Fluid dose, flow and coagulation sensor for medical instrument

• US 5,522,255 A
• Filed: 08/31/1993
• Issued: 06/04/1996
• 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 (Roche Holding AG)
• 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): Sykes, Angela D.
• Assistant Examiner(s): NASSER, ROBERT L
• Application Number:
  US08/114,913
• Time in Patent Office: 1,008 Days
• Field of Search: 73/64.41-64.43, 73/54.08, 73/54.09, 73/54.12, 73/54.15, 422/73, 436/69, 356/39, 128/633, 128/664-6
• US Class Current: 73/64.43
• 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, C12Q1/56
• 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 coagulation characteristic of blood, a blood fraction or a control comprise a radiation-reflective surface, a first source for irradiating the surface, and a first detector for detecting radiation reflected from the surface. A cuvette holds a sample of the blood, blood fraction or control the coagulation characteristic of which is to be determined. The cuvette has two opposed walls substantially transparent to the source radiation and reflected radiation. The first source and first detector are disposed adjacent a first one of the two opposed walls and the radiation reflective surface is disposed adjacent a second of the two opposed walls.

Claims

1. In combination, an instrument for determining a characteristic of a biological fluid or a control comprising a radiation-reflective surface, a first source for irradiating the surface, and a first detector for detecting radiation reflected from the surface, a heater comprising an electrically resistive foil 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 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, 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.

2. The combination of claim 1 wherein the instrument further comprises 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.

3. The combination of claim 2 wherein the instrument determines 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.

4. The combination of claim 2 wherein the cuvette comprises a region for bearing a code, the instrument further comprising third radiation source means for irradiating the code bearing region, third detector means for detecting the transmission of radiation through the code bearing region, the third radiation source means and third detector means mounted adjacent the code bearing region to detect the code.

5. The combination of claim 4 and further comprising 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.

6. The combination of claim 4 or 5 wherein said third source means comprises multiple radiation sources, the third 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.

7. The combination of claim 1 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.

8. The combination of claim 7 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.

9. The combination of claim 8 wherein the instrument determines the characteristic of the biological fluid or control 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.

10. The combination of claim 8 and further comprising 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.

11. The combination of claim 8 or 10 wherein said third radiation source means comprises multiple radiation sources, the second 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.

12. The combination of claim 7 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.

13. The combination of claim 12 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.

14. The combination of claim 13 wherein the instrument determines the characteristic of the biological fluid or control 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.

15. The combination of claim 13 and further comprising 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 13 or 15 wherein said fourth radiation source means comprises multiple radiation sources, the second 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.

17. The combination of claim 12 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 the sample application point.

18. The combination of claim 17 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.

19. The combination of claim 18 wherein the instrument determines the characteristic by combining 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.

20. The combination of claim 18 and further comprising 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.

21. The combination of claim 18 or 20 wherein said fourth radiation source means comprises multiple radiation sources, the second 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.

22. The combination of claim 1 wherein the instrument determines 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.

23. The combination of claim 1 wherein the cuvette comprises a region for bearing a code, the instrument further comprising second radiation source means for irradiating the code bearing region, second detector means for detecting the transmission of radiation through the code bearing region, the second radiation source means and second detector means mounted adjacent the code bearing region to detect the code.

24. The combination of claim 23 and further comprising 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.

25. The combination of claim 23 or 24 wherein said second radiation source means comprises multiple radiation sources, the second 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.

26. In combination, an instrument for determining a characteristic of a biological fluid or a control comprising a radiation-reflective surface, a first source for irradiating the surface, and a first detector for detecting radiation reflected from the surface, 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 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, and a fourth source for irradiating the surface, the first detector detecting radiation from the fourth source reflected from the surface, the fourth 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.

27. The combination of claim 26 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 the sample application point.

28. The combination of claim 27 wherein the cuvette comprises a region for bearing a code, the instrument further comprising fifth radiation source means for irradiating the code bearing region, third detector means for detecting the transmission of radiation through the code bearing region, the fifth radiation source means and third detector means mounted adjacent the code bearing region to detect the code.

29. The combination of claim 28 and 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.

30. The combination of claim 29 wherein the heater comprises an electrically resistive foil, the surface comprises 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.

31. The combination of claim 28 wherein the instrument determines the characteristic by combining 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.

32. The combination of claim 28 and further comprising 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.

33. The combination of claim 28 or 32 wherein said fifth radiation source means comprises multiple radiation sources, the third 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.

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

35. The combination of claim 34 or 28 and further comprising 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.

36. The combination of claim 35 wherein said fifth radiation source means comprises multiple radiation sources, the third 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.

37. The combination of claim 34 and 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.

38. The combination of claim 37 wherein the heater comprises an electrically resistive foil, the surface comprises 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.

39. The combination of claim 34 wherein said fifth radiation source means comprises multiple radiation sources, the third 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.

40. The combination of claim 34 wherein the instrument determines the characteristic of the biological fluid or control 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.

41. The combination of claim 26 wherein the instrument determines the characteristic of the biological fluid or control 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.