# US 10,869,756 B2 · Devices, systems, and methods to optimize annular orientation of transcatheter valves > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,869,756 B2 - Document ID: US10869756B2 - Status: Granted - Kind: B2 - Application number: 15/554,691 - Filed: 2016-03-10 - Published: 2018-03-22 - Granted: 2020-12-22 - Earliest claimed: 2015-03-12 - Assignees: Cedars-Sinai Medical Center - Applicants: Cedars-Sinai Medical Center - Inventors: Hasanian Al-Jilaihawi - Web page: https://patentgrep.com/patent/US10869756B2 ## CPC - A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)} - A61F 2/2433: {using balloon catheter} - A61F 2/2436: {Deployment by retracting a sheath} - A61F 2/2418: {Scaffolds therefor, e.g. support stents} - A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol - A61F 2230/0065: toroidal, e.g. ring-shaped, doughnut-shaped - A61F 2250/0003: having an inflatable pocket filled with fluid, e.g. liquid or gas - A61F 2250/006: modular - A61F 2250/007: O-rings - 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 In various embodiments, provided herein are methods, devices and systems to optimize annular orientation of transcatheter valves and thereby facilitate transcatheter aortic valve replacement in the setting of challenging cardiovascular anatomy. These methods, devices and systems are used to treat patients with valvular diseases. To solve these problems, described herein is a Device to Optimize aNnUlar orientation of Transcathether valves (DONUT). DONUT can correct large differences between a native valve's anatomical dimensions and the external dimensions of a transcatheter valve stent frame. ## Claims ### Claim 1 A device for transcatheter valve replacement, comprising: a ring-shaped article comprising a stent frame, wherein the stent frame comprises an inflatable hollow plastic external layer, wherein the ring-shaped article comprises an outside surface, wherein the outside surface comprises an inward surface area that faces toward the center of the ring-shaped article and forms a center hole, wherein the outside surface comprises an outward surface area that faces away from the center hole of the ring-shaped article and forms a periphery, wherein the ring-shaped article has a compressed status and an expanded status; wherein when the ring-shaped article is expanded, the center hole is configured to fit and receive a replacement heart valve, and the periphery is configured to act as a mould to a native anatomy of a heart valve peri-annular region, cardiovascular structure or chamber. ### Claim 2 (depends on 1) The device of claim 1, wherein the heart valve is a mitral, aortic, tricuspid or pulmonary valve. ### Claim 3 (depends on 1) The device of claim 1, wherein the periphery is configured to anchor to the heart valve peri-annular region or the periphery is configured to anchor to the ventricular, atrial, aortic, or arterial wall. ### Claim 4 (depends on 1) The device of claim 1, wherein the replacement heart valve is configured to anchor to the center hole of the ring-shaped article. ### Claim 5 (depends on 1) The device of claim 1, wherein the ring-shaped article and the replacement heart valve are not connected to each other. ### Claim 6 (depends on 1) The device of claim 1, wherein, the replacement heart valve is about 10-55 mm in height; the ring-shaped article is about 5-55 mm in height; the replacement heart valve is about 10-55 mm in diameter; the center hole of the ring-shaped article is about 10-55 mm in diameter; and the periphery of the ring-shaped article is about 15-80 mm in diameter. ### Claim 7 (depends on 1) The device of claim 1, wherein the center hole of the ring-shaped article is shaped as circular, elliptical, oval, or a D ring and the periphery of the ring-shaped article is shaped to conform to the region in which the device is deployed. ### Claim 8 (depends on 1) The device of claim 1, wherein the cross section of the replacement valve is a circle, ellipse, oval, or D-shape. ### Claim 9 (depends on 1) The device of claim 1, wherein the ring-shaped article is self-expandable or balloon expandable. ### Claim 10 (depends on 1) The device of claim 1, wherein the ring-shaped article comprises a frame made of iron, platinum, titanium, nickel, chromium, cobalt, magnesium, stainless steel, nitinol (nickel-titanium), nickel-chromium, cobalt-chromium, or platinum-iridium, or a combination thereof, or of a solid or hollow plastic material. ### Claim 11 (depends on 1) The device of claim 1, wherein the replacement heart valve is self-expandable or balloon expandable. ### Claim 12 (depends on 1) The device of claim 1, wherein the replacement valve comprises a stent frame made of iron, platinum, titanium, nickel, chromium, cobalt, magnesium, stainless steel, nitinol (nickel-titanium), nickel-chromium, cobalt-chromium, or platinum-iridium, or a combination thereof, or of a solid or hollow plastic material. ### Claim 13 (depends on 1) The device of claim 1, wherein the replacement heart valve is a prosthetic valve or a bioprosthetic valve. ### Claim 14 (depends on 1) The device of claim 1, wherein the replacement valve comprises one, two, three, or more leaflets. ### Claim 15 (depends on 1) The device of claim 1, further comprising the replacement heart valve. ### Claim 16 (depends on 1) The device of claim 1, further comprising a first delivery catheter, wherein the first delivery catheter is configured to deploy the ring-shaped article into the heart valve peri-annular region. ### Claim 17 (depends on 16) The device of claim 16, wherein the first delivery catheter comprises an inflatable balloon near or at its distal end, wherein the ring-shaped article is configured to be mounted on the inflatable balloon when compressed, and wherein the inflatable balloon is configured to be inflated so as to expand the ring-shaped article when compressed. ### Claim 18 (depends on 17) The device of claim 17, further comprising a second delivery catheter, wherein the second delivery catheter is configured to deploy the replacement heart valve into the center hole of the ring-shaped article. ### Claim 19 (depends on 18) The device of claim 18, further comprising a guide wire, wherein the second delivery catheter is configured to be inserted over the guide wire. ### Claim 20 (depends on 16) The device of claim 16, wherein the first delivery catheter comprises an enclosing sheath near or at its distal end, wherein the ring-shaped article is configured to be enclosed in the enclosing sheath when compressed, and wherein the enclosing sheath is configured to be retracted so as to expand the ring-shaped article. ### Claim 21 (depends on 16) The device of claim 16, further comprising a guide wire, wherein the first delivery catheter is configured to be inserted over the guide wire.