Analyte system and method for determining hemoglobin parameters in whole blood
Inventors
Cafferty, Michael S. • Cionek, Scott P.
Assignees
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Publication Number
US-10337980-B2
Publication Date
2019-07-02
Expiration Date
Abstract
A replaceable cuvette assembly for use in an optical absorbance measurement system for measuring whole-blood hemoglobin parameters or whole-blood bilirubin parameters. The replaceable cuvette assembly includes a cuvette substrate and a cuvette module fixedly connected to the cuvette substrate wherein the cuvette substrate is a support for securing the cuvette assembly within the optical absorbance measurement system. The cuvette module has a sample inlet port, a sample outlet port, an electronic chip assembly, a sample receiving chamber that fluidly communicates with the sample inlet port and the sample outlet port, a first cuvette window, and a second cuvette window forming a portion of the sample receiving chamber. The first cuvette window and the second cuvette window are aligned with each other defining a cuvette optical path length between the first cuvette window and the second cuvette window and disposed within an optical path of the optical absorbance measurement system.
Core Innovation
The invention provides a replaceable cuvette assembly configured for installation in an optical absorbance measurement system for measuring whole-blood hemoglobin parameters or whole-blood bilirubin parameters. The cuvette assembly includes a cuvette substrate and a cuvette module fixedly connected to the cuvette substrate, and the cuvette module forms a sample receiving chamber that fluidly communicates with a sample inlet port and a sample outlet port.
The cuvette module includes a first cuvette window and a second cuvette window disposed in an optical path of the optical absorbance measurement system and aligned with each other to define a cuvette optical path length between the first cuvette window and the second cuvette window. The cuvette module includes a cuvette first portion and a cuvette second portion bonded to each other to form the sample receiving chamber, with the windows located in respective portions, and the defined optical path length is measured and stored in an electronic chip.
The optical absorbance measurement system includes an LED light source with a circular polarizer and paired diffusers to control spatial-light-distribution errors associated with whole-blood diffuse transmittance. The system uses a prism-based spectrometer with minimized stray light, a calibrating light module providing known wavelengths for wavelength-scale recalibration, and thermal-compensating structures that maintain slit-image position on a light-array detector.
Claims Coverage
The claims coverage centers on one independent claim and dependent refinements, with eight inventive features covering the replaceable cuvette assembly and related optical and mechanical structures.
Replaceable cuvette assembly installed in optical absorbance measurement system
A replaceable cuvette assembly capable of installation in an optical absorbance measurement system for measuring whole-blood hemoglobin parameters or whole-blood bilirubin parameters, including a cuvette substrate and a cuvette module fixedly connected to the cuvette substrate.
Aligned first and second cuvette windows defining cuvette optical path length
The cuvette module having a first cuvette window and a second cuvette window aligned with each other thereby defining a cuvette optical path length between the first cuvette window and the second cuvette window, with the first cuvette window and the second cuvette window disposed within an optical path of the optical absorbance measurement system.
Sample receiving chamber with inlet and outlet ports
The cuvette module including a sample inlet port and a sample outlet port, and a sample receiving chamber that fluidly communicates with the sample inlet port and the sample outlet port, where the sample receiving chamber is formed by bonded cuvette first and second portions.
Bonded cuvette first and second portions forming sample receiving chamber
The cuvette module includes a cuvette first portion and a cuvette second portion bonded to each other and thereby form the sample receiving chamber.
Cuvette substrate with light-path opening disposed within optical path
The cuvette substrate has a cuvette light path opening disposed within the optical path.
Electronic chip handling of defined cuvette optical path length
The cuvette assembly provides for accurately measuring and storing the defined cuvette optical path length in an electronic chip.
Partitioned cuvette first and second portions with enumerated internal components
A cuvette first portion containing a sample receiving recess, the sample inlet port, the sample outlet port, the electronic chip assembly, and the first cuvette window, and a cuvette second portion containing the second cuvette window.
Raised, water-tight sealing window feature
A second cuvette window of the cuvette second portion that is a raised surface forming a water-tight seal around a sample receiving recess of the cuvette first portion.
The claims focus on a replaceable cuvette assembly with aligned first and second cuvette windows that define a cuvette optical path length in the optical path, a sample receiving chamber with inlet and outlet ports formed by bonded cuvette portions, and refinements including a cuvette light-path opening, electronic chip measurement and storage of the optical path length, and mechanical sealing features.
Stated Advantages
Correlation results greater than 99% between whole-blood and reference lysed-analyzer analyte values.
Documented Applications
Measuring whole-blood hemoglobin parameters and whole-blood bilirubin using an optical absorbance measurement system with the replaceable cuvette assembly.
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