Formats for optical analysis and methods of manufacturing the same

• US 7,731,897 B2
• Filed: 10/15/2008
• Issued: 06/08/2010
• Est. Priority Date: 10/30/2003
• Status: Expired due to Fees

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Brenneman, Allen J.
• Primary Examiner(s): Griffin; Walter D
• Assistant Examiner(s): Mui; Christine T
• Application Number:
  US12/252,133
• Publication Number:
  US 20090040515A1
• Time in Patent Office: 601 Days
• Field of Search: 422/58, 422/55, 422/50, 436/165, 436/86, 356/246, 356/244, 294/64, 294/66, 294/28, 295/92
• US Class Current: 422/561
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/12 Specific details about manufacturing devices
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• 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: G01N 2021/0321 One time use cells, e.g. integrally moulded
• CPC Class Codes: G01N 2021/0346 Capillary cells; Microcells
• CPC Class Codes: G01N 2021/0378 Shapes
• CPC Class Codes: G01N 21/03 Cuvette constructions
• CPC Class Codes: G01N 21/51 inside a container, e.g. in an ampoule G01N21/53 takes precedence
• CPC Class Codes: Y10T 29/49895 Associating parts by use of aligning means [e.g., use of a drift pin or a "fixture"]
• CPC Class Codes: Y10T 29/49899 by multiple cooperating aligning means
• CPC Class Codes: Y10T 436/207497 Molecular oxygen

Abstract

Formats for the optical testing of fluids are manufacturing using modular format components. The format components are constructed so that matching format components can be mated together to form a single format for optical testing. Formats may be manufactured using pin-and-hole construction so that pins on optical format components mate with holes on opposing format components. Optical read surfaces provided on optical format components oppose each other in a completed optical format to form a read area.

Claims

1. A format for the optical analysis of a sample, said format comprising:

a first format component having a first format component pin, a first inlet surface, and a first read surface; and

a second format component forming a second format component hole, a second inlet surface, and a second read surface,

wherein said first format component pin is inserted into said second format component hole such that said first read surface and said second read surface align to form a read area and said first inlet surface and said second inlet surface align to form a capillary gap that is open on a plurality of sides.

2. The format of claim 1, wherein said first read surface and said first inlet surface are disposed within a first format component cavity and said second read surface and said second inlet surface are disposed within a second format component cavity.

3. The format of claim 1, wherein said first and second format components are optically clear, said first format component comprises a first format component inner surface and a first format component outer surface and said second format component comprises a second format component inner surface and a second format component outer surface, said first format component having a first optical window disposed on said first format component outer surface and approximately aligned with said first read surface, and said second format component having a second optical window disposed on said second format component outer surface and approximately aligned with said second read surface, said first optical window, said read area, and said second optical window aligning to form an optical path.

4. The format of claim 1, wherein said second format component is approximately identical to said first format component.

5. The format of claim 1, wherein said first format component comprises a first format component inner surface and said second format component comprises a second format component inner surface, said first format component pin and said second format component hole meet at a pin-hole meeting interface, said pin-hole interfaces being joined with a sonic weld.

6. The format of claim 1, wherein said first format component is optically clear and comprises a read window aligned with said first read surface.

7. The format of claim 1, wherein said first format component comprises a first inner format surface, said second component comprises a second inner format surface, and said first and second format components are held together via friction between aligning pairs of said holes and pins forming an interface between said first inner format surface and said second inner format surface, such that said first inner format surface and said second inner format surface abut one another substantially completely, said interface between said first inner format surface and said second inner format surface being substantially free of adhesive or other intervening material.

8. The format of claim 1, wherein a reagent is applied to at least one of said first read surface and said second read surface.

9. A method of forming a format for the optical analysis of a sample, said method comprising:

forming a first format component comprising a first format component pin, a first format component hole, a first inlet surface, and a first read surface;

forming a second format component comprising a second format component pin, a second format component hole a second inlet surface, and a second read surface;

aligning said first and second format components such that said first inlet surface is approximately aligned with said second inlet surface to form a capillary gap that is open on a plurality of sides and said first read surface is approximately aligned with said second read surface;

inserting said first format component pin into said second format component hole; and

inserting said second format component pin into said first format component hole.

10. The method of claim 9 further comprising sonically welding at least one of said first and second component pins to its corresponding format component hole.

11. The method of claim 9 further comprising applying a reagent to at least one of said first read surface and said second read surface.

12. The method of claim 9, wherein said first format component is optically clear and further comprises a read window approximately aligned with said first read surface.

13. The method of claim 9, wherein said first and second format components are optically clear and wherein said first format component comprises a first read window approximately aligned with said first read surface and said second format component comprises a second read window approximately aligned with said second read surface.

14. A format for the optical analysis of a sample, said format comprising:

a first format component having at least one first format component pin, a first format component inner surface, a first inlet surface, and a first read surface; and

a second format component having at least one second format component hole, a second format component inner surface, a second inlet surface, and a second read surface,

wherein said first format component pin is inserted into said second format component hole, said first format component inner surface and said second format component inner surface abut at an inner surface interface, said second inlet surface and said first inlet surface align to form a fill capillary gap that is open on multiple sides, and said first read surface and said second read surface align to form a read area.

15. The format of claim 14, wherein said first format component inner surface and said second format component inner surface abut each other substantially completely and said inner surface interface is substantially free of adhesive or other intervening material.

16. The format of claim 14, wherein said first read surface and said first inlet surface are disposed within a first format component cavity and said second read surface and said second inlet surface are disposed within a second format component cavity.

17. The format of claim 14, wherein said first and second format components are optically clear, said first format component further comprises a first format component outer surface and said second format component further comprises a second format component outer surface, said first format component having a first optical window disposed on said first format component outer surface and approximately aligned with said first read surface, and said second format component having a second optical window disposed on said second format component outer surface and approximately aligned with said second read surface, said first optical window, said read area, and said second optical window aligning to form an optical path.

18. The format of claim 14, wherein said at least one first format component pin is sonically welded into said at lease one second format component hole.

19. The format of claim 14 further comprising a reagent applied to at least one of said first read surface and said second read surface.