SAMPLING AND TESTING DEVICE FOR THE HUMAN OR ANIMAL BODY

• US 20130096400A1
• Filed: 01/27/2011
• Published: 04/18/2013
• Est. Priority Date: 01/28/2010
• Status: Active Grant

• Current Assignee: Respirio Pty., Ltd.
• Original Assignee: Respirio Pty., Ltd.
• Inventors: Dahl, Steven David, Parsons, Sean Andrew, Maschmann, Jennifer, Wong, Kon Euan Gerard, Spink, Tim Ian, Wilson, Stephen Robert
• Granted Patent: US 9,877,672 B2
• Time in Patent Office: Days
• US Class Current: 600/317
• CPC Class Codes: A61B 10/0038 Devices for taking faeces samples; Faecal examination devices anal receptacles A61F5/451
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0048 for taking amniotic fluid samples
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 10/0058 for taking sperm samples artificial insemination A61B17/43; for animals A61D19/021; genital receptacles for the male member A61F5/453; massage of the genitals A61H19/00
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 2010/0003 including means for analysis by an unskilled person
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/15 Devices for taking samples of blood hypodermic syringes A61M5/178
• CPC Class Codes: A61B 5/207 Sensing devices adapted to collect urine
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis

Abstract

A device (1) is provided that is configured to indicate the presence or absence of one or more biological entities in a biological sample. The device comprises a sampling portion (11), the sampling portion comprising flexible material adjustably conformable to a part of a human or animal body, at least a portion of the sampling portion being absorbent and configured to receive a biological sample directly from the body; and a test portion (12) in fluid engagement with the sampling portion, the test portion comprising one or more test zones (14). The sampling portion and test portion are configured such that at least a portion of the sample received by the sampling portion is transferable to the test portion such as to contact one or more of the test zones, and wherein each test zone is configured to indicate the presence or absence of one or more biological entities in the sample.

Claims

1. A device comprising:

a substantially rigid housing;

a sampling portion located outside the housing, the sampling portion comprising flexible material adjustably conformable to a part of a human or animal body, at least a portion of the sampling portion being absorbent and configured to receive a biological sample directly from the body; and

a test portion located at least partially inside the housing and in fluid engagement with the sampling portion, the test portion comprising one or more test zones,

wherein the sampling portion and the test portion are configured such that at least a portion of the biological sample received by the sampling portion is transferable to the test portion by capillary action such as to contact one or more of the test zones, and wherein each of the one or more test zones is configured to indicate a presence or absence of one or more biological entities in the biological sample.

2. The device of claim 1, wherein the biological sample comprises any one or more of the following:

blood, serum, plasma, saliva, sputum, urine, ocular fluid, tears, semen, vaginal discharge, nasal secretions and droplets, ear secretions, perspiration, mucus, stool, and amniotic, spinal, wound, and abscess fluid.

3. The device of claim 1, wherein at least a portion of the sampling portion is conformable to a nasal region of the body to permit a nasal discharge sample to be provided directly to the sampling portion.

4. The device of claim 3, wherein at least a portion of the sampling portion is conformable to contact portions adjacent an ala or an alar groove of a nose and to extend across a tin of the nose.

5. The device of claim 1, wherein at least a portion of the sampling portion is conformable to an intergluteal cleft to permit a stool sample to be provided directly to the sampling portion.

6. The device of claim 1, wherein the device is at least partially a substantially flat, pliable device.

7. The device of claim 1, wherein the sampling portion comprises one or more flexible sheet elements.

8. The device of claim 1 comprising a test layer, wherein the sampling portion and the test portion are comprised in the test layer.

9. The device of claim 8, further comprising a cover layer attached to the test layer, the cover layer defining an opening through which the biological sample is deliverable to a target region of the sampling portion of the test layer.

10. The device of claim 9, wherein the cover layer acts as a barrier to prevent direct application of the biological sample to the test portion and/or regions other than the target region of the sampling portion.

11. The device of claim 8, further comprising a backing layer attached to the test layer.

12. The device of claim 11, wherein the backing layer is fluid resistant.

13. The device of claim 1 wherein the housing comprises one or more windows, to allow observation of a reaction at one or more of the test zones to indicate a presence or absence of one or more biological entities in the biological sample.

14. The device of claim 1 wherein the device is foldable such that, after deposition of the biological sample on the sampling portion, the biological sample can be enclosed by the device.

15. The device of claim 14 further comprising one or more fixation devices to maintain the device in a folded configuration.

16. The device of claim 1 further comprising a sealed reservoir, the reservoir containing a liquid releasable from the reservoir to increase fluidity of a deposited biological sample.

17. The device of claim 16, wherein the device is foldable such that, after deposition of the biological sample on the sampling portion, the biological sample can be enclosed by the device and wherein the reservoir is configured to release the liquid automatically during folding of the device.

18. The device of claim 16, wherein the device is foldable such that, after deposition of the biological sample on the sampling portion, the biological sample can be enclosed by the device and wherein the device is operable by a user to release the liquid from the reservoir after folding of the device.

20. The device of claim 16, wherein the reservoir is breakable or burstable to release the liquid.

23. The device of claim 16 wherein the reservoir is at least partially enclosed in the housing.

24. The device of claim 23, wherein the housing comprises an actuation mechanism operable to break or burst the reservoir to release the liquid.

25. The device of claim 1, wherein the test portion comprises a label-holding zone including a labelling substance configured to bind a fluorescent structure to a biological entity in the biological sample;

and the device further comprises one or more light sources operable to emit light at a wavelength suitable for causing the fluorescent structure to fluoresce.

26. The device of claim 25, wherein the one or more light sources are configured to backlight the one or more test zones.

27. The device of claim 25, wherein the housing comprises an actuation mechanism operable to break or burst the reservoir to release the liquid and wherein the actuation mechanism is also operable to cause illumination of one or more of the light sources.

28. The device of claim 1, wherein, upon indicating the presence of a biological entity, the device is configured to display a code or identifier that is unique to the biological entity and/or the device.

34. The device of claim 1, wherein the test portion comprises at least one lateral flow test strip.

35. The device of claim 1, wherein the sampling portion comprises two flexible wings, each wing extending from, and being pivotable relative to, the housing.

19. (canceled)

21. (canceled)

22. (canceled)

29. (canceled)

30. A device comprising:

a sampling portion for receiving a biological sample directly from a body;

a test portion in fluid engagement with the sampling portion, the test portion comprising one or more test zones; and

a sealed reservoir containing liquid,

wherein the sampling portion and the test portion are configured such that at least a portion of the biological sample received by the sampling portion is transferable to the test portion such as to contact one or more of the test zones, and wherein each of the one or more test zones is configured to indicate a presence or absence of one or more biological entities in the biological sample; and

wherein the sealed reservoir is configured such that the liquid is releasable from the reservoir to increase fluidity of the biological sample, and

wherein at least a portion of the biological sample received by the sampling portion is transferable to the test portion by capillary action.

31. (canceled)

32. (canceled)

33. (canceled)