Active implantable medical device for nerve stimulation therapy with dynamic adjustment of stimulation periods

Patent metadata

Field	Value
Publication number	US-11389656-B2
Application number	US-201816229281-A
Country	US
Kind code	B2
Filing date	Dec 21, 2018
Priority date	Jul 23, 2014
Publication date	Jul 19, 2022
Grant date	Jul 19, 2022

Abstract

An active implantable medical device for neurostimulation therapy is disclosed. The device produces stimulation pulse sequences generated continuously in succession during activity periods separated by intermediate inactivity periods during which no stimulation is issued. An input signal, provided by a physiological sensor, representative of cardiac activity and/or of the patient's hemodynamic status is received by circuitry. The circuitry further provides for dynamic control of the neurostimulation therapy, wherein the length of activity periods is modulated based on the current value level of the control parameter compared to a threshold. The duration of the next period of inactivity is calculated by the circuitry at the end of each activity period to maintain a constant duty cycle ratio between periods of activity and periods of inactivity.

First claim

What is claimed is:

1. A method of providing neurostimulation therapy to a patient, the method comprising:
checking if conditions are met to allow initiation of an activity period during which stimulation is applied to the patient;
initiating the activity period in response to the conditions being met;
monitoring a physiological control parameter representative of at least one of cardiac activity or a hemodynamic status of the patient, wherein a base value of the physiological control parameter is monitored before the activity period and a peak value of the physiological control parameter is monitored during the activity period;
calculating a threshold value for the physiological control parameter based on the peak value or based on a subtraction of the base value from the peak value; and
terminating the activity period in response to a first of the physiological control parameter falling below the threshold value or a maximum duration of the activity period being reached.

2. The method of claim 1 , further comprising calculating a duration of an inactivity period during which no stimulation is generated subsequent to the activity period.

3. The method of claim 2 , wherein calculating the duration of the subsequent inactivity period comprises calculating the duration of the subsequent inactivity period to maintain a constant duty cycle ratio between the inactivity period and the activity period.

4. The method of claim 3 , wherein the constant duty cycle ratio is that the duration of the inactivity period is three times a duration of the activity period.

5. The method of claim 2 , further comprising initiating the inactivity period subsequent to the termination of the activity period.

6. The method of claim 5 , further comprising:
after the duration of the inactivity period, checking if the conditions are met to allow initiation of a second activity period during which stimulation is applied to the patient; and
activating a second inactivity period during which no stimulation is generated in response to the conditions not being met.

7. The method of claim 6 , further comprising maintaining the second inactivity period for a predetermined duration.

8. The method of claim 1 , wherein the stimulation is provided via stimulation of a vagus nerve of the patient.

9. The method of claim 1 , wherein checking if the conditions are met comprises checking for an absence of at least one of a cough, an apnea event, or ventricular ectopic beats.

10. The method of claim 1 , wherein the physiological control parameter is an RR interval.

11. An active implantable medical device for providing neurostimulation therapy to a patient, the active implantable medical device comprising:
a generator configured to produce the neurostimulation therapy comprising stimulation generated during activity periods separated by inactivity periods during which no stimulation is generated; and
circuitry configured to:
check if conditions are met to allow initiation of an activity period;
initiate the activity period in response to the conditions being met;
monitor a physiological control parameter representative of at least one of cardiac activity or a hemodynamic status of the patient, wherein a base value of the physiological control parameter is monitored before the activity period and a peak value of the physiological control parameter is monitored during the activity period;
calculate a threshold value for the physiological control parameter based on the peak value or based on a subtraction of the base value from the peak value; and
terminate the activity period in response to a first of the physiological control parameter falling below the threshold value or a maximum duration of the activity period being reached.

12. The device of claim 11 , wherein the circuitry is further configured to calculate a duration of an inactivity period subsequent to the activity period.

13. The device of claim 12 , wherein the circuitry is configured to calculate the duration of the subsequent inactivity period to maintain a constant duty cycle ratio between the inactivity period and the activity period.

14. The device of claim 13 , wherein the constant duty cycle ratio is that the duration of the inactivity period is three times a duration of the activity period.

15. The device of claim 12 , wherein the circuitry is further configured to initiate the inactivity period subsequent to the termination of the activity period.

16. The device of claim 15 , wherein the circuitry is further configured to:
after the duration of the inactivity period, check if the conditions are met to allow initiation of a second activity period during which stimulation is applied to the patient; and
activate a second inactivity period during which no stimulation is generated in response to the conditions not being met.

17. The device of claim 16 , wherein the circuitry is further configured to maintain the second inactivity period for a predetermined duration.

18. The device of claim 11 , wherein the active implantable medical device is configured to provide the stimulation to a vagus nerve of the patient.

19. The device of claim 11 , wherein the circuitry is configured to check if the conditions are met by checking for an absence of at least one of a cough, an apnea event, or ventricular ectopic beats.

20. The device of claim 11 wherein the physiological control parameter is an RR interval.

Assignees

• Sorin Crm Sas
• Univ Rennes
• Inserm—Institut National De La Sante Et De La Rech Medicale
• Univ Ie De Rennes 1

Inventors

• Bonnet Jean-Luc
• Hernandez Alfredo
• Carrault Guy
• Romero Hector

Classifications

• A61N1/36114

  Cardiac control, e.g. by vagal stimulation (stimulating the heart A61N1/362) · CPC title

• A61N1/36167

  Timing, e.g. stimulation onset · CPC title

• A61N1/36139 Primary

  with automatic adjustment · CPC title

• A61N1/36146

  specified by the stimulation parameters · CPC title

• A61N1/36053

  adapted for vagal stimulation (A61N1/36114 takes precedence) · CPC title