Stimulation of dorsal genital nerves to treat urologic dysfunctions

• US 8,467,875 B2
• Filed: 03/28/2007
• Issued: 06/18/2013
• Est. Priority Date: 02/12/2004
• Status: Active Grant

• Current Assignee: Medtronic Urinary Solutions, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Grill, Julie, Mrva, Joseph J, Strother, Robert B, Thrope, Geoffrey B, Bennett, Maria E, Lechman, Tina E, Sakai, Jonathan L, Zmina, Therese M
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): BEHRINGER, LUTHER G
• Application Number:
  US11/729,333
• Publication Number:
  US 20070239224A1
• Time in Patent Office: 2,274 Days
• Field of Search: 607 39- 41
• US Class Current: 607/41
• CPC Class Codes: A61N 1/0524 Vaginal electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators

Abstract

Systems and methods treat urologic dysfunctions by implanting a lead and electrode in a tissue region affecting urologic function, and implanting a pulse generator in an anterior pelvic region remote from the electrode. Bilateral stimulation of the left and/or right branches of the dorsal genital nerves using a single lead implanted in adipose or other tissue in the region at or near the pubic symphysis is able to treat urinary incontinence.

Claims

1. A method comprising:

creating a first incision near-midline over a pubic symphysis of a patient,

inserting a distal portion of a lead through the first incision, wherein the lead includes the distal portion and a proximal portion, the distal portion including at least one stimulation electrode, wherein the distal portion is inserted through the first incision to position the at least one stimulation electrode at a target site at the pubic symphysis,

creating a second incision remote from the first incision,

tunneling the proximal portion of the lead between the first incision and the second incision,

coupling the lead to a pulse generator,

delivering electrical stimulation from the pulse generator to the patient via the at least one stimulation electrode, wherein the electrical stimulation and target site are selected to bilaterally stimulate the left branch and right branch of a dorsal genital nerve of the patient, and

wherein the at least one stimulation electrode is located such that the electrical stimulation bilaterally stimulates the left branch and right branch of the dorsal genital nerve substantially simultaneously.

2. A method according to claim 1, further including implanting the pulse generator in the second incision.

3. A method according to claim 1, wherein the second incision is located in an anterior pelvic region.

4. A method according to claim 1, wherein the stimulation electrode is sized and configured to be implanted in adipose tissue.

5. A method according to claim 1, wherein the distal portion of the lead includes at least one visual marker.

6. A method according to claim 1, wherein the distal portion of the lead includes a flexible anchoring structure comprising an array of expandable shovel-like paddles.

7. A method according to claim 6, wherein the shovel-like paddles define a scalloped shape.

8. A method according to claim 1, wherein the pulse generator includes a larger end and a smaller end and allows the smaller end of the case to be placed into the second incision first, with the larger end being pushed in last.

9. The method of claim 1, wherein the at least one stimulation electrode comprises a first stimulation electrode, wherein delivering the electrical stimulation from the pulse generator to the patient via the at least one stimulation electrode comprises delivering unipolar electrical stimulation to the patient via the first stimulation electrode.

10. The method of claim 1, wherein the at least one stimulation electrode comprises a first stimulation electrode and a second stimulation electrode, wherein delivering the electrical stimulation from the pulse generator to the patient via the at least one stimulation electrode comprises delivering bipolar electrical stimulation to the patient via the first stimulation electrode and the second stimulation electrode.

11. The method of claim 1, wherein the at least one stimulation electrode comprises a first stimulation electrode and a second stimulation electrode, wherein the lead includes a first lead including the first stimulation electrode and a second lead including the second stimulation electrode, and wherein delivering electrical stimulation from the pulse generator to the patient via the at least one stimulation electrode comprises delivering electrical stimulation from the pulse generator to the patient via at least one of the first stimulation electrode and the second stimulation electrode.

12. The method of claim 1, wherein the at least one stimulation electrode is located in adipose tissue of the patient.

13. The method of claim 1, wherein the pulse generator includes a rechargeable battery and a power receiving coil coupled to the rechargeable battery, wherein the power receiving coil is configured to transcutaneously receive an externally generated radio frequency magnetic field to recharge the rechargeable battery.

14. The method of claim 1, wherein the pulse generator comprises an implantable pulse generator.

15. A method comprising:

implanting a stimulation electrode at a target site at a pubic symphysis of a patient,

coupling the stimulation electrode to a pulse generator configured to generate electrical stimulation, and

activating the pulse generator to deliver the electrical stimulation to the patient via the stimulation electrode, wherein the electrical stimulation and target site are selected to bilaterally stimulate the left branch and right branch of a dorsal genital nerve of the patient.

16. A method according to claim 15, wherein implanting the stimulation electrode at the target site at the pubic symphysis comprises implanting the stimulation electrode at the target site at the pubic symphysis without fluoroscopy.

17. A method according to claim 15, wherein the method is performed without urodynamics.

18. A method according to claim 15, wherein the stimulation electrode further comprises a lead comprising a proximal portion and a distal portion, the distal portion including the stimulation electrode and at least one visual marker, and implanting the stimulation electrode further includes visually observing the lead marker for desired electrode placement.

19. A method according to claim 15, further including requesting feedback from the patient about sensations felt during the implant as a result of applying electrical stimulation.

20. The method of claim 15, wherein delivering the electrical stimulation from the pulse generator to the patient via the stimulation electrode comprises delivering unipolar electrical stimulation to the patient via the stimulation electrode.

21. The method of claim 15, wherein the stimulation electrode comprises a first stimulation electrode, wherein the lead comprises a first lead including the first stimulation electrode, wherein a second lead including a second stimulation electrode is coupled to the pulse generator, and wherein delivering electrical stimulation from the pulse generator to the patient via the stimulation electrode comprises delivering electrical stimulation from the pulse generator to the patient via at least one of the first stimulation electrode and the second stimulation electrode.

22. The method of claim 15, wherein the stimulation electrode is located in adipose tissue of the patient.

23. The method of claim 15, wherein the stimulation electrode is located such that the electrical stimulation stimulates the left branch and right branch of the dorsal genital nerve substantially simultaneously.

24. The method of claim 15, wherein the pulse generator includes a rechargeable battery and a power receiving coil coupled to the rechargeable battery, wherein the power receiving coil is configured to transcutaneously receive an externally generated radio frequency magnetic field to recharge the rechargeable battery.

25. The method of claim 15, wherein the pulse generator comprises an implantable pulse generator.

26. The method of claim 15, wherein delivering electrical stimulation from the pulse generator to the patient via the stimulation electrode comprises delivering unipolar electrical stimulation from the pulse generator to the patient via the stimulation electrode, and wherein the stimulation electrode is located such that the electrical stimulation bilaterally stimulates the left branch and right branch of the dorsal genital nerve substantially simultaneously.

27. The method of claim 15, wherein delivering electrical stimulation from the pulse generator to the patient via the stimulation electrode comprises delivering bipolar electrical stimulation from the pulse generator to the patient via the stimulation electrode and wherein the stimulation electrode is located such that the electrical stimulation bilaterally stimulates the left branch and right branch of the dorsal genital nerve substantially simultaneously.

28. A method comprising:

generating electrical stimulation via a pulse generator; and

delivering the electrical stimulation from the pulse generator to a patient via at least one stimulation electrode located at a target site at a pubic symphysis of the patient, wherein the electrical stimulation and the target site are selected to bilaterally stimulate the left branch and right branch of a dorsal genital nerve of the patient.

29. The method of claim 28, wherein the at least one stimulation electrode comprises a first stimulation electrode, wherein delivering the electrical stimulation from the pulse generator to the patient via the at least one stimulation electrode comprises delivering unipolar electrical stimulation to the patient via the first stimulation electrode.

30. The method of claim 28, wherein the at least one stimulation electrode comprises a first stimulation electrode and a second stimulation electrode, wherein delivering the electrical stimulation from the pulse generator to the patient via the at least one stimulation electrode comprises delivering bipolar electrical stimulation to the patient via the first stimulation electrode and the second stimulation electrode.

31. The method of claim 28, wherein the at least one stimulation electrode comprises a first stimulation electrode and a second stimulation electrode, wherein the lead includes a first lead including the first stimulation electrode and a second lead including the second stimulation electrode, and wherein delivering electrical stimulation from the pulse generator to the patient via the at least one stimulation electrode comprises delivering electrical stimulation from the pulse generator to the patient via at least one of the first stimulation electrode and the second stimulation electrode.

32. The method of claim 28, wherein the at least one stimulation electrode is located in adipose tissue of the patient.

33. The method of claim 28, wherein the at least one stimulation electrode is located such that the electrical stimulation stimulates the left branch and right branch of the dorsal genital nerve substantially simultaneously.

34. The method of claim 28, wherein the implantable pulse generator includes a rechargeable battery and a power receiving coil coupled to the rechargeable battery, and wherein the power receiving coil configured to transcutaneously receive an externally generated radio frequency magnetic field to recharge the rechargeable battery.

35. The method of claim 28, wherein the pulse generator comprises an implantable pulse generator.

36. The method of claim 28, wherein delivering electrical stimulation from the pulse generator to the patient via the at least one stimulation electrode comprises delivering unipolar electrical stimulation from the pulse generator to the patient via the at least one stimulation electrode, and wherein the electrical stimulation stimulates the left branch and right branch of the dorsal genital nerve substantially simultaneously.

37. The method of claim 28, wherein delivering electrical stimulation from the pulse generator to the patient via the at least one stimulation electrode comprises delivering bipolar electrical stimulation from the pulse generator to the patient via the at least one stimulation electrode, and wherein the electrical stimulation stimulates the left branch and right branch of the dorsal genital nerve substantially simultaneously.