System and method for measuring a bioanalyte such as lactate

• US 6,128,519 A
• Filed: 12/16/1998
• Issued: 10/03/2000
• Est. Priority Date: 12/16/1998
• Status: Expired due to Term

• Current Assignee: Pepex Biomedical, Inc.
• Original Assignee: Pepex Biomedical, LLC
• Inventors: Say, James I
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US09/212,557
• Time in Patent Office: 657 Days
• Field of Search: 600/345, 600/366, 600/368, 600/322, 600/309, 600/347
• US Class Current: 600/345
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes

Abstract

The present disclosure relates to a sensor assembly including a catheter having a catheter sheath adapted for insertion in a patient, and a catheter hub connected to the catheter sheath. An adapter is connected to the catheter hub. The adapter includes first and second ports. A first flow line extends between the first port and a pump. A sensor is positioned along the first flow line. A second flow line extends between the second port and a container for holding a calibration fluid. The adapter defines first and second separate passages. The first passage extends from the first port to an interior region of the catheter sheath. The second passage extends from the second port to the interior region of the catheter hub.

Claims

1. A sensor assembly comprising:

a catheter including a catheter sheath adapted for insertion in a patient, and a catheter hub connected to the catheter sheath;

an adapter connected to the catheter hub, the adapter including first and second ports;

a pump;

a first flow line extending between the adapter and the pump, the first flow line being connected to the first port of the adapter;

a sensor positioned along the first flow line;

a container for holding a calibration fluid, the calibration fluid including a calibrant adapted for use in calibrating the sensor;

a second flow line extending between the adapter and the container, the second flow line being connected to the second port of the adapter; and

the adapter defining first and second separate passages, the first passage extending from the first port to an interior region of the catheter sheath, and the second passage extending from the second port to an interior region of the catheter hub.

2. The sensor assembly of claim 1, wherein the sensor comprises a lactate sensor.

3. The sensor assembly of claim 1, wherein the container comprises an intravenous bag.

4. The sensor assembly of claim 1, wherein the pump comprises a syringe.

5. The sensor assembly of claim 1, wherein the adapter includes an insertion portion that fits within the catheter hub, wherein the first passage is defined by a conduit that extends through the insertion portion, and wherein the conduit has an end portion that extends outward from the insertion portion and into the catheter sheath.

6. The sensor assembly of claim 5, wherein the insertion portion includes a frustral conical shaped portion, wherein the frustral conical shaped portion has a first end having a minor diameter and a second end having a major diameter, and wherein the end portion of the conduit projects axially outward from the first end.

7. The sensor assembly of claim 5, wherein the insertion portion of the adapter defines at least a portion of the second passage.

8. The sensor assembly of claim 7, wherein the portion of the second passage defined by the insertion portion of the adapter at least partially surrounds the conduit defining the first passage.

9. The sensor assembly of claim 7, wherein the portion of the second passage defined by the insertion portion of the adapter concentrically surrounds the conduit defining the first passage.

10. The sensor assembly of claim 1, wherein first passage is at least partially defined by a conduit that extends into the catheter sheath and terminates adjacent a distal tip of the catheter sheath.

11. The sensor assembly of claim 10, wherein the conduit terminates at a location not greater than 1 centimeter from the distal tip of the catheter sheath.

12. The sensor assembly of claim 10, wherein the conduit terminates at a location not greater than 1 millimeter from the distal tip of the catheter sheath.

13. A sensor assembly comprising:

a catheter including a catheter sheath adapted for insertion in a patient;

first structure defining a first flow passage that extends within the catheter sheath and terminates within an interior region of the catheter sheath;

second structure defining a second flow passage separate from the first flow passage, the second flow passage terminating within the interior region of the catheter sheath;

a sensor positioned in fluid communication with the first flow passage;

a source of calibration fluid in fluid communication with the second flow passage, the source of calibration fluid including calibration fluid that is conveyed to the interior region of the catheter sheath through the second flow passage, the calibration fluid being adapted for use in calibrating the sensor; and

a pump in fluid communication with the first flow passage, the pump being adapted for drawing a fluid from the interior region of the catheter sheath to the sensor.

14. The sensor assembly of claim 13, wherein the first structure includes a conduit inserted within the catheter sheath, the conduit at least partially defining the first flow passage, and the conduit having an end positioned within the catheter sheath at a location adjacent a distal tip of the catheter.

15. The catheter assembly of claim 14, wherein the second flow passage is at least partially defined between the conduit and the catheter sheath.

16. The catheter assembly of claim 14, wherein at least a portion of the second passage circumferentially surrounds the conduit within the catheter sheath.

17. An adapter for use with a catheter including a catheter sheath connected to a catheter hub, the catheter sheath being adapted for insertion in a patient, the adapter comprising:

an adapter body defining first and second ports adapted for connection to medical tubing;

a connecting member adapted to fasten the adapter body to the hub;

a conduit extending from the first port through the adapter body, the conduit including an end portion that projects outward from the adapter body, the end portion being arranged and configured to fit within an interior region of the catheter sheath when the adapter body is connected to the catheter hub; and

structure defining a passage separate from the conduit that extends from the second port through the adapter body, the passage being arranged and configured to provide fluid communication between the second port and an interior region of the catheter hub when the adapter body is connected to the catheter hub.

18. The sensor assembly of claim 17, wherein the adapter includes an insertion portion sized and shaped to fit within the catheter hub, and wherein the end portion of the conduit extends outward from the insertion portion.

19. The sensor assembly of claim 18, wherein the insertion portion includes a generally frustral conical shaped portion, wherein the frustral conical shaped portion has a first end having a minor diameter and a second end having a major diameter, and wherein the end portion of the conduit projects axially outward from the first end.

20. The sensor assembly of claim 18, wherein the insertion portion of the adapter defines at least a portion of the passage.

21. The sensor assembly of claim 20, wherein the portion of the second passage defined by the insertion portion of the adapter at least partially surrounds the conduit within the insertion portion.

22. The sensor assembly of claim 20, wherein the portion of the second passage defined by the insertion portion of the adapter concentrically surrounds the conduit within the insertion portion.

23. A method of operating a sensor assembly, the sensor assembly comprising:

a catheter including a catheter sheath adapted for insertion in a patient;

a conduit defining a first flow passage in fluid communication with a pump, the conduit being inserted within the catheter sheath and including an end positioned adjacent a distal end of the catheter sheath; and

a second flow passage defined at least partially between the conduit and the catheter sheath, the method comprising;

inserting the catheter sheath into the patient;

conveying calibration fluid through the second flow passage to a fluid exchange region located within the catheter sheath adjacent the distal tip of the catheter sheath;

calibrating the sensor by drawing the calibration fluid from the fluid exchange region through the first flow passage, and conveying the calibration fluid past the sensor;

terminating the conveyance of calibration fluid to the fluid exchange region;

drawing a test sample from the patient into the fluid exchange region after the conveyance of calibration fluid to the fluid exchange region has been terminated;

drawing the test sample from the fluid exchange region through the first flow passage and to the sensor; and

sensing the sample fluid with the sensor.

24. The method of claim 23, wherein the sensor comprises a lactate sensor.

25. The method of claim 23, wherein during calibration, the calibration fluid is conveyed to the fluid exchange region of the catheter sheath at a first flow rate that is at least two times as fast as a second flow rate that the calibration fluid is withdrawn from the fluid exchange region and conveyed to the sensor.