Ion selective/enzymatic electrode medical analyzer device and method of use

• US 4,935,106 A
• Filed: 11/15/1985
• Issued: 06/19/1990
• Est. Priority Date: 11/15/1985
• Status: Expired due to Fees

• Current Assignee: Smithkline Diagnostics, Inc. (GSK plc)
• Original Assignee: Smithkline Diagnostics, Inc. (GSK plc)
• Inventors: Daffern, George M., Dickinson, David G., Fetty, James G., Hsei, Paul K., Liston, Max D.
• Primary Examiner(s): Kaplan, G. L.
• Application Number:
  US06/798,791
• Time in Patent Office: 1,677 Days
• Field of Search: 204/400, 204/401, 204/402, 204/403, 204/406, 204/407, 204/409, 204/411, 204/412, 204/416, 204/1 T, 204/1 E, 204/1 A, 73/1 R, 364/497
• US Class Current: 205/778
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001

Abstract

A modular multi-channel automated medical analyzer device is disclosed, characterized by use of an ion selective electrode and/or enzymatic electrode/wash cell system which permits rapid analysis of various substances of interest contained within undiluted body fluids such as whole blood, serum and/or plasma. The ion selective electrode and/or the enzymatic electrode are disposed upon a probe which automatically axially reciprocates downwardly in a simple manipulative motion between an open-ended reference wash cell and a sample cup bearing the body fluid specimen to be analyzed. The wash cell includes an inlet port and one or more outlet ports through which is circulated an aqueous solution bearing a known concentration of the substance to be measured to provide a reference calibration medium as well as a probe washing medium. The probe is lowered directly into the sample cup to physically contact the specimen to be measured and, after analysis, is lifted upwardly into the wash cell wherein any attendant portion of the specimen remaining on the probe is stripped off by suction and the aqueous solution flow through the wash cell is initiated to thoroughly wash the probe and establish a new calibration medium for subsequent specimen analysis. The wash cell/probe assembly is specifically designed to prevent any leakage or drooling of the aqueous solution from the wash cell into the sample cup throughout manipulation of the probe. Operation of each of the modules of the analyzer is facilitated through common processing and control electronics and test measurements are accomplished initially on a dual point calibration procedure and subsequently on a single point calibration procedure.

Claims

1. An analyzer device for measuring the concentration of a desired substance contained within a body fluid sample comprising:

a probe bearing an electrode for generating an electric signal in response to the detection of the desired substance;

a sample cup formed to receive a static quantity of body fluid sample therein;

a vessel formed to receive said probe and store a quantity of solution bearing a known concentration of the desired substance to be measured, said vessel being spatially separated at a position vertically above said sample cup and including an opening at its lower distal end;

means for axially reciprocating said probe through said opening between said vessel and said sample cup to generate an electric signal from said electrode in both the quantity of solution and body fluid sample;

means for processing said electrical signals to derive a resultant concentration value of the desired substance within the body fluid sample;

means for displaying said resultant concentration level; and

means cooperating with said vessel for preventing the passage of solution stored within said vessel through said opening in said vessel, wherein said preventing means comprises means for forming an inverted fluid meniscus which extends across said opening.

2. The device of claim 1 further comprising means for periodically circulating a quantity of said solution through said vessel without passage of said solution through said opening in said vessel.

3. The device of claim 2 wherein said solution circulating means comprises an outlet port formed in said vessel positioned adjacent said opening;

an inlet port formed in said vessel positioned at an elevation above said outlet port;

means for supplying said inlet port with a quantity of said solution and means for simultaneously removing said quantity of said solution from said outlet port.

4. The device of claim 3 further comprising a second outlet port formed in said vessel at an elevation above said inlet port.

5. The device of claim 2 wherein said probe is formed to possess a thermal mass substantially greater than the thermal mass of the body fluid received within said sample cup to equalize the temperature of said body fluid to the probe temperature upon immersion of the probe into the body fluid.

6. The device of claim 5 wherein the electrode on said probe comprises an ion selective electrode.

7. The device of claim 5 wherein the electrode on said probe comprises an enzymatic electrode.

8. The device of claim 5 wherein the electrode on said probe comprises a pair of electrodes.

9. A method of measuring the concentration of a substance of interest contained within a body fluid sample comprising the steps of:

calibrating an electrode in a vessel having a lower open end and containing a column of a solution bearing a known concentration of a substance of interest desired to be measured;

maintaining an inverted fluid meniscus adjacent said lower open end of said vessel to prevent the passage of said column of solution through said lower open end of said vessel;

axially transporting said electrode through the open end of said vessel into a sample cup having a quantity of body fluid contained therein;

generating an electric signal from said electrode in response to the sensing of the substance of interest within said quantity of body fluid;

processing said electric signal to derive a concentration value of the substance of interest within said quantity of body fluid; and

displaying said concentration value.

10. The method of claim 9 comprising the further step of drying said electrode to remove any portion of said column of solution from said electrode prior to said electrode contacting said body fluid contained in said sample sup.

11. The method of claim 10 comprising the further step of axially transporting said electrode from said sample cup back to said vessel subsequent to said generating step.

12. The method of claim 11 comprising the further step of drying said electrode prior to said electrode being transported back into said vessel.

13. The method of claim 12 wherein said calibration step comprises the steps of:

generating an electric signal from said electrode in response to the sensing of the substance of interest by the column of solution contained within said vessel;

processing said electric signal to derive a calibration slope value for said electrode; and

storing said calibration slope value for use in the processing of said electric signal generated by said electrode in said body fluid.

14. A method of manipulating an electrode bearing probe between a vessel having an open lower end and a sample sup bearing a body fluid specimen physically separated and disposed vertically below said vessel comprising the steps of:

disposing an electrode bearing probe within a vessel defining a fluid chamber having an open lower end;

supplying a quantity of fluid to fill said fluid chamber while preventing the passage of fluid through said open end of said chamber by maintaining an inverted fluid meniscus adjacent said open end of said chamber;

axially reciprocating said probe through said open end of said vessel and into the sample cup to immerse said electrode probe in a body fluid specimen contained in the sample cup while drawing a vacuum adjacent said open end of said chamber to remove any portion of said fluid from said probe; and

axially reciprocating said probe from the sample cup into said vessel while drawing a vacuum adjacent said open end of said chamber to remove any portion of the body fluid sample remaining on said probe from said probe.

15. The method of claim 14 comprising the further step of vertically bobbing the electrode bearing probe within the body fluid sample to remove any air bubbles accumulating on said probe with the body fluid sample.

16. The method of claim 15 comprising the further step of vertically bobbing the electrode bearing probe within said fluid chamber to wash said probe within said vessel.

17. An analyzer device fox measuring the concentration of a desired substance contained within a body fluid sample comprising:

a probe;

sensor means carried by said probe for generating a signal in response to the detection of the desired substance;

a sample cup formed to receive a quantity of body fluid sample therein;

a vessel disposed vertically above said sample cup, said vessel having a lower open end and formed to receive said probe and store a quantity of fluid bearing a known concentration of the desired substance to be measured;

means disposed within said vessel for forming an inverted fluid meniscus adjacent said lower open end of said vessel to prevent any passage of said fluid through said lower open end;

means for axially reciprocating said probe between said vessel and said sample cup to generate a signal from said sensor means in both the quantity of fluid and body fluid sample;

means for processing said signals to derive a resultant concentration value of the desired substance within the body fluid sample; and

means for displaying said resultant concentration level.

18. The device of claim 17 wherein said sensor means comprises an ion selective electrode.

19. The device of claim 17 wherein said sensor means comprises a pair of ion selective electrodes.

20. The device of claim 17 wherein said sensor means comprises an enzymatic electrode.

21. The device of claim 17 wherein said vessel is formed to permit the washing and calibration of said sensor within said quantity of fluid.

22. A medical analyzer device for measuring the concentration of a desired substance within a body fluid sample comprising:

a housing;

at least one test solution module insertable into said housing;

a probe carried by said test station responsive to the presence of a desired substance within a body fluid sample;

a vessel carried by said test station module formed to receive said probe and store a quantity of solution therein and including an opening at its lower end;

a sample cup positioned upon said test station module physically separated from said vessel and disposed at an elevation below said vessel and coaxial with said probe, said sample cup formed to receive a body fluid sample therein;

means carried by said test station module for periodically circulating a wash and calibration solution through said vessel;

means for forming an inverted fluid meniscus adjacent the opening of said vessel to prevent the passage of solution contained within said vessel through said opening;

means mounted to said test station module for axially reciprocating said probe between said vessel and said sample cup;

means mounted to said housing for controlling the operation of said circulating and reciprocation means and processing information received from said probe; and

display means positioned on said housing for displaying the processed information representing the concentration of the desired substance contained within the body fluid sample.

23. The device of claim 22 wherein said circulating means comprises:

a first reservoir for storing a quantity of said wash and calibration solution;

a pump for supplying a quantity of said solution from said first reservoir and into said vessel and removing said solution from said vessel at a flow rate equal to the flow rate of said solution being supplied to said vessel; and

a second reservoir for receiving said solution being removed from said vessel.

24. The device of claim 23 further comprising means positioned between said pump and said second reservoir for removing air from said solution prior to delivery of said solution into said second reservoir.

25. The device of claim 24 wherein said axial reciprocation means comprises:

a carriage mounted to said probe and adapted for reciprocal movement within said test station module; and

a motor cooperating with said carriage to reciprocate said carriage in a direction parallel to the axis of said probe.

26. The device of claim 25 further comprising sensor means cooperating with said carriage for confirming the length of reciprocal travel of said carriage

27. The device of claim 25 further comprising means formed on one end of said probe for mounting said probe to said carriage, said means providing both a mechanical and electrical interface between said probe and said carriage.

28. The device of claim 25 further comprising means mounted to said test station module for releasably mounting said sample cup to said test station module.

29. The device of claim 28 wherein said sample cup mounting means additionally includes means for coaxially registering said sample cup with said probe.

30. The device of claim 29 further comprising means formed on said sample cup mounting means for providing a detent mechanism for ensuring proper positioning of said sample cup upon said sample cup mounting means.

31. The device of claim 30 wherein said vessel and said sample cup mounting means are releasably mounted to said test station module.

32. The device of claim 24 wherein said pump comprises a multi-channel peristaltic pump.

33. An analyzer device for measuring the concentration of a substance of interest contained within a body fluid sample comprising:

a probe bearing an electrode for generating an electric signal in response to the detection of the substance of interest;

a sample cup formed to receive a body fluid sample therein;

a vessel formed to receive said probe and store a quantity of solution bearing a known concentration of the substance of interest to be measured, said vessel having an opening at its lower end;

means for axially reciprocating said probe between said vessel and said sample cup to generate an electric signal from said electrode in both said quantity of solution and said body fluid sample;

means for processing said electrical signals to derive a resultant concentration value of the substance of interest within said body fluid sample, said probe being formed to possess a thermal mass and thermal conductivity sufficient to rapidly adjust the temperature of the body fluid sample to the temperature of said quantity of solution upon entry of said probe into said sample cup; and

means for preventing the passage of solution through the opening of said vessel, wherein said preventing means comprises means for forming an inverted fluid meniscus which extends across said opening.

34. The device of claim 33 herein said probe is formed of stainless steel material.

35. A method of measuring the concentration of a substance of interest contained within a body fluid sample comprising the steps of:

calibrating an electrode in a vessel having a lower open end and containing a column of a solution bearing a known concentration of a substance of interest desired to be measured;

maintaining an inverted fluid meniscus adjacent said lower open end of said vessel to prevent the passage of said column of solution through said lower upper end of said vessel;

axially transporting said electrode from a first position in said vessel to a second position outside of said vessel to dispose said electrode in a body fluid sample;

rapidly adjusting the temperature of said body fluid sample to the temperature of said solution bearing a known concentration of the substance to be measured by thermal interaction of said electrode and said body fluid sample;

generating an electric signal from said electrode in response to the sensing of the substance of interest within said body fluid sample; and

processing said electric signal to derive a concentration value of the substance of interest within said body fluid sample.

36. The method of claim 35 comprising the further step of axially transporting said electrode from said body fluid sample back to said vessel.

37. The method of claim 36 comprising the further step of washing said electrode in said vessel.

38. The method of claim 37 wherein said washing step comprises circulating a quantity of said solution bearing a known concentration of a substance of interest desired to be measured through said vessel.

39. The method of claim 38 wherein between said calibrating step and said axially transporting step said method comprises the further step of drying said electrode.

40. The method of claim 39 wherein prior to said washing step said method comprises the further step of removing the major portion of any body fluid sample remaining on said electrode.