# US 10,478,619 B2 · Implantable lead affixation structure for nerve stimulation to alleviate bladder dysfunction and other indication > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,478,619 B2 - Document ID: US10478619B2 - Status: Granted - Kind: B2 - Application number: 15/719,487 - Filed: 2017-09-28 - Published: 2018-03-22 - Granted: 2019-11-19 - Earliest claimed: 2014-08-15 - Assignees: Axonics Modulation Technologies, Inc. - Applicants: Axonics Modulation Technologies, Inc. - Inventors: Henry Lee; Alexander Hwu - Web page: https://patentgrep.com/patent/US10478619B2 ## CPC - A61N 1/0558: {Anchoring or fixation means therefor} - A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control} - A61N 1/36062: {Spinal stimulation} - B23K 26/242: Fillet welding, i.e. involving a weld of substantially triangular cross section joining two parts - B23K 26/38: by boring or cutting - B23K 26/40: taking account of the properties of the material involved - B29C 45/14065: {Positioning or centering articles in the mould} - B29C 45/14598: {Coating tubular articles} - B23K 2103/14: Titanium or alloys thereof - B23K 2103/18: Dissimilar materials - B23K 2103/26: {Alloys of Nickel and Cobalt and Chromium} - B29C 45/14778: {the article consisting of a material with particular properties, e.g. porous, brittle} - B29L 2031/753: {Medical equipment; Accessories therefor (bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008)} - 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) - B23K: SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM - B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00) - B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES ## Abstract Anchoring devices and methods for affixing an implanted lead of a neurostimulation system at a target location in a patient are provided herein. Such anchoring devices includes a helical body having a plurality of tines extending laterally outward from the lead when deployed that engage tissue to inhibit axial movement of the implanted lead. The plurality of tines are biased towards the laterally extended deployed configuration and fold inward towards the lead to a delivery configuration to facilitate delivery of the lead through a sheath. The tines may be angled in a proximal direction or in both proximal and distal directions and may include various features to assist in visualization and delivery of the lead. The anchor may be formed according to various methods, including laser cutting of a tubular section along with heat or reflow to set the material with the anchor in the deployed configuration and injection molding. ## Claims ### Claim 1 A method of forming a neurostimulation lead anchor for anchoring an implanted neurostimulation lead at a target tissue location in a body of a patient, the method comprising: laser cutting a helical pattern into a single tubular section of a material, the helical pattern corresponding to a neurostimulation lead anchor with a helical body having a plurality of tines in a constrained configuration; supporting the plurality of tines of the single tubular section in an outwardly protruding position corresponding to a deployed configuration of the neurostimulation lead anchor; and heat setting the single tubular section while the plurality of tines are supported, thereby setting the material while the neurostimulation lead anchor is in the deployed configuration. ### Claim 2 (depends on 1) The method of claim 1, wherein the material is a shape-memory metal alloy such that the shape-memory metal alloy resiliently returns to the deployed configuration upon heating in the body after implantation. ### Claim 3 (depends on 1) The method of claim 1, wherein the material is a polymer-based material that is set by reflow and that remains sufficiently flexible when set so that the plurality of tines can fold inward against a lead when constrained within a sheath to facilitate implantation of the neurostimulation lead anchor when affixed on the lead. ### Claim 4 (depends on 1) The method of claim 1 further comprising: affixing the neurostimulation lead anchor to an anchoring portion of a neurostimulation lead by wrapping the helical body about the anchoring portion of the neurostimulation lead. ### Claim 5 (depends on 1) The method of claim 1, wherein the neurostimulation lead anchor is dimensioned such that, when attached to a lead body and in the constrained configuration, the neurostimulation lead anchor has a cross sectional profile sufficiently small to facilitate delivery through a 5 French sheath. ### Claim 6 (depends on 1) The method of claim 1, wherein the material has sufficient stiffness so that, when attached to an implanted lead and in the deployed configuration, engagement of tissue with the plurality of tines inhibits axial movement of the implanted lead when implanted in the tissue at a target location. ### Claim 7 (depends on 6) The method of claim 6, wherein the material comprises a polyurethane based material having a shore hardness in a range between 50A and 80D. ### Claim 8 (depends on 6) The method of claim 6, wherein the material comprises a metal. ### Claim 9 (depends on 1) The method of claim 1, further comprising: affixing the neurostimulation lead anchor to an anchoring portion of a neurostimulation lead. ### Claim 10 (depends on 9) The method of claim 9, wherein the neurostimulation lead has one or more neurostimulation electrodes distal of the anchoring portion. ### Claim 11 (depends on 10) The method of claim 10, wherein the neurostimulation lead comprises a sacral neuromodulation lead configured for advancing through a sacral foramen until the one or more neurostimulation electrodes are positioned at a sacral nerve. ### Claim 12 (depends on 9) The method of claim 9, wherein the anchoring portion of the neurostimulation lead has a reduced profile so as to reduce a cross-section thereof along the neurostimulation lead anchor. ### Claim 13 (depends on 12) The method of claim 12, wherein the reduced profile is about 2 mm or less. ### Claim 14 (depends on 9) The method of claim 9, wherein the helical body is heat set to a smaller inside diameter than a diameter of the neurostimulation lead so as to provide an interference fit on the neurostimulation lead. ### Claim 15 A method of forming a neurostimulation lead anchor for anchoring an implanted neurostimulation lead at a target tissue location in a body of a patient, the method comprising: cutting a pattern into a single tubular portion of a material, the pattern corresponding to a neurostimulation lead anchor comprising a plurality of tines in a constrained configuration, wherein the plurality of tines are distributed along a longitudinal axis of the neurostimulation lead anchor; supporting the plurality of tines in an outwardly protruding position corresponding to a deployed configuration of the anchor; and setting the plurality of tines in the outwardly protruding position by heat setting or reflow. ### Claim 16 (depends on 15) The method of claim 15, wherein the material is a shape-memory metal alloy such that the shape-memory metal alloy resiliently returns to the deployed configuration upon heating in the body after implantation. ### Claim 17 (depends on 15) The method of claim 15, wherein the material is a polymer-based material that is set by reflow and that remains sufficiently flexible when set so that the plurality of tines can fold inward against a lead when constrained within a sheath to facilitate implantation of the neurostimulation lead anchor when affixed on the lead. ### Claim 18 (depends on 15) The method of claim 15 further comprising: affixing the neurostimulation lead anchor to an anchoring portion of a neurostimulation lead. ### Claim 19 (depends on 18) The method of claim 18, wherein the neurostimulation lead anchor is dimensioned such that, when attached to the neurostimulation lead in the constrained configuration, the neurostimulation lead anchor has a cross sectional profile sufficiently small to facilitate delivery through a 5 French sheath. ### Claim 20 (depends on 18) The method of claim 18, wherein the neurostimulation lead comprises one or more neurostimulation electrodes, and wherein the neurostimulation lead comprises a sacral neuromodulation lead configured for advancing through a sacral foramen until the one or more neurostimulation electrodes are positioned at a sacral nerve.