# US 12,059,343 B2 · Prosthetic valves and related inventions > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,059,343 B2 - Document ID: US12059343B2 - Status: Granted - Kind: B2 - Application number: 17/832,596 - Filed: 2022-06-04 - Published: 2022-10-13 - Granted: 2024-08-13 - Earliest claimed: 2016-06-16 - Assignees: Tendyne Holdings, Inc. - Applicants: Tendyne Holdings, Inc. - Inventors: Robert Vidlund; Kemal Schankereli; Lucian Lozonschi; Georg Lutter - Web page: https://patentgrep.com/patent/US12059343B2 ## CPC - A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves} - A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)} - A61F 2/2418: {Scaffolds therefor, e.g. support stents} - A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation} - A61L 27/34: Macromolecular materials - A61L 27/3625: {Vascular tissue, e.g. heart valves} - A61L 27/3629: {Intestinal tissue, e.g. small intestinal submucosa} - A61L 33/0011: {Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate} - C08L 67/04: Polyesters derived from hydroxycarboxylic acids, e.g. lactones (C08L67/06 takes precedence) - 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 17/0644: {penetrating the tissue, deformable to closed position} - A61B 2017/0404: {Buttons} - A61F 2/2436: {Deployment by retracting a sheath} - A61F 2/2457: {Chordae tendineae prostheses} - A61F 2210/0004: bioabsorbable - A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol - A61F 2220/0008: Fixation appliances for connecting prostheses to the body - A61F 2220/005: using adhesives - A61F 2220/0058: soldered or brazed or welded - 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 2230/0034: D-shaped - A61F 2230/005: Rosette-shaped, e.g. star-shaped - A61F 2230/0054: V-shaped - A61F 2230/0067: conical - A61F 2230/0091: helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section - A61F 2310/00023: Titanium or titanium-based alloys, e.g. Ti-Ni alloys - A61F 2310/00077: Copper or Cu-based alloys - A61L 2400/16: Materials with shape-memory or superelastic properties - A61L 2430/20: for reconstruction of the heart, e.g. heart valves - 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) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve. ## Claims ### Claim 1 A method of replacing a native mitral valve with a prosthetic heart valve, the method comprising: advancing a delivery catheter to a left atrium of a patient, the delivery catheter containing the prosthetic heart valve in a collapsed condition during the advancing, the prosthetic heart valve including a stent, a leaflet assembly supported by the stent, and a flexible gasket coupled to a ventricular end of the stent and positioned around an exterior of the stent; while the delivery catheter is in the left atrium of the patient, deploying the gasket from the delivery catheter; and after deploying the gasket from the delivery catheter, advancing the prosthetic heart valve through the native mitral valve until the deployed gasket contacts an annulus of the native mitral valve to stop the prosthetic heart valve from traveling further through the native mitral valve, wherein the gasket is coupled to the stent at a joint at or near the ventricular end of the stent. ### Claim 2 (depends on 1) The method of claim 1, wherein deploying the gasket includes allowing the gasket to self-expand. ### Claim 3 (depends on 2) The method of claim 2, wherein after advancing the prosthetic heart valve through the native mitral valve, the gasket provides a lateral annular compressive force against the native mitral valve annulus to immobilize the prosthetic heart valve. ### Claim 4 (depends on 3) The method of claim 3, wherein the gasket has an atrial terminus that has a diameter that is larger than a diameter of the ventricular end of the stent. ### Claim 5 (depends on 1) The method of claim 1, wherein by advancing the prosthetic heart valve through the native mitral valve until the deployed gasket contacts the native mitral valve annulus, the gasket creates a seal between the left atrium and a left ventricle of the patient. ### Claim 6 (depends on 5) The method of claim 5, wherein the gasket is at least partially covered by a stabilized tissue or a synthetic material. ### Claim 7 A method of replacing a native mitral valve with a prosthetic heart valve, the method comprising: advancing a delivery catheter to a left atrium of a patient, the delivery catheter containing the prosthetic heart valve in a collapsed condition during the advancing, the prosthetic heart valve including a stent, a leaflet assembly supported by the stent, and a flexible gasket coupled to a ventricular end of the stent and positioned around an exterior of the stent; while the delivery catheter is in the left atrium of the patient, deploying the gasket from the delivery catheter; and after deploying the gasket from the delivery catheter, advancing the prosthetic heart valve through the native mitral valve until the deployed gasket contacts an annulus of the native mitral valve to stop the prosthetic heart valve from traveling further through the native mitral valve, wherein upon advancing the prosthetic heart valve through the native mitral valve, the entire prosthetic valve is held by lateral pressure caused by forcible compression of the gasket in the native mitral valve annulus. ### Claim 8 (depends on 7) The method of claim 7, wherein the prosthetic heart valve includes a tether attached to the prosthetic heart valve and advancing the prosthetic heart valve through the native mitral valve includes pulling the tether. ### Claim 9 (depends on 1) The method of claim 1, wherein upon replacing the native mitral valve with the prosthetic heart valve, the stent extends into a left ventricle of the patient about to an edge of open leaflets of the native mitral valve. ### Claim 10 (depends on 1) The method of claim 1, wherein upon replacing the native mitral valve with the prosthetic heart valve, the stent extends approximately 25% of a distance between the native mitral valve annulus and a left ventricular apex of a heart of the patient. ### Claim 11 A method of replacing a native mitral valve with a prosthetic heart valve, the method comprising: advancing a delivery catheter to a left atrium of a patient, the delivery catheter containing the prosthetic heart valve in a collapsed condition during the advancing, the prosthetic heart valve including a stent, a leaflet assembly supported by the stent, and a flexible gasket coupled to a ventricular end of the stent and positioned around an exterior of the stent; while the delivery catheter is in the left atrium of the patient, deploying the gasket from the delivery catheter; and after deploying the gasket from the delivery catheter, advancing the prosthetic heart valve through the native mitral valve until the deployed gasket contacts an annulus of the native mitral valve to stop the prosthetic heart valve from traveling further through the native mitral valve, wherein upon replacing the native mitral valve with the prosthetic heart valve, the prosthetic heart valve sits in the native mitral valve annulus at an angle directed away from a native aortic valve of the patient so that the prosthetic heart valve does not obstruct flow through the native aortic valve. ### Claim 12 (depends on 1) The method of claim 1, wherein the gasket forms an acute angle in relation to an exterior wall of the stent. ### Claim 13 (depends on 1) The method of claim 1, wherein the gasket is formed separately from the stent. ### Claim 14 (depends on 1) The method of claim 1, wherein advancing the prosthetic heart valve through the native mitral valve causes the deployed gasket to wedge into the native mitral valve annulus. ### Claim 15 (depends on 1) The method of claim 1, wherein the stent and the gasket are both laser cut with pre-determined shapes to facilitate collapsing into the delivery catheter. ### Claim 16 (depends on 1) The method of claim 1, wherein the delivery catheter is a rigid tube. ### Claim 17 (depends on 16) The method of claim 16, wherein advancing the delivery catheter to the left atrium of the patient includes a transapical route in which the delivery catheter passes through a ventricular apex of the patient. ### Claim 18 (depends on 1) The method of claim 1, wherein the delivery catheter is a flexible catheter. ### Claim 19 (depends on 18) The method of claim 18, wherein advancing the delivery catheter to the left atrium of the patient includes a transfemoral, antegrade route in which the delivery catheter passes through an atrial septum.