Fluid handling cassette having a spectroscopic sample cell

• US 7,481,787 B2
• Filed: 12/21/2005
• Issued: 01/27/2009
• Est. Priority Date: 02/14/2005
• Status: Expired due to Fees

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Gable, Jennifer H., Braig, James R., Zheng, Peng, Li, Kenneth I., Wechsler, Mark, Keenan, Richard
• Primary Examiner(s): Griffin; Walter D
• Assistant Examiner(s): Ramdhanie; Bobby
• Application Number:
  US11/316,672
• Publication Number:
  US 20060188407A1
• Time in Patent Office: 1,133 Days
• Field of Search: 422/101, 604/19
• US Class Current: 604/19
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/0086 using infrared radiation
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14517 for sweat
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150755 : Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150862 : intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/150992 : Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/153 : Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/155 : Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/4839 : combined with drug delivery
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2230/20 : Blood composition characteristics
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 5/14212 : Pumping with an aspiration and an expulsion action
• CPC Class Codes: A61M 5/14232 : Roller pumps
• CPC Class Codes: A61M 5/16854 : by monitoring line pressure
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/365 : Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626
• CPC Class Codes: A61M 5/38 : using hydrophilic or hydrophobic filters
• CPC Class Codes: G01N 2021/3595 : using FTIR
• CPC Class Codes: G01N 21/03 : Cuvette constructions
• CPC Class Codes: G01N 21/3577 : for analysing liquids, e.g. polluted water
• CPC Class Codes: G01N 2201/02 : Mechanical
• CPC Class Codes: G01N 2201/061 : Sources
• CPC Class Codes: Y10T 137/4478 : Line condition change responsive
• CPC Class Codes: Y10T 137/7722 : Line condition change responsive valves
• CPC Class Codes: Y10T 137/86485 : Line condition change responsive release of valve
• CPC Class Codes: Y10T 436/111666 : Utilizing a centrifuge or compartmented rotor
• CPC Class Codes: Y10T 436/2575 : Volumetric liquid transfer

Abstract

A fluid handling module is configured for removable engagement with a reusable main fluid handling instrument. The module includes a module housing and a first fluid passageway extending from the module housing. The first fluid passageway has a patient end remote from the housing. The first fluid passageway is configured to provide fluid communication with a bodily fluid in a patient. A fluid component separator is in fluid communication with the first fluid passageway. The fluid component separator is configured to separate at least one component from a portion of the bodily fluid drawn from the patient. A spectroscopic sample cell is configured to hold at least a portion of the first component.

Claims

1. A fluid handling module configured for removable engagement with a reusable main fluid handling instrument, said module comprising:

a module housing;

a first fluid passageway extending from said module housing, said first fluid passageway having a patient end remote from said housing, said first fluid passageway configured to provide fluid communication with a bodily fluid in a patient;

a fluid component separator in fluid communication with said first fluid passageway, said fluid component separator configured to be rotated about an axis of rotation to separate at least a first component of said bodily fluid from a second component of said bodily fluid drawn from said patient;

a spectroscopic sample cell disposed on said fluid component separator;

a spectroscopic sample chamber operatively coupled to the sample cell, the spectroscopic sample chamber comprising an analysis region for containing the first component of said bodily fluid and a non-analysis region for containing the second component of said bodily fluid, the analysis region being located between the axis of rotation and the non-analysis region; and

a source of flush fluid in fluid communication with said spectroscopic sample chamber, the source of flush fluid being adapted displace the first and second components out of the spectroscopic sample chamber to permit a plurality of samples of the bodily fluid to be analyzed.

2. The fluid handling module of claim 1, wherein said fluid component separator further comprises a filter in fluid communication with said first fluid passageway.

3. The fluid handling module of claim 1, wherein said fluid component separator comprises a centrifuge.

4. The fluid handling module of claim 1, wherein said fluid component separator comprises a centrifuge rotor which is configured to engage a centrifuge drive located on said main fluid handling instrument.

5. The fluid handling module of claim 4, wherein said sample cell is located on said centrifuge rotor.

6. The fluid handling module of claim 1, wherein said sample cell is in fluid communication with said fluid component separator.

7. The fluid handling module of claim 1, wherein said sample cell comprises at least one window.

8. The fluid handling module of claim 7, wherein said window allows infrared radiation to pass into said sample cell.

9. The fluid handling module of claim 1, wherein said sample cell comprises at least two windows.

10. The fluid handling module of claim 9, wherein said windows allow infrared radiation to pass through said sample cell.

11. The fluid handling module of claim 1, wherein said sample cell is reagentless.

12. A system for measuring an analyte in a bodily fluid, said system comprising:

a main analysis and control instrument comprising an analyte detection system; and

a fluid handling module removably engageable with said main instrument, the module being adapted to measure the analyte in a plurality of samples of the bodily fluid before being removed, said fluid handling module further comprising;

a centrifuge rotor which is rotatable about a centrifuge axis; and

a sample cell located on said rotor, said sample cell being rotatable with said rotor about said centrifuge axis;

said sample cell comprising an input fluid passageway in fluid communication with the instrument for communicating a first sample of the bodily fluid into the sample cell, a sample chamber for containing the first sample, and an output fluid passageway for conveying the first sample out of the chamber following analyte detection;

the centrifuge rotor adapted to provide a first sample component and a second sample component, the sample chamber adapted to contain both first and second sample components of said first sample,

said rotor and said sample cell being rotatable to a measurement position in which said sample cell operatively engages said analyte detection system such that only one of the first or second sample components is analyzed, and a flush fluid for separating the first sample from a second sample.

13. The system of claim 12, wherein said fluid handling module further comprises a centrifuge drive motor configured to rotate said centrifuge rotor.

14. The system of claim 12, wherein said main analysis and control instrument further comprises a centrifuge drive motor and said fluid handling module further comprises a centrifuge drive motor interface configured to interface with said drive motor.

15. The system of claim 12, wherein said analyte detection system further comprises a source of electromagnetic radiation and a detector configured to detect said electromagnetic radiation, and wherein said sample cell is between said electromagnetic radiation source and said electromagnetic detector when said rotor is in said measurement position.

16. The system of claim 12, wherein said analyte detection system defines an optical axis, and where said sample cell is located on said optical axis when in said measurement position.

17. The system of claim 12, wherein said sample cell comprises at least one window.

18. The system of claim 17, wherein said window allows electromagnetic radiation to pass into said sample cell.

19. The system of claim 12, wherein said sample cell comprises at least two windows.

20. The system of claim 19, wherein said windows allow infrared radiation to pass through said sample cell.

21. The system of claim 12, wherein said sample cell is reagentless.

22. A method for extracting and analyzing a bodily fluid of a patient, said method comprising:

attaching a fluid handling module to a reusable fluid handling instrument, wherein;

said fluid handling module comprises a fluid component separator, a spectroscopic sample cell and a first fluid passageway; and

said reusable fluid handling instrument comprises an analyte detection system;

drawing a volume of a bodily fluid from said patient into said first fluid passageway;

with said fluid component separator, separating a first component from said volume of bodily fluid drawn from said patient;

holding at least a portion of said first component of said bodily fluid in said spectroscopic sample cell;

with said analyte detection system, analyzing in said sample cell said first component to determine a concentration of an analyte; and

conveying the first component away from the spectroscopic sample cell after analysis.

23. The method of claim 22, further comprising aligning said spectroscopic sample cell with said analyte detection system.

24. The method of claim 23, wherein:

said spectroscopic sample cell comprises an optical window;

said analyte detection system comprises a source of electromagnetic radiation and an detector of electromagnetic radiation; and

said aligning comprises positioning said optical window of spectroscopic sample cell between said electromagnetic source and said detector.

25. The method of claim 23, wherein said main instrument further comprises a fluid component separator drive motor and said attaching comprises interfacing said fluid component separator with said drive motor.

26. The method of claim 25, wherein said fluid component separator comprises a centrifuge rotor and said separating comprises rotating said centrifuge rotor about said centrifuge axis.

27. The method of claim 25, wherein said spectroscopic sample cell is located on said centrifuge rotor and said aligning comprises rotating said centrifuge rotor to a measurement position in which said sample cell operatively engages said analyte detection system.

28. A system for measuring an analyte in a bodily fluid, said system comprising:

a main analysis and control instrument comprising an analyte detection system; and

a fluid handling module removably engageable with said main instrument, the fluid handling module being adapted to facilitate measurement of the analyte in a plurality of samples of the bodily fluid being removed, said fluid handling module further comprising;

a sample handling device; and

a sample cell operatively coupled with said sample handling device;

said sample cell comprising a sample chamber for containing a first sample, an input fluid passageway for communicating the first sample into the sample chamber, and an output fluid passageway for communicating the first sample out of the sample chamber following analyte detection in the first sample, said output fluid passageway adapted to permit a subsequent sample to be admitted into the sample chamber;

the sample handling device adapted to separate at least a first sample component of said first sample from at least a second sample component of said first sample, the sample chamber adapted to contain at least one of the first and second sample components of said first sample;

said sample cell having a measurement position in which said sample cell operatively engages said analyte detection system such that at least one of the first sample component and the second sample component is analyzed.

29. The system of claim 28, wherein said sample handling device comprises a centrifuge rotor which is rotatable about a centrifuge axis, said sample chamber being located on said rotor.

30. The system of claim 28, wherein said sample handling device comprises a filter located upstream of said sample chamber.

31. The system of claim 28, wherein said analyte detection system defines an optical axis, and where said sample cell is located on said optical axis when in said measurement position.

32. The system of claim 28, wherein said sample cell comprises at least one window adapted to permit electromagnetic radiation to pass therethrough into the sample chamber.

33. The system of claim 28, wherein said sample cell is reagentless.

34. The system of claim 28, wherein the sample cell comprises a flushing fluid passageway configured to convey a flushing fluid through the sample chamber after a first measurement and prior to subsequent measurements.

35. The system of claim 28, wherein the sample handling device comprises a blood component separator in fluid communication with said sample cell.

36. The system of claim 28, wherein the sample handling device comprises an electrolytic device.