SYSTEMS AND METHODS FOR NEUROMODULATION FOR TREATMENT OF PAIN AND OTHER DISORDERS ASSOCIATED WITH NERVE CONDUCTION

• US 20070021803A1
• Filed: 07/24/2006
• Published: 01/25/2007
• Est. Priority Date: 07/22/2005
• Status: Abandoned Application

• Current Assignee: Ardian, Inc. (Medtronic Plc)
• Original Assignee: The Foundry Inc.
• Inventors: Gifford, Hanson, DEEM, MARK
• Application Number:
  US11/459,582
• Publication Number:
  US 20070021803A1
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61N 1/0412 Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36071 Pain

Abstract

Methods and apparatus are provided for selective destruction or temporary disruption of nerves and/or conduction pathways in a mammalian body for the treatment of pain and other disorders. Apparatus comprises catheters having electrodes for targeting and affecting nerve tissue at a cellular level to reversible and irreversible nerve poration and incapacitation.

Claims

1. Apparatus for selective denervation of target tissue, comprising:

an electrode support having one or more electrodes disposed thereon, wherein said electrode(s) are adapted to transmit an electrical pulse and/or series of electrical pulses; and

a pulse generator operatively connected to the catheter, wherein the electrodes and generator are configured to deliver cellular poration energy in the range from 10 V/cm to 10⁶ V/cm to disrupt membranes of target cells to disrupt pain conduction pathways.

2. The apparatus of claim 1, wherein the support comprises a catheter which is adapted to be positioned percutaneously in an artery at a location adjacent to a region of the spine in a human patient selected from the group consisting of the cervical, thoracic, sacral and lumbar regions.

3. The apparatus of claim 1, wherein the support comprises a catheter which is adapted to be positioned percutaneously at a region of the peripheral nerves in a human patient.

4. The apparatus of claim 1, wherein the support comprises a catheter which is adapted to be implantable within the body and a pulse generator adapted to be located outside the human body.

5. The apparatus of claim 1, wherein the support and pulse generator are implantable within the human body.

6. The apparatus of claim 1, wherein the support comprises a patch and the one or more electrodes are configured on the patch to be applied to the skin.

7. The apparatus of claim 6, wherein the one or more electrodes comprise one or more micro needles.

8. The apparatus of claim 1, wherein the pulse generator and electrodes are adapted to deliver poration energy at from 10 V/cm to 10⁴ V/cm for durations from 10 μ

sec to 100 msec to achieve reversible poration.

9. The apparatus of claim 1, wherein the pulse generator and electrodes are adapted to deliver poration energy at from 100 V/cm to 10⁶ V/cm for durations from 10 μ

sec to 100 msec to achieve irreversible poration.

10. A method for selective denervation of targeted tissue of a patient, said method comprising delivering energy to target cells of said target tissue under conditions selected to permeabilize the cell membrane to disrupt a pain conduction pathway provided by the cell.

11. A method as in claim 10, wherein the target cells are nerve cells.

12. A method as in claim 11, wherein the nerve cells are selected from the group consisting of nerves of the spine, peripheral nerves, nerves of the head and neck, and the brain stem.

13. A method as in claim 12, wherein the nerve cells are in the spine.

14. A method as in claim 13, wherein the target spinal nerve cells are in the region of the sacral plexus.

15. A method as in claim 13, wherein the target spinal nerve cells comprise those in the stellate ganglion in the region of C6.

16. A method as in claim 12, wherein the target spinal nerve cells are in the area of T6.

17. A method as in claim 11, wherein the nerve cells are immediately adjacent to an artery.

18. A method as in claim 17, wherein said energy is delivered from a catheter positioned in the artery.

19. A method as in claim 10, wherein the energy is electric delivered in the range from 10 V/cm to 10⁶ V/cm for a period in the range from 10 μ

sec to 100 msec.

20. A method as in claim 10, wherein the energy is delivered under conditions which provide a reversible poration.

21. A method as in claim 20, wherein the energy is electrical in the range from 10 V/cm to 10⁴ V/cm.

22. A method as in claim 10, wherein the energy id delivered under conditions which provide an irreversible poration.

23. A method as in claim 22, wherein the energy is electrical in the range from 100 V/cm to 10⁶ V/cm.

24. A method as in claim 10, wherein the energy comprises ultrasonic energy.

25. A method as in claim 10, further comprising delivering a nerve blocking agent under conditions to act together with the energy to block the pain conduction pathway.

26. A method as in claim 25, wherein the nerve blocking agent is delivered simultaneously with the energy delivery.

27. A method as in claim 10, wherein the energy is delivered with a catheter.

28. A method as in claim 27, wherein the catheter is implanted.

29. A method as in claim 27, wherein the catheter is percutaneously positioned in an artery.

30. A method as in claim 10, wherein the energy is delivered transcutaneously from a surface of the patient'"'"'s skin.