Process and device for determining hemodialysis parameters

• US 6,187,199 B1
• Filed: 04/26/1999
• Issued: 02/13/2001
• Est. Priority Date: 01/24/1997
• 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: Goldau, Rainer
• Primary Examiner(s): Drodge, Joseph W.
• Application Number:
  US09/155,276
• Time in Patent Office: 659 Days
• Field of Search: 210/85, 210/94, 210/96.1, 210/96.2, 210/143, 210/149, 210/175, 210/321.71, 210/646, 210/647, 210/739, 210/745, 210/746, 210/93, 210/742, 604/4.01, 604/5.01, 604/6.01, 604/6.11, 604/6.14, 73/614.1, 436/79, 436/147, 436/150
• 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 1/1617 using measurements made during a temporary variation of a characteristic of the fresh dialysis fluid
• 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 2205/3368 Temperature
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient

Abstract

A method is described for determining hemodialysis parameters during an extracorporeal blood treatment according to which the blood to be treated in an extracorporeal circulation flows through the blood chamber of a dialyzer divided by a semipermeable membrane into the blood chamber and a dialysate chamber, and dialysate in a dialysate path flows through the dialysate chamber of the dialyzer. According to the method pursuant to the invention, the hemodialysis parameter can also be determined when no balanced state has yet been established. The method according to the invention is based on the response of the dialyzer to a pulse function as inlet signal (pulse response) from the course over time of the physical or chemical characteristic quantity of the dialysate upstream and downstream of the dialyzer. The hemodynamic parameter is then determined from the pulse response of the dialyzer.

Claims

1. A method of determining a hemodialysis parameter during hemodialysis comprising the steps of:

providing blood to be treated to a blood chamber in a dialyzer, the dialyzer being divided by a semipermeable membrane into the blood chamber and a dialysate chamber;

providing dialysate to the dialysate chamber through a dialysate path, wherein the dialysate enters the dialysate chamber through a dialysate chamber inlet and exits the dialysate chamber through a dialysate chamber outlet;

changing a characteristic quantity of the dialysate upstream of the dialysate chamber inlet;

measuring the characteristic quantity of the dialysate downstream of the dialysate chamber outlet;

determining a pulse response of the dialyzer by comparing the measurement of the characteristic quantity of the dialysate downstream to the change in the characteristic quantity of the dialysate upstream; and

determining the hemodialysis parameter using the pulse response.

2. The method of claim 1 wherein the characteristic quantity of the dialysate is a dialysate substance concentration.

3. The method of claim 2 wherein the characteristic quantity of the dialysate is the sodium (Na) concentration.

4. The method of claim 3 wherein sodium concentration is changed by providing a bolus of sodium upstream of the dialysate chamber.

5. The method of claim 4 further comprising a control unit adapted to signal the release of a bolus of sodium and further comprising the step of:

providing a signal from the control unit causing the release of a bolus of sodium into the dialysate upstream of the dialysate chamber.

6. The method of claim 1 wherein a first measuring device is provided upstream of the dialysate chamber and a second measuring device is provided downstream of the dialysate chamber, wherein the first and second measuring devices measure the characteristic quantity of the dialysate, and further comprising the steps of:

measuring the characteristic quantity of the dialysate upstream of the dialysate chamber; and

determining the pulse response of the dialyzer by comparing the measurement of the characteristic quantity of the dialysate upstream of the dialyzer to the measurement of the characteristic quantity of the dialysate downstream of the dialyzer.

7. The method of claim 6 wherein the first and second measuring devices are selected from the group consisting of a conductivity sensor and an optical sensor.

8. The method of claim 6 wherein the characteristic quantity of the dialysate is dialysate temperature, the first and second measuring devices are temperature sensors, and the change in the temperature is provided by a heating device provided in the dialysate path upstream of the dialysate chamber.

9. The method of claim 8 further comprising a control unit adapted to signal the heating arrangement to produce a dialysate temperature surge and further comprising the step of:

providing a signal from the control unit and thereby causing a temperature surge in the dialysate upstream of the dialysate chamber.

10. The method of claim 6 further comprising the steps of:

determining a characteristic quantity of the dialysate upstream of the dialysate chamber corresponding to a stationary state, of the quantity (cdi_stat) using the pulse response of the dialyzer and a characteristic quantity of the dialysate upstream from the dialysate chamber in the following equation;

${\mathrm{cdi}}_{\mathrm{stat}}<br><br>\left(t\right)={\int <br><br>}_{t-t_g}^{t+t_g}<br><br>\mathrm{cdi}<br><br>\left(t^{\mathrm{\prime <br><br>}}-t_{\mathrm{tot}}\right)<br><br>g<br><br>\left(t-t^{\mathrm{\prime <br><br>}}\right)<br><br><br><br>t^{\mathrm{\prime <br><br>}}$

 

where t is the length of time for a pulse response downstream of the dialysate chamber to decline or rise below half the measuring accuracy from its maximum, t is a given point in time and g(t−

t′

) is the pulse response representing a weighting function which indicates what portion of the dialysate outlet concentration cdo(t) at point in time (t−

t_tot) a given value of the dialysate inlet concentration cdi(t′

−

t_tot) has, where t′

lies in the range (t−

t_g t+t_g) and t_tot is the mean propagating time of the change in the characteristic quantity of the dialysate upstream of the dialysate chamber from the dialyzer inlet to the dialyzer outlet; and

determining the hemodialysis parameter using the characteristic quantity of the dialysate upstream of the dialysate chamber corresponding to a stationary state.

11. The method of claim 10 further comprising the steps of:

changing the characteristic quantity of the dialysate upstream of the dialysate chamber over a predetermined time interval;

measuring the characteristic quantity of the dialysate downstream of the dialysate chamber at first and second measurement times; and

determining the dialysance D of the characteristic quantity of the dialysate by determining the difference between the differences of the characteristic quantity of the dialysate upstream of the dialysate chamber corresponding to a stationary state (cdi_stat) a and the measured characteristic quantity of the dialysate downstream of the dialysate chamber at the first and second measurement times, dividing by the difference between the characteristic quantity of the dialysate upstream of the dialysate chamber corresponding to a stationary state at the time of the first measurement and the characteristic quantity of the dialysate upstream of the dialysate chamber corresponding to a stationary state at the time of the second measurement, and multiplying by the dialysate flow (Q_d).

12. The method of claim 1 further comprising the steps of:

generating an inlet signal from the change in the characteristic quantity of the dialysate upstream of the dialysate chamber;

generating an outlet signal from the measurement of the characteristic quantity of the dialysate downstream of the dialysate chamber;

determining the pulse response using the inlet signal and outlet signal.

13. The method of claim 12 further comprising the steps of:

conveying the inlet signal and outlet signal to a storage unit that stores inlet signals and outlet signals in chronological order; and

conveying the stored inlet signals and outlet signals to a microprocessor, which compares the inlet signals and outlet signals to determine the pulse response and determines the hemodialysis parameter using the pulse response.

14. The method of claim 1 wherein the hemodialysis parameter being determined is the dialysance of the characteristic quantity of the dialysate and further comprising the steps of:

determining the integral of the pulse response; and

comparing the integral over the pulse response to predetermined values of the integral over the pulse response corresponding to specific dialysance values for the characteristic quantity of the dialysate.

15. A method of determining a hemodialysis parameter during hemodialysis comprising the steps of:

providing blood to be treated to a blood chamber in a dialyzer, the dialyzer being divided by a semipermeable membrane into the blood chamber and a dialysate chamber;

providing dialysate to the dialysate chamber through a dialysate path, wherein the dialysate enters the dialysate chamber through a dialysate chamber inlet and exits the dialysate chamber through a dialysate chamber outlet;

providing a pulse function upstream of the dialysate chamber inlet;

generating an inlet signal from the pulse function provided upstream of the dialysate chamber inlet;

generating an outlet signal from the pulse function by measuring the downstream response of the dialyzer to the pulse function;

determining a pulse response of the dialyzer to the pulse function using the inlet signal and outlet signal; and

determining the hemodialysis parameter using the pulse response.

16. A device for determining a hemodialysis parameter comprising (a) a dialyzer divided by a semipermeable membrane into a blood chamber having an inlet and an outlet and a dialysate chamber having an inlet and an outlet, (b) an extracorporeal blood circulation unit connected to the blood chamber for providing blood to the blood chamber, (c) a dialysate path connected to the dialysate chamber for providing dialysate to the dialysate chamber, (d) means for changing a characteristic quantity of the dialysate in the dialysate path upstream from the dialysate chamber in a predetermined time interval and generating an inlet signal for the change of the quantity (e) means for measuring the characteristic quantity of the dialysate in the dialysate path downstream from the dialysate chamber and generating an outlet signal from the measured quantity, (f) a storage unit adapted to receive and store the inlet signal and outlet signal in chronological sequence, and (g) a microprocessor connected to the storage unit that is adapted for determining the hemodialysis parameter, wherein the microprocessor determines a pulse response of the dialyzer by comparing the inlet signal and outlet signal and determines the hemodialysis parameter using the pulse response.

17. The device of claim 16 further comprising a means of measuring the characteristic quantity of the dialysate upstream of the dialysate chamber and generating an inlet signal from the change in the characteristic quantity of the dialysate upstream of the dialysate chamber.

18. The device according to claim 17 wherein the microprocessor is adapted to determine the characteristic quantity of the dialysate upstream of the dialysate chamber corresponding to a stationary state (cdi_stat) using the pulse response of the dialyzer, the measured values of the characteristic quantity upstream of the dialysate chamber and the measured values for the characteristic quantity downstream of the dialysate chamber, and wherein the hemodialysis parameter is determined by comparing the calculated value for cdi_stat to known values of the hemodialysis parameter corresponding to the calculated cdi_stat value.

19. The device according to claim 16 wherein the microprocessor further comprises an integrator for determining the integral of the pulse response of the dialyzer and a means for determining the dialysance D of the hemodialysis parameter by comparing the calculated integral of the pulse response to known dialysance values corresponding to the calculated value.

20. The device of claim 16 wherein the means for changing the characteristic quantity of the dialysate upstream of the dialysate chamber is a means for changing the substance concentration.

21. The device of claim 20 wherein the means for changing the substance concentration is a means for providing a bolus of sodium (Na) to the dialysate.

22. The device of claim 20 wherein the means for measuring the characteristic quantity of the dialysate upstream and the means for measuring the characteristic quantity of the dialysate downstream of the dialysate chamber are selected from the group consisting of:

conductivity sensors and optical sensors.

23. The device of claim 16 wherein the means for changing the characteristic quantity of the dialysate upstream of the dialysate chamber is a means for changing the temperature of the dialysate.

24. The device of claim 23 wherein the means for measuring the characteristic quantity of the dialysate upstream and the means for measuring the characteristic quantity of the dialysate downstream of the dialysate chamber are thermometers.