IP Library Granted Patent US 12,488,900
Granted Patent B2
US 12,488,900 · App. 18/206,752 · Granted Dec 2, 2025

Systems and methods for transitioning patient care from signal-based monitoring to risk-based monitoring

Inventors: Dimitar V. Baronov (Weston, MA); Evan J. Butler (New Haven, CT); Jesse M. Lock (Winchester, MA); Michael F. McManus (Pembroke, MA)
Assignee: Etiometry Inc.
G16H50/30G16H50/20G16H50/50
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Quick Facts
Patent No.
US 12,488,900
App. No.
18/206,752
Granted
Dec 2, 2025
Kind
B2
Abstract

A risk-based patient monitoring system for critical care patients combines data from multiple sources to assess the current and the future risks to the patient, thereby enabling providers to review a current patient risk profile and to continuously track a clinical trajectory. A physiology observer module in the system utilizes multiple measurements to estimate Probability Density Functions (PDF) of a number of Internal State Variables (ISVs) that describe components of the physiology relevant to the patient treatment and condition. A clinical trajectory interpreter module in the system utilizes the estimated PDFs of ISVs to identify under which probable patient states the patient can be currently categorized and assign a probability value that the patient will be in each of the identified states. The combination of patient states and their probabilities is defined as the clinical risk to the patient.

Claims (85)

1 . A computer-based method of risk-based monitoring of a patient, the method comprising:

generating, by the computer, predicted probability density functions of internal state variables for a subsequent time step (t k+1 ), wherein the predicted probability density functions are calculated using posterior estimated probability density functions from a preceding time step (t k );

acquiring, by the computer at subsequent time step (t k+1 ), physiological data from a set of sensors connected with the patient;

generating a conditional likelihood kernel for the subsequent time step (t k+1 ), the conditional likelihood kernel comprising conditional probability density functions of the physiological data acquired at subsequent time step (t k+1 ) given the predicted probability density functions of internal state variables for subsequent time step (t k+1 );

continuously estimating a risk that a particular bio-marker of the patient is abnormal, wherein the particular bio-marker comprises a hidden internal state variable, because it exceeds, by being either above or below, a corresponding pre-defined clinically significant value for that bio-marker, by:

generating, using Bayes theorem operating on (a) the conditional likelihood kernel and (b) predicted probability density functions of internal state variables for subsequent time step (t k+1 ), posterior probability density functions for the plurality of the internal state variables for the subsequent time step (t k+1 ); and

generating, for the particular bio-marker and based on the posterior probability density functions for the subsequent time step (t k+1 ), a probability that the particular bio-marker exceeds the corresponding pre-defined threshold for that particular bio-marker; and

generating, for display on a display device, a graphical depiction of the risk that the bio-marker is abnormal.

2 . The method of claim 1 , wherein the hidden internal state variable is not measured directly.

3 . The method of claim 1 wherein:

the set of sensors includes (i) a heart rate sensor, and (ii) a pulse oximetry sensor;

the physiological data comprises heart rate from the heart rate sensor, and oxygen level from the pulse oximetry sensor;

the particular bio-marker comprises mixed venous oxygen saturation; and

the corresponding threshold is mixed venous oxygen saturation at or below a level indicating a patient state of inadequate oxygen delivery.

4 . The method of claim 1 wherein:

the set of sensors includes (i) a heart rate sensor, and (ii) a pulse oximetry sensor, and (iii) a respiratory rate sensor;

the physiological data comprises heart rate from the heart rate sensor, oxygen level from the pulse oximetry sensor, and respiratory rate from the respiratory rate sensor;

the particular bio-marker comprises arterial partial pressure of carbon dioxide blood; and

the corresponding threshold is arterial partial pressure of carbon dioxide at or above a level indicating a patient state of inadequate ventilation of carbon dioxide.

5 . The method of claim 1 wherein:

the set of sensors includes (i) a heart rate sensor, and (ii) a pulse oximetry sensor, and (iii) a respiratory rate sensor;

the physiological data comprises heart rate from the heart rate sensor, oxygen level from the pulse oximetry sensor, and respiratory rate from the respiratory rate sensor;

the particular bio-marker comprises blood pH; and

the corresponding threshold is a blood pH below a level indicating a patient state of acidosis.

6 . The method of claim 1 wherein:

the set of sensors includes (i) a heart rate sensor, and (ii) a pulse oximetry sensor;

the physiological data comprises heart rate from the heart rate sensor, and oxygen level from the pulse oximetry sensor;

the particular bio-marker comprises arterial lactate level; and

the corresponding threshold is an arterial lactate blood level greater than a level indicating a patient state of hyperlactatemia.

7 . A system for risk-based monitoring of a patient, the system comprising:

a data reception module configured to receive measurements of internal state variables from a set of sensors operably coupled to the patient;

an observation model configured to produce a conditional likelihood kernel comprising conditional probability density functions of the physiological data acquired at subsequent time step (t k+1 ) given the predicted probability density functions of internal state variables for subsequent time step (t k+1 ), the predicted probability density functions calculated using posterior estimated probability density functions from a preceding time step (t k );

an inference engine configured to generate, using Bayes theorem operating on (a) the conditional likelihood kernel and (b) predicted probability density functions of internal state variables for subsequent time step (t k+1 ), posterior probability density functions for the plurality of the internal state variables for the subsequent time step (t k+1 );

a clinical trajectory interpreter module configured to generate, for a particular bio-marker that is a hidden internal state variable, and based on the posterior probability density functions for the subsequent time step (t k+1 ), a probability that the particular bio-marker is abnormal by exceeding a corresponding pre-defined threshold comprising a clinically significant value for that bio-marker, wherein said probability may exceed said threshold being either above or below said corresponding pre-defined clinically significant value for that bio-marker; and

a user interaction module configured to generate, for display on a display device, the risk that the bio-marker is abnormal.

8 . The system of claim 7 wherein:

the sensors include (i) a heart rate sensor, and (ii) a pulse oximetry sensor;

the physiological data comprises heart rate from the heart rate sensor, and oxygen level from the pulse oximetry sensor;

the particular bio-marker comprises mixed venous oxygen saturation, which is the hidden internal state variable; and

the corresponding threshold is mixed venous oxygen saturation at or below a given threshold, indicating a patient state of inadequate oxygen delivery.

9 . The system of claim 7 wherein:

the set of sensors includes (i) a heart rate sensor, and (ii) a pulse oximetry sensor, and (iii) a respiratory rate sensor;

the physiological data comprises heart rate from the heart rate sensor, oxygen level from the pulse oximetry sensor, and respiratory rate from the respiratory rate sensor;

the particular bio-marker comprises arterial partial pressure of carbon dioxide, which is the hidden internal state variable; and

the particular bio-marker comprises arterial partial pressure of carbon dioxide (PaCO2) at or above a level indicating a patient state of inadequate ventilation of carbon dioxide.

10 . The system of claim 7 wherein:

the set of sensors includes (i) a heart rate sensor, and (ii) a pulse oximetry sensor, and (iii) a respiratory rate sensor;

the physiological data comprises heart rate from the heart rate sensor, oxygen level from the pulse oximetry sensor, and respiratory rate from the respiratory rate sensor;

the particular bio-marker comprises blood pH, which is the hidden internal state variable; and

the corresponding threshold is a blood pH below a level indicating a patient state of acidosis.

11 . The system of claim 7 wherein:

the sensors include (i) a heart rate sensor, and (ii) a pulse oximetry sensor;

the physiological data comprises heart rate from the heart rate sensor, and oxygen level from the pulse oximetry sensor;

the particular bio-marker comprises arterial lactate level, which is the hidden internal state variable; and

the corresponding threshold is an arterial lactate blood level greater than a level indicating a patient state of hyperlactatemia.

12 . The system of claim 7 , wherein the hidden internal state variable is not measured directly.

13 . A non-transient computer program product comprising executable code, which executable code, when executed by a computer processor, causes the computer processor to implement a method of risk-based monitoring of a patient, the method comprising:

generating, by the computer, predicted probability density functions of internal state variables for a subsequent time step (t k+1 ), wherein the predicted probability density functions are calculated using posterior estimated probability density functions from a preceding time step (t k );

receiving, at the computer at subsequent time step (t k+1 ), physiological data from the set of sensors connected with the patient;

generating a conditional likelihood kernel for the subsequent time step (t k+1 ), the conditional likelihood kernel comprising conditional probability density functions of the physiological data acquired at subsequent time step (t k+1 ) given the predicted probability density functions of internal state variables for subsequent time step (t k+1 );

continuously estimating a risk that a particular bio-marker of the patient is abnormal by being either above or below a corresponding pre-defined clinically significant value for that bio-marker, indicating that the patient is suffering a specific adverse medical condition, by:

generating, using Bayes theorem operating on (a) the conditional likelihood kernel and (b) predicted probability density functions of internal state variables for subsequent time step (t k+1 ), posterior probability density functions for the plurality of the internal state variables for the subsequent time step (t k+1 ); and

generating, for the for a particular bio-marker internal state variable, which is a hidden internal state variable, and based on the posterior probability density functions for the subsequent time step (t k+1 ), a probability that the particular bio-marker internal state variable exceeds the corresponding pre-defined threshold for that particular internal state variable bio-marker; and

generating, for display, on a display device, a graphical depiction of the risk that the patient is suffering the specific adverse medical condition.

14 . The computer program product of claim 13 , wherein the particular bio-marker comprises a hidden internal state variable, which hidden internal state variable is not measured directly.

15 . The computer program product of claim 14 , wherein:

the set of sensors includes (i) a heart rate sensor, and (ii) a pulse oximetry sensor;

the physiological data comprises heart rate from the heart rate sensor and oxygen level from the pulse oximetry sensor;

the particular bio-marker comprises mixed venous oxygen saturation; and

the corresponding threshold is mixed venous oxygen saturation at or below a level indicating a patient state of inadequate oxygen delivery.

16 . The computer program product of claim 14 , wherein:

the set of sensors includes (i) a heart rate sensor, and (ii) a pulse oximetry sensor and (iii) a respiratory rate sensor;

the physiological data comprises heart rate from the heart rate sensor, oxygen level from the pulse oximetry sensor, and respiratory rate from the respiratory rate sensor;

the particular bio-marker comprises arterial partial pressure of carbon dioxide blood; and

the corresponding threshold is arterial partial pressure of carbon dioxide at or above a level indicating a patient state of inadequate ventilation of carbon dioxide.

17 . The computer program product of claim 14 , wherein:

the set of sensor includes (i) a heart rate sensor, and (ii) a pulse oximetry sensor and (iii) a respiratory rate sensor;

the physiological data comprises heart rate from the heart rate sensor, oxygen level from the pulse oximetry sensor, and respiratory rate from the respiratory rate sensor;

the particular bio-marker comprises blood pH; and

the corresponding threshold is a blood pH below a level indicating a patient state of acidosis.

18 . The computer program product of claim 15 , wherein:

the set of sensor includes (i) a heart rate sensor, and (ii) a pulse oximetry sensor;

the physiological data comprises heart rate from the heart rate sensor and oxygen level from the pulse oximetry sensor;

the particular bio-marker comprises arterial lactate level; and

the corresponding threshold is an arterial lactate blood level greater than a level indicating a patient state of hyperlactatemia.

Assignments (3)
SECURITY INTEREST Recorded Aug 8, 2025
From: ETIOMETRY INC.
To: ESCALATE CAPITAL V, LP
Reel/Frame 071974/0584 →
CORRECTIVE ASSIGNMENT TO CORRECT THE CORRECT THE NAME OF ASSIGNEE FROM ETIOMETRY, INC, TO ETIOMETRY INC. PREVIOUSLY RECORDED AT REEL: 64931 FRAME: 682. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Sep 11, 2024
From: BARONOV, DIMITAR V.; BUTLER, EVAN J.; LOCK, JESSE M.; MCMANUS, MICHAEL F.
To: ETIOMETRY INC.
Reel/Frame 068940/0062 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 18, 2023
From: BARONOV, DIMITAR V.; BUTLER, EVAN J.; LOCK, JESSE M.; MCMANUS, MICHAEL F.
To: ETIOMETRY, INC.
Reel/Frame 064931/0682 →
Continuity (15)
Continuation 17033591 · Sep 25, 2020
Continuation In Part 16113486 · Aug 27, 2018
Continuation 14727696 · Jun 1, 2015
Continuation 13826441 · Mar 14, 2013
Continuation In Part 13689029 · Nov 29, 2012
Continuation In Part 13328411 · Dec 16, 2011
Provisional Application 62906518 · Sep 26, 2019
Provisional Application 61774274 · Mar 7, 2013
Provisional Application 61727820 · Nov 19, 2012
Provisional Application 61699492 · Sep 11, 2012
Provisional Application 61684241 · Aug 17, 2012
Provisional Application 61620144 · Apr 4, 2012
Provisional Application 61614846 · Mar 23, 2012
Provisional Application 61614861 · Mar 23, 2012
Related Publication 20230317296A1 · Oct 5, 2023
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