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

• US 10,004,903 B2
• Filed: 01/19/2017
• Issued: 06/26/2018
• 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
• Application Number:
  US15/410,316
• Publication Number:
  US 20170128727A1
• Time in Patent Office: 523 Days
• 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 that 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 pulsed electrical signals;

a lead;

an electrode communicatively coupled to the pulse generator via the lead, wherein the pulse generator is configured to apply the pulsed electrical signal to a vagus nerve via the electrode;

a sensor configured to monitor the patient'"'"'s physiological state;

a processor configured to;

deliver a maintenance dose comprising a first pulsed electrical signal with first stimulation parameters comprising a first intensity configured to restore cardiac autonomic balance;

detect an awakening of the patient using data from the sensor;

after detecting the awakening of the patient, deliver an enhanced dose comprising a second pulsed electrical signal with second stimulation parameters comprising a second intensity configured to prevent a tachycardia event, wherein the second intensity is greater than the first intensity;

detect the tachycardia event using data from the sensor;

deliver a restorative dose comprising a third pulsed electrical signal with third stimulation parameters comprising a third intensity configured to disrupt the tachycardia event, wherein the third intensity is greater than the second intensity;

monitor an efficacy of the restorative dose disrupting the tachycardia event; and

modify at least one of the third stimulation parameters of the restorative dose in response to determining the restorative dose is not efficacious based on the monitored efficacy.

2. The neurostimulator of claim 1, wherein modifying at least one of the third stimulation parameters of the restorative dose comprises modifying at least one of an intensity, amplitude, frequency, pulse width, duration or duty cycle of the third stimulation parameters.

3. The neurostimulator of claim 1, wherein the third intensity is modified by increasing the third intensity.

4. The neurostimulator of claim 3, wherein the third intensity is modified by increasing the third intensity incrementally until a maximum intensity is reached.

5. The neurostimulator of claim 1, wherein the sensor is a heart rate sensor.

6. The neurostimulator of claim 1, wherein the processor is further configured to extend a period of time of the restorative dose delivery based on a heart response trajectory of the patient determined by the processor using data from the sensor.

7. The neurostimulator of claim 1, wherein the processor is further configured to resume delivery of the maintenance dose in response to detecting an absence of the tachycardia event.

8. The neurostimulator of claim 1, wherein the processor is further configured to suspend delivery of the enhanced dose in response to detecting a bradycardia event.

9. A method of managing tachycardia of a patient through vagus nerve stimulation using an implantable medical device, the method comprising:

delivering, via an electrode coupled to a pulse generator of the implantable medical device, a maintenance dose with first stimulation parameters comprising a first intensity that is configured to restore cardiac autonomic balance;

detecting, using a sensor, an awakening of the patient;

after detecting the awakening of the patient, delivering, via the electrode coupled to the pulse generator of the implantable medical device, an enhanced dose comprising a second pulsed electrical signal with second simulation parameters comprising a second intensity configured to prevent a tachycardia event, wherein the second intensity is greater than the first intensity;

detecting, using the sensor, the tachycardia event;

delivering, via the electrode coupled to the pulse generator of the implantable medical device, a restorative dose with third stimulation parameters comprising a third intensity that is configured to disrupt the tachycardia event, wherein the third intensity is greater than the second intensity;

monitoring, using a processor of the implantable medical device, an efficacy of the restorative dose disrupting the tachycardia event; and

modifying, using the processor, at least one of the third stimulation parameter of the enhanced dose in response to determining the restorative dose is not efficacious based on the monitored efficacy.

10. The neurostimulator of claim 9, wherein modifying at least one of the third stimulation parameters of the restorative dose comprises modifying at least one of an intensity, amplitude, frequency, pulse width, duration or duty cycle of the third stimulation parameters.

11. The neurostimulator of claim 9, wherein the third intensity is modified by increasing the third intensity.

12. The neurostimulator of claim 11, wherein the third intensity is modified by increasing the third intensity incrementally until a maximum intensity is reached.

13. The neurostimulator of claim 9, wherein the sensor is a heart rate sensor.

14. The neurostimulator of claim 9, wherein the processor is further configured to extend a period of time of the restorative dose delivery based on a heart response trajectory of the patient determined using data from the sensor.

15. The neurostimulator of claim 9, wherein the processor is further configured to resume delivery of the maintenance dose in response to detecting an absence of the tachycardia event.

16. The neurostimulator of claim 9, wherein the processor is further configured to suspend delivery of the enhanced dose in response to detecting a bradycardia event.

17. A non-transitory computer-readable medium comprising instructions executable by a processor of an implantable medical device to perform operations, the operations comprising:

deliver, via an electrode coupled to a pulse generator of the implantable medical device, a maintenance dose with first stimulation parameters comprising a first intensity that is configured to restore cardiac autonomic balance;

detecting, using a sensor, an awakening of the patient;

after detecting the awakening of the patient, delivering, via the electrode coupled to the pulse generator, an enhanced dose comprising a second pulsed electrical signal with second simulation parameters comprising a second intensity configured to prevent a tachycardia event, wherein the second intensity is greater than the first intensity;

detecting, using the sensor, the tachycardia event;

delivering, via the electrode coupled to the pulse generator a restorative dose with third stimulation parameters comprising a third intensity that is configured to disrupt the tachycardia event, wherein the third intensity is greater than the second intensity;

monitor an efficacy of the restorative dose disrupting the tachycardia event;

modify at least one of the third stimulation parameters of the enhanced dose in response to determining the restorative dose is not efficacious based on the monitored efficacy.

18. The non-transitory computer-readable medium of claim 17, wherein modifying at least one of the third stimulation parameters of the restorative dose comprises modifying at least one of an intensity, amplitude, frequency, pulse width, duration or duty cycle of the second stimulation parameters.

19. The non-transitory computer-readable medium of claim 17, wherein the third intensity is modified by increasing the third intensity.

20. The non-transitory computer-readable medium of claim 17, wherein the third is modified by increasing the third incrementally until a maximum intensity is reached.