FLUID HANDLING CASSETTE SYSTEM FOR BODY FLUID ANALYZER

• US 20180296147A1
• Filed: 01/11/2018
• Published: 10/18/2018
• Est. Priority Date: 10/06/2005
• Status: Active Grant

• 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.
• Granted Patent: US 10,383,561 B2
• Time in Patent Office: Days
• 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

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

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

a frame;

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;

a fluid pressure member configured to engage a pressure member actuator of the main instrument to produce pressure to move the sample of bodily fluid within the fluid handling network;

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

a housing;

one or more fluid passageways supported by the housing; and

at least one sample cell that is accessible via the one or more fluid passageways, wherein the sample cell is configured to interface with a sampling unit of the main instrument for measuring an analyte in at least a portion of the sample of bodily fluid; and

a transfer coupling comprising one or more connectors for removably interconnecting the first cassette module and the second cassette module, wherein the one or more connectors have 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.

22. The fluid handling system of claim 21, wherein the second cassette module comprises a fluid component separator.

23. The fluid handling system of claim 22, wherein the fluid component separator comprises a centrifuge.

24. The fluid handling system of claim 22, wherein the fluid component separator comprises a membrane.

25. The fluid handling system of claim 24, wherein the sample cell interfaces with the sampling unit of the main instrument for electrochemically measuring the analyte in the at least a portion of the sample of bodily fluid.

26. The fluid handling system of claim 22, 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.

27. The fluid handling system of claim 21, wherein the sample cell interfaces with the sampling unit of the main instrument for electrochemically measuring the analyte in the at least a portion of the sample of bodily fluid.

28. The fluid handling system of claim 21, wherein the sample cell interfaces with the sampling unit of the main instrument for optically measuring the analyte in the at least a portion of the sample of bodily fluid.

29. The fluid handling system of claim 21, wherein the housing is removably attachable to the frame.

30. The fluid handling system of claim 21, wherein the housing is separable from the frame such that one of the first cassette module and the second cassette module can be removed from the main instrument while the other of the first cassette module and the second cassette module remains connected to the main instrument.

31. The fluid handling system of claim 21, wherein the housing is movable relative to the frame.

32. The fluid handling system of claim 21, wherein the first cassette module comprises a cleanser fluid source accessible via said fluid handling network.

33. The fluid handling system of claim 21, wherein the first cassette module comprises an anticoagulant fluid source accessible via said fluid handling network.

34. The fluid handling system of claim 21, wherein the first 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.

35. The fluid handling system of claim 34, wherein the first cassette module comprises an infusion fluid pressure member for moving fluid within the infusate passage.

36. The fluid handling system of claim 21, wherein the frame of the first cassette module comprises one or more openings configured to align with one or more valves on the main instrument such that the one or more valves on the main instrument can engage one or more fluid passageways of the fluid handling network.

37. The fluid handling system of claim 21, wherein the frame of the first cassette module comprises one or more openings configured to align with one or more sensors on the main instrument such that the one or more sensors on the main instrument can measure fluid in one or more fluid passageways of the fluid handling network.

38. The fluid handling system of claim 21, wherein the first cassette module comprises a waste receptacle configured to receive at least a portion of the sample of bodily fluid after measurement of the analyte.

39. 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 the fluid handling system of claim 21.

40. A method comprising:

coupling a disposable fluid handling system to a main instrument, wherein the disposable fluid handling system comprises;

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

a frame;

a fluid handling network supported by the frame; and

a fluid pressure member engaged with a pressure member actuator of the main instrument;

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

a housing;

one or more fluid passageways supported by the housing; and

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

a transfer coupling comprising one or more connectors for removably interconnecting the first cassette module and the second cassette module;

actuating the fluid pressure member to draw a sample of bodily fluid from a patient through the fluid handling network;

transferring at least a portion of the sample of bodily fluid through the transfer coupling and through the one or more fluid passageways to the sample cell; and

measuring an analyte in the at least a portion of the sample of bodily fluid in the sample cell.

41. The method of claim 40, comprising transitioning the transfer coupling from an engaged configuration in which the fluid handling network is in fluid communication with the at least one sample cell to a disengaged configuration in which the fluid handling network is not in fluid communication with the at least one sample cell.

42. The method of claim 40, comprising separating at least a portion of the sample of bodily fluid into a plurality of components.

43. The method of claim 42, comprising centrifuging the at least a portion of the sample of bodily fluid.

44. The method of claim 42, comprising passing at least a portion of the sample through a membrane filter.

45. The method of claim 40, comprising electrochemically measuring the analyte in the at least a portion of the sample of bodily fluid.

46. The method of claim 40, comprising optically measuring the analyte in the at least a portion of the sample of bodily fluid.

47. The method of claim 40, comprising transferring the at least a portion of the sample of bodily fluid through the transfer coupling to a waste receptacle of the first cassette module after measuring the analyte.