Method of determining a parameter indicative of the progress of an extracorporeal blood treatment

• US 6,110,384 A
• Filed: 09/11/1998
• Issued: 08/29/2000
• Est. Priority Date: 12/09/1997
• Status: Expired due to Term

• Current Assignee: Industries Gambro
• Original Assignee: Gambro AB (Baxter International Inc.), Hospal Industrie
• Inventors: Sternby, Jan, Goux, Nicolas
• Primary Examiner(s): Drodge, Joseph W.
• Application Number:
  US09/152,071
• Time in Patent Office: 718 Days
• Field of Search: 210/85, 210/96.2, 210/321.7, 210/646, 210/647, 210/739, 210/929, 210/645, 210/746, 604/4, 604/5, 604/4.01, 604/5.01, 604/6.01, 604/6.09, 364/528.08
• US Class Current: 210/739
• 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 1/165 with a dialyser bypass on the dialysis fluid line
• 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
• CPC Class Codes: A61M 2230/65 Impedance, e.g. conductivity, capacity

Abstract

A method is disclosed for determining a parameter (D, K, Kt/v, Cbin) indicative of the effectiveness of an extracorporeal blood treatment carried out using a membrane exchanger. The method includes the steps of flowing through the exchanger a treatment liquid having a concentration characteristic (Cd) and of varying the value of the characteristic (Cd) upstream of the exchanger for a time at the end of which the characteristic (Cd) is returned to a nominal value. A plurality of values adopted by the characteristic (Cd) downstream of the exchanger in response to the upstream variation is measured and stored in memory. The area (Sout) of a downstream perturbation region is determined, which is bounded by a baseline and a curve representing the variation of the measured values with respect to time. Then, the parameter (D, K, Kt/v, Cbin) indicative of the effectiveness of the treatment is calculated using the area (Sin) beneath the upstream curve and an area beneath an upstream curve.

Claims

1. Method of determining a parameter indicative of the effectiveness of an extracorporeal blood treatment, the parameter being chosen from the group consisting of D, K, Kt/v, Cbin, the method comprising:

flowing blood through a first compartment of a membrane exchanger;

flowing treatment liquid through a second compartment of a membrane exchanger, the second compartment having an inlet connected to an upstream flow path and an outlet connected to downstream flow path;

controlling contents of the upstream flow path to cause an initial substantially constant conductivity value (Cd) in the upstream flow path;

measuring and storing in memory, data sufficient to define a downstream conductivity baseline;

purposefully inducing a conductivity perturbation in the second compartment by varying the conductivity value (Cd) in the upstream flow path for a discrete time period, after which discrete time period the upstream conductivity value is stabilized at the substantially constant conductivity value (Cd);

measuring and storing in memory, during the perturbation, a plurality of downstream perturbation conductivity values defining a downstream curve;

calculating with respect to the downstream baseline, an area bounded by the downstream curve; and

calculating, as a function of both the area bounded by the downstream curve and a known area associated with a corresponding upstream curve, the parameter indicative of the effectiveness of a treatment.

2. Method according to claim 1, wherein the perturbation is caused by setting conductivity valve (Cd), over a defined time interval, to a defined set value above or below a nominal value (Cd0in).

3. Method according to claim 1, wherein the perturbation is caused by setting the conductivity valve (Cd), over a first defined time interval, to a first defined set value above (or below) a nominal value (Cd0in), and setting the conductivity valve (Cd, over a second time interval, to a second set value below (or above) the nominal value (Cd0in).

4. Method according to claim 3, further comprising, choosing a duration of the second time interval as well as an absolute value of the second set value so that Cd resumes an initial value (Cd0out) downstream of the exchanger in a minimum amount of time.

5. Method according to one of claims 1 and 2 to 4, further comprising, prior to calculating the parameter indicative of the effectiveness of the extracorporeal treatment, determining the area associated with the upstream curve.

6. Method according to claim 5, further comprising prior to determining the area associated with the upstream curve, measuring a plurality of values adopted by Cd of the treatment liquid upstream of the exchanger during a time period tc-ta.

7. Method according to one of claims 1 and 2 to 4, further comprising, prior to varying the value of Cd:

giving the parameters of the perturbation a defined value, so that the area associated with the upstream curve is constant when predetermined parameters of the perturbation are compiled with;

determining and storing in memory the area associated with the upstream curve for a perturbation having the defined parameters.

8. Method according to claim 1, further comprising determining the area associated with the upstream (or downstream) curve by:

determining an equation for the curve representing a variation, as a function of time, in the measured values of Cd upstream (or downstream) of the exchanger;

calculating an integral of the equation between a start and an end of the variation in the value of Cd; and

subtracting from the integral of the equation an area equal to a product of a duration of the perturbation and a nominal value of Cd.

9. Method according to claim 1, wherein the area bounded by at least one of the upstream curve and the downstream curve is determined by:

measuring a value of Cd at time intervals Δ

t throughout a duration of the perturbation;

calculating a series of elementary areas by multiplying each measured value, decreased by a nominal value (Cd0in) (or by the initial value Cd0out) of Cd, by the time interval Δ

t; and

summing the elementary areas.

10. Method according to claim 1, wherein the conductivity value (Cd) is varied during the perturbation by varying the concentration in the treatment liquid of a substance present in both the treatment liquid and the blood, and in that the dialysance D of the exchanger for the substance is calculated by means of the formula:

space="preserve" listing-type="equation">D=(Qd+Quf)×

(1-Sout/Sin)

where Qd is a flow rate of the treatment liquid and Quf is an ultrafiltration flow rate.

11. Method according to claim 10, characterized in that the substance is sodium.

12. Method according to claim 1, wherein the conductivity value (Cd) is varied during the perturbation by varying the concentration in the treatment liquid of a substance present in the treatment liquid and in the blood and in that a concentration Cbin of the substance in the patient'"'"'s blood upstream of the exchanger is calculated by means of the formula:

##EQU12##

13. Method according to claim 10 or 12, wherein the perturbation is caused by modifying a discharge rate of a pump associated with a treatment-liquid generator in which a concentrated solution is mixed with water or with a dilute solution, in order to prepare the treatment liquid.

14. Method according to claim 1, wherein the conductivity value (Cd) is varied during the perturbation by varying the concentration in the treatment liquid of a substance present in the blood and absent from the treatment liquid, and in that the clearance K of the exchanger for the substance is calculated by means of the formula:

space="preserve" listing-type="equation">K=(Qd+Quf)×

(1-Sout/Sin)

where Qd is the flow rate of the treatment liquid and Quf is an ultrafiltration flow rate.

15. Method according to claim 14, characterized in that the substance is urea.

16. Method according to claim 1, wherein the conductivity value (Cd) is varied during the perturbation by varying the concentration in the treatment liquid of a substance present in the blood and absent from the treatment liquid and in that a concentration Cbin of the substance in the patient'"'"'s blood upstream of the exchanger is calculated by means of the formula:

##EQU13##

17. Method according to one of claims 10, 11, 12 or 16, characterized in that the perturbation is caused by injecting a volume of a liquid containing the substance into the treatment liquid upstream of the exchanger.

18. Method according to claim 17, characterized in that a defined volume of the substance is injected into the treatment liquid so that the area associated with the upstream curve can be predetermined.

19. Method of claim 1, wherein the known area is calculated from measurements and stored in memory.

20. Method of claim 1, further including measuring and storing in memory an upstream baseline conductivity value, and measuring and storing in memory, during the upstream baseline conductivity value punctuated by a curve defined by the stored upstream perturbation conductivity values area used to obtain the known area.