WO2023172119A1 - Vial and punch cap set to extend the shelf life of a vaccine and/or drug - Google Patents

Vial and punch cap set to extend the shelf life of a vaccine and/or drug Download PDF

Info

Publication number
WO2023172119A1
WO2023172119A1 PCT/MX2022/050015 MX2022050015W WO2023172119A1 WO 2023172119 A1 WO2023172119 A1 WO 2023172119A1 MX 2022050015 W MX2022050015 W MX 2022050015W WO 2023172119 A1 WO2023172119 A1 WO 2023172119A1
Authority
WO
WIPO (PCT)
Prior art keywords
vial
cap
tip
vaccine
rubber
Prior art date
Application number
PCT/MX2022/050015
Other languages
Spanish (es)
French (fr)
Inventor
Héctor SILVA CASTRO
Original Assignee
Silva Castro Hector
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Silva Castro Hector filed Critical Silva Castro Hector
Priority to PCT/MX2022/050015 priority Critical patent/WO2023172119A1/en
Publication of WO2023172119A1 publication Critical patent/WO2023172119A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe

Definitions

  • the vials that are made up of a container with a resilient rubber stopper or with elastic memory, so that the liquid or powder content inside the vial is reached by introducing the needle through the rubber of the stopper, reaching the product. to be extracted, to later remove the needle and the rubber section closes the micro-opening created by the needle when introduced into the vial.
  • vials have been developed with caps made of other materials, which may have leachate migration towards the vaccine and/or medication, reacting with the active ingredient and reducing its effectiveness and shelf life, which is why the need was found. to develop a vial, in which there is no contact of the vaccine and/or medication with the materials and leachates of the cap until the moment it is applied.
  • a disinfectant cap and a manufacturing method which may include a first section and a second section, the first section may include a first plate, a container, a first seal, a second seal and a disinfectant agent, the second section may include a sleeve holder.
  • the container may include a second plate, a side wall and an inner chamber, the inner chamber and the side wall being positioned between the first plate and the second plate, the second section being adjacent to the second plate and opposite the first plate, and the first needle port and the second needle port are collinearly aligned with the sleeve holder.
  • GB1054586 relates to a closure for a container comprising a laminate of natural rubber with a solid polymer held in place by a sealing ring, wherein the layers can be joined together by adhesive or co-vulcanization and Closing discs can be cut from laminate sheets.
  • US2629379 relates to a vial stopper with a closure that clearly indicates puncture marks, which helps prevent coring by showing where previous punctures have occurred, comprising a self-sealing rubber stopper having a disc self-sealing without crowns laminated on top of it.
  • US6146362 discloses an injection system and a tipless drug transfer tip to facilitate attachment of a syringe to a fluid line.
  • the system has a casing and a partition consisting of only two parts.
  • the drug transfer tip has a positive locking member to restrict retraction of the injection site once it is inserted to inject a medication.
  • the positive locking member preferably comprises an annular rim defined around the axis of the drug transfer tip.
  • the septum includes a pair of oppositely oriented and axially aligned conical recesses with apices adjacent separated by a thin membrane or intersecting at the time of manufacture, the housing has an inlet for receiving the septum and comprises a plurality of fingers with tabs extending inwardly to hold the septum therein, the septum is ideally suited for application in injection sites, Y-connectors, vial adapters, single-dose or multi-dose vials and blood collection tubes.
  • the septum walls or inwardly extending tabs engage firmly with the shaft of the tip to prevent inadvertent removal.
  • leachates are generated under exaggerated conditions of temperature and time in the presence of an appropriate solvent, growing evidence suggests that leachates may represent a safety risk by causing toxicity, carcinogenicity, immunogenicity and/or endocrine deregulation, These substances can also alter the physical-chemical properties of the product through the interaction with the active pharmaceutical ingredient or the excipients in the product vehicle, which negatively affects the quality of the final product, it is for this reason that it is necessary to develop a container for medicines , more specifically for vaccines, that remains completely sealed and with the vaccine in contact with a single material until its use, and also that it contains multi-dose vaccines inside and that it is opened only when it is going to be used, but also that can incorporate a rubber stopper through which a needle can be inserted multiple times to extract a dose of the vaccine to be applied with each puncture.
  • An objective of the present invention is to provide a completely sealed vial with a vaccine or medication inside, so that the vaccine or medication remains in contact with a single material until the moment of use, extending the shelf life.
  • Another objective of the present invention is to provide an adapter or cap for the vial, which can be attached to the vial at the time the vaccine is to be extracted, where when the adapter or cap is attached to the vial, the tip of the vial penetrates. .
  • Another objective of the present invention is to provide an adapter or cap to the vial, which allows the insertion on several occasions of an extraction needle, so that the multi-dose contained in the vial can be extracted, said cap being attached at the time of extract the vaccine or medication, in this way the contact time of our injection site with the vaccine will only last while the vaccine is applied in a short time and the rubber (membrane) will only be in contact during the extraction of the vaccine which is a short time.
  • Figure 1 shows a side view where the syringe needle is inserted into the rubber of the adapter or cap.
  • Figure 2 shows a side view where the syringe needle, adapter or cap is inserted, not illustrating the rubber.
  • Figure 3 is a side sectional view of the adapter or plug without the rubber section.
  • Figure 4 is a side sectional view of the adapter or plug with rubber section.
  • Figure 5 represents a longitudinal section showing a side view of the completely sealed vial.
  • Figure 6 is a side section of the extraction cap being installed on the tip of the vial, showing the conical walls of the cap punch and the tip of the vial, showing the female angle on the inside of the vial that makes a seal with the male angle plug punch
  • the vial (13) is made up of a plastic container or container, preferably polyethylene or any polymer, hermetically closed, with the vaccine or multi-dose medication or injectable water (14) previously confined inside, said vial It has a neck with a straight tip (15), said straight tip (15) is closed by a thin wall (16) and has an external thread (17).
  • the adapter or extraction plug (1) is made up of a unitary plastic body that integrally defines a lower ring (6) with internal thread, an upper ring (4) and an intermediate transition section (9) between the upper ring ( 4) and the lower ring (6), where the upper ring (4) defines inside a chamber (2) where a rubber or drilling rubber (10) is housed, so that a needle can be inserted on multiple occasions. extraction (18).
  • the intermediate section (9) defines an inner diameter reduction, its upper walls are diagonal, forming a funnel-type conical portion (3) that ends in a through hole or extraction channel (5), said funnel helps direct the needle, From the center of the lower face of said intermediate section (9), a tubular punch (8) projected downwards defined by a metal or plastic tube with a diagonal or beveled tip (11), said bevel defining a punch tip, so that when this adapter or cap (1) is screwed into the external thread (17) of the tip of the vial (13), the tip (11) of the punch (8) is introduced into the vial (13), tearing the upper wall (16). ) thin of the vial (13), said punch (8) projects beyond the height of the edge of the lower ring (6) protruding from said ring (6).
  • Said vial adapter or cap (1) has a resilient rubber (10) with elastic memory, so that once the extraction cap (1) is placed on the vial (13), this rubber (10) remains attached to the vial. vial until all predetermined vaccine doses that have been previously packaged in the vial have been removed.
  • the medication or vaccine (14) already comes into contact with the materials of the cap (1) but for a period of very short time, only while the doses are extracted and applied, so the vaccine or medication or injectable water, since it is not in contact for a long time with other materials other than the material with which the vial is manufactured, does not undergo decomposition. , nor are leachables generated, nor alterations that could affect its effectiveness.
  • the walls of the punch (8) have a slight inclination or conicity (20) of preferably 6 o and the interior walls of the tip (15) of the vial (13) have the same inclination or conicity of 6 or (21), in this way when the adapter (1) is assembled to the vial (13), this taper allows a firmer fit or union.
  • the vial (13) is taken and the adapter or cap (1) is screwed on, as the adapter or cap (1) is screwed onto the tip of the vial.
  • the beveled tip (11) is introduced into the tip (15) of the vial, tearing or breaking the wall (16), introducing the punch (8) into the tip of the vial (13), leaving the rubber or rubber (10) firmly attached to the vial (13), to subsequently introduce the needle (18) of a syringe (19) through the rubber portion (10) extracting the predetermined amount of a dose by removing the needle (18), to subsequently repeat this operation until all the doses are extracted from the vial (13).

Abstract

The invention relates to a vial with a bevelled extraction cap that can be coupled at the moment of use, wherein the vial consists of a fully sealed container so that the vaccines, for example against COVID-19, or drug contained therein is in contact with a single material, preventing the extractable or leachable substances in a second material from migrating during the shelf life and thus affecting the properties of the injectable drug or vaccine or water. In addition, the adapter or cap has an integrated punch, such that when a dose of the drug or vial must be administered, the adapter or cap is screwed onto the vial, and as the adapter or cap is screwed on the tip of the vial, the bevelled tip is inserted into the tip of the vial, tearing or breaking the wall, the punch being inserted into the tip of the vial. The gum or rubber is firmly joined to the vial in order to subsequently insert the needle of a syringe through the rubber or gum portion and extract the predetermined amount of a dose, removing the needle to subsequently repeat this operation until all the doses have been extracted from the vial.

Description

CONJUNTO DE VIAL Y TAPON PUNZON PARA ALARGAR LA VIDA DE ANAQUEL DE UNA VACUNA Y/O MEDICAMENTO VIAL AND PUNCH CAP SET TO EXTEND THE SHELF LIFE OF A VACCINE AND/OR MEDICINE
ANTECEDENTES BACKGROUND
En la actualidad para suministrar un medicamento o una vacuna a un paciente por medio de una aguja y jeringa, por ejemplo, esta es envasada en una ampolleta de cristal o en un vial de plástico en el caso de ampolletas de vidrio estas presentan una sección rompible por medio de líneas de debilitamiento definiendo una abertura de acceso para introducir la aguja de la jeringa y extraer el contenido de la ampolleta. Currently, to deliver a medication or a vaccine to a patient by means of a needle and syringe, for example, it is packaged in a glass vial or in a plastic vial. In the case of glass vials, these have a breakable section. by means of weakening lines defining an access opening to introduce the syringe needle and extract the contents of the vial.
Otro de los dispositivos empleados son los viales que están conformados por un contenedor con un tapón de goma resiliente o con memoria elástica, de manera que el contenido liquido o en polvo dentro del vial se alcanza introduciendo la aguja por la goma del tapón alcanzando el producto a extraer, para posteriormente sacar la aguja y la sección de goma cierra la microabertura creada por la aguja al introducirse en el vial. Another of the devices used are the vials that are made up of a container with a resilient rubber stopper or with elastic memory, so that the liquid or powder content inside the vial is reached by introducing the needle through the rubber of the stopper, reaching the product. to be extracted, to later remove the needle and the rubber section closes the micro-opening created by the needle when introduced into the vial.
Actualmente, debido a la escasez del borosilicato, siendo esté, el material más usado para la fabricación de viales, y a la creciente demanda de contenedores inhertes para contener vacunas ej. Covid , se han desarrollado viales con tapones fabricados en otros materiales, los cuales pueden tener migración de lixiviadles hacia la vacuna y/o medicamento, reaccionando con el activo y disminuyendo su eficacia y su vida de anaquel, es por esto que se encontró la necesidad de desarrollar un vial, en el cual no exista contacto de la vacuna y/o medicamento con los materiales y lixiviadles del tapón hasta el momento en que se aplicara. Currently, due to the shortage of borosilicate, which is the most used material for the manufacture of vials, and the growing demand for inert containers to contain vaccines, e.g. Covid, vials have been developed with caps made of other materials, which may have leachate migration towards the vaccine and/or medication, reacting with the active ingredient and reducing its effectiveness and shelf life, which is why the need was found. to develop a vial, in which there is no contact of the vaccine and/or medication with the materials and leachates of the cap until the moment it is applied.
Un ejemplo de estos tipos de viales es divulgado en el documento US2019047756, el cual se refiere a un tapón desinfectante y un método de fabricación, que puede incluir una primera sección y una segunda sección, la primera sección puede incluir una primera placa, un recipiente, un primer sello, un segundo sello y un agente desinfectante, la segunda sección puede incluir un soporte de manga. El recipiente puede incluir una segunda placa, una pared lateral y una cámara interior, estando la cámara interior y la pared lateral colocadas entre la primera placa y la segunda placa, siendo la segunda sección adyacente a la segunda placa y opuesta a la primera placa, y el primer puerto de la aguja y el segundo puerto de la aguja están alineados colinealmente con el soporte del manguito. An example of these types of vials is disclosed in document US2019047756, which refers to a disinfectant cap and a manufacturing method, which may include a first section and a second section, the first section may include a first plate, a container, a first seal, a second seal and a disinfectant agent, the second section may include a sleeve holder. The container may include a second plate, a side wall and an inner chamber, the inner chamber and the side wall being positioned between the first plate and the second plate, the second section being adjacent to the second plate and opposite the first plate, and the first needle port and the second needle port are collinearly aligned with the sleeve holder.
El documento GB1054586 se refiere a un cierre para un recipiente que comprende un laminado de caucho natural con un polímero sólido que se mantiene en su lugar mediante un anillo de sellado, en donde las capas se pueden unir entre sí mediante adhesivo o co- vulcanización y los discos de cierre se pueden cortar de hojas del laminado. GB1054586 relates to a closure for a container comprising a laminate of natural rubber with a solid polymer held in place by a sealing ring, wherein the layers can be joined together by adhesive or co-vulcanization and Closing discs can be cut from laminate sheets.
El documento US2629379 se refiere a un tapón de vial con un cierre que indica claramente las marcas de pinchazos, lo que ayuda a prevenir la extracción de núcleos al mostrar dónde se han producido los pinchazos anteriores, comprende un tapón de caucho autosellante que tiene un disco auto sellante sin coronas laminado en la parte superior del mismo. US2629379 relates to a vial stopper with a closure that clearly indicates puncture marks, which helps prevent coring by showing where previous punctures have occurred, comprising a self-sealing rubber stopper having a disc self-sealing without crowns laminated on top of it.
El documento US6146362 divulga un sistema de inyección y una punta de transferencia de fármaco sin punta para facilitar el acoplamiento de una jeringa a una línea de fluido. El sistema tiene una carcasa y un tabique que consta de solo dos partes. La punta de transferencia de fármaco tiene un miembro de bloqueo positivo para restringir la retracción del sitio de inyección una vez que se inserta para inyectar un medicamento. El miembro de bloqueo positivo comprende preferiblemente un reborde anular definido alrededor del eje de la punta de transferencia de fármaco. El tabique incluye un par de recesos cónicos orientados de manera opuesta y alineados axialmente con ápices adyacentes separados por una membrana delgada o que se cruzan en el momento de la fabricación, el alojamiento tiene una entrada para recibir el tabique y comprende una pluralidad de dedos con lengüetas que se extienden hacia dentro para sujetar el tabique en su interior, el tabique está idealmente adaptado para su aplicación en lugares de inyección, conectores en Y, adaptadores de viales, viales monodosis o multidosis y tubos de extracción de sangre. Cuando se hace que la punta de transferencia de fármaco penetre en el tabique, las paredes del tabique o las lengüetas que se extienden hacia dentro se acoplan firmemente al eje de la punta para evitar una extracción inadvertida. US6146362 discloses an injection system and a tipless drug transfer tip to facilitate attachment of a syringe to a fluid line. The system has a casing and a partition consisting of only two parts. The drug transfer tip has a positive locking member to restrict retraction of the injection site once it is inserted to inject a medication. The positive locking member preferably comprises an annular rim defined around the axis of the drug transfer tip. The septum includes a pair of oppositely oriented and axially aligned conical recesses with apices adjacent separated by a thin membrane or intersecting at the time of manufacture, the housing has an inlet for receiving the septum and comprises a plurality of fingers with tabs extending inwardly to hold the septum therein, the septum is ideally suited for application in injection sites, Y-connectors, vial adapters, single-dose or multi-dose vials and blood collection tubes. When the drug transfer tip is forced into the septum, the septum walls or inwardly extending tabs engage firmly with the shaft of the tip to prevent inadvertent removal.
Este tipo de contenedores o viales presentan varios problemas como por ejemplo contener una única dosis del medicamento o vacuna y poner en contacto por un tiempo prolongado la vacuna o medicamento con varios materiales como el cuerpo del vial, el borde de la tapa y la porción de goma, y debido a que esta porción de goma muchas veces contiene aditivos para favorecer la elongación de dichas gomas que hacen el sello múltiple y estos aditivos o la goma en si puede reaccionar y bajar la caducidad o eficiencia de la vacuna o medicamento, por lo mismo es importante evitar el contacto de la vacuna o medicamento con varios materiales durante la vida de anaquel, lo cual representa un gran problema porque vacunas recientes, como por ejemplo, las empleadas para el COVID19 son muy reactivas a ciertos materiales e incluso se desconoce aún si hay reacción con alguno de los materiales que se utilizan en la actualidad para el envasado de las vacunas, lo que podría afectar la eficiencia de la vacuna, como por ejemplo los lixiviadles que son entidades químicas que migran espontáneamente desde el sistema de cierre del contenedor final, los componentes de empaque y / o el equipo de procesamiento bajo las condiciones recomendadas de uso y almacenamiento del producto. A diferencia de los lixiviadles, los extraíbles se generan bajo condiciones exageradas de temperatura y tiempo en presencia de un solvente apropiado, la creciente evidencia sugiere que los lixiviadles pueden representar un riesgo de seguridad al causar toxicidad, carcinogenicidad, inmunogenicidad y / o desregulación endocrina, estas sustancias también pueden alterar las propiedades físico-químicas del producto a través de la interacción con el ingrediente farmacéutico activo o los excipientes en el vehículo del producto, lo que afecta negativamente a la calidad del producto final, es por esta razón que se hace necesario desarrollar un envase para medicamentos, más específicamente para vacunas, que permanezca completamente sellado y con la vacuna en contacto con un solo material hasta su uso, y además que contenga multi-dosis de vacunas en su interior y que sea abierto únicamente cuando se va a utilizar, pero además que pueda incorporar un tapón de goma a través del cual pueda introducirse una aguja múltiples veces para extraer en cada pinchazo una dosis de la vacuna a aplicar. These types of containers or vials present several problems, such as containing a single dose of the medication or vaccine and putting the vaccine or medication in contact for a prolonged time with various materials such as the body of the vial, the edge of the lid and the portion of the lid. rubber, and because this portion of rubber often contains additives to promote the elongation of said rubbers that make the multiple seal and these additives or the rubber itself can react and lower the expiration or efficiency of the vaccine or medication, therefore It is also important to avoid contact of the vaccine or medication with various materials during the shelf life, which represents a big problem because recent vaccines, such as those used for COVID19, are very reactive to certain materials and are even unknown. if there is a reaction with any of the materials currently used for vaccine packaging, which could affect the efficiency of the vaccine, such as leachates, which are chemical entities that spontaneously migrate from the container closure system. final product, packaging components and/or processing equipment under the recommended conditions of use and storage of the product. Unlike leachates, extractables are generated under exaggerated conditions of temperature and time in the presence of an appropriate solvent, growing evidence suggests that leachates may represent a safety risk by causing toxicity, carcinogenicity, immunogenicity and/or endocrine deregulation, These substances can also alter the physical-chemical properties of the product through the interaction with the active pharmaceutical ingredient or the excipients in the product vehicle, which negatively affects the quality of the final product, it is for this reason that it is necessary to develop a container for medicines , more specifically for vaccines, that remains completely sealed and with the vaccine in contact with a single material until its use, and also that it contains multi-dose vaccines inside and that it is opened only when it is going to be used, but also that can incorporate a rubber stopper through which a needle can be inserted multiple times to extract a dose of the vaccine to be applied with each puncture.
Un objetivo de la presente invención es proporcionar un vial completamente sellado con una vacuna o medicamento en su interior, de manera que la vacuna o medicamento permanezca en contacto con un solo material hasta el momento de su uso, alargando la vida útil de anaquel. An objective of the present invention is to provide a completely sealed vial with a vaccine or medication inside, so that the vaccine or medication remains in contact with a single material until the moment of use, extending the shelf life.
Otro objetivo de la presente invención consiste en proporcionar un adaptador o tapón para el vial, el cual pueda acoplarse al vial en el momento en que se va a extraer la vacuna, en donde al acoplarse el adaptador o tapón al vial penetre la punta del vial. Another objective of the present invention is to provide an adapter or cap for the vial, which can be attached to the vial at the time the vaccine is to be extracted, where when the adapter or cap is attached to the vial, the tip of the vial penetrates. .
Otro objetivo de la presente invención consiste en proporcionar un adaptador o tapón al vial, que permita la inserción en varias ocasiones de una aguja de extracción, para que pueda extraer las multi-dosis contenidas en el vial, siendo dicho tapón acoplado en el momento de extraer la vacuna o medicamento, de esta manera el tiempo de contacto de nuestro sitio de inyección con la vacuna solo va a durar mientras se aplica la vacuna en un corto tiempo y la goma (membrana) solo estará en contacto durante la extracción de la vacuna que es un corto tiempo. BREVE DESCRIPCION DE LAS FIGURAS Another objective of the present invention is to provide an adapter or cap to the vial, which allows the insertion on several occasions of an extraction needle, so that the multi-dose contained in the vial can be extracted, said cap being attached at the time of extract the vaccine or medication, in this way the contact time of our injection site with the vaccine will only last while the vaccine is applied in a short time and the rubber (membrane) will only be in contact during the extraction of the vaccine which is a short time. BRIEF DESCRIPTION OF THE FIGURES
La figura 1 muestra una vista lateral en donde se inserta la aguja de la jeringa en la goma del adaptador o tapón. Figure 1 shows a side view where the syringe needle is inserted into the rubber of the adapter or cap.
La figura 2 muestra una vista lateral en donde se inserta la aguja de la jeringa el adaptador o tapón, no ilustrando la goma. Figure 2 shows a side view where the syringe needle, adapter or cap is inserted, not illustrating the rubber.
La figura 3 es una vista en corte lateral del adaptador o tapón sin la sección de goma. Figure 3 is a side sectional view of the adapter or plug without the rubber section.
La figura 4 es una vista en corte lateral del adaptador o tapón con sección de goma. Figure 4 is a side sectional view of the adapter or plug with rubber section.
La figura 5 representa un corte longitudinal mostrando una vista lateral del vial sellado completamente. Figure 5 represents a longitudinal section showing a side view of the completely sealed vial.
La figura 6 es un corte lateral del tapón de extracción instalándose en la punta del vial, mostrando las paredes cónicas del punzón del tapón y de la punta del vial, mostrando el ángulo hembra en la parte interna del vial que hace sello con el ángulo macho del punzón del tapón Figure 6 is a side section of the extraction cap being installed on the tip of the vial, showing the conical walls of the cap punch and the tip of the vial, showing the female angle on the inside of the vial that makes a seal with the male angle plug punch
DESCRIPCION DETALLADA DETAILED DESCRIPTION
El vial (13) está constituido de un envase o contenedor de plástico preferentemente polietileno o cualquier polímero, cerrado herméticamente, con la vacuna o medicamento multi-dosis o agua inyectable (14) confinado en su interior previamente, dicho vial presenta un cuello con terminación en punta recta (15), dicha punta recta (15) está cerrada por una pared delgada (16) y cuenta con una rosca exterior (17). The vial (13) is made up of a plastic container or container, preferably polyethylene or any polymer, hermetically closed, with the vaccine or multi-dose medication or injectable water (14) previously confined inside, said vial It has a neck with a straight tip (15), said straight tip (15) is closed by a thin wall (16) and has an external thread (17).
El adaptador o tapón de extracción (1) está constituido de un cuerpo de plástico unitario que define integralmente un anillo inferior (6) con rosca interna, un anillo superior (4) y una sección intermedia (9) de transición entre el anillo superior (4) y el anillo inferior (6), en donde el anillo superior (4) define en su interior una cámara (2) en donde se aloja una goma o caucho de perforación (10), para que pueda insertarse en múltiples ocasiones una aguja de extracción (18). The adapter or extraction plug (1) is made up of a unitary plastic body that integrally defines a lower ring (6) with internal thread, an upper ring (4) and an intermediate transition section (9) between the upper ring ( 4) and the lower ring (6), where the upper ring (4) defines inside a chamber (2) where a rubber or drilling rubber (10) is housed, so that a needle can be inserted on multiple occasions. extraction (18).
La sección intermedia (9) define una reducción de diámetro interior, presenta sus paredes superiores en diagonal formando una porción cónica (3) tipo embudo que termina en un orificio pasado o canal de extracción (5), dicho embudo ayuda a dirigir la aguja, del centro de la cara inferior de dicha sección intermedia (9) se proyecta hacia abajo un punzón tubular (8) definido por un tubo de metal o plástico con punta en diagonal o biselada (11) definiendo dicho bisel una punta de punzón, de manera que al enroscarse este adaptador o tapón (1) en la rosca externa (17) de la punta del vial (13) se va introduciendo la punta (11) del punzón (8) dentro del vial (13) rasgando la pared superior (16) delgada del vial (13), dicho punzón (8) se proyecta más allá de la altura del borde del anillo inferior (6) sobresaliendo de dicho anillo (6). The intermediate section (9) defines an inner diameter reduction, its upper walls are diagonal, forming a funnel-type conical portion (3) that ends in a through hole or extraction channel (5), said funnel helps direct the needle, From the center of the lower face of said intermediate section (9), a tubular punch (8) projected downwards defined by a metal or plastic tube with a diagonal or beveled tip (11), said bevel defining a punch tip, so that when this adapter or cap (1) is screwed into the external thread (17) of the tip of the vial (13), the tip (11) of the punch (8) is introduced into the vial (13), tearing the upper wall (16). ) thin of the vial (13), said punch (8) projects beyond the height of the edge of the lower ring (6) protruding from said ring (6).
Dicho adaptador o tapón (1) de vial cuenta con una goma o caucho resilente (10) con memoria elástica, de manera que una vez colocada la tapa de extracción (1) en el vial (13) esta goma (10) permanece unida al vial hasta que se hallan extraído todas las dosis de vacuna predeterminadas que se han envasado previamente en el vial. Said vial adapter or cap (1) has a resilient rubber (10) with elastic memory, so that once the extraction cap (1) is placed on the vial (13), this rubber (10) remains attached to the vial. vial until all predetermined vaccine doses that have been previously packaged in the vial have been removed.
Una vez colocado el adaptador o tapón (1) de extracción en el vial (13), el medicamento o vacuna (14) ya entra en contacto con los materiales del tapón (1) pero por un periodo de tiempo muy corto, únicamente mientras se van extrayendo las dosis y se van aplicando, por lo que la vacuna o medicamento o agua inyectable, al no estar mucho tiempo en contacto con otros materiales distintos del material con el que el vial es fabricado no sufre descomposición, ni se generan lixivia bles, ni alteraciones que puedan afectar su eficacia. Once the adapter or extraction cap (1) is placed in the vial (13), the medication or vaccine (14) already comes into contact with the materials of the cap (1) but for a period of very short time, only while the doses are extracted and applied, so the vaccine or medication or injectable water, since it is not in contact for a long time with other materials other than the material with which the vial is manufactured, does not undergo decomposition. , nor are leachables generated, nor alterations that could affect its effectiveness.
En una modalidad de la presente invención, las paredes del punzón (8) presentan una ligera inclinación o conicidad (20) de preferentemente 6o y las paredes interiores de la punta (15) del vial (13) presentan la misma inclinación o conicidad de 6o (21), de esta manera al ensamblarse el adaptador (1) al vial (13), esta conicidad permite un encaje o unión más firme. In one embodiment of the present invention, the walls of the punch (8) have a slight inclination or conicity (20) of preferably 6 o and the interior walls of the tip (15) of the vial (13) have the same inclination or conicity of 6 or (21), in this way when the adapter (1) is assembled to the vial (13), this taper allows a firmer fit or union.
De esta manera, al momento de requerir administrar dosis del medicamento o vial, se toma el vial (13) y se enrosca el adaptador o tapón (1), a medida que el adaptador o tapón (1) se enrosca en la punta del vial (13), la punta biselada (11) se va introduciendo en la punta (15) del vial, rasgando o rompiendo la pared (16) introduciéndose el punzón (8) en la punta del vial (13), quedando la goma o caucho (10) firmemente unida al vial (13), para posteriormente introducir la aguja (18) de una jeringa (19) por la porción de goma o caucho (10) extrayendo la cantidad predeterminada de una dosis sacando la aguja (18), para posteriormente repetir esta operación hasta que se extraigan todas las dosis del vial (13). In this way, when a dose of the medication or vial is required to be administered, the vial (13) is taken and the adapter or cap (1) is screwed on, as the adapter or cap (1) is screwed onto the tip of the vial. (13), the beveled tip (11) is introduced into the tip (15) of the vial, tearing or breaking the wall (16), introducing the punch (8) into the tip of the vial (13), leaving the rubber or rubber (10) firmly attached to the vial (13), to subsequently introduce the needle (18) of a syringe (19) through the rubber portion (10) extracting the predetermined amount of a dose by removing the needle (18), to subsequently repeat this operation until all the doses are extracted from the vial (13).

Claims

REIVINDICACIONES Habiendo descrito mi invención como antecede, considero una novedad y reclamo de mi propiedad lo contenido en las siguientes cláusulas: CLAIMS Having described my invention as above, I consider the contents of the following clauses to be novel and claim my ownership:
1. -Conjunto de vial y tapón biselado de extracción acoplable constituido por: un envase o contenedor de plástico cerrado herméticamente con la vacuna o medicamento o agua inyectable multi-dosis (14) confinado en su interior previamente, de manera que dicha vacuna y/o medicamento únicamente está en contacto con un solo material del envase durante su vida de anaquel, hasta el momento en que se va a administrar punzonando el contenedor con el tapón biselado de extracción, dicho vial presenta un cuello con terminación (15), dicha terminación (15) está cerrada por una pared delgada (16) y cuenta con una rosca exterior (17); Un adaptador o tapón de extracción (1) constituido por un cuerpo de plástico que define integralmente un anillo inferior (6) con rosca interna, un anillo superior (4) y una sección intermedia (9) de transición entre el anillo superior (4) y el anillo inferior (6), en donde el anillo superior (4) define en su interior una cámara (2) en donde se aloja una goma o caucho de perforación (10), para que pueda insertarse en múltiples ocasiones una aguja de extracción (18), la sección intermedia (9) define una reducción de diámetro interior, presenta sus paredes superiores en diagonal formando una porción cónica (3) tipo embudo que termina en un orificio pasado o canal de extracción (5), del centro de la cara inferior de dicha sección intermedia (9) se proyecta hacia abajo un punzón tubular (8), integral al cuerpo de plástico unitario, definido por un tubo de plástico con punta en diagonal o biselada (11) definiendo dicho bisel una punta de punzón, de manera que al enroscarse este adaptador o tapón (1) en la rosca externa (17) de la punta del vial (13) se va introduciendo la punta (11) del punzón (8) dentro del vial (13) rasgando la pared superior (16) delgada del vial (13), dicho punzón (8) se proyecta más allá de la altura del borde del anillo inferior (6) sobresaliendo de dicho anillo (6). 1. -Set of vial and bevelled extraction cap consisting of: a hermetically closed plastic container or container with the multi-dose injectable vaccine or medication or water (14) previously confined inside, so that said vaccine and/or or medication is only in contact with a single material of the container during its shelf life, until the moment in which it is going to be administered by punching the container with the bevelled extraction cap, said vial has a neck with a termination (15), said termination (15) is closed by a thin wall (16) and has an external thread (17); An adapter or extraction cap (1) consisting of a plastic body that integrally defines a lower ring (6) with internal thread, an upper ring (4) and an intermediate transition section (9) between the upper ring (4) and the lower ring (6), where the upper ring (4) defines inside a chamber (2) where a rubber or drilling rubber (10) is housed, so that an extraction needle can be inserted on multiple occasions. (18), the intermediate section (9) defines a reduction in internal diameter, its upper walls are diagonal, forming a conical portion (3) type of funnel that ends in a through hole or extraction channel (5), in the center of the lower face of said intermediate section (9), a tubular punch (8) projects downwards, integral to the unitary plastic body, defined by a plastic tube with a diagonal or beveled tip (11), said bevel defining a punch tip, so that when this adapter or cap (1) is screwed into the external thread (17) of the tip of the vial (13), the tip (11) of the punch (8) is introduced into the vial. (13) tearing the thin upper wall (16) of the vial (13), said punch (8) projects beyond the height of the edge of the lower ring (6) protruding from said ring (6).
2. -Conjunto de vial y tapón biselado de extracción acoplable, de acuerdo a la reivindicación 1, en donde la goma o caucho resilente (10) con memoria elástica, una vez colocada la tapa de extracción (1) en el vial (13) en el momento de la aplicación o uso, esta goma (10) permanece unida al vial hasta que se hallan extraído todas las dosis de vacuna y/o medicamento y/o agua inyectada predeterminadas que se han envasado previamente en el vial. 2. -Assembly of vial and attachable extraction beveled cap, according to claim 1, wherein the rubber or resilient rubber (10) with elastic memory, once the extraction cap (1) is placed in the vial (13) At the time of application or use, this rubber (10) remains attached to the vial until all predetermined doses of vaccine and/or medication and/or injected water that have been previously packaged in the vial have been extracted.
3. -Conjunto de vial y tapón biselado de extracción acoplable, de acuerdo a la reivindicación 1, en donde una vez colocado el adaptador o tapón (1) de extracción en el vial (13), el medicamento o vacuna o agua inyectable (14) ya entra en contacto con los materiales del tapón (1) pero por un periodo de tiempo muy corto, únicamente mientras se van extrayendo las dosis y se van aplicando, evitando que los extraíbles o lixiviadles que existen en un segundo material migren durante la vida de anaquel afectando las propiedades del medicamento o vacuna o agua inyectable. 3. - Assembly of vial and bevelled extraction cap, according to claim 1, wherein once the adapter or extraction cap (1) is placed in the vial (13), the medicine or vaccine or injectable water (14) ) already comes into contact with the materials of the cap (1) but for a very short period of time, only while the doses are extracted and applied, preventing the extractables or leachables that exist in a second material from migrating during its life. shelf affecting the properties of the medicine or vaccine or injectable water.
4. -Conjunto de vial y tapón biselado de extracción acoplable, de acuerdo a la reivindicación 1, en donde las paredes del punzón (8) presentan una ligera inclinación o conicidad (20) de preferentemente 6o y las paredes interiores de la punta (15) del vial (13) presentan la misma inclinación o conicidad de 6o (21), de esta manera al ensamblarse el adaptador (1) al vial (13), esta conicidad permite un encaje o unión más firme. 4. - Assembly of vial and bevelled extraction cap, according to claim 1, wherein the walls of the punch (8) have a slight inclination or conicity (20) of preferably 6 o and the interior walls of the tip ( 15) of the vial (13) have the same inclination or conicity of 6 o (21), in this way when the adapter (1) is assembled to the vial (13), this conicity allows a firmer fit or union.
PCT/MX2022/050015 2022-03-09 2022-03-09 Vial and punch cap set to extend the shelf life of a vaccine and/or drug WO2023172119A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/MX2022/050015 WO2023172119A1 (en) 2022-03-09 2022-03-09 Vial and punch cap set to extend the shelf life of a vaccine and/or drug

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/MX2022/050015 WO2023172119A1 (en) 2022-03-09 2022-03-09 Vial and punch cap set to extend the shelf life of a vaccine and/or drug

Publications (1)

Publication Number Publication Date
WO2023172119A1 true WO2023172119A1 (en) 2023-09-14

Family

ID=87935574

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/MX2022/050015 WO2023172119A1 (en) 2022-03-09 2022-03-09 Vial and punch cap set to extend the shelf life of a vaccine and/or drug

Country Status (1)

Country Link
WO (1) WO2023172119A1 (en)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4650475A (en) * 1985-07-18 1987-03-17 Carol Smith Method and apparatus for the injection of pharmaceuticals
US20040210207A1 (en) * 2001-06-20 2004-10-21 Shai Amisar Safety dispensing system and method
US20180161243A1 (en) * 2016-12-13 2018-06-14 Shire Modular vial adapter
US20190217015A1 (en) * 2018-01-12 2019-07-18 Becton, Dickinson And Company Smart Vial Adapter and Method
WO2021022326A1 (en) * 2019-08-03 2021-02-11 Noble House Group Pty. Ltd. Subculture sampling device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4650475A (en) * 1985-07-18 1987-03-17 Carol Smith Method and apparatus for the injection of pharmaceuticals
US20040210207A1 (en) * 2001-06-20 2004-10-21 Shai Amisar Safety dispensing system and method
US20180161243A1 (en) * 2016-12-13 2018-06-14 Shire Modular vial adapter
US20190217015A1 (en) * 2018-01-12 2019-07-18 Becton, Dickinson And Company Smart Vial Adapter and Method
WO2021022326A1 (en) * 2019-08-03 2021-02-11 Noble House Group Pty. Ltd. Subculture sampling device

Similar Documents

Publication Publication Date Title
ES2252828T3 (en) PENETRATOR ELEMENT FOR COVER ASSEMBLY FOR CONTAINER AND PROCEDURE FOR MANUFACTURING.
JP7132185B2 (en) Medical vial access device with pressure equalization and closed drug delivery system
ES2912467T3 (en) Closed fluid transfer system
US20210331824A1 (en) Piercing Member for Container Access Device
ES2405262T3 (en) Connector for containers containing medicinal liquids and container for medicinal liquids
ES2379121T3 (en) PRESSURE COMPENSATION DEVICE FOR ROAD ACCESS.
ES2446972T3 (en) Fluid transfer devices with sealing arrangement
US6568439B1 (en) Container cap and liquid communication adapter
ES2634011T3 (en) Protective cap
ES2743452T3 (en) System with adapter for closed fluid transfer
EP2190401B1 (en) Device, sealing member and fluid container
ES2550769T3 (en) System to facilitate a reconstitution by a user
ES2711169T3 (en) Ampoule for a medical liquid and procedure for the manufacture of a blister
ES2421145T3 (en) Access path with safety tab and fluid container that includes it
ES2708848T3 (en) Vial and vial adapters to regulate pressure
ES2208286T3 (en) SPRAY FOR THE CONDITIONING OF A LIQUID FOR MEDICAL USE.
CN106999346A (en) Container and closure member
EA034948B1 (en) Connecting and container system
BR112013019152B1 (en) connector
JPH09104461A (en) Re-sealable vial equipped with connector assmbly with film and pusher
JP2000237278A (en) Plug of container of drug having means of integrally inserting spike
ES2681032T3 (en) Adapter for multi-dose medical container
JP2022093521A (en) Protector housing plastic spike with flash intended for dvo last drop extraction
ES2674667T3 (en) Connector system for medical fluid administration
WO2023172119A1 (en) Vial and punch cap set to extend the shelf life of a vaccine and/or drug

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22931143

Country of ref document: EP

Kind code of ref document: A1