped directly together. In turn, this enables placement of larger diameter prosthetic valve bodies 2810 having larger flow areas. The edges of the leaflets AL and PL 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, commissures (anterolateral commissure ALC) and the prosthetic valve 2800, and thus also acts as an obturator. The gripping edges of the anterior and posterior leaflets AL, PL remain in a fixed spatial relationship with each other throughout the cardiac cycle. At any stage of the cardiac cycle, no blood flows through the obturator and no blood is in the gripFlow between the leaflet edges. Thus, paravalvular blood leakage or regurgitation between the atria and ventricles is reduced or eliminated.

The prosthetic valve 2800 also includes an annulus connector 2880, which in this embodiment is disposed below the native annulus, resisting upward (toward the atrium) directed hydrodynamic forces, such as during contraction. A distinguishing aspect of this embodiment is to have a clip that has the structure and function of a septum-obturator. The mechanism for securing the prosthetic valve 2600 in operable relationship with the mitral valve MV substantially combines the features of the prosthetic valve 2300 (fig. 56A-56I) and the prosthetic valve 2500 (fig. 58A and 58B).

Fig. 62 shows a prosthetic valve according to another embodiment. The prosthetic valve 2900 is shown disposed in a mitral valve that has been clamped by two spaced apart clamps CL, forming a single large flow control portion FCP1 therebetween. The body 2910 of the prosthetic valve 2900 can be secured to at least one clip CL, and preferably to two clips CL, using any of the structures and techniques described above for other embodiments. For example, as shown in fig. 62, the prosthetic valve 2900 includes a clip connector 2970 that includes a collar 2974, similar to the collar 2474 (fig. 57A and 57B) described above for the prosthetic valve 2400. The collar 2974 is preferably coupled to two clips CL to prevent wobble of the prosthetic valve 2900. Alternatively, clip connector 2970 may be implemented with a suture loop, such as described above with respect to prosthetic valve 2300 (fig. 56A-56I), 2600 (fig. 59A and 59B), or 2700 (fig. 60A and 60B). Securing the body 2910 to the appropriately sized hoops 2974 in this manner prevents overstress or overstretching of the free edge lengths of the anterior and posterior leaflets AL, PL defined between the spaced apart clips CL.

As described above, many embodiments of the above-described prosthetic valves may be used to address regurgitation of the mitral or tricuspid valve. Fig. 63-66 illustrate some exemplary applications of the tricuspid valve.

As shown in fig. 63, tricuspid valve TV has been clamped by two clamps CL using a triple hole technique (as described above with reference to fig. 38E and 38F, which creates three flow control sections, FCP1 (largest) and FCP2 and FCP3 (smaller)). Fig. 63 shows a prosthetic valve 3000 disposed in the flow control portion FCP1. In fig. 63, the heart is in a contracted state such that all of the leaflets (including the leaflets in the prosthetic valve) are in a closed position. The prosthetic valve 3000 is shown with an annulus connector 3080 that engages the atrial side of the tricuspid annulus, and/or the prosthetic valve 3000 may include a heart tissue tether or any other mechanism described above to secure the prosthetic valve in place relative to the native valve. Further, the prosthetic valve 3000 includes a clip connector 3070, which is shown with an axial clip post 3073 connected to two clips CL. However, in other variations, any of the clip connector embodiments described above may be used to secure the prosthetic valve 3000 to the clip CL.

As shown in fig. 64A, tricuspid valve TV has been clamped with three clamps CL in a modified three-hole technique that produces a larger, more central flow control portion FCP1. Fig. 64 shows a prosthetic valve 3100 disposed in the flow control portion FCP1. In fig. 64, the heart is in a contracted state such that all of the leaflets (including the leaflets in the prosthetic valve) are in a closed position. Prosthetic valve 3100 is shown with clip connector 3170 comprising three eyelets 3172 radially protruding from body 3110, which eyelets 3172 are engageable with sutures 3177, each extending from a respective clip CL and having a length from clip CL to respective eyelet 3172 (best seen in fig. 64B) through distal suture crimp 3178 a. Suture 3177 may conveniently be used as a guide wire through which each clip CL is delivered to tricuspid valve TV. The delivery process of the clip CL and prosthetic valve 3100 is shown in fig. 65A-65D.

As shown in fig. 65A, the delivery system for clip CL and prosthetic valve 3100 includes a catheter C that supports prosthetic valve 3100 for delivery through a valve delivery sheath VDS. Valve delivery sheath VDS includes eyelet slots ES through which eyelets 3172 may radially protrude. The valve delivery sheath VDS is disposed in a lumen of the clip delivery cannula CDC through which the clip CL can be delivered. Each clip CL has a delivery guidewire to which it is coupled, which in this embodiment is a suture 3177 of a clip connector 3170. Suture 3177 passes through eyelet 3172, and clip CL is disposed at the distal end of suture 3177, distal from eyelet 3172. Each of the three clips CL can be delivered to the tricuspid valve in sequence as shown in fig. 65B-65D, each clip clamping an adjacent pair of leaflets (as shown in fig. 65B-65D, 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 a clamped tricuspid valve as shown in fig. 64A. The prosthetic valve 3100 can then be sent out of the clip delivery sleeve CDC from the valve delivery sheath VDS and positioned in the flow control portion FCP 1. The proximal end of each of the sutures 3177 may then be tensioned (e.g., from outside the patient's body), and the distal suture folds 3178a pushed over the sutures 3178 and against the eyelets 3172, thereby securing the prosthetic valve 3100 to the clips CL. Suture 3177 may then be clamped or cut to a position proximate to distal suture crimp 3178a and the delivery system removed from the patient.

As shown in fig. 66, tricuspid valve TV has been clamped with three clamps CL in a "double cusp" clamping technique (as described above with reference to fig. 38C and 38D), which creates a single control FCP1. Fig. 66 shows a prosthetic valve 3200 disposed in flow control portion FCP1. In fig. 66, the heart is in a contracted state such that all of the leaflets (including the leaflets in the prosthetic valve) are in a closed position. Prosthetic valve 3000 is shown with an annulus connector 3280 that engages the atrial side of the tricuspid annulus, but in other variations the (or another) annulus connector 3280 may engage the ventricular side of the tricuspid annulus, and/or prosthetic valve 3200 may include a heart tissue tether or any other mechanism described above to secure the prosthetic valve in place relative to the native valve. Further, prosthetic valve 3200 includes clip connector 3270, which is shown with axial clip post 3273 coupled to clip CL nearest valve body 3210. However, in other variations, any of the clip connector embodiments described above may be used to secure prosthetic valve 3200 to one or more of clips CL.

As described above, any of the prosthetic valve embodiments described herein may include a heart tissue tether located between the prosthetic valve and the heart tissue, such as on the ventricular side of the native atrioventricular valve, which may provide tension that resists hydrodynamic forces exerted on the prosthetic valve during contraction, which would tend to displace the prosthetic valve toward the atrium and/or shake the prosthetic valve relative to the plane of the native valve. As noted in the description of prosthetic valves 100 and 2000, such cardiac tissue tethers may be coupled to clip connectors and/or clips (among other options). Fig. 67A-67C illustrate a cardiac tissue tether 3390 that may be coupled between a clip CL and a ventricular apex VA of the heart, and a method for delivering the cardiac tissue tether 3390 and clip CL to the heart. As shown in fig. 67A, a cardiac tissue tether 3390 may be delivered through a catheter C into the left ventricle LV. The cardiac tissue tether 3390 includes a tether anchor 3392 and a suture 3393 that may be used as a guidewire during delivery of the cardiac tissue tether 3390. In fig. 67A, tether anchor 3392 is shown in two positions: i.e., a first location near the middle of the left ventricle LV during delivery, in a delivery (closed or collapsed) configuration, disposed distally of the suture 3393; and a second position disposed on the epicardial surface of the ventricular apex VA in a deployed (expanded) configuration, which is distal to the suture 3393 (shown in phantom for the delivery position) after passing through the puncture through the ventricular apex VA.

In fig. 67B, clip CL is shown after delivery from catheter C, over the left ventricle LV of suture 3393, which passes through the lumen in clip C and serves as a guidewire for delivering clip CL. Suture 3393 is not under tension, thus allowing complete manipulation, positioning and orientation of clip CL through its delivery catheter, including closing paddles P1 and P2 to engage the native valve leaflets.

In fig. 67C, the clip CL is shown fully deployed, i.e., the natural leaflets have been clipped together. The free end of the suture 3393 may be tensioned and the suture crimp 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 provide the desired tension on the clip CL. At this point in the procedure, the suture 3395 may be clamped or cut at the proximal end of the suture crimp 3394 and the remainder of the suture 3393 withdrawn. Any of the prosthetic valves described above may then be delivered to the native valve (e.g., via catheter C) and secured to clip CL with a suitable clip connector. The cardiac tissue tether 3390 is then used to counter the fluid dynamics applied to the prosthetic valve.

While various embodiments have been described herein in terms of text and/or graphics, it should be understood that they have been presented by way of example only, and not limitation. Also, it is to be understood that the specific terminology used herein is for the purpose of describing particular embodiments and/or features or components thereof, and is not intended to be limiting. Various modifications, changes, enhancements and/or variations in form and/or detail can be made without departing from the scope of the disclosure and/or without altering the function and/or advantages thereof, unless otherwise explicitly stated. Functionally equivalent examples, implementations, and/or methods other than those enumerated herein will be apparent to those skilled in the art from the foregoing description, and are intended to fall within the scope of the present disclosure.

For example, while prosthetic valves are described herein as being used with a particular native valve and clip configuration, it should be understood that they have been presented by way of example only, and not limitation. The embodiments and/or apparatus described herein are not limited to any particular implementation unless explicitly stated otherwise.

Where the schematic, examples, and/or implementations described above indicate particular components arranged and/or configured in particular directions or locations, the arrangement of components may be modified, adjusted, optimized, etc. The particular dimensions and/or particular shapes of the various components may be different from the illustrated embodiments while still providing the functionality as described herein. More specifically, the size and shape of the various components may be specifically selected for the desired or intended use. Thus, it should be understood that the size, shape and/or arrangement of the embodiments and/or components thereof may be adapted for a given use unless the context clearly indicates otherwise. As an example, in some embodiments, a treatment device intended to provide treatment to an adult user may have a first size and/or shape, while a treatment apparatus intended to provide treatment to a child user may 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 treatment device may cause certain components to be moved, redirected, and/or rearranged while maintaining the desired functionality of the device.

Although various embodiments have been described as having particular features, functions, components, elements and/or characteristics, other embodiments may have any combination and/or sub-combination of features, functions, components, elements and/or characteristics from any one of the embodiments described herein, unless a mutually exclusive combination or otherwise explicitly specified. Furthermore, unless expressly stated otherwise herein, any particular combination of elements, functions, features, elements, etc. may be separated and/or separated into individual elements, functions, features, elements, etc. or may be integrated into a single or unitary element, function, feature, element, etc.

When the above-described method indicates that particular events occur in a particular order, the order of the particular events may be modified. Furthermore, certain events may be performed concurrently in a parallel process, if possible, as well as sequentially as described above. Although methods have been described as having particular steps and/or combinations of steps, other methods may also have any combination of steps from any of the methods described herein, unless a combination is mutually exclusive and/or unless the context clearly dictates otherwise.

Claims

1. A prosthetic valve, comprising:

a body comprising an inlet portion and an outlet portion having a first flap and a second flap, and defining a flow channel having an inlet in the inlet portion, a first outlet in the first flap, and a second outlet in the second flap;

a flow control device disposed in the flow channel within the inlet portion 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 inhibit fluid from flowing through the flow channel in a second direction opposite the first direction; and

a clip connector coupled to the body;

the prosthetic valve is configured to be disposed in a native valve of a heart, wherein a first leaflet has been coupled to a second leaflet by a clip, a first flow control is defined between the first leaflet, the second leaflet, and the clip, and a second flow control is defined between the first leaflet, the second leaflet, and the clip, the inlet is disposed in an atrium of the heart, and the first outlet and the second outlet are disposed in a ventricle of the heart;

The first leaflet is configured to be disposed in the first flow control portion in substantially sealing relation to the first leaflet and the second leaflet, the second leaflet is configured to be disposed in the second flow control portion in substantially sealing relation to the first leaflet and the second leaflet;

the prosthetic 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 first and second outlets during diastole and to substantially prevent blood from flowing from the ventricle to the atrium through the flow channel or between the body and the leaflet during systole, an

The clip connector is configured to selectively couple to the clip and resist displacement of the body toward the atrium during contraction.

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.

3. The prosthetic valve of claim 2, wherein the annulus connector comprises 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 an annulus of the native heart valve.

4. The prosthetic valve of claim 3, wherein the annulus connector comprises 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 an annulus of the native heart valve.

5. The prosthetic valve of claims 1-3, wherein the valve annulus connector is configured to engage an atrial side of the native valve annulus.

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

7. The prosthetic valve of claim 1, further comprising a heart tissue tether coupled to any 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 hydrodynamic loads exerted on the prosthetic valve during a cardiac cycle to the heart tissue to help hold the prosthetic valve in a desired position in the native heart valve.

8. The prosthetic valve of claims 1-7, wherein the flow control device is a tri-leaflet valve.

9. The prosthetic valve of claims 1-7, wherein the flow control device comprises a valve frame, a first tissue leaflet coupled to the valve frame, a second tissue leaflet coupled to the frame and disposed radially opposite the first tissue leaflet, each tissue leaflet She Mianxiang about one third of a periphery of the valve frame, a first static half-cusp coupled to the valve frame between the first tissue leaflet and the second tissue leaflet, and a second static half-cusp coupled to the valve frame between the first tissue leaflet and the second tissue leaflet and radially opposite the first static half-cusp, each static half-cusp facing about one sixth of the periphery of the valve frame; the tissue leaflet can sealingly engage the static half-cusps to prevent fluid flow therebetween in a first direction and to permit fluid flow therebetween in a second direction opposite the first direction.

10. The prosthetic valve of claim 9, wherein each static half-cusp comprises a static cusp frame coupled to the valve frame and a static cusp supported on the static cusp frame and disposed in sealing engagement with the tissue leaflet.

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

12. The prosthetic valve of claim 1, wherein the body comprises a body cover, each of the first and second petals comprising a leaflet contact region against which the native leaflet can sealingly engage when the petals are disposed in the flow control portion, the body cover at least in the leaflet contact region being formed of tissue.

13. The prosthetic valve of claim 12, wherein the body comprises a body frame having a stent-frame wire configuration for portions of the body that are not leaflet contact regions, the body frame having less structural rigidity in a radial direction in a leaflet contact region such that the body cover is relatively more compliant so that it applies less stress to a native leaflet contacting the leaflet contact region.

14. The prosthetic valve of claim 1, wherein each of the first and second flaps comprises an outlet cuff at an outlet end thereof, the outlet cuff comprising a filler material to reduce the risk of cardiac tissue injury that may contact the outlet end of the flap.

15. The prosthetic valve of claim 1, 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, and comprising a plurality of radial valve posts coupled at a lower end thereof to a second end of the axial clip post and coupled at an upper end thereof to a frame of the flow control device.

16. The prosthetic valve of claim 15, wherein the radial valve struts are disposed on a ventricular side of a commissure line of tissue leaflets, the tissue leaflets She Shezhi being in the flow control device.

17. A prosthetic valve, comprising:

a body including an inlet portion and an outlet portion and defining a flow passage; the flow channel has an inlet in the inlet portion and an outlet portion;

a flow control device disposed in the flow channel within the inlet portion 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 the first direction; and

A clip connector coupled to the body,

the prosthetic valve is configured to be disposed in a native valve of a heart, wherein a first leaflet has been 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 an atrium of the heart, and the outlet is disposed in a ventricle of the heart;

the outlet portion is configured to be disposed in the flow control portion in substantially sealing relation to the first and second leaflets;

the prosthetic 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 to substantially prevent blood from flowing from the ventricle to the atrium through the flow channel or between the body and the leaflet during systole, an

18. The prosthetic valve of claim 17, 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.

19. The prosthetic valve of claim 18, wherein the annulus connector comprises 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 an annulus of the native heart valve.

20. The prosthetic valve of claim 19, wherein the annulus connector comprises 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 an annulus of the native heart valve.

21. The prosthetic valve of claims 17-19, wherein the valve annulus connector is configured to engage an atrial side of the native valve annulus.

22. The prosthetic valve of claims 17-19, wherein the valve annulus connector is configured to engage a ventricular side of the native valve annulus.

23. The prosthetic valve of claim 17, further comprising a heart tissue tether coupled to any 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 hydrodynamic loads exerted on the prosthetic valve during a cardiac cycle to the heart structure to help hold the prosthetic valve in a desired position in the native heart valve.

24. The prosthetic valve of claims 17-23, wherein the flow control device is a tri-leaflet valve.

25. The prosthetic valve of claim 17, 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, and 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 channel 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 the heart, wherein the first leaflet has been coupled to the second leaflet by a second clip or the first leaflet has been 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.

26. The prosthetic valve of claim 17, 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.

27. The prosthetic valve of claim 17, wherein the atrioventricular valve is a mitral valve, the first leaflet is an anterior leaflet, and the second leaflet is a posterior leaflet.

28. The prosthetic valve of claim 27, wherein the clip is coupled to a central portion of each of the anterior leaflet and the posterior leaflet, the first flow control portion being defined between the anterior leaflet, the posterior leaflet, a posterolateral commissure of the mitral valve, and the clip, and the second flow control portion being defined between the anterior leaflet, the posterior leaflet, a anterolateral commissure of the mitral valve, and the clip, the first and second flow control portions having substantially equal flow areas.

29. The prosthetic valve of claim 27, wherein the clip is eccentrically coupled to the anterior leaflet and the posterior leaflet, the first flow control portion being defined between the anterior leaflet, the posterior leaflet, a posterolateral commissure of the mitral valve, and the clip, and a second flow control portion being defined 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 larger flow area than a flow area of the second flow control portion.

30. A method of repairing a native atrioventricular valve having a first leaflet coupled to a second leaflet by a clip, the native atrioventricular valve defining a first flow control portion between the first leaflet, the second leaflet and the clip and a second flow control portion between the first leaflet, the second leaflet and the clip, the method comprising:

delivering a prosthetic valve to the native atrioventricular valve; the prosthetic valve has a body including an inlet portion and an outlet portion having first and second petals, and the body defines a flow channel having an inlet in the inlet portion, a first outlet in the first petal, and a second outlet in the second petal; and the prosthetic valve has a flow control device and a clip connector coupled to the body; the flow control device is disposed in the flow channel within the inlet portion and is 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 inhibit fluid from flowing through the flow channel in a second direction opposite the first direction;

Disposing a prosthetic valve in a native atrioventricular valve, wherein an inlet is disposed in an atrium of a heart and first and second outlets are disposed in a ventricle of the heart, wherein the first valve is disposed in the first flow control portion in substantially sealing relationship with the first and second valve leaflets; and disposing the second flap in the second flow control portion in substantially sealing relationship with the first and second leaflets; and

the clip connector is coupled to the clip.

31. The method of claim 30, wherein the prosthetic valve comprises an annulus connector coupled to the body, further comprising engaging the annulus connector with an annulus of the native atrioventricular valve.

32. The method of claim 31, wherein engaging the annulus connector comprises engaging one or both of an atrial side of the native valve annulus and a ventricular side of the native valve annulus.

33. The method of claim 30, wherein the prosthetic valve comprises a heart tissue tether coupled to the body and having a tissue anchor at a distal end thereof, further comprising securing the tissue anchor to heart tissue of the heart.

34. The method of claims 30-33, further comprising delivering the clip to the native atrioventricular valve and securing the clip to the native leaflet to create the first and second flow controls prior to delivering the prosthetic valve.

35. A method of repairing a native atrioventricular valve having a first leaflet coupled to a second leaflet by a clip, the native atrioventricular valve defining a flow control portion between the first leaflet, the second leaflet and the clip, the method comprising:

delivering a prosthetic valve to the native atrioventricular valve; the prosthetic valve has a body including an inlet portion and an outlet portion, and the body defines a flow passage having an inlet in the inlet portion, an outlet in the outlet portion; and the prosthetic valve having a flow control device disposed in the flow channel within the inlet portion and configured to permit fluid flow through the flow channel in a first direction from the inlet to the outlet and inhibit fluid flow through the flow channel in a second direction opposite the first direction; and the prosthetic valve has a clip connector coupled to the body;

Disposing a prosthetic valve in a native atrioventricular valve, the inlet disposed in an atrium of the heart, and the outlet disposed in a ventricle of the heart, wherein the outlet portion is disposed in the flow control portion in substantially sealing relationship with the first leaflet and the second leaflet; and

the clip connector is coupled to the clip.

36. The method of claim 35, wherein the prosthetic valve comprises an annulus connector coupled to the body, further comprising engaging the annulus connector with an annulus of the native atrioventricular valve.

37. The method of claim 36, wherein engaging the annulus connector comprises engaging one or both of an atrial side of the native valve annulus and a ventricular side of the native valve annulus.

38. The method of claim 35, wherein the prosthetic valve comprises a heart tissue tether coupled to the body and having a tissue anchor at a distal end thereof, further comprising securing the tissue anchor to heart tissue of the heart.

39. The method of claims 35-38, further comprising delivering the clip to the native atrioventricular valve and securing the clip to the native leaflet to create the first and second flow controls prior to delivering the prosthetic valve.