Method for the determination of a significant parameter of the progess of an extracorporeal treatment of blood

• US 5,567,320 A
• Filed: 12/16/1994
• Issued: 10/22/1996
• Est. Priority Date: 12/17/1993
• Status: Expired due to Term

• Current Assignee: Gambro Hospal Schweiz AG
• Original Assignee: Hospal AG
• Inventors: Goux, Nicolas, Bene, Bernard
• Primary Examiner(s): Drodge, Joseph W.
• Application Number:
  US08/358,175
• Time in Patent Office: 676 Days
• Field of Search: 210/96.1, 210/96.2, 210/645, 210/646, 210/647, 210/739, 210/929, 364/413.01, 364/413.02, 364/413.03, 364/413.07, 364/413.11, 604/4-6, 604/29, 128/691, 128/692
• US Class Current: 210/739
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• 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 2205/52 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 for determining a significant parameter (Cb, D, K, Kt/V) of the progress of an extracorporeal blood treatment carried-out using a membrane exchanger, includes the steps of successively circulating three treatment fluids through the exchanger. Each fluid has a characteristic Cd linked to at least one of the significant parameters of the treatment (Cb, D, K, Kt/V). The value of the characteristic in the first fluid upstream of the exchanger is different from the value of the characteristic in the second fluid upstream of the exchanger, the latter being itself different from the value of the characteristic in the third fluid upstream of the exchanger. Two values for each of the three treatment fluids are measured, respectively upstream and downstream of the exchanger, and at least one value of at least one significant parameter of the progress of the treatment (Cb, D, K, Kt/V) is calculated from the measured values.

Claims

1. A method for determining a significant parameter (Cb, D, K, Kt/V) of the progress of an extracorporeal blood treatment carried-out using an apparatus for treating blood, the apparatus being provided with means for circulating blood of a patient and a treatment fluid on opposing sides of a semipermeable membrane in a membrane exchanger, the method comprising the steps of:

circulating through the exchanger a first treatment fluid (d1), having a characteristic (Cd) linked to at least one of the significant treatment parameters (Cb, D, K, Kt/V);

measuring two, values (Cd1in, Cd1out) of the characteristic (Cd) in the first treatment fluid (d1), respectively upstream and downstream of the exchanger;

circulating through the exchanger a second treatment fluid (d2), having the characteristic (Cd) with a value (Cd2in) upstream of the exchanger different from the value of (Cd1in);

measuring two values (Cd2in, Cd2out) of the characteristic (Cd) in the second treatment fluid (d2), respectively upstream and downstream of the exchanger;

circulating through the exchanger, before the characteristic (Cd) of the second fluid (d2) has reached a stable value downstream of the exchanger, a third treatment fluid (d3) having the characteristic (Cd), a value (Cd3in) of the characteristic (Cd) in the third fluid (d3) upstream of the exchanger being different from the value of (Cd2in);

measuring two values (Cd3in, Cd3out) of the characteristic (Cd) in the third fluid (d3) respectively upstream and downstream of the exchanger; and

calculating, using the measured values of (Cd1in), (Cd1out), (Cd2in), (Cd2out), (Cd3in), and (Cd3out), at least one value of at least one significant parameter of the progress of the treatment (Cb, D, K, Kt/V).

2. A method according to claim 1, wherein, upstream of the exchanger, the value of the characteristic (Cd) in the first fluid (d1) is chosen less than the value of the characteristic (Cd) in the second fluid (d2), which is itself chosen less than the value of the characteristic (Cd) in the third fluid (d3).

3. A method according to claim 1, wherein, upstream of the exchanger, the value of the characteristic (Cd) in the first fluid (d1) is chosen greater than the value of the characteristic (Cd) in the second fluid (d2), which is itself chosen greater than the value of the characteristic (Cd) in the third fluid (d3).

4. A method according to claim 1, wherein, upstream of the exchanger, the value of the characteristic (Cd) in the first fluid (d1) is chosen less than the value of the characteristic (Cd) in the second fluid (d2), which is itself chosen greater than the value of the characteristic (Cd) in the third fluid (d3).

5. A method according to claim 1, wherein, upstream of the exchanger, the value of the characteristic (Cd) in the first fluid (d1) is chosen greater than the value of the characteristic (Cd) in the second fluid (d2), which is itself chosen less than the value of the characteristic (Cd) in the third fluid (d3).

6. A method according to claim 1, wherein the value of the characteristic (Cd) in the second fluid (d2) upstream of the exchanger is chosen less than or greater than the value of the characteristic (Cd) in the first fluid (d1) upstream of the exchanger, according to the sign of the difference (Cdin1-Cdout1) between the measured values of the characteristic (Cd) in the first fluid (d1) upstream and downstream of the exchanger.

7. A method according to claim 1, wherein the value of (Cd3in) differs from the value of (Cd2in), according to a sign of a difference (Cd1in-Cd1out) between the measured values of the characteristic (Cd) in the first fluid (d1) upstream and downstream of the exchanger and/or according to a sign of a difference (Cdin2-Cdout2) between the measured values of the characteristic (Cd) in the second fluid (d2) upstream and downstream of the exchanger.

8. A method according to claim 1, wherein the value of (Cd3in) is chosen as a function of an approximate value of blood sodium concentration (Cb'"'"'), calculated as a function of the measured values (Cd1in, Cd1out, Cd2in, Cd2out) of the first and second dialysis fluids (d1, d2).

9. A method according to claim 1, wherein the measured characteristic (Cd) is chosen from the group consisting of sodium concentration and conductivity, and a parameter of the treatment which is calculated is the concentration of sodium (Cb) in the blood upstream of the exchanger.

10. A method according to claim 9, wherein the concentration of sodium (Cb) in the blood upstream of the exchanger is calculated according to the formula:

##EQU5##

11. A method according to claim 1, wherein the measured characteristic (Cd) is chosen from the group consisting of sodium concentration and conductivity and wherein a parameter of the treatment which is calculated is the dialysance (D).

12. A method according to claim 11, wherein the dialysance (D) is calculated according to the formula:

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

A

where

Qd is a flow rate of the dialysis fluid,

Quf is a rate of ultrafiltration, and ##EQU6##

13. A method according to claim 11, wherein a clearance (K) for a blood metabolite is deduced from the dialysance (D) using a predetermined correspondence table.

14. A method according to claim 13, wherein a parameter of the treatment which is calculated is a dose of dialysis (Kt/V), where t is a treatment time elapsed and V is a total volume of water for the patient.

15. A method according to claim 1, wherein, at the step of calculating at least a value of at least one significant parameter of the progress of the treatment (Cb, D, K, Kt/V), for the measured values Cd1in, Cd2in, Cd3in of the characteristic (Cd) in the first (d1), the second (d2) and the third (d3) treatment fluids, there are used corresponding reference values (Cd1in_REF, Cd2in_REF, Cd3in_REF), which are entered before each treatment session in a control unit controlling the preparation of the treatment fluids.

16. A method for determining a significant parameter (Cb, D, K, Kt/V) of the progress of an extracorporeal blood treatment carried-out using an apparatus for treating blood, the apparatus being provided with means for circulating blood of a patient and a treatment fluid on opposing sides of a semipermeable membrane in a membrane exchanger, the method comprising the steps of:

circulating through the exchanger a first treatment fluid (d1), having a characteristic (Cd) linked to at least one of the significant treatment parameters (Cb, D, K, Kt/V);

measuring two values (Cd1in, Cd1out) of the characteristic (Cd) in the first treatment fluid (d1), respectively upstream and downstream of the exchanger;

circulating through the exchanger a second treatment fluid (d2), having the characteristic (Cd) with a value (Cd2in) upstream of the exchanger different from the value of (Cd1in);

measuring two values (Cd2in, Cd2out) of the characteristic (Cd) in the second treatment fluid (d2), respectively upstream and downstream of the exchanger, whereby a time interval (t2-ta) between an instant (ta), when the second fluid (d2) is put into circulation in the exchanger, and an instant (t2), when the value (Cd2out) of the characteristic (Cd) in the second fluid is measured downstream of the exchanger, is chosen such that the characteristic (Cd) has not reached a stable value downstream of the exchanger at the instant (t2);

circulating through the exchanger before the characteristic (Cd) of the second fluid (d2) has reached a stable value downstream of the exchanger, a third treatment fluid (d3) having the characteristic (Cd), a value (Cd3in) of the characteristic (Cd) in the third fluid (d3) upstream of the exchanger being different from the value of (Cd2in);

measuring two values (Cd3in, Cd3out) of the characteristic (Cd) in the third fluid (d3) respectively upstream and downstream of the exchanger, whereby a time interval (t3-tb) between an instant (tb), when the third fluid (d3) is put into circulation in the exchanger, and an instant (t3), when the value (Cd3out) in the third fluid is measured downstream of the exchanger, is chosen such that the characteristic (Cd) has not reached a stable value downstream of the exchanger at the instant (t3); and

calculating, using the measured values of (Cd1in), (Cd1out), (Cd2in), (Cd2out), (Cd3in), and (Cd3out), at least one value of at least one significant parameter of the progress of the treatment (Cb, D, K, Kt/V).

17. A method for determining a significant parameter (Cb, D, K, Kt/V) of the progress of an extracorporeal blood treatment carried-out in an apparatus for treating blood, the apparatus being provided with means for circulating blood of a patient and a treatment fluid on opposing sides of a semipermeable membrane in a membrane exchanger, the method comprising the steps of:

circulating through the exchanger a first treatment fluid (d1) having a characteristic (Cd) linked to at least one of the significant parameters of the treatment (Cb, D, K, Kt/V);

measuring two values (Cd1in, Cd1out) of the characteristic (Cd) in the first treatment fluid (d1), respectively upstream and downstream of the exchanger;

circulating through the exchanger a second treatment fluid (d2), having the characteristic (Cd) with a value (Cd2in) upstream of the exchanger different from the value (Cd1in);

measuring two values (Cd2in, Cd2out) of the characteristic (Cd) in the second treatment fluid (d2), respectively upstream and downstream of the exchanger, whereby a time interval (t2-ta) between an instant (ta) when the second fluid (d2) is put into circulation in the exchanger, and an instant (t2) when the value (Cd2out) of the characteristic (Cd) in the second fluid is measured downstream of the exchanger, is chosen such that the characteristic (Cd) has not reached a stable value downstream of the exchanger at the instant (t2);

circulating through the exchanger before the characteristic (Cd) of the second fluid (d2) has reached a stable value downstream of the exchanger, a third treatment fluid (d3) having the characteristic (Cd), the value of the characteristic (Cd) in the third fluid (d3) upstream of the exchanger (Cd3in) being substantially equal to the value of (Cd2in);

measuring two values (Cd3in, Cd3out) of the characteristic (Cd) in the third fluid (d3) respectively upstream and downstream of the exchanger, whereby a time interval (t3-tb) between an instant (tb) when the third fluid (d3) is put into circulation in the exchanger, and an instant (t3), when the value (Cd3out) of the characteristic (Cd) in the third fluid is measured downstream of the exchanger, is chosen such that the characteristic (Cd) has not reached a stable value downstream of the exchanger at the instant (t3), and wherein the time intervals (t2-ta) and (t3-tb) are chosen to be substantially equal; and

calculating, using the measured values of (Cd1in), (Cd1out), (Cd2in), (Cd2out), (Cd3in), and (Cd3out), at least one value of at least one significant parameter of the progress of the treatment (Cb, D, K, Kt/V).

18. A method for determining a significant parameter (Cb, D, K, Kt/V) of the progress of an extracorporeal treatment of blood carried-out in an apparatus for treating blood, the apparatus being provided with means for circulating blood of a patient and a treatment fluid on opposing sides of the semipermeable membrane of a membrane exchanger, the method comprising the steps of:

circulating through the exchanger a first treatment fluid (d1) having a characteristic (Cd) linked to at least one of the significant treatment parameters (Cb, D, K, Kt/V);

measuring two values (Cd1in, Cd1out) of the characteristic (Cd) in the first treatment fluid (d1), respectively upstream and downstream of the exchanger;

circulating through the exchanger a second treatment fluid (d2) having the characteristic (Cd) with a value (Cd2in) upstream of the exchanger different from the value of (Cd1in);

measuring two values (Cd2in, Cd2out) of the characteristic (Cd) in the second treatment fluid (d2), respectively upstream and downstream of the exchanger;

circulating through the exchanger before the characteristic (Cd) of the second fluid (d2) has reached a stable value downstream of the exchanger, a third treatment fluid (d3) having the characteristic (Cd), a value (Cd3in) of the characteristic (Cd) in the third fluid (d3) upstream of the exchanger being different from the value of (Cd2in);

measuring two values (Cd3in, Cd3out) of the characteristic (Cd) in the third fluid (d3), respectively upstream and downstream of the exchanger;

calculating, using the measured values of (Cd1in), (Cd1out), (Cd2in), (Cd2out), (Cd3in), and (Cd3out), at least a first and a second value of a same significant parameter of the progress of the treatment (Cb, D, K, Kt/V);

comparing at least the first and the second calculated values; and

emitting an error signal if the calculated values do not confirm a predefined law.