Methods and apparatus for bilateral renal neuromodulation

• US 9,486,270 B2
• Filed: 08/03/2015
• Issued: 11/08/2016
• 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 III, Deem, Mark, Sutton, Douglas, Levin, Howard R., Gelfand, Mark
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US14/816,115
• Publication Number:
  US 20160030736A1
• Time in Patent Office: 463 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 renal neuromodulation of a human patient, the method comprising:

delivering a first ultrasound to neural fibers disposed adjacent a first renal blood vessel and innervating a first kidney, wherein the first ultrasound inhibits neural traffic along the neural fibers innervating the first kidney; and

delivering a second ultrasound to neural fibers disposed adjacent a second renal blood vessel and innervating a second kidney, wherein the second ultrasound 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 neural fibers innervating the second kidney results in a therapeutically beneficial reduction in central sympathetic overactivity of the patient.

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

3. The method of claim 1 wherein the first ultrasound is a high frequency ultrasound.

4. The method of claim 1 further comprising:

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

wherein the first ultrasound is delivered via the first catheter.

5. The method of claim 4 further comprising:

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

wherein the second ultrasound is delivered via the second catheter.

6. The method of claim 5, 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.

7. The method of claim 5 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.

8. The method of claim 5 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.

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:

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.

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

intravascularly positioning a catheter 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 ultrasound from the catheter;

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 ultrasound from the 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 central sympathetic overactivity of the patient.

13. The method of claim 12, further comprising removing the catheter from the patient after delivering the first and second ultrasounds to conclude the procedure.

14. The method of claim 12 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.

15. The method of claim 12 wherein the first and second ultrasounds are both high frequency ultrasounds.

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

intravascularly positioning a catheter 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 ultrasound from the catheter;

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 ultrasound from the 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 of the patient.

17. The method of claim 16, further comprising removing the catheter from the patient after at least partially ablating nerves along the first and second renal arteries via the first and second ultrasounds, 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 central sympathetic overactivity of the patient.

19. The method of claim 16 wherein the first and second ultrasounds are both high frequency ultrasounds.