METHOD AND SYSTEM FOR CONTROLLED NERVE ABLATION

• US 20100016929A1
• Filed: 09/23/2009
• Published: 01/21/2010
• Est. Priority Date: 01/22/2004
• Status: Abandoned Application

• Current Assignee: Rehabtronics, Inc.
• Original Assignee: Rehabtronics, Inc.
• Inventors: Prochazka, Arthur
• Application Number:
  US12/565,377
• Publication Number:
  US 20100016929A1
• Time in Patent Office: Days
• US Class Current: 607/72
• CPC Class Codes: A61B 5/0028 Body tissue as transmission medium, i.e. transmission systems where the medium is the human body
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/20 continuous direct currents
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

The invention provides a system and method for treating a subject having unwanted or overactive nerve activity. The method involves applying one or more of direct current, charge imbalanced time varying current and pulsatile current to a target nerve; and controlling the amplitude and the duration of the current such that there is a net charge delivered to the target nerve at a sufficient charge density to cause controlled ablation to the target nerve until unwanted or overactive nerve activity is reduced in one or both of the target nerve and a target body tissue innervated by the target nerve.

Claims

1. A method of treating a subject having unwanted or overactive nerve activity, comprising:

(a) applying one or more of direct current and charge imbalanced time varying current to a target nerve; and

(b) controlling the amplitude and the duration of the current such that there is a net charge delivered to the target nerve at a sufficient current density to cause controlled ablation of the target nerve until unwanted or overactive nerve activity is reduced in one or both of the target nerve and a target body tissue innervated by the target nerve.

2. The method of claim 1, wherein the current is direct current delivered to the target nerve at a current density of between 0.2 mA/cm² and 12 mA/cm².

3. The method of claim 2, wherein the current is applied for a duration of more than 10 seconds.

4. The method of claim 1, wherein the nerve is a peripheral nerve.

5. The method of claim 1, wherein the current is delivered while the subject is sedated or anesthetized.

6. The method of claim 1, wherein the current is delivered as charge imbalanced pulsatile current.

7. The method of claim 1, wherein the current is delivered to the nerve through an implanted conductor having a delivery portion positioned proximate to, or attached to, the target nerve.

8. The method of claim 7, wherein the current is delivered to the nerve with an implanted current source connected to the implanted conductor.

9. The method of claim 8, wherein the implanted current source is controlled by an external controller which is inductively coupled through the subject'"'"'s skin to the implanted current source.

10. The method of claim 7, which further comprises, upon recovery of the ablated nerve and re-innervation of the target body tissue re-applying the current as in steps (a) and (b).

11. The method of claim 8, wherein the target nerve is one or more of a facial nerve, a spinal accessory nerve, a musculocutaneous nerve, a median nerve, a pudendal nerve, a sciatic nerve, a femoral nerve, and one or more branches of one of these target nerves.

20. The method of claim 1, which further comprises providing a second implant beneath the subject'"'"'s skin positioned to provide a return path for the current between the target nerve and the second surface electrode.

22. The method of claim 1, wherein the implant is one implant from a plurality of implants, the method further comprising implanting each implant from the plurality of implants entirely under the subject'"'"'s skin, each of the plurality of implants extending to a different target nerve, and positioning a plurality of surface electrodes on the subject'"'"'s skin relative to the plurality of implants to cause nerve ablation to the different target nerves independently.

12. A method of treating a subject having unwanted or overactive nerve activity, comprising:

(a) implanting an implant under the subject'"'"'s skin, the implant including a passive electrical conductor having a pick-up portion and a delivery portion and being insulated between the pick-up portion and the delivery portion, the pick-up portion being configured to pick up at least a portion of a current flowing between a first surface electrode and a second surface electrode when positioned on the subject'"'"'s skin, and to transmit the portion of the current to a target nerve;

(b) positioning the first surface electrode and the second surface electrode in spaced relationship on the subject'"'"'s skin to make direct electrical contact with the subject'"'"'s skin, with the first surface electrode positioned over the pick-up portion of the electrical conductor so the portion of the current is transmitted through the electrical conductor to the target nerve; and

(c) applying one or more of direct current and charge imbalanced time varying current between the first surface electrode and the second surface electrode to cause the portion of the electrical current to flow through the implant to be delivered to the target nerve; and

(d) controlling the amplitude and the duration of the current such that there is a net charge delivered to the target nerve at a sufficient current density to cause controlled ablation of the target nerve until unwanted or overactive nerve activity is reduced in one or both of the target nerve and a target body tissue innervated by the target nerve.

13. The method of claim 12, wherein the current is direct current delivered such that the portion of current which flows through the implant is at a current density of between 0.2 mA/cm² and 12 mA/cm².

14. The method of claim 13, wherein the current is applied for a duration of more than 10 seconds.

15. The method of claim 12, wherein the nerve is a peripheral nerve.

16. The method of claim 12, wherein the current is delivered while the subject is sedated or anesthetized.

17. The method of claim 12, wherein the current is delivered as charge imbalanced pulsatile current.

18. The method of claim 12, which further comprises, upon recovery of the target nerve and re-innervation of the target body tissue, re-applying the current as in steps (a) and (b).

19. The method of claim 16, wherein the target nerve is one or more of a facial nerve, a spinal accessory nerve, a musculocutaneous nerve, a median nerve, a pudendal nerve, a sciatic nerve, a femoral nerve, and one or more branches of one of these target nerves.

21. The method of claim 12, which further comprises providing a second implant beneath the subject'"'"'s skin positioned to provide a return path for the electrical current between the target nerve and the second surface electrode.

23. The method of claim 12, wherein the implant is one implant from a plurality of implants, the method further comprising implanting each implant from the plurality of implants entirely under the subject'"'"'s skin, each of the plurality of implants extending to a different target nerve, and positioning a plurality of surface electrodes on the subject'"'"'s skin relative to the plurality of implants to cause nerve ablation to the different target nerves independently.

24. A system for treating a subject, comprising:

an implant including an insulated electrical conductor having a delivery portion configured to deliver current to a target nerve; and

a current source configured to supply current in the form of one or more of direct current and charge imbalanced time varying current to the implant, and being configured to control the amplitude and the duration of the current such that a net charge may be delivered to the target nerve at a sufficient current density to cause controlled ablation of the target nerve.

25. The system of claim 24, wherein the delivery portion of the implant includes an electrical termination configured to deliver current to the target nerve at a current density of between 0.2 mA/cm² and 12 mA/cm².

26. The system of claim 25, wherein the current source is configured to be implanted beneath the subject'"'"'s skin, and wherein the system further comprises an external controller configured to be inductively coupled through the subject'"'"'s skin to the implanted current source in order to control the amplitude and the duration of the current delivered to the target nerve.

27. A system for treating a subject, comprising:

a first surface electrode and a second surface electrode configured to make electrical contact with the subject'"'"'s skin and to transmit current to bodily tissue below the skin;

a stimulator electrically coupled to the first surface electrode and the second surface electrode, the stimulator being configured to supply current to the first surface electrode and the second surface electrode in the form of one or more of direct current and charge imbalanced time varying current, and the stimulator being configured with controls for the amplitude and the duration of the current such that a net charge may be delivered to a target nerve at a sufficient current density to cause controlled ablation of the target nerve;

an implant including a passive electrical conductor having a pick-up portion and a delivery portion and being insulated between the pick-up portion and the delivery portion, the pick-up portion being configured so that, once implanted beneath the skin, the pick-up portion picks up at least a portion of a current flowing between the first surface electrode and the second surface electrode when positioned on the subject'"'"'s skin, and transmits the portion of the current to the target nerve.

28. The system of claim 27, wherein the stimulator is adapted to deliver direct current such that current is delivered to the target nerve at a current density of between 0.2 mA/cm² and 12 mA/cm², and wherein the delivery portion of the implant includes an electrical termination configured to deliver current to the target nerve at these current densities.

29. The system of claim 27, wherein the stimulator is adapted to deliver charge imbalanced pulsatile current to the target nerve.

30. The system of claim 28, wherein;

the pick-up portion forms an electrical termination having a sufficient surface area such that, once implanted in subcutaneous tissue below the first surface electrode, the portion of the current flows through the conductor, in preference to flowing through bodily tissue between the first surface electrode and the second surface electrode; and

the delivery portion forms an electrical termination to deliver the portion of the current to the target nerve, once implanted.

31. The system of claim 28, wherein:

the electrical termination at one or both of the pick-up portion and the delivery portion is formed from the uninsulated end of the conductor, or from other conductive or capacitive materials.

32. The system of claim 28, wherein the stimulator is configured to be external to the subject'"'"'s body.

33. The system of claim 28, wherein at least the pick-up portion or the delivery portion is configured to include an enlarged surface area in the form of at least one of a coil, a spiral, a cuff, a rod, or a plate or a sheet in the form of an oval or a polygon.

34. The system of claim 28, wherein at least one of the pick-up portion or the delivery portion is formed from at least one of an uninsulated end of the conductor or from other conductive or capacitive materials.

35. The system of claim 28, further comprising:

an electrical return conductor having a collecting portion, a returning portion and an insulated portion between the collecting portion and the returning portion;

the collecting portion configured to collect a portion of the current delivered to the target nerve to return through the electrical return conductor in preference to returning through bodily tissue; and

the returning portion forming an electrical termination that returns the portion of the current to the second surface electrode via subcutaneous tissue and skin underlying the second surface electrode.

36. The system of claim 28, wherein the conductor is formed from at least one of a metal wire, carbon fibers, a conductive rubber or other conductive polymer, or a conductive salt solution in rubber.

37. The system of claim 28, wherein the first surface electrode and the second surface electrode include a conductive plate or a conductive sheet, a conductive gel electrode, a conductive rubber or polymer electrode that may be partially coated with an electrode paste or gel, or a moistened absorbent pad electrode.

38. The system of claim 28, further comprising a coating on one of both of the pick-up portion or the delivery portion, the coating being at least one of a conductive coating or capacitive coating, an oxide layer, an anti-inflammatory agent, an antibacterial agent, an antibiotic, or a tissue ingrowth promoter.

39. The system of claim 28, wherein the implant is one implant from a plurality of implants, each implant from the plurality of implants being configured to be implanted entirely under a subject'"'"'s skin, each of the plurality of implants being of a sufficient length to extend to a different target nerve, the first surface electrode being one of a plurality of first surface electrodes and at least the first surface electrode and the second surface electrode being configured to be positioned relative to the plurality of implants to cause controlled ablation of a different target nerve independently.

40. The system of claim 28, wherein the pick-up portion is configured to pick up the portion of the electrical current via resistive coupling.

41. The system of claim 28, wherein the pick-up portion is configured to pick up the portion of the electrical current via capacitive and resistive coupling.