SENSOR SYSTEMS AND METHODS OF USING THE SAME

• US 20150282751A1
• Filed: 10/11/2013
• Published: 10/08/2015
• Est. Priority Date: 10/31/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Konno, Mark A.
• Granted Patent: US 9,907,503 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6866 Extracorporeal blood circuits, e.g. dialysis circuits
• CPC Class Codes: A61M 5/16813 by controlling the degree of opening of the flow line

Abstract

Provided are sensor systems and methods for detecting analytes of bodily fluids. The systems can be used to reduce the administration volume of certain compounds and/or fluids during medical monitoring or other procedures by providing a calibration path configured to receive a first fluid, a sample path isolated from the calibration path, the sample path configured to receive a bodily fluid from a subject, and a sensor apparatus comprising at least one sensor selectively positionable between the calibration path and the sample path.

Claims

1. A sensor system, comprising:

a calibration path configured for fluid communication with a first fluid;

a sample path isolated from the calibration path, the sample path adapted to be placed in fluid communication with a bodily fluid of a subject and configured to accept at least a portion of the bodily fluid into the sample path, and

a sensor apparatus comprising at least one sensor, wherein the sensor is configured to sense at least one analyte in the bodily fluid, wherein the sensor is selectably moveable between a first configuration wherein at least a portion of the sensor is located in the calibration path and a second configuration wherein at least a portion of the sensor is located in the sample path.

2. The sensor system of claim 1, wherein a valve is disposed between the sample path and the calibration path, the valve permitting movement of at least a portion of the sensor between the calibration path and the sample path.

3. The sensor system of claim 2, wherein the sensor is advanced through the valve from the first configuration to the second configuration.

4. The sensor system of claim 2, wherein the sensor is retracted from the second configuration to the first configuration.

5. The sensor system of claim 2, wherein the valve impedes flow of the first fluid into the sample path.

6. The sensor system of claims 2, wherein the valve impedes flow of bodily fluid into the calibration path.

7. The sensor system of claim 2, wherein the valve comprises a resealable aperture.

8. The sensor system of claim 7, wherein the at least a portion of the sensor apparatus, including the sensor, is advanced through the valve aperture as the sensor is moved from the calibration path into the sample path.

9. The sensor system of claim 8, wherein the valve seals about at least a portion of the sensor apparatus when the sensor is positioned in the sample path to impede fluid flow between the sample path and the calibration path.

10. The sensor system of claim 9, wherein the valve is configured to impede fluid flow between the sample path and the calibration path when the sensor apparatus, including the sensor, is moved from its position in the sample path into the calibration fluid path.

11. The sensor system of claim 1, further comprising a flow control device configured to regulate flow of biological fluid within the sample path.

12. The sensor system of claim 11, wherein the sample path is further in fluid communication with an infusion fluid source comprising an infusion fluid.

13. The sensor system of claim 12, wherein the flow control device is further configured to regulate flow of infusion fluid within the sample path.

14. The sensor system of claim 13, wherein the flow control device comprises a flow regulating device selected from the group consisting of a valve, cam, and pump.

15. The sensor system of claim 14, wherein the valve is a pinch valve.

16. The sensor system of claim 14, wherein the pump is selected from the group consisting of a volumetric infusion pump, a peristaltic pump, a piston pump and a syringe pump.

17. The sensor system of claim 12, wherein the flow control device is operatively positioned between the sensor and the infusion fluid source.

18. The sensor system of claim 17, wherein the flow control device is selectively activatable to draw bodily fluid from the subject, along at least a portion of the sample path and into contact with the sensor when the sensor is positioned within the sample path.

19. The sensor system of claim 18, wherein the flow control device is selectively activateable to allow flow of infusion fluid through the sample path.

20. The sensor system of claim 18, wherein the sensor is a glucose sensor.

21. The sensor system of claim 20, wherein the bodily fluid is blood and where the glucose sensor is configured to sense glucose in the blood.

22. The sensor system of claim 1, wherein the sensor apparatus further comprises an actuator configured to move the sensor between the first configuration and the second configuration.

23. The sensor system of claim 22, wherein the actuator comprise a motor or a solenoid.

24. The sensor system of claim 22, further comprising at least one processing device in operative communication with the actuator and configured to implement activation of the actuator to move the sensor between its position in the calibration path and its position in the sample path.

25. The sensor system of claim 1, wherein the first fluid is a calibration fluid.

26. The sensor system of claim 25, wherein the calibration path is in fluid communication with a second fluid source that does not comprise calibrant.

27. The sensor system of claim 26, wherein the first fluid and the second fluid source are mixed in the calibration path.

28. The sensor system of claim 27, wherein the sensor is positioned in the mixed calibration fluid and second fluid source while in the first configuration.

29. The sensor system of claim 1, wherein the first fluid source comprises an anticoagulant.

30. A method for sensing one or more analytes in a bodily fluid, comprising:

positioning an analyte sensor in a first configuration wherein the analyte sensor is positioned in a sample path, the sample path configured in fluid communication with a bodily fluid of a subject, the bodily fluid comprising the one or more analytes;

drawing a volume of the bodily fluid into the sample path such that the analyte sensor contacts the bodily fluid and senses the one or more analytes; and

positioning the analyte sensor in a second configuration, wherein the analyte sensor is positioned in a calibration path, the calibrant path configured to receive a first fluid.

31. The method of claim 30, wherein the first fluid comprises at least one calibrant, the method further comprising calibrating the sensor by contacting the sensor while positioned in the calibration path with the first fluid.

32. The method of claim 30, wherein the first fluid comprises a flush solution, the method further comprising flushing the sensor by contacting the sensor while positioned in the calibration path with the first fluid.

33. The method of claim 30, wherein the sample path is physically isolated from the calibration path.

34. The method of claim 30, wherein the bodily fluid comprises blood.

35. The method of claim 30, wherein the first fluid comprises an anticoagulant.

36. The method of claim 30, further comprising providing an actuator, the actuator configured to position at least a portion of the at least one analyte sensor in the calibrant path in the first configuration, and to position at least a portion of the at least one analyte sensor in the sample path in the second configuration.