Within-patient algorithm to predict heart failure decompensation

• US 8,223,023 B2
• Filed: 09/09/2011
• Issued: 07/17/2012
• 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:
  US13/229,110
• Publication Number:
  US 20110319726A1
• Time in Patent Office: 312 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 method comprising:

calculating, by a computational system, a first and second alert score by combining alert statuses of a plurality of detectors, the alert statuses being indicative of a first event occurring in a first timeframe;

calculating, by the computational system, a composite alert score as a combination of the first and second alert scores, the composite alert score being indicative of a likelihood of an onset of a physiological condition;

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

providing an indication of the likelihood of the onset of the physiological condition in a patient when the composite alert score violates the composite alert score threshold.

2. The method of claim 1, further comprising detecting the alert statuses using the plurality of detectors.

3. The method of claim 2, wherein detecting the alert statuses of the plurality of detectors comprises:

detecting a parameter of a sensor coupled to at least one detector of the plurality of detectors;

comparing the parameter to a threshold value to obtain a comparison; and

using the comparison to detect the alert statuses.

4. The method of claim 3, wherein the parameter comprises sensed physiological data.

5. The method of claim 4, wherein the sensed physiological data comprises cardiac indications.

6. The method of claim 3, wherein the sensor comprises an implantable medical device.

7. The method of claim 3, wherein calculating the composite alert score comprises combining the first and second alert scores using a weighted function, and wherein a weight used in the weighted function is related to the sensor.

8. The method of claim 1, wherein the computational system comprises an implantable medical device.

9. The method of claim 1, wherein calculating the composite alert score comprises combining the first and second alert scores using a weighted function, and wherein a weight used in the weighted function is adapted based on a characteristic of the patient.

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

calculate a first and second alert score by combining alert statuses of a plurality of detectors, the alert statuses being indicative of a first event occurring in a first timeframe;

calculate a composite alert score as a combination of the first and second alert scores, the composite alert score being indicative of a likelihood of an onset of a physiological condition;

compare the composite alert score to a composite alert score threshold; and

provide an indication of the likelihood of the onset of the physiological condition in a patient when the composite alert score violates the composite alert score threshold.

11. The non-transitory machine-readable medium of claim 10, further comprising instructions to detect the alert statuses using the plurality of detectors.

12. The non-transitory machine-readable medium of claim 11, wherein the instructions to detect the alert statuses of the plurality of detectors comprise instructions to:

detect a parameter of a sensor coupled to at least one detector of the plurality of detectors;

compare the parameter to a threshold value to obtain a comparison; and

use the comparison to detect the alert statuses.

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

14. The non-transitory machine-readable medium of claim 13, wherein the sensed physiological data comprises cardiac indications.

15. The non-transitory machine-readable medium of claim 12, wherein the sensor comprises an implantable medical device.

16. The non-transitory machine-readable medium of claim 12, wherein the instructions to calculate the composite alert score comprise instructions to combine the first and second alert scores using a weighted function, and wherein a weight used in the weighted function is related to the sensor.

17. The non-transitory machine-readable medium of claim 10, wherein the machine comprises an implantable medical device.

18. The non-transitory machine-readable medium of claim 10, wherein the instructions to calculate the composite alert score comprise instructions to combine the first and second alert scores using a weighted function, and wherein a weight used in the weighted function is adapted based on a characteristic of the patient.

19. A patient device comprising:

an analysis module adapted to;

calculate a first and second alert score by combining alert statuses of a plurality of detectors, the alert statuses being indicative of a first event occurring in a first timeframe;

calculate a composite alert score as a combination of the first and second alert scores, the composite alert score being indicative of a likelihood of an onset of a physiological condition; and

compare the composite alert score to a composite alert score threshold; and

a communication module adapted to provide an indication of the likelihood of the onset of the physiological condition in a patient when the composite alert score violates the composite alert score threshold.

20. An apparatus comprising:

means for calculating a first and second alert score by combining alert statuses of a plurality of detectors, the alert statuses being indicative of a first event occurring in a first timeframe;

means for calculating a composite alert score, the composite alert score being indicative of a likelihood of an onset of a physiological condition and comprising a combination of two or more alert scores;

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

means for providing an indication of the likelihood of the onset of the physiological condition when the composite alert score violates the composite alert score threshold.