IP Library Granted Patent US 9,125,661
Granted Patent B2
US 9,125,661 · App. 14/056,888 · Granted Sep 8, 2015

Methods and apparatus for renal neuromodulation

Inventors: Mark E. Deem (Mountain View, CA); Hanson Gifford, III (Woodside, CA); Denise Zarins (Saratoga, CA); Douglas Sutton (Pacifica, CA); Erik Thai (San Jose, CA); Mark Gelfand (New York, NY); Howard R. Levin (Teaneck, NJ)
Assignee: Medtronic Ardian Luxembourg S.a.r.l.
A61B18/1233A61B18/1492A61B18/18A61M5/14A61N1/0412A61N1/05A61N1/327A61N1/3606A61N1/36017A61N5/00A61B2018/00214A61B2018/00404A61B2018/00434A61B2018/00505A61B2018/00511A61B2018/00613A61N1/326A61N2007/003
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Quick Facts
Patent No.
US 9,125,661
App. No.
14/056,888
Granted
Sep 8, 2015
Kind
B2
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 percutaneous intravascular delivery of pulsed electric fields to achieve such neuromodulation.

Claims (29)

1. A method of performing renal neuromodulation, the method comprising:

passing a catheter comprising a single electrode through vasculature of a human patient to a renal blood vessel and proximate to neural fibers that innervate a kidney of the patient; and

delivering radio frequency (RF) energy to the neural fibers via the electrode, wherein the RF energy ablates the neural fibers to reduce renal sympathetic nerve activity of the patient,

wherein ablating the neural fibers that innervate the kidney of the patient results in a therapeutically beneficial reduction in blood pressure of the patient.

2. The method of claim 1 wherein the single electrode comprises a tip electrode.

3. The method of claim 1 wherein the single electrode is configured to contact, but not pass through, a wall of the renal blood vessel.

4. The method of claim 1 , further comprising attaching an external ground pad to an exterior of the patient,

wherein delivering RF energy via the electrode comprises delivering the RF energy in a monopolar fashion between the electrode and the external ground pad.

5. The method of claim 1 wherein intravascularly delivering a catheter through vasculature of the patient comprises intravascularly delivering the catheter through an aorta to a renal artery of the patient via a guide catheter.

6. The method of claim 1 , further comprising monitoring a parameter of the electrode and/or tissue proximate to the neural fibers within the patient during therapy.

7. The method of claim 6 wherein monitoring a parameter comprises monitoring impedance and/or temperature.

8. The method of claim 6 , further comprising controlling the delivery of RF energy to the neural fibers in response to the monitored parameter.

9. The method of claim 1 wherein delivering RF energy to the neural fibers comprises thermally altering the neural fibers in a manner that reduces neural traffic to and from the kidney.

10. The method of claim 1 wherein delivering RF energy to the neural fibers comprises partially ablating the neural fibers of the patient.

11. The method of claim 1 wherein delivering RF energy to the neural fibers comprises at least partially blocking afferent and efferent neural traffic to and/or from the kidney of the patient.

12. The method of claim 1 wherein delivering RF energy to the neural fibers via the electrode comprises delivering energy at a first treatment site along the renal blood vessel, and wherein the method further comprises:

repositioning the electrode at a second treatment site within the renal blood vessel after delivering RF energy at the first treatment site; and

after repositioning, energizing the electrode to deliver RF energy to neural fibers at the second treatment site along the renal blood vessel.

13. A method for catheter-based renal denervation, the method comprising:

intravascularly positioning a renal denervation catheter comprising an elongated flexible shaft and a single tip electrode within a renal blood vessel of a human patient, wherein the tip electrode is configured to physically contact a target wall region within the renal blood vessel of the patient; and

ablating nerves that innervate a kidney of the patient via radio frequency (RF) energy from the electrode positioned within the renal blood vessel, wherein ablating nerves that innervate a kidney of the patient results in a therapeutically beneficial reduction in blood pressure of the patient.

14. The method of claim 13 wherein intravascularly positioning a renal denervation catheter within a renal blood vessel of a human patient comprises intravascularly positioning the renal denervation catheter within a renal artery of the patient.

15. The method of claim 13 wherein ablating nerves that innervate a kidney of the patient further comprises systemically reducing sympathetic tone in the patient.

16. The method of claim 13 wherein ablating nerves that innervate a kidney of the patient comprises ablating at least one of an efferent nerve and an afferent nerve via the electrode.

17. The method of claim 13 wherein ablating nerves that innervate a kidney of the patient comprises at least partially denervating the kidney.

18. The method of claim 13 wherein the renal denervation catheter further comprises a sensor proximate to the electrode and configured to monitor at least one of temperature and impedance, and wherein the method further comprises controlling ablation of the nerves based, at least in part, on monitored temperature and/or impedance.

19. The method of claim 13 wherein ablating nerves that innervate a kidney of the patient further results in a therapeutically beneficial reduction in central sympathetic overactivity of the patient.

20. The method of claim 13 wherein ablating nerves that innervate a kidney of the patient further results in a therapeutically beneficial reduction in clinical symptoms of heart failure in the patient.

21. The method of claim 13 , further comprising removing the renal denervation catheter from the patient after ablating the nerves.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 13, 2014
From: DEEM, MARK; GIFFORD, HANSON, III; DEMARAIS, DENISE; SUTTON, DOUGLAS; THAI, ERIK; GELFAND, MARK; LEVIN, HOWARD R.
To: ARDIAN, INC.
Reel/Frame 032434/0853 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 13, 2014
From: MEDTRONIC ARDIAN LLC
To: MEDTRONIC ARDIAN LUXEMBOURG S.A.R.L.
Reel/Frame 032434/0888 →
CHANGE OF NAME Recorded Mar 13, 2014
From: ARDIAN, INC.
To: MEDTRONIC ARDIAN LLC
Reel/Frame 032447/0701 →
Continuity (12)
Continuation 13930863 · Jun 28, 2013
Continuation 13619851 · Sep 14, 2012
Continuation 12777892 · May 11, 2010
Continuation 11782451 · Jul 24, 2007
Division 11129765 · May 13, 2005
Continuation In Part 10408665 · Apr 8, 2003
Provisional Application 60616254 · Oct 5, 2004
Provisional Application 60624793 · Nov 2, 2004
Provisional Application 60370190 · Apr 8, 2002
Provisional Application 60415575 · Oct 3, 2002
Provisional Application 60442970 · Jan 29, 2003
Related Publication 20140081259A1 · Mar 20, 2014