Disc therapy

• US 9,950,156 B2
• Filed: 09/13/2016
• Issued: 04/24/2018
• Est. Priority Date: 09/13/2016
• Status: Active Grant

• Current Assignee: Discure Technologies Limited
• Original Assignee: Rainbow Medical Ltd.
• Inventors: Gross, Yossi, Sohn, Zev
• Primary Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US15/263,910
• Publication Number:
  US 20180071523A1
• Time in Patent Office: 588 Days
• Field of Search: 607 43, 607 46
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/205 for promoting a biological process
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment

Abstract

Apparatus is provided that includes at least one intra-pulposus exposed electrode surface, configured to be implanted in a nucleus pulposus of an intervertebral disc, and a plurality of extra-pulposus exposed electrode surfaces, configured to be implanted outside the nucleus pulposus, in electrical communication with the intervertebral disc. Control circuitry is configured to separately control at least two of the plurality of extra-pulposus exposed electrode surfaces, and to repeatedly alternatively assume: (a) a pressure-increasing mode of operation, in which fluid is electroosmotically driven into the nucleus pulposus to increase pressure in the intervertebral disc, by applying a first mean voltage of less than 1.23 V between the exposed electrode surfaces, and (b) an oxygen-generating mode of operation, in which oxygen is generated within the nucleus pulposus by electrolysis, by applying a second mean voltage of at least 1.23 V between the exposed electrode surfaces. Other embodiments are also described.

Claims

1. Apparatus for treating an intervertebral disc of a subject, the apparatus comprising:

at least one intra-pulposus exposed electrode surface, which is configured to be implanted in a nucleus pulposus of the intervertebral disc;

a plurality of extra-pulposus exposed electrode surfaces, which are configured to be implanted outside the nucleus pulposus, in electrical communication with the intervertebral disc; and

control circuitry, which is (a) electrically coupled to the at least one intra-pulposus exposed electrode surface and the plurality of extra-pulposus exposed electrode surfaces, (b) configured to separately control at least two of the plurality of extra-pulposus exposed electrode surfaces, and (c) configured to;

repeatedly assume a pressure-increasing mode of operation in alternation with an oxygen-generating mode of operation,

in the pressure-increasing mode of operation, (a) configure the at least one intra-pulposus exposed electrode surface to be a cathode, and one or more of the plurality of extra-pulposus exposed electrode surfaces to be one or more respective anodes, and (b) electroosmotically drive fluid into the nucleus pulposus to increase pressure in the intervertebral disc, by applying a first mean voltage of less than 1.23 V between the at least one intra-pulposus exposed electrode surface and the one or more of the plurality of extra-pulposus exposed electrode surfaces, and

in the oxygen-generating mode of operation, (a) configure the at least one intra-pulposus exposed electrode surface to be an anode, and the plurality of extra-pulposus exposed electrode surfaces to be a respective plurality of cathodes, and (b) generate oxygen within the nucleus pulposus by electrolysis, by applying a second mean voltage of at least 1.23 V between the at least one intra-pulposus exposed electrode surface and the plurality of extra-pulposus exposed electrode surfaces.

2. The apparatus according to claim 1, wherein the control circuitry is configured to separately control all of the plurality of extra-pulposus exposed electrode surfaces.

3. The apparatus according to claim 1, wherein the first mean voltage is less than 500 mV.

4. The apparatus according to claim 1, wherein the second mean voltage is at least 2 V.

5. The apparatus according to claim 1, wherein the control circuitry is configured, during a period of time, to assume (a) the pressure-increasing mode of operation at least 10 times for an aggregate first duration and (b) the oxygen-generating mode of operation at least 10 times for an aggregate second duration that is less than 10% of the aggregate first duration.

6. The apparatus according to claim 5, wherein the aggregate second duration is less than 1% of the aggregate first duration.

7. The apparatus according to claim 1, wherein the plurality of extra-pulposus exposed electrode surfaces comprises at least three extra-pulposus exposed electrode surfaces.

8. The apparatus according to claim 1, wherein the control circuitry is configured to, in the oxygen-generating mode of operation, generate oxygen within the nucleus pulposus by electrolysis, by applying the second mean voltage between the at least one intra-pulposus exposed electrode surface and respective different subsets of the plurality of extra-pulposus exposed electrode surfaces at respective different times.

9. The apparatus according to claim 8, wherein each of the subsets consists of exactly one of the plurality of extra-pulposus exposed electrode surfaces.

10. The apparatus according to claim 1,

wherein the apparatus further comprises a sensor, which is configured to sense a parameter indicative of a quantity of the oxygen generated by the electrolysis, and

wherein the control circuitry is configured to modulate the oxygen-generating mode of operation responsively to the sensed parameter.

11. The apparatus according to claim 10, wherein the sensed parameter is an oxygen concentration in the nucleus pulposus.

12. The apparatus according to claim 10, wherein the sensed parameter is a pH in the nucleus pulposus.

13. Apparatus for treating an intervertebral disc of a subject, the apparatus comprising:

at least one intra-pulposus exposed electrode surface, which is configured to be implanted in a nucleus pulposus of the intervertebral disc;

one or more extra-pulposus exposed electrode surfaces, which (a) are configured to be implanted outside the nucleus pulposus, in electrical communication with the intervertebral disc, and (b) have an aggregate electrically-exposed surface area of at least 1 cm2; and

control circuitry, which is (a) electrically coupled to the at least one intra-pulposus exposed electrode surface and one or more extra-pulposus exposed electrode surfaces, and (b) configured to;

repeatedly assume a pressure-increasing mode of operation in alternation with an oxygen-generating mode of operation,

in the pressure-increasing mode of operation, (a) configure the at least one intra-pulposus exposed electrode surface to be a cathode, and the one or more extra-pulposus exposed electrode surfaces to be one or more respective anodes, and (b) electroosmotically drive fluid into the nucleus pulposus to increase pressure in the intervertebral disc, by applying a first mean voltage of less than 1.23 V between the at least one intra-pulposus exposed electrode surface and the one or more extra-pulposus exposed electrode surfaces, and

in the oxygen-generating mode of operation, (a) configure the at least one intra-pulposus exposed electrode surface to be an anode, and the one or more extra-pulposus exposed electrode surfaces to be a respective plurality of cathodes, and (b) generate oxygen within the nucleus pulposus by electrolysis, by applying a second mean voltage of at least 1.23 V between the at least one intra-pulposus exposed electrode surface and the one or more extra-pulposus exposed electrode surfaces.

14. The apparatus according to claim 13, wherein the aggregate electrically-exposed surface area is at least 3 cm2.

15. The apparatus according to claim 13, wherein the first mean voltage is less than 500 mV.

16. The apparatus according to claim 13, wherein the second mean voltage is at least 2 V.

17. The apparatus according to claim 13, wherein the control circuitry is configured, during a period of time, to assume (a) the pressure-increasing mode of operation at least 10 times for an aggregate first duration and (b) the oxygen-generating mode of operation at least 10 times for an aggregate second duration that is less than 10% of the aggregate first duration.

18. The apparatus according to claim 17, wherein the aggregate second duration is less than 1% of the aggregate first duration.

19. The apparatus according to claim 13, wherein the apparatus comprises exactly one extra-pulposus exposed electrode surface having an electrically-exposed surface area of at least 1 cm2.

20. The apparatus according to claim 19, wherein the surface area of the of the exactly one extra-pulposus exposed electrode surface is at least 3 cm2.

21. The apparatus according to claim 13, wherein the apparatus comprises a plurality of extra-pulposus exposed electrode surfaces.

22. The apparatus according to claim 13,

wherein the apparatus further comprises a sensor, which is configured to sense a parameter indicative of a quantity of the oxygen generated by the electrolysis, and

wherein the control circuitry is configured to modulate the oxygen-generating mode of operation responsively to the sensed parameter.

23. The apparatus according to claim 22, wherein the sensed parameter is an oxygen concentration in the nucleus pulposus.

24. The apparatus according to claim 22, wherein the sensed parameter is a pH in the nucleus pulposus.

25. A method for treating an intervertebral disc of a subject, the method comprising:

implanting at least one intra-pulposus exposed electrode surface in a nucleus pulposus of the intervertebral disc;

implanting a plurality of extra-pulposus exposed electrode surfaces outside the nucleus pulposus, in electrical communication with the intervertebral disc; and

activating control circuitry, which is (a) electrically coupled to the at least one intra-pulposus exposed electrode surface and the plurality of extra-pulposus exposed electrode surfaces, and (b) configured to separately control at least two of the plurality of extra-pulposus exposed electrode surfaces, to;

repeatedly assume a pressure-increasing mode of operation in alternation with an oxygen-generating mode of operation,

in the pressure-increasing mode of operation, (a) configure the at least one intra-pulposus exposed electrode surface to be a cathode, and one or more of the plurality of extra-pulposus exposed electrode surfaces to be one or more respective anodes, and (b) electroosmotically drive fluid into the nucleus pulposus to increase pressure in the intervertebral disc, by applying a first mean voltage of less than 1.23 V between the at least one intra-pulposus exposed electrode surface and the one or more of the plurality of extra-pulposus exposed electrode surfaces, and

in the oxygen-generating mode of operation, (a) configure the at least one intra-pulposus exposed electrode surface to be an anode, and the plurality of extra-pulposus exposed electrode surfaces to be a respective plurality of cathodes, and (b) generate oxygen within the nucleus pulposus by electrolysis, by applying a second mean voltage of at least 1.23 V between the at least one intra-pulposus exposed electrode surface and the plurality of extra-pulposus exposed electrode surfaces.

26. A method for treating an intervertebral disc of a subject, the method comprising:

implanting at least one intra-pulposus exposed electrode surface in a nucleus pulposus of the intervertebral disc;

implanting one or more extra-pulposus exposed electrode surfaces outside the nucleus pulposus, in electrical communication with the intervertebral disc, the one or more extra-pulposus exposed electrode surfaces having an aggregate electrically-exposed surface area of at least 1 cm2; and

activating control circuitry, which is electrically coupled to the at least one intra-pulposus exposed electrode surface and one or more extra-pulposus exposed electrode surfaces, to;

repeatedly assume a pressure-increasing mode of operation in alternation with an oxygen-generating mode of operation,

in the pressure-increasing mode of operation, (a) configure the at least one intra-pulposus exposed electrode surface to be a cathode, and the one or more extra-pulposus exposed electrode surfaces to be one or more respective anodes, and (b) electroosmotically drive fluid into the nucleus pulposus to increase pressure in the intervertebral disc, by applying a first mean voltage of less than 1.23 V between the at least one intra-pulposus exposed electrode surface and the one or more extra-pulposus exposed electrode surfaces, and

in the oxygen-generating mode of operation, (a) configure the at least one intra-pulposus exposed electrode surface to be an anode, and the one or more extra-pulposus exposed electrode surfaces to be a respective plurality of cathodes, and (b) generate oxygen within the nucleus pulposus by electrolysis, by applying a second mean voltage of at least 1.23 V between the at least one intra-pulposus exposed electrode surface and the one or more extra-pulposus exposed electrode surfaces.

27. Apparatus comprising an electrode, which comprises a wire that (a) has a wire diameter of between 75 and 125 microns and (b) includes:

a non-electrically-insulated current-application longitudinal segment, which, in the absence of any applied forces, is coiled and has (i) a mean pitch of between 1.1 and 2 times the wire diameter, and (ii) an entire longitudinal length of between 5 and 35 mm, and

an electrically-insulated lead longitudinal segment, which has an entire longitudinal length of between 5 and 80 mm, in the absence of any applied forces.