# US 12,109,116 B2 · Coaptation enhancement implant, system, and method > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,109,116 B2 - Document ID: US12109116B2 - Status: Granted - Kind: B2 - Application number: 18/296,043 - Filed: 2023-04-05 - Published: 2023-09-21 - Granted: 2024-10-08 - Earliest claimed: 2011-01-28 - Assignees: Polares Medical Inc. - Applicants: Polares Medical Inc. - Inventors: Alexander Khairkhahan; Michael D. Lesh - Web page: https://patentgrep.com/patent/US12109116B2 ## CPC - A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition} - 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 17/064: Surgical staples, {i.e. penetrating the tissue} - 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 2/2454: {Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses} - A61F 2/2466: {Delivery devices therefor} - A61B 17/12122: {within the heart (for closing a cardiac septal defect A61B17/0057)} - A61B 17/12172: {having a pre-set deployed three-dimensional shape (methods of manufacturing A61B2017/00526)} - A61B 2017/00867: {shape memory effect} - A61B 2017/0412: {having anchoring barbs or pins extending outwardly from suture anchor body} - A61B 2017/0448: {Additional elements on or within the anchor} - A61B 2017/0464: {for soft tissue} - A61B 2017/048: {for reducing heart wall tension, e.g. sutures with a pad on each extremity} - A61B 2017/0649: {Coils or spirals} - A61F 2/2457: {Chordae tendineae prostheses} - 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 Implants, implant systems, and methods for treatment of mitral valve regurgitation and other valve diseases generally include a coaptation assist body which remains within the blood flow path as the leaflets of the valve move, the valve bodies often being relatively thin, elongate (along the blood flow path), and/or conformable structures which extend laterally from commissure to commissure, allowing the native leaflets to engage and seal against the large, opposed surfaces on either side of the valve body during the heart cycle phase when the ventricle contracts to empty that chamber of blood, and allows blood to pass around the valve body so that blood flows from the atrium to the ventricle during the filling phase of the heart cycle. Separate deployment of independent anchors near each of the commissures may facilitate positioning and support of an exemplary triangular valve body, with a third anchor being deployed in the ventricle. An outer surface of the valve body may accommodate tissue ingrowth or endothelialization, while a fluid-absorbing matrix can swell after introduction into the heart. The valve body shape may be selected after an anchor has been deployed, and catheter-based deployment systems may have a desirable low profile. ## Claims ### Claim 1 A coaptation assist system for treating mal-coaptation of a heart valve of a heart, the heart valve comprising a valve annulus and a first leaflet and a second leaflet, the coaptation assist system comprising: a coaptation assist body comprising a first coaptation surface and a second surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body and longitudinally between an upstream end and a downstream end of the coaptation assist body; a primary anchor configured to secure the coaptation body to the valve annulus of the heart; and one or more secondary anchors spaced apart laterally from the primary anchor. ### Claim 2 (depends on 1) The system of claim 1, wherein the primary anchor comprises a helical shape. ### Claim 3 (depends on 1) The system of claim 1, wherein each secondary anchor comprises a helical shape. ### Claim 4 (depends on 1) The system of claim 1, wherein the one or more secondary anchors comprise two secondary anchors. ### Claim 5 (depends on 4) The system of claim 4, wherein the two secondary anchors are circumferentially separated around the valve annulus. ### Claim 6 (depends on 1) The system of claim 1, wherein the primary anchor is configured to screw into heart tissue. ### Claim 7 (depends on 1) The system of claim 1, wherein each secondary anchor is configured to screw into heart tissue. ### Claim 8 (depends on 1) The system of claim 1, wherein the coaptation assist body comprises a curvature. ### Claim 9 (depends on 1) The system of claim 1, wherein the coaptation assist body is configured to be positioned within the heart such that the first coaptation surface coapts with the first leaflet. ### Claim 10 A coaptation assist system for treating mal-coaptation of a heart valve of a heart, the heart valve comprising a valve annulus and a first leaflet and a second leaflet, the coaptation assist system comprising: a coaptation assist body comprising a first coaptation surface and a second surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body and longitudinally between an upstream end and a downstream end of the coaptation assist body; a primary anchor configured to anchor the coaptation body to the valve annulus of the heart; and two secondary anchors configured to be positioned on opposite sides of the primary anchor. ### Claim 11 (depends on 10) The system of claim 10, wherein the primary anchor and each secondary anchor comprise a tissue penetrating helical body. ### Claim 12 (depends on 10) The system of claim 10, wherein the coaptation assist body is configured to be coupleable in vivo within the heart valve to be treated. ### Claim 13 (depends on 10) The system of claim 10, further comprising a catheter system through which the coaptation assist device is configured to be deployed within the heart valve. ### Claim 14 (depends on 10) The system of claim 10, wherein the two secondary anchors are configured to facilitate positioning and support the coaptation assist body. ### Claim 15 (depends on 10) The system of claim 10, wherein the first coaptation surface of the coaptation assist body is configured to be positioned to coapt with the first leaflet of the heart valve. ### Claim 16 A coaptation assist system for treating mal-coaptation of a heart valve of a heart, the heart valve comprising a valve annulus and a first leaflet and a second leaflet, the coaptation assist system comprising: a coaptation assist body comprising a first coaptation surface and a second surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body and longitudinally between an upstream end and a downstream end of the coaptation assist body; a primary anchor deployable to anchor the coaptation body to the valve annulus of the heart; and a secondary anchor, wherein the primary anchor and the secondary anchor comprise helical body configured to be driven into tissue, wherein the primary anchor and the secondary anchor are separately deployable. ### Claim 17 (depends on 16) The system of claim 16, wherein the primary anchor and the secondary anchor are configured to be rotated to engage tissue. ### Claim 18 (depends on 16) The system of claim 16, wherein the secondary anchor comprises a helical anchor. ### Claim 19 (depends on 16) The system of claim 16, further comprising a catheter system. ### Claim 20 (depends on 16) The system of claim 16, wherein the coaptation assist body is configured to be positioned between the first leaflet and the second leaflet.