Method for determining the distribution volume of a blood component during an extracorporeal blood treatment and device for carrying out the method

• US 7,077,819 B1
• Filed: 12/23/1999
• Issued: 07/18/2006
• Est. Priority Date: 12/24/1998
• Status: Expired due to Fees

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Inventors: Gross, Malte, Graf, Thomas, Goldau, Rainer
• Primary Examiner(s): Bianco, Patricia
• Assistant Examiner(s): Deak, Leslie R.
• Application Number:
  US09/868,950
• Time in Patent Office: 2,399 Days
• Field of Search: 210645-646, 210/739, 210/746, 210/96.2, 210/85, 210/321.75, 210/600, 210/649, 210/634, 210/651, 210/929, 210/500.21, 210/433.1, 210/321.65, 210/321.71, 604/6.09, 604/6.04, 604/6.11, 604/6.01, 604/4.01, 604/5.01, 604/5.04, 604/6.1, 600/366, 600/322, 600/368
• US Class Current: 604/5.04
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1607 before use, i.e. upstream of dialyser
• CPC Class Codes: A61M 1/1609 after use, i.e. downstream of dialyser
• CPC Class Codes: A61M 1/1617 using measurements made during a temporary variation of a characteristic of the fresh dialysis fluid
• CPC Class Codes: A61M 1/1635 with volume chamber balancing devices between used and fresh dialysis fluid
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3313 used specific wavelengths
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2230/65 Impedance, e.g. conductivity, capacity

Abstract

The invention relates to a method for determining the volume of distribution of a blood component in the body of a living organism, especially the volume of distribution of urea, during an extracorporeal blood treatment. According to this method, the blood to be treated flows through the blood chamber (3) of a dialysis machine (1) in an extracorporeal circuit, said dialysis machine being divided into said blood chamber and a dialysing liquid chamber (4) by a semipermeable membrane (2). Dialysing liquid flows through the dialysing liquid chamber of the dialysis machine in a dialysing liquid channel. The method is based on the determination of the temporal change in the concentration of the blood component in the blood upstream of the dialysis machine using the temporal variation in a physical or chemical characteristic of the dialysing liquid upstream and downstream of the dialysis machine and the determination of the volume of distribution of the substance in the body of a living organism using the temporal variation in the concentration of the blood component in the blood. The invention also relates to a device for the extracorporeal blood treatment, comprising a device for determining the volume of distribution of a blood component in the body of a living organism.

Claims

1. A method for determining the distribution volume of a blood component in the body of an organism during an extracorporeal blood treatment, in which the blood to be treated flows in an extracorporeal circuit through the blood chamber of a dialyzer subdivided by a semipermeable membrane into the blood chamber and a dialyzing-fluid chamber, and dialyzing fluid flows in a dialyzing-fluid path through the dialyzing-fluid chamber of the dialyzer, comprising the following method steps:

bringing about a change in the concentration of the blood component in the blood upstream of the dialyzer by a change in the concentration of the blood component in the dialyzing fluid upstream of the dialyzer; and

measuring the change in the concentration of the blood component in the dialyzing fluid downstream of the dialyzer which can be attributed to the change in the concentration of the blood component in the blood as a result of the change in the concentration of the blood component in the dialyzing fluid upstream of the dialyzer; and

determining the distribution volume V of the blood component from the change in the concentration of the blood component in the dialyzing fluid upstream and downstream of the dialyzer.

2. The method as recited in claim 1, wherein the concentration of the blood component in the dialyzing fluid in the dialyzing-fluid path is measured upstream of the dialyzer.

3. The method as recited in claim 1, wherein the conductivity of the dialyzing fluid is measured as the concentration of the blood component for determining the distribution volume of sodium in the blood.

4. The method as recited in claim 3, wherein the sodium distribution volume is ascertained for determining the distribution volume of urea in the blood, and the urea distribution volume is determined from the sodium distribution volume.

5. The method as recited in claim 4, wherein the urea distribution volume is determined under the assumption that the sodium distribution volume essentially corresponds to the urea distribution volume.

6. A method for determining the distribution volume of a blood component in the body of an organism during an extracorporeal blood treatment, in which the blood to be treated flows in an extracorporeal circuit through the blood chamber of a dialyzer subdivided by a semipermeable membrane into the blood chamber and a dialyzing-fluid chamber, and dialyzing fluid flows in a dialyzing-fluid path through the dialyzing-fluid chamber of the dialyzer, comprising the following method steps:

the concentration of the blood component in the dialyzing fluid is altered in the dialyzing-fluid path upstream of the dialyzer and the concentration of the blood component in the dialyzing fluid is measured downstream of the dialyzer;

the change as a function of time in the concentration of a blood component in the blood upstream of the dialyzer Δ

cbi as a result of the change in the concentration of the blood component in the dialyzing fluid upstream of the dialyzer is determined from the concentration of the blood component in the dialyzing fluid upstream and downstream of the dialyzer after the concentration of the blood component in the dialyzing fluid has been altered; and

the distribution volume V of the blood component is determined from the change as a function of time in the concentration of the blood component in the blood.

7. The method as recited in claim 6, wherein the concentration of the blood component in the dialyzing fluid in the dialyzing-fluid path is measured upstream of the dialyzer.

8. A method for determining the distribution volume of a blood component in the body of an organism during an extracorporeal blood treatment, in which the blood to be treated flows in an extracorporeal circuit through the blood chamber of a dialyzer subdivided by a semipermeable membrane into the blood chamber and a dialyzing-fluid chamber, and dialyzing fluid flows in a dialyzing-fluid path through the dialyzing-fluid chamber of the dialyzer, comprising the following method steps:

bringing about a change in the concentration of a blood component in the blood upstream of the dialyzer by a change in a physical or chemical characteristic in the dialyzing fluid upstream of the dialyzer; and

measuring the change in the physical or chemical characteristic in the dialyzing fluid downstream of the dialyzer which can be attributed to the change in the concentration of the blood component in the blood; and

determining the distribution volume V of the blood component from the change in the physical or chemical characteristic in the dialyzing fluid upstream and downstream of the dialyzer,

wherein the physical or chemical characteristic of the dialyzing fluid in the dialyzing-fluid path is increased at a point of time t₀ from a predetermined first value cdi₀ to a predetermined second value cdi₁, is reduced at a point of time t₁>

t₀ to a predetermined third value cdi₂, and is increased at a point of time t₂>

t₁ to a predetermined fourth value cdi₀ which is equal to the first value, the value by which the characteristic is increased being half as large as the value by which the characteristic is reduced.

9. The method as recited in claim 8, wherein the time interval t₁−

t₀ is equal to the time interval t₂−

t₁.

10. The method as recited in claim 8, wherein the change as a function of time in the concentration of a blood component in the blood upstream of the dialyzer Δ

cbi is ascertained from;

the predetermined first value cdi₀ of the physical or chemical characteristic of the dialyzing fluid upstream of the dialyzer and the value cdo₀ of the characteristic that ensues downstream of the dialyzer, and the predetermined second value cdi₁ of the characteristic upstream of the dialyzer and the value cdo₁ of the characteristic which ensues downstream of the dialyzer after the increase in the characteristic upstream of the dialyzer to the predetermined second value, and the predetermined third value cdi₂ of the characteristic upstream of the dialyzer and the value cdo₂ of the characteristic which ensues downstream of the dialyzer after the decrease in the characteristic upstream of the dialyzer to the predetermined third value.

11. The method as recited in claim 10, wherein the dialyzing fluid is balanced such that the volume of the dialyzing fluid flowing into the dialyzer during the measurement is equal to the volume of the dialyzing fluid flowing out of the dialyzer.

12. An apparatus for determining the distribution volume of a blood component in the body of an organism during an extracorporeal blood treatment in conjunction with an extracorporeal blood-treatment device, in which the blood to be treated flows in an extracorporeal circuit through the blood chamber of a dialyzer subdivided by a semipermeable membrane into the blood chamber and a dialyzing-fluid chamber, and dialyzing fluid flows in a dialyzing-fluid path through the dialyzing-fluid chamber of the dialyzer, having

a device configured to alter the concentration of the blood component in the dialyzing fluid in the dialyzing-fluid path upstream of the dialyzer, and

a measuring device configured to determine the concentration of the blood component in the dialyzing fluid in the dialyzing-fluid path downstream of the dialyzer,

wherein the apparatus comprises an arithmetic and evaluation configured in such a way that the distribution volume V of the blood component can be determined from a change in the concentration of the blood component in the dialyzing fluid downstream of the dialyzer which can be attributed to the change in the concentration of the blood component in the blood as a result of the change in the concentration of the blood component in the dialyzing fluid upstream of the dialyzer.

13. The apparatus as recited in claim 12, wherein a measuring device is provided for detecting the concentration of the blood component in the dialyzing fluid in the dialyzing-fluid path upstream of the dialyzer.

14. The apparatus as recited in claim 13, wherein the measuring devices for detecting the concentration of the blood component have a conductivity sensor, optical sensor or enzyme sensor arranged in the dialyzing-fluid path downstream and upstream, respectively, of the dialyzer.

15. The apparatus as recited in claim 12, wherein the device for altering the concentration of the blood component is designed in such a way that the concentration of the blood component is increased at a point of time t₀ from a predetermined first value cdi₀ to a predetermined second value cdi₁, is reduced at a point of time t₁>

t₀ to a predetermined third value cdi₂, and is increased at a point of time t₂>

μ

t₁ to a predetermined fourth value cdi₀ which is equal to the first value, the value by which the concentration of the blood component is increased being half as large as the value by which the concentration of the blood component is reduced.

16. The apparatus as recited in claim 15, wherein the time interval t₁−

t₀ is equal to the time interval t₂−

t₁.

17. The apparatus as recited in claim 15, wherein the arithmetic and evaluation unit is designed in such a way that the predetermined first, second and third values cdi₀, cdi₁, cdi₂ of the concentration of the blood component in the dialyzing fluid upstream of the dialyzer and the values cdo₀, cdo₁, cdo₂ of the concentration of the blood component in the dialyzing fluid ensuing downstream of the dialyzer are evaluable for determining the change as a function of time in the concentration of the blood component Δ

cbi.

18. The apparatus as recited in claim 12, wherein a balancing device is provided with which the dialyzing fluid can be balanced in such a way that the volume of the dialyzing fluid flowing into the dialyzer during the measurement is equal to the volume of the dialyzing fluid flowing out of the dialyzer.

19. An apparatus for determining the distribution volume of a blood component in the body of an organism during an extracorporeal blood treatment in conjunction with an extracorporeal blood-treatment device, in which the blood to be treated flows in an extracorporeal circuit through the blood chamber of a dialyzer subdivided by a semipermeable membrane into the blood chamber and a dialyzing-fluid chamber, and dialyzing fluid flows in a dialyzing-fluid path through the dialyzing-fluid chamber of the dialyzer, having

a device configured to alter the concentration of the blood component in the dialyzing fluid in the dialyzing-fluid path upstream of the dialyzer, and

a measuring device configured to determine the concentration of the blood component in the dialyzing fluid in the dialyzing-fluid path downstream of the dialyzer,

wherein the apparatus comprises an arithmetic and evaluation configured in such a way that the change as a function of time in the concentration of the blood component Δ

cbi in the blood upstream of the dialyzer as a result of the change in the concentration of the blood component in the dialyzing fluid upstream of the dialyzer can be determined from the concentration of the blood component in the dialyzing fluid upstream and downstream of the dialyzer after the concentration of the blood component in the dialyzing fluid has been altered, and the distribution volume V of the blood component can be determined from the change as a function of time in the concentration of the blood component upstream of the dialyzer.

20. The apparatus as recited in claim 19, wherein a measuring device is provided for detecting the concentration of the blood component in the dialyzing fluid in the dialyzing-fluid path upstream of the dialyzer.

21. The apparatus as recited in claim 19, wherein the device for altering the concentration of the blood component is designed in such a way that the concentration of the blood component is increased at a point of time t₀ from a predetermined first value cdi₀ to a predetermined second value cdi₁, is reduced at a point of time t₁>

t₀ to a predetermined third value cdi₂, and is increased at a point of time t₂>

t₁ to a predetermined fourth value cdi₀ which is equal to the first value, the value by which the concentration of the blood component is increased being half as large as the value by which the concentration of the blood component is reduced.

22. The apparatus as recited in claim 19, wherein the arithmetic and evaluation unit is designed in such a way that the predetermined first, second and third values cdi₀, cdi₁, cdi₂ of the concentration of the blood component in the dialyzing fluid upstream of the dialyzer and the values cdo₀, cdo₁, cdo₂ of the concentration of the blood component in the dialyzing fluid ensuing downstream of the dialyzer are evaluable for determining the change as a function of time in the concentration of the blood component Δ

cbi.

23. The apparatus as recited in claim 19, wherein a balancing device is provided with which the dialyzing fluid can be balanced in such a way that the volume of the dialyzing fluid flowing into the dialyzer during the measurement is equal to the volume of the dialyzing fluid flowing out of the dialyzer.

24. A method for determining the distribution volume of a blood component in the body of an organism during an extracorporeal blood treatment, in which the blood to be treated flows in an extracorporeal circuit through the blood chamber of a dialyzer subdivided by a semipermeable membrane into the blood chamber and a dialyzing-fluid chamber, and dialyzing fluid flows in a dialyzing-fluid path through the dialyzing-fluid chamber of the dialyzer, comprising the following method steps:

a physical or chemical characteristic of the dialyzing fluid is altered in the dialyzing-fluid path upstream of the dialyzer, and the physical or chemical characteristic of the dialyzing fluid is measured downstream of the dialyzer;

the change as a function of time in the concentration of a blood component in the blood upstream of the dialyzer Δ

cbi is determined from the physical or chemical characteristic of the dialyzing fluid upstream and downstream of the dialyzer; and

the distribution volume V of the blood component is determined from the change as a function of time in the concentration of a blood component in the blood, wherein the physical or chemical characteristic of the dialyzing fluid in the dialyzing-fluid path is increased at a point of time t₀ from a predetermined first value cdi₀ to a predetermined second value cdi₁, is reduced at a point of time t₁>

t₀ to a predetermined third value cdi₂, and is increased at a point of time t₂>

t₁ to a predetermined fourth value cdi₀ which is equal to the first value, the value by which the characteristic is increased being half as large as the value by which the characteristic is reduced.

25. The method as recited in claim 24, wherein the change as a function of time in the concentration of a blood component in the blood upstream of the dialyzer Δ

cbi is ascertained from;

the predetermined first value cdi₀ of the physical or chemical characteristic of the dialyzing fluid upstream of the dialyzer and the value cdo₀ of the characteristic that ensues downstream of the dialyzer, and the predetermined second value cdi₁ of the characteristic upstream of the dialyzer and the value cdo₁ of the characteristic which ensues downstream of the dialyzer after the increase in the characteristic upstream of the dialyzer to the predetermined second value, and the predetermined third value cdi₂ of the characteristic upstream of the dialyzer and the value cdo₂ of the characteristic which ensues downstream of the dialyzer after the decrease in the characteristic upstream of the dialyzer to the predetermined third value.