IP Library Granted Patent US 9,308,044
Granted Patent B2
US 9,308,044 · App. 14/549,229 · Granted Apr 12, 2016

Methods for therapeutic renal neuromodulation

Inventors: Denise Zarins (Los Gatos, 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.
A61B18/1492A61B2018/0022A61B2018/00267A61B2018/00404A61B2018/00434A61B2018/00511
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Quick Facts
Patent No.
US 9,308,044
App. No.
14/549,229
Granted
Apr 12, 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 (34)

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

positioning an energy element within a renal artery of the patient and proximate post-ganglionic neural fibers innervating a kidney of the patient; and

at least partially ablating the neural fibers of the patient via the energy element,

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

2. A method for therapeutic renal denervation of a human patient having a diagnosed condition or disease associated with central sympathetic overactivity, the method comprising:

positioning a thermal element within a renal artery of the patient and adjacent to post-ganglionic neural fibers innervating a kidney of the patient; and

at least partially ablating the neural fibers of the patient via the thermal element,

wherein at least partially ablating the neural fibers results in a therapeutically beneficial reduction in central sympathetic overactivity of the patient.

3. The method of claim 2 wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of hypertension in the patient.

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

intravascularly positioning a nerve modulation device within a renal artery of the patient and in 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 energy from the nerve modulation device,

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

5. The method of claim 4 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 radiofrequency (RF) energy delivered via the nerve modulation device.

6. The method of claim 5 wherein heating afferent and efferent renal nerves of the patient with RF energy comprises delivering RF energy to the renal nerves in a monopolar fashion.

7. The method of claim 5 wherein heating afferent and efferent renal nerves of the patient with RF energy comprises delivering RF energy to the renal nerves in a bipolar fashion.

8. The method of claim 4 wherein reducing neural communication to and from the kidney by at least partially ablating the neural fibers comprises irreversibly ablating the neural fibers.

9. The method of claim 4 wherein reducing neural communication to and from the kidney by at least partially ablating the neural fibers comprises reducing afferent neural traffic from the kidney.

10. A method for therapeutic renal denervation of a human patient having a diagnosed condition or disease associated with central sympathetic overactivity, the method comprising:

positioning a thermal element within a renal artery of the patient and adjacent to post-ganglionic neural fibers innervating a kidney of the patient; and

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

wherein at least partially ablating the neural fibers results in a therapeutically beneficial reduction in central sympathetic overactivity of the patient.

11. The method of claim 10 wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of hypertension in the patient.

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

intravascularly positioning a catheter having an electrode within a renal artery of a human patient;

ablating nerves that innervate a kidney of the patient via radio frequency (RF) energy from the electrode,

wherein ablating the nerves results in a therapeutically beneficial reduction in central sympathetic overactivity in the patient; and

removing the catheter from the patient after ablating the nerves.

13. The method of claim 12 wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of hypertension in the patient.

14. The method of claim 12 wherein intravascularly positioning a catheter having an electrode within a renal artery comprises intravascularly positioning an expandable basket carrying a plurality of electrodes within the renal artery of the patient.

15. The method of claim 12 wherein intravascularly positioning a catheter having an electrode within a renal artery comprises intravascularly positioning an expandable balloon carrying a plurality of electrodes within the renal artery of the patient.

16. The method of claim 12 wherein intravascularly positioning a catheter having an electrode within a renal artery comprising positioning the catheter and electrode at a first location within the renal artery, and ablating nerves that innervate the kidney comprises a first ablation procedure, and wherein the method further comprises:

positioning the catheter and electrode at a second, different location within the renal artery after the first ablation procedure; and

ablating nerves that innervate the kidney via RF energy from the electrode in a second ablation procedure.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 20, 2014
From: DEMARAIS, DENISE; GIFFORD, HANSON, III; DEEM, MARK; SUTTON, DOUGLAS; LEVIN, HOWARD R.; GELFAND, MARK
To: ARDIAN, INC.
Reel/Frame 034224/0400 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 20, 2014
From: MEDTRONIC ARDIAN LLC
To: MEDTRONIC ARDIAN LUXEMBOURG S.A.R.L.
Reel/Frame 034224/0529 →
CHANGE OF NAME Recorded Nov 20, 2014
From: ARDIAN, INC.
To: MEDTRONIC ARDIAN LLC
Reel/Frame 034410/0749 →
Continuity (20)
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 · Apr 8, 2003
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 · Jul 25, 2005
Continuation In Part 11266993 · Nov 4, 2005
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
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