# US 11,896,820 B2 · Apparatus and method for positioning, implanting and using a stimulation lead > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,896,820 B2 - Document ID: US11896820B2 - Status: Granted - Kind: B2 - Application number: 17/875,744 - Filed: 2022-07-28 - Published: 2022-11-17 - Granted: 2024-02-13 - Earliest claimed: 2015-10-15 - Assignees: Spr Therapeutics, Inc. - Applicants: SPR Therapeutics, Inc. - Inventors: Joseph W. Boggs, II; Amorn Wongsarnpigoon; Matthew G. deBock; Meredith J. McGee; Devin Sell; Robert B Strother, Jr. - Web page: https://patentgrep.com/patent/US11896820B2 ## CPC - A61N 1/0558: {Anchoring or fixation means therefor} - A61B 17/3403: {Needle locating or guiding means} - A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)} - A61N 1/0502: {Skin piercing electrodes} - A61N 1/36017: {with leads or electrodes penetrating the skin} - A61N 1/37205: {Microstimulators, e.g. implantable through a cannula} - A61N 1/37241: {providing test stimulations} - A61B 2017/3407: {including a base for support on the body} - A61B 2017/3413: {guided by ultrasound} - 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) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract An introducing device for locating a tissue region and deploying an electrode is shown and described. The introducing device may include an outer sheath. An inner sheath may be disposed within the outer sheath. The inner sheath may be configured to engage an implantable electrode. In an example, the inner sheath may comprise a stimulation probe having an uninsulated portion at or near a distal end of the delivery sheath. The outer sheath may be coupled to a power source or stimulation signal generating circuitry at a proximal end. A clinician may control application of the stimulation signal to a tissue region via the outer sheath. ## Claims ### Claim 1 An introducer system comprising: an electrical stimulus generator; an open-coiled stimulation lead having a conductive distal anchor, a proximal end in communication with the electrical stimulus generator and a centrally disposed axial void; a needle assembly comprising a first needle comprising an outer sheath having an outer circumference and defining a bore wherein the outer circumference is not continuous, a second needle carried within the bore during positioning and testing of the open-coiled stimulation lead, and at least one test electrode positioned along the outer circumference and in electrical communication with the electrical stimulus generator; and a third needle comprising a third needle sheath having a third needle outer circumference and defining a third needle bore wherein the open-coiled stimulation lead is carried within the third needle sheath, whereby the open-coiled stimulation lead and the third needle sheath replace the second needle in preparation for deployment of the open-coiled stimulation lead. ### Claim 2 (depends on 1) The introducer system of claim 1, wherein upon activation of a test mode of the electrical stimulus generator, the at least one test electrode delivers test stimulation at one or more desired positions. ### Claim 3 (depends on 2) The introducer system of claim 2, wherein the needle assembly is repeatedly repositionable to test stimulation without requiring the open-coiled stimulation lead and the third needle sheath to be utilized. ### Claim 4 (depends on 3) The introducer system of claim 3, wherein as the open-coiled stimulation lead is deployed from the needle assembly, the distal anchor is anchored at a desired position. ### Claim 5 (depends on 1) The introducer system according to claim 1, wherein the first needle comprises a slot along a length of the first needle to form the non-continuous outer circumference. ### Claim 6 (depends on 5) The introducer system according to claim 5, wherein the slot has width to allow the distal anchor of the open-coiled stimulation lead to pass through unimpeded. ### Claim 7 (depends on 6) The introducer system according to claim 6, wherein the third needle sheath can pass within the outer sheath once the second needle is removed. ### Claim 8 (depends on 7) The introducer system according to claim 7, wherein the third needle sheath incorporates one or more flanges or protrusions running a length of the third needle sheath. ### Claim 9 (depends on 8) The introducer system according to claim 8, wherein the one or more flanges or protrusions fit within a space defined by the slot and orient the third needle and the anchor with respect to the slot. ### Claim 10 (depends on 1) The introducer system according to claim 1, wherein the second needle incorporates one or more second needle flanges or protrusions running a length of the second needle. ### Claim 11 (depends on 10) The introducer system according to claim 10, wherein the one or more second needle flanges or protrusions fit within a space defined by a slot. ### Claim 12 (depends on 1) The introducer system according to claim 1, wherein the second needle comprises a solid, non-coring shaft which is free of an opening or bore. ### Claim 13 (depends on 1) The introducer system according to claim 1, wherein the second needle comprises a plurality of test electrodes positioned along its length. ### Claim 14 (depends on 13) The introducer system according to claim 13, wherein the open-coiled stimulation lead is deployable at any location corresponding with a location previously occupied by at least one of the test electrodes of the second needle. ### Claim 15 An introducer system comprising: an electrical stimulus generator; an open-coiled stimulation lead having a conductive distal anchor, a proximal end in communication with the electrical stimulus generator and a centrally disposed axial void; a needle assembly comprising a first needle comprising an outer sheath having an outer circumference and defining a bore wherein the outer circumference is not continuous, a second needle carried within the bore during positioning and testing of the open-coiled stimulation lead, and at least one test electrode positioned along the outer circumference and in electrical communication with the electrical stimulus generator; and a third needle comprising a third needle sheath having a third needle outer circumference and defining a third needle bore wherein the open-coiled stimulation lead is carried within the third needle sheath, whereby the open-coiled stimulation lead and the third needle sheath replace the second needle in preparation for deployment of the open-coiled stimulation lead, wherein the needle assembly is repeatedly repositionable to test stimulation without requiring the open-coiled stimulation lead and the third needle sheath to be utilized. ### Claim 16 (depends on 15) The introducer system according to claim 15, wherein the second needle comprises a plurality of test electrodes positioned along its length. ### Claim 17 (depends on 16) The introducer system according to claim 16, wherein the open-coiled stimulation lead is deployable at any location corresponding with a location previously occupied by at least one of the test electrodes of the second needle. ### Claim 18 An introducer system comprising: an electrical stimulus generator; an open-coiled stimulation lead having a conductive distal anchor, a proximal end in communication with the electrical stimulus generator and a centrally disposed axial void; a needle assembly comprising a first needle comprising an outer sheath defining a bore, a second needle carried within the bore during positioning and testing of the open-coiled stimulation lead, wherein the second needle incorporates one or more second needle flanges or protrusions running a length of the second needle and at least one test electrode in electrical communication with the electrical stimulus generator; and a third needle comprising a third needle sheath having a third needle outer circumference and defining a third needle bore wherein the open-coiled stimulation lead is carried within the third needle sheath, whereby the open-coiled stimulation lead and the third needle sheath replace the second needle in preparation for deployment of the open-coiled stimulation lead. ### Claim 19 (depends on 18) The introducer system according to claim 18, wherein the second needle comprises a plurality of test electrodes positioned along its length. ### Claim 20 (depends on 19) The introducer system according to claim 19, wherein the open-coiled stimulation lead is deployable at any location corresponding with a location previously occupied by at least one of the test electrodes of the second needle.