# US 12,594,158 B2 · Anti-paravalvular leakage component for a transcatheter valve prosthesis > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,594,158 B2 - Document ID: US12594158B2 - Status: Granted - Kind: B2 - Application number: 17/210,636 - Filed: 2021-03-24 - Published: 2021-07-08 - Granted: 2026-04-07 - Earliest claimed: 2013-02-01 - Assignees: Medtronic Cv Luxembourg S.A.R.L. - Applicants: Medtronic CV Luxembourg S.a.r.l. - Inventors: Carol Eberhardt; Gopikrishnan Soundararajan; Kenny Dang; Hussain Rangwala; Mark Torrianni; Eric Richardson; Kshitija Garde - Web page: https://patentgrep.com/patent/US12594158B2 ## CPC - 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 2220/005: using adhesives - A61F 2230/0013: Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped - A61F 2230/008: paraboloidal - A61F 2250/0069: Sealing means - 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 transcatheter valve prosthesis includes an expandable tubular stent, a prosthetic valve within the stent, and an anti-paravalvular leakage component coupled to and encircling the tubular stent. The anti-paravalvular leakage component includes a radially-compressible annular scaffold, which is a sinusoidal patterned ring of self-expanding material, and an impermeable membrane extending over the annular scaffold. The anti-paravalvular leakage component has an expanded configuration in which at least segments of the annular scaffold curve radially away from the tubular stent. Alternatively, the anti-paravalvular leakage component includes a plurality of self-expanding segments and an annular sealing element coupled to inner surfaces of the segments. The anti-paravalvular leakage component has an expanded configuration in which the segments curve radially away from the tubular stent and the annular sealing element is positioned between an outer surface of the tubular stent and inner surfaces of the segments. ## Claims ### Claim 1 A transcatheter valve prosthesis comprising: a stent having a radially compressed configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve, the stent including a support frame of struts and openings defined between the struts; a prosthetic valve component disposed within and secured to the stent; and a continuous outer annular component circumferentially surrounding an outer surface of the stent, the outer annular component including a plurality of self-expanding segments and an annular sealing element, the self-expanding segments coupled to and extending from the stent, the annular sealing element coupled to and covering an outer surface or an inner surface of each of the self-expanding segments, the outer annular component having an expanded configuration in which the self-expanding segments curve and extend radially away from the outer surface of the stent, wherein each self-expanding segment extends in a longitudinal direction of the stent and has a first end and a second end which are longitudinally spaced apart relative to the outer surface of the stent when the outer annular component is in the expanded configuration. ### Claim 2 (depends on 1) The transcatheter valve prosthesis of claim 1, wherein the self-expanding segments bow and the first and second ends of each self-expanding segment curves radially inward toward to outer surface of the stent. ### Claim 3 (depends on 2) The transcatheter valve prosthesis of claim 2, wherein the outer annular component includes a sinusoidal patterned ring of self-expanding material that defines a plurality of peaks and a plurality of valleys, and wherein each self-expanding segment is formed to extend between a respective peak and valley of the pluralities of peaks and valleys. ### Claim 4 (depends on 3) The transcatheter valve prosthesis of claim 3, wherein the plurality of peaks is attached to the outer surface of the stent and the plurality of valleys is not attached to the outer surface of the stent. ### Claim 5 (depends on 4) The transcatheter valve prosthesis of claim 4, wherein the outer annular component has a delivery configuration and wherein the plurality of valleys are configured to slide along the outer surface of the stent when transitioning between the delivery and expanded configurations of the outer annular component. ### Claim 6 (depends on 1) The transcatheter valve prosthesis of claim 1, wherein the first end of each self-expanding segment is attached to the outer surface of the stent. ### Claim 7 (depends on 6) The transcatheter valve prosthesis of claim 6, wherein the second end of each self-expanding segment is attached to the outer surface of the stent. ### Claim 8 (depends on 7) The transcatheter valve prosthesis of claim 7, wherein the stent includes a plurality of diamond-shaped openings and each self-expanding segment extends over a diamond-shaped opening of the plurality of diamond-shaped openings. ### Claim 9 (depends on 1) The transcatheter valve prosthesis of claim 1, wherein the annular sealing element includes a knit or woven polyester. ### Claim 10 (depends on 1) The transcatheter valve prosthesis of claim 1, wherein the annular sealing element is formed from a swellable material that collapses easily and expands to a larger volume after implantation. ### Claim 11 (depends on 1) The transcatheter valve prosthesis of claim 1, wherein the annular sealing element is formed from a compressible foam. ### Claim 12 (depends on 1) The transcatheter valve prosthesis of claim 1, wherein each self-expanding segment has a different cross-section and/or size from the struts of the stent. ### Claim 13 (depends on 12) The transcatheter valve prosthesis of claim 12, wherein each self-expanding segment is thinner than the struts of the stent. ### Claim 14 (depends on 12) The transcatheter valve prosthesis of claim 12, wherein each self-expanding segment has a circular cross-section and the struts of the stent have a non-circular cross-section. ### Claim 15 (depends on 1) The transcatheter valve prosthesis of claim 1, wherein each self-expanding segment has a concave profile when the outer annular component is in the expanded configuration. ### Claim 16 (depends on 1) The transcatheter valve prosthesis of claim 1, wherein each self-expanding segment has a convex profile when the outer annular component is in the expanded configuration. ### Claim 17 (depends on 1) The transcatheter valve prosthesis of claim 1, wherein the annular sealing element is attached to inner surfaces of the plurality of self-expanding segments and is disposed between the outer surface of the stent and the inner surfaces of the plurality of self-expanding segments when the outer annular component is in the expanded configuration.