Minimally invasive sensor

• US 5,859,937 A
• Filed: 04/04/1997
• Issued: 01/12/1999
• Est. Priority Date: 04/04/1997
• Status: Expired due to Term

• Current Assignee: Light Pointe Medical Inc
• Original Assignee: NeoMecs, Inc.
• Inventors: Nomura, Hiroshi
• Primary Examiner(s): Lee, John D.
• Application Number:
  US08/832,941
• Time in Patent Office: 648 Days
• Field of Search: 385/12, 385/13, 385/31, 385/123, 385/15
• US Class Current: 385/12
• 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 33/54373 involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings
• CPC Class Codes: G02B 6/02309 Structures extending perpendicularly or at a large angle to the longitudinal axis of the fibre, e.g. photonic band gap along fibre axis

Abstract

A minimally invasive sensing device, and method for its use, is disclosed which utilizes a light-conducting fiber having a localized textured site thereon, wherein a reagent is deposited. Interaction of the reagent with an analyte specific to the reagent produces a response, such as development of a colored product, which is detectable by means of a change in characteristics of a light beam transmittable through the fiber. By means of the textured site and its increased surface area, the sensitivity of the device is greatly enhanced, such that less than 5 microliters of a fluid is needed for an analysis. The sensor is particularly useful in blood glucose determinations, requiring smaller blood samples than flat strip devices.

Claims

1. A sensor comprising a solid light-conducting fiber having a textured surface site consisting of a textured periphery prepared by atomic oxygen etching and an analyte-responsive reagent deposited on the fiber at said site, said reagent producing a physical or chemical response upon being contacted with said analyte contained within a fluid, said response being observable by a change in characteristics of a light beam transmittable through the fiber.

2. The sensor according to claim 1 wherein said textured site is fully wetted by contact with a droplet of a fluid, said droplet having an initial sampling volume of less than 5 microliters.

3. The sensor according to claim 2 wherein said textured site is adjacent an end of said fiber.

4. The sensor according to claim 3 wherein said textured site is fully wetted by contact with a droplet of a fluid, said droplet having an initial sampling volume in the range of 1 to 2.5 microliters.

5. The sensor according to claim 4 wherein said response comprises generation of a colored species by interaction of said reagent with said analyte.

6. The sensor according to claim 1 wherein said response comprises generation of a colored species by interaction of said reagent with said analyte.

7. A device comprising a light source, a light detector, and a solid light-conducting fiber having first and second ends, said fiber having a textured surface site consisting of a textured periphery prepared by atomic oxygen etching and an analyte-responsive reagent deposited on the fiber at said site, said reagent producing a physical or chemical response upon being contacted with a droplet of a fluid containing said analyte, said droplet having an initial sampling volume of less than 5 microliters, said response being observable by a change in characteristics of a light beam transmittable through the fiber from said light source to said detector.

8. The device according to claim 7 wherein said light source and said detector are located adjacent the first end of said fiber, and a portion of a light beam transmitted into said fiber from said light source is reflected from the second end of said fiber back toward said detector.

9. The device according to claim 8 wherein said textured site is adjacent the end of said fiber nearest the detector.

10. The device according to claim 7 wherein said light source and said detector are located at opposite ends of said fiber, and a portion of a light beam transmitted into said fiber from said light source is observable from said detector.

11. The device according to claim 10 wherein said textured site is adjacent either end of said fiber.

12. The device according to claim 10 wherein said detector is adjacent the first end of said fiber, the textured site is adjacent the second end of said fiber, and the light source comprises a chemiluminescence or fluorescence associated with interaction between said reagent and said analyte.

13. A method of analyzing for an analyte in a fluid comprising bringing a droplet of the fluid having an initial sampling volume of less than 5 microliters into contact with a light-conducting fiber having a textured surface site thereon consisting of a textured periphery prepared by atomic oxygen etching and an analyte-responsive reagent deposited on said fiber at said site, producing a physical or chemical response by interaction of said reagent with said analyte, said response being detectable by a change in characteristics of a light beam, transmitting a light beam through said fiber past said textured site from a light source, and analyzing said light beam for said change, said change being correlative with presence of said analyte in the fluid.

14. The method according to claim 13 wherein said change is correlative with the concentration of said analyte in the fluid.

15. The method according to claim 14 wherein the fluid being brought into contact with said fiber has an initial sampling volume of 1 to 2.5 microliters.

16. The method according to claim 15 wherein the fluid is blood and the analyte is glucose.