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

• US 9,700,350 B2
• Filed: 09/02/2014
• Issued: 07/11/2017
• 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:
  US14/475,426
• Publication Number:
  US 20150073432A1
• Time in Patent Office: 1,043 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 2090/0815 Implantable devices for insertion in between organs or other soft tissues
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems

Abstract

A lead introducer includes an outer needle with an outer-needle body. The outer-needle body includes a bend of at least 5° permanently formed along a distal end portion of the outer-needle body. The bend facilitates insertion of the lead introducer into an epidural space of a patient. The outer-needle body defines an open channel extending along an entire length of the outer-needle body. An inner needle is slidable along the open channel of the outer needle. The inner needle includes an inner-needle body that defines a lumen extending along an entire length of the inner-needle body. 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, the outer-needle body comprising a bend of at least 5°

permanently formed along the distal end portion of the outer-needle body, the bend configured and arranged for facilitating insertion of the lead introducer into an epidural space of a patient, the outer-needle body defining an open channel extending along the entire longitudinal length of the outer-needle body, and

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, the inner-needle body defining a lumen extending along the entire longitudinal length of the inner-needle body, wherein the inner-needle both comprises a first region having increased flexibility relative to adjacent portions of the inner-needle body, the first region disposed along the distal end portion of the inner-needle body; 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 open channel of the outer needle extends along a concave side of the bend of the outer needle.

3. The lead introducer of claim 1, wherein the bend of the outer needle is no greater than 20 degrees.

4. The lead introducer of claim 1, wherein the outer-needle body has a bend radius that is no greater than 5 cm.

5. The lead introducer of claim 1, wherein the outer-needle body has a bend radius of at least 1 cm.

6. The lead introducer of claim 1, wherein the first region comprises at least one circumferential groove defined along an outer surface of the distal end portion of the inner-needle body.

7. The lead introducer of claim 1, wherein the first region comprises a coiled spring disposed along the distal end portion of the inner-needle body.

8. The lead introducer of claim 1, further comprising a stylet configured and arranged for insertion into the lumen of the inner-needle body.

9. 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.

10. The insertion kit of claim 9, wherein the lead body is laterally separatable from the outer needle through the open channel without moving the lead body axially along the longitudinal length of the outer needle during separation.

11. The insertion kit of claim 9, wherein the neurostimulation lead further comprises one or more elements disposed along a length of the lead body that have a transverse cross-sectional shape or size that is different from a transverse cross-sectional shape or size of the lead body.

12. 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 lead body is received by the connector housing.

13. 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 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 into at least two parts along the length of a lumen of a splittable member;

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

14. The method of claim 13, wherein removing the outer needle and the splittable member from the patient comprises removing the outer needle from the patient prior to removing the splittable member from the patient.

15. The method of claim 13, wherein removing the outer needle and the splittable member from the patient comprises removing the outer needle from the patient prior to separating the splittable member into at least two parts along the length of the lumen of the splittable member.

16. The method of claim 13, further comprising disposing a stylet into the inner needle of the lead introducer prior to advancing the lead introducer into the patient.

17. 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, the outer-needle body comprising a bend of at least 5°

permanently formed along the distal end portion of the outer-needle body, the bend configured and arranged for facilitating insertion of the lead introducer into an epidural space of a patient, the outer-needle body defining an open channel extending along the entire longitudinal length of the outer-needle body, and

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, the inner-needle body defining a lumen extending along the entire longitudinal length of the inner-needle body;

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; and

at least one key rib disposed along the inner needle, the at least one key rib configured and arranged for orienting the inner needle circumferentially relative to the open channel of the outer needle.

18. The lead introducer of claim 17, wherein the at least one key rib extends along the entire longitudinal length of the inner needle.

19. 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, the outer-needle body comprising a bend of at least 5°

permanently formed along the distal end portion of the outer-needle body, the bend configured and arranged for facilitating insertion of the lead introducer into an epidural space of a patient, the outer-needle body defining an open channel extending along the entire longitudinal length of the outer-needle body, and

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, the inner-needle body defining a lumen extending along the entire longitudinal length of the inner-needle body;

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; and

a watertight liner extending along longitudinal surfaces of the lumen of the inner needle.