KR20010053327A - Disposable article having bodily waste component sensor - Google Patents

Abstract

The present invention relates to a disposable product comprising a sensor adapted to detect one or more specific biological health markers and / or nutritional markers in the stool of the wearer. The product may also signal the guardian, wearer or actuator if the above situation occurs.

Description

Disposable product with sensor for component of body secretion {DISPOSABLE ARTICLE HAVING BODILY WASTE COMPONENT SENSOR}

Today, disposable products such as diapers, adult incontinence briefs, sanitary napkins and tampons are widely used as a means of receiving, isolating and discarding body secretions in caring for infants and toddlers or caring for adult incontinence. These products have generally replaced garments made of reusable and washable cloth as a preferred means for such applications because of their convenience and reliability. The disposable product copes by absorbing or receiving body secretions deposited on the product upon defecation, urination or excretion. Some disposable products also signal this after defecation, urination or excretion has occurred (eg, an indication of wetting or detection of temperature changes). Other disposable absorbent articles known in the art include means for chemically reacting to detect various substances (eg pH or ions) in the wearer's secretions (eg urine). However, none of these products detect potentially pathogenic target microorganisms such as bacteria, viruses, fungi and parasites (e.g. protozoa) and / or associated biomolecules, all of which are highly sensitive to purified chemical agents. It requires selectivity (ie specificity) and sensitivity. In addition, none of these clearly detect the chemical composition of the wearer's stool, which acts as a marker for potential health problems and / or nutritional status. In addition, the products do not foresee when a health- or nutrition-related problem is about to occur, and do not signal the wearer or caregiver in need of preventing or treating the problem before the onset of clinically observable symptoms.

Summary of the Invention

The present invention relates to a disposable product that is matched to a wearer, the biosensor being configured to detect biological target analytes in body secretions or on the skin of the wearer and comprising one or more bio-cognitive elements. The present invention relates to a disposable product that is matched to a wearer, the sensor comprising a sensor adapted to detect a health indicator or nutritional marker in the wearer's body secretion or on the wearer's skin.

The present invention relates to a biosensor having a bio-recognition element for detecting microorganisms and / or biomolecules in disposable products, more specifically body secretions, and / or health markers. And / or sensors that are useful as nutritional markers and have sensors adapted to detect and / or measure components of feces.

1 is a plan view of a product made in accordance with the present invention in a state in which a portion of the structure is cut and unfolded to more clearly show the structure of the product, where the product is a diaper.

2 is a perspective view of the body secretion isolation device of the present invention in a compressed state prior to activation.

2A shows a cross-sectional view taken along line 2A-2A in FIG. 2.

Figure 3a shows an ideal output function of the discrete response system of the present invention with one threshold.

Figure 3b shows the ideal output function of the discrete response system of the present invention with multiple thresholds.

4A shows an example of the output function and its first, second and third derivatives of the discrete response system of the present invention.

4b shows the transfer function of a control system having a series of first order parallaxes with the same time constant.

5A and 5B illustrate aspects of the response system of the present invention comprising an electrosensitive gel.

6A, 6B and 6C show another embodiment of the response system of the present invention comprising an electrosensitive gel.

7 is a perspective view of a secretion bag embodiment of the present invention.

8 is a perspective view of one embodiment of a diaper including a secretion bag.

As used herein, the term "absorbent product" refers to a device that absorbs and receives body secretions, and more specifically, a device that absorbs and receives various secretions discharged from the body facing or adjacent to the wearer's body. . The term "disposable" as used herein describes an absorbent product that is generally not washed, otherwise restored or reused as an absorbent product (ie, discarded after one use, preferably recycled, composted, or environmented to the environment). Arranged otherwise in a suitable manner). (The term "placed" as used herein means that the element (s) of the diaper is formed at a specific place or location as a unitary structure with other elements of the diaper or as a separate element coupled to another element of the diaper. As used herein, the term "coupled" is used in the form of directly attaching one element to another, thereby directly fixing the element to another element, and one element. To indirectly secure the element to another element by attaching to the intermediate member (s), which in turn attaches it to the other element). "Single" absorbent article refers to an absorbent article formed of such separate components that separate components are joined together to form an integrated whole that does not require separate operating parts such as separate holders and liners. A preferred embodiment of the absorbent article of the present invention is a single disposable absorbent article, such as the diaper 20 shown in FIG. As used herein, the term "diaper" generally refers to an absorbent article that is worn around the lower torso by infants and incontinents. The invention also relates to other absorbent or non-absorbent products, such as incontinence briefs, incontinence underwear, absorbent inserts, diaper holders and liners, disposable bed pads, and colostomy bags for natural or colostomy. , Feminine hygiene garments, tampons, wipes, disposable towels, tissues, bibs, water absorbent products, oil absorbent products, spill cleanup bags, desiccant bags, disposable mops, bandages, disposable It can be applied to medical garments, disposable plates and cups, disposable food products and cutting surfaces, therapeutic wraps, supports, disposable heating pads and the like.

1 is a plan view of the diaper 20 of the present invention in a partially cut and unfolded state in order to more clearly show the structure of the diaper 20. The portion of the diaper 20 facing the wearer is oriented towards the viewer. As shown in FIG. 1, the diaper 20 preferably includes a liquid permeable top sheet 24; Liquid impermeable backsheet 26; An absorbent core 28 (preferably disposed between the top sheet 24 and at least a portion of the back sheet 26); Side panels 30; Elasticized leg cuffs 32; Elastic waist feature 34; And fixation system 40 as shown generally. The diaper 20 has a first waist region 36 in FIG. 1, a second waist region 38 opposite the first waist region 36, and a crotch disposed between the first waist region and the second waist region. It is shown to have an area 37. The periphery of the diaper 20 has a longitudinal edge 50 lying generally parallel to the longitudinal center line 100 of the diaper 20 and the end edge 52 has a lateral center line 100 of the diaper 20. It is defined by the outer edges of the diaper 20 lying between the longitudinal edges 50, which are generally parallel to.

The body portion 22 of the diaper 20 includes the main body of the diaper 20. Body portion 22 comprises an outer covering layer comprising at least a portion of absorbent core 28 and preferably top sheet 24 and back sheet 26. If the absorbent article includes separate holders and liners, body portion 22 generally includes the holders and the liners. (For example, the holder may comprise one or more layers of material forming the outer covering of the article, and the liner may comprise an absorbent assembly comprising a topsheet, a backsheet and an absorbent core. The holder and / or liner may comprise a securing element that is used to hold the liner in place throughout the time of use.) In a single absorbent article, the body portion 22 is adapted to form a composite diaper structure. The main structure of the diaper with other features applied. Although the topsheet 24, backsheet 26 and absorbent core 26 may be assembled in a variety of well known forms, a preferred diaper form is given to Kenneth B. Buell, dated January 14, 1975. US Patent No. 3,860,003 entitled "Contractible Side Portions for Disposable Diaper" for disposable diapers; US Patent No. 5,151,092 to Buell, dated September 9, 1992; US Patent No. 5,221,274, issued to Buell on June 22, 1993; "Absorbent Article With Multiple Zone Structural Elastic-Like Film Web Extensible Waist Feature," issued to Roe et al. On September 10, 1996. US Patent No. 5,554,145, entitled Iran; U.S. Patent 5,569,234 entitled "Disposable Pull-On Pant" to Buell et al. On October 29, 1996; United States Patent No. 5,580,411 entitled "Zero Scrap Method For Manufacturing Side Panels For Absorbent Articles," issued to Nease et al. On December 3, 1996. ; And US patent application Ser. No. 08 / 915,471 filed "Absorbent Article With Multi-Directional Extensible Side Panels," filed August 20,1997. These are respectively incorporated by reference into the present invention.

The backsheet 26 is generally placed adjacent to the garment-directed surface 45 of the absorbent core 28, for example products in which secretions absorbed and contained in the absorbent core may come into contact with the diaper 20, for example. For example, it is a part of the diaper 20 which prevents soiling of the bed sheet and underwear. The backsheet 26 may be coupled to the topsheet 24, the absorbent core 28, or any other element of the diaper 20 by any attachment means known in the art. Suitable backsheet films include those made by Tredegar Industries Inc. of Terre Haute, IN and sold under the trade names X15306, X10962 and X10964. Other suitable backsheet materials include breathable materials such as woven webs, nonwoven webs, composite materials (eg film-coated nonwovens) and ESPOIR NO manufactured by Mitsui Toatsu Co., Japan, for example; Microporous films such as EXXAIRE manufactured by EXXON Chemical Co., Bay City, Texas; Or monolithic films made under the tradename HYTREL Blend P18-3097 by Clopay Corporation, Cincinnati, Ohio. Such breathable composite materials are disclosed in PCT Application WO 95/16746, published under the name of E. I. DuPont, dated June 22, 1995; Co-pending US Pat. No. 5,865,823, issued to Curro on February 2, 1999; It is described in more detail in US Pat. No. 5,571,096 to Dobrin et al. On November 5, 1996. Each of these references is incorporated herein by reference.

The backsheet 26 or any portion thereof is elastically stretchable in one or more directions. In one embodiment, the backsheet 26 may comprise a structural elastic-like ("SELF") web. Structural elastic-like film webs are stretchable materials that exhibit elastic-like behavior in the stretching direction without the addition of elastic materials. SELF webs suitable for the present invention are described in US Pat. No. 5,518,801, entitled "Web Materials Exhibiting Elastic-Like Behavior," issued to Chappell et al. More fully disclosed herein. In another embodiment, the backsheet 26 may comprise an elastomeric film, foam, strand, or a combination of these or other suitable materials with a nonwoven or synthetic film.

The topsheet 24 is preferably compliant, gives a soft feel, and does not irritate the wearer's skin. Furthermore, at least a portion of the topsheet 24 may be liquid permeable to allow liquid to easily penetrate through the thickness of the topsheet. Suitable topsheets 24 include porous foams, reticulated foams; Perforated flexible film; Or from a wide range of materials, such as woven or nonwoven webs of natural fibers (eg, wood or cotton fibers), synthetic fibers (eg, polyester or polypropylene fibers), or blends of natural and synthetic fibers. . If the absorbent assembly comprises a fiber, the fiber may be subjected to spunbond, card, wet lamination, meltblown, hydroengle or other processing as known in the art. One suitable topsheet 24 comprising a staple length polypropylene fiber web is Veratec, Inc., Division of International Paper Company, Walpole, Mass., USA. Is sold under the trademark P-8.

Suitable molded film topsheets are disclosed in the following patent literature: a US patent entitled "Absorptive Structures Having Tapered Capillaries" issued to Thompson on December 30, 1975. 3,929,135; 3,929,135; U.S. Patent No. 4,324,246, entitled Disposable Absorbent Article Having A Stain Resistant Topsheet, issued to Mullan on April 13, 1982; US Patent No. 4,342,314, entitled "Resilient Plastic Web Exhibiting Fiber-Like Properties," issued to Radel et al. On August 3, 1982; Macroscopically Expanded Three-Dimensional Plastic Web Exhibiting Non-Glossy, by Ahr et al., Dated July 31, 1984. US Patent No. 4,463,045 entitled "Visible Surface and Cloth-Like Tactile Impression"; And US Pat. No. 5,006,394 to "Multilayer Polymeric Film" issued to Baird on April 9, 1991. Other suitable topsheets 30 are manufactured according to US Pat. Nos. 4,609,518 and 4,629,643 to Curro et al. On September 2, 1986 and December 16, 1986, respectively, all of which are incorporated herein by reference. Is cited. These molded films were "DRI-WEAVE" from The Procter & Gamble Company, Cincinnati, Ohio, and Tredegar Corporation, Terre Hout, Indiana, USA. ) As "CLIFF-T".

Preferably, the topsheet 24 is made of or treated with a hydrophobic material to separate the wearer's skin and the liquid contained in the absorbent core 28. When the topsheet 24 is made of hydrophobic material, it is desirable to treat one or more top surfaces of the topsheet 24 to be hydrophilic to allow liquid to move more easily through the topsheet. This reduces the likelihood that body feces will flow out of the topsheet 24 rather than being pulled through the topsheet 24 and absorbed into the absorbent core 28. The topsheet 24 can be made hydrophilic by treating the surfactant therewith or incorporating the surfactant into the topsheet. Suitable methods for treating the topsheet 24 with a surfactant include spraying a surfactant onto the topsheet 24 material and dipping the topsheet material in the surfactant. A more detailed discussion of such treatment and hydrophilization is given to Reising et al. On January 29, 1991, entitled "Absorbent Articles with Multiple Layer Absorbent Layers." 4,988,344 and US Patent No. 4,988,345 entitled "Absorbent Articles with Rapid Acquiring Absorbent Cores" issued to Racing on January 29, 1991. A more detailed discussion of some suitable methods of incorporating surfactants in topsheets can be found in US Statutory Invention Registration H1670, published July 1, 1997, in the name of Aziz et al. Each of these documents is incorporated herein by reference.

Any portion of the topsheet 24 or other components of the article may be treated with a lotion as is known in the art. Suitable lotions are, for example, Disposable Absorbent Article Having A Lotioned Topsheet Containing, which is given to Roe on March 4, 1997, containing "softeners and polyol polyester fixatives. US Em. No. 5,607,760 entitled "An Emollient and a Polyol Polyester Immobilizing Agent"; Named "Diaper Having A Lotion Topsheet Comprising A Liquid Polyol Polyester Emollient And An Immobilizing Agent", issued March 11, 1997 to Lowe. US Patent No. 5,609,587; United States Patent Nos. 5,635,191 entitled "Diaper Having A Lotioned Topsheet Containing A Polysiloxane Emollient," issued June 3, 1997 to Rowe, and July 1997. US Pat. No. 5,643,588, entitled "Diaper Having A Lotioned Topsheet," issued to Row on the 1st. The lotion may act alone or in combination with another agent by the hydrophobization treatment described above. The topsheet may also include or treat an antimicrobial agent, some examples of which include the absorption of an antimicrobial agent in the topsheet for controlling odor, published September 14, 1995 in the name of Theresa Johnson. International Publication No. WO 95/24173 entitled "Absorbent Articles Containing Antibacterial Agents in the Topsheet For Odor Control". Furthermore, the topsheet 24, backsheet 26, or any portion of the topsheet or backsheet can be embossed and / or matte-like finished to provide a more cloth-like appearance.

The topsheet 24 and the backsheet 26 may be coupled to each other by any attachment means known in the art and may be coupled to the absorbent core 28 or any other element of the diaper 20. For example, the attachment means may comprise a uniform continuous layer of adhesive, a patterned layer of adhesive, or an arrangement of separate lines, spirals or dots of adhesive. Alternatively, the attachment means may comprise thermal bonds, compression bonds, ultrasonic bonds, power mechanical bonds or any other suitable attachment means or a combination of these attachment means known in the art.

Absorbent core 28 may generally include any absorbent material that is compressible, comfortable, and capable of absorbing and retaining liquids, such as urine and certain other body excretion, without irritating the wearer's skin. Absorbent core 28 can be manufactured in a variety of sizes and shapes (e.g., rectangular, hourglass, "T", asymmetric, etc.), disposable diapers and other such as crushed wood pulp, commonly referred to as air felt. It may include a wide range of liquid absorbent materials conventionally used in absorbent articles. Other suitable absorbent materials such as creped cellulose wading; Meltblown polymers including cofoum; Chemically reinforced, modified or crosslinked cellulose fibers; Tissue, including tissue wraps and tissue laminates; Absorbent foams; Absorbent sponges; Superabsorbent polymers; Absorbent gelling materials; Or any other known absorbent material or combination of materials.

The shape and structure of the absorbent core 28 may also vary (eg, the absorbent core (s) or other absorbent structure (s) may have various caliper bands, hydrophilic gradients, superabsorbent gradients or low average density and low average). May have a capture zone of basis weight, or may include one or more layers or structures). However, the total absorbent capacity of the absorbent core 28 should be compatible with the design load of the diaper 20 and its intended use.

Examples of absorbent structures for use as absorbent assemblies are described in the following patent literature, which is incorporated herein by reference: "High-Density Absorbent Structures, issued to Weisman et al. On September 9, 1986. US Patent No. 4,610,678 entitled "); US Patent No. 4,673,402 entitled "Absorbent Articles With Dual-Layered Cores" issued to Weissman et al. On June 16, 1987; May 30, 1989 to Alemany et al, "High Density Absorbent Members Having Lower Density and Lower Basis Weight Acquisition Zones." U.S. Patent 4,834,735, designated; US Patent No. 4,888,231 entitled "Absorbent Core Having A Dusting Layer" to Angstadt, dated Dec. 19, 1989; US, entitled "Absorbent Structure Containing Individualized, Polycarboxylic Acid Crosslinked Wood Pulp Cellulose Fibers," issued to Herron et al. On August 11, 1992. Patent number 5,137,537; US Patent No. 5,147,345 entitled "High Efficiency Absorbent Articles For Incontinence Management," issued to Young et al. On September 15, 1992; US Patent No. 5,342,338, entitled Disposable Absorbent Article For Low-Viscosity Fecal Material, issued to August 30, 1994; "Absorbent Foam Materials For Aqueous Body Fluids and Absorbent Articles Containing Such Materials," issued to Desmarais et al. On November 9, 1993. US Patent No. 5,260,345, entitled; Dyer et al., Feb. 7, 1995, "Thin-Until-Wet Absorbent Foam Materials For Aqueous Body Fluids And Process For Making Same US Patent No. 5,387,207 entitled "); And Absorbent Foam Materials For Aqueous Fluids Made From High Internal Phase Emulsion Having, issued July 22, 1997 to Desmarice. US Patent No. 5,625,222 entitled "Very High Water-To-Oil Ratios."

The diaper 20 may also include one or more elastic waist features 34 that help to provide improved mating and retention characteristics. The elastic waist feature 34 preferably extends at least longitudinally outward from one or more waist edges 62 of the absorbent core 28, and generally extends at least a portion of the end edge 52 of the diaper 20. It is common to form. Disposable diapers are often made to have two elastic waist features located in the first waist region 36 and elastic waist features located in the second waist region 38. Further, although the elastic waist feature 34 or one of its components may include one or more separate elements attached to the diaper 20, the elastic waist feature 34 may include a backsheet 26, a topsheet. 24, or as an extension of other elements of the diaper 20, such as both the backsheet 26 and the topsheet 24.

Elastic waist features 34 can be manufactured in a number of different shapes, including those described in the following patent documents: US Pat. No. 4,515,595, issued to Kivit et al. On May 7, 1985; U.S. Patent No. 4,710,189 to Lash as of December 1, 1987; U.S. Patent No. 5,151,092 to Buell, Sep. 9, 1992; And US Pat. No. 5,221,274, issued to Buell on June 22, 1993. Other suitable waist shapes include those described in US Pat. No. 5,026,364 to Robertson on June 25, 1991 and US Pat. No. 4,816,025 to Foreman on March 28, 1989. A waistcap feature. All of the foregoing features are incorporated herein by reference.

The diaper 20 may also include a fixation system 40. The fastening system 40 preferably includes tape tap and / or hook and loop fastening components, although any other known fastening means may generally be acceptable. Some exemplary fixation systems are disclosed in U.S. Patent No. 3,848,594 entitled "Tape Fastening System for Disposable Diaper," issued November 19, 1974 to Buell; US Patent No. B1 4,662,875 entitled "Absorbent Article" to Hirotsu, dated May 5, 1987; US Patent No. 4,846,815, entitled "Disposable Diaper Having An Improved Fastening Device," issued to Scripps on July 11, 1989; US Patent No. 4,894,060 entitled "Disposable Diaper With Improved Hook Fastener Portion," issued to Nestgard, January 16, 1990; US Patent No. 4,946,527 entitled "Pressure-Sensitive Adhesive Fastener And Method of Making Same" issued to Batrell on August 7, 1990; And US Pat. No. 5,151,092 to Buell, Sep. 9, 1992, which was previously incorporated herein by reference; And US Pat. No. 5,221,274, issued to Buell on June 22, 1993. The fixation system may also provide a means for keeping the product in a waste form, as described in US Pat. No. 4,963,140 to Robertson et al. On October 16, 1990. Each of these patent documents is incorporated herein by reference. In another aspect, the pants may be made by sewing or pasting opposite sides of the garment. This allows the product to be used as a pull-on type diaper, such as a training pant.

The diaper 20 may also include a side panel 30. The side panel 30 is elastic or stretchable such that the elastic side panel 30 allows the sides of the diaper 20 to expand and contract so that the diaper 20 is initially comfortable with the wearer. By maintaining this consistency for long periods of wear after the feces are loaded in 20), more comfortable and contoured matching can be provided.

The diaper 20 of the present invention preferably has a side panel 30 disposed in the second waist region 38, but the diaper 20 has a first waist region 36 or a first waist region 36 and It is possible to provide a side panel 30 disposed in both of the second waist regions 38. The side panel 30 can be manufactured in any suitable form. Diapers with elasticized side panels are described, for example, in U.S. Pat. 4,857,067; US Patent No. 4,381,781 to Sciaraffa et al. On May 3, 1983; US Patent No. 4,938,753 to Van Gompel, issued July 3, 1990; U.S. Patent No. 5,151,092 to Buell, Sep. 9, 1992, which was previously incorporated herein by reference; And US Pat. No. 5,221,274, issued to Buel on June 22, 1993; US Patent No. 5,669,897 entitled "Absorbent Articles Providing Sustained Dynamic Fit" to LaVon et al. On Sep. 23, 1997; US Patent Application No. 08 / entitled "Absorbent Article With Multi-Directional Extensible Side Panels" filed November 19, 1993, in the name of Robles et al. 155,048; Each of which is incorporated herein by reference.

The diaper 20 preferably further includes leg cuffs 32 that provide improved retention of liquids and other body excretion. Leg cuffs may also be referred to as leg bands, side flaps, blocking cuffs, or elastic cuffs. U. S. Patent No. 3,860, 003 describes a disposable diaper that provides a retractable leg opening having a side flap and one or more elastic members to provide an elasticized leg cuff (gasketed cuff). U.S. Pat. Nos. 4,808,178 and 4,909,803, issued February 28, 1989 and March 20, 1990 to Aziz et al., Respectively, are " stand-up " elasticities that improve the retention of leg areas. Disclosed is a disposable diaper with a shoe flap (blocking cuff). US Pat. Nos. 4,695,278 and 4,795,454, issued to Lawson on September 22, 1987 and to Dragoo on January 3, 1989, respectively, have double cuffs comprising gasketed cuffs and blocking cuffs. Describe disposable diapers. In some embodiments, it may be desirable to treat some or all of the leg cuffs with lotions as described above.

Aspects of the present invention also provide a pocket for receiving and retaining fecal material, a spacer providing voids for the fecal material, a barrier to limit the movement of the fecal material in the product, and a comb for containing and retaining fecal material attached to the diaper. Parts or voids, and any combination thereof. Examples of pockets and spacers for use in absorbent articles are described in US Pat. No. 5,514,121, entitled “Diaper Having Expulsive Spacer,” issued May 7, 1996; US Patent No. 5,171,236, entitled Disposable Absorbent Article Having Core Spacers, issued December 15, 1992 to Drier et al .; US Patent No. 5,397,318, entitled "Absorbent Article Having A Pocket Cuff," issued March 14, 1995 to dryers; US Patent No. 5,540,671 entitled "Absorbent Article Having A Pocket Cuff With An Apex," issued July 30, 1996 to a dryer; And an international patent entitled “Spacers For Use In Hygienic Absorbent Articles And Disposable Absorbent Articles Having Such Spacer”, published December 3, 1993. Application Publication No. WO 93/25172; And US Patent No. 5,306,266 entitled "Flexible Spacers For Use In Disposable Absorbent Articles," issued April 26, 1994 to Freeland. . Examples of compartments or voids are disclosed in U.S. Patent No. 4,968,312 entitled "Disposable Fecal Compartmenting Diaper" issued to Khan on November 6, 1990; US Patent No. 4,990,147 entitled "Absorbent Article With Elastic Liner For Waste Material Isolation", issued February 5, 1991 to Freeland; U.S. Patent No. 5,62,840 entitled "Disposable Diapers" to Holt et al. On November 5, 1991; And "Trisection Topsheet For Disposable Absorbent Articles And Disposable Absorbent Articles Having Such, issued to Freeland et al., Dec. 14, 1993. Trisection Topsheet "in US Pat. No. 5,269,755. Examples of suitable cross-blocks are described in US Pat. No. 5,554,142 entitled "Absorbent Article Having Multiple Effective Height Transverse Partition," issued September 10, 1996 to Dryer et al. ; International Patent Application Publication No. WO 94/14395, entitled “Absorbent Article Having An Upstanding Transverse Partition”, published July 7, 1994 in the name of Freeland et al .; And US Pat. No. 5,653,703 entitled " Absorbent Article Having Angular Upstanding Transverse Partition ", issued August 5, 1997 to Rowe et al. All of the foregoing patent documents are incorporated herein by reference.

Aspects of the present invention may also include secretion treatment apparatus 110 as shown in FIG. 7. Secretion treatment device 110 may include a secretion bag 111 for collecting feces, urine or both. The secretion bag 111 may have a hole 121 and a flange 112 around the hole for adhesive attachment, preferably to the wearer's perianal region. In addition, the waste treatment apparatus 110 has been found to be particularly useful and beneficial when used with garments, or diapers, preferably disposable diapers. An example of a diaper 120 including a secretion bag 111 is shown in FIG. 8. The secretion bag 111 may be disposed on or coupled to any surface of the product when combined with the diaper 120 or other garment. In one embodiment, the secretion bag 111 is coupled to the topsheet 124 of the diaper 120.

The secretion bag 111 is preferably a flexible reservoir for the reception of excreted fecal matter or urine. Thus, the secretion bag 111 is preferably liquid impermeable and may still be breathable. Moreover, the secretion bag 111 is designed to have sufficient strength to withstand typical wearing conditions such as sitting.

The secretion bag 111 may include one or several layers. In one embodiment, the secretion bag 111 may comprise three layers, preferably one film and two nonwoven layers. The layers of bladder material may comprise any material, preferably a material that renders the bladder liquid impermeable. In a preferred embodiment of the present invention, the laminate may be formed from the nonwoven layer and the film.

Suitable film materials for any film layers preferably include thermoplastics. Thermoplastic materials can be vapor permeable or impermeable and include all types of hot-melt adhesives, polyolefins, in particular polyethylene, polypropylene, amorphous polyolefins, and the like; Natural fibers such as cellulose-wood pulp, cotton, jute, hemp, synthetic fibers such as glass fibers, rayon, polyesters, polyolefins, acrylics, polyamides, aramids, polytetrafluoroethylene metals, polyimides, Binders, for example bicomponent hot melt / cold melt polymers, copolymer polyesters, polyvinyl chloride, polyvinyl acetate / chloride copolymers, copolymer polyamides, materials comprising blends in which some of the constituent materials do not melt A material containing meltable components including fibers or polymeric binders; Air and vapor permeability, including microporous films such as those disclosed above for the backsheet and monolithic breathable material, such as HYTREL ^™ available from Dupont and Pebax ^™ available from ELF Atochem (France) It can be selected from materials.

Secretion bag 111 may have any shape or size. Preferred shapes include flat annular pouches, conical pouches, blunt conical pouches and pyramidal or blunt pyramid pouches and flat T shaped pouches. Moreover, the secretion bag 111 may be provided from a single piece of material, or from a number of separate pieces of material that may be the same or different and sew each periphery.

The secretion bag 111 may also contain an absorbent material. The absorbent material may include any absorbent material capable of absorbing and retaining liquids. Absorbent materials can include a wide variety of liquid-absorbent materials commonly used in disposable diapers and other absorbent articles. Some examples of these are disclosed herein in connection with the absorbent core.

The secretion bag 111 is provided with a hole 121 for receiving fecal material or urine from the body before storing it into the cavity in the bag. The hole 121 is preferably surrounded by the flange 112 and may be provided in any shape or size, for example annular, oval, heart-shaped and may be symmetrical or asymmetrical, preferably the hole Has an elliptical shape in the longitudinal or transverse direction. The flange may include protrusions designed to mate to the perineal, vulva and / or coccygeal regions of the wearer.

The flange 112 should be made of a flexible, flexible, and annealable material so that the flange 112 can easily be placed around the anus or in the genitourinary region. Typical materials include nonwovens, fabrics, thermoplastic foams in open cells, thermoplastic foams in closed cells, composites and films of open cell foams and stretched nonwovens.

The secretion bag 111 preferably further comprises coupling or attachment means for securing the device to the wearer. Such means may be any joining or attachment means disclosed herein or any other suitable joining or securing means known in the art, such as straps, belts, hook and loop fasteners, pins, ties, snaps and / or secretions. It may also include a body-compatible adhesive applied to the wearer facing portion of the pocket 111 or flange. Any skin-friendly waterproof pressure-sensitive adhesive, such as hydrocolloid adhesives and hydrogel adhesives, may be used to attach the device to the periphery of the wearer's anus or to the genitourinary region. Adhesives, which are particularly effective in providing the desired adhesive properties for anchoring the wearer's sensitive perianal region skin while being relatively painless to apply and remove, are made by crosslinking the polymer with a plasticizer to form a three-dimensional matrix.

The product 20 preferably includes one or more sensors 60 that are capable of detecting one or more health and / or nutritional markers in body secretions and having the ability to provide the detection signal to a wearer, protector or actuator. do. As used herein, the term "sensor" refers to an apparatus capable of detecting any event or a parameter associated with any event. The parameter associated with any event is any measurable signal associated with the occurrence of any event within the scope of the above-mentioned system (ie, a signal caused by a secretion, wearer or component thereof). The sensor is responsive to one or more specific inputs. The sensor can be a chemical signal, a biochemical signal, or a biological, mechanical, magnetic, thermal or other signal known in the art. The product of the present invention specifically comprises a sensor that provides a signal to the wearer, guardian or actuator that indicates the presence and / or concentration of one or more health or nutritional markers in body secretions (eg stool, urine or menses). The signal may be a chemical signal (eg, a change in pH, enzyme activity or concentration of any other chemical species) or an electrical signal, including a selection signal, ie a visible signal (eg, a color indicator or fluorescence indicator).

As used herein, “health markers” and “nutrition markers” (eg, in human stool) are any basic chemical or biological component that can be found in secretions, and the health of the wearer (eg, disease, infection, Addiction, etc.) and the relationship (eg, ratio, etc.) or any combination thereof between components having a defined relationship with each of the nutritional states. The nutritional status of the wearer may include, for example, metabolic efficiency, nutritional deficiency, malnutrition or absorption, food and beverage intake, food allergies (eg, allergy to peanuts), food intake (eg, lactose rejection), colon bacteria Ecology (such as beneficial bacteria such as Bifidobacteria and Lactobacillus) and total energy balance. Health markers include heavy metals (e.g. lead, mercury, etc.), radioactive materials (e.g. cesium, strontium, uranium, etc.), fats, enzymes, endogenous secretions, protein substances (e.g. cast), mucus, and infections, diarrhea Microorganisms (hereinafter described in more detail in the biosensor portion herein), or poisoning, which may be associated with various health problems such as gastrointestinal upset or disease. Heavy metals in certain developing countries, and in the richer regions of developed countries, older and / or older, shorter, are serious risks to health. For example, lead and mercury poisoning can occur as these heavy metals are taken from environmental sources (eg, lead paint, uncontrolled heavy industry, etc.), which can be fatal. More commonly, low levels of intoxication by these and other heavy metals exhibit delayed intellectual and / or physical development, especially in children, which can occur over time and have individual sustained effects. Protein chunks, such as (eg, in urine) casts, can be detected by tracking the Tamm-Horsfall protein. Suitable examples of sensors for tom-horse pearl proteins are described in US Pat. No. 5,780,239, which is incorporated herein by reference. Sensors suitable for heavy metals, and / or identification means useful for such sensors are described in more detail in US Pat. Nos. 5,595,635, 5,865,972, 5,814,205, and 5,468,366, which are incorporated herein by reference.

Non-limiting examples of nutritional markers 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.), Fats, fatty acids (long and short), soaps (such as calcium palmitate), amino acids, enzymes (such as lactose, amylose, lyase, trypsin, etc.), bile acids and salts thereof, steroids and carbohydrates. For example, calcium malabsorption is important because it can lead to long bone-mass deficiency. The importance of calcium absorption in adults, especially older women, has been publicized, but it is also important in children (especially infants). Infant diet may affect calcium absorption and thereby affect bone mass and / or density. For example, changing the position of palmitic acid on triglycerides, an infant formula, from the 2-position (ie, a combination such as human milk) to the 1-position and / or 3-position (such as in some infant formulas), trigly This results in cleavage of palmitic acid from the "backbone" of the ceride, which results in absorption of this nutrient from the body. Uncut palmitic acid, as a soap, binds to calcium in the digestive tract (ie calcium palmitate) and remains in body stool. (This method is described in more detail in the document "Archive of Disease in Childhood (Nov. 1997) 77 F178-F184".) Thus, calcium and / or soap content in feces is one of the tests for verifying calcium uptake by the digestive system. It is a latent means. Suitable colorimetric calcium sensors based on Arsenazo III (acidic environment) and Cresolphthalein Complexone (basic environment) are Sigma-Aldrich, St. Louis, Missouri. Chemicals) as catalog numbers 588-3 and 587-A. Examples of other sensors for calcium, and / or identification means useful for such sensors are described in US Pat. No. 5,705,620, which is incorporated herein by reference; 5,580,441 and 5,496,522.

The sensor of the present invention may be associated with a carrier structure. The carrier structure may secure, stabilize and / or at least partially encapsulate the sensor. Examples of carrier structures include one or more layers of woven and nonwoven webs, films, foams, scrims, hydrogels, and the like. The sensor may be attached to the carrier structure and secure between two or more components, layers or folds of the carrier structure, or may be sealed within the carrier material. The carrier material may optionally include an adhesive or skin adhesive composition or other attachment means to secure at least a portion of the carrier material to the skin of the product, its components or the wearer.

In certain aspects of the invention, sensor 60 may comprise a biosensor. As used herein, the term "biosensor" refers to one or more pathogenic target microorganisms or one or more biomolecules associated therewith, such as enzyme sensors, organelle sensors, tissue sensors, microbial sensors, or electrochemical sensors. It is defined as a component comprising biologically reactive means. The term "biologically reactive" is defined as having the ability to selectively interact with and preferably bind to a pathogenic target microorganism and / or its associated biomolecules. In general, biosensors function to specifically bind a biologically active target analyte and thereby provide a means for detecting the analyte. In this way, biosensors are very selective even when a mixture of multiple chemical entities and biological entities (eg feces) is provided. On the other hand, chemical sensors that rely on chemically reactive means generally do not have the high selectivity or amplification characteristics of biosensors, and are therefore biologically reactive, especially when present in low concentrations in complex media (eg, body secretions). It is not suitable for detecting analytes. Biologically targeted analytes are often components of a few complex mixtures comprising a plurality of biological and other components. Thus, in many biosensor products, it is desired to detect a target analyte at less than one million, at least one trillion or less. Thus, about 10 ⁷ to 10 ⁸ or more identification rates may be required to recognize biological target analytes in the complex mixture.

The biosensors of the invention can include bio- or element-cognitive elements to provide high specific binding or detection selectivity for specific analytes. Bio-cognitive elements or systems thereof may include biologically derived substances such as enzymes, sequences of enzymes; Antibodies; Membrane receptor proteins; DNA; Organelles, natural cell membranes or synthetic cell membranes; Viable or some viable or non-viable bacterial cells, plant cells or animal cells; Or specifically interact with plant fragments or mammalian tissue cells, and biologically targeted analytes. The bio-cognitive element is responsible for the selective recognition of physico-chemical signals and analytes that provide the basis for the output signal.

Biosensors can include bio-catalytic biosensors and bio-affinity biosensors. In a bio-catalytic biosensor embodiment, the bio-cognitive element is "bio-catalytic" and is responsible for enzymes, organelles, fragments or all cells of plant or mammalian tissue, or "turn over" selective binding sites. Which may result in significant amplification of the input signal. Such bio-catalytic sensors are generally useful for continuous detection during real time.

Bio-affinity sensors are generally applicable to bacteria, viruses and toxins and include chemoreceptor-based biosensors and / or immunological sensors (ie, immunosensors). Chemoreceptors are complex biomolecule macroassemblies that are responsible for some of the viable organisms' ability to detect chemicals with high selectivity in their atmosphere. Chemoreceptor-based biosensors include one or more natural or synthetic chemoreceptors associated with means for providing a signal (visual, electrical, etc.) of the presence or concentration of a biological target analyte. In certain embodiments, the chemoreceptor may be associated with an electrolyte (ie, an electrical converter) to provide a detectable electrical signal. Chemoreceptors may comprise all or part of a nerve bundle (eg, from an antenna or other sensing organ) and / or all or part of a natural or synthetic cell membrane. In contrast, the bio-cognitive element of an immunosensor is generally an antibody. Antibodies are highly specific and can be produced from bacteria, viruses, microbial fragments (eg, bacterial cell walls, parasite eggs or portions thereof, etc.) and large biomolecules. In any case, bio-compatible biosensors are generally irreversible because the receptor site of the biosensor is saturated when exposed to the biological target analyte.

In certain embodiments, bio-catalytic and bio-affinity biosensors can be combined, such as RNA / DNA probes or other high affinity binding systems, followed by biological amplification of the signal after the initial bio-cognitive event. For example, certain bacteria are biosensors that contain genetic material (e.g. DNA) as bio-cognitive elements, and a small number of organisms, preferably up to about 500, by PCR (ie, polymerase chain reaction) amplification. Can detect life. Bio-catalytic and bio-compatible biosensor systems are described in the literature "Journal of Chromatography, 510 (1990) 347-354" and "Kirk-Othmer Encyclopedia of Chemical Technology, 4 ^th ed. (1992). John Wiley & Sons, NY ".

Biosensors of the present invention are directed to pathogenic bacteria, parasites (e.g., any stage of the life cycle including eggs or parts thereof, cysts or mature organisms), viruses, fungi (e.g. Candida albicans), pathogens It is desirable to detect biologically active analytes, including but not limited to antibodies and / or toxins produced at microscopic levels (ie, future symptoms are likely to occur) or presently associated with human systemic diseases. In addition, the biosensors may be used to treat acute or current localized health problems (eg, stress proteins (eg, cytokines) and IL-1α (interleukin 1-alpha)) that can clinically irritate or promote inflammation of the skin. It may be a relevant biologically active target analyte. In a preferred embodiment, the biosensor functions as a proactive sensor that signals the wearer or guardian to detect an impending situation before clinical symptoms appear. This allows the wearer to have a preventable time during the symptom period, or, if not, allow time for treatment that significantly reduces its neutrality. In addition, the sensor 60 may detect the presence of biologically targeted analytes in the wearer's body secretion (eg, faeces) to detect contaminants remaining on the surface (eg, skin) in contact with the biosensor and thereby provide an appropriate signal. To provide.

The physico-chemical signals generated by the bio-cognitive element (s) may be visible to the wearer or caregiver (via a color change that may be visible to the human eye). Another aspect produces an optical signal, which may require the use of other instruments to augment the signal. These include fluorescence, bioluminescence, total internal reflection resonance, surface plasmon resonance, Raman method and other laser-based methods. Examples of surface plasmon resonance biosensors are available as IBIS I and IBIS II from XanTec Analysensystem, Muenster, Germany, which will include bio-junction surfaces as bio-cognitive elements. Can be. Alternatively, the signal may generate an electrical signal (e.g., current, potential, inductance or impedance) that is displayed (e.g., on a readout such as an LED or LCD display) or listen It may initiate a possible or detectable (eg vibration) signal, or may be processed through an associated transducer that may initiate an actuator. The signal is quantitative (eg, indicates the presence of a biological target analyte) or qualitative (ie, measures the amount or concentration of a biological target analyte). In this aspect, the transducer can optionally generate an optical, thermal or acoustic signal.

In any case, the signal is also durable (ie stable and readable over a length of multiples at least equal to the service life of the product) or transient (ie, recording real time measurements). In addition, the signal may be located at or above the product, or at other parts of the remote control indicator, including a remote device (e.g., wire or transmitter (e.g. infrared transmitter or radio frequency (rf) transmitter)). Can be sent to. In addition, the sensor 60 or any component thereof may be adapted to detect and / or signal the concentration of the biological target analyte only above a predefined threshold (eg, in this case the biological target analyte may be Usually, the concentration of the analyte is present in body secretions when present below a known "danger" level).

As mentioned above, the target analyte that the biosensor of the present invention is intended to detect may be, for example, a pathogenic microorganism associated with a disease of the gastrointestinal tract of a human, in particular a microorganism causing diarrhea. This type of pathogen is particularly important for monitoring the number of children who are seriously ill from diarrhea or die several years later. Severe chronic diarrhea has been found to reduce weight and inhibit permanent physical and mental development. A non-limiting list of pathogenic bacteria that the sensor 60 can detect includes any of various pathogenic strains of Escherichia coli (commonly known as E. Coli); Salmonella strains such as Salmonella typhi, Salmonella paratyphi, S. enteriditis, Salmonella typhimurium and Salmonella heidelberg heidelberg); Shigella strains such as Shigella sonnei, Shigella flexneri, Shigella boydii and Shigella dysenteriae; Vibrio cholerae; Mycobacterium tuberculosis; Yersinia enterocolitica; Aeromonas hydrophila; Plesiomonas shigelloides; Campylobacter strains such as Campylobacter jejuni and Campylobacter coli; Bacteroides fragilis; And Clostridia strains such as Clostridia septicum, Clostridia perfringens, Clostridia botulinum and Clostridia difficile (C difficile). A non-limiting example of a commercially available biosensor intended to detect E. coli is available as Test Kit # 4001 from AndCare Inc., Duham, North Carolina. As another non-limiting example, "bioanalytical biotransducer" available as BB Au-1050.5-FD-X from ABTECH, Scientific, Inc., Yadley, PA. Which can be biospecific (for microorganisms or other biological target analytes as described herein) by simultaneously immobilizing polypeptides, enzymes, antibodies or DNA segments on their surfaces. Other suitable microbial biosensors include US Pat. No. 5,869,272 (Gram Negative Life), which is incorporated herein by reference; 5,795,717 (Sigela); 5,830,341; 5,830,341; 5,795,453; 5,354,661; 5,354,661; No. 5,783,399; No. 5,840,488; 5,827,651; 5,827,651; 5,723,330 and 5,496,700.

The target analyte for which the biosensor of the invention is intended to be detected may also be a virus. These may include diarrhea-induced viruses (eg rotavirus) or other viruses (eg rhinoviruses and human immunodeficiency virus (HIV)). Examples of biosensors intended to detect HIV are described in US Pat. Nos. 5,830,341 and 5,795,453, referenced above. The disclosures of each of these patent documents are incorporated herein by reference.

In another embodiment, the target analyte to be detected by the biosensor of the invention may be a parasite, in particular a parasite that inhabits the gastrointestinal tract for a period of time in their life cycle. Such parasites may include parasites, worms and other gastrointestinal parasites. Other examples of parasites that can be detected include entamoeba histolytica (causing amoeba dysentery), trypana cruzi (causing Chagas disease) and plasma. Medium plasmodium falciparum.

In another embodiment, the target analyte that the biosensor of the invention is intended to detect may be a fungus such as Candia albicans. In addition to pathogenic bacteria, certain beneficial colon bacteria can be detected and / or measured as health markers, examples being Bifidobacteria and Lactobacillus strains.

The target analyte for which the biosensor of the invention is intended to be detected may also be a protein or antigen associated with a skin disease. Preferably, these analytes can be detected before or on the surface of the skin, preferably before clinically observable skin irritation. These include other immune response factors, including interleukins (eg, IL-1α, IL-2, IL-3, IL-4, and IL-8), stress proteins such as cytokines and histamine, and interferons (interphenols a and g). Inclusive). It is also desirable that they can be detected by the sensor 60 before clinically observable erythema, irritation or skin disease is initiated. In addition, the biosensors of the present invention can be adapted to detect enzymes or other biological factors associated with skin irritation (eg diaper dermatitis) such as trypsin (trypsin), chymotrypsin and lipases.

The biosensors of the present invention may also include bio-recognition systems comprising binding proteins or enzymes, such as antibodies immobilized on the surface of a physico-chemical transducer. For example, certain strains of bacteria can be detected through biosensors using antibodies generated against the bacterial strains. Alternatively, the target bacteria can be detected by bio-cognitive elements (eg, antibodies, and synthetic or natural molecular receptors) specific for the toxin produced by the extracellular product of the target bacteria, such as a strain (eg, E. coli). have. An example of an enzyme electrode that can be used to detect phenol (eg, present in urine or feces) is described by Joseph Wang et al. On October 14, 1997 as "Remote Electrochemical Sensor." U.S. Patent No. 5,676,820 to U.S. Patent No. 5,676,820, and Feb. 25, 1992, to PF Turner et al., Entitled "An Enzyme Electrode For Use In Organic Solvents." Tyrosinase-based electrodes or polyphenol oxidase enzymes described in patent 5,091,299, respectively. All of these patent documents are incorporated herein by reference.

In any preceding example, a particular microorganism may be detected directly or by binding to toxins, enzymes, or other proteins produced by an organism or antibody, such as antibodies of a single cell population specific for that organism. Examples of biosensors intended to detect proteolytic enzymes are described in US Pat. No. 5,607,567 and examples of biosensors intended to detect toxins are described in US Pat. Nos. 5,496,452, 5,521,101, and 5,567,301.

Any sensor 60 of the present invention may include one or more "proactive sensors" 60. This is particularly useful in embodiments in which detection of biologically reactive target analytes, health and / or nutritional markers initiates clinically observable health symptoms. As used herein, the term “proactive sensor” refers to a wearer's body (ie, skin) that is directly related to, or at least correlated with, the occurrence of an impending or potential health related or skin related event. Refers to a sensor capable of detecting a change or signal to, or a change or signal (ie, an input) in the secretion. The proactive sensor can respond to one or more specific inputs as described above.

Detecting an urgent event, in particular a parameter that is directly related to, or at least correlated with, the occurrence of a systemic or skin health event or disease, can be detected. Imminent events that can be detected or predicted by the proactive sensor 60 of the present invention include early lead poisoning, or malnutrition, diarrhea, skin irritation or rashes (eg, candidiasis). Other types of diseases or medical conditions, such as malnutrition and / or vitamin deficiency, and / or parasite infections in the wearer. The detected health, nutritional markers and / or biological analytes may be removed one or more steps from the actual presentation of clinical symptoms. For example, sensors can detect potential precursors to such conditions (eg, fecal contamination of the skin that can cause stress proteins and cause clinically observable skin irritation). The parameter associated with the event is a signal such as any measurable input associated with the occurrence of the event within the reference frame of the system, ie one or more of the potential inputs listed above. Proactive sensor 60 in the product may measure a number of different inputs to predict an event. For example, proactive sensor 60 may monitor (ie, detect residual contamination) Candida albicans in the feces and residual colon bacteria on the skin, each of which is a signal that can advance skin irritation. ).

In a biosensor embodiment in which the bio-cognitive element does not produce an easily visible signal (eg, color change), the sensor 60 includes a transducer in communication with the bio-cognitive element to convert the physical-chemical signal into the bio-cognitive element. Can be converted into a signal available to the wearer, protector or component of the product (eg also an actuator). Examples of transducers include electrochemical transducers known in the art (eg potentiometric transducers, amperometric transducers and conductive transducers), optical transducers (eg fluorescence, bioluminescence, total internal reflection resonances). And surface plasmon resonance), thermal transducers, and acoustic transducers. A power source, such as a miniature three volt watch battery or a printed thin film lithium battery, can be connected to the sensor 60 to provide any necessary power.

The efficiency of the biosensor of the invention can be measured by the response factor test described in the test method section below. The response factor describes the ratio of the biosensor's response when exposed to fecal test substance compared to the biosensor's response when exposed to physiological saline, which is found in the feces compared to urine. It is useful for verifying the sensitivity of the biosensor to biologically active analytes that are expected to be. The biosensor of the present invention is preferably at least 2, 3 or 5, more preferably at least 10, even more preferably when fecal test substance is exposed in test urine or aqueous solution having 1 g of fecal test substance per gram of physiological saline. Has a response factor of 20 or greater. (Physiological saline is used herein to indicate background input signals present in most natural environments, such as aqueous fluids.) These biosensors are used to present fecal matter and physiology for biologically active target analytes specific to feces. It is clearly distinguishable between the presence of brine.

The method of detecting feces is to detect skatole, a substance commonly found in fecal matter. Scatol concentration in stool was found to be about 180 μg per gram of stool material, while scatol concentration in urine was found to be substantially low. Scatol is generally the product of microbiological degradation resulting from catabolism of tryptophan in the digestive system.

In a preferred embodiment of the skatole detection biosensor, the biosensor comprises a genetically engineered microorganism that assimilates scatol and / or other substances. Assimilation of a skatole specific substance can be measured, for example, via oxygen consumption during the assimilation action. Suitable microorganisms for detecting skatole are Acinetobacter baumannii TOI36 (FERM P-12891, JP05304947), and Bacillus sp. TOI41 (FREM P-12914, JP05304948). It includes. Suitable biosensors comprising such microorganisms are available, for example, under the name Mikrobielle Sensoren from Institut fur Chemo- und Biosensorik, Münster, Germany.

If the microorganism is incorporated into the biosensor, the microorganism may be immobilized in the biosensor by methods known in the art such as capture, adsorption, crosslinking, encapsulation, covalent attachment, combinations thereof, and the like. In addition, the immobilization can be performed on a number of different substrates as known in the art. In certain preferred embodiments, the fixative substrate may be selected from the group consisting of polymeric materials, hydrogels, tissues, nonwoven materials, woven materials.

In certain aspects, the sensor 60 comprising any biosensor aspect is disposed on a microchip, such as a silicon chip, a MEM (ie, a micro electromechanical system) device or an integrated circuit, or the microchip And operatively connected with the. Microchip-based biosensors may be known as "biochips." Regardless of the type of sensor, the microchip can have multiple, with similar or different sensitivity, power, and / or target analytes (ie, markers) in an alignment that is intended to detect different levels or combinations of target analyte (s). It may include a sensor component of. In addition, each of the sensors in such an arrangement may provide different types of signals, including the types disclosed herein, and may be associated with different actuators and / or controllers. In addition, each sensor in the alignment may operate independently or in connection with (eg, in parallel, in combination with or in series with) any number of other sensors in the alignment.

Any sensor 60 of the present invention may be disposed or operatively connected to any portion of the disposable product that is exposed to an input designed for the sensor to detect. For the purposes of the present invention, the term " operably connected " refers to a communication means that causes sensor 60 to send out a portion of product 20 when detecting an input. The sensor 60 may be separated from and operatively connected to another portion of the sensor 60, another sensor 60, an actuator, a controller, or some other portion or component of the product 20. "Operably connected" may include communication means (eg electrical connection) via transmitted signals, such as radio frequency, ultraviolet or other transmitted frequency communications, for example via conductive wires or members. Alternatively, sensor 60 may be operatively connected via a mechanical connection, such as an air or hydraulic connection.

In a disposable product aspect (eg, diaper 20 of FIG. 1), sensor 60 may be located in the front waist region 36, rear waist region 38, or crotch region 37 of the article, Body portion 22, top sheet 24, back sheet 26, absorbent core 28, side panel 30, leg cuff 32, waist feature 34, fastening system 40, It may be integral with, positioned adjacent to, coupled to, or including a portion, such as longitudinal edge 50 or end edge 52. In any preferred embodiment in which the biological target analyte is associated with body secretions, the sensor 60 may be placed in the crotch region of the product 20 to maximize the likelihood that the body secretion will contact the sensor 60. In another preferred embodiment in which the sensor is adjusted to detect or measure a biologically targeted agent of the wearer's skin, the sensor 60 is a topsheet, cuff, waist feature, stool receiving bag, spacer, or any of the products in contact with the wearer's skin during use. Can be placed in other parts of the. In any aspect, the sensor may also be associated with a lotion or other skin care composition in the product.

Sensor 60 may be integral with product 20 or may be installed by a protector or wearer. The sensor during the wearing process of the product may also be at least partially detached from the product and attached to the wearer's skin. The sensor may be permanently or detachably secured to a support structure including adhesive tapes, cellulosic or synthetic webs, nonwoven highlofts, films, scrims, foams, etc. (e.g. Velcro, registered Through a mechanical fastening system or a water-soluble adhesive). Moreover, sensor 60 may be completely contained within a product, such as product 20, or may have a receptacle located within the product such that it contacts a desired input and other portions, such as transmissions located within or outside the product. have. Sensor 60 is operatively connected to a portion of product 20 such that sensor 60 can detect an input external to product 20 and provide a signal to a controller and / or actuator. Can be on the outside. In some embodiments, the sensor may be separated from the product, and may be applied separately to some portions of the wearer, for example, via an adhesive or other means as is known in the art, and / or may be applied to one or more components separated from the product. Can have

In some aspects, the wiping means or element allows the wearer or guardian to sufficiently clean the body secretion from the sensor 60 to allow visual assessment or reading of the signal (especially for sensor aspects that provide such a signal). Can be provided. The wiping element is a web (cellulosic or synthetic), nonwoven high loft, film, foam, rigid or semi-rigid squeegee like element positioned on the product and adapted to be used to clean the sensor display. And the like. The wiping element may be at least partially secured to a component of the product, such as the topsheet, in proximity to the sensor 60 by means known in the art. The wiping element may optionally include water or any other known cleaning aid to facilitate cleaning of the wearer or sensor display.

In any preferred embodiment, the article 20 may also include an actuator. As used herein, the term "actuator" refers to an apparatus that includes "potential" and means for converting the potential to perform or activate a "response function." The potential of the actuator may include stored energy, potential energy or stored material. Thus, the actuator can transform the potential energy into kinetic energy or release or transfer the stored material to perform or activate the response function. “Responsive function” is defined for the purposes of the present invention as a signal to the wearer or guardian or function performed on a body secretion, wearer, product or component or ingredients thereof. Components of the body secretion may include moisture, electrolytes, enzymes, volatile gases, bacteria, blood, and the like. The wearer's components may also include skin, genitals, anus, anal sphincter, and the like. The components of the product may also include leg cuffs, waist cuffs or other secretion blockers and / or containing components, side panels, ear shaped members, body parts, absorbent cores, capture components, fastening systems, longitudinal or end edges, and the like. Can be. Potential energy can be stored as mechanical, electrical, chemical or thermal energy. As used herein, “kinetic energy” refers to a dose that does work or performs a responsive function as described above (eg, expansion of a compressed device, rotation of a twisted device, gel moving when the phase changes, skin Or coating or treating feces, inhibiting enzymes, adjusting pH, etc.).

The creation of three-dimensional structures for capturing secretions involves, for example, the components of the product and ultimately the response function performed on the secretions. Capture of secretions, wiping of the wearer's skin or treatment of the skin with a skin protective composition, antimicrobial, antifungal or enzyme inhibitor is a response function performed for example on secretions and / or the wearer. Adjustment of product geometry (one, two or three dimensions) or physical properties (eg, bending modulus, geometry, etc.) is an example of a response function, which can be performed in a product. Sending what happens or is about to happen to the guardian and / or wearer is also considered a response function for the purposes of the present invention. The signal can be visible, audible, touchable, electrical, chemical or biological. Actuators of disposable products may, for example, release or deliver deodorants, enzyme inhibitors, antibacterial agents, antifungal agents, skin protective compositions or pH adjusting agents; To capture, wipe, cover, hold, immobilize, seal, pump or store body secretions; It may release or produce a structure or element designed to perform one or more of these functions or any other responsive function on a secretion, wearer, product, or component thereof.

The actuator of the present invention may release potential energy to perform or activate a responsive function on a secretion, wearer, product or component thereof. The release of potential energy may convert mechanical, electrical, chemical or thermal potential energy into mechanical, electrical or chemical kinetic energy to perform a response function. The actuator may be actuated by an input of a threshold to release potential energy to perform a response function or may continuously respond to the input as described below. For example, the compressed foam can store compressible mechanical potential energy and provide mechanical kinetic energy when released. Twisted foam stores mechanical kinetic energy, ie torsional mechanical potential energy, which can provide rotation upon release. In addition, stored chemical, electrical or thermal energy can be used to release electrical, mechanical, chemical or thermal kinetic energy. Actuators of disposable products may include, for example, one or more of the following: stored lotions, antifungal or antibacterial agents, fecal modifiers, enzyme inhibitors, pH buffers, dyes, pressurized gases, compressed foams, twisted foams, pumps, closed systems Absence of liquid delivery, electrosensitive gels, pH sensitive gels, salt concentration gels and the like. Potential energy can be stored in a manner sufficient to maintain or inhibit it until required. Suitable means for maintaining and / or inhibiting such energy include, but are not limited to, batteries and / or capacitors, elastic twisted stretched materials or structures in the form of unreacted reagents, and materials capable of performing physical or chemical functions (eg, Absorbents, emollients, pH buffers, enzyme inhibitors, stool modifiers, compressed gases, and the like).

Alternatively, the actuator of the present invention may comprise a large amount of stored material having a capacity to perform or activate a responsive function on a secretion, wearer, product or any component or components thereof. In one aspect, for example, the actuator may release or deliver stored material that performs a response function. In this aspect, the actuator can be actuated by input of a threshold for discontinuously releasing or delivering the stored material at a given time or can continuously release or deliver the material. Actuators can include, for example, stored lotions, skin care compositions, antifungal or antibacterial agents, fecal modifiers, enzyme inhibitors, pH buffers, dyes, and the like. In any preferred embodiment, the material may be delivered by an actuator, such as an expandable elastic material, released high pressure gas, or the like.

2 and 2A illustrate an actuator 90 that includes a compressive elastic material 94 (eg, foam) sealed under at least partial vacuum in a pressure differentiation device 91. As used herein, the pressure differentiation device is any device or structure capable of keeping the elastic material in a compressed state (eg, by providing a defined pressure on the compressive elastic material 94 to store energy). "Compressed state" is defined as the condition where the material is held in a smaller volume than the material has when it is not limited and under an applied pressure of zero. For elastic materials, the compressed state can generally be achieved by applying pressure to the surface of the material or through any other means known in the art. The pressure differentiation device may comprise, for example, an elastic or inelastic band or strand that defines the elastic material, or a vacuum sealed bag or stretch material such as a strand, strip, film, nonwoven, scrim or foam. Preferably, the compression of the elastic material held by the pressure differentiation device 91 may be at least partially reduced through the trigger mechanism (ie, the compressive elastic material 94 may be at least partially inflated). ). The trigger mechanism is any element or device, such as a sensor, actuator or combination thereof, that responds to an input for performing pressure equalization in the pressure differentiation device 91 and causes the compressive elastic material 94 to at least partially expand. Upon release of the compressed material, for example, when a biologically active target analyte is detected, the compressive elastic material may expand and deliver the stored material. In some embodiments, it may be advantageous for the actuator to include void space 96.

The elastic material may include any elastic material and is available from Foamex Corporation, Edison, Penn., Identified as SIF / 210PP1 or Aquazone 80A foam, MC1900EVA 2 lb / ft ² available from Sentinel Products Corporation of Hyannis, Mass., Or "Absorbent foam materials for aqueous body fluids, issued to Desmarais et al. On November 9, 1993. US Patent No. 5,260,345 entitled "Absorbent Foam Materials For Aqueous Body Fluids and Absorbent Articles Containing Such Materials";"Thin-Until-Wet Absorbent Foam Materials For Aqueous Body Fluids And Process For Making Same," by Dyer et al., Dated February 7, 1995. US Patent No. 5,387,207 entitled "); And Absorbent Foam Materials For Aqueous Fluids Made From high Internal Phase, issued to Desmaraes et al. On July 22, 1997, having a very high water-to-oil ratio. Emulsions Having Very High Water-To-Oil Ratios) include, but are not limited to, HIPE foams described in US Pat. No. 5,625,222 (the above identified patents are each incorporated herein by reference).

In some aspects of the invention, the pressure differentiation device 91 may comprise a soluble bag. Soluble bladder may be soluble in the presence of one or more different types of input such as water, urine, fecal enzymes, pH levels, etc., and may be designed to set the threshold of input required to dissolve the bladder. Will have properties (eg, thickness). Soluble pouches are for example monosol M7031, M7030, M8630, M8534 or E6030 films by Chris-Craft Industrial Products, South Holland, Illinois or as HL1636 or HL1669-X. Water soluble plastic films, such as PVA films supplied by HB Fuller Company, St. Paul, Minn. Film thickness can also be modified, for example, to provide the desired activation. The film used may also have a thickness of, for example, about 0.00005 to about 0.0015 in. HL1636 films with a thickness of about 0.001 in will be activated with a moisture content of, for example, about 0.049 g / in ² .

The actuator may alternatively comprise an electrically sensitive gel. An electrically sensitive gel is a polymeric gel network that changes volume and / or geometry under the application of an electric current or electric field when at least partially swelled with water. For example, any partially ionized polyacrylamide gel will cause an anisotropic shrinkage of about 50% under a weak electric field (eg 0.5 V / cm) when immersed in acetone and water. Other electrically sensitive gels can cause electrically induced warpage in the presence of water and surfactants or exhibit alternating wave motion when placed in an alternating electric field. It is contemplated that local shrinkage can be induced on a portion of the gel, for example on one side of the gel element, by concentrating the positively charged surfactant molecules on the negatively charged gel polymer in the electric field. Changing the strength and / or polarity of the field induces motion in the gel as one side decreases in length (eg, the gel formed in the strip may be twisted). Electrically sensitive gels provide rectangular, circular, reticulated lattice to provide a valve for releasing material as it changes volume and / or geometry, to flow body secretions, to prevent body secretions, to encapsulate body secretions, etc. It may include various geometries such as patterns such as shapes. The electrically sensitive gels formed in the strips may be bent to provide usable void space when electrical activity is detected, for example, in the external anal sphincter in advance of bowel movements or urination.

In Figures 5A and 5B, for example, a strip of electrosensitive gel 494 is shown in a circuit where fecal moisture bridges contact 485 and allows current to flow through the electrosensitive gel to flex or unfold the strip. Alternatively, the electrically sensitive gel 594 formed in the reticulated lattice pattern 595 shown, for example, in FIGS. 6A, 6B, and 6C may detect urgent urination to allow urine to flow to other parts of the product 20, or It can be electrically induced to swell or shrink to form a valve that prevents flow. For example, FIG. 6A shows a circuit comprising a reticulated lattice pattern of an electrically sensitive gel. 6B and 6C also show lattice micrographs of constricted and swollen outlines, respectively. An example of a material is a lightly crosslinked PAMP gel (poly (acrylamido-2-methylpropane) sulfonic acid). This type of gel can perform several functions, such as applying or delivering chemical stool treatment agents. Examples of other electrically sensitive gels are described in US Pat. No. 5,100,933 and International Patent Publication No. WO9202005, issued to Tanaka on March 31, 1990, both of which are incorporated herein by reference. Alternatively, pH sensitive gels or salt concentration sensitive gels, each varying in volume and / or geometry at a particular pH or salt concentration, may be used as the actuator of the present invention, respectively.

The actuator may be disposed and / or operatively connected to any part of the disposable product that causes the actuator to respond to body secretions, the wearer, the product, or components thereof. In the article 20, the actuator can be located, for example, in the front waist region 36, the rear waist region 38 or the crotch region 37 of the article 20, the body 22, the top sheet ( 24, back sheet 26, absorbent core 28, side panel 30, leg cuff 32, waist feature 34, fastening system 40, longitudinal edge 50 or end edge (52) and the like, may be integrally or adjacent to one another or combined. The actuator may also be completely contained within the product, such as product 20, or may have a portion located within the product and a portion located external to the product 20, or may be completely external to the product 20. The actuator or part of the actuator may be operatively connected to one or more sensors 60, one or more controllers 80, other portions of the actuator, or other portions of the product 20. Moreover, the actuator may be integral with the product 20 or may be installed by a protector or wearer.

The product 20 may also include a controller. A “controller” is defined for the purposes of this application as a device that receives input from a sensor and determines that one or more actions are taken. The controller may receive a signal from the sensor 60 and cause the actuator to respond to body secretions, wearers, products or components thereof. Alternatively, the actuator may receive a signal directly from sensor 60 and perform a response function to the wearer, secretion, product or component thereof. The controller may comprise a substance that undergoes chemical or physical changes and may be a chemical, mechanical or electrical device that processes information from sensors or the like. Biosensor 60 may include a transducer that includes a multilayer Langmuir-Blodgett film, at least some of which may act as controllers, where one or more layers include a bio-cognitive element. . Upon contact with water, it is known that the Langmore-Brazette film simultaneously reorganizes to produce regions with more layers and other regions with fewer layers than the original layer. This reorganization may preferentially expose bio-cognitive elements to the environment in the presence of water, such as body secretions, which may contain biologically targeted analytes. This may reduce the wrong amount of factors and / or extend the life of the biosensor. Alternatively, an electrical controller that receives a signal, such as an electrical potential, from an electrochemical sensor may receive or monitor multiple electrical signals and repeatedly activate the actuator. The controller may be integral with the sensor component or with the separate component of the actuator component or the system.

The controller may be disposed and / or operatively connected to any part of the disposable product such that the controller receives a signal from the sensor 60 and provides a signal to the actuator. In the article 20, for example, the controller may be located in the front waist region 36, the back waist region 38 or the crotch region 37 of the article 20, and the body 22 or the top sheet ( 24, back sheet 26, absorbent core 28, side panel 30, leg cuff 32, waist feature 34, fastening system 40, longitudinal edge 50 or end edge (52) and the like, may be integrally or adjacent to or disposed of. The controller may be integral with the product 20 or installed by a protector or wearer. The controller may be completely contained within the product, such as product 20, or may have a portion located on the product and a portion located external to the product, or may be located completely outside the product 20. The controller or part of the controller may be operatively connected to one or more sensors 60, one or more actuators 90, other portions of the controller, or other portions of the product 20. The controller may receive a signal from the sensor 60 and provide a signal to the actuator, for example by radio frequency (rf) transmission.

Although separate structural elements may perform the sensor 60, actuator and controller functions, the sensor 60, actuator and / or controller functions of the present invention need not be performed by the separate structural elements. The sensor 60 and controller functions can be performed by the same structural element, for example.

A “response system” is defined for the purposes of this application as a system that includes an actuator and a sensor 60 that act on a body secretion, a wearer, a product, or a component or components thereof when the sensor 60 detects a suitable actuation input. . Upon sensing a given input parameter, the actuator performs the release of stored energy or the release or transfer of stored material to perform a response function. For example, when the pre-operational sensor 60 including the transducer detects an impending situation, the transducer provides a signal for the actuator to perform the release of stored energy. By detecting an input signal prior to an emergency case, the response system in the product can be activated in case of such an emergency or for calling to a guardian or wearer in case of an emergency. This is an opportunity in which secretion management or treatment techniques are initially "cloaked" or prohibited, but are available at or immediately before the need and / or the product is available to the caregiver or wearer in advance (in case of detected pathogenic microorganisms or residual fecal contaminants). Configure the product to provide the wearer with preventive treatment). Regardless of the specific input, in these aspects the sensor 60 may operate the actuator to act on the product, the wearer or the environment in order to provide the guardian with a signal in case of occurrence or of an impending occurrence. If the sensor 60 includes a sensing system, one actuator can be actuated by another sensor and / or signal, or the other actuator can be actuated by another sensor and / or signal. Alternatively, one sensor and / or signal can operate multiple actuators.

The response system may respond in a "continuous" or "discontinuous" manner. As used herein, a "continuous response system" means that the output is quantitatively dependent on the amount of input, i.e. the continuous increase in the amount of input is required to continuously increase the amount of output or the passive of the material in which the output of the response system is stored. Refers to a response system comprising release. Superabsorbent polymers located in the absorbent core of a product may, for example, depend on the amount of input of the output, i.e. when an increase in liquid secretion comes into contact with the superabsorbent polymer, To provide a continuous response. Stoichiometric chemical reactions are another example of a system that has a continuous response to an increase in output. In reaction A + excess B → C, for example, the amount of excess B converted to C is stoichiometric, and thus refers to the amount of A that is available “continuously” in the system.

However, the "discontinuous response system" of the present invention refers to a response system having an output function that is essentially independent of the amount of input beyond the threshold. For example, when a given input of one or more thresholds is satisfied, the response system releases all or a predetermined portion of its stored energy or transfers all or a predetermined portion of its stored material, i.e., is active, to perform a particular response function. Can be sent to In an ideal aspect of the invention, the output function f (x) comprises the "step" function shown in FIG. 3A. In this aspect, the rate of change of the output (d (output) / d (input)), i.e., the slope of the output function f (x) or first derivative f '(x), with the input increase level is preferably Essentially zero if above or below the threshold. However, at the threshold, the rate of change d (output) / d (input) is preferably directed to infinity. Thus, in an ideal discontinuous response, the limit of a function f (x−ε) at ε → 0 is not equal to the limit of a function f (x + ε) at ε → 0, that is, :

However, the present invention recognizes that ideal instantaneous step changes in thresholds are not practical and may not be possible in many cases. In a preferred aspect, it is only necessary for the output function to actually have a step change with very little change with little change at or around the threshold of the input. Thus, the present invention contemplates the discrete response system of the present invention having an output function that responds in a sufficiently discontinuous manner in the transition region such that the output function has a minimum relative gradient in the transition region or more. In a preferred method of determining whether a given output function is performed in a sufficiently discontinuous manner as defined for the purposes of the present invention, without wishing to be limited to any particular way of describing or modeling a discontinuous system, The slope is compared with the relative slope of the line between the first point and the final point of the transition area. For example, FIG. 4A illustrates an exemplary output function f with an ordered graph of the first derivative f '(x), second derivative f "(x) and third derivative f'" (x) of the exemplary output function. The graph of (x) is shown. The output function f (x) describes the effect of the input (x or I) on the output or response (R (I)). For the purposes of the present invention, the transition region is defined as the region between the relative maximum value R (I ₁ ) and the relative minimum value R (I ₂ ) of the second derivative f ″ (x) of the output function f (x). The maximum value R (I ₁ ) and the relative minimum value R (I ₂ ) are the points at which the third derivative f '"(x) is zero. The inflection point I ₀ is defined as a point in the transition region in which the second derivative f " (x) is zero, i.

The comparison of the slope of the output function at the inflection point and the slope of the line between the first point and the final point of the transition region can be described by the following equation:

Where dR / dI at the inflection point is the first derivative of the output function at this point. ΔI _T is the change in input to the response system between the first point I ₁ and the end point I ₂ of the transition region, i.e. (I ₂ -I ₁ ), and ΔR _T is between the first point and the end point in the transition region. Is the change in the response of the output function, ie (R (I ₂ ) -R (I ₁ )). The coefficient k is a proportional constant describing the relative slope of the slope of the output function at the inflection point I ₀ compared to the slope between the first point and the final point of the transition region. In order for the response system to have a discrete output function, the proportional constant k must be at least about 2.0, preferably at least about 3.0, more preferably at least about 5.0, even more preferably at least about 10.0, and at least about 100.0 is most preferred. .

In any aspect, the relative slope in the transition region of the discontinuous response system can also be modeled by the transfer function of the control system having a series of integer (n) primary parallaxes with the same time constant. The transfer function of the response system is defined for the purposes of the present invention as the ratio of the Laplace transform of the output (response variable) to the input (fluctuation variable). See, for example, Robert H. Perry & Don Green, Perry's Chemical Engineer's Handbook, Sixth Ed., Chap. 22 (McGraw Hill, Inc. 1984). As shown in FIG. 4B, the relative slope of the output function is represented by the equation KG (s) = K / (Ts + 1) ⁿ where KG (s) is the transfer function, K is the proportional element, and T is the system N is an integer of the primary time difference). In this model, as the number n increases, the slope of the output function in the transition region increases and the model begins to approach a discrete response system. Certain discontinuous response systems of the present invention can be modeled by the above equations when n is about 25 or more, more preferably n is about 50 or more, and most preferably n or about 100 or more.

As shown in FIG. 3A, the response system of the present invention may include a single threshold at which the response system may release all of its stored energy to perform a particular response function or the system may have one at each threshold. It may include multiple thresholds capable of releasing a predetermined portion of its stored energy to perform the above specific response function. In an aspect with a single threshold, for example, the response system may release all of its stored energy to perform the overall response function when the threshold is met. In this single threshold aspect, in this example, the discrete response system includes a system having two states, such as on or off. When a critical amount of input, such as a biological target material, is present in the absorbent product, the response system may perform a single response function on the secretion, wearer, product or components thereof, for example to cover the secretion away from the user's skin or It provides the guardian with a visible signal that can be easily detected. Thus, the discrete response system may perform a one-time “switch-like” function that changes from one state to another in the presence of a threshold input.

Alternatively, as shown in FIG. 3B, the response system may generate multiple thresholds at which each system may release a given amount of energy or deliver a given amount of material to perform a particular response function when each threshold is met. Can have In this aspect, when each threshold is satisfied, part of the overall response function may be performed and / or other independent response function may be performed in response to the other threshold being satisfied. For example, the response system can monitor fecal enzymes and deliver the same or unequal amounts of enzyme inhibitor (s) or lotions when each critical enzyme level is met, or with a pH buffer at a first threshold. Other response functions, such as delivering large amounts of enzyme inhibitor (s) to a second threshold. In each transition region, the response system responds essentially the same as the transition region in the single critical aspect described above.

In addition, the response system monitors multiple inputs, such as one or more pathogenic bacteria and / or one or more fecal enzymes, and performs only one or more response functions when the other inputs of the threshold are satisfied or only when the other inputs of the two or more thresholds are satisfied. One response function can be performed. Thus, the controller can monitor multiple different inputs and perform different response functions when different inputs of thresholds are satisfied. Alternatively, the controller may perform a logical OR-gate type function such that the response function may be performed when multiple inputs of one or more thresholds are satisfied. The controller may also perform a logical AND-gate type function such that the response function may be performed when two or more different inputs of each threshold are satisfied.

The response system may also include a "closed loop" or "open loop" system. The “closed loop”, also referred to as the “feedback control loop”, includes the isolation sensor 60 and the actuator component and performs a response function to the input. In some preferred aspects, the system can also use the measurement or detection of a parameter or element of an output condition as a trigger of one or more response functions performed on an input. The output condition may be the state of the input condition after the actuator has the opportunity to perform a response function on the input condition. The response function may be performed when the output condition reaches a threshold or may only be performed when the output condition and one or more other conditions are met. Actions on the input may include actions on the sensed element, for example, sensing a microbe and acting on the microbe, or actions on a composition in which the sensed element is an integral component, eg, fecal bacteria and Action on the remaining stool or stool mass of the skin. As described above, the feedback control loop system includes two or more separate components: a sensor 60 and an actuator. Sensor 60 detects a case or a parameter associated with that case. The actuator receives a signal and performs a function of responding to the input condition detected by the sensor 60. The feedback control loop may further comprise a controller. In this case, sensor 60 may provide a signal to the controller, which may cause the actuator to perform a function of responding to an input condition. The controller may be a separate component of the response system or the controller function may be performed by the sensor 60 and / or the actuator.

The feedback control loop can be "unregulated" or "regulated". In a "unregulated" feedback control loop response system, the response system acts as a one-time switch where the actuator performs a response input to the input when the threshold output condition is met. For example, sensor 60 may detect or measure the presence of concentrations of certain pathogenic microorganisms, and the actuator may inform the guardian of a potential early infection. In this example, the actuator acts on the input detected by sensor 60. However, the "regulating" feedback control loop includes a sensor 60, an actuator and a controller. In a regulated feedback control loop, the output conditions are monitored constantly or repeatedly, and the controller allows the operator to perform a response function to the input to maintain the output at a desired set point or within a desired range, or at a level or concentration of a biological target analyte. To provide a continuous measurement of.

However, an "open loop" system is a system that responds to input to perform a response function without using feedback, i.e., has no effect on the sensed input entering the system. The open loop system may include a response system with a single device that performs the functions of both sensor 60 and the actuator or may have an actuator component and a separate sensor 60 in which the actuator acts on something other than an input. For example, superabsorbent polymers located in the absorbent core of disposable absorbent articles provide an open loop response because the polymer comprises only a single device that performs the functions of the sensor 60 and the actuator. Alternatively, the open loop response system may include a sensor 60 that detects body secretions or components thereof, and an actuator that performs a response function in a continuous or discontinuous manner to something other than an input detected by the sensor 60. Can be.

Other response systems are described in US Patent Application Serial No. 09 / 106,424, entitled "Disposable Article Having A Discontinuous Responsive System," filed June 29, 1998, each of which is incorporated herein by reference. Arc (P & G case number 7197); US Patent Application No. 09 / 107,563 (P & G Case, entitled Disposable Article Having A Responsive System Including A Feedback Control Loop, filed June 29, 1998). Number 7198); And US Patent Application Serial No. 09 / 106,225 (P & G Case Number, entitled Disposable Article Having A Responsive System Including A Mechanical Actuator), filed June 29, 1998. 7199).

An example of a diaper 20 of the present invention may include a response system that includes the sensor 60 shown in FIG. 1 and the actuator shown in FIG. 2. In this aspect, the sensor 60 may comprise a transducer operatively connected with a bio-cognitive element adapted to detect E. coli in the stool. Upon specific detection of the Escherichia coli at the threshold by the bio-cognitive element, the transducer uses a current to signal the actuator. The article shown in FIG. 1 may include an actuator comprising a compressive elastic material 94 vacuum sealed under a water soluble film 91 (eg, a PVA film) as shown in FIG. 2. Upon receiving the appropriate signal from the sensor, the actuator may close the switch and release a small amount of stored water, for example to contact and dissolve the water soluble film 91. This causes the release of stored mechanical energy from the compressed foam. Elastic material 94 expands to form spacers to provide void volume for initial feces. Alternatively, the switch closure may further release an antimicrobial agent to inhibit E. coli and / or release a visible dye to inform the wearer or protector of the presence of E. coli. In another aspect, the response system can include an actuator informing the guardian or wearer of an urgent case, such as diarrhea infection or skin irritation (eg, candidiasis).

In another aspect, the invention can include a partial body cover, such as a hand cover, that can detect and inform a particular biological condition to a user. The hand cover can partially or wholly protect the hand or any other part of the body. Preferably, the sensor is generally located at or near at least a portion of the outer surface. Examples of hand cover forms include, but are not limited to, finger covers, gloves, mittens, and hand wraps. Preferably, this body cover is disposable. Such covers can be used for medical care and assessment, veterinary and veterinary care and assessment, agricultural work related to plant or livestock products, and for the manufacture and handling of commercial or household food for the intended consumption by humans or other organisms.

In another aspect, the present invention may include a product for food handling, storage or manufacture used in connection with food for the intended consumption by humans or other organisms capable of detecting and informing a user about a particular biological condition. Preferably, such products are disposable. Preferably, the sensor is generally located at or near the portion of the surface that is in contact with or in contact with the food. The product can be used in the handling of raw foods in various stages of handling or manufacturing or in combination with the whole manufactured food. Such products include hard or flexible food preparation mate, covers and sheets; Food storage materials such as rigid containers, rigid containers or linings for surfaces, food wrappers which are preferably made of a flexible material; And food serving products such as rigid or flexible trays, plates, platters, bowls, food wrappers and sheets that act in the same manner as replacement plates.

Test Methods

Response factor test:

In the response factor tests described hereinafter, the response of a quantitative sensor can be measured as a response to exposure to a particular substance or composition.

Specific materials or compositions for which this test is suitable include:

Stool test substance in an aqueous solution having a concentration of 1 g of stool test substance per gram of physiological saline solution;

Fecal test substance in test urine solution having a concentration of 1 g of fecal material per gram of test urine solution;

Test urine solution;

Solution of skatole in physiological saline solution with a concentration of 180 micrograms of skatole per gram of physiological saline solution; And

Physiological saline solution.

All measurements were performed at body temperature (37 ° C.). The method includes the following steps in the following order:

1) Record the quantitative response of the sensor after exposure to physiological saline solution for 24 hours. The background response is the best recorded response.

2) Expose the sensor to a specific material or composition.

3) Record the sensor's quantitative response while the sensor is still exposed to a specific substance or composition for 24 hours. The material response is the best recorded response.

The response factor is obtained by standardizing the material response as the background response. If the response factor is less than 1, the mutual value of the response factors is reported as the response factor.

While specific aspects and / or individual features of the invention have been illustrated and described so far, 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. For example, although the present invention is primarily illustrated and described for disposable diapers, the present invention is not limited to this embodiment. The invention also relates to products which are applied directly to the wearer (e.g., around the wearer's anus or perineal region) before, for example, or in place of disposable diapers, pull-on diapers, diaper inserts, sanitary napkins. , Tampons and the like. Moreover, of course, all combinations of these aspects and features are possible and can be a preferred embodiment of the invention. Accordingly, it is intended to cover the appended claims. Accordingly, all such changes and modifications that fall within the scope of the invention are intended to be included in the appended claims.

Claims (28)

A disposable product adapted to a wearer, comprising a biosensor comprising at least one bio-recognition element and adapted to detect a biologically targeted analyte in body secretions or on the wearer's skin. The method of claim 1, Disposable product wherein the bio-cognitive element comprises a biologically reactive agent. The method of claim 1, The biosensor is selected from the group consisting of bio-catalytic biosensors and bio-affinity biosensors, wherein the bio-friendly biosensors are preferably selected from chemoreceptor-based biosensors and immunosensors. . The method according to any one of claims 1 to 3, The bio-cognitive element is an enzyme or sequence of enzymes; Antibodies; DNA; Organelles; Membrane receptor proteins; Natural or synthetic cell membranes; Viable or non-viable bacterial cells, plant cells or animal cells; At least part of nerve bundles; At least part of the sensing organ; Disposable product selected from the list consisting of Acinetobacter baumannii TOI36 and Bacillus species TOI41. The method according to any one of claims 1 to 4, A disposable product wherein the bio-cognitive element is disposed on a substrate selected from the group consisting of polymeric materials, hydrogels, tissues, nonwoven materials and woven materials. The method according to any one of claims 1 to 5, A disposable product in which a biosensor detects a biologically targeted analyte selected from the group consisting of pathogenic bacteria, colon bacteria, viruses, parasites, bacterial toxins, fungi and enzymes. The method of claim 6, Pathogenic bacteria include Escherichia coli; Salmonella typhi; Salmonella paratyphi; Salmonella enteriditis; Salmonella typhimurium; Salmonella heidelberg; Shigella sonnei; Shigella flexneri; Shigella boydii; Shigella dysenteriae; Vibrio cholerae; Mycobacterium tuberculosis; Yersinia enterocolitica; Aeromonas hydrophila; Plesiomonas shigelloides; Campylobacter jejuni; Campylobacter coli; Bacteroides fragilis; Clostridia septicum; Clostridia perfringens; Disposable product selected from the list consisting of Clostridia botulinum and Clostridia difficile. The method according to any one of claims 1 to 7, A disposable product wherein the biosensor detects a biologically targeted analyte associated with the condition prior to the onset of clinically observable symptoms of a systemic or skin health condition. The method according to any one of claims 1 to 8, The biosensor further comprising a transducer, preferably a transducer selected from the group consisting of electrochemical transducers, optical transducers, thermal transducers and acoustic transducers. The method according to any one of claims 1 to 9, Disposable product further comprising a cleaning element of the biosensor. The method according to any one of claims 1 to 10, Disposable product wherein the biosensor is attached to the support element and / or detachable from the product. The method according to any one of claims 1 to 11, Disposable product in which a biosensor or support element is attached to the wearer's skin. The method according to any one of claims 1 to 12, If the biosensor detects a biological target analyte, the disposable product further comprises an actuator that performs a response function to provide a signal to the caregiver or wearer. The method of claim 13, A disposable product in which the responsive function is one or more functions selected from the group comprising the functions of creating void volume, treating the skin, generating a foam system, and signaling to the caregiver. The method according to any one of claims 1 to 14, Disposable product further comprising a receiver and / or a transmitter. The method according to any one of claims 1 to 15, A disposable product having a response factor of at least 5, preferably at least 10 and more preferably at least 20 when the biosensor is exposed to feces. The method according to any one of claims 1 to 16, A disposable product having a response factor of 5 or greater when the biosensor is exposed to a solution of skatole in physiological saline solution having a concentration of 180 μg skatole per gram of physiological saline solution. A disposable product adapted to a wearer, the sensor including a sensor adapted to detect a health marker or nutritional marker in the wearer's body secretion or on the wearer's skin. In claim 18, Disposable product wherein the health marker is selected from the group consisting of heavy metals, radioactive substances, fats, enzymes, endogenous secretions, protein substances, mucus and microorganisms. In claim 19, Disposable products with heavy metals lead or mercury. In claim 18, Disposable product wherein the nutritional marker is selected from the group consisting of calcium, vitamins, electrolytes, fats, fatty acids, soaps, amino acids, enzymes, bile acids and salts thereof, steroids and carbohydrates. The method according to any one of claims 18 to 21, The sensor detects target health and / or nutritional markers associated with the condition prior to the onset of clinically observable symptoms of the health- or nutritional-state, or Disposable products in which the biosensor detects target health and nutrition markers only above a predefined threshold. The method according to any one of claims 18 to 22, Disposable product, the sensor further comprising a transducer, preferably a transducer selected from the group consisting of electrochemical transducers, optical transducers, thermal transducers and acoustic transducers. The method according to any one of claims 18 to 23, Disposable product in which the sensor comprises a microchip. The method according to any one of claims 18 to 24, A disposable product further comprising an actuator to perform a response function when the sensor detects a health marker or nutritional marker. The method of claim 25, A disposable product in which an actuator modifies potential energy to perform a response function, wherein the potential energy is one or more energy selected from the group consisting of mechanical energy, electrical energy and chemical energy. The method according to any one of claims 1 to 26, Upper sheet; A back sheet combined with the top sheet; And a absorbent core disposed between said top sheet and said back sheet. The method according to any one of claims 1 to 27, Disposable products selected from the group consisting of sanitary napkins, diapers, training pants, inserts and devices for adult incontinence.