# US 11,998,449 B2 · Repair clip for variable tissue thickness > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,449 B2 - Document ID: US11998449B2 - Status: Granted - Kind: B2 - Application number: 17/933,667 - Filed: 2022-09-20 - Published: 2023-01-12 - Granted: 2024-06-04 - Earliest claimed: 2019-10-11 - Assignees: Evalve, Inc. - Applicants: Evalve, Inc. - Inventors: Chad Abunassar - Web page: https://patentgrep.com/patent/US11998449B2 ## CPC - A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition} - A61F 2/2466: {Delivery devices therefor} - A61F 2220/0008: Fixation appliances for connecting prostheses to the body - A61F 2230/0093: Umbrella-shaped, e.g. mushroom-shaped - A61F 2250/0004: adjustable - A61F 2250/0008: for adjusting a position by translation along an axis or two perpendicular axes - A61F 2250/0009: for adjusting thickness - A61F 2250/0012: for adjusting elasticity, flexibility, spring rate or mechanical tension - 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 Fixation device for fixation of leaflets of a heart valve includes an elongate central member defining a longitudinal axis of the fixation device and first and second arms rotatable about at least one arm hinge point between an open position and a closed position. The fixation device further includes a first gripping element rotatable about a first gripping element axis of rotation to capture a first leaflet of a heart valve between the first gripping element and the first arm. The fixation device further includes a second gripping element rotatable about a second gripping element axis of rotation to capture a second leaflet of a heart valve between the second gripping element and the second arm. At least one of the first gripping element axis of rotation and the second gripping element axis of rotation is variably offset from the arm hinge point by an axis offset distance defined along the longitudinal axis. ## Claims ### Claim 1 A fixation device for fixation of leaflets of a heart valve comprising: an elongate central member defining a longitudinal axis of the fixation device and at least one channel extending along the longitudinal axis; first and second arms rotatable about at least one arm hinge point between an open position and a closed position; a first gripping element rotatable about a first gripping element axis of rotation to capture a first leaflet of a heart valve between the first gripping element and the first arm; a second gripping element rotatable about a second gripping element axis of rotation to capture a second leaflet of a heart valve between the second gripping element and the second arm, wherein at least one of the first gripping element axis of rotation and the second gripping element axis of rotation is variably adjustable along the channel of the elongate central member from the arm hinge point by an axis offset distance defined along the longitudinal axis, wherein the at least one of the first and second gripping elements is operatively coupled to the at least one channel of the elongate central member and includes a flex portion defining the respective gripping element axis of rotation. ### Claim 2 (depends on 1) The device of claim 1, wherein the at least one channel of the elongate central member is a first and second channel, the first gripping element is operatively coupled to the first channel, and the second gripping element is operatively coupled to the second channel. ### Claim 3 (depends on 1) The device of claim 1, wherein each of the first gripping element axis of rotation and the second gripping element axis of rotation is variably offset from the arm hinge point. ### Claim 4 (depends on 3) The device of claim 3, wherein the axis offset distance includes a first axis offset distance and a second axis offset distance, the first axis offset distance is defined between the arm hinge point and the first gripping element axis of rotation, and the second axis offset distance is defined between the arm hinge point and the second gripping element axis of rotation, wherein the first axis offset distance is independent of the second axis offset distance. ### Claim 5 (depends on 1) The device of claim 1, wherein the first gripping element axis of rotation is parallel to and spaced along the longitudinal axis from the second gripping element axis of rotation. ### Claim 6 (depends on 1) The device of claim 1, wherein the device further including at least one shim disposed in the at least one channel to limit the axis offset distance from a maximum axis offset distance. ### Claim 7 (depends on 1) The device of claim 1, wherein the at least one of the first gripping element axis of rotation and the second gripping element axis of rotation is biased away from the at least one arm hinge point. ### Claim 8 (depends on 1) The device of claim 1, wherein the flex portion includes a first flex portion and a second flex portion, and the first gripping element axis of rotation is comprised of the first flex portion and the second gripping element axis of rotation is comprised of the second flex portion, the first and second flex portions each being defined along a length of the respective gripping element. ### Claim 9 (depends on 1) The device of claim 1, wherein the flex portion is a compliant hinge configured to variably shift the axis offset distance toward or away from the at least one arm hinge point depending on a thickness of a captured native leaflet of the heart valve. ### Claim 10 (depends on 1) The device of claim 1, wherein at least one arm includes a trough having a trough bottom defining a trough reference plane, and further wherein the arm hinge point is offset from the trough reference plane by a trough offset distance defined along the longitudinal axis. ### Claim 11 (depends on 1) The device of claim 1, wherein the fixation device is releasably coupled to a distal end of a delivery shaft. ### Claim 12 (depends on 7) The fixation device of claim 7, further comprising a spring, the spring biasing the at least one of the first gripping element axis of ration and the second gripping element axis of rotation away from the at least one arm hinge point. ### Claim 13 A fixation device for fixation of leaflets of a heart valve comprising: an elongate central member defining a longitudinal axis of the fixation device and having a plurality of pin holes defined therein, the plurality of pin holes being spaced apart longitudinally along the elongate central member; first and second arms rotatable about at least one arm hinge point between an open position and a closed position; a first gripping element rotatable about a first gripping element axis of rotation to capture a first leaflet of a heart valve between the first gripping element and the first arm; a second gripping element rotatable about a second gripping element axis of rotation to capture a second leaflet of a heart valve between the second gripping element and the second arm, wherein at least one of the first gripping element axis of rotation and the second gripping element axis of rotation is defined by a flex portion of the respective gripping element and is variably offset from the arm hinge point by an axis offset distance defined along the longitudinal axis, and wherein the at least one of the first gripping elements includes at least one connector pin configured to engage with any one of the plurality of pin holes of the elongate central member. ### Claim 14 (depends on 12) The device of claim 12, wherein the first gripping element and the second gripping element are operatively coupled together whereby the first gripping element axis of rotation and the second gripping element axis of rotation define a single axis of rotation. ### Claim 15 (depends on 13) The device of claim 13, wherein the axis offset distance between the at least one hinge point and the at least one of the first gripping element axis of rotation and the second gripping element axis of rotation is incrementally selectable by engaging the at least one connector pin with any one of the plurality of pin holes. ### Claim 16 A fixation device for fixation of leaflets of a heart valve comprising: an elongate central member defining a longitudinal axis of the fixation device; first and second arms rotatable about at least one arm hinge point between an open position and a closed position; a first gripping element having a first end connected to one of the elongate central member and the first arm, the first gripping element also having a first connection portion connected to the elongate central member and being disposed between the first end and a second end of the first gripping element, the first connection portion having a first flex portion defining a first gripping element axis of rotation such that the first gripping element is rotatable about the first gripping element axis of rotation to capture a first leaflet of a heart valve between the first gripping element and the first arm; and a second gripping element rotatable about a second gripping element axis of rotation to capture a second leaflet of a heart valve between the second gripping element and the second arm; wherein the first gripping element axis of rotation is variably offset from the at least one arm hinge point by a first axis offset distance defined along the longitudinal axis; and wherein the first flex portion is a compliant hinge configured to variably change the first axis offset distance depending on a thickness of a captured native leaflet of the heart valve. ### Claim 17 (depends on 16) The device of claim 16, wherein the first end of the gripping element having the compliant hinge is connected to the elongate central member. ### Claim 18 (depends on 16) The device of claim 16, wherein the first end of the gripping element having the compliant hinge is connected to the corresponding arm. ### Claim 19 (depends on 16) The fixation device of claim 16, wherein the compliant hinge has a zig-zag configuration configured to elongate the first gripping element depending on the thickness of the captured leaflet of the heart valve. ### Claim 20 (depends on 16) The fixation device of claim 16, wherein the second gripping element includes a second connection portion connected to the elongate central member, the second connection portion having a second flex portion defining the second gripping element axis of rotation, the second flex portion being a compliant hinge configured to variable change a second axis offset distance of the second gripping element depending on a thickness of another capture native leaflet of the heart valve.