Self-Contained Test Sensor

• US 20080118399A1
• Filed: 12/12/2005
• Published: 05/22/2008
• Est. Priority Date: 12/13/2004
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Fleming, Roger
• Granted Patent: US 8,691,161 B2
• Time in Patent Office: Days
• US Class Current: 422/68.1
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2300/041 Connecting closures to device or container
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: C12Q 1/60 involving cholesterol
• CPC Class Codes: C12Q 1/61 involving triglycerides
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 35/00 Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor

Abstract

A test strip to assist in determining the concentration of an analyte in a fluid sample comprises a base, at least one tab and a break line. The base includes a capillary channel and a test element. The capillary channel is in fluid communication with the test element. The test element is adapted to receive the fluid sample. The at least one tab is removably attached to the base. The capillary channel extends from the base into a portion of the tab. The break line intersects the capillary channel in which an inlet to the capillary channel is exposed along the break line when the tab is separated from the base.

Claims

1. A test strip to assist in determining the concentration of an analyte in a fluid sample, comprising:

a base including a capillary channel and a test element, the capillary channel being in fluid communication with the test element, the test element being adapted to receive the fluid sample;

at least one tab removably attached to the base, the capillary channel extending from the base into a portion of the tab; and

a break line intersecting the capillary channel, wherein an inlet to the capillary channel is exposed along the break line when the tab is separated from the base.

2. The test strip of claim 1, further comprising at least one recess located between the base and the at least one tab, the at least one recess being adapted to facilitate the separation of the at least one tab from the base along the break line.

3. The test strip of claim 2, further comprising a second recess located between the base and the at least one tab opposite the at least one recess, the at least one recess and second recess facilitating the separation of the at least one tab from the base along the break line.

4. The test strip of claim 1, wherein the at least one tab includes a cavity having a desiccant located therein, the cavity being in gaseous communication with the capillary channel and the test element.

5. The test strip of claim 1, wherein the base includes a vent channel, the vent channel being in communication with the test element and the capillary channel.

9. The test strip of claim 5, wherein the break line intersects the vent channel.

11. The test strip of claim 5, further comprising a second tab removably attached to the base opposite the at least one tab, the vent channel extending from the base into the second tab.

13. The test strip of claim 1, further comprising a flexible strip removably attached to the base, the flexible strip at least partially separating from the base when the at least one tab is separated from the base, the flexible strip remaining attached to the at least one tab.

14. The test strip of claim 1, further comprising a notch adapted to facilitate the tearing of the at least one tab from the base along the break line.

19. The test strip of claim 1, wherein the test element contains a desiccant in gaseous communication with the test element.

20. The test strip of claim 1, wherein the test element contains a desiccant in liquid communication with the test element.

6-8. -8. (canceled)

10. (canceled)

12. (canceled)

15-18. -18. (canceled)

21. A method for using a test strip to determine a concentration of an analyte in a fluid sample, the method comprising the acts of:

providing a test strip including

(i) a base including a capillary channel and a test element, the capillary channel being in fluid communication with the test element, the test element being adapted to receive the fluid sample,

(ii) at least one tab removably attached to the base, the capillary channel extending from the base into a portion of the tab, and

(iii) a break line intersecting the capillary channel;

exposing an inlet to the capillary channel by at least partially separating the at least one tab from the base.

22. The method of claim 21, wherein an opening device is used to expose the inlet.

23. The method of claim 21, wherein the at least one tab is at least partially separated from the base by a meter.

24. The method of claim 21, wherein the at least one tab is at least partially separated from the base by twisting the at least one tab relative to the base.

25. The method of claim 21, wherein the at least one tab is at least partially separated from the base by tearing the test strip along the break line.

26. The method of claim 21, wherein the at least one tab is at least partially separated from the base by bending the test strip at the break line.

27. The method of claim 21, wherein the at least one tab is at least partially separated from the base by slicing the test strip at the break line.

28. The method of claim 21, wherein the at least one tab is at least partially separated from the base by pulling the at least one tab away from the base.

29. A test strip to assist in determining the concentration of an analyte in a fluid sample, comprising:

a base including a capillary channel and a test element, the capillary channel being in fluid communication with the test element, the test element being adapted to receive the fluid sample;

a tab removably attached to the base, the capillary channel extending from the base into a portion of the tab;

a protrusion extending from the base into the tab, the protrusion being an extension of the capillary channel into the tab; and

a break line intersecting the capillary channel, wherein an inlet to the capillary channel is exposed when the tab is separated from the base, the inlet being located at the end of the protrusion opposite the base.

30-38. -38. (canceled)

39. A test strip to assist in determining the concentration of an analyte in a fluid sample, comprising:

a base including an upper surface, a capillary channel, a test element, and a desiccant, the capillary channel being in fluid communication with the test element, the test element being adapted to receive the fluid sample; and

at least one tab removably attached to the upper surface of the base, the at least one tab including a lip that extends from the base, the lip being adapted to allow the at least one tab to be separated such that the separation from the base exposes an inlet to the capillary channel.

40-50. -50. (canceled)

51. A test strip to assist in determining the concentration of an analyte in a fluid sample, comprising:

a base including a capillary channel and a test element, the capillary channel being in fluid communication with the test element, the test element being adapted to receive the fluid sample; and

a tab having a body and at least one extension extending from the body of the tab, the at least one extension removably attaching the base to the tab,

wherein the at least one extension is adapted to separate from the base when the tab is rotated relative to the base.

52-57. -57. (canceled)

58. A test strip to assist in determining the concentration of an analyte in a fluid sample, comprising:

a base including a capillary channel and a test element, the capillary channel being in fluid communication with the test element, the test element being adapted to receive the fluid sample; and

at least one tab removably attached to the base, the at least one tab being located perpendicular to the base, the at least one tab being adapted to bend toward the base to expose an inlet to the capillary channel.

59-67. -67. (canceled)