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WO2017001719A1 - Safety device for blood extraction - Google Patents

Safety device for blood extraction Download PDF

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Publication number
WO2017001719A1
WO2017001719A1 PCT/ES2016/070491 ES2016070491W WO2017001719A1 WO 2017001719 A1 WO2017001719 A1 WO 2017001719A1 ES 2016070491 W ES2016070491 W ES 2016070491W WO 2017001719 A1 WO2017001719 A1 WO 2017001719A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
hollow body
connector
mobile
retracted position
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/ES2016/070491
Other languages
Spanish (es)
French (fr)
Inventor
José Antonio GÓMEZ FERNÁNDEZ
Brígida PERAL BELCHIOR
Alberto TENORIO ABREU
Juan GÓMEZ SALGADO
Adolfo ROMERO RUIZ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Servicio Andaluz de Salud
Original Assignee
Servicio Andaluz de Salud
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 Servicio Andaluz de Salud filed Critical Servicio Andaluz de Salud
Publication of WO2017001719A1 publication Critical patent/WO2017001719A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/04—Access sites having pierceable self-sealing members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles

Definitions

  • the present invention pertains in general to the field of medicine, and more particularly to the devices used to draw blood from a patient.
  • the object of the present invention is a safety device specially designed to avoid the risk of punctures during blood extraction.
  • the fin extractor (100) is a product specifically designed for blood collection. It is a device formed by a needle (101) whose base is provided with a pair of flat fins (102) and from which a flexible conduit (103) for the passage of blood at whose proximal end is a needle (104).
  • Fig. 1a shows an example of fin extractor (100).
  • the adapter (200) consists essentially of a hollow body that has a fully open proximal end (200a) and a distal end (200b) at least partially closed and provided with a plugged hole with a tear-off membrane for needle engagement proximal
  • Fig. 1b shows an example of adapter (200).
  • the vacuum tube (300) is a tube with a soft plastic cap that allows a needle to pass through it by light pressure. The more known is the so-called "vacutainer, a trademark of Becton, Dickinson and Company.
  • Fig. 1 c shows an example of a vacuum tube (300) of the vacutainer type. Figs.
  • FIG. 2a-2d schematically show how these elements interconnect during a conventional extraction
  • the user connects the flexible tube (103) to the adapter (200)
  • the proximal needle (104) of the flexible tube (103) is inserted through the distal hole of the adapter (200), as shown in Fig. 2.
  • the proximal needle (104) protrudes inside the hollow body cavity of the adapter (200), as seen in Fig. 2b.
  • the vacuum tube (300) is introduced through the open proximal side (200a) of the adapter (200), as seen in Fig. 2c , until the proximal needle (104) passes through the cap of the vacuum tube (300).
  • Fig. 3 shows this set of elements already coupled together during an extraction process.
  • This system is, in general, practical and safe because it does not require needle handling.
  • the user is forced to disconnect the vacuum tube (300) from the adapter (200) and replace it by a syringe (400) that allows the extraction by manual pressure by pulling the plunger.
  • the user disconnects said syringe (400) from the adapter (200), connects an additional needle, and finishes filling the vacuum tube (300) by introducing said additional needle from the syringe (400) through the cap of the vacuum tube (300) and pressing the plunger of said syringe (400).
  • This whole process involves the manipulation of needles, so that errors and punctures can occur on the part of the user.
  • the present invention describes a novel device that allows a conventional extraction with a vacuum tube to be conveniently carried out, as well as carrying out the necessary operations for manual needle extraction if necessary, all without the need to manipulate needles.
  • the security device of the invention basically comprises a hollow body and a moving needle housed inside. Each of these elements is described in more detail below. a) Hollow body
  • the connector can be configured in different ways as long as it allows the connection of the tip of a syringe of the type conventionally used for blood collection.
  • it may be a female connector configured for the reception of the syringe tip or a male connector designed to be inserted through the orifice of said tip.
  • the connector comprises a conical hole intended for receiving the male luer connector that constitutes the tip of a conventional syringe.
  • the hole in the distal side of the hollow body must be of sufficient size to allow the passage of the moving needle.
  • the tear-off membrane is configured to essentially maintain the tightness when it is pierced by a needle for the reasons described below. For this, it can be made of any material that fulfills this function, such as paper, rubber or rubber.
  • the device is supplied with the needle in its retracted position to avoid any possibility of puncture by the user.
  • the needle base is connected to the connector in such a way that it allows blood drawn to the patient to pass through the needle in the direction of its base and from there it passes through the connector to the inside of a syringe connected to it, or either in the opposite direction from said syringe through the connector first and then the needle in the direction of a vacuum tube attached to the tip of said needle, as will be described in detail later in this document.
  • the needle can be configured in different ways as long as it allows its movement from the stowed position to the extended position. Some preferred embodiments are described below.
  • the needle of a conventional fin extractor is normally inserted into the patient's blood vessel.
  • the proximal needle of the flexible conduit of said fin extractor is inserted through the distal orifice of a conventional adapter and a vacuum tube is attached to said adapter so that said proximal needle passes through the vacuum tube cap.
  • the patient's blood is sucked through the flexible tube of the fin extractor as a result of the vacuum until it is deposited in the tube. So far, it is a conventional extraction procedure.
  • the user disconnects the vacuum tube from the adapter.
  • the device of the invention is introduced into the adapter until the proximal needle of the flexible duct extractor duct, which as mentioned above passes through the distal hole of the adapter and extends along its interior, passes through the tear hole membrane located on the distal side of the device of the invention.
  • a syringe is then connected to the connector on the proximal side of the device of the invention.
  • the user disconnects the device of the invention from the proximal needle of the flexible duct of the fin extractor and takes it out of the adapter.
  • it passes the mobile needle of the device from its retracted position to its extended position.
  • the moving needle protrudes externally through the hole located on the distal side of the hollow body.
  • the user then connects the device of the invention to the vacuum tube by causing the tip of said movable needle to pass through the cap of said vacuum tube. In this situation, there is a closed fluid connection between the syringe and the vacuum tube. The user pushes the syringe plunger to introduce the blood stored therein into the vacuum tube.
  • the device of the invention further comprises anchoring means configured to keep the moving needle in its retracted state and extension means configured to drive the moving needle from the retracted position to the extended position when they are released. the anchoring means.
  • the anchoring means can be implemented in different ways. For example, they can be formed by a lever that engages in a notch or needle cavity to prevent its displacement to the extended position. They can also consist of a sealing zone between the needle and the hollow body, so that an external pressure by a user causes the seal to break and the needle to be released. Or, a pair of flanges can be used respectively located on the needle and in the hollow body that cooperate with each other to prevent displacement of the needle except when a certain rotation of the needle is performed. There are a multitude of mechanisms designed for this purpose, mentioning by way of example those used in pens and devices for the application of insulin. An example of anchoring means is described in more detail below. As for the extension means, they preferably comprise a spring connected to the mobile needle that is pre-compressed when said needle is in the retracted position. Thus, when the anchoring means are released and the needle is released, the spring automatically drives it towards the extended position.
  • the mobile needle is telescopic. That is, the needle is formed by several cylindrical sections of slightly different diameters that are connected to each other so that, in the retracted position, each section is housed in the adjacent upper diameter section, while in the extended position the sections they only overlap in an area of the respective ends that hold them together.
  • the spring may be fixed between the tip of the movable needle and the connector, such that it causes the complete automatic extension of the needle when the anchoring means are released.
  • the movable needle and the connector constitute a single piece that is slidably coupled to the hollow body.
  • the passage of the needle from the retracted position to the extended position implies the sliding of said piece formed by needle and connector from a delayed initial position where the needle is completely inside the hollow body to a more advanced final position where the needle protrudes through the distal hole of the hollow body.
  • This sliding is produced by the spring, which in this case can be fixed between the moving needle and the proximal side of the hollow body.
  • the anchoring means preferably comprise at least a first flange located on the proximal side of the hollow body and a second flange located at the base of the movable needle. These two flanges cooperate with each other so that, in the retracted position, they prevent the longitudinal displacement of the part formed by the movable needle and the connector towards the extended position.
  • a relative rotation of said piece formed by the movable needle and the connector relative to the hollow body releases said piece allowing its passage from the retracted position to the extended position, which happens automatically due to the spring action.
  • the flanges can occupy only a part of the circumference of the needle and the hollow body, so that a turn of, for example, a quarter turn, releases the coupling between them and allows the sliding of the needle and connector distally by the force of the spring
  • Figs. 1 a-1 c show the different elements used in a conventional blood collection procedure according to the prior art.
  • Figs. 2a-2d illustrate the way in which the aforementioned elements of the prior art are connected to perform a conventional blood collection.
  • Fig. 3 shows the aforementioned elements of the prior art already connected during a conventional blood collection.
  • Figs. 4a and 4b show perspective views of a first configuration of the device of the present invention respectively with a telescopic needle in its retracted position and in its extended position.
  • Figs. 5a and 5b show longitudinal sections of the first configuration of the device of the invention respectively with the telescopic needle in its retracted position and in its extended position.
  • Figs. 6a and 6b show perspective views of a second configuration of the device of the present invention respectively with a movable needle in its retracted position and in its extended position.
  • Figs. 7a and 7b show longitudinal sections of the second configuration of the device of the invention respectively with the movable needle in its retracted position and in its extended position.
  • Fig. 8 shows the device of the invention according to the second configuration connected between a conventional syringe and a fin extractor for extraction of blood when the pressure of a vacuum tube is not enough.
  • Fig. 9 shows the device of the invention according to the second configuration connected between the conventional syringe and a vacuum tube to pass the blood previously drawn from the conventional syringe to the vacuum tube.
  • FIGs. 1-3 show the elements conventionally used in the prior art that have already been described in this document in the background section.
  • Figs. 4-5 show an example of device (1) according to a first configuration of the present invention where the needle (5) is telescopic.
  • the device (1) comprises a transparent hollow body (2) that houses the telescopic needle (5).
  • the hollow body (2) has an essentially cylindrical shape with a proximal side provided with a connector (3) and a distal side provided with a hole (4).
  • the distal side of the hollow body (2) narrows in the vicinity of the hole (4).
  • the hole (4) is covered by a tear-off membrane made of rubber.
  • the extensible needle (5) is formed by four telescopic sections that fit into each other.
  • the telescopic needle (5) is initially presented in a retracted position in which the tip (5b) is fully housed inside the hollow body (2), as seen in Figs. 4th and 5th.
  • the telescopic needle (5) can adopt an extended position in which it exits through the hole (4) on the distal side of the device (1), as shown in Figs. 4b and 5b.
  • a spring (6) fixed to the proximal side of the hollow body (2) and to the distal end (5b) of the needle (5) is arranged.
  • This spring (6) is in a pre-compressed position when the needle (5) is in the retracted position.
  • Anchoring means (not shown in the figures) keep the needle locked in this retracted position.
  • the base (5a) of the telescopic needle (5) is fixed to the inner face of the proximal side of the hollow body (2) in such a way that it is in fluid connection with the connector (3) fixed to the outer face of said proximal side of the body (2) hollow.
  • the connector (3) consists essentially of a cylindrical part equipped with a longitudinal frustoconical hole specially sized for coupling by pressing the male luer connector of a conventional syringe (400).
  • Figs. 6-7 show a second configuration of the device (1) of the invention similar to the first configuration except that the mobile needle (5) in this case is not telescopic. Therefore, a description of the similar elements is omitted here and the needle (5) and the extension and anchoring means are described in detail.
  • the needle (5) of this second configuration is attached to the connector (3) forming a single piece that moves in solidarity, and this piece is longitudinally slidably coupled to the hollow body (2).
  • this second configuration to move from the retracted position to the extended position, the entire piece formed by connector (3) and needle (5) is moved, as can be seen in Figs. 6 and 7.
  • a spring (6) is used having a first end fixed to the base of the hollow body (2) and a second end fixed to the moving needle (5).
  • the spring (6) In the retracted state, the spring (6) is pre-compressed, and anchoring means prevent the passage to the extended state.
  • the anchoring means When the anchoring means are released, the spring (6) drives the piece formed by connector (3) and needle (5), which thereby travels longitudinally distally to the extended position where the tip (5b) of the needle (5) protrudes through the hole (4) of the hollow body (2).
  • the anchoring means are not shown in this figure, although as mentioned above, a first flange located on the proximal side of the hollow body (2) and a second flange located at the base (5a) of the second configuration can be used in this second configuration.
  • needle (5) mobile.
  • These flanges can occupy, for example, 90 ° of the circumference of both elements.
  • Figs. 8 and 9 show an example of use of the device (1) of the invention according to the second configuration shown in Figs. 6-7.
  • a conventional extraction procedure is started as described in the background of this document.
  • the assembly used is shown in Fig. 3.
  • the device (1) of the invention is used.
  • the mobile needle (5) of the device (1) is in its retracted position.
  • the tube (300) of the needle (104) proximal to the fin extractor (100) is disengaged.
  • the device (1) is introduced into the adapter (200) such that the needle (104) is inserted through the hole (4), tearing the membrane.
  • the male luer end of a conventional syringe (400) is coupled to the connector (3) of the device (1).
  • the rubber tear-off membrane in this example maintains tightness, so that the depression created by the retraction of the syringe plunger (400) causes the patient's blood to flow through the flexible tube (103), pass through of the proximal needle (104) and the mobile needle (5), and finally pass through the connector (3) until it reaches the inside of the syringe (400).
  • the start of this operation is shown in Fig. 6.
  • the syringe (400) and the device (1) of the adapter (200) are removed, such that the proximal needle (104) exits through the hole ( 4).
  • the anchoring means of the device (1) are released to make the moving needle (5) pass from its retracted position to its extended position.
  • a rotation of the part formed by the connector (3) and the moving needle (5) of 90 ° in relation to the hollow body (2) that releases the coupling between the corresponding flanges is performed.
  • the displacement towards the extended position then occurs automatically thanks to the spring (6).
  • the tip (5b) of the needle (5) which protrudes through the hole (4) of the hollow body (2), is inserted through the cap of the vacuum tube (300) that had begun to be used at the beginning of the conventional extraction procedure, and the syringe plunger (400) is pressed to make the blood stored in said syringe (400) finally pass into said tube (300).

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Abstract

Disclosed is a safety device (1) for performing blood extraction, comprising: a hollow body (2) that has a connector (3) for a syringe at the proximal end thereof, and a hole (4) at the distal end thereof, the hole (4) being covered by a tearable membrane; and a movable needle (5) that has a base (5a) connected to the connector (3), and a point (5b), wherein the movable needle (5) can be moved from a retracted position in which the point (5b) is inside the hollow body (2) to an extended position in which the point (5b) protrudes through the hole (4) of the hollow body.

Description

DISPOSITIVO DE SEGURIDAD PARA EXTRACCIONES SANGUÍNEAS  SAFETY DEVICE FOR BLOOD EXTRACTIONS

DESCRIPCIÓN  DESCRIPTION

OBJETO DE LA INVENCIÓN OBJECT OF THE INVENTION

La presente invención pertenece en general al campo de la medicina, y más particularmente a los dispositivos empleados para la extracción de sangre de un paciente. El objeto de la presente invención es un dispositivo de seguridad especialmente diseñado para evitar el riesgo de pinchazos durante la realización de extracciones sanguíneas. The present invention pertains in general to the field of medicine, and more particularly to the devices used to draw blood from a patient. The object of the present invention is a safety device specially designed to avoid the risk of punctures during blood extraction.

ANTECEDENTES DE LA INVENCIÓN BACKGROUND OF THE INVENTION

En la actualidad, para la extracción sanguínea se suele utilizar un conjunto de elementos formado por un extractor (100) de aletas, un adaptador (200), y un tubo (300) de vacío. a) El extractor (100) de aletas es un producto específicamente diseñado para la extracción de sangre. Se trata de un dispositivo formado por una aguja (101) cuya base está dotada de un par de aletas planas (102) y de la que sale un conducto flexible (103) para el paso de la sangre en cuyo extremo proximal se encuentra una aguja (104). La Fig. 1a muestra un ejemplo de extractor (100) de aletas. b) El adaptador (200) consiste fundamentalmente en un cuerpo hueco que tiene un extremo proximal (200a) completamente abierto y un extremo distal (200b) al menos parcialmente cerrado y dotado de un orificio tapado con una membrana rasgable para el acoplamiento de la aguja proximalAt present, a set of elements consisting of a fin extractor (100), an adapter (200), and a vacuum tube (300) are usually used for blood collection. a) The fin extractor (100) is a product specifically designed for blood collection. It is a device formed by a needle (101) whose base is provided with a pair of flat fins (102) and from which a flexible conduit (103) for the passage of blood at whose proximal end is a needle (104). Fig. 1a shows an example of fin extractor (100). b) The adapter (200) consists essentially of a hollow body that has a fully open proximal end (200a) and a distal end (200b) at least partially closed and provided with a plugged hole with a tear-off membrane for needle engagement proximal

(104) del conducto flexible (103) del extractor (100) de aletas. La Fig. 1 b muestra un ejemplo de adaptador (200). c) El tubo (300) de vacío es un tubo con un tapón de plástico blando que permite que lo atraviese una aguja mediante una leve presión. El más conocido es el denominado "vacutainer, una marca comercial de Becton, Dickinson and Company. La Fig. 1 c muestra un ejemplo de tubo (300) de vacío de tipo vacutainer. Las Figs. 2a-2d muestran esquemáticamente cómo se interconectan estos elementos durante una extracción convencional. Tras insertar la aguja (101) del extractor (100) de aletas en un vaso sanguíneo del paciente, el usuario conecta el tubo flexible (103) al adaptador (200). En este ejemplo, la aguja proximal (104) del tubo flexible (103) se inserta a través del orificio distal del adaptador (200), como se muestra en la Fig. 2a. Como resultado de esta operación, la aguja proximal (104) sobresale en el interior de la cavidad del cuerpo hueco del adaptador (200), como se aprecia en la Fig. 2b. A continuación, se introduce el tubo (300) de vacío a través del lado proximal (200a) abierto del adaptador (200), como se ve en la Fig. 2c, hasta que la aguja proximal (104) atraviesa el tapón del tubo (300) de vacío. El vacío interior del tubo (300) provoca la extracción de la sangre del vaso del paciente. La Fig. 3 muestra este conjunto de elementos ya acoplados entre sí durante un proceso de extracción. (104) of the flexible conduit (103) of the fin extractor (100). Fig. 1b shows an example of adapter (200). c) The vacuum tube (300) is a tube with a soft plastic cap that allows a needle to pass through it by light pressure. The more known is the so-called "vacutainer, a trademark of Becton, Dickinson and Company. Fig. 1 c shows an example of a vacuum tube (300) of the vacutainer type. Figs. 2a-2d schematically show how these elements interconnect during a conventional extraction After inserting the needle (101) of the fin extractor (100) into a patient's blood vessel, the user connects the flexible tube (103) to the adapter (200) In this example, the proximal needle (104) of the flexible tube (103) is inserted through the distal hole of the adapter (200), as shown in Fig. 2. As a result of this operation, the proximal needle (104) protrudes inside the hollow body cavity of the adapter (200), as seen in Fig. 2b. Next, the vacuum tube (300) is introduced through the open proximal side (200a) of the adapter (200), as seen in Fig. 2c , until the proximal needle (104) passes through the cap of the vacuum tube (300). Inside the tube (300) causes blood to be drawn from the patient's vessel. Fig. 3 shows this set of elements already coupled together during an extraction process.

Este sistema es, en general, es práctico y seguro debido no requiere la manipulación de agujas. Sin embargo, cuando el calibre del vaso sanguíneo o la presión no es suficiente para que la sangre fluya hacia el tubo (300) de vacío, el usuario se ve obligado a desconectar el tubo (300) de vacío del adaptador (200) y a sustituirlo por una jeringa (400) que permita la extracción mediante presión manual tirando del émbolo. Una vez recogida la muestra en la jeringa (400), el usuario desconecta dicha jeringa (400) del adaptador (200), le conecta una aguja adicional, y termina de llenar el tubo (300) de vacío introduciendo dicha aguja adicional de la jeringa (400) a través del tapón del tubo (300) de vacío y presionando el émbolo de dicha jeringa (400). Todo este proceso implica la manipulación de agujas, por lo que pueden producirse errores y pinchazos por parte del usuario. This system is, in general, practical and safe because it does not require needle handling. However, when the blood vessel gauge or pressure is not sufficient for blood to flow into the vacuum tube (300), the user is forced to disconnect the vacuum tube (300) from the adapter (200) and replace it by a syringe (400) that allows the extraction by manual pressure by pulling the plunger. Once the sample has been collected in the syringe (400), the user disconnects said syringe (400) from the adapter (200), connects an additional needle, and finishes filling the vacuum tube (300) by introducing said additional needle from the syringe (400) through the cap of the vacuum tube (300) and pressing the plunger of said syringe (400). This whole process involves the manipulation of needles, so that errors and punctures can occur on the part of the user.

DESCRIPCIÓN DE LA INVENCIÓN DESCRIPTION OF THE INVENTION

La presente invención describe un novedoso dispositivo que permite realizar cómodamente una extracción convencional con tubo de vacío, así como llevar a cabo las operaciones necesarias para la extracción manual con aguja en caso de necesidad, todo ello sin necesidad de manipular agujas. El dispositivo de seguridad de la invención comprende fundamentalmente un cuerpo hueco y una aguja móvil alojada en su interior. A continuación, se describe cada uno de estos elementos con mayor detalle. a) Cuerpo hueco The present invention describes a novel device that allows a conventional extraction with a vacuum tube to be conveniently carried out, as well as carrying out the necessary operations for manual needle extraction if necessary, all without the need to manipulate needles. The security device of the invention basically comprises a hollow body and a moving needle housed inside. Each of these elements is described in more detail below. a) Hollow body

Se trata de un cuerpo hueco que tiene un conector para jeringa en su lado proximal y un orificio en su lado distal, estando este orificio tapado por una membrana rasgable. Normalmente el cuerpo tiene una forma esencialmente cilindrica que puede tener un estrechamiento en su porción distal donde se encuentra el orificio. Preferentemente, el cuerpo es transparente para permitir al usuario observar claramente la posición de la aguja móvil. El conector puede configurarse de diferentes modos siempre que permita la conexión de la punta de una jeringa del tipo convencionalmente empleado para la extracción de sangre. Por ejemplo, puede tratarse de un conector hembra configurado para la recepción de la punta de la jeringa o bien de un conector macho diseñado para introducirse a través del orificio de dicha punta. De acuerdo con una realización preferida, el conector comprende un orificio cónico destinado a la recepción del conector luer macho que constituye la punta de una jeringa convencional. It is a hollow body that has a syringe connector on its proximal side and a hole on its distal side, this hole being covered by a tear-off membrane. Normally the body has an essentially cylindrical shape that can have a narrowing in its distal portion where the hole is located. Preferably, the body is transparent to allow the user to clearly observe the position of the moving needle. The connector can be configured in different ways as long as it allows the connection of the tip of a syringe of the type conventionally used for blood collection. For example, it may be a female connector configured for the reception of the syringe tip or a male connector designed to be inserted through the orifice of said tip. According to a preferred embodiment, the connector comprises a conical hole intended for receiving the male luer connector that constitutes the tip of a conventional syringe.

El orificio del lado distal del cuerpo hueco debe tener un tamaño suficiente como para permitir el paso de la aguja móvil. La membrana rasgable está configurada para mantener esencialmente la estanqueidad cuando es atravesada por una aguja por los motivos que se describen más adelante. Para ello, puede estar hecha de cualquier material que cumpla está función, como por ejemplo papel, goma o caucho. b) Aguja móvil The hole in the distal side of the hollow body must be of sufficient size to allow the passage of the moving needle. The tear-off membrane is configured to essentially maintain the tightness when it is pierced by a needle for the reasons described below. For this, it can be made of any material that fulfills this function, such as paper, rubber or rubber. b) Mobile needle

Se trata de una aguja móvil que tiene una base conectada al conector y una punta, donde la aguja es desplazable desde una posición replegada en la que la punta está en el interior del cuerpo hueco hasta una posición extendida en que la punta sobresale a través del orificio del cuerpo hueco. El dispositivo se suministra con la aguja en su posición replegada para evitar cualquier posibilidad de pinchazo por parte del usuario. La base de la aguja está conectada al conector de tal modo que permite que la sangre extraída al paciente pase a través de la aguja en dirección a su base y de ahí pase a través el conector hasta el interior de una jeringa conectada al mismo, o bien en sentido contrario desde dicha jeringa a través del conector primero y de la aguja después en dirección a un tubo de vacío fijado a la punta de dicha aguja, como se describirá con detalle más adelante en este documento. It is a moving needle that has a base connected to the connector and a tip, where the needle is movable from a retracted position where the tip is inside the hollow body to an extended position in that the tip protrudes through the hole in the hollow body. The device is supplied with the needle in its retracted position to avoid any possibility of puncture by the user. The needle base is connected to the connector in such a way that it allows blood drawn to the patient to pass through the needle in the direction of its base and from there it passes through the connector to the inside of a syringe connected to it, or either in the opposite direction from said syringe through the connector first and then the needle in the direction of a vacuum tube attached to the tip of said needle, as will be described in detail later in this document.

La aguja puede configurarse de diferentes modos siempre que permita su desplazamiento desde la posición replegada hasta la posición extendida. Más adelante se describen algunas realizaciones preferidas. The needle can be configured in different ways as long as it allows its movement from the stowed position to the extended position. Some preferred embodiments are described below.

Para llevar a cabo un procedimiento de extracción normal, primero se introduce normalmente la aguja de un extractor de aletas convencional en el vaso sanguíneo del paciente. A continuación, la aguja proximal del conducto flexible de dicho extractor de aletas se introduce a través del orificio distal de un adaptador convencional y se acopla un tubo de vacío a dicho adaptador de modo que dicha aguja proximal atraviesa el tapón del tubo de vacío. En esta situación, la sangre del paciente es succionada a través del tubo flexible del extractor de aletas como consecuencia del vacío hasta depositarse en el tubo. Hasta aquí, se trata de un procedimiento de extracción convencional. To carry out a normal extraction procedure, the needle of a conventional fin extractor is normally inserted into the patient's blood vessel. Next, the proximal needle of the flexible conduit of said fin extractor is inserted through the distal orifice of a conventional adapter and a vacuum tube is attached to said adapter so that said proximal needle passes through the vacuum tube cap. In this situation, the patient's blood is sucked through the flexible tube of the fin extractor as a result of the vacuum until it is deposited in the tube. So far, it is a conventional extraction procedure.

Como se ha comentado con anterioridad, si la presión del tubo de vacío no es suficiente para succionar la sangre del paciente se requiere el uso de una jeringa manual. Para ello, el usuario desconecta el tubo de vacío del adaptador. A continuación, se introduce el dispositivo de la invención en el adaptador hasta que la aguja proximal del conducto flexible del extractor de aletas, que como se mencionó anteriormente pasa a través del orificio distal del adaptador y se extiende a lo largo de su interior, atraviesa la membrana rasgable del orificio ubicado en el lado distal del dispositivo de la invención. Se conecta entonces una jeringa al conector del lado proximal del dispositivo de la invención. En esta situación, existe una conexión fluida cerrada entre la jeringa y el vaso sanguíneo del usuario, ya que la membrana rasgable mantiene la estanqueidad de la conexión con la aguja proximal del conducto flexible del extractor de aletas. El usuario tira del émbolo de la jeringa y la llena con la sangre del paciente. As previously mentioned, if the pressure of the vacuum tube is not sufficient to suck the patient's blood, the use of a manual syringe is required. To do this, the user disconnects the vacuum tube from the adapter. Next, the device of the invention is introduced into the adapter until the proximal needle of the flexible duct extractor duct, which as mentioned above passes through the distal hole of the adapter and extends along its interior, passes through the tear hole membrane located on the distal side of the device of the invention. A syringe is then connected to the connector on the proximal side of the device of the invention. In this situation, there is a fluid connection closed between the syringe and the user's blood vessel, as the tear-off membrane maintains the tightness of the connection with the proximal needle of the flexible duct extractor duct. The user pulls the syringe plunger and fills it with the patient's blood.

Para introducir posteriormente la sangre almacenada en la jeringa en el tubo de vacío, el usuario desconecta el dispositivo de la invención de la aguja proximal del conducto flexible del extractor de aletas y lo saca del adaptador. Seguidamente, hace pasar la aguja móvil del dispositivo desde su posición replegada hasta su posición extendida. Como se verá a continuación, esto se puede hacer de diferentes modos. Una vez en la posición extendida, la aguja móvil sobresale exteriormente a través del orificio ubicado en el lado distal del cuerpo hueco. El usuario conecta entonces el dispositivo de la invención al tubo de vacío haciendo que la punta de dicha aguja móvil atraviese el tapón de dicho tubo de vacío. En esta situación, existe una conexión fluida cerrada entre la jeringa y el tubo de vacío. El usuario empuja el émbolo de la jeringa para introducir la sangre almacenada en la misma en el tubo de vacío. To subsequently introduce the blood stored in the syringe into the vacuum tube, the user disconnects the device of the invention from the proximal needle of the flexible duct of the fin extractor and takes it out of the adapter. Next, it passes the mobile needle of the device from its retracted position to its extended position. As will be seen below, this can be done in different ways. Once in the extended position, the moving needle protrudes externally through the hole located on the distal side of the hollow body. The user then connects the device of the invention to the vacuum tube by causing the tip of said movable needle to pass through the cap of said vacuum tube. In this situation, there is a closed fluid connection between the syringe and the vacuum tube. The user pushes the syringe plunger to introduce the blood stored therein into the vacuum tube.

De acuerdo con una realización preferida, el dispositivo de la invención comprende además unos medios de anclaje configurados para mantener la aguja móvil en su estado replegado y unos medios de extensión configurados para impulsar la aguja móvil desde la posición replegada a la posición extendida cuando se liberan los medios de anclaje. According to a preferred embodiment, the device of the invention further comprises anchoring means configured to keep the moving needle in its retracted state and extension means configured to drive the moving needle from the retracted position to the extended position when they are released. the anchoring means.

Los medios de anclaje se pueden implementar de diferentes modos. Por ejemplo, pueden estar formados por una palanca que se engancha en una muesca o cavidad de la aguja para impedir su desplazamiento a la posición extendida. También pueden estar constituidos por una zona de sellado entre la aguja y el cuerpo hueco, de modo que una presión externa por parte de un usuario provoque la rotura del sello y la liberación de la aguja. O bien puede emplearse un par de rebordes respectivamente ubicados en la aguja y en el cuerpo hueco que cooperan entre sí para impedir el desplazamiento de la aguja excepto cuando se realiza una determinada rotación de la aguja. Existen multitud de mecanismos diseñados para este fin, pudiendo mencionarse a modo de ejemplo los empleados en bolígrafos y dispositivos para la aplicación de insulina. Más adelante se describe de manera más detallada un ejemplo de medio de anclaje. En cuanto a los medios de extensión, preferentemente comprenden un resorte conectado a la aguja móvil que está pre-comprimido cuando dicha aguja está en la posición replegada. De ese modo, cuando se liberan los medios de anclaje y la aguja queda liberada, el resorte la impulsa de manera automática hacia la posición extendida. The anchoring means can be implemented in different ways. For example, they can be formed by a lever that engages in a notch or needle cavity to prevent its displacement to the extended position. They can also consist of a sealing zone between the needle and the hollow body, so that an external pressure by a user causes the seal to break and the needle to be released. Or, a pair of flanges can be used respectively located on the needle and in the hollow body that cooperate with each other to prevent displacement of the needle except when a certain rotation of the needle is performed. There are a multitude of mechanisms designed for this purpose, mentioning by way of example those used in pens and devices for the application of insulin. An example of anchoring means is described in more detail below. As for the extension means, they preferably comprise a spring connected to the mobile needle that is pre-compressed when said needle is in the retracted position. Thus, when the anchoring means are released and the needle is released, the spring automatically drives it towards the extended position.

En una realización particularmente preferida de la invención, la aguja móvil es telescópica. Es decir, la aguja está formada por varias secciones cilindricas de diámetros ligeramente diferentes que están conectadas entre sí de manera que, en la posición replegada, cada sección se encuentra alojada en la sección adyacente de diámetro superior, mientras que en la posición extendida las secciones únicamente se superponen en una zona de los respectivos extremos que las mantienen unidas una a la otra. En este caso concreto, el resorte puede estar fijado entre la punta de la aguja móvil y el conector, de tal manera que provoca la extensión automática completa de la aguja cuando se liberan los medios de anclaje. In a particularly preferred embodiment of the invention, the mobile needle is telescopic. That is, the needle is formed by several cylindrical sections of slightly different diameters that are connected to each other so that, in the retracted position, each section is housed in the adjacent upper diameter section, while in the extended position the sections they only overlap in an area of the respective ends that hold them together. In this specific case, the spring may be fixed between the tip of the movable needle and the connector, such that it causes the complete automatic extension of the needle when the anchoring means are released.

En otra realización particularmente preferida de la invención, la aguja móvil y el conector constituyen una única pieza que está acoplada de manera deslizante al cuerpo hueco. De ese modo, el paso de la aguja desde la posición replegada a la posición extendida implica el deslizamiento de dicha pieza formada por aguja y conector desde una posición inicial retrasada donde la aguja está completamente dentro del cuerpo hueco hasta una posición final más adelantada donde la aguja sobresale a través del orificio distal del cuerpo hueco. Este deslizamiento se produce impulsado por el resorte, que en este caso puede estar fijado entre la aguja móvil y el lado proximal del cuerpo hueco. In another particularly preferred embodiment of the invention, the movable needle and the connector constitute a single piece that is slidably coupled to the hollow body. Thus, the passage of the needle from the retracted position to the extended position implies the sliding of said piece formed by needle and connector from a delayed initial position where the needle is completely inside the hollow body to a more advanced final position where the needle protrudes through the distal hole of the hollow body. This sliding is produced by the spring, which in this case can be fixed between the moving needle and the proximal side of the hollow body.

En esta realización particular donde la aguja desliza desde la posición replegada a la posición extendida, los medios de anclaje preferentemente comprenden al menos un primer reborde ubicado en el lado proximal del cuerpo hueco y un segundo reborde ubicado en la base de la aguja móvil. Estos dos rebordes cooperan entre sí de modo que, en la posición replegada, impiden el desplazamiento longitudinal de la pieza formada por la aguja móvil y el conector hacia la posición extendida. Sin embargo, un giro relativo de dicha pieza formada por la aguja móvil y el conector con relación al cuerpo hueco libera dicha pieza permitiendo su paso desde la posición replegada a la posición extendida, lo que ocurre de manera automática debido a la acción del resorte. Los rebordes pueden ocupar sólo una parte de la circunferencia de la aguja y el cuerpo hueco, de manera que un giro de, por ejemplo, un cuarto de vuelta, libere el acoplamiento entre ellos y permita el deslizamiento de aguja y conector en dirección distal por la fuerza del resorte. In this particular embodiment where the needle slides from the retracted position to the extended position, the anchoring means preferably comprise at least a first flange located on the proximal side of the hollow body and a second flange located at the base of the movable needle. These two flanges cooperate with each other so that, in the retracted position, they prevent the longitudinal displacement of the part formed by the movable needle and the connector towards the extended position. However, a relative rotation of said piece formed by the movable needle and the connector relative to the hollow body releases said piece allowing its passage from the retracted position to the extended position, which happens automatically due to the spring action. The flanges can occupy only a part of the circumference of the needle and the hollow body, so that a turn of, for example, a quarter turn, releases the coupling between them and allows the sliding of the needle and connector distally by the force of the spring

BREVE DESCRIPCIÓN DE LAS FIGURAS BRIEF DESCRIPTION OF THE FIGURES

Las Figs. 1 a-1 c muestran los diferentes elementos empleados en un procedimiento de extracción sanguínea convencional según la técnica anterior. Figs. 1 a-1 c show the different elements used in a conventional blood collection procedure according to the prior art.

Las Figs. 2a-2d ilustran el modo en que se conectan los mencionados elementos de la técnica anterior para realizar una extracción sanguínea convencional. La Fig. 3 muestra los mencionados elementos de la técnica anterior ya conectados durante una extracción sanguínea convencional. Figs. 2a-2d illustrate the way in which the aforementioned elements of the prior art are connected to perform a conventional blood collection. Fig. 3 shows the aforementioned elements of the prior art already connected during a conventional blood collection.

Las Figs. 4a y 4b muestran sendas vistas en perspectiva de una primera configuración del dispositivo de la presente invención respectivamente con una aguja telescópica en su posición replegada y en su posición extendida. Figs. 4a and 4b show perspective views of a first configuration of the device of the present invention respectively with a telescopic needle in its retracted position and in its extended position.

Las Figs. 5a y 5b muestran sendas secciones longitudinales de la primera configuración del dispositivo de la invención respectivamente con la aguja telescópica en su posición replegada y en su posición extendida. Figs. 5a and 5b show longitudinal sections of the first configuration of the device of the invention respectively with the telescopic needle in its retracted position and in its extended position.

Las Figs. 6a y 6b muestran sendas vistas en perspectiva de una segunda configuración del dispositivo de la presente invención respectivamente con una aguja móvil en su posición replegada y en su posición extendida. Las Figs. 7a y 7b muestran sendas secciones longitudinales de la segunda configuración del dispositivo de la invención respectivamente con la aguja móvil en su posición replegada y en su posición extendida. Figs. 6a and 6b show perspective views of a second configuration of the device of the present invention respectively with a movable needle in its retracted position and in its extended position. Figs. 7a and 7b show longitudinal sections of the second configuration of the device of the invention respectively with the movable needle in its retracted position and in its extended position.

La Fig. 8 muestra el dispositivo de la invención según la segunda configuración conectado entre una jeringa convencional y un extractor de aletas para la extracción de sangre cuando no basta con la presión de un tubo de vacío. Fig. 8 shows the device of the invention according to the second configuration connected between a conventional syringe and a fin extractor for extraction of blood when the pressure of a vacuum tube is not enough.

La Fig. 9 muestra el dispositivo de la invención según la segunda configuración conectado entre la jeringa convencional y un tubo de vacío para pasar la sangre extraída anteriormente de la jeringa convencional al tubo de vacío. Fig. 9 shows the device of the invention according to the second configuration connected between the conventional syringe and a vacuum tube to pass the blood previously drawn from the conventional syringe to the vacuum tube.

REALIZACIONES PREFERENTES DE LA INVENCIÓN PREFERRED EMBODIMENTS OF THE INVENTION

Las Figs. 1-3 muestran los elementos convencionalmente empleados en la técnica anterior que ya se han descrito en este documento en el apartado de antecedentes. Figs. 1-3 show the elements conventionally used in the prior art that have already been described in this document in the background section.

Las Figs. 4-5 muestran un ejemplo de dispositivo (1) de acuerdo con una primera configuración de la presente invención donde la aguja (5) es telescópica. El dispositivo (1) comprende un cuerpo (2) hueco transparente que aloja la aguja (5) telescópica. El cuerpo (2) hueco tiene una forma esencialmente cilindrica con un lado proximal dotado de un conector (3) y un lado distal dotado de un orificio (4). En este ejemplo concreto, el lado distal del cuerpo (2) hueco se estrecha en las proximidades del orificio (4). El orificio (4) está tapado mediante una membrana rasgable hecha de caucho. La aguja (5) extensible está formada por cuatro secciones telescópicas que encajan unas dentro de otras. La aguja (5) telescópica se presenta inicialmente en una posición replegada en la que la punta (5b) está íntegramente alojada en el interior del cuerpo (2) hueco, como se aprecia en las Figs. 4a y 5a. La aguja (5) telescópica puede adoptar una posición extendida en la que sale a través del orificio (4) del lado distal del dispositivo (1), como muestran las Figs. 4b y 5b. Figs. 4-5 show an example of device (1) according to a first configuration of the present invention where the needle (5) is telescopic. The device (1) comprises a transparent hollow body (2) that houses the telescopic needle (5). The hollow body (2) has an essentially cylindrical shape with a proximal side provided with a connector (3) and a distal side provided with a hole (4). In this specific example, the distal side of the hollow body (2) narrows in the vicinity of the hole (4). The hole (4) is covered by a tear-off membrane made of rubber. The extensible needle (5) is formed by four telescopic sections that fit into each other. The telescopic needle (5) is initially presented in a retracted position in which the tip (5b) is fully housed inside the hollow body (2), as seen in Figs. 4th and 5th. The telescopic needle (5) can adopt an extended position in which it exits through the hole (4) on the distal side of the device (1), as shown in Figs. 4b and 5b.

Para hacer pasar la aguja (5) desde la posición replegada a la posición extendida, se dispone un resorte (6) fijado al lado proximal del cuerpo (2) hueco y al extremo distal (5b) de la aguja (5). Este resorte (6) se encuentra en posición pre-comprimida cuando la aguja (5) está en posición replegada. Unos medios de anclaje (no mostrados en las figuras) mantienen bloqueada la aguja en esta posición replegada. Cuando el usuario actúa sobre dichos medios de anclaje, por ejemplo pulsando un botón o accionando una palanca, libera la aguja (5) y automáticamente la fuerza del resorte (6) la impulsa hacia su posición extendida. La base (5a) de la aguja (5) telescópica está fijada a la cara interior del lado proximal del cuerpo (2) hueco de tal manera que está en conexión fluida con el conector (3) fijado a la cara exterior de dicho lado proximal del cuerpo (2) hueco. El conector (3) consiste fundamentalmente en una pieza cilindrica dotada de un orificio longitudinal troncocónico especialmente dimensionado para el acoplamiento mediante presión del conector luer macho de una jeringa (400) convencional. In order to pass the needle (5) from the retracted position to the extended position, a spring (6) fixed to the proximal side of the hollow body (2) and to the distal end (5b) of the needle (5) is arranged. This spring (6) is in a pre-compressed position when the needle (5) is in the retracted position. Anchoring means (not shown in the figures) keep the needle locked in this retracted position. When the user acts on said anchoring means, for example by pressing a button or by operating a lever, he releases the needle (5) and automatically the force of the spring (6) drives it towards its extended position. The base (5a) of the telescopic needle (5) is fixed to the inner face of the proximal side of the hollow body (2) in such a way that it is in fluid connection with the connector (3) fixed to the outer face of said proximal side of the body (2) hollow. The connector (3) consists essentially of a cylindrical part equipped with a longitudinal frustoconical hole specially sized for coupling by pressing the male luer connector of a conventional syringe (400).

Las Figs. 6-7 muestran una segunda configuración del dispositivo (1) de la invención similar a la primera configuración excepto por que la aguja (5) móvil en este caso no es telescópica. Por ello, se omite aquí una descripción de los elementos similares y se describe con detalle la aguja (5) y los medios de extensión y anclaje. Figs. 6-7 show a second configuration of the device (1) of the invention similar to the first configuration except that the mobile needle (5) in this case is not telescopic. Therefore, a description of the similar elements is omitted here and the needle (5) and the extension and anchoring means are described in detail.

La aguja (5) de esta segunda configuración está unida al conector (3) formando una única pieza que se desplaza solidariamente, y esta pieza está acoplada de manera longitudinalmente deslizante al cuerpo (2) hueco. Así, en esta segunda configuración, para pasar de la posición replegada a la posición extendida se desplaza toda la pieza formada por conector (3) y aguja (5), como se puede apreciar en las Figs. 6 y 7. Para ello, al igual que en la primera configuración, se emplea un resorte (6) que tiene un primer extremo fijado a la base del cuerpo (2) hueco y un segundo extremo fijado a la aguja (5) móvil. En el estado replegado, el resorte (6) está pre-comprimido, y unos medios de anclaje evitan el paso al estado extendido. Cuando se liberan los medios de anclaje, el resorte (6) impulsa la pieza formada por conector (3) y aguja (5), que de ese modo se desplaza longitudinalmente en sentido distal hasta la posición extendida en que la punta (5b) de la aguja (5) sobresale a través del orificio (4) del cuerpo (2) hueco. The needle (5) of this second configuration is attached to the connector (3) forming a single piece that moves in solidarity, and this piece is longitudinally slidably coupled to the hollow body (2). Thus, in this second configuration, to move from the retracted position to the extended position, the entire piece formed by connector (3) and needle (5) is moved, as can be seen in Figs. 6 and 7. For this, as in the first configuration, a spring (6) is used having a first end fixed to the base of the hollow body (2) and a second end fixed to the moving needle (5). In the retracted state, the spring (6) is pre-compressed, and anchoring means prevent the passage to the extended state. When the anchoring means are released, the spring (6) drives the piece formed by connector (3) and needle (5), which thereby travels longitudinally distally to the extended position where the tip (5b) of the needle (5) protrudes through the hole (4) of the hollow body (2).

No se representan los medios de anclaje en esta figura, aunque como se ha comentado anteriormente pueden utilizarse en esta segunda configuración un primer reborde ubicado en el lado proximal del cuerpo (2) hueco y un segundo reborde ubicado en la base (5a) de la aguja (5) móvil. Estos rebordes pueden ocupar, por ejemplo, 90° de la circunferencia de ambos elementos. De ese modo, cuando la pieza formada por conector (3) y aguja (5) está en la posición replegada, el segundo reborde ubicado en la aguja (5) choca con el primer reborde ubicado en el cuerpo (2) hueco, impidiendo que el resorte (6) haga pasar la aguja a la posición extendida. Cuando el usuario realiza un giro de la pieza formada por conector (3) y aguja (5) hasta desacoplar los rebordes, la pieza queda libre para deslizar longitudinalmente y como consecuencia el resorte (6) automáticamente la hace pasar a la posición extendida. The anchoring means are not shown in this figure, although as mentioned above, a first flange located on the proximal side of the hollow body (2) and a second flange located at the base (5a) of the second configuration can be used in this second configuration. needle (5) mobile. These flanges can occupy, for example, 90 ° of the circumference of both elements. Thus, when the piece formed by connector (3) and needle (5) is in the retracted position, the second flange located in the needle (5) collides with the first flange located in the hollow body (2), preventing the spring (6) pass the needle to the extended position. When the user makes a rotation of the piece formed by connector (3) and needle (5) until uncouple the flanges, the piece is free to slide longitudinally and as a consequence the spring (6) automatically moves it to the extended position.

Las Figs. 8 y 9 muestran un ejemplo de uso del dispositivo (1) de la invención según la segunda configuración mostrada en las Figs. 6-7. Se comienza un procedimiento de extracción convencional como el descrito en los antecedentes de este documento. El montaje empleado se muestra en la Fig. 3. En esa situación, en caso de que la sangre no fluya hacia el interior del tubo (300) por cualquier motivo, se procede a utilizar el dispositivo (1) de la invención. En este primer paso del procedimiento, la aguja (5) móvil del dispositivo (1) se encuentra en su posición replegada. Primero, se desacopla el tubo (300) de la aguja (104) proximal del extractor (100) de aletas. A continuación, se introduce el dispositivo (1) en el adaptador (200) de tal modo que la aguja (104) se introduce a través del orificio (4), rasgando la membrana. Por otra parte, se acopla el extremo macho luer de una jeringa (400) convencional al conector (3) del dispositivo (1). La membrana rasgable, de caucho en este ejemplo, mantiene la estanqueidad, de modo que la depresión creada por la retracción del émbolo de la jeringa (400) provoca que la sangre del paciente fluya a través del tubo (103) flexible, pase a través de la aguja (104) proximal y de la aguja (5) móvil, y finalmente pase por el conector (3) hasta llegar al interior de la jeringa (400). El inicio de esta operación se muestra en la Fig. 6. Figs. 8 and 9 show an example of use of the device (1) of the invention according to the second configuration shown in Figs. 6-7. A conventional extraction procedure is started as described in the background of this document. The assembly used is shown in Fig. 3. In this situation, if the blood does not flow into the tube (300) for any reason, the device (1) of the invention is used. In this first step of the procedure, the mobile needle (5) of the device (1) is in its retracted position. First, the tube (300) of the needle (104) proximal to the fin extractor (100) is disengaged. Next, the device (1) is introduced into the adapter (200) such that the needle (104) is inserted through the hole (4), tearing the membrane. On the other hand, the male luer end of a conventional syringe (400) is coupled to the connector (3) of the device (1). The rubber tear-off membrane in this example maintains tightness, so that the depression created by the retraction of the syringe plunger (400) causes the patient's blood to flow through the flexible tube (103), pass through of the proximal needle (104) and the mobile needle (5), and finally pass through the connector (3) until it reaches the inside of the syringe (400). The start of this operation is shown in Fig. 6.

Una vez la jeringa (400) está llena con la sangre del paciente, se extraen la jeringa (400) y el dispositivo (1) del adaptador (200), de tal manera que la aguja (104) proximal sale a través del orificio (4). A continuación, se liberan los medios de anclaje del dispositivo (1) para hacer que la aguja (5) móvil pase desde su posición replegada a su posición extendida. En este ejemplo, se realiza un giro de la pieza formada por el conector (3) y la aguja (5) móvil de 90° con relación al cuerpo (2) hueco que libera el acoplamiento entre los rebordes correspondientes. El desplazamiento hacia la posición extendida se produce entonces de manera automática gracias al resorte (6). Una vez hecho esto, la punta (5b) de la aguja (5), que sobresale a través del orificio (4) del cuerpo (2) hueco, se inserta a través del tapón del tubo (300) de vacío que se había comenzado a utilizar al principio del procedimiento convencional de extracción, y se presiona el émbolo de la jeringa (400) para hacer que la sangre almacenada en dicha jeringa (400) pase finalmente al interior de dicho tubo (300). Once the syringe (400) is filled with the patient's blood, the syringe (400) and the device (1) of the adapter (200) are removed, such that the proximal needle (104) exits through the hole ( 4). Next, the anchoring means of the device (1) are released to make the moving needle (5) pass from its retracted position to its extended position. In this example, a rotation of the part formed by the connector (3) and the moving needle (5) of 90 ° in relation to the hollow body (2) that releases the coupling between the corresponding flanges is performed. The displacement towards the extended position then occurs automatically thanks to the spring (6). Once this is done, the tip (5b) of the needle (5), which protrudes through the hole (4) of the hollow body (2), is inserted through the cap of the vacuum tube (300) that had begun to be used at the beginning of the conventional extraction procedure, and the syringe plunger (400) is pressed to make the blood stored in said syringe (400) finally pass into said tube (300).

Claims

REIVINDICACIONES 1. Dispositivo (1) de seguridad para la realización de extracciones sanguíneas, caracterizado por que comprende: 1. Safety device (1) for performing blood extractions, characterized in that it comprises: - un cuerpo (2) hueco que tiene un conector (3) para jeringa en su lado proximal y un orificio (4) en su lado distal, estando el orificio (4) tapado por una membrana rasgable; y  - a hollow body (2) having a syringe connector (3) on its proximal side and a hole (4) on its distal side, the hole (4) being covered by a tear-off membrane; Y - una aguja (5) móvil que tiene una base (5a) unida al conector (3) y una punta - a mobile needle (5) having a base (5a) attached to the connector (3) and a tip (5b), (5b), donde la aguja (5) móvil es desplazable desde una posición replegada en la que la punta (5b) está en el interior del cuerpo (2) hueco hasta una posición extendida en que la punta (5a) sobresale a través del orificio (4) del cuerpo hueco.  where the mobile needle (5) is movable from a retracted position in which the tip (5b) is inside the hollow body (2) to an extended position in which the tip (5a) protrudes through the hole (4) of the hollow body. 2. Dispositivo (1) de acuerdo con la reivindicación 1 , que además comprende: 2. Device (1) according to claim 1, further comprising: - unos medios de anclaje configurados para mantener la aguja (5) móvil en su estado replegado; y  - anchoring means configured to keep the moving needle (5) in its retracted state; Y - unos medios de extensión configurados para impulsar la aguja (5) móvil desde la posición replegada a la posición extendida cuando se liberan los medios de anclaje.  - extension means configured to drive the moving needle (5) from the retracted position to the extended position when the anchoring means are released. 3. Dispositivo (1) de acuerdo con la reivindicación 2, donde los medios de extensión comprenden un resorte (6) conectado a la aguja (5) móvil que está pre-comprimido cuando dicha aguja (5) está en la posición replegada. 3. Device (1) according to claim 2, wherein the extension means comprise a spring (6) connected to the mobile needle (5) that is pre-compressed when said needle (5) is in the retracted position. 4. Dispositivo (1) de acuerdo con la reivindicación 3, donde la aguja (5) móvil es telescópica. 4. Device (1) according to claim 3, wherein the mobile needle (5) is telescopic. 5. Dispositivo (1) de acuerdo con la reivindicación 4, donde el resorte (6) está fijado entre la punta (5b) de la aguja (5) móvil y el conector (3). 5. Device (1) according to claim 4, wherein the spring (6) is fixed between the tip (5b) of the movable needle (5) and the connector (3). 6. Dispositivo (1) de acuerdo con la reivindicación 3, donde la aguja (5) móvil y el conector (3) constituyen una única pieza que está acoplada de manera deslizante al cuerpo (2) hueco. Device (1) according to claim 3, wherein the mobile needle (5) and the connector (3) constitute a single piece that is slidably coupled to the hollow body (2). 7. Dispositivo (1) de acuerdo con la reivindicación 6, donde el resorte (6) está fijado entre la aguja (5) móvil y el lado proximal del cuerpo (2) hueco. 7. Device (1) according to claim 6, wherein the spring (6) is fixed between the moving needle (5) and the proximal side of the hollow body (2). 8. Dispositivo de acuerdo con cualquiera de las reivindicaciones 6-7, donde los medios de anclaje comprenden al menos un primer reborde ubicado en el lado proximal del cuerpo (2) hueco y un segundo reborde ubicado en la base de la aguja (5) móvil que cooperan entre sí de modo que en la posición replegada impiden el desplazamiento longitudinal de la pieza formada por la aguja (5) móvil y el conector (3) hacia la posición extendida, y donde un giro relativo de dicha pieza formada por la aguja (5) móvil y el conector (3) con relación al cuerpo (2) hueco libera dicha pieza permitiendo su paso desde la posición replegada a la posición extendida de manera automática por la acción del resorte (6). 8. Device according to any of claims 6-7, wherein the anchoring means comprise at least a first flange located on the proximal side of the hollow body (2) and a second flange located at the base of the needle (5) mobile that cooperate with each other so that in the retracted position they prevent the longitudinal displacement of the piece formed by the mobile needle (5) and the connector (3) towards the extended position, and where a relative rotation of said piece formed by the needle (5) mobile and the connector (3) in relation to the hollow body (2) releases said piece allowing its passage from the retracted position to the position automatically extended by the action of the spring (6). 9. Dispositivo (1) de acuerdo con cualquiera de las reivindicaciones anteriores, donde la membrana rasgable está hecha de uno de los materiales de la siguiente lista: papel, goma y caucho. 9. Device (1) according to any of the preceding claims, wherein the tear-off membrane is made of one of the materials in the following list: paper, rubber and rubber. 10. Dispositivo (1) de acuerdo con cualquiera de las reivindicaciones anteriores, donde el conector (3) comprende un orificio cónico para la recepción de un conector luer macho. 10. Device (1) according to any one of the preceding claims, wherein the connector (3) comprises a conical hole for receiving a male luer connector. 1 1. Dispositivo (1) de acuerdo con cualquiera de las reivindicaciones anteriores, donde el cuerpo (2) hueco es transparente. 1 1. Device (1) according to any of the preceding claims, wherein the hollow body (2) is transparent.
PCT/ES2016/070491 2015-07-02 2016-07-01 Safety device for blood extraction Ceased WO2017001719A1 (en)

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ESP201530953 2015-07-02
ES201530953A ES2599633B1 (en) 2015-07-02 2015-07-02 Safety device for blood draws

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3612051A (en) * 1968-07-24 1971-10-12 Raul Olvera Arce Hypodermic syringe applicating device
WO1991011212A1 (en) * 1990-02-02 1991-08-08 Gerard Philip Gilliland A retractable sharp
US5242401A (en) * 1992-10-09 1993-09-07 Colsky Andrew E Disposable needle head assembly
US5279583A (en) * 1992-08-28 1994-01-18 Shober Jr Robert C Retractable injection needle assembly
US20050267384A1 (en) * 2004-06-01 2005-12-01 Sauer Kevin P Blood collection kit adapter
CN104740717A (en) * 2015-03-27 2015-07-01 朱小菊 Retractable transformable needle

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3612051A (en) * 1968-07-24 1971-10-12 Raul Olvera Arce Hypodermic syringe applicating device
WO1991011212A1 (en) * 1990-02-02 1991-08-08 Gerard Philip Gilliland A retractable sharp
US5279583A (en) * 1992-08-28 1994-01-18 Shober Jr Robert C Retractable injection needle assembly
US5242401A (en) * 1992-10-09 1993-09-07 Colsky Andrew E Disposable needle head assembly
US20050267384A1 (en) * 2004-06-01 2005-12-01 Sauer Kevin P Blood collection kit adapter
CN104740717A (en) * 2015-03-27 2015-07-01 朱小菊 Retractable transformable needle

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ES2599633B1 (en) 2017-11-08

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