System and method for measuring a bioanalyte such as lactate

• US 6,117,290 A
• Filed: 07/24/1998
• Issued: 09/12/2000
• Est. Priority Date: 09/26/1997
• Status: Expired due to Fees

• Current Assignee: Rubicon Investments, Inc.
• Original Assignee: Pepex Biomedical, LLC
• Inventors: Say, James L., Sakslund, Henning, Peper, Eric A., Long, Nathan R.
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/122,496
• Time in Patent Office: 781 Days
• Field of Search: 204/403, 204/400, 204/409, 422/82.01, 422/82.05, 604/181, 604/187, 604/218
• US Class Current: 600/352
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001

Abstract

The present disclosure relates to an on-line lactate sensor arrangement. The sensor arrangement includes a lactate sensor, a catheter for withdrawing a test sample, and a first fluid flow line provided fluid communication between the lactate sensor and the catheter. The sensor arrangement also includes a source of sensor calibration and anticoagulant solution, and second fluid flow line providing fluid communication between the source of sensor calibration and anticoagulant solution and the lactate sensor.

Claims

1. An on-line lactate sensor arrangement comprising:

a lactate sensor;

a first fluid flow line for drawing a fluid sample from a patient and conveying the fluid sample to the lactate sensor;

a source of sensor calibration fluid;

a second fluid flow line providing fluid communication between the source of sensor calibration fluid and the lactate sensor; and

a source of pressure for pushing sensor calibration fluid from the source of sensor calibration fluid toward the lactate sensor, and a source of vacuum for drawing the fluid sample from the patient toward the lactate sensor, wherein both the source of pressure and the source of vacuum are provided by a syringe.

2. The sensor arrangement of claim 1, wherein the lactate sensor is an electrochemical sensor.

3. The sensor arrangement of claim 2, wherein the lactate sensor includes a flexible circuit board.

4. The sensor arrangement of claim 1, wherein the lactate sensor includes an electrode covered with a sensing layer including a redox compound and a redox enzyme.

5. The sensor arrangement of claim 4, wherein the redox enzyme includes lactate oxidase.

6. The sensor arrangement of claim 4, wherein the redox enzyme includes lactate dehydrogenase.

7. The sensor arrangement of claim 1, wherein the first and second fluid flow lines form at least portions of a valveless flow path extending between the patient and the source of sensor calibration fluid.

8. The sensor arrangement of claim 1, further comprising a sensor housing defining a test chamber in fluid communication with the first and second flow lines, at least a portion of the sensor being positioned within the test chamber.

9. The sensor arrangement of claim 1, wherein the test chamber has a depth less than 0.1 inch.

10. The sensor arrangement of claim 1, wherein the test chamber has a width in the range of 0.05 to 0.07 inch.

11. The sensor arrangement of claim 1, wherein the first flow line has an inner diameter less than 0.1 inch.

12. The sensor arrangement of claim 1, wherein the syringe defines a piston chamber and includes a piston mounted for reciprocal movement within the chamber, the chamber being formed by a side wall defining a first port and a base defining a second port, the first port providing fluid communication between the chamber and the source of sensor calibration fluid, and the second port providing fluid communication between the chamber and the second fluid flow line.

13. The sensor arrangement of claim 12, wherein the first port is positioned proximate a top portion of the side wall.

14. The sensor arrangement of claim 12, wherein the piston is moveable between a first position in which the piston blocks the first port such that sensor calibration fluid is inhibited from entering the chamber through the first port, and a second position in which the first port is open and sensor calibration fluid can enter the chamber through the first port.

15. The sensor arrangement of claim 12, wherein the piston includes a blocking portion for blocking the first port, the blocking portion having a length that is at least as long as a maximum stroke length of the piston.

16. The sensor arrangement of claim 12, wherein the piston is adapted to force sensor calibration fluid out of the chamber through the second port, and the piston covers the first port when sensor calibration fluid is being forced through the second port by the piston.

17. The sensor arrangement of claim 1, further comprising a controller for causing the springe to draw the blood sample through the first flow line and past the lactate sensor at a flow rate less than 50 microliters per minute.

18. The sensor arrangement of claim 1, wherein the calibration fluid also includes an anticoagulant.

19. The sensor arrangement of claim 1, wherein the calibrant includes lactate.

20. The sensor arrangement of claim 1, further comprising a controller for automatically drawing fluid samples at pre-set times and testing the samples for lactate.

21. The sensor arrangement of claim 20, wherein the fluid samples are drawn at predetermined time intervals.

22. The sensor arrangement of claim 20, wherein lactate readings generated by the lactate sensor are stored in memory associated with the controller.

39. The sensor arrangement of claim 1, further comprising a controller for causing the springe to draw the blood sample through the first flow line and past the lactate sensor at a flow rate less than 100 microliters per minute.

23. A sensor arrangement comprising:

a sensor;

a syringe including a syringe housing defining a piston chamber having a longitudinal axis and a piston mounted within the chamber, the piston being reciprocally moveable within the chamber along the longitudinal axis, the syringe housing defining first and second ports that provide access to the piston chamber, the first port being spaced from the second port in a direction extending generally along the longitudinal axis;

a first fluid flow line providing fluid communication between the sensor and a sample fluid;

a second fluid flow line providing fluid communication between the second port of the syringe housing and the sensor; and

a source of calibrant solution including calibrant for calibrating the sensor, the source of calibrant solution being in fluid communication with the first port of the syringe housing.

24. The sensor arrangement of claim 23, wherein the first and second fluid flow lines form at least portions of a valveless flow path extending from the sample fluid, past the sensor, to the second port of the syringe.

25. The sensor arrangement of claim 24, wherein when the piston is moved in a first direction relative to the syringe housing, calibrant solution is forced out the second port into the second flow line and past the sensor thereby allowing the sensor to be calibrated, and when the piston is moved in a second direction relative to the syringe housing, sample fluid is drawn through the medical device into the first flow line and past the sensor thereby allowing the sample fluid to be tested by the sensor.

26. The sensor arrangement of claim 23, wherein the syringe housing includes a first end portion positioned opposite from a second end portion, and a side wall extending between the first and second end portions, the first port being defined by the side wall and the second port being defined by one of the first and second end portions of the housing.

27. The sensor arrangement of claim 26, wherein the first port extends in a radial direction relative to the longitudinal axis, and the second port extends in an axial direction relative to the longitudinal axis.

28. The sensor arrangement of claim 23, wherein the piston is moveable between a first position in which the piston blocks the first port such that calibration solution is inhibited from entering the chamber through the first port, and a second position in which the first port is open and the calibration solution can enter the chamber through the first port.

29. The sensor arrangement of claim 23, wherein the piston includes a blocking portion for blocking the first port, the blocking portion having a length that is at least as long as a maximum stroke length of the piston.

30. The sensor arrangement of claim 23, wherein the piston is adapted to force calibration solution out of the chamber through the second port, and the piston covers the first port when the calibration solution is being forced through the second port by the piston.

31. The sensor arrangement of claim 23, wherein the sensor is a lactate sensor.

32. The sensor arrangement of claim 31, wherein the lactate sensor is an electrochemical sensor.

33. The sensor arrangement of claim 23, wherein first flow line is coupled to a catheter.

34. The sensor arrangement of claim 23, wherein the calibrant solution includes an anti-coagulant.

35. The sensor arrangement of claim 23, wherein the calibrant solution includes lactate.

36. A fluid control device comprising:

a housing defining a piston chamber having a longitudinal axis, the housing defining first and second ports that provide access to the piston chamber, the first port being spaced from the second port in a direction generally along the longitudinal axis; and

a piston mounted within the piston chamber and reciprocally moveable along the longitudinal axis, the piston including a blocking portion for blocking and unblocking the first port, the blocking portion having a length that is at least as long as a maximum stroke length of the piston, the maximum stroke length of the piston being measured from a top of the first port to a farthest point the piston penetrates within the piston chamber.

37. The fluid control device of claim 36, wherein the housing includes a first end portion positioned opposite from a second end portion, and a side wall extending between the first and second end portions, the first port being defined by the side wall and the second port being defined by one of the first and second end portions of the housing.

38. The fluid control device of claim 37, wherein the first port extends in a radial direction relative to the longitudinal axis, and the second port extends in an axial direction relative to the longitudinal axis.