WO2021044285A1 - Safe-handling needle device - Google Patents

Safe-handling needle device Download PDF

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Publication number
WO2021044285A1
WO2021044285A1 PCT/IB2020/058110 IB2020058110W WO2021044285A1 WO 2021044285 A1 WO2021044285 A1 WO 2021044285A1 IB 2020058110 W IB2020058110 W IB 2020058110W WO 2021044285 A1 WO2021044285 A1 WO 2021044285A1
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WO
WIPO (PCT)
Prior art keywords
needle
syringe
safe handling
head
discard
Prior art date
Application number
PCT/IB2020/058110
Other languages
Spanish (es)
French (fr)
Inventor
Mónica MANTILLA OTERO
Dennis Elías NÚÑEZ HUGHES
Original Assignee
Mantilla Otero Monica
Nunez Hughes Dennis Elias
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 Mantilla Otero Monica, Nunez Hughes Dennis Elias filed Critical Mantilla Otero Monica
Publication of WO2021044285A1 publication Critical patent/WO2021044285A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C19/00—Dental auxiliary appliances
    • A61C19/06—Implements for therapeutic treatment
    • A61C19/08—Implements for therapeutic treatment combined with anaesthetising implements
    • 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • 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
    • 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
    • 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 invention relates to accessory devices to introduce agents into the body via subcutaneous, intravenous or intramuscular routes, related to needles, their connection with the syringe or accessories to introduce the needle into the body, keep it in position or dispose of it; particularly with a mechanical device that separates the needle covers, made of a single material for handling and disposing of needles with minimal risk of puncture accident during use in clinical activities, composed of an activation element for removing the needle , placement in the syringe and housing the loaded syringe during use; and a second discard element for separation of the syringe by unscrewing and direct disposal of the needle to the guardian in free fall.
  • a mechanical device that separates the needle covers made of a single material for handling and disposing of needles with minimal risk of puncture accident during use in clinical activities, composed of an activation element for removing the needle , placement in the syringe and housing the loaded syringe during use; and a second discard element for separation of the syringe by
  • Patent US20190151564 "EXTERNAL CAP HAVING NEEDLE PROTECTION CAP REMOVER ELEMENT AND METHOD FOR ASSEMBLING AN INJECTION DEVICE" is known about the invention.
  • AG dated 2019-05-23 which is an injection device that includes a product container with an injection needle, a protective needle cap removably secured to the product container that surrounds the injection needle and seals it. in a sterile manner.
  • the cap is connected to a needle protection cap through an extractor element having a coupling element, in such a way that removal of the cap from the injection device causes removal of the needle protection cap from the product container, where the element coupling is in an engaging position relative to the needle shield cap, where in the engaging position, a section of the needle shield cap is distally arranged in line with the coupling element, characterized in that the lid and the coupling element are coupled in such a way that the lid can be moved relative to the coupling element during removal of the injection device.
  • the new invention has an anterior sterile sheath that covers the sealed needle before use, to minimize the risks of puncture during assembly and disassembly of the syringe from the needle; Likewise, it releases the needle alone and goes directly to the guard without the covers or protectors and is reusable eight times, with built-in witnesses for the record of compliance with uses.
  • the application US20190151561 "INJECTION DEVICE COMPRISING A COVER CAP AND A SYSTEM FOR PREVENTING THE COVER CAP FROM BEING REMOUNTED”, (INJECTION DEVICE THAT INCLUDES A COVER AND A SYSTEM TO PREVENT THE COVER FROM BEING REASSEMBLED) from TECPHARMA LICENSING AG 2019-05-23, is an injection device for dispensing a liquid product, in particular a medicine, includes: a) a casing with a longitudinal axis (L) and a product container, in particular a syringe, provided in the casing , the product container includes a movable plunger, where the plunger can move along the longitudinal axis (L) in a distal direction using a propelling member to distribute the product contained in the product container; b) a cover cap that is mounted on the distal end of the housing and removable from the housing; and c) a mechanism that prevents the cap from being reassembled to the distal
  • the cap (16) has an inverted skirt (32) that extends outward and upward to act as a protective cover to protect a hand when the assembly is held during a needle insertion operation.
  • the new invention is a mechanical device for biomedical use for handling and disposing of needles in any type of guard, composed of an activation element for removing the needle and a second disposal element. It is not a needle disposal system. DESCRIPTION OF THE INVENTION
  • the Safe Handling Needle Device is lightweight for standard use of different gauge needles, does not come into contact with the needle in use, and is reusable with usage guides.
  • the safe handling needle device separates the plastic components of the needle, allowing the subsequent industrial processing of each independent component, avoiding contamination by gases generated from the incineration of the needles within non-separated plastic elements before disposal in the guard and allows disposal of the needle only.
  • the invention is a mechanical device that separates the needle sheaths, made of a single material for handling and disposing of needles with minimal risk of puncture accident during use in clinical activities, composed of an activation element for removing the needle, placement in the syringe and housing the loaded syringe during use; and a second discard element for separation of the syringe by unscrewing and direct disposal of the needle to the guardian in free fall.
  • This device facilitates the direct vision of the user during all the activities described to guarantee biosafety by direct observation.
  • Figure 1 shows an exploded view of the elements of the device that are attached to the needle and its syringe.
  • Figure 2 shows the activation element coupled to the needle and its syringe.
  • Figure 3 shows the discard element attached to the needle and its syringe.
  • Figure 4 shows a front view of the activation element and a view of the two ends of said activation element.
  • the activation element (10) does not come into contact with the needle (11), since the needle (11) remains centered in the longitudinal cavity (12) that runs through the center of the activation element (10); providing biosafety to the user and the patient.
  • the needle (11) is protected by the front cover (13) and by the rear cover (14) and the assembly is carried out in the device, taking the syringe (15) to the needle (11) that is protected within the covers and puncture is avoided when removing the seal (16) and the back cover (14) by screwing the back (17) of the needle (11) onto the front (18) of the syringe (15).
  • the device makes it possible to visually observe through the longitudinal grooves (19) and control the withdrawal of the needle (11) from the front sheath (13) that is screwed onto the syringe (15), keeping the needle in the center of the element. activation (10), avoiding the puncture of the hands with the grip surface (20). Furthermore, the activation element (10) allows positioning and maintaining the syringe (15) with the needle (11) during use and for refilling the carpule.
  • the discard element (21) is placed, which allows the discard of the needle (11) in any type of guard in free fall, in addition to favoring the collection of the front cover (13) and the rear cover (14) for recycling.
  • the discarding of the previous sheath (13) with the needle is avoided when They separate manually before discarding and avoid puncture during unscrewing of the needle (11) from the syringe (15) using the fingerprints of the guardian, when the fingerprints are released.
  • the needle device for mechanical safe handling that separates the needle covers mechanically and is composed of an activation element (10) and a discard element (21) executable on needles (11) of different lengths and gauges.
  • the activation element (10) has a cylindrical shape with longitudinal grooves (19), preferably four longitudinal grooves (19) diametrically opposite lateral to visualize the disassembly of the needle (11) and subsequent assembly to the syringe (15).
  • Said activation element (10) has a distal end (22) with a smaller octagonal hole (23) that houses the needle (11) and its anterior sheath (13) in which it is retained, it has a proximal end (24 ) with a circular hole (25) of greater amplitude that allows the passage of the needle (11), its front sheath (13), the introduction of the front part (18) of the syringe (15) coupled to the rear part (17) from the needle (11).
  • the seal (16) and the posterior sheath (14) are removed, rotating the front sheath (13) in the opposite direction to the rear sheath (14), exposing the rear part (17) of the needle (11); brought to the center of the activation element (10), pulling on the anterior sleeve (13) located outside the distal end (22).
  • the syringe (15) enters the activation element (10) until it meets the needle (11) and with rotary movements of the activation element (10) around the syringe (15), the needle is screwed on.
  • the removal of the needle (11) coupled to the syringe (15), is done smoothly inside the activation element (10) and slides out. This action being visible through the longitudinal grooves (19)
  • the anterior sleeve (13) is kept on the activation element (10), allowing the housing of the syringe (15) during the injection of liquid and is removed by pushing from the distal end (22) towards the proximal end (24), allowing recycling together with the back cover (14), avoiding being discarded together with the needle (11) to the guardian.
  • the discard element (21) has a larger cylindrical shape and is made up of two attachable parts.
  • the second part of the housing (28) is an external component with an upper hole (31) with a receiving thread tip (29), which allows the first part of the head (26) to enter and screw the internal screw cap. .
  • the second part of the casing (28) has lateral longitudinal grooves (33), preferably four diametrically opposite lateral longitudinal grooves (33) that allow the visualization of the activity to be carried out when inserting the first part of the head (26) and the front part (18) from the syringe (15) loaded with the needle (11).
  • the second part of the casing (28) has collapsible witnesses (34) for verification of compliance with the reuse, preferably eight collapsible witnesses (34) diametrically opposed. These collapsible cores (34) can be removed after each use.
  • the syringe (15) with the needle (11) loaded vertically is placed inside part of the casing (28) in its interior through the hole (30) of greater width.
  • the needle (11) reaches the octagonal hole (32) and is retained there.
  • the user holds the needle (11) fixed and rotates the discard element (21) on the syringe (15) until achieving unscrewing the syringe (15) and removing it.
  • the discard element (21) is vertically inverted, leaving the needle (11) towards the bottom; and carried over the mouth of the guardian, the first head part (26) with screw cap is rotated again on the second part of the casing (28), causing the thrust of the needle by free fall within the guardian.
  • the safe handling needle device has its mechanical execution process under ambient temperature conditions that follows the following steps:

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Anesthesiology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dentistry (AREA)
  • Epidemiology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The invention relates to accessory devices for introducing agents into the body subcutaneously, intravenously or intramuscularly, which relate to needles and to the connection thereof to a syringe or accessories for introducing the needle into the body, keep the needle in position or disposing of same. In particular, the invention relates to a mechanical device that separates a sheaths from a needle, and which is made from a single material, for handling and discarding needles with minimal risk of a puncturing accident during use in clinical activities, which device is formed by: an activation element for unsheathing the needle, placing in the syringe and containing the loaded needle during use; and a second discarding element for separating from the syringe by means of unscrewing and disposing of the needle directly into a sharps container, in free fall.

Description

DISPOSITIVO DE AGUJAS DE MANEJO SEGURO SAFE HANDLING NEEDLE DEVICE
SECTOR TECNOLOGICO TECHNOLOGICAL SECTOR
La invención se relaciona dispositivos accesorios para introducir agentes en el cuerpo vía subcutánea, intravenosa o intramuscular, relacionados con agujas, su conexión con la jeringa o accesorios para introducir la aguja en el cuerpo, mantenerla en posición o desecharla; particularmente con un dispositivo mecánico que separa las fundas de la aguja, elaborado en un solo material para manejo y descarte de agujas con mínimo riesgo de accidente por punción durante el uso en actividades clínicas, compuesto por un elemento de activación para el desenfundado de la aguja, colocación en la jeringa y alojamiento de la jeringa cargada durante el uso; y un segundo elemento de descarte para separación de la jeringa por desenrosque y desecho directo de la aguja al guardián en caída libre. The invention relates to accessory devices to introduce agents into the body via subcutaneous, intravenous or intramuscular routes, related to needles, their connection with the syringe or accessories to introduce the needle into the body, keep it in position or dispose of it; particularly with a mechanical device that separates the needle covers, made of a single material for handling and disposing of needles with minimal risk of puncture accident during use in clinical activities, composed of an activation element for removing the needle , placement in the syringe and housing the loaded syringe during use; and a second discard element for separation of the syringe by unscrewing and direct disposal of the needle to the guardian in free fall.
ESTADO DE LA TECNICA STATE OF THE ART
De la invención se conoce la patente US20190151564 “EXTERNAL CAP HAVING NEEDLE PROTECTION CAP REMOVER ELEMENT AND METHOD FOR ASSEMBLING AN INJECTION DEVICE” (TAPA EXTERNA CON ELEMENTO DE EXTRACCIÓN DE TAPA DE PROTECCIÓN DE AGUJA Y MÉTODO PARA ENSAMBLAR UN DISPOSITIVO DE INYECCIÓN) de TECPHARMA LICENSING AG con fecha 2019-05-23, que es un dispositivo de inyección que incluye un recipiente de producto con una aguja de inyección, una tapa protectora de la aguja asegurada de forma desmontable al recipiente de producto que rodea la aguja de inyección y la sella de manera estéril. La tapa está conectada a una tapa de protección de la aguja a través de un elemento extractor que tiene un elemento de acoplamiento, de tal manera que la extracción de la tapa del dispositivo de inyección provoca la extracción de la tapa de protección de la aguja del recipiente del producto, donde el acoplamiento del elemento está en una posición de acoplamiento en relación con la tapa de protección de la aguja, donde en la posición de acoplamiento, una sección de la tapa de protección de la aguja está dispuesta distalmente en línea con el elemento de acoplamiento, caracterizada porque la tapa y el elemento de acoplamiento están acoplados en tal forma que la tapa se puede mover con relación al elemento de acoplamiento durante la extracción del dispositivo de inyección. La nueva invención tiene una funda estéril anterior que recubre la aguja sellada antes del uso, para minimizar los riesgos de punción durante el montaje y desmontaje de la jeringa a la aguja; así mismo, libera la aguja sola y va directamente al guardián sin las fundas o protectores y es reutilizable ocho veces, con testigos incorporados para el registro de cumplimiento de usos. La solicitud US20190151561 “INJECTION DEVICE COMPRISING A COVER CAP AND A SYSTEM FOR PREVENTING THE COVER CAP FROM BEING REMOUNTED”, (DISPOSITIVO DE INYECCIÓN QUE COMPRENDE UNA TAPA Y UN SISTEMA PARA EVITAR QUE LA TAPA SE VUELVA A MONTAR) de TECPHARMA LICENSING AG de fecha 2019-05-23, es un dispositivo de inyección para distribuir un producto líquido, en particular un medicamento, incluye: a) una carcasa con un eje longitudinal (L) y un contenedor de producto, en particular una jeringa, provista en la carcasa, el contenedor del producto incluye un émbolo desplazable, donde el émbolo puede desplazarse a lo largo del eje longitudinal (L) en una dirección distal usando un miembro de propulsión para distribuir el producto contenido en el contenedor del producto; b) una tapa de cubierta que está montada en el extremo distal de la carcasa y que puede retirarse de la carcasa; y c) un mecanismo que impide que la tapa se vuelva a montar en el extremo distal de la carcasa. La nueva invención no distribuye el líquido, es un dispositivo mecánico de uso biomédico para manejo y descarte de agujas, para disminuir el riesgo de accidente por punción durante uso en actividades clínicas. No es un dispositivo de inyección. Patent US20190151564 "EXTERNAL CAP HAVING NEEDLE PROTECTION CAP REMOVER ELEMENT AND METHOD FOR ASSEMBLING AN INJECTION DEVICE" is known about the invention. AG dated 2019-05-23, which is an injection device that includes a product container with an injection needle, a protective needle cap removably secured to the product container that surrounds the injection needle and seals it. in a sterile manner. The cap is connected to a needle protection cap through an extractor element having a coupling element, in such a way that removal of the cap from the injection device causes removal of the needle protection cap from the product container, where the element coupling is in an engaging position relative to the needle shield cap, where in the engaging position, a section of the needle shield cap is distally arranged in line with the coupling element, characterized in that the lid and the coupling element are coupled in such a way that the lid can be moved relative to the coupling element during removal of the injection device. The new invention has an anterior sterile sheath that covers the sealed needle before use, to minimize the risks of puncture during assembly and disassembly of the syringe from the needle; Likewise, it releases the needle alone and goes directly to the guard without the covers or protectors and is reusable eight times, with built-in witnesses for the record of compliance with uses. The application US20190151561 "INJECTION DEVICE COMPRISING A COVER CAP AND A SYSTEM FOR PREVENTING THE COVER CAP FROM BEING REMOUNTED", (INJECTION DEVICE THAT INCLUDES A COVER AND A SYSTEM TO PREVENT THE COVER FROM BEING REASSEMBLED) from TECPHARMA LICENSING AG 2019-05-23, is an injection device for dispensing a liquid product, in particular a medicine, includes: a) a casing with a longitudinal axis (L) and a product container, in particular a syringe, provided in the casing , the product container includes a movable plunger, where the plunger can move along the longitudinal axis (L) in a distal direction using a propelling member to distribute the product contained in the product container; b) a cover cap that is mounted on the distal end of the housing and removable from the housing; and c) a mechanism that prevents the cap from being reassembled to the distal end of the housing. The new invention does not distribute the liquid, it is a mechanical device for biomedical use for handling and disposing of needles, to reduce the risk of puncture accidents during use in clinical activities. It is not an injection device.
La patente antecedente US5187850 “NEEDLE DISPOSAL SYSTEM”, (SISTEMA DE ELIMINACIÓN DE AGUJAS) de JOHN W. MCCAMMON; TREVER L. MOFFET de 1993-02- 23 es un sistema de eliminación de agujas comprende un conjunto manual de tres componentes, a saber, un recipiente desechable (10) que tiene una entrada en su cara superior, una unidad de cabeza (12) asegurable sobre el recipiente (10) y una primera tapa (16) asegurable sobre la unidad principal (12); donde la unidad principal tiene una abertura alineable con la entrada y a través de la cual se pueden alimentar agujas usadas (18) en el recipiente (10) para el paso no retornable del mismo. La primera tapa (16) tiene una abertura (22) alineable con la abertura de la unidad principal. La tapa (16) tiene una falda invertida (32) que se extiende hacia afuera y hacia arriba para actuar como una cubierta protectora para proteger una mano cuando se sostiene el conjunto durante una operación de inserción de aguja. La nueva invención es un dispositivo mecánico de uso biomédico para manejo y descarte de agujas en cualquier tipo de guardián compuesto por un elemento de activación para desenfundado de la aguja y un segundo elemento de descarte. No es un sistema de eliminación de agujas. DESCRIPCIÓN DE LA INVENCIÓN Background patent US5187850 "NEEDLE DISPOSAL SYSTEM", (NEEDLE REMOVAL SYSTEM) by JOHN W. MCCAMMON; TREVER L. MOFFET from 1993-02-23 is a needle disposal system comprising a manual set of three components, namely a disposable container (10) having an inlet on its upper face, a head unit (12) lockable on the container (10) and a first lid (16) lockable on the main unit (12); where the main unit has an aperture alignable with the inlet and through which used needles (18) can be fed into the container (10) for the non-returnable passage of the same. The first cover (16) has an opening (22) alignable with the opening in the main unit. The cap (16) has an inverted skirt (32) that extends outward and upward to act as a protective cover to protect a hand when the assembly is held during a needle insertion operation. The new invention is a mechanical device for biomedical use for handling and disposing of needles in any type of guard, composed of an activation element for removing the needle and a second disposal element. It is not a needle disposal system. DESCRIPTION OF THE INVENTION
El dispositivo de agujas de manejo seguro es liviano para uso estándar de agujas de diferentes calibres, no entra en contacto con la aguja en uso y es reutilizable con guías de uso. The Safe Handling Needle Device is lightweight for standard use of different gauge needles, does not come into contact with the needle in use, and is reusable with usage guides.
El dispositivo de agujas de manejo seguro separa los componentes plásticos de la aguja, permitiendo el proceso industrial posterior de cada componente independiente, evitando la contaminación por gases generados de la incineración de las agujas dentro de elementos plásticos no separados antes del desecho en el guardián y permite el desecho solo de la aguja. The safe handling needle device separates the plastic components of the needle, allowing the subsequent industrial processing of each independent component, avoiding contamination by gases generated from the incineration of the needles within non-separated plastic elements before disposal in the guard and allows disposal of the needle only.
En una mejor manera de la invención, está fabricada en material anti-bacterial, biodegradable o reutilizable industrialmente una vez cumplidos sus usos, siendo el sugerido el ácido poli láctico - PLA y con ocho testigos para verificación de cumplimiento de en cada uno de los ocho usos propuestos. Favorece el descarte de la aguja en todo tipo de recipiente, separando el guardián de la recuperación de las fundas plásticas que la recubre antes de ser usada, facilitando la reutilización; además es un dispositivo de uso manual que contribuye a la disminución del consumo de energía. In a better way of the invention, it is made of antibacterial, biodegradable or industrially reusable material once its uses have been fulfilled, being the suggested polylactic acid - PLA and with eight witnesses for verification of compliance with each of the eight proposed uses. It favors the disposal of the needle in all types of container, separating the guardian from the recovery of the plastic covers that cover it before being used, facilitating reuse; It is also a device for manual use that contributes to reducing energy consumption.
DESCRIPCIÓN TECNICA Y FIGURAS: TECHNICAL DESCRIPTION AND FIGURES:
El invento es un dispositivo mecánico que separa las fundas de la aguja, elaborado en un solo material para manejo y descarte de agujas con mínimo riesgo de accidente por punción durante uso en actividades clínicas, compuesto por un elemento de activación para desenfundado de la aguja, colocación en la jeringa y alojamiento de la jeringa cargada durante el uso; y un segundo elemento de descarte para separación de la jeringa por desenrosque y desecho directo de la aguja al guardián en caída libre. Este dispositivo facilita la visión directa del usuario durante todas las actividades descritas para garantizar la bioseguridad por observación directa. The invention is a mechanical device that separates the needle sheaths, made of a single material for handling and disposing of needles with minimal risk of puncture accident during use in clinical activities, composed of an activation element for removing the needle, placement in the syringe and housing the loaded syringe during use; and a second discard element for separation of the syringe by unscrewing and direct disposal of the needle to the guardian in free fall. This device facilitates the direct vision of the user during all the activities described to guarantee biosafety by direct observation.
Es un dispositivo reusable con guía de usos para su ejecución, lavable con elementos jabonosos y desinfectantes de cada una de las partes que se separan. It is a reusable device with a use guide for its execution, washable with soapy and disinfectant elements of each of the parts that are separated.
Se presenta como un nuevo dispositivo que representa un cambio sustancial en la práctica clínica propendiendo a la consecución de mejorar la seguridad del paciente y del usuario y disminuir las infecciones asociadas o contaminación del usuario por mala disposición de las jeringas en uso, accidente por punción y de desecho. It is presented as a new device that represents a substantial change in clinical practice tending to the achievement of improving patient and user safety and reduce associated infections or user contamination due to poor disposition of syringes in use, puncture and waste accidents.
Para una mejor comprensión de los elementos del dispositivo se presentan las siguientes figuras que aclaran la invención: For a better understanding of the elements of the device, the following figures are presented that clarify the invention:
BREVE DESCRIPCIÓN DE FIGURAS: BRIEF DESCRIPTION OF FIGURES:
La figura 1 muestra un despiece de los elementos del dispositivo que se acoplan a la aguja y su jeringa. Figure 1 shows an exploded view of the elements of the device that are attached to the needle and its syringe.
La figura 2 muestra el elemento de activación acoplado a la aguja y su jeringa. Figure 2 shows the activation element coupled to the needle and its syringe.
La figura 3 muestra el elemento de descarte acoplado a la aguja y su jeringa. Figure 3 shows the discard element attached to the needle and its syringe.
La figura 4 muestra una vista frontal del elemento de activación y una vista de los dos extremos de dicho elemento de activación. Figure 4 shows a front view of the activation element and a view of the two ends of said activation element.
El elemento de activación (10) no entra en contacto con la aguja (11), ya que la aguja (11 ) queda centrada en la cavidad longitudinal (12) que recorre el centro del elemento de activación (10); brindando bioseguridad al usuario y al paciente. The activation element (10) does not come into contact with the needle (11), since the needle (11) remains centered in the longitudinal cavity (12) that runs through the center of the activation element (10); providing biosafety to the user and the patient.
La aguja (11) se encuentra protegida por la funda anterior (13) y por la funda posterior (14) y se realiza el ensamble en el dispositivo, llevando la jeringa (15) a la aguja (11) que se encuentra protegida dentro las fundas y se evita el pinchazo al retirar el sellado (16) y la funda posterior (14) enroscando la parte posterior (17) de la aguja (11) en la parte frontal (18) de la jeringa (15). The needle (11) is protected by the front cover (13) and by the rear cover (14) and the assembly is carried out in the device, taking the syringe (15) to the needle (11) that is protected within the covers and puncture is avoided when removing the seal (16) and the back cover (14) by screwing the back (17) of the needle (11) onto the front (18) of the syringe (15).
El dispositivo permite observar visualmente por medio de las ranuras longitudinales (19) y controlar el retiro de la aguja (11) de la funda anterior (13) que se encuentra enroscada en la jeringa (15), manteniendo la aguja en el centro del elemento de activación (10), evitando el pinchazo de las manos con la superficie de agarre (20). Además, el elemento de activación (10) permite colocar y mantener la jeringa (15) con la aguja (11 ) durante el uso y para recarga de la carpule. The device makes it possible to visually observe through the longitudinal grooves (19) and control the withdrawal of the needle (11) from the front sheath (13) that is screwed onto the syringe (15), keeping the needle in the center of the element. activation (10), avoiding the puncture of the hands with the grip surface (20). Furthermore, the activation element (10) allows positioning and maintaining the syringe (15) with the needle (11) during use and for refilling the carpule.
Para retirar la jeringa (15) de la aguja (11 ) de manera indirecta, se coloca el elemento de descarte (21 ), que permite el descarte de la aguja (11 ) en cualquier tipo de guardián en caída libre, además de favorecer la recolección de la funda anterior (13) y de la funda posterior (14) para reciclarlas. Se evita el descarte de la funda anterior (13) con la aguja, cuando no se separan manualmente antes del descarte y evita punzarse durante el desenroscado de la aguja (11) de la jeringa (15) usando las huellas del guardián, cuando se suelta de las huellas. El dispositivo de agujas de manejo seguro mecánico que separa las fundas de la aguja mecánicamente y se compone de un elemento de activación (10) y de un elemento de descarte (21) ejecutable en agujas (11) de diferente longitud y calibre. To withdraw the syringe (15) from the needle (11) indirectly, the discard element (21) is placed, which allows the discard of the needle (11) in any type of guard in free fall, in addition to favoring the collection of the front cover (13) and the rear cover (14) for recycling. The discarding of the previous sheath (13) with the needle is avoided when They separate manually before discarding and avoid puncture during unscrewing of the needle (11) from the syringe (15) using the fingerprints of the guardian, when the fingerprints are released. The needle device for mechanical safe handling that separates the needle covers mechanically and is composed of an activation element (10) and a discard element (21) executable on needles (11) of different lengths and gauges.
El elemento de activación (10) tiene forma cilindrica con ranuras longitudinales (19), preferiblemente cuatro ranuras longitudinales (19) laterales diametralmente opuestas para visualizar el desensamble de la aguja (11) y posterior ensamble a la jeringa (15). Dicho elemento de activación (10) tiene un extremo distal (22) con un orifico octogonal (23) de menor amplitud que aloja la aguja (11 ) y su funda anterior (13) en la cual se retiene, tiene un extremo proximal (24) con un orificio circular (25) de mayor amplitud que permite el paso de la aguja (11), de su funda anterior (13), la introducción de la parte frontal (18) de la jeringa (15) acoplada a la parte posterior (17) de la aguja (11). The activation element (10) has a cylindrical shape with longitudinal grooves (19), preferably four longitudinal grooves (19) diametrically opposite lateral to visualize the disassembly of the needle (11) and subsequent assembly to the syringe (15). Said activation element (10) has a distal end (22) with a smaller octagonal hole (23) that houses the needle (11) and its anterior sheath (13) in which it is retained, it has a proximal end (24 ) with a circular hole (25) of greater amplitude that allows the passage of the needle (11), its front sheath (13), the introduction of the front part (18) of the syringe (15) coupled to the rear part (17) from the needle (11).
Se realiza el retiro del sellado (16) y de la funda posterior (14), rotando la funda anterior (13) en sentido contrario a la funda posterior (14), exponiéndose la parte posterior (17) de la aguja (11 ); llevada al centro del elemento de activación (10), haciendo tracción en la funda anterior (13) ubicada fuera del extremo distal (22). The seal (16) and the posterior sheath (14) are removed, rotating the front sheath (13) in the opposite direction to the rear sheath (14), exposing the rear part (17) of the needle (11); brought to the center of the activation element (10), pulling on the anterior sleeve (13) located outside the distal end (22).
La jeringa (15) entra dentro del elemento de activación (10) hasta encontrar la aguja (11) y con movimientos rotatorios del elemento de activación (10) alrededor de la jeringa (15), la aguja es enroscada. El desenfundado de la aguja (11) acoplada a la jeringa (15), se realiza suavemente dentro del elemento de activación (10) y se desliza para salir. Siendo visible esta acción por medio de las ranuras longitudinales (19) The syringe (15) enters the activation element (10) until it meets the needle (11) and with rotary movements of the activation element (10) around the syringe (15), the needle is screwed on. The removal of the needle (11) coupled to the syringe (15), is done smoothly inside the activation element (10) and slides out. This action being visible through the longitudinal grooves (19)
La funda anterior (13) se mantiene en el elemento de activación (10), permitiendo el alojamiento de la jeringa (15) durante la inyección de líquido y es removida por empuje desde el extremo distal (22) hacia extremo proximal (24), permitiendo el reciclaje junto con la funda posterior (14), evitando ser desechada junto con la aguja (11) al guardián. The anterior sleeve (13) is kept on the activation element (10), allowing the housing of the syringe (15) during the injection of liquid and is removed by pushing from the distal end (22) towards the proximal end (24), allowing recycling together with the back cover (14), avoiding being discarded together with the needle (11) to the guardian.
El elemento de descarte (21) tiene forma cilindrica de mayor tamaño y se integra de dos partes acoplables. Una primera parte del cabezal (26) con tapa-rosca interna con un cuerpo (27) que se ubica dentro de una segunda parte de la carcasa (28) con punta de rosca receptora (29) y un orifico circular concéntrico (30) en su extremo opuesto por donde entra la jeringa (25). La segunda parte de la carcasa (28) es un componente externo con un orificio superior (31) con punta de rosca receptora (29), que permite a la primera parte del cabezal (26) la entrada y enroscado de la tapa-rosca interna. En su otro extremo, tiene un orifico circular concéntrico (30) con mayor tamaño, que aloja la parte frontal (18) de la jeringa (15) cargada con la aguja (11 ) y dos centímetros e internamente tiene, un orifico octagonal (32) que recibe el aditamento de la aguja (11 ). La segunda parte de la carcasa (28) tiene ranuras longitudinales laterales (33), preferiblemente cuatro ranuras longitudinales laterales (33) diametralmente opuestas que permiten la visualización de la actividad a realizar al insertar la primera parte del cabezal (26) y la parte frontal (18) de la jeringa (15) cargada con la aguja (11 ). The discard element (21) has a larger cylindrical shape and is made up of two attachable parts. A first part of the head (26) with an internal screw-cap with a body (27) that is located inside a second part of the casing (28) with a receiving thread tip (29) and a concentric circular hole (30) in its opposite end where the syringe (25) enters. The second part of the housing (28) is an external component with an upper hole (31) with a receiving thread tip (29), which allows the first part of the head (26) to enter and screw the internal screw cap. . At its other end, it has a larger concentric circular hole (30) that houses the front part (18) of the syringe (15) loaded with the needle (11) and two centimeters and internally has an octagonal hole (32 ) that receives the needle attachment (11). The second part of the casing (28) has lateral longitudinal grooves (33), preferably four diametrically opposite lateral longitudinal grooves (33) that allow the visualization of the activity to be carried out when inserting the first part of the head (26) and the front part (18) from the syringe (15) loaded with the needle (11).
La segunda parte de la carcasa (28) tiene testigos colapsibles (34) para verificación del cumplimiento del reúso, preferiblemente ocho testigos colapsibles (34) diametralmente opuestos. Estos testigos colapsibles (34) pueden ser removidos luego de cada uso. The second part of the casing (28) has collapsible witnesses (34) for verification of compliance with the reuse, preferably eight collapsible witnesses (34) diametrically opposed. These collapsible cores (34) can be removed after each use.
La primera parte del cabezal (26) con tapa-rosca interna con un cuerpo (27) que se ubica dentro de una segunda parte de la carcasa (28) por su parte superior. Se coloca la jeringa (15) con la aguja (11 ) cargada en forma vertical dentro de parte de la carcasa (28) en su interior por el orificio (30) de mayor amplitud. La aguja (11 ) llega hasta el orifico octagonal (32) quedando allí retenida. The first part of the head (26) with an internal screw-cap with a body (27) that is located inside a second part of the casing (28) from its upper part. The syringe (15) with the needle (11) loaded vertically is placed inside part of the casing (28) in its interior through the hole (30) of greater width. The needle (11) reaches the octagonal hole (32) and is retained there.
Para el retiro de la jeringa (15) de la aguja (11) retenida en el orificio octagonal (32), el usuario sostiene fija la aguja (11 ) y rota el elemento de descarte (21 ) sobre la jeringa (15) hasta lograr el desenrosque de la jeringa (15) y su retiro. To remove the syringe (15) from the needle (11) retained in the octagonal hole (32), the user holds the needle (11) fixed and rotates the discard element (21) on the syringe (15) until achieving unscrewing the syringe (15) and removing it.
Para el descarte de la aguja (11) en el guardián, se invierte verticalmente el elemento de descarte (21), quedando la aguja (11) hacia la parte inferior; y llevada sobre la boca del guardián, se gira nuevamente primera parte cabezal (26) con tapa-rosca sobre la segunda parte de la carcasa (28), produciendo el empuje de la aguja por caída libre dentro del guardián. To dispose of the needle (11) in the guard, the discard element (21) is vertically inverted, leaving the needle (11) towards the bottom; and carried over the mouth of the guardian, the first head part (26) with screw cap is rotated again on the second part of the casing (28), causing the thrust of the needle by free fall within the guardian.
El dispositivo de agujas de manejo seguro tiene su proceso de ejecución mecánico en condiciones de temperatura ambiente que sigue los siguientes pasos: The safe handling needle device has its mechanical execution process under ambient temperature conditions that follows the following steps:
Ubicación de la aguja (11 ) dentro del elemento de activación (10) para retiro de la funda posterior (14), y exposición de la aguja (11) en su parte posterior (17), con desplazamiento de la aguja (11) dentro del dispositivo. Enroscado de la jeringa (25) en la aguja (11) dentro del dispositivo, permitiendo realizar y visualizar el posterior retiro de la aguja (11) de forma suave y segura manteniéndose la funda anterior (13) dentro del dispositivo. Location of the needle (11) within the activation element (10) for removal of the rear sheath (14), and exposure of the needle (11) at its rear (17), with movement of the needle (11) within Of the device. Threading the syringe (25) on the needle (11) inside the device, allowing the subsequent removal of the needle (11) to be carried out and visualized in a smooth and safe way, keeping the anterior sheath (13) inside the device.
Retiro de la aguja (11) en uso dentro de la funda anterior (13) durante la actividad clínica de inyección. Removal of the needle (11) in use within the anterior sheath (13) during the clinical injection activity.
Ubicación de la jeringa (25) con la aguja (11) dentro del elemento de descarte (21) en posición vertical, con la aguja (11) dentro del orificio octagonal (32) interno. Desenrosque del elemento de descarte (21 ) de la jeringa (15) y su retiro, manteniendo la aguja (11 ) en el interior del elemento de descarte (21 ). Eliminación de la aguja (11) en el guardián desde el elemento de descarte (21) con giro de la primera parte del cabezal (26) con tapa-rosca con empuje de la aguja (11 ) por caída libre dentro del guardián. Location of the syringe (25) with the needle (11) inside the discard element (21) in a vertical position, with the needle (11) inside the internal octagonal hole (32). Unscrew the discard element (21) from the syringe (15) and remove it, keeping the needle (11) inside the discard element (21). Elimination of the needle (11) in the guard from the discard element (21) with rotation of the first part of the head (26) with screw cap with push of the needle (11) by free fall inside the guard.

Claims

REIVINDICACIONES
1. Dispositivo de agujas de manejo seguro que separa las fundas de la aguja mecánicamente CARACTERIZADO por un elemento de activación (10) y un elemento de descarte (21 ) ejecutable en agujas (11 ) de diferente longitud y calibre; donde el elemento de activación (10) tiene forma cilindrica con ranuras longitudinales (19) laterales para visualizar el desensamble de la aguja (11) y posterior ensamble a la jeringa (15) y tiene un extremo distal (22) con un orifico octogonal (23) que aloja la aguja (11) y su funda anterior (13), y un extremo proximal (24) con un orificio circular (25) que da paso de la aguja (11 ), de su funda anterior (13), y la introducción de la parte frontal (18) de la jeringa (15) acoplada a la parte posterior (17) de la aguja (11); donde el elemento de descarte (21) tiene forma cilindrica y se integra de dos partes acoplables: Una primera parte el cabezal (26) con tapa-rosca interna con un cuerpo (27) que se ubica dentro de una segunda parte de la carcasa (28) con punta de rosca receptora (29) y con un orifico circular concéntrico (30) en su extremo opuesto por donde entra la jeringa (25). 1. Safe handling needle device that mechanically separates the needle sheaths CHARACTERIZED by an activation element (10) and a discard element (21) executable on needles (11) of different length and gauge; where the activation element (10) has a cylindrical shape with lateral longitudinal grooves (19) to visualize the disassembly of the needle (11) and subsequent assembly to the syringe (15) and has a distal end (22) with an octagonal hole ( 23) that houses the needle (11) and its anterior sheath (13), and a proximal end (24) with a circular hole (25) that gives way for the needle (11), its anterior sheath (13), and the introduction of the front part (18) of the syringe (15) coupled to the rear part (17) of the needle (11); where the discard element (21) has a cylindrical shape and is made up of two attachable parts: A first part is the head (26) with internal screw-cap with a body (27) that is located inside a second part of the casing ( 28) with a receiving thread tip (29) and with a concentric circular hole (30) at its opposite end where the syringe (25) enters.
2. Dispositivo de agujas de manejo seguro de acuerdo con la reivindicación 1 , CARACTERIZADO por la funda anterior (13) que rota en sentido contrario a la funda posterior (14) exponiéndose la parte posterior (17) de la aguja (11), haciendo tracción en la funda anterior (13) ubicada fuera del extremo distal (22). 2. Safe handling needle device according to claim 1, CHARACTERIZED by the front sheath (13) that rotates in the opposite direction to the rear sheath (14) exposing the rear part (17) of the needle (11), making traction on the anterior sheath (13) located outside the distal end (22).
3. Dispositivo de agujas de manejo seguro de acuerdo con la reivindicación 1 , CARACTERIZADO porque la segunda parte de la carcasa (28) es un componente externo con un orificio superior (31) con punta de rosca receptora (29), que permite a la primera parte cabezal (26) la entrada y enroscado tapa-rosca interna y en su otro extremo tiene un orifico circular concéntrico (30) que aloja la parte frontal (18) de la jeringa (15) cargada con la aguja (11) y dos centímetros e internamente tiene un orifico octagonal (32) que recibe el aditamento de la aguja (11 ). 3. Safe handling needle device according to claim 1, CHARACTERIZED in that the second part of the housing (28) is an external component with an upper hole (31) with a receiving thread tip (29), which allows the first head part (26) the inlet and screwed cap-internal thread and at its other end has a concentric circular hole (30) that houses the front part (18) of the syringe (15) loaded with the needle (11) and two centimeters and internally it has an octagonal hole (32) that receives the needle attachment (11).
4. Dispositivo de agujas de manejo seguro de acuerdo con la reivindicación 1 ,4. Safe handling needle device according to claim 1,
CARACTERIZADO porque la segunda parte de la carcasa (28) tiene ranuras longitudinales laterales (33), que permiten la visualización de la actividad a realizar, con la primera parte del cabezal (26) y la parte frontal (18) de la jeringa (15) cargada con la aguja (11) insertadas. CHARACTERIZED in that the second part of the casing (28) has lateral longitudinal grooves (33), which allow the visualization of the activity to be carried out, with the first part of the head (26) and the front part (18) of the syringe (15 ) loaded with the needle (11) inserted.
5. Dispositivo de agujas de manejo seguro de acuerdo con la reivindicación 1 ,5. Safe handling needle device according to claim 1,
CARACTERIZADO porque la segunda parte de carcasa (28) tiene testigos colapsibles (34) para verificación de cumplimiento del reúso. CHARACTERIZED in that the second casing part (28) has collapsible witnesses (34) for verification of compliance with reuse.
6. Dispositivo de agujas de manejo seguro de acuerdo con la reivindicación 1 ,6. Safe handling needle device according to claim 1,
CARACTERIZADO porque la primera parte del cabezal (26) con tapa-rosca interna con un cuerpo (27) que se ubica dentro de una segunda parte de carcasa (28) por su parte superior. CHARACTERIZED because the first part of the head (26) with internal screw cap with a body (27) that is located inside a second casing part (28) at its upper part.
7. Dispositivo de agujas de manejo seguro de acuerdo con la reivindicación 1 ,7. Safe handling needle device according to claim 1,
CARACTERIZADO porque dentro parte de la carcasa (28) en su interior por el orificio (30) está la jeringa (15) con la aguja (11) cargada en forma vertical, y la aguja (11 ) está retenida en un orifico octagonal (32). CHARACTERIZED because inside part of the casing (28) inside the hole (30) is the syringe (15) with the needle (11) loaded vertically, and the needle (11) is retained in an octagonal hole (32 ).
8. Dispositivo de agujas de manejo seguro de acuerdo con la reivindicación 1 ,8. Safe handling needle device according to claim 1,
CARACTERIZADO porque el elemento de descarte (21) rota sobre la jeringa (15). CHARACTERIZED in that the discard element (21) rotates on the syringe (15).
9. Dispositivo de agujas de manejo seguro de acuerdo con la reivindicación 1 , CARACTERIZADO porque la primera parte del cabezal (26) con tapa-rosca gira sobre la segunda parte de la carcasa (28) produciendo el empuje de la aguja por caída libre dentro del guardián. 9. Safe handling needle device according to claim 1, CHARACTERIZED in that the first part of the head (26) with screw cap rotates on the second part of the housing (28) producing the thrust of the needle by free fall inside of the guardian.
10. Dispositivo de agujas de manejo seguro CARACTERIZADO porque tiene su proceso de ejecución que sigue los siguientes pasos: - Ubicación de la aguja (11) dentro del elemento de activación (10) para retiro de la funda posterior (14), y exposición de la aguja (11) en su parte posterior (17), con desplazamiento de la aguja (11) dentro del dispositivo. 10. Safe handling needle device CHARACTERIZED because it has its execution process that follows the following steps: - Location of the needle (11) inside the activation element (10) for removal of the back cover (14), and exposure of the needle (11) in its rear part (17), with movement of the needle (11) within the device.
Enroscado de la jeringa (25) en la aguja (11) dentro del dispositivo, permitiendo realizar y visualizar el posterior retiro de la aguja (11) de forma suave y segura. manteniéndose la funda anterior (13) dentro del dispositivo. Screwing the syringe (25) on the needle (11) inside the device, allowing the subsequent removal of the needle (11) to be carried out and visualized in a smooth and safe way. keeping the front cover (13) inside the device.
Retiro de la aguja (11) en uso dentro de la funda anterior (13) durante actividad clínica de inyección. Removal of the needle (11) in use within the anterior sheath (13) during clinical injection activity.
Ubicación de la jeringa (25) con la aguja (11) dentro del elemento de descarte (21) en posición vertical, con la aguja (11) dentro del orificio octagonal (32) interno. - Desenrosque del elemento de descarte (21 ) de la jeringa (15) y su retiro manteniendo la aguja (11 ) en el interior del elemento de descarte (21 ). Location of the syringe (25) with the needle (11) inside the discard element (21) in a vertical position, with the needle (11) inside the internal octagonal hole (32). - Unscrew the discard element (21) from the syringe (15) and remove it, keeping the needle (11) inside the discard element (21).
Eliminación de la aguja (11) en el guardián desde el elemento de descarte (21) con giro de la primera parte del cabezal (26) con tapa-rosca con empuje de la aguja (11 ) por caída libre dentro del guardián. Elimination of the needle (11) in the guard from the discard element (21) with rotation of the first part of the head (26) with screw cap with push of the needle (11) by free fall inside the guard.
PCT/IB2020/058110 2019-09-06 2020-09-01 Safe-handling needle device WO2021044285A1 (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5308582A (en) * 1993-02-11 1994-05-03 Serra Louis M Syringe capping and uncapping device
US5312346A (en) * 1993-02-16 1994-05-17 Han Medical Designs, Inc. Needle removing device
US20070173772A1 (en) * 2004-02-14 2007-07-26 Liversidge Barry P Medical injector handling device
WO2010113388A1 (en) * 2009-03-31 2010-10-07 株式会社みくに工業 Container for collecting needle to be discarded and part for collecting needle to be discarded

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5308582A (en) * 1993-02-11 1994-05-03 Serra Louis M Syringe capping and uncapping device
US5312346A (en) * 1993-02-16 1994-05-17 Han Medical Designs, Inc. Needle removing device
US20070173772A1 (en) * 2004-02-14 2007-07-26 Liversidge Barry P Medical injector handling device
WO2010113388A1 (en) * 2009-03-31 2010-10-07 株式会社みくに工業 Container for collecting needle to be discarded and part for collecting needle to be discarded

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