KR20020007389A - A blood detection composition - Google Patents

Abstract

The present invention relates to a chemical composition capable of detecting blood which provides a visual cue in the form of a color change. The composition comprises a color indicator that can be oxidized and a stabilizer selected from peroxides or peracids, and cyclodextrins, nitrones or mixtures thereof. These compositions are useful as components of hygiene products to predict the coming of menstruation by detecting blood and providing a visual cue before the product contains a visually indistinguishable amount of blood.

Description

Blood detection composition {A BLOOD DETECTION COMPOSITION}

Today, disposable products such as diapers, adult incontinence briefs, sanitary napkins, panty liners, interlabial devices and tampons are a means to contain, isolate and dispose of body waste, as well as the protection of women, care of infants and toddlers. And urinary incontinence are widely used in the care of adults. These products have generally replaced reusable, washable cloth garments as a preferred means for these uses because of their convenience and reliability. Disposable products react to the emissions by absorbing or blocking the body waste deposited in the product. Some disposable products include chemically reactive means to detect and signal various substances in the wearer's waste (s). However, none of these specifically detect or anticipate when menstrual associated release is about to occur and inform the wearer or guardian of the release.

The unsatisfied desire of the female consumer, which the present invention aims at, is a desire to obtain more information about the expected timing of menstruation. More generally, it is well documented that women not only want to better know and monitor the physical conditions associated with menstrual cycle conditions, but also want to be alerted to advances in associated diseases. On the other hand, the compositions used herein need to meet the highest stability criteria for the user as well as the environment.

There are many publications on general diagnostic aspects of women's menstrual cycle and information associated with the vulva / urinary tract. However, none of the references mentioned below provide a specific disclosure of the present invention.

US Patent No. 5,217,444 to Schonfeld et al., Published June 8, 1993, discloses disposable pads, such as tampons, comprising a pH indicator material that indicates the acidity or alkalinity of a liquid by color change. . The pH indicator is intended to be wetted by vaginal secretions absorbed by the pads. Depending on the pH, this will indicate the health of the vaginal tract in women.

US Patent No. 5,468,236 to Everhart et al., Published November 21, 1995, describes a disposable absorbent product incorporating a chemically reactive substance that can provide a visual indication of chemical components in absorbed liquids such as vaginal discharge. Although this patent is not specific for this particular purpose, a disposable diaper is exemplified in which a glucose indicating gel can be applied to the topsheet or absorbent core. The compound detected in the second example is nitrate as an indicator of urinary tract infection by Gram negative bacteria. In particular, Everhart provides a stable end point due to the catalyst sequence so that the display is not altered by further liquid absorption.

U.S. Patent No. 4,231,370 to Morz et al., Published November 4, 1980, discloses disposable diapers with pH sensitive wetness indicators in a solid absorbent matrix.

US Patent No. 5,823,953 to Richards et al., Published October 20, 1998, associates with or is not associated with yeast in the form of a menstrual pad or panty liner with a removable color indicating pH strip mounted on a topsheet. A self-diagnostic system for vaginal infections. The pH indicator is intended to confirm whether the pH of the absorbed liquid is above or below the threshold of 4.5 and to allow for the determination of medical examinations without the diagnosis of a doctor for the treatment of vaginal infections of yeast or non-yeast.

Buck et al. WO 97/43955, published November 27, 1997, discloses a domestic kit for collecting exfoliated vaginal cells and vaginal fluid in menstrual blood for diagnostic purposes. Fluid or cells are collected in interlabial absorption pads or pads located within a perforated mold located within the vagina to collect the fluid. The fluid can later be used for desired diagnostic purposes.

European Patent No. 704 195 to Echeveria, published April 3, 1996, is an indicator at which menstruation begins so that the wearer has sufficient time to replace the indicated absorbent product with a full size and full capacity sanitary napkin or tampon. Disclosed are a physiological detector comprising a sanitary napkin or panty liner comprising a compound that provides a cooling reaction upon liquid absorption.

Of course, many indicators are preferred which are known and generally independent of the source of liquid to be analyzed. For example, European Patent No. 386 562 to Ismael et al., Published September 12, 1990, discloses anhydrous enzyme test compositions with color indicator results. Similarly, WO 90/06511 to Buck et al., Published June 14, 1990, discloses a stabilized indicator for determining the presence of analytes in liquid samples. Similarly, WO 89/11643 to Bouse et al., Published November 30, 1989, discloses indicator compositions designed to increase the concentration range of analytes that can be analyzed.

European Patent Nos. 124 215 and 124 214 to Oksman et al., Published on November 7, 1984, both provide an indicator for wipes for occult blood, which is particularly useful for analyzing the presence of blood in the stool. It is about. Similarly, European Patent No. 93595 to Wells, published November 9, 1983, relates to a dry diagnostic aid for use in the one-step detection of hemoglobin, especially occult blood in the stool.

Rothe's European Patent No. 113 896, published July 25, 1984, relates to a chemical test strip in which a test drug is provided on a plastic film strip for quantitative evaluation. This patent takes blood and glucose tests as an example.

Roy's European Patents 101 980 and 101 979, both published March 7, 1984, relate to the determination of dehydrogenase for rapid clinical analysis and diagnostic purposes. In the latter case, it is mentioned that the carrier can be a tampon containing cellulose fibers.

Also, many literatures have been published in the medical field regarding the pathological conditions of the female reproductive and urinary organs, including the detection and treatment of the pathological conditions of the female reproductive and urinary organs.

Summary of the Invention

The present invention relates to a stabilized detection composition which provides blood signals by detecting blood in a liquid which is not identified by a general visual examination by the human eye. According to the present invention blood is generally contained in the body fluids of a mammal or in the form of an aqueous solution. Blood detection compositions include oxidizable color indicators and oxidants, such as peroxides or peracids, which are stabilized by components selected from cyclodextrins or nitrons or mixtures thereof.

In a preferred embodiment of the present invention, the oxidizable color indicator is selected from the group consisting of gum guaiac, tetramethyl benzidine or mixtures thereof. Preference is also given to compositions in which the oxidizing reactants are selected from hydroperoxides, epsa-phthalimido-peroxy-hexanoic acids or mixtures thereof.

The composition may be contained in any product, but is preferably included in a feminine disposable hygiene product capable of visually detecting an unidentifiable amount of blood in vaginal secretions deposited in the product. The article may be a laminated structure with each layer having a wearer and a garment facing surface. Generally, a product includes a liquid permeable topsheet on a wearer facing surface, a liquid barrier wall backsheet on a garment facing surface, and an absorbent core interposed between the topsheet and the backsheet. According to the invention, the product is preferably a sanitary napkin or a panty liner, in particular a thin panty liner of less than 3 mm in thickness, most preferably a panty liner suitable for wearing in elastic underwear and having a generally triangular shape.

According to a preferred embodiment of the invention, the stabilizing component is provided by cyclodextrin or nitron or mixtures thereof. The composition may preferably be provided in liquid form, for example in an organic solvent. When the composition is applied to the product, it is preferably provided in liquid form, preferably in a liquid in an organic carrier which is evaporated after the composition has been applied. Coating or preferably by spraying. Alternatively the composition may be provided in particulate form. It is also preferred that there is a tension active component such as a surfactant or polyethylene glycol to ensure that the composition or components thereof are dissolved. If the tension-active material is an organic material, it can also be used as a carrier for the composition. In this case, the organic carrier will become a waste when evaporated.

It is within the scope of the present invention to supplement the blood detector with additional physiologically relevant detectors such as additional biochemical or electrochemical or chemical detection means suitable for separating, enhancing or modifying the visual cue. Preferably such additional detection means comprise a pH indicator or progesterone hormone or estrogen hormone indicator or a combination thereof.

The present invention relates to a chemical composition capable of detecting blood which provides a visual cue in the form of a color change. The composition comprises a color indicator that can be oxidized and a stabilizer selected from peroxides or peracids, and cyclodextrins, nitrones or mixtures thereof. These compositions are useful as components of hygiene products to predict the coming of menstruation by detecting blood and providing a visual cue before the product contains a visually indistinguishable amount of blood.

Justice

As used herein, the term "absorbent product" refers to a device that absorbs and blocks body secretions, and more specifically, means a device located at or near the wearer's body to absorb and contain various secretions secreted from the body. The term "disposable" is used herein to disclose absorbent products which are not generally washed or otherwise restored or reused as absorbent products (ie, they are discarded after one use). As used herein, the term "coupled" refers to an appearance in which one element is directly fixed to another element by attaching the element directly to the other element, and one element by attaching the element to the intermediate member (s) and attaching it to the other element. It includes an appearance fixed indirectly to another member. By "integral" absorbent product is meant an absorbent product in which the individual parts are joined together to form a harmonized whole so as not to require separate operating parts such as individual handles or liners. Preferred embodiments of the absorbent article of the present invention are integral disposable sanitary napkins or panty liners, but also benefit from the present invention if disposable incontinence briefs, incontinence underwear, absorbent inserts, tampons and interlabial absorbent products are used throughout the menstrual period. Can be.

Absorbent articles according to the invention typically consist of three main elements: a topsheet which is liquid permeable to face the product user during use and to allow liquid to enter the product; A backsheet which provides liquid containment such that absorbed liquid does not leak through the product, and typically provides a garment facing surface of the product; And an absorbent core interposed between the topsheet and the backsheet and providing an absorbent capacity of the product to capture and retain liquid entering the product through the topsheet.

Many absorbent articles and structures are known in the art and have been extensively described in detail for a long time. All such materials are useful in the present invention so long as they do not interfere with the blood detection composition. In the following, only the examples which are particularly advantageous for use in the preferred absorbent articles according to the invention are mentioned. Those skilled in the art will readily identify other materials that may be particularly desirable and may be used in the physiological forecast absorbent products of the present invention.

Top sheet

Generally, the topsheet is flexible, flexible, soft to the touch and does not irritate the wearer's skin. The topsheet may preferably also have elastic properties that allow it to stretch in one or two directions. As used herein, the term "flexible" means a material that is flexible and easily matches the general form and appearance of the body.

The topsheet may be made of a nonwoven or a fabric or film that is liquid permeable by perforation. The topsheet may also be provided as a composite material or may consist of one or more layers, for example having a second topsheet or flow control layer. Such films and nonwovens or fabrics may be made of polymers such as, for example, polyethylene or polypropylene compositions. The topsheet may be provided in a material that is transparent (without color filler) or translucent (less than 15%, ie, having about half of the usual amount of filler).

Back sheet

In general, the backsheet is flexible, flexible, and soft. The backsheet prevents the absorbent absorbed clothing from absorbing the absorbent core and the blocked exudates in contact with absorbent products such as underwear. Preferably the backsheet is liquid (eg menstrual blood, sweat and / or urine) impermeable. Other flexible liquid impermeable materials can also be used, but they can be made from thin plastic films. As used herein, the term "flexible" means a material that is flexible and easily matches the general form and appearance of the body. The backsheet may also have an elastic feature that preferably draws in one or two directions.

The backsheet may comprise a composite such as a woven or nonwoven fabric, a polymerizable film, for example a thermoplastic film of polyethylene or polypropylene, or a film coated nonwoven or a fiber coated film. Typically the absorbent article comprises a backsheet of polyethylene film having a thickness of about 0.012 mm to about 0.051 mm, which may be impermeable or mechanically stretched after microperforation using an inert filler.

The backsheet is preferably breathable, ie permeable to water vapor or even more preferably air, but does not sacrifice the main purpose of protecting the leakage of absorbed liquid. The backsheet may also include one or more breathable layers to replace a single layer of breathable backsheet with two or three or more layers of different or the same material. In particular, two breathable layers are preferred breathable films, for example, one layer providing the wearer facing surface is a molded perforated film having a three-dimensional structure, and the other garment facing layer is a meltblown and spunbonded fiber, for example. It is a back sheet structure. As with the topsheet, the backsheet may be made of a transparent or translucent material that makes it easier to irradiate the detector inside the article.

Absorbent core

Typically, the absorbent core may be one entity or may comprise several layers. It may include the following components: (a) optionally a first fluid distribution layer; (b) optionally a second fluid distribution layer; (c) a fluid storage layer; (d) optionally a fibrous layer below the storage layer; And (e) other optional ingredients.

a. First fluid distribution layer

One optional component of the absorbent core of the present invention is the first fluid distribution layer. This first distribution layer is typically under and in fluid communication with the topsheet (if present). The first distribution layer captures the body fluid for ultimate distribution to the storage layer. Movement of the fluid through the first distribution layer occurs primarily in thickness, but may be distributed along the longitudinal and transverse directions of the string liner.

b. Optional second fluid distribution layer

Also an option according to the invention is a second fluid distribution layer. This second distribution layer is typically below and in fluid communication with the first distribution layer. The purpose of this second dispensing layer is to distribute it along the longitudinal and transverse directions of the string liner before it easily captures body fluid from the first dispensing layer and moves it to the underlying storage layer. This helps to make full use of the fluid capacity of the underlying storage layer.

c. Fluid storage layer

The fluid storage layer is in fluid communication with and is typically located underneath the first or second distribution layer. This preferably includes, but is not required to, superabsorbent gelling materials referred to as "hydrogel", "superabsorbent", "hydrocolloid" materials. Absorbent gelling materials are substances which, upon contact with an aqueous fluid, in particular a body fluid, absorb such fluid to form a hydrogel. These absorbent gelling materials are typically able to absorb large amounts of aqueous body fluids and further maintain the absorbed fluids under moderate pressure. Absorbent gelling materials in the prior art are typically in the form of granules of individual, non-fibrous particles. However, according to the invention, these superabsorbent gelling materials can also be provided in non-granular form, preferably in fibrous form. If no absorbent gelling material is provided, the storage layer is provided with a material commonly used as the carrier material described below.

These absorbent gelling materials in the fluid storage layer can also be homogeneously or heterogeneously dispersed in a suitable fiber matrix referred to as a carrier. Suitable carriers typically include cellulose fibers in the form of fluff or tissue used in the absorbent core. Modified cellulose fibers, such as reinforced cellulose fibers or viscose fibers, may also be used. Synthetic fibers may also be used, including cellulose acetate, polyvinyl fluoride, polyvinylidene chloride, acrylics (eg Orlon), polyvinyl acetate, non-soluble polyvinyl alcohol, polyethylene, polypropylene, polyamide (Eg nylon), polyesters, bicomponent fibers, ternary fibers, mixtures thereof, and the like. Preferred synthetic and artificial fibers have about 3 to about 25 denier per filament, more preferably about 5 to about 16 denier per filament. Carrier fibers can be provided by carding, spinning, meltblown, wet lamination, air lamination, a combination of such lamination methods, or a combination of these materials.

Also preferably, the fiber surface may be hydrophilic or treated hydrophilically. The storage layer may also include filler materials, such as Perlite, diatomaceous earth, Vermiculite, and the like, which reduce rewetting problems. The storage layer may also include a binder including, but not limited to, a latex binder, which may be sprayed into the aqueous solution onto the surface of the storage layer before curing.

If the absorbent gelling material is heterogeneously dispersed in the fiber matrix, the storage layer may be partially homogeneous. That is, it may have a distribution gradient in one or several directions within the dimensions of the storage layer. Such non-homogeneous distribution may include, for example, a stack of fiber carriers comprising an absorbent gelling material, or areas in which the absorbent gelling material has a different concentration than other areas.

If an absorbent gelling material is present, the storage layer preferably comprises 5 to 95% absorbent gelling material, preferably 5 to 50% and most preferably 8 to 35%. The storage layer may further comprise from 5 to 95% of carrier fibers, preferably from 95 to 50%, most preferably from 92 to 65% of carrier fibers.

Absorbent gelling materials suitable for use herein will most often include substantially water insoluble, lightly crosslinked, and partially neutralized polymeric gelling materials. This material forms a hydrogel when in contact with water. Such polymeric materials can be prepared from polymerizable, unsaturated, acid containing monomers. Suitable unsaturated acidic monomers for use in preparing polymeric absorbent gelling materials for use in the present invention are described in US Pat. No. 4,654,039, issued March 31, 1987 and relicensed to RE 32,649 on April 19, 1988 (Brant (Brandt), etc.). Preferred monomers include acrylic acid, methacrylic acid and 2-acrylamido-2-methyl propane sulfonic acid. Acrylic acid itself is particularly preferred for the production of superabsorbent materials, which may also have an 'although' acceptable but not optimal unless the desired transparency is too high.

Whatever the nature of the base polymer component of the hydrogel forming polymeric absorbent gelling material, such materials will generally be weakly crosslinked. Crosslinking causes the hydrogel-forming polymer gelling material to be substantially water-insoluble and crosslinking, in part to determine the gel volume and extractable polymer characteristics of the hydrogel formed from these polymerizable gelling materials. Suitable crosslinkers are well known in the art and include, for example, those disclosed in more detail in US Pat. No. 4,076,663 (Masuda et al.), Issued February 28, 1978. Preferred crosslinkers are di- or polyesters of unsaturated monovalent or polycarboxylic acids and polyols, bisacrylamides and di- or triallyl amines. Other preferred crosslinkers are N, N'-methylenebisacrylamide, trimethylolpropane triacrylate and triallyl amine. Crosslinkers may generally comprise from about 0.001 to 5 mole percent of the resulting hydrogel-forming polymeric material. More preferably, the crosslinker will comprise about 0.01 to 3 mole percent of the hydrogel forming polymeric gelling material.

Weakly crosslinked hydrogel-forming polymeric gelling materials are generally used in partially neutralized form. For the purposes of the present invention, when at least 25 mole percent, preferably at least 50 mole percent of the monomers used to form the polymer are acid group-containing monomers that are neutralized with salt forming cations, such materials are partially neutralized. Is considered. Suitable salt-forming cations include alkali metals, ammonium, substituted ammonium and amines. This% of the total monomers used which are neutralized acid group-containing monomers are referred to herein as "degree of neutralization".

While these absorbent gelling materials are typically disclosed in the form of granules in the prior art, in the present invention the absorbing gelling material may be in a non-granular form, for example a macrostructure such as a fiber, sheet or strip. These macrostructures form the particulate absorbent gelling material into agglomerates, treat the aggregated material with a suitable crosslinker, compress the treated agglomerate to form a cohesive mass, and then react the crosslinker with the particulate absorbent gelling material. It can be prepared by curing the compacted compact so as to form a composite, porous absorbent macrostructure. Such porous, absorbent macrostructures are disclosed, for example, in US Pat. No. 5,102,597 (Roe et al.), Issued April 7, 1992.

d. Selective fiber layer

An optional component for inclusion in the absorbent core according to the present invention is a fibrous layer adjacent to and typically underlying the storage layer. This lower fiber layer typically provides the same function as the second fluid distribution layer.

e. Other optional ingredients

The absorbent core of the present invention may include other optional components that are typically present in the absorbent web. For example, the reinforcing scrim may be present within or between the individual layers of the absorbent core. This reinforcing scrim must be of an appearance that does not form an inter-interface barrier to fluid movement, especially when located between individual layers of the absorbent core. Given the structural integrity generally occurring as a result of thermal bonding, reinforcing scrims are generally not required for the absorbent core of the present invention.

Another component that may be included in the absorbent core of the present invention and preferably provided as part of or adjacent to the first fluid distribution layer or the second fluid distribution layer is an odor control agent. In addition to activated carbon or other malodor control agents typically covered with other malodor control agents, particularly suitable zeolite, silica or clay materials are optionally incorporated into the absorbent core.

Physical Properties of Absorbent Core

Absorbent cores are generally non-extensible and non-elastic, but they can be extensible and can also be made to have elastic properties, depending on the material selected. As used herein, the term "extension" refers to a structure that extends in the direction of the force under external forces, such as those that occur during use, or in the direction of the component of the force if only one direction extension is provided.

As used herein, the term "elastic" refers to an extensible structure that returns at least partially to its initial state after the force that caused the extension has ceased. The absorbent core may be corrugated in one or several directions to provide some extent, and selection of elastic fibers for the structure may provide elasticity.

The absorbent core should preferably be thin. Preference is given to a thickness of less than 5 mm, preferably less than 3 mm and even more preferably 0.8 to 1.8 mm so that the resulting product also has a low thickness.

Non-limiting examples of panty liners and sanitary napkins that can be provided with blood detection compositions include those manufactured by The Procter & Gamble Company, Cincinnati, Ohio, with the following products: US Pat. Nos. 4,324,246, 4,463,045 and No. Alwayss® All Days Pantyliner with Dryweave® DriWeave manufactured according to US Pat. No. 6,004,893; All-Way Ultrathin Slender with Wings Prepared According to U.S. Patent Nos. 4,342,314, 4,463,045, 4,556,146, B1 4,589,876, 4,687,478, 4,950,264, 5,009,653 5,267,992, Maxrathin Slender Maxi; Always Regular Maxi; Always-ultra maxi with wings; Always maxi with wings; Always-long Ultra Long Maxi with wings; Always-long Long Super Maxi with wings; And winged Overnight Maxi.

Non-limiting examples of interlabial devices in which a blood detection composition may be provided include US Pat. Nos. 5,762,644, 5,885,265, 5,891,126, 5,895,381, 5,916,205, 5,951,537, 5,964,689, 5,968,026, Des 404,814 and Des 413,669.

Non-limiting examples of tampons that may be provided with blood detection compositions and applicators therefor include US Pat. Nos. 4,726,805, 4,846,802, 4,960,417, 5,087,239, 5,279,541, 5,346,468, 5,348,534, 5,531,674 And 5,566,435. In addition, the blood detection composition may also be located in a tampon that is inserted by hand.

Blood detection composition

The blood detection composition according to the present invention may provide one or more sensors for detecting blood. As used herein, the term “sensor” refers to one or more target substances (also assays) such as microorganisms or associated (biological) molecules (eg, enzyme sensors, cell sensors, tissue sensors, microbial sensors, immunosensors, and chemical or electrochemical sensors). And one or more reactive means for detecting), and further defined as a component having the ability to provide such a detection signal to the wearer, protector or operator. When referring to blood herein, typical components of blood, such as hemoglobin or iron, may of course be used as the analyte. The term "reactivity" is defined as having the ability to selectively interact with such target materials.

There are two categories of sensors with different sensitivity: biosensors and chemical / electrochemical sensors. In general, biosensors work by providing a means for specifically binding to and thus detecting a desired biologically active analyte. In this way, the biosensor is very selective even when a mixture of many chemical and biological beings is provided, for example vaginal secretions. On the one hand, electrochemical and chemical sensors that rely on chemical reaction means do not have the high selectivity or amplification properties of biosensors, but are very reliable and inexpensive (ie useful for commodities), and are often very well identified (i.e. Safe for use on human skin). Often the target analyte is a minor component of a complex mixture comprising a large number of biological and other components. Thus, in many biosensor applications, detection of target analytes of one billionth, one trillion, or even lower concentrations is needed.

According to the present invention, the blood detection composition is a specifically stabilized chemical composition. The chemical composition provides a color change as a result of the oxidation reaction and preferably comprises a color indicating component selected from gum guiac or tetramethylbenzidine or mixtures thereof. As a second component, the composition comprises peroxides or peracids as stabilized oxidizing components.

The oxidizing component (also referred to as oxidant) should be stabilized so as not to be sensitive to the storage conditions typical of the intended product (eg the warm and humid environment of the bathroom). Stabilization is provided in two ways: physicochemical stabilization by confinement of oxidants to the carrier. According to the invention, this carrier is provided by cyclodextrin. Cyclodextrins carry peroxides in the water phase (eg in high humidity) while maintaining oxidative reactivity. An alternative to physiochemical stabilization is chemical stabilization which prevents or reduces denaturation due to radicals. According to the invention it is obtained using nitron. Of course, it is also possible to use the two components together, creating an additional stabilizing effect.

If peracid is selected as the oxidant, it is preferably epsa-phthalimidoperoxyhexanoic acid. Epta-phthalimidoperoxyhexanoic acid is also advantageous by being trapped and stabilized, but may preferably be stabilized by nitrons to block or reduce degradation by radicals. In this respect, nitrons act as radical scavengers, and other radical scavengers can also be used. Of course, both stabilizer components need to be present in the mixture of hydroperoxide and epsaphthalimidoperoxyhexanoic acid.

Both color indicators and oxidizing materials are mainly reactive in aqueous solutions. Thus, once dissolved in vaginal secretions, they begin to react and are activated by the presence of blood. In order to accelerate and enhance dissolution, it is preferred that the blood detection composition comprises a tension-active substance such as a surfactant or polyethylene glycol or mixtures thereof, preferably polyethylene glycol. In hygiene products, the tension-active material should preferably be positioned to wet first before the liquid reaches the two components.

Highly preferred compositions comprise a mixture of epsa-phthalimido-peroxyhexanoic acid and gum guiac. The gum guaiak is a resin found in the trees of the Guaiacum officinale or Guaiacum santum (mainly found in Mexico or West Indies). Gum guaiak has historically been used as a flavoring for food (and therefore has a long record of safe use by humans), and is particularly known for its ability to indicate the presence of blood or hemoglybins in feces. Although gum guaiak resin is preferred according to the invention, one or both of the active ingredients, whether natural or synthetic, can be used in place of tree resin. The best known active ingredients are guiacol (OHC ₆ H ₄ OCH ₃ , CAS 90-05-1), guiaconic acid and (furo) -guaiacin.

When applied to a product, the components can be applied by coating or spraying, as long as they are applied in solution. In this case, the solvent is preferably an organic solvent. However, these solvents must evaporate below 100 ° C. unless organic solvents are chosen to provide additional benefits to the product, such as tension active materials as solvent aids. When used in absorbent articles, both components can be applied to the same layer in alternating patterns such as strips, dots or different shapes. The detector component may be provided as another part of the surface of the layer or as the entire surface of the layer (both components or one component alone). One or both of the components may be provided as a component in a powder, liquid or adhesive mixture to better coat.

Additional detectors

In one particularly preferred embodiment of the invention, the composition (or product, if the composition is applied to a product) comprises a sensor that is individually activated and acts independently to detect physiological components in body secretions in addition to the blood detector. do. The following is an example of detecting physiology coming, but this is not intended to be limiting.

Detection of blood cannot be considered 100% accurate, especially in predicting menstruation. Above all, the indicator itself needs to have high accuracy to detect only blood. It must not be sensitive to other substances to be exposed. On the one hand, the sensitivity must be high enough to detect a small amount of blood (ie, before it is visually recognized). These two competing needs must be balanced.

In addition, the presence of (latent) blood is well known as an indication of the coming of menstruation. However, low levels of blood may also be present in the vaginal secretions due to a wound or pathological condition. Thus, it would be desirable to provide a hygiene product with additional indicators that provide a second signal that menstruation is approaching. Such a signal may be provided, for example, by a change in the pH of the vaginal secretions a few days before menstruation. In addition or alternatively, hormones such as progesterone or estrogen may be used as additional indicators for predicting physiology.

In this respect, a pH sensor that can serve as a color change indicator is most preferred. pH sensors are well known and are commercially available, for example, from The Merck Company, Darmstadt, Germany. The most preferred pH sensor with a well established stability profile in this respect is carmic acid, which is used as a food dye, but changes color at pH 4-7. Carminic acid is a tricyclic compound, which has the formula C ₂₂ H ₂₀ 0 ₁₃ .

When used as color change indicators, they will produce mixed output signals in the form of multicolor displays, regardless of which additional sensors are used. It may be a mixed color representation, or it may be provided separately and detected separately as described below but work together. For example, mixing gum guaiak, which provides a color change to blue, for example, with a pH sensor that provides a color change to red, changes the color to purple to provide an indication of the proximity and high accuracy of physiological upcoming times. Need to be. Different color changes (e.g. only blue or red only) indicate that physiology may still be present or that there may be a health problem (pH changes alone may indicate an infection (but not necessarily) and indicate blood) Only (but not necessarily) can mark a wound). In the case of such a change, the packaging of the composition (or the product when combined with the product) may include instructions for the user to consider visiting a physician to medically assess whether any serious health problems (pathological conditions) are present. Can be. Of course, no color change will indicate that there is time until the next menstruation.

In addition to the electrochemical sensor, to supplement the blood detector, the cyclic nature of the hormones of the menstrual cycle (ie, a complete 28-day cycle) would be particularly useful for understanding where an individual is in the cycle. It has been used historically for the assessment of fertility, but the use according to the invention goes beyond the current use of hormones to predict ovulation and pregnancy. For example, progesterone peaks and drops just before menstruation. Estrogen also drops shortly before menstruation. Thus, in combination with other examples, for example blood detection or pH indication, analysis of one of these two hormones makes it possible to reliably predict the onset and presence of menstruation. The timing at which these hormones peak and subsequently drop allows a very accurate indication of the timing before menstruation.

The only possible disadvantage of this hormone sensor is its associated price and complexity. The lack of simple visualization makes their use in bulk products produced in large quantities very unattractive. Thus, the use of hormonal detection to predict physiology is preferably provided in conjunction with blood detection and / or pH detection in order to improve the accuracy of this forecast in the form of a completely separate detection system.

The use of hormones has also developed other interesting points in the cycle. Follicle stimulating hormone (FSH) peaks about one week before ovulation and provides more advanced timing for pregnancy planning than analysis for luteinizing hormones that show sharp peaks in ovulation. When relying solely on the analysis of luteinizing hormones, 2-3 days of fertilization can be missed. Therefore, it is highly desirable to measure both follicle stimulating hormone and luteinizing hormone with estrogen in the diagnosis of ovulation herein.

Elevated follicle stimulating hormone in nearly constant amounts is a sign that menopause is approaching. This may be useful for planning health approaches for menopause, such as hormone replacement therapy, nutritional changes and osteoporosis testing.

The compositions of the present invention may provide several additional sensor and detector systems that, for example, allow for indication or prediction of problems associated with an individual's health. Such additional sensor systems are useful when the hygiene products or compositions used primarily in a managerial situation are in the form of sprays or liquids. Typically such additional systems or biosensors include recognition elements, or molecular recognition elements, that provide detection for a particular analyte. Recognition elements include enzymes or sequences of enzymes; Antibodies; Cell membrane receptor proteins; DNA; Organelles, natural or synthetic cell membranes; Intact or partially viable or non-viable bacteria, plant or animal cells; Or biologically derived, such as plant or mammalian tissue, and generally interacting specifically with the target analyte. Recognition factors are responsible for the selective recognition of analytes and produce physicochemical signals that provide a reference for the output signal.

Biosensors may include biocatalytic biosensors and bioaffinity biosensors. In a biocatalytic biosensor embodiment, the biorecognition element is "biocatalytic" and can include enzymes, tissues, plant fragments or mammalian tissue or whole cells, and the optional binding site is "rotated" (ie, Can be used again during the detection process), resulting in a significant amplification of the injection signal. Biocatalytic sensors such as these are generally useful for real-time, continuous detection.

Bioaffinity sensors generally apply to bacteria, viruses and toxins, and include chemoreceptor biosensors and / or immunological sensors (ie, immunosensors). Chemoreceptors are complex biopolymer large combinations due in part to the ability of living organisms to detect surrounding compounds with high selectivity. Chemoreceptor 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 target biological analyte. Chemoreceptors may comprise whole or partial neural tube (eg an antenna or other sensing organ) and / or whole or partial natural or synthetic cell membranes. On the other hand, the biorecognition element of the immunosensor is generally an antibody. Antibodies are very specific and can be prepared for bacteria, viruses, microbial fragments (eg, bacterial cell walls, parasite eggs or portions thereof, etc.) and large biopolymers. Suitable antibodies can be monoclonal or polyclonal. In any case, bioaffinity biosensors are generally irreversible because the receptor site of the biosensor is saturated upon exposure to the target biological analyte. In some embodiments, biocatalytic and bioaffinity biosensors can be combined. Biocatalytic and bioaffinity biosensor systems are described in Journal of Chromatography, 510 (1990), 347-354, and Kirk-Othmer Encyclopedia of Chemical Technology, 4th edition (1992), John Wiley & Sons, NY. In more detail.

Biosensors of the invention preferably also pathogens, parasites, viruses, fungi, such as Candida albicans (Candida albican), imminent, such as the toxicity produced by the antibodies and / or microorganisms of the pathogen (i.e., the symptoms Future indications) or biologically active analytes associated with the current human systemic disease state. In addition, biosensors may target targeted biologically active analytes that are imminent or associated with current local health problems and may, for example, stress proteins (eg, cytokines) that precede clinical indications of skin irritation or inflammation. Caine) and IL-1α. In a preferred embodiment, the biosensor acts as a proactive sensor that detects an impending condition and alerts the wearer or guardian before the clinical symptoms are displayed. This gives the wearer time to prophylactic or therapeutic treatment to significantly reduce the severity or course of symptoms. In addition, by detecting the presence of a target biological analyte in the wearer's body waste, the biosensor detects residual contamination on surfaces such as skin in contact with the biosensor and provides appropriate signals.

The signal generated by the recognition element or elements is visually transmitted to the wearer or guardian, for example, through a visible color change by the human eye. The signal can be qualitative (eg indicating the presence of the target biological analyte) or quantitative (ie measuring the amount or concentration of the target biological analyte). In either case, the signal is preferably persistent, i.e. stable and readable over time (typically at least the same size for the life of the product). In addition, the sensor may be adapted to detect and / or signal only the concentration of the target biological analyte above or below a predetermined threshold level (eg, where the target biological analyte is typically present in body waste).

As disclosed above, the target analyte adjusted to be detected by the biosensor of the invention is a pathogenic microorganism, for example a pathogenic microorganism associated with human gastrointestinal disease, in particular causing diarrhea. Severe chronic diarrhea can cause weight loss and permanent physical and mental delay. Non-limiting list of pathogens that biosensor 60 can be detected is (known as Escherichia coli, typically E. coli (E. Coli).) Escherichia coli; s. Typhimurium (S. typhi), S. Para typhimurium (S. paratyphi), S. Enter Reedy Tees (S. enteriditis), S. Typhimurium (S. typhimurium) and Estonian. Salmonella (Salmonella) strains containing the Hay del bug (S. heidelberg); Shigella small Nei (Shigella sonnei), Shigella flex Neri Shigella (Shigella) strains containing a (Shigella flexneri), Shigella look-di (Shigella boydii) and (Shigella dysenteriae) for Shigella di Centennial Ria; The Vibrio cholera (Vibrio cholerae); Mycobacterium tuberculosis cool-to-Bercy (Mycobacterium tuberculosis); Ecija California Yen Lou Collier Romantica (Yersinia enterocolitica); To remain on Pseudomonas dihydro-pillar (Aeromonas hydrophila); Flash Omo eggplant Siegel Roy des (Plesiomonas shigelloides); Seed. Jeju you (C. jejuni) and seeds. Campylobacter (Campylobacter) strains such as E. coli (C. coli); Plastic foil teroyi des jilriseu (Bacteroides fragilis); And seeds. Seb tikum (C. septicum), Mr. Peoreu spring Regensburg (C. perfringens), Mr. Botulinum (C. botulinum) and seeds. Diffie and chamber include any of the various pathogenic strains, such as Clostridia (Clostridia) strain comprising a (C. difficile). this. A non-limiting example of a commercially available biosensor that is tuned to detect E. coli is marketed as Test Kit # 4001 from AndCare, Inc. of Doohan, North Carolina, ABTECH, Scientific, Inc. provides a "bioanalytical biotransformer" marketed as BB Au-1050.5-FD-X, which is a polypeptide, enzyme, antibody or DNA fragment By covalently immobilizing them covalently on their surface (for microorganisms or other target biological analytes as disclosed herein). Other suitable microbial biosensors are described in US Pat. No. 5,869,272 (Gram negative microorganisms); 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 that can be adjusted to detect the biosensor of the invention may also be a virus. These may include diarrhea induced viruses such as rotavirus or other viruses such as rhinovirus and human immunodeficiency virus (HIV). Exemplary biosensors modulated to detect HIV are disclosed in the aforementioned US Pat. Nos. 5,830,341 and 5,795,453.

In another embodiment, the target analyte that is adjusted for detection by the biosensor of the invention may also be parasites, especially those that inhabit the gastrointestinal tract for some period of the life cycle. Such parasites may include protozoa, worms and other gastrointestinal parasites. Other examples of which can be detected parasite enta Moe's Bar Heath Tolly Utica (entamoeba histolytica) (causing amoebic dysentery), tree Pana Crew paper (trypana cruzi) (Shah is causing the disease), and Flavian Sumo Rhodium eight Shifa Room (plasmodium falciparum ).

In another embodiment, the target analyte adjusted for detection by the biosensor of the invention is a fungus such as Candida albican . In addition to the pathogens, certain beneficial colonic bacteria such as bifidobacteria may be bacteria (Bifidobacteria) and Lactobacillus (Lactobacillus) strains also it is detected as a health indicator / or measured.

The analyte of interest that the biosensor of the invention is modulated to detect may also be a protein or antigen associated with skin troubles. Preferably these analytes can be detected at the surface of the skin, preferably before clinically observed skin irritation appears. These are stress proteins such as cytokines, histamines, and interleukins (eg, IL-1α, IL-2, IL-3, IL-4 and IL-8) and interferons (including interferons a and g) It may include other immune response factors, including. Again, they can be detected by the biosensor 60, preferably before clinically observable redness, irritation or dermatitis is initiated. In addition, the biosensors of the invention can be adjusted to detect enzymes or other biological factors associated with skin irritation (eg, diaper rash), including trypsin, chymotrypsin, and lipase.

The biosensors of the present invention may also include biometric systems comprising enzymes or binding proteins, such as antibodies immobilized on the surface of a physicochemical converter. For example, certain strains of bacteria can be detected by biosensors using antibodies raised against bacterial strains. Alternatively, the target bacterium may be present in an extracellular product of the subject bacterium, such as a biorecognition element (including antibodies and synthetic or natural molecular receptors) specific for the toxicity produced by the strain (eg E. coli ) . Can be detected. Exemplary enzymatic electrodes that can be used for the detection of phenol (eg in urine or feces) are named "Remote Electrochemical Sensors" by Joseph Wang et al., Dated October 14, 1997, respectively. Tyrosanase system disclosed in U.S. Pat.No. 5,676,820 and U.S. Pat. Electrodes or polyphenol oxidase enzyme electrodes.

In any of the embodiments described above, a particular microorganism may be detected directly or by binding to a toxin, enzyme or other protein produced by the microorganism, or an antibody specific for that microorganism, such as a monoclonal antibody. Exemplary biosensors modulated to detect proteolytic enzymes are disclosed in US Pat. No. 5,607,567 and toxins are disclosed in US Pat. Nos. 5,496,452, 5,521,101 and 5,567,301.

The biosensor of the invention may include one or more "pre-action sensors." This is particularly useful in embodiments in which detection of the desired biologically reactive analyte precedes the onset of clinically observable health signs. The term "pre-action sensor" as used in this patent application detects a signal or change on the wearer's body (i.e. skin) or in a waste, i.e. an input associated with the occurrence of a direct or at least impending health or skin-related event. It means a sensor that can. The pre-behavior sensor may respond to one or more specific inputs as described above.

Proactive sensors can detect variables that are directly associated with, or at least correlated with, the occurrence of an impending event, particularly a systemic or skin health event or disease (ie, an indication of clinically observable signs or symptoms). Impending events that may be detected or predicted by the proactive sensor of the present invention may include other types of diseases or medical conditions of the wearer, such as diarrhea disease, skin irritation or rash (including candidiasis) and / or parasitic invasion. have. The biological analyte detected may be one or more steps recovered from the actual indication of clinical signs. For example, biosensors can detect possible precursors of the disease (eg, stress proteins can be induced after the skin is contaminated with feces, and subsequently clinically observable skin irritation can occur). . Variables that relate to an event are any measurable input, and signals such as one or more of the possible inputs listed above relate to the occurrence of an event within the framework of the system's criteria (ie, signals due to waste or wearer). Proactive sensors in the product can measure one or more different inputs to predict an event. For example, pre-behavior sensors can monitor for Candida albicans and vaginal secretions on the skin (i.e., detecting residual contamination), both of which are signals that can be followed by skin rashes.

In embodiments of biosensors in which the biorecognition element does not produce a signal (e.g. color change) that is readily visible, the biosensor may transmit physiological signals from the biorecognition element to the wearer, guardian or component of the product It may include a diverter in communication with the biometric element to convert the signal into useful signals for the actuator. Exemplary diverters include electrochemical diverters (including potentiometers, amperometric and conduction diverters), optical diverters (fluorescence, bioluminescence, total internal reflection resonance and surface plasmon resonance, as known in the art). ), Thermal transducers and acoustic transducers. A power source, such as a small 3-volt clock cell or printed thin film lithium battery, can be connected with the biosensor to provide any desired power.

Claims (8)

Oxidizable color indicators; And a component selected from cyclodextrins or nitrons or mixtures thereof as stabilizers of peroxides and peroxides, or one or both of the two crowds of nitrons as stabilizers of peracids and peracids. A stabilized, detection composition that provides a visual cue to detect blood, which is not identified, in a liquid, such as a mammalian body fluid or an aqueous solution. The method of claim 1, Wherein the oxidizable color indicator is selected from gum guaiac, tetramethylbenzidine or mixtures thereof, preferably gum guaiac. The method according to claim 1 or 2, The peroxide is a hydroperoxide composition. The method according to any one of claims 1 to 3, The peracid is epsa-phthalimidoperoxyhexanoic acid. The method according to any one of claims 1 to 4, Composition in liquid form, preferably in an organic carrier. The method according to any one of claims 1 to 4, Composition in particulate form. The method according to any one of claims 1 to 6, A composition further comprising a tension active material. An article for visual blood detection, wherein a liquid is detected in a liquid in a visually indeterminate amount of blood comprising a carrier material to which the detection composition of claim 1 has been applied.