Methods for therapeutic renal denervation

Patent metadata

Field	Value
Publication number	US-9867663-B2
Application number	US-201715458496-A
Country	US
Kind code	B2
Filing date	Mar 14, 2017
Priority date	Apr 8, 2002
Publication date	Jan 16, 2018
Grant date	Jan 16, 2018

Abstract

Methods for therapeutic renal denervation are disclosed herein. One aspect of the present application, for example, is directed to methods that block, reduce and/or inhibit renal sympathetic nerve activity to achieve a reduction in central sympathetic tone. Renal sympathetic nerve activity may be altered or modulated along the afferent and/or efferent pathway. The achieved reduction in central sympathetic tone may carry several therapeutic benefits across many disease states.

First claim

We claim:

1. A method for treating a hypertensive human patient, the method comprising:
intravascularly positioning an energy delivery element within a renal artery of the hypertensive patient;
modulating a renal nerve along the renal artery via energy from the energy delivery element at a plurality of locations along a wall of the renal artery; and
removing the energy delivery element from the patient after treatment,
wherein the patient achieves a decrease in blood pressure of at least 10 mm Hg by six months after modulation of the renal nerve.

2. The method of claim 1 wherein the patient achieves a decrease in blood pressure of at least 20 mm Hg by six months after modulation of the renal nerve.

3. The method of claim 1 wherein the patient achieves a decrease in blood pressure of at least 25 mm Hg by six months after modulation of the renal nerve.

4. The method of claim 1 wherein the patient achieves a decrease in blood pressure of at least 20 mm Hg by twelve months after modulation of the renal nerve.

5. The method of claim 1 wherein the patient achieves a decrease in blood pressure of at least 20 mm Hg by eighteen months after modulation of the renal nerve.

6. The method of claim 1 wherein the patient achieves a decrease in blood pressure of at least 25 mm Hg by eighteen months after modulation of the renal nerve.

7. The method of claim 1 wherein the patient achieves a decrease in blood pressure of at least 20 mm Hg by twenty four months after modulation of the renal nerve.

8. The method of claim 1 wherein the patient achieves a decrease in blood pressure of at least 25 mm Hg by twenty four months after modulation of the renal nerve.

9. The method of claim 1 wherein the patient achieves a decrease in blood pressure of at least 30 mm Hg by twenty four months after modulation of the renal nerve.

10. The method of claim 1 wherein the patient achieves a decrease in blood pressure at twenty four months after modulation of the renal nerve greater than the observed decrease in blood pressure at twelve months after modulation.

11. The method of claim 1 wherein the patient is on a maximum tolerable dosage of one or more antihypertensive drugs before treatment.

12. The method of claim 1 wherein the patient is on a maximum tolerable dosage of at least three antihypertensive drugs before treatment.

13. The method of claim 1 wherein the decrease in blood pressure in the patient after treatment further results in the patient eliminating one or more of the prescribed antihypertensive medications from the regimen while maintaining the blood pressure reduction.

14. The method of claim 1 wherein the reduction in blood pressure in the patient after therapy further results in the patient eliminating two or more of the prescribed antihypertensive medications from the regimen while maintaining the reduction in blood pressure.

15. The method of claim 1 wherein modulating a renal nerve along the renal artery via energy from the energy delivery element comprises partially ablating the renal nerve.

16. The method of claim 1 wherein modulating a renal nerve along the renal artery via energy from the energy delivery element comprises ablating the renal nerve.

17. The method of claim 1 wherein the patient has a baseline blood pressure before treatment of at least about 160 mm Hg.

18. The method of claim 1 wherein:
the energy delivery element has a plurality of electrodes arranged along an elongated member, and further wherein the elongated member is transformable between (a) a low-profile delivery configuration for intravascularly passage to a target site within the renal artery and (b) a deployed configuration in which the elongated member assumes a generally spiral shape and is configured to contact the wall of the renal artery;
intravascularly positioning an energy delivery element within a renal artery of the patient comprises transforming the elongated member from the delivery configuration into the deployed configuration such that the elongated member assumes the generally spiral shape and the plurality of electrodes carried thereon are positioned in contact with treatment locations arranged in a spiral pattern along the wall of the renal artery; and
modulating a renal nerve along the renal artery comprises delivering electrical energy via the plurality of electrodes and ablating the renal nerve.

19. The method of claim 1 wherein the energy delivery element comprises a balloon and a plurality of bipolar electrodes carried by the balloon, and wherein:
intravascularly positioning an energy delivery element within a renal artery of the patient comprises positioning the balloon at a distal portion of the renal artery and transforming the balloon from a low-profile delivery configuration into a deployed configuration such that the bipolar electrodes carried by the balloon are positioned in contact with treatment locations along the wall of the renal artery; and
modulating a renal nerve along the renal artery comprises delivering electrical energy via the bipolar electrodes and ablating the renal nerve.

20. The method of claim 1 wherein the patient is further diagnosed with sleep apnea and having an apnea hypopnea index (AHI) of greater than 5 events/hour, and wherein:
modulating a renal nerve along the renal artery via energy from the energy delivery element further comprises reducing central sympathetic drive in the patient in a manner that lowers the AHI of the patient by at least 5 events/hour at 6 months after treatment, thereby treating the patient for the sleep apnea.

21. The method of claim 1 wherein the patient is further diagnosed with a condition comprising at least one of insulin resistance, diabetes, and metabolic syndrome, and wherein:
modulating a renal nerve along the renal artery via energy from the energy delivery element further comprises reducing central sympathetic drive in the patient in a manner that treats the patient for the diagnosed condition by reducing the patient's hemoglobin A1c (HgA1c).

Assignees

• Medtronic Ardian Luxembourg

Inventors

• Barman Neil
• Levin Howard
• Sobotka Paul
• Gelfand Mark

Classifications

• A61K31/165

  having aromatic rings, e.g. colchicine, atenolol, progabide · CPC title

• A61K31/506

  not condensed and containing further heterocyclic rings · CPC title

• A61N1/326

  for promoting growth of cells, e.g. bone cells · CPC title

• A61B18/1492 Primary

  having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence) · CPC title

• A61B2018/00702

  Power or energy · CPC title