Test strip with flared sample receiving chamber

• US 8,071,030 B2
• Filed: 06/18/2004
• Issued: 12/06/2011
• Est. Priority Date: 06/20/2003
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG), Roche Operations Limited (Roche Holding AG)
• Inventors: Bhullar, Raghbir S., Surridge, Nigel, Funke, Tom, Walling, Paul Douglas, Riggles, Randall K.
• Primary Examiner(s): Alexander, Lyle
• Application Number:
  US10/872,027
• Publication Number:
  US 20050019212A1
• Time in Patent Office: 2,727 Days
• Field of Search: 422/401, 422/412, 422/82.01, 204/403.01
• US Class Current: 422/82.01
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: Y10T 156/1052 with cutting, punching, tearing or severing

Abstract

A test strip with a sample receiving chamber having a novel flared portion that terminates in a sample receiving opening. The flared portion provides a reservoir from which sample fluid can be drawn into the capillary or sample receiving chamber. The wider opening provided by the present invention is easier to “target” with a sample fluid. In preferred embodiments, the hydrophilic reagent layer extends to the dosing end or side of the test strip and further promotes wicking of the sample into the sample receiving chamber and thus reduces dose hesitation. In other preferred embodiments, a tapered dosing end is provided on the test strip in combination with the flared portion, and this combination create a test strip that will draw sample fluid into the sample receiving chamber regardless of where along the dosing edge of the test strip the fluid sample makes contact.

Claims

1. A test strip for analyzing a fluid, comprising:

a test strip body defining a generally hollow interior sample receiving capillary chamber defined between interior lower and upper surfaces within the test strip body, the chamber having a flared portion terminating in a fluid receiving opening of the capillary chamber and an elongated portion extending inwardly from the flared portion, the elongated portion being defined by a first pair of opposing sidewalls, the flared portion being defined by a second pair of sidewalls that narrow in a direction from the fluid receiving opening toward the elongated portion, the fluid receiving opening having a width greater than the distance between the opposing first pair of sidewalls of the elongated portion, the test strip body defining a vent in communication with the capillary chamber, whereby air can escape from the vent as fluid is drawn into the capillary chamber; and

a testing area positioned in the elongated portion of the capillary chamber for analyzing the fluid;

the test strip body further including

a base substrate;

a covering layer overlying the base substrate; and

a spacing layer sandwiched between the base substrate and the covering layer, the spacing layer including a void that defines the first and second pairs of sidewalls of the capillary chamber between the base substrate and the covering layer, the base substrate and the covering layer including mutually-facing wall surfaces which comprise the interior lower and upper surfaces defining the capillary chamber.

2. The test strip of claim 1, wherein the flared portion is defined by a pair of curved opening walls.

3. The test strip of claim 1, wherein the vent is formed in the covering layer.

4. The test strip of claim 3, wherein the covering layer comprises two pieces separated by a gap which overlies the capillary chamber and defines the vent.

5. The test strip of claim 1, wherein the covering layer, the spacing layer and the base substrate are all substantially flat.

6. The test strip of claim 1, wherein the covering layer and the base substrate include substantially aligned edges that comprise a fluid receiving edge of the test strip at which the fluid receiving opening is disposed.

7. The test strip of claim 6, wherein the aligned edges are substantially straight.

8. The test strip of claim 1, and further including at least one electrode located in the elongated portion of the capillary chamber, and a reagent layer covering the at least one electrode.

9. The test strip of claim 1 which includes a reagent in the elongated portion of the capillary chamber.

10. The test strip of claim 9 in which the reagent is for testing the concentration of blood glucose.

11. The test strip of claim 1 in which the flared portion is between the upper and lower surfaces and provides a reservoir from which sample fluid can be drawn into the elongated portion of the capillary chamber.

12. A test strip for analyzing a fluid, comprising:

a test strip body defining an interior sample receiving capillary chamber defined between interior lower and upper surfaces within the test strip body, the capillary chamber defining and terminating in a fluid receiving opening,

the interior capillary chamber including a first portion defined by a first pair of opposing sidewalls extending between the interior lower and upper surfaces,

the interior capillary chamber further including a second pair of sidewalls that extend from the fluid receiving opening to the first portion, the second pair of sidewalls extending between the interior lower and upper surfaces, the space between the second pair of sidewalls being wider at the fluid receiving opening than at the first portion,

the test strip body defining a vent in communication with the capillary chamber, whereby air can escape from the vent as fluid moves into the interior capillary chamber; and

a testing area located in the first portion of the capillary chamber;

the test strip body further including

a base substrate;

a covering layer overlying the base substrate; and

a spacing layer sandwiched between the base substrate and the covering layer, the spacing layer including a void portion that defines the first and second pairs of sidewalls of the capillary chamber between the base substrate and the covering layer, the base substrate and the covering layer including mutually-facing wall surfaces which comprise the interior lower and upper surfaces defining the interior capillary chamber.

13. The test strip of claim 12, and further including at least one electrode located in the first portion of the capillary chamber, and a reagent covering the at least one electrode.

14. The test strip of claim 13 in which the reagent is for testing the concentration of an analyte in a liquid.

15. The test strip of claim 14 in which the reagent is for testing the concentration of blood glucose.

16. A test strip for analyzing a fluid, comprising:

a test strip body defining an interior sample receiving capillary chamber defined between interior lower and upper surfaces within the test strip body,

the capillary chamber defining and extending inwardly from a fluid receiving opening,

the capillary chamber including a test area location spaced inwardly from the fluid receiving opening,

the fluid receiving opening having a width, the capillary chamber having a width at the test area location, the width of the capillary chamber at the fluid receiving opening being greater than the width of the capillary chamber at the test area location,

the test strip body defining a vent in communication with the capillary chamber;

the test strip body further including

a base substrate;

a covering layer overlying the base substrate; and

a spacing layer sandwiched between the base substrate and the covering layer, the spacing layer including a void portion that defines sidewalls of the capillary chamber between the base substrate and the covering layer, the base substrate and the covering layer including mutually-facing wall surfaces which comprise the interior lower and upper surfaces defining the capillary chamber.

17. The test strip of claim 16 and which further includes a reagent at the test area location, the reagent being for testing the concentration of blood glucose.

18. The test strip of claim 16, and further including at least one electrode located at the test area location, and a reagent covering the at least one electrode.