# US 11,026,791 B2 · Flexible canopy valve repair systems and methods of use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,026,791 B2 - Document ID: US11026791B2 - Status: Granted - Kind: B2 - Application number: 16/352,963 - Filed: 2019-03-14 - Published: 2019-09-26 - Granted: 2021-06-08 - Earliest claimed: 2018-03-20 - Assignees: Medtronic Vascular, Inc. - Applicants: Medtronic Vascular, Inc. - Inventors: Matthew Genovese; Jeffrey Sandstrom; Russell Pribanic; Thomas Mcpeak; Vania Lee; Dermot O'Brien; James Calvin Allan - Web page: https://patentgrep.com/patent/US11026791B2 ## CPC - A61F 2/2454: {Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses} - A61F 2/2457: {Chordae tendineae prostheses} - A61F 2/2463: {Implants forming part of the valve leaflets} - A61F 2/2466: {Delivery devices therefor} - 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 2017/00243: {cardiac} - A61B 2017/044: {with a threaded shaft, e.g. screws} - A61B 2017/0464: {for soft tissue} - A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves} - A61F 2230/0095: Saddle-shaped - A61F 2250/0018: differing in elasticity, stiffness or compressibility - 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 treating valvular regurgitation in a heart valve includes a flexible canopy and an elongated tether including an elastic portion and an inelastic portion. When the system is in a deployed configuration, a proximal end of the flexible canopy is coupled to an annulus of the heart valve and a distal end of the elongated tether is coupled to a ventricle. The flexible canopy is configured to overlay a first native leaflet of the heart valve, and tension on the elongated tether is applied and/or adjusted to prevent the first leaflet from prolapsing, to maximize coaptation of the flexible canopy with a second native leaflet of the heart valve, and to minimize regurgitation of the heart valve. ## Claims ### Claim 1 A system for treating valvular regurgitation in a heart valve, the system including a delivery configuration and a deployed configuration, the system comprising: a flexible canopy including a first surface and a second surface opposite the first surface; an elongated tether configured to be placed under tension in situ, the elongated tether including an elastic portion and an inelastic portion coupled to the elastic portion, wherein the elastic portion is at least as long as the inelastic portion with a ratio of the elastic portion to the inelastic portion being between 50/50 and 70/30 and a proximal end of the elongated tether is attached to a distal end of the flexible canopy; and a distal anchor configured to be embedded into tissue of a ventricle, wherein a distal end of the elongated tether is coupled to the distal anchor, wherein when the system is in the deployed configuration, a proximal end of the flexible canopy is anchored to an annulus of the heart valve and the distal end of the elongated tether is anchored to tissue of a ventricle via the distal anchor such that the first surface of the flexible canopy overlays an underlying first surface of a first leaflet of the heart valve, and the elongated tether is placed under tension such that the system is configured to prevent the first leaflet of the heart valve from prolapsing, and to permit a portion of the second surface of the flexible canopy to coapt with at least an opposing mating portion of a second leaflet of the heart valve. ### Claim 2 (depends on 1) The system of claim 1, wherein when the first surface of the flexible canopy overlays the first leaflet of the heart valve, the first surface of the flexible canopy is substantially in contact with between forty and ninety percent of the underlying first surface of the first leaflet of the heart valve. ### Claim 3 (depends on 1) The system of claim 1, wherein the flexible canopy does not extend into the ventricle when the system is in the deployed configuration. ### Claim 4 (depends on 1) The system of claim 1, wherein the inelastic portion of the elongated tether is positioned distal of the elastic portion of the elongated tether. ### Claim 5 (depends on 1) The system of claim 1, wherein the elastic portion of the elongated tether is positioned distal of the inelastic portion of the elongated tether. ### Claim 6 (depends on 1) The system of claim 1, wherein the elastic portion of the elongated tether is longer than the inelastic portion of the elongated tether. ### Claim 7 (depends on 1) The system of claim 1, wherein the elastic portion of the elongated tether is a spring. ### Claim 8 (depends on 1) The system of claim 1, further comprising: a frame coupled to a portion of the flexible canopy. ### Claim 9 (depends on 8) The system of claim 8, wherein the frame does not extend into the ventricle when the system is in the deployed configuration. ### Claim 10 (depends on 1) The system of claim 1, wherein the flexible canopy is unsupported and does not include a frame coupled thereto. ### Claim 11 (depends on 1) The system of claim 1, wherein the flexible canopy extends into the ventricle when the system is in the deployed configuration. ### Claim 12 A system for treating valvular regurgitation in a heart valve, the system including a delivery configuration and a deployed configuration, the system comprising: a flexible canopy including a first surface and a second surface opposite the first surface; and an elongated tether configured to be placed under tension in situ, the elongated tether including an elastic portion and an inelastic portion coupled to the elastic portion, wherein the elastic portion is at least as long as the inelastic portion and a proximal end of the elongated tether is attached to a distal end of the flexible canopy, wherein when the system is in the deployed configuration, a proximal end of the flexible canopy is anchored to an annulus of the heart valve and a distal end of the elongated tether is anchored to tissue of a ventricle such that the first surface of the flexible canopy overlays an underlying first surface of a first leaflet of the heart valve, and the elongated tether is placed under tension such that the system is configured to prevent the first leaflet of the heart valve from prolapsing, and to permit a portion of the second surface of the flexible canopy to coapt with at least an opposing mating portion of a second leaflet of the heart valve, and wherein the first surface of the flexible canopy includes at least one micro-barb and the at least one micro-barb is configured to couple the first surface of the flexible canopy to the underlying first surface of the first leaflet of the heart valve. ### Claim 13 A system for treating valvular regurgitation in a heart valve, the system including a delivery configuration and a deployed configuration, the system comprising: a flexible canopy including a first surface and a second surface opposite the first surface, wherein the flexible canopy is unsupported and does not include a frame coupled thereto; and an elongated tether configured to be placed under tension in situ, the elongated tether including an elastic portion and an inelastic portion coupled to the elastic portion, wherein a ratio of the elastic portion to the inelastic portion is between 50/50 and 70/30, and wherein a proximal end of the elongated tether is attached to a distal end of the flexible canopy; and a distal anchor configured to be embedded into tissue of a ventricle, wherein a distal end of the elongated tether is coupled to the distal anchor, wherein when the system is in the deployed configuration, a proximal end of the flexible canopy is anchored to an annulus of the heart valve and the distal end of the elongated tether is anchored to tissue of a ventricle via the distal anchor such that the first surface of the flexible canopy overlays an underlying first surface of a first leaflet of the heart valve, and the elongated tether is placed under tension such that the system is configured to prevent the first leaflet of the heart valve from prolapsing, and to permit a portion of the second surface of the flexible canopy to coapt with at least an opposing mating portion of a second leaflet of the heart valve. ### Claim 14 (depends on 13) The system of claim 13, wherein when the first surface of the flexible canopy overlays the first leaflet of the heart valve, the first surface of the flexible canopy is substantially in contact with between forty and ninety percent of the underlying first surface of the first leaflet of the heart valve. ### Claim 15 (depends on 13) The system of claim 13, wherein the first surface of the flexible canopy includes at least one micro-tine and the at least one micro-tine is configured to couple the first surface of the flexible canopy to the underlying first surface of the first leaflet of the heart valve. ### Claim 16 (depends on 13) The system of claim 13, wherein the flexible canopy does not extend into the ventricle when the system is in the deployed configuration. ### Claim 17 (depends on 13) The system of claim 13, wherein the flexible canopy extends into the ventricle when the system is in the deployed configuration. ### Claim 18 (depends on 13) The system of claim 13, wherein the inelastic portion of the elongated tether is positioned distal of the elastic portion of the elongated tether. ### Claim 19 (depends on 13) The system of claim 13, wherein the elastic portion of the elongated tether is positioned distal of the inelastic portion of the elongated tether. ### Claim 20 (depends on 13) The system of claim 13, wherein the elastic portion of the elongated tether is longer than the inelastic portion of the elongated tether.