Method and apparatus for modifying delivery of a therapy in response to onset of sleep

• US 7,206,635 B2
• Filed: 12/15/2003
• Issued: 04/17/2007
• Est. Priority Date: 06/07/2001
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Jensen, Donald N., Mongeon, Luc R., Cho, Yong Kyun
• Primary Examiner(s): Pezzuto; Robert E.
• Assistant Examiner(s): Oropeza; Frances P.
• Application Number:
  US10/736,370
• Publication Number:
  US 20040176809A1
• Time in Patent Office: 1,219 Days
• Field of Search: 600/373, 600/374, 600/377, 600/509, 600/513, 607 4- 7, 607/9, 607/11, 607 17- 20, 607/27, 607/116, 607/119, 607/122, 607/123
• US Class Current: 607/17
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

A method and apparatus for providing a therapy to the patient that includes a therapy component configured to provide the therapy to the patient, sensing circuitry sensing a parameter of the patient, and a microprocessor coupled to the therapy component and the sensing circuitry to determine onset of a first state of the patient in response to the sensed physiologic parameter, and to determine whether the onset of the first state is detected for a predetermined time period.

Claims

1. An implantable medical device capable of being implanted in a patient, comprising:

a therapy component configured to provide a therapy to the patient;

sensing circuitry sensing a physiologic parameter corresponding to minute ventilation values indicative of a minute ventilation of the patient; and

a microprocessor coupled to the therapy component and the sensing circuitry to detect onset of a first state of the patient in response to the sensed physiologic parameter, and to determine whether the onset of the first state is detected for a first predetermined time period, wherein the first state corresponds to an asleep state, and

wherein the microprocessor receives a plurality of the minute ventilation values at predetermined time intervals over a period of time to generate a first distribution rate of minute ventilation values of the plurality of minute ventilation values received during first time intervals m of the predetermined time intervals, including a current time interval and first preceding time intervals m-1, and a second distribution rate of minute ventilation values received during second time intervals n of the predetermined time intervals, including the current time interval and second preceding time intervals n1, wherein the onset of the first state is detected in response to the second distribution rate being greater than the first distribution rate.

2. The device of claim 1, wherein delivery of the therapy is cancelled in response to the onset of the first state not being detected for the predetermined time period.

3. The device of claim 1, wherein the therapy component senses intrinsic signals of the patient and the microprocessor detects a predetermined event in response to the sensed intrinsic signals.

4. The device of claim 3, wherein the first predetermined time period corresponds to a period of time prior to detection of the predetermined event.

5. The device of claim 4, wherein the period of time is between approximately 15 and 30 minutes.

6. The device of claim 1, wherein the first predetermined time period corresponds to a period of time since the detected onset of the first state.

7. The device of claim 6, wherein the period of time is between approximately 20 and 60 minutes.

8. The device of claim 6, wherein the therapy component senses intrinsic signals of the patient and the microprocessor detects a predetermined event in response to the sensed intrinsic signals and determines whether the predetermined event is detected subsequent to the onset of the first state being detected for the first predetermined time period.

9. The device of claim 1, wherein the microprocessor generates a threshold corresponding to a transition of the patient between the first state and a second state in response to the minute ventilation values, determines the first state is sustained in response to one of the first distribution rate not being greater than the second distribution rate, and the first distribution rate being greater than the second distribution rate and not being greater than the threshold, and determines, in response to the first state being sustained, an elapsed time since the detected onset of the first state, wherein the onset of the first state is determined to be detected for the first predetermined time period in response to the elapsed time being greater than or equal to the first predetermined time period.

10. The device of claim 9, wherein the therapy component senses intrinsic signals of the patient, and wherein the microprocessor detects a predetermined event in response to the sensed intrinsic signals, and determines whether the predetermined event is detected subsequent to the onset of the first state being detected for the first predetermined time period.

11. The device of claim 9, wherein the microprocessor determines, in response to the first state not being sustained, whether a second predetermined time period has expired, and reduces the first predetermined time period in response to the second predetermined time period being expired.

12. The device of claim 11, wherein the therapy component senses intrinsic signals of the patient and wherein the microprocessor determines, in response to the first state being sustained and the elapsed time subsequently not being greater than or equal to the first predetermined time period, whether a predetermined delivery time has been reached and the second predetermined time period has expired, detects a predetermined event in response to the sensed intrinsic signals, determines, in response to the predetermined delivery time being reached and the second predetermined time period having expired, whether the predetermined event is detected, and

delivers the therapy in response to the predetermined event being detected.

13. The device of claim 1, wherein the microprocessor generates a first threshold and a second threshold corresponding to a transition of the patient between the first state and a second state corresponding to an awake state in response to the minute ventilation values, detects onset of the first state in response to the second distribution rate being less than the first threshold and the second distribution rate being greater than or equal to the first distribution rate, and detects a transition between the first state and the second state in response to the second distribution rate being less than the first distribution rate and the first distribution rate being greater than the second threshold.

14. A method of providing therapy to a patient having an implantable medical device, comprising:

sensing a physiologic parameter corresponding to minute ventilation values indicative of a minute ventilation of the patient;

detecting onset of a first state of the patient in response to the sensed parameter, wherein the first state corresponds to an asleep state; and

determining whether the onset of the first state is detected for a first predetermined time period,

wherein detecting the onset of the first state comprises;

determining a plurality of the minute ventilation values at predetermined time intervals over a period of time;

generating a first distribution rate of minute ventilation values of the plurality of minute ventilation values received during first time intervals m of the predetermined time intervals, including a current time interval and first preceding time intervals m1, and a second distribution rate of minute ventilation values received during second time intervals n of the predetermined time intervals, including the current time interval and second preceding time intervals n1; and

detecting the onset of the first state in response to the second distribution rate being greater than the first distribution rate.

15. The method of claim 14, further comprising canceling the therapy in response to the onset of the first state not being detected for the first predetermined time period.

16. The method of claim 14, further comprising sensing intrinsic signals of the patient and detecting a predetermined event in response to the sensed intrinsic signals, wherein the first predetermined time period corresponds to a period of time prior to detection of the predetermined event.

17. The method of claim 16, wherein the period of time is between approximately 15 and 30 minutes.

18. The method of claim 14, wherein the first predetermined time period corresponds to a period of time since the detected onset of the first state.

19. The method of claim 18, wherein the period of time is between approximately 20 and 60 minutes.

20. The method of claim 18, further comprising:

sensing intrinsic signals of the patient and detecting a predetermined event in response to the sensed intrinsic signals; and

determining whether the predetermined event is detected subsequent to the onset of the first state being detected for the first predetermined time period.

21. The method of claim 14, further comprising:

generating a threshold corresponding to a transition of the patient between the first state and a second state in response to the minute ventilation values;

determining whether the first state is sustained, the first state being determined to be sustained in response to one of the first distribution rate not being greater than the second distribution rate, and the first distribution rate being greater than the second distribution rate and not being greater than the threshold; and

determining, in response to the first state being sustained, an elapsed time since the detected onset of the first state, wherein determining whether the onset of the first state is detected for a first predetermined time period comprises determining whether the elapsed time is greater than or equal to the first predetermined time period.

22. The method of claim 21, further comprising:

sensing intrinsic signals of the patient and detecting a predetermined event in response to the sensed intrinsic signals; and

determining whether the predetermined event is detected subsequent to the onset of the first state being detected for the first predetermined time period.

23. The method of claim 14, further comprising

generating a first threshold and a second threshold corresponding to a transition of the patient between the first state and a second state in response to the minute ventilation values;

and

detecting onset of the first state in response to the second distribution rate being less than the first threshold and the second distribution rate being greater than or equal to the first distribution rate, and detecting a transition between the first state and the second state in response to the second distribution rate being less than the first distribution rate and the first distribution rate being greater than the second threshold.

24. The method of claim 21, further comprising:

determining, in response to the first state not being sustained, whether a second predetermined time period has expired; and

reducing the first predetermined time period in response to the second predetermined time period being expired.

25. The method of claim 24, further comprising:

determining, in response to the first state being sustained and the elapsed time subsequently not being greater than or equal to the first predetermined time period, whether a predetermined delivery time has been reached and the second predetermined time period has expired;

sensing intrinsic signals of the patient and detecting a predetermined event in response to the sensed intrinsic signals;

determining, in response to the predetermined delivery time being reached and the second predetermined time period having expired, whether the predetermined event is detected; and

delivering the therapy in response to the predetermined event being detected.

26. An implantable medical device capable of being implanted in a patient, comprising:

means for sensing a physiologic parameter corresponding to minute ventilation values of a minute ventilation of the patient;

means for detecting onset of a first state of the patient in response to the sensed parameter, wherein the first state corresponds to an asleep state; and

means for determining whether the onset of the first state is detected for a first predetermined time period,

wherein means for detecting the onset of the first state comprises;

means for determining a plurality of the minute ventilation values at predetermined time intervals over a period of time;

means for generating a first distribution rate of minute ventilation values of the plurality of minute ventilation values received during first time intervals m of the predetermined time intervals, including a current time interval and first preceding time intervals m1, and a second distribution rate of minute ventilation values received during second time intervals n of the predetermined time intervals, including the current time interval and second preceding time intervals n1; and

means for detecting the onset of the first state in response to the second distribution rate being greater than the first distribution rate.

27. The device of claim 26, further comprising means for canceling the therapy in response to the onset of the first state not being detected for the first predetermined time period.

28. The device of claim 26, further comprising:

means for sensing intrinsic signals of the patient; and

means for detecting a predetermined event in response to the sensed intrinsic signals, wherein the predetermined time period corresponds to a period of time prior to detection of the predetermined event.

29. The device of claim 28, wherein the period of time is between approximately 15 and 30 minutes.

30. The device of claim 26, wherein the first predetermined time period corresponds to a period of time since the detected onset of the first state.

31. The device of claim 30, wherein the period of time is between approximately 20 and 60 minutes.

32. The device of claim 30, further comprising:

means for sensing intrinsic signals of the patient;

means for detecting a predetermined event in response to the sensed intrinsic signals; and

means for determining whether the predetermined event is detected subsequent to the onset of the first state being detected for the first predetermined time period.

33. The device of claim 26, further comprising:

means for generating a threshold corresponding to a transition of the patient between the first state and a second state in response to the minute ventilation values;

means for determining whether the first state is sustained, the first state being determined to be sustained in response to one of the first distribution rate not being greater than the second distribution rate, and the first distribution rate being greater than the second distribution rate and not being greater than the threshold; and

means for determining, in response to the first state being sustained, an elapsed time since the detected onset of the first state, wherein the means for determining whether the onset of the first state is detected for a first predetermined time period comprises determining whether the elapsed time is greater than or equal to the first predetermined time period.

34. The device of claim 33, further comprising:

means for sensing intrinsic signals of the patient;

means for detecting a predetermined event in response to the sensed intrinsic signals; and

means for determining whether the predetermined event is detected subsequent to the onset of the first state being detected for the first predetermined time period.

35. The device of claim 26, further comprising

means for generating a first threshold and a second threshold corresponding to a transition of the patient between the first state and a second state in response to the minute ventilation values;

and

means for detecting onset of the first state in response to the second distribution rate being less than the first threshold and the second distribution rate being greater than or equal to the first distribution rate, and

means for detecting a transition between the first state and the second state in response to the second distribution rate being less than the first distribution rate and the first distribution rate being greater than the second threshold.

36. The device of claim 33, further comprising:

means for determining, in response to the first state not being sustained, whether a second predetermined time period has expired; and

means for reducing the first predetermined time period in response to the second predetermined time period being expired.

37. The device of claim 36, further comprising:

means for determining, in response to the first state being sustained and the elapsed time subsequently not being greater than or equal to the first predetermined time period, whether a predetermined delivery time has been reached and the second predetermined time period has expired;

means for sensing intrinsic signals of the patient;

means for detecting a predetermined event in response to the sensed intrinsic signals;

means for determining, in response to the predetermined delivery time being reached and the second predetermined time period having expired, whether the predetermined event is detected; and

means for delivering the therapy in response to the predetermined event being detected.

38. A computer readable medium having computer executable instructions for performing a method comprising:

sensing a physiologic parameter corresponding to minute ventilation values indicative of a minute ventilation of the patient;

detecting onset of a first state of the patient in response to the sensed parameter, wherein the first state corresponds to an asleep state; and

determining whether the onset of the first state is detected for a first predetermined time period,

wherein detecting the onset of the first state comprises;

determining a plurality of the minute ventilation values at predetermined time intervals over a period of time;

generating a first distribution rate of minute ventilation values of the plurality of minute ventilation values received during first time intervals m of the predetermined time intervals, including a current time interval and first preceding time intervals m1, and a second distribution rate of minute ventilation values received during second time intervals n of the predetermined time intervals, including the current time interval and second preceding time intervals n1, and

detecting the onset of the first state in response to the second distribution rate being greater than the first distribution rate.

39. A computer readable medium having computer executable instructions for performing a method comprising:

sensing minute ventilation values indicative of a minute ventilation of the patient;

generating a first threshold and a second threshold corresponding to a physiologic transition of the patient between a first state and a second state in response to the minute ventilation values;

generating a first distribution rate of a plurality of the sensed minute ventilation values received during first time intervals of predetermined time intervals including a first current time interval m and first preceding time intervals m 1 and a second distribution rate of a plurality of the sensed minute ventilation values received during second time intervals of the predetermined time intervals including a second time interval n and second preceding time intervals n1;

detecting onset of the second state in response to the second distribution rate being less than the first threshold, an abrupt transition between the first state and the second state, and the second distribution rate being greater than or equal to the first distribution rate; and

modifying the therapy in response to the detected onset of the second state.