METHOD AND APPARATUS FOR EVALUATING VALUES REPRESENTING A MASS OR A CONCENTRATION OF A SUBSTANCE PRESENT WITHIN THE BODY OF A PATIENT

• US 20130018245A1
• Filed: 09/07/2010
• Published: 01/17/2013
• Est. Priority Date: 09/09/2009
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA)
• Inventors: Chamney, Paul, Moissl, Ulrich, Wabel, Peter, Nier, Volker, Wieskotten, Sebastian
• Granted Patent: US 9,301,716 B2
• Time in Patent Office: Days
• US Class Current: 600/368
• 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 fulfils a criterion. The present invention further relates to systems and computer programs for performing this method.

Claims

1-27. -27. (canceled)

28. A method for evaluating a value representing a mass or a concentration or a volume of a substance comprised by a tissue or a bodily fluid of a patient, comprising the steps of:

determining a relation between one or more calculated or measured value(s) reflecting the mass or the concentration or the volume of the substance comprised by the tissue or the bodily fluid and reflecting a distribution space of the patient or an approximation thereof, and

assessing whether the relation fulfils at least one criterion.

29. The method according to claim 28, wherein the at least one value 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.

30. The method according to claim 28, wherein the substance is selected from the group consisting of proteins produced naturally in the body of the patient, hemoglobin, albumin, insulin, glucose, CRP, and pharmaceutically-effective non-endogeneous substances.

31. The method according to claim 28, wherein the mass or the concentration of the substance or changes thereof is an indicator of the anemia state of the patient.

32. The method according to claim 31, 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 mass of hemoglobin over time, a hematocrit, and a change in hematocrit over time.

33. The method according to claim 28, wherein the distribution space of the patient is selected from the group consisting of a measured value of the blood volume, a calculated value of the blood volume, an approximation based on measured values reflecting the relative overhydration of the patient, and an approximation based on calculated values reflecting the relative overhydration of the patient.

34. The method according to claim 28, wherein the distribution space is measured or approximated before dialysis or based on pre-dialysis values of the patient, or is measured or approximated during or after dialysis treatment.

35. The method according to claim 28, further comprising the step of defining a target range in a diagram reflecting the mass or the concentration of the substance and the distribution space or the approximation thereof.

36. The method according to claim 35, further comprising the step of calculating a regression line based on either measured or calculated values each both the mass or the concentration of the substance comprised by the tissue or a bodily fluid and a distribution space of the patient or an approximation thereof, and determining any overlap between the regression line and the target range.

37. The method according to claim 28, further comprising the step of calculating and/or measuring parameters reflecting the mass or the concentration of the substance and/or the distribution space of the patient or an approximation thereof.

38. The method according to claim 28, further comprising the step of determining or adjusting a dosage of a medicament to be administered to a patient for improving the anemia state of the patient based on the obtained relation between calculated or measured value(s) and the criterion.

39. The method according to claim 28, further comprising the step of determining the criterion.

40. A system for evaluating a value representing a mass or a concentration or a volume of a substance comprised by 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 the mass or the concentration or the volume of the substance comprised by the tissue or the bodily fluid and reflecting a distribution space of the patient or an approximation thereof, and

assess whether the relation fulfils at least one criterion.

41. The system according to claim 40, further comprising a system for obtaining a value reflecting a characteristic selected from the group consisting of the distribution space of the patient'"'"'s body, an 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.

42. The system according to claim 41, wherein the system for obtaining a value comprises a device for measuring or calculating the hydration state or a degree of overhydration of the patient.

43. The system according to claim 41, wherein the system for obtaining a value comprises a device selected from the group consisting of a device for measuring weight, a device for determining the blood volume of the patient, a keyboard, a touch screen, and a device for measuring or calculating the concentration, the volume and/or the mass of the substance.

44. The system according to claim 40, further comprising an output device for outputting results provided by the controller.

45. The system according to claim 40, wherein the system is configured to treat a patient'"'"'s blood.

46. The system according to claim 45, wherein the system is configured to treat the patient'"'"'s blood by dialysis.

47. The system according to claim 46, wherein the system is configured to treat the patient'"'"'s blood by hemofiltration, ultrafiltration, and/or hemodialysis.

48. 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 comprised by a tissue or a bodily fluid of a patient:

determining a relation between one or more calculated or measured value(s) reflecting the mass or the concentration or the volume of the substance comprised by the tissue or the bodily fluid and reflecting a distribution space of the patient or an approximation thereof, and

assessing whether the relation fulfils at least one criterion.