Methods and apparatuses for determining a patient's daily loss of iron

Patent metadata

Field	Value
Publication number	US-10406272-B2
Application number	US-201415026319-A
Country	US
Kind code	B2
Filing date	Oct 1, 2014
Priority date	Oct 1, 2013
Publication date	Sep 10, 2019
Grant date	Sep 10, 2019

Abstract

A method for determining or approximating a patient's daily loss of iron (fe_loss), the method comprising the steps of determining the patient's iron uptake (fe_uptake); determining the quantity of iron stored within the patient's body; and determining the patient's daily loss of iron based on the patient's iron uptake (fe_uptake) and the quantity of non-functional iron stored within the patient's body. The method relates further to apparatuses and an erythropoesis stimulating medicament for use in the treatment of anaemia. Finally the present invention relates to digital storage means, a computer program product, and a computer program.

First claim

The invention claimed is:

1. A method for determining or approximating a daily loss of iron (fe_loss) of a patient with impaired renal function, the method comprising the steps:
determining the patient's iron uptake (fe_uptake);
determining a quantity of iron stored within the patient's body by adding at least a value representing a quantity of functional iron stored in the patient's body and a value representing a quantity of non-functional iron stored in the patient's body;
measuring at least one of: a hemoglobin value (Hb), a blood volume, and a concentration of ferritin in serum;
determining the patient's daily loss of iron based on the patient's iron uptake (fe_uptake) and the quantity of non-functional iron stored in the patient's body, using the formula:
fe_loss=fe_non-functional_stored+fe_Hb−fe_uptake

wherein:
fe_uptake =the patient's iron uptake
fe_loss =the patient's daily loss of iron
fe_Hb =the quantity of iron stored within the haemoglobin (Hb)
fe_non-functional stored =the quantity of iron stored within the patient's body outside of Hb; and

administering a supplemental dosage of iron to the patient during or between dialysis sessions,
wherein the supplemental dosage is determined based on the patient's determined daily loss of iron.

2. The method according to claim 1 , wherein at least one of:
the functional iron stored in the patient's body is determined using at least one of the haemoglobin value (Hb) and the blood volume; and
the quantity of non-functional iron stored within the patient's body is determined using the concentration of ferritin in serum.

3. The method according to claim 1 , further comprising at least one of:
determining the patient's iron uptake (fe_uptake) based on cumulating the patient's iron uptake over time; and
determining a ferritin curve comprising a series of ferritin measurements over time.

4. A medicament comprising iron for use in the treatment or prevention of anaemia or for enhancing haemoglobin concentration in a patient's blood, wherein the dose of iron to be administered as an iron substitution is set equal to the amount of iron determined to have been lost since the last iron substitution based on the daily loss determined by the method according to claim 1 .

5. A non-transitory digital storage means with electrically readable control signals which are able to interact with a programmable computer system such that the method according to claim 1 will be executed.

6. A computer program product having a program code stored on a machine readable data medium for executing the method according to claim 1 when executing the program product on a computer.

7. A computer program having a program code for the execution of the method according to claim 1 when executing the program on a computer.

8. An apparatus for determining or approximating a daily loss of iron of a patient with impaired renal function, the apparatus comprising:
a device configured to input information on the patient's iron uptake (fe_uptake);
a device configured to determine a quantity of iron stored within the patient's body by adding at least a value representing a quantity of functional iron stored within the patient's body and a value representing a quantity of non-functional iron stored within the patient's body;
a device configured to measure at least one of: a haemoglobin value (Hb), a blood volume, and a concentration of ferritin in serum;
a device configured to determine the patient's daily loss of iron based on the patient's iron uptake (fe_uptake) and the quantity of iron stored within the patient's body, wherein the device is configured to determine patient's daily loss of iron using the formula:
fe_loss=fe_non-functional_stored+fe_Hb−fe_uptake

wherein:
fe _uptake=the patient's iron uptake
fe_loss=the patient's loss of iron
fe _Hb =the quantity of iron stored within the haemoglobin (Hb)
fe_non-functional_stored=the quantity of iron stored within the patient's body outside of Hb; and

a device configured to determine a supplemental dosage of iron to be administered to the patient during or between dialysis sessions, wherein the supplemental dosage is determined based on the patient's determined daily loss of iron.

9. The apparatus according to claim 8 , further comprising at least one of:
a device configured to determine the functional iron comprised by the patient by using at least one of the haemoglobin value (Hb) and the blood volume; or
a device configured to determine the quantity of non-functional iron stored within the patient's body by using the concentration of ferritin in serum.

10. The apparatus according to claim 8 , further comprising:
a device configured to determine the patient's iron uptake (fe_uptake) based on cumulating the patient's iron uptake over time; and
a device configured to determine a ferritin curve comprising a series of ferritin measurements over time.

11. A blood treatment apparatus, comprising a device for administering a medicament to a patient, and at least one apparatus according to claim 8 , or being in signal communication with the at least one apparatus according to claim 8 , wherein the device for administering the medicament is in signal communication with the device configured to determine the daily iron loss.

12. The blood treatment apparatus according to claim 11 , configured as a dialysis machine, a hemodiafiltration apparatus, or a hemofiltration apparatus.

Assignees

• Fresenius Medical Care Deutschland Gmbh

Inventors

• Moissl Ulrich
• Nier Volker
• Chamney Paul
• Wabel Peter

Classifications

• G01N2333/805

  Haemoglobins; Myoglobins · CPC title

• G01N33/90

  involving iron binding capacity of blood · CPC title

• A61B5/7246

  using correlation, e.g. template matching or determination of similarity · CPC title

• A61B5/0537

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

• A61B5/02042

  Determining blood loss or bleeding, e.g. during a surgical procedure · CPC title