ES2649029B1 - SYSTEM FOR SELF-COLLECTION OF SAMPLES AND ASSOCIATED PROCEDURE - Google Patents
SYSTEM FOR SELF-COLLECTION OF SAMPLES AND ASSOCIATED PROCEDURE Download PDFInfo
- Publication number
- ES2649029B1 ES2649029B1 ES201630932A ES201630932A ES2649029B1 ES 2649029 B1 ES2649029 B1 ES 2649029B1 ES 201630932 A ES201630932 A ES 201630932A ES 201630932 A ES201630932 A ES 201630932A ES 2649029 B1 ES2649029 B1 ES 2649029B1
- Authority
- ES
- Spain
- Prior art keywords
- self
- collection
- samples
- cannula
- sample
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M1/00—Apparatus for enzymology or microbiology
- C12M1/26—Inoculator or sampler
Landscapes
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Health & Medical Sciences (AREA)
- Wood Science & Technology (AREA)
- Biotechnology (AREA)
- Organic Chemistry (AREA)
- Zoology (AREA)
- Microbiology (AREA)
- Sustainable Development (AREA)
- Biomedical Technology (AREA)
- Biochemistry (AREA)
- General Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Medicinal Chemistry (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Sampling And Sample Adjustment (AREA)
Abstract
Sistema para la auto-recogida de muestras y procedimiento asociado en el que el sistema está conformado por un determinado estuche, un instrumento de auto-recogida de muestras y una unidad de material secante y absorbente de transferencia de muestras. De tal manera que el procedimiento asociado se inicia con la auto-toma de una muestra biológica mediante el citado instrumento de auto-recogida, a continuación los restos biológicos extraídos son depositados convenientemente en una unidad de material secante, la cual se introduce en un habitáculo habilitado en el citado estuche. Posteriormente este estuche se aloja en un definido paquete, que transporta la muestra hasta el departamento de análisis oportuno, en el cual analizan los restos depositados en la unidad de material secante y devuelven los resultados de las pruebas realizadas al tomador de la muestra.System for the self-collection of samples and associated procedure in which the system is made up of a specific case, an instrument for the self-collection of samples and a unit of drying and absorbent material for transferring samples. In such a way that the associated procedure is initiated with the self-taking of a biological sample by means of said self-collection instrument, then the extracted biological remains are conveniently deposited in a unit of drying material, which is introduced into a cabin enabled in the mentioned case. Subsequently, this case is housed in a defined package, which transports the sample to the appropriate analysis department, in which they analyze the remains deposited in the drying material unit and return the results of the tests performed to the sample taker.
Description
55
1010
15fifteen
20twenty
2525
3030
SISTEMA PARA LA AUTO-RECOGIDA DE MUESTRAS Y PROCEDIMIENTO ASOCIADOSYSTEM FOR SELF-COLLECTION OF SAMPLES AND ASSOCIATED PROCEDURE
DESCRIPCIONDESCRIPTION
Sistema para la auto-recogida de muestras y procedimiento asociado.System for the self-collection of samples and associated procedure.
OBJETO DEL INVENTOOBJECT OF THE INVENTION
El invento esta pensado para que una persona pueda coger por si misma cualquier muestra biologica procedente de su propio cuerpo tal que celulas epiteliales procedentes de la boca, fosas nasales, cuello uterino, uretra o cavidad anorectal, por medio de un sistema o conjunto de elementos adaptados en cada caso para la auto-recogida de muestras, con el objeto de la detection e identification del propio ADN o de posibles agentes vmcos o microbianos infecciosos mediate un procedimiento asociado por el cual una vez tomada la muestra se transporta, examina y devuelven los resultados al tomador de la muestra.The invention is designed so that a person can take on their own any biological sample from their own body such that epithelial cells from the mouth, nostrils, cervix, urethra or anorectal cavity, through a system or set of elements adapted in each case for the self-collection of samples, in order to detect and identify the DNA itself or possible infectious microbial or microbial agents through an associated procedure by which once the sample is taken it is transported, examined and returned. results to the sample taker.
El invento esta integrado por un sistema conformado por un determinado estuche, un instrumento de auto-recogida de muestras y una unidad de material secante y absorbente y unidad para la transferencia y transporte de muestras. De tal manera que el procedimiento asociado al referido sistema, se inicia con la auto-toma de una muestra biologica mediante el instrumento de auto-recogida mencionado, a continuation los restos biologicos extraidos son depositados convenientemente en el soporte que permite el transporte de las muestras, la cual se introduce en un habitaculo habilitado en el citado estuche. Posteriormente este estuche se aloja en un definido paquete, que transporta la muestra hasta el departamento de analisis oportuno, en el cual analizan los restos depositados en la unidad de material secante y devuelven los resultados de las pruebas realizadas al tomador de la muestra.The invention is made up of a system consisting of a specific case, a sample self-collection instrument and a unit of drying and absorbent material and unit for the transfer and transport of samples. In such a way that the procedure associated with the said system, starts with the self-taking of a biological sample by means of the mentioned self-collection instrument, then the extracted biological remains are conveniently deposited in the support that allows the transport of the samples , which is introduced in a room enabled in the aforementioned case. Subsequently, this case is housed in a defined package, which transports the sample to the appropriate analysis department, in which they analyze the remains deposited in the drying material unit and return the results of the tests performed to the sample taker.
55
1010
15fifteen
20twenty
2525
3030
El campo de aplicacion de la invention se encuentra comprendido dentro del sector de la auto-toma de muestras para el estudio genetico individual y la detection sistematica de agentes patogenos para el efectivo control de la salud.The field of application of the invention is comprised within the sector of self-sampling for the individual genetic study and the systematic detection of pathogenic agents for effective health control.
ANTECEDENTES DE LA INVENCIONBACKGROUND OF THE INVENTION
A lo largo de los ultimos anos el desarrollo tecnologico y la investigation biomedica ha producido espectaculares avances en el campo de la salud. Es por ello que, en la actualidad hay un numero creciente de empresas que ofrecen servicios de pruebas basadas en tecnicas geneticas y moleculares, como son las pruebas de diagnostico que indican una predisposition a los trastornos comunes, las pruebas de perfiles de riesgo a la adiccion, las pruebas nutrigenomicas, la farmacogenomica y las pruebas de identification personal o de ascendencia.Over the last few years, technological development and biomedical research has produced spectacular advances in the field of health. That is why, at present there is an increasing number of companies that offer testing services based on genetic and molecular techniques, such as diagnostic tests that indicate a predisposition to common disorders, tests of risk profiles to addiction. , nutrigenomic tests, pharmacogenomics and personal identification or ancestry tests.
Por otro lado, las enfermedades de transmision sexual producidas por bacterias o virus como el papillomavirus son controladas mediante los programas de prevention del cancer cervical. En todos estos casos los programas o procesos de toma de muestras para la deteccion y estudio de restos biologicos, son realizados por personal cualificado y formado para tal fin, igualmente la rapidez de la deteccion de los mismos es fundamental para un correcto y efectivo tratamiento. Es por ello que hay multitud de estudios estadisticos realizados con el fin de comprobar que mecanismos rapidos y eficientes podrian ayudar a conseguir un diagnostico fiable y a la vez eficiente en comodidad como es el caso de las auto- tomas, para que llegue al mayor numero de personas posibles.On the other hand, sexually transmitted diseases caused by bacteria or viruses such as papillomavirus are controlled by cervical cancer prevention programs. In all these cases, the sampling programs or processes for the detection and study of biological remains are carried out by qualified personnel trained for this purpose, and the speed of their detection is also essential for a correct and effective treatment. That is why there are many statistical studies carried out in order to verify that fast and efficient mechanisms could help to obtain a reliable diagnosis and at the same time efficient in comfort as is the case of the cars, so that it reaches the greatest number of possible people.
Las dudas iniciales que surgieron a este respecto fueron sobre la calidad de la muestra obtenida por la interesada, frente a la calidad de la muestra obtenida por el personal sanitario debidamente entrenado, pero numerosos estudios cientificos avalaron que dicha calidad es similar en ambos escenarios y la importancia radica en las condiciones de manipulation de la toma de la muestra, la conservation y el transporte de la misma.The initial doubts that arose in this regard were about the quality of the sample obtained by the interested party, compared to the quality of the sample obtained by duly trained health personnel, but numerous scientific studies endorsed that this quality is similar in both scenarios and Importance lies in the conditions of manipulation of the sampling, conservation and transport of the sample.
55
1010
15fifteen
20twenty
2525
3030
Tras hacer un estudio del estado de la tecnica a este respecto, se ha encontrado diferentes registros entre los cuales hemos destacado el registro de Patente ES2227864T3 titulado “Dispositivo para la recogida y examen de muestras” y el registro de Patente ES2273715T3 titulado “Aparato para obtener muestras biologicas”. En ambos casos se presenta un dispositivo o aparato destinado a la recogida e inspection de muestras biologicas para su posterior estudio, pero en estos dispositivos o aparatos quien toma la muestra biologica es un medico o profesional formado, mientras que con el dispositivo para la auto-recogida de muestras objeto del presente invento, el tomador de la muestra biologica es la propia persona que desea hacerse la muestra. As! pues, el inconveniente de muchas personas que por motivos personales o laborales no tienen tiempo o medios para desplazarse a un centro medico, desaparece, ya que pueden realizarse las necesarias pruebas periodicas o puntuales de estudio, de manera comoda y eficiente consecuencia ademas del procedimiento asociado desde la toma hasta la information de los resultados derivados.After doing a study of the state of the art in this regard, different records have been found among which we have highlighted the patent registration ES2227864T3 entitled "Device for collecting and examining samples" and the patent registration ES2273715T3 entitled "Apparatus for obtaining biological samples". In both cases, a device or device is presented for the collection and inspection of biological samples for later study, but in these devices or devices the person who takes the biological sample is a trained doctor or professional, while with the device for self-examination. Collection of samples object of the present invention, the biological sample taker is the person who wishes to make the sample. Ace! therefore, the inconvenience of many people who for personal or work reasons do not have time or means to move to a medical center, disappears, since the necessary periodic or specific tests of study can be carried out, in a comfortable and efficient way in addition to the associated procedure from the taking to the information of the derived results.
Por otro lado, tambien destacamos el registro ES2568434T3 titulado “Sistema de muestreo” por considerar mas proximo al estado de la tecnica. En este caso el muestreo se realiza mediante un instrumento o dispositivo que permite la toma de la muestra biologica a la propia persona , este instrumento esta constituido a groso modo por un eje flexible que tiene un mango en un extremo y que se compone por unas protuberancias y unas ranuras en donde se deposita la muestra ginecologica. Es por ello que este registro es totalmente diferente al dispositivo para la auto- recogida de muestras y procedimiento asociado objeto del presente invento, puesto que con el dispositivo del invento las muestras biologicas son primero recogidas mediante un elemento de material esteril adhesivo y/o exfoliante dependiendo del tipo de muestra a recoger, y luego transferidas a una determinada unidad secante, que protege la integridad de los acidos nucleicos depositados, siendo inexistente en el objeto del invento tanto la existencia de protuberancias y ranuras para el deposito de la muestra biologica, como la existencia de un ejeOn the other hand, we also highlight the ES2568434T3 register entitled “Sampling system” because it is considered closer to the state of the art. In this case the sampling is carried out by means of an instrument or device that allows the person to take the biological sample, this instrument is roughly constituted by a flexible axis that has a handle at one end and that is composed of protrusions and some grooves where the gynecological sample is deposited. That is why this record is totally different from the device for the self-collection of samples and associated procedure object of the present invention, since with the device of the invention the biological samples are first collected by means of an element of sterile adhesive and / or exfoliating material. depending on the type of sample to be collected, and then transferred to a specific drying unit, which protects the integrity of the deposited nucleic acids, the existence of bumps and grooves for the deposit of the biological sample, as well as the object of the invention being nonexistent. the existence of an axis
55
1010
15fifteen
20twenty
2525
3030
flexible con una dimension tal que sea necesario el uso de un mango en un extremo, entre otros.flexible with a dimension such that it is necessary to use a handle at one end, among others.
Es por todo ello, que con el sistema para la auto-recogida de muestras y procedimiento asociado objeto del presente invento, se va un paso mas alla en el campo de la auto-toma de muestras para la identificacion individual y la deteccion sistematica de agentes patogenos, puesto que presenta un sistema capaz de tomar distintos tipos de muestras biologicas de forma sencilla y eficaz, ademas de indolora para la persona que lo utiliza, con una calidad y caracteristicas distintas a lo conocido en la actualidad.It is for all this, that with the system for the self-collection of samples and associated procedure object of the present invention, a further step is taken in the field of self-sampling for the individual identification and systematic detection of agents pathogens, since it presents a system capable of taking different types of biological samples in a simple and effective way, in addition to painless for the person who uses it, with a quality and characteristics different from what is known today.
A continuacion, se realiza una detallada descripcion del invento que completa estas ideas generales introducidas en este punto.Next, a detailed description of the invention is completed that completes these general ideas introduced at this point.
DESCRIPCION DEL INVENTODESCRIPTION OF THE INVENTION
El sistema del invento esta conformado por un determinado estuche, un instrumento de auto-recogida de muestras y una unidad de transferencia de muestras. De tal manera que el procedimiento asociado se inicia con la auto-toma de una muestra biologica mediante el citado instrumento de auto-recogida, a continuacion los restos biologicos extraidos son depositados convenientemente en una unidad de material secante, la cual se introduce en un habitaculo habilitado en el citado estuche. Posteriormente este estuche se aloja en un definido paquete, que transporta la muestra hasta el departamento de analisis oportuno, en el cual analizan los restos depositados en la unidad de material secante y devuelven los resultados de las pruebas realizadas al tomador de la muestra, como veremos a continuacion.The system of the invention is made up of a specific case, a sample self-collection instrument and a sample transfer unit. In such a way that the associated procedure begins with the self-taking of a biological sample by means of the aforementioned self-collection instrument, then the extracted biological remains are conveniently deposited in a unit of drying material, which is introduced into a room enabled in the mentioned case. Subsequently, this case is housed in a defined package, which transports the sample to the appropriate analysis department, in which they analyze the remains deposited in the drying material unit and return the results of the tests performed to the sample taker, as we will see then.
El instrumento de auto-recogida de muestras se encuentra en el interior de un estuche, que lo contiene convenientemente ajustado mediante apriete o similar en su contorno para que el citado instrumento o elemento no sufra ningun tipo deThe sample self-collection instrument is located inside a case, which contains it conveniently adjusted by tightening or similar in its contour so that said instrument or element does not suffer any type of
55
1010
15fifteen
20twenty
2525
3030
movimiento dentro del mismo, estando de este modo inamovible. El citado instrumento de auto-recogida se conforma por una canula o tubo corto hueco en cuyo interior hay un embolo que contiene un bastoncillo rematado por material esteril adhesivo y/o exfoliante con el cual se recogen debidamente las diferentes muestras.movement within it, thus being immovable. The aforementioned self-collection instrument is formed by a hollow cannula or short tube inside which there is a plunger that contains a stick topped by sterile adhesive and / or exfoliating material with which the different samples are properly collected.
Los tipos de muestras biologicas que una persona puede realizarse as! misma con el sistema objeto del invento y procedimiento asociado, son muestras procedentes de la boca, garganta, nariz, parpados, muestras de ano, recto, vagina, cuello uterino y pene.The types of biological samples that a person can perform as well! same with the system object of the invention and associated procedure, are samples from the mouth, throat, nose, eyelids, samples of anus, rectum, vagina, cervix and penis.
Es por ello que el instrumento de auto-recogida que constituye el sistema, puede adquirir distintas configuraciones para facilitar la recogida de las distintas muestras, dependiendo de la zona y agentes patogenos a analizar; siendo las configuraciones preferentes de este instrumento de auto-recogida la denominada como bastoncillo y la denominada convexa, senalando que la configuracion convexa puede tener un orificio o cavidad central en su extremo para la adecuada salida y posterior entrada de un Hquido en su interior.That is why the self-collection instrument that constitutes the system can acquire different configurations to facilitate the collection of the different samples, depending on the area and pathogens to be analyzed; the preferred configurations of this self-collecting instrument being the so-called swab and the so-called convex, indicating that the convex configuration may have a hole or central cavity at its end for the adequate exit and subsequent entry of a liquid inside.
Como se ha citado previamente, este instrumento de auto-recogida se constituye por una canula que, en el caso de la denominada configuracion en bastoncillo, tiene sus dos planos extremos abiertos y en el caso de la configuracion convexa, uno de los extremo posee una superficie curvada hacia fuera y el otro extremo se encuentra preferentemente cerrado.As previously mentioned, this self-collection instrument is constituted by a cannula that, in the case of the so-called stick configuration, has its two open end planes and in the case of the convex configuration, one of the ends has a surface curved out and the other end is preferably closed.
Concretamente en la configuracion de bastoncillo, en el interior de la citada canula hay un elemento de recogida de la muestra, como es el caso de un bastoncillo de material esterilizado y una adecuada longitud, que esta ubicado en su interior de tal manera que este bastoncillo se desplaza longitudinalmente evitando manipulaciones indebidas. En uno de los extremos que posee el citado bastoncillo, se recoge la muestra mediante friccion con movimientos verticales, deSpecifically in the configuration of the swab, inside the said cannula there is a sample collection element, such as a swab of sterilized material and a suitable length, which is located inside such that this swab it moves longitudinally avoiding undue manipulation. In one of the ends that the aforementioned stick has, the sample is collected by friction with vertical movements, of
55
1010
15fifteen
20twenty
2525
3030
rotation axial o vibration. De esa manera a traves de las cerdas de material esteril a modo de cepillo, torunda, material exfoliante, adhesivo o similar se impregna de material biologico.axial rotation or vibration. Thus, through the bristles of sterile material as a brush, swab, exfoliating material, adhesive or the like, it is impregnated with biological material.
Se hace notar que las cerdas indicadas solidarias al movimiento del denominado bastoncillo puede ser manual, a traves de un elemento perpendicular al bastoncillo o travesano el cual se encuentra fijado en el extremo contrario a la toma de la muestra y posibilita la extraction y movimiento de las cerdas de material esteril sobre la zona de obtencion de la muestra; o mecanico, a traves de un motor electrico o electronico ubicado en el interior de la canula y que transmite el citado movimiento de friction al bastoncillo mecanicamente por un eje regulable por un dispositivo reductor de revoluciones.It is noted that the bristles indicated in solidarity with the movement of the so-called swab can be manual, through an element perpendicular to the swab or crossbar which is fixed at the opposite end of the sample and allows the extraction and movement of the bristles of sterile material over the sample collection area; or mechanically, through an electric or electronic motor located inside the cannula and that transmits the aforementioned movement of friction to the stick mechanically by an axis adjustable by a speed reducing device.
De manera analoga, con la configuration convexa del instrumento de auto- recogida, se toma la muestra de material biologico tambien mediante friccion a traves del citado material esteril, preferentemente de material exfoliante y/o adhesivo, que se encuentra ubicado sobre la superficie curvada hacia fuera o convexa de la canula o similar, es decir, en este caso la zona de impregnacion de material biologico se ubica sobre la superficie exterior del tubo corto o canula. De esta manera la impregnacion de la muestra se obtiene sobre el material esteril tambien por movimientos verticales, de rotacion axial o vibracion, pero sobre la superficie exterior de material esteril de la misma. Esta action tambien puede ser manual o mecanica.Similarly, with the convex configuration of the self-collection instrument, the sample of biological material is also taken by friction through said sterile material, preferably exfoliating and / or adhesive material, which is located on the curved surface towards outside or convex of the cannula or similar, that is, in this case the zone of impregnation of biological material is located on the outer surface of the short or cannula tube. In this way the impregnation of the sample is obtained on the sterile material also by vertical movements, axial rotation or vibration, but on the outer surface of sterile material thereof. This action can also be manual or mechanical.
Como se ha indicado anteriormente, la configuracion convexa del instrumento de auto-recogida de material biologico admite un orificio o cavidad central en su extremo. En esta configuracion, la canula recoge el material biologico en su superficie interior, es decir, en el interior de la canula o tubo corto se extrae mediante la presion de un embolo a traves del citado resquicio central, de tal manera que la zona o cavidad corporal de la que se obtiene la muestra biologica, se llena del citado Hquido para posteriormente ser recogido nuevamente al interiorAs indicated above, the convex configuration of the biological material self-collection instrument admits a hole or central cavity at its end. In this configuration, the cannula collects the biological material on its inner surface, that is, inside the cannula or short tube, it is extracted by pressing a plunger through the aforementioned central gap, such that the area or cavity body from which the biological sample is obtained, it is filled with the aforementioned liquid to be later collected again inside
55
1010
15fifteen
20twenty
2525
3030
de la canula, una vez que el Hquido esteril se ha impregnado de restos biologicos. Esta introduction al interior de la canula, se realiza manualmente por la action de un muelle o resorte situado entre el embolo y una de las caras extremas de la canula que se encuentra cerrada.of the cannula, once the sterile liquid has been impregnated with biological remains. This introduction inside the cannula is done manually by the action of a spring or spring located between the plunger and one of the end faces of the cannula that is closed.
Una vez descrito el sistema para la auto-recogida de muestras biologicas y conjunto de elementos que lo conforman, es necesario definir los distintos pasos que integran el procedimiento asociado para su correcto uso.Once the system for the self-collection of biological samples and the set of elements that make it up is described, it is necessary to define the different steps that make up the associated procedure for its correct use.
Como se ha citado previamente el procedimiento asociado se inicia con la auto- toma de una muestra biologica mediante el instrumento de auto-recogida, segun la zona del cuerpo que sea objeto del analisis. Esta recogida se realiza mediante el frotis o friction del material esteril talque cerdas a modo de cepillo, torunda, material exfoliante, adhesivo o similar sobre la zona que es susceptible a la obtencion de la muestra. Una vez que el material biologico es recogido por el citado material esteril, independientemente de la configuration del instrumento de auto-recogida, los restos biologicos extraidos se depositan convenientemente en una unidad de material secante y absorbente. Esta unidad que protege la integridad de los acidos nucleicos contenidos en la misma, se introduce en un habitaculo habilitado en el estuche citado previamente que forma parte del sistema del invento.As previously mentioned, the associated procedure begins with the self-taking of a biological sample by means of the self-collection instrument, according to the area of the body that is the object of the analysis. This collection is carried out by means of the smear or friction of the sterile material such as brush bristles, swabs, exfoliating, adhesive or similar material on the area that is susceptible to obtaining the sample. Once the biological material is collected by said sterile material, regardless of the configuration of the self-collection instrument, the extracted biological remains are conveniently deposited in a unit of drying and absorbent material. This unit that protects the integrity of the nucleic acids contained therein, is introduced into a room enabled in the aforementioned case that is part of the system of the invention.
Otro detalle del invento es que la referida unidad de material secante, debido a su configuracion y particularidades, permite la manipulacion y transporte de una muestra potencialmente infecciosa, reduciendo los riesgos para la salud de las personas que deben manejarla.Another detail of the invention is that the said unit of drying material, due to its configuration and particularities, allows the manipulation and transport of a potentially infectious sample, reducing the health risks of the people who must handle it.
A continuation, este estuche con la unidad de material secante y absorbente en su interior, es alojado en el interior de un definido paquete de transporte. Este paquete contiene impreso sobre su superficie la direction de envio del centro de analisis, departamento de analisis o similar, y ademas una identification unicaThen, this case with the unit of drying and absorbent material inside, is housed inside a defined transport package. This package contains printed on its surface the shipping address of the analysis center, analysis department or similar, and also a unique identification
55
1010
15fifteen
20twenty
2525
talque un codigo alfanumerico, codigo de barras o semejante de tal manera que el tomador de la muestra posee un codigo unico con cada sistema de auto-recogida utilizado.Park an alphanumeric code, bar code or similar in such a way that the sample holder has a unique code with each auto-collection system used.
Finalmente, tras el transporte del paquete de envfo en su conjunto, los restos biologicos depositados en la unidad de material secante son analizados para obtener el perfil genetico individual o para la identification de agentes patogenos contenidos en ella o para su utilization en el genotipado del propio tomador. Posteriormente los resultados obtenidos son devueltos al tomador de la muestra, que inicialmente se ha registrado en un determinado portal web con sus datos y la identificacion unica de su sistema de auto-recogida. Es por ello que los resultados de las pruebas realizadas se hacen llegar al tomador mediante correo postal y/o a traves del citado portal web.Finally, after transporting the shipping package as a whole, the biological remains deposited in the drying material unit are analyzed to obtain the individual genetic profile or for the identification of pathogenic agents contained in it or for its use in the genotyping of the same. taker Subsequently, the results obtained are returned to the sample taker, who has initially registered in a certain web portal with their data and the unique identification of their self-collection system. That is why the results of the tests carried out are sent to the policyholder by postal mail and / or through the aforementioned web portal.
Para completar la description que se esta realizando y con objeto de ayudar a una mejor comprension de las caracteristicas del invento, se acompana como parte integrante de la misma un juego de dibujos en donde con caracter ilustrativo y no limitativo se ha representado lo siguiente:To complete the description that is being carried out and in order to help a better understanding of the characteristics of the invention, a set of drawings is attached as an integral part of it, where the following has been represented by way of illustration and not limitation:
La figura 1 es una representation del conjunto del sistema para la auto-recogida objeto del invento.Figure 1 is a representation of the system set for the self-collection object of the invention.
La figura 2 es una representacion del instrumento de auto-recogida de muestras de la figura 1, en su configuracion de bastoncillo de uso manual, cuando este se encuentra protegido en el interior de la canula.Figure 2 is a representation of the sample self-collection instrument of Figure 1, in its configuration of a hand swab, when it is protected inside the cannula.
La figura 3 es una representacion de la figura 2 con el bastoncillo saliendo por un extremo de la canula en la position de recogida de la muestra biologica.Figure 3 is a representation of Figure 2 with the stick coming out of one end of the cannula in the position of collecting the biological sample.
55
1010
15fifteen
20twenty
2525
3030
La figura 4 es una representacion del instrumento de auto-recogida de muestras de la figura 1, en su configuracion de bastoncillo de uso mecanico en la position de recogida de la muestra biologica.Figure 4 is a representation of the sample self-collection instrument of Figure 1, in its configuration of a stick for mechanical use in the position of collection of the biological sample.
La figura 5 es una representacion del instrumento de auto-recogida de muestras de la figura 1, en una configuracion convexa.Figure 5 is a representation of the sample self-collection instrument of Figure 1, in a convex configuration.
La figura 6 es una representacion del instrumento de auto-recogida de muestras de la figura 1, en una configuracion convexa con orificio o cavidad central en su extremo de extraction y recogida de un Hquido esteril en su interior.Figure 6 is a representation of the sample self-collection instrument of Figure 1, in a convex configuration with a hole or central cavity at its extraction end and collecting a sterile liquid inside.
La figura 7 es una representacion de un paquete donde se introduce el estuche con la muestra biologica recogida por el sistema del invento.Figure 7 is a representation of a package where the case with the biological sample collected by the system of the invention is introduced.
La figura 8 es una ilustracion del modo de empleo adecuado para utilizar el sistema de auto-recogida de muestras y procedimiento asociado del invento.Figure 8 is an illustration of the mode of use suitable for using the sample self-collection system and associated method of the invention.
DESCRIPCION DE LOS DIBUJOSDESCRIPTION OF THE DRAWINGS
El sistema del invento esta conformado por un determinado estuche (1), un instrumento de auto-recogida de muestras (2) y una unidad de material secante (3) y absorbente para el transporte de muestras (Fig.1).The system of the invention is made up of a specific case (1), a sample self-collection instrument (2) and a unit of drying material (3) and absorbent for the transport of samples (Fig. 1).
Este instrumento de auto-recogida de muestras (2) se encuentra en el interior del citado estuche (1), que lo contiene convenientemente ajustado mediante apriete o similar en su contorno para que el citado instrumento no sufra ningun tipo de movimiento dentro del mismo, estando de este modo inamovible. El citado instrumento de auto-recogida (2) se conforma por una canula (21) o tubo corto hueco, un bastoncillo (22) embolo (221), y material esteril (23) adhesivo y/o exfoliante con el cual se recogen debidamente las diferentes muestras.This sample self-collection instrument (2) is located inside said case (1), which contains it conveniently adjusted by tightening or similar in its contour so that said instrument does not suffer any movement within it, being thus immovable. Said self-collection instrument (2) is formed by a cannula (21) or hollow short tube, a stick (22) plunger (221), and sterile material (23) adhesive and / or exfoliating with which they are properly collected The different samples.
55
1010
15fifteen
20twenty
2525
3030
Los tipos de muestras biologicas que una persona puede realizarse as! misma con el sistema objeto del invento y procedimiento asociado, son muestras procedentes de boca, nariz, parpados, ano, vagina, cuello uterino y pene.The types of biological samples that a person can perform as well! same with the system object of the invention and associated procedure, are samples from mouth, nose, eyelids, anus, vagina, cervix and penis.
Es por ello que el instrumento de auto-recogida (2) que constituye el sistema puede adquirir distintas configuraciones para facilitar la recogida de las distintas muestras, dependiendo de la zona a analizar; siendo las configuraciones preferentes de este instrumento de auto-recogida la denominada como bastoncillo (Fig. 2, 3 y 4) y la denominada convexa (Fig. 5 y 6), senalando que la configuracion convexa puede tener un orificio o cavidad central (25) en su extremo para la adecuada salida y posterior entrada de un Hquido en su interior.That is why the self-collection instrument (2) that constitutes the system can acquire different configurations to facilitate the collection of the different samples, depending on the area to be analyzed; the preferred configurations of this self-collection instrument being the so-called stick (Fig. 2, 3 and 4) and the so-called convex (Fig. 5 and 6), indicating that the convex configuration may have a hole or central cavity (25 ) at its end for proper exit and subsequent entry of a liquid inside.
En el caso de la configuracion en bastoncillo (Fig. 2 y 3), el instrumento de auto- recogida (2) se constituye por una canula (21) abierta en sus dos planos extremos (211 y 212) que recoge el material biologico objeto a analisis, por medio de un determinado bastoncillo (22) que esta ubicado en su interior longitudinalmente, de tal manera que este bastoncillo (22) se desplaza por el interior de la citada canula (21) hasta entrar en contacto con la superficie de analisis. En este extremo el bastoncillo (22) posee unas cerdas de material esteril (23) a modo de cepillo, torunda, material exfoliante, adhesivo o similar que se impregna de material biologico mediante un movimiento de friccion sobre la zona a analizar talque movimientos verticales, de rotation axial o vibration.In the case of the stick configuration (Fig. 2 and 3), the self-collection instrument (2) is constituted by a cannula (21) open in its two extreme planes (211 and 212) that collects the biological material object to analysis, by means of a certain swab (22) that is located inside it longitudinally, such that this swab (22) moves through the interior of said cannula (21) until it comes into contact with the analysis surface . At this end the swab (22) has bristles of sterile material (23) as a brush, swab, exfoliating, adhesive or similar material that is impregnated with biological material by means of a friction movement on the area to be analyzed such vertical movements, of axial rotation or vibration.
Se hace notar que las cerdas de material esteril (23) indicadas solidarias al movimiento del bastoncillo (22) puede ser manual (Fig. 2), a traves de un travesano (223) o elemento perpendicular al bastoncillo (22) el cual se encuentra fijado en el extremo contrario a la toma de la muestra y posibilita la extraction y movimiento de las cerdas de material esteril (23) sobre la zona de obtencion de la muestra; o mecanico (Fig.4), a traves de un motor electrico o electronico ubicado en el interior de la canula (21) y que transmite el citado movimiento de friccion alIt is noted that the bristles of sterile material (23) indicated in solidarity with the movement of the stick (22) can be manual (Fig. 2), through a crossbar (223) or element perpendicular to the stick (22) which is located fixed at the opposite end of the sample and allows the extraction and movement of the bristles of sterile material (23) over the sample collection area; or mechanical (Fig. 4), through an electric or electronic motor located inside the cannula (21) and transmitting said friction movement to the
55
1010
15fifteen
20twenty
2525
3030
bastoncillo (22) mecanicamente por un eje regulable por un dispositivo reductor de revoluciones.stick (22) mechanically by an axis adjustable by a speed reducing device.
De manera analoga, con la configuration convexa del instrumento de auto- recogida (2) (Fig.5), se toma la muestra de material biologico tambien mediante friction a traves del citado material esteril, preferentemente de material exfoliante y/o adhesivo (231), que se encuentra ubicado sobre la superficie curvada hacia fuera o convexa (24) de la canula o similar, es decir, en este caso la zona de impregnation de material biologico se ubica sobre la superficie exterior del tubo corto o canula (21). De esta manera la impregnacion de la muestra se obtiene sobre el material esteril tambien por movimientos verticales, de rotation axial o vibration, pero sobre el extremo curvado o convexo (24) de la canula. Esta action tambien puede ser manual o mecanica a traves de un motor ubicado en el interior de la canula (21).Similarly, with the convex configuration of the self-collection instrument (2) (Fig. 5), the sample of biological material is also taken through friction through said sterile material, preferably exfoliating and / or adhesive material (231 ), which is located on the curved outward or convex surface (24) of the cannula or similar, that is, in this case the impregnation zone of biological material is located on the outer surface of the short or cannulated tube (21) . In this way the impregnation of the sample is obtained on the sterile material also by vertical movements, axial rotation or vibration, but on the curved or convex end (24) of the cannula. This action can also be manual or mechanical through an engine located inside the cannula (21).
Como se ha citado previamente, la configuracion convexa admite un orificio (25) o cavidad central en su extremo para la adecuada salida y posterior entrada de un Hquido esteril que contiene la canula (21) en el interior de sus paredes (Fig.6). En esta configuracion, la canula (21) recoge el material biologico que ha quedado suspendido en el Hquido esteril que hay en el interior de la canula (21) o tubo corto hueco. Este Hquido esteril (26) ha tenido que ser previamente expuldaso mediante presion de un embolo (221) a traves del citado orificio central (25), de tal manera que la zona o cavidad corporal de la que se pretende obtener la muestra biologica se llena con el Hquido esteril citado, para que posteriormente tanto el Hquido como los restos biologicos sean recogidos nuevamente al interior de la canula (21). Esta introduction al interior de la canula (21), se realiza manualmente por la accion de un muelle (27) o resorte situado entre el embolo (221) y una de las caras externas de la canula que se encuentra cerrada. Se hace notar que el citado embolo (221) tiene la misma disposition del bastoncillo (22) y el travesano (223) citados previamente, pero se introduce un elemento perpendicular a la baseAs previously mentioned, the convex configuration admits a hole (25) or central cavity at its end for the adequate exit and subsequent entry of a sterile liquid containing the cannula (21) inside its walls (Fig. 6) . In this configuration, the cannula (21) collects the biological material that has been suspended in the sterile liquid inside the cannula (21) or hollow short tube. This sterile liquid (26) has had to be previously expelled by pressing a plunger (221) through said central hole (25), so that the area or body cavity from which the biological sample is intended to be filled is filled with the aforementioned Sterile Liquid, so that later both the Liquid and the biological remains are collected again inside the cannula (21). This introduction to the interior of the cannula (21), is done manually by the action of a spring (27) or spring located between the plunger (221) and one of the external faces of the cannula that is closed. It is noted that said plunger (221) has the same arrangement of the rod (22) and the crossbar (223) previously mentioned, but an element perpendicular to the base is introduced
55
1010
15fifteen
20twenty
2525
3030
(222) mas proxima de la zona convexa, con igual section a las paredes del cilindro sobre el que se desplaza longitudinalmente.(222) closer to the convex zone, with equal section to the cylinder walls on which it travels longitudinally.
Una vez descrito el sistema para la auto-recogida de muestras biologicas y conjunto de elementos que lo conforman, es necesario definir los distintos pasos que integran el procedimiento asociado para su correcto uso.Once the system for the self-collection of biological samples and the set of elements that make it up is described, it is necessary to define the different steps that make up the associated procedure for its correct use.
Como se ha citado previamente, el procedimiento asociado se inicia con la auto- toma de una muestra biologica mediante el instrumento de auto-recogida (2) adecuado segun la zona corporal a analizar (paso a). Esta recogida se realiza mediante el frotis o friction del material esteril (23) cerdas a modo de cepillo, torunda, material exfoliante, adhesivo (231) o similar sobre la zona que es susceptible a la obtencion de la muestra.As previously mentioned, the associated procedure begins with the self-taking of a biological sample by means of the appropriate self-collection instrument (2) according to the body area to be analyzed (step a). This collection is done by smear or friction of the sterile material (23) bristles by way of brush, swab, exfoliating material, adhesive (231) or the like on the area that is susceptible to obtaining the sample.
Una vez que el material biologico es recogido por el citado material esteril (23), independientemente de la configuracion del instrumento de auto-recogida (2), los restos biologicos extraidos se depositan por transferencia convenientemente en una unidad de material secante (3) (paso b). Esta unidad que protege la integridad de los acidos nucleicos contenidos en la misma, se introduce en un habitaculo habilitado en el estuche (1) citado previamente que forma parte del sistema del invento.Once the biological material is collected by said sterile material (23), regardless of the configuration of the self-collection instrument (2), the extracted biological remains are conveniently deposited by transfer in a unit of drying material (3) ( step b). This unit, which protects the integrity of the nucleic acids contained therein, is introduced into a room enabled in the case (1) previously mentioned that is part of the system of the invention.
A continuation, este estuche (1) con la unidad de material secante y absorbente (3) alojada en su interior, es introducido en el interior de un definido paquete (4) de transporte (paso c). Este paquete (4) contiene impreso sobre su superficie la direction de envio del centro de analisis (41), departamento de analisis o similar, y ademas una identification unica (42) talque un codigo alfanumerico, codigo de barras o semejante de tal manera que el tomador de la muestra posee un codigo unico con cada sistema de auto-recogida utilizado (Fig. 7).Then, this case (1) with the unit of drying and absorbent material (3) housed inside it, is introduced inside a defined transport package (4) (step c). This package (4) contains printed on its surface the shipping address of the analysis center (41), analysis department or the like, and also a unique identification (42) such as an alphanumeric code, bar code or similar in such a way that The sample holder has a unique code with each self-collection system used (Fig. 7).
Finalmente, tras el transporte del paquete (4) de envfo en su conjunto, los restos biologicos depositados en la unidad de material secante (3) son analizados para obtener el perfil genetico del propio tomador, o para la identification de agentes patogenos contenidos en ella para su utilizacion en el genotipado del propio 5 tomador (paso d). Por todo ello, y a fin de facilitar el modo de empleo adecuadoFinally, after transporting the shipping package (4) as a whole, the biological remains deposited in the drying material unit (3) are analyzed to obtain the genetic profile of the policyholder itself, or for the identification of pathogenic agents contained in it. for use in the genotyping of the taker himself (step d). For all this, and in order to facilitate the appropriate mode of use
para realizar tanto la auto-toma como el envio de la muestra obtenida con restos biologicos, el sistema para la auto-recogida objeto del presente invento incorpora en el interior de cada estuche una ilustracion o prospecto con las indicaciones de uso (Fig.8).To carry out both the self-collection and the shipment of the sample obtained with biological remains, the system for the self-collection object of the present invention incorporates an illustration or leaflet with the indications for use inside of each case (Fig. 8) .
1010
Por todo lo cual, y una vez seguidos cada uno de los pasos indicados, los resultados obtenidos son devueltos al tomador de la muestra (paso e) que inicialmente se ha registrado en un determinado portal web con sus datos y la identificacion unica de su sistema de auto-recogida. Es por ello que los resultados 15 de las pruebas realizadas llegan al tomador mediante correo postal y/o a traves delFor all of which, and once each of the steps indicated has been followed, the results obtained are returned to the sample holder (step e) that initially has been registered in a certain web portal with its data and the unique identification of its system of self-collection. That is why the results 15 of the tests performed reach the policyholder by postal mail and / or through the
citado portal web.cited web portal.
Descrita suficientemente en lo que precede la naturaleza del invento, teniendo en cuenta que los terminos que se han redactado en esta memoria descriptiva deberan 20 ser tomados en sentido amplio y no limitativo, as! como la description del modoDescribed sufficiently in what precedes the nature of the invention, taking into account that the terms that have been drafted in this specification should be taken in a broad and non-limiting sense, as! as the description of the mode
de llevarlo a la practica. Y, demostrando que constituye un positivo adelanto tecnico, es por lo que se solicita el registro de la patente, siendo lo que constituye la esencia del referido invento lo que a continuation se especifica en las siguientes reivindicaciones.of putting it into practice. And, demonstrating that it constitutes a positive technical advance, it is for which the patent registration is requested, being what constitutes the essence of the aforementioned invention what is specified below in the following claims.
2525
Claims (3)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ES201630932A ES2649029B1 (en) | 2016-07-08 | 2016-07-08 | SYSTEM FOR SELF-COLLECTION OF SAMPLES AND ASSOCIATED PROCEDURE |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ES201630932A ES2649029B1 (en) | 2016-07-08 | 2016-07-08 | SYSTEM FOR SELF-COLLECTION OF SAMPLES AND ASSOCIATED PROCEDURE |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| ES2649029A1 ES2649029A1 (en) | 2018-01-09 |
| ES2649029B1 true ES2649029B1 (en) | 2018-07-30 |
Family
ID=60860101
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES201630932A Active ES2649029B1 (en) | 2016-07-08 | 2016-07-08 | SYSTEM FOR SELF-COLLECTION OF SAMPLES AND ASSOCIATED PROCEDURE |
Country Status (1)
| Country | Link |
|---|---|
| ES (1) | ES2649029B1 (en) |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4635488A (en) * | 1984-12-03 | 1987-01-13 | Schleicher & Schuell, Inc. | Nonintrusive body fluid samplers and methods of using same |
| US5479937A (en) * | 1989-09-21 | 1996-01-02 | Epitope, Inc. | Oral collection device |
| FI1592U1 (en) * | 1994-07-11 | 1994-10-26 | Elias Hakalehto | Spruta, foeretraedesvis injectionspruta |
| JP2007526807A (en) * | 2004-02-23 | 2007-09-20 | エシコン・インコーポレイテッド | Diagnostic test equipment |
| US20090143699A1 (en) * | 2007-11-29 | 2009-06-04 | John Wu | Fluid sample collecting and analyzing apparatus |
-
2016
- 2016-07-08 ES ES201630932A patent/ES2649029B1/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| ES2649029A1 (en) | 2018-01-09 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| ES2568434T3 (en) | Sampling system | |
| Sharma et al. | Safety and blood sample volume and quality of a refined retro-orbital bleeding technique in rats using a lateral approach | |
| US20160354021A1 (en) | Methods and systems for a sample collection device with a novelty exterior | |
| US20070106174A1 (en) | Intrauterine anesthetic applicator and cell collection device and method of use | |
| BR112020010783A2 (en) | universal self-sampling kit, methods and use | |
| ES2649029B1 (en) | SYSTEM FOR SELF-COLLECTION OF SAMPLES AND ASSOCIATED PROCEDURE | |
| AU2017291843B2 (en) | Improved vaginal cell or cervical cell collection device | |
| US20240032898A1 (en) | Sample collection device, sample collection kit, sample collection system, diagnostic device, and associated methods | |
| WO2023119113A1 (en) | Device for collection of biological samples, container for this device and method of collection of biological samples | |
| RU157878U1 (en) | CYCLE BRUSH "DIATEST" | |
| CN215227859U (en) | A nasopharynx secretion protection type collection system for viral respiratory infection | |
| JP7236112B2 (en) | HVS and PAP smear test equipment | |
| RU186133U1 (en) | DEVICE FOR FENCING BIOLOGICAL MATERIAL FROM THE WEDGE-SHAPED SINUS OF THE NOSE | |
| CN212281432U (en) | Self-service collection suit for nasopharynx swab | |
| CN209751106U (en) | cervical canal and cervical cell sampler | |
| RU222091U1 (en) | Device for self-collection of cervico-vaginal discharge | |
| RU222041U1 (en) | Device for self-collection of cervico-vaginal material | |
| CN205144616U (en) | Disposable cervical sampler | |
| RU2372050C1 (en) | Cow's vagina fixation device | |
| CN207979792U (en) | A kind of Occluding device that can be deformed | |
| CN205597886U (en) | With rhinoscope complex bandage | |
| RU134777U1 (en) | DEVICE FOR COLLECTING BIOLOGICAL MATERIAL FROM THE VAGINA IN BACTERIAL VAGINOSIS | |
| WO2023119115A1 (en) | Device for collection of biological samples, container for this device and method of collection of biological samples | |
| RU76563U1 (en) | Probe for Chlamydia Sampling from the Mucous Nasal and Pharyngeal Cavities | |
| RU87616U1 (en) | MEANS FOR COLLECTING THE TESTED BIOLOGICAL MATERIAL FROM THE SURFACE OF THE Cervix |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FG2A | Definitive protection |
Ref document number: 2649029 Country of ref document: ES Kind code of ref document: B1 Effective date: 20180730 |