Within-patient algorithm to predict heart failure decompensation

• US 8,456,309 B2
• Filed: 07/02/2012
• Issued: 06/04/2013
• Est. Priority Date: 12/27/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Sachanandani, Haresh G., Peterson, Jon, Cazares, Shelley M., Sweeney, Robert J., Stalsberg, Kevin John
• Primary Examiner(s): HOFSASS, JEFFERY A
• Application Number:
  US13/539,802
• Publication Number:
  US 20120271183A1
• Time in Patent Office: 337 Days
• Field of Search: 340/573.1, 340/540, 600/481, 600/483, 600/484, 600/485, 600/508
• US Class Current: 340/573.1
• CPC Class Codes: A61B 2560/0242 adapted to measure environmental factors, e.g. temperature, pollution
• 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 5/02455 provided with high/low alarm devices
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

This document discusses, among other things, systems and methods for predicting heart failure decompensation using within-patient diagnostics. A method comprises detecting an alert status of each of one or more sensors; calculating an alert score by combining the detected alerts; and calculating a composite alert score, the composite alert score being indicative of a physiological condition and comprising a combination of two or more alert scores.

Claims

1. A patient device comprising:

an analysis module adapted to;

calculate a composite alert score indicative of a likelihood of an onset of a physiological condition, the composite alert score being a combination of multiple alert scores, at least one of the multiple alert scores being a combination of multiple alert statuses, and at least one of the multiple alert statuses being from one of a plurality of detectors and indicative of an occurrence of an event; and

compare the composite alert score to a threshold; and

a communication module adapted to provide an indication of the likelihood of the onset of the physiological condition using the comparison.

2. The patent device of claim 1, wherein the alert status includes a value that reflects a comparison between a parameter detected at a respective one of the plurality of detectors and a corresponding threshold for the parameter.

3. The patent device of claim 1, wherein the parameter includes sensed physiological data.

4. The patent device of claim 1, wherein at least one of the plurality of detectors includes an implantable medical device.

5. The patent device of claim 1, wherein the patient device includes an implantable medical device.

6. The patent device of claim 1, wherein the analysis module automatically determines the threshold based on an input parameter.

7. The patent device of claim 6, wherein the input parameter includes one or more of a time, a number of detectors, a patient characteristic, a clinician preference, or a previous threshold.

8. The patent device of claim 1, wherein the analysis module establishes the threshold using a constant false alarm rate technique.

9. A non-transitory machine-readable medium comprising instructions, which when executed on a machine, cause the machine to:

calculate a composite alert score indicative of a likelihood of an onset of a physiological condition, the composite alert score being a combination of multiple alert scores, at least one of the multiple alert scores being a combination of multiple alert statuses, and at least one of the multiple alert statuses being from one of a plurality of detectors and indicative of an occurrence of an event;

compare the composite alert score to a threshold; and

provide an indication of the likelihood of the onset of the physiological condition using the comparison.

10. The non-transitory machine-readable medium of claim 9, comprising instructions to receive at least one of the multiple alert scores from at least one of the plurality of detectors.

11. The non-transitory machine-readable medium of claim 9, wherein the alert status includes a value that reflects a comparison between a parameter detected at a respective one of the plurality of detectors and a corresponding threshold for the parameter.

12. The non-transitory machine-readable medium of claim 11, wherein the parameter includes sensed physiological data.

13. The non-transitory machine-readable medium of claim 9, comprising instructions to automatically determine the threshold based on an input parameter.

14. The non-transitory machine-readable medium of claim 13, wherein the input parameter includes one or more of a time, a number of detectors, a patient characteristic, a clinician preference, or a previous threshold.

15. The non-transitory machine-readable medium of claim 9, comprising instructions to establish the threshold using a constant false alarm rate technique.

16. A method comprising:

calculating, by a computational system, a composite alert score indicative of a likelihood of an onset of a physiological condition, the composite alert score being a combination of multiple alert scores, at least one of the multiple alert scores being a combination of multiple alert statuses, and at least one of the multiple alert statuses being from one of a plurality of detectors and indicative of an occurrence of an event;

comparing the composite alert score to a threshold; and

providing an indication of the likelihood of the onset of the physiological condition using the comparison.

17. The method of claim 16, comprising receiving at least one of the multiple alert scores from at least one of the plurality of detectors.

18. The method of claim 16, wherein the alert status includes a value that reflects a comparison between a physiological parameter detected at a respective one of the plurality of detectors and a corresponding threshold for the physiological parameter.

19. The method of claim 16, automatically determining the threshold based on an input parameter, wherein the input parameter includes one or more of a time, a number of detectors, a patient characteristic, a clinician preference, or a previous threshold.

20. The method of claim 16, comprising establishing the threshold using a constant false alarm rate technique.

21. An apparatus comprising:

means for calculating a composite alert score indicative of a likelihood of an onset of a physiological condition, the composite alert score being a combination of multiple alert scores, at least one of the multiple alert scores being a combination of multiple alert statuses, and at least one of the multiple alert statuses being from one of a plurality of detectors and indicative of an occurrence of an event;

means for comparing the composite alert score to a threshold; and

means for providing an indication of the likelihood of the onset of the physiological condition using the comparison.