System and method for electrical stimulation of the lumbar vertebral column

• US 8,892,215 B2
• Filed: 12/07/2013
• Issued: 11/18/2014
• Est. Priority Date: 02/23/2011
• Status: Active Grant

• Current Assignee: John D. Lipani
• Original Assignee: John D. Lipani
• Inventors: Lipani, John D.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US14/099,910
• Publication Number:
  US 20140135876A1
• Time in Patent Office: 346 Days
• Field of Search: 607/3, 607/98, 607/102, 607/117, 607/118
• US Class Current: 607/117
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/0044 Spinal cord
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/205 for promoting a biological process
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters

Abstract

Disclosed methods and devices treat lower back pain from degenerated or injured intervertebral discs. Electrodes connected to a pulse generator deliver electrical impulses to nerves located within the posterior longitudinal ligament and posterior annulus fibrosus of lumbar intervertebral discs. Percutaneous and paddle leads containing the electrodes are disclosed. The percutaneous lead, designed to prevent inappropriate stimulation of the thecal sac, is inserted in the anterior epidural space using a special cannula and lead blank. Paddle leads are configured individually for implantation in each patient. The electrical stimulation may reduce back pain reversibly, with or without the simultaneous use of non-thermal irreversible electroporation. If such stimulation is unsuccessful, nerves in the ligament or annulus fibrosus may then be injured therapeutically without repositioning the lead, using impulses that result in heating, wherein a thermal insulator covers the thecal sac, thereby shielding nerves within the thecal sac from potential heat damage.

Claims

1. A method for relieving a discogenic lumbar back pain in a patient comprising:

positioning a plurality of electrodes within an anterior epidural space of the patient to a position adjacent to a posterior longitudinal ligament and/or a posterior annulus fibrosus;

generating one or more electrical impulses with a pulse generator; and

transmitting the electrical impulses through said electrodes to a vicinity of one or more nerves in said posterior longitudinal ligament and/or posterior annulus fibrosus;

wherein the electrical impulses are configured to relieve the pain in the patient in a Step A followed by a Step B, wherein;

Step A comprises electrical stimulation of the one or more nerves, wherein no significant heat damage is generated in any tissue of the patient;

wherein some of the one or more nerves are stimulated reversibly and/or are subjected to non-thermal irreversible electroporation; and

wherein a determination is made that the patient finds that said stimulation without significant heat damage does not substantially relieve said pain;

and Step B comprises irreversible electrical stimulation of the one or more nerves that generates significant joule heating and/or dielectric heating of proteins;

wherein all nerves within a thecal sac neighboring the anterior epidural space are substantially shielded thermally from said joule heating and/or dielectric heating; and

wherein the position of the plurality of electrodes is substantially the same during Step B as the position of the plurality of electrodes during Step A.

2. The method of claim 1 wherein the plurality of electrodes is implanted within the patient.

3. The method of claim 1 wherein a first electrode, selected from among the plurality of electrodes, is configured to be an active electrode, and wherein a return or dispersive electrode is configured to comprise one or more electrodes, selected from among the plurality of electrodes excluding the first electrode.

4. The method of claim 3 wherein the plurality of electrodes is disposed linearly along one side of a shaft of electrically insulating material, and wherein any of the electrodes selected from among the plurality of electrodes may be configured to be the active electrode.

5. The method of claim 3 wherein the plurality of electrodes is disposed non-linearly or linearly along one side of a paddle of electrically insulating material, and wherein any of the electrodes selected from among the plurality of electrodes may be configured to be the active electrode.

6. The method of claim 3 wherein the plurality of electrodes is stationary, and wherein different electrodes selected from among the plurality of electrodes are sequentially configured to be the active electrode, such that the heating occurs in parts of the posterior longitudinal ligament and/or posterior annulus fibrosus that underlie the sequentially active electrodes.

7. The method of claim 1 wherein the electrical impulses are transmitted through said electrodes substantially in one direction.

8. The method of claim 7 wherein the electrical impulses are not transmitted substantially to a thecal sac or to a spinal nerve root.

9. The method of claim 4 wherein the shaft and the electrodes are configured to be positioned within the patient percutaneously.

10. The method of claim 9 wherein a cannula is inserted through a neural foramen and adjacent to the anterior epidural space;

and wherein the electrodes and the shaft are inserted into a lumen of said cannula.

11. The method of claim 9 wherein the electrically insulating material is connected to one or more fins;

and wherein said fins are configured to inhibit rotation of the plurality of electrodes about a longest axis of said electrically insulating shaft.

12. The method of claim 11 wherein the fins are disposed perpendicularly to a sole direction in which the electrical impulses are transmitted.

13. The method of claim 12, wherein a lead, comprising the fins, the electrically insulating shaft, and the electrodes disposed along one side of the shaft, is coated with a thermally insulating material on a side of the lead that is opposite the electrodes.

14. The method of claim 1 wherein the plurality of electrodes is disposed along a first side of an electrically insulating paddle;

and wherein a length, and/or a width, and/or a perimeter of said electrically insulating material is configured to fit within a measured dimension and/or a measured surface area of one or more lumbar discs of the patient, or wherein said insulating material is configured to fit within a measured distance between two adjacent ipsilateral nerve roots of the patient.

15. The method of claim 14 wherein the electrically insulating paddle and the plurality of electrodes are positioned to a vicinity of a single intervertebral disc of the patient.

16. The method of claim 14 wherein the electrically insulating paddle and the plurality of electrodes are positioned to a vicinity of two or more intervertebral discs of the patient and/or to a vicinity of intervening vertebral bodies of said discs.

17. The method of claim 14 wherein a thermally insulating material coats a second side of the electrically insulating paddle, wherein the second side is opposite the first side.

18. The method of claim 17 wherein the thermally insulating material comprises a ceramic foam.

19. The method of claim 1 wherein the electrical impulses comprise rectangular pulses of adjustable rate, adjustable duration and adjustable amplitude for each electrode among the plurality of electrodes.

20. The method of claim 1 wherein the electrical impulses comprise pulses having a frequency of between about 10 kHz and 50 kHz.

21. The method of claim 1 wherein the heating in a vicinity of the posterior longitudinal ligament and/or the posterior annulus fibrosus is monitored using a temperature sensor.

22. The method of claim 21 wherein the temperature sensor is a thermocouple, thermistor, silicon band gap temperature sensor, or resistance temperature detector.

23. The method of claim 21 wherein a duration of heating and a temperature during heating are selected to effect a therapeutic thermal dose for the patient.

24. The method of claim 1 further comprising the performance of intra-operative electrophysiological monitoring, wherein potential damage to nerves within the thecal sac is assessed.

25. A device for relieving a discogenic lumbar back pain in a patient comprising:

a plurality of electrodes that is coupled to an electrical pulse generator; and

a thermal insulator;

wherein the plurality of electrodes and the thermal insulator are configured to be positioned within an anterior epidural space of the patient at a position adjacent to a posterior longitudinal ligament and/or a posterior annulus fibrosus;

wherein the pulse generator is configured to transmit electrical impulses through said electrodes;

wherein the electrical impulses may be configured to relieve the pain in the patient through;

(A) electrical stimulation of one or more nerves within the posterior longitudinal ligament and/or the posterior annulus fibrosus, wherein some of the one or more nerves are stimulated reversibly and/or are subjected to non-thermal irreversible electroporation; and

wherein no significant heat damage is generated in any tissue of the patient; and

in an alternate selectable configuration of the electrical impulses, through;

(B) irreversible electrical stimulation of the one or more nerves that generates significant joule heating and/or dielectric heating of proteins;

wherein the thermal insulator is configured to cover a thecal sac such that all nerves within said thecal sac are substantially shielded from said joule and/or dielectric heating; and

wherein electrical impulse configurations (A) and (B) are configured for use when the plurality of electrodes resides in a stationary position within the anterior epidural space of the patient.

26. The device of claim 25 wherein the electrodes are configured to be implanted within the patient.

27. The device of claim 25 wherein a first electrode selected from among the plurality of electrodes may be configured to be an active electrode, and wherein a return or dispersive electrode may be configured to comprise one or more electrodes selected from among the plurality of electrodes excluding the first electrode.

28. The device of claim 27 wherein the plurality of electrodes is disposed linearly along one side of a shaft of electrically insulating material, and wherein any of the electrodes among the plurality of electrodes may be configured to be the active electrode.

29. The device of claim 27 wherein the plurality of electrodes is disposed non-linearly or linearly along one side of a paddle of electrically insulating material, and wherein any of the electrodes among the plurality of electrodes may be configured to be the active electrode.

30. The device of claim 25 wherein the electrical impulses are configured to be transmitted through the electrodes substantially in one direction.

31. The device of claim 28 wherein the shaft and the electrodes are configured to be positioned within the patient percutaneously.

32. The device of claim 31 further comprising a cannula, wherein the electrodes and the shaft are configured to be inserted into a lumen of said cannula.

33. The device of claim 31 wherein the electrically insulating shaft is connected to one or more fins;

and wherein said fins are configured to inhibit rotation of the plurality of electrodes about a longest axis of said electrically insulating shaft when said shaft is positioned within the anterior epidural space of the patient.

34. The device of claim 33 wherein the fins are disposed perpendicularly to a sole direction in which the electrical impulses are configured to be transmitted.

35. The device of claim 25 wherein the plurality of electrodes is disposed nonlinearly or linearly along a first side of an electrically insulating paddle;

and wherein a length, and/or a width, and/or a perimeter of said electrically insulating material is configured to fit within a measured dimension and/or a measured surface area of one or more lumbar discs of the patient, or wherein said insulating material is configured to fit within a measured distance between two adjacent ipsilateral nerve roots of the patient.

36. The device of claim 35 wherein a thermally insulating material is disposed along a second side of the electrically insulating paddle, wherein the second side is opposite the first side.

37. The device of claim 36 wherein the thermally insulating material comprises a ceramic foam.

38. The device of claim 25 wherein the electrical impulses are configured to comprise rectangular pulses of adjustable rate, adjustable duration and adjustable amplitude for each electrode among the plurality of electrodes.

39. The device of claim 25 wherein the electrical impulses are configured to have a frequency of between about 10 kHz and 50 kHz.

40. The device of claim 25 further comprising a temperature sensor.

41. The device of claim 40 wherein the temperature sensor is a thermocouple, thermistor, silicon band gap temperature sensor, or resistance temperature detector.

42. The device of claim 25, and further comprising a trocar, or a guide wire, or a stylet, or an introducer cannula, or an obturator, or a lead blank;

wherein the trocor, or the guide wire, or the stylet, or the introducer cannula, or the obturator, or the lead blank is configured for the placement into the patient of the device of claim 25.

43. A device for relieving a discogenic lumbar back pain in a patient comprising:

a plurality of electrodes that is coupled to an electrical pulse generator; and

a thermal insulator;

wherein the plurality of electrodes and the thermal insulator are configured to be implanted within an anterior epidural space of the patient at a fixed position adjacent to a posterior longitudinal ligament and/or a posterior annulus fibrosus;

wherein the pulse generator is configured to transmit electrical impulses through said electrodes;

wherein said electrical impulses are configured to relieve the pain in the patient through electrical stimulation in the vicinity of one or more nerves in said posterior longitudinal ligament and/or said posterior annulus fibrosus;

wherein said electrical impulses generate therapeutically significant joule heating and/or dielectric heating of proteins;

wherein a selectable electrode among the plurality of electrodes may be configured to be an active electrode, and wherein a return or dispersive electrode may be configured to comprise one or more electrodes selected from among the plurality of electrodes excluding the active electrode; and

wherein the thermal insulator is configured to cover a thecal sac such that all nerves within said thecal sac are shielded to prevent an iatrogenesis that would arise from heating of said thecal sac.