Automatic apparatus for obtaining equilibration samples of dialysate

• US 5,849,179 A
• Filed: 05/20/1996
• Issued: 12/15/1998
• Est. Priority Date: 10/13/1992
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Emerson, Paul, Keshaviah, Prakash, Luhring, David A.
• Primary Examiner(s): Drodge, Joseph W.
• Application Number:
  US08/650,414
• Time in Patent Office: 939 Days
• Field of Search: 210/87, 210/96.2, 210/195.2, 210/369, 210/433.1, 210/434, 210/636, 210/644, 210/646, 210/929, 210/93, 210/424, 210/321.6, 604/4-63, 205/780.5, 204/403, 204/406, 204/409, 204/415, 436/108, 422/68.1
• US Class Current: 210/87
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• 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 1/1615 using measurements made at different flow rates
• CPC Class Codes: A61M 1/1619 Sampled collection of used dialysate, i.e. obviating the need for recovery of whole dialysate quantity for post-dialysis analysis
• CPC Class Codes: A61M 1/165 with a dialyser bypass on the dialysis fluid line
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 2202/0498 Urea
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: Y10S 210/929 Hemoultrafiltrate volume measurement or control processes

Abstract

An improved on-line, real time hemodialysis monitoring system for hemodialysis treatment, quantitates the rate and amount of a constituent, such as urea, removed during the hemodialysis treating by measuring the constituent concentrations as a function of time in the spent dialysate effluent from a hemodialysis machine. A quantity of the spent dialysate effluent is removed from the dialysate effluent waste line periodically for testing. A urea concentration time profile can be analyzed to determine the urea removal, KT/V, URR, SRI, and normalized protein catabolic rate (nPCR) indices. The hemodialysis monitoring system preferably can obtain a dialysate sample equilibrated with the blood prior to the start of a hemodialysis treatment. In a further aspect of the hemodialysis monitoring system includes a device for conducting two-pool analysis for taking into account the constituent concentration differences in the extracellular and intracellular spaces in the hemodialysis patient during the hemodialysis treatment to determine the intercompartmental transfer coefficient K_I of a patient, which allows more precise adjustment of the hemodialysis prescription for the patient.

Claims

1. An apparatus for conducting equilibration of dialysate with a patient'"'"'s blood for a patient undergoing hemodialysis, comprising

connecting means for connecting to a dialysis machine for receiving a flow of dialysate therefrom and for connecting said flow to a dialyzer cartridge and directing a flow of dialysate from said dialysis machine through said dialyzer cartridge and back to said dialysis machine;

valve means actuatable between one position for stopping dialysate flow from said dialysis machine to said dialyzer cartridge and for directing said dialysate flow back to said dialysis machine, and for retaining a predetermined volume of dialysate in said dialyzer cartridge, and another position for allowing ultrafiltration to take place from the blood of the patient flowing through said dialyzer cartridge, with said returned pre-determined volume of dialysate remaining in said dialyzer cartridge ;

means for measuring the metabolite concentration in at least two samples of said retained pre-determined volume of dialysate and for continuing to sample said retained predetermined volume of dialysate until the difference in concentrations between two successive samples is less than a specified amount.

2. The apparatus in claim 1 wherein said means for measuring comprises a urea sensor.

3. The apparatus as in claim 1 further comprising flow measuring means for measuring the flow of dialysate from said dialysis machine when said valve means is in the another position for retaining said pre-determined volume.

4. The apparatus as in claim 1 wherein said valve means comprises a solenoid valve.

5. The apparatus as in claim 1 further comprising a flow meter for measuring the flow of dialysate diverted away from said dialyzer cartridge and to said dialysis machine by said valve means.

6. An apparatus for conducting equilibration of dialysate with a patient'"'"'s blood for a patient undergoing hemodialysis, comprising:

first dialysis connecting means for connecting to a dialysis machine for receiving a flow of dialysate therefrom;

first dialyzer connecting means for connecting said first dialysis connecting means to one end of a dialyzer cartridge and for directing said flow of dialysate from said dialysis machine to said dialyzer cartridge;

second dialyzer connecting means for connecting to another end of said dialyzer cartridge for directing said flow of dialysate from said dialyzer cartridge;

second dialysis connecting means for connecting said second dialyzer connecting means to said dialysis machine for directing said flow of dialysate from said dialyzer cartridge through said second dialyzer connecting means into said dialysis machine;

bypass means selectively actuatable between two positions, a first position in which the flow of dialysate is directed from said dialysis machine, through said first dialysis connecting means, through said first dialyzer connecting means, through said dialyzer cartridge, through said second dialyzer connecting means, and through said second dialysis connecting means for being returned to said dialysis machine, and a second position in which the flow of dialysate is shunted after passing through said first dialysis connecting means. before passing to said first dialyzer connecting means, for directing dialysate flow away from said dialyzer cartridge to said second dialysis connecting means for being returned directly to said dialysis machine without passing through said dialyzer cartridge; and

means for selectively sampling dialysate from said dialyzer cartridge when said bypass means is in said second position for measuring the concentration of metabolite in a selected sample of dialysate from the dialyzer cartridge.

7. The apparatus as in claim 6 further comprising flow measuring means for measuring the flow of dialysate from said dialysis machine when said bypass means is in said second position.

8. The apparatus as in claim 7 wherein said flow measuring means comprises a flow meter.

9. The apparatus as in claim 6 further comprising mounting means for mounting the apparatus on a dialysis machine.

10. The apparatus as in claim 6 wherein said bypass means comprises a solenoid valve.

11. The apparatus as in claim 6 wherein said means for selectively sampling comprises a urea sensor.