Apparatus and method for monitoring for disordered breathing

• US 7,438,686 B2
• Filed: 04/21/2003
• Issued: 10/21/2008
• Est. Priority Date: 01/10/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sowelam, Sameh, Cho, Yong K, Lawabni, Abed E., Sheldon, Todd J, Markowitz, H T, Pitschneider, Raylene
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US10/419,404
• Publication Number:
  US 20050119711A1
• Time in Patent Office: 2,010 Days
• Field of Search: 607/42, 607/17, 607 19- 20, 607 24- 25, 600/529, 600483-484
• US Class Current: 600/484
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/4818 Sleep apnoea

Abstract

The present invention relates to a device and method for monitoring for sleep disordered breathing or other types of disordered breathing such as Cheyne-Stokes breathing. More specifically, a device and method for detecting disordered breathing is provided that monitors a physiological parameter, which becomes cyclical due to apnea-hyperpnea (or arousal) alternation and provides the basis for the determination of a number of breathing disorder metrics.

Claims

1. A method of detecting disordered breathing in an implantable medical device in a patient, comprising:

monitoring a physiologic characteristic of a patient that is a direct indicator of heart rate with at least one implantable sensor that provides an output signal indicative of the heart rate;

identifying a cyclical variation of the heart rate, the cyclical variation comprising a first period corresponding to a first heart rate alternating with a second period corresponding to a second heart rate greater than the first heart rate;

comparing said cyclical variation to threshold criteria indicative of a sleep disordered breathing event; and

declaring the presence of the disordered breathing episode in the event that there is a positive correlation between the comparison of the cyclical variation and the threshold.

2. A method according to claim 1, wherein the at least one sensor is an electrogram circuit and said electrogram circuit further comprises at least a pair of electrodes electrically coupled to the implantable medical device.

3. A method according to claim 2, further comprising an impedance sensor coupled to a sensing circuit of the implantable medical device.

4. A method according to claim 1, wherein the at least one sensor is an impedance sensor.

5. A method according to claim 1, wherein said at least one sensor is a QT interval measurement means.

6. A method according to claim 5, further comprising withholding a declaration of the presence of the disordered breathing event until a preset number of cardiac cycles have occurred.

7. A method according to claim 1, wherein a predetermined sensing period is defined and the aggregate number of declared disordered breathing events is divided by the sensing period so that an index value is calculated for said sensing period.

8. A method according to claim 1, further comprising providing an anti-disordered breathing electrical stimulation therapy to a portion of tissue of said patient.

9. The method of claim 1 wherein identifying a cyclical variation of the heart rate comprises:

determining a mean heart rate;

setting an upper rate threshold and a lower rate threshold in response to the determined mean heart rate;

detecting a first crossing of the lower rate threshold;

detecting a first crossing in an upper direction of the upper rate threshold subsequent to the first crossing of the lower rate threshold;

detecting a second crossing in a downward direction of the upper rate threshold subsequent to the first upper rate threshold crossing;

detecting a second crossing of the lower rate threshold subsequent to the second upper rate threshold crossing; and

identifying the cyclical variation in heart rate in response to the detected second crossing.

10. The method of claim 9 wherein detecting the cyclical variation in heart rate further comprises:

setting a cycle onset time in response to the first crossing of the lower rate threshold,

setting a cycle end time in response to the second crossing of the lower rate threshold; and

comparing the difference between the cycle onset time and cycle end time to a disordered breathing cycle length threshold.

11. The method of claim 10 further comprising:

detecting if more than two consecutive crossings of one of the upper and lower rate thresholds occurs without an intervening crossing of the other of the upper and lower rate threshold;

detecting an invalid cyclical variation in heart rate for detecting disordered breathing in response to detecting the more than two consecutive crossings.

12. An implantable device for detecting, and optionally, providing a therapy for disordered breathing, comprising:

means for sensing a physiologic parameter that is a direct indicator of heart rate with an implantable sensor;

means for detecting a cyclical variation in the sensed physiologic parameter of a patient, wherein said cyclical variation of the heart rate occurs during an episode of disordered breathing, the cyclical variation comprising a first period corresponding to a first heart rate alternating with a second period corresponding to a second heart rate greater than the first heart rate;

means for comparing said cyclical variation to a threshold criteria; and

means for setting a disordered-breathing-detected marker in the event that said cyclical variation exceeds the threshold criteria.

13. A device according to claim 12, wherein said means for detecting includes means for providing QT interval monitoring.

14. A device according to claim 12, wherein said means for detecting further comprise an EGM circuit coupled to at least one electrode.

15. A device according to claim 12, further comprising means for providing an electrical stimulation therapy intended to abate the disordered breathing episode.

16. A device according to claim 15, further comprising means for storing data related to each of a plurality of detected episodes of disordered breathing.

17. A device according to claim 16, further comprising means for calculating a disordered breathing index based at least in part upon the stored data.

18. A device according to claim 12, wherein said means for detecting comprises at least two physiologic sensors and further comprising means for comparing an output signal set from said sensors to confirm or deny the presence of an episode of disordered breathing and/or for switching from a one of said at least two physiologic sensor to another of said at least two physiologic sensors.