Methods for bilateral renal neuromodulation

Patent metadata

Field	Value
Publication number	US-9265558-B2
Application number	US-201414260060-A
Country	US
Kind code	B2
Filing date	Apr 23, 2014
Priority date	Apr 8, 2002
Publication date	Feb 23, 2016
Grant date	Feb 23, 2016

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.

First claim

We claim:

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 2

Assignees

• Medtronic Ardian Luxembourg

Inventors

• Zarins Denise
• Gifford Iii Hanson
• Deem Mark
• Sutton Douglas
• Levin Howard R
• Gelfand Mark

Classifications

• A61M5/14276

  specially adapted for implantation · CPC title

• A61N1/0551 Primary

  Spinal or peripheral nerve electrodes · CPC title

• A61B18/14

  Probes or electrodes therefor · CPC title

• A61B18/12 Primary

  by passing a current through the tissue to be heated, e.g. high-frequency current · CPC title

• A61B2018/00577

  Ablation · CPC title