EP-4737883-A2 - SYSTEM FOR NON-INVASIVE MEASUREMENT OF AN ANALYTE IN A VEHICLE DRIVER

EP4737883A2EP 4737883 A2EP4737883 A2EP 4737883A2EP-4737883-A2

Abstract

The invention refers to a sample interface device for use in identifying the presence of an analyte in a sample, wherein the sample interface device delivers a plurality of light beams to a sample and receives back scattered light from the sample, the sample interface device comprising: - a substrate; - a low-absorbance injection area carried by the substrate for receiving a plurality of light beams and delivering a portion of the plurality of light beams to the sample; and - a plurality of photosensors carried by the substrate, wherein the plurality of photosensors are disposed outboard of the low-absorbance injection area, and further wherein each of the photosensors produces an electrical signal which corresponds to the amount of light received by that photosensor, wherein the plurality of photosensors comprise signal photosensors for measuring at least one of (i) the light delivered to the sample, and (ii) the scattered light returning from the sample.

Inventors

Koeth, Johannes
KOSLOWSKI, NICOLAS

Assignees

Automotive Coalition for Traffic Safety, Inc.

Dates

Publication Date: 20260506
Application Date: 20200612

Claims (20)

A sample interface device for use in identifying the presence of an analyte in a sample, wherein the sample interface device delivers a plurality of light beams to a sample and receives back scattered light from the sample, the sample interface device comprising: - a substrate; - a low-absorbance injection area carried by the substrate for receiving a plurality of light beams and delivering a portion of the plurality of light beams to the sample; and - a plurality of photosensors carried by the substrate, wherein the plurality of photosensors are disposed outboard of the low-absorbance injection area, and further wherein each of the photosensors produces an electrical signal which corresponds to the amount of light received by that photosensor, wherein the plurality of photosensors comprise signal photosensors for measuring at least one of (i) the light delivered to the sample, and (ii) the scattered light returning from the sample.
A sample interface device according to claim 1, wherein one of the plurality of photosensors comprises a reference photosensor for measuring the light delivered to the sample, and the remainder of the plurality of photosensors comprise signal photosensors for measuring the scattered light returning from the sample, preferably wherein the innermost photosensor comprises the reference photosensor.
A sample interface device according to claim 1, further comprising: a transparent protective cover mounted to the substrate, especially wherein the transparent protective cover comprises: a) a sapphire glass element, and/or b) an opening, and further wherein the diffuser is disposed in the opening.
A sample interface device according to claim 1, wherein the plurality of photosensors comprise photodiodes and/or wherein the sample interface device a) is incorporated in an ergonomic apparatus configured to receive the finger of a user, and/or b) is configured to detect alcohol.
A method for delivering a plurality of light beams to a sample and detecting scattered light returning from the sample, the method comprising: - providing a sample interface device, the sample interface device comprising: - a substrate; - a low-absorbance injection area carried by the substrate for receiving a plurality of light beams and delivering a portion of the plurality of light beams to the sample; and - a plurality of photosensors carried by the substrate, wherein the plurality of photosensors are disposed progressively radially outboard of the low-absorbance injection area, and further wherein each of the photosensors produces an electrical signal which corresponds to the amount of light received by that photosensor, wherein the plurality of photosensors comprise signal photosensors for measuring at least one of (i) the light delivered to the sample, and (ii) the scattered light returning from the sample; - introducing a plurality of light beams into the low-absorbance injection area of the sample interface device so that the plurality of light beams are delivered to the sample; and - using the plurality of photosensors on the sample interface device to detect scattered light returning from the sample.
A method according to claim 5 wherein one of the plurality of photosensors comprises a reference photosensor for measuring the light delivered to the sample, and the remainder of the plurality of photosensors comprise signal photosensors for measuring the scattered light returning from the sample, preferably wherein the innermost photosensor comprises the reference photosensor.
A method according to claim 5, wherein the sample interface device further comprises: - a transparent protective cover mounted to the substrate, especially wherein the transparent protective cover comprises: a) a sapphire glass element, and/or b) an opening, and further wherein the diffuser is disposed in the opening.
A method according to claim 5, wherein the plurality of photosensors comprise photodiodes, and/or wherein the sample interface device a) is incorporated in an ergonomic apparatus configured to receive the finger of a user, and/or b) is configured to detect alcohol.
A sample interface device according to one of claims 1 to 4 as part of a system for the non-invasive measurement of an analyte in a sample, wherein the system comprises: - an illumination unit for generating a plurality of light beams, wherein the plurality of light beams constitute a plurality of different wavelengths; and - a sampling unit for receiving the plurality of light beams from the illumination unit, delivering those light beams to the sample, receiving scattered light back from the sample, and converting the scattered light into corresponding electrical signals for subsequent processing and analyte assessment, wherein the sampling unit comprises the sample interface device.
A system according to claim 9 wherein one of the plurality of photosensors comprises a reference photosensor for measuring the light delivered to the sample, and the remainder of the plurality of photosensors comprise signal photosensors for measuring the scattered light returning from the sample, preferably wherein the innermost photosensor comprises the reference photosensor.
A system according to claim 9 wherein the sample interface device further comprises: - a transparent protective cover mounted to the substrate, especially wherein the transparent protective cover comprises: a) a sapphire glass element, and/or b) an opening, and further wherein the diffuser is disposed in the opening.
A system according to claim 9, wherein the plurality of photosensors comprise photodiodes, and/or wherein the sample interface device a) is incorporated in an ergonomic apparatus configured to receive the finger of a user, and/or b) is configured to detect alcohol.
A method according to one of claims 5 to 8 applicable for detecting an analyte in a sample, the method comprising: - providing a system, wherein the system comprises: - an illumination unit for generating a plurality of light beams, wherein the plurality of light beams constitute a plurality of different wavelengths; and - a sampling unit for receiving the plurality of light beams from the illumination unit, delivering those light beams to the sample, receiving scattered light back from the sample, and converting the scattered light into corresponding electrical signals for subsequent processing and analyte assessment, wherein the sampling unit comprises the sample interface device.
A method according to claim 13, wherein one of the plurality of photosensors comprises a reference photosensor for measuring the light delivered to the sample, and the remainder of the plurality of photosensors comprise signal photosensors for measuring the scattered light returning from the sample, preferably wherein the innermost photosensor comprises the reference photosensor.
A method according to claim 13, wherein the sample interface device further comprises: - a transparent protective cover mounted to the substrate, especially wherein the transparent protective cover comprises: a) a sapphire glass element, and/or b) an opening, and further wherein the diffuser is disposed in the opening.
A method according to claim 13, wherein the plurality of photosensors comprise photodiodes, and/or wherein the sample interface device a) is incorporated in an ergonomic apparatus configured to receive the finger of a user, and/or b) is configured to detect alcohol.
A sample interface device according to claim 1 wherein each of the plurality of photosensors is optically isolated from the others of the plurality of photosensors.
A sample interface device according to claim 2 wherein the reference photosensor receives light only from the low-absorbance injection area, and the signal photosensors receive light only from the sample.
A sample interface device according to claim 2 further comprising: - a diffuser disposed distal to the low-absorbance injection area, wherein the diffuser receives a plurality of light beams and directs those light beams to the reference photosensor.
A sample interface device according to claim 19 further comprising: - a first mask disposed about the perimeter of the diffuser to prevent the light beams from passing to the signal photosensors; and - a second mask disposed between the reference photosensor and the sample, wherein the second mask prevents scattered light from passing from the sample to the reference photosensor.

Description

REFERENCE TO PENDING PRIOR PATENT APPLICATION This patent application claims benefit of pending prior U.S. Provisional Patent Application Serial No. 62/860,413, filed 06/12/2019 by Automotive Coalition for Traffic Safety, Inc. and Johannes Koeth et al. for SYSTEM FOR NON-INVASIVE MEASUREMENT OF AN ANALYTE IN A VEHICLE DRIVER (Attorney's Docket No. ACTS-4 PROV), which patent application is hereby incorporated herein by reference. BACKGROUND The present application generally relates to a system and methods for non-invasively measuring an analyte in a vehicle driver. More specifically, the application relates to a measurement quantitative spectroscopy system for measuring the presence or concentration of an analyte, for example, alcohol, alcohol byproducts, alcohol adducts, or substances of abuse, utilizing non-invasive techniques in combination with multivariate analysis. Current practice for alcohol measurements is based upon either blood measurements or breath testing. Blood measurements define the gold standard for determining alcohol intoxication levels. However, blood measurements require either a venous or capillary sample and involve significant handling precautions in order to minimize health risks. Once extracted, the blood sample must be properly labeled and transported to a clinical laboratory or other suitable location where a clinical gas chromatograph is typically used to measure the blood alcohol level. Due to the invasiveness of the procedure and the amount of sample handling involved, blood alcohol measurements are usually limited to critical situations such as for traffic accidents, violations where the suspect requests this type of test, and accidents where injuries are involved. Because it is less invasive, breath testing is more commonly encountered in the field. In breath testing, the subject must expire air into the instrument for a sufficient time and volume to achieve a stable breath flow that originates from the alveoli deep within the lungs. The device then measures the alcohol content in the air, which is related to blood alcohol through a breath-blood partition coefficient. The blood-breath partition coefficient used in the United States is 2100 (implied units of mg EtOH/dL blood per mg EtOH/dL air) and varies between 1900 and 2400 in other nations. The variability in the partition coefficient is due to the fact that it is highly subject dependent. In other words, each subject will have a partition coefficient in the 1900 to 2400 range that depends on his or her physiology. Since knowledge of each subject's partition coefficient is unavailable in field applications, each nation assumes a single partition coefficient value that is globally applied to all measurements. In the U.S., defendants in DUI cases often use the globally applied partition coefficient as an argument to impede prosecution. Breath measurements have additional limitations. First, the presence of "mouth alcohol" can falsely elevate the breath alcohol measurement. This necessitates a 15-minute waiting period prior to making a measurement in order to ensure that no mouth alcohol is present. For a similar reason, a 15 minute delay is required for individuals who are observed to burp or vomit. A delay of 10 minutes or more is often required between breath measurements to allow the instrument to return to equilibrium with the ambient air and zero alcohol levels. In addition, the accuracy of breath alcohol measurements is sensitive to numerous physiological and environmental factors. Multiple government agencies, and society in general, seek non-invasive alternatives to blood and breath alcohol measurements. Quantitative spectroscopy offers the potential for a completely non-invasive alcohol measurement that is not sensitive to the limitations of the current measurement methodologies. While non-invasive determination of biological attributes by quantitative spectroscopy has been found to be highly desirable, it has been very difficult to accomplish. Attributes of interest include, as examples, analyte presence, analyte concentration (e.g., alcohol concentration), direction of change of an analyte concentration, rate of change of an analyte concentration, disease presence (e.g., alcoholism), disease state, and combinations and subsets thereof. Non-invasive measurements via quantitative spectroscopy are desirable because they are painless, do not require a fluid draw from the body, carry little risk of contamination or infection, do not generate any hazardous waste, and can have short measurement times. Several systems have been proposed for the non-invasive determination of attributes of biological tissue. These systems have included technologies incorporating polarimetry, mid-infrared spectroscopy, Raman spectroscopy, Kromoscopy, fluorescence spectroscopy, nuclear magnetic resonance spectroscopy, radio-frequency spectroscopy, ultrasound, transdermal measurements, photo-acoustic spectroscopy, and near-infrared spectrosco