Systems and methods for making and using a lead introducer with a seal for an electrical stimulation system

• US 10,226,616 B2
• Filed: 04/26/2016
• Issued: 03/12/2019
• Est. Priority Date: 04/28/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Barker, John M.
• Primary Examiner(s): Nguyen, Tuan V
• Application Number:
  US15/139,149
• Publication Number:
  US 20160317800A1
• Time in Patent Office: 1,050 Days
• CPC Class Codes: 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
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

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

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 an open channel extending along a longitudinal length of the outer needle body, and

an inner needle comprising an inner needle body configured and arranged for sliding along the open channel of the outer needle 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 and arranged for disposing over the outer needle body and the inner needle body and for being longitudinally splittable, wherein the splittable member hub comprises an interior surface and is configured and arranged to receive at least one or more portions of both the inner needle hub and the outer needle hub within the splittable member hub; and

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 and arranged to form a fluid-resisting seal with the interior surface of the splittable member hub when the at least one or more portions of the inner needle hub and outer needle hub are received within the splittable member hub.

2. The lead introducer of claim 1, wherein the splittable member comprises a radiopaque marker disposed at or near the distal end of the splittable member.

3. The lead introducer of claim 1, wherein the annular seal member comprises an O-ring disposed along a distal portion of the inner needle hub.

4. The lead introducer of claim 1, wherein the outer needle hub defines an annular detent and the splittable member huh comprises a ridged structure configured and arranged to mate with the annular detent.

5. The lead introducer of claim 1, 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.

6. The lead introducer of claim 5, 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.

7. The lead introducer of claim 5, wherein the outer needle hub defines a wedge-shaped opening configured and arranged to mate with the wedge of the seal element of the inner needle hub.

8. The lead introducer of claim 5, wherein the seal element of the inner needle hub has a conical shape except for the wedge.

9. An insertion kit comprising:

the lead introducer of claim 1; and

a neurostimulation lead configured and arranged 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 plurality of electrodes electrically to the plurality of terminals;

wherein the open channel of the outer needle body is configured and arranged such that, when the inner needle of the lead introducer is not inserted in the open channel, the distal end portion of the lead body is insertable into the open channel with the lead body being laterally separatable from the outer needle of the lead introducer through the open channel of the outer needle body.

10. An electrical stimulation system comprising:

the insertion kit of claim 9;

a control module configured and arranged 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 and arranged to couple to the plurality of terminals of the neurostimulation lead when the proximal end portion of the neurostimulation lead is received by the connector housing.

19. 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 open 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 the length of the lumen 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.

11. 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 an open channel extending along a longitudinal length of the outer needle body, and

an inner needle comprising an inner needle body configured and arranged for sliding along the open channel of the outer needle 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 and arranged for disposing over the outer needle body and the inner needle body, wherein the splittable member hub comprises an interior surface and is configured and arranged to receive at least portions of both the inner needle hub and the outer needle hub within the splittable member hub, wherein the splittable member hub comprises two pull-apart tabs extending proximally from the splittable member body in a direction parallel to the longitudinal axis of the splittable member, wherein the splittable member is configured for separating longitudinally by pulling the two pull-apart tabs away from each other.

12. The lead introducer of claim 11, wherein the inner needle hub comprises a collar defining two openings, wherein the two openings are configured and arranged to receive a portion of the two pull-apart tabs within the two openings to prevent inadvertently pulling the two pull-apart tabs away from each other.

13. The lead introducer of claim 11, wherein the outer needle hub comprises a collar defining two openings, wherein the two openings are configured and arranged to receive a portion of the two pull-apart tabs within the two openings to prevent inadvertently pulling the two pull-apart tabs away from each other.

14. The lead introducer of claim 11, further comprising a stylet comprising a stylet body and a stylet hub coupled to the stylet body, wherein the stylet body is configured and arranged for sliding along the lumen of the inner needle body and the stylet huh comprises projections disposed on a distal portion of the stylet hub and defining cavities to receive a portion of the two pull apart tabs.

15. The lead introducer of claim 11, 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 huh, wherein the annular seal member is configured and arranged to form 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.

16. The lead introducer of claim 11, wherein the splittable member comprises a radiopaque marker disposed at or near the distal end of the splittable member.

17. An insertion kit comprising:

the lead introducer of claim 11; and

a neurostimulation lead configured and arranged 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 plurality of electrodes electrically to the plurality of terminals;

wherein the open channel of the outer needle body is configured and arranged such that, when the inner needle of the lead introducer is not inserted in the open channel, the distal end portion of the lead body is insertable into the open channel with the lead body being laterally separatable from the outer needle of the lead introducer through the open channel of the outer needle body.

18. An electrical stimulation system comprising:

the insertion kit of claim 17;

a control module configured and arranged 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 and arranged to couple to the plurality of terminals of the neurostimulation lead when the proximal end portion of the neurostimulation lead is received by the connector housing.

20. A method for implanting a neurostimulation lead into a patient, the method comprising:

advancing the lead introducer of claim 11 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 open 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 the length of the lumen 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.