Method and device for determining hemodialysis parameters

• US 6,126,831 A
• Filed: 08/13/1998
• Issued: 10/03/2000
• Est. Priority Date: 08/13/1997
• Status: Expired due to Term

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Inventors: Kramer, Matthias, Goldau, Rainer
• Primary Examiner(s): Drodge, Joseph W.
• Application Number:
  US09/133,252
• Time in Patent Office: 782 Days
• Field of Search: 210/85, 210/87, 210/94, 210/96.2, 210/138, 210/321.65, 210/321.69, 210/321.71, 210/416.1, 210/646, 210/647, 210/739, 210/746, 210/929, 210/637, 210/745, 604/4-6, 604/4.01, 604/5.01, 604/6.01, 604/6.09, 604/6.15
• US Class Current: 210/646
• 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 1/1615 using measurements made at different flow rates
• CPC Class Codes: A61M 1/165 with a dialyser bypass on the dialysis fluid line
• CPC Class Codes: A61M 1/361 before treatment
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• 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 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2230/65 Impedance, e.g. conductivity, capacity
• CPC Class Codes: Y10S 210/929 Hemoultrafiltrate volume measurement or control processes

Abstract

A device and method are described to determine the concentration of a substance in blood flowing through a blood chamber of a dialyzer during extra corporeal blood treatment. The flow rate of dialysate flowing through the dialysate chamber of the dialyzer is reduced to a value at which the concentration of the substance at the outlet of the dialysate chamber is essentially the same as the concentration of that same substance in the blood at the inlet of the blood chamber. The concentration measurement can be carried out without interrupting the flow of dialysate.

Claims

1. A method for determining at least one hemodialysis parameter during an extracorporeal blood treatment using a dialyzer divided by a semipermeable membrane into a blood chamber and a dialysate chamber;

the method comprising;

passing blood to be treated in an extracorporeal blood circulation path through the blood chamber at a preset blood flow rate;

passing dialysate in a dialysate path from a dialysate source through the dialysate chamber to a drain at a dialysate flow rate;

setting the dialysate flow rate in the dialysate path to a set dialysate flow rate where a concentration of a substance in dialysate flowing out of the dialysate chamber substantially adopts a concentration of the substance in the blood flowing into the blood chamber; and

measuring the concentration of the substance in the dialysate flowing out of the dialysate chamber, the at least one hemodialysis parameter being a function of the concentration of the substance in the dialysate flowing out of the dialysate chamber.

2. The method as recited in claim 1 wherein the concentration of the substance in the dialysate flowing out of the dialysate chamber is the at least one hemodialysis parameter.

3. The method as recited in claim 1 further comprising the step of substantially completing the extracorporeal blood treatment before the step of reducing the dialysate flow rate from a first preset value to the set dialysate flow rate.

4. The method as recited in claim 1 wherein the set dialysate flow rate is set at the beginning of a blood treatment and further comprising, after measuring the concentration of the substance in the dialysate flowing out of the dialysate chamber, raising the dialysate flow rate to a first preset flow rate.

5. The method as recited in claim 1 further comprising the steps of starting from a predetermined dialysate flow rate, reducing the dialysate flow rate to the set dialysate flow rate, and restoring the dialysate flow rate to the predetermined dialysate flow rate after measuring the concentration of the substance flowing out of the dialysate chamber.

6. The method as recited in claim 5 further comprising the steps of, after restoring the dialysate flow rate to the predetermined dialysate flow rate, measuring a concentration of the substance flowing into the dialysate chamber, and determining a dialysance D using the equation:

##EQU7## where;

D=dialysance

Q_d =the dialysate flow rate

c_do =the concentration of the substance in the dialysate flowing out of the dialysate chamber

c_di =the concentration of the substance in the dialysate flowing into the dialysate chamber

c_bi =the concentration of the substance in the blood flowing into the blood chamber determined in the measuring step.

dialysance D being one of the at least one hemodialysis parameter.

7. The method as recited in claim 1 wherein the concentration of the substance in the dialysate flowing out of the dialysate chamber is measured after establishment of a steady state.

8. The method as recited in claim 7 wherein the steady state is established in a preset time interval in the range of 1 to 5 minutes.

9. The method as recited in claim 1 wherein the set dialysate flow rate is less than 100 mL/min at a blood flow rate greater than 300 mL/min.

10. The method as recited in claim 1 wherein the set dialysate flow rate is less than 75 mL/min at a blood flow rate greater than 150 mL/min.

11. The method as recited in claim 1 wherein the set dialysate flow rate is between 40 and 60 mL/min.

12. The method as recited in claim 11 wherein set dialysate flow rate is 50 mL/min.

13. The method as recited in claim 1 wherein the set dialysate flow rate is between 10 and 30 mL/min.

14. The method as recited in claim 13 wherein the set dialysate flow rate is 20 mL/min.

15. The method as recited in claim 1 wherein the measuring step is performed by measuring a conductivity of the dialysate.

16. A blood treatment device comprising:

a dialyzer including a blood chamber and a dialysate chamber separated by a semipermeable membrane, the blood chamber being connected to an extracorporeal blood circulation path, the dialysate chamber being connected to a dialysate path;

a blood pump connected to the extracorporeal blood circulation path;

a dialysate pump connected to the dialysate path; and

an apparatus for determining at least one hemodialysis parameter during an extracorporeal blood treatment, the apparatus including;

a measuring device disposed in the dialysate path downstream from the dialysate chamber for measuring a concentration of a substance in dialysate flowing out of the dialysate chamber;

a control unit for determining a concentration of the substance in blood flowing into the blood chamber by reducing a pumping rate in the dialysate path of the dialysate pump during the dialysis treatment, for a preset time interval, from a preset value to a reduced pumping rate in the dialysate path at which the concentration of the substance in the dialysate flowing out of the dialysate chamber as measured with the measuring device substantially adopts the concentration of the substance in blood flowing into the blood chamber, and for, after the preset time interval, raising the pumping rate of the dialysate pump to the preset value; and

an analyzer unit for receiving an output signal of the measuring device, the analyzer unit being controlled by the control unit so that the analyzer unit records the concentration of the substance in the dialysate flowing out of the dialysate chamber before the control unit sets the pumping rate of the dialysate pump to the preset value, the at least one hemodialysis parameter being a function of the concentration of the substance in the dialysate flowing out of the dialysate chamber.

17. The device as recited in claim 16 wherein the concentration of the substance in the dialysate flowing out of the dialysate chamber is the at least one hemodialysis parameter.

18. The device as recited in claim 16 wherein the apparatus further includes a second measuring device disposed in the dialysate path upstream of the dialysate chamber for measuring the concentration of the substance in dialysate flowing into the dialysate chamber, the output signal of the second measuring device being received by the analyzer unit for enabling the analyzer unit to be controlled by the control unit so that the analyzer unit records the concentration of the substance in the dialysate flowing into the dialysate chamber and records the concentration of the substance in the dialysate flowing out of the dialysate chamber when the control unit has set the pump pumping rate to the preset value after the preset time interval, and wherein the analyzer unit is capable of determining a dialysance at a preset blood flow rate, using the equation ##EQU8## where:

D=dialysance

Q_d =the preset value

c_do =the concentration of the substance in the dialysate flowing out of the dialysate chamber

c_di =the concentration of the substance in the dialysate flowing into the dialysate chamber

c_bi =the concentration of the substance in the blood flowing into the blood chamber.

19. A method for determining at least one hemodialysis parameter in vivo based on a concentration of a substance in an extracorporeal blood circulation path connected to a first chamber of a dialyzer, the first chamber being divided by a semipermeable membrane from a second chamber of the dialyzer, a dialysate circuit being connected to the second chamber, the method comprising:

interrupting dialysate flow through the second chamber for a preset time interval to establish a steady state so that dialysate in the second chamber substantially adopts, at least in a partial volume of the second chamber, a concentration of a substance in blood flowing through the extracorporeal blood circulation path into the first chamber, the interrupting of the dialysate flow occurring without an interruption of a blood flow;

flushing out of the second chamber a residual amount of the dialysate in the second chamber of the dialyzer after establishment of the steady state; and

measuring the concentration of the substance in the dialysate in the second chamber after the establishing of the steady state by measuring downstream from the dialyzer the concentration of the substance in the residual amount of the dialysate flowing out of the second chamber, the at least one hemodialysis parameter being a function of the concentration of the substance in the second chamber after the establishing of the steady state.

20. The method as recited in claim 19 wherein the concentration of the substance in the second chamber after the establishing of the steady state is the at least one hemodialysis parameter.

21. The method as recited in claim 19 further comprising bridging flow path through the second chamber using a bypass line connected to the dialysate circuit so that no flow passes through the second chamber and dialysate thereafter remaining in the second chamber is maintained in the second chamber.

22. The method as recited in claim 19 wherein the flushing step is carried out by reestablishing flow through the second chamber, and further comprising determining the concentration of the substance in blood flowing into the first chamber using the measured concentration of the substance in the dialysate in the second chamber measured after the establishing of the steady state, the concentration of the substance in blood flowing into the first chamber being one of the at least one hemodialysis parameter;

after the flushing step, measuring a dialysate flow rate and a concentration of the substance in the dialysate flowing into and a concentration of the dialysate flowing out of the dialyzer; and

, after the flushing step, determining a dialysance using the equation ##EQU9## where;

D=the dialysance

Q_d =the dialysate flow rate

c_do =the concentration of the substance in the dialysate flowing out of the dialysate chamber

c_di =the concentration of the substance in the dialysate flowing into the dialysate chamber

c_bi =the concentration of the substance in the blood flowing into the blood chamber.

23. The method as recited in claim 19 wherein the preset time interval is in the range of 1 to 3 minutes.

24. The method as recited in claim 19 wherein the concentration measuring step is performed by measuring conductivity. concentration of the substance in blood flowing into the blood chamber, of sending a signal to the interrupting device for reconnecting the dialyzer to the dialysate circuit to flush out the residual dialysate, and then, after a time interval determined by a flow rate of the dialysate and a distance of an outlet of the dialyzer from the sensor, of analyzing the output measurement signal of the sensor to determine the concentration of the substance in the residual dialysate.

25. A blood treatment device comprising:

a dialyzer including a blood chamber and a dialysate chamber separated by a semipermeable membrane, the blood chamber being capable of being connected to a dialysis patient via an extracorporeal blood circulation path, blood flowing in and out of the blood chamber at blood flow rate, the dialysate chamber being connected to a dialysate circuit, dialysate flowing in and out of the dialysate chamber at a dialysate flow rate;

at least one sensor for measuring a concentration of a substance in dialysate flowing out of the dialyzer, at least one of the at least one sensor being disposed downstream from the dialyzer;

an interrupting device for interrupting dialysate flow through the dialyzer;

a control/analyzer unit connected to the interrupting device for receiving at least an output measurement signal of the at least one sensor, the control/analyzer unit be capable of, at a time when the concentration of the substance in blood of a patient is determined, sending a signal to the interrupting device so that there is no flow in the dialysate chamber and a residual dialysate is maintained in the dialysate chamber, and, after a preset time interval to establish a steady state so that at least part of the residual dialysate substantially adopts the concentration of the substance in blood flowing into the blood chamber, of sending a signal to the interrupting device for reconnecting the dialyzer to the dialysate circuit to flush out the residual dialysate, and then, after a time interval determined by a flow rate of the dialysate and a distance of an outlet of the dialyzer from the at least one sensor, of analyzing the output measurement signal of the at least one sensor to determine the concentration of the substance in the residual dialysate.

26. A device as recited in claim 25 further comprising a bypass line for bridging the dialysate chamber when the dialysate flow is interrupted.

27. A device as recited in claim 25 wherein the control/analyzer unit is capable of sending a signal for measuring a concentration of the substance in the dialysate upstream of the dialyzer and a concentration of the substance in the dialysate downstream of the dialyzer, and of sending a signal for restoring flow in the dialysate chamber, and wherein a timing control on the control/analyzer unit is set so that after a determination of the concentration of the substance in the blood flowing into the blood chamber and a reconnection of the dialyzer to the dialysate circuit, the control/analyzer unit is capable of analyzing, as measurement signals, signals for dialysate flow rate and signals for the concentration of the substance in the dialysate flowing into and flowing out of the dialyzer, and is capable of determining a dialysance using the equation ##EQU10## where:

D=the dialysance

Q_d =the dialysate flow rate

c_do =the concentration of the substance in the dialysate flowing out of the dialysate chamber

c_di =the concentration of the substance in the dialysate flowing into the dialysate chamber

c_bi =the concentration of the substance in the blood flowing into the blood chamber.

28. The device as recited in claim 25 wherein the at least one sensor comprises at least one of a conductivity sensor and an optical sensor.