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

• US 6,691,040 B2
• Filed: 12/01/2000
• Issued: 02/10/2004
• Est. Priority Date: 12/02/1999
• Status: Expired due to Term

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.)
• Original Assignee: Hospal AG
• Inventors: Paolini, Francesco, Bosetto, Antonio
• Primary Examiner(s): Allen, Marianne P.
• Assistant Examiner(s): Mahatan, Channing S.
• Application Number:
  US09/726,484
• Publication Number:
  US 20010004523A1
• Time in Patent Office: 1,166 Days
• Field of Search: 210/739, 324/71.1, 702/19, 435/4
• US Class Current: 702/19
• 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 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• 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 2205/52 with memories providing a history of measured variating parameters of apparatus or patient

Abstract

A method for continuously determining a parameter (D, Cbin, K, Kt/V) indicative of an extracorporeal blood treatment includes flowing patient'"'"'s blood and a treatment liquid flow on opposite sides of a semipermeable membrane. The treatment liquid has a characteristic (Cd) associated with the effectiveness of the treatment flow through the exchanger. A succession of variations are caused in the characteristic (Cd) upstream of the exchanger, and a plurality of values (Cdin1 . . . Cdinj . . . Cdinp) of the characteristic (Cd) upstream of the exchanger are continuously stored in memory. Similarly, plurality of values (Cdout1 . . . Cdoutj . . . Cdoutp) adopted by the characteristic (Cd) downstream of the exchanger are continuously stored in memory. From the stored values, the effectiveness of the treatment is calculated using a mathematical model.

Claims

1. Method for continuously determining a parameter indicative of effectiveness of an extracorporeal blood treatment, the treatment including flowing a patient'"'"'s blood and a treatment liquid, one on either side of a semipermeable membrane of a membrane exchanger, the method comprising:

storing in memory a mathematical model of the influence of a characteristic of the treatment liquid on the effectiveness of the treatment, the mathematical model having at least one coefficient comprising a parameter indicative of the effectiveness of the extracorporeal blood treatment;

flowing, through the exchanger, a treatment liquid;

varying a value of the characteristic upstream of the exchanger;

continuously storing in memory a first plurality of values of the characteristic upstream of the exchanger;

measuring and continuously storing in memory a second plurality of values adopted by the characteristic downstream of the exchanger in response to said varying the characteristic upstream of the exchanger; and

computing, by means of the mathematical model and each time that a predetermined number of new values of the characteristic downstream of the exchanger have been stored, a parameter indicative of the effectiveness of the extracorporeal blood treatment from a first series of values of the characteristic upstream of the exchanger and from a second series of values of the characteristic downstream of the exchanger.

2. Method according to claim 1, wherein said computing comprises computing the parameter indicative of the effectiveness of the extracorporeal blood treatment each time that a new value of the characteristic downstream of the exchanger has been stored.

3. Method according to either of claims 1 and 2, wherein the second series of values of the characteristic downstream of the exchanger comprises a most recent value stored in memory.

4. Method according to claim 1, wherein the second series of values of the characteristic downstream of the exchanger comprises a predetermined number of successive values.

5. Method according to claim 1, further comprising establishing a correspondence between each value of the second series of values and a value of the first series of values, the value of the second series of values being shifted over time with respect to the corresponding value of the first series of values by a hydraulic delay equal to the time taken by a liquid specimen to flow through a treatment liquid circuit connected to the exchanger, between a point lying upstream of the exchanger and a point lying downstream of the exchanger.

6. Method according to claim 5, further comprising determining the value of the hydraulic delay.

7. Method according to claim 6, wherein the hydraulic delay is one of the coefficients of the mathematical model and wherein said determining the value of the hydraulic delay comprises:

computing, by means of the mathematic model, for each value of the first series of values, a corresponding value of the characteristic downstream of the exchanger; and

determining a value of the hydraulic delay for which the computed values of the characteristic downstream of the exchanger are the closest to the corresponding measured values downstream of the exchanger.

8. Method according to one of claims 5 to 7, wherein said computing a parameter indicative of the effectiveness of the extracorporeal blood treatment comprises:

computing, by means of the mathematical model, for each value of the first series of values, a corresponding value of the characteristic downstream of the exchanger; and

determining a value of the parameter for which the computed values of the characteristic downstream of the exchanger are the closest to the corresponding measured values downstream of the exchanger.

9. Method according to claim 8, wherein the mathematical model is linear and wherein said determining the optimum value of the parameter comprises determining a value of the parameter for which the sum of the squares of the differences between the measured values and the corresponding computed values of the characteristic downstream of the exchanger is the least.

10. Method according to claim 1, wherein said varying the characteristic upstream of the exchanger comprises adjusting the characteristic as a function of a variation of at least one of a parameter of a device intended for implementing the treatment and a parameter of the patient, the varied parameter remaining within a range of permissible values.

11. Method according to claim 10, wherein the parameter of the patient is a relative variation in blood volume of the patient.

12. Method according to claim 1, wherein said varying the characteristic upstream of the exchanger comprises storing in memory, before the treatment, a rule of variation of the characteristic upstream of the exchanger.

13. Method according to claim 12, wherein the rule of variation entails regular alternation of an increase and of a decrease in the characteristic of a defined amount.

14. Method according to claim 1, further comprising preparing the treatment liquid, wherein varying the characteristic upstream of the exchanger is inherent in perturbations associated with the preparation of the treatment liquid.

15. Method according to claim 1, further comprising measuring the first plurality of values of the characteristic upstream of the exchanger.

16. Method according to claim 1, wherein the characteristic of the treatment liquid influences the exchanges across the membrane of the exchanger, and wherein the mathematical model of the influence of the characteristic on the effectiveness of the treatment is a mathematical model of the exchanges across the membrane of the exchanger.

17. Method according to claim 16, wherein the characteristic of the treatment liquid influences ion and solute exchanges or with heat exchanges across the membrane of the exchanger.

18. Method according to claim 17, wherein the parameter indicative of the effectiveness of an extracorporeal blood treatment is dialysance, and wherein the mathematical model is defined by the following equations:

19. Method according to claim 17, wherein the variation imposed on the characteristic of the treatment liquid is periodic and comprises computing an amplitude of variation in the conductivity upstream of the exchanger from the first series of values and an amplitude of variation in the conductivity downstream of the exchanger from the second series of values.

20. Method according to claim 19, wherein the parameter indicative of the effectiveness of an extracorporeal blood treatment is the dialysance, and wherein the mathematical model is defined by the following equation:

$\mathrm{Dr}=\frac{D}{\mathrm{Qd}}=1-\frac{<br><br>\mathrm{Cdout}<br><br>}{<br><br>\mathrm{Cdin}<br><br>}$

in which;

Qd is the flow rate of the treatment liquid;

D is the dialysance;

|Cdin| is the amplitude of variation in the conductivity upstream of the exchanger; and

|Cdout| is the amplitude of variation in the conductivity downstream of the exchanger.

21. Method according to claim 20, further comprising computing average conductivity upstream of the exchanger from the second series of values.

22. Method according to claim 21, wherein the parameter indicative of the effectiveness of an extracorporeal blood treatment is ion concentration of the blood upstream of the exchanger, and wherein the mathematical model is defined by the following equation:

$C<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{bin}=\frac{1}{\mathrm{Dr}}\times <br><br>\mathrm{CdoutM}-\frac{\left(1-\mathrm{Dr}\right)}{\mathrm{Dr}}\times <br><br>\mathrm{CdinM}$

in which;

Cbin is ion concentration of the blood upstream of the exchanger;

CdinM is the average conductivity upstream of the exchanger; and

CdoutM is average conductivity downstream of the exchanger.