WO2022171919A1 - Antibacterial and virucidal interface for non-invasive mechanical ventilation - Google Patents

Antibacterial and virucidal interface for non-invasive mechanical ventilation Download PDF

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Publication number
WO2022171919A1
WO2022171919A1 PCT/ES2022/070063 ES2022070063W WO2022171919A1 WO 2022171919 A1 WO2022171919 A1 WO 2022171919A1 ES 2022070063 W ES2022070063 W ES 2022070063W WO 2022171919 A1 WO2022171919 A1 WO 2022171919A1
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Prior art keywords
interface
virucidal
antibacterial
screen
mechanical ventilation
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PCT/ES2022/070063
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Spanish (es)
French (fr)
Inventor
José Miguel ALONSO ÍÑIGO
Original Assignee
Fundación Para La Investigación Del Hospital Universitario Y Politécnico La Fe De La Comunidad Valenciana
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Publication of WO2022171919A1 publication Critical patent/WO2022171919A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/05—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches protecting only a particular body part
    • A41D13/11—Protective face masks, e.g. for surgical use, or for use in foul atmospheres
    • 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
    • A61M15/00—Inhalators
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks

Definitions

  • the present invention relates to an antibacterial and virucidal interface or mask (hereinafter interface) for use in non-invasive mechanical ventilation (hereinafter NIMV) of patients with acute or chronic respiratory failure (hereinafter AKI).
  • interface non-invasive mechanical ventilation
  • AKI acute or chronic respiratory failure
  • the object of the invention is to provide a protection interface that provides safety against the presence of pathogenic agents.
  • the elements that make up the interface are made of thermoplastic materials suitable for sterilization and disinfection, and have silver ions in their composition to give them an antibacterial and virucidal character.
  • NIMV is a form of mechanical ventilatory support characterized by the absence of tracheal intubation. This is a widely used technique since the 1990s for the treatment of various forms of acute respiratory failure (ARI) and chronic respiratory failure (hereinafter CRI). In fact, numerous studies have shown the superiority of NIMV over conventional invasive ventilation (IMV) in certain patients.
  • IMV invasive ventilation
  • NIMV neurodegenerative disease 2019
  • the mask or interface being a differentiating element between NIMV and IMV that is essential for the success of NIMV since, in its form, , composition, ergonomics and quality depend on comfort, acceptance by the patient and, to a large extent, the success of the treatment.
  • NIMV is a highly used ventilatory support treatment in patients with acute respiratory failure due to COVID-19 disease. So, studies Recent studies confirm that the use of NIMV makes it possible to reduce the mortality of COVID-19 patients, decrease their average hospital stay and consequently reduce the pressure on critical care units.
  • the device that is recommended fully solves the aforementioned problems, since it offers an antibacterial and virucidal interface that increases the safety of patients and health professionals to minimize the spread of airborne infectious diseases - as is the case with COVID-19 disease - and improves patient tolerance to NIMV.
  • the interface of the invention provides a novel configuration that increases the comfort and ergonomics of the patient, guaranteeing a longer treatment.
  • the antibacterial and virucidal interface is conceived for a main application use in the hospital and outpatient setting, specifically in the treatment of any patient requiring NIMV, including for patients undergoing endoscopic procedures under sedation or anesthesia. Likewise, its application is especially indicated in patients with COVID-19 due to its viricidal properties, with the consequent decrease in the infectivity of said patients during NIMV.
  • the interface of the present invention covers, at least, the patient's mouth and nose, its configuration providing antibacterial and virucidal capabilities. In this sense, the interface developed is made up of, at least:
  • the contact component being composed of a flexible material of TPU (thermoplastic polyurethane), TPE (thermoplastic elastomer) or silicone, where the flexible material is formed based on silver ions,
  • a body in the form of a ring, made up of a rigid thermoplastic material based on silver ions.
  • This rigid thermoplastic material is made up of polypropylene, polyethylene, polyamide, acrylonitrile-butadiene-styrene (ABS) or acrylonitrile-styrene-acrylate (ASA), and where the body is provided with anchors for harnesses, and
  • thermoplastic compound based on silver ions.
  • Said transparent or translucent thermoplastic compound is constituted by polycarbonate, polypropylene or polyethylene.
  • the contact component, the body and the screen that form the interface are coupled together, providing a hermetic seal that keeps them properly coupled and holds them together.
  • the contact component is fixed to the screen by means of coupling means, both the contact component and the screen being fixed to the body by means of joining elements.
  • all the elements that make up the antibacterial and virucidal interface are made up of thermoplastic materials suitable for sterilization and disinfection based on silver ions to provide them with an antibacterial and virucidal character.
  • thermoplastic materials that make up the contact component, the body, the screen and the connection port that make up the interface of the invention have a saturation of silver ions in a range between 3% and 9%.
  • thermoplastic materials can have a universal polymeric resin, which is introduced as an additive compatible with the thermoplastic materials.
  • the universal polymeric resin facilitates polymerization and subsequent migration to the surface of the silver ions to generate the antibacterial and virucidal capacity of the interface of the present invention.
  • the antibacterial and virucidal interface object of the invention provides a plastic armor that offers a protection barrier against viruses, as it is made with a material with virucidal capacity that inhibits and prevents the passage of active viruses and live germs, mainly respiratory viruses, delaying or preventing their passage to the patient who carries the developed interface, and minimizing their dispersion into the environment.
  • the interface provides an oronasal seal covering the mouth and nose, following the anatomical contour of both and leaving the eyes and other structures of the face free.
  • the interface provides a total facial seal, so that it covers practically the entire face, including the eyes. This second realization of the interface provides an increase in comfort for patients, allowing prolonged treatments.
  • the interface of the present invention includes on the screen, at least, a secondary connector port as an elbow-shaped piece for the introduction of an endoscope.
  • the interface screen includes a connection port for NIMV and a secondary connector port as an elbow-shaped part for inserting the endoscope or fiberoptic bronchoscope.
  • this interface allows endoscopy or fiberoptic bronchoscopy to be performed on the patient and simultaneously ventilated. Likewise, this interface provides a seal covering the mouth and nose.
  • any of the three preferred embodiments of the interface described is made up of a material with antibacterial and virucidal properties, which generates a reduction in the risk of infection and an increase in safety for patients and healthcare professionals.
  • the use of the interface of the present invention in the application of NIMV represents an evident improvement in the treatment of patients with ARI, not only with COVID-19, but for patients with any other acute or chronic respiratory pathology.
  • the impact of better treatment and ventilatory management of these patients affects a shorter hospital stay, less admission to critical care units and a lower rate of nosocomial infection.
  • NIMV is a very widespread technique among the different medical specialties, being a transversal treatment. Therefore, the inclusion of the interface of the present invention, which improves the quality of therapy, directly affects the quality of care.
  • the materials that make up the interface of the invention allow it to be easily replicated by fusion and material deposition (FDM) technology, by resin sintering (SLA) prototyping technology and with most technologies. rapid prototyping using thermoplastic materials.
  • FDM fusion and material deposition
  • SLA resin sintering
  • Figure 1. Shows a front view of the antibacterial and virucidal interface for non-invasive mechanical ventilation according to a preferred embodiment of the invention.
  • Figure 2. Shows a rear view of the contact component that forms part of the antibacterial and virucidal interface for non-invasive mechanical ventilation according to the preferred embodiment of the invention represented in the previous figure.
  • Figure 3. Shows a rear perspective view of the contact component shown in figure 2.
  • Figure 4.- Shows a front view of the body that forms part of the interface antibacterial and virucidal for non-invasive mechanical ventilation according to the preferred embodiment of the invention shown in figure 1.
  • Figure 5. Shows a perspective view of the screen that forms part of the antibacterial and virucidal interface for non-invasive mechanical ventilation according to the preferred embodiment of the invention shown in figure 1.
  • Figure 6. Shows an exploded side view of the elements that make up the antibacterial and virucidal interface for non-invasive mechanical ventilation according to the preferred embodiment of the invention shown in figure 1.
  • Figure 7. Shows a detailed view of the elements represented in the previous figure that form the antibacterial and virucidal interface for non-invasive mechanical ventilation according to the preferred embodiment of the invention.
  • the figures outlined show a preferred embodiment of the invention relating to the antibacterial and virucidal interface for non-invasive mechanical ventilation.
  • figures 1, 6 and 7 show a representation of the three elements that preferably make up the device of the present invention, namely: a contact component (1), a body (2) and a screen (3) , all of them coupled together by hermetic closure.
  • the contact component (1) allows the interface to be sealed to the patient's face, and is made up of a flexible TPU, TPE or silicone material.
  • Said flexible material is formed on the basis of silver ions, its flexible behavior being an outstanding property that provides comfort to the wearer of this interface.
  • the body (2) has a ring-like shape - as shown in figure 2 and figure 3 - and is made up of a rigid thermoplastic material based on silver ions, which provides robustness. to the set.
  • the rigid thermoplastic material of the body (2) is made up of polypropylene, polyethylene, polyamide, acrylonitrile-butadiene-styrene (ABS) or acrylonitrile-styrene-acrylate (ASA).
  • the body (2) of the interface of the invention is provided with anchors (5) in which harnesses will be arranged to facilitate fastening to the patient and thus prevent displacement. .
  • the screen (3) is made up of a transparent or translucent material of a thermoplastic compound based on silver ions.
  • the thermoplastic compound of the screen (3) is made up of polycarbonate, polypropylene or polyethylene.
  • the screen (3) is provided with a connection port (4), as shown in figure 5, the connection port (4) being made up of a thermoplastic compound based on silver ions.
  • Figure 6 and Figure 7 show the way in which the three elements that make up the antibacterial and virucidal interface of the invention are coupled together by a hermetic seal.
  • the contact component (1) is fixed to the screen (3) by coupling means.
  • the coupling means are preferably formed by a perimeter projection (6) arranged on the contact component (1) and a complementary perimeter channel (7) arranged on the screen (3), so as to enable coupling among them.
  • the contact component (1) and the screen (3) are fixed to the body (2) by means of joining elements.
  • the joining elements are formed by a perimeter projection (8) arranged on the screen (3) and a complementary perimeter groove (9) located on the body (2), as seen in figures 5, 6 and 7 .
  • the elements that make up this interface are made up of thermoplastic materials suitable for sterilization and disinfection, so that once used by a patient, it can be sterilized and disinfected by the means commonly known to its use in another patient.
  • thermoplastic materials formed on the basis of silver ions gives the interface an antibacterial and virucidal character, an innovative aspect of this technical development.
  • the interface covers the entire face of the patient, that is, it has a facial character.
  • this embodiment is not limiting of the invention, so that the antibacterial and virucidal interface for non-invasive mechanical ventilation can materialize in an oronasal embodiment, that is, one that covers the mouth and nose, being equally effective.
  • the screen (3) of the antibacterial and virucidal interface includes at least one secondary connector port -not shown in the figures that accompany this description- as an elbow-shaped part for the introduction of an endoscope.
  • the secondary connector port is also integrated by a thermoplastic compound based on silver ions. This realization of the interface allows endoscopy or fiber endoscopy to be performed on the patient and simultaneously ventilate him.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Public Health (AREA)
  • Emergency Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Textile Engineering (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)

Abstract

The invention discloses an antibacterial and virucidal interface for non-invasive mechanical ventilation, formed by a contact component made of flexible material, a body made of rigid material and having anchor points for straps, and a screen of transparent or translucent material comprising a connection port, such that the contact component is fixed to the screen by means of coupling means which are in turn attached to the body by means of joining elements, all these being coupled together by an airtight closure and consisting of thermoplastic materials suitable for silver ion-based sterilisation and disinfection, to endow them with an antibacterial and virucidal nature. Advantageously, the interface provides a rapid response rate for production and supply, and the manufacture of the interface is also feasible using traditional methods involving the injection and thermoforming of plastic materials.

Description

INTERFASE ANTIBACTERIANA Y VIRICIDA PARA VENTILACIÓN MECÁNICA NO INVASIVA
Figure imgf000003_0001
ANTIBACTERIAL AND VIRICIDAL INTERFACE FOR NON-INVASIVE MECHANICAL VENTILATION
Figure imgf000003_0001
OBJETO DE LA INVENCIÓN OBJECT OF THE INVENTION
La presente invención se refiere a una interfase o mascarilla (en adelante interfase) antibacteriana y viricida para su uso en la ventilación mecánica no invasiva (en adelante VMNI) de pacientes con insuficiencia respiratoria aguda (en adelante IRA) o crónica. The present invention relates to an antibacterial and virucidal interface or mask (hereinafter interface) for use in non-invasive mechanical ventilation (hereinafter NIMV) of patients with acute or chronic respiratory failure (hereinafter AKI).
El objeto de la invención es proporcionar una interfase de protección que aporte seguridad frente a la presencia de agentes patógenos. Para ello, los elementos que integran la interfase están fabricados con materiales termoplásticos aptos para su esterilización y desinfección, y presentan en su composición iones de plata para otorgar el carácter antibacteriano y viricida. The object of the invention is to provide a protection interface that provides safety against the presence of pathogenic agents. To do this, the elements that make up the interface are made of thermoplastic materials suitable for sterilization and disinfection, and have silver ions in their composition to give them an antibacterial and virucidal character.
ANTECEDENTES DE LA INVENCIÓN BACKGROUND OF THE INVENTION
La VMNI es una forma de soporte ventilatorio mecánico que se caracteriza por la ausencia de intubación traqueal. Se trata de una técnica ampliamente utilizada desde la década de los 90 para el tratamiento de diversas formas de insuficiencia respiratoria aguda (IRA) y de insuficiencia respiratoria crónica (en adelante IRC). De hecho, numerosos estudios han demostrado la superioridad del VMNI frente a la ventilación invasiva convencional (VMI) en ciertos pacientes. NIMV is a form of mechanical ventilatory support characterized by the absence of tracheal intubation. This is a widely used technique since the 1990s for the treatment of various forms of acute respiratory failure (ARI) and chronic respiratory failure (hereinafter CRI). In fact, numerous studies have shown the superiority of NIMV over conventional invasive ventilation (IMV) in certain patients.
El interés creciente en la VMNI ha llevado al desarrollo progresivo de todos los componentes tecnológicos asociados a la misma, siendo la mascarilla o interfase un elemento diferenciador entre la VMNI y la VMI que resulta esencial para el éxito de la VMNI ya que, de su forma, composición, ergonomía y calidad dependen el confort, la aceptación por parte del paciente y, en gran medida, el éxito del tratamiento. The growing interest in NIMV has led to the progressive development of all the technological components associated with it, with the mask or interface being a differentiating element between NIMV and IMV that is essential for the success of NIMV since, in its form, , composition, ergonomics and quality depend on comfort, acceptance by the patient and, to a large extent, the success of the treatment.
Cabe señalar que la VMNI es un tratamiento de soporte ventilatorio altamente empleado en pacientes con insuficiencia respiratoria aguda por la enfermedad COVID-19. Así, estudios recientes permiten confirmar que el empleo de VMNI posibilita la disminución de la mortalidad de los pacientes por COVID-19, disminuye su estancia media hospitalaria y consecuentemente disminuye la presión sobre las unidades de cuidados críticos. It should be noted that NIMV is a highly used ventilatory support treatment in patients with acute respiratory failure due to COVID-19 disease. So, studies Recent studies confirm that the use of NIMV makes it possible to reduce the mortality of COVID-19 patients, decrease their average hospital stay and consequently reduce the pressure on critical care units.
Sin embargo, el uso prolongado de las interfases conocidas en VMNI puede generar efectos adversos como son ulceras por presión y cierta intolerancia debido a la variabilidad anatómica individual. However, the prolonged use of known interfaces in NIMV can generate adverse effects such as pressure ulcers and a certain intolerance due to individual anatomical variability.
Por todo lo anterior, se concluye que son conocidas interfases para la VMNI, pero todas ellas adolecen de capacidad para evitar la dispersión y la permanencia en su superficie de agentes patógenos. For all of the above, it is concluded that there are known interfaces for NIMV, but all of them lack the capacity to prevent the dispersion and permanence of pathogens on their surface.
Es por ello que el solicitante del presente modelo de utilidad detecta la necesidad de ofrecer una interfase que impida la proliferación de bacterias sobre su superficie y que, simultáneamente, garantice la desnaturalización de los posibles virus presentes, siendo además una solución de alta confortabilidad que fomente la tolerancia de su uso por parte del paciente. That is why the applicant of this utility model detects the need to offer an interface that prevents the proliferation of bacteria on its surface and that, simultaneously, guarantees the denaturation of the possible viruses present, being also a highly comfortable solution that promotes tolerance of its use by the patient.
DESCRIPCIÓN DE LA INVENCIÓN DESCRIPTION OF THE INVENTION
El dispositivo que se preconiza resuelve de forma plenamente satisfactoria la problemática anteriormente expuesta, ya que ofrece una interfase antibacteriana y viricida que permite aumentar la seguridad de pacientes y profesionales sanitarios para minimizar los contagios de enfermedades infecciosas transmisibles por el aire - como es el caso de la enfermedad COVID-19 - y mejora la tolerancia de los pacientes a la VMNI. De esta forma, la interfase de la invención aporta una novedosa configuración que aumenta la confortabilidad y ergonomía del paciente, garantizando un tratamiento más prolongado. The device that is recommended fully solves the aforementioned problems, since it offers an antibacterial and virucidal interface that increases the safety of patients and health professionals to minimize the spread of airborne infectious diseases - as is the case with COVID-19 disease - and improves patient tolerance to NIMV. In this way, the interface of the invention provides a novel configuration that increases the comfort and ergonomics of the patient, guaranteeing a longer treatment.
La interfase antibacteriana y viricida se concibe para un uso de aplicación principal en el ámbito hospitalario y extrahospitalario, concretamente en el tratamiento de cualquier paciente que precise VMNI, incluso para pacientes sometidos a procedimientos endoscópicos bajo sedación o anestesia. Igualmente, su aplicación está especialmente indicada en pacientes con COVID-19 debido a sus propiedades viricidas, con la consiguiente disminución de la infectividad de dichos pacientes durante la VMNI. Concretamente, la interfase de la presente invención cubre, al menos, la boca y la nariz del paciente, aportando su configuración capacidades antibacterianas y viricidas. En este sentido, la interfase desarrollada está integrada por, al menos: The antibacterial and virucidal interface is conceived for a main application use in the hospital and outpatient setting, specifically in the treatment of any patient requiring NIMV, including for patients undergoing endoscopic procedures under sedation or anesthesia. Likewise, its application is especially indicated in patients with COVID-19 due to its viricidal properties, with the consequent decrease in the infectivity of said patients during NIMV. Specifically, the interface of the present invention covers, at least, the patient's mouth and nose, its configuration providing antibacterial and virucidal capabilities. In this sense, the interface developed is made up of, at least:
- un componente de contacto para el sellado al paciente, estando el componente de contacto integrado por un material flexible de TPU (siglas en inglés de poliuretano termoplástico), TPE (siglas en inglés de elastómero termoplástico) o silicona, donde el material flexible está formado en base a iones de plata, - a contact component for sealing to the patient, the contact component being composed of a flexible material of TPU (thermoplastic polyurethane), TPE (thermoplastic elastomer) or silicone, where the flexible material is formed based on silver ions,
- un cuerpo, a modo de anillo, integrado por un material rígido termoplástico en base a iones de plata. Este material rígido termoplástico se constituye por polipropileno, polietileno, poliamida, acrilonitriio-butadieno-estireno (ABS) o acriionitrilo-estireno- acrilato (ASA), y donde el cuerpo está provisto de unos anclajes para arneses, y- a body, in the form of a ring, made up of a rigid thermoplastic material based on silver ions. This rigid thermoplastic material is made up of polypropylene, polyethylene, polyamide, acrylonitrile-butadiene-styrene (ABS) or acrylonitrile-styrene-acrylate (ASA), and where the body is provided with anchors for harnesses, and
- una pantalla provista de, al menos, un puerto de conexión, estando la pantalla integrada por un material transparente o traslucido de un compuesto termoplástico en base a iones de plata. Dicho compuesto termoplástico transparente o traslucido se constituye por policarbonato, polipropileno o polietileno. - a screen provided with at least one connection port, the screen being made of a transparent or translucent material of a thermoplastic compound based on silver ions. Said transparent or translucent thermoplastic compound is constituted by polycarbonate, polypropylene or polyethylene.
De esta forma, el componente de contacto, el cuerpo y la pantalla que forman la interfase quedan acoplados entre sí otorgando un cierre hermético que los mantiene debidamente acoplados y los mantiene unidos. Para ello, el componente de contacto queda fijado a la pantalla mediante unos medios de acoplamiento, quedado tanto el componente de contacto como la pantalla fijados al cuerpo mediante unos elementos de unión. In this way, the contact component, the body and the screen that form the interface are coupled together, providing a hermetic seal that keeps them properly coupled and holds them together. For this, the contact component is fixed to the screen by means of coupling means, both the contact component and the screen being fixed to the body by means of joining elements.
Ventajosamente, todos los elementos que integran la interfase antibacteriana y viricida se integran por materiales termoplásticos aptos para esterilización y desinfección en base a iones de plata para dotarlos de un carácter antibacteriano y viricida. Advantageously, all the elements that make up the antibacterial and virucidal interface are made up of thermoplastic materials suitable for sterilization and disinfection based on silver ions to provide them with an antibacterial and virucidal character.
Opcionalmente, los materiales termoplásticos que integran el componente de contacto, el cuerpo, la pantalla y el puerto de conexión que integran la interfase de la invención presentan una saturación de iones de plata en un rango entre el 3% y el 9%. Optionally, the thermoplastic materials that make up the contact component, the body, the screen and the connection port that make up the interface of the invention have a saturation of silver ions in a range between 3% and 9%.
Igualmente, de forma opcional, los materiales termoplásticos pueden presentar una resina polimérica universal, la cual se introduce como un aditivo compatible con los materiales termoplásticos. De esta forma, la resina polimérica universal facilita la polimerización y posterior migración a la superficie de los iones de plata para generar la capacidad antibacteriana y viricida de la interfase de la presente invención. Also, optionally, the thermoplastic materials can have a universal polymeric resin, which is introduced as an additive compatible with the thermoplastic materials. In this way, the universal polymeric resin facilitates polymerization and subsequent migration to the surface of the silver ions to generate the antibacterial and virucidal capacity of the interface of the present invention.
Por todo lo anterior, la interfase antibacteriana y viricida objeto de la invención proporciona una armadura plástica que ofrece una barrera de protección frente a virus, al estar realizada con un material con capacidad viricida que inhibe y evita el paso de virus activos y gérmenes vivos, principalmente virus respiratorios, retardando o evitando el paso de éstos al paciente que porta la interfase desarrollada, y minimizando la dispersión de los mismos al ambiente. For all of the above, the antibacterial and virucidal interface object of the invention provides a plastic armor that offers a protection barrier against viruses, as it is made with a material with virucidal capacity that inhibits and prevents the passage of active viruses and live germs, mainly respiratory viruses, delaying or preventing their passage to the patient who carries the developed interface, and minimizing their dispersion into the environment.
En una realización preferente de la invención, la interfase proporciona un sellado oronasal cubriendo la boca y la nariz, siguiendo el contorno anatómico de ambas y dejando libres los ojos y resto de estructuras de la cara. In a preferred embodiment of the invention, the interface provides an oronasal seal covering the mouth and nose, following the anatomical contour of both and leaving the eyes and other structures of the face free.
En una segunda realización preferente de la invención, la interfase proporciona un sellado facial total, de forma que cubre prácticamente toda la cara, incluyendo los ojos. Esta segunda realización de la interfase aporta un aumento de confort en los pacientes permitiendo tratamientos prolongados. In a second preferred embodiment of the invention, the interface provides a total facial seal, so that it covers practically the entire face, including the eyes. This second realization of the interface provides an increase in comfort for patients, allowing prolonged treatments.
En una tercera realización preferente de la invención, la interfase de la presente invención incluye en la pantalla, al menos, un puerto conector secundario a modo de pieza con forma de codo para la introducción de un endoscopio. Concretamente en esta tercera realización preferente de la invención, la pantalla de la interfase incluye un puerto de conexión para la VMNI y un puerto conector secundario a modo de pieza con forma de codo para la introducción del endoscopio o fibrobroncoscopio. Ventajosamente, esta interfase permite realizar la endoscopia o fibrobroncoscopia al paciente y simultáneamente ventilarlo. Igualmente, esta interfase proporciona un sellado cubriendo la boca y nariz. In a third preferred embodiment of the invention, the interface of the present invention includes on the screen, at least, a secondary connector port as an elbow-shaped piece for the introduction of an endoscope. Specifically in this third preferred embodiment of the invention, the interface screen includes a connection port for NIMV and a secondary connector port as an elbow-shaped part for inserting the endoscope or fiberoptic bronchoscope. Advantageously, this interface allows endoscopy or fiberoptic bronchoscopy to be performed on the patient and simultaneously ventilated. Likewise, this interface provides a seal covering the mouth and nose.
Así, cualquiera de las tres realizaciones preferentes descritas de la interfase está integrada por un material con propiedades antibacterianas y viricidas, el cual genera una disminución del riesgo de infección y un aumento de la seguridad para los pacientes y profesionales sanitarios. Thus, any of the three preferred embodiments of the interface described is made up of a material with antibacterial and virucidal properties, which generates a reduction in the risk of infection and an increase in safety for patients and healthcare professionals.
Por otro lado, el uso de la interfase de la presente invención en la aplicación de VMNI supone una mejora evidente en el tratamiento de pacientes con IRA, no solo con COVID-19, sino para pacientes con cualquier otra patología respiratoria aguda o crónica. El impacto de un mejor tratamiento y manejo ventilatorio de estos pacientes incide en una menor estancia hospitalaria, menor ingreso en las unidades de cuidados críticos y menor tasa de infección nosocomial. Además, la VMNI es una técnica muy extendida entre las diferentes especialidades médicas siendo un tratamiento transversal. Por ello, la inclusión de la interfase de la presente invención, la cual mejora la calidad de la terapia, incide de forma directa en la calidad asistencial. On the other hand, the use of the interface of the present invention in the application of NIMV represents an evident improvement in the treatment of patients with ARI, not only with COVID-19, but for patients with any other acute or chronic respiratory pathology. The impact of better treatment and ventilatory management of these patients affects a shorter hospital stay, less admission to critical care units and a lower rate of nosocomial infection. In addition, NIMV is a very widespread technique among the different medical specialties, being a transversal treatment. Therefore, the inclusion of the interface of the present invention, which improves the quality of therapy, directly affects the quality of care.
Finalmente, resaltar que los materiales que integran la interfase de la invención permiten que sea fácilmente replicable por la tecnología de fusión y deposición de material (FDM), por la tecnología de prototipado en sinterizado de resina (SLA) y con la mayoría de las tecnologías de prototipado rápido que usan materiales termoplásticos. Así, ventajosamente la interfase desarrollada ofrece una rápida tasa de respuesta para la producción y abastecimiento, siendo incluso viable su fabricación por métodos tradicionales de inyección y termo-conformado de materiales plásticos. Finally, it should be noted that the materials that make up the interface of the invention allow it to be easily replicated by fusion and material deposition (FDM) technology, by resin sintering (SLA) prototyping technology and with most technologies. rapid prototyping using thermoplastic materials. Thus, advantageously, the developed interface offers a fast response rate for production and supply, and its manufacture is even feasible by traditional methods of injection and thermoforming of plastic materials.
BREVE DESCRIPCIÓN DE LOS DIBUJOS BRIEF DESCRIPTION OF THE DRAWINGS
Para completar la descripción que seguidamente se va a realizar y con objeto de ayudar a una mejor comprensión de las características del invento, se acompaña como parte integrante de dicha descripción, un juego de planos en donde con carácter ilustrativo y no limitativo, se ha representado lo siguiente: To complete the description that will be made below and in order to help a better understanding of the characteristics of the invention, a set of plans is attached as an integral part of said description, where for illustrative and non-limiting purposes, it has been represented the next:
La figura 1 .- Muestra una vista frontal de la interfase antibacteriana y viricida para ventilación mecánica no invasiva conforme a una realización preferente de la invención. Figure 1.- Shows a front view of the antibacterial and virucidal interface for non-invasive mechanical ventilation according to a preferred embodiment of the invention.
La figura 2.- Muestra una vista posterior del componente de contacto que forma parte de la interfase antibacteriana y viricida para ventilación mecánica no invasiva conforme a la realización preferente de la invención representada en la figura anterior. Figure 2.- Shows a rear view of the contact component that forms part of the antibacterial and virucidal interface for non-invasive mechanical ventilation according to the preferred embodiment of the invention represented in the previous figure.
La figura 3.- Muestra una vista posterior en perspectiva del componente de contacto representado en la figura 2. Figure 3.- Shows a rear perspective view of the contact component shown in figure 2.
La figura 4.- Muestra una vista frontal del cuerpo que forma parte de la interfase antibacteriana y viricida para ventilación mecánica no invasiva conforme a la realización preferente de la invención representada en la figura 1. Figure 4.- Shows a front view of the body that forms part of the interface antibacterial and virucidal for non-invasive mechanical ventilation according to the preferred embodiment of the invention shown in figure 1.
La figura 5.- Muestra una vista en perspectiva de la pantalla que forma parte de la interfase antibacteriana y viricida para ventilación mecánica no invasiva conforme a la realización preferente de la invención representada en la figura 1. Figure 5.- Shows a perspective view of the screen that forms part of the antibacterial and virucidal interface for non-invasive mechanical ventilation according to the preferred embodiment of the invention shown in figure 1.
La figura 6.- Muestra una vista lateral en explosión de los elementos que integran la interfase antibacteriana y viricida para ventilación mecánica no invasiva conforme a la realización preferente de la invención representada en la figura 1. Figure 6.- Shows an exploded side view of the elements that make up the antibacterial and virucidal interface for non-invasive mechanical ventilation according to the preferred embodiment of the invention shown in figure 1.
La figura 7.- Muestra una vista en detalle de los elementos representados en la figura anterior que forman la interfase antibacteriana y viricida para ventilación mecánica no invasiva conforme a la realización preferente de la invención. Figure 7.- Shows a detailed view of the elements represented in the previous figure that form the antibacterial and virucidal interface for non-invasive mechanical ventilation according to the preferred embodiment of the invention.
REALIZACIÓN PREFERENTE DE LA INVENCIÓN PREFERRED EMBODIMENT OF THE INVENTION
En las figuras reseñadas se observa un ejemplo de realización preferente de la invención relativa a la interfase antibacteriana y viricida para ventilación mecánica no invasiva. The figures outlined show a preferred embodiment of the invention relating to the antibacterial and virucidal interface for non-invasive mechanical ventilation.
Concretamente, las figuras 1 , 6 y 7 muestran una representación de los tres elementos que, preferentemente, conforman el dispositivo de la presente invención, a saber: un componente de contacto (1), un cuerpo (2) y una pantalla (3), todos ellos acoplados entre sí por cierre hermético. Specifically, figures 1, 6 and 7 show a representation of the three elements that preferably make up the device of the present invention, namely: a contact component (1), a body (2) and a screen (3) , all of them coupled together by hermetic closure.
Así, el componente de contacto (1) permite el sellado de la interfase a la cara del paciente, y está integrado por un material flexible de TPU, TPE o silicona. Dicho material flexible está formado en base a iones de plata, siendo su comportamiento flexible una destacada propiedad que dota de confortabilidad al usuario portador de la presente interfase. Thus, the contact component (1) allows the interface to be sealed to the patient's face, and is made up of a flexible TPU, TPE or silicone material. Said flexible material is formed on the basis of silver ions, its flexible behavior being an outstanding property that provides comfort to the wearer of this interface.
Por otro lado, el cuerpo (2), presenta una forma a modo de anillo - tal como queda representado en la figura 2 y la figura 3 - y está integrado por un material rígido termoplástico en base a iones de plata, el cual otorga robustez al conjunto. El material rígido termoplástico del cuerpo (2) se constituye por polipropileno, polietileno, poliamida, acriionitrilo-butadieno-estireno (ABS) o acrilonltnlo-estireno-acrilato (ASA). On the other hand, the body (2), has a ring-like shape - as shown in figure 2 and figure 3 - and is made up of a rigid thermoplastic material based on silver ions, which provides robustness. to the set. The rigid thermoplastic material of the body (2) is made up of polypropylene, polyethylene, polyamide, acrylonitrile-butadiene-styrene (ABS) or acrylonitrile-styrene-acrylate (ASA).
Tal como se observa en la figura 1 y en la figura 4, el cuerpo (2) de la interfase de la invención está provisto de unos anclajes (5) en los que se dispondrán arneses para facilitar la sujeción al paciente y así evitar su desplazamiento. As can be seen in Figure 1 and Figure 4, the body (2) of the interface of the invention is provided with anchors (5) in which harnesses will be arranged to facilitate fastening to the patient and thus prevent displacement. .
Finalmente, la pantalla (3) está integrada por un material transparente o traslucido de un compuesto termoplástico en base a iones de plata. Así, el compuesto termoplástico de la pantalla (3) se constituye por policarbonato, polipropileno o polietileno. Preferentemente, la pantalla (3) está provista de un puerto de conexión (4), tal como se observa en la figura 5, estando el puerto de conexión (4) integrado por un compuesto termoplástico en base a iones de plata. Finally, the screen (3) is made up of a transparent or translucent material of a thermoplastic compound based on silver ions. Thus, the thermoplastic compound of the screen (3) is made up of polycarbonate, polypropylene or polyethylene. Preferably, the screen (3) is provided with a connection port (4), as shown in figure 5, the connection port (4) being made up of a thermoplastic compound based on silver ions.
La figura 6 y la figura 7 permiten observar la forma en la que los tres elementos que integran la interfase antibacteriana y viricida de la invención quedan acoplados entre sí por un cierre hermético. En este sentido, el componente de contacto (1) queda fijado a la pantalla (3) mediante unos medios de acoplamiento. Concretamente, los medios de acoplamiento están formados, preferentemente, por un resalte perimetral (6) dispuesto en el componente de contacto (1) y un canal perimetral complementario (7) dispuesto en la pantalla (3), de forma que se posibilita el acoplamiento entre ellos. Figure 6 and Figure 7 show the way in which the three elements that make up the antibacterial and virucidal interface of the invention are coupled together by a hermetic seal. In this sense, the contact component (1) is fixed to the screen (3) by coupling means. Specifically, the coupling means are preferably formed by a perimeter projection (6) arranged on the contact component (1) and a complementary perimeter channel (7) arranged on the screen (3), so as to enable coupling among them.
Igualmente, el componente de contacto (1) y la pantalla (3) quedan fijados al cuerpo (2) mediante unos elementos de unión. Preferentemente, los elementos de unión están formados por un saliente perimetral (8) dispuesto en la pantalla (3) y una hendidura perimetral complementaria (9) localizada en el cuerpo (2), tal como se observa en las figuras 5, 6 y 7. Likewise, the contact component (1) and the screen (3) are fixed to the body (2) by means of joining elements. Preferably, the joining elements are formed by a perimeter projection (8) arranged on the screen (3) and a complementary perimeter groove (9) located on the body (2), as seen in figures 5, 6 and 7 .
De esta manera, los elementos que integran la interfase objeto de la invención quedan fácilmente acoplados entre sí mediante la aplicación de presión. In this way, the elements that make up the interface object of the invention are easily coupled together by applying pressure.
Ventajosamente, los elementos que integran la presente interfase se integran por materiales termoplásticos aptos para esterilización y desinfección, por lo que una vez utilizada por un paciente podrá ser esterilizada y desinfectada por los medios comúnmente conocidos para su uso en otro paciente. Igualmente, la inclusión de materiales termoplásticos formados en base a iones de plata otorga el carácter antibacteriano y viricida a la interfase, aspecto innovador del presente desarrollo técnico. En la realización preferente de la invención ilustrada en las figuras que acompañan la presente descripción, la interfase cubre la totalidad de la cara del paciente, es decir presenta un carácter facial. Sin embargo, esta realización no es limitativa de la invención, de forma que la interfase antibacteriana y viricida para ventilación mecánica no invasiva puede materializarse en una realización oronasal, es decir aquella que cubre boca y nariz, siendo igualmente efectiva. Advantageously, the elements that make up this interface are made up of thermoplastic materials suitable for sterilization and disinfection, so that once used by a patient, it can be sterilized and disinfected by the means commonly known to its use in another patient. Likewise, the inclusion of thermoplastic materials formed on the basis of silver ions gives the interface an antibacterial and virucidal character, an innovative aspect of this technical development. In the preferred embodiment of the invention illustrated in the figures that accompany this description, the interface covers the entire face of the patient, that is, it has a facial character. However, this embodiment is not limiting of the invention, so that the antibacterial and virucidal interface for non-invasive mechanical ventilation can materialize in an oronasal embodiment, that is, one that covers the mouth and nose, being equally effective.
Finalmente, cabe resalta que, opcionalmente, la pantalla (3) de la interfase antibacteriana y viricida incluye, al menos, un puerto conector secundario -no representado en las figuras que acompañan la presente descripción- a modo de pieza con forma de codo para la introducción de un endoscopio. Cabe destacar que el puerto conector secundario también se integra por un compuesto termoplástico en base a iones de plata. Esta realización de la interfase permite realizar la endoscopia o fibroendoscopia al paciente y simultáneamente ventilarlo. Finally, it should be noted that, optionally, the screen (3) of the antibacterial and virucidal interface includes at least one secondary connector port -not shown in the figures that accompany this description- as an elbow-shaped part for the introduction of an endoscope. It should be noted that the secondary connector port is also integrated by a thermoplastic compound based on silver ions. This realization of the interface allows endoscopy or fiber endoscopy to be performed on the patient and simultaneously ventilate him.

Claims

R E I V I N D I C A C I O N E S R E I V I N D I C A T I O N S
1a.- Interfase antibacteriana y viricida para ventilación mecánica no invasiva de las que cubre, al menos, boca y nariz, caracterizada por que comprende: 1st.- Antibacterial and virucidal interface for non-invasive mechanical ventilation covering, at least, the mouth and nose, characterized in that it comprises:
- Un componente de contacto (1) integrado por un material flexible de poliuretano termoplástico (TPU), elastómero termoplástico (TPE) o silicona, donde el material flexible está formado en base a iones de plata. - A contact component (1) made up of a flexible thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE) or silicone material, where the flexible material is formed on the basis of silver ions.
- Un cuerpo (2), a modo de anillo, integrado por un material rígido termoplástico en base a iones de plata, donde el material rígido termoplástico se constituye por polipropileno, polietileno, poliamida, acrilonitrilo-butadieno-estireno (ABS) o acrilonitrilo-estireno-acrilato (ASA), y donde el cuerpo (2) está provisto de unos anclajes (5) para arneses. - A body (2), in the form of a ring, made up of a rigid thermoplastic material based on silver ions, where the rigid thermoplastic material is made up of polypropylene, polyethylene, polyamide, acrylonitrile-butadiene-styrene (ABS) or acrylonitrile- styrene-acrylate (ASA), and where the body (2) is provided with anchors (5) for harnesses.
Una pantalla (3) provista de, al menos, un puerto de conexión (4), estando la pantalla (3) integrada por un material transparente o traslucido de un compuesto termoplástico en base a iones de plata, donde el compuesto termoplástico se constituye por policarbonato, polipropileno o polietileno. A screen (3) provided with at least one connection port (4), the screen (3) being made up of a transparent or translucent material of a thermoplastic compound based on silver ions, where the thermoplastic compound is made up of polycarbonate, polypropylene or polyethylene.
Donde el componente de contacto (1) queda fijado a la pantalla (3) mediante unos medios de acoplamiento, estando el componente de contacto (1) y la pantalla (3) fijados al cuerpo (2) mediante unos elementos de unión, de forma que todos ellos quedan acoplados entre sí por un cierre hermético e integrados por materiales termoplásticos aptos para la esterilización y desinfección. Where the contact component (1) is fixed to the screen (3) by means of coupling means, the contact component (1) and the screen (3) being fixed to the body (2) by means of joining elements, in the form that all of them are connected to each other by a hermetic seal and made of thermoplastic materials suitable for sterilization and disinfection.
2a.- Interfase antibacteriana y viricida para ventilación mecánica no invasiva, según reivindicación 1a, caracterizada por que los medios de acoplamiento están formados por un resalte perimetral (6) dispuesto en el componente de contacto (1) y un canal perimetral complementario (7) dispuesto en la pantalla (3). 2 .- Antibacterial and virucidal interface for non-invasive mechanical ventilation, according to claim 1, characterized in that the coupling means are formed by a perimeter projection (6) arranged in the contact component (1) and a complementary perimeter channel ( 7) arranged on the screen (3).
3a.- Interfase antibacteriana y viricida para ventilación mecánica no invasiva, según reivindicación 1a, caracterizada por que los elementos de unión están formados por un saliente perimetral (8) dispuesto en la pantalla (3) y una hendidura perimetral complementaria (9) localizada en el cuerpo (2). 4a.- Interfase antibacteriana y viricida para ventilación mecánica no invasiva, según reivindicación 1a, caracterizada por que el puerto de conexión (4) está integrado por un compuesto termoplástico en base a iones de plata. 3 .- Antibacterial and virucidal interface for non-invasive mechanical ventilation, according to claim 1, characterized in that the joining elements are formed by a perimeter projection (8) arranged on the screen (3) and a complementary perimeter slit (9) located in the body (2). 4 .- Antibacterial and virucidal interface for non-invasive mechanical ventilation, according to claim 1, characterized in that the connection port (4) is made up of a thermoplastic compound based on silver ions.
5a.- Interfase antibacteriana y viricida para ventilación mecánica no invasiva, según reivindicación 1a y 4a, caracterizada por que los materiales termoplásticos que integran el componente de contacto (1), el cuerpo (2), la pantalla (3) y el puerto de conexión (4) presentan una saturación de iones de plata en un rango entre el 3% y el 9%. 5 .- Antibacterial and virucidal interface for non-invasive mechanical ventilation, according to claim 1 and 4, characterized in that the thermoplastic materials that make up the contact component (1), the body (2), the screen (3) and the connection port (4) present a saturation of silver ions in a range between 3% and 9%.
6a.- Interfase antibacteriana y viricida para ventilación mecánica no invasiva, según reivindicación 1a, caracterizada por que los materiales termoplásticos presentan una resina polimérica universal como aditivo la cual es compatible con los materiales termoplásticos. 6 .- Antibacterial and virucidal interface for non-invasive mechanical ventilation, according to claim 1, characterized in that the thermoplastic materials have a universal polymeric resin as an additive which is compatible with thermoplastic materials.
7a.- Interfase antibacteriana y viricida para ventilación mecánica no invasiva, según reivindicación 1a, caracterizada por que la pantalla (3) está provista de, al menos, un puerto conector secundario a modo de pieza con forma de codo para la introducción de un endoscopio, estando el puerto conector secundario integrado por un compuesto termoplástico en base a iones de plata. 7 .- Antibacterial and virucidal interface for non-invasive mechanical ventilation, according to claim 1, characterized in that the screen (3) is provided with at least one secondary connector port as an elbow-shaped piece for the introduction of an endoscope, the secondary connector port being made up of a thermoplastic compound based on silver ions.
8a.- Interfase antibacteriana y viricida para ventilación mecánica no invasiva, según cualquiera de las reivindicaciones anteriores, caracterizada por que presenta un carácter facial para cubrir la totalidad de la cara del paciente. 8 .- Antibacterial and virucidal interface for non-invasive mechanical ventilation, according to any of the preceding claims, characterized in that it has a facial character to cover the entire face of the patient.
PCT/ES2022/070063 2021-02-10 2022-02-09 Antibacterial and virucidal interface for non-invasive mechanical ventilation WO2022171919A1 (en)

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ES202130263U ES1262449Y (en) 2021-02-10 2021-02-10 ANTIBACTERIAL AND VIRICIDE INTERFACE FOR NON-INVASIVE MECHANICAL VENTILATION

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