# US 11,076,813 B2 · Mean arterial pressure (MAP) derived prediction of future hypotension

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- Number: US 11,076,813 B2
- Document ID: US11076813B2
- Status: Granted
- Kind: B2
- Application number: 15/649,438
- Filed: 2017-07-13
- Published: 2018-01-25
- Granted: 2021-08-03
- Earliest claimed: 2016-07-22
- Assignees: Edwards Lifesciences Corporation
- Applicants: Edwards Lifesciences Corporation
- Inventors: Feras Al Hatib; Zhongping Jian
- Web page: https://patentgrep.com/patent/US11076813B2

## 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 5/02108: {from analysis of pulse wave characteristics}
- A61B 5/6826: {Finger}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- G16H 40/63: for local operation
- G16H 50/30: for calculating health indices; for individual health risk assessment
- G16H 50/50: for simulation or modelling of medical disorders
- A61B 5/02241: {of small dimensions, e.g. adapted to fingers}
- A61B 5/7267: {involving training the classification device}
- A61B 2505/01: Emergency care
- A61B 2505/03: Intensive care
- A61B 2505/05: Surgical care
- 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

## Abstract

There are provided systems and methods for performing mean arterial pressure (MAP) derived prediction of future hypotension. Such a system includes a hardware unit including a hardware processor and a system memory, a hypotension prediction software code stored in the system memory, and a sensory alarm. The hardware processor is configured to execute the hypotension prediction software code to receive MAP data of the living subject, and to transform the MAP data to one or more parameters predictive of a future hypotension event of the living subject. The hardware processor is further configured to execute the hypotension prediction software code to determine a risk score of the living subject corresponding to the probability of the future hypotension event based on at least some of the one or more parameters, and to invoke the sensory alarm if the risk score of the living subject satisfies a predetermined risk criteria.

## Claims

### Claim 1

A system for monitoring arterial pressure of a patient and providing a warning to medical personnel of a predicted future hypotension event, the system comprising:
a hemodynamic sensor that produces, on an ongoing basis, an analog hemodynamic sensor signal representative of an arterial pressure waveform of the patient;
an analog-to-digital converter that converts the analog hemodynamic sensor signal to digital data including mean arterial pressure (MAP) data, wherein the MAP data includes data which can be utilized to determine mean arterial pressure (MAP) and data derived from indicia predictive of future hypotension;
a system memory that stores hypotension prediction software code;
a user interface that includes a sensory alarm that provides a sensory signal to warn medical personnel of the predicted future hypotension event prior to the patient entering a hypotension state; and
a hardware processor that is configured to execute the hypotension prediction software code to:
transform the MAP data to obtain one or more parameters predictive of a future hypotension event of the patient wherein the one or more parameters predictive of a future hypotension event of the patient include mean arterial pressure (MAP);
determine a risk score representing a probability of the future hypotension event for the patient based on at least one of the one or more parameters predictive of the future hypotension event of the patient, wherein the risk score is determined by the hardware processor based upon MAP and wherein the risk score is determined by a formula: risk score=1/(1+e−((a*MAP+b)); and
invoke the sensory alarm to produce the sensory signal in response to the risk score satisfying a predetermined risk criterion.

### Claim 2 (depends on 1)

The system of claim 1, wherein the hardware processor is configured to execute the hypotension prediction software code to determine the risk score of the patient without reference to stored information regarding hypotension in other patients.

### Claim 3 (depends on 1)

The system of claim 1, wherein the hardware processor is further configured to execute the hypotension prediction software code to invoke the sensory alarm by displaying the risk score of the patient on a display screen.

### Claim 4 (depends on 1)

The system of claim 1, wherein the hemodynamic sensor is a noninvasive hemodynamic sensor that is attachable to an extremity of the patient.

### Claim 5 (depends on 1)

The system of claim 1, wherein the hemodynamic sensor is a minimally invasive arterial catheter based hemodynamic sensor.

### Claim 6 (depends on 1)

The system of claim 1, wherein the sensory alarm comprises a visual alarm.

### Claim 7 (depends on 1)

The system of claim 1, wherein the sensory alarm comprises an audible alarm.

### Claim 8 (depends on 1)

The system of claim 1, wherein the sensory alarm comprises a haptic alarm.

### Claim 9 (depends on 1)

The system of claim 1, wherein the hardware processor is configured to invoke the sensory alarm immediately when the risk score satisfies a first risk criterion.

### Claim 10 (depends on 9)

The system of claim 9, wherein the hardware processor is configured to invoke the sensory alarm when the risk score satisfies a second risk criterion continuously for a first predetermined time period.

### Claim 11 (depends on 10)

The system of claim 10, wherein the hardware processor is configured to invoke the sensory alarm when the risk score satisfies a third risk criterion continuously for a second, longer, predetermined time period.

### Claim 12 (depends on 10)

The system of claim 10, wherein the hardware processor is configured to invoke the sensory alarm when the risk score satisfies a fourth risk criterion a predetermined number of times over a predetermined time interval.

### Claim 13 (depends on 1)

The system of claim 1, wherein MAP is determined by the hardware processor based upon cardiac output (CO) data, systemic vascular resistance (SVR) data, and central venous pressure (CVP) data.

### Claim 14 (depends on 1)

The system of claim 1, wherein MAP is determined by the hardware processor based upon systolic pressure (SP) and diastolic pressure (DP).

### Claim 15 (depends on 1)

The system of claim 1, wherein a, b, and MAP are included in the one or more parameters predictive of a future hypotension event.

### Claim 16 (depends on 1)

The system of claim 1, wherein parameters a and b are predetermined and fixed.

### Claim 17 (depends on 1)

The system of claim 1, wherein parameters a and b are variables.

### Claim 18 (depends on 1)

The system of claim 1, wherein parameters a and b are obtained by the hardware processor by transformation of the MAP data.

### Claim 19 (depends on 1)

The system of claim 1, wherein the hardware processor converts the risk score to a percentage risk score between zero percent and one hundred percent.

### Claim 20

A system for monitoring arterial pressure of a patient and providing a warning to medical personnel of a predicted future hypotension event, the system comprising:
a hemodynamic sensor that produces, on an ongoing basis, an analog hemodynamic sensor signal representative of an arterial pressure waveform of the patient;
an analog-to-digital converter that converts the analog hemodynamic sensor signal to digital data which can be utilized to determine mean arterial pressure (MAP);
a system memory that stores hypotension prediction software code;
a user interface that includes a sensory alarm that provides a sensory signal to warn medical personnel of the predicted future hypotension event prior to the patient entering a hypotension state; and
a hardware processor that is configured to execute the hypotension prediction software code to:
determine a risk score representing a probability of the future hypotension event for the patient, wherein the risk score is determined by the hardware processor based upon MAP and, wherein the risk score is determined by a formula: risk score=1/(1+e−((a*MAP+b)); and
invoke the sensory alarm to produce the sensory signal in response to the risk score satisfying a predetermined risk criterion,
wherein the hardware processor is configured to invoke the sensory alarm immediately when the risk score satisfies a first risk criterion,
wherein the hardware processor is configured to invoke the sensory alarm when the risk score satisfies a second risk criterion continuously for a first predetermined time period, and
wherein the hardware processor is configured to invoke the sensory alarm when the risk score satisfies a third risk criterion continuously for a second, longer, predetermined time period.

### Claim 21 (depends on 20)

The system of claim 20, wherein the hardware processor is configured to invoke the sensory alarm when the risk score satisfies a fourth risk criterion a predetermined number of times over a predetermined time interval.

### Claim 22 (depends on 20)

The system of claim 20, wherein the hardware processor is configured to execute the hypotension prediction software code to determine the risk score of the patient without reference to stored information regarding hypotension in other patients.

### Claim 23 (depends on 20)

The system of claim 20, wherein the hardware processor is further configured to execute the hypotension prediction software code to invoke the sensory alarm by displaying the risk score of the patient on a display screen.

### Claim 24 (depends on 20)

The system of claim 20, wherein the hardware processor converts the risk score to a percentage risk score between zero percent and one hundred percent.

### Claim 25 (depends on 20)

The system of claim 20, wherein the sensory alarm comprises a visual alarm.

### Claim 26 (depends on 20)

The system of claim 20, wherein the sensory alarm comprises an audible alarm.

### Claim 27 (depends on 20)

The system of claim 20, wherein the sensory alarm comprises a haptic alarm.
