Methods, devices, and apparatuses for treating heart valves

Abstract

An apparatus for treating blood flow regurgitation through a native heart valve (16) includes a selective occlusion device sized and configured to be implanted in the native heart valve (16) and to selectively operate with at least one of a first native leaflet or a second native leaflet (16a, 16b) to allow blood flow through the native heart valve (16) when a cardiac cycle is in a diastolic phase and to reduce blood flow regurgitation through the native heart valve (16) when the cardiac cycle is in a systolic phase. A clip structure (50) is coupled with the selective occlusion device. The clip structure (50) is configured to attach to an edge of at least one of the first native leaflet or the second native leaflet (16a, 16b) to secure the selective occlusion device to the native heart valve (16).

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 627,894 filed on February 8, 2018 (pending) and U.S. Provisional Patent Application Serial No. 62 / 671,077 filed on May 14, 2018 (pending), the disclosures of which are incorporated herein by reference in their entireties. Technical Field

[0003] The present disclosure relates generally to ways of treating heart valves, and more particularly to ways of reducing regurgitation of blood flow through a heart valve, thereby improving the efficiency and function of the heart valve. Background Art

[0004] Heart valve insufficiency, which takes various forms and affects various heart valves, such as the aortic, tricuspid, pulmonary, and mitral valves, has led to an expanding field of research and development aimed at improving heart valve function. While any one or more of these natural heart valves may be impaired due to, for example, congenital disease or more common disease conditions, the mitral valve has received particular attention. Regurgitation of blood flow through a heart valve, such as the mitral valve, involves the backward flow of blood through the valve when the valve should be fully closed (i.e., complete coaptation of the native leaflets). When the mitral valve is diseased or damaged, it typically allows regurgitated blood to flow from the left ventricle into the left atrium during systole. This results in a reduced amount of blood being ejected from the left ventricle during systole, resulting in a less-than-optimal "ejection fraction" for the patient. As a result, the patient may experience a lower quality of life due to an inefficient heart or, worse, a life-threatening condition.

[0005] Surgical techniques as well as transvascular or catheter-based techniques have been developed for treating mitral valve insufficiency and include, for example, mitral annuloplasty, attaching the native anterior mitral valve leaflet to the native posterior mitral valve leaflet, cord replacement and even complete mitral valve replacement.

[0006] In many cases, mitral regurgitation is not related to a congenital defect in the mitral valve leaflets, but rather to changes in the coaptation of the leaflets over time due to heart disease. In these cases, the native mitral valve leaflets are often relatively normal, but they still cannot prevent blood from flowing back from the left ventricle into the left atrium during systole. Instead of the native anterior and posterior leaflets fitting together properly or fully coapting during contraction or systole, one or more gaps between the native leaflets lead to mitral regurgitation.

[0007] Current commonly used techniques for reducing mitral regurgitation include using a clip structure to attach the native mitral valve anterior leaflet to the native mitral valve posterior leaflet. The clip structure is used to firmly affix the central points on the edges of the anterior and posterior leaflets together. This results in the mitral valve being essentially divided into two flow control portions, each on either side of the clip structure. The clip structure can take a simple form that directly clips the anterior and posterior leaflets together at the central locations on each leaflet edge to bring them into contact with each other, or it can include spacers, each leaflet being clipped to the spacer, for example, by a wider paddle structure. In either case, the clip structure firmly holds the mitral valve leaflets together in a manner that withstands the cyclic forces of the heart.

[0008] When the native anterior and posterior mitral valve leaflets are affixed together at approximately the center of the valve, i.e., at the A2 and P2 locations of the native leaflets, persistent leakage can still exist on one or both sides of the clip, which results in regurgitation.

[0009] It would be useful to further address these and other issues or challenges associated with heart valve insufficiency. SUMMARY

[0010] In a first example embodiment, an apparatus for treating blood flow regurgitation through a native heart valve including a first native valve leaflet and a second native valve leaflet is provided, the apparatus generally including a selective occlusion device and a clip structure. The selective occlusion device is sized and configured to be implanted in the native heart valve and to selectively operate with at least one of the first native valve leaflet or the second native valve leaflet to allow blood flow through the native heart valve when a cardiac cycle is in a diastolic phase and to reduce blood flow regurgitation through the native heart valve when the cardiac cycle is in a systolic phase. The clip structure is coupled with the selective occlusion device. The clip structure is configured to affix to an edge of at least one of the first native valve leaflet or the second native valve leaflet to secure the selective occlusion device to the native heart valve.

[0011] Various other additional and / or optional features are provided, some examples of which are summarized below. The clip structure can include a clip comprised of a pair of clip elements. At least one of the clip elements is movable between an open position and a closed position. The clip elements capture native leaflet tissue between the clip elements in the closed position. The clip structure can optionally or additionally include a first clip and a second clip, each first and second clip including a pair of clip elements. At least one of each pair of clip elements is movable relative to the other of each pair of clip elements between an open and a closed position. The first clip can be configured to attach a first native leaflet to the selective occlusion device, and the second clip can be configured to attach a second native leaflet to the selective occlusion device. As another option, a single clip structure can be used between opposing native leaflets, e.g., about a central position between the anterior and posterior native leaflets of a native mitral valve, and the single clip structure can simultaneously capture leaflet tissue of the anterior and posterior leaflets. It will be appreciated that aspects and features discussed herein apply to any native heart valve, including the pulmonary valve, the tricuspid valve, the aortic valve, and the mitral valve. To understand the general principles, the example embodiments are described in connection with treating a native mitral valve.

[0012] As further optional and / or additional features, for example, the selective occlusion device can further include a prosthetic heart valve including a moveable valve element configured to selectively control blood flow through the native heart valve. The moveable valve element can further include a flexible membrane configured to engage at least one of the first native leaflet or the second native leaflet of the native heart valve when the cardiac cycle is in systole and disengage the at least one of the first native leaflet or second native leaflet when the cardiac cycle is in diastole. The flexible membrane can further include a closed end and an open end. The open end receives blood flow when the cardiac cycle is in systole to cause the membrane to expand to engage the first native leaflet and the second native leaflet in systole, and the open end closes to allow blood flow between the membrane and the first native leaflet and second native leaflet when the cardiac cycle is in diastole.

[0013] As another optional and / or additional feature, some embodiments can include a frame structure coupled with the clip structure. The annulus connector, and preferably the non-penetrating annulus connector, is coupled with the frame structure. The annulus connector is configured to engage heart tissue without penetrating the tissue. In some embodiments, the frame structure is configured to extend generally across the native heart valve between the commissures, and the selective occlusion device is generally secured in place between the clip structure and the annulus connector. The frame structure can extend across the native heart valve at a location other than or different from the commissure locations. Also in some embodiments, the one or more annulus connectors provide a first force against the heart tissue generally at the annulus, and the clip structure provides an opposing second force (relative to the first force) at a lower edge of at least one of the first or second rings to generally hold the selective occlusion device between the annulus connector and the clip structure.

[0014] In some embodiments, the clip structure includes a pair of clip elements movable between an open position and a closed position, and the clip elements capture native leaflet tissue between the clip elements in the closed position and can allow the leaflet tissue to directly engage or indirectly abut against a spacer positioned between the leaflet tissue in an abutting manner (e.g., from an anterior leaflet to a posterior leaflet). In particular, the spacer can be installed between the pair of clip elements and the native leaflet tissue is engaged between the respective clip elements and the spacer. Also, in some embodiments, the selective occlusion device can further include one or more rigid selective occlusion elements sized and configured to be implanted into the native heart valve such that, when the cardiac cycle is in systole, at least one of the first or second native leaflets engages the rigid element to reduce blood flow regurgitation through the native heart valve, and when the cardiac cycle is in diastole, at least one of the first or second native leaflets disengages the rigid element to allow blood flow through the native heart valve. In some embodiments, the selective occlusion device further includes a first selective occlusion element and a second selective occlusion element sized and configured to be implanted into the native heart valve such that, when the cardiac cycle is in systole, at least one of the first or second native leaflets engages the first and second selective occlusion elements to reduce blood flow through the native heart valve, and when the cardiac cycle is in diastole, the at least one of the first or second native leaflets disengages the first and second selective occlusion elements to allow blood flow through the native heart valve. The selective occlusion elements can be rigid. The term "rigid" is not intended to mean that the selective occlusion device does not have flexibility, but only that the selective occlusion device in these embodiments does not need to rely on active movement to engage and / or disengage the flexible membrane of one or more native leaflets. In other words, the one or more selective occlusion elements can be static in operation.

[0015] In some embodiments, the apparatus further includes at least one catheter carrying the selective occlusion device and / or the clip structure and / or the frame structure. It should be appreciated that the catheter or transvascular delivery system can include the use of multiple catheters. The one or more catheters are configured to deliver the selective occlusion device and / or the clip structure and / or the frame structure to the site of the native heart valve. The selective occlusion device can have a collapsed state designed for transvascular delivery and a deployed state for implantation into the native heart valve. Likewise, the frame structure can have a collapsed state for delivery through the at least one catheter and a deployed state for implantation into the native heart valve.

[0016] In another example embodiment, an apparatus for treating blood flow regurgitation through a native heart valve including a first native leaflet and a second native leaflet is provided that generally includes a selective occlusion device coupled with a frame structure. More particularly, the selective occlusion device can be configured in any of the ways contemplated herein, such as any of the ways outlined above. The frame structure is coupled with at least one non-penetrating annulus connector, and the annulus connector is configured to engage with heart tissue without penetrating the tissue. The frame structure is configured to extend through the native heart valve generally supported by the annulus, and the selective occlusion device is generally secured in place between the frame structure and the annulus connector. For example, in some embodiments, the annulus connector can be an annular element configured to sit substantially on top of the annulus of the mitral valve in the left atrium of the native heart. In other embodiments, multiple annulus connectors can be utilized. For example, first and second annulus connectors can be used at or positioned at annulus heights that abut respective commissures of the mitral valve, or at other generally opposite locations along the native valve annulus. It will be appreciated that any of the features discussed and / or contemplated thereby can be combined together for advantageous results.

[0017] In other example aspects, methods for treating blood flow regurgitation through a native heart valve are provided. In some example methods, the method includes delivering a selective occlusion device into a native heart valve between a first native leaflet and a second native leaflet. A clip structure is delivered proximate to an edge of at least one of the first native leaflet or the second native leaflet. The clip structure is secured to the edge of at least one of the first native leaflet or the second native leaflet. The selective occlusion device is secured to the clip structure, and then the selective occlusion device is used to operate with at least one of the first native leaflet or the second native leaflet to allow blood flow through the native heart valve when a cardiac cycle is in a diastolic phase and to reduce blood flow regurgitation through the native heart valve when the cardiac cycle is in a systolic phase.

[0018] As with the other aspects and exemplary embodiments, various additional and / or optional features of the method may be employed. The clip structure may further include a clip comprised of a pair of clip elements, and attaching the clip structure may further include moving at least one of the clip elements between an open and a closed position and capturing native leaflet tissue between the clip elements in the closed position. In some embodiments, the clip structure may further include a first clip and a second clip, the first clip and the second clip each including a pair of clip elements, at least one of each pair of clip elements being movable between an open position and a closed position relative to the other of each pair of clip elements. Attaching the clip structure may further include attaching the first clip to the first native leaflet and the selective occlusion device, and attaching the second clip to the second native leaflet and the selective occlusion device. The selective occlusion device may further include a prosthetic heart valve including a movable valve element, and using the selective occlusion device may further include selectively controlling blood flow through the native heart valve by moving the movable valve element between an open position and a closed position. In some embodiments, the movable valve element may further include a flexible membrane, and using the selective occlusion device may further include engaging at least one of the first or second natural leaflets of the natural heart valve with the flexible membrane when the cardiac cycle is in systole to reduce blood backflow through the natural heart valve, and disengaging at least one of the first or second natural leaflets from the flexible membrane to allow blood to flow through the natural heart valve when the cardiac cycle is in diastole. In some embodiments, the method includes engaging the first and second natural leaflets of the natural heart valve with the flexible membrane when the cardiac cycle is in systole to reduce blood backflow through the natural heart valve, and disengaging the first and second natural leaflets from the flexible membrane to allow blood to flow through the natural heart valve when the cardiac cycle is in diastole. The flexible membrane may include a closed end and an open end. Engaging the first and second natural leaflets may further include receiving blood flow through the open end to expand the membrane into engagement with the first and second natural leaflets when the cardiac cycle is in the systole phase; and the step of disengaging the first and second natural leaflets may include closing the open end when the cardiac cycle is in the diastole phase to allow blood to flow between the membrane and the first and second natural leaflets.

[0019] The method can further include coupling the frame structure with the clip structure. The non-penetrating annulus connector can engage with heart tissue proximate the native heart valve annulus, and the frame structure can span the native valve and be secured to the non-penetrating annulus connector such that the selective occlusion device is generally secured in place between the clip structure and the non-penetrating annulus connector. In some embodiments, a first force can be exerted on the heart tissue by the annulus connector, and a second, opposing force can be provided by the clip structure at a lower edge of at least one of the first native leaflet or the second native leaflet to hold the selective occlusion device between the annulus connector and the clip structure. For example, the forces can be a pushing force and a pulling force. Also in some embodiments, the method can utilize a pair of clip elements as the clip structure, and at least one of the clip elements can be movable between an open position and a closed position, and the affixing the clip structure can further include capturing native leaflet tissue between the clip elements and the spacer when the at least one clip element is moved to the closed position. In other embodiments, the clip structure brings abutting leaflet tissue into direct contact when the clip is closed. Also in some embodiments, the selective occlusion device can further include a rigid element, as generally discussed herein, and the rigid element of the selective occlusion device is engaged with at least one of the first native leaflet or the second native leaflet when the cardiac cycle is in systole to reduce blood flow regurgitation through the native heart valve, and the rigid element is disengaged from at least one of the first native leaflet or the second native leaflet when the cardiac cycle is in diastole to allow blood to flow through the native heart valve between the rigid element and at least one of the first native leaflet or the second native leaflet.

[0020] In various exemplary embodiments of the method, the selective occlusion device and / or clip structure and / or frame structure and other components used in the method can be delivered and implanted transluminally. For example, the selective occlusion device can be guided through at least one catheter with or without the clip structure, with the selective occlusion device in a collapsed state. The selective occlusion device is extruded from a distal end of the at least one catheter, and the device is deployed in a native heart valve. The method can also include delivering a frame structure transluminally to the native heart valve, delivering the clip structure transluminally to the native heart valve, and engaging a non-penetrating annulus connector with heart tissue proximate to an annulus of the native heart valve. The frame structure can be secured across the native heart valve and to the non-penetrating annulus connector such that the selective occlusion device is substantially fixed in place between the clip structure and the non-penetrating annulus connector. In another optional and / or additional aspect, the method can further include delivering a clip structure capture device transluminally, capturing the clip structure using the capture device, and connecting the clip structure to the frame structure during implantation of the selective occlusion device in the native heart valve.

[0021] In another exemplary method for treating blood flow regurgitation through a native heart valve including at least a first native leaflet and a second native leaflet, the method includes delivering a selective occlusion device into the native heart valve between the first and second native leaflets. A frame structure is delivered proximate to the native heart valve. The frame structure is affixed to an annulus of the native heart valve by a non-penetrating annulus connector. The selective occlusion device is secured to the frame structure. The selective occlusion device is then used to operate with at least one of the first or second native leaflets to allow blood flow through the native heart valve when a cardiac cycle is in a diastolic phase and to reduce blood flow regurgitation through the native heart valve when the cardiac cycle is in a systolic phase. Any other and / or optional features summarized, discussed, or otherwise contemplated herein can be used to perform this general method.

[0022] In another example embodiment, an apparatus for treating blood flow regurgitation through a native heart valve including a first native leaflet and a second native leaflet is provided, the apparatus generally comprising a prosthetic heart valve and a clip structure. More particularly, the prosthetic heart valve includes a peripheral, generally cylindrical frame movable between a collapsed state and a deployed state, and a plurality of prosthetic leaflets secured within the peripheral, generally cylindrical frame, the prosthetic leaflets movable between the open state and a closed state to control blood flow through the prosthetic heart valve, respectively. The frame is implanted by deployment relative to the first and second native leaflets of the native heart valve. The clip structure is coupled with the frame of the prosthetic heart valve. The clip structure is configured to attach to an edge of at least one of the first or second native leaflets to secure the prosthetic heart valve to the native heart valve. As an optional and / or additional aspect, the clip structure can further comprise a first clip and a second clip, each clip including a pair of clip elements, and at least one of each pair of clip elements is movable relative to the other clip element of each pair between an open position and a closed position. The first clip is configured to attach the first native leaflet to the prosthetic heart valve, while the second clip is configured to attach the second native leaflet to the prosthetic heart valve. The prosthetic heart valve can take any desired form, one example being an expandable stent structure including a frame.

[0023] As another example method, a prosthetic heart valve is delivered through a blood vessel in a collapsed state to a space within the native heart valve. The prosthetic heart valve is clipped to the first and second native leaflets by capturing edges of the first and second native leaflets between respective clip elements. The prosthetic heart valve is deployed relative to the first and second native leaflets, and blood flow through the native heart valve is controlled by movement of the prosthetic leaflets of the prosthetic heart valve. As an optional and / or additional feature of this method, clipping the prosthetic heart valve can further comprise capturing an anterior leaflet of the native mitral valve with a first clip, and capturing a posterior leaflet of the native mitral valve with a second clip.

[0024] In another example embodiment, an apparatus for treating blood flow regurgitation through a native heart valve including a first native leaflet and a second native leaflet generally includes a selective occlusion device and a clip structure capture device. The selective occlusion device is sized and configured to be implanted in the native heart valve and to selectively operate with at least one of the first or second native leaflets to allow blood flow through the native heart valve when a cardiac cycle is in a diastolic phase and to reduce blood flow regurgitation through the native heart valve when the cardiac cycle is in a systolic phase. The clip structure capture device is expandable from at least one catheter and configured to capture a clip structure or other anchor that secures the first and second native leaflets to each other to allow the clip structure or other anchor to be coupled with the selective occlusion device. The clip structure capture device can further include a snare or suture loop device. The at least one catheter can carry the selective occlusion device and the clip structure capture device. In this case, the at least one catheter is configured to deliver the selective occlusion device and the clip structure capture device to a site of the native heart valve, and the selective occlusion device has a collapsed state for delivery through the at least one catheter and a deployed state for implantation in the native heart valve. It will be appreciated that different components can be carried and delivered in different catheters. In this embodiment, any other features or aspects of the present disclosure can additionally or alternatively be used.

[0025] In another example method, blood flow regurgitation through a native heart valve including a first native leaflet and a second native leaflet can be treated by capturing a clip structure or other anchor secured to an edge of at least one of the first or second native leaflets. While capturing the clip structure or other anchor, a selective occlusion device is delivered into the native heart valve between the first and second native leaflets and secured to the clip structure or other anchor. The selective occlusion device is used to operate with at least one of the first or second native leaflets to allow blood flow through the native heart valve when a cardiac cycle is in a diastolic phase and to reduce blood flow regurgitation through the native heart valve when the cardiac cycle is in a systolic phase. Capturing the clip structure can further include entrapping the clip structure with a tension member. Securing the selective occlusion device can further include attaching the tension member between the clip structure and the selective occlusion device. Securing the selective occlusion device can further include attaching the clip structure to a frame member of the selective occlusion device. Again, the method can additionally or alternatively include other features or aspects contemplated by the methods disclosed or envisioned herein.

[0026] In another example embodiment, a selective occlusion device is provided for assisting in controlling blood flow through a native heart valve including a first native leaflet and a second native leaflet. The selective occlusion device is sized and configured to be implanted in the native heart valve proximate to a clip structure that divides the native heart valve into at least two inner valve portions between the first and second native leaflets and two outer valve portions behind the first and second native leaflets. Generally, the selective occlusion device can be implanted on, for example, at least one side of the clip structure that secures the two native leaflets of the heart valve together and thereby substantially bisects the native valve into two inner portions through which blood will flow through the valve and two outer portions outside (i.e., behind) the leaflets. The selective occlusion device can control blood flow in any desired manner, including, for example, as one or more of the manners contemplated herein.

[0027] In another example method, a selective occlusion device is delivered into the native heart valve between the first and second native leaflets and on at least one side of a clip structure that divides the native heart valve into at least two inner valve portions between the first and second native leaflets and two outer valve portions behind the first and second native leaflets. The selective occlusion device is used to assist in controlling blood flow through the native heart valve during a cardiac cycle. Again, the selective occlusion device can control blood flow in any desired manner, including, for example, as one or more of the manners contemplated herein.

[0028] Additional features, aspects and / or advantages will be recognized and appreciated upon further review of the detailed description of the example embodiments, taken in BRIEF DESCRIPTION OF DRAWINGS

[0029] Figure 1A is a schematic diagram showing a system configured in accordance with one example embodiment.

[0030] Figure 1B is a schematic perspective view of a native left atrium and mitral valve similar to Figure 1A but showing installation of a catheter-delivered selective occlusion device.

[0031] Figure 1C is a schematic perspective view similar to Figure 1B but showing the membrane of the selective occlusion device in place on the frame structure.

[0032] Figure 2A is a cross-sectional view through the selective occlusion device along line 2A-2A of Figure 3A when the cardiac cycle is in systole.

[0033] Figure 2B is a cross-sectional view similar to Figure 3A but taken along the line 2B-2B during the systolic phase of the cardiac cycle. Figure 2A

[0034] Figure 2C is a cross-sectional view similar to Figure 2B but showing the native mitral valve and the selective occlusion device in the diastolic phase of the cardiac cycle.

[0035] Figure 3A is a top view of the native mitral valve and the selective occlusion device when the heart is in the systolic phase.

[0036] Figure 3B is a top view similar to Figure 3A but showing the device and the native mitral valve when the heart is in the diastolic phase.

[0037] Figure 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.

[0038] Figure 4B is a perspective view similar to Figure 4A but showing the membrane applied to the frame structure of the device.

[0039] Figure 5A is a schematic perspective view similar to the partially cross-sectional view of Figure 1A but showing a catheter- or trans-catheter based delivery and implantation system configured according to another embodiment.

[0040] Figure 5B is a view similar to Figure 5A but showing a subsequent step in the method in which the native mitral valve leaflets have been captured and pinched together.

[0041] Figure 5C is a cross-sectional view similar to Figure 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.

[0042] Figure 5D is a view similar to Figure 5C but showing the flexible membrane of the device in place on the frame structure.

[0043] Figure 6A is a perspective view of the frame structure and attached clip structure as shown in Figures 5A to 5C

[0044] Figure 6B ​​is a perspective view similar to Figure 6A but showing another embodiment of the collapsible and deployable frame structure.

[0045] Figure 7A is a cross-sectional view of the native mitral valve and the selective occlusion device of Figure 6B and the heart is in diastolic phase.

[0046] Figure 7B is a cross-sectional view similar to Figure 7A but showing the selective occlusion device and the mitral valve when the heart is in systolic phase.

[0047] Figure 8 is a side view and a cross-section of the heart at the location of the native mitral valve showing the selective occlusion device, for clarity the membrane is shown in dashed lines, and the device is implanted.

[0048] Figure 9 is a perspective view showing another embodiment of the selective occlusion device, for clarity the frame structure is shown in solid lines and the flexible membrane is shown in dashed lines.

[0049] Figure 10A is a schematic perspective view similar to Figure 1A and 5A but showing another embodiment of the catheter-based system for delivering and implanting the selective occlusion device coupled with a pre-installed mitral valve leaflet clip structure.

[0050] Figure 10B is a view similar to Figure 10A but showing a subsequent step during the method.

[0051] Figure 10C is a perspective view and the heart is cut open at the native mitral valve showing the implantation of the selective occlusion device but for clarity the flexible membrane is removed.

[0052] Figure 11A is a perspective view showing another alternative embodiment of the selective occlusion device with the flexible membrane removed for clarity.

[0053] Figure 11B is a perspective view showing another alternative embodiment of the selective occlusion device with the flexible membrane removed for clarity.

[0054] Figure 11C is a front top perspective view of the device of Figure 11A or 1 IB implanted in the native mitral valve.

[0055] Figure 11D is a front view of the device in Figures 11A to 11C .

[0056] Figure 11E is a lateral cross-section of Figure 11D

[0057] Figure 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.

[0058] Figure 12B is a cut-away view of a heart taken at a native mitral valve and showing a selective occlusion device of Figure 12A

[0059] is a view similar to Figure 12C but showing another alternative embodiment of a selective occlusion device implanted in a native mitral valve. Figure 12B

[0060] is another view similar to Figure 12D but showing another alternative embodiment of a selective occlusion device implanted in a native mitral valve. Figure 12C

[0061] is a cross-sectional view taken through one of the selective occlusion elements across the mitral valve and generally across Figure 13A to show sealing during systole. 12A to 12D

[0062] is a view similar to Figure 13B but showing the selective occlusion elements and the mitral valve when the heart is in diastolic phase. Figure 13A

[0063] is a view similar to Figure 13C but showing another embodiment of a selective occlusion element. Figure 13B

[0064] is a perspective view of another alternative embodiment of a selective occlusion device and mitral clip structure. Figure 14A

[0065] is a perspective view of another alternative embodiment of a selective occlusion device and mitral clip structure. Figure 14B

[0066] is a perspective view of another alternative embodiment of a selective occlusion device and mitral clip structure. Figure 14C

[0067] is a perspective view of another alternative embodiment of a selective occlusion device, with the flexible membrane of the device broken away for clarity. Figure 15A

[0068] Figure 15B ​​is a perspective view similar to Figure 15A but further showing the flexible membrane on the frame structure.

[0069] Figure 15C is a perspective view similar to Figure 15A and 15B but with the flexible membrane removed for clarity.

[0070] Figure 15D is a side view similar to Figure 15C but showing the flexible membrane applied to the frame structure.

[0071] Figure 15E is a top view of the device shown in Figures 15A to 15D but showing a cross section of the membrane to show the membrane shape in an expanded or filled state when the heart is in a systolic phase.

[0072] Figure 16A is a perspective view of the system and heart similar to Figure 5A but showing another alternative embodiment of the catheter-based system and method for implanting a selective occlusion device and clip structure into a native mitral valve.

[0073] Figure 16B is a perspective view similar to Figure 16A but showing a subsequent step in the method.

[0074] Figure 16C is a view similar to Figure 16B but showing another subsequent step in the method.

[0075] Figure 16D is a perspective view showing an implanted selective occlusion device in a patient's mitral valve.

[0076] Figure 17A is a side cutaway view of a native mitral valve and 16A to 16D a selective occlusion device implanted and secured to a mitral clip structure.

[0077] Figure 17B is a side cutaway view similar to Figure 17A but showing a subsequent step in the method.

[0078] Figure 17C is a side cutaway view similar to Figure 17B but showing another subsequent step in the method in which the device is fully implanted.

[0079] Figure 18A is a perspective view similar to Figures 16A to 16DCross-sectional view of the selective occlusion device shown in 17A to 17C, and showing the device and the mitral valve when the heart is in diastolic phase.

[0080] Figure 18B is a view similar to Figure 18A but showing the device and the native mitral valve when the heart is in systolic phase.

[0081] Figure 19 is a top view schematically showing an illustration of the shape of the selective occlusion device when implanted into a native mitral valve having an anatomical curvature.

[0082] Figure 20 is a perspective view of a selective occlusion device configured according to another alternative embodiment.

[0083] Figure 21A is a side cross-sectional view taken approximately along the length of the central portion of the device shown in Figure 20 .

[0084] Figure 21B is a top view of the device shown in Figure 21A .

[0085] Figure 21C is a cross-sectional view of the device shown in Figure 21B .

[0086] Figure 22A is a perspective view of a catheter-based system and method according to another alternative embodiment implemented on a native mitral valve, shown in a schematic cross-sectional portion of the heart.

[0087] Figure 22B is a view similar to Figure 22A but showing a subsequent step in the method.

[0088] Figure 22C is a view similar to Figure 22B but showing another subsequent step in the method.

[0089] Figure 22D is a perspective view showing the fully implanted device in a native mitral valve, resulting from the method shown in Figures 22A to 22C .

[0090] Figure 22E is a view similar to Figure 22D but showing an alternative frame structure attached to the selective occlusion device.

[0091] Figure 22F is a view similar to Figure 22E but showing another alternative frame structure.

[0092] Figure 22G is a view similar to Figure 22F but showing another alternative frame structure.

[0093] Figure 23A is a cross-sectional view of another embodiment of a heart valve repair device implanted in a native mitral valve, showing the heart in a systolic phase.

[0094] Figure 23B is a view similar to Figure 23A but showing the device and the mitral valve when the heart is in a diastolic phase.

[0095] Figure 24 is a side cross-sectional view of another alternative embodiment of a heart valve repair device implanted in a native mitral valve.

[0096] Figure 25A is a cross-sectional view of another alternative embodiment of a heart valve repair device.

[0097] Figure 25B is a cross-sectional view of another alternative embodiment of a heart valve repair device implanted in a native mitral valve.

[0098] Figure 26A is another alternative embodiment of a selective occlusion device shown in cross-section.

[0099] Figure 26B is a schematic view showing the device of Figure 26A implanted in a native mitral valve.

[0100] Figure 26C is a perspective view showing the device of Figure 26A and 26B implanted in a native mitral valve.

[0101] Figure 26D is a cross-sectional view of another alternative heart valve repair device implanted in a native mitral valve.

[0102] Figure 26E is a cross-sectional view of another alternative heart valve repair device implanted in a native mitral valve.

[0103] Figure 27A is a perspective view of another alternative selective occlusion device.

[0104] Figure 27B is a longitudinal cross-sectional view of the device shown in Figure 27A schematically showing blood flow during a systolic phase of the heart.

[0105] Figure 27C is a perspective view showing the device of Figure 27A and27B cross-sectional view of the device of

[0106] Figure 28A is a perspective view showing another alternative embodiment of another device comprising a selective occlusion device and a mitral valve clip structure.

[0107] Figure 28B is a perspective view showing Figure 28A a longitudinal cross-sectional view of the device and clip structure shown.

[0108] Figure 28C is a perspective view showing Figure 28A and 28B a cross-sectional view of the device of

[0109] Figure 29A is a cross-sectional view of a selective occlusion device and clip structure, schematically showing blood flow between endocardial wall surfaces during a systolic phase of the heart.

[0110] Figure 29B is a cross-sectional view of a device implanted into a native mitral valve, and showing the device and the mitral valve when the heart is in a systolic phase. Figure 29A

[0111] is a perspective view showing a cross-section of a mitral valve and a fully implanted selective occlusion device and clip structure. Figure 30

[0112] Figure 31 is a perspective view showing another alternative embodiment of a prosthetic heart valve and a leaflet clip structure.

[0113] Figure 32A is a side view partially sectioned to show a prosthetic heart valve and a leaflet clip structure.

[0114] Figure 32B is a cross-sectional side view of a native heart valve showing an initial portion of an implantation procedure in relation to Figure 31 and 32A a prosthetic heart valve.

[0115] Figure 32C is a view similar to Figure 32B but showing a subsequent step in the method.

[0116] Figure 32D is a view similar to Figure 32C but showing a subsequent step in the method.

[0117] Figure 32E is a view similar to Figure 32D but showing the fully implanted prosthetic heart valve clipped to the native heart valve leaflets and unfolded into an implanted state.​

[0118] Figure 33 is a perspective view of another alternative embodiment of a prosthetic heart valve and native valve leaflet clip structure.

[0119] Figure 34A is a perspective view of a prosthetic heart valve. Figure 33 is a side view of the prosthetic heart valve shown in

[0120] Figure 34B is a perspective view of a prosthetic heart valve implanted into a native heart valve. Figure 34A

[0121] is a cross-sectional view similar to Figure 35A but showing another exemplary embodiment of a heart valve repair device implanted into a mitral valve and showing a systolic phase of a cardiac cycle. Figure 29B

[0122] Figure 35B is a cross-sectional view similar to Figure 35A but showing the device and mitral valve when the cardiac cycle is in a diastolic phase. DETAILED DESCRIPTION

[0123] The detailed description herein is directed to describing non-limiting implementations or examples that relate to various inventive concepts and uses reference numerals in the drawings to facilitate understanding of these examples. As will be appreciated, common reference numerals in the drawings refer to common features and structures having the same or similar function. While various drawings will have common reference numerals referring to such common features and structures, the subsequent drawing description will not necessarily repeat discussion of these features and structures for the sake of brevity.

[0124] Reference is first made to Figure 1A ​natural heart 10 and includes a left atrium 12, a left ventricle 14, and a native mitral valve 16 that controls blood flow from the left atrium 12 to the left ventricle 14. A tricuspid valve 18 is also shown in communication with a right ventricle 19. The mitral valve 16 includes an anterior leaflet 16a, a posterior leaflet 16b, and a native annulus 16c. When the mitral valve 16 is functioning properly, it will open to allow blood to flow from the left atrium 12 into the left ventricle 14 during the diastolic portion of the cardiac cycle. When the heart 10 contracts during the systolic phase, the anterior and posterior native mitral valve leaflets 16a, 16b will fully coapt or come together to prevent any retrograde flow of blood into the left atrium 12, and the blood in the left ventricle 14 will be effectively ejected and pass completely through the aortic valve (not shown). A catheter 20 carries a collapsed selective occlusion device 22 along a guidewire 24. In this exemplary procedure, the catheter 20 is delivered through a transseptal puncture 12a. It should be understood that any other transcatheter method or other surgical method with varying degrees of invasiveness can alternatively be used. The patient can or can not be bypassed during the procedure, and the heart can or can not be beating. As Figure 1A Further shown, the native mitral valve leaflets 16a, 16b are supported by chordae 26 that are attached to papillary muscles 28. As Figure 1A shown schematically in the middle, the anterior and posterior native mitral valve leaflets 16a, 16b can not properly coapt or come together to one another when the heart is in systole during the cardiac cycle. Inadequate coaptation of the leaflets 16a, 16b can cause blood to flow backward or regurgitantly from the left ventricle 14 through the mitral valve 16 into the left atrium 12 instead of passing completely through the aortic valve (not shown).

[0125] Now referring to Figure 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 as shown in Figure 1A to the expanded state as shown in Figure 1A and Figure 1B Further shown in 1C and Figure 1B , the selective occlusion device 22 includes a collapsible and expandable frame structure 30. The frame structure 30 includes curved frame members 32 that extend generally across the native mitral valve 16 while being supported or stabilized at the native annulus 16c. The selective occlusion device 22 is collapsed for delivery as shown in 1C but expanded to Figure 1A and Figure 1B 1C ​The illustrated example form is formed in this manner. This can be accomplished in a number of ways. For example, the frame structure 30 can be constructed of a flexible polymer, such as a super-elastic metal or a shape memory metal or other material. The selective occlusion device 22 can be deployed into a pre-formed shape, for example, by use of a shape memory material. The frame structure 30 can be partially or completely covered with a fabric, such as Dacron, Teflon and / or other covering material such as used in the manufacture of artificial heart valves or other implants. More particularly, the frame structure 30 includes curved frame members 32 which, in this and / or other embodiments, extend from one commissure to the other. The frame members 32 can alternatively extend from other portions of the heart tissue located generally at the annulus region. At the opposite ends, the frame structure 30 is supported by respective first and second non-penetrating annulus connectors 34, 36. As examples of non-penetrating annulus connectors, these connectors are configured with respective upper connector elements 34a, 34b and lower connector elements 36a, 36b. These connector elements 34a, 34b and 36a, 36b respectively clamp or capture the annular tissue therebetween at each commissure. The connector elements 34a, 34b and 36a, 36b are shown as "butterfly-type" connectors which can be slid or inserted into place with the native leaflet tissue clamped therebetween or secured therebetween. It will be appreciated that other tissue capturing connectors can alternatively be used, and / or other penetrating or non-penetrating connectors. Non-penetrating connectors are advantageous in that they do not cause damage due to penetration of the connectors, and they allow for positional adjustment. The frame structure 30 also includes first and second membrane support members 40 at the opposite ends which are configured to be located in the left ventricle 14 to support a flexible membrane 44 in a slightly open condition. The flexible membrane 44 together with the frame structure 30 forms a selective occlusion device which cooperates with the native mitral valve leaflets 16a, 16b to control the flow of blood through the mitral valve 16. As described below, the flexible membrane 44 which in this embodiment serves as an artificial heart valve is moved by cooperating movement with the leaflets 16a, 16b. In other embodiments, the selective occlusion device need not have any moving parts which move with the leaflets 16a, 16b. The flexible membrane 44 is secured to the support members 38, 40 at the opposite portions of the frame structure 30 in any suitable manner, such as adhesive, mechanical fixation, suturing, fasteners, etc. As further shown, a substantial portion of the lower edge of the flexible membrane 44 is not attached to the frame structure 30. The membrane support members 38, 40 are short and curved members, and the remaining membrane portion at the lower edge of the flexible membrane 44 is not directly attached to any frame portion.As discussed further below, this allows the flexible membrane to inflate, expand, or expand outward to engage with the native leaflets 16a, 16b during systole and prevent reverse flow of blood through the mitral valve 16 in the opposite direction when the cardiac cycle is in systole.

[0126] The flexible membrane 44 can be formed from various types of thin, flexible materials. For example, the material can be natural, synthetic, or bioengineered. The material can include valve tissue or pericardial tissue from animals (e.g., cows and pigs) or other sources. Synthetic materials or combinations of materials such as ePTFE, Dacron, Teflon, or other materials can be used to construct the flexible membrane 44. The flexibility of the frame structure 30 and the flexibility of the flexible membrane 44 together provide for the operation of the selective occlusion device 22 and the manner contemplated herein, and can also help prevent failure due to fatigue caused by the repeated cyclic movement of the selective occlusion device 22 in the heart 10. It should be understood that Figure 1B The flexible membrane 44 is shown removed to clearly see the frame structure 30, and the flexible membrane 44 is shown in dashed lines in the figure, while Figure 1C The flexible membrane 44 is shown in solid lines with the cardiac cycle in the systolic phase and the flexible membrane 44 fully engaging the native leaflets 16a, 16b to reduce blood flow regurgitation through the mitral valve 16. The flexible membrane 44 can be sewn to the frame structure 30 using techniques adopted by the artificial heart valve industry for manufacturing artificial aortic valves and mitral valves. The frame can be made of one or more layers of material, such as superelastic or shape memory material, and the membrane 44 can be appropriately secured. One way can be to capture the flexible membrane 44 between the layers of the frame structure 30. To hold the membrane 44 in place, a fabric covering (not shown) attached to the metal frame can help attach the membrane 44 to the frame structure 30.

[0127] Figure 2A 、 2B and 2C is through Figures 1A to 1C A cross-section of the selective occluding device 22 and the mitral valve 16 is shown. Figure 2A Along Figure 3A The cross section of line 2A-2A shows the device 22, while Figure 2B Along Figure 3A The selective occluding device 22 is shown in cross section along line 2B-2B of FIG. 1 , and both figures show the cardiac cycle during systole. Figure 3A and 3B 3 and 4 are top views showing the contracted and expanded states, respectively, but not showing the hinge 32a which may be provided to assist in folding during delivery. Figure 2C Similar to Figure 2B , but shows the selective occluding device 22 when the cardiac cycle is in the diastolic phase. Figure 2A 、2B and 3A), it is intended that when the native mitral valve 16 is assumed to be fully closed to prevent blood flow back into the left atrium 12, pressurized blood will flow through the open end 45 of the flexible membrane and at least to a substantial extent prevent flow through the closed end 47. It will be appreciated from a review of some embodiments that a small vent can be provided in the flexible membrane. Because the flexible membrane is along Figure 2B The native mitral valve leaflets 16a, 16b will seal against or coapt with the flexible membrane 44 to prevent blood flow regurgitation as the flexible membrane bulges or expands in the direction of the arrows shown. In this manner, the mitral valve leaflets 16a, 16b, which would not otherwise seal together or coapt properly, will seal against the flexible membrane 44 during systole. To ensure coaptation, one or more portions of the flexible membrane 44 adjacent the frame structure 30 will move away from the adjacent frame structure to come into contact with the native leaflets 16a, 16b. In other words, only a portion of the lower edge of the flexible membrane 44 is attached to the frame structure 30. As shown in the cross-sectional view of FIG. 3B, the flexible membrane 44 is shown in a relaxed or resting state. The flexible membrane 44 is shown in a bulged or expanded state in FIG. 3A. Figure 2B Further shown, there can be additional membrane material near the membrane support members 38, 40 to allow for the bulged membrane condition. As shown in FIG. 3B, the flexible membrane 44 is shown in a relaxed or resting state. The flexible membrane 44 is shown in a bulged or expanded state in FIG. 3A. Figure 2C and 3B Further shown, when the cardiac cycle is in diastole and blood flow is required to occur from the left atrium 12 into the left ventricle 14 (during the filling portion of the cardiac cycle), blood will push through the flexible membrane 44 and the flexible membrane 44 will go into a deflated or contracted state as the native mitral valve leaflets 16a, 16b move apart or away from each other in the opposite direction to facilitate blood flow in the direction of the arrows. The arched membrane support members 38, 40 maintain a spacing between the lower edges or rims of the flexible membrane 44 to force blood to fill the membrane 44 in or inside through the open end 45 during systole, causing the membrane 44 to expand or bulge outwardly so that the membrane 44 fills the gap between the native mitral valve leaflets 16a, 16b. The arched or curved support members 38, 40 and / or other portions of the frame structure 30 can be formed using a central wire and a fabric covering around the wire. Other constructions are possible, such as using a soft sponge-like material, and using fabric in combination with a more structurally supportive material, such as metal and / or plastic. The filling and emptying of the flexible membrane 44 through the open end 45 can ensure that the underside of the membrane 44 is washed or rinsed with each heartbeat to prevent clot formation and to prevent any embolic material from being created.

[0128] Figure 4A and 4B respectively similar to Figure 1B and 1C but showing the selective occlusion device 22 (FIGS. 3D and 3E) isolated from the native mitral valve 16. Figure 1B and 1C .

[0129] 5A to 5DAnother embodiment of a selective occlusion device 22a is shown. As before, all like reference numerals between embodiments and figures represent like structure and function except to the extent described herein. Some reference numerals will have a suffix modification, such as a letter (e.g., "22a") or an apostrophe (e.g., 90'), indicating a modification to like structure, which will be discussed and / or apparent from a review of the figures. For greater clarity, redundant descriptions or minimization of like structure and function between various figures will not be made. This embodiment is particularly well suited to achieve the benefits of those mitral valve repairs that involve pinching or otherwise securing one native leaflet edge to the other. However, it should be understood that the clip or other anchor (collectively referred to herein as a clip structure) can be applied to only one leaflet edge, and more than one clip or anchor can be used. Typically, a mitral valve repair is performed with a clip structure 50 having first and second clip elements 50a, 50b that are movable toward each other from an open state to a closed position. The clip structure 50 is typically applied in a transcatheter procedure using a suitable catheter assembly 52. A representative and exemplary clip structure 50 is shown in these figures for pinching the edges of the native leaflets 16a, 16b together near the center of each edge. The beginning of the procedure is shown in Figure 5A , where the catheter assembly 52 is introduced through the atrial septum 12a transeptally into the left atrium 12, into the mitral valve 16, and to the left ventricle 14. A portion of the edge of each leaflet 16a, 16b is captured by the clip structure 50, which is then pinched and securely fastened together as shown in Figure 5B . At least one of the elements 50a, 50b is moved toward the other in a pinching or clamping action to change from an open state to a closed state. A wire, suture, or other tensile member or connector 54 is coupled to the clip structure 50. At or near the end of the pinching step of the procedure, a selective occlusion device 22a in the form of a frame structure 30a and a flexible membrane 44a is introduced through the catheter 52 in a manner similar to that described above with respect to the first embodiment. The selective occlusion device 22a is guided by the suture, wire, or other tensile member 54 that is attached to and extends from the clip structure 50. Figure 5D

[0130] As further shown in Figure 5C , this embodiment of the device 30a, 44a includes two portions 60, 62. This embodiment advantageously utilizes the clip structure 50 as an anchoring mechanism to help secure the device 30a, 44a in place and implanted as a selective occlusion device 22a in the native mitral valve 16. The two portions 60, 62 are employed in the manner described above in connection with the single portion embodiments of the device 30, 44. As is apparent from a review of Figure 5C and​ Figure 5D As will be appreciated in the context of the browsing, the improved frame structure 30a is employed to support the improved flexible membrane 44a. More particularly, the flexible membrane 44a includes corresponding portions 44al and 44a2. These can be formed from one or more different pieces of membrane material. In addition, third and fourth membrane support members 64, 66 are provided to support the flexible membrane portions 44al and 44a2 in a manner similar and analogous to the manner in which the support members 38, 40 in the first exemplary embodiment described above support and function. An arcuate frame member 32 is shown similar to the first embodiment, which spans the native valve 16. Vertical support members 65, 67 extend from the frame member 32 and are coupled with the membrane support members 64, 66. As another option, the frame member 32 can be omitted, and the vertical members 65, 67 or other structure can be joined together in the central region of the device 22a.

[0131] As further shown in Figure 5C The suture or wire 54 couples the clip structure 52 to the frame structure 30a, for example, by use of a crimping element or other fastener 68 generally at the hinge 32a. It will be appreciated that other fastening methods and structures can alternatively be used to secure the clip structure 50 to the frame structure 30a. The clip structure 50 and frame structure 30a can take other forms than the exemplary forms shown and described herein. The use of the clip structure 50 to secure the frame structure 30a, in addition to non-penetrating and / or other connectors, for example, generally at the native annulus 16c, provides a generally secure implant. The clip structure 50 and one or more annulus connectors will provide opposing forces that will securely fasten the frame structure 30a and flexible membrane 44a generally between the clip structure and the annulus connectors. The two separate selective occlusion or flow control portions 44al, 44a2 are separated from each other by the clip structure 50. The selective occlusion device 22a attachment to the native mitral valve 16 can be a direct connection between the flexible membrane 44a and the native leaflets 16a, 16b (see below). As another option, instead of a single arcuate frame member 32, the two side-by-side portions 60, 62 of the frame structure 30a can additionally be coupled together near the center of the selective occlusion device 22a to avoid the need for a continuous frame member 32 that spans the native mitral valve 16. Further modifications can be made while retaining the advantages of the clip structure used in conjunction with the selective occlusion device. For example, the selective occlusion device can be constructed as a frame structure, and the flexible membrane is attached around the continuous peripheral portion of the frame structure.

[0132] Figure 6A and 6BFurther embodiments of the selective occlusion devices 22b and 22c are shown. In these figures, the flexible membrane 44a is shown in dashed lines so that the respective frame structures 30b, 30c are more clearly shown. In Figure 6A In the exemplary embodiment, the central hinge is eliminated and the suture or thread 54 extends directly through the frame member 32. As with all embodiments, the device 22b, 22c and any associated components such as the frame structure 30b, 30c can be made sufficiently flexible and foldable into a collapsed state for the purpose of catheter delivery. Also, crimping elements (not shown) or any other securing means can be used to tensionally secure the thread or suture 54 against the frame structure 30b, 30c. Figure 6B Embodiments of the selective occlusion device 22c are shown which are slightly different from the embodiments of Figure 6A In these embodiments, the flexible membrane 44a is shown in dashed lines folded inwardly at the region of the clip structure 50. As Figure 6A is shown, and as an alternative, the flexible membrane 44a can be more clearly attached to the frame members as shown by the dashed lines extending upwardly against the vertical frame members 65, 67.

[0133] Figure 7A and 7B are top views showing the selective occlusion device 22c, for example Figure 6B with the separate portions 44a1 and 44a2 fixed in place and implanted within the native mitral valve 16. Figure 7A shows the selective occlusion device 22c during the diastolic phase of the cardiac cycle, while Figure 7B shows the selective occlusion device 22c during the systolic phase of the cardiac cycle. The function of a multi-segment apparatus such as with the devices 22a, 22b, 22c is similar to the function of the single segment selective occlusion device 22 discussed above in connection with the first exemplary embodiment, except that the native mitral valve itself is split by the clip structure 50 into two parts, the separate flexible membrane portions 44a1 and 44a2 acting independently to collapse or contract Figure 7A during the diastolic phase, and to bulge, deploy or expand Figure 7B outwardly during the systolic phase due to the forced introduction of blood flow as the cardiac cycle is in the systolic phase. This effect or result is similar to the effects discussed above in connection with, for example Figure 3A and 3B but with the dual effect of correcting any misalignment or lack of coaptation between the native mitral valve leaflets 16a, 16b on each side of the clip structure 50. In this way, as Figure 7AAs shown, blood is allowed to flow through the native mitral valve leaflets 16a, 16b during diastole, which spread or expand outward, and also through the two-part flexible membrane 44a, which collapses inward or away from the native mitral valve leaflets 16a, 16b. During systole, reverse or regurgitant blood flow is at least reduced, if not reduced to substantially zero (prevented), as the flexible membrane 44a expands or expands to contact or engage the native mitral valve leaflets 16a, 16b to form a fluid-tight seal.

[0134] Figure 8 Shown Figure 7B A side view of the selective occluding device 22c is shown, but the flexible membrane 44a is shown in dotted lines for clarity. The selective occluding device 22c is securely implanted in the mitral valve 16 between the annular connectors 34, 36, generally in an upper position, and the clip structure 50, in a lower position. Likewise, different connector and / or clip configurations than those shown and described may be used, and different numbers of connectors and clip structures may be used. As shown, the clip structure may be secured to each leaflet 16a, 16b simultaneously, or may be secured to individual leaflets 16a and / or 16b separately. Although the tensile member 54 is shown as having a particular length connecting between the clip structure 50 and the frame member 32, a tensile member or other type of connection of any desired length or less may be used instead. In some cases, the clip structure 50 may be directly attached to the frame structure 30.

[0135] Figure 9 A selective occlusion device 22d constructed in accordance with an exemplary embodiment is shown, employing an alternatively configured frame structure 30d coupled to a flexible membrane 44 (shown in phantom for clarity). Specifically, lower support members 70, 72, 74, 76 have different configurations for guiding the shape of flexible membrane 44. Flexible membrane 44 can be securely attached to lower support members 70, 72, 74, 76 along their entire length, along a portion of their length, or not at all along the length of the lower support members if they are properly held in place during diastole. The lower edge of flexible membrane 44 is permitted to bulge or expand outward and can be separated from lower support members 70, 72, 74, 76 along at least a substantial portion to allow this expansion or expansion to occur. Furthermore, the entire frame structure 30d and / or only the lower support members 70, 72, 74, 76 can be highly flexible to allow this expansion or expansion to occur during systole of the cardiac cycle, as previously described.

[0136] Figure 10A 、 10Band 10C show 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 can be particularly useful when applying a selective occlusion device such as according to the present disclosure to a previously implanted mitral valve clip 50. The clip 50 can be of any type or configuration. In the event that the clip 50 fails to properly repair the mitral valve 16, or in the event that the mitral valve function degrades over time despite the clip repair procedure, this embodiment helps to capture the previously implanted clip 50 and implant a selective occlusion device such as the frame structure 30a and flexible membrane 44a. In this regard, and as shown in Figure 10A and 10B the lasso or suture loop device 80 is deployed from a catheter 82 and, with the aid of a guide device 83, captures the clip 50. A suture, wire or other tensile member 54 that extends upward through the mitral valve 16 can be part of the suture loop device 80 in this embodiment and can then be used to guide and securely affix the selective occlusion device 22a to the clip 50 as generally described above, as shown in Figure 10C For the sake of clarity, the flexible membrane 44a is not shown in Figure 10C .

[0137] Figure 11A and 11B show two additional embodiments of selective occlusion devices 22e, 22f that do not show a flexible membrane that can be used to prevent blood flow regurgitation through a heart valve such as through the mitral valve 16. In these embodiments, the flexible membrane 44a( Figures 11C to 11E ) can be fixedly attached to the frame structure 90, 90' from one end to the other, such as between two non-penetrating annulus connectors, or in other embodiments, between the penetrating connector portions 92, 94, 92', 94'. Advantageously, there are two spaced apart elongated frame members 96, 98 that extend between the connectors 92, 94, 92', 94', each having an upwardly curved or hump 100, 102 that forms a concave space. As shown in Figure 11CAs shown, the flexible membrane 44a is carried on the frame structure 90, 90' and can be secured to the frame members 96, 98 along all or some of its length. As generally described above in the previously described embodiments or in the later described embodiments, this can leave a desired portion of the flexible membrane 44a unsecured at the lower edge of the frame structure 90, 90' and able to expand or billow in an outward direction during contraction. This outward expansion or billowing action will allow the flexible membrane 44 to better contact or engage the native leaflet tissue during heart contraction to prevent blood flow regurgitation. This will also allow more blood to exchange under or within the flexible membrane to prevent blood stasis and the resulting coagulation potential that can embolize and cause strokes or other complications. The raised portions 90, 90' in each of the lower septal support members 96, 98 house the clip structures 50 and generally receive the 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 the wire, suture or other tension 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 and through the mitral valve 16 in a manner similar to the frame member 32. Appropriate configurations of the frame structure 90, 90' can be used, such as any of those described previously, for housing one or more clip structures and forming a plurality of separate flexible membrane portions, for example, one on each side of the clip structure 50. Figure 11A and 11B Another way of attaching the frame structure is also shown, generally having one or more holes 106, 108, 110, 112 at the native annulus 16c to engage with a suitable securing element or anchor 114. Figure 11D Figure 11D The embodiment of FIG. 18 includes two additional securing holes 116, 118 for receiving fasteners. In some embodiments, such as that shown in FIG. 19, a penetrating anchor, such as a rivet, T-bar, wedge or other securing element can be used, although the benefits of a non-penetrating connector according to the present disclosure would be desirable, for example, for the purposes of allowing self-adjustment and reducing tissue damage. Figure 11D

[0138] Figure 12A and 12B ​​Another exemplary embodiment of a selective occlusion device 22g is shown. This 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 that have been attached together at a central location along their edges with a clip structure 50, such as the clip structure previously described. Thus, two selective occlusion elements 120 are provided for reasons similar to the two-part flexible membrane embodiment described herein. The selective occlusion elements 120 are "rigid" when used within the mitral valve 16 in that they are static and do not need to flex inwardly or outwardly to engage and disengage the native mitral valve leaflets 16a, 16b during the systolic and diastolic portions of the cardiac cycle. Rather, these disc-shaped elements 120 maintain their shape and are sized and positioned within the native mitral valve 16 such that the native mitral valve leaflets 16a, 16b engage the elements 120 during heart contraction and disengage the elements 120 during heart relaxation. This selective or periodic interaction is shown in Figure 13A and 13B and will be further described below. Figure 12A and 12B The device 22g shown in includes a frame structure 30e configured to extend generally across the native mitral valve 16, with frame members 32 and articulations 32a, as generally described in the previous embodiments, and non-penetrating annulus connectors 34, 36, as previously described. In addition, a clip structure 50 is secured to the frame structure 30e, such as by one of the previously described manners with crimping elements 68 and suture, wire or other tensile members 54. In this manner, first and second rigid selective occlusion elements 120 are disposed on opposite sides of the native mitral valve 16 and on opposite sides of the clip structure 50, respectively, to selectively include the opening formed in the native mitral valve 16 when the clip structure 50 is attached to each of the valve leaflets 16a, 16b, thereby bringing the central portions of the two valve leaflet edges into direct contact with each other or with a spacer (not shown) disposed between the movable clip elements. In this embodiment, the frame structure 30e is formed with curved or arched frame members 32 configured to extend across the native mitral valve 16 in the left atrium 12.

[0139] In Figure 12A , 12BThe selective occlusion device 22g is shown in FIGS. 13A and 13B when the cardiac cycle is in systole. The native anterior and posterior mitral valve leaflets 16a, 16b are shown pushed inward toward each other. Because the static occlusion element 120 fills any residual gap between the anterior and posterior leaflets 16a, 16b, there is no blood leakage or regurgitation. The element 120 need not have the shape depicted. Any shape that fills the space between the two leaflets 16a, 16b is sufficient if the gap is filled by the element 120. The optimal shape can be determined at least in part by studying the shape of the gap between the native mitral valve leaflets 16a, 16b in systole after the clip structure 50 is applied. The optimal shape of the element 120 for a particular patient anatomy can even be custom made for that patient through rapid manufacturing techniques. Advantages of using one or more rigid / static elements 120 include their ability to withstand repeated cyclic forces, possibly better than a design that relies on one or more mobile valve elements that can be more prone to fatigue.

[0140] Figure 12B A cross-sectional view of the mitral valve 16 is shown more particularly from commissure to commissure. At the commissures, anchor or connector 34, 36 is shown on each side above and below the leaflets 16a, 16b. At the center, there is a clip structure 50 or other attachment that is anchored to the mitral valve leaflets 16a, 16b individually or together. A tensile or other connecting member 54 extends upward from the clip attachment 50 and is attached to a frame member 32 that extends from commissure to commissure across the valve 16.

[0141] The frame structure 30e can be constructed of a metallic material such as stainless steel or nitinol. It can be preferable to use nitinol or other shape memory or super-elastic material because it can be collapsed for catheter delivery through the interior of the heart and then expanded within the interior of the heart for implantation.

[0142] The elements 120 can be constructed in a variety of ways and have a variety of shapes. They can be constructed of a metal frame, such as nitinol, that can be collapsed for catheter delivery. The metal frame can be covered with a plastic material or other artificial material such as silicone or Teflon or polyurethane. Animal or human pericardium and animal or human heart valve material or any material commonly used for construction of heart valve leaflets can be used to cover the frame structure 30e. Synthetic or bioengineered materials can also be used to cover the frame structure 30e.

[0143] The interior of the static occlusion element 120 can be hollow. Alternatively, a bladder or balloon can be located in the interior to fill the hollow interior space of the element 120. The bladder can be filled with air or any gas or liquid, such as saline, sterile water, blood, antibiotic or antiseptic fluid, polymer or a solidifiable fluid material. The use of a bladder to fill the interior of the element 120 can eliminate or reduce the need for a frame associated with the element 120.

[0144] The selective occlusion device 22g has commissure and leaflet attachments to anchor it in place. It is also possible to create this device without leaflet attachments. For example, the attachments can only be at the commissures. There is no need to have the clip structure 50 and the members connected to the frame member 32. In this case, there is no need for two occlusion elements 120. A single occlusion element 120 can be used to fill any gap between the two leaflets 16a, 16b. Of course, the shape will be different - possibly an elliptical surface that extends between the commissures. The frame for this element can be similar to the frames shown or described in connection with the first embodiment or another configuration.

[0145] Figure 12C Another exemplary embodiment or variation of a selective occlusion device 22h is shown installed inside the heart to the native mitral valve 16. There are two selective occlusion elements 120 attached to a frame structure 30f. The frame structure 30f is engaged with a clip structure 50 that attaches the anterior leaflet 16a and the posterior leaflet 16b together at the center, for example, near the A2 / P2 junction. The frame structure 30f is stabilized at the commissures and the annular region 16c of the valve 16 by connectors 34, 36.

[0146] Figure 12C The embodiment of Figure 12A and 12BThe difference here is that the support frame members 32 are not located above the elements 120, but are located below the elements 120. In other embodiments, the support frame members 32 are located above the selective occlusion device and point toward the left atrium. In this embodiment, the support frame members 32 are biased downward and toward the left ventricle, generally below the mitral valve 16. In addition, in this embodiment, the frame members 32 can be directly connected to the clip structure 50 that attaches the two leaflets 16a, 16b and the frame structure 30f together. This can allow for a procedure in which the entire device is implanted at one time. The clip structure 50, along with the selective occlusion device elements 120 coupled to the frame structure 30f can be delivered by a catheter (not shown). The clip structure 50, with or without the rest of the device exposed, can be extruded inside the heart 10 to the outside of the delivery catheter. The clip structure 50 can then be closed over the native mitral valve anterior and posterior leaflets 16a, 16b. The rest of the selective occlusion device 22h can then be released from the delivery catheter, placing the entire device in place. This can simplify the procedure to one step.

[0147] It is also important to note that in the previous embodiments, the frame structure was above the clip structure 50, while 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 arc-shaped supports or frame members, so that the support or frame structure is a complete ring or circle. This can provide further structural strength to the system.

[0148] Figure 12D is a side view schematically illustrating another exemplary embodiment of a selective occlusion device 22i that includes first and second rigid or static selective occlusion elements 120 coupled with a frame structure 30g. In this embodiment, the rigid selective occlusion elements 120 are directly coupled to the frame structure 30g, which can be a frame member 32 coupled with a clip structure 50. As in previous embodiments, the clip structure 50 can directly couple the respective edges of the anterior and posterior mitral valve leaflets 16a, 16b, or can couple these leaflet edges together against an intermediate spacer (not shown). This can serve to properly orient and position the rigid selective occlusion elements 120 on opposite sides of the clip structure 50 and within the side-by-side opening of the native mitral valve 16 created by the central clip structure 50. Optionally, additional connectors 122, 124, shown in dashed lines, can be used to help secure the rigid selective occlusion elements 120 in place at the commissures of the mitral valve 16.

[0149] Figure 13A and Figure 13B is a cross-sectional view schematically illustrating 12A to 12DSpecifically, when the cardiac cycle is in the systolic phase, the natural mitral valve leaflets 16a, 16b will cling to the rigid selective occlusive element 120 to provide a fluid seal against blood flow backflow. Figure 13B As shown, during diastole, the mitral valve leaflets 16a, 16b will spread apart and disengage from the rigid selective occlusive element 120 to allow blood to flow from the left atrium 12 into the left ventricle 14 between the rigid selective occlusive element 120 and the respective native leaflets 16a, 16b. One or more elements 120 fill any gaps between the anterior and posterior leaflets 16a, 16b. When mitral regurgitation occurs due to a failure to fully coapt the leaflets, the leaflets 16a, 16b often pull apart from each other within the plane of the valve 16 (here, left to right). However, the situation may become more complicated as mitral regurgitation becomes more severe over time, with the leaflets 16a, 16b tending to be pulled down into the ventricle 14 and apart from each other. Therefore, an upper / lower gap may also occur when one leaflet 16a or 16b is located in a higher plane than the other leaflet 16a, 16b.

[0150] An advantage of the convexly curved outer surface of element 120 is that it can be shaped to accommodate various imperfections that may occur between anterior leaflet 16a and posterior leaflet 16b. The convexly curved outer surface of element 120 can accommodate a valve space that is in the plane of valve 16 (left to right in the figure) and perpendicular to the plane of valve 16 (top to bottom in the figure).

[0151] The selective occluding device 22g is symmetrical on each side. Element 120 can also be configured so that they are asymmetrical, that is, they are not identical on opposite sides. For example, the posterior leaflet 16b can be retracted into the left ventricle 14 more than the anterior leaflet 16a. 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 16b. Element 120 can be configured to be more prominent on the side of element 120 adjacent to the posterior leaflet 16b than on the side adjacent to or facing the anterior leaflet 16a. The shape of one or more elements 120 can be adjustable, for example by an adjustable inflation level or other method to the hollow interior of element 120, to accommodate any need to fill the gap between the leaflets 16a, 16b, which would otherwise result in regurgitation.

[0152] The element 120 can also be made to order or custom-sized based on the shape of the gap. The gap can be determined by echocardiography or CT, and the appropriately sized and shaped filling element 120 can be selected based on the measurements obtained by imaging. The valve defect to be repaired may be more cylindrical in shape, and a cylindrical or pyramidal cylindrical shape may be better at preventing blood flow regurgitation than a lens or disc shape of the element 120.

[0153] The edge of the element 120 facing the incoming blood flow from the left atrium 12 has a tapered surface. This will allow the blood to flow smoothly into the left ventricle and avoid blood trauma or hemolysis and promote full and unobstructed filling of the left ventricle 14. The edge of the element 120 inside the left ventricle 14 also exhibits a taper similar to the taper of the inflow area of the element 120. When the heart starts to contract, blood will be ejected back towards the element 120 and the native leaflets 16a, 16b will start to move towards the element 120 to create a complete seal - preventing blood regurgitation when the heart contracts.

[0154] Additional options are provided and shown in Figure 13C The rigid selective occlusion element 120 can be formed in a fluid- effective manner, such as a teardrop shape or other hemodynamic shape, to prevent undesirable blood flow patterns and trauma or hemolysis as the blood flows between the element 120 and the respective mitral valve leaflets 16a and 16b.

[0155] Figure 14A 、 14B and 14C show additional embodiments of selective occlusion devices 22j, 22k, 221 utilizing rigid or static selective occlusion elements 120. These elements 120 function as discussed above in connection with 12A to 12D and Figure 13A 、 13B . In Figure 14A , the rigid or static selective occlusion element 120 is coupled to a frame structure 30h that is fixed along the top edge of the element 120. At each end of the frame structure 30h, a respective commissure connector 126, 128 is provided that includes a connecting element that operates by pinching the mitral valve tissue or other heart tissue therebetween, identical to the aforementioned butterfly element. Additional fixation is provided by the clip structure 50 and a suitable tensile element or other connector 54, such as previously described.

[0156] Figure 14B An embodiment of a selective occlusion device 22k is shown in the form of a rigid or static element 120 that again is generally disc-shaped and is fixed together by frame members 32', tensile elements or connectors 54 and connected clip structures 50.

[0157] Figure 14C An embodiment of a selective occlusion device 22i is shown in which the rigid selective occlusion element 120 is fixed together by a fabric or other structure 129 and is further fixed to a clip structure 50 by a tensile member or other connector 54 that secures the selective occlusion device 22i to the native mitral valve 16 by a pinching action as previously described.

[0158] Figures 15A to 15E Another embodiment of a selective occlusion device 22m is shown that includes a flexible membrane 44a and a frame structure 30i. The flexible membrane 44a is secured to the frame structure 30i, which is also preferably flexible for reasons such as those previously described. This embodiment is similar to the previous embodiment utilizing the flexible membrane 44a in conjunction with the mitral valve clip structure 50, but includes a central reinforced region, such as the fabric region 130, that allows the native leaflet edge tissue to be clipped directly to the reinforced fabric region 130. The clip structure 50 is Figure 15E 16c . In this alternative, the native mitral valve tissue does not directly contact adjacent native mitral valve tissue, but rather contacts and is secured against a reinforced central fabric region 130 of the flexible membrane 44a. Such a fabric or other reinforcing material 130 may be useful, for example, where the remainder of the flexible membrane is formed of a more fragile material such as a biomaterial. As generally shown in the figures, annulus connectors 132, 134 are provided and abut against an upper portion of the annulus 16c such that a clip structure 50 (not shown in this embodiment) secures the selective occluding device 22m from below to the reinforced central region 130, and the annulus connectors 132, 134 secure the selective occluding device 22m from above by abutting against or otherwise coupling to the native annulus 16c.

[0159] 16A to 16D Another exemplary embodiment of a catheter-delivered selective occluding device 22n is shown in combination with a clip structure 50. Again, the clip structure 50 is used to attach the lower central edge portion of one leaflet 16a to the lower central edge portion of the opposing leaflet 16b, generally as previously described. Again, the clamping action can 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 occluding device is coupled to a clip structure 50 that is delivered via one or more catheters 52. As Figure 16A and 16B As shown, the catheter assembly 52 is delivered transeptally into the 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 Figure 16A Capture the open state as shown Figure 16B The leaflet edge portion shown and is actuated to move one or both clip elements 50a, 50b together Figure 16C The remaining portion of the selective occluding device 22n is then extruded from the distal end of the catheter assembly 52, as shown in FIG. Figure 16C As shown. Figure 16DAs shown, as an illustrative example, it can be Figure 16D A selective occluding device 22n of the type shown or any type otherwise shown and described herein, or even other configurations contemplated herein, self-deploys into the mitral valve position. The operation of the selective occluding device 22n can be generally as described herein, and the securing 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 substantially securing the device 22n at the annulus 16c, while the clip structure 50 provides an upward force therebetween that substantially secures the selective occluding device 22n in position within the native mitral valve 16.

[0160] 17A to 17C An embodiment of the device for transcatheter delivery and implantation is shown. In this embodiment, the clip structure 50 is delivered below the mitral valve 50 and the selective occlusion device 22n is delivered to a position above the native mitral valve 16, generally as described above. The 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. Figures 17A to 17B As shown in the method. Figure 17B As shown, once in place, at least one of the clip elements is moved toward the other clip element to clamp or clip the leaflet edges together, as previously described, and also to clamp the lower central portion of the selective occluding device 22n, and particularly in this embodiment, the flexible membrane 44a, so that the leaflet edges are secured together while the selective occluding device 22n is secured and implanted in place within the native mitral valve 16. Figure 17C As shown, the selective occluding device 22n is fully extruded from the catheter assembly, whereupon it self-expands into position within the native mitral valve 16 and functions as otherwise generally discussed herein. More particularly, Figure 18A and Figure 18B Shown are the combined Figures 17A-17C The device is held in place as described during the diastolic and systolic portions of the cardiac cycle. Figure 18A During diastole, blood flow between the native mitral valve leaflets 16a, 16b and the flexible membrane 44a is permitted, while during systole, the flexible membrane 44a fills with blood in each portion and thereby expands or expands as the mitral valve leaflets 16a, 16b move toward each other and against the flexible membrane 44a to form a fluid seal, thereby preventing backflow of blood from the left ventricle 14 to the left atrium 12 of the heart 10.

[0161] Figure 19is an anatomic view from above the native mitral valve 16 with the selective occlusion device 22n superimposed to show another representation of the configuration, where the selective occlusion device 22n is curved and folded according to the natural curvature of the mitral valve 16.

[0162] Figure 20 、 21A , 21B and 21C show another embodiment of the selective occlusion device 22o and the apparatus (combining the device 22o with the clip structure 50), where the selective occlusion device 22o is generally configured as a two-segment device, but with fluid communication between the segments, as Figure 21A best shown. 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 strong frame structure 143, which can be formed in any of the ways contemplated herein, for example, to allow 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 washing during the cardiac cycle phase to reduce the chance of blood clotting.

[0163] Figures 22A-22D Another embodiment of the apparatus for transcatheter delivery and implantation of the clip structure 50 coupled with the selective occlusion device 22p is shown. The difference with this embodiment is that the clip structure 50 clips the native mitral valve leaflets 16a, 16b against a central or intermediate spacer 150, rather than directly against each other. This process is generally shown in Figures 22A-22C , where the clip structure 50 is first extruded from the transseptal guide catheter assembly 52 generally below the mitral valve leaflets 16a, 16b. As Figure 22B shown, the leaflets 16a, 16b are captured against the intermediate spacer 150. As Figure 22C shown, the leaflets 16a, 16b are securely fixed against the spacer 150 by moving at least one of the clip elements 50a, 50b toward the other. In this embodiment, each clip element 50a, 50b is moved toward the central or intermediate spacer 150 to clamp the leaflet tissue against the spacer 150. In this exemplary embodiment, the selective occlusion device 22p is already secured to the clip structure 50 as Figure 22C shown when it is extruded from the catheter assembly 52, and then the selective occlusion device 22p self-deploys into Figure 22DThe illustrated implanted state. It will be appreciated that the selective occlusion device 22p can be extruded and implanted as a separate component, and can be coupled to the clip structure 50 in a suitable manner, rather than being extruded in assembled form from the catheter 52.

[0164] Figure 22E Another embodiment similar to the embodiment illustrated Figure 22D but further illustrating respective annulus connectors 154, 156 in the form of frame members that abut against heart tissue generally at the annulus 16c in the left atrium 12, and additionally or alternatively, frame members or connectors 158, 160 (shown in dashed lines) that are coupled with the selective occlusion device 22p and that lie in the left atrium 12 to abut the annulus 16c from below. The use of both sets of annulus connectors 154, 156, 158, 160 results in clamping heart tissue therebetween for better fixation.

[0165] Figure 22F Another embodiment of the device 22q is illustrated, similar to Figure 22E but illustrating a single annulus connector 164 that is formed as part of the selective occlusion device generally around the native mitral valve 16 and that securely anchors the selective occlusion device 22q in the native mitral valve 16 against any directional rocking, but allowing for flexibility. As with all embodiments, the frame members can be formed of any desired material, such as a flexible wire-like material formed of a polymer and / or including a super-elastic or shape-memory material. This can help achieve the overall goals of embodiments for flexible use during implantation for collapsed delivery and improved flexibility of operation, as well as resistance to failure due to fatigue in this application that involves continuous circulation in the heart.

[0166] Figure 22G Another embodiment of the device 22r is illustrated. The selective occlusion device 22r can be as described in connection with any other embodiment, but is illustrated for exemplary purposes with a hollow flexible membrane 44b, while the frame structure has been modified as illustrated. The frame structure includes a generally annular frame member 170 such as described and illustrated in connection with Figure 22F but including raised portions 170a, 170b relative to other portions. The raised portions 170a, 170b are configured to lie near and above the commissures of the native mitral valve 16, and are connected with a central frame member 32 (such as with another connecting frame member 172) that extends generally across the native mitral valve 16 and is formed as part of the selective occlusion device 22r. As with all embodiments, such frame members at the annulus can be above the annulus, below the annulus, or frame members / connectors can be both above and below the annulus to clamp tissue therebetween.

[0167] Figure 23A and 23B A selective occlusion device 22s is schematically shown coupled with a central clip 50 including a spacer 150 implanted in the mitral valve 16. Figure 23A The device 22s and the mitral valve 16 are shown when the cardiac cycle is in systole, while Figure 23B The mitral valve 16 and the selective occlusion device 22s are shown when the heart is in diastole. The frame structure includes respective hooks or loops 180, 182, as shown by Figure 23A the solid lines in Figure 23B and the dashed lines in These define the openings 140, 142. The advantage of this frame construction is that the frame will not touch the commissures during repeated cardiac cycles. Like the other embodiments, this device allows blood to flow from the left atrium to the left ventricle in diastole, but prevents blood flow in systole.

[0168] Figure 24 is a cross-sectional view schematically showing the mitral valve 16 and an implanted selective occlusion device 22s coupled with a central clip structure 50, such as at the coupling 183. The selective occlusion device 22s is of the type having a hollow interior 144 with two fluidly communicating portions 184, 186 and respective first and second openings 140, 142 and a closed end 188. Fluid communication between the portions 184, 186 allows for better rinsing and washing action and reduces the chance of clotting.

[0169] Figure 25A and 25B is a schematic view of a selective occlusion device 22t, 22t' including a flexible membrane 44b, 44b', while Figure 25A and 25B The selective occlusion device 22t, 22t' is shown when the cardiac cycle is 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, while the flexible membrane 44b is not. The flexible membrane 44b of the device 22t and / or another portion, such as a frame portion, can additionally be coupled to the clip structure 50 in a manner such as shown in Figure 24 or another suitable manner.

[0170] Figure 26A , 26B and 26C schematically shows another exemplary embodiment of an apparatus including a central clip structure 50 Figure 26B and a selective occlusion device 22u. The selective occlusion device 22u, like the previous devices shown and described herein, is a hollow fluidly communicating structure having a flexible membrane 44b and allowing blood to flow into a hollow interior 144 defined by the flexible membrane 44b in systole, asFigure 26B and Figure 26C In diastole, the flexible membrane 44b collapses inwardly 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, 16b. In this embodiment, the orientation of the openings 140, 142 and the shape of the device 22u force blood to flow toward the commissure region as shown by the arrows during systole. These forces, in addition to any other fixation such as the clip structure 50, also help to hold the device 22u in place. In this manner, the device 22u can be less prone to shifting and can be more stable during implantation and use. These inlet openings 140, 142 are at an acute angle to the central clip structure 50 as shown in Figure 26B .

[0171] Figure 26D Another embodiment of a selective occlusion device 22v is shown in which a suitable baffle structure 190 is provided within the selective occlusion device 22v for directing blood flow outwardly as shown by the arrows toward the junction between the device 22v and the mitral annulus 16c. This helps to create a fixation force and stability of the device 22v in the implanted state. A single opening 192 is provided for flow during heart contraction, and the device 22v includes a closed end 194 and a hollow interior 195 so that the device 22v fills with blood during heart contraction and collapses to expel blood during heart diastole as previously shown and described. Generally as before, 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 ring shaped frame member 197. It will be understood that the shape and configuration of these structures can be modified from those shown in these example embodiments.

[0172] Figure 26E is an embodiment of a device 22w which, as with the selective occlusion device 22w, can be configured as the previous embodiments, but includes a generally annular or circular frame 200 structure which is a flat element for securing the device in place in the mitral valve 16. The frame structure 200 is shown as resting and / or secured in the left atrium 12 against heart tissue generally proximate to the mitral annulus 16c. However, it will be understood that this structure can be secured in other ways, and additional lower supports can be provided to sandwich heart tissue therebetween.

[0173] Figures 27A-27CAnother embodiment of a selective occlusion device 22x is shown that can be constructed according to the previously described embodiments, but includes at least one small vent 202 opposite the two openings 140, 142 of the flexible membrane 44b. The size of the vent 202 is not large enough to cause any significant blood backflow or leakage during systole. To the extent that the vent 202 does not allow any significant blood backflow, this end of the flexible membrane is closed, while the opposite end includes at least one, and in this embodiment, two, openings 140, 142. Otherwise, the membrane 44b operates and functions for the purposes and manner shown and described above. The one or more vents 202 can, for example, provide pressure relief to reduce forces on the device 22x during the high-pressure systolic portion of the cardiac cycle.

[0174] Figures 28A-28C Another embodiment of a device is shown that includes a central clip structure 50 and the previously described selective occlusion device 22p. In this embodiment, the clip structure 50 includes a central gripping structure 210 that may have tines or other embossed, roughened, or abrasive surfaces. This will help to grasp and hold mitral valve leaflet edge tissue between the respective clip elements 50a, 50b and the selective occlusion device 22p. The clip structure 50 is secured to the selective occlusion device 22p, for example, via the central gripping element 210. Figure 28B and 28C It is further shown that the selective blocking device 22p operates in the same manner, eg, as described above, to provide fluid communication between two generally adjacent openings 140, 142 for enhanced washing and rinsing.

[0175] Figure 29A 、 Figure 29B and Figure 30 Shown Figures 28A-28C The device is shown in operation after being implanted in the mitral valve 16. Specifically, blood enters the selective occluding 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 expands into contact with the native mitral valve leaflets 16a, 16b to form a fluid-tight seal that prevents backflow of blood during systole ( Figure 29A and 29B ). This is Figure 29B , which further illustrates the anatomy of the mitral valve 16, with the native leaflet tissue contacting the outer surface of the flexible membrane 44b during systole.

[0176] Figure 31Another embodiment is shown which illustrates a deployable prosthetic heart valve 220 which can include a generally cylindrical outer or peripheral frame structure 222 and is coupled with an internal prosthetic valve leaflet 224 which opens and closes to control blood flow therethrough. This differs from other forms of selective occlusion devices having at least one moveable valve element (e.g., a flexible membrane which operates in conjunction with a native mitral valve leaflet) in that the prosthetic heart valve 220 does not operate in conjunction with a native valve leaflet to control blood flow. Rather, the prosthetic valve leaflet 224 controls blood flow through the prosthetic heart valve 220. Coupled to the frame structure 222 is a clip structure 50 or elements which directly couple the deployable prosthetic heart valve 220 to a heart valve leaflet (e.g., the previously shown and described mitral valve leaflets 16a, 16b). Figure 32A is a partially exploded side view to show the internal stent structure 226 exposed beneath an outer covering 230 which can be native, synthetic, biological, bioengineered or any other suitable medical grade material which can be used for this type of heart device.

[0177] Figures 32B-32E A series of steps are shown for implanting the prosthetic valve 220 Figure 31 and 32A . In particular, the device can be implanted by a transcatheter procedure or a more invasive procedure such as a surgical procedure or a keyhole or other less invasive procedure. As shown in Figure 32B , the collapsed or folded device 220 is inserted between the mitral valve leaflets 16a, 16b, the clip structure 50 is used to capture the lower edges of the mitral valve leaflets 16a, 16b Figure 32C and clamp them as shown in Figure 32D . As shown in Figure 32E , the deployable prosthetic heart valve 220 is then deployed 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 valve leaflet 224 opens and closes to allow and prevent blood flow through the prosthetic heart valve 220 during diastolic and systolic phases, respectively.

[0178] Figure 33 Another embodiment is shown which is similar to the previous embodiment shown in FIG. 32 but with the addition of an upper flange element 236 which helps to secure the prosthetic heart valve 220 by stabilizing the heart valve 220 within the left atrium 12. In this regard, the flange 236 is mounted above the native mitral valve 16. The flange 236 can abut heart tissue in the lower portion of the left atrium 12. Figure 34A is a side view of the prosthetic heart valve 220 shown in Figure 33 . Figure 34Bis a diagram showing a prosthetic heart valve 220 fixed in place within a native mitral valve 16.

[0179] Figure 35A and 35B Another embodiment of a selective occlusion device 22y installed in a native mitral valve 16 is shown in cross-section. As in other embodiments, this embodiment includes a flexible membrane 44c having an open end facing the left ventricle 14 and receiving blood flow from below when the cardiac cycle is in systole ( Figure 35A ). In this portion of the cardiac cycle, the flexible membrane 44c is deployed against the native valve leaflets 16a, 16b to reduce regurgitation, as previously discussed. In diastole, the flexible membrane collapses and expels the blood therein ( Figure 35B ). Blood then travels in the opposite direction through the mitral valve 16, generally by flowing between the native valve leaflets 16a, 16b and the outer surface of the collapsed membrane 44c. This embodiment differs from other embodiments in that multiple clip structures 50 are used to secure the selective occlusion device 22y directly to the valve leaflets 16a, 16b. The valve leaflets 16a, 16b are not clipped together. It will be understood that even more clip structures 50 can be used in this embodiment, as well as in other embodiments. In this embodiment, one clip structure 50 secures one side of the flexible membrane 44c to the anterior valve leaflet 16a, while another clip structure 50 secures the flexible membrane 44c to the posterior valve leaflet 16b.

[0180] While the application has been illustrated by the description of one or more embodiments thereof, and while the embodiments have been described in considerable detail, it is not the intention that the application be limited to or by the details of the above-discussed embodiments. Additional advantages and modifications will readily occur to those skilled in the art. Therefore, the application in its broader aspects is not limited to the specific details, representative devices, and methods, and illustrative examples shown and described. Accordingly, departures can be made from such details without departure from the spirit or scope of the general inventive concept. For example, depending on the desired results and advantages, any of the features or aspects of the devices and methods described herein can be used independently of other features or aspects.

Claims

1. An apparatus for treating blood regurgitation through a native heart valve comprising a first native leaflet and a second native leaflet, the first leaflet and the second leaflet having a first leaflet free edge and a second leaflet free edge, respectively, the native heart valve being exposed to a cardiac cycle alternating between diastole and systole, the first leaflet free edge and the second leaflet free edge defining an opening therebetween that permits blood flow when the leaflet free edges are spaced apart relative to each other during the cardiac cycle, the apparatus comprising: A clip structure, which is configured to directly attach the free edge of the first leaflet and the free edge of the second leaflet together at the position of the free edge of the leaflet in a manner that changes the natural opening of the natural valve; a selective occlusion device, which can be coupled to the clip structure and is sized and configured to be implanted in the natural heart valve and disposed within the opening of the natural heart valve to selectively engage with at least one of the first natural leaflet or the second natural leaflet to reduce blood flow back through the opening of the natural heart valve when the cardiac cycle is in the systolic phase, wherein the selective occlusion device also includes an artificial heart valve, which includes a movable valve element, which is configured to selectively control blood flow through the opening of the natural heart valve, and wherein the movable valve element includes a flexible membrane, which is configured to engage the first natural leaflet and the second natural leaflet when the cardiac cycle is in the systolic phase and to disengage from the first natural leaflet and the second natural leaflet when the cardiac cycle is in the diastolic phase.

2. The device according to claim 1, wherein When the selective occluding device is disposed within the opening of the natural heart valve, the selective occluding device and at least one of the first natural leaflet or the second natural leaflet can engage with each other during the systole phase of the cardiac cycle to reduce blood reflux therebetween, and disengage from each other during the diastole phase of the cardiac cycle to allow blood to flow therethrough.

3. The device according to claim 1, wherein The selective occluding device includes one or more frame members configured to engage heart tissue proximate the annulus of a native heart valve to assist in securing the selective occluding device to the native heart valve.

4. The device according to claim 1, wherein The selective occluding device includes a flexible membrane coupled to a frame structure.

5. The apparatus according to claim 1, wherein The selective occlusion device includes a flexible membrane structure, which includes a first part and a second part, and the first part and the second part are each configured to engage with the first natural leaflet and the second natural leaflet of the natural heart valve when the cardiac cycle is in the contraction phase to reduce blood flow through the natural heart valve, and to disengage from the first natural leaflet and the second natural leaflet when the cardiac cycle is in the diastole phase to allow blood flow through the natural heart valve, wherein the first part is located on a first side of the clip structure and the second part is located on an opposite second side of the clip structure.

6. The device according to claim 5, wherein Each of the first and second parts includes a closed end and an open end, wherein, when the cardiac cycle is in the systole phase, the open end is filled with blood to allow the flexible membrane structure to expand into engagement with the first and second natural leaflets, and when the cardiac cycle is in the diastole phase, the open end is closed to allow blood to flow between the flexible membrane structure and the first and second natural leaflets.

7. The apparatus according to claim 1, wherein The clip structure includes a first clip element and a second clip element and a tensile member, wherein the first clip element and the second clip element can be moved toward each other from an open state to a closed position, and is used to attach the free edges of the leaflets together between the first clip element and the second clip element, and the tensile member is used to couple to the selective occlusion device.

8. The apparatus according to claim 1, wherein The selective occluding device includes a frame structure, and the clip structure is directly connected to the frame structure.

9. The apparatus according to claim 1, wherein The clip structure further includes two clip members, and the selective occluding device is coupled to the clip structure and secured between the clip members.

10. A device comprising: an occlusive element configured to be positionable between a first native leaflet and a second native leaflet of a native heart valve in a flow control portion of the native valve formed between the native leaflets, commissures of the native leaflets, and a clip securing edges of the native leaflets directly together; the occlusive element configured to selectively allow blood flow between the native leaflets and the occlusive element in a first direction and to inhibit blood flow between the native leaflets and the occlusive element in an opposite, second direction; and a frame structure coupled to the occluding element and coupleable to the clip in vivo after the clip has been clamped to the native valve leaflet to secure the frame structure and occluding element in the native valve in such a way that the occluding element is disposed in the flow control portion of the native valve.

11. The apparatus according to claim 10, wherein The occluding element is at least partially formed by a flexible membrane that is movable in response to blood flow adjacent thereto, the membrane being movable away from the native leaflet in response to blood flow in the first direction, and being movable toward and conforming to the native leaflet in response to blood flow in the second direction.

12. The apparatus according to claim 10, wherein The occluding element is a first occluding element, the flow control portion is a first flow control portion, and the commissure is a first commissure, and the device further comprises a second occluding element configured to be positioned between the first natural leaflet and the second natural leaflet in a second flow control portion of the natural valve formed between the natural leaflet, the second commissure of the natural leaflet, and the clip.

13. The apparatus according to claim 12, wherein The occlusive elements are hollow and in fluid communication with each other via a fluid communication structure that allows blood to flow between the occlusive elements.

14. The apparatus according to claim 13, wherein The fluid communication structure includes an opening, and the fluid communication structure is configured to allow blood to flow through each occlusive element, the fluid communication structure, and the opening.

15. The apparatus of claim 11, further comprising the clamp.

16. The apparatus according to claim 11, wherein The occlusive element is formed at least in part from a membrane to which the native leaflets can conform in response to blood flow.

17. An apparatus for treating blood regurgitation through a native heart valve, the native heart valve being exposed to a cardiac cycle alternating between a diastolic phase and a systolic phase, the native heart valve having a first native leaflet and a second native leaflet, the first and second leaflet having first and second leaflet free edges, respectively, the first and second leaflet edges defining a native opening therebetween, the natural opening permitting blood flow when the leaflet free edges are spaced apart relative to each other during the cardiac cycle, the apparatus comprising: a clip structure configured to affix a first leaflet free edge and a second leaflet free edge together in a manner that creates a clamped opening of the native valve, wherein the first leaflet free edge and the second leaflet free edge are secured proximate to each other during the cardiac cycle; A flow control device that is in vivo coupleable to the clip structure and is constructed and dimensioned to be at least partially disposed in a clamped opening and engage with at least one of the first or second native leaflets to reduce blood flow regurgitation during one of the alternating phases of the cardiac cycle, the clamped opening being located between the free edges of the attached leaflets and the commissures of the native heart valve, wherein the clip structure is permitted to be delivered to the native heart valve uncoupled from the flow control device and then coupled to the flow control device within the native heart valve.

18. The apparatus according to claim 17, wherein The clip structure includes a first clip element and a second clip element movable toward each other from an open position to a closed position to affix the leaflet free edges together.

19. The apparatus according to claim 18, wherein The clip structure includes a spacer disposed between a first clip element and a second clip element, the clip structure being configured such that each of the leaflet free edges can be captured between the spacer and the corresponding clip element.

20. The apparatus of claim 17, wherein: The flow control device is configured to be positioned in a first flow control portion of a native heart valve formed between the native leaflets, a first commissure of the native leaflets, and a clip structure affixing free edges of the leaflets together.

21. The apparatus according to claim 20, wherein The flow control device is further configured to be further disposed in a second flow control portion of the native heart valve formed between the native leaflets, the second commissures of the native leaflets, and the clip structure.

22. The apparatus of claim 17, wherein: The flow control device and at least one of the first or second natural valve leaflets can engage with each other during the systole phase of the cardiac cycle to reduce blood flow back through the clamped opening of the natural heart valve, and disengage from each other during the diastole phase of the cardiac cycle to allow blood to flow therethrough.

23. The apparatus of claim 19, wherein: The flow control device includes a frame structure, and the flow control device may be coupled to the clip structure via frame members of the frame structure.

24. The apparatus according to claim 23, wherein The frame structure includes an annulus connector configured to engage heart tissue proximate an annulus of a native heart valve to assist in securing the flow control device to the native heart valve.

25. The apparatus of claim 24, wherein: The annulus connector is non-tissue piercing and is positioned proximal to the commissures of the native heart valve.

26. The apparatus of claim 23, wherein: The flow control device includes a flexible membrane connected to the frame structure.

27. The apparatus of claim 17, wherein: The flow control device includes a flexible membrane structure having a first portion and a second portion, each of the first portion and the second portion being configured to engage with the first and second natural leaflets to reduce blood flow through the natural heart valve when the cardiac cycle is in the systolic phase, and to disengage from the first and second natural leaflets to allow blood flow through the natural heart valve when the cardiac cycle is in the diastolic phase, wherein the first portion is located on a first side of the clip structure and the second portion is located on an opposite second side of the clip structure.

28. The apparatus of claim 27, wherein Each of the first and second parts includes a closed end and an open end, wherein, when the cardiac cycle is in the systole phase, the open end is filled with blood to expand the flexible membrane structure to engage with the first and second natural leaflets, and when the cardiac cycle is in the diastole phase, the open end is emptied of blood to collapse the flexible membrane structure to allow blood to flow between the flexible membrane structure and the first and second natural leaflets.

29. An apparatus according to claim 17, wherein the flow control device includes a flexible membrane structure, the flexible membrane structure comprising a first membrane portion arranged approximately adjacent to the first natural leaflet and a second membrane portion arranged approximately adjacent to the second natural leaflet, the first membrane portion and the second membrane portion being configured to engage with at least one of the first natural leaflet or the second natural leaflet when the cardiac cycle is in the systole phase to reduce blood flow through the natural heart valve, and to disengage from at least one of the first natural leaflet or the second natural leaflet when the cardiac cycle is in the diastole phase to allow blood to flow through the natural valve.

30. The apparatus of claim 29, wherein: The clip structure includes a first clip element and a second clip element and is configured to secure the first membrane portion to the first leaflet with the first clip element and to secure the second membrane portion to the second leaflet with the second clip element.

31. The apparatus of claim 29, wherein The flexible membrane structure includes an open end and a closed end. The open end receives blood to fill the flexible membrane structure when the cardiac cycle is in the contraction phase, thereby causing the flexible membrane structure to engage with at least one of the first natural valve leaflet or the second natural valve leaflet, and the flexible membrane structure empties blood through the open end when the cardiac cycle is in the diastole phase, thereby separating the flexible membrane structure from at least one of the first natural valve leaflet or the second natural valve leaflet to allow blood to flow through the natural heart valve.

32. The apparatus of claim 31, wherein The flexible membrane structure includes a vent at the closed end through which blood can pass to provide pressure relief to reduce forces acting against the flow control device during systole.

33. The apparatus of claim 18, wherein The flow control device is coupled to the clamp structure between the first clamp element and the second clamp element.

34. The apparatus of claim 19, wherein: The flow control device is coupled to the spacer of the clip structure.

35. The apparatus of claim 17, wherein: The clip structure is configured and dimensioned to capture the leaflet free edges while coupling the flow control device to the clip structure via leaflet capture.

36. The apparatus according to claim 17 further comprises a sewing ring device configured to capture an expanded clip structure, wherein the flow control device is coupled to the expanded clip structure, the expanded clip structure having free edges of the leaflets affixed together by the sewing ring device.

37. The apparatus of claim 17, wherein: The clip structure includes a first clip and a second clip, wherein the first clip is configured to capture the free edge of the first leaflet, the second clip is configured to capture the free edge of the second leaflet, and the flow control device includes a spacer member, which is configured and sized to be disposed between the first clip and the second clip to couple the flow control device to the clip structure.

38. The apparatus according to claim 17 further comprises a delivery catheter comprising an inner cavity, the inner cavity being constructed and dimensioned to position the clip structure therein and the flow control device at the position of the natural heart valve, the flow control device having a collapsed state for delivery through the inner cavity of the delivery catheter and an expanded state when extruded from the inner cavity and secured to the natural heart valve.

39. The apparatus of claim 17, wherein: The flow control device includes one or more frame members configured to engage heart tissue proximate the annulus of a native heart valve to assist in securing the flow control device to the native valve.

40. The apparatus of claim 39, wherein The flow control device may be coupled to the clamp structure.

41. An apparatus for treating blood regurgitation through a native heart valve comprising a first native leaflet and a second native leaflet, the apparatus comprising: A selective occlusive device sized and configured to be implanted in the native heart valve and selectively operate with at least one of the first or second native leaflets to allow blood to flow through the native heart valve between the selective occlusive device and at least one of the first or second native leaflets during the diastole phase of the cardiac cycle and to reduce backflow of blood through the native heart valve during the systole phase of the cardiac cycle, a clip structure that is allowed to be delivered to the native heart valve uncoupled from the selective occlusive device and then coupled to the selective occlusive device within the native heart valve, the clip structure being configured to attach to edges of the first and second native leaflets to secure the selective occlusive device to the native heart valve, wherein the selective occlusive device further includes an occlusive element located between the clip structure and the commissures of the native heart valve.

42. The apparatus of claim 41, wherein The clip structure includes a clip comprised of a pair of clip elements, at least one of which is movable between an open position and a closed position, and wherein the clip elements capture native leaflet tissue between the clip elements in the closed position.

43. The apparatus of claim 41, wherein The clip structure also includes: a first clip and a second clip, each of which includes a pair of clip elements, at least one of the clip elements in each pair is movable between an open position and a closed position relative to the other clip element in each pair of clip elements, and wherein the first clip is configured to attach the first natural leaflet to the selective occlusion device, and the second clip is configured to attach the second natural leaflet to the selective occlusion device.

44. The apparatus of claim 41 , further comprising: a frame structure coupled to the clip structure, and a non-penetrating annulus connector coupled to the frame structure, the annulus connector being configured to engage with heart tissue without penetrating the tissue, wherein the frame structure is configured to extend across the native heart valve approximately between the commissures, and the selective occlusion device is secured in place approximately between the clip structure and the annulus connector.

45. The apparatus of claim 44, wherein The annulus connector provides a first force to cardiac tissue approximately at the annulus, and the clip structure provides a second, opposing force at a lower edge of at least one of the first or second natural leaflets to retain the selective occlusion device between the annulus connector and the clip structure.

46. ​​The apparatus of claim 41, wherein The occluding element is a rigid element that is sized and configured to be implanted in the native heart valve such that when the cardiac cycle is in the systolic phase, at least one of the first or second natural leaflets engages with the rigid element to reduce blood flow through the native heart valve, and when the cardiac cycle is in the diastolic phase, at least one of the first or second natural leaflets disengages from the rigid element to allow blood flow through the native heart valve.

47. The apparatus of claim 41 , further comprising: at least one catheter carrying the selective occluding device and the clip structure, wherein the at least one catheter is configured to deliver the selective occluding device and the clip structure to the site of the native heart valve, and the selective occluding device has a collapsed state for delivery through the at least one catheter and an expanded state for implantation in the native heart valve.

48. The apparatus of claim 47, further comprising: A frame structure having a collapsed state for delivery via at least one catheter and an expanded state for implantation at the native heart valve, and an annulus connector coupled to the frame structure, the annulus connector being configured to engage with cardiac tissue approximately at the annulus of the native heart valve, wherein the frame structure is configured to extend across the native heart valve and the selective occlusion device is secured in place approximately between the clip structure and the annulus connector.

49. The apparatus of claim 48, further comprising: A clip structure capture device is extendable from the at least one catheter and is configured to capture the clip structure and connect the clip structure to the frame structure during implantation of the selective occluding device.

50. The apparatus of claim 41, wherein The occluding element is a first occluding element, the commissure is a first commissure of the natural heart valve, and the selective occluding device further comprises a second occluding element, the second occluding element being located between the clip structure and the second commissure of the natural heart valve, the first occluding element and the second occluding element being sized and constructed to be implanted in the natural heart valve such that when the cardiac cycle is in the systole phase, at least one of the first natural leaflet or the second natural leaflet engages the first occluding element and the second occluding element to reduce blood flow through the natural heart valve, and when the cardiac cycle is in the diastole phase, the at least one of the first natural leaflet or the second natural leaflet disengages from the first occluding element and the second occluding element to allow blood flow through the natural heart valve.

51. The apparatus of claim 41, wherein The occluding element is a first occluding element, the commissure is a first commissure of the natural heart valve, and the selective occluding device further comprises a second occluding element, the second occluding element being located between the clip structure and the second commissure of the natural heart valve, the first occluding element and the second occluding element being each configured with a flexible membrane structure, the flexible membrane structure engaging with the first and second natural leaflets of the natural heart valve when the cardiac cycle is in the contraction phase to reduce blood flow through the natural heart valve, and disengaging from the first and second natural leaflets when the cardiac cycle is in the diastole phase to allow blood flow through the natural heart valve, wherein the first occluding element is located on a first side of the clip structure, and the second occluding element is located on an opposite second side of the clip structure.

52. The apparatus of claim 51, wherein Each of the first and second occlusive elements includes a closed end and an open end, wherein when the cardiac cycle is in the systole phase, the open end receives blood flow to cause the membrane to expand into engagement with the first and second natural leaflets, and when the cardiac cycle is in the diastole phase, the open end closes to allow blood to flow between the membrane and the first and second natural leaflets.

53. An apparatus for treating blood regurgitation through a native heart valve comprising a first native leaflet and a second native leaflet, the apparatus comprising: A selective occlusion device sized and configured to be implanted in the native heart valve and selectively operate with at least one of the first or second native leaflets to allow blood flow through the native heart valve during the diastole phase of the cardiac cycle and to reduce backflow of blood through the native heart valve during the systole phase of the cardiac cycle, a frame structure coupled to the selective occlusion device, and a clip structure that is allowed to be delivered to the native heart valve uncoupled from the selective occlusion device and then engage the selective occlusion device within the native heart valve. The selective occlusion device is coupled to the natural heart valve, the clip structure being configured to be attached to the edges of the first and second natural leaflets to secure the selective occlusion device to the natural heart valve, wherein the clip structure includes a clip consisting of a pair of clip elements, at least one of the clip elements being movable between an open position and a closed position, and the clip elements capturing natural leaflet tissue therebetween in the closed position, wherein the selective occlusion device includes an occlusion element configured to be located between the clip structure and the commissure of the natural heart valve.

54. The apparatus of claim 53, further comprising: A non-penetrating annulus connector is coupled to the frame structure, the annulus connector being configured to engage with heart tissue without penetrating the tissue, wherein the frame structure is configured to extend across the native heart valve and the selective occlusion device is secured in position substantially between the frame structure and the annulus connector.

55. The apparatus of claim 53, further comprising a plurality of clip structures configured to affix the edges of the first and second natural leaflets to the selective occlusion device.

56. The apparatus of claim 53, further comprising: A spacer is mounted between a pair of clip elements, wherein the native leaflet tissue is engaged between the clip elements and the spacer.

57. The apparatus of claim 54, wherein The annulus connector provides a first force to cardiac tissue approximately at the annulus, and the clip structure provides a second, opposing force at a lower edge of at least one of the first or second natural leaflets to retain the selective occlusion device between the annulus connector and the clip structure.

58. The apparatus of claim 53, wherein The selective occlusion device also includes a rigid element that is sized and configured to be implanted in the native heart valve such that when the cardiac cycle is in the systolic phase, at least one of the first or second natural leaflets engages with the rigid element to reduce blood flow through the native heart valve, and when the cardiac cycle is in the diastolic phase, at least one of the first or second natural leaflets disengages from the rigid element to allow blood flow through the native heart valve.

59. The apparatus of claim 54, further comprising: At least one catheter carrying the selective occlusion device and the annulus connector, wherein the at least one catheter is configured to deliver the selective occlusion device and the annulus connector to the site of the native heart valve, and the selective occlusion device has a collapsed state for delivery via the at least one catheter and an expanded state for implantation in the native heart valve.

60. The apparatus of claim 53, wherein The occluding element is a first occluding element, the commissure is a first commissure of the natural heart valve, and the selective occluding device further comprises a second occluding element, the second occluding element being located between the clip structure and the second commissure of the natural heart valve, the first occluding element and the second occluding element being each configured with a flexible membrane structure, the flexible membrane structure engaging with the first and second natural leaflets of the natural heart valve when the cardiac cycle is in the contraction phase to reduce blood flow through the natural heart valve, and disengaging from the first and second natural leaflets when the cardiac cycle is in the diastole phase to allow blood flow through the natural heart valve, wherein the first occluding element is located on a first side of the clip structure, and the second occluding element is located on an opposite second side of the clip structure.

61. The apparatus of claim 60, wherein Each of the first and second occlusive elements includes a closed end and an open end, wherein when the cardiac cycle is in the systole phase, the open end receives blood flow to cause the membrane to expand into engagement with the first and second natural leaflets, and when the cardiac cycle is in the diastole phase, the open end closes to allow blood to flow between the membrane and the first and second natural leaflets.

62. An apparatus for treating blood regurgitation through a native heart valve comprising a first native leaflet and a second native leaflet, the apparatus comprising: A selective occlusion device sized and configured to be implanted in the native heart valve and selectively operate with at least one of the first or second native leaflets to allow blood to flow through the native heart valve during the diastole phase of the cardiac cycle and to reduce backflow of blood through the native heart valve during the systole phase of the cardiac cycle, and a clip structure capture device extendable from at least one catheter and configured to capture the clip structure securing the first and second native leaflets to each other to allow the clip structure to be delivered to the native heart valve uncoupled from the selective occlusion device and then coupled to the selective occlusion device within the native heart valve, the selective occlusion device further comprising an occlusion element positioned between the clip structure and the commissure of the native heart valve when the clip structure is coupled to the selective occlusion device.

63. The apparatus of claim 62, wherein The clip structure capture device also includes a snare or sewing loop device.

64. The apparatus of claim 62, further comprising: At least one catheter carrying the selective occluding device and the clip structure capture device, wherein the at least one catheter is configured to deliver the selective occluding device and the clip structure capture device to the site of the natural heart valve, and the selective occluding device has a collapsed state for delivery through the at least one catheter and an expanded state for implantation in the natural heart valve.

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