Systems and methods for heart valve repair

Abstract

A delivery device for a heart valve repair implant includes a delivery catheter and an elongating member projecting from a distal end of the delivery catheter. The delivery device further includes a control arm assembly having a pair of control arms. Each pair includes a proximal control arm drivable from a handle assembly of the delivery device and a distal arm coupled to a distal end of the proximal control arm and a distal end of the elongating member. Driving each proximal control arm of the control arm assembly in a proximal direction causes expansion of the control arm assembly and corresponding expansion of a heart valve repair implant coupled to the control arm assembly. TIFF2025519429000002.tif85170

Description

Technical Field

[0001] Cross - Reference to Related Applications This application is a continuation - in - part of U.S. Patent Application No. 17 / 550,660, filed on December 14, 2021, which is a continuation - in - part of U.S. Patent Application No. 17 / 227,847 (now U.S. Patent No. 11,266,502, entitled "System and Method for Cardiac Valve Repair"), filed on April 12, 2021, which is related to U.S. Patent Application No. 63 / 125,035, entitled "System and Method for Cardiac Valve Repair", filed on December 14, 2020, and claims the benefit of its priority under 35 U.S.C. § 119(e).

[0002] This application is also related to U.S. Patent Application No. 63 / 349,222, filed on June 6, 2022, and claims the benefit of its priority under 35 U.S.C. § 119(e).

[0003] The entire contents of each of the above - mentioned applications are hereby incorporated by reference in their entirety for all purposes.

[0004] Field The present disclosure relates to medical systems and methods for repairing cardiac valves. More specifically, the present disclosure relates to cardiac valve repair implants that are minimally invasive and deliverable and implantable via corresponding minimally invasive delivery tools.

Background Art

[0005] Background Cardiac valve regurgitation occurs when the cardiac valve does not close completely, so that blood leaks backward through the valve. The causes of regurgitation can be various. Functional regurgitation occurs when changes in the cardiac shape dimensions near the valve, for example, when the heart enlarges, inducing both geometric deformation around the valve annulus and insufficient leaflet coaptation during valve closure.

[0006] Regurgitation occurs due to diseases of the valve itself, for example, when the valve leaflets thicken and cannot fully close. In any case, because the high-pressure blood in the ventricle flows back through the valve into the low-pressure venous system, the patient suffers pain.

[0007] Surgical repair and replacement can treat tricuspid and mitral regurgitation with good results, but the surgery is costly and invasive. Specifically, the surgical procedure requires general anesthesia, cardiac arrest using cardiopulmonary bypass, and valve replacement or repair. The surgical procedure requires a recovery accompanied by pain for about three weeks. As a result, due to cost, recovery time, pain, and in the case of elderly patients, the risk of death, which can be too high, surgical procedures are often not performed.

[0008] Heart valves may also be repaired by percutaneous systems and methods. For example, a percutaneous procedure can navigate nitinol clips between the valve leaflets and permanently clip the leaflets together. The percutaneous clip procedure results in a relatively painless recovery within a few days, and this procedure has treated hundreds of thousands of mitral regurgitation patients with good results. Unfortunately, the percutaneous clip procedure is costly and particularly difficult for inexperienced operators. Furthermore, the feasibility of percutaneous clip procedures for the tricuspid valve has not been proven and may be less effective in the tricuspid valve. In addition, the mechanism of valve regurgitation is complex, and repairing one mechanism of the disease (for example, leaflet grasping) may temporarily reduce the severity of regurgitation but does not improve the natural course of the disease (for example, deterioration over time).

[0009] Therefore, there is a need for a system for repairing heart valves that is easy to deliver, targets several disease elements simultaneously, and improves the overall outcome compared to conventional procedures. There is also a need for a method of performing such a repair. SUMMARY OF THE INVENTION

[0010] Summary In one aspect of the present disclosure, a delivery device for a heart valve repair implant is provided. The delivery device includes a delivery catheter, an extension member protruding from a distal end of the delivery catheter, and a control arm assembly releasably couplable to the valve repair implant. The control arm assembly includes a control arm pair further including a distal control arm coupled to and extending proximally from a distal end of the extension member, and a proximal control arm coupled to the distal control arm, the proximal control arm being extendable from the distal end of the delivery catheter to expand the control arm assembly laterally.

[0011] In another aspect of the present disclosure, another delivery device for a heart valve repair implant is provided. The delivery device includes a delivery catheter, an extension member protruding from a distal end of the delivery catheter, and a control arm assembly releasably couplable to the valve repair implant. The control arm assembly includes a plurality of control arm pairs circumferentially distributed around the extension member. Each control arm pair includes a distal control arm coupled to and extending proximally from a distal end of the extension member, and a proximal control arm coupled to the distal control arm, the proximal control arm being extendable from the distal end of the delivery catheter to expand the control arm assembly laterally.

[0012] In another aspect of the present disclosure, a delivery device for a heart valve repair implant is provided. The delivery device includes a delivery catheter, an extension member protruding from a distal end of the delivery catheter, and a control arm assembly releasably couplable to the valve repair implant. The control arm assembly includes a control arm pair further including a distal control arm coupled to and extending proximally from a distal end of the extension member, and a proximal control arm coupled to the distal control arm, the proximal control arm being extendable from the distal end of the delivery catheter to expand the control arm assembly laterally. The delivery catheter further includes a distal portion including a plurality of independently operable parts. BRIEF DESCRIPTION OF THE DRAWINGS

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DETAILED DESCRIPTION OF THE INVENTION

[0135] Detailed Description For an overview of the heart valve repair system 10 disclosed herein, reference is made to FIGS. 1A-1D. In particular, FIG. 1A is a photograph of the heart valve repair system 10, and FIGS. 1B-1D are isometric, plan, and side views, respectively, of the valve repair system 10. As can be seen from FIG. 1A, the system 10 includes a delivery and deployment tool 15 and an implantable heart valve repair device or implant 20 supported at the distal end 25 of the tool 15. The tool 15 includes a proximal end 30 opposite the tool distal end 25. The tool proximal end 30 includes a control handle 35, which is used by a physician to manipulate the tool 15 when positioning the implant 20 at a target site and deploying the implant 20 within the target site, which is the heart valve requiring repair, as will be described later in this "Detailed Description". In one aspect, the tool 15 is used for minimally invasive delivery and deployment of the implant 20 within the heart valve requiring repair.

[0136] The system and its implant are advantageously such that the implant can be delivered and deployed to the target site via an antegrade percutaneous route (e.g., the transfemoral arterial route or the transjugular venous route) while the patient is in conscious sedation during the procedure. The implantation stage is expected to take less than 60 minutes, and the implant and delivery system are expected to require substantially lower costs than conventional heart valve repair systems. Finally, the regurgitation grade provided by the heart valve repair accomplished by the implant 20 disclosed herein is 2+ or less. Thus, the heart repair system 10 represents a significant improvement over prior art systems as it is non-invasive, substantially less expensive, requires less time, and all of these provide a significant improvement in reducing regurgitation.

[0137] I. Heart Valve Repair Implant To begin a detailed description of the heart valve repair implant 20, reference is made to FIGS. 2-6, which are various views of the implant 20 in an expanded state when implanted into the heart valve to be repaired. As shown in these figures, the implant includes a distal end 40 and a proximal end 45. The distal end 40 serves as the tip of the implant 20 during implantation, as can be seen from FIGS. 1A-1D.

[0138] As shown in FIGS. 2-6, the implant 20 further includes a central closure plug 50, a frame 55, and a thin sheet 60 (also referred to herein as a thin layer 60) supported on the frame. The frame 55 extends proximally from the proximal end 65 of the central closure plug 50. In the expanded state, the frame 55 radially expands outwardly with respect to the central longitudinal axis (longitudinal axis) 70 of the implant 20 (see FIG. 5), and the thin sheet 60 forms an annular surface 62 supported on the expanded frame 55. The annular surface 62 has a distal radially inner edge 63 and a proximal radially outer edge 64. The distal radially inner edge 63 defines a central opening 66 in the thin sheet 60 and the implant 20. The proximal radially outer end 64 forms the most proximal radially outer boundary of this aspect of the implant in the expanded state. The central longitudinal axis 70 passes through the most distal end 75 of the central closure plug 50 and the center point 80 (see FIG. 4) of the proximal end 65 of the central closure plug. In view of the foregoing, in at least certain aspects, the frame 55 is generally designed to seat on the floor of the atrium, induce annulus reduction, and form a neo-annulus.

[0139] As can be seen from FIGS. 2-6, in addition to being annular, the annular surface 62 is conical or relatively conical (e.g., parabolic), and when the implant 20 is implanted in the target heart valve as shown in FIG. 10, its proximal side facing the atrial chamber may function as a funnel structure that leads distally from the atrium to the central opening 66 of the implant 20 and a valve opening distal to the central opening 66. Similarly, as can be seen from FIG. 10, the distal side of the annular surface 62 is also conical and may generally form a mating surface contact with the semi-conical region of the atrial wall surface and the circumferential annular region around the target heart valve.

[0140] FIG. 7 is a side view of the implant in a folded state to enable its delivery to the target site via the tool 15. When in the folded state as shown in FIG. 7, the frame 55 and the thin sheet 60 are folded symmetrically about the central longitudinal axis 70. Thus, a comparison of the implant 20 in FIGS. 2-6 in the expanded state with the implant 20 in FIG. 7 in the folded state shows that the implant can transition from the folded state to the expanded state like an umbrella.

[0141] As can be seen from FIG. 9 and as will be described in more detail later in this "Detailed Description", during delivery, the implant 20 is maintained in the folded state of FIG. 7 by the tool 15 to prepare for implantation of the implant into the target heart valve and to allow the implant to pass through the patient's vasculature and enter the atrium. For example, with the implant 20 maintained in the folded state by being confined within the tubular sheath 76 of the delivery tool 15, the implant can be delivered to and deployed at the target site via an antegrade percutaneous route (e.g., the transfemoral artery route or the transjugular vein route) while the patient is in a conscious sedated state during the procedure.

[0142] As can be seen from FIG. 1A, when properly positioned within the target heart valve for repair, the physician actuates the tool 15 such that the tool no longer maintains the implant 20 in the collapsed state. Since the frame 55 of the implant 20 is biased to self-expand to the expanded state shown in FIGS. 2-6, the implant self-expands to the expanded state and fixes itself within the target heart valve to reduce backflow, as shown in FIG. 10.

[0143] Returning to FIGS. 2-6, it can be seen that the central occluder 50 can take the form of a bullet or cone. In that case, the central occluder can have a cylindrical side surface 85 that extends distally from the central occluder proximal end 65 and then transitions to a bulbous nose 90 (extending distally to the central occluder distal most end 75). Such a bullet or cone shape results in a central occluder 50 that is atraumatic for delivery and implantation purposes. Further, such a shape facilitates the cylindrical side surface 85 of the central occluder to substantially seal the heart valve leaflet, thereby substantially reducing, if not eliminating, the central backflow through the heart valve leaflet.

[0144] Non-limitingly, depending on the aspect, the central occluder 50 can be formed from polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), acetal, silicone, nylon, polyethylene, polypropylene, polyethylene terephthalate (PET), polyurethane, or other thermoplastic elastomers. In certain aspects, the material of the central occluder 50 may be angiogenic and / or echolucent.

[0145] In certain embodiments, the central occluder 50 may be filled with saline, a mixture of saline and a radiopaque contrast agent, or other fluid. In such embodiments, the central occluder 50 may be delivered in a first form with a reduced diameter and then expanded to a second form with an increased diameter after delivery by introducing fluid. The amount of saline delivered during implantation can be determined in real-time, for example, by monitoring the size of the central occluder 50 using, for example, X-ray images, and / or by monitoring a reduction in backflow using, for example, ultrasound imaging.

[0146] In certain embodiments, and without limitation, the central occluder 50 can be formed from a material having a durometer value of 10A to 100D, 10D to 100D, or 40D to 80D. In one specific embodiment, the material of the central occluder 50 has a durometer value of 80D. As shown in FIG. 5, the central occluder can have an overall diameter DO that, in certain embodiments and without limitation, can be from about 5 millimeters (mm) to about 25 mm, from about 5 mm to about 15 mm, or from about 8 mm to about 12 mm. The central occluder 50 can further have an overall length LO that, in certain embodiments and without limitation, can be from about 5 mm to about 40 mm or from about 10 mm to about 20 mm, from its proximal end 65 to its most distal end 75. The bulbous nose 90 can have a length LB that, in certain embodiments and without limitation, can be from about 2.5 mm to about 12.5 mm, from about 2.5 mm to about 7.5 mm, or from about 4 mm to about 6 mm. In certain embodiments, and without limitation, the radius of curvature R of the bulbous nose 90 can be from about 2.5 mm to about 12.5 mm, from about 2.5 mm to about 7.5 mm, or from about 4 mm to about 6 mm. The overall shape of the bulbous nose 90 can also vary from embodiment to embodiment. For example, the bulbous nose 90 can have any of a parabolic profile, a conical profile, a spherical profile, or other non-traumatic profile. In other exemplary embodiments, the bulbous nose 90 can have a triangular or trilobal shape with surfaces for sealing each valve tip. In yet another example, the central occluder 50 can have a rounded bi-concave shape. In still other embodiments, the central occluder 50 can be configured to allow expansion of the distal portion of the frame 55, thereby facilitating reintervention (e.g., valve implantation). In still other embodiments, the central occluder 50 can include a flexible material, such as, without limitation, a frame (e.g., inner struts) covered with expanded polytetrafluoroethylene (ePTFE), polyester fabric, or similar materials. In such embodiments, the flexible cover can allow the central occluder 50 to be compressed during delivery but expand to close the valve and reduce backflow once placed within the native valve.

[0147] As can be seen from FIG. 5, in one aspect, the central closure plug 50 can have an overall diameter DO of about 10 mm and an overall length LO of about 16 mm. Additionally, the bulbous nose 90 can have an overall length LB of about 5 mm, and the radius of curvature of the bulbous nose 90 may or may not gradually transition from proximal to distal over its length LB. For example, the radius of curvature R can have a maximum value of about 2.5 mm to about 15 mm as measured from the center of curvature C to the distal end 75 of the central closure plug 50, but transitions to a radius of curvature R of about 2.5 mm to about 10 mm (but less than the maximum value) at a location near the distal end 75. However, in one aspect, the bulbous nose 90 may have a constant radius of curvature of about 5 mm.

[0148] As can be seen from FIGS. 2 - 6, the thin sheet 60 is supported and fixed on the frame 55. For example, and without limitation, in certain aspects, the thin sheet 60 can be fixed to the frame 55 by stitching a skirt portion to the inner and / or outer surface of the frame 55. In other embodiments, the thin sheet 60 can include a cuff or similar folded structure that is folded back over the end of the frame 55. In yet other embodiments, the thin sheet 60 can be fixed to the frame by stitching, welding, adhesion / sticking, stapling or any other suitable fixing method or combination of fixing methods. Depending on the aspect, the thin sheet 60 can be on the distal side, proximal side or both sides of the frame 55 such that the frame extends through and along the thin sheet. In one aspect, when the implant 20 is implanted in the target heart valve, the distal side of the frame where the frame contacts the atrial tissue is covered by the thin sheet 60.

[0149] Depending on the embodiment, the thin sheet 60 can be formed from, or include, a woven or knitted fabric or cloth that promotes in-growth of tissue. The porosity of the cloth of the thin sheet 60 helps to reduce cross-linked tricuspid regurgitation. Further reduction of cross-linked tricuspid regurgitation is provided by the angulation of the frame 55 that provides circumferential closeness to the cross-links. For example, when the implant 20 is implanted in the target heart valve, in-growth of tissue into the cloth of the thin sheet 60 helps to reinforce the myocardium and prevent further expansion of the tissue, reducing the risk of future regurgitation.

[0150] The cloth can be made in a variety of ways, namely braiding, weaving, single layer or multi-layer. These cloths can be laminated with a polymer to produce a composite structure, namely a two-piece knitted fabric (high porosity) having a polymer coating such as silicone or urethane. Exemplary materials for the woven or knitted fabric include, but are not limited to, polyester, polypropylene, polyethylene, etc. The thin layer 60 can have a material thickness of about 0.03 mm to about 1 mm, about 0.05 mm to about 0.2 mm or about 0.07 mm to about 0.12 mm. In one exemplary embodiment, the thickness of the thin layer 60 is about 0.2 mm. In another exemplary embodiment, the thickness of the thin layer 60 is about 0.55 mm. In one embodiment, an additional woven layer may be added proximal to the thin sheet 60 to form a smooth surface for minimizing thrombus formation at the location adjacent to the heart valve in the atrium where the implant 20 is implanted.

[0151] As shown in FIGS. 5, 6 and 7, the thin sheet 60 has an outer diameter DS. In certain embodiments, the outer diameter DS can be from about 40 mm to about 80 mm, from about 50 mm to about 70 mm, or from about 55 mm to about 65 mm. The thin sheet 60 has a radial width RW. In certain embodiments, the radial width RW can be from about 10 mm to about 30 mm, from about 13 mm to about 23 mm, or from about 17 mm to about 19 mm. The thin sheet 60 has a central opening 66 with an inner diameter DI. In certain embodiments, the inner diameter DI can be from about 20 mm to about 60 mm, from about 25 mm to about 45 mm, or from about 28 mm to about 32 mm. For example, in one embodiment, the thin sheet 60 has an outer diameter DS of about 60 mm, a radial width RW of about 18.2 mm, and a central opening 66 with an inner diameter DI of about 30 mm. With this configuration, when the implant 20 is implanted in the target heart valve, the circumferential cloth of the thin sheet 60 covers a part of the outer valve leaflet commissure to block leakage at the edge of the commissure.

[0152] As shown in FIGS. 2-6, the frame 55 includes spokes 95, an arcuate petal-like portion 100, and protruding anchor members 105. The frame 55 can be made from a variety of superelastic and / or shape memory materials, such as nickel-titanium alloys (e.g., nitinol), which may be laser cut from tubing or in the form of drawn wire. The profile defined within the shape memory material can be defined therein by various cutting methods known in the art, including lasers, water jets, electrical discharge machining (EDM), stamping, etching, milling, etc.

[0153] In one embodiment, the frame 55 is made of a superelastic shape memory nickel-titanium alloy (e.g., nitinol). Regardless of which shape memory material is used, the shape memory aspect of the frame 55 enables the frame and, as a result, the implant 20 to bias itself from a collapsed state (see FIG. 7) to an expanded state (see FIGS. 2-6) when the frame and the implant 20 are not physically maintained in the collapsed state by the delivery tool 15.

[0154] In various aspects, the frame 55, the central closure plug 50, and the remainder of the implant 20 remain implanted as a unit within the target heart valve. In other words, the implant 20 can be implanted and remain as shown in the configurations of FIGS. 2 - 6.

[0155] There may be situations where it is desirable to remove the central closure plug and then implant a replacement valve into the target heart valve. Thus, in an alternative aspect, after implantation, the central closure plug 50 and the frame spokes or struts 95 can be removed, leaving the circumferential annular surface 62 of the implant in place, which is formed by and includes the arcuate leaflet - like portion 100 of the frame and the thin sheet 60 supported thereon. In such an aspect, a circumferential suture connection may exist between the spoke 95 and the remaining portion of the frame 55 radially outside the spoke 95. Thus, cutting this circumferential suture connection and passing the central closure plug 50 and its spoke 95 through a catheter and removing them, leaving the annular portion of the implant, can cause it to function as an "annuloplasty" frame thereafter.

[0156] As shown in FIG. 7, when the implant 20 is in the folded state, the spoke 95 extends proximally from the proximal end 65 of the central closure plug 50 to the arcuate leaflet - like portion 100. At that time, the spoke 95 extends substantially parallel to and along the central longitudinal axis 70 of the implant 20 and near it. As can be seen from FIG. 7, when the implant is in the folded state, each spoke 95 has a length L from the proximal end 65 of the central closure plug to the distal boundary of the arcuate leaflet - like portion 100. In certain aspects, the length L can be from about 10 mm to about 40 mm or from about 15 mm to about 22 mm, and in one aspect, the length L is about 19 mm. Thus, as shown in FIG. 7, the frame 55 in the folded state has an overall length OL that is the sum of the length L (shown in FIG. 7) and the radial width RW (shown in FIGS. 5 and 7), and the candidate dimensions for the radial width RW are as described above with respect to FIG. 5.

[0157] As shown in FIGS. 2 to 6, when the implant 20 is in the expanded state, the spoke 95 extends proximally from the proximal end 65 of the central closure plug and radially spreads laterally (outwardly) from the central longitudinal axis 70 of the implant 20 to the arcuate petal-like portion 100. At that time, the spoke 95 has a radius of curvature RC of about 5 mm to about 20 mm, about 10 mm to about 18 mm or about 15 mm to about 16 mm, and in one aspect, as can be taken from FIG. 5, has a radius of curvature RC of about 15 mm.

[0158] Depending on the embodiment, the frame 55 can include from about 3 to about 15 spokes 95. In certain embodiments, the number of spokes 95 and the spacing between them can be selected to facilitate the passage of other tools and devices through the frame 55. Embodiments can include spokes 95 of various cross-sectional shapes; however, at least in certain embodiments, the spokes 95 have an annular sector cross-sectional shape as shown in the insert A-A of FIG. 6. In such embodiments, the cross-sectional shape of the spokes 95 can be determined by the strut width SW (defined as the maximum width of the spoke) and the wall thickness WT of the spokes 95, respectively. The spokes 95 can further be determined by the cross-sectional radius of curvature CSR measured with respect to the centerline CL of each spoke. In certain embodiments, the wall thickness WT can be from about 0.2 mm to 0.8 mm, from about 0.3 mm to about 0.7 mm, or from about 0.4 mm to about 0.6 mm. Additionally, in certain embodiments, the spokes 95 can conform to a specific spoke aspect ratio that refers to the ratio of the wall thickness WT to the strut width SW with respect to the spokes 95. For example, without limitation, embodiments can have a spoke aspect of 4:0.5 to 1:2, 3:1 to 1:1.2, or 2:1 to 1:1. In embodiments, the cross-sectional radius of curvature CSR can be from about 2 mm to about 6 mm, from about 3 mm to about 5 mm, or from about 3.5 mm to about 5 mm. In one particular embodiment, the frame 55 is made of nitinol, the frame 55 has 12 spokes 95, and each spoke 95 has a wall thickness WT of about 0.46 mm, an aspect ratio of about 2:1 (resulting in a strut width SW of about 0.23 mm), and a cross-sectional radius of curvature CSR of about 5 mm. In certain embodiments, the spokes 95 can be arranged to extend distally from the frame 55 at an angle such that the thin sheet 60 closes the joining gap. In certain embodiments of the present disclosure, each of the spokes 95 can be dimensionally identical; however, in other embodiments, one or more of the spokes 95 can differ in any of the various features described above.

[0159] As shown in FIGS. 2-6, each arcuate petal-shaped portion 100 is located between a pair of spokes 95 and forms a segment of the circumference of the outer half in the radial direction of the expanded frame 55. As can be seen from FIG. 5, unlike the spokes 95 that are curved in the expanded state, the arcuate petal-shaped portion 100 in the expanded state is substantially straight in the direction of spreading radially in the lateral direction and has a radial width RW substantially the same as that of the thin sheet 60. Each petal-shaped portion 100 has an outer arcuate member 110 and an inner arcuate member 115, both of which point radially outward. These arcuate members 110, 115 intersect at a joint portion 120 extending from their respective spokes 95 and surround an anchor member 105 protruding distally from the distal side of the joint portion 120.

[0160] Depending on the aspect, the frame 55 may include a different number of petal-shaped portions 100. For example, in certain exemplary aspects, the frame 55 may include 3 to 18 petal-shaped portions 100, 6 to 15 petal-shaped portions 100, or 10 to 14 petal-shaped portions 100. In one aspect, the frame 55 has 12 petal-shaped portions 100. Similarly, the frame 55 may include a different number of protruding anchor members 105. For example, in certain exemplary aspects, the frame 55 may include 6 to 60 protruding anchor members 105, 12 to 36 protruding anchor members 105, or 18 to 30 protruding anchor members 105. In one aspect, the frame 55 has 24 protruding anchor members 105.

[0161] The frame 55 engages the atrial tissue via protruding anchor members 105 that may be in the form of small barbs. The protruding anchor members 105 are designed to securely engage the atrial tissue without penetrating the tissue or the coronary blood vessels. Depending on the aspect, the protruding anchor members or barbs 105 may be curved to slide before engaging the tissue. There may be one row or multiple rows of retention barbs 105.

[0162] As shown in the enlarged view of the joint portion 120 of FIG. 6, each protruding anchor member 105 is defined in the surrounding joint portion 120 such that the anchor member 105 is peninsula-shaped via a slot 125 extending around the protruding anchor member 105. The radially inner end 105A extends without interruption to the remainder of the surrounding joint portion 120 and is on the side opposite the radially outer free end 105B of the anchor member 105, and the radially outer free end 105B forms the tip of the protruding anchor member 105. As can be seen from FIGS. 2, 3, and 5, the radially outer free end of the anchor member projects distally from the remainder of the frame 55.

[0163] Depending on the aspect, each protruding anchor member 105 may have a length of from about 0.5 mm to about 6 mm, from about 1 mm to 4 mm or from about 1 mm to about 3 mm. Similar to the spoke 95, the protruding anchor member 105 may have various cross-sectional shapes. In at least certain aspects, the protruding anchor member 105 has an annular sector cross-sectional shape, as described above with respect to the spoke 95 and as shown in the insert view A-A of FIG. 6 referenced for the following description. Similar to the spoke 95, the cross-sectional shape of the protruding anchor member 105 may be determined by the strut width SW (defined as the maximum width of the spoke) and the wall thickness WT, respectively. The protruding anchor member 105 may further be determined by the cross-sectional radius of curvature CSR measured with respect to the centerline CL of each anchor member. In certain embodiments, the wall thickness WT may be from about 0.2 mm to 0.8 mm, from about 0.3 mm to about 0.7 mm or from about 0.4 mm to about 0.6 mm. Additionally, in certain embodiments, the protruding anchor member 105 may conform to a specific aspect ratio between the wall thickness WT and the strut width SW. For example, without limitation, the protruding anchor member 105 according to certain aspects may have an aspect ratio of 4:0.5 to 1:2, 3:1 to 1:1.2 or 2:1 to 1:1. In certain aspects, the cross-sectional radius of curvature CSR may be from about 2 mm to about 6 mm, from about 3 mm to about 5 mm or from about 3.5 mm to about 5 mm. Each protruding anchor member 105 has a wall thickness WT of about 0.46 mm, an aspect ratio of about 2:1 (resulting in a strut width SW of about 0.23 mm), a cross-sectional radius of curvature CSR of about 5 mm and a length of about 1.5 mm. In certain aspects of the present disclosure, each of the protruding anchor members 105 may be dimensionally identical; in other aspects, one or more of the protruding anchor members 105 may differ in any of the various features described above.

[0164] In one aspect, as can be seen from FIGS. 2, 3, and 5, the projecting anchor member or barb 105 is directed distally and radially outward. As a result, when the frame 55 is pushed toward the ventricle, the anchor member 105 slides along the atrial tissue. When the intraventricular pressure pushes the implant 20 toward the atrium and embeds the anchor or barb 105 into the atrial tissue.

[0165] In an alternative aspect, the anchor or barb 105 is reversely directed so as to project distally and radially inward. In this alternative aspect, when the delivery system overextends the frame 55 during delivery and the frame is released from the delivery system while the frame 55 is in contact with the tissue, the anchor or barb 105 engages the atrial tissue when the frame 55 contracts to its relaxed state.

[0166] II. Delivery Tool and Implantation Method As shown in FIGS. 1A - 1D, the delivery tool 15 includes a proximal end 30, a distal end 25 opposite the proximal end, a control handle 35, a tubular sheath 76, and a catheter 77. The control handle 35 extends distally from the proximal end 30 and is used by a physician to manipulate the tool 15 when positioning the implant 20 at the target site and deploying the implant 20 within the target heart valve that requires repair. The sheath 76 and the catheter 77 extend distally from the control handle 35 toward the distal end 25 of the tool 15. The catheter 77 extends longitudinally (in the longitudinal direction) through the sheath 76, and the distal end 25 of the catheter 77 forms the distal end 25 of the tool 15. The sheath 76 is used to minimize tissue damage when the catheter 77 and the implant 20 are advanced to the implantation site. Thus, the delivery tool 15 is designed to deliver the implant 20 to the implantation site, place it within the target heart valve, and control the opening of the frame 55 of the implant 20 (in a non-invasive manner).

[0167] As shown in FIG. 8, which is an enlarged view of the distal region of the heart repair system 10 of FIG. 1A, the suture 130 extends between the distal region of the catheter 77 and the connection point on the frame 55 of the implant 20. The suture 130 further extends from the distal region of the catheter to the handle 35 and, in one embodiment, may extend outside the handle as shown in FIG. 1A. Depending on the embodiment, the control suture 130 can also be replaced by a cable or wire.

[0168] As can be seen from FIGS. 1A and 8, before the implant 20 is fully released from the delivery tool 15, the suture 130 can be manipulated via the handle 35 of the tool 15 to control the opening of the implant frame 55. The actuation of the suture can have one or two speeds which can be in low and / or high speed forms. The low speed can be controlled by a spool mechanism or a lead screw mechanism 135 within the handle. The high speed can be controlled by a plunger-type linear actuator 140 within the handle. The suture 130 can be routed within the handle 35 to provide a 2:1 mechanical advantage to facilitate improved control accuracy when deploying the implant 20.

[0169] The catheter 77 can use steering via selective actuation (e.g., tension increase or decrease) of a particular suture to better control the position of the implant during deployment. This steering mechanism can be controlled at the handle 35.

[0170] FIG. 9 is a side cross-sectional view of the sheath 76 of the delivery tool 15 having the implantable heart valve repair implant 20 and the distal region of the catheter 77 positioned therein. As can be seen from FIG. 9, during delivery, the implant 20 is maintained in a folded state by being confined within the sheath 76 and is coupled to the distal end of the catheter 77 extending through the sheath 76. The control suture 130 is not shown in FIG. 9 for clarity, but as can be seen from FIGS. 1A and 8, it will extend through the catheter 77 and / or the sheath 76.

[0171] When the implant 20 is maintained in a folded state by being confined within the sheath 76 of the delivery tool 15, the implant can be delivered to and deployed at the target site via an antegrade percutaneous route (e.g., a transfemoral artery route or a transjugular vein route) while the patient is in a conscious sedation state during the procedure. The distal end 25 of the catheter 77 is coupled to the proximal end 65 of the central closure plug 50 to maintain the implant 20 in a folded state within the sheath 76 until the physician determines to deploy the implant within the target heart valve.

[0172] When the implant is correctly positioned in the atrium and begins to approach the target heart valve for repair, the physician activates the tool 15 to cause the catheter 77 to act as a plunger and / or a stopper, thereby driving the folded implant 20 distally out of the restraint of the sheath 76 and / or withdrawing the sheath 76 proximally away from around the implant 20. When the folded implant 20 is exposed by the action of exiting the distal end 129 of the sheath, the implant 20 self - biases to its expanded state as shown in FIGS. 2 - 6. However, as shown in FIG. 8, even though it exits the sheath distal end 129 and assumes an expanded state, the proximal end 65 of the central closure plug 50 of the implant 20 remains coupled to the distal catheter end 25, and the implant frame 55 is coupled to the suture 130, thereby enabling the physician to use the delivery tool 15 to push the implant into the target valve and manipulate the implant for implantation therein.

[0173] The configuration of the implant 20 facilitates a very simple and rapid delivery and implantation. Thereby, the ease of delivery of the implant is promoted, and generally the user only needs to roughly center the frame and push it into the valve.

[0174] When the implant 20 reaches the atrium and the target heart valve, the physician simply uses the tool 15 to activate the suture 130, enabling the frame 55 to self - bias in a controlled manner and open above the atrial side of the target heart valve. Then, the catheter 77 of the tool 15 is used to push the implant 20 toward the ventricle, engaging the frame barb 105 into the atrial tissue surrounding the target heart valve. If necessary, the control suture 130 can be used to fold the frame 55 of the implant 20 to facilitate repositioning of the implant. When the implant is fully implanted as desired by the physician, the exposed end of the control suture 130 is cut near the fixed point to the implant frame 55, and the distal catheter end 25 is released from the proximal end 65 of the central closure plug 50 (e.g., unscrewing or disconnecting in another way). When the tool 15 is thus detached from the implanted implant, the tool can be removed from the patient.

[0175] Figure 10 is a view of the implant 20 implanted in the target heart valve, looking from the atrial position in the direction of the valve and ventricle below. As shown in Figure 10, when implanted in the target heart valve, the implant secures itself within the target heart valve and is configured to reduce backflow in the target heart valve. When implanted, the implant 20 is positioned on the atrial side of the target heart valve. The frame engages the atrial tissue via small barbs 105. A thin sheet 60 supported on the frame 55 forms an annular surface 62 supported on the expanded frame 55. This annular surface 62 extends circumferentially across the atrial tissue around the target heart valve. The central closure plug 50 is suspended from the frame 55 and is positioned at the center of the valve orifice or opening. When arranged in such a way, the implant provides the following advantages and reduces backflow through multiple mechanisms of action.

[0176] First, the metal frame 55 supports the central closure plug 50 positioned to block central leakage of the target heart valve, thereby reducing the central backflow passing through the target heart valve. Specifically, the central closure plug can block some or all of the central backflow in the valve.

[0177] Second, a thin sheet 60 covering the frame 55 promotes ingrowth into the atrium and annulus tissue surrounding the target heart valve. Such tissue ingrowth allows the thin sheet and its support frame 55 to act as an annuloplasty ring, reinforcing native tissue and reducing myocardial stretch that can increase the risk of regurgitation.

[0178] Third, the thin sheet 60 covering the frame 55 may overlap the edges of the leaflet commissures, reducing the risk of commissural leakage.

[0179] Finally, the frame 55 may be over-expanded prior to engaging the anchoring barb 105 into the tissue. Relaxing the frame reduces the orifice of the target heart valve, improving leaflet coaptation and thereby reducing or eliminating regurgitation.

[0180] III. Operable Delivery Tool Figures 11A and 11B are a plan view and a side view, respectively, of an alternative valve repair system 1100 according to the present disclosure. Similar to the valve repair systems described previously herein, the valve repair system 1100 is generally configured to deliver and deploy an implant 20 to a target site within a heart valve generally in need of repair. Aspects of the valve repair system 1100 may be used with any implant detailed herein or otherwise consistent with the present disclosure, but are not so limited.

[0181] As shown in FIGS. 11A-11B, the valve repair system 1100 includes a delivery tool 1115. The delivery tool 1115 includes a proximal end 1130 opposite the tool distal end 1125. The delivery tool 1115 further includes a tubular sheath 1176 and a catheter 1177. The control handle 1135 extends distally from the proximal end 1130 and is used by a physician to manipulate the tool 1115 when placing the implant 20 at a target site and deploying the implant 20 within the target heart valve requiring repair. The sheath 1176 and catheter 1177 extend distally from the control handle 1135 toward the distal end 1125 of the tool 1115. The catheter 1177 extends longitudinally through the sheath 1176, and the distal end 1125 of the catheter 1177 forms the distal end 1125 of the tool 1115. The sheath 1176 is used to minimize tissue damage when the catheter 1177 and implant 20 are advanced to the implantation site. Thus, the delivery tool 1115 is designed to deliver the implant 20 to the implantation site, place it within the target heart valve, and control the opening of the implant 20 (in all non-invasive ways).

[0182] To facilitate delivery of the implant 20 to the implantation site, the catheter 1177 of the tool 1115 may be maneuverable. For example, in the specific embodiments shown in FIGS. 11A and 11B, the control handle 1135 of the tool 1115 includes a bidirectional steering control mechanism 1180 that may be rotatable to steer the distal end 1125 of the tool 1115. As shown in FIG. 11C, the steering control mechanism 1180 rotates between two ranges indicated by the dashed outlines 1190A, 1190B and can steer the distal end 1125 between corresponding ranges indicated by the dashed outlines 1192A, 1192B. In the illustrated specific example, the steering control mechanism 1180 facilitates steering of the distal end 1125 over a range of motion of approximately 180°. In other words, the steering control mechanism 1180 can rotate the distal end 1125 between a first position where the distal end 1125 faces a first lateral direction (outward direction) and a second position where the distal end faces a second lateral direction (outward direction) opposite the first lateral direction.

[0183] In certain embodiments, manipulation of the distal end 1125 is achieved by coupling the manipulation control mechanism 1180 to a manipulation segment 1182 disposed along the catheter 1177 and distal to the manipulation control mechanism 1180. More specifically, the manipulation control mechanism 1180 may include cross-members 1184A, 1184B, each of which is coupled by a respective pull wire 1186A, 1186B to opposite sides of the distal end of the manipulation segment 1182. Thus, when the manipulation control mechanism 1180 is rotated, the corresponding pull wire is pulled and the manipulation segment 1182 is bent in the same direction. For example, referring to FIG. 11C, as shown by the dashed outline 1190A, when the manipulation control mechanism 1180 is rotated counterclockwise with respect to the view of FIG. 11C, the cross-member 1184A pulls the pull wire 1186A, and as a result, the distal end 1125 curls in the counterclockwise direction, as shown by the dashed outline 1192A. Similarly, as shown by the dashed outline 1190B, when the manipulation control mechanism 1180 is rotated clockwise with respect to the view of FIG. 11C, the cross-member 1184B pulls the pull wire 1186B, and as a result, the distal end 1125 curls in the clockwise direction, as shown by the dashed outline 1192B.

[0184] The manipulation segment 1182 can take various forms; generally, it is a flexible and manipulable segment of the catheter 1177 or a separate sleeve or sheath coupled to the catheter 1177. In certain embodiments, for example, the manipulation segment 1182 can be a sleeve or a portion of the catheter 1177 formed from a flexible material. In other embodiments, the manipulation segment 1182 may be segmented or otherwise include slits, notches or similar voids along its length to provide flexibility. In one specific embodiment, the manipulation segment 1182 may have a helical shape. In yet other embodiments, the manipulation segment 1182 may be a segment of the catheter 1177 having a reduced wall thickness. The foregoing are merely examples and other techniques for forming the manipulation segment 1182 that may be used are also contemplated.

[0185] In certain embodiments, pull wires 1186A, 1186B extend within an annular space defined between sheath 1176 and catheter 1177. Alternatively, pull wires 1186A, 1186B may be passed through a lumen defined within a wall of catheter 1177, within a wall of sheath 1176, or within a third annulus disposed along the distal length of tool 1115. For example, catheter 1177 or an additional tubular sheath disposed between catheter 1177 and sheath 1176 may be formed as a three-lumen extrusion including a central lumen and a pair of smaller lumens (through which pull wires 1186A, 1186B extend) disposed on either side of the central lumen.

[0186] Although shown in FIG. 11C as having a 180° range of motion, aspects of the present disclosure may be configured to have other ranges of motion. For example, certain embodiments may be configured to rotate distal end 1125 360°, e.g., from a first position where distal end 1125 faces a first side of tool 1115 in a proximal direction to a second position where distal end 1125 also faces a second side of tool 1115 that is opposite the first side in the proximal direction. In other embodiments, distal end 1125 may have a reduced range of motion, such as, without limitation, 135°, 90°, 45°, or 15°. Additionally, although the range of motion shown in FIG. 11C is shown as being substantially equal in both directions, aspects of the present disclosure may have a range of motion that is unequal in different directions. For example, a tool having a 135° range of motion may move 90° in a first direction but only 45° in a second direction opposite the first direction. Moreover, tool 1115 has a neutral position where catheter 1177 is substantially straight, but catheter 1177 may alternatively be configured to have a bias in a particular direction.

[0187] IV. Implants Having Tension Control Lines FIG. 12 is a distal plan view of the implant 20 in an extended state incorporating the tension control line 200. As described above with respect to FIGS. 2-6, the implant 20 generally includes a central closure plug 50, a frame 55, and a thin sheet 60 supported on the frame 55. Further details regarding the components and structure of the implant 20 and the frame 55 were provided previously with respect to FIGS. 2-6.

[0188] As shown in FIG. 12, the tension control line 200 can be in the form of a wire, suture, cord, or similar elongate body that is coupled to the frame 55 radially inward of the thin sheet 60 with respect to the longitudinal axis 70 (shown in FIG. 5) of the implant 20. The tension control line 200 can form a loop that extends around the frame 55 and can be formed from a single wire, suture, etc. In other embodiments, the tension control line 200 may instead be formed from a plurality of separate segments of wire, suture, etc., each separate segment being coupled to the frame 55 and optionally also to adjacent segments of the control line 200.

[0189] During operation, and more specifically during deployment of the implant 20, the tension control line 200 is releasably coupled to a tension control member (e.g., tension control member 320 shown in FIGS. 13-22 and described in further detail below) of a delivery tool (e.g., delivery tool 300 shown in FIGS. 13-22 and described in detail below). The tension control member can be coupled to a handle of the delivery tool or a similar operable component (e.g., handle 35 of tool 15 described above) to vary the tension applied to the tension control line 200 by the tension control member. For example, rotating the handle 35 in a first direction may translate / retract the tension control member in a proximal direction, thereby increasing the tension applied to the tension control line 200, and rotating the handle 35 in the opposite direction may translate / extend the tension control member in a distal direction, thereby reducing the tension applied to the tension control line 200. In other words, operation of the handle 35 in the first direction generally stops the expansion of the frame 55 of the implant 20 and / or folds the frame 55 of the implant 20 (e.g., to allow repositioning of the implant 20), and operation of the handle 35 in the second direction generally stops the folding of the frame 55 and / or expands the frame 55 by the action of the handle 35 or as a result of the biasing of the frame 55 into the expanded configuration.

[0190] Generally, the tension control line 200 is releasably held by the tension control member at separate positions along the length of the tension control line 200. However, the tension control line 200 extends across the frame 55 and is coupled to the frame 55 at multiple locations. As a result, even if adjustments in tension are applied at the connection point between the tension control member and the tension control line 200, the tension is relatively evenly distributed across the tension control line 200 and the frame 55, thereby providing even expansion and folding of the frame 55 and improved control during deployment and placement of the implant 20.

[0191] In the embodiment of FIG. 12, the tension control line 200 is coupled (e.g., tied or adhered) to the inner arcuate member 115 of the frame 55. More generally, the tension control line 200 can be coupled to any suitable portion of the frame 55 such that the tension control line 200 extends substantially around the frame 55. For example, without limitation, in other embodiments of the present disclosure, the tension control line 200 may instead be secured to a spoke 95, the outer arcuate member 110, or any other suitable portion of the petal portion 100 of the frame 55.

[0192] In certain embodiments, the tension control line 200 may further be coupled to other locations on the frame 55 by additional control segments or linkage structures. For example, FIG. 12 shows the tension control line 200 coupled to the inner arcuate member 115 of the frame 55. The tension control line 200 is further coupled to each of the outer arcuate members 110 by corresponding links such as link 202. Similar to the control line 200, the link 202 can be formed of a wire, suture, or similar material and, in some cases, may be formed of the same material as the control line 200. During operation, the link 202 serves to further distribute tension to the outer arcuate members 110, thereby further improving control of the expansion and folding of the frame during deployment of the implant 20.

[0193] Although FIG. 12 shows the link coupling the tension control line 200 to the outer arcuate member 110, in other embodiments, depending on how the tension control line 200 is configured, the link may be used to couple the tension control line 200 to other elements of the frame 55. For example, in an embodiment where the tension control line 200 is coupled to the outer arcuate member 110, the link may be used to couple the tension control line 200 to the inner arcuate member 115.

[0194] V. Deployment of an Implant Having a Tension Control Line As described above, the implant according to the present disclosure may include a tension control line for enhanced control during deployment and implantation. Such delivery and implantation may be further facilitated by a corresponding delivery tool configured to adjust and control the tension applied to the tension control line and selectively release the implant when properly positioned.

[0195] FIG. 13 is a photograph including the delivery tool 300 according to the present disclosure in a disassembled state. As shown, the delivery tool 300 generally includes a sheath 302, a release catheter 304, and a tension control assembly 306. Also shown is an implant 20 including a tension control line 200. The sheath 302 generally forms the outer surface of the delivery tool 300 and houses the other components during insertion into the patient. More specifically, the release catheter 304 is generally disposed within the sheath 302, and the tension control assembly 306 is disposed within the release catheter 304.

[0196] As will be described in more detail below, the tension control line 200 of the implant 20 is releasably coupled to the tension control assembly 306 by the release catheter 304 and is maintained in a folded state within the sheath 302 during initial insertion into the patient. During deployment, the release catheter 304 is extended distally from the sheath 302, thereby enabling the implant 20 to expand. Subsequent control of the expansion and folding of the implant 20 is facilitated by a tension control member 320 extending from the tension control assembly 306 that is coupled to the tension control line 200 of the implant 20 by the release line 350 of the release catheter 304. After the implant 20 is placed within the patient's body, the release line 350 is retracted to disconnect the tension control member 320 from the tension control line 200, thereby releasing the implant 20.

[0197] FIG. 14 is a cross-sectional view of the distal portion 301 of the delivery tool 300 in an assembled state, with the release catheter 304 and the tension control assembly 306 each in an extended configuration, for explaining various elements of the delivery tool 300. FIG. 15 is also a cross-sectional view of the distal portion 301 of the delivery tool 300 further including the implant 20, showing the delivery tool 300 in a retracted state as would apply during initial insertion of the delivery tool 300 into a patient. For the purpose of showing the attachment of the implant to the release catheter 304, only the frame 55 of the implant 20 and related components are shown partially in FIG. 15.

[0198] As described above, the tension control assembly 306 generally includes a tension control member 320 releasably coupled to the control line 200 of the implant 20. As shown in FIGS. 14 and 15, the tension control member 320 can be in the form of a cable, control suture, wire, or similar elongate structure extending distally from the distal end of the tension control shaft 324. In at least certain embodiments, the tension control member 320 can terminate in a loop (such as loop 322) or similar structure to facilitate attachment of the tension control member 320 to the tension control line 200 of the implant 20. FIG. 19 is a photograph of the tension control assembly 306 disposed within the release catheter 304, with the tension control member 320 extending distally from the catheter body 352 of the release catheter 304.

[0199] The release catheter 304 includes a release line 350 disposed within and extending through the catheter body 352. The catheter body 352 further defines two sets of lateral holes to facilitate the pulling and releasing functions of the delivery tool 300. More specifically, the catheter body 352 defines one set of proximal holes 360 and one set of distal holes 362. The catheter body 352 further defines a distal opening 357. As shown in FIGS. 14 and 19, the tension control assembly 306 is generally assembled with the release catheter 304 in such a manner that the tension control member 320 extends distally through the proximal holes 360.

[0200] The implant 20 is generally coupled to the delivery tool 300 by using a release line 350 to couple the implant 20 to a tension control member 320. FIG. 16 is a photograph of a proximal perspective view of the implant 20 in an expanded state, coupled to the delivery tool 300, to show such a coupling. As shown in detail B of FIG. 16, a loop 201 of the tension control line 200 is pulled through a loop 322 of the tension control member 320. Next, the release line 350 passes through the loop 201 of the tension control line 200 and across the loop 322 of the tension control member 320, thereby securing the loop 201 of the tension control line 200 through the loop 322 of the tension control member 320. To release the coupling between the control line 200 and the tension control member 320, the release line 350 is slid out of the loop 201, thereby allowing the loop 201 to pass through the loop 322 of the tension control member 320 and disconnecting the tension control member 320 from the control line 200. Detailed photographs of the loop 201 of the tension control line 200 coupled to the loop 322 of the tension control member 320 are provided in FIGS. 17 and 18.

[0201] Referring again to FIG. 15, routing of the release line 350 generally includes routing the release line 350 (shown in dashed lines for clarity of distinction from other illustrated elements) through the distal hole 362 of the catheter body 352 and out of the catheter body 352. Next, as described above and as shown in FIGS. 16-18, the release line 350 can be routed proximally to connect the control line 200 to the tension control member 320. Then, when the release line 350 is routed proximally and back into the catheter body 352 through the proximal hole 360, there, the release line 350 can be secured, for example by friction, until the implant 20 is released.

[0202] As shown in FIG. 15, in at least certain embodiments, the closure plug 50 of the implant 20 may include an annular protrusion 51 extending proximally that defines an annular opening 53 opening in the proximal direction and a laterally extending hole 57 communicating with the annular opening 53, respectively. In such an embodiment, the annular protrusion 51 may be disposed within the distal opening 357 (shown in FIG. 14) of the release catheter 304 during insertion and delivery into the implantation position, and further, the release line 350 may be routed through the hole 57 into the annular opening 53 before being passed through the distal hole 362 of the catheter body 352.

[0203] FIGS. 20-22 illustrate a general process of releasing the implant 20 from the delivery tool 300. First referring to FIG. 20, the delivery tool 300 and the implant 20 are shown in a state where the frame 55 of the implant 20 is in an expanded form and is also coupled to the delivery tool 300. More specifically, the implant 20 is coupled to the delivery tool 300 by the release lines 350 of the release catheter 304, and each release line passes through the catheter body 352, through the annular protrusion 51 of the implant 20, through one of the distal holes 362 of the catheter body 352, through one of the loops 201 of the tension control line 200 extending through one of the loops 321 of the tension control member 320, and is routed back into the catheter body 352 through one of the proximal holes 360. As described above, in at least certain embodiments, the end 356 of the release line 350 may be retained within the catheter body 352 by friction.

[0204] In the state shown in FIG. 20, when the tension control shaft 324 of the tension control assembly 306 is actuated (e.g., by translating and / or rotating the shaft or a handle assembly coupled to the shaft), the tension applied to the frame 55 of the implant 20 can be changed. At that time, the frame 55 can be expanded and / or folded to facilitate the placement of the implant 20 before releasing the implant 20 from the delivery tool 300.

[0205] Next, referring to FIG. 21, the delivery tool 300 and the implant 20 are shown during the process of releasing the implant 20 from the delivery tool 300. Generally, the release of the implant 20 from the delivery tool 300 is performed by pulling the release line 350 proximally through the catheter body 352. As shown, for each release line 350, such pulling, as indicated by the white arrows, passes the end 356 of the release line 350 out of the catheter body 352 through one of the proximal holes 360, through one of the loops 201 of the tension control line 200, releases the loop 201 from the corresponding control member 320, passes through one of the distal holes 362 of the catheter body 352 and the annular protrusion 51 of the implant 20, and re-enters the catheter body 352 through the distal opening 357 of the catheter body 352. As a result, as shown in FIG. 22, when the release line 350 is pulled, the implant is detached from the delivery tool, and the delivery tool 300 can be removed while leaving the implant 20 in place. After the release of the implant 20, each of the release catheter 304 and the tension control assembly 306 can be retracted proximally from the sheath 302 and / or removed proximally.

[0206] In particular, the process of releasing the implant 20 from the delivery tool 300 by pulling on the release line 350 applies a net force to the implant 20, and that force causes the frame 55 to expand and / or resists the folding of the frame 55. More specifically, when the release line 350 is pulled to release the implant 20, the release line 350 applies a net distal force to the implant 20, thereby pushing the implant 20 into its current implantation position. Moreover, since such a distal force is applied to the connection between the control line 200 and the tension control member 320, this force acts to further expand or otherwise provide an additional reaction force against the folding of the frame 55. In contrast, if a net proximal force is applied, the implant 20 may come out of position or the frame 55 may undergo partial folding, either of which may risk the implant 20 shifting or losing its alignment. Thus, by retrieving the release line 350 as described above, the correct placement of the implant 20 is more easily controlled and is more likely to be maintained even after the implant 20 is released.

[0207] VI. Multi-Part Closure Plug Figures 23 and 24 show the distal portion of an exemplary implant 400 that may be used in embodiments of the present disclosure. More specifically, FIG. 23 is a side view of the distal portion of the implant 400, and FIG. 24 is a cross-sectional view of the implant 400, each highlighting the closure plug 401 of the implant 400.

[0208] As shown, the closure plug 401 includes a closure plug body 402 that defines a cavity 403 in which the insert 404 is disposed. The insert 404 is coupled to the closure plug body 402. In the specific embodiment shown in FIGS. 23 and 24, the insert 404 is coupled to the closure plug body 402 by a screw connection 406; however, any suitable connection (e.g., adhesive, welding, etc.) may be used instead of the screw connection.

[0209] The closure plug 401 further includes a frame base 408 disposed distally of the insert 404 within the cavity 403 of the closure plug body 402. The frame base 408 is coupled to a frame 455 of the implant 400 (partially shown and may be substantially similar to other frames disclosed herein), and the frame 455 of the implant 400 extends from the frame base 408 and exits proximally from the closure plug body 402. The frame base 408 may be coupled to the closure plug body 402 or may be held in place by the insert 404.

[0210] The insert 404 further includes an annular protrusion 410 extending proximally. The annular protrusion 410 includes a side wall 412 through which one or more laterally extending holes 414 may be defined. As described above with respect to FIGS. 15 and 20-22, during use of the system disclosed herein, the release line of the delivery tool may be routed through this hole 414 to secure the implant 400 to the delivery tool, more specifically, the release catheter of the delivery tool.

[0211] The closure plug 401 further includes a marker 416 disposed within the closure plug body 402. In certain embodiments, the marker 416 can be a radiopaque marker to facilitate fluoroscopic viewing of the implant 400 during delivery and implantation. As shown, the marker 416 can be embedded within the closure plug body 402, such as by molding the closure plug body 402 around the marker 416. In other embodiments, the cavity 403 may be shaped to receive the marker 416 in addition to the insert 404 and the frame base 408. In still other embodiments, the marker 416 may be disposed on the outer surface of the closure plug body 402. Although shown as spherical beads in FIG. 24, the marker 416 can have any suitable shape. Similarly, any suitable number of markers can be incorporated into the closure plug body 402. In other embodiments, the closure plug body 402 may be formed from a material that includes a radiopaque additive. In still other embodiments, either or both of the frame base 408 and the insert 404 may be formed from a radiopaque material or may include one or more radiopaque markers.

[0212] VII. Skirted Sheet Base Closure Assembly As described above, embodiments of the implant according to the present disclosure can include a closure body supported by a frame, with a thin sheet supported by and extending around a proximal portion of the frame. When the implant is deployed within the heart to assist in the function of a heart valve, the frame is supported by the valve annulus or atrial wall such that the closure body is positioned to interact with and seal against the valve leaflets. In certain embodiments, the thin sheet can be formed from a material that allows for ingrowth into tissue so that the implant becomes more firmly anchored within the heart over time. In addition to this structural function, the thin sheet may be configured to at least partially overlap one or more commissures of the valve leaflets to correct or reduce commissural regurgitation.

[0213] In addition to the thin outer sheet described above, embodiments of the present disclosure may alternatively or additionally include an inner sheet. For example, an implant of the present disclosure may include a closure assembly that includes a closure body (e.g., a Brunnow-type closure plug or other closure plug described above) and a sheet of material that extends circumferentially from and around the closure body (generally referred to herein as a "skirt portion" or "inner sheet"). In such embodiments, the inner sheet may be coupled to the closure body and / or a portion of the implant frame extending from the closure body. In other embodiments, the closure assembly may not have a closure body, and the inner sheet may form a cap-like structure at the distal end of the implant that is supported by and coupled to the distal portion of the frame. In such implants, the inner sheet may provide a sealing surface for the valve tip that is similar to that provided by the closure body. Similar to the outer sheet, the inner sheet may be formed of a material that promotes or enables ingrowth within the tissue to create a smooth layer of living cells. The layer of living cells may provide a barrier between the inner sheet and the native valve tip to prevent a wear effect between the inner sheet and the native valve tip. Alternatively, the inner sheet may be formed of a low-friction material (e.g., PTFE or ePTFE) that resists ingrowth within the cells to provide a smooth surface that prevents a wear effect between the inner sheet and the native valve tip.

[0214] In certain embodiments, either the outer sheet and / or the inner sheet may have a multilayer structure in which internal pockets are defined between layers of sheet material. The pockets may include an additional layer of fabric (e.g., a layer of PET, ePTFE, or other fabric) that acts as a pad. The pockets may further or alternatively include a water-absorbing material that expands after implantation, such as a hydrogel (e.g., sodium polyacrylate or polyvinyl alcohol). In any of the foregoing cases, the filling may form a pad. In embodiments where the inner sheet is formed to include absorbent / expansive pockets, such pockets generally include a pad and / or otherwise increase the distance between the closure surface / sheet and the frame beneath the implant, thereby preventing and cushioning contact between the valve tip and the frame.

[0215] The foregoing aspects of the disclosure and related concepts are explained in further detail below with reference to the drawings.

[0216] Figures 25 and 26 show an example of an implant 2500 that includes a skirted closure assembly. Specifically, Figure 25 is a distal perspective view of the implant 2500, and Figure 26 is a proximal perspective view of the implant 2500. Figures 25 and 26 show the implant 2500 in an expanded state such as would exist when the implant 2500 is implanted in a heart valve to be repaired. As shown in Figure 25, the implant 2500 includes a distal end 2540 and a proximal end 2545. The distal end 2540 serves as the tip of the implant 2500 during implantation.

[0217] The implant 2500 includes a closure assembly 2502 that includes a central closure body 2550 and an inner sheet 2552 extending about the central closure body 2550. The implant 2500 further includes a frame 2555 and an outer sheet 2560 supported on the frame 2555. In the embodiments of FIGS. 25 and 26, the frame 2555 extends proximally from the central closure body 2550. When in the expanded state, the frame 2555 radially expands laterally outward with respect to the central longitudinal axis (longitudinal axis) 2570 of the implant 2500. In the expanded state, the inner sheet 2552 forms a first annular surface 2561 and the outer sheet 2560 forms a second annular surface 2564, each being supported on the frame 2555.

[0218] The first annular surface 2561 has a proximal radially outer edge 2563. Similarly, the second annular surface 2564 has a distal radially inner edge 2565 and a proximal radially outer edge 2566. The proximal radially outer edge 2563 of the first annular surface 2561 and the distal radially inner edge 2565 of the second annular surface 2564 define a central opening 2567 between the inner sheet 2552 and the outer sheet 2560. The proximal radially outer edge 2566 of the outer sheet 2560 may form the most proximal radially outer boundary of the implant when in the expanded state; however, at least a portion of the frame 2555 may extend beyond the proximal radially outer edge 2566 of the outer sheet 2560, as shown in FIGS. 25 and 26. The central longitudinal axis 2570 passes through the most distal end 2575 of the central closure body 2550. In view of the foregoing, in at least certain aspects, the frame 2555 is generally designed to seat on the floor of the atrium, induce annulus reduction, and form a neoannulus.

[0219] In addition to being annular, the first annular surface 2561 and the second annular surface 2564 may each be conical or relatively conical (e.g., parabolic).

[0220] When the implant 2500 is in the folded state, for example, while delivering the implant 2500 to the target site via a corresponding tool (e.g., tool 15 in FIG. 1A), the frame 2555, the inner sheet 2552, and the outer sheet 2560 are folded symmetrically about the central longitudinal axis 2570. Thus, similar to the implant 20 in FIGS. 2 - 6, the implant 2500 can transition from the folded state to the expanded state like an umbrella. For example, as described hereinabove with respect to the implant 20, the implant 2500 can be maintained in the folded state by the tool 15 in preparation for implanting the implant into the target heart valve to allow the implant 2500 to pass through the patient's vasculature and enter the atrium (similar to the state shown in FIG. 7 with respect to the implant 20). For example, when the implant 2500 is maintained in the folded state by being confined within the tubular sheath 76 of the delivery tool 15, the implant 2500 can be delivered to and deployed at the target site via an antegrade percutaneous route (e.g., the transfemoral artery route or the transjugular vein route) when the patient is in conscious sedation during the procedure. Once correctly positioned in the target heart valve for repair, the physician can activate the tool 15 such that the tool 15 no longer maintains the implant 2500 in the folded state. Since the frame 2555 of the implant 2500 is biased to self-expand, the implant 2500 self-expands into the expanded state to fix itself within the target heart valve and reduce backflow.

[0221] The central occluder 2550 can take various forms and shapes. For example, as described above with respect to the implant 20, the central occluder 2550 can have a bullet or conical shape. Further details regarding such shapes have been provided previously. Another alternative shape of the central occluder 2550 is a sphere, as shown in FIGS. 25 and 26. In such an embodiment, the central occluder 2550 can include a distal sphere 2580 (shown in FIG. 25) having a cylindrical side surface 2585 (shown in FIG. 26) extending proximally therefrom. In a particular embodiment, the distal sphere 2580 can be spherical; alternatively, it may have an oval or rectangular shape. More generally, the distal sphere 2580 can have a shape selected to be non-traumatic during delivery and implantation purposes, facilitating sealing of the distal sphere 2580 against the cardiac valve leaflet and reducing or eliminating central backflow through the cardiac valve leaflet.

[0222] Generally, the characteristics of the central occluder 2550 can be similar to those of the central occluding plug 50 of the implant 20. For example, the central occluder 2550 can be formed of, filled with, or fillable (e.g., with saline) various materials including angiographic and / or echolucent materials, and can have properties and dimensional characteristics such as those of the central occluding plug 50 described above.

[0223] Just as the thin sheet 60 of the implant 20 is supported by the frame 55, each of the inner sheet 2552 and the outer sheet 2560 is supported on and fixed to the frame 2555. For example, without limitation, the inner sheet 2552 and / or the outer sheet 2560 can be fixed to the frame 2555 by suturing each sheet to the inner surface and / or the outer surface of the frame 2555. In other embodiments, the inner sheet 2552 or the outer sheet 2560 can include a cuff or similar folded-back structure that is folded back at the end of the frame 2555. For example, as shown in FIG. 26, the inner sheet 2552 is folded back and sutured to the distal portion 2558 of the frame. More specifically, the distal portion 2558 of the frame includes a circumferential arrangement of arcuate petal-shaped portions (such as the arcuate petal-shaped portion 2557) that extend distally from the central closure body 2550. The inner sheet 2552 is then wrapped around the distal surface of the distal portion 2558 of the frame, folded back over each arcuate petal-shaped portion 2557, and sutured in place so that the inner sheet 2552 is fixed to the distal portion 2558 of the frame.

[0224] Alternatively, each of the inner sheet 2552 and the outer sheet 2560 can be fixed to the frame 2555 by suturing, welding, adhesion / sticking, stapling or any other suitable fixing method or combination of fixing methods. The inner sheet 2552 and / or the outer sheet 2560 can be on the distal side, proximal side, or both sides of the frame 2555 such that the frame extends through and along the inner sheet 2552 and / or the outer sheet 2560. In at least one specific embodiment, each of the inner sheet 2552 and the outer sheet 2560 is supported on the distal side of the frame 2555 such that when implanted, the outer sheet 2560 contacts the tissue of the atrial floor and the inner sheet 2552 is positioned to interact with and seal the valve leaflets.

[0225] Depending on the specific embodiment, the inner sheet 2552 and / or the outer sheet 2560 can be formed of, or include, a woven or knitted fabric or cloth that promotes in-growth of tissue. The cloth for the inner sheet 2552 and / or the outer sheet 2560 can generally have any of the properties or characteristics described above with respect to the thin sheet 60 of the implant 20. With respect to the outer sheet 2560, the porosity of the cloth can assist in reducing cross-linked tricuspid regurgitation. Further reduction of cross-linked tricuspid regurgitation can be provided by angulation of the frame 2555 that provides intimate contact between the outer sheet 2560 and the commissure in the circumferential direction. For example, when the implant 2500 is implanted in the target heart valve, in-growth of tissue into the cloth of the outer sheet 2560 helps reinforce the myocardium and prevent further expansion of the tissue, reducing the risk of future regurgitation. With respect to the inner sheet 2552, the porosity of the cloth can assist in reducing central regurgitation by providing an expanded surface only for the central occluder 2550 against which the valve leaflets can seal. In at least certain embodiments, the inner sheet 2552 can be formed of PTFE, ePTFE or a similar low-friction material to provide a smooth surface for the opposing native valve leaflets.

[0226] The frame 2555 can include spokes 2595 from which various arcuate leaflet-like portions extend. For example, as described above, the distal portion of the frame 2555 can include a distal or inner arcuate leaflet-like portion, such as the arcuate leaflet-like portion 2557, that supports the inner sheet 2552. The frame 2555 can further include an outer arcuate leaflet-like portion, such as the arcuate leaflet-like portion 2559, configured to support the outer sheet 2560. The outer arcuate leaflet-like portion can be similar to the leaflet-like portion 100 of the implant 20 or can otherwise share its features and variations described in more detail above.

[0227] Frame 2555 can be made from a variety of superelastic materials and / or shape memory materials, such as nickel-titanium alloys (e.g., nitinol), which may also be laser cut from tubing or in the form of drawn wire. The form defined within the shape memory material can be defined therein by various cutting methods known in the art, including but not limited to lasers, water jets, electrical discharge machining (EDM), stamping, etching, milling, etc.

[0228] Similar to the central closure plug 50 and frame spokes or struts 95 of implant 20, after implantation, the closure assembly 2502 and spokes 2595 can be removed, leaving in place the second annular surface 2564 formed by the outer sheet 2560. In such an embodiment, a circumferential suture connection may exist between the spokes 2595 and the remaining portion of the frame 2555 radially outside the spokes 2595. Thus, by cutting this circumferential suture connection and passing the closure assembly 2502 and spokes 2595 through a catheter and removing them, the annular portion of the implant remains, which then serves as a "valve ring forming" frame.

[0229] Similar to the spokes 95 of implant 20, the spokes 2595 can extend proximally from the central closure body 2550 to the outer arcuate petal-shaped portion. In certain embodiments, the spokes 2595 can extend substantially parallel to and along the central longitudinal axis 2570 of the implant 2500 and extend near thereto. When the implant 2500 is in the expanded state, the spokes 2595 extend proximally from the central closure body 2550 and spread radially laterally from the central longitudinal axis 2570 to the outer arcuate petal-shaped portion. Generally, the spokes 2595 can be configured and have the same characteristics as the spokes of other frame aspects described herein. For example, the dimensional characteristics and variations previously provided for the frame 55 (and its elements) of implant 20 may similarly be applicable to the frame 2555 and its components.

[0230] The outer arcuate portion, such as the arcuate petal-like portion 2559, may be similar to the petal-like portion 100 of the implant 20. The inner arcuate petal-like portion, such as the arcuate petal-like portion 2557, may be located between a pair of spokes 2595. When in the expanded state, the inner arcuate petal-like portion may be straight or curved in a direction that radially expands laterally. In certain embodiments, when curved, the radius of curvature of the inner arcuate petal-like portion may be the same as or different from the radius of curvature of the spokes 2595. Although shown as including only a single arcuate member, each inner arcuate petal-like portion 2557 may alternatively include a plurality of arcuate members, such as the inner and outer arcuate members of the petal-like portion 100.

[0231] In various embodiments, the frame 2555 may include various numbers of inner arcuate petal-like portions. For example, in certain exemplary aspects, the frame 2555 may include 6 - 8, 4 - 10, or 2 - 12 inner arcuate petal-like portions. In the specific embodiments shown in FIGS. 25 and 26, for example, the frame 2555 includes 6 inner arcuate petal-like portions.

[0232] Similar to the frame 55, the frame 2555 may engage atrial tissue via protruding anchor members 2597 that may be in the form of small barbs. The anchor members 2597 are designed to securely engage atrial tissue without penetrating the tissue or coronary vessels. Depending on the aspect, the protruding anchor members or barbs 2597 may be curved to slide prior to engaging the tissue, and there may be one or multiple rows of protruding anchor members 2597. As shown in FIG. 25, for example, the frame 2555 includes three offset rows of protruding anchor members 2597, with the distal and intermediate rows extending through the outer sheet 2560 and the proximal row protruding from the distal end of the frame 2555. The additional details and alternative configurations provided previously for the protruding anchor member 105 are similarly applicable to the anchor members 2597, including embodiments where the direction is reversed such that 2597 protrudes distally and radially inward.

[0233] Figures 27 and 28 show another implant 2700 according to the present disclosure. Specifically, FIG. 27 is a perspective view of the distal side of the implant 2700, and FIG. 28 is a perspective view of the proximal side of the implant 2700. FIGS. 27 and 28 show the implant 2700 when it is in an expanded state, such as when implanted in a heart valve to be repaired. As shown in FIGS. 27 and 28, the implant 2700 includes a distal end 2740 (shown in FIG. 27) and a proximal end 2745. The distal end 2740 acts as the tip of the implant 2700 during implantation.

[0234] The implant 2700 includes a closure assembly 2702 disposed at the distal end 2740. In contrast to the closure assembly 2502 of the implant 2500, the closure assembly 2702 does not include a closure body. Rather, the closure in the closure assembly 2702 is provided solely by an inner sheet 2752 that forms a cap-like structure disposed on the distal end 2740. Similar to the implant 2500, the implant 2700 further includes a frame 2755 and an outer sheet 2760, and each of the inner sheet 2752 and the outer sheet 2760 is supported on the frame 2755. When in the expanded state, the frame 2755 radially expands laterally outwardly with respect to the central longitudinal axis 2770 (shown in FIG. 27) of the implant 2500. In the expanded state, the inner sheet 2752 forms a distal surface 2761, and the outer sheet 2760 forms an annular surface 2764, each of which is supported on the frame 2755.

[0235] The distal surface 2761 has a proximal radially outer edge 2763, and the annular surface 2764 has a distal radially inner edge 2765 and a proximal radially outer edge 2766. The proximal radially outer edge 2763 of the distal surface 2761 and the distal radially inner edge 2765 of the annular surface 2764 define a central opening 2767 between the inner sheet 2752 and the outer sheet 2760. A central longitudinal axis 2770 passes through the most distal end 2775 of the inner sheet 2752. Considering the parabolic shape of the frame 2755, the implant 2700 can be configured to at least partially cross the atrial wall upward. However, in other embodiments, the frame 2755 may be configured such that the implant 2700 is generally designed to seat on the floor of the atrium. In any case, the implant 2700 can generally induce valvular constriction and form a neoannulus.

[0236] Similar to the implant 2500, the implant 2700 can transition into a collapsed state, such as during delivery of the implant 2700 to the target site. When collapsed, the frame 2755, the inner sheet 2752, and the outer sheet 2760 can be symmetrically collapsed about the central longitudinal axis 2570. Thus, similar to the implants 20 and 2500 of FIGS. 2-6, the implant 2700 can transition from a collapsed state to an expanded state like an umbrella. Also, similar to the frame 55 of the implant 20 and the central closure body 2550 of the implant 2500, the frame 2755 of the implant 2700 can be biased to self-expand so that the implant 2700 self-expands into the target heart valve and fixes itself therein.

[0237] The inner sheet 2752 and the outer sheet 2760 are each supported on the frame 2755 and fixed thereto using any suitable means. For example, and without limitation, the inner sheet 2752 and / or the outer sheet 2760 can be fixed to the frame 2755 by stitching, sewing, welding, adhesion / sticking, stapling or any other suitable fixing method or combination of fixing methods. In other embodiments, the inner sheet 2752 or the outer sheet 2760 can include a cuff or similar folded structure that is folded back onto a portion of the frame 2755. In the specific embodiment shown in FIG. 28, the inner sheet 2752 is joined to the distal frame portion 2758 of the frame 2755 by stitching or otherwise without such a cuff or fold.

[0238] Similar to the sheets described previously herein, the inner sheet 2752 and / or the outer sheet 2760 can be on the distal side, proximal side or both sides of the frame 2755 such that the frame extends through and along the inner sheet 2752 and / or the outer sheet 2760. In at least one specific embodiment, each of the inner sheet 2752 and the outer sheet 2760 is supported on the distal side of the frame 2755 such that when implanted, the outer sheet 2760 contacts the tissue of the atrial floor and / or atrial wall and the inner sheet 2752 is positioned to interact with and seal the valve leaflets. Similar to the aspects described herein, the inner sheet 2752 and / or the outer sheet 2760 can be formed of or include a woven or knitted fabric or cloth that promotes in-growth into tissue to provide the various advantages described above.

[0239] Embodiments of the present disclosure are not limited to any particular size or dimension and may be modified or customized to meet the needs of the patient and the specific application. Nevertheless, in certain embodiments, the proximal radially outer edge 2763 of the inner sheet 2752 may be from about 18 mm to about 28 mm. For example, in one specific embodiment, the proximal radially outer edge 2763 may be 23 mm. Similarly, the distal radially inner edge 2765 may be from about 35 mm to about 55 mm. For example, in one specific embodiment, the distal radially inner edge 2765 may be 44 mm. Finally, the proximal radially outer edge 2766 may be from about 45 mm to about 65 mm. In one example, the proximal radially outer edge 2766 may be 55 mm.

[0240] Implant 20 and implant 2500 each included respective frames that primarily relied on a spoke-based design, while frame 2755 shows an example of a petal-based frame structure. Referring to FIG. 28, frame 2755 includes a distal frame portion 2758 that supports inner sheet 2752 and a proximal frame portion 2759 that supports outer sheet 2760. Generally, each of distal frame portion 2758 and proximal frame portion 2759 includes a set of circumferentially distributed arcuate petal-shaped portions configured to fold and expand in a similar manner as implant 2700 is folded and expanded during delivery and implantation.

[0241] As shown in detail C of FIG. 28, the distal frame portion 2758 may include an arcuate petal-like portion having an oval, diamond, or other elongated shape (e.g., substantially diamond-shaped but having rounded vertices or curved sides). Each such arcuate petal-like portion may be defined by its respective major axis and minor axis. For example, as shown in detail C, the arcuate petal-like portion 2780A may have a major axis 2781A that extends substantially longitudinally and a minor axis 2782A that extends circumferentially. In certain embodiments, adjacent arcuate petal-like portions may join at or near a vertex along the minor axis, and these vertices are generally referred to as co-vertices. For example, as shown in FIG. 28, the arcuate petal-like portion 2780A and the arcuate petal-like portion 2780B are joined at a junction 2784 that is disposed more distally than the co-vertex of the arcuate petal-like portion 2780A and the arcuate petal-like portion 2780B.

[0242] Similarly, the proximal frame portion 2759 may include an arcuate petal-like portion having an oval, diamond, or other elongated shape. Each such arcuate petal-like portion may be defined by its respective major axis and minor axis. For example, the arcuate petal-like portion 2785A may have a major axis 2786A that extends substantially longitudinally and a minor axis 2787A that extends circumferentially. In certain embodiments, adjacent arcuate petal-like portions of the proximal frame portion 2759 may be joined at or near a vertex (i.e., the co-vertex of the arcuate petal-like portion). For example, the arcuate petal-like portion 2785A and the arcuate petal-like portion 2785B are joined at a junction 2789 that is disposed at the corresponding co-vertex of the arcuate petal-like portion 2785A and the arcuate petal-like portion 2785B.

[0243] As further shown in FIG. 28, the arcuate petal-like portions of the distal frame portion 2758 may be joined to respective arcuate petal-like portions of the proximal frame portion 2759. For example, the arcuate petal-like portion 2780A is joined to the arcuate petal-like portion 2785A by a longitudinal member 2790 that extends between the proximal vertex 2791 of the arcuate petal-like portion 2780A and the distal vertex 2792 of the arcuate petal-like portion 2785A.

[0244] Similar to the frame described herein, frame 2755 can be made from a variety of superelastic and / or shape memory materials, such as nickel-titanium alloys (e.g., Nitinol), which may be laser cut from tubing or in the form of drawn wire. The form defined within the shape memory material can be defined therein by various cutting methods known in the art, including but not limited to lasers, water jets, electrical discharge machining (EDM), stamping, etching, milling, etc.

[0245] Depending on the embodiment, frame 2755 can include a different number of inner and / or outer arcuate petal-like portions. For example, in certain exemplary embodiments, frame 2755 can include 10 - 14, 8 - 16, or 6 - 18 inner and outer arcuate petal-like portions. In the specific embodiments shown in FIGS. 27 and 28, for example, frame 2755 includes 12 inner and outer arcuate petal-like portions each, with each inner arcuate petal-like portion joined to a corresponding outer arcuate petal-like portion. In other embodiments, the number of inner arcuate petal-like portions may differ from the number of outer petal-like portions. For example, frame 2755 may include twice the number of inner arcuate petal-like portions as outer petal-like portions. Moreover, regardless of whether the number of inner arcuate petal-like portions matches the number of outer arcuate petal-like portions, not all of the inner arcuate petal-like portions need be joined to corresponding outer arcuate petal-like portions, and not all of the outer arcuate petal-like portions need be joined to corresponding inner arcuate petal-like portions. Thus, for example, in one embodiment, the implant may include twice the number of inner arcuate petal-like portions as outer arcuate petal-like portions, and every other inner arcuate petal-like portion may be joined to an outer arcuate petal-like portion. In another embodiment, the number of inner and outer arcuate petal-like portions is the same; still, the joining may be between every other inner and outer arcuate petal-like portions.

[0246] As shown in FIGS. 27 and 28, each inner arcuate petal-like portion is uniform, similar to each outer arcuate petal-like portion. In other embodiments, the inner and outer arcuate petal-like portions may differ in any direction. For example, the inner arcuate petal-like portion alternately includes an arcuate petal-like portion having a first major axis dimension and an arcuate petal-like portion having a second major axis dimension different from the first major axis dimension.

[0247] Hereinafter, with reference to FIGS. 31 to 33, other examples of alternative frame structures will be described.

[0248] Although not shown in FIGS. 27 and 28, the frame 2755 may engage atrial tissue via a protruding anchor member, such as the protruding anchor member 105 of the implant 20 described above or the protruding anchor member 2597 of the implant 2500 described above.

[0249] VIII. Alternative Implant Frame Shapes The overall shape of the implant according to the present disclosure when in the expanded state may vary among embodiments to address the various needs of the patient. In particular, the shape of the implant may be various to accommodate changes in the patient's anatomical structure and medical condition. For example, if the patient may have a weakened valve or a valve showing a decrease in excursion, an implant structure in which the closure assembly is disposed deeper in the ventricle such that contact and sealing between the closure assembly and the valve tip occur at an earlier stage of the valve tip excursion may be advantageous. In contrast, if there is commissural regurgitation despite substantially normal valve tip function, a more planar or flat implant structure in which the implant sheet covers a larger proportion of the tricuspid valve structure may be more advantageous. These and other considerations will be described in more detail below.

[0250] In one aspect, when in the expanded state, the implant according to the present disclosure can have various curvatures. Examples of various curvatures are provided in FIGS. 29A - 29C. More specifically, FIG. 29A is an elevation view of an implant 2900A having a shape that is concave in the proximal direction when deployed / expanded, FIG. 29B is an elevation view of an implant 2900B having a shape that is concave in the distal direction when deployed / expanded, and FIG. 29C is an elevation view of an implant 2900C including a proximal portion that is concave in the proximal direction and a distal portion that is concave in the distal direction. For clarity and brevity of explanation, each of implants 2900A - 2900C is shown in a simplified view where the overall shape is emphasized and specific elements of each implant are omitted. Thus, unless otherwise described, implants 2900A - 2900C can generally include and be consistent with elements of any other embodiment described herein. For example, FIGS. 29A - 29C generally omit details regarding the frame of the corresponding implant; it should be understood that such a frame can conform to any frame style disclosed herein.

[0251] Referring first to FIG. 29A, implant 2900A includes a distal end 2902A and a proximal end 2904A, and a longitudinal axis 2906A of implant 2900A extends between distal end 2902A and proximal end 2904A. Implant 2900A includes a frame 2908A that supports a closure assembly 2910A at distal end 2902A. As shown, closure assembly 2910A includes an inner sheet 2912A; in other embodiments, closure assembly 2910A may include, instead of or in addition to inner sheet 2912A, a closure body. For example, closure assembly 2910A may include a spherical or bulbous closure plug about which inner sheet 2912A extends. Implant 2900A further includes an outer sheet 2914A supported on frame 2908A at proximal end 2904A, such that an annular opening 2916A is defined between inner sheet 2912A and outer sheet 2914A.

[0252] FIG. 29A shows the implant 2900 in an expanded state (e.g., after deployment). As shown, the implant 2900A has a shape that is concave in the proximal direction defined by a radius of curvature (RC-A) such that the implant 2900A has a generally bowl-shaped overall shape. The implants 2700 of FIGS. 27 and 28 are examples of proximally concave implants according to the present disclosure and are described in further detail above. In particular, the implant 2900A is shown as hemispherical, but alternatively may have an oval or similarly rounded but non-spherical shape.

[0253] RC-A can vary in embodiments of the present disclosure depending on the specific application and patient needs. For example, when the overall diameter of the proximal end 2904A is held constant, RC-A generally controls the position of the distal end 2902A and the closure assembly 2910A relative to the proximal end 2904A. More specifically, as RC-A increases, the implant 2900A assumes a shallower geometry when in the expanded shape, and after deployment, the distal end 2902A moves closer to the annulus. Conversely, as RC-A decreases, the implant 2900A assumes a deeper shape and the distal end 2902A and closure assembly 2910A deploy further within the ventricle. As noted above, the placement of the closure assembly 2910A relative to the annulus determines when and how the leaflets contact and seal the closure assembly 2910A, and as a result, RC-A can be selected to account for the various needs and specificities of a particular patient.

[0254] For example, the proximally concave / distally convex shape shown in FIG. 29A generally includes a larger and more accessible gap compared to the distally concave / proximally convex design shown in FIG. 29B and described in more detail below. As a result, the proximally recessed implant according to the present disclosure can enable other heart devices, such as a pacemaker lead, to be placed more easily and accurately through the implant. The proximally recessed implant according to the present disclosure can also be easily inverted. Such invertibility can facilitate removal of the implant at a later date because the implant can be narrowed into a funnel shape and pulled back into the retrieval catheter.

[0255] Regardless of the concavity, an implant according to the present disclosure having a frame formed of metal or other radiopaque material is visible on fluoroscopy and can further facilitate placement of a pacemaker lead by providing a target for delivery of the pacemaker lead. The frame of the implant can also provide restraint of the pacemaker lead and reduce movement of the lead after delivery and implantation. In particular, such reinforcement of the lead can prevent or reduce the likelihood that the pacemaker lead will interfere with or otherwise interfere with the movement of the valve leaflet.

[0256] Next, referring to FIG. 29B, the implant 2900B includes a distal end 2902B and a proximal end 2904B, and a longitudinal axis 2906B of the implant 2900B extends between the distal end 2902B and the proximal end 2904B. FIG. 29B shows the implant 2900B in a state of being expanded about the longitudinal axis 2906B. The implant 2900B includes a frame 2908B shown as including an inner sheet 2912B and a closure body 2913B that support a closure assembly 2910B at the distal end 2902B. In other embodiments, the closure assembly 2910B may alternatively include only one of the inner sheet 2912B and the closure body 2913B. The implant 2900B further includes an outer sheet 2914B supported on the frame 2908B at the proximal end 2904B, and an annular opening 2916B is defined between the inner sheet 2912B and the outer sheet 2914B. When in the expanded state (e.g., after deployment), the implant 2900B has a shape that is concave in the distal direction defined by a radius of curvature (RC-B) such that the implant 2900B has a generally funnel-shaped overall shape. Examples of implants having a similar shape include the implant 20 and the implant 2500 described in more detail previously.

[0257] Similar to the RC-A of the implant 2900A, the RC-B of the implant 2900B can vary in the embodiments of the present disclosure depending on the specific use and the needs of the patient. In particular, the distally recessed design of the implant 2900B ensures that the initial contact between the valve tip and the implant 2900B is with the closure assembly 2910B, as opposed to contact with a portion of the frame 2908B as can occur with the distally recessed design of the implant 2900A. More generally, the distally recessed shape reduces the overall size of the implant portion within the ventricle and reduces the likelihood that the implant will interfere with or otherwise disrupt the heart structure and its respective functions. For example, the distally recessed shape reduces the contact between the valve tip and the implant, thereby reducing the likelihood that the implant will interfere with or otherwise impede the stroke of the valve tip. As another example, a distally convex shape may reduce the likelihood that the implant will interfere with or impede the coronary sinus or similar blood vessels of the heart.

[0258] The implant 2900C includes a distal end 2902C and a proximal end 2904C, and a longitudinal axis 2906C of the implant 2900B extends between the distal end 2902C and the proximal end 2904C. FIG. 29C shows the implant 2900C in an expanded state about the longitudinal axis 2906C. The implant 2900C includes a frame 2908C shown as including an inner sheet 2912C that supports a closure assembly 2910C at the distal end 2902C. In other embodiments, the closure assembly 2910C may further or alternatively include a closure body. The implant 2900C also includes an outer sheet 2914C supported on the frame 2908C at the proximal end 2904C, and an annular opening 2916C is defined between the inner sheet 2912C and the outer sheet 2914C.

[0259] The implant 2900C includes both a proximally recessed portion and a distally recessed portion. More specifically, the 2900C includes a proximal portion 2920C having a proximally recessed shape. The implant 2900C transitions into a distal portion 2922C having a distally recessed shape. In the embodiment shown in FIG. 29C, the distal portion 2922C further transitions into a proximally recessed cap portion 2924C that includes a closure assembly 2910C, and more specifically, an inner sheet 2912C. In other embodiments, the distal portion 2922C may instead terminate in a closure body, such as a central closure plug 50 of implant 20 or a central closure body 2550 of implant 2500.

[0260] When in the expanded state (e.g., after deployment), the shape of the implant 2900C can be defined by at least two radii of curvature. More specifically, the shape of the implant 2900C can be defined by a radius of curvature (RC-C) corresponding to the proximal portion 2920C (i.e., the proximally recessed portion of the implant 2900C) and a radius of curvature (RC-D) corresponding to the distal portion 2922C (i.e., the distally recessed portion of the implant 2900C). As long as the embodiments of the present disclosure further include a proximally recessed cap portion 2924C, the implant 2900C can further be defined by a radius of curvature (RC-E) corresponding to the proximally recessed cap portion 2924C. In certain embodiments, RC-E and RC-C can be the same; however, RC-E and RC-C may also differ such that the proximally recessed cap portion 2924C can have a somewhat more pronounced curvature than the proximal portion 2920C.

[0261] Each of implant 2900A, implant 2900B, and implant 2900C has an overall curved shape, but the implants according to the present disclosure may have a non-curved shape when deployed. Examples of such non-curved implants are provided in FIGS. 30A and 30B. More specifically, FIG. 30A is an elevation view of implant 3000A having a conical shape when deployed, and FIG. 30B is an elevation view of implant 3000B having a flat or planar shape when deployed. Similar to FIGS. 29A and 29B, for clarity and brevity of explanation, each of implant 3000A and implant 3000B is shown in a simplified view in which the overall shape is emphasized and specific elements of each implant are omitted. Thus, unless otherwise described, implants 3000A and 3000B generally may include and be consistent with elements of any other embodiment described herein.

[0262] Referring first to FIG. 30A, implant 3000A includes a distal end 3002A and a proximal end 3004A, and a longitudinal axis 3006A of implant 3000A extends between distal end 3002A and proximal end 3004A. Implant 3000A includes a frame 3008A that supports a closure assembly 3010A at distal end 3002A. As shown, closure assembly 3010A includes an inner sheet 3012A and a closure body 3013A. In other embodiments, closure assembly 3010A may alternatively include only one of inner sheet 3012A and closure body 3013A. Implant 3000A further includes an outer sheet 3014A supported at the proximal portion of frame 3008A, and an annular opening 3016A is defined between inner sheet 3012A and outer sheet 3014A.

[0263] FIG. 30A shows implant 3000 in an expanded state (e.g., after deployment). As shown, in contrast to the curved funnel shape of implant 2900B, implant 3000A has a funnel shape with straight sides. In other words, when deployed, implant 3000A has a conical or frustoconical shape that expands in the distal direction.

[0264] Similar to implants 2900A and 2900B, implant 3000A can be modified to vary the extent to which the closure assembly 3010A enters the ventricle when implant 3000A is deployed within the heart. For example, the general shape of implant 3000B can be determined by an angle θ, which can be defined as the angle between the side surface of the frame 3008A and the longitudinal axis 3006A of implant 3000A when implant 3000A is in the expanded / deployed state. Assuming that other dimensions of implant 3000A (e.g., the maximum diameter of the proximal end 3004A) remain substantially constant, a change in θ will vary the overall length of implant 3000A when expanded and, as a result, the depth of the closure assembly 3010A within the ventricle. More specifically, a decrease in θ will increase the overall length of implant 3000A when implant 3000A is deployed and the depth of the closure assembly 3010A within the ventricle. Conversely, an increase in θ will decrease the overall length of implant 3000A when deployed (e.g., resulting in a more planar-shaped implant 3000A in the expanded state) and decrease the depth of the closure assembly 3010A within the ventricle.

[0265] Next, referring to FIG. 30B, when deployed, the implant 3000B expands into a flat or planar shape. The implant 3000B includes a radially inner portion 3002B and a radially outer portion 3004B with respect to the longitudinal axis 3006B. When in the folded state (e.g., during delivery, when the implant 3000B is folded about the longitudinal axis 3006B), the radially inner portion 3002B forms the distal end or tip of the implant 3000B, while the radially outer portion 3004B forms the proximal end of the implant 3000B. Similar to other implants disclosed herein, the implant 3000B includes a frame 3008B that supports a closure assembly 3010B at the radially inner portion 3002B. As shown, the closure assembly 3010B includes an inner sheet 3012B. In other embodiments, the closure assembly 3010B may further include, or alternatively, a closure body 3013B shown in dashed lines in FIG. 30B. The implant 3000B further includes an outer sheet 3014B supported at the proximal portion of the frame 3008B such that an annular opening 3016B is defined between the inner sheet 3012A and the outer sheet 3014B.

[0266] Planar implants such as the implant 3000B can be particularly advantageous when regurgitation occurs despite a substantially normal leaflet excursion. When deployed, the implant 3000B can be positioned along the floor of the atrium across the valve annulus with the closure assembly 3010B centered or substantially centered. In embodiments where the closure assembly 3010B includes a closure body 3013B, the closure body 3013B may project into the valve annulus or project into the ventricle across the valve annulus depending on its size and shape. When the valve is in the closed position and the implant 3000B is properly positioned, the leaflets contact and seal the closure assembly 3010B. In this position, a portion of the closure assembly 3010B, such as the inner sheet 3012B, can extend above the leaflets, particularly at the commissure between the leaflets. By doing so, the inner sheet 3012B provides an additional expanded sealing surface against the leaflets, covering at least a portion of any commissure gap that may exist, thereby reducing regurgitation. In addition to the inner sheet 3012B, further reduction of regurgitation may be provided by an outer sheet 3014B that also seals the leaflets and may cover the commissure gap (which may exist near the outer edge of the valve annulus).

[0267] IX. Alternative Frame Configurations As described above, an implant according to the present disclosure includes a frame configured to support a distal closure assembly. The frame may further support or otherwise be coupled to one or more thin sheets or similar structures. In certain embodiments, such sheets may include a proximal or outer sheet configured to contact the atrial floor and / or a distal or inner sheet included in the closure assembly (such as a "skirt" extending circumferentially around the closure body of the closure assembly).

[0268] In addition to providing structural integrity, the implant frame according to the present disclosure is configured to be expandable about the longitudinal axis of the implant. More specifically, the implant frame according to the present disclosure is configured to transition between a collapsed state and an expanded state. The collapsed state may correspond to, for example, the state of the implant during delivery using a delivery tool, such as tool 15 (shown in FIG. 1A), tool 1115 (shown in FIGS. 11A - 11B), or delivery tool 300 (shown in FIG. 13) (each described in detail above). In contrast, the expanded state may correspond to the state of the implant after delivery and deployment within the patient's heart. The implant frame according to the present disclosure can be biased to the expanded state such that the implant transitions to the expanded state if there is no resistance provided by the delivery tool. For example, referring to FIG. 16, a tension control member 320 of the delivery tool is coupled to a tension control line 200 of the implant, and by applying tension to the tension control member 320, the user may be able to resist the expansion of the implant. In certain embodiments, the user may apply sufficient tension to collapse the implant (e.g., transition the implant from the expanded state to the collapsed state).

[0269] The present disclosure has previously described various exemplary frame styles. For example, FIGS. 2 - 8 and 12 include a first frame style for a distally concave implant in which radially extending spokes support an arcuate petal-like portion that is circumferentially distributed around a central closure plug. FIGS. 25 and 26 show a frame style that is similar but further includes an inner arcuate petal-like portion configured to support an inner sheet. FIGS. 27 and 28 introduce the concept of a proximally concave frame formed by joining an inner / distal set of circumferentially distributed arcuate petals to an outer / proximal set of circumferentially distributed arcuate petals. FIGS. 29A - 30B develop these general frame styles by providing further examples of overall frame shapes and configurations.

[0270] To further illustrate the scope of the frames contemplated by the present disclosure, FIGS. 31-33 provide additional examples of frame styles that may be used in an implant according to the present disclosure. In particular, each of FIGS. 31-33 describes an alternative frame style applicable to an implant that is concave in the proximal direction (similar to implant 2700 of FIGS. 27 and 28), although the concepts and structures shown in FIGS. 31-33 may be applicable to implants having a concave distal direction, frustoconical, planar, or other overall shape. In particular, FIGS. 31-33 omit certain features of the illustrated implants for clarity. For example, each of FIGS. 31-33 omits the back side (the back side relative to the illustrated perspective view) of the illustrated implant to more clearly show the structure and configuration of the implant's frame.

[0271] FIG. 31 shows an implant 3100 having a first alternative frame configuration. Implant 3100 includes a distal end 3102 and a proximal end 3104, and a longitudinal axis 3106 of implant 3100 extends between distal end 3102 and proximal end 3104. Implant 3100 includes a frame 3108 that supports a closure assembly 3110 at distal end 3102. As shown, closure assembly 3110 includes an inner sheet 3112; in other embodiments, closure assembly 3110 may include a closure body instead of or in addition to inner sheet 3112. Implant 3100 further includes an outer sheet 3114 supported at the proximal portion of frame 3108, such that an annular opening 3116 is defined between inner sheet 3112 and outer sheet 3114.

[0272] Similar to the frame 2755 of the implant 2700, the frame 3108 of the implant 3100 includes a distal frame portion 3118 that includes a first set of circumferentially distributed arcuate petal-like portions, such as arcuate petal-like portion 3120A and arcuate petal-like portion 3120B, and a distal frame portion 3138 that includes a second set of circumferentially distributed arcuate petal-like portions, such as arcuate petal-like portion 3140A and arcuate petal-like portion 3140B. As described with respect to FIGS. 27 and 28 above, the arcuate petal-like portions according to the present disclosure can have an oval, rhomboid, or other elongated shape (e.g., generally rhomboid but having rounded vertices or curved sides). More generally, the arcuate petal-like portions according to the present disclosure can have any suitable shape that enables folding and expansion of the frame and other functions described herein (e.g., support of fabric sheets such as inner sheet 3112 and outer sheet 3114).

[0273] As shown in FIG. 31, adjacent arcuate petal-like portions of the distal frame portion 3118 can be joined at or near their respective common vertices. For example, arcuate petal-like portion 3120A and arcuate petal-like portion 3120B are joined at a junction 3126 disposed at the corresponding common vertex of arcuate petal-like portion 3120A and arcuate petal-like portion 3120B. Similarly, adjacent arcuate petal-like portions of the proximal frame portion 3138 can be joined at or near their respective common vertices. For example, arcuate petal-like portion 3140A and arcuate petal-like portion 3140B are joined at a junction 3146 disposed at the corresponding common vertex of arcuate petal-like portion 3140A and arcuate petal-like portion 3140B.

[0274] The arcuate petal-like portions of the distal frame portion 3118 can be joined to respective arcuate petal-like portions of the proximal frame portion 3138. For example, arcuate petal-like portion 3120A is coupled to arcuate petal-like portion 3140A by a longitudinal member 3148 that extends between the proximal vertex 3125 of arcuate petal-like portion 3120A and the distal vertex 3145 of arcuate petal-like portion 3140A.

[0275] As shown in FIG. 31, the longitudinal member 3148 extending between the arcuate petal-shaped portion 3120A and the arcuate petal-shaped portion 3140A is substantially longer than the longitudinal member 2790 extending between the arcuate petal-shaped portion 2780A and the arcuate petal-shaped portion 2785A of the implant 2700 (shown in FIG. 28).

[0276] FIG. 31 shows the longitudinal member (e.g., longitudinal member 3148) extending between the proximal apex of the first set of arcuate petal-shaped portions and the distal apex of the second set of arcuate petal-shaped portions. However, in other embodiments, the longitudinal member may extend between other positions of the frame 3108. For example, in certain embodiments, the longitudinal member may be offset from the arcuate petal-shaped portions so as to extend between the circumferential joints of the arcuate petal-shaped portions. Thus, referring to FIG. 31 for example, the longitudinal member may extend between the joint (e.g., joint 3126) of the first set of arcuate petal-shaped portions and the joint (e.g., joint 3146) of the second set of arcuate petal-shaped portions. In other embodiments, the first set of arcuate petal-shaped portions can be rotationally offset from the second set of arcuate petal-shaped portions such that the joints of one set are aligned with the apices of the other set. In such embodiments, the longitudinal member may extend between the joint of one set and the apex of the other set. Thus, for example, the longitudinal member may extend between the joint (e.g., joint 3126) of the first set of arcuate petal-shaped portions and the distal apex (e.g., distal apex 3145) of the second set of arcuate petal-shaped portions. Alternatively, the longitudinal member may extend between the proximal apex (e.g., proximal apex 3125) of the first set of arcuate petal-shaped portions and the joint (e.g., joint 3146) of the second set of arcuate petal-shaped portions.

[0277] In embodiments of the present disclosure, either the inner sheet or the outer sheet may define one or more internal pockets. For example, in certain embodiments, the sheet may include two or more layers that are sewn or otherwise joined together to form an internal pocket between adjacent layers. In one embodiment, the adjacent layers may include a first layer disposed proximal or on the inner surface of the implant frame and a second layer disposed distal or on the outer surface of the implant frame, and the frame may extend between those layers. In other embodiments, the layers forming the internal pocket may all be disposed on the proximal / inner surface of the frame or the distal / outer surface of the frame. The pocket formed in this manner may be filled with an additional layer of a water-absorbing material such as cloth, batting, or hydrogel. In such cases, the filling generally forms a pad that can increase the distance between the closure surface / sheet and the frame underlying the implant, thereby preventing and cushioning contact between the valve tip and the frame.

[0278] Figure 32 shows an implant 3200 having another alternative frame configuration. The implant 3200 includes a distal end 3202 and a proximal end 3204, and a longitudinal axis 3206 of the implant 3200 extends between the distal end 3202 and the proximal end 3204. The implant 3200 includes a frame 3208 that supports a closure assembly 3210 at the distal end 3202. As shown, the closure assembly 3210 includes an inner sheet 3212; in other embodiments, the closure assembly 3210 may include a closure body instead of or in addition to the inner sheet 3212. The implant 3200 further includes an outer sheet 3214 supported at the proximal portion of the frame 3208, and an annular opening 3216 is defined between the inner sheet 3212 and the outer sheet 3214.

[0279] The frame 3208 of the implant 3200 includes a distal frame portion 3218 that includes a first set of circumferentially distributed arcuate petal-like portions, such as arcuate petal-like portion 3220A and arcuate petal-like portion 3220B, and a proximal frame portion 3238 that includes a second set of circumferentially distributed arcuate petal-like portions, such as arcuate petal-like portion 3240A and arcuate petal-like portion 3240B.

[0280] The first or inner set of arcuate petal-like portions of the implant 3200 are shown to be substantially similar to those of the implant 3100. On the other hand, the second set of arcuate petal-like portions of the implant 3200 have a shape that opens in the distal direction, in contrast to the oval shape of the implant 3100. More specifically, each arcuate petal-like portion of the second set of arcuate petal-like portions is formed by a pair of longitudinal members and an arcuate frame portion. For example, the arcuate petal-like portion 3240A is formed by longitudinal member 3248A, longitudinal member 3248B, and an arcuate frame portion 3249 that extends between longitudinal member 3248A and longitudinal member 3248B. As shown, each longitudinal member extends from the respective junction of the first set of arcuate petal-like portions. For example, longitudinal member 3248A extends from the junction 3226 between arcuate petal-like portion 3220A and arcuate petal-like portion 3220B. As described above with respect to the implant 3100, the first and second sets of arcuate petal-like portions of the implant 3200 may be offset in the rotational direction from the arrangement shown in FIG. 32 such that the longitudinal members instead extend from the proximal apex (e.g., proximal apex 3125) of the first set of arcuate petal-like portions.

[0281] Figure 33 shows an implant 3300 having yet another alternative frame configuration. The implant 3300 includes a distal end 3302 and a proximal end 3304, and a longitudinal axis 3306 of the implant 3300 extends between the distal end 3302 and the proximal end 3304. The implant 3300 includes a frame 3308 that supports a closure assembly 3310 at the distal end 3302. As shown, the closure assembly 3310 includes an inner sheet 3312; in other embodiments, the closure assembly 3310 may include a closure body instead of or in addition to the inner sheet 3312. The implant 3300 further includes an outer sheet 3314 supported at a proximal portion of the frame 3308, and an annular opening 3316 is defined between the inner sheet 3312 and the outer sheet 3314.

[0282] The frame 3308 of the implant 3300 includes a distal frame portion 3318 that includes a set of circumferentially distributed arcuate petal-like portions, such as arcuate petal-like portion 3320A and arcuate petal-like portion 3320B. The frame 3308 further includes a proximal frame portion 3338 that includes a second set of circumferentially distributed arcuate petal-like portions, such as arcuate petal-like portion 3340A and arcuate petal-like portion 3340B.

[0283] As shown in FIG. 33, the first or inner set of arcuate petal-like portions of the implant 3300 are shown to be substantially similar to those of the implant 3100. However, in contrast to the implant 3100, each arcuate petal-like portion of the second set of arcuate petal-like portions of the implant 3300 is formed by arcuate frame members that extend between longitudinal members. For example, the arcuate petal-like portion 3340A is formed by arcuate frame members 3341A and 3341B that extend between longitudinal members 3348A and 3348B.

[0284] As shown in FIG. 33, the longitudinal members 3348A and 3348B extend from the respective joints of the first set of arcuate petal-shaped portions. For example, the longitudinal member 3348A extends from the joint formed between the arcuate petal-shaped portion 3320A and the arcuate petal-shaped portion 3320B. As described above with respect to the implant 3100, the first and second sets of arcuate petal-shaped portions of the implant 3300 may be offset in the rotational direction from the arrangement shown in FIG. 33 so that the longitudinal members instead extend from the proximal apex (e.g., proximal apex 3325) of the first set of arcuate petal-shaped portions.

[0285] In the illustrated embodiment, the arcuate frame member 3341A is proximal to the arcuate frame petal-shaped member 3341B, and the arcuate frame member 3341A and the arcuate frame member 3341B are each recessed in the distal direction. In other embodiments, one or both of the arcuate frame member 3341A and the arcuate frame member 3341B may be recessed in the proximal direction. Also, in other embodiments, the combination of the arcuate frame member 3341A and the arcuate frame member 3341B may be replaced by a single arcuate frame member or supplemented with any suitable number of additional arcuate frame members. Moreover, the number of arcuate frame members may vary between the arcuate petal-shaped portions. Thus, for example, a particular arcuate petal-shaped portion may not include an arcuate frame member, may include one, or may include two or more, while others may include none.

[0286] As previously described herein, the implant according to the present disclosure is capable of transitioning between an expanded state (e.g., at the time of implantation) and a collapsed state (e.g., during delivery). The transition from the collapsed state to the expanded state moves the proximal portion of the implant's frame radially outward from the central longitudinal axis of the implant. The transition to the expanded state may also include a longitudinal movement of the proximal portion of the frame. As a result, when the implant expands, it extends radially outward but decreases in length along the longitudinal axis.

[0287] The presence, size, and amount of the arcuate flap portion contribute to the overall length of the implant when in the folded state. When the arcuate flap portion is folded (e.g., when the implant is in the folded state), the arcuate flap portion undergoes circumferential compression and longitudinal elongation, respectively. As a result, even if the first and second implants have the same overall dimensions when in their respective expanded states, the first implant having a greater and / or larger arcuate flap portion than the second implant will typically have a longer folded length than the second implant.

[0288] The relationship between the folded length and the characteristics of the arcuate flap portion can be utilized to design implants for specific applications. For example, if the surgeon anticipates that delivery and implantation may be difficult, a first implant having a frame with more and / or longer longitudinal members may be preferentially selected over a second implant having a frame with a greater and / or larger arcuate flap portion because it has a shorter and more manipulable length when in the folded state (i.e., during delivery). In contrast, if additional devices (e.g., pacemaker leads) will later have to be implanted in the patient, the surgeon may select the second implant because the size, shape, and arrangement of the openings defined by the arcuate flap portion provide additional options and flexibility for the delivery and support of the additional devices.

[0289] As another example, a design with a higher proportion of longitudinal members tends to exert less radial force when transitioning from the folded state to the expanded state and may generally exhibit lower radial stiffness. Thus, in embodiments where there is a risk that the heart tissue may be damaged by greater radial forces or where the implant is required to conform to a more complex shape within the heart, an implant frame with a higher proportion of longitudinal members and a lower proportion of arcuate flap portions (or similar expansion structures) may be selected.

[0290] Figures 31 - 33 show alternative frame configurations according to the present disclosure and are limited to a design that is concave in the proximal direction. Nevertheless, the frame configuration can be readily adapted to other implant shapes, including implants having an overall shape that is concave in the distal direction, frustoconical, planar, or a combination of different concave shapes. Figures 34 - 35B show specific frame alternatives that are realized, for example, in an implant having a combination of a proximally concave / distally concave distal portion.

[0291] Figure 34 shows an implant 3400 having a frame configuration similar to the frame configuration of implant 3300 of Figure 33. Implant 3400 includes a distal end 3402 and a proximal end 3404, and a longitudinal axis 3406 of implant 3400 extends between distal end 3402 and proximal end 3404. Implant 3400 includes a frame 3408 that can support a closure assembly at distal end 3302. Figure 34 omits the closure assembly to more clearly show the various features and configurations of frame 3408. Similar to other embodiments described herein, when included, the closure assembly can include a closure body and / or an inner sheet. Implant 3400 can also include an outer sheet (not shown in Figure 34) supported on the proximal portion of frame 3408, such that an annular opening is defined between the inner sheet / closure assembly and the outer sheet.

[0292] The frame 3408 of the implant 3400 includes a distal frame portion 3418 that includes a set of circumferentially distributed arcuate petal-like portions, such as arcuate petal-like portion 3420A and arcuate petal-like portion 3420B. The frame 3408 further includes a proximal frame portion 3438 that includes a second set of circumferentially distributed arcuate petal-like portions, such as arcuate petal-like portion 3440A and arcuate petal-like portion 3440B. Each arcuate petal-like portion of the second set of arcuate petal-like portions of the implant 3400 is formed by arcuate frame members that extend between longitudinal members. For example, the arcuate petal-like portion 3440A is formed by arcuate frame members 3441A and 3441B that extend between longitudinal members 3448A and 3448B. The longitudinal members 3348A and 3348B extend from the respective proximal ends of the arcuate petal-like portions of the first set of arcuate petal-like portions. For example, the longitudinal member 3448A extends from the proximal end 3426 of the arcuate petal-like portion 3420A.

[0293] In contrast to the implant 3300 of FIG. 33, which has a shape that is concave in the proximal direction, the implant 3400 of FIG. 34 has a varying concave shape, similar to the implant 2900C of FIG. 29C. More specifically, the implant 3400 includes a proximal portion 3450 that is concave in the proximal direction, a distal portion 3452 that is concave in the distal direction, and a cap portion 3454 that is concave in the proximal direction.

[0294] The implant 3400 further includes anchor members distributed circumferentially, such as anchor member 3456 and anchor member 3458. Anchor member 3456 is part of a first set of anchor members that extend radially outward from the proximal end of each arcuate frame member. Specifically, each anchor member of the first set of anchor members extends from the proximal end of the distal frame member of each arcuate petal-shaped portion. Thus, for example, anchor member 3456 extends from the proximal end of arcuate frame member 3441B. On the other hand, anchor member 3458 is part of a second set of anchor members that extend radially outward from the junction between the arcuate tip member and the longitudinal member. Specifically, each anchor member of the second set of anchor members extends from each junction between the proximal frame member of each arcuate petal-shaped portion and each longitudinal member. Thus, for example, anchor member 3458 extends from the junction between arcuate frame member 3441A and longitudinal member 3348A. In other embodiments, the anchor members may be disposed at other positions of the frame, including, alternatively or additionally, the proximal end of the proximal arcuate frame member (such as arcuate frame member 3441A) and the junctions formed between the distal arcuate frame member and the longitudinal member.

[0295] Figures 35A and 35B show another implant 3500 having an overall shape with different concave shapes. Implant 3500 includes a distal end 3502 and a proximal end 3504, and a longitudinal axis 3506 of implant 3500 extends between distal end 3502 and proximal end 3504. Implant 3500 includes a frame 3508 that can support a closure assembly 3510 at the distal end 3302. Figure 35A omits the closure assembly to more clearly show various features and configurations of frame 3508; Figure 35B includes closure assembly 3510. Similar to other embodiments described herein, closure assembly 3510 includes an inner sheet 3512, but may alternatively or additionally include a closure body. Implant 3500 may also include an outer sheet 3514 (also shown in Figure 35B) supported at the proximal portion of frame 3508, such that an annular opening 3516 is defined between inner sheet 3512 and outer sheet 3514.

[0296] The frame 3508 of the implant 3500 includes a distal frame portion 3518 that includes a set of circumferentially distributed arcuate petal-like portions, such as arcuate petal-like portion 3520A and arcuate petal-like portion 3520B (both labeled in FIG. 35A). The frame 3508 further includes an intermediate frame portion 3538 that includes a second set of circumferentially distributed arcuate petal-like portions, such as arcuate petal-like portion 3540A and arcuate petal-like portion 3540B (both labeled in FIG. 35A), and a proximal frame portion 3558 that includes a third set of circumferentially distributed arcuate petal-like portions, such as arcuate petal-like portion 3560A and arcuate petal-like portion 3560B (both labeled in FIG. 35A). As best seen in FIG. 35A, the first and second sets of arcuate petal-like portions are aligned to facilitate the joining of each arcuate petal-like portion of the first set of arcuate petal-like portions with each arcuate petal-like portion of the second set of petal-like portions. For example, the proximal end of arcuate petal-like portion 3520A is joined to the distal end of arcuate petal-like portion 3540A. In contrast, the second and third sets of arcuate petal-like portions are offset in the rotational direction and overlap each other in the longitudinal direction. For example, arcuate petal-like portion 3540A is offset in the rotational direction from arcuate petal-like portion 3560A and overlaps it in the longitudinal direction. Also, adjacent arcuate petal-like portions of the second and third sets may share a common frame element. For example, arcuate petal-like portion 3540A and arcuate petal-like portion 3560A each include frame element 3562.

[0297] Similar to the implant 3400 of FIG. 34 and the implant 2900C of FIG. 29C, the implant 3500 of FIGS. 35A and 35B has varying concave shapes. More specifically, the implant 3500 includes a proximal portion 3550 that is concave in the proximal direction, a distal portion 3552 that is concave in the distal direction, and a cap portion 3554 that is concave in the proximal direction.

[0298] Also, similar to implant 3400, implant 3500 includes circumferentially distributed anchor members, such as anchor member 3556. Anchor member 3556 is part of a set of anchor members that extend radially outward from each junction between adjacent arcuate petal-shaped portions of the third set of arcuate petal-shaped portions. Thus, for example, anchor member 3556 extends from junction 3564 between arcuate petal-shaped portion 3560A and arcuate petal-shaped portion 3560B. In other embodiments, the anchor members may alternatively or additionally be located at other positions of the frame, including junctions between adjacent arcuate petal-shaped portions of the second set of arcuate petal-shaped portions and proximal ends of the arcuate petal-shaped portions of the third set of arcuate petal-shaped portions.

[0299] Embodiments of the present disclosure corresponding to the implant 3500 are not limited to any size or dimension and may be modified or customized to meet the needs of the patient and specific applications. Nevertheless, in certain embodiments, the proximal radially outer edge 3563 of the inner sheet 3512 can be from about 16 mm to about 30 mm. For example, in one specific embodiment, the proximal radially outer edge 3563 can be 24 mm. Similarly, the distal radially inner edge 3565 of the outer sheet 3514 can be from about 35 mm to about 55 mm. For example, in one specific embodiment, the proximal radially inner edge 3563 can be 42 mm. The proximal radially outer edge 3566 of the implant 3500 can be from about 42 mm to about 68 mm. In one specific example, the proximal radially outer edge 3566 can be 56 mm. In embodiments where the implant 3500 includes an anchor member such as the anchor member 3556, at least a portion of the anchor member can be distributed around a common circumference 3567 of the implant 3500. The diameter of the common circumference 3567 can vary, but in at least certain embodiments, the common circumference 3567 can have a diameter from about 42 mm to about 68 mm. For example, the common circumference 3567 can have a diameter of 54 mm. As a final example, the overall height of the implant 3500 in the expanded state can vary, but in at least certain embodiments, the overall height of the implant 3500 can be from about 26 mm to about 48 mm and, in one specific embodiment, can be 36 mm.

[0300] Only some selected embodiments of the present disclosure are shown or described as including an anchor member (e.g., the projecting anchor member 105 of the frame 55), but such an anchor member may be added to any of the implant designs described herein or otherwise incorporated. Similarly, although the present disclosure describes the control of implant expansion by tension control lines with respect to FIGS. 12 - 22, such functionality may be adapted and incorporated into any of the other implants described herein.

[0301] X. Alternative Delivery Tool Structures Figures 36-38 illustrate a delivery device 3600 according to an alternative embodiment of the present disclosure. More specifically, FIGS. 36 and 37 are schematic views of the distal portion 3602 of the delivery device 3600 in a collapsed state and an expanded state, respectively, with the valve repair implant omitted for clarity. FIG. 38 is a photograph of the delivery device 3600, particularly a proximal view of the distal portion 3602 including the valve repair implant 3800 coupled to the delivery device 3600. The delivery device 3600 includes a plurality of variations to the mechanisms described earlier in the present disclosure, each of which is described in further detail below. In particular, the delivery device 3600 incorporates a plurality of mechanisms that are different from the previously disclosed embodiments, but each mechanism should be considered independent and, as a result, can be easily adapted for inclusion in other embodiments included in the present disclosure.

[0302] As shown in FIGS. 36-38, the delivery device 3600 includes a delivery catheter 3604 and an extension member 3606 extending from the distal portion 3602. In certain embodiments, as described in further detail below, the extension member 3606 can be selectively extended from and retracted into the delivery catheter 3604 during deployment of the valve repair implant 3800.

[0303] During deployment and implantation of the valve repair implant 3800, the valve repair implant 3800 is releasably coupled to the control arm assembly 3608 of the delivery device 3600. As described in further detail below, the control arm assembly can be operated to expand laterally or collapse inwardly with respect to the longitudinal axis 3603 of the delivery device 3600. Because the control arm assembly 3608 is coupled to the valve repair implant 3800, such expansion and collapse of the control arm assembly 3608 results in corresponding expansion and collapse of the valve repair implant 3800.

[0304] During delivery and deployment of the valve repair implant 3800, the valve repair implant 3800 can be coupled to the delivery device 3600 by a cinch line 3614 (shown in FIGS. 37 and 38). As shown, the cinch line 3614 forms a loop that extends distally from the delivery catheter 3604 and passes through a loop, ring, aperture, or similar mechanism of each of the control arm assembly 3608 and the valve repair implant 3800 to couple the valve repair implant 3800 to the control arm assembly 3608. In addition to coupling the valve repair implant 3800 to the delivery device 3600, the cinch line 3614 facilitates precise control of the expansion and collapse of the valve repair implant 3800 during deployment and implantation. In particular, the cinch line 3614 can be selectively tensioned to promote uniform expansion and collapse of the valve repair implant 3800.

[0305] FIGS. 39-44 are detailed views of the distal portion 3602 of the delivery device 3600 with various components of the delivery device 3600 selectively removed to further illustrate the structure and function of the delivery device 3600. FIGS. 39-44 are intended to introduce various internal components of the delivery device 3600, many of which will be described in further detail in later portions of the present disclosure.

[0306] FIG. 39 shows the delivery device 3600 with the delivery catheter 3604 and the sheath 3616 (shown in FIG. 38) removed. As shown, in at least certain embodiments, the delivery catheter 3604 can be covered by a tip or collar 3618 through which various components of the delivery device 3600 can pass. For example, each of the extension member 3606 and the control arm assembly (e.g., control arm assembly 3608) extends through the collar 3618, and this collar supports and maintains the relative positioning of the components of the delivery device 3600, such as the extension member 3606 and the control arm assembly 3608.

[0307] FIG. 39 further includes clamping line tubes 3620 and 3622, each of which extends through delivery catheter 3604 to guide and protect clamping line 3614. In certain embodiments, clamping line tubes 3620 and 3622 may be coiled tubes and may be coupled to or otherwise supported by control arm assembly 3608 such that clamping line tubes 3620 and 3622 extend from and retract into delivery catheter 3604 as control arm assembly 3608 expands and collapses. Alternatively, clamping line tubes 3620 and 3622 may be fixed and extend from delivery catheter 3604. In yet other embodiments, clamping line tubes 3620 and 3622 may be selectively extended and retracted by corresponding control mechanisms of a control assembly disposed at the proximal end of delivery catheter 3604.

[0308] FIG. 40 shows delivery device 3600 with clamping line 3614, clamping line tubes 3620, clamping line tubes 3622, and collar 3618 removed. As shown, delivery device 3600 may include support member 3624, which may be coupled to collar 3618 or may otherwise extend from collar 3618. Support member 3624 may have a cage-like structure that supports extension member 3606 and allows its longitudinal translation. Support member 3624 may further include a plurality of openings through which the control arm pair of control arm assembly 3608 may pass.

[0309] Figure 41 shows a delivery device 3600 with the support member 3624 removed. As shown, the delivery device 3600 can include a distal tube 3626 within which a proximal portion of the control arm assembly 3608 is translatable to selectively extend and retract the control arm assembly 3608. In certain embodiments, the distal tube 3626 may terminate or be covered by a diverter 3628 that directs a proximal arm (e.g., proximal arm 3634) of the control arm assembly 3608 at least partially in an out / in direction relative to the longitudinal axis 3603 of the delivery device 3600 to facilitate extension and retraction of the control arm assembly 3608. In addition to or instead of the diverter 3628, the proximal control arm of the control arm assembly 3608 may alternatively be curved outwardly or otherwise biased into an outwardly curved shape to facilitate extension and retraction of the control arm assembly 3608.

[0310] Figures 42 and 43 show the delivery device 3600 with the distal tube 3626 removed. In particular, FIG. 42 shows the delivery device 3600 with the control arm assembly 3608 in a retracted state, and FIG. 43 shows the delivery device 3600 with the control arm assembly 3608 in an extended state.

[0311] As shown, the control arm assembly 3608 can include a proximal portion 3630 that includes a proximal collar 3632 where a plurality of proximal arms (e.g., proximal arm 3634) begin to extend. The delivery device 3600 further includes a distal cap 3638 where a plurality of distal arms (e.g., distal arm 3640) of the control arm assembly 3608 begin to extend. In the present disclosure, as will be described in more detail later, each distal arm forms a control arm pair with one of the proximal arms, and each control arm pair can move between an extended state and a folded state by operating the control arm assembly 3608. In the specific embodiments shown in FIGS. 42 and 43, the operation of the control arm assembly 3608 includes driving the proximal portion 3630 in the proximal direction or retracting it in the distal direction using a control arm shaft 3642, which may be coupled to a control assembly of the delivery device 3600, and the control assembly includes a control mechanism suitable for selectively translating the control arm shaft 3642.

[0312] FIG. 44 shows the delivery device 3600 with the control arm assembly 3608 removed. As shown, the delivery device 3600 can include an extension member control rod 3644 that extends through the delivery catheter 3604 and is coupled to the extension member 3606 to facilitate extension and retraction of the extension member 3606 relative to the delivery catheter 3604. In at least some embodiments, the proximal end of the extension member control rod 3644 may be coupled to a control assembly at the proximal end of the delivery catheter 3604, and the control assembly includes a control element for selectively translating the extension member control rod 3644.

[0313] While considering the above as background information, the following portions of the present disclosure describe in more detail specific mechanisms of the delivery device 3600.

[0314] XI. Multi-Directional Steering As described with respect to FIGS. 11A - 11C, embodiments of the present disclosure may include a steerable delivery catheter. For example, the valve repair system 1100 shown in FIGS. 11A - 11C includes a catheter 1177 that can be steered using a steering control mechanism 1180 after being inserted into a patient via a sheath 1176. More specifically, catheter 1177 is illustrated and described as being steerable along a single plane between two ranges generally indicated by dashed outlines 1192A and 1192B. Thus, the embodiments shown in FIGS. 11A - 11C provide a single degree of freedom for steering catheter 1177.

[0315] Other embodiments of the present disclosure may include alternative delivery catheter structures that provide multiple degrees of freedom. For example, a delivery tool according to the present disclosure may be divided into a plurality of segments, each of which may be steerable along one or more planes. Such increased maneuverability, among other advantages, facilitates the guidance of the delivery tool to the implantation site and the final placement of the valve repair implant, ultimately resulting in a faster, more efficient, and more accurate implantation procedure.

[0316] FIG. 45A is a side view of a delivery device 3600 with the outer sheath removed and the implant 3800 in a deployed and expanded configuration. The delivery device 3600 includes a delivery catheter 3604, which in certain embodiments may be a steerable catheter. For example, the delivery device 3600 includes a distally steerable portion 4502 and a proximally steerable portion 4504, each of which may be steered independently from a control assembly (not shown) coupled to the proximal end of the delivery catheter 3604.

[0317] Similar to the distal portion of the catheter 1177 of the valve repair system 1100, the distally manipulable portion 4502 can be configured to bend along the plane 4506. For example, a control assembly coupled to the delivery catheter 3604 can include a knob, lever, arm, or similar control element attached to the distally manipulable portion 4502 by a cable, wire, or similar control line, and the operation of the control element is configured to bend the distally manipulable portion 4502 along the plane 4506 within a certain range of motion. The amount and range of bending can vary, but at least in certain embodiments, the distally manipulable portion 4502 can be configured to have a minimum bending radius of about 10 mm to about 20 mm along the plane 4506, and in one specific embodiment, it can have a minimum bending radius of about 15 mm. Further, in addition to including a control element adapted to manipulate the distally manipulable portion 4502, the control assembly can further include a mechanism (such as a knob, slide, button, etc.) for locking the angle of the distally manipulable portion 4502.

[0318] The proximal manipulable portion 4504 can be configured to bend along a plane 4508 that is planar when the delivery device 3600 is in a neutral / straight configuration. In at least some embodiments, the proximal manipulable portion 4504 can also be independently manipulable along a second plane, such as plane 4510. As shown, in at least certain embodiments, the plane 4510 can be orthogonal to the plane 4508. To effect manipulation of the proximal manipulable portion 4504, a control assembly coupled to the delivery catheter 3604 can include respective knobs, levers, arms, or similar control elements for each degree of freedom of the proximal manipulable portion 4504. Each such control element, in turn, can be attached to the proximal manipulable portion 4504 by a cable, wire, or similar control line such that operation of the control element causes the proximal manipulable portion 4504 to bend along the corresponding plane. The amount and extent of bending can vary, but in at least certain embodiments, the proximal manipulable portion 4504 can be configured to bend independently throughout each of the planes 4508 and 4510 and have a minimum bend radius of from about 20 mm to about 30 mm along each plane, and in one specific embodiment, can have a minimum bend radius of about 25 mm. The control assembly can further include respective mechanisms (e.g., knobs, slides, buttons, etc.) for locking each of the manipulation control mechanisms for the proximal manipulable portion 4504.

[0319] Figures 45B - 45H further illustrate the manipulation of the delivery device 3600. First, FIGS. 45B and 45C illustrate the manipulation of the distal manipulable portion 4502 of the delivery device 3600. More specifically, FIG. 45B shows the distal manipulable portion 4502 in a substantially neutral position, and FIG. 45C shows the manipulation of the distal manipulable portion 4502 along the plane 4506 (shown in FIG. 45A) to a first range. As shown in FIG. 45B, in at least certain embodiments, the distal manipulable portion 4502 may be manipulable about approximately 135° along the plane 4506; however, the present disclosure is not limited to a particular bending angle of the distal manipulable portion 4502. For example, in certain embodiments, the distal manipulable portion 4502 may be configured to bend up to 180° or more in a given direction. Moreover, FIG. 45C shows the manipulation of the distal manipulable portion 4502 in a first direction, but in embodiments of the present disclosure, the distal manipulable portion 4502 may be manipulable bidirectionally from the neutral state shown in FIG. 45B. In at least certain embodiments, the distal manipulable portion 4502 may be manipulable with a bend of approximately 360° along the plane 4506.

[0320] For example, in an embodiment where the delivery device 3600 is used for delivering an implant for tricuspid valve repair, the manipulation of the distal manipulable portion 4502 as shown in FIGS. 45B and 45C can be particularly useful for achieving the orthogonality between the longitudinal axis of the implant and / or between the distal manipulable portion 4502 and the valve annulus. More specifically, during the delivery of the implant into the right atrium, the physician generally feeds the delivery device 3600 through the inferior vena cava into the right atrium with the delivery device 3600 in the neutral state shown in FIG. 45B. After insertion into the right atrium, the physician can manipulate the distal manipulable portion 4502 to achieve and maintain substantial orthogonality between the distal manipulable portion 4502 and the implant and the tricuspid valve annulus until the delivery of the implant is complete.

[0321] The specific bending radius of the distally manipulable portion 4502 can vary based on the size and structure of the delivery device 3600, but in at least certain embodiments, the distally manipulable portion 4502 can be configured to have a minimum bending radius of about 12.5 mm. Nevertheless, the present disclosure contemplates that the overall size of the delivery device 3600 and the bending radius of the distally manipulable portion 4502 can vary based on the patient's anatomy and other considerations.

[0322] Figures 45D and 45E illustrate the manipulation of the proximally manipulable portion 4504 of the delivery device 3600. More specifically, Figure 45D shows the proximally manipulable portion 4504 in a substantially neutral position, and Figure 45E shows the proximally manipulable portion 4504 after being bent along the plane 4508 (shown in Figure 45A). As shown in Figure 45A, when the delivery device 3600 is in a neutral state, the plane 4506 and the plane 4508 are in the same plane.

[0323] Figure 45E shows how, in at least certain embodiments, the proximally manipulable portion 4504 can be manipulated about 45° along the plane 4508; however, the present disclosure is not limited to a particular bending angle of the proximally manipulable portion 4504 along the plane 4508. For example, in certain embodiments, the proximally manipulable portion 4504 can be configured to bend up to 60° or more in a given direction along the plane 4508. Also, similar to the distally manipulable portion 4502, the proximally manipulable portion 4504 can be manipulable in both directions along the plane 4508. In certain embodiments, the bending radius of the proximally manipulable portion 4504 along the plane 4508 can be from about 5 cm to about 7 cm, such as about 6 cm; however, the present disclosure is not limited to a particular bending radius of the proximally manipulable portion 4504 along the plane 4508.

[0324] Referring again to the procedure for delivery of the implant for tricuspid valve repair, manipulation of the proximal manipulable portion 4504 along the plane 4508 can be particularly useful when controlling the height / insertion of the implant and the distal manipulable portion 4502 relative to the valve annulus and when maximizing the use of atrial volume to properly align the implant with the valve annulus. For example, when the delivery device 3600 enters the right atrium via the inferior vena cava, the distal manipulable portion 4502 can be oriented such that the proximal manipulable portion 4504 and / or the distal manipulable portion 4502 extend partially laterally toward the atrial septum. In some cases, such an orientation can limit the range of motion of the distal manipulable portion 4502 and, as a result, limit the ability of the physician to align the distal manipulable portion 4502 with the valve annulus by manipulating only the distal manipulable portion 4502. To increase the range of motion of the distal manipulable portion 4502, as shown in FIG. 45E, the proximal manipulable portion 4504 can be maintained near or along the inner surface of the right atrium, thereby increasing the available right atrial volume within which the distal manipulable portion 4502 can be manipulated and maneuvered by manipulating the proximal manipulable portion 4504.

[0325] Finally, FIGS. 45F - 45H illustrate manipulation of the proximal manipulable portion 4504 of the delivery device 3600. More specifically, FIG. 45F shows the proximal manipulable portion 4504 in a substantially neutral position, and FIG. 45G shows the proximal manipulable portion 4504 after being bent along the plane 4510 (shown in FIG. 45A). As shown in FIG. 45A, when the delivery device 3600 is in a neutral state, the plane 4510 is orthogonal to the planes 4506 and 4508, respectively.

[0326] FIG. 45G shows the proximal manipulable portion 4504 bent in a first direction along the plane 4510 from the neutral state shown in FIG. 45F, and FIG. 45H shows the proximal manipulable portion 4504 bent in a second direction opposite to the first direction along the plane 4510 from the neutral state. In the specific embodiments shown in FIGS. 45F-45H, the bending of the proximal manipulable portion 4504 along the plane 4510 is up to about 30° in either direction; however, the present disclosure is not limited to a specific bending angle of the proximal manipulable portion 4504 along the plane 4508. More generally, in certain embodiments, the proximal manipulable portion 4504 can be configured to bend up to about 60° or more in one or both directions relative to neutral along the plane 4510.

[0327] When used to deliver an implant for tricuspid valve repair, the manipulation of the proximal manipulable portion 4504 along the plane 4510 can be particularly useful for suppressing the offset of the implant relative to the tricuspid annulus. After the physician has successfully positioned the implant using the delivery device 3600, the physician can generally align the implant orthogonal to the annulus of the tricuspid valve by manipulating the distal manipulable portion 4502 along the plane 4506 and the proximal manipulable portion 4504 along the plane 4508. Despite being oriented in the orthogonal direction, the implant may not be properly aligned with the annulus. For example, the longitudinal axis of the implant may be offset relative to the longitudinal axis of the annulus. In such a case, the manipulation of the proximal manipulable portion 4504 along the plane 4510 can be used to reposition the implant to reduce the offset while maintaining the orthogonality of the implant relative to the annulus.

[0328] FIGS. 46-49 are photographs of a portion of the steering control assembly 4600 for the delivery device 3600, specifically, a portion of the steering control assembly 4600 that includes the steering control mechanism. As described above, the steering control assembly 4600 can be coupled to the proximal end of the delivery catheter 3604.

[0329] Figure 46 is an elevation view of a steering control assembly 4600 that includes a first steering portion 4602, a second steering portion 4604, and a third steering portion 4606. The functions of each steering portion will be described in further detail below; in the specific embodiments shown in FIGS. 46-49, the first, second, and third steering portions generally correspond to a "main" steering mechanism, a "depth" steering mechanism, and an "offset" steering mechanism, respectively, as labeled in the figures and described in further detail below.

[0330] Figure 47 is a detailed view of a first steering portion 4602, also referred to herein as the main steering mechanism. The first steering portion 4602, when used in conjunction with the delivery device 3600, can control the steering / bending of the distal steerable portion 4502 along the plane 4506. In at least certain embodiments, such movement corresponds to the inward and outward steering movement at the distal end of the delivery catheter 3604. As shown in FIG. 47, the first steering portion 4602 can include a steering lever 4608 that can be operated to steer the distal steerable portion 4502, and a lock knob 4610 for locking the position of the steering lever 4608 and, as a result, the orientation of the distal steerable portion 4502 in the plane 4506.

[0331] Figure 48 is a detailed view of a second steering portion 4604, also referred to herein as the depth steering mechanism. The second steering portion 4604, when used in conjunction with the delivery device 3600, can control the steering / bending of the proximal steerable portion 4504 along a plane 4508 that is in the same plane as the plane 4506 (i.e., the plane of movement of the distal steerable portion 4502) when the delivery catheter 3604 is in a neutral configuration. In at least certain embodiments, such movement corresponds to the upward and downward steering movement at the distal end of the delivery catheter 3604. As shown in FIG. 48, the second steering portion 4604 can include a steering lever 4612 that can be operated to steer the proximal steerable portion 4504, and a lock knob 4614 for locking the position of the steering lever 4612 and, as a result, the orientation of the proximal steerable portion 4504 in the plane 4508.

[0332] FIG. 49 is a detailed view of a third steering portion 4606, also referred to herein as an offset steering mechanism. The third steering portion 4606, when used in conjunction with the delivery device 3600, can control the steering / bending of the proximal steerable portion 4504 along a plane 4510 that is orthogonal to the plane 4508. In at least certain embodiments, such movement corresponds to rearward and forward steering movements at the distal end of the delivery catheter 3604. As shown in FIG. 49, the first steering portion 4602 includes a steering lever 4616 that can be operated to steer the proximal steerable portion 4504, and a lock knob 4618 for locking the position of the steering lever 4616 and, as a result, the orientation of the proximal steerable portion 4504 in the plane 4510.

[0333] The steering control assembly 4600 is merely an exemplary embodiment of a control assembly that can be used in conjunction with the delivery device 3600 and other delivery devices in accordance with the present disclosure. Among other things, the number of steerable portions, the orientation and degrees of freedom of each steerable portion, the range of each steerable portion, and the orientation and other aspects of the steering control assembly 4600 and its functionality can vary. Also, the structure and arrangement of the steering control assembly 4600 shown in FIGS. 46 - 49 are non-limiting, and other arrangements of the control assembly components are considered to be fully within the scope of the present disclosure.

[0334] XII. Extendable Sheath During delivery of the valve repair implant 3800, the implant 3800 is coupled to the distal end of the delivery device 3600, more specifically, to the distal end of the delivery catheter 3604 of the delivery device 3600. To maintain the implant 3800 in a collapsed state and facilitate the guidance of the delivery device 3600 and the implant 3800 to the implantation position, the delivery device 3600 can include a sheath that extends along the outer surface of the delivery catheter 3604. For example, FIG. 50 is a photograph of a delivery device 3600 that includes a sheath 3616 disposed on the delivery catheter 3604 and the implant 3800.

[0335] In at least certain embodiments, the sheath 3616 is translatable relative to the delivery catheter 3604. For example, the sheath 3616 is translatable from an extended configuration to a retracted configuration. In the extended configuration, the sheath 3616 can extend beyond the distal end of the delivery catheter 3604 such that it covers and at least partially houses the implant 3800. After delivery of the implant 3800 to the implantation region (e.g., in the atrium), the sheath 3616 can be retracted, thereby enabling deployment of the implant 3800. In at least certain embodiments, the sheath 3616 may also be configured to extend distally again after deployment and release of the implant 3800. In particular, such re-extension of the sheath 3616 enables accommodation of the distal portion of the delivery device 3600 for retraction and removal from the patient.

[0336] In at least certain embodiments, the sheath 3616 can include one or more embedded radiopaque markers. For example, FIG. 51 is an x-ray image of a delivery tool 5100 according to the present disclosure. As shown, the delivery tool 5100 includes a sheath 5102, which further includes a radiopaque marker in the form of a band 5104 embedded within the distal portion 5106 of the sheath 5102 (however, other radiopaque markers such as beads, strips, coils, etc. are also contemplated).

[0337] Figures 52 and 53 are photographs of a portion of a sheath control assembly 5200 showing exemplary embodiments of a sheath control mechanism that can be used in conjunction with delivery device 3600. Sheath control assembly 5200 includes a knob 5202 that can be rotated to extend and retract sheath 3616; in other embodiments, knob 5202 may be replaced with a lever, slide, or similar control element. As shown in FIG. 53, sheath control assembly 5200 may further include a flush port 5204 that communicates with the internal volume of sheath 3616 to facilitate flushing of sheath 3616. Sheath control assembly 5200 may further include a window 5206 and an indicator 5208 or similar markings for communicating the position of sheath 3616. For example, the proximal end of sheath 3616 can be viewed through window 5206, and indicator 5208 can be in the form of a line, groove, mark, etc. disposed adjacent to window 5206, and the proximal end of sheath 3616 can be aligned with this line, groove, mark, etc. to indicate the position of sheath 3616.

[0338] In at least certain embodiments, sheath 3616 and sheath control assembly 5200 can be configured to allow movement of about 5 cm to about 12 cm. For example, in at least one embodiment, sheath 3616 can be retracted up to 8 cm from its fully extended configuration. As shown, sheath control assembly 5200 does not include a locking mechanism for locking the position of sheath 3616; in other embodiments, sheath control assembly 5200 may include a locking mechanism (e.g., a knob, clamp, pin, etc.) for locking the position of sheath 3616, for example, by positively engaging a portion of sheath 3616 with sheath control assembly 5200 or by preventing operation of the control element of sheath control assembly 5200 for extending and retracting sheath 3616.

[0339] XIII. Implant Extension and Retraction During delivery of the implant 3800, the implant 3800 is maintained in a folded configuration and may be at least partially covered by the sheath 3616. The implant 3800 may also be disposed partially or entirely within the delivery catheter 3604 during delivery. Thus, it may be necessary to deploy the implant 3800 from the delivery catheter 3604 after delivery into the patient's heart and prior to final placement. Deployment of the implant 3800 may include extending the implant 3800 distally from the delivery catheter 3604 in addition to retracting the sheath 3616. Once released from the delivery catheter 3604 and sheath 3616, the implant 3800 may selectively expand, fold, and be positioned for implantation.

[0340] Due to the shape and structure of the implant 3800, the overall length of the implant 3800 when folded may be substantially longer than the overall length of the implant 3800 when expanded. To facilitate improved placement and implantation of the implant 3800, the delivery device according to the present disclosure may include a mechanism for extending the implant 3800 from the delivery catheter 3604 to a first range for deployment. After deployment, the mechanism may allow for at least partial extension release / retraction of the implant 3800 to reduce the total overall length between the distal portion 3602 of the delivery device 3600 and the implant 3800. Considering the limited space in the atrium, such a reduction in the total overall length of the delivery device 3600 and the implant 3800 can provide substantially increased operability and control of the delivery device 3600 and the implant 3800, leading to more rapid and accurate implant placement.

[0341] In certain embodiments, the extension and retraction of the implant 3800 relative to the delivery catheter 3604 can be achieved by extending and retracting the extension member 3606 relative to the delivery catheter 3604. As described with respect to FIGS. 36-38, the extension member 3606 extends distally from the delivery catheter 3604 and supports the distal control arm of the control arm assembly. During delivery, the implant 3800 is attached to the delivery device 3600 by coupling the implant 3800 to the control arm assembly. Thus, when the control arm assembly is coupled to the extension member 3606, extension and retraction of the extension member 3606 relative to the delivery catheter 3604 also results in extension and retraction of the implant 3800 relative to the delivery catheter 3604 when the implant 3800 is attached to the delivery device 3600.

[0342] Figures 54A and 54B are photographs of delivery device 3600 with implant 3800 attached. Specifically, FIG. 54A shows delivery device 3600 and implant 3800 in a fully extended configuration. As described above, the fully extended configuration can be used to facilitate initial deployment of implant 3800, for example, by fully separating implant 3800 from sheath 3616 (not shown) and delivery catheter 3604. To achieve the fully extended configuration, after guiding the distal portion 3602 of delivery device 3600 and implant 3800 into the atrium, delivery device 3600 is actuated to extend extension member 3606 distally relative to delivery catheter 3604, thereby enabling deployment and expansion of implant 3800. After deployment and expansion, extension member 3606 can be at least partially retracted relative to delivery catheter 3604 to produce the retracted / extension release configuration of FIG. 45B. In at least certain embodiments, extension member 3606 is subjected to a movement of about 15 mm to about 25 mm relative to delivery catheter 3604, and the possible retraction / extension release can be configured to include from about 50% to about 80% of the total travel distance of extension member 3606. For example, in one specific embodiment, extension member 3606 can be configured to have a total travel of about 20 mm after deployment of implant 3800, with at least 12 mm of retraction / extension release available.

[0343] FIG. 55 is a photograph of a portion of deployment control assembly 5500 showing an exemplary embodiment of an extension / extension release control mechanism that can be used in conjunction with delivery device 3600. Deployment control assembly 5500 includes an extension handle 5502 that can be rotated to extend and retract extension member 3606; in other embodiments, extension handle 5502 may be replaced with a lever, slide, knob, or similar control element.

[0344] XIV. Control Arm Assembly and Clamping Line Retrieval As described above, the control arm assembly 3608 enables selective expansion and folding of the implant 3800 during deployment and implantation of the implant 3800. To do so, the control arm assembly 3608 includes a plurality of control arm pairs, each control arm pair including a proximal arm and a distal arm. Each proximal arm is configured to be biased, deflected, or otherwise configured such that when the proximal arm extends distally from the delivery catheter 3604, the proximal arm extends at least partially in an out / in direction relative to the longitudinal axis 3603 of the delivery device 3600. The distal portion of each proximal arm is coupled to the proximal portion of the respective distal arm such that the distal arm extends in a similar out / in direction based on the extension of the proximal arm. The distal arms generally provide support and stability to the proximal arms; in certain embodiments, the proximal portion of the distal arm may also include a ring, loop, aperture, or similar feature through which the tightening line 3614 may pass to couple the implant 3800 to the delivery device 3600.

[0345] Figures 56 and 57 show the distal portion 3602 of the delivery device 3600 with the control arm assembly 3608 in a folded state and an expanded state, respectively. The following description primarily describes the operation of the control arm assembly 3608 by reference to the proximal arm 3634 and the distal arm 3640. Such reference is for clarity and brevity only. Unless otherwise specified, reference to the proximal arm 3634 and the distal arm 3640 should generally be considered to apply to the other proximal and distal arms of the control arm assembly 3608 as well.

[0346] As shown in FIG. 56, when in the folded state, the proximal arm 3634 and the distal arm 3640 are substantially flat and parallel to the longitudinal axis 3603 of the delivery device 3600. For example, when the control arm assembly 3608 is expanded by pushing the proximal portion 3630 of the control arm assembly 3608 with the control arm shaft 3642 as described with respect to FIGS. 42 and 43, the distal portion 3636 of the proximal arm 3634 moves partially outward. In certain embodiments, the outward movement of the distal portion 3636 results from the proximal arm 3634 having a shape that is curved outwardly or being biased in an outwardly curved direction. Alternatively or additionally, the delivery device 3600 may include a diverter or similar structural element (e.g., the diverter 3628 shown in FIG. 41) that directs the proximal arm 3634 outwardly as the proximal arm 3634 extends from the delivery catheter 3604, as shown in FIG. 57.

[0347] Since the distal portion 3636 of the proximal arm 3634 is coupled to the proximal portion 3641 of the distal arm 3640, an outward force is applied to the proximal portion 3641 of the distal arm 3640 by the extension of the proximal arm 3634 from the delivery catheter 3604. In the embodiments shown in FIGS. 56 and 57, the distal portion 3643 of the distal arm 3640 is fixed to the distal cap 3638 of the extension member 3606. Thus, when an outward force is applied to the proximal portion 3641 of the distal arm 3640, the distal portion 3643 of the distal arm 3640 bends outward. In other embodiments, the distal arm 3640 may instead be coupled to the distal cap 3638 by a hinge or similar movable joint that allows outward movement of the proximal portion 3641 of the distal arm 3640 without substantial bending.

[0348] The folding of the control arm assembly 3608 can be achieved by retracting the proximal portion 3630 of the control arm assembly 3608, which in turn causes the proximal arm 3634 to be retracted into the delivery catheter 3604. Here again, since the distal portion 3636 of the proximal arm 3634 is coupled to the proximal portion 3641 of the distal arm 3640, the retraction of the proximal arm 3634 into the delivery catheter 3604 applies an inward force to the proximal portion 3641 or the distal arm 3640, thereby causing the distal arm 3640 to return to its folded configuration.

[0349] FIG. 58 shows in more detail an exemplary coupling device between the proximal arm 3634 and the distal arm 3640. As shown, the distal portion 3636 of the proximal arm 3634 can include a first mechanism, such as a protrusion 3637, which is formed to be inserted into and thereby retained by a second mechanism, such as an opening 3639 in the distal arm 3640. For example, FIG. 58 shows the protrusion 3637 as T-shaped, dog-bone shaped, or barb-shaped, and the opening 3639 as an oval slot. Thus, by rotating the protrusion 3637 by 90°, inserting it into the opening 3639, and then reversing the rotation to hold the protrusion 3637 by the opening 3639, the distal portion 3636 can be coupled to the distal arm 3640. In other embodiments, the protrusion and the opening can be reversed, such that a protrusion on the distal arm 3640 extends through an opening in the proximal arm 3634 and is thereby retained. It is noted that the present disclosure contemplates other coupling devices between the proximal arm 3634 and the distal arm 3640, and any coupling that enables the movement of the proximal arm 3634 relative to the distal arm 3640 necessary for the expansion of the control arm assembly 3608 can be used in place of the specific coupling device shown in FIG. 58.

[0350] FIG. 59 is a detailed view of the coupling between the control arm assembly 3608 and the implant 3800. As described above, the coupling of the delivery device 3600 to the implant 3800 is by a tightening line 3614, which passes through the delivery device 3600 and forms a loop around the inner circumference of the implant 3800. More specifically, the tightening line 3614 extends through the delivery catheter 3604 (e.g., through the tightening line tube 3620). The tightening line 3614 is then passed through openings extending around each of the control arm assembly 3608 and the implant 3800. The tightening line 3614 is then returned through the delivery catheter 3604 (e.g., through the tightening line tube 3622) to the proximal end of the delivery catheter 3604.

[0351] In certain embodiments, the opening of the implant 3800 can be in the form of a hoop, loop or ring (e.g., ring 3804) extending around the inner surface 3802 of the implant 3800. Similarly, the opening of the control arm assembly 3608 can be in the form of a hoop, loop or ring (e.g., ring 3646) coupled to the control arm assembly 3608. For example, in the embodiment of FIG. 58, the ring 3646 is attached to and extends from the proximal portion 3641 of the distal arm 3640. In other embodiments, the distal arm 3640 or distal portion 3636 can define and include an integrally formed hole, port or similar opening that functions as an opening through which the tightening line 3614 extends.

[0352] By passing the tightening line 3614 through each opening of the control arm assembly 3608 and each opening of the implant 3800, the implant 3800 can be coupled to the delivery device 3600. Additionally, such an arrangement also enables the tightening line 3614 to provide further control and uniformity when the implant 3800 is expanded and folded during deployment and implantation. For example, when the tightening line 3614 extends around the implant 3800, applying tension to the tightening line 3614 creates an inward pulling force that is distributed around the implant 3800. When the implant 3800 is folded, this distributed inward force promotes the uniform folding of the implant 3800, thereby improving the control and prediction accuracy during the folding of the implant 3800. The distributed inward force can also act as a reaction force when expanding the implant 3800, which also promotes the uniform expansion of the implant 3800 and improves the control and prediction accuracy of implant expansion.

[0353] In certain embodiments of the present disclosure, the delivery device 3600 may include a control assembly that includes control elements for adjusting the expansion and folding of the control arm assembly 3608 and the operation of the tightening line 3614. Referring again to FIG. 55, for example, the deployment control assembly 5500 includes an expansion handle 5504 that can be rotated to selectively expand and fold the implant 3800 when the implant 3800 is coupled to the control arm assembly 3608. For example, rotation of the expansion handle 5504 can translate the control arm shaft 3642 relative to the delivery catheter 3604. As described above, such translation can push or pull the proximal portion 3630 of the control arm assembly 3608, thereby causing the expansion of the control arm assembly 3608. In other embodiments, the expansion handle 5504 may be replaced with other control elements such as a lever, knob, or similar component for selectively translating the control arm shaft 3642 relative to the delivery catheter 3604.

[0354] The deployment control assembly 5500 further includes a tensioner 5506 for controlling the tension of the clamping line 3614. When assembled, the tensioner 5506 is coupled to the first end of the clamping line 3614, and the second end of the clamping line 3614 can be fixed to another point on the deployment control assembly 5500. The tensioner 5506 can be selectively movable, for example, along a rail 5508 so as to increase the tension of the clamping line 3614 by translating the tensioner 5506 in the proximal direction. Conversely, the tension can also be reduced by translating the tensioner 5506 in the distal direction.

[0355] In at least certain embodiments, the implant 3800 is released from the delivery device 3600 by severing the clamping line 3614 in the deployment control assembly 5500 and then withdrawing the clamping line 3614 from the delivery catheter 3604.

[0356] XV. Control Assembly and Attachment The previous part of the present disclosure describes alternative forms of the control assembly of the delivery device 3600. Generally, such a control assembly provides various control elements for operating the various components of the delivery device 3600. In particular, such control elements include elements for extending and retracting the sheath 3616, elements for manipulating the delivery catheter 3604, elements for extending and retracting the extension member 3606, elements for expanding and collapsing the control arm assembly 3608, and elements for controlling the tension of the clamping line 3614.

[0357] FIG. 60 is a photograph showing the proximal portion of the delivery device 3600, particularly the control assembly 6000 of the delivery device 3600. As shown, the control assembly 6000 is a combination of the various control assembly portions described above in the present disclosure. For example, the control assembly 6000 is a combination of a sheath control assembly 5200, a steering control assembly 4600, and a deployment control assembly 5500 (from the most distal to the most proximal), respectively. In particular, the control assembly 6000 is only intended as an exemplary control assembly for use with a delivery device according to the present disclosure that provides various functions for delivering, deploying, and implanting a valve repair implant. Although not specifically shown, other embodiments of the control assembly may include, among other things, alternative structures of the control assembly portions and additional structural elements (such as an outer housing, a grip, etc.).

[0358] FIG. 61 is a photograph showing an exemplary attachment device of the delivery device 3600 including the control assembly 6000. In the exemplary structure, the control assembly 6000 is received within a mount 6050 that is coupled to and supported by a rail 6052. The rail 6052, on the other hand, is coupled to a multi-joint arm 6060, and the joint arm may be fixed to a bed, a table, a support stand, or a similar stable structure.

[0359] Although other attachment structures are contemplated, the structure shown in FIG. 61 is advantageous in that it provides two additional degrees of freedom for the delivery device 3600. First, the mount 6050 includes a rotating cradle 6054 that receives the delivery device 3600. Second, the mount 6050 is coupled to the rail 6052 by a stepper-type mount such that the insertion of the delivery device 3600 can be controlled by a knob 6056. The mount 6050 may further include an additional control mechanism for locking the position of the rotating cradle 6054 and the mount 6050 on the rail 6052.

[0360] XVI. Exemplary Implantation Process To provide further details and background information on the various mechanisms described in the previous section, FIG. 62 is a block diagram showing a method 6200 of implanting implant 3800 using delivery device 3600.

[0361] In step 6202, the implant 3800 is delivered to the patient's atrium, for example, via a antegrade percutaneous route (e.g., a transfemoral route or a transjugular route). During delivery, the implant 3800 is coupled to the distal end of the delivery device 3600 by a clamping line 3614, and a sheath 3616 covers the distal end of the delivery device 3600, including at least a portion of the implant 3800. As described above, coupling the implant 3800 to the delivery device 3600 may include passing the clamping line 3614 through a first set of apertures disposed on the inner circumference of the implant 3800, for example, a series of loops or rings distributed on the inner circumference of the implant 3800. The clamping line 3614 is further passed through a second set of apertures of the control arm assembly 3608, thereby coupling the implant 3800 to the control arm assembly 3608 using the clamping line 3614. In at least some embodiments, the apertures of the control arm assembly 3608 may be rings coupled to the proximal portion of the distal control arm of the control arm assembly 3608. For example, FIG. 59 shows a ring 3646 coupled to the proximal portion 3641 of the distal arm 3640.

[0362] In at least some embodiments, guiding the delivery device 3600 and the implant 3800 to the implantation site may include passing the delivery device 3600 along a guide wire previously inserted into the patient and extending to the atrium.

[0363] Step 6204 includes retracting the sheath 3616 to facilitate subsequent deployment of the implant 3800. As described in the previous section, retracting the sheath 3616 may include operating the control mechanism of the control assembly 6000 to translate the sheath 3616 in a proximal direction relative to the delivery catheter 3604.

[0364] Step 6206 includes deploying the implant 3800. Deploying the implant 3800 generally refers to the process of moving the implant 3800 away from the sheath 3616 and the delivery catheter 3604 to allow the implant 3800 to be free to expand, collapse, and be positioned for implantation. Deploying the implant 3800 may include partially expanding the implant 3800, for example, by expanding the control arm assembly 3608. For example, a user may partially expand the control arm assembly 3608 by turning a corresponding handle or knob of the control assembly 6000. Deploying the implant 3800 may also include at least partially extending the implant 3800 distally relative to the delivery catheter 3604. In at least some embodiments, extending the implant 3800 may include extending the extension member 3606 distally relative to the delivery catheter 3604 using a corresponding control mechanism of the control assembly 6000.

[0365] Step 6208 includes retracting / de-extending the implant 3800 relative to the delivery catheter 3604 after at least partial expansion of the implant 3800. As previously mentioned, in certain embodiments, initial deployment of the implant 3800 may require the implant 3800 to extend to a first distal extent beyond the delivery catheter 3604, for example, to allow the implant 3800 to clear the sheath 3616 and delivery catheter 3604. However, once deployed, the implant 3800 may be longitudinally retracted / de-extended to make the combination of the distal portion of the delivery device 3600 and the implant 3800 more compact. Among other things, a more compact configuration improves maneuverability of the implant 3800 within the heart, thereby increasing speed and precision in positioning and implanting the implant 3800.

[0366] Step 6210 includes positioning to implant implant 3800. In at least certain embodiments, positioning the implant 3800 includes positioning the implant 3800 such that the occluding element of the implant 3800 is at the height of the native valve leaflet or otherwise in a position to contact and interact with the valve leaflet. During certain procedures, positioning the implant 3800 can include further expansion, folding, and / or movement of the implant 3800 to achieve the correct positioning. Thus, step 6210 can include expansion / folding of the control arm assembly 3608, extension / retraction of the extension member 3606, manipulation of the delivery catheter 3604, or any other articulation of the delivery device 3600 necessary to correctly position the implant 3800 within the heart.

[0367] Step 6212 includes fully expanding the implant 3800 after the implant 3800 has been positioned in the implant position. Full expansion of the implant 3800 can include expanding the control arm assembly 3608 to its maximum or near maximum extent. In particular, in most applications, when the implant 3800 is correctly positioned relative to the heart valve, such expansion interferes with and engages the implant 3800 with the heart tissue. For example, the implant 3800 can include outwardly projecting protrusions that are formed and positioned to engage the tissue adjacent to the valve.

[0368] Step 6214 includes releasing the implant 3800 from the delivery device 3600. Releasing the implant 3800 from the delivery device 3600 includes detaching the implant 3800 from the delivery device 3600 by removing the clamping line 3614. For example, after the clamping line 3614 is cut in the control assembly 6000, it can be pulled out from the delivery device 3600. When being pulled out, the cut end of the clamping line 3614 passes through the control arm assembly 3608 and the opening of the implant 3800, and as a result, the implant 3800 is detached from the control arm assembly 3608.

[0369] Step 6216 includes preparing to retract and remove the delivery device 3600 from the patient. Generally, preparing the delivery device 3600 includes folding the delivery device 3600 to its maximum extent and housing the distal portion 3602 of the delivery device 3600. For example, preparing the delivery device 3600 for retraction includes fully folding the control arm assembly 3608, retracting / extending the extension member 3606, and extending the clamping line 3614 again onto the distal end of the delivery device 3600.

[0370] Step 6218 includes retracting the delivery catheter 3604 from the patient to substantially complete the implantation process.

[0371] XVII. Further alternative implant and closure plug designs Figures 63A - 64N show an implant 6300 according to another embodiment of the present disclosure. Specifically, Figure 63A is a perspective view of the proximal side (atrial side when implanted) of the implant 6300, and Figures 63B and 63C are perspective and plan views, respectively, of the distal side of the implant 6300. Figure 63D is the same as Figure 63C but with various dimensions marked. Figures 64A - 64P show the frame 6355 of the implant 6300 and various details of the frame 6355. Figures 63A - 63C show the implant 6300 in an expanded state, such as when implanted in a heart valve to be repaired.

[0372] As shown in FIGS. 63A - 63D, the implant 6300 generally includes a distal end 6340 and a proximal end 6345. The distal end 6340 acts as the tip of the implant 6300 during implantation and faces the ventricle after implantation into the valve annulus. The implant 6300 further includes a closure plug 6302 disposed at the distal end 6340. The closure plug 6302 is coupled to and supported on the frame 6355. In contrast to the previous closure plugs disclosed herein, including bulbous closure plugs (including those having a sheet - type skirt) and sheet - type closure plugs, the closure plug 6302 is a cap - type closure plug formed by laminating a plurality of material sheets around the distal portion of the frame 6355. The implant 6300 further includes an outer sheet 6360 supported by the frame 6355. When in the expanded state, the frame 6355 radially expands laterally outwardly relative to 370 (shown in FIGS. 63A and 63B) of the implant 6300, the closure plug 6302 forms a distal surface 6361, and the outer sheet 6360 forms an annular surface 6364. Further details regarding the closure plug 6302 and the outer sheet 6360 are shown and described below with reference to FIGS. 65A - 65F for the closure plug 6302 and FIGS. 66A - 67 respectively.

[0373] The distal surface 6361 formed by the closure plug 6302 includes a proximal radially outer edge 6363, and the annular surface 6364 of the outer sheet 6360 forms a distal radially inner edge 6365 and a proximal radially outer edge 6366 respectively. The proximal radially outer edge 6363 of the distal surface 6361 and the distal radially inner edge 6365 of the annular surface 6364 define an opening 6367 between the closure plug 6302 and the outer sheet 6360.

[0374] Similar to the previous implants of the present disclosure, the implant 6300 can be transitioned into a folded state for delivery to a target implantation site. When folded, the frame 6355, the closure plug 6302, and the outer sheet 6360 can be folded symmetrically about the central longitudinal axis 6370. Also, similar to the previous implants of the present disclosure, the frame 6355 can bias the implant 6300 to expand itself into an expanded state, for example, to fix itself within the target heart valve annulus.

[0375] Each of the closure plug 6302 and the outer sheet 6360 is supported on the frame 6355. In the illustrated specific example, the closure plug 6302 is coupled to and supported on the frame 6355 by an adhesion and lamination process. More specifically, at least one first layer of the closure plug 6302 is disposed on the distal surface of the 6355, and at least one second layer of the closure plug 6302 is disposed on the proximal surface of the frame 6355. Subsequent layer adhesion (for example, by application of epoxy or other adhesives, heating, etc.) forms the closure plug 6302 and at the same time couples the closure plug 6302 to the frame 6355. In contrast, the outer sheet 6360 is shown as being coupled to the frame 6355 by a distal radially inner edge 6365, a proximal radially outer edge 6366, and a suture extending along the frame 6355. The lamination of the closure plug 6302 and the suturing of the outer sheet 6360 to the frame 6355 will each be described in more detail below.

[0376] Embodiments of the present disclosure are not strictly limited to a particular size or dimension and can be modified or customized to meet the needs of the patient and the specific application. Nevertheless, without being limited to the scope of the present disclosure, specific examples of dimensions are provided and shown in FIG. 63D.

[0377] In a particular embodiment, the closure plug 6302 can have a diameter (D1) of about 16 mm to about 28 mm, and the maximum diameter generally corresponds to the diameter of the closure plug 6302. For example, the closure plug 6302 can have a maximum diameter of about 22 mm.

[0378] In other embodiments, the outer sheet 6360 may have an inner diameter (D2) of about 36 mm to about 46 mm (e.g., the diameter of the distal radially inner edge 6365). For example, the distal radially inner edge 6365 may have a diameter of about 41 mm.

[0379] As shown in FIG. 63D, each of the outer sheet 6360 and the frame 6355 may have a proximal edge that is sinusoidal or varies in some other way. In such embodiments, the proximal radially outer end 6363 may be defined by a minimum diameter (D3) and a maximum diameter (D4), respectively. In particular, the varying proximal edge balances secure fixation of the implant within the valve annulus and reduced interference between the implant and the native heart structure. More specifically, the sinusoidal proximal edges of the frame 6355 and the outer sheet 6360 provide more secure fixation and support by allowing the frame 6355 to extend and distribute over a wider area around the valve annulus. In contrast, the sinusoidal edge of the frame 6355 reduces the proximal portion of the outer sheet 6360 compared to a similar structure having the same maximum diameter but a circular proximal edge, thereby reducing the risk of interference between the implant 6300 and other heart structures.

[0380] In view of the foregoing, in at least certain embodiments, the minimum diameter (D3) of the proximal radially outer edge 6363 may be from about 48 mm to about 68 mm. For example, the minimum diameter of the proximal radially outer edge 6363 may be about 58 mm. Similarly, the maximum diameter (D4) of the proximal radially outer edge 6363 may be from about 58 mm to about 78 mm, but at least as large as the minimum diameter of the proximal radially outer edge 6363. For example, in one particular example, the maximum diameter of the proximal radially outer edge 6363 may be about 68 mm.

[0381] This disclosure describes that a sinusoidal or varying structure of the proximal radially outer edge 6363 provides certain advantages, but such a structure is not essential and embodiments of the disclosure are not limited to a structure where the proximal radially outer edge 6363 varies. Thus, although not specifically shown with respect to the implant 6300, the disclosure also contemplates that the proximal radially outer edge 6363 of the implant 6300 can be of a constant diameter / circular shape.

[0382] The height of the implant 6300 is generally defined as the distance between the distal extent 6375 of the proximal radially outer edge 6363 and the proximal extent. Similar to other aspects of the implant 6300, the height of the implant 6300 can vary, for example, to accommodate changes in the patient's anatomical structure. However, in at least certain embodiments, the overall height of the implant 6300 can be from about 15 mm to about 25 mm. For example, the overall height of the implant 6300 can be about 20 mm.

[0383] Further details regarding the structure of the implant 6300 are provided with reference to FIGS. 64A - M, which show the frame 6355 in detail. More specifically, FIG. 64A is a distal isometric view of the frame 6355, FIG. 64B is a distal elevation view of the frame 6355, and FIG. 64C is an elevation view of the frame 6355. FIGS. 64D and 64E are views of the frame 6355 showing specific mechanisms and elements of interest. FIGS. 64F - 64K are detailed views of those mechanisms. FIGS. 64L and 64M are side / elevation views of the frame 6355, and FIG. 64N is a detailed view of a single spoke of the frame 6355.

[0384] Referring first to FIGS. 64A - C, the frame 6355 includes a distal frame portion 6358 that supports the closure plug 6302 when fully assembled, and a proximal frame portion 6359 that supports the outer sheet 6360. Generally, each of the distal frame portion 6358 and the proximal frame portion 6359 includes a set of circumferentially distributed petal - like portions configured to fold and expand in a similar manner when the implant 6300 is folded and expanded during delivery and implantation.

[0385] The present disclosure contemplates manufacturing and assembling the frame 6355 in various ways, but in at least certain embodiments, the frame 6355 is formed as a single piece by precision cutting a tubular substrate of a material suitable for use in a medical implant. For example, in at least certain embodiments, the frame 6355 is cut from a high cycle fatigue (HCF) nitinol tube. The frame cut from the tube can then be heated and bent into the final shape shown and described in the following sections using a shape setting process that conforms to the substrate. Also, subsequent frame processing, such as electropolishing, passivation, deburring, cleaning, etc., can be applied to achieve a finished frame.

[0386] As most clearly shown in FIG. 64B, the distal frame portion 6358 can include inner petal-shaped portions that extend radially and are circumferentially distributed, such as inner petal-shaped portion 6380A and inner petal-shaped portion 6380B. The inner arcuate petal-shaped portions can be oval, diamond-shaped, or otherwise a similar elongated shape (e.g., generally diamond-shaped but with rounded vertices and / or curved sides). Each inner petal-shaped portion can be defined by its respective major axis and minor axis. For example, as shown in FIG. 64J, the inner petal-shaped portion 6380A has a major axis 6381A that extends in the radial / longitudinal direction and a minor axis 6382A that extends substantially circumferentially. In certain embodiments, adjacent inner petal-shaped portions can be joined at or near their vertices along the minor axis. For example, as shown in FIG. 64J, the inner petal-shaped portion 6380A and the inner petal-shaped portion 6380B are joined at a junction 6384 that is disposed distally from the minor axis vertices of the inner petal-shaped portion 6380A and the inner petal-shaped portion 6380B.

[0387] Referring to FIG. 64B, the proximal frame portion 6359 may similarly include an outer petal-shaped portion that may be oval, diamond-shaped, or have another elongated shape. Each such outer petal-shaped portion may be defined by its respective major axis and minor axis. For example, as shown in FIG. 64K, the outer petal-shaped portion 6385A may have a major axis 6386A that extends substantially longitudinally and a minor axis 6387A that extends circumferentially. In certain embodiments, adjacent outer petal-shaped portions of the proximal frame portion 6359 may be joined at or near the apex (i.e., the common apex of the outer petal-shaped portions) along the minor axis. For example, the outer petal-shaped portion 6385A and the outer petal-shaped portion 6385B are joined at a joint 6389 disposed at the corresponding common apex of the outer petal-shaped portion 6385A and the outer petal-shaped portion 6385B.

[0388] Returning to FIG. 64B, the frame 6355 generally includes members, struts, spokes, or similar elongated members. When the frame 6355 is in the folded state, the spokes extend substantially longitudinally; when the frame 6355 expands, the spokes / struts extend radially outward and proximally. As shown in FIG. 64B, the spokes / struts extend from each arcuate petal-shaped portion of the distal frame portion 6358, and more specifically, from the proximal apex of each arcuate petal-shaped portion. For example, FIGS. 64B and 64J show a spoke 6395A extending from the apex 6396A of the inner petal-shaped portion 6380A and a spoke 6395B extending from the apex 6396B of the inner petal-shaped portion 6380B, respectively.

[0389] Referring again to FIG. 64B, each spoke extends from the corresponding inner petal-shaped portion of the distal frame portion 6358 to each joint between the outer arcuate petal-shaped portions of the proximal frame portion 6359. For example, FIG. 64M shows a spoke 6395C that terminates at the joint 6389 between the outer petal-shaped portion 6385A and the outer petal-shaped portion 6385B.

[0390] Each spoke may further extend to form an anchor member (e.g., a spike, tip, or hook) disposed between adjacent outer petal-like portions. For example, FIGS. 64B and 64M each include an anchor member 6399 disposed between an outer petal-like portion 6385A and an outer petal-like portion 6385B and extending from a junction 6389. As shown, the anchor members are included between each pair of adjacent outer petal-like portions; however, the present disclosure contemplates that more or fewer anchor members may be included and that the distribution of anchor members around the frame 6355 may vary. For example, in addition to the anchor members disposed between adjacent outer petal-like portions, additional anchor members may extend from the distal apexes of one or more outer petal-like portions. As another non-limiting alternative, the anchor members may extend from every other or every second junction between adjacent outer petal-like portions.

[0391] Figures 64D and 64E are diagrams of frame 6355 showing specific mechanisms and elements of interest, which are shown in detail in subsequent Figures 64F - 64I. More specifically, Figure 64D is a side view of frame 6355 oriented such that the spoke / anchor members face out of the drawing. In contrast, Figure 64E is an angled side view of frame 6355 oriented such that the outer petal-like portion faces out of the drawing (i.e., rotated 90° with respect to the view shown in Figure 64D). As shown in Figure 64D, Figure 64F is a side view of a portion of frame 6355, specifically, a detailed view of spoke portion 6400 extending between generally the junction between the inner petal-like portion of frame 6355 and the adjacent outer petal-like portion. For example, spoke portion 6400 may correspond to portions of spokes 6395A and 6395B that extend between the inner petal-like portion of frame 6355 and the corresponding junction of the outer petal-like portion. The specific curvature of spoke portion 6400 will be described in further detail below with respect to Figures 64N - P. However, as shown in Figure 64F, spoke portion 6400 generally has a convex curvature in the distal direction. The specific dimensions of spoke portion 6400 can vary, but in at least some embodiments, spoke portion 6400 may have a thickness 6402 of about 0.2 mm to about 0.4 mm. For example, in one specific embodiment, thickness 6402 is about 0.32 mm and may have a tolerance of ±0.04 mm. In embodiments where frame 6355 is formed by cutting it out from a tubular substrate, thickness 6402 may correspond to the thickness of the tubular substrate.

[0392] As further shown in FIG. 64D, FIG. 64G is a side view of the anchor member 6404 of the frame 6355. For example, the anchor member 6404 may correspond to the anchor member 6399 of the frame 6355 or other anchor members distributed around the frame 6355. As described above, the anchor members of the implant according to the present disclosure are generally configured to engage the tissue surrounding the valve annulus to facilitate fixation of the implant to the valve annulus during implantation. The specific size, shape, angle and similar features of the anchor member 6404 can vary based on the application; FIG. 64G shows a non-limiting exemplary structure of the anchor member 6404 that demonstrated favorable results in testing. As shown, the anchor member 6404 extends from a junction 6406 generally located between adjacent outer petal-like portions as described above. For example, the junction 6389 of the frame 6355 is shown in FIG. 64B as being located between the outer petal-like portion 6385A and the outer petal-like portion 6385B. As shown, the anchor member 6404 can be integral with the junction 6406 and can be formed by bending or curving the anchor member 6404 in the distal direction.

[0393] The performance characteristics of the anchor member 6404 can be varied and controlled by changing the dimensional shape of the anchor member 6404 and its geometric relationship (e.g., angle) to other parts of 6355. For example, FIG. 64G shows the depth 6408 or linear distance of the anchor member 6404, which generally corresponds to the maximum linear distance between the tip 6410 of the anchor member 6404 and the outer surface of the junction 6406 (e.g., the junction 6389 between the outer petal-like portion 6385A and the outer petal-like portion 6385B) between adjacent outer petal-like portions. The depth 6408 can vary and in at least some embodiments, the depth 6408 can be from about 1.0 mm to 3.5 mm. For example, in one specific embodiment, the depth 6408 is about 2.2 mm and can have a tolerance of ±0.4 mm.

[0394] The performance characteristics of the anchor member 6404 can also be varied and controlled by changing the thickness 6412 of the anchor member 6404. The thickness 6412 can be various, but in at least some embodiments, the thickness 6412 can be from about 0.2 mm to about 0.4 mm. For example, the thickness 6412 can be about 0.32 mm with a tolerance of ±0.04 mm. In embodiments where the frame 6355 is formed by cutting out the frame 6355 from a tubular substrate, the thickness 6412 can correspond to the thickness of the tubular substrate.

[0395] As shown in FIG. 64E, FIGS. 64H and 64I are detailed views of respective outer petal-shaped portions, specifically, detailed views of the proximal ranges of the outer petal-shaped portions. More specifically, FIG. 64H shows the outer petal-shaped portion 6414, specifically, a detailed front view of the proximal chevron 6416 of the outer petal-shaped portion 6414. In contrast, FIG. 64I shows the outer petal-shaped portion 6424, specifically, a detailed side view of the proximal chevron 6426 of the outer petal-shaped portion 6424.

[0396] First, referring to FIG. 64H, a proximal corrugation 6416 is formed at the junction of two petal-shaped portions, namely petal-shaped portion 6420A and petal-shaped portion 6420B. As described above, in certain embodiments of the present disclosure, the frame 6355 is laser cut from a tubular substrate such that certain dimensions can be controlled or otherwise determined by the wall thickness of the tubular substrate. In contrast, when the frame 6355 is cut out from a tubular substrate, the widths of the petal-shaped portion 6420A and the petal-shaped portion 6420B generally correspond to the circumference of the tubular substrate and, as a result, are controlled and determined by the cuts made to the tubular substrate. In other words, the widths of the petal-shaped portion 6420A and the petal-shaped portion 6420B can be varied and controlled and are not necessarily limited to the specific dimensions of the tubular substrate from which the frame 6355 is cut out. For example, FIG. 64H shows the widths 6422 of the petal-shaped portion 6420A and the petal-shaped portion 6420B, respectively. The width 6422 can be various, but at least in certain embodiments, the width 6422 can be from about 0.2 mm to about 0.4 mm. For example, in one specific embodiment, the width 6422 is 0.32 mm and can have a tolerance of ±0.04 mm.

[0397] Next, referring to FIG. 64I, a proximal corrugation 6426 of the outer petal-shaped portion 6424 is formed at the junction of two petal-shaped portions, namely petal-shaped portion 6428A and petal-shaped portion 6428B, and each petal-shaped portion generally has a thickness 6430. In certain embodiments, the thickness 6430 can be controlled by or otherwise correspond to the wall thickness of the tubular substrate from which the frame 6355 is cut out. The thickness 6430 can be various, but at least in certain embodiments, the thickness 6430 can be from about 0.2 mm to about 0.4 mm. For example, the thickness 6412 is about 0.32 mm and can have a tolerance of ±0.04 mm.

[0398] Similar to the previous frames described herein, frame 6355 can be formed from a variety of superelastic materials and / or shape memory materials, such as nickel-titanium alloys (e.g., nitinol), and these materials may be laser cut from tubing or in the form of drawn wire. The forms defined within the shape memory material can be defined therein by various cutting methods known in the art, such as laser, water jet, electrical discharge machining (EDM), stamping, etching, milling, etc.

[0399] Frame 6355 is shown as including twelve outer arcuate petal-shaped portions and twelve inner arcuate petal-shaped portions each, but in other embodiments, different numbers of inner and / or outer arcuate petal-shaped portions may be included. For example, in certain exemplary embodiments, frame 6355 may include 10 to 14, 8 to 16, or 6 to 18 inner and outer arcuate petal-shaped portions. In other embodiments, the number of inner arcuate petal-shaped portions may differ from the number of outer arcuate petal-shaped portions. Moreover, not all of the inner arcuate petal-shaped portions need be coupled to the corresponding spokes of frame 6355. For example, a spoke may extend from only every other inner arcuate petal-shaped portion.

[0400] As shown in the previous figure, each inner arcuate petal-shaped portion is uniform, similar to each outer arcuate petal-shaped portion. In other embodiments, the inner and outer arcuate petal-shaped portions may differ in any direction. For example, the inner arcuate petal-shaped portions may alternately include arcuate petal-shaped portions having a first major axis dimension and arcuate petal-shaped portions having a second major axis dimension different from the first major axis dimension.

[0401] Further exemplary dimensions and mechanisms of the frame 6355 are shown in FIGS. 64L-64N. Specifically, FIGS. 64L and 64M are further side views of the frame 6355, and FIG. 64M is a view obtained by rotating FIG. 64L about 90° around the vertical axis 6370 of the frame 6355. FIG. 63N is a detailed view of an exemplary spoke 6432. The following description explains various dimensions and shapes of the frame 6355 and its elements. Similar to other aspects of the present disclosure, specific dimensions and values should be considered non-limiting and are included merely as exemplary values found to be suitable for use in a particular valve repair procedure. In particular, the dimensions described below can be changed and adjusted to account for differences in a patient's physiology.

[0402] Referring first to FIG. 64L, the frame 6355 is shown with three dimensions generally noted with respect to the spokes and inner petal-like portion of the frame 6355. First, the overall height of the frame 6355 is shown as H1. Generally, H1 corresponds to the distance between the distal and proximal ranges of the frame 6355 along the central vertical axis 6370. In certain embodiments, non-limitingly, H1 can be from about 15 mm to about 20 mm, and in one specific example is about 17.5 mm, with a tolerance of ±0.5 mm.

[0403] FIG. 64L further includes a dimension H2 corresponding to the vertical height of the outer petal-like portion measured from the proximal range of the frame 6355. In certain embodiments, non-limitingly, H2 can be from about 11 mm to about 16 mm, and in one specific example is about 14 mm, with a tolerance of ±0.5 mm.

[0404] Finally, FIG. 64L includes a dimension R1 corresponding to the radius of curvature of the outer petal-like portion. In certain embodiments, non-limitingly, R1 can be from about 15 mm to about 35 mm, and in one specific example can be about 25 mm.

[0405] Turning to FIG. 64M, frame 6355 is shown with two dimensions entered. First, the height of the anchor member of frame 6355 relative to the distal range of frame 6355 is entered as H3. In certain embodiments, non - limitingly, H3 can be from about 9 mm to about 15 mm and in one specific example can be about 12 mm.

[0406] FIG. 64M further includes the height of the inner petal - like portion relative to the distal range of frame 6355, entered as H4. In certain embodiments, non - limitingly, H4 can be from about 1.5 mm to about 3.5 mm and in one specific example can be about 2.4 mm.

[0407] FIG. 64N is a cross - sectional view of frame 6355 highlighting member 6432 of frame 6355 with the remaining elements of frame 6355 removed for clarity. As shown, member 6432 includes an anchor member 6434, a junction 6436 (corresponding to the junction between the outer petal - like portions of frame 6355), a spoke 6438, and an inner petal - like portion 6440. FIG. 64N includes the entry of two curvatures and five height dimensions. Similar to the previous figures, the various dimensions are intended to be merely illustrative and can be readily adapted and changed, for example, to accommodate differences in a patient's physiology.

[0408] Dimension H5 corresponds to the height of anchor member 6434 and junction 6436. In certain embodiments, non - limitingly, H5 can be from about 1 mm to about 4 mm and in one specific example can be about 2 mm. Other exemplary dimensions and features of anchor member 6434 are provided above in connection with FIG. 64G.

[0409] Dimension H6 corresponds to the height of the proximally recessed portion 6439 of the spoke 6438. The proximally recessed portion 6439 generally extends between the joint 6436 of the spoke 6438 and the distally recessed portion 6441. As shown, the proximally recessed portion 6439 is generally defined in FIG. 64N by the height H6 and the radius of curvature R2, and H6 corresponds to the distance between the joint 6436 and the distal extent of the proximally recessed portion 6439. In certain embodiments, and without limitation, H6 can be from about 2 mm to about 4 mm, and in one specific example can be about 3 mm. Similarly, in certain embodiments, and without limitation, R2 can be from about 4 mm to about 10 mm, and in one specific example can be about 7 mm.

[0410] Dimension H7 corresponds to the difference between the distal extent of the proximally recessed portion 6439 and the proximal extent of the distally recessed portion 6441. In certain embodiments, and without limitation, H7 can be from about 0.25 mm to about 3 mm, and in one specific example can be about 1.25 mm.

[0411] Dimension H8 corresponds to the height of the distally recessed portion 6441. The distally recessed portion 6441 generally extends between the proximally recessed portion 6439 and the inner petal-shaped portion 6440. As shown, the distally recessed portion 6441 is generally defined in FIG. 64N by the height H8 and the radius of curvature R3, and H8 corresponds to the distance between the proximal extent of the distally recessed portion 6441 and the start of the inner petal-shaped portion 6440. In certain embodiments, and without limitation, H8 can be from about 2.5 mm to about 8.5 mm, and in one specific example can be about 5.5 mm. Similarly, in certain embodiments, and without limitation, R3 can be from about 4 mm to about 10 mm, and in one specific example can be about 7 mm.

[0412] Finally, dimension H9 corresponds to the height of the inner petal-shaped portion 6440 and is generally defined as the distance between the end of the proximally recessed portion 6439 and the distal extent of the frame 6355. In certain embodiments, non-limitingly, H9 can be from about 1.5 mm to about 4 mm and, in one particular example, can be about 2.5 mm. Similarly, in certain embodiments, non-limitingly, R4 can be from about 30 mm to about 50 mm and, in one example, can be about 40 mm.

[0413] XVIII. Laminated closure plug for valve repair implant As described above with respect to FIGS. 64A and 63B, the implant 6300 includes a closure plug 6302. In contrast to the bulbous and sheet-type closure plugs of other embodiments provided herein, the closure plug 6302 has a multi-layer laminated structure and a generally cap-like shape. In particular, such a closure plug forms a relatively large distal surface of the implant 6300 (against which the natural valve tip can abut to form a seal) while resulting in a generally lower profile and smaller overall height of the implant 6300, providing a substantial reduction in backflow and other valve-related problems.

[0414] FIGS. 65A and 65B are detailed views of the closure plug 6302 of the implant 6300. More specifically, FIG. 65A is a distal view of the closure plug 6302 and FIG. 65B is an isometric view of the closure plug 6302. FIG. 65C is a distal isometric view of the frame 6355 of the implant 6300 and the closure plug 6302 and is provided to explain the closure plug 6302 in the broader background information of the implant 6300 and the frame 6355.

[0415] Referring to FIGS. 65A and 65B, the closure plug 6302 is generally formed directly on the distal frame portion 6358 of the frame 6355. More specifically, the closure plug 6302 is formed on the inner petal-shaped portion of the distal frame portion 6358. Although the present disclosure contemplates that the closure plug 6302 can be formed in various ways on the distal frame portion 6358, in at least one embodiment, the closure plug 6302 is formed on the distal frame portion 6358 by applying a first sheet 6502 of a substantially impermeable material on the distal surface 6504 of the distal frame portion 6358 (shown most clearly in FIG. 65D). A second sheet 6506 of a porous or semi-porous material is then placed on the proximal surface 6508 of the distal frame portion 6358 such that the second sheet 6506 substantially overlaps the first sheet 6502 and the inner petal-shaped portion of the distal frame portion 6358 is positioned between the first sheet 6502 and the second sheet 6506. An epoxy, adhesive, or similar binder is then applied to the proximal surface 6508 of the distal frame portion 6358 such that it penetrates the second sheet 6506 and, if cured, adheres the second sheet 6506 to the first sheet 6502 and the inner petal-shaped portion of the distal frame portion 6358.

[0416] Figure 65D is an exploded view of the closure plug 6302 and the frame 6355. As shown, each of the first sheet 6502 and the second sheet 6506 is cut and formed to be received in and adhered to the distal frame portion 6358 of the frame 6355. The specific materials and processes for forming the closure plug 6302 can vary in embodiments of the present disclosure; in at least one exemplary embodiment, the first sheet 6502 is formed from a biocompatible, low porosity engineering polymer. In certain embodiments, for example, the first sheet 6502 can be formed from expanded polytetrafluoroethylene (ePTFE) or a similar polymer. In contrast, the second sheet 6506 can be formed from a substantially more porous and flexible material. As a non-limiting example, in certain embodiments, the second sheet 6506 is formed from a porous and biocompatible fabric, such as a woven polyethylene terephthalate (PET) material. For example, in some embodiments, the material of the second sheet 6506 can be the same or similar to the material used for the outer sheet 6360 (shown in FIG. 63A) of the implant 6300.

[0417] The present disclosure contemplates that various materials may be used to adhere the first sheet 6502 and the second sheet 6506 to each other and to the distal frame portion 6358. In one exemplary embodiment, the adhesion is achieved using a combination of a siloxane-segmented polyurethane and a polymer precursor, such as tetrahydrofuran (THF). During assembly, the polyurethane is dissolved in THF, and the resulting mixture is applied to the second sheet 6506 and the proximal surface 6508 of the distal frame portion 6358. Thereafter, the first sheet 6502 and the second sheet 6506 are overlaid on the distal frame portion 6358. The relatively high viscosity of the polyurethane / THF mixture allows for relatively easy penetration of the second sheet 6506, encapsulation of the fibers of the second sheet 6506, and influx into the volume between the first sheet 6502, which includes the distal frame portion 6358, and the second sheet 6506. After subsequent curing, the polyurethane / THF mixture provides a strong, firm, and substantially impermeable adhesion between the first sheet 6502 and the second sheet 6506. In particular, the polyurethane and certain polyurethane-based compounds can cure / solidify without the application of additional heat that might deform or distort the frame 6355.

[0418] Figures 65E and 65F are distal and side views of the frame 6355 including the closure plug 6302 after the closure plug 6302 is coupled to the frame 6355. As shown in FIG. 65 and described above with respect to FIG. 64D, the closure plug 6302 may generally have a diameter D1. D1 may vary for the uses of the present disclosure, but in certain embodiments, D1 may be from about 16 mm to about 28 mm. In other embodiments, D1 may be from about 20 mm to about 22 mm. In one particular embodiment, D1 is about 21.4 mm with a tolerance of ±0.5 mm.

[0419] Referring to FIG. 65F, the closure plug 6302 can be configured to have a predetermined height, as indicated by dimension H10. As shown, H10 corresponds to the distance between the distal end of the closure plug 6302 (generally corresponding to the distal extent of the implant 6300) and the proximal end of the closure plug 6302 (e.g., the proximal radially outer edge 6363 shown in FIGS. 63A and 64B). H10 can vary; in certain embodiments, H10 can be from about 3.0 mm to about 5 mm. For example, in one embodiment, H10 is about 4 mm, with a tolerance of ±0.5 mm.

[0420] FIGS. 66A and 66B show a closure plug 6602 that can be used in the implant 6300 and other implants according to the present disclosure as an alternative or variation to the closure plug 6302. Specifically, FIG. 68A is a distal view of an alternative closure plug 6602 coupled to the frame 6355 of the implant 6300, and FIG. 68B is a proximal view of the closure plug 6602 assembled in the same manner as the implant 6300.

[0421] As described above and shown in FIGS. 65A - 65F, the closure plug 6302 has a concave proximal surface. In contrast, as most clearly shown in FIG. 66B, the closure plug 6602 is configured to have a convex proximal surface 6604. In particular, the convex proximal surface 6604 provides benefits to the blood flow dynamics throughout the implant 6300 by more effectively directing flow around the closure plug 6602.

[0422] As shown in FIGS. 66A and 66B, the closure plug 6602 can have a multi-part structure including a distal portion 6606 coupled to a proximal portion 6608. The distal portion 6606 is recessed in the distal direction and can be substantially similar to the closure plug 6302. In contrast, the proximal portion 6608 is recessed in the distal direction and is coupled to the distal portion 6606 such that the closure plug 6602 has an overall pillow shape. As shown in FIGS. 66A and 66B, the proximal portion 6608 is coupled to the distal portion 6606 by suturing the distal portion 6606 to the proximal portion 6608; the present disclosure contemplates that other methods such as adhesives, epoxies, welding / adhesion, etc. can be used to couple the proximal portion 6608 to the distal portion 6606.

[0423] The proximal portion 6608 can be constructed in various ways; in the embodiment shown in FIG. 68B, the proximal portion 6608 includes a sheet 6610 and an internal frame 6612. The internal frame 6612 is shown as having a star-shaped structure including radially extending arms such as arm 6614. Each arm is coupled to the sheet 6610, for example by suture threads, thereby attaching the sheet 6610 to the internal frame 6612 such that the internal frame 6612 gives the sheet 6610 a curved shape. In at least certain embodiments, the internal frame 6612 can be formed using techniques similar to those used to form the frame 6355. For example, the internal frame 6612 can be cut out (e.g., laser cut) from a tubular substrate (e.g., a nitinol tube), processed, and formed into the star shape shown in FIG. 68B.

[0424] Sheet 6610 may also be formed from a variety of materials; in certain embodiments, sheet 6610 may be formed from a porous material, such as woven PET used for the second sheet 6506 of closure plug 6302 and the outer sheet 6360 of implant 6300. In particular, using a porous material allows air to be expelled from the internal volume 6616 of closure plug 6602 in preparation for delivery and implantation. After implantation, the porosity of sheet 6610 may allow some blood to flow into internal volume 6616; however, sheet 6610 substantially inhibits blood from flowing out of internal volume 6616, such that the blood that enters internal volume 6616 ultimately fills internal volume 6616 and clots therein to form a thrombus, and that thrombus effectively creates closure plug 6602 having a substantially solid body that redirects blood flow around closure plug 6602.

[0425] In certain alternative embodiments, internal volume 6616 may be filled with an epoxy, a coagulating gel, a solid insert, or similar material or object that substantially fills internal volume 6616 prior to delivery and implantation. In other embodiments, internal volume 6616 may contain a fluid, such as a hydromorphic polymer, hydrogel, or similar substance that expands upon exposure to a fluid, such as blood, to expand and fill internal volume 6616 after implantation. In yet other alternative embodiments, closure plug 6602 may have a substantially solid structure. For example, closure plug 6602 may be in the form of a substantially solid biocompatible body having an overall shape similar to closure plug 6602 shown in FIGS. 66A and 66B that can be readily coupled to distal frame portion 6358 to form closure plug 6602.

[0426] XIX. Outer Sheet Construction and Assembly As previously described with respect to FIG. 63A, the implant 6300 includes an outer sheet 6360 that extends circumferentially around a proximal portion of the frame 6355. The outer sheet 6360 provides various functions, including protecting the tissue around the valve annulus from the frame 6355, facilitating alignment of the implant 6300 within the valve annulus, and securing the implant 6300 in its implanted position (e.g., through ingrowth of tissue into the outer sheet 6360). Further details regarding the construction and assembly of the outer sheet 6360 are provided below with reference to FIGS. 67A - 67D.

[0427] FIG. 67A is a side view of the distal face of the implant 6300. As shown, the implant 6300 includes a closure plug 6302 coupled to the frame 6355 at the distal end 6340. The implant 6300 further includes an outer sheet 6360 that extends circumferentially around a proximal portion of the frame 6355 and is coupled to and supported by the frame 6355. The shape of the outer sheet 6360 can vary, but in the embodiment shown in FIG. 67A, the distal radially inner edge 6365 of the outer sheet 6360 is circular and the proximal radially outer edge 6366 has a sinusoidal / repeating shape.

[0428] FIG. 67B is a proximal side view of a portion of the frame 6355 and the outer sheet 6360 of the implant 6300, further showing the assembly of the outer sheet 6360 to the frame 6355. The detailed view shown in FIG. 67B shows the attachment of the outer sheet 6360 to the first outer petal - like portion 6702A and the second outer petal - like portion 6702B of the frame 6355, respectively.

[0429] The outer sheet 6360 is shown as being coupled to the frame 6355 using both suture loops and hemming. For example, the first outer petal-shaped portion 6702A includes a frame portion 6704A and a frame portion 6704B, and the frame portion 6704B extends between the distal apex 6706 of the first outer petal-shaped portion 6702A and the joint 6708 formed between the first outer petal-shaped portion 6702A and the second outer petal-shaped portion 6702B. Along the frame portion 6704B, three suture loops 6709A - 6709C are disposed to couple the outer sheet 6360 to the frame 6355. Additional suture loops are distributed around the joint 6708 to further strengthen the connection of the joint 6708 to the frame 6355. To further strengthen the connection between the outer sheet 6360 and the frame 6355 around the joint 6708, an additional suture 6709D is disposed proximal to the joint 6708.

[0430] The outer sheet 6360 is also coupled to the frame 6355 by hems extending along the proximal and distal edges of the frame 6355 respectively. For example, the first hem 6710 extends along the radially inner edge 6365 and encloses the distal apex of the outer petal-shaped portion (e.g., the distal apex 6706 of the first outer petal-shaped portion 6702A). The second hem 6712 extends along the proximal radially outer edge 6366 and conforms to the variable shape of the proximal radially outer edge 6366.

[0431] As shown, the second hem 6712 is discontinuous and consists of separate hem portions corresponding to the proximal halves of each outer petal-shaped portion. For example, the first outer petal-shaped portion 6702A includes a first petal-shaped segment 6714A and a second petal-shaped segment 6714B that extend proximally and meet at the proximal apex 6716. The outer sheet 6360 includes a first hem segment 6718A and a second hem segment 6718B corresponding to and including the first petal-shaped segment 6714A and the second petal-shaped segment 6714B respectively, with the first hem segment 6718A folded over the second hem segment 6718B.

[0432] The second hem 6712 is shown as being discontinuous between the petal-like portions, for example at the junction 6708. Despite this discontinuity, the suture used to form the separate portions of the second hem 6712 may be continuous and may be routed so as to cross the junction between the petal-like portions. For example, FIG. 67B shows a suture segment 6722 crossing the junction 6708 that is continuous between a first hem segment 6718A and a second hem segment 6718B.

[0433] FIGS. 67C and 67D show the proximal apex 6716 and the distal apex 6706 in greater detail, respectively. As shown in each figure, a suture wrap may be formed at one or both of the proximal apex 6716 and the distal apex 6706. For example, a proximal suture wrap 6724 is shown extending around the proximal apex 6716 in FIG. 67C, and a distal suture wrap 6726 is shown extending around the distal apex 6706 in FIGS. 67C and 67D, respectively. Incorporating suture wraps as shown provides several notable advantages. As a first example, each of the suture wraps provides a secure and reinforced attachment of the outer sheet 6360 to the frame 6355. The suture wraps also provide additional stuffing around the apexes of the outer petal-like portions of the frame 6355. Finally, the suture wraps may fill the gaps between the hem segments. For example, the proximal suture wrap 6724 is disposed between a first hem segment 6718A and a second hem segment 6718B and may fill / cover a gap that may exist between the two segments despite the first hem segment 6718A being folded back over the second hem segment 6718B.

[0434] FIG. 68 shows an example of the outer sheet 6360 before attachment to the frame 6355. As shown, the outer sheet 6360 is a single piece of woven PET material cut (e.g., laser cut) to conform to the frame 6355 and include various tabs and the like for forming any hems necessary to attach the outer sheet 6360 to the frame 6355. FIG. 68 further shows a first fold line 6728 corresponding to the first hem 6710 and a series of second fold lines 6730 corresponding to the second hem 6712.

[0435] In one exemplary assembly process, after cutting the outer sheet 6360, the outer sheet 6360 is wrapped around the frame 6355 and stitched / sewn to the frame 6355 as shown in the previous figures. Such stitching / sewing generally includes forming each of the first hem 6710 and the second hem 6712 and forming any additional stitching loops (e.g., stitching loops 6709A - 6709). To facilitate wrapping the outer sheet 6360 around the frame 6355, the outer sheet 6360 includes an open side 6732 that closes when the outer sheet 6360 is wrapped around the frame 6355. To facilitate this process, the outer sheet 6360 may include additional tabs, such as tab 6734, to maintain the outer sheet 6360 in a closed configuration while it is attached to the frame 6355. After initially wrapping the outer sheet 6360 around the frame 6355, the tab 6734 can be folded inward (e.g., along the fold line 6736) and held in place by stitching / sewing. Doing so helps maintain the approximate shape of the outer sheet 6360 and facilitates folding and forming the various hems and stitching loops necessary to securely attach the outer sheet 6360 to the frame 6355.

[0436] The foregoing description provides an example of the construction and assembly of the outer sheet 6360. In particular, this example involved cutting the outer sheet 6360 from a sheet of a suitable material (e.g., woven PET) and attaching the outer sheet 6360 to the frame 6355 using a combination of hems and suture loops. In embodiments that rely on suturing, the attachment of the outer sheet 6360 to the frame 6355 can be achieved using a monofilament suture, a multifilament suture, or a combination of a monofilament suture and a multifilament suture. Also, the present disclosure contemplates that the outer sheet 6360 can be attached to the frame 6355 using sutures, adhesives, welding, or any combination thereof. For example, in certain embodiments, either thermal welding or ultrasonic welding can be used to close the various hems shown in the previous figures. As another example, polyurethane, silicone, or similarly suitable and biocompatible adhesives, epoxies, binders, etc. may be used. The present disclosure also contemplates that the outer sheet 6360 can be attached to the frame 6355 using multiple fixation techniques. For example, an adhesive may initially be used to effect an initial or partial attachment of the outer sheet 6360 to itself, but it may be reinforced or strengthened by suturing, welding, etc.

[0437] XX. Implants including eyelets for suture line retrieval The implant delivery system of the present disclosure generally relies on two mechanisms for controlling the expansion and folding of the implant during delivery. First, during delivery, the implant according to the present disclosure can be positioned on the control arm assembly of the delivery tool. The control arm assembly includes control arms configured to radially expand and contract in response to the operation of a corresponding control mechanism of the handle assembly of the delivery tool. The control arms are coupled to the frame of the implant such that when the physician radially expands the control arms outwardly, the implant expands. Similarly, when the physician retracts the control arms radially inwardly, the implant is pulled inwardly and folded.

[0438] In addition to the control arm, the delivery system according to the present disclosure may include one or more fastening lines. The one or more fastening lines are passed through the delivery tool and extended circumferentially around the frame of the implant. In embodiments including a single fastening line, the fastening line can be passed from the handle assembly through the catheter assembly of the delivery system (e.g., through a fastening line tube extending through the catheter assembly) around the entire circumference of the implant and then passed back through the catheter assembly in the opposite direction and returned to the handle assembly.

[0439] In contrast, in embodiments including a plurality of fastening lines, each fastening line can be similarly passed through the delivery catheter assembly but can only be looped around a portion of the perimeter of the implant. For example, in an embodiment including two fastening lines, each fastening line extends around approximately half of the perimeter of the implant and can meet at the holding position. Each fastening line can terminate with a loop or a similar mechanism through which a holding pin or cable can be passed to hold the fastening line during delivery and implantation.

[0440] During delivery and implantation, the one or more fastening lines provide various functions and benefits. Generally, the one or more fastening lines hold the implant on the control arm; by maintaining the tension of the one or more fastening lines during expansion and folding of the implant, the fastening lines can substantially improve the uniformity of expansion and folding by evenly distributing the expansion / folding force around the implant. In this regard, maintaining the tension of the one or more fastening lines can also improve the responsiveness of implant expansion and folding control by reducing or eliminating slack that may have to be eliminated before an operation of the control mechanism by the physician causes the corresponding movement of the implant.

[0441] Regardless of whether there is one or multiple tightening lines included, after the delivery and implantation of the implant, the tightening line must be detached from the implant to enable the release of the implant and its subsequent removal from the delivery system. In an embodiment including a single tightening line that forms a large loop through the delivery system, the tightening line can be cut at a proximal position and then pulled through the catheter assembly. In an embodiment including multiple tightening lines held by a retention cable in the implant, the retention cable can be retracted to release the tightening lines and then pulled through the delivery catheter. An exemplary handle assembly for this process and for ordering the retraction of the retention cable and the tightening lines will be described in more detail below with respect to FIGS. 83A-86D.

[0442] Smooth and reliable retraction of the tightening line is a very important part of the implantation process. For example, if the tightening line binds, catches, or is otherwise restricted when being retracted, the resulting pull on the implant may move the implant within the valve annulus or, in extreme cases, partially or completely displace it from its implantation position.

[0443] To avoid or reduce the likelihood of such situations, embodiments of the present disclosure include various mechanisms for more reliable and consistent handling of the tightening line, particularly for consistent retraction of the tightening line when releasing the implant from the delivery system. For example, in the embodiment shown in FIG. 59, a handling ring (e.g., ring 3646) is coupled to the control arm of the delivery device 3600, and the tightening line 3614 is routed through each handling ring and a corresponding ring (e.g., ring 3804) coupled to the frame of the implant 3800.

[0444] As another alternative embodiment to be described in further detail in this section, an improvement in the clamping line routing is provided by a series of eyelets coupled to the implant frame. More specifically, specially designed eyelets are coupled to the implant frame so as to be circumferentially distributed around the radially inner surface of the implant. In one specific embodiment, the junction between adjacent outer petal-like portions of the implant frame includes a slot into which separately manufactured eyelets are inserted. In contrast to the ring included in the embodiment shown in FIG. 59, the eyelets are firmly held using one or more coupling techniques to form a consistent and reliable path for one or more clamping lines around the implant. Further mechanisms, such as a smooth rounded lumen, bunch up or reduce the likelihood of catching when the clamping line is retracted through the eyelet, thereby improving the overall reliability and consistency when the clamping line can be retracted during release of the implant from the delivery device.

[0445] FIGS. 69A and 69B are, respectively, a partial proximal view and a detailed proximal view of an implant 6300. The implant 6300 has been described in detail in a previous section; the implant 6300 generally includes a frame 6355, which includes a series of circumferentially distributed spokes extending from a distal frame portion 6358 to a proximal frame portion 6359. The proximal frame portion 6359 includes a series of circumferentially distributed outer petal-like portions, such as outer petal-like portion 6385A and outer petal-like portion 6385B. Each pair of outer petal-like portions meets at a junction, such as junction 6384. Each junction further connects to one of the spokes extending from the distal frame portion 6358. For example, junction 6384 connects outer petal-like portion 6385A, outer petal-like portion 6385B, and spoke 6395A. Also, in at least certain embodiments, an anchor member, such as anchor member 6399, may extend from junction 6384.

[0446] In certain embodiments of the present disclosure, each joint of the frame 6355 may further include an eyelet for use when routing one or more tightening lines around the inner surface of the implant 6300. For example, FIG. 69B shows an eyelet 6802 disposed in and coupled to the joint 6384. Also, additional eyelets are shown as being coupled to adjacent joints. In certain embodiments, each joint of the frame 6355 may include respective eyelets such that the eyelets extend around the entire circumference of the implant 6300 and enable corresponding complete routing of one or more tightening lines around the implant 6300.

[0447] FIG. 70 is an isometric view of the eyelet 6802, and FIGS. 71A - C are, respectively, a plan view, a bottom view, and a cross-sectional view of the eyelet 6802. As shown, the eyelet 6802 generally includes a shank 6804 extending in a first direction and a body 6808 extending perpendicularly from the shank 6804. In certain embodiments, the shank 6804 defines a retention hole 6806 that can be used to couple the eyelet 6802 to the frame 6355 using a suture loop or similar coupling element. Similarly, the body 6808 defines a tightening line hole 6810 that generally is sized and formed to enable a tightening line to pass through the body 6808.

[0448] As shown in FIG. 70, undercuts may be created where the body 6808 abuts the shank 6804 on both sides of the body 6808. For example, FIG. 70 shows an undercut 6812A on a first side of the body 6808 and an undercut 6812B on the opposite side of the body 6808. As will be described in more detail below, the undercuts 6812A and 6812B facilitate flush contact between the shank 6804 and the proximal side of the joint 6384 when the eyelet 6802 is assembled with the frame 6355.

[0449] Figures 71A - 71C show further views of the eyelet 6802 including various dimensions. Similar to other aspects of the present disclosure, the specific dimensions of the eyelet 6802 can vary, and any ranges or dimensions specifically recited in this and other parts of the present disclosure are merely intended as examples reflecting certain favorable results during development and testing.

[0450] First, referring to FIG. 71A, dimension W1 corresponds to the width of the body 6808, dimension D5 corresponds to the diameter of the through - hole of the clamping - line hole 6810, H11 corresponds to the offset between the upper range of the shank 6804 and the starting end of the radius of the clamping - line hole 6810, and D6 corresponds to the diameter of the retaining hole 6806. In certain embodiments, W1 can be from about 0.9 mm to about 1.0 mm, and in one specific example is about 0.927 mm with a tolerance of ±0.02 mm. In certain embodiments, D5 can be from about 0.55 mm to about 0.6 mm, and in one specific example, together with the tolerance, is about 0.527 mm. In certain embodiments, H11 can be from about 0.55 mm to about 0.65 mm, and in one specific example is about 0.596 mm with a tolerance of ±0.02 mm. In certain embodiments, D6 can be from about 0.35 mm to about 0.4 mm, and in one specific example is about 0.38 mm.

[0451] FIG. 71B is a bottom view of the eyelet 6802 and includes dimension W2 corresponding to the width of the shank 6804 and dimension T1 corresponding to the thickness of the eyelet 6802. In certain embodiments, W2 can be from about 1.8 mm to about 2.0 mm, and in one specific example is about 1.875 mm with a tolerance of ±0.02 mm. In certain embodiments, T1 can be from about 0.3 mm to about 0.4 mm, and in one specific example is about 0.36 mm with a tolerance of ±0.02 mm.

[0452] Finally, FIG. 71C is a cross-sectional view of the body 6808 across the clamping line hole 6810 shown in FIG. 71A. As shown, in at least certain embodiments, the clamping line hole 6810 may have a rounded or otherwise machined side surface to eliminate any sharp edges that might catch or otherwise impede the drawing of the clamping line. The radius of the clamping line hole 6810 is shown as R5 in FIG. 71C. In certain embodiments, R5 can be from about 0.15 mm to about 0.20 mm and in one specific example is about 0.18 mm.

[0453] FIG. 72 is a detailed view of the joint 6384 with the eyelet 6802 removed. More specifically, FIG. 72 is a detailed view from a perspective orthogonal to the slot 7202 on the distal side of the frame 6355. As described above, the joint 6384 provides a connection location between the spoke 6395A, the outer petal-shaped portion 6385A, and the outer petal-shaped portion 6385B, and the anchor member 6399 can extend outwardly from the joint 6384.

[0454] Slot 7202 is defined by joint 6384, extends therethrough, and is formed to receive eyelet 6802. For example, in certain embodiments, slot 7202 is formed by laser cutting or other means in the same process as the remainder of frame 6355 (e.g., the process by which frame 6355 is laser cut from a tubular substrate such as a nitinol tube). Slot 7202 varies in size and shape depending on the scale of frame 6355, and more specifically, the size and shape of eyelet 6802. Nevertheless, in certain embodiments, slot 7202 may generally have a width W2 and a length L1, where W2 corresponds to a dimension extending perpendicular to spoke 6395A and L corresponds to a dimension extending parallel to spoke 6395A. The dimensions of W and L can vary, but in certain embodiments, W can be from about 0.3 mm to about 0.5 mm. For example, W2 can be about 0.405 mm with a tolerance of ±0.03 mm. Similarly, L1 can vary in different embodiments of the present disclosure; in certain embodiments, L1 can be from about 0.75 mm to about 1.5 mm. In one specific example, L1 is about 1.075 mm with a tolerance of ±0.03 mm.

[0455] FIG. 73A is a cross-sectional view of the joint 6384 where the inlet 6802 is installed. As shown, the inlet 6802 is inserted into the slot 7202, the shank 6804 of the inlet 6802 abuts against the distal surface 7302 of the joint 6384, the tightening line hole 6810 extends to the proximal side 7304 of the joint 6384, and the contact between the shank 6804 and the distal surface 7302 is configured to prevent further proximal movement by the inlet 6802. The inlet 6802 is shown as being coupled to the joint 6384 by a suture loop 7306 that extends around the joint 6384 and passes through the retention hole 6806 of the inlet 6802. In other embodiments, the inlet 6802 may be retained within the slot 7202 using alternative or additional means. For example, the inlet 6802 may be adhered to the joint 6384 using an adhesive or a welding process. As another alternative, the bodies 6808 of the slot 7202 and the inlet 6802 may be sized such that an interference fit is formed between the slot 7202 and the body 6808, which positively retains the inlet 6802 within the slot 7202. As further shown in FIG. 73A, when the implant 6300 is fully assembled, the outer sheet 6360 is generally disposed more distally than the shank 6804. Thus, the outer sheet 6360 may also be configured to abut against the shank 6804 and apply a proximal force thereto to facilitate retention of the inlet 6802 within the slot 7202.

[0456] FIG. 73B is similarly a cross-sectional view of the junction 6384 where the inlet 6802 is installed, but the implant 6300 is coupled to the control arm 7308 of the delivery tool, and the tightening line 7310 is passed through the tightening line hole 6810 of the inlet 6802. As shown, the control arm 7308 includes a hole or slot 7312 formed to receive the body 6808 of the inlet 6802. After insertion of the inlet body 6808 into the slot 7312, the tightening line 7310 is passed through the tightening line hole 6810, thereby holding the implant 6300 on the control arm 7308. This general assembly process is then repeated for each inlet of the implant 6300 and each corresponding control arm of the delivery device.

[0457] After placement of the implant 6300, release (e.g., by cutting, pulling, or retracting the retaining pin / cable) and retract the tightening line 7310. During retraction, the tightening line 7310 passes through the tightening line hole 6810. If the tightening line 7310 passes through the tightening line hole 6810, the control arm 7308 becomes separable from the inlet 6802, thereby enabling release of the implant 6300 from the delivery tool.

[0458] The present disclosure contemplates that the inlet 6802 can be formed and manufactured using various materials and processes. Still, in one specific embodiment, the inlet 6802 is formed from titanium that is precision machined, cleaned, and electropolished prior to assembly with the frame 6355.

[0459] XXI. Delivery Tool with an Internal Tube Having Modified Flexibility Figures 36-44 illustrate various mechanisms and components of a delivery device 3600, which is a non-limiting example of an implant delivery device according to the present disclosure. As described with respect to Figures 36-44, the delivery device 3600 includes a delivery catheter 3604, which is a main operable element of the delivery device 3600. The delivery device 3600 further includes various tubes and shafts within the delivery catheter 3604 for performing various functions of the delivery device 3600. For example, the tube 3626 provides a conduit through which the control arm shaft 3642 and the control arm assembly 3608 extend.

[0460] In addition to providing protection and support for the control arm shaft 3642 and the control arm assembly 3608, in at least some embodiments, the tube 3626 is also extendable and retractable relative to the delivery catheter 3604 to facilitate placement of the implant during the implantation process. Embodiments of the present disclosure that enable such extension and retraction and corresponding control mechanisms are shown in Figures 79A-79D and are further described below.

[0461] Generally, extension and retraction of the distal tube 3626 requires that the distal tube 3626 have sufficient axial strength and rigidity to efficiently and responsively transmit the longitudinal force applied at the handle assembly of the delivery system. However, when the delivery catheter 3604 is operable, the distal tube 3626 must also have sufficient flexibility to allow manipulation of the delivery catheter 3604 without imparting substantial resistance.

[0462] To address these issues, among other things, the present disclosure provides an inner tube for an implant delivery system that has sufficient rigidity to transmit the forces necessary for the extension and retraction of an implant supported at the distal end of a tube, and sufficient flexibility so as to not substantially affect the manipulation and control of a delivery catheter within which the tube is housed. As will be described in more detail below, these goals are achieved by forming a substantial length of the tube with a uniform and relatively high-rigidity structure. A particular distal portion of the tube, generally corresponding to the manipulable portion of the delivery catheter, further includes slits, cutouts, helical cuts or similar mechanisms that locally reduce the bending rigidity of the tube without substantially changing the axial strength and force transmission characteristics. In some embodiments, such rigidity-reducing mechanisms can be configured to reduce the rigidity of the tube with respect to bending along a particular plane or in a particular direction, such as a plane corresponding to the manipulation plane of the delivery catheter, while maintaining the rigidity with respect to bending in other directions.

[0463] FIG. 74 shows an exemplary delivery system 7400 for an implant 7402. The delivery system 7400 generally corresponds to the delivery device 3600 described above. As described with respect to the delivery device 3600, the delivery system 7400 includes a steerable catheter 7404 that includes a plurality of steerable portions. Other structures and steering devices of the steerable catheter 7404 are contemplated and are within the scope of the present disclosure, but the steerable catheter 7404 generally includes a distally steerable portion 7406 that is steerable along a first plane (e.g., plane 4506 shown in FIG. 45A. Bending along plane 4506 is further shown in FIGS. 45B and 45C), and a proximally steerable portion 7408 that is steerable along two planes (e.g., plane 4508 and plane 4510 shown in FIG. 45A. Steering along the planes is shown in FIGS. 45D and 45E and FIGS. 45F-45H, respectively). In certain embodiments, when the steerable catheter 7404 is in a neutral / straight configuration, the first steering surface of the proximally steerable portion 7408 can be coplanar with the steering surface of the distally steerable portion 7406, and the second steering surface of the proximally steerable portion 7408 can be orthogonal to the first steering surface of the proximally steerable portion 7408. The steerable catheter 7404 may also include one or more non-steerable catheter portions, such as a non-steerable catheter portion 7409. For example, the non-steerable catheter portion 7409 can extend from the proximally steerable portion 7408 to the handle assembly of the delivery system 7400.

[0464] The delivery system 7400 includes an inner tube 7410. The specific function of the inner tube 7410 can vary; at least in certain embodiments, the inner tube 7410 allows for the manipulation of an elongate element that passes through the steerable catheter 7404. In the delivery system 7400, the inner tube 7410 is also translatable relative to the steerable catheter 7404 to facilitate the positioning and placement of the implant 7402 during delivery and implantation. Examples of such extension and retraction are provided and described below with respect to FIGS. 79A-80B that show and describe the extension and retraction of the inner tube and the corresponding handle mechanism for performing the extension / retraction.

[0465] The present disclosure contemplates that the inner tube 7410 may have a substantially uniform structure, but in at least certain embodiments, the inner tube 7410 is divided into portions, and different rigidities and characteristics are associated with the bending of specific portions. The specific portions may also have non-uniform rigidities, such as having a first rigidity when bent along a first plane and / or in a first direction and a second different rigidity when bent along a second plane and / or in a second direction.

[0466] FIG. 75 shows the inner tube 7410 removed from the delivery system 7400. As shown, the inner tube 7410 is generally divided into four portions, each having a different structure. Although embodiments of the present disclosure can vary, the inner tube 7410 specifically includes a distal tube portion 7412, a first intermediate portion 7414, a second intermediate tube portion 7416, and a proximal tube portion 7418. Each portion of the inner tube 7410 may correspond to a specific portion of the steerable catheter 7404. For example, in the illustrated embodiment, the distal tube portion 7412 may correspond to the distal steerable portion 7406, the first intermediate portion 7414 may correspond to the proximal steerable portion 7408, the second intermediate tube portion 7416 may correspond to the distal segment of the non-steerable catheter portion 7409, and the proximal tube portion 7418 may correspond to the proximal segment of the non-steerable catheter portion 7409.

[0467] The specific structure of the inner tube 7410 can be various, but at least in certain embodiments, the inner tube 7410 is formed as an integral tubular structure. The material of the inner tube 7410 can also be various; in one specific embodiment, the inner tube 7410 is formed from stainless steel or a similar biocompatible material. In at least one embodiment, the inner tube 7410 is formed from a tube having an outer diameter of about 2.5 mm to about 3.5 mm and a wall thickness of about 0.1 mm to about 0.5 mm. For example, in one specific embodiment, the inner tube 7410 has an outer diameter of about 3 mm and a wall thickness of 0.25 mm.

[0468] Figures 76A - 76D show each part of the inner tube 7410 in more detail. Figure 76A is a side view of the distal tube portion 7412 of the inner tube 7410. When assembled with the steerable catheter 7404, the distal tube portion 7412 generally corresponds to the distal steerable portion 7406.

[0469] As described above, in the specific embodiment shown in FIG. 74, the distal steerable portion 7406 of the steerable catheter 7404 is steerable bidirectionally along a single plane. To accommodate such bending of the distal steerable portion 7406, the distal tube portion 7412 can be configured to have reduced rigidity with respect to bending along the steering plane of the distal steerable portion 7406.

[0470] In one specific embodiment, the stiffness of the distal tube portion 7412 is altered by a series of cuts that are longitudinally distributed along the distal tube portion 7412. More specifically, the distal tube portion 7412 includes a first cut 7420A that extends along a first side surface of the distal tube portion 7412 and a second cut 7420B that extends along a second side surface of the distal tube portion 7412. The first cut 7420A and the second cut 7420B reduce the stiffness of the distal tube portion 7412 against bending in the direction of the side surface along which the cut extends. In contrast, due to a "spine" (e.g., spine 7421) that extends along the distal tube portion 7412 between sets of cuts, a relatively high stiffness is maintained against bending in a direction orthogonal to the cut side surfaces. When the inner tube 7410 is disposed within the steerable catheter 7404, the first cut 7420A and the second cut 7420B are generally oriented perpendicular to the steering surface of the distal steerable portion 7406 so as to reduce the resistance of the distal tube portion 7412 along the steering surface to bending.

[0471] As shown in FIG. 76A, the first cut 7420A and the second cut 7420B each terminate in a bulbous notch, giving each cut an overall dog-bone shape. The dog-bone shape generally reduces interference of the inner cut surfaces during bending. In particular, doing so promotes more uniform bending of the distal tube portion 7412 and avoids binding of the distal tube portion 7412 during bending.

[0472] To maintain proper orientation between the inner tube 7410 and the steerable catheter 7404, a keyway 7422 or similar alignment mechanism of the distal tube portion 7412 can mate with a corresponding mechanism of the steerable catheter 7404.

[0473] FIG. 76A shows a lateral cut to reduce the bending stiffness along one plane, but the present disclosure contemplates that lateral cuts may also be used to reduce the stiffness of a given portion of the inner tube 7410 with respect to bending along multiple planes. For example, the inner tube 7410 may be deformed by including further cuts that are offset orthogonally from the first cut 7420A and the second cut 7420B and are disposed between adjacent cuts of the first cut 7420A and the second cut 7420B. By doing so, the stiffness of the inner tube 7410 can also be reduced with respect to bending along a second plane orthogonal to the first plane corresponding to the first cut 7420A and the second cut 7420B. More generally, by angularly offsetting the lateral cuts along the inner tube 7410, the inner tube 7410 can be made to have reduced stiffness along bending surfaces of any number and direction. The stiffness along a given bending surface can be controlled by changing the density, notch, depth, or other similar characteristics of the cuts corresponding to that bending surface. Thus, in embodiments where the inner tube 7410 has controlled stiffness in multiple directions or along multiple planes, the cut characteristics can be changed and controlled for each plane to impart direction / plane-specific bending characteristics.

[0474] FIG. 76B is a side view of a first intermediate portion 7414 of the inner tube 7410. As described above, in the specific embodiment shown in FIG. 74, the proximal manipulable portion 7408 of the steerable catheter 7404 is manipulable along two orthogonal planes. To accommodate such bending, the first intermediate portion 7414 can be configured to have reduced stiffness in all directions with respect to bending.

[0475] In one specific embodiment, the stiffness of the first intermediate portion 7414 is altered by one or more helical cuts, such as helical cut 7424, extending along the length of the first intermediate portion 7414. If the helical cut 7424 extends around the entire first intermediate portion 7414, it reduces the stiffness of the first intermediate portion 7414 in all directions compared to the stiffness of the first intermediate portion 7414 without such a cut.

[0476] FIG. 76C is a side view of a second intermediate tube portion 7416 of the inner tube 7410. As described above, in the specific embodiment shown in FIG. 74, the second intermediate tube portion 7416 may correspond to the distal segment of the non-maneuverable catheter portion 7409 of the maneuverable catheter 7404.

[0477] Although it does not require flexibility to receive manipulation, there may still be cases where a reduction in the stiffness of the second intermediate tube portion 7416 is desirable in certain applications and procedures. For example, when using the delivery system 7400 to deliver an implant to the valve annulus, the distal segment of the non-maneuverable catheter portion 7409 corresponding to the second intermediate tube portion 7416 is close to the heart and may even extend into the heart. As such, especially during changes in the insertion degree and / or rotation degree of the maneuverable catheter 7404, the distal segment of the non-maneuverable catheter portion 7409 may contact and exert force on the heart tissue and structure as well as the tissue and structure around the heart. Generally, the inner tube 7410 structurally reinforces the maneuverable catheter 7404 and contributes to the contact force between the maneuverable catheter 7404 and the surrounding tissue. Therefore, by reducing the stiffness of the second intermediate tube portion 7416, the degree of structural reinforcement provided to the distal segment of the non-maneuverable catheter portion 7409 and the corresponding contact force applied by the non-maneuverable catheter portion 7409 can be reduced.

[0478] In one specific embodiment, the stiffness of the second intermediate tube portion 7416 is altered by one or more helical cuts, such as helical cut 7426, extending along the length of the second intermediate tube portion 7416. If the helical cut 7426 extends around the entire second intermediate portion 7416, it reduces the stiffness of the second intermediate portion 7416 in all directions. Compared to the helical cut 7424 of the first intermediate portion 7414, the helical cut 7426 of the second intermediate tube portion 7416 is shown to have a greater pitch and to result in a smaller reduction in the stiffness of the second intermediate tube portion 7416.

[0479] FIG. 76D is a side view of the proximal tube portion 7418 of the inner tube 7410. As shown, the proximal tube portion 7418 does not include any particular modifications to change the overall stiffness of the proximal tube portion 7418. However, as shown, the proximal tube portion 7418 may include a coupling mechanism 7428, such as an elongated through-hole, to allow longitudinal translation of the inner tube 7410 relative to the steerable catheter 7404 while maintaining rotational alignment of the inner tube 7410 relative to the steerable catheter 7404 and coupling to the handle of the delivery system 7400.

[0480] The present disclosure contemplates varying the various cut aspects shown in FIGS. 76A-76C to impart various stiffness reductions to the inner tube 7410 and to adjust the stiffness of the inner tube 7410 for a given application. For example, referring to the transverse cuts shown in FIG. 76A, the density of the cuts (i.e., the number of cuts per unit length of the inner tube 7410), the width of the cut opening, the depth of the cut, and similar features can be varied to change the stiffness. Similarly, referring to the helical cuts shown in FIGS. 76B and 76C, the pitch, the cut opening, the helix angle, and similar features can be varied to change the stiffness of the inner tube 7410.

[0481] Figures 76A - 76C show cuts passing through the wall of the inner tube 7410, but the present disclosure also contemplates that any cut may only partially pass through the wall of the inner tube 7410, and that the depth of the cut generally is proportional to the reduction in stiffness provided by that cut. The present disclosure also contemplates that the stiffness of each portion of the inner tube 7410 may be changed by other methods including, but not limited to, changes in wall thickness, changes in tube material, changes in tube shape, and the like.

[0482] The specific dimensions of the inner tube 7410 can vary. However, in certain embodiments, the inner tube 7410 can be from about 1400 mm to about 1800 mm. For example, in one embodiment, the inner tube 7410 can be about 1540 mm in length. Each portion of the inner tube 7410 can similarly have various lengths. For example, in one embodiment, the distal tube portion 7412 can terminate at its distal end with a keyway or similar non-rotational mechanism that is from about 40 mm to about 80 mm in length. For example, the distal tube portion 7412 can be about 60 mm in length. In certain embodiments, the first intermediate portion 7414 can be from about 90 mm to about 130 mm. For example, the first intermediate portion 7414 can be about 110 mm in length. In certain embodiments, the helical cut of the first intermediate portion 7414 can have a pitch of from about 0.4 mm to about 0.6 mm, such as 0.5 mm. In some embodiments, the helical cut of the first intermediate portion 7414 is continuous; in other embodiments, it can be an intermittent cut having a cut length of from about 2 mm to about 4 mm and portions without a cut of from about 0.5 mm to about 0.8 mm interspersed therebetween. However, more generally, each of the distal tube portion 7412 and the first intermediate portion 7414 can be approximately the same length as the corresponding manipulable portion of the delivery catheter in which they are disposed. The second intermediate tube portion 7416 can similarly have various lengths. For example, in certain embodiments, the second intermediate tube portion 7416 can be from about 500 mm to about 700 mm in length. In one specific example, the second intermediate tube portion 7416 is about 630 mm in length. In certain embodiments where the second intermediate tube portion 7416 has a helical cut, the helical cut of the second intermediate tube portion 7416 can have a pitch of from about 1 mm to about 2 mm, such as 1.5 mm. The helical cut of the second intermediate tube portion 7416 can similarly be either non-intermittent or intermittent. If the helical cut is intermittent, it can include cut-in segments of from about 3 mm to about 4 mm, such as 3.5 mm, and segments without a cut of from about 0.5 mm to 1.2 mm, such as 0.9 mm.Finally, in certain embodiments, the proximal tube portion 7418 can be from about 600 mm to about 800 mm and, in one specific example, is about 740 mm.

[0483] XXII. Delivery Tool Handle for Delivery of Expandable Implants The delivery tool according to the present disclosure generally includes a handle assembly having various control elements and a catheter assembly extending from the handle assembly. During delivery of the implant, the implant is at least partially retained within the distal end of the catheter assembly. After insertion of the catheter assembly by the physician and placement of the distal end of the catheter assembly, the physician deploys the implant from the distal end of the catheter assembly. Deployment generally includes fully exposing the implant, for example, by retracting a protective sheath and / or extending the implant distally from the distal end of the catheter assembly, and, once exposed, expanding the implant to an expanded configuration in preparation for implantation. After final placement and implantation of the expanded implant, the physician detaches the implant from the distal end of the catheter assembly and withdraws the delivery tool from the patient.

[0484] The process requires substantial control and manipulation of the delivery tool and implant, including manipulation of the catheter assembly, extension and retraction of the implant relative to the catheter assembly, expansion and contraction of the implant, and release of the implant. Exemplary manipulation mechanisms and corresponding handle mechanisms and functions are described above with respect to FIGS. 45-49. As described with respect to these figures, the handle assembly can include levers or similar manipulation control elements configured to manipulate portions of the catheter assembly independently and in multiple directions. For example, FIG. 45 shows one exemplary embodiment in which the distal portion of the catheter assembly is divided into a proximal manipulation portion and a distal manipulation portion, each of which is independently articulable.

[0485] In addition to the manipulation of the catheter, certain embodiments of the present disclosure include elements for controlling the rotation and insertion of the catheter assembly. For example, FIG. 61 shows an exemplary delivery device that includes rails and a cradle that support the delivery device. The cradle is movable / translatable along the rails (e.g., by turning a corresponding knob) to control insertion. The cradle also includes a rotatable mount for the delivery device such that the delivery device can be rotated within the cradle while maintaining longitudinal alignment.

[0486] FIGS. 77A - 78C show a similar attachment device for enabling both insertion and rotation of the delivery device. FIG. 77A is a photograph of an implant delivery system 7700 that includes a delivery device 7702 supported by an attachment assembly 7704 that includes a cradle 7706. The cradle 7706 is supported by a rail 7708 that is supported by a multi - joint arm 7710. Although not shown, the multi - joint arm 7710 can be coupled to a patient bed or similar equipment within the surgical environment. Similar to the attachment device shown in FIG. 61, the cradle 7706 includes a stepper - type multi - joint system that is manually driven by a knob 7712. More specifically, when the physician turns the knob 7712 (as shown in FIG. 77B), the cradle 7706 translates in a corresponding direction along the rail 7708, thereby controlling the insertion of the delivery device 7702.

[0487] Figures 78A - 78C show the rotation of the delivery device 7702 within the cradle 7706 of the attachment assembly 7704. Figure 78A shows the delivery device 7702 in the neutral position. To change the rotational position of the delivery device 7702, a physician can manually rotate the delivery device 7702 within the cradle 7706. Figure 78B shows the delivery system 7700 when the physician manually rotates it in the first direction from the neutral position of Figure 78A, and Figure 78C shows the delivery device 7702 after the physician rotates it in the opposite direction from the neutral position. Notably, regardless of the direction of rotation, the longitudinal axis of the delivery device 7702 remains in a fixed position. The amount of rotation provided by the attachment assembly 7704 can vary, but in at least certain embodiments, the attachment assembly 7704 can be configured to provide up to approximately 180° total rotation of the delivery device 7702, for example, 90° of rotation in the clockwise or counterclockwise direction relative to neutral.

[0488] In addition to rotation and insertion, the delivery systems according to the present disclosure can be actuated and controlled in other ways by corresponding control elements included in the handle assembly. As a non - limiting example, such additional degrees of freedom and articulation can include the extension of the implant relative to the distal end of the delivery catheter, the controlled expansion and contraction of the implant prior to release, and the controlled release of the implant from the distal end of the delivery catheter, each of which will be described in further detail below.

[0489] First, FIGS. 79A - 80B illustrate an exemplary embodiment of a delivery device 7900 having a handle assembly 7902. Similar to other delivery devices and systems of the present disclosure, the delivery device 7900 generally includes a steerable catheter assembly 7904. An implant 7950 can be disposed at the distal end 7906 of the catheter assembly 7904 for delivery and implantation. The catheter assembly 7904 includes a steerable catheter body 7908 and an extension tube 7910. During operation, as described with respect to FIGS. 54A and 54B and FIGS. 74 - 76E, the extension tube 7910 is capable of extension and retraction relative to the distal end 7906, facilitating the positioning, orientation, and placement of the implant 7950 relative to the valve annulus.

[0490] In one exemplary tricuspid valve repair procedure, while delivering the distal end 7906 of the delivery device 7900 to the right atrium, with the implant 7950 coupled to the distal end 7906, the implant 7950 is retracted and maintained in a form housed within the sheath. With the distal end 7906 in the right atrium, the physician exposes the implant 7950 from the sheath, expands it, and aligns it perpendicular to the tricuspid valve annulus, for example, by manipulating the catheter assembly 7904. Once alignment is complete, the extension tube 7910 is extended to translate the implant 7950 into the valve annulus in preparation for subsequent release.

[0491] FIGS. 79A - 79D show the general operation of the handle assembly 7902 of the delivery device 7900 for performing extension and retraction of the implant 7950. More specifically, FIGS. 79A and 79C are photographs of the handle assembly 7902 whe...

Claims

**Claim 1** A delivery device for a heart valve repair implant, comprising: A delivery catheter; An extension member protruding from the distal end of the delivery catheter; and A control arm assembly releasably couplable to the valve repair implant, the control arm assembly including a pair of control arms, wherein the pair of control arms includes A distal control arm coupled to and extending proximally from the distal end of the extension member; and A proximal control arm coupled to the distal control arm and extendable from the distal end of the delivery catheter to laterally expand the control arm assembly, the delivery device. **Claim 2** The delivery device according to claim 1, wherein the pair of control arms is one of a plurality of pairs of control arms of the control arm assembly, each pair of control arms including a respective distal control arm and a respective proximal control arm. **Claim 3** The delivery device according to claim 2, wherein each proximal control arm of each pair of control arms can be simultaneously extended from the distal end of the delivery catheter to laterally expand the control arm assembly. **Claim 4** The delivery device further includes a control arm shaft disposed within the delivery catheter, the control arm shaft being coupled to the proximal portion of the control arm assembly and translatable relative to the delivery catheter, wherein by translating the control arm shaft, each proximal control arm of each pair of control arms can be simultaneously extended from the distal end of the delivery catheter to laterally expand the control arm assembly. The delivery device according to claim 2. **Claim 5** The delivery device according to claim 1, further comprising a control assembly coupled to the proximal end of the delivery catheter and a control arm extension member shaft extending through the delivery catheter and coupled to the proximal control arm, the control assembly including a control mechanism for selectively extending and retracting the proximal control arm by translating the control arm extension member shaft. **Claim 6** The delivery device according to claim 1, further comprising a deflector disposed distal to the distal end of the delivery catheter, the deflector directing the proximal control arm laterally when the proximal control arm is extended from the distal end of the delivery catheter. **Claim 7** The delivery device according to claim 1, wherein the distal control arm is rigidly coupled to the distal end of the extension member, and the distal control arm bends laterally when the proximal control arm is extended from the distal end of the delivery catheter.

8. The delivery device according to claim 1, wherein the extension member is selectively extendable from the distal end of the delivery catheter.

9. The delivery device according to claim 8, further comprising a control assembly coupled to the proximal end of the delivery catheter, the control assembly including a control mechanism for selectively extending and retracting the extension member from the distal end of the delivery catheter.

10. The delivery device according to claim 1, further comprising a control assembly coupled to the proximal end of the delivery catheter and an extension member shaft extending through the delivery catheter and coupled to the extension member, the control assembly including a rotatable knob for selectively extending and retracting the proximal control arm by translating the extension member shaft.

11. The delivery device according to claim 1, further comprising a sheath disposed around the delivery catheter, the sheath being translatable between a first position in which the sheath extends over the extension member and a second position in which the extension member is at least partially exposed.

12. The delivery catheter includes a first manipulable portion and a second manipulable portion, the first manipulable portion being distal to the second manipulable portion, the first manipulable portion being manipulable independently of the second manipulable portion, The delivery device according to claim 1.

13. The delivery device according to claim 12, wherein the first manipulable portion and the second manipulable portion are manipulable along a common plane.

14. The delivery device according to claim 13, wherein the second manipulable portion is further manipulable along a second plane orthogonal to the common plane.

15. The delivery device according to claim 1, wherein the proximal control arm is coupled to the proximal end of the distal control arm.

16. The delivery device according to claim 1, wherein the proximal control arm is coupled to the distal control arm at a position within the proximal half of the distal control arm.

17. The delivery device according to claim 1, wherein the distal control arm includes a distal curved portion concave in the distal direction and a proximal curved portion concave in the proximal direction.

18. The delivery device according to claim 1, further comprising at least one tightening line that extends through the delivery catheter and can be selectively retracted and extended relative to the delivery catheter.

19. The delivery device according to claim 18, further comprising a control assembly coupled to the proximal end of the delivery catheter, the control assembly including control mechanisms for each of extending the control arm assembly and simultaneously feeding out at least one tightening line, and folding the control arm assembly and simultaneously retracting the at least one tightening line.

20. A delivery device for a heart valve repair implant, a delivery catheter; an extension member protruding from the distal end of the delivery catheter; and a control arm assembly releasably coupleable to the valve repair implant, the control arm assembly including a plurality of control arm pairs circumferentially distributed around the extension member comprising, each control arm pair of the plurality of control arm pairs a distal control arm coupled to and extending proximally from the distal end of the extension member; and a proximal control arm coupled to the distal control arm and extendable from the distal end of the delivery catheter to laterally expand the control arm assembly a delivery device.

21. The delivery device according to claim 20, further comprising a control arm extension member shaft that extends through the delivery catheter and is coupled to each proximal control arm of the plurality of control arm pairs, the control arm extension member shaft being selectively translatable relative to the delivery catheter to expand and contract the control arm assembly.

22. The delivery device according to claim 20, further comprising at least one tightening line that extends through the delivery catheter and can be selectively retracted and extended relative to the delivery catheter.

23. The delivery device further includes a control assembly coupled to the proximal end of the delivery catheter, the control assembly including control mechanisms for each of extending the control arm assembly and simultaneously feeding out the at least one tightening line, and folding in the control arm assembly and simultaneously retracting the at least one tightening line, the delivery device of claim 22.

24. The delivery catheter includes a first manipulable portion and a second manipulable portion, wherein the first manipulable portion is distal to the second manipulable portion, the first manipulable portion is manipulable independently of the second manipulable portion, each of the first manipulable portion and the second manipulable portion is manipulable along a common plane; the second manipulable portion is further manipulable along a second plane orthogonal to the common plane, the delivery device of claim 20.

25. A delivery device for a heart valve repair implant, a delivery catheter; an extension member protruding from the distal end of the delivery catheter; and a control arm assembly releasably coupleable to the valve repair implant, the control arm assembly including a pair of control arms including, the pair of control arms including a distal control arm coupled to and extending proximally from the distal end of the extension member; and a proximal control arm coupled to the proximal portion of the distal control arm and extendable from the distal end of the delivery catheter to expand the control arm assembly laterally, the proximal control arm including, the delivery catheter including a distal portion including a plurality of independently manipulable portions, a delivery device.

26. The delivery device of claim 25, wherein the plurality of independently manipulable portions include a first manipulable portion and a second manipulable portion, each of the first manipulable portion and the second manipulable portion being manipulable along a common plane.

27. The delivery device of claim 26, wherein the first manipulable portion is distal to the second manipulable portion, and the second manipulable portion is further manipulable along a second plane orthogonal to the common plane.

28. The control arm pair is one of a plurality of control arm pairs of the control arm assembly, each control arm pair including a respective distal control arm and a respective proximal control arm, the delivery device according to claim 25.

29. The delivery device further includes a control arm shaft disposed within the delivery catheter, the control arm shaft being coupled to a proximal portion of the control arm assembly and being translatable relative to the delivery catheter, by translating the control arm shaft, each proximal control arm of each control arm pair can be simultaneously extended from the distal end of the delivery catheter to expand the control arm assembly laterally. The delivery device according to claim 28.

30. The delivery device according to claim 25, wherein the extension member is selectively extendable from the distal end of the delivery catheter.

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