WO2007073139A1

WO2007073139A1 - Diagnostic diaper

Info

Publication number: WO2007073139A1
Application number: PCT/MX2006/000141
Authority: WO
Inventors: Nancy OLIVARES GONZÁLEZ
Original assignee: Olivares Gonzalez Nancy
Priority date: 2005-12-21
Filing date: 2006-12-08
Publication date: 2007-06-28
Also published as: MXNL05000103A

Abstract

The invention relates to a disposable diaper including: a plurality of urine-sensitive indicator reagents which are used to detect levels of glucose, ketone bodies, heavy metals such as lead, nitrites and specific weight and which are fixed to the internal absorbent lining of the diaper; and a plurality of faeces-sensitive indicator reagents which are used to detect fats and proteins and to perform a Clinitest and viral tests. The inventive diaper is used to monitor a patient's urine and faeces in order to detect any unusual substances with the aid of the aforementioned indicators which the evaluator uses to compare the colours of the different reagents of the indicators of the diaper and to detect the existence of any abnormal substances.

Description

DIAGNOSTIC diaper

BACKGROUND OF THE INVENTION

A. FIELD OF THE INVENTION. The present invention is related to disease diagnostic means by using reagent strips, and more particularly with a disposable diaper for infants or adults that includes a plurality of urine sensitive indicator reagents to detect levels of: glucose, ketone bodies, heavy metals such as lead, nitrites and specific gravity, fixed to the internal absorbent cover of the diaper; and a plurality of excrement-sensitive indicator reagents, to detect: fat, proteins and perform Clinitest test and viral tests

B. DESCRIPTION OF RELATED ART.

At present, there are reagents that placed on a strip serve to guide diagnoses such as pregnancy tests as well as substances that are only found in urine in pathological situations.

Urine studies are used as diagnostic tools that provide a qualitative report of the presence of substances that can be detected in urine in pathological situations through chemical reactions that have color changes on contact with the rectors and detect reducing substances such as sugars, bilirubins, leukocytes, nitrites, urobilinogen, proteins, pH, blood, specific gravity, ketones, contaminants (lead, mercury, etc.) as well as medications, neurotransmitter derivatives, organic hormones etc. Said color changes that occur in each case are compared with control tables indicating the color corresponding to a positive result of the presence of a substance.

There are also sophisticated laboratory machines that, through the use of said reagents or some others, of electrophoresis and molecular weight detection techniques, are able to determine the above-mentioned substances qualitatively and / or quantitatively. These methods are sometimes complemented with microscopy and microscopic analysis of the urine sample to be evaluated in a totalitarian way. Some diseases depend on diagnostic systems such as those mentioned above to be detected, especially those that due to their nature are silent. Such silent diseases, as they do not provide clinical data, delay the diagnosis as well as its timely treatment, so that periodic screening programs for infants are indispensable and is a worldwide medical practice that is carried out by pediatricians or doctors. family members This practice is generally carried out more efficiently during the first months of life since it is controlled at the same time with the vaccination chart that is applied to infants, but when these schemes are spaced, the parents or guardians leave the consultation of the control of the child and only go to the consultation when the infant files a medical complaint because of which the control of the detection of the diseases is lost in a timely manner. In addition, in many occasions the father is not able to identify when the infant is presenting a disease and does not make a consultation to the doctor because of which the diagnosis of the diseases is also delayed and as a consequence its treatment.

On the other hand, older adults or disabled people with a deficiency in urinary sphincter control who use disposable diapers, usually present some associated diseases, such as diabetes, in which case, the identification of glycosuria, represents a concentration of blood glucose elevated and the use of a diaper with a reagent that identifies them in urine this substance would be more useful. The qualitative studies of the urine are the basis of diagnostic guidance to continue with the quantitative studies that are requested according to the pathological case.

On the other hand, qualitative urine studies through a provision of a laboratory technique accessible to the public, encourages the adequate control of the monitoring of different diseases and therefore the need to go to a medical consultation, thus favoring the detection and the timely treatment of some diseases. This is also the basic principle and utility of some other detection methods. chemistry that is already offered to the public, such as pregnancy tests, the AIDS infection detection test in saliva and glucometers.

In the market, reagents are also offered in strips to detect substances such as ketone bodies, which serves to assess the effects of a diet in adults, so that self-monitoring can be done at home, but there are no reagents to date homemade to evaluate the urine of infants placed directly in a disposable reservoir and detect abnormal diseases or health conditions.

On the other hand, as the diaper is also an excrement collector, if reagents that identify reducing substances such as sugars in excrement were additionally included, it would be possible to diagnose sugar intolerance, indicating sugar absorption problems that indirectly confirm a diagnosis of rotavirus diarrhea, or absorption defect problems. Currently, the Clinitest test is used, which is carried out in the office by means of a test strip using the same principle of the reaction of Benedict for urine and / or excrement. Adding said reagent to a diaper would allow monitoring at home of all evacuations of the user of this diaper and its clinical evolution. Just as detecting sugars in the stool is useful for the diagnosis of certain diseases, it is also possible to detect fat and proteins in the stool with the placement of the Sudan Black reagent for fat that is the basis of the Sudan and Biuret test for protein and In the same way, it would help us to diagnose their malabsorption, which suggests different diagnoses where whatever their pathophysiology is, the detection of fat or protein in the stool is useful for making a diagnosis and monitoring.

There is also the need to encourage medical consultations for the timely detection of diseases, since this has an impact on the prevention or early treatment of the same, so the use of a diaper with the reagents mentioned above would alert the user supervisor to indicate the need to go to a doctor or to evaluate in a laboratory the urine or excrement of the minor or of the older adult who uses disposable diaper, in addition said diaper would also be useful to the doctor to monitor possible diseases with the indication of the use of said diaper during the period of the disease with urine or pathological evacuations. A diaper with reagents to detect substances such as metals, would facilitate studies of environmental pollutants such as lead, mercury, etc. or other compounds that pollute the environment and are excreted in the urine, through tests such as that used by Masson's trichromatic dye to detect lead. At present, there are strips of paper or plastic material that contain different reagents attached to detect different substances that occur in abnormal situations in the urine, these strips are immersed in a sample of the specimen of the patient to study and when any substance that is present is present. only it would be in pathological situations, the reagents of the strips by means of chemical processes, change color after seconds or minutes, depending on the substances detected, and the different colors are compared with color graphs containing certain colors corresponding to the presence of various substances. Said test is of a qualitative type and is the guideline for requesting a quantitative test to complement the diagnosis.

The abnormal substances to look for in the urine are leukocytes, these are cells that are not normally found in the urine unless the patient has an infection and their presence is detected when there are more than 5 to 15 cells. Said cells are detected with 0.5% w / w derived from acid thiazoamine ester, 0.4% diazonium salt, and 50% w / w buffer, and the results are not affected with the presence of other cells such as erythrocytes, bacteria or some protozoa (trichomonas) and even when the presence of bilirubins can increase the color of the reaction and the presence of glucose and proteins contribute to decrease the coloration, the result is positive when the reagent tone becomes purple or different shades of lilac. The reagents for detecting nitrites give pink colors, the test of which is based on the principles of the Griess test and uses p-sulfanilic acid and 1.5% ethylenediamine. This test detects the nitrites that are characteristic of Gram negative bacteria and the pink coloration indicates the presence of said bacteria or an infection by bacteria in the urine.

The specific gravity test reflects the amount of ions in the urine, and is carried out by means of bromothymol blue whose greenish-yellow tones are indicative of an increase in ion concentration in

The urine, which, together with the presence of glucose in the urine, can lead to a diagnosis suggestive of diabetes.

The detection of the presence of ketone bodies is based on the principle of the Legal test, which uses sodium nitroprusside that reacts with acetoacetic acid product of the organic metabolism of fat that is excreted in the urine in cases where fats be used by the body as the only source of energy. Positive results indicate states of prolonged fasting, catabolism or destruction of cells or diets that lack protein and carbohydrates. This detection of ketone bodies is also very useful in ketosic or ketogenic diets that are used as treatment in children who have seizures and these diets are the only way to control seizures.

The glucose detection is based on Benedic's tests that detect the presence of reducing substances such as sugars and produces a brown color with the reagents when sugars are present.

This test is very useful for early diagnosis of juvenile or type diabetes

Il in obese patients, as well as monitoring treatments to check their effectiveness. Some contaminants such as lead can also be identified in the urine by means of Masson's trichromatic reagent that produces an orange coloration in the presence of said contaminant.

Although there are laboratory tests that use the same reagents, and are more sensitive, accurate and specific, they use sophisticated devices that can only be used in laboratories and require specialized personnel both for the performance and for the interpretation of the tests. Test strips for home tests are available in self-services, especially for measuring ketones in patients on a dietary regimen or for measuring glucose in urine, etc., in tests for adults. Including in the diapers the reagents mentioned above for diagnosis of urine would be very useful because the same diaper would work as a home alarm that would warn when the patient presents a substance that is not found in common situations in the urine through a control guide, in which the appraiser will compare the colorations given by the different diaper reagents and assess whether there is an abnormally present substance, and will go to the doctor to perform a urine assessment or valuation order by a professional study to treat the disease in a timely manner.

With respect to the diagnosis of excrement, there are test strips to detect reducing substances in excrement for diagnoses of inadequate absorption of sugars. Said test is called Clinitest and is based on the chemical principles of the Benedict reaction to detect reducing substances such as sugars. Likewise there are reagents for fat and for proteins in strips, which are also qualitative tests and are auxiliary for the diagnosis of a bad intestinal absorption of fats and proteins.

Currently, most of the disposable diapers that exist in the market, both for children and for older adults, have the sole purpose of serving as reservoirs of urine and feces, and most of the technological advances that have been developed with respect to them, are related to technical improvements regarding the liquid absorption capacity, as well as the anatomical design.

However, disposable diapers have recently appeared on the market that include means to detect moisture by means of a colored band when it is wet.

A diaper that has these characteristics is described in US Patent No. 5,947,943 to Lee, which includes a moisture indicator material located on the inner side of the back cover which changes from appearance when exposed to moisture. Said material changes from a light color when it is dry to a dark color when it gets wet.

Recently, US Patent No. 6,464,635 of

Jiménez Serrato, claims a diaper with incorporated indicators sensitive to urine to detect pH level, nitrates, bilirubin, acetone, proteins, blood and urobilinogen. However, the Jiménez Serrato patent does not describe or suggest to include indicators for the diagnosis of excrement, nor that the indicators incorporated into the diaper are sensitive to glucose, ketone bodies, sugars, fat, heavy metals such as lead, specific gravity, Clinitest test and viral tests.

In view of the above, the applicant developed a disposable diaper that includes indicators sensitive to urine and excrement to detect glucose, ketone bodies, fat, proteins, heavy metals such as lead, specific gravity and to perform the Clinitest test and viral tests for detect among other viruses rotavirus, adenovirus and echovirus.

The diaper developed by the applicant serves as a control to monitor the urine and feces of the patient in search of substances that are not found in common situations in the urine and feces by means of said indicators, by means of which the appraiser will compare the colorations that give the different diaper indicator reagents and would assess if there is an abnormally present substance. SUMMARY OF THE INVENTION

Therefore, it is a main objective of the present invention to provide a disposable diaper that includes indicators for the diagnosis of urine and excrement.

It is another main objective of the present invention, to provide a disposable diaper of the nature described above, in which the indicators are sensitive to glucose, ketone bodies, proteins, fat, heavy metals such as lead, specific gravity, Clinitest test and tests viral to detect rotavirus, adenovirus and echovirus among other viruses.

It is a further objective of the present invention, to provide a disposable diaper of the nature described above which serves as control to monitor the urine and feces of the patient in search of substances that are not found in common situations in the urine and feces by means of said indicators, by means of which the assessor will compare the colorations given by the different reagents of the diaper indicators and would assess if there is an abnormally present substance

These and other objectives and advantages of the present invention will become apparent to people with normal knowledge in the field of the following detailed description of the invention. DETAILED DESCRIPTION OF THE INVENTION. The invention will now be described with reference to a general embodiment of a disposable diaper, wherein the disposable diaper comprises: an internal absorbent cover; an external water-repellent cover, an absorbent core positioned between the internal and external cover; a lateral fin extending on each side of the absorbent core; a side barrier arranged adjacent to each side end of the article, which may be incorporated directly or indirectly.

In a general embodiment, the invention comprises: a plurality of urine sensitive indicator reagents for detecting: glucose, ketone bodies, heavy metals such as lead, nitrites and specific gravity, fixed to the diaper absorbent inner shell; and a plurality of indicator reagents sensitive to excrement, to detect: fat, proteins and perform Clinitest test and viral tests to detect, among other viruses, the rotavirus, adenovirus and echovirus, fixed to the diaper absorbent inner shell.

In a specific embodiment, the invention comprises: Urine sensitive strip type indicators attached to the diaper absorbent inner shell, each indicator including: a reagent for glucose detection comprising Benedic tests; a reagent for the detection of ketone bodies comprising sodium nitroprusside; a reagent for the detection of heavy metals such as lead comprising Masson's trichromatic; a reagent for the detection of nitrites comprising p-sulfanilic acid and 1.5% ethylenediamine; and a reagent for the detection of specific gravity comprising bromothymol blue; strip type indicators sensitive to excrement, fixed to the internal absorbent diaper cover, each indicator comprising: a reagent for performing the Clinitest test; a reagent for the detection of fat comprising Sudan black; a reagent for the detection of proteins comprising Biuret reagent; a viral test reagent comprising the Rotatest test, which contains rotavirus antibodies;

The strips can be adhered to the inner diaper cover by means of an adherent substance in a suitable position so that they can receive the urine and the excrement.

Although specific indicators were mentioned for each of the tests, it is possible to use any other type of indicators and reagents suitable for the detection of glucose, ketone bodies, heavy metals such as lead, nitrites, specific gravity, fat, proteins and perform a Clinitest test and viral tests to detect any type of virus.

Additionally, any other suitable material can be impregnated with the reagents corresponding to each indicator or impregnated said reagents directly in the fiber of the inner diaper cover.

Finally, it should be understood as so much that the invention is not limited to the modalities discussed above, and that people with average knowledge in the field, may suggest changing the diagnostic diaper of the present invention, derived from the teachings here. described, which will remain within the true spirit and scope of the invention, as claimed in the following claims.

Claims

1. A diagnostic diaper comprising an internal absorbent cover; an external water repellent cover; an absorbent core positioned between the inner and outer shell; a lateral fin extending on each side of the absorbent core; a lateral barrier arranged adjacent to each lateral end of the article, wherein the diaper absorbent inner cover includes: a plurality of urine sensitive indicator reagents to detect: glucose, ketone bodies, heavy metals, nitrites and specific gravity; and a plurality of excrement-sensitive indicator reagents, to detect fat, proteins and perform Clinitest test and viral tests. Pathogens and non-pathogens

2. A diagnostic diaper according to claim 1, wherein the urine sensitive indicator reagents, each comprising: a reagent for glucose detection; a reagent for the detection of ketone bodies; a reagent for the detection of lead; a reagent for nitrite detection; and a reagent for the detection of specific gravity;

3. A diagnostic diaper according to claim 1, wherein the indicator reagents sensitive to excrement each comprising: a Clinitest test reagent; a reagent for the detection of fat; a reagent for protein detection; and a reagent for the detection of rotavirus;

4. A diagnostic diaper according to claim 2, wherein the reagent for glucose detection comprising Benedit tests.

5. A diagnostic diaper according to claim 2, wherein the reagent for the detection of ketone bodies comprising sodium nitroprusside.

6. A diagnostic diaper according to claim 2, wherein the reagent for the detection of lead comprises trichromatic

Masson

7. A diagnostic diaper according to claim 2, wherein the reagent for the detection of nitrites comprising p-sulfanilic acid and 1.5% ethylenediamine.

8. A diagnostic diaper according to claim 2, wherein the reagent for the detection of specific gravity comprising bromothymol blue.

9. A diagnostic diaper according to claim 3, wherein the reagent for the detection of fat comprises Sudan Black.

10. A diagnostic diaper according to claim 3, wherein the reagent for the detection of proteins comprising reagent

Biuret

11. A diagnostic diaper according to claim 3, wherein the reagent for the detection of rotavirus comprises Rotatest.

12. A diagnostic diaper according to claim 1, wherein the viral test reagents can detect rotavirus, adenovirus and echovirus.

13. A diagnostic diaper in accordance with claim 1, wherein the reagents are incorporated into strip type indicators which are adhered to the diaper absorbent inner cover.

14. A diagnostic diaper according to claim 1, wherein the reagents are incorporated directly into the diaper absorbent inner cover.