Transobturator lead implantation for pelvic floor stimulation

• US 20070173900A1
• Filed: 01/24/2006
• Published: 07/26/2007
• Est. Priority Date: 01/24/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin, Bonde, Eric, Siegel, Steven
• Granted Patent: US 7,763,034 B2
• Time in Patent Office: Days
• US Class Current: 607/41
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00238 Type of minimally invasive operation A61B2017/00805 takes precedence
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61N 1/02 Details
• 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

Abstract

The disclosure is directed to a method and tool for implanting a stimulation lead or other medical device adjacent a pudendal nerve. The tool includes a shaped needle that enters a patient and passes through an obturator foramen passage in a pelvis. A physician places a tip of the tool at the pudendal nerve and performs test stimulation to confirm an effective stimulation location. A shape memory cannula initially covering the needle remains at the pudendal nerve when the physician removes the tool. The cannula deforms to follow the curve of the pudendal nerve once the needle is removed, and a lead is inserted into the cannula and secured at the pudendal nerve placement site. This method may provide an easier and more consistent procedure for implanting the stimulation lead near the pudendal nerve.

Claims

1. A method for placing an implantable medical device in a pelvis of a patient, the method comprising:

creating a path through an opening in the pelvis, wherein the opening in the pelvis is an obturator foramen; and

placing the implantable medical device via the path so that the implantable medical device is disposed adjacent to a nerve.

2. The method of claim 1, wherein the implantable medical device includes a lead.

3. The method of claim 2, wherein the lead includes one or more electrodes that are disposed adjacent to the nerve.

4. The method of claim 1, wherein the implantable medical device includes a leadless stimulation module.

5. The method of claim 1, wherein the implantable medical device is a drug delivery catheter.

6. The method of claim 1, wherein creating a path includes creating the path with a needle, placing a cannula within the path over the needle, and withdrawing the needle from the cannula to leave the cannula within the path, and wherein placing the implantable medical device includes placing the implantable medical device through the cannula.

7. The method of claim 6, further comprising placing a distal tip of the needle adjacent to a clitoral nerve.

8. The method of claim 6, further comprising placing a distal tip of the needle adjacent to a pudendal nerve.

9. The method of claim 8, wherein placing a distal tip of the needle includes slightly retracting the needle once the needle contacts a sacro-tuborosity ligament beyond the pudendal nerve.

10. The method of claim 6, further comprising imaging the cannula with fluoroscopy to verify placement of a distal end of the cannula adjacent the nerve.

11. The method of claim 6, further comprising delivering electrical stimulation via the needle to verify placement of a distal end of the needle adjacent the nerve.

12. The method of claim 11, further comprising delivering the electrical stimulation from an implant tool coupled to the needle.

13. The method of claim 11, further comprising observing muscle contractions in response to the delivery of electrical stimulation to verify placement of the distal end of the needle adjacent the nerve.

14. The method of claim 11, further comprising utilizing electromyography to observe a sphincter compound muscle action potential to verify placement of the distal end of the needle adjacent the nerve.

15. The method of claim 6, wherein the cannula changes from a first shape to a second shape once the needle is withdrawn from the cannula.

16. The method of claim 15, wherein the second shape of the cannula is shaped to aid in directing the lead towards an ischial spine adjacent to the pudendal nerve.

17. The method of claim 6, further comprising adjusting a position of the needle in response to tactile feedback indicating contact of the needle with anatomical structures within the patient.

18. The method of claim 1, further comprising locating an ischial spine of the pelvis trans-vaginally to aid in directing the needle through the obturator foramen.

19. The method of claim 1, further comprising locating an ischial spine of the pelvis trans-rectally to aid in directing the needle through the obturator foramen.

20. A system for placing an implantable medical device in a pelvis of a patient, the system comprising:

a handle;

a needle, coupled to the handle, for insertion through an obturator foramen of the pelvis; and

a cannula of a first shape having an inner lumen that receives at least a portion of the needle,

wherein the needle is curved to facilitate insertion through the obturator foramen to extend to a nerve within the pelvis.

21. The system of claim 20, wherein the needle is curved and sized so that a distal end of the needle extends to a pudendal nerve.

22. The system of claim 20, wherein the needle is curved and sized so that a distal end of the needle extends to a clitoral nerve.

23. The system of claim 20, wherein the inner lumen of the cannula is sized to accommodate placement of the implantable medical device via the lumen, wherein the implantable medical device includes one of a lead carrying one or more electrodes for electrical stimulation, a leadless electrical stimulation module, or a drug delivery catheter.

24. The system of claim 20, wherein the needle comprises a curve of a radius R, wherein the radius R is in a range of approximately 2 cm to 20 cm.

25. The system of claim 24, wherein the radius R is in a range of approximately 5 cm to 15 cm.

26. The system of claim 20, wherein the needle comprises a helical shape.

27. The system of claim 20, wherein a length of the needle is in a range of approximately 5 cm to 50 cm.

28. The system of claim 27, wherein the length of the needle is in a range of approximately 15 cm to 25 cm.

29. The system of claim 20, wherein the cannula changes from a first shape to a second shape once the needle is withdrawn from the cannula.

30. The system of claim 29, wherein the second shape of the cannula is shaped to aid in directing the lead toward an ischial spine adjacent to the pudendal nerve.

31. The system of claim 20, wherein the handle includes a stimulation pulse generator that delivers electrical stimulation to the needle to verify placement of a distal end of the needle adjacent the nerve.

32. The system of claim 31, wherein the cannula is electrically insulative and the needle is electrically conductive, and the cannula is sized to cover a major portion of the needle and expose a distal portion of the needle to deliver the electrical stimulation.

33. The system of claim 20, wherein the handle is coupled to a stimulation pulse generator that delivers electrical stimulation to the needle via the handle to verify placement of a distal end of the needle adjacent the nerve.

34. A method for placing an implantable lead for an electrical neurostimulator in a pelvis of a patient, the method comprising:

creating a path through an opening in the pelvis with a needle, wherein the opening in the pelvis is an obturator foramen;

placing a cannula over the needle;

introducing the cannula into the path;

withdrawing the needle from the cannula; and

inserting the implantable lead into the cannula so that the implantable medical device is disposed adjacent to a nerve.

35. The method of claim 34, further comprising slightly retracting the needle once the needle contacts a sacro-tuborosity ligament beyond a pudendal nerve.

36. The method of claim 34, further comprising imaging the cannula with fluoroscopy to verify placement of a distal end of the cannula adjacent the nerve.

37. The method of claim 34, wherein the cannula changes from a first shape to a second shape once the needle is withdrawn from the cannula.

38. The method of claim 37, wherein the second shape is shaped to aid in directing the lead toward an ischial spine adjacent to a pudendal the nerve.

39. The method of claim 34, further comprising locating an ischial spine of the pelvis trans-vaginally to aid in directing the needle through the obturator foramen.

40. The method of claim 34, further comprising locating an ischial spine of the pelvis trans-rectally to aid in directing the needle through the obturator foramen.

41. The method of claim 34, further comprising adjusting a position of the needle in response to tactile feedback indicating contact of the needle with anatomical structures within the patient.