Bodily fluid composition analyzer with disposable cassette

• US 10,568,556 B2
• Filed: 02/05/2018
• Issued: 02/25/2020
• Est. Priority Date: 02/14/2005
• Status: Active Grant

• 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:
  US15/888,918
• Publication Number:
  US 20180168497A1
• Time in Patent Office: 750 Days
• Field of Search: 702 19, 702 22, 702 31, 436180, 422105, 422 81, 422509, 422516, 422521, 13724715, 13762427, 137455, 604131
• 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

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

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

the fluid handling module comprises;

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

at least one control element interface;

a sample analysis chamber configured to intersect an analysis region of the main analysis and control instrument; and

a separator interface configured to engage a fluid component separator, wherein the fluid component separator is configured to separate the bodily fluid into multiple subcomponents;

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

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

separating the sample of the bodily fluid into multiple subcomponents by engaging the fluid component separator at the separator interface;

holding at least one subcomponent in the sample analysis chamber in a non-flowing state with the at least one fluid control element; and

analyzing the at least one subcomponent held in a non-flowing state with a body fluid analyzer to determine the concentration of an analyte.

2. The method of claim 1, further comprising connecting the fluid handling module to the bodily fluid of the patient, wherein the drawing a sample of the bodily fluid from the patient into the fluid handling module comprises withdrawing a sample of the bodily fluid by actuating a syringe pump.

3. The method of claim 1, wherein:

the at least one fluid handling element comprises a syringe;

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

the engaging comprises interfacing the syringe with the syringe drive.

4. The method of claim 1, wherein the fluid handling module comprises a cassette.

5. The method of claim 1, wherein the at least one subcomponent comprises whole blood, plasma or serum.

6. The method of claim 1, wherein the fluid component separator is integrated with the fluid handling module.

7. The method of claim 1, wherein the fluid component separator is a part of the main analysis and control instrument.

8. The method of claim 1, wherein the separator interface comprises a centrifuge rotor configured to engage a centrifuge motor.

9. The method of claim 1, wherein the fluid component separator comprises a membrane.

10. The method of claim 1, wherein the fluid component separator comprises a centrifuge rotor.

11. The method of claim 1, wherein the analyte comprises glucose.

12. The method of claim 1, wherein analyzing the at least one subcomponent comprises performing a spectroscopic analysis of the at least one subcomponent.

13. The method of claim 12, wherein performing the spectroscopic analysis of the at least one subcomponent comprises:

directing infrared radiation from an optical source towards the at least one subcomponent held in the sample analysis chamber; and

receiving infrared radiation transmitted through or reflected from the at least one subcomponent held in the sample analysis chamber at a detector.