# US 11,382,571 B2 · Noninvasive predictive and/or estimative blood pressure monitoring

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- Number: US 11,382,571 B2
- Document ID: US11382571B2
- Status: Granted
- Kind: B2
- Application number: 14/535,171
- Filed: 2014-11-06
- Published: 2015-03-05
- Granted: 2022-07-12
- Earliest claimed: 2010-03-04
- Assignees: Flashback Technologies, Inc.; The Regents of the University of Colorado, a body corporate
- Applicants: Flashback Technologies, Inc.; The Regents of the University of Colorado, a body corporate
- Inventors: Isobel Jane Mulligan; Gregory Zlatko Grudic; Steven L. Moulton
- Web page: https://patentgrep.com/patent/US11382571B2

## CPC

- 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}
- A61B 5/02028: {Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction}
- A61B 5/02108: {from analysis of pulse wave characteristics}
- A61B 5/14551: {for measuring blood gases}
- A61B 5/329: Load diagnosis, e.g. cardiac stress tests
- A61B 5/384: Recording apparatus or displays specially adapted therefor
- A61B 5/7246: {using correlation, e.g. template matching or determination of similarity}
- A61B 5/7267: {involving training the classification device}
- A61B 7/04: Electric stethoscopes
- G16H 40/63: for local operation
- G16H 50/50: for simulation or modelling of medical disorders
- A61B 5/02042: {Determining blood loss or bleeding, e.g. during a surgical procedure}
- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/02241: {of small dimensions, e.g. adapted to fingers}
- A61B 5/029: Measuring blood output from the heart, e.g. minute volume
- A61B 5/4875: {Hydration status, fluid retention of the body}
- A61B 5/6826: {Finger}
- A61B 2562/0219: Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
- A61M 1/1613: {Profiling or modelling of patient or predicted treatment evolution or outcome}
- A61M 2230/30: Blood pressure (A61M2230/04 takes precedence)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

Tools and techniques for estimating and/or predicting a patient's current and/or future blood pressure. In some cases, the tools will analyze physiological data captured from the patient against a model of blood pressure values to estimate/predict the patient's blood pressure value. In particular cases, derived parameters, such as a patient's compensatory reserve index (“CRI”) can be analyzed against such models, while in other cases, data captured from sensors can be directly analyzed against such models.

## Claims

### Claim 1

A system, comprising:
one or more sensors to obtain physiological data from a patient, wherein the physiological data is cardiovascular data of the patient; and
a computer system in communication with the one or more sensors, the computer system comprising:
one or more processors; and
a computer readable medium in communication with the one or more processors, the computer readable medium having encoded thereon a set of instructions executable by the computer system to perform one or more operations, the set of instructions comprising:
instructions for receiving the physiological data from the one or more sensors;
instructions for estimating a blood pressure value of the patient,
wherein estimating the blood pressure value includes estimating a compensatory reserve index (“CRI”) value of the patient and estimating the blood pressure value from the estimated CRI value, wherein the CRI value of the patient is further used to estimate at least one of a dehydration state of the patient, a state of euvolemia of the patient, a state of hypervolemia of the patient, or a probability of bleeding of the patient,
wherein estimating the CRI value of the patient includes comparing the physiological data to a model, the model comprising a plurality of waveforms of reference data, each waveform of the plurality of waveforms corresponding to a respective CRI value determined using the following formula:
CRI
⁡
(
t
)
=
1
-
BLV
⁡
(
t
)
BLV
HDD
where CRI(t) is a compensatory reserve at time t, BLV(t) is an intravascular volume loss of the patient at time t, and BLVHDD is an intravascular volume loss at a point of hemodynamic decompensation of the patient,
wherein the physiological data includes waveform data of the patient, wherein waveform data of the patient includes one or more patient waveforms,
wherein comparing the physiological data against the model comprises comparing the waveform data of the patient against the plurality of waveforms of reference data, and
determining a similarity between a respective patient waveform of the one or more patient waveforms and each of one or more waveforms of the plurality of waveforms of reference data individually, and
wherein estimating the CRI value of the patient is based at least in part on respective similarities of the respective patient waveform to each of the one or more waveforms of the plurality of waveforms of reference data individually,
wherein estimating the blood pressure value of the patient and the at least one of the dehydration state of the patient, the state of euvolemia of the patient, the state of hypervolemia of the patient, or the probability of bleeding of the patient includes comparing the CRI value of the patient to an empirical model, wherein the empirical model is separate from the model comprising the plurality of waveform data, wherein the blood pressure value and the at least one of the dehydration state of the patient, the state of euvolemia of the patient, the state of hypervolemia of the patient, or the probability of bleeding of the patient are related to the CRI value of the patient by the empirical model, wherein the empirical model is generated based on a test population, wherein the empirical model relates respective blood pressure values and at least one of the state of euvolemia, the state of hypovolemia, or the probability of bleeding to respective CRI values; and
instructions for displaying, on a display device, an estimate of the blood pressure value of the patient.

### Claim 2 (depends on 1)

The system of claim 1, wherein the one or more sensors comprises a finger cuff comprising a fingertip photoplethysmograph and wherein the computer system further comprises a wrist unit in communication with the fingertip photoplethysmograph, the wrist unit further comprising a wrist strap.

### Claim 3

A method, comprising:
monitoring, with one or more sensors, physiological data of a patient, wherein the physiological data is cardiovascular data of the patient;
estimating a blood pressure value of the patient,
wherein estimating the blood pressure value includes estimating a compensatory reserve index (“CRI”) value of the patient and estimating the blood pressure value from the estimated CRI value, wherein the CRI value of the patient is further used to estimate at least one of a dehydration state of the patient, a state of euvolemia of the patient, a state of hypervolemia of the patient, or a probability of bleeding of the patient,
wherein estimating the CRI value of the patient includes comparing the physiological data to a model, the model comprising a plurality of waveforms of reference data, each waveform of the plurality of waveforms corresponding to a respective CRI value determined using the following formula:
CRI
⁡
(
t
)
=
1
-
BLV
⁡
(
t
)
BLV
HDD
where CRI(t) is a compensatory reserve at time t, BLV(t) is an intravascular volume loss of the patient at time t, and BLVHDD is an intravascular volume loss at a point of hemodynamic decompensation of the patient,
wherein the physiological data includes waveform data of the patient, wherein waveform data of the patient includes one or more patient waveforms,
wherein comparing the physiological data against the model comprises comparing the waveform data of the patient against the plurality of waveforms of reference data, and
determining a similarity between a respective patient waveform of the one or more patient waveforms and each of one or more waveforms of the plurality of waveforms of reference data individually, and
wherein estimating the CRI value of the patient is based at least in part on respective similarities of the respective patient waveform to each of the one or more waveforms of the plurality of waveforms of reference data individually,
wherein estimating the blood pressure value of the patient and the at least one of the dehydration state of the patient, the state of euvolemia of the patient, the state of hypervolemia of the patient, or the probability of bleeding of the patient includes comparing the CRI value of the patient to an empirical model, wherein the empirical model is separate from the model comprising the plurality of waveform data, wherein the blood pressure value and the at least one of the dehydration state of the patient, the state of euvolemia of the patient, the state of hypervolemia of the patient, or the probability of bleeding of the patient are related to the CRI value of the patient by the empirical model, wherein the empirical model is generated based on a test population, wherein the empirical model relates respective blood pressure values and at least one of the state of euvolemia, the state of hypovolemia, or the probability of bleeding to respective CRI values; and
displaying, on a display device, an estimate of the blood pressure value of the patient.

### Claim 4 (depends on 3)

The method of claim 3, wherein the blood pressure value of the patient is a future blood pressure value of the patient.

### Claim 5 (depends on 3)

The method of claim 3, wherein the blood pressure value of the patient is a numeric value.

### Claim 6 (depends on 3)

The method of claim 3, wherein the blood pressure value of the patient is a qualitative value selected from the group consisting of low blood pressure, normal blood pressure, and high blood pressure.

### Claim 7 (depends on 3)

The method of claim 3, wherein estimating a blood pressure of the patient further comprises performing one or more operations selected from the group consisting of estimating that the patient's blood pressure is high; estimating that the patient's blood pressure is normal; and identifying when the patient's blood pressure changes significantly over a time period.

### Claim 8 (depends on 3)

The method of claim 3, wherein estimating a blood pressure value of the patient further comprises performing one or more operations selected from the group consisting of: predicting when the patient's blood pressure will increase to a specific value; predicting when the patient's blood pressure will decrease to a specific value; predicting when the patient's blood pressure will increase by a specified amount; and/or predicting when the patient's blood pressure will decrease by a specified amount.

### Claim 9 (depends on 3)

The method of claim 3, wherein estimating the blood pressure value further comprises estimating a plurality of values of the compensatory reserve index over time and estimating the blood pressure value based on changes in values of the compensatory reserve index over time.

### Claim 10 (depends on 9)

The method of claim 9, wherein estimating the blood pressure value based on changes in values of the compensatory reserve index over time further comprises estimating the blood pressure value based on a slope of a plot of compensatory reserve index values over a time segment.

### Claim 11 (depends on 3)

The method of claim 3, wherein the plurality of waveforms of reference data are generated from waveforms of physiological signals obtained from one or more test subjects of the test population exposed to a state of hemodynamic decompensation or near hemodynamic decompensation, or a series of states progressing towards hemodynamic decompensation.

### Claim 12 (depends on 3)

The method of claim 3, wherein determining the similarity between the respective patient waveform and each of the one or more waveforms of the plurality of waveforms of reference data individually further comprises:
producing one or more similarity coefficients, each similarity coefficient of the one or more similarity coefficients indicating a respective similarity between the respective patient waveform and each of the one or more waveforms of the plurality of waveforms of reference data individually;
wherein estimating the CRI value of the patient further comprises:
normalizing each of the one or more similarity coefficients of the one or more waveforms of the plurality of waveforms of reference data;
summing each respective CRI value, corresponding to a respective individual waveform of the one or more waveforms of the plurality of waveforms of reference data, weighted by the normalized similarity coefficient corresponding to the respective individual waveform of the one or more waveforms of the plurality of waveforms of reference data, for each of the one or more waveforms of the plurality of waveforms of reference data; and
determining, for the respective patient waveform, an estimated CRI value for the patient based on the sum of each of the respective CRI values as weighted by the normalized similarity coefficient.

### Claim 13 (depends on 3)

The method of claim 3, further comprising:
predicting, with the computer system, the blood pressure value of the patient at one or more time points in the future, based on analysis of the physiological data; and
displaying, with the display device, a predicted blood pressure value of the patient at one or more points in the future.

### Claim 14 (depends on 3)

The method of claim 3, wherein the estimate of the blood pressure value of the patient is based on a fixed time history of monitoring the physiological data of the patient.

### Claim 15 (depends on 3)

The method of claim 3, wherein the estimate of the blood pressure value of the patient is based on a dynamic time history of monitoring the physiological data of the patient.

### Claim 16 (depends on 3)

The method of claim 3, wherein blood pressure value is a systolic value of the patient's blood pressure.

### Claim 17 (depends on 3)

The method of claim 3, wherein blood pressure value is a diastolic value of the patient's blood pressure.

### Claim 18 (depends on 3)

The method of claim 3, wherein blood pressure value is a mean arterial pressure value of the patient's blood pressure.

### Claim 19 (depends on 3)

The method of claim 3, wherein at least one of the one or more sensors is selected from the group consisting of a blood pressure sensor, an intracranial pressure monitor, a central venous pressure monitoring catheter, an arterial catheter, an electroencephalograph, a cardiac monitor, a transcranial Doppler sensor, a transthoracic impedance plethysmograph, a pulse oximeter, a near infrared spectrometer, a ventilator, an accelerometer, and an electronic stethoscope.

### Claim 20 (depends on 3)

The method of claim 3, wherein the physiological data comprises blood pressure waveform data.

### Claim 21 (depends on 3)

The method of claim 3, wherein the physiological data comprises plethysmograph waveform data.

### Claim 22 (depends on 3)

The method of claim 3, wherein the physiological data comprises photoplethysmograph (PPG) waveform data.

### Claim 23 (depends on 3)

The method of claim 3, wherein the empirical model is related to respective blood pressure values and at least one of the state of euvolemia, the state of hypovolemia, and the probability of bleeding by:
directly measuring one or more physiological states of the test subject with a reference sensor to obtain a plurality of physiological state measurements; and
correlating the compensatory reserve index value of the test subject with the physiological state measurements of the test subject.

### Claim 24 (depends on 23)

The method of claim 23, wherein the one or more physiological states comprises one or more states selected from the group consisting of reduced circulatory system volume, dehydration, cardiovascular collapse or near-cardiovascular collapse, euvolemia, hypervolemia, high blood pressure, normal blood pressure, low blood pressure, and blood pressure at a specific numeric value.

### Claim 25 (depends on 23)

The method of claim 23, wherein correlating the CRI value of the test subject with the physiological state measurements of the test subject further comprises:
identifying a most predictive set of signals Sk out of a set of signals s1, s2, . . . , sD for each of one or more outcomes ok, wherein the most-predictive set of signals Sk corresponds to a first data set representing a first physiological parameter representing CRI values of the test subject, and wherein each of the one or more outcomes ok represents a physiological state measurement of the one or more physiological states respectively;
autonomously learning a set of probabilistic predictive models ôk=Mk(Sk), where ôk is a prediction of outcome ok derived from Mk that uses as inputs values obtained from the set of signals Sk; and
repeating the operation of autonomously learning incrementally from data that contains examples of values of signals s1, s2, . . . , sD and corresponding outcomes o1, o2, . . . , oK.

### Claim 26 (depends on 3)

The method of claim 3, further comprising controlling a therapeutic device in response to an estimated blood pressure value of the patient.

### Claim 27

An apparatus, comprising:
a non-transitory computer readable medium having encoded thereon a set of instructions executable by one or more computers to perform one or more operations, the set of instructions comprising:
instructions for receiving physiological data of a patient from one or more sensors, wherein the physiological data is cardiovascular data of the patient;
instructions for estimating a blood pressure value of the patient,
wherein estimating the blood pressure value includes estimating a compensatory reserve index (“CRI”) value of the patient and estimating the blood pressure value from the estimated CRI value, wherein the CRI value of the patient is further used to estimate at least one of a dehydration state of the patient, a state of euvolemia of the patient, a state of hypervolemia of the patient, or a probability of bleeding of the patient,
wherein estimating the CRI value of the patient includes comparing the physiological data to a model, the model comprising a plurality of waveforms of reference data, each waveform of the plurality of waveforms corresponding to a respective CRI value determined using the following formula:
CRI
⁡
(
t
)
=
1
-
BLV
⁡
(
t
)
BLV
HDD
where CRI(t) is a compensatory reserve at time t, BLV(t) is an intravascular volume loss of the patient at time t, and BLVHDD is an intravascular volume loss at a point of hemodynamic decompensation of the patient,
wherein the physiological data includes waveform data of the patient, wherein waveform data of the patient includes one or more patient waveforms,
wherein comparing the physiological data against the model comprises comparing the waveform data of the patient against the plurality of waveforms of reference data, and
determining a similarity between a respective patient waveform of the one or more patient waveforms and each of one or more waveforms of plurality of waveforms of reference data individually, and
wherein estimating the CRI value of the patient is based at least in part on respective similarities of the respective patient waveform to each of the one or more waveforms of the plurality of waveforms of reference data individually,
wherein estimating the blood pressure value of the patient and the at least one of the dehydration state of the patient, the state of euvolemia of the patient, the state of hypervolemia of the patient, or the probability of bleeding of the patient includes comparing the CRI value of the patient to an empirical model, wherein the empirical model is separate from the model comprising the plurality of waveform data, wherein the blood pressure value and the at least one of the dehydration state of the patient, the state of euvolemia of the patient, the state of hypervolemia of the patient, or the probability of bleeding of the patient are related to the CRI value of the patient by the empirical model, wherein the empirical model is generated based on a test population, wherein the empirical model relates respective blood pressure values and at least one of the state of euvolemia, the state of hypovolemia, or the probability of bleeding to respective CRI values; and
instructions for displaying, on a display device, an estimate of the blood pressure value of the patient.