System and method for electrical stimulation of the lumbar vertebral column

• US 8,880,189 B2
• Filed: 02/22/2012
• Issued: 11/04/2014
• 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:
  US13/402,093
• Publication Number:
  US 20120215218A1
• Time in Patent Office: 986 Days
• Field of Search: 607/117, 607/116
• 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 chronic 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 annulus fibrosus of lumbar intervertebral discs. The stimulation reduces back pain reversibly, adjustably, and with almost complete coverage of the pain-generating region. A temporary percutaneous lead and a permanent paddle lead are used. The percutaneous lead, designed to prevent inappropriate stimulation of the thecal sac, is inserted using a specially-designed introducer cannula and lead blank. The paddle lead is configured individually for implantation in the anterior epidural space of each patient. Electrical stimulation parameters may also be selected so as to ablate the nerves, using non-thermal irreversible electroporation, or using joule heating wherein a thermal insulator covers substantially all of the thecal sac, thereby shielding the thecal sac from potential heat damage.

Claims

1. A method of treating 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 one or more nerves in said posterior longitudinal ligament and/or posterior annulus fibrosus, wherein the electrical impulses at least partially relieve pain associated with the discogenic back pain without producing significant heat-damage to any tissue of the patient, and wherein at least one of the one or more nerves experiences non-thermal, irreversible electroporation.

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

3. The method of claim 2 wherein the electrical impulses are not transmitted substantially to a thecal sac and/or to a spinal nerve root.

4. The method of claim 2 wherein the electrodes are disposed substantially linearly along an electrically insulating material, and wherein the electrodes and insulating material are configured to be positioned within the patient percutaneously.

5. The method of claim 4 wherein the electrically insulating material has a cross section perpendicular to a longest axis of said electrically insulating material that has a shape that is substantially rectangular or circular.

6. The method of claim 5 wherein a cannula is inserted through a neural foramen and adjacent to the anterior epidural space;

wherein a cross section of a lumen of the cannula perpendicular to a longest axis of the cannula has a shape that is configured to have substantially the same shape as said shape of the electrically insulating material; and

wherein the electrodes and the insulating material are inserted into said lumen of said cannula.

7. The method of claim 4 wherein the 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 insulating material.

8. The method of claim 7 wherein the fins are disposed perpendicularly to said one direction.

9. The method of claim 2 wherein the plurality of electrodes is disposed nonlinearly or linearly along one side of an electrically insulating material;

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

10. The method of claim 9 wherein the insulating material and the plurality of electrodes are positioned to a vicinity of a single intervertebral disc of the patient.

11. The method of claim 9 wherein the insulating material 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.

12. The method of claim 9 wherein a position of the plurality of electrodes is fixed by attaching the insulating material to a tissue of the patient.

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

14. The method of claim 1 wherein each electrode among the plurality of electrodes may be disconnected from the pulse generator.

15. The method of claim 1 wherein an electrical impedance is used to measure the electroporation.

16. The method of claim 1 wherein a field strength is varied within a range between about 30 V/cm and 1000 V/cm.

17. The method of claim 1 wherein a pulse duration is varied.

18. The method claim 1 wherein a total number of pulses is varied.

19. The method of claim 1 wherein the electrical impulses are sufficient to at least partially relieve said pain within 1 hour of the transmitting step.

20. The method of claim 1 wherein the electrical impulses are sufficient to cause one or more nerves in the posterior longitudinal ligament and/or posterior annulus fibrosus to increase a mechanical force threshold above which threshold said nerve generates an action potential.

21. The method of claim 1 wherein the electrical impulses are sufficient to cause one or more sympathetic nerves in the posterior longitudinal ligament and/or posterior annulus fibrosus to suppress a transmission of an action potential originating in one or more nociceptive nerves in the posterior longitudinal ligament and/or the posterior annulus fibrosus;

and/or to cause a decreased enhancement by one or more sympathetic nerves in the posterior longitudinal ligament and/or the posterior annulus fibrosus of a transmission of an action potential originating in one or more nociceptive nerves in the posterior longitudinal ligament and/or the posterior annulus fibrosus.

22. The method of claim 1 wherein the electrical impulses are sufficient to cause one or more nerves in the posterior longitudinal ligament and/or the posterior annulus fibrosus to decrease a content in said nerve of substance P and/or vasoactive-intestinal peptide and/or calcitonin-gene-related peptide.

23. The method of claim 1 wherein a duration of time between pulses is varied.

24. The method of claim 1 wherein the electrical impulses produce an electric field greater than 680 volts per cm, wherein the electrical pulse duration is between about 0.5 to 10 milliseconds, and wherein the time between pulses is about 10 seconds.

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

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

wherein the plurality of electrodes is 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 said electrical impulses are configured to at least partially relieve pain that is associated with one or more nerves located in the posterior longitudinal ligament and/or the posterior annulus fibrosus without producing significant heat-damage to any tissue of the patient, and wherein the electrical impulses are configured to produce non-thermal, irreversible electroporation in at least one of the one or more nerves.

26. The device of claim 25 further comprising a flexible and/or elastic electrically insulating material having a first side and an opposing second side, wherein said electrodes are attached to said insulating material, and wherein said electrodes are disposed along the first side of said electrically insulating material.

27. The device of claim 26, wherein the electrical impulses are transmitted through said electrodes substantially in one direction.

28. The device of claim 27, wherein the electrodes are disposed substantially linearly along the electrically insulating material, and wherein the electrodes and the insulating material are configured to be inserted into the patient percutaneously through a neural foramen.

29. The device of claim 28 further comprising fins, wherein said fins are joined to the insulating material.

30. The device of claim 27 wherein the plurality of electrodes is disposed nonlinearly or linearly along the first side of the electrically insulating material, and wherein a length, and/or a width, and/or a perimeter of said insulating material is configured to fit within a selected dimension and/or a selected surface area of one or more lumbar discs of the patient and/or to fit within a selected dimension and/or a selected surface area of an intervening vertebral bodies of said discs of the patient, and/or to fit within a selected distance between two adjacent ipsilateral nerve roots of the patient.

31. The device of claim 30 wherein the length, and/or width, and/or perimeter of said insulating material is configured to fit within the selected dimension and/or surface area of a single intervertebral disc of the patient.

32. The device of claim 30 wherein the length, and/or width, and/or perimeter of said insulating material is configured to fit within the selected dimension and/or surface area of two or more intervertebral discs of the patient and/or of the selected dimension and/or surface area of the intervening vertebral bodies of said discs.

33. The device of claim 26 wherein the insulating material is connected to one or more anchoring tabs that are configured for the attachment of said tabs to a tissue of the patient.

34. The device of claim 25 wherein the plurality of electrodes is coupled to the electrical pulse generator with electrically conducting wires.

35. The device of claim 25 wherein the electrical pulse generator is configured to be implanted within the patient.

36. The device of claim 25 wherein power is supplied to the electrical pulse generator by batteries.

37. The device of claim 25 wherein power is supplied to the electrical pulse generator by a receiver that is inductively coupled by a receiving coil to a physically-unattached external transmitter.

38. The device of claim 25 wherein the electrical impulses comprise rectangular, biphasic, charge-balanced pulses of adjustable rate, adjustable duration and adjustable amplitude for each electrode among the plurality of electrodes.

39. The device of claim 25 wherein each electrode among the plurality of electrodes is configured to be disconnectable from the pulse generator.

40. The device of claim 25 wherein an adjustment of each electrode'"'"'s electrical impulse rate, duration, amplitude and anode/cathode configuration, and of each electrode'"'"'s connection or disconnection to the pulse generator, is made by the pulse generator using control signals that are transmitted to the pulse generator by a programmer.

41. The device of claim 40 wherein the transmission of the control signals is to a receiver of the pulse generator, said receiver being inductively coupled by a receiving coil to a physically unattached external transmitter of the programmer.

42. The device of claim 25 that is configured to measure the electroporation using an electrical impedance.

43. The device of claim 25 that is configured to vary a field strength within a range between about 30 V/cm and 1000 V/cm.

44. The device of claim 25 that is configured to vary a pulse duration.

45. The device of claim 25 that is configured to vary a total number of pulses.

46. The device of claim 25 that is configured to vary a duration of time between pulses.

47. The device of claim 25 wherein the electrical impulses are configured to generate an electric field that is greater than 680 volts per cm, and wherein the electrical pulse duration is configured to be between about 0.5 to 10 milliseconds.

48. 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.