Optical format with platform-and-well construction

• US 8,226,904 B2
• Filed: 10/29/2004
• Issued: 07/24/2012
• Est. Priority Date: 10/30/2003
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Dosmann, Andrew J.
• Primary Examiner(s): SAKELARIS, SALLY A
• Application Number:
  US10/576,993
• Publication Number:
  US 20070031960A1
• Time in Patent Office: 2,825 Days
• Field of Search: 422/55, 422/58, 422/68.1
• US Class Current: 422/402
• CPC Class Codes: B01L 2300/0887 Laminated structure
• 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 3/502723 characterised by venting arrangements
• CPC Class Codes: G01N 2021/0346 Capillary cells; Microcells
• CPC Class Codes: G01N 21/03 Cuvette constructions
• CPC Class Codes: Y10T 436/163333 Organic [e.g., chemical warfare agents, insecticides, etc.]

Abstract

Formats for optical analysis of fluid samples are provided with platforms and wells for contacting fluid samples and bringing reagents in contact with fluid samples. Formats may be made in opposing platform-and-well constructions, allowing a platform protruding from one format member to enter a well contained within an opposing format member. A sample fill nose accepts sample fluid from a sample collection opening and transports the sample fluid through the format.

Claims

1. A format for optical testing of a sample comprising:

a first format member comprising a first inner surface and a platform extending a distance from said inner surface;

a second format member comprising a second inner surface and a well disposed within said second inner surface, said well having a predetermined volume and shaped to accept said platform of said first format member within said well, said platform filling a significant portion of said predetermined volume such that said well and said platform define a sample testing region having a sample testing region volume significantly less than said predetermined volume and having a predetermined sample testing region height;

a sample fill nose disposed within said second format member and extending from a sample collection opening at a first end of said sample fill nose to intersect with said well at a second end of said sample fill nose; and

a vent disposed within said second format member and extending along said second inner surface from a vent opening at a first end of said vent to intersect with said well at a second end of said vent,

wherein said sample fill nose has a sample fill nose cross-section and said vent has a vent cross-section different from said sample fill nose cross-section, said vent configured to receive sample overfill from said sample testing region via said second end of said vent.

2. The format of claim 1 wherein said second end of said vent intersects with said well at an area approximately opposing the intersection of said second end of said sample fill nose with said well.

3. The format of claim 1 wherein said platform extends from said first inner surface to a platform height and wherein said well extends within said second format member to a well depth greater than said platform height, the difference of said well depth and said platform height defining said sample testing region height.

4. The format of claim 1 wherein said platform is provided with a reagent thereon for reacting with said sample.

5. The format of claim 3 wherein said sample fill nose has a fill a fill nose volume greater than said sample testing region volume.

19. The format of claim 1 wherein said vent cross-section has a first area and said sample fill nose cross-section has a second area, said first area is greater than said second area.

22. The format of claim 1 wherein said platform extends in a direction substantially perpendicular to said inner surface.

6. A format for optical testing of a sample comprising:

a first format member comprising a first inner surface and a platform extending to a platform height from said inner surface;

a second format member comprising a second inner surface and a well disposed within said second inner surface and extending a well depth below said second inner surface, said well having a first volume and shaped to accept said platform of said first format member within said well, said platform filling a significant portion of said first volume of said well thereby forming a sample testing region having a predetermined sampling volume that is significantly less than said first volume;

a sample fill nose extending from a sample collection opening at a first end of said sample fill nose to said well at a second end of said sample fill nose; and

a vent extending from a vent opening at a first end of said to said well at a second end of said vent,

wherein said sample fill nose has a sample fill nose cross-section and said vent has a vent cross-section different from said sample fill nose cross-section, said vent configured to receive sample overfill from said sample testing region via said second end of said vent.

7. The format of claim 6 wherein said platform is cylindrical and has a platform diameter and said well is cylindrical and has a well diameter greater than said platform diameter.

8. The format of claim 6 wherein said sample fill nose is adapted to transport a volume of said sample from said sample collection opening to said sample testing region via capillary action.

9. The format of claim 8 wherein said volume of said sample is approximately 50 nl.

10. The format of claim 8 wherein said volume of said sample is within the range of from approximately 5 nl to approximately 1000 nl.

11. The format of claim 7 wherein said vent opening is provided on an opposite side of said format from said sample collection opening.

20. The format of claim 8 wherein said vent cross-section has a first area and said sample fill nose cross-section has a second area, said first area is greater than said second area.

12. A method of manufacturing a format for optical testing, the method comprising the acts of:

providing a first format member comprising a first inner surface and a platform extending to a platform height above said first inner surface;

providing a second format member comprising;

a) a second inner surface and a well disposed within said second inner surface and extending to a well depth below said second inner surface, said well depth being greater than said platform height, said well having a first volume;

b) a sample fill nose notch having a first width, said sample fill nose notch terminating at said well; and

c) a vent notch having a second width different that said first width, said vent notch terminating at said well; and

joining said first format member to said second format member by inserting said platform of said first format member into said well of said second format member, said platform filling a significant portion of said first volume of said well thereby forming a sample testing region having a sample region volume that is significantly less than said first volume, wherein said vent notch is configured to receive sample overfill from said sample testing region.

13. The method of claim 12 further comprising applying a testing reagent to said platform.

14. The method of claim 12 wherein said sample fill nose notch approximately opposes said vent notch across said well.

15. The method of claim 12 further comprising providing adhesive on one or both of said first and second format members.

16. The method of claim 12 wherein said vent notch has a rectangular cross-section.

17. The method of claim 12 wherein said fill nose notch has a rectangular cross-section.

21. The method of claim 12 wherein said first width is greater than said second width.

18. A format for optical testing of a sample comprising:

a first format member comprising a first inner surface and a platform extending a distance from said inner surface in a direction substantially perpendicular to said inner surface;

a second format member comprising a second inner surface and a well disposed within said second inner surface, said well being shaped to accept said platform of said first format member within said well, said well and said platform defining a sample testing region having a first volume; and

a sample fill nose disposed within said second format member and extending from a sample collection opening at a first end of said sample fill nose to intersect with said well at a second end of said sample fill nose, said sample fill nose having a second volume approximately equal to said first volume.