Method for calibrating a bioimpedance measuring device, and medical devices

Patent metadata

Field	Value
Publication number	US-11701022-B2
Application number	US-202016734921-A
Country	US
Kind code	B2
Filing date	Jan 6, 2020
Priority date	Jan 6, 2020
Publication date	Jul 18, 2023
Grant date	Jul 18, 2023

Abstract

The disclosure relates to new methods for calibrating or adjusting a bioimpedance measuring device. Furthermore, the present disclosure relates to a medical set or system, a medical measuring standard, a method for testing a bioimpedance measuring device, and a bioimpedance measuring device.

First claim

The invention claimed is:

1. A method for calibrating a bioimpedance measuring device, the method comprising the steps:
providing the bioimpedance measuring device;
providing a measuring standard with a plurality of components (X, Y, Z), that may each be adjusted in terms of their respective component value (x1, x2, . . . xm; yi, y2, . . . y; zi, z, . . . zo), so that a number |K| of combinations of component values may be set, wherein |K|=m*n*o;
providing a Patient Database with a number |PDB| combinations of information, wherein each of the combinations of information comprises:
a) one or more patient parameters that characterize a specific patient, wherein the one or more patient parameters are not bioimpedance measurement results; and
b) a plurality of bioimpedance measurement results of the specific patient from at least one previous bioimpedance measurement process of the specific patient measured over a frequency range;

determining a number |CDB| of the combinations of component values based on which the plurality of bioimpedance measurement results of at least a predetermined part of the number |PDB| of combinations of the information may be gained using Cole Models or Cole-Cole Plots, wherein the number |CDB| is less than the number |K|;
providing a Calibration Database or Pool comprising the determined number |CDB| of the combinations of component values; and
calibrating the bioimpedance measuring device by using the measuring standard and adjusting the plurality of components (X, Y, Z) to some or all of the number |CDB| of the combinations of component values from the Calibration Database or Pool, but not by adjusting the plurality of components (X, Y, Z) to more than the number |CDB| of the combinations of component values.

2. The method according to claim 1 , further comprising: filtering the Patient Database according to predetermined criteria in order to create the Calibration Database or Pool based on the Patient Database, wherein in order to create the Calibration, Database or Pool, only the number |CDB| of the combinations of component values thus filtered out of the Patient Database are used.

3. The method according to claim 2 , wherein the predetermined criteria includes patient age, race, height, weight, or gender.

4. The method according to claim 1 , wherein the calibrating the bioimpedance measuring device is carried out repeatedly at different points of time.

5. The method according to claim 4 , wherein calibration results determined when carrying out the steps of calibrating performed at the different points of time, respectively, are compared to each other and deviations from each other are determined.

6. The method according to claim 1 , wherein the calibrating the bioimpedance measuring device comprises connecting measuring electrodes and signal electrodes of the bioimpedance measuring device to contacts of the measuring standard.

7. The method according to claim 6 , wherein the calibrating the bioimpedance measuring device starts automatically when the measuring electrodes and the signal electrodes of the bioimpedance measuring devices have been connected to the contacts of the measuring standard.

8. The method according to claim 6 , wherein the calibrating the bioimpedance measuring device starts after the measuring electrodes and the signal electrodes of the bioimpedance measuring device have been connected to the contacts of the measuring standard and a time condition is met.

9. The method according to any claim 1 , further comprising:
determining a prevailing temperature by a temperature sensor to which at least one of the bioimpedance measuring device and the measuring standard is exposed during the calibration; and
taking into account the determined prevailing temperature during the calibrating the bioimpedance measuring device.

10. The method according to claim 1 , wherein the calibrating the bioimpedance measuring device is performed by a manufacturer of the bioimpedance measuring device.

11. The method according to claim 1 , further comprising:
establishing a signal communication between the measuring standard and at least one of the Calibration Database or Pool and the Patient Database; and
reading the Calibration Database or Pool by the measuring standard.

12. The method according to claim 1 , further comprising:
updating, or automatically updating, at least one of the Calibration Database or Pool and the Patient Database.

13. A medical set, comprising:
a bioimpedance measuring device;
a measuring standard with a plurality of components (X, Y, Z) that may each be adjusted in terms of their respective component value (x1, x2, . . . xm; y1, y2, . . . yn; z1, z2, . . . zo), so that a number |k| of combinations of component values may be set, wherein |k|=m*n*o;
a Calibration Database or Pool comprising a number |CDB| of the combinations of component values, wherein the number |CDB| is smaller than the number |K|;
a control unit programmed for calibrating the bioimpedance measuring device by using the measuring standard and setting the plurality of components (X, Y, Z) to some or all of the number |CDB| of the combinations of component values from the Calibration Database or Pool, but not by setting more than the number |CDB| combinations of component values; and
a Patient Database having a number |PDB| combinations of information, wherein each of the combinations of information comprises:
a) one or more patient parameters that characterize a specific patient, wherein the one or more patient parameters are not bioimpedance measuring results; and
b) a plurality of bioimpedance measurement results of the specific patient from at least one previous bioimpedance measurement process of the specific patient measured over a frequency range;

wherein the control unit is programmed for: determining the number |CDB| of the combinations of component values based on which the bioimpedance measuring results of at least a predetermined part of the number |PDB| combinations of information may be gained using Cole Models or Cole-Cole Plots; and
establishing or creating the Calibration Database or Pool comprises the determined number CDB| of the combinations of component values.

14. The medical set according to claim 13 , wherein the control unit is programmed for: filtering the Patient Database according to predetermined criteria in order to create the Calibration Database or Pool from the Patient Database, wherein in order to create the Calibration Database or Pool, only the number |CDB| of the combinations of component values thus filtered out of the Patient Database are used.

15. The medical set according to claim 14 , wherein the predetermined criteria includes patient age, race, height, weight, or gender.

16. The medical set according to claim 13 , wherein the control unit is programmed for comparing calibration results determined when performing the calibrating at different points of time, respectively, to each other and determining deviations from each other.

17. The medical set according to claim 13 , wherein the control unit is programmed for automatically performing the calibrating when measuring electrodes and signal electrodes of the bioimpedance measuring devices have been connected to contacts of the measuring standard.

18. The medical set according to claim 13 , wherein the control unit is programmed for performing the calibrating after measuring electrodes and signal electrodes of the bioimpedance measuring device have been connected to contacts of the measuring standard and a time condition is met.

Assignees

• Fresenius Medical Care Deutschland Gmbh

Inventors

• Moissl Ulrich
• Chamney Paul
• Groeber Tobias
• Wabel Peter

Classifications

• A61B5/053 Primary

  Measuring electrical impedance or conductance of a portion of the body · CPC title

• A61B2560/0228

  using calibration standards · CPC title

• A61B2560/0252

  using ambient temperature · CPC title