Oral fluid collection, transfer and transportation device and method

• US 8,025,849 B2
• Filed: 08/07/2003
• Issued: 09/27/2011
• Est. Priority Date: 08/14/2002
• Status: Active Grant

• Current Assignee: Cozart Bioscience Limited (Abbott Laboratories)
• Original Assignee: Cozart Bioscience
• Inventors: Jehanli, Ahmed, Baldwin, Dene, Hand, Christopher William
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): Turk; Neil
• Application Number:
  US10/636,888
• Publication Number:
  US 20040082878A1
• Time in Patent Office: 2,973 Days
• Field of Search: None
• US Class Current: 422/401
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2300/0609 Holders integrated in container to position an object
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: B01L 9/52 Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips

Abstract

An oral fluid collection and transfer device comprises a collection device (10) and a test cartridge (100). The collection device includes a frame or chassis (14), and an absorbing pad (12) for absorbing oral fluid and which is secured around part of the frame with part of the frame protruding from the pad. A collapsible cover (16) covers the absorbing means and has apertures (68) for the ingress of oral fluid into contact with the absorbing pad. A cap (18) covers the part of the frame protruding from the absorbing pad. The cap and the cover latch together to surround the frame and the absorbing pad. The device also includes a fluid adequacy indicator (20) in the form of an electrical circuit with an LED (66) which is completed when the absorbing means has absorbed a predetermined volume of oral fluid.

Claims

1. Apparatus for the collection and testing of oral, or other fluids, comprising a collection device and a test cartridge wherein:

the collection device comprises

(a) absorbing means for absorbing fluid,

(b) a collapsible cover within which the absorbing means is housed, and

(c) a fluid adequacy indicator in fluid communication with said absorbing means to receive said fluid absorbed by said absorbing means which said indicator detects the fluid absorbed by said absorbing means disposed in said collapsible cover for signaling when the absorbing means has absorbed a predetermined volume of fluid; and

the test cartridge comprises

(a) a collection chamber which allows insertion of the collection device into the test cartridge,

(b) a test strip in fluid communication with said collection chamber for testing fluid for the presence of analytes, and

(c) a locating structure which locates the collection device at a fixed location relative to the test cartridge within the collection chamber, in which location said collapsible cover is held in a compressed state by said locating structure such that the absorbing means has undergone a controlled degree of compression which transfers a predetermined volume of fluid from the absorbing means to the test strip.

2. Apparatus according to claim 1, wherein the collection device further comprises a plunger located above the absorbing means such that when the collection device is inserted into the test cartridge, the plunger applies a force to the absorbing means thereby at least partially compressing the absorbing means.

3. Apparatus according to claim 1, wherein the depth of the collection chamber is shorter than the uncompressed length of the collapsible cover such that the absorbing means cannot be fully inserted into the collection chamber without being at least partially compressed.

4. Apparatus according to claim 2, wherein the locating structure comprises a locking mechanism which defines the controlled degree of compression by said plunger, wherein said locking mechanism locates the collection device inside the test cartridge in a relative position such that the locking mechanism is activated only when the absorbing means is compressed by a predetermined amount by said plunger.

5. Apparatus according to claim 4, wherein the locking mechanism comprises:

a pair of flexible arms wherein the collection device comprises said flexible arms and an outwardly facing latch is positioned at the end of each of the flexible arms; and

a pair of corresponding locking holes situated in the test cartridge which correspond to the outwardly facing latches;

and wherein upon insertion of the collection device into the test cartridge, each of the latches is configured to engage a corresponding one of the locking holes when the absorbing means has been compressed by a predetermined amount to hold said collapsible cover in said compressed state.

6. Apparatus according to claim 5, wherein the locking mechanism is releasable.

7. Apparatus according to claim 1, wherein the absorbing means comprises a pad made of a cellulose or foam material.

8. Apparatus according to claim 1, wherein the absorbing means absorbs at least 0.6 ml of fluid.

9. Apparatus according to claim 1, wherein the collapsible cover is a deformable material which is durable and flexible to sustain chewing for collection of said fluid while said collapsible cover maintains an uncompressed state when not being chewed.

10. Apparatus according to claim 1, wherein the collapsible cover includes an odor or flavoring.

11. Apparatus according to claim 1, wherein the fluid adequacy indicator comprises an electronic circuit including a power source, a fluid sensitive contact and an alerting device.

12. Apparatus according to claim 11, wherein the alerting device is a buzzer.

13. Apparatus according to claim 11, wherein the alerting device is a light emitting device.

14. Apparatus according to claim 11, wherein the electronic circuit further comprises a timing device.

15. Apparatus according to claim 1, wherein the fluid adequacy indicator comprises a chemical based indicator.

16. Apparatus according to claim 15, wherein the fluid adequacy indicator comprises a wick comprising one of Porex™

, glass fibre and cellulose in which a fluid sensitive chemical dye is able to be hydrated by said fluid.

17. Apparatus according to claim 1, wherein the test cartridge further comprises markings which uniquely identifies the compatibility of the test strip.

18. Apparatus according to claim 1, wherein the test cartridge comprises a plurality of test strips, and wherein fluid is transferred from the collection device to each of the plurality of test strips.

19. Apparatus according to claim 18, wherein each of the plurality of test strips is able to test for a different analyte or multiple analytes.

20. Apparatus according to claim 1,

further comprising a transportation vial engagable with said collection device for transportation of a sample of fluid to a laboratory, wherein the transportation vial contains at least one sample vial for collection of fluid from said collection device, and comprises a neck portion which reclines said collapsible cover for insertion of the collection device into the transportation vial and means for locating the collection device at a fixed location relative to the transportation vial within the neck portion, in which location the absorbing means undergoes a controlled degree of compression thereby transferring a predetermined volume of fluid from the absorbing means to the at least one sample vial.

21. Apparatus according to claim 1, wherein:

the collapsible cover has apertures for the ingress of fluids, and the collection device further comprising;

a frame, having a first part contained within the collapsible cover and forming a compressor structure to compress the absorbing means, and a second part which protrudes from the upper end of the collapsible cover;

a cap for covering the second part of the frame protruding from the collapsible cover; and

engaging means for attaching the cap and the cover to surround the frame;

wherein compression of the collapsible cover causes the compressor structure to compress the absorbing means to force fluid absorbed by the absorbing means out of the absorbing means.

22. Apparatus according to claim 21, further comprising a transportation vial engagable with said collection device for transportation of a sample of fluid to a laboratory, wherein the transportation vial contains at least one sample vial for collection of fluid from said collection device, and comprises a neck portion which receives said collapsible cover for insertion of the collection device into the transportation vial and means for locating the collection device at a fixed location relative to the transportation vial within the neck portion, in which location the absorbing means undergoes a controlled degree of compression thereby transferring a predetermined volume of fluid from the absorbing means to the at least one sample vial.

23. Apparatus for the collection and testing of oral, or other fluids, comprising a collection device and a test cartridge which are selectively engagable together wherein:

the collection device comprises

(a) absorbing means for absorbing fluid,

(b) a collapsible cover within which the absorbing means is housed and enclosed, and

(c) a fluid adequacy indicator in fluid communication with said absorbing means to receive said fluid absorbed by said absorbing means, which said fluid adequacy indicator detects the absorbed fluid absorbed by said absorbing means disposed in said collapsible cover and signals externally of said collection device when the absorbing means has absorbed a predetermined volume of said absorbed fluid; and

the test cartridge comprises

(a) a collection chamber to allow insertion of the collection device into the test cartridge,

(b) a test strip wherein said test cartridge has said test strip positioned in fluid communication with said collection chamber for receiving said absorbed fluid from said collection device, and for testing said absorbed fluid for the presence of analytes; and

(c) a locating structure which locates the collection device at a fixed location relative to the test cartridge within the collection chamber, in which location said collapsible cover is held in a compressed state by said locating structure, in which said compressed state the absorbing means has undergone a controlled degree of compression to a compressed volume, which said compressed volume of said absorbing means expels a predetermined volume of said fluid from the absorbing means to the test strip.