Apparatus and method for determining serum concentrates of metabolites by monitoring dialysate fluid

• US 4,244,787 A
• Filed: 06/11/1979
• Issued: 01/13/1981
• Est. Priority Date: 06/11/1979
• Status: Expired due to Term

• Current Assignee: United States of America As Represented By The Secretary of The Department of Health Education and Welfare
• Original Assignee: United States of America As Represented By The Secretary of The Department of Health Education and Welfare
• Inventors: Klein, Elias, Wathen, Ronald L.
• Primary Examiner(s): Prescott, Arthur C.
• Application Number:
  US06/047,786
• Time in Patent Office: 582 Days
• Field of Search: 204/180 P, 204/1 T, 204/195 B, 204/195 M, 204/195 P, 195/103.5 C, 23/230 B, 424/12
• US Class Current: 205/778
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1609 after use, i.e. downstream of dialyser
• 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 2202/0498 Urea
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate

Abstract

An apparatus and method are disclosed for monitoring, analyzing and quantitating in real time the concentrations of metabolites in serum by analyzing the dialysate solutions which are being equilibrated with the blood via a hemodialyzer. Thus, access to certain metabolically important species is provided without the necessity of blood sampling. The apparatus includes at least one ion-selective electrode coupled with the dialysate effluent stream, and the electrode EMF is converted to dialysate concentrations based on precalibration. The dialysate concentrations, in turn, are related to serum levels by factors governing mass transfer through the dialyzer.

Claims

1. The method of determining the level of a predetermined metabolically important species in serum, without withdrawing blood or entering a sensor into the bloodstream, comprising the steps of:

diverting at least a portion of a dialysate effluent stream, obtained from equilibration with blood through a hemodialyzer, through a sampling apparatus, including an ion-specific electrode sensitive to a desired species;

producing an electrode EMF proportional to the concentration of the sensed species; and

converting the EMF to data indicating the dialysate concentrations of the species and determining the serum levels of the species from such data.

2. The method as in claim 1, wherein:

serum urea is monitored by diverting the dialysate effluent through an immobilized ureas column, wherein the urea is hydrolized to ammonia, and the concentration of ammonium-ion is sensed by the electrode.

3. The method as in claim 2, wherein:

an equal volume of buffer solution is added to the dialysate effluent prior to sampling, thereof.

4. The method as in claim 1, wherein:

serum phosphate is monitored by maintaining a partial pressure of oxygen in a reservoir of the dialysate effluent and a phosphate ion sensitive electrode is used to analyze the dialysate effluent.

5. The method as in claim 4, wherein:

buffer is added to the dialysate effluent in the ratio of fifty parts buffer to one part dialysate effluent.

6. An apparatus for monitoring a blood serum metabolite by analyzing dialysate effluent equilibrated with blood via a hemodialyzer, comprising:

diverting means for diverting at least a portion of the dialysate effluent into a sampling apparatus;

sampling means in the sampling apparatus for selectively sampling a predetermined metabolite species present in the dialysate effluent, said sampling means including an ion-specific electrode for producing an EMF proportionate to the concentration of the species in the dialysate effluent; and

means for converting the EMF to dialysate concentrations, which are, in turn, used to determine serum concentration of the species.

7. An apparatus as in claim 6, wherein:

the sampling apparatus continuously samples the species in the dialysate effluent; and

a recording device is connected to the means for converting the electrode EMF to record the species concentrations during hemodialysis.

8. An apparatus as in claim 6, further comprising:

means to add a buffer solution to the dialysate effluent prior to sampling thereof, said means including a source of buffer solution; and

means to pump an aliquot of said dialysate effluent and a selected quantity of buffer to said sampling means.

9. An apparatus as in claim 6, wherein:

a plurality of calibrated solutions are connected to be added to the dialysate effluent prior to sampling thereof, to detect any drifts in the electronics, or other aberrations, and to provide a check on the stability and respone of the electrode with time.

10. An apparatus as in claim 6, wherein:

the predetermined metabolite species is urea;

the sampling apparatus includes an immobolized ureas column, through which the dialysate effluent is passed, during which the urea in the dialysate effluent is hydrolized to ammonia; and

the electrode is a selective ammonium-ion sensitive electrode.

12. Apparatus as in claim 8, wherein said means to pump comprises a peristaltic pump, said means to add a buffer solution to the dialysate effluent comprising a line which joins with said diverting means downstream of said peristaltic pump;

said sampling means including an immobilized ureas column through which dialysate effluent is adapted to be passed for hydrolysis of urea to ammonia; and

said ion-specific electrode is an ammonium-ion sensitive electrode with an internal reference probe.

11. An apparatus for determining the level of a predetermined metabolically important species in serum, without withdrawing blood or entering a sensor into the bloodstream, comprising:

diverting means for diverting at least a portion of a dialysate effluent stream, obtained from equilibration with blood through a hemodialyzer, through a sampling apparatus, including an ion-specific electrode sensitive to a desired species;

means to produce an electrode EMF proportional to the concentration of the sensed species; and

means to convert the EMF to data indicating the dialysate concentrations of the species and to determine the serum levels of the species from such data.