Methods for therapeutic renal neuromodulation using neuromodulatory agents or drugs

• US 10,130,792 B2
• Filed: 03/30/2016
• Issued: 11/20/2018
• 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
• Primary Examiner(s): Osinski, Bradley J
• Application Number:
  US15/085,918
• Publication Number:
  US 20160279384A1
• Time in Patent Office: 965 Days
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• 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 2018/0022 Balloons
• 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: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61K 38/4893 Botulinum neurotoxin (3.4.24.69)
• CPC Class Codes: A61M 2025/0085 Multiple injection needles protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2210/1082 Kidney
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• 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 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: C12Y 304/24069 : Bontoxilysin (3.4.24.69), i.e. botulinum neurotoxin

Abstract

Methods and apparatus are provided for treatment of heart arrhythmia via renal neuromodulation. Such neuromodulation may effectuate irreversible electroporation or electrofusion, ablation, 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, such neuromodulation is achieved through application of an electric field. In some embodiments, such neuromodulation is achieved through application of neuromodulatory agents, of thermal energy and/or of high intensity focused ultrasound. In some embodiments, such neuromodulation is performed in a bilateral fashion.

Claims

1. A method for treating a human patient diagnosed with hypertension, the method comprising:

introducing a catheter having a plurality of infusion needles to a renal artery of the patient and proximate to target renal nerves;

delivering an ablative drug via the infusion needles to tissue external to the renal artery and in contact with the target renal nerves,

wherein the ablative drug at least partially ablates the target renal nerves; and

removing the catheter from the patient to conclude treatment after delivering the ablative drug.

2. The method of claim 1 wherein delivering the ablative drug and at least partially ablating the target renal nerves results in a therapeutically beneficial reduction in blood pressure of the patient.

3. The method of claim 1 wherein delivering an ablative drug via the infusion needles comprises delivering phenol.

4. The method of claim 1 wherein delivering an ablative drug via the infusion needles comprises delivering alcohol.

5. The method of claim 1 wherein delivering an ablative drug via the infusion needles comprises delivering a neurotoxin.

6. The method of claim 1 wherein delivering an ablative drug via the infusion needles comprises delivering a botulinum toxin.

7. The method of claim 1 wherein introducing a catheter having a plurality of infusion needles to a renal artery of the patient comprises delivering the catheter over a guidewire through an abdominal aorta of the patient and into the renal artery.

8. The method of claim 1 wherein delivering the ablative drug to the target renal nerves at least partially denervates a kidney of the patient.

9. The method of claim 1 wherein delivering the ablative drug and at least partially ablating the target renal nerves alters at least one of urine production, fluid retention, renin secretion, waste excretion, sodium retention, systemic vasoconstriction, renal function, heart function and blood pressure in the patient.

10. The method of claim 9 wherein altering urine production comprises increasing urine output.

11. The method of claim 9 wherein altering renin secretion comprises decreasing plasma renin level secretion.

12. The method of claim 9 wherein altering sodium retention comprises increasing sodium excretion.

13. The method of claim 1 wherein the renal artery is a first renal artery and the target renal nerves are first target renal nerves, and wherein the method further comprises:

introducing the catheter to a second renal artery of the patent and proximate to second target renal nerves after delivering the ablative drug via the infusion needles to tissue external to the first renal artery;

delivering the ablative drug via the infusion needles to tissue external to the second renal artery and in contact with the second target renal nerves,

wherein the ablative drug at least partially ablates the second target renal nerves; and

removing the catheter from the patient to conclude treatment after delivering the ablative drug to tissue external to the second renal artery.

14. A method for treating a human patient diagnosed with a cardio-renal disease or disorder, the method comprising:

delivering an agent to target renal nerves of the patient in an amount sufficient to at least partially ablate and thereby modulate neural function of the targeted renal nerves,

wherein modulating neural function of the targeted renal nerves results in a reduction in one or more symptoms associated with the patient'"'"'s cardio-renal disease or disorder.

15. The method of claim 14 wherein delivering an agent to target renal nerves comprises localized delivery of the agent from a catheter within a renal artery of the patient.

16. The method of claim 14 wherein delivering an agent to target renal nerves of the patient comprises delivering a chemical that attenuates or blocks neural signals along the targeted renal nerves.

17. The method of claim 14 wherein the cardio-renal disease or disorder is hypertension.

18. The method of claim 14 wherein the cardio-renal disease or disorder is congestive heart failure.

19. The method of claim 14 wherein the cardio-renal disease or disorder is end-stage renal disease.