MXPA00012991A - Device having fecal component sensor - Google Patents

Abstract

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

Description

DEVICE THAT HAS SENSOR OF THE FECAL COMPONENTF FIELD OF THE INVENTION The present invention relates to devices that have sensors adapted to detect and / or measure the components of feces as indicators of health and / or nutrition.

BACKGROUND OF THE INVENTION At present, devices are known that comprise sensors to detect various diseases or health conditions of individuals by analyzing the blood by health markers. The widely known ones include blood glucose monitors that allow patients with diabetes to monitor their blood glucose levels and determine the amount of insulin required to balance their sugar levels. Additionally, portable devices with sensors adapted to detect levels of alcohol (ie, ethanol) in the exhaled breath of suspected intoxicated drivers are widely known and employed by various law enforcement agencies. These devices have generally replaced traditional laboratory tests as the preferred means for these applications because of their convenience and reliability. The devices respond to target analytes predefined in the blood or exhaled breath and provide an indication of the presence and / or level of the target analyte. However, none of these specifically detects the chemical and / or biological components of the subject's feces that function as markers for potential problems of health and / or nutritional status. Accurate, not convenient means are available for caregivers and / or medical personnel to quickly provide data on faecal health and / or nutritional markers, especially those associated with diarrheal disease, poisoning, and malnutrition. Additionally, devices do not predict when a health or nutrition related event is about to occur and indicate to the subject or person seeking care that prophylactic or therapeutic action is required before the onset of clinically observable symptoms.

BRIEF DESCRIPTION OF THE INVENTION The present invention is directed to a device comprising a sensor adapted to detect one or more specific markers of health and / or nutrition in feces. The device may also indicate the care of the occurrence or amount of the marker.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a plan view of a device made in accordance with the present invention adapted to be temporarily fixed to the skin of a subject or to a durable or disposable device of the subject, the device having sensors adapted to detect three different anahtos and an indicator adapted to provide an indication of the presence of each analyte. Figure 2 shows an alternative embodiment of the present invention. Figure 3 shows an alternate embodiment of the present invention. Figure 4 shows an alternative embodiment of the present invention. Figure 5A shows an ideal output function of a discontinuous sensitive system of the present invention having an individual threshold level.

Figure 5B shows an ideal output function of a discontinuous sensitive system of the present invention having multiple individual threshold levels. Figure 6A shows an exemplary output function of a discontinuous responsive system of the present invention together with first, second and third derivatives of the output function. Figure 6B shows a transfer function of a control system having a series of first order intervals having an identical time constant. Figure 7 shows a perspective view of a bodily wasting isolation device of the present invention, in a compressed state before activation. Figure 7A shows a sectional view taken along the TATA line of the Figuré. ? 2.

DETAILED DESCRIPTION OF THE INVENTION As used herein, the term "devices" refers to devices or Apparatus that analyzes body wastes, particularly faeces, for the chemical target and / or biological analytes useful as markers of health and / or nutrition. He 2C device is usually reusable. The term "reusable" is used herein to describe devices that have at least one component that is not discarded immediately after its initial use, but which is employed in later uses of the device. At least one portion of the device may be disposable. The term "disposable" is used here to describe absorbent devices that are generally not intended to be washed or restored or reused in another way (these are intended to be disposed of after a simple use).

The device 20 also preferably includes at least one sensor 60 adapted to detect one or more markers of health and / or nutrition in the body waste and which have the ability to provide a signal of said detection to the subject, the person seeking the Care or an actuator. The term "subject", as used here, refers to a human whose waste will be analyzed. The term "caregiver" 7 as used herein, refers to an individual responsible for caring for the subject, such as a nurse or a relative. "medical personnel", as used herein, refers to individuals trained in the medically related field, such as doctors, nurses and technicians.

Jß laboratory. In certain examples, these terms may be used interchangeably. For example, the subject can also be a caregiver, the caregiver can be a. medical professional, etc. As used herein, the term "sensor" refers to a device that is capable of detecting an event or parameter that is associated with an event. A parameter associated with an event is any reasonable signal that is correlates with the occurrence of an event within the framework of the system (ie, a signal caused by the waste, the subject, or a component thereof). Sensors include anything that corresponds to one or more inputs ^^ specific. The sensors can be chemical, electrochemical, biochemical, or biological. The devices of the present invention specifically comprise sensors that provide a signal to the subject, to the person seeking the care and / or medical person, indicating the presence and / or concentration of one or more markers of health or nutrition in the body waste such as faeces, urine or menstruation . The signal can be an optical signal, including visual signals (for example, a colorimetric or fluorescent indicator), a chemical signal (for example, a change in the pH, enzymatic activity, or concentration of any of the other chemical species), or an electrical signal.

"Health markers" and "nutritional markers" (for example, in human fecal eses), as used herein, refer to any of the elemental, chemical or biological components that may be found in the waste, and any of the combinations or relationships between (for example, proportions, etc.) of the components that have a definite relationship with the health of the subject (for example, disease, infection, poisoning, etc.) and nutritional status, respectively. The nutritional status of the subject includes, for example, metabolic efficacy, nutrient deficiencies, absorption or malabsorption of nutrients, consumption of food and drink, food allergies (e.g., peanuts), food intolerance (e.g. ^ 0 lactose intolerance), ecology of colonic bacteria (eg, beneficial bacteria such as bifidobacteria and lactobacilli), and total energy balance. Health markers may include heavy metals (eg, lead, mercury, etc.), radioactive substances (eg, cesium, strontium, uranium, etc.), enzymes, endogenous secretions, proteinaceous matter (eg, molds) , mucosa, and microorganisms '.5 (described in greater detail in the biosensor section) that may be related to various health problems such as infection, diarrhea, pain or gastrointestinal disease, or poisoning. Heavy metals, especially in ^^ Certain developed countries and in older and / or less affluent areas of developed countries, are a serious health risk. For example, lead poisoning and mercury can occur when ingesting these heavy metals from environmental sources (for example, from paint with pfome, unregulated heavy industries, etc.) and can be fatal. More commonly, low-level poisoning through 'These and other heavy metals result in delayed intellectual and / or physical development, especially in children that may occur over a prolonged time and that have long-lasting effects on the individual. Proteinaceous masses, such as molds (for example, in urine) can be detected by targeting the Tamm-Horsfall protein to a target. A suitable example of a sensor for the Tamm-Horsfall protein is described in U.S. Patent No. 5,780,239, which is incorporated herein by reference. Suitable sensors for heavy metals and / or discriminating means useful for sensors they are described in greater detail in the patents of the United States Nos. 5,595,635; 5,865,972; 5,814,205; 5,468,336, all of which are incorporated herein by reference. Non-limiting examples of nutritional markers include calcium, vitamins, (eg, thiamine, riboflavin, niacin, biotin, folic acid, pantothenic acid, ascorbic acid, vitamin E, etc.), electrolytes (eg, sodium, potassium, O chlorine, bicarbonate, etc.), fats, fatty acids (long and short chain), soaps (for example, calcium palmitate), amino acids, enzymes (for example, lactose, amylase, iipase, trypsin, etc.), bile acids and salts of them, steroids, and carbohydrates. For example, calcium malabsorption is important because it can lead to long-term de fi iciency in bone mass. Although the importance of calcium absorption in adults, particularly in mature women, is highly publicized, it is also an important consideration in children (especially babies). The baby's diet can impact the absorption of calcium and, therefore, the mass and / or bone density. It has been shown, for example, that the position change of! Palrnitic acid in triglycerides in baby formula from 2-position (ie, similar to breast milk or human), to position 1 and / or 3- (for example, in some formulas for baby), it results in less locking of the palmitic acid "structure" of the triglyceride, and therefore the absorption, of this nutrient by the body. Unbound palmitic acid binds calcium in the digestive tract like soap (ie, calcium palmitate) and exits the body in fecal eses, (this process is described in more detail in Archieve of Disease in 5 Childhood (Nov. 1997) 77 F178-F184). Therefore, calcium and / or soap contained in fecal eses is a potential means to determine the calcium absorber through the digestive system. Suitable colorimetric calcium sensors based on Arsenazo III (acid medium) and cresolphthalein complexone (basic environment) are available from Sigma-Aldrich Chemical of St. Lois, MO., As catalog number 588-3 and 587-A, respectively. Other illustrative sensors for e! calcium and / or the means of discrimination for the sensors is described in greater detail in the United States patents Nos. 5,705,620; 5,580,441 and 5,496,522, all of which are incorporated herein by reference. The sensors of the present invention may be associated with a carrier structure. The carrier structure may retain, stabilize and / or at least partially encapsulate the sensor. The examples of the carrier structures include one or more layers of woven and non-woven, elastic or inelastic webs, films, foams, canvases, hydrogels. and similar. The sensor may be fixed to the country structure, retained between two or more components, layers, or folds of the north structure, or may be sealed within the carrier structure. The structure The carrier may optionally comprise a composition adherent to the foot or adhesive or other means of attachment to secure at least a portion of the carrier structure to the device or a component thereof or to the skin of the subject. In addition, at least one portion of the carrier can be soluble in water. In certain embodiments of the present invention, the sensor 60 may comprise a biosensor or biological sensor. As used here, the term "biosensor" is defined as a component comprising one or more media 'biologically reactive adapted to detect one or more pathogenic microorganisms of the target or related biomolecules (eg, an enzyme sensor, an organelle sensor, tissue sensor, microorganism sensor, immunosensor or electrochemical sensor. The term "biologically reactive" is defined as having the ability to selectively interact with, and preferably bind, pathogenic microorganisms of the target and / or related biomolecules as described herein. In general, biosensors function by providing a binding means of specific way, and therefore detect, a biologically active target analyte. In this way, the biosensor is highly selective, even when presented as a mixture of many chemical and biological entities, such as faeces. Often the biological target analyte is a minor component of a complex mixture comprising a multiplicity of biological components and other components. Therefore, in many applications of the biosensor, the detection of white particles to parts per billion, parts per trillion, or even lower levels is necessary. Therefore, discrimination ratios of approximately 107-108 or greater may be required for the biosensor to recognize the biological analyte of the blank in a complex mixture. The biosensor of the present invention may comprise a biological recognition element or a molecular recognition element, which provides highly specific binding or detection selectively for a particular target. The biological recognition element, or system, can be a biologically derived material such as an enzyme or enzyme sequence; an antibody; a membrane receptor protein; (DNA, an organelle, a natural or synthetic cell membrane, a bacterial cell, plant or animal that is intact or partially viable or not viable, or a piece of plant or mammal tissue, and generally functions to specifically interact with the analyte The biological recognition element is responsible for the selective recognition of the analyte and the physical chemical signal that provides the basis for the output signal.Biosensors can include biocatalytic biosensors and 5 bioaffinity biosensors.In the biocatalytic biosensor modalities , the biological recognition element is "biocatalytic" and may comprise an enzyme, organelle, piece of plant or mammal tissue, or all cells, the selective linking sites "move" (ie, they may be used again during the detection process), resulting in a significant amplification of the input signal.The biocatalytic sensors s such as these are useful for real-time continuous sensing. Bioaffinity sensors are generally applicable to bacteria, viruses, and toxins and include biosensors based quimoreceptores and / or immunological sensors (ie immunosensors). The chemoreceptors are complex biomolecular cross-assemblies responsible, in part, for the body's viable ability to sense chemicals in their environment with high selectivity. Biosensors based on chemoreceptors comprise one or more natural or synthetic chemoreceptors associated with a means to provide und se? Al (visual, electrical, etc.) of the presence or concentration of a biological target analyte. In certain embodiments, the chemoreceptor may be associated with an electrode (i.e., an electrical transducer) to provide a detectable electrical signal. The chiropreceptors may include bundles of total or partial nerves (e.g., from an antenna or other sensing organs) and / or membranes with total or partial natural or synthetic cell. On the other hand, in the elements of biological recognition of the immunosensors are generally antibodies. The antibodies are highly specific and can be directed to bacteria, viruses, fragments of microorganisms (for example, bacterial cell walls, parasite eggs or portions thereof, etc.), and larger biomolecules. Suitable antibodies can be monoclonal or polyclonal. In any case, bioaffinity biosensors are generally irreversible because the biosensor receptor sites become saturated when exposed to the biological analyte of the target. In certain embodiments, biocatalytic or bioaffinity biosensors, such as RNA / DNA assays or other high affinity binding systems, may be combined and where the initial event of biological recognition is followed by the biological amplification of the signal. For example, a specific bacterium can be detected by a biosensor comprising genetic material such as DNA, as an element of biological recognition and PCR amplification (ie, ratio of the polymerase chain) to detect small numbers of small organisms (eg, less than or equal to about 500). The biocatalytic and bioaffinity biosensor systems are described in more detail in the Journal of Chromatoqraphy, 510 (1990) 347-354 and in Kirk-Othmer Encvclopedia of Chemical Technology, 4th ed (1992), John Wiley & Sons, NY, the disclosure of which is incorporated by reference here. The biosensors of the present invention preferably prefer to detect biologically active parasites related to the states of the imminent human systemic disease (i.e., probable future present presentation of symptoms) or current, including but not limited to, pathogenic bacteras, parasites ( for example, at any stage of the life cycle, including eggs or portions thereof, cysts, or mature organisms), fungal viruses such as Candida Albicans, pathogen antibodies and / or microbiologically produced toxins. Additionally. the biosensor can target biologically active anayites related to imminent or current localized health problems, such as stress proteins (eg, cytokines) and lL-1a (interleukin 1-alpha) that can proceed to the presentation clinical irritation or inflammation of the skin. In preferred embodiments, the biosensor functions as a proactive sensor, detecting and indicating to the subject or the person seeking care or medical personnel of an imminent condition prior to the presentation of clinical symptoms. This gives time to the administrator of the prophylactic or therapeutic treatments to the subject, which can reduce significantly, but avoid the severity and duration of the symptoms. In addition, the sensor 60, by detecting the presence of an objective biological analyte in the subject's body waste (e.g., fecal es), can detect residual contamination on a surface, such as the skin, in contact with the biosensor, and provide the right signal. 5 The physical-chemical signal generated by the biogenetic recognition element or elements can be visually communicated to the person providing the care or medical personnel (ie, through a change of color visible to the human eye). Other modes can produce optical signals, which may require other instrumentation to increase the signal. These include fluorescence, Q bioluminescence, total internal reflectance resonance, surface plasmon resonance, Raman methods and other laser-based methods. Illustrative surface plasmon resonance biosensors are available as IBIS I and IBIS II from Xan'fec Anal sepsysteme de Muehster, Germany, which may comprise bioconjugated surfaces as biological recognition elements. In a way, bind me, the signal can be processed through an associated driver which, for example, can produce an electrical signal (for example, current, potential, inductance, or impedance) that can be displayed (for example , on a reading host, such as an LED or LCD screen) or which actuates an audible or palpable signal (eg, vibration) or which can trigger an actuator, as described herein. The signal may be qualitative (for example, indicating the presence of the target biological analyte) or quantitative (that is, a measurement of the quantity or concentration of the target biological analyte). In these modalities the transducer can optionally produce an optical, thermal or acoustic signal. In any case, the signal can also be durable (i.e., stable and readable for a duration of time typically at least the same as the lifetime of the device) or transient (i.e., recording a real time measurement). ). Additionally, the signal may be transmitted to a remote indicator site (e.g., through a cable or transmitter, such as an infrared or RF transmitter) including other sites within or on the remote device or devices. In addition, the sensor 60, or any of its components, can be adapted to detect and / or indicate only the concentrations of the target biological analyte above a predefined threshold level (eg, in cases where the target biological analyte is normally present in body waste or when the concentration of the analyte is below a level of "danger"). As described above, objective analytes which the biosensors of the present invention are adapted to detect may be pathogenic microorganisms such as the pathogenic microorganisms involved in gastrointestinal diseases especially those which result in diarrhea. This type of pathogen is particularly important to monitor because the number of children who become seriously ill or die every year from diarrheal diseases. It has been found that severe chronic diarrhea can result in weight loss and in the retardation of permanent physical and mental development. A non-limiting list of the pathogenic bacteria that the sensor 60 can detect includes any of the various pathogenic strains of Escherichia coli (commonly known as E. Coli); red mullet strains, including S. typhi, S. paratyphi, S. enteriditis, S. Typhimurium, and S. heidelberg; strains of Shigella talee such as Shigella sonnei, Shigella flexneri, Shigella boydii, and Shigella dysenteriae; Cholera vibrio; Mycobacteria tuberculosis; Yersinia enterocolitica; Aeromonas hydrophila; Plesiomonas shigelloides; Campylobacter strains such as C. jejuni and C. coli; Bacteroides fragilis; and Clostridia strains, including C. septicum, C. perfringens. C. botulinum, and C. difficile. A non-limiting example of a commercially available biosensor adapted to detect E. coli is available from AndCare.Inc. of Durha, NC, as test case # 4001. As another non-limiting example, ABTECH, Scientific, Inc., of Yardley, PA offers "biotransducto.es bioanalíticos", available as BB Au-1050.5-FD-X, which can be made biospecific (for microorganisms or other objective biological analytes as described here) covalently immobilizing polypeptides, enzymes, antibodies, or fragments of DNA to their surfaces. Other suitable microbial biosensors are described in U.S. Patent Nos. 5,869,272 (organisms of negative gram); 5,795,717 (Shigella); 5,830,341; 5,795,453; 5,354,661; ,783,399; 5,340,488; 5,827,651; 5,723,330; and 5,496,700, all of which are incorporated herein by reference. The target analytes of the biosensors of the present invention are adapted to detect can also be viruses. These may include viruses that induce diarrhea such as rotavirus, and other viruses such as rhinovirus and human immunodeficiency virus (HIV). An illustrative biosensor adapted to detect HIV is described in U.S. Patent Nos. 5,830,341 and 5,795,453, referred to above. The disclosure of each of these patents is incorporated by reference herein. In alternative embodiments, the target analytes that the biosensors of the present invention are adapted to detect may also be parasites, especially those that inhabit the gastrointestinal tract during some point in their cycle. of life. These parasites can include protozoa, worms, and other gastrointestinal parasites. Other examples of parasites that can be detected include entamoeba histolytica (which causes amoebic dysentery), trypana cruzi (which causes Chagas disease), and plasmodium falciparum. In still other embodiments, the target analytes that the biosensors of the present invention are adapted to detect may be fungi such as Candida albicans. In addition, to the pathogen bacteria, certain beneficial colon bacteria can be detected and / or measured as an indicator of health, such as the Bifidobacteria and Lactobacillus strains. The target analytes that the biosensors of the present invention are adapted to detect may also be proteins and antigens related to skin pain. Preferably, these analytes are detectable on or on the surface of the skin, preferably before the presentation of clinically observable skin irritation. These can include proteins in strains such as cytokines, histamine, and other immune response factors including interleukins (such as IL-1a, II-2, IL-3, »IL-4, and iL-8) and interferons (including interferons a and g). Again, these are preferably detectable by the sensor 60 before the onset of reddening, irritation or clinically observable dermatitis. Additionally, the biosensors of the present invention may be adapted to aerate enzymes, or other biological factors, involved in skin irritation (e.g., honeycomb dermatitis), including trypsin, chymotrypsin, and lipase. The biosensors of the present invention may also comprise biological recognition systems, including enzymes or binding proteins such as antibodies immobilized on the surface of the physical-chemical transducers. For example, a specific strain of bacteria can be detected in Iraq from biosensors that use antibodies raised against that bacterial strain. Alternatively, objective bacteria can be detected by a biological recognition element (including antibodies or synthetic or natural molecular receptors) specific for extracellular products of the target bacteria, such as toxins produced by that strain (e.g., E. coli). ). Illustrative enzyme electrodes that can be used to detect phenoids (e.g., in urine or fecal eses) include tyrosinase-based electrodes or polyphenol oxidase enzyme electrodes described in U.S. Patent No. 5,676,820 entitled "Electrochemical sensor. remote "issued to Joseph Wang et al. on October 14, 1997 and in U.S. Patent No. 5,091, 299 entitled" An Enzyme Electrode for Use in Organic Solvents ", issued to Anthony PF Turner and others on February 25 of 1992, respectively. Both of these patents are incorporated by reference herein. In any of the above examples, the specific microorganism can be directly detected or can be detected by ligating a toxin, enzyme or other protein produced by the organism or an antibody, such as a ÍD monoclonal antibody, specific for the organism. Exemplary biosensors adapted to detect proteolytic enzymes are described in U.S. Patent No. 5,607,567, and toxins in U.S. Patent Nos. 5,496,462; 5,521, 101; and 5,567,301. Any of the sensors 60 of the present invention can 1d understand one or more "proactive sensors". This is especially < It is useful in the modalities where the detection of the health and / or nutritional marker precedes the beginning of clinically observable symptoms of health. As used in this application, the term "proactive sensor" refers to a sensor that is capable of detecting changes or signals in the individual's body (ie, the skin) or in waste, is say, inputs, which are directly related or, at a minimum, correlate with the occurrence of an event related to health or imminent or potential oiel. Proactive sensors can respond to one or more specific inputs as described above. A proactive sensor 60 can detect an impending event or detect a parameter that is directly related, or at a minimum, correlates with the occurrence of an imminent event, particularly a systemic or skin health event (ie, the presentation of clinically observable indications or symptoms).

An impending event that can be detected or predicted by a proactive sensor 60 of the present invention may include early stages of lead poisoning, early stages of malnutrition and / or vitamin deficiency caused by malabsorption of nutrients, diarrhea disease, irritation or skin rash (including candidiasis), and / or other types of maies or medical conditions of the subject such as an infestation of parasites. The detected health, the nutritional marker and / or the biological analyte may be one or more steps that are removed from the actual presentation of the clinical symptoms. For example, the sensor can detect potential precursors of the above conditions (eg, faecal contamination of the skin that can predict the production of proteins which may, however, precede clinically observable skin irritation). A parameter that correlates with an event is any signal, measurable input, such as one or more of the potential inputs listed above, that correlate with the occurrence of the event within the system's reference frame (ie, a signal caused for waste or for the subject) Proactive sensors 60 in a device can measure one or more different inputs in order to predict an event. For example, the proactive sensor 60 can monitor Candida albicans in the fecal and residual colon bacteria on the skin (i.e., detect residual contamination) both of which are signals that can precede the irritation of the foot! . In biosensor modalities wherein the biological recognition element does not produce an easily visible signal (eg, a color change), the sensor 60 may include a transducer in communication with the biological recognition element in order to convert the physical signal Chemistry from the biological recognition element in a signal usable for the subject, the person seeking care, or the component of the device (for example, an actuator). Illustrative transducers may include electrochemical transducers (including potentiometric, amperometric, and conductometric transducers), optical transducers (including fluorescence), bioluminescence, total internal reflection resonance, and surface plasmon resonance), thermal transducers, and acoustic transducers, as are known in the art. A power source, such as a miniature 3-volt clock battery or a thin-film printed lithium battery, can be connected to the sensor 60 to provide any required power. The effectiveness of the biosensors of the present invention can be measured with the response factor test described in the Test Method section below. The response factor describes the proportion of the response of the biosensor when exposed to the fecal test material compared to the biosensor response when exposed to physiological saline and is useful in determining the sensitivity of the biosensor to the biosensor. Expected biologically active analytes have preferentially found in fecal es es versus urine. The biosensors of the present invention preferably have a response factor of at least 2, 3 or 5 more preferably at least 10 and still more preferably at least 20 when exposed to the stool test material in solution. aqueous or urine test that has a concentration of 1 gram of fecal test material per 1 gram of physiological saline. (The physiological saline solution is used here to represent the antecedent input signal, which is present in most natural environments such as the body's aqueous fluids). These biosensors are able to clearly distinguish between the presence of the fecal material and the presence of the physiological saline solution with respect to a specific biologically active target analyte for the faeces. One way to detect fecal eses is to detect eskatol, a substance commonly found in fecal material. It has been found that the concentration of eskatol in fecal eses is approximately 180 micrograms per gram of fecal material while the level of eskatol in urine has been found to be substantially lower. Eskatol is generally a product of the microbiological degradation that originates from! Tryptophan catabolism in the intestinal system. In a preferred embodiment of a eskatol detector biosensor, the biosensor comprises genetically engineered microorganisms which assimilate eskatol and / or other substances. The assimilation of the specific eskatol substances can be measured, for example, through the consumption of oxygen during the assimilation process. Suitable microorganisms for detecting eskatol include Acinetobacter baumannii TO136 (FERM P-12891), Japanese Patent Publication JP05304947), and Bacillus sp TO141 (FREM P-12914), disclosed in Japanese patent publication JP05304948). Suitable biosensors that include these microorganisms are available, for example, from the Instituir für Chemoupd Biosensorik de Urster. Germany, under the designation Mikrobieíie Sensoren. If the microorganisms are incorporated in a biosensor, they can be immobilized in the biosensor by techniques known in the art. as entrapment, adsorption, crosslinking, encapsulation, covalent attachment, any combination thereof or the like. In addition, immobilization can be carried out on many different substrates as is known in the art. In certain preferred embodiments, the immobilization substrate can be selected from ae! group of materials based on polymer, hydrogels, iisus, non-woven matepals, woven materials. In certain embodiments, the sensor 60, including any of the biosensor modalities, may comprise, lay on, or be operatively associated with, a microchip, a MEM (i.e., micro-electromechanical system), or an integrated circuit. Biosensors based on microchips can be known as "biochips". Regardless of the type of sensor, the microchip can comprise a multiplicity of sensor components that have similar or different sensitivities, kinetics, and / or target analytes (ie, markers) in an array adapted to detect different levels or combinations of said analyte. or analytes. In addition, each sensor in each array can provide a different type of signal, including those types disclosed herein, and may be associated with different actuators and / or controllers. Also, each sensor in an array can operate independently or in association with (for example, in parallel, combination, or series) any number of other sensors in this array. Any of the sensors 60 of the present invention can be placed on and / or operatively connected to any portion of a device that will be exposed to the input that the sensor is designed to detect. For the purposes of the present invention, the term "operatively connected" refers to communication means so that > the sensor 60 may signal any portion of the device 20 when the sensor 60 detects an "in." The sensor 30 may be separated and operatively connected to another portion of the sensor 60, to another sensor 60, to an actuator 70, a controller 80 or to some other portion or component of the device 20. "Operably connected" may, for example, include a communication means such as an electrical connection by means of a wire or conductive member, by means of a transmitted signal such as radio frequency, infrared or other transmitted frequency communication Alternatively, the proactive sensor 60 can be operatively connected by means of a mechanical connection such as a pneumatic or hydraulic connection The sensor 60 can be integrated with the device 20 or can be installed by the person providing the care or medical personnel.The sensor during the course of the analysis, may also become disconnected at least partially. The device can be attached to the skin of the individual (ie the patient or subject). The sensor can be permanently or unattably fixed (for example, through a mechanical fastening system such as Sailboat or a water soluble adhesive) to a support structure, including adhesive tapes, cellulose or synthetic wefts, non-woven foams, films , canvases, foams, and the like. In addition, the sensor 60 may be contained entirely within the device such as the device 20 or may have a receiving portion located in the device so that they come in contact with the desired entry and another portion ta! as a transmission portion located either on the device or outside it. The sensor 60 can be external to the device 20 and be operatively connected to some portion of the device 20 so that the sensor 60 can detect an external input to the device 20 and provide a signal to a controller and / or a tuner. In some modalities, the sensor may be separated from the device, for example, applied separately to some portion of the subject via adhesive or other means as is known in the art, and / or may have one or more separate components of the device. The device can be durable, so that it is completely >; reusable, or may be partially disposable, containing at least one disposable item. For example, the device may comprise, or be used in combination with, disposable components and / or items, including disposable probes and / or disposable probe covers, adhesive fixation means, carrier structures, power supplies such as batteries, sensors or components thereof and / or colorimetric or fluorescent test strips. The device of the present invention, as described above, is adapted to detect markers of health and / or nutrition in body wastes, such as faeces. The device, or a component thereof, can be portable. The devices or components that are worn may include elastics and other belts, disposable or durable garments, disposable absorbent articles, such as diapers, disposable waste disposable articles such as colostomy bags, catheters, artificial stomachs, adhesive strips and capable of fixing removable manner such as diagnostic bands and strips, adhesively fixed devices, and other articles capable of being carried as are known in the art.

Additionally, the device, or a component thereof, can be releasably attached to any of the items that can be carried earlier or any other carrier structure that can be affixed to the subject or to a usable article. The adhesively attached usable device is shown in Figure 1. The embodiment of the device shown in Figure 1 comprises three sensors adapted to detect the presence of three different analytes and a screen that is adapted to provide an indication of the presence of the analytes. (However, any number of sensors capable of detecting any number of different analytes is possible.) The sensors and the screen are fixed to a carrier that removably attaches to the skin of a subject through an adhesive. In alternative embodiments, the device may be a manual unit similar in size and shape to manual oral electronic thermometers, a non-limiting example of which is shown in Figure 2. In this embodiment, a sensor, or sensor system, adapted to Measuring three different health and / or nutritional markers is housed at one end of the device which is adapted for insertion into a body cavity or a waste sample. A screen is arranged at the opposite end for convenient reading of the analysis of said markers. Depending on the sensor type, ie, especially optical sensors such as laser or LED sensors, a disposable probe cover can be provided for hygienic use and easy cleaning. Figure 3 shows a similar modality adapted for use without the disposable probe cover.

In alternate embodiments, the device can be a table or a bench cover or a portable unit, as represented in Figure 4. The arrangement shown in Figure 4 comprises a sensor or a sensor system adapted to measure or detect one. or more than different markers of health and / or nitricional in body waste, as described above. The device may comprise as a sensor element containing the sensor or sensors fixed via a data cable to the main body of the device. The disposable covers of the probe can be used to provide hygienic use. The energy for the device is preferably of an electrical nature, although other power sources, such as mechanical, chemical or electrochemical, are contemplated. Electric power can be provided as direct current, such as from a disposable or rechargeable battery, or an alternating current, such as coming from a generator or a wall input. Modes are contemplated where the device is powered or the battery is recharged by solar energy. The signal provided by the device, or a component thereto, may be qualitative, such as an indication of the presence of a chemical or quantitative biological analyte ta! as a concentration or relative quantity, as described above. The output c signal may comprise a signal, reading or simple indication, or it may comprise any number or combinations of these outputs. The signal can be transient (that is, in real time) or durable, ta! as a "peak" or "initial occurrence" reading.

The contact with the device or a component thereof can be passive or active. By "passive contact" it is implied that the waste makes contact with at least one sensor portion of the device without any external assistance from the person seeking care or medical personnel. For example, passive contact can occur in embodiments where at least a portion of said device, such as a sensor, is adhesively fixed to the skin of the subjects in the perianal region prior to the application of a diaper. In this case, the sensor would make contact with the waste as a result of the normal process of defecation. By "active contact" it is implied that the subject, person providing care, or medical personnel may perform actions to effect the contact of the waste and at least one sensor portion of the device. For example, the waste / device contact is active in an ert mode where a probe or sensor is manually inserted into a waste sample previously collected. In certain modalities, the subject, person seeking care, or medical personnel, may be required to take a sample, or aliquot, of the waste or treat the waste to be analyzed with a preparatory treatment, ta! as a regulator or sterilization, before testing with the device of this invention The device can release, inject, or treat the waste, or a sample of! same, with a reagent, u; regulator, stabilizer, indicator, or other analysis aid as is known in the art. + - +2 In some embodiments, a means or cleaning element may be provided to allow the person providing the care or medical personnel e! sufficiently cleaning the body waste of the sensor 60 to allow a visual determination or reading (especially for sensor modes that provide such a signal). The cleaning element may include a weave (cellulose or synthetic), nonwoven sponge, film, foam, rigid or semi-rigid roller-like element, and the like provided in the device and adapted in such a way that the element can be used to clean the sensor screen. The cleaning element can be fixed at least partially to a component of the device, such as an upper cover, near the sensor 60 by any means known in the art. The cleaning element may optionally comprise water or any other known cleaning aid to facilitate cleaning of the subject or the sensor screen. In certain preferred embodiments, the device 20 preferably also comprises an actuator. As used in this application, the term "actuator" refers to a device that comprises "potential" and means to transform that potential to execute or activate a "sensitive function". The potential of the actuator may comprise a stored or potential energy or stored material. The actuator can therefore execute or activate a sensitive function by transforming the 1Q potential energy in kinetic energy or by means of the release or supply of a stored material. A "sensitive function" is defined for the purposes of the present invention as a function performed on the corporeal waste, the subject, the device, or a component or components thereof, or a signal to the subject or the person seeking it. the care. A component of body wastes can '15 include, for example, moisture, electrolytes, enzymes, volatile gases, bacteria, blood, etc. A component of the subject can also include skin, genitals, the rectum, the rectal sphincter muscle, etc. Potential energy can be stored as mechanical, electrical, chemical or thermal energy. The "kinetic energy" as used in this application refers to the ability to do work or to perform a sensitive function as described before (for example, the expansion of a compressed device, the rotation of a rotated device, a gel that moves as the phases change, coating or treatment of the skin or stool, inhibition of an enzyme, adjustment of the pH , etc.). An actuator of the present invention can release the potential energy to execute or activate a sensitive function on the waste, the subject, the device or a component thereof. The release of potential energy can transform mechanical, electrical, chemical or thermal energy into mechanical, electrical or chemical kinetic energy to perform the sensitive function. The actuators can be activated by a threshold level of one input to release the potential energy in order to execute a sensitive function on the input or can respond continuously on the input as described below. For example, a compressed foam has stored compressive mechanical potential energy and can provide mechanical kinetic energy when released. A twisted foam has stored mechanical torsional potential energy that can provide mechanical kinetic energy, that is, rotation, when it is released. In addition, stored chemical, electrical or thermal energy can be used to release kinetic, electrical, mechanical, chemical or thermal energy. A The actuator of a device, for example, may include one or more of the following: stored lotion, antimicrobial or antifungal agents, stool modification agents, enzyme inhibitors, pH regulators, dyes, pressurized gas, a compressed foam , a pump, a closed system liquid transport member, an electrically sensitive gel, a pH sensitive gel, a gel sensitive to the salt concentration ,: eic. Potentiated energy can be stored in any form sufficient to maintain / restrict until required. Suitable means to maintain and / or restrict such energy include batteries and / or capacitors, tensioned materials ^^ elastic, torsional or compressively or structures, in the form of unreacted reagents, and materials capable of performing physical or chemical functions (eg, absorbers, emollients, pH regulators, enzyme inhibitors, stool modification agents; compressed gases, etc.). Alternatively, the actuator of the present invention may comprise a quantity of stored material having the ability to execute or activate a sensitive function on the body waste, the subject, the device, or any component or components thereof. In one embodiment, for example, the actuator may release or supply a stored material that performs a sensitive function. In this embodiment, the actuator can be activated by a threshold level of an input to release or discontinuously provide the stored material at a given time or it can release or supply the material continuously. The actuator may, for example, include stored lotion, skin care compositions, antimicrobial or antifungal agents, stool modification agents, enzyme inhibitors, pH regulators, dyes, etc. In certain preferred embodiments, the material may be supplied by an actuator such as a material! Elastic expansion, a high pressure gas released, etc. Figures 7 and 7A illustrate an actuator 90 comprising a resilient compressed material 94, such as a foam, at least vacuum sealed within a differentiation device 91. A pressure differentiating device, as used herein, is any device or structure that can maintain an elastic material in a compressed state (for example, it can store energy by providing a compression ascender on the compressed elastic material 94). A "compressed state" is defined as the condition in which a material is maintained at a volume "less than if it would have material if it were not forced and under applied pressure of 0. With respect to the elastic materials, a compressed state can be usually achieved by applying a pressure to a surface of the material or by any other means known in the art The pressure differentiating device may, for example, comprise a vacuum sealed bag or tensioned materials, such as bands or elastic yarns. or inelastic, strips, films, non-woven materials, canvases, or foams, which squeeze an elastic material Preferably, the compression of the elastic material maintained by the pressure differentiating device 91 can be at least partially reduced (i.e., the material compressed elastic 94 can by least expand partially) through an activating mechanism. any element or device, such as a sensor, actuator, or combination thereof, which responds to an input to effect the updating of the pressure in the pressure differentiating device 91 and allow the compressed elastic material 94 to expand at least partially . By releasing the compressed material, such as when a biologically active target analyte is detected, the compressed elastic material can expand and release the stored material. In some embodiments, it may be advantageous that the locker comprises a hollow space 96. The elastic material may comprise any resilient material, including but not limited to an EVA foam such as those available from Foamex Coiporation of Eddystone, Pennsylvania identified as SIF / 210PP1 or the Aquazone 80A foam, or Sentinel Products Corporation f Hyannis, MA identified as MCI 900 EVA 2! B / ft3, or a HIPE foam as described in U.S. Patent No. 5, 260, 345 entitled "'Absorb! Foam Matepais For Aqueoue Body F luids and Absorbent Articles Containing Such Materials "issued for de Marai? et al- e! November 9, 1993; US Patent of North American No £., 38? '. 207, entitled Thin-Until-Wet Absorbent Foam Materials For Aqusous Body Huids And Process For Making Same "issued to Dyer et al, on February 7, 1995, and US Patent No. 5,625,222 entitled" Absorbent Foam Materials For Aqueous Fluids Made From High Internal Phase Emulsions Having Very Hing Waler-To-Oil Ralions emitted to DesMarais et al. on July 22, 1997. (Each of the patents identified above are incorporated by reference herein). In some embodiments of the present invention, the pressure differentiating device 91 may comprise a soluble pouch. The soluble pouch can be soluble in the presence of one or more different types of entry, such as water, urine, faecal enzymes, a pH level, etc. and may have physical and / or chemical characteristics (e.g., thickness) that can be designed to set a threshold level of the lightening required to dissolve the bag. The soluble bag can, for example, comprise a plastic film which is soluble in water as a PVA film provided by Chris-Crafí Company Producís, Inc. of Souíh Holland, IL as the movie MONOSOL M7031, or H.B. Fuller Company of Yes. Paul, MN as HL 1636 or HL 1669-X. The film thickness, for example, can be modified to provide a desired glazing. The film used can, for example, have a thickness on the scale from about 0.0012 cm to about 0.0038 cm. An HL 1636 film having a thickness of about 0.0025 cm, for example, will be acclimated with a moisture content of about 0.049 grams per square inch. The actuator may be positioned in and / or operatively connected to any portion of the device that will allow the actuator to perform a sensitive function on the operator. body waste, the subject, the device or a component thereof. The device 20 may also include a controller. A "controlled." it is defined for the purposes of this application as a disposicle that receives an input from a sensor and determines whether one or more actions are to be taken. The controller can receive a signal from the sensor 60 and direct the harrow to execute a sensitive function on the body waste, the subject, the device or a component thereof. Alternatively, the actuator can receive the signal directly from the sensor 60 and perform a sensitive function on the body waste, the subject, the device or a component thereof. The conductor may include materials that undergo a chemical or physical change, may be a chemical, mechanical or electrical device that processes the information from a sensor, ele. the biosensor 60 may include an inducer comprising a multilayer film of Langmuir-Blodgett, at least a portion of which may function as a controller, wherein one or more layers includes a biological recognition element. When in contact with water, Langmuir-Blodgett films are known to spontaneously rearrange, resulting in regions with more layers than the original film and other layers having fewer layers. This reorganization may expose the biological recognition element to the environment preferably in the presence of water, such as in body waste, which may contain the target biological analyte. This can reduce false positives and / or extend shelf life of the biosensor.

Allerinarily, an electrical conductor that receives signals such as the electrical potential from an electrochemical sensor can receive and monitor multiple electrical signals and can actuate the actuator repeatedly. The driver can be integral with the sensor component, integral with the actuator component or a separate component of the system. The confrolador may content content entirely within the device such as the device 20 or may have a portion located in the device and a portion located outside the device or may be completely outside the device 20. A controller or a portion of the controller may be located orally to one or more sensors 60, one or more actuators 90, either portion of the driver or another portion of the device 20. The controller, for example, may receive a signal from the sensor 60 and provide a signal to the actuator, for example, by a radio frequency transmission ( rf). Although the elements are Different uclurals can execute the functions of! sensor 60, the actuator and the driver, the functions of the sensor 60, the actuator and / or the coiler of the present invention do not need to be executed by discrete structural elements. The functions of the sensor 60 and the controller, for example, can be executed by the same structural element. A "sensitive system" is defined for the purposes of this application for a system that includes a sensor 60 and an actuator that acts on the body waste, the subject, the device, or a component thereof when the sensor 60 detects the entry of appropriate activation. Upon detection of a given parameter of enlrada, the actuator effects the release of stored energy or material to perform a sensitive function. When a proactive sensor 60 detects an imminent event, the actuator effects the release of the stored energy. By delecting an input signal before the impending event, a sensitive system within the device can be triggered to prepare the event or to indicate the person seeking care or the subject of the impending event. This allows the construction of devices in which the waste management technology is initially concealed or non-obstrusive, but which is available at, or just before, the time of need and / or in which the device can provide the person who seeks care or the subject of the opportunity to prepare an event in advance (for example, administer prophylactic treatment to the subject in the event of pathogenic microorganisms deified or residual fecal contamination). Without considering the specific input, the sensor 60 in these modes can trigger an actuator to execute an action on the device, the subject or the environment to prepare for the occurrence of the eve or to provide a signal to the person seeking the care that the impending event is about to occur. If the sensor 60 comprises a sensitive system, an actuator can be operated by different sensors and / or indicators, or different actuators can be operated by different sensors and / or signals. Alternatively, a sensor and / or a signal can drive multiple actuators. A responsive system can respond in a "continuous" or a "discontinuous" form.As used in this application, a "sensitive sensitive system" refers to a sensitive system in which the output is quantitatively dependent on the quantity of the enlrada. , ie, continuously increasing amounts of input are required to effect the continuously increasing quantities of the output, or where the output of the sensitive system comprises a passive release of a stored material.

A superabsorbenle polymer placed in an absorbent core of a device, for example, provides a coninuous response in which the output is quantitatively dependent on the amount of the enirate, i.e. as the amounts of the liquid waste in contact with the polymer increase. superabsorbent, an increasing amount of the polymer that conliene that liquid hasla the capacity of the polymer is overwhelmed. A stequeometric chemical reaction is another example of a system that has a continuous response to the rising output. In the reaction A + excess B - > C, for example, the amount of excess B converted to C is stoichiometrically and therefore "continuously," related to the amount of A available in the system. However, a "discontinuous sensitive system" refers to a sensitive system having an output function that is essentially independent of the amount of the emitted beyond a threshold level. For example, when one or more threshold levels of a given input are met, the sensitive system can release all or a predesignated portion of its stored energy or supply, that is, actively transport, all or a predesigned portion of its stored material. to execute a specific sensitive function. In an ideal embodiment of the present invention, the output function, f (x), includes a function of "stages" as shown in Figure 5A. In this mode, the rate of change in the output with increasing levels of input (d (output) / d (input)), that is, the slope or first derivative f (x) of the output function f (x) is essentially preferably zero when the amount of the input is above or below the threshold level. However, at the threshold level, the rate of change d (output) / d (input) preferably approaches infinity. Therefore, in the ideal discontinuous response, the limit of the function f (x-e) as e? 0 is not equal to! limit of the function f (x + e) as e? O, that is, lim f (x-_)? lim f (x + ¿). However, the present invention recognizes that in the physical world a change of instantaneous level at the threshold level is not necessary and may not be possible in many instances. In a preferred embodiment, it is only necessary that the output function has a virtual lapa change with each small change in the input in or around the threshold level of the entrance. Therefore, the present invention contemplates a discontinuous sensitive system of the present invention having an output function that responds in a sufficiently discontinuous manner to the transition region so that the output function has at least a minimum relative degree of inclination in the transition region. In future, you do not want to limit yourself to one method IfJ is a particular description or modeling of a discontinuous system, in a preferred method of determining whether or not a given output function is executed in a sufficiently discontinuous manner as defined for the purposes of the present invention, the slope of the When the point of inflection is compared with the relative inclination of a line between the first and last points of the transition region. For example, Figure 8A shows a graph of an illustrative output function, f (x) together with aligned graphs of 1 first, i '(x), second f "(x), and third, i'" (x ), derived from the illustrative output function. The output function f (x) describes the effect of the input (x or!) On the output or response (R (l)). For the purposes of the present invention, the region of transitions is defined as the region between the relative maximum, R (l?), And the minimum, Rfl?), Of the second derivative, f '(x), of the output function, t (x): the maximum reiaíiva. R (l?), And the minimum relay, R (l¿-), are points at which the third derivative, f '"(x), is equal to zero.The inflection point, l0, is defined as the point in the transition region in which the second derivative, f "(x), equals zero, that is, d2R | 25 - I = 0.

I2 I l = l0 The comparison of the inclination of the output function at the inflection point for the inclination of a line between the first and the last points of the transition region can be described by the equation: dR | (? RT) - I = k di! I = l0 (? Lt) In this equation dR / dl at the point of inflection is the first derivative of the output function at that point. The term? Lt is the change in the input for the sensitive system between the first, and the last, 12, points of the region of transition, that is,! 2 - 1-, and the term? Rt is the change in the response of the output function between the first and last points of the transition region, that is, R (! 2) - R (). The coefficient k is a proportional constant that describes the relative inclination of the inclination of the exit function at the inflection point, l0, compared to the inclination of a line between the first and last points of the transition region. In order for the sensitive system to have a disconnected output function, the proportional constant k must be at least about 2.0, preferably at least about 3.0, more preferably at least about 5.0, and even more preferably of at least about 10.0 with at least about 100.0 being e! more preferred. In certain embodiments, the relative degree of inclination in the transition region of a discontinuous responsive system can also be modeled by a transference function of a contol system. that there is a series of an integer, n, first-order intervals with an identical time signature. The transfer function of the responsive system is defifor the purposes of the present invention as the Laplace relation that transforms the outputs (response variable) to the enlrada (disturbance variable). See, for example, Robert H. Perry & Don Green, Perry's Chemical Enaineer's Handbook. Sixíh Ed., Chap.22 (McGraw Hill, Inc. 1984).

As shown in Figure 6B, the relative degree of inclination of an output function can be approximated by the formula: KG. (S) = K / (Ts + 1) n in which KG. (S) is the function of transfer, k is a proportional element, T is the time constant of the system, and n is the integer number of the first-order time intervals. In this model, as the number n increases, the inclination of the output function in the region of transition also increases and the model begins to approach a disconnected sensitive system. Certain discrete sensitive systems of the present invention can be modeled preferably by the above formula when n is greater than or equal to about 25, with n being greater than or equal to about 50 being more preferred and n being greater than or equal to about 100. which is the most preferred. As shown in Figure 5A, a sensitive system of the present invention may include an individual threshold level at which e! The sensitive system can release all of its stored energy to execute a specific sensitive function or it can include multiple threshold levels at which the system can release a predesigportion of its stored energy to execute one or more specific sensitive functions at each of the levels of energy. threshold. In a modality that has an individual threshold level, which has all its energy stored to execute the complete sensitive function, when that threshold level is reached. In the individual threshold mode, in this example, the discontinuous sensitive system includes a system having two states such as active or inactive. A threshold amount of one set such as an objective biological material is present in the absorbent device, the sensitive system can perform an individual sensitive function on the waste, the subject, the device or a component thereof, fai as providing a visual signal easily deiecíable by the subject or the person seeking care. For man, the discontinuous sensitive system can perform a function similar to a one-time switch that changes from one phase to another in the presence of a threshold level of one line. Allemally, as shown in Figure 5B, the sensitive system can have multiple threshold levels at which when each threshold level is reached the system can release a certain "quanta" of energy or provide a certain amount of material to perform a function. of specific response.

In this embodiment, when each threshold level is reached, a portion of the complete sensitive function can be executed and / or different different independent sensitive functions can be performed in response to different threshold levels that are reached. In each transition region, the sensitive system responds essentially to the same transition region in the same individual modality described above. In addition, a sensitive system can monitor multiple inputs such as one or more pathogenic bacteria and / or one or more enzymes? Fecal, and execute a c more sensitive functions when the levels of umbrai of the different inputs are reached or can execute a sensitive function only when two or more of the threshold levels of the different inputs are combined. A controller can monitor multiple different inputs and execute a different sensitive function when the umbraí level of different inputs is reached. Alternately. the control can execute a mare logic OR function such that a sensitive function can be executed when one or more threshold levels of multiple strings are reached. The controller can also execute a logical AND type of link function such that a sensitive function can be executed when each threshold level of two or more different inputs are reached. A sensitive system may also comprise a "closed cycle" or "open cycle" system. A "closed cycle" system which is also referred to as a "replenishment control cycle" system includes various sensor and actuator 60 components and performed a sensitive function on the enirate. In some preferred embodiments, the system may also use a detection or measurement of an element or a parameter of the output condition as at least one activator of the sensitive function that is executed on the input. The output condition may be the state of the input condition after the actuator has had the opportunity to execute a sensitive function on the input condition. The sensitive function can be executed when the exit condition reaches a threshold level, or U) can be executed only when the exit condition and one or more conditions are met. Acting on the entry may include acting on the detected element, for example, detecting a microorganism and acting on the microorganism, or it may include acting on a composition of which the detected element is a black component, for example. , detect a fecal bacterium and act on the fecal mass or fecal residual feces on the skin of the subject. As described above, the feedback control cycle includes at least two distinct components: the sensor 60 and an actuator. The sensor 60 detected an event, or a parameter associated with that event. The actuator receives a signal and executes the sensitive function on the input condition detected by the sensor 60. The re-feed-in confrol cycle may also include a co-applicant. In this case, the sensor 60 can provide a signal to the correlator and the actuator can direct the actuator to execute a sensitive function on the condition of enira. The coiler can be a separate component of the sensitive system or the function of the coiler can be executed by the sensor 60 and / or the actuator. 25 The feedback control cycle can be "non-modulator" or "modulator". In a sensitive system in a "non-modulator" feedback cycle, the sensitive system acts as a one-time switch in which the actuator performs a sensitive function of the enlrada when the threshold level of the output condition is met. For example, the sensor 60 can detect the presence of, or measure the concentration of, a specific pathogenic microorganism, and the actuator may indicate to the person seeking care of a potential incipient infection. In this example, the actuator acts on the input detected by the sensor 60. However, a "modulator" re-feed control cycle includes a sensor 60, an actuator and a coni rolator. In a cycle of conirol of modulative feedforwarding, the output condition is monitored constantly or repeatedly and the controller _) Detects the actuator to execute a sensitive function on the input in order to maintain the output condition at a desired fixed point or within a desired range or provides a continuous measurement of the level or concentration of > objective biological analysis. However, an "open cycle" system is a system that responds to the input to execute a sensitive function without using the feedback, that is, the output has no effect on the detected input recorded by the system. An open cycle system can include a sensitive system having an individual device that executes the functions of both the sensor 60 and the actuator or can have different sensor 60 components and actuator in which the actuator acts on another part different from enirada. Alernalivamenle. A sensitive open-cycle system may include a sensor 60 that detects body waste or a component of that body waste and an actuator that performs a sensitive function in a continuous or discontinuous manner over another part of the enclave marked by the sensor 60.

TEST METHODS Response factor test: With the response factor test as described here below, the response of a quantitative sensor can be measured in accordance with a reaction to the exposure for a specific substance or composition. The specific substances or compositions for which this test is suitable include: fecal test material in aqueous solution having a concentration of 1 gram of fecal test material per one gram of physiological saline; . fecal test material in the test urine solution that has a ^ £ concentration of 1 gram of fecal material per one gram of test urine solution; urine test solution; a solution of eskatcl in physiological haze solution having a concentration of 180 micrograms of eskatol per gram of physiological saline; and physiological saline solution. 15 - All body parts are performed (37, JCelsius). The method includes the following steps in the following order: 1) Record the quantitative response of the sensor after the ^^ exposure to physiological saline solution for 24 hours. The antecedent response is the maximum response recorded. 20 2) Expose the sensor to the specific substance or composition. 3) Record the quantitative response of the sensor while the sensor is still exposed to the specific substance or composition for 24 hours. The answer to the substance is the maximum response recorded. The response factor is obtained by normalizing the response of the substance with the antecedent response In the case that, the response factor is less than 1, the reciprocal value of the response factor is reported as e! response factor.

Although the modalities and / or individual features of the present invention have been illustrated and described, it would be obvious to one skilled in the art that various other changes and modifications may be made without departing from the spirit and scope of the invention. Furthermore, it should be apparent that all combinations of these modalities and features are possible and may result in preferred embodiments of the invention.

Claims (55)

1. A device comprising: an adaptive sensor for detecting health markers in the body waste or on the skin of the user.

2. The device according to claim 1, wherein the sensor comprises a biosensor that has a biological recognition element.

3. The device according to claim 1, wherein the fecal waste comprises stools.

4. The device according to claim 1, wherein the sensor provides a signal to the subject, to the person providing the care or to an actuator. The device according to claim 1, wherein the health marker is selected from the group of: heavy metals, radioactive substances, fats, enzymes, endogenous secretions, proleinaceous matter, mucosa and microorganisms. 6. The device according to claim 5, wherein the heavy metals are lead or mercury. The device according to claim 1, wherein the sensor detects a target health marker associated with a health condition before the clinically observable symptoms of the condition begin. The device according to claim 1, wherein the sensor detects the health marker only above a predefined threshold level. 9. The device according to claim 1, wherein the sensor further comprises a transducer. 10. The device according to claim 9, wherein the transducer is selected from the group including electrochemical, optic, thermal and acoustic transducers. The device according to claim 4, wherein the signal is a visible indication. 12. The device according to claim 4, wherein the signal is qualitative or quantitative. 13. The device according to claim 4, wherein the signal! It is durable throughout the life of device use. The device according to claim 1, wherein the device further comprises a cleaning element for the sensor. 15. The device according to claim 1, wherein the sensor is fixed to a support element. 16. The device according to claim 15, wherein the support element is a adhesive tape. 17. The device according to claim 1, wherein the sensor comprises a microchip. 18. The device according to claim 17, wherein the microchip comprises an array of sensors. 19. The device according to claim 1, wherein the sensor is detachable from the device. 20. The device according to claim 1, wherein the sensor can be adhered to the user's skin. 21. The device according to claim 1, further comprising an actuator that performs a sensitive function when e! sensor detects the health marker. 22. The device according to claim 21, wherein the actuator transforms a potential energy to execute the sensitive function, the potential energy being one or more selected from the group of mechanical energy, electric energy, chemical energy. 23. The device according to claim 1, wherein at least a portion of the device is capable of being carried by a user. • 24. The device according to claim 1, wherein the device is manual. 25. The device according to claim 1, wherein the device is powered by electrical energy. 26. The device according to claim 1, wherein the disposable device is wasted with a material selected from the group that includes:

"Eactive, a regulator, an indicator 27. The device according to claim", wherein the device comprises a laser diode sensor 28. The device according to claim 1, which .5 further comprises a sensor adapted for detecting toxic markers in body waste or on human skin. 29. A device comprising: an adaptive sensor for detecting numerical markers in the body waste or on the user's skin. • The device according to claim 29, wherein the sensor comprises a biosensor having a biological recognition element. 31. The device according to claim 29, wherein e! Fecal waste comprises feces. 32. The device according to claim 29, wherein the sensor provides a signal to the subject, to the person seeking the care or to an actuator.

33. The device according to claim 30, wherein the nutritional marker is selected from the group of: heavy metals, radioactive substances, fats, enzymes, endogenous secretions, proieinaceous maige, mucosa and microorganisms. 34. The device according to claim 33, wherein the heavy metals are lead or mercury. 35. The device according to claim 29, wherein the nulricional marker is selected from the group of: calcium, vitamins, electrolytes, fats, fatty acids, soaps, amino acids, enzymes, bile acids and salts thereof, steroids and carbohydrates. 36. The device according to claim 29. wherein the sensor detects a nutritional marker associated with a health or nutritional condition before the clinically observable symptoms of the condition begin. 37. E! disposition according to claim 29, wherein the sensor detects the nutritional marker only above a predefined threshold level. 38. The device according to claim 29, wherein the sensor further comprises a transducer. 39. The device according to claim 38, wherein the transducer is selected from the group that includes electrochemical, optic, thermal and acoustic transducers. 40. The device according to claim 32, wherein the signal is a visible indication. 41. The device according to claim 32, wherein the signal is qualitative or quantitative. 42. The device according to claim 32, wherein the signal is durable during the entire life of the device's use. 43. The device according to claim 29, wherein the device further comprises a cleaning element for the sensor. 44. The device according to claim 29, wherein the sensor is fixed to a support element. ^ 45. The device according to claim 44, wherein the

5 Support element is an adhesive tape. 46. The device according to claim 29, wherein the sensor comprises a microchip. 47. The device according to claim 46, wherein the microchip comprises an array of sensors. 48. The device according to claim 29, wherein the sensor is detachable from the device. 49. The device according to claim 29, wherein the sensor can be adhered to the wearer's skin. 50. The device according to claim 29, further comprising an actuator that performs a sensitive function when the sensor detects the nutritional marker. 51. The device according to claim 50, wherein the actuator transforms a potential energy to execute the sensitive function, the potential energy being one or more selected from the group of mechanical energy, electric energy, chemical energy. 52. The device according to claim 29, wherein the device is manual. 53. The device according to claim 29, wherein the device is powered by electrical energy. 54. The device according to claim 29, wherein the device treats the waste with a material selected from the group including: a reagent, a regulator, an indicator. 55. The device according to claim 29, wherein the device comprises a laser diode sensor.