Active implantable medical device for treating sleep apnea syndrome by electrostimulation

• US 6,574,507 B1
• Filed: 03/06/2000
• Issued: 06/03/2003
• Est. Priority Date: 07/06/1998
• Status: Expired due to Term

• Current Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Original Assignee: Ela Medical S.A. (LivaNova Plc)
• Inventors: Bonnet, Jean-Luc
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US09/508,068
• Time in Patent Office: 1,184 Days
• Field of Search: 600/508, 600/509, 600/529, 600/547, 607/9, 607/11, 607/16, 607/17, 607/20, 607/119, 607/42
• US Class Current: 607/20
• CPC Class Codes: A61M 16/00 Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes stimulating the respiratory movement by mechanical, pneumatic or electrical means, iron lungs combined with gas breathing means A61H31/00
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood

Abstract

An active implantable medical device for electrostimulation in response to a determined sleep apnea syndrome, particularly a pacemaker. This device measures the respiratory activity of the patient, using for example, a minute ventilation sensor and/or a blood oxygen saturation sensor, and analyzes the sensor signal, to determine occurrence of an apnea according to the signal delivered by the sensor. The device also delivers an increase cardiiac pacing rate in the event of detection of apnea. The device also can deliver a neurological and/or cardiac stimulation so as to apply selectively to the patient an electric stimulus. The device also determines the patients'"'"'s state of activity, according to predetermined criteria, such that the increased pacing rate is provided only during a sleep phase and otherwise inhibited. The analysis can in particular detect and occurrence of successive apnea during a phase of sleep and determine the occurrence of a sleep apnea syndrome when the number of apnea events detected during a given period of time exceeds a predetermined threshold.

Claims

1. A cardiac stimulation device for treating the syndrome of the sleep apnea of a patient by electrostimulation comprising:

means for measuring the respiratory activity of the patient having an output signal representative of the patient'"'"'s respiratory activity;

means for analyzing the patient'"'"'s respiratory activity according to the output signal from the respiratory measuring means to determine an occurrence of an apnea;

means for determining a cardiac rate of the patient, including a second rate in the absence of a determined apnea;

means for stimulation, controlled by the analyzing means, to apply selectively to the patient cardiac stimuli at a first rate in the event of a detection of an apnea, said first rate being higher than the second rate;

means for determining a state of activity of the patient, said state being selected, according to predetermined criteria, from among a first value representative of a sleep state of the patient and a second value representative of an awake state of the patient;

wherein the stimulation means is applying to the patient cardiac stimuli at the first cardiac rate only during a determined sleep phase.

2. The device of claim 1 in which the stimulation means stimulates in response to being triggered at the first rate, wherein the first rate is at least 10 beats higher than the second rate.

3. The device of claim 1, in which the analyzing means detects an occurrence of successive apnea during a sleep phase and determines an occurrence of a syndrome of apnea of the sleep when the number of apnea detected during a given period of time exceeds a predetermined threshold.

4. The device of claim 1, in which the means of determination of a state of activity further comprises analyzing the output signal from said measuring means.

5. The device of claim 1, further comprising an auxiliary measuring means for measuring a state of activity of the patient;

wherein the means for determining the state of activity further comprises means for analyzing the output signal from the auxiliary measuring means, said auxiliary measuring means output signal being distinct from said means for measuring of the respiratory activity of the patient.

6. The device of claim 1, further comprising an auxiliary means for measuring a state of activity of the patient, wherein said auxiliary measuring means further comprises an accelerometer.

7. The device of claim 1, wherein the means for measuring the respiratory activity of the patient further comprises a minute ventilation sensor.

8. The device of claim 1, wherein the means for measuring the respiratory activity of the patient further comprises a sensor of oxygen saturation of blood.

9. A cardiac stimulation device for treating a sleep apnea syndrome of a patient by electrostimulation comprising:

means for determining a state of activity of the patient, said state being selected, according to predetermined criteria, from among a first value representative of a sleep state of the patient and a second value representative of an awake state of the patient;

means for measuring the respiratory activity of the patient;

means for determining an occurrence of an apnea based upon said measured respiratory activity;

means for determining a cardiac rate of the patient during an identified sleep state as a second rate;

means for providing a first rate for cardiac stimulation as the second rate incremented by a first number of beats per minute; and

means for selectively applying cardiac stimulation at said first rate to the patient in response to a determined apnea during a sleep state.

10. The device of claim 9 wherein the first number of beats is at least 10 beats per minute.

11. The device of claim 10 wherein the first number of beats is 10 beats per minute.

12. The device of claim 9, wherein the apnea determining means determines an occurrence of successive apnea during a sleep phase and determines an occurrence of a syndrome of sleep apnea when the number of apnea detected during a given period of time exceeds a predetermined threshold.

13. The device of claim 9, wherein the means for determining a state of activity further comprises means for analyzing the measured respiration activity.

14. The device of claim 9, further comprising an auxiliary measuring means for measuring a state of activity of the patient having output signal;

wherein the means for determining the state of activity further comprises means for analyzing the output signal from the auxiliary measuring means, said auxiliary measuring means output signal being distinct from said means for measuring of the respiratory activity of the patient.

15. The device of claim 14, wherein said auxiliary means for measuring a state of activity further comprises an accelerometer.

16. The device of claim 9, further comprising an auxiliary means for measuring a state of activity of the patient, wherein said auxiliary measuring means further comprises an accelerometer.

17. The device of claim 9, wherein the means for measuring the respiratory activity of the patient further comprises a minute ventilation sensor.

18. The device of claim 9, wherein the means for measuring the respiratory activity of the patient further comprises a sensor of oxygen saturation of blood.

19. The device of claim 9, wherein the means for selectively applying cardiac stimulation at said first rate applies said first rate for a predetermined time.

20. The device of claim 9, wherein the means for determining said second rate further comprises means for determining a natural sinusal rate of the patient.

21. A cardiac stimulation device for treating a sleep apnea syndrome of a patient by electrostimulation comprising:

a patient activity detector having predetermined criteria corresponding to a sleep state of a patient and an awake state of the patient, said detector monitoring patient activity and producing a first state output when the patient is in a sleep state and a second state output when the patient is in an awake state;

a respiratory activity monitor having a first activity output corresponding to a patient'"'"'s respiratory activity;

an apnea detector responsive to said first activity output for determining an occurrence of an apnea based upon said patient respiratory activity;

a cardiac rate monitor for determining a first cardiac rate of the patient in response to the patient activity monitor producing the first state output;

a cardiac stimulator having a second cardiac stimulation rate output corresponding to the determined first cardiac rate incremented by a first number of beats per minute, said stimulator applying cardiac stimulation at said cardiac stimulation rate to the patient in response to a determined apnea and the patient activity monitor producing the first state output.

22. The device of claim 21 wherein the first number of beats is at least 10 beats per minute.

23. The device of claim 22 wherein the first number of beats is 10 beats per minute.

24. The device of claim 21, wherein the apnea detector has a predetermined count and a given time period and determines an occurrence of a syndrome of sleep apnea occurrences when the number of apnea detected while the patient activity monitor produces the first state output during the given period of time exceeds the predetermined count.

25. The device of claim 21, wherein the patient activity detector further comprises means for analyzing a respiratory activity monitor output.

26. The device of claim 21, further comprising an auxiliary patient activity monitor distinct from said respiratory activity monitor having a second activity output corresponding to a state of activity of the patient;

wherein the means for determining the state of activity further comprises means for analyzing the second activity output in determining the patient'"'"'s activity state.

27. The device of claim 26, wherein said auxiliary patient activity monitor further comprises an accelerometer.

28. The device of claim 21, wherein the respiratory activity monitor further comprises an electrode pair, a current injector connected in the electrode pair, a voltage detector connected to the electrode pair, and a controller operating the current injector to inject a current pulse and the voltage detector to detect a voltage in response to the current, wherein the controller calculates a minute ventilation based on the detected voltages.

29. The device of claim 21, wherein the respiratory activity monitor further comprises a sensor of oxygen saturation of blood.

30. The device of claim 21, wherein the cardiac stimulator applies cardiac stimulation at said cardiac stimulation rate for a predetermined time.

31. The device of claim 21, wherein the cardiac rate monitor determines a natural sinusal rate of the patient as said first cardiac rate.