Leaflet extension of heart valve leaflets

Abstract

A leaflet extension device for a heart valve leaflet and a method of treating a heart valve leaflet. Several embodiments are devices for addressing heart valve regurgitation including an expandable member and a cover. The expandable member has a stabilizing portion, a securing member opposite the stabilizing portion, and an engaging portion between the stabilizing portion and the expandable member. The stabilizing portion and the securing member sandwich a first native leaflet between the stabilizing portion and the securing member. The engaging portion protrudes inwardly from the stabilizing portion and the fixation member relative to a first native leaflet of the heart valve such that the engaging portion functionally extends the first native leaflet. The cover is attached to at least the engaging portion of the expandable member.

Description

[0001] This application is a divisional application of the Chinese invention patent application (application number: 201880100627.0, application date: November 14, 2018, invention name: Leaflet extension of heart valve leaflet). Technical Field

[0002] The present technology generally relates to implants and methods of implanting the same for repairing regurgitant or incompetent heart valves. The present technology is particularly useful for repairing a regurgitant mitral valve. Background Art

[0003] Conditions that affect the normal function of the mitral valve include, for example, mitral regurgitation, mitral valve prolapse, and mitral stenosis. Mitral regurgitation is a heart disease in which the leaflets of the mitral valve fail to coapt to apposition at peak systolic pressure, resulting in abnormal leakage of blood from the left ventricle to the left atrium. Several structural factors may affect the normal closure of the mitral valve leaflets. For example, the mitral valve annulus of many patients with heart disease is enlarged due to myocardial dilatation. The enlargement of the mitral valve annulus makes it difficult for the leaflets to coapt during systole. Stretching or tearing of the chordae tendineae (tendons connecting the papillary muscles to the underside of the mitral valve leaflets) may also affect the normal closure of the mitral valve annulus. For example, due to insufficient tension on the leaflets, ruptured chordae tendineae may cause the valve leaflets to prolapse into the left atrium. Abnormal regurgitation may also occur when the function of the papillary muscles is impaired, such as due to ischemia. Since the left ventricle contracts during systole, the affected papillary muscles cannot contract sufficiently to achieve normal closure.

[0004] Mitral valve prolapse, or when the mitral valve leaflets bulge abnormally into the left atrium, causes abnormal behavior of the mitral valve and may also lead to mitral regurgitation. The proper function of the mitral valve may also be affected by mitral stenosis, or a narrowing of the mitral valve orifice, which results in resistance to left ventricular filling during diastole.

[0005] Mitral regurgitation is often treated with diuretics and / or vasodilators to reduce the amount of blood flowing back into the left atrium. Other treatments, such as surgical approaches (open and endovascular), have also been used to repair or replace the valve. For example, typical repair approaches involve cinching or cutting off a portion of the dilated annulus.

[0006] Tightening of the annulus has been accomplished by implanting annular or peri-annular rings that are generally secured to the annulus or surrounding tissue. Other repair procedures also involve suturing or clipping the valve leaflets into partial apposition to one another.

[0007] Alternatively, more invasive procedures involve replacing the entire valve itself, where a mechanical valve or biological tissue is implanted into the heart to replace the mitral valve. These invasive procedures are typically done through large open-chest surgery and are therefore very painful, have high morbidity, and require a long recovery period.

[0008] However, in many repair and replacement procedures, device durability or improper sizing of the annuloplasty ring or replacement valve can cause additional problems for the patient. In addition, many repair procedures are highly dependent on the skill of the cardiac surgeon, where improper or inaccurate suture placement can affect the success of the procedure.

[0009] Compared to other heart valves, a portion of the mitral annulus has limited radial support from surrounding tissues, and the mitral valve has an irregular, unpredictable shape. For example, the inner wall of the mitral valve is limited only by the thin vessel wall that separates the mitral annulus from the lower portion of the aortic outflow tract. Therefore, significant radial forces on the mitral annulus may cause collapse of the lower portion of the aortic tract, with potentially fatal consequences.

[0010] The chordae tendineae of the left ventricle are often an obstacle to deploying mitral valve repair devices. The chordae maze in the left ventricle makes navigation and positioning of the deployment catheter in mitral valve repair more difficult.

[0011] In view of the difficulties associated with existing procedures, there remains a need for simple, effective, and less invasive devices and methods for treating dysfunctional heart valves. Summary of the invention

[0012] A valve repair device comprises: an expandable member including a frame having a plurality of interconnected struts defining a hollow volume, wherein the expandable member has a first portion configured to engage with a first native leaflet of a heart valve and a second portion configured to abut the atrial side of at least a portion of a second native leaflet of the heart valve; and a clamp extending from the second portion of the expandable member, wherein the clamp is configured to abut the ventricular side of at least a portion of the second native leaflet of the heart valve to clamp a portion of the second native leaflet between the second portion of the expandable member and the clamp to secure the expandable member to the second native leaflet. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 is a schematic diagram of the native mitral valve;

[0014] Figure 2A-2C A leaflet extension device configured to be attached to a native heart leaflet according to the present technology is shown;

[0015] Figure 3 is a side view of a frame-type expandable member according to the present technology;

[0016] Figure 4 A leaflet extension device according to the present technology is shown implanted in a mitral valve;

[0017] Figures 5A-5E A method of implanting a leaflet extension device according to the present technology is depicted;

[0018] Figure 6A-6B A leaflet extension device in accordance with the present technology is depicted;

[0019] Figure 7A-7B depicts a stabilizing portion of a leaflet extension device in accordance with the present technology;

[0020] Figures 8A-8B A leaflet extension device in accordance with the present technology is depicted;

[0021] Figures 9A-9E A leaflet extension device having a fixation member extending between chordae in accordance with the present technology is depicted;

[0022] Figures 10A-10B A leaflet extension device having a fixation element extending between chordae tendineae in accordance with the present technology is depicted;

[0023] Fig.11A and 11B A leaflet expansion device according to the present technology is shown;

[0024] Fig.12 A leaflet extension device according to the present technology is shown;

[0025] Figures 13A-13B A leaflet extension device in accordance with the present technology is depicted;

[0026] Figures 14A-14G A leaflet extension device in accordance with the present technology is depicted;

[0027] Figures 15A-15B A leaflet extension device in accordance with the present technology is depicted;

[0028] Fig.16 shows a stabilizing portion of a leaflet extension device according to the present technology;

[0029] Figures 17A-17D Other leaflet extension devices according to the present technology are shown;

[0030] Figures 18A-18C A leaflet extension device having an inflatable expandable member is shown;

[0031] Fig.19 An expandable member for a leaflet extension device according to the present technology is shown;

[0032] Fig. 20An expandable member for a leaflet extension device according to the present technology is shown;

[0033] Fig.21 depicts an enlarged view of an expandable member having a friction element in accordance with the present technology; and

[0034] Fig. 22 A leaflet extension device having an expandable member in accordance with the present technology is depicted. DETAILED DESCRIPTION

[0035] The present technology relates to heart valve devices, particularly devices for treating regurgitant or incompetent heart valves. Although many applications are described with respect to the mitral valve, the present technology is not limited to mitral valve applications. Devices of the present technology are intended to repair rather than replace the entire native valve.

[0036] Several embodiments of the present technology functionally extend one or more native leaflets to facilitate coaptation with other leaflets, thereby reducing regurgitation without puncturing the native leaflets. Some embodiments of the present technology are described with respect to the posterior leaflet of the mitral valve and providing an atraumatic coaptation surface for the anterior leaflet. However, the present technology can also be used to provide an atraumatic coaptation surface for the posterior leaflet while functionally extending the anterior leaflet.

[0037] Figure 1 An example of a mitral valve having an anterior leaflet and a posterior leaflet is shown. The anterior leaflet has a semicircular shape and is attached to two-fifths of the annular circumference. The movement of the anterior leaflet defines an important boundary between the inflow (diastole) and outflow (systole) tracts of the left ventricle. The posterior leaflet of the mitral valve has a crescent shape and is attached to approximately three-fifths of the annular circumference. The posterior leaflet typically has two well-defined indentations that divide the leaflet into three separate sectors, labeled P1 (lateral sector), P2 (middle sector), and P3 (medial sector). The three corresponding segments of the anterior leaflet are labeled A1 (anterior segment), A2 (middle segment), and A3 (posterior segment). The leaflet indentations facilitate the opening of the posterior leaflet during diastole.

[0038] like Figure 1 As shown, the mitral valve has anterolateral and posteromedial commissures, which define a distinct region where the anterior and posterior leaflets meet upon insertion into the annulus. Sometimes the commissures are present as well-defined leaflet segments, but more often the region is a subtle structure that can be identified using two anatomical landmarks: (a) the axes of the corresponding papillary muscles, and (b) the commissural chordae, which have a characteristic fan-shaped configuration. Several millimeters of valve tissue separate the free edges of the commissures from the annulus.

[0039] The mitral valve is an atrioventricular valve that separates the left atrium from the left ventricle. The mitral annulus constitutes the anatomical junction between the left ventricle and the left atrium. The fixed ends of the leaflets are attached to the annulus. The anterior portion of the mitral annulus is attached to the fibrous trigone, which is usually better developed than the posterior annulus. The right fibrous trigone is an area of ​​dense junction between the mitral valve, tricuspid valve, noncoronary flap of the aortic annulus, and the membranous septum. The left fibrous trigone is located at the junction of the left fibrous border of the aortic valve and the mitral valve.

[0040] The mitral annulus is poorly developed at the insertion site of the posterior leaflet. This segment is not attached to any fibrous structure, and the fibrous skeleton in this region is discontinuous. When mitral regurgitation occurs with left atrial or left ventricular dilatation, the posterior portion of the annulus tends to increase its circumference. The mitral annulus is saddle-shaped, and during systole, the commissural region moves proximally, that is, toward the top of the atrium, while the annular contraction also narrows the circumference. Both processes help achieve leaflet coaptation, which may be adversely affected by annular dilatation and calcification. The mitral annulus is surrounded by several important anatomical structures, including the aortic valve, coronary sinus, and circumflex artery.

[0041] Functional leaflet extension

[0042] Conventional approaches to addressing mitral valve annular dilatation have primarily focused on reshaping the annulus using an annuloplasty ring or connecting the anterior and posterior leaflets to facilitate coaptation. These approaches may not be suitable for situations where the gap or spacing between opposing leaflets is too large. Several embodiments of the present technology are leaflet extension devices that functionally extend and attach to native leaflets, such as without irreversibly disrupting the leaflets (e.g., without piercing and / or completely penetrating the leaflets), such that the leaflet extension device can be repositioned and / or removed as needed.

[0043] There have been attempts to extend the leaflets before. Some conventional approaches utilize an anchoring mechanism that pierces the leaflet. However, such approaches may be undesirable because they do not allow for repositioning and / or retrieval of the device. Other approaches use devices that extend the leaflets, but existing leaflet extensions are invasively attached to the leaflets by anchors that pierce the leaflets.

[0044] In contrast, leaflet extension devices of the present technology are non-invasively attached to the leaflets, eg, without puncturing the leaflets, to enable repositioning and / or removal of the leaflet extension devices as needed.

[0045] Figure 2A-2CA leaflet extension device 100 configured for attachment to a native heart valve leaflet is depicted. In some embodiments, the leaflet extension device 100 is configured to fill a 3-15 mm gap between the anterior leaflet and the posterior leaflet. Additionally, the leaflet extension device is configured to attach to the leaflet without irreversibly disrupting (e.g., permanently damaging) the leaflet. It is expected that this will enable the leaflet extension device to be removed and repositioned as needed.

[0046] Leaflet extension device 100 is configured to provide an artificial coaptation surface in place of one of the valve leaflets (anterior or posterior). For simplicity, device 100 will be explained with reference to the posterior leaflet of the mitral valve; however, device 100 is similarly applicable to the anterior leaflet of the mitral valve and the leaflets of other heart valves, such as the aortic valve or tricuspid valve.

[0047] Leaflet extension device 100 may include an expandable member 110 ( Figure 2A-2C 100 is a device 100 that is provided with a visor 136 and a cover 130. The device 100 has a coupling portion 112, a stabilizing portion 114, and a fixing member 116. The expandable member 110 has a delivery configuration suitable for delivery through the vascular system in a catheter and a post-expansion configuration. In the post-expansion configuration, the coupling portion 112 is positioned to provide an artificial coupling surface for one or more native valve leaflets, and the stabilizing portion 114 and the fixing member 116 are configured together to fix the device 100 relative to the valve anatomy. The cover 130 can be attached to the expandable member 110 or integral with the expandable member 110.

[0048] The expandable member 110 can be a frame with a mesh material, a lattice-work frame, and / or one or more struts, or the expandable member can include an expandable component (e.g., a sac / balloon) in addition to or in place of the frame. In the example shown, the expandable member 110 includes a frame with a main strut 120 (shown in dotted lines) and a cross strut 122 (shown in dotted lines). The main strut 120 can be connected at a first end 123 and extend to a second end 124 at the end of the fixing member 116. The main strut 120 can be configured to fan out from the first end 123 and bend in the area defining the joint portion 112 in the expanded configuration.

[0049] Figure 31 is a side view of a frame-type expandable member 110 without a cover 130. The main struts 120 can extend from a hub at a first end 123 and fan out to form an interior volume 132 within the engagement portion 112 and the stabilization portion 114. For example, the main struts 120 can be bent along a transition from the stabilization portion 114 and through the engagement portion 112, and then all or a subset of the main struts 120 can be further bent from the engagement portion 112 to define at least a portion of the fixation member 116. The fixation member 116 can be a clamp that contacts the stabilization portion 114 in the expanded configuration to apply a clamping force on the native leaflet. The fixation member 116 can alternatively be as Figure 3 Shown is separated from the stabilizing portion 114 by a gap 134. The cross-struts 122 may be configured to position the main struts 120 so that the main struts 120 maintain a desired configuration after deployment.

[0050] exist Figure 2A-3 In some examples depicted in , the engagement portion 112, the stabilization portion 114, and the fixation member 116 are integrally formed together. For example, the engagement portion 112, the stabilization portion 114, and the fixation member 116 may be integrally formed from a continuous main strut 120 or a cross strut 122 of the expandable member 110. In other examples, at least one of the engagement portion 112, the stabilization portion 114, and / or the fixation member 116 may be separate components from one another, or each of the engagement portion 112, the stabilization portion 114, and the fixation member 116 may be separate from one another.

[0051] refer to Figure 2A-2C , the coaptation portion 112 is intended to extend beyond the free end of the leaflet, thereby providing an artificial coaptation surface that functionally extends the native heart valve leaflet. The coaptation portion 112 may have any smooth shape that cooperates with the opposing leaflet. Figure 2A-2C The illustrated engagement portion 112 is a closed loop or ring, but the technology is not limited to the illustrated example, as smooth shapes may generally be used. The engagement portion 112 and the stabilizing portion 114 surround a hollow interior volume 132 ( Figure 2A and Figure 3 ). After implantation, the hollow volume 132 of the device 100 is at least partially filled with blood, which coagulates and is replaced by tissue over time. This can help to provide long-term fixation of the leaflet extension device 100. The engagement portion 112 together with the cover 130 provides an atraumatic engagement surface for the opposing (anterior) native leaflet.

[0052] When the expandable member 110 is a frame, it can include struts and / or meshes formed from any biocompatible material, such as plastic, stainless steel, or a superelastic self-expanding material (such as Nitinol, for example). The cover 130 can be a biocompatible fabric formed from a polymer or biomaterial (polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), silicone, urethane, pericardium, etc.). The cover 130 can be attached to the struts 120, 122 by sutures, adhesives, sintering, and / or other suitable attachment techniques.

[0053] In operation, the fixation member 116 is biased toward the stabilization portion 114 so that the native leaflet is clamped in the gap 134 between the fixation member 116 and the stabilization portion 114 when deployed. An aspect of several embodiments of the present technology is that the stabilization portion 114 and the fixation member (ventricular) 116 clamp onto the native leaflet without piercing the native leaflet. The fixation member 116 may include one or more clamps configured to clamp to the atrial side and the ventricular side of the leaflet, etc. Figure 2A-2C In the non-limiting example depicted in , the fixation member 116 can be a clamp adjacent to the ventricular side of the native leaflet, while the stabilization portion 114 is adjacent to the atrial side of the native leaflet, but this arrangement can be reversed if desired. In either case, the native leaflet is clamped (e.g., sandwiched) between the stabilization portion 114 and the fixation member 116. In some examples, the leaflet extension device 100 is attached to the native leaflet only by the compressive force of the stabilization portion 114 and the fixation member 116 without piercing the native leaflet.

[0054] refer to Figure 2A , the device 100 may also include a friction element 140, such as a wedge that engages or tents the leaflet. The friction element 140 may extend from the stabilizing portion 114 and / or the fixing member 116. For example, the friction element 140 may be attached to the stabilizing portion 114 and / or the fixing member 116 or formed integrally with the stabilizing portion 114 and / or the fixing member 116. The friction element 140 may be sharpened to facilitate engagement with the leaflet. In some cases, the friction element 140 may penetrate the native heart valve leaflet without completely piercing the native leaflet. In other cases, the friction element 140 completely pierces the full thickness of the native valve leaflet.

[0055] The leaflet extension device 100 is intended to be delivered and implanted in a beating heart using minimally invasive techniques. For example, the leaflet extension can be delivered via a catheter using a transfemoral approach. The leaflet extension device 100 is attached to the desired leaflet using a fixation member 116.

[0056] Stabilizing portion 114 and / or fixation member 116 may be sized to fit all or a portion of the native leaflet. When they fit the entire leaflet, they may support the torn leaflet. Alternatively, stabilizing portion 114 and / or fixation member 116 may be sized to fit only a portion of the native leaflet, e.g., central sector P2 of the posterior leaflet, leaving sectors P1 and P3 free to engage with the anterior leaflet (the opposite leaflet). In this example, P1 and P3 may be free to engage with the anterior leaflet (the opposite leaflet).

[0057] Figure 4 is an isometric view of the device implanted in the native mitral valve as viewed from the left atrium. Figures 5A-5D An example of implanting a leaflet extension device 100 at the native mitral valve is shown. The leaflet extension device 100 can be compressed into a tubular sheath for delivery via a transseptal or transatrial access. It can also be delivered via a transapical or transaortic access. Reference Figure 5A , the delivery catheter 500 or sheath can be positioned in the left atrium LA above the P2 portion of the posterior leaflet PL of the mitral valve. The device catheter 510 can then be advanced through the delivery catheter 500 and positioned at the native valve proximal to the middle of the P2 leaflet edge of the posterior leaflet PL, while the leaflet extension device 100 ( Figure 2A-3 ) is still contained within the device catheter 510, such as Figure 5B Reference Figure 5C When the fixation member 116 is subsequently partially released from the device catheter 510, the fixation member 116 is folded relative to the ventricular surface of the leaflet. During this process, the physician can confirm that the leaflet extension device 100 is at the proper height and that the fixation member 116 passes between the chordae tendineae. Figure 5D The process is shown after the fixation member 116 has been fully deployed and the stabilization portion 114 has been partially deployed such that the stabilization member is expanded medially and laterally. Figure 5E The leaflet extension device 100 is shown after it has been deployed so that the expansion member 110 ( Figure 3 ) has expanded to the deployed configuration. At this stage in the process, the posterior leaflet PL is sandwiched between the stabilizing portion 114 and the fixing member 114, while the anterior leaflet AL engages against the atraumatic surface of the engagement portion 112. Once the sheath is retracted to the atrial end of the device 100, the effectiveness of the device in reducing or eliminating mitral regurgitation can be evaluated. At this stage, the leaflet extension device 100 is functionally deployed but still connected to the delivery catheter. If the device 100 is functioning properly, it can be separated / detached from the delivery catheter. If not, the device catheter 510 and / or the delivery catheter 500 can be re-advanced to linearize and compress the device 100 for removal or repositioning.

[0058] The shape of the leaflet extension device 100 can be configured to enhance its effectiveness in engaging the native posterior leaflet and / or engaging the native anterior leaflet. Fig. 6A A leaflet extension device 100 is shown having a stabilizing portion 114 and / or a fixation member 116 configured such that they hold the posterior leaflet PL in a shape that approximates the natural curvature of the native leaflet. Figure 6B A leaflet extension device 100 is shown having a stabilizing portion 114 and / or a fixation member 116 configured such that they hold the native posterior leaflet PL in a relatively flat shape. Figure 6B The flat shape shown can position the leading edge of the primary leaflet and the chordae tendineae slightly closer to the anterior leaflet (not shown). The fusion portion 112 can have a slightly concave shape on the atrial side of the posterior leaflet PL, such as Figure 6B As shown, the engagement surface of the engagement portion 112 is positioned to engage with the native anterior leaflet. The engagement portion 112 may have a Fig. 6A A curved or even circular shape as shown in a cross section of Figure 6B The slightly more linear vertical shape shown in , allows the anterior leaflet to have a consistent engagement surface over the range of leaflet heights. The specific shape of the device 100 can be varied to account for different anatomical variations between patients, such as partially flail leaflets in patients with degenerative disease, or tethered leaflets in patients with functional mitral valve disease. The shape can also be varied to achieve a variety of types of engagement geometries. The engagement portion 112 can be relatively vertical. Other options include configurations in which the anterior leaflet can be closed against the ventricular aspect of the implant with a "trap-door" geometry.

[0059] Fig. 7A and 7B The leaflet extension device 100 is shown from the left atrium after implantation. The device 100 can extend along approximately 25-35 mm of the edge of the posterior leaflet PL and follow the curved edge of the posterior leaflet PL. The engagement portion 112 can be as shown. Fig. 7A bend slightly in the opposite direction as shown, or Figure 7B As shown it can be relatively straighter.

[0060] The length of the native leaflet measured from the annulus to the leaflet edge is in the range of about 20-30 mm. The stabilizing portion 114 of the device 100 is adjacent to the atrial surface of the posterior leaflet PL and can be relatively straight, such as Fig. 7A As shown, or the stabilizing portion 114 can be spherical (e.g., flared) to fit / support the Figure 7B As much surface area of ​​the native leaflets as shown.

[0061] The stabilizing portion 114 can extend beyond the fixed end of the leaflet and partially extend upward to the atrial wall above the mitral annulus, such as Fig. 8A This configuration of the stabilizing portion 114 increases the longitudinal dimension of the device 100, so that it can easily expand laterally and cover more atrial surface to further enhance the stability of the device 100. For example, such a long stabilizing portion 114 can support the device 100 against the atrial wall to inhibit the device 100 from flipping into the left atrium under systolic pressure, thereby helping to treat mitral regurgitation caused by posterior leaflet fluctuation or prolapse.

[0062] Fig. 8A The cover 130 of the device 100 shown can promote ingrowth into the atrial wall. This ingrowth can cause the middle sector P2 of the posterior leaflet to be permanently in a closed position, so that the middle sector P2 will effectively act as a stop. The device 100 can include an anchoring mechanism (not shown), such as a screw, a tack, an eyelet for a screw or tack, or a similar mechanism for securing the end of the stabilization portion 114 to the atrial wall or the mitral annulus.

[0063] The posterior leaflet of the human mitral valve typically has a gap between the posteromedial and anterolateral groups of chordae tendineae that may be approximately 8-10 mm wide, and the fixation member 116 may be configured to consistently position between the chordae tendineae (CT). Fig. 9A The fixation member 116 of the device 100 is shown configured to abut against the ventricular surface of the native posterior leaflet. Fig. 9A The illustrated fixation member 116 has a relatively narrow width and a pointed / rounded tip that can be predictably positioned in the gaps between the chordae tendineae CT.

[0064] Figures 9B-9D Shown as a line ( Fig. 9B ), spade-shaped( Fig. 9C ), or open ( Fig. 9C ) of various examples of fixing member 116. Figures 9B-9D The wider fixation member 116 shown may help stabilize the device 100, such as when a portion of the posterior leaflet may be fluctuating or prolapsed.

[0065] refer to Fig.9E , the fixation member 116 can extend to the naturally formed concave chamber AA between the ventricular wall muscle and the posterior leaflet. This extension of the fixation member 116 can enhance the stability of the device 100, and is expected to make it easier to form a more secure contact with the native leaflet and inhibit it from turning upward under systolic pressure.

[0066] In some previously described embodiments, one or more fixing members 116 extend through the gap between the posterior medial and anterolateral groups of the chordae tendineae and press against the ventricular surface of the posterior leaflet to keep the implant in a suitable position. One or more fixing members 116 can also extend more medially and laterally below the posterior leaflet, passing between the chordae tendineae anywhere they are convenient to pass through. Such embodiments may require that the device 100 be expanded laterally and inwardly before such fixing members extend between the chordae tendineae to avoid crowding in the central gap between the chordae tendineae. In several applications, it is desired that the fixing members 116 are only folded into the central gap between the medial and lateral groups of the chordae tendineae to alleviate the entanglement of the fixing members 116 with the chordae tendineae.

[0067] Fig. 10A A leaflet extension device 100 is shown having a first fixation member 116a and a second fixation member 116b. The first fixation member 116a may be similar to that described above with respect to Figure 2A-9E The second fixation member 116b is closer to the lateral and medial edges of the device, and in this case, it may be advantageous to deploy the second fixation member 116b or other ventricular element after the initial deployment of the device 100. For example, after the device 100 has been expanded medially and laterally, the second fixation member 116b can be advanced into the gaps between the chordae tendineae. In some embodiments, the second fixation member 116b can be advanced through tubes 1005 attached to the lateral and medial portions of the device 100. The tubes 1005 can be formed of polyimide, etc., and they can be attached to the expandable member 110 or the cover 130 of the device 100. For example, the tubes 1005 can be attached to the expandable member 110 at the same time as the cover 130 is attached, such as by sewing all of these elements to each other. It may be desirable that one or more struts ( Figure 2A-2C ) includes a cavity sized to accommodate the second fixation member 116b, thereby eliminating the need for tube 1005.

[0068] The second fixing member 116b may be formed of an elastic material, such as a superelastic nickel-titanium alloy (eg, ), pre-shaped to follow the shape of the implant after deployment, so that they are biased to apply pressure to the ventricular surface of the native leaflet. The second fixation member 116b can also include an atraumatic end, such as a paddle or ring, which has an increased surface area to maximize their clamping strength and reduce trauma to the native leaflet.

[0069] The device 100 can be more easily positioned in the native valve, and the fixation member 116 is not an integral continuation of the struts that form the coaptation portion 112. Thus, the fixation member 116 can be a separate strut that is advanced individually or together against the ventricular surface of the posterior leaflet. For example, Fig. 10BSuch a device 100 is shown having a fixation member 116 similar to the second fixation member 116b advanced through a tube 1005 to position it against the ventricular surface of the native leaflet.

[0070] Fig.11A and 11B 1 shows a variation of an expandable member 110 suitable for use with device 100. Expandable member 110 may be cut from a flat sheet of nickel-titanium alloy having a plurality of main struts 120 and cross struts 122. Fig.11A As shown, a plurality of central main struts 120 may extend continuously through the stabilizing portion 114, the engagement portion 112, and the fixation member 116. The stabilizing portion 114 of the struts 120 may be biased to bear against the atrial surface of the posterior leaflet, and the engagement portion 112 may be configured to define support for the artificial engagement surface. The engagement portion of the main struts 120 may be supported by cross struts 122 to enhance the stability of the device 100. Figures 11A-11B In the example shown, there are four main struts configured to abut against the atrial surface and five main struts 120 configured to define the structure of the engagement surface 112. The fixation structure 116 is supported by the three central main struts 120 such that the fixation structure 116 extends beneath the ventricular surface of the posterior leaflet.

[0071] To deliver the device 100 from a femoral vein access site via a transseptal puncture, the outer diameter of the entire device 100 and delivery system should generally not exceed 24 French (8 mm diameter), although larger diameters may be suitable for some applications. Thus, if the device 100 has nine main support struts 120 arranged in a linear pattern, as a non-limiting example, each main strut 120 may have a maximum width of 0.5 mm (0.020 inches).

[0072] To obtain a smaller diameter, the device 100 can be constructed by cutting a cylindrical nickel-titanium alloy tube having a plurality (perhaps 6-12) of linear elements (e.g., main struts 120). These linear elements can be connected by cross struts (e.g., chevrons) or other flexible elements to obtain strength, stability, and enhanced friction against the leaflet surface. Approximately half of the linear elements can define a stabilizing portion 114 that can be configured to follow the atrial surface of the posterior leaflet, and half of the linear elements can define a joining portion 112 that can be bent to form a leaflet extension shape.

[0073] Fig.12An embodiment of the device 100 is shown with a slightly flatter shape and transverse struts 122 that protrude outward to enhance fixation. In such an embodiment, the transverse struts 122 at the edge of the device 100 may be further extended laterally and medially to further stabilize the device 100. If a portion of the posterior leaflet is undulating or there is misalignment between the P1-P2 segment or the P2-P3 segment of the native leaflet, such expanded transverse struts 122 may further stabilize and align the leaflet segments.

[0074] Fig.13A and 13B Aspects of an expandable member 110 of a device 100 having a separate fixation member 116 are shown. A main strut 120 can extend from a first end 123 and through a stabilization portion 114 and a coupling portion 112 such that the main strut 120 extends to a point below the posterior leaflet. The device 100 can have a main strut 120 having a cavity through which the separate fixation member 116 can be moved from a retracted position to an extended position. Thus, the separate fixation member 116 can extend from the main strut 120 to engage the ventricular surface of the native leaflet and hold the implant 100 in place. Fig.13A The device 100 in the embodiment has independently advanceable fixation members 116 at the lateral and medial edges of the implant 100. Alternatively, Fig. 13B All of the fixation members 116 of the illustrated device 100 can be advanced independently. The main support 120 can be a hollow metal or polymer tube. In other embodiments, Fig.13A and 13B The device 100 shown has a solid main strut 120 and a separate tube (such as a polyimide tube) is attached to the main strut 120. If such a separate tube is attached to the side of the main strut 120 corresponding to the inner diameter of the tube, then when the implant 100 is compressed for delivery, the diameter of the entire device will be minimized. The joint portion 112 can be covered with a fabric cover as described above.

[0075] Fig. 13B Also shown is an extension mechanism 1310 for extending / retracting the fixing member 116. The extension mechanism 1310 can include a separate wire having a proximal portion 1314, a distal portion 1316, and an atraumatic top 1318. The distal portion 1316 and the top 1318 of the wire define the fixing member 116. The proximal portion 1314 of each movable wire can extend proximally to a handle or be releasably attached to a separate delivery wire (push-wire) in the delivery system. This will enable each wire to be independently moved to a suitable position. Alternatively, the extension mechanism 1310 may have a plunger 1312, and one or more wires may be attached to the plunger 1312 so that the wires attached to the plunger can all be advanced / retracted simultaneously (e.g., Fig. 13BThis will simplify the structure of the delivery catheter, speed up the implantation process, and simplify the release of the implant from the delivery catheter.

[0076] Figures 14A-14D The device 100 is shown with an engagement portion 112 that is independently deployed relative to a stabilization portion 114. For example, the engagement portion 112 can have separate elements that are deployed by advancing them relative to elements of the stabilization portion 114. The engagement portion 112 can be adjustable so that by further advancing the engagement portion relative to the stabilization portion 114, the implant 100 can be expanded to further improve engagement.

[0077] Fig.14A and 14B Some embodiments of the device 100 are shown in which the stabilizing portion 114 and the engaging portion 112 are connected at a distal region of the stabilizing portion 114. More specifically, the stabilizing portion 114 has a first main strut 120a and an eyelet 1410 at an end of the first main strut 120a, and the engaging portion 112 has a second main strut 120b configured to extend through the eyelet 1410. The device 100 may also include a cross strut 122 between the first main struts 120a of the stabilizing portion 114. The first main struts 120a of the stabilizing portion 114 can be cut from a flat metal sheet (e.g., a shape memory material such as Nitinol), and the second main struts 120b of the engaging portion 112 can be cut from a second metal sheet (e.g., a shape memory material such as Nitinol; see, e.g., Fig.14A and 14C ) cut.

[0078] Fig. 14B and 14D It shows how the first and second main struts 120a-b are configured to have a curved shape that approximates a desired final shape in the expanded state. Fig.14A and 14B The illustrated device 100 has a central second main strut 120 b connected at its distal end to define a fixation portion 116 . Fig. 14C and 14D The device 100 shown has separate second main struts 120b that are bent apart from each other to define a plurality of fixation members 116. The second main struts 120b of the engagement portion 112 pass through openings / eyelets 1410 at the distal end of the first main struts 120a of the stabilization portion 114. The resulting first and second main struts 120a and 120b can be held together at the proximal end of the device 100.

[0079] Once the device 100 is deployed and the stabilizing portion 114 is pressed against the surface of the posterior leaflet and expanded laterally and medially, the engagement portion 112 can be further advanced so that the distal extension of the second main strut 120b defining the fixation member 116 is folded down against the ventricular surface of the posterior leaflet. This action clamps the device 100 in place while simultaneously raising the engagement portion 112 and extending the posterior leaflet toward the anterior leaflet.

[0080] Figures 14E-14G Shows Fig. 14C and 14D The apparatus 100 is shown in an expanded order. Fig.14E The device 100 is shown after it has been partially exposed from a distal portion of a delivery catheter 1420. At this point, the stabilizing portion 114, the engaging portion 112, and the fixation member 116 can be at least substantially aligned with one another. Fig.14F shows the device 100 after the engagement portion 112 begins to bend, Figure 14G Device 100 is shown after stabilization portion 114, engagement portion 112, and fixation member 116 have been moved to their post-deployment shapes.

[0081] Fig.15A and 15B shows a similar Figure 2A-14G The leaflet extension device 100 embodiment of any device shown and described, but Fig.15A and 15B The device 100 in the embodiment has an atrial stabilizer 1510 . Fig.15A and 15B The device 100 shown can have a stabilizing portion 114 having an eyelet 1410, a coupling portion 112, and a fixing member 116. In the illustrated embodiment, the stabilizing portion 114 has a first main strut 120a, the coupling portion 112 has a second main strut 120b extendable from the first main strut 120a, and the fixing portion 116 can have a third main strut 120c. The stabilizing portion 114 and the fixing member 116 can also include a cross strut 122. The coupling portion 112 can slide through the eyelet 1410 to extend the coupling portion 112 and the fixing member 116 relative to the stabilizing portion 114, as described above with respect to Figures 14A-14G described.

[0082] The atrial stabilizer 1510 is configured to engage the atrial wall of the heart. The atrial stabilizer 1510 is depicted as a rectangular element surrounding an opening 1520, but the atrial stabilizer 1510 can be a strut or a series of struts or any polygonal, circular, elliptical, oblong, or other shape suitable for engaging the atrial wall. In use, the atrial stabilizer 1510 is configured to contact or otherwise engage the atrial wall, and the atrial stabilizer 1510 can include friction elements, such as wedges and / or fabric coverings. The atrial stabilizer 1510 can also include a fabric covering to promote tissue ingrowth and / or encapsulation, which can provide additional long-term fixation for the leaflet extension device 100.

[0083] Fig.15A and 15B The leaflet extension device 100 is configured to be deployed with the stabilizing portion 114 pressed against the atrial surface of the posterior leaflet and expanded laterally and medially. Advancement of the engagement portion 112 causes the fixation member 116 to fold against the ventricular surface of the posterior leaflet, thereby clamping the device in place while simultaneously raising the engagement portion 112 and extending the posterior leaflet toward the anterior leaflet.

[0084] The device 100 shown and described above with respect to 14A-15B may include additional features for specific functions. For example, advancing the engagement portion 112 relative to the stabilizing portion 114 may simultaneously deploy friction elements, barbs, chevrons, or anchors formed with and / or on the stabilizing portion 114. For example, advancing the engagement portion 112 may drive such friction elements downwardly against, into, or through the atrial surface of the native leaflet. The device 100 may also include a locking element (not shown) that locks the engagement portion 112 in a specific position relative to the stabilizing portion 114. For example, the device may have a locking tab or element that is selectively deployed to extend more or less to the native leaflet. Moreover, the relative thickness of the stabilizing portion 114, the engagement portion 112, and the fixing member 116 at each point along their length may vary to achieve a desired range of shapes based on the degree of deployment. In an alternative configuration, the engagement portion 112 may have a separate second main strut 120b that may be advanced separately to adjust the relative extension of the device 100 along the line of engagement.

[0085] Fig.16 A leaflet extension device 100 is shown having an expandable member 110 that includes an expandable balloon or bladder 1610. In addition to or in lieu of a frame having one or more main struts and / or cross struts, the expandable balloon or bladder 1610 may be used in conjunction with the above-referenced Figure 2A-15BAny of the leaflet extension devices 100 described and shown. Once the device is in place at the native valve, the expandable balloon 1610 can be expanded. The balloon 1610 can have a coupling portion 112 configured to face the opposing leaflet so that the balloon 1610 engages the opposing leaflet. The balloon 1610 can be inserted into the hollow interior volume 132 (enclosed by the stabilizing portion 114 and the coupling portion 112 shown and described above with reference to 2A) Figure 2A ). Inflating the balloon 1610 pushes the coaptation portion 112 toward the opposing heart valve leaflet (eg, the anterior leaflet). The balloon 1610 can be inflated to the extent necessary to provide coaptation with the native anterior leaflet and eliminate regurgitation.

[0086] Leaflet extension with actively displaceable base member

[0087] Figures 17A-17D An example leaflet extension device 1200 is shown that includes two members 1702, 1704. Member 1702 has a first end 1702A and an opposing second end 1702B. Member 1704 has a first end 1704A and an opposing end 1704B. Second end 1702B is attached to second end 1704B using conventional attachment methods including screws, rivets, etc. Members 1702, 1704 can be formed from any biocompatible material, including plastics, metals, etc. For example, members 1702, 1704 can be formed from stainless steel, nickel titanium alloys (such as ), or cobalt-chromium-nickel-molybdenum alloy (such as ) Members 1702 and 1704 may be formed from solid sheets of material, a mesh, one or more struts, a lattice frame, or the like.

[0088] Member 1702 has a first face 1702F and an opposite second face 1702G. Member 1704 has a first face 1704F and an opposite second face 1704G. The first face 1702F of the first member 1702 is adjacent to the first face 1704F of the second member 1704. The first end 1704A of the second member 1704 is not attached to the first member 1702 and is elastically displaceable relative to the first member 1702.

[0089] The first and second members 1702, 1704 cooperate to clamp and grip the first native leaflet without piercing the leaflet. The first and / or second members may include friction fit members that can friction fit with the native heart valve leaflet (insert without piercing), or friction fit elements that can pierce without piercing the native heart valve leaflet.

[0090] Leaflet extension device 1700 includes an engagement element 1703 attached to second face 1702G of first member 1702. Engagement element 1703 may have a teardrop shape and may include a raised portion 1703C extending beyond second end 1702B, preferably with a smooth outer surface for atraumatic engagement with a second native leaflet (not shown).

[0091] The joining element 1703 may be formed of a biocompatible foam, which may or may not include an internal frame. Alternatively, the joining element 1703 may be formed of a frame 1708 formed of one or more interconnected struts or meshes. The frame 1708 encloses a hollow interior volume sealed by the fabric cover 1210.

[0092] The tether 1712 is operably connected to the first and second members 1702, 1704. In some embodiments, the tether 1712 is used to actively displace the second member 1204 relative to the first member 1702. The tether can be formed of a variety of biocompatible materials, including metal wires, such as stainless steel, polymer sutures formed of expanded polytetrafluoroethylene (ePTFE), ultra-high molecular weight polyethylene (UHMWPE), or polyester.

[0093] The first member 1702 and / or the second member 1704 may be formed of a superelastic alloy, which elastically deforms from a natural shape to a deformed shape in response to an external force, but restores the natural shape once the external force is removed, wherein pulling the tether 1712 causes the second member 1704 to elastically shift relative to the first member 1702.

[0094] An atrial stabilization member 1718 can be disposed on end 1702A- 1 of the first member 1702 , which can be attached to a wire form that helps provide atrial stabilization.

[0095] Leaflet extension with expandable member

[0096] In some cases, it may be desirable to increase the effective clamping force. Adding an expandable element between the native leaflet and the fixation member 116 or stabilization portion 114 may increase the effective clamping force against the leaflet and improve the fixation of the leaflet extension device 100. For example, Figures 18A-18C A device is shown that includes an expandable element 1810. Although the expandable element 1810 can be placed on the atrial side of the leaflet, the present disclosure focuses on adding the expandable element 1810 between the fixation member 116 of the leaflet extension device and the ventricular surface of the native heart valve leaflet. Having the expandable element below the leaflet can limit the movement of the device and provide a more stable structure for the opposing leaflet to abut.

[0097] For example, the expandable element 1810 can also limit the movement of the leaflets by interfering with the ability of the leaflets to fully open. The expandable element 1810 can expand toward the ventricular wall so that the expandable element contacts the ventricular wall intermittently or continuously during the cardiac cycle. This can be advantageous for many reasons. It can stabilize the device 100 and / or the leaflets, reduce excessive movement and any wear, stress, or trauma on the implant, the trapped leaflet, the anterior leaflet, or the adjacent leaflets.

[0098] The expandable element 1810 can potentially reduce any regurgitation in the repaired valve in a number of ways. It can improve the ability of the leaflet extension device 100 to engage with the opposing leaflet by pushing the leaflet extension device 100 toward the opposing leaflet. It can also improve the ability of the prosthetic device 100 to engage with adjacent leaflets (such as the P1 and P3 flaps of the posterior leaflet) by holding the P2 leaflet in a more appropriate position or by creating a surface against which the P1 and P3 can engage.

[0099] Figures 18A-18C An example of an expandable element 1810 is shown in cross-section. Fig.18A The device 100 is shown when it is first placed, Fig.18B and 18C is after the expandable element 1810 is expanded. The cross-sectional shape of the expandable element 1810 can have a variety of profiles, such as Fig.18B and 18C For example, the native leaflets can be maintained in a flat or curved shape, the cross-section of the expandable element 1810 can be generally circular, triangular, or polygonal, and the expandable element 1810 can extend toward or away from the ventricular wall.

[0100] In addition to the cross-sectional profile of the expandable element 1810, the profile of the expandable element 1810 in other dimensions is also important. For example, the fixation member 116 can be made with a relatively narrow distal profile to allow it to be more easily placed in the chord-free region of the posterior leaflet. When the expandable element 1810 is expanded between the fixation member 116 and the ventricular surface of the leaflet, the distal end of the expandable element 1810 can be wider where it contacts the ventricular surface of the leaflet, such as Fig.18B and 19 This can give the expandable element 1810 a slightly triangular profile facing the ventricular wall. Closer to the leaflet edge, the fixation member 116 can be about as wide as the chord-free region of the leaflet edge, and the expandable element 1810 can be as wide or slightly wider.

[0101] As described above, the expandable element 1810 can extend posteriorly to always contact or press against the ventricular wall. Alternatively, it can be designed to minimize contact with the posterior wall so that it is possible for the posterior leaflet to at least maintain a certain range of motion. This will allow the posterior leaflet to open slightly during diastole, reducing any potential gradient across the mitral valve. Such a shape can also allow the leaflet and implanted device to be pushed out of the way against the ventricular wall if an artificial replacement mitral valve needs to be implanted at a later time.

[0102] The expandable element 1810 can also be designed to expand laterally beneath the ventricular side of the valves P1 and P3 of the native leaflets. The lateral expansion of the expandable member 110 can bridge any gaps between P1 and P2 or P2 and P3. They can also maintain P1 and P3 in a generally closed position aligned with the P2 leaflet. However, there may be support chords, tertiary chords, or even primary chords that may interfere with the expansion of these lateral extensions. Therefore, these lateral extensions can be designed as very low pressure, highly expandable balloon elements that can expand around and between the chordae, or they can be multiple finger-like extensions to extend between the chordae, such as Fig. 20 shown.

[0103] The expandable element 1810 itself may include an inflatable balloon or sac. The sac may be configured to expand to a specific size and shape to achieve the specific design goals described above. Alternatively, it may be an expandable elastic balloon that expands in a more spherical shape until it is constrained by the rest of the device, the chordae tendineae or valve leaflets, or the ventricular wall.

[0104] The expandable element 1810 may also have a rigid or semi-rigid element attached thereto. Fig.21 , the device may include friction elements 2114, such as ridges, spikes, or other features that improve the friction fit with the valve leaflets. Alternatively, the friction elements 2114 may be rigid or semi-rigid linear elements to constrain the expandable element 1810 to the possible shapes described above, such as triangular, prismatic, or polyhedral shapes. For example, the expandable element 1810 may have rigid linear elements fixed to a surface juxtaposed with the ventricular surface of the leaflet to help it fit securely with an area of ​​the leaflet. When the expandable element 1810 is folded for delivery, these elements will align with the fixing member 116 to minimize the delivery profile. These rigid linear elements may also have ridges, grooves, ridges, spikes, or other features that further enhance the friction fit with the surface of the valve leaflets.

[0105] The expandable element 1810 can be a balloon or sac made of any biocompatible material such as urethane, expanded PTFE, polyester, polyolefin, or other materials, or combinations thereof. For example, the sac can have an outer surface of expanded PTFE to optimize tissue ingrowth and tissue compatibility of the bonding surface, and an inner layer of urethane to seal the sac for leak-free expansion.

[0106] During delivery, the expandable element 1810 can be delivered with an expansion tube inserted for expansion. The expansion tube will extend upward through the delivery catheter of the device. Once the expandable element 1810 is expanded to the desired shape or volume, the tube can be withdrawn to allow the expandable element 1810 to be permanently expanded to that size.

[0107] The expandable element 1810 can be expanded with one or more polymers that are cross-linked or cured over a period of time so that the size and shape of the sac are permanent. Examples of such polymers are polyethylene glycol, silicone, methacrylate, etc. The expandable element 1810 can also be filled with a coiled and / or braided structure formed by a biocompatible material. These coils can be similar to coils used for winding within a blood vessel. Alternatively, the expandable element 1810 can be expanded with saline or other biocompatible solutions that remain liquid forever. In this way, if you want to shrink the expandable element 1810 in the future, for example to make room for implanting an artificial mitral valve, this can be achieved by piercing the sac with a needle to burst it open. This can be done using interventional catheter technology.

[0108] The expandable element 1810 may alternatively be made of an elastomeric member or expandable mechanical structure. For example, the expandable element 1810 may be an attached superelastic frame, braid, coil, or mesh. This would allow it to be rolled up to a low profile for delivery and then self-expand once it is in place. The braid or mesh structure may also be made of stainless steel or a cobalt-chromium-nickel-molybdenum alloy (e.g., ) Such an expandable element 1810 may have an opening that allows the interior volume to be filled with blood during or after expansion.

[0109] The previous embodiments have described an implantable leaflet extension device having a fixation and stabilization element made of a superelastic nickel-titanium alloy (e.g., ) frame that can be folded around the edges of the valve leaflets. Alternatively, the frame can be made of stainless steel, cobalt-chromium steel, "super alloys" (such as 39-41% cobalt, 19-21% chromium, 14-16% nickel, 11.3-20.5% iron, 6-8% molybdenum, and 1.5-2.5% manganese) ), or other biocompatible metals or metal alloys that are stronger and more rigid than the posterior leaflet but do not exhibit similar superelasticity. If the leaflet extension device 1300 were made of these metals, it would be elastic enough to fan out laterally but not elastic enough to fold around the leaflet edge. Therefore, such a device with a non-superelastic frame can be preformed into a U-shape so that it can be hooked under the posterior leaflet, such as Fig. 22 Such a device could also be shaped as a "V" with sharp edges rather than curved edges along the edge of the extended posterior leaflet. Such a design would not necessarily enclose a volume filled with blood.

[0110] The open end 2212 of the U can be formed with a 3-5 mm opening that is large enough to allow the leaflet to be hooked. Once the device is in place, the expandable element as described above can be inflated or expanded to clamp the leaflet. If the leaflet extension device 100 does not appear to be able to sufficiently reduce valve regurgitation, the device 100 can be pushed away from the posterior leaflet and retracted into the delivery sheath. The 3-5 mm opening is small enough that the proximal end of the hook can be captured by the open end of the sheath. Then, as the sheath is advanced over the device, it will compress the leaflet extension that has expanded laterally.

Claims

1. A valve repair device, comprising: an expandable member comprising a frame having a plurality of interconnected struts defining a hollow volume, wherein the expandable member has a first portion configured to engage a first native leaflet of a heart valve and a second portion configured to abut an atrial side of at least a portion of a second native leaflet of the heart valve; and A clamp extends from the second portion of the expandable member, wherein the clamp is configured to abut the ventricular side of at least a portion of a second native leaflet of the heart valve to clamp a portion of the second native leaflet between the second portion of the expandable member and the clamp to secure the expandable member to the second native leaflet.

2. The valve repair device according to claim 1, wherein the portion of the second native leaflet is a central portion of the second native leaflet.

3. The valve repair device according to claim 1, wherein the heart valve is a mitral valve, wherein the second native leaflet is a posterior leaflet of the mitral valve, and wherein a portion of the posterior leaflet is a middle sector P2 of the posterior leaflet.

4. A valve repair device according to claim 3, wherein the first native leaflet is the anterior leaflet of the mitral valve, and wherein the size of the expandable member allows at least one side sector of the posterior leaflet to engage with the anterior leaflet.

5. The valve repair device of claim 1, wherein the heart valve is a mitral valve, wherein the first native leaflet is an anterior leaflet of the mitral valve, and wherein the second native leaflet is a posterior leaflet of the mitral valve.

6. The valve repair device according to claim 1 further includes a covering on the frame along at least a first portion of the expandable member, wherein the covering is configured to provide a non-traumatic engagement surface for the first native leaflet along the first portion of the expandable member.

7. The valve repair device of claim 1, further comprising a covering on at least a portion of the clamp.

8. The valve repair device of claim 1 further comprising a plurality of friction elements extending from the second portion of the expandable member.

9. The valve repair device according to claim 8, wherein the size of the plurality of friction elements is suitable for penetrating into the atrial side of the second native leaflet without completely piercing the second native leaflet.

10. The valve repair device according to claim 8, wherein the size of the plurality of friction elements is suitable for penetrating into the atrial side of the second native leaflet and completely piercing the second native leaflet.

11. The valve repair device of claim 1, further comprising a plurality of friction elements extending from the clamp.

12. The valve repair device according to claim 11, wherein the plurality of friction elements are sized to penetrate into the ventricular side of the second native leaflet without completely piercing the second native leaflet.

13. The valve repair device of claim 1, wherein the clip is separate from the expandable member and coupled to the expandable member.

14. The valve repair device according to claim 1, wherein the clamp is formed integrally with the expandable member.

15. The valve repair device of claim 1, wherein the clamp is capable of actively displacing relative to the second portion of the expandable member.

16. The valve repair device of claim 1, wherein the clamp is biased toward the second portion of the expandable member.

17. A valve repair device, comprising: an expandable member comprising a frame having a plurality of interconnected struts defining a hollow volume, wherein the expandable member has an engagement portion configured to engage a first native leaflet of a heart valve and a stabilization portion configured to abut an atrial side of at least a portion of a second native leaflet of the heart valve; and A fixing member extends from the stabilizing portion of the expandable member, wherein the fixing member is configured to abut the ventricular side of at least a portion of a second native leaflet of the heart valve to clamp a portion of the second native leaflet between the stabilizing portion of the expandable member and the fixing member, thereby fixing the expandable member to the second native leaflet.

18. The valve repair device of claim 17, wherein the fixing member is separate from and coupled to the expandable member, and wherein, The fixation member is capable of being actively displaced relative to the stabilizing portion of the expandable member.

19. A valve repair device for treating a mitral valve, comprising: an expandable member comprising a frame having a plurality of interconnected struts defining a hollow volume, wherein the expandable member has a first portion configured to engage an anterior leaflet of a mitral valve and a second portion configured to abut an atrial side of at least a portion of a posterior leaflet of the mitral valve; and A clamp extends from the second portion of the expandable member, wherein the clamp is configured to abut the ventricular side of at least a portion of the posterior leaflet of the mitral valve to clamp a portion of the posterior leaflet between the second portion of the expandable member and the clamp, thereby securing the expandable member to the posterior leaflet.

20. The valve repair device of claim 19, wherein the clip is separate from and coupled to the expandable member, and wherein the clip is capable of actively displacing relative to a second portion of the expandable member.

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