Valve repair device with coaptation structure and multiple leaflet capture clips - Patents.com

Abstract

A heart valve repair device including a coaptation member and multiple clip mechanisms, as well as related systems and methods, are disclosed herein. A heart valve repair device configured in accordance with embodiments of the present technology may include, for example, an optional fixation member configured to engage tissue within the left atrium near the native mitral valve, a coaptation member depending from the fixation member, and multiple clip mechanisms extending from a downstream portion of the coaptation member. The coaptation members are positionable between the native cusps and can at least partially fill the space between the cusps. A first clip mechanism can engage a first portion of one of the native cusps, and a second clip mechanism can engage another portion of the same native cusp or the opposite native cusp.

Description

[Technical field]

[0001] The present technology relates to devices, systems, and methods for heart valve repair, and in particular to valve repair devices with coaptation structures and multiple leaflet capture clips.

[0002] REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 902,694, filed September 19, 2019, the entire disclosure of which is incorporated herein by reference. [Background technology]

[0003] Proper function of the mitral valve may be compromised by mitral regurgitation, mitral valve prolapse, and mitral valve stenosis. Mitral regurgitation may occur when the leaflets of the mitral valve do not coapt and stick together at peak systolic pressure, resulting in blood leaking from the left ventricle into the left atrium. There are several structural factors that may impair proper closure of the mitral valve leaflets. For example, enlargement of the mitral valve annulus caused by myocardial dilation may prevent the leaflets from coapting properly during systole. Other disorders include stretching or avulsion of the chordae tendineae - the tendons that connect the papillary muscles to the underside of the mitral valve leaflets - which also impairs proper closure of the mitral valve annulus. For example, rupture of the chordae tendineae may allow the leaflets to prolapse into the left atrium due to inappropriate tension on the leaflets. Abnormal regurgitation can also occur when papillary muscle function is impaired (eg, due to ischemia), such that the affected papillary muscle does not contract sufficiently during systole to effect proper closure.

[0004] Mitral valve prolapse can occur when the mitral valve leaflets bulge abnormally upward into the left atrium, which can also result in mitral regurgitation. Normal function of the mitral valve can also be compromised by mitral stenosis, or narrowing of the mitral orifice, which prevents filling of the left ventricle during diastole.

[0005] Mitral regurgitation is often treated with diuretics and / or vasodilators to reduce the amount of blood that backs up into the left atrium. Other treatments, such as surgical approaches (open and endovascular), have also been used to either repair or replace the mitral valve. For example, cinching or resection of portions of the dilated annulus are typical repair techniques. Cinching of the annulus has generally been achieved by implantation of annular or circumferential annular rings that are fixed to the annulus or surrounding tissue. Other repair techniques have also involved suturing or clipping the leaflets into their mutual attachments. Alternatively, in more invasive procedures, the entire valve is replaced with a mechanical valve or biological tissue. These invasive procedures have traditionally been performed through a large open thoracotomy, and thus are extremely painful, have significant morbidity, and require long recovery periods.

[0006] However, many repair and replacement procedures can experience complications due to durability of the devices or improper sizing of the annuloplasty ring or replacement valve. Additionally, many repair procedures are dependent on the skill of the cardiac surgeon, as poorly or incorrectly placed sutures can adversely affect the success of the procedure.

[0007] Compared to other heart valves, the mitral valve poses unique challenges because some portions of the mitral valve annulus limit significant radial support from the surrounding tissues and the mitral valve has an irregular and unpredictable shape. For example, the anterior wall of the mitral valve is bounded only by a thin wall that separates the mitral valve annulus from the lower portion of the aortic outflow tract. As a result, significant radial forces on the mitral valve annulus cannot be tolerated because such forces may lead to collapse of the lower portion of the aortic tract, with potentially fatal consequences. Another challenge with the mitral valve as an anatomical structure is the labyrinthine chordae tendineae in the left ventricle, making it extremely difficult to navigate and position a deployment catheter compared to other heart valves. Given the challenges and shortcomings associated with current procedures, there remains a need for simple, effective, and minimally invasive devices and methods for treating dysfunctional heart valves. Summary of the Invention

[0008] According to one aspect of the present invention, there is provided a valve repair device comprising: an atrial fixation member configured to press against cardiac tissue proximate the native valve annulus; an atrial fixation member extending radially inward away from and from the atrial fixation member, the atrial fixation member having an inner portion having an abutment surface configured to abut with the first native cusp during cardiac systole, an outer portion configured to displace at least a portion of the second native cusp, and a downstream end portion, the abutment member being substantially stationary during the cardiac cycle; A valve repair device is provided having a plurality of clip mechanisms depending from an attachment member, each clip mechanism including a base portion coupled to a downstream end portion of the attachment member, a free end portion not attached to the attachment member, and an articulatable arm member extending in an upstream direction from the base portion and forming the free end portion, the articulatable arm member configured to capture a portion of either a first native cusp or a second native cusp located between the articulatable arm member and the attachment member.

[0009] According to another aspect of the present invention, there is provided a valve repair device comprising: a coaptation member configured to be positioned between a posterior leaflet and an anterior leaflet of the mitral valve, the coaptation member comprising: A frame structure including a plurality of struts; a cover configured to extend along at least a portion of the frame structure to form an enclosed chamber within the frame structure; an anterior portion comprising a surface configured to displace or coapt the anterior leaflet during systole; and a posterior portion configured to displace or interface with at least a portion of the posterior leaflet; the joint member is substantially stationary during the cardiac cycle; a plurality of clip mechanisms depending from the joining member, one or more of the clip mechanisms comprising: a base portion coupled to the joining member; A valve repair instrument is provided that includes an articulatable arm member extending in an upstream direction from a base portion, the articulatable arm member having a free end portion not attached to an articulation member, the articulatable arm member configured to capture a portion of a posterior leaflet or anterior leaflet located between the articulatable arm member and the articulation member.

[0010] According to another aspect of the invention, there is provided a method of repairing a heart valve, comprising the steps of: deploying a coaptation member of the valve repair device in the regurgitant valve orifice between the first native cusp and the second native cusp, the coaptation member having a first portion facing the first native cusp and a second portion facing the second native cusp, the coaptation member defining an open cavity separating the first portion and the second portion from one another; extending a first articulatable arm of a first clip mechanism behind a central portion of the first natural cusp such that the central portion of the first natural cusp is positioned between the first articulatable arm and a first portion of the joint member; actuating the first articulatable arm such that the first articulatable arm moves to achieve a closed condition in which the first articulatable arm compresses the first natural cusp between the first articulatable arm and the first portion; extending a second articulatable arm of a second clip mechanism behind either an outer portion of the first natural cusp or a central portion of the second natural cusp; The method includes actuating the second articulatable arm to cause the second articulatable arm to move to a closed position in which the second articulatable arm presses against the cusp portion.

[0011] Many aspects of the present disclosure can be better understood with reference to the following drawings. The components illustrated in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure. [Brief description of the drawings]

[0012] [Figure 1A] 1 is a plan view of a valve repair device constructed in accordance with an embodiment of the present technology. [Figure 1B] 1 is a side view of a valve repair device constructed in accordance with an embodiment of the present technology. [Figure 1C] 1C is a side cross-sectional view of the valve repair device of FIGS. 1A and 1B implanted at the mitral valve in accordance with an embodiment of the present technology. FIG. [Figure 1D] FIG. 1D is a cross-sectional view of a valve repair device according to the embodiment of the present technology of FIGS. 1A-1C during diastole. [Figure 1E] 1A-1C during cardiac systole. FIG. 1C is a cross-sectional view of a valve repair device according to the embodiment of the present technology. [Figure 2A] 1 is a side cross-sectional view of a valve repair device implanted at the mitral valve in accordance with an embodiment of the present technology. [Figure 2B] FIG. 2B is a side cross-sectional view of a valve repair device according to an embodiment of the present technology of FIG. 2A during diastole. [Figure 2C] 2B is a side cross-sectional view of a valve repair device according to an embodiment of the present technology of FIG. 2A during systole. [Figure 3A] 1 is a side cross-sectional view of a valve repair device implanted at the mitral valve during diastole in accordance with an embodiment of the present technology. [Figure 3B] 1 is a side cross-sectional view of a valve repair device implanted at the mitral valve during cardiac systole in accordance with an embodiment of the present technology. [Figure 4] 1 is a side cross-sectional view of a valve repair device with a low profile fixation member implanted at the mitral valve in accordance with an embodiment of the present technology. [Figure 5A] 1 is a front view of a valve repair device including a posterior fixation member constructed in accordance with an embodiment of the present technology. [Figure 5B]1 is a side view of a valve repair device including a posterior fixation member constructed in accordance with an embodiment of the present technology. [Figure 6] 1 is a side cross-sectional view of a valve repair device with a posterior fixation member implanted at the mitral valve in accordance with an embodiment of the present technology. [Figure 7] 1 is a side cross-sectional view of a valve repair device with an anterior fixation member implanted at the mitral valve in accordance with an embodiment of the present technology. [Figure 8] 1 is a side cross-sectional view of a valve repair device implanted at the mitral valve in accordance with an embodiment of the present technology. [Figure 9A] 1 is a side cross-sectional view of a valve repair device shown prior to independent clip engagement in accordance with an embodiment of the present technology. [Figure 9B] 1 is a side cross-sectional view of a valve repair device shown after independent clip engagement in accordance with an embodiment of the present technology. [Figure 10] 1 is a side cross-sectional view of a valve repair device implanted at the mitral valve in accordance with an embodiment of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The present technology relates to a heart valve repair device with a coaptation structure and multiple clip mechanisms, and related systems and methods. In some embodiments, for example, a heart valve repair device (also referred to herein as a "mitral valve repair device", "coaptation assist device", "implant device", and other terms used interchangeably) includes (i) a coaptation member (also referred to herein as an "coaptation structure", "baffle", "body", "intravalve body", "intermediate structure", and other terms used interchangeably) positioned between the native valve leaflets, and (ii) two or more clip mechanisms (also referred to herein as "clips", "capturing clips", "capturing mechanisms", and other terms used interchangeably) that secure the coaptation member to one or more native leaflets (e.g., the posterior and / or anterior leaflets of the mitral valve). The coaptation member may be coupled to a fixation member (also referred to herein as a "brim", "anchor structure", "atrial fixation member", and other terms used interchangeably) that anchors to cardiac tissue within the atrium and / or provides a platform for ingrowth to hold the coaptation member in place.

[0014] The coaptation member at least partially fills the regurgitant orifice of a leaking heart valve (e.g., mitral valve) and provides a new coaptation surface for the natural leaflets to seal around. The coaptation member may push a portion of the natural leaflets (e.g., the P2 segment of the posterior leaflet of the natural mitral valve) open toward the ventricular wall while reducing or minimizing cracking of the remaining natural leaflets. In various embodiments, the cross section (i.e., plan view) of the coaptation member may have an asymmetric crescent shape that matches the natural shape of the coaptation line of the mitral valve. In some embodiments, the coaptation member has other asymmetric shapes that may correspond to the natural coaptation lines of other valves or portions thereof. This shape is expected to provide more efficient leakage reduction than symmetric coaptation members and may also reduce the need to implant multiple separate clipping devices for proper coaptation that is common in other clip procedures that lack coaptation members (e.g., procedures using Mitraclip, Abbott Laboratories, Abbott Park, Illinois). For example, in the Mitraclip degeneration MR studies (EVEREST II and REALISM), 54% of patients who received clips received 2 or more clips (maximum 2), whereas in the functional MR study (COAPT), 64% of 288 patients received 2 or more clips (maximum 4).

[0015] Once the coaptation member is implanted at the mitral valve, it may be rotationally oriented and stabilized at the central portion of the posterior leaflet (i.e., P2) via a secondary annular clip (also referred to as the "primary clip," "first clip mechanism," or "posterior clip") that passes through a chordae-free zone near the center of the posterior leaflet (P2) and below the native leaflet. The valve repair device may have one or more additional clips that are secured to different portions of the same leaflet as the primary clip, such as the lateral portion (P1) and / or medial portion (P3) of the posterior leaflet, and / or secured to other leaflets, such as the anterior leaflet. For example, a secondary clip (such secondary clip may be referred to as the "anterior clip," "second clip mechanism," or "A2 clip") may be deployed to secure the coaptation member to the native anterior leaflet. The anterior clip may be shorter than the primary clip to avoid it extending to the aortic valve and potentially impairing its function. Alternatively or additionally, in addition to the anterior clip embodiment described above, the valve repair device may include a clip (e.g., a secondary or tertiary clip) that is rotationally oriented relative to the coaptation member so that the clip can be deployed at other portions of the posterior leaflet (e.g., P1 or P3) rather than the anterior leaflet, depending on the shape, size, and location of the regurgitant ostium.

[0016] The fixation members may be positioned and deployed in the atrium after the coaptation members and clips have been deployed. In some embodiments, the fixation members are deployed prior to one or more of the coaptation members and / or clips. The fixation members secure and stabilize the coaptation members and provide a platform for tissue ingrowth. The additional stability provided by the fixation members may reduce or eliminate the need to attach frictional elements to the clips, thereby reducing or minimizing impact on the native leaflets during clip deployment and positioning. Additionally, the ingrowth fixation members may provide an "annuloplasty" effect, limiting further dilation of the mitral annulus due to incorporation of fibrous tissue.

[0017] Specific details of some embodiments of the technology are described below with reference to Figures 1A-10. Although many of the embodiments are described below with reference to implant devices, systems, and methods for repair of native mitral valves, in addition to those fields and embodiments described herein, other fields and other embodiments are within the scope of the technology. For example, the technology can be used at other target sites, such as tricuspid, pulmonary, and / or aortic valves. In addition, some other embodiments of the technology can have different configurations, components, or procedures than those described herein, and features of the illustrated embodiments can be combined with each other. Thus, as will be appreciated by those skilled in the art, the technology can be practiced in other embodiments with additional elements, or the technology can be practiced in other embodiments in which some of the features illustrated in and described below with reference to Figures 1A-10 are omitted. In some cases, well-known structures and techniques often associated with cardiac implants and prosthetic heart valves are not shown in detail so as not to obscure the technology. The terms used in the description provided below are intended to be interpreted in their broadest reasonable manner, even when used in connection with a detailed description of certain embodiments of the present disclosure.

[0018] The accompanying figures illustrate embodiments of the present technology, but are not intended to limit its scope. Sizes of various elements shown in the figures are not necessarily drawn to scale and may be arbitrarily enlarged to improve legibility of the various elements. Details of components may be abstracted in the drawings to omit details such as the location of components or certain precise connection manners between such components when such details are not necessary for a complete understanding of how to construct and use the technology. Many of the details, dimensions, angles, and other features shown are merely illustrative of certain embodiments of the present disclosure. Thus, other embodiments may have other details, dimensions, angles, and other features without departing from the spirit or scope of the technology.

[0019] With respect to the terms "distal" and "proximal" that appear in this description, unless otherwise specified, these terms may describe the relative positions of portions of the catheter subsystem with respect to the operator and / or location in the vasculature. Additionally, terms such as "rear," "forward," "upper," "lower," etc., used herein do not limit the referenced components to use in a particular orientation. As will be understood, such terms relate to the orientation of the referenced components as shown in the drawings, and the systems of the present technology can be used in any orientation suitable to the user.

[0020] With respect to the terms "distal" and "proximal" that appear in this description, unless otherwise specified, these terms may describe the relative location of portions of a valve repair device and / or associated delivery device with respect to an operator and / or a location in the vasculature or heart. For example, when referring to a delivery catheter suitable for carrying and positioning the various valve repair devices described herein, "proximal" may refer to a location of the device closer to the operator or incision, and "distal" may refer to a location that is further from the operator of the device or further along the vasculature from the incision (e.g., the end of the catheter). With respect to a heart valve repair device, "proximal" and "distal" may refer to portions of the device relative to the native valve annulus. For example, "proximal" may refer to an upstream portion of the device spaced from the native valve annulus, and "distal" may refer to a downstream location at or near the native valve annulus.

[0021] Additionally, terms such as "front," "rear," "upper," "lower," "top," "bottom," and the like, used herein are not intended to limit the described components to use in a particular orientation. As will be understood, such terms refer to the orientation of the described components as shown in the figures. However, the systems of the present technology can be used in any orientation suitable for a user.

[0022] The headings provided herein are for convenience only and are not to be construed as limiting the scope of the invention disclosed.

[0023] Selected Embodiments of Valve Repair Devices 1A and 1B are plan and side views, respectively, of a valve repair device 100 ("device 100") that may be implanted within the heart of a subject (e.g., a human patient) in accordance with an embodiment of the present technology. FIGS. 1C-1E are side and cross-sectional views of the device 100 of FIGS. 1A and 1B implanted at the mitral valve in accordance with an embodiment of the present technology. Referring together to FIGS. 1A and 1B, device 100 may include a fixation member 102, a coaptation member 104 extending in a downstream direction from fixation member 102, and a number of clip mechanisms (individually referred to as first clip mechanism 116a and second clip mechanism 116b, and collectively referred to as "clip mechanisms 116") depending from coaptation member 104. The fixation member 102 is sized and shaped to secure the device 100 to cardiac tissue (e.g., atrial tissue) located near or upstream of the native valve annulus, and the fixation member positions the coaptation member 104 between the native leaflets at a desired location with respect to the native valve anatomy of the heart. The coaptation member 104 has a volume that fills at least a portion of the regurgitant ostium between the native leaflets, can displace at least a portion of one or more of the native leaflets, and provides an artificial coaptation surface for at least a portion of one or more of the native leaflets of the heart valve. For example, as shown in Figures 1C-1E, when the device 100 is deployed across the mitral valve annulus, the coaptation member 104 can be positioned at a location that extends in front of a central portion of the posterior leaflet PL (i.e., P2 of the posterior leaflet PL) to allow the coaptation member to coapt with the anterior leaflet AL during systole (Figure 1E). The clip mechanism 116 is configured to extend behind one or more natural cusps and grasp some portion of such natural cusp to attach the one or more cusps to the joint member 104 .

[0024] 1A and 1B, device 100 is configured with respect to a flow axis VA (FIG. 1B) in the direction of blood flow from the atrium to the ventricle, and with respect to a lateral axis HA (FIG. 1A) that is angled (e.g., perpendicular) to flow axis VA. Device 100 has a first side P (e.g., a posterior side), a second side A (e.g., an anterior side) opposite first side P, a top end portion S (e.g., a first end portion), and a bottom end portion I (e.g., a second end portion) opposite top end portion S.

[0025] In some embodiments, the device 100 may be adapted for use with any of the devices disclosed in any of the following applications: (i) U.S. application Ser. No. 16 / 044,447, filed July 24, 2018, entitled "PROSTHETIC LEAFLET DEVICE," (ii) International application PCT / US2018 / 061126, filed November 14, 2018, entitled "LEAFLET EXTENSION FOR CARDIAC VALVE LEAFLET," (iii) U.S. application Ser. No. 16 / 745,246, filed January 16, 2020, entitled "IMPLANTABLE COAPTATION ASSIST DEVICES WITH SENSORS AND ASSOCIATED SYSTEMS AND METHODS," and / or (iv) U.S. application Ser. No. 16 / 817,464, filed March 12, 2020, entitled "CARDIAC VALVE REPAIR DEVICES," (v) U.S. application Ser. No. 16 / 10,333, filed May 19, 2020, entitled "CARDIAC VALVE REPAIR DEVICES," (vi) U.S. application Ser. No. 16 / 2020, entitled "CARDIAC VALVE REPAIR DEVICES," (vi) U.S. application Ser. The implantable devices may have several features that are generally similar or identical to the implantable devices described in US Pat. No. 6,393,366, and US Pat. No. 6,393,366, and US Pat. No. 6,393,366, and US Pat. No. 6,393,366, each of which is incorporated by reference herein in its entirety. Any of the valve repair devices disclosed herein may be delivered to the heart valve transvascularly (e.g., transseptal delivery via the femoral or axillary veins), percutaneously (e.g., transapically), and / or surgically.

[0026] The fixation member 102 may be made of a mesh, e.g., a braided or laser cut stent-like structure, and / or other type of frame including a plurality of interconnected wires or struts 106 that together form a plurality of openings or cells 108 (e.g., diamond-shaped openings) arranged in one or more rows. The struts 106 may be configured to self-expand from a collapsed delivery state (not shown) to an expanded deployed state shown in FIGS. 1A and 1B. The struts 106 may be made of any biocompatible material, e.g., stainless steel, nickel-titanium alloy (e.g., Nitinol), and / or other suitable stent material. In the delivery state, the fixation member 102 may have a generally circular, oval, or D-shaped shape with an open central lumen 110 (also referred to as "opening 110") that allows blood to flow therethrough along a flow axis VA. When the device 100 is configured to repair a native mitral valve, the fixation member 102 may be shaped to conform to the wall of the left atrium just above the mitral annulus to secure the device 100 to supranulular tissue. After a period of time (e.g., 3 days, 2 weeks, 1 month, 2 months) after implantation, the fixation member 102, or a portion of the fixation member, becomes covered with a layer of tissue, and this tissue ingrowth permanently attaches the device 100 to the atrial wall. As described in more detail below, in some embodiments, the fixation member 102 has a semicircular or other shape that does not extend completely around the circumference of the native valve. In some embodiments, the fixation member 102 may additionally or alternatively include one or more portions that extend into the annulus and / or press against subannular tissue to enable fixation of the device below the annulus.

[0027] As shown in FIG. 1B, in some embodiments, the fixation members 102 have additional friction elements 122 that project outwardly from the fixation members 102 together and are configured to promote anchoring and / or stimulate tissue ingrowth. The friction elements 122 can be teeth, barbs, prongs, screws, hooks, corrugations, and / or other features or structures that promote tissue engagement. In the illustrated embodiment, for example, the friction elements 122 include two prongs that extend outwardly in a downstream direction from a lower portion of the fixation members such that the prongs can project into tissue near the annulus. In other embodiments, the fixation members 102 can include additional and / or different friction elements 122.

[0028] 1A and 1B, the coaptation member 104 extends away from the downstream portion of the fixation member 102 along the flow axis VA, and at least a portion of the coaptation member 104 extends radially inward from the fixation member 102 into the central lumen 110 to fill a portion of the native valve orifice. In the illustrated embodiment, the coaptation member 104 is angled or tilted outward (e.g., backward) from the central valve axis to push a portion of the adjacent native leaflet back from the valve opening to approximate the closed position of the native leaflet. In some embodiments, the coaptation member 104 is more centrally located within the valve orifice. The coaptation member 104 may be substantially stationary (e.g., may have little or no movement) during the cardiac cycle, such that the position of the coaptation member 104 relative to the fixation member 102 is at least substantially fixed in the deployed state. Thus, unlike the natural leaflets which move back and forth to open and close the natural valve, the coaptation members 104 remain stationary during diastole and systole. In some embodiments, the coaptation members 104 undergo some movement during the cardiac cycle, but not to the same extent as the natural leaflets.

[0029] The coaptation member 104 has an inner portion 112 (see FIG. 1B , also referred to as the “first portion,” “front portion,” “side,” or “surface”) facing the central axis of the valve and toward one or more opposing leaflets, an outer portion 114 (see FIG. 1B , also referred to as the “second portion,” “rear portion,” “side,” or “surface”) facing away from the central axis of the valve, a downstream end portion 107 (also referred to as the “bottom portion,” or “lower portion”), and an upstream end portion 109 (also referred to as the “top portion,” “cap,” or “upper portion”). The inner portion 112 can have a smooth, atraumatic surface 113 (also referred to as the “coaptation surface”) that coapts with at least a portion of one or more opposing natural leaflets, and the outer portion 114 can displace and engage at least a portion of another natural leaflet. In some embodiments, the inner portion 112 and / or the outer portion 114 can include friction elements that engage the natural cusps.

[0030] The joining member 104 comprises an expandable frame structure 101 (e.g., a mesh structure, a laser cut stent frame) made of a plurality of interconnected struts (e.g., similar to the struts 106 of the fixation member 102) that define an at least partially hollow interior space when the device 100 is in the deployed state. In some embodiments, for example, the frame structure 101 can comprise interconnected struts (e.g., elongated struts or mesh-like structures) extending along the inner portion 112 and the outer portion 114, and elongated struts extending along the downstream end portion 107 and the upstream end portion 109. Some portions of the frame structure 101 can be decoupled (e.g., at the downstream end portion 107) to allow some portions of the struts to slide over each other and / or move apart from each other to facilitate achieving a low profile and / or adjustability of the dimensional shape of the joining member 104 in the delivery state. The joining member 104, or portions thereof, can be integral with the fixation member 102. For example, the struts 106 of the stationary member 102 may extend in a downstream direction to form part of the frame structure 101. In other embodiments, the joining member 104 is a separate structure that is connected to portions of the stationary member 102 during manufacture using welding, adhesives, connectors, and / or other suitable connection mechanisms.

[0031] A covering 103 (e.g., fabric, graft material) can extend over at least a portion of the framework 101 to at least partially surround the framework 101 and provide a smooth, atraumatic surface for contacting or interfacing with the imposed natural cusp. In some embodiments, the covering 103 can include a padded portion (e.g., biocompatible foam) and / or the biocompatible foam can be attached to the framework 101. The covering 103 can extend over the struts along and between the inner and outer portions 112, 114 of the joint member 104 in a manner that forms lateral sidewalls. In some embodiments, the covering 103 can also extend between the inner and outer portions 112, 114 along the downstream end portion 107 and / or the upstream end portion 109 such that the framework 101 and the covering 103 together form a sealed cavity. The cover 103 can be provided with one or more access openings 105, such as slits, valves, or holes, that allow access to the interior of the frame structure 101 and the components therein during transport and / or retrieval. For example, the openings 105 can provide access to a delivery system connector that allows operation of a clip actuation mechanism that opens and closes the attachment members and / or clip mechanism 116. Additionally, cavities in the attachment members 104 can accommodate extension members, supplemental clips, and / or other components that can be optionally deployed during the implant procedure.

[0032] The configuration of the junction member 104, and in particular the stent-like structure of the frame 101, lends itself to adjustment of the junction member size and shape, as compared to other clipping devices, with or without fillers. In some embodiments, the junction member 104 may be adjustable in width (along the transverse axis HA) and / or projection depth (the extent to which the junction member fills the valve orifice). This adjustability is made possible with an insertable or removable element, such as an axial rod, inserted into the body of the junction member 104, which expands or contracts the stent structure of the junction member 104 during insertion / removal. In some embodiments, the junction member 104 is segmented to have partial or complete sections that are inflatable and / or passively expand to fill the reflux field. Suitable baffle structures, including adjustable baffles, are described in International Application No. PCT / US2018 / 043566, filed July 24, 2018, and International Application No. PCT / US2018 / 061126, filed November 14, 2018.

[0033] The clip mechanism 116 extends from the inner portion 112 and / or the outer portion 114 of the joining member 104 such that the clip mechanism 116 can extend behind and capture natural cusps positioned on one or both sides of the joining member 104. The clip mechanism 116 includes a base portion 120a (also referred to as a "first portion") attached to the joining member 104, a free end portion 120b (also referred to as a "second portion") not attached to the joining member 104, and an articulatable arm member 118 extending from the base portion 120a to form the free end portion 120b. The base portion 120a may be attached (e.g., to the frame structure 101 and / or associated cover 103) at the downstream end portion 107 of the joining member 104 by welding, adhesive, stitching, and / or other attachment mechanisms. In some embodiments, the base portion 120a extends from the downstream end portion 107 in an upstream direction (i.e., toward the flow axis VA) along the inside or outside of the junction member 104 (depending on where the clip is located) to provide additional fixation to the junction member 104 and / or additional torque to actuate the arm member 118. The arm 118 may extend from the base portion 120a in an upstream direction (i.e., toward the fixed member 102) along the length of the junction member 104. For example, the arm member 118 may only extend part way up along the junction member 104 and along the length of the junction member 104 to the downstream end of the fixed member 102. The arm 118 may form an inverted U-shape and may flare outwardly to form a wide section where the arm 118 presses against the natural cusp. In other embodiments, the arm members 118 may have other suitable shapes for engaging the leaflets and / or may have extensions at their distal-most ends for engaging subannular tissue for additional subannular stabilization and fixation.

[0034] The arm members 118 can be made of one or more wires, struts, and / or other semi-rigid / rigid structures with sufficient stiffness to clamp onto the cusps and / or subannular tissue. In some embodiments, the arm members 118 have a fabric covering, biocompatible foam or other type of padding and / or coating applied to the rigid members to provide a smooth surface to reduce trauma to the cusps and / or surrounding tissue, additional surface area for cusp engagement, and / or a platform for tissue ingrowth. In some embodiments, the arm members 118 and / or other portions of the clip mechanism 116 can include a number of spikes, teeth, corrugations, or other frictional features to promote stability and fixation onto the natural cusps.

[0035] The clip mechanism 116 may further include an actuation mechanism 121, e.g., a spring-loaded lever, that acts on the arm member 118 to move it between a closed position (shown in FIGS. 1A-1E, also referred to as the “closed state”, “closed configuration”, or “first state”) and an open position (also referred to as the “open state”, “open configuration”, or “second state”). In the closed state, the arm member 118 is positioned near or against a surface of the abutment member 104 with at least a portion of the arm member 118 pressed against the inner surface of the abutment member 104 to provide cusp engagement. In the open state, the articulatable arm member 118 extends away from the abutment member 104 (e.g., forming a V- or L-shape with surface portion 112 or 114) such that a free end portion 120b extends behind the natural cusp and can receive the natural cusp between the arm member 118 and the surface of the abutment member 104. In some embodiments, the actuation mechanism 121 holds the clip mechanism 116 in a normally closed state (e.g., due to a spring force) such that the clip mechanism 116 is in a closed state during instrument delivery and manipulation (e.g., pulling on a tendon) of the actuation mechanism 121, which moves the clip mechanism 116 to an open state. In other embodiments, the clip mechanism 116 is normally disposed in an open state.

[0036] The actuation mechanism 121 may be a spring-loaded lever (e.g., nitinol wire, laser cut nitinol, or Co-Cr sheet) operably coupled to a portion of the delivery system (not shown) that can be manipulated to move the clip mechanism 116 between the open and closed positions. For example, a tendon (made of suture or nitinol wire) may be attached to the spring-loaded lever and may extend beside or through the body of the joint member 104 (through opening 105 (FIG. 1A)) and through the delivery catheter to the outer handle assembly. The clinician may pull or otherwise apply tension to the tendon, which transfers the force to the lever, thereby moving the arm member 118 between the closed and open positions. In other embodiments, the actuation mechanism 121 can include different actuation means, such as other springs, clamps, pulleys, interfacing threaded members, and / or other actuation mechanisms as described in International Application PCT / US2018 / 061126, filed November 14, 2018. Furthermore, because each clip mechanism 116 includes its own actuation mechanism 121, the clip mechanisms 116 can be actuated independently.

[0037] In the illustrated embodiment, a first clip mechanism 116a depends from the outer portion 114 of the coaptation member 104 and a second clip mechanism 116b depends from the inner portion 112 of the coaptation member 104 such that the two clip mechanisms 116 engage portions of opposing natural cusps. For example, the first clip mechanism 116a can reach under and grasp a central portion of the posterior leaflet PL (i.e., P2) when in the mitral valve (e.g., as shown in FIGS. 1C-1E), and the second clip mechanism 116b can reach under and grasp a central portion of the atrial cusp AL (i.e., A2). In some embodiments, the device 100 can have more than two clip mechanisms 116 and / or omit one of the clip mechanisms 116. In some embodiments, for example, the device 100 has an additional clip mechanism 116 located on the same side as the first clip mechanism 116a and / or on the same side as the second clip mechanism 116b to engage a portion spaced outwardly of the same natural cusp.

[0038] During a delivery procedure at the mitral valve, the device 100 may be placed in a compacted delivery state in a delivery catheter (not shown) and inserted into the vascular system (e.g., via the femoral vein) and traversed the inferior vena cava to the right atrium. The device 100 may then be inserted into the left atrium via a puncture in the intraatrial septum. The device 100 may be appropriately oriented relative to the flow axis VA (FIG. 1B) and the lateral axis (FIG. 1A), and may be rotationally and angularly oriented relative to specific landmarks. For example, the device 100 may be oriented to align the clip mechanism 116 with a desired portion of the natural leaflet. In some embodiments, the device 100 may also be repositioned during the delivery process, for example to correct misalignment or improper positioning. During deployment and release of the device 100, the delivery system may hold the device 100 in a desired orientation and location within the valve annulus. Additionally, the delivery system can be configured to allow device 100 to be resheathed, repositioned, and / or withdrawn and then completely expelled from the delivery system. In some embodiments, device 100 can be configured to be delivered through a delivery catheter having a small overall diameter, for example, about 15-30 French.

[0039] 1C-1E, once the device 100 is properly oriented within the orifice between the anterior leaflet AL and the posterior leaflet PL, the device 100 can be deployed from a delivery catheter. For example, deployment can begin by expanding the coaptation member 104 to fill at least a portion of the orifice. As shown in FIG. 1C, in some embodiments, the expansion of the coaptation member 104 displaces at least a portion of the posterior leaflet PL. The clip mechanisms 116 can then be selectively actuated to engage portions of the native leaflets. A first clip mechanism 116a can be placed in an open state (e.g., by pulling a tendon member coupled to a spring-loaded lever) to allow the arm member 118 to extend behind a portion of the posterior leaflet PL. With the posterior leaflet PL positioned between the arm member 118 and the outer portion 114 of the joint member 104, the first clip mechanism 116a can be moved to a closed state (e.g., by removing the pulling force applied to the lever) such that the arm member 118 applies pressure to the posterior side of the posterior leaflet PL against it. Similarly, the second clip mechanism 116b can be placed in an open state (e.g., by pulling a tendon member coupled to a spring-loaded lever) such that the arm member 118 can extend behind a portion of the anterior leaflet AL. With the anterior leaflet AL positioned between the arm member 118 and the inner portion 112 of the joint member 104, the second clip mechanism 116b can be moved to a closed state (e.g., by removing the pulling force applied to the lever) such that the arm member 118 applies pressure to the posterior side of the anterior leaflet AL against it. 1D and 1E, the first and second clip mechanisms 116a, 116b capture a central portion of the posterior leaflet PL (P2) and a central portion of the anterior leaflet AL (A2), respectively. In these and other embodiments, the clip mechanisms 116 may capture different and / or additional portions of the native leaflets (e.g., lateral leaflet portions). In some embodiments, one or more of the clip mechanisms 116 may further include features that engage sub-annular cardiac tissue (e.g., underside of the annulus or ventricle) for additional sub-annular stabilization of the device 100.

[0040] The delivery procedure can continue by deploying the fixation member 102 into the atrium. As the fixation member 102 expands, it contacts and engages supranulular tissue along the atrial wall to enable supranulular fixation of the device 100. As shown in FIG. 1C, the friction element 122 can extend into tissue near the posterior portion of the annulus, thereby providing additional fixation. In some embodiments, the fixation member 102 is deployed prior to the coaptation member 104 and / or clip mechanism 116.

[0041] After implantation, the device 100 provides an improved seal during systole, thereby This is expected to reduce or eliminate valve regurgitation and provide proper valve function. That is, the coaptation member 104 can fill a portion of the regurgitating orifice, and the clip mechanism 116 can draw some portions of the leaflets inward so that they can properly coapt with each other and / or to the outer surface of the coaptation member 104. For example, FIGS. 1D and 1E are cross-sectional views (as viewed from the ventricle) of the implanted device 100 during diastole and systole, respectively. During diastole (FIG. 1D), the coaptation member 104 fills a portion of the mitral valve, and the clip mechanism 116 draws in the central portions (P2, A2) of the posterior leaflet PL and anterior leaflet AL so that they are crimped against the coaptation member. The outer portions of the posterior leaflet PL and anterior leaflet AL remain free to relax and separate from each other, thereby opening the valve and allowing blood to flow through the valve. During systole (FIG. 1E), the posterior leaflet PL and anterior leaflet AL move inward to abut against the outer surface of the coaptation member 104, and if not clipped, the leaflets can coapt with each other. Multiple clips 116 supported by the coaptation member 104 can improve the seal for patients with tricky anatomy (e.g., large regurgitant ostia, P1 or P3 prolapse, anterior leaflet prolapse) and / or anatomical changes over time. In various embodiments, the device 100 can have additional or other clipping mechanisms 116 that retract additional or different portions of the native leaflets to provide proper coaptation. In these and other embodiments, the coaptation member 104 can extend along longer or shorter portions of the coaptation line (e.g., between the posterior and anterior commissures) and / or have different cross-sectional shapes to facilitate appropriate coaptation for a particular valve anatomy.

[0042] FIG. 2A is a side cross-sectional view of a valve repair device 200 ("device 200") implanted at a mitral valve in accordance with an embodiment of the present technology, and FIGS. 2B and 2C are side cross-sectional views of the base 200 of FIG. 2A during diastole and systole, respectively. Device 200 may have various features at least generally similar to those of device 100 described above with reference to FIGS. 1A-1E. For example, device 200 has a fixation member 202 that engages at least a portion of an atrial wall, a coaptation member 204 depending from fixation member 202 and configured to be positioned between the natural leaflets (e.g., extending in front of the posterior leaflet PL), and a number of clip mechanisms 216 (individually shown as first clip mechanism 216a and second clip mechanism 216b) configured to extend behind and engage portions of the natural leaflets. In the illustrated embodiment, both clip mechanisms 216 are positioned on the outer portion of the coaptation member 204 such that they engage different portions of the same native leaflet. As shown in FIG. 2B and FIG. 2C, for example, the first clip mechanism 216a engages the central portion (P2) of the posterior leaflet PL, and the second clip mechanism 216b engages the outer portion (e.g., P3) of the posterior leaflet PL. In this embodiment, the device 200 does not include a clip associated with the anterior leaflet AL. Instead, the stability provided by the laterally spaced clip mechanisms 216 provides the necessary subannular fixation. In other embodiments, the device 200 may include clip mechanisms on additional portions of the same native leaflet (e.g., the posterior leaflet PL) and / or along one or more portions of the opposing leaflet (e.g., the anterior leaflet AL).

[0043] 3A and 3B are side cross-sectional views of a valve repair device 300 ("device 300") in a mitral valve during diastole and systole, respectively, in accordance with an embodiment of the present technology. Device 300 can include various features at least generally similar to those of device 200 described above with reference to FIGS. 2A-2C. For example, device 300 can include an optional fixation member (not shown, e.g., fixation members 102, 202 described above), a coaptation member 304 configured to be positioned between opposing native leaflets (e.g., extending in front of the posterior leaflet PL), and multiple clip mechanisms 316 (individually shown as first clip mechanism 316a, second clip mechanism 316b, and third clip mechanism 316c) configured to engage different outwardly spaced portions of the same native leaflet. In the illustrated embodiment, the device 300 has three clip mechanisms 316 located on the same side of the junction member 304 and spaced laterally from one another. As shown in Figures 3A and 3B, for example, a first clip mechanism 316a can engage a central portion (P2) of the posterior leaflet PL, a second clip mechanism 316b can engage an outer portion (e.g., P3) of the posterior leaflet PL, and a third clip mechanism 316c can engage a different outer portion (e.g., P1) of the posterior leaflet PL. The addition of the tertiary clip mechanism 316c provides leaflet support at each scallop of the posterior leaflet PL, drawing each scallop in and sealing it against the outer side of the junction member 304 without residual cracks. The combination of the junction member 304 straddling (partially or entirely) the posterior leaflet PL and the three clip mechanisms 316 providing leaflet support at each scallop can provide sufficient fixation to eliminate the need for fixation members (full or partial). In some embodiments, for example, the securing members may be omitted.In some embodiments, the device 300 can have partial fixation members that extend only along a non-circumferential portion of the atrium (e.g., a semicircular fixation structure, a partial fixation structure that extends less than 360° of the native annular region, a low profile fixation structure as shown in FIG. 4 described below) and / or the coaptor-clip configuration can be coupled to other types of tissue fixation structures (e.g., sub-annular fixation structures). In another embodiment, the device 300 can be configured to engage three scallops of the anterior leaflet AL and / or the device 300 can have a clip mechanism that engages opposing leaflets.

[0044] 4 is a side cross-sectional view of a valve repair device 400 ("device 400") implanted at a mitral valve in accordance with an embodiment of the present technology. Device 400 may have various features at least generally similar to those of devices 100, 200, 300 described above with reference to FIGS. 1A-3B. For example, device 400 has a fixation member 402 that engages at least a portion of the atrial wall, a frictional element 422 protruding from fixation member 402, a coaptation member 404 depending from fixation member 402 and configured to be positioned between the natural leaflets (e.g., extending in front of the posterior leaflet PL), and a number of clip mechanisms 416 (individually shown as first clip mechanism 416a and second clip mechanism 416b) configured to extend behind and engage portions of the natural leaflets. In the illustrated embodiment, a first clip mechanism 416a extends behind and engages the posterior leaflet PL and a second clip mechanism 416b extends behind and engages the anterior leaflet AL such that opposing natural leaflets are both clipped. In these and other embodiments, the device 400 may have three or more clip mechanisms 416 positioned to engage different or additional portions of the natural leaflet and / or two clip mechanisms 416 may be positioned to engage different portions of the same natural leaflet.

[0045] The fixation member 402 may have similar features (e.g., mesh frame, cover, frictional element 422) as the fixation members 102, 202 described above with reference to Figures 1A-2A. However, the width of the portion of the fixation member 402 that extends around the atrium is narrower (as viewed in the flow axis direction) than the width of the fixation members 102, 202, and therefore the outwardly facing surfaces of the fixation member 402 engage atrial tissue to a lesser extent. Furthermore, when subannular fixation is provided by multiple clip mechanisms 416, the low profile fixation member 402 is expected to avoid or inhibit migration of the coaptation member 404 and provide a platform for tissue ingrowth. Furthermore, given its small size, the low profile fixation member 402 may be crimped or otherwise compressed to a small cross-sectional dimension within a delivery catheter (not shown) to facilitate intravascular delivery.

[0046] As shown in FIG. 4, in some embodiments, the low profile fixation member 402 can have one or more connecting elements 424 (individually shown as a first connecting element 424a and a second connecting element 424b) that connect the fixation member 402 to the junction member 404 and / or the clip mechanism 416. For example, the connecting element 424 can extend in a downstream direction from the fixation member 402 and connect to an inner or central portion of the junction member 404 closer to the inner portion of the junction member 404 than to the outer portion. That is, the connecting element 424 can connect to a portion of the junction member 404 that is positioned toward a more central location within the valve, as compared to the outer rear only connecting scheme described above with reference to FIGS. 1A-3B. In some embodiments, the connecting element 424 is used in place of an outer side connecting scheme, whereas in other embodiments, the device 400 can have both an outer side connecting and an inner / center connecting element 424. In various embodiments, the connecting element 424 may extend into the body of the joining member 404 (e.g., through a slit in the cover) and couple to structure therein (e.g., as indicated by the dashed lines). In other embodiments, the device 400 may have additional fixed-joint connecting elements 424 or may omit the connecting element 424.

[0047] 5A and 5B are front and side views of a valve repair device 500 ("device 500") configured in accordance with an embodiment of the present technology. Device 500 has various features at least generally similar to those of devices 100-400 described above with reference to FIGS. 1A-4. For example, device 500 has a fixation member 502 that engages a portion of the atrial wall, a frictional element 522 depending from fixation member 502, a coaptation member 504 depending from fixation member 502 and configured to be positioned between the natural cusps, and a number of clip mechanisms 516 (individually shown as first clip mechanism 516a and second clip mechanism 516b) configured to extend behind and engage portions of the natural cusps. Similar to the fixation members 102, 202 described above with reference to Figures 1A-2A, the fixation member 502 may include a number of struts 506 and open cells 508 forming a frame-like structure, with an optional fabric cover over a portion of the struts 506. However, in the embodiment shown in Figures 5A and 5B, the fixation member 502 does not provide full circumferential support, but instead is an engagement structure configured to extend along a non-circumferential section of the atrium. For example, the partial fixation member 502 may be configured to engage only a posterior portion of the atrial wall. The partial fixation member 502 (also referred to as the "posterior fixation member") may be crimped or otherwise reduced in profile to a small cross-sectional dimension to facilitate intravascular delivery. Furthermore, with the stabilization provided by the multiple clip mechanisms, the partial fixation member 502 may provide sufficient atrial fixation to avoid intraventricular migration.

[0048] 5A and 5B, a first clip mechanism 516a depends from an outer portion 514 of the joint member 504 such that it can capture and grip a portion of the natural cusp (e.g., the posterior cusp) displaced by the joint member 504, and a second clip mechanism 516b depends from an inner portion 512 of the joint member 504 such that it can capture and grip a portion of the natural cusp (e.g., the anterior cusp) displaced by the joint member 504. In some embodiments, the clip mechanisms 516 may be positioned to engage different portions of the same natural cusp and / or the device 500 may include additional clip mechanisms 516 to grip additional or different portions of the natural cusp. The clip mechanisms 516 may have generally similar features to the clip mechanisms 116-416 described above. For example, each clip mechanism 516 has a base portion 520a coupled to the joint member 504, a free end portion 520b extending from the base portion, and an articulatable arm 518 that moves between an open state and a closed state via an actuation mechanism 521 (e.g., a spring-loaded lever). Figure 5A further shows a tensioning member 513 (e.g., a suture) extending through an opening 505 in the baffle cover 503 and into the cavity of the joint member 504, the tensioning member 513 being operably coupled to the actuation mechanism 521 to enable clip actuation.

[0049] The abutment member has a frame 501 and a covering 503 similar to the abutment members 104-404 described above. In some embodiments, a surface of the inner portion 512 of the abutment member 504 (or a portion thereof) may initially serve as the abutment surface. For example, an outer portion of the inner surface 512 may serve as the abutment surface with the cusp engaged at the central portion via the secondary clip mechanism 516b, or the entire inner surface 512 may serve as the abutment surface (without the secondary clip mechanism 516b). At some point after deployment (e.g., during the same procedure or at a later time), a section of the inner surface 512 is operable to open and capture a portion of the opposing natural cusp. When not in use, this actuating section (e.g., the forward facing portion of the secondary clip mechanism 516b) may be sized and shaped to lie substantially or completely flat against the surface of the inner portion, or may be positioned within the abutment member 504 adjacent the inner surface. This inward and / or flush positioning of the working section avoids irritation of the opposing cusp (e.g., the natural cusp) as it abuts against the baffle surface. In some embodiments, the two or more working sections can include two or more flush or internally positioned clip mechanisms, such that the opposing cusp (e.g., the anterior cusp) can be attached more inwardly or more outwardly to the baffle. Attachment to the opposing cusp by two or more clip mechanisms can allow the cusp to be attached along an extension of the abutment member 504.

[0050] FIG. 6 is a side cross-sectional view of a valve repair device 600 ("device 600") with a posterior fixation member implanted at the mitral valve in accordance with an embodiment of the present technology. Device 600 may have various features at least generally similar to those of devices 100-500 described above with reference to FIGS. 1A-5B. For example, device 600 has a partial fixation member 602 that engages at least a portion of the atrial wall, a coaptation member 604 depending from fixation member 602 and configured to be positioned between the natural leaflets, and a number of clip mechanisms 616 (individually shown as first clip mechanism 616a and second clip mechanism 616b) configured to extend behind and engage portions of the natural leaflets. As shown in FIG. 6, rather than angling to one side (e.g., posteriorly or anteriorly), fixation member 602 may position coaptation member 604 laterally outwardly in a central location within the orifice between opposing leaflets. The device 600 may further include tissue fastening features 626 extending from the fixation members 602 and configured to penetrate tissue to facilitate fixation of the device 600. The tissue fastening features 626 may include helical windings similar to a corkscrew shape, screw-like structures, hooks, posts, barbs, and / or other features that facilitate engagement via tissue penetration and / or frictional engagement. In some embodiments, the joining members 604 may be angled to one side and / or the device 600 may include additional or different tissue fastening elements.

[0051] As further shown in FIG. 6, the primary clip mechanism 616a has extensions along its articulatable arms that define a secondary annular fixation segment 632 that enhances secondary annular fixation and stabilization. The secondary annular fixation segment 632 can be sized and shaped (e.g., an inverted U-shape) to curve under the native annulus and press against or otherwise engage adjacent secondary annular tissue. In some embodiments, the secondary annular fixation segment 632 extends a long or short distance under the native annulus and curves back downstream along adjacent tissue (e.g., along the septum or heart wall to form an inverted U-shape) and / or otherwise engage surrounding cardiac tissue. In some embodiments, the secondary annular fixation segment 632 has frictional elements (e.g., barbs, prongs, teeth, corrugations) that enhance engagement with adjacent tissue and promote tissue ingrowth. Additionally, in some embodiments, the clip mechanisms 616 may engage different portions of the natural leaflet and / or the device 600 may include additional clip mechanisms 616.

[0052] FIG. 7 is a side cross-sectional view of a valve repair device 700 ("device 700") implanted at a mitral valve in accordance with an embodiment of the present technology. Device 700 may have various features at least generally similar to those of devices 100-600 described above with reference to FIGS. 1A-6. For example, device 700 has a partial fixation member 702 that engages a portion of the atrial wall, a coaptation member 704 depending from fixation member 702 and configured to be positioned between the natural cusps, and a number of clip mechanisms 716 (individually shown as first clip mechanism 716a and second clip mechanism 716b) configured to extend behind and engage portions of the natural cusps. In the embodiment shown in FIG. 7, partial fixation member 702 is configured to engage an anterior portion of the atrium rather than a posterior portion. Thus, primary clip member 716a, located at an outer portion of coaptation member 704, engages an anterior leaflet AL and secondary clip member 716b engages a posterior leaflet PL. In various embodiments, the clip mechanism 716 can engage different portions of the natural leaflets and / or the device 700 can include additional clip mechanisms 716. The device 700 can further include additional anchoring elements 728 that protrude outwardly from the fixation members 702 and are configured to penetrate adjacent tissue (e.g., near the annulus). The anchoring elements 728 can be posts, screws, helical windings, teeth, barbs, anchors, and / or other features that help to anchor and stabilize the device 700.

[0053] FIG. 8 is a side cross-sectional view of a valve repair device 800 ("device 800") implanted at a mitral valve in accordance with an embodiment of the present technology. Device 800 can have various features at least generally similar to those of devices 100-700 described above with reference to FIGS. 1A-7. For example, device 800 has a natural leaflet and multiple clip mechanisms 816 (individually shown as first clip mechanism 816a and second clip mechanism 816b) configured to extend behind the natural leaflet and engage portions of the natural leaflet. Coaptation member 804 can be centrally located between the leaflets, with first clip mechanism 816a extending behind and grasping the posterior leaflet PL and second clip mechanism 816b extending behind and capturing the opposite anterior leaflet AL. In the illustrated embodiment, device 800 does not include an atrial or supranulular fixation member. Instead, the combination of space-filling interface member 804 and clip mechanism 816 provides sufficient stabilization of the anchoring means within the valve.

[0054] In various embodiments, the coaptation member 804 may be adjustable in length to extend between the commissures of the cusps (e.g., from the posterior commissure to the anterior commissure) and / or the depth to which the coaptation member protrudes into the annulus. For example, the coaptation member 804 may have an expandable body within the cavity of the coaptation member 804 that expands to increase one or more dimensions of the device. The coaptation member 804 may additionally or alternatively have a semi-rigid rod that is moved or inserted to initiate expansion and / or an expandable appendage that increases the dimension of the coaptation member 804. This adjustability allows for proper anchoring within the valve and proper coaptation of the cusps relative to one another in view of the coaptation member 804 and / or the patient's anatomy. In some embodiments, the clip mechanism 816 may engage different portions of the natural cusps and / or the device 800 may have additional clip mechanisms 816 that engage other portions of the natural cusps. In some embodiments, the device 800 can include a secondary annular fixation mechanism, such as an anchoring component, a friction element, and / or a clip arm extension.

[0055] 9A and 9B are side cross-sectional views of a valve repair device 900 ("device 900") positioned within a mitral valve during an intermediate delivery phase and an implantation phase, respectively, in accordance with an embodiment of the present technology. Device 900 may include various features similar to those of devices 100, 200, 300, 400, 500, 600, 700 described above with reference to FIGS. 1A-7. For example, device 900 includes a fixation member 902 that engages at least a portion of an atrial wall, an anchoring element 926 that penetrates tissue near the native annulus, a coaptation member 904 depending from fixation member 902 and configured to be positioned between the native leaflets (e.g., extending in front of the posterior leaflet PL), and a number of clip mechanisms 916 (individually shown as a first clip mechanism 916a and a second clip mechanism 916b) configured to extend behind and engage portions of the native leaflets. In the illustrated embodiment, the fixation member 902 is a partial fixation member (e.g., similar to the fixation members described above with reference to Figures 5 and 6) that engages a non-circumferential portion (e.g., posterior portion) of the atrial wall, and the coaptation member 904 depends from the fixation member 902 in a manner that positions the coaptation member 904 at a central location within the annulus, rather than being tilted to one side. In various embodiments, the fixation member 902 may be sized and shaped to extend along and engage a different section of the atrium (e.g., anterior section), may extend around a circumferential portion of the atrium or annulus, may present a low profile along the flow axis, or may be omitted. In some embodiments, the device 900 may have additional or different fixation elements 926, or may omit the fixation element 926. In some embodiments, the coaptation member 904 is positioned to one side of the native annulus toward one of the native cusps (e.g., tilted posteriorly or anteriorly).

[0056] 9A and 9B, a first clip mechanism 916a protrudes from an outwardly facing surface of the joint member 904 and engages a portion of the posterior leaflet PL, while a second clip mechanism 916b is a separate component that is independently movable relative to the primary clip structure of the joint member and configured to engage the natural leaflet (e.g., the anterior leaflet AL) opposite the joint member 904. In this embodiment, the joint member 904 further includes a clip engagement element 930a (also referred to as a "locking element" or "locking feature") provided along, within, or accessible through the joint surface of the joint member 904. The clip engagement element 930a can interact with a complementary engagement feature 930b of the separate secondary clip mechanism 916b (e.g., provided on an inwardly facing section or surface on the base portion 920a of the clip mechanism 916b) and / or with a portion of the separate secondary clip mechanism 916b itself to attach the two components to one another.

[0057] The first and second engaging elements 930a, 930b (collectively "engaging elements 930") can include one or more fastening means that draw the attachment member 904 and the independent clip mechanism 916b toward one another and maintain their coupling. For example, each engaging element 930 can include one or more magnetic members positioned along an inwardly facing surface of the attachment member 904 and the independent secondary clip mechanism 916b, with the magnetic members of each component having opposite polarity. In this embodiment, the secondary clip mechanism 916b can first be clipped to a portion of the leaflet opposite the attachment member 904 (e.g., the anterior leaflet AL as shown in FIG. 9A), and then the magnetic engaging element 930 can draw the secondary clip mechanism 916b toward the attachment member 904 (e.g., easily during systole), and maintain their coupling due to their mutual magnetic attraction. In some embodiments, the engaging element 930 is a mechanical feature, such as a pin-in slot, a threaded component, a rivet component, an interlocking surface, a hook, and / or a staple, that locks or actuates the independent secondary clip mechanism 916b to or through the joining member 904. In some embodiments, the engaging element 930 includes an adhesive, a suture, an external fastener, and / or other suitable component for joining and maintaining a connection between the joining member 904 and the independent clip mechanism 916b. In some embodiments, only one of the joining member 904 or the independent clip mechanism 916b includes an engaging element 930 that secures the two components together.

[0058] In some embodiments, the instrument 900 has multiple features that aid in coupling and locking the attachment member 904 to the independent secondary clip mechanism 916b. For example, in various embodiments, the engagement element 930 has magnetic features that aid in drawing the attachment member 904 and the independent clip mechanism 916b together to allow for an initial engagement of the two components. After the attachment member 904 and the independent clip mechanism 916b are brought into close proximity with each other, and in some embodiments, temporarily coupled together, the initial coupling is replaced (or supplemented) with a non-magnetic engagement feature (e.g., a mechanical coupling) for a more permanent MRI-compatible attachment. In various embodiments, the instrument 900 may use different features for the initial attachment and the more permanent coupling.

[0059] During device delivery, the main device component (including optional fixation member 902, coaptation member 904, and primary clip mechanism 916a) can be implanted at the native valve as described above. For example, as shown in FIG. 9A, the main device component can be delivered transvascularly (e.g., by trans-aortic or trans-atrial delivery) to the mitral valve and the primary clip mechanism 916a can be actuated to extend behind and engage a portion of the posterior leaflet PL (e.g., P2). The main device component can further include one or more additional clip mechanisms (not shown) that engage different portions of the posterior leaflet PL (e.g., P1 and / or P2). In some embodiments, the coaptation member 904 can function as a new coaptation surface for the anterior leaflet AL without further intervention for a period of time.

[0060] The independent secondary clip mechanism 916b can be delivered transvascularly (e.g., by trans-aortic or trans-atrial delivery) either during the same procedure as the primary component implantation or at a later time during a subsequent procedure. For example, the secondary clip mechanism 916b can be implanted a period of time (e.g., days, months, or potentially years) after the initial implantation of the primary device components, allowing the clinician to assess the fixation and function of the native valve (e.g., coaptation without the secondary clip mechanism) and accommodate the patient's changing anatomy over time. Once the contralateral secondary clip mechanism 916b is implanted (either during the same procedure or a subsequent procedure), the clinician can activate the independent secondary clip mechanism 916b, such that it sandwiches a portion of the free native leaflet (e.g., anterior leaflet AL) between the base portion 920a and the free portion 920b and secures itself to the native leaflet. The operation and structure of the independent secondary clip mechanism 916b may be similar to the operation and structure of the permanently attached clip mechanism described above. For example, the independent clip mechanism 916b may have a spring loaded arm member 918 that is actuable to move between an open state and a closed state by pulling a suture or other pulling member that passes through a delivery catheter. When the independent clip mechanism 916b is delivered in the same procedure as the junction member 904, the independent clip mechanism 916b may be contained within the same delivery catheter as the junction member 904 and may be deployed sequentially before or after the junction member 904. In some embodiments, the independent clip mechanism 916b may be deployed from a separate catheter.

[0061] After the independent clip mechanism 916b is attached to a corresponding native leaflet (e.g., anterior leaflet AL), the independent clip mechanism 916b can be pulled toward the coaptation member 904 such that an inwardly facing surface of the independent clip mechanism 916b (e.g., a surface of the base portion 920a facing toward the native annulus) lines up with a portion of the coaptation surface of the coaptation member 904 and the two components can be joined together by one or more engagement elements 930. In some embodiments, a delivery system can be coupled (e.g., by a pulling member, the catheter itself, a spring) to the deployed independent clip mechanism 916b and used to pull the independent clip mechanism 916b upstream and / or laterally toward the coaptation member 904 (e.g., by proximal movement of the pulling member, catheter, or spring). In some embodiments, the two components are pulled together by the engagement elements 930 themselves, such as by magnetic features, suture loop engagement, and / or other coaptation mechanisms as described above. In some embodiments, the natural movement of the natural leaflet during systole facilitates driving the components together. Once drawn into proper proximity and aligned, the independent clip mechanism 916b and the junction member 904 can be attached to one another by an engagement element 930, which may be the same and / or a different locking mechanism as used to position the two components together. Once the independent secondary clip mechanism 916b is attached to the junction member 904, the device 900 can function in the same manner as the device described above with the integral secondary clip mechanism 916b. In some embodiments, the device 900 can have two or more independent clip mechanisms, such that the two or more independent clip mechanisms are configured to engage different portions of the natural leaflet opposite the junction member 904 (e.g., A1, A2, and / or A3 of the anterior leaflet AL). In these and other embodiments, the device 900 may include one or more independent clip mechanisms configured to engage different portions of the natural cusp to which the primary clip mechanism 916a is attached.

[0062] In various embodiments, the body of the attachment member 904 having an internal open volume can be sized and shaped to accommodate the independent clip mechanism 916b and / or multiple independent clip mechanisms. The independent clip mechanism 916b can initially be retracted within the attachment member 904 and delivery system. After the attachment member 904 is deployed, the independent clip mechanism 916b can be optionally deployed by pushing the independent clip mechanism 916b outwardly in a downstream linear direction from the lower end portion of the attachment member 904 (e.g., via an opening or slit in the downstream end of the attachment member 904). As the independent clip mechanism 916b is advanced from the attachment member 904, it initially extends distally from the attachment member 904 in a reverse orientation with its open curve / U-shape positioned near the opposing natural apex against the heart and the apical region of the base portion 920a. Once the curved / U-shaped portion of the independent clip mechanism 916b has been advanced out of the body of the attachment member 904, the independent clip mechanism 916b returns to its properly oriented curved / U-shape and the independent clip mechanism 916b springs up under the anterior leaflet AL to grasp and grip it against the attachment surface of the attachment member 904. In other embodiments, the independent clip mechanism 916b can be deployed differently from its position housed within the attachment member 904. Because the attachment member 904 extends further towards the opposite anterior leaflet AL than other types of clip devices that do not have a structured body, the independent clip mechanism 916b does not need to have a secondary grasper or apply significant force to hold the anterior leaflet AL against the independent clip mechanism 916b.

[0063] In those embodiments with an independent clip mechanism, the independent clip mechanism 916b can be an optional element of the implant procedure. For example, the coaptation member 904 can be delivered and attached to the posterior leaflet PL first. If reflux persists and the persistent reflux could potentially be addressed by clipping another leaflet to the coaptation member 904, the independent clip mechanism 916b can be activated or delivered differently.

[0064] 10 is a side cross-sectional view of a valve repair device 1000 ("device 1000") positioned within a mitral valve in accordance with an embodiment of the present technology. Device 1000 may include various features similar to those of devices 100-900 described above with reference to FIGS. 1A-9B. For example, device 1000 includes a partial fixation member 1002 that engages a section of the atrial wall (e.g., the posterior section), an anchoring element 1026 that penetrates tissue located near the native annulus, a coaptation member 1004 depending from fixation member 1002 and configured to be positioned between the native leaflets (e.g., extending in front of the posterior leaflet PL), and a primary clip mechanism 1016 configured to extend behind and engage a portion of the native leaflet located at an outer side 1014 of coaptation member 1004. In various embodiments, the fixation members 1002 may be sized and shaped to extend and engage tissue along different sections of the atrium (e.g., anterior sections), may extend all the way around a circumferential portion of the atrium or annulus, may have a low profile along the flow axis, or may omit the fixation members 1002. In some embodiments, the device 1000 may have additional or different fixation elements 1026 or may omit the fixation elements 1026. In some embodiments, the coaptation members 1004 are positioned posteriorly to replace all or a portion of the posterior leaflet PL, positioned anteriorly to replace at least a portion of the anterior leaflet AL, and / or positioned between the leaflets at a generally central location within the annulus.

[0065] 10, the device 1000 may further include an anterior leaflet capture element 1032 configured to be received within and deployed from the body of the attachment member 1004 to capture a portion of the anterior leaflet AL (e.g., a ventricular edge portion) and attach it to the attachment member 1004. For example, the leaflet capture element 1032 may be a curved (e.g., U-shaped, J-shaped, C-shaped) hypotube and / or needle that is preferably operably coupled to a delivery system handle (not shown). After the anastomosis member 1004 is implanted, manipulation of the delivery system handle can cause the leading end 1034 of the curved capture element 1032 to project outwardly from the distal or medial end 1012 of the anastomosis member 1004, move along a lateral axis to curve around the posterior side of the anterior leaflet AL, pierce the anterior leaflet AL with the needle or sharp portion of the leading end 1034 passing through the hypotube, and extend back into the anastomosis member 1004. As shown in FIG. 10 , this causes the capture element 1032 to form a loop around the ventricular edge of the anterior leaflet AL with the capture element 1032 piercing the anterior leaflet AL, such that the capture element 1032 can pull the anterior leaflet AL towards the medial side 1012 against the anastomosis surface or partially into the body of the anastomosis member 1004 as the capture element 1032 is retracted into the anastomosis member 1004. In various embodiments, the capture element 1032 (e.g., if the needle is omitted) does not completely penetrate the natural leaflet, but instead presses against the posterior side of the natural leaflet, pushing it toward or into the coaptation member 1004. Thus, the device 1000 with the primary clip mechanism 1016a and the curved capture element 1032 can grab the edges of the opposing leaflets (e.g., the posterior leaflet PL and the anterior leaflet AL) to provide approximately the same edge-to-edge effect as a device with opposing clip mechanisms. In some embodiments, the device 1000 can include additional leaflet capture elements configured to capture different portions of the anterior leaflet AL and / or the posterior leaflet PL. In various embodiments, the device 1000 can further include one or more additional clip mechanisms configured to capture other portions of the anterior leaflet AL and / or the posterior leaflet PL.

[0066] Another embodiment The following embodiments are illustrative of some examples of the present technology. [Embodiment 1] 1. A valve repair device comprising: an atrial fixation member configured to press against cardiac tissue proximate the native valve annulus; an atrial fixation member extending radially inward away from and from the atrial fixation member, the atrial fixation member having an inner portion having an abutment surface configured to abut with a first native cusp during cardiac systole, an outer portion configured to displace at least a portion of a second native cusp, and a downstream end portion, the abutment member being substantially stationary during the cardiac cycle; 11. A valve repair device comprising: a plurality of clip mechanisms depending from the abutment member, each clip mechanism including a base portion coupled to the downstream end portion of the abutment member, a free end portion not attached to the abutment member, and an articulatable arm member extending in an upstream direction from the base portion and forming the free end portion, the articulatable arm member configured to capture a portion of either the first native cusp or the second native cusp located between the articulatable arm member and the abutment member. [Embodiment 2] The plurality of clip mechanisms include a first clip mechanism extending from the outer portion of the abutment member and configured to capture a portion of the second natural cusp; and a second clip mechanism extending from the inner portion of the coaptation member and configured to capture a portion of the first native leaflet. [Embodiment 3] The plurality of clip mechanisms include a first clip mechanism extending from the outer portion of the abutment member and configured to capture a central portion of the second natural cusp; and a second clip mechanism extending from the outer portion of the coaptation member and configured to capture an outer portion of the second native leaflet. [Embodiment 4] The plurality of clip mechanisms include a first clip mechanism extending from the outer portion of the abutment member and configured to capture a central portion of the second natural cusp; a second clip mechanism extending from the outer portion of the abutment member and configured to capture a first outer portion of the second natural cusp; and a third clip mechanism extending from the outer portion of the coaptation member and configured to capture a second outer portion of the second native leaflet. [Embodiment 5] The coaptation member is configured to be positioned within a mitral valve, the first native leaflet is an anterior leaflet, the second native leaflet is a posterior leaflet, and the plurality of clip mechanisms include: a first clip mechanism extending from the outer portion of the abutment member and configured to capture a P2 portion of the posterior leaflet; a second clip mechanism extending from the outer portion of the joint member and configured to capture a P3 portion of the natural anterior leaflet; and a third clip mechanism extending from the outer portion of the coaptation member and configured to capture a P1 portion of the natural anterior leaflet. [Embodiment 6] The coaptation member is configured to be positioned within a mitral valve, the first native leaflet is an anterior leaflet, the second native leaflet is a posterior leaflet, and the plurality of clip mechanisms include: a first clip mechanism extending from the outer portion of the abutment member and configured to capture a central portion of the posterior leaflet; and a second clip mechanism extending from the inner portion of the coaptation member and configured to capture a central portion of the natural anterior leaflet. [Embodiment 7] The valve repair device of any one of embodiments 1 to 6, wherein the fixation member is configured to position the coaptation member offset outwardly from the valve orifice and angled toward the second valve leaflet. [Embodiment 8] The valve repair device according to any one of the preceding embodiments, wherein the fixation member is configured to position the joining member at a central location within the valve orifice. [Embodiment Item 9] The valve repair device of any one of embodiments 1-8, wherein the fixation member comprises a plurality of interconnected struts defining a row of open cells, and the fixation member is configured to engage cardiac tissue along a circumferential portion of the heart chamber. [Embodiment 10] The valve repair device of any one of embodiments 1-9, wherein the fixation member comprises a plurality of interconnected struts defining a row of open cells, and the fixation member is configured to engage cardiac tissue along a non-circumferential portion of the heart chamber. [Embodiment 11] The valve repair device of any one of embodiments 1 to 10, wherein the fixation members form a low profile frame structure configured to contact a circumferential portion of the heart chamber, the low profile frame structure including a connecting element attached to the inner portion of the attachment member. [Embodiment 12] 12. The valve repair device according to any one of the first to eleventh embodiments, wherein the joining member is crescent-shaped along a cross-section of the valve annulus. [Embodiment 13] 13. The valve repair device of any one of the preceding embodiments, wherein the coaptation member extends along a distance defined by opposing commissures of the first and second native leaflets. [Embodiment 14] 14. The valve repair device of any one of embodiments 1-13, wherein the fixation member has a tissue anchor protruding from a lower portion of the fixation member and configured to penetrate adjacent to the native valve annulus. [Embodiment 15] 15. The valve repair device of any one of embodiments 1-14, wherein the joining member comprises a stent structure configured to increase the length between opposing commissures of the first and second native leaflets. [Embodiment 16] The valve repair device according to any one of the preceding embodiments, wherein the joining members are configured to be dimensionally conforming across their cross-sectional length. [Embodiment 17] 17. The valve repair device of embodiment 16, wherein the coaptation member comprises an expandable component that increases in width relative to the commissure line and / or in depth of protrusion into the native valve orifice. [Embodiment 18] The valve repair device of embodiment 16, wherein the coaptation members are configured to receive a rod that expands the coaptation members in width relative to the commissure line and / or in depth of projection into the native valve orifice. [Embodiment 19] The joining member is a first locking feature located at the inner portion; The plurality of clip mechanisms include a first clip mechanism extending from the outer portion of the abutment member and configured to capture a portion of the second natural cusp; and an independent second clip mechanism, the independent second clip mechanism including a second locking feature configured to engage with the first locking feature to attach the independent second clip mechanism to the inner portion of the joint member. [Embodiment 20] The valve repair device of embodiment 19, wherein the independent second clip mechanism is configured to be received within the joining member prior to deployment. [Embodiment 21] The valve repair device of embodiment 19, wherein the first and second locking mechanisms include magnetic components. [Embodiment 22] The valve repair device of any one of embodiments 1-21, wherein the articulation surface has an actuation section configured to open to capture a portion of the first native leaflet. [Embodiment 23] The valve repair device of any one of embodiments 1 to 22, further comprising a leaflet capture component housed within the coaptation member and configured to penetrate the first native leaflet and capture the first native leaflet. [Embodiment 24] The valve repair device of any one of embodiments 1 to 23, wherein each of the clip mechanisms includes a spring-loaded lever configured to move the articulatable arms between an open state and a closed state. [Embodiment 25] The valve repair device of any one of embodiments 1 to 24, wherein the articulatable arm of one of the clip mechanisms includes a sub-annulus engagement component extending from the free end portion and configured to engage sub-annulus tissue. [Embodiment 26] 1. A valve repair device comprising: a coaptation member configured to be positioned between a posterior leaflet and an anterior leaflet of the mitral valve, the coaptation member comprising: A frame structure including a plurality of struts; a cover configured to extend along at least a portion of the frame structure to form an enclosed chamber within the frame structure; an anterior portion including a surface configured to displace or interface with the anterior leaflet during systole; and a posterior portion configured to displace or join at least a portion of the posterior leaflet; the joint member is substantially stationary during the cardiac cycle; a plurality of clip mechanisms depending from the joining member, one or more of the clip mechanisms comprising: a base portion coupled to the joining member; 14. A valve repair device comprising: an articulatable arm member extending in an upstream direction from the base portion, the articulatable arm member having a free end portion not attached to the joint member, the articulatable arm member configured to capture a portion of the posterior leaflet or the anterior leaflet located between the articulatable arm member and the joint member. [Embodiment 27] The plurality of clip mechanisms include a posterior clip mechanism extending from the posterior portion of the abutment member and configured to capture a portion of the posterior leaflet; 27. The valve repair device of embodiment 26, further comprising an anterior clip mechanism extending from the anterior portion of the coaptation member and configured to capture a portion of the anterior leaflet. [Embodiment 28] The plurality of clip mechanisms include a primary posterior clip mechanism extending from the posterior portion of the abutment member and configured to capture a central portion of the posterior leaflet; 28. The valve repair device of embodiment 26 or 27, further comprising a secondary posterior clip mechanism extending from the posterior portion of the coaptation member and configured to capture an outer portion of the posterior leaflet. [Embodiment 29] The outer portion is a first outer portion and the plurality of clip mechanisms include 29. The valve repair device of embodiment 28, further comprising a tertiary clip mechanism extending from the posterior portion of the coaptation member and configured to capture a second outer portion of the posterior leaflet. [Embodiment 30] The valve repair device of any one of embodiments 26 to 29, further comprising an atrial fixation member coupled to the attachment member and configured to engage cardiac tissue in the left atrium, the attachment member extending radially inward from the atrial fixation member. [Embodiment 31] 31. The valve repair device of embodiment 30, wherein the fixation member comprises a frame structure configured to engage cardiac tissue along a circumferential portion of the left atrium. [Embodiment 32] 31. The valve repair device of embodiment 30, wherein the fixation member comprises a frame structure configured to engage cardiac tissue along a non-circumferential posterior portion of the left atrium. [Embodiment 33] 31. The valve repair device of embodiment 30, wherein the fixation member comprises a frame structure configured to engage cardiac tissue along a non-circumferential anterior portion of the left atrium. [Embodiment 34] The valve repair device of embodiment 30, wherein the coaptation member has a width configured to extend across at least the central scallop of the posterior leaflet. [Embodiment 35] The valve repair device of any one of embodiments 26 to 34, wherein the coaptation member is configured to include an expandable structure for adjusting the width of the coaptation member relative to the commissure line and / or the depth of protrusion into the native mitral valve orifice. [Embodiment 36] the abutment member having a first locking feature located at the forward portion; The plurality of clip mechanisms include a posterior clip mechanism extending from the posterior portion of the abutment member and configured to capture a portion of the posterior leaflet; and an independent anterior clip mechanism, the independent anterior clip mechanism including a second locking feature configured to engage with the first locking feature to attach the independent anterior clip mechanism to the inner portion of the joint member, the anterior clip mechanism configured to engage the anterior leaflet. [Embodiment 37] The plurality of clip mechanisms include a posterior clip mechanism extending from the posterior portion of the abutment member and configured to capture a portion of the posterior leaflet; The valve repair device of any one of embodiments 26 to 36, further comprising: an independent anterior clip mechanism configured to be received within the coaptation member and engage the anterior leaflet. [Embodiment 38] The valve repair device of any one of embodiments 26 to 37, further comprising a leaflet capture component housed within the coaptation member in a state deployable from the coaptation member and configured to penetrate the anterior leaflet and capture the anterior leaflet. [Embodiment 39] The valve repair device of any one of embodiments 26 to 38, wherein each of the clip mechanisms includes a spring-loaded lever configured to move the articulatable arms between an open state and a closed state. [Embodiment 40] The valve repair device of any one of embodiments 26 to 39, wherein the articulatable arms of one of the clip mechanisms include a sub-annulus engagement component configured to engage sub-annulus tissue. [Embodiment 41] 1. A method of repairing a heart valve, the method comprising: deploying a coaptation member of a valve repair device in the regurgitant valve orifice between a first native cusp and a second native cusp, the coaptation member having a first portion facing the first native cusp and a second portion facing the second native cusp, the coaptation member defining an open cavity separating the first portion and the second portion from one another; extending a first articulatable arm of a first clip mechanism behind a central portion of the first natural cusp such that the central portion of the first natural cusp is positioned between the first articulatable arm and the first portion of the joint member; actuating the first articulatable arm such that the first articulatable arm moves to achieve a closed condition in which the first articulatable arm compresses the first natural cusp between the first articulatable arm and the first portion; extending a second articulatable arm of a second clip mechanism behind either an outer portion of the first natural cusp or a central portion of the second natural cusp; actuating the second articulatable arm to cause the second articulatable arm to move and thereby achieve a closed condition in which the second articulatable arm presses against the cusp. [Embodiment 42] The method of embodiment 41 further comprises the step of deploying a fixation member of the valve repair device against the atrial wall such that the fixation member surrounds the native valve annulus, the fixation member forming a central lumen through which blood can flow. [Embodiment 43] The method of embodiment 41 or 42, further comprising the step of deploying a partial fixation member of the valve repair device to engage tissue with a segment of the atrial wall. [Embodiment 44] the step of extending the second articulatable arm of the second clip mechanism includes extending the second articulatable arm behind an outer portion of the first natural leaflet; The method of any one of embodiments 41 to 43, wherein the step of actuating the second articulatable arm includes a step of engaging the outer portion of the first natural cusp between the second articulatable arm and the first portion. [Embodiment 45] the outer portion is a first outer portion; extending a third articulatable arm of a third clip mechanism behind a second outer portion of the first natural cusp; The method of embodiment 44, further comprising the step of actuating the third articulatable arm to engage the second outer portion of the first natural cusp between the third articulatable arm and the first portion. [Embodiment 46] the step of extending the second articulatable arm of the second clip mechanism includes extending the second articulatable arm behind a central portion of the second natural cusp; The method of any one of embodiments 41 to 45, wherein the step of actuating the second articulatable arm includes a step of engaging the second natural cusp between the second articulatable arm and the second portion. [Embodiment 47] 47. The method of any one of embodiments 41-46, wherein the step of deploying the junction member includes the step of extending the junction member across at least a central portion of the first natural cusp. [Embodiment 48] The method of any one of embodiments 41-47, further comprising adjusting a width of the coaptation member across the native annulus. [Embodiment 49] The method of any one of embodiments 41-48, further comprising the step of increasing a dimension of the junction member beyond the natural expansion of the junction member. [Embodiment 50] The method of any one of embodiments 41-49, further comprising the step of deploying the second clip mechanism from within the cavity of the joining member. [Embodiment 51] The method of any one of embodiments 50, further comprising the step of locking a base portion of the second clip mechanism to a second portion of the interface member. [Embodiment 52] deploying a leaflet capture component from the abutment member; The method of any one of embodiments 41-51, further comprising the step of penetrating the second natural cusp to attract the second natural cusp to the joining member. [Embodiment 53] The method of any one of embodiments 41-52, further comprising the step of engaging the sub-annulus cardiac tissue with a sub-annulus engagement component extending from the first clip mechanism. [Embodiment 54] The method of any one of embodiments 41 to 53, wherein deploying the coaptation member of the valve repair device in the regurgitation orifice between the first native leaflet and the second native leaflet comprises deploying the coaptation member of the valve repair device in the mitral orifice between the posterior leaflet and the anterior leaflet.

[0067] conclusion The above description of the embodiments of the present technology is not exhaustive or intended to limit the present technology to the precise form disclosed above. Although specific embodiments and implementations of the present technology have been described above for illustrative purposes, those skilled in the art will recognize that various equivalent modifications are possible within the scope of the present technology. For example, while steps are provided in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0068] In view of the above, although specific embodiments of the present technology are described herein for illustrative purposes, well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Where the context permits, singular or plural terms may include the plural or singular terms, respectively.

[0069] Further, unless the term "or" is expressly limited to mean only a single item exclusive of the other items with reference to a list of two or more items, the use of "or" in such a list should be construed to include (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. In addition, "comprising" as used in the original specification is used throughout the specification to mean including at least the recited features, and therefore does not preclude any multiple of the same features and / or additional types of other features. It will also be understood that while certain embodiments have been described herein for illustrative purposes, various modifications can be made without departing from the technology. Furthermore, while advantages associated with certain embodiments of the technology have been described in the context of these examples, other embodiments may also enjoy such advantages, and not all embodiments necessarily enjoy such advantages to be within the scope of the technology. Thus, the disclosure and related technology can include other embodiments not expressly shown or described herein.

Claims

1. 1. A valve repair device comprising: an atrial fixation member configured to press against cardiac tissue proximate the native valve annulus; an atrial fixation member extending radially inward away from and from the atrial fixation member, the atrial fixation member having an inner portion having an abutment surface configured to abut with a first native cusp during cardiac systole, an outer portion configured to displace at least a portion of a second native cusp, and a downstream end portion, the abutment member being substantially stationary during the cardiac cycle, the abutment member defining an interior volume and an opening to the interior volume; a plurality of clip mechanisms depending from the joint member, each clip mechanism including a base portion coupled to the downstream end portion of the joint member, a free end portion not attached to the joint member, and an articulatable arm member extending in an upstream direction from the base portion and forming the free end portion, the articulatable arm member configured to capture a portion of either the first natural cusp or the second natural cusp located between the articulatable arm member and the joint member; a valve repair device, each of the clip mechanisms further including an actuation mechanism for moving the articulatable arm members between closed and open positions, each of the actuation mechanisms being independently movable via a delivery component inserted through the opening in the joint member and into the interior volume of the joint member.

2. The plurality of clip mechanisms include a first clip mechanism extending from the outer portion of the abutment member and configured to capture a portion of the second natural cusp; a second clip mechanism extending from the inner portion of the coaptation member and configured to capture a portion of the first native leaflet.

3. The plurality of clip mechanisms include a first clip mechanism extending from the outer portion of the abutment member and configured to capture a central portion of the second natural cusp; a second clip mechanism extending from the outer portion of the coaptation member and configured to capture an outer portion of the second natural leaflet.

4. The plurality of clip mechanisms include a first clip mechanism extending from the outer portion of the abutment member and configured to capture a central portion of the second natural cusp; a second clip mechanism extending from the outer portion of the joint member and configured to capture a first outer portion of the second natural cusp; a third clip mechanism extending from the outer portion of the coaptation member and configured to capture a second outer portion of the second native leaflet.

5. The coaptation member is configured to be positioned within a mitral valve, the first native leaflet is an anterior leaflet, the second native leaflet is a posterior leaflet, and the plurality of clip mechanisms include: a first clip mechanism extending from the outer portion of the abutment member and configured to capture a P2 portion of the posterior leaflet; a second clip mechanism extending from the outer portion of the joint member and configured to capture a P3 portion of the natural anterior leaflet; a third clip mechanism extending from the outer portion of the coaptation member and configured to capture a P1 portion of the native anterior leaflet.

6. The coaptation member is configured to be positioned within a mitral valve, the first native leaflet is an anterior leaflet, the second native leaflet is a posterior leaflet, and the plurality of clip mechanisms include: a first clip mechanism extending from the outer portion of the abutment member and configured to capture a central portion of the posterior leaflet; a second clip mechanism extending from the inner portion of the coaptation member and configured to capture a central portion of the natural anterior leaflet.

7. 2. The valve repair device of claim 1, wherein the atrial fixation member is configured to position the coaptation member offset laterally from the valve orifice and angled toward the second native cusp.

8. The valve repair device of claim 1 , wherein the atrial fixation member is configured to position the coaptation member at a central location within the valve orifice.

9. 10. The valve repair device of claim 1, wherein the atrial fixation member is comprised of a plurality of interconnected struts defining an array of openings, the atrial fixation member configured to engage cardiac tissue along a circumferential portion of a heart chamber.

10. 10. The valve repair device of claim 1, wherein the atrial fixation member is comprised of a plurality of interconnected struts defining an array of openings, the atrial fixation member being configured to engage cardiac tissue along a non-circumferential portion of a heart chamber.

11. 10. The valve repair device of claim 1, wherein the atrial fixation member forms a frame structure configured to contact a circumferential portion of a heart chamber, the frame structure including a coupling element attached to the inner portion of the coaptation member.

12. The valve repair device of claim 1 , wherein the coaptation members are crescent shaped along a transverse cross-section of the annulus.

13. The valve repair device of claim 1 , wherein the coaptation members are configured to extend along a distance defined by opposing commissures of the first and second native leaflets.

14. 10. The valve repair device of claim 1, wherein the atrial fixation member has a tissue anchor protruding from a lower portion of the atrial fixation member and configured to penetrate adjacent to the native valve annulus.

15. The valve repair device of claim 1 , wherein the coaptation members include a stent structure configured to increase a length between opposing commissures of the first and second native leaflets.

16. The valve repair device of claim 1 , wherein the coaptation member is configured to conform in size across a cross-sectional length in a direction between the first native cusp and the second native cusp.

17. 17. The valve repair device of claim 16, wherein the coaptation members include expandable components that increase in width relative to the commissure line and / or in depth of projection into the native valve orifice.

18. 17. The valve repair device of claim 16, wherein the coaptation members are configured to receive a rod that expands the coaptation members in width relative to the commissure line and / or in depth of projection into the native valve orifice.

19. The joining member is a first locking feature located at the inner portion; The plurality of clip mechanisms include a first clip mechanism extending from the outer portion of the abutment member and configured to capture a portion of the second natural cusp; and an independent second clip mechanism, the independent second clip mechanism including a second locking feature configured to engage the first locking feature to attach the independent second clip mechanism to the inner portion of the joint member.

20. The valve repair device of claim 19 , wherein the separate second clip mechanism is configured to be received within the coaptation member prior to deployment.

21. The valve repair device of claim 19 , wherein the first locking feature and the second locking feature include magnetic components.

22. The valve repair device of claim 1 , wherein the coaptation surface has an actuation section configured to open to capture a portion of the first native leaflet.

23. The valve repair device of claim 1 , further comprising a leaflet capture component housed within the coaptation member and configured to penetrate and capture the first native leaflet.

24. The valve repair device of claim 1 , wherein each of the clip mechanisms includes a spring-loaded lever configured to move the articulatable arm members between an open state and a closed state.

25. The valve repair device of claim 1 , wherein the articulatable arm member of one of the clip mechanisms includes a sub-annulus engagement component extending from the free end portion and configured to engage sub-annulus tissue.

26. 1. A valve repair device comprising: a coaptation member configured to be positioned between a posterior leaflet and an anterior leaflet of the mitral valve, the coaptation member comprising: a frame structure including a plurality of struts; a cover configured to extend along at least a portion of the frame structure and to form a sealed chamber within the frame structure, the cover including an opening to the sealed chamber; an anterior portion including a surface configured to displace or interface with the anterior leaflet during systole; a posterior portion configured to displace or join at least a portion of the posterior leaflet; the joining member is substantially stationary during the cardiac cycle; a plurality of clip mechanisms depending from the joining member, one or more of the clip mechanisms comprising: a base portion coupled to the joining member; an articulatable arm member extending in an upstream direction from the base portion, the articulatable arm member having a free end portion not attached to the joint member, the articulatable arm member configured to capture a portion of the posterior leaflet or the anterior leaflet located between the articulatable arm member and the joint member; One or more of the clip mechanisms further includes an actuation mechanism that moves the articulatable arm members between closed and open positions, the actuation mechanism being configured to be actuated via a delivery component that is inserted through the opening in the cover and into the sealing chamber of the joint member.

27. The plurality of clip mechanisms include a posterior clip mechanism extending from the posterior portion of the abutment member and configured to capture a portion of the posterior leaflet; an anterior clip mechanism extending from the anterior portion of the coaptation member and configured to capture a portion of the anterior leaflet.

28. The plurality of clip mechanisms include a primary posterior clip mechanism extending from the posterior portion of the joint member and configured to capture a central portion of the posterior leaflet; a secondary posterior clip mechanism extending from the posterior portion of the coaptation member and configured to capture an outer portion of the posterior leaflet.

29. The outer portion is a first outer portion, and the plurality of clip mechanisms include 30. The valve repair device of claim 28, further comprising a tertiary clip mechanism extending from the posterior portion of the coaptation member and configured to capture a second outer portion of the posterior leaflet.

30. 27. The valve repair device of claim 26, further comprising an atrial fixation member coupled to the atrial fixation member and configured to engage cardiac tissue in the left atrium, the atrial fixation member extending radially inward from the atrial fixation member.

31. 31. The valve repair device of claim 30, wherein the atrial fixation member comprises a frame structure configured to engage cardiac tissue along a circumferential portion of the left atrium.

32. 31. The valve repair device of claim 30, wherein the atrial fixation member comprises a frame structure configured to engage cardiac tissue along a non-circumferential posterior portion of the left atrium.

33. 31. The valve repair device of claim 30, wherein the atrial fixation member comprises a frame structure configured to engage cardiac tissue along a non-circumferential anterior portion of the left atrium.

34. 31. The valve repair device of claim 30, wherein the coaptation member has a width configured to extend across at least a central scallop of the posterior leaflet.

35. 27. The valve repair device of claim 26, wherein the coaptation member is configured to include an expandable structure for adjusting a width of the coaptation member relative to a commissure line and / or a depth of protrusion into the native mitral valve orifice.

36. the abutment member having a first locking feature located at the forward portion; The plurality of clip mechanisms include a posterior clip mechanism extending from the posterior portion of the abutment member and configured to capture a portion of the posterior leaflet; 27. The valve repair device of claim 26, comprising: an independent anterior clip mechanism, the independent anterior clip mechanism including a second locking feature configured to engage with the first locking feature to attach the independent anterior clip mechanism to the anterior portion of the coaptation member, the anterior clip mechanism configured to engage the anterior leaflet.

37. The plurality of clip mechanisms include a posterior clip mechanism extending from the posterior portion of the abutment member and configured to capture a portion of the posterior leaflet; 27. The valve repair device of claim 26, comprising: a separate anterior clip mechanism adapted to be received within the coaptation member and engage the anterior leaflet.

38. 27. The valve repair device of claim 26, further comprising a leaflet capture component housed within the coaptation member deployable from the coaptation member and configured to penetrate and capture the anterior leaflet.

39. 27. The valve repair device of claim 26, wherein each of the clip mechanisms includes a spring-loaded lever configured to move the articulatable arm members between an open and a closed position.

40. 27. The valve repair device of claim 26, wherein the articulatable arm member of one of the clip mechanisms includes a sub-annular engagement component configured to engage sub-annular tissue.

41. 27. The valve repair device of claim 26, wherein the opening comprises a slit in the cover.

42. 27. The valve repair device of claim 26, wherein the cover extends along at least a top portion of the frame structure, and the opening is formed in the cover along the top portion.

43. 27. The valve repair device of claim 26, wherein the delivery component is a flexible tendon.

44. 1. A valve repair device comprising: an atrial fixation member configured to press against cardiac tissue proximate the native valve annulus; an atrial fixation member extending radially inward away from and from the atrial fixation member, the atrial fixation member having an inner portion having an abutment surface configured to abut with a first native cusp during cardiac systole, an outer portion configured to displace at least a portion of a second native cusp, and a downstream end portion, the abutment member being substantially stationary during the cardiac cycle, the abutment member defining an interior volume and an opening to the interior volume; a valve repair device having a plurality of clip mechanisms depending from the joint member, each clip mechanism being independently movable via a delivery component inserted through the opening in the joint member and into the interior volume of the joint member to move the clip mechanism between a closed position and an open position.

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