Method and apparatus for non-invasively measuring blood circulatory hemoglobin
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Publication Number
US-12228507-B2
Publication Date
2025-02-18
Expiration Date
Abstract
A method and apparatus of non-invasively determining a blood circulatory hemoglobin value for a subject using a near-infrared spectrophotometric (NIRS) sensing device is provided. The method includes: a) non-invasively sensing tissue of the subject using the NIRS sensing device at about a time T1, and determining at least one NIRS tissue totalHb value; b) acquiring at least one circulatory blood sample from the subject at about the time T1; c) determining at least one blood circulatory THb value; d) calibrating the NIRS sensing device using the at least one blood circulatory THb value and the at least one MRS tissue TotalHb value; and e) determining at least one blood circulatory hemoglobin value using the calibrated NIRS sensing device and the at least one NIRS tissue totalHb value.
Core Innovation
The invention describes NIRS methods, a sensing device, and software for determining a blood circulatory hemoglobin value from non-invasive tissue total hemoglobin measurements. The NIRS sensing device is calibrated using a blood circulatory THb value representative of the subject's blood during the measurement period and stored empirical data that includes an empirical circulatory THb calibration slope. After calibration, subsequent NIRS tissue totalHb values are used to determine blood circulatory hemoglobin values.
The described calibration includes a single-point approach using a stored empirical slope and a subject calibration intercept, and a multi-point approach using measurements associated with different points in time to derive subject-specific calibration parameters. The supplied content does not include the background section, so the problem identified there is not explicitly described in patent. The content states that subsequent measurements can provide real-time circulatory THb values without additional blood samples.
Claims Coverage
The relevant claims identify four independent claims: two methods, a NIRS sensing device, and a non-transitory computer readable medium. Their claim elements cover tissue sensing, calibration using blood circulatory THb and NIRS tissue totalHb values, and determination of a subsequent blood circulatory hemoglobin value.
Single-point NIRS method using stored empirical data
The method senses tissue non-invasively, inputs at least one blood circulatory THb value, and self-calibrates using that value, a NIRS tissue totalHb value, and stored empirical data including an empirical circulatory THb calibration slope. The calibrated device determines a blood circulatory hemoglobin value from a subsequent NIRS tissue totalHb value.
Multi-point NIRS method
The method uses plural NIRS tissue totalHb values and plural blood circulatory THb values, each associated with respective different points in time during a period. The device self-calibrates using at least one of each value and determines a blood circulatory hemoglobin value from a subsequent NIRS tissue totalHb value.
NIRS sensing device with processor-based calibration
The device includes a transducer portion with a light source and light detector, and a processor portion with stored instructions. The processor senses tissue non-invasively, calibrates using NIRS tissue TotalHb and blood circulatory THb values with stored empirical data, determines a subject calibration intercept using the empirical circulatory THb calibration slope, and determines a value from subsequent NIRS tissue totalHb.
Software for calibrating a NIRS sensing device
The non-transitory computer readable medium contains software code sections that control a NIRS sensing device to sense tissue, receive a blood circulatory THb value, and calibrate using that value, a NIRS tissue TotalHb value, and stored empirical data including an empirical circulatory THb calibration slope. The software determines a blood circulatory hemoglobin value using a subsequent NIRS tissue totalHb value.
The claims cover method, device, and software forms of NIRS-based blood circulatory hemoglobin determination. The central claim elements are non-invasive tissue sensing, calibration against blood circulatory THb using empirical data, and use of subsequent tissue measurements to determine the blood circulatory hemoglobin value.
Stated Advantages
Once calibrated, the device can provide subsequent blood circulatory THb measurements without additional blood samples.
The supplied content describes subsequent blood circulatory THb measurements as real-time.
Documented Applications
Non-invasive determination of a subject's blood circulatory hemoglobin value using NIRS tissue measurements.
Sensing cerebral tissue, including portions of the left and right brain hemispheres using NIRS transducers.
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