Epidural nerve root stimulation with lead placement method

• US 6,104,957 A
• Filed: 08/21/1998
• Issued: 08/15/2000
• Est. Priority Date: 08/21/1998
• Status: Expired due to Term

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Claudio A. Feler, Kenneth M. Alo
• Inventors: Alo, Kenneth M., Feler, Claudio A.
• Primary Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US09/138,065
• Time in Patent Office: 725 Days
• Field of Search: 128/899, 128/898, 607/2, 607/46, 607/117, 607/118, 600/26
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

A method of managing chronic pain and/or symptoms of motor dysfunction produced by a variety of disorders or conditions. The method includes techniques for positioning one or more stimulation leads so as to enable delivery of electrical energy to epidural spinal nervous tissue, spinal ganglia, nerve plexi, or peripheral nerves using superior-to-inferior and/or trans-spinal advancement relative to a vertebral column and stimulating selected spinal nervous tissue.

Claims

1. A method of administering particularized electrical energy to spinal nervous tissue using a signal generator and at least one stimulation lead having an electrode portion and a connector portion, where the connector portion may be electrically coupled to the signal generator, the method comprising the steps of:

inserting the at least one stimulation lead between a first vertebra and a second vertebra and into an epidural space and advancing the stimulation lead in an inferior direction, substantially parallel to a longitudinal direction of the epidural space;

positioning the stimulation lead so that the electrode portion of the stimulation lead lies in a plane substantially parallel to selected spinal nervous tissue, the selected spinal nervous tissue including at least one of;

epidural spinal nervous tissue, spinal ganglion, neural plexus, and peripheral nerves;

coupling the at least one stimulation lead to the signal generator; and

delivering electrical energy from the signal generator to the electrode portion of the at least one stimulation lead.

2. A method in accordance with claim 1, wherein a distal end of the stimulation lead is positioned with a cervical region, wherein the distal end of the stimulation lead is at or between a C1, C2, C3, or C4 vertebral position.

3. A method in accordance with claim 1, wherein a distal end of the stimulation lead is positioned with a cervicobrachial region, wherein the distal end of the stimulation lead is at or between a C5, C6, or C7, vertebral position.

4. A method in accordance with claim 1, wherein a distal end of the stimulation lead is positioned with a thoracic region, wherein the distal end of the stimulation lead is at or between a T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, or T12 vertebral position.

5. A method in accordance with claim 1, wherein a distal end of the stimulation lead is positioned with a lumbar region, wherein the distal end of the stimulation lead is at or between an L1, L2, L3, L4, or L5 vetebral position.

6. A method in accordance with claim 1, wherein a distal end of the stimulation lead is positioned within a sacral region, wherein the distal end of the stimulation lead is at or between S1, S2, S3, S4, or S5.

7. A method in accordance with claim 1, wherein the stimulation lead extends, at least in part, through an intervertebral foramen.

8. A method in accordance with claim 1, wherein delivered electrical energy inhibits transmission of sensory signals within the selected spinal nervous tissue.

9. A method in accordance with claim 1, wherein delivered electrical energy affects transmission of motor signals within the selected spinal nervous tissue.

10. A method in accordance with claim 1, wherein delivered electrical energy affects transmission of sensory signals within the selected spinal nervous tissue.

11. A method in accordance with claim 1, wherein delivered electrical energy inhibits transmission of motor signals within the selected spinal nervous tissue.

12. A method of administering particularized electrical energy to spinal nervous tissue using a signal generator and at least one stimulation lead having an electrode portion and a connector portion, where the connector portion may be electrically coupled to the signal generator, the method comprising the steps of:

inserting the at least one stimulation lead between a first vertebra and a second vertebra and into an epidural space and advancing the stimulation lead in an inferior direction, wherein the stimulation lead transverses, whether obliquely or laterally, the epidural space;

positioning the stimulation lead so that the electrode portion of the stimulation lead lies in a plane substantially parallel to selected spinal nervous tissue, the selected spinal nervous tissue including at least one of;

epidural spinal nervous tissue, spinal ganglion, nerve plexus, and peripheral nerves;

coupling the at least one stimulation lead to the signal generator; and

delivering electrical energy from the signal generator to the electrode portion of the at least one stimulation lead.

13. A method in accordance with claim 12, wherein a plurality of stimulation leads are implanted and coupled to at least one signal generator.

14. A method in accordance with claim 12, wherein a distal end of the stimulation lead is positioned with a cervical region, wherein the distal end of the stimulation lead is at or between a C1, C2, C3, or C4 vertebral position.

15. A method in accordance with claim 12, wherein a distal end of the stimulation lead is positioned with a cervicobrachial region, wherein the distal end of the stimulation lead is at or between a C5, C6, or C7 vertebral position.

16. A method in accordance with claim 12, wherein a distal end of the stimulation lead is positioned with a thoracic region, wherein the distal end of the stimulation lead is at or between a T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, or T12 vertebral position.

17. A method in accordance with claim 12, wherein a distal end of the stimulation lead is positioned with a lumbar region, wherein the distal end of the stimulation lead is at or between an L1, L2, L3, L4, or L5 vertebral position.

18. A method in accordance with claim 12, wherein a distal end of the stimulation lead is positioned within a sacral region, wherein the distal end of the stimulation lead is at or between S1, S2, S3, S4, or S5.

19. A method in accordance with claim 12, wherein the stimulation lead extends, at least in part, through an intervertebral foramen.

20. A method in accordance with claim 12, wherein delivered electrical energy affects transmission of sensory signals within the selected spinal nervous tissue.

21. A method in accordance with claim 12, wherein delivered electrical energy affects transmission of motor signals within the selected spinal nervous tissue.

22. A method of administering particularized electrical energy to spinal nervous tissue using a signal generator and at least one stimulation lead having an electrode portion and a connector portion, where the connector portion may be electrically coupled to the signal generator, the method comprising the steps of:

inserting the at least one stimulation lead into an epidural space at or superior to a desired vertebral placement position;

positioning the at least one stimulation lead so that the electrode portion of the stimulation lead lies in a plane substantially parallel to selected spinal nervous tissue and is capable of directly influencing, through delivery of electrical energy, at least one of;

nerve tissue within the epidural space, spinal ganglia, a nerve plexus, and a peripheral nerve;

coupling the at least one stimulation lead to the signal generator; and

delivering electrical energy from the signal generator to the electrode portion of the at least one stimulation lead.

23. A method in accordance with claim 22, wherein delivered electrical energy affects transmission of sensory signals within the selected spinal nervous tissue.

24. A method in accordance with claim 22, wherein delivered electrical energy affects transmission of motor signals within the selected spinal nervous tissue.

25. A method of administerin particularized electrical energy to spinal nervous tissue using a signal generator and at least one stimulation lead having an electrode portion and a connector portion, where the connector portion may be electrically coupled to the signal generator, the method comprising the steps of:

inserting the at least one stimulation lead between a first vertebra and a second vertebra and into an epidural space and advancing the stimulation lead in an inferior direction, substantially parallel to a longitudinal direction of the epidural space;

positioning the stimulation lead so that the electrode portion of the stimulation lead lies in a plane substantially parallel to selected spinal nervous tissue having corresponding nerve roots originating superior to an S1 vertebral position, the selected spinal nervous tissue including at least one of;

epidural spinal nervous tissue, spinal ganglion, neural plexus, and peripheral nerves;

coupling the at least one stimulation lead to the signal generator; and

delivering electrical energy from the signal generator to the electrode portion of the at least one stimulation lead.

26. A method in accordance with claim 25, wherein a distal end of the stimulation lead is positioned within a cervical region, wherein the distal end of the stimulation lead is at or between a C1, C2, C3, or C4 vetebral position.

27. A method in accordance with claim 25, wherein a distal end of the stimulation lead is positioned within a cervicobrachial region, wherein the distal end of the stimulation lead is at or between a C5, C6, or C7 vertebral position.

28. A method in accordance with claim 25, wherein a distal end of the stimulation lead is positioned within a thoracic region, wherein the distal end of the stimulation lead is at or between a T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, or T12 vertebral positiion.

29. A method in accordance with claim 25, wherein a distall end of the stimulation lead is positioned within a lumbar region, wherein the distal end of the stimulation lead is at or between an L1, L2, L3, L4, or L5 vertebral position.

30. A method in accordance with claim 25, wherein a distal end of the stimulation lead is positioned at or inferior to an S1 vertebral position.

31. A method in accordance with claim 25, wherein the stimulation lead extends, at least in part, through an intervertebral foramen.

32. A method in accordance with claim 25, wherein delivered electrical energy inhibits transmission of sensory signals within the selected spinal nervous tissue.

33. A method in accordance with claim 25, wherein delivered electrical energy affects transmission of motor signals within the selected spinal nervous tissue.

34. A method in accordance with claim 25, wherein delivered electrical energy affects transmission of sensory signals within the selectred spinal nervous tissue.

35. A method in accordance with claim 25, wherein delivered electrical energy inhibits transmission of motor signals within the selected spinal nervous tissue.

36. A method in accordance with claim 25, wherein a distal end of the stimulation lead is placed at an intraspinal position.

37. A method of administering particularized electrical energy to spinal nervous tissue using a signal generator and at least on stimulation lead having an electrode portion and a connector portion, where the connector portion may be electrically coupled to the signal generator, the method comprising the steps of:

inserting the at least one stimulation lead into an epidural space at or superior to a desired bertebral plaement position;

positioning the at least one stimulation lead so that the electrode portion of the stimulation lead (i) lies in a plane substantially parallel to selected spinal nervous tissue having corresponding nerve roots originating superior to an S1 vertebral position and (ii) is capable of directly influencing, through delivery of electrical energy, at least one of;

nerve tissue within the epidural space, spinal ganglia, a nerve plexus, and a peripheral nerve;

coupling the at least one stimulation lead to the signal generator; and

delivering electrical energy from the signal generator to the electrode portion of the at least one stimulation lead.

38. A method in accordance with claim 37, wherein delivered electrical energy affects transmission of sensory signals within the selected spinal nervous tissue.

39. A method in accordance with claim 37, wherein delivered electrical energy affects transmission of motor signals within the selected spinal nervous tissue.

40. A method of managing effects of a motor disorder using a signal generator and at least one stimulation lead having an electrode portion and a connector portion, where the connector portion is electrically connectable to the signal generator, the method comprising the steps of:

surgically implanting the at least one stimulation lead so that the electrode portion of the at least one stimulation lead lies in a plane substantially parallel to selected sacral spinal nervous tissue within an epidural space of a sacrum;

coupling the at least one stimulation lead to the signal generator; and

delivering electrical energy from the signal generator to the electrode portion of the at least one stimulation lead so as to affect a transmission of motor signals within the selected sacral spinal nervous tissue for purposes of managing effects of the motor disorder,

wherein a distal end of the stimulation lead is finally positioned at or between and S1, S2, S3, S4, or S5 sacral position.

41. A method of managing effects of a motor disorder using at least one signal generator and at least one stimulation lead having an electrode portion and a connector portion, where the connector portion is electrically connectable to the signal generator, the method comprising the steps of:

inserting the at least one stimulation lead at a vertebral position superior to S1/S2 into epidural space and advancing the stimulation lead in an inferior direction, substantially parallel to a longitudinal direction of the epidural space;

positioning the stimulation lead so that the electrode portion of the stimulation lead lied in a plane substantially parallel to selected sacral nerve roots within the epidural space of a sacrum;

coupling the at least one stimulation lead to the signal generator; and

delivering electrical energy from the signal generator to the electrode portion of the at least one stimulation lead so as to affect a transmission of motor signals within the selected sacral nerve roots for purposes of managing effects of the motor disorder,

wherein a distal end of the stimulation lead is finally positioned at or between an S1, S2, S3, S4, or S5 sacral position.

42. A method of managing effects of a motor disorder using a signal generator and at least one stimulation lead having an electrode portion and a connector portion, where the connector portion is electrically connectable to the signal generator, the method comprising the steps of:

inserting the at least one stimulation lead at a vetebral position superior to S1/S2 into an epidural space and advancing the stimulation lead in an inferior direction, substantially parallel to a longitudinal direction of the epidural space;

positioning the lead so that the electrode portion of the lead lies in a plane substantially parallel to selected sacral nerve roots and is capable of directly influencing, through delivery of electrical energy, at least one of;

nerve tissue within the epidural space of a sacrum, a dorsal root ganglia of the sacrum, a sacral nerve plexus, and a peripheral nerve of a pelvic region;

coupling the at least one stimulation lead to the signal generator; and

delivering electrical energy from the signal generator to the electrode portion of the at least one stimulation lead so as to affect a transmission of motor signals within the selected sacral nerve roots for purposes of managing effects of the motor disorder,

wherein a distal end of the at least one stimulation lead is finally positioned at or between an S1, S2, S3, S4, or S5 sacral position.