Neuromodulation stimulation for the restoration of sexual function

• US 20060149345A1
• Filed: 11/30/2005
• Published: 07/06/2006
• Est. Priority Date: 09/12/2003
• Status: Abandoned Application

• Current Assignee: Medtronic Urinary Solutions, Inc. (Medtronic Plc)
• Original Assignee: NDI Medical, LLC
• Inventors: Bennett, Maria E., Thrope, Geoffrey B., Boggs, Joseph W. II, Zmina, Therese M.
• Application Number:
  US11/290,268
• Publication Number:
  US 20060149345A1
• Time in Patent Office: Days
• US Class Current: 607/118
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Systems and methods use an implantable pulse generator system for neuromodulation stimulation to treat sexual dysfunction by the unilateral or bilateral stimulation of the left and/or right branches of the dorsal genital nerves using one or more leads and electrodes implanted in adipose or other tissue in the region at or near the pubic symphysis. A neuromodulation stimulation waveform includes at least a variable frequency component and/or a variable duty cycle component and/or a variable amplitude component and/or a variable pause component to ward off habituation.

Claims

1. A system for stimulating a left and/or right branch of the dorsal genital nerves for the treatment of sexual dysfunction comprising

a stimulation electrode sized and configured to be implanted in a tissue region at or near a pubic symphysis,

an implantable pulse generator to convey electrical stimulation waveforms to the stimulation electrode to stimulate the left branch and/or the right branch of the dorsal genital nerves.

2. A system according to claim 1

the stimulation electrode further comprising

at least one elongated lead sized and configured to be implanted in the tissue region, the lead including a cuff electrode for placement on the left branch and/or the right branch of the dorsal genital nerves, the cuff electrode comprising

an elastic body having an elastic memory,

at least one electrically conductive surface coupled to an inside surface of the elastic body, and

the body and electrically conductive surface assuming a coiled configuration in its natural shape, the coiled configuration allowing an intimate contact between the electrically conductive surface on the inside surface of the elastic body and the left branch or the right branch of the dorsal genital nerves surrounded.

3. A system according to claim 1

wherein the stimulation waveforms conveyed to the stimulation electrode affect afferent stimulation of the left and/or right branches of the dorsal genital nerves, the afferent stimulation activating spinal circuitry that coordinates efferent activity in the cavernous nerve and efferent activity in the pudendal nerve, producing a sexual function.

4. A system according to claim 1

wherein the electrical stimulation waveform includes at least a variable frequency component and/or a variable duty cycle component and/or a variable amplitude component and/or a variable pause component to ward off habituation.

5. A system according to claim 1

wherein the electrical stimulation waveform includes a variable frequency in the range of about one Hz to about fifteen Hz, and a variable amplitude in the range of about 100 microamps to about 20 milliamps, and a variable duty cycle in the range of about zero seconds to about ten seconds, and a variable pause component in the range of about zero seconds to about ten seconds.

6. A system according to claim 1

wherein the stimulation electrode is sized and configured to be implanted in adipose tissue.

7. A system according to claim 6

the stimulation electrode further comprising

an elongated lead sized and configured to be implanted within the adipose tissue region, the lead including at least two electrically conductive portions to apply electrical stimulation to nerve tissue in the adipose tissue region, and at least two expandable anchoring structures deployable from the lead to engage adipose tissue and resist dislodgment and/or migration of the at least two electrically conductive portions within the adipose tissue region.

8. A system according to claim 7,

wherein the at least two electrically conductive portions can be configured to function as two individual stimulating electrodes in a monopolar configuration or as one stimulating electrode in a bipolar configuration.

9. A system according to claim 7,

wherein each expandable anchoring structure includes two circumferentially radiating shovel-like blade shaped members spaced 180 degrees apart.

10. A system according to claim 1

wherein only one stimulation electrode is implanted.

11. A system according to claim 10

wherein the stimulation waveforms conveyed to the one stimulation electrode affect bilateral stimulation of the left and right branches of the dorsal genital nerves.

12. A system according to claim 10

wherein the stimulation waveforms conveyed to the one stimulation electrode affect stimulation of at least one of the left and right branches of the dorsal genital nerves.

13. A system according to claim 1

wherein at least a first stimulation electrode and a second stimulation electrode are implanted.

14. A system according to claim 13

wherein the stimulation waveforms conveyed to the at least a first stimulation electrode affect stimulation of the left and/or right branches of the dorsal genital nerves, and the stimulation waveforms conveyed to the at least a second stimulation electrode affect stimulation of the left and/or right branches of the dorsal genital nerves.

15. A system according to claim 13

wherein the second stimulation electrode is sized and configured to be implanted in, on, or near the cavernous nerve and/or the pudendal nerve.

16. A system according to claim 15

further including a third stimulation electrode, the second stimulation electrode being sized and configured to be implanted in, on, or near the cavernous nerve and the third stimulation electrode being sized and configured to be implanted in, on, or near the pudendal nerve.

26. A method of using the system defined in claim 1.

17. A method for treating sexual dysfunction comprising

implanting at least one stimulation electrode in tissue at or near a pubic symphysis, and

applying stimulation waveforms to the at least one stimulation electrode to achieve stimulation of left and/or right branches of the dorsal genital nerves.

18. A system according to claim 17

wherein the stimulation waveforms conveyed to the at least one stimulation electrode affect afferent stimulation of the left and/or right branches of the dorsal genital nerves, the afferent stimulation activating spinal circuitry that coordinates efferent activity in the cavernous nerve and efferent activity in the pudendal nerve, producing a sexual function.

19. A method according to claim 17

wherein the electrical stimulation waveform includes at least a variable frequency component and/or a variable duty cycle component and/or a variable amplitude component and/or a variable pause component to ward off habituation.

20. A method according to claim 17

wherein the electrical stimulation waveform includes a variable frequency in the range of about one Hz to about fifteen Hz, and a variable amplitude in the range of about 100 microamps to about 20 milliamps, and a variable duty cycle in the range of about zero seconds to about ten seconds and a variable pause component in the range of about zero seconds to about ten seconds.

21. A method according to claim 17

wherein the at least one stimulation electrode is sized and configured to be implanted in adipose tissue.

22. A method according to claim 17

wherein a single stimulation electrode is implanted.

23. A method according to claim 22

wherein applying the stimulation waveforms achieves bilateral stimulation of the left and right branches of the genital dorsal nerves.

24. A method according to claim 17

wherein at least a first stimulation electrode and a second stimulation electrode are implanted.

25. A method according to claim 24

wherein the stimulation waveforms conveyed to the at least a first stimulation electrode affect stimulation of the left and/or right branches of the dorsal genital nerves, and the stimulation waveforms conveyed to the at least a second stimulation electrode affect stimulation of the left and/or right branches of the dorsal genital nerves.