IP Library Granted Patent US 9,511,228
Granted Patent B2
US 9,511,228 · App. 14/154,962 · Granted Dec 6, 2016

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

Inventors: Badri Amurthur (Los Gatos, CA); Imad Libbus (St. Paul, MN); Bruce H. KenKnight (Maple Grove, MN)
Assignee: CYBERONICS, INC.
A61N1/36117A61N1/0551A61N1/36053A61N1/37235A61B18/1492A61B2018/00434
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Quick Facts
Patent No.
US 9,511,228
App. No.
14/154,962
Granted
Dec 6, 2016
Kind
B2
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 (34)

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.

Assignments (7)
RELEASE OF SECURITY INTEREST Recorded Sep 20, 2021
From: ACF FINCO I LP
To: LIVANOVA USA, INC.
Reel/Frame 057552/0378 →
SECURITY INTEREST Recorded Aug 16, 2021
From: LIVANOVA USA, INC.
To: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
Reel/Frame 057188/0001 →
RELEASE OF SECURITY INTEREST Recorded Aug 16, 2021
From: ARES CAPITAL CORPORATION, AS AGENT FOR THE LENDERS
To: LIVANOVA USA, INC.
Reel/Frame 057189/0001 →
PATENT SECURITY AGREEMENT Recorded Dec 30, 2020
From: LIVANOVA USA, INC.
To: ACF FINCO I LP, AS COLLATERAL AGENT
Reel/Frame 054881/0784 →
CHANGE OF NAME Recorded Jun 29, 2020
From: CYBERONICS, INC.
To: LIVANOVA USA, INC.
Reel/Frame 053306/0229 →
PATENT SECURITY AGREEMENT Recorded Jun 17, 2020
From: LIVANOVA USA, INC.
To: ARES CAPITAL CORPORATION, AS COLLATERAL AGENT
Reel/Frame 053673/0675 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2014
From: AMURTHUR, BADRI; LIBBUS, IMAD; KENKNIGHT, BRUCE H.
To: CYBERONICS, INC.
Reel/Frame 032353/0859 →
Continuity (1)
Related Publication 20150196762A1 · Jul 16, 2015