Red blood cell spillover detection technique

• US 5,734,464 A
• Filed: 11/06/1996
• Issued: 03/31/1998
• Est. Priority Date: 11/06/1996
• Status: Expired due to Term

• Current Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Original Assignee: Cobe Cardiovascular Incorporated (LivaNova Plc)
• Inventors: Gibbs, Bruce W.
• Primary Examiner(s): Font, Frank G.
• Assistant Examiner(s): MERLINO, AMANDA H
• Application Number:
  US08/746,109
• Time in Patent Office: 510 Days
• Field of Search: 356/39-42, 128/633
• US Class Current: 356/39
• CPC Class Codes: A61M 1/3622 with a cassette forming partially or totally the blood circuit
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 2205/331 used as turbidity change detectors, e.g. for priming-blood or plasma-hemoglubine-interface detection
• CPC Class Codes: A61M 2205/3313 used specific wavelengths
• CPC Class Codes: G01N 21/3151 using two sources of radiation of different wavelengths G01N21/33 - G01N21/39 take precedence
• CPC Class Codes: G01N 21/532 with measurement of scattering and transmission
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence

Abstract

An apparatus and a method are provided to monitor a generally transparent blood tube at a location that is downstream from a blood separator in order to detect the presence of red blood cells in a tube that is intended to carry a different blood component, for example platelets. A red light source and a green light source are located in relation to the tube so that red light emission and green light emission are directed toward the tube and toward the flowing blood component(s) that is carried within the tube. The red light source produces a red reflection intensity from red blood cells whose magnitude increases as a function of an increase in the concentration of red blood cells. The green light source produces a green reflection intensity from the red blood cells whose magnitude decreases as a function of an increase in the concentration of the red blood cells. These two light reflections are sensed by means of one broadband photodetector, or by two band-specific photodetectors, that are located on the same side of the tube, so as to be responsive only to reflected light. An output is provided by detecting the ratio of the magnitude of the red reflection intensity to the magnitude of the green reflection intensity.

Claims

1. Apparatus for monitoring a light transparent tube adapted to carry flow of a first blood component, and for detecting the undesirable presence or spillover of a second blood component into the tube flow, the apparatus comprising:

a first and a second light source physically located in relation to a side of the tube so that light emission from said first light source and from said second light source are directed toward said side of the tube, said first light source having a first wavelength that is selected to produce a first light reflection intensity from any second blood component that may be present in the tube flow, the first light reflection intensity increasing as a function of an increase in concentration of the second blood component in the tube flow, and said second light source having a second wavelength that is selected to produce a second light reflection intensity from any second blood component that may be present in the tube flow, the second light intensity decreasing as a function of an increase in the concentration of the second blood component in the tube flow;

a light intensity responsive photosensor operable to detect said first light reflection intensity and said second light reflection intensity; and

an output device controlled by said photosensor.

2. The apparatus of claim 1 wherein said output device operates to detect a ratio of said first light reflection intensity to said second light reflection intensity.

3. The apparatus of claim 2 wherein said first light source and said second light source are pulse energized during a first time interval and a second time interval, respectively, and said photosensor operates to detect said first light reflection intensity during said first time interval and to detect said second light reflection intensity during said second time interval.

4. The apparatus of claim 1 wherein the second blood component is red blood cells, wherein said first light source is a red light source, and wherein said second light source is a green light source.

5. The apparatus of claim 4 wherein said output device detects a ratio of said first light reflection intensity to said second light reflection intensity.

6. The apparatus of claim 5 wherein the first blood component comprises platelets.

7. The apparatus of claim 6 wherein said first light source and said second light source are energized during a first time interval and a second time interval, respectively, wherein said photosensor operates to detect said first light reflection intensity during said first time interval and to detect said second light reflection intensity during said second time interval, and wherein said first light source and said second light source are pulse energized.

8. The apparatus of claim 1 wherein said first light source, said second light source, and said photosensor are all physically located adjacent to the same side of the tube, to facilitate the physical loading of the tube onto the apparatus.

9. The apparatus of claim 8 wherein said output device detects a ratio of said first light reflection intensity to said second light reflection intensity.

10. A method of monitoring a non-red blood cell and light transparent tube and detecting the quantity of red blood cells that may be flowing in the tube, comprising the steps of:

directing red light toward a side of the tube;

directing green light toward a side of the tube;

detecting a red light reflection intensity from red blood cells that may be flowing within the tube;

detecting a green light reflection intensity from red blood cells that may be flowing within the tube; and

providing an output by detecting a ratio of said red light reflection intensity to said green light reflection intensity.

11. The method of claim 10 wherein said step of providing an output includes the steps of;

providing a threshold value, and

comparing said ratio to said threshold value.

12. The method of claim 10 wherein said step of directing said red light toward the tube and said step of detecting said red light reflection intensity occur during a first time interval, and wherein said step of directing said green light toward the tube and said step of detecting said green light reflection intensity occur during a second time interval that is different than said first time interval.

13. The method of claim 12 wherein said step of provided an output includes the steps of:

providing a threshold value, and

comparing said ratio to said threshold value.

14. The method of claim 10 wherein said side of the tube toward which red light is directed, and said side of the tube toward which green light is directed, comprise a common side of the tube.

15. The method of claim 10 wherein said side of the tube toward which red light is directed, and said side of the tube toward which green light is directed, comprise opposite sides of the tube.

16. A method sensing red blood cell spillover into a non-red blood tube, comprising the steps of:

providing a light transparent empty tube;

providing a photosensor to view an external portion of one side of said tube;

determining a first output of said photosensor when said photosensor views said external portion of said empty tube;

providing a red light source that is located to illuminate said external portion of said one side of said tube with red light when said red light source is energized;

providing a green light source that is located to illuminate said external portion of said one side of said tube with green light when said green light source is energized;

determining a second output of said photosensor while said photosensor views said external portion of said empty tube, and while only said red light source is energized;

determining a third output of said photosensor while said photosensor views said external portion of said empty tube, and while only said green light source is energized;

establishing a compensated red photosensor output by subtracting said first output for said second output;

establishing a compensated green photosensor output by subtracting said first output for said third output;

providing ratio determining means;

initializing said ratio determining means by utilizing said ratio determining means to establish a ratio equals one output from said ratio determining means when said ratio determining means determines the ratio of said compensated green photosensor output to said compensated red photosensor output;

filling said tube with a non-red blood cell sample that is normally devoid of red blood cells;

energizing only said green light source, to thereby direct green light toward said external portion of said filled tube;

determining a fourth output of said photosensor as said photosensor views green light that is reflected from said non-red blood sample within said filled tube while only said green light source is energized;

energizing only said red light source, to thereby direct red light toward said external portion of said filled tube;

determining a fifth output of said photosensor as said photosensor views red light that is reflected from said non-red blood sample within said filled tube while only said red light source is energized; and

utilizing said initialized ratio determining means to provide a red blood cell spillover output as a function of a ratio of said fifth output and said fourth output.

17. Apparatus for continuously monitoring the flow of a non-red blood cell blood component for the occurrence of a spillover of red blood cells, comprising:

a generally elongated and light transparent tube for carrying the flow of a non-red blood cell blood component, said tube having a generally elongated tube axis;

a red light source located to one side of the tube and positioned to direct a beam of red light at an angle of about 45 degrees to said tube axis, and toward an external portion of said one side of the tube, when said red light source is energized;

a green light source located to said one side of the tube and positioned to direct a beam of green light at an angle of about 45 degrees to said tube axis, and toward said external portion of said one side of the tube when said red light source is energized;

a photodetector that is responsive to red light reflection and to green light reflection, said photodetector being located to said one side of the tube and positioned to view said external portion of said one side of the tube along a view axis that extends generally normal to said tube axis;

energizing means for alternately pulse energizing said red light source during a first time interval and said green light source during a second time interval;

ratio determining means responsive to a red light reflection output from said photodetector during said first time interval, and to a green light reflection output from said photodetector during said second time interval; and

red blood spillover output means controlled by said ratio determining means as a function of a ratio of said red light reflection output to said green light reflection output.

18. The apparatus of claim 17 wherein said energizing means provides generally equal time periods of pulse energizing of said red light source and said green light source.

19. The apparatus of claim 18 wherein said red light source and said green light source comprise light emitting diodes.

20. The apparatus of claim 19 wherein said light emitting diodes are energized at a frequency of about 2 Khz.

21. The apparatus of claim 20 wherein the tube is a component of a disposable set and wherein the photosensor is further operable to detect a third reflection intensity and a fourth reflection intensity before a blood component is carried in said tube and to determine a configuration of the disposable set based on said third and fourth reflection intensities.