Annuloplasty ring with posterior leaflets for minimally invasive treatment

Abstract

An annuloplasty ring is disclosed. The annuloplasty ring includes an outer tube, a plurality of anchors, and at least one synthetic leaflet. The synthetic leaflet is in mechanical communication with the annuloplasty ring at a plurality of points. The outer tube includes a plurality of windows. A plurality of anchors are positioned within the outer tube and around a periphery of the outer tube. The plurality of anchors are configured to extend from the plurality of windows to anchor the annuloplasty ring to a heart valve of a patient.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 859,975, filed on June 11, 2019, entitled “ANNULOPLASTY RING WITH POSTERIOR LEAFLET FOR MINIMALLY INVASIVE TREATMENT,” which is hereby incorporated by reference in its entirety. Technical Field

[0003] The present disclosure relates to implantable prosthetic devices. More particularly, the present disclosure relates to improved prosthetic devices that are implantable via a catheter for treating mitral or tricuspid valve regurgitation. Background Art

[0004] Mitral regurgitation is a valve dysfunction that causes blood volume to flow during systole from the left ventricle to the left atrium (during left ventricular contraction), which is opposite to a healthy heart where flow in this direction is blocked by the mitral valve. The reverse flow during systole causes increased pressure in the left atrium. Maintaining normal cardiac output results in increased left ventricular pressure.

[0005] Treatment Patients with mitral regurgitation (MR) or tricuspid regurgitation (TR) may require valve replacement in order to reduce or eliminate the regurgitation. For many years, the commonly accepted treatment was surgical repair or replacement of the native valve during open heart surgery. In recent years, transvascular techniques have been developed for introducing prosthetic heart valves and implanting prosthetic heart valves using flexible catheters in a less invasive manner than open heart surgery.

[0006] In the transvascular technique, the prosthesis is delivered via a catheter to the target site (aortic, mitral, tricuspid or other valve), with the device crimped to a low diameter shaft and stretched / expanded to its functional size when it is in the correct position.

[0007] The catheter can be advanced to the target site: (a) transvascularly, where the catheter is advanced from the femoral vein / artery or any other vessel that allows access to the target site; (b) transapically, where the catheter is advanced through a small incision made in the chest wall and then through the apex of the heart; (c) transatrially, where the catheter is advanced through a small incision made in the chest wall and then through the left or right atrium. Summary of the invention

[0008] Some embodiments disclosed herein relate to an annuloplasty ring for heart valve repair. In some embodiments, the annuloplasty ring may have a first end and a second end opposite the first end. The annuloplasty ring may be configured to have an elongated insert geometry and an annular operable geometry. The annuloplasty ring may also include a plurality of anchors within the annuloplasty ring. The plurality of anchors may have an expanded configuration in the annular operable geometry. The annuloplasty ring may include at least one synthetic leaflet that is mechanically connected to the annuloplasty ring at multiple points. In some embodiments, at least one synthetic leaflet may include a valve frame having a proximal opening and a synthetic leaflet material mechanically coupled to the valve frame. The synthetic leaflet material may be located within the proximal opening. In some embodiments, the valve frame may include a shape memory metal. In other embodiments, the synthetic leaflet material may include a polymer material.

[0009] In some embodiments, at least one synthetic leaflet of the annuloplasty ring may include a plurality of leaflets. In further embodiments, the plurality of leaflets may have a first leaflet positioned adjacent to a first end of the annuloplasty ring and a second leaflet positioned adjacent to a second end of the annuloplasty ring. In some embodiments, at least a portion of the first leaflet and the second leaflet are mechanically coupled.

[0010] In some embodiments, at least one synthetic leaflet is in mechanical communication with the annuloplasty ring at multiple points on the posterior or anterior side of the native valve.

[0011] In additional embodiments, the annuloplasty device may further include a plurality of anchor windows, a coating, a DACRON (i.e., polyethylene terephthalate) coating, a shape memory metal, or a combination thereof. In some embodiments, at least one synthetic leaflet may include one or more band holes. In further embodiments, the annuloplasty ring may further include at least one snap mechanism configured to connect the first end and the second end.

[0012] Additional embodiments disclosed herein relate to anchoring devices. The anchoring device may include a leaflet anchor having an anchor body having a first end and a second end. The leaflet anchor may also include an anchor portion mechanically connected to the first end of the leaflet anchor. In some embodiments, the leaflet anchor may also include a separation element mechanically connected to the second end of the leaflet anchor, and a distal portion mechanically connected to the anchor body between the first end and the second end. In some embodiments, the separation element may be configured to rotate the anchor body. In additional embodiments, the anchor portion or the anchor body may include a shape memory metal.

[0013] Additional embodiments disclosed herein relate to methods of delivering an annuloplasty ring in an elongated insertion geometry, wherein delivery of the annuloplasty ring utilizes one of a transapical approach, a transseptal approach, a transfemoral approach, a transjugular approach, and a transatrial approach. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Aspects, features, benefits and advantages of the embodiments described herein will become apparent with reference to the following description, appended claims and accompanying drawings, in which:

[0015] Figure 1 An annuloplasty ring having at least one synthetic leaflet is depicted according to an embodiment.

[0016] Figure 2 An annuloplasty ring having at least one synthetic leaflet is shown in an open configuration according to an embodiment.

[0017] Figure 3 Depicted is a cross-sectional view of an annuloplasty ring in an elongated insertion geometry, according to an embodiment.

[0018] Figure 4 A perspective view of an annuloplasty ring having at least one synthetic leaflet is shown in accordance with an embodiment.

[0019] Figure 5A is a perspective view depicting delivery of an annuloplasty ring having at least one synthetic leaflet, according to an embodiment.

[0020] Figure 5B A side view of an annuloplasty ring having at least one synthetic leaflet is shown according to an embodiment.

[0021] Figure 5C is a perspective view depicting delivery of an annuloplasty ring having at least one synthetic leaflet, according to an embodiment.

[0022] Figure 6 is a perspective view of an annuloplasty ring having at least one synthetic leaflet in an open configuration according to an embodiment.

[0023] Figure 7 An annuloplasty ring having at least one anterior synthetic leaflet and at least one posterior synthetic leaflet is depicted according to an embodiment.

[0024] Figure 8 is a cross-sectional view of an annuloplasty ring having at least one anterior synthetic leaflet and at least one posterior synthetic leaflet, according to an embodiment.

[0025] Fig. 9 is a top view of an annuloplasty ring having at least one anterior synthetic leaflet and at least one posterior synthetic leaflet secured to native leaflets with leaflet anchors, according to an embodiment.

[0026] Fig.10 is a side view of an annuloplasty ring having at least one synthetic leaflet, according to an embodiment.

[0027] Fig.11A A leaflet anchor is shown according to an embodiment.

[0028] Fig. 11B Depicted is a deployed leaflet anchor according to an embodiment.

[0029] Fig. 11C A deployed leaflet anchor is shown according to another embodiment.

[0030] Fig.12 is a top view of an annuloplasty ring having at least one postsynthetic leaflet, according to an embodiment.

[0031] Fig.13 An annuloplasty ring having multiple synthetic leaflets is depicted according to an embodiment. DETAILED DESCRIPTION

[0032] As used herein, the term "about" refers to changes in the amount of values ​​that may occur, such as by measurement or processing procedures in the real world; by unintentional errors in these procedures; by differences in the manufacture, source or purity of compositions or reagents; and so on. Typically, as used herein, the term "about" refers to greater than or less than the value or greater than 1 / 10 of the value or less than 1 / 10 of the value of the range of the value, such as ± 10%. The term "about" also refers to variations that those skilled in the art will recognize as equivalent forms, as long as such variations do not cover known values ​​practiced in the prior art. Each value or range of values ​​preceded by the term "about" is also intended to cover embodiments of the absolute value or range of values. Whether or not modified by the term "about", the quantitative values ​​described in the claims include equivalent forms of the values, for example, variations in the amount of values ​​of such values ​​that may occur, but those skilled in the art will recognize that this is an equivalent form.

[0033] The terms "patient" and "subject" are interchangeable and can be used to refer to any living organism. Therefore, the terms "patient" and "subject" can include, but are not limited to, any non-human mammal, primate, or human. In some embodiments, the "patient" or "subject" is a mammal, such as a mouse, rat, other rodent, rabbit, dog, cat, pig, cow, sheep, horse, primate, or human. In some embodiments, the patient or subject is an adult, child, or infant. In some embodiments, the patient or subject is a human.

[0034] When a replacement valve (e.g., an aortic valve, mitral valve, tricuspid valve, or other valve) is implanted, the replacement valve may include a prosthetic attachment. The prosthesis may be configured to secure the replacement valve in the patient's heart. Additional details regarding prosthetic valves for mitral or tricuspid valve replacement may be found in: U.S. Patent Application No. 13 / 198,582, filed on August 4, 2011, entitled "Percutaneous Transcatheter Repair of Heart Valves"; U.S. Patent Application No. 13 / 397,545, filed on February 15, 2012, entitled "Percutaneous Transcatheter Repair of Heart Valves via Trans-Apical Access"; and U.S. Patent Application No. 13 / 779,478, filed on February 27, 2013, entitled "Percutaneous Annuloplasty System with Anterior-Posterior Adjustment," the contents of which are incorporated herein by reference in their entirety.

[0035] An implant and delivery system for introducing a semi-rigid ring to treat tricuspid or mitral regurgitation includes an annuloplasty ring comprising an outer hollow member having a plurality of segments. In another embodiment, the segments can be adjustable and can cooperate with each other to change the outer hollow member from an elongated insert molding geometry to an annular operable molding geometry. The tricuspid annuloplasty ring can include one or more zones including an internal anchoring member that is at least partially located within the outer hollow member. In a non-limiting embodiment, the tricuspid annuloplasty ring can include up to four different anchoring zones, which are further discussed herein. In one embodiment, the internal anchoring members can be configured to emerge sequentially from windows (i.e., openings) along the hollow tube, thereby potentially engaging tissue of the tricuspid annulus being treated in a predetermined sequence.

[0036] Systems and methods are provided for introducing an annuloplasty ring (e.g., when contained in a linear shape within a delivery system) in a transapical or transfemoral manner. In embodiments, the distal tip of the delivery system can be introduced above the annulus. Once the annuloplasty ring is introduced, the plane of the annuloplasty ring can be rotated (e.g., autorotated) to be parallel to the plane of the annulus. Once in the correct position, embodiments can deploy multiple anchors. For example, one embodiment can deploy anchors associated with the septal region, the posterior region, or the first anterior region or the second anterior region.

[0037] The annuloplasty ring can then be snapped into an appropriate shape (e.g., a "D" shape) and introduced into the stabilization tool. This shape is possible because, as discussed herein, the annuloplasty ring includes an outer hollow member having a plurality of segments, wherein the segments can be adjustable and can mate with each other to change the outer hollow member from an annular operable forming geometry to an elongated insert forming geometry, and vice versa.

[0038] Reference Figure 1 , shows a top view of an annuloplasty ring 100 associated with various embodiments discussed herein. As shown, the annuloplasty ring 100 can have an annular operable shaped geometry, wherein the first end and the second end are mechanically connected via a snap mechanism 130. In an embodiment, the annuloplasty ring can have an operable geometry. For example, the hypotube can be annular and / or D-shaped. Additionally, Figure 1 A plurality of anchors 120 are shown deployed through a plurality of anchor windows 140 of annuloplasty ring 100. Figure 1 As shown, the annuloplasty ring 100 may have at least one synthetic leaflet 200 that is in mechanical communication with the annuloplasty ring at multiple points on the inner surface of the annuloplasty ring 100. In some embodiments, the synthetic leaflet 200 may include a valve frame 400 having a proximal opening. The at least one synthetic leaflet may also include a synthetic leaflet material mechanically coupled to the valve frame, wherein the synthetic leaflet material is within the proximal opening. Figure 1 As depicted, at least one synthetic leaflet can include a plurality of leaflets, wherein the plurality of leaflets are mechanically coupled.

[0039] Annuloplasty rings can be made of various materials (e.g., shape memory hypotube (nickel titanium (Ni-Ti) superelastic alloy)) that are cut to form multiple segments. Figure 1 , a cutting pattern for laser machining of the annuloplasty ring 100 (eg, cutting of the anchor windows 140 through which the anchors 120 may be deployed) is shown.

[0040] In an embodiment, the valve frame 400 can be made of various materials, including but not limited to shape memory metals (e.g., Ni-Ti). The valve frame 400 can have a diameter in the range of about 0.01 inches to about 0.015 inches. The synthetic leaflet material 200 can be mechanically coupled to the valve frame 400 by sutures (e.g., surgical sutures 401). This configuration can allow at least one synthetic leaflet to move toward the surface of the annulus when the annuloplasty ring is deployed. The suture material can be a polytetrafluoroethylene (PTFE) suture or a polypropylene suture. Additional embodiments may include a synthetic leaflet material made of a polymer material (e.g., polyurethane or dried precardiac tissue).

[0041] Reference Figure 2, shows a top view of an annuloplasty ring 100 associated with various embodiments discussed herein. As shown, the annuloplasty ring 100 can have an elongated insert geometry with a first end opposing a second end. In some embodiments, the first end, the second end, or both can have a snap mechanism 130. In some embodiments, the annuloplasty ring 100 can have a coating 500 (e.g., a DACRON coating) on ​​an inner or outer surface of the annuloplasty ring 100. In other embodiments, the annuloplasty ring 100 can have at least one synthetic leaflet 200. As shown in FIG. Figure 2 As depicted, at least one synthetic leaflet can include a plurality of leaflets positioned at a first end or a second end of the annuloplasty ring.

[0042] Figure 3 A cross-sectional view of an annuloplasty ring showing the elongated insert geometry within a delivery catheter 600 is shown.

[0043] Figure 4 A side view of the distal end of a delivery catheter 600 is shown with the annuloplasty ring 100 and at least one synthetic leaflet 200 partially deployed from the distal end of the delivery catheter. Figure 4 Also shown is a pull wire 700 that may be in mechanical communication with the annuloplasty ring 100 .

[0044] FIG. 5A to FIG. 5C A perspective view of the annuloplasty ring 100 is depicted in which the plane of the annuloplasty ring 100 (in its annular operative geometry) has been changed to be perpendicular to the longitudinal axis of the delivery catheter 600. Figure 5A As shown, at least one synthetic leaflet 200 includes a plurality of leaflets that are mechanically connected. In some embodiments, the plurality of leaflets that are mechanically connected are configured to be operably connected to the inner surface of the posterior side 900 of the annuloplasty ring 100. In other embodiments, the plurality of leaflets that are mechanically connected are configured to be operably connected to the inner surface of the anterior side 1000 of the annuloplasty ring 100. Figure 5B As shown, in some embodiments, the annuloplasty ring 100 may include a ring element 1100 .

[0045] Figure 5C Another embodiment is depicted in which the annuloplasty ring 100 includes a plurality of leaflets having one or more band holes 210. The plurality of leaflets may be configured to be in mechanical communication using a suture band 220 that operably connects the plurality of leaflets through the one or more band holes 210. In further embodiments, the suture band 220 may be configured to pass through the snap mechanism 130 and into the delivery catheter 600.

[0046] Figure 6An annuloplasty ring 100 and a plurality of anchors 120 deployed are depicted, with at least one synthetic leaflet 200 angled toward the annulus and the native posterior leaflet.

[0047] Reference Figures 7 and 8 , shows an annuloplasty ring 100 associated with various embodiments discussed herein. As shown, the annular operable geometry ( Figure 7 ) or slender insert geometry ( Figure 8 ) may include a plurality of leaflets 200. In some embodiments, the inner surface of the posterior side of the annuloplasty ring 100 may include a plurality of leaflets having a band hole, the band hole providing mechanical communication for the plurality of leaflets. The plurality of leaflets may be in mechanical communication with the inner surface of the posterior side of the annuloplasty ring 100 at a plurality of points.

[0048] In another embodiment, Fig.12 As shown, the annuloplasty ring may include at least one synthetic leaflet on the inner surface of the posterior side of the annuloplasty ring 100. The at least one synthetic leaflet may be in mechanical communication with the inner surface of the posterior side of the annuloplasty ring 100 at multiple points. In addition, a snap mechanism 130 may be located on the anterior side of the annuloplasty ring 100.

[0049] In another embodiment, Fig.13 As shown, the inner surface of the posterior side of the annuloplasty ring 100 may include a plurality of leaflets with band holes that provide mechanical communication for the plurality of leaflets. The plurality of leaflets may be in mechanical communication with the inner surface of the posterior side of the annuloplasty ring 100 at a plurality of points. In addition, the inner surface of the anterior side of the annuloplasty ring 100 may include at least one synthetic leaflet 200 in mechanical communication with the inner surface of the annuloplasty ring 100. In some embodiments, as Fig.13 As depicted, the inner surface of the annuloplasty ring 100 may include a plurality of commissural leaflets 200a, 200b.

[0050] In some embodiments, such as Fig. 9 As shown, the leaflet anchor 800 can be in mechanical communication with at least one synthetic leaflet 200 of the annuloplasty ring 100. In some embodiments, the leaflet anchor 800 can mechanically couple one or more native leaflets to at least one synthetic leaflet 200. This embodiment can allow one or more synthetic leaflets 200 to cooperate, such as Fig.10 shown.

[0051] like FIG. 11A to FIG. 11CAs shown, the leaflet anchor 800 may have an anchor body 830 with a first end and a second end. The leaflet anchor 800 may also include an anchor portion 820 that is mechanically connected to the first end of the leaflet anchor. In other embodiments, the leaflet anchor 800 may also include a separation element 850 that is mechanically connected to the second end of the leaflet anchor. The separation element 850 may be configured to separate the anchor delivery catheter 835 and the leaflet anchor 800. The leaflet anchor 800 may also include a disc portion 840, wherein the disc portion is mechanically connected to the anchor body 830 between the first end and the second end. Fig. 11B As shown, leaflet anchor 800 can be configured to be deployed from delivery catheter 600, from anchor delivery catheter 835, or a combination thereof. In some embodiments, leaflet anchor 800 can be configured to pass through native leaflets 1200 and at least one synthetic leaflet 200, with anchor portion 820 deployed on a surface of at least one synthetic leaflet 200. In some embodiments, disc portion 840 can be configured to secure anchor portion 820 to at least one synthetic leaflet 200 and native leaflet 1200.

[0052] The annuloplasty rings described above can be designed and shaped for a variety of functions, such as mitral valve replacement. Similar annuloplasty rings can also be designed and constructed for tricuspid valve replacement. However, the tricuspid valve ring can be designed with additional features, such as a release zone positioned on the ring assembly at a location that will be adjacent to the patient's atrioventricular node or valve. In certain implementations, the release zone does not have any anchors. Instead, the alternative shape and contour of the release zone provides interference between the annuloplasty ring and the patient's atrioventricular node or valve, thereby securing the ring assembly in place.

[0053] Some embodiments are directed to methods of delivering an annuloplasty ring substantially as described above. In some embodiments, the annuloplasty ring may be delivered in an elongated insert geometry, wherein delivery of the annuloplasty ring utilizes one of a transapical approach, a transseptal approach, a transfemoral approach, a transjugular approach, or a transatrial approach.

[0054] The present disclosure is not limited to the specific devices, systems, apparatuses and methods described, as these may vary. The terminology used in the specification is for the purpose of describing specific versions or embodiments only and is not intended to limit the scope.

[0055] As used in this document, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Nothing in this disclosure should be construed as an admission that the embodiments described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention. As used in this document, the term "including" means "including, but not limited to."

[0056] In the above detailed description, reference is made to the accompanying drawings, which form a part thereof. In the drawings, similar symbols generally identify similar parts unless the context dictates otherwise. The exemplary embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be used, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the various features of the present disclosure, as generally described herein and as shown in the accompanying drawings, may be arranged, substituted, combined, separated, and designed into a variety of different configurations, all of which are expressly contemplated herein.

[0057] The present disclosure is not limited to the specific embodiments described in this application, which are intended to be illustrative of the various features. It will be apparent to those skilled in the art that many modifications and variations can be made without departing from the spirit and scope of the present invention. According to the foregoing description, in addition to those listed herein, functionally equivalent methods and devices within the scope of the present disclosure will be apparent to those skilled in the art. Such modifications and variations are intended to fall within the scope of the appended claims. The present disclosure is limited only by the terms of the appended claims and the full scope of equivalents of such claims. It should be understood that the present disclosure is not limited to specific methods, reagents, compounds, compositions or biological systems, which may of course be different. It should be understood that the terms used herein are only used for the purpose of describing specific embodiments and are not intended to be limited.

[0058] With respect to the use of substantially any plural and / or singular terms herein, those skilled in the art may translate from the plural to the singular and / or from the singular to the plural as is appropriate to the context and / or application. For purposes of clarity, the various singular / plural permutations may be expressly set forth herein.

[0059] It will be understood by those skilled in the art that, in general, the terms used herein, especially in the appended claims (e.g., the bodies of the appended claims), are generally intended to represent "open" terms (e.g., the term "including" should be interpreted as "including but not limited to", the term "having" should be interpreted as "having at least", the term "includes" should be interpreted as "including but not limited to", etc.). Although various compositions, methods, and apparatus are described in terms of "comprising" various components or steps (interpreted to mean "including but not limited to"), the compositions, methods, and apparatus may also "consist essentially of" or "consist of" the various components and steps, and such terms should be interpreted as limiting substantially closed groups of members. It will also be understood by those skilled in the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such a recitation, no such intent is present.

[0060] For example, to aid understanding, the following appended claims may contain the use of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be construed as implying that the introduction of a claim recitation by the indefinite article "a" or "an" limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim contains the introductory phrases "one or more" or "at least one" and an indefinite article such as "a" or "an" (e.g., "a" and / or "an" should be interpreted as meaning "at least one" or "one or more"); the same applies to the use of definite articles used to introduce claim recitations.

[0061] Furthermore, even if a specific number of an introduced claim recitation is explicitly recited, one skilled in the art will recognize that such recitation should be interpreted to mean at least the recited number (e.g., a bare recitation of "two recitations" without other modifiers means at least two recitations or two or more recitations). Furthermore, in those cases where a conventional expression similar to "at least one of A, B, and C, etc." is used, generally speaking, the meaning of such construction is that one skilled in the art will understand the conventional expression (e.g., "a system having at least one of A, B, and C" will include but is not limited to a system having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In those cases where conventional expressions similar to "at least one of A, B, or C, etc." are used, generally speaking, the meaning of such construction is that one skilled in the art will understand the conventional expression (e.g., "a system having at least one of A, B, or C" will include, but is not limited to, systems having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). One skilled in the art will also understand that, in fact, any discrete words and / or phrases presenting two or more alternative terms, whether in the specification, claims, or drawings, should be understood to contemplate the possibility of including one of the terms, either of the terms, or both of the terms. For example, the phrase "A or B" will be understood to include the possibility of "A" or "B" or "A and B."

[0062] In addition, where features of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group.

[0063] As will be understood by those skilled in the art, for any and all purposes, such as in terms of providing a written description, all ranges disclosed herein also encompass any and all possible sub-ranges and combinations of their sub-ranges. Any listed range can be easily identified as fully describing and enabling the same range to be divided into at least equal halves, thirds, quarters, fifths, tenths, etc. As a non-limiting example, each range discussed herein can be easily decomposed into a lower third, a middle third, and an upper third, etc. As will be understood by those skilled in the art, all languages ​​such as "at most", "at least", etc. contain the cited numbers and refer to the ranges that can be subsequently decomposed into sub-ranges as discussed above. Finally, as will be understood by those skilled in the art, the range includes each individual member. Therefore, for example, a group with 1-3 units refers to a group with 1, 2, or 3 units. Similarly, a group with 1-5 units refers to a group with 1, 2, 3, 4, or 5 units, etc.

[0064] The various features and functions disclosed above and other features and functions or their alternatives may be combined into many other different devices or applications. Those skilled in the art may subsequently make various currently unforeseen or unanticipated alternatives, modifications, variations or improvements therein, each of which is also intended to be covered by the embodiments disclosed herein.

Claims

1. A valve annuloplasty device, comprising: an annuloplasty ring comprising a first end and a second end opposite the first end, the annuloplasty ring being configured to transition between an elongated insert geometry and an annular operable geometry; a plurality of anchors disposed within the annuloplasty ring, the plurality of anchors being configured to assume an expanded configuration when the annuloplasty ring is in the annular operable geometry; and at least one synthetic leaflet in mechanical communication with the annuloplasty ring at a plurality of points and directly mechanically connected to the annuloplasty ring, wherein the at least one synthetic leaflet comprises a plurality of leaflets, and the plurality of leaflets comprises a first leaflet positioned adjacent to the first end of the annuloplasty ring and a second leaflet positioned adjacent to the second end of the annuloplasty ring.

2. The annuloplasty device of claim 1 , wherein the at least one synthetic leaflet comprises: a valve frame comprising a proximal opening; and A synthetic leaflet material is mechanically coupled to the valve frame, wherein the synthetic leaflet material is disposed within the proximal opening.

3. The annuloplasty device of claim 2, wherein the valve frame comprises a shape memory metal.

4. The annuloplasty device of claim 2, wherein the synthetic leaflet material comprises a polymer material.

5. The annuloplasty device of claim 1, wherein at least a portion of each of the first leaflet and the second leaflet are mechanically coupled.

6. The annuloplasty device of claim 1, wherein the at least one synthetic leaflet is in mechanical communication with the annuloplasty ring at a plurality of points posterior to the native valve.

7. The annuloplasty device of claim 1, wherein the at least one synthetic leaflet is in mechanical communication with the annuloplasty ring at a plurality of points anterior to the native valve.

8. The annuloplasty device of claim 1, wherein the annuloplasty ring further comprises a plurality of anchor windows through which the plurality of anchors can be deployed.

9. The annuloplasty device of claim 1, wherein the annuloplasty ring comprises a coating.

10. The annuloplasty device of claim 9, wherein the coating comprises a polyethylene terephthalate coating.

11. The annuloplasty device of claim 1 , wherein the annuloplasty ring comprises a shape memory metal.

12. The annuloplasty device of claim 1, wherein the at least one synthetic leaflet comprises one or more cinching holes configured to receive a suture therethrough.

13. The annuloplasty device of claim 1, wherein the annuloplasty ring further comprises at least one snap mechanism configured to connect the first end and the second end.

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