Bodily fluid composition analyzer with disposable cassette

• US 8,936,755 B2
• Filed: 03/16/2012
• Issued: 01/20/2015
• Est. Priority Date: 03/02/2005
• Status: Expired due to Fees

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Gable, Jennifer H., Braig, James R., Li, Kenneth I., Wechsler, Mark, Zheng, Peng, Keenan, Richard
• Primary Examiner(s): Sasaki, Shogo
• Application Number:
  US13/423,077
• Publication Number:
  US 20120232362A1
• Time in Patent Office: 1,040 Days
• Field of Search: 702/19, 702/22, 702/31, 436/180, 422/105, 422/81, 422/509, 422/516, 422/521, 137/247.15, 137/624.27, 137/455, 604/131
• US Class Current: 422/105
• 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 5/14525 using microdialysis
• 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 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• 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 5/150755 : Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• 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 5/157 : 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 21/251 : Colorimeters; Construction thereof
• 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

Disclosed is an apparatus for analyzing the composition of bodily fluid. The apparatus can include a fluid handling network including a patient end configured to maintain fluid communication with a bodily fluid in a patient and a pump unit in operative engagement with the fluid handling network. The pump unit can have an infusion mode, in which the pump unit is operable to deliver infusion fluid to the patient through the patient end, and a sample draw mode, in which the pump unit is operable to draw a sample of the bodily fluid from the patient through the patient end. The apparatus can include a spectroscopic analyzer positioned to analyze at least a portion of the sample; a processor in communication with or incorporated into the spectroscopic analyzer; and stored program instructions executable by the processor to obtain measurements of two or more properties of the sample.

Claims

1. An apparatus for analyzing the composition of bodily fluid, the apparatus comprising:

a main instrument comprising;

a housing and at least one protrusion extending from the housing;

a fluid handling network that comprises fluid passageways and junctions, wherein the fluid handling network includes a patient end capable of maintaining fluid communication with a bodily fluid in a patient;

a controller in operative engagement with the fluid handling network, the controller having an infusion mode in which the controller is configured to cause the fluid handling network to deliver infusion fluid to the patient through the patient end, and a sample draw mode in which the controller is configured to cause the fluid handling network to draw a sample of the bodily fluid from the patient through the patient end;

a fluid analyzer positioned to analyze at least a portion of the sample; and

a processor in communication with or incorporated into the fluid analyzer;

said processor configured to execute stored program instructions;

to obtain measurements of two or more properties of the portion of the sample;

and

a disposable fluid handling cassette removably engageable with the fluid analyzer, the cassette comprising;

at least one fluid passageway capable of receiving bodily fluid from the patient via the fluid handling network;

a sample measurement location positioned to allow analysis of the bodily fluid by the fluid analyzer and coinciding with an analysis region of the fluid analyzer, wherein the sample measurement location is configured to hold the sample in place during analysis by the fluid analyzer;

an input fluid passageway capable of allowing the sample to flow to the sample measurement location from the fluid handling network;

an output fluid passageway capable of allowing the sample to flow away from the sample measurement location; and

at least one cassette engagement interface capable of engaging the at least one protrusion of the main instrument and to place the controller in operative engagement with the disposable fluid handling cassette while the disposable fluid handling cassette is installed in the fluid analyzer.

2. The apparatus of claim 1, further comprising a fluid component separator, wherein the disposable fluid handling cassette comprises a separator interface capable of engaging the fluid component separator that is configured to separate the bodily fluid into multiple subcomponents for analysis.

3. The apparatus of claim 1, wherein a sample chamber is capable of holding the sample at the sample measurement location in a non-flowing state during analysis by the fluid analyzer.

4. The apparatus of claim 1, wherein the controller controls at least one control element capable of controlling fluid flow through the disposable fluid handling cassette.

5. The apparatus of claim 4 wherein the at least one 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 and a piston.

6. The apparatus of claim 2, wherein the fluid component separator is integrated with the disposable fluid handling cassette.

7. The apparatus of claim 2, wherein the fluid component separator is a part of the fluid analyzer.

8. The apparatus of claim 2, wherein the separator interface comprises a centrifuge rotor capable of engaging a centrifuge motor.

9. The apparatus of claim 2, wherein the fluid component separator comprises a centrifuge.

10. The apparatus of claim 2, wherein the fluid component separator comprises a centrifuge rotor.

11. The apparatus of claim 1, wherein the fluid analyzer comprises an optical analyzer, and wherein the optical analyzer comprises a light source and a detector positioned to receive light emitted by the light source.

12. The apparatus of claim 11, wherein the detector is connected with the controller, and wherein the detector is capable of performing spectroscopic analysis to determine two or more properties of the sample.

13. The apparatus of claim 11, wherein the light passes through the sample at the sample measurement location and is received by the detector when the sample is analyzed by the analyzer.

14. The apparatus of claim 1, wherein the apparatus comprises a main instrument, wherein the at least one protrusion protrudes from the main instrument, and wherein the protrusion comprises a pinch valve capable of controlling the flow in at least one of the fluid passageways.