Apparatus and methods for analyzing body fluid samples

• US 20070060872A1
• Filed: 02/13/2006
• Published: 03/15/2007
• Est. Priority Date: 02/14/2005
• Status: Abandoned Application

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Wechsler, Mark, Keenan, Richard, Rule, Peter, Braig, James, Gable, Jennifer, Callicoat, David, Witte, Kenneth, Hall, W.
• Application Number:
  US11/352,956
• Publication Number:
  US 20070060872A1
• Time in Patent Office: Days
• US Class Current: 604/66
• 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 5/150213 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 5/150358 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: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 5/14212 Pumping with an aspiration and an expulsion action

Abstract

An apparatus is provided for monitoring a predetermined parameter of a patient'"'"'s body fluid while infusing an infusion fluid into the patient. The apparatus comprises an infusion line and a catheter configured for insertion into a blood vessel of the patient, and a reversible infusion pump connected between a source of an infusion fluid and the infusion line and catheter. The apparatus further comprises a body fluid sensor assembly mounted in fluid communication with the infusion line and which includes a first sensor and a sample cell. The first sensor provides a signal indicative of a predetermined parameter of any fluid present in the infusion line. The sample cell is substantially transmissive to light comprising a wavelength λ. The apparatus further comprises a controller that is configured to operate the infusion pump in a forward direction so as to pump the infusion fluid through the infusion line and catheter for infusion into the patient. The controller is configured to intermittently interrupt its operating of the infusion pump in the forward direction to operate the infusion pump in a rearward direction so as to draw a body fluid sample from the patient through the catheter and infusion line. The body fluid sample drawn from the patient is disposed such that a first portion of the body fluid sample is in sensing contact with the first sensor of the body fluid sensor assembly, and a second portion of the body fluid sample is disposed within the sample cell of the body fluid sensor assembly. The controller further is configured to monitor the signal provided by the first sensor of the body fluid sensor assembly and to detect a change in the signal indicative of the arrival of the body fluid sample at the first sensor. The controller, in response to detecting the arrival of the body fluid sample at the first sensor, is configured to cease its operating of the infusion pump in the rearward direction. The signal produced by the first sensor provides an indication of a predetermined parameter of the patient'"'"'s body fluid when the body fluid sample is in sensing contact with the first sensor.

Claims

1. Apparatus for monitoring a predetermined parameter of a patient'"'"'s body fluid and infusing the patient, comprising:

an infusion line having a patient end configured for fluid communication with a blood vessel of the patient;

a source of an infusion fluid, said source in fluid communication with said infusion line;

a reversible infusion pump coupled to the infusion line;

a body fluid sensor assembly mounted in fluid communication with the infusion line and including a first sensor, said first sensor comprising an optical sensor configured to provide a signal indicative of a predetermined parameter of fluid present in the infusion line near said first sensor; and

a controller that is configured to operate the infusion pump in a forward direction, to pump the infusion fluid through the infusion line toward the patient end, and that is configured to intermittently interrupt its operation of the infusion pump in the forward direction to operate the infusion pump in a rearward direction, to draw a body fluid sample from the patient through the patient end of the infusion line.

2. The apparatus of claim 1, wherein said optical sensor comprises a sample cell that is substantially transmissive to light comprising a wavelength λ

.

3. The apparatus of claim 2, wherein said sample cell comprises one or more windows that are substantially transmissive to light comprising the wavelength λ

.

4. The apparatus of claim 2 further comprising:

a light source configured to produce light comprising the wavelength λ

;

a light detector configured to be responsive to light comprising the wavelength λ

;

an optical path defined from the light source to the sample cell and from the sample cell to the light detector;

wherein the light source, the light detector, and the sample cell are configured to be in optical communication along the optical path.

5. The apparatus of claim 4, wherein the optical path comprises one or more optical fibers.

6. The apparatus of claim 2, wherein the wavelength λ

is in the infrared.

7. The apparatus of claim 2, wherein the wavelength λ

is in the range from 1 micron to 20 microns.

8. The apparatus of claim 2, wherein the wavelength λ

is in the range from 4 microns to 10 microns.

9. The apparatus of claim 4, wherein the light detector is a spectrometer.

10. The apparatus of claim 4, wherein light comprising the wavelength λ

is directed from the light source to the sample cell along the optical path such that the light interacts with a portion of the body fluid sample in the sample cell and a portion of the light is directed to the light detector along the optical path.

11. The apparatus of claim 10, wherein the light is transmitted through the portion of the body fluid sample in the sample cell.

12. The apparatus of claim 10, wherein the light is reflected from the portion of the body fluid sample in the sample cell.

13. The apparatus of claim 1, wherein the controller is configured to monitor the signal provided by the first sensor of the body fluid sensor assembly and to detect a change in the signal indicative of an arrival of the body fluid sample at the first sensor.

14. The apparatus of claim 13, wherein the controller is configured to cease its operating of the infusion pump in the rearward direction in response to detecting the arrival of the body fluid sample at the first sensor.

15. A method of extracting and analyzing bodily fluids from a patient at the point of care for said patient comprising:

establishing fluid communication between an analyte detection system, a sensor assembly, and a bodily fluid in said patient, wherein said sensor assembly comprises a first sensor;

drawing from said patient a portion of said bodily fluid;

separating from said drawn portion a first component of said bodily fluid, while said analyte detection system and said sensor assembly remain in fluid communication with said patient; and

with said analyte detection system, analyzing said first component to measure a concentration of an analyte.

16. The method of claim 15, wherein said first sensor comprises an optical sensor.

17. The method of claim 15, wherein said separating comprises filtering said first component from said drawn portion of bodily fluid.

18. The method of claim 15, wherein said separating comprises centrifuging said first component from said drawn portion of bodily fluid.

19. The method of claim 15, said method further comprising:

monitoring a signal produced by said first sensor of the sensor assembly; and

detecting a change in said signal indicative of an arrival of said bodily fluid at said first sensor.

20. The method of claim 19, said method further comprising ceasing to draw said bodily fluid from said patient in response to detecting said arrival of said bodily fluid at said first sensor.

21. Apparatus for extracting and analyzing bodily fluids from a patient at the point of care for said patient comprising:

an infusion line having a patient end configured for fluid communication with a blood vessel of the patient;

a source of an infusion fluid, said source in fluid communication with said infusion line;

a reversible infusion pump coupled to the infusion line;

a body fluid sensor assembly mounted in fluid communication with the infusion line and including a first sensor, said first sensor configured to provide a signal indicative of a predetermined parameter of fluid present in the infusion line near said first sensor;

a controller that is configured to operate the infusion pump in a forward direction, to pump the infusion fluid through the infusion line toward the patient end, and that is configured to intermittently interrupt its operation of the infusion pump in the forward direction to operate the infusion pump in a rearward direction, to draw a body fluid sample from the patient through the patient end of the infusion line;

a fluid component separator mounted in fluid communication with said infusion line and configured to separate from said body fluid sample a first component of said body fluid sample.

22. The apparatus of claim 21, wherein said first sensor comprises an optical sensor.

23. The apparatus of claim 21, wherein the fluid component separator comprises a filter or a membrane.

24. The apparatus of claim 21, wherein the fluid component separator comprises a centrifuge.

25. The apparatus of claim 21, wherein the first component of the body fluid sample comprises blood plasma.

26. The apparatus of claim 21, wherein the first component of the body fluid sample has fewer impurities than the body fluid sample.

27. The apparatus of claim 21, wherein the predetermined parameter of the patient'"'"'s body fluid comprises glucose concentration.

28. The apparatus of claim 21, wherein the controller is configured to monitor the signal provided by the first sensor of the body fluid sensor assembly and to detect a change in the signal indicative of the arrival of the first component of the body fluid sample at the first sensor.

29. The apparatus of claim 28, wherein the controller is configured to cease its operating of the infusion pump in the rearward direction in response to detecting the arrival of the first component of the body fluid sample at the first sensor.

30. Apparatus for monitoring a predetermined parameter of a patient'"'"'s blood while infusing an infusion fluid into the patient, comprising:

an infusion line having a patient end configured for insertion into a blood vessel of the patient;

a source of an infusion fluid, said source in fluid communication with said infusion line;

a reversible infusion pump coupled to the infusion line;

a blood chemistry sensor assembly mounted in fluid communication with the infusion line and including a first sensor that provides a signal indicative of a predetermined parameter of fluid present in the infusion line;

a device operatively connected to the apparatus to provide one or more anti- clotting agents to at least a portion of said infusion line;

a controller configured to operate the infusion pump in a forward direction, to pump the infusion fluid through the patient end of the infusion line for infusion into the patient, and configured to intermittently interrupt its operation of the infusion pump in the forward direction to operate the infusion pump in a rearward direction, to draw a blood sample from the patient through the patient end of the infusion line into sensing contact with the first sensor of the blood chemistry sensor assembly.

31. The apparatus of claim 30, wherein the first sensor comprises an optical sensor.

32. The apparatus of claim 30, wherein said one or more anti-clotting agents comprises a detergent and wherein said device provides said detergent within at least a portion of said infusion line.

33. The apparatus of claim 32, wherein said detergent comprises a protease enzyme.

34. The apparatus of claim 30, wherein said device comprises an ultrasound transducer positionable to transmit ultrasound to said infusion line.

35. The apparatus of claim 34, wherein said ultrasound comprises a frequency within a range from about 15 kHz to about 60 kHz.

36. The apparatus of claim 34, wherein said ultrasonic transducer produces ultrasound having an ultrasonic power within a range from about 2 Watts to about 200 Watts.

37. The apparatus of claim 30, wherein the controller is configured to monitor the signal provided by the first sensor of the blood chemistry sensor assembly and to detect a change in the signal indicative of the arrival of the blood sample at the first sensor.

38. The apparatus of claim 37, wherein the controller is configured to cease its operating of the infusion pump in the rearward direction in response to detecting the arrival of the blood sample at the first sensor.

39. A patient status monitoring system, said system comprising:

a first body fluid analyzer;

a body fluid sensor assembly including a first sensor that provides a signal indicative of a predetermined parameter of fluid present in the body fluid sensor assembly;

a controller configured to monitor said signal from said body fluid sensor assembly and to detect a change in said signal indicative of an arrival of said fluid present in the body fluid sensor assembly at said first sensor;

a fluid passageway configured to provide fluid communication among said first body fluid analyzer, said body fluid sensor assembly, and a body fluid in a patient;

said first body fluid analyzer configured to be in communication with a data network, said data network including at least one data file; and

said first body fluid analyzer configured to access said at least one data file via said data network.

40. The patient status monitoring system of claim 39, wherein said first body fluid analyzer is configured to update said at least one data file.

41. The patient status monitoring system of claim 39, wherein said first sensor comprises an optical sensor.

42. The patient status monitoring system of claim 39, wherein said at least one data file contains calibration information for calibrating said first body fluid analyzer or said body fluid sensor assembly.

43. The patient status monitoring system of claim 39, wherein said at least one data file contains calibration information for calibrating said signal from said body fluid sensor assembly.

44. The patient status monitoring system of claim 39, said system further comprising:

a separate body fluid analyzer spaced apart from said first body fluid analyzer, said separate body fluid analyzer configured to be in communication with said data network; and

wherein said at least one data file contains separate measurement information relating to a measurement performed by said separate body fluid analyzer.

45. The patient status monitoring system of claim 44, wherein said first body fluid analyzer is configured to perform a first measurement on said body fluid sample and to compare information related to said first measurement with said separate measurement information from said separate body fluid analyzer.

46. The patient status monitoring system of claim 45, wherein said first body fluid analyzer is configured to use said compared information to verify the proper functioning of the first body fluid analyzer or the separate body fluid analyzer.

47. The patient status monitoring system of claim 46, wherein said first body fluid analyzer or said separate body fluid analyzer are configured to issue an alert if said compared information indicates improper functioning of said first body fluid analyzer or said separate body fluid analyzer.

48. The patient status monitoring system of claim 39, further comprising:

an infusion line having a patient end configured for insertion into a blood vessel of said patient;

a source of an infusion fluid, said source in fluid communication with said infusion line;

a reversible infusion pump coupled to said infusion line;

wherein said controller is configured to operate said infusion pump in a forward direction to pump said infusion fluid through said infusion line for infusion into said patient, and configured to intermittently interrupt its operation of said infusion pump in said forward direction to operate said infusion pump in a rearward direction, to draw a body fluid sample from said patient through said patient end of said infusion line into sensing contact with said first sensor of said body fluid sensor assembly; and

wherein said signal produced by said first sensor provides an indication of a predetermined parameter of said patient'"'"'s body fluid when said body fluid sample is in sensing contact with said first sensor.

49. The patient status monitoring system of claim 48, wherein said controller is configured to cease its operating of said infusion pump in said rearward direction in response to detecting said arrival of said body fluid sample at said first sensor.

50. The patient status monitoring system of claim 48, wherein said first sensor comprises an optical sensor.

51. The patient status monitoring system of claim 48, wherein said controller is configured to communicate said indication of said predetermined parameter to said data network.

52. The patient status monitoring system of claim 51, wherein said controller is configured to update said data file with said indication of said predetermined parameter.

53. An analyte detection system comprising:

a body fluid sensor assembly including a first sensor, the first sensor configured to provide information relating to a measurement of at least one analyte in a body fluid sample that is in sensing contact with the first sensor;

a processor; and

stored program instructions executable by said processor such that said system;

(a) identifies, based on said measurement, one or more possible interferents to the measurement of said at least one analyte in the body fluid sample;

(b) calculates a calibration which reduces error attributable to said one or more possible interferents;

(c) applies the calibration to the measurement; and

(d) estimates, based on the calibrated measurement, a concentration of said at least one analyte in the body fluid sample.

54. The analyte detection system of claim 53, wherein said at least one analyte comprises a first analyte and a second analyte.

55. The analyte detection system of claim 53, wherein said first sensor comprises an electrochemical sensor.

56. The analyte detection system of claim 53, wherein said first sensor comprises an optical sensor.

57. The analyte detection system of claim 53, said system further comprising:

an infusion line having a patient end configured for insertion into a blood vessel of a patient;

a source of an infusion fluid, said source in fluid communication with said infusion line;

a reversible infusion pump coupled to the infusion line;

a controller configured to operate the infusion pump in a forward direction, to pump the infusion fluid through the infusion line for infusion into the patient, and configured to intermittently interrupt its operation of the infusion pump in the forward direction to operate the infusion pump in a rearward direction, to draw the body fluid sample from the patient through the patient end of the infusion line into sensing contact with the first sensor of body fluid sensor assembly;

wherein the controller further is configured to monitor the signal provided by the first sensor of the body fluid sensor assembly and to detect a change in the signal indicative of the arrival of the body fluid sample at the first sensor.

58. The analyte detection system of claim 57, wherein the controller is configured to cease its operating of the infusion pump in the rearward direction in response to detecting the arrival of the body fluid sample at the first sensor.

59. The analyte detection system of claim 57, wherein the first sensor comprises an electrochemical sensor.

60. The analyte detection system of claim 57, wherein the first sensor comprises an optical sensor.

61. The analyte detection system of claim 60, further comprising a source of electromagnetic radiation, said source configured such that said radiation is directed to said optical sensor.

62. The analyte detection system of claim 61, further comprising a detector configured to detect radiation from said optical sensor.

63. The analyte detection system of claim 62, wherein said detector comprises a spectroscopic analyzer.

64. The analyte detection system of claim 63, wherein said spectroscopic analyzer comprises an infrared spectroscope.

65. Apparatus for analyzing the composition of bodily fluid, said apparatus comprising:

a first fluid passageway having a patient end which is configured to provide fluid communication with a bodily fluid within a patient;

at least one pump coupled to said first fluid passageway, said at least one pump configured to have an infusion mode in which said pump is operable to deliver infusion fluid to said patient through said patient end and a sample draw mode in which said pump is operable to draw a sample of said bodily fluid from said patient through said patient end;

a controller that is configured to operate said at least one pump in said infusion mode and in said sample draw mode;

a spectroscopic analyte detection system accessible via said first fluid passageway such that said analyte detection system can receive at least one component of said drawn sample of bodily fluid, and determine a concentration of at least one analyte, said analyte detection system being spaced from said patient end of said first fluid passageway;

a body fluid sensor assembly mounted in fluid communication with the first fluid passageway at or near said patient end and spaced from said analyte detection system, said body fluid sensor assembly including a first sensor and a second sensor;

wherein the first sensor is configured to sense a first property indicative of the fluid within said first fluid passageway and to provide a first signal indicative of said first property;

wherein the second sensor is configured to sense a second property indicative of the fluid within said first fluid passageway and to provide a second signal indicative of said second property; and

wherein the controller is configured to monitor the first signal provided by the first sensor and to detect a change in the first signal indicative of an arrival of the drawn sample of body fluid at the first sensor.

66. The apparatus of claim 65, wherein the controller is configured to signal said at least one pump to cease said sample draw mode in response to the change in the first signal indicative of the arrival of the drawn sample of body fluid at the first sensor.

67. The apparatus of claim 65, wherein said first sensor is selected from the group consisting of a calorimetric sensor, a hemoglobin sensor, a hematocrit sensor, a pressure sensor, a dilution sensor, and a bubble sensor.

68. The apparatus of claim 65, wherein the first property comprises a color or a rate of change of a color of the fluid within said first fluid passageway.

69. The apparatus of claim 65, wherein the second sensor comprises an electrochemical sensor.

70. The apparatus of claim 65, wherein the second sensor comprises an optical sensor.

71. A fluid handling and analysis system, said system comprising:

a fluid transport network comprising at least a first fluid passageway, said fluid transport network including a patient end configured to maintain fluid communication with a bodily fluid in a patient;

a sample analysis chamber and waste container, each accessible by said fluid transport network;

a bodily fluid sensor assembly in fluid communication with said fluid transport network and including a first sensor that provides a signal indicative of a predetermined parameter of fluid present in said first fluid passageway;

a pump unit in operative engagement with said fluid transport network, said pump unit configured to have an infusion mode in which said pump unit delivers an infusion fluid to said patient through said patient end and a sample draw mode in which said pump unit draws a volume of said bodily fluid from said patient through said patient end, toward said sample analysis chamber;

wherein said fluid transport network and said pump unit are configured to draw a volume of said bodily fluid from said patient, isolate a fraction of said bodily fluid from said volume, and pass said fraction to said sample analysis chamber and then to said waste container.

72. The system of claim 71, wherein said first sensor comprises an optical sensor.

73. The system of claim 71, further comprising a spectroscopic fluid analyzer configured to analyze said fraction of said bodily fluid in said sample analysis chamber and to determine a concentration of at least one analyte in said fraction.

74. The system of claim 71, wherein said pump unit comprises a first pump operable in said infusion mode and a second pump operable in said sample draw mode.

75. The system of claim 71, wherein said pump unit is directionally controllable.

76. The system of claim 71, wherein said pump unit is further configured to return a remainder of said drawn volume of bodily fluid to said patient via said fluid transport network.

77. The system of claim 76, further comprising one or more valves configured to assist the pump unit to selectively draw a volume of said bodily fluid from said patient, isolate a fraction of said bodily fluid from said volume, pass said fraction to said sample analysis chamber and then to said waste container, and to return a remainder of said drawn volume of bodily fluid to said patient via said fluid transport network.

78. The system of claim 71, further comprising a controller configured to monitor the signal provided by the first sensor and to detect a change in the signal indicative of an arrival of the drawn bodily fluid at the first sensor.

79. The system of claim 78, wherein the controller is configured to operate said pump unit in said infusion mode and said sample draw mode.

80. The system of claim 79, wherein the controller is configured to signal said pump unit to cease said sample draw mode in response to said change in said signal indicative of the arrival of said drawn bodily fluid at the first sensor.

81. Apparatus for monitoring a predetermined parameter of a patient'"'"'s body fluid while infusing an infusion fluid into the patient, comprising:

an infusion line having a patient end configured for insertion into a blood vessel of the patient;

a source of an infusion fluid, said source in fluid communication with said infusion line;

a reversible infusion pump coupled to the infusion line;

a body fluid sensor assembly mounted in fluid communication with the infusion line, said sensor assembly including a temperature sensor that provides temperature information relating to fluid present in the body fluid sensor assembly, and a first sensor that provides a signal indicative of a parameter of fluid present in the body fluid sensor assembly;

a controller configured to operate the infusion pump in a forward direction, to pump the infusion fluid through the infusion line for infusion into the patient, and configured to intermittently interrupt its operation of the infusion pump in the forward direction to operate the infusion pump in a rearward direction, to draw a body fluid sample from the patient through the patient end of the infusion line into sensing contact with the first sensor and the temperature sensor of the body fluid sensor assembly;

wherein the controller further is configured to monitor the signal provided by the first sensor of the body fluid sensor assembly and to detect a change in the first signal indicative of an arrival of the body fluid sample at the first sensor;

wherein the signal produced by the first sensor provides an indication of a predetermined parameter of the patient'"'"'s body fluid when the body fluid sample is in sensing contact with the first sensor; and

wherein the controller is configured to acquire the temperature information and to use the temperature information when determining said predetermined parameter of the patient'"'"'s body fluid.

82. The apparatus of claim 81, wherein the first sensor comprises an optical sensor.

83. The apparatus of claim 81, wherein the temperature sensor comprises a thermistor.

84. The apparatus of claim 81, wherein the controller is configured to cease its operation of the infusion pump in the rearward direction in response to detecting the arrival of the body fluid sample at the first sensor.

85. The apparatus of claim 81, wherein the body fluid sensor assembly further comprises a thermal device configured to regulate a temperature of the drawn body fluid sample.

86. The apparatus of claim 85, wherein the thermal device comprises a thermoelectric device.

87. The apparatus of claim 86, wherein the thermoelectric device comprises a resistor.

88. The apparatus of claim 86, wherein the thermoelectric device comprises a Peltier device.

89. The apparatus of claim 86, wherein the thermoelectric device is operable in a heating mode and in a cooling mode.

90. The apparatus of claim 85, wherein the thermal device is configured to regulate the temperature to be substantially equal to a body temperature of the patient.

91. The apparatus of claim 85, wherein the thermal device further comprises a temperature control system.

92. The apparatus of claim 91, wherein the temperature control system comprises a proportional, integral, derivative (PID) control system.