Methods and apparatus for bilateral renal neuromodulation

• US 9,814,873 B2
• Filed: 09/19/2016
• Issued: 11/14/2017
• 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, III, Hanson, Deem, Mark, Sutton, Douglas, Levin, Howard R., Gelfand, Mark
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US15/269,010
• Publication Number:
  US 20170080214A1
• Time in Patent Office: 421 Days
• 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 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.