Hinged cap for diagnostic device

• US 9,168,526 B2
• Filed: 06/18/2010
• Issued: 10/27/2015
• Est. Priority Date: 06/19/2009
• Status: Active Grant

• Current Assignee: ZBx Corporation (NOWDiagnostics, Inc.)
• Original Assignee: ZBx Corporation (NOWDiagnostics, Inc.)
• Inventors: Shi, Qinwei, Eckhardt, Florian
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): Handy, Dwayne K
• Application Number:
  US12/818,297
• Publication Number:
  US 20100323433A1
• Time in Patent Office: 1,957 Days
• Field of Search: 422/405, 422/420, 422/550
• US Class Current: 1/1
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2300/043 Hinged closures
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces

Abstract

A hinged cap for engaging a housing of a diagnostic device comprises a central body; two arms extending from opposing sides of one end of said central body, said arms being substantially parallel; each of said arms comprising a cap hinge member for engaging a housing hinge member on said housing, wherein said cap hinge member and said housing hinge member define a hinge axis around which said cap is pivotable between an open and a closed position with respect to said housing.

Claims

1. A diagnostic device for assaying a biological sample, the diagnostic device comprising:

a housing; and

a hinged cap for engaging the housing, the hinged cap comprising;

a central body;

two arms extending from opposing sides of one end of said central body, said arms being substantially parallel;

each of said arms comprising a cap hinge member for engaging a corresponding housing hinge member on said housing,

wherein said cap and housing hinge members define a hinge axis around which said cap is pivotable in order between a first open position, a closed position and a second open position different from said first open position and beyond said closed position with respect to said housing;

the housing defining a sample flow channel with an opening at a proximal end of said housing, wherein said opening is protected by said cap when said cap is in the closed position and said opening is exposed when said cap is in the first or second open position, said housing further comprising a diagnostic membrane in fluid communication with said sample flow channel.

2. The diagnostic device of claim 1, wherein said arms are flexible.

3. The diagnostic device of claim 1, wherein said arms are tapered.

4. The diagnostic device of claim 1, wherein at least one of said arms comprises a cap lock member for releasably engaging a corresponding housing lock member on said housing to form a lock that maintains said cap in the closed position.

5. The diagnostic device of claim 4, wherein the cap lock member is a protuberance and the housing lock member is a groove.

6. The diagnostic device of claim 4, wherein the cap lock member is a groove and the housing lock member is a protuberance.

7. The diagnostic device of claim 1, further comprising a stop extending from said end of said central body between said arms for contacting a point on said housing and preventing said cap from pivoting beyond said closed position to said second open position.

8. The diagnostic device of claim 1, wherein said central body comprises a sloping surface and side walls that cooperate to form a sample transfer device guide channel, said channel terminating at a point on said end of said central body between said arms.

9. The diagnostic device of claim 8, wherein said guide channel aligns with an indent in the housing when the cap is in the closed position.

10. The diagnostic device of claim 1, wherein the cap hinge member is a post and the housing hinge member is an aperture.

11. The diagnostic device of claim 1, wherein the cap hinge member is an aperture and the housing hinge member is a post.

12. The diagnostic device of claim 1, wherein said housing has a proximal end for engaging said cap, a distal end, and a midpoint thereinbetween, said hinge axis being located between said midpoint and said proximal end.

13. The diagnostic device of claim 12, wherein the proximal end of said housing is tapered.

14. The diagnostic device of claim 13, wherein said housing has a viewing window between said proximal end and said distal end, said hinge axis being located between said viewing window and said proximal end.

15. The diagnostic device of claim 1, wherein said central body comprises a gripping surface and/or writing surface.

16. The diagnostic device of claim 1, wherein said cap is transparent.

17. The diagnostic device of claim 1, wherein said housing is provided with an upper half and a lower half that attach to one another to enclose said membrane.

18. The diagnostic device of claim 1, wherein said membrane is a lateral flow membrane.

19. The diagnostic device of claim 18, wherein said membrane is an enzymatic detection membrane or an immunodetection membrane.

20. The diagnostic device of claim 1, wherein said sample is selected from the group consisting of whole blood, serum, plasma, urine, saliva, sweat, spinal fluid, lacrimal fluid, vaginal fluid, semen, tissue lysate and combinations thereof.

21. The diagnostic device of claim 20, wherein said sample is whole blood.

22. The diagnostic device of claim 1, wherein said sample is provided in a volume of about 50 μ

l or less or 20 μ

l or less.

23. The diagnostic device of claim 1, wherein said device is transparent.

24. The diagnostic device of claim 1, wherein said arms and said central body are planar with respect to one another.

25. A diagnostic device comprising:

a diagnostic membrane;

a housing enclosing the diagnostic membrane, the housing defining a sample flow channel with an opening in a proximal end of said housing for applying a biological sample to the membrane and comprising two housing hinge members disposed on opposing sides of the housing; and

a cap for engaging the housing, the cap comprising a central body, two flexible arms extending from opposing sides of one end of said central body, said arms being substantially parallel, each of said arms comprising a cap hinge member for engaging one of said housing hinge members on said housing;

wherein said cap hinge members and said housing hinge members define a hinge axis around which said cap is pivotable in order between a first open position, a closed position and a second open position different from said first open position and beyond said closed position with respect to said housing.

26. The device of claim 25, wherein said opening is protected by said cap when said cap is in the closed position and said opening is exposed when said cap is in the open position.

27. The device of claim 25, wherein said housing is provided with an upper half and a lower half that attach to one another to enclose a membrane that is in fluid communication with said sample flow channel.

28. The device of claim 25, wherein said membrane is a lateral flow membrane.

29. The device of claim 28, wherein said membrane is an enzymatic detection membrane or an immunodetection membrane.

30. The device of claim 25, wherein said sample is selected from the group consisting of whole blood, serum, plasma, urine, saliva, sweat, spinal fluid, lacrimal fluid, vaginal fluid, semen, tissue lysate and combinations thereof.

31. The device of claim 30, wherein said sample is whole blood.

32. The device of claim 25, wherein said sample is provided in a volume of about 50 μ

l or less or about 20 μ

l or less.

33. The device of claim 25, wherein said device is transparent.

34. The device of claim 25, wherein said arms and said central body are planar with respect to one another.