MXPA01010948A

MXPA01010948A - Disposable articles and other articles comprising a detection device.

Info

Publication number: MXPA01010948A
Application number: MXPA01010948A
Authority: MX
Inventors: Donna R Hill
Original assignee: Procter & Gamble
Priority date: 1999-04-26
Filing date: 2000-04-26
Publication date: 2002-05-06
Also published as: AU4802900A; AU4803000A; EP1173758A2; CA2367588A1; WO2000065084A3; JP2002542843A; JP2002543397A; CA2370936A1; EP1173606A2; JP2002542846A; JP2002542845A; CA2370502A1; MXPA01010949A; CN1348501A; WO2000065083A2; CA2370509A1; EP1173618A1; WO2000065347A2; WO2000065347A9; MXPA01010946A

Abstract

A disposable article to be fitted to a wearer and other types of articles having a detection device, such as a diagnostic panel that may, in one set of embodiments, include at least one biosensor, each including at least one bio-recognition element. The biosensor is adapted to detect a target biological analyte in body substances, and on/or through the wearer's skin. The diagnostic panel may be adapted to determine the physical condition or state of well being of a mammal, or the cause of a particular disease state, such as diarrhea, vaginal infections, sexually transmitted diseases ("STD's"), and other diseases, and to signal the caretaker, the wearer, or an actuator of the occurrence. Examples of physical conditions of the state of well being include, but are not limited to, ovulation and the onset of menstruation.

Description

DISPOSABLE ITEMS AND OTHER ITEMS THAT COMPRISE A DETECTOR DEVICE FIELD OF THE INVENTION The present invention relates to disposable articles and other types of articles having a sensing device, such as a diagnostic panel that can, in a set of embodiments, include biosensors having a biorecognition element that detects microorganisms and / or other biomolecules present in the mammalian body, and more particularly an article that detects microorganisms and / or other biomolecules that may be present in body substances and / or through the skin. The present invention also relates to other types of detector devices and methods for using same.

BACKGROUND OF THE INVENTION Currently, disposable items, such as diapers, adult incontinence briefs, sanitary napkins, and tampons, are widely used for daily purposes and in the care of infants and toddlers and in the care of incontinent adults or menstruation. as means of containment, isolation and disposal of bodily waste. These items have generally been replaced by washable garments, reusable as the preferred means for those applications due to its convenience and applicability. Disposable items respond to a defecation, urination or discharge event by absorbing or containing the bodily wastes contained in the articles. Some items also indicate a defecation, urination or discharge event after it has occurred (eg humidity indicators, temperature change detection). Other disposable articles known in the art comprise chemical relative means for detecting various substances in the waste of the user. However, none 10 of these specifically detect potentially pathogenic target microorganisms such as bacteria, fungi and parasites (for example, protozoa) and / or related biomolecules, all of which require a high degree of selectivity (ie specificity) and sensitivity against purely chemical agents. 15 Additionally, articles do not predict when a health-related event is about to occur and signal to the user or care provider that prophylactic or remedial action is required before the onset of clinically observable symptoms.

BRIEF DESCRIPTION OF THE INVENTION The present invention is directed to disposable articles and other articles comprising a sensing device such as a biodetector diagnostic panel that can, in a set of 25 modalities, include at least one biodetector and at least one biorecognition element. The biodetector is adapted to detecting a biological analyte detected in body substances released from the body of a mammal (including body fluids, body wastes or other bodily discharges) and / or through the skin. The disposable articles may comprise a diagnostic panel adapted to determine the physical conditions or welfare state of a mammal, or the cause of a particular disease state, such as diarrhea, vaginal infections, sexually transmitted diseases ("STD's") and other diseases, and point out the care provider to the user or an occurrence driver. Examples of physical conditions or the state of well-being include, but are not limited to, ovulation and the onset of menstruation.

BRIEF DESCRICPION OF THE DRAWINGS Figure 1A is a plan view of a diaper embodiment of the present invention in a planar state with portions of the structure that are cut away to more clearly show the construction of the diaper. Figure 1B is a plan view of an example of a diagnostic panel having two biosensors therein. Figure 1C is a cross-sectional view of the diagnostic panel shown in Figure 1B, taken along the lines 1C-1C of Figure 1B. Figure 1D is a plan view of an example diagnostic panel similar to that shown in figures 1 and 1C, although «* '* - * • -.» Has a cleaning mechanism provided in it. Figure 1E is a cross-sectional view of the diagnostic panel shown in Figure 1D, taken along the lines 1 E-1 E of Figure 1 D. Figure 2 shows a perspective view of an isolation device of body waste for the present invention in a compressed state before activation. Figure 2A shows a sectional view taken along line 2A-2A of Figure 2. Figure 3A shows an ideal output function of a discontinuous response system of the present invention having an individual threshold level. Figure 3B shows an ideal output function of a discontinuous response system of the present invention having multiple threshold levels. Figure 4 shows an exemplary output function of a discontinuous response system of the present invention together with the first, second and third derivatives of the output function. Figure 4 shows a transfer function of a control system having a series of first order offsets having an equal time constant. Figures 5A and 5B show one embodiment of a response system of the present invention that includes an electrically sensitive gel. Figures 6A, 6B and 6C show another embodiment of a response system of the present invention that includes a gel __y_U_a__ ^ jk * - 'electrically sensitive. Figure 7 is a perspective view of a waste bag embodiment of the present invention. Figure 8 is a perspective view of an absorbent article that includes a waste bag. Figure 9 is a plan view of a pantiprotective embodiment of the present invention. Figure 9A is a cross-sectional view of the panty-protector mode shown in Figure 9, taken along line 9A-9A of Figure 9 showing the diagnostic panel therein in greater detail. Figure 10 shows a modality of colorimetric indicator that can be used to detect the amount of microorganisms, biomolecules or other substances of interest. Figure 11 shows a color comparison diagram that can be used to indicate the amount of substance present. Figure 12 is a plan view of a sanitary napkin embodiment of the present invention. Figure 13 is a plan view of a nterlabial device embodiment of the present invention. Fig. 14 is a cross-sectional view of the interlabial device shown in Fig. 13, taken along line 14-14 of Fig. 13. Fig. 15 is a side view of the interlabial device shown in Fig. 13. Figure 16 is a side view of the interlabial device ijjj ^ y ^^ a__á_á_ál- shown in Figure 13 showing how the interlabial device is held for insertion into the space between the lips of the user. Figure 17 shows how the interlabial device is used with respect to the wearer's body. Figure 18 is a perspective view of a tampon embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION As used herein the term "absorbent article" refers to devices that absorb and contain body exudates, and more specifically, refer to devices that are placed against or in proximity to the wearer's body to absorb and contain the different exudates discharged from the body. The term "disposable" is used herein to describe absorbent articles that are not generally intended to be washed or otherwise restored or reused as an absorbent article (i.e., are intended to be disposed of after a single use and, for preferably, to be recycled formed in compost or otherwise disposed of in an environmentally compatible manner). (As used herein, the term "deleted" is used to represent an element or elements of the article that are formed (joined and placed) in a particular position or place, as a unitary structure with other elements of the article or as a separate element attached to another Item of the article. As used herein, the term "attached" encompasses configurations by which one element is directly secured to another element by holding the element directly to the other element and configurations in the one element is indirectly secured to another element by fixing the element to a member or intermediate members who in turn are fixed to the other element). A "unitary" absorbent article refers to absorbent articles that are formed of separate parts joined to form a coordinated entity so that they do not require separate handling portions such as a separate support and liner. As used herein, the term "body substances" is substances released from the body of a mammal. The term "body substances" includes bodily fluids and biological fluid such as vaginal discharges, menses, sweat and saliva, body wastes such as urine and faeces and any other body discharge such as tears and ejaculation. One embodiment of an absorbent article that can be provided as a biodetector diagnostic panel in accordance with the present invention is a unitary disposable absorbent article, such as diaper 20 shown in Figure 1. As used herein the term "diaper" is refers to an absorbent article usually used by infants and incontinent people around the lower torso. The present invention is also applicable to other absorbent or non-absorbent articles such as incontinence briefs, incontinence undergarments, absorbent inserts, diaper supports and linings, ¿^ ^^ & ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ colostomy bags for a natural or artificial rectum, feminine hygiene devices (which include, but are not limited to, pantyhose, interlabial sanitary napkins and tampons), handkerchiefs, disposable towels, tissue paper (including tissue for bathroom), articles with saliva sample that can be taken, water absorbent articles, oil absorbing articles, spill clean bags, blotters bags, disposable swabs, bandages, therapeutic covers, supports, disposable heating pads and the like. Figure 1 is a plan view of the diaper 20 in a planar state with portions of the structure that are cut away to more clearly show the construction of the diaper 20. The portion of the diaper 20 facing the wearer is oriented towards the viewer, as shown in Figure 1, diaper 20 comprises 15 preferably a liquid-permeable top sheet 24; a backsheet impermeable to liquid 26; an absorbent core 28, which is preferably positioned at least a portion of the upper cover 24 and the rear cover 26; side panels 30; Elasticized leg folds 32, a waist features Elastic 20 34; and a generally designated fastening system 40. The diaper 20 is shown in Figure 1 to have a first waist region 36, a second waist region 38 opposite the first waist region 36, and a crotch region 37 located between the waist region 36. first waist region and the second waist region. The periphery 25 of the diaper 20 is defined by the outer edges of the diaper 20 in which the longitudinal edges 50 are generally displaced parallel on the center line 100 of the diaper 20 and the end edges 50 move between the longitudinal edges 50 generally parallel to the lateral center line 102 of the diaper 20. The base 22 of the diaper 20 comprises the main body of the diaper. The base 22 comprises at least a portion of the absorbent core 28 and preferably an outer cover layer that includes the top cover 24 and the back cover 26. If the absorbent article comprises a separate support and liner, the base 22 generally comprises the Support and lining. (For example, The support may comprise one or more layers of material to form the outer cover of the article and the liner may comprise an absorbent assembly that includes a top cover, a back cover and an absorbent core. In such cases, the support and / or liner may include a fastener that is used 15 to hold the liner in place through the time of use). For unitary absorbent articles, the base 22 comprises the main structure of the diaper with the added features to form the composite diaper structure. While the top cover 24, the back cover 26 and the absorbent core 26 can Assembled in a variety of well-known configurations, the preferred diaper configurations are generally described in U.S. Patent No. 3,860,003 entitled "Contractible Side Portions for Disposable Diaper" which was issued to Kenneth B. Buell on January 14, 1975; The patent 25 of the United States of America No. 5,151,092 issued to Buel on September 9, 1992; and the United States patent ^^ gjjj tj ^^ H ^^^^^^^^^^^ ^ ^ J ^ y ^^^^^^ and & ^^^^^ * ^^^^ of North America No. 5,221,274 issued to Buell the June 22, 1993; and U.S. Patent No. 5,554,145 entitled "Absorbent Article With Multiple Zone Structural Elastic-Like Film Web Extensible Waist Feature" which was issued to Roe et al. on September 10, 1996; U.S. Patent No. 5,569,234 entitled "Disposable Pull-On Pant" which was issued to Buell et al. on October 29, 1996; U.S. Patent No. 5,580,411 entitled "Zero Scrap Method for Manufacturing Side 10 Panels For Absorbent Articles "which was issued to Nease and others on December 3, 1996, and United States Patent Application No. 08 / 915,471 entitled" Absorbent Article With Multi-Directional Extensible Side Panels " presented on August 20, 1997 in the name of Robles et al., each of the Which is incorporated herein by reference. The back cover 26 is generally that portion of the diaper 20 positioned adjacent the confronting surface of the garment 45, of the absorbent core 48 which prevents the exudates absorbed and contained therein from soiling the articles. 20 that can make contact with the diaper 20, such as bedding and undergarments. The back cover 26 can be attached to the top cover 24, the absorbent core or any other element of the diaper 20 through attachment means known in the art. Suitable back film covers include 25 those manufactured by Tredegar Industries Inc. of Terre Haute, IN and sold under the trade names X15306, X10962 and X10964.

Other suitable backsheet materials may include breathable materials such as woven wefts, non-woven wefts, composite materials such as nonwoven webs, and microporous films such as those made by Mitsui Toatsu Co. of Japan under the designation ESPOIR NO.; EXXON Chemical Co., of Bay City, TX under the designation EXXAIRE; or monolithic films such as those manufactured by Clopay Corporation, Cincinnati. OH under the name HYTREL combination P18-3097. Such breathable composites are described in greater detail in PCT Application No. WO95 / 16746, published June 22, 1995 in the name of E.l. DuPont; the co-pending United States of America Patent No. 5,865,823 issued to Corru on February 2, 1999; U.S. Patent No. 5,571,096 issued to Dobrin et al. on November 5, 1996. Each of these references is incorporated herein by reference thereto. The back cover 26, or any portion thereof, may be elastically extensible in one or more directions. In one embodiment, the back cover 26 may comprise a film frame similar to structural elastic ("SELF"). A film frame similar to structural elastic is an extensible material that exhibits elastic-like behavior in the direction of elongation without the use of aggregate elastic materials. SELF frames suitable for the present invention are described in U.S. Patent No. 5,518,801 entitled "Web Materials Exhibiting Elastic-Like Behavior", which was issued for Chappel et al. On May 21, 1996, which is incorporated to the present by reference. In alternative embodiments, the back cover 26 may comprise elastomeric films, foams, filaments or combinations of these or other suitable materials with non-woven or synthetic films. The upper cover 24 is preferably compatible, soft touch and non-irritating to the wearer's skin. A suitable top cover 24 can be manufactured from a wide range of materials, such as porous foams; cross-linked foams; 10 movies movies with openings; or woven or nonwoven webs of natural fibers (e.g., wool or cotton fibers), synthetic fibers (e.g., polyester or polypropylene fibers), or a combination of natural and synthetic fibers. If the top covers include fibers, the fibers can be spin-spun, 15 carded, wet laid, blown by melt, hydroentangling, or otherwise processed as is known in the art. A suitable top cover comprising a web of fiber length polypropylene fibers that are manufactured by Veratec, Inc., a division of International Paper 20 Company, of Walpole, Massachusetts under the designation P-8. Suitable top-formed film covers are described in U.S. Patent No. 3,929,135, entitled "Absorptive Structures Having Tapered Capillaries", which was issued to Thompson on December 30, 25 1975; U.S. Patent No. 4,324,246 entitled "Disposable Absorbent Article Having A Satin Resistant _ ^ _ | _É_i_ß__a _-_ 4 _-___ i ___ ¿_i_ _ ^ _ ^ _ jt_J___t____ mi -'i. nin Topsheet ", which was issued to Mullane et al., on April 13, 1982, United States Patent No. 4,342,314 entitled" Resilient Plástic Web Exhibiting Fiber-Like Properties ", which was issued to Rabel and others on August 3, 1982, United States Patent No. 4,463,045 entitled "Macroscopically Expand Three-Dimensional Plástic Web Exhibiting Non-Glossy Visible Surfaces and Cloth-Like Tactile Impression", which was issued for Ahr, and others the July 31, 1984, and United States Patent No. 5,006,394"Multilayer Polymeric Film" issued to Baird on April 9, 1991. Other suitable top covers 24 are made in accordance with the patents of the United States of America Nos. 4,609,518 and 4,629,643 which were issued to Curro et al. On September 2, 1986 and December 16, 1986, respectively and in the United States of America Patent No. 4,695,422 and U.S. Patent No. 5,520,875, all of which are incorporated herein by reference. The films formed are available from The Procter & Gamble Company of Cincinnati, Ohio as "DRI-WEAVE" and from Tredegar Corporation of Terre Haute, Indiana as "CLIFF-T". The top cover 24 can be made of a hydrophobic material that can be treated to be hydrophobic so as to isolate the user's skin from the liquids contained in the absorbent core 28. If the top cover 24 is made of a hydrophobic material, preferably at minus the top surface of the cover Upper 24 is treated to be hydrophilic so that liquids will transfer through the top cover more quickly. The top cover 24 can be made hydrophilic by treating it with a surfactant people or by incorporating a surfactant into the top cover. Suitable methods for treating the topcoat 24 with a surfactant include spraying the topcoat material 24 with the surfactant and immersing the material within the surfactant. A more detailed description of such treatment and hydrophilicity is contained in U.S. Patent No. 4,988,344 entitled "Absorbent Article with Multiple Layer Absorbent Layers" issued to Riesing et al. On January 29, 1991 and patent of the United States. United States No. 4,988,345 entitled "Absorbent Articles with Rapad Acquiring Absorbent Cores" issued for Reising on January 29, 1991. A more detailed description of some suitable methods for incorporating surfactant into the top cover can be found in US: Statutory Invention Registration No. H1670, published on July 1, 1997 in the name of Aziz et al. Each of these references is incorporated herein by reference thereto. Any portion of the top cover 24 or other components of the article may be coated with a lotion as is known in the art. Examples of suitable lotions include those described in the patents of the United States of North America Nos. 5, 607,760 entitled "Disposable Absorbent Article Having a Lotioned Topsheet Containing an Emollient and a Poiyol > > - "" .Ü Polyester Immobilizing Agent "which was issued to Roe on March 4, 1997, United States Patent 5,609,587 entitled" Diaper Having A Lotion Topsheet Comprising A Liquid Poiyol Polyester Emollient And An Immobilizing Agent "which was issued to Roe on March 11, 1997, United States Patent No. 5,635,191 entitled "Diaper Having A Lotioned Topsheet Containing A Polysiloxane Emollient" which was issued to Roe et al. on June 3, 1997; U.S. Patent No. 5,643,588 entitled "Diaper Having A Lotioned Topsheet" which was issued to Roe et al. on July 1, 1997. The lotion may work alone or in combination with another agent such as hydrophobicization treatment before The top cover can also include or be treated with antibacterial agents, some examples of which are described in PCT Publication No. WO 95/24173 entitled "Absorbent Ar ticles Containing Antibacterial Agents in the Topsheet for Odor Control "which was published on September 14, 1995 in the name of Theresa Johnson. In addition, the top cover 24, the back cover 26 and any portion of the top or back cover can be engraved or given a matte finish to provide a more clothing-like appearance. The absorbent core 28 may comprise any absorbent material that is generally compressible, conformable, non-irritating to the wearer's skin and capable of absorbing and retaining liquids such as urine, and other body exudates. The absorbent core 28 can be manufactured in a wide variety of sizes and shapes (eg, rectangular, hourglass-shaped, T-shaped, asymmetrical, etc.) and may comprise a wide variety of liquid absorbent materials commonly used in disposable diapers and other absorbent articles such as crushed wood pulp, which is generally referred to as air felt, examples of other suitable absorbent materials include folded cellulose wadding; meltblown polymers including coform; cellulose fibers stiffened, modified or chemically interlaced; tissue paper, including tissue paper covers and tissue paper laminates; absorbent foams; absorbent sponges; superabsorbent polymer; absorbent gelling materials; or any other known absorbent material or combinations of materials. The configuration and construction of the absorbent core 28 can be varied (e.g., the absorbent core (s) or other absorbent structure (s) may have zones of different calibers, a hydrophilic gradient, superabsorbent gradient, or lower average density, and lower average acquisition zones. based on weight, or may comprise one or more layers or structures). Exemplary absorbent structures for use as the absorbent assemblies are described in U.S. Patent No. 4,610,678 entitled "High Density Absorbent Structures" issued to Weisman et al. On September 9, 1986; U.S. Patent No. 4,673,402 entitled "Absorbent Articles With Dual-Layered Cores" ^ uu_uuudteuajtkÉ > _? 7 issued to Weisman and others on June 16, 1987; U.S. Patent No. 4,834,735, entitled "High Density Absorbing Members Having Lower Density and Lower Basis Weight Acquisition Zones," issued to Alemany et al. on May 30, 1989; U.S. Patent No. 4,888,231 entitled "Absorbent Core Having A Dusting Layer" issued to Angstadt on December 19, 1989; U.S. Patent No. 5,137,537 entitled "Absorbent Structure Containing Individualized, Polycarboxylic Acid Crosslinked Wood 10 Pulp Cellulose Fibers "which was issued to Herron et al. On August 11, 1992, United States Patent No. 5,147,345 entitled" High Efficiency Absorbent Articles for Incontinence Management "issued to Young et al. On September 15, 1992. 1992; patent of the United States of America 15 5,342,338 entitled "Disposable Absorbent Article For Low-Viscosity Fecal Materials" issued to Roe on August 30, 1994; U.S. Patent No. 5,620,345 entitled "Absorbent Foam Materials For Aqueous Body Fluids and Absorbent Articles Containing Duch Materials" issued to DesMarais et al. 20 on November 9, 1993; U.S. Patent No. 5,387,207 entitled "Thin-Until-Wet Absorbent Foam Materials, For Aqueous Body Fluids and Process For Making Same" issued to Dryer et al. on February 7, 1995; and U.S. Patent No. 5,625,222 entitled "Absorbent 25 Foam Materials For Aqueous Fluids Made From High Internal Phase Emulsions Having Very High Water-To-Oil Ratios "issued to ,? á-S M-Tram í 1 y * _...__-- i - - * '- "- ~ .. * ... ~» _ .. * _, * _.. »*« * _ £ S. - -j-, i 'irfi DesMarais et al. On July 22, 1997. Each of these patents incorporated herein by reference.The diaper may also comprise at least one characteristic elastic waist 34 which aids provide improved fit and containment The elastic waist feature 34 preferably extends at least longitudinally outwardly from at least one waist edge 62 of the absorbent core 28 and generally forms at least a portion of the end edge 52 of the diaper 20. Disposable diapers are frequently constructed to have two elastic waist features, one placed in the first waist region 36 and one positioned in the second waist region 28. Moreover, while the elastic waist feature 34 or any of its elements constituents may comprise one or more separate elements fixed to the at 20, the elastic waist feature 34 may be constructed as an extension of other diaper elements 20, such as the back cover 26, the top cover 24 or both, the back cover 26 and the top cover 24. The waist feature elastic 34 may be constructed in a number of different configurations including those described in U.S. Patent No. 4,515,595 issued to Kievit et al. on May 7, 1985; U.S. Patent No. 4,710,189 issued to Lash on December 1, 1987; U.S. Patent No. 5,151,092 issued to Buell on September 9, 1992; and patent of the United States of America No. n i «» «« a.faaaj- - ». X * J ° - "'" - "**" • ta- 5,221,274 issued to Buell on June 22, 1993. Other suitable waist configurations may include waist covering features such as those described in the U.S. Pat. No. 5,026,364 issued to Robertson on June 25, 1991 and United States of America No. 4,816,025 issued to Foreman on March 28, 1989. All references mentioned above are incorporated herein by reference. The diaper 20 may also receive a fastening system 40. The fastening system 40 preferably comprises tape tabs and / or hook and loop fastening components, although any other known fastening means are generally acceptable. Illustrative fastening systems are described in U.S. Patent No. 3,848,594 entitled "Tape Fastening System for Disposable Diaper" issued to Buell on November 19, 1974; United States of America patent B1 4,662,875 entitled "Absorbent Article" issued to Hirotsu et al. on May 5, 1987; U.S. Patent No. 4,846,815 entitled "Disposable Diaper Having An Improved Fastening Device" issued for Scripps on July 11, 1989; U.S. Patent No. 4,894,060 entitled "Disposable Diaper With Improved Hook Fastener Portion" issued to Nestergard on January 16, 1990; patent of the United States of North America NO. 4,946,527 entitled "Pressure-Sensitive Adhesive Fastener And Method of Making Same" issued to Battrell on August 7, 1990; and the patent of the States United States of America previously referred to in the present No. 5,151,092 issued to Buell on September 9, 1992; and U.S. Patent No. 5,221,274 issued to Buell on June 22, 1993. The fastening system may also provide means for retaining the article in a disposable configuration as described in the United States patent. No. 4,963,140 issued to Robertson et al. On October 16, 1990. Each of these patents is incorporated herein by reference. In alternative embodiments, opposite sides of the garment may be sewn or welded to form a pair of pants. This allows the article to be used as a slip-type diaper such as the training pants. The diaper 20 may also comprise sliding side panels. The side panels 30 may be elastic or extensible to provide a more comfortable and conformational fit by adjusting the initial conformation of the diaper 20 to the wearer and holding this fit through the time of use even when the diaper 20 has been loaded with exudates already that the elasticized side panels allow the sides of the diaper 20 to expand and contract. While the diaper 20 preferably has the side panels 20 placed in the second waist region 28, the diaper 20 may be provided with side panels 30 positioned in the first waist region 36 or in the first waist region 36 and the second. waist region 38. The side panels may be constructed in any suitable configurations. The l.? .. l?.? Ír. ..M .III - • * - * "" • * * - 'examples of diapers with elasticized side panels are described in United States Patent No. 4,857,067 entitled "Disposable Diaper Having Shirred Eras" issued to Woods and others on August 15, 1989; U.S. Patent No. 4,381,781 issued to Sciaraffa et al. on May 3, 1983; United States of America Patent No. 4,983,753 issued to Van Gompel et al. on July 3, 1990; the patent of the United States of America previously referred to in the present No. 5,221,274 issued to Buell on September 9, 1992; U.S. Patent No. 5,669,897 issued to LaVon et al. on September 23, 1997 entitled "Absorbent Articles Providing Sustained Dynamic Fit"; US Patent Application Serial No. 08 / 915,471 entitled "Absorbent Article With Multi-Directional 5 Extensible Side Panels" filed on August 20, 1997 in the name of Robles et al., each of which is incorporated herein by reference. The diaper 20 preferably includes leg cuffs 32 that provide improved containment of liquids and other body exudates. The leg bends can also be referred to as leg bands, side flaps, barrier folds or elastic folds. U.S. Patent No. 3,860,003 discloses a disposable diaper that provides a collapsible leg opening having a side flap and one or more elastic members to provide an elasticated leg fold (a fold of jaÉt * ^ át- '~ - - jM? k _? _- ~ "- ** muí lili -11 < *" - * L-A-packing machine). US Pat. Nos. 4,808,178 and 4,909,803 issued to Aziz et al. On February 28, 1989 and March 20, 1990, respectively, describe disposable diapers having "upright" elastified fins (barrier folds). which improve the containment of the leg region. U.S. Patent Nos. 4,695,278 and 4,795,454 issued to Lawson on September 22, 1987 and to Dragoo on January 3, 1989, respectively, describe disposable diapers having folds 10 in duplicate, including packaging folds and barrier folds. In some embodiments, it may be desirable to treat all or a portion of the leg folds with a lotion as described above. The diaper 20 can include bags to receive and contain 15 debris, separators that provide empty spaces for debris, barriers to limit the movement of debris in the article, compartments or gaps that accept and contain waste materials deposited in the diaper and the like or combinations thereof. The examples of bags and separators 20 for use in absorbent products are described in U.S. Patent No. 5,514,121 issued to Roe et al. On May 7, 1996, entitled "Diaper Having Expulsive Spacer"; U.S. Patent No. 5,171,236 issued to Dreier et al. on December 15, 1992, 25 entitled "Disposable Absorbent Article Having Core Spacers"; U.S. Patent No. 5,397,318 issued for Dreier on March 14, 1995, entitled "Absorbent Article Having A Pocket Cuff "; the United States patent of North America No. 5,540,671 issued to Dreier on July 30, 1996, entitled "Absorbent Article Having A Pocket Cuff With An Apex "; and PCT application WO 93/25172 published December 3, 1993, entitled" Spacers For Use In Hygienic Absorbent Articles And Disposable Absorbent Articles Having Duch Spacer "and U.S. Patent No. 5,306,266, entitled "Flexible Spacers For Use In Disposable Absorbent Articles", issued to Freeland on April 26, 1994. The examples of compartments or holes are described in the patent of the States United States No. 4,968,312, entitled "Disposable Fecal Compartmenting Diaper ", issued for Khan on November 6, 1990; the patent of the United States of America No. 4,990,147, entitled "Absorbent Article With Elastic Liner for Waste ß Material Isolation", issued for Freeland on February 5, 1991; U.S. Patent 5,662,840 entitled "Disposable Diapers", issued to Holt and others on November 5, 1991; and U.S. Patent 5,629,755 entitled "Trisection Topsheets For Disposable Absorbent Articles And Disposable Absorbent Articles Having Such Trisection Topsheets ", issued to Freeland et al. On December 14, 1993. Examples of suitable transverse barriers are described in U.S. Patent 5,554,142 entitled "Absorbent Articles Having Multiple Effective High Transverse Partition "issued on September 10, 1996 in the name of Dreier and *? **? ifi &l? . «..-. -1.1- others; PCT patent WO 94/14935 entitled "Absorbent Article Having An Upstanding Transverse Partition" published July 7, 1994 in the name of Freeland et al .; and U.S. Patent 5,653,703 Absorbent Article Having Angular Upstanding Transverse Partition, issued August 5, 1997, to Roe et al. All references cited above are incorporated herein by reference thereto. The embodiments of the present invention may include a handling device 110 as shown in Figure 7. The handling device 110 includes a waste bag 111 for collecting feces, urine, or both. The waste bag 111 may have an opening 121 and a flange 112 surrounding the adhesive attachment opening preferable to the perianeal area of a user. In addition, the waste handling device 110 has been found to be particularly useful and beneficial when used in conjunction with a garment or diaper, preferably a disposable diaper. An example of an absorbent article, such as the diaper 120 that includes a waste bag 111 is shown in Figure 8. If associated with a diaper 120 or other garment, the waste bag 111 can be placed on or attached to any surface of the garment. Article. In one embodiment, the waste bag 111 is attached to the upper cover 124 of the diaper 120. The waste bag 111 is preferably a flexible receptacle for the containment of excreted urine or urine. Therefore, the waste bag 111 is preferably impermeable to liquid and can still be breathable. In addition, the waste bag ________________________ - • - - - - - • - 111 is designed with sufficient strength to withstand typical wear conditions, such as sitting in. Waste bag 111 may comprise one or multiple layers, in one embodiment, the waste bag. it may comprise 3 layers, such as preferably a film and two non-woven layers.The layers of bag material may comprise any bag material preferably so that the bag is impermeable to liquid.In a preferred embodiment of the present invention, a bag may be formed. laminate from a non-woven layer and a film Suitable film materials for any of the film layers preferably comprise a thermoplastic material The thermoplastic material may be vapor permeable or impermeable and may be selected from all types of adhesives hot melts, polyolefins especially polyethylene, polypropylene, polyolefins amo Rifles and the like: melt-forming components containing material comprising polymeric fibers or binders including natural fibers such as cellulose, wood pulp, cotton, jute, henequen; synthetic fibers such as glass fiber, rayon, polyester, polyolefin, acrylic, polyamide, aramid, polytetrafluoroethylene metal, polyimide; binders such as high melt / low melt polymer, bicomponent, polyester copolymer, polyvinyl chloride, polyvinyl acetate-chloride copolymer, polyamide copolymer, material comprising blends wherein any of the constituent materials are non-meltable; materials Air and vapor permeable materials including microporous films such as those described above with respect to the back cover and monolithic breathable materials such as HYTRELL ™ available from DuPont and Pebat ™ available from ELF Atochem, France . The waste bag 111 can have any shape or size. Preferred shapes include flat circular-type bags, cone-shaped bags, truncated cone-shaped bags and truncated pyramidal or pyramidal bags and flat T-shaped bags. In addition, the waste bag 111 can be provided with a unitary piece of material or with a number of pieces of material which can be identical or different and which can be sealed at their respective peripheries. The waste bag 111 may contain absorbent material. The absorbent material may comprise material that is capable of absorbing and retaining liquids. The absorbent material may comprise a wide variety of liquid absorbent materials commonly used in disposable diapers and other absorbent articles. Some examples are described herein with respect to the absorbent core. The waste bag 111 is provided with an opening 121 whereby faecal material or urine is received from the body of before being stored within the bag cavity. The opening 121 is preferably surrounded by a flange 112 and can be provided in any shape or size such as circular, oblong, heart-shaped and can be symmetrical or asymmetric, preferably the opening has a oblong configuration either in the longitudinal or transverse direction. The tab may comprise directions designed to adjust the perianeal, genital and / or coccygeal area of the user. The tab 112 should be made of a soft, flexible material that can be formed into mesh to allow easy placement of the tab 112 to the perianeal or urogenital region. Typical materials include non-woven materials, fabrics, open cell thermoplastic foams, closed cell thermoplastic foams, open cell foam composites and extensible nonwovens and films. The waste bag 111 further preferably comprises joining means for securing the device to the user. Said means may comprise strips and / or a pressure-sensitive adhesive compatible with the body applied to the portion facing the user of the waste bag 111 or the flange. Any user-friendly water-resistant pressure sensitive adhesive can be used to attach the device to the perianeal or urogenital area of the user, such as adhesive hydrocolloids and hydrogel adhesives. Particularly effective adhesives to provide the desired adhesive properties to secure the flange to the wearer's skin in the sensitive perianeal area, while allowing relatively painless application and removal, are formed from entanglement polymers with a plasticizer to form a three-dimensional matrix. The present invention may also be presented in and / or other absorbent or non-absorbent articles such as incontinence briefs, incontinence undergarments, inserts t-t. »? - _ «. a.a.- ... ..- J. Jfl- -. «. < . »-. . " Absorbent, diaper holders and liners, colostomy bags for a natural or artificial rectum, feminine hygiene devices (which include, but are not limited to, pantiliners, sanitary napkins, intralabial devices and tampons) ), handkerchiefs, disposable towels, tissue paper (facial and toilet paper), articles with a sample of saliva that can be taken, such as toothbrushes, lipsticks or lip balms, water absorption articles, oil absorption articles , spill clean bags, blotters bags, disposable swabs, bandages, therapeutic covers, supports, disposable heating pads, and the like. The diagnostic panel may also be located separately from one or more of the types of articles described above, and one or more of the items described above may be used as a collection device to collect the body fluid or fluids of interest, and the body fluid thus collected can thus be contacted with the diagnostic panel. In addition, in some alternative embodiments, scouring pads, patches, liquid containers and the like can be used to collect the bodily fluid or fluids of interest. Non-limiting examples of panty-hose and sanitary napkins that can be provided with a diagnostic device include those manufactured by The Procter & Gamble Company of Cincinnati, Ohio as: ALWAYS® ALLDAYS® with DriWeave® Pantiprotectors manufactured in accordance with United States Patents 4,342,314, 4,463,045, 4,556,146, B1 4,589,876, 4,687,478, 4,950,264, 5,009,563, .. i * ". * -.« »^ .. * .U. ___ 5,267,992, and Re. 32,649: ALWAYS® Regular Maxi; ALWAYS® Ultra Maxi with Wings; ALWAYS® Maxi with Wings; ALWAYS® Ultra Long Maxi with Wings; ALWAYS® Long Super Maxi with Wings; and ALWAYS® Overnight Maxi with Wings. An example of a pantiprotector with a diagnostic device is shown in Figures 9 and 9A. An example of a sanitary napkin with a diagnostic device is shown in Figure 12. Non-limiting examples of the interlabial devices that can be provided with a diagnostic device are described in U.S. Patents 5,762,644; 5,885,265; 5,891,126; 5,895,381; 5,916,205; 5,951,537; 5,964,689; 5,968,026; Des. 404,814; and Des. 413,669. An example of an interlabial device with a diagnostic device is shown in Figures 13-17. Non-limiting examples of buffers that can be provided with a diagnostic device and applicators thereof are described in United States Patents 4,726,805; 4,846,802; 4,960,417; 5,087,239; 5,279,541; 5,346,468; 5,348,534; 5,531,674 and 5,566,435. In addition, the diagnostic device can also be fitted with a digitally insertable buffer. An example of a buffer with a diagnostic device is shown in Figure 18. Article 20 preferably includes at least one indicating or detecting device such as a biosensor 60. As used herein the term "biodetector" includes a component that comprise one or more elements that are * ^ - > - * • * - > • »» > ____ = _ * ___, adapted to detect one or more target microorganisms or related biomolecule (e.g., an enzyme detector, organelle detector, tissue detector, microorganism detector, electrochemical or immunodetector detector). The microorganisms may or may not be pathogenic. The biosensor elements preferably have the ability to provide a signal of said detection to the user, the care provider or an actuator. In some embodiments, the elements may be biologically reactive, chemically reactive, binding or may operate through physical treatment. The term "biologically reactive" is defined to have the ability to selectively interact with and preferably bind, target microorganisms and / or related biomolecules as described herein. The term "biologically reactive" includes, but is not limited to, elements that detect the presence of enzymes. Generally, biosensors function to provide a specific binding means and thereby detect a biologically active target analyte. In this way, the biosensor is highly selective, even when presented with a mixture of many chemical and biological entities, such as feces, menstrual discharges, sweat and saliva. Chemical detectors, on the other hand, which rely on chemically reactive media, generally do not have the high selectivity or amplification properties of biosensors and are therefore not as suitable for detecting biologically active analytes, especially when they are present in low concentrations and / or in a complex medium such as fluids -j - * - J? - * * * • * - * - • _ _j corporal, body wastes and other bodily discharges. Frequently the biological analyte is a minor component of a complex mixture comprising a multiplicity of biological and other components. Therefore, in biodetector applications, the detection of target analytes to thousands of millions, parts per trillion million or even lower levels is necessary. Consequently, discrimination ratios of approximately 107-108 or greater may be required for the biosensor to recognize the target biological analyte in a complex mixture. The biosensor used in the present invention preferably comprises a recognition element or molecular recognition element that provides the highly specific binding or detection selectivity for a particular analyte. The biorecognition element, or system, can be biologically derived material such as an enzyme or enzyme sequence; an antibody, a membrane receptor protein; DNA; an organelle, a natural or synthetic cell membrane; a bacterial, vegetable or animal cell intact or partially viable or non-viable; or a piece of plant or mammalian tissue, and generally functions to interact specifically with a target biological analyte. The biorecognition element is responsible for the selective recognition of the analyte and the physicochemical signal that provides the basis for the output signal. Biodetectors may include biocatalytic biodetectors and bioaffinity biosensors. In the biocatalytic biodetector modalities, the biorecognition element is "biocatalytic" and & Í, ... »...« -. » «.-.. - __. < . ...-_-, _ t., k .- ^ A a____? it may comprise an enzyme, organelle, piece of plant or mammalian tissue, or whole cells, the selective binding sites "inverted" (ie, they may be used again during the detection process) resulting in significant amplification of the signal of entry. Biocatalytic detectors such as these are generally useful for continuous detection in real time. Bioaffinity detectors are generally applicable to bacteria, viruses and toxins and include biodetectors based on chemoreceptor and / or immunological detectors (ie immunodetectors). Chemoreceptors are complex biomolecular macro-assemblies responsible in part for a viable organism's ability to detect chemical elements in their environment with high selectivity. Chemoreceptor-based biosensors comprise one or more natural or synthetic chemoreceptors associated with means to provide a signal (visual, electrical) of the presence or concentration of a target biological analyte. In certain embodiments, the chemoreceptor may be associated with an electrode (i.e., an electrical transducer) to provide a detectable electrical signal. The chemoreceptors may include complete or partial nerve groups (e.g., from antenna or other sensing organs) and / or full or partial synthetic or natural membranes. On the other hand, the elements of biorecognition of immunodetectors are generally antibodies. Antibodies are highly specific and can be made for bacteria, viruses, fragments of microorganisms (bacterial cell walls, «?, I,? .. ÍM - -._ .. 1 .., Ll .. parasite eggs, or portions thereof, etc.) and large biomolecules. Suitable antibodies can be monoclonal or polyclonal. In any case, bioaffinity biodetectors are generally irreversible since the receptor sites of the biosensor become saturated when exposed to the target biological analyte. In certain embodiments, biocatalytic bioaffinity biodetectors may be combined, such as RNA / DNA probes or other high affinity binding systems where the initial biorecognition event is followed by the biological amplification of the signal. For example, a specific bacterium can be detected by a biosensor comprising a genetic material, such as DNA, as a biorecognition and PCR amplification element (ie, polymerase chain reaction) to detect minor numbers of organisms, preferably less than or equal to about 500. Biocatalytic bioaffinity biodetector systems are described in greater detail in Journal of Chromatoqraphv. 510 (1990) 347-354 and in kira-Othmer Encvclopedia of Chemical Technology. 4a. Edition (1992), John Wiley &; Sons, NY, the descriptions of which are incorporated by reference herein. The biosensors used in the present invention can detect biologically active analytes related to impending or current human systemic disease states, including, but not limited to, pathogenic bacteria, parasites (e.g., any stage of the life cycle, including eggs or portions thereof). l-t-t Í ?? t, jfa.-4.-i.,. -riX., - - * »'" * __________________ the same, cysticercos or organism nmaduro) virus, fungus, such as Candida albicans, pathogenic antibodies and / or toxins produced in microbial form.In addition, the biodetector can activate in a biological target analytes related to impending or currently localized health issues such as stress proteins (eg, cytosines) and IL-1 »(interleukin 1-») that may precede the clinical presentation of skin irritation or inflammation In the preferred modalities, the biosensor functions as a proactive protective detector detecting and signaling the user or caregiver of the imminent condition before the presentation of the clinical symptoms.This allows time for the prophylactic or remedy treatments to be administered to the user. They can significantly reduce, if not avoid, the severity and duration of the symptoms.In addition, the biodetector 60 to the detecting the presence of a target biological analyte in the user's body waste (eg, feces) can detect residual contamination on a surface, such as the skin in contact with the biosensor and provide an appropriate signal. The physicochemical signal generated by the biorecognition element or elements can be visually communicated to the user or care provider (for example, through a color change visible to the human eye as a colorimetric detector). Other modes can produce optical signals, which may require other instrumentation to improve the signal. These include fluorescence, bioluminescence, reflectance resonance ^ ¡¡¡¡¡¡¡¡¡¡¡¡¡^ ^ ^^^^^^^^^^ ¿¡¡¡¡¿¿¿¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡ -Ü_fÉ -____-, total internal, surface plasmon resonance, IBIS I and IBIS II method and other methods based on laser beam. Illustrative surface plasmon resonance biosensors that may comprise bioconjugated surfaces as biorecognition elements are available as IBIS I and IBIS II from Xan Tecd Analyst Systems of Muenster, Germany. Alternatively, the signal can be processed through an associated transducer, which, for example, can produce an electrical signal (e.g., current, potential inductance or impedance) that can be displayed (e.g., in a reading device). such as an LED or LCD screen) or that activates an audible or tactile signal (for example vibration) or that can activate an actuator as described herein. The signal can be qualitative (that is, indicate the presence of the target biological analyte) or quantitative (that is, a measurement of the quantity or concentration of the target biological analyte). In such embodiments, the transducer may optionally produce an optical, thermal or acoustic signal. In any case, the signal may be durable (i.e., stable and readable over a length of time typically at least equal in magnitude to the useful life of the article), or transient (i.e., recording a measurement in real time) . Additionally, the signal may be transmitted to a remote indicator site (e.g., of a cable or transmitter, such as an infrared or radio frequency transmitter) including other locations within or on the remote item or device. In addition, the biosensor 60 or any of its components may be adapted to detect ___ »__« _______, _ • -_ »" * -1 * - and / or only indicate target biological analyte concentrations over a predefined threshold level (for example, in cases where the target biological analyte is normally present in the body substance, or when the concentration of the analyte is below a known "dangerous" level.) As described above, the target analytes that the biosensors of the present invention are adapted to detect may be pathogenic microorganisms such as pathogenic microorganisms involved in human gastrointestinal diseases, especially those that result in diarrhea. This type of pathogen is particularly important to monitor due to the number of children who become seriously ill or die every year from diarrheal diseases. It has been found that severe chronic diarrhea can result in weight loss and retardation of permanent physical and mental development. A non-limiting list of pathogenic bacteria that the biosensor 60 can detect any of the different pathogenic strains of Escherichia coli (commonly known as E. Coli), including enteropathogenic E.coli (EPEC) strains, enterotoxigenic E. coli (ETEC), E. Coli (EHEC), enterohemorrhagic E. coli (EIEC), enteroinvasive and E. Coli, (EAEC) enteroadherent; Salmonella strains, including S. typha, S. paratyphi, S. enteriditis, S. typhimurium, and S. heidelberg; strains of Shigella, such as Shigella sonnei, Shigella Felxneri, Shigella-boydii, and Shigella Dysenteriae; vibro cholerae; Mycobacterium tuberculosis; Yersinia enterocolitica; Aeromonas hydrophila; Plesiomonas shigelloides; strains of _! _______. ».« «_, _, _, _, _, _, _, _, _, _, _, _,,,,,,,,,,,,,,,,,,,. Bacteroid coli; Bacteroides fragilis; and Clostridia strains, which include C. septicum, C. perfringens, C. botulinum, and difficile. Non-limiting examples of commercially available biosensors 5 for detecting E. Coli are available from AndCare, Inc. of Dirham, NC, as test kit # 4001 and from Meridian Diagnostics, Inc. of Cincinnati, OH, as a test of // 77 / 77i // 7? Card®STAT! E. Coli plus. Another non-limiting example of the commercially available biodetector adapted to detect rotavirus is available from Meridian 10 Diagnostics, Inc. of Cincinnati, OH, as / mA77ivr? OCard®STAT! test. Another non-limiting example of a commercially available biodetector adapted to detect Another non-limiting example of a commercially available biodetector adapted to detect Cruptosporidium and giardia lamblia is available from Meridian 15 Diagnostics, Inc. of Cincinnati, OH, as the Merifluor Crypto / Giardia assay. Another non-limiting example of a commercially available biosensor adapted to detect C. difficile toxin is available from Meridian Diagnostics, Inc. of Cincinnati, OH, as the A C. difficile A toxin assay. ABTECH, 20 Scientific, Inc. of Yardley, PA offers "bioanalytical biotransducers" available as BB Au-1050.5-FD-X which can become biospecific (for microorganisms or other target analytes as described herein) by covalent immobilization of polypeptides, enzymes, DNA antibodies to their surfaces.

Other suitable microbial biodetectors or detector systems for one or more pathogens of interest are described in the patents of United States of America 5,948,694; 6,001,556; 5,106,965 (adenovirus); 5,869,275 (gram negative organisms); 5,795,717. { Shigella); 5,830,341; 5,795,453; 5,354,661; 5,783,399; 5,840,488; 5,827,651; 5,723,330 and 5,496,700, all of which are incorporated herein by reference. The target analytes that the biosensors of the present invention are adapted to detect can also be viruses. These may include viruses that induce diarrhea such as rotavirus, adenovirus (a DNA virus), astrovirus (an RNA virus), calcivirus (an RNA virus) and Norwalk virus (RNA virus), and other viruses such as rhinovirus and the human immunodeficiency virus (HIV). An illustrative biosensor adapted to detect HIV is described in the aforementioned US Patents 5,830,341 and 5,795,453. The description of each of these patents is incorporated herein by reference. In alternative embodiments, the target analytes that the biosensors of the present invention are adapted to detect may also be parasites, especially those that inhabit the gastrointestinal tract during some point in their life cycle, (e.g. eggs or portions thereof). , oocytes, trophozoites, adults). Said parasites may include protozoa, worms, and other gastrointestinal parasites. Other examples of parasites that can be detected include entamoeba histolytica (which causes amoebic dysentery), Cryptosoporidium, Giardia lamblia, and Dientomeba fragilis, Trypana cruzi (which causes Chagas disease), and Plamodium falciparum. _, __ t_. .-. «.. I ~ .lw *«. In other embodiments, the target analytes that the biosensors of the present invention are adapted to detect can be fungi such as Candida albicans. In addition to the pathogenic bacteria, certain beneficial colony bacteria can be detected and / or measured as a health indicator, such as the Bifidobacteria and Lactobacillus strains. The target analytes that the biosensors of the present invention are adapted to detect can also be proteins or antigens related to skin discomforts.

Preferably, those analytes are detectable on or on the surface of the skin, preferably prior to the presentation of clinically observable skin irritation. These may include tension proteins such as cytosines, histamine, and other immune response factors that include interleukins (such as 11_- 1 •, 15 IL-2, I L-3, I L-4 and IL-8) and interferons (including interferons a and g). Again, these are preferably detectable by the biosensor 60 before the onset of reddening, irritation or clinically observable dermatitis. Additionally, the biosensors of the present invention may be adapted for 20 detecting enzymes or other biological factors involved in skin irritation (eg, diaper rash), including trypsin, chymotrypsin and lipase. In certain preferred embodiments of the present invention, the article may comprise a diagnostic panel. A "panel of "Diagnosis" as used herein includes the combination of two or more biosensors or other types of indicators ___ and, - i. ..a * ___ ^ adapted to detect the presence or absence of at least two of a specific group of substances. These substances can be indicators of the conditions or physical state of well-being of a mammal, or the cause of a particular disease state, such as diarrhea, vaginal infections, sexually transmitted diseases (STDs) and other diseases. The biosensors may, for example, be adapted to detect the presence of at least two of a specific group of pathogens for the purpose of determining the class of pathogens or specific pathogens that 10 cause a particular disease state, usually in order to provide a diagnosis that leads to a specific course of remedial medical treatment. For example, the article may comprise a diagnostic panel adapted to determine the pathogenic cause or causes of diarrhea infections or 15 vaginal. Examples of physical conditions or the state of well-being that the diagnostic panel may be adapted to detect include, but are not limited to, ovulation and the onset of menstruation. Examples of substances that the diagnostic panel may be adapted to detect in order to determine 20 the onset of menstruation includes, but is not limited to: progesterone, pH, and red blood cells (hemoglobin). In a modality a diagnostic panel particularly suitable for the articles of the present invention, the diagnostic panel may provide an indication to the user of the 25 presence of one of the common viral causes of diarrhea. This article provides an indication that alerts the user, provider of care or health professional that the cause of diarrhea is of a viral nature. Said diagnostic panel may comprise biosensors adapted to detect at least two of the following group of viruses: rotavirus, adenovirus, astrovirus, calcivirus, 5 and Norwalk virus. However, it is preferred that the diagnostic panel be able to detect the presence of as many of the previous viral causes of diarrhea as possible. In any case it points out to the user, care provider or health professional from the diagnostic panel can indicate the specific viral cause of the 10 diarrhea or may only indicate that the cause is viral in nature. Alternatively, the article may comprise a diagnostic panel adapted to detect any of the potential bacterial causes of diarrhea or vaginal infections. In In certain preferred embodiments, the diagnostic panel may comprise biosensors adapted to detect at least two of the following group of bacteria: strains of EPEC, ETEC, EHEC, EAEC, EIEC, Campylobacter jejuni, Vibrio cholerae, Campylobacter jejuni, Vibrio cholerae, and Shigella, including S. sonnei and S. 20 flexneri .. However, it is preferred that the diagnostic panel be able to detect the presence of as many of the previous bacterial causes of diarrhea or vaginal infections as possible. Preferably, the presence of any of the above bacterial causes of diarrhea or vaginal infections are 25 indicated by the diagnostic panel. In any case, the signal to the user, care provider or health professional of the panel of Diagnosis preferably indicates the specific cause (ie, bacterial pathogen) of diarrhea or vaginal infections allowing early and specific treatment of the health condition. Alternatively, the article may comprise a diagnostic panel adapted to detect any of the viral and bacterial potential causes of diarrhea (or vaginal infections). In certain preferred embodiments, the diagnostic panel may comprise one or more biosensors adapted to detect at least one virus and one or more biosensors adapted to detect at least one bacterium. However, it is preferred that the diagnostic panel be able to detect the presence of as many of the previous bacterial and viral causes of diarrhea (or vaginal infections) as possible. In any case, the signal to the user, care provider or health professional from the diagnostic panel preferably indicates the specific cause (ie, viral or bacterial pathogen) of the diarrhea (or vaginal infections), allowing early treatment and specific to the condition of health. Alternatively, the article may comprise a diagnostic panel that may be adapted to detect specific protozoal causes of diarrhea. In this embodiment, the diagnostic panel may comprise biosensors adapted to detect one or more of the group: Cryptosoporidium, Giardia lamblia, Dientomeba fragilis and Entamoeba histolytica. Again, it is preferred that the diagnostic panel be able to detect the 11 I i mi l -aa ..... ..Xti-n. .-.- ,, .. - presence of as many of the previous protozoan causes of diarrhea as possible. In any case, the signal to the user, care provider or health professional preferably indicates the specific protozoa that cause diarrhea, allowing early and specific treatment of the health condition. Of course, the diagnostic panel may also be adapted to detect any combination of the pathogenic causes of diarrhea. For example, the diagnostic panel may comprise biosensors adapted to detect two or more of each of the causes of viral, bacterial or protozoal diarrhea mentioned hereinbefore. The article may comprise a diagnostic panel that is adapted to detect and indicate the specific protozoal or pathogenic causes of vaginal infections, similar to the manner described in the two preceding paragraphs for the case of diarrhea. A non-limiting embodiment of an illustrative diagnostic panel 10 suitable for incorporation into a disposable diaper is shown in Figures 1B, 1E, diagnostic panel 10 includes two biosensors 12, a biosensor 14 adapted to detect E. coli H0157 and a biosensor 16 adapted to detect rotavirus. The diagnostic panel 10 can be made by obtaining biosensors 12 from the equipment / A77 / 77ív / 7? Card®STAT! E. coli 0157 Plus and / m? 77t / 7? Card®STAT! Rotaviruses available from Meridian Diagnostics. The biosensors are removed from their respective "cards", and attached to an exposed surface of a substrate 18 to fc- * "•" »- ___ * through any means of bonding or bonding as known in the art, such as an adhesive The substrate 18 may comprise any suitable material such as paper, cardboard, a polyolefin film, etc. In one embodiment, the substrate 18 is a relatively rigid carbon material As shown in Figure 1C a mask 17 having openings corresponding to the biosensors 12 can be applied to the surface of the substrate 18 to ensure fecal contact only with the biosensors 12 and not the rest of the surface of the substrate 18. The substrate 18, or the The mask 17 can be made of any material such as plastic, cardboard or paper and can comprise marks, instructions or other indications to assist in the execution of the test or the interpretation of the results. For example, the substrate 18 may comprise a color change "key" to assist the user in 15 the correct interpretation of the results. In diagnostic panel 10 is attached to the surface confronting the user of the diaper upper cover in the crotch region of the diaper corresponding to the location of the user's rectum through any means of attachment or binding as is known in the art. technique 20 such as adhesive. Alternatively, the diagnostic panel can be made by joining the E. coli 0157 Plus and // 77 / 77L / noCard®STAT! Biosensing cards. Rotavirus mentioned above directly to the surface confronting the user of the upper cover of the diaper in the crotch region of the diaper that 25 corresponds to the location of the user's rectum. In any of the above modalities, the cover The diaper upper can comprise at least one aperture and the diagnostic panel 10 can be attached to the region of the underlying absorbent core corresponding to the apertures of the top cover. Regardless of the configuration chosen, the feces make contact with the "sample" region of both biosensors 12 defecation. The fecal sample can optionally be diluted with a diluent, such as the diluent provided with the // 77/77 case (vnoCard®STAT!) To the diaper removal from the user or the application of the fecal sample to the biodetectors 12. This is especially useful when the fecal sample is solid, in any case the results of the biosensors 12 can be read approximately 10 minutes after each defecation or, if diluent was added, 10 minutes of the dilution of the sample In certain alternative modalities, the biodetectors 12 can be attached to any diaper region, such as the top cover, the back cover, the folds and fasteners.In those embodiments, the fecal sample can be applied, after optional dilution to the test region of both biodetectors. by the user or the person providing the care to the diaper opening or the removal of the user's diaper In any of the above modalities, the combination of the two biodetectors 12 provides a diagnosis for diarrhea based on common viral (rotavirus) and bacterial diarrhea causes (E. coli). As shown in Figures 1D and 1E, the above diagnostic panel 10 may also comprise an integral cleaning mechanism 19 for removing excess stool from the i ^ j ^^^. * .., _. ~ _. .. biosensors 12 to facilitate the accurate interpretation of the results. The cleaning mechanism 19 may comprise a slide bar including a flexible cleaning fin having little or no free space with the upper surface of the biodetector 12 that can manually slide the diagnostic panel 10 confronting to scrape the excess stool from the surface of the biodetector 12. Alternatively, the colorimetric biodetector films described and claimed in US Pat. No. 6,001,556 adapted to detect rotavirus and E. coli, and optionally other diarrheal pathogens as described herein, may be used instead of the biodetectors Meridian Diagnostics // 77mfv / 7? Card®STAT! in the diaper modalities described above. Those films have the advantage of being thinner and smaller in area than many of the alternative biosensor systems. It should be optionally noted that any of the other biosensors described herein may be substituted or added to the previous examples, including the colorimetric and electrochemical biosensors. The biosensors of the present invention may also optionally comprise biorecognition systems, including enzymes and binding proteins such as antibodies immobilized on the surface of the physicochemical transducers. For example, a specific strain of bacteria can be detected through biosensors using antibodies raised against the bacterial strain. Alternatively, a target bacterium can be -t-á, --.-, - »- *." -. i. < --- * .. detected by a biorecognition element (including antibodies and synthetic or natural molecular receptors) specific for the extracellular products of the target bacterium, such as toxins produced by the strain (ie E. coli). Illustrative enzyme electrodes that can be used to detect phenols (e.g., in urine or feces), include tyrosinase-based electrodes or polyphenol oxidase enzyme electrodes described in U.S. Patent No. 5,676,820 entitled " Remote Electrochemical Sensor, "issued to Joseph Wang and others on October 14, 1997 and United States Patent No. 5,091,299 entitled" An Enzyme Electrode For Use In Organic Solvents, "issued to Anthony P. Turner and others, on February 25, 1992, respectively. Both patents are incorporated herein by reference. In any of the above examples, the specific microorganism can be detected directly or can be detected by binding of a toxin, enzyme, or other protein produced by the organism or an antibody, such as a monoclonal antibody, specific to the organism. Illustrative biodetectors adapted to detect the proteolytic enzymes described in U.S. Patent 5,607,567 and toxins in U.S. Patents 5,496,452; 5,521,101; and 5,567,301. In a non-limiting embodiment of an illustrative diagnostic panel for vaginal infections, the biodetector may be _.k-, adapted to detect several specific types of bacteria that may be the cause of bacterial vaginosis, including the species Gardnerella vaginalis, Prevotella bivia, Bacteroides, the species Mycoplasma hominis, Mycoplasma hominis, and Mobiluncus. The biosensor may be adapted to detect non-specific types of bacteria that may be the cause of bacterial vaginosis. The biosensor may also be adapted to detect fungi such as the Candida species, which is the cause of yeast vaginitis (or yeast infections). The biosensor may also be adapted to detect protozoa such as Trichomonas vaginalis, which is the cause of trichomoniasis, a non-referable sexually transmitted disease, Chlamydia or other sexually transmitted diseases. A non-limiting example of a commercially available biosensor adapted to detect G. vaginalis is the EXAM® vaginalis PIP activity test card available from Litmus Concepts, Inc. of Sana Clara, CA. The FEM EXAM® vaginalis test card described in United States Patent 5,571,684. A non-limiting example of a commercially available biosensor adapted to detect non-specific causes of bacterial vaginosis is the EXEM® pH and Amines FEM test card available from Litmus Concepts, Inc. The FEM EXAM® pH and Amines card is described in U.S. Patent 5,660,790. Other Litmus Concepts patents and patent publications of interest include: 5,268,146; 5,416,003; 5,585,273; 5,897,834; and PCT publication WO 94/24306. Non-limiting examples of biosensors adapted to detect Candida and Chlamydia are described in U.S. Patents 5,741,662 and 5,773,234, respectively, issued to Quidel Corporation of San Diego, CA.

In other preferred embodiments, the diagnostic panel may comprise biosensors adapted to detect at least two of the following group of bacteria: various types of bacteria that can be the cause of bacterial vaginosis, including species Gardnnerella vaginalis, Prevotella bivia, Bacteroides, and species Mycoplasma hominis, and Mobiluncus. Figure a9 shows a non-limiting panty-protector mode 920 containing an illustrative diagnostic panel 960 for detecting the different causes of vaginitis. The diagnostic panel 960 shown in Figure 9 contains 5 detector elements 962, 964, 966, 968 and 970. Each of these detector elements is adapted to detect one or more of the causes of vaginitis on its own or in combination with one or more other detector elements. The detector element 962 is adapted to detect the pH. The detector element 964 is adapted to detect the presence of amines. Detector element 966 is adapted to detect G. vaginalis. The detector elements 968 are adapted to detect Candida species. The detector elements 970 are adapted to detect Trichomonas vaginalis. The detector elements may be of any suitable shape, and in any suitable arrangement, and are not limited to the row of square-shaped detectors shown. The combinations of detector elements 962 and 964 can *. * > - » _ ^ ___ ^ -1 * * '"used to detect non-specific causes of bacterial vaginosis A previous study of bacterial vaginosis (BV) involved pH combinations of the vaginal fluids of a woman known to have BV with those known from someone who does not have the disease - Gardner, HL, et al., Am. J. Obstet, Gynecol., 69: 962 (1955) All BV-positive women in the study were determined to have a vaginal fluid pH greater than 4.5 and 91% of those women had a vaginal fluid pH greater than 5.0. Subsequent studies have not adjusted the pH threshold to 4.7 In addition to pH, a report by Amsel, R., et al., Am. J. Med. 74 : 14-22 (1983) established three other BV indicators: these are the vaginal fluid homogeneity, the sniff test (alkali treatments followed by an olfactory test to detect the amine smell) and the presence of indicator cells. presence of two of those indicators (pH and amine) corresponds to close to the results obtained when testing the four BV indicators. Preferred pH indicators are bromophenol blue, bromochlorophenol blue, bromocresol green, bromocresol purple, bromothymol blue, bright yellow and nitrazine yellow. A particularly preferred pH indicator is yellow nitrazine, which, when in combination with quaternary ammonium groups, changes directly from greenish yellow to blue over a narrow pH range of about 0.1 pH units as the pH increases, the transition that is centered around a pH of 4.7. a.-t .... »? .......... ^ tAj- _.

The quaternary ammonium groups can be any groups capable of determining a sufficient positive charge to form an ionic attraction with the groups negatively charged in the indicator. Preferred quaternary ammonium groups are lower alkylammonium groups in which the alkyl groups are Ci-C alkyl groups. Trimethylammonium groups are particularly preferred. The sniffing test which is one of the Amsel criteria originated in a study by Pheifer, et al., N. Engl. J. Med. 298: 1429-1434 (1978) which reported the presence of a fish-like amine odor characteristic of the addition of 10% KOH in a vaginal fluid sample from a woman with BV. The odor is caused by the alkaline volatilization of the amine salts found in the vaginal fluid of the woman with BV. The amine test differentiates between amines volatilized by alkali and those that are not volatilized by alkali by incorporating solid alkali accessible to the sample, an indicator accessible to a liquid sample and an indicator accessible only to vapors emitted by The sample in the same device. Therefore the sample is contacted first with the solid alkali, then applied to both indicators one of which undergoes a color change regardless of the presence or absence of volatile amine, and the other a change of color only in the presence of volatile amines . The choice of solid alkali for the sheet that releases gas is not critical and may vary. Alkaline and alkali metal aluminates earth, carbonates and hydroxides can be used.

Frequently, better results will be achieved with the use of either sodium alumionate, sodium carbonate or magnesium hydroxide. Sodium aluminate is particularly preferred. Any indicator that changes color upon exposure to the amines and preferably amines in a fluid sample that would otherwise be acidic can be used. Bromocresol green is an example, and can be used here, as well as in the pH test. Other examples are bromophenol blue, bromocresol purple, bromochlorophenol blue, nitrazine yellow and various other indicators. The detector elements 962 and 964 may comprise the EXAM® pH and Amin FEM test card detectors mentioned herein available from Litmus Concepts, Inc. to detect non-specific causes of bacterial vaginosis, which utilize the technology described in United States Patent 5,910,447. Detector element 960 is adapted to detect G. vaginalis. In 1988 a report by Thomason, and others. { Obstet. Gynecol. 71 (4): 607 (1988)) suggested that bacterial enzymatic activity, specifically the activity of proline iminopeptidase in a vaginal fluid may be a suitable marker for BV. The proline iminopeptidase serves as a hydrolase. The term "hydrolase" is used herein to refer to a catalyst that is capable of separating a compound into fragments through the addition of water. The test is executed by contacting the sample with a _, _____- _ ^ ___________, ........ ..,., _ I l - »-. solid phase conjugate which is susceptible to being divided by the hydrolase, and either during or subsequent to the same, puts the sample in contact with an indicator that undergoes a detectable change to the action of a reporter group which is a portion of the conjugated and is released either partially or completely by the action of hydrolase. The term "conjugate" is used herein to refer to a reporter group coupled with a substrate residue capable of still dividing or decoupling therefrom and in contact with the same. 10 catalytically active hydrolase whose presence is detected. The term "reporter group" or (interchangeably) or "marker group" is used herein to refer to a portion that can be released hydrolytically from the substrate residue by a hydrolase and which, in its free form, can react 15 with an indicator to produce a detectable change. Such reporter groups include, but are not limited to the following: phenols, naphthols, aromatic amines, amino acids, their derivatives and the like. In a particularly preferred embodiment, naphthylamine, its derivatives and analogues are used as the group 20 reporter. If the hydrolase of interest hydrolyzes the conjugate at any point other than the release of the reporter group, the hydrolase itself would be unable to release the reporter group in active form. One or more auxiliary hydrolases that could only act in 25 conjunction with the hydrolase of interest could then be incorporated into the assay to complete the release of the reporter group in L.1 -, .i. ? ..- tY, .. «,. . J- tw-L '"" I¡ ^ ~' * Ai. < -. »« > *. active form. The auxiliary hydrolase or auxiliary hydrolases should therefore be incapable of releasing the reporter group directly from the intact conjugates, although instead they should be able to release the reporter group only from the cleavage product generated by the hydrolase of interest. The following is an example of the reaction sequence used. First, the hydrolase of interest, unable to release the reporter group directly, specifically hydrolyzes one or more bonds in the conjugate, thus releasing a molecular fragment containing the inactive reporter group. Next, the auxiliary hydrolase (or hydrolases) releases the report group by hydrolyzing the bond between the substrate fragment and the reporter group in one or more stages. The total effect of the above reaction sequence is the release of the reporter group only when the hydrolase of interest is present in the sample. To illustrate an implementation of the present invention for detecting proline iminopeptidase activity, the sample is placed in a device containing first and second solid supports, the first solid support which is a laminate of Mylar® polyethylene on which an L-prolyl -beta-naphthylamide, L-prolyl-beta-methoxynaphthylamide of hydroxy-L-prolyl-beta-naphthylamide conjugate is deposited, the second solid support which is a Mylar® polyethylene laminate of which Fast Garnet GBC a chromogenic indicator that undergoes a detectable change to the action of beta-naphthylamine, is deposited. The sample is placed in the * • * - - ___ device in such a way that the sample makes contact with the first and second solid supports so that the beta-naphthylamine released by the proline iminopeptidase activity in the sample is allowed to diffuse through the sample until the second solid support. The Fast Farnet GBC is then observed for a detectable change as an indication of the presence of the enzyme in the sample. The conjugate can be incorporated into a water soluble polymer matrix such as hydroxypropyl cellulose. The Fast Farnet GBC indicator may be indicated in a water insoluble matrix of ethylcellulose containing a penetrant such as manganese chloride. The detector element 966 may comprise in the aforementioned EXAM® G. vaginalis PIP activity test card available from Litmus Concepts, Inc., which uses the technology described in U.S. Patent 5,571,684. The detector element 968 is adapted to detect Candida species. It is known that enzymatically active Candida albicans aspartic protease is present in the vaginal fluid of women with vulvovaginal candidiasis. It is also known that the presence of the enzymatically active aspartic protease in a sample or specimen can serve as a marker in the diagnostic detection of candidiasis. Therefore, a method was developed to detect candidiasis by testing the presence of enzymatically active aspartic protease in a sample. In this method, a sample, for example, vaginal fluid is A "-» - * - * - '-' - • ~~ - comes in contact with a solid support The solid support with which the sample is contacted has a reporter enzyme (ie, a generating enzyme) signal) immobilized therein The reporter enzyme is immobilized on the solid support in such a way that it is released from the solid support to the action of the enzymatically active aspartic protease if the enzymatically active aspartic protease is, in fact, present in the The sample, after being contacted by the solid support, is combined with an indicator.The indicator is any of the chemical species that are susceptible to a visible or detectable change (such as, for example, a change in color) to the action of the reporter enzyme If, after contact with the sample, the indicator undergoes a detectable change, the enzymatically active aspartic protease is present in the sample and, therefore, it can be said that the candidiasis The term "reporter enzyme" or (interchangeably) or "marker enzyme" is used herein to refer to a signal generating enzyme ie an enzyme whose activity causes a detectable change. Such enzymes include, but are not limited to, the following: peroxidases, phosphatases, rhodoreductases, dehydrogenases, transferases, isomerases, kinases, reductases, deaminase, catalases, urease and glucuronidase. Preferred reporter enzymes are peroxidases, such as, for example, horseradish peroxidase. The reporter enzyme is immobilized on a solid support, ________________ an insoluble polymeric material, inorganic or organic matrix, gel, aggregate, precipitate or resin, in such a way that the reporter enzyme is released to the action of the hydrolase whose presence is being tested. Preferred solid supports include, but are not limited to the following: cellulose, agarose, dextran, polyacrylate, polyacrylamide, or its derivatives chitin, sepharose, acrylic oxidized beads, and polymeric dialdehyde, starch, collagen, keratin, elastin, powder bovine leather, bacterial cell wall peptidoglycan, or fragments thereof, nylon, polyethylene terephthalates, polycarbonates and controlled pore glass. Immobilization of the reporter enzyme with the solid support is carried out using conventional methods and procedures known to and understood by those skilled in the art. The term "indicator" as used herein in reference to the method for detecting Candida species refers to chemical species that undergo a detectable change as a result of the reaction or as a result of the completion of the reactions that occur when the hydrolase enzymatically active is present in the sample or specimen. The resulting detectable change is an indication that the enzymatically active hydrolase is present in the sample or specimen. Alternatively, other detection systems can be established with other appropriate enzymes such as analytes and reporter enzymes. Preferred indicators are visual indicators and, in particular, chromogenic indicators, that is, those in which the visible changes are a change in color, including the -_ - .. - 1.,. TO THE. - »-« - * -. • -. ^ -. ---- - • fc. * ~ - color formation in a material other than colorless to the reaction of the reporter or marker enzyme when it is released from the solid support by the enzymatically active hydrolase whose presence is being detected. Alternatively, the reporter enzyme may be able to catalyze the formation of a fluorescent signal, a phosphorescent signal, a bioluminescent signal, a chemiluminescent signal or an electrochemical signal upon release from the solid support by the action of the hydrolase. Additionally, the reporter enzyme may be capable of producing other visible or detectable signals such as, for example, a lump, an agglutination, a precipitation or a purification zone. A wide variety of chromogenic indicators (ie, chromogenes) and other species that have a similar effect can be used as visual indicators with horseradish peroxidase as the reporter enzyme. Preferred chromogenic indicators comprise a hydroperoxidase and a chromogen including, but not limited to, one of the following: guayacan, 2-2'-acino-bis (3-ethyl-benzthiazoline-3-sulfonic acid), tetramethylbenzidine, phenol , 4-aminoantipyrine, and 4,5-dihydroxynaphthalene-2 acid, 7-disulfonic acid. A particularly preferred chromogenic indicator is comprised of a peroxidase and guayacan, a chromogen that is colorless in its reduced state and deep blue in its oxidized state.

The detector element 968 may use the technology described in United States Patent 5,416,003. The detector element 970 is adapted to detect | __ »'Jtá.? 5 Trichomonas vaginalis. A method for detecting Trichomonas vaginalis by testing the presence of enzymatically active thiol protease in a sample is provided, this method comprises: (a) contacting the sample with a solid support, the solid support having a reporter enzyme immobilized in the same in such a way that the reporter enzyme is released to the action of the enzymatically active thiol protease; (b) combining the sample after it has been contacted with the solid support with an indicator, the indicator being one that is susceptible to a detectable change to the action of the reporter enzyme and (c) observing whether the indicator experiences a detectable change, the detectable change which is an indication of the presence of enzymatically active thiol protease in the sample and therefore Trichomonas vaginalis. Optionally, one or more detector elements 962, 964, 966, 968 and 970 can be replaced by a sensor to detect pregnancy. Said detector can use chromatographic strips. for example, in 1988 a new pregnancy test (Clearblue Easy), developed and patented by Unipath, was introduced to the market. The test uses stained microspheres in an interleaved format to give a stage test. To prepare the test, the microspheres stained with dark blue small (•) are first coated with antibody (Abi) for HCG (human chorionic gonadotropin); the microspheres (• -Abi) are dried on a part of a strip of microcellulose; a second antibody (Ab2) for HCG is immobilized on another section of the strip.

In use the strip is moistened at one end with urine. As the urine moves by capillary action, it collects the blue microspheres (• -Abi) and transports them downstream; Any HCG in the urine reacts with Abi in the microspheres (• -Abi-HCG). When the flow reaches the immobilized Ab2-1, the microspheres stained with HCG (• -Abi-HCG) are trapped by Ab2-1 to form a blue line caused by the HCG intercalation (• -Ab? -HCG-Ab2-1) . The blue line indicates a positive pregnancy test. In addition, downstream there is another line of immobilized protein (Ab3-1) which traps • -Abino conjugated as (• -Abi-Ab3-1) (independent of HCG) to form another blue line that acts as a positive procedural control . If the second line is not formed, the test results are invalid.

There are also domestic tests for LH (luteinizing hormone) and similar clinical tests for stage A and Chlamydia. Other companies test individual laboratory analytes using this chromatographic principle for HCG, common infectious diseases, and DAU (drugs for abuse in urine).

The Carter-Wallace home pregnancy test, First Response® uses flat microspheres (~ 1 μm) coated with an antibody for hCG and very few particles (<50mm) coated with antibody for another hCG epitope. When mixed with a urine sample, if the sample contains hCG, the particles are coagglutinated, producing blocks of red color. The mixture is __-_ poured through a filter that traps the red blocks to produce a pink filter. With negative urine, non-agglutinated red particles pass through the filter and do not develop color in them.

Another immunoassay method comprises applying an aqueous solution containing the analyte antigen to one end of a multi-zone test strip device so that the solution moves along the strip by capillary action. The zones are placed so that the solution (a) makes contact first and reconstitutes the dry labeled labeling component comprising colloidal gold conjugated with an antibody specific for said analyte antigen and then (b) contacts and reconstitutes the second biotinylated diffusible antibody specific for said analyte antigen so that a dispersed intercalated reaction product is formed, diffusible. The reaction product diffuses along the strip with the solution and into an area containing the capture component consisting of a latex and avidin complex whose avidin collects the reaction product by means of the reaction with its portion. of biotin. Therefore, the gold particles are collected and concentrated in the detection zone for visual determination.

The technologies allowing multiple analyte assays also of potential use in this invention. These include, but are not limited to microbeads labeled with antibody, Silas (TR), surface analysis or membrane-based biodetectors. -i -.- - .. - ... fa .- * ....- Jad-. i¡_fl ______ - "- '' -. &, ... - ________ ai In practice, a detector array can be placed on a surface to be contacted with an adequate sample Samples include, but are limited urine, saliva, sweat, and vaginal discharge Individual detectors respond to their respective analytes and produce a detectable signal This can be as simple with a change in color index or refractive, or it can involve a change in an electrical signal to current flow through a biodetector membrane.

For example, antibodies of the appropriate hormones can be immobilized on the surface of Silas optical discs by methods known in the art. These discs can be separated and placed in a known pattern on a sensing article, for example, a pantiprotector. Similarly, their antibodies could be immobilized on microbeads and placed in a lateral flow assay device suitable for urine or saliva matrices. Again, multiple reagents can be used in one arrangement by reading all the analytes simultaneously.

Similarly, other analytes can be detected in combination with hormones. These include biomarkers for other conditions of interest, such as infections, osteoporosis, etc. SILAS ™ or SILICON Assay Surfaces Technology developed by Biostar, Inc. of Boulder Colorado, is a proven method for the detection of specific target molecules. The patents of .- ?. . "And. * U > ? -, J-i., ___________ Biostar on this technology include the patents of the United States of North America 5,955,377; 5,869,272; 5,639,671; 5,629,214; 5,541,057; 5,482,830; 5,418,136. This technology based on thin film has been successfully used for the development of diagnostic tests to detect bacterial and viral antigens from the group of streptococcus A, streptococcal group B, Chlamydia, and influenza A and B (optical immunoassay (OIA® )).

The disc consists of a silicon support with an optical coating and a bonding layer. This disc surface technology allows direct visual detection of a physical change in the optical thickness of thin molecular films. This change in thickness is due to the specific capture of an analyte on the surface. When the substrate is added, this binding event is amplified and again increases the thickness of the surface of the molecular thin film. This change in thickness alters the path of reflected light and is visually perceived as a color change. The slight change in optical thickness produces a different visible color change. A positive result appears as a purple dot on the predominantly gold background. When the objective is not present in the sample, the union does not take place. Therefore, the optical thickness remains unchanged and the surface retains the original golden color indicating a negative result.

Therefore, in a first aspect, the SILAS ™ technology is used in the device to detect the amount or presence of - rri-a > . an analyte of interest. The device includes a substrate having an optically active surface that exhibits a first color in response to light impacting it. This first color is defined as a spectral distribution of the light that emanates. The substrate also exhibits a second color that is different from the first color (having the combination of wavelengths of light that differ from that combination present in the first color, or having a different spectral distribution or having an intensity of one or more of those different wavelengths from that present in the first color). The second color is displayed in response to the same light when the analyte is present on the surface.

An "optically active surface" is a surface that participates in the generation of an optical effect so that the light that hits that surface is altered in some way. Said optically active surfaces can be adapted to respond only to polychromatic light (for example white light) but also to monochromatic light (for example laser light, which can be inherently polarized). This technology preferably produces a color signal that greatly contrasts with the previous interference color of the untreated test surface and a reacted surface.

Specifically, this technology uses similar devices in which the substrate has a binding layer formed from a chemical element selected from the group consisting of dendrimers, starting polymers, molecular self-assembling polymer, polymeric siloxanes, and film forming latexes; the substrate itself is formed from a material selected from the group consisting of monocrystalline silicon, an amorphous silicon on glass, amorphous silicon on plastic, a ceramic, polycrystalline silicon, and compounds of those materials; and substrate may have an optical thin film formed from the material selected from the group consisting of silicon nitride, silicon / silicon dioxide compounds, titanates, diamond, zirconium oxides and 10 silicon carbide.

The substrate is selected from the group consisting of glass and plastic, comprising an amorphous silicon layer on its surface, whereby an optically active surface is produced; on the optically active surface includes monocrystalline silicon or 15 metal, the substrate is metal that also has a layer of amorphous silica; a receptor layer that receives the analyte is provided with a binding partner specific for the analyte; the receptor layer is formed from material selected from the group consisting of antigens, antibodies, oligonucleotide, burners, enzymes, 20 bacteria, bacterial cells, bacterial flagellar materials, nucleic acids, polysaccharides, lipids, proteins, carbohydrates, metals, viruses, hormones and receptors of said materials; and the first color of golden appearance and the second color is purple or blue in appearance in view. 25 In another related aspect, this technology refers to a J _ ^ __ -____. - * ..J..A.-.... O..Í ... i. ", __ > .._. Jtei-L - "" - - - - ___. method for detecting an analyte of interest in a sample, by the steps of providing an optical immunoassay device or thin film having a substrate, having an upper surface and a lower surface, and supporting on its upper surface, an antibody layer unlabelled bound to the substrate, at least one layer containing the analyte from the sample, the analyte containing the layer that supports at least one layer having an enzyme conjugate formed in complex with the analyte; contacting enzyme conjugate with a precipitating agent; 10 incubate for a sufficient period to cause precipitation of the product from the interaction of the precipitation agent and the enzyme; and optically measuring the mass change of the enzyme conjugate layer and the unlabeled antibody layer as an indication of the amount of the analyte in the test sample.

Preferably, the enzyme conjugate has an immobilized peroxidase or a complex of antibacterial antibody-horseradish peroxidase; or the enzyme conjugate is alkaline phosphatase and comprises an antibacterial antibody-alkaline phosphatase complex and the precipitating agent is a substrate containing 5-20 bromo-4-chloro-3-indolyl phosphate.

The pantyhose 920 shown in Figure 9 comprises a hybrid top cover comprising a film with openings with a nonwoven material in the form of strips attached to the film with openings along the sides of the pantyhose as described 25 in the patent of the United States of North America 6,004,893, Van __g__j¡ | «_-., ..,» ... "_. . .... -A .... ,, ^ _J __...

Tilburg. The components of the top cover can be joined in any suitable manner, such as in the manner shown in Figure 9 (by a plurality of circular fusion joints placed in a sinusoidal pattern).

The detector elements 962, 964, 966, 968 and 970 may be attached to the surface facing the wearer of the upper cover of the panty protector 924. The detectors may be joined in the region of the pantiprotector corresponding to the location of the wearer's vagina. . The detectors may be joined by any means of attachment or bonding as is known in the art, such as an adhesive. Alternatively, the top cover 924 may comprise at least one opening and the detectors may be joined in the region of the underlying absorbent core corresponding to the upper cover opening or openings.

The detected elements may be of the type of a positive or negative sign to indicate the presence or absence of the test analytes in an amount over a certain threshold as shown in Figures 9 and 9A. Alternatively, the detector element may be adapted to provide a colorimetric indication of the amount of test analytes as shown in the diagnostic panel in Figure 10, and the color darkness on the detector elements may be compared to a comparison diagram. 1090, such as the one shown in Figure 11, which indicates the level of test analytes present. The comparison diagram can be provided in a number of formats _-__ suitable, including but not limited to, the shape of a card that is packed with the item on which the detectors are located, or on the outside of the package.

The detector elements can be covered by a cover 980 to prevent the test reagents in the detectors from coming into contact with the wearer's body, without the test reagents being present. Preferably, the cover 980 is clear and also flexible, so that it will not interfere with the use of the article, if the article is of a type to be used adjacent to the body of the wearer. The cover 980 may be, for example, of any suitable material such as plastic, SARAN® wrap, MYLAR®, or the like. The cover 980 may be openings to allow the body fluids to come in contact with the detectors or may be without openings.

If a cover 980 is used, it may be desirable to provide a fluid transport member, such as a cotton packer strip 982 under and / or on the sides of the detectors to bring the body fluids of interest into contact with the detectors. .

Figure 12 shows a non-limiting sanitary napkin embodiment 1220 containing an illustrative diagnostic panel 1260. The sanitary napkin 1220 shown in Figure 12 also has a plurality of circular fusion joints placed in a quilted pattern on its surface confronting the body. The towel -j i, - .., A *. ,, «, ..-. Xí, Sanitary 1220 also has fins or wings with corrugated in them. However, it should be understood that the present invention can be provided in sanitary napkins having many other suitable configurations.

Figures 13-15 show a non-limiting interlabial device modality 1320 containing an illustrative diagnostic panel 1360. The interlabial device 1320 comprises an upper cover 1342, a rear cover 1338 attached to the upper cover and an absorbent core 1344 positioned between the top cover 1342 and back cover 1338. This embodiment of an interlabial device also includes a handle 1352 to provide the user with a form of attachment to the device for insertion and if removal is desired. As in the case of the other items shown in the drawings, such a device may be in a wide variety of suitable configurations. Figure 16 shows how the interlabial device 1320 can be held by a user for insertion into the space between the user's lips. Figure 17 shows the interlabial device in place with respect to the wearer's body.

The portions of the wearer's body, W shown in Figure 17 are designated as follows: bladder, B, clitoris, C, urethra, U, labia minora N, labia majora, J, vagina, V, vaginal introitus, VI, rectum , A, hymenal ring, H, and large intestine, I. The interlabial device 1320 is inserted so that it is used between the lower lips of the user N, and the labia major J and blocks the - »a. -í t "J- .. - ..-«, ..... vaginal introitus of the user VI without entering the vagina past the hymenal ring H. That is, the interlabial device 1320 is located at least partially in the vestibule joined by the labia minora when the device is in use. Ideally, the interlabial device 1320 is held in contact with a large portion of the inner surface area of the lower lips of the user N, and the labia majora J as possible. This will ensure that the interlabial device 1320 intercepts as many exudates from the user's body as possible.

In the particular embodiment shown the interlabial device 1320 is preferably at least partially retained in place by virtue of the folded configuration which causes the interlabial device to exert a slightly laterally outward pressure on the inner surfaces of the lips 15 minors of the user, the labia majora or both. Additionally, the product is also maintained by attracting the wet lip surfaces naturally to the top cover 1342. Optionally, the top cover 1342 may be provided with a biocompatible adhesive to aid in adhesion 20 of the upper cover 1342 towards the inner surface of the wearer's lips.

In addition, in other embodiments, instead of having a single detector or diagnostic panel 1360 comprising multiple detectors, located centrally on the top cover 25 1342 as shown in Figures 13-16, the interlabial device jj ^ ...? .. - _... -. ,,. ly .. "* xy. 1320 may be provided with detectors that are numerous in other arrangements. In a non-limiting example, the interlabial device 1320 may have separate detectors or diagnostic panels. For example, the interlabial device may be provided with two detectors. A detector may be located towards the front of the interlabial device (for example, to detect the causes of adult incontinence or urinary tract infections), and another may be located towards the back of the device (for example, to detect infections). vaginal). The possibility of locating multiple detectors in several different locations also applies to the other types of absorbent articles described herein. However, in the case of interlabial devices, such an arrangement is considered to be particularly beneficial due to the proximity of the interlabial device to the user's urethra and the vaginal introitus in use. This proximity makes it more likely that the body substance of interest makes contact with the appropriate detector.

In other embodiments, interlabial devices with more than one type or location of sensing device could be sold together as a device to detect more than one condition. In other modalities, more than one of the types of articles described herein could be sold together in the form of a kit to detect more than one condition.

Figure 18 shows a non-limiting buffer modality 1820 containing an illustrative diagnostic panel 1860. The or _M_ _i_k_ > The biodetectors used in the present invention may comprise one or more "proactive detectors". This is especially useful in modalities where the detection of the biologically reactive target analyte precedes the onset of clinically observable health symptoms. As used in this application, the term "proactive detector" refers to a detector that is capable of detecting changes or signals on the wearer's body (i.e., the skin) or on the body substance, i.e., inputs, which are directly related or in a minimum level, they correlate to the occurrence of an event related to health and imminent or potential skin. The proactive detectors may respond to one or more specific inputs as described above, (it is understood that all descriptions that relate to "biosensors 60" may apply to the other detectors used in the articles in the drawings such as those in the diagnosis 960, 1260, 1360 and 1860).

A proactive detector 60 can detect an impending event or detect a parameter that is directly related, or correlates in the minimum way with the occurrence of an impending event particularly a systemic or skin health event or condition (i.e. indications in clinically observable symptoms). An impending event that can be detected or predicted by a proactive detector 60 in the present invention may include diarrheal disease, irritation or burning of the skin (including candidiasis), and / or other types of disease or _dg | _ ^ _ j j_a_____, - «" »- < •« --- - "- - • *. * »- user medical conditions such as parasitic infection. The biological analyte detected may be one or more stages removed from the actual presentation of clinical symptoms. For example, the biosensor can detect potential precursors for the above conditions (eg, faecal contamination of the skin that may precede the extraction of tension proteins which may, in turn, precede clinically observed skin irritation. parameter that correlates to an event is any input that can be measured, the signal such as one or more of the aforementioned potential inputs, which correlate with the occurrence of the event within the structure of the system's reference frame (ie, caused by the waste or by the user.) The proactive detectors 60 in an article can measure one or more different inputs in order to forecast an event, For example, the proactive detector 60 can monitor Candida albicans in feces and bacteria. residual colony on the skin (ie, detect residual contamination) which are signs that may precede the irritation e the skin.

In biodetector modalities where the biorecognition element does not produce an easily visible signal (eg, a color change), the biosensor 60 may include a transducer in communication with the biorecognition element in order to convert the physicochemical signal of the biorecognition element in a signal usable by the user, the - ^ jt care provider or component of the item (for example, an actuator). Illustrative transducers may include electrochemical transducers (including potentiometric, amperometric and conductometric transducers), optical transducers (including fluorescence, bioluminescence, total internal reflective resonance and surface plasmon resonance), thermal transducers and acoustic transducers as is known in the art. A power source, such as a miniature 3-volt clock battery or a thin-film lithium battery can be connected to the biosensor 60 to provide any required power.

The effectiveness of the biosensors of the present invention can be measured with the response factor test described in the test method section below. The response factor describes the relationship of the biosensor response when exposed to the fecal test material compared to the biosensor response when exposed to physiological saline and is useful for determining the sensitivity of the biosensor to determine the sensitivity of the biosensor for analytes biologically active that are expected to be preferentially found in faeces against urine. The biosensors of the present invention preferably have a response factor of at least two, three, or five more preferably and at least 10 and even more preferably at least 20 when exposed to fecal test material. in aqueous solution or test urine having a concentration of one gram of fecal test matter per one gram of physiological saline solution (physiological saline is used herein to represent the antecedent input signal that is present in the majority of natural environments such as aqueous body fluids). Such biosensors are able to clearly distinguish between the presence of fecal matter and the presence of physiological saline with respect to a biologically active target analyte specifically for faeces.

One way to detect stool is to detect skatole, a substance commonly found in fecal material. It has been found that the concentration of skatole in the faeces is approximately 180 micrograms per gram of fecal material considering that the level of skatole in the urine has been found to be substantially lower. The skatole is generally a product of microbiological degradation that originates from the catabolism of tryptophan in the intestinal system.

In a preferred embodiment of a biodetector that detects skatole, the biosensor comprises genetically engineered microorganisms that assimilate skatole and other substances. The assimilation of the specific substances of skatole can be measured, for example, through the consumption of oxygen during the assimilation process. Suitable microorganisms for detecting skatole include Acinetobacter baumannii TO136 (FERM P-12891, Japanese patent publication JP05304947), and Bacillus sp TO141 (FREM P-12914, described in the patent publication ____-___ ... ... "." _ --Bja- Japanese JP05304948). Suitable biosensors including such microorganisms are commercially available, for example, from Institut für Chemo-und Biosensorik in Münster, Germany, under the designation Mikrobielle Sensoren.

If the microorganisms are incorporated into a biosensor, they can be immobilized from the biosensor by known techniques such as crushing, adsorption, entanglement, encapsulation, covalent attachment, any combination thereof or the like. In addition, immobilization can be carried out on many different substrates as is known in the art. In certain preferred embodiments, the immobilization substrate can be selected from the group of polymer-based materials, hydrogels, tissue papers, nonwovens, woven materials and silicon semiconductors.

In certain embodiments, the detector 60, which includes any biosensor modes, may comprise, be placed on or be operatively associated with a microcircuit, such as a silicon circuit, MEMs device (i.e., micro-electromechanical system, or an integrated circuit) . The biosensors based on microcircuit can be known as "biomicrocircuits". Regardless of the type of detector, the microcircuit may comprise a multiplicity of detector components having similar or different sensitivities, kinetic energy and / or target analyte (i.e., labels) in an arrangement adapted to detect different levels or combinations of said analytes. . In addition, each ...-. "..-... .., -, ._.... ^ -.j-». The detector in said arrangement may provide a different type of signal, including those types described herein, and may be associated with different disconnectors and / or controllers. Also, each detector in an arrangement can operate independently or in association with (eg in parallel, combination or in series) any number of other detectors in the arrangement.

The biosensor 60 may be positioned in and / or operatively connected to any portion of a disposable article (eg, diaper 20 of Figure 1), which will be exposed to the inlet that the biosensor is designed to detect. (It should be understood that the full description regarding the biosensors also applies to the items shown in the drawing (s) even though the number of references is used primarily to refer to the article in this description). For the purposes of the present invention, the term "operatively connected" refers to communication means so that the biosensor 60 may signal some portion of the article 20 when the biosensor 60 detects an input. The biosensor 60 may be separated from and operatively connected to another portion of the biosensor 60, another biosensor 60, an actuator, a controller or some other portion or component of the item 20. "Operably connected" may, for example, include such communication means as an electrical connection through a cable or conductor member, by means of a transmitted signal such as radio frequency, infrared or other transmitted frequency communication. Alternatively, the biodetector 60 can L.J, - * "..», ..... - bj - '- * - "*»' *. ^ T ^ jjj be operatively connected by means of a mechanical connection such as a pneumatic or hydraulic connection.

In the diaper shown in Figure 1, the biodetector 60 may be located in the front waist region 36, the rear waist region 38 or the crotch region 37 of article 20, and may be integral with, placed adjacent to, attached a, or comprising a portion of the chassis 22, the top cover 24, the back cover 26, the absorbent core 28, the side panels 30, the leg cuffs 32 with a waist feature 34, a fastening system 40, the edges longitudinal 50 or end 52, etc. In certain preferred embodiments wherein the biological target analyte is associated with bodily waste, the biosensor 60 may be placed in the crotch region of article 20 to maximize the likelihood that the body waste will make contact with the biosensor 60. In other preferred embodiments wherein the biodetector is adapted to detect or measure a biological target agent on the user's skin, the biodetector 60 may be placed on the top cover, the fold, a waist feature, a stool receiving bag, a separator, or any other portion of the article that makes contact with the user's skin during the process of use. In certain embodiments, the biosensor may also be associated with the lotion or with another skin care composition within the article.

The biosensor 60 may be integral with article 20 or may be installed by the caretaker or the user. The biosensor during the course of the use of the article, may also be at least partially separated from the article and may adhere to the user's skin. The biosensor can be fixed permanently or separable (for example, a mechanical fastening system such as Velero ™ or a water soluble adhesive) to a support structure, including adhesive tapes, cellulose or synthetic webs, high nonwoven sponge elements, films, thin canvases, foams and the like. In addition, the biosensor 60 may be contained entirely within the article such as article 20, or may have a receiving portion located in the article so that it will come in contact with the desired entry and another portion such as the transmitting portion located either in the article or outside the article. The biosensor 60 may be external to the article 20 although it is operatively connected to a portion of the article 20 so that the biosensor can detect an input external to the article 20 and provide a signal to a dildo and / or an actuator in some embodiments with the biodetector it may be separate from the article, for example, applied separately to some portion of the user by means of adhesive or other means known in the art, and / or may have one or more separate components of the article.

In some embodiments, means or cleaning elements may be provided to enable the user or caregiver to sufficiently clean the bodily wastes from the biosensor 60 to allow a visual determination or reading of the signal (especially for biodetector modalities that provide said signal). The cleaning element can include a weave (cellulose or synthetic), high nonwoven sponge elements, film, foam, a rigid brush-like element and the like, placed in the article and adapted so that the element can be used for clean the biodetector screen. The cleaning element can be at least partially fixed to a component of the article, such as an upper cover, in proximity to the biodetector 60 through means known in the art. The cleaning means may optionally comprise water or other known cleaning liquid to facilitate cleaning of the user or of the biodetector screen.

In certain preferred embodiments, the article 20 may comprise an actuator. As used in this application, the term "actuator" refers to a device comprising "potential" and means of transforming that potential to execute or activate a "response function". The potential of the actuator may comprise either potential or stored energy or stored material. The actuator may therefore execute or activate a response function by transforming potential energy into kinetic energy or by releasing or supplying a stored material. A "response function" is defined for the purposes of the present invention as a function performed on the body substance, the user, the article or a component - to.-. TO .'....". or components thereof, or the signal for the user or the person providing the care. A component of the body substance may include, for example, moisture, electrolytes, enzymes, volatile gases, bacteria, blood, etc. A user component may also include the skin, genitals, rectum, anal sphincter muscle etc. A component of the article may also include leg cuffs, waist bends or other debris barriers and / or containment components, side panels, ears, a base, an absorbent core, an acquisition component such as a fastening system, the edges longitudinal or end, etc. Potential energy can be stored as mechanical, electrical, chemical or thermal energy. The "kinetic energy" as used in this application, refers to the ability to perform a job or to execute a response function as described above (eg, expansion of a compressed device, rotation of the rotated device, a gel that moves as phase changes, coating or treatment of the skin or stool, inhibition of an enzyme, adjustment of pH, etc.).

The activation of the creation of a three-dimensional structure for trapping bodily substances, for example, involves response functions performed by a component of the article and, generally, on the bodily substances. The capture of bodily substances, the cleansing of the user's skin or the treatment of the skin with a skin care composition, microbial agent, antifungal agent or enzyme inhibitor, by __ »- ... - __._- .aJ. _t_M ___ * _ a _ * _ > ___ > _ ^ _ Ba * - * - - * - * - s example, are response functions performed on the body substances and / or the user. Adjustment of article geometry (in one, two or three dimensions) or physical properties (eg, flexural modulus, geometry, etc.) are examples of response functions that can be executed by the article. The indication of a person providing care and / or the user that an event has occurred, or is about to occur, is also considered a response function for the purposes of the present invention. The signal can be visual, auditory, tactile, electrical, chemical or biological. An actuator of a disposable article can, for example, deliver or deliver a deodorant, enzyme inhibitor, antimicrobial agent, antifungal agent, skin care composition or pH control agent; capture, clean, cover, trap, immobilize, seal, pump or store body waste; or activate the release or creation of a structure or element designed to execute one or more of those functions or any response function on the body substance, the user, the article, or a component thereof.

The actuator of the present invention can release potential energy to execute or activate a response function on the body substance, the user, the article or a component thereof. The release of potential energy can transform the potential mechanical, electrical, chemical or thermal energy into kinetic, mechanical, electrical or chemical energy to execute the response function. The actuators can be activated by a threshold level of one input to release the potential energy to execute a response function or they can continuously respond to an input as described below. For example, a stored foam has stored compressive mechanical potential energy and can provide mechanical kinetic energy when it is released. A rotated foam has stored twisted mechanical potential energy that can provide mechanical kinetic energy, i.e., a rotation, when it is released. In addition, the stored chemical, electrical or thermal energy can be used to release electrical kinetic energy, chemical or thermal mechanics. The actuator of the disposable article, for example, may include one or more of the following: stored lotion, antifungal or antimicrobial agents, stool modification agents, enzyme inhibitors, pH regulators, dyes, pressurized gas, a compressed foam, a rotated foam, a pump, a closed system liquid transport member, an electrically sensitive gel, a pH sensitive gel, a saline concentration gel, etc. The potential energy can be stored in any way sufficient to maintain or restrict it until it is required. Suitable means for maintaining and / or restricting said energy include batteries and / or capacitors, elastic, torsional or compressively tensioned materials or structures in the form of unreacted reagents, and materials capable of performing physical or chemical functions (eg, absorbers, emollients, pH regulators, enzyme inhibitors, stool modification agents; compressed gases, etc.). _ ____, Alternatively, the actuator of the present invention may comprise a quantity of stored material that has the ability to execute or activate a response function on the body substance, the user, the article, or any component or components thereof. In one embodiment, for example, the actuator may release or supply a stored material that performs a response function. In this embodiment, the actuator may be activated by a threshold level of an input to release or discontinuously supply material stored in a given time or may release or supply the material in a continuous manner. The actuator may, for example, include stored lotion, skin care compositions, antifungal or antimicrobial agents, stool modifier agents, enzyme inhibitors, pH regulators, dyes, etc. In certain preferred embodiments, the material may be supplied by an actuator such as an expansion resilient material or a gas released at high pressure, etc.

Figures 2 and 2A illustrate an actuator 90 comprising a compressed resilient material 94, such as a foam, sealed under at least a partial vacuum within a pressure differentiating device 91. A pressure differentiating device, as used herein, is any device or structure that can hold a resilient material in a compressed state (e.g., it can store energy by providing a restricting pressure on a compressed resilient material "- * - '' ''" »» .- -L ?. 94). A "compressed state" is defined as the condition in which a material is maintained at a lower volume than the material would have if it were not restricted and under an applied pressure of zero. With respect to the resilient materials, a compressed state can generally be achieved by applying a pressure to a surface of the material or by other means known in the art. The pressure differentiating device may, for example, comprise a vacuum sealed bag, or stretched materials, such as bands, or elastic or non-elastic strips, 10 bands, films, non-woven materials, thin canvases or foams that restrict a resilient material. Preferably, the compression of the resilient material maintained by the pressure differentiating device 91 can be at least partially reduced (i.e., the compressed resilient material 94 can be expanded at 15 less partially) by means of an activating mechanism. An activating mechanism is any element or device such as a detector, actuator or combination thereof, which responds to an input for effecting equalization in the pressure, in the pressure differentiating device 91 and allowing the material Compressed elastic 94 expands at least partially. Upon release of the compressed material, such as when a biologically active target analyte is detected, the compressed resilient material can expand and deliver the stored material. In some embodiments, it may be advantageous for the actuator 90 25 understand an empty space 96.

The resilient material 94 may comprise any resilient material, including, but not limited to, an EVA foam such as those available from Foamex Corporation of Eddystone, Pennsylvania identified as SIF / 210PP1 or the Aquazone 80A foam, from Sentinel Products Corporation of Hyannis, MA identified as MC1900 EVA 2 lb / ft3, or the HIPE foam as described in U.S. Patent No. 5,260,345 entitled "Absorbent Foam Materials for Aqueous Body Fluids and Absorbent Articles Containing Such Materials "issued for DesMarais et al., November 9, 1993; U.S. Patent No. 5,387,207 entitled "Thin-Until-Wet Absorbent Foam Materials for Aqueous Body Fluids and Process for Making Same" issued to Dyer et al. on February 7, 1995; and U.S. Patent No. 5,625,222 entitled "Absorbent Foam Materials For Aqueous Fluids Made From High Internal Phase Emulsions Having Very High Water-To-Oil Ratios" issued to DesMarais et al. on July 22, 1997. (Each one of the patents identified above are incorporated herein by reference).

In some embodiments of the present invention, the pressure differentiating device 91 may comprise a bag, such as a soluble bag 92. The soluble bag 92 may be soluble in the presence of one or more types of inlet, such as water, urine, fecal enzymes, a pH level, etc., and may have physical and / or chemical characteristics (eg, thickness) that ----- "- -.- --_ - -. ^, -.-- ,. ... - and -» - - -c- - - a- i - can be designed to set a level The threshold of that entry required to dissolve the bag The soluble bag may, for example, comprise a plastic film that is soluble with water such as the PVA films supplied by Chris-Craft Industrial Products, Inc. of South Holland, IL as MONOSOL film M7031, M7030, M8630, M8534, or E6030 or HB Fuller Company of St. Paul, MN as HL 1636 or HL 1669. The thickness of the film, for example, can also be modified to provide a desired activation. The film used can, for example, have a thickness in the scale from about 0.0012 to about 0.0038 centimeters.A HL 1636 film having a thickness of about 0.0025 centimeters, for example, will be activated with a moisture content of approximately 0.049 grams per 6.45 square centimeters.

The actuator may alternatively contain an electrically sensitive gel. Electrically sensitive gels are polymer gel networks that, when they expand at least partially with water, change the volume and / or geometry under the application of current or electric field. For example, certain partially ionized polyacrylamide gels will undergo anisotropic shrinkage of about 50% under weak electric fields (i.e., 0.5 volts / cm) when immersed in acetone and water. Alternative electrically sensitive gels may undergo electrically induced flexion in the presence of water and a surfactant or may experience a ._ ..

Wave oscillating wave motion when subjected to an oscillating electric field. It is considered that local contraction can be induced in a portion of the gel, for example, one side of a gel element, by concentrating the surfactant molecules with positive charge on the negatively charged gel polymer in an electric field. Changing the intensity and / or polarity of the field induces a movement in the gel as one side decreases in length (for example, a gel formed on a strip can be folded). Electrically sensitive gels may comprise variable geometries such as rectangular, circular, rectangular grating patterns etc., in order to provide a valve for releasing a material, allowing a body substance to flow therethrough, preventing a body substance from flowing, encapsulate a body substance, etc., as it changes in volume and / or geometry. An electrically sensitive gel formed in a strip, for example, can be flexed to provide a hollow space available for when electrical activity is detected in the external anal sphincter muscle predictive of defecation or urine.

In Figures 5A and 5B, for example, an electrically responsive gel strip 494 is shown in a circuit in which the fecal moisture can bind the contacts 485 and allow the current to flow into the electrically sensitive gel either by flexing or straightening the strip. Alternatively, an electrically responsive gel 594 formed in a lattice grid pattern ü • »t Í.? and £ and > . £ 595, as shown in Figures 6A, 6B and 6C can be electrically induced to expand or contract when imminent urination is detected to form a valve that allows and / or prevents urine from flowing to another portion of the article. Figure 6A, for example, shows a circuit including a grid pattern of an electrically responsive gel. Figures 6B and 6C further show a microscopic view of a grid in a contracted and an expanded configuration, respectively. An illustrative material is a weakly interlaced PAMPs gel (polyacrylamido-2-methyl-propan sulfonic acid). This type of gel can perform various functions such as the application or supply of a chemical stool treatment agent. Other illustrative electrically sensitive gels are described in U.S. Patent No. 5,100,933 issued to Tanaka on March 31, 1990 and WO 9202005, which are incorporated by reference herein. Alternatively, pH-sensitive gels or gels sensitive to saline concentration that change volume and / or geometry at specific pH or salt concentrations, respectively, can be used as an actuator of the present invention.

The actuator may be positioned in and / or operatively connected to any portion of the disposable article that will allow the actuator to perform a response function on the body substance, the user, the article or a component thereof. In the article 20, for example, the actuator may be located in the front waist region 36, the rear waist region 38, or the crotch region 37 of the article, and may be integral with positioned adjacent to or attached to an undercarriage component. the base 22, the top cover 24, the back cover 26, the absorbent core 28, the side panels 30, the leg cuffs 32, a waist feature 34, a fastening system 40, the longitudinal edges 50, or end edges 52, etc. The actuator may also be contained completely within the article, such as the article 20, may have a portion located in the article and a portion located outside the article 20, or may be completely external to the article 20. An actuator or a portion of a The actuator may be operatively connected to one or more biosensors 60, one or more controllers 80, another portion of the actuator or another portion of the article 20. In addition, the actuator may be integral with the article 20 or may be installed by the person rendering the care or the user.

Article 20 may include a controller. A "controller" is defined for the purposes of this application as a device that receives an input from a biosensor and determines whether one or more actions are taken. The controller can receive a signal from the biosensor 60 and direct the actuator to execute a respective function on the body substance, the user, the article or a component thereof. Alternatively, the actuator can receive the signal directly from the biosensor 60 and execute a response function on the user, the bodily substance, the article or a component thereof. The controller may include materials that undergo chemical or physical change, may be a chemical, mechanical or electrical device that processes information from a biosensor, etc. The controller may include a transducer comprising a multi-layer Langmuir-Blodgett film, in which one or more layers include a biorecognition element. In contact with water, the Langmuir-Blodgett films are known to spontaneously rearrange, resulting in regions with more falls than the original film and other regions that have lower catas. This rearrangement may expose the bio-recognition element to the environment preferably in the presence of water, such as in a bodily substance, which may contain the target biological entity. Therefore, the false positive number can be reduced and the storage life of the biodetector can be extended. Alternatively, an electrical controller that receives signals such as an electrical potential from a electrochemical biodetector can receive and monitor multiple electrical signals and can repeatedly activate the actuator. The co-driver may be integral with the biosensor component, int ral with the actuator component or a separate system component. The controller can be placed in and / or opratically connected to any portion of an article which will allow the controller to receive a signal from the biosensor 60 and provide a signal to the actuator. The article 20, for example, the controller may be located in the waist waist portion 36, the rear waist region 38 or the waist region. ? yi and - J ^ '- rf "* ffi'll_ll crotch 37 of article 20, and may be integral with positioned adjacent to or attached to base 22, or a component of upper cover 24, rear cover 26, core absorbent 28, side panels 30, leg cuffs 32, a waist feature 34, a fastening system 40, longitudinal edges 50, or end edges 52, etc. The controller may be integral with article 20 or may be installed by the person providing the care or the user.The controller may be completely contained within the article, such as article 20, may have 10 a portion located in the article and a portion located outside the article or can be located completely outside of the article 20. The controller or a portion of some controller can be operatively connected to one or more biosensors 60, one or more actuators, another portion of the controller or another portion of the article 20. The controller, for example, can receive a signal from the biosensor 60 and provide a signal to the actuator, for example by means of a radiofrequency (rf) transmission.

Although other structural elements can perform the functions of the biosensor 60, actuator and controller, the functions 20 of the biodetector 60, actuator and / or controller of the present invention do not need to be executed by different structural elements. The functions of the biosensor 60 and the controller, for example, can be executed by the same structural element.

A "response system" is defined for the purposes of 25 this application as a system that includes a biosensor 60 and a 9 actuator acting on the body substances, the user, and the article or a component or components thereof when the biosensor 60 detects the appropriate activation input. Upon detection of a given input parameter, the actuator effects the release of the stored energy or the release or supply of the stored material to execute a response function. For example, when a proactive biodetector 60 that includes a transducer detects an imminent event, the transducer provides a signal to the actuator effecting the release of the stored energy. Upon detecting an input signal before the impending event, an item response system can be activated to prepare for the event or to point out the person providing the care or the user of the impending event. This allows the construction of articles in which the management of the body substance or treatment technology is initially "hidden" or non-obstructive, although it is available at, or just before, the time of need and / or in which the article may provide the person providing the care or the user the opportunity to prepare for an event in advance, (for example, administer a prophylactic treatment to the user in the event of detecting pathogenic microorganisms or residual fecal contamination).

Regardless of the input specifies the biosensor in those modes, you can trigger an activator or execute an action on the item, the user, or the environment to prepare the * - t-®? ^ - * • - »* *" - 'occurrence of the event or provide a signal to the person providing the care that the imminent event is about to occur.If the biosensor 60 comprises a detector system, it can activating an actuator by means of different biosensors and / or signals, or different actuators can be activated by different biosensors or signals, alternatively a biosensor and / or signal can activate multiple actuators.

A response system can respond either in a "continuous" or a "discontinuous" form. As used in this application, a "continuous response system" refers to a response system in which the output is quantitatively dependent on the input quantity, i.e. continuously increasing the input quantities that are required to effect the continuously increasing amounts of the output, or where the output of the response system comprises a passive release of a stored material. A superabsorbent polymer placed in an absorbent core of an article, for example, provides a continuous response to which the output is quantitatively dependent on the amount of the input, i.e., as the quantities of liquid body substances contacting with it increase. the superabsorbent polymer, an increasing amount of the polymer containing that liquid until the capacity of the polymer is exhausted. A stequeometric chemical reaction is another example of a system that has a continuous response for increasing output. To the reaction A + B in excess • C, for example, the i ¿- - ... _ ^ _ t_ «'*. -. ..-, »-» «.-» - amount of excess B converted to C is stoichiometrically and, therefore, "continuously", related to the amount of A available in the system.

A "discontinuous response system" of the present invention refers to a response system having an output function that is essentially independent of the amount of the input beyond a threshold level. For example, when one or more threshold levels and a given input are met, the response system may release all or a predesignated portion of its 10 energy stored or supplied, that is, actively transported, all or a predesignated portion of its stored material to perform a specific response function. In an ideal embodiment of the present invention, the output function f (x) includes a "stage" function as shown in FIG. 3A. 15 In this mode, the rate of change of the output with the increasing input levels (d (outputs) / d (inputs)), that is, the inclination of the first derivative f (x) of the output function f ( x), essentially is preferably zero when the input amount is above or below the threshold level. However, in the 20 threshold level, the range d (output) / d (input) of the change preferably approaches infinity. Therefore, in the ideal discontinuous response, the limit of the function f (x + e) as e? 0 is not equal to the limit of the function f (x + e) as e? 0, that is, lim f (x-e)? lim f (x + e). 25 e? O f * - * lßa? lÍ- ~ M? ,. * -., .. ,, ».. ¿_,". Xi., ... _M_te? _ul_ _a ^ __ _____ f £ However, the present invention recognizes that in the physical world an ideal instant stage change at the threshold level is not necessary and may not even be possible in many cases. In a preferred embodiment it is only necessary that the output function has a virtual stage change with very little change in the input at or around the threshold level of the input. Therefore, the present invention contemplates a discontinuous response system of the present invention having an output function that responds in a sufficiently discontinuous manner in the transition region so that the output function has at least a minimum relative degree of progression in the transition region. While not wishing to be limited to a particular method of describing or modeling a discontinuous system, in a preferred embodiment of determining whether a given output function is executed in a sufficiently discontinuous manner as defined for the purposes of this invention, the inclination of the exit curve at the inflection point is compared with the relative inclination of a line of the first and last points of the transition region. For example, Figure 4A shows an illustrative output function graph f (x) together with aligned graphs of the first f '(x), and second f "(x) and third, f'" (x) derived from the Illustrative output function. The output function f (x) describes the effect of the input (x or I) on the output or the response (R (l)). For the purposes of the present invention, the transition region is defined as the region between the relative maximum R (l?), And the relative minimum R (l2), of the second derivative, f "(x), of the function output, f (x) The relative maximum, R (h) and the relative minimum R (l2), are points at which the third derivative, f '"(x) is equal to zero. The inflection point, l0 is defined as the point in the transition region in which the second derivative, f "(x), is equal to zero, that is, d2R d1R I l = l « The comparison of the inclination of the exit function at the inflection point to the inclination of a line between the first and the last point of the transition region can be described by the equation: = k di I l = l0 (• lt) In the equation dR / dl at the point of inflection it is the first derivative of the output function at that point. The term Alt is the change in the input to the response system between the first \, and last l2, points of the transition region, ie l2-l? and the term • RT is the change in the response of the output function between the first and last points of the transition region, ie R (l2) - R (11). The coefficient k is a proportional constant that describes the relative progression of the tilt of the output function in the point of inflection 10, compared to the inclination of a line between the first and last points of the transition region. In order for the response system to have a discontinuous output function, the proportional constant k must be at least about 2.0, preferably at least about 3.0, more preferably at least about 5.0, and even so more preferably of at least about 10.0, with at least about 100.0 being most preferred.

In certain embodiments, the relative degree of progression in the transition region of a discontinuous response system can also be modeled by a transfer function of a control system having a series of integer, n, first order offsets with a equal time constant. The transfer function of the response system is defined for the purposes of the present invention as the Laplace transform ratio of the output (response variable) to the input (alteration variable). See, for example, Robert H. Perry & Don Green, Perry's Chemical Enqineer's Handbook, Sixth Edition, Chapter 22 (McGraw Hill, Inc. 1984). As shown in Figure 4B the relative degree of progression of an output function can be approximated by the formula: KG (s) = K / (Ts + 1) n in which KG (s) is the transfer function, K is a proportional element, T is the system time constant and n is the integer of first order time shifts. In this model, , L? ..

As the number n increases, the progression of the output function in the transition region increases, and the model begins to approach a discontinuous response system. Certain discontinuous response systems of the present invention can preferably be modeled by the above formula when n is greater than or equal to about 25, with n being greater than or equal to about 50 being most preferred, and n being greater than or equal to approximately 100 which is the most preferred.

As shown in Figure 3A, a response system of The present invention can include an individual threshold level at which the response system can release all of its stored energy to execute a specific response function or can include multiple threshold levels at which the system can release a predesignated portion of its Stored energy 15 to execute one or more specific response functions at each of the threshold levels. In one embodiment, which has an individual threshold level, for example, the response system can release all of its stored energy to execute the full response function when the threshold level is met. In said 20 individual threshold mode, in this example, the discontinuous response system includes a system having two stages such as on or off. When a threshold amount of an entry such as a biological target material is present in the absorbent article, the response system may execute a 25 individual response function on the body substance, the LOL". TlaWall? Fltlr 'Tll'illliiiT,? *. _ j. * J kfaJ, .-., .. -,. ». - ....__, »" user, the article or a component thereof, such as wrapping the body substance away from the wearer's skin or providing a visual signal easily detectable to the user or the person providing care. Therefore, the batch response system can execute a "switch-like" function one at a time that changes from one state to another in the presence of an entry threshold level.

Alternatively, as shown in Figure 3B, the response system may have multiple threshold levels in which when each threshold level is met the system may release a certain "quantum" of energy or supply a certain amount of material to execute a specific response function. In this modality, when each threshold level is met, an equation of the complete response function can be executed and / or different independent response functions can be executed in response with different threshold levels being met. For example, a response system can monitor a faecal enzyme and when each level of threshold enzyme is met it can supply an equal or different amount of inhibitor or enzyme or lotion inhibitor, or supply a pH regulator at the first threshold level. and executing another response function such as supplying an amount of enzyme inhibitor or inhibitors at the second threshold level. In each transition region, the response system essentially responds to the same transition region in the individual threshold mode described above.

In addition, a response system can monitor multiple inputs such as one or more pathogenic bacteria and / or one or more faecal enzymes and execute one or more response functions when the threshold levels of different inputs are met or a response function can be executed only when two or more of the threshold levels of the different entries are met. Therefore, a controller can monitor multiple different inputs and execute a different response function when the threshold level of the different inputs is met. Alternatively, the controller can execute a logical OR gate type function such that a response function can be executed when one or more threshold levels of the multiple inputs is met. The controller may also execute a logic-like bridge type function so that a response function may be executed when each threshold level of two or more different inputs are met.

The response response system may also comprise a "closed cycle" or an "open cycle" system. A "closed cycle" system which also referred to as a "feedback control cycle" system includes a different biosensor 60 and biocomponent of the actuator and performs a response function to the input. In some preferred embodiments, the system may also use a detection or measurement of an element or parameter of the output condition as at least one actuation of the response function that is executed Ii? á.Áil? ..- i ... l * ± C * »&t Jalaa- .. -l r-il-il ^ * - - *» - * - r > - * 'lu if-Wii-i at the entrance. The output condition can be the state of the input condition after the actuator has the opportunity to execute a response function on the input condition. The response function can be executed when the exit condition reaches a threshold level, or it can be executed only when the exit condition and one or more other conditions are met. The drive over the inlet may include acting on the detected element, for example detecting a microorganism and acting on the microorganism, or may include acting on a composition of which the detected element is an integral component, for example, detecting a fecal bacterium and acting on the fecal mass or residual stool on the user's skin. As described above, a feedback control loop system includes at least two distinct components: the biosensor 60 and the actuator. The biosensor 60 detects an event, or a parameter associated with that event. The actuator receives a signal and executes a response function on the output condition detected by the biosensor 60. The feedback control cycle may further include a controller. In this case the biosensor 60 can provide a signal to the controller, and the controller can direct the actuator and execute a response function on the input condition. The controller can be a separate component of the response system or the controller function can be executed by the biosensor 60 and / or the actuator.

, J ... A & _jfc. _fcJ ___ i t The feedback control cycle can be "without modulation" or "modulation". In a "no-modulation" feedback control cycle response system the response system acts as a one-time switch in which the actuator executes an input response function when the threshold level of the output condition is comply For example, the biodetector 60 can detect the presence of or measure the concentration of a specific pathogenic microorganism, and the actuator can signal the person providing the care of a potential incipient infection. In this example, the actuator acts on the input detected by the biosensor 60.

A "modulated" feedback control cycle includes a biosensor 60, an actuator and a controller. In a feedback control cycle with modulation the output condition is monitored constantly or repeatedly, and the controller directs the actuator to execute the response function on the input in order to maintain the output condition at a desired fixed point or within a desired range or to provide a continuous measurement of the level or concentration of the target biological analyte.

However, an "open cycle" system is a system that responds to the input to execute a response function without the use of feedback ie the output has no effect on the detected input that enters the system. An open cycle system can include a response system that has a _j | _ ^ _ ^ _ ^ _ j__? tsi ^ .YiJk individual device that performs the functions of both the biosensor 60 and the actuator or may have a biosensor 60 and actuator components in which the actuator acts on more than the input. A superabsorbent polymer placed in an absorbent core of a disposable absorbent article, for example provides an open cycle response since the polymer only includes a single device that performs the functions of the biosensor 60 and the actuator. Alternatively, an open cycle response system may include a biosensor 60 that detects a body substance or a component of a body substance, and an actuator that performs a response function in a continuous or discontinuous fashion over some other than the detected input or the biodetector 60.

The present invention includes response systems that provide a continuous or discontinuous response, either open cycle or closed cycle. Other response systems are described in United States Patent Application No. 09 / 106,424 entitled "Disposable Article Having a Discontinuous Responsive System" filed July 29, 1998 (Case Number P &G 7197); 09 / 107,563 entitled "Disposable Article Having A Responsive System Including A Feedback Control Loop" filed on June 29, 1998 (Case No. P &G 7198); and 09 / 106,225 entitled "Disposable Article Having a Responsive System Including A Mechanical Actuator" filed on June 29, 1998 (Case No. P &G 7199), each of which is incorporated in the , 1 I, 05 present by reference.

An example of a diaper 20 of the present invention may include a response system that includes a biosensor 60 as shown in Figure 1 and an actuator as shown in Figure 2. In this embodiment, the biosensor 60 may comprise a transducer operatively associated with a biorecognition element adapted to detect E. coli in feces. Upon the specific detection of an E. coli threshold level by the biorecognition element, the transducer signals the actuator with an electric current. The article shown in Figure 1 includes an actuator comprising a compressed resilient material 94 vacuum sealed under a water soluble film 91, as shown in Figure 2 (eg, a PVA film). Upon receipt of the appropriate signal from the biosensor 60, the actuator can close a switch, for example it can release a small amount of stored water to contact and dissolve the water soluble film 91. This results in the release of stored mechanical energy in the compressed foam. The resilient material 94 expands one way a separator to provide an empty volume for the incipient stool. Alternatively, the closure of the switch may additionally release an antimicrobial to control E. coli and / or a visible dye to signal the presence of E. coli to the user or caregiver. In another embodiment, the response system may include an actuator that alerts the caregiver or user and an impending event such as a diarrheal infection or skin irritation (e.g., candidiasis).

TESTING METHOD Response Factor Test: With the response factor test as described herein, the response in a quantitative detector as a reaction of an exposure to a specific substance or composition can be measured.

Specific substances or compositions for which this test is suitable include: faecal test material in aqueous solution having a concentration of one gram of faecal test material per one gram of physiological saline; Fecal test material in test urine solution at a concentration of one gram of fecal material per one gram of test urine solution; urine test solution; an escolto solution in physiological saline solution having a concentration of 180 micrograms of skatole per gram of physiological saline; physiological saline solution.

All measurements are carried out at body temperature (37 ° C). The method includes the following stages in the following order: 1) Record the quantitative response of the detector after the - > * .i.-_- a ..... -, _-... ____ ^ _____________________ | __ exposure to physiological saline solution for 24 hours. The previous answer is the maximum registered response. 2) Expose the detector to the specific substance or composition. 3) Record the quantitative response of the detector while the detector is exposed to the specific substance or composition for 24 hours. The response of the substance is the maximum recorded response.

The response factor is obtained by normalizing the response of 10 the substance with the previous response. In the case that the response factor is less than one, the reciprocal value of the response value is reported as the response factor (that is, the response can be inversely correlated with the input).

The descriptions of all the patents, as well as the 15 corresponding published foreign patent applications and the publications mentioned through this patent application are incorporated by reference thereto. However, it is not expressly accepted that any of the documents incorporated by reference present, teach or describe the 20 present invention.

While the particular embodiments and / or individual features of the present invention have been illustrated and described, it would be obvious to those skilled in the art that they can make other changes and modifications without departing from the spirit and scope of the invention. For example, although aspects of the present invention are illustrated and described with respect to a disposable diaper, the present invention is not limited to this embodiment. The present invention can also be used as, for example, in articles that are applied directly to a user (eg, to the user's perianeal regions) prior to the application of a disposable diaper or in place of a disposable diaper, in a diaper of training, a diaper insert, a sanitary pad, a tampon, etc. Furthermore, it should be evident that all combinations of such embodiments and features are possible and may result in preferred embodiments of the invention. The present invention may also include portions of the articles described herein that are useful independently of other features described herein. For example, the present invention may also include sensors and sensors and methods of preparing said sensors and detectors and methods of using said sensors and detectors, whose sensors and detectors are used for a particular purpose that has not been previously known, regardless of if it is in an article of a specific type and regardless of whether they are used alone or in the context of a diagnostic panel with other sensors. Therefore, the appended claims are intended to cover all such changes and modifications that are within the scope of this invention. t, i i '.j l.y -., .. U, - - - - - •. *.-aM & = _ fc = Í

Claims

CLAIMS 1. An article containing a detection device characterized in that it comprises: a biosensor that includes at least one biorecognition element, the biodetector that is adapted to detect a target biological analyte in bodily substances, or in or through the skin of the user, wherein the article is selected from the group consisting of: a diaper, a training underpants, a waste bag, a feminine hygiene device, a patch, a disposable handkerchief, a disposable towel, a paper bath tissue, and a liquid collection device.
2. An article ading to claim 1 of a type to be used by a user, the disposable article comprising a diagnostic panel for detecting biological analytes in body substances or on or through the skin of a user, the diagnostic panel including: at least a first biodetector and a second biodetector, the first biodetector adapted to detect at least one first biological target analyte and the second biodetector that is adapted to detect at least one second target biological analyte which is different from the first target biological analyte.
3. An article ading to claim 1 or 2, characterized in that the biosensors include biorecognition elements comprising biologically reactive agents. ** • * '- J * - • * yj ^
4. An article ading to any of the preceding claims, characterized in that at least one biodetector is selected from the group of: a biocatalytic biodetector and bioaffinity biodetector.
5. An article ading to claim 4, characterized in that the bioaffinity biodetector is selected from the group of: a biodetector based on a chemoreceptor and an immunodetector.
6. An item in adance with any of the 10 previous claims, characterized in that at least one biorecognition element is selected from the list that includes: (a) an enzyme or enzyme sequence; an antibody; DNA; an organelle; a membrane receptor protein; a membrane 15 natural or synthetic; viable or non-viable bacterial, plant or animal cells; at least a portion of a nervous group; at least a portion of a detector organism; or (b) Acinetobacter baumannii TO136 and Bacillus s TO141; and (c) the biorecognition element that is placed Preferably on a substrate selected from the group of: polymer-based materials; hydrogels; tissue papers; non-woven materials; woven and silicon semiconductor materials.
7. An article ading to any of the preceding claims, characterized in that the biodetector 25 detects target biological analytes selected from the following group: pathogenic bacteria, colony bacteria, viruses, _Í¡¡_ _ÍJ_t_Í_i_n - itt go r H t-thi p m, m tí-i n parasites, bacterial toxins, fungi, enzymes. An article in adance with claims 2, 3, 4, 5, 6, or 7 characterized in that at least one of the following properties applies to the diagnostic panel and the biosensors included in the diagnostic panel: (a) the diagnostic panel is adapted to detect pathogenic causes in diarrhea; (b) the first and second biosensors are each adapted to detect one or more viral causes of diarrhea and to provide an indication of the presence of one or more viral causes for the user, a caregiver or a health professional , and a viral cause that preferably comprises at least one of the following group: rotavirus, astrovirus, calcivirus, adenovirus, and Norwalk virus; (c) the first and second biosensors that are each adapted to detect one or more bacterial causes of diarrhea and to provide an indication of the presence of one or more bacterial causes to the user, a person providing care or a health professional, and bacterial causes that preferably comprise at least one of the following group: EPEC strains, ETEC, EHEC, EIEC, EAEC, Campylobacter jejuni, Vibrio cholerae, Campylobacter jejuni, Vibrio cholerae , and Shigella, including S. sonnei and S. flexneri. (d) the first and second biosensors that are each adapted to detect one or more pathogenic causes of diarrhea and to provide an indication of the presence of one or more ? &Jk. * ~ á. ntLt * yí ....-- .-- .. .. ... "- * - • .-« - • * • - -'- »- - -" * - - - «~ > mmWBk causes the user, a caregiver or a health professional (e) the first biosensor that is each adapted to detect at least viral cause of diarrhea and the second biodetector is adapted to detect at least bacterial cause of diarrhea, or (f) the first and second biosensors are each adapted to detect or more protozoal causes of diarrhea and to provide an indication of the presence of or more causes to the user, a person providing care or a health professional 9. An article in accordance with claim 2, 3, 4, 5, 6, 7, or 8 having at least of the following additional features: (a) at least of the first or second biosensors further comprising a transducer, wherein the transducer is preferably selected from the group that in It includes electrochemical, optical, chemical, and acoustic transducers, where the transducer preferably signals only when the target biological analyte is above a predefined threshold level; (b) the article further comprises a cleaning element for at least of the first or second biosensors; (c) at least of the first or second biosensors is attached to a support element wherein the support member preferably adheres to the wearer's skin; (d) at least of the first or second biosensors is t ~ - ~ -.- ~.-U __, __________ ii¡ ___ á_ia_ife ___ ___ separable from the article; (e) the article further comprises an actuator that performs a response function of at least of the first or second biosensors detects a target biological analyte and the response function is preferably a signal to a carer or the user, wherein the actuator preferably transforms a potential energy to execute the response function, the potential energy which is or more selected from the group of mechanical energy, electrical energy, and chemical energy; (f) the article further comprising a receiver, wherein the receiver is preferably integral with the article; or (g) the article further comprises a transmitter. 10. An article for detecting the presence of vaginal infections or infections according to claims 1, 2, 3, 4, 5, or 9. 11. The article according to claim 10, characterized in that the biosensor detects several specific types. of bacteria can be the cause of bacterial vaginosis including the species Gardnerella vaginalis, Prevoteila bivia, Bacteroides, and the species Mycoplasma hominis, and Mobiluncus. 12. An article to detect the presence of vaginal infections characterized because it comprises: a diagnostic panel that is adapted to detect non-specific types of bacteria that may be the cause of bacterial vaginosis, ... wherein the article is selected from the group consisting of: a feminine hygiene device, a patch, a disposable handkerchief, a disposable towel, tissue for bathroom and a liquid collection device. 13. The article according to claim 12, characterized in that the diagnostic panel detects the pH of the body fluid and the presence of amines in the body fluid. 14. The article according to claim 10, characterized in that the target biological analyte is indicative of the presence of at least of the following: yeast infections, a sexually transmitted disease, and Trichomonas vaginalis. 15. An article according to any of the preceding claims, wherein at least biosensor: is provided on the side facing the body of a feminine hygiene device; and comprises at least detector element that is covered with a cover element, wherein the cover element is preferably flexible. 16. The article according to claim 15, further comprising a cotton packing element adjacent to said at least sensing element for bringing the body substances into contact with at least sensing element. 17. An absorbent interlabial device having a body contact surface and comprising a core J? ": absorbent jteaai-i, the interlabial absorbent device characterized in that it has at least two detection devices placed in separate relation on the surface of the body contact of the interlabial device where one of the detector devices is capable of detecting a substance in the urine, and at least one of the detector devices is capable of detecting a substance in menstrual discharges. • _j_t__h_ ^ u_ i • - nr - ^ * RESUDEN A disposable article to be adjusted to a user and other types of articles having a detection device, such as a diagnostic panel that can, in a set of modalities, include at least one biosensor, each one including at least one an element of biorecognition. The biodetector is adapted to detect a target biological analyte in body substances and on / or through the skin of the user. The diagnostic panel may be adapted to determine the physical condition or welfare state of a mammal, or the cause of a particular disease state, such as diarrhea, vaginal infections, sexually transmitted diseases ("STD's") and other diseases, and point out the person who cares, the user or an actuator of the occurrence. Examples of physical conditions of the welfare state include, but are not limited to, ovulation and the onset of menstruation.