SINGLE AND MULTIPOLAR IMPLANTABLE LEAD FOR SACRAL NERVE ELECTRICAL STIMULATION

• US 20080188917A1
• Filed: 04/08/2008
• Published: 08/07/2008
• Est. Priority Date: 04/29/1999
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Swoyer, John M., Gerber, Martin T.
• Application Number:
  US12/099,326
• Publication Number:
  US 20080188917A1
• Time in Patent Office: Days
• US Class Current: 607/117
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

An implantable medical lead for stimulation of the sacral nerves comprises a lead body which includes a distal end and a proximal end, and the distal end having at least one electrode contact extending longitudinally from the distal end toward the proximal end. The lead body at its proximal end may be coupled to a pulse generator, additional intermediate wiring, or other stimulation device. The electrode contact of the permanently implantable neurostimulation lead comprises an elongated, flexible, coiled wire or mesh electrode having an exposed electrode length that is adapted to be inserted through the foramen from a posterior access to locate the coiled wire electrode alongside the sacral nerve extending anteriorly and/or posteriorly therefrom. The coiled wire or mesh electrode structure is flexible and bendable to enable its placement through the foramen and alongside the sacral nerve and to conform to the surrounding nerves and tissue. Preferably, further shorter length electrodes are provided along the distal segment of the lead body to enable testing of the positioning of the elongated wire coil or mesh electrode or to provide alternate stimulation electrodes upon dislocation of the elongated wire coil or mesh electrode.

Claims

1-20. -20. (canceled)

21. A method of implanting a medical lead near a sacral nerve of a patient comprising:

making an incision in the patient to expose the sacral foramen; and

inserting a medical lead into the incision,

wherein the medical lead comprises;

a lead body extending between lead proximal and distal ends, the lead body having an internal lumen shaped to accept a stylet;

a coil electrode disposed near the distal end of the lead body;

a first ring electrode disposed distal the coil electrode;

a second ring electrode disposed proximal the coil electrode; and

at least one proximal connector element located on the proximal end of the lead body,

wherein at least the coil electrode is located at least adjacent to a sacral nerve that is within the sacral foramen.

22. The method according to claim 21, wherein exposing the sacral foramen further comprises splitting the paraspinal muscle fibers.

23. The method according to claim 21 further comprising anchoring the lead in place.

24. The method according to claim 21, wherein at least the coil electrode is placed in contact with the sacral nerve.

25. The method according to claim 21, wherein the coil electrode has a length from about 10 mm to about 38 mm.

26. The method according to claim 21, wherein the sacral nerve is the S1, S2, S3, or S4 sacral nerve.

27. The method according to claim 21, wherein the sacral nerve is the S3 sacral nerve.

28. The method of claim 21 further comprising inserting an insulated needle having both ends electrically exposed into the incision before the medical lead is inserted into the incision.

29. The method of claim 28, wherein the needle is electrically stimulated using an external pulse generator.

30. The method according to claim 29, wherein the location of the needle is tested by evaluating the physiologic response of the patient and the electrical threshold required to get that response.

31. The method according to claim 21, wherein a stylet is inserted into the lumen of the lead body before the lead is inserted into the incision.

32. The method according to claim 31, wherein a cannula is inserted in the incision of the patient before the lead is inserted into the incision.

33. The method according to claim 32, wherein the lead is passed through the cannula to reach the sacral foramen.

34. The method according to claim 31 further comprising removing the stylet from the lumen of the lead body.

35. The method according to claim 21 further comprising coupling the at least one proximal connector element to a neurostimulation pulse generator, another stimulation device or additional intermediate wiring.

36. A method of implanting a medical lead in a patient comprising:

making an incision in the patient to expose the sacral foramen;

inserting a needle into the incision of the patient to locate the proximity of a nerve to be stimulated, wherein the needle is an insulated needle with both ends exposed for electrical stimulation;

electrically stimulating the needle using an external pulse generator in order to test the location of the needle by evaluating the physiologic response and the electrical threshold required to get that response;

removing the needle from the evaluated location;

inserting a medical lead into the evaluated location,

wherein the medical lead comprises;

a lead body extending between lead proximal and distal ends;

a coil electrode disposed near the distal end of the lead body;

a first ring electrode disposed distal the coil electrode;

a second ring electrode disposed proximal the coil electrode; and

at least one proximal connector element located on the proximal end of the lead body; and

connecting the at least one proximal connector element to a neurostimulation pulse generator, another stimulation device, or intermediate wiring.

37. The method according to claim 36, wherein the coil electrode has a length from about 10 mm to about 38 mm.

38. The method according to claim 36, wherein the location of the needle is changed and the electrical stimulation of the needle is carried out again until a desired physiologic response and electrical threshold are required.

39. The method according to claim 36, wherein the needle is removed from the evaluated location before the medical lead is inserted.

40. The method according to claim 36, wherein the needle is removed from the evaluated location after the medical lead is inserted.