WO2021219912A1

WO2021219912A1 - Protective mask for nasal manipulation

Info

Publication number: WO2021219912A1
Application number: PCT/ES2021/070275
Authority: WO
Inventors: Jaime Viera Artiles; Jose Julián VALDIANDE GUTIÉRREZ; Jose Miguel LÓPEZ HIGUERA
Original assignee: Servicio Cántabro De Salud; Universidad De Cantabria
Priority date: 2020-04-30
Filing date: 2021-04-26
Publication date: 2021-11-04
Also published as: ES1247959U; ES1247959Y

Abstract

The present invention relates to a nasal protection mask for reducing health workers' exposure to aerosols when carrying out manipulations in the nostrils, such as nasal endoscopies, bronchoscopies, nasal and sinus endoscopic surgery, anterior skull base endoscopic surgery or nasogastric probe insertion.

Description

DESCRIPTION

Protection mask for nasal manipulation.

OBJECT OF THE INVENTION

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. in the nasal passages, such as nasal endoscopies, bronchoscopies, endoscopic naso-sinus and anterior skull base surgeries or placement of nasogastric tubes.

BACKGROUND OF THE INVENTION

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. However, the generation of aerosols with viral particles and their ability to remain in this state for up to 3 hours has also been demonstrated.

Healthcare personnel protection systems against COVID-19 are constantly evolving, and the field of otorhinolaryngology is no exception, with growing concern among rhinologists due to possible exposures to high viral load reservoirs during endoscopic procedures in the nasal cavity and nasopharynx. The viral load in the nasal epithelium is higher than in the rest of the respiratory tract, and that is why otorhinolaryngologists are a type of specialist especially exposed to this virus.

In addition, it has recently been shown that endoscopic anterior skull base and nasal surgery generates aerosols, which as noted above may contain viral particles and potentially expose operating room personnel to infection.

Several international reports have emphasized the importance of taking extra precautions to safely perform rhinological procedures and examinations, for both clinicians and patients, even when patients are asymptomatic. Therefore, it is imperative to identify alternatives to mitigate this risk for rhinology personnel. Following the demonstration of aerosolization during endoscopic surgeries, emergency solutions have been proposed such as fitting surgical masks with glove fingers for endoscopic nasal examinations. However, it is not a feasible solution for long-term surgeries in which not only the endoscope is inserted through the nose, but more instruments are used and they have to be removed and reinserted on numerous occasions. Thus, there is no system that is specifically geared towards eliminating aerosols during these types of procedures.

Individual protection systems are based more on a mask-type barrier mechanism with particle filters or full face masks. These systems do not prevent the spread of the virus and its subsequent deposition on surfaces. In addition, each person exposed to an operating room must wear one and not just the surgeon.

Therefore, there is a need for specific protection elements to avoid the transmission of pathogens by aerosolization during endonasal examinations and interventions.

DESCRIPTION OF THE INVENTION

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. Thus, through said second opening 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.

To ensure both the adequate sealing of the chamber and the comfort of the patient, 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. In a preferred embodiment, 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.

In a first preferred embodiment, for this covering of the first opening, 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. In its preferred embodiment, 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. However, the negative pressure inside the mask sucks up and removes the aerosols and gases created during surgery.

In a second preferred embodiment, since the first opening comprises a perimeter grease, 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.

However, endoscopic surgeries are more dynamic settings where multiple instruments are often required. The glove in these cases can tear when changing instruments and not be an effective protection.

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.

DESCRIPTION OF THE DRAWINGS

To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, according to a preferred example of practical realization of the same, a set of drawings where, with an illustrative and non-limiting nature, the following has been represented:

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.

PREFERRED EMBODIMENT OF THE INVENTION

A detailed explanation of a preferred embodiment of the object of the present invention is provided below, with the aid of the aforementioned figures.

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. As can be seen in the figures, 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), with dimensions smaller than those of the first opening (5), 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.

Thus, through said second opening (6) a negative pressure flow is generated inside the chamber (2), which causes a suction and suction of all the aerosols that can be generated, which are evacuated to the outside from the chamber (2), to the external suction element.

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.

In these preferred embodiments, 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.

In the first preferred embodiment of the mask, shown in Figures 1-4, 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). In this embodiment, the cover It has a central valve made up of three lateral leaflets.

In the second preferred embodiment of the mask, shown in use in Figures 5 and 6, 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).

Claims

1. Protection mask for nasal manipulation, to reduce the exposure of healthcare personnel to aerosols during manipulations in the nasal passages, such as nasal endoscopies, bronchoscopies, endoscopic sinus and anterior skull base surgeries or placement of nasogastric tubes, characterized by comprising:

- A hollow envelope (1), which defines on its internal face a chamber (2) delimited perimeter by an adjusting edge (3) for housing the mid-facial anatomical area of a patient, hollow envelope (1) comprising:

- a first through opening (5), for inserting surgical instruments into the chamber (2) and which in turn comprises a perimeter housing (7) facing the outside of the hollow casing (1);

- a second opening (6) comprising a connector element (8) for coupling a connecting tube (9) with an external continuous suction element, and

- some joining elements (10), configured to correctly position and keep the mask secured on the patient's head; and

- An elastic closure element (11) connectable with the first opening (5) of the hollow casing (1) and configured to create a possible hermetic seal compatible with the introduction and handling of surgical instruments through the first opening (5 ).

Protection mask according to claim 1, characterized in that the elastic closure element (11) is a thin elastic valve cover that can be coupled to the perimeter housing (7) of the first opening (5).

Protective mask according to claim 1, characterized in that the elastic closure element (11) is a perforated surgical glove, coupled by its wrist strap to the perimeter housing (7) of the first opening (5).

Protective mask according to any of the preceding claims, characterized in that the adjustment edge (3) has a curved geometry to fit the contour of the central-facial area and covering the nose.

Protective mask according to any of the preceding claims, characterized in that the adjustment edge (3) incorporates a soft cushion covering (4).

Protective mask according to any of the preceding claims, characterized in that the joining elements (10) comprise:

- some lugs located at two opposite ends of the external face of the hollow casing (1), and

- adjustable elastic bands that can be inserted into the ears and can be attached to the patient's head.

Protection mask according to any of the preceding claims, characterized in that the hollow shell (1) is made by 3D additive printing.

8. Protective mask according to claim 7, characterized in that the hollow shell (1) is made of a medical grade resin.