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

• US 9,393,419 B2
• Filed: 11/19/2014
• Issued: 07/19/2016
• 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:
  US14/547,342
• Publication Number:
  US 20150073511A1
• Time in Patent Office: 608 Days
• US Class Current: 1/1
• 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. A vagus nerve neurostimulator for modulating autonomic cardiovascular drive, comprising:

a pulse generator, wherein the pulse generator generates a pulsed electrical signal comprising;

a signal ON time;

a signal OFF time;

an output current;

a signal frequency;

a pulse width; and

a duty cycle defined by dividing the signal ON time by the sum of the signal ON time and signal OFF time;

a therapy lead;

an electrode communicatively coupled to the pulse generator via the therapy lead, wherein the pulse generator applies the electrical signal to the electrode adapted for a vagus nerve to propagate action potentials in both afferent and efferent directions along the vagus nerve at an intensity that avoids acute physiological side effects; and

a sleep monitor, wherein the sleep monitor upon sensing a change in sleep state indicative of awakening causes the pulse generator to increase an intensity of the electrical signal to deliver an enhanced pulsed electrical signal via the therapy lead and the electrode.

2. The vagus nerve neurostimulator according to claim 1, wherein the enhanced pulsed electrical signal frequency is approximately 10 Hz.

3. The vagus nerve neurostimulator according to claim 1, wherein the sleep monitor monitors a patient'"'"'s physiological state.

4. The vagus nerve neurostimulator according to claim 1, wherein the sleep monitor further comprises a heart rate sensor.

5. The vagus nerve neurostimulator according to claim 4, wherein the heart rate sensor:

establishes a normative heart rate of a patient 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 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.

6. The vagus nerve neurostimulator according to claim 5, wherein the heart rate monitor monitors the patient'"'"'s normative physiology during the delivery of the enhanced pulsed electrical signal, and upon sensing a condition indicative of an onset of tachyarrhythmia, the vagus nerve neurostimulator delivers a second enhanced pulsed electrical signal.

7. The vagus nerve neurostimulator according to claim 6, wherein the heart rate monitor monitors the patient'"'"'s normative physiology during the delivery of the enhanced pulsed electrical signal, and upon sensing a condition indicative of an onset of tachyarrhythmia, intensifying the electrical therapeutic stimulation to deliver the second enhanced pulsed electrical signal.

8. The vagus nerve neurostimulator according to claim 6, wherein second enhanced pulsed electrical signal is different than the enhanced electrical signal.

9. The vagus nerve neurostimulator according to claim 1, wherein the sleep monitor further comprises an accelerometer.

10. The vagus nerve neurostimulator according to claim 9, wherein the sleep monitor:

establishes 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.

11. The vagus nerve neurostimulator according to claim 1, wherein the sleep monitor further comprises a minute ventilation sensor.

12. The vagus nerve neurostimulator according to claim 11, wherein sleep monitor:

establishes 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.

13. The vagus nerve neurostimulator according to claim 1, wherein the pulsed electrical signal further comprises a signal ramp-up time and a ramp-down time.

14. The vagus nerve neurostimulator according to claim 13, wherein the output current, the signal frequency or the pulse width of the pulsed electrical signal is modified during the ramp-up time.

15. The vagus nerve neurostimulator according to claim 13, wherein the output current, the signal frequency or the pulse width of the pulsed electrical signal is modified during the ramp-down time.

16. The vagus nerve neurostimulator according to claim 1, wherein the duty cycle comprises a value in a range of 5% to 20%.

17. The vagus nerve neurostimulator according to claim 1, wherein the sleep monitor upon sensing the change in sleep state indicative of awakening causes the pulse generator to increase the intensity of the electrical signal by increasing a frequency of the electrical signal.

18. The vagus nerve neurostimulator according to claim 1, wherein the sleep monitor upon sensing the change in sleep state indicative of awakening causes the pulse generator to increase the intensity of the electrical signal by increasing an output current of the electrical signal.

19. The vagus nerve neurostimulator according to claim 1, wherein the sleep monitor upon sensing the change in sleep state indicative of awakening causes the pulse generator to increase the intensity of the electrical signal by increasing a duty cycle of the electrical signal.

20. The vagus nerve neurostimulator according to claim 1, wherein the sleep monitor upon sensing the change in sleep state indicative of awakening causes the pulse generator to increase the intensity of the electrical signal by increasing a pulse width of the electrical signal.