Analyte system and method for determining hemoglobin parameters in whole blood

Inventors

Cafferty, Michael S.Cionek, Scott P.

Assignees

Nova Biomedical Corp

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Publication Number

US-10732038-B2

Patent

Publication Date

2020-08-04

Expiration Date


Abstract

A light-emitting module for use in a system for measuring whole-blood hemoglobin parameters or whole-blood bilirubin parameters. The light-emitting module includes an LED light source capable of emitting light wherein the light is directed thereby defining an optical path and a plurality of optical components. The plurality of optical components includes a collimating lens, a first optical diffuser, a circular polarizer, and a focusing lens wherein the plurality of optical components is disposed within the optical path of the light from the LED light source.

Core Innovation

The invention relates to a CO-oximeter/whole-blood absorbance spectroscopy system that measures whole-blood hemoglobin parameters and/or whole-blood bilirubin. The system includes a light-emitting module with an LED light source defining an optical path, and an optical train sequentially disposed within the optical path upstream of a sample module, including a collimating lens, a first optical diffuser, a circular polarizer, and a focusing lens.

A key aspect is the use of circularly polarized light to reduce hemoglobin absorbance error, together with system-level optical features that address stray light and whole-blood scattering. Dual diffusers around a cuvette provide spatial-light distribution matching, and prism-based low-stray-light spectroscopy is implemented with an expanded wavelength range and resolution selection.

The system further includes a calibrating-light module for wavelength calibration and thermal-compensating means for prism refractive shifts to support stable prism-based spectroscopy. In model development, a KOPLS/kernel-based orthogonal projection mapping model is described using manipulated blood samples, reporting strong correlation between whole-blood and lysed-reference analyte values including tHb, O2Hb, COHb, HHb, MetHb, and whole-blood bilirubin (tBil).

Claims Coverage

The provided independent claims focus on an LED-based light-emitting module integrated into an absorbance spectroscopy system for measuring whole-blood hemoglobin parameters and/or whole-blood bilirubin parameters. Across the independent claims, the inventive scope centers on the optical train and, in one independent claim, a system integration relationship that includes a calibrating-light module positioned between the optical sample module and a spectrometer module.

LED optical path with sequential diffuser and circular polarizer

A light-emitting module integrated with a system for measuring whole-blood hemoglobin parameters or whole-blood bilirubin parameters with absorbance spectroscopy, wherein an LED light source defines an optical path and a plurality of optical components sequentially disposed within the optical path comprises a collimating lens, a first optical diffuser, a circular polarizer, and a focusing lens, disposed upstream of a sample module.

Separate sample module with calibrating-light module between sample and spectrometer

A light-emitting module capable of installing in a system for measuring whole-blood hemoglobin parameters or whole-blood bilirubin parameters with absorbance spectroscopy, wherein the system includes a calibrating-light module, a spectrometer module, and an optical sample module containing a whole-blood sample distinct from the light-emitting module; the light-emitting module directs light through the optical sample module and the calibrating-light module disposed within the optical path between the optical sample module and the spectrometer module receives the light.

Taken together, the independent claims define an LED-based light-emitting module with a sequential optical train including a collimating lens, first optical diffuser, circular polarizer, and focusing lens arranged in the optical path upstream of the sample module, and further define system integration where light passes through a distinct optical sample module while a calibrating-light module is positioned between the optical sample module and the spectrometer module.

Stated Advantages

Circular polarization reduces hemoglobin absorbance error.

System-level optical features address stray light and whole-blood scattering.

Prism-based low-stray-light spectroscopy provides an expanded wavelength range and resolution selection.

Thermal-compensating means provide compensation for prism refractive shifts.

KOPLS/kernel-based orthogonal projection mapping is reported to show >99% correlation between whole-blood and lysed-reference analyte values including tHb, O2Hb, COHb, HHb, MetHb, and tBil.

Documented Applications

Measuring whole-blood hemoglobin parameters using absorbance spectroscopy.

Measuring whole-blood bilirubin (tBil) using absorbance spectroscopy.

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