Method for measuring a characteristic in a sample fluid

• US 5,114,859 A
• Filed: 04/22/1991
• Issued: 05/19/1992
• Est. Priority Date: 07/21/1988
• Status: Expired due to Fees

• Current Assignee: Radiometer A/S (Danaher Corporation)
• Original Assignee: Radiometer A/S (Danaher Corporation)
• Inventors: Kagenow, Henrik
• Primary Examiner(s): Hart, Charles
• Application Number:
  US07/689,727
• Time in Patent Office: 393 Days
• Field of Search: 204/294, 204/416, 204/418, 204/419, 422/58, 422/63, 422/82.01, 422/82.05, 436/43, 436/50, 436/149, 436/151
• US Class Current: 436/50
• CPC Class Codes: B01L 2400/0478 pistons
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B01L 3/508 rigid containers not provided for above
• CPC Class Codes: G01N 35/00594 Quality control, including calibration or testing of components of the analyser
• CPC Class Codes: G01N 35/00693 Calibration
• CPC Class Codes: Y10T 436/115831 Condition or time responsive

Abstract

A method and apparatus for measuring a characteristic which is a function of the concentration of one or more chemical species in a sample fluid, examples being the concentration of sodium ion or potassium ion in blood, makes use of a discardable or disposable measuring device comprising one or more sensors, an example of a relevant type of sensor being a potentiometric electrode, one or more conditioning (e.g. calibration) fluid chambers and, optionally, a sample fluid chamber, the sensor(s) being movable relative to the chamber(s), or vice versa, so as permit conditioning of the sensor(s) in a conditioning fluid chamber and exposure of a sensing surface part of the sensor(s) to a sample fluid.

Claims

1. A method for measuring a characteristic which is a function of the concentration of one or more chemical species in a sample fluid, by using a measuring device comprising

a sensor having a sensing surface part, and

a chamber adapted to contain a conditioning fluid, the chamber being partly defined by a first wall part adapted to allow the sensor to pass through it and establish a seal around the sensor when the sensor traverses the first wall part, the sensor and the chamber being movable relative to each other so as to transfer the sensing surface part of the sensor through the first wall part from a position where the sensing surface part of the sensor is inside the chamber to a position where it is outside the chamber,

the method comprising

exposing the sensing surface part of the sensor to a conditioning fluid in the chamber,

moving the sensor and the chamber relative to each other so as to transfer the sensing surface part of the sensor through the first wall part and position it outside the chamber,

exposing the sensing surface part of the sensor to a sample fluid,

deriving the characteristic on the basis of a response generated by the sensor when the sensing surface part of the sensor is exposed to the sample fluid, and, optionally, a response generated by the sensor when the sensing surface part of the sensor is exposed to the conditioning fluid, and

discarding the measuring device after one measurement of the characteristic.

5. A method according to claim 1, wherein the conditioning fluid in the chamber is provided from a store of conditioning fluid within the measuring device, said store being adapted for release of conditioning fluid into the conditioning fluid chamber.

8. A method according to claim 5, wherein the conditioning fluid is stored in a closed and rupturable pack, the packaging material of the pack being substantially gas-tight when the fluid is a gas, and liquid, and gas.tight when the fluid is a liquid, the release of the conditioning fluid from the pack preferably being obtained by application of pressure to, optionally in combination with perforation of, the pack.

9. A method according to any of the preceding claim 1, wherein the measuring device comprises a sample fluid chamber adapted to contain the sample fluid containing the chemical species, the sample fluid chamber having inlet means for introducing the sample fluid into the sample fluid chamber and being partly defined by the first wall part, the sensor and the sample fluid chamber being movable relative to each other so as to transfer the sensing surface part of the sensor through the first wall part from a position where the sensing surface part of the sensor is inside the conditioning fluid chamber to a position where it is inside the sample fluid chamber, or vice versa.

10. A method according to claim 1, wherein the measuring device comprises a sample fluid chamber adapted to contain the sample fluid containing the chemical species, the sample fluid chamber having inlet means for introducing the sample fluid into the sample fluid chamber and being partly defined by the first wall part, the sensor and the sample fluid chamber being movable relative to each other so as to transfer the sensing surface part of the sensor through the first wall part from a position where the sensing surface part of the sensor is inside the conditioning fluid chamber to a position where it is inside the sample fluid chamber, or vice versa, and the discardment of the measuring device taking place without any prior discharge of sample fluid or conditioning fluid from the measuring device.

11. A method according to claim 9, wherein the sample fluid chamber of the measuring device is partly defined by a second wall Part adapted to allow the sensor to pass through it and establish a seal around the sensor, the sensor traversing the second wall part before said use of the measuring device.

12. A method according to claim 1, wherein the first wall part of the measuring device is ruptured by the sensor following movement of the sensor and the first wall part relative to each other.

13. A method according to claim 12, wherein the first wall part comprises a weakened area, the rupturing of the first wall part by the sensor occurring within said area.

14. A method according to any of claim 1, wherein the sensor of the measuring device traverses the first wall part before said use of the measuring device.

15. A method according to claim 1, wherein the conditioning fluid chamber of the measuring device is partly defined by a third wall part adapted to allow the sensor to pass through it and establish a seal around the sensor when the sensor traverses the third wall part, the sensor and the conditioning fluid chamber being movable relative to each other so as to transfer the sensing surface part of the sensor through the third wall part from a position where the sensing surface part of the sensor is outside the conditioning fluid chamber to a position where it is inside the conditioning fluid chamber.

16. A method according to claim 15, wherein the third wall part of the measuring device is ruptured by the sensor following movement of the sensor and the conditioning fluid chamber relative to each other.

17. A method according to claim 16, wherein the third wall part comprises a weakened area, the rupturing of the third wall part by the sensor occurring within said area.

18. A method according to claim 15, wherein the sensor of the measuring device traverses the third wall part before said use of the measuring device.

19. A method according to claim 1, wherein the sensor is a sensor generating a response in the form of an electrical or optical signal.

23. A method according to claim 1 wherein the sample fluid is whole blood.

2. A method for measuring a characteristic which is a function of the concentration of one or more chemical species in a sample fluid, by using a measuring device comprising

a sensor having a sensing surface part, and

a chamber adapted to contain a conditioning fluid, the chamber being partly defined by a first wall part adapted to allow the sensor to pass through it and establish a seal around the sensor when the sensor traverses the first wall part, the sensor and the chamber being movable relative to each other so as to transfer the sensing surface part of the sensor through the first wall part from a position where the sensing surface part of the sensor is outside the chamber to a position where it is inside the chamber,

the method comprising

exposing the sensing surface part of the sensor to a sample fluid,

moving the sensor and the chamber relative to each other so as to transfer the sensing surface part of the sensor through the first wall part and position it inside the chamber,

exposing the sensing surface part of the sensor to a conditioning fluid in the chamber

deriving the characteristic on the basis of a response generated by the sensor when the sensing surface part of the sensor is exposed to the sample fluid, and a response generated by the sensor when the sensing surface part of the sensor is exposed to the conditioning fluid, and

discarding the measuring device after one measurement of the characteristic.

3. A method for measuring a characteristic which is a function of the concentration of one or more chemical species in a sample fluid, by using a measuring device comprising

a sensor having a sensing surface part, and

a chamber adapted to contain a conditioning fluid, the chamber being partly defined by a first wall part adapted to allow the sensor to pass through it and establish a seal around the sensor when the sensor traverses the first wall part, the sensor and the chamber being movable relative to each other so as to transfer the sensing surface part of the sensor through the first wall part from a position where the sensing surface part of the sensor is inside the chamber to a position where it is outside the chamber,

the method comprising

exposing the sensing surface part of the sensor to a conditioning fluid in the chamber,

moving the sensor and the chamber relative to each other so as to transfer the sensing surface part of the sensor through the first wall part and position it outside the chamber,

exposing the sensing surface part of the sensor to a sample fluid,

deriving the characteristic on the basis of a response generated by the sensor when the sensing surface part of the sensor is exposed to the sample fluid, and, optionally, a response generated by the sensor when the sensing surface part of the sensor is exposed to the conditioning fluid, and

discarding the measuring device after more than one measurement of the characteristic, the discardment taking place before the conditioning fluid is no longer capable of properly exerting its conditioning function.

4. A method for measuring a characteristic which is a function of the concentration of one or more chemical species in a sample fluid, by using a measuring device comprising

a sensor having a sensing surface part, and

a chamber adapted to contain a conditioning fluid, the chamber being partly defined by a first wall part adapted to allow the sensor to pass through it and establish a seal around the sensor when the sensor traverses the first wall part, the sensor and the chamber being movable relative to each other so as to transfer the sensing surface part of the sensor through the first wall part from a position where the sensing surface part of the sensor is outside the chamber to a position where it is inside the chamber.

the method comprising

exposing the sensing surface part of the sensor to a sample fluid,

moving the sensor and the chamber relative to each other so as to transfer the sensing surface part of the sensor through the first wall part and position it inside the chamber,

exposing the sensing surface part of the sensor to a conditioning fluid in the chamber

deriving the characteristic on the basis of a response generated by the sensor when the sensing surface part of the sensor is exposed to the sample fluid, and a response generated by the sensor when the sensing surface part of the sensor is exposed to the conditioning fluid, and

discarding the measuring device after more than one measurement of the characteristic, the discardment taking place before the conditioning fluid is no longer capable of properly exerting its conditioning function.

6. A method for measuring a characteristic which is a function of the concentration of one or more chemical species in a sample fluid, by using a measuring device comprising

a sensor having a sensing surface part,

a chamber adapted to contain a portion of conditioning fluid, the chamber being partly defined by a first wall part adapted to allow the sensor to pass through it and establish a seal around the sensor when the sensor traverses the first wall part, the sensor and the chamber being movable relative to each other so as to transfer the sensing surface part of the sensor through the first wall part from a position where the sensing surface part of the sensor is inside the chamber to a position where it is outside the chamber, and

a store of conditioning fluid adapted for release of conditioning fluid into the conditioning fluid chamber,

the method comprising

exposing the sensing surface part of the sensor to a conditioning fluid in the chamber,

moving the sensor and the chamber relative to each other so as to transfer the sensing surface part of the sensor through the first wall part and position it outside the chamber,

exposing the sensing surface part of the sensor to a sample fluid,

deriving the characteristic on the basis of a response generated by the sensor when the sensing surface part of the sensor is exposed to the sample fluid, and, optionally, a response generated by the sensor when the sensing surface part of the sensor is exposed to the conditioning fluid,

replacing the conditioning fluid in the chamber with a fresh portion of conditioning fluid from said store after each measurement of the characteristic, and

discarding the measuring device before or when the store of conditioning fluid has been consumed.

7. A method for measuring a characteristic which is a function of the concentration of one or more chemical species in a sample fluid, by using a measuring device comprising

a sensor having a sensing surface part,

a chamber adapted to contain a portion of conditioning fluid, the chamber being partly defined by a first wall part adapted to allow the sensor to pass through it and establish a seal around the sensor when the sensor traverses the first wall part, the sensor and the chamber being movable relative to each other so as to transfer the sensing surface part of the sensor through the first wall part from a position where the sensing surface part of the sensor is outside the chamber to a position where it is inside the chamber, and

store of conditioning fluid adapted for release of conditioning fluid into the conditioning fluid chamber,

the method comprising

exposing the sensing surface part of the sensor to a sample fluid,

moving the sensor and the chamber relative to each other so as to transfer the sensing surface part of the sensor through the first wall part and position it inside the chamber,

exposing the sensing surface part of the sensor to a conditioning fluid in the chamber

deriving the characteristic on the basis of a response generated by the sensor when the sensing surface part of the sensor is exposed to the sample fluid, and a second response generated by the sensor when the sensing surface part of the sensor is exposed to the conditioning fluid,

replacing the conditioning fluid in the chamber with a fresh portion of conditioning fluid from said store after each measurement of the characteristic, and

discarding the measuring device before or when the store of conditioning fluid has been consumed.

20. A method for measuring a characteristic which is a function of the concentration of one or more chemical species in a sample fluid, by using a measuring device comprising

a sensor having a sensing surface part, the sensing surface part requiring no exposure to a conditioning fluid, and

a sample fluid chamber adapted to contain the sample fluid containing the chemical species, the sample fluid chamber having inlet means for introducing the sample fluid into the sample fluid chamber and being partly defined by a wall part adapted to allow the sensor to pass through it and establish a seal around the sensor when the sensor traverses the wall part, the sensor and the sample fluid chamber being movable relative to each other so as to transfer the sensing surface part of the sensor through the wall part from a position where the sensing surface part of the sensor is outside the sample fluid chamber to a position where it is inside the sample fluid chamber,

the method comprising

introducing a sample fluid into the sample fluid chamber,

moving the sensor and the sample fluid chamber relative to each other so as to transfer the sensing surface part of the sensor through the wall part, thereby positioning it inside the chamber and exposing it to the sample fluid,

deriving the characteristic on the basis of a response generated by the sensor when the sensing surface part of the sensor is exposed to the sample fluid, and

discarding the measuring device after one measurement of the characteristic.

21. A method according to claim 20, wherein the wall part of the sample fluid chamber is ruptured by the sensor following movement of the sensor and the sample fluid chamber relative to each other.

22. A method according to claim 21, wherein the wall part comprises a weakened area, the rupturing of the wall part by the sensor occurring within said area.

24. An analysis system for measuring a characteristic which is a function of the concentration of one or more chemical species in a sample fluid, comprising

a discardable measuring device which comprises

a sensor from whose response the characteristic can be derived, and comprising a sensing surface part and sensor response output means, and

a sample fluid chamber adapted to contain a sample fluid containing the chemical species, the sample fluid chamber having inlet means for introducing the sample fluid into the sample fluid chamber, and being partly defined by a wall part, the sensor and the sample fluid chamber being movable relative to each other so as to transfer the sensing surface part of the sensor through the wall part from a position where the sensing surface part of the sensor is outside the sample fluid chamber to a position where it is inside the sample fluid chamber, or vice versa, and

an analyzer adapted to removably accommodate the measuring device and provided with means for bringing about movement of the sensor and the sample fluid chamber relative to each other when the measuring device is accommodated in the analyzer, sensor response transmission means, and means for registering the response generated by the sensor, said sensor response transmission means facilitating communication between the sensor response output means of the sensor and the sensor response registering means of the analyzer.

25. A system according to claim 24, wherein the analyzer comprises means for processing the registered response data so as to derive the desired characteristic therefrom.

26. A system according to claim 24, wherein the measuring device comprises

a chamber adapted to contain a portion of conditioning fluid, the chamber being partly defined by a wall part adapted to allow the sensor to pass through it and establish a seal around the sensor when the sensor traverses the wall part, the sensor and the chamber being movable relative to each other so as to transfer the sensing surface part of the sensor through the wall part from a position where the sensing surface part of the sensor is outside the chamber to a position where it is inside the chamber, or vice versa, and

a store of conditioning fluid adapted for release of conditioning fluid into the conditioning fluid chamber, and

the analyzer comprises means for bringing about the release of the conditioning fluid into the conditioning fluid chamber.

27. A discardable measuring device for measuring a characteristic which is a function of the concentration of one or more chemical species in a sample fluid, comprising

a sensor from whose response the characteristic can be derived, and comprising a sensing surface part, and

a chamber adapted to contain a conditioning fluid, the chamber having a wall part which initially constitutes an intact boundary between the inside and the outside of the chamber, the wall part being rupturable by the sensor and adapted to allow the sensor to pass through it and establish a seal around the sensor when the sensor traverses the wall part, the sensor and the chamber being movable relative to each other so as to transfer the sensing surface part of the sensor through the wall part from a position where the sensing surface part of the sensor is inside the chamber to a position in which it is outside the chamber.

28. A discardable measuring device according to claim 27, wherein the wall part is ruptured by the sensor following movement of the sensor and the chamber relative to each other.

29. A discardable measuring device according to claim 28, wherein the wall part comprises a weakened area, the rupturing of the wall part by the sensor occurring within said area.

30. A discardable measuring device according to claim 27, comprising a sample fluid chamber adapted to contain the sample fluid containing the chemical species, the sample fluid chamber having inlet means for introducing the sample fluid into the sample fluid chamber and being partly defined by the wall part, the sensor and the sample fluid chamber being movable relative to each other so as to transfer the sensing surface part of the sensor through the wall part from a position where the sensing surface part of the sensor is inside the conditioning fluid chamber to a position where it is inside the sample fluid chamber, or vice versa.

31. A discardable measuring device according to claim 30, wherein the sample inlet means comprise a fitting adapted for attachment of a syringe needle or a catheter.

32. A discardable measuring device for measuring a characteristic which is a function of the concentration of one or more chemical species in a sample fluid, comprising

a sensor from whose response the characteristic can be derived, and comprising a sensing surface part,

a chamber adapted to contain a portion of conditioning fluid, the chamber being partly defined by a wall part adapted to allow the sensor to pass through it and establish a seal around the sensor when the sensor traverses the wall part, the sensor and the chamber being movable relative to each other so as to transfer the sensing surface part of the sensor through the wall part from a position where the sensing surface part of the sensor is inside the chamber to a position where it is outside the chamber, or vice versa, and

a store of conditioning fluid in a closed and rupturable pack, the packaging material of the pack being substantially gas-tight when the fluid is a gas and liquid, and gas.tight when the fluid is a liquid, the pack being arranged so that the conditioning fluid will be discharged into the conditioning fluid chamber upon rupture of the pack.

33. A discardable measuring device according to claim 32, wherein the wall part is ruptured by the sensor following movement of the sensor and the chamber relative to each other.

34. A discardable measuring device according to claim 33, wherein the wall part comprises a weakened area, the rupturing of the wall part by the sensor occurring within said area.

35. A discardable measuring device according to claim 32, comprising

a sample fluid chamber adapted to contain the sample fluid containing the chemical species, the sample fluid chamber having inlet means for introducing the sample fluid into the sample fluid chamber and being partly defined by the wall part, the sensor and the sample fluid chamber being movable relative to each other so as to transfer the sensing surface part of the sensor through the wall part from a position where the sensing surface part of the sensor is inside the conditioning fluid chamber to a position where it is inside the sample fluid chamber, or vice versa.

36. A discardable measuring device according to claim 32, wherein the sample inlet means comprise a fitting adapted for attachment of a syringe needle or a catheter.

38. A discardable measuring device according to claim 33, wherein the wall part is ruptured by the sensor following movement of the sensor and the sample fluid chamber relative to each other.

39. A discardable measuring device according to claim 38, wherein the wall part comprises a weakened area, the rupturing of the wall part by the sensor occurring within said area.

37. A discardable measuring device for measuring a characteristic which is a function of one or more chemical species in a sample fluid, comprising

a sensor from whose response the characteristic can be derived, and comprising a sensing surface part, and

sample fluid chamber adapted to contain a sample fluid containing the chemical species, the sample fluid chamber having inlet means for introducing the sample fluid into the sample fluid chamber and being partly defined by a wall part, the sensor and the sample fluid chamber being movable relative to each other so as to transfer the sensing surface part of the sensor through the wall part from a position where the sensing surface part of the sensor is outside the sample fluid chamber to a position where it is inside the sample fluid chamber,

the sensing surface part of the sensor initially being positioned outside the sample fluid chamber in a dry condition.

40. A discardable measuring device according to claim 37, wherein the sample inlet means comprise a fitting adapted for attachment of a syringe needle or a catheter.

41. A discardable measuring device for measuring the individual concentrations of a plurality of chemical species in a sample fluid, comprising

a plurality of sensors, of types requiring conditioning and/or of types not requiring conditioning, each of which is responsive to an individual chemical species and comprises a sensing surface part adapted to be exposed to the sample fluid,

a sample fluid chamber adapted to contain the sample fluid, the sample fluid chamber having inlet means for introducing the sample fluid into the sample fluid chamber and being partly defined by a first wall part, said first wall part being adapted to allow each sensor to pass through it and establish a seal around each sensor when said sensor traverses the first wall part, each sensor being movable relative to the sample fluid chamber so as to transfer the sensing surface part of said sensor through the first wall part from a position where the sensing surface part of said sensor is outside the sample fluid chamber to a position where it is inside said sample fluid chamber, and

in those cases where the measuring device comprises one or more sensors of types requiring conditioning, further comprising

one or more chambers, each of which is adapted to contain a conditioning fluid and is partly defined by said first wall part, the sensing surface part of each sensor being inside a conditioning fluid chamber when it is outside the sample fluid chamber,

one or more stores of individual conditioning fluids, the store or each of the stores being stored in a closed and rupturable pack, each pack being positioned in a compartment from which there is direct access to a conditioning fluid chamber, one or more pressure-applying means, via which pressure can be exerted on one such rupturable pack so as to rupture said pack and release its store of conditioning fluid into a conditioning fluid chamber, each such pressure-applying means partly delimiting in a fluid-tight manner one such compartment.

42. A discardable measuring device according to claim 41, wherein one or more pressure-applying means comprise(s) a flexible membrane.

43. A discardable measuring device according to claim 41, wherein the sensors comprise sensors selected from body fluid component sensors, preferably glucose sensors, potassium sensors, and sodium sensors.

44. A discardable measuring device according to claim 41, wherein the sample inlet means comprise a fitting adapted for attachment of a syringe needle or a catheter.