Lateral flow device for attachment to an absorbent article

• US 9,895,094 B2
• Filed: 08/04/2014
• Issued: 02/20/2018
• Est. Priority Date: 04/30/2007
• Status: Active Grant

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Song, Xuedong
• Primary Examiner(s): Anderson, Lynne
• Application Number:
  US14/450,901
• Publication Number:
  US 20150025347A1
• Time in Patent Office: 1,296 Days
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 2010/0006 involving a colour change
• CPC Class Codes: A61B 5/207 Sensing devices adapted to collect urine
• CPC Class Codes: A61F 13/42 with wetness indicator or alarm
• CPC Class Codes: A61F 2013/8473 for diagnostic purposes
• CPC Class Codes: A61F 2013/8488 including testing apparatus
• CPC Class Codes: G01N 2800/348 Urinary tract infections
• CPC Class Codes: G01N 33/54306 Solid-phase reaction mechanisms
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387

Abstract

A lateral flow device for testing a bodily fluid, such as urine, blood, mucous, saliva, etc., is provided. The lateral flow device is configured to be attached to an absorbent article via an attachment mechanism located on the lateral flow device or the absorbent article. The lateral flow device includes a chromatographic medium (e.g., porous membrane) that defines a detection zone that provides a signal indicative of the presence or absence of the analyte. The device may also include a control zone that provides a signal indicative of whether a sufficient amount of bodily fluid has been provided and tested. Regardless of its specific configuration, the lateral flow device is configured to be attached onto the absorbent article to provide a user or caregiver with rapid information about a health condition. For example, the device may be attached onto a diaper to provide information about the presence of enzymes or other compounds often encountered with a patient having a urinary tract infection. This information may provide an early warning system to allow the user or caregiver to seek additional testing and/or treatment. Alternatively, semi-quantitative or quantitative results may be derived from the test.

Claims

1. An absorbent article for testing a bodily fluid suspected of containing an analyte, the absorbent article comprising:

an outer cover;

a bodyside liner;

an absorbent core positioned between the outer cover and the bodyside liner; and

an insert for testing the bodily fluid suspected of containing the analyte, the insert comprising a cover, a lateral flow device encased within the cover, and an attachment mechanism for attaching a liquid permeable back coversheet of the insert to the bodyside liner of the absorbent article, wherein the lateral flow device comprises a chromatographic medium that defines a detection zone, the detection zone being configured for exhibiting a signal indicative of the presence or absence of the analyte in the bodily fluid, wherein the lateral flow device is configured to perform a heterogeneous assay in which one species is separated from another species prior to detection, the lateral flow device further including a first absorbent area and a second absorbent area, the second absorbent area being positioned downstream to receive a bodily fluid after flowing through the chromatographic medium.

2. An absorbent article as in claim 1, wherein the liquid permeable back coversheet of the insert is releasably attached to the bodyside liner of the absorbent article.

3. An absorbent article as in claim 1, wherein the chromatographic medium includes a control zone for indicating that a sufficient volume of the bodily fluid has been received by the lateral flow device.

4. An absorbent article as in claim 3, wherein the lateral flow device further comprises a control reagent that is capable of being detected within the control zone.

5. An absorbent article as in claim 1, wherein the lateral flow device further comprises a sample application zone.

6. An absorbent article as in claim 1, wherein the lateral flow device further comprises a capture reagent that is substantially non-diffusively immobilized within the detection zone.

7. An absorbent article as in claim 6, wherein the capture reagent is a specific binding member.

8. An absorbent article as in claim 6, wherein the capture reagent is a diazonium ion or a derivative thereof.

9. An absorbent article as in claim 6, wherein the lateral flow device further comprises a diffusively immobilized reagent.

10. An absorbent article as in claim 9, wherein the diffusively immobilized reagent includes a specific binding member.

11. An absorbent article as in claim 9, wherein the diffusively immobilized reagent includes an aromatic ester substrate.

12. An absorbent article as in claim 1, wherein the liquid permeable back coversheet of the insert is adhesively attached to the bodyside liner of the absorbent article.

13. An absorbent article as in claim 1, wherein the liquid permeable back coversheet of the insert is attached to the absorbent article using a hook and loop type fastener.

14. An absorbent article as in claim 1, wherein the liquid permeable back coversheet of the insert comprises hook-like members for attaching to the bodyside liner of the absorbent article.

15. An absorbent article as in claim 1, wherein the liquid permeable back coversheet of the insert comprises an adhesive layer on an exposed surface for attaching to the bodyside liner.

16. An absorbent article as in claim 1, wherein the insert further comprises absorbent material configured to absorb less than 20% of the bodily fluid discharged into the absorbent article.

17. An absorbent article as in claim 16, wherein the insert is substantially superabsorbent free.

18. An absorbent article as in claim 1, wherein the insert comprises a transparent window allowing the detection zone to be viewed by a user.

19. An absorbent article as in claim 1, wherein detection zone of the lateral flow device is capable of being viewed when the absorbent article is worn by a wearer.

20. An absorbent article as in claim 19, wherein each of the outer cover, the absorbent core, and the bodyside liner comprises a transparent window, and wherein the outer cover, the absorbent core, the bodyside liner, and the lateral flow device are arranged such that the detection zone of the lateral flow device is viewable through the transparent window when the absorbent article is worn by a wearer.

21. The absorbent article of claim 1, wherein the analyte comprises a leukocyte esterase.

22. An insert for testing a bodily fluid suspected of containing an analyte, the insert comprising:

a cover;

a lateral flow device encased within the cover, the lateral flow device comprising a chromatographic medium that defines a detection zone, the detection zone being configured for exhibiting a signal indicative of the presence or absence of the analyte in the bodily fluid, wherein the lateral flow device is configured to perform a heterogeneous assay in which one species is separated from another species prior to detection, the lateral flow device further including a first absorbent area and a second absorbent area, the second absorbent area being positioned downstream to receive a bodily fluid after flowing through the chromatographic medium; and

an attachment mechanism configured to attach a liquid permeable back coversheet of the insert to a bodyside liner of an absorbent article.

23. The insert of claim 22, wherein the analyte comprises a leukocyte esterase.

24. A method for detecting the presence or absence of an analyte in urine, the method comprising:

attaching a liquid permeable back coversheet of an insert to a bodyside liner of an absorbent article, the insert comprising a cover and a lateral flow device encased within the cover, wherein the lateral flow device comprises a chromatographic medium that defines a detection zone, the detection zone being configured for exhibiting a signal indicative of the presence or absence of the analyte in the bodily fluid, wherein the liquid permeable back coversheet of the insert or the absorbent article comprises an attachment mechanism, wherein the lateral flow device is configured to perform a heterogeneous assay in which one species is separated from another species prior to detection, the lateral flow device further including a first absorbent area and a second absorbent area, the second absorbent area being positioned downstream to receive a bodily fluid after flowing through the chromatographic medium.

25. The method of claim 24, wherein the analyte comprises a leukocyte esterase.