Implant system and method using implanted passive conductors for routing electrical current

• US 8,332,029 B2
• Filed: 06/28/2006
• Issued: 12/11/2012
• Est. Priority Date: 06/28/2005
• Status: Active Grant

• Current Assignee: Bioness Inc. (Smith & Nephew PLC)
• Original Assignee: Bioness Inc. (Smith & Nephew PLC)
• Inventors: Glukhovsky, Arkady, Zilberman, Yitzhak, Chamberlain, Mark, Davis, Ross, Schulman, Joseph, Prochazka, Arthur
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): Wieland, Robert N
• Application Number:
  US11/993,393
• Publication Number:
  US 20100198298A1
• Time in Patent Office: 2,358 Days
• Field of Search: 607/2, 607/3, 607/41, 607/48
• US Class Current: 607/2
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• 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 1/36017 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 present invention provides improvements to an implant, system and method using passive electrical conductors which route electrical current to either external or implanted electrical devices, to multiple target body tissues and to selective target body tissues. The passive electrical conductor extends from subcutaneous tissue located below either a surface cathodic electrode or a surface anodic electrode a) to a target tissue to route electrical signals from the target body tissue to devices external to the body; b) to implanted electrical devices to deliver electrical current to such devices, or c) to multiple target body tissues or to selective target body tissues to stimulate the target body tissues. The conductor has specialized ends for achieving such purposes.

Claims

1. An apparatus, comprising:

a passive electrical conductor having a first end portion and a second end portion, the first end portion including a stimulation electrode, the second end portion including a pick-up electrode, the passive electrical conductor configured to be disposed within a body such that the stimulation electrode is disposed adjacent a target tissue and the pick-up electrode is entirely beneath a surface of a skin; and

an insulating backing coupled to the second end portion of the passive electrical conductor, the insulating backing configured to define, at least in part, a current pathway within the body along which a portion of an electrical current flows between a surface electrode coupled to the surface of the skin and the pick-up electrode.

2. The apparatus of claim 1, wherein the passive electrical conductor is insulated between the first end portion and the second end portion.

3. The apparatus of claim 1, wherein the insulating backing is constructed from any one of silicone and polyester.

4. The apparatus of claim 1, wherein the insulating backing is configured to inhibit the flow of the electrical current through a portion of a subcutaneous tissue.

5. The apparatus of claim 1, wherein the insulating backing is configured to limit flow of the electrical current from the surface electrode to a bodily tissue beneath the insulating backing.

6. The apparatus of claim 1, wherein at least a portion of the insulating backing is disposed about a periphery of the pick-up electrode.

7. The apparatus of claim 1, wherein:

the pick-up electrode is a first pick-up electrode from a plurality of pick-up electrodes; and

the current pathway is defined, at least in part, by the insulating backing a portion of the electrical current flows between the surface electrode and a second pick-up electrode of the plurality of pick-up electrodes.

8. The apparatus of claim 1, wherein at least a portion of the pick-up electrode has a coil shape.

9. The apparatus of claim 1, wherein the stimulation electrode is a stimulation electrode from a plurality of stimulation electrodes.

10. The apparatus of claim 1, wherein a surface area of the stimulation electrode is less than approximately 50 square millimeters.

11. The apparatus of claim 1, wherein a surface area of the stimulation electrode is between approximately 10 square millimeters and approximately 50 square millimeters.

12. The apparatus of claim 1, wherein:

the pick-up electrode is a pick-up electrode from a plurality of pick-up electrodes; and

the stimulation electrode is a stimulation electrode from a plurality of stimulation electrodes, each stimulation electrode from the plurality of stimulation electrodes being electronically coupled to a corresponding pick-up electrode from the plurality of pick-up electrodes.

13. The apparatus of claim 1, further comprising:

an anchor coupled to the first end portion of the passive electrical conductor, the anchor configured to limit movement of the stimulation electrode relative to the target tissue when the passive electrical conductor is disposed within the body.

14. A system, comprising:

an electronic device configured to be disposed outside of a body, the electronic device configured to at least produce or receive an electrical signal;

an electrode configured to be electrically coupled to the electronic device, the electrode configured to be coupled to the surface of a skin of the body; and

an electrically conductive member configured to be disposed entirely within the body such that a proximal end portion of the electrically conductive member is disposed below the electrode, the electrically conductive member configured to convey at least a portion of the electrical signal between the proximal end portion and a distal end portion, the proximal end portion of the electrically conductive member including an insulative backing.

15. The system of claim 14, wherein the electronic device includes any one of a stimulator, a signal generator, an amplifier and a switch.

16. The system of claim 14, wherein the distal end portion of the electrically conductive member includes a plurality of stimulation electrodes.

17. The system of claim 14, wherein:

the proximal end portion of the electrically conductive member includes a pick-up electrode having a coiled shape; and

the distal end portion of the electrically conductive member includes a plurality of stimulation electrodes.

18. The apparatus of claim 14, wherein the insulative backing is constructed from any one of silicone and polyester.

19. The apparatus of claim 14, wherein the insulative backing is movably coupled to the proximal end portion of the electrically conductive member.

20. A method, comprising:

inserting a conductive member within a body such that a stimulating electrode disposed at a distal end portion of the conductive member is adjacent a target tissue within the body and a pick-up electrode disposed at a proximal end portion of the conductive member is beneath a surface of a skin of the body; and

positioning at least a portion of an insulative backing relative to the pick-up electrode such that the insulative backing defines, at least in part, a portion of a current pathway through which a current from a surface electrode can be directed from the surface electrode to the pick-up electrode.

21. The method of claim 20, wherein an exterior surface of the conductive member is insulated between the distal end portion and the proximal end portion.

22. The method of claim 20, wherein the positioning includes positioning the insulative backing to limit flow of an electrical current from the surface electrode to a subcutaneous tissue substantially beneath at least one of the insulative backing and the pick-up electrode.

23. The method of claim 20, wherein the insulative backing is coupled to the proximal end portion of the conductive member.

24. The method of claim 20, further comprising:

coupling a surface electrode to the surface of the skin such that at least a portion of the pick-up electrode is below the surface electrode.

25. A method, comprising:

inserting a conductive member within a body such that a stimulating electrode disposed at a distal end portion of the conductive member is adjacent a target tissue within the body and a pick-up electrode disposed at a proximal end portion of the conductive member is beneath a surface of a skin of the body;

coupling a surface electrode to the surface of the skin such that at least a portion of the pick-up electrode is below the surface electrode; and

defining at least a portion of a current pathway within the body such that a portion of an electrical current produced by the surface electrode is directed towards the pick-up electrode.

26. The method of claim 25, wherein:

the conductive member includes a first insulation member disposed about an exterior surface of the conductive member; and

the defining includes moving at least a portion of a second insulation member relative to the proximal end portion of the conductive member after the inserting.

27. The method of claim 25, wherein:

the conductive member includes a first insulation member disposed about an exterior surface of the conductive member; and

the defining includes removing at least a portion of a second insulation member from a portion of the pick-up electrode.

28. The method of claim 25, wherein:

the conductive member includes a first insulation member disposed about an exterior surface of the conductive member; and

the defining includes coupling a second insulation member to the proximal end portion of the conductive member.

29. The method of claim 25, wherein:

the pick-up electrode is a first pick-up electrode from a plurality of pick-up electrodes;

the stimulation electrode is a stimulation electrode from a plurality of stimulation electrodes, each stimulation electrode from the plurality of stimulation electrodes being electronically coupled to a corresponding pick-up electrode from the plurality of pick-up electrodes; and

the defining includes moving at least a portion of an insulation member such that at least portion of the insulation member is disposed about a second insulation member.

30. An apparatus, comprising:

a passive electrical conductor having a first end portion and a second end portion, the first end portion including a first electrical termination, the second end portion including a second electrical termination, the passive electrical conductor being insulated between the first end portion and the second end portion, the passive electrical conductor configured to be disposed within a body such that the first electrical termination is disposed adjacent a target tissue and the second electrical termination is beneath a surface of a skin; and

a backing member coupled to the second end portion of the passive electrical conductor, the backing member configured to direct a portion of a transcutaneous current produced by an electrode coupled to the surface of the skin to the second electrical termination.

31. The apparatus of claim 30, wherein the backing member is movably coupled to the second end portion of the passive electrical conductor.

32. The apparatus of claim 30, wherein the backing member is constructed from any one of silicone and polyester.

33. The apparatus of claim 30, wherein:

the first electrical termination is a stimulation electrode having a surface area less than approximately 50 square millimeters; and

the second electrical termination is a pick-up electrode having a coiled shape.

34. The apparatus of claim 30, further comprising:

an anchor coupled to the first end portion of the passive electrical conductor, the anchor configured to limit movement of the first electrical termination relative to the target tissue when the passive electrical conductor is disposed within the body.