CZ20004751A3 - Disposable article having bodily waste component sensor - Google Patents

Abstract

The present invention is directed to a disposable article that comprises a sensor adapted to detect one or more specific biological, health and/or nutrition markers in the wearer's feces. The article may also signal the caretaker, the wearer, or an actuator of the occurrence.

Description

Disposable product equipped with body waste sensor

Technical field

The invention relates to a disposable product, in particular to a disposable product comprising a biological recognition element which detects the presence of microorganisms and / or other biomolecules in body waste and / or comprises sensors adapted to detect and / or measure feces components, while these sensors are useful as health and nutrition status indicators.

BACKGROUND OF THE INVENTION

At present, disposable products, such as diapers, adult incontinence products, sanitary napkins and tampons, are used extensively in particular to care for the hygiene of children and toddlers, as well as incontinence adults, as a means of retention, isolation and drainage physical waste. In general, these products have replaced underwear which has been used several times after washing, while the reliability of the disposable products and their comfortable wearing are appreciated for single use products. Disposable products respond to baking and wetting by absorbing or retaining body wastes placed on the product. Some disposable products also signal a burn, wetting or ejection of waste as soon as it occurs (humidity indicators, temperature changes detected). Other absorbent articles known in the art include chemically reactive means for detecting various substances in the user's waste, for example pH or ions, for example in urine. In particular, none of these products detect target potential pathogenic microorganisms, such as bacteria, viruses, fungi, and parasites (protozoa) and / or related biomolecules, all of which require a high degree of selectivity (sensitivity) and sensitivity over purely chemical substances. in particular, it does not detect chemical excrement components that would act as health or nutrient identifiers. Furthermore, these products do not predict when a health or nutritional event may occur, nor even indicate to the user or carer the requirement for prophylactic or rehabilitation action before the appearance of clinically observable symptoms.

SUMMARY OF THE INVENTION

The disposable article intended to be attached to a user's body comprises: a biological sensor (biosensor) comprising at least one biological recognition element, wherein the biological sensor (s) are

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- said biosensor adapted to detect biological analytes in body waste or on the user's skin. A disposable article intended to be attached to a user's body includes: a sensor adapted to detect health indicators (markers) or nutrition indicators in body waste or on the user's skin.

Overview of the drawings

Giant. 1 is a plan view of an article made in accordance with the present invention in a planar state and with portions of the structure cut off so as to more clearly show the construction of the article being a diaper; FIG. 2 is a perspective view of a device according to the invention Fig. 2A shows a section taken along line 2A-2A in Fig. 2.

Fig. 3A illustrates the ideal output function of the discontinuous sensitive system of the present invention, with one threshold level (value); Fig. 3B illustrates the ideal output function of the discontinuous sensitive system of the present invention, with several thresholds; Fig. 4B illustrates a transmission function of a control system with a first order delay series having the same time constant; Figs. 5A and 5B illustrate an embodiment of a sensitive system according to the present invention which includes 6A, 6B, 6C illustrates another embodiment of a responsive system of the present invention that includes an electrical responsive gel; FIG. 7 is a perspective view of an embodiment of the present invention with a waste bag; FIG. view of absorbent product with waste bag

DETAILED DESCRIPTION OF THE INVENTION

As used herein, the term "absorbent article" refers to a device that absorbs and retains body exudates, more particularly to devices that are positioned against and in the vicinity of a user's body where it absorbs and retains various exudates expelled from the user's body. The term "disposable" has been used to describe absorbent articles that are not expected to be disposable. ······ Washed or otherwise treated before being reused as an absorbent article (after one use, for example, they are recycled, composted and otherwise treated according to environmental requirements). (The term "disposable" used means that the element (s) is formed (attached and positioned) at a particular location or position, as a unitary structure with other diaper elements, or as a separate element attached to another diaper element). The term "attached" as used herein includes an arrangement in which an element is directly attached to another element by attaching the element directly to another element, and further comprising an arrangement in which the element is indirectly attached to another element by attaching the element to a spacer then connects to another element. The term "unitary" absorbent article refers to absorbent articles that are formed from individual parts joined together to form a coordinated entity, such that the articles no longer require additional handling parts, such as separate holders and bags. A preferred embodiment of the absorbent article of the present invention is a single use disposable absorbent article, for example, the diaper shown in Fig. 1. The term "diaper" refers to an absorbent article typically worn by children and incontinence sufferers on the lower torso. The present invention can also be applied to other absorbent and non-absorbent articles such as incontinence panties, incontinence underwear, absorbent pads, diaper holders, disposable bed liners, colostomy bags, sanitary napkins, tampons, wipes, disposable towels, bibs, water and oil absorbent products, spillage bags, desiccant bags, disposable mops, disposable bandages, disposable medical linen, disposable plates and cups, food preparation and cutting boards, therapeutic packaging and scarves, disposable heating pads, and the like.

Giant. 1 is a plan view of the diaper 20 of the present invention in a flat state and with portions of the structure cut away to better illustrate the construction of the diaper 20. The portion of the diaper 20 facing the user's body is oriented toward the viewer in the figure. According to Fig. 1, the diaper comprises a liquid pervious topsheet 24, a liquid impermeable backsheet 26, an absorbent core 28 that is disposed between at least a portion of the topsheet 24 and the backsheet 26, further comprising side panels 30, spring thigh cuffs 32, and The diaper in FIG. 1 includes a first waist region 36, a second waist region 38 facing the first waist region 36, and a crotch region 37 that is located between the first waist region and the second waist region. The circumference of the diaper 20 is defined by the outer edges of the diaper 20 in which the longitudinal edges 50 extend generally

Parallel to the longitudinal centerline 100 of the diaper 20, and wherein the end edges 52 extend between the longitudinal edges 50, generally parallel to the transverse centerline 110 of the diaper 20.

The diaper body 22 includes a diaper main body 20. The body 22 comprises at least a portion of the absorbent core 28 and an outer cover layer comprising a topsheet 24 and a backsheet 26. If the absorbent article comprises a separate holder and insert, the body 22 generally includes a holder and insert. (For example, the holder may include one or more layers of materials forming the outer skin of the article and the insert may include an absorbent assembly consisting of a topsheet, a backsheet and an absorbent core. In these cases, the holder and / or the insert may include a fastener that is used to keeping the liner in place when using the product). In uniform absorbent articles, the body 22 comprises a diaper main structure with other added portions to form a complex diaper construction. While the topsheet 24, the backsheet 26, and the absorbent core 28 can be assembled in a variety of known configurations, a preferred diaper arrangement is disclosed in U.S. Pat. U.S. Patent 3,860,003 issued to Contractible Side Portions for Disposable Diaper Disposable Diaper Side Parts for a Disposable Diaper, in the name of Kenneth B. Buell, January 14, 1975, U.S. Patent 5,151,092, issued to Buell, September 9, 1992; US No. 5,221,274 issued to Buell on June 22, 1993 and U.S. Pat. No. 5,554,145 entitled " Absorbent Article With Multiple Zone Structural Elastic -Like Film Web Extensible Waist Feature " Roe et al., Sep. 10, 1996, in the US U.S. Patent 5,569,234 entitled "Disposable Pull-On Pants" issued to Buell et al. on Oct. 29, 1996, U.S. Pat. No. 5,580,411 entitled "Zero Scrap Method For Manufacturing Side Panels For Absorbent Articles", issued to Nease et al. on Dec. 3, 1996, and U.S. Pat. U.S. Patent Application entitled "Absorbent Article With Multi-Directional Extensible Side Panels" issued to Rob les et al. on August 20, 1997, the patents incorporated herein by reference .

The backsheet 26 is that portion of the diaper 20 that is disposed adjacent the garment facing surface 45 of the absorbent core 28 that prevents absorbed and retained exudates in the core from contaminating articles that come into contact with the diaper 20, e.g. . The backsheet 26 may be attached to the topsheet 24 of the absorbent core 28 or any other diaper member 20 by any fastening means known in the art. Suitable backsheet films include films such as the films of the backsheet. • · · ·· ·· ···

-5 manufactured by Tredegar Industries lne. of Terre Haute, Ind., and are sold under the trade names XI5306, XI0962 and XI0964. Other suitable backsheet materials may include breathable materials such as woven fabrics, nonwoven fabrics, composite materials such as film coated nonwoven fabrics and microporous films manufactured by Mitsui Toatsu Co., Japan under the trade name ESPOIR NO of EXXON Chemical Co. , of Bay City, TX., under the designation EXXAIRE, or monolithic films produced, for example, by Clopay Corporation, Cincinnati, OH, under the name HYTREL blend PI8-3097. Such breathable composite materials are described in more detail in PCT application WO 95/16746 published June 22, 1995 on behalf of E.I. DuPont, in U.S. Patent 5,865,823 issued to Curro on Feb. 2, 1999, U.S. Pat. No. 5,571,096 issued to Dobrin et al. on November 5, 1996. These documents are given for comparison.

The backsheet, or any portion thereof, may be resiliently extensible in one or more directions. In one embodiment, the backsheet 26 may comprise a structural, as if resilient ("SELF") thin fabric. A structural, resilient, thin fabric is an extensible material that exhibits a behavior similar to the elastic behavior in the direction of elongation without the addition of a resilient material. SELF webs suitable for the present invention are described in U.S. Pat. No. 5,518,801 entitled "Web Materials Exhibiting Elastic-like Behavior" issued to Chappell et al. on May 21, 1996. In alternative embodiments, the backsheet 26 may include elastomeric films, foams, strands and combinations of these or other materials with nonwovens or synthetic films.

The topsheet 24 is typically a loose, soft, non-irritating layer. A suitable topsheet may be manufactured from a wide range of materials, such as porous foams, reticulated foams, apertured plastic films, or woven and nonwoven fabrics of natural fibers (wood or cotton fiber), or synthetic fibers (polyester or polypropylene fibers). ) or combinations of natural and synthetic fibers. If the topsheet comprises fibers, the fibers may be spun, carded, wet-laid, meltblown, water-jet-braided, or made by other methods known in the art. One suitable topsheet 24 comprises a staple long polypropylene fiber fabric manufactured by Veratex, Inc, and the Division of International Zip Company, of Walpole, Massachusetts, under the designation P-8.

Suitable formed topsheets are described in U.S. Pat. No. 3,929,153 entitled "Absorptive Structures Having Tapered Capillaries", issued to Thompson on December 30, 1975, U.S. Pat. Patent · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

No. 6,324,246 entitled " Disposable Absorbent Article Having A Stain Resistant Topsheet " issued to Mullane et al. On April 13, 1982; No. 4,342,314 entitled " Resilient Plastic Web Exhibiting Fiber-like Properties " issued to Radel et al. on Aug. 3, 1982, U.S. Patent 4,463,045 entitled " Macroscopically Expanded Three " Dimensional Plastic Web Exhibiting Non-Glossy Acceptable Surface and Cloth-Like Tactile Impression (issued on June 31, 1984, Ahr et al.) in the US No. 5,006,394 entitled "Multilayer Polymeric Film", issued to Baird on April 9, 1991. Other suitable topsheets 30 are made in accordance with U.S. Pat. U.S. Patent Nos. 4,609,5018 and 4,629,643 issued to Curro et al. on Sep. 2, 1986 and Dec. 16, 1986. The films thus formed are available from The Procter & Gambia of Cincinnati, Ohio as J & RIWAVE ' and Tredegar Corporation. of Terre Haute, Indiana as “CLIFF-T”.

Preferred is a topsheet 24 made of a hydrophobic material, or a treated material to hydrophobic material, to isolate the user's skin from the fluids contained in the absorbent core 28. If the topsheet is made of a hydrophobic material, then at least the top surface of the topsheet 24 it is made hydrophilic so that the liquid can be transferred more rapidly through the topsheet. The topsheet 24 may be considered a hydrophilic layer when treated with a surfactant sprayed onto the topsheet material 24, or by immersing the material in the surfactant. This modification is discussed in more detail in U.S. Pat. U.S. Patent 4,988,344 entitled " Absorbent Articles with Multiple Layer Absorbent Layers " issued to Reising et al. on Jan. 29, 1991; U.S. Patent 4,988,345 entitled "Absorbent Articles with Rapid Acquiring Absorbent Cores", issued to Reising on January 29, 1991. A more detailed description of suitable methods for incorporating surfactants into the topsheet can be found in US Statutory Invention Registration No. H1670, issued to Aziz et al., All references cited are incorporated herein by reference.

Any portion of the topsheet 24, or other component of the article, may be coated with a lotion layer as is conventional in the art. Examples of suitable lotions are given in U.S. Pat. No. 5,607,760 under the title "Disposable Absorbent Article Having A Lotioned Topsheet Containing an Emollient and Polyol Polyester Immobilizing Agent" · · · · · · · · · · · · · · · · · ······· · · · · · · · · · · · · · · ·

-7 (disposable absorbent article with lotion-coated topsheet and containing a plasticizer and a polyol-polyester immobilizer) ", issued to Roe on March 4, 1997, in U.S. Patent 5,609,587 entitled" Diaper Having A Lotion Topsheet Comprising " A Liquid Polyol Polyester Emollient And An Immobilizing Agent ", issued to Roe on March 11, 1997, U.S. Patent 5,635,191 entitled" Diaper Having A Lotioned Topsheet Containing A Polysiloxane Emollient (diaper comprising a topsheet coated with lotion and containing a polysiloxane emollient) issued to Roe et al. On June 3, 1997, and U.S. Patent 5,643,588 entitled "Diaper Having A Lotioned Topsheet." (lotion-coated diaper) 'issued to Roe et al. on 1 July 1997. Pl Either water can function alone or in combination with another substance as a hydrophobizing treatment agent. The topsheet may also be treated with an antibacterial, as exemplified in PCT publication WO 95/24137 entitled " Absorbent Articles Containing Antibacterial Agents in the Topsheet for Odor Control " issued to Theresa Johnson on September 14, 1995. The topsheet 24, the backsheet 26, or any portion of the topsheet or backsheet may be embossed and / or matt to create a fabric-like appearance.

The topsheet 24 and the backsheet 26 may be joined together as well as the absorbent core and any other element of the diaper 20 by a fastener known in the art. For example, the bonding means may comprise a uniform continuous adhesive layer, a patterned adhesive layer, a plurality of separate lines, spirals or adhesive points. The bonding means may further comprise a thermal bond, a pressure bond, an ultrasonic bond, a dynamic mechanical bond, and any other suitable bonding means or combinations of these means known in the art.

The absorbent core 28 may include 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 variety of sizes and shapes (e.g., rectangular, watch-shaped, T-shaped, asymmetric, etc.) and can include a wide variety of absorbent material commonly used in disposable diapers and other absorbent articles, wherein said material may be ground cellulose, known as air felt. Examples of other suitable materials include creped cellulosic fillers, polymers, and polymers. · • · · ··········

Meltblown melt including chemically stiffened, modified or crosslinked cellulosic fibers, fine fabric including fine drapes and fine fabric laminate, absorbent foams, absorbent sponges, superabsorbent polymers, absorbent gelling materials, and combinations thereof.

The configuration and construction of the absorbent core 28 may also vary (e.g., the absorbent core or other absorbent structure may comprise zones of varying thickness, may have different hydrophilic gradients, superabsorbent gradients, or lower average density and lower average basis weight of receiving zones, or may include one or multiple layers or structures).

Examples of absorbent structures used in absorbent assemblies are described in U.S. Pat. No. 4,610,678 entitled " High-Density Absorbent Structure " issued to Weisman et al. on Sep. 9, 1986; No. 4,673,402 entitled " Absorbent Articles With Dual-Layered Cores " U.S. Patent 4,834,735 entitled " High Density Absorbent Members Having Lower Density and Lower Basis Weight Acquisition Zones " issued to Alemany et al. on May 30, 1989; No. 4,888,231 entitled " Absorbent Core Having A Dusting Layer " issued to Angstadt on December 19, 1989; No. 5,137,537 entitled Absorbent Structure Containing, Individualized, Polycarboxylic Acid Crosslinked Wood Pulp Cellulus Fibers "issued to Herron et al. on Aug. 11, 1992, U.S. Pat. No. 5,147,345 entitled " High Efficiency Absorbent Articles For Incontinence Management " No. 5,342,338 entitled "Disposable Absorbent Article For Low-Viscosity Fecal Material (Disposable Absorbent Product For Low Viscosity Faecal Materials)", issued to Roe on August 30, 1994, in U.S. Patent 5,260,345 entitled " Absorbent Foam Materials for Aqueous Body Fluids and Absorbent Articles Containing Such Materials (absorbent foam materials for aqueous body fluids and absorbent articles containing such materials), issued to DesMarais et al., On Nov. 9, 1993, in the US No. 5,387,207 entitled " Thin-Until-Wet Absorbent Foam Materials For Aqueous Body Fluids And Process For Making Same (Absorbent Foam Materials That Remain Thin Until Moisture For Retaining Watery Body Fluids And Manufacturing Process) " Dyer et al., Feb. 7, 1995, and further in the US No. 5,625,222

-9 · ··································· Under the title “Absorbent Foam Materials For Water Fluids Made From High Internal Phase Emulsion Having Vera High Water-To-Oil Ratios” (absorbent foam materials for aqueous liquids made from high internal phase emulsions and very high water-in-oil ratios) ', Issued in the name of DesMarais et al., July 22, 1997. Patents are assigned for comparison.

The diaper 20 may also include at least one resilient waistband 34 that helps to improve the adhesion of the diaper to the wearer's body and the retention of absorbed fluids. The elastic waist member 34 extends longitudinally outwardly from at least the 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 often designed to include two elastic waist members, one disposed in the first waist region 36. and one located in the second waist region 38. While the elastic waist feature 34, or any portion thereof, may include one or more separate elements attached to the diaper 20, the elastic waist feature 34 may also be constructed as an extension of other diaper elements 20, e.g. 26, the topsheet 24 and / or both of said layers 26, 24.

The elastic waist member 34 may be constructed in a variety of configurations, including those set forth in U. S. Patent 4,515,595 issued to Kievit et al. On May 7, 1985; No. 4,710,189 issued to Lash on Dec. 1, 1987, U.S. Pat. No. 5,151,092 issued to Buell on Sep. 9, 1992; No. 5,221,274 issued to Buell on June 22, 1993. Other suitable waist feature arrangements may include the waist cap described, for example, in U.S. Pat. No. 4,816,025 issued to Foreman on March 28, 1989; U.S. Patent 5,062,364 issued to Robertson on June 25, 1991.

The diaper 20 may also include a fastening system 40. The fastening system 40 includes a tape-to-tape (or Velcro) fastening system, other fastening systems are possible. Examples of fastening systems are disclosed in U.S. Pat. No. 3,848,594 entitled "Tapes Fastening System for Disposable Diaper", issued to Buell on Nov. 19, 1974, U.S. Pat. U.S. Patent 4,662,875 entitled "Disposable Diaper Having An Improved Fastening Divider" issued to Scripps on July 11, 1989, U.S. Pat. No. 4,894,060 entitled " Disposable Diaper With Improved Hook Fastener Portion " issued to Nestegard on Jan. 16, 1990, U.S. Pat. No. 4,946,527 entitled " Pressure Sensitive Adhesive Fastener & Method of Making Same (Adhesive Fastening Adhesive Sensitive "). • ······· · ··· 9 • · «· ···· · · · ······ · ·

- 10 (pressure and method of manufacture thereof) "issued in Battrell on August 7, 1990, U.S. Pat. No. 5,151,092 issued to Buell on Sep. 9, 1992; No. 5,221,274 issued to Buell on June 22, 1993. The fastening system may also provide means for holding the article in a usable configuration as disclosed in U.S. Pat. No. 4,963,140 issued to Robert Son et al. Oct. 1990. In an alternative embodiment, the opposing sides of the laundry may be stitched or welded to form panties. This allows the product to be used as a slip-on diaper, for example in a training pants.

The diaper 20 may also include side panels 30. The side panels 30 may be resilient or extensible to provide greater comfort and fit to the contours of the wearer ' s body, and remain in this state throughout the wearer even after the diaper has been filled with exudates. since the resilient side panels 30 allow the sides of the diaper 20 to expand and contract.

While the diaper 20 of the present invention has side panels disposed in the second waist region 38, the diaper 20 may include side panels 30 disposed in the first waist region 36 and the second waist region 38. The side panels 30 may be constructed in various suitable arrangements. Examples of diapers with sprung side panels are disclosed in U.S. Pat. No. 4,857,067 entitled "Disposable Diaper Having Shirred Ears" issued to Wood et al. on Aug. 15, 1989; No. 4,381,781 issued to Sciaraffa et al. on May 3, 1983; No. 4,938,753 issued to Van Gompel et al. on Jul. 3, 1990; No. 5,151,092 issued to Buell on Sep. 9, 1992; No. 5,221,274 issued to Buell on Jun. 22, 1993; U.S. Patent 5,669,897 issued to LaVon et al. on Sep. 23, 1997, entitled " Absorbent Articles Providing Sustained Dynamic Fit " No. 08 / 915,471 entitled " Absorbent Article With Multidirectional Extensible Side Panels " filed August 20, 1997 by Robles et al., said documents being cited for comparison.

The diaper 20 further includes thigh cuffs 32 that provide improved containment of fluids and other body secretions. The thigh cuffs may also be referred to as thigh bands, side flaps, barrier cuffs, or elastic cuffs. U.S. Pat. U.S. Patent 3,860,003 discloses a disposable diaper with a collapsible throat opening with a side flap (wing) and one or more resilient members that form a spring-loaded thigh cuff (sealing cuff). U.S. Pat. and U.S. Pat. Nos. 4,808,178 and 4,909,803 issued to Aziz et al.

Quiet February 28, 1989 and March 20, 1990, discloses disposable diapers with " erect " spring flaps (barrier cuffs) that improve fit in the thigh regions. U.S. Pat. U.S. Patents 4,695,278 and 4,795,454 issued to Lawson on September 22, 1987 and Dragoo on January 3, 1989, disclose disposable diapers with double cuffs including sealing cuffs and barrier cuffs. In some embodiments, it may be desirable to treat all or some of the thigh cuffs with a lotion as described above.

Embodiments of the invention may also include pockets for receiving and retaining waste, a spacer providing free space for waste, barriers to restrict movement of waste within the product, cell or free space for receiving and retaining waste material placed in the diaper and the like, and combinations thereof. Examples of pockets and spacers for absorbent articles are described in U.S. Pat. No. 5,514,121 issued to Roe et al. on May 7, 1996 under the title "Diaper Having Expulsive Spacer"; No. 5,171,236 issued to Dreier et al. on Dec. 15, 1992, entitled " Disposable Absorbent Article Having Core Spacers, " No. 5,397,318 issued to Dreier on March 14, 1995 entitled " Absorbent Article Having A Pocket Cuff " No. 5,540671, issued to Dreier on July 30, 1996, entitled " Absorbent Article Having A Pocket Cuff With An Apex ", in PCT Patent Application WO 93/25172 published December 3, 1993 under entitled "Spacers For Use In Hygienic Absorbent Articles And Disposable Absorbent Articles Having Such Spacers", in the US No. 5,306,266 entitled "Flexible Spacers For Use In Disposable Absorbent Articles", issued to Freeland on April 26, 1994. Examples of cells or voids are disclosed in U.S. Pat. U.S. Patent 4,968,3112 entitled Disposable Fecal Compartmenting Diaper "issued to Khan on Nov. 6, 1990, U.S. Pat. U.S. Patent 4,990,147 entitled " Absorbent Article With Elastic Liner For Waste Material Isolation (Absorbent Article With A Flexible Insert For Waste Material Insulation) " issued to Freeland on Feb. 5, 1991, U.S. Pat. No. 5,269,755 entitled "Trisection Topsheets For Disposable Absorbent Articles And Disposable Absorbent Articles Having Such Trisection Topsheets (Top Sections With Disposable Absorbent Articles And Disposable Absorbent Articles

4

No. 4 "use comprising such three-section topsheets" "issued to Freeland et al. On Dec. 14, 1993. Examples of suitable transverse barriers are disclosed in U.S. Pat. No. 5,554,142 entitled " Absorbent Article Having Multiple Effective Height Transverse Partition " issued to Dreier et al. on September 10, 1996 in PCT patent application WO 94/4395 entitled " Absorbent Article Having An Upstanding Transverse Partition ”issued in the name of Freeland et al., July 7, 1994, in the US No. 5,653,703 entitled " Absorbent Article Having Angular Upstanding Transverse Partition " issued to Roe et al. on Aug. 5, 1997. All of said documents are cited for comparison.

Embodiments of the present invention may also include the waste handling device 110 shown in Figure 7. The waste handling device 110 may include a waste bag 111 in which faeces, urine, or both waste is collected. The waste bag 110 may include an opening 12 and a skirt 112 surrounding the opening and serving to adhere to the perianal region of the wearer. The waste handling device 110 has proven to be a very useful device when used in conjunction with laundry, a diaper preferably with a disposable diaper. An example of an absorbent article, such as a diaper 120 comprising a waste bag 111 is shown in Figure 8. In conjunction with a diaper 120 or other garment, the waste bag 111 may be placed on (or attached to) any surface of the article. In one embodiment, the waste bag 111 is attached to the topsheet 124 of the diaper 120.

The waste bag 111 is a flexible receptacle for receiving expelled faeces or urine. The garbage bag is therefore liquid impermeable, but may be breathable. The waste bag 111 is strong enough to withstand adverse wear conditions, such as sitting.

The waste bag 111 comprises one or more layers. In one embodiment, the waste bag 111 comprises three layers, preferably one film and two nonwoven layers. The layers of the bag material can be made of any material, preferably the bag is liquid impervious. In a preferred embodiment of the present invention, the laminate may be formed from a nonwoven layer and a film.

Suitable film materials, for any film layer, include a thermoplastic material. The thermoplastic material may be vapor-permeable (but also impermeable) and may be selected from all types of hot-melt adhesive, i.e., polyolefins, especially polyethylene, polypropylene, amorphous polyolefins, and the like, from material ·· · ♦ · · R r r r e e e e e e e e e e * * * * * * * * * * *

13 comprising fusible components comprising fibers or poles a specific binder, including natural fibers, for example pulp, cotton, jute, hemp, and synthetic fibers, for example, glass fibers, rayon, polyester fibers, polyolefin, acrylic, polyamide, aramide fibers , polytetrafluoroethylene metal, polyamide, binders such as high / low melting point two-component polymers, polyester copolymers, polyvinyl chloride, polyvinyl acetate / chloride copolymer, polyamide copolymer, materials including mixtures in which some of the base materials are non-fusible, air and vapor-permeable materials including microporous films previously described in connection with the backsheet, and monolithic breathable materials such as Hytrel ™ from DuPont and Pebax ™ from ELF Atochem, France.

The waste bag 111 may have a different shape and size. Preferred shapes include a flat circular bag type, a conical bag, a shortened conical shape and a pyramidal or truncated pyramid bag and a T-shaped flat bag. The waste bag 111 can be manufactured from a single piece of material or from a plurality of individual pieces of material. (which may be of the same or a different material) by circumferential welding.

The waste bag 111 may also comprise an absorbent material. The absorbent material may be any absorbent material capable of absorbing and retaining fluids. 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 in relation to the absorbent core.

The waste bag 111 has an opening 121 through which faeces or urine is received before it is stored inside the cavity of the bag. The opening 121 is preferably surrounded by a skirt 112 and may be of any shape and size, for example, it may be circular, elongated, heart-shaped, symmetrical or asymmetric, with an elongated shape in the longitudinal or transverse direction being preferred. The skirt may have protrusions adapted to the perianal, genital and / or coccygeal surface of the user's body.

The skirt 112 can be made of a soft, resilient, flexible material that allows the skirt 112 to be easily positioned in the perianal or urogenital region. Typical materials include nonwoven materials, open cell thermoplastic foams, closed cell thermoplastic foams, open cell foam composites and stretched nonwoven fabrics, and films.

The waste bag 111 further comprises clamping means for securing the device to the user's body. Such means may include belts or compatible pressure-sensitive adhesives disposed on a portion of the garbage bag facing the user. Skin ////

The non-irritating pressure-sensitive adhesive and waterproof material can also be used to attach the device in the perianal and urogenital area of the user, such as a hydrocolloid and a hydrogel adhesive. Particularly effective adhesives which provide the desired properties when attaching the skirt to the wearer ' s skin in the sensitive perianal region while allowing painless application and diaper removal are made of crosslinked polymers with a plasticizer to form a three-dimensional matrix.

The article 20 also includes at least one sensor 60 adapted to detect one or more health / nutrition indicators in body waste, and which even has sufficient capacity to provide a signal to the user or caregiver of the presence of said indicator. As used herein, the term "sensor" refers to a device that is capable of detecting an event or parameter that is associated with events. The event-associated parameter can be any measurable signal that is consistent with an event within the system (i.e., a signal generated by waste, user, or waste components). The sensor includes anything that responds to one or more specific inputs. The sensors may be chemical, electrochemical, biochemical or biological, mechanical magnetic, thermal and other signals known in the art. Products of the invention include sensors that provide a signal to the user, caregiver or actuator that indicates the presence and / or concentration of one or more health or nutritional status indicators in body waste, for example, faeces, urine, or menstrual substances. The signal may be an optical signal including a visual signal (e.g., a calorimetric or fluorescent indicator) a chemical signal (responsive to a change in pH, enzyme activity, or a concentration of any chemical species), or an electrical signal.

"Health indicators" and "nutrition indicators" (eg in human faeces) refer to any basic, chemical or biological constituents that may be found in waste, as well as combinations and relationships between (eg ratios, etc.) constituents having a defined relationship with the user's health (illness, infection, poisoning, etc.) and the nutritional status of the user. The nutritional status of the user includes, for example, metabolic activity, nutrient deficiency, nutrient absorption or absorption, food and fluid intake, food allergy (eg nuts), intolerance to lactose, bacterial ecology in the colon (beneficial bacteria - bifidobacteria) and lactobacillus)) and overall energy balance. Health indicators may include heavy metals (lead, mercury, etc.) radioactive substances (cesium, strontium, uranium, etc.), fats, enzymes, endogenous secretions, protein substances, mucus and microorganisms (described in the biosensor section), which may be related to a variety of medical conditions, such as infection, diarrhea, digestive problems, or • · · · · · · · · · · · · ···················· · 15 -Food. Heavy metals, especially in underdeveloped countries and in older and / or richer areas of developed countries, create health risks. For example, lead and mercury poisoning can occur after ingestion of these heavy metals from natural sources (lead paints, unregulated heavy industry, etc.) and can have fatal consequences. Lighter poisoning with these heavy metals is more common, but may result in delayed intellectual and / or physical development, especially in children, may occur over a longer period of time and may have a lasting effect on personality. Protein substances, such as proteins (in the urine), can be detected by targeting the detection to Tamm-Horsfall proteins. A suitable example of a Tamm-Horsfalla protein sensor is described in U.S. Pat. No. 5,780,239, incorporated herein by reference. Suitable heavy metal sensors and / or discriminant means used by the sensor are described in detail in U.S. Pat. Nos. 5,595,635, 5,865,972, 5,814,205, and 5,468,366, which are also incorporated herein by reference.

Non-limiting examples of the nutrient indicator include calcium, vitamins (e.g., thiamine, riboflavin, niacin, biotin, folic acid, pantothenic acid, ascorbic acid, vitamin E, etc.) electrolytes (e.g., sodium, potassium, chlorine, bicarbonate, etc.), fatty acid fats. (long and short chain) soaps (e.g. calcium palmitate), amino acids, enzymes (e.g. lactose, amylase, lipase, trypsin etc.) bile acids and their salts, steroids and carbohydrates. For example, insufficient calcium absorption is severe in that it causes long-term decalcification of the bones. While the magnitude of calcium absorption in adults, especially older women, is sufficiently publicized, this should also be taken into account in children, especially infants. Baby food has an effect on calcium absorption and thus on bone mass and its density. For example, it has been shown that changing the position of palmitic acid on triglycerides in infant formulas, from the second position (ie breast milk) to the first and / or third position (ie, as with some baby food), results in less cleavage of palmitic acid from the “spine” of triglyceride and thus reduced absorption of this nutrition by the body. Uncleaved palmitic acid binds calcium in the gastrointestinal tract as a soap (calcium palmitate) and leaves the body in the feces (described in more detail in the Archive of Disease in Childhood (November 1997, 77 F178-F184)). Suitable calorimetric calcium sensors based on Arsenazo ΙΠ (acidic environment) and Cresolphtahalein Complexone (alkaline environment) are available from Sigma-Aldrich Chemical of St. Lois, Mo, catalog number 588- 3 and 587-A. Other examples of calcium sensors and / or discriminant means suitable for sensors are described in greater detail in US Patent 5,705,620, US Patent 5,80,441 and US 5,496,522.

···············································

The sensors of the present invention may be coupled to a transmission structure. The transmission structure may hold, stabilize and / or partially encapsulate the sensor. Examples of the transfer structure include one or more layers of woven or nonwoven fabric, film, foam, scrim, hydrogel, and the like. The sensor may be attached to the transfer structure, may be held between two or more components, or folds of the transfer structure, or it may be sealed within the transfer structure. The transfer structure may optically include an adhesive or body-adjacent composition, or other attachment means adapted to at least a portion of the transfer structure be bonded to the article or component thereof, or to the wearer's skin. In addition, at least a portion of the carrier structure may be water-soluble.

In certain embodiments of the present invention, the sensor 60 may include a biosensor. As used herein, the term "biosensor" is defined as a component comprising one or more biologically reactive means adapted to detect one or more target pathogenic microorganisms or related biomolecules (enzyme, organelle, tissue, microorganism, sensor, and electrochemical sensor). The term "biologically reactive" is defined by the ability to selectively interact (preferably bind) with target pathogenic microorganisms and / or related biomolecules as described above. Generally, biosensors function to provide means for specific binding, and thus detection of target biologically active analytes. In this way, biosensors are highly selective, although they manifest themselves in a mixture of many chemical and biological entities, such as faeces. Chemical sensors that rely on chemically reactive agents generally do not have as high selectivity or enhancement properties as biosensors and are therefore not suitable for the detection of biologically reactive analytes, especially when present in low concentrations and / or in complex media, such as body waste. Often, the target biological analyte is a minor component of the composition, which includes a number of biological and other components. In many biosensor detection applications, even smaller values than particles / billion, particles / trillion are required for target analytes. Accordingly, biosensors are required to recognize target biological analytes in a complex mixture at a discriminatory ratio of about 10 ⁷ - 10 ⁸ or greater.

The biosensor of the invention may include a bio-recognition element or a molecular recognition element that provides highly specific binding or detection selectivity for a particular analyte. The bio-recognition element or system may be a biological material, for example, an enzyme or enzyme sequence, an antibody, a membrane receptor protein?, DNA, an organelle, a natural or artificial cell membrane, an intact, viable or non-viable bacterial, a plant. · · ·>>>>>>>>>>>>>>>>>>>>>>>>>>>

- 17 or an animal cell or piece of plant or mammalian tissue and, in general, functions capable of specific interaction with the target biological analyte. The bio-recognition element is responsible for the selective recognition of the analyte and the physical-chemical signals underlying the output signal.

The biosensors may include biocatalytic biosensors and bioaffinity biosensors. In biocatalytic biosensors, the bio-recognition element is "biocatalytic" and may include enzymes, organelles, pieces of plant or mammalian tissue, or whole cells, while selective binding sides "turn" (can be used again during the detection process), resulting in Significant amplification of the input signal. Biocatalytic sensors are useful in real-time and continuous sensing.

Bioaffinity sensors are generally used in bacteria, viruses and toxins, including bio-sensors based on chemoreceptors, and / or immuno-sensors (immuno-sensors). Chemoreceptors are complex biomolecular macro assemblies responsible, at least in part, for the ability of viable organisms to capture chemicals in their environment with high selectivity. Chemoreceptor-based biosensors include one or more natural or synthetic chemoreceptors associated with the means to provide a signal (visual, electrical, etc.) responsive to the presence or concentration of the target electrical signal of the biological analyte. In certain embodiments, the chemoreceptor may be coupled to an electrode (electrical converter) to provide a detectable electrical signal. Chemoreceptors may include all or part of nerve bundles (from antennae or other sensing organs) and / or all or part of natural or synthetic cell membranes. Bio-recognition elements of immuno-sensors are generally antibodies. Antibodies are highly characteristic and can be produced against bacteria, viruses, parts of microorganisms (bacterial cell walls, parasite eggs, or parts thereof) and large biomolecules. Suitable antibodies may be monoclonal or polyclonal agents. In any case, bio-readers with bioaffinity are irreversible, as the sides of the bio-reader receptor become saturated when exposed to the target biological analyte.

In a certain embodiment, biocatalytic and affinity biosensors can be combined, such as RNA / DNA probes or other binding systems in which an initial recognition event is followed by a biological amplification of the signal. For example, certain bacteria can be detected using biosensors containing genetic material, for example, DNA as a bio-recognition element and PCR (polymerase chain reaction) amplification to detect small amounts of organisms, i.e., less than or equal to 500 organisms. Affinity biocatalytic and biosensor systems are described in more detail.

18 described in Joumal of Chromatography, 510 (1990) 347-354 and in the Kirk-Othmer Encyclopedia of Chemical Technology, fourth edition (1992), John Wiley & Sons, NY. Documents are given for comparison.

The biosensors of the present invention detect biologically active analytes that are associated with an upcoming (future presence of symptoms, etc.) or current systemic disease state, including but not limited to pathogenic bacteria, parasites (at any stage of the life cycle, including eggs) and parts thereof, cysts, or mature organisms), viruses, fungi, for example Candida albicans, pathogen antibodies and / or microbially produced toxins. In addition, biosensors can label biologically active analytes associated with upcoming or current localized health problems, such as stress proteins (cytokines) and IL-Ια (interleukin 1-alpha), which can prevent clinical skin irritation or skin inflammation. In a preferred embodiment, the biosensors function as a more active sensor detecting and signaling the situation to the user or caregiver before the clinical symptoms occur. This brings time for the administration of prophylactic and therapeutic agents that can significantly reduce, if not prevent, the aggravation and duration of the symptoms. The sensor 60 detecting the presence of the target biological analyte in the user's body waste may further detect residual contamination of the surface, for example, the skin that is in contact with the biosensor, and may provide an appropriate signal.

The physico-chemical signal generated by the bio-recognition element or elements can be transmitted visually to the user (for example, by changing the color visible to the naked eye). Other embodiments may provide an optical signal but require additional devices to amplify it. The optical signal includes fluorescence, bioluminescence, total reflection resonance, surface plasmon resonance, Raman methods and other laser-based methods. Examples of surface plasmon resonance biosensors are available as IBIS and IBIS II from the XanTec Analysis System of Muenster, Germany, and may include, as bio-cognition elements, biologically associated surfaces. Alternatively, the signal may be sent via a connected transducer which may, for example, produce an electrical signal (current, potential, inductance or impedance) that may be displayed (for example, on an LED reader or LCD display) or trigger an audible or tactile a signal, or a signal that triggers the active member as described above. The signal may be a qualitative signal (detecting the presence of the target biological analyte) or a quantitative signal (measuring the amount of concentration of the target biological analyte). In such an embodiment, the transducer may optionally produce an optical, thermal, or acoustic signal.

»· · · · • • • • -19 In any case, the signal may be a durable signal (stable and readable for the duration of use of the product), or a transient signal (registered by real-time measurement). In addition, the signal may be transmitted to a remote location of the indication (by wire, radio, for example, infrared or rf radio) including other locations within the products or to remote devices. The sensor 60, or components thereof, may be adapted to sense and / or merely signal the concentration of the target biological analyte above a predetermined threshold (e.g., where the target biological analyte is present in body waste, or when the analyte concentration is below a "hazardous" "Value).

As noted above, the target analytes for which the biosensors of the invention are adapted for detection may be pathogenic microorganisms, for example pathogenic microorganisms in the human gastrointestinal tract, and which may cause diarrhea. This type of pathogen is particularly important for monitoring, due to the large number of children who become seriously ill or die of such diarrhea. It has been found that severe chronic diarrhea can lead to weight loss and permanent physical and mental retardation. The non-limiting list of pathogenic bacteria that sensor 60 can detect includes any of a variety of pathogenic strains of Escherichia coli (commonly known as E. coli), Salmonella strains including S.typhus, paratyphoid, S.enteriditis, S.Typhymurium, and S.heidelberg strains. Shigella, Shigella sonnei, Shigella flaxneri, Shigella boydii and Shigella dysenteriae, Vibro cholerae, Mycobacterium tuberculosis, Yersinia enterocolitica, Aeromanas hydrophila, Plesiomonas shigelloides, Campolybacter strains such as C. jejuni and C. coli, Bacteroides fragisum C.prfringens, C. butulinum and C. difficile. A non-limiting example of commercially available E.coli biosensors adapted to detect E. coli is available from AndCare, Inc. of Durham, NC as Test Kit # 4001. Another non-limiting example relates to et al. ABTECH, Scientific, Inc, of Yardley, PA, which offers a "bioanalytic bioconversion" labeled BB Au-1050.5-X that can be considered biospecific (for organisms or other target biological analytes already described) by covalently immobilizing polypeptides, enzymes, antibodies, or DNA fragments on their surfaces. Other suitable microbial biosensors are described in U.S. Patent Nos. 5,862,272 (gram negative organism), 5,795,711 (Shigella), 5,830,341, 5,795,453, 5,354,661, 5,783,399, 5,840,488, 5,827,651, 5,723,330, 5,496,700, all patents given for comparison.

The target analytes that the biosensors of the present invention can detect can also be viruses. The viruses may include diarrheal diseases, such as rotaviruses or other viruses, such as rhinovirus and HIV. An example of a biosensor adapted to • · · · · · · · · · · · · ·

The detection of HIV virus is described in U.S. Pat. Nos. 5,830,341 and 5,795,453. Both patents are given for comparison

In an alternative embodiment, the target analyte detectable by the biosensor according to the invention may be, for example, parasites, particularly those found in the digestive tract at a certain stage of its life cycle. Such parasites may be protozoa, worms, and other intestinal parasites. Other examples of detectable parasites include entamoeba hystolytica (causing amoebic dysentery), trypana cruzi (causing Chagas' disease), and plasmodium falciparum.

In another embodiment, the target analytes that the bioassays of the invention are able to detect are, for example, fungi such as Candida albicans. In addition to pathogenic bacteria, colon bacteria can be detected and / or measured as an indicator of health, for example, Bifidobacteria and Lactobacilus strains.

The target analytes that the biosensors of the invention are able to detect may also be proteins or antigens associated with skin problems. These analytes are detected on the skin surface prior to clinical detection of visible skin irritations. They may include stress proteins such as cytokines, hystamine and other immune factors including interleukins (such as IL-Ια, IL-2, IL-3, IL-4 and IL-8) and interferons (including interferons α and g). Said analytes are detectable by sensor 60 prior to the onset of clinical detection of flushing, irritation or dermatide. In addition, the biosensors of the invention can be adapted to detect enzymes or other biological factors leading to skin irritation (diaper dermatitis), including trypsin, chymotripsin and lipase.

The biosensor of the invention may include bio-recognition systems including enzymes or binding proteins, for example, antibodies immobilized on the surface of physicochemical transducers. For example, a specific strain of bacteria can be detected using biosensors that act against antibodies to bacteria strains. Alternatively, the target bacterium can be detected using a bio-recognition element (including antibodies and synthetic and / or natural molecular receptors) specific for the extracellular products of the target bacterium, for example, toxins produced by strains (e.g. E. coli). Enzyme electrodes that can be used to detect phenols (in urine or faeces) include tyrosinase-based electrodes or polyphenol oxidase-based electrodes are disclosed in U.S. Pat. No. 5,676,820 entitled "Remote Electrochemical Sensor" issued to Joseph Wang et al. on October 14, 1997; No. 5,091,299, entitled " An Enzyme Electrode For Use In Organic Solvents. " • ··· ♦ ··· · · · · · · · · · · ·

-21 use in organic solvents ") issued in the name of P. F. Turner et al. On February 25, 1992. Both patents are cited for comparison.

In one of the foregoing examples, a particular microorganism may be detected directly, or may be detected by binding of a toxin, enzyme, or other protein produced by an organism or antibody, for example, an organism-specific monoclonal antibody. Exemplary biosensors adapted to detect proteolytic enzymes are disclosed in U.S. Pat. No. 5,607,567 and the toxins of U.S. Pat. Nos. 5,496,452, 5,521,101 and 5,567,301.

Any of the sensors 60 of the present invention may include one or more "more active sensors". This is particularly advantageous in embodiments in which the detection of target biologically reactive analytes, health and / or nutritional indicators precedes the onset of clinically observable health symptoms. As used herein, the term "more active sensor" refers to a sensor that is capable of detecting changes or signals on the user's body (on the skin) or in waste, i.e. inputs that are directly related or at least correlate to the occurrence of an upcoming or potential health event. More active sensors can sense one or more inputs as described above.

The more active sensor 60 may detect an upcoming event, or may detect a parameter that is directly related, or at least correlate with the occurrence of an upcoming event, namely a systemic or skin event or condition (presentation of clinically observable signs or symptoms). The upcoming event to be detected or predicted by the more active sensor 60 of the present invention may include the initial stages of lead poisoning, the initial stages of nutritional deficiency and / or vitamin deficiency caused by poor digestion, diarrhea, skin irritation or rash (including candidiasis) , or other types of diseases or medical conditions, such as parasite infestation. The established health condition, the nutritional indicator, and / or the biological analyzer may be one or more steps away from the actual presentation of the clinical symptoms. For example, the sensor may detect potential precursors to the aforementioned health conditions (contamination of the skin with faeces, which may be preceded by induction of stress proteins, which may prevent clinically observable irritation). The parameter correlating with the event is any measurable input, signal, for example one of the possible inputs mentioned above, which correlate with the occurrence of events within the system (waste or user induced signal). multiple outputs. For example, a more active transducer 60 may monitor Candida Albicans in the faeces, and -22 Residual colon bacteria on the skin (residual infestation), both findings may prevent skin irritation.

In an embodiment of a biosensor in which the bio-recognition element produces no readily visible signal (for example, a color change), the sensor 60 may include a transducer in contact with the bio-recognition element to convert physiochemical signals from the bio-recognition element into usable signals for the user; or the components of the product (per actuator). Exemplary transducers may include electrochemical transducers (including potentiometer, ammeter, and conductivity transducers), optical transducers (including fluorescent, bioluminescent, and total internal reflection resonance, and plasmin resonance based transducers), thermal transducers and acoustic transducers known in the field. A power source such as a 3 V battery or a lithium battery on the printed film can be connected to the sensor 60.

The efficiency of the biosensors according to the present invention can be measured by the response factor test, which will be described in the Test Method chapter. The response factor describes the ratio of the bio-sensor response to faecal material to the bio-sensor response to saline, the ratio being a useful value for determining the sensitivity of a bio-sensor to biologically active analytes expected to occur in faeces rather than in urine. The biosensors of the invention have a response factor of at least 2, 3, or 5, preferably at least 10, even more preferably at least 20 when exposed to test fecal material in aqueous solution or test urine, with a solution concentration of 1g fecal material per 1g saline. (Here, physiological saline is a background input signal that is present as a natural part of the environment, for example, aqueous body fluid). Such biosensors are able to clearly distinguish between the presence of faecal material and the presence of physiological saline, taking into account the faecal-specific target biologically active analyte.

One method of detecting the presence of faeces is to detect skatol (a malodorous portion of faeces) present as part of the faecal material. The fecal skatol concentration was found to be about 180 pg / g of fecal material, while the urinary skatol value was significantly lower. Skatol is a product of microbiological degradation that originates from the catabolism of tryptophan in the digestive system.

In one preferred embodiment, the biosensor detecting skatol comprises a biosensor comprising a genetically engineered microorganism that assimilates skatol and / or other components. The assimilation of the skatol components can be measured, for example, by oxygen consumption during the assimilation process. A microorganism capable of detecting skatol includes Acinetobacter

-23baumannii TOI36 (FERM P-12891, Japanese patent application JP05304947), and Bacilus sp T0141 (FREM P-12914, Japanese patent application JP05304948). Suitable biosensors comprising these microorganisms are available, for example, from the Institut fuer Chemo- und Biosensorik, Muenster, Germany, under the designation Mikrobielle Sensoren.

When microorganisms are included in the biosensors, they can be immobilized in the biosensor by a technique known in the art, for example, by capture, adsorption, cross-linking, encapsulation, covalent bonding, and combinations thereof. The immobilization can be carried out on various substrates known in the art. In certain embodiments, the immobilizing substrate may be selected from the group of materials based on polymers, hydrogels, tissues, nonwoven materials and woven materials.

In some embodiments, the sensor 60, with any embodiment of the biosensor, may include or be located on, or operatively connected to, a microchip, for example, a silicon chip, a MEM (micro electromechanical system) device, or an integrated circuit. The microchip-based biosensor may comprise a plurality of sensor components with different or equal sensitivity, kinetics, and / or may include target analytes (indicators) in any array adapted to detect different levels, or may include combinations of said analytes. Each sensor in such an array may provide a different kind of signal, including those listed herein, and further may be connected to different actuators and / or actuators. Each sensor in the array can operate alone or in conjunction with (in parallel or in series) with any number of other sensors in the array.

Any sensor 60 according to the present invention may be located in, and / or operatively connected to, any portion of the disposable product that will be exposed to the input that the sensor is to detect. For the purposes of the present invention, the term "operatively connected" refers to a connection means in which the sensor 60 can signal any part of the article 20 when the sensor has detected an input. The sensor 60 may be separate (and operatively connected) from another portion of the sensor 60, another sensor 60, actuator, control, or other portion of the article 20. For example, an "operative connection" may include a means of connection, for example signal (radio frequency transmission), infrared frequency transmission, etc.). Alternatively, the sensor 60 may be operatively connected by a mechanical connection, for example a pneumatic or hydraulic connection.

In one embodiment of the article (diaper 20 in Fig. 1), the sensor 60 may be located in the front waist area 36, the back waist area 38 or the crotch area 37 of the article. ······················ · · 9 · 9 9 9

-2420 and may be integral, proximate, attached to, or include a portion of the body 22, topsheet 24, backsheet 26, absorbent core 28, side panels 30, thigh cuff 32, waist panel 34, and fastening system 40, longitudinal 50 or end 52 edges, etc. In some preferred embodiments where the target biological analyte is associated with body waste, the sensor 60 may be positioned in the crotch region of the article 20 to minimize the likelihood of body waste contacting the sensor 60.

In another preferred embodiment, in which the sensor is adapted to detect or measure a target biological agent on the user's skin, the sensor 60 may be located on the topsheet, waistband, cuff, feces receiving pocket, spacer, and other portion of the article. that may come into contact with the user's skin during use. In certain embodiments, the sensor may also be associated with a lotion or other skin care product.

The sensor 60 may be integral with the article 20, or may be installed by a user or caregiver. The sensor may detach from the product during use and may adhere to the user's skin. The sensor may be rigidly or removably (using a Velcro ™ mechanical fastening system, or water-soluble adhesive) to a support structure including adhesive tape, cellulosic or synthetic fabric, film, scrims, foams, and the like. enclosed within the article 20, or may have a receiving portion disposed within the product so as to come into contact with an inlet and another portion (a transfer portion) disposed either inside or outside the product. The sensor may be located outside the article 20, and may be coupled to some part of the article 20 such that it can sense an input located outside the article 20 while providing a signal to the controller and / or the active element. In some embodiments, the sensor may be detached from the article, i.e., separately positioned on some part of the user's body by means of an adhesive, and / or may comprise multiple components separated from the article.

In some embodiments, there may be a cleaning device or element that allows the carer or user to remove body waste from the sensor 60 and thereby allow a visual determination, or reading, of the signal (especially in embodiments that provide such a signal). The cleaning element may include a fabric (cellulosic or synthetic, non-woven cloth, film, foam, rigid or semi-solid squeegee disposed in the article and adapted to clean the sensor display. The cleaning element may be at least partially attached to the article component, e.g. near the sensor 30 by known means.

• · · · · · • · φ · φ · φ · φ · φ · φ · φ ·

-25V

The cleaning compositions may optionally include water or other known cleaning compositions which may facilitate cleaning of the user or sensor display.

In certain preferred embodiments, the article 20 may also include an actuator. As used herein, the term "actuator" refers to devices that include a "potential" and a means to convert that potential to perform or activate a "response function". The potential of an actuator may include either stored or potential energy or stored material. Thus, the actuator can perform or activate the response function by converting potential energy into kinetic energy, or by releasing or supplying the stored material. For the purposes of the present invention, a "response function" is defined as a function realized in a bodily waste, a user, a product or a product component, or a signal to a user or a "caregiver. For example, the bodily waste component may include moisture, electrolytes, enzymes, volatile gases, bacteria, blood, and the like. The user ingredient may also include skin, genitals, anus, sphincter, muscle, etc. The article ingredient may also include thigh cuffs, waist cuffs, or other. waste barriers and / or retention components, side panels, handles, body, absorbent core, uptake component, fastening system, longitudinal and end edges etc. The potential energy may be stored as mechanical, electrical, chemical or thermal energy. "Kinetic energy" in this application refers to the capacity to perform the work or to perform the response function as already mentioned (expansion of compressed device, rotation of device, gel moving during phase change, coating or treatment of skin or faeces, preventing access enzymes, pH adjustment, etc.).

For example, initiating the process of creating a three-dimensional waste collection structure includes response functions performed with the product component, and finally with the waste. Waste capture Skin cleansing and skin treatment with skin care products, antimicrobial, fungicide or enzyme inhibitor are response functions performed with the waste and / or the user. Adjusting the dimensions of a product (to a one-dimensional, * two-dimensional, three-dimensional product) or its physical properties (bending module, geometry, etc.) are examples of the response functions to be implemented on the product. Signaling v

caregivers and / or users that an event has occurred or is about to occur is also considered, for the purposes of the present invention, as a function of the response. The signal may be visual, auditory, tactile, electrical, chemical and / or biological. For example, a disposable actuator may release or deliver a deodorant, an enzyme inhibitor, an antimicrobial, a fungicide, a skin care composition, a pH regulator, capture, clean, cover, immobilize, seal, pump or store body waste, initiate release or creating a structure or element designed to perform one or more of the following: ··· · · ♦ · · · · · · ·· ··

-26more of the aforementioned functions, or any other response function for waste, user, product and its constituents.

The actuator of the present invention may release potential energy to perform or activate a response function to a waste, user, product or component thereof. The release of potential energy can convert mechanical, electrical, chemical or thermal energy into mechanical, electrical or chemical kinetic energy, for the purpose of performing the response function. The actuator may be started by an input threshold to release potential energy (to perform a response function), or it may respond continuously to the input as described. For example, the compressed foam binds the compressive mechanical potential energy and, when released, can provide mechanical kinetic energy. The twisted foam binds torsional mechanical potential energy, which, upon release, can provide mechanical kinetic energy, such as rotational energy. In addition, bound mechanical, electrical or thermal energy may be used to release electrical, mechanical, chemical or thermal kinetic energy. For example, the disposable article of the disposable article may include one or more of the following: bound lotion, antifungal or antimicrobial, feces modifiers, enzyme inhibitors, pH buffer, dye, compressed gas, compressed foam, twisted foam, pump, closed fluid transport system , an electrically sensitive gel, a pH sensitive gel, a salt concentrating gel, etc. The potential energy can be stored in any manner that retains and controls the energy until requested. Suitable means for retaining and controlling such energy include, accumulators and / or capacitors, resilient, torsional and pressure-stressed materials, or structures in the form of non-reactive reagents, and materials capable of performing chemical functions (absorbents, plasticizers, pH buffering agents, enzyme inhibitors, excrement modifiers, compressed gases, etc.).

Alternatively, the actuator may include an amount of deposited material having the capacity to perform or activate a response function for the waste, user, product, or any component (s) thereof. For example, in one embodiment, the actuator may release or deliver a stored material that performs a response function. In this embodiment, the actuator may be lowered by the input threshold, which may cause the material to be released or dispensed continuously at a given time, but may also release or dispose of the material in a continuous manner. For example, the actuator may include stored lotion, skin care composition, antifungal and antimicrobial agents, excrement modifiers, enzyme inhibitors, pH buffers, dyes, etc. In certain embodiments where ··· ··· ··· ·· · ♦ ·

Preferably, the material may be dispensed by the actuator as a resilient material, such as released high pressure gas, etc.

Giant. 2 and 2A illustrate an actuator 90 that includes a compressed resilient material 94, such as foam, sealed by at least a partial vacuum within a pressure resolution device 91. The pressure resolution device as used herein is any device or structure that can retain the resilient material in a compressed state (it can store energy by providing limited pressure on the compressed elastic material 94). A 'compressed state' is defined as a state in which the material is maintained in a state of lesser volume than it would have been if it had not been constrained and had been subjected to zero pressure. With respect to the resilient material, the compressed state can be achieved by applying pressure to the surface of the material or by any other method known in the art. For example, the pressure resolution device may include a vacuum sealed bag or stretched materials, for example, elastic but also non-elastic bands, strands, strips, films, nonwovens, scrims or foams that compress the resilient material. The compression of the resilient material maintained by the speech discrimination device 91 may be at least partially limited (the resilient resilient material may at least partially expand) by means of a trigger mechanism. The trigger mechanism is any element or device, such as a sensor, actuator, or a combination thereof, that responds to the inlet to effect pressure equalization in the pressure resolution device 91, and further allows the compressed material 94 to at least partially expand. Upon release of the compressed resilient material 94, for example, upon detection of a target biologically active analyte, the compressed resilient material may expand and deliver the deposited material. In some embodiments, it may be preferred that the actuator include an empty space 96.

The resilient material may include any resilient material including, but not limited to, EVA foam, such as available from Foamex Corporation of Eddystone, Pennsylvania under the designation SIF / 210PP1 or Aquazone 80A foam, or from Santinel Products Corporation of Hyannis, MA under the designation MC1900 EVA 2 lb / ft ³ , or HIPE foams described in U.S. Patent 5,260,345 entitled "Absorbent Foam Materials For Aqueous Body Fluids And Absorbent Articles Containing Such Materials", issued to DesMarais et al., Nov. 9, 1993, U.S. Pat. No. 5,387,207 entitled " Thin-UntilWet Absorbent Foam Materials For Aqueous Body Fluids & Process For Making Same (Moisture Absorbent Foam Materials for aqueous body fluids) and their production process), issued to Dyer et al. on Feb. 7, 1995, in U.S. Pat under 5,625,222 under the title “Absorbent Foam Materials For Aqueous Fluids Made From High” 9 · 9 9 «9 · 9 · 9 · 9 · 9 ··· ·· · ···· «« φ *

-28Intemal Phase Emulsions Having Vera High Water-To-Oil Ratios (Issued in the name of DesMarais et al., July 22, 1997 All patents are listed for comparison.

In some embodiments, according to the present invention, the pressure resolution device 91 may comprise a soluble bag. The soluble bag may be a soluble bag in the presence of one or more kinds of inlet, for example water, urine, fecal enzymes, a certain pH value, etc., and may have physical or chemical properties (thickness) allowing a design that allows to set a threshold of such desired inlet to dissolve the bag. For example, the soluble bag may comprise a water-soluble plastic film, for example, PVA films supplied by Chris-Craft Industrial Products, Inc. of South Holland, IL, under the designation MONOSOL M7031, M7030, M8630, M8534, E6030, or from. B. Fuller Company Paul, MN under the designation HL 1636 or HL 1669-X. For example, the film thickness may be modified to provide the desired activation. For example, the film used may have a thickness ranging from 0.00127 cm to 0.00292 cm. The HL 1636 film with a thickness of about 0.00254 cm will activate at a moisture content of about 0.049 / inch ² .

Alternatively, the actuator may include a current-sensitive gel. This gel is a polymeric gel network that changes volume and / or geometric shape after at least partially swelling with water after application of an electric field. Certain partially ionized polyacrylamide gels will, for example, have a concentration of about 50% under a weak electric field (e.g. 0.5 volt / cm) when immersed in acetone and water. Alternatively, electric-sensitive gels may be bent by electric current and in the presence of water and surfactant, or they may move in oscillating waves when subjected to an oscillating electric field. It is believed that it is possible to cause a loss in a portion of the gel, for example one side of the gel element, by concentrating the positively charged surfactant molecules on the negatively charged gel polymer in the electric field. By varying the field strength and / or polarity, movement in the gel is induced as the length of one of its sides decreases (the ribbon-shaped gel may twist). Current-sensitive gels can be in various shapes, rectangular, reticulated, circular, patterned to provide a "valve" to release material, also allow body waste to pass, prevent body waste from flowing, encapsulate body waste, etc. , because it changes volume and / or geometry. The electric current-sensitive gel in the form of a strip may bend to provide free space if it is in the muscle area ·· ·

At the outer anus there was detected electrical activity indicating the possibility of an emptying.

For example, FIGS. 5A and 5B show in the electrical circuit a strip of electrically sensitive gel 494, in which the moisture of the faeces may bridge the contacts 485 and thereby allow the current to flow to said gel, which bends or straightens under the current. The current-sensitive gel 594 formed in the form of a reticulated grid 595, as shown in Figs. 6A, 6B and 6C, can be electrically charged so that it swells or clots when urine discharge is detected, and in order to form a valve that allows urine to flow and / or to prevent it from flowing to another part of the article 20. FIG. FIGS. 6B and 6C further show a microscopic view of the grid in the swollen and contracted state. An exemplary material is crosslinked PAMP gel (poly (acrylamido-2-methylpropane) sulfuric acid). This type of gel can perform various functions, for example, to apply and deliver materials for the chemical treatment of faeces. Other exemplary electrosensitive gels are described in U.S. Pat. No. 5,100,933 issued to Tanaka on March 31, 1990 and in WO 9202005. pH-sensitive or salt-sensitive gels may alternatively be used as an actuator of the present invention.

The actuator may be disposed on or attached to any portion of the disposable product if that portion allows the actuator to perform responses to body waste, the user, the product and its components. For example, in the article 20, the actuator may be positioned in the front waist region 36, the back waist region 38, or the solution region 37 of the article 20, and may be integral with the body component 22 (may be located in close proximity to or may be joined), topsheet 24, backsheet 26, absorbent core 28, side panels 30, thigh cuffs 32, waist feature 34, fastening system 40, longitudinal or end edges 50, 52. Action the element may be completely positioned within the article 20, may have a portion located within the article and a portion outside the article 20, or may be entirely outside the article 20. The actuator, or portion thereof, may be operatively coupled to one or more sensors 60, to one or more drivers 80, to another part of the controller or to another part of the product 21, or may be otherwise installed by the user or caregiver.

The article 20 may also include an actuator. A "controller" is defined, for the purposes of this application, as a device that receives input from the sensor and determines whether one or more actions are to be performed. The controller may receive a signal from the sensor 60 and guide the actuator to perform a response function to the bodily waste, the user, the product and its components. The actuator can: • 9 · * · · · · ·

alternatively, receive a signal directly from the sensor 60 and perform a response function to the user, waste, product and its components. The actuator may include materials that are undergoing chemical or physical changes, it may be a chemical, mechanical, or electrical device that processes the sensor information, etc. The biosensor 60 may include a transducer comprising a multilayer Langmuir-Blodgett film, at least a portion of which may act as an actuator, wherein the one or more layers comprise a bio-recognition element. After contact with water, Langmuir-Blodgett films spontaneously reorganize, which is more pronounced in areas with more layers than the original film and other areas with fewer layers. This reorganization may expose the bio-recognition element to the environment, particularly in the presence of water, for example in body waste, which may contain a target biological analyte. This can reduce false positives and / or extend the life of the biosensor. An electrical controller that receives signals, such as electrical voltage from an electrochemical sensor, can receive and monitor multiple electrical signals, and can repeatedly trigger the actuator. The actuator may be integral with the actuator component, the sensor component, or may be a separate component of the system.

The actuator may be located on and / or attached to any portion of the disposable product that allows the actuator to receive the signal from the sensor 60 and pass it on to the actuator. In the article 20, the actuator may be located, for example, in the front waist area 36, the back waist area 38 or the crotch area 37 of the article 20, and further may be integral with, attached to, or proximate to the body 22, or attached to the topsheet component 24, the backsheet 26, the absorbent core 28, the side panels 30, the thigh cuffs 32, the waistband 34, the fastening system 40, the longitudinal or end edges 50, 52. The actuator may be integral with the product 20, or may be installed by a caregiver or user. The actuator may be housed in the article 20, may have a portion disposed within the product and a portion outside the product, or may be entirely disposed outside the product 20. The actuator or portion thereof may be operatively connected to one or more switches 60, one or more actuators 90 The article may, for example, receive a signal from the sensor 60 and provide it to the actuator, for example by radio frequency transmission.

Although the functions of the sensor 60, actuator and actuator may be performed by other structural elements, the functions of the sensor 60, actuator and / or actuator according to the present invention need not be realized by the other structural elements. For example, sensor 60 and controller functions may be realized by the same structure elements.

♦ * ···· ♦ * ···

-31 "Response System" for the purpose of this application is defined as a system that includes a sensor 60 and an actuator, and which operates on body waste, user, product or product component (s) when the sensor detects the appropriate trigger input . Upon removal of a given input parameter, the actuator realizes the release of stored energy or the release of stored material to perform the response function. For example, if a more active sensor 60 comprising a transducer detects an upcoming event, the transducer provides a signal to the actuator to release stored energy. By picking up the input signal before the upcoming event, the product response system can be started to prepare for the event, or it can transmit the upcoming event signal to the caregiver or user. This is allowed by the design of products where the waste handling or treatment technology is initially "hidden" or inconspicuous, but which is available at or near the time of need and / or in which the product can provide the caregiver or owner with the opportunity prepare for such event in advance (arrange for prophylactic treatment in case of detection of pathogenic microorganisms or residual excrement of faeces). Regardless of the particular input, in this embodiment, the sensor 60 may trigger an actuator to take action with the product, the user, or the environment to prepare for the occurrence of the event or to provide a signal to the attendant that the event will occur. If the sensor 60 comprises a sensory system, one actuator may trigger multiple sensors and / or signals. Alternatively, a single sensor and / or signal may trigger multiple actuators.

The response system may respond in either a continuous or discontinuous manner. The term continuous response system 'used in this application refers to a response system in which the output is quantitatively dependent on the amount of input, that is, a continuously increasing amount of input is required to produce continuously increasing amounts of output, or where the output system in response includes passive release of deposited material. For example, the superabsorbent polymer embedded in the absorbent core provides a smooth response in which the output is quantitatively dependent on the amount of input, i.e. when increasing amounts of liquid waste contact the superabsorbent polymer, increasing amounts of polymer retain fluid until the polymer capacity is depleted. . A stoichiometric chemical reaction is another example of a system with a continuous response to increasing output. In reaction A + excess B -> C, the amount of excess B converted to C is stoichiometric, and therefore "continuously", based on the amount A available in the system.

"Discontinuous response system", field of the present invention, refers to a response system having an output function substantially independent of the amount of input beyond the threshold. For example, when several values of a given input are reached, the response system can: • • The corresponding response function releases all or only a predetermined amount of stored energy, or delivers, which means actively delivering all or only a predetermined amount of stored material. In an ideal embodiment of the present invention, the output function f (x) includes a "step" function as shown in Fig. 3A. In this embodiment, the output change ratio as input (d) / d (input) increases ), i.e. the slope of the first derivative of f (x) of the output function F (x), is essentially zero if the amount of input is above or below the threshold. For the threshold value, the change in the d (output) / d (output) ratio is close to infinity. For an ideal discontinuous response, the limit of the function f (x- ε) at ε— »0 is not equal to the limit of the function f (x + s) at ε—> 0, ie lim f (xe) and lim (χ + ε) ε—> 0 ε— * 0

The present invention recognizes that in the world of physics an ideal step change at the threshold is not necessary and in many cases is not possible. In the preferred embodiment, it is only necessary for the output function to have a virtual step change with a small change at the input at or around the input threshold. The present invention contemplates a discontinuous response system having an output function that reacts in a sufficiently discontinuous manner in a transition region such that the output function has at least a minimum degree of slope in said transition region. Since the author does not wish to be limited to a particular method of describing or modeling a discontinuous system, in a preferred method of determining whether a given output function is implemented in a sufficiently discontinuous manner as defined for the purposes of the present invention, the slope of the output curve is compared the steepness of the line between the first and last point of the transition area. For example, Fig. 4A illustrates a graph of an exemplary output function f (x) together with the attached graphs of the first, second and third derivatives f '(x), f "(x), f" (x) of the output function f (x). The output function f (x) describes the effect of input (x or I) on the output or response (R (I)). For the purposes of this invention, the transition region is defined as the region between the relative maximum of R (Ii) and the minimum of R (L) of the second derivative of f (x) of the output function f (x). The relative maximum R (Ii) and the relative minimum R (l2) are the points at which the third derivative f '' (x) equals zero. The bending point Io is defined as the point in the transition region at which the second derivative f (x) equals zero, d ² R | dl ² | I = I ₀

The comparison of the steepness of the output function at the bend point with the steepness of the line between the first and last point of the transition region can be described by the equation:

· · ······ · · · · · · · · · · · · · · · · · · · · ·

-33 dR I (Δ _T R)

- I k = --- dl | I = Io (ΔΙτ)

In this equation, the expression dR / dl at the bend point is the first derivative of the output function at that point. The expression ΔΙτ represents the change in the input to the response system between the first li and the last I ₂ of the transition region, ie I2 if li, and the expression AR _T represents the change in the response of the output function between the first and last point of the transition region. IR (Ii). The coefficient k is a relative constant that describes the relative steepness of the slope of the output function at the bend point Io when compared to the slope of the line between the first and last point of the transition region. In order for the response system to have a discontinuous output function, the relative constant to the value must be at least 5.0, preferably about 3.0, even more preferably about 5.0, preferably about 10.0, while a value of about 100.0 is best ever.

In certain embodiments, the relative degree of steepness in the transition region of the discontinuous response system may be modeled by the transmission function of a control system comprising a series of integers with first order delays with the same time constants. The transmission function of the response system is defined, for the purposes of the present invention, as the ratio of the Laplace transform of the output (positive response variable) to the input (interference variable). See, for example, Robert H. Perry & Don Green, Perrys Chemical Engineers Handbook, Sixth Edition, Chap. 22 (McGraw Hill, Inc. 1984). According to Fig. 4B, the relative degree of steepness of the output function can be approximated by the formula: KG (s) = K / (Ts + 1) ⁿ , where KG (s) is a transfer function, K is a ratio element, T is a system time constant an integer of the first order of the time delay. In this model, if n increases, the steepness of the transition region output function increases and the model begins to approximate the discontinuous response system. Certain discontinuous response systems of the present invention should be modeled using the above formula when n is greater than or equal to 25, with n being greater than or equal to 50, more preferably greater than or equal to 100.

Referring to Fig. 3A, the response system of the present invention may include a single threshold value (level) at which the response system may release all stored energy to perform a specific response function, or may include multiple thresholds at which the system may release a predetermined amount of stored energy to perform one or more specific response functions at each threshold. For single threshold designs, the response system may release, for example, to perform the entire response function.

-34All stored energy when the threshold is reached. In such a single threshold embodiment (in this example), the discontinuous response system includes a system that can be in two states, on or off. If an absorbent article has a threshold of input, such as a target biological material, the response system may perform a single response function for the waste, the user, the article and its components, such as encapsulating the waste and separating it from the user's skin, or providing a readily detectable visual signal to the user. or caregiver. A discontinuous response system can perform a pseudo-switching function, one that changes from one state to another in the presence of an input threshold.

Referring to Fig. 3B, the response system may alternatively include a plurality of thresholds at which the system may, when each threshold is reached, release a given "quantum" of energy, or may deliver a given amount of material to perform a specific response function. In this embodiment, when each threshold is reached, part of the entire response function can be performed and / or various independent response functions can be performed in response to reaching different threshold values. For example, the response system may monitor the faecal enzyme and if each enzyme threshold is reached, the system may provide the same or unequal amounts of enzyme or lotion inhibitor, or may provide a pH buffer at the first threshold, and also perform a different response function, for example, supplying a plurality of inhibitors upon reaching the second threshold.

In each transition region, the response system responds substantially the same as the transition region in the single threshold embodiment as described.

In addition, the response system may monitor a number of inputs, for example one or more pathogenic bacteria, and / or one or more fecal enzymes, and perform one or more response functions when different input thresholds are reached, or may perform only one response function if one or more thresholds of different inputs are reached. Thus, the controller can monitor many different inputs and perform different response functions if the thresholds are reached for said inputs. Alternatively, the controller may perform the logic functions of the summation element such that the response function may be performed when one or more multiple input thresholds are reached. The controller may also perform logic product functions such that a response function may be performed when each threshold of two or more different inputs is reached.

The response system may also include a "closed loop" or "open loop" system. The "closed loop" system, also called the "control loop" system, is known as the "closed loop" system. · · ···· · · ······ · «« · · • · · · · · · · · · · · · · · · · ·

Feedback feedback includes another sensor 60 and actuator components, and performs a response function at the input. In a preferred embodiment, the system may also use sensing or measuring the element or parameter of the output conditions, for example, it may take at least one trigger of the response function performed at the input. The output conditions may be the input condition state after the actuator has been able to perform the input condition response function. The response function can be performed when the output conditions reach a threshold, or can only be performed when the output condition and one or more conditions are met. The input activity may include activity on a perceived element, for example by perception of a microorganism and an activity on an organism, or activity on a mixture whose perceived element is an integral component, for example perception of faecal bacteria and activity on faecal matter or residual excrement on the user's skin. has been described. The feedback loop control system comprises at least two different components: a sensor 60 and an actuator. The sensor 60 senses an event or parameter associated with such an event. The actuator receives a signal and performs an input condition response function sensed by the sensor 60. The feedback control loop may further include an actuator. In this case, the sensor 60 provides a signal to the controller, and the controller may cause the actuator to perform an input condition response function. The actuator may be a separate component of the response system, or the actuation function may be performed by the sensor 60 and / or actuator.

The feedback control loop can be “unmodulated” or “modulated”. For a response system with an unmodulated feedback control loop, the response system acts as an instantaneous switch whereby the actuator performs an input response function when the output condition threshold is reached. For example, the sensor 60 may detect the presence, or measure, the concentration of a specific pathogenic organism, and the actuator may signal to the attendant the onset of an initial infection. In this case, the actuator operates at the input detected by the sensor 60. The modulated feedback control loop includes the sensor 60, the actuator, and the controller. In a modulated feedback loop, the output condition is monitored continuously and repeatedly, with the controller directing the actuator to perform an input response function to maintain the output condition at a given set point, or within a range considered, or to provide a continuous measurement of values, or concentration, of the target biological analyte.

An “open loop” system is a system that responds to an input to perform a feedback function without using feedback, that is, the output has no effect on the perceived input that enters the system. The open-loop system may include a response system having a single device performing functions of both sensor 60 and function

-36 · · · · · · ak ku nebo nebo nebo nebo nebo nebo nebo nebo nebo nebo nebo nebo nebo nebo nebo nebo nebo nebo nebo may have another sensor 60 and actuator components, wherein the actuator operates on something other than the input. The superabsorbent polymer disposed in the absorbent core of the disposable absorbent article provides an open loop response since the polymer comprises only one device that performs the functions of the sensor 60 and the actuator. Alternatively, the open-loop response system may include a sensor 60 that senses the presence of body waste or body waste components, and an actuator performing the response function in a continuous or discontinuous manner, at something other than the input detected by the sensor 60.

Other response systems are described in U. S. Patent Application 09 / 106,424, entitled " Disposable Article Having A Discontinuous Responsive System ", filed June 29, 1998 (P & G Time Number 7197), filing an application. 09 / 107,563 entitled "Disposable Article Having a Responsive System Including A Feedback Control Loop" filed June 29, 1998 (P&G Time Number 7198), and 0/9106, 225, entitled " Disposable Article Having A Responsive System Including A Mechanical Actuator ", filed June 29, 1998 (P&G Time Number 7199, all of which are incorporated herein by reference.

An example of a diaper 20 according to the present invention may include a response system comprising the sensor 60 of Figure 1 and the actuator of Figure 2. In this embodiment, the transducer 60 may include a transducer operatively associated with a bio-recognition element adapted to detect E. coli in faeces. Upon detection of the e. Coli threshold by the bio-recognition element, the transducer to the actuator signals this condition by means of electric current. The article of Fig. 1 may include an actuator that includes a compressed resilient material 94 vacuum sealed under a film 91 that is water soluble (see Fig. 2), for example, under a PVA film. Upon obtaining the correct signal from the sensor, the actuator may close the switch, for example, release a small amount of stored water for contact, as well as to dissolve the water-soluble film. 91 This results in the release of stored mechanical energy in the compressed foam. The resilient material 94 swells to form a cavity for the occurrence of faeces. The transition closure may alternatively and additionally release an antimicrobial to control E. coli and / or a water-soluble visible dye as a signal to the attendant of the presence of E. coli. In another embodiment, the response system may include an actuator that provides a caregiver or user for an upcoming event, for example, diarrhea infection or skin irritation (candidiasis).

♦ 99 · 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9

9 9 9 9 9 9 99 9 9 999 9

In an alternative embodiment, the invention may include a partial covering of a body, for example a hand, that can detect and alert the user to specific biological conditions. Covering the hand means partially covering the hand or any other part of the body. The sensor is preferably located near or near a portion of the outer surface. Examples of hand covering devices include, but are not limited to, finger protectors, gloves, mittens, and hand covers. It is preferred that the compositions are disposable compositions. Such compositions are used in medical treatment, veterinary care, agriculture in connection with animal and plant products, in domestic food preparation and animal production.

In another embodiment, the invention may also include the handling, storage and preparation of food-related products for humans and animals that can detect and alert the caregiver of specific biological conditions. Disposable products are preferred. Preference is given to positioning the sensor at or near a portion of the surface that is expected to come into contact with food. The product can be used both in handling raw foods at various stages of preparation as well as in conjunction with finished foods. Such products may include various food preparation aids, such as blankets and boards, whether rigid or flexible, food storage materials, such as rigid containers, rigid container liners, packages of rigid or flexible material, as well as products serving food, such as plates, bowls, and the like, all of rigid or resilient material that act as replacement plates.

Method of testing

Response factor test

Using the response factor test, as described, the response of a quantitative sensor can be measured in response to the occurrence of a specific component or mixture.

Specific components or mixtures for which this test is suitable include: test faecal material in aqueous solution at a concentration of 1g test faecal material per g saline saline test faecal material in a urine solution at a concentration of 1g faecal material per g urine test solution ,

Skatol solution in physiological saline at a concentration of 180 micrograms skatol per gram of physiological saline.

All measurements are made at body temperature (37 ° C). The testing method includes the following steps in a specified sequence:

· ·? ·?????????????????????????? · · »» »» »

1) Record the quantitative response of the sensor after physiological saline treatment for 24 hours. The background response is the maximum recorded response.

2) Exposing the sensor to a specified component or mixture.

3) Record the quantitative response of the sensor while still exposed to a specific component or mixture for 24 hours. The component response is the maximum response recorded.

The response factor is obtained by normalizing the component response by the background response. In the case where the response factor is less than 1, the reciprocal value of the response factor is reported as the response factor.

While particular embodiments and / or individual features of the invention have been described and illustrated, it will be apparent to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. Although the present invention is illustrated and described primarily in the form of a diaper, the present invention is not limited to this kind of article. The present invention can also be applied, for example, to products that are applied directly to the body of the user (in the perianal and perineal region of the user) prior to disposable diaper application, or instead of disposable diaper, diaper diaper, diaper pad, It is further understood that all combinations of these embodiments and features are possible that may lead to a preferred embodiment of the present invention. The appended claims are intended to cover all possible changes and modifications within the scope of the invention.

Claims (28)

PATENT CLAIMS A disposable article that is attached to a user's body, comprising: a biosensor comprising at least a bio-recognition element, wherein the sensor is adapted to detect a target biological analyte in body waste or on the user's skin. The disposable article of claim 1, wherein the bio-recognition element comprises a biologically reactive substance. The disposable article of claim 1, wherein the biosensor is selected from the group of: biocatalytic biosensors and affinity biosensors, wherein the affinity biosensors are preferably selected from chemoreceptor and immunoassay based biosensors. A disposable article according to any one of the preceding claims, wherein the bio-recognition element is selected from: an enzyme or enzyme sequence, antibody, DNA, organelle, membrane receptor protein, viable or naturally-viable cell membrane, viable. or non-viable bacteria, plants, animal cells, at least a portion of the nerve nodules, and at least a portion of the sensory organs, of Arcinetobacter baumannii TOI36 from Bacillus sp TOI41. A disposable article according to any one of the preceding claims, wherein the bio-recognition element is located on a substrate selected from the group: polymer-based materials, hydrogels, tissue paper, nonwoven materials and woven materials. The disposable product of any one of the preceding claims, wherein the biosensor detects target biological analytes selected from the group of: pathogenic bacteria, colonic bacteria, viruses, parasites, bacterial toxins, functions, enzymes. The disposable product of claim 6, wherein the pathogenic bacterium is selected from: Escherichia coli, Salmonella typhi, Salmonellaparatyphi, Salmonella enteriditis, Salmonella typhimurium, Salmonella heidelberg, Shigella sonnei, Shigella flexneri, Shigella dysentia, Shigella dysentia Vibrio chlerae, Mycobacterium, and · · · · · · «· · · -40tuberculosis, Yersinia entorocolotica, Aeromonas hydrophila, Plesiomonas shigellosides Campolybacter jejuni, Campylobaccter coli, Bacteroides frfagilis, Closttridia perfringens, Clostridia butulinum, and Clostridia difficile. A disposable product according to any one of the preceding claims, wherein the biosensor detects a target biological analyzer associated with the systemic or medical condition of the skin in the user prior to the onset of clinically observable symptoms of the condition. The disposable article of any preceding claim, wherein the biosensor further comprises a transducer, preferably selected from the group consisting of electromechanical, optical, thermal and acoustic transducers. The disposable article of any preceding claim, wherein the article further comprises a biosensor cleaning element. Disposable article according to any one of the preceding claims, characterized in that the biosensor is attached to the support element and / or is detachable from the article. The disposable article of any preceding claim, wherein the bio-sensor or support element adheres to the user's skin. The disposable article of any preceding claim, further comprising an actuator that performs a response function at the time the biosensor detects the target biological analyzer, wherein the response function is preferably a signal to the caregiver or user. The disposable article of claim 13, wherein the response function is one or more functions selected from the group consisting of: void volume, skin care, foam system, and caregiver signals. A disposable article according to any preceding claim, further comprising a receiver and / or a transmitter. «· I I I 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 «· A disposable article according to any one of the preceding claims, wherein the biosensor has a response factor of at least 5 when exposed to faeces, preferably at least 10 when exposed to faeces, and preferably 20, is if also exposed to faeces. The disposable product of any preceding claim, wherein the biosensor has a response factor of at least 5 when exposed to a solution of skatol in physiological saline at a concentration of 180 micrograms of skatol per gram of physiological saline. 18. A disposable article intended to be attached to a user's body comprises: a sensor adapted to detect health or nutrition indicators in the user's body waste or on the user's skin. The disposable product of claim 18, wherein the health indicator is selected from the group of: heavy metals, radioactive substances, fats, enzymes, endogenous secretions, protein substances, mucus, and microorganisms. 20. The disposable article of claim 19 wherein the heavy metal is lead or mercury. The disposable product of claim 18, wherein the nutrient indicator is selected from the group consisting of calcium, vitamins, electrolytes, fats, fatty acids, soaps, amino acids, enzymes, bile acid and its salts, steroids and carbohydrate wires. The disposable product of claim 18-21, wherein the sensor detects a target health indicator and / or a nutrition indicator associated with the health and nutritional status before the onset of clinically observable symptoms of the conditions or when the biosensor detects a target health or nutrition indicator that is above a predetermined threshold. -42 ·· »· · · · ·« «· · · · · · · · · · * φ »· The disposable article of claim 18-22, wherein the sensor further comprises a transducer selected from the group consisting of electrochemical, optical, thermal and acoustic transducers. The disposable article of claim 18-23, wherein the sensor comprises a microchip. The disposable article of claim 18-24 further comprising an actuator that performs a response function when the sensor detects a health or nutrition indicator. The disposable article of claim 25, wherein the actuator converts potential energy to perform a response function, wherein the potential energy is one or more of a mechanical, electrical, or chemical energy. A disposable article according to any one of the preceding claims, further comprising: a topsheet, a backsheet joined to the topsheet, an absorbent core positioned between the topsheet and the backsheet. The disposable article of any of the preceding claims, wherein the disposable absorbent article belongs to a product group: sanitary napkins, diapers, training pants, sanitary napkins and adult incontinence products.