Detecting heart failure by monitoring the time sequence of physiological changes

• US 10,039,499 B2
• Filed: 07/21/2016
• Issued: 08/07/2018
• Est. Priority Date: 12/15/2010
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Zhang, Yi, Averina, Viktoria A., Patangay, Abhilash, Wariar, Ramesh, Peterson, Jon
• Primary Examiner(s): Lee, Erica
• Application Number:
  US15/216,167
• Publication Number:
  US 20160324480A1
• Time in Patent Office: 747 Days
• Field of Search: None
• CPC Class Codes: A61B 2562/06 Arrangements of multiple sensors of different types
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/4842 Monitoring progression or stage of a disease
• 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 5/7282 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 7/00 Instruments for auscultation
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R

Abstract

Systems and methods for detecting heart failure by monitoring the time-sequence of physiological changes of a subject using a state machine circuit configured to receive information about physiological characteristics of the subject is described. The current state transitions between a first and a second state in response to a first transition trigger. The current state transitions between the second and first states in response to at least one of the expiration of a first timer or ceasing of the first transition trigger. The current state transitions between the second and third states in response to a second transition trigger. The current state transitions between the third and second states in response to at least one of expiration of a second timer or ceasing of the second transition trigger.

Claims

1. A system to detect a condition of worsening heart failure, the system comprising:

a state machine circuit, configured to receive information about different first and second physiological characteristics of a subject, wherein the state machine comprises;

a state sequence of at least first, second, and third states, wherein a state represents a physiological status of the subject, and wherein the first state includes a status of post-S2 heart sound energy in a sensed electrical heart sound signal and the third state corresponds to a worsening heart failure event of the subject;

a first forward state transition from the first state to the second state in response to a first transition trigger, wherein the first transition trigger includes a change in the post-S2 heart sound energy;

a first reverse state transition from the second state to the first state in response to first of expiration of a first timer and ceasing of the first transition trigger;

a second forward state transition from the second to the third state in response to a second transition trigger associated with worsening heart failure status of the subject; and

a second reverse state transition from the third state to the second state in response to first of expiration of a second timer and ceasing of the second transition trigger, and generating an alert indicating worsening heart failure event of the subject otherwise.

2. The system of claim 1, further comprising a third reverse state transition from the third device state to the first device state, wherein the third reverse state transition is in response to expiration of a third timer.

3. The system of claim 1, further comprising a plurality of physiological sensors, wherein the physiological sensors produce respective physiological signals including information about the first and second physiological characteristics.

4. The system of claim 1, further comprising an ambulatory heart sound sensing circuit configured to generate the heart sound signal including the post-S2 heart sound information.

5. The system of claim 4, wherein the first device state comprises a baseline status of post-S2 heart sound energy.

6. The system of claim 1, wherein the first and second transition triggers further include a time sequence parameter, wherein the time sequence parameter corresponds to a minimum time prior to transitioning from the first device state to the second device state or transitioning from the second device state to the third device state.

7. The system of claim 1, including a response circuit coupled to the state machine circuit, wherein the response circuit is operable to provide a specified response following the second forward state transition to the third state.

8. The system of claim 7, wherein the response circuit is configured to generate the alert following the second forward state transition to the third state.

9. The system of claim 7, wherein the response circuit is configured to generate a report following the second forward state transition to the third state.

10. A method of controlling operation of a medical device, the method comprising:

receiving information about different first and second physiological characteristics of an subject;

forward transitioning from a first device state to a second device state in response to a first transition trigger, wherein a device state represents a physiological status of the subject, and wherein the first device state includes a status of post-S2 heart sound energy in a sensed electrical heart sound signal and the first transition trigger includes a change in the post-S2 heart sound signal energy;

transitioning back from the second state to the first state in response to first of expiration of a first timer and ceasing of the first transition trigger;

forward transitioning from the device second state to a third device state in response to a second transition trigger, wherein the third device state corresponds to a worsening heart failure event of the subject;

transitioning back from the third state to the second state in response to first of expiration of a second timer and ceasing of the second transition trigger, and generating an alert indicating worsening heart failure event of the subject otherwise.

11. The method of claim 10, further comprising receiving a plurality of physiological signals from respective physiological sensors, wherein the physiological signals include information about the first and second physiological characteristics.

12. The method of claim 10, receiving a heart sound signal from an ambulatory heart sound sensor.

13. The method of claim 10, comprising transitioning from the third device state to the first device state in response to expiration of a third timer.

14. The method of claim 10, wherein the first and second transition triggers further include a time sequence parameter, wherein the time sequence parameter corresponds to a minimum time prior to transitioning from the first device state to the second device state or transitioning from the second device state to the third device state.

15. The method of claim 10, wherein the first device state comprises a baseline status of post-S2 heart sound energy.

16. The method of claim 10, wherein the third device state corresponds to a clinical event of a subject.

17. The method of claim 16, further comprising communicating a specified response after transitioning from the second device state to the third device state.

18. The method of claim 17, wherein the specified response includes the alert and a report.