# US 10,765,511 B2 · Transcatheter heart valve with plication tissue anchors > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,765,511 B2 - Document ID: US10765511B2 - Status: Granted - Kind: B2 - Application number: 16/016,512 - Filed: 2018-06-22 - Published: 2019-12-26 - Granted: 2020-09-08 - Earliest claimed: 2018-06-22 - Assignees: VDyne, Inc. - Applicants: Vdyne, LLC - Inventors: Robert Vidlund; Mark Christianson; David Holtan - Web page: https://patentgrep.com/patent/US10765511B2 ## CPC - 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 2/2427: {Devices for manipulating or deploying heart valves during implantation} - A61F 2220/0008: Fixation appliances for connecting prostheses to the body - A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes - A61F 2230/0052: T-shaped - A61F 2230/0054: V-shaped - A61F 2230/0091: helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section - A61F 2250/0004: adjustable - A61F 2250/0039: differing in diameter - A61F 2250/0069: Sealing means - 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 The invention relates to a transcatheter heart valve replacement (A61F2/2412), and in particular a device and method for percutaneous annular plication and heart valve deployment for mounting a pressure actuated flow control sleeve, a pinch valve, as a replacement device for a heart valve, whereby the prosthesis has an atrial annular flange or cuff having one or more integral plication tissue anchors for engaging the valve annulus, wherein the is a reciprocating mechanical member that is compressed by pressurized working fluid within the heart during ventricular systole. ## Claims ### Claim 1 A transcatheter heart valve replacement comprising: an asymmetric wire frame with an upper angled collar of scalloped diamond-shape cells forming an atrial flange; a middle ring defining a lumen connected to the atrial flange, the middle ring comprised of a plurality of diamond-shape cells; a reciprocating flow control member mounted on the middle ring and disposed within the lumen; and a plurality of tissue anchors, each tissue anchor mounted on the wire frame for engaging annular tissue; wherein the atrial flange has a steep angle of inclination at a septal region of the wire frame, and a shallower angle of inclination around anterior and posterior annular regions of the wire frame; wherein the wire frame has an inner covering of pericardial tissue, and an outer covering of a polyester material. ### Claim 2 (depends on 1) The transcatheter heart valve replacement of claim 1, wherein there is a second lower angled collar of scalloped diamond shapes forming a sub-annular ventricular flange. ### Claim 3 (depends on 1) The transcatheter heart valve replacement of claim 1, wherein the steep angle is between 30-90 degrees to the horizontal plane of the annulus. ### Claim 4 (depends on 1) The transcatheter heart valve replacement of claim 1, wherein the tissue anchor comprises a floating radio-opaque marker threaded onto the tissue anchor, wherein advancing the tissue anchor through tissue moves the floating radio-opaque marker from an initial distal lower thread position on the anchor to a secondary position on a higher thread. ### Claim 5 (depends on 4) The transcatheter heart valve replacement of claim 4, wherein one or more of the tissue anchors or the secondary tissue anchors are selected from the group consisting of: a straight thread constant pitch fastener, a tapered thread constant pitch fastener, a straight thread variable pitch fastener, a tapered thread variable pitch fastener, and a sunken taper thread variable pitch fastener. ### Claim 6 (depends on 4) The transcatheter heart valve replacement of claim 4, wherein the cuff frame is configured as a flat cone shape having a diameter R of 50-70 mm, a diameter r of 20-30 mm, and a height of 20-40 mm. ### Claim 7 (depends on 4) The transcatheter heart valve replacement of claim 4, wherein the cuff frame has an inner wall and an outer wall, said inner wall having a biocompatible material comprising pericardial tissue, and said outer wall having a biocompatible material comprising a woven synthetic polyester material. ### Claim 8 (depends on 4) The transcatheter heart valve replacement of claim 4, wherein the cuff frame is configured as an hourglass flat conical shape having a top diameter R1 of 50-70 mm, a bottom diameter R2 of 50-70 mm, an internal diameter r of 20-30 mm, and a height of 20-50 mm. ### Claim 9 (depends on 4) The transcatheter heart valve replacement of claim 4, wherein the collapsible flow control member has an internal diameter of 20-30 mm and a height of 30-80 mm, said member comprising three substantially flat rectangular panels of pericardial material joined to form a rounded triangular cylinder. ### Claim 10 (depends on 4) The transcatheter heart valve replacement claim 4, wherein the transcatheter heart valve replacement is compressible and fits when compressed within the internal diameter of a transcatheter implantation catheter having an internal diameter less than 22 Fr (7.33 mm) to 34 Fr (9.33 mm). ### Claim 11 (depends on 4) The transcatheter heart valve replacement of claim 4, wherein the collapsible flow control member is supported with one or more longitudinal supports integrated into a fabric or material of the collapsible flow control member, the one or more longitudinal supports selected from rigid or semi-rigid ribs, rigid or semi-rigid battons, rigid or semi-rigid panels, and combination thereof. ### Claim 12 (depends on 4) The transcatheter heart valve replacement of claim 4, wherein one or more of the tissue anchors are selected from the group consisting of: a helical coil, a screw, a dart, a pin, and a fastener means. ### Claim 13 (depends on 1) A method for securing a transcatheter heart valve prosthesis within a heart, the method comprising the steps: (i) advancing a procedure guide wire into a ventricle of a heart; (ii) advancing a 22 Fr-34 Fr steerable catheter over the procedure guide wire to deliver a compressed transcatheter heart valve prosthesis of claim 1 to an atrium of the ventricle of the heart; (iii) advancing the catheter to the valve annulus and releasing the self-expanding atrial sealing collar from within the catheter; and (iv) advancing and anchoring a tissue anchor through the cuff wire frame and into the annular tissue.