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

• US 10,384,065 B2
• Filed: 05/03/2017
• Issued: 08/20/2019
• Est. Priority Date: 11/09/2012
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Inventors: Libbus, Imad, Amurthur, Badri, Kenknight, Bruce H.
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US15/585,958
• Publication Number:
  US 20170296822A1
• Time in Patent Office: 839 Days
• 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. A method for enhancing post-exercise recovery through vagus nerve stimulation, comprising the steps of:

providing an implantable neurostimulator comprising a sensor and a pulse generator configured to deliver electrical therapeutic stimulation to a cervical vagus nerve of a patient;

storing operating modes of the pulse generator in a recordable memory, the operating modes defining;

an enhanced dose of the electrical therapeutic stimulation comprising a first intensity; and

a maintenance dose of the electrical therapeutic stimulation comprising a second intensity lower than the first intensity;

delivering the maintenance dose to the vagus nerve during a non-exertion period of the patient;

monitoring a physiological state of the patient during physical exercise via the sensor; and

upon sensing a condition indicative of cessation of the physical exercise based on the monitored physiological state, delivering the enhanced dose to the vagus nerve.

2. A method according to claim 1, wherein the sensor comprises a heart rate sensor, the method further comprising the steps of:

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 a heart rate of the patient with the heart rate sensor;

confirming that the patient is undergoing the physical exercise when the 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 heart rate falls below the elevated heart rate by a threshold amount.

3. A method according to claim 1, wherein the sensor comprises an accelerometer, the method further comprising the steps of:

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 an activity level of the patient with the accelerometer;

confirming that the patient is undergoing the physical exercise when the 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 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, wherein the sensor comprises a minute ventilation sensor, the method further comprising the steps of:

establishing a normative tidal volume and a normative respiratory rate of the patient with the minute ventilation sensor sensed during non-exertion periods exclusive of the physical exercise;

periodically sensing a tidal volume and a respiratory rate of the patient with the minute ventilation sensor;

confirming that the patient is undergoing the physical exercise when the 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 tidal volume and respiratory rate fall below the respective elevated levels by a threshold amount.

5. A method according to claim 1, further comprising monitoring the 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 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 increasing the electrical therapeutic stimulation to a highest level specified in the operating mode in response to the tachyarrhythmia failing to respond to the intensified electrical therapeutic stimulation.

8. A method according to claim 1, further comprising 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.

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 by 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. A neurostimulator system for enhancing post-exercise recovery through vagus nerve stimulation, comprising:

a sensor; and

a neurostimulator comprising a pulse generator configured to deliver electrical therapeutic stimulation to a patient'"'"'s cervical vagus nerve and a recordable memory comprising instructions that cause the pulse generator to;

deliver a maintenance dose of the electrical therapeutic stimulation during a non-exertion period of the patient;

monitor a physiological state of the patient during physical exercise via the sensor; and

upon sensing a condition indicative of cessation of the physical exercise based on the monitored physiological state, suspend delivery of the maintenance dose and deliver an enhanced dose of the electrical therapeutic stimulation to the vagus nerve, the enhanced dose comprising a first intensity and the maintenance dose comprising a second intensity lower than the first intensity.

12. A system according to claim 11, wherein the sensor comprises a heart rate sensor, and the recordable memory further comprises instructions that cause the pulse generator to:

establish 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 sense a heart rate of the patient with the heart rate sensor;

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

subsequently confirm the cessation of the physical exercise when the heart rate falls below the elevated heart rate by a threshold amount.

13. A system according to claim 11, wherein the sensor comprises an accelerometer, and the recordable memory further comprises instructions that cause the pulse generator to:

establish 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 sense an activity level of the patient with the accelerometer;

confirm that the patient is undergoing the physical exercise when the 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 confirm the cessation of the physical exercise when the activity level falls below the elevated activity level accompanied by a decreased frequency of movement by a threshold amount.

14. A system according to claim 11, wherein the sensor comprises a minute ventilation sensor, and the recordable memory further comprises instructions that cause the pulse generator to:

establish 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 sense a tidal volume and a respiratory rate with the minute ventilation sensor;

confirm that the patient is undergoing the physical exercise when the 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 confirm the cessation of the physical exercise when the tidal volume and respiratory rate fall below the respective elevated levels by a threshold amount.

15. A system according to claim 11, wherein the recordable memory further comprises instructions that cause the pulse generator to monitor the 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.

16. A non-transitory computer-readable medium having instructions stored thereon that, when executed by a processor of an implantable medical device, cause the processor to:

deliver, via the pulse generator, a maintenance dose of the electrical therapeutic stimulation at a second intensity lower than a first intensity of an enhanced dose during a non-exertion period of the patient;

monitor, via a sensor of the implantable medical device, a physiological state of a patient during physical exercise; and

upon sensing a condition indicative of cessation of the physical exercise based on the monitored physiological state, suspend delivery of the maintenance dose and deliver the enhanced dose to a vagus nerve of the patient.

17. A non-transitory computer-readable medium according to claim 16, wherein the sensor comprises a heart rate sensor, and wherein the instructions cause the processor to:

establish 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 sense a heart rate of the patient with the heart rate sensor;

confirm that the patient is undergoing the physical exercise when the heart rate of the patient gradually rises and is sustained at an elevated heart rate above the normative heart rate; and

subsequently confirm the cessation of the physical exercise when the heart rate of the patient falls below the elevated heart rate by a threshold amount.

18. A non-transitory computer-readable medium according to claim 16, wherein the sensor comprises an accelerometer, and wherein the instructions cause the processor to:

establish 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 sense an activity level of the patient with the accelerometer;

confirm that the patient is undergoing the physical exercise when the activity level of the patient gradually rises and is sustained at an elevated activity level above the normative activity level accompanied by an increased frequency of movement; and

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

19. A non-transitory computer-readable medium according to claim 16, wherein the sensor comprises a minute ventilation sensor, and wherein the instructions cause the processor to:

establish a normative tidal volume and a normative respiratory rate of the patient with the minute ventilation sensor sensed during non-exertion periods exclusive of the physical exercise;

periodically sense a tidal volume and a respiratory rate of the patient with the minute ventilation sensor;

confirm that the patient is undergoing the physical exercise when the tidal volume and respiratory rate of the patient gradually rise and are sustained at elevated levels respectively above the normative tidal volume and the normative respiratory rate; and

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

20. A non-transitory computer-readable medium according to claim 16, wherein the instructions further cause the processor to monitor the physiological state of the patient throughout the delivering of the enhanced dose, and upon sensing a condition indicative of an onset of tachyarrhythmia, intensify the electrical therapeutic stimulation.