Implantable neurostimulator-implemented method for enhancing heart failure patient awakening through vagus nerve stimulation

• US 8,923,964 B2
• Filed: 11/09/2012
• Issued: 12/30/2014
• 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:
  US13/673,811
• Publication Number:
  US 20140135864A1
• Time in Patent Office: 781 Days
• Field of Search: 607/9, 607/14, 607 17- 19
• US Class Current: 607/19
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• 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 5/4812 Detecting sleep stages or cycles
• 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 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• 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 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate

Abstract

An implantable neurostimulator-implemented method for managing tachyarrhythmias upon a patient'"'"'s awakening from sleep 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 comprising the cervical vagus nerve of a patient. Operating modes of the pulse generator are stored. An enhanced dose of the electrical therapeutic stimulation is parametrically defined and tuned to prevent initiation of or disrupt tachyarrhythmia upon the patient'"'"'s awakening from a sleep state through at least one of continuously-cycling, intermittent and periodic ON-OFF cycles of electrical pulses. Other operating modes, including a maintenance dose and a restorative dose are defined. The patient'"'"'s physiological state is monitored via at least one sensor to detect the patient'"'"'s awakening, which activates the delivery of the enhanced dose.

Claims

1. An implantable neurostimulator-implemented method for aiding awakening-induced 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 a patient'"'"'s cervical vagus nerve;

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

parametrically defining an enhanced dose of the electrical therapeutic stimulation tuned to prevent initiation of or disrupt tachyarrhythmia, wherein the enhanced dose comprises continuously-cycling, intermittent and periodic electrical pulses; and

parametrically defining a maintenance dose of the electrical therapeutic stimulation tuned to restore cardiac autonomic balance, wherein the maintenance dose comprises continuously-cycling, intermittent and periodic electrical pulses delivered at a lower intensity than the enhanced dose; and

monitoring a patient'"'"'s physiological state to sense a patient'"'"'s awakening from a sleep state via at least one sensor of the implantable neurostimulator, and upon sensing the patient'"'"'s awakening from the sleep state, delivering for a period of time the enhanced dose to the vagus nerve via the pulse generator through helical electrodes electrically coupled to the pulse generator via a nerve stimulation therapy lead.

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

providing a heart rate sensor as the at least one sensor comprised in the implantable neurostimulator;

establishing a normative heart rate of the patient with the heart rate sensor as a mean heart rate sensed during the sleep state;

periodically sensing the patient'"'"'s heart rate with the heart rate sensor; and

confirming that the patient is awakening from the sleep state when the patient'"'"'s heart rate gradually rises and is sustained at an elevated heart rate above the normative heart rate by a threshold amount.

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

providing an accelerometer as the at least one sensor comprised in the implantable neurostimulator;

establishing a normative activity level of the patient with the accelerometer as a mean frequency of movement sensed during the sleep state;

periodically sensing the patient'"'"'s activity level with the accelerometer; and

confirming that the patient is awakening from the sleep state when the patient'"'"'s activity level gradually rises and is sustained at an elevated activity level above the normative activity level accompanied by an increased frequency of movement by a threshold amount.

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

providing a minute ventilation sensor as the at least one sensor comprised in the implantable neurostimulator;

establishing a normative tidal volume and normative respiratory rate of the patient with the minute ventilation sensor sensed during the sleep state;

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

confirming that the patient is awakening from the sleep state when the patient'"'"'s tidal volume and respiratory rate gradually rise and are sustained at elevated levels respectively above the normative tidal volume and the normative respiratory rate by a threshold amount.

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

monitoring the patient'"'"'s normative physiology during the delivery of the enhanced dose, and upon sensing a condition indicative of an onset of tachyarrhythmia, intensifying the electrical therapeutic stimulation as specified in the operating mode.

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

progressively intensifying the electrical therapeutic stimulation as specified in the operating mode as the tachyarrhythmia continues.

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

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

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

extending the period of time of enhanced dose delivery based on determined patient'"'"'s heart response trajectory.

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

progressively intensifying the electrical therapeutic stimulation as specified in the operating mode independently of the patient'"'"'s heart response trajectory.

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

electrically stimulating the cervical vagus nerve after an expiration of the period of time, comprising one of;

upon detecting the presence of the condition indicative of the tachyarrhythmia after an expiration of the period of time, switching to delivering a restorative dose to the vagus nerve via the pulse generator through the pair of helical electrodes; and

upon detecting an absence of the condition indicative of tachyarrhythmia after the expiration of the time period, switching to delivering the maintenance dose to the vagus nerve via the pulse generator through the pair of helical electrodes,

wherein the storing the operating mode of the pulse generator in the recordable memory further comprises parametrically defining the 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 a higher intensity than the maintenance dose.

11. A method according to claim 10, further comprising at least of:

defining the intensity of the enhanced dose as comprising one or more of an output current, a duty cycle, a frequency, and a pulse width;

defining the lower intensity of the maintenance dose as comprising one or more of an output current lower than the enhanced dose output current, a duty cycle lower than the enhanced dose duty cycle, a frequency lower than the enhanced dose frequency, and a pulse width shorter than the enhanced dose pulse width; and

defining the higher intensity of the restorative dose as comprising one or more of an output current higher than the maintenance dose output current, a duty cycle higher than the maintenance dose duty cycle, a frequency higher than the maintenance dose frequency, and a pulse length longer than the maintenance pulse length.

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

providing a magnetically-actuated reed switch configured to control the pulse generator; and

controlling the pulse generator in response to a magnetic signal remotely applied to the reed switch, comprising at least one of;

switching between delivery of the maintenance dose, the enhanced dose, and the restorative dose;

triggering or increasing delivery of either the maintenance dose, the enhanced dose, and the restorative dose; and

decreasing or suspending delivery of either the maintenance dose, the enhanced dose, and the restorative dose.

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

titrating the electrical therapeutic stimulation when beginning or suspending the delivery of the enhanced dose.

14. A method according to claim 1, defining the enhanced dose further comprising at least one of:

monitoring the patient'"'"'s normative physiology during the delivery of the enhanced dose, and suspending the electrical therapeutic stimulation as specified in the operating mode upon a presence of a bradyarrhythmia.

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