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

Patent metadata

Field	Value
Publication number	US-10159840-B2
Application number	US-201514806046-A
Country	US
Kind code	B2
Filing date	Jul 22, 2015
Priority date	Jul 23, 2014
Publication date	Dec 25, 2018
Grant date	Dec 25, 2018

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. An active implantable medical device for providing neurostimulation therapy to a patient, comprising:
a physiological sensor;
a generator configured to produce the neurostimulation therapy comprising stimulation pulse sequences generated continuously in succession during activity periods separated by intermediate inactivity periods during which no stimulation is issued; and
circuitry configured to:
receive an input signal, provided by the physiological sensor, representative of cardiac activity and/or a hemodynamic status of the patient, and output to the generator a control parameter of an efficiency of the neurostimulation therapy;
detect for an occurrence of at least one predetermined event;
following an initial inactivity period, trigger an initial activity period after failing to detect the occurrence of the at least one predetermined event; and
provide for dynamic control of the neurostimulation therapy by:
modulating a duration of the activity period for each stimulation pulse sequence; and
calculating at the end of each activity period a duration of the inactivity period depending on the duration of the preceding activity period;

wherein the circuitry is configured to modulate the duration of the activity period by:
calculating a threshold value for the control parameter for each current activity period, wherein the threshold value is determined from a sole peak value for the control parameter or is based on a subtraction of a base value from a peak value for the control parameter;
monitoring a crossing of the threshold value by a current value level of the control parameter; and
ending the activity period when the threshold value is crossed.

2. The device of claim 1 , wherein the circuitry is configured to modulate durations of the inactivity periods so as to maintain a constant duty cycle ratio between the activity periods and the inactivity periods.

3. The device of claim 1 , wherein the circuitry is further configured to:
monitor for each of a plurality of cardiac cycles the crossing of the threshold value by the current value level of the control parameter; and
end at each of the plurality of cardiac cycles the activity period if the threshold value is crossed.

4. The device of claim 1 , wherein the peak value is a peak value of the control parameter achieved during the current activity period.

5. The device of claim 1 , wherein the threshold is calculated based on the subtraction of a base value of the control parameter before a triggering of the current activity period and a peak value of the control parameter reached during the current activity period.

6. The device of claim 4 , wherein the base value of the control parameter is a mean value calculated over a certain number of cycles during the inactive period just prior to the current activity period.

7. The device of claim 1 , wherein the circuitry is further configured to inhibit triggering of a stimulation pulse sequence by the generator in case of occurrence of the at least one predetermined event.

8. The device of claim 7 , wherein the at least one predetermined event is at least one of a cough, ventricular extrasystole, or apnea.

9. The device of claim 7 , wherein the circuitry further provides for a timing control, adapted to unconditionally stop the generation of the stimulation pulse sequence after lapse of a predetermined period.

10. The device of claim 1 , wherein the generator is configured to provide the neurostimulation therapy via stimulation of the vagus nerve.

11. The device of claim 1 , wherein the threshold value is a percentage of the subtraction of the base value from the peak value for the control parameter.

12. The device of claim 11 , wherein the base value is a mean value calculated over a certain number of cycles during the inactive period just prior to the current activity period, and wherein the peak value is a peak value of the control parameter reached during the current activity period.

13. A method of providing neurostimulation therapy to a patient, comprising:
producing, using a generator, the neurostimulation therapy comprising stimulation pulse sequences continuously in succession during activity periods separated by intermediate inactivity periods during which no stimulation is issued;
receiving, using circuitry, an input signal, from a physiological sensor, representative of cardiac activity and/or a hemodynamic status of the patient;
outputting, using the circuitry, a control parameter of an efficiency of the neurostimulation therapy;
determining, using circuitry, that no predetermined event is occurring;
following an initial inactivity period and after determining that no predetermined event has occurred, modulating, using the circuitry, a duration of an activity period for each stimulation pulse sequence based on a current value level of the control parameter; and
calculating, at an end of each activity period using the circuitry, a duration of an inactivity period depending on the duration of a preceding activity period;
wherein modulating the duration of the activity period for each stimulation pulse sequence comprises:
calculating a threshold value for the control parameter for each current activity period, wherein the threshold value is determined from a sole peak value for the control parameter or is based on a subtraction of a base value from a peak value for the control parameter;
monitoring a crossing of the threshold value by the current value level of the control parameter; and
ending the activity period when the threshold value is crossed.

14. The method of claim 13 , further comprising modulating durations of the inactivity periods to maintain a constant duty cycle ratio between the activity periods and the inactivity periods.

15. The method of claim 13 , wherein the peak value is a peak value of the control parameter achieved during the current activity period.

16. The method of claim 13 , wherein the threshold is calculated based on the subtraction of a base value of the control parameter before a triggering of the current activity period from a peak value of the control parameter reached during the current activity period.

17. The method of claim 16 , wherein the base value of the control parameter is a mean value calculated over a certain number of cycles during the inactive period just prior to the current activity period.

18. The method of claim 13 , wherein the threshold value is a percentage of the subtraction of the base value from the peak value for the control parameter.

19. The method of claim 18 , wherein the base value is a mean value calculated over a certain number of cycles during the inactive period just prior to the current activity period, and wherein the peak value is a peak value of the control parameter reached during the current activity period.

Assignees

• Sorin Crm Sas
• Univ Rennes
• Inserm—Institut National De La Sante Et De La Rech Medicale
• Inst Nat Sante Rech Med

Inventors

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

Classifications

• A61N1/36146

  specified by the stimulation parameters · CPC title

• A61N1/36053

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

• A61N1/36139 Primary

  with automatic adjustment · CPC title

• A61N1/36167

  Timing, e.g. stimulation onset · CPC title

• A61N1/36114

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