# US 11,304,715 B2 · Methods and devices for tissue grasping and assessment > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,304,715 B2 - Document ID: US11304715B2 - Status: Granted - Kind: B2 - Application number: 16/912,361 - Filed: 2020-06-25 - Published: 2020-10-15 - Granted: 2022-04-19 - Earliest claimed: 2004-09-27 - Assignees: Evalve, Inc. - Applicants: Evalve, Inc. - Inventors: Eric A. Goldfarb; Troy L. Thornton; Alfred H. Raschdorf; Jaime E. Sarabia; John P. Madden; Ferolyn T. Powell; Brian B. Martin; Sylvia Erickson; Jan Komtebedde; Yen C. Liao - Web page: https://patentgrep.com/patent/US11304715B2 ## CPC - 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 17/08: Wound clamps {or clips, i.e. not or only partly penetrating the tissue (suture bridges A61B17/0466); Devices for bringing together the edges of a wound} - A61B 17/29: Forceps for use in minimally invasive surgery - A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition} - A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)} - A61B 2017/00243: {cardiac} - A61B 2017/00783: {Valvuloplasty} - A61B 2017/081: {Tissue approximator (A61B2017/1103, A61B17/8866 take precedence)} - A61B 2017/22088: {ultrasound absorbing, drug activated by ultrasound} - A61B 2017/22089: {Gas-bubbles} - A61B 2017/22098: {Decalcification of valves} - A61B 2017/2825: {Inserts of different material in jaws} - A61B 2017/2926: {Details of heads or jaws} - A61B 2017/2931: {with releasable head} - A61B 2017/306: {holding by means of suction} - A61B 2090/3908: {Soft tissue, e.g. breast tissue} - A61B 2090/3925: {ultrasonic} - A61F 2/2466: {Delivery devices therefor} - A61F 2/2478: {Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands} - A61F 2/2487: {Devices within the heart chamber, e.g. splints} - A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol - A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes - A61F 2230/001: Figure-8-shaped, e.g. hourglass-shaped - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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 Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation. ## Claims ### Claim 1 A fixation device for fixation of leaflets of a heart valve, comprising: a first distal element and a second distal element; a first proximal element moveable relative to the first distal element between a first position and a second position to grasp a first leaflet in a first target area defined by the first proximal element and the first distal element; a second proximal element moveable relative to the second distal element between a first position and a second position to grasp a second leaflet in a second target area defined by the second proximal element and the second distal element; a first indicator coupled with the first distal element to indicate a presence of the first leaflet in the first target area, the first indicator comprising one or more wire loops, wherein the first indicator extends into the first target area and is configured to at least one of change shape or change orientation by the presence of the first leaflet grasped within the first target area; and a second indicator coupled with the second distal element to indicate a presence of the second leaflet in the second target area, the second indicator comprising one or more wire loops, wherein the second indicator extends into the second target area and is configured to at least one of change shape or change orientation by the presence of the second leaflet grasped within the second target area. ### Claim 2 (depends on 1) The fixation device of claim 1 wherein the first indicator is configured to change shape by the presence of the first leaflet grasped within the first target area; and wherein the second indicator is configured to change shape by the presence of the first leaflet grasped within the first target area. ### Claim 3 (depends on 1) The fixation device of claim 1 wherein the first indicator is configured to change orientation by the presence of the first leaflet grasped within the first target area; and wherein the second indicator is configured to change orientation by the presence of the second leaflet grasped within the second target area. ### Claim 4 (depends on 1) The fixation device of claim 1, wherein the first indicator comprises an enhanced visibility material viewable using a visualization technique; and wherein the second indicator comprises an enhanced visibility material viewable using the visualization technique. ### Claim 5 (depends on 4) The fixation device of claim 4, wherein the first distal element comprises an enhanced visibility material viewable using the visualization technique; and wherein the second distal element comprises an enhanced visibility material viewable using the visualization technique. ### Claim 6 (depends on 4) The fixation device of claim 4, wherein the visualization technique comprises at least one of fluoroscopy, ultrasound, and echocardiography. ### Claim 7 (depends on 1) The fixation device of claim 1, wherein the first indicator is configured to be pressed toward the first distal element by the presence of the first leaflet grasped within the first target area; and wherein the second indicator is configured to be pressed toward the second distal element by the presence of the second leaflet grasped within the second target area. ### Claim 8 (depends on 1) The fixation device of claim 1, wherein the one or more wire loops of the first indicator comprise an enhanced visibility material viewable using a visualization technique; and wherein the one or more wire loops of the second indicator comprise an enhanced visibility material viewable using the visualization technique. ### Claim 9 (depends on 1) The fixation device of claim 1, wherein the one or more wire loops of the first indicator are biased towards the first proximal element; and wherein the one or more wire loops of the second indicator are biased towards the second proximal element. ### Claim 10 (depends on 1) The fixation device of claim 1, wherein the one or more wire loops of the first indicator are configured to be pressed toward the first distal element by the presence of the first leaflet grasped within the first target area; and wherein the one or more wire loops of the second indicator are configured to be pressed toward the second distal element by the presence of the second leaflet grasped within the second target area.