# US 10,946,186 B2 · Systems and methods for making and using a lead introducer with a seal for an electrical stimulation system > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,946,186 B2 - Document ID: US10946186B2 - Status: Granted - Kind: B2 - Application number: 16/246,355 - Filed: 2019-01-11 - Published: 2019-05-16 - Granted: 2021-03-16 - Earliest claimed: 2015-04-28 - Assignees: Boston Scientific Neuromodulation Corporation - Applicants: Boston Scientific Neuromodulation Corporation - Inventors: John M. Barker - Web page: https://patentgrep.com/patent/US10946186B2 ## CPC - A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence) - A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)} - A61B 17/3417: {Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating (syringe needles A61M5/32; dilators A61M29/00)} - A61B 2090/3966: {Radiopaque markers visible in an X-ray image} - A61M 25/0668: {splittable, tear apart} - A61N 1/0551: {Spinal or peripheral nerve electrodes} - 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) - 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)} ## Abstract One embodiment is a lead introducer including an outer needle, an inner needle, a splittable member, and an annular seal member. The outer needle, inner needle, and splittable member each include a body and hub. The splittable member fits over the outer needle body and the inner needle body and can be separated longitudinally. The splittable member hub receives at least portions of both the inner needle hub and the outer needle hub within the splittable member hub. The annular seal member is formed by either a) the inner needle hub or b) a combination of the inner needle hub and outer needle hub. The annular seal member forms a fluid-resisting seal with the interior surface of the splittable member hub when the portions of the inner needle hub and outer needle hub are received within the splittable member hub. ## Claims ### Claim 1 A lead introducer comprising: an outer needle comprising an outer needle body and an outer needle hub coupled to the outer needle body, the outer needle body defining a channel extending along a longitudinal length of the outer needle body, and an inner needle comprising an inner needle body configured for sliding along the channel of the outer needle body and an inner needle hub coupled to the inner needle body, the inner needle body defining a lumen extending along a longitudinal length of the inner needle body; and a splittable member comprising a splittable member body and a splittable member hub and having a distal end, the splittable member defining a longitudinal axis and configured for disposing over the outer needle body, wherein the splittable member hub comprises a splittable hub body and two pull-apart tabs, wherein the splittable hub body comprises a transverse proximal face defining an opening and the two pull-apart tabs extend in a proximal direction from the transverse proximal face of the splittable hub body, wherein the splittable member is configured for separating longitudinally by pulling the two pull-apart tabs away from each other. ### Claim 2 (depends on 1) The lead introducer of claim 1, wherein the two pull-apart tabs extend parallel to the longitudinal axis of the splittable member. ### Claim 3 (depends on 1) The lead introducer of claim 1, wherein the inner needle hub comprises a collar defining one or more openings, wherein the one or more openings are configured to receive a portion of the two pull-apart tabs within the one or more openings to prevent inadvertently pulling the two pull-apart tabs away from each other. ### Claim 4 (depends on 1) The lead introducer of claim 1, wherein the outer needle hub comprises a collar defining one or more openings, wherein the one or more openings are configured to receive a portion of the two pull-apart tabs within the one or more openings to prevent inadvertently pulling the two pull-apart tabs away from each other. ### Claim 5 (depends on 1) The lead introducer of claim 1, further comprising a stylet configured for sliding along the lumen of the inner needle body. ### Claim 6 (depends on 5) The lead introducer of claim 5, wherein the stylet comprises a stylet hub with projections disposed on a distal portion of the stylet hub and defining one or more cavities to receive a portion of the two pull apart tabs. ### Claim 7 (depends on 1) The lead introducer of claim 1, wherein the splittable member hub is configured to receive at least portions of both the inner needle hub and the outer needle hub within the splittable member hub. ### Claim 8 (depends on 7) The lead introducer of claim 7, further comprising an annular seal member formed by either a) the inner needle hub or b) a combination of the inner needle hub and outer needle hub, wherein the annular seal member is configured to form a fluid-resisting seal with an interior surface of the splittable member hub when portions of the inner needle hub and outer needle hub are received within the splittable member hub. ### Claim 9 (depends on 1) An insertion kit comprising: the lead introducer of claim 1; and a neurostimulation lead configured for implantation into a patient, the neurostimulation lead comprising a lead body having a distal end portion and a proximal end portion, a plurality of electrodes disposed at the distal end portion of the lead body, a plurality of terminals disposed at the proximal end portion of the lead body, and a plurality of conductive wires coupling the electrodes electrically to the terminals; wherein the channel of the outer needle body is configured such that, when the inner needle of the lead introducer is not inserted in the channel, the distal end portion of the lead body is insertable into the channel with the lead body being laterally separatable from the outer needle of the lead introducer through the channel of the outer needle body. ### Claim 10 (depends on 9) An electrical stimulation system comprising: the insertion kit of claim 9; a control module configured to electrically couple to the neurostimulation lead of the insertion kit, the control module comprising a housing, and an electronic subassembly disposed in the housing; and a connector for receiving the neurostimulation lead, the connector comprising a connector housing defining a port for receiving the proximal end portion of the lead body, and a plurality of connector contacts disposed in the connector housing, the connector contacts configured to couple to the terminals of the neurostimulation lead when the proximal end portion of the lead body of the neurostimulation lead is received by the connector housing. ### Claim 11 (depends on 1) A method for implanting a neurostimulation lead into a patient, the method comprising: advancing the lead introducer of claim 1 into the patient; removing the inner needle of the lead introducer from the patient, leaving the outer needle and splittable member of the lead introducer within the patient; inserting into the channel of the outer needle body a distal end portion of a neurostimulation lead, the neurostimulation lead comprising a plurality of electrodes disposed along a distal end portion of the neurostimulation lead and a plurality of terminals disposed along a proximal end portion of the neurostimulation lead; separating the splittable member into at least two parts along a length of the splittable member; and removing the outer needle and the splittable member from the patient, leaving the neurostimulation lead implanted in the patient at a target stimulation location. ### Claim 12 A lead introducer comprising: an outer needle comprising an outer needle body and an outer needle hub coupled to the outer needle body, the outer needle body defining a channel extending along a longitudinal length of the outer needle body, and an inner needle comprising an inner needle body configured for sliding along the channel of the outer needle body and an inner needle hub coupled to the inner needle body, the inner needle body defining a lumen extending along a longitudinal length of the inner needle body; a splittable member comprising a splittable member body and a splittable member hub and having a distal end, the splittable member configured for disposing over the outer needle body and for being longitudinally splittable, wherein the splittable member hub is configured to receive at least a portion of the inner needle hub within the splittable member hub; and an annular seal member formed by the inner needle hub, wherein the annular seal member is configured to form a fluid-resisting seal with the splittable member hub when the portion of the inner needle hub is received within the splittable member hub. ### Claim 13 (depends on 12) The lead introducer of claim 12, wherein the annular seal member comprises an O-ring disposed along a distal portion of the inner needle hub. ### Claim 14 (depends on 12) A method for implanting a neurostimulation lead into a patient, the method comprising: advancing the lead introducer of claim 12 into the patient; removing the inner needle of the lead introducer from the patient, leaving the outer needle and splittable member of the lead introducer within the patient; inserting into the channel of the outer needle body a distal end portion of a neurostimulation lead, the neurostimulation lead comprising a plurality of electrodes disposed along a distal end portion of the neurostimulation lead and a plurality of terminals disposed along a proximal end portion of the neurostimulation lead; separating the splittable member into at least two parts along a length of the splittable member; and removing the outer needle and the splittable member from the patient, leaving the neurostimulation lead implanted in the patient at a target stimulation location. ### Claim 15 A lead introducer comprising: an outer needle comprising an outer needle body and an outer needle hub coupled to the outer needle body, the outer needle body defining a channel extending along a longitudinal length of the outer needle body, and an inner needle comprising an inner needle body configured for sliding along the channel of the outer needle body and an inner needle hub coupled to the inner needle body, the inner needle body defining a lumen extending along a longitudinal length of the inner needle body; a splittable member comprising a splittable member body and a splittable member hub and having a distal end, the splittable member configured for disposing over the outer needle body and the inner needle body and for being longitudinally splittable, wherein the splittable member hub is configured to receive at least a portion of both the inner needle hub and the outer needle hub within the splittable member hub; and an annular seal member formed by a combination of the inner needle hub and the outer needle hub, wherein the annular seal member is configured to form a fluid-resisting seal with the splittable member hub when the portions of the inner needle hub and outer needle hub are received within the splittable member hub. ### Claim 16 (depends on 15) The lead introducer of claim 15, wherein the annular seal member comprises an O-ring disposed along a distal portion of the inner needle hub and an annular detent defined by the outer needle hub, wherein the splittable member hub comprises a ridged structure configured to mate with the annular detent. ### Claim 17 (depends on 15) The lead introducer of claim 15, wherein the inner needle hub comprises a seal element comprising a wedge and a partial seal rib defined at a distal end of the wedge. ### Claim 18 (depends on 17) The lead introducer of claim 17, wherein the outer needle hub further comprises a seal rib that, when mated with the partial seal rib of the inner needle hub, forms the annular seal member. ### Claim 19 (depends on 17) The lead introducer of claim 17, wherein the outer needle hub defines a wedge-shaped opening configured to mate with the wedge of the seal element of the inner needle hub. ### Claim 20 (depends on 17) The lead introducer of claim 17, wherein the seal element of the inner needle hub has a conical shape except for the wedge.