# US 10,864,078 B2 · Prosthetic valve with separably-deployable valve body and tissue anchors > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,864,078 B2 - Document ID: US10864078B2 - Status: Granted - Kind: B2 - Application number: 16/660,231 - Filed: 2019-10-22 - Published: 2020-02-13 - Granted: 2020-12-15 - Earliest claimed: 2015-02-05 - Assignees: Cardiovalve Ltd. - Applicants: Cardiovalve Ltd. - Inventors: Ilia Hariton; Boaz Harari - Web page: https://patentgrep.com/patent/US10864078B2 ## CPC - A61F 2/2436: {Deployment by retracting a sheath} - 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 2/243: {Deployment by mechanical expansion} - A61F 2/9517: {handle assemblies therefor} - A61F 2002/91575: {connected peak to trough} - A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes - A61F 2220/0025: Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements - 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 Prosthetic valves and methods of use of prosthetic valves may be provided. In one implementation, a method of implanting a prosthetic valve within a native heart valve may be provided. The method may include delivering the prosthetic valve into a heart chamber while the prosthetic valve is constrained in a radially-contracted delivery configuration. The method may also include unconstraining ventricular tissue anchors and atrial tissue anchors of the prosthetic valve while maintaining an annular valve body of the prosthetic valve in the delivery configuration. The method may also include unconstraining the annular valve body from the delivery configuration while the unconstrained atrial tissue anchors and ventricular tissue anchors are positioned within an atrium and a ventricle, respectively. Unconstraining the annular valve body may decrease a longitudinal distance between the ventricular tissue anchors and atrial tissue anchors to secure the prosthetic valve within the native heart valve. ## Claims ### Claim 1 A method of implanting a prosthetic valve within a native heart valve, the method comprising: delivering the prosthetic valve into a heart chamber while the prosthetic valve is constrained in a radially-contracted delivery configuration, wherein the prosthetic valve comprises: an annular valve body, a plurality of ventricular tissue anchors configured to extend from the annular valve body, and a plurality of atrial tissue anchors configured to extend from the annular valve body; unconstraining the ventricular tissue anchors and the atrial tissue anchors from the radially-contracted delivery configuration within the heart while maintaining the annular valve body in the radially-contracted delivery configuration, such that a terminal end of at least one atrial tissue anchor moves radially outward relative to the annular valve body; and while the unconstrained ventricular tissue anchors are positioned downstream of the native heart valve and while the unconstrained atrial tissue anchors are positioned upstream of the native heart valve, unconstraining the annular valve body such that the annular valve body radially expands from the radially-contracted delivery configuration into a deployed configuration, wherein the radial expansion of the annular valve body decreases a longitudinal distance between the unconstrained ventricular tissue anchors and the unconstrained atrial tissue anchors to secure the prosthetic valve within the native heart valve. ### Claim 2 (depends on 1) The method of claim 1, wherein unconstraining the ventricular tissue anchors causes terminal ends of the ventricular tissue anchors to deflect radially outward relative to the annular valve body, and wherein unconstraining the atrial tissue anchors causes terminal ends of the atrial tissue anchors to deflect radially outward relative to the annular valve body. ### Claim 3 (depends on 1) The method of claim 1, further comprising: prior to unconstraining the atrial tissue anchors, moving the unconstrained ventricular tissue anchors so that the unconstrained ventricular tissue anchors engage tissue of the native heart valve. ### Claim 4 (depends on 1) The method of claim 1, wherein the prosthetic valve comprises: a first point of connection between the annular valve body and at least one ventricular tissue anchor; and a second point of connection between the annular valve body and the at least one atrial tissue anchor, wherein the radial expansion of the annular valve body decreases a longitudinal distance between the first point of connection and the second point of connection. ### Claim 5 (depends on 4) The method of claim 4, wherein the radial expansion of the annular valve body shifts the first point of connection and the second point of connection radially outward. ### Claim 6 (depends on 1) The method of claim 1, wherein the prosthetic valve is configured to be symmetrical about a longitudinal axis extending through the center of the annular valve body. ### Claim 7 (depends on 1) The method of claim 1, wherein the annular valve body comprises: an outer frame from which the ventricular tissue anchors extend; and an inner frame from which the atrial tissue anchors extend, the inner frame being situated at least partially within the outer frame, wherein the outer frame and the inner frame are constrained in the radially-contracted delivery configuration during the unconstraining of the ventricular tissue anchors and during the unconstraining of the atrial tissue anchors. ### Claim 8 (depends on 7) The method of claim 7, wherein a longitudinal distance between an upstream end and a downstream end of the outer frame is decreased when the annular valve body is unconstrained, and wherein a longitudinal distance between an upstream end and a downstream end of the inner frame is decreased when the annular valve body is unconstrained. ### Claim 9 (depends on 7) The method of claim 7, wherein the outer frame and inner frame are configured to be symmetrical about a longitudinal axis extending through the center of the annular valve body. ### Claim 10 (depends on 1) The method of claim 1, wherein the ventricular tissue anchors are configured to be offset from the atrial tissue anchors, with respect to a circumference of the annular valve body. ### Claim 11 (depends on 1) The method of claim 1, wherein the ventricular tissue anchors extend from the annular valve body at ventricular anchor connection points and the atrial tissue anchors extend from the annular valve body at atrial anchor connection points, the ventricular anchor connection points being spaced apart from the atrial anchor connection points with respect to a longitudinal axis extending through the center of the annular valve body. ### Claim 12 (depends on 1) The method of claim 1, wherein unconstraining the ventricular tissue anchors and atrial tissue anchors includes releasing terminal ends of the ventricular tissue anchors and terminal ends of the atrial tissue anchors from a prosthetic valve delivery device. ### Claim 13 A method of implanting a prosthetic valve within a native heart valve, the method comprising: delivering the prosthetic valve into a heart chamber while the prosthetic valve is constrained in a radially-contracted delivery configuration, wherein the prosthetic valve comprises: an annular valve body, a plurality of ventricular tissue anchors configured to extend from the annular valve body, wherein at least one ventricular tissue anchor has a single point of connection to the annular valve body, and a plurality of atrial tissue anchors configured to extend from the annular valve body, wherein at least one atrial tissue anchor has a single point of connection to the annular valve body; unconstraining the ventricular tissue anchors and the atrial tissue anchors within the heart while maintaining the annular valve body in the radially-contracted delivery configuration, wherein unconstraining the ventricular tissue anchors causes terminal ends of the ventricular tissue anchors to deflect radially outward relative to the annular valve body; and while the unconstrained ventricular tissue anchors are positioned downstream of the native heart valve and while the unconstrained atrial tissue anchors are positioned upstream of the native heart valve, unconstraining the annular valve body from the radially-contracted delivery configuration. ### Claim 14 (depends on 13) The method of claim 13, wherein each ventricular tissue anchor has a single point of connection to the annular valve body that is distinct from the points of connection between the other ventricular tissue anchors and the annular valve body, and wherein each atrial tissue anchor has a single point of connection to the annular valve body that is distinct from the points of connection between the other atrial tissue anchors and the annular valve body. ### Claim 15 (depends on 14) The method of claim 14, wherein beyond the points of connection between the ventricular tissue anchors and the annular valve body, the ventricular tissue anchors are devoid of interconnections, and wherein beyond the points of connection between the atrial tissue anchors and the annular valve body, the atrial tissue anchors are devoid of interconnections. ### Claim 16 (depends on 13) The method of claim 13, wherein unconstraining the atrial tissue anchors causes terminal ends of the atrial tissue anchors to deflect radially outward relative to the annular valve body. ### Claim 17 (depends on 13) The method of claim 13, wherein unconstraining the annular valve body causes the annular valve body to radially expand from the radially-contracted delivery configuration into a deployed configuration, and wherein the radial expansion of the annular valve body secures the prosthetic valve to the native heart valve. ### Claim 18 (depends on 13) The method of claim 13, wherein the prosthetic valve is configured to be symmetrical about a longitudinal axis extending through the center of the annular valve body. ### Claim 19 (depends on 13) The method of claim 13, wherein the annular valve body comprises: an outer frame from which the ventricular tissue anchors extend; and an inner frame from which the atrial tissue anchors extend, the inner frame being situated at least partially within the outer frame, wherein the outer frame and the inner frame are constrained in the radially-contracted delivery configuration during unconstraining of the ventricular tissue anchors and during unconstraining of the atrial tissue anchors. ### Claim 20 (depends on 19) The method of claim 19, wherein the outer frame and inner frame are configured to be symmetrical about a longitudinal axis extending through the center of the annular valve body. ### Claim 21 (depends on 19) The method of claim 19, wherein the annular valve body further comprises: at least one connector configured to secure the outer frame and the inner frame against relative longitudinal movement, the connector comprising at least one of a mechanical connector extending between the outer frame and the inner frame, solder, or a weld. ### Claim 22 (depends on 13) The method of claim 13, wherein the unconstrained atrial tissue anchors are configured to be offset from the unconstrained ventricular tissue anchors, with respect to a circumference of the annular valve body. ### Claim 23 A method of implanting a prosthetic valve within a native heart valve, the method comprising: delivering the prosthetic valve into a heart chamber while the prosthetic valve is constrained in a radially-contracted delivery configuration, wherein the prosthetic valve comprises: an annular valve body, a plurality of ventricular tissue anchors configured to extend from the annular valve body, and a plurality of atrial tissue anchors configured to extend from the annular valve body; unconstraining the ventricular tissue anchors and the atrial tissue anchors from the radially-contracted delivery configuration within the heart while maintaining the annular valve body in the radially-contracted delivery configuration, wherein unconstraining the ventricular tissue anchors causes terminal ends of the ventricular tissue anchors to deflect radially outward relative to the annular valve body; and while the unconstrained ventricular tissue anchors are positioned downstream of the native heart valve and while the unconstrained atrial tissue anchors are positioned upstream of the native heart valve, unconstraining the annular valve body from the radially-contracted delivery configuration. ### Claim 24 (depends on 23) The method of claim 23, wherein unconstraining the atrial tissue anchors causes terminal ends of the atrial tissue anchors to deflect radially outward relative to the annular valve body.