Implantable neurostimulator-implemented method for managing hypertension through renal denervation and vagus nerve stimulation

• US 9,511,228 B2
• Filed: 01/14/2014
• Issued: 12/06/2016
• Est. Priority Date: 01/14/2014
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Amurthur, Badri, Libbus, Imad, KenKnight, Bruce H.
• Primary Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US14/154,962
• Publication Number:
  US 20150196762A1
• Time in Patent Office: 1,057 Days
• US Class Current: 1/1
• 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 2018/00434 Neural system
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

A method for managing hypertension through renal nerve denervation and vagus nerve stimulation is provided. Renal nerves are disrupted to inhibit a sympathetic nervous system. Thereafter, an implantable neurostimulator, including a pulse generator, is configured to deliver electrical therapeutic stimulation in a manner that results in creation and propagation (in both afferent and efferent directions) of action potentials within neuronal fibers of a patient'"'"'s cervical vagus nerve. A maintenance dose of the electrical therapeutic stimulation is delivered to the vagus nerve via the pulse generator to restore cardiac autonomic balance through continuously-cycling, intermittent and periodic electrical pulses.

Claims

1. A method for managing hypertension of a patient through vagus nerve stimulation and renal denervation, comprising:

at least partially denervating renal arteries; and

delivering stimulation to a vagus nerve, wherein delivering stimulation to the vagus nerve comprises;

providing an implantable neurostimulator comprising a pulse generator configured to deliver electrical therapeutic stimulation in a manner that results in creation and propagation in both afferent and efferent directions of action potentials within neuronal fibers comprising the cervical vagus nerve;

storing operating modes of the pulse generator in a recordable memory, comprising parametrically defining a maintenance dose of the electrical therapeutic stimulation tuned to restore cardiac autonomic balance through continuously-cycling, intermittent and periodic electrical pulses; and

therapeutically delivering the maintenance dose to the vagus nerve independent of cardiac cycle via the pulse generator comprised in the implantable neurostimulator through at least a pair of electrodes electrically coupled to the pulse generator via a nerve stimulation therapy lead.

2. A method according to claim 1, further comprising:

titrating the stimulation after completing at least partially denervating renal arteries.

3. A method according to claim 2, wherein the titrating the stimulation comprises up titrating and down titrating until a maintenance dose is reached.

4. A method according to claim 2, wherein the delivering stimulation to the vagus nerve comprises:

delivering titration doses to the vagus nerve in response to the at least partially denervating the renal arteries; and

delivering maintenance doses to the vagus nerve after the delivering the titration doses to the vagus nerve.

5. A method according to claim 4, wherein the delivering the titration doses comprises progressively increasing intensity of the titration doses to the vagus nerve.

6. A method according to claim 4, wherein the response to the at least partially denervating the renal arteries comprises an efficacy, and wherein the delivering titration doses to the vagus nerve comprises normalizing the efficacy.

7. A method according to claim 6, wherein the efficacy is determined by a blood pressure measurement.

8. A method according to claim 6, wherein the efficacy is determined by a heart failure remodeling measurement.

9. A method according to claim 6, wherein the normalizing the efficacy comprises up titration and down titration.

10. A method according to claim 1, wherein the at least partially denervating the renal arteries precedes the delivering the stimulation to the vagus nerve.

11. A method according to claim 1, wherein the at least partially denervating renal arteries comprises ablating renal nerves with radiofrequency energy.

12. A method according to claim 11, wherein the ablating renal nerves with the radiofrequency energy comprises positioning at least one electrode in a renal artery.

13. A method according to claim 12, wherein the positioning the at least one electrode in the renal artery comprises positioning a catheter comprising the at least one electrode in the renal artery.

14. A method according to claim 1, wherein the at least partially denervating renal arteries comprises ablating the renal nerves with ultrasound energy.

15. A method according to claim 14, wherein the ablating the renal nerves with the ultrasound energy comprises positioning a transducer external to the patient.

16. A method according to claim 1, wherein the at least partially denervating renal arteries comprises ablating the renal nerves with a chemical.

17. A method according to claim 16, wherein the ablating the renal nerves with the chemical comprises positioning at least one microneedle in a renal artery.

18. A method according to claim 1, wherein the at least partially denervating renal arteries comprises disrupting renal nerves to inhibit a sympathetic nervous system.

19. A method according to claim 1 , further comprising:

prior to the therapeutically delivering the maintenance dose, delivering titration doses to the vagus nerve in response to the disrupting the renal nerves, the titration doses comprising;

up titration doses to gradually approach the maintenance dose; and

down titration doses to reduce adverse side effects.

20. A method according to claim 1, wherein the disrupting the renal nerves comprises:

positioning a catheter within a renal artery, the catheter comprising at least one electrode;

positioning the at least one electrode proximate to at least one of the renal nerves;

energizing the at least one electrode; and

removing the catheter from within the renal artery.