WO2017212101A1 - Device for inserting a flexible cannula - Google Patents

Device for inserting a flexible cannula Download PDF

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Publication number
WO2017212101A1
WO2017212101A1 PCT/ES2017/070414 ES2017070414W WO2017212101A1 WO 2017212101 A1 WO2017212101 A1 WO 2017212101A1 ES 2017070414 W ES2017070414 W ES 2017070414W WO 2017212101 A1 WO2017212101 A1 WO 2017212101A1
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WO
WIPO (PCT)
Prior art keywords
flexible cannula
rigid guide
patient
extension
skin
Prior art date
Application number
PCT/ES2017/070414
Other languages
Spanish (es)
French (fr)
Inventor
Ángela ORTEGA LÓPEZ
José Manuel GARCÍA PINILLA
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 WO2017212101A1 publication Critical patent/WO2017212101A1/en

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Classifications

    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • 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

Definitions

  • the present invention belongs in general to the field of medicine, and more particularly to the elements used for continuous infusion of drugs to a patient.
  • the object of the present invention is a device designed for insertion of a flexible cannula in a patient for the continuous administration of drugs.
  • Continuous infusion of drugs to a patient continuously is widely developed today.
  • devices designed to continuously drive a drug through a conduit that ends in a flexible needle or cannula that is introduced into the patient either intravenously or subcutaneously are the so-called elastomeric pumps.
  • An elastomeric pump essentially comprises an elastic drug reservoir capable of creating a continuous positive pressure sufficient to drive the drug, a capillary that restricts the outflow of the elastic reservoir, and a conduit that allows the said outflow to be transported to the patient.
  • Other known devices simply rely on gravity to achieve drug delivery.
  • the Accu-Check Tenderlink is mainly formed by a dressing that is fixed on the patient's skin equipped with a metal guide for a flexible cannula. First, a part of the dressing is pasted on the patient's skin. Next, the metal guide is used to insert the cannula into the patient's skin, then the guide is removed through the area Rear of the flexible cannula tube. Finally, the end of the conduit from the drug delivery device is connected by means of a connection element designed for this purpose.
  • Patent document EP2397180 describes the Accu-Check Tenderlink product in greater detail.
  • devices such as the Accu-Check Tenderlink have the disadvantage that the operation of extraction of the metal cannula and subsequent connection of the drug conduit can allow contamination to enter. Indeed, once the flexible cannula is inserted under the patient's skin thanks to the metal guide, it is necessary to remove said metal guide and then connect the drug conduit to the base of the flexible cannula. During this process, there are moments in which the base of the flexible cannula to which the drug conduit will be connected is exposed to the environment, so it can be contaminated. This inconvenience is especially important when the procedure is carried out by the patient at home, which is common in the treatment of certain diseases.
  • the present invention solves the above problem thanks to the fact that the extraction point of the rigid guide is not the same point to which the drug conduit is subsequently connected.
  • the rigid guide removal point has an automatic sealing means configured to automatically seal the exit hole of the guide just after it has been completely removed.
  • the infusion of the drug is carried out by means of a conduit, called an extension, which is permanently attached to a lateral surface of the flexible cannula. Therefore, the present invention prevents the interior of the flexible cannula from being exposed to the environment, which greatly hinders the entry of contamination due to microorganisms or the like.
  • proxima and distar are interpreted taking as reference the patient. That is, the end of the flexible cannula that is inserted into the patient's skin is the proximal end, and the end of the flexible cannula that is outside the patient's skin is the distal end.
  • drug delivery medium refers to any type of element that allows a drug to be propelled proximally into the patient. It can be, for example, an elastomeric pump, although it also includes gravity-based elements, such as bags hung above the level of the insertion point, syringes or other piston-based elements, etc.
  • the expression "under the skin of a patient” refers to any type of insert for infusion of a drug, including intravenous, subcutaneous, muscular, or other insertion.
  • the invention describes a flexible cannula insertion device comprising, similarly to prior art devices, a rigid guide disposed inside the flexible cannula to allow the insertion of said flexible cannula under the skin of a patient, the rigid guide being removable distally through the distal base of the flexible cannula.
  • the device of the invention further comprises: an automatic sealing means of the distal base of the flexible cannula through which the rigid guide is extracted; and an extension attached to the lateral surface of the flexible cannula for connection with a drug delivery means.
  • the automatic sealing means can be of any type provided that it allows to automatically close the orifice of the distal base of the flexible cannula that is produced when the rigid guide is removed.
  • the sealing means is a silicone plug pierced by a distal portion of the rigid guide.
  • the silicone must have sufficient creep capacity so that, when the user pulls the distal end of the rigid guide, the longitudinal hole of the plug through which the rigid guide passes is closed almost immediately.
  • the closure of the hole will begin to occur just after the passage of the proximal end of the rigid guide, whereby the proximal portion of the hole will be closed even before the guide has been completely removed by the distal end of the hole.
  • this automatic sealing means has the additional advantage of preventing the reintroduction of the rigid guide after it has been removed, which avoids the possible breakage or deterioration of the flexible cannula once it has been inserted.
  • the device of the invention further comprises a fastener attached to a distal end of the rigid guide for easy removal.
  • This clamping element can be, for example, a rigid plastic part firmly fixed to the distal end of the rigid guide, so that the user can grasp said plastic piece to remove the rigid guide.
  • the plastic piece may have a spline or the like to improve the grip by the user.
  • the device of the invention further comprises a dressing to which the flexible cannula is attached. It may be a conventional type dressing consisting of a sheet having a first face provided with a biocompatible adhesive and a second face opposite the first.
  • the flexible cannula may be embedded in the dressing, or fixed to the second face in any manner known in the art.
  • this dressing comprises a transparent window located in its central area such that it encompasses the insertion point of the flexible cannula in the patient's skin. This allows the user to observe the insertion point both to facilitate puncture and to control the area at all times.
  • the dressing comprises a peripheral band made of textile material around the transparent window. This peripheral band allows the arrangement of the adhesive in a simpler way, the central area being transparent without adhesive.
  • the extension is essentially formed by a conduit, normally flexible, which has a proximal end permanently connected to the lateral surface of the flexible cannula in a portion close to its base and a distal end configured for connection to a delivery device of drug.
  • the automatic sealing means hermetically seals the hole through which the rigid guide is removed and the infusion of the drug is carried out through the extension.
  • the connection of the distal end of the extension with the drug delivery means can be carried out in different ways.
  • the extension comprises a bioconnector located at its distal end for connection with the drug delivery means.
  • the extension comprises a luer-lock connection at its distal end for connection with the drug delivery means.
  • the extension comprises a patient fixation element.
  • the fixing element may comprise an adhesive sheet to which a clamp is attached, the inside of which extends the extension.
  • the rigid guide can be made of different materials as long as it has sufficient rigidity to facilitate the introduction of the flexible catheter under the patient's skin.
  • it can be a metal guide.
  • FIG. 1 shows a schematic view of a device according to the present invention.
  • Fig. 1 shows a device (1) according to a schematic top view that allows to appreciate the different elements that compose it.
  • the rigid guide (2) which in this example is metallic, arranged inside the flexible cannula (3).
  • the rigid guide (2) has a proximal end located in the left area of the drawing and a distal end located in the right area of the drawing.
  • the sharp proximal end of the rigid guide (2) is covered by means of a sheath to avoid accidental punctures.
  • the distal end of the rigid guide (2) is fixed to an element (6) of clamping to allow a user to extract it comfortably once the puncture has been performed.
  • the suction element (6) is simply a plastic part firmly connected to the distal end of the rigid guide (2).
  • the piece has an essentially cylindrical shape endowed with a recess in its central diameter in order to facilitate the grip by the user.
  • the flexible cannula (3) also has a proximal end located to the left of the drawing and a distal base (3d) located to the right of the drawing.
  • the flexible cannula (3) can be made of Teflon and have a length of approximately between 13 mm and 17 mm.
  • the proximal end is near the proximal end of the metal guide (2) inside the protective sheath, while the distal base (3d) is covered by an automatic sealing means (4) through which a distal portion passes of the rigid guide (2).
  • the sealing means (4) is formed by an essentially cylindrical silicone plug.
  • the silicone has such properties that allow the rigid guide (2) to be completely removed distally through the cap (4). Once the cylindrical duct through which the rigid guide (2) passes is empty, the silicone tends to flow to fill that space, so that the distal base (3d) of the flexible cannula (3) is sealed tightly from automatic way as soon as the rigid guide (2) is removed after puncture.
  • the flexible cannula (3) is unique to a dressing (7) configured to be fixed to the patient's skin in order to avoid possible puncture site infections.
  • the dressing (7) is formed by a transparent central portion (7a) that allows to observe the evolution of the puncture point and an opaque peripheral portion (7b) made of a textile material to allow reliable adhesion to the patient's skin.
  • the lower face of the dressing (7) can be fully adhesive, including the central portion (7a) and the peripheral portion (7b), or only the peripheral portion (7b) can be adhesive.
  • An extension (5) protruding from the lateral surface of the flexible cannula (3) in a distal portion thereof close to the distal base (3d) allows the infusion of the drug in question.
  • This extension has a distal end (8) with a luer-lock connection provided with a bioconnector to allow connection with a drug delivery means.
  • the device (1) of this example includes a patient fixation element (9) to prevent accidental pulls from detaching the extension (5) or The drive medium.
  • This fixing element (9) can be configured in the manner shown in Fig. 2 by means of an adhesive sheet (9a) on which a clamp (9b) is arranged.
  • the adhesive sheet (9a) is configured to be fixed on the patient's skin, and the clip (9b) is fixed to the adhesive sheet (9a). The user only has to clamp the extension (5) using the clamp (9b).
  • this device (1) is fundamentally the following. First, the user removes the protective sheath and, using the rigid guide (2), punctures and introduces a proximal portion of the flexible cannula (3). Once the flexible cannula (3) is correctly inserted under the patient's skin, the user grabs the element (6) and pulls it until the rigid guide (2) is completely removed. As the proximal end of the rigid guide (2) passes through the silicone plug (4), the silicone flows and filling the hole it leaves in its path. Thus, by the time the rigid guide (2) has been completely removed, the silicone plug (4) already constitutes a tight seal that prevents the entry of contamination or microorganisms. The connection of the drug delivery means to the distal end (8) of the extension (5) can be carried out in advance of the previous steps. The fixing element (9) is used to fix the extension (5) to the patient's skin in order to avoid accidental pulling.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention relates to a device (1) for inserting a flexible cannula, which comprises a rigid guide (2) disposed in the flexible cannula (3) to allow said flexible cannula (3) to be inserted under the skin of a patient, the rigid guide (2) being removable in a distal direction through the distal base (3d) of the flexible cannula (3). The device also comprises: a means (4) for automatically sealing the distal base (3d) of the flexible cannula (3) through which base the rigid guide (2) is removed; and an extension (5) joined to the lateral surface of the flexible cannula (3) for connecting to a means for propelling a drug.

Description

Dispositivo de inserción de cánula flexible DESCRIPCIÓN OBJETO DE LA INVENCIÓN  Flexible cannula insertion device DESCRIPTION OBJECT OF THE INVENTION
La presente invención pertenece en general al campo de la medicina, y más particularmente a los elementos utilizados para la infusión continua de fármacos a un paciente. The present invention belongs in general to the field of medicine, and more particularly to the elements used for continuous infusion of drugs to a patient.
El objeto de la presente invención es un dispositivo diseñado para la inserción una cánula flexible en un paciente para la administración continua de fármacos. The object of the present invention is a device designed for insertion of a flexible cannula in a patient for the continuous administration of drugs.
ANTECEDENTES DE LA INVENCIÓN BACKGROUND OF THE INVENTION
La infusión continua de fármacos a un paciente de forma continua está ampliamente desarrollada en la actualidad. Existen para ello diversos dispositivos diseñado para impulsar de manera continua un fármaco a través de un conducto que termina en una aguja o cánula flexible que se introduce en el paciente bien por vía intravenosa o por vía subcutánea. Un ejemplo de este tipo de dispositivos son las denominadas bombas elastoméricas. Una bomba elastomérica comprende fundamentalmente un reservorio elástico de fármaco capaz de crear una presión positiva continua suficiente como para impulsar el fármaco, un capilar que restringe el flujo de salida del reservorio elástico, y un conducto que permite trasportar dicho flujo de salida hacia el paciente. Otros dispositivos conocidos se basan simplemente en la gravedad para conseguir la impulsión del fármaco. Continuous infusion of drugs to a patient continuously is widely developed today. There are several devices designed to continuously drive a drug through a conduit that ends in a flexible needle or cannula that is introduced into the patient either intravenously or subcutaneously. An example of such devices are the so-called elastomeric pumps. An elastomeric pump essentially comprises an elastic drug reservoir capable of creating a continuous positive pressure sufficient to drive the drug, a capillary that restricts the outflow of the elastic reservoir, and a conduit that allows the said outflow to be transported to the patient. Other known devices simply rely on gravity to achieve drug delivery.
En cualquier caso, es necesaria la utilización de un dispositivo que permita insertar una cánula flexible en el paciente para la infusión del fármaco. Actualmente son conocidos múltiples dispositivos de este tipo. Por ejemplo, puede hacerse referencia al producto comercial denominado Accu-Check Tenderlink. El Accu-Check Tenderlink está formado fundamentalmente por un aposito que se fija sobre la piel del paciente dotado de una guía metálica para una cánula flexible. En primer lugar, se pega una parte del aposito sobre la piel del paciente. A continuación, se utiliza la guía metálica para introducir la cánula en la piel del paciente, después se extrae la guía por la zona posterior del tubo de la cánula flexible. Por último, se conecta el extremo del conducto proveniente dispositivo de impulsión del fármaco mediante un elemento de conexión diseñado al efecto. El documento de patente EP2397180 describe el producto Accu- Check Tenderlink con mayor detalle. In any case, it is necessary to use a device that allows a flexible cannula to be inserted into the patient for infusion of the drug. Currently, multiple devices of this type are known. For example, reference may be made to the commercial product called Accu-Check Tenderlink. The Accu-Check Tenderlink is mainly formed by a dressing that is fixed on the patient's skin equipped with a metal guide for a flexible cannula. First, a part of the dressing is pasted on the patient's skin. Next, the metal guide is used to insert the cannula into the patient's skin, then the guide is removed through the area Rear of the flexible cannula tube. Finally, the end of the conduit from the drug delivery device is connected by means of a connection element designed for this purpose. Patent document EP2397180 describes the Accu-Check Tenderlink product in greater detail.
Sin embargo, los dispositivos tales como el Accu-Check Tenderlink presentan el inconveniente de que la operación de extracción de la cánula metálica y posterior conexión del conducto de fármaco puede permitir la entrada de contaminación. En efecto, una vez introducida la cánula flexible bajo la piel del paciente gracias a la guía metálica, es necesario extraer dicha guía metálica y, a continuación, conectar el conducto de fármaco a la base de la cánula flexible. Durante este proceso, existen unos instantes en los que la base de la cánula flexible a la que se conectará el conducto de fármaco queda expuesta al ambiente, por lo que puede resultar contaminada. Este inconveniente es especialmente importante cuando el procedimiento es llevado a cabo por el propio paciente en su domicilio, lo que es habitual en el tratamiento de determinadas enfermedades. However, devices such as the Accu-Check Tenderlink have the disadvantage that the operation of extraction of the metal cannula and subsequent connection of the drug conduit can allow contamination to enter. Indeed, once the flexible cannula is inserted under the patient's skin thanks to the metal guide, it is necessary to remove said metal guide and then connect the drug conduit to the base of the flexible cannula. During this process, there are moments in which the base of the flexible cannula to which the drug conduit will be connected is exposed to the environment, so it can be contaminated. This inconvenience is especially important when the procedure is carried out by the patient at home, which is common in the treatment of certain diseases.
DESCRIPCIÓN DE LA INVENCIÓN La presente invención resuelve el problema anterior gracias a que el punto de extracción de la guía rígida no es el mismo punto al que posteriormente se conecta el conducto de fármaco. El punto de extracción de la guía rígida presenta un medio de sellado automático configurado para cerrar automáticamente de manera hermética el orificio de salida de la guía justo después de que ésta haya sido completamente extraída. La infusión del fármaco se lleva a cabo por medio de un conducto, denominado alargadera, que está unido de manera permanente a una superficie lateral de la cánula flexible. Por lo tanto, la presente invención evita que el interior de la cánula flexible quede expuesto al ambiente, lo que dificulta enormemente la entrada de contaminación debido a microorganismos o similares. DESCRIPTION OF THE INVENTION The present invention solves the above problem thanks to the fact that the extraction point of the rigid guide is not the same point to which the drug conduit is subsequently connected. The rigid guide removal point has an automatic sealing means configured to automatically seal the exit hole of the guide just after it has been completely removed. The infusion of the drug is carried out by means of a conduit, called an extension, which is permanently attached to a lateral surface of the flexible cannula. Therefore, the present invention prevents the interior of the flexible cannula from being exposed to the environment, which greatly hinders the entry of contamination due to microorganisms or the like.
En este documento, los términos "proxima y "distar se interpretan tomando como referencia el paciente. Es decir, el extremo de la cánula flexible que se introduce en la piel del paciente es el extremo proximal, y el extremo de la cánula flexible que queda fuera de la piel del paciente es el extremo distal. En este documento, el término "medio de impulsión de fármaco" hace referencia a cualquier tipo de elemento que permita impulsar un fármaco en sentido proximal hacia el interior del paciente. Puede tratarse, por ejemplo, de una bomba elastomérica, aunque también incluye elementos basados en la gravedad, como bolsas colgadas por encima del nivel del punto de inserción, jeringas u otros elementos basados en émbolos, etc. In this document, the terms "proxima and" distar are interpreted taking as reference the patient. That is, the end of the flexible cannula that is inserted into the patient's skin is the proximal end, and the end of the flexible cannula that is outside the patient's skin is the distal end. In this document, the term "drug delivery medium" refers to any type of element that allows a drug to be propelled proximally into the patient. It can be, for example, an elastomeric pump, although it also includes gravity-based elements, such as bags hung above the level of the insertion point, syringes or other piston-based elements, etc.
En este documento, la expresión "bajo la piel de un paciente" hace referencia a cualquier tipo de inserción para la infusión de un fármaco, incluyendo inserción intravenosa, subcutánea, muscular, u otras. In this document, the expression "under the skin of a patient" refers to any type of insert for infusion of a drug, including intravenous, subcutaneous, muscular, or other insertion.
La invención describe un dispositivo de inserción de cánula flexible que comprende, de manera similar a los dispositivos de la técnica anterior, una guía rígida dispuesta en el interior de la cánula flexible para permitir la inserción de dicha cánula flexible bajo la piel de un paciente, siendo la guía rígida extraíble en sentido distal a través de la base distal de la cánula flexible. Sin embargo, a diferencia de dichos dispositivos de la técnica anterior, el dispositivo de la invención además comprende: un medio de sellado automático de la base distal de la cánula flexible a través del cual se extrae la guía rígida; y una alargadera unida a la superficie lateral de la cánula flexible para la conexión con un medio de impulsión de fármaco. The invention describes a flexible cannula insertion device comprising, similarly to prior art devices, a rigid guide disposed inside the flexible cannula to allow the insertion of said flexible cannula under the skin of a patient, the rigid guide being removable distally through the distal base of the flexible cannula. However, unlike said prior art devices, the device of the invention further comprises: an automatic sealing means of the distal base of the flexible cannula through which the rigid guide is extracted; and an extension attached to the lateral surface of the flexible cannula for connection with a drug delivery means.
El medio de sellado automático puede ser de cualquier tipo siempre que permita cerrar de manera automática el orificio de la base distal de la cánula flexible que se produce cuando se extrae la guía rígida. En una realización especialmente preferida, el medio de sellado es un tapón de silicona atravesado por una porción distal de la guía rígida. La silicona debe tener una capacidad de fluencia suficiente como para que, cuando el usuario tira del extremo distal de la guía rígida, el orificio longitudinal del tapón a través del cual va pasando la guía rígida se cierre de manera casi inmediata. De ese modo, el cierre del orificio empezará a producirse justo después del paso del extremo proximal de la guía rígida, con lo que la porción proximal del orificio estará cerrada antes incluso de que la guía haya sido extraída completamente por el extremo distal del orificio. Ello impide cualquier posibilidad de entrada de contaminación o microorganismos en el interior de la cánula flexible a través de la cual se realiza la infusión del medicamento. Además, el uso de este medio de sellado automático presenta la ventaja adicional de impedir la reintroducción de la guía rígida después de haber sido extraída, lo que evita la posible rotura o deterioro de la cánula flexible una vez ésta ha sido insertada. The automatic sealing means can be of any type provided that it allows to automatically close the orifice of the distal base of the flexible cannula that is produced when the rigid guide is removed. In a particularly preferred embodiment, the sealing means is a silicone plug pierced by a distal portion of the rigid guide. The silicone must have sufficient creep capacity so that, when the user pulls the distal end of the rigid guide, the longitudinal hole of the plug through which the rigid guide passes is closed almost immediately. Thus, the closure of the hole will begin to occur just after the passage of the proximal end of the rigid guide, whereby the proximal portion of the hole will be closed even before the guide has been completely removed by the distal end of the hole. This prevents any possibility of contamination or microorganisms entering the flexible cannula through which the infusion of the medicine is carried out. In addition, the use of this automatic sealing means has the additional advantage of preventing the reintroduction of the rigid guide after it has been removed, which avoids the possible breakage or deterioration of the flexible cannula once it has been inserted.
De acuerdo con otra realización preferida, el dispositivo de la invención además comprende un elemento de sujeción fijado a un extremo distal de la guía rígida para facilitar su extracción. Este elemento de sujeción puede ser, por ejemplo, una pieza de plástico rígido fijada firmemente al extremo distal de la guía rígida, de manera que el usuario pueda agarrar dicha pieza de plástico para extraer la guía rígida. La pieza de plástico puede tener un estriado o similar para mejorar el agarre por parte del usuario. De acuerdo con otra realización preferida, el dispositivo de la invención comprende además un aposito al que está unida la cánula flexible. Puede tratarse de un aposito de tipo convencional formado por una lámina que tiene una primera cara dotada de un adhesivo biocompatible y una segunda cara opuesta a la primera. La cánula flexible puede estar embebida en el aposito, o bien fijada a la segunda cara de cualquier modo conocido en la técnica. Así, el usuario puede colocar el aposito antes o al mismo tiempo que realiza la punción con ayuda de la guía rígida, minimizando las posibilidades de que se produzca contaminación en el punto de inserción de la cánula flexible. En una realización especialmente preferida de la invención, este aposito comprende una ventana transparente ubicada en su zona central de manera que abarca el punto de inserción de la cánula flexible en la piel del paciente. Ello permite al usuario observar el punto de inserción tanto para facilitar la punción como para controlar la zona en todo momento. En otra realización preferida, el aposito comprende una banda periférica hecha de material textil alrededor de la ventana transparente. Esta banda periférica permite la disposición del adhesivo de una manera más sencilla, pudiendo quedar la zona central transparente sin adhesivo. According to another preferred embodiment, the device of the invention further comprises a fastener attached to a distal end of the rigid guide for easy removal. This clamping element can be, for example, a rigid plastic part firmly fixed to the distal end of the rigid guide, so that the user can grasp said plastic piece to remove the rigid guide. The plastic piece may have a spline or the like to improve the grip by the user. According to another preferred embodiment, the device of the invention further comprises a dressing to which the flexible cannula is attached. It may be a conventional type dressing consisting of a sheet having a first face provided with a biocompatible adhesive and a second face opposite the first. The flexible cannula may be embedded in the dressing, or fixed to the second face in any manner known in the art. Thus, the user can place the dressing before or at the same time as performing the puncture with the help of the rigid guide, minimizing the chances of contamination occurring at the point of insertion of the flexible cannula. In an especially preferred embodiment of the invention, this dressing comprises a transparent window located in its central area such that it encompasses the insertion point of the flexible cannula in the patient's skin. This allows the user to observe the insertion point both to facilitate puncture and to control the area at all times. In another preferred embodiment, the dressing comprises a peripheral band made of textile material around the transparent window. This peripheral band allows the arrangement of the adhesive in a simpler way, the central area being transparent without adhesive.
La alargadera está formada fundamentalmente por un conducto, normalmente flexible, que tiene un extremo proximal conectado de manera permanente a la superficie lateral de la cánula flexible en una porción cercana a su base y un extremo distal configurado para su conexión a un dispositivo de impulsión de fármaco. Así, el medio de sellado automático sella de manera hermética el orificio por el que se extrae la guía rígida y la infusión del fármaco se realiza a través de la alargadera. La unión del extremo distal de la alargadera con el medio de impulsión de fármaco puede realizarse de diferentes modos. Por ejemplo, en una realización preferida de la invención la alargadera comprende un bioconector ubicado en su extremo distal para la conexión con el medio de impulsión de fármaco. En otra realización preferida, la alargadera comprende una conexión luer-lock en su extremo distal para la conexión con el medio de impulsión de fármaco. The extension is essentially formed by a conduit, normally flexible, which has a proximal end permanently connected to the lateral surface of the flexible cannula in a portion close to its base and a distal end configured for connection to a delivery device of drug. Thus, the automatic sealing means hermetically seals the hole through which the rigid guide is removed and the infusion of the drug is carried out through the extension. The connection of the distal end of the extension with the drug delivery means can be carried out in different ways. For example, in a preferred embodiment of the invention, the extension comprises a bioconnector located at its distal end for connection with the drug delivery means. In another preferred embodiment, the extension comprises a luer-lock connection at its distal end for connection with the drug delivery means.
En otra realización preferida de la invención, la alargadera comprende un elemento de fijación a la piel del paciente. De ese modo, se evitan arrancamientos accidentales de la alargadera debido a movimientos del paciente. Por ejemplo, el elemento de fijación puede comprender una lámina adhesiva a la que está fijada una pinza por cuyo interior transcurre la alargadera. In another preferred embodiment of the invention, the extension comprises a patient fixation element. In this way, accidental starts of the extension due to patient movements are avoided. For example, the fixing element may comprise an adhesive sheet to which a clamp is attached, the inside of which extends the extension.
Por último, mencionar que la guía rígida puede fabricarse de diferentes materiales siempre que tenga una rigidez suficiente como para facilitar la introducción del catéter flexible bajo la piel del paciente. Por ejemplo, puede tratarse de una guía metálica. Finally, mention that the rigid guide can be made of different materials as long as it has sufficient rigidity to facilitate the introduction of the flexible catheter under the patient's skin. For example, it can be a metal guide.
BREVE DESCRIPCIÓN DE LAS FIGURAS La Fig. 1 muestra una vista esquemática de un dispositivo de acuerdo con la presente invención. BRIEF DESCRIPTION OF THE FIGURES Fig. 1 shows a schematic view of a device according to the present invention.
REALIZACIÓN PREFERENTE DE LA INVENCIÓN A continuación, se describe un ejemplo de dispositivo (1) de acuerdo con la presente invención haciendo referencia a las figuras adjuntas. Las figuras no están hechas a escala, y sirven únicamente para ilustrar la invención de forma cualitativa. PREFERRED EMBODIMENT OF THE INVENTION Next, an example of a device (1) according to the present invention is described with reference to the attached figures. The figures are not made to scale, and serve only to illustrate the invention qualitatively.
La Fig. 1 muestra un dispositivo (1) según una vista superior esquemática que permite apreciar los diferentes elementos que lo componen. Se puede apreciar la guía (2) rígida, que en este ejemplo es metálica, dispuesta en el interior de la cánula (3) flexible. La guía (2) rígida tiene un extremo proximal ubicado en la zona izquierda del dibujo y un extremo distal ubicado en la zona derecha del dibujo. El extremo proximal afilado de la guía (2) rígida está tapado por medio de una funda para evitar pinchazos accidentales. El extremo distal de la guía (2) rígida, a su vez, está fijado a un elemento (6) de sujeción para permitir que un usuario la pueda extraer cómodamente una vez realizada la punción. En este ejemplo, el elemento (6) de succión es simplemente una pieza plástica conectada firmemente al extremo distal de la guía (2) rígida. La pieza tiene una forma esencialmente cilindrica dotada de un rehundido en su diámetro central con el propósito de facilitar el agarre por parte del usuario. Fig. 1 shows a device (1) according to a schematic top view that allows to appreciate the different elements that compose it. You can see the rigid guide (2), which in this example is metallic, arranged inside the flexible cannula (3). The rigid guide (2) has a proximal end located in the left area of the drawing and a distal end located in the right area of the drawing. The sharp proximal end of the rigid guide (2) is covered by means of a sheath to avoid accidental punctures. The distal end of the rigid guide (2), in turn, is fixed to an element (6) of clamping to allow a user to extract it comfortably once the puncture has been performed. In this example, the suction element (6) is simply a plastic part firmly connected to the distal end of the rigid guide (2). The piece has an essentially cylindrical shape endowed with a recess in its central diameter in order to facilitate the grip by the user.
La cánula (3) flexible también tiene un extremo proximal situado a la izquierda del dibujo y una base distal (3d) situada a la derecha del dibujo. La cánula (3) flexible puede estar hecha de teflón y tener una longitud de aproximadamente entre 13 mm y 17 mm. El extremo proximal está cerca del extremo proximal de la guía (2) metálica en el interior de la funda protectora, mientras que la base distal (3d) está tapada por un medio (4) de sellado automático a través del cual pasa una porción distal de la guía (2) rígida. El medio (4) de sellado está formado por un tapón de silicona de forma esencialmente cilindrica. La silicona tiene unas propiedades tales que permiten que la guía (2) rígida se extraiga completamente en sentido distal a través del tapón (4). Una vez el conducto cilindrico a través del que pasa la guía (2) rígida va quedando vacío, la silicona tiende a fluir para rellenar ese espacio, de manera que la base distal (3d) de la cánula flexible (3) queda sellada herméticamente de manera automática en cuanto se extrae la guía (2) rígida tras la punción. The flexible cannula (3) also has a proximal end located to the left of the drawing and a distal base (3d) located to the right of the drawing. The flexible cannula (3) can be made of Teflon and have a length of approximately between 13 mm and 17 mm. The proximal end is near the proximal end of the metal guide (2) inside the protective sheath, while the distal base (3d) is covered by an automatic sealing means (4) through which a distal portion passes of the rigid guide (2). The sealing means (4) is formed by an essentially cylindrical silicone plug. The silicone has such properties that allow the rigid guide (2) to be completely removed distally through the cap (4). Once the cylindrical duct through which the rigid guide (2) passes is empty, the silicone tends to flow to fill that space, so that the distal base (3d) of the flexible cannula (3) is sealed tightly from automatic way as soon as the rigid guide (2) is removed after puncture.
La cánula (3) flexible está única a un aposito (7) configurado para fijarse a la piel del paciente con el propósito de evitar posibles infecciones en el punto de punción. El aposito (7) está formado por una porción central (7a) transparente que permite observar la evolución del punto de punción y una porción periférica (7b) opaca hecha de un material textil para permitir una adhesión fiable a la piel del paciente. La cara inferior del aposito (7) puede ser adhesiva en su totalidad, incluyendo la porción central (7a) y la porción periférica (7b), o bien puede ser adhesiva únicamente la porción periférica (7b). Una alargadera (5) que sobresale de la superficie lateral de la cánula (3) flexible en una porción distal de la misma cercana a la base distal (3d) permite la infusión del fármaco en cuestión. Esta alargadera tiene un extremo distal (8) con una conexión luer-lock dotada de bioconector para permitir la conexión con un medio de impulsión de fármaco. Además, el dispositivo (1) de este ejemplo incluye un elemento (9) de fijación al paciente para evitar que tirones accidentales desprendan la alargadera (5) o el medio de impulsión. Este elemento (9) de fijación puede estar configurado del modo representado en la Fig. 2 mediante una lámina (9a) adhesiva sobre la que se dispone una pinza (9b). La lámina (9a) adhesiva está configurada para fijarse sobre la piel del paciente, y la pinza (9b) está fijada a la lámina (9a) adhesiva. El usuario sólo tiene que pinzar la alargadera (5) mediante la pinza (9b). The flexible cannula (3) is unique to a dressing (7) configured to be fixed to the patient's skin in order to avoid possible puncture site infections. The dressing (7) is formed by a transparent central portion (7a) that allows to observe the evolution of the puncture point and an opaque peripheral portion (7b) made of a textile material to allow reliable adhesion to the patient's skin. The lower face of the dressing (7) can be fully adhesive, including the central portion (7a) and the peripheral portion (7b), or only the peripheral portion (7b) can be adhesive. An extension (5) protruding from the lateral surface of the flexible cannula (3) in a distal portion thereof close to the distal base (3d) allows the infusion of the drug in question. This extension has a distal end (8) with a luer-lock connection provided with a bioconnector to allow connection with a drug delivery means. In addition, the device (1) of this example includes a patient fixation element (9) to prevent accidental pulls from detaching the extension (5) or The drive medium. This fixing element (9) can be configured in the manner shown in Fig. 2 by means of an adhesive sheet (9a) on which a clamp (9b) is arranged. The adhesive sheet (9a) is configured to be fixed on the patient's skin, and the clip (9b) is fixed to the adhesive sheet (9a). The user only has to clamp the extension (5) using the clamp (9b).
El funcionamiento de este dispositivo (1) es fundamentalmente el siguiente. En primer lugar, el usuario extrae la funda protectora y, con ayuda de la guía (2) rígida, realiza la punción e introduce una porción proximal de la cánula (3) flexible. Una vez la cánula (3) flexible está correctamente introducida bajo la piel del paciente, el usuario agarra el elemento (6) y tira del mismo hasta extraer completamente la guía (2) rígida. A medida que el extremo proximal de la guía (2) rígida va pasando a través del tapón (4) de silicona, la silicona va fluyendo y rellenando el orificio que ésta va dejando a su paso. De ese modo, para el momento en que la guía (2) rígida ha sido completamente extraída, el tapón (4) de silicona ya constituye un cierre hermético que impide la entrada de contaminación o microorganismos. La conexión del medio de impulsión de fármaco al extremo distal (8) de la alargadera (5) puede realizarse con antelación a los pasos anteriores. Se utiliza el elemento (9) de fijación para fijar la alargadera (5) a la piel del paciente con el objeto de evitar tirones accidentales. The operation of this device (1) is fundamentally the following. First, the user removes the protective sheath and, using the rigid guide (2), punctures and introduces a proximal portion of the flexible cannula (3). Once the flexible cannula (3) is correctly inserted under the patient's skin, the user grabs the element (6) and pulls it until the rigid guide (2) is completely removed. As the proximal end of the rigid guide (2) passes through the silicone plug (4), the silicone flows and filling the hole it leaves in its path. Thus, by the time the rigid guide (2) has been completely removed, the silicone plug (4) already constitutes a tight seal that prevents the entry of contamination or microorganisms. The connection of the drug delivery means to the distal end (8) of the extension (5) can be carried out in advance of the previous steps. The fixing element (9) is used to fix the extension (5) to the patient's skin in order to avoid accidental pulling.

Claims

REIVINDICACIONES
1. Dispositivo (1) de inserción de cánula flexible, que comprende una guía (2) rígida dispuesta en el interior de la cánula (3) flexible para permitir la inserción de dicha cánula (3) flexible bajo la piel de un paciente, donde la guía (2) rígida es extraíble en sentido distal a través de la base distal (3d) de la cánula (3) flexible, caracterizado por que además comprende: 1. Flexible cannula insertion device (1), comprising a rigid guide (2) arranged inside the flexible cannula (3) to allow the insertion of said flexible cannula (3) under the skin of a patient, where The rigid guide (2) is removable distally through the distal base (3d) of the flexible cannula (3), characterized in that it also comprises:
- un medio (4) de sellado automático de la base distal (3d) de la cánula (3) flexible a través del cual se extrae la guía (2) rígida; y - a means (4) for automatically sealing the distal base (3d) of the flexible cannula (3) through which the rigid guide (2) is extracted; and
- una alargadera (5) unida a la superficie lateral de la cánula (3) flexible para la conexión con un medio de impulsión de fármaco. - an extension (5) attached to the lateral surface of the flexible cannula (3) for connection with a drug delivery means.
2. Dispositivo (1) de acuerdo con la reivindicación 1 , donde el medio (4) de sellado es un tapón (4) de silicona atravesado por una porción distal de la guía (2) rígida. 2. Device (1) according to claim 1, wherein the sealing means (4) is a silicone plug (4) crossed by a distal portion of the rigid guide (2).
3. Dispositivo (1) de acuerdo con cualquiera de las reivindicaciones anteriores, que además comprende un elemento (6) de sujeción fijado a un extremo distal de la guía (2) rígida para facilitar su extracción. 3. Device (1) according to any of the preceding claims, which also comprises a fastening element (6) fixed to a distal end of the rigid guide (2) to facilitate its extraction.
4. Dispositivo (1) de acuerdo con cualquiera de las reivindicaciones anteriores, que además comprende un aposito (7) al que está unida la cánula flexible (4) 4. Device (1) according to any of the preceding claims, which further comprises a dressing (7) to which the flexible cannula (4) is attached.
5. Dispositivo (1) de acuerdo con la reivindicación 4, donde el aposito (7) comprende una ventana transparente (7a) ubicada en su zona central de manera que abarca el punto de inserción de la cánula (3) flexible en la piel del paciente. 5. Device (1) according to claim 4, wherein the dressing (7) comprises a transparent window (7a) located in its central area so that it covers the insertion point of the flexible cannula (3) into the skin of the patient.
6. Dispositivo (1) de acuerdo con la reivindicación 5, donde el aposito (7) comprende una banda periférica (7b) hecha de material textil alrededor de la ventana transparente (7a). 6. Device (1) according to claim 5, wherein the dressing (7) comprises a peripheral band (7b) made of textile material around the transparent window (7a).
7. Dispositivo (1) de acuerdo con cualquiera de las reivindicaciones anteriores, donde la alargadera (5) comprende un bioconector ubicado en su extremo distal (8) para la conexión con el medio de impulsión de fármaco. 7. Device (1) according to any of the preceding claims, wherein the extension (5) comprises a bioconnector located at its distal end (8) for connection with the drug delivery means.
8. Dispositivo (1) de acuerdo con cualquiera de las reivindicaciones anteriores, donde la alargadera (5) comprende una conexión luer-lock ubicada en su extremo distal (8) para la conexión con el medio de impulsión de fármaco. 8. Device (1) according to any of the preceding claims, wherein The extension (5) comprises a Luer-lock connection located at its distal end (8) for connection with the drug delivery means.
9. Dispositivo (1) de acuerdo con cualquiera de las reivindicaciones anteriores, donde la alargadera comprende un elemento (9) de fijación a la piel del paciente. 9. Device (1) according to any of the preceding claims, where the extension comprises an element (9) for fixing to the patient's skin.
10. Dispositivo (1) de acuerdo con la reivindicación 9, donde el elemento (9) de fijación comprende una lámina adhesiva (9a) a la que está fijada una pinza (9b) por cuyo interior transcurre la alargadera (5). 10. Device (1) according to claim 9, wherein the fixing element (9) comprises an adhesive sheet (9a) to which a clip (9b) is fixed, through whose interior the extension (5) runs.
1 1. Dispositivo (1) de acuerdo con cualquiera de las reivindicaciones anteriores, donde la guía (2) rígida es metálica. 1 1. Device (1) according to any of the previous claims, where the rigid guide (2) is metallic.
PCT/ES2017/070414 2016-06-08 2017-06-07 Device for inserting a flexible cannula WO2017212101A1 (en)

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ES201630803U ES1167983Y (en) 2016-06-08 2016-06-08 Flexible cannula insertion device
ESU201630803 2016-06-08

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2088215A (en) * 1980-06-10 1982-06-09 Wallace Ltd H G Improvements in intravascular devices
EP0239244A1 (en) * 1986-02-25 1987-09-30 Pacesetter Infusion Ltd. Subcutaneous injection set
ES2200035T3 (en) * 1995-03-16 2004-03-01 Becton Dickinson And Company FRONT CONTROL-REFLECTION INDICATOR IN THE PREVIOUS PART OF THE INTRODUCTION NEEDLE BY ONE SINGLE HAND AND CATETER ASSEMBLY.
US20100204652A1 (en) * 2007-07-06 2010-08-12 Ray Morrissey Cannula insertion device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2088215A (en) * 1980-06-10 1982-06-09 Wallace Ltd H G Improvements in intravascular devices
EP0239244A1 (en) * 1986-02-25 1987-09-30 Pacesetter Infusion Ltd. Subcutaneous injection set
ES2200035T3 (en) * 1995-03-16 2004-03-01 Becton Dickinson And Company FRONT CONTROL-REFLECTION INDICATOR IN THE PREVIOUS PART OF THE INTRODUCTION NEEDLE BY ONE SINGLE HAND AND CATETER ASSEMBLY.
US20100204652A1 (en) * 2007-07-06 2010-08-12 Ray Morrissey Cannula insertion device

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