Method of in-vivo determination of hemodialysis parameters and a device for carrying out the method

• US 6,217,539 B1
• Filed: 11/26/1997
• Issued: 04/17/2001
• Est. Priority Date: 11/30/1996
• 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: Goldau, Rainer
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Bianco, Patricia
• Application Number:
  US08/979,401
• Time in Patent Office: 1,238 Days
• Field of Search: 604/4, 604/28-9, 604/4.01, 604/5.01, 604/6.1, 604/6.09, 128/898, 600/363, 600/366, 600/454, 210/645-47, 210/650, 210/739
• US Class Current: 604/4.01
• 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 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• CPC Class Codes: A61M 1/3607 Regulation parameters
• 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 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2230/65 Impedance, e.g. conductivity, capacity

Abstract

To be able to optimize the hemodialysis treatment process, in-vivo determination of important parameters, such as the exchange efficiency of the dialyzer, represented by the dialysance or clearance, is desirable. Mathematical quantification of the blood purification processes on the basis of measurement technology is especially important. Important measured quantities and operands for the determination of the desired parameter are usually the dialysate flow and the blood flow (Qd, Qb), the inlet and outlet concentrations (cdi, cdo) of the dialysis fluid and the electrolyte transfer rate derived from it as well as the formulation of the mass balance in the dialyzer.

This invention provides that at least one of the two flow rates (Qb, Qd) is set at a minimum of two different values in the measurement interval, and corresponding measured quantities are derived, from which the parameter to be determined is obtained together with the above-mentioned conventional measured quantities and operands as well as on the basis of equations between the dialyzer characteristics that describe the mass exchange and a conditional equation. At a known effective blood flow (Qb), this may be, for example, the blood concentration at the inlet (cbi), from which the dialysance can then be determined. When the cbi value is known, the effective blood flow and thus the hematocrit can be determined.

Claims

1. A method for the in vivo determination of a hemodialysis parameter involving a dialyzer having a semipermeable separation layer between a blood chamber and a dialysate chamber, comprising the steps of providing blood to the blood chamber and dialysate to the dialysate chamber, varying the dialysance by varying the flow rate of at least one of the blood flow and dialysate flow, the blood flow and the dialysate flow, respectively being varied over at least two respective predetermined flow rates during a measuring interval, obtaining the concentration of a substance in the dialysate upstream and downstream of the dialysate chamber at the predetermined flow rates, and determining a hemodialysis parameter from the obtained concentrations of the substance and the at least two predetermined flow rates using relationships between the characteristic quantities of the dialyzer describing the substance exchange.

2. The method of claim 1, further comprising setting the blood flow rate to at least two different predetermined values, and deriving a signal for the effective blood flow from the prevailing blood flow.

3. The method of claim 1, further comprising setting the blood flow rate to at least two different predetermined values, and deriving a signal from the prevailing blood flow rate for a measured quantity linked to the effective blood flow at least in the measuring interval by way of a known equation.

4. The method of claim 1, further comprising setting the dialysate flow rate to at least two different predetermined values, and measuring the substance concentration at each dialysate flow rate.

5. The method of claim 1, further comprising maintaining a constant dialysate inlet concentration.

6. The method of claim 1, further comprising varying the dialysate inlet concentration within a predetermined range during the measuring interval.

7. The method of claim 1, wherein the effective blood flow is measured, and the blood inlet concentration is determined.

8. The method of claim 1, wherein the blood inlet concentration is measured, and the effective blood flow is determined.

9. The method of claim 7, further comprising determining the dialysance or the clearance of the dialyzer from the blood inlet concentration.

10. A method for the in vivo determination of a hemodialysis parameter involving a dialyzer having a semipermeable separation layer between a blood chamber and a dialysate chamber, comprising the steps of;

providing blood to the blood chamber and dialysate to the dialysate chamber;

varying the dialysance by varying the flow rate of at least one of the blood flow and dialysate flow, the blood flow and the dialysate flow being respectively varied over at least two respective predetermined flow rates during a measuring interval;

obtaining the concentration of a substance in the dialysate upstream and downstream of the dialysate chamber at the predetermined flow rates; and

determining the hemodialysis parameter from the measured quantities cd, cb, Qd, Qb, the exchange surface A of the dialyzer, and the specific membrane diffusion resistance R, according to the equation;

$\left[\frac{\mathrm{k1}·<br><br>\mathrm{cbi1}-\mathrm{cdo2}}{\left(\mathrm{k1}·<br><br>\mathrm{cbi1}-\left(\mathrm{cdo2}·<br><br>n·<br><br>q\right)-\left(\mathrm{k2}·<br><br>\mathrm{cdi}·<br><br>\left(n·<br><br>q-1\right)\right)\right)<br><br>\text{\hspace{1em}<br><br>}}\right]-{\left[\frac{\mathrm{cbi1}-\mathrm{cdo1}}{\mathrm{cbi1}-\mathrm{cdo1}·<br><br>q-\left(\mathrm{cdi1}·<br><br>\left(q-1\right)\right)}\right]}^{\mathrm{k3}·<br><br>B}=0$

with $n=\frac{\mathrm{Qd2}·<br><br>\mathrm{Qb1}}{\mathrm{Qd1}·<br><br>\mathrm{Qb2}}$$q;<br><br>=\frac{\mathrm{Qd1}}{\mathrm{Qb1}},\text{\hspace{1em}<br><br>}<br><br>n·<br><br>q=\frac{\mathrm{Qd2}}{\mathrm{Qb2}}$$B=\frac{\mathrm{Qd1}·<br><br>\left(n·<br><br>q-1\right)}{\mathrm{Qd2}·<br><br>\left(q-1\right)}$

and the transition constants $\mathrm{k1};<br><br>=\frac{\mathrm{cbi2}}{\mathrm{cbi1}}$$\mathrm{k2};<br><br>=\frac{\mathrm{cdi2}}{\mathrm{cdi1}}$$\mathrm{k3};<br><br>=\frac{\mathrm{A2}·<br><br>\mathrm{R1}}{\mathrm{A1}·<br><br>\mathrm{R2}}$

wherein cd is a concentration in the dialysate;

cb is a concentration in the blood;

Qd, is a dialysate flow and Qb is an effective blood flow.

11. A method for the in vivo determination of a hemodialysis parameter involving a dialyzer having a semipermeable separation layer between a blood chamber and a dialysate chamber, comprising;

providing blood to the blood chamber and dialysate to the dialysate chamber;

varying the dialysance by varying the flow rate of at least one of the blood flow and dialysate flow, the blood flow and the dialysate flow being respectively varied over at least two respective predetermined flow rates during a measuring interval;

obtaining the concentration of a substance in the dialysate upstream and downstream of the dialysate chamber at the predetermined flow rates;

determining a hemodialysis parameter from the obtained concentrations of the substance and the at least two predetermined flow rates using relationships between the characteristic quantities of the dialyzer describing the substance exchange;

measuring the blood inlet concentration and determining the effective blood flow, and

determining the hematocrit from the effective blood flow and a measured value for the whole blood flow, according to the formula;

$\mathrm{HCT}=1-\frac{\mathrm{Qb}}{\mathrm{Qvb}}$

wherein Qb is an effective blood flow and Qvb is a blood flow.

12. A device for the in vivo determination of hemodialysis parameters comprising a dialyzer having a semipermeable separation layer separating a blood chamber from a dialysate chamber, the blood chamber adapted for connection to a patient by a blood circulation system having a blood pump, the dialysate chamber adapted for connection to a dialysate circulation system having a dialysate pump, at least one of the blood circulation system and the dialysate circulation system having a device for varying the dialysance of the dialyzer by varying the respective fluid flow rate, the respective fluid flow rate being variable over at least two rates, a sensor adapted to measure the concentration of dialysate at the outlet of the dialysate chamber, means connected to the sensor for setting at least one of the blood and dialysate flow rates to at least two predetermined flow rates, and means for determining a hemodialysis parameter from the measured substance concentrations at the at least two predetermined flow rates, and using relationships between the characteristic quantities of the dialyzer describing the substance exchange.

13. The device of claim 12, wherein the sensor is selected from the group consisting of a conductivity sensor and an optical sensor.