# US 11,026,782 B2 · Heart chamber prosthetic valve implant with elevated valve section and single chamber anchoring for preservation, supplementation and/or replacement of native valve function > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,026,782 B2 - Document ID: US11026782B2 - Status: Granted - Kind: B2 - Application number: 15/674,041 - Filed: 2017-08-10 - Published: 2018-02-15 - Granted: 2021-06-08 - Earliest claimed: 2016-08-11 - Assignees: 4C Medical Technologies, Inc. - Applicants: 4C Medical Technologies, Inc. - Inventors: Jeffrey W. Chambers - Web page: https://patentgrep.com/patent/US11026782B2 ## CPC - A61F 2/2418: {Scaffolds therefor, e.g. support stents} - A61F 2/24: Heart valves {; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body} - 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 2/2442: {Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve} - A61F 2/2487: {Devices within the heart chamber, e.g. splints} - A61F 2/2445: {Annuloplasty rings in direct contact with the valve annulus} - A61F 2/2454: {Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses} - A61F 2/2463: {Implants forming part of the valve leaflets} - A61F 2/2469: {with resilient valve members, e.g. conical spiral} - A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol - A61F 2230/0069: cylindrical - A61F 2250/0048: differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability - 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 Various embodiments of the present invention comprise a single-chamber collapsible and expandable prosthetic valve implant device with an elevated valve section and comprising the following capabilities: (1) preservation of native valve functionality; (2) initial preservation of native valve functionality with subsequent full replacement of native valve functionality; (3) full replacement of native valve functionality; and/or (4) mitigation of the prolapsing distance of the dysfunctional leaflets by preventing the anterior excursion of the prolapsing leaflets above the upper annular surface and into the left atrial chamber in order to preserve native leaflet functionality for as long as possible. The expanded and implanted device does not extend beyond the boundaries of the subject heart chamber, e.g., the left atrium, thereby enabling the preservation of any remaining native valve functionality with subsequent full replacement of native valve functionality if and when needed. ## Claims ### Claim 1 A device for expanded implantation within a heart chamber that is in fluid communication with an annulus comprising an annular plane and with a native valve having leaflets, the expanded and implanted device comprising: a base section comprising a lower surface that is configured to be at least partially disposed on the annular plane, the lower surface comprising a raised portion configured to be spaced above the lower surface of the base section and the annular plane; an atrial dome section configured to be in pressured and frictional engagement with a roof of the heart chamber when the device is expanded and implanted; an intermediate section comprising an expandable mesh and operatively attached to the base section and the atrial dome section; and a central cylinder valve support comprising a lower surface, the central cylinder valve support operatively attached to the raised portion of the base section and comprising at least one prosthetic valve leaflet operatively attached therein, the lower surface of the central cylinder valve support spaced above the lower surface of the base section. ### Claim 2 (depends on 1) The device of claim 1, further comprising the at least one prosthetic valve leaflet attached within the central cylinder valve support at the lower surface of the central cylinder valve support. ### Claim 3 (depends on 1) The device of claim 1, further comprising the at least one prosthetic valve leaflet attached within the central cylinder valve support at a point that is located above the lower surface of the central cylinder valve support. ### Claim 4 (depends on 1) The device of claim 1, wherein the heart chamber comprises the left atrium and the native valve comprises the mitral valve comprising native leaflets. ### Claim 5 (depends on 1) The device of claim 1, further comprising the expanded and implanted device configured to have no structural engagement with the native valve leaflets. ### Claim 6 (depends on 4) The device of claim 4, further comprising the expanded and implanted device configured to have no structural engagement with the native mitral valve comprising native leaflets. ### Claim 7 (depends on 4) The device of claim 4, further comprising the expanded and implanted device configured to have no structural presence within the left ventricle. ### Claim 8 (depends on 4) The device of claim 4, further comprising the expanded and implanted device configured to have no structural presence within a pulmonary artery. ### Claim 9 A device for expanded implantation within a heart chamber that is in fluid communication with an annulus comprising an annular plane and with a native valve having leaflets, the expanded and implanted device comprising: a base section comprising a lower surface that is configured to be at least partially disposed on the annular plane, the lower surface defining an aperture adapted to be located around the annulus; a top section configured to be in pressured and frictional engagement with a roof of the heart chamber when the device is expanded and implanted; an intermediate section comprising an expandable mesh and operatively attached to the base section and the top section; and a central cylinder valve support comprising a lower surface, the lower surface of the central cylinder valve support operatively connected with a portion of the lower surface that defines the aperture, the central cylinder valve support further comprising at least one prosthetic valve leaflet operatively attached therein, wherein the lower surface of the central cylinder valve support is configured to not extend below the annular plane. ### Claim 10 (depends on 9) The device of claim 9, further comprising the at least one prosthetic valve leaflet attached within the central cylinder valve support at the lower surface of the central cylinder valve support. ### Claim 11 (depends on 9) The device of claim 9, further comprising the at least one prosthetic valve leaflet attached within the central cylinder valve support at a point that is located above the lower surface of the central cylinder valve support. ### Claim 12 (depends on 9) The device of claim 9, wherein the heart chamber comprises the left atrium and the native valve comprises the mitral valve. ### Claim 13 (depends on 12) The device of claim 12, further comprising the expanded and implanted device comprising no structural presence within the left ventricle. ### Claim 14 (depends on 12) The device of claim 12, further comprising the expanded and implanted device comprising no structural engagement with the native valve leaflets. ### Claim 15 (depends on 12) The device of claim 12, further comprising the expanded and implanted device comprising no structural presence within a pulmonary artery. ### Claim 16 (depends on 1) A method for preserving the functionality of a patient's at least partially malfunctioning native heart valve with an implanted prosthetic heart valve device within a heart chamber comprising an annulus defining an annular plane, comprising: providing the device of claim 1 and expanding and implanting the device within a single heart chamber, wherein the heart chamber is at least partially protected from retrograde flow by the malfunctioning native valve, wherein at least a portion of the lower surface of the base section is disposed on the annular plane, and wherein the central cylinder valve support, and the at least one prosthetic valve leaflet attached therein, do not extend below the annular plane; and preserving the remaining normal native functionality of the at least partially malfunctioning native valve with the expanded and implanted device. ### Claim 17 (depends on 16) The method of claim 16, wherein the single chamber of the heart comprises the left atrium and the native valve is the mitral valve comprising native leaflets. ### Claim 18 (depends on 17) The method of claim 17, comprising ensuring the expanded and implanted device has no structural presence in, or engagement with, the mitral valve comprising native leaflets or with the patient's left ventricle. ### Claim 19 (depends on 17) The method of claim 17, further comprising ensuring the expanded and implanted device has no structural presence in, or engagement with, a pulmonary artery. ### Claim 20 (depends on 1) A method for preserving and supplementing the functionality of a patient's at least partially malfunctioning native heart valve with an implanted prosthetic heart valve device within a heart chamber comprising an annulus defining an annular plane, comprising: providing the device of claim 1 and expanding and implanting the device within a single heart chamber, wherein the heart chamber is at least partially protected from retrograde flow by the malfunctioning native valve, wherein at least a portion of the lower surface of the base section is disposed on the annular plane, and wherein the central cylinder valve support does not extend below the annular plane; and preserving and supplementing the remaining normal native functionality of the at least partially malfunctioning native valve with the expanded and implanted prosthetic heart valve device. ### Claim 21 (depends on 20) The method of claim 20, wherein the single chamber of the heart comprises the left atrium and the native valve is the mitral valve. ### Claim 22 (depends on 21) The method of claim 21, further comprising ensuring the expanded and implanted device has no structural presence in, or engagement with, the mitral valve comprising native leaflets or with the patient's left ventricle. ### Claim 23 (depends on 22) The method of claim 22, further comprising ensuring the expanded and implanted device has no structural presence in, or engagement with, a pulmonary artery. ### Claim 24 (depends on 1) A method for preserving and supplementing any remaining native functionality of a patient's at least partially malfunctioning native heart valve and replacing the heart valve functionality with an implanted prosthetic heart valve device with an implanted prosthetic heart valve device within a heart chamber comprising an annulus defining an annular plane, comprising: providing the device of claim 1 and expanding and implanting the device within a single heart chamber, wherein the heart chamber is at least partially protected from retrograde flow by the malfunctioning native valve, wherein at least a portion of the lower surface of the base section is disposed on the annular plane and wherein the central cylinder valve support, and the at least one prosthetic valve leaflet attached therein, do not extend below the annular plane; preserving and supplementing the remaining normal native functionality of the malfunctioning native valve with the expanded and implanted device; and completely replacing the native valve functionality when the native valve ceases to provide any normal native functionality. ### Claim 25 (depends on 24) The method of claim 24, wherein the single chamber of the heart is the left atrium and the native valve is the mitral valve comprising native leaflets. ### Claim 26 (depends on 25) The method of claim 25, further comprising ensuring the expanded and implanted device has no structural engagement with the native mitral valve comprising leaflets or the patient's left ventricle. ### Claim 27 (depends on 25) The method of claim 25, further comprising ensuring the expanded and implanted device has no structural presence in, or engagement with, a pulmonary artery.