# US 12,396,712 B2 · Suturing clip > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,396,712 B2 - Document ID: US12396712B2 - Status: Granted - Kind: B2 - Application number: 17/050,444 - Filed: 2019-04-24 - Published: 2021-05-13 - Granted: 2025-08-26 - Earliest claimed: 2018-04-25 - Assignees: Endomatic Ltd. - Applicants: Endomatic Ltd. - Inventors: Dvir Keren; Boaz Schwarz; Shimrit Markovitz - Web page: https://patentgrep.com/patent/US12396712B2 ## CPC - A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)} - A61B 17/12031: {complete occlusion} - A61B 17/064: Surgical staples, {i.e. penetrating the tissue} - A61B 17/12122: {within the heart (for closing a cardiac septal defect A61B17/0057)} - A61B 17/12172: {having a pre-set deployed three-dimensional shape (methods of manufacturing A61B2017/00526)} - A61B 17/1227: {Spring clips} - A61B 17/1285: {for minimally invasive surgery} - A61B 17/0643: {with separate closing member, e.g. for interlocking with staple} - A61B 2017/00584: {Clips} - A61B 2017/00592: {Elastic or resilient implements} - A61B 2017/00623: {Introducing or retrieving devices therefor} - A61B 2017/00632: {Occluding a cavity, i.e. closing a blind opening} - A61B 2017/0641: {having at least three legs as part of one single body} - A61B 2017/1205: {Introduction devices} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Suturing clips which may be guided to a heart by a trans-vascular/trans-septal approach, and yet operate to close the left atrial appendage (LAA) from a position located entirely within the LAA are described. Arms of suturing clips constructed of a superelastic alloy are expanded from a catheter delivery system, anchored within the LAA and/or ostium of the LAA, and then collapsed again to a suturing configuration. Collapse is optionally by a reverting mechanism, wherein arms are constrained to collapse back in a direction reverse to their original expansion; or by an everting mechanism, wherein arm portions move past their expanded position to close with each other on an opposite side of their original position. In some embodiments, delivery systems include further elements to assist in clip placement at the LAA, for example a spreader for spreading the LAA, and/or a stopper for preventing deep intrusion to the LAA. ## Claims ### Claim 1 A suturing clip for closing a body lumen aperture defining a passageway into a portion of the body lumen, the passageway extending between a first side of the aperture to a second side of the aperture, and the suturing clip comprising: a core comprising a longitudinal axis extending from a proximal side of said core to a distal side of said core; a plurality of arms each joined at a basal side of the arm to a-said core of the suturing clip; and a respective anchor at a terminal end of each arm; wherein the suturing clip is configured to convert between: a collapsed delivery configuration expandable to attach the anchors to tissue within the portion of the body lumen and on the second side of the aperture, a collapsed suturing configuration shaped to re-position the anchors where they close the aperture and the passageway in directions leading both into and out of the portion of the body lumen, wherein the anchors close the passageway by movement of the attached tissue to a position that isolates the suturing clip from the first side of the body lumen aperture; wherein the suturing clip, in the collapsed delivery configuration, is configured to attach to a delivery mount and be advanced on the delivery mount from the first side of the body lumen aperture by distal movement along said longitudinal axis of the suturing clip; said distal movement being in a direction from said proximal side of said core to said distal side of said core; wherein said arms of the suturing clip, in said collapsed delivery configuration, extend in a proximal-distal configuration; where in said proximal-distal configuration said arms extend in a direction from said proximal side of said core to said distal side of said core in relation to said core and along said longitudinal axis; wherein said arms of the suturing clip are configured to transition from a proximal-distal configuration to a distal-proximal configuration; where in said distal-proximal configuration said arms extend in a direction from said distal side of said core to said proximal side of said core in relation to said core and during a transition between said collapsed delivery configuration to said collapsed suturing configuration; and wherein the suturing clip, in the collapsed suturing configuration, is positioned with the core and arms both isolated on the second side of the aperture. ### Claim 2 (depends on 1) The suturing clip of claim 1, wherein the suturing clip resiliently self-expands from the collapsed delivery configuration to an expanded anchoring configuration having a maximum diameter at least 5x larger than a maximum diameter of the suturing clip in the collapsed delivery configuration. ### Claim 3 (depends on 1) The suturing clip of claim 1, wherein the delivery mount is configured to be detached from the suturing clip in the collapsed suturing configuration and withdrawn through tissue closed by the anchors of the suturing clip to the first side of the closed tissue opposite the suturing clip isolated on the second side. ### Claim 4 (depends on 2) The suturing clip of claim 2, wherein the suturing clip is configured to resiliently self-collapse from the expanded anchoring configuration to the collapsed suturing configuration. ### Claim 5 (depends on 1) The suturing clip of claim 1, sized to be sheathed by a sheathing lumen of a trans-vascular catheter; and wherein the suturing clip in the collapsed delivery configuration is sheathed within the sheathing lumen. ### Claim 6 (depends on 5) The suturing clip of claim 5, wherein: the suturing clip is configured to resiliently self-expand from the collapsed delivery configuration to an expanded anchoring configuration upon a partial unsheathing from the sheathing lumen; and the suturing clip is configured to resiliently self-collapse from the expanded anchoring configuration to the collapsed suturing configuration upon a further unsheathing from the sheathing lumen. ### Claim 7 (depends on 6) The suturing clip of claim 6, wherein the suturing clip is configured to evert during converting between the collapsed delivery configuration and the expanded anchoring configuration, so that a side of the anchors which face radially inward in the collapsed delivery configuration faces outward in the expanded anchoring configuration. ### Claim 8 (depends on 6) The suturing clip of claim 6, having a proximal-to-distal axis, wherein the suturing clip is configured to evert during converting between the collapsed delivery configuration and the collapsed suturing configuration, so that a portion of the arms which is initially on a distal side of the core moves to a proximal side of the core. ### Claim 9 (depends on 6) The suturing clip of claim 6, wherein conversion from the expanded anchoring configuration to the collapsed suturing configuration comprises a reverting movement of the arms in a direction opposite a direction of their expansion from the collapsed delivery configuration to the expanded anchoring configuration. ### Claim 10 (depends on 5) The suturing clip of claim 5, further comprising a spreader, said spreader separately actuatable to extend laterally from the trans-vascular catheter, insert to the body lumen aperture, and configured to contact tissue of the body lumen aperture with grips to set a position of the sheathing lumen from which the suturing clip is deployed. ### Claim 11 (depends on 1) The suturing clip of claim 1, wherein the anchors, in the collapsed suturing configuration, define a zigzag pattern extending along a band of closure of the closed tissue. ### Claim 12 (depends on 1) The suturing clip of claim 1, wherein a first plurality of the arms extends from the core via a trunk which is shared in common by the plurality of the arms. ### Claim 13 (depends on 12) The suturing clip of claim 12, comprising a second plurality of arms, and wherein arms of the first plurality are configured to interdigitate with arms of the second plurality in the collapsed suturing configuration. ### Claim 14 (depends on 1) The suturing clip of claim 1, comprising a torsion bar, wherein at least one of the arms is mounted to at least one side of the torsion bar, and the torsion bar is configured to twist to move the at least one of the arms from the collapsed delivery configuration toward the collapsed suturing configuration. ### Claim 15 (depends on 1) The suturing clip of claim 1, wherein the anchors are positioned on a radially inward side of the arms in the collapsed delivery configuration, and move to a radially outward side of the arms during movement of the arms toward the collapsed suturing configuration. ### Claim 16 A method of closing a body lumen aperture defining a passageway into a portion of the body lumen, the passageway extending between a first side of the aperture to a second side of the aperture, the method comprising: advancing a suturing clip attached to a delivery mount through the body lumen aperture from the first side of aperture to the second side of the aperture; said suturing clip comprising a longitudinal axis extending from a proximal side of said suturing clip to a distal side of said suturing clip; expanding the suturing clip at least partially on the second side of the body lumen aperture; anchoring tissue defining a perimeter of the body lumen aperture to anchors of the suturing clip; and collapsing the suturing clip so that the anchors close the body lumen aperture and the passageway in directions leading both into and out of the portion of the body lumen while the suturing clip remains on the second side of the closed aperture and isolated from the first side of the closed aperture; wherein a transition from said expanding to said collapsing comprises transitioning arms of said suturing clip from a proximal-distal configuration to a distal-proximal configuration; where in said proximal-distal configuration said arms extend in a direction from said proximal side of said suturing clip to said distal side of said suturing clip in relation to said suturing clip and along said longitudinal axis; and where in said distal-proximal configuration said arms extend in a direction from said distal side of said suturing clip to said proximal side of said suturing clip in relation to said suturing clip. ### Claim 17 (depends on 16) The method of claim 16, wherein the body lumen aperture is an ostium of a left atrial appendage. ### Claim 18 (depends on 16) The method of claim 16, wherein the collapsing comprises moving the anchors into a zigzag configuration. ### Claim 19 (depends on 16) The method of claim 16, wherein the collapsing comprises moving the anchors toward a common radial center. ### Claim 20 (depends on 16) The method of claim 16, wherein the collapsing comprises moving at least one of the anchors radially outward, while at least one of the anchors moves radially inward. ### Claim 21 (depends on 1) The suturing clip of claim 1, wherein the arms are sized to attach the anchors to aperture tissue of a left atrial appendage, and configured to collapse to a shape that closes the aperture the left atrial appendage.