# US 11,439,501 B2 · Device for securing heart valve leaflets > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,439,501 B2 - Document ID: US11439501B2 - Status: Granted - Kind: B2 - Application number: 16/479,584 - Filed: 2018-01-24 - Published: 2019-12-05 - Granted: 2022-09-13 - Earliest claimed: 2017-01-25 - Assignees: Cedars-Sinai Medical Center - Applicants: Cedars-Sinai Medical Center - Inventors: Robert James Siegel; Lawrence Eric Ong; Niclas Henning Zieger - Web page: https://patentgrep.com/patent/US11439501B2 ## CPC - A61B 17/1285: {for minimally invasive surgery} - A61F 2/2403: {with pivoting rigid closure members (check valves with hinged closure members in general F16K15/03)} - A61B 17/122: Clamps or clips, e.g. for the umbilical cord {(for the vas deferens A61F6/206)} - A61F 2/2418: {Scaffolds therefor, e.g. support stents} - A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation} - A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition} - A61F 2/2466: {Delivery devices therefor} - A61B 17/0482: {Needle or suture guides (guides for drills, pins or wire A61B17/17; guides for puncturing needles A61B17/3403)} - A61B 17/1227: {Spring clips} - A61B 2017/00243: {cardiac} - A61B 2017/00783: {Valvuloplasty} - A61B 2017/00991: {Telescopic means} - A61B 2017/0474: {Knot pushers} - A61B 2017/0496: {for tensioning sutures} - A61B 2090/037: {with a frangible part, e.g. by reduced diameter} - A61F 2220/0025: Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements - A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable - A61F 2220/0091: connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type - A61F 2230/0013: Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped - A61F 2230/0095: Saddle-shaped - A61F 2250/0071: breakable or frangible - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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) ## Abstract A heart valve prosthesis is provided that includes a first member and a second member. The first member comprises a first central portion to be disposed adjacent to a line of coaptation on a first side of two adjacent heart leaflets and peripheral portions to be placed into direct contact with the two adjacent heart leaflets. The second member is separate from or can be separable from the first member, for example during delivery. The second member has a central portion and peripheral portions configured to be placed into direct contact with a second side of the two adjacent heart leaflets. ## Claims ### Claim 1 A heart valve prosthesis, comprising: a first member comprising a central portion to be disposed adjacent to a line of coaptation on a first side of two adjacent heart leaflets, a first peripheral portion, and a second peripheral portion disposed on an opposite side of the central portion from the first peripheral portion, the first peripheral portion and the second peripheral portion configured to be placed into direct contact with the two adjacent heart leaflets; and a second member separate from the first member, the second member comprising a central portion, a first peripheral portion, and a second peripheral portion disposed on an opposite side of the central portion of the second member from the first peripheral portion, the first peripheral portion and the second peripheral portion of the second member configured to be placed into direct contact with a second side of the two adjacent heart leaflets; wherein in a delivery state the first and second members are in a first aligned delivery configuration in which the second peripheral portion of the first member is disposed over the first peripheral portion of the second member and the first peripheral portion of the first member is disposed distal to the first peripheral portion of the second member; and wherein the first and second members transition to a second aligned deployed configuration in which the first peripheral portion of the first member is disposed over the first peripheral portion of the second member and the second peripheral portion of the first member is disposed over the second peripheral portion of the second member. ### Claim 2 (depends on 1) The heart valve prosthesis of claim 1, wherein the first member comprises a first hinge portion and one of the peripheral portions of the second member comprises a second hinge portion. ### Claim 3 (depends on 2) The heart valve prosthesis of claim 2, wherein the second hinge portion is disposed at an end of the second member. ### Claim 4 (depends on 1) The heart valve prosthesis of claim 1, wherein the first member comprises a connector passage having a first segment on a non-tissue facing side and a second segment extending about a surface of a hinge portion of the first member, the surface disposed away from an axis of rotation of the first member. ### Claim 5 (depends on 1) An assembly comprising the heart valve prosthesis of claim 1 and a U-shaped suture having first and second free ends and a U-shaped middle portion disposed about the first member. ### Claim 6 (depends on 1) The heart valve prosthesis of claim 1, further comprising a connector configured to be disposed across a gap between the first member and the second member to secure the central portion of the first member to the central portion of the second member. ### Claim 7 (depends on 6) The heart valve prosthesis of claim 6, wherein the connector comprises a suture. ### Claim 8 (depends on 6) The heart valve prosthesis of claim 6, wherein the connector comprises a clip body insertable into a recess in the second member. ### Claim 9 (depends on 8) The heart valve prosthesis of claim 8, wherein the clip comprises a proximal body and at least one member configured to be disposed across a tissue facing side of the first member and a tissue facing side of the second member, the proximal body engaging the second member and the at least one member engaging the first member. ### Claim 10 (depends on 8) The heart valve prosthesis of claim 8, wherein the clip comprises a saddle-shaped body configured to be received in a recess of the second member, the recess being disposed on the side opposite the tissue-engaging side of the second member. ### Claim 11 A heart valve prosthesis, comprising: a first member comprising a first central portion to be disposed adjacent to a line of coaptation on a first side of two adjacent heart leaflets and peripheral portions to be placed into direct contact with the two adjacent heart leaflets; a second member separate from the first member, the second member comprising a central portion and peripheral portions configured to be placed into direct contact with a second side of the two adjacent heart leaflets; wherein the first member comprises a first hinge portion having a concave surface disposed in the first central portion and a concave recess disposed in one of the peripheral portions, and wherein one of the peripheral portions of the second member comprises a second hinge portion having a convex surface; and wherein the first and second hinge portions are in contact in a delivery configuration and at least a portion of the convex surface of the second member is in contact with the concave surface of the first member to control movement of the first member relative to the second member about the second hinge portion, the first and second hinge portions disengageable to provide a deployed configuration for trapping one or more leaflets, the convex surface of the second member being aligned with and/or received in the concave recess of the first member in the deployed configuration for trapping. ### Claim 12 (depends on 11) A system for treating heart valve insufficiency, comprising: the heart valve prosthesis of claim 11, wherein: the first member comprises a distal body comprising the first hinge portion; the second member comprises a proximal body comprising the second hinge portion; and a connector configured to secure the distal body to the proximal body; a catheter assembly comprising: an elongate outer tubular member comprising a lumen having an inner diameter; a first elongate inner member comprising a distal face mating with the connector; and a second elongate inner member circumferentially surrounding the first elongate inner member and comprising a distal portion mating with an end face of the proximal body. ### Claim 13 (depends on 12) The system of claim 12, further comprising a tension member that passes through a through-hole of the distal body. ### Claim 14 (depends on 13) The system of claim 13, wherein the suture passes between a tissue-engaging surface of the distal body and a tissue-engaging surface of the proximal body. ### Claim 15 (depends on 14) The system of claim 14, wherein the tension member passes across a surface opposite the tissue-engaging surface of the distal body. ### Claim 16 (depends on 11) A loading capsule system, comprising: the valve prosthesis of claim 11; and a capsule body comprising a distal zone configured to engage a delivery catheter and a prosthesis loading zone configured to receive the first member and the second member of the heart valve prosthesis in the delivery configuration, the capsule body further comprising a proximal end, a distal end, and a lumen extending from the proximal end of the capsule body to the distal end of the capsule body. ### Claim 17 (depends on 16) The loading capsule system of claim 16, further comprising a seal disposed in the lumen configured to sealingly engage a component of the heart valve prosthesis and/or of a delivery system. ### Claim 18 (depends on 16) The loading capsule system of claim 16, wherein the distal zone comprises a tapered surface configured to mate with a guide catheter. ### Claim 19 (depends on 16) The loading capsule system of claim 16, wherein the the first and second members are coupled in a delivery configuration having a delivery profile corresponding to the lumen of the loading capsule. ### Claim 20 (depends on 16) The loading capsule system of claim 16, further comprising a control body engaged with a peripheral edge of the second member, the control body and the second member having a delivery profile corresponding to the lumen of the loading capsule. ### Claim 21 (depends on 20) The system of claim 20, further comprising a guide catheter, a distal zone of the loading capsule disposed through a recess of the guide catheter such that the lumen of the loading capsule is in communication with a lumen of the guide catheter.