Formats for optical analysis and methods of manufacturing the same

• US 7,494,620 B2
• Filed: 10/29/2004
• Issued: 02/24/2009
• 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:
  US10/576,992
• Publication Number:
  US 20070031975A1
• Time in Patent Office: 1,579 Days
• Field of Search: 436/165, 436/86, 350/536, 422/58, 600/317
• US Class Current: 422/561
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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 at least one first format component pin, at least one first format component hole, a first inlet surface, and a first read surface; and

a second format component having at least one second format component pin, at least one second format component hole, a second inlet surface, and a second read surface, said at least one first format component pin being inserted into said at least one second format component hole and said at least one second format component pin being inserted into said at least one first 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 fill capillary gap,

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 at least one first format component pin and said at least one second format component hole meeting at least one first pin-hole meeting interface and said at least one second format component pin and said at least one first format component hole meeting at least one second pin-hole meeting interface, each of said first and second pin-hole interfaces being joined with adhesive, with substantially no adhesive being provided between said first format component inner surface and said second format component inner surface.

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

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

a second format component having at least one second format component pin, at least one second format component hole, a second inlet surface, and a second read surface, said at least one first format component pin being inserted into said at least one second format component hole and said at least one second format component pin being inserted into said at least one first 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 fill capillary gap,

wherein said first format component comprises first and second slots disposed on first and second side surfaces of said first format component.

3. The format of claim 2 wherein said second format component comprises third and fourth slots disposed on third and fourth side surfaces of said second format component.

4. 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 fill capillary gap 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;

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

applying adhesive to at least one of said first format component pin, said first format component hole, said second format component pin and said second format component hole.

5. 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 fill capillary gap 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,

wherein at least one of forming said first format component and forming said second format component comprises molding slots into said at least one component and molding the format component between first and second ribbons.

6. 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 fill capillary gap 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

wherein at least one of forming said first format component and said second format component comprises forming said component as part of a chain of format components.

7. 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 comprises first and second slots disposed on first and second side surfaces of said first format component, 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, and said first read surface and said second read surface align to form a read area.

8. The format of claim 7 wherein said second format component comprises third and fourth slots disposed on third and fourth side surfaces of said second format component.

9. A format for the optical analysis of a sample 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, said first read surface and said second read surface align to form a read area, and said at least one first format component pin is adhesively attached to said at least one second format component hole.