Fluid collection and application device and methods of use of same

• US 7,114,403 B2
• Filed: 05/27/2004
• Issued: 10/03/2006
• Est. Priority Date: 05/30/2003
• Status: Active Grant

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Oakville Hong Kong Co., Limited
• Inventors: Dai, Jielin, Gao, Fei, Hu, Haipeng, Wu, Yuchang, Tung, Hsiaoho Edward, Guo, Huiyan
• Primary Examiner(s): RAEVIS, ROBERT R
• Application Number:
  US10/855,155
• Publication Number:
  US 20040237674A1
• Time in Patent Office: 859 Days
• Field of Search: 738/643.1, 738/645.1, 738/646.3, 738/647.1, 738/647.2, 738/649.1, 738/648.1, 600/573, 600/575, 600/580, 600/582, 604/1, 604/36, 604/37, 604/128, 604/290, 604/317, 604/358
• US Class Current: 73/864.72
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: B01L 3/0272 Dropper bottles
• CPC Class Codes: B01L 3/5029 using swabs

Abstract

The present invention is a device for conveniently collecting and storing liquid samples, as well as applying an aliquot of the sample to a test device, such as a lateral flow immunoassay. The present invention comprises an absorbent swab and a dropper container containing an expression means for expressing the collected sample from the swab. After the collected sample has been expressed into the reservoir of the device, the device is capped. The device can be inverted over a test device, the sides of the reservoir squeezed and an aliquot of the sample applied, in a drop-wise manner, to the sample application well of the test device. The present invention is particularly useful for collecting viscous samples, such as saliva or oral fluid, in a drug of abuse testing setting.

Claims

1. A device for collecting and storing a fluid, and applying an aliquot of the fluid to a test device, comprising:

a. a sample collector having an absorbent member, configured to collect a liquid sample;

b. a receiving member, configured to receive said sample collector;

c. an expression member, configured to express the collected sample from said absorbent member being manually pressed into the expression member;

d. a reservoir, configured to receive the expressed sample from said sample collector, wherein a portion of said reservoir is flexible, and;

e. an assembly fluidly connected to the reservoir and configured to expel the expressed sample from the device.

2. The device of claim 1, wherein said sample collector further comprises a handle and a handle attachment means, wherein said absorbent member is attached to said handle attachment means.

3. The device of claim 2, wherein said absorbent member further comprises a foam.

4. The device of claim 2, wherein said absorbent member further comprises a sponge.

5. The device of claim 2, wherein said absorbent member is treated with a solution that stimulates salivation in a subject from which the sample is to be collected.

6. The device of claim 2, wherein said handle is substantially rigid and optionally comprises a textured grip for holding said sample applicator.

7. The device of claim 1, said receiving member further comprising a barrel having first and second ends and an exterior and an interior, said first end further comprising an orifice providing access to said interior of said barrel for receiving said sample collector and said second end being attached to said reservoir.

8. The device of claim 7, the interior surface of said barrel interior having one or more longitudinal ribs.

9. The device of claim 7, said barrel second end further comprising an annular shoulder connecting to said reservoir.

10. The device of claim 7, said barrel second end further comprising a funnel connecting to said reservoir.

11. The device of claim 7, said first end of said barrel having first threads.

12. The device of claim 11, said assembly having second threads shaped to thread with said first threads of said barrel.

13. The device of claim 1, said expression means further comprising a ring having radial spokes against which said absorbent member is manually pressed and through which said sample flows into said reservoir.

14. The device of claim 1, said expression means further comprising a wall against which said absorbent member is manually pressed and said wall having an aperture in fluid communication with said reservoir and through which the sample flows to said reservoir.

15. The device of claim 1, said expression means further comprising a disk against which said absorbent member is manually pressed and said wall having one or more apertures in fluid communication with said reservoir and through which said sample flows to said reservoir.

16. The device of claim 1, said reservoir having flexible sides such that the sides of said reservoir can be manually pressed inward, whereby, when said device is in the inverted position, manually applied pressure on the reservoir causes expression of the sample from said assembly, in a drop-wise fashion.

17. The device of claim 1, wherein said reservoir is shaped like a squeeze bulb.

18. The device of claim 1, wherein said reservoir is cylindrically, lobularly, spherically, pear, tear-drop or box-like shaped.

19. The device of claim 1, wherein said assembly is configured to expel liquid as a stream, drops, droplets, or a mist.

20. The device of claim 7, said assembly being removably attached to the exterior surface of said first end of said barrel by a hinge member.

21. The device of claim 1, said assembly further comprising:

a lid having a dropper tip, said dropper tip having a mouth.

22. The device of claim 21, wherein said lid is adapted to tightly seal a first end of said receiving member.

23. The device of claim 1, said assembly further comprising a bottom that is snapably attachable to said receiving member and thereby closes said receiving member.

24. The device of claim 1, wherein said reservoir is adapted to allow for squeezing and when the device of claim 1 is in an inverted position said squeezing of said reservoir causes drops of the sample to be expelled from the device of claim 1 through said orifice of said dropper tip.

45. A method of collecting a fluid sample, using the device of claim 1 or 25, comprising:

a. providing the fluid sample;

b. contacting the fluid sample with said sample collector;

c. inserting said sample collector into said sample collector receiving member;

d. pressing said sample collector against said sample expression member, whereby the fluid sample is expressed from said sample collector;

e. removing said sample collector from said sample collector receiving member; and

f. closing said sample collector receiving member.

46. A method of applying a collected fluid sample to a test device, using the device of claim 1 or 25, comprising:

a. inverting the device of claim 1;

b. squeezing said sample reservoir; and

c. applying drops of the collected fluid sample to a test device.

47. A kit, comprising:

at least one device of claim 1 or 25 packaged together with instructions for use of said test device.

25. A device for collecting and storing a fluid, and applying an aliquot of the fluid to a test device, comprising:

a sample collector having a foam or sponge absorbent member, configured to collect a liquid sample;

a receiving member, configured to receive said sample collector and having therein an expression member against which said absorbent member is pressed;

a reservoir having flexible sides and that receives the expressed sample from said sample collector; and

an assembly fluidly connected to the reservoir and configured to expel the expressed sample from the device.

26. The device of claim 25, wherein said absorbent member is treated with a solution that stimulates salivation in a subject from which the sample is to be collected.

27. The device of claim 25, wherein said handle is substantially rigid and optionally comprises a textured grip for holding said sample applicator.

28. The device of claim 25, said receiving member further comprising a barrel having first and second ends and an exterior and an interior, said first end further comprising an orifice providing access to said interior of said barrel for receiving said sample collector and said second end being attached to said reservoir.

29. The device of claim 28, said first end of said barrel having first threads.

30. The device of claim 29, said assembly having second threads shaped to thread with said first threads of said barrel.

31. The device of claim 28, the interior surface of said barrel interior having one or more longitudinal ribs.

32. The device of claim 28, said barrel second end further comprising an annular shoulder connecting to said reservoir.

33. The device of claim 28, said barrel second end further comprising a funnel connecting to said reservoir.

34. The device of claim 25, said expression means further comprising a ring having radial spokes against which said absorbent member is manually pressed and through which said sample flows into said reservoir.

35. The device of claim 25, said expression means further comprising a wall against which said absorbent member is manually pressed and said wall having an aperture in fluid communication with said reservoir and through which the sample flows to said reservoir.

36. The device of claim 25, said expression means further comprising a disk against which said absorbent member is manually pressed and said wall having one or more apertures in fluid communication with said reservoir and through which said sample flows to said reservoir.

37. The device of claim 25, said reservoir having flexible sides such that the sides of said reservoir can be manually pressed inward, whereby, when said device is in the inverted position, manually applied pressure on the reservoir causes expression of the sample from said assembly, in a drop-wise fashion.

38. The device of claim 25, wherein said reservoir is shaped like a squeeze bulb.

39. The device of claim 25, wherein said reservoir is cylindrically, lobularly, spherically, pear, tear-drop or box-like shaped.

40. The device of claim 25, wherein said assembly is configured to expel liquid as a stream, drops, droplets, or a mist.

41. The device of claim 28, said assembly being removably attached to the exterior surface of said first end of said barrel by a hinge member.

42. The device of claim 25, said assembly further comprising:

a lid having a dropper tip, said dropper tip having a mouth.

43. The device of claim 42, wherein said lid is adapted to tightly seal a first end of said receiving member.

44. The device of claim 25, the assembly further comprising a bottom that is snapably attachable to said receiving member and thereby closes said receiving member.