# US 12,109,024 B2 · Pulse oximetry device, system and method

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- Number: US 12,109,024 B2
- Document ID: US12109024B2
- Status: Granted
- Kind: B2
- Application number: 17/045,272
- Filed: 2019-04-05
- Published: 2021-06-10
- Granted: 2024-10-08
- Earliest claimed: 2018-04-05
- Assignees: Life Meter Srl
- Applicants: Life Meter Srl
- Inventors: Fernando De Benedetto; Alberto Visconti; Marco Raimondi; Matteo Aventaggiato
- Web page: https://patentgrep.com/patent/US12109024B2

## CPC

- A61B 5/1495: Calibrating or testing of in-vivo probes
- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/14551: {for measuring blood gases}
- A61B 5/14552: {Details of sensors specially adapted therefor}
- A61B 5/6802: {Sensor mounted on worn items}
- A61B 5/6824: {Arm or wrist}
- A61B 5/6833: {Adhesive patches}
- G16H 10/60: for patient-specific data, e.g. for electronic patient records
- G16H 40/40: for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
- G16H 40/67: for remote operation
- G16H 50/30: for calculating health indices; for individual health risk assessment
- G16H 50/70: for mining of medical data, e.g. analysing previous cases of other patients
- A61B 5/02433: {for infrared radiation}
- A61B 2560/0214: of power generation or supply
- A61B 2560/0238: Means for recording calibration data
- A61B 2560/0456: Apparatus provided with a docking unit
- 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

A method of measuring blood oxygenation consists of measuring Sp02 on one or more test subjects using a first, reference pulse oximetry device (100), such as a medical- grade pulse-oximeter of the kind that employs, for example, a finger-tip clip-type probe. This can be done on each patient over relatively short time periods. Then, the Sp02 is monitored on a target subject across a relatively longer time period using a second, wearable pulse oximetry device (10) that can be worn non-intrusively by the target use, for example in the form of a bracelet. The Sp02 measured using the wearable pulse oximetry device (10), can be measured based on calibration measurements performed using the first, reference pulse oximetry device (100). In this way, the measurements produced by the wearable pulse oximetry device (10) are calibrated using a medical-grade pulse- oximeter (100).

## Claims

### Claim 1

A method of taking pulse oximetry measurements, the method comprising:
providing a first, reference pulse-oximeter adapted to measure reference Oxygen saturation (SpO2) values on a basis of a first predetermined pulse oximetry parameter calculated from a first, reference Photoplethysmography (PPG) signal measured by the reference pulse-oximeter on a non-wrist body portion sufficiently perfused with arterial blood of each of one or more test subjects;
using said first, reference pulse-oximeter, measuring reference SpO2 values for multiple measurements carried out on the non-wrist body portion of each of the one or more test subjects;
from the reference SpO2 values, obtaining a calibration relationship that expresses SpO2 as a function of the first predetermined pulse oximetry parameter;
providing a second, bracelet-type pulse oximetry device adapted to acquire SpO2 a second PPG signal on a wrist of a target subject, wherein the device is adapted to calculate therefrom a second predetermined pulse oximetry parameter;
using the second, bracelet-type pulse oximetry device, performing one or more acquisitions of the second PPG signal on the wrist of the target subject;
calculating from the one or more acquisitions of the second PPG signal one or more corresponding values of the second predetermined pulse oximetry parameter;
converting said one or more corresponding values of the second predetermined pulse oximetry parameter into measured SpO2 values using said calibration relationship.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the first predetermined pulse oximetry parameter and the second predetermined pulse oximetry parameter are the same parameter derived from respectively the first, reference PPG signal and the second PPG signal.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the first, reference pulse-oximeter is a medical-grade, medically certified pulse-oximeter.

### Claim 4 (depends on 2)

The method according to claim 2, wherein the first, reference pulse-oximeter comprises at least one light emitter and at least one light detector adapted to detect light emitted by said light emitter after the light has passed through a human tissue;
wherein the light detector is adapted to measure a light intensity.

### Claim 5 (depends on 4)

The method according to claim 4, wherein the first, reference pulse-oximeter comprises two light emitters for emitting two respective substantially monochromatic lights at different wavelengths, wherein said different wavelengths comprise a red wavelength and an infrared wavelength.

### Claim 6 (depends on 5)

The method according to claim 5, wherein the first predetermined pulse oximetry parameter derived from the first, reference PPG signal and/or the second predetermined pulse oximetry parameter derived from the second PPG signal is a parameter R calculated as follows:
R
=
RedAC
/
RedDC
InfraRedAC
/
InfraRedDC
,
wherein,
RedAC is an amplitude of the alternating (AC) component of the light having the red wavelength;
RedDC is an amplitude of the continuous (DC) component of the light having the red wavelength;
InfraRedAC is an AC component of the light having the infrared wavelength; and,
InfraRedDC is a DC component of the light having the infrared wavelength.

### Claim 7 (depends on 1)

The method according to claim 1, wherein obtaining said calibration relationship from said estimated reference SpO2 values comprises interpolating said estimated reference SpO2 values;
wherein said interpolating comprises linearly interpolating said estimated reference SpO2 values.

### Claim 8 (depends on 1)

The method according to claim 1, further comprising:
storing the reference SpO2 values and/or said calibration relationship in a memory provided in the second, bracelet-type pulse oximetry device.

### Claim 9 (depends on 1)

The method according to claim 1, further comprising:
correcting said reference SpO2 values and/or said calibration relationship;
wherein said correcting depends on, or is specific to, the target subject;
wherein said correcting comprises subtracting an offset value from said reference SpO2 values and/or from said calibration relationship.
