Characterization of sleep disorders using composite patient data

• US 20070055115A1
• Filed: 09/08/2005
• Published: 03/08/2007
• Est. Priority Date: 09/08/2005
• Status: Abandoned Application

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kwok, Jonathan, Lee, Kent
• Application Number:
  US11/222,384
• Publication Number:
  US 20070055115A1
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/4806 Sleep evaluation A61B5/4821 takes precedence; devices for inducing sleep A61M21/02
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

Systems and methods provide for evaluating sleep disorders, and involve implantably detecting one or more conditions associated with a sleep disorder, and receiving manually-reported patient data having relevance to the sleep disorder or patient condition. Using the detected conditions and the patient data, a quantitative diagnostic value for the sleep disorder is produced. The diagnostic value may be indicative of presence or non-presence of the sleep disorder or indicative of a level of severity of the sleep disorder. The manually-reported patient data may be acquired by use of a questionnaire or other patient question/answer facility.

Claims

1. A method, comprising:

implantably sensing one or more conditions associated with a sleep disorder;

computing a detection value based on the sensed one or more conditions;

receiving manually-reported patient data having relevance to the sleep disorder or patient condition;

computing a patient data score using the received patient data; and

producing a diagnostic value for the sleep disorder using the detection value and patient data score.

2. The method of claim 1, wherein the diagnostic value is indicative of presence or non-presence of the sleep disorder.

3. The method of claim 1, wherein the diagnostic value is indicative of a level of severity of the sleep disorder.

4. The method of claim 1, wherein the diagnostic value is a Boolean value.

5. The method of claim 1, wherein the diagnostic value is a numerical value.

6. The method of claim 1, wherein producing the diagnostic value comprises logically combining the detection value and the patient data score to produce the diagnostic value.

7. The method of claim 1, wherein producing the diagnostic value comprises mathematically combining the detection value and the patient data score to produce the diagnostic value.

8. The method of claim 1, wherein receiving the patient data comprises receiving the patient data in the form of a questionnaire, the questionnaire comprising a plurality of questions each of which is assigned a value, and computing the patient data score comprises operating on the values to compute the patient data score.

9. The method of claim 1, wherein computing the detection value comprises summing a number of the one or more conditions sensed over a predefined duration of time.

10. The method of claim 1, wherein:

sensing the one or more conditions further comprises detecting apnea or hypopnea events over a predefined duration of time; and

computing the detection values comprises computing an apnea/hypopnea index (AHI) based on a number of the apnea or hypopnea events detected over the predefined duration of time.

11. The method of claim 1, further comprising:

receiving one or more patient condition indicators; and

producing one or more patient condition values corresponding to the one or more patient condition indicators;

wherein the diagnostic value is produced using the detection value, patient data score, and the one or more patient condition values.

12. The method of claim 1, further comprising providing a first threshold associated with detection of the one or more conditions associated with the sleep disorder, and providing a second threshold associated with the patient data, wherein:

the detection value is computed using the sensed one or more conditions that exceed the first threshold; and

the patient data score is computed using the received patient data that exceeds the second threshold.

13. The method of claim 1, further displaying one or more of the diagnostic value, patient data score, and detection data.

14. The method of claim 1, further comprising:

producing trend data using a plurality of the detection values computed over time; and

producing alert information when the trend data exceeds one or more thresholds indicative of presence of the sleep disorder.

15. A method for evaluating sleep disorders, comprising:

implantably detecting one or more conditions associated with a sleep disorder;

receiving manually-reported patient data having relevance to the sleep disorder or patient condition; and

producing a quantitative diagnostic value for the sleep disorder using the detected conditions and the patient data.

16. The method of claim 15, wherein producing the diagnostic value is performed by a networked system.

17. The method of claim 15, wherein receiving the patient data comprises receiving the patient data via a programmer or a patient management system interface.

18. The method of claim 15, wherein the diagnostic value comprises a Boolean value developed from a Boolean operation performed on the patient data and data indicative of the sensed one or more conditions associated with the sleep disorder.

19. An apparatus, comprising:

a body implantable sensing device configured to sense one or more conditions associated with a sleep disorder;

a user interface device configured to receive manually-reported patient data having relevance to the sleep disorder or patient condition; and

a processing system configured to compute a detection value based on the sensed one or more conditions, compute a patient data score using the received patient data, and produce a diagnostic value for the sleep disorder using the detection value and patient data score.

20. The apparatus of claim 19, wherein the body implantable sensing device comprises an implantable cardiac monitoring device or an implantable cardiac energy delivery device.

21. The apparatus of claim 19, wherein the body implantable sensing device comprises a sleep disordered breathing sensor, and the detection value computed by the processing system comprises an apnea/hypopnea index.

22. The apparatus of claim 19, wherein the user interface device comprises a programmer configured to communicatively couple to the body implantable sensing device.

23. The apparatus of claim 19, wherein the user interface device comprises a network interface configured to communicatively couple to a patent management network system.