# US 10,869,631 B2 · Method and system for assessing fluid responsiveness using multimodal data

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- Number: US 10,869,631 B2
- Document ID: US10869631B2
- Status: Granted
- Kind: B2
- Application number: 15/536,163
- Filed: 2015-12-09
- Published: 2017-12-21
- Granted: 2020-12-22
- Earliest claimed: 2014-12-17
- Assignees: Koninklijke Philips N.V.
- Applicants: Koninklijke Philips N.V.
- Inventors: Cristhian Potes; Bryan Conroy; Adam Jacob Seiver; Minnan Xu; Larry James Eshelman
- Web page: https://patentgrep.com/patent/US10869631B2

## CPC

- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/02405: {Determining heart rate variability}
- A61B 5/02416: {using photoplethysmograph signals, e.g. generated by infrared radiation (A61B5/14552 takes precedence)}
- A61B 5/0245: by using sensing means generating electric signals, {i.e. ECG signals}
- A61B 5/0836: {Measuring rate of CO2 production}
- A61B 5/335: using integrated circuit memory devices
- A61B 5/352: Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
- A61B 5/4833: {Assessment of subject's compliance to treatment}
- A61B 5/4839: {combined with drug delivery}
- A61B 5/7267: {involving training the classification device}
- A61B 5/7289: {Retrospective gating, i.e. associating measured signals or images with a physiological event after the actual measurement or image acquisition, e.g. by simultaneously recording an additional physiological signal during the measurement or image acquisition}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H 40/67: for remote operation
- A61B 5/02028: {Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction}
- A61B 5/02055: {Simultaneously evaluating both cardiovascular condition and temperature}
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/082: {Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath (A61B5/083, A61B5/091 take precedence)}
- A61B 5/087: Measuring breath flow
- A61B 5/091: Measuring volume of inspired or expired gases, e.g. to determine lung capacity
- 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}
- A61M 2005/14208: {with a programmable infusion control system, characterised by the infusion program}
- A61M 2205/50: with microprocessors or computers
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- G16H 20/17: delivered via infusion or injection
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A system (100) for assessing fluid responsiveness includes an infusion pump (24) in communication with at least one processor (32), and a plurality of physiological monitors (40,42,44,46) operable to receive physiological signals from an associated patient. Physiological signals (48,50) acquired from the associated patient (10) during a fluid challenge are synchronized with a timing signal (54) of the infusion pump (24) administering the fluid challenge. One or more dynamic indices and/or features (58) is calculated from the synchronized physiological signals (50), and one or more dynamic indices and/or features (50) is calculated from baseline physiological signals (48) acquired from the associated patient (10) prior to the fluid challenge. A fluid responsiveness probability value (64) of the patient (10) is determined based on dynamic indices and/or features (58) from the synchronized physiological signals (50) and dynamic indices and/or features (50) from the baseline physiological signals (48).

## Claims

### Claim 1

A system for assessing fluid responsiveness, the system comprising:
at least one processor;
an infusion pump, configured to administer a fluid challenge to an associated patient, wherein the infusion pump is in communication with the at least one processor; and,
a plurality of physiological monitors configured to receive physiological signals from the associated patient, wherein the at least one processor is programmed to:
receive, from the infusion pump administering the fluid challenge to the associated patient, a timing signal corresponding to an infusion of fluids by the infusion pump during the administration of the fluid challenge to the associated patient;
synchronize physiological signals acquired from the associated patient during the administration of the fluid challenge with the timing signal of the infusion pump so as to indicate an amount of fluid provided to the associated patient in correlation with the corresponding physiological signals at a given time, wherein each of the physiological signals being synchronized are acquired from a beginning to an end of the fluid challenge;
calculate one or more dynamic indices and/or features from the synchronized physiological signals; and
determine a fluid responsiveness probability value of the patient responsive to the one or more dynamic indices and/or features from the synchronized physiological signals.

### Claim 2 (depends on 1)

The system according to claim 1, wherein the at least one processor is further programmed to:
terminate operations of the infusion pump responsive to the fluid responsiveness probability value indicative of the patient being non-responsive to fluid resuscitation.

### Claim 3 (depends on 2)

The system according to claim 2, wherein the at least one processor is further programmed to:
calculate the one or more dynamic indices and/or features from baseline physiological signals acquired from the patient prior to the administration of the fluid challenge, wherein determining the fluid responsiveness probability value of the patient is responsive to the one or more dynamic indices and/or features from the synchronized physiological signals and the one or more dynamic indices and/or features from the baseline physiological signals.

### Claim 4 (depends on 3)

The system according to claim 3, wherein determining the fluid responsiveness probability value further comprises:
inputting the one or more dynamic indices and/or features from the synchronized physiological signals and the one or more dynamic indices and/or features from the baseline physiological signals into a classification algorithm.

### Claim 5 (depends on 4)

The system according to claim 4, wherein the fluid responsiveness probability value is between 0 indicating non-responsiveness and 1 indicating responsiveness.

### Claim 6 (depends on 5)

The system according to claim 5, wherein the at least one processor is further programmed to:
compare the determined fluid responsiveness probability value to a preselected threshold value, wherein the associated patient is responsive to fluid resuscitation when the determined fluid responsiveness probability value is greater than or equal to the preselected threshold value.

### Claim 7 (depends on 3)

The system according to claim 3, wherein the at least one processor is further programmed to:
calculate the one or more dynamic indices and/or features from the synchronized physiological signals and the one or more dynamic indices and/or features from the baseline physiological signals during an expiration portion of a respiratory cycle of the associated patient.

### Claim 8 (depends on 1)

The system according to claim 1, wherein the at least one processor is further programmed to:
generate an alarm in response to the determined fluid responsiveness probability value indicating the associated patient is not responsive to fluid resuscitation.

### Claim 9 (depends on 1)

The system according to claim 1, wherein the infusion pump is a rapid infusion pump that is synchronized with the physiological signals and configured to:
infuse a fluid during an expiration portion of a respiratory cycle of the associated patient.

### Claim 10 (depends on 1)

The system according to claim 1, wherein the plurality of physiological monitors comprise one or more of a capnography monitor, an arterial blood pressure (ABP) monitor, an electrocardiographic (ECG) monitor, and a plethysmograph (PPG) monitor.

### Claim 11 (depends on 1)

The system according to claim 1, wherein the dynamic indices and/or features comprise at least one of pulse pressure variability (PPV), stroke volume variability (SVV), systolic pressure variability (SPV), RR variability (RRV), pleth variability index (PVI), volumetric capnography, end-tidal CO2 derived from capnography, and a cardiac output derived from an arterial blood pressure (ABP).

### Claim 12

A method for assessing fluid responsiveness, the method comprising:
administering, with an infusion pump, a fluid challenge to an associated patient;
receiving, during the administration of the fluid challenge, a plurality of physiological signals from a plurality of physiological monitors of the associated patient;
receiving an infusion pump timing signal corresponding to the infusion of fluids by the associated infusion pump in association with the administration of the fluid challenge to the associated patient;
synchronizing the timing signal with the received plurality of physiological signals so as to generate synchronized physiological signals to indicate an amount of fluid provided to the associated patient in correlation with the corresponding physiological signals at a given time, wherein each of the plurality of physiological signals being synchronized are acquired from a beginning to an end of the fluid challenge;
calculating at least one of a plurality of dynamic indices and/or features from the synchronized plurality of physiological signals; and
calculating a fluid responsiveness probability value indicative of a responsiveness of the associated patient to fluid resuscitation.

### Claim 13 (depends on 12)

The method according to claim 12, further comprising:
terminating the fluid challenge in response to the fluid responsiveness probability value indicative of the associated patient being non-responsive to the fluid resuscitation.

### Claim 14 (depends on 13)

The method according to claim 13, further comprising:
receiving baseline physiological signals from the plurality of physiological monitors of the associated patient prior to initiation of the fluid challenge; and
calculating at least one of a plurality of dynamic indices and/or features from the baseline physiological signal signals in accordance with the baseline dynamic indices and/or features and the fluid challenge dynamic indices and/or features.

### Claim 15 (depends on 14)

The method according to claim 14, wherein calculating the fluid responsiveness probability value further comprises:
applying the one or more dynamic indices and/or features from the synchronized plurality of physiological signals and the one or more dynamic indices and/or features from the baseline physiological signals into a classification algorithm.

### Claim 16 (depends on 12)

The method according to claim 12, further comprising:
generating an alarm responsive to the fluid responsiveness probability value indicative of the associated patient being non-responsive to the fluid resuscitation.

### Claim 17 (depends on 12)

The method according to claim 12, further comprising:
generating a display of a likelihood of responding to the fluid resuscitation of the associated patient responsive to the calculated fluid responsiveness probability value.

### Claim 18 (depends on 12)

The method according to claim 12, wherein the dynamic indices and/or features comprise at least one of a pulse pressure variability (PPV), a stroke volume variability (SVV), a systolic pressure variability (SPV), a RR variability (RRV), and a pleth variability index (PVI).

### Claim 19 (depends on 12)

A computer medium storing instructions executable to control a computer and a display to perform the method of claim 12.

### Claim 20 (depends on 12)

A system configured to assess the fluid responsiveness of an associated patient to fluid resuscitation including a processor programmed to perform the method of claim 12.