Tibial nerve stimulation

• US 8,788,045 B2
• Filed: 06/08/2010
• Issued: 07/22/2014
• Est. Priority Date: 06/08/2010
• Status: Active Grant

• Current Assignee: BlueWind Medical Ltd.
• Original Assignee: BlueWind Medical Ltd.
• Inventors: Gross, Yossi, Kinrot, Noam
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US12/796,102
• Publication Number:
  US 20110301670A1
• Time in Patent Office: 1,505 Days
• Field of Search: 607/46, 607/49
• US Class Current: 607/46
• 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 in contact with a portion of the subject'"'"'s body within 1 mm of a tibial nerve of the subject, the electrodes being disposed on a housing that includes flexible and rigid portions thereof, the portions being articulatably coupled to each other via a joint of the housing that is more flexible than the flexible portion such as to maintain contact between the electrodes and the portion of the subject'"'"'s body by the housing articulating; 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, 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.

5. 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.

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

7. 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 20 Hz to 60 Hz.

8. 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.

9. The method according to claim 8, 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.

10. The method according to claim 8, 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.

11. 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 8 mA.

12. 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.

13. The method according to claim 1, wherein placing the electrodes disposed on the housing that includes flexible and rigid portions thereof comprises placing the electrodes disposed on a housing that includes flexible and rigid portions thereof, the rigid portion including a control component that is configured to receive a signal from a control unit that is disposed outside the subject'"'"'s body.

14. The method according to claim 1, wherein the flexible and rigid portions of the housing have respective crescent-shaped cross sections, and wherein placing the electrodes comprises placing the electrodes, such that each of the flexible and rigid portions is disposed at least partway around the tibial nerve.

15. The method according to claim 1, wherein:

the flexible portion of the housing includes a first flexible portion, articulatably coupled at a first end thereof to the rigid portion via the joint, and the apparatus further includes a second flexible portion, articulatably coupled to a second end of the first flexible portion via another joint that is more flexible than the first flexible portion and the second flexible portion, and

placing the electrodes comprises placing the electrodes disposed on the housing that includes the first flexible portion that is articulatably coupled to the rigid portion and to the second flexible portion via the joints.

16. The method according to claim 1, wherein placing the electrodes comprises injecting the flexible and rigid portions into the subject via an introducer.

17. The method according to claim 16, wherein placing the electrodes comprises coupling the housing to the nerve while at least part of the housing is disposed within the introducer, and subsequently pushing at least the part of the housing out of the introducer.

18. 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, the housing comprising flexible and rigid portions thereof, the portions being articulatably coupled to each other via a joint of the housing that is more flexible than the flexible portion, the housing being configured to support the electrodes and to maintain contact between the electrodes and the portion of the subject'"'"'s body by articulating; 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.

19. The apparatus according to claim 18, wherein the housing comprises a shape-change material, and wherein the housing is configured to maintain contact between the electrodes and the portion of the subject'"'"'s body by changing a shape of the housing.

20. The apparatus according to claim 18, wherein the housing is configured to reduce a current path from the electrodes away from the tibial nerve.

21. The apparatus according to claim 18, wherein the electrodes are configured to be placed in contact with the tibial nerve.

22. The apparatus according to claim 18, 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.

23. The apparatus according to claim 18, wherein the electrodes are configured to be inserted into the tibial nerve.

24. The apparatus according to claim 23, 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.

25. The apparatus according to claim 18, 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.

26. The apparatus according to claim 18, 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.

27. The apparatus according to claim 18, wherein the flexible and rigid portions of the housing have respective crescent-shaped cross sections configured to facilitate placement of the flexible and rigid portions at least partway around the tibial nerve.

28. The apparatus according to claim 18, wherein the flexible portion of the housing comprises a first flexible portion, articulatably coupled at a first end thereof to the rigid portion via the joint, and the apparatus further comprises a second flexible portion, articulatably coupled to a second end of the first flexible portion via another joint that is more flexible than the first flexible portion and the second flexible portion.

29. The apparatus according to claim 18, further comprising an introducer, wherein the introducer and the housing are configured such that the flexible and rigid portions are injectable into the subject via the introducer.

30. The apparatus according to claim 29, further comprising a pushing element, wherein (1) the housing is configured to be coupled to the nerve of the subject while at least part of the housing is disposed within the introducer, and (2) the introducer and the housing are configured to facilitate pushing, by the pushing element, of at least the part of the housing out of the introducer subsequently to the coupling of the housing to the nerve.