Materials and methods for diagnosis
US-2024103020-A1 · Mar 28, 2024 · US
US9420959B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-9420959-B2 |
| Application number | US-201113324142-A |
| Country | US |
| Kind code | B2 |
| Filing date | Dec 13, 2011 |
| Priority date | Dec 15, 2010 |
| Publication date | Aug 23, 2016 |
| Grant date | Aug 23, 2016 |
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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.
Opening claim text (preview).
The claimed invention is: 1. A system for monitoring a worsening heart failure condition, 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, at least one of the first, second, and third states correspond to a thoracic fluid status of the subject or a respiration status of the subject, and at least one of the first, second, and third states correspond to a non-fluid related status or non-respiration related status of the subject; a first forward state transition from the first state to the second state in response to a first transition trigger; 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 prior to expiration of the first timer; a second forward state transition from the second to the third state in response to a second transition trigger; 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 prior to expiration of the first timer. 2. The system of claim 1 , wherein the first reverse state transition is in response to the expiration of a third timer, wherein the third timer corresponds with a maximum time to complete the state sequence. 3. The system of claim 2 , further comprising a third reverse state transition, wherein the third reverse state transition is in response to the expiration of the third timer. 4. The system of claim 3 , wherein the state machine circuit further comprises: the state sequence, wherein the state sequence further comprises a fourth state; a third forward state transition between the first and fourth states in response to a third transition trigger; a fourth reverse state transition between the fourth and first states in response to at least one of expiration of a fourth timer or ceasing of the third transition trigger, wherein the fourth timer is capable of being set to a different time limit value than the first, second and third timer values; a fourth forward state transition between the fourth and second states in response to a fourth transition trigger; and a fifth reverse state transition between the second and fourth states in response to at least one of expiration of a fifth timer or ceasing of the third transition trigger, wherein the fifth timer is capable of being set to a different time limit value than the first, second, third and fourth timer values. 5. 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. 6. The system of claim 5 , wherein the plurality of physiologic sensors includes at least one ambulatory sensor. 7. 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 triggering the first and second forward state transition. 8. The system of claim 1 , wherein the first state comprises a baseline condition of a subject, wherein the baseline condition is associated with the first and second physiological characteristics. 9. The system of claim 1 , wherein the system further comprises 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. 10. The system of claim 9 , wherein the specified response includes at least one of an alert and a report. 11. The system of claim 9 , wherein the third state corresponds to a clinical event of a subject. 12. The system of claim 11 , wherein the third state further corresponds to a worsening heart failure event of the subject. 13. The system of claim 1 , wherein the first and second timers are capable of being set with a variable time limit value, wherein the variable time limit value corresponds with at least one of the first and second physiological characteristics. 14. The system of claim 1 , wherein the second timer is capable of being set to a different time limit value from the first timer. 15. A method of monitoring a worsening heart failure condition using a medical device, comprising: receiving information about different first and second physiological characteristics of a subject; transitioning from a first state to a second state in a first forward state transition in response to a first transition trigger, wherein a state represents a physiological status of the subject, at least one of the first state, the second state, and a third state corresponds to a thoracic fluid status of the subject or a respiration status of the subject, and at least one of the first, second, and third states corresponds to a non-fluid related status or non-respiration related status of the subject; transitioning from the second state to the first state in a first reverse transition in response to first of expiration of a first timer and ceasing of the first transition trigger prior to expiration of the first timer; transitioning from the second state to the third state in a second forward state transition in response to a second transition trigger; and transitioning from the third state to the second state in a second reverse transition in response to first of expiration of a second timer and ceasing of the second transition trigger prior to expiration of the first timer. 16. The method of claim 15 , 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. 17. The method of claim 15 , wherein the physiological sensors include at least one ambulatory sensor. 18. The method of claim 15 , wherein transitioning from the second state to the first state further includes a response to the expiration of a third timer, wherein the third timer corresponds with a maximum time to complete the state sequence. 19. The method of claim 15 , comprising transitioning from the third state to the first state in response to the expiration of the third timer. 20. The method of claim 15 , 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 state to the second state or transitioning from the second state to the third state. 21. The method of claim 15 , wherein the first state comprises a baseline condition of a subject, wherein the baseline condition is associated with the first and second physiological characteristics. 22. The method of claim 15 , wherein the method further comprises communicating a specified response after transitioning from the second state to the third state. 23. The method of claim 22 , wherein the specified response includes an alert. 24. The method of claim 22 , wherein the specified response includes a report. 25. The method of claim 22 , wherein the third state corresponds to a clinical ev
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