Methods for bilateral renal neuromodulation

• US 9,131,978 B2
• Filed: 04/23/2014
• Issued: 09/15/2015
• Est. Priority Date: 04/08/2002
• Status: Expired due to Term

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Zarins, Denise, Gifford, Hanson, Deem, Mark, Sutton, Douglas, Levin, Howard R., Gelfand, Mark
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US14/259,992
• Publication Number:
  US 20140288545A1
• Time in Patent Office: 510 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 reversible electroporation A61N1/327
• 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 with a diagnosed condition comprising at least one of heart failure, hypertension, acute myocardial infarction, impaired renal function, or chronic renal failure, the method comprising:

intravascularly positioning a first catheter comprising a single first electrode within a first renal blood vessel of a human patient and proximate to neural fibers that innervate a first kidney of the patient; and

inhibiting neural communication along the neural fibers innervating the first kidney via radio frequency (RF) energy from the first electrode;

intravascularly positioning a second catheter comprising a single second electrode within a second renal blood vessel of the patient and proximate to neural fibers that innervate a second kidney of the patient; and

inhibiting neural communication along the neural fibers innervating the second kidney via RF energy from the second electrode, wherein inhibiting neural communication along the neural fibers innervating the first and second kidney significantly improves a measurable physiological parameter corresponding to the diagnosed condition of the patient.

2. 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.

3. 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.

4. The method of claim 1 wherein the first electrode and the second electrode comprise tip electrodes.

5. The method of claim 1 wherein:

the first electrode is configured to contact, but not pass through, a wall of the first renal blood vessel; and

the second electrode is configured to contact, but not pass through, a wall of the second renal blood vessel.

6. The method of claim 1 wherein:

intravascularly positioning a first catheter comprises intravascularly delivering the first catheter through an aorta to a first renal artery of the patient via a first guide catheter; and

intravascularly positioning a second catheter comprises intravascularly delivering the second catheter through the aorta to a second renal artery of the patient via a second guide catheter.

7. The method of claim 1 wherein the first electrode and the second electrode comprise monopolar electrodes, and wherein:

inhibiting neural communication along the neural fibers innervating the first kidney via RF energy comprises delivering RF energy in a monopolar fashion between the first electrode and an external ground pad on the patient such that the resulting energy field attenuates neural communication along the neural fibers innervating the first kidney; and

inhibiting neural communication along the neural fibers innervating the second kidney via RF energy comprises delivering RF energy in a monopolar fashion between the second electrode and the external ground pad such that the resulting energy field attenuates neural communication along the neural fibers innervating the second kidney.

8. The method of claim 1 wherein inhibiting neural communication along the neural fibers innervating the first kidney via RF energy from the first electrode comprises delivering RF energy at a first treatment site along the first renal blood vessel, and wherein the method further comprises:

repositioning the first electrode at a second treatment site within the first renal blood vessel after delivering RF energy at the first treatment site; and

after repositioning, energizing the electrode to deliver RF energy to neural fibers at the second treatment site along the first renal blood vessel.

9. The method of claim 1, further comprising:

monitoring a first parameter of the first electrode and/or tissue proximate to the neural fibers that innervate the first kidney during therapy; and

monitoring a second parameter of the second electrode and/or tissue proximate to the neural fibers that innervate the second kidney during therapy.

10. The method of claim 9, further comprising adjusting a treatment parameter in response to the monitoring.

11. The method of claim 9 wherein monitoring a first and a second parameter comprises monitoring impedance and/or temperature.

12. The method of claim 9, further comprising controlling the delivery of RF energy from the first electrode and the delivery of RF energy from the second electrode in response to the monitored first parameter and monitored second parameter, respectively.

13. 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.

14. The method of claim 1 wherein:

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

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

15. 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.

16. The method of claim 1 wherein:

inhibiting neural communication along the neural fibers innervating the first kidney comprises thermally altering the neural fibers in a manner that reduces neural traffic to and from the first kidney; and

inhibiting neural communication along the neural fibers innervating the second kidney comprises thermally altering the neural fibers in a manner that reduces neural traffic to and from the second kidney.

17. The method of claim 1 wherein the first catheter and the second catheter are the same catheter.

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

intravascularly positioning a first renal denervation catheter comprising an elongated flexible shaft and a single tip electrode within a first renal artery of the patient, wherein the tip electrode of the first catheter is configured to physically contact a first target wall region within the first renal artery;

at least partially ablating nerves along the first renal artery via radio frequency (RF) energy from the tip electrode of the first catheter;

intravascularly positioning a second renal denervation catheter comprising an elongated flexible shaft and a single tip electrode within a second renal artery of the patient, wherein the tip electrode of the second catheter is configured to physically contact a second target wall region within the second renal artery; and

at least partially ablating nerves along the second renal artery via RF energy from the tip electrode of the second catheter, 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 18, further comprising removing the first catheter from the first renal artery of the patient before intravascularly positioning the second catheter within the second renal artery of the patient.

20. The method of claim 18 wherein at least partially ablating the nerves along the first renal artery and the nerves along the second renal artery further results in a therapeutically beneficial reduction in central sympathetic overactivity of the patient.

21. The method of claim 18 wherein the first catheter further comprises a sensor proximate to the tip electrode and configured to monitor at least one of temperature and impedance, and wherein the method further comprises controlling ablation of the nerves along the first renal artery based, at least in part, on monitored temperature and/or impedance.

22. The method of claim 18 wherein at least partially ablating the nerves along the first renal artery and the nerves along the second renal artery further results in a therapeutically beneficial reduction in clinical symptoms of heart failure in the patient.

23. (The method of claim 18 wherein the first renal denervation catheter and the second renal denervation catheter are the same catheter.