Calibration of a body parameter for monitoring dialysis

Patent metadata

Field	Value
Publication number	US-10195328-B2
Application number	US-201314409685-A
Country	US
Kind code	B2
Filing date	Jul 18, 2013
Priority date	Jul 19, 2012
Publication date	Feb 5, 2019
Grant date	Feb 5, 2019

Abstract

A method and an apparatus for detecting a change of the fluid status or determining the fluid status of an individual are disclosed. The method comprises the following steps: determining a change of the body parameter (ΔRBV) of the individual during a first treatment session (201); determining a first fluid status of the individual (202); calibrating the determined change of the body parameter (ΔRBV) based on the first fluid status (205); determining the change of the body parameter (ΔRBV) of the individual during at least one further treatment session (207); and deriving a fluid status or a change of fluid status individual from the change of the body parameter (ΔRBV) (208).

First claim

The invention claimed is:

1. An apparatus comprising:
a digital signal processor having a memory;
a first determination unit operative with said digital signal processor and configured to determine a normalized change of a blood parameter (ΔRBV) of an individual during a treatment session;
a second determination unit operative with said digital signal processor and configured to determine a fluid status of the individual; and
a calibration unit operative with said digital signal processor and adapted to calibrate the determined normalized change of the blood parameter (ΔRBV) provided by the first determination unit based on the fluid status provided by the second determination unit;
the apparatus being configured to perform a quantitative determination of the fluid status or a change in the fluid status by:
determining, using at least the first determination unit, a first change of the blood parameter (ΔRBV) of the individual during a first treatment session normalized by at least one of ultrafiltration volume and ultrafiltration rate of the first treatment session;
determining, using at least the second determination unit, a first fluid status of the individual;
calibrating, using at least the calibration unit, the determined normalized first change of the blood parameter (ΔRBV) based on the first fluid status;
determining, using at least the first determination unit, a further change of the blood parameter during at least one further treatment session normalized by at least one of ultrafiltration volume and ultrafiltration rate of the at least one further treatment session;
deriving, using at least the second determination unit, the fluid status or a change in the fluid status from the normalized further change of the blood parameter; and
using the derived fluid status or the change in fluid status as determined using the apparatus to detect fluid overload and to mitigate health risks to the individual related to fluid overload.

2. The apparatus, according to claim 1 , wherein the calibration unit is further adapted to determine a second normalized change of the blood parameter (ΔRBV) and a second fluid status during a second treatment session, wherein the calibration of the change of the blood parameter (ΔRBV) is based on the normalized first and second changes of the blood parameter (ΔRBV) and on the first and second fluid status.

3. The apparatus according to claim 1 , wherein the blood parameter includes a concentration of hemoglobin in the blood.

4. The apparatus according to claim 1 , wherein the treatment session is a dialysis and/or ultrafiltration treatment session.

5. The apparatus according to claim 1 , wherein the apparatus approximates the change of the blood parameter (ΔRBV) using a polynomial regression.

6. The apparatus according to claim 5 , wherein the calibration unit is configured to determine at least one constant C and/or a coefficient k of a polynomial.

7. The apparatus according to claim 1 , wherein the fluid status is determined by an assessment of a blood composition of the individual.

8. The apparatus according to claim 1 , in combination with a database, wherein the combination is configured to operate such that a first and/or second fluid status, an updated fluid status, a normal fluid status, a normohydration weight or any other data gained throughout a treatment session is transferred to the database via a data connection.

9. The combination according to claim 8 , wherein the database is operated at a central server.

10. The combination according to claim 8 wherein the transferred data is processed such that statistics and/or conclusions for the treatment of the individual and/or a specific group of individuals with comparable body parameters, may be derived.

11. The apparatus according to claim 1 , wherein the apparatus is adapted to use the fluid status and/or any other data gained throughout at least one of the treatment sessions to determine a dosage of a medicament selected from the group consisting of EPO, sodium and iron preparations.

12. The apparatus according to claim 1 , wherein the apparatus is configured to determine the fluid status by bioimpedance spectroscopy of the individual.

13. Computer-readable non-transitory storage medium comprising instructions to be executed on an apparatus, said apparatus including a memory, a digital signal processor, a first determination unit configured to determine a normalized change of a blood parameter (ΔRBV) of an individual during a treatment session, a second determination unit to determine a fluid status of the individual, and a calibration unit to calibrate the determined normalized change of the blood parameter (ΔRBV) based on the fluid status, the instructions configured for controlling the apparatus to perform a quantitative determination of the fluid status or a change in the fluid status by determining a first change of the blood parameter (ΔRBV) of the individual during a first treatment session normalized by at least one of ultrafiltration volume and ultrafiltration rate of the first treatment session using at least the first determination unit, to determine a first fluid status of the individual using at least the second determination unit, to calibrate the determined normalized first change of the blood parameter (ΔRBV) based on the first fluid status using at least the calibration unit, to determine a further change of the blood parameter during at least one further treatment session normalized by at least one of ultrafiltration volume and ultrafiltration rate of the at least one further treatment session using at least the first determination unit, to derive the fluid status or a change in the fluid status from the normalized further change of the blood parameter using at least the second determination unit, and to use the derived fluid status or the change in fluid status to detect fluid overload and to mitigate health risks to the individual related to fluid overload.

Assignees

• Fresenius Medical Care Deutschland Gmbh

Inventors

• Chamney Paul
• Moissl Ulrich
• Wabel Peter
• Wieskotten Sebastian

Classifications

• A61B5/4875

  Hydration status, fluid retention of the body · CPC title

• A61B5/4881

  Determining interstitial fluid distribution or content within body tissue (measuring analytes in interstitial fluid in-vivo A61B5/1451) · CPC title

• A61B5/0537 Primary

  Measuring body composition by impedance, e.g. tissue hydration or fat content · CPC title

• A61M1/1603 Primary

  Regulation parameters · CPC title