Valve repair device with coaptation structure and plurality of leaflet capture clips

Abstract

Disclosed herein are heart valve repair devices having an engagement member and a plurality of clip mechanisms, and associated systems and methods. A heart valve repair device configured in accordance with embodiments of the present technology can include, for example, an optional fixation member configured to engage tissue within the left atrium in the vicinity of a native mitral valve, an engagement member depending from the fixation member, and a plurality of clip mechanisms extending from a downstream portion of the engagement member. The engagement member can be positioned between the native leaflets and at least partially fill the space between the native leaflets. A first clip mechanism can engage a first portion of one of the native leaflets, and a second clip mechanism can engage another portion of the same native leaflet or an opposing native leaflet.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to and the benefit of U.S. Provisional Application No. 62 / 902,694, filed September 19, 2019, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present technology relates to devices, systems, and methods for heart valve repair, and more particularly to valve repair devices having an engagement structure and a plurality of leaflet capture clips. Background Art

[0004] Mitral regurgitation, mitral valve prolapse, and / or mitral valve stenosis can affect the normal function of the mitral valve. Mitral regurgitation occurs when the leaflets of the mitral valve fail to coapt to apposition during peak systolic pressure, allowing blood to leak from the left ventricle to the left atrium. Several structural factors may affect the normal 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 conditions involve stretching or tearing of the chordae tendineae (tendons connecting the papillary muscles to the underside of the mitral valve leaflets), which may also affect the normal closure of the mitral valve annulus. For example, rupture of the chordae tendineae may cause the valve leaflets to prolapse into the left atrium due to insufficient tension on the leaflets. Abnormal regurgitation can also occur when the papillary muscles are damaged (for example, due to ischemia) so that the affected papillary muscles cannot contract sufficiently to achieve normal closure during systole.

[0005] Mitral valve prolapse occurs when the mitral valve leaflets bulge abnormally into the left atrium, which can also lead to mitral regurgitation. The proper function of the mitral valve can also be affected by mitral stenosis, or a narrowing of the mitral valve orifice, which impedes filling of the left ventricle during diastole.

[0006] Mitral regurgitation is typically treated with diuretics and / or vasodilators to reduce the amount of blood flowing back into the left atrium. Other treatments, such as surgical approaches (open and endovascular), have also been used to repair or replace the native mitral valve. For example, cinching or resecting portions of the dilated annulus is a typical repair method. Cinching of the annulus has been accomplished by implanting annular or peri-annular rings that are substantially fixed to the annulus or surrounding tissue. Other repair procedures also involve suturing or clamping the valve leaflets into partial apposition to each other. Alternatively, more invasive procedures replace the entire valve with a mechanical valve or biological tissue. These invasive procedures are typically performed through large open-chest surgery and are therefore very painful, have a high morbidity rate, and require a long recovery period.

[0007] However, in many repair and replacement procedures, device durability or improper sizing of the annuloplasty ring or replacement valve can lead to complications. Additionally, many repair procedures rely on the skill of the cardiac surgeon, as improper or inaccurate suture placement can compromise the success of the procedure.

[0008] The mitral valve presents unique challenges compared to other heart valves because portions of the mitral annulus have limited radial support from surrounding tissue and the mitral valve has an irregular, unpredictable shape. For example, the anterior wall of the mitral valve is limited only by a thin wall separating the mitral annulus from the inferior aortic outflow tract. Therefore, significant radial forces on the mitral annulus are unacceptable because they could cause collapse of the inferior aortic tract with potentially fatal consequences. Another challenge of the mitral valve anatomy is that the maze of chordae tendineae in the left ventricle makes navigation and positioning of the deployment catheter more difficult than with other heart valves. In view of the difficulties and disadvantages associated with existing procedures, there remains a need for simple, effective, and less invasive devices and methods for treating dysfunctional heart valves.

[0009] BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Many aspects of the present technology may be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed upon clearly illustrating the principles of the present technology.

[0011] Figure 1A and 1B They are respectively a top view and a side view of a valve repair device configured according to an embodiment of the present technology.

[0012] Figure 1C is implanted in the mitral valve according to an embodiment of the present technology Figure 1A and 1B Side cross-sectional view of a valve repair device.

[0013] Figure 1D and 1E According to the embodiments of the present technology Figures 1A-1C Transverse cross-sectional views of the valve repair device during diastole and systole.

[0014] Figure 2A is a side cross-sectional view of a valve repair device implanted at the mitral valve according to an embodiment of the present technology.

[0015] Figure 2B and 2C According to the embodiments of the present technology Figure 2A Side cross-sectional views of the valve repair device during diastole and systole.

[0016] Figure 3A and 3Bare side cross-sectional views of a valve repair device implanted at a mitral valve according to embodiments of the present technology during diastole and systole, respectively.

[0017] Figure 4 is a side cross-sectional view of a valve repair device implanted at a mitral valve having a low-profile fixation member according to embodiments of the present technology.

[0018] Figure 5A and 5B are front and side views of a valve repair device having a posterior fixation member configured according to embodiments of the present technology.

[0019] Figure 6 is a side cross-sectional view of a valve repair device implanted at a mitral valve having a posterior fixation member according to embodiments of the present technology.

[0020] Figure 7 is a side cross-sectional view of a valve repair device implanted at a mitral valve having an anterior fixation member according to embodiments of the present technology.

[0021] Figure 8 is a side cross-sectional view of a valve repair device implanted at a mitral valve according to embodiments of the present technology.

[0022] Figure 9A and 9B are side cross-sectional views of a valve repair device according to embodiments of the present technology shown with an independent clip fitted before and after, respectively.

[0023] Figure 10 is a side cross-sectional view of a valve repair device implanted at a mitral valve according to embodiments of the present technology. DETAILED DESCRIPTION

[0025] The present technology relates to heart valve repair devices having a coaptation structure and multiple clip mechanisms, as well as 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 iterations thereof) includes: (i) a coaptation member (also referred to as a “coaptation structure,” “barrier,” “intra-valve body,” “intermediate structure,” and iterations thereof) positioned between native valve leaflets, and (ii) two or more clip mechanisms (also referred to as a “clip,” “capture clip,” “capture mechanism,” and iterations thereof) that secure the coaptation member to one or more native leaflets (e.g., posterior and / or anterior leaflets of a mitral valve). The coaptation member can be coupled to a fixation member (also referred to as a “rim,” “anchoring structure,” “atrial fixation member,” and iterations thereof) that anchors to cardiac tissue within an atrium and / or provides an ingrowth platform to hold the coaptation member in place.

[0026] The coaptation member at least partially fills a regurgitant orifice in a leaking heart valve (e.g., a mitral valve) and provides a new coaptation surface for the native leaflet to seal against. The coaptation member can push a portion of the native leaflet (e.g., the P2 segment of the posterior leaflet of a native mitral valve) outward toward the ventricular wall while reducing or minimizing damage to the remaining native leaflet. In various embodiments, the coaptation member can have an asymmetric crescent shape in lateral cross-section (i.e., top view) to correspond to the natural shape of the coaptation line of a mitral valve. In some embodiments, the coaptation member has other asymmetric shapes that can correspond to the natural coaptation line of other valves or portions thereof. Such shapes are expected to reduce leakage more effectively than symmetric coaptation members and are expected to further reduce the need to implant multiple separate clip-like devices for normal coaptation, which is common in other clip procedures that lack a coaptation member (e.g., the MitraClip procedure by Abbott Laboratories in Abbott Park, Illinois). For example, in the MitraClip degenerative MR trials (EVEREST II and REALISM), 54% of patients who received a clip received more than one clip (up to two), and in the functional MR trial (COAPT), 64% of 288 patients received more than one clip (up to four).

[0027] When implanted at a mitral valve, the direction of the coaptation member can be rotationally set via a subannular clip (also referred to herein as a "primary clip," "first clip mechanism," and "posterior clip") that is deployed under the native leaflet via a chordae-free region near the center of P2 and is stabilized at the central portion of the posterior leaflet (i.e., P2). The valve repair device can include one or more additional clips that are fixed to different portions of the same leaflet as the primary clip, such as the lateral portions (P1) and / or the medial portion (P3) of the posterior leaflet, and / or to other leaflets, such as the anterior leaflet. For example, a secondary clip can be deployed to fix the coaptation member to the native anterior leaflet (such a secondary clip is also referred to herein as an "anterior clip," "second clip mechanism," and "A2 clip"). The anterior clip can be shorter than the primary clip to avoid extending upward to the aortic valve and potentially damaging the aortic valve function. Alternatively, or in addition to the above-described anterior clip embodiments, the valve repair device can include a clip (e.g., a secondary clip or a tertiary clip) that is rotationally set in direction such that the clip can be deployed at other portions of the posterior leaflet (e.g., P1 or P3) rather than at the anterior leaflet, depending on the shape, size, and location of the regurgitant orifice.

[0028] After the engagement member and the clips have been deployed, the position of the fixation member can be set and deployed in the atrium. In some embodiments, the fixation member is deployed prior to the engagement member and / or the one or more clips. The fixation member secures and stabilizes the engagement member and provides a platform for tissue ingrowth. The additional stability provided by the fixation member can reduce or eliminate the need for friction elements on the clips, thereby reducing or minimizing the impact on the native leaflets during deployment and positioning of the clips. Additionally, the ingrown fixation member can provide a "annuloplasty" effect, thereby limiting further expansion of the mitral annulus due to fibrous tissue coalescence.

[0029] Reference is made below to Figures 1A-10 Specific details of several embodiments of the present technology are described. Although many embodiments are described below with respect to implant devices, systems, and methods for repairing a native mitral valve, other applications and other embodiments are within the scope of the present technology beyond those described herein. For example, the present technology can be used for other target sites, such as the tricuspid valve, the pulmonary valve, and / or the aortic valve. Additionally, several other embodiments of the present technology can have different configurations, components, or processes than those described herein, and features of the illustrated embodiments can be combined with each other. Accordingly, those of ordinary skill in the art will appreciate that the present technology can have other embodiments with additional elements or the present technology can have embodiments without some of the features described below with respect to Figures 1A-10 Other embodiments of several features are shown and described. In certain instances, well-known structures and techniques commonly associated with heart implants and prosthetic heart valves are not shown in detail to avoid obscuring the present technology. The terms used in the description presented below are intended to be interpreted in their broadest reasonable manner, even if it is used in connection with a detailed description of certain specific embodiments of the present technology.

[0030] The accompanying drawings depict embodiments of the present technology and are not intended to be exhaustive or limiting of the present technology. The sizes of the various elements in the drawings can not be to scale and can be arbitrarily expanded or reduced to improve legibility and / or clarity. Wherever possible, the same reference numbers are used in the drawings and the description to refer to the same or like parts. Spelling and grammar can not be perfect in the figures and the description, but can be intended to be as close as possible to the original. Details of components not necessary for an understanding of the present technology can be abstracted in the drawings to exclude certain precise connections and locations of components, such as component positions and certain precise connections between components. Many of the details, sizes, angles, and other features shown in the drawings are for the purpose of illustrating the particular embodiments of the present technology. Accordingly, other embodiments can have other details, sizes, angles, and features without departing from the spirit or scope of the present technology.

[0031] With respect to the terms "distal" and "proximal" in this specification, unless otherwise stated, the terms can provide relative positions of portions of the catheter system with reference to positions in the operator and / or vasculature. Further, as used herein, "forward," "rearward," "upward," "downward," and the like designations do not imply that the referenced components are limited to use in a particular orientation. It will be understood that such designations refer to the orientation of the referenced components as shown in the drawings; systems of the present technology can be used in any orientation that is suitable for the user.

[0032] With respect to the terms "distal" and "proximal" in this specification, unless otherwise stated, the terms can provide relative positions of portions of the catheter system with reference to positions in the operator and / or vasculature. Further, as used herein, "forward," "rearward," "upward," "downward," and the like designations do not imply that the referenced components are limited to use in a particular orientation. It will be understood that such designations refer to the orientation of the referenced components as shown in the drawings; systems of the present technology can be used in any orientation that is suitable for the user.

[0033] Further, as used herein, "forward," "rearward," "upward," "downward," "top," "bottom," and the like designations do not imply that the referenced components are limited to use in a particular orientation. It will be understood that such designations refer to the orientation of the referenced components as shown in the drawings. However, systems of the present technology can be used in any orientation that is suitable for the user.

[0034] The headings provided herein are merely for convenience and should have no interpretive significance, nor limit the meaning or scope of the disclosure.

[0035] Selected embodiments of a valve repair device

[0036] Figure 1A and 1B are top and side views, respectively, of a valve repair device 100 ("device 100") implantable in a heart of a subject (e.g., a human patient) according to embodiments of the present technology. Figures 1C-1E is a device 100 implanted at a mitral valve according to embodiments of the present technology. Figure 1A and 1B are side cross-sectional and transverse cross-sectional views of the device 100. Reference is made to Figure 1A and Figure 1B, the device 100 can include a fixation member 102, an engagement member 104 extending from the fixation member 102 in a downstream direction, and a plurality of clip mechanisms (designated as first clip mechanism 116a and second clip mechanism 116b, respectively; collectively, “clip mechanisms 116”) depending from the engagement member 104. The fixation member 102 is sized and shaped to anchor the device 100 to cardiac tissue proximate the native valve annulus or upstream thereof (e.g., atrial tissue) and to set the position of the engagement member 104 at a desired position relative to the native valve anatomy of the heart between the native valve leaflets. The engagement member 104 has a volume that fills at least a portion of the regurgitant orifice between the native leaflets, can displace at least a portion of one or more native leaflets, and provides an artificial coaptation surface for at least a portion of one or more native leaflets of the heart valve. For example, as shown in Figures 1C-1E FIG. 1, when the device 100 is deployed across the mitral valve annulus, the engagement member 104 can extend in front of the central portion of the posterior leaflet PL (i.e., P2 of the posterior leaflet PL) to set the position of the engagement member 104 at a position that allows it to coapt with the anterior leaflet AL during systole Figure 1E . The clip mechanisms 116 are configured to extend behind and grasp portions of one or more native leaflets to affix the one or more leaflets to the engagement member 104.

[0037] As shown in Figure 1A and 1B , the device 100 is configured relative to a flow axis VA Figure 1B along the direction of blood flow from the atrium to the ventricle and a transverse axis HA Figure 1A at an angle (e.g., orthogonal) to the flow axis VA. The device 100 has a first side P (e.g., posterior side), a second side A (e.g., anterior side) opposite the first side P, an upper end portion S (e.g., first end portion), and a lower end portion I (e.g., second end portion) opposite the upper end portion S.

[0038] In some embodiments, the device 100 can include some features generally similar or identical to the implantable devices described in (i) U.S. Patent Application No. 16 / 044,447, filed July 24, 2018, entitled “Artificial Leaflet Device,” (ii) International Patent Application No. PCT / US2018 / 061126, filed November 14, 2018, entitled “Leaflet Extensions for Heart Valve Leaflets,” (iii) U.S. Patent Application No. 16 / 745,246, filed January 16, 2020, entitled “Implantable Coaptation Assistance Devices with Sensors and Related Systems and Methods,” and / or (iv) U.S. Patent Application No. 16 / 817,464, filed March 12, 2020, entitled “Heart Valve Repair Devices with Annuloplasty Features and Related Systems and Methods,” each of which is incorporated herein by reference in its entirety. Any of the valve repair devices disclosed herein can be delivered to a heart valve intravascularly (e.g., transseptally via a femoral or axillary vein), percutaneously (e.g., transapically), and / or surgically.

[0039] The fixation member 102 can be formed from a mesh, such as a braid or a laser-cut stent-like structure, and / or other types of frames including a plurality of interconnected wires or struts 106 defining a plurality of openings or cells 108 (e.g., diamond-shaped openings) arranged in one or more rows. The struts 106 can be configured to self-expand from a collapsed delivery state (not shown) to an expanded deployed state as shown. Figure 1A and 1B The struts 106 can be made from any biocompatible material, such as stainless steel, nickel-titanium alloy (e.g., nitinol), and / or other suitable stent material. The fixation member 102 in the deployed state can have a generally circular, elliptical, or D-shaped shape and define an open central lumen 110 (also referred to as “opening 110”) that allows blood to pass therethrough along a flow axis VA. When the device 100 is configured to repair a native mitral valve, the shape of the fixation member 102 can be designed to conform to the left atrial wall directly above the mitral annulus to secure the device 100 to the tissue above the annulus. After a period of time (e.g., 3 days, 2 weeks, 1 month, 2 months) after implantation, the fixation member 102 or portions thereof are covered by a layer of tissue, and the tissue ingrowth permanently adheres the device 100 to the atrial wall. As described in further detail below, in some embodiments, the fixation member 102 has a semi-circular or other shape that does not extend completely around the circumference of the native valve. In some embodiments, the fixation member 102 can also or instead include one or more portions that extend into the annulus and / or press against tissue below the annulus to provide fixation of the device below the annulus.

[0040] As Figure 1BAs shown, in some embodiments, the fixation member 102 includes additional fixation elements 122 that protrude outwardly from the fixation member 102 and are configured to enhance 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 enhance tissue engagement. For example, in the illustrated embodiment, the friction elements 122 include two prongs extending outwardly from a lower portion of the fixation member in a downstream direction so that they can protrude into tissue near the annulus. In other embodiments, the fixation member 102 can include additional and / or different friction elements 122.

[0041] like Figure 1A and 1B As shown, the engagement member 104 extends along the flow axis VA away from the downstream portion of the fixing member 102, and at least a portion of the engagement member 104 extends radially inward from the fixing member 102 into the central cavity 110 to fill a portion of the native valve orifice. In the illustrated embodiment, the engagement member 104 is tilted or offset outward from the central valve axis (e.g., in a posterior direction) to push a portion of the adjacent native leaflet back from the valve opening and approximate the closed position of the native leaflet. In some embodiments, the engagement member 104 is more centrally located within the valve orifice. The engagement member 104 can be substantially stationary (e.g., barely moving) during the cardiac cycle, such that the position of the engagement member 104 relative to the fixing member 102 is at least substantially fixed in the deployed state. Thus, unlike the native leaflets that move back and forth to open and close the native valve, the engagement member 104 remains stationary during diastole and systole. In some embodiments, the engagement member 104 does undergo some movement during the cardiac cycle, but to a different extent than the native leaflets.

[0042] The engagement member 104 has an inner portion 112 ( Figure 1B ; also referred to as "first portion", "front portion", "side", or "surface"), the outer portion 114 facing away from the central axis of the valve ( Figure 1B ; also referred to as the "second portion," "back portion," "side," or "surface"), 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"). Inner portion 112 can have a smooth, atraumatic surface 113 (also referred to as the "engaging surface") for engaging at least a portion of one or more opposing native leaflets, while outer portion 114 can displace and engage at least a portion of another native leaflet. In some embodiments, inner portion 112 and / or outer portion 114 can include friction elements that engage the native leaflets.

[0043] The engagement member 104 includes an expandable frame structure 101 (e.g., a mesh structure, a laser cut stent frame) made of a plurality of connected 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 a deployed state. In some embodiments, for example, the frame structure 101 can include interconnected struts (e.g., elongated struts or a mesh structure) 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. Portions of the frame structure 101 can be disconnected (e.g., at the downstream end portion 107), allowing portions of the struts to slide and / or move away from each other to facilitate low profile and adjustable size of the engagement member 104 in a delivery state. The engagement member 104 or portions thereof can be integral with the fixation member 102. For example, struts 106 from the fixation member 102 can extend in a downstream direction to define a portion of the frame structure 101. In other embodiments, the engagement member 104 is a separate structure that is connected to a portion of the fixation member 102 using welding, adhesives, connectors, and / or other suitable connection mechanisms during manufacture.

[0044] A covering 103 (e.g., fabric, graft material) can extend over at least a portion of the frame structure 101 to at least partially enclose the frame structure 101 and provide a smooth, non-traumatic surface for contact with native leaflets pressed thereagainst or engaged therewith. In some embodiments, the covering 103 includes a padding portion (e.g., a biocompatible foam), and / or a biocompatible foam can be attached to the frame structure 101. The covering 103 can extend over the struts in a manner that forms lateral side walls along the inner portion 112 and the outer portion 114 of the engagement member 104, and between the inner portion 112 and the outer portion 114. In some embodiments, the covering 103 can also extend along the downstream end portion 107 and / or the upstream end portion 109 between the inner portion 112 and the outer portion 114, such that the frame structure 101 and the covering 103 together form an enclosed cavity. The covering 103 can include one or more access openings 105, such as slits, valves, or holes in the covering 103 that provide access to the interior of the frame structure 101 and components therein during delivery and / or retrieval. For example, the openings 105 can provide access to delivery system connectors that allow manipulation of the engagement member and / or clip actuation mechanisms to open and close the clip mechanisms 116. In addition, the cavity of the engagement member 104 can house extension members, supplemental clips, and / or other components that can be optionally deployed during an implantation procedure.

[0045] The configuration of the coaptation member 104, particularly the cradle-like structure of the frame 101, lends itself to adjustability of the coaptation member size compared to other clamping devices with / without fillers. In some embodiments, the width of the coaptation member 104 (along the transverse axis HA) and / or the protrusion depth (to what extent it fills the cusp orifice) can be adjustable. This adjustability can be achieved by insertable or removable elements inserted into the body of the coaptation member 104, such as an axial rod that, as it is inserted / removed, expands / contracts the cradle structure of the coaptation member 104. In some embodiments, the coaptation member 104 is divided into sections, including partial or complete sections, that can be inflated and / or passively puffed to fill the regurgitation area. Suitable septal structures, including adjustable septa, are described in International Patent Application No. PCT / US2018 / 043566, filed July 24, 2018, and International Patent Application No. PCT / US2018 / 061126, filed November 14, 2018.

[0046] The clip mechanism 116 extends from the inner portion 112 and / or the outer portion 114 of the coaptation member 104 to allow the clip mechanism 116 to extend behind and capture native leaflets located on one or both sides of the coaptation member 104. The clip mechanism 116 includes a base portion 120a (also referred to as a “first portion”) that is attached to the coaptation member 104, a free end portion 120b (also referred to as a “second portion”) that is not attached to the coaptation member 104, and an articulable arm member 118 that extends from the base portion 120a and forms the free end portion 102b. The base portion 120a can be attached at the downstream end portion 107 of the coaptation member 104 (e.g., to the frame structure 101 and / or the associated cover 103) by welding, adhesive, sutures, and / or other coupling mechanisms. In some embodiments, the base portion 120a can extend in an upstream direction (i.e., in the direction of the flow axis VA) from the downstream end portion 107 along the inner side or the outer side of the coaptation member 104 (depending on the clip location) to provide additional fixation to the coaptation member 104 and / or to provide additional torque for actuating the arm member 118. The arm 118 can extend in an upstream direction (i.e., toward the fixation member 102) from the base portion 120a along the length of the coaptation member 104. For example, the arm member 118 can extend only partially up the coaptation member 104 and along the length of the coaptation member 104 to a downstream end of the fixation member 102. The arm 118 can form an inverted U-shape and flare out to form a wider portion where it clamps the native leaflets. In other embodiments, the arm member 118 can have other suitable shapes for engaging the leaflets and / or can include an extension at the distal-most end that engages subannular tissue for additional subannular stabilization and fixation.

[0047] The arm members 118 can be made of one or more wires, struts, and / or other semi-rigid / rigid structures having sufficient rigidity to grip the leaflets and / or subannular tissue. In some embodiments, the arm members 118 include a fabric covering, biocompatible foam or other type of padding, and / or a coating on the rigid member to provide a smooth surface to reduce trauma to the leaflets and / or surrounding tissue, additional surface area for leaflet engagement, and / or a platform for tissue ingrowth. In some embodiments, the arm members 118 and / or other portions of the clamp mechanism 116 can have spikes, teeth, corrugations, or other friction features to enhance stability and fixation to the native leaflets.

[0048] The clamp mechanism 116 may also include an actuation mechanism 121, such as a spring-loaded lever, that acts on the arm member 118 to engage the arm member 118 in the closed position (e.g., Figures 1A-1E 104; also referred to as a "closed state," "closed configuration," or "first state") and an open position (also referred to as an "open state," "open configuration," or "second state"). In the closed state, the arm member 118 is positioned proximate to or against a surface of the engagement member 104, with at least a portion of the arm member 118 pressing against the surface of the engagement member 104 to provide leaflet engagement. In the open state, the articulatable arm member 118 extends away from the engagement member 104 (e.g., forming a V-shape or L-shape with the surface portion 112 or 114) to allow the free end portion 120b to extend behind the native leaflet and receive the native leaflet between the arm member 118 and the surface of the engagement member 104. In some embodiments, the actuation mechanism 121 maintains the clip mechanism 116 in a normally closed state (e.g., due to a spring force) such that the clip mechanism 116 is in the closed state during device delivery, and manipulation of the actuation mechanism 121 (e.g., pulling a tendon) moves the clip mechanism 116 to the open state. In other embodiments, the clip mechanism 116 is arranged in a normally open state.

[0049] The actuation mechanism 121 can be a spring-loaded lever (e.g., nitinol wire, laser-cut nitinol, or cobalt-chromium sheet) operably coupled to a portion of a delivery system (not shown) that can be manipulated to move the clip mechanism 116 between open and closed positions. For example, a tendon (made of suture or nitinol wire) can be attached to the spring-loaded lever, extending along or through the body of the engagement member 104 (through the opening 105 ( Figure 1A) and extend to an external handle assembly via a delivery catheter. The clinician can pull on the tendon or otherwise apply tension to the tendon, thereby transferring that force to the lever, which moves the arm member 118 between the closed position and the open position. In other embodiments, the actuation mechanism 121 can have different actuation means, such as other springs, clamps, pulleys, interface threaded members, and / or other actuation mechanisms as described in International Patent Application No. PCT / US2018 / 061126, filed November 14, 2018. Moreover, because each clip mechanism 116 includes its own actuation mechanism 121, the clip mechanisms 116 can be independently actuated.

[0050] In the illustrated embodiment, the first clip mechanism 116a depends from the outer portion 114 of the coaptation member 104, while the second clip mechanism 116b depends from the inner portion 112 of the coaptation member 104, such that both clip mechanisms 116 engage portions of opposing native leaflets. For example, when in the mitral valve (e.g., as illustrated), the first clip mechanism 116a can reach under and grasp a central portion of the posterior leaflet PL (i.e., P2), while the second clip mechanism 116b can reach under and grasp a central portion of the atrial leaflet AL (i.e., A2). In some embodiments, the device 100 includes more than two clip mechanisms 116 and / or one of the clip mechanisms 116 can be omitted. In some embodiments, for example, the device 100 includes an additional clip mechanism 116 on the same side as the first clip mechanism 116a and / or on the same side as the second clip mechanism 116b to engage laterally spaced portions of the same native leaflet. Figures 1C-1E

[0051] During a delivery procedure at the mitral valve, the device 100 can be placed in a compressed delivery state within a delivery catheter (not shown) and inserted through the vasculature (e.g., via the femoral vein) to pass through the inferior vena cava to the right atrium. The device 100 is then inserted into the left atrium via a transseptal puncture. The device 100 can be deployed in the left atrium relative to the flow axis VA( Figure 1B ) and the transverse axis TA( Figure 1A ​The orientation of the device 100 is suitably set, and can also be rotated and angularly set relative to a particular landmark. For example, the orientation of the device 100 can be set to align the clip mechanism 116 with a desired portion of the native leaflet. In some embodiments, it can also be possible to re-set the position of the device 100 during the delivery procedure, for example, to correct for misalignment or an inappropriate position. The delivery system can hold the device 100 in a desired orientation and position within the annulus during deployment and release of the device 100. In addition, the delivery system can be configured to allow the device 100 to be re-sheathed, re-set in position, and / or removed prior to full release from the delivery system. In several embodiments, the device 100 can be configured to be deployed via a delivery catheter having a small overall diameter, such as about 15 to 30 French.

[0052] Referring to Figures 1C-1E The device 100 can be deployed from the delivery catheter when the orientation of the device 100 is suitably set within the annulus between the anterior leaflet AL and the posterior leaflet PL. For example, deployment can begin by expanding the engagement member 104 to fill at least a portion of the annulus. As shown in Figure 1C some embodiments, expansion of the engagement member 104 displaces at least a portion of the posterior leaflet PL. The clip mechanism 116 can then be selectively activated to engage portions of the native leaflets. The first clip mechanism 116a can be placed in an open state (e.g., by pulling a tendon coupled to a spring-loaded lever) to allow the arm member 118 to extend behind a portion of the posterior leaflet PL. When the posterior leaflet PL is positioned between the arm member 118 and the outer portion 114 of the engagement member 104, the first clip mechanism 116a can be moved to a closed state (e.g., by releasing the pulling force applied to the lever) such that the arm member 118 exerts pressure against the posterior side of the posterior leaflet PL and clips it. Similarly, the second clip mechanism 116b can be placed in an open state (e.g., by pulling a tendon coupled to a spring-loaded lever) to allow the arm member 118 to extend behind a portion of the anterior leaflet AL. When the anterior leaflet AL is positioned between the arm member 118 and the inner portion 112 of the engagement member 104, the second clip mechanism 116a can be moved to a closed state (e.g., by releasing the pulling force applied to the lever) such that the arm member 118 exerts pressure against the posterior side of the anterior leaflet AL and clips it. As shown in Figure 1D and 1E the first and second clip mechanisms 116a and 116b capture central portions (P2 and A2) of the posterior leaflet PL and the anterior leaflet AL, respectively. In these and other embodiments, the clip mechanism 116 can capture different and / or additional portions of the native leaflets (e.g., lateral leaflet portions). In some embodiments, one or more clip mechanisms 116 can also include features that engage subannular heart tissue (e.g., the underside of the annulus or the ventricular wall) for additional subannular stabilization of the device 100.

[0053] The delivery process can be continued by deploying the fixation member 102 within the atrium. As the fixation member 102 expands, it contacts and engages the supra-annular tissue along the atrial wall to provide supra-annular fixation for the device 100. Figure 1C As shown, friction element 122 can extend into tissue adjacent the posterior portion of the annulus to provide additional fixation. In some embodiments, fixation member 102 is deployed prior to engagement member 104 and / or clip mechanism 116.

[0054] After implantation, the device 100 is expected to provide an improved seal during systole to reduce or eliminate valve regurgitation and provide normal valve function. That is, the engagement member 104 can fill a portion of the regurgitant valve orifice, and the clip mechanism 116 can pull portions of the leaflets inward so that they can engage normally against each other and / or against the outer surface of the engagement member 104. For example, Figure 1D and 1E Figures 1 and 2 show transverse cross-sectional views of the implanted device 100 during diastole and systole, respectively (as viewed from the ventricle). Figure 1D ), the coaptation member 104 fills a portion of the mitral valve, and the clip mechanism 116 pulls in the central portions (P2 and A2) of the posterior leaflet PL and the anterior leaflet AL, causing them to be clamped against the coaptation member. The lateral portions of the posterior leaflet PL and the anterior leaflet AL remain relaxed and separate from each other, thereby opening the valve to allow blood to flow therethrough. During systole ( Figure 1E ), the posterior leaflet PL and the anterior leaflet AL move inward to engage against the outer surface of the engagement member 104, and without being clamped, the leaflets can engage against each other. The multiple clips 116 assisted by the engagement member 104 can provide an improved seal for patients with challenging anatomy (e.g., large regurgitant orifices, P1 or P3 prolapse, anterior leaflet prolapse) and / or anatomy that changes over time. In various embodiments, the device 100 may include additional or other clamping mechanisms 116 that pull in additional or different portions of the native leaflets to provide normal engagement. In these and other embodiments, the engagement member 104 may extend along a longer or shorter portion of the coaptation line (e.g., between the posterior commissure and the anterior commissure) and / or have different cross-sectional shapes to facilitate normal engagement of specific valve anatomy.

[0055] Figure 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, Figure 2B and 2C They are Figure 2A The device 200 may include the side cross-sectional view of the device 200 in diastole and systole. Figures 1A-1EThe features of the device 100 described are at least generally similar to those of the device 200. For example, the device 200 includes a fixation member 202 for cooperating with at least a portion of the atrial wall, an engagement member 204 depending from the fixation member 202 and configured to be positioned between the native leaflets (e.g., extending anteriorly of the posterior leaflet PL), and a plurality of clip mechanisms 216 (individually designated as first clip mechanism 216a and second clip mechanism 216b) configured to extend posteriorly of and cooperate with portions of the native leaflets. In the illustrated embodiment, the two clip mechanisms 216 are each positioned at an exterior portion of the engagement member 204 such that they cooperate with different portions of the same native leaflet. As Figure 2B and 2C shown, for example, the first clip mechanism 216a cooperates with a central portion (P2) of the posterior leaflet PL, while the second clip mechanism 216b cooperates with a lateral 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. Rather, the stability provided by the laterally spaced clip mechanisms 216 provides subannular fixation. In other embodiments, the device 200 can 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 opposite leaflet (e.g., the anterior leaflet AL).

[0056] Figure 3A and 3B are side cross-sectional views of a valve repair device 300 ("device 300") within a mitral valve at diastole and systole, respectively, in accordance with embodiments of the present technology. The device 300 can include a plurality of features that are at least generally similar to those of the device 200 described above with respect to Figures 2A-2C For example, the device 300 can include an optional fixation member (not shown; e.g., the fixation members 102, 202 described above), an engagement member 304 configured to be positioned between the opposite native leaflets (e.g., extending anteriorly of the posterior leaflet PL), and a plurality of clip mechanisms 316 (individually designated as first clip mechanism 316a, second clip mechanism 316b, and third clip mechanism 316c) configured to cooperate with different laterally spaced portions of the same native leaflet. In the illustrated embodiment, the device 300 includes three clip mechanisms 316 that are each positioned at the same side of the engagement member 304 and laterally spaced from one another. As Figure 3A and 3BAs shown, 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 a side portion (e.g., P3) of the posterior leaflet PL, and a third clip mechanism 316c can engage a different side portion (e.g., P1) of the posterior leaflet PL. The addition of a tertiary clip mechanism 316c provides leaflet support at each sector of the posterior leaflet PL, pulling it into a tight fit with the outside of the engagement member 304 without residual gaps. The combination of the engagement member 304 spanning (partial or complete) of the posterior leaflet PL and the three clip mechanisms 316 providing leaflet support at each sector can provide sufficient fixation, thereby eliminating the need for a fixation member (all or part). In some embodiments, for example, the fixation member can be omitted. In some embodiments, the device 300 can include a partial fixation member that extends only along a non-circumferential portion of the atrium (e.g., a semicircular fixation structure, a partial fixation structure that extends around less than 360° of the native annulus area, as shown below Figure 4 In some embodiments, the device 300 may be configured to engage three sectors of the anterior leaflet AL, and / or the device 300 may include a clip mechanism that engages the opposing leaflet.

[0057] Figure 4 is a side cross-sectional view of a valve repair device 400 ("device 400") implanted at the mitral valve according to an embodiment of the present technology. Device 400 may include the same Figures 1A-3B The features of the described devices 100, 200, and 300 are at least substantially similar. For example, the device 400 includes a fixation member 402 for engaging at least a portion of the atrial wall, a friction element 422 projecting from the fixation member 402, an engagement member 404 depending from the fixation member 402 and configured to be positioned between the native leaflets (e.g., extending anteriorly of the posterior leaflet PL), and a plurality of clip mechanisms 416 (individually designated as a first clip mechanism 416a and a second clip mechanism 416b) configured to extend posteriorly and engage with portions of the native leaflets. In the illustrated embodiment, the first clip mechanism 416a extends posteriorly and engages with the posterior leaflet PL, while the second clip mechanism 416b extends posteriorly and engages with a portion of the anterior leaflet AL, such that both opposing native leaflets are clamped. In these and other embodiments, the device 400 can include more than two clip mechanisms 416 positioned to engage different or additional portions of the native leaflet, and / or two clip mechanisms 416 can be arranged to engage different portions of the same native leaflet.

[0058] The fixing member 404 may have a similar structure to that described above. Figures 1A-2A4, 202 as described herein. However, the width of the portion of the fixation member 402 that extends around the atrium (in the direction of the flow axis) is narrower than the width of the fixation member 102, 202, so that the outward-facing surface of the fixation member 402 engages less atrial tissue. Nevertheless, using subannular fixation provided by the plurality of clip mechanisms 416, the low-profile fixation member 404 is expected to help avoid or prevent migration of the engagement member 404 and provide a platform for tissue ingrowth. In addition, given its smaller size, the low-profile fixation member 404 can be crimped or otherwise compressed to a smaller cross-sectional size within a delivery catheter (not shown) to facilitate intravascular delivery.

[0059] like Figure 4 As shown, in some embodiments, the low-profile securing member 402 may include one or more connecting elements 424 (indicated as a first connecting element 424a and a second connecting element 424b) that couple the securing member 402 to the engagement member 404 and / or the clamp mechanism 416. For example, the connecting element 424 may extend from the securing member 402 in a downstream direction to connect with an inner or central portion of the engagement member 404, closer to the inner portion 404 of the engagement member than to the outer portion. That is, similar to the above description regarding Figures 1A-3B In contrast to the description of only the outer, rearward connection, the connection element 424 can be connected to a portion of the engagement member 404 that is positioned toward a central location within the valve. In some embodiments, the connection element 424 is used in place of the outer connection, while in further embodiments, the device 400 can include both the outer connection and the inner / central connection element 424. In various embodiments, the connection element 426 can extend into the body of the engagement member 404 (e.g., via a seam in the covering) and connect to the structure therein (e.g., as shown in dashed lines). In other embodiments, the device 400 can include additional fixation-engagement connection elements 424 or can omit the connection element 424.

[0060] Figure 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 includes the same Figures 1A-4 The features of the described devices 100-400 are at least substantially similar. For example, the device 500 includes a fixation member 502 for engaging a portion of an atrial wall, a friction element 522 protruding from the fixation member 502, an engagement member 504 depending from the fixation member 502 and configured to be positioned between the native leaflets, and a plurality of clip mechanisms 516 (individually designated as a first clip mechanism 516a and a second clip mechanism 516b) configured to extend behind and engage portions of the native leaflets.Figures 1A-2A The described fixation members 102, 202 are similar, the fixation member 502 can include a plurality of struts 506 and open cells 508 forming a framework-like structure, and an optional fabric covering over a portion of the struts 506. However, in the illustrated embodiment, the fixation member 502 does not form a full circumferential support, but rather provides a mating structure configured to extend along a non-circumferential portion of the atrium. For example, the partial fixation member 502 can be configured to mate only the posterior portion of the atrial wall. The partial fixation member 502 (also referred to as a “posterior fixation member”) can be crimped or otherwise reduced in profile to a smaller cross-sectional dimension to facilitate endovascular delivery. Moreover, the partial fixation member 502 can provide sufficient atrial fixation to avoid ventricular migration given the stability provided by the plurality of clip mechanisms. Figure 5A and 5B In the illustrated embodiment, the fixation member 502 does not form a full circumferential support, but rather provides a mating structure configured to extend along a non-circumferential portion of the atrium. For example, the partial fixation member 502 can be configured to mate only the posterior portion of the atrial wall. The partial fixation member 502 (also referred to as a “posterior fixation member”) can be crimped or otherwise reduced in profile to a smaller cross-sectional dimension to facilitate endovascular delivery. Moreover, the partial fixation member 502 can provide sufficient atrial fixation to avoid ventricular migration given the stability provided by the plurality of clip mechanisms.

[0061] As further shown, a first clip mechanism 516a depends from the outer portion 514 of the coaptation member 504 such that it can capture and grasp a portion of a native leaflet (e.g., the posterior leaflet) displaced by the coaptation member 504, and a second clip mechanism 516b depends from the inner portion 512 of the coaptation member 504 such that it can capture and grasp a portion of the opposite native leaflet (e.g., the anterior leaflet). In some embodiments, the clip mechanisms 516 can be arranged to mate with different portions of the same native leaflet, and / or the device 500 can include additional clip mechanisms 516 to grasp additional or different portions of the native leaflets. The clip mechanisms 516 can include generally similar features as the clip mechanisms 116-416 described above. For example, the clip mechanisms 516 each include a base portion 520a coupled to the coaptation member 504, a free end portion 520b extending therefrom, and an articulable arm 518 that moves between open and closed states via an actuation mechanism 521 (e.g., a spring-loaded lever). Figure 5A and 5B As further shown, a first clip mechanism 516a depends from the outer portion 514 of the coaptation member 504 such that it can capture and grasp a portion of a native leaflet (e.g., the posterior leaflet) displaced by the coaptation member 504, and a second clip mechanism 516b depends from the inner portion 512 of the coaptation member 504 such that it can capture and grasp a portion of the opposite native leaflet (e.g., the anterior leaflet). In some embodiments, the clip mechanisms 516 can be arranged to mate with different portions of the same native leaflet, and / or the device 500 can include additional clip mechanisms 516 to grasp additional or different portions of the native leaflets. The clip mechanisms 516 can include generally similar features as the clip mechanisms 116-416 described above. For example, the clip mechanisms 516 each include a base portion 520a coupled to the coaptation member 504, a free end portion 520b extending therefrom, and an articulable arm 518 that moves between open and closed states via an actuation mechanism 521 (e.g., a spring-loaded lever). Figure 5A As further shown, a tension member 513 (e.g., a suture) is extended into the cavity of the coaptation member 504 via an opening 505 in the bulkhead covering 503, where the tension member 513 is operably coupled to the actuation mechanism 521 to effectuate clip actuation.

[0062] The coaptation member includes a frame 501 and a covering 503 similar to coaptation members 104-404 described above. In some embodiments, the inner portion 512 of the coaptation member 504 (or a portion thereof) can initially have a surface that functions as a coaptation surface. For example, a lateral portion of the inner surface 512 can function as a coaptation surface with leaflets being engaged via second clip mechanisms 516b at a central portion, or the entire inner surface 512 can function as a coaptation surface (without second clip mechanisms 516b). At some time after deployment (e.g., during the same procedure or some time thereafter), a portion of the inner surface 512 can be actuated to open and capture a portion of an opposing native leaflet. When not in use, the actuated portion (e.g., a forward facing portion of the second clip mechanisms 516b) can be sized and shaped to lie substantially or completely flat against the surface of the inner portion, or positioned within the coaptation member 506 adjacent to the inner surface. This internal and / or flush positioning of the actuated portion avoids irritation of the opposing leaflet (e.g., the native leaflet) as it coapts against the barrier surface. In some embodiments, there can be more than one actuated portion including more than one clip mechanism positioned flush or internally such that the opposing leaflet (e.g., the anterior leaflet) can be attached more medially or laterally to the barrier. By attaching to the opposing leaflet with more than one clip mechanism, the leaflet can be attached along an extended portion of the coaptation member 504.

[0063] Figure 6 is a side cross-sectional view of a valve repair device 600 ("device 600") having a posterior fixation member implanted at a mitral valve in accordance with embodiments of the present technology. The device 600 can include a number of features that are at least substantially similar to features of the devices 100-500 described above with respect to Figures 1A-5B For example, the device 600 includes a partial fixation member 602 for engaging at least a portion of an atrial wall, a coaptation member 604 depending from the fixation member 602 and configured to be positioned between native leaflets, and a plurality of clip mechanisms 616 (individually designated first clip mechanisms 616a and second clip mechanisms 616b) configured to extend behind and engage portions of the native leaflets. As shown, the fixation member 602 can position the coaptation member 604 laterally outward to a central position within the valve orifice between opposing native leaflets, rather than at an angle (e.g., posterior or anterior) to one side. The device 600 can also include tissue anchoring features 626 protruding from the fixation member 602 and configured to penetrate tissue to enhance fixation of the device 600. The tissue anchoring features 626 can include helical windings similar to a spiral shape, screw-like structures, hooks, posts, barbs, and / or other features that enhance engagement via tissue penetration and / or frictional fit. In some embodiments, the coaptation member 604 can be biased to one side and / or the device 600 can include additional or different tissue anchoring elements. Figure 6 For example, the device 600 includes a partial fixation member 602 for engaging at least a portion of an atrial wall, a coaptation member 604 depending from the fixation member 602 and configured to be positioned between native leaflets, and a plurality of clip mechanisms 616 (individually designated first clip mechanisms 616a and second clip mechanisms 616b) configured to extend behind and engage portions of the native leaflets. As shown, the fixation member 602 can position the coaptation member 604 laterally outward to a central position within the valve orifice between opposing native leaflets, rather than at an angle (e.g., posterior or anterior) to one side. The device 600 can also include tissue anchoring features 626 protruding from the fixation member 602 and configured to penetrate tissue to enhance fixation of the device 600. The tissue anchoring features 626 can include helical windings similar to a spiral shape, screw-like structures, hooks, posts, barbs, and / or other features that enhance engagement via tissue penetration and / or frictional fit. In some embodiments, the coaptation member 604 can be biased to one side and / or the device 600 can include additional or different tissue anchoring elements.

[0064] As Figure 6 Further shown, primary clip mechanism 616a includes an extension along its articulable arm that defines an infra-annular anchoring portion 632 for enhanced infra-annular anchoring and stabilization. Infra-annular anchoring portion 632 can be sized and shaped to curve under the native annulus (e.g., an inverted U-shape) and press against or otherwise engage adjacent infra-annular tissue. In some embodiments, infra-annular anchoring portion 632 extends a longer or shorter distance under the native annulus, curves back in a downstream direction along adjacent tissue (e.g., along the septum or heart wall to form an inverted U-shape), and / or otherwise engages surrounding heart tissue. In some embodiments, infra-annular anchoring portion 632 includes frictional elements (e.g., barbs, prongs, teeth, corrugations) that enhance engagement with adjacent tissue and tissue ingrowth. Further, in some embodiments, clip mechanism 616 can engage different portions of the native leaflets, and / or device 600 can include additional clip mechanisms 616.

[0065] Figure 7 is a side cross-sectional view of a valve repair device 700 ("device 700") implanted at a mitral valve according to embodiments of the present technology. Device 700 can include a number of features that are at least substantially similar to features of devices 100-600 described above with respect to Figures 1A-6 For example, device 700 includes a partial fixation member 702 for engaging a portion of the atrial wall, an engagement member 704 depending from fixation member 702 and configured to be positioned between the native leaflets, and a number of clip mechanisms 716 (individually designated first clip mechanism 716a and second clip mechanism 716b) configured to extend behind and engage portions of the native leaflets. In Figure 7 In the illustrated embodiment, partial fixation member 702 is configured to engage the anterior portion of the atrium, rather than the posterior portion. As such, primary clip mechanism 716a at an outer portion of engagement member 704 engages the anterior leaflet AL, and secondary clip mechanism 716b engages the posterior leaflet PL. In a number of embodiments, clip mechanisms 716 can engage different portions of the native leaflets, and / or device 700 can include additional clip mechanisms 716. Device 700 can further include additional anchoring elements 728 that protrude outward from fixation member 702 and are configured to penetrate adjacent tissue (e.g., near the annulus). Anchoring elements 728 can be posts, screws, helical windings, teeth, barbs, anchors, and / or other features for anchoring and stabilizing device 700.

[0066] Figure 8 is a side cross-sectional view of a valve repair device 800 ("device 800") implanted at a mitral valve according to embodiments of the present technology. Device 800 can include a number of features that are at least substantially similar to features of devices 100-600 described above with respect to Figures 1A-7The features of the described devices 100-700 are at least generally similar to one another. For example, device 800 includes an engagement member 804 configured to be positioned between native leaflets and a plurality of clip mechanisms 816 (individually designated as first clip mechanism 816a and second clip mechanism 816b) configured to extend behind and engage portions of the native leaflets. Engagement member 804 can be more centrally positioned between the leaflets, first clip mechanism 816a can extend behind and grasp the posterior leaflet PL, and second clip mechanism 816b can extend behind and capture the opposing anterior leaflet AL. In the illustrated embodiment, device 800 does not include an atrial or supra-annular fixation member. Instead, the combination of space-filling engagement member 804 and clip mechanisms 816 provide sufficient stabilization and anchoring within the valve.

[0067] In various embodiments, engagement member 804 can be adjustable to extend over a length between commissures of the leaflets (e.g., from a posterior commissure to an anterior commissure) and / or a depth of its protrusion within the annulus. For example, engagement member 804 can include an expandable body within a cavity of engagement member 804 that expands to increase one or more dimensions of the device. Engagement member 804 can also or instead include semi-rigid rods of expandable appendages that are moved or inserted to initiate expansion and / or increase the dimensions of engagement member 804. Such adjustability can provide for proper anchoring within the valve and normal coaptation of the leaflets against engagement member 804 and / or each other, given the patient’s anatomy. In some embodiments, clip mechanisms 816 can engage different portions of the native leaflets, and / or device 800 can include additional clip mechanisms 816 for engaging other portions of the native leaflets. In some embodiments, device 800 can include additional infra-annular fixation mechanisms, such as anchoring components, friction elements, and / or extensions of clip arms.

[0068] Figure 9A and 9B are side cross-sectional views of a valve repair device 900 (“device 900”) positioned in a mitral valve during an intermediate delivery phase and a post-implantation phase, respectively, in accordance with embodiments of the present technology. Device 900 can include features similar to those described above with respect to devices 100-700, including engagement member 804 and clip mechanisms 816. In the illustrated embodiment, device 900 includes an atrial fixation member 902 that is configured to be positioned on the atrial side of the native leaflets. In some embodiments, device 900 can include a supra-annular fixation member (not shown) that is configured to be positioned on the supra-annular side of the native leaflets. In some embodiments, device 900 can include both an atrial fixation member 902 and a supra-annular fixation member. Figures 1A-7The features of the described devices 100, 200, 300, 400, 500, 600, 700 are similar to those of the device 900. For example, the device 900 includes a fixation member 902 for cooperating with at least a portion of the atrial wall, an anchoring element 926 that penetrates tissue in the vicinity of the native annulus, an engagement member 904 that depends from the fixation member 902 and is configured to be positioned between the native leaflets (e.g., extending anteriorly of the posterior leaflet PL), and a plurality of clip mechanisms 916 (individually designated as first clip mechanism 916a and second clip mechanism 916b) that are configured to extend posteriorly of and cooperate with portions of the native leaflets. In the illustrated embodiment, the fixation member 902 is a partial fixation member that cooperates with a non-circumferential portion (e.g., a posterior portion) of the atrial wall (e.g., as described above with respect to FIGS. 5 and 6), and the engagement member 904 depends from the fixation member 902 in a manner that positions the engagement member 904 at a central location within the annulus rather than being canted to one side. In various embodiments, the fixation member 902 can be sized and shaped to extend along and cooperate with different portions of the atrium (e.g., an anterior portion), can extend around a circumferential portion of the atrium or annulus, can have a low profile along the flow axis, or can be omitted. In some embodiments, the device 900 can include additional or different anchoring elements 926, or the anchoring elements 926 can be omitted. In some embodiments, the position of the engagement member 904 is disposed to one side (e.g., canted posteriorly or anteriorly) of the native annulus toward one of the native leaflets. Figure 6 Those described above are similar to those of the device 900, and the engagement member 904 depends from the fixation member 902 in a manner that positions the engagement member 904 at a central location within the annulus rather than being canted to one side. In various embodiments, the fixation member 902 can be sized and shaped to extend along and cooperate with different portions of the atrium (e.g., an anterior portion), can extend around a circumferential portion of the atrium or annulus, can have a low profile along the flow axis, or can be omitted. In some embodiments, the device 900 can include additional or different anchoring elements 926, or the anchoring elements 926 can be omitted. In some embodiments, the position of the engagement member 904 is disposed to one side (e.g., canted posteriorly or anteriorly) of the native annulus toward one of the native leaflets.

[0069] As described above Figure 9A and 9B In the illustrated embodiment, the first clip mechanism 916a protrudes from an outward-facing surface of the engagement member 904 to cooperate with a portion of the posterior leaflet PL, while the second clip mechanism 916b is a separate component that is independently movable relative to the engagement member- primary clip structure and is configured to cooperate with a native leaflet opposite the engagement member 904 (e.g., the anterior leaflet AL). In this embodiment, the engagement member 904 further includes a clip-cooperating element 930a (also referred to as a “locking element” or “locking feature”) along, within, or accessible via an engagement surface of the engagement member 904. The clip-cooperating element 930a can interact with a complementary cooperating feature 930b of the independent secondary clip mechanism 916b (e.g., on or at an inward-facing portion of the base portion 920a of the clip mechanism 916b) and / or with a portion of the independent secondary clip mechanism 916b itself to affix the two components together.

[0070] The first and second mating elements 930a and 930b (collectively, "mating elements 930") can include one or more fastening means for drawing the coaptation member 904 and the independent clip mechanism 916b toward one another and maintaining a connection therebetween. For example, each mating element 930 can include one or more magnetic members positioned along an inward-facing surface of the coaptation member 904 and the independent secondary clip mechanism 916b, with the one or more magnetic members of each component having opposite poles. In this embodiment, the secondary clip mechanism 916b can first be clipped to a portion of the leaflet opposite the coaptation member 904 (e.g., the anterior leaflet AL as shown in Figure 9A some embodiments, the mating elements 930 are mechanical features, such as pin-in-slot mechanisms, threaded components, rivet components, interlocking surfaces, hooks, and / or pegs that lock or actuate the independent secondary clip mechanism 916b to or through the coaptation member 904. In some embodiments, the mating elements 930 include adhesives, sutures, external fasteners, and / or other suitable components for coupling and maintaining a connection between the coaptation member 904 and the independent clip mechanism 916b. In some embodiments, only one of the coaptation member 904 or the independent clip mechanism 916b includes the mating elements 930 for securing the two components together.

[0071] In some embodiments, the device 900 includes multiple features that facilitate coupling and locking the coaptation member 904 to the independent secondary clip mechanism 916b. For example, in various embodiments, the mating elements 930 include magnetic features for drawing the coaptation member 904 and the independent clip mechanism 916b together and providing an initial mating of the two components. After the coaptation member 904 and the independent clip mechanism 916b are drawn close to one another and, in some embodiments, temporarily coupled together, the initial connection is replaced (or supplemented) by a non-magnetic mating feature (e.g., a mechanical connection) for a more permanent, MRI-compatible attachment. In various embodiments, the device 900 can use different features for the initial attachment and the more permanent connection.

[0072] During device delivery, the primary device components (including the optional fixation member 902, the coaptation member 904, and the primary clip mechanism 916a) can be implanted at the native valve as described above. For example, as Figure 9AAs shown, the primary device component can be endovascularly delivered at the mitral valve (e.g., via transaortic or transatrial delivery), 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 primary device component can also include one or more additional clip mechanisms (not shown) for engaging different portions of the posterior leaflet PL (e.g., PI and / or P2). In some embodiments, the coaptation member 904 can serve as a new coaptation surface for the anterior leaflet AL without further intervention over a period of time.

[0073] The independent secondary clip mechanism 916b can be endovascularly delivered (e.g., via transaortic or transatrial delivery) during the same procedure as the primary component implant, or in a later, subsequent procedure. For example, the secondary clip mechanism 916b can be implanted after a period of time (e.g., days, months, or possibly years) after the initial implantation of the primary device component, to allow the clinician to assess the fixation and function of the native valve (e.g., without the coaptation of the secondary clip mechanism), and to adapt to the patient’s anatomy over time. When the secondary opposing clip mechanism 916b is implanted (in the same or a subsequent procedure), the clinician can actuate the independent secondary clip mechanism 916b to clamp a portion of the free native leaflet (e.g., the anterior leaflet AL) between the base portion 920a and the free portion 920b, and to secure itself to the native leaflet. The actuation and structure of the independent secondary clip mechanism 916b can be similar to that of the permanently attached clip mechanism described above. For example, the independent clip mechanism 916b can include a spring-loaded arm member 918 that can be actuated by pulling a suture or other tensioning member that extends through the delivery catheter to move between an open state and a closed state. When the independent clip mechanism 916b is delivered in the same procedure as the coaptation member 904, the independent clip mechanism 916b can be housed in the same delivery catheter as the coaptation member 904, and deployed sequentially before or after the coaptation member 904. In some embodiments, the independent clip mechanism 916b can be deployed from a separate catheter.

[0074] After the independent clip mechanism 916b is attached to the corresponding native leaflet (e.g., anterior leaflet AL), the independent clip mechanism 916b can be drawn toward the coaptation member 904 such that the inward-facing surface of the independent clip mechanism 916b (e.g., the surface of the base portion 920a that faces the native annulus) is aligned with a portion of the coaptation surface of the coaptation member 904, and the two components can be coupled together via one or more mating elements 930. In some embodiments, a delivery system can be coupled to the deployed independent clip mechanism 916b (e.g., via a tensioning member, a catheter itself, a spring) and used to draw the independent clip mechanism 916b toward the coaptation member 904 (e.g., via proximal movement of the tensioning member, catheter, or spring). In some embodiments, the two components are drawn together via the mating elements 930 themselves, such as the magnetic features described above, suture loop mating, and / or other coupling mechanisms. In some embodiments, the natural motion of the native leaflet during systole helps drive the components together. Once drawn suitably close to and aligned with one another, the independent clip mechanism 916b and the coaptation member 904 can be affixed together via the mating elements 930, which can be the same and / or different locking mechanisms as those used to set the position of the two components together. Once the independent secondary clip mechanism 916b is attached to the coaptation member 904, the device 900 can function in a similar manner as the devices described above with an integrated secondary clip mechanism 916b. In some embodiments, the device 900 can include more than one independent clip mechanism such that two or more independent clip mechanisms are configured to mate with different portions of the native leaflet opposite the coaptation member 904 (e.g., Al, A2, and / or A3 of the anterior leaflet AL). In these and other embodiments, the device 900 can include one or more intended clip mechanisms configured to mate with different portions of the native leaflet to which the primary clip mechanism 916a is attached.

[0075] In various embodiments, the size and shape of the body of the coaptation member 904 having an interior open volume can be designed to accommodate a standalone clip mechanism 916b and / or multiple standalone clip mechanisms. The standalone clip mechanism 916b can initially be retracted within the coaptation member 904 and delivery system. After the coaptation member 904 is deployed, the standalone clip mechanism 916b can then be optionally deployed by pushing it out of the lower end portion of the coaptation member 904 (e.g., via an opening or slit in the downstream end of the coaptation member 904) in a downstream linear direction. When the standalone clip mechanism 916b is pushed out of the coaptation member 904, it initially extends distally from the coaptation member 904 in an inverted orientation with the curved / U-shaped portion opening towards the cusp region of the heart, with the base portion 920a positioned closer to the opposing native leaflet. Once the curved / U-shaped portion of the standalone clip mechanism 916b is pushed out of the body of the coaptation member 904, the standalone clip mechanism 916b reverts to its normally oriented curved / U-shaped orientation and the standalone clip mechanism 916b flips under the anterior leaflet AL, grasping it and pinning it against the coaptation surface of the coaptation member 904. In other embodiments, the standalone clip mechanism 916b can be deployed differently than its position of accommodation within the coaptation member 904. Because the coaptation member 904 extends further towards the opposing anterior leaflet AL than other types of clip devices that do not include a structured body, the standalone clip mechanism 916b does not need to have secondary graspers or exert a substantial amount of force to hold the anterior leaflet AL against the standalone clip mechanism 916b.

[0076] In these embodiments with standalone clip mechanisms, the standalone clip mechanism 916b can be an optional element of the implantation procedure. For example, the coaptation member 904 can be delivered first and attached to the posterior leaflet PL. If regurgitation persists and it is likely that clipping the other leaflet to the coaptation member 904 will resolve the persistent regurgitation, the standalone clip mechanism 916b can be actuated or otherwise delivered.

[0077] Figure 10 is a side cross-sectional view of a valve repair device 1000 ("device 1000") positioned in a mitral valve in accordance with embodiments of the present technology. The device 1000 can include a coaptation member 1004 and a standalone clip mechanism 1016b as described above with respect to Figures 1A-9BThe invention also provides a method for manufacturing a device 1000 that is adapted to manufacture a device 1000 having a plurality of features similar to those of the devices 100-900 described herein. For example, the device 1000 includes a portion of a fixation member 1002 for engaging a portion of an atrial wall (e.g., a posterior portion), an anchoring element 1026 that penetrates tissue adjacent to the native annulus, an engagement member 1004 depending from the fixation member 1002 and configured to be positioned between the native leaflets (e.g., extending anteriorly of the posterior leaflet PL), and a primary clamping mechanism 1016 configured to extend posteriorly and engage a portion of the native leaflets at an outer side 1014 of the engagement member 1004. In various embodiments, the fixation member 1002 can be sized and shaped to extend and engage tissue along a different portion of the atrium (e.g., anteriorly), can extend around a circumferential portion of the atrium or annulus, have a low profile along the flow axis, or can be omitted. In some embodiments, the device 1000 can include additional or different anchoring elements 1026, or can omit the anchoring element 1026. In some embodiments, the engagement member 1004 is positioned posteriorly to displace all or a portion of the posterior leaflet PL, positioned anteriorly to displace at least a portion of the anterior leaflet AL, and / or positioned between the leaflets in a generally central position within the annulus.

[0078] like Figure 10 As shown, the device 1000 may also include an anterior leaflet capture element 1032, which is housed within the body of the engagement member 1004 and is configured to deploy therefrom to capture a portion of the anterior leaflet AL (e.g., a ventricular rim portion), attaching it to the engagement member 1004. For example, the leaflet capture element 1032 can be a preferably curved (e.g., U-shaped, J-shaped, C-shaped) hypotube and / or a needle operably coupled to a delivery system handle (not shown). After the engagement member 1004 has been implanted, manipulation of the delivery system handle can cause the leading end 1034 of the curved capture element 1032 to protrude outward from the distal end or inner side 1012 of the engagement member 1004, move along the transverse axis to bend around the posterior side of the anterior leaflet AL, pierce the anterior leaflet AL via the needle extending through the hypotube or the sharp portion of the leading end 1034, and extend back to the engagement member 1004. As shown Figure 10As shown, this causes the capture element 1032 to form a loop around the ventricular rim of the anterior leaflet AL, the capture element 1032 to pierce the anterior leaflet AL, and as the capture element 1032 is retracted into the coaptation member 1004, the capture element 1032 to pull the anterior leaflet AL toward the inside 112 toward or into the body of the coaptation member 1004. In various embodiments, the capture element 1032 (e.g., when the needle is omitted) does not fully pierce the native leaflet, but rather presses against the backside of the native leaflet to push it toward or into the coaptation member 1004. Thus, the device 1000 having the primary clip mechanism 1016a and the curved capture element 1032 can grasp the ends of the opposing leaflets (e.g., the posterior leaflet PL and the anterior leaflet AL) to provide an edge-to-edge effect similar to a device having 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 also include one or more additional clip mechanisms configured to capture other portions of the anterior leaflet AL and / or the posterior leaflet PL.

[0079] Further examples

[0080] The following examples illustrate several embodiments of the present technology:

[0081] 1. A valve repair device, comprising:

[0082] an atrial fixation member configured to press against heart tissue near a native valve annulus;

[0083] a coaptation member extending away from the atrial fixation member and radially inward from the atrial fixation member, the coaptation member including an inner portion having a coaptation surface configured to coapt with a first native leaflet during systole, an outer portion configured to replace at least a portion of a second native leaflet, and a downstream end portion, wherein the coaptation member is substantially stationary during a cardiac cycle; and

[0084] a plurality of clip mechanisms depending from the coaptation member, wherein each clip mechanism includes a base portion coupled to the downstream end portion of the coaptation member, a free end portion unattached to the coaptation member, and an articulable arm member extending from the base portion in an upstream direction and forming the free end portion, wherein the articulable arm member is configured to capture a portion of the first native leaflet or the second native leaflet between the articulable arm member and the coaptation member.

[0085] 2. The valve repair device of example 1, wherein the plurality of clip mechanisms includes:

[0086] a first clip mechanism extending from the exterior portion of the coaptation member and configured to capture a portion of the second native leaflet; and

[0087] a second clip mechanism extending from the interior portion of the coaptation member and configured to capture a portion of the first native leaflet.

[0088] 3. The valve repair device of examples 1 or 2, wherein the plurality of clip mechanisms comprises:

[0089] a first clip mechanism extending from the exterior portion of the coaptation member and configured to capture a central portion of the second native leaflet; and

[0090] a second clip mechanism extending from the exterior portion of the coaptation member and configured to capture a lateral portion of the second native leaflet.

[0091] 4. The valve repair device of any of the preceding examples, wherein the plurality of clip mechanisms comprises:

[0092] a first clip mechanism extending from the exterior portion of the coaptation member and configured to capture a central portion of the second native leaflet;

[0093] a second clip mechanism extending from the exterior portion of the coaptation member and configured to capture a first lateral portion of the second native leaflet; and

[0094] a third clip mechanism extending from the exterior portion of the coaptation member and configured to capture a second lateral portion of the second native leaflet.

[0095] 5. The valve repair device of any of the preceding examples, wherein the coaptation member is configured to be positioned in a mitral valve, the first native leaflet is an anterior leaflet, and the second native leaflet is a posterior leaflet, wherein the plurality of clip mechanisms comprises:

[0096] a first clip mechanism extending from the exterior portion of the coaptation member and configured to capture a P2 portion of the posterior leaflet;

[0097] a second clip mechanism extending from the exterior portion of the coaptation member and configured to capture a P3 portion of the anterior native leaflet; and

[0098] a third clip mechanism extending from the exterior portion of the coaptation member and configured to capture a PI portion of the anterior native leaflet.

[0099] 6. The valve repair device of any of the preceding examples, wherein the coaptation member is configured to be positioned in a mitral valve, the first native leaflet is an anterior leaflet, and the second native leaflet is a posterior leaflet, wherein the plurality of clip mechanisms comprises:

[0100] a first clip mechanism extending from the outer portion of the coaptation member and configured to capture a central portion of the posterior leaflet; and

[0101] a second clip mechanism extending from the inner portion of the coaptation member and configured to capture a central portion of the anterior native leaflet.

[0102] 7. The valve repair device of any of the preceding examples, wherein the fixation member is configured to position the coaptation member laterally offset from an annulus and canted toward the second valve leaflet.

[0103] 8. The valve repair device of any of the preceding examples, wherein the fixation member is configured to position the coaptation member at a central location within an annulus.

[0104] 9. The valve repair device of any of the preceding examples, wherein the fixation member comprises a plurality of interconnected struts defining a row of open cells, and wherein the fixation member is configured to engage heart tissue along a circumferential portion of a heart chamber.

[0105] 10. The valve repair device of any of the preceding examples, wherein the fixation member comprises a plurality of interconnected struts defining a row of open cells, and wherein the fixation member is configured to engage heart tissue along a non-circumferential portion of a heart chamber.

[0106] 11. The valve repair device of any of the preceding examples, wherein the fixation member forms a low-profile frame structure configured to contact a circumferential portion of a heart chamber, and wherein the low-profile frame structure comprises a connecting element affixed to the inner portion of the coaptation member.

[0107] 12. The valve repair device of any of the preceding examples, wherein the coaptation member has a crescent shape along a transverse cross-section of the annulus.

[0108] 13. The valve repair device of any of the preceding examples, wherein the coaptation member extends along a length defined by opposing commissures of the first native leaflet and the second native leaflet.

[0109] 14. The valve repair device of any of the preceding examples, wherein the fixation member comprises a tissue anchor projecting from a lower portion of the fixation member and configured to penetrate proximate the native annulus.

[0110] 15. The valve repair device of any of the preceding examples, wherein the engagement member comprises a stent structure configured to increase length between opposing commissures of the first and second native leaflets.

[0111] 16. A valve repair device according to any of the preceding examples, wherein the engagement member is configured to adjust size across a cross-sectional length.

[0112] 17. The valve repair device of Example 16, wherein the engagement member includes an expandable component to increase the width relative to the commissure line and / or the protrusion depth into the native valve orifice.

[0113] 18. The valve repair device of Example 16 wherein the engagement member is configured to receive a rod that expands the engagement member in width relative to the commissure line and / or in protrusion depth into the native valve orifice.

[0114] 19. The valve repair device according to any one of the preceding examples, wherein:

[0115] The engagement member includes a first locking feature on the inner portion; and

[0116] The plurality of clip mechanisms include-

[0117] a first clip mechanism extending from the outer portion of the engagement member and configured to capture a portion of the second native leaflet; and

[0118] A separate second clip mechanism has a second locking feature configured to cooperate with the first locking feature to attach the separate second clip mechanism to the interior portion of the engagement member.

[0119] 20. The valve repair device of Example 19 wherein the independent second clip mechanism is configured to be housed within the engagement member prior to deployment.

[0120] 21. The valve repair device of Example 19 wherein the first locking mechanism and the second locking mechanism comprise magnetic components.

[0121] 22. A valve repair device according to any of the preceding examples, wherein the engagement surface includes an actuation portion configured to open to capture a portion of the first native leaflet.

[0122] 23. The valve repair device of any of the preceding examples, further comprising a leaflet capture component housed in the coaptation member and deployable from the coaptation member and configured to penetrate and capture the first native leaflet.

[0123] 24. The valve repair device of any of the preceding examples, wherein each of the clip mechanisms comprises a spring-loaded lever configured to move the articulable arm between an open state and a closed state.

[0124] 25. The valve repair device of any of the preceding examples, wherein the articulable arm of one of the clip mechanisms comprises an annulus-underside engagement component extending from the free end portion and configured to engage annulus-underside heart tissue.

[0125] 26. A valve repair device, comprising:

[0126] a coaptation member configured to be positioned between a posterior leaflet and an anterior leaflet of a mitral valve, the coaptation member comprising-

[0127] a frame structure comprising a plurality of struts;

[0128] a covering extending along at least a portion of the frame structure and configured to form an enclosed chamber within the frame structure;

[0129] an anterior portion having a surface configured to displace or engage the anterior leaflet during systole; and

[0130] a posterior portion configured to displace or engage at least a portion of the posterior leaflet,

[0131] wherein the coaptation member is substantially stationary during a cardiac cycle;

[0132] a plurality of clip mechanisms depending from the coaptation member, wherein one or more clip mechanisms comprise-

[0133] a base portion coupled to the coaptation member,

[0134] an articulable arm member extending from the base portion in an upstream direction and having a free end portion unattached to the coaptation member, wherein the articulable arm member is configured to capture a portion of the posterior leaflet or the anterior leaflet between the articulable arm member and the coaptation member.

[0135] 27. The valve repair device of example 26, wherein the plurality of clip mechanisms comprises:

[0136] a posterior clip mechanism extending from the posterior portion of the coaptation member and configured to capture a portion of the posterior leaflet; and

[0137] an anterior clip mechanism extending from the anterior portion of the coaptation member and configured to capture a portion of the anterior leaflet.

[0138] 28. The valve repair device of either of Examples 26 or 27, wherein the plurality of clip mechanisms comprises:

[0139] a primary posterior clip mechanism extending from the posterior portion of the coaptation member and configured to capture a central portion of the posterior leaflet; and

[0140] a secondary posterior clip mechanism extending from the posterior portion of the coaptation member and configured to capture a lateral portion of the posterior leaflet.

[0141] 29. The valve repair device of Example 28, wherein the lateral portion is a first lateral portion, and wherein the plurality of clip mechanisms further comprises:

[0142] a tertiary clip mechanism extending from the posterior portion of the coaptation member and configured to capture a second lateral portion of the posterior leaflet.

[0143] 30. The valve repair device of any of the preceding Examples, further comprising an atrial fixation member coupled to the coaptation member and configured to engage cardiac tissue within a left atrium, wherein the coaptation member extends radially inward from the atrial fixation member.

[0144] 31. The valve repair device of Example 30, wherein the fixation member comprises a frame structure configured to engage cardiac tissue along a circumferential portion of the left atrium.

[0145] 32. The valve repair device of Example 30, wherein the fixation member comprises a frame structure configured to engage cardiac tissue along a non-circumferential posterior portion of the left atrium.

[0146] 33. The valve repair device of Example 30, wherein the fixation member comprises a frame structure configured to engage cardiac tissue along a non-circumferential anterior portion of the left atrium.

[0147] 34. The valve repair device of Example 30, wherein the coaptation member has a width configured to extend at least across a central sector of the posterior leaflet.

[0148] 35. The valve repair device of any of the preceding Examples, wherein the coaptation member is configured to comprise 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.

[0149] 36. The valve repair device of any of the preceding examples, wherein:

[0150] the engagement member includes a first locking feature at the anterior portion; and

[0151] the plurality of clip mechanisms includes-

[0152] an anterior clip mechanism configured to engage the anterior leaflet; and

[0153] an independent anterior clip mechanism having a second locking feature configured to mate with the first locking feature to affix the independent second clip mechanism to the interior portion of the engagement member, wherein the anterior clip mechanism is configured to engage the anterior leaflet.

[0154] 37. The valve repair device of any of the preceding examples, wherein the plurality of clip mechanisms includes:

[0155] an anterior clip mechanism configured to engage the anterior leaflet; and

[0156] an independent anterior clip mechanism configured to be housed within the engagement member and engage the anterior leaflet.

[0157] 38. The valve repair device of any of the preceding examples, further comprising a leaflet capture component housed in the engagement member and deployable from the engagement member and configured to pierce and capture the anterior leaflet.

[0158] 39. The valve repair device of any of the preceding examples, wherein each of the clip mechanisms includes a spring-loaded lever configured to move the articulable arm between an open state and a closed state.

[0159] 40. The valve repair device of any of the preceding examples, wherein the articulable arm of one of the clip mechanisms includes an annulus-underside engagement component configured to engage annulus-underside heart tissue.

[0160] 41. A method of repairing a heart valve, the method comprising:

[0161] deploying an engagement member of a valve repair device in a regurgitation orifice between a first native leaflet and a second native leaflet, wherein the engagement member has a first portion facing the first native leaflet and a second portion facing the second native leaflet, the engagement member defining an open cavity spacing the first portion and the second portion apart from one another;

[0162] extending a first articulatable arm of a first clip mechanism behind a central portion of the first native leaflet such that the central portion of the first native leaflet is between the first articulatable arm and the first portion of the coaptation member;

[0163] actuating the first articulatable arm to move to a closed state in which the first articulatable arm presses against the first native leaflet between the first articulatable arm and the first portion;

[0164] extending a second articulatable arm of a second clip mechanism behind a lateral portion of the first native leaflet or a central portion of the second native leaflet; and

[0165] actuating the second articulatable arm to move to a closed state in which the second articulatable arm clamps the leaflet portion.

[0166] 42. The method of example 41, further comprising deploying a fixation member of the valve repair device against an atrial wall such that the fixation member forms a central lumen through which blood flows around a native annulus.

[0167] 43. The method of example 41 or 42, further comprising deploying a partial fixation member of the valve repair device to engage tissue against a portion of an atrial wall.

[0168] 44. The method of any of the preceding examples, wherein:

[0169] extending the second articulatable arm of the second clip mechanism includes extending the second articulatable arm behind a lateral portion of the first native leaflet; and

[0170] actuating the second articulatable arm includes engaging the lateral portion of the first native leaflet between the second articulatable arm and the first portion.

[0171] 45. The method of example 44, wherein the lateral portion is a first lateral portion, and wherein:

[0172] extending a third articulatable arm of a third clip mechanism behind a second lateral portion of the first native leaflet; and

[0173] actuating the third articulatable arm to engage the second lateral portion of the first native leaflet between the third articulatable arm and the first portion.

[0174] 46. The method of any of the preceding examples, wherein:

[0175] extending the second articulatable arm of the second clip mechanism includes extending the second articulatable arm behind a central portion of the second native leaflet; and

[0176] Actuating the second articulatable arm includes engaging the second native leaflet between the second articulatable arm and the second portion.

[0177] 47. The method of any of the preceding examples, wherein deploying the coaptation member extends the coaptation member across at least a central sector of the first native leaflet.

[0178] 48. The method of any of the preceding examples, further comprising adjusting a width of the coaptation member across the native annulus.

[0179] 49. The method of any of the preceding examples, further comprising increasing a size of the coaptation member beyond a natural expansion of the coaptation member.

[0180] 50. The method of any of the preceding examples, further comprising deploying the second clip mechanism from within the cavity of the coaptation member.

[0181] 51. The method of example 50, further comprising locking a base portion of the second clip mechanism to a second portion of the coaptation member.

[0182] 52. The method of any of the preceding examples, further comprising:

[0183] deploying a leaflet capture component from the coaptation member; and

[0184] piercing the second native leaflet to draw the second native leaflet toward the coaptation member.

[0185] 53. The method of any of the preceding examples, further comprising engaging subannular heart tissue with a subannular engagement component extending from the first clip mechanism.

[0186] 54. The method of any of the preceding examples, wherein deploying the coaptation member of the valve repair device in the regurgitant orifice between the first native leaflet and the second native leaflet comprises deploying the coaptation member of the valve repair device in a mitral orifice between a posterior leaflet and an anterior leaflet.

[0187] Conclusion

[0188] The detailed description set forth above and the embodiments described below are not intended to constrain or restrict the technology to the form or forms disclosed. Although specific embodiments and examples of the technology are described above, those skilled in the relevant art will appreciate that many equivalent modifications and variations are possible in the scope of the technology. For example, although steps are presented in a given order, alternative embodiments can perform the steps in a different order. Various embodiments described herein can also be combined to provide further embodiments.

[0189] It will be appreciated from the foregoing that specific embodiments of the technology are described herein for purposes of illustration, but well-known structures and functions have not been shown or described in order to avoid unnecessarily obscuring the description of embodiments of the technology. Where the context permits, singular or plural terminology can also include the plural or singular aspect, respectively.

[0190] Furthermore, the word “or” is used herein in the context of describing items that are either included or not included in a list of items. Such lists are intended to include either (a) each single item in the list, (b) all of the items in the list, or (c) any combination or permutations of the items in the list. In addition, the term “comprising” means including at least one or more of the recited features, such that any more number of the same feature and / or additional types of features are not precluded. It will also be understood that, although specific embodiments have been described herein, many modifications are possible in the light of the above teaching. In addition, while advantages of certain embodiments associated with the technology have been described in the context of those embodiments, other embodiments can also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and related technology can include other embodiments not expressly shown or described herein.

Claims

1. A valve repair device, comprising: an atrial fixation member configured to press against cardiac tissue adjacent the native annulus; an engagement member extending away from the atrial fixation member and extending radially inward from the atrial fixation member, the engagement member comprising an inner portion having an engagement surface configured to engage with a first native leaflet during systole, an outer portion configured to displace at least a portion of a second native leaflet, and a downstream end portion, wherein the engagement member is substantially stationary during the cardiac cycle, and wherein the engagement member defines an interior volume and an opening to the interior volume; and a plurality of clip mechanisms depending from the engagement member, wherein each clip mechanism comprises: a base portion coupled to the downstream end portion of the engagement member, a free end portion not attached to said engaging member, an articulatable arm member extending in an upstream direction from the base portion and forming the free end portion, wherein the articulatable arm member is configured to capture a portion of the first native leaflet or the second native leaflet between the articulatable arm member and the engagement member; and an actuation mechanism configured to move the articulatable arm member between a closed position and an open position; wherein each of the actuation mechanisms is independently actuatable via a delivery member inserted through the opening in the engagement member into the interior volume of the engagement member.

2. The valve repair device according to claim 1, wherein: The plurality of clip mechanisms include: a first clip mechanism extending from the outer portion of the engagement member and configured to capture a portion of the second native leaflet; and A second clip mechanism extends from the inner portion of the engagement member and is configured to capture a portion of the first native leaflet.

3. The valve repair device according to claim 1, wherein: The plurality of clip mechanisms include: a first clip mechanism extending from the outer portion of the engagement member and configured to capture a central portion of the second native leaflet; and A second clip mechanism extends from the outer portion of the engagement member and is configured to capture a lateral portion of the second native leaflet.

4. The valve repair device according to claim 1, wherein: The plurality of clip mechanisms include: a first clip mechanism extending from the outer portion of the engagement member and configured to capture a central portion of the second native leaflet; a second clip mechanism extending from the outer portion of the engagement member and configured to capture a first side portion of the second native leaflet; and A third clip mechanism extends from the outer portion of the engagement member and is configured to capture a second side portion of the second native leaflet.

5. The valve repair device according to claim 1, wherein: The engagement member is configured to be positioned in a mitral valve, the first native leaflet being an anterior leaflet and the second native leaflet being a posterior leaflet, wherein the plurality of clip mechanisms comprises: a first clip mechanism extending from the outer portion of the engagement member and configured to capture a central portion of the second native leaflet; a second clip mechanism extending from the outer portion of the engagement member and configured to capture a medial portion of the first native leaflet; and A third clip mechanism extends from the outer portion of the engagement member and is configured to capture a side portion of the first native leaflet.

6. The valve repair device according to claim 1, wherein: The engagement member is configured to be positioned in a mitral valve, the first native leaflet being an anterior leaflet and the second native leaflet being a posterior leaflet, wherein the plurality of clip mechanisms comprises: a first clip mechanism extending from the outer portion of the engagement member and configured to capture a central portion of the second native leaflet; and A second clip mechanism extends from the inner portion of the engagement member and is configured to capture a central portion of the first native leaflet.

7. The valve repair device according to claim 1, wherein: The atrial fixation member is configured to position the engagement member laterally offset from the native valve orifice and obliquely displaced toward the second native leaflet.

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

9. The valve repair device according to claim 1, wherein: The atrial fixation member includes a plurality of interconnected struts defining rows of open cells, and wherein the atrial fixation member is configured to engage heart tissue along a circumferential portion of a heart chamber.

10. The valve repair device according to claim 1, wherein: The atrial fixation member includes a plurality of interconnected struts defining rows of open cells, and wherein the atrial fixation member is configured to engage heart tissue along a non-circumferential portion of a heart chamber.

11. The valve repair device according to claim 1, wherein: The atrial fixation member forms a low-profile frame structure configured to contact a circumferential portion of a cardiac chamber, and wherein the low-profile frame structure includes a connecting element attached to the inner portion of the engagement member.

12. The valve repair device according to claim 1, wherein: The engagement member has a crescent shape in a transverse cross-section along the native annulus.

13. The valve repair device according to claim 7, wherein: The engagement member extends along a length defined by opposing commissures of the first and second native leaflets.

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

15. The valve repair device according to claim 1, wherein: The engagement member includes a scaffold structure configured to increase length between opposing commissures of the first and second native leaflets.

16. The valve repair device according to claim 13, wherein: The engagement member is configured to adjust in size across a cross-sectional length in a direction between the first native leaflet and the second native leaflet.

17. The valve repair device according to claim 16, wherein: The engagement member includes an expandable component to increase width relative to the commissure line between the opposing commissures and / or projection depth into the native valve orifice.

18. The valve repair device according to claim 16, wherein: The engagement member is configured to receive a rod that expands the engagement member in width relative to a commissure line between the opposing commissures and / or in a projecting depth into the native valve orifice.

19. The valve repair device according to claim 1, wherein: the engagement member including a first locking feature on the inner portion; and The plurality of clip mechanisms include: a first clip mechanism extending from the outer portion of the engagement member and configured to capture a portion of the second native leaflet; and A separate second clip mechanism has a second locking feature configured to cooperate with the first locking feature to attach the separate second clip mechanism to the interior portion of the engagement member.

20. The valve repair device according to claim 19, wherein: The independent second clip mechanism is configured to be received within the engagement member prior to deployment.

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

22. The valve repair device according to claim 1, wherein: The engagement surface includes an actuation portion configured to open to capture a portion of the first native leaflet.

23. The valve repair device according to claim 1 further includes a leaflet capture component, which is housed in the engagement member and can be deployed from the engagement member and is configured to penetrate and capture the first native leaflet.

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

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

26. A valve repair device comprising: A coaptation member configured to be positioned between a posterior leaflet and an anterior leaflet of a mitral valve, the coaptation member comprising: a frame structure comprising a plurality of pillars; a cover extending along at least a portion of the frame structure and configured to form an enclosed chamber within the frame structure, wherein the cover includes an opening to the chamber; an inner portion having a surface configured to displace or engage the anterior leaflet during systole; and an outer portion configured to displace or engage at least a portion of the posterior leaflet, wherein the engagement member is substantially stationary during the cardiac cycle; a plurality of clip mechanisms depending from the engagement member, wherein one or more of the clip mechanisms comprises: a base portion coupled to the engagement member, an articulatable arm member extending in an upstream direction from the base portion and having a free end portion that is not attached to the engagement member, wherein the articulatable arm member is configured to capture a portion of the posterior leaflet or the anterior leaflet between the articulatable arm member and the engagement member; and An actuation mechanism is configured to move the articulatable arm member between a closed position and an open position, wherein the actuation mechanism is configured to be actuated via a delivery component inserted through the opening in the cover and into the cavity of the engagement member.

27. The valve repair device according to claim 26, wherein: The plurality of clip mechanisms include: a posterior clip mechanism extending from the outer portion of the engagement member and configured to capture a portion of the posterior leaflet; and An anterior clip mechanism extends from the inner portion of the engagement member and is configured to capture a portion of the anterior leaflet.

28. The valve repair device according to claim 26, wherein: The plurality of clip mechanisms include: a primary posterior clip mechanism extending from the outer portion of the engagement member and configured to capture a central portion of the posterior leaflet; and A secondary posterior clip mechanism extends from the outer portion of the engagement member and is configured to capture a lateral portion of the posterior leaflet.

29. The valve repair device according to claim 28, wherein: The side portion is a first side portion, and wherein the plurality of clip mechanisms further comprises: A tertiary clip mechanism extends from the outer portion of the engagement member and is configured to capture a second lateral portion of the posterior leaflet.

30. The valve repair device of claim 26, further comprising an atrial fixation member coupled to the engagement member and configured to engage cardiac tissue within the left atrium, wherein The engagement member extends radially inwardly from the atrial fixation member.

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

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

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

34. The valve repair device according to claim 30, wherein: The engagement member has a width configured to extend across at least a central sector of the posterior leaflet.

35. The valve repair device according to claim 26, wherein: The engagement member is configured to include an expandable structure for adjusting the width of the engagement member relative to the commissure line between opposing commissures of the anterior and posterior leaflets and / or the depth of projection into the native mitral valve orifice.

36. The valve repair device according to claim 26, wherein: the engagement member including a first locking feature on the inner portion; and The plurality of clip mechanisms include: a posterior clip mechanism extending from the outer portion of the engagement member and configured to capture a portion of the posterior leaflet; and An independent anterior clip mechanism has a second locking feature configured to cooperate with the first locking feature to attach the independent anterior clip mechanism to the inner portion of the engagement member, wherein the independent anterior clip mechanism is configured to cooperate with the anterior leaflet.

37. The valve repair device according to claim 26, wherein: The plurality of clip mechanisms include: a posterior clip mechanism extending from the outer portion of the engagement member and configured to capture a portion of the posterior leaflet; and A separate anterior clip mechanism is configured to be received within the engagement member and engage the anterior leaflet.

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

39. The valve repair device according to claim 26, wherein: Each of the clip mechanisms includes a spring-loaded lever configured to move the articulatable arm member between an open state and a closed state.

40. The valve repair device according to claim 26, wherein: The articulatable arm member of one of the clip mechanisms includes a subannular engagement component configured to engage native subannular heart tissue.

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