SYSTEM AND METHOD FOR MAKING AND USING A SPLITABLE LEAD INTRODUCER FOR AN IMPLANTABLE ELECTRICAL STIMULATION SYSTEM

• US 20110224681A1
• Filed: 03/10/2011
• Published: 09/15/2011
• Est. Priority Date: 03/15/2010
• Status: Abandoned Application

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: McDonald, Matthew Lee
• Application Number:
  US13/044,941
• Publication Number:
  US 20110224681A1
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• 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 25/0668 splittable, tear apart
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

A lead introducer includes a split-release insertion needle configured and arranged for insertion into an epidural space of a patient. The split-release insertion needle has a proximal end, a distal end, and a longitudinal axis. The split-release insertion needle includes a plurality of body elements that laterally mate along the longitudinal axis of the split-release insertion needle. When the plurality of body elements are mated, the plurality of body elements define a lumen along the longitudinal axis of the split-release insertion needle. The lumen is configured and arranged to receive a distal end of a neurostimulation lead. A removable retaining member is disposed over at least a portion of each of the plurality of body elements. The plurality of body elements are configured and arranged to at least partially separate from one another when the retaining member is removed from the plurality of body elements.

Claims

1. A lead introducer comprising:

a split-release insertion needle configured and arranged for insertion into an epidural space of a patient, the split-release insertion needle having a proximal end, a distal end, and a longitudinal axis, the split-release insertion needle comprising a plurality of body elements that laterally mate along the longitudinal axis of the split-release insertion needle, wherein when the plurality of body elements are mated, the plurality of body elements define a lumen along the longitudinal axis of the split-release insertion needle, wherein the lumen is configured and arranged to receive a distal end of a neurostimulation lead; and

a removable retaining member disposed over at least a portion of each of the plurality of body elements;

wherein the plurality of body elements are configured and arranged to at least partially separate from one another when the retaining member is removed from the plurality of body elements.

2. The lead introducer of claim 1, wherein a one of the plurality of body elements comprises a first interlocking feature and another of the plurality of body elements comprises a second interlocking feature that corresponds to the first interlocking feature such that when the plurality of body elements mate along the longitudinal axis of the split-release insertion needle, the interlocking features maintain alignment of the plurality of body elements along at least one of the longitudinal axis of the split-release insertion needle or an axis transverse to the longitudinal axis of the split-release insertion needle.

3. The lead introducer of claim 1, wherein the split-release insertion needle comprises two, three, or four body elements.

4. The lead introducer of claim 1, wherein the plurality of body elements are configured and arranged to separate from one another such that at least one of the plurality of body elements completely separates from the other body elements when the retaining member is removed from the plurality of elements.

5. The lead introducer of claim 1, wherein the plurality of body elements are configured and arranged to separate from one another when the retaining member is removed from the plurality of elements such that at least two of the plurality of body elements remain at least partially attached to one another.

6. The lead introducer of claim 5, wherein the split-release insertion needle further comprises a hinge coupling two of the plurality of body elements to one another.

7. The lead introducer of claim 1, wherein the retaining member is heat shrink tubing.

8. The lead introducer of claim 1, wherein the retaining member is disposed over an entire length of the split-release insertion needle.

9. The lead introducer of claim 1, wherein the retaining member provides a watertight seal within the lumen of the split-release insertion needle.

10. The lead introducer of claim 1, wherein the retaining member is configured and arranged to roll up along or to slide along the longitudinal axis of the split-release insertion needle.

11. The lead introducer of claim 1, wherein the retaining member is configured and arranged to be torn into a plurality of pieces or split along a longitudinal axis of the retaining member.

12. An insertion kit comprising:

the lead introducer of claim 1;

a neurostimulation lead with a distal end configured and arranged for implantation into a patient, the neurostimulation lead comprising

a lead body having a distal end and a proximal end,

a plurality of electrodes disposed at the distal end of the lead body,

a plurality of terminals disposed at the proximal end of the lead body, and

a plurality of conductive wires coupling the plurality of electrodes electrically to the plurality of terminals; and

wherein the lumen of the split-release insertion needle is configured and arranged to receive the distal end of the lead body.

13. The insertion kit of claim 12, wherein the lead body is insertable into the lumen of the split-release insertion needle such that after insertion into the lumen, the lead body is separatable from the split-release insertion needle without sliding the lead body axially along the lumen of the split-release insertion needle.

14. The insertion kit of claim 12, wherein the lead body is non-isodiametric.

15. An electrical stimulation system comprising:

the insertion kit of claim 12;

a control module configured and arranged to electrically couple to the proximal end of the lead body, 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 of the lead body, and

a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple to at least one terminal disposed at the proximal end of the lead body.

16. The electrical stimulation system of claim 15, further comprising a lead extension having a proximal end and a distal end, the connector disposed on the distal end of the lead extension.

17. The electrical stimulation system of claim 16, wherein the proximal end of the lead extension is configured and arranged for insertion into another connector.

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

inserting a lead introducer into the patient, the lead introducer comprising a split-release insertion needle disposed in a removable retaining member, the split-release insertion needle comprising a plurality of body elements laterally mated with one another along a longitudinal axis of the split-release insertion needle to define a lumen extending along a length of the split-release insertion needle;

inserting into the lumen of the splitable insertion needle a distal end of a neurostimulation lead, the neurostimulation lead comprising a plurality of electrodes disposed along the distal end of the neurostimulation lead and a plurality of terminals disposed along at least one proximal end of the neurostimulation lead;

guiding the lead introducer in proximity to a target stimulation location within the patient;

removing the retaining member from the plurality of body elements, thereby causing the at least two of the plurality of body elements to at least partially separate from one another along the longitudinal axis of the split-release insertion needle; and

removing the at least two body elements from the neurostimulation lead, leaving at least the distal end of the neurostimulation lead implanted in the patient.

19. The method of claim 18, wherein removing the retaining member from the at least two body elements comprises rolling up or sliding the removable retaining member along the longitudinal axis of the split-release insertion needle.

20. The method of claim 18, wherein removing the retaining member from the at least two body elements comprises tearing up the retaining member into a plurality of pieces or splitting the retaining member along a longitudinal axis of the retaining member.