IP Library Granted Patent US 11,097,106
Granted Patent B2
US 11,097,106 · App. 16/265,770 · Granted Aug 24, 2021

Implantable neurostimulator-implemented method for managing tachyarrhythmia through vagus nerve stimulation

Inventors: Imad Libbus (St. Paul, MN); Badri Amurthur (Los Gatos, CA); Bruce H. KenKnight (Maple Grove, MN)
Assignee: LivaNovaUSA, Inc.
A61N1/36114A61B5/0245A61B5/283A61B5/352A61B5/363A61B5/4836A61B5/686A61N1/36053A61N1/36139A61N1/3621
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Quick Facts
Patent No.
US 11,097,106
App. No.
16/265,770
Granted
Aug 24, 2021
Kind
B2
Abstract

An implantable neurostimulator-implemented method for managing tachyarrhythmias through vagus nerve stimulation is provided. 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. Operating modes of the pulse generator are stored. 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. A restorative dose of the electrical therapeutic stimulation is delivered to prevent initiation of or disrupt tachyarrhythmia through periodic electrical pulses delivered at higher intensity than the maintenance dose. The patient's normative physiology is monitored via a physiological sensor, and upon sensing a condition indicative of tachyarrhythmia, is switched to delivering the restorative dose to the vagus nerve.

Claims (45)

1. An implantable neurostimulator for managing tachyarrhythmias through vagus nerve stimulation, comprising:

a pulse generator configured to generate electrical stimulation;

a processor; and

a memory having instructions stored thereon that, when executed by the processor, cause the processor to:

define a maintenance dose of the electrical stimulation;

define a restorative dose of the electrical stimulation comprising electrical pulses delivered at a higher intensity than the maintenance dose;

deliver the maintenance dose to an electrode assembly, via the pulse generator, prior to delivering the restorative dose, prior to sensing a condition of tachyarrhythmia, and independent of cardiac cycle;

monitor a patient's normative physiology to sense the condition of tachyarrhythmia via a physiological sensor;

upon sensing the condition of tachyarrhythmia, switch from delivering the maintenance dose to delivering the restorative dose;

upon sensing a condition indicative of a recurrence of the tachyarrhythmia, determine whether the condition of tachyarrhythmia is at least one of a paroxysmal or a life-threatening tachyarrhythmia;

upon determining that the condition of tachyarrhythmia is the at least one of the paroxysmal or the life-threatening tachyarrhythmia, increase an intensity of the restorative dose to an increased intensity at a first rate; and

upon determining that the condition of tachyarrhythmia is not the at least one of the paroxysmal or the life-threatening tachyarrhythmia, increase the intensity of the restorative dose to the increased intensity at a second rate, the second rate being slower than the first rate.

2. The implantable neurostimulator of claim 1 , wherein the higher intensity of the restorative dose comprises at least one of a higher output current, higher duty cycle, higher frequency, or longer pulse width than the maintenance dose.

3. The implantable neurostimulator of claim 1 , wherein the instructions further cause the processor to:

monitor at least one of a sinus rhythm of the patient or a heart rate of the patient; and

sense the condition indicative of tachyarrhythmia based on at least one of an abnormal sinus rhythm of the patient or the heart rate of the patient rising above a maximum threshold.

4. The implantable neurostimulator of claim 1 , wherein the instructions further cause the processor to, after continuing delivery of the restorative dose and upon sensing another condition indicative of a recurrence of the tachyarrhythmia, terminate delivery of the restorative dose.

5. A method for managing tachyarrhythmia through vagus nerve stimulation, comprising:

defining a maintenance dose of electrical stimulation;

defining a restorative dose of the electrical stimulation comprising electrical pulses delivered at a higher intensity than the maintenance dose;

delivering, using a pulse generator of an implantable medical device, the maintenance dose, prior to delivering the restorative dose, prior to sensing a condition of tachyarrhythmia, and independent of cardiac cycle;

monitoring, using a sensor of the implantable medical device, a patient's normative physiology to sense the condition of tachyarrhythmia;

upon sensing the condition of tachyarrhythmia, switching from delivering the maintenance dose to delivering the restorative dose;

upon sensing a condition indicative of a recurrence of the tachyarrhythmia, determining whether the condition of tachyarrhythmia is at least one of a paroxysmal or a life-threatening tachyarrhythmia;

upon determining that the condition of tachyarrhythmia is the at least one of the paroxysmal or the life-threatening tachyarrhythmia, increasing an intensity of the restorative dose to an increased intensity at a first rate; and

upon determining that the condition of tachyarrhythmia is not the at least one of the paroxysmal or the life-threatening tachyarrhythmia, increasing the intensity of the restorative dose to the increased intensity at a second rate, the second rate being slower than the first rate.

6. The method of claim 5 , wherein the higher intensity of the restorative dose comprises at least one of a higher output current, higher duty cycle, higher frequency, or longer pulse width than the maintenance dose.

7. The method of claim 5 , wherein monitoring, using the sensor, the patient's normative physiology to sense the condition of tachyarrhythmia comprises:

monitoring, using the sensor, at least one of a sinus rhythm of the patient or a heart rate of the patient; and

sensing the condition of tachyarrhythmia based on at least one or an abnormal sinus rhythm of the patient or the heart rate of the patient rising above a maximum threshold.

8. The method of claim 5 , further comprising, after continuing delivery of the restorative dose and upon sensing another condition indicative of a recurrence of the tachyarrhythmia, terminating delivery of the restorative dose.

9. A non-transitory computer-readable medium comprising instructions executable by a processor of an implantable medical device to perform operations comprising:

defining a maintenance dose of electrical stimulation;

defining a restorative dose of the electrical stimulation comprising electrical pulses delivered at a higher intensity than the maintenance dose;

delivering, using a pulse generator of the implantable medical device, the maintenance dose, prior to delivering the restorative dose, prior to sensing a condition of tachyarrhythmia, and independent of cardiac cycle;

monitoring, using a sensor of the implantable medical device, a patient's normative physiology to sense the condition of tachyarrhythmia;

upon sensing the condition of tachyarrhythmia, switching from delivering the maintenance dose to delivering the restorative dose; and

upon sensing a condition indicative of a recurrence of the tachyarrhythmia, determining whether the condition of tachyarrhythmia is at least one of a paroxysmal or a life-threatening tachyarrhythmia;

upon determining that the condition of tachyarrhythmia is the at least one of the paroxysmal or the life-threatening tachyarrhythmia, increasing an intensity of the restorative dose to an increased intensity at a first rate; and

upon determining that the condition of tachyarrhythmia is not the at least one of the paroxysmal or the life-threatening tachyarrhythmia, increasing the intensity of the restorative dose to the increased intensity at a second rate, the second rate being slower than the first rate.

10. The non-transitory computer-readable medium of claim 9 , the higher intensity of the restorative dose comprises at least one of a higher output current, a higher duty cycle, higher frequency, or longer pulse width than the maintenance dose.

11. The non-transitory computer-readable medium of claim 9 , wherein monitoring, using the sensor, the patient's normative physiology to sense the condition of tachyarrhythmia comprises:

monitoring, using the sensor, at least one of a sinus rhythm of the patient or a heart rate of the patient; and

sensing the condition of tachyarrhythmia based on at least one of an abnormal sinus rhythm of the patient or the heart rate of the patient rising above a maximum threshold.

12. The non-transitory computer-readable medium of claim 9 , wherein the operations further comprise, after continuing delivery of the restorative dose and upon sensing another condition indicative of a recurrence of the tachyarrhythmia, terminating delivery of the restorative dose.

Assignments (5)
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 →
PATENT SECURITY AGREEMENT Recorded Jun 17, 2020
From: LIVANOVA USA, INC.
To: ARES CAPITAL CORPORATION, AS COLLATERAL AGENT
Reel/Frame 053673/0675 →
Continuity (4)
Continuation 15706946 · Sep 18, 2017
Continuation 15274919 · Sep 23, 2016
Continuation 13673766 · Nov 9, 2012
Related Publication 20190167999A1 · Jun 6, 2019