Fluid dose, flow and coagulation sensor for medical instrument

• US 6,189,370 B1
• Filed: 06/17/1998
• Issued: 02/20/2001
• Est. Priority Date: 08/31/1993
• Status: Expired due to Term

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Roche Diagnostics 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): Nasser, Robert L.
• Application Number:
  US09/098,708
• Time in Patent Office: 979 Days
• Field of Search: 600/368, 600/369, 356/39-41, 73/530.1, 73/644.3, 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, C12Q1/56
• 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 for determining a characteristic of a biological fluid or a control includes a radiation-reflective surface, a first source for irradiating the surface, and a first detector for detecting radiation reflected from the surface. A cuvette for use with the instrument holds a sample of the biological fluid or control the 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 said two opposed walls and the radiation reflective surface is disposed adjacent a second of said 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, 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, 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 including a region for bearing a code, the instrument further comprising one or more third radiation sources for irradiating the code bearing region, one or more second detectors for detecting the transmission of radiation through the code bearing region, the third radiation source or sources and second detector or detectors mounted adjacent the code bearing region to detect the code, the insturment further including 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, wherein the instrument further comprises a fourth source for irradiating the cuvette and a third detector for detecting when a sample has been applied to a sample application point in the cuvette, the third detector detecting radiation from the fourth radiation source transmitted through one of said two opposed walls of the cuvette, reflected and transmitted back through said one wall to the third detector.

3. 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 cuvette comprising a region for bearing a code, the instrument further comprising multiple second radiation sources for irradiating the code bearing region, a second detector for detecting the transmission of radiation through the code bearing region, the second radiation sources and second detector mounted adjacent the code bearing region to detect the code, the second detector having an active region which extends adjacent the code bearing region to detect the transmission of radiation from all of said second radiation sources, and means for activating the second radiation sources in a predetermined sequence to permit the detection and determination of the code borne by the code bearing region, 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.

4. The combination of claim 3 wherein the instrument further comprises a third source for irradiating the cuvette and a third detector for detecting when a sample has been applied to a sample application point in the cuvette, the third detector detecting radiation from the third radiation source transmitted through one of said two opposed walls of the cuvette, reflected and transmitted back through said one wall to the third detector.

5. 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, 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 one or more third radiation sources for irradiating the code bearing region, one or more second detectors for detecting the transmission of radiation through the code bearing region, the third radiation source or sources and second detector or detectors 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.

6. The combination of claim 5 wherein the instrument further comprises a fourth source for irradiating the cuvette and a third detector for detecting when a sample has been applied to a sample application point in the cuvette, the third detector detecting radiation from the fourth radiation source transmitted through one of said two opposed walls of the cuvette, reflected and transmitted back through said one wall to the third detector.

7. 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, 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 multiple third radiation sources for irradiating the code bearing region, a second detector for detecting the transmission of radiation through the code bearing region, the third radiation sources and second detector mounted adjacent the code bearing region to detect the code, the second detector having an active region which extends adjacent the code bearing region to detect the transmission of radiation from all of said third radiation sources, and means for activating the third radiation sources in a predetermined sequence to permit the detection and determination of the code borne by the code bearing region, 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.

8. The combination of claim 7, wherein the instrument further comprises a fourth source for irradiating the cuvette and a third detector for detecting when a sample has been applied to a sample application point in the cuvette, the third detector detecting radiation from the fourth radiation source transmitted through one of said two opposed walls of the cuvette, reflected and transmitted back through said one wall to the third detector.