Fluid handling cassette with a fluid control interface and sample separator

• US 7,907,985 B2
• Filed: 12/21/2005
• Issued: 03/15/2011
• Est. Priority Date: 02/14/2005
• Status: Expired due to Fees

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Keenan, Richard, Gable, Jennifer H., Braig, James R., Zheng, Peng, Li, Kenneth I., Wechsler, Mark
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US11/316,676
• Publication Number:
  US 20110011167A1
• Time in Patent Office: 1,910 Days
• Field of Search: 600/573, 600/576, 604/6.16, 604/19, 604/66, 422/72, 436/45
• US Class Current: 600/310
• 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 that is removably engageable with a bodily fluid analyzer is provided. The module may comprise a fluid handling element, and a fluid component separator that is accessible via the fluid handling element and configured to separate at least one component of a bodily fluid transported to the fluid component separator. The fluid handling element may have at least one control element interface.

Claims

1. A fluid handling module removably engageable with a bodily fluid analyzer, said module comprising:

a disposable fluid handling element configured to prevent fluid contact with the non-disposable bodily fluid analyzer, the analyzer having plural fluid control element actuators, the fluid handling element configured to interface with the analyzer at an analyzer interface surface, the disposable fluid handling element comprising;

multiple fluid passageways comprising tubes and having no exits for fluid within the analyzer interface surface area, wherein fluid is prevented from contacting the analyzer;

a syringe configured to receive a fluid, the syringe having a syringe control element recessed in an opening in the analyzer interface surface and configured to engage an actuator on the analyzer;

a valve configured to engage at least a portion of at least one fluid passageway, the valve having a valve control element recessed in an opening in the analyzer interface surface and configured to engage an actuator on the analyzer; and

an integrated fluid component separator mounted for rotation on the disposable fluid handling element, the separator configured to separate the bodily fluid into multiple components for analysis, the separator further comprising;

a disposable rotor;

a disposable container mounted on the disposable rotor, the disposable container comprising an analysis chamber having a window configured for positioning in an optical path for analysis; and

a separator control element recessed in an opening in the analyzer interface surface and configured to mechanically engage the analyzer to facilitate input of fluid into the analysis chamber and rotation of the rotor;

wherein each such opening in the disposable fluid handling element at least partially registers the respective control element on the fluid handling element with the actuator.

2. The system of claim 1, wherein said fluid handling element comprises a flexible tube.

3. The module of claim 1, wherein said fluid component separator further comprises a membrane.

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

5. A fluid handling and analysis system comprising:

a main analysis and control instrument; and

a disposable fluid handling module removably engageable with said main instrument;

said main instrument comprising;

a bodily fluid analyzer; and

at least one control element, the control element comprising at least one actuator configured to control fluid flow through the fluid handling module without directly contacting the fluid;

said fluid handling module comprising;

multiple fluid passageways configured to remove a bodily fluid from a patient and to prevent contact by the fluid with the main instrument;

an integrated fluid component separator that is configured to separate bodily fluid into multiple subcomponents for analysis the separator mounted for rotation on the disposable fluid handling module, the separator further comprising an analysis chamber having a window configured for positioning in an optical path for analysis, the optical path being formed on the bodily fluid analyzer of the main instrument;

at least one fluid handling element coupled to said fluid component separator; and

at least one control interface coupled to the fluid handling element configured to engage said at least one actuator when said main instrument and said fluid handling module are engaged.

6. The system of claim 5, wherein said fluid handling module comprises a cassette.

7. The system of claim 5, wherein said fluid handling element comprises a flexible tube.

8. The system of claim 5, wherein said at least one actuator comprises a valve actuator.

9. The system of claim 5, wherein said at least one fluid handling element further comprises a container portion of a syringe.

10. The system of claim 5, wherein said at least one protruding control element is selected from a group consisting of a syringe drive, a handle portion of the syringe, a valve actuator, a pinch valve actuator, a pump actuator or a piston.

11. The system of claim 5, wherein said fluid handling module encloses said at least one fluid handling element, said fluid handling module further comprising at least one opening operably positioned to allow access to said at least one protruding control element.

12. The system of claim 5, wherein said fluid handling module comprises said fluid component separator mounted in said module body so as to be at right angles with respect to said module body.

13. The system of claim 5, wherein said fluid component separator comprises a centrifuge rotor configured to engage a centrifuge motor of said main instrument.

14. The system of claim 5, wherein said fluid component separator comprises a membrane.

15. The system of claim 5, wherein said fluid component separator comprises a centrifuge.

16. The system of claim 5, wherein said fluid component separator comprises a centrifuge rotor.

17. The system of claim 16, wherein said centrifuge rotor is configured to engage a centrifuge drive located on said main instrument.

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

attaching a disposable fluid handling module to a main analysis and control instrument, wherein;

said fluid handling module comprises;

at least one disposable fluid handling element further comprising a fluid passageway;

at least one control element interface; and

a fluid component separator integrated onto said disposable fluid handling module and accessible via said fluid handling element, wherein said fluid component separator is configured to separate the bodily fluid into multiple subcomponents, said separator further comprising an analysis chamber positioned in an optical path of a fluid analyzer on said main analysis and control instrument;

engaging said at least one control element interface of said fluid handling module with said at least one control element of said main instrument through an opening in the fluid handling module;

drawing a sample of said bodily fluid from said patient into said fluid handling module by actuating said at least one control element;

controlling fluid flow between said at least one fluid handling element and said fluid component separator with said at least one control element;

separating the sample of the bodily fluid into multiple subcomponents with the fluid component separator, at least one subcomponent remaining in the analysis chamber for optical analysis; and

analyzing at least one of the multiple subcomponents with said body fluid analyzer to determine the concentration of an analyte.

19. The method of claim 18, wherein said at least one fluid handling element comprises a flexible tube.

20. The method of claim 18, wherein said fluid handling module comprises a cassette.

21. The method of claim 18, further comprising connecting said fluid handling module to said bodily fluid of said patient, wherein said drawing a sample of said bodily fluid from said patient into said fluid handling module comprises withdrawing a sample of said bodily fluid by actuating a syringe pump.

22. The method of claim 18, wherein said fluid handling module further comprises a sample cell in fluid communication with said fluid component separator, said method further comprising:

holding at least a portion of said multiple subcomponents of said bodily fluid in said sample cell; and

with said bodily fluid analyzer, spectroscopically analyzing at least one of said multiple subcomponents of bodily fluid in said sample cell.

23. The method of claim 18, wherein:

said at least one fluid handling element comprises a syringe;

said at least one control element further comprises a syringe drive; and

said engaging comprises interfacing said syringe with said syringe drive.

24. A disposable fluid handling cassette configured to interface with a non-disposable analyzer, the cassette comprising:

multiple fluid passageways comprising tubes configured to prevent bodily fluid from contacting the analyzer;

an analyzer interface surface having plural fluid control element actuators therein, each fluid control element actuator configured to interface with an actuator on the non-disposable analyzer;

an integrated fluid component separator mounted on the cassette, the separator configured to separate the bodily fluid into multiple subcomponents for analysis, the separator further comprising;

an analysis chamber for positioning at least one of the bodily fluid components in an optical path for analysis;

a separator control element positioned in the analyzer interface surface and configured to mechanically engage the analyzer;

a fluid inlet in fluid communication with said passageways and said separator for providing bodily fluid to the separator; and

a fluid outlet for removing the analyzed bodily fluid from the separator; and

a waste container in fluid communication with said separator fluid outlet.

25. The disposable fluid handling cassette of claim 24, wherein the separator fluid inlet is engageable with a movable fluid nozzle mounted on the cassette.