Sensor

• US 9,797,909 B2
• Filed: 09/26/2016
• Issued: 10/24/2017
• Est. Priority Date: 03/15/2012
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Lightship Medical Limited
• Inventors: Paterson, William, Barwell, Nick, Culbert, Bruce, Crane, Barry Colin
• Primary Examiner(s): Wallenhorst, Maureen
• Application Number:
  US15/276,428
• Publication Number:
  US 20170010274A1
• Time in Patent Office: 393 Days
• Field of Search: 436 63, 436 95, 436127, 436135, 436 73, 436 84, 436164, 436165, 436166, 436174, 436178, 435 14, 4352887, 422 8205, 422 8207, 422 8208, 422 8211, 422534, 422535, 422 69
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• CPC Class Codes: G01N 21/7703 using reagent-clad optical fibres or optical waveguides using measurement of total internal reflection or attenuated total reflection G01N21/552; optical fibres or waveguides per se G02B
• CPC Class Codes: G01N 33/542 with steric inhibition or signal modification, e.g. fluorescent quenching
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G01N 33/84 involving inorganic compounds or pH
• CPC Class Codes: Y10T 436/144444 Glucose
• CPC Class Codes: Y10T 436/206664 Ozone or peroxide
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction

Abstract

A sensor for detecting and/or quantifying the amount of analyte in a sample, the sensor including:

• • a sensing region; and
  • a barrier layer including a reactive oxygen species (ROS)-quenching, analyte-permeable membrane having an ROS-quenching agent adsorbed thereto;
    wherein the sensor is adapted so that the sample enters the sensing region of the sensor through the barrier layer.

Claims

1. A sensor comprising:

a sensing region;

a porous barrier layer; and

a reactive oxygen species (ROS)-quenching agent formed on or in the barrier layer;

wherein the sensing region of the sensor defines one or more openings to allow an analyte in a bodily fluid sample to enter the sensing region;

wherein the barrier layer is disposed across the one or more openings to allow the analyte to enter the sensing region through the barrier layer such that the analyte comes into contact with the ROS-quenching agent;

wherein the barrier layer has an ROS-quenching activity sufficient to quench a solution of H₂O₂ having a concentration of 10 ppm; and

wherein the sensor is configured such that fluid passing through the barrier layer is in contact with the ROS-quenching agent throughout the time the fluid is moving through the barrier layer.

2. The sensor of claim 1, wherein the ROS-quenching agent comprises platinum.

3. The sensor of claim 2, wherein the ROS-quenching agent comprises platinum in the form of nanoparticles.

4. The sensor of claim 1, wherein an entire sensing region, or an entire surface of the sensor that comes into contact with the sample, is coated or sheathed with the barrier layer.

5. The sensor of claim 1, wherein the barrier layer comprises polypropylene hollow fibres.

6. The sensor of claim 1, wherein the sensing region is provided on a support material.

7. The sensor of claim 1, wherein the barrier layer is provided over the entire sensing region or is provided on only part of the sensing region.

8. A sensor comprising:

a sensing region; and

a porous barrier layer comprising an ROS-quenching agent;

wherein the sensing region of the sensor defines one or more openings to allow an analyte in a bodily fluid sample to enter the sensing region; and

wherein the barrier layer is disposed across the one or more openings to allow the analyte to enter the sensing region through the barrier layer such that the analyte comes into contact with the ROS-quenching agent;

wherein the barrier layer has an ROS-quenching activity sufficient to quench a solution of H₂O₂ having a concentration of at least 10 ppm; and

wherein the sensor is configured such that fluid passing through the barrier layer is in contact with the ROS-quenching agent throughout the time the fluid is moving through the barrier layer.

9. The sensor of claim 8, wherein the barrier layer is impregnated with the ROS-quenching agent.

10. The sensor of claim 8, wherein the barrier layer comprises platinum in the form of nanoparticles.

11. The sensor of claim 8, wherein the barrier layer is applied directly onto the sensing region.

12. The sensor of claim 8, wherein the barrier layer substantially does not cause depletion of analyte.

13. The sensor of claim 8, wherein sensing region comprises a receptor and a fluorophore that are bound to one another and to a polymeric matrix.

14. The sensor of claim 8, wherein the sensing region is provided on a support material.

15. The sensor of claim 8, wherein the barrier layer defines pores that have a pore size ranging from about 1 nm to 1 μ

m and an aspect ratio of at least 100.

16. The sensor of claim 8, wherein the barrier layer defines pores, the pores each having a length, and the ROS-quenching agent is within the pores of the barrier layer and is distributed along the length of the pores.

17. The sensor of claim 8, wherein the barrier layer is a layer formed by vapour deposition of the ROS-quenching agent.

18. The sensor of claim 8, wherein the barrier layer does not allow materials of molecular weight 6,000 or higher to pass through.

19. The sensor of claim 8, wherein the ROS-quenching agent is present at a loading of 0.01 to 5 wt % of the barrier layer.

20. The sensor of claim 8, wherein the barrier layer has an ROS-quenching activity sufficient to quench a solution of H₂O₂ having a concentration of 100 ppm.

21. The sensor of claim 8, wherein the barrier layer is provided over the entire sensing region or is provided on only part of the sensing region.

22. A sensor comprising:

a sensing region;

a porous barrier layer; and

an ROS-quenching agent formed on or in the barrier layer;

wherein the sensing region of the sensor defines one or more openings to allow an analyte in a bodily fluid sample to enter the sensing region;

wherein the barrier layer is disposed across the one or more openings to allow the analyte to enter the sensing region through the barrier layer such that the analyte comes into contact with the ROS-quenching agent; and

wherein the sensor is configured such that fluid passing through the barrier layer is in contact with the ROS-quenching agent throughout the time the fluid is moving through the barrier layer.