Techniques for placing medical leads for electrical stimulation of nerve tissue

• US 9,572,982 B2
• Filed: 04/30/2009
• Issued: 02/21/2017
• Est. Priority Date: 04/30/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Burnes, John E., Gardeski, Kenneth C., Klepfer, Ruth N., Macaulay, Patrick E., Morris, Mary M., Scheiner, Avram
• Primary Examiner(s): Nguyen, Tuan V
• Assistant Examiner(s): EVERAGE, KEVIN D
• Application Number:
  US12/433,766
• Publication Number:
  US 20090275956A1
• Time in Patent Office: 2,854 Days
• Field of Search: 606/129, 600/301, 600/345, 600/372, 600/381, 600/483, 600/485, 600/493, 600/505
• US Class Current: 1/1
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• 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 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36128 Control systems

Abstract

This disclosure is directed to extra, intra, and transvascular medical lead placement techniques for arranging medical leads and electrical stimulation and/or sensing electrodes proximate nerve tissue within a patient.

Claims

1. A method for locating a stimulation electrode within a blood vessel, the method comprising:

deploying a delivery catheter through a lumen of the blood vessel to a location proximate a target nerve tissue site outside the blood vessel;

advancing the stimulation electrode from within the deployed delivery catheter and into the blood vessel lumen toward the nerve tissue; and

detecting relative positions of the nerve tissue outside the blood vessel and the advanced electrode within the blood vessel lumen by means of a sensor connected to the delivery catheter.

2. The method of claim 1, wherein the sensor measures blood pressure within the blood vessel, and further comprising energizing the advanced electrode prior to measuring the blood pressure, the measured blood pressure indicating whether or not the advanced electrode is positioned relative to the nerve tissue for effective stimulation thereof.

3. The method of claim 1, further comprising anchoring the advanced electrode to a wall of the blood vessel lumen adjacent the nerve tissue.

4. The method of claim 3, further comprising removing the delivery catheter and the sensor from the blood vessel lumen while leaving the advanced electrode anchored to the wall of the blood vessel lumen.

5. The method of claim 1, wherein the nerve tissue comprises one of a vagus nerve, a hypoglossal nerve, a nerve plexus, nerve ganglia, or a vascular baroreceptor.

6. The method of claim 1, wherein the sensor is included in an imaging system to generate an image in which the relative positions of the nerve tissue and the advanced electrode can be discerned.

7. The method of claim 1, wherein advancing the stimulation electrode comprises extending a tubular member out from an aperture formed in a sidewall of the delivery catheter, the electrode being received within a lumen of the tubular member.

8. The method of claim 7, wherein advancing the stimulation electrode further comprises advancing a lead, which includes the electrode, along a guidewire that is received in the lumen of the tubular member.

9. The method of claim 7, wherein the sensor comprises a sensor on an external surface of the tubular member towards a distal end of the tubular member.

10. The method of claim 7, wherein the sensor comprises a sensor on an external surface of the delivery catheter between a distal end of the catheter and a location along the catheter from which the tubular member is extendable and retractable.

11. The method of claim 1, wherein advancing the stimulation electrode comprises advancing a guidewire, along which the electrode is advanceable, out from an aperture formed in a sidewall of the delivery catheter;

and further comprising anchoring the guidewire to the wall of the blood vessel lumen after advancing the stimulation electrode.

12. The method of claim 1, wherein the sensor comprises a sensor on an external surface of the delivery catheter towards a distal end of the delivery catheter.

13. The method of claim 1,

wherein the stimulation electrode comprises a stimulation electrode on a lead, and

wherein advancing the stimulation electrode from within the deployed delivery catheter and into the blood vessel lumen toward the nerve tissue includes advancing a distal end of the lead from within the deployed delivery catheter and into the blood vessel lumen toward the nerve tissue.

14. The method of claim 13, wherein advancing the distal end of the lead from within the deployed delivery catheter and into the blood vessel lumen toward the nerve tissue includes advancing the distal end of the lead from a distal end of the catheter toward a wall of the blood vessel lumen to position the stimulation electrode adjacent the nerve tissue.

15. The method of claim 14, wherein advancing the stimulation electrode comprises extending a guide member from within the deployed delivery catheter toward a wall of the blood vessel lumen, and advancing the lead along the guide member.

16. The method of claim 15, wherein a distal end of the guide member comprises an anchor, the method further comprising attaching the anchor to the wall of the blood vessel lumen.

17. The method of claim 16, wherein the anchor comprises the distal end of the guide member formed in a spiral shape configured to screw into the wall of the blood vessel lumen.

18. The method of claim 14, wherein the sensor comprises a sensor on an external surface of the delivery catheter towards a distal end of the delivery catheter.

19. The method of claim 1, wherein the sensor comprises part of an intravascular imaging system.

20. The method of claim 1, wherein the sensor comprises part of an intravascular ultrasound imaging system.

21. The method of claim 1, further comprising:

energizing the advanced electrode; and

measuring, with the sensor, blood pressure within the blood vessel after energizing the electrode, the measured blood pressure indicating whether or not the advanced electrode is positioned relative to the nerve tissue for effective stimulation thereof.

22. A method for implanting a pair of stimulation electrodes, the method comprising:

deploying a delivery catheter through a lumen of a blood vessel to a location proximate a target nerve tissue site outside the blood vessel;

advancing a first electrode of the pair of stimulation electrodes from within the deployed delivery catheter and into the blood vessel lumen toward the nerve tissue;

energizing the advanced, first electrode;

detecting relative positions of the nerve tissue outside the blood vessel and the advanced, first electrode within the blood vessel by means of a sensor connected to the delivery catheter, the sensor measuring blood pressure within the blood vessel after energizing the electrode, and the measured blood pressure indicating whether or not the advanced, first electrode is positioned relative to the nerve tissue for effective stimulation thereof;

chronically deploying the advanced, first electrode within the blood vessel lumen adjacent the nerve tissue if the measured blood pressure indicates that the advanced, first electrode is positioned for effective stimulation of the nerve tissue; and

arranging a second electrode of the pair of electrodes adjacent the nerve tissue such that the pair of stimulation electrodes are arranged in flanking, non-contacting relationship with the nerve tissue.

23. The method of claim 22, further comprising anchoring the advanced, first electrode to a wall of the blood vessel lumen adjacent the nerve tissue.

24. The method of claim 23, further comprising removing the delivery catheter and the sensor from the blood vessel lumen while leaving the advanced, first electrode anchored to the wall of the blood vessel lumen.

25. The method of claim 22, wherein advancing the first electrode of the pair of stimulation electrodes comprises extending a tubular member out from an aperture formed in a sidewall of the delivery catheter, the first electrode being received within a lumen of the tubular member.

26. The method of claim 25, wherein advancing the first electrode further comprises advancing a lead, which includes the first electrode, over a guidewire that is received in the lumen of the tubular member.

27. The method of claim 25, wherein the sensor comprises a sensor on an external surface of the tubular member towards a distal end of the tubular member.

28. The method of claim 25, wherein the sensor comprises a sensor on an external surface of the delivery catheter between a distal end of the catheter and a location along the catheter from which the tubular member is extendable and retractable.

29. The method of claim 22, wherein advancing the first electrode of the pair of stimulation electrodes comprises advancing a guidewire out from an aperture formed in a sidewall of the delivery catheter, along which the electrode is advanceable;

and further comprising anchoring the guidewire to the wall of the blood vessel lumen after advancing the first electrode.

30. The method of claim 22, wherein the sensor comprises a sensor on an external surface of the delivery catheter towards a distal end of the delivery catheter.

31. The method of claim 22,

wherein the first electrode comprises a first electrode on a lead, and

wherein advancing the first electrode from within the deployed delivery catheter and into the blood vessel lumen toward the nerve tissue includes advancing a distal end of the lead from within the deployed delivery catheter and into the blood vessel lumen toward the nerve tissue.

32. The method of claim 31, wherein advancing the distal end of the lead from within the deployed delivery catheter and into the blood vessel lumen toward the nervetissue includes advancing the distal end of the lead from a distal end of the catheter toward a wall of the blood vessel lumen to position the first electrode adjacent the nerve tissue.

33. The method of claim 32, wherein advancing the first electrode comprises extending a guide member from within the deployed delivery catheter toward a wall of the blood vessel lumen, and advancing the lead along the guide member.

34. The method of claim 32, wherein the sensor comprises a sensor on an external surface of the delivery catheter towards a distal end of the delivery catheter.