# US 11,304,797 B2 · Replacement heart valve methods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,304,797 B2 - Document ID: US11304797B2 - Status: Granted - Kind: B2 - Application number: 16/268,474 - Filed: 2019-02-05 - Published: 2019-06-06 - Granted: 2022-04-19 - Earliest claimed: 2013-08-14 - Assignees: Mitral Valve Technologies Sarl - Applicants: Mitral Valve Technologies Sari - Inventors: Paul A. Spence; Landon H. Tompkins; Mark Chau; Alexander J. Siegel - Web page: https://patentgrep.com/patent/US11304797B2 ## CPC - A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)} - A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves} - A61F 2/2418: {Scaffolds therefor, e.g. support stents} - A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation} - A61F 2/243: {Deployment by mechanical expansion} - A61F 2/2436: {Deployment by retracting a sheath} - A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol - A61F 2210/0076: multilayered, e.g. laminated structures - A61F 2230/0069: cylindrical - A61F 2230/0091: helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section - A61F 2250/006: modular - A61F 2250/0063: Nested prosthetic parts - 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 Methods for replacing a native heart valve. An anchor comprises coils adapted to support a heart valve prosthesis. The anchor is positioned at a native heart valve. An expansible heart valve prosthesis is delivered into the anchor and expanded inside the coils. This moves at least one coil from a first diameter to a second, larger diameter while securing the anchor and the heart valve prosthesis relative to each other. The heart valve prosthesis comprises a seal on the expansible heart valve prosthesis. Additional apparatus and methods are disclosed. ## Claims ### Claim 1 A method of implanting an expansible heart valve prosthesis in a heart of a patient, comprising: delivering an expansible helical anchor in the form of multiple coils proximate a native heart valve with the expansible helical anchor in a deployed but unexpanded state; positioning the expansible heart valve prosthesis within the multiple coils of the expansible helical anchor with the expansible heart valve prosthesis and the expansible helical anchor in unexpanded states; and expanding the expansible heart valve prosthesis against the expansible helical anchor thereby radially expanding the expansible heart valve prosthesis while securing the expansible heart valve prosthesis to the expansible helical anchor; wherein a seal is carried on the expansible heart valve prosthesis and extends between at least two adjacent coils of the multiple coils for preventing blood leakage through the expansible helical anchor and past the expansible heart valve prosthesis, wherein the seal includes a region that extends to an outflow end of a stent structure of the expansible heart valve prosthesis. ### Claim 2 (depends on 1) The method of claim 1, wherein the expanding the expansible heart valve prosthesis against the expansible helical anchor includes radially expanding the expansible heart valve prosthesis and at least a first coil of the multiple coils of the expansible helical anchor, wherein the first coil of the multiple coils has a first diameter in the deployed but unexpanded state that is expandable to a second, larger diameter as the expansible heart valve prosthesis is radially expanded against the expansible helical anchor, and wherein a second coil of the multiple coils moves from a larger diameter in the deployed but unexpanded state to a smaller diameter as the expansible heart valve prosthesis is expanded inside the multiple coils. ### Claim 3 (depends on 1) The method of claim 1, wherein the seal comprises at least two different materials, and wherein the seal includes the region that extends to the outflow end of the stent structure such that the seal wraps around end edges of each apex from an outer surface to an inner surface of the stent structure. ### Claim 4 (depends on 1) The method of claim 1, wherein the native heart valve is a native mitral valve, wherein the multiple coils of the expansible helical anchor comprise at least three coils, and wherein delivering the expansible helical anchor comprises positioning a plurality of coils of the at least three coils on a ventricular side of the native mitral valve around leaflets of the native mitral valve. ### Claim 5 (depends on 4) The method of claim 4, wherein expanding the expansible heart valve prosthesis comprises expanding the expansible heart valve prosthesis such that at least a portion of the leaflets of the native mitral valve are trapped between an outer wall of the expansible heart valve prosthesis and an inner surface of the expansible helical anchor. ### Claim 6 A method, comprising: delivering an anchor to a native heart valve such that at least two coils of the anchor encircle native tissue of the native heart valve, wherein the anchor comprises a layer of foam material over a wire portion; positioning an expansible prosthetic heart valve inside the anchor, the prosthetic heart valve comprising a stent structure, leaflets mounted to the stent structure, and a seal structure, wherein the seal structure comprises a seal layer circumscribing the stent structure and a bumper region covering an end edge of an outflow end of the stent structure, the seal structure arranged such that an entirety of the end edge of the outflow end of the stent structure is covered; and expanding the prosthetic heart valve inside the anchor such that the at least two coils expand to a larger diameter and the native tissue is trapped between the anchor and the prosthetic heart valve. ### Claim 7 (depends on 6) The method of claim 6, wherein a first coil portion of the at least two coils has a first radius in an unstressed state that is expandable to a second, larger radius as the prosthetic heart valve, and wherein a second coil portion of the at least two coils moves from a larger radius to a smaller radius as the prosthetic heart valve is expanded inside the at least two coils. ### Claim 8 (depends on 6) The method of claim 6, wherein the seal structure includes portions extending between adjacent coils for preventing blood leakage through the anchor and past the prosthetic heart valve. ### Claim 9 (depends on 6) The method of claim 6, wherein at least a portion of the stent structure extends into an interior of the bumper region. ### Claim 10 (depends on 6) The method of claim 6, wherein the seal structure comprises at least two different materials. ### Claim 11 (depends on 6) The method of claim 6, wherein the bumper region comprises a first material covering the end edge of the outflow end and a second material covering the first material, the second material different from the first material. ### Claim 12 (depends on 6) The method of claim 6, wherein the stent structure is an open stent structure and the seal structure is configured to cover openings in the open stent structure. ### Claim 13 A method, comprising: positioning an anchor at a native heart valve such that at least one coil of multiple coils of the anchor surrounds native tissue of the native heart valve; and expanding a prosthetic heart valve from a compressed configuration to an expanded configuration within the anchor such that a radial outward force inside the anchor causes at least one coil of the multiple coils to expand from a first diameter to a second, larger diameter, and the native tissue is trapped between the at least one coil and the prosthetic heart valve; wherein the prosthetic heart valve comprises a stent structure, a valve structure mounted to the stent structure, and a seal structure comprising a seal layer circumscribing the stent structure and a bumper at an outflow end of the stent structure, wherein the stent structure comprises a plurality of apices spaced apart from one another around the outflow end of the stent structure, and wherein the seal structure is arranged such that an end edge of every apex of the plurality of apices of the stent structure at the outflow end of the stent structure is covered by the bumper of the seal structure. ### Claim 14 (depends on 13) The method of claim 13, wherein the anchor includes a coil portion that transitions from a larger radius to a smaller radius as the prosthetic heart valve is expanded within the anchor. ### Claim 15 (depends on 13) The method of claim 13, wherein the anchor comprises at least three full coils. ### Claim 16 (depends on 13) The method of claim 13, wherein at least a portion of the stent structure extends into a center of the bumper, and wherein the bumper wraps around an entirety of the end edge of every apex at the outflow end of the stent structure, from an outer surface to an inner surface of the stent structure. ### Claim 17 (depends on 13) The method of claim 13, wherein the seal structure comprises at least two different materials. ### Claim 18 (depends on 13) The method of claim 13, wherein the stent structure is an open stent structure and the seal structure is configured to cover openings in the open stent structure. ### Claim 19 (depends on 13) The method of claim 13, wherein the anchor comprises a layer of foam material over a wire portion. ### Claim 20 (depends on 13) The method of claim 13, wherein the anchor comprises an upper anchor portion and a lower anchor portion that wind in opposite directions and are crimped together. ### Claim 21 A method, comprising; delivering an anchor to a native heart valve such that at least two coils of the anchor encircle native tissue of a native heart valve on an outflow side of the native heart valve; positioning an expansible prosthetic heart valve inside the anchor, the prosthetic heart valve comprising a stent structure having a plurality of apices at an outflow end thereof, leaflets attached to the stent structure, and a seal structure, wherein the seal structure comprises a region at the outflow end of the stent structure arranged such that an entire end edge of each apex of the plurality of apices at the outflow end of the stent structure is covered; and expanding the prosthetic heart valve inside the anchor such that the native tissue is trapped between an inner surface of the at least two coils of the anchor and an outer surface of the prosthetic heart valve.