Methods for bilateral renal neuromodulation

• US 9,265,558 B2
• Filed: 04/23/2014
• Issued: 02/23/2016
• Est. Priority Date: 04/08/2002
• Status: Expired due to Fees

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Zarins, Denise, Gifford, Hanson III, Deem, Mark, Sutton, Douglas, Levin, Howard R., Gelfand, Mark
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US14/260,060
• Publication Number:
  US 20140288531A1
• Time in Patent Office: 671 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation
• CPC Class Codes: A61M 2210/1082 Kidney
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/0412 Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

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

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.