# US 2016/0256268 A1 · Paravalvular leak occlusion device for self-expanding heart valves > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2016/0256268 A1 - Document ID: US20160256268A1 - Status: Published application - Kind: A1 - Application number: 15/155,451 - Filed: 2016-05-16 - Published: 2016-09-08 - Earliest claimed: 2013-03-12 - Assignees: St. Jude Medical, Cardiology Division, Inc. - Applicants: St. Jude Medical, Cardiology Division, Inc. - Inventors: Gregory James Dakin - Web page: https://patentgrep.com/patent/US20160256268A1 ## CPC - A61F 2/2418: {Scaffolds therefor, e.g. support stents} - 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)} - A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)} - A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation} - A61B 17/12118: {for positioning in conjunction with a stent} - A61F 2002/077: {having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve} - A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol - A61F 2230/0069: cylindrical - A61F 2250/0069: Sealing means - A61F 2310/00011: Metals or alloys - 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 A system for replacing native valve function includes a prosthetic heart valve having a collapsible and expandable stent, the stent having a plurality of sections, and a valve assembly disposed in the stent. The system further includes an occluder device having an expandable body having a first end and a second end, a fastener coupled to the first end of the body and to a portion of the stent at a first position adjacent a first section of the stent, and a disk coupled to the second end of the body and to a portion of the stent at a second position in a section other than the first section. ## Claims ### Claim 1 (canceled) ### Claim 2 A system for replacing native valve function, the system comprising: a prosthetic heart valve having a collapsible and expandable stent, the stent having a plurality of sections, and a valve assembly disposed in the stent; and an occluder device comprising an expandable body having a first end and a second end, a fastener coupled to the first end of the body and to a portion of the stent at a first position adjacent a first section of the stent, and a disk coupled to the second end of the body and to a portion of the stent at a second position in a section other than the first section. ### Claim 3 (depends on 2) The system of claim 2, wherein the stent includes an annulus section, a transition section, and an aortic section. ### Claim 4 (depends on 2) The system of claim 2, wherein the disk is expandable from a collapsed configuration to a relaxed configuration. ### Claim 5 (depends on 4) The system of claim 4, wherein the stent includes a plurality of cells, and the disk, in the relaxed configuration, has a size larger than a size of at least some of the cells of the stent and incapable of passing therethrough. ### Claim 6 (depends on 2) The system of claim 2, wherein the stent includes a plurality of struts and the fastener is coupled to at least one of the plurality of the struts. ### Claim 7 (depends on 2) The system of claim 2, wherein the body includes at least one of a metallic mesh or a shape-memory material. ### Claim 8 (depends on 2) The system of claim 2, wherein the body has an elliptical longitudinal cross-section. ### Claim 9 (depends on 2) The system of claim 2, wherein the body includes a metal mesh and polyester fiber intertwined with the metal mesh. ### Claim 10 (depends on 2) The system of claim 2, wherein the fastener includes a loop of wire. ### Claim 11 (depends on 2) The system of claim 2, wherein the disk is expandable and includes at least one of a metallic mesh or a shape-memory material. ### Claim 12 (depends on 2) The system of claim 2, further comprising: a connector attached to the disk for coupling to a delivery device. ### Claim 13 (depends on 2) The system of claim 2, wherein the body includes multiple segments, each segment being capable of independent radial expansion from the other segments. ### Claim 14 (depends on 2) The system of claim 2, further comprising: a delivery system including an outer sheath, an inner wire disposed within and translatable with respect to the outer sheath, and a connector attached to the inner wire, the connector being configured to couple the inner wire to the disk of the occluder device. ### Claim 15 (depends on 14) The system of claim 14, wherein the outer sheath is adapted to house the occluder device in a contracted configuration, and the outer sheath is sized to pass through a cell of the expandable stent. ### Claim 16 A method for occluding a gap between a prosthetic heart valve and adjacent body tissue, the method comprising: delivering an occluder to the heart valve, the occluder including (i) an expandable body, (ii) a fastener coupled to one end of the body, and (iii) an expandable disk coupled to another end of the body; coupling the fastener to one end of the prosthetic heart valve; and coupling the expandable disk to the prosthetic heart valve at a position spaced from the one end. ### Claim 17 (depends on 16) The method of claim 16, wherein the step of coupling the fastener includes positioning a loop around an apex of a cell at the one end of the prosthetic heart valve. ### Claim 18 (depends on 16) The method of claim 16, wherein the step of coupling the disk includes disposing the disk on an outside of at least one cell of the stent such that the disk cannot pass therethrough. ### Claim 19 (depends on 16) The method of claim 16, wherein delivering the occluder comprises disposing the occluder within a delivery system and advancing the delivery system to the heart valve. ### Claim 20 (depends on 19) The method of claim 19, further comprising: coupling the expandable disk to an inner wire of the delivery system. ### Claim 21 (depends on 20) The method of claim 20, further comprising: decoupling the expandable disk from the inner wire after coupling the expandable disk to the heart valve.