Transcutaneous organ function measurement

• US 10,264,977 B2
• Filed: 10/20/2014
• Issued: 04/23/2019
• Est. Priority Date: 10/22/2013
• Status: Active Grant

• Current Assignee: MediBeacon Inc.
• Original Assignee: MediBeacon Inc.
• Inventors: Heinrich, Ralf, Pill, Johannes, Neudecker, Sabine, Schock-Kusch, Daniel, Guenther, Juergen, Koenig, Stefan, Friedmann, Jochen
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Liu, Chu Chuan (JJ)
• Application Number:
  US15/030,727
• Publication Number:
  US 20160249808A1
• Time in Patent Office: 1,646 Days
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/201 Assessing renal or kidney functions

Abstract

Disclosed herein is a method for the transcutaneous determination of organ function in a subject. The method includes administering a fluorescent indicator substance to the subject, determining a first and a second concentration-time curve of the fluorescent indicator in a body fluid of the patient and fitting the concentration-time curves to a four compartment kinetic model.

Claims

1. A method for determining an organ function in a subject, the method comprising:

a) administering a fluorescent indicator compound to the bloodstream of the subject;

b) measuring transcutaneously a first concentration-time curve in a first body fluid at a first position on the subject, wherein said first concentration-time curve comprises (i) at least one data point collected prior to administering the fluorescent indicator compound to the bloodstream of the subject as a first background time point, and (ii) at least five data points collected after administering the fluorescent indicator compound to the subject;

c) measuring transcutaneously a second concentration-time curve in a second body fluid at a second position on the subject, wherein said second concentration-time curve comprises (i) at least one data point collected prior to administering the fluorescent indicator compound to the bloodstream of the subject as a second background time point, and (ii) at least five data points collected after administering the fluorescent indicator compound to the subject;

d) fitting the first and the second concentration-time curves into a kinetic model representing at least four diffusion compartments, wherein the diffusion compartments comprise plasma, interstitial fluid, local interstitium at the position of the measuring, and distribution; and

e) determining the organ function of the subject based on the results of fitting the first concentration-time curve and the second concentration-time curve into the kinetic model;

wherein the first position and the second position on the body of the subject are different,

the first body fluid and the second body fluid of the subject may be the same or different, and

measuring fluorescence of the indicator compound at the first position and the second position is performed simultaneously.

2. The method of claim 1, wherein said kinetic model is a kinetic model representing four diffusion compartments.

3. The method of claim 1, wherein the organ function is the glomerular filtration rate (GFR).

4. The method of claim 1, wherein the result of said fitting is the GFR per plasma volume of said subject.

5. The method of claim 4, wherein a numeric value assigned to the total plasma volume of said subject is determined from a body mass of said subject.

6. The method of claim 1, wherein at least at least one of the data points for the first concentration-time curve and at least one of the data points for the second concentration-time curve is collected within two hours or less after administering the fluorescent indicator compound to the subject.

7. The method of claim 1, wherein the indicator compound comprises a fluorescent low-molecular weight compound covalently bound to a hydrophilic compound, wherein the hydrophilic part is selected from the list consisting of oligo- and polysaccharides, oligo- and polyalcohols, and oligo- and polyethers.

8. A device configured to implement the method of claim 1, said device comprising:

a) a first sensor for transcutaneously measuring fluorescence of the indicator compound at the first position,

b) a second sensor for transcutaneously measuring fluorescence of the indicator compound at the second position; and

c) a data processing unit for fitting the values obtained by the sensors into the kinetic model, wherein said first sensor and said second sensor are operatively linked in that the data processing unit of the device is configured to bring together the results of the measurements performed by said sensors and fits the data into the kinetic model.

9. The device of claim 8, further comprising a data storage unit comprising at least reference values of total plasma volume correlated to body mass.

10. A kit comprising the device of claim 8 and the fluorescent indicator compound.

11. The kit of claim 10, wherein the indicator compound comprises a fluorescent low-molecular weight compound covalently bound to a hydrophilic compound, wherein the hydrophilic part is selected from the list consisting of oligo- and polysaccharides, oligo- and polyalcohols, and oligo- and polyethers.

12. A non-transitory computer readable medium comprising an executable computer program configured to perform the method according to claim 1, while the program is being executed on a computer.

13. A computer or computer network comprising at least one processor, wherein the computer or computer network is configured to perform the method according to claim 1.