APPARATUS AND METHODS FOR ANALYZING BODY FLUID SAMPLES

• US 20100030137A1
• Filed: 07/28/2009
• Published: 02/04/2010
• Est. Priority Date: 02/14/2005
• Status: Abandoned Application

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Callicoat, David N., Witte, Kenneth G., Gable, Jennifer H., Braig, James R., Wechsler, Mark, Keenan, Richard, Rule, Peter, Hall, W. Dale
• Application Number:
  US12/511,014
• Publication Number:
  US 20100030137A1
• 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 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.

2. The apparatus of claim 1, wherein the first sensor comprises an optical sensor.

3. The apparatus of claim 1, wherein the temperature sensor comprises a thermistor.

4. The apparatus of claim 1, 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.

5. The apparatus of claim 1, wherein the controller is further configured to normalize a measurement of the body fluid sample to a reference temperature.

6. The apparatus of claim 5, wherein the controller is configured to normalize the measurement of the body fluid sample based at least in part on a temperature-dependent signal analysis model.

7. The apparatus of claim 5, wherein the first sensor comprises an optical sensor, and the controller is configured to normalize the measurement of the body fluid sample based at least in part on differentials applied to the signal provided by the optical sensor.

8. The apparatus of claim 1, wherein the body fluid sensor assembly further comprises a thermal device configured to regulate a temperature of the drawn body fluid sample.

9. The apparatus of claim 8, wherein the thermal device comprises a thermoelectric device.

10. The apparatus of claim 9, wherein the thermoelectric device comprises a resistor.

11. The apparatus of claim 9, wherein the thermoelectric device comprises a Peltier device.

12. The apparatus of claim 9, wherein the thermoelectric device is operable in a heating mode and in a cooling mode.

13. The apparatus of claim 8, wherein the thermal device is configured to regulate the temperature of the body fluid sample to a reference temperature.

14. The apparatus of claim 13, wherein the reference temperature is substantially equal to a body temperature of the patient.

15. The apparatus of claim 8, wherein the thermal device further comprises a temperature control system.

16. The apparatus of claim 15, wherein the temperature control system comprises a proportional, integral, derivative (PID) control system.

17. The apparatus of claim 8, wherein the thermal device is disposed along the infusion line.

18. 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 body fluid in a patient;

a body fluid analyzer 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 body fluid analyzer;

a thermal system configured to determine a temperature of at least a portion of the fluid present in said body fluid analyzer; and

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 body fluid from said patient through said patient end, toward said body fluid analyzer,

wherein said body fluid analyzer is configured to estimate a concentration of an analyte in the fluid present in said body fluid analyzer, said estimated concentration based at least in part on the temperature determined by the thermal system.

19. The system of claim 18, wherein the body fluid analyzer is configured to normalize a measurement of the body fluid present in said body fluid analyzer to a reference temperature.

20. The system of claim 18, wherein the body fluid analyzer is configured to estimate the concentration of the analyte based at least in part on a temperature-dependent signal analysis model.

21. The system of claim 18, wherein the thermal system is further configured to regulate the temperature of at least a portion of the fluid present in the body fluid analyzer to a baseline temperature.

22. The system of claim 21, wherein the thermal system comprises a thermoelectric device.

23. The system of claim 22, wherein the thermal system further comprises a proportional-plus-integral-plus-derivative (PID) controller.

24. The system of claim 18, wherein said fluid transport network and said pump unit are further configured to separate a sample from said volume of body fluid, and pass said sample to a sample analysis chamber for estimation of the concentration of the analyte present in the sample analysis chamber.

25. The system of claim 18, wherein said system is 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 body fluid at the first sensor.

26. The system of claim 18, wherein said body fluid analyzer comprises a spectroscopic fluid analyzer.

27. 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 body fluid in a patient;

a body fluid analyzer 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 body fluid analyzer;

a thermal system configured to determine a temperature of at least a portion of the fluid present in said body fluid analyzer; and

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 body fluid from said patient through said patient end, toward said body fluid analyzer;

wherein said body fluid analyzer is configured to estimate a concentration of an analyte in the fluid present in said body fluid analyzer.

28. The system of claim 27, further comprising an output device that is configured to output information related to the temperature determined by the thermal system.

29. The system of claim 28, wherein the output device comprises a display.

30. The system of claim 27, wherein the thermal system comprises a thermistor.

31. The system of claim 27, wherein the body fluid analyzer comprises a spectroscope.