# US 11,026,695 B2 · Devices and methods for excluding the left atrial appendage > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,026,695 B2 - Document ID: US11026695B2 - Status: Granted - Kind: B2 - Application number: 15/795,083 - Filed: 2017-10-26 - Published: 2018-05-03 - Granted: 2021-06-08 - Earliest claimed: 2016-10-27 - Assignees: Conformal Medical, Inc. - Applicants: Conformal Medical, Inc. - Inventors: David A. Melanson; Andy H. Levine; James H. Loper; Michael T. Radford; Carol Devellian; Aaron V. Kaplan; Ronald B. Lamport - Web page: https://patentgrep.com/patent/US11026695B2 ## CPC - A61B 17/12122: {within the heart (for closing a cardiac septal defect A61B17/0057)} - A61B 17/12031: {complete occlusion} - A61B 17/12131: {characterised by the type of occluding device} - A61B 17/12145: {having a pre-set deployed three-dimensional shape (methods of manufacturing A61B2017/00526)} - A61B 17/1215: {comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated} - A61B 17/12172: {having a pre-set deployed three-dimensional shape (methods of manufacturing A61B2017/00526)} - A61B 17/12177: {comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated} - A61B 17/12181: {formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices} - A61M 29/00: Dilators with or without means for introducing media, e.g. remedies - A61B 17/00491: {Surgical glue applicators} - A61B 17/12036: {partial occlusion} - A61B 17/12136: {Balloons} - A61B 17/1219: {expandable in contact with liquids} - A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)} - A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive} - A61B 2017/00022: {Sensing or detecting at the treatment site} - A61B 2017/00221: {with wireless transmission of data, e.g. by infrared radiation or radiowaves} - A61B 2017/00526: {Methods of manufacturing} - A61B 2017/00853: {low friction, hydrophobic and corrosion-resistant fluorocarbon resin coating (ptf, ptfe, polytetrafluoroethylene)} - A61B 2017/00893: {pharmaceutically effective} - A61B 2017/00898: {expandable upon contact with fluid} - A61B 2017/00951: {adhesive} - A61B 2017/1205: {Introduction devices} - A61B 2017/12054: {Details concerning the detachment of the occluding device from the introduction device} - A61B 2017/320069: {for ablating tissue} - A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array} - A61B 2018/0022: {Balloons} - A61B 2018/00577: {Ablation} - A61B 2090/064: {for measuring force, pressure or mechanical tension} - A61B 2090/3966: {Radiopaque markers visible in an X-ray image} - A61M 2205/04: implanted - A61M 2205/3331: Pressure; Flow - A61N 1/395: {for treating atrial fibrillation} - A61N 1/39622: {Pacing therapy} - A61N 7/022: {intracavitary} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract Devices and methods are described for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow to prevent blood from clotting within the LAA and subsequently embolizing, particularly in patients with atrial fibrillation. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body carried by the frame. The device may have a thromboresistant cover at a proximal end and a thromboresistant coating on the foam body. The frame may have recapture struts inclining radially outwardly in the distal direction from a central hub. The frame may have axially extending side wall struts, with adjacent pairs of side wall struts joined at one or more apexes. Anchors extend from the frame to engage tissue. The anchors can also be reversible to allow retraction of the anchors and repositioning or retrieval of the device. ## Claims ### Claim 1 A left atrial appendage occlusion device, comprising: a conformable, tubular foam body, having a closed proximal end and a distal end; the body including a compressible side wall extending between the proximal end and the distal end, and defining a central cavity; an expandable support coupled with the body, configured to compress the side wall against a wall of a left atrial appendage; and anchors having tips configured to extend radially outwardly and incline proximally through the side wall to penetrate tissue of the left atrial appendage. ### Claim 2 (depends on 1) A left atrial appendage occlusion device as in claim 1, wherein the compressible side wall has an uncompressed thickness of at least about 0.5 mm. ### Claim 3 (depends on 1) A left atrial appendage occlusion device as in claim 1, wherein the compressible side wall has an uncompressed thickness of at least about 1.5 mm. ### Claim 4 (depends on 1) A left atrial appendage occlusion device as in claim 1, wherein the compressible side wall extends in a distal direction beyond a distal end of the support by at least about 2 mm in an unconstrained, expanded state. ### Claim 5 (depends on 1) A left atrial appendage occlusion device as in claim 1, wherein the compressible side wall comprises a foam having a plurality of interconnected reticulations and voids, and further comprising a PTFE coating on at least some of the interconnected reticulations. ### Claim 6 (depends on 1) A left atrial appendage occlusion device as in claim 1, wherein the closed proximal end comprises a foam end wall. ### Claim 7 (depends on 6) A left atrial appendage occlusion device as in claim 6, wherein the foam end wall further comprises a cover. ### Claim 8 (depends on 7) A left atrial appendage occlusion device as in claim 7, wherein the cover comprises ePTFE. ### Claim 9 (depends on 1) A left atrial appendage occlusion device as in claim 1, wherein the expandable support is self expandable. ### Claim 10 (depends on 1) A left atrial appendage occlusion device as in claim 1, wherein the expandable support is in the central cavity. ### Claim 11 (depends on 1) A left atrial appendage occlusion device as in claim 1, wherein the tubular foam body is substantially cylindrical in an unconstrained, expanded state. ### Claim 12 A self-expandable, atraumatic occlusion device configured to conform to the side wall of a left atrial appendage, comprising: a compressible open cell foam body, having a tubular foam side wall and a central cavity; a self-expandable support within the cavity; anchors having tips configured to extend radially outwardly and incline proximally through the side wall to penetrate tissue of the left atrial appendage; and a proximal end wall forming a closed proximal end on the foam body; wherein the proximal end wall is positioned proximally of a proximal end of the support, and the foam side wall extends distally beyond the distal end of the support to form a distal, atraumatic bumper for preventing contact between the support and a wall of the left atrial appendage in an implantation in which a central longitudinal axis of the occlusion device is non-parallel to a primary longitudinal axis of the left atrial appendage. ### Claim 13 A left atrial appendage occlusion device, comprising: an expandable tubular foam cup having a closed proximal end, a distal end, a tubular side wall and a proximal end wall, the side wall having a thickness of at least about 1.0 mm and a porosity of at least about 85% open void content; an expandable frame configured to press the side wall into conforming contact with a wall of the left atrial appendage; and anchors having tips configured to extend radially outwardly and incline proximally through the side wall to penetrate tissue of the left atrial appendage. ### Claim 14 (depends on 13) A left atrial appendage occlusion device as in claim 13, wherein the tubular side wall has a thickness of at least about 2 mm. ### Claim 15 (depends on 14) A left atrial appendage occlusion device as in claim 14, wherein the tubular side wall has a void content of at least about 90%. ### Claim 16 (depends on 13) A left atrial appendage occlusion device as in claim 13, wherein the tubular side wall has an average pore size of at least about 100 microns. ### Claim 17 (depends on 13) A left atrial appendage occlusion device as in claim 13, wherein the tubular side wall has an average pore size of at least about 200 microns. ### Claim 18 (depends on 13) A left atrial appendage occlusion device as in claim 13, wherein the tubular side wall is provided with a thromboresistant coating. ### Claim 19 (depends on 13) A left atrial appendage occlusion device as in claim 13, wherein the proximal end wall is provided with a thromboresistant cover. ### Claim 20 (depends on 18) A left atrial appendage occlusion device as in claim 18, wherein the thromboresistant coating comprises PTFE. ### Claim 21 (depends on 13) A left atrial appendage occlusion device as in claim 13, wherein the frame further comprises at least three recapture struts inclining radially inwardly in the proximal direction to a hub. ### Claim 22 (depends on 21) A left atrial appendage occlusion device as in claim 21, wherein the frame comprises a plurality of axially extending side wall struts, with adjacent pairs of side wall struts joined at an apex. ### Claim 23 (depends on 22) A left atrial appendage occlusion device as in claim 22, comprising at least six proximally facing apexes and at least six distally facing apexes. ### Claim 24 (depends on 22) A left atrial appendage occlusion device as in claim 22, wherein each recapture strut is joined to a unique proximally facing apex on the frame. ### Claim 25 (depends on 24) A left atrial appendage occlusion device as in claim 24, wherein the recapture struts are integrally formed with the frame. ### Claim 26 (depends on 21) A left atrial appendage occlusion device as in claim 21, further comprising a lumen through the hub. ### Claim 27 (depends on 13) A left atrial appendage occlusion device as in claim 13, wherein the anchors are flexible anchors configured to extend through the foam side wall at an inclined angle. ### Claim 28 A conformable left atrial appendage (LAA) occlusion device comprising: a compressible tubular foam wall with a closed proximal end, the wall comprising a reticulated, cross linked matrix having at least about 90% void content, an average cell size within the range of from about 250-500 microns, a wall thickness of at least about 2 mm and a compressive strength of at least about 1 psi; and anchors having tips configured to extend radially outwardly and incline proximally through the wall to penetrate tissue of the left atrial appendage. ### Claim 29 (depends on 28) The conformable LAA occlusion device of claim 28, wherein the compressive strength is within a range of from about 1 psi to about 2 psi. ### Claim 30 (depends on 28) The conformable LAA occlusion device of claim 28, further comprising an expandable support configured to compress the wall against a wall of the LAA.