EP4536148A1 - Système et procédé de réparation de valvule cardiaque - Google Patents

Système et procédé de réparation de valvule cardiaque

Info

Publication number
EP4536148A1
EP4536148A1 EP23820382.2A EP23820382A EP4536148A1 EP 4536148 A1 EP4536148 A1 EP 4536148A1 EP 23820382 A EP23820382 A EP 23820382A EP 4536148 A1 EP4536148 A1 EP 4536148A1
Authority
EP
European Patent Office
Prior art keywords
implant
control arm
proximal
distal
frame
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP23820382.2A
Other languages
German (de)
English (en)
Inventor
Jeremy J. Boyette
Daniel T. Wallace
Juan GRANADA
Peter W. GREGG
Spencer C. NOE
Evelyn N. Haynes
Andrew Backus
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Versa Vascular Inc
Original Assignee
Versa Vascular Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Versa Vascular Inc filed Critical Versa Vascular Inc
Publication of EP4536148A1 publication Critical patent/EP4536148A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/005—Rosette-shaped, e.g. star-shaped

Definitions

  • the present disclosure relates to medical systems and methods for repairing a cardiac valve. More specifically, the present disclosure pertains to a cardiac valve repair implant that is minimally invasively deliverable and implantable via an associated minimally invasive delivery tool.
  • Cardiac valve regurgitation occurs when a cardiac valve does not close completely, causing blood to leak back through the valve.
  • the causes of regurgitation may vary.
  • Functional regurgitation is caused by changes to the heart geometry near the valve, where, for example, the heart enlarges, inducing both geometrical distortion around the valve annulus and insufficient leaflet coaptation during valve closure.
  • Degenerative regurgitation is caused by a disease of the valve itself, where, for example, the leaflets may thicken and be unable to seal completely. In both cases, the patient suffers because high-pressure blood in the ventricle regurgitates through the valve into the low-pressure venous system.
  • the percutaneous clip procedure is costly and difficult to perform, particularly by inexperienced operators. Further, the feasibility of the percutaneous clip procedure for the tricuspid valve is unproven and may be less effective in a three-leaflet valve.
  • the mechanisms of valvular regurgitation are multiple and fixing a single mechanism of disease (e.g., leaflet grasping) may temporarily reduce the severity of regurgitation but not improve the natural history of the disease (e.g., deterioration over time).
  • 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 coupleable to a valve repair implant.
  • the control arm assembly includes multiple control arm pairs distributed circumferentially about 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 extendable from the distal end of the delivery catheter to laterally expand the control arm assembly.
  • FIG. 2 is a perspective distal-side view of the implantable cardiac valve repair in an expanded state that is used when the implant is implanted in the cardiac valve.
  • FIG. 4 is a perspective proximal-end view of the implantable cardiac valve repair implant in the expanded state.
  • FIG. 8 is an enlarged view of the distal region of the cardiac repair system of FIG. 1A.
  • FIG. 9 is a side cross-sectional elevation view of a sheath of the delivery tool with the implantable cardiac valve repair implant maintained in the collapsed state by being confined within the sheath, the implant being coupled to a distal end of a catheter that extends through the sheath.
  • FIG. 10 is a view of the implantable cardiac valve repair implant implanted in a target cardiac valve, as viewed from an atrial position looking towards the valve and the ventricle chamber below.
  • FIGS. 11A-11C are illustrations of a system for repairing a cardiac valve and, more specifically, a plan view, side elevation view, and a plan view illustrating a range of motion of a delivery tool of the system, respectively.
  • FIG. 15 is a side cross-sectional elevation view of a distal portion of the delivery tool of FIG. 13 coupled to the implant.
  • FIG. 16 is a photograph of a distal perspective view of the implant coupled to the delivery tool and in an expanded state.
  • FIG. 18 is a photograph of a second detailed view of a connection between the delivery tool and the tension control line of the implant.
  • FIG. 19 is a photograph of a plan view of the delivery tool illustrating protrusion of tension control members through a release catheter of the delivery tool.
  • FIG. 20 is a side cross-sectional view of the delivery tool coupled to the implant with the implant in an expanded configuration.
  • FIG. 21 is a side cross-sectional view of the delivery tool and the implant during release of the implant from the delivery tool.
  • FIG. 22 is a side cross-sectional view of the delivery tool and the implant following release of the implant from the delivery tool.
  • FIG. 23 is a side elevation view of a distal portion of an implant.
  • FIG. 29C is a simplified elevation view of an implant including a proximal portion having a proximally concave shape and a distal portion having a distally concave shape.
  • FIG. 30A is a simplified elevation view of a frustoconical implant.
  • FIG. 30B is a simplified elevation view of a planar implant.
  • FIG. 32 is a distal-end view of an implant having a frame including distally open arcuate petal portions.
  • FIG. 38 is a photograph of proximal a distal end of the delivery device of FIG. 36 including a valve repair implant coupled to the distal end of the delivery device.
  • FIG. 45A is a photograph of a side view of a distal end of the delivery device of FIG. 36 illustrating steerable sections of the delivery device.
  • FIGS. 45B and 45C are photographs of the delivery device of FIG. 36 illustrating steering of a distal steering section of the delivery device.
  • FIGS. 45F-45H are photographs of the delivery device of FIG. 36 illustrating steering of the proximal steering section along a second plane, orthogonal to the first plane.
  • FIG. 46 is a photograph of a control assembly for steering the delivery device of FIG. 36.
  • FIG. 50 is a photograph illustrating a delivery device according to this disclosure with an implant coupled to a distal end and a sheath extended over the implant.
  • FIG. 51 is a radiographic image of a delivery device according to this disclosure including a sheath with an embedded radiopaque marker.
  • FIGS. 54A and 54B are photographs of the distal end of the delivery device of FIG. 36 including a deployed implant in a fully extended and a de-extended/retracted configuration, respectively.
  • FIG. 55 is a photograph of a control assembly for use with the delivery device of FIG. 36, the control assembly including controls for each of extending/retracting an extension member, expanding and collapsing a control arm assembly, and controlling tension of a cinch line.
  • FIG. 56 is a side view of a distal portion of the delivery device of FIG. 36 with a control arm assembly in a collapsed state.
  • FIG. 59 is a detailed photograph illustrating coupling of an implant to the control arm assembly via a cinch line.
  • FIG. 60 is a photograph of a control assembly of a delivery device according to the present disclosure.
  • FIG. 61 is a photograph of a control assembly and mount for use with delivery devices of the present disclosure.
  • FIG. 63A is a proximal-side perspective view of another implant according to the present disclosure.
  • FIG. 63B is a distal-side perspective view of the implant of FIG. 63A.
  • FIGS. 63C and 63D are distal views of the implant of FIG. 63A.
  • FIGS. 64D and 64E are additional views of the implant of FIG. 63A indicating the location of specific structures of the implant.
  • FIG. 64F is a detailed view of a spoke of the frame of FIGS. 64A-64E.
  • FIG. 64G is a detailed view of an anchor member of the frame of FIGS. 64A-64E,
  • FIG. 64K is a detailed view of outer petal portions of the frame of FIGS. 64A-64E.
  • FIGS. 64L and 64M are dimensioned side views of the frame of FIGS. 64A-64E.
  • FIG. 64N is a detailed and dimensioned side view of a spoke of the frame of FIGS. 64A-64E.
  • FIGS. 65A and 65B are a distal view and a proximal-side perspective view, respectively of a laminated occluder.
  • FIG. 65C is a distal-side isometric view of the frame of FIGS. 64A-64E with the laminated occluder attached.
  • FIGS. 65E and F are dimensioned distal and elevation views of the frame and laminated occluder of FIG. 65C.
  • FIG. 66A is a distal-side perspective view of an alternative laminated occluder including a proximally convex back.
  • FIG. 66B is a proximal-side perspective view of the alternative laminated occluder of FIG. 66A.
  • FIG. 67A is an elevation view of the implant of FIG. 63A illustrating an outer sheet coupled to the implant frame.
  • FIGS. 67B-D are detailed views of the coupling between the outer sheet and frame of the implant of FIG. 63A.
  • FIG. 72 is a detailed view of a junction of the frame of the implant of FIG. 63A including a slot for receiving an eyelet.
  • FIG. 73A and 73B are cross-sectional views of the implant of FIG. 63A illustrating coupling of the eyelet to the frame with FIG. 73B further illustrating coupling of the implant to a delivery device control arm.
  • FIGS. 78A-78C are additional views of the mounting assembly and delivery system of FIGS. 77A and 77B illustrating rotation of the delivery system.
  • FIGS. 79A and 79B are elevation views of a handle assembly and a distal end of a delivery system illustrating distal extension of an implant coupled to the delivery system.
  • FIGS. 79C and 79D are elevation views of the handle assembly and the distal end of the delivery system illustrating distal retraction of the implant coupled to the delivery system.
  • FIGS. 80A and 80B are internal views of the handle assembly in the extended and retracted states, respectively.
  • FIGS. 82A is an internal view of the handle assembly in the collapsed state.
  • FIGS. 82C is an internal view of the handle assembly in the expanded state.
  • FIG. 87A is an isometric view of a mounting assembly for use with delivery devices according to this disclosure.
  • FIG. 87B is an isometric view of a handle mount assembly of the mounting assembly of FIG. 87A.
  • FIG. 87C is a detailed view of a rail assembly of the of the mounting assembly of FIG. 87A.
  • FIGS. 87D and 87E are isometric views of a rail assembly, carriage assembly, and interface of the mounting assembly of FIG. 87A in a decoupled state.
  • FIGS. 87J and 87K are isometric views of a carriage assembly of the mounting assembly of FIG. 87A.
  • FIGS. 88D and 88E are detailed views of a joint between control arms of the control arm assembly of FIG. 88B.
  • FIG. 90 is a flow chart illustrating an example method of delivering a cardiac valve repair implant according to this disclosure.
  • the tool proximal end 30 includes a control handle 35 used by a physician to manipulate the tool 15 in positioning the implant 20 at the target site and deploying the implant 20 within the target site, which is a cardiac valve in need of repair, as discussed in detail later in this Detailed Description.
  • the tool 15 is used for minimally invasive delivery and deployment of the implant 20 in the cardiac valve in need of repair.
  • the system and its implant are advantageous in that the implant may be delivered and deployed at the target site via an antegrade percutaneous route (e g., a trans-femoral ortrans-jugular route) with the patient consciously sedated during the procedure.
  • the annular surface 62 may also be conical, or relatively so (e.g., parabolic), such that its proximal side, which faces the atrial chamber when the implant 20 is implanted in the target cardiac valve as depicted in FIG. 10, serves as a funnel arrangement distally leading from the atrial chamber towards the central opening 66 of the implant 20 and the valve opening distal the central opening 66.
  • the distal side of the annular surface 62 may also be conical to generally make mating surface contact with the semi- conical regions of the atrial wall surface and surrounding annular region of the target cardiac valve, as can be understood from FIG. 10.
  • FIG. 7 is a side view of the implant collapsed to allow its delivery to the target site via the tool 15, the frame 55 and thin sheet 60 collapse symmetrically about the central longitudinal axis 70.
  • FIGS. 2-6 when in the expanded state to the implant 20 in FIG. 7 in the collapsed state indicates that the implant can transition from the collapsed state to the expanded state similar to an umbrella.
  • the implant 20 is maintained in the collapsed state of FIG. 7 by the tool 15 so as to allow the implant to be negotiated through the patient vascular system and into an atrial chamber of the heart for implantation of the implant within a target cardiac valve.
  • the implant 20 may be delivered and deployed at the target site via an antegrade percutaneous route (e.g., an antegrade trans-femoral or trans-jugular route) with the patient consciously sedated during the procedure.
  • the physician actuates the tool 15 such that the tool no longer maintains the implant 20 in the collapsed state, as can be understood from FIG. 1A. Since the frame 55 of the implant 20 is biased to self-expand into the expanded state of FIGS. 2-6, the implant self-expands into the expanded state to anchor itself within the target cardiac valve and reduce regurgitation, as shown in FIG. 10.
  • the central occluder 50 may take the form of a bullet or conical shape.
  • the central occluder may have a cylindrical side 85 extending distally from the central occluder proximal end 65 and then transitioning to a bullnose 90 that distally extends to the central occluder extreme distal tip 75.
  • a bullet or conical shape results in the central occluder 50 being atraumatic for delivery and implantation purposes. Further, such a shape facilitates the cylindrical side 85 of the central occluder substantially sealing against the cardiac valve leaflets, thereby materially reducing, if not eliminating, central regurgitation past the cardiac valve leaflets.
  • the general shape of the bullnose 90 may also vary across embodiments.
  • the bullnose 90 may have any of a parabolic profile, a conical profile, a spherical profile, or any other atraumatic profile.
  • the bullnose 90 may have a trihedral, frustoconical shape, or other non-rounded shape.
  • the central occluder 50 may have a triangular or tri-lobe shape that provides surfaces for sealing against respective leaflets.
  • the central occluder 50 may have a rounded double-concave shape.
  • the central occluder 50 may be configured to allow distention of a distal portion of the frame 55, thereby facilitating reintervention (e.g., valve implantation).
  • the central occluder 50 may include a frame (e.g., inner struts) covered in a flexible material, such as, but not limited to expanded polytetrafluoroethylene (ePTFE), polyester fabric, or a similar material.
  • ePTFE expanded polytetrafluoroethylene
  • polyester fabric or a similar material.
  • the flexible covering may allow the central occluder 50 to be compressed for delivery but to expand once positioned in the native valve to occlude and reduce regurgitation.
  • the thin sheet 60 may be on the distal side of the frame 55, the proximal side, or both such that the frame extends through and along the thin sheet.
  • the frame 55 is covered with a thin sheet 60 on the distal side of the frame where the frame contacts atrial tissue when the implant 20 is implanted in the target cardiac valve.
  • the thin sheet 60 has an outer diameter DS.
  • the outer diameter DS may be between approximately 40 mm and approximately 80 mm, between approximately 50 mm and approximately 70 mm, or between approximately 55 mm and approximately 65 mm.
  • the thin sheet 60 has a radial width RW. In certain embodiments, the radial width RW may be between approximately 10 mm and approximately 30 mm, between approximately 13 mm and approximately 23 mm, or between approximately 17 mm and approximately 19 mm.
  • the thin sheet 60 has a central opening 66 with an inner diameter DI.
  • the wall thickness WT may be between approximately 0.2 mm and 0.8 mm, between approximately 0.3 mm and approximately 0.7 mm, or between approximately 0.4 mm and approximately 0.6 mm.
  • the spokes 95 may conform to certain spoke aspect ratios, which, in the context of the spokes 95 refers to the ratio of the wall thickness WT to the strut width SW.
  • embodiments may have a spoke aspect between 4:0.5 and 1 :2, between 3:1 and 1 :1.2, or between 2:1 and 1 :1.
  • the frame 55 engages the atrial tissue via the protruding anchor members 105, which may be in the form of small barbs.
  • the protruding anchor members 105 are designed to securely engage the atrial tissue without penetrating through the tissue or to the coronary vessels.
  • the protruding anchor members or barbs 105 may be curved to slide before engaging tissue. There may be one row or multiple rows of retention barbs 105.
  • protruding anchor members 105 may have an aspect between 4:0.5 and 1 :2, between 3:1 and 1 :1.2, or between 2:1 and 1 :1.
  • the cross-sectional radios of curvature CSR may be between approximately 2 mm and approximately 6 mm, between approximately 3 mm and approximately 5 mm, or between approximately 3.5 mm and approximately 5 mm.
  • Each protruding anchor member 105 has a wall thickness WT of approximately 0.46 mm, an aspect ratio of approximately 2:1 (resulting in a strut width SW of approximately 0.23 mm), a cross-sectional radius of curvature CSR of approximately 5 mm, and a length of approximately 1.5 mm.
  • each of the protruding anchor members 105 may be dimensionally identical; however, in other embodiments, one or more of the protruding anchor members 105 may differ in any of the various characteristics noted above.
  • the anchors or barbs 105 are directionally reversed such that they project distally and radially inward.
  • the delivery system overexpands the frame 55 during delivery and when the frame is released from the delivery system with the frame 55 in contact with tissue, the anchors or barbs 105 engage the atrial tissue as the frame 55 contracts to its relaxed state.
  • the catheter 77 may employ steering via selective actuation (e.g., tension increase/decrease) of certain sutures to better control the position of the implant during deployment.
  • This steering feature may be controlled at the handle 35.
  • the exposed ends of the control sutures 130 are cut near their points of securement to the implant frame 55, and the catheter distal end 25 is released (e.g., unscrewed or otherwise decoupled) from the proximal end 65 of the central occluder 50. With the tool 15 so decoupled from the implanted implant, the tool can be withdrawn from the patient.
  • FIGS. 11A and 11 B are plan and side elevation views, respectively, of an alternative valve repair system 1100 according to the present disclosure. Similar to valve repair systems previously discussed herein, the valve repair system 1100 is generally configured to deliver and deploy an implant 20 at a target site, which is generally in a cardiac valve requiring repair. Embodiments of the valve repair system 1100 may be used with, but are not limited to being used with, any implants discussed herein or that are otherwise consistent with this disclosure.
  • steering of the distal end 1125 is achieved by coupling the steering control 1180 to a steering segment 1182 disposed along the catheter 1177, distal the steering control 1180.
  • the steering control 1180 may include lateral members 1184A, 1184B, each of which is coupled to a respective side of a distal end of the steering segment 1182 by respective pull wires 1186A, 1186B. Accordingly, when the steering control 1180 is rotated, the corresponding pull wire is pulled and the steering segment 1182 is made to bend in the same direction. For example, referring to FIG. 11 C, when the steering control 1180 is rotated counterclockwise with respect to the view of FIG.
  • the lateral member 1184A pulls the pull wire 1186A, resulting in the distal end 1125 curling in a counterclockwise direction, as illustrated by dashed outline 1192A.
  • the steering control 1180 is rotated clockwise with respect to the view of FIG. 11C, as illustrated by dashed outline 1190B, the lateral member 1184B pulls the pull wire 1186B, resulting in the distal end 1125 curling in a clockwise direction, as illustrated by dashed outline 1192B.
  • the pull wires 1186A, 1186B are run within an annular space defined between the sheath 1176 and the catheter 1177.
  • the pull wires 1186A, 1186B may be run through a lumen defined within a wall of the catheter 1177, a wall of the sheath 1176, or a third annular body disposed along the distal length of the tool 1115.
  • the catheter 1177 or an additional tubular sheath disposed between the catheter 1177 and the sheath 1176 may be formed as a triple lumen extrusion including a central lumen and a pair of smaller lumens disposed on opposite sides of the central lumen and through which the pull wires 1186A, 1186B extend.
  • the tension control line 200 is releasably coupled to tension control members (e g., tension control members 320 illustrated in FIGS. 13-22 and discussed below in further detail) of a delivery tool (e.g., delivery tool 300, similarly illustrated in FIGS. 13-22 and discussed below).
  • tension control members e.g., tension control members 320 illustrated in FIGS. 13-22 and discussed below in further detail
  • the tension control members may be coupled to a handle or similar actuatable component of the delivery tool (such as the handle 35 of the tool 15 previously discussed), to vary tension applied to the tension control line 200 by the tension control members.
  • rotating the handle 35 in a first direction may cause the tension control members to translate proxi m al ly/retract, thereby increasing tension on the tension control line 200
  • rotating the handle 35 in an opposite direction may cause the tension control members to translate distally/extend, thereby reducing tension on the tension control line 200.
  • manipulating the handle 35 in a first direction generally stops expansion of and/or collapses the frame 55 of the implant 20 (e.g., to allow repositioning of the implant 20)
  • manipulating the handle 35 in a second direction generally stops collapse of the frame and/or expands the frame 55, whether by action of the handle 35 or as a result of a bias of the frame 55 to into the expanded configuration.
  • the tension control line 200 is releasably retained by the tension control members at discrete locations along the length of the tension control line 200.
  • the tension control line 200 extends across the frame 55 and is coupled to the frame 55 at multiple locations.
  • tension modifications may be applied at the connection point between the tension control members and the tension control line 200, tension is distributed relatively evenly across the tension control line 200 and the frame 55, thereby providing even expansion and collapse of the frame 55 and improved control during deployment and placement of the implant 20.
  • the tension control line 200 is coupled to (e.g., tied or adhered to) the inner arcuate members 115 of the frame 55. More generally, the tension control line 200 may be coupled to any suitable portion of the frame 55 such that the tension control line 200 substantially extends about the frame 55. For example, and without limitation, in other implementations of the present disclosure, the tension control line 200 may instead be fixed to spokes 95, outer arcuate members 110, or any other suitable portion of the petal portions 100 of the frame 55.
  • the tension control line 200 may be additionally coupled to other locations of the frame 55 by additional control segments or linking structures.
  • FIG. 12 illustrates the tension control line 200 coupled to the inner arcuate members 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 the link 202.
  • the link 202 may be formed of wire, suture, or similar material and, in certain cases, may be formed of the same material as the control line 200. In operation, the link 202 helps to further distribute tension to the outer arcuate members 110 and, as a result, further improves control of expansion an collapse of the frame during deployment of the implant 20.
  • implants according to the present disclosure may include tension control lines for enhanced control during deployment and implantation. Such delivery and implantation may be further facilitated by corresponding delivery tools configured to modify and control tension applied to the tension control lines and to selectively release the implant when properly positioned.
  • FIG. 13 is a photograph including a delivery tool 300 in accordance with the present disclosure in a disassembled state.
  • the delivery tool 300 generally includes a sheath 302, a release catheter 304, and a tension control assembly 306.
  • An implant 20 including a tension control line 200 is also pictured.
  • the sheath 302 generally forms an exterior of the delivery tool 300 and houses the other components during insertion into the patient.
  • the release catheter 304 is generally disposed within the sheath 302 and the tension control assembly 306 is, in turn, disposed within the release catheter 304.
  • 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 collapsed state within the sheath 302 during initial insertion into the patient.
  • the release catheter 304 is distally extended from the sheath 302, thereby allowing the implant 20 to expand.
  • Subsequent control of expansion and collapse of the implant 20 is facilitate by tension control members 320 extending from the tension control assembly 306, which are coupled to the tension control line 200 of the implant 20 by release lines 350 of the release catheter 304.
  • the release lines 350 are retracted to decouple the tension control members 320 from the tension control line 200, thereby releasing the implant 20.
  • tension control assembly 306 generally includes tension control members 320 that are releasably coupled to the control line 200 of the implant 20.
  • the tension control members 320 may be in the form of cables, control sutures, wires, or similar elongate structures that extend distally from a distal end of a tension control shaft 324.
  • the tension control members 320 may terminate in a loop (e.g., loop 322) or similar structure to facilitate coupling to the tension control members 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 members 320 extending distally out of a catheter body 352 of the release catheter 304.
  • the release catheter 304 includes release lines 350 disposed within and extending through the catheter body 352.
  • the catheter body 352 further defines two sets of lateral holes for facilitating tensioning and release functionality of the delivery tool 300. More specifically, the catheter body 352 defines a set of proximal holes 360 and a set of distal holes 362.
  • the catheter body 352 further defines a distal opening 357.
  • the tension control assembly 306 is generally assembled with the release catheter 304 such that the tension control members 320 extend distally through the proximal holes 360.
  • the release line 350 is slid out of the loop 201, thereby enabling the loop 201 to pass through the loop 322 of the tension control member 320 and decoupling the tension control member 320 from the control line 200.
  • FIGS. 17 and 18 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.
  • routing of the release lines 350 generally includes routing the release lines 350 (shown in dashed lines for clarity and distinction over other illustrated elements) through the catheter body 352 to an exterior thereof, such as by passing the release lines 350 through the distal holes 362 of the catheter body 352.
  • the release lines 350 may then be routed proximally to join the control line 200 to the tension control members 320, as noted above and as illustrated in FIGS. 16-18.
  • the release lines 350 may then be routed proximally and back into the catheter body 352 through the proximal holes 360 where the release lines 350 may be retained, e.g., by friction, until the implant 20 is to be released.
  • FIGS. 20-22 illustrate the general process of releasing the implant 20 from the delivery tool 300.
  • the delivery tool 300 and implant 20 are shown with the frame 55 of the implant 20 in an expanded configuration but still coupled to the delivery tool 300.
  • the implant 20 is coupled to the delivery tool 300 by virtue of the release lines 350 of the release catheter 304, each of which is routed, in order, 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 a loop 321 of one of the tension control members 320, and back into the catheter body 352 through one of the proximal holes 360.
  • the ends 356 of the release lines 350 may be retained within the catheter body 352 by friction.
  • the tension control shaft 324 of the tension control assembly 306 may be actuated (e.g., by translating and/or rotating the shaft or a handle assembly coupled to the shaft) to vary the tension applied to the frame 55 of the implant 20.
  • the frame 55 may be expanded and/or collapsed to facilitate placement of the implant 20 prior to release of the implant 20 from the delivery tool 300.
  • each release line 350 and as indicated by the open arrows such pulling causes the end 356 of the release line 350 to exit the catheter body 352 through one of the proximal holes 360, pass through one of the loops 201 of the tension control line 200 to release the loop 201 from a corresponding control member 320, pass through one of the distal holes 362 of the catheter body 352 and the annular protrusion 51 of the implant 20, and reenter the catheter body 352 through the distal opening 357 of the catheter body 352.
  • pulling the release lines 350 decouples the implant from the delivery tool and allows removal of the delivery tool 300 with the implant 20 remaining in place, as shown in FIG. 22.
  • each of the release catheter 304 and the tension control assembly 306 may be proximally retracted and/or proximally removed from the sheath 302.
  • implementations of implants according to the present disclosure may include an occlusive body supported by a frame with a thin sheet supported by and extending around a proximal portion of the frame.
  • the frame When the implant is deployed within the heart to support function of a heart valve, the frame is supported by an annulus of the valve or by the walls of the atrium such that the occlusive body is disposed to interact with and seal against leaflets of the valve.
  • the thin sheet may be formed from a material that allows for tissue ingrowth such that, over time, the implant is retained more robustly within the heart.
  • 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.
  • inner sheet 2552 and/or outer sheet 2560 may be formed of or include a woven or knit material or fabric that encourages tissue ingrowth.
  • Fabric for inner sheet 2552 and/or outer sheet 2560 may generally have any of the properties or characteristics discussed above with respect to thin sheet 60 of implant 20.
  • outer sheet 2560 the porosity of the fabric may assist in reducing commissural tricuspid regurgitation. Further reduction of commissural tricuspid regurgitation may be provided by the angulation of frame 2555, which provides close contact between outer sheet 2560 and the commissures in a circumferential manner.
  • Frame 2555 may be made from a variety of super-elastic and/or shape memory materials, including, for example, nickel-titanium alloys (e.g., Nitinol), which may be laser cut from a tube or in the form of drawn wire.
  • Nitinol nickel-titanium alloys
  • the features defined in the shape memory materials may be defined therein via various cutting methods known in the art, include laser, waterjet, electrical discharge machining (EDM), stamping, etching, milling, etc.
  • occlusive assembly 2502 and spokes 2595 may be removable after implantation, leaving second annular surface 2564 formed by outer sheet 2560 in place.
  • a circumferential suture connection may exist between spokes 2595 and the rest of frame 2555 radially outward of spokes 2595.
  • this circumferential suture connection may be cut and occlusive assembly 2502 and spokes 2595 may be removed through a catheter, leaving the annular portion of the implant, which then acts as an “annuloplasty” frame.
  • frame 2555 may engage the atrial tissue via the protruding anchor members 2597, which may be in the form of small barbs.
  • Anchor members 2597 are designed to securely engage the atrial tissue without penetrating through the tissue or to the coronary vessels.
  • the protruding anchor members or barbs 2597 may be curved to slide before engaging tissue and there may be one or more rows of protruding anchor members 2597.
  • frame 2555 includes three offset rows of protruding anchor members 2597 with a distal and intermediate row extending through outer sheet 2560 and a proximal row projecting from a distal end of frame 2555. Further details and alternative configurations provided above with respect to protruding anchor members 105 are similarly applicable to anchor members 2597, including implementations in which 2597 are directionally reversed such that they project distally and radially inward.
  • adjacent arcuate petal portions may be joined at or near the vertices along the minor axis, which are generally referred to as co-vertices.
  • arcuate petal portion 2780A and arcuate petal portion 2780B are joined at a junction 2784 disposed distal the co-vertices of arcuate petal portion 2780A and arcuate petal portion 2780B.
  • Proximal frame portion 2759 may similarly include arcuate petal portions that may be ovate, diamond-shaped, or have another elongate shape. Each such arcuate petal portion may be defined by respective major and minor axes.
  • arcuate petal portion 2785A may have a major axis 2786A that extends in a substantially longitudinal direction and a minor axis 27Z7f ⁇ that extends in a circumferential direction.
  • adjacent arcuate petal portions of proximal frame portion 2759 may be joined at or near the vertices along the minor axis (i.e., the co-vertices of the arcuate petal portions).
  • arcuate petal portion 2785A and arcuate petal portion 2785B are joined at a junction 2789 disposed at the corresponding co-vertices of arcuate petal portion 2785A and arcuate petal portion 2785B.
  • frame 2755 may include different numbers of inner and/or outer arcuate petal portions.
  • frame 2755 may include between 10 and 14, between 8 and 16, or between 6 and 18 inner and outer arcuate petal portions.
  • frame 2755 includes 12 each of inner and outer arcuate petal portions with each inner arcuate petal portion joined to a respective outer arcuate petal portion.
  • the number of inner arcuate petal portions may differ from the number of outer arcuate petal portions.
  • frame 2755 may include twice as many inner arcuate petal portions as outer petal portions.
  • each inner arcuate petal portion is unform as is each outer arcuate petal portion.
  • the inner and outer arcuate petal portions may vary in any direction.
  • the inner arcuate petal portions may alternate between arcuate petal portions having a first major axis dimension and arcuate petal portions have a second major axis dimension different than the first major axis dimension.
  • frame 2755 may engage atrial tissue via protruding anchor members, like protruding anchor members 105 of implant 20 or protruding anchor members 2597 or implant 2500, discussed above.
  • implant shape may be varied to accommodate variations in patient anatomy and pathology.
  • an implant configuration in which an occlusive assembly is positioned deeper into the ventricle may be advantageous such that contact and sealing between the occlusive assembly and leaflet occurs earlier in the leaflet’s travel.
  • a more planar or flat implant structure in which the sheets of the implant cover a greater proportion of the tricuspid valve structure may be more advantageous when commissural regurgitation is present despite substantially normal leaflet function.
  • RC-A may be chosen to account for various needs and idiosyncrasies of a particular patient.
  • the proximally concave/distally convex shape illustrated in FIG. 29A generally includes larger and more accessible gaps as compared to the distally concave/proximally convex design illustrated in FIG. 29B and discussed below in further detail.
  • proximally concave implants according to the present disclosure may allow for easier and more accurate placement of other cardiac devices, such as pacemaker leads, though the implant.
  • Proximally concave implants according to this disclosure may also be readily inverted. Such invertibility can facilitate removal of the implant at a later date as the implant can be tunneled and pulled back into a retrieval catheter.
  • implants according to this disclosure having frames formed of metal or other radiopaque materials may further facilitate placement of a pacemaker lead by being visible on fluoroscopy and providing a target for delivering the pacemaker lead.
  • the frame of the implant may also provide constraints for the pacemaker lead to reduce movement of the lead following delivery and implantation. Among other things, such reinforcement of the lead may prevent or reduce the likelihood that the pacemaker lead may obstruct or otherwise interfere with movement of the valve leaflets.
  • Implant 2900B further includes an outer sheet 2914B supported on frame 2908B at proximal end 2904B such that an annular opening 2916B is defined between inner sheet 2912B and outer sheet 2914B.
  • implant 2900B When in the expanded state (e.g., following deployment) implant 2900B has a distally concave shape defined by a radius of curvature (RC-B) such that implant 2900B has an overall funnel-like shape.
  • RC-B radius of curvature
  • Examples of implants with a similar shape include implant 20 and implant 2500, discussed above in further detail.
  • RC-B of implant 2900B may differ in implementations of this disclosure depending on the specific application and needs of the patient.
  • the distally concave design of implant 2900B ensures that initial contact between the valve leaflets and implant 2900B is with occlusive assembly 291 OB as opposed to a portion of frame 2908B, as may occur in the distally concave design of implant 2900A.
  • the distally concave shape reduces the overall size of the implant portion within the ventricle, reducing the likelihood that the implant may obstruct or otherwise interfere with cardiac structures and their respective functions.
  • Implant 2900C includes both proximally and distally concave portions. More specifically, 2900C includes proximal portion 2920C that has a proximally concave shape. Implant 29000 transitions into a distal portion 29220 that has a distally concave shape. In the implementation illustrated in FIG. 29C, distal portion 29220 further transitions into a proximally concave cap portion 2924C that includes occlusive assembly 2910C and, more specifically, inner sheet 2912C. In other implementations, distal portion 2922C may instead terminate in an occlusive body, such as central occluder 50 of implant 20 or central occlusive body 2550 of implant 2500.
  • occlusive body such as central occluder 50 of implant 20 or central occlusive body 2550 of implant 2500.
  • the shape of implant 2900C may be defined by at least two radii of curvature. More specifically, the shape of implant 2900C may be defined by a radius of curvature (RC-C) corresponding to proximal portion 2920C (i.e., the proximally concave portion of implant 2900C) and a radius of curvature (RC-D) corresponding to the distal portion 2922C (i.e., the distally concave portion of implant 2900C).
  • RC-C radius of curvature
  • RC-D radius of curvature
  • implant 2900C may be further defined by a radius of curvature (RC-E) corresponding to proximally concave cap portion 2924C.
  • RC-E and RC-C may be the same; however RC-E and RC-C may also differ such that proximally concave cap portion 2924C may have a more or less pronounced curvature than proximal portion 2920C.
  • FIGS. 30A and 30B are views of an implant 3000A having a conical shape when deployed while FIG. 30B is an elevation view of an implant 3000B having a flat or planar shape when deployed.
  • FIGS. 29A and 29B for clarity and simplicity, each of implant 3000A and implant 3000B are shown in a simplified view in which overall shape is emphasized and certain elements of each implant are omitted. Accordingly, and unless stated otherwise, implant 3000A and implant 3000B may generally include elements of and be in accordance with any other implementation discussed herein.
  • implant 3000A includes a distal end 3002A and a proximal end 3004A such that a longitudinal axis 3006A of implant 3000A extends between distal end 3002A and proximal end 3004A.
  • Implant 3000A includes a frame 3008A that supports an occlusive assembly 3010A at distal end 3002A.
  • occlusive assembly 3010A includes an inner sheet 3012A and an occlusive body 3013A.
  • occlusive assembly 3010A may instead include only one of inner sheet 3012A and occlusive body 3013A.
  • Implant 3000A further includes an outer sheet 3014A supported on a proximal portion of frame 3008A such that an annular opening 3016A is defined between inner sheet 3012A and outer sheet 3014A.
  • FIG. 30A shows implant 3000 in the expanded state (e.g., following deployment). As shown and in contrast to the curved funnel shape of implant 2900B, implant 3000A has a straight-sided funnel shape. Stated differently, when deployed, implant 3000A has a distally expanding conical or frustoconical shape.
  • implant 3000A may be modified to vary the degree to which occlusive assembly 3010A enters the ventricle when implant 3000A is deployed within the heart.
  • the general shape of implant 3000B may be determined by an angle 0, which may be defined as the angle between the sides of frame 3008A and longitudinal axis 3006A of implant 3000A when implant 3000A is in the expanded/deployed state.
  • angle 0 may be defined as the angle between the sides of frame 3008A and longitudinal axis 3006A of implant 3000A when implant 3000A is in the expanded/deployed state.
  • varying 0 changes overall length of implant 3000A when expanded and, as a result, the depth of occlusive assembly 301 OA within the ventricle.
  • reducing 0 increases the overall length of implant 3000A and the depth of occlusive assembly 301 OA within the ventricle when implant 3000A is deployed. Conversely, increasing 0 reduces the overall length of implant 3000A when deployed (e.g., results in implant 3000A being more planar in the expanded state) and the depth of occlusive assembly 301 OA within the ventricle.
  • implant 3000B expands into a flat or planar shape when deployed.
  • Implant 3000B includes a radially inward portion 3002B and a radially outward portion 3004B relative to a longitudinal axis 3006B.
  • radially inward portion 3002B forms a distal or leading end of implant 3000B while radially outward portion 3004B forms a proximal end of implant 3000B.
  • implant 3000B includes a frame 3008B that supports an occlusive assembly 3010B at radially inward portion 3002B.
  • occlusive assembly 301 OB includes an inner sheet 3012B.
  • occlusive assembly 3010B may further or alternatively include an occlusive body 3013B, which FIG. 30B shows in dashed lines.
  • Implant 3000B further includes an outer sheet 3014B supported on a proximal portion of frame 3008B such that an annular opening 3016B is defined between inner sheet 3012A and outer sheet 3014B.
  • Planar implants such as implant 3000B, may be particularly advantageous in cases where regurgitation results despite substantially normal valve leaflet travel.
  • implant 3000B When deployed, implant 3000B may be positioned along the floor of the atrium across the valve annulus with occlusive assembly 3010B centrally located or approximately centrally located.
  • occlusive assembly 3010B includes occlusive body 3013B
  • occlusive body 3013B may project into the valve annulus or across the valve annulus into the ventricle, depending on its size and shape.
  • frames of implants according to this disclosure are configured to be expandable about a longitudinal axis of the implant. More specifically, frames of implants according to the present disclosure are configured to transition between a collapsed state and an expanded state.
  • the collapsed state may correspond, for example, to a 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 of which is discussed above in detail.
  • the expanded state may correspond to a state of the implant following delivery and deployment within a patient heart.
  • Implant frames according to this disclosure may be biased into the expanded state such that the implant transitions into the expanded state absent resistance provided by a delivery tool.
  • frame 3108 of implant 3100 includes a distal frame portion 3118 including a first set of circumferentially distributed arcuate petal portions, such as arcuate petal portion 3120A and arcuate petal portion 3120B, and a proximal frame portion 3138 including a second set of circumferentially distributed arcuate petal portions, such as arcuate petal portion 3140A and arcuate petal portion 3140B.
  • arcuate petals portions according to this disclosure may be ovate, diamond-shaped, or have any similar elongate shape (e.g., generally diamond shaped albeit with rounded vertices or curved edges). More generally, arcuate petal portions according to this disclosure may have any suitable shape that enables collapsing and expanding of the frame and other functionality described herein (e.g., support of fabric sheets, such as inner sheet 3112 and outer sheet 3114).
  • Arcuate petal portions of distal frame portion 3118 may be joined to respective arcuate petal portions of proximal frame portion 3138.
  • arcuate petal portion 3120A is coupled to arcuate petal portion 3140A by a longitudinal member 3148 extending between a proximal vertex 3125 of arcuate petal portion 3120A and a distal vertex 3145 of arcuate petal portion 3140A.
  • longitudinal member 3148 extending between arcuate petal portion 3120A and arcuate petal portion 3140A is substantially longer than longitudinal member 2790 extending between arcuate petal portion 2780A and arcuate petal portion 2785A of implant 2700 (shown in FIG. 28).
  • longitudinal members may extend between the junctions of the first set of arcuate petal portions (e.g., junction 3126) and the junctions of the second set of arcuate petal portions (e.g., junction 3146).
  • the first set of arcuate petal portions can be rotationally offset from the second set of arcuate petal portions such that the junctions of one set align with the vertices of the other set.
  • longitudinal members may extend between the junctions of one set and the vertices of the other.
  • longitudinal members may extend between junctions of the first set of arcuate petal portions (e.g., junction 3126) and the distal vertices of the second set of arcuate petal portions (e.g., distal vertex 3145).
  • longitudinal members may extend between the proximal vertices of the first set of arcuate petal portions (e.g., proximal vertex 3125) and the junctions of the second set of arcuate petal portions (e.g., junction 3146).
  • either of the inner sheet or the outer sheet may define one or more internal pockets.
  • the sheet may include two or more layers stitched or otherwise coupled together to form internal pockets between adjacent layers.
  • the adjacent layers may include a first layer disposed on a proximal or inner surface of the implant frame and a second layer disposed on a distal or outer surface of the implant frame such that the frame also extends between the layers.
  • the layers forming the internal pockets may be disposed entirely on the proximal/inner surface of the frame or the distal/outer surface of the frame.
  • occlusive assembly 3210 includes an inner sheet 3212; however, in other implementations, occlusive assembly 3210 may include an occlusive body instead of or in addition to inner sheet 3212.
  • Implant 3200 further includes an outer sheet 3214 supported on a proximal portion of frame 3208 such that an annular opening 3216 is defined between inner sheet 3212 and outer sheet 3214.
  • each longitudinal member extends from a respective junction of the first set of arcuate petal portions.
  • longitudinal member 3248A extends from a junction 3226 between arcuate petal portion 3220A and arcuate petal portion 3220B.
  • the first and second set of arcuate petal portions of implant 3200 may be rotationally offset from the configuration illustrated in FIG. 32 such that the longitudinal members instead extend from proximal vertices (e.g., proximal vertex 3125) of the first set of arcuate petal portions.
  • longitudinal member 3348A and longitudinal member 3348B extend from respective junctions of the first set of arcuate petal portions.
  • longitudinal member 3348A extends from a junction formed between arcuate petal portion 3320A and arcuate petal portion 3320B.
  • the first and second set of arcuate petal portions of implant 3300 may be rotationally offset from the configuration illustrated in FIG. 33 such that the longitudinal members instead extend from proximal vertices (e g., proximal vertex 3325) of the first set of arcuate petal portions.
  • arcuate petal portions contributes to the overall length of the implant when in the collapsed state.
  • an arcuate petal portion When an arcuate petal portion is collapsed (e.g., when the implant is in the collapsed state), the arcuate petal portion undergoes each of circumferential compression and longitudinal elongation.
  • a first implant with more and/or larger arcuate petal portions than a second implant will typically have a longer collapsed length than the second implant even when the first and second implants have the same overall dimensions when in their respective expanded states.
  • an implant frame with a higher proportion of longitudinal members and a lower proportion of arcuate petal portions may be selected in implementations in which cardiac tissue may be damaged by higher radial forces or that may require the implant to conform to more complex geometry within the heart.
  • FIG. 34 illustrates an implant 3400 having a frame configuration similar to that of implant 3300 of FIG. 33.
  • Implant 3400 includes a distal end 3402 and a proximal end 3404 such that a longitudinal axis 3406 of implant 3400 extends between distal end 3402 and proximal end 3404.
  • Implant 3400 includes a frame 3408 that may support an occlusive assembly at distal end 3302.
  • FIG. 34 omits the occlusive assembly to show the various features and configuration of frame 3408 more clearly.
  • the occlusive assembly may include an occlusive body and/ or an inner sheet.
  • Implant 3400 may also include an outer sheet (not shown in FIG. 34) supported on a proximal portion of frame 3408 such that an annular opening is defined between the inner sheet/occlusive assembly and the outer sheet.
  • Frame 3408 of implant 3400 includes a distal frame portion 3418 including a set of circumferentially distributed arcuate petal portions, such as arcuate petal portion 3420A and arcuate petal portion 3420B.
  • Frame 3408 further includes a proximal frame portion 3438 including a second set of circumferentially distributed arcuate petal portions, such as arcuate petal portion 3440A and arcuate petal portion 3440B.
  • Each arcuate petal portion of the second set of arcuate petal portions of implant 3400 is formed by arcuate frame members extending between longitudinal members.
  • arcuate petal portion 3440A is formed by arcuate frame member 3441 A and arcuate frame member 3441 B, which extend between longitudinal member 3448A and longitudinal member 3448B.
  • Longitudinal member 3348A and longitudinal member 3348B extend from respective proximal tips of arcuate petal portions of the first set of arcuate petal portions, e.g., longitudinal member 3448A extends from a proximal tip 3426 of arcuate petal portion 3420A.
  • implant 3400 of FIG. 34 has varying concavity, like implant 2900C of FIG. 29C. More specifically, implant 3400 includes each of a proximal portion 3450 that is proximally concave, a distal portion 3452 that is distally concave, and a cap portion 3454 that is proximally concave.
  • Implant 3400 further includes circumferentially distributed anchor members, 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 a proximal tip of a respective arcuate frame member. Specifically, each anchor member of the first set of anchor members extends from a proximal tip of the distal frame member of each arcuate petal portion. So, for example, anchor member 3456 extends from the proximal tip of arcuate frame member 3441 B.
  • Anchor member 3458 is part of a second set of anchor members that extend radially outward from junctions between arcuate tip members and longitudinal members.
  • each anchor member of the second set of anchor members extends from a respective junction between the proximal frame member of each arcuate petal portion and each longitudinal member.
  • anchor member 3458 extends from the junction between arcuate frame member 3441 A and longitudinal member 3348A.
  • anchor members may alternatively or additional be disposed at other locations of the frame including, but not limited, to the proximal tip of the proximal arcuate frame member (e.g., arcuate frame member 3441 A) and the junctions formed between the distal arcuate frame members and the longitudinal members.
  • Frame 3508 of implant 3500 includes a distal frame portion 3518 including a set of circumferentially distributed arcuate petal portions, such as arcuate petal portion 3520A and arcuate petal portion 3520B (each labelled in FIG. 35A).
  • Frame 3508 further includes an intermediate frame portion 3538 including a second set of circumferentially distributed arcuate petal portions, such as arcuate petal portion 3540A and arcuate petal portion 3540B (each labelled in FIG. 35A) and a proximal frame portion 3558 including a third set of circumferentially distributed arcuate petal portions, such as arcuate petal portion 3560A and arcuate petal portion 3560B (each labelled in FIG. 35A).
  • implant 3500 of FIGS. 35A and 35B has varying concavity. More specifically, implant 3500 includes each of a proximal portion 3550 that is proximally concave, a distal portion 3552 that is distally concave, and a cap portion 3554 that is proximally concave. [0298] Also, like 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 portions of the third set of arcuate petal portions.
  • anchor member 3556 extends from a junction 3564 between arcuate petal portion 3560A and arcuate petal portion 3560B.
  • anchor members may alternatively or additional be disposed at other locations of the frame including, but not limited, junctions between adjacent arcuate petal portions of the second set of arcuate petal portions and the proximal tips of the arcuate petal portions of the third set of arcuate petal portions.
  • the overall height of implant 3500 in the expanded state may vary; however, in at least certain implementations, the overall height of implant 3500 may be from and including about 26 mm to and including about 48 mm and, in one specific implementation, may be 36 mm.
  • anchor members e.g., protruding anchor members 105 of frame 55
  • anchor members may be added to or otherwise included in any implant design discussed herein.
  • this disclosure discusses control of implant expansion by a tension control line in the context of FIGS. 12-22, such functionality may be adapted to and included in any other implant discussed herein.
  • valve repair implant 3800 is releasably coupled to a control arm assembly 3608 of delivery device 3600.
  • the control arm assembly can be manipulated to expand laterally or collapse medially relative to a longitudinal axis 3603 of delivery device 3600. Due to the coupling of the control arm assembly 3608 to valve repair implant 3800, such expansion and collapse of the control arm assembly 3608 results in corresponding expansion and collapse of valve repair implant 3800.
  • valve repair implant 3800 may be coupled to delivery device 3600 by a cinch line 3614 (shown in FIGS. 37 and 38).
  • cinch line 3614 forms a loop that extends distally from delivery catheter 3604 and routes through loops, rings, apertures, or similar features of each of the control arm assembly 3608 and valve repair implant 3800 to couple valve repair implant 3800 to the control arm assembly 3608.
  • cinch line 3614 facilitates accurate control of expansion and collapse of valve repair implant 3800 during deployment and implantation.
  • cinch line 3614 may be selectively tensioned during to encourage uniform expansion and collapse of valve repair implant 3800.
  • FIG. 39 shows delivery device 3600 with delivery catheter 3604 and a sheath 3616 (shown in FIG. 38) removed.
  • delivery catheter 3604 may be capped with a tip or a collar 3618 through which various components of delivery device 3600 may extend.
  • each of extension member 3606 and control arm assemblies e.g., control arm assembly 3608 extend through collar 3618, which supports and maintains relative positioning of components of delivery device 3600, such as extension member 3606 and control arm assembly 3608.
  • FIGS. 42 and 43 illustrate delivery device 3600 with distal tube 3626 removed.
  • FIG. 42 illustrates delivery device 3600 with control arm assembly 3608 in a collapsed state
  • FIG. 43 illustrates delivery device 3600 with control arm assembly 3608 in an expanded state.
  • control arm assembly 3608 may include a proximal portion 3630 including a proximal collar 3632 from which multiple proximal arms (e.g., proximal arm 3634) extend.
  • Delivery device 3600 further includes a distal cap 3638 from which multiple distal arms (e.g., distal arm 3640) of control arm assembly 3608 extend.
  • each of the distal arms forms a control arm pair with a respective one of the proximal arms and each control arm pair may be moved between an expanded and collapsed state by actuating control arm assembly 3608.
  • actuation of control arm assembly 3608 includes proximally driving or distally retracting proximal portion 3630 using a control arm shaft 3642, which may be coupled to a control assembly of delivery device 3600, the control assembly including suitable controls for selectively translating control arm shaft 3642.
  • FIG. 44 illustrates delivery device 3600 with control arm assembly 3608 removed.
  • delivery device 3600 may include an extension member control rod 3644 that extends through delivery catheter 3604 and couples to extension member 3606 to facilitate extension and retraction of extension member 3606 relative to delivery catheter 3604.
  • a proximal end of extension member control rod 3644 may be coupled to a control assembly at a proximal end of delivery catheter 3604, the control assembly including a control element for selectively translating extension member control rod 3644.
  • valve repair system 1100 illustrated in FIGS. 11A-11C includes catheter 1177, which may be inserted into a patient via sheath 1176 and subsequently steered using steering control 1180. More specifically, catheter 1177 is illustrated and discussed as being steerable along a single plane between two extents, generally illustrated by dashed outlines 1192A and dashed outlines 1192B. Accordingly, the implementation illustrated in FIGS. 11A-11C provides a single degree of freedom for steering catheter 1177.
  • Other implementations of this disclosure may include an alternative delivery catheter configuration that provides multiple degrees of freedom.
  • delivery tools according to this disclosure may be divided into multiple segments, each of which may be steerable along one or more planes.
  • Such increased maneuverability facilitates navigation of the delivery tool to an implant location and final placement of the valve repair implant, among other benefits, ultimately resulting in faster, more efficient, and more accurate implantation procedures.
  • FIG. 45A is a side view of delivery device 3600 with an external sheath removed and implant 3800 in a deployed and expanded configuration.
  • Delivery device 3600 includes delivery catheter 3604, which, in certain implementations, may be a steerable catheter.
  • delivery device 3600 includes each of a distal steerable section 4502 and a proximal steerable section 4504, each of which may steered independently from a control assembly (not shown) coupled to a proximal end of delivery catheter 3604.
  • distal steerable section 4502 may be configured to bend along a plane 4506.
  • the control assembly coupled to delivery catheter 3604 may include a knob, lever, arm, or similar control element attached to distal steerable section 4502 by a cable, wire, or similar control line such that manipulating the control element bends distal steerable section 4502 across a range of motion along plane 4506.
  • distal steerable section 4502 may be configured to have a minimum bend radius along plane 4506 from and including about 10 mm to and including about 20 mm and in one specific implementation may have a minimum bending radius of about 15 mm.
  • the control assembly may further include a mechanism (e.g., a knob, slide, button, etc.) for locking the angle of distal steerable section 4502.
  • Proximal steerable section 4504 may be configured to bend along a plane 4508 that is coplanar to plane 4506 when delivery device 3600 is in a neutral/straight configuration.
  • proximal steerable section 4504 may also be independently steerable along a second plane, such as plane 4510.
  • plane 4510 may be orthogonal to plane 4508.
  • the control assembly coupled to delivery catheter 3604 may include a respective knob, lever, arm, or similar control element for each degree of freedom of proximal steerable section 4504.
  • FIGS. 45B-45H further illustrate steering of delivery device 3600.
  • FIG. 45B and 45C illustrate steering of distal steerable section 4502 of delivery device 3600. More specifically, FIG. 45B illustrates distal steerable section 4502 in a substantial neutral position while FIG. 45C illustrates steering of distal steerable section 4502 to a first extent along plane 4506 (shown in FIG. 45A).
  • distal steerable section 4502 may be steerable along plane 4506 by approximately 135 degrees; however, this disclosure is not limited to any specific bending angle of distal steerable section 4502.
  • distal steerable section 4502 may be configured to bend up to 180 degrees or more in a given direction.
  • FIG. 45C illustrates steering of distal steerable section 4502 in a first direction
  • distal steerable section 4502 may be bidirectionally steerable from the neutral state shown in FIG. 45B.
  • distal steerable section 4502 may be steerable through approximately 360 degrees of bending along plane 4506.
  • steering of distal steerable section 4502 as illustrated in FIGS. 45B and 45C may be particularly useful in achieving orthogonality between a longitudinal axis of the implant being and/or distal steerable section 4502 and the valve annulus. More specifically, during delivery of the implant to the right atrium, a clinician generally directs delivery device 3600 into the right atrium via the inferior vena cava with delivery device 3600 in the neutral state illustrated in FIG. 45B. Following entry into the right atrium, the clinician may steer distal steerable section 4502 to achieve and maintain substantial orthogonality of distal steerable section 4502 and the implant with the tricuspid valve annulus until delivery of the implant is complete.
  • FIGS. 45D and 45E illustrate steering of proximal steerable section 4504 of delivery device 3600. More specifically, FIG. 45D illustrates proximal steerable section 4504 in a substantial neutral position while FIG. 45E illustrates proximal steerable section 4504 following bending along plane 4508 (shown in FIG. 45A). As shown in FIG. 45A, plane 4506 and plane 4508 are coplanar when delivery device 3600 is in a neutral state.
  • FIG. 45E illustrates how, in at least certain implementations, proximal steerable section 4504 may be steerable along plane 4508 by approximately 45 degrees; however, this disclosure is not limited to any specific bending angle of proximal steerable section 4504 along plane 4508.
  • proximal steerable section 4504 may be configured to bend up to 60 degrees or more in a given direction along plane 4508.
  • proximal steerable section 4504 may be bidirectionally steerable along plane 4508.
  • the bending radius of proximal steerable section 4504 along plane 4508 may be from and including about 5 cm to and including about 7 cm, for example approximately 6 cm; however, this disclosure is not limited to any particular bending radius for proximal steerable section 4504 along plane 4508.
  • proximal steerable section 4504 along plane 4508 may be particularly useful in controlling the height/insertion of the implant and distal steerable section 4502 relative to the valve annulus and for maximizing use of the atrial volume to properly align the implant with the valve annulus.
  • distal steerable section 4502 may be oriented such that proximal steerable section 4504 and/or distal steerable section 4502 extend in a partially lateral direction toward the atrial septum.
  • proximal steerable section 4504 may be steered as shown in FIG. 45E such that proximal steerable section 4504 is maintained near or along the medial surface of the right atrium, thereby increasing the volume of the right atrium available within which distal steerable section 4502 may be steered and manipulated.
  • FIGS. 45F-45H illustrate steering of proximal steerable section 4504 of delivery device 3600. More specifically, FIG. 45F illustrates proximal steerable section 4504 in a substantial neutral position while FIG. 45G illustrates proximal steerable section 4504 following bending along plane 4510 (shown in FIG. 45A). As shown in FIG. 45A, plane 4510 is orthogonal to each of plane 4506 and plane 4508 are coplanar when delivery device 3600 is in a neutral state. [0326] FIG. 45G illustrates proximal steerable section 4504 bent along plane 4510 in a first direction from the neutral state illustrated in FIG. 45F while FIG.
  • proximal steerable section 4504 bent along plane 4510 in a second direction from the neutral state and opposite the first direction.
  • bending of proximal steerable section 4504 along plane 4510 is up to approximately 30 degrees in either direction; however, this disclosure is not limited to any specific bending angle of proximal steerable section 4504 along plane 4508. More generally, in certain implementations, proximal steerable section 4504 may be configured to bend up to about 60 degrees or more in one or both directions relative to neutral along plane 4510.
  • FIGS. 46-49 are photographs of a portion of a steering control assembly 4600 for delivery device 3600 and, in particular, a portion of steering control assembly 4600 including steering controls.
  • steering control assembly 4600 may be coupled to a proximal end of delivery catheter 3604.
  • FIG. 46 is an elevation view of steering control assembly 4600, which includes a first steering portion 4602, a second steering portion 4604, and a third steering portion 4606.
  • the functions of each steering portion are described below in further detail; however, in the specific implementation illustrated in FIGS. 46-49, the first, second, and third steering portions generally correspond to a “primary” steering mechanism, a “depth” steering mechanism, and an “offset” steering mechanism, as labelled in the figures and as described below in further detail.
  • FIG. 47 is a detailed view of first steering portion 4602, which is also referred to in this disclosure as the primary steering mechanism.
  • first steering portion 4602 may control steering/bending of distal steerable section 4502 along plane 4506. In at least certain implementations, such movement corresponds to medial and lateral steering movement at the distal end of delivery catheter 3604.
  • first steering portion 4602 may include a steering lever 4608 or that can be manipulated to steer distal steerable section 4502 and a locking knob 4610 for locking the position of steering lever 4608 and, as a result, the direction of distal steerable section 4502 across plane 4506.
  • FIG. 48 is a detailed view of second steering portion 4604, which is also referred to in this disclosure as the depth steering mechanism.
  • second steering portion 4604 may control steering/bending of proximal steerable section 4504 along plane 4508, which is coplanar to plane 4506 (i.e. , the plane of movement for distal steerable section 4502) when delivery catheter 3604 is in a neutral configuration.
  • plane 4506 i.e. , the plane of movement for distal steerable section 4502
  • such movement corresponds to superior and inferior steering movement at the distal end of delivery catheter 3604. As illustrated in FIG.
  • second steering portion 4604 may include a steering lever 4612 that can be manipulated to steer proximal steerable section 4504 and a locking knob 4614 for locking the position of steering lever 4612 and, as a result, the direction of proximal steerable section 4504 across plane 4508.
  • FIG. 49 is a detailed view of third steering portion 4606, which is also referred to in this disclosure as the offset steering mechanism.
  • third steering portion 4606 may control steering/bending of proximal steerable section 4504 along plane 4510, which is orthogonal to plane 4508. In at least certain implementations, such movement corresponds to posterior and anterior steering movement at the distal end of delivery catheter 3604.
  • first steering portion 4602 may include a steering lever 4616 that can be manipulated to steer proximal steerable section 4504 and a locking knob 4618 for locking the position of steering lever 4616 and, as a result, the direction of proximal steerable section 4504 across plane 4510.
  • implant 3800 is coupled to a distal end of delivery device 3600 and, more specifically to a distal end of delivery catheter 3604 of delivery device 3600.
  • delivery device 3600 may include a sheath that extends along an exterior surface of delivery catheter 3604.
  • FIG. 50 for example, is a photograph of delivery device 3600 including a sheath 3616 disposed over delivery catheter 3604 and implant 3800.
  • sheath 3616 is translatable relative to delivery catheter 3604.
  • sheath 3616 may be translatable from an extended configuration to a retracted configuration.
  • sheath 3616 may extend sufficiently beyond a distal end of delivery catheter 3604 to cover and at least partially contain implant 3800.
  • sheath 3616 may be retracted, thereby permitting deployment of implant 3800.
  • sheath 3616 may also be configured to be distally re-extended following deployment and release of implant 3800. Among other things, such re-extension of sheath 3616 enables sheathing of the distal portion of delivery device 3600 for retraction and removal from the patient.
  • FIG. 52 and 53 are photographs of a portion of a sheath control assembly 5200 illustrating an example implementation of sheath controls that may be used in conjunction with delivery device 3600.
  • Sheath control assembly 5200 includes a knob 5202 which can be rotated to extend and retract sheath 3616; however, knob 5202 may be substituted with a lever, slide, or similar control element in other implementations.
  • sheath control assembly 5200 may further include a flush port 5204 in communication with an internal volume of sheath 3616 to facilitate flushing of sheath 3616.
  • Sheath control assembly 5200 may further include a window 5206 and indicators 5208 or similar markings to communicate the position of sheath 3616.
  • sheath 3616 may be visible through window 5206 and indicators 5208 may be in the form of lines, grooves, marks, etc. disposed adjacent window 5206 with which the proximal end of sheath 3616 may align to indicate the position of sheath 3616.
  • sheath 3616 and sheath control assembly 5200 may be configured to permit from and including about 5 cm to and including about 12 cm of travel.
  • sheath 3616 may be retractable up to 8 cm from a fully extended configuration.
  • sheath control assembly 5200 does not include a locking mechanism for locking the position of sheath 3616; however, in other implementations, sheath control assembly 5200 may include a locking mechanism (e.g., a knob, clamp, pin, etc.) for locking the position of sheath 3616, e.g., by positively engaging a portion of sheath 3616 within sheath control assembly 5200 or by preventing manipulation of the control element of sheath control assembly 5200 for extending and retracting sheath 3616.
  • a locking mechanism e.g., a knob, clamp, pin, etc.
  • delivery devices may include a mechanism for extending implant 3800 from delivery catheter 3604 to a first extent for deployment. Following deployment, the mechanism may enable at least partial de- extension/retraction of implant 3800 to reduce the overall combined length of distal portion 3602 of delivery device 3600 and implant 3800. Given the confined space of the atria, such reduction in the combined length of delivery device 3600 and implant 3800 can provide substantially increased maneuverability and control of delivery device 3600 and implant 3800, leading to faster and more accurate implant placement.
  • extension and de-extension/retraction of implant 3800 relative to delivery catheter 3604 may be achieved by extending and retracting extension member 3606 relative to delivery catheter 3604.
  • extension member 3606 extends distally from delivery catheter 3604 and supports the distal control arms of the control arm assemblies.
  • implant 3800 is attached to delivery device 3600 by coupling implant 3800 to the control arm assemblies. Accordingly, given that the control arm assemblies are coupled to extension member 3606, extension and retraction of extension member 3606 relative to delivery catheter 3604 also results in extension and retraction of implant 3800 relative to delivery catheter 3604 when implant 3800 is attached to delivery device 3600.
  • FIGS. 54A and 54B are photographs of delivery device 3600 with implant 3800 attached.
  • FIG. 54A illustrates delivery device 3600 and implant 3800 in a fully extended configuration.
  • the fully extended configuration may be used to facilitate initial deployment of implant 3800, e.g., by fully clearing implant 3800 from sheath 3616 (not shown) and delivery catheter 3604.
  • delivery device 3600 may be actuated to distally extend extension member 3606 relative to delivery catheter 3604, thereby enabling deployment and expansion of implant 3800.
  • extension member 3606 may be at least partially retracted relative to delivery catheter 3604, resulting in the retracted/de-extended configuration of FIG. 45B.
  • extension member 3606 may be configured to undergo from and including about 15 mm to and including about 25 mm of travel relative to delivery catheter 3604 with possible retraction/de-extension from and including about 50% to and including about 80% of the total travel distance of extension member 3606.
  • extension member 3606 may be configured to have approximately 20 mm of total travel with at least 12 mm of retraction/de-extension available following deployment of implant 3800.
  • FIG. 55 is a photograph of a portion of a deployment control assembly 5500 illustrating an example implementation of extension/de-extension controls that may be used in conjunction with delivery device 3600.
  • Deployment control assembly 5500 includes an extension handle 5502 which can be rotated to extend and retract extension member 3606; however, extension handle 5502 may be substituted with a lever, slide, knob, or similar control element in other implementations.
  • each proximal arm is coupled to a proximal portion of its respective distal arm such that the distal arm similarly extends in a lateral/medial direction based on the degree of extension of the proximal arm.
  • the distal arm generally provides support and stability to the proximal arm; however, in certain implementations, the proximal portion of the distal arm may also include a ring, a loop, an aperture, or similar feature through which cinch line 3614 may pass to couple implant 3800 to delivery device 3600.
  • FIG. 56 and 57 illustrate distal portion 3602 of delivery device 3600 with control arm assembly 3608 in a collapsed and expanded state, respectively.
  • the following discussion describes operation of control arm assembly 3608 by referring primarily to proximal arm 3634 and distal arm 3640. Such references are intended for clarity and conciseness only. Unless otherwise specified, references to proximal arm 3634 and distal arm 3640 should be considered to apply generally to the other proximal and distal arms of control arm assembly 3608.
  • proximal arm 3634 and distal arm 3640 lie substantially flat and parallel to longitudinal axis 3603 of delivery device 3600.
  • control arm assembly 3608 is expanded, e.g., by pushing proximal portion 3630 of control arm assembly 3608 with control arm shaft 3642 as discussed in the context of FIGS. 42 and 43, distal portion 3636 of proximal arm 3634 travels in a partially lateral direction.
  • lateral travel of distal portion 3636 results from proximal arm 3634 having a shape or being biased in an outwardly curved direction.
  • delivery device 3600 may include a diverter or similar structural element (such as diverter 3628 illustrated in FIG. 41) that directs proximal arm 3634 in a lateral direction as proximal arm 3634 extends from delivery catheter 3604, as shown in FIG. 57.
  • distal portion 3636 of proximal arm 3634 Due to the coupling of distal portion 3636 of proximal arm 3634 with a proximal portion 3641 of distal arm 3640, extension of proximal arm 3634 from delivery catheter 3604 applies a lateral force to proximal portion 3641 of distal arm 3640.
  • a distal portion 3643 of distal arm 3640 is fixed to distal cap 3638 of extension member 3606. Accordingly, as a lateral force is applied to proximal portion 3641 of distal arm 3640, distal portion 3643 of distal arm 3640 bends outwardly.
  • distal arm 3640 may instead be coupled to distal cap 3638 by a hinge or similar movable joint that permits lateral movement of proximal portion 3641 of distal arm 3640 without substantial bending.
  • Collapse of control arm assembly 3608 may be achieved by retracting proximal portion 3630 of control arm assembly 3608, which in turn causes retraction of proximal arm 3634 into delivery catheter 3604. Due again to the coupling of distal portion 3636 of proximal arm 3634 with a proximal portion 3641 of distal arm 3640, retraction of proximal arm 3634 into delivery catheter 3604 applies a medial force to proximal portion 3641 or distal arm 3640, thereby causing distal arm 3640 to return to a collapsed configuration.
  • FIG. 58 illustrates an example coupling arrangement of proximal arm 3634 with distal arm 3640 in further detail.
  • distal portion 3636 of proximal arm 3634 may include a first feature, e.g., a protrusion 3637, shaped to be inserted into and retained by a second feature, e.g., an aperture 3639 of distal arm 3640.
  • a first feature e.g., a protrusion 3637
  • FIG. 58 shows protrusion 3637 as being T-, dogbone-, or barbell-shaped and aperture 3639 as an ovate slot. Accordingly, protrusion 3637 may be rotated 90 degrees, inserted through aperture 3639, and unrotated to cause protrusion 3637 to be retained by aperture 3639 and coupling distal portion 3636 to distal arm 3640.
  • the protrusion and aperture may be reversed such that a protrusion of distal arm 3640 extends through and is retained by an aperture of proximal arm 3634.
  • This disclosure contemplates other coupling arrangements of proximal arm 3634 with distal arm 3640 and notes that any coupling that permits the necessary movement of proximal arm 3634 relative to distal arm 3640 for expansion of control arm assembly 3608 may be used instead of the specific coupling arrangement illustrated in FIG. 58.
  • FIG. 59 is a detailed view of coupling between control arm assembly 3608 and implant 3800.
  • coupling of delivery device 3600 to implant 3800 is by cinch line 3614, which forms a loop through delivery device 3600 and about an inner circumference of implant 3800. More specifically, cinch line 3614 extends through delivery catheter 3604 (e.g., through cinch line tube 3620). Cinch line 3614 is then routed through apertures extending around each of control arm assembly 3608 and implant 3800. Cinch line 3614 is then rerouted back through delivery catheter 3604 (e.g., through cinch line tube 3622) to a proximal end of delivery catheter 3604.
  • delivery catheter 3604 e.g., through cinch line tube 3622
  • the apertures of implant 3800 may be in the form of hoops, loops, or rings (e.g., ring 3804) extending around an inner surface 3802 of implant 3800.
  • the apertures of control arm assembly 3608 may similarly be in the form of hoops, loops, or rings (e.g., ring 3646) coupled to control arm assembly 3608.
  • ring 3646 is attached to and extends from proximal portion 3641 of distal arm 3640.
  • distal arm 3640 or distal portion 3636 may define and include an integrally formed hole, port, or similar opening that functions as the aperture through which cinch line 3614 extends.
  • implant 3800 can be coupled to delivery device 3600. Additionally, such an arrangement also enables cinch line 3614 to provide additional control and uniformity when expanding and collapsing implant 3800 during deployment and implantation. For example, given that cinch line 3614 extends around the circumference of implant 3800, applying tension to cinch line 3614 results in a distributed medial pulling force about implant 3800. As implant 3800 is collapsed, this distributed medial force encourages implant 3800 to collapse uniformly, thereby improving control and predictability during collapse of implant 3800. The distributed medial force may also act as a counterforce when expanding implant 3800, which, again, encourages implant 3800 to expand uniformly and improving control and predictability of implant expansion.
  • delivery device 3600 may include a control assembly including control elements for adjusting expansion and collapse of control arm assembly 3608 and operation of cinch line 3614.
  • deployment control assembly 5500 includes an expansion handle 5504 that can be rotated to selectively expand and collapse implant 3800 when implant 3800 is coupled to control arm assembly 3608.
  • rotation of expansion handle 5504 may translate control arm shaft 3642 relative to delivery catheter 3604.
  • expansion handle 5504 may be replaced with other control elements, such as a lever, knob, or similar component for selectively translating control arm shaft 3642 relative to delivery catheter 3604.
  • Deployment control assembly 5500 further includes a tensioner 5506 for controlling tension on cinch line 3614.
  • tensioner 5506 couples to a first end of cinch line 3614 while a second end of cinch line 3614 may be fixed at another point on deployment control assembly 5500.
  • Tensioner 5506 may be selectively movable, e.g., along a rail 5508, such that by proximally translating tensioner 5506, tension on cinch line 3614 can be increased. Conversely, by distally translating tensioner 5506, tension can be reduced.
  • implant 3800 is released from delivery device 3600 by cutting cinch line 3614 at deployment control assembly 5500 and subsequently pulling cinch line 3614 from delivery catheter 3604.
  • control assemblies provide various control elements for actuating various components of delivery device 3600.
  • control elements include those for extending and retracting sheath 3616, steering delivery catheter 3604, extending and retracting extension member 3606, expanding and collapsing control arm assembly 3608, and controlling tension on cinch line 3614.
  • FIG. 60 is a photograph illustrating a proximal portion of delivery device 3600 and, in particular, a control assembly 6000 of delivery device 3600.
  • control assembly 6000 combines various control assembly sections previously discussed in this disclosure.
  • control assembly 6000 combines (from most distal to most proximal) each of sheath control assembly 5200, steering control assembly 4600, and deployment control assembly 5500.
  • control assembly 6000 is intended only as an example control assembly for use with delivery devices according to this disclosure and that provides various functions for delivering, deploying, and implanting valve repair implants. While not specifically illustrated other implementations of control assemblies may include alternative arrangements of control assembly sections and additional structural elements (e.g., an outer housing, grips, etc.), among other things.
  • FIG. 61 is a photograph illustrating an example mounting arrangement for delivery device 3600, including control assembly 6000.
  • control assembly 6000 is received within a mount 6050 coupled to and supported by a rail 6052.
  • Rail 6052 is coupled to an articulating arm 6060, which may be fixed to a bed, table, support stand, or similar stable structure.
  • mount 6050 includes a rotating cradle 6054 that receives delivery device 3600.
  • mount 6050 is coupled to rail 6052 by a stepper-type mount such that insertion of delivery device 3600 is controllable by a knob 6056.
  • Mount 6050 may further include additional controls for locking each of rotating cradle 6054 and the position of mount 6050 on rail 6052.
  • FIG. 62 is a block diagram illustrating a method 6200 for implanting implant 3800 using delivery device 3600.
  • implant 3800 is delivered to a patient atrium, e.g., via an antegrade percutaneous route (e.g., a trans-femoral or trans-jugular route).
  • implant 3800 is coupled to a distal end of delivery device 3600 by cinch line 3614 with sheath 3616 extending over a distal end of delivery device 3600, including at least a portion of implant 3800.
  • coupling of implant 3800 to delivery device 3600 may include routing cinch line 3614 through a first set of apertures disposed around an interior circumference of implant 3800, such as a series of loops or rings distributed about the interior circumference of implant 3800.
  • Cinch line 3614 is further routed through a second set of apertures of control arm assembly 3608, thereby coupling implant 3800 to control arm assembly 3608 using cinch line 3614.
  • the apertures of control arm assembly 3608 may be rings coupled to proximal portions of the distal control arms of control arm assembly 3608.
  • FIG. 59 shows ring 3646 coupled to proximal portion 3641 of distal arm 3640.
  • navigating delivery device 3600 and implant 3800 to the implantation site may include routing delivery device 3600 along a guidewire previously inserted into the patient and extending to the atrium.
  • Step 6204 includes retracting sheath 3616 to facilitate subsequent deployment of implant 3800.
  • retracting sheath 3616 may include manipulating a control of control assembly 6000 to proximally translate sheath 3616 relative to delivery catheter 3604.
  • Step 6206 includes deploying implant 3800.
  • Deploying implant 3800 generally refers to the process of clearing implant 3800 from sheath 3616 and delivery catheter 3604 such that implant 3800 can be freely expanded, collapsed, and positioned for implantation.
  • Deploying implant 3800 may include partially expanding implant 3800, e.g., by expanding control arm assembly 3608. For example, a user may partially expand control arm assembly 3608 by rotating a corresponding handle or knob of control assembly 6000.
  • Deploying implant 3800 may also include at least partially extending implant 3800 distally relative to delivery catheter 3604. In at least some implementations, extending implant 3800 may include distally extending extension member 3606 relative to delivery catheter 3604 using a corresponding control of control assembly 6000.
  • Step 6208 includes retracting/de-extending implant 3800 relative to delivery catheter 3604 following at least partial expansion of implant 3800.
  • initial deployment of implant 3800 may require that implant 3800 extend to a first distal extent beyond delivery catheter 3604, e.g., to permit clearance of implant 3800 from sheath 3616 and delivery catheter 3604.
  • implant 3800 may be longitudinally retracted/de-extended to make the combination of the distal portion of delivery device 3600 and implant 3800 more compact.
  • the more compact configuration improves maneuverability of implant 3800 within the heart, thereby increasing the speed and accuracy with which implant 3800 can be positioned and implanted.
  • Step 6210 includes positioning implant 3800 for implantation.
  • positioning implant 3800 may include positioning implant 3800 such that an occlusive element of implant 3800 is at the level of the native leaflets or otherwise positioned to contact and interact with the native leaflets.
  • positioning implant 3800 may also include additional expanding, collapsing, and/or moving of implant 3800 to achieve proper positioning.
  • step 6210 may include one or more of expanding/collapsing control arm assembly 3608, extending/retracting extension member 3606, steering delivery catheter 3604, or any other articulation of delivery device 3600 necessary to properly position implant 3800 within the heart.
  • Step 6212 includes fully expanding implant 3800 once implant 3800 is in position for implantation.
  • Fully expanding implant 3800 may include expanding control arm assembly 3608 to or near its fullest extent. Notably, in most applications and when implant 3800 is properly positioned relative to the cardiac valve, such expansion will cause implant 3800 to interfere with and engage cardiac tissue.
  • implant 3800 may include outwardly protruding prongs shaped and positioned to engage tissue adjacent the valve.
  • Step 6214 includes releasing implant 3800 from delivery device 3600.
  • Releasing implant 3800 from delivery device 3600 includes decoupling implant 3800 from delivery device 3600 by removing cinch line 3614.
  • cinch line 3614 may be cut at control assembly 6000 and subsequently pulled from delivery device 3600. During pulling, the cut end of cinch line 3614 passes through the apertures of control arm assembly 3608 and implant 3800, resulting in implant 3800 being decoupled from control arm assembly 3608.
  • Step 6218 includes retracting delivery catheter 3604 from the patient, substantially completing the implantation process.
  • FIGS. 63A-64N illustrate an implant 6300 according to another implementation of the present disclosure.
  • FIG. 63A is a perspective proximal-side (atrial-side when implanted) view of implant 6300 while FIG. 63B and 63C are perspective and plan views of a distal side of implant 6300, respectively.
  • FIG. 63D is the same as FIG. 63C albeit with various dimensions indicated.
  • FIGS. 64A- 64P illustrate a frame 6355 of implant 6300 and various details of frame 6355.
  • FIGS. 63A-63C illustrate implant 6300 in an expanded state, such as when implant 6300 is implanted in a cardiac valve to be repaired.
  • implant 6300 generally includes a distal end 6340 and a proximal end 6345.
  • Distal end 6340 serves as the leading end of implant 6300 during implantation and is directed toward the ventricle following implantation within the valve annulus.
  • Implant 6300 further includes an occluder 6302 disposed at distal end 6340. Occluder 6302 is coupled to and supported on frame 6355 .
  • occluder 6302 is a cap-style occluder formed by laminating multiple sheets of material about a distal portion of frame 6355.
  • Implant 6300 further includes an outer sheet 6360 supported by frame 6355.
  • frame 6355 radiates laterally outward relative to a central longitudinal axis 6370 (indicated in FIGS. 63A and 63B) of implant 6300 with occluder 6302 forming a distal surface 6361 and outer sheet 6360 forming an annular surface 6364.
  • FIGS. 65A-65F for occluder 6302 and FIGS. 66A-67
  • Distal surface 6361 formed by occluder 6302 includes a proximal radially outward edge 6363 while annular surface 6364 of outer sheet 6360 forms each of a distal radially inward edge 6365 and a proximal radially outward edge 6366.
  • Proximal radially outward edge 6363 of distal surface 6361 and distal radially inward edge 6365 of annular surface 6364 define an opening 6367 between occluder 6302 and outer sheet 6360.
  • implant 6300 may be transitioned into a collapsed state for delivery to the target implantation site.
  • frame 6355, occluder 6302, and outer sheet 6360 may collapse symmetrically about central longitudinal axis 6370.
  • frame 6355 may be biased into expansion such that implant 6300 selfexpands into the expanded state, e.g., to anchor itself within the target cardiac valve annulus.
  • Each of occluder 6302 and outer sheet 6360 are supported on frame 6355.
  • occluder 6302 is coupled to and supported on frame 6355 by a bonding and lamination process. More specifically, at least one first layer of occluder 6302 is disposed on a distal surface of 6355 while at least one second layer of occluder 6302 is disposed on a proximal surface of frame 6355. Subsequent bonding of the layers (e.g., by application of an epoxy or other adhesive, heating, etc.) simultaneously forms occluder 6302 and couples occluder 6302 to frame 6355.
  • outer sheet 6360 is illustrated as being coupled to frame 6355 by sutures extending along distal radially inward edge 6365, proximal radially outward edge 6366, and frame 6355.
  • sutures extending along distal radially inward edge 6365, proximal radially outward edge 6366, and frame 6355.
  • occluder 6302 may have a diameter (D1) from and including about 16 mm to and including about 28 mm, with the maximum diameter generally corresponding to the diameter of occluder 6302 For example, occluder 6302 may a maximum diameter of about 22 mm.
  • outer sheet 6360 may have an inner diameter (D2) (e.g., the diameter of distal radially inward edge 6365) from and including about 36 mm to and including about 46 mm.
  • D2 inner diameter
  • distal radially inward edge 6365 may have a diameter of about 41 mm.
  • the sinusoidal edge of frame 6355 reduces the proximal portion of outer sheet 6360 as compared to similar configurations with the same maximum diameter but a circular proximal edge, thereby reducing the potential for interference between implant 6300 and other cardiac structures.
  • the minimum diameter of proximal radially outward edge 6363 may be from and including about 48 mm to and including about 68 mm.
  • the minimum diameter of proximal radially outward edge 6363 may be approximately 58 mm.
  • the maximum diameter of proximal radially outward edge 6363 (D4) may be from and including about 58 mm to and including about 78 mm, but at least as large as the minimum diameter of proximal radially outward edge 6363.
  • the maximum diameter of proximal radially outward edge 6363 may be about 68 mm.
  • proximal radially outward edge 6363 provides certain advantages, such a configuration is not necessary and implementations of this disclosure are not limited to configurations in which proximal radially outward edge 6363 varies. Accordingly, while not specifically illustrated in the context of implant 6300, this disclosure also contemplates that proximal radially outward edge 6363 of implant 6300 may be of constant diameter/circular.
  • the height of implant 6300 is generally defined as the distance between distal extent 6375 and the proximal extent of proximal radially outward edge 6363. Like other aspects of implant 6300, the height of implant 6300 may vary, e.g., to accommodate variations in patient anatomy. In at least certain implementations, however, the overall height of implant 6300 may be from and including about 15 mm to and including about 25 mm. For example, the overall height of implant 6300 may be approximately 20 mm.
  • FIGS. 64A-M illustrate frame 6355 in detail. More specifically, FIG. 64A is a distal isometric view of frame 6355, FIG. 64B is a distal elevation view of frame 6355, and FIG. 64C is an elevation view of frame 6355.
  • FIGS. 64D and 64E are views of frame 6355 indicating specific features and elements of interest.
  • FIGS. 64F-64K are detailed views of those features.
  • FIGS. 64L and FIG. 64M are side/elevation views of frame 6355 while FIG. 64N is a detailed view of a single spoke of frame 6355.
  • frame 6355 includes distal frame portion 6358, which supports occluder 6302 when fully assembled, and a proximal frame portion 6359, which supports outer sheet 6360.
  • each of distal frame portion 6358 and proximal frame portion 6359 include a set of circumferentially distributed petal portions configured to collapse and expand as implant 6300 is similarly collapsed and expanded during delivery and implantation.
  • distal frame portion 6358 may include radially extending and circumferentially distributed inner petal portions, such as inner petal portion 6380A and inner petal portion 6380B.
  • the inner arcuate petal portions may be ovate, diamond-shaped, or otherwise have a similar elongate shape (e.g., generally diamond shaped albeit with rounded vertices and/or curved edges).
  • Each inner petal portion may be defined by respective major and minor axes. For example, as shown in FIG.
  • inner petal portion 6380A has a major axis 6381A that extends in a radial/longitudinal direction and a minor axis 6382A that extends in a substantially circumferential direction.
  • adjacent inner petal portions may be joined at or near the vertices along the minor axis.
  • inner petal portion 6380A and inner petal portion 6380B are joined at a junction 6384 disposed distal minor axis vertices of inner petal portion 6380A and inner petal portion 6380B.
  • proximal frame portion 6359 may similarly include outer petal portions that may be ovate, diamond-shaped, or have another elongate shape. Each such outer petal portion may be defined by respective major and minor axes.
  • outer petal portion 6385A may have a major axis 6386A that extends in a substantially longitudinal direction and a minor axis 6387A that extends in a circumferential direction.
  • adjacent outer petal portions of proximal frame portion 6359 may be joined at or near the vertices along the minor axis (i.e., the co-vertices of the outer petal portions).
  • outer petal portion 6385A and outer petal portion 6385B are joined at a junction 6389 disposed at the corresponding co-vertices of outer petal portion 6385A and outer petal portion 6385B.
  • frame 6355 generally includes members, struts, spokes, or similar elongate members.
  • the spokes When frame 6355 is in a collapsed state, the spokes extend in a substantially longitudinal direction; however, as frame 6355 expands, the spokes/struts extend radially outward as well as proximally.
  • a spoke/strut extends from each of the arcuate petal portions of the distal frame portion 6358 and, more specifically, from the proximal vertex of each of arcuate petal portion.
  • FIGS. 64B and 64J illustrate each of a spoke 6395A extending from a vertex 6396A of inner petal portion 6380A and a spoke 6395B extending from vertex 6396B of inner petal portion 6380B.
  • each spoke extends from its corresponding inner petal portion of distal frame portion 6358 to a respective junction between outer arcuate petal portions of the proximal frame portion 6359.
  • FIG. 64M illustrates spoke 6395C terminating at junction 6389 between outer petal portion 6385A and outer petal portion 6385B.
  • Each spoke may further extend to form an anchor member (e.g., a spike, tine, or hook) disposed between adjacent outer petal portions.
  • an anchor member e.g., a spike, tine, or hook
  • FIGS. 64B and 64M include anchor member 6399 disposed between outer petal portion 6385A and outer petal portion 6385B and extending from junction 6389.
  • anchor members are included between each pair of adjacent outer petal portions; however, this disclosure contemplates that more or fewer anchor members may be included and the distribution of anchor members about frame 6355 may vary.
  • additional anchor members may extend from the distal vertex of one of more of the outer petal portions.
  • FIGS. 64D and 64E are views of frame 6355 indicating specific features and elements of interest, which are shown in detail in subsequent FIGS. 64F-64I. More specifically, FIG. 64D is a side elevation view of frame 6355 with frame 6355 oriented with a spoke/anchor member directed outward from the figure. In contrast, FIG. 64E is an angled side view of frame 6355 with frame 6355 oriented with an outer petal portion directed outward from the figure (i.e., at a 90-degree rotation relative to the view shown in FIG. 64D). As shown in FIG. 64D, FIG.
  • 64F is a side elevation view of a portion of frame 6355 and, in particular, a detailed view of a spoke section 6400 extending that generally extends between an inner petal portion of frame 6355 and a junction between adjacent outer petal portions.
  • spoke section 6400 may correspond to sections of spoke 6395A and spoke 6395B extending between the inner petal portions of frame 6355 and their corresponding junctions of outer petal portions.
  • the specific curvature of spoke section 6400 is discussed below in further detail in the context of FIGS. 64N-P.
  • spoke section 6400 has a generally distally convex curvature.
  • spoke section 6400 may have a thickness 6402 from and including about 0.2 mm to and including about 0.4 mm.
  • thickness 6402 may be about 0.32 mm with a tolerance of +/- 0.04 mm.
  • frame 6355 is formed by cutting frame 6355 from a tubular substrate
  • thickness 6402 may correspond to the thickness of the tubular substrate.
  • FIG. 64G is a side elevation view of an anchor member 6404 of frame 6355.
  • anchor member 6404 may correspond to anchor member 6399 of frame 6355 or any other anchor member distributed about frame 6355.
  • anchor members of implants according to this disclosure are generally configured to engage tissue surrounding the valve annulus to facilitate anchoring of the implant relative to the valve annulus during implantation.
  • the specific size, shape, angle, and similar characteristics of anchor member 6404 may vary based on the application; however, FIG. 64G illustrates one non-limiting example configuration of anchor member 6404 that has demonstrated positive results in testing.
  • anchor member 6404 extends from a junction 6406, which, as previously discussed, is generally located between adjacent outer petal portions.
  • junction 6389 of frame 6355 is shown in FIG. 64B as being located between outer petal portion 6385A and outer petal portion 6385B.
  • anchor member 6404 may be integral with junction 6406 and may be formed by distally bending or curving anchor member 6404.
  • Performance characteristics of anchor member 6404 can also be varied and controlled by modifying a thickness 6412 of anchor member 6404. While thickness 6412 may vary, in at least some implementation, thickness 6412 may be from and including about 0.2 mm to and including about 0.4 mm. For example, thickness 6412 may be about 0.32 mm with a tolerance of +/- 0.04 mm. In implementations in which frame 6355 is formed by cutting frame 6355 from a tubular substrate, thickness 6412 may correspond to the thickness of the tubular substrate.
  • the width of petal section 6420A and petal section 6420B can be varied and controlled and are not necessarily limited to any specific dimensions of the tubular substrate from which frame 6355 is cut.
  • FIG. 64H illustrates a width 6422 of each of petal section 6420A and petal section 6420B. While width 6422 may vary, in at least certain implementations, width 6422 may be from and including about 0.2 mm to and including about 0.4 mm. For example, in one specific implementation, width 6422 may be 0.32 mm with a tolerance of +/- 0/04 mm.
  • frame 6355 may be formed from a variety of superelastic and/or shape memory materials, including, for example, nickel-titanium alloys (e.g., Nitinol), which may be laser cut from a tube or in the form of drawn wire.
  • Nitinol nickel-titanium alloys
  • the features defined in the shape memory materials may be defined therein via various cutting methods known in the art, include laser, waterjet, electrical discharge machining (EDM), stamping, etching, milling, etc.
  • frame 6355 is shown with two dimensions indicated.
  • H3 the height of the anchor members of frame 6355 relative to the distal extent of frame 6355 is indicated as H3.
  • H3 may be from and including about 9 mm to and including about 15 mm and, in one specific example may be approximately 12 mm.
  • H6 may be from and including about 2 mm to and including about 4 mm and, in one specific example may be approximately 3 mm.
  • R2 may be from and including about 4 mm to and including about 10 mm and, in one specific example may be approximately 7 mm.
  • H8 corresponds to a height of distally concave section 6441.
  • Distally concave section 6441 generally extends between proximally concave section 6439 and inner petal portion 6440.
  • distally concave section 6441 is generally defined in FIG. 64N by a height H8 and a radius of curvature R3 with H8 corresponding to a distance between a proximal extent of distally concave section 6441 and the beginning of inner petal portion 6440.
  • H8 may be from and including about 2.5 mm to and including about 8.5 mm and, in one specific example may be approximately 5.5 mm.
  • R3 may be from and including about 4 mm to and including about 10 mm and, in one specific example may be approximately 7 mm.
  • dimension H9 corresponds to a height of inner petal portion 6440 and is generally defined as the distance between the end of proximally concave section 6439 and the distal extent of frame 6355.
  • H9 may be from and including about 1.5 mm to and including about 4 mm and, in one specific example may be approximately 2.5 mm.
  • R4 may be from and including about 30 mm to and including about 50 mm and, in one specific example may be approximately 40 mm.
  • occluder 6302 is generally formed directly onto distal frame portion 6358 of frame 6355. More specifically, occluder 6302 is formed onto the inner petal portions of distal frame portion 6358. While this disclosure contemplates that occluder 6302 may be formed onto distal frame portion 6358 in various ways, in at least one implementation, occluder 6302 is formed onto distal frame portion 6358 by applying a first sheet 6502 of substantially impervious material onto a distal surface 6504 (shown most clearly in FIG. 65D) of distal frame portion 6358.
  • a second sheet 6506 of porous or semi-porous material is then disposed on a proximal surface 6508 of distal frame portion 6358 such that second sheet 6506 substantially overlaps first sheet 6502 with the inner petal portions of distal frame portion 6358 disposed between first sheet 6502 and second sheet 6506.
  • An epoxy, adhesive, or similar bonding material is then applied to proximal surface 6508 of distal frame portion 6358 such that it penetrates second sheet 6506 and, once cured, bonds second sheet 6506 to first sheet 6502 and the inner petal portions of distal frame portion 6358.
  • FIG. 65D is an exploded view of occluder 6302 and frame 6355. As shown, each of first sheet 6502 and second sheet 6506 are cut and shaped to be received onto and bonded to distal frame portion 6358 of frame 6355.
  • first sheet 6502 is formed from an engineering polymer that is biocompatible and has low porosity. In certain implementations, for example, first sheet 6502 may be formed from expanded polytetrafluoroethylene (ePTFE) or a similar polymer.
  • ePTFE expanded polytetrafluoroethylene
  • Second sheet 6506 in contrast, may be formed from a substantially more porous and flexible material.
  • second sheet 6506 is formed from a porous and biocompatible fabric, such as a woven polyethylene terephthalate (PET) material.
  • PET polyethylene terephthalate
  • the material of second sheet 6506 may be the same as or similar to that used for outer sheet 6360 of implant 6300 (shown in FIG. 63A).
  • first sheet 6502 and second sheet 6506 to each other and to distal frame portion 6358
  • bonding is achieved using a combination of a siloxane segmented polyurethane and a polymer precursor, such as tetra hydrofuran (THF).
  • THF tetra hydrofuran
  • the polyurethane is solved in the THF and the resulting mixture is applied to second sheet 6506 and proximal surface 6508 of distal frame portion 6358 following layering of first sheet 6502 and second sheet 6506 onto distal frame portion 6358.
  • the relatively high viscosity of the polyurethane/THF mixture allows for relatively easy penetration of second sheet 6506, encapsulation of the fibers of second sheet 6506, and flow into the volume between first sheet 6502 and second sheet 6506 containing distal frame portion 6358.
  • the polyurethane/THF mixture provides a robust, consistent, and substantially impermeable bond between first sheet 6502 and second sheet 6506.
  • polyurethane and certain polyurethane-based compounds are capable of curing/setting without application of additional heat which may cause frame 6355 to deform or lose shape.
  • FIGS. 65E and 65F are distal and side elevation views of frame 6355 including occluder 6302 following bonding of occluder 6302 to frame 6355.
  • occluder 6302 may generally have a diameter D1. While D1 may vary in applications of the present disclosure, in certain implementations, D1 may be from and including about 16 mm to and including about 28 mm. In other implementations, D1 may be from and including about 20 mm to and including about 22 mm. In one specific implementation, D1 is about 21.4 mm with a tolerance of +/-0.5 mm.
  • occluder 6302 may also be constructed to have a defined height, as indicated by dimension H10.
  • H10 generally corresponds to the distance between a distal tip of occluder 6302 (which generally corresponds to the distal extent of implant 6300) and a proximal edge of occluder 6302 (e.g., proximal radially outward edge 6363 shown in FIGS. 63A and 64B).
  • H10 may vary; however, in certain implementations, H10 may be from and including about 3.0 mm to and including about 5 mm. For example, in one implementation H10 is approximately 4 mm with a tolerance of +/-0.5 mm.
  • FIGS. 66A and 66B illustrate an occluder 6602 that may be used for implant 6300 and other implants according to this disclosure as an alternative or variation of occluder 6302.
  • FIGS. 68A is a distal view of alternative occluder 6602 as coupled to frame 6355 of implant 6300 while FIGS. 68B is a proximal view of occluder 6602 similar assembled as implant 6300.
  • occluder 6302 has a concave proximal surface.
  • occluder 6602 is configured to have a proximal surface 6604 that is convex.
  • convex proximal surface 6604 can provide benefits to hemodynamic flow across implant 6300 by more effectively directing flow around occluder 6602.
  • occluder 6602 may have a multi-part construction including a distal section 6606 coupled to a proximal section 6608.
  • Distal section 6606 is distally concave and may be substantially similar to occluder 6302.
  • Proximal section 6608 in contrast, is distally concave and is coupled to distal section 6606 such that occluder 6602 has an overall pillow shape.
  • proximal section 6608 is coupled to distal section 6606 by suturing distal section 6606 to proximal section 6608; however, this disclosure contemplates that proximal section 6608 may be coupled to distal section 6606 using other methods, such as adhesives, epoxies, welding/bonding, and the like.
  • Sheet 6610 may similarly be formed from various materials; however, in certain implementations, sheet 6610 may be formed from a porous material, such as the woven PET used for second sheet 6506 of occluder 6302 and outer sheet 6360 of implant 6300. Among other things, using a porous material allows an internal volume 6616 of occluder 6602 to be flushed of air in preparation for delivery and implantation.
  • a porous material such as the woven PET used for second sheet 6506 of occluder 6302 and outer sheet 6360 of implant 6300.
  • internal volume 6616 may be filled with an epoxy, solidifying gel, solid insert, or similar material or object that substantially fills internal volume 6616 prior to delivery and implantation.
  • internal volume 6616 may contain a hydromorphic polymer, hydrogel, or similar substance that expands when exposed to a fluid, e.g., blood, such that the material expands to fill internal volume 6616 following implantation.
  • occluder 6602 may have a substantially solid construction.
  • occluder 6602 may be in the form of a substantially solid biocompatible body having an overall shape similar to that of occluder 6602 shown in FIGS. 66A and 66B and that can be readily coupled to distal frame portion 6358 to form occluder 6602.
  • implant 6300 includes outer sheet 6360, which extends circumferentially about a proximal portion of frame 6355.
  • Outer sheet 6360 provides various functions including, but not limited to, protecting tissue around the valve annulus from frame 6355, facilitating alignment of implant 6300 within the valve annulus, and anchoring implant 6300 at its implantation location (e.g., through tissue ingrowth into outer sheet 6360). Further details regarding construction and assembly of outer sheet 6360 are now provided with reference to FIGS. 67A-67D.
  • FIG. 67A is a side view of the distal face of implant 6300.
  • implant 6300 includes occluder 6302 at distal end 6340 and coupled to frame 6355.
  • Implant 6300 further includes outer sheet 6360, which extends circumferentially about a proximal portion of frame 6355 and is also coupled to and supported by frame 6355.
  • outer sheet 6360 may vary, in the implementation shown in FIG. 67A, distal radially inward edge 6365 of outer sheet 6360 is circular and while proximal radially outward edge 6366 has a sinusoidal/repeating shape.
  • FIG. 67B is a proximal side view of a section of frame 6355 and outer sheet 6360 of implant 6300 and further illustrates assembly of outer sheet 6360 to frame 6355.
  • the specific view shown in FIG. 67B illustrates coupling of outer sheet 6360 to each of a first outer petal portion 6702A and a second outer petal portion 6702B of frame 6355.
  • first outer petal portion 6702A includes a frame section 6704A and a frame section 6704B, with frame section 6704B extending between a distal vertex 6706 of first outer petal portion 6702A and a junction 6708 formed between first outer petal portion 6702A and second outer petal portion 6702B.
  • first outer petal portion 6702A includes a frame section 6704A and a frame section 6704B, with frame section 6704B extending between a distal vertex 6706 of first outer petal portion 6702A and a junction 6708 formed between first outer petal portion 6702A and second outer petal portion 6702B.
  • three suture loops 6709A-6709C are placed to couple outer sheet 6360 to frame 6355. Additional sutures loops are distributed about junction 6708 to further reinforce the coupling of junction 6708 to frame 6355.
  • An additional suture 6709D is positioned proximal junction 6708 for
  • Outer sheet 6360 is also coupled to frame 6355 by hems extending along each of the proximal and distal edges of frame 6355.
  • a first hem 6710 extends along radially inward edge 6365, enveloping the distal vertices of the outer petal portions (e.g., distal vertex 6706 of first outer petal portion 6702A).
  • a second hem 6712 extends along proximal radially outward edge 6366, conforming to the variable shape of proximal radially outward edge 6366.
  • Second hem 6712 is shown as being discontinuous between petal portions, e.g., atjunction 6708. Despite this continuity, the suture used to form the discrete sections of second hem 6712 may be continuous and may be routed across the junctions between petal portions. For example, FIG. 67B shows a suture segment 6722 that crosses junction 6708 and is continuous between first hem segment 6718A and second hem segment 6718B.
  • FIGS. 67C and 67D illustrate proximal vertex 6716 and distal vertex 6706, respectively, in further detail.
  • a suture wrap may be formed at one or both of proximal vertex 6716 and distal vertex 6706.
  • a proximal suture wrap 6724 is shown in FIG. 67C extending around proximal vertex 6716 while a distal suture wrap 6726 is shown in each of FIGS. 67C and 67D extending around distal vertex 6706.
  • Including suture wraps as shown provides several notable advantages. As a first example, each of the suture wraps provides robust and reinforced coupling of outer sheet 6360 to frame 6355.
  • the suture wraps also provide additional padding around the vertices of the outer petal portions of frame 6355.
  • the suture wraps may fill gaps between hem segments.
  • proximal suture wrap 6724 is disposed between first hem segment 6718A and second hem segment 6718B and may fill/cover any gap that may be present between the two segments despite the folding of first hem segment 6718A over second hem segment 6718B.
  • outer sheet 6360 is wrapped around frame 6355 as shown in the preceding figures and sutured/stitched onto frame 6355.
  • Such suturing/stitching generally includes forming each of first hem 6710 and second hem 6712 and forming any additional suture loops (e.g., suture loops 6709A-6709).
  • outer sheet 6360 includes an open side 6732 that is closed as outer sheet 6360 is wrapped about frame 6355.
  • outer sheet 6360 may include an additional tab, such as tab 6734, to keep outer sheet 6360 in a closed configuration while being coupled to frame 6355.
  • tab 6734 may be folded inward (e.g., along fold line 6736) and held in place by a suture/stitch. Doing so maintains an approximate shape of outer sheet 6360 and facilitates folding and forming of the various hems and suture loops necessary to securely couple outer sheet 6360 to frame 6355.
  • outer sheet 6360 includes cutting outer sheet 6360 from a sheet of suitable material (e.g., woven PET) and attaching outer sheet 6360 to frame 6355 using a combination of hems and suture loops.
  • a sheet of suitable material e.g., woven PET
  • coupling of outer sheet 6360 to frame 6355 may be achieved using a monofilament suture, a multifilament suture, or a combination of mono- and multifilament sutures.
  • this disclosure contemplates that outer sheet 6360 may be coupled to frame 6355 using sutures, adhesives, welding, or any combination thereof.
  • one of heat welding or ultrasonic welding may be used to close the various hems illustrated in the preceding figures.
  • polyurethane, silicone, or a similarly suitable and biocompatible adhesive, epoxy, bonding agent, etc. may be employed.
  • This disclosure also contemplates that multiple fixation techniques may be used to couple outer sheet 6360 to frame 6355.
  • adhesive may be initially used to perform an initial or partial coupling of outer sheet 6360 to outer sheet 6360 but may be supplemented or reinforced by suturing, welding, etc.
  • Implant delivery systems of the present disclosure generally rely on two mechanisms for controlling expansion and collapse of implants during delivery.
  • implants according to this disclosure may be disposed on a control arm assembly of the delivery tool.
  • the control arm assembly includes control arms configured to radially expand and contract in response to manipulation of a corresponding control of a handle assembly of the delivery tool.
  • the control arm are coupled to the frame of the implant such that as a clinician expands the control arms radially outward, the implant expands. Similarly, as the clinician retracts the control arms radially inward, the implant is pulled inward and collapsed.
  • delivery systems according to the present disclosure may include one or more cinch lines.
  • each cinch line may be similarly routed through delivery catheter assembly, but only partially about the circumference of the implant.
  • each cinch line may extend about approximately half of the circumference of the implant and meet at a retention location.
  • Each cinch line may terminate in a loop or similar feature through which a retention pin or cable may be passed to retain the cinch lines during delivery and implantation.
  • the one or more cinch lines provide various functions and benefits.
  • the one or more cinch lines retain the implant on the control arms; however, by maintaining tension of the one or more cinch lines during expansion and collapse of the implant, the uniformity of expansion and collapse can be substantially improved due to the cinch lines distributing expansion/collapse forces evenly about the implant.
  • maintain tension on the one or more cinch lines also provides improve responsiveness of the implant expansion and collapse controls by reducing or eliminating slack that may need to be overcome before manipulation of a control by the clinician results in corresponding movement of the implant.
  • the cinch lines must be decoupled from the implant to permit release of the implant and subsequent removal of the delivery system.
  • the cinch line may be cut at a proximal location and subsequently pulled through the catheter assembly.
  • the retention cable may be retracted to release the cinch lines, which may then be retracted through the delivery catheter. This process and an example handle assembly for sequencing of retention cable and cinch line retraction is described below in further detail in the context of FIGS. 83A-86D.
  • implementations of this disclosure include various features for more reliable and consistent routing of cinch lines and, in particular, consistent retraction of cinch lines during release of the implant from the delivery system.
  • routing rings e.g., ring 3646
  • cinch line 3614 is routed through each of the routing rings and corresponding rings (e.g., ring 3804) coupled to the frame of implant 3800.
  • improved cinch line routing is provided by a series of eyelets coupled to the implant frame. More specifically, specially designed eyelets are coupled to the frame of the implant such that the eyelets are distributed circumferentially about the radially inward surface of the implant.
  • the junctions between adjacent outer petal portions of the implant frame include a slot through which the separately manufactured eyelets are inserted.
  • the eyelets are rigidly retained using one or more coupling techniques and form a consistent and reliable path for the one or more cinch lines about the circumference of the implant.
  • Additional features such as a smooth, radius inner bore, reduce the likelihood of cinch lines binding or snagging as they are retracted through the eyelets, thereby improving the overall reliability and consistency with which the cinch lines can be retracted during release of the implant from the delivery device.
  • FIGS. 69A and 69B are a partial proximal view and a detailed proximal view, respectively, of implant 6300.
  • Implant 6300 is discussed in detail in previous sections; however, implant 6300 generally includes frame 6355, which includes a series of circumferentially distributed spokes that extend from a distal frame portion 6358 to a proximal frame portion 6359.
  • Proximal frame portion 6359 includes a series of circumferentially distributed outer petal portions, such as outer petal portion 6385A and outer petal portion 6385B. Each pair of outer petal portions meet at a junction, such as junction 6384. Each junction further connects with one of the spokes extending from distal frame portion 6358.
  • junction 6384 connects outer petal portion 6385A, outer petal portion 6385B, and spoke 6395A.
  • an anchor member such as anchor member 6399 may also extend from junction 6384.
  • each junction of frame 6355 may further include an eyelet for use in routing one or more cinch line about the inner surface of implant 6300.
  • FIG. 69B illustrates an eyelet 6802 located at and coupled to junction 6384. Additional eyelets are also shown coupled to adjacent junctions.
  • each junction of frame 6355 may include a respective eyelet such that the eyelets extend about the full circumference of implant 6300 and enable corresponding and complete routing of one or more cinch lines about implant 6300.
  • FIG. 70 is an isometric view of eyelet 6802
  • FIGS. 71 A-C are plan, bottom, and cross- sectional views of eyelet 6802, respectively.
  • eyelet 6802 generally includes a shank 6804 extending in a first direction and a body 6808 extending perpendicularly from shank 6804.
  • shank 6804 defines a retention hole 6806 that may be used to couple eyelet 6802 to frame 6355 using a suture loop or similar coupling element.
  • Body 6808 similarly defines a cinch line hole 6810 that extends through body 6808 and that is generally sized and shaped to permit threading of the cinch line through cinch line hole 6810.
  • an undercut may be made on either side of body 6808 where body 6808 meets shank 6804.
  • FIG. 70 indicates undercut 6812A on a first side of body 6808 and undercut 6812B on an opposite side of body 6808.
  • undercut 6812A and undercut 6812B facilitate flush contact between shank 6804 and the proximal side of junction 6384 when eyelet 6802 is assembled with frame 6355.
  • FIGS. 71A-71C illustrate additional views of eyelet 6802 including various dimensions.
  • the specific dimensions of eyelet 6802 may vary and any ranges or dimensions specifically mentioned in this disclosure in this and other sections are intended merely as examples that reflect certain positive outcomes during development and testing.
  • dimension W1 corresponds to a width of body 6808
  • dimension D5 corresponds to a diameter of the through hole of cinch line hole 6810
  • H11 corresponds to an offset between the top extent of shank 6804 and the beginning of the radius of cinch line hole 6810
  • D6 corresponds to a diameter of retention hole 6806.
  • W1 may be from and including about 0.9 mm to and including about 1.0 mm and, in one specific example is approximately 0.927 mm with a tolerance of +/-.02 mm.
  • D5 may be from and including about 0.55 mm to and including about 0.6 mm and, in one specific example is approximately 0.527 mm with a tolerance.
  • H11 may be from and including about 0.55 mm to and including about 0.65 mm and, in one specific example is approximately 0.596 mm with a tolerance of +/-.02 mm.
  • D6 may be from and including about 0.35 mm to and including about 0.4 mm and, in one specific example is approximately 0.38 mm.
  • FIG. 71 B is a bottom view of eyelet 6802 and includes dimensions W2, which corresponds to the width of shank 6804, and T1 , which corresponds to the thickness of eyelet 6802.
  • W2 may be from and including about 1.8 mm to and including about 2.0 mm and, in one specific example is approximately 1.875 mm with a tolerance of +/-.02 mm.
  • T1 may be from and including about 0.3 mm to and including about 0.4 mm and, in one specific example is approximately 0.36 mm with a tolerance of +/-.02 mm.
  • FIG. 71 C is a cross-sectional view of body 6808 across cinch line hole 6810 as indicated in FIG. 71 A.
  • cinch line hole 6810 may have radiused or otherwise machined sides to eliminate any sharp edges that may catch or otherwise impede cinch line retraction.
  • the radius of cinch line hole 6810 is indicated as R5 in FIG. 71C.
  • R5 may be from and including about 0.15 mm to and including about 0.20 mm and, in one specific example is approximately 0.18 mm.
  • FIG. 72 is a detailed view of junction 6384 with eyelet 6802 removed. More specifically, FIG. 72 is a detailed view from a perspective orthogonal to a slot 7202 on a distal side of frame 6355. As previously discussed, junction 6384 provides a connection location between spoke 6395A, outer petal portion 6385A, and outer petal portion 6385B, and anchor member 6399 may extend outward from junction 6384.
  • Slot 7202 is defined by and extends through junction 6384 and is shaped to receive eyelet 6802.
  • slot 7202 may be laser cut or otherwise formed in the same process as the rest of frame 6355 (e.g., a process by which frame 6355 is laser cut from a tubular substrate, such as a nitinol tube).
  • Slot 7202 may vary in size and shape depending on the scale of frame 6355 and, more specifically, the size and shape of eyelet 6802. Nevertheless, in certain implementations, slot 7202 may generally have a width W2 and a length L1 , with W2 corresponding to a dimension extending perpendicular to spoke 6395A and L extending parallel to spoke 6395A.
  • W may be from and including about 0.3 mm to and including about 0.5 mm.
  • W2 may be approximately 0.405 mm with a tolerance of +/- 0.03 mm.
  • L1 may vary in different implementations of this disclosure; however, in certain implementations, L1 may be from and including about 0.75 mm to and including about 1.5 mm. In one specific example, L1 is approximately 1.075 mm with a tolerance of +/- 0.03 mm.
  • FIG. 73A is a cross-sectional view of junction 6384 with eyelet 6802 installed.
  • eyelet 6802 is inserted through slot 7202 such that shank 6804 of eyelet 6802 abuts a distal surface 7302 of junction 6384 and cinch line hole 6810 extends to a proximal side 7304 of junction 6384, with the contact between shank 6804 and distal surface 7302 precluding further proximal movement by eyelet 6802.
  • Eyelet 6802 is shown as being coupled to junction 6384 by a suture loop 7306 that extends about junction 6384 and is threaded through retention hole 6806 of eyelet 6802.
  • eyelet 6802 may be retained within slot 7202 using alternative or additional means.
  • eyelet 6802 may be bonded to junction 6384 using an adhesive or by a welding process.
  • slot 7202 and body 6808 of eyelet 6802 may be sized such that an interference fit is formed between slot 7202 and body 6808 that positively retains eyelet 6802 within slot 7202.
  • outer sheet 6360 is generally disposed distal shank 6804 when implant 6300 is fully assembled. Accordingly, outer sheet 6360 may also be fitted to abut and apply proximal force to shank 6804 to facilitate retention of eyelet 6802 within slot 7202.
  • such stiffness reduction features may be configured to reduce stiffness of the tube to bending along a specific plane or in a specific direction, e.g., along a plane corresponding to a steering plane of the delivery catheter, while maintaining rigidity with respect to bending in other directions.
  • FIG. 74 illustrates an example delivery system 7400 for an implant 7402.
  • Delivery system 7400 generally corresponds to delivery device 3600, discussed above.
  • delivery system 7400 includes a steerable catheter 7404 including multiple steerable sections. While other configurations and steering arrangements of steerable catheter 7404 are contemplated by and within the scope of this disclosure, steerable catheter 7404 generally includes a distal steerable section 7406 steerable along a first plane (e.g., plane 4506, shown in FIG. 45A with bending along plane 4506 further illustrated in FIGS. 45B and 45C) and a proximal steerable section 7408 steerable along two planes (e.g., plane 4508 and plane 4510 shown in FIG.
  • a first plane e.g., plane 4506, shown in FIG. 45A with bending along plane 4506 further illustrated in FIGS. 45B and 45C
  • a proximal steerable section 7408 steerable along two planes (e.g., plane 4508 and plane 4510 shown in FIG.
  • distal tube section 7412 may correspond to distal steerable section 7406
  • first medial section 7414 may correspond to proximal steerable section 7408
  • second medial tube section 7416 may correspond to a distal segment of non-steerable catheter section 7409
  • proximal tube section 7418 may correspond to a proximal segment of non-steerable catheter section 7409.
  • internal tube 7410 is formed as a unitary tubular structure. Material of internal tube 7410 may similarly vary; however, in one specific implementation, internal tube 7410 is formed from stainless steel or a similar biocompatible material. In at least one implementation, internal tube 7410 is formed from a tube having an outer diameter from and including about 2.5 mm to and including about 3.5 mm with a wall thickness from and including about 0.1 mm to and including about 0.5 mm. For example, in one specific implementation, internal tube 7410 has an outer diameter of approximately 3 mm and a wall thickness of 0.25 mm.
  • FIGS. 76A-76D illustrate each section of internal tube 7410 in further detail.
  • FIG. 76A is a side view of distal tube section 7412 of internal tube 7410. When assembled with steerable catheter 7404, distal tube section 7412 generally corresponds to distal steerable section 7406.
  • stiffness of distal tube section 7412 is modified by a series of cuts distributed longitudinally along distal tube section 7412. More specifically, distal tube section 7412 includes first cuts 7420A extending along a first side of distal tube section 7412 and second cuts 7420B extending along a second side of distal tube section 7412. First cuts 7420A and second cuts 7420B reduce the stiffness of distal tube section 7412 relative to bending in the directions of the sides along which the cuts extend. In contrast, relatively higher stiffness is maintained for bending in directions orthogonal to the cut sides due to “spines” (e.g., spine 7421) that extend along distal tube section 7412 between the sets of cuts.
  • spikenes e.g., spine 7421
  • each of first cuts 7420A and second cuts 7420B terminate in a bulbous cutout, resulting in an overall dog-bone shape to each of the cuts.
  • the dog-bone shape generally reduces interference of the internal cut surfaces during bending. Among other things, doing so promotes more uniform bending of distal tube section 7412 and avoids binding of distal tube section 7412 during bending.
  • FIG. 76C is a side view of second medial tube section 7416 of internal tube 7410.
  • second medial tube section 7416 may correspond to a distal segment of non-steerable catheter section 7409 of steerable catheter 7404.
  • stiffness of second medial tube section 7416 is modified by one or more helical cuts, such as helical cut 7426, extending along the length of second medial tube section 7416. Given that helical cut 7426 extends around the entirety of second medial tube section 7416, it reduces stiffness of second medial tube section 7416 omnidirectionally.
  • FIG. 45 illustrates one example implementation in which a distal portion of the catheter assembly is separated into a proximal steering section and a distal steering section, each of which is independently articulable.
  • FIG. 61 illustrates an example delivery device mount that includes a rail and cradle supporting the delivery device.
  • the cradle is movable/translatable along the rail (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 may be rotated within the cradle while maintaining longitudinal alignment.
  • implant 7950 is maintained in a retracted and sheathed configuration during delivery of distal end 7906 of delivery device 7900 into the right atrium and with implant 7950 coupled to distal end 7906.
  • the clinician unsheathes and expands implant 7950 and aligns implant 7950 to be normal to the tricuspid valve annulus, e.g., by steering catheter assembly 7904.
  • extension tube 7910 is extended to translate implant 7950 into the valve annulus for subsequent release.
  • extension shuttle 7924 translates within aperture 7918, moving the location of shuttle indicator 7922 and communicating translation of extension tube 7910.
  • a scale 7926 is coupled to housing 7916 adjacent shuttle indicator 7922 and includes markers corresponding to various degrees of extension and retraction of extension tube 7910 to communicate the current extension/retraction state to the clinician.
  • FIGS. 80A and 80B illustrate delivery device handle assembly 7902 with housing 7916 removed and are intended to explain operation of handle assembly 7902 to extend and retract extension tube 7910. More specifically, FIG. 80A illustrates handle assembly 7902 in a first state corresponding to extension tube 7910 being in a fully extended configuration (e.g., similar to that illustrated in FIGS. 79A and 79B) while FIG. 80B illustrates handle assembly 7902 in a second state corresponding to extension tube 7910 being in a fully retracted configuration (e.g., similar to that illustrated in FIGS. 79C and 79D).
  • Shuttle indicator 7922 is also included in FIGS. 80A and 80B in position but decoupled from housing 7916 for purposes of more clearly illustrating shuttle indicator 7922 and its relationship with extension shuttle 7924.
  • Extension knob 7914 is coupled to an extension shaft 7928 that extends distally from extension knob 7914 into housing 7916 and is coupled to a distal member 7930 of housing 7916, thereby longitudinally fixing extension shaft 7928.
  • Extension shaft 7928 is at least partially threaded and extends through a threaded hole 7932 of extension shuttle 7924.
  • extension shuttle 7924 further may include one or more guide bores (e.g., guide bore 7925) through which corresponding guide members (e.g., guide member 7927) extend to maintain alignment of and to support extension shuttle 7924 and along which extension shuttle 7924 translates.
  • guide bores e.g., guide bore 7925
  • guide members e.g., guide member 7927
  • extension shaft 7928 longitudinally drives extension shuttle 7924 along the guide members and, as a result, extends or retracts extension tube 7910 based on the direction of rotation of extension knob 7914.
  • delivery device 3600 includes circumferentially distributed control arms (such as the control arms of control arm assembly 3608 shown in FIGS. 42 and 43) that can be made to extend radially and apply radially outward force by longitudinal translation of control arm shaft 3642.
  • circumferentially distributed control arms such as the control arms of control arm assembly 3608 shown in FIGS. 42 and 43
  • FIGS. 82A-82C An example mechanism for achieving synchronized control arm shaft and cinch line manipulation is illustrated in FIGS. 82A-82C, which illustrate handle assembly 7902 with housing 7916 removed. More specifically, FIG. 82A illustrates handle assembly 7902 in a state corresponding to full collapse of the implant 7950 (e.g., as shown in FIGS. 81A and 81 B), FIG. 82B shows a partially transparent detailed view of extension shuttle 7924, and FIG. 82C illustrates handle assembly 7902 in a state corresponding to full expansion of implant 7950 (e.g., as shown in FIGS. 81C and 81 D).
  • FIGS. 82A-82C illustrate handle assembly 7902 with housing 7916 removed. More specifically, FIG. 82A illustrates handle assembly 7902 in a state corresponding to full collapse of the implant 7950 (e.g., as shown in FIGS. 81A and 81 B), FIG. 82B shows a partially transparent detailed view of
  • expansion shaft 7938 is coupled to and directly drives expansion shuttle 7940 and that spool 7944 drives retraction and payout of the one or more cinch lines
  • gear ratio between worm gear 7958 and gear 7956 also dictates the relationship between translation of control arm shaft 7942 and payout/retraction of the one or more cinch lines.
  • Synchronizing the one or more cinch lines with translation of the control arms involves modifying the circumference formed by the one or more cinch lines about the implant with changes in the radius of the implant resulting from extension and retraction of the control arms.
  • one unit of radial change in the implant results in approximately 2TT units of circumferential change.
  • worm gear 7958, gear 7956, and spool 7944 are sized and configured such that rotation of expansion shaft 7938 resulting in one unit of radial expansion (or contraction) by the control arms results in approximately 2TT units of total cinch line payout (or retraction).
  • the 2TT units of total cinch line payout or retraction may be distributed among multiple cinch lines.
  • the worm gear 7958, gear 7956, and spool 7944 would be configured to impart approximately TT units of payout/retraction of each cinch line for each unit of radial expansion/contraction of the control arms.
  • FIG. 83A is a photograph of implant 7950 coupled to catheter assembly 7904 and FIG. 83B is a proximal schematic view of implant 7950 at an initial stage of releasing implant 7950 from catheter assembly 7904.
  • implant 7950 is supported on control arms (e.g., control arm 7966) of delivery device 7900 and maintained on the control arms by first cinch line 7962 and second cinch line 7964. Friction and/or interference between mating portions of the control arms and the frame of the implant may further facilitate retention of implant 7950 on the control arms.
  • first cinch line 7962 and second cinch line 7964 meet at retention location 7970 and are held in place by a controllable retention element.
  • the controllable retention element is a retention cable 7974 extending from catheter assembly 7904 to retention location 7970.
  • retention cable 7974 is threaded through loops or similar features at the terminal ends of first cinch line 7962 and second cinch line 7964 to retain first cinch line 7962 and second cinch line 7964.
  • pairs of cinch line tubes may be disposed on opposite sides of implant 7950 with cinch lines extending from each tube about a quarter of implant 7950. So, for example, distal outlets of two cinch line tubes may be located at a 12 o’clock position of implant 7950 with a first cinch line routed clockwise from a first tube to a 3 o’clock position and a second cinch line routed from the 12 o’clock position to a 9 o’clock position.
  • retraction of retention cable 7974, first cinch line 7962, and second cinch line 7964 is coordinated such that first cinch line 7962 and second cinch line 7964 begin retraction prior to full retraction of retention cable 7974.
  • retraction of first cinch line 7962 and second cinch line 7964 may be delayed until full retraction of retention cable 7974 into catheter assembly 7904 or, more generally, any time subsequent to initial retraction of retention cable 7974 and release of the cinch lines from retention location 7970.
  • the corresponding fit between 7900 and elements of delivery device 7900 should be designed such that decoupling force is substantially less than forces that would result in dislodging of implant 7950 from the valve annulus.
  • Retention tether 7984 is coupled to a proximal end of retention cable 7974 (shown, e.g. in FIGS. 83B and 83D) such that proximally pulling retention tether 7984 results in retraction of retention cable 7974.
  • retention cable 7974 generally retains first cinch line 7962 and second cinch line 7964 during implant delivery and deployment and retraction of retention cable 7974 releases first cinch line 7962 and second cinch line 7964 for subsequent detachment of implant 7950 from delivery device 7900.
  • Cinch line tether 7986 forms a loop about each of first cinch line 7962 and second cinch line 7964 such that proximal pulling of cinch line tether 7986 results in retraction of each of first cinch line 7962 and second cinch line 7964.
  • FIG. 85B is a detailed view of handle assembly 7902 in the area of extension shuttle 7924. As shown, tether 7986 loops about and is used to pull/retract each of first cinch line 7962 and second cinch line 7964 simultaneously. However, in other implementations, separate tethers may be included for each of first cinch line 7962 and second cinch line 7964.
  • implementations of this disclosure may include more than two cinch lines and/or more than a single retention element.
  • cinch line tether 7986 may be looped around or otherwise coupled to each of the cinch lines to perform simultaneously retraction of the cinch lines.
  • the handle assembly may include multiple cinch line tethers coupled to approximately the same location on control ring 7976 such that each of the cinch line tethers is pulled simultaneously.
  • retraction of one or more cinch lines may be staggered by coupling the cinch lines or corresponding cinch line tethers for each group to different locations about control ring 7976.
  • each retention element may be coupled to a common retention element tether that, in turn, is coupled to and pullable by control ring 7976.
  • each of the retention elements may be simultaneously pulled by rotating control ring 7976.
  • the retention elements or tethers coupled to subgroups of the retention elements may be coupled to locations around control ring 7976 such that rotation of control ring 7976 results in sequenced pulling of the retention elements.
  • the retention elements are sequenced to be retracted prior to pulling of the cinch lines such that the cinch lines are released by the retention elements and able to be retracted.
  • FIGS. 86A-86D are schematic illustrations of the view shown in FIG. 85C illustrating an example release sequence of implant 7950 from delivery device 7900 from the perspective of the release control.
  • FIG. 86A illustrates essentially the same configuration as FIG. 85C and corresponds to a state prior to beginning a release process.
  • retention tether 7984 and cinch line tether 7986 extend through aperture of proximal member 7980 and couple to control ring 7976 at first attachment location 7988 and second attachment location 7990, respectively.
  • Protrusion 7992 is positioned between aperture 7982 and control ring 7976 and along the rotational path of the tethers.
  • FIG. 86B illustrates handle assembly 7902 following a first counterclockwise rotation of control ring 7976.
  • the state shown in FIG. 86B corresponds to a stage in the implant release process following initial retraction of retention cable 7974 and which generally corresponds to a state immediately after that shown in FIG. 83B. More specifically, the state shown in FIG. 86B occurs after initial retraction of retention cable 7974 but prior to retraction of first cinch line 7962 and second cinch line 7964.
  • Rotation of control ring 7976 similarly results in a corresponding rotation of second attachment location 7990 for cinch line tether 7986 about aperture 7982.
  • cinch line tether 7986 is not made to contact protrusion 7992 and the length of cinch line tether 7986 extending between aperture 7982 and second attachment location 7990 remains constant. So, rotation of control ring 7976 as shown in the transition between FIGS. 86A and 86B does not result in pulling of cinch line tether 7986 and first cinch line 7962 and second cinch line 7964 remain unretracted.
  • FIG. 86C illustrates handle assembly 7902 following further rotation of control ring 7976.
  • cinch line tether 7986 is about to but has not yet contacted protrusion 7992.
  • the length of cinch line tether 7986 extending from aperture 7982 to second attachment location 7990 is the same as in FIGS. 86A and 86B and pulling/retraction of the cinch lines has not yet started.
  • the additional rotation of control ring 7976 has resulted in further pulling of retention tether 7984 to accommodate the increased distance between aperture 7982 and first attachment location 7988.
  • the transition from the state shown in FIG. 86B to that shown in FIG. 86C results in further pulling of retention tether 7984 and further retraction of retention cable 7974.
  • the rate at which the tethers are pulled per unit of rotation of control ring 7976 is generally a function of the size of protrusion 7992.
  • increasing or decreasing the circumference/perimeter of protrusion 7992 can be used to increase or decrease the rate at which the tethers are pulled (all other things being equal).
  • FIGS. 77A-78C illustrate implant delivery system 7700, which includes delivery device 7702 and mounting assembly 7704.
  • mounting assembly 7704 is generally configured to support delivery device 7702 and may include various features for controlled operation of delivery device 7702.
  • FIGS. 77A and 77B illustrate longitudinal translation of delivery device 7702 relative to mounting assembly 7704 by rotation of knob 7712 to perform insertion/retraction of delivery device 7702.
  • FIGS. 78A-78C similarly illustrate manual rotation of delivery device 7702 within mounting assembly 7704. Additional details regarding mounting assemblies are provided below with specific reference to FIGS. 87A-87L, which illustrate mounting assembly 8700 and various components of mounting assembly 8700.
  • Mounting assembly 8700 is substantially like mounting assembly 7704 of FIGS. 78A-78C, so unless otherwise stated, the description of mounting assembly 7704 provided earlier in this disclosure is generally applicable to mounting assembly 8700.
  • FIG. 87A is an isometric view of a mounting assembly 8700 according to the present disclosure.
  • Mounting assembly 8700 includes a structural coupling 8702, an arm assembly 8710, and a handle mount assembly 8730.
  • FIG. 87A further includes a handle assembly element 8701 and a structural element 8703.
  • mounting assembly 8700 is coupled to and supported by structural element 8703. More specifically, structural coupling 8702 couples to structural element 8703 with arm assembly 8710 coupled to and extending from structural coupling 8702.
  • Arm assembly 8710 may be any suitable structure for supporting and adjusting the position and orientation of handle mount assembly 8730. As shown, arm assembly 8710 is a universal articulating arm structure including multiple manipulable and lockable joints. This disclosure contemplates that other support structures may be used to support and maintain position of handle mount assembly 8730 during use, arm assembly 8710 is included as a specific example that includes degrees of freedom and flexibility that are conducive to use with delivery devices of this disclosure.
  • Structural element 8703 is intended to reflect an environmental structure, such as a bed rail, to which mounting assembly 8700 may be coupled and that supports mounting assembly 8700.
  • structural element 8703 is provided as a non-limiting example of a structure to which mounting assembly 8700 may be coupled. Accordingly, any specific aspects of structural element 8703 shown in the figures should be considered non-limiting. For example, this disclosure contemplates that structural element 8703 may vary in size and shape from that shown in the figures or that mounting assembly 8700 may be coupled to structures other than bed rails, including standalone mounting systems that do not rely on other capital equipment within the operating theater.
  • FIG. 87B is an isometric view of handle mount assembly 8730 and a terminal portion of arm assembly 8710 including an interface block 8774.
  • Handle mount assembly 8730 includes a carriage assembly 8732 coupled to and movable along a rail assembly 8750.
  • Rail assembly 8750 includes a rail 8752 and a frame 8754. Carriage assembly 8732 and rail assembly 8750 are selectively coupled to arm assembly 8710 by an interface 8770.
  • Interface 8770 includes a rail-side interface element in the form of a plate 8772 that is receivable by interface block 8774.
  • interface block 8774 further includes a locking control 8776 in the form of a lever that can be selectively engaged and disengaged to fix and release plate 8772 from interface block 8774, thereby permitting selective attachment and removal of handle mount assembly 8730 from arm assembly 8710.
  • FIG. 87B further includes an extension member 8778 coupled to and extending from interface block 8774 and that couples interface block 8774 to the remainder of arm assembly 8710.
  • extension member 8778 is configured to mate with and to be coupled with a terminal end of arm assembly 8710.
  • carriage assembly 8732 includes a manually driven steppertype drive system. More specifically, carriage assembly 8732 is retained on rail assembly 8750 by a dove-tail type mating arrangement.
  • Carriage assembly 8732 includes knobs (such as knob 8740) that are rotatable to provide controlled translation of carriage assembly 8732 along rail assembly 8750.
  • knob 8740 may be coupled to an internal gear or cog of carriage assembly 8732 that mates with rail 8752 of rail assembly 8750 such that rotation of knob 8740 rotates the internal gear or cog and drives carriage assembly 8732 along rail 8752.
  • FIG. 87C is a detailed isometric view of rail assembly 8750. More specifically, FIG. 87C illustrates a distal portion of rail 8752 and frame 8754. As shown, rail assembly 8750 may have an open end 8751 to facilitate attachment and removal of carriage assembly 8732 from rail assembly 8750. In certain implementations, rail assembly 8750 may include a retention feature, such as stop 8753 that generally retains carriage assembly 8732 on rail 8752, but that can be selectively disengaged to permit sliding of carriage assembly 8732 off rail 8752 at open end 8751. For example, stop 8753 is generally biased into the configuration shown in FIG.
  • frame 8754 is shown as further including an optional stop 8756 protruding from a proximal portion of frame 8754 and that limits proximal travel of carriage assembly 8732 along rail 8752.
  • FIGS. 87G and 87H illustrate interface block 8774 in an open/unlocked state and a closed/locked state, respectively.
  • interface block 8774 transitions between the open/unlocked state of FIG. 87G to the closed/locked state of FIG 87H in response to actuation of locking control 8776.
  • locking control 8776 is in the form of a cam-style lever that drives locking pillar 8775 between a raised position (shown in FIG. 87G) and a retracted position (shown in FIG. 87H).
  • plate 8772 is slid onto interface block 8774 while locking pillar 8775 is in the open configuration shown in FIG. 87G.
  • plate 8772 is slid onto interface block 8774 such that a lip 8771 of locking pillar 8775 is received within internal channel 8777 of retention structure 8773.
  • Locking control 8776 is then actuated to retract locking pillar 8775 into interface block 8774, thereby locking interface block 8774 to plate 8772.
  • FIGS. 87J and 87K are isometric views of carriage assembly 8732. More specifically, FIG. 87J illustrates carriage assembly 8732 including a yoke 8712 and retaining handle assembly element 8701 . FIG. 87K illustrates carriage assembly 8732 with yoke 8712 removed to better show a rotating collar 8738.
  • carriage assembly 8732 includes a knob 8740 rotatable to drive carriage assembly 8732 along rail 8752 of rail assembly 8750.
  • Such translation of carriage assembly 8732 can be used to control insertion of a delivery device coupled to mounting assembly 8700.
  • Implementations of this disclosure may also enable rotation of the delivery device relative to carriage assembly 8732.
  • carriage assembly 8732 may include a rotating collar 8738. Rotating collar 8738 is coupled to and supported by a body 8742 of carriage assembly 8732 and is rotatable relative to body 8742 about a longitudinal axis 8744, which corresponds to a longitudinal axis of the delivery device when retained by carriage assembly 8732.
  • rotation of rotating collar 8738 may be guided by a slot 8746 or similar guide element of rotating collar 8738 that mates with a corresponding structure of body 8742 (not shown).
  • FIGS. 78A-78C illustrate rotation of delivery device 7702 within cradle 7706.
  • carriage assembly 8732 may include a rotational lock (e.g., locking knob 8739) configured to selectively lock and unlock rotating collar 8738 in position.
  • carriage assembly 8732 may be configured to facilitate discrete rotation of rotating collar 8738.
  • FIG. 87L is a detailed view of carriage assembly 8732 as presented in FIG. 87L.
  • rotating collar 8738 includes a proximal face 8741 that further includes a series of detents (e.g., detent 8743).
  • Carriage assembly 8732 may include one or more corresponding protrusions (not shown) such that as a clinician or operator rotates rotating collar 8738, rotating collar 8738 transitions between discrete rotational positions due to engagement of the protrusion with the detents.
  • Mounting assembly 8700 is intended to illustrate one example mounting structure suitable for use with delivery devices of this disclosure. This disclosure contemplates that the various components and features of mounting assembly 8700 illustrated in the figures and discussed above can be replaced or modified with one or more other alternative components.
  • arm assembly 8710 may be substituted with any other suitable articulating or non-articulating assembly capable of supporting delivery devices of this disclosure in position relative to a patient.
  • mounting assembly 8700 is illustrated as including structural elements for providing controlled insertion and rotation of delivery devices, either functionality may be omitted.
  • mounting assembly 8700 includes cam-style locking mechanisms for several components. Such locking mechanisms are generally easy and intuitive to articulate in a surgical context; however, other locking mechanisms may be used in their place.
  • yoke 8712 is illustrated in FIG. 87K as including a cam-style latching mechanism 8720; however, cam-style latching mechanism 8720 may be readily substituted with a screw-type lock, a magnetic latch, a tie down, or other suitable mechanism.
  • FIGS. 56-58 illustrate an example implementation of a delivery device 3600 according to the present disclosure and described in further detail, above.
  • delivery device 3600 generally includes a control arm assembly 3608 at distal portion 3636 of delivery device 3600.
  • Control arm assembly 3608 includes multiple control arm pairs distributed around an extension member 3606.
  • Extension member 3606 is selectively extendable and retractable relative to delivery catheter 3604 to facilitate deployment of implant 3800.
  • Each control arm pair of control arm assembly 3608 includes a proximal arm 3634 coupled to a respective distal arm 3640.
  • a control shaft disposed within delivery catheter 3604 and coupled to a proximal end of each of the proximal control arms of control arm assembly 3608 is translatable to selectively extend and retract the proximal control arms.
  • diverter 3628 directs the proximal arms in a lateral and outward direction. Due to the coupling of the distal control arms to their respective proximal control arms, this lateral extension of the proximal control arms results in similar lateral and outward movement of the distal control arms, thereby expanding control arm assembly 3608.
  • each of the control arm pairs of delivery device 3600 generally include a proximal control arm, e.g., proximal arm 3634, and a respective distal control arm, e.g., distal arm 3640. More specifically, and with reference to FIG. 58, proximal portion 3641 of distal arm 3640 is coupled to distal portion 3636 of proximal arm 3634 by a T-and-slot style joint in which a T- shaped protrusion 3637 of proximal arm 3634 is inserted through and subsequently rotated to be retained by aperture 3639 of distal arm 3640. Notably, the coupling of distal arm 3640 and proximal arm 3634 in delivery device 3600 is at or near the end of the control arms.
  • control arm coupling and arrangement of delivery device 3600 and control arm assembly 3608 results in a substantially maximum moment arm for distal arm 3640 and efficient transfer of forces applied to proximal arm 3634 (e.g., by translating the control shaft) to distal arm 3640.
  • coupling the distal end of the proximal control arms at or near the proximal ends of the distal control arms generally limits the degree to which control arm assembly 3608 may be retracted during delivery and implantation.
  • FIG. 56 illustrates delivery device 3600 in a fully collapsed and fully or near fully retracted state. Further retraction of control arm assembly 3608 into delivery catheter 3604 from the state shown in FIG. 56 generally results in interference between control arm assembly 3608 and the distal end of delivery catheter 3604, precluding further retraction.
  • control arm assembly Since the control arm assembly is a generally rigid body and protrudes from the distal end of the delivery catheter, the degree to which the control arm assembly can retract relative to the delivery catheter contributes to the general maneuverability of the implant during delivery and implantation. More specifically and all other things being relatively equal, a control arm assembly that is further retractable into the delivery catheter will reduce the non-steerable length at the distal end of the delivery device, improving the maneuverability of the distal end and, by extension, an implant coupled to the distal end. [0569] With the foregoing in mind, FIGS.
  • FIG. 88A is a proximal perspective view of a distal end 8801 of delivery device 8800 with implant 8850 coupled to control arm assembly 8802.
  • delivery catheter 8804 is shown in FIG. 88A in dashed lines and occluder and outer skirt of implant 8850 are omitted.
  • Control arm assembly 8802 is coupled to and distributed about an extension member 8806, which is selectively extendible from and retractable into delivery catheter 8804. So, for example, delivery catheter 8804 will generally be kept in a fully or near fully retracted state during delivery of the implant to minimize the unsteerable distal length of delivery device 8800.
  • extension member 8806 is extended (in conjunction with retraction of a sheath (not shown) extending about the distal end of delivery device 8800) from delivery catheter 8804, deploying implant 8850 and permitting expansion of implant 8850 prior to final positioning/orientation and placement within the valve annulus.
  • implant 8850 is coupled to control arm assembly 8802 by a first cinch line 8852 and a second cinch line 8854 that extend from a first cinch line tube 8856 and a second cinch line tube 8858, respectively, about a circumference of implant 8850.
  • Implant 8850 includes eyelets (e.g., eyelet 8859) that extend proximally through slots formed in the distal control arms of control arm assembly 8802 with each of the cinch lines routed through the eyelets on a proximal side of the control arms, e.g., as illustrated in FIG. 73B.
  • FIG. 88B is the same perspective of FIG. 88A, albeit with implant 8850 and the cinch line- related elements of delivery device 8800 removed for clarity while FIG. 88C is a side elevation view of control arm assembly 8802.
  • control arm assembly 8802 generally includes a series of control arm pairs distributed about extension member 8806.
  • control arm assembly 8802 includes six control arms pairs distributed at60-degree offsets; however, other implementations of this disclosure may include more or fewer control arm pairs with different distributions.
  • Each control arm pair includes a proximal control arm, e.g., proximal control arm 8808, coupled to a respective distal control arm, e.g., distal control arm 8810.
  • proximal control arm 8808 coupled to a respective distal control arm, e.g., distal control arm 8810.
  • coupling of proximal control arm 8808 to distal control arm 8810 may be based on a T-and-slot type coupling like the coupling arrangement discussed above in the context of FIG. 58.
  • proximal control arm 8808 includes a T- or l-shaped protrusion 8812 that is inserted through a corresponding aperture 8814 of distal control arm 8810 and rotated such that distal control arm 8810 is retained by protrusion 8812 and resulting in a coupling 8816 connecting proximal control arm 8808 and distal control arm 8810 in a hinge-like manner.
  • coupling 8816 is disposed at a location distal a proximal end 8818 of distal control arm 8810 such that proximal end 8818 extends beyond coupling 8816 and forms a cantilevered section 8820 of distal control arm 8810.
  • the proximal control arm of each control arm pair of control arm assembly 8802 may be coupled to or driveable by a control shaft 8824 disposed within delivery catheter 8804. More specifically, as delivery catheter 8804 is translated distally, the proximal control arms are made to extend distally and radially outward (e.g., due to being directed outwardly by a diverter 8826). As the proximal control arms extend radially outward, they push the distal control arms outward as well, thereby expanding control arm assembly 8802.
  • control arm assembly 8802 Conversely, if control arm assembly 8802 is in an expanded state and control shaft 8824 is proximally translated, the proximal control arms of control arm assembly 8802 are retracted and radially collapsed, resulting in corresponding radially collapse of the distal control arms to which the proximal control arms are coupled.
  • L3 may be based on a relationship to L2.
  • L3 may be positioned at a location that is approximately within a central two-thirds of L2.
  • L3 may be from and including about 40% to and including about 90% of L2.
  • L3 may be about 75% of L2.
  • each of the distal control arms may include various curved sections such that the distal control arms generally conform to other elements of delivery device 8800 when the distal control arms are in a collapsed state.
  • distal control arm 8810 includes each of a distal bend 8828, a medial bend 8830, and a proximal bend 8832 adapted to conform distal control arm 8810 to extension member 8806 and delivery catheter 8804.
  • FIG. 89 is a perspective view of delivery device 8800 with control arm assembly 8802 in a collapsed state, as shown, distal control arm 8810 is coupled to proximal control arm 8808 and is shaped to generally conform to extension member 8806 and delivery catheter 8804. More specifically, distal bend 8828 of distal control arm 8810 directs a first portion of distal control arm 8810 toward and along extension member 8806. Medial bend 8830 then directs a medial section of distal control arm 8810 radially outward and around a tip 8834 of delivery catheter 8804. Finally, proximal bend 8832 redirects distal control arm 8810 radially inward toward or parallel to delivery catheter 8804.
  • distal control arm 8810 results in a shape of distal control arm 8810 that generally conforms to the distal end of the various components of delivery device 8800.
  • shape of distal control arm 8810 enables retraction of control arm assembly 8802 such that a proximal extend of control arm assembly 8802 is positioned proximally beyond a distal end of delivery catheter 8804, reducing the non-steerable length of delivery catheter 8804.
  • the curved shape of distal control arm 8810 also results in a bulbous shape, particularly when sheathed, that is readily navigable through physiological lumens of the patient.
  • FIG. 90 is a block diagram illustrating a method 9000 for implanting an implant using delivery device, each of the implant and delivery device according to various aspects of this disclosure.
  • the implant and the delivery device are prepared for the implantation process.
  • preparation of the implant on the delivery device includes coupling the implant to a distal end of the delivery device, inserting the implant into a sheath/delivery catheter of the delivery device, and mounting the delivery device within the operating theater.
  • FIG. 59 illustrates an alternative implementation in which cinch lines are routed through rings coupled to each of control arms of the control arm assembly and the implant frame such that cinch lines run through the rings similarly couples the implant to the control arm assembly.
  • the delivery device may be coupled to a mount assembly, such as the mount assembly described above in the context of FIGS. 87A-87N.
  • preparation of the implant and delivery device may also include preparation of the mounting assembly on which the delivery device is supported, such as by sterilizing and/or applying a sterile drape to the mounting assembly prior to coupling the delivery device to the mounting assembly.
  • Step 9006 includes retracting the sheath extending around the distal end of the delivery device, including the implant, to facilitate subsequent deployment of the implant.
  • retracting of the sheath may include manipulating a corresponding control of the delivery device handle assembly to proximally translate the sheath relative to the delivery catheter, thereby exposing the distal end of the delivery device and the implant.
  • Step 9008 includes deploying the implant.
  • Deploying the implant generally refers to the process of clearing the implant from the sheath and the distal end of the delivery catheter such that the implant can be freely expanded, collapsed, and positioned for implantation.
  • Deploying the implant may further include expanding the implant following clearance of the sheath and the delivery catheter.
  • expansion of the implant may be performed by rotation of an expansion control, e.g., a rotatable knob, of the handle assembly.
  • expansion is achieved by actuation (e.g., rotation) of the expansion control, which results in simultaneous proximal translation of a control arm shaft and corresponding payout of the cinch lines coupling the control arm assembly to the implant.
  • Proximal translation of the control arm shaft causes the control arm pairs of the control arm assembly to expand laterally.
  • expansion of the control arm assembly drives and/or permits natural expansion of the implant into an expanded state.
  • payout of the cinch lines is generally coordinated by the handle assembly such that the cinch lines are maintained in tension as the implant expands. Doing so improves the uniformity with which the implant expands while improving the responsiveness of the implant to actuation of the expansion controls.
  • Step 9010 includes retracting/de-extending the implant relative to the delivery catheter following at least partial expansion of the implant in step 9008.
  • retraction of the implant relative to the delivery catheter reduces the non-steerable length at the distal end of the delivery device. With less non-steerable length, the implant can be more readily and accurately manipulated within the atrium to facilitate proper alignment of the implant with the valve annulus.
  • the retraction of step 9010 may be performed by reversing the extension mechanism discussed above in the context of step 9008. So, for example, the extension control (e.g., the rotatable knob corresponding to extension) of the handle assembly may be actuated in an opposite direction to proximally retract the shuttle of the handle assembly. Doing so also retracts the extension shaft, thereby retracting the now-expanded implant relative to the delivery catheter.
  • the extension control e.g., the rotatable knob corresponding to extension
  • Step 9012 includes positioning the implant for final implantation.
  • positioning may include aligning or approximately aligning a longitudinal axis of the implant with a valve axis normal to the valve annulus.
  • Positioning the implant may further include adjusting the height of the implant relative to the valve annulus such that an occluder of the implant is positioned to interact with or otherwise contact the native leaflets of the patient valve.
  • Positioning the implant may include additional expanding, collapsing, and/or moving of the implant to achieve proper positioning of the implant relative to the valve annulus.
  • Moving of the implant may include, without limitation, one or more of changing rotation and insertion of the delivery device, steering of the delivery catheter, and extending/retracting the implant relative to the delivery catheter, as described in previous steps.
  • Step 9014 includes fully expanding the implant once in position for implantation.
  • expanding the implant generally includes operating an expansion control of the handle assembly that simultaneously expands the control arm assembly to which the implant is coupled and pays out the cinch line extending around the implant.
  • the implant is made to interfere with and engage cardiac tissue.
  • the implant may include outwardly protruding prongs or tines shaped and positioned to engage tissue adjacent the valve during the expansion process.
  • Step 9016 includes releasing the implant from the delivery device by decoupling the implant from the control arm assembly of the delivery device.
  • a full description of an example release process and corresponding handle mechanisms for achieving release of the implant are described above in the context of FIGS. 83A-86D.
  • certain release processes include coordinate release and retraction of the cinch lines coupling the implant to the control arm assembly.
  • the handle assembly includes a control element (e.g., a rotating ring) that, when actuated first pulls one or more retention members that pin the cinch lines extending around the implant in position. Further rotation of the control element then initiates pulling of the cinch lines into the delivery catheter, thereby decoupling the control arm assembly and the implant.
  • a delivery tool for an implantable medical device including a handle body; a threaded shaft extending within the handle body; a shuttle threadedly engaged with the threaded shaft and configured to translate along the threaded shaft in response to rotation of the threaded shaft; a gear assembly driveable by rotating the threaded shaft; a spool coupled to the gear assembly such that the spool is rotatable in response to rotation of the threaded shaft and simultaneously with translation of the shuttle; a control arm shaft coupled to the shuttle and extending distally from the handle body, the control arm shaft translatable by translating the shuttle; and a control arm assembly coupled to a distal end of the control arm shaft, wherein the control arm assembly is laterally expandable in response to translation of the control arm shaft.
  • Aspect 1-2 The delivery tool of Aspect 1-1 further including an extension member extending distally relative to the distal end of the control arm shaft, wherein the control arm assembly further includes: a proximal control arm coupled to a distal end of the control arm assembly; and a distal control arm, wherein: a proximal end of the distal control arm is coupled to the proximal control arm at a coupling location, and a distal end of the distal control arm is coupled to a distal end of the extension member.
  • Aspect 1-10 The delivery tool of Aspect 1-8 further including a first user input actuatable to rotate the first threaded shaft and a second user input actuatable to rotate the second threaded shaft.
  • Aspect 4-7 The delivery tool of Aspect 4-6, wherein the distal extension tube section includes a plurality of longitudinal cuts extending along the distal extension tube section and perpendicular to the first plane.
  • a cardiac valve repair implant including: a central occluder; a frame extending about a central longitudinal axis from the central occluder and self-biasing from a collapsed state to an expanded state, the frame including: an inner frame portion supporting the central occluder; a plurality of spokes extending proximally from the central portion and forming a circumference about the central longitudinal axis; and expandable outer cells disposed between adjacent spokes of the plurality of spokes; and an outer sheet supported on a proximal portion of the frame and extending circumferentially about the proximal portion of the frame, wherein when the frame is in the expanded state, the outer sheet and the central occluder define an annulus between the outer sheet and the central occluder centered about the central longitudinal axis.
  • Aspect 5-3 The cardiac valve repair implant of Aspect 5-1, wherein a distal edge of the outer sheet is circular about the central longitudinal axis.
  • Aspect 6-3 The cardiac valve repair implant of Aspect 6-1 , wherein a spoke of the plurality of spokes defines a slot through which an eyelet of the plurality of eyelets extends.
  • Aspect 7-2 The cardiac valve repair implant of Aspect 7-1 wherein the central occluder has a distally concave shape.
  • Aspect 7-5 The cardiac valve repair implant of Aspect 7-4, wherein the second sheet is bonded to the first sheet by a liquid bonding material applied to the second sheet.
  • Aspect 7-6 The cardiac valve repair implant of Aspect 7-1 , wherein the first sheet is formed from expanded polytetrafluoroethylene (ePTFE).
  • ePTFE expanded polytetrafluoroethylene
  • Aspect 7-10 The cardiac valve repair implant of Aspect 7-9, wherein the polyurethane compound including a siloxane segmented polyurethane and a polymer precursor.
  • Aspect 7-13 The cardiac valve repair implant of Aspect 7-12, wherein the proximal cap including a frame element and a proximal sheet coupled to the frame element.
  • Aspect 7-14 The cardiac valve repair implant of Aspect 7-13, wherein the proximal sheet is formed from a porous material.
  • Aspect 7-17 The cardiac valve repair implant of Aspect 7-16, wherein the internal volume is filled with aa solid or expandable material.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Un dispositif de pose pour des implants de réparation de valvule cardiaque comprend un cathéter de pose et un élément d'extension faisant saillie à partir d'une extrémité distale du cathéter de pose. Le dispositif de pose comprend en outre un ensemble bras de commande ayant des paires de bras de commande. Chaque paire comprend un bras de commande proximal pouvant être entraîné à partir d'un ensemble poignée du dispositif de pose et un bras distal accouplé à une extrémité distale du bras de commande proximal et à une extrémité distale de l'élément d'extension. L'entraînement proximal de chacun des bras de commande proximaux de l'ensemble bras de commande entraîne l'expansion de l'ensemble bras de commande et l'expansion correspondante d'un implant de réparation de valvule cardiaque couplé à l'ensemble bras de commande.
EP23820382.2A 2022-06-06 2023-06-06 Système et procédé de réparation de valvule cardiaque Pending EP4536148A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263349222P 2022-06-06 2022-06-06
PCT/US2023/024623 WO2023239751A1 (fr) 2022-06-06 2023-06-06 Système et procédé de réparation de valvule cardiaque

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EP (1) EP4536148A1 (fr)
JP (1) JP2025519429A (fr)
KR (1) KR20250033211A (fr)
CN (1) CN119584940A (fr)
WO (1) WO2023239751A1 (fr)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN119097474B (zh) * 2024-08-29 2025-09-26 应脉医疗科技(上海)有限公司 输送装置
CN120788785B (zh) * 2025-09-08 2026-01-06 成都赛拉诺医疗科技股份有限公司 一种用于二尖瓣置换中的瓣膜支架

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7556646B2 (en) * 2001-09-13 2009-07-07 Edwards Lifesciences Corporation Methods and apparatuses for deploying minimally-invasive heart valves
US20080300462A1 (en) * 2007-05-31 2008-12-04 Boston Scientific Scimed, Inc. Active controlled bending in medical devices
US20120053680A1 (en) * 2010-08-24 2012-03-01 Bolling Steven F Reconfiguring Heart Features
US8486009B2 (en) * 2011-06-20 2013-07-16 Hue-Teh Shih Systems and methods for steering catheters
AU2017363069B2 (en) * 2016-11-18 2020-08-20 Cephea Valve Technologies, Inc. Cardiac valve delivery devices and systems
EP3658074A1 (fr) * 2017-07-28 2020-06-03 Boston Scientific Scimed Inc. Poignée à mécanisme d'entraînement direct
KR102217719B1 (ko) * 2020-04-14 2021-02-18 힐로 이노베이션 척추용 인공 디스크 및 이를 이용한 인공 디스크 삽입방법
US11266502B1 (en) * 2020-12-14 2022-03-08 Versa Vascular Inc. System and method for cardiac valve repair

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CN119584940A (zh) 2025-03-07
KR20250033211A (ko) 2025-03-07
WO2023239751A1 (fr) 2023-12-14
JP2025519429A (ja) 2025-06-26

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