TIBIAL NERVE STIMULATION

• US 20110301670A1
• Filed: 06/08/2010
• Published: 12/08/2011
• Est. Priority Date: 06/08/2010
• Status: Active Grant

• Current Assignee: BlueWind Medical Ltd.
• Original Assignee: Rainbow Medical Ltd.
• Inventors: Gross, Yossi, Kinrot, Noam
• Granted Patent: US 8,788,045 B2
• Time in Patent Office: Days
• US Class Current: 607/62
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/3616 Voltage density or current density
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

Apparatus and methods are described, including identifying a subject as suffering from polyneuropathy. In response to the identifying, electrodes are placed within 1 mm of a tibial nerve of the subject, the electrodes being disposed on a housing that is at least partially flexible. The electrodes are driven to treat the polyneuropathy by driving a current into the tibial nerve. Other embodiments are also described.

Claims

1. A method, comprising:

identifying a subject as suffering from polyneuropathy; and

in response to the identifying;

placing electrodes within 1 mm of a tibial nerve of the subject, the electrodes being disposed on a housing that is at least partially flexible; and

driving the electrodes to treat the polyneuropathy by driving a current into the tibial nerve.

2. The method according to claim 1, wherein placing the electrodes comprises:

when the electrodes are driven to drive the current into the tibial nerve,

reducing a current path from the electrodes away from the tibial nerve, using the housing, by

placing the electrodes within 1 mm of the tibial nerve, in a given configuration with respect to the housing.

3. The method according to claim 1, further comprising detecting a myographic signal of the subject, wherein driving the electrodes comprises driving the electrodes responsively to the myographic signal.

4. The method according to claim 1, wherein the housing includes flexible and rigid portions thereof, the portions being articulatably coupled to each other, and wherein placing the electrodes within 1 mm of the tibial nerve comprises placing the electrodes within 1 mm of the tibial nerve of the subject, the electrodes being disposed on the housing that includes the flexible and the rigid portions thereof.

5. The method according to claim 1, further comprising, subsequent to placing the electrodes within 1 mm of the tibial nerve of the subject, coupling the housing to the tibial nerve by changing a shape of the housing.

6. The method according to claim 1, wherein placing the electrodes within 1 mm of the tibial nerve of the subject comprises placing the electrodes in contact with the tibial nerve.

10. The method according to claim 1, wherein placing the electrodes comprises placing the electrodes within 0.3 mm of the tibial nerve.

14. The method according to claim 1, wherein driving the electrodes to drive the current comprises driving the electrodes to drive a current having a frequency of 40 Hz to 60 Hz.

15. The method according to claim 1, wherein driving the electrodes to drive the current comprises driving the electrodes to drive the current for a therapy period having a duration of between two minutes and ten minutes.

16. The method according to claim 15, wherein driving the electrodes to drive the current for the therapy period comprises driving the electrodes to drive the current during 2-8 therapy periods per day.

17. The method according to claim 15, wherein driving the electrodes to drive the current for the therapy period comprises driving the electrodes to drive the current during 2-8 therapy periods per week.

19. The method according to claim 1, wherein driving the electrodes to drive the current comprises driving the electrodes to drive a current having an amplitude of between 0.5 mA and 4 mA.

20. The method according to claim 1, wherein placing electrodes within 1 mm of the tibial nerve of the subject comprises inserting the electrodes into the tibial nerve.

7-9. -9. (canceled)

11-13. -13. (canceled)

18. (canceled)

21-24. -24. (canceled)

25. Apparatus for treating polyneuropathy of a subject, comprising:

one or more electrodes configured to be placed in contact with a portion of the subject'"'"'s body within 1 mm of a tibial nerve of the subject;

a housing that is at least partially flexible configured to support the electrodes and to maintain contact between the electrodes and the portion by bending; and

a control unit configured to be placed outside a body of the subject, and to drive the electrodes to treat the polyneuropathy by driving a current into the tibial nerve.

26. The apparatus according to claim 25, wherein the housing comprises a shape-change material, and wherein the housing is configured to maintain contact between the electrodes and the portion by changing a shape of the housing.

27. The apparatus according to claim 25, wherein the housing is configured to reduce a current path from the electrodes away from the tibial nerve.

30. The apparatus according to claim 25, wherein the electrodes are configured to be placed in contact with the tibial nerve.

32. The apparatus according to claim 25, wherein the housing comprises flexible and rigid portions thereof, the portions being articulatably coupled to each other.

33. The apparatus according to claim 32, further comprising an implantable control component configured to receive a signal from the control unit, wherein the implantable control component is disposed within the rigid portion of the housing, and the electrodes are disposed within the flexible portion of the housing.

41. The apparatus according to claim 25, wherein the electrodes are configured to be inserted into the tibial nerve.

42. The apparatus according to claim 41, further comprising one or more springs coupled to the one or more electrodes and configured to insert the electrodes into the tibial nerve by expanding.

43. The apparatus according to claim 25, further comprising an introducer, wherein the electrodes are configured to be placed in contact with the subject'"'"'s tibial nerve by the housing being injected to a vicinity of the tibial nerve via the introducer.

44. The apparatus according to claim 43, further comprising coupling elements that are coupled to the housing and that are configured to automatically couple the housing to the tibial nerve by automatically becoming anchored to tissue in the vicinity of the tibial nerve.

45. The apparatus according to claim 43, wherein the coupling elements comprise spiral coupling elements.

46. The apparatus according to claim 43, wherein the introducer and the housing are shaped such that a rotational position of the electrodes is fixed with respect to the introducer during injection of the housing via the introducer.

47. The apparatus according to claim 46, wherein the housing has a non-circular cross-section and the introducer is shaped to define a lumen that has a non-circular cross-section that corresponds to the cross-section of the housing.

51. The apparatus according to claim 25, wherein the one or more electrodes are configured to be placed in contact with a portion of the subject'"'"'s body within 0.3 mm of the tibial nerve.

28-29. -29. (canceled)

31. (canceled)

34-40. -40. (canceled)

48-50. -50. (canceled)