Methods and apparatus for renal neuromodulation

• US 8,145,316 B2
• Filed: 07/25/2005
• Issued: 03/27/2012
• Est. Priority Date: 04/08/2002
• Status: Expired due to Fees

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Ardian, Inc. (Medtronic Plc)
• Inventors: Sutton, Douglas, Gifford, III, Hanson, Levin, Howard R., Gelfand, Mark, Clark, Benjamin J., Deem, Mark, Demarais, Denise
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US11/189,563
• Publication Number:
  US 20060041277A1
• Time in Patent Office: 2,437 Days
• Field of Search: 607/40, 607/44, 607/2, 607/116
• US Class Current: 607/44
• 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. A method for renal neuromodulation, the method comprising:

extravascularly positioning an electrode proximate to a renal nerve that innervates a kidney of a human patient diagnosed with at least one of heart failure, hypertension, acute myocardial infarction, impaired renal function, and chronic renal failure; and

delivering an electric field via the electrode that modulates the renal nerve in a manner that significantly improves a measurable physiological parameter corresponding to the diagnosed disease, wherein the electric field reduces neural communication along the renal nerve,

wherein the kidney continues to secrete renin in the patient after delivering the electric field.

2. The method of claim 1, wherein positioning the electrode proximate the renal nerve further comprises positioning the electrode adjacent a renal vasculature.

3. The method of claim 2 further comprising orienting the electric field with a longitudinal dimension of at least one of the renal vasculature and renal nerve.

4. The method of claim 2, 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.

5. The method of claim 4, wherein percutaneously positioning the electrode proximate to the renal nerve of the patient further comprises attaching the electrode to the catheter.

6. The method of claim 4, wherein percutaneously positioning the electrode proximate to the renal nerve of the patient further comprises advancing the electrode through the catheter.

7. The method of claim 1, wherein modulating the renal nerve of the patient further comprises inducing irreversible electroporation in the renal nerve.

8. The method of claim 1, wherein modulating the renal nerve of the patient further comprises at least partially denervating a renal tissue of the patient.

9. The method of claim 8 wherein at least partially denervating the renal tissue of the patient further comprises at least partially denervating at least one kidney of the patient.

10. The method of claim 1 further comprising:

electrically stimulating the renal nerve; and

monitoring a response of the physiological parameter to the stimulation.

11. The method of claim 10, wherein electrically stimulating and monitoring further comprises electrically stimulating and monitoring before delivering the electric field to identify a location suitable for delivering the electric field.

12. The method of claim 10, wherein electrically stimulating and monitoring further comprises electrically stimulating and monitoring after delivering the electric field to determine an extent of modulation of the renal nerve induced by the electric field.

13. The method of claim 1 wherein:

extravascularly positioning the electrode proximate to the renal nerve comprises positioning a pair of bipolar electrodes proximate the renal nerve; and

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

14. The method of claim 1 further comprising infusing an agent to create a working space for extravascularly positioning the electrode proximate to the renal nerve of the patient.

15. The method of claim 1, further comprising electrically coupling the electrode to an electric field generator before delivering an electric field via the electrode to modulate the renal nerve.

16. The method of claim 15, wherein electrically coupling the electrode to the electric field generator comprises positioning the electric field generator external to the patient.

17. The method of claim 15, wherein electrically coupling the electrode to the electric field generator comprises subcutaneously implanting the electric field generator within the patient.

18. The method of claim 15, wherein electrically coupling the electrode to the electric field generator comprises transcutaneously transferring energy from the generator to the electrode.

19. The method of claim 1, wherein extravascularly positioning the electrode proximate to the renal nerve of the patient comprises percutaneously advancing the electrode into position under guidance.

20. The method of claim 19, wherein percutaneously advancing the electrode into position under guidance 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.

21. The method of claim 1, further comprising mechanically creating a working space for extravascularly positioning of the electrode proximate to the renal nerve of the patient.

22. The method of claim 1, wherein extravascularly positioning the electrode comprises percutaneously positioning at least three electrodes proximate to the renal nerve.

23. The method of claim 22 further comprising monitoring with at least one of the electrodes.

24. The method of claim 1 wherein delivering an electric field comprises delivering a pulsed electric field.

25. The method of claim 1 wherein modulating the renal nerve of the patient further comprises delivering thermal energy to the renal nerve.

26. The method of claim 25 wherein delivering thermal energy to the renal nerve comprises heating the renal nerve.

27. The method of claim 26 wherein heating the renal nerve comprises at least partially ablating the renal nerve.

28. The method of claim 1 wherein delivering an electric field further comprises delivering a continuous electric field.

29. The method of claim 1 wherein delivering an energy field further comprises delivering ultrasound energy.

30. The method of claim 1 wherein delivering an energy field further comprises delivering high intensity focused ultrasound.

31. The method of claim 1 wherein delivering an energy field further comprises delivering microwave energy.

32. The method of claim 1 wherein delivering an energy field further comprises delivering radiofrequency energy.

33. The method of claim 1 wherein delivering an electric field that modulates the renal nerve of the patient in a manner that significantly improves a measurable physiological parameter comprises increasing the patient'"'"'s urine production.

34. The method of claim 1 wherein delivering an electric field that modulates the renal nerve of the patient in a manner that significantly improves a measurable physiological parameter comprises decreasing the patient'"'"'s blood pressure.

35. The method of claim 1 wherein delivering an electric field that modulates the renal nerve of the patient in a manner that significantly improves a measurable physiological parameter comprises decreasing the patient'"'"'s fluid retention level.

36. The method of claim 1 wherein delivering an electric field that modulates the renal nerve of the patient in a manner that significantly improves a measurable physiological parameter comprises decreasing the patient'"'"'s renin secretion.

37. The method of claim 1 wherein delivering an electric field that modulates the renal nerve of the patient in a manner that significantly improves a measurable physiological parameter comprises increasing the patient'"'"'s renal blood flow.

38. The method of claim 1 wherein delivering an electric field that modulates the renal nerve of the patient in a manner that significantly improves a measurable physiological parameter comprises increasing the patient'"'"'s waste excretion.

39. The method of claim 1 wherein delivering an electric field that modulates the renal nerve of the patient in a manner that significantly improves a measurable physiological parameter comprises decreasing the patient'"'"'s sodium retention.

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

percutaneously advancing an electrode under Computed Tomography-guidance until the electrode is extravascularly located proximate to post-ganglionic neural fibers that innervate a kidney of a human patient; and

Delivering an electric field via the electrode that modulates the neural fibers in a manner that significantly improves a measurable physiological parameter corresponding to at least one of heart failure hypertension, acute myocardial infarction, impaired renal function, and chronic renal failure,

wherein the kidney continues to secrete renin in the patient after delivering the electric field.

41. A method for treatment of a human patient via renal denervation, the method comprising:

percutaneously positioning a renal denervation probe having an electrode proximate to a renal nerve that innervates a kidney of a human patient diagnosed with at least one of heart failure, hypertension, acute myocardial infarction, impaired renal function, and chronic renal failure; and

delivering an electric field via the electrode that modulates the renal nerve in a manner that significantly improves a measurable physiological parameter corresponding to the diagnosed disease, wherein the electric field reduces neural communication along the renal nerve,

wherein the kidney continues to secrete renin in the patient after delivering the electric field.