IP Library Granted Patent US 9,265,558
Granted Patent B2
US 9,265,558 · App. 14/260,060 · Granted Feb 23, 2016

Methods for bilateral 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.
A61B18/12A61B18/14A61B18/1492A61M5/1408A61N1/0412A61N1/05A61N1/327A61N1/36007A61N1/36017A61B2018/00267A61B2018/00434A61B2018/00577A61M5/14276A61M2210/1082A61N1/0551A61N7/00
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Quick Facts
Patent No.
US 9,265,558
App. No.
14/260,060
Granted
Feb 23, 2016
Kind
B2
Abstract

Methods and apparatus are provided for bilateral renal neuromodulation, 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 (51)

1. A method for catheter-based renal neuromodulation of a human patient, the method comprising:

positioning a first catheter within a first renal blood vessel of the patient and proximate to neural fibers innervating a first kidney of the patient;

delivering a first neuromodulatory agent via the first catheter to the neural fibers innervating the first kidney, wherein the first neuromodulatory agent inhibits neural traffic along the neural fibers innervating the first kidney;

positioning a second catheter within a second renal blood vessel of the patient and proximate to neural fibers innervating a second kidney of the patient; and

delivering a second neuromodulatory agent via the second catheter to the neural fibers innervating the second kidney, wherein the second neuromodulatory agent inhibits neural traffic along the neural fibers innervating the second kidney.

2. The method of claim 1 wherein the first neuromodulatory agent is the same as the second neuromodulatory agent.

3. The method of claim 2 wherein delivering a first neuromodulatory agent comprises delivering a neurotoxin.

4. The method of claim 2 wherein delivering a first neuromodulatory agent comprises delivering botulinum toxin.

5. The method of claim 2 wherein delivering a first neuromodulatory agent comprises delivering phenol.

6. The method of claim 2 wherein delivering a first neuromodulatory agent comprises delivering alcohol.

7. The method of claim 1 , further comprising removing the first catheter from the first renal blood vessel of the patient before positioning the second catheter within the second renal blood vessel of the patient.

8. The method of claim 1 wherein positioning the first catheter within the first renal blood vessel of the patient and positioning the second catheter within the second renal blood vessel of the patient occur simultaneously.

9. The method of claim 1 wherein:

positioning the first catheter within the first renal blood vessel of the patient comprises intravascularly delivering the first catheter to the first renal blood vessel over a first guidewire; and

positioning the second catheter within the second renal blood vessel of the patient comprises intravascularly delivering the second catheter to the second renal blood vessel over a second guidewire.

10. The method of claim 1 wherein:

inhibiting neural communication along the neural fibers innervating the first kidney comprises ablating the neural fibers innervating the first kidney; and

inhibiting neural communication along the neural fibers innervating the second kidney comprises ablating the neural fibers innervating the second kidney.

11. The method of claim 1 wherein:

inhibiting neural communication along the neural fibers innervating the first kidney comprises denervating the first kidney of the patient; and

inhibiting neural communication along the neural fibers innervating the second kidney comprises denervating the second kidney of the patient.

12. The method of claim 1 wherein:

delivering a first neuromodulatory agent via the first catheter comprises delivering a fluid to block neural signaling along the neural fibers innervating the first kidney of the patient; and

delivering a second neuromodulatory agent via the second catheter comprises delivering a fluid to block neural signaling along the neural fibers innervating the second kidney of the patient.

13. The method of claim 1 wherein:

inhibiting neural communication along the neural fibers innervating the first kidney comprises reducing renal sympathetic nerve activity of the first kidney; and

inhibiting neural communication along the neural fibers innervating the second kidney comprises reducing renal sympathetic nerve activity of the second kidney.

14. The method of claim 1 wherein:

the first catheter comprises a first infusion needle at a distal portion of the first catheter, and wherein the method further comprises—

passing the first infusion needle through a wall of the first renal blood vessel to position at least a portion of the first infusion needle at an extravascular location in contact with or adjacent to the neural fibers innervating the first kidney,

wherein delivering a first neuromodulatory agent via the first catheter comprises delivering the first neuromodulatory agent via the first infusion needle and ablating at least a portion of the neural fibers innervating the first kidney; and

the second catheter comprises a second infusion needle at a distal portion of the second catheter, and wherein the method further comprises—

passing the second infusion needle through a wall of the first renal blood vessel to position at least a portion of the second infusion needle at an extravascular location in contact with or adjacent to the neural fibers innervating the second kidney,

wherein delivering a second neuromodulatory agent via the second catheter comprises delivering the second neuromodulatory agent via the second infusion needle and ablating at least a portion of the neural fibers innervating the second kidney.

15. The method of claim 14 wherein the distal portion of the first catheter comprises a first side port, and the distal portion of the second catheter comprises a second side port, and wherein:

positioning a first catheter within a first renal blood vessel of the patient comprises positioning the first catheter with the first infusion needle positioned for delivery via the first side port through at least a portion of the wall of the first renal blood vessel; and

positioning a second catheter within a second renal blood vessel of the patient comprises positioning the second catheter with the second infusion needle positioned for delivery via the second side port through at least a portion of the wall of the second renal blood vessel.

16. A method for catheter-based renal denervation of a human patient, the method comprising:

intravascularly positioning a catheter having a drug delivery element within a first renal artery associated with a first kidney of the patient;

at least partially ablating nerves along the first renal artery via a first neuromodulatory agent from the drug delivery element;

intravascularly positioning the catheter within a second renal artery associated with a second kidney of the patient; and

at least partially ablating nerves along the second renal artery via a second neuromodulatory agent from the drug delivery element.

17. The method of claim 16 , further comprising removing the catheter from the patient after delivering the first and second neuromodulatory agents to conclude the procedure.

18. The method of claim 16 wherein at least partially ablating the nerves along the first renal artery and the nerves along the second renal artery results in a therapeutically beneficial reduction in blood pressure in the patient.

19. The method of claim 16 wherein at least partially ablating the nerves along the first renal artery and the nerves along the second renal artery results in a therapeutically beneficial reduction in central sympathetic overactivity of the patient.

20. The method of claim 16 wherein at least partially ablating the nerves along the first renal artery and the nerves along the second renal artery results in a therapeutically beneficial reduction in blood pressure of the patient.

21. The method of claim 16 wherein the first and/or second neuromodulatory agents comprise a neurotoxin, botulinum toxin, phenol, and/or alcohol.

22. The method of claim 21 wherein the first and/or second neuromodulatory agents comprise alcohol.

23. The method of claim 16 wherein the drug delivery element of the catheter is in fluid communication with an external drug reservoir, and wherein:

at least partially ablating nerves along the first renal artery comprises delivering the first neuromodulatory agent from the external drug reservoir to target tissue adjacent the first renal artery via the first drug delivery element; and

at least partially ablating nerves along the second renal artery comprises delivering the second neuromodulatory agent from the external drug reservoir to target tissue adjacent the second renal artery via the second drug delivery element.

Continuity (21)
Continuation 14034434 · Sep 23, 2013
Continuation 13361685 · Jan 30, 2012
Division 11368836 · 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
Continuation In Part 11129765
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 20140288531A1 · Sep 25, 2014