Methods and apparatus for renal neuromodulation

• US 20060041277A1
• Filed: 07/25/2005
• Published: 02/23/2006
• Est. Priority Date: 04/08/2002
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Levin, Howard R., Demarais, Denise, Gelfand, Mark, Clark, Benjamin J., Gifford, Hanson III, Sutton, Douglas, Deem, Mark
• Granted Patent: US 8,145,316 B2
• Time in Patent Office: Days
• US Class Current: 607/3
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 5/00 : Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00

Abstract

Methods and apparatus are provided for renal neuromodulation using a pulsed electric field to effectuate electroporation or electrofusion. It is expected that renal neuromodulation (e.g., denervation) may, among other things, reduce expansion of an acute myocardial infarction, reduce or prevent the onset of morphological changes that are affiliated with congestive heart failure, and/or be efficacious in the treatment of end stage renal disease. Embodiments of the present invention are configured for extravascular delivery of pulsed electric fields to achieve such neuromodulation.

Claims

1. Apparatus for renal neuromodulation, the apparatus comprising:

a pulsed electric field generator; and

an electrode configured for extravascular placement proximate a renal nerve in a patient,

wherein the electrode is electrically coupled to the pulsed electric field generator for delivering a pulsed electric field to the renal nerve while the electrode is located proximate the renal nerve.

2. The apparatus of claim 1, wherein the electrode is configured for placement adjacent to a renal vasculature.

3. The apparatus of claim 2, wherein the electrode is configured for percutaneous placement adjacent to the renal vasculature.

4. The apparatus of claim 2, wherein the electrode is configured to be arranged in (a) a reduced delivery configuration for placement adjacent to the renal vasculature and (b) an expanded treatment configuration for delivering the pulsed electric field to the renal nerve.

5. The apparatus of claim 4, wherein the electrode is configured to at least partially encircle the renal vasculature in the expanded treatment configuration.

6. The apparatus of claim 1, wherein the electrode is configured to at least partially encircle a renal artery of the patient.

7. The apparatus of claim 2, wherein the electrode is configured for placement in an annular space between renal fascia and renal vasculature.

8. The apparatus of claim 2, wherein the apparatus is configured to orient a longitudinal portion of the pulsed electric field with a longitudinal dimension of at least one of the renal nerve and the renal vasculature.

9. The apparatus of claim 1, wherein the electrode comprises a bipolar electrode pair.

10. The apparatus of claim 1, wherein the electrode comprises an active electrode, and wherein the apparatus further comprises a ground electrode located remote the renal nerve, such that the active electrode is configured to deliver the pulsed electric field to the renal nerve in a monopolar fashion.

11. The apparatus of claim 10, wherein the ground electrode is configured for exterior attachment to the patient.

12. The apparatus of claim 1, wherein the pulsed electric field generator is configured to produce a pulsed electric field that induces irreversible electroporation in the renal nerve.

13. The apparatus of claim 1, wherein the pulsed electric field generator is configured to produce a pulsed electric field that induces electrofusion in the renal nerve.

14. The apparatus of claim 1, wherein the electrode and the pulsed electric field generator are further configured to deliver a stimulation electric field to the renal nerve.

15. The apparatus of claim 1, wherein the device comprises an element for monitoring the response of at least one physiological parameter to stimulation of the renal nerve.

16. The apparatus of claim 15, wherein the element is chosen from the group consisting of ultrasound sensors, electrodes, thermocouples, pressure sensors, imaging modalities, electrical impedence sensors and combinations thereof.

17. The apparatus of claim 1, wherein the electrode is chosen from the group consisting of basket-shaped electrodes, cup-shaped electrodes, spiral electrodes, helical electrodes, ring electrodes, cuff electrodes, fan-shaped electrodes, space-occupying electrodes, undulating electrodes, sinusoidal electrodes, coil electrodes, wire electrodes, arcuate electrodes, concave electrodes, curved electrodes, ribbon electrodes, braid electrodes, composite electrodes, expandable electrodes and combinations thereof.

18. The apparatus of claim 1, wherein the apparatus further comprises an infusion element configured to create a working space to facilitate placement of the electrode.

19. The apparatus of claim 1 further comprising an implanted subcutaneous element electrically coupled to the electrode via tunneled leads.

20. The apparatus of claim 19, wherein the implanted subcutaneous element comprises a subcutaneous electrical contact, the apparatus further comprising a transcutaneous probe electrically coupled to the pulsed electric field generator and configured for reversible placement across skin of the patient for electrically coupling the transcutaneous probe to the subcutaneous electrical contact.

21. The apparatus of claim 19, wherein the implanted subcutaneous element comprises a transcutaneous energy transfer receiving element, the apparatus further comprising a transcutaneous energy transfer transmission element electrically coupled to the pulse electric field generator and configured to non-invasively transmit energy transcutaneously to the receiving element.

22. The apparatus of claim 19, wherein the implanted subcutaneous element comprises the pulsed electric field generator.

23. The apparatus of claim 22, wherein the implanted subcutaneous element further comprises an energy storage device electrically coupled to the pulsed electric field generator.

24. The apparatus of claim 23, wherein the energy storage device is configured for recharging.

25. The apparatus of claim 24 further comprising an external charger configured to transcutaneously recharge the energy storage device.

26. The apparatus of claim 23, wherein the implanted subcutaneous element further comprises a controller.

27. The apparatus of claim 26, wherein the controller further comprises a programmable controller.

28. The apparatus of claim 27 further comprising an external programmer configured to transcutaneously program the controller.

29. The apparatus of claim 1 further comprising a probe configured for percutaneous insertion in proximity to the renal nerve under guidance.

30. The apparatus of claim 29, wherein the guidance comprises guidance chosen from the group consisting of visual, computed tomographic, radiographic, ultrasonic, angiographic, laparoscopic and combinations thereof.

31. The apparatus of claim 29, wherein the probe is electrically coupled to the pulsed electric field generator, and wherein the electrode is attached to the probe.

32. The apparatus of claim 29, wherein the electrode is configured for extravascular placement through the probe proximate the renal nerve.

33. The apparatus of claim 29, wherein the probe is chosen from the group consisting of needles, trocars and combinations thereof.

34. The apparatus of claim 29 further comprising a catheter configured for advancement through the probe, wherein the electrode is attached to the catheter.

60. The apparatus of claim 1, wherein the apparatus further comprises a mechanical element configured to create a working space to facilitate placement of the electrode.

61. The apparatus of claim 1, wherein the electrode further comprises at least three electrodes.

62. The apparatus of claim 61, wherein at least one of the electrodes is configured for monitoring.

35. A method for renal neuromodulation, the method comprising:

percutaneously positioning an electrode proximate to a renal nerve of a patient; and

delivering a pulsed electric field via the electrode to modulate the renal nerve.

36. The method of claim 35, wherein positioning the electrode proximate the renal nerve further comprises positioning the electrode adjacent a renal vasculature.

37. The method of claim 35, wherein modulating the renal nerve of the patient further comprises inducing irreversible electroporation in the renal nerve.

38. The method of claim 35, wherein modulating the renal nerve of the patient further comprises denervating the renal nerve.

39. The method of claim 35 further comprising:

electrically stimulating the renal nerve; and

monitoring a response of a physiological parameter to the stimulation.

40. The method of claim 39, wherein electrically stimulating and monitoring further comprises electrically stimulating and monitoring before delivering the pulsed electric field in order to identify a location suitable for delivering the pulsed electric field.

41. The method of claim 39, wherein electrically stimulating and monitoring further comprises electrically stimulating and monitoring after delivering the pulsed electric field in order to determine an extent of modulation of the renal nerve induced by the pulsed electric field.

42. The method of claim 35, wherein positioning the electrode proximate the renal nerve further comprises positioning a pair of bipolar electrodes proximate the renal nerve;

and

wherein delivering the pulsed electric field via the electrode further comprises delivering the pulsed electric field across the pair of bipolar electrodes.

43. The method of claim 36 further comprising orienting the pulsed electric field with a longitudinal dimension of at least one of the renal vasculature and renal nerve.

44. The method of claim 35 further comprising infusing an agent to create a working space for percutaneously positioning the electrode proximate to the renal nerve of the patient.

45. The method of claim 35 further comprising infusing an agent to protect or repair non-target cells from effects of the pulsed electric field.

46. The method of claim 37 further comprising infusing an agent to alter the susceptibility of cells to electroporation.

47. The method of claim 35 further comprising protecting or repairing non-target cells from effects of the pulsed electric field.

48. The method of claim 35, wherein modulating the renal nerve of the patient further comprises inducing electrofusion in the renal nerve.

49. The method of claim 36 further comprising percutaneously positioning a catheter in an annular space between a renal fascia and the renal vasculature of the patient;

and advancing the catheter through the annular space to bluntly dissect the fascia from the vasculature.

50. The method of claim 49, wherein percutaneously positioning the electrode proximate to the renal nerve of the patient further comprises attaching the electrode to the catheter.

51. The method of claim 49, wherein percutaneously positioning the electrode proximate to the renal nerve of the patient further comprises advancing the electrode through the catheter.

52. The method of claim 35, wherein delivering a pulsed electric field via the electrode to modulate the renal nerve further comprising electrically coupling the electrode to a pulsed electric field generator.

53. The method of claim 52, wherein electrically coupling the electrode to the pulsed electric field generator further comprises positioning the pulsed electric field generator external to the patient.

54. The method of claim 52, wherein electrically coupling the electrode to the pulsed electric field generator further comprises subcutaneously implanting the pulsed electric field generator within the patient.

55. The method of claim 52, wherein electrically coupling the electrode to the pulsed electric field generator further comprises transcutaneously transferring energy from the generator to the electrode.

56. The method of claim 35, wherein percutaneously positioning the electrode proximate to the renal nerve of the patient further comprises percutaneously advancing the electrode into position under guidance.

57. The method of claim 56, wherein percutaneously advancing the electrode into position under guidance further comprises percutaneously advancing the electrode into position under guidance chosen from the group consisting of visual, computed tomographic, radiographic, ultrasonic, angiographic, laparoscopic and combinations thereof.

63. The method of claim 35 further comprising mechanically creating a working space for percutaneous positioning of the electrode proximate to the renal nerve of the patient.

64. The method of claim 35, wherein percutaneously positioning the electrode further comprises percutaneously positioning at least three electrodes proximate to the renal nerve.

65. The method of claim 64 further comprising monitoring with at least one of the electrodes.

58. Apparatus for renal neuromodulation, the apparatus comprising:

a pulsed electric field generator; and

a device configured for percutaneous placement under Computed Tomography-guidance at an extravascular location within a patient proximate to a sympathetic neural path associated with renal function, wherein the device comprises an electrode electrically coupled to the pulsed electric field generator for delivering a pulsed electric field to the sympathetic neural path while the device is at the extravascular location.

59. A method for renal neuromodulation, comprising:

percutaneously advancing an electrode under Computed Tomography-guidance until the electrode is extravascularly located proximate to a sympathetic neural path associated with renal function; and

delivering a pulsed electric field via the electrode to modulate neural activity along the sympathetic path.