Method for determining a treatment parameter on a haemofiltration device, and haemofiltration device for applying the method

• US 6,939,471 B2
• Filed: 03/21/2003
• Issued: 09/06/2005
• Est. Priority Date: 03/19/2002
• Status: Expired due to Term

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA)
• Inventors: Gross, Malte, Maierhofer, Andreas
• Primary Examiner(s): KIM, SUN U
• Application Number:
  US10/393,361
• Publication Number:
  US 20030230533A1
• Time in Patent Office: 900 Days
• Field of Search: 210/85, 210/87, 210/97, 210/103, 210/109, 210/134, 210/141, 210/143, 210/252, 210/258, 210/321.6, 210/321.71, 210/645, 210/646, 210/647, 210/649, 210/650, 210/651, 210/739, 210/746, 604/4.01, 604/5.01, 604/6.11
• US Class Current: 210/746
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1603 Regulation parameters
• CPC Class Codes: A61M 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 1/1654 Dialysates therefor
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/361 before treatment
• CPC Class Codes: A61M 2202/0498 Urea
• CPC Class Codes: A61M 2205/15 Detection of leaks
• 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 2205/52 with memories providing a history of measured variating parameters of apparatus or patient

Abstract

A method for determining a treatment parameter on a haemofiltration device, as well as a haemofiltration device for applying the method, based on the recognition that a determination method known from haemodialysis can, with little modification, be transferred to haemofiltration. To this effect a physical-chemical characteristic of the substitution fluid and of the fluid which is removed from the haemofilter by way of an ultrafiltrate outlet pipe, is determined. Furthermore, this characteristic is acquired before, after or during a change of this characteristic in the substitution fluid, and is evaluated. As a result, the ion dialysance and thus the urea clearance of a haemofiltration device, which can also be operated as a haemodiafiltration device, can be determined.

Claims

1. A method for determining a treatment parameter on a haemofiltration device having a blood cleansing element divided into first and second chambers by a semipermeable membrane, said first chamber forming part of an ultrafiltrate outlet system and said second chamber forming part of an extracorporeal blood circulation system, the device also having a substitution-fluid addition system with which substitution fluid can be added to the extracorporeal blood circulation system, the method comprising the steps of:

determining a fluid flow Qo led away from the first chamber;

determining a first physical-chemical characteristic Cs1 in the substitution fluid and a corresponding first physical-chemical characteristic Cf1 in the fluid led away;

changing the physical-chemical characteristic Cs in the substitution fluid;

determining a second physical-chemical characteristic Cs2 in the substitution fluid and a second corresponding physical-chemical characteristic Cf2 in the fluid led away; and

determining a treatment parameter from the determined values of the fluid flow Qo led away, the physical-chemical characteristics Cs1 and Cs2 in the substitution fluid, and the physical-chemical characteristics Cf1 and Cf2 in the fluid led away.

2. The method according to claim 1, wherein the change in the physical-chemical characteristic Cs is step-shaped or bole-shaped.

3. The method according to claim 2, wherein the treatment parameter is a dialysance of the blood cleansing element, and is determined according to the following expression, with Δ

Cf=Cf2−

Cf1 and Δ

Cs=Cs2−

Cs1;

$D=\left(1-\frac{\mathrm{\Delta <br><br>}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{Cf}}{\mathrm{\Delta <br><br>}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{Cs}}\right)·<br><br>\mathrm{Qo}.$

4. The method according to claim 1, wherein the treatment parameter is a blood input concentration Cbi.

5. The method according to claim 1, further comprising the steps of:

determining an ultrafiltrate flow Qf removed in total from the extracorporeal circulation system as a first value;

determining a substitution fluid flow Qs as a second value;

determining, from a sum of the first and second values, the removed fluid flow Qo.

6. The method according to claim 1, further comprising the steps of:

admitting dialysis fluid at a flow Qd into the first chamber; and

determining the removed fluid flow Qo as a sum of an ultrafiltrate flow Qf removed in total from the extracorporeal circulation system, a substitution fluid flow Qs and the added flow Qd.

7. The method according to claim 6, wherein a blood flow Qb is determined as the effective blood plasma flow which flows into the blood inlet pipe and in which the change in the physical-chemical characteristic can have an effect.

8. The method according to claim 7, wherein a first dialysance value D1 is determined in a first set of flows Qd1, Qb1, Qs1 and Qf1 and subsequently a second dialysance value D2 is calculated for a second set of flows Qd2, Qb2, Qs2 and Qf2, based on the values of the first set of flows and D1.

9. The method according to claim 8, wherein based on several dialysance values D1i determined at various points in time i during haemofiltration treatment, and several dialysance values D2j calculated at various points in time j during haemofiltration treatment, a total treatment efficiency Kt achieved is determined by summation of the corresponding dialysance values, multiplied by a time difference to the previous or subsequent instance of measuring/calculation.

10. A haemofiltration device comprising:

a blood cleansing element divided into two chambers by a semipermeable membrane, with a first chamber forming part of an ultrafiltrate outlet system and a second chamber forming part of an extracorporeal blood circulation system;

said extracorporeal blood circulation system including a blood inlet pipe which leads to the second chamber, and a blood outlet pipe which removes blood from the second chamber;

said ultrafiltrate outlet system including an ultrafiltrate outlet pipe which removes the fluid from the first chamber, and an ultrafiltrate conveyance device for targeted fluid removal from a removal flow Qo through the membrane via the ultrafiltrate outlet pipe;

a substitution fluid addition system having a substitution fluid pipe which leads from a source for the provision of substitution fluid to the extracorporeal blood circulation system, and a substitution conveyance device for conveying substitution fluid in the substitution fluid pipe;

a first sensor element arranged on the substitution fluid pipe for determining a physical-chemical characteristic Cs of the substitution fluid;

a second sensor element arranged on the ultrafiltrate outlet pipe for determining the corresponding physical-chemical characteristic Cf of the fluid led away;

a device for changing the physical-chemical property Cs of the substitution fluid; and

an evaluation and control unit which records first measured values Cs1 and Cf1 of the first and second sensor elements, respectively, and then controls said device for changing the physical-chemical characteristic of the substitution fluid so as to effect a change in said physical-chemical characteristic;

said evaluation and control unit recording second measured values Cs2 and Cf2 of the first and second sensor elements, respectively, said second values having changed from said first values because of the change in said physical-chemical characteristic; and

said evaluation and control unit determining a treatment parameter from the values Cs1, Cs2, Cf1, Cf2, and Qo.

11. The haemofiltration device according to claim 10, wherein the evaluation and control unit controls the device for changing the physical-chemical characteristic of the substitution fluid such that the change is step-shaped or bole-shaped.

12. The haemofiltration device according to claim 11, wherein the treatment parameter is a dialysance of the blood cleansing element, and the evaluation and control unit determines the dialysance according to the following expression, with Δ

Cf=Cf2−

Cf1 and Δ

Cs =Cs2−

Cs1;

$D=\left(1-\frac{\mathrm{\Delta <br><br>}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{Cf}}{\mathrm{\Delta <br><br>}<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{Cs}}\right)·<br><br>\mathrm{Qo}.$

13. The haemofiltration device according to claim 10, wherein the treatment parameter is a blood input concentration Cbi.

14. The haemofiltration device according to claim 10, wherein the evaluation and control unit saves set values and/or measured values for a total ultrafiltrate flow Qf to be removed from the extracorporeal blood circulation system, and a substitute-fluid flow Qs, and as a sum of these two flows Qf, Qs, determines the removal flow Qo.

15. The haemofiltration device according to claim 10, wherein the source for providing substitution fluid is also a source for providing dialysis fluid, from which source a dialysis fluid inlet pipe leads to the first chamber.

16. The haemofiltration device according to claim 15, wherein the evaluation and control unit saves the removal flow Qo as the sum of set values and/or measured values for a total ultrafiltrate flow Qf to be removed from the extracorporeal blood circulation system, a substitute-fluid flow Qs, and a dialysis fluid flow Qd flowing into the first chamber.

17. The haemofiltration device according to claims 15, wherein an inlet portion of the substitution fluid pipe and the dialysis fluid inlet pipe are a common pipe in a first section and, after branching off, are separate pipes in a second section.

18. The haemofiltration device according to claim 10, further comprising a first balancing device in the substitution fluid pipe and a second balancing device in the ultrafiltrate outlet system.

19. The haemofiltration device according to claim 18, wherein the ultrafiltrate outlet pipe branches into a first pipe and a second pipe, the first pipe passing through a first part of the second balancing device, said second pipe including a device for conveying a total ultrafiltrate flow Qf to be removed from the extracorporeal circulation system as a second part of the second balancing device, said substitution fluid pipe passing through the first balancing device, said first balancing device and said first part of said second balancing device forming a balancing chamber.

20. The haemofiltration device according to claim 18, wherein at least one of the first and second balancing devices is designed such that a sum of a substitution fluid flow Qs and a dialysis fluid flow Qd can be determined and can be acquired by the evaluation and control unit.

21. The haemofiltration device according to claim 20, wherein at least one of the first and second balancing devices is designed so that, from the flows flowing therethrough, a total ultrafiltrate flow Qf to be removed from the extracorporeal circulation system can be determined and can be acquired by the evaluation and control unit.

22. The haemofiltration device according to claim 10, wherein an inlet portion of the substitution fluid pipe leads into the blood outlet pipe (post-dilution).

23. The haemofiltration device according to claim 10, wherein an inlet portion of the the substitution fluid pipe leads into the blood inlet pipe (pre-dilution).

24. The haemofiltration device according to claim 10, wherein the physical-chemical characteristic is a concentration.

25. The haemofiltration device according to claim 24, wherein the first and second sensor elements are conductivity sensors.

26. The haemofiltration device according to claim 21, wherein the evaluation and control unit saves a blood flow Qb as an effective fluid flow which flows into the blood inlet pipe and in which the change of the physical-chemical characteristic can have an effect.

27. The haemofiltration device according to claim 26, wherein the evaluation and control unit saves a first dialysance value D1 in a first saved set of flows Qd1, Qb1, Qs1 and Qf1 and on the basis of these values calculates a second dialysance value D2 for a second set of flows Qd2, Qb2, Qs2 and Qf2.

28. The haemofiltration device according to claim 27, wherein the evaluation and control unit, based on several saved dialysance values D1i determined at various points in time i during haemofiltration treatment, and several saved dialysance values D2j calculated at various points in time j during haemofiltration treatment, determines a treatment efficiency Kt achieved, by summation of the corresponding dialysance values, multiplied by a time difference to the previous or subsequent instance of measuring/calculation.

29. The haemofiltration device according to claim 10, further comprising a display device on which the treatment parameter can be displayed.

30. The haemofiltration device according to claim 29, wherein the treatment parameter displayed is selected from the group consisting of a dialysance D, interim results and an actual treatment efficiency Kt.