Transcutaneous organ function measurement
Inventors
Heinrich, Ralf • Pill, Johannes • NEUDECKER, Sabine • Schock-Kusch, Daniel • Guenther, Juergen • Koenig, Stefan • Friedemann, Jochen
Assignees
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Publication Number
US-12257027-B2
Publication Date
2025-03-25
Expiration Date
Abstract
The present invention relates to a method for determining an organ function in a subject, comprising the steps of: providing a first concentration-time curve obtained by transcutaneously measuring in a body fluid at a first position background fluorescence in at least one first time point and fluorescence of an indicator compound in at least a second, a third, a fourth, a fifth, and a sixth time point; providing a second concentration curve obtained by transcutaneously measuring in a body fluid at a second position background fluorescence in at least one seventh time point and fluorescence of an indicator compound in at least a eighth, a ninth, a tenth, an eleventh, and a twelfth time point; fitting the first and the second concentration curve into a kinetic model representing at least four diffusion compartments; and thereby determining an organ function in a subject. The invention further relates to a device for determining an organ function according to the method of the present invention, said device comprising a first sensor for transcutaneously measuring fluorescence of an indicator at a first position, a second sensor for transcutaneously measuring fluorescence of an indicator at a second position; and a data processing unit for fitting the values obtained by the sensors into a kinetic model of one of the preceding claims. The present invention also relates to a kit comprising a device of the present invention and an indicator compound, as well as to a computer or computer network comprising at least one processor, wherein the computer or computer network is adapted to perform the method according to the present invention.
Core Innovation
The invention provides a device configured to determine an organ function in a subject by transcutaneously measuring fluorescence. A first sensor detects photons emitted by an indicator compound in a first body fluid at a first position on the subject and transcutaneously measures a first concentration-time curve in the first body fluid. A second sensor detects photons emitted by the indicator compound in a second body fluid at a second position on the subject and transcutaneously measures a second concentration-time curve in the second body fluid.
The device combines the first and second concentration-time curves and fits values associated with the curves into a kinetic model to determine the organ function. The kinetic model represents diffusion compartments and includes compartments selected from plasma, interstitial fluid, local interstitium at the position of measuring, and distribution. The first and second body fluids may be the same or different, and the data processing unit brings together results from the first and second transcutaneous measurements and fits them into the kinetic model.
The method includes administering a fluorescent indicator compound, detecting first and second photon sets emitted by the compound in a body fluid at first and second positions, and transcutaneously measuring first and second concentration-time curves. Each concentration-time curve includes background time points prior to administering and post-administering data points. The first concentration-time curve, the second concentration-time curve, and the measured concentration of the fluorescent indicator compound in the body fluid are fitted into a kinetic model representing two or three or four diffusion compartments to determine the organ function.
Claims Coverage
Two independent claims are identified: one device claim and one method claim. The independent claims share the core inventive concept of transcutaneous photon detection at two positions, forming concentration-time curves, and fitting the results into a kinetic diffusion-compartment model to determine an organ function.
Dual transcutaneous concentration-time curve measurement with two sensors
A device with a first sensor and a second sensor that each detects photons emitted by an indicator compound in a body fluid at respective positions and transcutaneously measures a respective concentration-time curve in the body fluid.
Kinetic model fitting of first and second concentration-time curves to determine organ function
A data processing unit configured to fit values associated with the first and second concentration-time curves into a kinetic model, bringing together results of the transcutaneous measurements performed by the first sensor and the second sensor to determine the organ function.
Simultaneous dual-position transcutaneous concentration-time curves with background and post-admin data points
A method in which, after administering a fluorescent indicator compound, a first set of photons is detected at a first position and transcutaneously measured to obtain a first concentration-time curve comprising background time points prior to administering and at least five data points after administering; and a second set of photons is detected at a second position and transcutaneously measured simultaneously to obtain a second concentration-time curve comprising background time points prior to administering and at least five data points after administering.
Kinetic diffusion-compartment model fitting to determine organ function using first and second concentration-time curves and measured concentration
Fitting the first concentration-time curve, the second concentration-time curve, and the concentration of the fluorescent indicator compound in the body fluid within a time frame of the first and second transcutaneous measurements into a kinetic model representing two or three or four diffusion compartments selected from plasma, interstitial fluid, local interstitium at the position of measuring, and distribution to determine the organ function.
Across both independent claims, the inventive coverage centers on obtaining two transcutaneous concentration-time curves from photons emitted by a fluorescent indicator compound at two positions, and fitting both curves and the measured indicator concentration into a kinetic diffusion-compartment model with selected diffusion compartments to determine the organ function.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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