CH712928B1 - Layer for the selection of biological samples. - Google Patents

Abstract

The invention relates to a diaper designed to facilitate the collection of biological samples and to prevent leakage of secretions and faeces and, after sampling, to prolong its subsequent use for this purpose. The layer consists of at least one absorbent layer of excrement, provided with holes, and a separate absorbent layer.

Description

Technical area

The invention relates to light industry and relates to a layer for the selection of biological samples, which can be used in the context of medical research and diagnosis of human health, based on the analysis of discharging and / or emptying the human body.

Description of the invention

State of the art

Despite the wide range of diagnostic methods and diagnostic equipment, the available and easy-to-use tools for detecting unwanted changes in the body are still very popular. These tools include diagnostic layers that are well known recently, and which are therefore constantly improving to obtain more versatility and functionality.

Biological samples should be considered necessary to analyze the amount of products from vital functions such as urine, stool and any other secretion that can be collected by diapers, for example due to inflammation, d 'bleeding, secretion, etc.

To reduce discomfort and increase the ease of sampling for analysis, hygienic products have appeared, such as layers fitted with analysis tools, such as fillers or inserts, the color and / or the intensity of the reaction with the person's liquid components or feces may vary. These research methods should obviously not completely replace research and analysis in specialized laboratories, but they can be very useful in detecting alterations in the body, especially outside specialized medical establishments. With these diagnostic and hygienic products, we can detect bilirubin, erythrocytes, leukocytes, the presence of nitrites, ketones, proteins, urobilinogen, heavy metals such as lead, mercury, diagnose virus, measure pH, etc. The relative ease of use allows wide use for patient diagnosis without appropriate professional specialization and with a relatively low cost in effort and resources.

The basic structure of the layers is the location of the respective indicators or indicator substances on or in the middle of the layer, so that they make contact with the fluids and / or secretions of the body directly or by moisture dispersion. This performance is achieved by gluing the indicator strips on the outer layer, for the execution of a part with the surface of nonwoven materials, the application by spraying of reagents of layer components, the introduction of these onto the absorbent filler composition.

A similar example is described in the publication of patent application WO 2007 073 139 of 28.06.2007. The layer described includes a plurality of urine indicators and stools which are attached to the absorbent interior substrates and which are used to identify proteins and fats and allow virus testing by comparing the color of various indicators. Said layer is used to detect substances whose content studied in the stool (selection) exceeds the normal limit set.

The publication of American patent application 2002 0 067 275 A1 of 06.06.2002 describes a known layer, the internal layer of which comprises a strip for measuring the pH. With the contact of the strips with the urine, by the change in color of the strips, we can determine the acidity of the urine, thus identifying the infectious processes, including the early stages of development.

In the description of US Pat. No. 5,468,236 A of November 21, 1995, a disposable absorbent product is described which may be a diaper, feminine hygiene, sheets, surgical gowns, etc., comprising the use of several layers of chemically active substances which can change color when in contact with faeces. These substances can be found wherever absorbent disposables can come into contact with feces. In the example illustrated, chemically active substances can be applied by spraying, printing, coating, placing inserts which can be fixed by sliding glue, ultrasonic welding, etc. These reactive compounds can be located on a certain part or dispersed throughout the product.

Disadvantages

All these layers have significant drawbacks, the main of which is their low flexibility. In most cases, the layers mentioned above, for example, the product according to US 2002 0 067 275 equipped with an indicator (s) capable of measuring one or more key indicators, which may not be sufficient to obtain a full picture of the person being tested and causing a need for further diapers or testing in the traditional way. However, layers with a wide range of indicators such as, for example, described in WO 2007 073 139 A and US 5,468,236 A significantly increase their value. Furthermore, not all parameters are measured with the same frequency, but diluting these measurements in the case of layers with a large set of indicators is impossible, since these indicators are used without measurement. In addition to the large number of indicators of various chemicals in the layer, there is a need to rationalize their compliance with a specific product in order to prevent their interaction which could lead to complete unsuitability of the reagents or to the distortion of research results. Unlike diapers, which have a fairly long shelf life, chemical indicators generally have a limited shelf life and require specific storage conditions, reducing the shelf life of products for measurement and making them less attractive to retailers. Note that the presence of various chemical indicators in the composition layer increases the risk of skin irritations and allergic reactions, particularly unacceptable for young children.

The closest analog to the present invention is a layer adjustment for the selection of biological samples, described in patent invention RU No. 250,096 C2 of 04/20/2005. In an alternative embodiment of this closest analog, it is said to contain a moisture absorbing base, a hole for stool passage and an additional separate absorbent layer. The layer described allows for separate selection of urine and faeces using separate absorbent layers. Its major drawback is the need to eliminate a large part of the stool when applying the product in order to reduce the risk of discomfort for the user and, consequently, the product has a structure which is too bulky and complex. The various layers of separate layers are located in it and provide a system of additional layers and a certain order of their location. During filling, the separated layers are manually removed from the layer by a special niche, which is also a major failure given the hygienic aspect of this procedure.

All of the above eliminates the main advantages of the known diaper techniques by which they gained popularity and have become an integral part of childcare and functionally handicapped, namely relative affordability, ease of use, removal speed, hygiene, recycling of diapers, etc.

Technical problem

The present invention describes a layer which allows rapid and efficient sampling. Its use is not limited to a certain type of indicator substance and its constituent structure allows simple, practical and effective use.

Solution

The problem is solved by creating a layer 1 suitable for sampling, comprising a layer for absorbing excrement and the element for absorbing excrement. Thus, according to the invention, at least one dimension of sufficient through hole is provided for the transmission of urine and / or excrement through the absorbent, to a sampling element which consists of a separate absorbent layer 3 , a waterproof layer 4 and a retaining layer 5, hermetically attached to the outside of the layer.

The retaining layer 5 of the sampling element is produced to ensure a tight connection with the outside of the absorption layer of the layer 1 for analysis purposes. The retaining layer 5 of the sampling element has an adhesive internal surface to allow a tight connection with the external side of the layer 1 after separation of the separated absorbent layer 3 for analysis purposes. The separate absorbent 3, waterproof 4 and retaining 5 layers of the sampling element are produced in the form of strips. At least one through hole 2 closed by the sampling element is located at the bottom of the layer 1. In the base of the layer, which absorbs, it is necessary to provide more than one hole 2, preferably 3–4 holes with sufficient dimensions for the passage of stools and / or droppings through absorption bases and these holes are hermetically closed by a sampling element. Layer 1 also comprises at least one sampling element which hermetically closes at least one hole 2 made in the base of the absorbent layer of excrement of layer 1 having a size sufficient for the passage of stool and / or excrement. outside of their absorbent base of layer 1.

Advantages

According to the present invention, it is possible to make a selection of biological samples using the sampling element without removing the layer 1, which performs its basic function. The separable absorbent layer 3 consists of a sampling element used for the analysis of the biological material absorbed by it and which can be analyzed by any measure necessary for a particular case or by any parameter suitable for this method. The analysis is preferably carried out using indicator strips. This method is the most simple and intuitive, does not require specialized training and provides adequate and rapid results.

Thus, layer 1 is designed to facilitate the selection process of biological samples and to prevent leakage or secretions and faeces and, after sampling, to extend its subsequent use for the direct purpose. The contact of the secretions and faeces with the sampling element is obtained by means of localized perforations in predictable places of excrement and / or dejection. It is also possible to carry out multiple sampling sites where it is necessary to carry out a large number of searches or for the possibility of using another separate absorbent layer 3 of sampling element as a control sample for additional analysis tests.

The preferred but not compulsory option is the variant of injections and mixing of the sampling element at the bottom of the layer, since the humidity of the stools and / or of the discharge is uniformly distributed over all the volume of the absorbent layer and the perforation on the back, but reduces the adjustment of interests in pediatric patients. The size of the holes 2 must be sufficient for a slight leakage of stool outside of the layer 1 and is made taking into account the fact that the absorbent layer of the layer 1 during filling can be expanded and block the holes. At the same time, the holes 2 should not be too large to reduce the possibility of direct contact of the separated absorbent layer 3 of the sampling element with the body. Too large a size of the holes 2 is also undesirable due to possible discomfort during the removal of the separated absorbent layer 3 and an additional sealing of the hole 2 with a waterproof and retaining layer 4 5 of the sampling element. For each type of layer 1, the optimal size of the holes is determined individually, depending on the properties used for its manufacture, the materials and the number of layers of layer 1 are usually in the range of 1 to 4 mm. The implementation of a waterproof and retaining layer 4 makes it possible to reliably retain the layer leakage during filling of the separated absorbent layer 3 and to continue to maintain the emptying and / or the selection after having disconnected the separate absorbent layer 3. For a waterproof layer 4, a conventional polymer film can be used and, for the retaining layer 5, a woven material is used to make a medical coating or a polymer material coated with 'an adhesive substance. In this case, a constructive method widely used to seal packages of wet wipes allowing access to multiple internal contents of the package, and maintaining sufficient seal during use, can be applied.

Advantageously, the use of the claimed design of layer 1 allows the user to choose the manner and the means of diagnosis of the human body of its stool and / or its secretions. At the same time, the researcher benefits from the major advantages inherent in the methods of using diagnostic layers, including the uselessness of monitoring the emptying point. When using the proposed layer, the user can select the number of samples required for analysis while respecting the relative cleanliness and hygiene, the capacity to store the layers and the diagnostic means in certain places, according to different storage requirements of the layers and diagnostic means. With the use of all the benefits of diapers, it is possible to use a larger diagnostic set than that offered by traditional diagnostic diaper manufacturers, eliminating the risk of irritant or allergic reactions with the possible contact of tools diagnostic with parts of the body where the amount of possible measurements is not limited only by the amount of material that can be received.

The invention is shown in the drawings.

The drawings

[0020] <tb> Fig. 1 <SEP> The appearance of the layer made with a partial section of the sampling element. <tb> Fig. 2 <SEP> Representation of the sampling process using the layer, according to the invention. <tb> Fig. 3 <SEP> Representation of the process of analysis of biological samples collected by means of layers, according to the invention.

[0021] FIG. 1 represents layer 1. In the defined case, the element which provides a selection of biological sample is placed on the rear bottom of layer 1. Its dimensions are not regulated and are determined on the basis of the quantity required and sufficient biological material to be analyzed. Typically, the length of the absorption strip of 0.5 cm is sufficient to use an indicator strip, as shown in fig. 3 and obtain correct results of the analysis. For each case and type of layer and also the volume of studies to be carried out, one can choose the zone of separate absorbent layer 3 which depends on the total surface of the sampling element according to the situation. For children's diapers the sizes may be a little less clear due to the size of the diaper and all the material products. For adult diapers the length of the belt can vary within a wider range, depending on the tasks and the need. Taking into account that in most cases there is a feasibility analysis on several indicators, a separate absorbent layer 3 of size 5 × 2 cm is sufficient to obtain a sufficient quantity of material for research.

[0022] FIG. 1 shows holes of preferential location 2, for the passage of biological samples outside of layer 1. Their optimal number is 3–4. The size of the holes designed primarily to transmit urine or stool moisture can be slightly enlarged to allow passage of feces which can be partially adhered to the separated absorbent layer 3 and can then be used for analysis by testing tools or directed to laboratory research. The holes released in this case are not likely to cause a flow of urine after removing the separated absorbent layer 3, because the excess liquid is retained in the holes 2 or around them and is absorbed slowly by the absorbent layer primary of layer 1. A separate absorbent layer 3 is arranged within the boundaries of the holes 2. The main requirement for the separated absorbent layer 3 is the rapid collection of sufficient liquid. The material of the separated absorbent layer 3 must be chemically inert towards the components of urine and of possible unconventional components, the appearance of which is caused by changes in the body. For the most part, ordinary cotton material is suitable for a specific use. The separate absorbent layer 3 can be produced in the form of a strip of nonwoven material, of fabric, whichever is best in the particular case of the properties of the strip. To eliminate the additional spread of moisture from the separated absorbent layer 3, a waterproof layer 4 should be applied to it. This layer is made of any medically acceptable material, in which the waterproof properties are inherent. The separated absorbent layer 3 and the waterproof layer 4 are placed in this order on the outside of the layer 1, affixed to the holes 2 and are fixed to the latter by gluing the retaining layer 5 using preferably an adhesive tape whose dimensions are larger than the previous layers. Due to this arrangement, the waterproof layer 4 seems to be stuck completely to the adhesive tape 5 and because the adhesive strips are larger than the previous layers, it forms a waterproof connection outside the bases of the layer and of the waterproof bag in which a separate absorbent layer 3 is placed and after filling can be removed from the bag without any problem as shown, for example, in FIG. 2. The adhesive tape 5 consists of a sticky coating which can retain its adhesive properties after opening the pockets and removing the separated absorbent layer 3. Consequently, the holes 2, which retain their property of passing stools, will be blocked by pressing them. with waterproof tape 4 with adhesive tape 5. Over time, the holes in the diaper will be blocked due to swelling of the absorbent material of the absorption base thereby minimizing the risk of treatment and / or discharge to the outside when the layer is filled. This feature allows the layer resource to be used appropriately after the necessary biological sample has been selected. The layer is thus used as follows.

The person examined in the time recommended for the collection of biological samples must wear a diaper made according to the invention. With a certain frequency layer 1 or the selection element must be checked on the fact of receiving biological samples. Preferably, in the case of a selection of biological samples on urine, stool moisture or directly on faeces, observation requires the immediate opening of the sampling element, because the determination of 'A sufficient amount for sampling can be done by visual analysis of the diaper by touch, smell.

If it is necessary to look for other secretions caused by inflammation, secretion or blood loss from the body, periodic observation of the filling of the separated absorbent layer 3 may be necessary if the stools are not as intense than those caused by natural needs. After the filling of the separated absorbent layer 3 is deemed sufficient for the study of the quantity of the material, the retaining layer 5 is partially separated by hand from the surface of the outer layer of layer 1 until the space thus formed allows the separate absorbent layer 3 to be removed from its pocket. This layer with all the rules of research must be removed using specialized tools such as pliers, hook or manually using disposable gloves or other suitable method for this which will provide the required purity. After selection of the biological samples, this can be studied by any known technical method. Due to the use of the current diaper at home as a simple tool for this purpose, the diagnostic procedure is applied using the devices for test strips or specific test reagents. It is possible to use a standardized plate and a set of indicators. The order of studies can be more intuitive based on the image shown in fig. 2 and fig. 3. An absorbent layer separated 3 after its separation from layer 1 is applied alternately to the pads located on the tablet. Each pad can be used with a new absorption band to minimize the analysis error. Body condition should be determined by color change indicators and standard colors attached to the instructions for use. Based on the results of the analysis, a decision should be made regarding additional measures for treatment or prevention or the possibility of returning to a normal healthy lifestyle.

Inventions of the invention

1. For the research we chose a diaper for children of the largest child size, labeled by manufacturers to users 16 + kg. In the lower part, perforations were made in 3 for which an acute rod 2 mm in diameter was used. Opposite the holes on the outside of the layer, a cotton strip with a thickness of around 3 mm was imposed, from the top of which a layer of plastic was placed and the laminated structure was fixed. to layer 1 using a medical patch larger than the size of the previous layers. To investigate the practical life of the product, a whole single urine sample of the individual weighing approximately 16 kg was chosen on standard procedures in a specialized container. The sample volume selected was approximately 100 ml. A few selected samples were placed in a pipette, the urine was dropped on the test strip designed to determine the pH. The rest of the urine is poured completely inside the diaper made according to the invention. By disconnecting the upper layer of plaster observations on the seepage of urine infiltration was made.

During the check in 1 minute by visual and tactile characteristics, it was determined that the urine leaked towards the separated absorbent layer 3 through the main layers of the layer 1. This layer was separated from the formed layer by the space between the retaining layer 5 and the separated absorbent layer 3 was removed by hand and applied to test strips for pH, similar to those with which the test was carried out by pipetting. The moisture absorbed by the strip was sufficient to change the color of the test strip applied to the absorption strips and the test strips relative to each other.

The comparison of the results of the tests carried out by drop by drop directly on the test strip and using samples taken by means of layers showed similar results, which confirmed the relevance of the proposed invention. for the selection of biological samples and the ability to use them for diagnostic purposes. The practical use of the diaper design directly on the child has proven its reliability with regard to leaks, the filling process and after removal of the absorption strips from the pouch holding it. The baby has not shown any implications as to the inconvenience or discomfort of wearing such a diaper. Thus, it has been fully confirmed by the practical relevance of the proposed layer for selecting biological samples while preserving their basic functions.

The invention is not limited to the illustrated embodiment and can be used in other specific forms without losing the overall trends and essential attributes. Consequently, the embodiment described must be considered in all respects only as illustrative and not as limiting the scope of the invention. Any modification proposed as equivalent to the invention must be considered to be included in the present invention.

2. Laboratory studies were also carried out to check the performance capacity of the layers under laboratory conditions. The diapers and test strips with sensitive areas were used for the use of colorimetric analysis to determine glucose, pH, ketone bodies. The analysis results obtained using the layers were compared with those obtained with the traditional laboratory study. Tests were performed at an interval of 4 hours. The results of the diaper studies were 100% laboratory results. Layers can be used to determine glucose, pH, ketones in the urine.

Claims (5)

1. Layer (1) suitable for taking biological samples consisting of at least one excrement absorption layer and a separate absorbent layer (3) characterized in that it comprises: - at least one through hole (2), at the bottom of the layer (1), being in the excrement absorption layer, said at least one through hole (2) having dimensions sufficient to allow the transmission of stools and / or urine through the excrement absorption layer; - a sampling element composed of the separate absorbent layer (3), a waterproof layer (4) and a retaining layer (5); said sampling element being fixed on the outside of the layer (1) so as to close said at least one through hole (2) and ensure a tight connection with the external part of the layer (1). 2. Layer according to claim 1, characterized in that the sampling element is arranged so as to allow, after separation of the separated absorbent layer (3) for analysis purposes, the reconfiguration of the impermeable layer water (4) and the retaining layer (5) to ensure a tight connection with the outer part of the layer (1). 3. Layer according to claims 1 or 2, characterized in that the retaining layer (5) has an internal adhesive surface to allow the realization of the tight connection with the outer part of the layer (1) after separation of the absorbent layer separate (3) for analysis purposes. 4. Layer according to one of the preceding claims, characterized in that the separate absorbent layer (3), the waterproof layer (4) and the retaining layer (5) of the sampling element are present. in the form of bands. 5. Layer according to one of the preceding claims, characterized in that the base of the excrement absorption layer comprises 3 or 4 holes with dimensions sufficient to allow stool and / or urine to pass through the base of the excrement absorption layer, said 3 or 4 holes being hermetically closed by at least one component of the sampling element.