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

• US 20100010567A1
• Filed: 09/25/2009
• Published: 01/14/2010
• Est. Priority Date: 07/22/2005
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: The Foundry Inc.
• Inventors: Deem, Mark E., Gifford, Hanson
• Granted Patent: US 8,504,147 B2
• 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. An apparatus for selective denervation of a target tissue in a patient'"'"'s body, the target tissue comprising nerve cells, the apparatus comprising:

a non-implantable intraluminal catheter adapted to be percutaneously introduced into a lumen of an artery, the catheter having one or more electrodes disposed thereon, wherein said electrode(s) are adapted to transmit at least one of an electrical pulse or a 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 nerve cells outside the lumen of the artery to disrupt a pain conduction pathway by inducing apoptosis of the nerve cells, wherein the pulse generator is electrically connected to a proximal end of the intraluminal catheter outside the patient'"'"'s body to deliver cellular poration energy to the one or more electrodes when the catheter is percutaneously introduced into the lumen of the artery.

2. The apparatus of claim 1, wherein the catheter is adapted to be positioned percutaneously in an artery to position said electrode(s) at a location adjacent to a region of a spine in a human patient selected from the group consisting of a cervical region, a thoracic region, a sacral region and a lumbar region.

3. The apparatus of claim 1, wherein the catheter is adapted to be positioned percutaneously in an artery to position said electrode(s) at a region of peripheral nerves in a human patient.

4. 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.

5. 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.

6. An apparatus for selective denervation of a target tissue, the target tissue comprising nerve cells having membranes, the apparatus comprising:

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

a pulse generator operatively connected to the electrode support, wherein the electrodes and generator are configured to deliver cellular poration energy in the range from 10 V/cm to 10⁶ V/cm for durations from 10 μ

sec to 100 msec to disrupt a pain conduction pathway by disrupting target-tissue nerve-cell membranes,

wherein the support comprises a patch and the one or more electrodes are configured on the patch to be applied to a skin.

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

8. A method for selective denervation of a targeted tissue of a patient, said method comprising delivering energy to target nerve cells of said target tissue under conditions selected to disrupt a pain conduction pathway-by permeabilizing a cell membrane of said target nerve cells.

9. A method as in claim 8, wherein the target cells are nerve cells.

10. A method as in claim 9, wherein the nerve cells are selected from the group consisting of nerves of a spine, peripheral nerves, nerves of a head and neck, and a brain stem.

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

12. A method as in claim 11, wherein the target spinal nerve cells are in a region of a sacral plexus.

13. A method as in claim 11, wherein the target spinal nerve cells comprise those in a stellate ganglion in the region of C6.

14. A method as in claim 10, wherein the target spinal nerve cells are in an area of T6.

15. A method as in claim 9, wherein the nerve cells are outside a lumen of an artery and the energy is delivered from within the lumen of the artery.

16. A method as in claim 15, wherein said energy is delivered from a catheter transluminally positioned in the artery.

17. A method as in claim 8, 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.

18. A method as in claim 8, wherein the energy is delivered under conditions which provide a reversible poration.

19. A method as in claim 18, wherein the energy is electrical in the range from 10 V/cm to 10⁴ V/cm.

20. A method as in claim 8, wherein the energy is delivered under conditions which provide an irreversible poration.