Fluid dose, flow and coagulation sensor for medical instrument

• US 5,789,664 A
• Filed: 03/29/1996
• Issued: 08/04/1998
• Est. Priority Date: 08/31/1993
• Status: Expired due to Term

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Boehringer Mannheim Corporation
• Inventors: Murphy, William J., Storvick, David E., Neel, Gary T., Young, Morris J., Parker, James R., Kennedy, Daniel L., Collins, Rick L., Thomeczek, Charles L. Jr., Lennert, George R.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US08/623,872
• Time in Patent Office: 858 Days
• Field of Search: 128/630, 128/632, 128/664-6, 128/637-8, 128/634, 356/39-41, 73/53.01, 73/64.43, 422/73, 436/69
• US Class Current: 73/53.01
• CPC Class Codes: G01N 11/06 by timing the outflow of a known quantity
• CPC Class Codes: G01N 21/0303 Optical path conditioning in cuvettes, e.g. windows; adapted optical elements or systems; path modifying or adjustment G01N21/031 - G01N21/15 take precedence
• CPC Class Codes: G01N 21/0332 with temperature control control of temperature G05D23/00; cryostats F17C3/08
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• CPC Class Codes: G01N 35/00594 Quality control, including calibration or testing of components of the analyser
• CPC Class Codes: G01N 35/00693 Calibration

Abstract

An instrument and a method for determining a characteristic of a biological fluid or control comprise providing a radiation-reflective surface, a source for irradiating the surface, a detector for detecting radiation reflected from the surface, and a cuvette for holding a sample of the biological fluid or control. The cuvette has two opposed walls substantially transparent to the source radiation and reflected radiation. The source and detector are disposed adjacent a first one of the two opposed walls and the radiation reflective surface is disposed adjacent the other wall. The method comprises detecting radiation from the source reflected from the surface using the radiation detector to determine a characteristic of the biological fluid or control.

Claims

1. In combination, an instrument for determining a characteristic of a biological fluid or a control, the instrument comprising a radiation-reflective surface, a first source for irradiating the surface, and a first detector for detecting radiation reflected from the surface, means for determining the characteristic based on the reflected radiation, a cuvette for holding a sample of the biological fluid or control the characteristic of which is to be determined, the cuvette having two opposed walls substantially transparent to the source radiation and reflected radiation, the first source and first detector being disposed adjacent a first one of said two opposed walls and the radiation reflective surface being disposed adjacent a second of said two opposed walls, a second source for irradiating the surface, the first detector detecting radiation from the second source reflected from the surface, the second source positioned to transmit radiation through said two opposed walls for reflection by the surface and transmission back through said two opposed walls to the first detector to indicate whether a sample has reached a first point in the cuvette, the cuvette comprising a region for bearing a code, the instrument further comprising radiation source means for irradiating the code bearing region, detector means for detecting the transmission of radiation through the code bearing region, the radiation source means and detector means mounted adjacent the code bearing region to detect the code, a heater for maintaining the biological fluid or control at a desired temperature, means for mounting the heater adjacent the surface, means for providing power to the heater and means for monitoring the surface temperature and for feeding the monitored temperature back to the means for providing power to the heater, the heater comprising an electrically resistive foil, the surface comprising a first radiation reflective surface of a tile, the tile further comprising a second surface opposite the first surface thereof, and means for mounting the electrically resistive foil to the second surface of the tile.

2. The combination of claim 1 and further comprising a third source for irradiating the surface, the first detector detecting radiation from the third source reflected from the surface, the third source positioned to transmit radiation through said two opposed walls for reflection by the surface and transmission back through said two opposed walls to the first detector to indicate whether a sample has reached a second point in the cuvette.

3. The combination of claim 2 wherein the second point is downstream in the spread of the sample from the first point and the first point is downstream in the spread of the sample from a sample application point.

4. In combination, an instrument for determining a characteristic of a biological fluid or a control, the instrument comprising a radiation-reflective surface, a first source for irradiating the surface, and a first detector for detecting radiation reflected from the surface, means for determining the characteristic based on the reflected radiation, a cuvette for holding a sample of the biological fluid or control the characteristic of which is to be determined, the cuvette having two opposed walls substantially transparent to the source radiation and reflected radiation, the first source and first detector being disposed adjacent a first one of said two opposed walls and the radiation reflective surface being disposed adjacent a second of said two opposed walls, the cuvette comprising a region for bearing a code, the instrument further comprising radiation source means for irradiating the code bearing region, detector means for detecting the transmission of radiation through the code bearing region, the radiation source means and detector means mounted adjacent the code bearing region to detect the code, a user-insertable key having non-volatile memory containing data representative of instrument operating parameters, a port for receiving the key, means for comparing the code to the data representative of instrument operating parameters contained on the user-insertable key, and means for disabling the instrument if the comparison of the code and the data representative of instrument operating parameters contained on the user-insertable key is unfavorable.

5. The combination of claim 4 and further comprising a second source for irradiating the surface, the first detector detecting radiation from the second source reflected from the surface, the second source positioned to transmit radiation through said two opposed walls for reflection by the surface and transmission back through said two opposed walls to the first detector to indicate whether a sample has reached a first point in the cuvette.

6. The combination of claim 5 and further comprising a third source for irradiating the surface, the first detector detecting radiation from the third source reflected from the surface, the third source positioned to transmit radiation through said two opposed walls for reflection by the surface and transmission back through said two opposed walls to the first detector to indicate whether a sample has reached a second point in the cuvette.

7. The combination of claim 6 wherein the second point is downstream in the spread of the sample from the first point and the first point is downstream in the spread of the sample from a sample application point.

8. The combination of claim 4 wherein said radiation source means comprises multiple radiation sources, the detector means having an active region which extends adjacent the code bearing region to detect the transmission of radiation from all of said multiple radiation sources, and means for activating the multiple radiation sources in a predetermined sequence to permit the detection of the code borne by the code bearing region.

9. The combination of claim 8 and further comprising a second source for irradiating the surface, the first detector detecting radiation from the second source reflected from the surface, the second source positioned to transmit radiation through said two opposed walls for reflection by the surface and transmission back through said two opposed walls to the first detector to indicate whether a sample has reached a first point in the cuvette.

10. The combination of claim 9 and further comprising a third source for irradiating the surface, the first detector detecting radiation from the third source reflected from the surface, the third source positioned to transmit radiation through said two opposed walls for reflection by the surface and transmission back through said two opposed walls to the first detector to indicate whether a sample has reached a second point in the cuvette.

11. The combination of claim 10 wherein the second point is downstream in the spread of the sample from the first point and the first point is downstream in the spread of the sample from a sample application point.

12. In combination, an instrument for determining a characteristic of a biological fluid or a control, the instrument comprising a radiation-reflective surface, a first source for irradiating the surface, and a first detector for detecting radiation reflected from the surface, means for determining the characteristic based on the reflected radiation, and a cuvette for holding a sample of the biological fluid or control the characteristic of which is to be determined, the cuvette having two opposed walls substantially transparent to the source radiation and reflected radiation, the first source and first detector being disposed adjacent a first one of said two opposed walls and the radiation reflective surface being disposed adjacent a second of said two opposed walls, the instrument further comprising a second source for irradiating the cuvette and a second detector for detecting when a sample has been applied to a sample application point in the cuvette, the second detector detecting radiation from the second radiation source transmitted through one of said two opposed walls of the cuvette, reflected and transmitted back through said one wall to the second detector, a heater for maintaining the biological fluid or control at a desired temperature means for mounting the heater adjacent the surface, means for providing power to the heater and means for monitoring the surface temperature and for feeding the monitored temperature back to the means for providing power to the heater, the heater comprising an electrically resistive foil, the surface comprising a first radiation reflective surface of a tile, the tile further comprising a second surface opposite the first surface thereof, and means for mounting the electrically resistive foil to the second surface of the tile.

13. The combination of claim 12 and further comprising a third source for irradiating the surface, the first detector detecting radiation from the third source reflected from the surface, the third source positioned to transmit radiation through said two opposed walls for reflection by the surface and transmission back through said two opposed walls to the first detector to indicate whether a sample has reached a first point in the cuvette.

14. The combination of claim 13 wherein the cuvette comprises a region for bearing a code, the instrument further comprising fourth radiation source means for irradiating the code bearing region, third detector means for detecting the transmission of radiation through the code bearing region, the fourth radiation source means and third detector means mounted adjacent the code bearing region to detect the code.

15. In combination, an instrument for determining a characteristic of a biological fluid or a control, the instrument comprising a radiation-reflective surface, a first source for irradiating the surface, and a first detector for detecting radiation reflected from the surface, means for determining the characteristic based on the reflected radiation, and a cuvette for holding a sample of the biological fluid or control the characteristic of which is to be determined, the cuvette having two opposed walls substantially transparent to the source radiation and reflected radiation, the first source and first detector being disposed adjacent a first one of said two opposed walls and the radiation reflective surface being disposed adjacent a second of said two opposed walls, the instrument further comprising a second source for irradiating the cuvette and a second detector for detecting when a sample has been applied to a sample application point in the cuvette, the second detector detecting radiation from the second radiation source transmitted through one of said two opposed walls of the cuvette, reflected and transmitted back through said one wall to the second detector, the cuvette comprising a region for bearing a code, the instrument further comprising radiation source means for irradiating the code bearing region, detector means for detecting the transmission of radiation through the code bearing region, the radiation source means and detector means mounted adjacent the code bearing region to detect the code, a user-insertable key having non-volatile memory containing data representative of instrument operating parameters, a port for receiving the key, means for comparing the code to the data representative of instrument operating parameters contained on the user-insertable key, and means for disabling the instrument if the comparison of the code and the data representative of instrument operating parameters contained on the user-insertable key is unfavorable.

16. The combination of claim 15 and further comprising a third source for irradiating the surface, the first detector detecting radiation from the third source reflected from the surface, the third source positioned to transmit radiation through said two opposed walls for reflection by the surface and transmission back through said two opposed walls to the first detector to indicate whether a sample has reached a first point in the cuvette.

17. The combination of claim 16 wherein the radiation source means comprises multiple radiation sources, the detector means having an active region which extends adjacent the code bearing region to detect the transmission of radiation from all of said multiple radiation sources, and means for activating the multiple radiation sources in a predetermined sequence to permit the detection of the code borne by the code bearing region.

18. In combination, an instrument for determining a characteristic of a biological fluid or a control, the instrument comprising a radiation-reflective surface, a first source for irradiating the surface, and a first detector for detecting radiation reflected from the surface, means for determining the characteristic based on the reflected radiation, and a cuvette for holding a sample of the biological fluid or control the characteristic of which is to be determined, the cuvette having two opposed walls substantially transparent to the source radiation and reflected radiation, the first source and first detector being disposed adjacent a first one of said two opposed walls and the radiation reflective surface being disposed adjacent a second of said two opposed walls, the instrument determining the characteristic by combining the biological fluid or control with particles which are affected by a magnetic field so that the particles become suspended relatively freely in the biological fluid or control, the instrument further comprising means for generating a time-varying magnetic field for causing the particles to be reoriented as the magnetic field varies, with the reorientation changing as the characteristic of the biological fluid or control changes, and means for mounting the means for generating the time-varying magnetic field adjacent the surface, the means for generating a time-varying magnetic field comprising an electromagnet, the electromagnet including a core comprising a first leg, an electrically conductive coil provided on the core for creating a time-varying magnetic flux in the core, a flux return provided at least partly through the core for the time-varying magnetic flux, and a drive circuit coupled to the coil for providing time-varying current flow therein.

19. The combination of claim 18 wherein the first leg and the flux return together comprise a generally E-shaped core of ferromagnetic material, the electrically conductive coil being provided on a middle leg of the generally E-shaped core.

20. The combination of claim 19 and further comprising a permanent bias magnet mounted on the middle leg.

21. The combination of claim 18 and further comprising a second source for irradiating the surface, the first detector detecting radiation from the second source reflected from the surface, the second source positioned to transmit radiation through said two opposed walls for reflection by the surface and transmission back through said two opposed walls to the first detector to indicate whether a sample has reached a first point in the cuvette.

22. The combination of claim 21 wherein the cuvette comprises a region for bearing a code, the instrument further comprising third radiation source means for irradiating the code bearing region, second detector means for detecting the transmission of radiation through the code bearing region, the third radiation source means and second detector means mounted adjacent the code bearing region to detect the code.

23. The combination of claim 21 and further comprising a third source for irradiating the surface, the first detector detecting radiation from the third source reflected from the surface, the third source positioned to transmit radiation through said two opposed walls for reflection by the surface and transmission back through said two opposed walls to the first detector to indicate whether a sample has reached a second point in the cuvette.

24. The combination of claim 23 wherein the cuvette comprises a region for bearing a code, the instrument further comprising fourth radiation source means for irradiating the code bearing region, second detector means for detecting the transmission of radiation through the code bearing region, the fourth radiation source means and second detector means mounted adjacent the code bearing region to detect the code.

25. The combination of claim 23 wherein the second point is downstream in the spread of the sample from the first point and the first point is downstream in the spread of the sample from a sample application point.

26. The combination of claim 25 wherein the cuvette comprises a region for bearing a code, the instrument further comprising fourth radiation source means for irradiating the code bearing region, second detector means for detecting the transmission of radiation through the code bearing region, the fourth radiation source means and second detector means mounted adjacent the code bearing region to detect the code.

27. In combination, an instrument for determining a characteristic of a biological fluid or a control, the instrument comprising a radiation-reflective surface, a first source for irradiating the surface, and a first detector for detecting radiation reflected from the surface, means for determining the characteristic based on the reflected radiation, and a cuvette for holding a sample of the biological fluid or control the characteristic of which is to be determined, the cuvette having two opposed walls substantially transparent to the source radiation and reflected radiation, the first source and first detector being disposed adjacent a first one of said two opposed walls and the radiation reflective surface being disposed adjacent a second of said two opposed walls, the instrument further comprising a second source for irradiating the cuvette and a second detector for detecting when a sample has been applied to a sample application point in the cuvette, the second detector detecting radiation from the second radiation source transmitted through one of said two opposed walls of the cuvette, reflected and transmitted back through said one wall to the second detector, the instrument determining the characteristic by combining the biological fluid or control with particles which are affected by a magnetic field so that the particles become suspended relatively freely in the biological fluid or control, the instrument further comprising means for generating a time-varying magnetic field for causing the particles to be reoriented as the magnetic field varies, with the reorientation changing as the characteristic of the biological fluid or control changes, and means for mounting the means for generating the time-varying magnetic field adjacent the surface, the means for generating a time-varying magnetic field comprising an electromagnet, the electromagnet including a core comprising a first leg, an electrically conductive coil provided on the core for creating a time-varying magnetic flux in the core, a flux return provided at least partly through the core for the time-varying magnetic flux, and a drive circuit coupled to the coil for providing time-varying current flow therein.

28. The combination of claim 27 wherein the first leg and the flux return together comprise a generally E-shaped core of ferromagnetic material, the electrically conductive coil being provided on a middle leg of the generally E-shaped core.

29. The combination of claim 28 and further comprising a permanent bias magnet mounted on the middle leg.

30. The combination of claim 27 and further comprising a third source for irradiating the surface, the first detector detecting radiation from the third source reflected from the surface, the third source positioned to transmit radiation through said two opposed walls for reflection by the surface and transmission back through said two opposed walls to the first detector to indicate whether a sample has reached a first point in the cuvette.

31. The combination of claim 30 wherein the cuvette comprises a region for bearing a code, the instrument further comprising fourth radiation source means for irradiating the code bearing region, third detector means for detecting the transmission of radiation through the code bearing region, the fourth radiation source means and third detector means mounted adjacent the code bearing region to detect the code.

32. In combination, an instrument for determining a characteristic of a biological fluid or a control, the instrument comprising a radiation-reflective surface, a first source for irradiating the surface, and a first detector for detecting radiation reflected from the surface, means for determining the characteristic based on the reflected radiation, and a cuvette for holding a sample of the biological fluid or control the characteristic of which is to be determined, the cuvette having two opposed walls substantially transparent to the source radiation and reflected radiation, the first source and first detector being disposed adjacent a first one of said two opposed walls and the radiation reflective surface being disposed adjacent a second of said two opposed walls, the instrument further comprising a second source for irradiating the surface, the first detector detecting radiation from the second source reflected from the surface, the second source positioned to transmit radiation through said two opposed walls for reflection by the surface and transmission back through said two opposed walls to the first detector to indicate whether a sample has reached a first point in the cuvette, the cuvette further comprising a region for bearing a code, the instrument further comprising radiation source means for irradiating the code bearing region, detector means for detecting the transmission of radiation through the code bearing region, the radiation source means and detector means mounted adjacent the code bearing region to detect the code, the instrument further comprising a heater for maintaining the biological fluid or control at a desired temperature, means for mounting the heater adjacent the surface, means for providing power to the heater and means for monitoring the surface temperature and for feeding the monitored temperature back to the means for providing power to the heater, the means for providing power to the heater comprising a first temperature setpoint control for controlling the heater to maintain the temperature of the biological fluid or control at about said desired temperature, and a second temperature setpoint control for overriding the first temperature setpoint control to heat the biological fluid or control toward a second temperature.

33. The combination of claim 32 wherein the means for providing power to the heater further comprises means for providing a signal that the surface is to be heated from ambient temperature toward the second temperature.

34. The combination of claim 32 wherein the means for providing power to the heater comprises a differential amplifier and a bridge circuit having first, second, third and fourth bridge legs, the differential amplifier including an inverting input terminal and a non-inverting input terminal, means for coupling the inverting input terminal and the first and second legs of the bridge together, and means for coupling the non-inverting input terminal and the third and fourth legs of the bridge together, the second leg of the bridge including the first temperature setpoint control and the fourth leg of the bridge including the means for monitoring the surface temperature.

35. The combination of claim 34 wherein the first temperature setpoint control comprises a potentiometer for setting the desired temperature.

36. The combination of claim 32 and further comprising a third source for irradiating the surface, the first detector detecting radiation from the third source reflected from the surface, the third source positioned to transmit radiation through said two opposed walls for reflection by the surface and transmission back through said two opposed walls to the first detector to indicate whether a sample has reached a second point in the cuvette.

37. The combination of claim 36 wherein the second point is downstream in the spread of the sample from the first point and the first point is downstream in the spread of the sample from a sample application point.

38. In combination, an instrument for determining a characteristic of a biological fluid or a control, the instrument comprising a radiation-reflective surface, a first source for irradiating the surface, and a first detector for detecting radiation reflected from the surface, means for determining the characteristic based on the reflected radiation, and a cuvette for holding a sample of the biological fluid or control the characteristic of which is to be determined, the cuvette having two opposed walls substantially transparent to the source radiation and reflected radiation, the first source and first detector being disposed adjacent a first one of said two opposed walls and the radiation reflective surface being disposed adjacent a second of said two opposed walls, the instrument further comprising a second source for irradiating the cuvette and a second detector for detecting when a sample has been applied to a sample application point in the cuvette, the second detector detecting radiation from the second radiation source transmitted through one of said two opposed walls of the cuvette, reflected and transmitted back through said one wall to the second detector, a heater for maintaining the biological fluid or control at a desired temperature, means for mounting the heater adjacent the surface, means for providing power to the heater and means for monitoring the surface temperature and for feeding the monitored temperature back to the means for providing power to the heater, the means for providing power to the heater comprising a first temperature setpoint control for controlling the heater to maintain the temperature of the biological fluid or control at about said desired temperature, and a second temperature setpoint control for overriding the first temperature setpoint control to heat the biological fluid or control toward a second temperature.

39. The combination of claim 38 wherein the means for providing power to the heater further comprises means for providing a signal that the surface is to be heated from ambient temperature toward the second temperature.

40. The combination of claim 38 wherein the means for providing power to the heater comprises a differential amplifier and a bridge circuit having first, second, third and fourth bridge legs, the differential amplifier including an inverting input terminal and a non-inverting input terminal, means for coupling the inverting input terminal and the first and second legs of the bridge together, and means for coupling the non-inverting input terminal and the third and fourth legs of the bridge together, the second leg of the bridge including the first temperature setpoint control and the fourth leg of the bridge including the means for monitoring the surface temperature.

41. The combination of claim 40 wherein the first temperature setpoint control comprises a potentiometer for setting the desired temperature.

42. The combination of claim 38 and further comprising a third source for irradiating the surface, the first detector detecting radiation from the third source reflected from the surface, the third source positioned to transmit radiation through said two opposed walls for reflection by the surface and transmission back through said two opposed walls to the first detector to indicate whether a sample has reached a first point in the cuvette.

43. The combination of claim 42 wherein the cuvette comprises a region for bearing a code, the instrument further comprising fourth radiation source means for irradiating the code bearing region, third detector means for detecting the transmission of radiation through the code bearing region, the fourth radiation source means and third detector means mounted adjacent the code bearing region to detect the code.

44. The combination of claim 42 wherein the means for providing power to the heater further comprises means for providing a signal that the surface is to be heated from ambient temperature toward the second temperature.

45. The combination of claim 42 wherein the means for providing power to the heater comprises a differential amplifier and a bridge circuit having first, second, third and fourth bridge legs, the differential amplifier including an inverting input terminal and a non-inverting input terminal, means for coupling the inverting input terminal and the first and second legs of the bridge together, and means for coupling the non-inverting input terminal and the third and fourth legs of the bridge together, the second leg of the bridge including the first temperature setpoint control and the fourth leg of the bridge including the means for monitoring the surface temperature.

46. The combination of claim 45 wherein the first temperature setpoint control comprises a potentiometer for setting the desired temperature.

47. In combination, an instrument for determining a characteristic of a biological fluid or a control, the instrument comprising a radiation-reflective surface, a first source for irradiating the surface, and a first detector for detecting radiation reflected from the surface, means for determining the characteristic based on the reflected radiation, and a cuvette for holding a sample of the biological fluid or control the characteristic of which is to be determined, the cuvette having two opposed walls substantially transparent to the source radiation and reflected radiation, the first source and first detector being disposed adjacent a first one of said two opposed walls and the radiation reflective surface being disposed adjacent a second of said two opposed walls, the instrument further comprising a system for supplying power and regulating supplied power from one of multiple power sources to the instrument, the system comprising first and second power sources, first coupling means for selectively coupling the system to the first power source, second coupling means for selectively coupling the system to the second power source, at least one capacitor coupled to the first and second coupling means to store energy from the first and second power sources, and means for comparing a voltage supplied by the first power source to a voltage supplied by the second power source and for controlling the first coupling means to decouple the system from the first power source when the voltage supplied by the second power source exceeds the voltage supplied by the first power source.

48. The combination of claim 47 wherein the first power source comprises a battery provided in the instrument and the second power source comprises an AC-to-DC converter for supplying a voltage having a higher magnitude than the battery'"'"'s voltage when the converter is coupled to a line voltage source.

49. The combination of claim 47 wherein the instrument comprises an ON/OFF switch for energizing the instrument, third coupling means for selectively coupling one of the first and second coupling means to the instrument, means for coupling the third coupling means to the ON/OFF switch, and means for coupling the third coupling means to the first and second coupling means.

50. The combination of claims 47, 48 or 49 and further comprising a controller for orderly de-energizing the instrument, means for storing sufficient energy to permit the controller to orderly de-energize the instrument, means for monitoring the voltage supplied to the instrument by one of the first and second power sources and for signalling the controller to orderly de-energize the instrument if the monitored voltage does not exceed a threshold, fourth means for coupling the controller to the means for storing sufficient energy to permit the controller to orderly de-energize the instrument, fifth means for coupling the means for monitoring the voltage supplied to the instrument by one of the first and second power sources to the first and second coupling means, and sixth means for coupling the means for monitoring the voltage supplied to the instrument by one of the first and second power sources to the controller.