Blood parameter testing system

• US 20070129618A1
• Filed: 06/20/2005
• Published: 06/07/2007
• Est. Priority Date: 06/20/2005
• Status: Abandoned Application

• Current Assignee: IntelliDx, Inc.
• Original Assignee: IntelliDx, Inc.
• Inventors: Siebrecht, Wayne, Nagar, Ron, Shreve, Eric, Bitton, Gabby, Pesach, Gidi, Goldberger, Daniel, Pesach, Benny
• Application Number:
  US11/157,110
• Publication Number:
  US 20070129618A1
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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 5/6866 Extracorporeal blood circuits, e.g. dialysis circuits

Abstract

A substantially automatic blood parameter testing apparatus for obtaining a blood sample and determining the concentration of at least one analyte is connected to a venous or arterial access line and further comprises a pump fixedly attached to a tube originating from the vascular access point; a valve fixedly attached to the tube and located above the pump mechanism; at least one measurement element; a needleless port; and an electronic meter. In addition, the automated blood parameter testing apparatus may be integrated into a complete system, further including a monitor and a central monitoring station.

Claims

1. A device for substantially automatically obtaining a blood sample and determining the concentration of at least one analyte comprising:

a vascular access point;

a tube originating from the vascular access point;

a pump fixedly attached to the tube;

a valve fixedly attached to the tube and located above the pump mechanism;

at least one measurement element;

a needleless port; and

an electronic meter.

2. The device of claim 1 further comprising at least one capillary transport structure.

3. The device of claim 2 wherein the at least one capillary transport structure is adapted to connect to the needle-less port.

4. The device of claim 1 wherein the pump is a syringe, further comprising a plunger and a reservoir.

5. The device of claim 1 wherein the electronic meter is a blood glucose monitor.

6. The device of claim 1 wherein blood contacting elements are disposable.

7. The device of claim 6 wherein blood contacting elements are contained in a disposable cartridge or cassette.

8. The device of claim 6 wherein the disposable elements are mechanically, electrically or otherwise keyed to mate with reusable elements.

9. The device of claim 1 wherein the chemistry is mechanically isolated from the blood circuit.

10. The device of claim 1 wherein the measurement element is a glucose oxidase test strip.

11. The device of claim 1 wherein the measurement element is a sensor.

12. The device of claim 11 wherein the sensor is contained in a sensor cassette.

13. The device of claim 12 wherein the sensor cassette is disposable.

14. The device of claim 12 wherein the sensor cassette comprises at least one pre-calibrated single use sensor.

15. The device of claim 12 wherein the sensor cassette comprises a plurality of sensors arranged in a multiple layer tape structure.

16. The device of claim 14 wherein each single-use sensor is advanced sequentially and positioned for direct contact with a blood sample through an advancement means.

17. The device of claim 11 wherein the sensor cassette includes a plurality of sensor cassettes, each comprising a different type of sensor.

18. The device of claim 11 wherein the sensor is an electrochemical sensor capable of detecting the presence of and enabling the measurement of the level of an analyte in a blood sample via electrochemical oxidation and reduction reactions at the sensor.

19. The device of claim 11 wherein the sensor is an optochemical sensor capable of detecting the presence of and enabling the measurement of the level of an analyte in a blood or plasma.

20. The device of claim 11 wherein the sensor determines the oxygenation level of the blood and uses the oxygenation level to calibrate the glucose calculation.

21. The device of claim 11 wherein the sensor determines the hemoglobin concentration and/or hematocrit of the blood and calibrates the glucose calculation.

22. The device of claim 1 wherein the needleless port is used to hold the sample of blood for glucose measurement.

23. The device of claim 1 wherein the blood sample is obtained at predetermined, programmable time intervals or operator indication.

24. The device of claim 23 wherein the operator indication is via a push button.

25. A device for substantially automatically obtaining a blood sample and determining the concentration of at least one analyte comprising:

a vascular access point;

a tube originating from the vascular access point;

a pump mechanism fixedly attached to the tube;

a valve fixedly attached to the tube such that said pump lies between said valve and the vascular access point;

at least one measurement element;

at least one capillary transport structure;

a needleless port; and

an electronic meter.

26. The device of claim 25 wherein the at least one capillary transport structure is adapted to connect to the needleless port.

27. The device of claim 25 wherein the pump is a syringe, further comprising a plunger and a reservoir.

28. The device of claim 25 wherein the electronic meter is a blood glucose monitor.

29. The device of claim 25 wherein blood contacting elements are disposable.

30. The device of claim 29 wherein blood contacting elements are contained in a disposable cartridge or cassette.

31. The device of claim 29 wherein the disposable elements are mechanically, electrically or otherwise keyed to mate with reusable elements.

32. The device of claim 25 wherein the chemistry is mechanically isolated from the blood circuit.

33. The device of claim 25 wherein the measurement element is a glucose oxidase test strip.

34. The device of claim 25 wherein the measurement element is a sensor.

35. The device of claim 34 wherein the sensor is contained in a sensor cassette.

36. The device of claim 35 wherein the sensor cassette is disposable.

37. The device of claim 35 wherein the sensor cassette comprises at least one pre-calibrated single use sensor.

38. The device of claim 35 wherein the sensor cassette comprises a plurality of sensors arranged in a multiple layer tape structure.

39. The device of claim 37 wherein each single-use sensor is advanced sequentially and positioned for direct contact with a blood sample through an advancement means.

40. The device of claim 35 wherein the sensor cassette includes a plurality of sensor cassettes, each comprising a different type of sensor.

41. The device of claim 35 wherein the sensor is an electrochemical sensor capable of detecting the presence of and enabling the measurement of the level of an analyte in a blood sample via electrochemical oxidation and reduction reactions at the sensor.

42. The device of claim 35 wherein the sensor is an optochemical sensor capable of detecting the presence of and enabling the measurement of the level of an analyte in a blood or plasma sample via optochemical oxidation and reduction reactions at the sensor.

43. The device of claim 35 wherein the sensor determines the oxygenation level of the blood and uses the oxygenation level to calibrate the glucose calculation.

44. The device of claim 35 wherein the sensor determines the hemoglobin concentration and/or hematocrit of the blood and calibrates the glucose calculation.

45. The device of claim 25 wherein the needle-less port is used to hold the sample of blood for glucose measurement.

46. The device of claim 25 wherein the blood sample is obtained at predetermined, programmable time intervals or operator indication.

47. The device of claim 47 wherein the operator indication is via a push button.

48. A method for substantially automatically obtaining a blood sample and determining the concentration of at least one analyte comprising:

creating a vascular access point in association with a patient'"'"'s blood vessel;

attaching a tube to said vascular access point;

closing a valve fixedly attached to the tube in response to a blood sample indication;

creating suction in the tube by activating a pump fixedly attached to the tube, with fluid contained in the tubing;

withdrawing blood from the vascular access point of the patient;

extending a capillary transport structure into a needleless port and filling said capillary transport with the blood withdrawn from the vascular access point of the patient;

delivering the withdrawn blood to a measurement element, fixedly connected to the capillary transport structure; and

calculating a blood parameter of the sample using an electronic meter.

49. The method of claim 48 wherein the at least one capillary transport structure is adapted to connect to the needleless port.

50. The method of claim 48 wherein the pump is a syringe, further comprising a plunger and a reservoir.

51. The method of claim 48 wherein the electronic meter is a blood glucose monitor.

52. The method of claim 48 wherein blood contacting elements are disposable.

53. The method of claim 52 wherein blood contacting elements are contained in a disposable cartridge or cassette.

54. The method of claim 52 wherein the disposable elements are mechanically, electrically or otherwise keyed to mate with reusable elements.

55. The method of claim 48 wherein the chemistry is mechanically isolated from the blood circuit.

56. The method of claim 48 wherein the measurement element is a glucose oxidase test strip.

57. The method of claim 48 wherein the measurement element is a sensor.

58. The method of claim 57 wherein the sensor is contained in a sensor cassette.

59. The method of claim 58 wherein the sensor cassette is disposable.

60. The method of claim 58 wherein the sensor cassette comprises at least one pre-calibrated single use sensor.

61. The method of claim 58 wherein the sensor cassette comprises a plurality of sensors arranged in a multiple layer tape structure.

62. The method of claim 60 wherein each single-use sensor is advanced sequentially and positioned for direct contact with a blood sample through an advancement means.

63. The method of claim 58 wherein the sensor cassette includes a plurality of sensor cassettes, each comprising a different type of sensor.

64. The method of claim 57 wherein the sensor is an electrochemical sensor capable of detecting the presence of and enabling the measurement of the level of an analyte in a blood sample via electrochemical oxidation and reduction reactions at the sensor.

65. The method of claim 57 wherein the sensor is an optochemical sensor capable of detecting the presence of and enabling the measurement of the level of an analyte in a blood or plasma sample.

66. The method of claim 57 wherein the sensor determines the oxygenation level of the blood and uses the oxygenation level to calibrate the glucose calculation.

67. The method of claim 57 wherein the sensor determines the hemoglobin concentration and/or hematocrit of the blood and calibrates the glucose calculation.

68. The method of claim 48 wherein the needleless port is used to hold the sample of blood for glucose measurement.

69. The method of claim 48 wherein the blood sample is obtained at predetermined, programmable time intervals or operator indication.

70. The method of claim 69 wherein the operator indication is via a push button.

71. A device for substantially automatically obtaining a blood sample and determining the concentration of at least one analyte comprising:

a vascular access point;

a tube originating from the vascular access point;

a pump fixedly attached to the tube;

a first valve fixedly attached to the tube such that said pump lies between the first valve and vascular access point;

a second valve fixedly attached to said tube such that said second valve lies between the pump and the vascular access point, wherein said second valve isolates the pump from vascular pressure;

at least one measurement element;

at least one capillary transport structure;

a needleless port; and

an electronic meter.

72. A method for substantially automatically obtaining a blood sample and determining the concentration of at least one analyte comprising:

connecting a vascular access point of a patient to a tube;

closing a first valve fixedly attached to the tube and located above the pump in response to a blood sample indication;

creating suction in the tube by energizing a pump fixedly attached to the tube;

withdrawing blood from the vascular access point of the patient;

closing a second valve fixedly attached to the tube and located below the pump, wherein the second valve is used to isolate the reservoir from vascular pressure;

extending a capillary transport member into a needleless port and filling said capillary transport with the blood withdrawn from the vascular access point of the patient;

delivering the withdrawn blood to a measurement element, fixedly connected to said capillary transport structure; and

calculating a blood parameter of the sample using an electronic meter.

73. A device for substantially automatically obtaining a blood sample and determining the concentration of at least one analyte comprising:

a tube terminating at a vascular access point;

a pump fixedly attached to the tube;

a valve fixedly attached to the tube and located above the pump;

at least one measurement element;

at least one capillary transport structure;

a needleless port;

an electronic meter; and

a sensor.

74. The device of claim 73 wherein said sensor is used for determining the presence of blood in the tube for analysis.

75. The device of claim 73 wherein said sensor is used for determining the presence of undiluted blood in the tube for analysis.

76. The device of claim 73 wherein said sensor is used for verifying that no bubbles are present in the fluid contained in the tube.

77. The device of claim 73 wherein the sensor determines the oxygenation level of the blood and uses the oxygenation level to calibrate the glucose calculation.

78. The device of claim 73 wherein the sensor determines the hemoglobin concentration and/or hematocrit of the blood and calibrates the glucose calculation.

79. A method for substantially automatically obtaining a blood sample and determining the concentration of at least one analyte comprising:

connecting a vascular access point of a patient to a tube;

closing a valve fixedly attached to the tube and located above the pump in response to a blood sample indication;

creating suction in the tube by energizing a pump fixedly attached to the tube;

withdrawing blood from the vascular access point of the patient;

determining the presence of a blood sample via a blood sensor;

extending a capillary transport member into a needle-less port and filling said capillary transport with the blood withdrawn from the vascular access point of the patient;

delivering the withdrawn blood to a measurement element, fixedly connected to the capillary transport structure; and

calculating a blood parameter of the sample using an electronic meter.

80. A device for substantially automatically obtaining a blood sample and determining the concentration of at least one analyte comprising:

a tube originating from a vascular access point;

a pump fixedly attached to the tube;

a first valve fixedly attached to the tube and located above the pump;

a second valve fixedly attached to the tube and located below the pump;

at least one measurement element;

at least one capillary transport structure;

a needle-less port;

an electronic meter; and

a blood sensor.

81. A method for substantially automatically obtaining a blood sample and determining the concentration of at least one analyte comprising:

connecting a vascular access point of a patient to a tube;

closing a first valve fixedly attached to the tube and located above the pump in response to a blood sample indication;

creating suction in the tube by activating a pump fixedly attached to the tube;

withdrawing blood from the vascular access point of the patient;

determining the presence of a blood sample via a blood sensor;

closing a second valve fixedly attached to the tube and located below the pump;

extending a capillary transport member into a needle-less port and filling said capillary transport with the blood withdrawn from the vascular access point of the patient;

delivering the withdrawn blood to a measurement element, fixedly connected to said capillary transport structure; and

calculating a blood parameter of the sample using an electronic meter.

82. A system for substantially automatically obtaining a blood sample and determining the concentration of at least one analyte comprising:

a monitor;

a central monitoring station; and

a blood parameter testing apparatus, further comprising;

a vascular access point;

a tube originating from the vascular access point;

a pump fixedly attached to the tube;

a valve fixedly attached to the tube and located above the pump mechanism;

at least one measurement element;

a needleless port; and

an electronic meter.

83. The system of claim 82 wherein the blood parameter testing apparatus further comprises at least one capillary transport structure.

84. The system of claim 82 wherein the blood parameter testing device is a blood glucose monitor.

85. The system of claim 82 wherein the blood parameter testing device is in automatic operation.

86. The system of claim 82 wherein the automatic blood parameter testing device is programmable to initiate a periodic sample reading.

87. The system of claim 82 wherein a periodic sample reading is initiated via operator input.

88. The system of claim 82 wherein data is transmitted between the blood parameter testing device and a monitor.

89. The system of claim 82 wherein said monitor maintains a record of at least one automated blood parameter testing device, at least one monitor, at least one patient, and at least one set of physiological parameters.

90. The system of claim 82 wherein measurement results are stored for trending or later download.

91. The system of claim 82 wherein the system alerts based on predefined levels or ranges for blood parameters.

92. A system for substantially automatically obtaining a blood sample and determining the concentration of at least one analyte comprising:

a monitor;

a central monitoring station; and

a blood parameter testing apparatus, further comprising;

a tube originating from a vascular access point;

a pump mechanism fixedly attached to the tube;

a valve fixedly attached to the tube and located above the pump mechanism;

at least one measurement element;

at least one capillary transport structure;

a needleless port; and

an electronic meter.

93. The system of claim 92 wherein the blood parameter testing device is a blood glucose monitor.

94. The system of claim 92 wherein the blood parameter testing device is in automatic operation.

95. The system of claim 92 wherein the automatic blood parameter testing device is programmable to initiate a periodic sample reading.

96. The system of claim 92 wherein a periodic sample reading is initiated via operator input.

97. The system of claim 92 wherein data is transmitted between the blood parameter testing device and a monitor.

98. The system of claim 92 wherein data is transmitted between a monitor and a central monitoring station.

99. The system of claim 92 wherein said central monitoring station maintains a record of at least one automated blood parameter testing device, at least one monitor, at least one patient, and at least one set of physiological parameters.

100. The system of claim 92 wherein measurement results are stored for trending or later download.

101. The system of claim 92 wherein the system alerts based on predefined levels or ranges for blood parameters.

102. A system for substantially automatically obtaining a blood sample and determining the concentration of at least one analyte comprising:

a monitor;

a central monitoring station; and

a blood parameter testing apparatus, further comprising;

a vascular access point;

a tube originating from the vascular access point;

a pump fixedly attached to the tube;

a first valve fixedly attached to the tube and located above the pump;

a second valve fixedly attached to said tube and located below the pump, wherein said second valve isolates the pump from vascular pressure;

at least one measurement element;

at least one capillary transport structure;

a needleless port; and

an electronic meter.

103. A system for substantially automatically obtaining a blood sample and determining the concentration of at least one analyte comprising:

a monitor;

a central monitoring station; and

a blood parameter testing apparatus, further comprising;

a tube terminating at a vascular access point;

a pump fixedly attached to the tube;

a valve fixedly attached to the tube and located above the pump;

at least one measurement element;

at least one capillary transport structure;

a needleless port;

an electronic meter; and

a sensor.

104. A system for substantially automatically obtaining a blood sample and determining the concentration of at least one analyte comprising:

a monitor;

a central monitoring station; and

a blood parameter testing apparatus, further comprising;

a tube originating from the vascular access point;

a pump fixedly attached to the tube;

a first valve fixedly attached to the tube and located above the pump;

a second valve fixedly attached to the tube and located below the pump;

at least one measurement element;

at least one capillary transport structure;

a needle-less port;

an electronic meter; and

a blood sensor.