TREATMENT OF INDICATIONS USING ELECTRICAL STIMULATION

• US 20110282412A1
• Filed: 06/24/2009
• Published: 11/17/2011
• Est. Priority Date: 06/27/2008
• Status: Active Grant

• Current Assignee: Bioness Inc. (Smith & Nephew PLC)
• Original Assignee: Bioness Inc. (Smith & Nephew PLC)
• Inventors: Lindon, Mark L., Glukhovsky, Arkady, Zilberman, Yitzhak
• Granted Patent: US 9,925,374 B2
• Time in Patent Office: Days
• US Class Current: 607/41
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

In one embodiment, a method includes implanting an implant entirely under the subject'"'"'s skin. The implant includes a passive electrical conductor of sufficient length to extend from subcutaneous tissue located below one of a surface cathodic electrode and a surface anodic electrode to the tibial nerve. The surface electrodes are positioned in spaced relationship on the subject'"'"'s skin, with one of the electrodes positioned over the pick-up end of the electrical conductor such that the portion of the current is transmitted through the conductor to the tibial nerve, and such that the current flows through the tibial nerve and returns to the other of the surface cathodic electrode and the surface anodic electrode. An electrical current is applied between the surface cathodic electrode and the surface anodic electrode to cause the portion of the electrical current to flow through the implant to stimulate the tibial nerve.

Claims

1. An apparatus for electrically stimulating a tibial nerve to treat incontinence in a subject, comprising:

an implant configured to be disposed in the subject'"'"'s body, the implant including a passive electrical conductor configured to be in electrical communication with a first surface electrode and a second surface electrode when the passive electrical conductor is implanted, the passive electrical conductor including

a pick-up portion configured to pick-up at least a portion of an electrical current flowing between the first surface electrode and the second surface electrode;

a delivery portion configured to deliver the portion of electrical current to the tibial nerve to stimulate the tibial nerve; and

an insulated body portion disposed between the pick-up portion and the delivery portion.

2. The apparatus of claim 1, wherein the pick-up portion of the implant is configured to be positioned in subcutaneous tissue below one of the first surface electrode or the second surface electrode.

3. The apparatus of claim 1, wherein the delivery portion of the implant is configured to be positioned in subcutaneous tissue below one of the first surface electrode or the second surface electrode.

4. The apparatus of claim 1, wherein the pick-up portion includes an electrode.

5. The apparatus of claim 1, wherein the delivery portion includes an electrode.

6. The apparatus of claim 1, wherein:

the pick-up portion forms an electrical termination having a sufficient surface area such that, once implanted in subcutaneous tissue below one of the first surface electrode and the second surface electrode, the portion of the electric current flows through the electrical conductor, in preference to flowing through body 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 electric current to the tibial nerve, once implanted.

7. A method for electrically stimulating a tibial nerve to treat incontinence in a subject, comprising:

implanting an implant in the subject'"'"'s body, the implant including a passive electrical conductor having a pick-up portion and a delivery portion, the pick-up portion being configured to pick up at least a portion of an electrical current flowing between a first surface electrode and a second surface electrode and to transmit the portion of the electrical current to the tibial nerve;

positioning the first surface electrode and the second surface electrode in spaced relationship on the body, with one of the first surface electrode and the second surface electrode positioned over the pick-up portion of the electrical conductor so the portion of the electrical current is transmitted through the electrical conductor to the tibial nerve; and

applying an electrical 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 tibial nerve.

8. The method of claim 7, wherein during the applying, after the electric current is transmitted to the tibial nerve, at least a portion of the electric current is transmitted through body tissues extending between the tibial nerve and subcutaneous tissue located below the other of the first surface electrode and the second surface electrode.

9. The method of claim 7, wherein during the applying, after the electric current is transmitted to the tibial nerve, at least a portion of the electric current is transmitted through an implanted electrical return conductor extending between the tibial nerve and subcutaneous tissue located below the other of the first surface electrode and the second surface electrode.

10. The method of claim 7, wherein the applying includes, applying at least one of direct, pulsatile or alternating electrical current between the first surface electrode and the second surface electrode.

11. The method of claim 7, wherein the implanting includes implanting in the subject'"'"'s body the passive electrical conductor, the passive electrical conductor being insulated between the pick-up portion and the delivery portion.

12. The method of claim 7, wherein:

the first surface electrode and the second surface electrode are configured to make electrical contact with a subject'"'"'s skin; and

the conductor has a length sufficient to extend, once implanted, from subcutaneous tissue located below the first surface electrode to the tibial nerve.

13. The method of claim 7, wherein:

the pick-up portion forms an electrical termination having a sufficient surface area such that, once implanted in subcutaneous tissue below one of the first surface electrode and the second surface electrode, the portion of the electric current flows through the conductor, in preference to flowing through body 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 electric current to the tibial nerve, once implanted.

14. A method for electrically stimulating a wound in a subject, comprising:

implanting an implant in the subject'"'"'s body, the implant including a passive electrical conductor having a pick-up portion and a delivery portion, the pick-up portion being configured to pick up at least a portion of an electrical current flowing between a first surface electrode and a second surface electrode and to transmit the portion of the electrical current to the wound;

positioning the first surface electrode and the second surface electrode in spaced relationship on the body, with one of the first surface electrode and the second 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 wound; and

applying an electrical 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 wound and stimulate wound healing.

15. The method of claim 14, wherein during the applying, after the electric current is transmitted to the wound, at least a portion of the electric current is transmitted through body tissues extending between the wound and subcutaneous tissue located below the other of the first surface electrode and the second surface electrode.

16. The method of claim 14, wherein during the applying, after the electric current is transmitted to the wound, at least a portion of the electric current is transmitted through an implanted electrical return conductor extending between the wound and subcutaneous tissue located below the other of the first surface electrode and the second surface electrode.

17. The method of claim 14, wherein the applying includes, applying at least one of direct, pulsatile or alternating electrical current between the first surface electrode and the second surface electrode.

18. The method of claim 14, wherein the wound is on a surface of the subject'"'"'s skin.

19. The method of claim 14, wherein the wound is disposed below a subcutaneous tissue of the subject.

20. The method of claim 14, wherein:

the first surface electrode and the second surface electrode are configured to make electrical contact with a subject'"'"'s skin; and

the conductor has a length sufficient to extend, once implanted, from subcutaneous tissue located below the first surface electrode to the wound.

21. The method of claim 14, wherein:

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

22. A method for electrically stimulating a tissue in proximity to a joint in a subject, comprising:

implanting an implant in the subject'"'"'s body, the implant including a passive electrical conductor having a pick-up portion and a delivery portion, the pick-up portion being configured to pick up at least a portion of an electrical current flowing between a first surface electrode and a second surface electrode and to transmit the portion of the electrical current to a tissue in proximity to a joint;

positioning the first surface electrode and the second surface electrode in spaced relationship on the body, with one of the first surface electrode and the second surface electrode positioned over the pick-up portion of the electrical conductor so the portion of the current is transmitted through the conductor to the tissue in proximity to the joint; and

applying an electrical 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 joint.

23. The method of claim 22, wherein during the applying, after the electric current is transmitted to the tissue in proximity to the joint, at least a portion of the electric current is transmitted through body tissues extending between the joint and subcutaneous tissue located below the other of the first surface electrode and the second surface electrode.

24. The method of claim 22, wherein during the applying, after the electric current is transmitted to the tissue in proximity to the joint, at least a portion of the electric current is transmitted through an implanted electrical return conductor extending between the joint and subcutaneous tissue located below the other of the first surface electrode and the second surface electrode.

25. The method of claim 22, wherein the applying includes, applying at least one of direct, pulsatile or alternating electrical current between the first surface electrode and the second surface electrode.

26. The method of claim 22, wherein the joint is one of a knee joint and a hip joint.

27. The method of claim 22, wherein the applying electrical current to the joint includes stimulation of the joint sufficient to treat at least one of joint pain or arthritis.

28. The method of claim 22, wherein:

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

29. A method for electrically stimulating a common peroneal nerve in a subject, comprising:

disposing a first end of an implant under a subject'"'"'s skin at a first location in proximity to a common peroneal nerve of the patient;

disposing a second end of the implant under the subject'"'"'s skin at a second location at a non-zero distance from the first end of the implant, the implant including a passive electrical conductor extending under the subject'"'"'s skin between the first end and the second end;

placing a first surface electrode on an exterior surface of the subject'"'"'s skin at a first location;

placing a second surface electrode on an exterior surface of the subject'"'"'s skin in spaced relationship to the first surface electrode; and

delivering an electrical current to one of the first surface electrode and the second surface electrode such that a portion of the electric current is transmitted through the second end of the implant, through the conductor to the first end of the implant and into the common peroneal nerve to stimulate the common peroneal nerve.

30. The method of claim 29, wherein during the applying, after the electric current is transmitted to the common peroneal nerve, at least a portion of the electric current is transmitted through body tissues extending between the joint and subcutaneous tissue located below the other of the first surface electrode and the second surface electrode.

31. The method of claim 29, wherein during the applying, after the electric current is transmitted to the joint, at least a portion of the electric current is transmitted through an implanted electrical return conductor extending between the common peroneal nerve and subcutaneous tissue located below the other of the first surface electrode and the second surface electrode.

32. The method of claim 29, wherein the applying includes, applying at least one of direct, pulsatile or alternating electrical current between the first surface electrode and the second surface electrode.

33. A method for electrically stimulating a muscle in a subject, comprising:

disposing a first end of an implant under a subject'"'"'s skin at a first location in proximity to at least one of a muscle or a nerve innervating the muscle of the subject;

disposing a second end of the implant under the subject'"'"'s skin at a second location at a non-zero distance from the first end of the implant, the implant including a passive electrical conductor extending under the subject'"'"'s skin between the first end and the second end;

placing a first surface electrode on an exterior surface of the subject'"'"'s skin at a first location;

placing a second surface electrode on an exterior surface of the subject'"'"'s skin in spaced relationship to the first surface electrode; and

delivering an electrical current to one of the first surface electrode and the second surface electrode such that a portion of the electric current is transmitted through the second end of the implant, through the conductor to the first end of the implant and into the one of the muscle or the nerve innervating the muscle to stimulate rehabilitation of the muscle.

34. The method of claim 33, further comprising:

attaching a vibration sensor capable of detecting mechanical vibrations to subject; and

detecting with the sensor, mechanical vibrations elicited by sudden contact of the subject'"'"'s upper teeth and lower teeth,

the delivering being actuated based on the detecting.

35. A method for electrically stimulating a fracture or break in a bone of a subject to promote bone growth, comprising:

disposing a first end of an implant under a subject'"'"'s skin at a first location in proximity to a targeted bone defect of the subject;

disposing a second end of the implant under the subject'"'"'s skin at a second location at a non-zero distance from the first end of the implant, the implant including a passive electrical conductor extending under the subject'"'"'s skin between the first end and the second end;

placing a first surface electrode on an exterior surface of the subject'"'"'s skin at a first location;

placing a second surface electrode on an exterior surface of the subject'"'"'s skin in spaced relationship to the first surface electrode; and

delivering an electrical current to one of the first surface electrode and the second surface electrode such that a portion of the electric current is transmitted through the second end of the implant, through the conductor to the first end of the implant and into the targeted bone defect to promote bone growth.

36. The method of claim 35, further comprising:

positioning an orthosis on an exterior portion of the subject and adjacent the second end of the implant, wherein the delivering includes delivering electrical current from the orthosis to one of the first surface electrode and the second surface electrode.

37. A method for electrically stimulating a nerve associated with sensations in a region of a subject'"'"'s head or face to treat at least one of headache pain or facial pain in a subject, comprising:

implanting an implant in the subject'"'"'s body, the implant including a passive electrical conductor having a pick-up portion and a delivery portion, the pick-up portion being configured to pick up at least a portion of an electrical current flowing between a first surface electrode and a second surface electrode and to transmit the portion of the electrical current to the nerve;

positioning the first surface electrode and the second surface electrode in spaced relationship on the body, with the first surface electrode positioned over the pick-up portion of the electrical conductor so the portion of the electrical current is transmitted through the electrical conductor to the nerve; and

applying an electrical 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 nerve and alleviate headache pain or facial pain in the subject.

38. The method of claim 37, wherein the nerve includes at least one of a trigeminal nerve, a branch of the trigeminal nerve, a trigeminal ganglion, an ophthalmic nerve, a branch of the ophthalmic nerve, a maxillary nerve, a branch of the maxillary nerve, a mandibular nerve, a branch of the mandibular nerve, a greater occipital nerve, a branch of the greater occipital nerve, a lesser occipital nerve, a branch of the lesser occipital nerve, a third occipital nerve, a branch of the third occipital nerve, a great auricular nerve, a branch of the great auricular nerve, a transverse cervical nerve, a branch of the transverse cervical nerve, a supraclavicular nerve, or a branch of the supraclavicular nerve.

39. The method of claim 37, wherein during the applying, after the electric current is transmitted to the nerve, at least a portion of the electric current is transmitted through body tissues extending between the nerve and subcutaneous tissue located below the other of the first surface electrode and the second surface electrode.

40. The method of claim 37, wherein during the applying, after the electric current is transmitted to the nerve, at least a portion of the electric current is transmitted through an implanted electrical return conductor extending between the nerve and subcutaneous tissue located below the other of the first surface electrode and the second surface electrode.

41. The method of claim 37, wherein the applying includes, applying at least one of direct current, pulsatile current or alternating electrical current between the first surface electrode and the second surface electrode.

42. The method of claim 37, wherein the applying includes applying electrical current to the nerve at a frequency of less than about 100 Hz.

43. The method of claim 37, wherein the applying includes applying electrical current to the nerve at a frequency of greater than about 150 Hz.

44. The method of claim 37, wherein the implanting includes implanting in the subject'"'"'s body the passive electrical conductor, the passive electrical conductor being insulated between the pick-up portion and the delivery portion.

45. The method of claim 37, wherein:

the first surface electrode and the second surface electrode are configured to make electrical contact with a subject'"'"'s skin; and

the conductor has a length sufficient to extend, once implanted, from subcutaneous tissue located below the first surface electrode to the nerve.

46. The method of claim 37, 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 electric current flows through the conductor, in preference to flowing through body 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 electric current to the nerve, once implanted.

47. An apparatus for electrically stimulating a nerve associated with sensations in a region of a subject'"'"'s head or face to treat at least one of headache pain or facial pain in a subject, comprising:

an implant configured to be disposed in the subject'"'"'s body, the implant including a passive electrical conductor configured to be in electrical communication with a first surface electrode and a second surface electrode when the passive electrical conductor is implanted, the passive electrical conductor including

a pick-up portion configured to pick up at least a portion of an electrical current flowing between the first surface electrode and the second surface electrode;

a delivery portion configured to deliver the portion of electrical current to the nerve to stimulate the nerve and alleviate headache pain or facial pain in the subject; and

an insulated body portion disposed between the pick-up portion and the delivery portion.

48. The apparatus of claim 47, wherein the nerve includes at least one of a trigeminal nerve, a branch of the trigeminal nerve, a trigeminal ganglion, an ophthalmic nerve, a branch of the ophthalmic nerve, a maxillary nerve, a branch of the maxillary nerve, a mandibular nerve, a branch of the mandibular nerve, a greater occipital nerve, a branch of the greater occipital nerve, a lesser occipital nerve, a branch of the lesser occipital nerve, a third occipital nerve, a branch of the third occipital nerve, a great auricular nerve, a branch of the great auricular nerve, a transverse cervical nerve, a branch of the transverse cervical nerve, a supraclavicular nerve, and a branch of the supraclavicular nerve.

49. The apparatus of claim 47, wherein the pick-up portion is configured to be positioned in subcutaneous tissue below one of the first surface electrode or the second surface electrode.

50. The apparatus of claim 47, wherein the pick-up portion is configured to be positioned in subcutaneous tissue below one of the first surface electrode or the second surface electrode.

51. The apparatus of claim 47, wherein the pick-up portion includes an electrode.

52. The apparatus of claim 47, wherein the delivery portion includes an electrode.

53. The apparatus of claim 47, wherein:

the first surface electrode and the second surface electrode are configured to make electrical contact with a subject'"'"'s skin; and

the electrical conductor has a length sufficient to extend, once implanted, from subcutaneous tissue located below the first surface electrode to the nerve which is to be stimulated.

54. The apparatus of claim 47, 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 electric current flows through the electrical conductor, in preference to flowing through body 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 electric current to the nerve, once implanted.