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

• US 9,629,658 B2
• Filed: 09/02/2014
• Issued: 04/25/2017
• Est. Priority Date: 09/06/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Barker, John Michael
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US14/475,373
• Publication Number:
  US 20150073431A1
• Time in Patent Office: 966 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: A61M 25/06 Body-piercing guide needles or the like
• 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

A lead introducer includes an outer needle with a sharpened distal tip and an open channel extending along an entire length of the outer needle. An inner needle slides along the open channel of the outer needle. The inner needle includes a blunt distal tip. A biasing element is coupled to the inner needle and facilitates transition of the inner-needle distal tip between a distally-biased position, where the inner-needle distal tip obstructs the sharpened outer-needle distal tip, and a retracted position, where the inner-needle distal tip exposes the sharpened outer-needle distal tip. A splittable member is disposable over the outer needle when the inner needle is disposed in the open channel of the outer needle. The splittable member is separatable from the inner and outer needles along at least one perforated region.

Claims

1. A lead introducer comprising:

an outer needle comprising

an outer-needle body having a proximal end portion, a distal end portion, and a longitudinal length,

a sharpened distal tip disposed along the distal end portion of the outer-needle body, and

an open channel extending along the entire longitudinal length of the outer-needle body;

an inner needle configured and arranged for sliding along the open channel of the outer needle, the inner needle comprising

an inner-needle body having a proximal end portion, a distal end portion, and a longitudinal length,

a blunt distal tip disposed along the distal end portion of the inner-needle body, and

an inner-needle proximal hub attached to the proximal end portion of the inner-needle body;

a biasing element coupled to the inner-needle body, the biasing element configured and arranged to facilitate a transition of the distal tip of the inner needle between a distally-biased position, where the distal tip of the inner needle obstructs the sharpened distal tip of the outer needle, and a retracted position, where the distal tip of the inner needle at least partially exposes the distal tip of the outer needle; and

a splittable member having at least one perforated region extending along a longitudinal length of the splittable member, the splittable member configured and arranged for disposing over the outer-needle body and the inner-needle body when the inner-needle body is disposed in the open channel of the outer-needle body and for separating from the outer-needle body and the inner-needle body by separating along the at least one perforated region.

2. The lead introducer of claim 1, wherein the biasing element is disposed in the inner-needle proximal hub.

3. The lead introducer of claim 1, wherein the inner-needle proximal hub comprises:

a first portion defining a cavity for receiving the biasing element; and

a second portion partially disposed in the cavity of the first portion of the inner-needle proximal hub.

4. The lead introducer of claim 3, wherein the outer needle comprises an outer-needle proximal hub attached to the proximal end portion of the outer-needle body, the outer-needle proximal hub defining a recess along a distal end of the outer-needle proximal hub.

5. The lead introducer of claim 4, wherein the second portion of the inner-needle proximal hub is partially disposed within the recess while concurrently being partially disposed in the cavity of the first portion of the inner-needle proximal hub when the inner-needle body is disposed in the open channel of the outer needle.

6. The lead introducer of claim 3, wherein the inner-needle proximal hub further comprises a watertight seal disposed between the first portion and the second portion of the inner-needle proximal hub.

7. The lead introducer of claim 6, wherein the watertight seal is disposed in an annular groove defined along an outer surface of the second portion of the inner-needle hub.

8. The lead introducer of claim 1, wherein the inner-needle proximal hub further comprises a lock pin for limiting travel of the biasing element when the biasing element is transitioned to a compressed position.

9. The lead introducer of claim 1, wherein the biasing element comprises a coiled spring.

10. The lead introducer of claim 1, further comprising a Luer fitting disposed along the inner-needle proximal hub, the Luer fitting configured and arranged to receive a syringe.

11. The lead introducer of claim 10, further comprising a tube disposed in the inner-needle proximal hub and extending between the Luer fitting and a lumen of the inner-needle body.

12. The lead introducer of claim 1, wherein the inner-needle body defines a lumen extending distally from the inner-needle proximal hub.

13. The lead introducer of claim 1, wherein the splittable member comprises:

a proximal hub with at least two pull-apart tabs, and

a lumen configured and arranged for receiving the outer-needle body and the inner-needle body,

wherein the at least one perforated region is configured and arranged for separating when the at least two pull-apart tabs are pulled apart from one another in directions approximately orthogonal to the splittable member.

14. An insertion kit comprising:

the lead introducer of claim 1;

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; and

wherein the open channel of the outer needle 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.

15. An electrical stimulation system comprising:

the insertion kit of claim 14;

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 lead body of the neurostimulation lead is received by the connector housing.

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

advancing a distal end portion of 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 a distal end portion of a neurostimulation lead, the neurostimulation lead comprising a plurality of electrodes disposed along the 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;

removing the splittable member and the outer needle from the patient, leaving the neurostimulation lead implanted in the patient at a target stimulation location.

17. The method of claim 16, wherein advancing a distal end portion of the lead introducer into the patient comprises advancing the distal end portion of the lead introducer from an outer surface of the patient to an open space within the patient.

18. The method of claim 17, wherein advancing a distal end portion of the lead introducer from an outer surface of the patient to an open space within the patient comprises:

advancing the distal end portion of the lead introducer from the outer surface to the open space with the distal tip of the inner needle of the lead introducer in the retracted position; and

transitioning the distal tip of the inner needle of the lead introducer from the retracted position to the distally-biased position when the distal end portion of the lead introducer enters the open space.

19. The method of claim 17, wherein advancing a distal end portion of the lead introducer from an outer surface of the patient to an open space within the patient comprises advancing the distal end portion of the lead introducer from the outer surface of the patient to the patient'"'"'s epidural space.

20. The method of claim 17, wherein advancing a distal end portion of the lead introducer from an outer surface of the patient to an open space within the patient comprises transitioning the distal tip of the inner needle to the retracted position when the outer surface of the patient is pierced by the distal end portion of the lead introducer.