IP Library Granted Patent US 9,439,726
Granted Patent B2
US 9,439,726 · App. 15/069,830 · Granted Sep 13, 2016

Methods for therapeutic renal neuromodulation

Inventors: Denise Zarins (Saratoga, CA); Hanson Gifford, III (Woodside, CA); Mark Deem (Mountain View, CA); Douglas Sutton (Pacifica, CA); Howard R. Levin (Teaneck, NJ); Mark Gelfand (New York, NY)
Assignee: Medtronic Ardian Luxembourg S.a.r.l.
A61B18/1492A61B2018/00351A61B2018/00434A61B2018/00511A61B2018/00577
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 9,439,726
App. No.
15/069,830
Granted
Sep 13, 2016
Kind
B2
Abstract

Methods and apparatus are provided for treating hypertension, e.g., via a pulsed electric field, via a stimulation electric field, via localized drug delivery, via high frequency ultrasound, via thermal techniques, etc. Such neuromodulation may effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, action potential attenuation or blockade, changes in cytokine up-regulation and other conditions in target neural fibers. In some embodiments, neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such neuromodulation is performed in a bilateral fashion. Bilateral renal neuromodulation may provide enhanced therapeutic effect in some patients as compared to renal neuromodulation performed unilaterally, i.e., as compared to renal neuromodulation performed on neural tissue innervating a single kidney.

Claims (53)

1. A method for treating a human patient with a diagnosed condition or disease associated with cardio-renal function, the method comprising:

positioning a nerve modulation device within renal vasculature of the patient and in the vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and

reducing neural communication to and from the kidney by at least partially ablating the neural fibers of the patient via the nerve modulation device,

wherein the kidney continues to secrete renin in the patient after reducing neural communication with the nerve modulation device,

wherein reducing neural communication to and from the kidney results in improved cardio-renal function of the patient.

2. The method of claim 1 wherein positioning a nerve modulation device within renal vasculature comprises positioning the nerve modulation device within a renal artery of the patient.

3. The method of claim 1 wherein reducing neural communication to and from the kidney by at least partially ablating the neural fibers comprises heating afferent and efferent renal nerves of the patient with RF energy delivered via the nerve modulation device.

4. A method for treating a human patient with diagnosed hypertension, the method comprising:

positioning a nerve modulation device within a renal blood vessel of the patient and in the vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and

directing a neuromodulatory energy from the nerve modulation device to the post-ganglionic neural fibers to reduce neural communication to and from the kidney,

wherein the reduction in neural communication to and from the kidney significantly improves a measureable physiological parameter associated with the hypertension of the patient,

wherein the kidney continues to secrete renin in the patient after the reduction in neural communication with the nerve modulation device.

5. The method of claim 4 wherein positioning a nerve modulation device within a renal blood vessel of the patient comprises positioning the nerve modulation device within a renal artery of the patient.

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

positioning a renal denervation catheter having a treatment device within a renal artery of the patient and in the vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and

directing a neuromodulatory energy from the treatment device to the post-ganglionic neural fibers to reduce neural communication to and from the kidney,

wherein the reduction in neural communication to and from the kidney results in a therapeutically beneficial reduction in blood pressure of the patient.

7. The method of claim 6 wherein the neuromodulatory energy comprises RF energy.

8. A method for catheter-based renal neuromodulation, the method comprising:

positioning a catheter having a therapeutic element within a renal artery of a human patient;

directing a neuromodulatory energy from the therapeutic element to a post-ganglionic neural fiber to attenuate neural traffic to and/or from a kidney of the patient, wherein the attenuation of neural traffic therapeutically treats a diagnosed condition or disease associated with cardio-renal function of the patient; and

removing the catheter from the patient after the attenuation of neural traffic to and/or from the kidney.

9. The method of claim 8 wherein the post-ganglionic neural fiber comprises a renal nerve adjacent the renal artery.

10. The method of claim 9 wherein directing the neuromodulatory energy from the therapeutic element to the post-ganglionic neural fiber comprises partially ablating the renal nerve.

11. The method of claim 9 wherein directing the neuromodulatory energy from the therapeutic element to the post-ganglionic neural fiber comprises ablating the renal nerve.

12. The method of claim 8 wherein the neuromodulatory energy comprises RF energy.

13. The method of claim 8 wherein:

positioning a catheter having a therapeutic element within a renal artery of a human patient comprises positioning the catheter in a patient diagnosed with hypertension; and

wherein directing a neuromodulatory energy from the therapeutic element to a post-ganglionic neural fiber to attenuate the neural traffic to and/or from the kidney results in a therapeutically beneficial reduction in blood pressure of the patient.

14. A method for treating a human patient with a diagnosed condition or disease associated with cardio-renal function, the method comprising:

delivering an energy element to an intravascular location within a renal artery of the patient and adjacent to post-ganglionic neural fibers innervating a kidney of the patient; and

partially ablating the neural fibers of the patient via energy from the energy element,

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

15. A method for treating a human patient with diagnosed hypertension, the method comprising:

positioning a nerve modulation device within a renal blood vessel of the patient and in the vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and

directing one or more neuromodulatory agents or drugs from the nerve modulation device to the post-ganglionic neural fibers to reduce neural communication to and from the kidney,

wherein the reduction in neural communication to and from the kidney significantly improves a measureable physiological parameter associated with the hypertension of the patient,

wherein the kidney continues to secrete renin in the patient after the reduction in neural communication with the nerve modulation device.

16. The method of claim 15 wherein positioning a nerve modulation device within a renal blood vessel of the patient comprises positioning the nerve modulation device within a renal artery of the patient.

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

positioning a renal denervation catheter having a treatment device within a renal artery of the patient and in the vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and

directing one or more neuromodulatory agents or drugs from the treatment device to the post-ganglionic neural fibers to reduce neural communication to and from the kidney,

wherein the reduction in neural communication to and from the kidney results in a therapeutically beneficial reduction in blood pressure of the patient.

18. A method for catheter-based renal neuromodulation, the method comprising:

positioning a catheter having a therapeutic element within a renal artery of a human patient;

directing one or more neuromodulatory agents or drugs from the therapeutic element to a post-ganglionic neural fiber to attenuate neural traffic to and/or from a kidney of the patient, wherein the attenuation of neural traffic therapeutically treats a diagnosed condition or disease associated with cardio-renal function of the patient; and

removing the catheter from the patient after attenuating neural traffic to and/or from the kidney.

19. The method of claim 18 wherein the post-ganglionic neural fiber comprises a renal nerve adjacent the renal artery.

20. The method of claim 19 wherein directing one or more neuromodulatory agents or drugs from the therapeutic element to the post-ganglionic neural fiber comprises partially ablating the renal nerve.

21. The method of claim 19 wherein directing one or more neuromodulatory agents or drugs from the therapeutic element to the post-ganglionic neural fiber comprises ablating the renal nerve.

22. The method of claim 18 wherein:

positioning a catheter having a therapeutic element within a renal artery of a human patient comprises positioning the catheter in a patient diagnosed with hypertension; and

wherein directing one or more neuromodulatory agents or drugs from the therapeutic element to a post-ganglionic neural fiber to attenuate the neural traffic to and/or from the kidney results in a therapeutically beneficial reduction in blood pressure of the patient.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 21, 2016
From: DEMARAIS, DENISE; GIFFORD, HANSON, III; DEEM, MARK; SUTTON, DOUGLAS; LEVIN, HOWARD R.; GELFAND, MARK
To: ARDIAN, INC.
Reel/Frame 038974/0705 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 21, 2016
From: MEDTRONIC ARDIAN LLC
To: MEDTRONIC ARDIAN LUXEMBOURG S.A.R.L.
Reel/Frame 038976/0249 →
CHANGE OF NAME Recorded Jun 21, 2016
From: ARDIAN, INC.
To: MEDTRONIC ARDIAN LLC
Reel/Frame 039111/0924 →
Continuity (21)
Continuation 14549229 · Nov 20, 2014
Continuation 14285217 · May 22, 2014
Continuation 13361620 · Jan 30, 2012
Continuation 11368577 · Mar 6, 2006
Continuation In Part 10408665 · Apr 8, 2003
Continuation In Part 11133925 · May 20, 2005
Continuation 10900199 · Jul 28, 2004
Continuation In Part 10408665
Continuation In Part 11189563 · Jul 25, 2005
Continuation In Part 11129765 · May 13, 2005
Continuation In Part 11266993 · Nov 4, 2005
Continuation In Part 11363867 · Feb 27, 2006
Continuation In Part 11189563
Continuation In Part 11266993
Provisional Application 60442970 · Jan 29, 2003
Provisional Application 60415575 · Oct 3, 2002
Provisional Application 60370190 · Apr 8, 2002
Provisional Application 60616254 · Oct 5, 2004
Provisional Application 60624793 · Nov 2, 2004
Provisional Application 60813589 · Dec 29, 2005
Related Publication 20160192985A1 · Jul 7, 2016