IP Library Granted Patent US 9,814,873
Granted Patent B2
US 9,814,873 · App. 15/269,010 · Granted Nov 14, 2017

Methods and apparatus 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.
A61N1/0551A61B18/12A61B18/14A61B18/1492A61M5/1408A61M5/14276A61N1/0412A61N1/05A61N1/327A61N1/36007A61N1/36017A61B2018/00267A61B2018/00351A61B2018/00404A61B2018/00434A61B2018/00511A61B2018/00577A61B2018/00613A61M2210/1082A61N7/00
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Quick Facts
Patent No.
US 9,814,873
App. No.
15/269,010
Granted
Nov 14, 2017
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 (38)

1. A method for reducing blood pressure in a human patient, the method comprising:

implanting a drug pump assembly in the patient below the patient's skin, wherein the drug pump assembly is operably connected to a first catheter and a second catheter;

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

delivering, via the first catheter, a first neuromodulatory agent from the drug pump assembly to tissue external to the first renal blood vessel and in contact with or adjacent 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 proximate a second renal blood vessel of the patient and adjacent to neural fibers innervating a second kidney of the patient; and

delivering, via the second catheter, a second neuromodulatory agent from the drug pump assembly to tissue external to the second renal blood vessel and in contact with or adjacent to the neural fibers innervating the second kidney, wherein the second neuromodulatory agent inhibits neural traffic along the neural fibers innervating the second kidney,

wherein inhibiting neural traffic along the neural fibers innervating the first kidney and the second kidney results in a therapeutically beneficial reduction in blood pressure of the patient.

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, via the first catheter, a first neuromodulatory agent comprises delivering a neurotoxin.

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

5. The method of claim 2 wherein delivering, via the first catheter, a first neuromodulatory agent comprises delivering phenol.

6. The method of claim 2 wherein delivering, via the first catheter, a first neuromodulatory agent comprises delivering alcohol.

7. The method of claim 1 wherein delivering, via the first catheter, the first neuromodulatory agent and delivering, via the second catheter, the second neuromodulatory agent occurs simultaneously.

8. The method of claim 1 wherein delivering, via the first catheter, the first neuromodulatory agent and delivering, via the second catheter, the second neuromodulatory agent occurs sequentially.

9. 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.

10. 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.

11. The method of claim 1 wherein:

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

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

12. 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.

13. A method for bilateral renal denervation of a hypertensive human patient, the method comprising:

positioning a first catheter proximate a first renal artery of the patient and adjacent to first renal nerves innervating a first kidney of the patient;

positioning a second catheter proximate a second renal artery of the patient and adjacent to second renal nerves innervating a second kidney of the patient;

at least partially ablating the first renal nerves along the first renal artery via a first neuromodulatory drug from an implanted drug reservoir within the patient; and

at least partially ablating the second renal nerves along the second renal artery via a second neuromodulatory drug from the implanted drug reservoir,

wherein at least partially ablating the first and second renal nerves results in a therapeutically beneficial reduction in blood pressure of the patient.

14. The method of claim 13 wherein at least partially ablating the first and second renal nerves further results in a therapeutically beneficial reduction in central sympathetic overactivity of the patient.

15. The method of claim 13 wherein the first neuromodulatory drug is different from the second neuromodulatory drug.

16. The method of claim 13 wherein the first neuromodulatory drug is the same as the second neuromodulatory drug.

17. The method of claim 13 wherein the first and second neuromodulatory drugs comprise a neurotoxin, botulinum toxin, phenol, and/or alcohol.

18. The method of claim 13 wherein at least partially ablating the first renal nerves via the first neuromodulatory drug and at least partially ablating the second renal nerves via the second neuromodulatory drug occurs simultaneously.

19. The method of claim 13 wherein at least partially ablating the first renal nerves via the first neuromodulatory drug and at least partially ablating the second renal nerves via the second neuromodulatory drug occurs sequentially.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 5, 2017
From: ZARINS, DENISE; GIFFORD, HANSON, III; DEEM, MARK; SUTTON, DOUGLAS; LEVIN, HOWARD R.; GELFAND, MARK
To: ARDIAN, INC.
Reel/Frame 042594/0130 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 5, 2017
From: MEDTRONIC ARDIAN LLC
To: MEDTRONIC ARDIAN LUXEMBOURG S.A.R.L.
Reel/Frame 042594/0170 →
CHANGE OF NAME Recorded Jun 5, 2017
From: ARDIAN, INC.
To: MEDTRONIC ARDIAN LLC
Reel/Frame 042687/0772 →
Continuity (23)
Continuation 14816115 · Aug 3, 2015
Continuation 14260060 · Apr 23, 2014
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 · 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
Continuation In Part 11129765 · May 13, 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
Related Publication 20170080214A1 · Mar 23, 2017