# US 2023/0056089 A1 · Embolisation system for promoting clot formation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2023/0056089 A1 - Document ID: US20230056089A1 - Status: Published application - Kind: A1 - Application number: 17/796,962 - Filed: 2021-02-04 - Published: 2023-02-23 - Earliest claimed: 2020-02-04 - Applicants: Clearstream Technologies Limited - Inventors: Michaella Kavanagh - Web page: https://patentgrep.com/patent/US20230056089A1 ## CPC - 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 17/12031: {complete occlusion} - A61B 17/12109: {in a blood vessel} - A61B 17/12131: {characterised by the type of occluding device} - A61B 17/1214: {Coils or wires} - A61B 17/12177: {comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated} - A61B 2017/00867: {shape memory effect} - A61B 2017/00995: {having a thin film} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract An embolisation device (100) for promoting clot formation in a bodily lumen (170), comprising a stem (110) and a plurality of flexible bristles (120) extending outwardly from the stem, the bristles having a contracted delivery configuration and an expanded deployed configuration in which the bristles extend at least radially outwardly from the stem to anchor the device in the lumen. The embolisation device comprises a flow restrictor configured to restrict flow through the bodily lumen. The flow restrictor comprises: a membrane support (135) having a contracted delivery configuration and an expanded deployed configuration and comprising a self-expanding mesh extending at least radially outwardly from the stem; and an occluding membrane (130) mounted on the membrane support (135). The occlusion rate of the occluding mesh membrane is greater than that of the membrane support. The flow restrictor is attached to the stem at a first longitudinal end, the flow restrictor further comprising an open second longitudinal end. The occluding membrane is configured to restrict flow through the lumen when the device is deployed and the membrane support is in the expanded deployed configuration. ## Claims ### Claim 1 An embolisation device for promoting clot formation in a bodily lumen, comprising a stem and a plurality of flexible bristles extending outwardly from the stem, the bristles having a contracted delivery configuration and an expanded deployed configuration in which the bristles extend at least radially outwardly from the stem to anchor the device in the lumen, wherein the embolisation device further comprises: a flow restrictor configured to restrict flow through the bodily lumen, the flow restrictor comprising: a membrane support having a contracted delivery configuration and an expanded deployed configuration and comprising a self-expanding mesh extending at least radially outwardly from the stem; and an occluding mesh membrane mounted on the membrane support, wherein the occlusion rate of the occluding mesh membrane is greater than that of the membrane support; wherein the flow restrictor is attached to the stem at a first longitudinal end, the flow restrictor further comprising an open second longitudinal end, and wherein the occluding mesh membrane is configured to restrict flow through the lumen when the device is deployed and the membrane support is in the expanded deployed configuration. ### Claim 2 (depends on 1) An embolisation device according to claim 1, wherein the occluding mesh membrane is a metallic mesh membrane, preferably a Nitinol mesh membrane. ### Claim 3 (depends on 1) An embolisation device according to claim 1, wherein the self-expanding mesh is attached to the stem at a first longitudinal end, the self-expanding mesh further comprising a tubular section extending longitudinally along the stem, wherein the tubular section is configured to contact the bodily lumen in the expanded deployed configuration. ### Claim 4 (depends on 1) An embolisation device according to claim 1, wherein the occluding mesh membrane is mounted radially outside of the self-expanding mesh. ### Claim 5 (depends on 1) An embolisation device according to claim 1, wherein the occluding mesh membrane comprises a first network of wires having a first average diameter, and the self-expanding mesh comprises a second network of wires having a second average diameter, wherein the second average diameter is greater than the first average diameter. ### Claim 6 (depends on 1) An embolisation device according to claim 1, wherein the occluding mesh membrane comprises a plurality of pores, and wherein the number of pores per unit area of the occluding mesh membrane is greater than the number of pores per unit area of the self-expanding mesh. ### Claim 7 (depends on 1) An embolisation device according to claim 1, wherein the occluding mesh membrane comprises a plurality of pores having a lateral extent of less than 200 μm, and preferably less than 100 μm. ### Claim 8 (depends on 1) An embolisation device according to claim 1, further comprising a tubular connector receiving the stem and the membrane support to attach the membrane support to the stem. ### Claim 9 (depends on 8) An embolisation device according to claim 8, wherein the occluding mesh membrane is attached to the stem by the tubular connector. ### Claim 10 (depends on 8) An embolisation device according to claim 8, the tubular connector is a crimping connector. ### Claim 11 (depends on 1) An embolisation device according to claim 1, wherein the occluding mesh membrane is attached to the membrane support by adhesive or welding. ### Claim 12 (depends on 1) An embolisation device according to claim 1, wherein the flow restrictor is spaced apart from the plurality of bristles such that in the expanded deployed configuration the flow restrictor is free from contact with any bristles. ### Claim 13 (depends on 12) An embolisation device according to claim 12, wherein the embolisation device is configured to be delivered from a delivery catheter to the bodily lumen in a distal direction, and comprises a bristle segment positioned distally from the flow restrictor. ### Claim 14 (depends on 1) An embolisation device according to claim 1, wherein the embolisation device comprises a bristle segment and the flow restrictor is located longitudinally within the bristle segment or directly adjacent the bristle segment. ### Claim 15 (depends on 14) An embolisation device according to claim 14, wherein the embolisation device is configured to be delivered from a delivery catheter to the bodily lumen in a distal direction, the bristle segment is a proximal bristle segment and the embolisation device further comprises a distal bristle segment spaced apart in the distal direction from the proximal bristle segment. ### Claim 16 A method of manufacturing an embolisation device for promoting clot formation in a bodily lumen, comprising: providing a stem; providing a plurality of flexible bristles extending outwardly from the stem, the bristles having a contracted delivery configuration and an expanded deployed configuration in which the bristles extend at least radially outwardly from the stem to anchor the device in the lumen; providing a membrane support having a contracted delivery configuration and an expanded deployed configuration and comprising a self-expanding mesh; mounting an occluding mesh membrane on the membrane support, the occluding mesh membrane having a greater occlusion rate than that of the membrane support; and attaching the membrane support to the stem such that it extends at least radially outwardly from the stem, the membrane support having a contracted delivery configuration and an expanded deployed configuration in which the radial profile of the membrane support is greater than in the contracted delivery configuration; wherein the membrane support is attached to the stem at a first longitudinal end, the membrane support further comprising an open second longitudinal end, and the occluding mesh membrane is configured to restrict flow through the lumen when the device is deployed and the membrane support is in the expanded deployed configuration. ### Claim 17 (depends on 16) The method of claim 16, wherein the steps of providing the membrane support, mounting the occluding mesh membrane on the membrane support and attaching the membrane support to the stem comprise the steps of: providing a self-expanding tubular mesh; wrapping the occluding mesh membrane around, and attaching it to, the tubular mesh; providing a tubular connector on the stem; inserting an end of the tubular mesh into the tubular connector; and crimping the connector. ### Claim 18 (depends on 17) The method of claim 17, wherein the occluding mesh membrane is wrapped around and attached to the tubular mesh before the tubular mesh is connected to the stem by the crimping connector.