BR102021016551B1 - FULL FACE MASK FOR NON-INVASIVE BREATHING SUPPORT WITH POSITIVE PRESSURE - Google Patents

Abstract

FULL FACE MASK FOR NON-INVASIVE BREATHING SUPPORT WITH POSITIVE PRESSURE. Non-invasive ventilation (NIV) is a method that consists of applying positive pressure to the respiratory system through a mask or other interfaces. In the state of the art, NIV can be applied in some ways, through: microprocessed invasive ventilators of the Intensive Care Unit (ICU) with specific programs for this purpose (NIV mode) which must be coupled to nasofacial interfaces through elbow and circuit double of the mechanical ventilator itself; portable ventilators (flow generator, Bilevel), specific for this purpose with leak compensation, which must be coupled to nasofacial interfaces with a single circuit and exhalation valve located on the mask itself, and also the CPAP (Continuous Positive Airway Pressure) mode that can be applied through the medical gas network (high flow of oxygen and compressed air) (wall-mounted CPAP). However, for each possibility of NIV application, there is a specific interface for each situation. Within this context, the need arose to invent new multifunctional equipment (full face mask) addressing the three possibilities (microprocessed invasive ICU ventilators, portable ventilators or flow generator and through the medical gas network - high flow of (...) .

Description

field of invention

[001] The present invention comprises a full face mask for non-invasive respiratory support with positive pressure, whose main purpose is the treatment of patients with severe or not severe complications in the respiratory system, assisted by electromedical equipment. The present invention is in the field of clinical mechanical engineering.

Background of the invention

[002] Non-invasive ventilation (NIV) is a method that consists of applying positive pressure to the respiratory system, through a mask or other interfaces. The use of non-invasive methods has increased significantly in recent decades and NIV has become an essential tool in the management of acute and chronic respiratory failure (ARF) in a variety of etiologies, including the respiratory failure of COVID-19 (caused by the new coronavirus ). Despite all its importance in the treatment of respiratory failure, NIV has failure rates that can be considered high, ranging from 40 to 60% (SCHETTINO, G.; ALTOBELLI, N.; KACMAREK, R. M. Noninvasive positive-pressure ventilation in acute respiratory failure outside clinical trials: experience at the Massachusetts General Hospital. Crit Care Med., v. 36, n. 2, p: 441-7, 2008.).

[003] Problems related to the full face mask (FTM) interface are the most frequent adverse effects, accounting for 50-100% of all complications associated with NIV (MEHTA, S.; HILL, N. S. Noninvasive ventilation. Am J Respir Crit Care Med., v. 163, n.2, p: 540-77, 2001.). In addition, 25-33% of properly screened patients have NIV maladaptation or intolerance, primarily due to mask-related issues. Such problems include: excessive leaks, excessive air pressure on the face, claustrophobia, carbon dioxide (CO2) re-inhalation, nose skin lesions, facial pain and oronasal dryness. , A.; FOSTER, J.; HAGER, J.; MOREHOUSE, T.; WATTS, P.; WEEMS, L.; KOLLEF, M. Pressure Ulcer Incidence in Patients Wearing Nasal-Oral Versus Full-Face Noninvasive Ventilation Masks. Am J Crit Care., v. 24, n. 4, p: 349-56, 2015.; BLACK, J.; ALVES, P.; BRINDLE, C. T.; DEALEY, C.; SANTAMARIA, N.; CALL, E .; et al. Use of wound dressings to enhance prevention of pressure ulcers caused by medical devices. Int Wound J., v. 12, n. 3, p: 322-7, 2015.).

[004] In the state of the art, NIV can be applied in some ways, through: microprocessed invasive ventilators of the Intensive Care Unit (ICU) with specific programs for this purpose (NIV mode) which must be coupled to nasofacial interfaces through elbow and double circuit of the mechanical ventilator itself; portable ventilators (flow generator, Bilevel), specific for this purpose with leak compensation, which must be coupled to nasofacial interfaces with a single circuit and exhalation valve located on the mask itself, and also the CPAP (Continuous Positive Airway Pressure) mode that can be applied through the medical gas network (high flow oxygen and compressed air) (“wall” CPAP). However, for each possibility of NIV application, there is a specific interface for each situation.

[005] Within this context, the need arose to develop new multifunctional equipment addressing the three possibilities (microprocessed invasive ICU ventilators, portable ventilators or flow generator and through the medical gas network - high flow of oxygen and compressed air) of application of NIV, because for each possibility of NIV application there is a specific interface. In this way, NIV can be a strategy to avoid orotracheal intubation (OTI) and its complications, reducing hospitalization time, in addition to supplying the demand of hospitals for mechanical respirators.

[006] Considering the current scenario of high demand for respiratory pathologies that require non-invasive ventilatory support, such as the COVID-19 pandemic, health systems around the world face the challenge of reorganizing themselves to meet the demands imposed by the pandemic , including the high demand and consumption of health materials and supplies.

[007] It should be noted that the patents MU8900877-4U2 Respiratory Mask (Similarity: none; Difference: Utility for respiratory protection), BR102018072924-1A2 Respiratory Mask (Similarity: none; Difference: Respiratory mask adapted to cover the user's mouth and nose), BR112020019387-9 Breathing Mask (Similarity: none; Difference: Breathing mask and retention liner. The purpose of this liner is to facilitate the adaptation and improve comfort. It is an accessory to be used together with different types of mask, whether for protection or treatment. It is worth noting, however, that such an accessory is not compatible with the equipment presented here, as it is intended for oronasal models), WO2014/120597A2 Respiratory Mask (Similarity: none; Differences : Respiratory protection oronasal mask with adapted filters), WO2015/168077A8 Filtering Face Respirator (Similarities: none; Differences: Face mask with filter Respiratory Protection Filter), WO2019/164925A1 Breath Sampling Mask And System (Similarities: none; Differences: Breathing mask with sensor system. Cannot be used with high-flow oxygen therapy), US2018/0207386 Capnoxygen Masks (Similarities: none; Difference: Nasal mask for administering oxygen and measuring capnography. Cannot be used to administer positive pressure), WO2010/064826A2 Mask (Similarities : none; Differences: Mask for oronasal respiratory protection), US2014/0261431A1 Positive Pressure Respiratory Mask Mask (Similarity: respiratory mask; Difference: oronasal type mask; cannot be used with high-flow oxygen therapy), US2010/0043800A1 Nasal Respiratory Mask (Similarity: positive pressure mask; Difference: positive pressure nasal type mask; no can be used to administer high flow oxygen therapy), US2020/0156745A Full Face Mask (Similarity: full face mask the one; Differences: Cannot be used to administer high-flow oxygen therapy), US2020/0130972 Full Face Diving Mask (Similarity: Full face mask used for diving; Differences: Cannot be used to administer high-flow oxygen therapy) and WO2016/119006A1 Ventilation Mask (Similarity: Interface used to administer positive pressure to the patient; Differences: oronasal-type mask; cannot be used with high-flow oxygen therapy).

[008] Patent numbers US2014/0261431A1, WO2008/153755A1, US2010/0043800A1, US2020/0156745A, US2020/0130972 and WO2016/119006A1 are similar to the technology of the proposed equipment, which consists of providing respiratory support by positive pressure in situations of insufficiency breathing. However, the difference lies in the viability of the three possibilities of NIV application (microprocessed invasive ICU ventilators, portable ventilators or flow generator and through medical gases with high flow of oxygen and compressed air) in the same interface, due to the multiple connections allowed by the proposed invention, expanding the healing capacity compared to the state of the art, in addition to being a full face type interface. In the current scenario, considering the high rate of contagion of COVID-19, high-flow oxygen therapy is highly relevant for the prompt recovery of patients.

[009] Due to the size and shape of the proposed equipment, the amount of medicinal gases required for the use of oxygen therapy will possibly be smaller and this will impact the economy of medicinal gases (oxygen and compressed air), in view of the current health crisis in high demand and consumption of these inputs.

[010] The proposed invention differs from the adaptation of NIV through three possibilities (microprocessed invasive ICU ventilators, portable ventilators or flow generator and through the medical gas network - high flow of oxygen and compressed air), this gives autonomy to the equipment, allows its use in the most diverse hospital environments (ICU, wards or emergencies), enables the expansion of possibilities of use according to the material available in each hospital unit, be it an ICU ventilator, flow generator (Bilevel) or even same flow of medical gases, and can even dispense with the use of costly medical materials, such as mechanical ventilators.

[011] The present invention, in addition to providing functional improvements to products that already exist in the state of the art, solves the problems of lack of materials and high consumption of medical gases, as it allows the use in the most diverse hospital environments and the amount of medical gases necessary for the use of this equipment can be considered low, which will possibly impact the economy of medical gases (oxygen and compressed air). In addition, it presents easy handling, safety and comfort to the patient, due to the size and format of the proposed interface.

[012] The use of a non-invasive artificial respiration mechanism with positive pressure, in addition to reducing the demand for mechanical ventilators, stands out as an advantage, that is, the patient does not need to be intubated, avoiding the harmful consequences of this invasive technique.

[013] It is important to note that according to estimates by health professionals who used devices similar to the technology in other countries, the equipment would reduce the progression of patients' breathing difficulties by up to 60%, reducing the length of hospital stay and the need for access to the ICU, which demonstrates the feasibility and need for the application of technology in the fight against COVID-19, as well as for the treatment of any diseases that require non-invasive ventilatory support in a wide clinical applicability, both in the pandemic and in other health situations ( CABRINI; LANDONI; ZANGRILLO, 2020).

[014] The full face mask will be intended for patients of mild and intermediate severity and may prevent many cases from evolving to a level of complexity that requires a mechanical respirator.

[015] In addition, said invention brings commercial advantages, since it ensures simplicity in its production and maintenance, which, consequently, makes its cost of sales less expensive than those currently existing and exploited.

[016] In order for the proposed invention to be understandable, to be applied in practice by a technician with expertise in this technological and health area, the invention will be explained below, based on the drawings presented, illustrating the full face mask for support non-invasive breathing with positive pressure.

[017] The present invention has an innovative geometry with a clear evolution of conventional CPAP masks, adding features of separation of exhalation and inhalation flows. In order to offer innovation in mobility and ergonomics not yet found in assisted breathing devices aimed at treating COVID-19, it offers a series of advantages and improvements for patients and health teams in non-invasive ventilatory support.

[018] Figure 1 shows an exploded isometric view of the equipment, identifying its components.

[019] Figures 2A and 2B show two isometric views of the assembled equipment, showing the front and back, identifying its components.

[020] Figures 3A-3C show the 3 main orthogonal views of the assembled equipment (front, top and side), identifying its components.

[021] Figure 4 shows a view and a section of the assembled equipment, identifying its components.

[022] The invention is composed of 6 parts as named: SHIELD (01), CUSHION (02), ARC (03), INSPIRATION VALVE (04), EXPIRATION VALVE (05), EXPIRATION COVER (06).

[023] THE SHIELD (01) is a piece of rigid and translucent material with geometry obtained by injection process in thermoplastic mold. The piece has an ergonomic adjustment to accommodate the nose and two holes for external communication. THE UPPER ORIFICE (01.1) has geometry and dimensions for fitting the INSPIRATION VALVE (04), while the LOWER ORIFICE (01.2) has geometry and dimensions for tight fitting the EXPIRATION VALVE (05). In its perimeter, the SHIELD (01) has a channel, open on one side and with direct communication with the TOP ORIFICE (01.1).

[024] THE CUSHION (02) is a piece made of rubberized material with geometry obtained by injection process in thermoplastic mold. The part is in direct contact with the SHIELD (01), having with it a complementary fit to its perimeter channel, creating a duct that has openings only in the TOP ORIFICE (01.1) and in the area closest to the chin. This duct is responsible for conducting the incoming flow of gases directly to the patient's oronasal region, preventing dryness of the eyes. THE CUSHION (02) is also responsible for direct contact with the patient's face, distributing the pressure throughout the contour of the face, from the forehead, resting on the cheekbones, to the chin. In this way, it allows the equipment to be pressed against the patient's face with sufficient intensity to maintain the necessary pressures for the various non-invasive respiratory therapies while mitigating the discomfort caused by such pressure.

[025] The ARCH (03) is a piece made of rigid and opaque material, being responsible for, through its fitting in the external part of the CUSHION (02), pressing it against the perimeter of the SHIELD (01), performing the first equipment seal. On its perimeter, you can also find straps arranged on the sides: two in the area near the temple, two in the area near the chin. Its design and dimensions are designed to fit a cephalic strap (harness) commonly found on the market.

[026] THE INSPIRATION VALVE (04) is an “L” shaped duct, made of rigid material, with openings at both ends. One of them has geometry and dimensions for a tight fit with the TOP HOLE (01.1) of the SHIELD (01). The other has geometry and dimensions to fit a hospital Hight Efficiency Particulate Air (HEPA) bacterial filter, as well as for connection to a corrugated silicone trachea. It also has an extra outlet with two diameters. The largest corresponds to the diameter needed to fit an oxygen catheter, necessary in some respiratory therapies. The smaller one corresponds to the diameter required to fit the pressure measurement point (necessary for the operation of some ICU ventilators). This extra outlet is sealed by a lid in rubberized material that is fixed to the part itself, allowing its use only when necessary.

[027] THE EXPIRATION VALVE (05) is an “L” shaped duct, made of rigid material, with openings at both ends. One of them has geometry and dimensions for a tight fit with the LOWER HOLE (01.2) of the SHIELD (01). The other has geometry and dimensions to fit a hospital HEPA bacterial filter, as well as to connect to a corrugated silicone trachea. Attached to this end we have the EXPIRATION COVER (06), made of the same material as the valve and responsible for the possibility of closing it, allowing the use of the equipment in respiratory therapies that use only one branch of communication with the mechanical ventilator. EXPIRATION VALVE (05) and EXPIRATION COVER (06) are connected to each other by means of a piece made of flexible material, making it difficult to lose the removable part when it is not in use. THE EXPIRATION VALVE (05) also has an extra outlet, located in its lower part, acting as an exhalation valve, necessary in some respiratory therapies. This extra outlet is sealed by a cover made of rubberized material that is attached to the part itself, allowing its use only when necessary.

[028] Composed of the aforementioned parts, the equipment promotes isolation between the patient's face and the external environment, allowing pressure control in the space between the ESCUDO (01) and the face. Such pressure is guaranteed by the fit between the CUSHION (02) and the face and is controlled by the inspiratory and expiratory flows, for which the INSPIRATION VALVE (04) and the EXPIRATION VALVE (05) are responsible, respectively. The inspiratory flow is conducted inside the mask through a duct formed between the SHIELD (01) and the CUSHION (02), on the perimeter of the first one, being released in the area close to the chin. In the expiratory flow, the LOWER ORIFICE (01.2) connects the area between the SHIELD (01) and the patient's face directly with the EXPIRATION VALVE (05).

[029] It is important to emphasize that the proposed invention is easy to handle and apply, which provides speed in procedures and more urgent cases, without causing discomfort or putting the patient and health professionals at risk.

Claims (10)

1. Full face mask for non-invasive respiratory support with positive pressure comprising a shield (01), a cushion (02) and an arch (03), wherein the shield (01), the cushion (02) and the arch (03 ) are adapted to fit together to form the face mask, characterized in that: the face mask comprises, in its upper part, a first hole (01.1) adapted for fitting with an inspiration valve (04) and a second hole ( 01.2) adapted for fitting with an exhalation valve (05); and a duct is formed between the shield (01) and the pad (02), the duct comprising an inlet connected to the first hole (01.1) and an outlet at the lower inner part of the mask and running around the perimeter of the mask between the inlet and the duct outlet. 2. Mask, according to claim 1, characterized by the fact that the shield (01) is made of rigid and translucent material. 3. Mask, according to claim 1 or 2, characterized by the fact that the cushion (02) is made of rubberized material. 4. Mask according to any one of claims 1 to 3, characterized in that the bow (03) is made of rigid and opaque material. 5. Mask according to any one of claims 1 to 4, characterized in that the bow (03) comprises handles adapted to fit a cephalic strap. 6. Mask, according to any one of claims 1 to 5, characterized in that it comprises the inspiration valve (04). 7. Mask, according to claim 6, characterized in that the inspiration valve (04) comprises: a first opening at a first end adapted to fit with the first hole (01.1); a second opening at a second end adapted for engagement with a breathing device; and, preferably, a third opening adapted to fit oxygen delivery and/or pressure measuring devices. 8. Mask, according to any one of claims 1 to 7, characterized in that it comprises the exhalation valve (05). 9. Mask, according to claim 8, characterized by the fact that the exhalation valve (05) comprises: a first opening at a first end adapted to fit with the second hole (01.2); a second opening at a second end adapted for engagement with a breathing device; and, preferably, a third aperture. 10. Mask according to any one of claims 6 to 9, characterized in that the second and third openings of the inspiration valves (04) and expiration valves (5) can be sealed by a lid.

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