Patent Description:
Heart valve incompetence, in various forms and affecting various of the heart valves (e.g., the aortic valve, tricuspid valve, pulmonary valve and mitral valve), has led to a growing area of research and development designed to improve heart valve functionality. Although any one or more of these native heart valves may be compromised due, for example, to congenital disorders or, more often, disease conditions, the mitral valve has received particular attention. Regurgitation of blood flow through a heart valve, such as a mitral valve, involves the backward flow of blood through the valve when the valve is supposed to be fully closed (i.e., full coaptation of the native leaflets). A diseased or otherwise compromised mitral valve will often allow regurgitated blood flow from the left ventricle into the left atrium during cardiac systole. This causes the amount of blood ejected from the left ventricle during cardiac systole to be reduced, leading to less than optimal "ejection fraction" for the patient. Thus, the patient may experience a lower quality of life due to this inefficiency of their heart or, worse, a life-threatening condition.

Surgical techniques as well as transvascular or catheter-based techniques for treatment of mitral valve incompetence have been developed and, for example, include mitral annuloplasty, attachment of the native anterior mitral leaflet to the native posterior mitral leaflet, chordal replacement and even complete mitral valve replacement.

In many cases, mitral valve regurgitation is related not to congenital defects in the mitral valve leaflets but to changes in the coaptation of the leaflets over time due to heart disease. In these situations, the native mitral leaflets are often relatively normal, but they nevertheless fail to prevent regurgitation of blood from the left ventricle into the left atrium during cardiac systole. Instead of the native anterior and posterior leaflets properly mating or coapting together completely during cardiac contraction or systole, one or more gaps between the native leaflets cause mitral regurgitation.

A current, commonly used technique for reducing mitral valve regurgitation involves the attachment of the native mitral valve anterior leaflet to the native mitral valve posterior leaflet using a clip structure. The clip structure is used to securely affix centrally located points on the margins of the anterior and posterior leaflets together. This causes the mitral valve to essentially be divided into two flow control portions, with one on each side of the clip structure. The clip structure may take a simple form that directly clips the anterior leaflet and the posterior leaflet into contact with each other at the central locations on each leaflet margin, or it may include a spacer against which each leaflet is clipped, such as by a wider, paddle type structure. In either case, the clip structure keeps the mitral leaflets securely together in a manner that withstands the repetitive forces of the heart cycle.

When the native anterior and posterior mitral leaflets are affixed together at approximately the center of the valve (i.e., A2 and P2 locations of the native leaflets), there can still be a persistent leak on one or both sides of the clip leading to regurgitation.

It would be useful to further address these and other problems or challenges associated with heart valve incompetence. <CIT> concerns an apparatus for treating a deficient mitral valve including an expandable spacer configured for placement between the native leaflets of the mitral valve, the spacer anchorable to a wall of the ventricle.

According to the invention as set out in claim <NUM>, apparatus for treating blood flow regurgitation through a native heart valve including first and second native leaflets is provided and generally includes 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 selectively operates with at least one of the first or second native leaflets to allow blood flow through the native heart valve when the heart cycle is in the diastole and reduce blood flow regurgitation through the native heart found when the heart cycle is in systole. The clip structure is coupled with the selective occlusion device. The clip structure is configured to be affixed to a margin of at least one of the first or second native leaflets to secure the selective occlusion device to the native heart valve.

Various other additional and/or optional features are provided with some examples summarized below. The clip structure may include a clip comprised of a pair of clip elements. At least one of the clip elements is movable between open and closed positions. The clip elements capture native leaflet tissue therebetween in the closed position. The clip structure may optionally or additionally comprise first and second clips each including a pair of clip elements. At least one of the clip elements of each pair is movable between open and closed positions relative to the other clip element of each pair. The first clip may be configured to attach the first native leaflet to the selective occlusion device and the second clip may be configured to attach the second native leaflet to the selective occlusion device. As another option, a single clip structure may be used at approximately a central location between opposing native leaflets, such as the anterior and posterior native leaflets of the native mitral valve, and this single clip structure may simultaneously capture leaflet tissue of the anterior and posterior leaflets. It will be appreciated that the aspects and features discussed herein are applicable to any of the native heart valves, including the pulmonary valve, the tricuspid valve, the aortic valve and the mitral valve. For an understanding of general principles, illustrative embodiments are described in connection with treating the native mitral valve.

According to the invention, the selective occlusion device comprises a prosthetic heart valve including a movable valve element configured to selectively control blood flow through the native heart valve. The movable valve element further comprises a flexible membrane configured to engage at least one of the first or second native leaflets of the native heart valve when the heart cycle is in systole and disengage the at least one of the first or second native leaflets when the heart cycle is in diastole. The flexible membrane may further include a closed end and an open and. The open end receives blood flow when the heart cycle is in systole to expand the membrane into engagement with the first and second native leaflets in systole, and the open end closes when the heart cycle is in diastole to allow blood flow between the membrane and the first and second native leaflets.

As another optional and/or additional feature, some embodiments may include a frame structure coupled with the clip structure. An annulus connector and, preferably, a non-penetrating annulus connector is coupled with the frame structure. The annulus connector is configured to engage the heart tissue without penetrating through the tissue. The frame structure is configured to extend across the native heart valve generally between the commissures, in some embodiments, and the selective occlusion device is secured in place generally between the clip structure and the annulus connector. The frame structure may extend across the native heart valve at locations in addition to or different from the commissure locations. Also in some embodiments, the annulus connector or connectors provide a first force on heart tissue generally at the annulus and the clip structure provides an opposing, second force (relative to the first force) at a lower margin of at least one of the first or second native leaflets to hold the selective occlusion device generally between the annulus connector(s) and the clip structure.

In some embodiments, the clip structure includes a pair of clip elements movable between open and closed positions, and the clip elements capture native leaflet tissue therebetween in the closed position, and may either allow the leaflet tissue to directly engage in an abutting manner (e.g., anterior leaflet to posterior leaflet) or indirectly against a spacer located between leaflet tissue. Particularly, a spacer may be mounted 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 may further comprise one or more rigid selective occlusion elements sized and configured to be implanted in the native heart valve such that at least one of the first or second native leaflets engages the rigid element when the heart cycle is in systole to reduce regurgitation of blood flow through the native heart valve, and the at least one of the first or second native leaflets disengages the rigid element when the heart cycle is in diastole to allow blood flow through the native heart valve. In some embodiments the selective occlusion device further comprises first and second selective occlusion element sized and configured to be implanted in the native heart valve such that at least one of the first or second native leaflets engages the first and second selective occlusion elements when the heart cycle is in systole to reduce blood flow through the native heart valve, and the at least one of the first or second native leaflets disengages the first and second selective occlusion elements when the heart cycle is in diastole to allow blood flow through the native heart valve. The selective occlusion element or elements may be rigid. The term "rigid" is not intended to mean that the selective occlusion device has no flexibility, but only that the selective occlusion device in these embodiments need not rely on a flexible membrane actively moving to engage and/or disengage one or more of the native leaflets. In other words, the selective occlusion element or elements may be static in operation.

In some embodiments, the apparatus further comprises at least one catheter carrying the selective occlusion device and/or the clip structure and/or the frame structure. It will be appreciated that a catheter or transvascular delivery system may include the use of multiple catheters. One or more catheters is/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 may have a collapsed condition designed for delivery in a transvascular manner and an expanded condition for implantation in the native heart valve. Likewise, the frame structure may have a collapsed condition for delivery through at least one catheter and an expanded condition for implantation in the native heart valve.

In another illustrative embodiment, apparatus for treating blood flow regurgitation through a native heart valve including first and second native leaflets is provided and generally includes a selective occlusion device coupled with a frame structure. More particularly, the selective occlusion device may be configured in any of the manners contemplated herein, such as any of the manners summarized 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 through the tissue. The frame structure is configured to extend across the native heart valve generally supported by the annulus and the selective occlusion device is secured in place generally between the frame structure and the annulus connector. In some embodiments, for example, the annulus connector may be an annular element configured to essentially sit on top of the mitral annulus, in the left atrium of the native heart. In other embodiments, multiple annulus connectors may be utilized. For example, first and second annulus connectors may be used to sit or locate at the annulus level abutting the respective mitral commissures or at other generally opposite locations along the native valve annulus. It will be appreciated that any of the features discussed and/or contemplated hereby may be combined together to achieve advantageous results.

In other illustrative aspects, methods for treating blood flow regurgitation through a native heart valve are provided. In some illustrative methods, the method comprises delivering a selective occlusion device into the native heart valve between the first and second native leaflets. A clip structure is delivered in proximity to a margin of at least one of the first or second native leaflets. The clip structure is a fixed to the margin of the at least one of the first or second native leaflets. The selective occlusion device is secured to the clip structure, and 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 the heart cycle is in diastole and to reduce blood flow regurgitation through the native heart valve when the heart cycle is in systole.

As with other aspects and illustrative embodiments, various additional and/or optional features of the methods may be employed. The clip structure may further include a clip comprised of a pair of clip elements and affixing the clip structure may further include moving at least one of the clip elements between open and closed positions, and capturing native leaflet tissue between the clip elements in the closed position. The clip structure, in some embodiments, may further comprise first and second clips each including a pair of clip elements, with at least one of the clip elements of each pair movable between open and closed positions relative to the other clip element of each pair. Affixing the clip structure may further comprise attaching the first clip to the first native leaflet and to the selective occlusion device, and attaching the second clip to the second native leaflet and to the selective occlusion device. The selective occlusion device may further comprise a prosthetic heart valve including a movable valve element, and using the selective occlusion device may further comprise selectively controlling blood flow through the native heart valve by moving the movable valve element between open and closed positions. In some embodiments, the movable valve element may further comprise a flexible membrane, and using the selective occlusion device may further comprise engaging at least one of the first or second native leaflets of the native heart valve with the flexible membrane when the heart cycle is in systole to reduce regurgitation of blood flow through the native heart valve, and disengaging the at least one of the first or second native leaflets from the flexible membrane when the heart cycle is in diastole to allow blood flow through the native heart valve. In some embodiments the method comprises engaging the first and second native leaflets of the native heart valve with the flexible membrane when the heart is in systole to reduce regurgitation of blood flow through the native heart valve, and disengaging the first and second native leaflets from the flexible membrane when the heart cycle is in diastole to allow blood flow through the native heart valve. The flexible membrane may include a closed end and an open end. Engaging the first and second native leaflets may further include receiving blood flow through the open end when the heart cycle is in systole to expand the membrane into engagement with the first and second native leaflets, and disengaging the first and second native leaflets may include closing the open end when the heart cycle is in diastole to allow blood flow between the membrane and the first and second native leaflets.

The method may further comprise coupling a frame structure with the clip structure. A non- penetrating annulus connector may be engaged with heart tissue proximate the native heart valve annulus, and the frame structure may be secured across the native heart valve and to the non-penetrating annulus connector such that the selective occlusion device is secured in place generally between the clip structure and the non-penetrating annulus connector. In some embodiments, a first force may be provided on heart tissue with the annulus connector or connectors, and a second force opposing the first force may be provided by the clip structure at a lower margin of at least one of the first or second native leaflets to hold the selective occlusion device between the annulus connector or connectors and the clip structure. For example, these forces may be pushing and pulling type forces. Also in some embodiments, the method may utilize a pair of clip elements as the clip structure, with at least one of the clip elements movable between open and closed positions, and affixing the clip structure may further comprise capturing the native leaflet tissue between the clip elements and a spacer when the at least one clip element is moved to the closed position. In other embodiments, the clip structure causes abutting leaflet tissue to directly contact when the clip is closed. Also in some embodiments, the selective occlusion device may further comprise a rigid element, as generally discussed herein, and engaging the rigid element of the selective occlusion device with at least one of the first or second native leaflets when the heart cycle is in systole reduces blood flow regurgitation through the native heart valve, and disengaging the rigid element from the at least one of the first or second eight of leaflets when the heart cycle is in diastole allows blood flow through the native heart valve between the rigid element and the at least one of the first or second native leaflets.

In various illustrative embodiments of the methods, the selective occlusion device and/or the clip structure and/or the frame structure, as well as other components used in the methods, may be delivered and implanted in a transvascular manner. For example, the selective occlusion device may be directed with or without the clip structure through at least one catheter with the selective occlusion device in a collapsed condition. The selective occlusion device is extruded from the distal end of the at least one catheter, and the device is expanded in the native heart valve. The method may further comprise transvascularly delivering a frame structure to the native heart valve, transvascularly delivering the clip structure to the native heart valve, and engaging a non-penetrating annulus connector with heart tissue proximate the native heart valve annulus. The frame structure may be secured across the native heart valve and to the non-penetrating annulus connector such that the selective occlusion device is secured in place generally between the clip structure and the non-penetrating annulus connector. In another optional and/or additional aspect, the method may further comprise transvascularly delivering a clip structure capturing device, capturing the clip structure with the capturing device, and connecting the clip structure to the frame structure during implantation of the selective occlusion device in the native heart valve.

In another illustrative method for treating blood flow regurgitation through a native heart valve including at least first and second native leaflets, the method comprises delivering a selective occlusion device into the native heart valve between the first and second native leaflets. A frame structure is delivered in proximity to the native heart valve. The frame structure is affixed to the annulus of the native heart valve with 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 the heart cycle is in diastole and to reduce blood flow regurgitation through the native heart valve when the heart cycle is in systole. Any of the additional and/or optional features summarized, discussed or otherwise contemplated herein may be used in carrying out this general method.

In another illustrative embodiment, an apparatus for treating blood flow regurgitation through a native heart valve including first and second native leaflets is provided and generally includes a prosthetic heart valve, and a clip structure. More specifically, the prosthetic heart valve includes a peripheral, generally cylindrical frame movable between collapsed and expanded conditions, and a plurality of prosthetic leaflets secured within the peripheral, generally cylindrical frame. The prosthetic leaflets are movable between open and closed conditions to respectively control blood flow through the prosthetic heart valve. The frame is implanted by expansion against 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 be affixed to a margin of at least one of the first or second native leaflets to secure the prosthetic heart valve to the native heart valve. As optional and/or additional aspects, the clip structure may further comprise first and second clips each including a pair of clip elements, with at least one of the clip elements of each pair movable between open and closed positions relative to the other clip element of each pair. The first clip is configured to attach the first native leaflet to the prosthetic heart valve in the second clip is configured to attach the second native leaflet to the prosthetic heart valve. The prosthetic heart valve may take any desired form, with one example being an expandable stent structure comprising the frame.

As another illustrative method, the prosthetic heart valve may be transvascularly delivered in a collapsed condition to a space within the native heart valve. The prosthetic heart valve is clipped to the first and second native leaflets by capturing margins of the first and second native leaflets between respective clip elements. The prosthetic heart valve is expanded against the first and second native leaflets, and the flow of blood is controlled through the native heart valve by movement of the prosthetic leaflets of the prosthetic heart valve. As optional and/or additional features of the method, clipping the prosthetic heart valve may further comprise capturing the anterior leaflet of the native mitral valve with a first clip, and capturing the posterior native leaflet of the native mitral valve with a second clip.

In another illustrative embodiment, apparatus for treating blood flow regurgitation through a native heart valve including first and second native leaflets generally includes a selective occlusion device and a clip structure capturing device. The selective occlusion device is sized and configured to be implanted in the native heart valve and selectively operates with at least one of the first or second native leaflets to allow blood flow through the native heart valve when the heart cycle is in diastole and reduce blood flow regurgitation through the native heart valve when the heart cycle is in systole. The clip structure capturing device is extendable from at least one catheter and configured to capture a clip structure or other anchor securing 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 capturing device may further comprise a snare or suture loop device. At least one catheter may carry the selective occlusion device and the clip structure capturing device. In this case, the at least one catheter is configured to deliver the selective occlusion device and the clip structure capturing device to the site of the native heart valve, and the selective occlusion device has a collapsed condition for delivery through the at least one catheter and an expanded condition for implantation in the native heart valve. It will be appreciated that the different components may be carried and delivered in different catheters. Any of the other features or aspects of this disclosure may be additionally or optionally used in this embodiment.

In another illustrative method, blood flow regurgitation through a native heart valve including first and second native leaflets may be treated by capturing a clip structure or other anchor secured to a margin of at least one of the first or second native leaflets. A selective occlusion device is delivered into the native heart valve between the first and second native leaflets while the clip structure or other anchor is captured, and the selective occlusion device is 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 the heart cycle is in diastole and reduce blood flow regurgitation through the native heart valve when the heart cycle is in systole. Capturing the clip structure may further comprise ensnaring the clip structure with a tensile member. Securing the selective occlusion device may further comprise attaching a tensile member between the clip structure and the selective occlusion device. Securing the selective occlusion device may further comprise attaching the clip structure to a frame member of the selective occlusion device. Again, this method may additionally or optionally include other features or aspects contemplated by the methods disclosed or contemplated herein.

In another illustrative embodiment, a selective occlusion device is provided for assisting with control of blood flow through a native heart valve including first and second native leaflets. The selective occlusion device is sized and configured to be implanted in the native heart valve adjacent a clip structure that separates the native heart valve into at least two internal valve sections between the first and second native leaflets and two external valve sections behind the first and second native leaflets. Generally, the selective occlusion device may be implanted on at least one side of, for example, a clip structure that secures two native leaflets of a heart valve together and thereby essentially bisects the native valve into two internal sections through which blood will flow through the valve, and two exterior sections outside of the leaflets (i.e., behind the leaflets). The selective occlusion device may control blood flow in any desired manner, including as examples, one or more of the manners contemplated herein.

In another illustrative 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 separating the native heart valve into at least two internal valve sections between the first and second native leaflets and two external valve sections behind the first and second native leaflets. The selective occlusion device is used to assist with controlling blood flow through the native heart valve during the heart cycle. Again, the selective occlusion device may control blood flow in any desired manner, including as examples, one or more of the manners contemplated herein.

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

The detailed description herein serves to describe non-limiting embodiments or examples involving various concepts and uses reference numbers for ease of understanding these examples. Common reference numbers between the figures refer to common features and structure having the same or similar functions, as will be understood. While various figures will have common reference numbers referring to such common features and structure, for purposes of conciseness, later figure descriptions will not necessarily repeat a discussion of these features and structure.

Referring first to <FIG>, a native heart <NUM> is shown and includes a left atrium <NUM>, a left ventricle <NUM>, and a native mitral valve <NUM>, which controls blood flow from the left atrium <NUM> to the left ventricle <NUM>. The tricuspid valve <NUM> is also shown in communication with the right ventricle <NUM>. The mitral valve <NUM> includes an anterior leaflet 16a, a posterior leaflet 16b and a native valve annulus 16c. When the mitral valve <NUM> is functioning properly, it will open to allow blood flow from the left atrium <NUM> into the left ventricle <NUM> during the diastole portion of the heart cycle. When the heart <NUM> contracts during systole, the anterior and posterior native mitral leaflets 16a, 16b will fully coapt or engage with one another to stop any blood flow in the reverse direction into the left atrium <NUM> and blood in the left ventricle <NUM> will be ejected efficiently and fully through the aortic valve (not shown). A catheter <NUM> carries a collapsed selective occlusion device <NUM> along a guide wire <NUM>. In this illustrative procedure, the catheter <NUM> is delivered transeptally across the inter-atrial septum 12a. It will be appreciated that any other transcatheter approach, or other surgical approaches of various levels of invasiveness, may be used instead. The patient may or may not be on bypass and the heart may or may not be beating during the procedure. As further shown in <FIG>, the native mitral leaflets 16a, 16b are supported by chordae tendineae <NUM> attached to papillary muscles <NUM>. As schematically illustrated in <FIG>, the anterior and posterior native mitral leaflets 16a, 16b may not properly coapt or engage with one another when the heart cycle is in systole. Insufficient coaptation of the leaflets 16a, 16b leads to blood flow out of the left ventricle <NUM> in a backward direction, or in regurgitation, through the mitral valve <NUM> into the left atrium <NUM> instead of fully through the aortic valve (not shown).

Now referring to <FIG> in conjunction with <FIG> and <FIG>, the selective occlusion device <NUM> has been fully extruded or extended from the distal end 20a of the catheter <NUM>, and transformed from the collapsed position or condition shown in <FIG> within the catheter <NUM>, to the expanded condition shown in <FIG> and <FIG>. As further shown in <FIG> and <FIG>, the selective occlusion device <NUM> comprises a collapsible and expandable frame structure <NUM>. The frame structure <NUM> is comprised of a curved frame number <NUM> generally extending across the native mitral valve <NUM> while being supported or stabilized at the native annulus 16c. The selective occlusion device <NUM> is formed in a manner allowing it to be collapsed for delivery as shown in <FIG>, but expanded to the exemplary form shown in <FIG> and <FIG>. This may be accomplished in many ways. For example, the frame structure <NUM> may be comprised of flexible polymers, metals such as super-elastic or shape memory metals or other materials. The selective occlusion device <NUM> may, for example, expand into a preformed shape through the use of shape memory materials. The frame structure <NUM> may be covered partially or completely by fabrics such as the Dacron, Teflon and/or other covering materials such as used in the manufacture of prosthetic cardiac valves or other implants. More specifically, the frame structure <NUM> includes a curved frame member <NUM> which, in this embodiment, and/or other embodiments, extends from one commissure to the other. The frame member <NUM> may instead extend from other portions of the heart tissue generally located at the annulus region. At opposite ends, the frame structure <NUM> is supported by respective first and second non-penetrating annulus connectors <NUM>, <NUM>. As an example of a non-penetrating annulus connector, these connectors are configured with respective upper and lower connector elements 34a, 34b and 36a, 36b. These connector elements 34a, 34b and 36a, 36b respectively sandwich or capture annulus tissue therebetween at each commissure. The connector elements 34a, 34b and 36a, 36b are each shown as "butterfly-type" connectors that may be slipped or inserted into place with native leaflet tissue sandwiched or secured therebetween. It will be appreciated that other tissue trapping connectors may be used instead, and/or other penetrating or non-penetrating connectors. Non-penetrating connectors are advantageous because they cause no damage that would otherwise occur due to penetrating connectors, and they allow for position adjustment. The frame structure <NUM> further includes first and second membrane support members <NUM> at opposite ends configured to be located in the left ventricle <NUM> to support a flexible membrane <NUM> in a slightly open condition. Together with the frame structure <NUM>, the flexible membrane <NUM> forms a selective occlusion device that works in conjunction with the native mitral valve leaflets 16a, 16b to control blood flow through the mitral valve <NUM>. The flexible membrane <NUM>, in this embodiment acts as a prosthetic heart valve by moving in coordination with the leaflets 16a, 16b as will be described below. In other embodiments, the selective occlusion device need not have any moving part that moves in conjunction with the leaflets 16a, 16b. The flexible membrane <NUM> is secured at opposite portions of the frame structure <NUM> to the support members <NUM>, <NUM> in any suitable manner, such as adhesive, mechanical securement, suturing, fasteners, etc. As further shown, a considerable portion at a lower margin of the flexible membrane <NUM> is not attached to the frame structure <NUM>. The membrane support members <NUM>, <NUM> are short, curved members and remaining membrane portions at the lower margin of the flexible membrane <NUM> are not directly attached to any frame portion. This allows the flexible membrane to billow, expand or inflate outward as will be discussed further below during systole to engage with the native leaflets 16a, 16b and prevent regurgitation of blood flow in a reverse direction through the mitral valve <NUM> when the heart cycle is in systole.

The flexible membrane <NUM> may be formed of various types of thin, flexible materials. For example, the materials may be natural, synthetic or bioengineered materials. Materials may include valve tissue or pericardial tissue from animals, such as cows and pigs, or other sources. Synthetic materials such as ePTFE, Dacron, Teflon or other materials or combinations of materials may be used to construct the flexible membrane <NUM>. Flexibility of the frame structure <NUM> together with the flexibility of the flexible membrane <NUM> provides for operation of the selective occlusion device <NUM> and the manners contemplated herein, and may also help prevent failure due to fatigue from repeated cycling movement of the selective occlusion device <NUM> in the heart <NUM>. It will be appreciated that <FIG> shows the flexible membrane <NUM> removed for a clear view of the frame structure <NUM>, and in this figure the flexible membrane <NUM> is in broken lines, while in <FIG> the flexible membrane <NUM> is shown in solid lines, with the heart cycle in systole and the flexible membrane <NUM> fully engaging the native leaflets 16a, 16b to reduce regurgitation of blood flow through the mitral valve <NUM>. The flexible membrane <NUM> may be sutured to the frame structure <NUM> using techniques employed by the prosthetic heart valve industry for the manufacture of prosthetic aortic and mitral valves. The frame may be made from one or more layers of material, such as super-elastic or shape memory material and the membrane <NUM> may be suitably secured. One manner may be trapping the flexible membrane <NUM> between layers of the frame structure <NUM>. To retain the membrane <NUM> in place, fabric covering(s) (not shown) over a metallic frame may aid in attaching the membrane <NUM> to the frame structure <NUM>.

<FIG> and <FIG> are transverse cross-sections through the selective occlusion device <NUM> and the mitral valve <NUM> shown in <FIG>. <FIG> illustrates the device <NUM> in a cross section along line 2A-2A of <FIG>, while <FIG> shows the selective occlusion device <NUM> in cross section along line 2B-2B of <FIG>, with each of these two figures showing the heart cycle in systole. <FIG> are top views respectively showing the systole and diastole conditions, but not illustrating the hinge 32a that may be provided to assist with folding during delivery. <FIG> is similar to <FIG> but showing the selective occlusion device <NUM> when the heart cycle is in diastole. In systole (<FIG> and <FIG>), which is when the native mitral valve <NUM> is supposed to fully close to prevent blood flow back into the left atrium <NUM>, the pressurized blood will flow through the open end <NUM> of the flexible membrane and be prevented from flowing through the closed end <NUM>, at least to any substantial degree. As will be appreciated from a review of some embodiments, a small vent may be provided in the flexible membrane. Because the flexible membrane billows or expands outwardly in the direction of the arrows shown in <FIG>, the native mitral leaflets 16a, 16b will seal against or coapt with the flexible membrane <NUM> to prevent blood flow regurgitation. In this manner, native mitral leaflets 16a, 16b that would not otherwise properly seal together or coapt will seal in systole against the flexible membrane <NUM>. To ensure coaptation, one or more portions of the flexible membrane <NUM> adjacent to frame structure <NUM> will move away from the adjacent frame structure into contact with the native leaflet(s) 16a, 16b. In other words, only a portion of the lower margin of the flexible membrane <NUM> is affixed to frame structure <NUM>. As further shown in <FIG>, there may be extra membrane material adjacent the membrane support members <NUM>, <NUM> to allow for the expanded membrane condition. As further shown in <FIG> and <FIG>, when the heart cycle is in diastole and blood flow needs to occur from the left atrium <NUM> into the left ventricle <NUM> (during the filling portion of the heart cycle), the blood will push past the flexible membrane <NUM> and the flexible membrane <NUM> will move into a collapsed or contracted condition while the native mitral 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 arch-shaped membrane support members <NUM>, <NUM> maintain a separation between lower margins or edges of the flexible membrane <NUM> to force blood to fill the inside or interior of the membrane <NUM> during systole through the open end <NUM>, causing the membrane <NUM> to expand or billow outward so that the membrane <NUM> fills the gap between the native mitral valve leaflets 16a, 16b. The arch-shaped or curved support members <NUM>, <NUM>, and/or other portions of the frame structure <NUM>, may be formed using a central wire and a fabric cover around the wire. Other constructions are possible as well, such as using soft, sponge-like material, and fabrics in conjunction with more structurally supportive material such as metal and/or plastic. The filling and emptying of the flexible membrane <NUM> through the open end <NUM> can ensure that there is washing or rinsing of the underside of the membrane <NUM> with each heartbeat to prevent clot formation, and any resulting embolization of clot material.

<FIG> are respectively similar to <FIG> and <FIG>, but illustrate the selective occlusion device <NUM> isolated from the native mitral valve <NUM> (<FIG> and <FIG>).

<FIG> illustrate another embodiment of a selective occlusion device 22a. As previously stated, all like reference numerals between the various embodiments and figures refer to 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 a prime mark (e.g., <NUM>'), indicating a modification to the like structure which will be discussed and/or apparent from a review of the drawings. To be more concise, redundant descriptions of like structure and function between the various figures will not be made or will be kept to a minimum. This embodiment is particularly suited to achieve beneficial effects for those mitral valve repairs involving clipping or otherwise securing one native leaflet margin to another. It will be appreciated, though, that clips or other anchors (herein generically referred to as clip structures) may be applied to only one leaflet margin, and more than one clip or anchor may be used. Often, mitral valve repair is made with a clip structure <NUM> having first and second clip elements 50a, 50b movable toward each other from an open condition to a closed position. The clip structure <NUM> is typically applied in a transcatheter procedure using a suitable catheter assembly <NUM>. A representative and illustrative clip structure <NUM> is shown in these figures for clipping together margins of the native leaflets 16a, 16b near a central location of each margin. The beginning of the procedure is shown in <FIG> with the catheter assembly <NUM> directed transeptally into the left atrium <NUM> through the inter-atrial septum 12a and into the mitral valve <NUM> and to the left ventricle <NUM>. A portion of the margin of each leaflet 16a, 16b is captured by the clip structure <NUM> and then clipped and firmly secured together as shown in <FIG>. At least one of the elements 50a, 50b moves toward the other in a clipping or clamping action to change from an open condition to a closed condition. A wire, suture or other tensile member or connector <NUM> is coupled to the clip structure <NUM>. At or near the end of the clipping step of the method, a selective occlusion device 22a in the form of a frame structure 30a and flexible membrane 44a (<FIG>) is introduced through the catheter or catheters <NUM> in a manner similar to the method described above with respect to the first embodiment. The selective occlusion device 22a is guided by the suture, wire or other tensile member <NUM> affixed and extending from the clip structure <NUM>.

As further shown in <FIG>, this embodiment of the device 30a, 44a includes two sections <NUM>, <NUM>. This embodiment advantageously utilizes the clip structure <NUM> as an anchoring mechanism for assisting with securing the device 30a, 44a in place and implanted as a selective occlusion device 22a in the native mitral valve <NUM>. The two sections <NUM>, <NUM> are employed in a manner described above in connection with the single section embodiment of the device <NUM>, <NUM>. As will be appreciated from a review of <FIG> and <FIG>, a modified frame structure 30a is employed to support a modified flexible membrane 44a. More specifically, the flexible membrane 44a includes corresponding sections 44a1 and 44a2. These may be formed from one or more distinct pieces of membrane material. In addition, third and fourth membrane support members <NUM>, <NUM> are provided to support the flexible membrane sections 44a1 and 44a2 in manners similar and analogous to the manner that support members <NUM>, <NUM> support and function in the first illustrative embodiment discussed above. An arc-shaped frame member <NUM> is shown similar to the first embodiment spanning across the native valve <NUM>. Vertical support members <NUM>, <NUM> extend from the frame member <NUM> and couple with the membrane support members <NUM>, <NUM>. As another option, the frame member <NUM> may be eliminated and the vertical members <NUM>, <NUM> or other structure could be joined together in the central region of the device 22a.

As further shown best in <FIG>, the suture or wire <NUM> couples the clip structure <NUM> to the frame structure 30a, such as by using a crimp element or other securement <NUM> generally at hinge 32a. It will be appreciated that other securement methods and structures may be used instead to secure the clip structure <NUM> to the frame structure 30a. The clip structure <NUM> and the frame structure 30a may take other forms than the illustrative forms shown and described herein. Use of the clip structure <NUM> securing the frame structure 30a in addition to the non-penetrating and/or other connectors such as generally at the native annulus 16c provides for an overall secure implant. The clip structure <NUM> and one or more annulus connectors will provide opposing forces that firmly secure the frame structure 30a and flexible membrane 44a generally therebetween. The two separate selective occlusion or flow control sections 44a1, 44a2 are separated from each other by the clip structure <NUM>. The attachment of the selective occlusion device 22a to the native mitral valve <NUM> may be a direct connection between the flexible membrane 44a and the native leaflets 16a, 16b (see below). Another option is that instead of the single arch-type frame member <NUM>, the two side-by-side sections <NUM>, <NUM> of the frame structure 30a may be otherwise coupled together near the center of the selective occlusion device 22a to avoid the need for a continuous frame member <NUM> spanning across the native mitral valve <NUM>. Still further modifications are possible, while retaining advantages of a clip structure used in combination with a selective occlusion device. For example, the selective occlusion device may be configured as a frame structure and flexible membrane affixed around a continuous perimeter portion of the frame structure.

<FIG> illustrate additional embodiments of selective occlusion devices 22b and 22c. In these figures the flexible membrane 44a is shown in broken lines so that the respective frame structures 30b, 30c are more clearly shown. In the illustrative embodiment of <FIG>, the central hinge has been eliminated and the suture or wire <NUM> extends directly through the frame member <NUM>. As with all embodiments, the devices 22b, 22c and any associated components, such as the frame structures 30b, 30c, may be made flexible enough and foldable into a collapsed condition for catheter delivery purposes. Again, a crimp element (not shown) or any other fixation manner may be used to secure the wire or suture <NUM> in tension against the frame structure 30b, 30c. <FIG> illustrates an embodiment of the selective occlusion device 22c slightly different from the embodiment of <FIG> in that the flexible membrane 44a, shown in broken lines, is folded inwardly at the region of the clip structure <NUM>. As shown in <FIG>, and as one additional option, the flexible membrane 44a may be more distinctly attached to the frame members as shown by the broken lines extending upwardly against the vertical frame members <NUM>, <NUM>.

<FIG> are top views illustrating selective occlusion device 22c, such as shown in <FIG> having separate sections 44a1 and 44a2 secured in place and implanted within a native mitral valve <NUM>. <FIG> shows the selective occlusion device 22c when the heart cycle is in diastole, and <FIG> shows the selective occlusion device 22c when the heart cycle is in systole. The function of a multi-section apparatus, such as with devices 22a, 22b, 22c, is similar to the function of the single section selective occlusion device <NUM> discussed above in connection with the first illustrative embodiment, except that with the native mitral valve itself separated into two sections by the clip structure <NUM>, the separate flexible membrane sections 44a1 and 44a2 independently function to contract or collapse in diastole (<FIG>) and billow, expand or inflate outwardly in systole (<FIG>) due to the forceful introduction of blood flow when the heart cycle is in systole. The effect or result is similar to that described above in connection with, for example, <FIG>, but with the dual effect of correcting any misalignment or lack of coaptation between the native mitral leaflets 16a, 16b on each side of the clip structure <NUM>. In this manner, blood flow is allowed in diastole as shown in <FIG> past the native mitral leaflets 16a, 16b which have spread or expanded outwardly and also past the two section flexible membrane 44a which has collapsed inwardly or away from the native mitral leaflets 16a, 16b. Reverse or regurgitated blood flow is at least reduced, if not reduced to essentially zero (prevented), during systole as the flexible membrane 44a expands or inflates to contact or engage the native mitral leaflets 16a, 16b creating a fluid seal.

<FIG> shows a side view of the selective occlusion device 22c shown in <FIG>, but with the flexible membrane 44a shown in broken lines for clarity. The selective occlusion device 22c is securely implanted in the mitral valve <NUM> between annulus connectors <NUM>, <NUM> generally at an upper location and a clip structure <NUM> at a lower location. Again, different connector and/or clip configurations may be used than those shown and described, and different numbers of connectors and clip structures may be used. The clip structure or structures may be secured to each leaflet 16a, 16b simultaneously as shown, or may be secured separately to a single leaflet 16a and/or 16b. Although the tensile member <NUM> is shown to have a particular length to connect between the clip structure <NUM> and the frame member <NUM>, a tensile member or other type of connection of any necessary longer or shorter extent may be used instead. In some cases, the clip structure <NUM> may be directly affixed to the frame structure <NUM>.

<FIG> illustrates a selective occlusion device 22d constructed according to an illustrative embodiment, in which an alternatively configured frame structure 30d is used and coupled with a flexible membrane <NUM> (shown in broken lines for clarity. Particularly, lower supporting members <NUM>, <NUM>, <NUM>, <NUM> have a different configuration for guiding the shape of the flexible membrane <NUM>. The flexible membrane <NUM> may be securely attached to the lower supporting members <NUM>, <NUM>, <NUM>, <NUM> along their entire lengths, or along a portion of their lengths, or not at all if they are otherwise held in place during diastole in a suitable manner. The lower margins of the flexible membrane <NUM> are allowed to billow or expand outwardly and may be detached from the lower supporting members <NUM>, <NUM>, <NUM>, <NUM> along at least substantial portions to allow this expanding or billowing action to take place. In addition, the entire frame structure 30d and/or only the lower supporting members <NUM>, <NUM>, <NUM>, <NUM> may be highly flexible to allow this expansion or billowing action to take place when the heart cycle is in systole, as previously described.

<FIG>, <FIG> and <FIG> show another illustrative embodiment in which a transcatheter system <NUM> is used and, specifically, a clip structure capturing device <NUM> is used to help secure the selective occlusion device 22a in place. This may be particularly useful when applying a selective occlusion device such as according to the present disclosure to a previously implanted mitral clip structure <NUM>. The clip structure <NUM> may be of any type or configuration. In cases where the clip structure <NUM> has failed to properly repair the mitral valve <NUM>, or the mitral valve function has degraded over time, despite the clip repair procedure, this embodiment assists with the capturing of the previously implanted clip structure <NUM> and implantation of a selective occlusion device, such as frame structure 30a and flexible membrane 44a. In this regard, and as shown in <FIG> and <FIG>, a lasso or suture loop device <NUM> is deployed from a catheter <NUM> and captures the clip structure <NUM> with assistance from a guide device <NUM>. The suture, wire or other tensile member <NUM> that extends upwardly through the mitral valve <NUM> may be a part of the suture loop device <NUM> in this embodiment and may then be used as generally described above to guide and securely affix selective occlusion device 22a, to the clip structure <NUM>, as shown in <FIG>. For clarity, the flexible membrane 44a has not been shown in <FIG>.

<FIG> illustrate two additional embodiments of selective occlusion devices 22e, 22f, without showing the flexible membranes, that may be used to prevent blood flow regurgitation through a heart valve such as, by way of example, the mitral valve <NUM>. In these embodiments, a flexible membrane 44a (<FIG>) may be secured over a frame structure <NUM>, <NUM>' from one end to the other, such as between two non-penetrating annulus connectors or, in other embodiments, penetrating connector portions <NUM>, <NUM>, <NUM>', <NUM>'. Advantageously, there are two spaced apart elongate frame members <NUM>, <NUM> extending between the connectors <NUM>, <NUM>, <NUM>', <NUM>', each having an upward bend or hump <NUM>, <NUM> creating a recessed space. As shown in <FIG> the flexible membrane 44a is carried on this frame structure <NUM>, <NUM>' and may be secured to the frame members <NUM>, <NUM> along all or some of the lengths thereof. This can leave a desired portion of the flexible membrane 44a at the lower margin of the frame structures <NUM>, <NUM>' unsecured and able to expand or billow in outward direction during systole, generally as described above in prior described embodiments or in later described embodiments. This outward expansion or billowing action will allow the flexible membrane <NUM> to better contact or engage the natural leaflet tissue during systole to prevent regurgitation of blood flow. This will also allow for more exchange of blood beneath or within the flexible membrane to prevent blood stagnation and the resulting possibility of clotting which may embolize and cause stroke or other complications. The humps <NUM>, <NUM>' in each of the lower, spaced apart support members <NUM>, <NUM> accommodate the clip structure <NUM> and generally receive that portion of the mitral valve <NUM> fastened together at the A2/P2 junction. A central connection element, such as a hole <NUM>, is provided in a central frame member <NUM> and allows a wire, suture or other tensile member <NUM> to attach the frame structure <NUM>, <NUM>' to the clip structure <NUM>. The central frame member connects the annulus connectors <NUM>, <NUM> and <NUM>', <NUM>' together and arches over and across the mitral valve <NUM> in a manner similar to frame member <NUM>. Suitable configurations of the frame structure <NUM>, <NUM>' may be used, such as any of those previously described, for accommodating one or more clip structures and forming a plurality of separate flexible membrane sections, for example, with one section on each side of a clip structure <NUM>. <FIG> also show another way of attaching a frame structure generally at the native annulus 16c with one or more holes <NUM>, <NUM>, <NUM>, <NUM> to engage with a suitable fixation element or anchor <NUM> (<FIG>). The embodiment of <FIG> includes two additional fixation holes <NUM>, <NUM> for receiving fasteners. In some embodiments such as shown in <FIG>, penetrating anchors may be used, such as rivets, T-bars, pledgets, or other fixation elements, although the benefits of non-penetrating connectors in accordance with this disclosure would be desirable, such as for purposes of allowing self-adjustment and reduced tissue damage.

<FIG> and <FIG> illustrate another illustrative embodiment of a selective occlusion device <NUM>. Rather than employing a flexible membrane, this apparatus includes at least one rigid occlusion element <NUM>. This embodiment is more specifically configured to operate in conjunction with mitral valve leaflets 16a, 16b that have been affixed together at a central location along their margins with a clip structure <NUM> such as a clip structure previously described. Therefore, two selective occlusion elements <NUM> are provided for reasons analogous to the two section flexible membrane embodiments described herein. The selective occlusion elements <NUM> are "rigid" in use within the mitral valve <NUM> in that they are static and need not flex inwardly or outwardly to engage and disengage the native mitral leaflets 16a, 16b during the systole and diastole portions of the heart cycle. Instead, these disk-shaped elements <NUM> retain their shape and are sized and located in the native mitral valve <NUM> such that the native mitral leaflets 16a, 16b engage the elements <NUM> during systole and disengage the elements <NUM> during diastole. This selective or cyclical interaction is shown in <FIG>, to be described further below. The device <NUM> shown in <FIG> and <FIG> includes a frame structure 30e that is configured to extend generally across the native mitral valve <NUM>, with a frame member <NUM> and hinge 32a as generally described in previous embodiments, along with non-penetrating annulus connectors <NUM>, <NUM> as also previously described. Further, the clip structure <NUM> is secured to the frame structure 30e with a crimp element <NUM> and a suture, wire or other tensile member <NUM>, such as in one of the previously described manners. In this way, the first and second rigid, selective occlusion elements <NUM> are respectively disposed on opposite sides of the native mitral valve <NUM> and on opposite sides of the clip structure <NUM> to selectively include the openings in the native mitral valve <NUM> formed when the clip structure <NUM> is affixed to each leaflet 16a, 16b bringing central portions of the two leaflet margins together either in direct contact with each other or in contact with a spacer (not shown) disposed between the movable clip elements. In this embodiment, the frame structure 30e is formed with it a curved or arch-type frame member <NUM> configured to extend over the native mitral valve <NUM> in the left atrium <NUM>.

The selective occlusion device <NUM> is shown when the heart cycle is in systole in <FIG>, <FIG> and <FIG>. The native anterior and posterior mitral valve leaflets 16a, 16b are shown being forced inwardly toward each other. There is no blood leak or regurgitation because the static occlusion elements <NUM> fill any residual gap between the anterior and posterior leaflets 16a, 16b. The elements <NUM> do not need to be of the depicted shape. Any shape of space filling would be sufficient if the gap between the two leaflets 16a, 16b is filled by the elements <NUM>. The best shape could be determined at least partly by studying the shape of the gap between the native mitral valve leaflets 16a, 16b in systole after a clip structure <NUM> has been applied. The optimal shape for the elements <NUM> for a particular patient anatomy may even be custom manufactured for that patient with rapid manufacturing techniques. Advantages of using rigid/static element(s) <NUM> include their ability to withstand repeated cycling forces perhaps better than a design that relies on one or more moving valve elements that may be more susceptible to fatigue.

<FIG> more particularly shows a cut away view of the mitral valve <NUM> from commissure to commissure. At the commissures, the anchors or connectors <NUM>, <NUM> are shown on each side - both above and below the leaflets 16a, 16b. Centrally, there is a clip structure <NUM> or other attachment that anchors to the mitral valve leaflets 16a, 16b either individually or together. A tensile or other connecting member <NUM> extends up from the clip attachment component <NUM> and attaches to the frame member <NUM> which extends across the valve <NUM> from commissure to commissure.

The frame structure 30e can be constructed of a metal material such as stainless steel or Nitinol. Nitinol or other shape memory or super-elastic material may be preferred as this can be collapsed for delivery via a catheter device inside the heart, and then expanded inside the heart for implantation.

The element(s) <NUM> may be constructed in a number of ways and have various shapes. They could be composed of a frame of metal such as Nitinol that could be collapsed for catheter delivery. The metal frame could be covered by a plastic material or other artificial material like silicone or Teflon or polyurethane. Animal or human pericardium and animal or human heart valve material or any of the materials typically used for heart valve leaflet construction could be used to cover the frame structure 30e. A synthetic material or bioengineered material could also be used to cover the frame structure 30e.

The inside of the static occlusion elements <NUM> could be hollow. Or, a bladder or sac could be inside to fill the hollow interior space of the element(s) <NUM>. The bladder could be filled with air or any gas or a liquid such as saline, sterile water, blood, antibiotic or antiseptic fluid, polymer or curable fluid material. The use of a bladder to fill the inside of the element <NUM> could eliminate the need or reduce the need for a frame associated with the element <NUM>.

The selective occlusion device <NUM> has commissural and leaflet attachments to anchor it in position. It would also be possible to create this apparatus without a leaflet attachment. For example, the attachment could be at the commissures only. It would not be necessary to have a clip structure <NUM> and a member connected to the frame member <NUM>. In this case there would not need to be two occluding elements <NUM>. A single occlusion element <NUM> could be used to fill any gap between the two leaflets 16a, 16b. The shape of course would be different - likely an oval surface to extend between the commissures. The frame of such an element could be similar to that previously shown and described in connection with the first embodiment or another configuration.

<FIG> shows another illustrative embodiment or variation of a selective occlusion device <NUM> mounted inside the heart to the native mitral valve <NUM>. There are two selective occluding elements <NUM> attached to a frame structure 30f. The frame structure 30f is engaged with a clip structure <NUM> that is attaching the anterior and posterior leaflets 16a, 16b together centrally, e.g., near the A2/P2 junction. The frame structure 30f is stabilized by connectors <NUM>, <NUM> at the commissures and annulus region 16c of the valve <NUM>.

The embodiment of <FIG> is similar to that shown in <FIG> and <FIG>. The difference here is that the support frame member <NUM> is not located above the elements <NUM> but below the elements <NUM>. In other embodiments the support frame member <NUM> is located above the selective occlusion device and been directed to the left atrium. In this embodiment, the supporting frame member <NUM> is biased downward and toward the left ventricle, generally below the mitral valve <NUM>. Also, in this embodiment, the frame member <NUM> can be directly connected to the clip structure <NUM> that attaches the two leaflets 16a, 16b and the frame structure 30f together. This may allow a procedure where the entire device is implanted at one time. The clip structure <NUM>, with the selective occlusion device elements <NUM> coupled to frame structure 30f, could be delivered by a catheter (not shown). The clip structure <NUM> (with or without exposing the rest of the device) could be extruded outside the delivery catheter inside the heart <NUM>. The clip structure <NUM> may then be closed on the native mitral valve anterior and posterior leaflets 16a, 16b. The remainder of the selective occlusion device <NUM> could be then released from the delivery catheter - placing the entire device in position. This may simplify the procedure to one step.

It is also important to note that in prior embodiments the frame structure has been above the clip structure <NUM>, and in this embodiment, the frame structure 30f is below. It is also possible to have both an upper and a lower support frame structure (such as by combining two arc-shaped supports in one device). It would also be possible to join upper and lower arc support or frame members, so the support or frame structure is a complete loop or circle. This may provide further structural strength to the system.

<FIG> is a side elevational view schematically illustrating another illustrative embodiment of a selective occlusion device 22i including first and second rigid or static selective occlusion elements <NUM> coupled with a frame structure <NUM>. In this embodiment, the rigid selective occlusion elements <NUM> are directly coupled to the frame structure <NUM>, which may be a frame member <NUM> coupled with the clip structure <NUM>. As in previous embodiments, the clip structure <NUM> may directly couple respective margins of the anterior and posterior mitral leaflets 16a, 16b, or may couple these leaflet margins together against an intermediate spacer (not shown). This may be used to correctly orient and locate the rigid selective occlusion elements <NUM> on opposite sides of the clip structure <NUM> and within the side-by-side openings of the native mitral valve <NUM> created by the central clip structure <NUM>. Optionally, additional connectors <NUM>, <NUM> shown in broken lines may be used to help secure the rigid selective occlusion elements <NUM> in place at the commissures of the mitral valve <NUM>.

<FIG> schematically illustrate, in cross section, the functioning of the rigid, selective occlusion elements <NUM> shown in <FIG>. Specifically, when the heart cycle is in systole the native mitral leaflets 16a, 16b will close against the rigid selective occlusion elements <NUM> to provide a fluid seal against regurgitation of blood flow. As shown in <FIG>, during diastole, the mitral valve leaflets 16a, 16b will spread apart and disengage from the rigid selective occlusion elements <NUM> to allow blood flow from the left atrium <NUM> into the left ventricle <NUM> between the rigid selective occlusion elements <NUM> and the respective native leaflets 16a, 16b. The one or more elements <NUM> fill any gap between the anterior and posterior leaflets 16a, 16b. When mitral regurgitation occurs due to failure of complete leaflet coaptation, the leaflets 16a, 16b are frequently pulled apart from each other in the plane of the valve <NUM> (here left-right). However, the situation may become more complex because the leaflets 16a, 16b tend to be pulled down into the ventricle <NUM> as well as apart from each other as mitral regurgitation becomes more severe over time. So, an up/down gap may also occur with one leaflet 16a or 16b sitting at a higher plane than the other leaflet 16a, 16b.

The advantage to a convexly curved outer surface of the element(s) <NUM> is that this surface can be shaped to adapt to a wide variety of defects that may occur between the anterior and posterior leaflets 16a, 16b. An outer, convexly curved surface of the element(s) <NUM> can accommodate leaflet gaps that are in the plane of the valve <NUM> (left right in the figure) and perpendicular to the plane of the valve <NUM> (up and down in the figure).

The selective occlusion device <NUM> is symmetric on each side. The elements <NUM> could also be constructed so that they are asymmetrical, i.e., not identical on opposite sides. For example, the posterior leaflet 16b may be more retracted into the left ventricle <NUM> than the anterior leaflet 16a. It may be useful to have adjustments in the element <NUM> on the side facing the posterior leaflet 16b to fill the gap left by a retracted posterior leaflet 16b. The element <NUM> may be constructed to be more prominent on the side of the element <NUM> adjacent to the posterior leaflet 16b than on the side adjacent or facing the anterior leaflet 16a. One or more elements <NUM> may be adjustable in shape, such as by an adjustable level of inflation to a hollow interior of the element <NUM> or other method, to accommodate any need to fill a gap between the leaflets 16a, 16b that would otherwise cause regurgitation.

Custom made or custom size elements <NUM> could also be made depending on the shape of the gap. A gap could be determined by echocardiography or CT and appropriately sized and shaped filling elements <NUM> could be selected based on measurements obtained with imaging. The valve defect that needs repair may be more shaped as a cylinder and a cylinder or pyramid-cylinder shape may be better to stop blood regurgitation than a lens or disc shape for the element(s) <NUM>.

The margins of the element(s) <NUM> facing the oncoming flow of blood from the left atrium <NUM> has a tapering surface. This will allow the blood to flow smoothly into the left ventricle and avoid blood damage or hemolysis and to promote complete and unimpeded filling of the left ventricle <NUM>. The edge of the element(s) <NUM> inside the left ventricle <NUM> also demonstrates a taper similar to the inflow region of the element(s) <NUM>. When the heart begins to contract, blood will be ejected back toward the element(s) <NUM> and the native leaflets 16a, 16b will begin to move toward the element(s) <NUM> to produce a complete seal - preventing regurgitation of blood during systole.

An additional option is provided and illustrated in <FIG>. The rigid selective occlusion element(s) <NUM> may be formed in a fluid efficient manner, such as a teardrop shape or other hemodynamic shape to prevent undesirable blood flow patterns and damage or hemolysis as the blood flows past the elements <NUM> in between the element <NUM> and the respective mitral leaflets 16a, 16b.

<FIG> and <FIG> illustrate additional embodiments of selective occlusion devices 22j, <NUM>, <NUM> that utilize rigid or static selective occlusion elements <NUM>. These elements <NUM> function as discussed above in connection with <FIG> and <FIG>. In <FIG> the rigid or static selective occlusion elements <NUM> are coupled to a frame structure <NUM> that is secured along top margins of the elements <NUM>. At each end of the frame structure <NUM> respective commissure connectors <NUM>, <NUM> are provided that include connecting elements which operate the same as the butterfly type elements previously described by sandwiching mitral tissue or other heart tissue therebetween. Additional securement is provided by the clip structure <NUM> and a suitable tensile element or other connector <NUM>, such as also previously described.

<FIG> illustrates an embodiment of a selective occlusion device <NUM> in the form of rigid or static elements <NUM> that are again generally disc shaped and secured together by a frame member <NUM>', a tensile element or connector <NUM> and a connected a clip structure <NUM>.

<FIG> illustrates an embodiment of a selective occlusion device <NUM> in which the rigid selective occlusion elements <NUM> are secured together by fabric or other structure <NUM>, and further secured through a tensile member or other connector <NUM> to a clip structure <NUM> which secures the selective occlusion device <NUM> to the native mitral valve <NUM> through a clipping action as previously described.

<FIG> illustrate another embodiment of a of a selective occlusion device <NUM> including a flexible membrane 44a and a frame structure 30i. The flexible membrane 44a is secured to frame structure 30i that is also preferably flexible for reasons such as previously described. This embodiment is similar to previous embodiments utilizing flexible membranes 44a in conjunction with a mitral valve clip structure <NUM>, but includes a central reinforced area such as a fabric area <NUM> allowing the native leaflet margin tissue to be a clipped against the reinforced fabric area <NUM> directly. The clip structure <NUM> is shown in broken lines in <FIG>. In this alternative, the native mitral tissue is not directly contacting abutting native mitral tissue but instead contacts and is secured against the reinforced central fabric area <NUM> of the flexible membrane 44a. This fabric or other reinforcing material <NUM> may, for example, be useful in situations where the remainder of the flexible membrane is formed from more delicate material such as biologic material. Annulus connectors <NUM>, <NUM> are provided and rest against an upper portion of the annulus 16c as generally shown in other figures, such that the clip structure <NUM> (not shown in this embodiment) secures the selective occlusion device <NUM> to the reinforced, central area <NUM> from below, and the annulus connectors <NUM>, <NUM> secure the selective occlusion device <NUM> from above by bearing against or otherwise coupling to the native annulus 16c.

<FIG> illustrate another illustrative embodiment of a transcatheter delivered selective occlusion device 22n combined with a clip structure <NUM>. Again, the clip structure <NUM> is used to affix a lower central margin portion of one leaflet 16a to a lower central margin portion of the opposing leaflet 16b, generally as previously described. Again, this clipping action may be for purposes of clipping the anterior leaflet 16a directly in contact with the posterior leaflet 16b at the central location, or clipping the anterior and posterior leaflets 16a, 16b against an intermediate spacer. In this embodiment, the selective occlusion device is coupled with the clip structure <NUM> delivered through one or more catheters <NUM>. As shown in <FIG> and <FIG>, the catheter assembly <NUM> is delivered transeptally into the left atrium <NUM> and downwardly through the native mitral valve <NUM> although other approaches may be used instead in the various embodiments. The clip structure <NUM> is extruded from the catheter assembly distal end and, in the open condition shown in <FIG> captures the leaflet margin portions as shown in <FIG> and is actuated to move one or both clip elements 50a, 50b together into the position shown in <FIG> to secure the central leaflet margin portions together. The remaining portion of the selective occlusion device 22n is then extruded from the distal end of the catheter assembly <NUM> as shown in <FIG>. As shown in <FIG> the selective occlusion device 22n, which may be, as illustrative examples, of the type shown in <FIG> or any of the types otherwise shown and described herein, or even other configurations contemplated hereby, self-expands into the mitral valve location. Operation of the selective occlusion device 22n may be generally as described herein, and securement of the device 22n occurs generally between the clip structure <NUM> and respective annulus connectors <NUM>, <NUM>. Specifically, as previously discussed, the annulus connectors <NUM>, <NUM> provide a downward force for securing the device 22n generally at the annulus 16c, while the clip structure <NUM> provides an upward force to generally secure the selective occlusion device 22n therebetween in place in the native mitral valve <NUM>.

<FIG> illustrate an embodiment of an apparatus for transcatheter delivery and implantation. In this embodiment, the clip structure <NUM> is delivered below the mitral valve <NUM> generally as previously described, and the selective occlusion device 22n is delivered to a location above the native mitral valve <NUM>. The selective occlusion device 22n is inserted into the mitral valve <NUM> and between the native leaflets 16a, 16b, and also between the clip elements as shown in the method proceeding from <FIG>. Once in position as shown in <FIG>, at least one of the clip elements is moved toward the other clip element to clip or clamp the leaflet margins together, as previously described, and also to clamp a lower central portion of the selective occlusion device 22n and, particularly, the flexible membrane 44a in this embodiment, such that the leaflet margins are secured together at the same time as the selective occlusion device 22n is secured and implanted in place within the native mitral valve <NUM>. As shown in <FIG>, the selective occlusion device 22n is fully extruded from the catheter assembly, whereupon it self-expands into position in the native mitral valve <NUM> and functions as otherwise generally discussed herein. More particularly, <FIG> illustrate the diastole and systole portions, respectively, of the heart cycle with the apparatus secured in place as described in connection with <FIG>. In <FIG>, during diastole, blood flow is allowed between the native mitral leaflets 16a, 16b and the flexible membrane 44a, while in systole the flexible membrane 44a, in each section, fills with blood and thereby expands or inflates as the mitral leaflets 16a, 16b move toward one another and against the flexible membrane 44a to form a fluid seal preventing regurgitation of blood flow from the left ventricle <NUM> into the left atrium <NUM> of the heart <NUM>.

<FIG> is an anatomical view from above the native mitral valve <NUM> with the selective occlusion device 22n superimposed to show another representation for the configuration in which the selective occlusion device 22n is curved and flexes in accordance with the natural curvature of the mitral valve <NUM>.

<FIG> illustrate another embodiment for a selective occlusion device 22o and apparatus (combining the device 22o with a clip structure <NUM>), in which the selective occlusion device 22o is configured generally as a two section device, but with the sections in fluid communication as best shown in <FIG>. A clip structure <NUM> is secured to the selective occlusion device 22o at a position between respective open ends <NUM>, <NUM> of the sections. The clip structure <NUM> is used in the same manner as previously described. The flexible membrane 44b is supported by a flexible but strong frame structure <NUM>, which may be formed in any manner contemplated herein, such as for allowing transcatheter delivery and implantation. The open ends <NUM>, <NUM> are defined by hoop or ring portions <NUM>, <NUM> of the frame structure <NUM>. The hollow interior <NUM> of a flexible membrane 44b receives blood flow in the systole portion of the heart cycle and fluid communication between the two openings <NUM>, <NUM> ensures better rinsing or washing during the heart cycle to reduce the chances of blood clots.

<FIG> illustrate another embodiment of an apparatus for transcatheter delivery and implantation of a clip structure <NUM> coupled with a selective occlusion device 22p. A difference with this embodiment is that the clip structure <NUM> clips the native mitral leaflets 16a, 16b against a central or intermediate spacer <NUM>, instead of directly into contact with each other. The procedure is generally shown in <FIG> in which the clip structure <NUM> is first extruded from the transeptally directed catheter assembly <NUM> generally at a location below the mitral leaflets 16a, 16b. The leaflets 16a, 16b are captured against the intermediate spacer <NUM>, as shown in <FIG>. The leaflets 16a, 16b are secured firmly against the spacer <NUM> as shown in <FIG> 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 <NUM> to clamp leaflet tissue against the spacer <NUM>. The selective occlusion device 22p, in this illustrative embodiment, is already secured to the clip structure <NUM> when it is extruded from the catheter assembly <NUM> as illustrated in <FIG> whereupon the selective occlusion device 22p self-expands into the implanted condition shown in <FIG>. It will be appreciated that the selective occlusion device 22p may be extruded and implanted as a separate component, as well as coupled to the clip structure <NUM> in a suitable manner, instead of being extruded in an already assembled form from the catheter or catheters <NUM>.

<FIG> illustrates another embodiment, similar to that shown in <FIG>, but further illustrating respective annulus connectors <NUM>, <NUM> as part of the selective occlusion device 22p in the form of frame members that bear against heart tissue generally at the annulus 16c in the left atrium <NUM> and, additionally or optionally, frame members or connectors <NUM>, <NUM> (shown in broken lines) coupled with the selective occlusion device 22p and located in the left atrium <NUM> abutting the annulus 16c from below. Use of both sets of annulus connectors <NUM>, <NUM>, <NUM>, <NUM> results in sandwiching the heart tissue therebetween for better securement.

<FIG> illustrates another embodiment of a device 22q, similar to <FIG>, but illustrating a single annular connector <NUM> generally encircling the native mitral valve <NUM> formed as part of the selective occlusion device and anchoring the selective occlusion device 22q in the native mitral valve <NUM> securely, preventing rocking in any direction but allowing flexibility. As with all embodiments, the frame members may be formed of any desired material, such as flexible wire-like materials formed from polymers and/or flexible metals including super-elastic or shape memory materials. This can help achieve overall goals of the embodiments of flexibility for collapsed delivery and improved operation during implanted use, as well as resistance against failure due to fatigue in this application involving continuous cycling in the heart.

<FIG> illustrates another embodiment of a device 22r. The selective occlusion device 22r may be as described in connection with any other embodiment, but for illustrative purposes, is shown with a hollow flexible membrane 44b, while the frame structure has been modified as shown. The frame structure includes a generally annular frame member <NUM> such as described and shown in connection with <FIG>, but including raised portions 170a, 170b relative to other portions. The raised portions 170a, 170b are configured to be located adjacent and above the commissures of the native mitral valve <NUM> and are connected with a central frame member <NUM> extending generally across the native mitral valve <NUM> and formed as part of the selective occlusion device 22r such as with another connecting frame member <NUM>. Such frame members at the annulus, as with all embodiments, may be above the annulus, below the annulus, or frame members/connectors may be above and below the annulus to sandwich tissue therebetween.

<FIG> schematically illustrate a selective occlusion device <NUM> coupled with a central clip <NUM> including a spacer <NUM> implanted in a mitral valve <NUM>. <FIG> illustrates the device <NUM> and the mitral valve <NUM> when the heart cycle is in systole, while <FIG> illustrates the mitral valve <NUM> and the selective occlusion device <NUM> when the heart is in diastole. The frame structure includes respective hoops or rings <NUM>, <NUM> as shown in solid lines in <FIG> and broken lines in <FIG>. These define the openings <NUM>, <NUM>. A benefit of this frame configuration is that the frame will not contact the commissures during repeated heart cycling. The device, like other embodiments allows blood flow from the left atrium to the left ventricle in diastole but prevents blood flow during systole.

<FIG> is a cross-sectional view schematically illustrating the mitral valve <NUM> and the implanted selective occlusion device <NUM>, coupled with a central clip structure <NUM> such as at a coupling <NUM>. The selective occlusion device <NUM> is of a type with a hollow interior <NUM> having two fluid communicating sections <NUM>, <NUM> and respective first and second openings <NUM>, <NUM> and a closed end <NUM>. Fluid communication between sections <NUM>, <NUM> allows for better rinsing and washing action and reduced chance of clotting.

<FIG> are schematic views of a selective occlusion device 22t, 22t' including a flexible membrane 44b, 44b' with <FIG> showing the selective occlusion devices 22t, 22t' when the heart cycle is in systole. The difference between the two devices 22t, 22t' is that the flexible membrane 44b' is integrated into the spacer <NUM> of the clip structure <NUM>, while the flexible membrane 44b is not. Flexible membrane 44b and/or another portion, such as a frame portion, of device 22t may be otherwise coupled to clip structure <NUM> such as in the manner shown in <FIG> or another suitable manner.

<FIG> and <FIG> schematically illustrate another illustrative embodiment of an apparatus including a central clip structure <NUM> (<FIG>) and a selective occlusion device 22u. The selective occlusion device 22u, as with previous devices shown and described herein, is a hollow fluid communicating structure having a flexible membrane 44b and allowing blood flow into the hollow interior <NUM> defined by the flexible membrane 44b in systole, as shown in <FIG> and <FIG>. In diastole, the flexible membrane 44b collapses inwardly, as previously shown and described, to allow blood flow past the selective occlusion device 22u and between the native mitral leaflets 16a, 16b from the left atrium <NUM> into the left ventricle <NUM>. In this embodiment, the orientation of openings <NUM>, <NUM> and shape of the device 22u force blood flow, in systole, toward the commissure regions as shown by the arrows. These forces help retain the device 22u in place, in addition to any other securement such as the clip structure <NUM>. In this way, rocking of the device 22u may be reduced and the device 22u can be more stable during implantation and use. These inlets <NUM>, <NUM> are angled acutely away from the central clip structure <NUM> as shown in <FIG>.

<FIG> illustrates another embodiment of a selective occlusion device 22v in which a suitable baffle structure <NUM> is provided within the selective occlusion device 22v for directing blood flow outwardly as shown by the arrows toward the connecting locations between the device 22v and the mitral annulus 16c. This helps to produce securement force and stabilization of the device 22v in the implanted condition. A single opening <NUM> is provided for in flow during systole and the device 22v includes a closed end <NUM> and a hollow interior <NUM>, such that the device 22v fills with blood during systole and collapses to expel the blood during diastole as previously shown and described. A frame structure <NUM> is provided to support a flexible membrane 44b, generally as previously described, except that the frame structure is shaped and configured differently so as to form the single opening <NUM> defined by a hoop or ring frame member <NUM>. It will be appreciated that the shapes and configurations of these structures may be modified from those shown in these illustrative examples.

<FIG> is an embodiment of a device 22w that may be configured as previous embodiments have been described, in terms of the selective occlusion device 22w, but which includes a generally annular or circular frame <NUM> structure that is a flat element for securing the apparatus in place in the mitral valve <NUM>. The frame structure <NUM> is shown to rest and/or be secured in the left atrium <NUM> abutting against heart tissue generally proximate the mitral annulus 16c. However, it will be appreciated that such a structure could be secured in other manners, and that an additional lower support may be provided to sandwich heart tissue therebetween.

<FIG> illustrate another embodiment of a selective occlusion device 22x which may be constructed in accordance with previous described embodiments, but including at least one small vent <NUM> opposite to the two openings <NUM>, <NUM> of the flexible membrane 44b. The vent <NUM> is not large enough to result in any significant regurgitation or leakage of blood in systole. To the extent that the vent <NUM> does not allow any significant regurgitation of blood, this end of the flexible membrane is closed while the opposite end includes at least one and, in this embodiment two openings <NUM>, <NUM>. Otherwise, this embodiment of the flexible membrane 44b operates and functions for purposes and in ways as previously shown and described. One or more vents <NUM> may, for example, provide a pressure relief to reduce the forces against the device 22x during high pressure systole portions of the heart cycle.

<FIG> illustrate another embodiment of an apparatus comprised of a central clip structure <NUM> and the previously described selective occlusion device 22p. In this embodiment, the clip structure <NUM> includes a central gripping structure <NUM> which may have tines or other knurled, roughened or frictional surfaces. This will assist with clamping and retaining mitral leaflet margin tissue between the respective clip elements 50a, 50b and the selective occlusion device 22p. The clip structure <NUM> is secured to the selective occlusion device 22p, such as via the central gripping element <NUM>. <FIG> further illustrate that the selective occlusion device 22p operates in the same manner, for example, as described above with fluid communication between two generally adjacent openings <NUM>, <NUM> for increased washing and rinsing.

<FIG> and <FIG> illustrate the apparatus shown in <FIG> in operation after being implanted in the mitral valve <NUM>. Specifically, blood enters the selective occlusion device 22p through the open ends <NUM>, <NUM> and fills the interior <NUM> defined by the flexible membrane 44b, whereupon the flexible membrane 44b expands or inflates to engage in contact with the native mitral leaflets 16a, 16b forming a fluid seal that prevents regurgitation of blood flow during systole (<FIG>). This is shown in <FIG> with the anatomy of the mitral valve <NUM> further shown and the native leaflet tissue contacting the outside surfaces of the flexible membrane 44b during systole.

<FIG> illustrates another embodiment showing an expandable prosthetic heart valve <NUM>, which may be comprised of a generally cylindrical outer or peripheral frame structure <NUM> and coupled with interior prosthetic leaflets <NUM> that open and close to control blood flow therethrough. This is different from the other versions of a selective occlusion device which have at least one movable valve element (e.g., the flexible membrane that operates in conjunction with a native mitral leaflet), in that this prosthetic heart valve <NUM> does not operate in conjunction with the native leaflet to control blood flow. Instead, the prosthetic leaflets <NUM> control blood flow through the prosthetic valve <NUM>. Coupled to the frame structure <NUM> are clip structures <NUM> or elements that directly couple the expandable prosthetic heart valve <NUM> to heart valve leaflets, such as the mitral valve leaflets 16a, 16b as previously shown and described. <FIG> is a side elevational view partially fragmented to show the internal stent structure <NUM> exposed underneath an outer covering <NUM>, which may be natural, synthetic, biologic, bioengineered, or any other suitable medical grade material useful for cardiac devices of this type.

<FIG> illustrate the succession of steps used to implant the prosthetic valve <NUM> of <FIG>. In particular, this apparatus may be implanted through a transcatheter procedure, or a more invasive procedures such as a surgical procedure or keyhole type or other less invasive procedure. The collapsed or folded apparatus <NUM> is inserted between the mitral valve leaflets 16a, 16b as shown in <FIG>, the clip structures <NUM> are used to capture the lower margins of the mitral leaflets 16a, 16b (<FIG>) and clamp them as shown in <FIG>. The expandable prosthetic heart valve <NUM> is then expanded against the native mitral leaflets 16a, 16b as shown in <FIG> to secure the implanted prosthetic heart valve <NUM> in place within the native mitral valve <NUM>. The prosthetic leaflets <NUM> then open and close, respectively during diastole and systole to allow and prevent the flow of blood through the prosthetic heart valve <NUM>.

<FIG> illustrates another embodiment, similar to the previous embodiment shown in <FIG>, but adding an upper flange element <NUM> that helps secure the prosthetic heart valve <NUM> by stabilizing the heart valve <NUM> within the left atrium <NUM>. In this regard the flange <NUM> is mounted above the native mitral valve <NUM>. The flange <NUM> may abut against heart tissue in the lower portion of the left atrium <NUM>. <FIG> is a side elevational view of the prosthetic heart valve <NUM> shown in <FIG>. <FIG> is an illustration of the prosthetic heart valve <NUM> shown secured in place within the native mitral valve <NUM>.

<FIG> and <FIG> show another embodiment of a selective occlusion device 22y mounted in a native mitral valve <NUM>, as viewed in cross section. This embodiment includes a flexible membrane 44c with an open end facing the left ventricle <NUM>, as in other embodiments, and receiving blood flow from below when the heart cycle is in systole (<FIG>). In this portion of the heart cycle, the flexible membrane 44c expands against the native leaflets 16a, 16b to reduce regurgitation as previously discussed. In diastole, the flexible membrane collapses and expels the blood therein (<FIG>). Blood then travels in the reverse direction, generally, through the mitral valve <NUM> by flowing between the native leaflets 16a, 16b and outer surfaces of the collapsed membrane 44c. A difference between this embodiment and others is that multiple clip structures <NUM> are used to secure the selective occlusion device 22y directly to the leaflets 16a, 16b. The leaflets 16a, 16b are not clipped to each other. It will be appreciated that even further clip structures <NUM> may be used in this embodiment as well as others. In this embodiment, a clip structure <NUM> secures one side of the flexible membrane 44c to the anterior leaflet 16a and another clip structure <NUM> secures the flexible membrane 44c to the posterior leaflet 16b.

Claim 1:
Apparatus for treating blood flow regurgitation through a native heart valve including first and second native leaflets, the apparatus comprising:
a selective occlusion device (<NUM>, 22a) sized and configured to be implanted in the native heart valve and selectively operating with at least one of the first or second native leaflets to allow blood flow through the native heart valve when the heart cycle is in diastole and reduce blood flow regurgitation through the native heart valve when the heart cycle is in systole,
a clip structure (<NUM>) coupled with the selective occlusion device (<NUM>, 22a), the clip structure (<NUM>) configured to be affixed to a margin of at least one of the first or second native leaflets to secure the selective occlusion device (<NUM>, 22a) to the native heart valve.
wherein the selective occlusion device (<NUM>, 22a) comprises a prosthetic heart valve including a movable valve element configured to selectively control blood flow through the native heart valve and wherein the movable valve element comprises a flexible membrane (<NUM>) configured to engage the first and second native leaflets of the native heart valve when the heart cycle is in systole and disengage the first and second native leaflets when the heart cycle is in diastole.