Implantable neurostimulator-implemented method for enhancing post-exercise recovery through vagus nerve stimulation

• US 9,643,008 B2
• Filed: 11/09/2012
• Issued: 05/09/2017
• 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): Alter, Alyssa M
• Application Number:
  US13/673,795
• Publication Number:
  US 20140135863A1
• Time in Patent Office: 1,642 Days
• Field of Search: 607 14
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 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 enhancing post-exercise recovery through vagus nerve stimulation is provided. An implantable neurostimulator, including 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 including a patient'"'"'s cervical vagus nerve. An operating mode is stored in the pulse generator. An enhanced dose of the electrical therapeutic stimulation is parametrically defined and tuned to prevent or disrupt tachyarrhythmia through continuously-cycling, intermittent and periodic electrical pulses. The patient'"'"'s physiological state is monitored during physical exercise via at least one sensor included in the implantable neurostimulator, and upon sensing a condition indicative of cessation of the physical exercise, the enhanced dose is delivered for a period of time the enhanced dose to the vagus nerve.

Claims

1. An implantable neurostimulator-implemented method for enhancing post-exercise recovery 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 comprising a patient'"'"'s cervical vagus nerve;

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

parametrically defining an enhanced dose of the electrical therapeutic stimulation tuned to prevent or disrupt tachyarrhythmia through intermittent and periodic electrical pulses; and

parametrically defining a maintenance dose of the electrical therapeutic stimulation delivered at a lower intensity than the enhanced dose; and

monitoring the patient'"'"'s physiological state during physical exercise via at least one sensor comprised in the implantable neurostimulator, and upon sensing a condition indicative of cessation of the physical exercise, delivering for a period of time the enhanced dose to the vagus nerve.

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 non-exertion periods exclusive of the physical exercise;

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

confirming that the patient is undergoing the physical exercise when the patient'"'"'s heart rate gradually rises and is sustained at an elevated heart rate above the normative heart rate; and

subsequently confirming the cessation of the physical exercise when the patient'"'"'s heart rate falls below the elevated 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 non-exertion periods exclusive of the physical exercise;

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

confirming that the patient is undergoing the physical exercise 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; and

subsequently confirming the cessation of the physical exercise when the patient'"'"'s activity level falls below the elevated activity level accompanied by a decreased 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 non-exertion periods exclusive of the physical exercise;

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

confirming that the patient is undergoing the physical exercise 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; and

subsequently confirming the cessation of the physical exercise when the patient'"'"'s tidal volume and respiratory rate fall below the respective elevated levels by a threshold amount.

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

monitoring the patient'"'"'s physiological state throughout the delivering 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:

delivering the maintenance dose to the vagus nerve via the pulse generator through a pair of helical electrodes following the delivering of the enhanced dose,

wherein storing the operating mode of the pulse generator in the recordable memory further comprises parametrically defining the maintenance dose of the electrical therapeutic stimulation tuned to restore cardiac autonomic balance through intermittent and periodic electrical pulses.

9. A method according to claim 8, 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 enhanced dose and the maintenance dose;

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

decreasing or suspending delivery of either the enhanced dose or the maintenance dose.

10. A method according to claim 1, wherein the maintenance dose comprises one or more of the following:

a lower output current than the enhanced dose, a lower duty cycle than the enhanced dose, a lower frequency than the enhanced dose, or a shorter pulse width than the enhanced dose.

11. An implantable neurostimulator-implemented method for adaptively enhancing post-exercise recovery 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 comprising a patient'"'"'s cervical vagus nerve;

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

parametrically defining an enhanced dose of the electrical therapeutic stimulation tuned to prevent or disrupt tachyarrhythmia through intermittent and periodic electrical pulses; and

parametrically defining a maintenance dose of the electrical therapeutic stimulation delivered at a lower intensity than the enhanced dose;

monitoring the patient'"'"'s physiological state during physical exercise via at least one sensor comprised in the implantable neurostimulator; and

upon sensing a condition indicative of cessation of the physical exercise, delivering the enhanced dose to the vagus nerve, comprising;

monitoring the patient'"'"'s physiological state throughout the delivering of the enhanced dose with the at least one sensor and establishing a heart response trajectory based on the patient'"'"'s physiological state; and

continuing the delivering of the enhanced dose while the heart response trajectory remains elevated.

12. A method according to claim 11, 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 non-exertion periods exclusive of the physical exercise;

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

confirming that the patient is undergoing the physical exercise when the patient'"'"'s heart rate gradually rises and is sustained at an elevated heart rate above the normative heart rate; and

subsequently confirming the cessation of the physical exercise when the patient'"'"'s heart rate falls below the elevated heart rate by a threshold amount.

13. A method according to claim 11, 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 non-exertion periods exclusive of the physical exercise;

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

confirming that the patient is undergoing the physical exercise 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; and

subsequently confirming the cessation of the physical exercise when the patient'"'"'s activity level falls below the elevated activity level accompanied by a decreased frequency of movement by a threshold amount.

14. A method according to claim 11, 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 non-exertion periods exclusive of the physical exercise;

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

confirming that the patient is undergoing the physical exercise 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; and

subsequently confirming the cessation of the physical exercise when the patient'"'"'s tidal volume and respiratory rate fall below the respective elevated levels by a threshold amount.

15. A method according to claim 11, further comprising the step of:

monitoring the patient'"'"'s physiological state throughout the delivering 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.

16. A method according to claim 15, further comprising the step of:

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

17. A method according to claim 15, 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.

18. A method according to claim 11, further comprising the step of:

delivering the maintenance dose to the vagus nerve via the pulse generator through a pair of helical electrodes following the delivering of the enhanced dose,

wherein storing the operating mode of the pulse generator further comprises parametrically defining the maintenance dose of the electrical therapeutic stimulation tuned to restore cardiac autonomic balance through intermittent and periodic electrical pulses.

19. A method according to claim 18, 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 enhanced dose and the maintenance dose;

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

decreasing or suspending delivery of either the enhanced dose or the maintenance dose.

20. A method according to claim 11, wherein the maintenance dose comprises one or more of the following:

a lower output current than the enhanced dose, a lower duty cycle than the enhanced dose, a lower frequency than the enhanced dose, or a shorter pulse width than the enhanced dose.