Systems and methods for detecting worsening heart failure

• US 10,660,577 B2
• Filed: 03/30/2017
• Issued: 05/26/2020
• Est. Priority Date: 04/01/2016
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Thakur, Pramodsingh Hirasingh, Zhang, Yi, An, Qi, Averina, Viktoria A.
• Primary Examiner(s): Dougherty, Sean P
• Assistant Examiner(s): Melhus, Benjamin S
• Application Number:
  US15/473,783
• Publication Number:
  US 20170281097A1
• Time in Patent Office: 1,153 Days
• 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 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/091 Measuring volume of inspired or expired gases, e.g. to determine lung capacity
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• 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 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• 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: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• 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 1/36585 controlled by two or more physical parameters
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

Systems and methods for detecting worsening cardiac conditions such as worsening heart failure events are described. A system may include sensor circuits to sense physiological signals and signal processors to generate from the physiological signals first and second signal metrics. The system may include a risk stratifier circuit to produce a cardiac risk indication. The system may use at least the first signal metric to generate a primary detection indication, and use at least the second signal metric and the risk indication to generate a secondary detection indication. The risk indication may be used to modulate the second signal metric. A detector circuit may detect the worsening cardiac event using the primary and secondary detection indications.

Claims

1. A system comprising:

a signal processor circuit configured to;

receive a first physiological signal;

generate a first signal metric from the first physiological signal;

receive a second physiological signal different from the first physiologic signal; and

generate a second signal metric, different from the first signal metric, from the second physiological signal;

a detector circuit configured to;

receive a risk indication indicating a cardiac risk of the patient;

generate a primary detection indication of a presence or absence of a worsening cardiac event based on the first signal metric;

generate a secondary detection indication of a presence or absence of the worsening cardiac event, different from the primary detection indication, based on the second signal metric;

modulate the secondary detection indication by the risk indication; and

detect the worsening cardiac event as a combination of (1) the unmodulated primary detection indication and (2) the modulated secondary detection indication; and

an output circuit configured to generate an alert in response to the detection of the worsening cardiac event.

2. The system of claim 1, further comprising a therapy circuit configured to deliver a therapy in response to the detection of the worsening cardiac event.

3. The system of claim 1, wherein the first signal metric includes a heart sound signal metric and the second signal metric includes a respiratory signal metric, wherein the heart sound signal metric includes a third heart sound (S3) intensity or a ratio of a third heart sound (S3) intensity to a reference heart sound intensity;

and

wherein the respiratory signal metric includes a respiration rate measurement, a tidal volume measurement, or a ratio of the respiration rate to the tidal volume measurement.

4. The system of claim 1, wherein the detector circuit is configured to detect the worsening cardiac event using a decision tree including the primary detection indication and the modulated secondary detection indication,

wherein the detector circuit is configured to modulate the secondary detection indication using a sub-decision tree included in the decision tree, the sub-decision tree including the risk indication and the secondary detection indication.

5. The system of claim 4, wherein the signal processor circuit is configured to receive a third physiological signal different from the first and second physiological signals, and

wherein the detector circuit is configured to:

generate a third detection indication using the third physiological signal and the sub-decision tree;

and

if the modulated secondary detection indication indicates no detection of the worsening cardiac event, detect the worsening cardiac event based on a combination of the primary detection indication and the third detection indication.

6. The system of claim 1, wherein:

at least one of the primary or secondary detection indication includes a Boolean-logic or fuzzy-logic combination of two or more signal metrics;

or

the risk indication includes a Boolean-logic or fuzzy-logic combination of two or more risk indications.

7. The system of claim 1, wherein the detector circuit is configured to:

modulate the second signal metric by the risk indication;

generate a composite signal trend using a combination of the first signal metric and the modulated second signal metric; and

detect the worsening cardiac event in response to the composite signal trend satisfying a specified condition.

8. The system of claim 7, wherein the composite signal trend includes a linear combination of a temporal change of the first signal metric and a temporal change of the modulated second signal metric, the modulated second signal metric including:

the temporal change of the second signal metric weighted by the risk indication;

or

the temporal change of the second signal metric sampled when the risk indication satisfies a specified condition.

9. The system of claim 1, wherein the risk indication includes a composite cardiac risk indication, the system comprising:

a risk stratifier circuit configured to;

generate a primary cardiac risk indication using at least the first signal metric;

generate a secondary cardiac risk indication using at least the second signal metric; and

generate the composite cardiac risk indication using at least one of the primary cardiac risk indication or the secondary cardiac risk indication.

10. The system of claim 9, wherein:

the signal processor circuit is configured to receive a third physiological signal different from the first and second physiological signals, and to generate a third signal metric from the third physiological signal; and

the risk stratifier circuit is to generate a secondary cardiac risk indication using a plurality of measurements of the second signal metric during a time period when the third signal metric satisfies a specified condition.

11. The system of claim 9, wherein:

the signal processor circuit is to generate a first plurality of measurements of the first signal metric and a second plurality of measurements of the second signal metric; and

the risk stratifier circuit is to;

generate the primary cardiac risk indication including a first statistic of the first plurality of measurements of the first signal metric, and the secondary cardiac risk indication including a second statistic of the second plurality of measurements of the second signal metric; and

generate the composite cardiac risk indication using a combination of the first statistic of the first signal metric and the second statistic of the second signal metric.

12. The system of claim 9, further comprising a fusion model selector circuit configured to select a fusion model from a plurality of candidate fusion models based on signal quality of the first and second physiological signals,

wherein the risk stratifier circuit is configured to generate the composite cardiac risk indication using both the primary and secondary cardiac risk indications according to the selected fusion model.

13. A method comprising:

receiving, via a signal processor circuit, first and second physiological signals;

generating, via the signal processor circuit, a first signal metric from the first physiological signal and a second signal metric from the second physiological signal;

receiving, via a detector circuit, a risk indication indicating a cardiac risk of the patient;

generating, via the detector circuit, a primary detection indication of a presence or absence of a worsening cardiac event based on the first signal metric, and a secondary detection indication of a presence or absence of the worsening cardiac event based on the second signal metric;

modulating, via the detector circuit, the secondary detection indication by the risk indication; and

detecting, via the detector circuit, the worsening cardiac event as a combination of (1) the unmodulated primary detection indication, and (2) the modulated secondary detection indication.

14. The method of claim 13, wherein detecting the worsening cardiac event includes using a decision tree including the primary detection indication and the modulated secondary detection indication,

wherein modulating the secondary detection indication includes using a sub-decision tree of the decision tree, the sub-decision tree including the risk indication and the secondary detection indication.

15. The method of claim 14, wherein:

at least one of the primary or secondary detection indication includes a Boolean-logic or fuzzy-logic combination of two or more signal metrics;

or

the risk indication includes a Boolean-logic or fuzzy-logic combination of two or more risk indications.

16. The method of claim 14, further comprising:

modulating the second signal metric by the risk indication;

generating a composite signal trend using a combination of the first signal metric and the modulated second signal metric; and

detecting the worsening cardiac event in response to the composite signal trend satisfying a specified condition.

17. The method of claim 16, wherein modulating the second signal metric includes weighting a temporal change of the second signal metric by the risk indication, or sampling a temporal change of the second signal metric when the risk indication satisfies a specified condition.

18. The method of claim 13, wherein the risk indication includes a composite cardiac risk indication, the method comprising:

generating a primary cardiac risk indication using at least a first signal metric for cardiac risk assessment;

generating a secondary cardiac risk indication using at least a second signal metric for cardiac risk assessment; and

generating a composite cardiac risk indication using both the primary and secondary cardiac risk indications.

19. The method of claim 18, comprising receiving a third physiological signal different from the first and second physiological signals, and generating a third signal metric from the third physiological signal, wherein generating the secondary cardiac risk indication includes taking a plurality of measurements of the second signal metric during a time period when the third signal metric satisfies a specified condition.

20. A system comprising:

a signal processor circuit configured to;

receive first physiological information;

generate a first signal metric from the first physiological information;

receive second physiological information different from the first physiologic information; and

generate a second signal metric, different from the first signal metric, from the second physiological information;

a detector circuit configured to;

receive a risk indication indicating a cardiac risk of the patient;

generate a first detection indication of a presence or absence of a worsening cardiac event based on the first signal metric;

generate a second detection indication of a presence or absence of a worsening cardiac event, different from the first detection indication; and

detect the worsening cardiac event as a combination of the first detection indication, irrespective of the risk indication, and a combination of the second signal metric and the risk indication; and

an output circuit configured to generate an alert in response to the detection of the worsening cardiac event.