WO2017140935A1 - Device for collecting and transferring samples in anaerobiosis - Google Patents

Device for collecting and transferring samples in anaerobiosis Download PDF

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Publication number
WO2017140935A1
WO2017140935A1 PCT/ES2017/070087 ES2017070087W WO2017140935A1 WO 2017140935 A1 WO2017140935 A1 WO 2017140935A1 ES 2017070087 W ES2017070087 W ES 2017070087W WO 2017140935 A1 WO2017140935 A1 WO 2017140935A1
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WO
WIPO (PCT)
Prior art keywords
container
closure
opening
bag
threaded surface
Prior art date
Application number
PCT/ES2017/070087
Other languages
Spanish (es)
French (fr)
Inventor
Susana Delgado Palacio
Borja SÁNCHEZ GARCÍA
Claudio HIDALGO CANTABRANA
Abelardo Margolles Barros
José Ignacio RODRÍGUEZ GARCÍA
Original Assignee
Consejo Superior De Investigaciones Científicas (Csic)
Universidad De Oviedo
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Publication of WO2017140935A1 publication Critical patent/WO2017140935A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0096—Casings for storing test samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D47/00—Closures with filling and discharging, or with discharging, devices
    • B65D47/36—Closures with frangible parts adapted to be pierced, torn or removed, to provide discharge openings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0038—Devices for taking faeces samples; Faecal examination devices
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/16—Reagents, handling or storing thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/046—Function or devices integrated in the closure
    • B01L2300/047—Additional chamber, reservoir
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0672—Integrated piercing tool
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped

Definitions

  • the present invention falls within the technical field of containers specially adapted for medical or pharmaceutical purposes, specifically those designed to collect, store or administer blood, plasma or medical fluids, and refers in particular to a device for collecting and transfer samples under anaerobic conditions, said samples being preferably stool.
  • the intestinal microbial or microbiota population represents 90% of the cells of the human organism, and comprises a great diversity of microorganisms, which also varies widely among individuals.
  • a common characteristic of this microbiota is that it is anaerobic organisms, whether strict or optional; that is, that oxygen is highly toxic and prevents its proliferation and survival.
  • microorganisms present in the intestine play a fundamental role in digestive health, but several studies have shown that they also influence the general immune system of the individual, so their isolation and study is considered of great interest.
  • Sampling of said microbiota in humans is mainly based on feces, since they contain a large part of the intestinal microbial load.
  • the conservation of these samples in the best possible conditions is of great interest to subsequently be able to isolate, cultivate and analyze the microbiota in the laboratory.
  • This process is conditioned by the high sensitivity to aerobic conditions (presence of oxygen) present in the external environment, so it must be obtained and processed under anaerobic conditions and in the shortest possible time to avoid losses that influence the results obtained.
  • This invention differs from other stool collection bottles in that it provides the advantage of helping to maintain viable anaerobic intestinal microorganisms by avoiding their contact with molecular oxygen. It is very useful to be able to conserve, isolate and recover strict anaerobic microorganisms that constitute the majority microbial fraction of the intestinal microbiota.
  • This type of container for collecting, storing and transporting feces under anaerobic conditions is of special interest to researchers and clinicians working in the field of microbiology, specifically in the study of the intestinal microbiota, as well as for analysis and diagnosis laboratories. that receive stool samples for coproculture. DESCRIPTION OF THE INVENTION
  • the object of the invention consists of a device for collecting and transferring biological samples, preferably designed for faecal material, which allows to obtain and maintain anaerobic conditions that preserve the viability of the anaerobic intestinal microbiota until it is processed in the laboratory.
  • the device is embodied in a container, preferably of cylindrical and hollow geometry, said cylinder having one of its faces open so that it configures a circular opening to access the hollow interior.
  • This opening has a first threaded surface to secure the closure with a cylindrical cover, said lid being in turn provided with a second threaded surface corresponding to the first.
  • the interposition of a rubber seal between the opening and the lid is further contemplated to seal the obtained closure.
  • the cylindrical body of the lid has a defined sleeve, also cylindrical, which connects the inside of the container with the outside atmosphere.
  • a manually operated plug fitted with a sharp end, is displaced inside said bushing.
  • Said cap descends from an upper position to a lower one, where its sharp end comes into contact with a body, generally a bag, containing a liquid, preferably water.
  • a body generally a bag, containing a liquid, preferably water.
  • Said bag is generally made of a breakable plastic material by the incision of the puncturing end of the cap, at which time the contained liquid is released.
  • a reagent generating anaerobic conditions is arranged in a position lower than the lid.
  • Said reagent is usually contained in an envelope or a bag of walls permeable, which contains inside the mixture of components capable of chemically binding oxygen from the surrounding atmosphere, thereby achieving an anaerobic environment.
  • Various compositions capable of performing this oxygen sequestration are known in the current market, among which the Anaerocult ® of Merck ® is highlighted, comprising a mixture that includes diatomite, iron powder, citric acid, sodium carbonate and crystalline silica, whose wetting triggers a series of reactions that chemically bind oxygen, creating a C0 2 atmosphere.
  • the container bag of oxygen binding components is disposed on an annular bowl-type support located inside the container, in a position close to the opening, so that in the hollow space inside the container that is under the bowl and the reagent bag in it supported create a chamber where the sample to be stored is arranged and in which an anaerobic atmosphere is obtained thanks to the action of the chemical binding components.
  • the device thus described allows the collection of the stool sample directly by introducing it inside the container.
  • the immediate subsequent arrangement of the tray with the container envelope of binder elements inside said container and its closure by threading the lid allows the sample to be isolated from the surrounding atmosphere.
  • the closure cap is manipulated manually, which produces the release of the liquid contained in the plastic body, which falls on top of the envelope, whose permeable walls allow it to be introduced inside, triggering the reactions that give rise to oxygen recruitment, generating anaerobic conditions.
  • the cap of the device lacks a sharp end, just as the device has no water container body. In this simpler embodiment, the cap only displaces through the interior of the bushing until it is completely removed, thereby allowing the connection of the interior of the container with the atmosphere.
  • a liquid is introduced, preferably water, either directly, or using some appropriate means, such as a pipette or a dispenser, to influence the reagent, at which time the cap is reinserted to seal the cap and allow the creation and maintenance of anaerobic conditions.
  • the device is preferably applicable for the collection of fecal material of both human and animal origin, while maintaining the viability of the fecal microbiota.
  • human fecal material such conservation, which allows the revival, culture and isolation of its anaerobic constituents, is interesting in treatments such as fecal transplantation, in which maintaining the original microbial composition and ensuring its viability are critical factors.
  • the maintenance of the viability of the fecal microbiota of different animal species of zootechnical interest has a very large projection and applicability in the veterinary field, being useful for the possible development of derived biotherapeutic products, based on partial restitution or Total anaerobic components of the microbiota in the animal intestinal environment.
  • Figure 1. Shows a perspective view of an exploded view of the device, in which its main constituent elements are appreciated.
  • Figure 2. Shows a frontal view of a longitudinal section of the device, in which its main constituent elements are appreciated.
  • Figure 3. Shows a bottom perspective view of the device closure.
  • Figure 4. Shows a bottom perspective view of the activating body of the device.
  • Figure 5. Shows a top perspective view of the support of the anaerobic condition generating element.
  • the sample collection and transfer device preferably stool, under anaerobic conditions, comprises a container (1) of essentially cylindrical and hollow geometry, with one of its bases open as shown in Figure 1. Said open base defines an opening (2) for access to the hollow interior of the container (1), said opening (2) being provided perimetrically with a first threaded surface (3).
  • a closure (4) of essentially cylindrical geometry and diametral dimensions coinciding with those of the opening (2) of the cylinder of the container (1), covers said opening (2) by threading between a second threaded surface (5) practiced in its perimeter , and the first threaded surface (3) of the opening (2).
  • the closure (4) is provided with an activating cap (6), longitudinally movable by way of a piston inside an essentially cylindrical bushing (7) defined in the body of the closure (4), between an upper end of the bushing (7 ) in contact with the outside environment and a lower end in contact with the inside of the container (1).
  • an activating cap (6) longitudinally movable by way of a piston inside an essentially cylindrical bushing (7) defined in the body of the closure (4), between an upper end of the bushing (7 ) in contact with the outside environment and a lower end in contact with the inside of the container (1).
  • a liquid-containing bag (8) of essentially spherical geometry is arranged, said bag (8) being made of a plastic material that can be broken by pressure of the plug.
  • the longitudinal displacement of the activating cap (6) inside the bush (7) is carried out by contact screwing between a third threaded surface (9) practiced in the activating cap (6) and a fourth threaded surface (10) practiced in the inner wall of the bushing (7), as shown in figure 3. It is envisioned that the lower end of the activating cap (6), intended to press the bag (8), has a sharp element (11), as shown in figure 4, to facilitate the breakage of the wall of said bag (8).
  • annular support or bowl (12) In the hollow interior of the container (1), in an area close to the opening (2), an annular support or bowl (12) is arranged, with external diametral dimensions similar to those of the interior of the container (1), intended for housing a reactive material (13) generator of anaerobic conditions.
  • Said reactive material (13), is contained in a bag made of permeable material that contains in its interior components that, upon contact with water, chemically bind oxygen rapidly, thereby producing an anaerobic environment and a C0 atmosphere. 2 .
  • a typical composition of reactive material (13) includes diatomite, iron powder, citric acid, sodium carbonate and crystalline silica, as for example in the case of Merck ® Anaerocult ®.
  • the bowl (12) incorporates a plurality of openings (14) in its perimeter, as illustrated in Figure 5, to allow the exchange of gases during the creation of the anaerobic environment.
  • a first annular seal (15) is additionally incorporated in the contact area between the opening (2) and the closure (4) and a second joint (16) between the activating cap (6) and the upper opening of the bushing (7) in which it moves.
  • the sample collection and transfer device preferably designed for feces, allows a sample to be taken directly inside the container (1) through the opening (2), which is immediately covered by the placement of the closure (4), said closure (4) being secured by threading between its second threaded surface (5) and the first threaded surface (3) of the opening (2).

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Clinical Laboratory Science (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Mechanical Engineering (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

A device for collecting and transferring samples in anaerobiosis, comprising a vessel (1) with an opening (2), and a closure (4) for covering the opening (2), in which the closure (4) incorporates a manually operated activator plug (6) that releases an activator element contained in a bag (8) to start a chain of reactions determined by a reagent material (13) capable of creating an anaerobic atmosphere inside the vessel (1). The device is preferably designed for the case in which said samples are stool, of human or animal origin, with the aim of preserving the viability of the gut microbiota and being able to proceed with their later revival in the laboratory.

Description

DISPOSITIVO DE RECOGIDA Y TRASLADO DE MUESTRAS EN ANAEROBIOSIS  DEVICE FOR COLLECTION AND TRANSFER OF SAMPLES IN ANAEROBIOSIS
DESCRIPCIÓN OBJETO DE LA INVENCIÓN DESCRIPTION OBJECT OF THE INVENTION
La presente invención se encuadra en el campo técnico de los recipientes especialmente adaptados a fines médicos o farmacéuticos, concretamente a aquellos concebidos para recoger, almacenar o administrar sangre, plasma o fluidos de uso médico, y se refiere en particular a un dispositivo para recoger y trasladar muestras en condiciones anaeróbicas, siendo dichas muestras preferentemente heces. The present invention falls within the technical field of containers specially adapted for medical or pharmaceutical purposes, specifically those designed to collect, store or administer blood, plasma or medical fluids, and refers in particular to a device for collecting and transfer samples under anaerobic conditions, said samples being preferably stool.
ANTECEDENTES DE LA INVENCIÓN La población microbiana o microbiota intestinal representa el 90% de las células del organismo humano, y comprende una gran diversidad de microorganismos, que además varía ampliamente entre individuos. Sin embargo, una característica común de dicha microbiota es que se trata de organismos anaerobios, bien sean estrictos o facultativos; es decir, que el oxígeno resulta altamente tóxico e impide su proliferación y supervivencia. BACKGROUND OF THE INVENTION The intestinal microbial or microbiota population represents 90% of the cells of the human organism, and comprises a great diversity of microorganisms, which also varies widely among individuals. However, a common characteristic of this microbiota is that it is anaerobic organisms, whether strict or optional; that is, that oxygen is highly toxic and prevents its proliferation and survival.
Los microorganismos presentes en el intestino desempeñan un papel fundamental en la salud digestiva, pero diversos estudios han demostrado que también influyen en el sistema inmunitario general del individuo, por lo que su aislamiento y estudio se considera de gran interés. The microorganisms present in the intestine play a fundamental role in digestive health, but several studies have shown that they also influence the general immune system of the individual, so their isolation and study is considered of great interest.
El muestreo de dicha microbiota en humanos se realiza principalmente a partir de las heces, ya que contienen gran parte de la carga microbiana intestinal. La conservación de dichas muestras en las mejores condiciones posibles resulta de gran interés para posteriormente poder aislar, cultivar y analizar la microbiota en el laboratorio. Este proceso viene condicionado por la alta sensibilidad a las condiciones aeróbicas (presencia de oxígeno) presentes en el medio ambiente exterior, por lo que debe obtenerse y procesarse en condiciones anaeróbicas y en el menor plazo de tiempo posible para así evitar pérdidas que influyan en los resultados obtenidos. Sampling of said microbiota in humans is mainly based on feces, since they contain a large part of the intestinal microbial load. The conservation of these samples in the best possible conditions is of great interest to subsequently be able to isolate, cultivate and analyze the microbiota in the laboratory. This process is conditioned by the high sensitivity to aerobic conditions (presence of oxygen) present in the external environment, so it must be obtained and processed under anaerobic conditions and in the shortest possible time to avoid losses that influence the results obtained.
Esta invención se diferencia de otros frascos de recogida de heces en que aporta la ventaja de ayudar a mantener viables los microorganismos intestinales anaerobios evitando su contacto con el oxígeno molecular. Resulta de mucha utilidad para poder conservar, aislar y recuperar microorganismos anaerobios estrictos que constituyen la fracción microbiana mayoritaria de la microbiota intestinal. Este tipo de recipiente de recogida, almacenamiento y transporte de heces en condiciones anaeróbicas es de especial interés para investigadores y clínicos que trabajen en el campo de la microbiología, en concreto en el estudio de la microbiota intestinal, así como para laboratorios de análisis y diagnóstico que reciban muestras de heces para coprocultivo. DESCRIPCIÓN DE LA INVENCIÓN This invention differs from other stool collection bottles in that it provides the advantage of helping to maintain viable anaerobic intestinal microorganisms by avoiding their contact with molecular oxygen. It is very useful to be able to conserve, isolate and recover strict anaerobic microorganisms that constitute the majority microbial fraction of the intestinal microbiota. This type of container for collecting, storing and transporting feces under anaerobic conditions is of special interest to researchers and clinicians working in the field of microbiology, specifically in the study of the intestinal microbiota, as well as for analysis and diagnosis laboratories. that receive stool samples for coproculture. DESCRIPTION OF THE INVENTION
El objeto de la invención consiste en un dispositivo de recogida y traslado de muestras biológicas, preferentemente concebido para material fecal, que permite obtener y mantener condiciones anaeróbicas que preservan la viabilidad de la microbiota intestinal anaeróbica hasta el momento de su procesado en laboratorio. The object of the invention consists of a device for collecting and transferring biological samples, preferably designed for faecal material, which allows to obtain and maintain anaerobic conditions that preserve the viability of the anaerobic intestinal microbiota until it is processed in the laboratory.
El dispositivo se materializa en un recipiente, preferentemente de geometría cilindrica y hueca, teniendo dicho cilindro una de sus caras abiertas de modo que configura una abertura circular para acceder al interior hueco. Esta abertura cuenta con una primera superficie roscada para asegurar el cierre con una tapa cilindrica, estando dicha tapa dotada a su vez de una segunda superficie roscada en correspondencia con la primera. Se contempla adicionalmente la interposición de una junta de goma entre la abertura y la tapa, para hermetizar el cierre obtenido. El cuerpo cilindrico de la tapa tiene definido un casquillo, también cilindrico, que conecta el interior del recipiente con la atmósfera exterior. Por el interior de dicho casquillo se desplaza un tapón accionable manualmente, dotado de un extremo punzante. Dicho tapón desciende desde una posición superior hasta una inferior, donde su extremo punzante entra en contacto con un cuerpo, generalmente una bolsa, que contiene un líquido, preferentemente agua. Dicha bolsa está generalmente realizada en un material plástico rompible por la incisión del extremo punzante del tapón, momento en el que se libera el líquido contenido. The device is embodied in a container, preferably of cylindrical and hollow geometry, said cylinder having one of its faces open so that it configures a circular opening to access the hollow interior. This opening has a first threaded surface to secure the closure with a cylindrical cover, said lid being in turn provided with a second threaded surface corresponding to the first. The interposition of a rubber seal between the opening and the lid is further contemplated to seal the obtained closure. The cylindrical body of the lid has a defined sleeve, also cylindrical, which connects the inside of the container with the outside atmosphere. A manually operated plug, fitted with a sharp end, is displaced inside said bushing. Said cap descends from an upper position to a lower one, where its sharp end comes into contact with a body, generally a bag, containing a liquid, preferably water. Said bag is generally made of a breakable plastic material by the incision of the puncturing end of the cap, at which time the contained liquid is released.
En una posición inferior a la tapa se dispone un reactivo generador de condiciones anaerobias. Dicho reactivo suele estar contenido en un sobre o un saco de paredes permeables, que contiene en su interior la mezcla de componentes capaces de ligar químicamente el oxígeno de la atmósfera que lo rodea, consiguiendo de esa manera un entorno anaerobio. Se conocen en el mercado actual diversas composiciones capaces de realizar este secuestro de oxígeno, de entre las cuales se cita de manera destacada el Anaerocult ® de Merck ®, que comprende una mezcla que incluye diatomita, polvo de hierro, ácido cítrico, carbonato de sodio y sílice cristalino, cuya humectación desencadena una serie de reacciones que ligan químicamente el oxígeno, creando una atmósfera de C02. Según una realización preferente, el saco contenedor de componentes ligantes de oxígeno se dispone sobre un soporte tipo cazoleta anular situada en el interior del recipiente, en una posición próxima a la abertura, de forma que en el espacio hueco del interior del recipiente que queda bajo la cazoleta y el saco de reactivo en él soportado se cree una cámara donde se dispone la muestra a conservar y en la cual se obtiene una atmósfera anaeróbica gracias a la acción de los componentes químicos ligantes. A reagent generating anaerobic conditions is arranged in a position lower than the lid. Said reagent is usually contained in an envelope or a bag of walls permeable, which contains inside the mixture of components capable of chemically binding oxygen from the surrounding atmosphere, thereby achieving an anaerobic environment. Various compositions capable of performing this oxygen sequestration are known in the current market, among which the Anaerocult ® of Merck ® is highlighted, comprising a mixture that includes diatomite, iron powder, citric acid, sodium carbonate and crystalline silica, whose wetting triggers a series of reactions that chemically bind oxygen, creating a C0 2 atmosphere. According to a preferred embodiment, the container bag of oxygen binding components is disposed on an annular bowl-type support located inside the container, in a position close to the opening, so that in the hollow space inside the container that is under the bowl and the reagent bag in it supported create a chamber where the sample to be stored is arranged and in which an anaerobic atmosphere is obtained thanks to the action of the chemical binding components.
El dispositivo así descrito permite la toma de la muestra de heces directamente mediante su introducción en el interior del recipiente. La inmediatamente posterior disposición de la bandeja con el sobre contenedor de elementos ligantes en el interior de dicho recipiente y su cierre mediante roscado de la tapa permite el aislamiento de la muestra respecto de la atmósfera circundante. The device thus described allows the collection of the stool sample directly by introducing it inside the container. The immediate subsequent arrangement of the tray with the container envelope of binder elements inside said container and its closure by threading the lid allows the sample to be isolated from the surrounding atmosphere.
Para conseguir la atmósfera anaerobia que asegure las condiciones óptimas de conservación de la microbiota, se manipula manualmente el tapón del cierre, que produce la liberación del líquido contenido en el cuerpo plástico, el cual cae encima del sobre, cuyas paredes permeables permiten que se introduzca en el interior, desencadenando las reacciones que dan lugar al reclutamiento del oxígeno, generando las condiciones anaeróbicas. En una realización alternativa, el tapón del dispositivo carece de extremo punzante, así como el dispositivo no cuenta con ningún cuerpo contenedor de agua. En esta realización más sencilla, el tapón únicamente desplaza por el interior del casquillo hasta ser extraído por completo, permitiendo de ese modo la conexión del interior del recipiente con la atmósfera. A través de esa abertura creada por la retirada del tapón se procede a la introducción de un líquido, preferentemente agua, ya sea directamente, o utilizando algún medio apropiado, como por ejemplo una pipeta o un dosificador, para que incida sobre el reactivo, momento en el que se vuelve a insertar el tapón para obturar el casquillo y permitir la creación y el mantenimiento de las condiciones anaerobias. El dispositivo es preferentemente aplicable para la recogida de material fecal tanto de origen humano como de origen animal, manteniendo la viabilidad de la microbiota fecal. En el caso del material fecal humano, dicha conservación, que permite la revivificación, el cultivo y el aislamiento de sus integrantes anaeróbicos es interesante en tratamientos como el trasplante fecal, en el que mantener la composición microbiana original y asegurar su viabilidad son factores críticos. To achieve the anaerobic atmosphere that ensures the optimal conditions of microbiota conservation, the closure cap is manipulated manually, which produces the release of the liquid contained in the plastic body, which falls on top of the envelope, whose permeable walls allow it to be introduced inside, triggering the reactions that give rise to oxygen recruitment, generating anaerobic conditions. In an alternative embodiment, the cap of the device lacks a sharp end, just as the device has no water container body. In this simpler embodiment, the cap only displaces through the interior of the bushing until it is completely removed, thereby allowing the connection of the interior of the container with the atmosphere. Through this opening created by the removal of the cap, a liquid is introduced, preferably water, either directly, or using some appropriate means, such as a pipette or a dispenser, to influence the reagent, at which time the cap is reinserted to seal the cap and allow the creation and maintenance of anaerobic conditions. The device is preferably applicable for the collection of fecal material of both human and animal origin, while maintaining the viability of the fecal microbiota. In the case of human fecal material, such conservation, which allows the revival, culture and isolation of its anaerobic constituents, is interesting in treatments such as fecal transplantation, in which maintaining the original microbial composition and ensuring its viability are critical factors.
Por otro lado, el mantenimiento de la viabilidad de la microbiota fecal de distintas especies animales de interés zootécnico presenta una proyección y una aplicabilidad muy grande en el campo veterinario, siendo útil para el posible desarrollo de productos bioterapéuticos derivados, basados en la restitución parcial o total de los componentes anaeróbicos de la microbiota en el ambiente intestinal animal. On the other hand, the maintenance of the viability of the fecal microbiota of different animal species of zootechnical interest has a very large projection and applicability in the veterinary field, being useful for the possible development of derived biotherapeutic products, based on partial restitution or Total anaerobic components of the microbiota in the animal intestinal environment.
DESCRIPCIÓN DE LOS DIBUJOS Para complementar la descripción que se está realizando y con objeto de ayudar a una mejor comprensión de las características de la invención, de acuerdo con un ejemplo preferente de realización práctica de la misma, se acompaña como parte integrante de dicha descripción un juego de dibujos en donde con carácter ilustrativo y no limitativo, se ha representado lo siguiente: DESCRIPTION OF THE DRAWINGS To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, according to a preferred example of practical realization thereof, an integral part of said description is accompanied by set of drawings in which with the illustrative and non-limiting nature, the following has been represented:
Figura 1.- Muestra una vista en perspectiva de un despiece del dispositivo, en la que se aprecian sus principales elementos constituyentes. Figure 1.- Shows a perspective view of an exploded view of the device, in which its main constituent elements are appreciated.
Figura 2.- Muestra una vista frontal de un corte longitudinal del dispositivo, en la que se aprecian sus principales elementos constituyentes. Figure 2.- Shows a frontal view of a longitudinal section of the device, in which its main constituent elements are appreciated.
Figura 3.- Muestra una vista en perspectiva inferior del cierre del dispositivo. Figure 3.- Shows a bottom perspective view of the device closure.
Figura 4.- Muestra una vista en perspectiva inferior del cuerpo activador del dispositivo. Figura 5.- Muestra una vista en perspectiva superior del soporte del elemento generador de condiciones anaerobias. Figure 4.- Shows a bottom perspective view of the activating body of the device. Figure 5.- Shows a top perspective view of the support of the anaerobic condition generating element.
REALIZACIÓN PREFERENTE DE LA INVENCIÓN PREFERRED EMBODIMENT OF THE INVENTION
Seguidamente se proporciona, con ayuda de las figuras anteriormente referidas, una explicación detallada de un ejemplo de realización preferente del objeto de la presente invención. El dispositivo de recogida y traslado de muestras, preferentemente heces, en condiciones de anaerobiosis, comprende un recipiente (1) de geometría esencialmente cilindrica y hueca, con una de sus bases abierta como se muestra en la figura 1. Dicha base abierta define una abertura (2) para acceso al interior hueco del recipiente (1), estando dicha abertura (2) dotada perimetralmente de una primera superficie roscada (3). Next, a detailed explanation of a preferred embodiment of the object of the present invention is provided with the aid of the aforementioned figures. The sample collection and transfer device, preferably stool, under anaerobic conditions, comprises a container (1) of essentially cylindrical and hollow geometry, with one of its bases open as shown in Figure 1. Said open base defines an opening (2) for access to the hollow interior of the container (1), said opening (2) being provided perimetrically with a first threaded surface (3).
Un cierre (4), de geometría esencialmente cilindrica y dimensiones diametrales coincidentes con las de la abertura (2) del cilindro del recipiente (1), tapa dicha abertura (2) mediante roscado entre una segunda superficie roscada (5) practicada en su perímetro, y la primera superficie roscada (3) de la abertura (2). A closure (4), of essentially cylindrical geometry and diametral dimensions coinciding with those of the opening (2) of the cylinder of the container (1), covers said opening (2) by threading between a second threaded surface (5) practiced in its perimeter , and the first threaded surface (3) of the opening (2).
El cierre (4) está dotado de un tapón activador (6), desplazable longitudinalmente a modo de émbolo en el interior de un casquillo (7) esencialmente cilindrico definido en el cuerpo del cierre (4), entre un extremo superior del casquillo (7) en contacto con el ambiente exterior y un extremo inferior en contacto con el interior del recipiente (1). En el extremo inferior del casquillo (7), como se observa en la figura 2, se dispone una bolsa (8) contenedora de líquido, de geometría esencialmente esférica, estando dicha bolsa (8) realizada en un material plástico rompible por presión del tapón activador (6) al llegar al extremo inferior de su desplazamiento en el interior del casquillo (7). El desplazamiento longitudinal del tapón activador (6) en el interior del casquillo (7) se realiza mediante enroscado por contacto entre una tercera superficie roscada (9) practicada en el tapón activador (6) y una cuarta superficie roscada (10) practicada en la pared interior del casquillo (7), como se aprecia en la figura 3. Se prevé que el extremo inferior del tapón activador (6), destinado a presionar a la bolsa (8), tenga un elemento punzante (11), como se muestra en la figura 4, para facilitar la rotura de la pared de dicha bolsa (8). The closure (4) is provided with an activating cap (6), longitudinally movable by way of a piston inside an essentially cylindrical bushing (7) defined in the body of the closure (4), between an upper end of the bushing (7 ) in contact with the outside environment and a lower end in contact with the inside of the container (1). At the lower end of the bushing (7), as seen in Figure 2, a liquid-containing bag (8) of essentially spherical geometry is arranged, said bag (8) being made of a plastic material that can be broken by pressure of the plug. activator (6) upon reaching the lower end of its movement inside the bushing (7). The longitudinal displacement of the activating cap (6) inside the bush (7) is carried out by contact screwing between a third threaded surface (9) practiced in the activating cap (6) and a fourth threaded surface (10) practiced in the inner wall of the bushing (7), as shown in figure 3. It is envisioned that the lower end of the activating cap (6), intended to press the bag (8), has a sharp element (11), as shown in figure 4, to facilitate the breakage of the wall of said bag (8).
En el interior hueco del recipiente (1), en una zona próxima a la abertura (2), se dispone un soporte anular o cazoleta (12), con unas dimensiones diametrales exteriores similares a las del interior del recipiente (1), destinado a albergar un material reactivo (13) generador de condiciones anaerobias. In the hollow interior of the container (1), in an area close to the opening (2), an annular support or bowl (12) is arranged, with external diametral dimensions similar to those of the interior of the container (1), intended for housing a reactive material (13) generator of anaerobic conditions.
Dicho material reactivo (13), está contenido en una bolsa realizada en material permeable que contiene en su interior unos componentes que, al contacto con agua, ligan químicamente el oxígeno de forma rápida, produciendo de esa manera un entorno anaeróbico y una atmósfera de C02. Una composición típica de material reactivo (13) incluye diatomita, polvo de hierro, ácido cítrico, carbonato de sodio y sílice cristalino, como por ejemplo en el caso del Anaerocult ® de Merck ®. La cazoleta (12) incorpora una pluralidad de aberturas (14) en su perímetro, como se ilustra en la figura 5, para permitir el intercambio de gases durante la creación del ambiente anaerobio. Said reactive material (13), is contained in a bag made of permeable material that contains in its interior components that, upon contact with water, chemically bind oxygen rapidly, thereby producing an anaerobic environment and a C0 atmosphere. 2 . A typical composition of reactive material (13) includes diatomite, iron powder, citric acid, sodium carbonate and crystalline silica, as for example in the case of Merck ® Anaerocult ®. The bowl (12) incorporates a plurality of openings (14) in its perimeter, as illustrated in Figure 5, to allow the exchange of gases during the creation of the anaerobic environment.
Se prevé adicionalmente que, para asegurar la estanqueidad entre el interior del recipiente (1) y la atmósfera exterior se incorporen adicionalmente una primera junta (15) anular en la zona de contacto entre la abertura (2) y el cierre (4) y una segunda junta (16) entre el tapón activador (6) y la abertura superior del casquillo (7) en el cual desplaza. It is further provided that, to ensure the tightness between the inside of the container (1) and the outside atmosphere, a first annular seal (15) is additionally incorporated in the contact area between the opening (2) and the closure (4) and a second joint (16) between the activating cap (6) and the upper opening of the bushing (7) in which it moves.
Con los elementos así descritos, el dispositivo de recogida y traslado de muestras, preferentemente concebido para heces, permite la toma de una muestra directamente en el interior del recipiente (1) a través de la abertura (2), la cual es inmediatamente tapada mediante la colocación del cierre (4), quedando dicho cierre (4) asegurado mediante el roscado entre su segunda superficie roscada (5) y la primera superficie roscada (3) de la abertura (2). With the elements thus described, the sample collection and transfer device, preferably designed for feces, allows a sample to be taken directly inside the container (1) through the opening (2), which is immediately covered by the placement of the closure (4), said closure (4) being secured by threading between its second threaded surface (5) and the first threaded surface (3) of the opening (2).
En ese momento, el desplazamiento manual del tapón activador (6) en el interior del casquillo (7) hacia una posición inferior presiona a la bolsa (8) contenedora de líquido situada en dicha posición inferior, hasta producir su rotura y la consecuente liberación del líquido en ella contenido. Dicho líquido cae sobre el material reactivo (13) dispuesto en la cazoleta (12), en una posición inmediatamente inferior a la bolsa (8), atravesando sus paredes permeables y entrando en contacto con los componentes, de manera que se inicia una cadena de reacciones que atrapan químicamente el oxígeno contenido en el interior del recipiente (1) y liberan C02, lo que finalmente crea un entorno anaerobio que permite preservar y mantener viable la microbiota intestinal, principalmente anaeróbica, contenida en la muestra para su posterior recuperación, cultivo y aislamiento en laboratorio. At that time, the manual movement of the activating cap (6) inside the bushing (7) towards a lower position presses the liquid container bag (8) located in said lower position, until it breaks and the consequent release of the liquid in it contained. Said liquid falls on the reactive material (13) disposed in the bowl (12), in a position immediately inferior to the bag (8), crossing its permeable walls and coming into contact with the components, so that a chain of reactions is started that chemically trap the oxygen contained inside the container (1) and release C0 2 , which finally creates an anaerobic environment that allows to preserve and maintain viable the intestinal microbiota, mainly anaerobic, contained in the sample for subsequent recovery, culture and laboratory isolation.

Claims

REIVINDICACIONES
1. Dispositivo de recogida y traslado de muestras en anaerobiosis, que comprende: - un recipiente (1) hueco dotado de una abertura (2) de acceso al interior hueco de dicho recipiente (1), 1. Device for collecting and transferring samples in anaerobiosis, comprising: - a hollow container (1) provided with an access opening (2) to the hollow interior of said container (1),
un cierre (4) de geometría y dimensiones en correspondencia con las de la abertura (2) a la cual está destinada a cerrar,  a closure (4) of geometry and dimensions corresponding to those of the opening (2) to which it is intended to close,
un casquillo (7) definido en el cuerpo del cierre (4) para conexión del interior del recipiente (1) con la atmósfera exterior,  a bushing (7) defined in the body of the closure (4) for connection of the inside of the container (1) with the outside atmosphere,
una bolsa (8) que encierra un elemento activador, albergada en el extremo del casquillo (7) próximo al interior del recipiente (1),  a bag (8) enclosing an activating element, housed at the end of the bushing (7) near the inside of the container (1),
una cazoleta (12), situada inferiormente a la bolsa (8) y próxima al extremo superior del recipiente (1), de geometría y dimensiones similares a las del interior de dicho recipiente (1), estando adicionalmente dotada dicha cazoleta a bowl (12), located inferiorly to the bag (8) and close to the upper end of the container (1), of similar geometry and dimensions to the interior of said container (1), said bowl being additionally provided
(12) de una pluralidad de aberturas (14) para intercambio de gases, y material reactivo (13) albergado en la cazoleta (12), para creación de una atmósfera anaerobia tras su activación por el elemento activador contenido en la bolsa (8), caracterizado por que el cierre (4) incorpora un tapón activador (6) que desplaza manualmente en el interior del casquillo (7) de dicho cierre (4), estando dicho tapón activador (6) dotado de un elemento punzante (11) para incidir y liberar el elemento activador contenido en la bolsa (8) y su posterior interacción con el material reactivo (13) para creación de una atmósfera anaerobia por intercambio de gases a través de las aberturas (14) de la cazoleta (12). (12) of a plurality of openings (14) for gas exchange, and reactive material (13) housed in the bowl (12), for creating an anaerobic atmosphere after activation by the activating element contained in the bag (8) , characterized in that the closure (4) incorporates an activating cap (6) that moves manually inside the bush (7) of said closure (4), said activating cap (6) being provided with a puncture element (11) for incide and release the activating element contained in the bag (8) and its subsequent interaction with the reactive material (13) to create an anaerobic atmosphere by gas exchange through the openings (14) of the bowl (12).
2. Dispositivo de acuerdo con la reivindicación 1 caracterizado por que la abertura (2) incorpora una primera superficie roscada (3), y porque el cierre (4) incorpora una segunda superficie roscada (5) destinada a acoplarse roscadamente con la primera superficie roscada (3) de la abertura (2). 2. Device according to claim 1 characterized in that the opening (2) incorporates a first threaded surface (3), and because the closure (4) incorporates a second threaded surface (5) intended to engage threadedly with the first threaded surface (3) of the opening (2).
3. Dispositivo de acuerdo con cualquiera de las reivindicaciones anteriores caracterizado por que incorpora adicionalmente una primera junta (15) destinada a interponerse entre la primera superficie roscada (3) de la abertura (2) y la segunda superficie roscada (5) del cierre (4) para asegurar la estanqueidad del interior del recipiente (1). Device according to any of the preceding claims characterized in that it additionally incorporates a first gasket (15) intended to interpose between the first threaded surface (3) of the opening (2) and the second threaded surface (5) of the closure (4) to ensure the tightness of the inside of the container (1).
4. Dispositivo de acuerdo con cualquiera de las reivindicaciones anteriores caracterizado por que incorpora adicionalmente una segunda junta (16) destinada a disponerse en el extremo del casquillo (7) en contacto con la atmósfera exterior para asegurar la estanqueidad del interior del recipiente (1). 4. Device according to any of the preceding claims characterized in that it additionally incorporates a second gasket (16) intended to be disposed at the end of the bushing (7) in contact with the outside atmosphere to ensure the tightness of the interior of the container (1) .
5. Dispositivo de acuerdo con cualquiera de las reivindicaciones anteriores caracterizado por que el recipiente (1) tiene geometría cilindrica. 5. Device according to any of the preceding claims characterized in that the container (1) has cylindrical geometry.
6. Dispositivo de acuerdo con cualquiera de las reivindicaciones anteriores caracterizado por que la abertura (2) tiene geometría circular. 6. Device according to any of the preceding claims characterized in that the opening (2) has circular geometry.
7. Uso del dispositivo descrito en la reivindicación 1 para recogida y traslado de muestras en anaerobiosis. 7. Use of the device described in claim 1 for collection and transfer of samples in anaerobiosis.
8. Uso del dispositivo de acuerdo con la reivindicación 7, caracterizado por que las muestras comprenden heces. 8. Use of the device according to claim 7, characterized in that the samples comprise feces.
9. Uso del dispositivo de acuerdo con la reivindicación 8 caracterizado por que las heces son de origen humano. 9. Use of the device according to claim 8 characterized in that the feces are of human origin.
10. Uso del dispositivo de acuerdo con la reivindicación 8 caracterizado por que las heces son de origen animal. 10. Use of the device according to claim 8 characterized in that the feces are of animal origin.
PCT/ES2017/070087 2016-02-16 2017-02-15 Device for collecting and transferring samples in anaerobiosis WO2017140935A1 (en)

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