Fluid handling cassette system for body fluid analyzer

• US 9,883,830 B2
• Filed: 02/03/2017
• Issued: 02/06/2018
• Est. Priority Date: 10/06/2005
• Status: Expired due to Fees

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Keenan, Richard, Chiou, Jeffrey, Gable, Jennifer, Li, Kenneth I-Shen, Tong, Roger, Recknor, Mike, Braig, James R.
• Primary Examiner(s): Sasaki, Shogo
• Application Number:
  US15/424,337
• Publication Number:
  US 20170303839A1
• Time in Patent Office: 368 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150755 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 5/153 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: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G01N 33/50 Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: H05K 999/99 dummy group

Abstract

A fluid handling system for use in bodily fluid analysis. The system comprises a first fluid handling module configured to interface with a main instrument. The first fluid handling module has a first fluid handling network and the first fluid handling network includes an infusate passage and an infusion fluid pressure member suitable for moving fluid within the infusate passage. The fluid handling system also has a second fluid handling module separate from the first module which is configured to interface with the main instrument. The second fluid handling module has a second fluid handling network and at least one sample analysis cell which is accessible via the second fluid handling network. The first and second modules are configured to interconnect and provide fluid communication between the first and second fluid handling network and the sample cells.

Claims

1. A fluid handling system for use in bodily fluid analysis, the system comprising:

a patient cassette module configured to interface with a main instrument, the patient cassette module comprising;

a frame; and

a fluid handling network supported by the frame, the fluid handling network including a patient connection passageway that is configured to draw a sample of bodily fluid from a patient;

an instrument cassette module configured to interface with the main instrument, the instrument cassette module comprising;

a housing;

one or more fluid passageways supported by the housing;

at least one sample cell that is accessible via the one or more fluid passageways; and

a fluid component separator, wherein the fluid component separator is configured to separate at least a portion of the sample into a plurality of components and position one or more of the components in the sample cell for a sensor of the main instrument to measure an analyte in the one or more components; and

a transfer coupling configured to interconnect the instrument cassette module and the patient cassette module to provide fluid communication between the fluid handling network of the patient cassette module and the one or more fluid passageways of the instrument cassette module.

2. The fluid handling system of claim 1, wherein the transfer coupling is configured to removably interconnect the instrument cassette module and the patient cassette module.

3. The fluid handling system of claim 2, wherein the transfer coupling comprises one or more connectors for removably interconnecting the instrument cassette module and the patient cassette module.

4. The fluid handling system of claim 1, wherein the system has an engaged configuration in which the fluid handling network is in fluid communication with the at least one sample cell and a disengaged configuration in which the fluid handling network is not in fluid communication with the at least one sample cell.

5. The fluid handling system of claim 1, wherein the patient cassette module and the instrument cassette module are separately removable from the main instrument.

6. The fluid handling system of claim 1, wherein the housing of the instrument cassette module is removably attachable to the frame of the patient cassette module.

7. The fluid handling system of claim 1, wherein the frame of the patient cassette module comprises one or more openings configured to align with valves and/or sensors on the main instrument such that the valves and/or sensors on the main instrument can engage fluid passageways of the fluid handling network.

8. The fluid handling system of claim 1, wherein the frame of the patient cassette module comprises one or more openings configured to align with one or more syringe pump actuators on the main instrument such that the one or more syringe pump actuators can engage one or more syringe pump bodies on the patient cassette module.

9. The fluid handling system of claim 1, wherein the patient cassette module comprises an anticoagulant fluid source accessible via said fluid handling network.

10. The fluid handling system of claim 9, wherein the patient cassette module comprises an anticoagulant fluid pressure member suitable for moving fluid from said anticoagulant fluid source.

11. The fluid handling system of claim 1, wherein the patient cassette module comprises a waste reservoir configured to receive at least a portion of the sample of bodily fluid after measurement of the analyte.

12. The fluid handling system of claim 1, wherein the patient cassette module comprises one or more pumps to move fluid within the fluid handling network.

13. The fluid handling system of claim 1, wherein the patient cassette module comprises an air passageway configured to form an injector for injecting air bubbles into fluid in the fluid handling network.

14. The fluid handling system of claim 1, wherein the patient cassette module further comprises a cleanser fluid source accessible via the fluid handling network.

15. The fluid handling system of claim 14, wherein the patient cassette module comprises a cleanser fluid pressure member configured to move fluid from the cleanser fluid source through the fluid handling network.

16. The fluid handling system of claim 1, wherein the fluid component separator comprises a centrifuge.

17. The fluid handling system of claim 1, wherein the fluid component separator comprises a filter.

18. The fluid handling system of claim 1, wherein the patient cassette module comprises an infusate passage configured to couple to an infusate reservoir, wherein the patient connection passageway is configured to deliver fluid from the infusate reservoir to the patient.

19. A body fluid analysis system comprising:

the fluid handling system of claim 1; and

the main instrument comprising the sensor measuring the analyte in the one or more components, the main instrument interfacing with the patient cassette module and the instrument cassette module of the fluid handling system.

20. A method comprising:

removing a used disposable fluid handling system from a main instrument; and

coupling a replacement disposable fluid handling system to the main instrument;

wherein the replacement disposable fluid handling system comprises;

a patient cassette module configured to interface with the main instrument, the patient cassette module comprising;

a frame; and

a fluid handling network supported by the frame, the fluid handling network including a patient connection passageway that is configured to draw a sample of bodily fluid from a patient;

an instrument cassette module configured to interface with the main instrument, the instrument cassette module comprising;

a housing;

one or more fluid passageways supported by the housing;

at least one sample cell that is accessible via the one or more fluid passageways; and

a fluid component separator, wherein the fluid component separator is configured to separate at least a portion of the sample into a plurality of components and position one or more of the components in the sample cell for a sensor of the main instrument to measure an analyte in the one or more components; and

a transfer coupling configured to interconnect the instrument cassette module and the patient cassette module to provide fluid communication between the fluid handling network of the patient cassette module and the one or more fluid passageways of the instrument cassette module.