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

• US 9,452,290 B2
• Filed: 11/09/2012
• Issued: 09/27/2016
• 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:
  US13/673,766
• Publication Number:
  US 20140135862A1
• Time in Patent Office: 1,418 Days
• Field of Search: 607/9, 607/14, 607 17- 19
• US Class Current: 1/1
• 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-implemented method for managing tachyarrhythmias through vagus nerve stimulation, comprising the steps of:

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 of the cervical vagus nerve of a patient;

storing an operating mode of the pulse generator in a recordable memory, the storing comprising;

parametrically defining a maintenance dose of the electrical therapeutic stimulation tuned to restore cardiac autonomic balance, including determining a duty cycle for the maintenance dose using a function of targeted therapeutic efficacy and potential side effects wherein the duty cycle ranges from about four percent to about thirty-six percent, wherein the maintenance dose comprises continuously-cycling, intermittent and periodic electrical pulses; and

parametrically defining a restorative dose of the electrical therapeutic stimulation tuned to prevent initiation of or disrupt tachyarrhythmia, wherein the restorative dose comprises periodic electrical pulses delivered at higher intensity than the maintenance dose;

therapeutically delivering the maintenance dose at the duty cycle to the vagus nerve prior to delivering the restorative dose, prior to sensing a condition of tachyarrhythmia, and independent of cardiac cycle, via the pulse generator of the implantable neurostimulator through helical electrodes electrically coupled to the pulse generator via a nerve stimulation therapy lead;

monitoring a patient'"'"'s normative physiology to sense the condition of tachyarrhythmia via a physiological sensor of the implantable neurostimulator, and upon sensing the condition of tachyarrhythmia, switching from delivering the maintenance dose to delivering the restorative dose at a higher duty cycle to the vagus nerve via the pulse generator through the pair of helical electrodes; and

controlling the pulse generator to suspend delivery of either the restorative dose or the maintenance dose in response to a signal remotely applied to the implantable neurostimulator.

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

further defining the higher intensity of the restorative dose as comprising one or more of higher output current, higher frequency, and longer pulse width.

3. A method according to claim 1, further comprising the steps of:

recording the patient'"'"'s normative physiology in the recordable memory of the implantable neurostimulator;

determining a statistical average of the patient'"'"'s recorded normative physiology via a controller of the implantable neurostimulator; and

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

4. A method according to claim 3, further comprising the steps of:

assigning more statistical weight to the patient'"'"'s normative physiology which has been recorded recently;

assigning less statistical weight to the patient'"'"'s normative physiology which has been recorded in the past; and

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

5. A method according to claim 1, further comprising the steps of:

during the 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.

6. A method according to claim 5, further comprising the steps of one of:

intensifying the electrical therapeutic stimulation as specified in the operating mode;

moderating the electrical therapeutic stimulation as specified in the operating mode; and

suspending the electrical therapeutic stimulation as specified in the operating mode.

7. A method according to claim 1, further comprising the steps of:

constructing an endocardial electrogram based on the patient'"'"'s normative physiology as sensed through the physiological sensor;

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

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

8. A method according to claim 1, further comprising the step of:

progressively increasing intensity of the electrical stimulation to the vagus nerve when delivering the restorative dose.

9. A method according to claim 1, further comprising the step of:

progressively decreasing intensity of the electrical stimulation to the vagus nerve when resuming the therapeutic delivery of the maintenance dose.

10. A method according to claim 1, further comprising the steps of:

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

monitoring the patient'"'"'s sinus rhythm through at least one of the helical electrodes and the pulse generator; and

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

11. A method according to claim 10, further comprising the steps of:

specifying one or more physiological markers of normal sinus rhythm as a condition indicative of the absence of tachyarrhythmia; and

monitoring the patient'"'"'s sinus rhythm through at least one of the helical electrodes and the pulse generator during the delivery of the restorative dose for at least one physiological marker of normal sinus rhythm.

12. A method according to claim 1, further comprising the steps of:

providing a leadless heart rate sensor configured as part of the pulse generator to sense the patient'"'"'s heart rate in response to the electrical therapeutic stimulation;

specifying a threshold heart rate as indicative of tachyarrhythmia;

monitoring the patient'"'"'s heart rate through the leadless heart rate sensor; and

upon sensing of the patient'"'"'s heart rate rising above the threshold heart rate, triggering the delivery of the restorative dose.

13. A method according to claim 12, further comprising the step of:

monitoring the patient'"'"'s heart rate through the leadless heart rate sensor during the delivery of the restorative dose for the patient'"'"'s heart rate falling below the threshold heart rate.

14. A method according to claim 1, further comprising the step of:

titrating the electrical therapeutic stimulation when beginning or resuming the delivery of either the maintenance dose or the restorative dose.

15. A method according to claim 1,

wherein controlling the pulse generator in response to the signal remotely applied to the implantable neurostimulator, further comprises at least one of:

triggering delivery of either the restorative dose or the maintenance dose.

16. The method according to claim 1,

wherein the maintenance dose has an intensity insufficient to elicit side effects.

17. The method according to claim 1,

wherein the duty cycle for the maintenance dose is further based on a quantitative expression of values of the targeted therapeutic efficacy and an extent of potential side effects.

18. The method according to claim 1,

wherein the duty cycle for the maintenance dose is selected from an optimal duty range represented by a function of an intersection of quantitatively expressed values of a targeted therapeutic efficacy and an extent of potential side effects.

19. A non-transitory computer readable storage medium storing code for executing on an implantable neurostimulator to perform the method according to claim 1.