Patent Description:
The present disclosure generally relates to the field of medical devices and procedures.

The native heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) of the human heart aid in the circulation blood through the cardiovascular system. These heart valves can be damaged, and thus rendered less effective, by congenital malformations, inflammatory processes, infectious conditions, or disease. <CIT> describes devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues.

The invention relates to an implantable valve repair system for repairing a native valve of a patient as further defined by claim <NUM>.

The implantable valve repair system for repairing a native valve of a patient includes an implantable prosthetic device and a connector. The implantable prosthetic device is configured to attach to two leaflets of the native valve of the patient. The connector is separate from the implantable prosthetic device and is also configured to attach to the two leaflets of the native valve of the patient. The implantable prosthetic device is configured both to allow the implantable prosthetic device to remain attached to the native valve after the connector is attached to the native valve and to allow the implantable prosthetic device to be removed from the native valve after the connector is attached to the native valve.

In some implementations, the present disclosure relates to a heart valve repair system comprising an implantable prosthetic device configured to attach to at least two leaflets of a native heart valve of a patient and hold the at least two leaflets in a relatively fixed position, and a connector that is separate from the implantable prosthetic device, the connector including first and second tissue anchors and being configured to be attached to the at least two leaflets of the native valve of the patient when the at least two leaflets are held by the implantable prosthetic device in the relatively fixed position, the implantable prosthetic device being configured to be detached from the at least two leaflets and removed from the patient with the connector remaining attached to the at least two leaflets.

The implantable prosthetic device may include a plurality of paddles that each comprise an inner paddle portion and an outer paddle portion. In some embodiments, the implantable prosthetic device includes a coaption element. For example, the paddles can be connected to a distal end of the coaption element. The prosthetic device and the connector can be configured to close a gap in the native valve of the patient when the valve repair system is attached to the native valve. The connector can be configured to keep the gap in the native valve of the patient closed after the prosthetic device is removed.

The heart valve repair system can further comprise one or more additional connectors. The connector can comprise a first anchor configured to be positioned on a ventricular side of a first leaflet of the at least two leaflets, a second anchor configured to be positioned on a ventricular side of a second leaflet of the at least two leaflets, and a connecting portion including one or more suture lines coupled to the first and second anchors and configured to extend through the first leaflet and the second leaflet.

In some embodiments, the connecting portion comprises a first suture line extending from the first anchor through the first leaflet, a second suture line extending from the second anchor through the second leaflet, and a suture-locking device engaging both the first suture line and the second suture line to hold the first leaflet and the second leaflet together. For example, the suture-locking device can include a wedge and a locking nut. In some embodiments, nut is configured to threadably engage the wedge to capture the first suture line and the second suture line within the wedge. The wedge can include a first engagement surface configured to engage a first leaflet of the at least two leaflets and a second engagement surface configured to engage a second leaflet of the at least two leaflets.

In some embodiments, the connector comprises a shape-memory alloy. In some embodiments, the connector is one of a pledgeted suture or a staple. In some embodiments, the implantable prosthetic device includes a first anchor configured to embed into a first valve leaflet and a second anchor configured to embed into a second valve leaflet.

In some implementations, the present disclosure relates to a valve repair system comprising an implantable prosthetic device comprising a first and second paddles that are movable between an open position and a closed position, and a first and second tissue-gripping elements associated with the first and second paddles, respectively, each of the first and second tissue-gripping elements being configured to attach to a respective leaflet of a native heart valve of a patient. The valve repair system further comprises a connector configured to be implanted in first and second leaflets of the native heart valve of the patient when the implantable prosthetic device is gripped to the first and second leaflets and to allow for the implantable prosthetic device to be removed when the connector is implanted in the first and second leaflets, the connector comprising a first anchor configured to engage a first valve leaflet of the native heart valve of the patient, a second anchor configured to engage a second valve leaflet of the native heart valve of the patient, and a connecting portion attached to and extending between the first anchor and the second anchor.

Each of the first and second paddles can comprise an inner paddle portion and an outer paddle portion. In some embodiments, the implantable prosthetic device includes a coaption element. The connector can be configured to keep a gap in the native valve of the patient closed after the prosthetic device is removed. The valve repair system can further comprise two or more additional connectors. The connector can include one or more suture lines.

The connector may include a wedge and a locking nut, the locking nut configured to be attached to the wedge to capture a first suture and a second suture within the wedge. For example, the wedge can include a first engagement surface configured to engage the first valve leaflet and a second engagement surface configured to engage the second valve leaflet. The connector can be one of a pledgeted suture or a staple. In some embodiments, the first anchor is configured to embed into the first valve leaflet and the second anchor is configured to embed into the second valve leaflet.

In some implementations, the present disclosure relates to a method of repairing a heart valve. The method comprises implanting a leaflet-securing implant on first and second leaflets of a native heart valve of a patient, the leaflet-securing implant including two or more leaflet-engagement features configured to hold respective portions of the first and second leaflets in a relatively fixed position. The method further comprises, while the leaflet-securing implant is engaged with the first and second leaflets, implanting an edge-to-edge connector device in the native heart valve of the patient at least in part by engaging a first tissue anchor of the edge-to-edge connector device with the first leaflet and engaging a second tissue anchor of the edge-to-edge connector device with the second leaflet, the second tissue anchor being coupled to the first tissue anchor via one or more connecting sutures. The method further comprises, after implanting the edge-to-edge connector device in the native heart valve, decoupling the leaflet-securing implant from the first and second leaflets, withdrawing the leaflet-securing implant from the heart of the patient, and maintaining the edge-to-edge connector device implanted in the native heart valve.

The leaflet-securing implant can include a spacer configured to occupy at least a portion of a space between respective edges of the first and second leaflets of the native heart valve when the leaflet-securing implant is engaged with the first and second leaflets. In some embodiments, the method further comprises, while the leaflet-securing implant is engaged with the first and second leaflets, implanting one or more additional edge-to-edge connector devices in the native heart valve of the patient. In some embodiments, the first tissue anchor is a first end of a staple device, the second tissue anchor is a second end of the staple device opposite the first end, and the one or more connecting sutures are an intermediate portion of the staple device between the first end and the second end.

A further understanding of the nature and advantages of the present invention are set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals.

To further clarify various aspects of embodiments of the present disclosure, a more particular description of the certain embodiments will be made by reference to various aspects of the appended drawings. It is appreciated that these drawings depict only typical embodiments of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, while the figures can be drawn to scale for some embodiments, the figures are not necessarily drawn to scale for all embodiments. Embodiments and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:.

The following description refers to the accompanying drawings, which illustrate specific embodiments of the present disclosure. Other embodiments having different structures and operation do not depart from the scope of the present disclosure.

Exemplary embodiments of the present disclosure are directed to systems and methods for repairing a defective heart valve. It should be noted that various embodiments of native valve reparation devices and systems for delivery thereof are disclosed herein, and any combination of these options/features can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible.

As described herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection may be direct as between the components or may be indirect such as through the use of one or more intermediary components. Also as described herein, reference to a "member," "component," or "portion" shall not be limited to a single structural member, component, or element but can include an assembly of components, members, or elements. Also as described herein, the terms "substantially" and "about" are defined as at least close to (and includes) a given value or state (preferably within <NUM>% of, more preferably within <NUM>% of, and most preferably within <NUM>% of).

The native heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves can be damaged, and thus rendered less effective, by congenital malformations, inflammatory processes, infectious conditions, or disease. Such damage to the valves can result in serious cardiovascular compromise or death. For many years, the definitive treatment for such damaged valves was surgical repair or replacement of the valve during open heart surgery. However, open-heart surgeries are highly invasive and are prone to many complications. Therefore, elderly and frail patients with defective heart valves may not be suitable candidates for open-heart operations. As an alternative, transvascular cardiac operations can be implemented for introducing and implanting prosthetic devices in a manner that is generally much less invasive than open heart surgery. One particular transvascular technique that can be used for accessing the native mitral and aortic valves is the trans-septal technique. The transseptal technique can involve inserting a catheter into the right femoral vein, up the inferior vena cava and into the right atrium. The septum is then punctured and the catheter passed into the left atrium. Access to the right atrium can be made via other blood vessels or access points. Furthermore, access to the aortic, tricuspid, mitral, or pulmonary valves in connection with any of the embodiments of the present disclosure can be made using a trans-aortic or trans-apical approach as well.

As described in greater detail below in connection with the description of <FIG>, a healthy human heart has a generally conical shape that tapers to a lower apex. The heart is four-chambered and comprises the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall generally referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve generally has a different anatomy than other native heart valves. The mitral valve includes an annulus portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice, and a pair of cusps, or leaflets, extending downward from the annulus into the left ventricle. The mitral valve annulus can generally form a "D"-shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes. The anterior leaflet can be larger than the posterior leaflet in some patients, forming a generally "C"-shaped coaptation boundary between the abutting edges of the leaflets when they are closed together.

When operating properly, the anterior leaflet and the posterior leaflet function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also referred to as "ventricular diastole" or "diastole"), the oxygenated blood that is collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also referred to as "ventricular systole" or "systole"), the increased blood pressure in the left ventricle urges the edges of the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back to the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward/into the left atrium, a plurality of fibrous cords called chordae tendineae tether the leaflets to papillary muscles in the left ventricle.

Mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows into the left atrium from the left ventricle during the systolic phase of heart contraction. Mitral regurgitation is a common form of valvular heart disease. Mitral regurgitation can have different causes, including leaflet prolapse, dysfunctional papillary muscles, or stretching or deformation of the mitral valve annulus resulting from, for example, dilation of the left ventricle. Mitral regurgitation at a central portion of the leaflets can be referred to as central jet mitral regurgitation, whereas mitral regurgitation nearer to one commissure (i.e., location where the leaflets meet) of the leaflets can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle and thus the valve does not close properly, allowing regurgitation to present.

Some solutions for treating mitral regurgitation in patients involve surgically stitching the edges of the native mitral valve leaflets directly to one another at or near a central portion of the leaflet edges, which may be referred to as an Alfieri procedure. Some solutions involve using a catheter delivery system to deliver a clip device to attempt to clip the edges of the leaflets together. However, the use of such clip devices can be associated with certain shortcomings when used to clip the middle of the leaflets where they overlap by about <NUM> or more. Furthermore, the use of multiple clips on the commissures of the mitral valve, where there may be more overlap of the leaflets, can result in a longer operation time and also joins the patient's leaflets at the sides, restricting blood flow. Additionally, both the surgical and clip treatments can create undesirable stress on patient leaflets.

To provide further context for the inventive solutions disclosed herein, further details of the human cardiac anatomy are disclosed below with reference to <FIG>. <FIG> and <FIG> are cutaway views of the human heart H in diastolic and systolic phases, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and mitral valve MV; i.e., the atrioventricular valves. Additionally, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets <NUM>, <NUM> shown in <FIG>) extending inward across the respective orifices that come together or "coapt" in the flowstream to form the one-way, fluid-occluding surfaces. The native valve repair systems of the present application are described primarily with respect to the mitral valve MV. Therefore, anatomical structures of the left atrium LA and left ventricle LV will be explained in greater detail. It should be understood that the devices described herein may also be used in repairing other native valves, e.g., the devices can be used in repairing the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase, or diastole, seen in <FIG>, the blood that was previously collected in the left atrium LA (during the systolic phase) moves through the mitral valve MV and into the left ventricle LV by expansion of the left ventricle LV. In the systolic phase, or systole, seen in <FIG>, the left ventricle LV contracts to force the blood through the aortic valve AV and ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close to prevent the blood from regurgitating from the left ventricle LV and back into the left atrium LA, and blood is collected in the left atrium from the pulmonary vein. In one exemplary embodiment, the systems and devices described by the present application are used to repair the function of a defective mitral valve MV. That is, the systems and devices are configured to help close the leaflets of the mitral valve to prevent blood from regurgitating from the left ventricle LV and back into the left atrium LA.

Referring now to <FIG>, the mitral valve MV includes two leaflets, the anterior leaflet <NUM> and the posterior leaflet <NUM>. The mitral valve MV also includes an annulus <NUM>, which is a variably dense fibrous ring of tissues that encircles the leaflets <NUM>, <NUM>. Referring to <FIG>, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae <NUM>. The chordae tendineae <NUM> are cord-like tendons that connect the papillary muscles <NUM> (i.e., the muscles located at the base of the chordae tendineae and within the walls of the left ventricle) to the leaflets <NUM>, <NUM> of the mitral valve MV. The papillary muscles <NUM> serve to limit the movements of the mitral valve MV and prevent the mitral valve from being reverted. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles do not open or close the mitral valve MV. Rather, the papillary muscles brace the mitral valve MV against the high pressure needed to circulate blood throughout the body. Together the papillary muscles and the chordae tendineae are known as the subvalvular apparatus, which functions to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes.

Various disease processes can impair proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's Disease, fibroelastic deficiency), inflammatory processes (e.g., Rheumatic Heart Disease), and infectious processes (e.g., endocarditis). In addition, damage to the left ventricle LV or the right ventricle RV from prior heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy) can distort a native valve's geometry, which can cause the native valve to dysfunction. However, the vast majority of patients undergoing valve surgery, such as surgery to the mitral valve MV, suffer from a degenerative disease that causes a malfunction in a leaflet (e.g., leaflets <NUM>, <NUM>) of a native valve (e.g., the mitral valve MV), which results in prolapse and regurgitation.

Generally, a native valve may malfunction in two different ways: (<NUM>) valve stenosis; and (<NUM>) valve regurgitation. Valve stenosis occurs when a native valve does not open completely and thereby causes an obstruction of blood flow. Typically, valve stenosis results from buildup of calcified material on the leaflets of a valve, which causes the leaflets to thicken and impairs the ability of the valve to fully open to permit forward blood flow.

The second type of valve malfunction, valve regurgitation, occurs when the leaflets of the valve do not close completely thereby causing blood to leak back into the prior chamber (e.g., causing blood to leak from the left ventricle to the left atrium). There are three mechanisms by which a native valve becomes regurgitant-or incompetent-which include Carpentier's type I, type II, and type III malfunctions. A Carpentier type I malfunction involves the dilation of the annulus such that normally functioning leaflets are distracted from each other and fail to form a tight seal (i.e., the leaflets do not coapt properly). Included in a type I mechanism malfunction are perforations of the leaflets, as are present in endocarditis. A Carpentier's type II malfunction involves prolapse of one or more leaflets of a native valve above a plane of coaption. A Carpentier's type III malfunction involves restriction of the motion of one or more leaflets of a native valve such that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or dilation of a ventricle (IIIb).

Referring to <FIG>, when a healthy mitral valve MV is in a closed position, the anterior leaflet <NUM> and the posterior leaflet <NUM> coapt, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Referring to <FIG>, regurgitation occurs when the anterior leaflet <NUM> or the posterior leaflet <NUM> of the mitral valve MV is displaced into the left atrium LA during systole. This failure to coapt causes a gap <NUM> between the anterior leaflet <NUM> and the posterior leaflet <NUM>, which allows blood to flow back into the left atrium LA from the left ventricle LV during systole. As set forth above, there are several different ways that a leaflet (e.g. leaflets <NUM>, <NUM> of mitral valve MV) may malfunction, which can thereby lead to regurgitation.

Referring to <FIG>, in certain situations, the mitral valve MV of a patient can have a wide gap <NUM> between the anterior leaflet <NUM> and the posterior leaflet <NUM> when the mitral valve is in a closed position (i.e., during the systolic phase). For example, the gap <NUM> can have a width W between about <NUM> and about <NUM>, such as between about <NUM> and about <NUM>, such as between about <NUM> and about <NUM>, such as about <NUM>. In some situations, the gap <NUM> can have a width W greater than <NUM>. In any of the above-mentioned situations, a valve repair system is desired that is capable of engaging the anterior leaflet <NUM> and the posterior leaflet <NUM> to close the gap <NUM> and prevent regurgitation of blood through the mitral valve MV.

Although stenosis or regurgitation can affect any valve, stenosis is predominantly found to affect either the aortic valve AV or the pulmonary valve PV, and regurgitation is predominantly found to affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the workload of the heart H and may lead to very serious conditions if left un-treated; such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) is primarily responsible for circulating the flow of blood throughout the body, malfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life threatening. Accordingly, because of the substantially higher pressures on the left side of the heart, dysfunction of the mitral valve MV or the aortic valve AV is much more problematic.

Malfunctioning native heart valves may either be repaired or replaced. Repair typically involves the preservation and correction of the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Because stenotic damage sustained by the leaflets is irreversible, the most conventional treatments for a stenotic aortic valve or stenotic pulmonary valve are removal and replacement of the valve with a surgically implanted heart valve, or displacement of the valve with a transcatheter heart valve. The mitral valve MV and the tricuspid valve TV are more prone to deformation of leaflets, which, as described above, prevents the mitral valve or tricuspid valve from closing properly and allows for regurgitation or back flow of blood from the ventricle into the atrium (e.g., a deformed mitral valve MV may allow for regurgitation or back flow from the left ventricle LV to the left atrium LA). The regurgitation or back flow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or the tricuspid valve TV are often repairable. In addition, regurgitation can occur due to the chordae tendineae <NUM> becoming dysfunctional (e.g., the chordae tendineae may stretch or rupture), which allows the anterior leaflet <NUM> and the posterior leaflet <NUM> to be reverted such that blood is regurgitated into the left atrium LA. The problems occurring due to dysfunctional chordae tendineae <NUM> can be repaired by repairing the chordae tendineae or the structure of the mitral valve (e.g., by securing the leaflets <NUM>, <NUM> at the affected portion of the mitral valve).

The systems and procedures disclosed herein refer to repairing the structure of a mitral valve. However, it should be understood that the systems, devices, and concepts provided herein can be used to repair any native valve, as well as any component of a native valve. Referring now to <FIG>, any of the devices and concepts provided herein can be used to repair the tricuspid valve TV. For example, any of the systems, devices, methods, and concepts provided herein can be used between any two of the anterior leaflet <NUM>, septal leaflet <NUM>, and posterior leaflet <NUM> of the tricuspid valve TV to prevent regurgitation of blood from the right ventricle into the right atrium. In addition, any of the systems, devices, methods, and concepts provided herein can be used on all three of the leaflets <NUM>, <NUM>, <NUM> together to prevent regurgitation of blood from the right ventricle to the right atrium. That is, the valve repair systems provided herein can be centrally located between the three leaflets <NUM>, <NUM>, <NUM>.

Some embodiments of systems for repairing a mitral or tricuspid valve in accordance with the present disclosure include a connector or an implantable prosthetic device. The connector and implantable prosthetic device can take a wide variety of different forms. For example, the implantable prosthetic device can be any device which holds a portion of the valve leaflets while the connector is implanted and that can be either removed (leaving the connector installed/implanted on the valve leaflets) or left installed/implanted on the native valve leaflets with the connector. For example, in some embodiments, an implantable prosthetic device can have an optional coaption element and at least one anchor for permanently or temporarily attaching to a valve leaflet. The optional coaption element can be configured to be positioned or disposed within the native heart valve orifice to at least partially fill the space between the valve leaflets or to form a more effective seal, thereby reducing or preventing regurgitation. The coaption element can be reduced in size or eliminated or omitted in certain embodiments disclosed herein, wherein the implantable prosthetic device may be removed after the connector is implanted. When included, the coaption element can have a structure that is impervious to blood and that allows the native leaflets to close around at least a portion of the coaption element during ventricular systole to block at least an amount of blood from flowing from the left or right ventricle back into the left or right atrium, respectively. The prosthetic device can be configured to seal against two or three native valve leaflets; that is, the device may be used in the native mitral (bicuspid) or tricuspid valves. The coaption element is sometimes referred to herein as a "spacer" because the coaption element can fill a space between improperly functioning native mitral or tricuspid leaflets that do not close/coapt completely.

The optional coaption element can have various shapes. In some embodiments, the coaption element can have an elongated cylindrical shape having an at least partially round cross-sectional shape. In some embodiments, the coaption element can have an oval cross-sectional shape, a crescent cross-sectional shape, or various other non-cylindrical shapes. When the prosthetic device is attached to the native valve leaflets, the coaption element can include an atrial portion positioned in or adjacent to the left atrium, a ventricular or lower portion positioned in or adjacent to the left ventricle, and a side surface that extends between the native mitral leaflets. In embodiments configured for use in the tricuspid valve, the atrial or upper portion can be positioned in or adjacent to the right atrium and the ventricular or lower portion can be positioned in or adjacent to the right ventricle, wherein the side surface extends between the native tricuspid leaflets.

The anchor component(s) of the prosthetic device can be configured to secure the device to one or both of the native mitral leaflets such that the coaption element is positioned between the two native leaflets. In embodiments configured for use in the tricuspid valve, the anchor can be configured to secure the device to one, two, or three of the tricuspid leaflets, such that the coaption element is positioned between two or three of the native leaflets. In some embodiments, the anchor can attach to the coaption element at a location adjacent to or associated with the ventricular portion of the coaption element. In some embodiments, the anchor can be coupled/attached to a shaft or actuation wire, to which the coaption element is also attached. In some embodiments, the anchor and the coaption element can be positioned independently with respect to each other by separately moving each of the anchor and the coaption element along the longitudinal axis of the shaft or actuation wire. In some embodiments, the anchor and the coaption element can be positioned simultaneously by moving the anchor and the coaption element together along the longitudinal axis of the shaft or actuation wire. The anchor can be configured to be positioned behind, at least in part, a native leaflet when implanted such that the leaflet is grasped by the anchor or pinned or captured between the anchor and the coaptation element.

The prosthetic device can be configured to be implanted via a delivery sheath/catheter. The optional coaption element and the anchor can be compressible to a radially compressed state and can be self-expandable to a radially expanded state when compressive pressure is released or when the various components are manually expanded. The prosthetic device can be configured for the anchor to be expanded radially away from the still-compressed coaption element initially in order to create a gap between the coaption element and the anchor. A native leaflet can then be positioned in the gap. The coaption element can be expanded radially, closing the gap between the coaption element and the anchor and capturing the leaflet between the coaption element and the anchor. In some embodiments, the anchor and coaption element are configured to self-expand. The implantation methods for various embodiments can be different and are more fully discussed below with respect to each embodiment. Additional information regarding these and other delivery methods can be found in <CIT> and <CIT><CIT>, <CIT>.

<CIT>, entitled Heart Valve Sealing Devices and Delivery Devices Therefor, discloses an exemplary implantable prosthetic device.

The disclosed prosthetic devices can be configured such that the anchor component is connected to one or more leaflets, thereby taking advantage of the tension from native chordae tendineae to resist high systolic pressure urging the device toward the left atrium. During diastole, the devices can rely on the compressive and retention forces exerted on the leaflet that is grasped by the anchor(s).

Deployable and releasable prosthetic devices, including but not limited to the disclosed deployable and releasable prosthetic devices, can be configured as part of a valve repair system that is used in conjunction with one or more connectors (e.g., sutures) that connect the leaflets of the heart valve together. The connectors can be configured in a variety of ways. For example, each of the one or more connectors may be a suture, a staple, a stitch/suture, or other suitable connector. The connectors may be separate from, or connected but separable from, the prosthetic device. The disclosed prosthetic device may be configured to grasp one or more leaflets of the heart valve to hold the heart valve (or portions of the heart valve, such as leaflets) in a position while the one or more connectors are being attached to the leaflets. Once the one or more connectors are in place and connecting the leaflets of the heart valve together, the implantable prosthetic device may be kept in position and used in combination with the one or more connectors, or the implantable prosthetic device may be released and removed from the heart while the connectors remain in position.

The terms "suture" and "stitch" are used herein according to their broad/plain and ordinary meaning and may refer to any elongate cord strip, strand, line, rope, wire, filament, tie, string, ribbon, strap, or portion thereof, or other type/form of material used in medical procedures (e.g., ePTFE suture, for example, GORE-TEX® sutures, W. Gore, Newark, Delaware). Furthermore, embodiments of the present disclosure may be implemented in connection with non-surgical or non-biological suture or stich implantation. With respect to the present disclosure, one having ordinary skill in the art will understand that a wire, staple, or other similar material may be used in place of a suture/stitch. Furthermore, in some contexts herein, the terms "stitch" and "suture" may be used substantially interchangeably. In addition, use of the singular form of any of the suture-related terms listed above, including the terms "suture" and "stitch," may be used to refer to a single suture/cord, or to a portion thereof. Furthermore, sutures/stitches may be used with a pledget to reduce tissue damage or spread the suture or stitch load over a broader surface area.

The implantation methods for various embodiments of the disclosed prosthetic devices and the configuration of the disclosed prosthetic devices can be adapted to both allow for deployment and, in some cases, release of the prosthetic devices as well as the deployment and attachment of the one or more connectors to the leaflets of the heart valve after deployment of the prosthetic devices.

Referring now to <FIG>, an exemplary embodiment of an implantable prosthetic device <NUM> is shown being delivered and implanted within the native mitral valve MV of the heart H. As with the implantable device disclosed in detail in <CIT>, the implantable prosthetic device <NUM> may be deployed from a delivery sheath or means for delivery <NUM> and optionally includes a coaption portion <NUM> and an anchor portion <NUM>. The coaption portion/element is optional or may be minimized in size in the present application, since the prosthetic device may be removed, and thus the coaptation portion would not serve to improve leaflet coaptation postoperatively and the utility thereof is reduced compared to implementations in which the prosthetic device remains implanted in the patient post-operatively. The coaption portion <NUM> of the implantable prosthetic device <NUM> includes a coaption element or means for coapting <NUM> that is adapted to be implanted between the leaflets of the native mitral valve and may be slidably attached to an actuation wire or shaft <NUM> during one or more periods of the process.

The prosthetic device <NUM> may be considered a leaflet-securing implant due to its ability to clamp, grip, hold, clip, pinch, or otherwise secure portions of two or more leaflets thereto, thereby maintaining a fixed relative position of such leaflet portions. The device <NUM> may be a clip device or may include a central spacer element or portion in some embodiments, while other embodiments may omit such features. The prosthetic device <NUM> may further be considered an edge-to-edge repair device in that it is configured to attach to or between the edges of the target valve leaflets or repair or compensate for a gap that may undesirably form or exist between the edges of the native valve leaflets.

In some embodiments, the overall shape of the coaption element or means for coapting <NUM> is an elliptical or oval cross section when seen from the surgeon's view (top view), a tapered shape or cross section when seen from an LVOT view (side view), and a substantially round shape or rounded shape when seen from an intra-commissural view. In some embodiments, a blend of these three geometries can result in the three-dimensional shape of the illustrated coaption element or means for coapting <NUM>.

The anchor portion <NUM> can be actuatable between open and closed conditions/configurations and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation wire or means for actuating <NUM> can open or close the anchor portion <NUM> of the implantable prosthetic device <NUM> to grasp the mitral valve leaflets during implantation.

Referring to <FIG>, in the illustrated embodiment, the anchor portion <NUM> of the implantable prosthetic device <NUM> includes outer paddles <NUM> and inner paddles <NUM> that may be connected between a cap <NUM> and the distal end of the coaption element or means for coapting <NUM>. The anchor portion <NUM> further includes attachment portions or gripping members. The illustrated gripping members can comprise barbed clasps <NUM> that can be opened separately by pulling on an attached actuation line <NUM> that extends through the delivery sheath or means for delivery <NUM> to the barbed clasp <NUM>.

The coaption element or means for coapting <NUM> and paddles <NUM>, <NUM> can be formed from a flexible material that may be a metal fabric, such as a mesh, woven, braided, or formed in any other suitable way or a laser cut or otherwise cut flexible material. The flexible material may be cloth, shape-memory alloy wire-such as Nitinol-to provide shape-setting capability, or any other flexible material suitable for implantation in the human body.

Referring now to <FIG>, the delivery sheath or means for delivery <NUM> (e.g., catheter delivery system) is inserted into the left atrium LA, for example, through the septum, and the implantable prosthetic device <NUM> is deployed from the delivery sheath or means for delivery <NUM> in an open (e.g., fully open) condition/configuration. The actuation wire or means for actuating <NUM> can then be retracted to move the implantable prosthetic device <NUM> into an at least partially closed (e.g., fully closed) condition/configuration, as shown in <FIG>.

As can be seen in <FIG>, the implantable prosthetic device <NUM> can be moved into a position at least partially within the mitral valve MV, into the ventricle LV, and at least partially opened so that the leaflets <NUM>, <NUM> can be grasped. Referring now to <FIG>, an actuation line <NUM> can be extended to close one of the clasps <NUM>, capturing the valve leaflet <NUM>. <FIG> shows another actuation line <NUM> being extended to close the other clasp <NUM>, capturing the remaining leaflet <NUM>. As can be seen in <FIG>, one or more of the delivery sheath or means for delivery <NUM>, the actuation wire or means for actuating <NUM>, and the actuation line(s) <NUM> can then be retracted, in some implementations, and the implantable prosthetic device <NUM> can be left in place fully closed and deployed in the native mitral valve MV.

As shown in <FIG>, the implantable prosthetic device <NUM> can facilitate one or more connectors (e.g., sutures) <NUM> being deployed and implanted to connect the two valve leaflets <NUM>, <NUM> together while the implantable prosthetic device <NUM> is in place. The one or more connectors <NUM> can be attached to the leaflets <NUM>, <NUM> and left in place along with the fully closed and implantable prosthetic device <NUM> or the one or more connectors <NUM> can be attached to the leaflets <NUM>, <NUM> and left in place and the implantable prosthetic device <NUM> can be released and removed along with the delivery sheath or means for delivery <NUM>, the actuation wire or means for actuating <NUM>, or the actuation line(s) <NUM>. The connector <NUM> can be considered an edge-to-edge valve repair device because it is configured to be coupled to or approximate the edges of two or more leaflets to one another to thereby reduce a gap that may otherwise present/exist between the edges of the native valve leaflets.

Referring to <FIG>, in the illustrated embodiment, the clasps <NUM> on the implantable prosthetic device <NUM> have been closed to capture the valve leaflets <NUM>, <NUM>, respectively, while the delivery sheath or means for delivery <NUM> or the actuation wire or means for actuating <NUM> have not been retracted. In some implementations, a secondary delivery sheath or secondary means for deliver (e.g., catheter delivery system) <NUM> may have been deployed through the delivery sheath or means for delivery <NUM> to deploy the one or more connectors <NUM>. In some embodiments, the secondary delivery sheath or secondary means for delivery <NUM> includes an open distal end <NUM> and may be steerable such that the distal end <NUM> can be positioned as desired, such as adjacent a valve leaflet <NUM>, <NUM> as shown in <FIG>.

The one or more connectors <NUM> can be deployed through the secondary delivery sheath or secondary means for delivery <NUM> (or through any other delivery system or mechanism). The one or more connectors <NUM> can be configured in a variety of ways. Any suitable connector or connecting means <NUM> capable of being deployed through a delivery sheath or a catheter and able to connect the valve leaflets <NUM>, <NUM> together may be used. For example, the connector or connecting means <NUM> may be a suture, a pledgeted suture, a staple, a stitch, a wire, or other suitable connecting device.

As best illustrated in <FIG>, in the illustrated embodiment, the connector <NUM> includes a first tissue anchor <NUM> positioned on the ventricular side of the second valve leaflet <NUM> and a second tissue anchor <NUM> positioned on the ventricular side of the first valve leaflet <NUM>. The first anchor <NUM> and the second anchor <NUM> are connected to each other, through the leaflets <NUM>, <NUM>, by a connecting portion. In the illustrated embodiment, the connecting portion is a suture line <NUM>.

Referring to <FIG>, with the distal end <NUM> of the secondary delivery sheath or secondary means for delivery <NUM> positioned adjacent the atrial side of the second valve leaflet <NUM>, the second valve leaflet <NUM> may be pierced to create an opening (not shown) therein. The second valve leaflet <NUM> may be pierced in any of a variety of ways. For example, a piercing device (not shown), such as a needle or other pointed-tip or sharp-edged device may be delivered through the secondary delivery sheath or secondary means for delivery <NUM> to the distal end <NUM> and extended or pushed through the second valve leaflet <NUM>. Alternatively, the distal end <NUM> of the secondary delivery sheath or secondary means for delivery <NUM> may be adapted to pierce the valve leaflet <NUM>. For example, the distal end <NUM> of the delivery sheath may be sharp or pointed, like a needle, but may also include a lumen for delivering the catheter.

Once the second valve leaflet <NUM> has been pierced, the connector <NUM> may be delivered through the secondary delivery sheath or secondary means for delivery <NUM> to the distal end <NUM> and extended or pushed through the opening in the second valve leaflet <NUM>. In the illustrated embodiment, the first anchor <NUM> is attached to, or formed at, the end of the suture line <NUM>. The first anchor may be attached to, or formed at, the end of the suture line <NUM> while both the suture line <NUM> and the first anchor <NUM> are delivered through the secondary delivery sheath or secondary means for delivery <NUM>. In other embodiments, the first anchor <NUM> may be attached to, or formed in, the end of the suture line <NUM> after the suture line <NUM> is delivered through the secondary delivery sheath or secondary means for delivery <NUM>.

The first anchor <NUM> may be configured in a variety of ways. Any configuration that can be positioned adjacent the second valve leaflet <NUM> to secure the suture line <NUM> to the second valve leaflet <NUM> may be used. For example, the first anchor <NUM> can be a pledget, a knot formed in the suture line <NUM>, a stop, or other suture line anchoring device. The first anchor <NUM> may be collapsible/expandable such that within the secondary delivery sheath or secondary means for delivery <NUM>, the first anchor <NUM> is in a collapsed state. Once the first anchor <NUM> exits the distal end <NUM> of the secondary delivery sheath or secondary means for delivery <NUM>, the first anchor <NUM> may expand. In one exemplary embodiment, the first anchor <NUM> includes a shape-memory alloy wire-such as Nitinol-to provide shape-setting capability. In the collapsed state, the first anchor <NUM> may be received through the opening in the second valve leaflet <NUM>. In the expanded state, the first anchor <NUM> can have a shape and size that does not fit through the opening in the second valve leaflet <NUM>. Although described in certain contexts herein as comprising pledgets or other structures, the anchors <NUM>, <NUM> may be formed at least in part of bulky suture knots having a width dimension sufficient to prevent the knot/anchor from being drawn back through the opening in the leaflet. Such knot(s) can be formed from a unitary suture with the suture line <NUM>. The connector anchors <NUM>, <NUM> may be disposed between the clamps/anchors of the prosthetic device <NUM> and the respective leaflets prior to removal of the prosthetic device <NUM>.

Referring to <FIG> and <FIG>, once the connector <NUM> is installed onto the second valve leaflet <NUM>, the secondary delivery sheath or secondary means for delivery <NUM> may be steered such that the distal end <NUM> is positioned adjacent the atrial side of the first valve leaflet <NUM> and the suture line <NUM> extends between the leaflets <NUM>, <NUM>.

Once the distal end <NUM> is adjacent the atrial side of the first valve leaflet <NUM>, the first valve leaflet <NUM> may be pierced in the same manner as described regarding the second valve leaflet <NUM>. Once the first valve leaflet <NUM> has been pierced, the suture line <NUM> may be extended through the opening formed in the first valve leaflet <NUM> and the second anchor <NUM> may be attached to or formed in the suture line <NUM> adjacent the second valve leaflet <NUM> to secure the suture line <NUM> to the first valve leaflet <NUM>. The second anchor <NUM> can be substantially similar to the first anchor <NUM> and may be deployed or formed in the same manner as the first anchor <NUM>. In other embodiments, however, the first anchor <NUM> and the second anchor <NUM> may be different.

Referring to <FIG>, with the connector(s) <NUM> in place, the first anchor <NUM> and the second anchor <NUM> can be positioned against the ventricular side of the second valve leaflet <NUM> and first valve leaflet <NUM>, respectively. The suture line <NUM> extends from the first anchor <NUM> to the second anchor <NUM> through both of the valve leaflets <NUM>, <NUM>. In this way, the connector <NUM> can hold the valve leaflets <NUM>, <NUM> together in the area of the connector <NUM>. In some embodiments, the remaining suture line <NUM> extending from the second anchor <NUM> up through the secondary delivery sheath or secondary means for delivery <NUM> can be cut to detach the secondary delivery sheath or secondary means for delivery <NUM> from the connector <NUM> and the secondary delivery sheath or secondary means for delivery <NUM> can be withdrawn.

Referring to <FIG>, with the connector <NUM> in place, the implantable prosthetic device <NUM> can be kept in place and work in conjunction with the one or more connectors <NUM>, or, as illustrated, can be removed such that the one or more connectors <NUM> holds the valve leaflets together without the ongoing assistance of the implantable prosthetic device <NUM>.

To remove the implantable prosthetic device <NUM>, the actuation lines <NUM> can be retracted to open the clasps <NUM> and release each of the valve leaflet <NUM>, <NUM>. The actuation wire or means for actuating <NUM> can then be extended to move the implantable prosthetic device <NUM> into the fully open condition shown in <FIG> or another position that allows the prosthetic device <NUM> to be removed. The implantable prosthetic device <NUM> and the delivery sheath or means for delivery <NUM> are then retracted from the left atrium LA through the septum.

Referring to <FIG>, the atrial side of the mitral valve MV is shown with a plurality of connectors <NUM> installed. In particular, five separate connectors <NUM>, in the form of anchored sutures, extend from the first valve leaflet <NUM> to the second valve leaflet <NUM> to close the gap <NUM> and prevent regurgitation of blood through the mitral valve MV. In the illustrated embodiment, the five connectors <NUM> are evenly spaced from each other and parallel. In other embodiments, however, the number of connectors <NUM> can be greater than five or less than five and the connectors <NUM> may not be parallel to each other or evenly spaced.

Referring to <FIG>, another exemplary embodiment of a connector <NUM> is shown installed in the first valve leaflet <NUM> and second valve leaflet <NUM> of the mitral valve MV. The connector <NUM> may be configured in a variety of ways. In the illustrated embodiment, the connector <NUM> is formed as a staple or wire having a first end <NUM> connected to an opposite a second end <NUM> by an intermediate connecting portion <NUM>. The connecting portion <NUM> extends from the ventricular side of the first valve leaflet <NUM> through both the first valve leaflet <NUM> and the second valve leaflet <NUM> to the ventricular side of the second valve leaflet <NUM>. Thus, the connecting portion <NUM> serves to connect the first valve leaflet <NUM> and the second valve leaflet <NUM>.

The first end <NUM> and the second end <NUM> serve as anchors to attach or anchor the connector <NUM> to the first valve leaflet <NUM> and the second valve leaflet <NUM>. As shown in <FIG>, both the first end <NUM> and the second end <NUM> can be curved or curled downward toward the tips <NUM>, <NUM> of the first valve leaflet <NUM> and the second valve leaflet <NUM> (i.e. toward the left ventricle) and inward into the first valve leaflet <NUM> and the second valve leaflet <NUM>. Thus, the first end <NUM> and the second end <NUM> of the connector <NUM> may pierce into the first valve leaflet <NUM> and the second valve leaflet <NUM>, respectively, to secure the connector <NUM> to the leaflets <NUM>, <NUM>. In the illustrated embodiment, the first end <NUM> and the second end <NUM> of the connector <NUM> are imbedded into the first valve leaflet <NUM> and the second valve leaflet <NUM>, respectively.

The connector <NUM> may be made of any suitable material or materials. In one exemplary embodiment, the connector <NUM> is made from, or includes, a shape-memory alloy wire-such as Nitinol-to provide shape-setting capability. In a free state, the illustrated connector <NUM> has the shape illustrated in <FIG>. In other embodiments, however, the connector <NUM> may be shaped differently. Any shape that allows the connector <NUM> to anchor into and connect the leaflets <NUM>, <NUM> may be used.

The use of shape-memory alloy materials can allow the connector <NUM> to be delivered and deployed through, for example, the secondary delivery sheath or secondary means for delivery <NUM> discussed in relation to the embodiment of <FIG>. Thus, the connector <NUM>, within the secondary delivery sheath or secondary means for delivery <NUM>, may be in a generally elongated configuration. For example, the open distal end <NUM> of the secondary delivery sheath or secondary means for delivery <NUM> may be steered such that the distal end <NUM> is positioned adjacent the atrial side of the first valve leaflet <NUM>. A piercing device (not shown) may be delivered through the secondary delivery sheath or secondary means for delivery <NUM> to the distal end <NUM> and extended or pushed through the first valve leaflet <NUM> to create an opening in the first valve leaflet <NUM>. Alternatively, the first end <NUM> of the connector <NUM> or the distal end <NUM> may be configured as a piercing device and used to create an opening in the first valve leaflet <NUM>.

Once the first valve leaflet <NUM> has been pierced, the connector <NUM> may be delivered through the secondary delivery sheath or secondary means for delivery <NUM> to the distal end <NUM> and extended or pushed through the opening in the first valve leaflet <NUM>. Once the first end <NUM> of the connector <NUM> exits the distal end <NUM>, the shape-setting capability of the material of the connector <NUM> cause the first end <NUM> to revert to its free state. In the illustrated embodiment, the first end <NUM> curls downward and inward to embed into the ventricular side of the first valve leaflet <NUM>.

Once the connector <NUM> is installed onto the first valve leaflet <NUM>, the secondary delivery sheath or secondary means for delivery <NUM> may be steered such that the distal end <NUM> is positioned adjacent the atrial side of the second valve leaflet <NUM>. The second valve leaflet <NUM> may be pierced in the same manner as described regarding the first valve leaflet <NUM>.

Once the second valve leaflet <NUM> has been pierced, the second end <NUM> of the connector <NUM> may be delivered extended or pushed through the opening in the second valve leaflet <NUM>. Once the second end <NUM> of the connector <NUM> exits the distal end <NUM>, the shape-setting capability of the material of the connector <NUM> causes the second end <NUM> to revert to its free state. In the illustrated embodiment, the second end <NUM> curls downward and inward to embed into the ventricular side of the second valve leaflet <NUM>. Thus, the first end <NUM> is anchored in the first valve leaflet <NUM>, the second end <NUM> is anchored in the second valve leaflet <NUM>, and the connecting portion <NUM> connects the first valve leaflet <NUM> and the second valve leaflet <NUM>.

In the illustrated embodiment, the connecting portion <NUM> is slightly curved. In other embodiments, however, the connecting portion <NUM> can be any suitable shape, such as straight, less curvature, or more curvature.

It will be understood that, similar to the connectors <NUM> shown in <FIG>, more than one connector <NUM> may be used to extend from the first valve leaflet <NUM> to the second valve leaflet <NUM> to close the gap <NUM> and prevent regurgitation of blood through the mitral valve MV. Furthermore, the connector <NUM> may be implanted while a prosthetic leaflet-holding device, such as similar to the device <NUM> described above or other clip or clamp device, holds the leaflets together. That is, any of the connectors described in any of the embodiments in <FIG> may be deployed with a prosthetic leaflet-holding device in place to facilitate the placement of the connector(s). For clarity and convenience, suture-holding prosthetic devices are not shown in <FIG> allow for greater detail of illustration with respect to the respective connector(s) shown.

Referring to <FIG>, another exemplary embodiment of a connector <NUM> is shown installed in the first valve leaflet <NUM> and second valve leaflet <NUM> of the mitral valve MV. The connector <NUM> is substantially similar to the connector <NUM> in that it is formed as a staple or wire having a first end <NUM> connected to an opposite a second end <NUM> by a connecting portion <NUM>. The first end <NUM> and the second end <NUM> serve as anchors to attach or anchor the connector <NUM> to the first valve leaflet <NUM> and the second valve leaflet <NUM>, respectively. As with the connector <NUM>, the connector <NUM> may be formed from or include a shape-memory alloy wire-such as Nitinol-to provide shape-setting capability.

As shown in <FIG>, when installed however, the first end <NUM> and the second end <NUM> of connector <NUM> curve or curl upward toward the base of the first valve leaflet <NUM> and the second valve leaflet <NUM> (i.e. toward the left atrium) and inward into the first valve leaflet <NUM> and the second valve leaflet <NUM>. In addition, the connecting portion <NUM> does not extend through openings in the valve leaflets <NUM>, <NUM>. Instead, the connecting portion <NUM> extends around the tips <NUM>, <NUM> of the valve leaflets <NUM>, <NUM>, respectively.

During installation, instead of positioning the distal end <NUM> of the secondary delivery sheath or secondary means for delivery <NUM> adjacent the atrial side of the valve leaflets <NUM>, <NUM> in order to pierce the leaflets <NUM>, <NUM>, the distal end <NUM> is steered to the ventricular side of the valve leaflets <NUM>, <NUM>. In particular, the secondary delivery sheath or secondary means for delivery <NUM> may be extended into the left ventricle and steered such that the distal end <NUM> is adjacent the ventricular side of the first valve leaflet <NUM>. The connector <NUM> may be delivered through the secondary delivery sheath or secondary means for delivery <NUM> and out of the distal end <NUM>. Once the first end <NUM> of the connector <NUM> exits the distal end <NUM>, the shape-setting capability of the material of the connector <NUM> cause the first end <NUM> to revert to its free state. In the illustrated embodiment, the first end <NUM> curls upward and inward to embed into the ventricular side of the first valve leaflet <NUM>.

Once the connector <NUM> is installed onto the first valve leaflet <NUM>, the secondary delivery sheath or secondary means for delivery <NUM> may be steered such that the distal end <NUM> is positioned adjacent the ventricular side of the second valve leaflet <NUM> and the second end <NUM> of the connector <NUM> may be extended or pushed out of the distal end <NUM>. Once the second end <NUM> exits the distal end <NUM>, the shape-setting capability of the material of the connector <NUM> cause the second end <NUM> to revert to its free state. In the illustrated embodiment, the second end <NUM> curls upward and inward to embed into the ventricular side of the second valve leaflet <NUM>. Thus, the first end <NUM> is anchored in the first valve leaflet <NUM>, the second end <NUM> is anchored in the second valve leaflet <NUM>, and the connecting portion <NUM> extends around the valve leaflet tips <NUM>, <NUM> to connect the first valve leaflet <NUM> and the second valve leaflet <NUM>.

Referring to <FIG>, another exemplary embodiment of a connector <NUM> is shown installed in the first valve leaflet <NUM> and second valve leaflet <NUM> of the mitral valve MV. The connector <NUM> is similar to the connector <NUM> in that it is formed as a staple or wire having a first end <NUM> connected to an opposite a second end <NUM> by a connecting portion <NUM>. The first end <NUM> and the second end <NUM> serve as anchors to attach or anchor the connector <NUM> to the first valve leaflet <NUM> and the second valve leaflet <NUM>, respectively. As with the connector <NUM>, the connector <NUM> may be formed from or include a shape-memory alloy wire-such as Nitinol-to provide shape-setting capability. In the illustrated embodiment, the connector <NUM> has a continuous curled shape.

During installation, the open distal end <NUM> of the secondary delivery sheath or secondary means for delivery <NUM> may be steered such that the distal end <NUM> is positioned adjacent the atrial side of the second valve leaflet <NUM>. The first end <NUM> of the connector <NUM> may be configured as a piercing device and used to create an opening in the second valve leaflet <NUM>.

The connector <NUM> may be delivered through the secondary delivery sheath or secondary means for delivery <NUM> to the distal end <NUM> and extended or pushed into the first valve leaflet <NUM>. Once the first end <NUM> of the connector <NUM> exits the distal end <NUM>, the shape-setting capability of the material of the connector <NUM> cause the portion of the connector <NUM> deployed from the secondary delivery sheath or secondary means for delivery <NUM> to revert to its free state. In the illustrated embodiment, the first end <NUM> of the connector <NUM> follows the curved path shown by arrow A as the connector <NUM> deployed from the secondary delivery sheath or secondary means for delivery <NUM>. In particular, the first end <NUM> extends through the second valve leaflet <NUM> in a downward curved path before exiting the atrial side of the second valve leaflet <NUM> at a location closer to the tip <NUM> of the second valve leaflet <NUM> than the location where the first end <NUM> initially entered the second valve leaflet <NUM>. After exiting the atrial side of the second valve leaflet <NUM>, the first end enters the atrial side of the first valve leaflet <NUM> and extends in an upward curved path until the second end <NUM> exits the distal end <NUM> of the secondary delivery sheath or secondary means for delivery <NUM> (i.e., the connector <NUM> is fully installed).

In the illustrated embodiment, the connector <NUM> is not exposed on the ventricular sides of the first and second valve leaflets <NUM>, <NUM>. In other embodiments, however, as the first end <NUM> tunneled the curved path through the first and second valve leaflets <NUM>, <NUM>, the first end <NUM> may exit and reenter the ventricular sides of the first and second valve leaflets <NUM>, <NUM>. Thus, a portion of the embedded connector <NUM> may be exposed on the ventricular sides of the first and second valve leaflets <NUM>, <NUM>.

Referring to <FIG>, another exemplary embodiment of a connector <NUM> is shown being installed in the first valve leaflet <NUM> and second valve leaflet <NUM> of the mitral valve MV. The connector <NUM> is similar to the connector <NUM> of <FIG> in that the connector <NUM> includes a first anchor <NUM> positioned on the ventricular side of the second valve leaflet <NUM> for anchoring a suture line to the second valve leaflet <NUM> and a second anchor <NUM> positioned on the ventricular side of the first valve leaflet <NUM> for anchoring a suture line to the first valve leaflet <NUM>.

However, while the connector <NUM> has a suture line <NUM> that extends between the first anchor <NUM> and the second anchor <NUM>, the connector <NUM> has a first suture line <NUM> attached to the first anchor <NUM> and a separate, second suture line <NUM> attached to the second anchor <NUM>. The connector <NUM> also includes a suture-locking device <NUM> configured to capture first suture line <NUM> and second suture line <NUM> and lock them in position relative to the suture-locking device <NUM>.

The connector <NUM> can be delivered and deployed through, for example, one or more delivery sheathes or means for delivery in a similar manner as discussed in relation to the embodiment of <FIG>. The first anchor <NUM> and first suture line <NUM> may be deployed via the same delivery sheath or means for delivery as the second anchor <NUM> and second suture line <NUM> or may be deployed via a different delivery sheath or secondary means for delivery.

As shown in <FIG>, the second valve leaflet <NUM> may be pierced and the first anchor <NUM> may be positioned on the ventricular side of the second valve leaflet <NUM> with the first suture line <NUM> extending through the second valve leaflet <NUM>. Similarly, the first valve leaflet <NUM> may be pierced and the second anchor <NUM> may be positioned on the ventricular side of the first valve leaflet <NUM> with the second suture line <NUM> extending through the first valve leaflet <NUM>.

The suture-locking device <NUM> can be deployed via the delivery sheath or means for delivery <NUM>. The suture-locking device <NUM> may be mounted onto the first and second suture lines <NUM>, <NUM> such that the first and second suture lines <NUM>, <NUM> extend through the suture-locking device <NUM>. The suture-locking device <NUM> may be mounted onto the first and second suture lines <NUM>, <NUM> prior to the suture-locking device <NUM> being deployed via the delivery sheath or means for delivery <NUM> or in the left atrium, after the suture-locking device <NUM> exits the delivery sheath or means for delivery <NUM>.

The suture-locking device <NUM> may be configured in a variety of ways. Any device that can facilitate drawing the first and second valve leaflets <NUM>, <NUM> together and locking the first and second suture lines <NUM>, <NUM> in place in order to hold the first and second valve leaflets <NUM>, <NUM> together may be used. In the illustrated embodiment, the suture-locking device includes a wedge-type device <NUM> and a locking nut/clip <NUM>.

Referring to <FIG>, the wedge <NUM> includes a first angled engagement surface <NUM> having an channel (not shown) that receives the first suture line <NUM> and a second angled engagement surface <NUM>, opposite the first angled engagement surface <NUM>, having a second channel (not shown) that receives the second suture line <NUM>. The first angled engagement surface <NUM> and the second angled engagement surface <NUM> form the tapering wedge shape of the wedge <NUM> and are connected via a base surface <NUM>. The first suture line <NUM> and the second suture line <NUM> exit the wedge <NUM> via a locking aperture (not shown) in the base surface <NUM>.

The locking nut <NUM> is configured to, at least partially, be received in the locking aperture. The locking nut <NUM> is annular and includes an internal, longitudinal passage (not shown) through which the first suture line <NUM> and the second suture line <NUM> extend. The locking nut <NUM> can be configured to attach to the wedge <NUM> in a manner which locks the first suture line <NUM> and the second suture line <NUM> in place relative to the wedge <NUM>. In an exemplary embodiment, the locking nut <NUM> includes a male threaded portion (not shown) configured to threadably engage a corresponding female threaded portion (not shown) in the locking aperture of the wedge <NUM>. In some embodiments, the locking nut <NUM> comprises a clip or other form.

Referring to <FIG>, when the suture-locking device is positioned such that the first suture line <NUM> and the second suture line <NUM> are received through the wedge <NUM>, the first suture line <NUM> and the second suture line <NUM> can be pulled in the direction of the left ventricle LV as shown by arrows B in <FIG> and the wedge <NUM> can be pushed in the opposite direction as shown by arrow C. As a result, the first valve leaflet <NUM> and the second valve leaflet <NUM> are drawn together such that the wedge <NUM> is sandwiched between the first valve leaflet <NUM>, which engages the second angled engagement surface <NUM>, and the second valve leaflet <NUM>, which engages the second angled engagement surface <NUM>.

To lock the first valve leaflet <NUM> and the second valve leaflet <NUM> together, the locking nut <NUM> can be attached to the wedge <NUM> to capture the first suture line <NUM> and the second suture line <NUM> between the locking nut <NUM> and the wedge <NUM>. For example, the locking nut <NUM> can be threaded into the lacking aperture until the first suture line <NUM> and the second suture line <NUM> are sandwiched between the locking nut <NUM> and an interior surface of the wedge <NUM>.

Once the first suture line <NUM> and the second suture line <NUM> are captured between the locking nut <NUM> and the wedge <NUM>, the first suture line <NUM> and the second suture line <NUM> can be cut external to the locking nut <NUM>.

While various inventive aspects, concepts and features of the disclosures may be described and illustrated herein as embodied in combination in the exemplary embodiments, these various aspects, concepts, and features may be used in many alternative embodiments, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within the scope of the present application. Still further, while various alternative embodiments as to the various aspects, concepts, and features of the disclosures-such as alternative materials, structures, configurations, methods, devices, and components, alternatives as to form, fit, and function, and so on-may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether presently known or later developed. Those skilled in the art may readily adopt one or more of the inventive aspects, concepts, or features into additional embodiments and uses within the scope of the present application even if such embodiments are not expressly disclosed herein.

Additionally, even though some features, concepts, or aspects of the disclosures may be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Still further, exemplary or representative values and ranges may be included to assist in understanding the present application, however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated.

Claim 1:
A heart valve repair system comprising:
an implantable prosthetic device (<NUM>) including a coaption element (<NUM>), the implantable prosthetic device (<NUM>) being configured to attach to at least two leaflets (<NUM>, <NUM>) of a native heart valve of a patient and hold the at least two leaflets (<NUM>, <NUM>) in a relatively fixed position; and
a connector (<NUM>) that is separate from the implantable prosthetic device (<NUM>), the connector (<NUM>) including first and second tissue anchors (<NUM>, <NUM>) and being configured to be attached to the at least two leaflets (<NUM>, <NUM>) of the native valve of the patient when the at least two leaflets (<NUM>, <NUM>) are held by the implantable prosthetic device (<NUM>) in the relatively fixed position, the implantable prosthetic device being (<NUM>) configured to be detached from the at least two leaflets (<NUM>, <NUM>) and removed from the patient with the connector (<NUM>) remaining attached to the at least two leaflets (<NUM>, <NUM>).