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

• US 9,764,138 B2
• Filed: 09/23/2016
• Issued: 09/19/2017
• Est. Priority Date: 11/09/2012
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Libbus, Imad, Amurthur, Badri, KenKnight, Bruce H.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US15/274,919
• Publication Number:
  US 20170100592A1
• Time in Patent Office: 361 Days
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate

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

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

a pulse generator configured to couple to an electrode assembly and to generate electrical stimulation;

a processor configured to receive physiological data from a physiological sensor; and

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

store operating modes of the pulse generator in the memory, by;

defining a maintenance dose of the electrical stimulation having a duty cycle ranging from about four percent to about thirty six percent; and

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

deliver the maintenance dose at the duty cycle via the pulse generator to the electrode assembly, 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 the processor receiving the physiological data; and

upon sensing the condition of tachyarrhythmia, switch from delivering the maintenance dose to delivering the restorative dose at a higher duty cycle than the duty cycle of the maintenance dose to the electrode assembly via the pulse generator.

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

record the patient'"'"'s normative physiology in the memory;

determine a statistical average of the patient'"'"'s normative physiology recorded in the memory; and

define the condition of tachyarrhythmia as triggered when the statistical average exceeds a physiological threshold of arrhythmogenesis.

3. The implantable neurostimulator of claim 2, wherein the instructions further cause the processor to:

assign more statistical weight to a first portion of the patient'"'"'s normative physiology that has been recorded recently;

assign less statistical weight to a second portion of the patient'"'"'s normative physiology that has been recorded less recently; and

determine the statistical average as a weighted average of the patient'"'"'s normative physiology.

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

during monitoring, confirm that the patient'"'"'s normative physiology comprises a normal sinus rhythm; and

upon departure from the normal sinus rhythm, modify the operating mode of the pulse generator based on whether the departure signifies an increase, decrease, or entrainment of cardiac rhythm.

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

construct an endocardial electrogram based on the patient'"'"'s normative physiology;

evaluate cardiac rate dynamics from the endocardial electrogram, including identifying R-waves; and

define the condition of tachyarrhythmia as triggered when the R-waves exhibit significant irregularity over a fixed time period.

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

specify one or more physiological markers of abnormally fast sinus rhythm as indicative of tachyarrhythmia;

monitor the patient'"'"'s sinus rhythm via the physiological sensor; and

upon sensing at least one physiological marker of abnormally fast sinus rhythm, trigger delivery of the restorative dose.

7. The implantable neurostimulator of claim 1, further comprising the physiological sensor, wherein said physiological sensor comprises:

a leadless heart rate sensor coupled to the pulse generator to sense a heart rate of the patient in response to the electrical therapeutic stimulation,

wherein the instructions further cause the processor to;

specify a threshold heart rate as indicative of tachyarrhythmia;

monitor the heart rate of the patient through the leadless heart rate sensor; and

upon sensing the heart rate of the patient is above the threshold heart rate, trigger the delivery of the restorative dose.

8. A non-transitory computer-readable medium comprising instructions executable by a processor of an implantable medical device to perform operations, the implantable medical device further comprising a pulse generator and a physiological sensor, the operations comprising:

storing operating modes of the pulse generator of the implantable medical device in the non-transitory computer-readable medium, by;

defining a maintenance dose of an electrical stimulation having a duty cycle ranging from about four percent to about thirty six percent; and

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

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

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

upon sensing the condition of tachyarrhythmia, switching from delivering the maintenance dose to delivering the restorative dose at a higher duty cycle than the duty cycle of the maintenance dose.

9. The non-transitory computer-readable medium of claim 8, wherein the operations further comprise:

recording the patient'"'"'s normative physiology;

determining a statistical average of the patient'"'"'s normative physiology recorded; and

defining the condition of tachyarrhythmia as triggered when the statistical average exceeds a physiological threshold of arrhythmogenesis.

10. The non-transitory computer-readable medium of claim 9, wherein the operations further comprise:

assigning more statistical weight to a first portion of the patient'"'"'s normative physiology that has been recorded recently;

assigning less statistical weight to a second portion of the patient'"'"'s normative physiology that has been recorded less recently; and

determining the statistical average as a weighted average of the patient'"'"'s normative physiology.

11. The non-transitory computer-readable medium of claim 8, wherein the operations further comprise:

during monitoring, confirming that the patient'"'"'s normative physiology comprises a normal sinus rhythm; and

upon departure from the normal sinus rhythm, modifying the operating mode of the pulse generator based on whether the departure signifies an increase, decrease, or entrainment of cardiac rhythm.

12. The non-transitory computer-readable medium of claim 8, wherein the operations further comprise:

constructing an endocardial electrogram based on the patient'"'"'s normative physiology;

evaluating cardiac rate dynamics from the endocardial electrogram, including identifying R-waves; and

defining the condition of tachyarrhythmia as triggered when the R-waves exhibit significant irregularity over a fixed time period.

13. The non-transitory computer-readable medium of claim 8, wherein the operations further comprise:

specifying one or more physiological markers of abnormally fast sinus rhythm as indicative of tachyarrhythmia;

monitoring the patient'"'"'s sinus rhythm via the physiological sensor; and

upon sensing at least one physiological marker of abnormally fast sinus rhythm, triggering delivery of the restorative dose.

14. The non-transitory computer-readable medium of claim 8, wherein the operations further comprise specifying:

a threshold heart rate as indicative of tachyarrhythmia, monitoring the patient'"'"'s normative physiology to sense the condition of tachyarrhythmia comprises monitoring

the heart rate of the patient, and delivery of the restorative dose is triggered in response to sensing the heart rate of the patient is above the threshold heart rate.

15. A method for managing tachyarrhythmias through vagus nerve stimulation, comprising:

storing operating modes for a pulse generator of an implantable medical device within a memory of the implantable medical device by;

defining a maintenance dose of an electrical stimulation having a duty cycle ranging from about four percent to about thirty six percent; and

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

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

monitoring, using a sensor, a patient'"'"'s normative physiology to sense the condition of tachyarrhythmia; and

upon sensing the condition of tachyarrhythmia, switching from delivering the maintenance dose to delivering the restorative dose at a higher duty cycle than the duty cycle of the maintenance dose.

16. The method of claim 15, further comprising:

recording the patient'"'"'s normative physiology;

determining a statistical average of the patient'"'"'s normative physiology recorded; and

defining the condition of tachyarrhythmia as triggered when the statistical average exceeds a physiological threshold of arrhythmogenesis.

17. The method of claim 16, further comprising:

assigning more statistical weight to a first portion of the patient'"'"'s normative physiology that has been recorded recently;

assign less statistical weight to a second portion of the patient'"'"'s normative physiology that has been recorded less recently; and

determining the statistical average as a weighted average of the patient'"'"'s normative physiology.

18. The method of claim 15, further comprising:

during monitoring, confirming that the patient'"'"'s normative physiology comprises a normal sinus rhythm; and

upon departure from the normal sinus rhythm, modifying the operating mode of the pulse generator based on whether the departure signifies an increase, decrease, or entrainment of cardiac rhythm.

19. The method of claim 15, further comprising:

constructing an endocardial electrogram based on the patient'"'"'s normative physiology;

evaluating cardiac rate dynamics from the endocardial electrogram, including identifying R-waves; and

defining the condition of tachyarrhythmia as triggered when the R-waves exhibit significant irregularity over a fixed time period.

20. The method of claim 15, further comprising:

specifying a threshold heart rate as indicative of tachyarrhythmia, wherein monitoring the patient'"'"'s normative physiology to sense the condition of tachyarrhythmia comprises monitoring

the heart rate of the patient, and wherein delivery of the restorative dose is triggered in response to sensing the heart rate of the patient is above the threshold heart rate.