IP Library Granted Patent US 9,308,043
Granted Patent B2
US 9,308,043 · App. 14/548,810 · Granted Apr 12, 2016

Methods for monopolar renal neuromodulation

Inventors: Denise Zarins (Los Gatos, CA); Hanson Gifford, III (Woodside, CA); Mark Deem (Mountain View, CA); Howard R. Levin (Teaneck, NJ); Mark Gelfand (New York, NY); Nicolas Zadno (Fremont, CA)
Assignee: Medtronic Ardian Luxembourg S.a.r.l.
A61B18/1492A61B5/4848A61B5/0536A61B5/201A61B2018/0022A61B2018/00267A61B2018/00434A61B2018/00577A61B2018/00613A61B2018/00642A61N1/3606
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Quick Facts
Patent No.
US 9,308,043
App. No.
14/548,810
Granted
Apr 12, 2016
Kind
B2
Abstract

Methods and apparatus are provided for monopolar neuromodulation, e.g., via a pulsed electric field. Such monopolar 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, monopolar neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such monopolar neuromodulation is performed bilaterally.

Claims (35)

1. A method for treating diagnosed hypertension by renal neuromodulation of a human patient, the method comprising:

placing a monopolar electrode within renal vasculature and in contact with a vessel wall of the renal vasculature of the patient, wherein the monopolar electrode is proximate to a post-ganglionic nerve innervating a kidney of the patient;

electrically coupling a ground electrode to an exterior of the patient; and

delivering an electric field between the monopolar electrode and the ground electrode to reduce neural communication along the post-ganglionic nerve,

wherein delivering the electric field results in a therapeutically beneficial reduction in blood pressure of the patient.

2. The method of claim 1 wherein reducing neural communication along the post-ganglionic nerve comprises ablating the nerve.

3. The method of claim 1 wherein reducing neural communication along the post-ganglionic nerve comprises partially ablating the nerve.

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

placing a monopolar electrode within a renal artery of the patient, wherein the monopolar electrode is adjacent to a post-ganglionic nerve innervating a kidney of the patient;

coupling a ground electrode to an exterior of the patient; and

delivering an electric field between the monopolar electrode and the ground electrode, wherein the electric field reduces neural communication along the post-ganglionic nerve,

wherein delivering the electric field results in a therapeutically beneficial reduction in blood pressure of the patient.

5. The method of claim 4 wherein placing a monopolar electrode within a renal artery of the patient comprising intravascularly delivering the electrode to the renal artery via a femoral artery and an aorta of the patient.

6. The method of claim 4 wherein reducing neural communication along the post-ganglionic nerve comprises blocking neural traffic to and/or from the kidney.

7. The method of claim 4 wherein reducing neural communication along the post-ganglionic nerve comprises attenuating afferent neural traffic to and/or from the kidney.

8. The method of claim 4 wherein reducing neural communication along the post-ganglionic nerve comprises attenuating efferent neural traffic to and/or from the kidney.

9. The method of claim 4 wherein the monopolar electrode is carried by an expandable basket, and wherein placing a monopolar electrode within a renal artery of the patient comprises delivering the expandable basket to the renal artery in a low-profile configuration and transforming the basket to a deployed configuration to place the electrode in contact with a wall of the renal artery.

10. The method of claim 4 , further comprising monitoring a parameter of tissue within the patient before and during delivery of the electric field.

11. The method of claim 10 , further comprising modifying delivery of the electric field in response to the monitored parameter.

12. The method of claim 4 wherein reducing neural communication along the post-ganglionic nerve comprises ablating the post-ganglionic nerve.

13. The method of claim 4 wherein reducing neural communication along the post-ganglionic nerve comprises partially ablating the post-ganglionic nerve.

14. The method of claim 4 wherein placing a monopolar electrode within a renal artery of the patient comprises:

positioning an expandable member carrying two or more electrodes within the renal artery in a low-profile delivery arrangement; and

transforming the expandable member into a treatment arrangement to place the two or more electrodes in apposition with a wall of the renal artery before delivering the electric field.

15. The method of claim 14 wherein the expandable member comprises a balloon.

16. The method of claim 4 wherein placing a monopolar electrode within a renal artery of the patient comprises placing the electrode in contact with a vessel wall of the renal artery adjacent to the post-ganglionic nerve.

17. The method of claim 4 , further comprising removing the monopolar electrode from the patient after delivering the electric field.

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

intravascularly positioning a catheter having a monopolar electrode within a renal artery of a human patient and in vicinity of renal nerves innervating a kidney of the patient; and

reducing neural communication to and from the kidney by ablating the renal nerves of the patient via electrical energy delivered between the monopolar electrode and a ground pad on the skin of the patient,

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

19. The method of claim 18 wherein intravascularly positioning a catheter having a monopolar electrode within a renal artery of the patient comprises intravascularly delivering the catheter to the renal artery via a guidewire.

20. The method of claim 18 wherein the catheter comprises a basket with a plurality of struts and monopolar electrodes on each strut, and wherein intravascularly positioning a catheter having a monopolar electrode within a renal artery comprises intravascularly delivering the basket to the renal artery in a delivery arrangement and transforming the basket to a deployed configuration to place the monopolar electrodes carried by the struts in apposition with an inner wall of the renal artery.

21. The method of claim 18 wherein reducing neural communication to and from the kidney by ablating the renal nerves of the patient comprises thermally altering the renal nerves via the electrical energy.

22. The method of claim 18 , further comprising removing the catheter from the patient after ablating the renal nerves.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 20, 2014
From: DEMARAIS, DENISE; GIFFORD, HANSON, III; DEEM, MARK; LEVIN, HOWARD R.; GELFAND, MARK; ZADNO, NICOLAS
To: ARDIAN, INC.
Reel/Frame 034224/0583 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 20, 2014
From: MEDTRONIC ARDIAN LLC
To: MEDTRONIC ARDIAN LUXEMBOURG S.A.R.L.
Reel/Frame 034224/0613 →
CHANGE OF NAME Recorded Nov 20, 2014
From: ARDIAN, INC.
To: MEDTRONIC ARDIAN LLC
Reel/Frame 034410/0755 →
Continuity (15)
Continuation 13958450 · Aug 2, 2013
Continuation 13371285 · Feb 10, 2012
Division 11403329 · Apr 13, 2006
Continuation In Part 11129765 · May 13, 2005
Continuation In Part 10408665 · Apr 8, 2003
Continuation In Part 11189563 · Jul 25, 2005
Continuation In Part 11266993 · Nov 4, 2005
Continuation In Part 11363867 · Feb 27, 2006
Provisional Application 60442970 · Jan 29, 2003
Provisional Application 60415575 · Oct 3, 2002
Provisional Application 60370190 · Apr 8, 2002
Provisional Application 60813589 · Dec 29, 2005
Provisional Application 60616254 · Oct 5, 2004
Provisional Application 60624793 · Nov 2, 2004
Related Publication 20150080884A1 · Mar 19, 2015