Implantable neurostimulator-implemented method for managing tachyarrhythmic risk during sleep through vagus nerve stimulation

• US 9,643,011 B2
• Filed: 03/14/2013
• Issued: 05/09/2017
• Est. Priority Date: 03/14/2013
• 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): Hankins, Lindsey G
• Application Number:
  US13/828,486
• Publication Number:
  US 20140277232A1
• Time in Patent Office: 1,517 Days
• Field of Search: 607 2, 607 14
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/4809 Sleep detection, i.e. determining whether a subject is asleep or not
• 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

A patient suffering from congestive heart failure is at increased risk of cardiac arrhythmogenesis during sleep, particularly if experiencing central sleep apnea as a co-morbidity. Low intensity peripheral neurostimulation therapies that target imbalance of the autonomic nervous system have been shown to improve clinical outcomes. Thus, bi-directional autonomic regulation therapy is delivered to the cervical vagus nerve at an intensity that is insufficient to elicit pathological or acute physiological side effects and without the requirement of an enabling physiological feature or triggering physiological marker. The patient'"'"'s physiology is monitored to identify periods of sleep. In one embodiment, upon sensing a condition indicative of tachyarrhythmia following a period of bradycardia, as naturally occurs during sleep, an enhanced “boost” dose of bi-directional neural stimulation intended to “break” the tachyarrhythmic condition is delivered. In a further embodiment, the boost dose is delivered upon sensing a physiological pattern indicative of Cheyne-Stokes respiration.

Claims

1. An implantable neurostimulator-implemented method for managing tachyarrhythmic risk accompanying central sleep apnea 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 (simultaneously in both afferent and efferent directions) of action potentials within neuronal fibers comprising a patient'"'"'s 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 at an intensity that avoids acute physiological side effects and with an unchanging cycle not triggered by physiological markers; and

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

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

monitoring the patient'"'"'s physiological state via at least one sensor comprised in the implantable neurostimulator, and upon sensing a pattern indicative of Cheyne-Stokes respiration, delivering the boost dose to the vagus nerve via the pulse generator through the pair of helical electrodes.

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

monitoring the patient'"'"'s physiological state while awake via at least one sensor comprised in the implantable neurostimulator; and

upon sensing that the patient is asleep, suspending the delivery of the maintenance dose.

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

upon sensing the pattern indicative of Cheyne-Stokes respiration, initially resuming the delivery of the maintenance dose prior to the delivery of the boost dose.

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

providing a minute ventilation sensor as the at least one sensor;

periodically sensing the patient'"'"'s tidal volume and respiratory rate with the minute ventilation sensor; and

confirming that the pattern is indicative of Cheyne-Stokes respiration when the patient'"'"'s tidal volume and respiratory rate gradually wax, peak and wane in a periodic pattern.

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

progressively intensifying the electrical therapeutic stimulation as specified in the operating mode of the boost dose as the condition indicative of tachyarrhythmia continues.

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

maximizing the intensity of the electrical therapeutic stimulation as specified in the operating mode when the condition indicative of tachyarrhythmia fails to respond to the intensified electrical therapeutic stimulation.

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

8. An implantable neurostimulator-implemented apparatus for managing tachyarrhythmic risk accompanying central sleep apnea through vagus nerve stimulation, comprising the steps of:

means for providing an implantable neurostimulator comprising a pulse generator configured to deliver electrical therapeutic stimulation in a manner that results in creation and propagation (simultaneously in both afferent and efferent directions) of action potentials within neuronal fibers comprising a patient'"'"'s cervical vagus nerve;

means for storing operating modes of the pulse generator in a recordable memory, comprising;

means for parametrically defining a maintenance dose of the electrical therapeutic stimulation tuned to restore cardiac autonomic balance through continuously-cycling, intermittent and periodic electrical pulses at an intensity that avoids acute physiological side effects and with an unchanging cycle not triggered by physiological markers; and

means for parametrically defining a boost dose of the electrical therapeutic stimulation tuned to prevent initiation of or disrupt tachyarrhythmia through periodic electrical pulses delivered at higher intensity than the maintenance dose;

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

means for monitoring the patient'"'"'s physiological state via at least one sensor comprised in the implantable neurostimulator, and upon sensing a pattern indicative of Cheyne-Stokes respiration, delivering the boost dose to the vagus nerve via the pulse generator through the pair of helical electrodes.