# US 10,863,937 B2 · Ex vivo calibration of a photoplethysmographic device

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- Number: US 10,863,937 B2
- Document ID: US10863937B2
- Status: Granted
- Kind: B2
- Application number: 15/903,939
- Filed: 2018-02-23
- Published: 2019-08-29
- Granted: 2020-12-15
- Earliest claimed: 2018-02-23
- Assignees: Kestrel Labs, Inc.
- Applicants: Jonas Alexander Pologe
- Inventors: Jonas Alexander Pologe
- Web page: https://patentgrep.com/patent/US10863937B2

## CPC

- A61B 5/1495: Calibrating or testing of in-vivo probes
- A61B 5/02416: {using photoplethysmograph signals, e.g. generated by infrared radiation (A61B5/14552 takes precedence)}
- G01N 33/4925: {measuring blood gas content, e.g. O2, CO2 , HCO3}
- A61B 5/14551: {for measuring blood gases}
- A61B 2560/0223: of calibration, e.g. protocols for calibrating sensors
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

A method for calibration of a photoplethysmographic device including the steps of providing a fluid circuit (305) for blood or other liquid, a pump mechanism (310) to generate pulsatile flow of blood through the fluid circuit, a sample of excised tissue (315) in the fluid circuit through which the blood flows, and a photoplethysmographic device including an emitter and a photodetector (330) positioned on the tissue (335, 340) so that a portion of the light output by the emitter passes through the tissue and is incident on the photodetector. The method further includes the steps of energizing the pump mechanism (420) to move the blood through the tissue, energizing the emitter (425) to output light, collecting paired data from the photodetector and from one or more reference measurements (430), and processing the paired data to calibrate the photoplethysmographic device (435).

## Claims

### Claim 1

A method for in vitro calibration of a photoplethysmographic device comprising the steps of:
a. providing a fluid circuit;
b. incorporating a pump mechanism in the fluid circuit;
c. providing an excised tissue that includes at least one artery and a venous return portion;
d. configuring the pump mechanism to generate pulsatile output fluid flow through the fluid circuit;
e. connecting the pulsatile output fluid flow to the at least one artery of the excised tissue to incorporate the excised tissue in the fluid circuit;
f. providing a photoplethysmographic device including an emitter and a photodetector;
g. positioning the emitter so that light output by the emitter is incident on the excised tissue;
h. positioning the photodetector so that a portion of the light output by the emitter passes through the excised tissue and is incident on the photodetector;
i. introducing blood into the fluid circuit to be input to the pump mechanism;
j. incorporating a sample access port in the fluid circuit for sampling the blood in the fluid circuit and for running the sampled blood through a reference instrument to obtain reference measurements;
k. energizing the pump mechanism to move the blood through the excised tissue;
l. energizing the emitter to output light;
m. pairing data from the photodetector and one or more reference measurements of the obtained reference measurements; and
n. processing the paired data to calibrate the photoplethysmographic device.

### Claim 2 (depends on 1)

The method of claim 1 including the step of connecting the fluid circuit to the venous return portion of the excised tissue.

### Claim 3 (depends on 2)

The method of claim 2 wherein the blood in the fluid circuit is enclosed to prevent exposure of the blood to ambient air.

### Claim 4 (depends on 1)

The method of claim 1 including the step of incorporating a tonometer into the fluid circuit to set a partial pressure of one or more gases in the blood in the fluid circuit.

### Claim 5 (depends on 1)

The method of claim 1 wherein the one or more reference measurements comprises reference measurements of blood analytes.

### Claim 6 (depends on 1)

The method of claim 1 wherein the one or more reference measurements comprises reference measurements of hemodynamic parameters including at least one of heart rate, respiratory rate, circulating blood volume, perfusion index, and blood pressure.