Method and apparatus for evaluating values representing a mass or a concentration of a substance present within the body of a patient

• US 9,301,716 B2
• Filed: 09/07/2010
• Issued: 04/05/2016
• Est. Priority Date: 09/09/2009
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Inventors: Chamney, Paul, Moissl, Ulrich, Wabel, Peter, Nier, Volker, Wieskotten, Sebastian, Velasco, Nestor
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): WESTON, TIFFANY C
• Application Number:
  US13/394,997
• Publication Number:
  US 20130018245A1
• Time in Patent Office: 2,037 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: G01N 33/483 Physical analysis of biological material

Abstract

The present invention relates to a method for evaluating a value representing the mass or the concentration of a substance comprised by a tissue or a bodily fluid of a patient, the method including the steps of a) determining a relation between one or more calculated or measured value(s) reflecting the mass or the concentration and a distribution space of the patient or an approximation thereof, and b) assessing whether the relation fulfills a criterion. The present invention further relates to systems and computer programs for performing this method.

Claims

1. A method for evaluating a value representing a mass or a concentration or a volume of a substance contained in a tissue or a bodily fluid of a patient, comprising the steps of:

determining, by a processor, a relation between one or more calculated or measured value(s) reflecting;

(a) the mass or the concentration or the volume of the substance contained in the tissue or the bodily fluid of the patient or an approximation thereof, and

(b) a distribution space of the patient or an approximation thereof, the distribution space being a body fluid, a body tissue, a body weight, a total body mass, a combination of the body fluid and the body tissue, or a space of the patient, wherein the distribution space is based on calculated or measured values reflecting a relative overhydration (relOH) of the patient or an absolute overhydration (OH) of the patient;

assessing, by the processor, whether the relation fulfils at least one criterion; and

determining or adjusting a dosage of a medicament to be administered to the patient based on the assessing whether the relation fulfills the at least one criterion,

wherein the dosage of the medicament is administered to the patient for improving an anemia state of the patient.

2. The method according to claim 1, wherein the one or more calculated or measured value(s) reflecting the mass, the volume or the concentration of the substance was obtained from a sample selected from the group consisting of blood samples, urine samples, and tissue samples.

3. The method according to claim 1, wherein the substance is selected from the group consisting of proteins produced naturally in the body of the patient, hemoglobin, albumin, insulin, glucose, C-reactive protein (CRP), and pharmaceutically-effective non-endogeneous substances.

4. The method according to claim 1, wherein the mass or the concentration of the substance or changes thereof is an indicator of an anemia state of the patient.

5. The method according to claim 4, wherein the indicator of the anemia state of the patient is selected from the group consisting of a concentration of hemoglobin, a total mass of hemoglobin, a change in the concentration or in the total mass of hemoglobin over time, a hematocrit, and a change in the hematocrit over time.

6. The method according to claim 1, wherein the distribution space of the patient is selected from a measured value of a blood volume or a calculated value of the blood volume.

7. The method according to claim 1, wherein the distribution space is measured or approximated before a dialysis treatment or based on pre-dialysis values of the patient.

8. The method according to claim 1, further comprising the step of:

defining a target range in a diagram reflecting (a) the mass or the concentration of the substance or the approximation thereof and (b) the distribution space or the approximation thereof.

9. The method according to claim 8, further comprising the step of:

calculating a regression line based on either the measured or the calculated values reflecting both (a) the mass or the concentration of the substance or an approximation thereof, and (b) the distribution space of the patient or an approximation thereof; and

determining any overlap between the regression line and the target range.

10. The method according to claim 1, further comprising the step of:

at least one of calculating or measuring the values reflecting at least one of (a) the mass or the concentration of the substance or an approximation thereof or (b) the distribution space of the patient or an approximation thereof.

11. The method according to claim 1, further comprising the step of:

determining the at least one criterion.

12. The method according to claim 1, wherein the distribution space is measured or approximated during or after a dialysis treatment.

13. A system for evaluating a value representing a mass or a concentration or a volume of a substance contained in a tissue or a bodily fluid of a patient, comprising a controller configured to:

determine a relation between one or more calculated or measured value(s) reflecting;

(a) the mass or the concentration or the volume of the substance contained in the tissue or the bodily fluid of the patient or an approximation thereof, and

(b) a distribution space of the patient or an approximation thereof, the distribution space being a body fluid, a body tissue, a body weight, a total body mass, a combination of the body fluid and the body tissue, or a space of the patient, wherein the distribution space is based on calculated or measured values reflecting a relative overhydration (relOH) of the patient or an absolute overhydration (OH) of the patient;

assess whether the relation fulfils at least one criterion; and

determine or adjust a dosage of a medicament to be administered to the patient based on the assessing whether the relation fulfills the at least one criterion,

wherein the dosage of the medicament is administered to the patient for improving an anemia state of the patient.

14. The system according to claim 13, further comprising:

a system configured to obtain a value reflecting a characteristic selected from the group consisting of the distribution space of the patient'"'"'s body, the approximation of the distribution space of the patient'"'"'s body, changes in the distribution space of the patient'"'"'s body, the mass of the substance, changes in the mass of the substance, the volume of the substance, changes in the volume of the substance, the concentration of the substance, and changes in the concentration of the substance.

15. The system according to claim 14, wherein the system configured to obtain the value comprises a device configured to measure or calculate a hydration state or a degree of overhydration of the patient.

16. The system according to claim 14, wherein the system configured to obtain the value comprises a device selected from the group consisting of a device configured to measure weight, a device for configured to determine a blood volume of the patient, a keyboard, a touch screen, and a device configured to measure or calculate at least one of the concentration, the volume or the mass of the substance.

17. The system according to claim 13, further comprising:

an output device configured to output results provided by the controller.

18. The system according to claim 13, wherein the system is configured to treat a patient'"'"'s blood.

19. The system according to claim 18, wherein the system is configured to treat the patient'"'"'s blood by dialysis.

20. The system according to claim 19, wherein the system is configured to treat the patient'"'"'s blood by at least one of hemofiltration, ultrafiltration, or hemodialysis.

21. A non-transitory computer-readable medium with an executable program stored thereon, wherein the program instructs a programmable computer system to perform the following steps for evaluating a value representing a mass or a concentration or a volume of a substance contained in a tissue or a bodily fluid of a patient:

determining a relation between one or more calculated or measured value(s) reflecting;

(a) the mass or the concentration or the volume of the substance contained in the tissue or the bodily fluid of the patient or an approximation thereof, and

(b) a distribution space of the patient or an approximation thereof, the distribution space being a body fluid, a body tissue, a body weight, a total body mass, a combination of the body fluid and the body tissue, or a space of the patient, wherein the distribution space is based on calculated or measured values reflecting a relative overhydration (relOH) of the patient or an absolute overhydration (OH) of the patient;

assessing whether the relation fulfils at least one criterion; and

determining or adjust a dosage of a medicament to be administered to the patient based on the assessing whether the relation fulfills the at least one criterion,

wherein the dosage of the medicament is administered to the patient for improving an anemia state of the patient.