# US 12,178,440 B2 · Micro-macro endovascular occlusion device and methodology > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,178,440 B2 - Document ID: US12178440B2 - Status: Granted - Kind: B2 - Application number: 17/411,788 - Filed: 2021-08-25 - Published: 2021-12-09 - Granted: 2024-12-31 - Earliest claimed: 2017-07-07 - Applicants: John S. DeMeritt - Inventors: John S. DeMeritt - Web page: https://patentgrep.com/patent/US12178440B2 ## CPC - A61B 17/12145: {having a pre-set deployed three-dimensional shape (methods of manufacturing A61B2017/00526)} - 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 17/12109: {in a blood vessel} - A61B 17/12113: {within an aneurysm} - A61B 17/12122: {within the heart (for closing a cardiac septal defect A61B17/0057)} - A61B 17/1214: {Coils or wires} - 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 17/12036: {partial occlusion} - A61B 2017/00292: {mounted on or guided by flexible, e.g. catheter-like, means} - A61B 2017/00592: {Elastic or resilient implements} - A61B 2017/00632: {Occluding a cavity, i.e. closing a blind opening} - A61B 2017/00778: {Operations on blood vessels (A61B2017/22097, A61B2017/320741 take precedence)} - A61B 2017/00867: {shape memory effect} - A61B 2017/1205: {Introduction devices} - A61B 2017/12054: {Details concerning the detachment of the occluding device from the introduction device} - A61B 2017/12127: {Double occlusion, e.g. for creating blood-free anastomosis site} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A vascular plug comprises a superstructure expandable from a collapsed percutaneous insertion configuration to an expanded deployment or use configuration. The superstructure is comprised of both primary and secondary three-dimensional shapes allowing for the occlusion of a wide range of vessel sizes from small to large through a disproportionately small delivery catheter. The plug includes a shape memory element for the generation of radial force and the creation of the larger secondary three-dimensional twisting or helical superstructure as is needed for target vessel occlusion. ## Claims ### Claim 1 A medical device comprising a superstructure expandable from a collapsed insertion configuration to a fully expanded deployment or use configuration, said insertion configuration being sufficiently small to enable percutaneous introduction, said fully expanded deployment or use configuration being sufficiently large to extend across a target cavity in organic tissues of a patient and engage an inner surface of such cavity, said insertion configuration of said superstructure taking the form of a collapsed self-expanding tubular structure expandable to said fully expanded deployment or use configuration, said fully expanded deployment or use configuration being a three-dimensional twisted or helical form of said tubular structure, said twisted or helical form of said tubular structure having a plurality of turns or windings of respective outer diameters, said plurality of turns or windings including at least one terminal turn or winding at at least one of two opposite ends of said twisted or helical form of said tubular structure and further including at least one center turn or winding intermediate said two opposite ends, said at least one center turn or winding having an outer diameter that is larger than a largest outer diameter of said at least one terminal turn or winding, said fully expanded deployment or use configuration having an arcuate envelope or shape that tapers down at said at least one of said two opposite ends from said at least one center turn or winding. ### Claim 2 (depends on 1) The medical device defined in claim 1 wherein said superstructure includes an outer wall of said tubular structure and an inner wire made of shape memory material, said inner wire being operatively connected to said tubular structure to form said tubular structure into said twisted or helical form. ### Claim 3 (depends on 2) The medical device defined in claim 2 wherein said inner wire is connected to said tubular structure at one or more points along a length of said outer wall. ### Claim 4 (depends on 2) The medical device defined in claim 2 wherein said inner wire is a coiling shaping wire incorporated into or interwoven with said outer wall. ### Claim 5 (depends on 2) The medical device defined in claim 2 wherein said inner wire is a coiling shaping wire freely disposed in a lumen of said outer wall. ### Claim 6 (depends on 2) The medical device defined in claim 2 wherein said inner wire is a coiling shaping wire partially attached to a portion of said outer wall. ### Claim 7 (depends on 1) A kit or assembly comprising the medical device defined in claim 1 and further comprising an expandable plug configured for intertwining or interlocking with the medical device of claim 1, the medical device and the expandable plug being deployable in cooperation with one another for large vessel occlusion and catheter delivery. ### Claim 8 (depends on 1) The medical device defined in claim 1 wherein the outer diameter of said at least one center turn or winding of said fully expanded use or deployment configuration is sufficiently large to extend across and occlude largest vessels of a human cardiovascular system. ### Claim 9 (depends on 1) The medical device defined in claim 1 wherein said tubular structure is at least partially covered or enveloped by a membrane. ### Claim 10 (depends on 9) The medical device defined in claim 9 wherein said membrane is made of flow-impervious material. ### Claim 11 (depends on 9) The medical device defined in claim 9 wherein at least a downstream or trailing portion of said membrane is made of a porous material. ### Claim 12 (depends on 1) The medical device defined in claim 1 wherein said tubular structure is at least partially coated with a thrombogenic material, so that the device on implantation or deployment in a blood vessel results in a gradual vessel thrombosis, reducing chances of flow-related device migration. ### Claim 13 (depends on 12) The medical device defined in claim 12 wherein said thrombogenic material is taken from the group consisting of small fibers and hydrogel. ### Claim 14 (depends on 1) The medical device defined in claim 1 wherein said tubular structure has a cross section and associated outer diameter that taper down from said at least one center turn or winding towards said at least one of said two opposite ends. ### Claim 15 (depends on 14) The medical device defined in claim 14 wherein said cross section and associated outer diameter of said tubular structure taper down to terminal points at each of said opposite ends. ### Claim 16 (depends on 1) The medical device defined in claim 1 wherein said twisted or helical structure subtends a central channel, said central channel being closed off at least at said one of said two opposite ends owing to tapering down of the outer diameters of said turns or windings of said tubular structure along with simultaneous tapering or outer diameter reduction of said tubular structure at said at least one of said two opposite ends. ### Claim 17 (depends on 1) The medical device defined in claim 1 wherein said plurality of turns or windings includes at least one terminal turn or winding at each of said two opposite ends of said twisted or helical form of said tubular structure, said twisted or helical form of said tubular structure having an envelope or overall shape that is ellipsoidal or ovoid. ### Claim 18 (depends on 1) The medical device defined in claim 1 wherein said plurality of turns or windings includes at least one terminal turn or winding at each of said two opposite ends of said twisted or helical form of said tubular structure, said twisted or helical form of said tubular structure having an envelope or overall shape that is conical on one or both ends. ### Claim 19 A medical method comprising: providing two medical occlusion devices each having a superstructure with a fully expanded form that includes a tubular structure; inserting, into a vascular system of a patient, a first one of said medical occlusion devices with the respective said superstructure in a collapsed configuration; thereafter expanding the superstructure of said first one of said medical occlusion devices from the collapsed configuration to an adaptively expanded configuration inside a cavity in the patient so that the expanded superstructure of said first one of said medical occlusion devices extends across a selected portion of said cavity and engages an inner surface of said cavity, wherein the adaptively expanded configuration of said first one of said medical occlusion devices has an opening; inserting, into the patient, a second one of said medical occlusion devices with the respective said superstructure in a collapsed configuration; thereafter expanding the superstructure of said second one of said medical occlusion devices from the respective collapsed configuration to an expanded configuration inside a target blood vessel with an end portion of said second one of said medial occlusion devices inserted into said opening in the expanded superstructure of said first one of said medical occlusion devices so that the expanded superstructure of said second one of said medical occlusion devices occludes said opening in the expanded superstructure of said first one of said medical occlusion devices.