WO2021219912A1 - Masque de protection pour la manipulation nasale - Google Patents

Masque de protection pour la manipulation nasale Download PDF

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Publication number
WO2021219912A1
WO2021219912A1 PCT/ES2021/070275 ES2021070275W WO2021219912A1 WO 2021219912 A1 WO2021219912 A1 WO 2021219912A1 ES 2021070275 W ES2021070275 W ES 2021070275W WO 2021219912 A1 WO2021219912 A1 WO 2021219912A1
Authority
WO
WIPO (PCT)
Prior art keywords
opening
nasal
mask according
mask
protective mask
Prior art date
Application number
PCT/ES2021/070275
Other languages
English (en)
Spanish (es)
Inventor
Jaime Viera Artiles
Jose Julián VALDIANDE GUTIÉRREZ
Jose Miguel LÓPEZ HIGUERA
Original Assignee
Servicio Cántabro De Salud
Universidad De Cantabria
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Servicio Cántabro De Salud, Universidad De Cantabria filed Critical Servicio Cántabro De Salud
Publication of WO2021219912A1 publication Critical patent/WO2021219912A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A41WEARING APPAREL
    • A41DOUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/05Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches protecting only a particular body part
    • A41D13/11Protective face masks, e.g. for surgical use, or for use in foul atmospheres
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/233Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the nose, i.e. nasoscopes, e.g. testing of patency of Eustachian tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/267Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the respiratory tract, e.g. laryngoscopes, bronchoscopes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/24Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks

Definitions

  • the present invention falls within the technical field of respiratory masks, and refers in particular to a nasal protection mask that reduces the exposure of healthcare personnel to aerosols and respiratory drops potentially transmitting pathogens such as COVID19 during manipulations.
  • a nasal protection mask that reduces the exposure of healthcare personnel to aerosols and respiratory drops potentially transmitting pathogens such as COVID19 during manipulations.
  • pathogens such as COVID19 during manipulations.
  • the nasal passages such as nasal endoscopies, bronchoscopies, endoscopic naso-sinus and anterior skull base surgeries or placement of nasogastric tubes.
  • pathogens such as SARS-CoV-2
  • SARS-CoV-2 The airborne transmission of pathogens such as SARS-CoV-2 is carried out mainly by respiratory droplets that are expelled both through the nose and the mouth.
  • pathogens such as SARS-CoV-2
  • the generation of aerosols with viral particles and their ability to remain in this state for up to 3 hours has also been demonstrated.
  • the object of the invention consists of a protective mask for nasal manipulation, temporarily and ergonomically attachable on the nasal area of a patient to create a partially closed and sealed midface chamber over the nose.
  • the mask can be connected to an external element for continuous aspiration, thus reducing the exposure of healthcare personnel to aerosols and potentially transmitting respiratory droplets during manipulations in the nasal passages, such as nasal endoscopies, bronchoscopies, sinus-sinus endoscopic surgeries and of anterior skull base or placement of nasogastric tubes.
  • the mask creates a chamber around the patient's nose, the interior of which can be accessed through a first opening defined in an anterior face of the mask body, designed to, in use, face the anatomical location of the fossae nasal, space through which an endoscope and surgical instruments can be inserted.
  • a second opening is located in an upper sector of the mask, in this case a through hole with dimensions smaller than those of the first opening, in which a connector for coupling a tube belonging to the aforementioned element is located. external continuous suction.
  • a negative pressure flow is generated inside the chamber that causes aspiration and suction of all aerosols that may be generated during endoscopic examinations or surgery, which are evacuated to the outside of the the camera.
  • This evacuation preferably takes place towards a vacuum suction tank, which must contain a dilution of bleach to deactivate the potential viruses contained in the flow evacuated from inside the mask.
  • said chamber is delimited on the perimeter, in the area that is in direct contact with the nasal area, with an edge of ergonomic geometry, which makes the mask support and adjust to the contour of the central-facial area completely covering the nose. It is envisaged that this edge is also covered by a soft cushion that comes into contact with the patient's face and facilitates the adaptation of the mask to the different facial contours.
  • This cushion is preferably made of a soft, elastic elastomeric material, such as soft silicone or the like.
  • the mask also has additional elements to correctly position, maintain and / or secure the mask on the patient's head.
  • the mask is secured to the patient's head by means of straps, elastic bands or similar devices, attachable to elements in the form of a handle, projecting from an external face of the mask.
  • a harness is thus formed that can be adjusted to assist in obtaining a tight seal with the face.
  • the first opening of the mask, through which the endoscopic material is introduced, must be covered at least partially in such a way as to create a seal as tight as possible to said opening, without compromising the necessary displacement capacity that it must have. the material.
  • the mask incorporates a thin elastic valve cover that allows the manipulation of multiple tools simultaneously.
  • Said cover is attachable in a perimeter housing located in the first opening.
  • the material used for this cover is thermoelastic elastomer, a flexible single-use material that allows the cover to be obtained by 3D stereolithography (SLA) printing.
  • the cover has a central valve made up of three leaflets, which allows the introduction of instruments into the nostrils, while preventing the exit of drops or aerosols when the instruments are not inserted.
  • the walls of the valve being of a very reduced thickness (a thickness of 1mm or less is expected) and being made of flexible material, allow the leaflets not to interfere with the movement of the instruments in the opening.
  • the seal of the first opening obtained with this cover is not totally hermetic when an endoscope and surgical tools are inserted into the nasal cavity.
  • the negative pressure inside the mask sucks up and removes the aerosols and gases created during surgery.
  • the covering is formed by engaging said grease with a surgical glove to which a through hole is made, which creates a hermetic seal when used with an endoscope. , be it rigid or flexible. It is an easy solution with a commonly available material that prevents aerosols and drops from spreading on an awake patient, making this embodiment especially applicable in the office.
  • the mask thus described is achievable by 3D additive printing, using biocompatible materials such as medical grade resins. Thanks to this material, the mask is sterilizable and therefore reusable, and is a simple, economical and versatile solution to provide rhinologists, pulmonologists and other professionals in the field of otorhinolaryngology and related, with the necessary protection against the transmission of airborne pathogens such as SARS-CoV-2.
  • Figure 1.- Shows a front top perspective view of a first embodiment of the mask.
  • Figure 2.- Shows a rear top perspective view of the mask.
  • Figure 3. Shows a rear bottom perspective view of the mask.
  • Figure 4 shows a bottom view of the mask.
  • Figure 5. Shows a first perspective view of a second embodiment of the mask in use.
  • Figure 6.- Shows a second perspective view of the second embodiment of the mask in use.
  • the protection mask for nasal manipulation that is described, shown in the attached figures, is made up of a hollow envelope (1), which defines on its internal face a chamber (2) intended to house the mid-facial anatomical area of a patient .
  • the chamber (2) is peripherally delimited by an adjustment edge (3) intended to rest on the patient's face. Therefore, said adjustment edge (3) has a curved and ergonomic geometry, configured to provide an adequate fit with the contour of the central-facial area and completely covering the nose.
  • the adjustment edge (3) is furthermore at least partially covered by a soft cushion (4) that facilitates the adaptation of the mask and improves the comfort of the patient.
  • the hollow casing (1) has a first opening (5) and a second opening (6) through, which connect the inside of the chamber (2) with the outside.
  • the first opening (5) has high dimensions and is located in a front sector of the external face of the hollow envelope (1), so that, in use, it is confronted with the anatomical location of the patient's nostrils, allowing insertion of surgical instruments.
  • this first opening (5) also comprises a perimeter housing (7), shaped like a fat, oriented towards the outside of the hollow casing (1).
  • the second opening (6) is located in this preferred embodiment in an upper sector of the hollow casing (1), and comprises a tubular connector element (8) to facilitate the coupling of a connecting tube (9) with an external continuous suction element, as shown in figures 5 and 6.
  • the hollow casing (1) also comprises elements of connection (10) with the anatomy of the patient, configured to correctly position and keep the mask secured on the head.
  • the joining elements (10) consist of respective lugs located at two opposite ends of the external face of the hollow casing (1), in which adjustable elastic bands are inserted with the patient's head, forming in this way a harness that collaborates to obtain a hermetic and comfortable closure of the mask with the face.
  • the first opening (5) of the hollow casing (1) must be covered by an elastic closure element (11), configured to create a seal that is as hermetic as possible, and at the same time allow the introduction and handling of surgical instruments as necessary displacement capacity that the material must have.
  • the elastic closure element (11) is formed by a thin elastic valve cover that can be attached to the perimeter greasing (7) of the first opening (5).
  • the cover It has a central valve made up of three lateral leaflets.
  • the elastic closure element (12) is made up of a perforated surgical glove, coupled by its wrist strap on the perimeter housing (7) of the first opening (5).

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Otolaryngology (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Optics & Photonics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Pathology (AREA)
  • Pulmonology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Textile Engineering (AREA)
  • Physiology (AREA)
  • Dentistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Ophthalmology & Optometry (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)

Abstract

La présente invention se rapporte à un masque de protection nasale permettant de réduire l'exposition du personnel sanitaire aux aérosols pendant la réalisation de manipulations dans les fosses nasales, telles que des endoscopies nasales, des bronchoscopies, des chirurgies endoscopiques naso-sinusales et de la base crânienne antérieure ou la mise en place de sondes naso-gastriques.
PCT/ES2021/070275 2020-04-30 2021-04-26 Masque de protection pour la manipulation nasale WO2021219912A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ESU202030765 2020-04-30
ES202030765U ES1247959Y (es) 2020-04-30 2020-04-30 Mascara de proteccion para manipulacion nasal

Publications (1)

Publication Number Publication Date
WO2021219912A1 true WO2021219912A1 (fr) 2021-11-04

Family

ID=71080014

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/ES2021/070275 WO2021219912A1 (fr) 2020-04-30 2021-04-26 Masque de protection pour la manipulation nasale

Country Status (2)

Country Link
ES (1) ES1247959Y (fr)
WO (1) WO2021219912A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2332375A (en) * 1997-12-22 1999-06-23 Ian James Broome Multi-port mask
US20120266885A1 (en) * 2009-12-24 2012-10-25 Giovanni Guglielmo Landoni Non-invasive ventilation mask and use thereof
US20120285455A1 (en) * 2011-05-11 2012-11-15 Varga Christopher M Smart connections
US20200100657A1 (en) * 2017-05-24 2020-04-02 Chonbuk National University Hospital Protection cover for nose endoscopy
US20200114178A1 (en) * 2013-09-04 2020-04-16 Waterford Mask Systems Inc. Facemask with filter insert for protection against airborne pathogens

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2332375A (en) * 1997-12-22 1999-06-23 Ian James Broome Multi-port mask
US20120266885A1 (en) * 2009-12-24 2012-10-25 Giovanni Guglielmo Landoni Non-invasive ventilation mask and use thereof
US20120285455A1 (en) * 2011-05-11 2012-11-15 Varga Christopher M Smart connections
US20200114178A1 (en) * 2013-09-04 2020-04-16 Waterford Mask Systems Inc. Facemask with filter insert for protection against airborne pathogens
US20200100657A1 (en) * 2017-05-24 2020-04-02 Chonbuk National University Hospital Protection cover for nose endoscopy

Also Published As

Publication number Publication date
ES1247959Y (es) 2020-09-07
ES1247959U (es) 2020-06-17

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