Small volume and fast acting optical analyte sensor

• US 8,501,111 B2
• Filed: 04/14/2012
• Issued: 08/06/2013
• Est. Priority Date: 05/21/2009
• Status: Expired due to Fees

• Current Assignee: URIT Medical Electronic Group Co., Ltd.
• Original Assignee: URIT Medical Electronic Group Co., Ltd.
• Inventors: Xu, Tom Cheng
• Primary Examiner(s): COLE, MONIQUE T
• Application Number:
  US13/447,165
• Publication Number:
  US 20130102065A1
• Time in Patent Office: 479 Days
• Field of Search: 422/57, 422/400, 422/401, 422/408, 422/412, 422/68.1
• US Class Current: 422/412
• CPC Class Codes: C12Q 1/28 involving peroxidase
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: G01N 33/523 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/526 the element being adapted for a specific analyte

Abstract

A fast acting sensor designed to accommodate an aqueous analyte-containing sample having a volume of less than one microliter and that can be used to quantify the amount and concentration of such analyte in the sample through light reflectance or fiber-optic light reflectance. The sensor includes a storage chamber, a capillary passage, and a reaction membrane. The storage chamber acts to collect the sample and to secure such sample while it undergoes detection. The capillary passage acts to direct the sample over the reaction membrane and controls the diffusion of the sample in the storage chamber. The reaction membrane contains all of the chemicals and enzymes needed to cause a color-change reaction when contacted with the sample. The amount of analyte can be determined by light reflectance intensity with an optical measurement instrument.

Claims

1. A sensor for receiving, storing, and chemically reacting with fluid samples from a user for purposes of detecting and quantifying the amount of analytes in such samples by optical means using an optical measurement instrument, such a sensor comprising:

a base support member, such a base support member providing support for said sensor and having an aperture that allows a portion of a reaction membrane to be exposed to said optical measurement instrument;

said reaction membrane having a surface which is in physical contact with said base support member and covers all of said aperture, said reaction membrane comprising at least one reagent for reacting with at least one compositional component of said analytes and requiring no redox mediators for reaction;

a storage chamber comprising an open-ended capillary passage for conducting said sample from an incision laterally across the width of said storage chamber and simultaneously permitting said sample to saturate said reaction membrane without an additional sorbent material, wherein;

said storage chamber is attached directly to said base support member and said open-ended capillary passage is positioned directly over said reaction membrane;

the open ends of said capillary passage extends to the lateral edges of said base support member and permits saturation of said reaction membrane without an additional sorbent material;

the ventral side of said capillary passage is exposed entirely to said reaction membrane and the width of said capillary passage is no greater than the diameter of said aperture;

said capillary passage is configured to align said sample over an area of said reaction membrane in vertical alignment with said aperture; and

said capillary passage is sized to contain a volume of less than about 1 μ

L of said sample and where the open ends of said capillary passage prevents uncontrolled diffusion of said sample into said storage chamber; and

whereby said sensor is used to measure the amount of analytes in such fluid samples without the use of electrodes on said sensor.

2. The sensor of claim 1, wherein said capillary passage is sized to contain a volume of less than about 0.5 μ

L of said sample and where the open ends of said capillary passage prevents uncontrolled diffusion of said sample into said storage chamber.

3. The sensor of claim 1, wherein said capillary passage is sized to contain a volume of less than about 0.1 μ

L of said sample and where the open ends of said capillary passage prevents uncontrolled diffusion of said sample into said storage chamber.

4. The sensor of claim 1, wherein said aperture has a surface area no greater than approximately 1.0 mm².

5. The sensor of claim 1, wherein said base support member comprises multiple inert and non-conductive circular and half-circular cutouts made directly on said base support member as means for engagement with said optical measurement instrument from either the right or left side of said sensor.

6. The sensor of claim 5, wherein said multiple cutouts are circular bores with a surface area no greater than 1 mm² and said multiple half-circular cutouts are half-circular bores located at the edges of said base support member as means for engagement with said optical measurement instrument.

7. The sensor of claim 1, wherein the top of said storage chamber is comprised of a transparent material for ease of viewing by said user.

8. The sensor of claim 1, wherein said reaction membrane comprises a hydrophilic material.