# US 10,500,048 B2 · Mitral valve implants for the treatment of valvular regurgitation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,500,048 B2 - Document ID: US10500048B2 - Status: Granted - Kind: B2 - Application number: 14/742,199 - Filed: 2015-06-17 - Published: 2015-12-24 - Granted: 2019-12-10 - Earliest claimed: 2014-06-18 - Assignees: Polares Medical Inc. - Applicants: Polares Medical Inc. - Inventors: Alexander K. Khairkhahan; Michael D. Lesh - Web page: https://patentgrep.com/patent/US10500048B2 ## CPC - A61F 2/2466: {Delivery devices therefor} - A61B 17/0401: {Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors (A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811)} - A61B 17/068: Surgical staplers {, e.g. containing multiple staples or clamps}({staplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105;} for performing anastomosis A61B17/115; {staplers in general B25C5/00}) - A61F 2/2442: {Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve} - A61F 2/2454: {Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses} - A61B 2017/00323: {Cables or rods} - A61B 2017/0053: {Loading magazines or sutures into applying tools} - A61B 2017/0409: {Instruments for applying suture anchors} - A61B 2017/0417: {T-fasteners} - A61B 2017/0441: {the shaft being a rigid coil or spiral} - A61B 2017/0461: {with features cooperating with special features on the suture, e.g. protrusions on the suture} - A61B 2017/0464: {for soft tissue} - A61B 2017/06052: {Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle} - A61B 2017/0641: {having at least three legs as part of one single body} - A61B 2017/0649: {Coils or spirals} - A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol - 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 (dental prosthetics A61C) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract The invention relates in some aspects to a device for use in the transcatheter treatment of mitral valve regurgitation, including steerable guidewires, implantable coaptation assistance devices, anchoring systems for attaching a ventricular projection of an implantable coaptation device, a kit, and methods of using an implantable coaptation assistance device among other methods. ## Claims ### Claim 1 An anchoring system comprising: an implant comprising a hub and a plurality of struts extending circumferentially around the hub, wherein the implant comprises a proximal end and a distal end, wherein the hub is located proximally, wherein at least one strut of the plurality of struts extends from the hub to the distal end of the implant, wherein the implant comprises a wider proximal end than distal end; and a helical tissue anchor comprising a proximal end and a sharpened distal tip, the proximal end of the helical tissue anchor located proximal to the annular hub, the hub dimensioned to receive the helical tissue anchor therethrough, wherein a portion of the helical tissue anchor is configured to be passed through a distal end of the hub and toward the distal end of the implant to drive the sharpened distal tip of the helical tissue anchor into tissue; wherein the helical tissue anchor comprises a first engagement structure, the first engagement structure for releasable engagement of a torque shaft; wherein the torque shaft comprises a second engagement structure for engaging the helical tissue anchor; wherein the torque shaft is configured to rotate the helical tissue anchor relative to the hub and into tissue, wherein the helical tissue anchor is configured to secure the implant to tissue. ### Claim 2 (depends on 1) The anchoring system of claim 1, wherein the helical tissue anchor comprises a shoulder, the shoulder comprising the first engagement structure. ### Claim 3 (depends on 1) The anchoring system of claim 1, wherein the first engagement structure is an aperture and the second engagement structure is a projection. ### Claim 4 (depends on 3) The anchoring system of claim 3, wherein the projection is laterally moveable into and out of the aperture. ### Claim 5 (depends on 3) The anchoring system of claim 3, wherein the projection is laterally moveable into and out of the aperture in response to axial movement of an elongate element within the torque shaft. ### Claim 6 (depends on 1) The anchoring system of claim 1, wherein the hub comprises a cross-pin, wherein the cross-pin is configured to provide a site about which a helical structure of the helical tissue anchor is configured to wrap around. ### Claim 7 (depends on 1) The anchoring system of claim 1, wherein the helical tissue anchor comprises fluoroscopic markers. ### Claim 8 (depends on 1) The anchoring system of claim 1, wherein the implant comprises a coaptation assistance body, wherein the coaptation assist body comprises a first coaptation surface and a second coaptation surface, opposed to the first coaptation surface, wherein the first coaptation surface and the second coaptation surface are bounded by a first lateral edge, a second lateral edge, an inferior edge, and a superior edge. ### Claim 9 (depends on 1) The anchoring system of claim 1, wherein the plurality of struts comprise a shape memory material. ### Claim 10 (depends on 1) The anchoring system of claim 1, wherein the implant comprises one or more passive hooks. ### Claim 11 (depends on 1) The anchoring system of claim 1, further comprising one or more helical commissure anchors. ### Claim 12 (depends on 1) The anchoring system of claim 1, further comprising a delivery catheter having multiple lumens, wherein the lumens are configured to early individual torque shafts. ### Claim 13 (depends on 1) The anchoring system of claim 1, further comprising a steerable catheter, wherein the implant is adapted to follow the path of the steerable catheter. ### Claim 14 (depends on 1) The anchoring system of claim 1, further comprising the torque shaft. ### Claim 15 (depends on 1) The anchoring system of claim 1, wherein the hub is configured to be positioned near an annulus of a heart valve, wherein the helical tissue anchor is configured to engage the annulus. ### Claim 16 (depends on 1) The anchoring system of claim 1, wherein the second engagement structure is configured to be deflected to engage the helical tissue anchor. ### Claim 17 An anchoring system comprising: an implant comprising an annular hub and a plurality of struts extending circumferentially around the annular hub, wherein the annular hub is located near a proximal end of the implant, wherein at least one strut of the plurality of struts extends from the annular hub to a distal end of the implant, wherein the implant generally tapers in width from the proximal end to the distal end; a helical tissue anchor comprising a proximal end and a distal tip, wherein the proximal end of the helical tissue anchor is located proximal to the annular hub, wherein the helical tissue is configured to be rotated such that the distal tip extends distally from the annular hub toward the distal end of the implant to engage tissue located distal to the annular hub; a first engagement structure on the helical tissue anchor, the first engagement structure for releasable engagement of a torque shaft; wherein the torque shaft comprises a second engagement structure for engaging the helical tissue anchor; wherein the torque shaft is configured to rotate to drive the sharpened distal tip of the helical tissue anchor into tissue and secure the implant to tissue. ### Claim 18 (depends on 17) The anchoring system of claim 17, wherein the implant comprises a coaptation assistance body, wherein the coaptation assist body comprises a first coaptation surface and a second coaptation surface, opposed to the first coaptation surface, wherein the first coaptation surface and the second coaptation surface are bounded by a first lateral edge, a second lateral edge, an inferior edge, and a superior edge. ### Claim 19 (depends on 17) The anchoring system of claim 17, herein the plurality of struts comprise a shape memory material. ### Claim 20 (depends on 17) The anchoring system of claim 17, wherein the second engagement structure is configured to be deflected to engage the helical tissue anchor. ### Claim 21 An anchoring system comprising: an implant comprising a hub and a plurality of struts extending around the hub and integrally formed with the hub, wherein the hub is located proximally on the implant and the plurality of struts extend laterally and distally from the hub to than a frame of the implant, wherein the implant is bounded by a proximal edge, a distal edge, a first lateral edge, and a second lateral edge, wherein a length of the proximal edge greater than a length of the distal edge; and a helical tissue anchor comprising a proximal end and a distal end, the proximal end of the helical tissue anchor located proximal to the hub, the hub dimensioned to receive a portion of the helical tissue anchor, wherein the distal end of the helical tissue anchor is configured to extend distally from the hub to engage tissue located distal to the hub; wherein the helical tissue anchor comprises a first engagement structure, the first engagement structure for releasable engagement of a torque shaft; wherein the torque shaft comprises a second engagement structure for engaging the helical tissue anchor; wherein the torque shaft is configured to rotate the helical tissue anchor relative to the hub and into tissue, wherein the helical tissue anchor is configured to secure the implant to tissue.