WO2019170945A1 - Pre-labelled element for the administration of medicinal substances - Google Patents
Pre-labelled element for the administration of medicinal substances Download PDFInfo
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- WO2019170945A1 WO2019170945A1 PCT/ES2019/070127 ES2019070127W WO2019170945A1 WO 2019170945 A1 WO2019170945 A1 WO 2019170945A1 ES 2019070127 W ES2019070127 W ES 2019070127W WO 2019170945 A1 WO2019170945 A1 WO 2019170945A1
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- administration
- identified element
- color
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
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- 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
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65C—LABELLING OR TAGGING MACHINES, APPARATUS, OR PROCESSES
- B65C3/00—Labelling other than flat surfaces
- B65C3/02—Affixing labels to elongated objects, e.g. wires, cables, bars, tubes
Definitions
- the present invention belongs to the field of medical devices for administering drug substances.
- the device of the invention refers to a pre-identified element comprising an administration element, intended to administer liquid or fluid medicament substances to a patient, for example, by infusion, infusion, drip or injection, in the that a label, adhesive, a color, label, alphanumeric characters, symbols, codes, reliefs, images or any other characteristic that the element carries is identifying the route of administration to which said element should be applied.
- the identification protocol developed by the Ministry of Health of the Community of Madrid also contemplates identifying the different routes of administration, with a series of standardized legends. More particularly, said identification protocol of the Ministry of Health of the Community of Madrid uses the following legends and background colors:
- identification labels of predetermined colors have begun to be marketed, which conform to the criteria of the identification protocol of the Community of Madrid.
- Said labels have adhesive on at least one of their faces and are rolled into elongated protective strips, forming rolls. The rolls are introduced, in turn, inside dispensers, which facilitate the removal of the labels.
- dispensers which facilitate the removal of the labels.
- an element for administering drug substances to a patient is placed, said element must be subsequently identified with the corresponding label.
- the form of administration is, for example, of the central intravenous type
- the healthcare personnel must choose a blue label (Pantone code 2945C), remove it from the corresponding dispenser and paste it on the element. of administration to identify it.
- the procedure for removing the identification labels of the dispensers is sometimes difficult to perform especially, for example, if the medical personnel wear gloves, which is common due to prophylaxis.
- identifying labels are broken when removed, they are attached to the gloves of the healthcare professional and / or the ends of said labels are glued together, being rendered useless. This also translates into an increase in the consumption of these identifying labels, with the consequent economic and time expenditure.
- administration element refers interchangeably, both to the routes of administration of drug substances, and to the lines of administration of substances.
- route of administration of medicament substances designates any device for administration of medicament substances intended to be introduced - totally or partially - into a blood duct, blood vessel, organ or cavity of a patient.
- drug administration routes are, therefore, catheters, cannulas, and needles.
- drug substance administration line refers to any device for administering drug substances that is not intended to be introduced into a patient's bloodstream, blood vessel, organ or cavity, but to transport the medicinal substances from a reservoir (bag or container) that contains it and already coupled to a route to introduce said medicament substance into the body of a patient.
- drug substance administration lines are, therefore, lights, lumens, extensions, probes, connectors, infusion equipment and infusion equipment.
- distal end of an administration element is that closest to the patient, while the “proximal end” of an administration element is that furthest from said patient.
- patient designates a human or animal being, to whom a drug substance is administered.
- fusion refers to the administration of a drug substance by injection into the patient's circulatory system.
- perfusion refers -in the present specification- to the administration of a drug substance by introducing it, gradually, continuously and / or intermittently into the circulatory or lymphatic system of a patient, by for example, by gravity drip from a perforated bag and coupled to the administration element.
- pre-identified element means that said element has been previously identified, at some stage of its manufacturing or obtaining process, including packaging or packaging thereof. That is to say, the element supplied, according to the invention, to be used by the sanitary personnel, already carries the factory labels and / or inside the package, where appropriate, or will be determined by colors, labels, text, acronyms, reliefs, image, code, silkscreen, adhesive or any other feature that helps to recognize and make the application of the element. Not being necessary by the staff that will use it, identify it before use when it comes already pre-identified.
- the adjective "medicated” is used to designate -in this specification- any fluid substance, preferably liquid, used in the treatment or prevention of diseases.
- They are medicinal substances, for example and without limitation, injectable drugs, anesthetic or sedative substances, blood, plasma, blood products, saline solutions and serums, as well as food substances, nutrients and vitamin complexes supplied to a patient. , for example, by a nasogastric tube.
- the present invention is intended to address the problems and disadvantages of the prior art indicated above, providing a pre-identified element of administration of drug substances; characterized in that said element is provided with one or more identifying characteristics, which ensure the specific form of administration of the drug substances through said element, from among a set of possible forms of administration.
- the administration elements according to the present invention are therefore pre-identified. In this way, the risk of error in administration is limited and the need to affix labels to the elements is eliminated, once said elements have been prepared for administration to a patient, in order to identify what the specific form is of administration of drug substances through each of them (central intravenous, peripheral intravenous, subcutaneous, epidural, intrathecal / intradural, intraarterial, oral / enteral, etc.).
- the modalities pre-identify the administration form of the drug substances, according to a standardized identification protocol.
- the modalities pre-identify the administration form of the drug substances, according to a standardized identification protocol, which associates a specific color with each possible administration form.
- the methods of pre-identification of use in the present invention may have a predetermined color, depending on the specific form of administration, as provided by the Identification Protocol of the Ministry of Health of the Community of Madrid .
- the pre-identification modalities in addition to being of a predetermined color - which varies depending on the specific form of administration - also contain a legend that describes what said form of administration is in one or more item locations.
- the standardized identification protocol associates with the "central intravenous” administration the color blue, the "peripheral intravenous” the light blue color, the “subcutaneous” the light orange color, a the “epidural” the yellow color, the “intrathecal / intradural” the yellow color, the “intra-arterial” the red color, and the “oral / enteral” the purple / violet color.
- the administration element is provided with a first identification, arranged in its proximal region and a second identification, arranged in its distal region.
- the pre-identified element according to the invention is a route of administration of medicament substances.
- the pre-identified administration element according to the invention is a drug substance administration line.
- the pre-identified drug substance administration element is contained in a packaging wrapper, preferably, bag or blister type.
- the pre-identified drug substance administration element is also pre-packaged or pre-packaged.
- the pre-identified element of administration of pre-packaged or pre-packaged drug substances, as a whole, is sterilized.
- Figures 1A, 1 B, 1 C, 1 D, 1 E, 1 F and 1G are schematic views of a first pre-identified element, in accordance with the present invention, in the form of a drug substance delivery line.
- An example of a pre-identified element provided with the packaging wrap is shown in Fig. 1A, while in Fig. 1 B, 1 C, 1 D, 1 E, 1 F and 1G, said packaging wrappers have been removed, in order to be able to better appreciate the rest of the components of the pre-identified drug administration element according to the invention.
- Fig. 2A is a schematic view of a second example of a pre-identified element, in accordance with the present invention, in the form of a drug delivery route, provided with a blister packaging package.
- Figures 1A, 1 B, 1 C, 1 D, 1 E, 1 F and 1 G show pre-identified elements for administering drug substances according to the invention, which is - in this embodiment of the invention - a line ( 20) administration of medicinal substances.
- Said line (20) is arranged inside a wrapper (10) of bag-type packaging.
- the proximal area of the line (20) is provided with a first identifying tag (30), while the distal area of the line (20) is provided with a second identifying tag (35) .
- Each of the labels (30) and (35) is formed, in this specific embodiment of the invention, by two symmetrical parts 40 mm in length, joined by a 20 mm length and 10 mm width.
- the obverse of the labels (30) and (35) is formed by a light blue material (Pantone code 297C) which is, according to the Identification Protocol of the Ministry of Health of the Community of Madrid, the corresponding color to a peripheral intravenous administration line. Also, the back of labels (30) and (35) is provided with an adhesive, which allows its adhesion to line 20.
- a light blue material Pantone code 297C
- each of said labels (30) and (35) embraces line 20, the two parts that compose them being arranged as a flag.
- a legend (40) is provided that specifies that the form of administration is, in this particular case, peripheral intravenous.
- a legend (45) is provided that specifies that the form of administration is, in this case, peripheral intravenous.
- Legends (40) and (45) use an 8-point straight Arial font.
- the pre-identification is given by colors (50) and (50 ' ), adhesives, symbols or specific codes (60) and (60 ' ) in the different fluid management elements: the dropper, the system, the three-step key and the extension.
- FIG. 2A Another embodiment of the invention is shown in Figure 2A in which the pre-identified element of administration of drug substances is a route (20 ' ) of administration of drug substances.
- the obverse of the label (35) is formed by a light orange material (Pantone code 164C) which is, according to the Identification Protocol of the Ministry of Health of the Community of Madrid, the corresponding color to a subcutaneous route of administration.
- the label (35) is also provided with a legend (45) that specifies that the form of administration is, in this particular case, subcutaneous.
- the track (20 ' ) is arranged inside a blister-type packaging (10 ' ).
- FIG. 2B Another specific embodiment of the invention is shown in Figure 2B in which the pre-identification is given by colors (50) and (50 ' ), codes or symbols (60) specific to the different fluid and catheter administration elements.
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Abstract
The invention relates to pre-labelled element for the administration of medicinal substances, characterised in that it is provided with one or more identifying tags. The element can be a route, such as a cannula, or a line, such as a lumen or a probe.
Description
DESCRIPCIÓN DESCRIPTION
Elemento pre-identificado de administración de sustancias medicamentosas. Pre-identified element of administration of medicinal substances.
OBJETO DE LA INVENCIÓN OBJECT OF THE INVENTION
La presente invención pertenece al campo de los dispositivos médicos de administración de sustancias medicamentosas. The present invention belongs to the field of medical devices for administering drug substances.
Más en particular, el dispositivo de la invención se refiere a un elemento pre-identificado que comprende un elemento de administración, destinado a administrar sustancias medicamentosas líquidas o fluidas a un paciente, por ejemplo, por infusión, perfusión, goteo o inyección, en el que una etiqueta, adhesivo, un color, rótulo, caracteres alfanuméricos, símbolos, códigos, relieves, imágenes o cualquier otra característica que porte el elemento es identificativo de la vía de administración al que debe aplicarse dicho elemento. More in particular, the device of the invention refers to a pre-identified element comprising an administration element, intended to administer liquid or fluid medicament substances to a patient, for example, by infusion, infusion, drip or injection, in the that a label, adhesive, a color, label, alphanumeric characters, symbols, codes, reliefs, images or any other characteristic that the element carries is identifying the route of administration to which said element should be applied.
ANTECEDENTES DE LA INVENCIÓN BACKGROUND OF THE INVENTION
La administración de sustancias medicamentosas a un paciente es una de las técnicas empleadas más habitualmente en la práctica clínica, especialmente en la práctica hospitalaria. The administration of medicinal substances to a patient is one of the techniques most commonly used in clinical practice, especially in hospital practice.
No obstante, en ocasiones se producen errores de administración, causados frecuentemente por una deficiente identificación de los elementos a través de los cuales se deben administrar las sustancias medicamentosas. However, administration errors sometimes occur, often caused by poor identification of the elements through which the drug substances should be administered.
Dichos errores suponen un riesgo para la salud de los pacientes. Asimismo, generan, desconfianza en los servicios sanitarios y provocan sobrecostes importantes. These errors pose a risk to the health of patients. They also generate, distrust in health services and cause significant extra costs.
En vista de ello, distintas autoridades sanitarias han dictado recientemente una serie de directrices, que obligan a los profesionales sanitarios a identificar, de acuerdo con un protocolo normalizado, los diferentes elementos de administración de sustancias medicamentosas aplicados a un paciente en función de la zona del cuerpo humano a través de la cual debe administrarse dicha sustancia medicamentosa. i
Así, por ejemplo, la Consejería de Sanidad de la Comunidad de Madrid (entidad pública sanitaria española de carácter regional) ha desarrollado un protocolo de identificación de formas de administración de sustancias medicamentosas, que contempla identificar cada uno de los elementos de administración con una etiqueta de un color predeterminado, que varía en función de la forma de concreta administración: intravenosa central, intravenosa periférica, subcutánea, epidural, intratecal/intradural, intraarterial, oral, enteral, inhalatoria, etc. Cada uno de dichos colores se define mediante un código del sistema Pantone ®, un sistema de definición cromática desarrollado por la empresa Pantone Inc. In view of this, different health authorities have recently issued a series of guidelines, which require health professionals to identify, according to a standardized protocol, the different elements of administration of drug substances applied to a patient depending on the area of the human body through which said drug substance should be administered. i Thus, for example, the Ministry of Health of the Community of Madrid (Spanish public health entity of a regional nature) has developed a protocol for the identification of forms of administration of drug substances, which includes identifying each of the administration elements with a label of a predetermined color, which varies depending on the form of concrete administration: intravenous central, intravenous peripheral, subcutaneous, epidural, intrathecal / intradural, intraarterial, oral, enteral, inhalatory, etc. Each of these colors is defined by a Pantone ® system code, a color definition system developed by Pantone Inc.
El protocolo de identificación desarrollado por la Consejería de Sanidad de la Comunidad de Madrid también contempla identificar las diferentes vías de administración, con una serie de leyendas normalizadas. Más en particular, dicho protocolo de identificación de la Consejería de Sanidad de la Comunidad de Madrid emplea las siguientes leyendas y colores de fondo: The identification protocol developed by the Ministry of Health of the Community of Madrid also contemplates identifying the different routes of administration, with a series of standardized legends. More particularly, said identification protocol of the Ministry of Health of the Community of Madrid uses the following legends and background colors:
Recientemente han empezado a comercializarse etiquetas identificativas de colores predeterminados, que se ajustan a los criterios del protocolo de identificación de la Comunidad de Madrid. Dichas etiquetas tienen adhesivo en, al menos, una de sus caras y se enrollan en tiras protectoras alargadas, formando rollos. Los rollos se introducen, a su vez, en el interior de dispensadores, que facilitan la extracción de las etiquetas.
De este modo, cuando se coloca un elemento de administración de sustancias medicamentosas a un paciente, dicho elemento deberá identificarse posteriormente con la etiqueta correspondiente. Así, si la forma de administración es, por ejemplo, de tipo intravenosa central, una vez colocado el elemento de administración en el paciente, el personal sanitario deberá elegir una etiqueta azul (código Pantone 2945C), extraerla del dispensador correspondiente y pegarla sobre elemento de administración para identificarlo. Recently, identification labels of predetermined colors have begun to be marketed, which conform to the criteria of the identification protocol of the Community of Madrid. Said labels have adhesive on at least one of their faces and are rolled into elongated protective strips, forming rolls. The rolls are introduced, in turn, inside dispensers, which facilitate the removal of the labels. Thus, when an element for administering drug substances to a patient is placed, said element must be subsequently identified with the corresponding label. Thus, if the form of administration is, for example, of the central intravenous type, once the administration element has been placed on the patient, the healthcare personnel must choose a blue label (Pantone code 2945C), remove it from the corresponding dispenser and paste it on the element. of administration to identify it.
En algunos casos es necesario identificar, tanto el extremo distal, como el extremo proximal del elemento de administración, lo que implica pegar dos etiquetas a cada elemento de administración colocado al paciente. Este proceso de colocación de etiquetas identificativas puede resultar, en algunos casos, tedioso y complicado, para el personal sanitario y conlleva cierto riesgo de error. In some cases, it is necessary to identify both the distal end and the proximal end of the administration element, which implies attaching two labels to each administration element placed on the patient. This process of placing identification tags can be, in some cases, tedious and complicated, for healthcare personnel and carries a certain risk of error.
Asimismo, el procedimiento de extracción de las etiquetas identificativas de los dispensadores es, en ocasiones, difícil de realizar especialmente, por ejemplo, si el personal sanitario emplea guantes, lo que es habitual por cuestiones de profilaxis. Likewise, the procedure for removing the identification labels of the dispensers is sometimes difficult to perform especially, for example, if the medical personnel wear gloves, which is common due to prophylaxis.
De hecho, algunas de las etiquetas identificativas se rompen al extraerlas, se pegan a los guantes del profesional sanitario y/o los extremos de dichas etiquetas se pegan entre sí, quedando inutilizadas. Esto también se traduce en un aumento del consumo de dichas etiquetas identificativas, con el consiguiente gasto económico y de tiempo. In fact, some of the identifying labels are broken when removed, they are attached to the gloves of the healthcare professional and / or the ends of said labels are glued together, being rendered useless. This also translates into an increase in the consumption of these identifying labels, with the consequent economic and time expenditure.
En algunos casos, tras haber colocado las etiquetas identificativas es necesario, además, escribir en ellas las leyendas correspondientes a la forma de administración de la que se trate, de acuerdo con el protocolo de identificación, lo que alarga el procedimiento, implica el uso de material de escritura, como por ejemplo rotuladores, con la consiguiente complejidad y falta de higiene al emplear material no estéril. In some cases, after having placed the identification tags, it is also necessary to write in them the legends corresponding to the administration method in question, according to the identification protocol, which lengthens the procedure, implies the use of writing material, such as markers, with the consequent complexity and lack of hygiene when using non-sterile material.
Es, por lo tanto, conveniente abordar todas las desventajas de la técnica anterior, arriba descritas y proporcionar una solución técnica a este problema técnico objetivo que suponga una ventaja para el personal sanitario especializado, especialmente en el área de enfermería, a la hora de abordar la administración de sustancias medicamentosas líquidas o fluidas por la vía de administración adecuada, evitando errores y los problemas en el manejo de etiquetas, arriba mencionados.
DEFINICIONES It is, therefore, convenient to address all the disadvantages of the prior art, described above and provide a technical solution to this objective technical problem that is an advantage for specialized health personnel, especially in the area of nursing, when addressing the administration of liquid or fluid drug substances by the appropriate route of administration, avoiding errors and problems in handling labels, mentioned above. DEFINITIONS
A lo largo de la presente memoria descriptiva debe entenderse que el término“elemento de administración” se refiere indistintamente, tanto a las vías de administración de sustancias medicamentosas, como a las líneas de administración de sustancias. Throughout the present specification it should be understood that the term "administration element" refers interchangeably, both to the routes of administration of drug substances, and to the lines of administration of substances.
En la presente memoria descriptiva, la expresión “vía de administración de sustancias medicamentosas” designa a todo aquel dispositivo de administración de sustancias medicamentosas destinado a introducirse -total o parcialmente- en un conducto sanguíneo, vaso sanguíneo, órgano o cavidad de un paciente. Ejemplos de vías de administración de sustancias medicamentosas son, por tanto, los catéteres, cánulas, y agujas. In the present specification, the term "route of administration of medicament substances" designates any device for administration of medicament substances intended to be introduced - totally or partially - into a blood duct, blood vessel, organ or cavity of a patient. Examples of drug administration routes are, therefore, catheters, cannulas, and needles.
En la presente memoria descriptiva, la expresión “línea de administración de sustancias medicamentosas” designa a todo aquel dispositivo de administración de sustancias medicamentosas que no está destinado a introducirse en un conducto sanguíneo, vaso sanguíneo, órgano o cavidad de un paciente, sino a transportar las sustancias medicamentosas desde un reservorio (bolsa o envase) que lo contiene y a acoplarse a una vía para introducir dicha sustancia medicamentosa en el interior del cuerpo de un paciente. Ejemplos de líneas de administración de sustancias medicamentosas son, por tanto, las luces, lúmenes, alargaderas, sondas, conectores, equipos de perfusión y equipos de infusión. In the present specification, the term "drug substance administration line" refers to any device for administering drug substances that is not intended to be introduced into a patient's bloodstream, blood vessel, organ or cavity, but to transport the medicinal substances from a reservoir (bag or container) that contains it and already coupled to a route to introduce said medicament substance into the body of a patient. Examples of drug substance administration lines are, therefore, lights, lumens, extensions, probes, connectors, infusion equipment and infusion equipment.
Asimismo, debe entenderse que el“extremo distal”, de un elemento de administración es aquél más próximo al paciente, mientras que el “extremo proximal” de un elemento de administración es aquel más alejado de dicho paciente. Likewise, it should be understood that the "distal end" of an administration element is that closest to the patient, while the "proximal end" of an administration element is that furthest from said patient.
También debe entenderse que el término“paciente” designa a un ser humano o animal, al que se le administra una sustancia medicamentosa. It should also be understood that the term "patient" designates a human or animal being, to whom a drug substance is administered.
A lo largo de la presente memoria descriptiva, el término “infusión” se refiere a la administración de una sustancia medicamentosa por inyección en el sistema circulatorio del paciente. Throughout the present specification, the term "infusion" refers to the administration of a drug substance by injection into the patient's circulatory system.
Asimismo, debe entenderse que el término“perfusión” se refiere -en la presente memoria descriptiva- a la administración de una sustancia medicamentosa introduciéndola, de forma paulatina, continuada y/o intermitente en el sistema circulatorio o linfático de un paciente, por
ejemplo, por goteo por gravedad a partir de una bolsa perforada y acoplada al elemento de administración. Likewise, it should be understood that the term "perfusion" refers -in the present specification- to the administration of a drug substance by introducing it, gradually, continuously and / or intermittently into the circulatory or lymphatic system of a patient, by for example, by gravity drip from a perforated bag and coupled to the administration element.
En la presente memoria descriptiva, la expresión“elemento pre-identificado” quiere decir que dicho elemento ha sido identificado previamente, en alguna etapa de su proceso de fabricación u obtención, incluyendo el empaquetamiento o envasado del mismo. Es decir, el elemento suministrado, según la invención, para ser empleado por el personal sanitario, porta ya las etiquetas de fábrica y/o dentro del envase, en su caso, o estará determinado mediante colores, rótulos, texto, siglas, relieves, imagen, código, serigrafía, adhesivo o cualquier otra característica que ayude a reconocer y realizar la aplicación del elemento. No siendo necesario por parte del personal que va a utilizarlo, identificarlo previamente a su uso al venir el mismo ya pre-identificado. In the present specification, the expression "pre-identified element" means that said element has been previously identified, at some stage of its manufacturing or obtaining process, including packaging or packaging thereof. That is to say, the element supplied, according to the invention, to be used by the sanitary personnel, already carries the factory labels and / or inside the package, where appropriate, or will be determined by colors, labels, text, acronyms, reliefs, image, code, silkscreen, adhesive or any other feature that helps to recognize and make the application of the element. Not being necessary by the staff that will use it, identify it before use when it comes already pre-identified.
Por último, debe entenderse que el adjetivo“medicamentoso” se utiliza para designar -en la presente memoria descriptiva- a cualquier sustancia fluida, preferiblemente líquida, utilizada en el tratamiento o prevención de enfermedades. Son sustancias medicamentosas, por ejemplo y sin carácter limitativo, los fármacos inyectables, las sustancias anestésicas o sedantes, la sangre, el plasma, los hemoderivados, las soluciones salinas y sueros, así como las sustancias alimenticias, nutrientes y complejos vitamínicos suministrados a un paciente, por ejemplo, mediante una sonda nasogástrica. Finally, it should be understood that the adjective "medicated" is used to designate -in this specification- any fluid substance, preferably liquid, used in the treatment or prevention of diseases. They are medicinal substances, for example and without limitation, injectable drugs, anesthetic or sedative substances, blood, plasma, blood products, saline solutions and serums, as well as food substances, nutrients and vitamin complexes supplied to a patient. , for example, by a nasogastric tube.
DESCRIPCIÓN DE LA INVENCIÓN DESCRIPTION OF THE INVENTION
La presente invención, pretende abordar los problemas y desventajas de la técnica anterior arriba indicados, proporcionando un -elemento pre-identificado de administración de sustancias medicamentosas; caracterizado porque dicho elemento está provisto de una o más características identificativas, que aseguran cuál es la forma específica de administración de las sustancias medicamentosas a través de dicho elemento, de entre un conjunto de posibles formas de administración. The present invention is intended to address the problems and disadvantages of the prior art indicated above, providing a pre-identified element of administration of drug substances; characterized in that said element is provided with one or more identifying characteristics, which ensure the specific form of administration of the drug substances through said element, from among a set of possible forms of administration.
Los elementos de administración según la presente invención vienen, por lo tanto, pre identificados. De esta forma, se limita el riesgo de error en la administración y se elimina la necesidad de pegar etiquetas a los elementos, una vez que dichos elementos se han preparado para la administración a un paciente, con el fin de identificar cuál es la forma específica de administración de las sustancias medicamentosas a través de cada uno de ellos
(intravenosa central, intravenosa periférica, subcutánea, epidural, intratecal/intradural, intraarterial, oral/enteral, etc.). The administration elements according to the present invention are therefore pre-identified. In this way, the risk of error in administration is limited and the need to affix labels to the elements is eliminated, once said elements have been prepared for administration to a patient, in order to identify what the specific form is of administration of drug substances through each of them (central intravenous, peripheral intravenous, subcutaneous, epidural, intrathecal / intradural, intraarterial, oral / enteral, etc.).
Asimismo, se evita el riesgo de que las etiquetas identificativas se rompan al extraerlas, se peguen a los guantes del personal sanitario o queden inutilizadas al pegarse, por error, los bordes de dichas etiquetas entre sí. Se optimiza el consumo de tiempo y de material. It also avoids the risk that the identification tags break when removed, stick to the gloves of the medical staff or become unusable by sticking, by mistake, the edges of these labels with each other. Time and material consumption is optimized.
En una realización preferida de la invención, las modalidades pre-identifican la forma de administración de las sustancias medicamentosas, según un protocolo normalizado de identificación. In a preferred embodiment of the invention, the modalities pre-identify the administration form of the drug substances, according to a standardized identification protocol.
En una realización aún más preferida de la invención, las modalidades pre-identifican la forma de administración de las sustancias medicamentosas, según un protocolo normalizado de identificación, que asocia un color específico a cada posible forma de administración. In an even more preferred embodiment of the invention, the modalities pre-identify the administration form of the drug substances, according to a standardized identification protocol, which associates a specific color with each possible administration form.
Así, por ejemplo, las modalidades de pre-identificación de uso en la presente invención pueden tener un color predeterminado, en función de la forma específica de administración, según lo dispuesto por el Protocolo de Identificación de la Consejería de Sanidad de la Comunidad de Madrid. Thus, for example, the methods of pre-identification of use in the present invention may have a predetermined color, depending on the specific form of administration, as provided by the Identification Protocol of the Ministry of Health of the Community of Madrid .
En una realización todavía más preferida de la invención las modalidades de pre identificación, además de ser de un color predeterminado -que varía en función de la forma concreta de administración- también contienen una leyenda que describe cuál es dicha forma de administración en uno o varios lugares del elemento. In an even more preferred embodiment of the invention, the pre-identification modalities, in addition to being of a predetermined color - which varies depending on the specific form of administration - also contain a legend that describes what said form of administration is in one or more item locations.
En la realización más preferida de la invención, el protocolo normalizado de identificación asocia a la forma de administración “intravenosa central” el color azul, a la“intravenosa periférica” el color azul claro, a la“subcutánea” el color naranja claro, a la“epidural” el color amarillo, a la“intratecal/intradural” el color amarillo, a la“intraarterial” el color rojo, y a la “oral/enteral” el color morado/violeta. In the most preferred embodiment of the invention, the standardized identification protocol associates with the "central intravenous" administration the color blue, the "peripheral intravenous" the light blue color, the "subcutaneous" the light orange color, a the "epidural" the yellow color, the "intrathecal / intradural" the yellow color, the "intra-arterial" the red color, and the "oral / enteral" the purple / violet color.
En otra realización preferida de la invención, el elemento de administración está provisto de una primera identificación, dispuesta en su región proximal y una segunda identificación, dispuesta en su región distal.
En una realización de la invención, el elemento pre-identificado según la invención, es una vía de administración de sustancias medicamentosas. In another preferred embodiment of the invention, the administration element is provided with a first identification, arranged in its proximal region and a second identification, arranged in its distal region. In an embodiment of the invention, the pre-identified element according to the invention is a route of administration of medicament substances.
En otra realización de la invención, el elemento de administración pre-identificado según la invención, es una línea de administración de sustancias medicamentosas. In another embodiment of the invention, the pre-identified administration element according to the invention is a drug substance administration line.
En otra realización de la invención, el elemento pre-identificado de administración de sustancias medicamentosas está contenido en un envoltorio de empaquetado, preferiblemente, tipo bolsa o blíster. In another embodiment of the invention, the pre-identified drug substance administration element is contained in a packaging wrapper, preferably, bag or blister type.
En otra realización de la invención, el elemento pre-identificado de administración de sustancias medicamentosas está también pre-empaquetado o pre-envasado. En una realización alternativa de la invención, el elemento pre-identificado de administración de sustancias medicamentosas pre-empaquetado o pre-envasado, en conjunto, está esterilizado. In another embodiment of the invention, the pre-identified drug substance administration element is also pre-packaged or pre-packaged. In an alternative embodiment of the invention, the pre-identified element of administration of pre-packaged or pre-packaged drug substances, as a whole, is sterilized.
BREVE DESCRIPCIÓN DE LAS FIGURAS BRIEF DESCRIPTION OF THE FIGURES
Se explicarán ahora características adicionales de la invención con relación a las Figuras adjuntas, que se dan solamente a modo de ejemplo explicativo y no limitativo. Additional features of the invention will now be explained in relation to the attached Figures, which are given only by way of explanatory and non-limiting example.
Las figuras 1A, 1 B, 1 C, 1 D, 1 E, 1 F y 1G son vistas esquemáticas de un primer elemento pre- identificado, de acuerdo con la presente invención, en la forma de una línea de administración de sustancias medicamentosas. En la Fig. 1A se muestra un ejemplo de elemento pre- identificado provisto del envoltorio de empaquetado, mientras que en las Fig. 1 B, 1 C, 1 D, 1 E, 1 F y 1G se han retirado dichos envoltorios de empaquetado, para poder apreciar mejor el resto de los componentes del elemento pre-identificado de administración de sustancias medicamentosas según la invención. Figures 1A, 1 B, 1 C, 1 D, 1 E, 1 F and 1G are schematic views of a first pre-identified element, in accordance with the present invention, in the form of a drug substance delivery line. An example of a pre-identified element provided with the packaging wrap is shown in Fig. 1A, while in Fig. 1 B, 1 C, 1 D, 1 E, 1 F and 1G, said packaging wrappers have been removed, in order to be able to better appreciate the rest of the components of the pre-identified drug administration element according to the invention.
La Fig. 2A es una vista esquemática de un segundo ejemplo de elemento pre-identificado, de acuerdo con la presente invención, en la forma de una vía de administración de sustancias medicamentosas, provisto de un envoltorio de empaquetado tipo blíster. Fig. 2A is a schematic view of a second example of a pre-identified element, in accordance with the present invention, in the form of a drug delivery route, provided with a blister packaging package.
En la Fig. 2B se han retirado dichos envoltorios de empaquetado, para poder apreciar mejor el resto de los componentes del elemento pre-identificado de administración de sustancias medicamentosas según la invención.
REALIZACIÓN PREFERENTE DE LA INVENCIÓN In Fig. 2B, said packaging wrappers have been removed, in order to better appreciate the rest of the components of the pre-identified drug administration element according to the invention. PREFERRED EMBODIMENT OF THE INVENTION
A continuación, se describen realizaciones concretas de la invención, dadas como ejemplos ilustrativos y no limitativos, haciendo referencia a las figuras adjuntas. En dichas figuras, los componentes con funciones iguales se han designado usando el mismo número de referencia. In the following, specific embodiments of the invention are described, given as illustrative and non-limiting examples, with reference to the attached figures. In said figures, components with equal functions have been designated using the same reference number.
En las Figuras 1A, 1 B, 1 C, 1 D, 1 E, 1 F y 1 G se muestran elementos pre-identificados de administración de sustancias medicamentosas según la invención, que es -en esta realización de la invención- una línea (20) de administración de sustancias medicamentosas. Dicha línea (20) está dispuesta en el interior de un envoltorio (10) de empaquetado tipo bolsa. Figures 1A, 1 B, 1 C, 1 D, 1 E, 1 F and 1 G show pre-identified elements for administering drug substances according to the invention, which is - in this embodiment of the invention - a line ( 20) administration of medicinal substances. Said line (20) is arranged inside a wrapper (10) of bag-type packaging.
En esta primera realización específica de la invención, el área proximal de la línea (20) está provista de una primera etiqueta identificativa (30), mientras que el área distal de la línea (20) está provista de una segunda etiqueta identificativa (35). In this first specific embodiment of the invention, the proximal area of the line (20) is provided with a first identifying tag (30), while the distal area of the line (20) is provided with a second identifying tag (35) .
Cada una de las etiquetas (30) y (35) está formada, en esta realización específica de la invención, por dos partes simétricas de 40 mm de longitud, unidas por un itsmo de 20 mm de longitud y 10 mm de anchura. Each of the labels (30) and (35) is formed, in this specific embodiment of the invention, by two symmetrical parts 40 mm in length, joined by a 20 mm length and 10 mm width.
El anverso de las etiquetas (30) y (35) está formado por un material de color azul claro (código de Pantone 297C) que es, según el Protocolo de Identificación de la Consejería de Sanidad de la Comunidad de Madrid, el color que corresponde a una línea de administración de tipo intravenoso periférico. Asimismo, el reverso de las etiquetas (30) y (35) está provisto de un adhesivo, que permite su adhesión a línea 20. The obverse of the labels (30) and (35) is formed by a light blue material (Pantone code 297C) which is, according to the Identification Protocol of the Ministry of Health of the Community of Madrid, the corresponding color to a peripheral intravenous administration line. Also, the back of labels (30) and (35) is provided with an adhesive, which allows its adhesion to line 20.
En esta forma de realización particular de la invención, cada una de dichas etiquetas (30) y (35) abraza la línea 20, quedando las dos partes que las componen, dispuestas a modo de bandera. In this particular embodiment of the invention, each of said labels (30) and (35) embraces line 20, the two parts that compose them being arranged as a flag.
En el anverso de la etiqueta (30) está provista una leyenda (40) que especifica que la forma de administración es, en este caso concreto, intravenosa periférica. Asimismo, en el anverso de la etiqueta (35) está provista una leyenda (45) que especifica que la forma de administración es, en este caso, intravenosa periférica. Las leyendas (40) y (45) utilizan una fuente recta tipo Arial de 8 puntos.
En posteriores ejemplos de realizaciones específicas, la pre-identificación viene dada por colores (50) y (50'), adhesivos, símbolos o códigos específicos (60) y (60') en los diferentes elementos de administración de fluidos: el gotero, el sistema, la llave de tres pasos y la alargadera. On the obverse of the label (30) a legend (40) is provided that specifies that the form of administration is, in this particular case, peripheral intravenous. Also, on the obverse of the label (35) a legend (45) is provided that specifies that the form of administration is, in this case, peripheral intravenous. Legends (40) and (45) use an 8-point straight Arial font. In subsequent examples of specific embodiments, the pre-identification is given by colors (50) and (50 ' ), adhesives, symbols or specific codes (60) and (60 ' ) in the different fluid management elements: the dropper, the system, the three-step key and the extension.
En la Figura 2A se muestra otra realización de la invención en la que el elemento pre identificado de administración de sustancias medicamentosas es una vía (20') de administración sustancias medicamentosas. En esta realización, el anverso de la etiqueta (35) está formado por un material de color naranja claro (código de Pantone 164C) que es, según el Protocolo de Identificación de la Consejería de Sanidad de la Comunidad de Madrid, el color que corresponde a una vía de administración de tipo subcutáneo. La etiqueta (35) está provista, además, de una leyenda (45) que especifica que la forma de administración es, en este caso concreto, subcutánea. Asimismo, la vía (20') está dispuesta en el interior de un envoltorio (10') de empaquetado tipo blíster. Another embodiment of the invention is shown in Figure 2A in which the pre-identified element of administration of drug substances is a route (20 ' ) of administration of drug substances. In this embodiment, the obverse of the label (35) is formed by a light orange material (Pantone code 164C) which is, according to the Identification Protocol of the Ministry of Health of the Community of Madrid, the corresponding color to a subcutaneous route of administration. The label (35) is also provided with a legend (45) that specifies that the form of administration is, in this particular case, subcutaneous. Also, the track (20 ' ) is arranged inside a blister-type packaging (10 ' ).
En la Figura 2B se muestra otra realización específica de la invención en la que la pre identificación viene dada por colores (50) y (50'), códigos o símbolos (60) específicos en los diferentes elementos de administración de fluidos y catéteres. Another specific embodiment of the invention is shown in Figure 2B in which the pre-identification is given by colors (50) and (50 ' ), codes or symbols (60) specific to the different fluid and catheter administration elements.
Aunque la invención se ha descrito únicamente con relación a las realizaciones a la que se hace mención en la presente, debe entenderse que otras posibles combinaciones, variaciones y mejoras, también estarían incluidas dentro del alcance de protección de la invención, el cual está definido exclusivamente por las reivindicaciones adjuntas. Although the invention has been described only in relation to the embodiments referred to herein, it should be understood that other possible combinations, variations and improvements, would also be included within the scope of protection of the invention, which is defined exclusively by the appended claims.
LISTADO DE REFERENCIAS NUMÉRICAS EMPLEADAS EN LAS FIGURAS LIST OF NUMERICAL REFERENCES USED IN THE FIGURES
(10): Envoltorio de empaquetado tipo bolsa; (10): Bag-type packaging wrap;
(10'): Envoltorio de empaquetado tipo blíster; (10 ' ): Blister packaging packaging;
(20): Línea de administración de sustancias medicamentosas; (20): Drug substance administration line;
(20'): Vía de administración de sustancias medicamentosas; (20 ' ): Route of administration of medicinal substances;
(30): Etiqueta proximal; (30): Proximal tag;
(35): Etiqueta distal; (35): Distal label;
(40, 45) Leyendas que describen la forma de administración; (40, 45) Legends that describe the form of administration;
(50, 50') Colores que identifican los distintos elementos; (50, 50 ' ) Colors that identify the different elements;
(60, 60') Símbolos o códigos que identifican los distintos elementos.
(60, 60 ' ) Symbols or codes that identify the different elements.
Claims
1. Elemento pre-identificado (20, 20') de administración de sustancias medicamentosas caracterizado porque está provisto de una o más etiquetas identificativas (30, 35), que identifican la forma específica de administración de las sustancias medicamentosas a través de dicho elemento (20, 20'), de entre un conjunto de posibles formas de administración. 1. Pre-identified element (20, 20 ' ) of administration of medicinal substances characterized in that it is provided with one or more identifying labels (30, 35), which identify the specific form of administration of the medicinal substances through said element ( 20, 20 ' ), from among a set of possible forms of administration.
2. Elemento pre-identificado (20, 20') según la reivindicación 1 , caracterizado porque las etiquetas (30, 35) identifican la forma de administración de las sustancias medicamentosas, según un protocolo normalizado de identificación. 2. Pre-identified element (20, 20 ' ) according to claim 1, characterized in that the labels (30, 35) identify the method of administration of the drug substances, according to a standardized identification protocol.
3. Elemento pre-identificado (20, 20') según la reivindicación 2, caracterizado porque el protocolo normalizado de identificación asocia un color específico a cada posible forma de administración. 3. Pre-identified element (20, 20 ' ) according to claim 2, characterized in that the standardized identification protocol associates a specific color with each possible form of administration.
4. Elemento pre-identificado (20, 20') según la reivindicación 3, en el que las etiquetas (30, 35) contienen una leyenda (40, 45) que describe la forma específica de administración. 4. Pre-identified element (20, 20 ' ) according to claim 3, wherein the labels (30, 35) contain a legend (40, 45) describing the specific form of administration.
5. Elemento pre-identificado (20, 20') según cualquiera de las reivindicaciones 3 o 4, caracterizado porque el protocolo normalizado de identificación asocia a la forma de administración intravenosa central, el color azul; a la intravenosa periférica, el color azul claro; a la subcutánea, el color naranja claro; a la epidural, el color amarillo; a la intratecal/intradural, el color amarillo; a la intraarterial, el color rojo y a la oral/enteral el color morado/violeta. 5. Pre-identified element (20, 20 ' ) according to any of claims 3 or 4, characterized in that the standardized identification protocol associates with the central intravenous administration form, the color blue; to the peripheral intravenous, the light blue color; to the subcutaneous, the light orange color; to the epidural, the color yellow; to the intrathecal / intradural, the color yellow; to the intraarterial, the color red and to the oral / enteral the color purple / violet.
6. Elemento pre-identificado (20, 20') según cualquiera de las reivindicaciones anteriores, caracterizado porque el elemento (20, 20') de administración está provisto de una primera etiqueta identificativa (30), dispuesta en su región proximal y una segunda etiqueta identificativa (35), dispuesta en su región distal. 6. Pre-identified element (20, 20 ' ) according to any of the preceding claims, characterized in that the administration element (20, 20 ' ) is provided with a first identification tag (30), arranged in its proximal region and a second identification tag (35), arranged in its distal region.
7. Elemento pre-identificado (20, 20') según cualquiera de las reivindicaciones anteriores, caracterizado porque el elemento de administración de sustancias medicamentosas es una línea (20) de administración de sustancias medicamentosas.
7. Pre-identified element (20, 20 ' ) according to any one of the preceding claims, characterized in that the drug substance administration element is a drug substance administration line (20).
8. Elemento pre-identificado (20, 20') según cualquiera de las reivindicaciones 1 a 6, caracterizado porque el elemento de administración de sustancias medicamentosas es una vía de administración (20') de sustancias medicamentosas. 8. Pre-identified element (20, 20 ' ) according to any of claims 1 to 6, characterized in that the drug substance administration element is a route of administration (20 ' ) of drug substances.
9. Elemento pre-identificado (20, 20') según cualquiera de las reivindicaciones anteriores, caracterizado porque dicho elemento pre-identificado (20, 20') está esterilizado. 9. Pre-identified element (20, 20 ' ) according to any of the preceding claims, characterized in that said pre-identified element (20, 20 ' ) is sterilized.
10. Elemento pre-identificado (20, 20') según cualquiera de las reivindicaciones anteriores, caracterizado porque está pre-empaquetado o pre-envasado. 10. Pre-identified element (20, 20 ' ) according to any of the preceding claims, characterized in that it is pre-packaged or pre-packaged.
11. Elemento pre-identificado (20, 20') según cualquiera de las reivindicaciones anteriores, caracterizado porque el elemento pre-identificado (20, 20') está dispuesto en el interior de un envoltorio (10, 10') de empaquetado. 11. Pre-identified element (20, 20 ' ) according to any of the preceding claims, characterized in that the pre-identified element (20, 20 ' ) is disposed inside a packaging wrapper (10, 10 ' ).
12. Elemento pre-identificado (20, 20') según la reivindicación 11 , caracterizado porque el elemento pre-identificado (20, 20') está dispuesto en el interior de un envoltorio (10) de empaquetado, de tipo bolsa. 12. Pre-identified element (20, 20 ' ) according to claim 11, characterized in that the pre-identified element (20, 20 ' ) is disposed inside a packaging bag (10).
13. Elemento pre-identificado (20, 20') según la reivindicación 11 , caracterizado porque el elemento pre-identificado (20, 20') está dispuesto en el interior de un envoltorio (10) de empaquetado, de tipo blíster. 13. Pre-identified element (20, 20 ' ) according to claim 11, characterized in that the pre-identified element (20, 20 ' ) is disposed inside a packaging package (10), of blister type.
14. Elemento pre-identificado (20, 20') según cualquiera de las reivindicaciones anteriores, caracterizado porque dicho elemento pre-identificado (20, 20') está pre-empaquetado o pre-envasado y el conjunto, esterilizado. 14. Pre-identified element (20, 20 ' ) according to any of the preceding claims, characterized in that said pre-identified element (20, 20 ' ) is pre-packaged or pre-packaged and the assembly is sterilized.
15. Elemento pre-identificado (20,20') según cualquiera de las reivindicaciones anteriores, caracterizado porque dicho elemento pre-identificado (20,20') está provisto de color, adhesivo, rótulo, caracteres alfanuméricos, símbolo, código, relieve, imagen o cualquier otra característica que describe la forma específica de administración.
15. Pre-identified element (20,20 ' ) according to any of the preceding claims, characterized in that said pre-identified element (20,20 ' ) is provided with color, adhesive, label, alphanumeric characters, symbol, code, embossment, image or any other feature that describes the specific form of administration.
Priority Applications (1)
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ES202090015U ES1257216Y (en) | 2018-03-08 | 2019-03-04 | Pre-identified element of drug administration |
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ESU201830311 | 2018-03-08 | ||
ES201830311U ES1209214Y (en) | 2018-03-08 | 2018-03-08 | Pre-labeled element for the administration of medicinal substances |
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WO2019170945A1 true WO2019170945A1 (en) | 2019-09-12 |
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PCT/ES2019/070127 WO2019170945A1 (en) | 2018-03-08 | 2019-03-04 | Pre-labelled element for the administration of medicinal substances |
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WO (1) | WO2019170945A1 (en) |
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WO2013142211A1 (en) * | 2012-03-23 | 2013-09-26 | C. R. Bard, Inc. | Indicia informative of characteristics of insertable medical devices |
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2018
- 2018-03-08 ES ES201830311U patent/ES1209214Y/en not_active Expired - Fee Related
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2019
- 2019-03-04 WO PCT/ES2019/070127 patent/WO2019170945A1/en active Application Filing
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WO2013142211A1 (en) * | 2012-03-23 | 2013-09-26 | C. R. Bard, Inc. | Indicia informative of characteristics of insertable medical devices |
Also Published As
Publication number | Publication date |
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ES1257216Y (en) | 2021-02-17 |
ES1209214Y (en) | 2018-07-03 |
ES1209214U (en) | 2018-04-09 |
ES1257216U (en) | 2020-11-27 |
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