WO2015101690A1 - Air-occlusion device for drip systems for administering serum and/or medication - Google Patents

Air-occlusion device for drip systems for administering serum and/or medication Download PDF

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Publication number
WO2015101690A1
WO2015101690A1 PCT/ES2014/070987 ES2014070987W WO2015101690A1 WO 2015101690 A1 WO2015101690 A1 WO 2015101690A1 ES 2014070987 W ES2014070987 W ES 2014070987W WO 2015101690 A1 WO2015101690 A1 WO 2015101690A1
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WO
WIPO (PCT)
Prior art keywords
air
chamber
medication
serum
patient
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PCT/ES2014/070987
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Spanish (es)
French (fr)
Inventor
Carlos ESTEVE PIÑEIRO
Original Assignee
Esteve Piñeiro Carlos
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Application filed by Esteve Piñeiro Carlos filed Critical Esteve Piñeiro Carlos
Publication of WO2015101690A1 publication Critical patent/WO2015101690A1/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
    • 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
    • A61M5/36—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 with means for eliminating or preventing injection or infusion of air into body
    • A61M5/40—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 with means for eliminating or preventing injection or infusion of air into body using low-level float-valve to cut off media flow from reservoir
    • 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
    • A61M39/22—Valves or arrangement of valves
    • A61M39/24—Check- or non-return valves
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1411—Drip chambers
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16886—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body for measuring fluid flow rate, i.e. flowmeters
    • A61M5/1689—Drip counters
    • 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
    • A61M5/36—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 with means for eliminating or preventing injection or infusion of air into 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3123—Details having air entrapping or venting means, e.g. purging channels in pistons
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/128—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated valves

Definitions

  • the present invention refers to a method of air occlusion, constituted from a valve with specific characteristics, and recommended for use in serum infusion systems and / or medications during the stay hospital and hemodialysis.
  • the object of this invention is to provide a solution hitherto unknown for several inconveniences that will be discussed later, mainly, it is intended to achieve a final result that prevents the entry of air when the drugs or sera that a patient demands are administered intravenously.
  • the device in question provides essential novelty characteristics and notable advantages over the known and used means for the same purposes in the current state of the art.
  • the intravenous delivery of substances is made possible when, through a disposable infusion system (dropper), the container, whose material is glass or plastic, that contains the solution to be perfused through a plug is passed through of rubber or similar.
  • a disposable infusion system the container, whose material is glass or plastic, that contains the solution to be perfused through a plug is passed through of rubber or similar.
  • the column of air contained in the drip chamber and on the continent itself is the one that makes a downward push, and makes it possible for the substance to be administered to the patient.
  • the ambient air which logically occupies a space in the serum system, is replaced by the serum / medication to be infused; two zones will be observed in the drip chamber, half occupied by liquid and half occupied by air.
  • the total of the liquid is infused, it is the air due to pressure differences (in the case of a serum connected directly to the patient's pathway), which again replaces the entire dropper system and empties it completely, which causes the patient's blood to return through said system in a retrograde sense and pose problems such as coagulation of said blood in areas that are not disposable, such as the patient's pathway.
  • the occluder proposed by the invention solves in a fully satisfactory manner the above-mentioned problem, providing a series of advantageous and novel features, and without that this supposes any reduction of its benefits in other aspects.
  • the proposed invention aims to provide an economical, ecological, practical, simple and easy-to-use solution, the effect of which would be more adequate control over perfusion systems during intravenous administration of sera and / or medications, better protecting the patient and optimizing the same. Time available resources.
  • the present invention has its field of application in the health sector, and more specifically in that of nursing and hemodialysis devices.
  • an injection device that can operate continuously and comprises: - two independent power supplies of at least one liquid intended to be injected into a patient through a tubing, - a device upper injection, which involves a first feeding tube, a second feeding tube and joining means that connect each of the feeding tubes, first and second, to one of the power supplies, and - a lower device of injection, which comprises a lower tube and a liquid pumping means, the said lower tube joining the above-mentioned pumping means to the patient, - the above-mentioned injection device further comprising unique and solidary connection means of those of feeding, first and second, which can be connected to the pumping means, - further comprising the aforementioned injection device, for each of the power supplies, means for interrupting the flow, course or circulation of the liquid and means for detecting that the injection of the liquid contained in the power supply has ended, characterized by the fact that each power supply is an injection bottle, that the tilting of one power source to the other is performed automatically because the
  • document ES 2 234 009 provides a valve for hemostasis comprising: (a) a valve body having a proximal end to receive an operating device and a distant end to connect to a guide catheter; (b) a through interior space in said valve body between said proximal and distant ends, through which through interior space an operating device is introduced until it penetrates said guide catheter; (c) a chamber in said valve body, which surrounds said through interior space, said chamber being filled with a pressurized fluid; (d) a collapsible membrane, located along a part of said through interior space, constructed and arranged such that the pressure of the fluid in said chamber helps to seal said collapsible membrane around said operating device; characterized by (e) means for mechanically deforming said collapsible membrane, whereby the sealing of said collapsible membrane around said operating device is further assisted by said mechanical deformation means.
  • valves for hemostasis used in diagnostic procedures, therapy and vascular intervention and more particularly for the sealing mechanisms of such devices and related systems, including those for washing, however, it does not provide solutions to the inconvenience of entry of air in disposable infusion systems.
  • a perfusion device that forms a unitary closed-loop system, comprising a bag formed by a flexible envelope defining an inner chamber and by perfusion means in fluidic communication with the inner chamber through a tube connected to an outlet orifice of the bag, said inner chamber being provided with partitioning means that are positioned to form a first and second compartments that contain or are intended to contain respectively a first and a second solutions, said compartments being in fluidic communication with the orifice respectively according to a first and according to a second flow paths, the second flow path leading to the first compartment, said first compartment consisting of an upper chamber that is disposed above the second compartment, and a lower chamber that is arranged, at least in part, at the height and / or below the second compartment, the reversible flow shutter interposing in the second flow path, said shutter being suitable, depending on the difference of pressure between the top and bottom of the second flow path, to prevent the flow of the second solution during the infusion of the contents of the upper chamber and
  • the aforementioned document refers to a gravity perfusion device that forms a unitary closed-loop system, however, like the document discussed above, it also does not solve the drawbacks mentioned in this specification, since it lacks a capable valve to prevent the entry of air into the system.
  • a gravity infusion set that is exactly the same as any other type of dropper, except for its membrane located at the base of the drip chamber.
  • Said special 15 micron pore membrane in the drip chamber prevents air from entering the tube at the end of the solution of the container.
  • the fact that the filter of the drip chamber has the size of 15 microns is not responsible for preventing it from being emptied, but its special mobility (up / down) that occludes the liquid outlet orifice towards the tube of the dropper This does nothing but keep the tube filled with the serum or medication that is being infused, thus preventing air from flowing into the patient on a hospital stay or on dialysis treatment.
  • This system has the following drawbacks: a) not all medication is administered, as part of it is inside the said tube and is not administered; b) it is much more expensive that dripper systems commonly used; c) when time passes, after administering the solution, it is checked how the blood refluxes along the tube and mixes with the liquid inside, which is a source of possible accidental contamination in nursing handling.
  • US 201301 16653 A1 proposes an alternative design of the drip chamber in gravity infusion equipment. It works by adding a seal of a deformable and soft material.
  • the seal floats when there is liquid in the drip chamber and when the infusion vessel is emptied, causing the level of the liquid in the drip chamber to fall, the seal drops and the liquid outlet collapses into the dropper tube with what the liquid contained in this line does not flow to the patient but is contained in said tube.
  • the float has a flexible, circumferentially arranged fin that provides a low pressure seal around the outlet of the coupling chamber therewith.
  • the float is generally conical in the profile and engages with a connection profile in the chamber outlet.
  • the entire medication is not administered either, it is more expensive than the drip systems of usual use, and the blood refluxes along the line of the dropper, mixing it with the liquid inside , which is a source of possible accidental contamination in nursing manipulation.
  • a small volume device capable of preventing the entry of air into a perfusion circuit is obtained.
  • the occluder prevents the patient's blood from returning and problems such as blood clotting occur in areas that are not disposable, such as the patient's pathway.
  • the valve prevents the lines from clotting and losing all their blood content, with the repercussions that this entails for the patient.
  • the organizational and human resources aspect is optimized by not requiring the presence and constant attention of nursing staff, as well as avoiding the use of electronic systems that are much more expensive.
  • the present invention is constituted from the following elements:
  • a preferably cylindrical body connected by two zones, one to the area of medication infusion and / or serum provided in the machinery and another to the dropper system by means of an appropriate connection means at each end, houses in its chamber a central semicircle and two placed in opposite directions whose start / end are the connecting ends, the lower central zone being free of said shapes.
  • the chamber is provided with a diametral membrane deformable by fluid pressure, fixed from one end to the other longitudinally with respect to said chamber. In the lower central area there is also a perforation that allows the correct functioning of the system.
  • a preferred embodiment of the proposed invention is constituted from the following elements: a preferably cylindrical body (1), connected by two zones, one to the infusion zone (2) of medication and / or serum provided in the machinery and another to the dropper system (3) by means of an appropriate connection means at each end, houses in its chamber a central semicircle (5) and two placed in opposite directions (4) whose start / end are the connection ends, being free of said forms the lower central zone.
  • the chamber is provided with a diametral membrane (6) deformable by fluid pressure, fixed from one end to the other longitudinally with respect to said chamber.
  • a perforation (7) that allows the correct functioning of the system.

Abstract

The invention concerns a method of occluding air by way of a valve having special features, and recommended for use in drip systems for administering serum and/or medication during hospitalization and haemodialysis.

Description

OCLUSIONADOR DE AIRE PARA SISTEMAS DE INFUSIÓN DE SUERO Y/O MEDICACIÓN  AIR OCLUSIONER FOR SERUM INFUSION SYSTEMS AND / OR MEDICATION
OBJETO DE LA INVENCIÓN OBJECT OF THE INVENTION
La presente invención, tal como se indica en el título, se refiere a un método de oclusión de aire, constituido a partir de una válvula con características específicas, y preconizada para su uso en sistemas de infusión de suero y/o medicamentos durante la estancia hospitalaria y la hemodiálisis.  The present invention, as indicated in the title, refers to a method of air occlusion, constituted from a valve with specific characteristics, and recommended for use in serum infusion systems and / or medications during the stay hospital and hemodialysis.
El objeto de esta invención es aportar una solución hasta ahora desconocida para varios inconvenientes que se comentarán más adelante, principalmente, se pretende lograr un resultado final que impida la entrada de aire cuando se administra por vía intravenosa los medicamentos o sueros que demanda un paciente.  The object of this invention is to provide a solution hitherto unknown for several inconveniences that will be discussed later, mainly, it is intended to achieve a final result that prevents the entry of air when the drugs or sera that a patient demands are administered intravenously.
El dispositivo en cuestión aporta esenciales características de novedad y notables ventajas con respecto a los medios conocidos y utilizados para los mismos fines en el estado actual de la técnica.  The device in question provides essential novelty characteristics and notable advantages over the known and used means for the same purposes in the current state of the art.
En la actualidad, la suministración por vía intravenosa de sustancias se hace posible cuando por medio de un sistema de perfusión desechable (gotero), se atraviesa el recipiente, cuyo material es cristal o plástico, que contiene la solución a perfundir a través de un tapón de caucho o similar. La columna de aire contenida en la cámara de goteo y en el propio continente es la que realiza un empuje hacia abajo, y hace posible que la sustancia se administre al paciente.  At present, the intravenous delivery of substances is made possible when, through a disposable infusion system (dropper), the container, whose material is glass or plastic, that contains the solution to be perfused through a plug is passed through of rubber or similar. The column of air contained in the drip chamber and on the continent itself is the one that makes a downward push, and makes it possible for the substance to be administered to the patient.
Durante el proceso de purgado, que lo hace el enfermero, el aire del ambiente, que lógicamente ocupa un espacio en el sistema de suero, es sustituido por el suero/medicación a infundir; se observarán así en la cámara de goteo dos zonas, la mitad ocupada por líquido y la otra mitad por aire. Una vez es infundido el total del líquido, es el aire por diferencia de presiones (en el caso de un suero conectado directamente a la vía del paciente), el que de nuevo sustituye la totalidad del sistema de gotero y lo vacía por completo, lo que ocasiona que la sangre del paciente retorne por dicho sistema en sentido retrógrado y plantee problemas como la coagulación de dicha sangre en zonas que no sean desechables, como por ejemplo, la vía del paciente. Los inconvenientes son aún más graves cuando el gotero está colocado en serie con una máquina para realizar tratamientos de hemodiálisis, pues en lugar de infundirse el suero/medicación por gravedad, es la máquina a través de una bomba que realiza depresión, la que se encarga de succionar e infundir al mismo tiempo, a una velocidad de 400ml/min, tanto la sangre como la medicación del paciente. Esto presenta el grave inconveniente de que, cuando el líquido se acaba, el aire que se encuentra presente en el continente y en todo el sistema de gotero, pasa a lo largo del sistema de montaje de la maquinaria, con lo que puede coagularse la sangre contenida en las líneas, con las repercusiones que ello conlleva para el paciente. During the purging process, which is done by the nurse, the ambient air, which logically occupies a space in the serum system, is replaced by the serum / medication to be infused; two zones will be observed in the drip chamber, half occupied by liquid and half occupied by air. Once the total of the liquid is infused, it is the air due to pressure differences (in the case of a serum connected directly to the patient's pathway), which again replaces the entire dropper system and empties it completely, which causes the patient's blood to return through said system in a retrograde sense and pose problems such as coagulation of said blood in areas that are not disposable, such as the patient's pathway. The disadvantages are even more serious when the dropper is placed in series with a machine to perform hemodialysis treatments, because instead of infusing the serum / gravity medication, it is the machine through a pump that performs depression, which is responsible for to suck and infuse at the same time, at a speed of 400ml / min, both the blood and the medication of the patient. This presents the serious disadvantage that, when the liquid runs out, the air that is present in the continent and throughout the dripper system, passes along the machinery assembly system, with which the blood can clot contained in the lines, with the repercussions that this entails for the patient.
Estos sistemas actuales, si bien cumplen de forma plenamente satisfactoria la función para la que han sido previstos, presentan como problema fundamental el hecho de carecer de características que impidan el paso de aire al administrar dichos productos, sin la necesidad de contar con la presencia constante de personal cualificado, y con la posibilidad de graves consecuencias, tanto a nivel económico, organizativo, y por supuesto, para la salud de los pacientes.  These current systems, although they fulfill the function for which they have been provided in a fully satisfactory manner, present as a fundamental problem the fact that they lack the characteristics that prevent the passage of air when administering said products, without the need to have a constant presence of qualified personnel, and with the possibility of serious consequences, both economically, organizationally, and of course, for the health of patients.
El oclusionador que la invención propone, resuelve de forma plenamente satisfactoria la problemática anteriormente expuesta, aportando una serie de ventajosas y novedosas características, y sin que ello suponga merma alguna de sus prestaciones en otros aspectos. The occluder proposed by the invention, solves in a fully satisfactory manner the above-mentioned problem, providing a series of advantageous and novel features, and without that this supposes any reduction of its benefits in other aspects.
La invención propuesta pretende aportar una solución económica, ecológica, práctica, sencilla y de fácil utilización, cuyo efecto sería un control más adecuado sobre los sistemas de perfusión durante la administración intravenosa de sueros y/o medicamentos, protegiendo mejor al paciente y optimizando al mismo tiempo los recursos disponibles.  The proposed invention aims to provide an economical, ecological, practical, simple and easy-to-use solution, the effect of which would be more adequate control over perfusion systems during intravenous administration of sera and / or medications, better protecting the patient and optimizing the same. Time available resources.
La presente invención tiene su campo de aplicación en el sector sanitario, y más específicamente en el de los dispositivos de enfermería y hemodiálisis.  The present invention has its field of application in the health sector, and more specifically in that of nursing and hemodialysis devices.
ANTECEDENTES DE LA INVENCIÓN BACKGROUND OF THE INVENTION
En el estado de la técnica encontramos algunos documentos relacionados con la invención en cuestión, aunque ninguno de ellos aporta las mismas características ventajosas ni resuelve eficazmente los inconvenientes existentes.  In the state of the art we find some documents related to the invention in question, although none of them provide the same advantageous characteristics nor effectively solve the existing drawbacks.
Así, en el documento ES 2 175 122 encontramos un dispositivo de inyección que puede funcionar continuamente y comprende: - dos fuentes de alimentación independientes de, al menos, un líquido destinado a ser inyectado a un paciente a través de una tubuladura, - un dispositivo superior de inyección, que comporta un primer tubo de alimentación, un segundo tubo de alimentación y unos medios de unión que unen cada uno de los tubos de alimentación, primero y segundo, a una de las fuentes de alimentación, y - un dispositivo inferior de inyección, que comprende un tubo inferior y unos medios de bombeo del líquido, uniendo el susodicho tubo inferior los susodichos medios de bombeo al paciente, - comprendiendo además el susodicho dispositivo de inyección superior unos medios de conexión únicos y solidarios de los de alimentación, primero y segundo, los cuales se pueden empalmar a los medios de bombeo, - comprendiendo, además, el susodicho dispositivo de inyección, para cada una de las fuentes de alimentación, unos medios de interrupción del flujo, curso o circulación del líquido y unos medios para detectar que la inyección del líquido contenido en la fuente de alimentación ha terminado, caracterizado, por el hecho de que cada fuente de alimentación es un frasco de inyección, de que el basculado de una fuente de alimentación a la otra se realiza automáticamente debido a que los susodichos medios para detectar que ha terminado la inyección del líquido contenido en la fuente de alimentación mandan el cierre de los medios de interrupción del flujo del líquido de esta fuente de alimentación, de una parte, y la apertura de los medios de interrupción de la otra fuente de alimentación, de otra parte, y por el hecho de que los medios para detectar que se ha terminado la inyección del líquido contenido en la fuente de alimentación, son unos medios para detectar que la fuente de alimentación está vacía y comprenden un detector de aire. Thus, in document ES 2 175 122 we find an injection device that can operate continuously and comprises: - two independent power supplies of at least one liquid intended to be injected into a patient through a tubing, - a device upper injection, which involves a first feeding tube, a second feeding tube and joining means that connect each of the feeding tubes, first and second, to one of the power supplies, and - a lower device of injection, which comprises a lower tube and a liquid pumping means, the said lower tube joining the above-mentioned pumping means to the patient, - the above-mentioned injection device further comprising unique and solidary connection means of those of feeding, first and second, which can be connected to the pumping means, - further comprising the aforementioned injection device, for each of the power supplies, means for interrupting the flow, course or circulation of the liquid and means for detecting that the injection of the liquid contained in the power supply has ended, characterized by the fact that each power supply is an injection bottle, that the tilting of one power source to the other is performed automatically because the aforementioned means for detecting that the injection of the liquid contained in the power supply has ended orders the closure of the means for interrupting the flow of the liquid from this power supply, of a part, and the opening of the interruption means of the other power supply, of another part, and by the fact that the means to detect that the injection has been terminated With the liquid contained in the power supply, they are means for detecting that the power supply is empty and comprises an air detector.
Este documento aporta un sistema que si bien está provisto de un detector de aire, carece de una válvula de oclusión tal como la invención que se propone, dejando así irresueltos los inconvenientes comentados anteriormente.  This document provides a system that, although it is provided with an air detector, lacks an occlusion valve such as the proposed invention, thus leaving the above-mentioned drawbacks unresolved.
Por otro lado, en el documento ES 2 234 009 se aporta una válvula para hemostasia que comprende: (a) un cuerpo de la válvula que tiene un extremo próximo para recibir un dispositivo operativo y un extremo distante para conectar a un catéter guía; (b) un espacio interior pasante en dicho cuerpo de la válvula entre dichos extremos próximo y distante, por cuyo espacio interior pasante se introduce un dispositivo operativo hasta que penetra en dicho catéter guía; (c) una cámara en dicho cuerpo de la válvula, la cual rodea a dicho espacio interior pasante, estando dicha cámara llena de un fluido a presión; (d) una membrana colapsable, situada a lo largo de una parte de dicho espacio interior pasante, construida y dispuesta de tal modo que la presión del fluido en dicha cámara ayuda a sellar dicha membrana colapsable alrededor de dicho dispositivo operativo; caracterizada por (e) unos medios para deformar mecánicamente dicha membrana colapsable, por lo cual el sellado de dicha membrana colapsable alrededor de dicho dispositivo operativo está asistido además por dichos medios mecánicos de deformación. On the other hand, document ES 2 234 009 provides a valve for hemostasis comprising: (a) a valve body having a proximal end to receive an operating device and a distant end to connect to a guide catheter; (b) a through interior space in said valve body between said proximal and distant ends, through which through interior space an operating device is introduced until it penetrates said guide catheter; (c) a chamber in said valve body, which surrounds said through interior space, said chamber being filled with a pressurized fluid; (d) a collapsible membrane, located along a part of said through interior space, constructed and arranged such that the pressure of the fluid in said chamber helps to seal said collapsible membrane around said operating device; characterized by (e) means for mechanically deforming said collapsible membrane, whereby the sealing of said collapsible membrane around said operating device is further assisted by said mechanical deformation means.
Este documento define unas válvulas para hemostasia utilizadas en procedimientos de diagnóstico, terapia e intervención vascular, y más particularmente para los mecanismos de sellado de tales dispositivos y a los sistemas relacionados, incluyendo los de lavado, sin embargo, no aporta soluciones al inconveniente de la entrada de aire en sistemas desechables de perfusión.  This document defines valves for hemostasis used in diagnostic procedures, therapy and vascular intervention, and more particularly for the sealing mechanisms of such devices and related systems, including those for washing, however, it does not provide solutions to the inconvenience of entry of air in disposable infusion systems.
A su vez, en el documento ES 2 374 279 se reivindica un dispositivo de perfusión que forma un sistema unitario de circuito cerrado, que comprende una bolsa formada por una envoltura flexible que define una cámara interior y por unos medios de perfusión en comunicación fluídica con la cámara interior a través de un tubo conectado a un orificio de salida de la bolsa, dicha cámara interior estando provista de unos medios de compartimentación que están colocados para formar un primer y un segundo compartimentos que contienen o están destinados a contener respectivamente una primera y una segunda soluciones, dichos compartimentos estando en comunicación fluídica con el orificio respectivamente según una primera y según una segunda trayectorias de flujo, la segunda trayectoria de flujo desembocando en el primer compartimento, constando dicho primer compartimento de una cámara superior que está dispuesto por encima del segundo compartimento, y una cámara inferior que está dispuesto, al menos en parte, a la altura y/o por debajo del segundo compartimento, interponiéndose el obturador reversible de flujo en la segunda trayectoria de flujo, siendo apto dicho obturador, en función de la diferencia de presión entre la parte superior y la parte inferior de la segunda trayectoria de flujo, para impedir el flujo de la segunda solución durante la perfusión del contenido de la cámara superior y para permitir el flujo de la segunda solución durante la perfusión del contenido de la cámara inferior. In turn, in document ES 2 374 279 a perfusion device is claimed that forms a unitary closed-loop system, comprising a bag formed by a flexible envelope defining an inner chamber and by perfusion means in fluidic communication with the inner chamber through a tube connected to an outlet orifice of the bag, said inner chamber being provided with partitioning means that are positioned to form a first and second compartments that contain or are intended to contain respectively a first and a second solutions, said compartments being in fluidic communication with the orifice respectively according to a first and according to a second flow paths, the second flow path leading to the first compartment, said first compartment consisting of an upper chamber that is disposed above the second compartment, and a lower chamber that is arranged, at least in part, at the height and / or below the second compartment, the reversible flow shutter interposing in the second flow path, said shutter being suitable, depending on the difference of pressure between the top and bottom of the second flow path, to prevent the flow of the second solution during the infusion of the contents of the upper chamber and to allow the flow of the second solution during the infusion of the content of the lower chamber
El documento citado se refiere a un dispositivo de perfusión por gravedad que forma un sistema unitario de circuito cerrado, sin embargo, al igual que el documento comentado anteriormente, éste tampoco resuelve los inconvenientes mencionados en esta memoria descriptiva, ya que carece de una válvula capaz de impedir la entrada de aire al sistema.  The aforementioned document refers to a gravity perfusion device that forms a unitary closed-loop system, however, like the document discussed above, it also does not solve the drawbacks mentioned in this specification, since it lacks a capable valve to prevent the entry of air into the system.
También es conocido en el estado de la técnica un equipo de infusión por gravedad que es exactamente igual que cualquier otro tipo de gotero, salvo por su membrana situada en la base de la cámara de goteo. Dicha membrana especial de 15 mieras de poro en la cámara de goteo, evita que entre aire en el tubo al terminar la solución del contenedor. El hecho de que el filtro de la cámara de goteo tenga el tamaño de 15 mieras no es el responsable de evitar que él no se vacíe, sino su especial movilidad (arriba/abajo) que ocluye el orificio de salida del líquido hacia el tubo del gotero. Esto no hace otra cosa que mantener el tubo lleno del suero o medicación que se está infundiendo, evitando que pase así el aire hacia el paciente de estancia hospitalaria o en tratamiento de diálisis. Este sistema presenta los siguientes inconvenientes: a) no se administra toda la medicación, pues parte de ésta, queda en el interior del citado tubo y no es administrada; b) es mucho más caro que los sistemas de gotero de uso habitual; c) cuando pasa el tiempo, tras administrar la solución, se comprueba como la sangre refluye a lo largo del tubo y se mezcla con el líquido de su interior, lo que es fuente de posible contaminación accidental en la manipulación de enfermería. Also known in the state of the art is a gravity infusion set that is exactly the same as any other type of dropper, except for its membrane located at the base of the drip chamber. Said special 15 micron pore membrane in the drip chamber prevents air from entering the tube at the end of the solution of the container. The fact that the filter of the drip chamber has the size of 15 microns is not responsible for preventing it from being emptied, but its special mobility (up / down) that occludes the liquid outlet orifice towards the tube of the dropper This does nothing but keep the tube filled with the serum or medication that is being infused, thus preventing air from flowing into the patient on a hospital stay or on dialysis treatment. This system has the following drawbacks: a) not all medication is administered, as part of it is inside the said tube and is not administered; b) it is much more expensive that dripper systems commonly used; c) when time passes, after administering the solution, it is checked how the blood refluxes along the tube and mixes with the liquid inside, which is a source of possible accidental contamination in nursing handling.
Alternativamente, el documento US 201301 16653 A1 propone un diseño alternativo de la cámara de goteo en el equipo de infusión por gravedad. Funciona mediante la adición de un sello de un material deformable y suave. El sello flota cuando hay líquido en la cámara de goteo y cuando se vacía el recipiente de infusión, haciendo que el nivel del líquido en la cámara de goteo caiga, el sello desciende y colapsa la salida de líquido hacia el tubo del gotero con lo que el líquido contenido en esta línea no fluye hacia el paciente sino que queda contenido en dicho tubo. Preferiblemente, el flotador presenta una aleta flexible, dispuesta circunferencialmente que proporciona un sello de baja presión alrededor de la salida de la cámara de acoplamiento con el mismo. Preferiblemente también el flotador es generalmente cónico en el perfil y se compromete con un perfil de conexión en la salida de cámara. Al igual que en el caso anterior, con esta invención tampoco se administra toda la medicación, resulta más cara que los sistemas de gotero de uso habitual, y la sangre refluye a lo largo de la línea del gotero mezclándose ésta con el líquido de su interior, lo que es fuente de posible contaminación accidental en la manipulación de enfermería.  Alternatively, US 201301 16653 A1 proposes an alternative design of the drip chamber in gravity infusion equipment. It works by adding a seal of a deformable and soft material. The seal floats when there is liquid in the drip chamber and when the infusion vessel is emptied, causing the level of the liquid in the drip chamber to fall, the seal drops and the liquid outlet collapses into the dropper tube with what the liquid contained in this line does not flow to the patient but is contained in said tube. Preferably, the float has a flexible, circumferentially arranged fin that provides a low pressure seal around the outlet of the coupling chamber therewith. Preferably also the float is generally conical in the profile and engages with a connection profile in the chamber outlet. As in the previous case, with this invention the entire medication is not administered either, it is more expensive than the drip systems of usual use, and the blood refluxes along the line of the dropper, mixing it with the liquid inside , which is a source of possible accidental contamination in nursing manipulation.
Así vemos, que hasta ahora no se conocía un oclusionador de aire que por sus novedosas características resuelva los inconvenientes mencionados anteriormente tanto en cuanto a los documentos citados como a otras invenciones o métodos tradicionales que encontramos en el estado de la técnica. Tomando en consideración los casos mencionados y analizados los argumentos conjugados, con la invención que se propone en este documento se da lugar a un resultado final en el que se aportan aspectos diferenciadores significativos frente al estado de la técnica actual, y donde se aportan una serie de avances en los elementos ya conocidos con sus ventajas correspondientes. Thus, we see that until now an air occluder was not known which, due to its novel characteristics, resolves the aforementioned problems both in terms of the documents cited and other inventions or traditional methods found in the state of the art. Taking into consideration the cases mentioned and analyzing the conjugate arguments, with the invention proposed in this document, a final result is produced in which significant differentiating aspects are provided in relation to the state of the art, and where a series is provided. of advances in the elements already known with their corresponding advantages.
En particular:  In particular:
Se obtiene un dispositivo de reducido volumen capaz de impedir la entrada de aire en un circuito de perfusión.  A small volume device capable of preventing the entry of air into a perfusion circuit is obtained.
En un sistema de perfusión tradicional, el oclusionador impide que la sangre del paciente retorne y que se produzcan problemas como la coagulación de dicha sangre en zonas que no son desechables, como por ejemplo, la vía del paciente. En una maquinaria de diálisis, la válvula evita que puedan coagularse las líneas y perder todo su contenido hemático, con las repercusiones que ello conlleva para el paciente.  In a traditional perfusion system, the occluder prevents the patient's blood from returning and problems such as blood clotting occur in areas that are not disposable, such as the patient's pathway. In a dialysis machine, the valve prevents the lines from clotting and losing all their blood content, with the repercussions that this entails for the patient.
Se obtiene un dispositivo de bajo coste pero de altas prestaciones.  A low cost but high performance device is obtained.
Se optimiza el aspecto organizativo y de recursos humanos al no requerir la presencia y atención constante del personal de enfermería, así como evitar el uso de sistemas electrónicos que son mucho más caros.  The organizational and human resources aspect is optimized by not requiring the presence and constant attention of nursing staff, as well as avoiding the use of electronic systems that are much more expensive.
Evita posibles daños en equipos médicos y reduce los costes de material desechable. DESCRIPCIÓN DE LA INVENCIÓN Prevents possible damage to medical equipment and reduces the costs of disposable material. DESCRIPTION OF THE INVENTION
Así, la presente invención está constituida a partir de los siguientes elementos:  Thus, the present invention is constituted from the following elements:
Un cuerpo preferiblemente cilindrico, conectado por dos zonas, una a la zona de infusión de medicación y/o suero provista en la maquinaria y otra al sistema de gotero mediante un medio de conexión apropiado en cada extremo, alberga en su cámara una semicircunferencia central y dos colocadas en sentidos opuestos cuyo inicio/fin son los extremos de conexión, quedando libre de dichas formas la zona central inferior. La cámara está provista de una membrana diametral deformable por presión del fluido, fijada de un extremo al otro de forma longitudinal con respecto a dicha cámara. En la zona inferior central también se halla una perforación que permite el correcto funcionamiento del sistema.  A preferably cylindrical body, connected by two zones, one to the area of medication infusion and / or serum provided in the machinery and another to the dropper system by means of an appropriate connection means at each end, houses in its chamber a central semicircle and two placed in opposite directions whose start / end are the connecting ends, the lower central zone being free of said shapes. The chamber is provided with a diametral membrane deformable by fluid pressure, fixed from one end to the other longitudinally with respect to said chamber. In the lower central area there is also a perforation that allows the correct functioning of the system.
El sistema funciona mediante la deformación de la zona central de la membrana elástica, producida por la entrada forzada de una sustancia líquida que crea un túnel virtual de paso, sin embargo, una vez finalizada la presencia de dicha sustancia, la membrana vuelve a su estado de reposo oclusionando el paso de aire al pegarse esta a la pared de la semicircunferencia superior; este hecho se produce gracias a la actuación de la presión atmosférica (entra por la zona inferior taladrada) y a la propia elasticidad de la membrana que tiende a recuperar su forma original. Si paralelamente a estos dos hechos físicos dejamos que la válvula trabaje boca abajo la gravedad ayudaría a la recuperación del reposo de la membrana; la menor densidad del aire es otro factor a tener en cuenta por su incapacidad de no deformar la membrana. BREVE DESCRIPCION DE LOS DIBUJOS The system works by deformation of the central area of the elastic membrane, produced by the forced entry of a liquid substance that creates a virtual tunnel of passage, however, once the presence of said substance is finished, the membrane returns to its state resting occluding the passage of air when stuck is to the wall of the upper semicircle; This fact occurs thanks to the performance of atmospheric pressure (enters through the lower drilled area) and the elasticity of the membrane itself that tends to recover its original shape. If, in parallel to these two physical facts, we let the valve work upside down, gravity would help the recovery of membrane rest; The lower air density is another factor to consider due to its inability not to deform the membrane. BRIEF DESCRIPTION OF THE DRAWINGS
Para una mejor comprensión de esta memoria descriptiva se acompaña un dibujo que a modo de ejemplo no limitativo, describen una realización preferida de la invención:  For a better understanding of this specification, a drawing is attached which, by way of non-limiting example, describes a preferred embodiment of the invention:
Figura 1 .- Vista en alzado  Figure 1 .- Elevation view
Figura 2.- Vista en corte  Figure 2.- Section view
En dichas figuras se destacan los siguientes elementos numerados:  These figures include the following numbered elements:
1 . Cuerpo cilindrico  one . Cylindrical body
2. Conexión a zona de infusión  2. Connection to infusion zone
3. Conexión a sistema de gotero  3. Connection to dripper system
4. Semicircunferencias laterales  4. Side semicircles
5. Semicircunferencia central  5. Central half circle
6. Membrana  6. Membrane
7. Perforación  7. Drilling
Una realización preferida de la invención propuesta, se constituye a partir de los siguientes elementos: un cuerpo preferiblemente cilindrico (1 ), conectado por dos zonas, una a la zona de infusión (2) de medicación y/o suero provista en la maquinaria y otra al sistema de gotero (3) mediante un medio de conexión apropiado en cada extremo, alberga en su cámara una semicircunferencia central (5) y dos colocadas en sentidos opuestos (4) cuyo inicio/fin son los extremos de conexión, quedando libre de dichas formas la zona central inferior. La cámara está provista de una membrana (6) diametral deformable por presión del fluido, fijada de un extremo al otro de forma longitudinal con respecto a dicha cámara. En la zona inferior central también se halla una perforación (7) que permite el correcto funcionamiento del sistema. A preferred embodiment of the proposed invention is constituted from the following elements: a preferably cylindrical body (1), connected by two zones, one to the infusion zone (2) of medication and / or serum provided in the machinery and another to the dropper system (3) by means of an appropriate connection means at each end, houses in its chamber a central semicircle (5) and two placed in opposite directions (4) whose start / end are the connection ends, being free of said forms the lower central zone. The chamber is provided with a diametral membrane (6) deformable by fluid pressure, fixed from one end to the other longitudinally with respect to said chamber. In the lower central area there is also a perforation (7) that allows the correct functioning of the system.

Claims

REIVINDICACIONES
1 . - OCLUSIONADOR DE AIRE PARA SISTEMAS DE INFUSIÓN DE SUERO Y/O MEDICACIÓN, caracterizado por estar constituido a partir de un cuerpo preferiblemente cilindrico, conectado por dos zonas, una a la zona de infusión de medicación y/o suero provista en la maquinaria, y otra al sistema de gotero mediante un medio de conexión apropiado en cada extremo, y que alberga en su cámara una semicircunferencia central y dos colocadas en sentidos opuestos cuyo inicio/fin son los extremos de conexión, quedando libre de dichas formas la zona central inferior.  one . - AIR OCLUSIONER FOR SERUM AND / OR MEDICATION INFUSION SYSTEMS, characterized by being constituted from a preferably cylindrical body, connected by two zones, one to the area of medication infusion and / or serum provided in the machinery, and another to the dropper system by means of an appropriate connection means at each end, and which houses in its chamber a central semicircle and two placed in opposite directions whose start / end are the connection ends, the lower central area being free of such forms.
2. - OCLUSIONADOR DE AIRE PARA SISTEMAS DE INFUSIÓN DE SUERO Y/O MEDICACIÓN, según reivindicación 1 , caracterizado por que la cámara está provista de una membrana diametral deformable por presión del fluido, fijada de un extremo al otro de forma longitudinal con respecto a dicha cámara, hallándose en la zona inferior central una perforación.  2. - AIR OCLUSIONER FOR SERUM INFUSION SYSTEMS AND / OR MEDICATION, according to claim 1, characterized in that the chamber is provided with a diametral membrane deformable by fluid pressure, fixed from one end to the other longitudinally with respect to said chamber, a perforation being found in the lower central area.
PCT/ES2014/070987 2014-01-03 2014-12-29 Air-occlusion device for drip systems for administering serum and/or medication WO2015101690A1 (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5660205A (en) * 1994-12-15 1997-08-26 Epstein; Alan B. One-way valve
ES2270994T3 (en) * 2000-02-28 2007-04-16 Sherwood Services Ag VALVE AGAINST THE FREE FLOW DEPENDENT ON THE TUBE.
WO2009031018A2 (en) * 2007-09-05 2009-03-12 Haemotronic Advanced Medical Technologies S.P.A. Check valve for a medical device
US20130116653A1 (en) * 2010-06-04 2013-05-09 Ian Guy Intravenous infusion device with drip chamber and elastic float

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5660205A (en) * 1994-12-15 1997-08-26 Epstein; Alan B. One-way valve
ES2270994T3 (en) * 2000-02-28 2007-04-16 Sherwood Services Ag VALVE AGAINST THE FREE FLOW DEPENDENT ON THE TUBE.
WO2009031018A2 (en) * 2007-09-05 2009-03-12 Haemotronic Advanced Medical Technologies S.P.A. Check valve for a medical device
US20130116653A1 (en) * 2010-06-04 2013-05-09 Ian Guy Intravenous infusion device with drip chamber and elastic float

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