Positive fixation percutaneous epidural neurostimulation lead

• US 5,733,322 A
• Filed: 05/23/1995
• Issued: 03/31/1998
• Est. Priority Date: 05/23/1995
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Starkebaum, Warren L.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US08/447,376
• Time in Patent Office: 1,043 Days
• Field of Search: 607/117, 607/116, 607/122, 607/126
• US Class Current: 607/117
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

A neurological epidural lead is disclosed having an extension that extends distally beyond the most distal electrode. The length of the extension corresponds to the length of one ore more vertebral segments. The lead is placed in the epidural space so that the electrodes are positioned as desired. In positioning the electrodes, the extension passes through at least one area where the epidural space between the dura and the spinal canal wall is very narrow because the dura and spinal canal wall are in contact. As a result, the extension is held in place by contact with both the dura and spinal canal wall so that lateral lead migration of the electrodes is minimized.

Claims

1. A neurological epidural lead having a proximal end and a distal end, the lead comprising:

a body having at least two electrodes attached thereto near the distal end of the lead;

a connector attached at the proximal end of the lead;

wires connecting the electrodes to the connector;

an extension extending distally beyond the most distal electrode, the extension adapted to remain entirely within the epidural space of a spinal column, wherein the length of the extension corresponds to the length of at least one vertebral segment.

2. A lead according to claim 1 wherein the body is made of an electrically non-conducting material.

3. A lead according to claim 2 wherein the electrically non-conducting material is selected from a group consisting of polyurethane, polypropylene and silicone.

4. A lead according to claim 1 wherein the body is made of a material that is inert to body tissue.

5. A lead according to claim 1 wherein the electrodes are made of a conducting metal.

6. A lead according to claim 1 wherein the electrodes encircle the body.

7. A lead according to claim 1 wherein the number of electrodes is four.

8. A lead according to claim 1 wherein the number of electrodes is eight.

9. A lead according to claim 1 wherein the length from the most proximal electrode to the most distal electrode is about 30 millimeters.

10. A lead according to claim 1 wherein the electrodes are spaced from each other by portions of the body so that there is an electrically insulating space between each of the electrodes.

11. A lead according to claim 1 wherein the wires pass through the interior of the body.

12. A lead according to claim 1 wherein the extension is made of the same material as the body.

13. A lead according to claim 1 further comprising a stiffening member attached to the extension to add rigidity to the extension.

14. A lead according to claim 13 wherein the stiffening member is enclosed within the extension.

15. A lead according to claim 13 wherein the stiffening member is made of a material chosen from the group consisting of polymeric material and metallic material having a stiffness greater than a corresponding volume of material that the body is made of.

16. A lead according to claim 1 wherein the length of the extension is approximately 9 to 90 millimeters in length.

17. A lead according to claim 16 wherein the length of the extension is approximately 15 to 30 millimeters in length.

18. A lead according to claim 1 wherein the length of the extension is approximately 9 to 45 millimeters in length.

19. A lead according to claim 1 wherein the extension includes means for enhancing the extensions ability to be retained within the epidural space.

20. A lead according to claim 19 wherein the means for enhancing the extensions ability to be retained within the epidural space include texturing the outer surface of the extension to enhance the frictional contact between the extension and the dura and spinal canal wall.

21. A lead according to claim 20 wherein the texturing added to the outer surface of the extension includes texturing chosen from the group consisting of dimples, ridges and grooves.

22. A lead according to claim 19 wherein the means for enhancing the extensions ability to be retained within the epidural space includes adding protrusions to the outer surface of the extension to enhance the frictional contact between the extension and the dura and spinal canal wall.

23. A system for producing parasthesia in a patient comprising:

a neurological epidural lead having a proximal end and a distal end, the lead comprising;

a body having at least two electrodes attached thereto near the distal end of the lead;

a connector attached at the proximal end of the lead;

wires connecting the electrodes to the connector;

an extension extending distally beyond the most distal electrode, the extension adapted to remain entirely in the epidural space of a spinal column, wherein the length of the extension corresponds to the length of at least one vertebral segment; and

an implantable electrical pulse generator electrically connected to the wires.

24. A method for anchoring a neurological epidural lead in the epidural space of a patient, the method comprising the steps of:

providing a lead having a proximal end and a distal end, the lead having a body with at least two electrodes attached thereto near the distal end of the lead, a connector attached at the proximal end of the lead, wires connecting the electrodes to the connector and an extension extending distally beyond the most distal electrode for a distance corresponding to the length of at least one vertebral segment, the extension adapted to remain entirely in the epidural space of a spinal column;

inserting the lead into a needle having a proximal and a patient contacting distal end, the extension being coterminous with the distal end of the needle;

inserting the needle into a spinal column through a spinal canal wall;

puncturing the ligamentum flavum with the needle to produce a small opening into the epidural space;

pushing the lead out of the needle upward in the epidural space until the electrodes are in the desired location and the extension passes through at least one location in the epidural space where the dura and the spinal canal wall are in contact and wherein the distal end of the lead is retained entirely within the epidural space;

removing the needle;

whereby contact between the extension and the dura and spinal canal wall hold the extension in a fixed relation within the epidural space.

25. The method of claim 24 further comprising the step of anchoring the proximal end of the lead outside the spinal column to prevent axial movement of the lead.

26. A method according to claim 24 wherein the step of providing a lead includes the step of providing a lead having means for enhancing the extension'"'"'s ability to be retained within the epidural space.

27. A neurological epidural lead having a proximal end and a distal end, the lead comprising:

a body having at least two electrodes attached thereto near the distal end of the lead;

a connector attached at the proximal end of the lead;

wires connecting the electrodes to the connector;

an extension extending distally beyond the most distal electrode, the extension adapted to remain entirely within the epidural space of a spinal column, wherein the length of the extension is approximately 9 to 90 millimeters in length.

28. A lead according to claim 27 wherein the length of the extension is approximately 15 to 30 millimeters in length.

29. A lead according to claim 27 wherein the length of the extension is approximately 9 to 45 millimeters in length.

30. A lead according to claim 27 wherein the extension includes means for enhancing the extensions ability to be retained within the epidural space.

31. A method for anchoring a neurological epidural lead in the epidural space of a patient, the method comprising the steps of:

providing a lead having a proximal end and a distal end, the lead having a body with at least two electrodes attached thereto near the distal end of the lead, a connector attached at the proximal end of the lead, wires connecting the electrodes to the connector and an extension extending distally beyond the most distal electrode for a distance of approximately 9 to 90 millimeters, the extension adapted to remain entirely in the epidural space of a spinal column;

inserting the lead into a needle having a proximal and a patient contacting distal end, the extension being coterminous with the distal end of the needle;

inserting the needle into a spinal column through a spinal canal wall;

puncturing the ligamentum flavum with the needle to produce a small opening into the epidural space;

pushing the lead out of the needle upward in the epidural space until the electrodes are in the desired location and the extension passes through at least one location in the epidural space where the dura and the spinal canal wall are in contact and wherein the distal end of the lead is retained entirely within the epidural space;

removing the needle;

whereby contact between the extension and the dura and spinal canal wall hold the extension in a fixed relation within the epidural space.

32. A method according to claim 31 wherein the step of providing a lead includes the step of providing a lead having means for enhancing the extension'"'"'s ability to be retained within the epidural space.