Apparatus and methods for analyzing body fluid samples

• US 20060189926A1
• Filed: 12/21/2005
• Published: 08/24/2006
• Est. Priority Date: 02/14/2005
• Status: Abandoned Application

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Gable, Jennifer H., Braig, James R., Wechsler, Mark, Keenan, Richard, Rule, Peter, Hall, W. Dale, Callicoat, David N., Witte, Kenneth G.
• Application Number:
  US11/316,407
• Publication Number:
  US 20060189926A1
• 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 B. 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 while infusing an infusion fluid into the patient, comprising:

an infusion line and a catheter configured for insertion into a blood vessel of the patient;

a reversible infusion pump connected between a source of an infusion fluid and the infusion line and catheter;

a body fluid sensor assembly mounted in fluid communication with the infusion line and including a first sensor and a sample cell, said first sensor providing a signal indicative of a predetermined parameter of any fluid present in the infusion line and said sample cell being substantially transmissive to light comprising a wavelength λ

;

a controller that is configured to operate the infusion pump in a forward direction, to pump the infusion fluid through the infusion line and catheter for infusion into the patient, and that is configured to intermittently interrupt its operating 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 catheter and infusion line;

wherein 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 said sample cell 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 signal indicative of the arrival of the body fluid sample at the first sensor;

wherein 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; and

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.

2. The apparatus of claim 1, wherein the sample cell comprises one or more windows that are substantially transmissive to light comprising the wavelength λ

.

3. The apparatus of claim 1 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.

4. The apparatus of claim 3, wherein the optical path comprises one or more optical fibers.

5. The apparatus of claim 3, wherein the wavelength λ

is in the infrared.

6. The apparatus of claim 3, wherein the wavelength λ

is in the range from 1 micron to 20 microns.

7. The apparatus of claim 3, wherein the wavelength λ

is in the range from 7 microns to 10 microns.

8. The apparatus of claim 3, wherein the light detector is a spectrometer.

9. The apparatus of claim 3, 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 the second portion of the body fluid sample and a portion of the light is directed to the light detector along the optical path.

10. The apparatus of claim 9, wherein the light is transmitted through the second portion of the body fluid sample.

11. The apparatus of claim 9, wherein the light is reflected from the second portion of the body fluid sample.

12. 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;

monitoring a signal produced by said first sensor of the sensor assembly and detecting a change in the signal indicative of an arrival of said bodily fluid at said first sensor;

ceasing to draw said bodily fluid from said patient in response to detecting said arrival of said bodily fluid at said first sensor;

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.

13. The method of claim 12, said method further comprising monitoring said first sensor signal while said bodily fluid is in sensing contact with said first sensor, to produce a measurement of a parameter of said bodily fluid.

14. The method of claim 12, wherein said separating comprises filtering said first component from said drawn portion of bodily fluid.

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

an infusion line and a catheter configured for insertion into a blood vessel of the patient;

a reversible infusion pump connected between a source of an infusion fluid and the infusion line and catheter;

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 any fluid present in the infusion line;

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

a controller that operates the infusion pump in a forward direction, to pump the infusion fluid through the infusion line and catheter for infusion into the patient, and that intermittently interrupts its operating 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 catheter and infusion line into sensing contact with the first sensor of the blood chemistry sensor assembly;

wherein the controller further 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;

wherein the controller, in response to detecting the arrival of the blood sample at the first sensor, ceases its operating of the infusion pump in the rearward direction;

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

16. The apparatus of claim 15, wherein said one or more anti-clotting agents comprises a detergent and where said device provides said detergent within at least a portion of said infusion line.

17. The apparatus of claim 16, wherein said detergent comprises a protease enzyme.

18. The apparatus of claim 15, wherein said anti-clotting device comprises an ultrasound generator positionable to transmit an ultrasonic energy to said infusion line.

19. The apparatus of claim 18, wherein said ultrasonic energy comprises a frequency within a range from about 15 kHz to about 60 kHz.

20. The apparatus of claim 18, wherein said ultrasonic generator generates an ultrasonic power within a range from about 2 Watts to about 200 Watts.

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

a body fluid analyzer;

a body fluid sensor assembly including a first sensor that provides a signal indicative of a predetermined parameter of any 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 body fluid sample at said first sensor;

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

said controller configured to be in communication with a data network;

said data network configured to include at least one data file;

said controller configured to access said at least one data file via said data network.

22. The patient status monitoring system of claim 21, wherein the body fluid sensor assembly comprises the controller.

23. The patient status monitoring system of claim 21, wherein the body fluid analyzer comprises the controller.

24. The patient status monitoring system of claim 21, wherein said at least one data file contains calibration information for calibrating said body fluid analyzer or said body fluid sensor assembly.

25. The patient status monitoring system of claim 21, wherein said controller is configured to update said at least one data file.

26. The patient status monitoring system of claim 21, further comprising:

an infusion line and a catheter configured for insertion into a blood vessel of said patient;

a reversible infusion pump connected between a source of an infusion fluid and said infusion line and catheter;

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

wherein said controller in response to detecting said arrival of said body fluid sample at said first sensor, ceases its operating of said infusion pump in said rearward direction; 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.

27. The patient status monitoring system of claim 24, wherein said controller is configured to communicate said indication of said predetermined parameter to said data network.

28. The patient status monitoring system of claim 27, wherein said controller is configured to update said data file with said indication of said predetermined parameter.

29. 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.

30. The analyte detection system of claim 29, wherein said at least one analyte comprises a first analyte and a second analyte.

31. The analyte detection system of claim 29, said system further comprising:

an infusion line and a catheter configured for insertion into a blood vessel of a patient;

a reversible infusion pump fluidly connected between a source of an infusion fluid and the infusion line and catheter, the infusion pump and the body fluid sensor assembly configured to be in fluid communication with the infusion line;

a controller that operates the infusion pump in a forward direction, to pump the infusion fluid through the infusion line and catheter for infusion into the patient, and that intermittently interrupts its operating 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 catheter and 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; and

wherein the controller, in response to detecting the arrival of the body fluid sample at the first sensor, ceases its operating of the infusion pump in the rearward direction.

32. The analyte detection system of claim 31, wherein the controller comprises the processor.

33. The analyte detection system of claim 31, wherein the body fluid sensor assembly comprises the processor.

34. The analyte detection system of claim 31, wherein the first sensor comprises an electrochemical sensor.

35. The analyte detection system of claim 31, wherein the first sensor comprises an optical sensor.

36. The analyte detection system of claim 35, further comprising a source of electromagnetic radiation, said source configured such that said radiation is directed to said optical sensor.

37. The analyte detection system of claim 36, further comprising a detector configured to detect radiation from said optical sensor.

38. The analyte detection system of claim 37, wherein said detector comprises a spectroscopic analyzer.

39. The analyte detection system of claim 38, wherein said spectroscopic analyzer comprises an infrared spectroscope.

40. 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 having 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 configured to sense a property of the fluid within said first fluid passageway and to provide a signal indicative of said property; and

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 at the first sensor.

41. The apparatus of claim 40, 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 signal indicative of the arrival of the body fluid at the first sensor.

42. The apparatus of claim 40, wherein said first sensor is selected from the group consisting of a colorimetric sensor, a hemoglobin sensor, a hematocrit sensor, a pressure sensor, a dilution sensor, and a bubble sensor.

43. 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 any fluid present in said first fluid passageway;

a pump unit in operative engagement with said fluid transport network, said pump unit having 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;

a spectroscopic fluid analyzer configured to analyze a sample of said of bodily fluid while said sample is in said sample analysis chamber, and determine a concentration of at least one analyte;

said fluid transport network and said pump unit being 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.

44. The system of claim 43, wherein said pump unit comprises a first pump operable in said infusion mode and a second pump operable in said sample draw mode.

45. The system of claim 43, wherein said pump unit is directionally controllable.

46. The system of claim 43, 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

47. The system of claim 46, 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.

48. The system of claim 43, further comprising:

a controller configured to operate said pump unit in said infusion mode and said sample draw mode and to monitor the signal provided by the first sensor of the bodily fluid sensor assembly and to detect a change in the signal indicative of the arrival of the bodily fluid sample at the first sensor.

49. The system of claim 48, 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 bodily fluid at the first sensor.

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

an infusion line and a catheter configured for insertion into a blood vessel of the patient;

a reversible infusion pump connected between a source of an infusion fluid and the infusion line and catheter;

a body fluid sensor assembly mounted in fluid communication with -the infusion line and including a first sensor that provides a signal indicative of a parameter of any fluid present in the body fluid sensor assembly and further including a thermal device;

a controller that operates the infusion pump in a forward direction, to pump the infusion fluid through the infusion line and catheter for infusion into the patient, and that intermittently interrupts its operating 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 catheter and infusion line into sensing contact with the first sensor and the thermal device 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 controller, in response to detecting the arrival of the body fluid sample at the first sensor, ceases its operating of the infusion pump in the rearward direction;

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 communicate with the thermal device so as to regulate a temperature of the body fluid sample.

51. The apparatus of claim 50, wherein the body fluid sensor assembly further comprises a temperature sensor.

52. The apparatus of claim 50, wherein the thermal device comprises a thermoelectric device.

53. The apparatus of claim 52, wherein the thermoelectric device comprises a resistor.

54. The apparatus of claim 52, wherein the thermoelectric device comprises a Peltier device.

55. The apparatus of claim 52, wherein the thermoelectric device is operable in a heating mode and in a cooling mode.

56. The apparatus of claim 52, wherein the controller regulates the temperature to be substantially equal to a body temperature of the patient.

57. The apparatus of claim 52, further comprising a proportional, integral, derivative (PID) control system to enable temperature regulation.