FLUID HANDLING CASSETTE SYSTEM FOR BODY FLUID ANALYZER

• US 20070104616A1
• Filed: 10/06/2006
• Published: 05/10/2007
• Est. Priority Date: 10/06/2005
• Status: Abandoned Application

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Keenan, Richard, Braig, James, Recknor, Mike, Tong, Roger, Li, Ken, Gable, Jennifer, Chion, Jeff
• Application Number:
  US11/539,534
• Publication Number:
  US 20070104616A1
• Time in Patent Office: Days
• US Class Current: 422/100
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• 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 5/150755 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 5/153 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 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14212 Pumping with an aspiration and an expulsion action
• 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: B01L 13/00 Cleaning or rinsing apparatus
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2300/0803 Disc shape
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0887 : Laminated structure
• CPC Class Codes: B01L 2400/0406 : capillary forces
• CPC Class Codes: B01L 2400/0409 : centrifugal forces
• CPC Class Codes: B01L 2400/0487 : fluid pressure, pneumatics
• CPC Class Codes: B01L 3/5027 : by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: G01N 35/1097 : characterised by the valves valves in general F16K

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, said system comprising:

a first fluid handling module configured to interface with a main instrument, said first fluid handling module having;

a first fluid handling network, said first fluid handling network including an infusate passage; and

an infusion fluid pressure member suitable for moving fluid within said infusate passage; and

a second fluid handling module separate from said first module and configured to interface with said main instrument, said second fluid handling module having at least one sample analysis cell;

wherein said first and second modules are configured to interconnect and provide fluid communication between said first fluid handling network and said sample cell.

2. The system of claim 1, wherein said second fluid handling module further comprises a second fluid handling network, and said sample analysis cell is accessible via said second fluid handling network.

3. The system of claim 2, wherein said second fluid handling module further comprises a fluid component separator accessible via said second fluid handling network.

4. The system of claim 3, wherein said fluid component separator comprises a centrifuge rotor.

5. The system of claim 3, wherein said fluid component separator comprises a filter.

6. The system of claim 1, wherein said infusion fluid pressure member comprises a pump.

7. The system of claim 1, wherein said infusion fluid pressure member comprises a syringe pump body.

8. The system of claim 1, wherein said infusion fluid pressure member comprises a portion of said first fluid handling network which is configured to engage a roller pump actuator.

9. The system of claim 8, wherein said infusion fluid pressure member comprises a fluid passage which extends across an opening which facilitates engagement of said passage with said roller pump actuator.

10. The system of claim 1, wherein said first fluid handling module further comprises a cleanser fluid source accessible via said first fluid handling network.

11. The system of claim 10, wherein said first fluid handling module further comprises a cleanser fluid pressure member suitable for moving fluid from said cleanser fluid source.

12. The system of claim 1, wherein said first fluid handling module further comprises an anticoagulant fluid source accessible via said first fluid handling network.

13. The system of claim 12, wherein said first fluid handling module further comprises an anticoagulant fluid pressure member suitable for moving fluid from said anticoagulant fluid source.

14. The system of claim 2, wherein said first and second modules are interconnected and said first and second fluid handling networks are in fluid communication.

15. A body fluid analysis system comprising:

a body fluid analysis instrument;

a first fluid handling module comprising a first housing and a first fluid handling network, said first fluid handling module being removably connected to said instrument such that said first housing engages said instrument;

a second fluid handling module comprising a second housing separate from said first housing, and a sample analysis cell;

said second fluid handling module being removably connected to said instrument such that said second housing engages said instrument;

wherein said first and second fluid handling modules are connected to each other and said first and second fluid handling modules are in fluid communication with each other.

16. The system of claim 15, wherein said second fluid handling module further comprises a second fluid handling network, and said sample analysis cell is accessible via said second fluid handling network.

17. The system of claim 16, wherein said second fluid handling module further comprises a fluid component separator accessible via said second fluid handling network.

18. The system of claim 17, wherein said fluid component separator comprises a centrifuge rotor.

19. The system of claim 17, wherein said fluid component separator comprises a filter.

20. The system of claim 15, further comprising at least one pump at least partially formed by said first fluid handling module, said pump configured to move fluid in said first fluid handling network.

21. The system of claim 20, wherein said pump comprises at least one of an infusion pump, a cleanser pump, and an anticoagulant pump.

22. The system of claim 20, wherein said pump comprises at least one of a syringe pump and a roller pump.

23. The system of claim 15, wherein said first fluid handling module further comprises at least one of a cleanser fluid source and an anticoagulant fluid source.

24. The system of claim 15, wherein said first module and said second module are connected together by a transfer coupling that includes parts of a sampling passageway and a cleanser passageway.

25. A method of using a bodily fluid analysis system having a main instrument and first and second replaceable fluid handling modules removably connected to said main instrument, said analysis system having a pump at least partially formed by said first fluid handling module, and a sample analysis chamber in said second fluid handling module, said method comprising:

replacing said first fluid handling module at a first replacement frequency;

replacing said second fluid handling module at a second replacement frequency;

wherein said first replacement frequency differs from said second replacement frequency.

26. The method of claim 25, wherein said first replacement frequency is higher than said second replacement frequency.

27. The method of claim 25, wherein replacing said first fluid handling module comprises replacing said first module each time a new patient is associated with said analysis system.

28. The method of claim 25, wherein replacing said first fluid handling module comprises replacing said first module after a specified number of measurements have been made with said first module.

29. The method of claim 25, wherein replacing said first fluid handling module comprises replacing said first module after a specified time has elapsed since said first module was placed in service.

30. The method of claim 25, wherein replacing said first fluid handling module comprises replacing at least a portion of said pump.

31. The method of claim 30, wherein replacing at least a portion of a pump comprises replacing a syringe pump body.

32. The method of claim 30, wherein replacing at least a portion of a pump comprises replacing a portion of a fluid passageway which is configured to engage a roller pump actuator.

33. A method of handling a bodily fluid, said method comprising;

drawing a volume of said bodily fluid from a patient into a fluid handling network;

retaining a sample of said drawn volume in said fluid handling network, said retained sample comprising less than half of said drawn volume;

returning the balance of said drawn volume to said patient in less than five minutes after said drawing was commenced; and

analyzing at least a portion of said sample.

34. The method of claim 33, further comprising disposing of said sample after said analyzing.

35. The method of claim 33, further comprising moving said sample to a waste container.

36. The method of claim 33, further comprising:

infusing a liquid into said patient via said fluid handling network; and

occasionally interrupting said infusing to facilitate said drawing.

37. The method of claim 33, wherein returning the balance of said drawn volume to said patient comprises returning the balance in less than four minutes after said drawing was commenced.

38. The method of claim 33, wherein returning the balance of said drawn volume to said patient comprises returning the balance in less than three minutes after said drawing was commenced.

39. The method of claim 33, wherein returning the balance of said drawn volume to said patient comprises returning the balance in less than two minutes after said drawing was commenced.

40. The method of claim 33, wherein returning the balance of said drawn volume to said patient comprises returning the balance between two minutes and five minutes after said drawing was commenced.

41. The method of claim 33, wherein said drawn volume is less than 5 milliliters.

42. The method of claim 33, wherein said drawn volume is less than 400 microliters.

43. The method of claim 33, wherein said drawn volume is between 400 microliters and 5 milliliters.

44. The method of claim 33, wherein said sample is less than 100 microliters in volume.

45. The method of claim 33, wherein said sample is between 20 microliters and 100 microliters in volume.

46. The method of claim 33, wherein said analyzing comprises spectroscopically analyzing.

47. The method of claim 33, further comprising separating a component of said sample, and said analyzing comprises analyzing only said component.

48. A method of handling a bodily fluid, said method comprising;

drawing a volume of said bodily fluid from a patient into a fluid handling network;

retaining a sample of said drawn volume in said fluid handling network, said retained sample comprising less than half of said drawn volume;

returning the balance of said drawn volume to said patient; and

analyzing at least a portion of said sample;

wherein said analyzing takes at least 10 seconds to complete.

49. The method of claim 48, wherein said analyzing comprises spectroscopically analyzing, and said analyzing commences upon first emitting a beam of electromagnetic radiation into at least a portion of said sample.

50. The method of claim 49, wherein said analyzing is complete upon completion of said emitting.

51. The method of claim 48, wherein said analyzing takes at least thirty seconds to complete.

52. The method of claim 48, wherein said analyzing takes at least one minute to complete.

53. The method of claim 48, wherein said analyzing takes at least two minutes to complete.

54. The method of claim 48, wherein said analyzing takes at least three minutes to complete.

55. The method of claim 48, wherein said analyzing takes at least five minutes to complete.

56. The method of claim 48, wherein said analyzing takes between 10 seconds and five minutes to complete.

57. The method of claim 48, further comprising:

infusing a liquid into said patient via said fluid handling network; and

occasionally interrupting said infusing to facilitate said drawing.

58. The method of claim 48, further comprising separating a component of said sample, and said analyzing comprises analyzing only said component.

59. A bodily fluid analyzer comprising:

a fluid handling network configured for fluid communication with a bodily fluid within a patient;

an analyte detection system configured to examine a sample of bodily fluid in said fluid handling network;

said analyzer further comprising a processor and stored program instructions executable by said processor so that said analyzer is operable to;

draw a volume of said bodily fluid into said fluid handling network;

retain a sample of said drawn volume in said fluid handling network, said retained sample comprising less than half of said drawn volume;

return the balance of said drawn volume to said patient in less than five minutes after said drawing was commenced; and

analyze at least a portion of said sample.

60. The analyzer of claim 59, wherein said analyzer is further operable to move said sample to a waste container after analyzing said sample.

61. The analyzer of claim 59, wherein said fluid handling network is in communication with an infusion liquid source and said analyzer is further operable to infuse said liquid via said fluid handling network.

62. The analyzer of claim 61, wherein said analyzer is further operable to occasionally interrupt infusing said liquid to draw said volume.

63. The analyzer of claim 59, wherein said analyzer is further operable to return the balance of said drawn volume to said patient in less than four minutes after said analyzer has commenced drawing said volume.

64. The analyzer of claim 59, wherein said analyzer is further operable to return the balance of said drawn volume to said patient in less than three minutes after said analyzer has commenced drawing said volume.

65. The analyzer of claim 59, wherein said analyzer is further operable to return the balance of said drawn volume to said patient in less than two minutes after said analyzer has commenced drawing said volume.

66. The analyzer of claim 59, wherein said analyzer is further operable to return the balance of said drawn volume to said patient between two and five minutes after said analyzer has commenced drawing said volume.

67. The analyzer of claim 59, wherein said drawn volume is less than 5 milliliters.

68. The analyzer of claim 59, wherein said drawn volume is less than 400 microliters.

69. The analyzer of claim 59, wherein said drawn volume is between 400 microliters and 5 milliliters.

70. The analyzer of claim 59, wherein said sample is less than 100 microliters in volume.

71. The analyzer of claim 59, wherein said sample is between 20 microliters and 100 microliters in volume.

72. The analyzer of claim 59, wherein said analyte detection system comprises a spectroscopic analyte detection system.

73. The analyzer of claim 59, further comprising a fluid component separator accessible via said fluid handling network

74. A bodily fluid analyzer comprising:

a fluid handling network configured for fluid communication with a bodily fluid within a patient;

an analyte detection system configured to examine a sample of bodily fluid in said fluid handling network;

said analyzer further comprising a processor and stored program instructions executable by said processor so that said analyzer is operable to;

draw a volume of said bodily fluid from a patient into a fluid handling network;

retain a sample of said drawn volume in said fluid handling network, said retained sample comprising less than half of said drawn volume;

return the balance of said drawn volume to said patient; and

analyze at least a portion of said sample;

wherein said analyzing takes at least 10 seconds to complete.

75. The analyzer of claim 74, wherein said analyte detection system comprises a spectroscopic analyte detection system, and wherein said analyzing commences upon first emitting a beam of electromagnetic radiation into at least a portion of said sample.

76. The analyzer of claim 75, wherein said analyzing is complete upon completion of said emitting.

77. The analyzer of claim 74, wherein said analyzing takes at least two minutes to complete.

78. The analyzer of claim 74, wherein said analyzing takes at least three minutes to complete.

79. The analyzer of claim 74, wherein said analyzing takes at least five minutes to complete.

80. The analyzer of claim 74, wherein said analyzing takes between 10 seconds and five minutes to complete.

81. The analyzer of claim 74, wherein said fluid handling network is in communication with an infusion liquid source and said analyzer is further operable to infuse said liquid via said fluid handling network.

82. The analyzer of claim 81, wherein said analyzer is further operable to occasionally interrupt said infusing of said liquid to draw said volume.

83. The analyzer of claim 74, further comprising a fluid component separator accessible via said fluid handling network.