Disposable article having a biosensor

• US 6,713,660 B1
• Filed: 04/26/1999
• Issued: 03/30/2004
• Est. Priority Date: 06/29/1998
• Status: Expired due to Term

• Current Assignee: The Procter & Gamble Company
• Original Assignee: The Procter & Gamble Company
• Inventors: Roe, Donald C., Muscat, Andreas
• Primary Examiner(s): Dawson, Glenn K.
• Assistant Examiner(s): Stephens, Jacqueline F
• Application Number:
  US09/299,399
• Time in Patent Office: 1,800 Days
• Field of Search: 604/361, 604/385.01, 604/904, 604/359, 604/360, 604/367, 600/306, 600/345-350
• US Class Current: 604/361
• CPC Class Codes: A61F 13/42 with wetness indicator or alarm
• CPC Class Codes: A61F 13/495 with faecal cavity
• CPC Class Codes: A61F 13/82 with means for attaching to the body
• CPC Class Codes: A61F 13/84 Accessories, not otherwise provided for, for absorbent pads
• CPC Class Codes: A61F 2013/8473 for diagnostic purposes
• CPC Class Codes: A61F 2013/8479 including electric or magnetic devices
• CPC Class Codes: A61L 15/42 Use of materials characterised by their function or physical properties liquid bandages A61L26/00
• CPC Class Codes: A61L 15/56 Wetness-indicators or colourants
• CPC Class Codes: G01N 2333/59 Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: G01N 33/5308 for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/725 using peroxidative activity
• CPC Class Codes: G01N 33/84 involving inorganic compounds or pH
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

A disposable article to be fitted to a wearer comprising a biosensor including at least one bio-recognition element. The biosensor is adapted to detect a target biological analyte in bodily waste or on the wearer'"'"'s skin.

Claims

1. A disposable article to be fitted to a wearer comprising:

a biosensor including at least one bio-recognition element and a transducer, the biosensor being adapted to detect a target biological analyte in a bodily waste or on the wearers skin, wherein said bodily waste is selected from the group consisting of urine, feces, or menses.

2. The disposable article of claim 1 wherein the bio-recognition element comprises a biologically reactive agent.

3. The disposable article of claim 1 wherein the biosensor is selected from the group of:

a biocatalytic biosensor and a bioaffinity biosensor.

4. The disposable article of claim 3 wherein the bioaffinity biosensor is selected from the group of:

a chemoreceptor-based biosensor and an immunosensor.

5. The disposable article of claim 1 wherein the bio-recognition element is selected from the list including:

an enzyme or sequence of enzymes;

an antibody;

DNA;

an organelle;

a membrane receptor protein;

a natural or synthetic cell membrane;

viable or nonviable bacterial, plant, or animal cells;

at least a portion of a nerve bundle;

at least a portion of a sensing organ.

6. The disposable absorbent article of claim 5 wherein the bio-recognition element is selected from the group including Acinetobacter baumannii TOI36 and Bacillus sp TOI41.

7. The disposable absorbent article of claim 6 wherein the bio-recognition element is disposed on a substrate selected from the group of:

polymer based materials, hydrogels, tissues, nonwoven materials, and woven materials.

8. The disposable article of claim 1 wherein the biosensor detects target biological analytes selected from the following group:

pathogenic bacteria, colonic bacteria, viruses, parasites, bacterial toxins, fungi, enzymes.

9. The disposable article of claim 8 wherein the pathogenic bacteria is selected from the list:

Escherichia coli;

Salmonella typhi;

Salmonella paratyphi;

Salmonella enteriditis;

Salmonella typhimurium;

Salmonella heidelberg;

Shigella sonnei;

Shigella flexneri;

Shigella boydit;

Shigella dysenteriae;

Vibro cholera;

Mycobacterium tuberculosis;

Yer*69sinia enterocolitca;

Aeromonas hydrophila;

Plesiomonas shigelloides;

Campylobacteria jejuni;

Campylobacreria coli;

Bacteroides fragilis;

Clostridia septicum;

Clostridia perfingens;

Clostridia botulinum;

and Clostridia difficile.

10. The disposable article of claim 1 wherein the biosensor detects the target biological analyte associated with a systemic or skin health condition in the wearer prior to the onset of clinically observable symptoms of the condition.

11. The disposable article of claim 1 wherein the biosensor detects the target biological analyte only above a pre-defined threshold level.

12. The disposable article of claim 1 wherein the disposable article is chosen from the following group:

a sanitary napkin, a diaper, a training pant and an adult incontinence device.

13. The disposable article of claim 1 wherein the transducer is selected from the group including electrochemical, optical, thermal, and acoustic transducers.

14. The disposable article of claim 1 wherein the transducer signals only when target biological analyte is above a pre-defined threshold level.

15. The disposable article of claim 1 wherein the biosensor provides a signal to at least one of the group of:

the wearer, a caretaker, an actuator.

16. The disposable article of claim 15 wherein the signal is a visible indication.

17. The disposable article of claim 15 wherein the signal is qualitative.

18. The disposable article of claim 15 wherein the signal is quantitative.

19. The disposable article of claim 15 wherein the signal is durable throughout at least the usage life of the article.

20. The disposable article of claim 1 wherein the article additionally comprises a cleaning element for the biosensor.

21. The disposable article of claim 1 wherein the biosensor is affixed to a support element.

22. The disposable article of claim 21 wherein the support element is capable of adhesion to the wearer'"'"'s skin.

23. The disposable article of claim 21 wherein the support element is an adhesive tape.

24. The disposable article of claim 1 wherein the biosensor is detachable from the article.

25. The disposable article of claim 1 wherein the biosensor is capable of adhesion to the wearer'"'"'s skin.

26. The disposable article of claim 1 wherein the bodily waste is residual fecal contamination located on the wearer'"'"'s skin.

27. The disposable article of claim 1 further comprising an actuator that performs a responsive function when the biosensor detects a target biological analyte.

28. The disposable article of claim 27 wherein the responsive function is a signal to a caretaker, or the wearer.

29. The disposable article of claim 27 wherein the actuator transforms a potential energy to perform the responsive function, the potential energy being one or more selected from the group of:

mechanical energy, electrical energy and chemical energy.

30. The disposable article of claim 27 wherein the responsive function is one or more selected from the group of:

creating a void volume, treating skin, creating a foaming system and signaling a caregiver.

31. The disposable article of claim 1 wherein said biosensor is operatively connected to a portion of the disposable article that will be exposed to the target biological analyte.

32. The disposable article of claim 31 wherein said biosensor signals said operatively connected portion of the disposable article upon detection of the target biological analyte.

33. The disposable article of claim 31 further comprising a transmitter.

34. The disposable article of claim 33 wherein the transmitter comprises an infrared telemetry transmitter.

35. A disposable absorbent article to be fitted to a wearer comprising:

a topsheet;

a backsheet joined with the topsheet;

an absorbent core disposed between the topsheet and the backsheet; and

a biosensor disposed on the disposable article, the biosensor including at least one bio-recognition element and a transducer wherein the biosensor is adapted to detect a target biological analyte in bodily waste.

36. The disposable absorbent article of claim 35 further comprising an actuator that performs a responsive function when the biosensor detects a target biological analyte.

37. The disposable absorbent article of claim 36 wherein the responsive function is a signal to a caretaker, or the wearer.

38. The disposable article of claim 35 wherein the biosensor is capable of adhesion to the wearer'"'"'s skin.

39. The disposable absorbent article of claim 35 wherein the biosensor is detachable from the article.

40. The disposable absorbent article of claim 35 wherein the biosensor is operatively connected to a portion of the disposable article that will be exposed to the target biological analyte.

41. The disposable absorbent article of claim 35 wherein the disposable article is chosen from the following group:

a sanitary napkin, a diaper, a training pant and an adult incontinence device.

42. The disposable absorbent article of claim 35 wherein the bio-recognition element comprises a biologically reactive agent.

43. The disposable absorbent article of claim 35 wherein the biosensor is selected from the group of:

a biocatalytic biosensor and a bioaffinity biosensor.

44. The disposable absorbent article of claim 43 wherein the bioaffinity biosensor is selected from the group of:

a chemoreceptor-based biosensor and an immunosensor.

45. The disposable absorbent article of claim 35 wherein the bio-recognition element is selected from the list including:

an enzyme or sequence of enzymes;

an antibody;

DNA;

an organelle;

a membrane receptor protein;

a natural or synthetic cell membrane;

viable or nonviable bacterial, plant, or animal cells;

at least a portion of a nerve bundle;

at least a portion of a sensing organ.

46. The disposable absorbent article of claim 35 wherein the biosensor detects target biological analytes selected from the following group:

pathogenic bacteria, colonic bacteria, viruses, parasites, bacterial toxins, fungi, enzymes.

47. The disposable absorbent article of claim 46 wherein the pathogenic bacteria is selected from the list:

Escherichia coli;

Salmonella typhi;

Salmonella paratyphi;

Salmonella enteriditis;

Salmonella typhimurium;

Salmonella heidelberg;

Shigella sonnei;

Shigella flexneri;

Shigella boydii;

Shigella dysenteriae;

Vibrio cholerae;

Mycobacterium tuberculosis;

Yersinia enterocolitica;

Aeromonas hydrophila;

Plesiomonas shigelloides;

Campylobacter jejuni;

Campylobacter coli;

Bacteroides fragilis;

Clostridia septicum, Clostridia perfringens, Clostridia botulinum, and Clostridia difficile.