Method of routing electrical current to bodily tissues via implanted passive conductors

• US 9,072,886 B2
• Filed: 02/14/2014
• Issued: 07/07/2015
• Est. Priority Date: 01/22/2004
• Status: Active Grant

• Current Assignee: 2249020 Alberta Limited
• Original Assignee: Rehabtronics, Inc.
• Inventors: Gaunt, Robert Andrew, Prochazka, Arthur
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US14/180,972
• Publication Number:
  US 20140316497A1
• Time in Patent Office: 508 Days
• Field of Search: 607/46, 607/48, 607/50, 607/75, 607/148
• US Class Current: 1/1
• 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: A61B 5/4029 for evaluating the peripheral nervous systems A61B5/24 takes precedence
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61N 1/0472 Structure-related aspects
• 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 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• 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

The invention provides an implant, system and method for electrically stimulating a target tissue to either activate or block neural impulses. The implant provides a conductive pathway for a portion of electrical current flowing between surface electrodes positioned on the skin and transmits that current to the target tissue. The implant has a passive electrical conductor of sufficient length to extend from subcutaneous tissue located below a surface cathodic electrode to the target tissue. The conductor has a pick-up end which forms an electrical termination having a sufficient surface area to allow a sufficient portion of the electrical current to flow through the conductor, in preference to flowing through body tissue between the surface electrodes, such that the target tissue is stimulated to either activate or block neural impulses. The conductor also has a stimulating end which forms an electrical termination for delivering the current to the target body tissue.

Claims

1. A system for electrically stimulating a target body tissue in a subject, comprising:

a surface cathodic electrode and a surface anodic electrode configured to make electrical contact with the subject'"'"'s skin and to transmit electrical current when positioned in a spaced relationship on the subject'"'"'s skin;

a stimulator external to the subject'"'"'s body, electrically connected to the surface cathodic electrode and the surface anodic electrode, the stimulator being configured to supply direct, pulsatile, or alternating current to the surface cathodic electrode and the surface anodic electrode at a frequency from 1 Hz to 30 kHz; and

an implant configured to pick up a portion of the electrical current flowing between the surface cathodic electrode and the surface anodic electrode and to transmit the portion of the electrical current to the target body tissue, the implant comprising a passive electrical conductor of sufficient length to extend, once implanted, from subcutaneous tissue located below the surface cathodic electrode to the target body tissue, the electrical conductor having a pick-up portion and a stimulating portion and being insulated between its pick-up portion and its stimulating portion, the pick-up portion forming an electrical termination having a sufficient surface area to allow a portion of the electrical current to flow through the conductor, in preference to flowing through body tissue between the surface cathodic and anodic electrodes, and the stimulating portion forming an electrical termination for delivering the portion of electrical current to the target body tissue.

2. The system of claim 1, further comprising an electrical return conductor of sufficient length to extend, once implanted, from the target body tissue to subcutaneous tissue located below the surface anodic electrode, the return conductor having a collecting portion and a returning portion and being insulated between its collecting portion and its returning portion, the collecting portion forming an electrical termination having a sufficient surface area to allow a portion of the current delivered to the target body tissue to return through the return conductor in preference to returning through body tissue, and the returning portion forming an electrical termination to return the electrical current to the surface anodic electrode via the subcutaneous tissue and skin underlying the surface anodic electrode.

3. The system of claim 2, wherein at least one of the conductor and the return conductor is formed from a metal wire, carbon fibers, a conductive rubber or other conductive polymer, or a conductive salt solution in rubber.

4. The system of claim 1, wherein the termination on at least one of the pick-up portion or the stimulating portion is an enlarged surface in the form of a coil, a spiral, a cuff, a rod, or a plate or sheet in the form of an oval or polygon.

5. The system of claim 1, wherein the surface cathodic and anodic electrodes each comprise a conductive plate or 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.

6. The system of claim 1, wherein the terminations of the pick-up and delivery portions are formed from uninsulated end portions of the conductor itself or from other conductive materials.

7. The system of claim 1, further comprising a coating on at least one of the terminations, the coating being a conductive or capacitive coating, an oxide layer, an anti-inflammatory agent, an antibacterial agent, an antibiotic, or a tissue ingrowth promoter.

8. The system of claim 1, wherein the stimulator is configured to supply electrical current in the form of a cyclical monophasic wave form or in the form of a cyclical biphasic waveform.

9. The system of claim 1, wherein:

the implant is one implant from a plurality of implants, each of the plurality of implants configured to electrically block target body tissue independently or in unison, each implant from the plurality of implants configured to be implanted entirely under the subject'"'"'s skin and to be of a sufficient length to extend to a different target body tissue, and

the surface cathodic electrode is one surface cathodic electrode from a plurality of surface cathodic electrodes, at least the surface cathodic electrode and the surface anodic electrode configured to be positioned relative to the plurality of implants to block the different target body tissues independently or in unison.

10. The system of claim 1, wherein:

the implant is one implant from a plurality of implants, each of the plurality of implants configured to electrically activate target body tissue independently or in unison, each implant from the plurality of implants configured to be implanted entirely under the subject'"'"'s skin and to be of a sufficient length to extend to a different target body tissue, and

the surface cathodic electrode is one surface cathodic electrode from a plurality of surface cathodic electrodes, at least the surface cathodic electrode and the surface anodic electrode configured to be positioned relative to the plurality of implants to activate the different target body tissues independently or in unison.

11. A method comprising at least one of electrically blocking or electrically activating a target body tissue in a subject using the system of claim 1.

12. The system of claim 1, wherein the stimulator is configured to supply electrical current in the form of a cyclical waveform at a frequency in the range of from 100 Hz to 20 kHz for blocking the target body tissue.

13. The system of claim 1, wherein the stimulator is configured to supply electrical current in the form of a cyclical waveform at a frequency in the range of from 100 Hz to 10 kHz for blocking the target body tissue.

14. The system of claim 1, wherein the stimulator is configured to supply electrical current in the form of a cyclical waveform at a frequency in the range of from 200 Hz to 5 kHz for blocking the target body tissue.

15. The system of claim 1, wherein the stimulator is configured to supply electrical current in the form of a cyclical waveform at a frequency in the range of from 1 kHz to 30 kHz for blocking the target body tissue.

16. The system of claim 1, wherein the stimulator is configured to supply electrical current in the form of a cyclical waveform at a frequency in the range of from 1 kHz to 20 kHz for blocking the target body tissue.

17. The system of claim 1, wherein the stimulator is configured to supply electrical current in the form of a cyclical waveform at a frequency in the range of from 1 kHz to 10 kHz for blocking the target body tissue.

18. The system of claim 1, wherein the stimulator is configured to supply electrical current at a frequency in the range of from 1 Hz to 100 Hz for activating the target body tissue.

19. The system of claim 1, wherein the stimulator is configured to supply electrical current at a frequency in the range of from 1 Hz to 50 Hz for activating the target body tissue.

20. The system of claim 1, wherein the stimulator is configured to supply electrical current at a frequency in the range of from 1 Hz to 20 Hz for activating the target body tissue.

21. The system of claim 1, wherein the stimulator is configured to supply electrical current in the form of a cyclical waveform at a frequency in the range of from 100 Hz to 30 kHz for blocking the target body tissue.

22. The system of claim 21, wherein the stimulator is configured to supply electrical current in a cyclical waveform selected from alternating current, pulsatile, sinusoidal, triangular, rectangular and sawtooth waveforms.

23. A method of treating a disorder by electrically stimulating a target body tissue in a subject, comprising:

implanting an implant entirely under the subject'"'"'s skin, the implant configured to act as a conductive pathway for at least a portion of an electrical current flowing between a surface cathodic electrode and a surface anodic electrode positioned in a spaced relationship on the subject'"'"'s skin and to transmit the portion of the electrical current to the target body tissue, the implant comprising a passive electrical conductor of sufficient length to extend, once implanted, from subcutaneous tissue located below the surface cathodic electrode to the target body tissue, the electrical conductor having a pick-up portion and a stimulating portion and being insulated between its pick-up portion and its stimulating portion, the pick-up portion forming an electrical termination having a sufficient surface area to allow a portion of the electrical current to flow through the conductor, in preference to flowing through body tissue between the surface cathodic electrode and the surface anodic electrode, such that the target body tissue is stimulated, and the stimulating portion forming an electrical termination to deliver the portion of electrical current to the target body tissue, the implant being implanted such that the pick-up portion is positioned in subcutaneous tissue located below the surface cathodic electrode and the stimulating portion is positioned proximate to the target body tissue;

positioning the surface cathodic and anodic electrodes in a spaced relationship on the subject'"'"'s skin to make electrical contact with the skin, the surface cathodic electrode being positioned over the pick-up portion of the electrical conductor such that the portion of the electrical current is transmitted through the conductor to the target body tissue, and such that the electrical current flows through the target body tissue and returns to the anodic surface electrode through body tissues or through an implanted electrical return conductor extending between the target body tissue and subcutaneous tissue located below the surface anodic electrode; and

applying electrical current in at least one of a direct, pulsatile, or alternating current to at least one of the surface cathodic electrode and the surface anodic electrode, the electrical current being supplied by a stimulator external to the subject'"'"'s body and electrically connected to the surface cathodic and anodic electrodes, the electrical current being applied at a frequency within the range of from 1 Hz to 30 kHz for stimulating the target body tissue.

24. The method according to claim 23, further comprising implanting an electrical return conductor entirely under the subject'"'"'s skin, the return conductor being of sufficient length to extend, once implanted, from the target tissue to subcutaneous tissue located below the surface anodic electrode, the return conductor having a collecting portion and a returning portion and being insulated between its collecting portion and its returning portion, the collecting portion forming an electrical termination having a sufficient surface area to allow a portion of the electrical current delivered to the target body tissue to return through the return conductor in preference to returning through body tissue, and the returning portion forming an electrical termination to return the electrical current to the surface anodic electrode via the subcutaneous tissue and skin underlying the surface anodic electrode.

25. The method of claim 23, wherein electrical current is supplied at a frequency in the range of from 100 Hz to 30 kHz for blocking the target body tissue.

26. The method of claim 25, wherein the disorder is one or more of urinary retention, incontinence, pain, an autonomic disorder, spasticity, tremor, muscle weakness, Parkinson'"'"'s disease, and dystonia.

27. The method of claim 26, wherein the body tissue is selected from a neural tissue in the peripheral or central nervous system or a nerve.

28. The method of claim 27, wherein the electrical current is supplied at a frequency in the range of from 100 Hz to 20 kHz.

29. The method of claim 27, wherein the electrical current is supplied at a frequency in the range of from 100 Hz to 10 kHz.

30. The method of claim 27, wherein the electrical current is supplied at a frequency in the range of from 200 Hz to 5 kHz.

31. The method of claim 27, wherein the electrical current is supplied at a frequency in the range of from 1 kHz to 30 kHz.

32. The method of claim 27, wherein the electrical current is supplied at a frequency in the range of from 1 kHz to 20 kHz.

33. The method of claim 27, wherein the electrical current is supplied at a frequency in the range of from 1 kHz to 10 kHz.

34. The method of claim 27, wherein the stimulator is configured to supply electrical current in a cyclical monophasic waveform or in a cyclical biphasic waveform.

35. The method of claim 27, wherein the implant is one implant from a plurality of implants, each of the plurality of implants configured to be implanted entirely under the subject'"'"'s skin and being of a sufficient length to extend to a different target body tissue, and the surface cathodic electrode is one of a plurality of surface cathodic electrodes, the plurality of implants, the plurality of surface cathodic electrodes and the surface anodic electrode being collectively configured to electrically block more than one target body tissue independently or in unison, further comprising:

positioning the plurality of surface cathodic electrodes and the surface anodic electrode on the subject'"'"'s skin relative to the plurality of implants implanted entirely beneath the subject'"'"'s skin; and

supplying the electrical current to block the more than one target body tissue independently or in unison.

36. The method of claim 23, wherein the electrical current is applied at a frequency in the range of from 1 Hz to 100 Hz for activating the target tissue.

37. The method of claim 36, wherein the body tissue is selected from a neural tissue in the peripheral or central nervous system or a nerve.

38. The method of claim 36, wherein the electrical current is applied at a frequency in the range of from 1 Hz to 50 Hz.

39. The method of claim 36, wherein the implant is one implant from a plurality of implants, each of the plurality of implants configured to be implanted entirely under the subject'"'"'s skin and being of a sufficient length to extend to a different target body tissue, and the surface cathodic electrode is one of a plurality of surface cathodic electrodes, the plurality of implants, the plurality of surface cathodic electrodes and the surface anodic electrode being collectively configured to electrically activate more than one target body tissue independently or in unison, further comprising:

positioning the plurality of surface cathodic electrodes and the surface anodic electrode on the subject'"'"'s skin relative to the plurality of implants implanted entirely beneath the subject'"'"'s skin; and

supplying the electrical current to activate the more than one target body tissue independently or in unison.