# US 12,109,115 B2 · Wide clip with deformable width > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,109,115 B2 - Document ID: US12109115B2 - Status: Granted - Kind: B2 - Application number: 17/124,259 - Filed: 2020-12-16 - Published: 2021-06-24 - Granted: 2024-10-08 - Earliest claimed: 2019-12-18 - Assignees: Evalve, Inc. - Applicants: Evalve, Inc. - Inventors: Chad Abunassar; Santosh Prabhu; Casey Barbarino; Jessie Garcia; Gabriel Gonzales; Brandon Chu; Tamer M. Mahmoud; Michael Wei - Web page: https://patentgrep.com/patent/US12109115B2 ## CPC - A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition} - A61B 17/122: Clamps or clips, e.g. for the umbilical cord {(for the vas deferens A61F6/206)} - 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 2/2466: {Delivery devices therefor} - A61F 2/2445: {Annuloplasty rings in direct contact with the valve annulus} - A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol - A61F 2220/0091: connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type - 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) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Fixation device for fixation of leaflets of a heart valve includes a central assembly and at least one arm moveably coupled relative to the central assembly. The at least one arm includes a deformable frame having a first end and a second end and a longitudinal axis defined therebetween, the second end being moveable between a closed position and an open position. The deformable frame further includes first and second deformable flex portions, each flex portion extending along a respective lateral side of the deformable frame and having a deformed condition and an undeformed condition, and each flex portion having an outer lateral edge. The at least one arm has a maximum deformed arm lateral cross-dimension with the flex portions in the deformed condition. ## Claims ### Claim 1 A fixation device for fixation of leaflets of a heart valve comprising: a central assembly; at least one arm moveably coupled relative to the central assembly, the at least one arm comprising: a deformable frame having a first end and a second end and a longitudinal axis defined therebetween, the second end being moveable between a closed position and an open position, the deformable frame further comprising first and second deformable flex portions, each flex portion extending along a respective lateral side of the deformable frame and having a deformed condition and an undeformed condition, each flex portion having an outer lateral edge, wherein the first flex portion comprises a deformable first flank member extending longitudinally along a first lateral side of the deformable frame and the second flex portion comprises a deformable second flank member extending longitudinally along a second lateral side of the deformable frame, the first and second flank members in the deformed condition being aligned generally parallel with the longitudinal axis, wherein the deformable frame further comprises a first strut extending laterally from the first flank member to the second flank member, the first strut comprising a hinge portion having a compressed configuration with the deformable frame in the deformed condition and an extended configuration with the deformable frame in the undeformed condition, wherein the at least one arm has a maximum deformed arm lateral cross-dimension with the flex portions in the deformed condition and a maximum undeformed arm width defined between the outer lateral edge of the first flex portion and the outer lateral edge of the second flex portion in the undeformed condition, wherein the maximum undeformed arm width is greater than the maximum deformed arm lateral cross-dimension; and at least one gripping element moveable relative to the at least one arm to capture a native leaflet therebetween. ### Claim 2 (depends on 1) The fixation device of claim 1, wherein the deformable frame further comprises a trough defined along the longitudinal axis, and further wherein the first flex portion comprises a deformable first wing extension extending laterally from a first lateral side of the trough and the second flex portion comprises a deformable second wing extension extending laterally from a second lateral side of the trough. ### Claim 3 (depends on 2) The fixation device of claim 2, wherein the first and second wing extensions each has a second end edge extending laterally from the second end of the deformable frame at a second end angle defined between the second end edge and the longitudinal axis, wherein the second end angle is between 15 and 45 degrees. ### Claim 4 (depends on 2) The fixation device of claim 2, wherein the deformable frame, including the trough and the first and second wing extensions, is a single piece construction. ### Claim 5 (depends on 2) The fixation device of claim 2, wherein the first and second wing extensions each includes at least one notch defined along a respective lateral edge thereof. ### Claim 6 (depends on 2) The fixation device of claim 2, wherein the first and second wing extensions each comprises an open wing extension frame defining a wing opening therethrough in plan view. ### Claim 7 (depends on 1) The fixation device of claim 1, wherein the maximum undeformed arm width is proximate the second end of the deformable frame. ### Claim 8 (depends on 7) The fixation device of claim 7, wherein the deformable frame further comprises a trough defined along the longitudinal axis, the trough having a greater width between opposing lateral sides of the trough along a length of the arm proximate the maximum undeformed arm width. ### Claim 9 (depends on 8) The fixation device of claim 8, wherein the at least one gripping element has a first end coupled to a portion of the fixation device and a second end moveable relative to the at least one arm, wherein the gripping element has a greater width proximate the second end of the gripping element. ### Claim 10 (depends on 2) The fixation device of claim 2, wherein the first and second wing extensions are made of shape memory material. ### Claim 11 (depends on 1) The fixation device of claim 1, wherein the first and second flank members in the undeformed condition each having at least a length thereof extending outwardly away from the longitudinal axis. ### Claim 12 (depends on 1) The fixation device of claim 1, wherein the hinge portion is biased toward the extended condition. ### Claim 13 (depends on 1) The fixation device of claim 1, wherein the deformable frame further comprises an end strut extending laterally from the first flank member to the second flank member at the second end of the deformable frame, the end strut comprising a hinge portion having a compressed configuration with the deformable frame in the deformed condition and an extended configuration with the deformable frame in the undeformed condition, the first strut being spaced longitudinally from the end strut. ### Claim 14 A fixation device for fixation of leaflets of a heart valve comprising: a central assembly; at least one arm moveably coupled relative to the central assembly, the at least one arm comprising: a deformable frame having a first end and a second end and a longitudinal axis defined therebetween, the second end being moveable between a closed position and an open position, the deformable frame further comprising first and second deformable flex portions, each flex portion extending along a respective lateral side of the deformable frame and having a deformed condition and an undeformed condition, each flex portion having an outer lateral edge, wherein the first flex portion comprises a deformable first flank member extending longitudinally along a first lateral side of the deformable frame and the second flex portion comprises a deformable second flank member extending longitudinally along a second lateral side of the deformable frame, the first and second flank members in the deformed condition being aligned generally parallel with the longitudinal axis, wherein the deformable frame further comprises: a first strut extending laterally from the first flank member toward the second flank member and a second strut extending laterally from the second flank member toward the first strut member, wherein the at least one arm has a maximum deformed arm lateral cross-dimension with the flex portions in the deformed condition and a maximum undeformed arm width defined between the outer lateral edge of the first flex portion and the outer lateral edge of the second flex portion in the undeformed condition, wherein the maximum undeformed arm width is greater than the maximum deformed arm lateral cross-dimension; and at least one gripping element moveable relative to the at least one arm to capture a native leaflet therebetween. ### Claim 15 (depends on 14) The fixation device of claim 14, wherein the deformable frame further comprises an end strut extending laterally from the first flank member to the second flank member at the second end of the deformable frame, the end strut comprising a hinge portion having a compressed configuration with the deformable frame in the deformed condition and an extended configuration with the deformable frame in the undeformed condition. ### Claim 16 (depends on 14) The fixation device of claim 14, wherein the first and second struts are in overlapping sliding arrangement for movement relative each other between the deformed condition and the undeformed condition. ### Claim 17 (depends on 14) The fixation device of claim 14, wherein the first and second struts are laterally spaced from each other with the deformable frame in the undeformed condition, the fixation device further comprising a middle support member extending parallel with the longitudinal axis between the first and second flank members. ### Claim 18 A fixation device for fixation of leaflets of a heart valve comprising: a central assembly; at least one arm moveably coupled relative to the central assembly, the at least one arm comprising: a deformable frame having a first end and a second end and a longitudinal axis defined therebetween, the second end being moveable between a closed position and an open position, the deformable frame further comprising first and second deformable flex portions, each flex portion extending along a respective lateral side of the deformable frame and having a deformed condition and an undeformed condition, each flex portion having an outer lateral edge, wherein the first flex portion comprises a deformable first flank member extending longitudinally along a first lateral side of the deformable frame and the second flex portion comprises a deformable second flank member extending longitudinally along a second lateral side of the deformable frame, the first and second flank members in the deformed condition being aligned generally parallel with the longitudinal axis, wherein the deformable frame comprises a plurality of first struts extending laterally from the first flank member toward the second flank member and a plurality of second struts extending laterally from the second flank member toward the first strut member, the plurality of first struts and the plurality of second struts configured to interlock with each other in the deformed condition and release from each other in the undeformed condition, wherein the at least one arm has a maximum deformed arm lateral cross-dimension with the flex portions in the deformed condition and a maximum undeformed arm width defined between the outer lateral edge of the first flex portion and the outer lateral edge of the second flex portion in the undeformed condition, wherein the maximum undeformed arm width is greater than the maximum deformed arm lateral cross-dimension; and at least one gripping element moveable relative to the at least one arm to capture a native leaflet therebetween. ### Claim 19 (depends on 14) The fixation device of claim 14, wherein the first and second flank members each has a tapered portion proximate the second end of the deformable frame. ### Claim 20 (depends on 14) The fixation device of claim 14, the at least one arm further comprising: an expandable mesh portion extending between the first and second flank members. ### Claim 21 (depends on 18) The fixation device of claim 18, wherein the first and second flank members comprise shape memory material.