TR2025003263A2 - A FACE MASK - Google Patents

Abstract

The invention is a contact section that includes the entire face, namely the mouth and nose, in a form that includes the frontal area above the eyebrows in front, the zygomatic, buccal and mental areas in the lower middle and is similar to the structure of the face that touches the face; an outer section (1.2) that completely covers the face, including at least one visual area (1.1.1) that provides the patient's vision, and an inner section (1.2) that includes the mouth and nose but does not include the eyes and is in a form that includes the infraorbital, buccal and mental areas from the front of the nose to the top, from the sides to the top, from the right and left, not including the orbital area; It also concerns a face mask comprising at least one nasal cuff and pilot balloon (1.2.1) which can be inflated in the parts in contact with the nose, which when inflated and when the inhaled agent is to be administered ensures that the gel pressure in the inner part (1.2) is lifted or relieved or conversely when deflated ensures that the gel in the inner part (1.2) fits the face and also prevents the inhaled agent from reaching the eyes when inflated, and at least one inhaler inlet (1.2.2) which has an opening structure that enables the inhaled agent to be administered to the patient after the said nasal cuff and pilot balloon (1.2.1) are inflated, i.e. comprising the said convex inner part (1.2) used when the inhaled agent is to be administered to the patient and at least one cushion in the parts in contact with the skin, and further comprising the said concave outer part (1.1) used when non-invasive mechanical ventilation (NIV) is applied.

Description

DESCRIPTION A FACE MASK Technical Field The invention is a face mask developed to improve morbidity and mortality in patients with respiratory distress through noninvasive mechanical ventilation. State of the Art The literature on airway management focuses predominantly on tracheal intubation, the use of supraglottic airway devices (SADs), and front-of-neck access. However, face mask ventilation is arguably the most fundamental skill in airway management. Face mask ventilation has been accepted as a method of ventilation for noninvasive positive pressure ventilation (NPPV) or noninvasive ventilation (NIV). In cases of respiratory failure due to COPD exacerbations and in patients with COVID-19, ventilating with a face mask, without intubation or ventilator, has improved survival. When face masks are used appropriately, NIV improves patient comfort, provides convenience, reduces morbidity, avoids the complications of invasive (intubation) ventilation, and reduces medical care costs. Face mask ventilation can serve as a primary technique for inhalational anesthesia and oxygenation, as well as a rescue oxygenation technique. Its use can be essential to avoid serious morbidity or mortality in difficult airway management scenarios. Capnography should be used during ventilation to provide an objective assessment of effectiveness. In this sense, face masks used in the current state of the art, when used to support breathing, cause varying degrees of damage to different parts of the face, including the skin and subcutaneous tissue, and even the bone structure. It is necessary to anatomically identify the damaged skin or areas of skin where damage has occurred. It is also necessary to determine the degree of skin damage. This distinction is necessary because the damaged area and degree of damage will vary depending on the type of mask used. Currently, there are four types of masks commonly used for Non-Invasive Positive Pressure Ventilation (NIV): nasal masks, mouthpieces, oronasal masks, and headstrap masks. These masks have their own advantages and disadvantages. Nasal masks are the most commonly used type of masks in the state of the art. These masks offer a non-invasive solution for chronic respiratory failure. Nasal masks are commercially available in a variety of sizes and types. Standard nasal masks were originally developed for nasal continuous positive pressure delivery. The standard nasal mask consists of a triangular, clear plastic dome that fits over the nose and connects to the ventilator hose. A soft rubber or silicone seal contacts the skin, creating an air seal. Nasal masks are generally well tolerated, but a number of adverse side effects can occur, especially during initial use, as the patient adapts to the technique. The most common problem relates to discomfort at skin contact points and the tension required to control air leaks. Air leaking from the mouth during nasal ventilation with a nasal mask is a very common occurrence and can cause serious problems. Problems with nasal masks include discomfort, skin rashes, wounds on the bridge of the nose, injuries to various parts of the face, nasal congestion, and the inability to use the mask. Furthermore, in acute settings, another type of mask, oronasal masks, is also gaining popularity. However, problems with oronasal masks include discomfort, claustrophobia, skin rashes, wounds on the bridge of the nose, increased nasal surface area, and vomiting. Furthermore, discomfort, increased salivation, saliva retention, air swallowing, pressure sores on the lips, and orthodontic problems are the main problems with another type of mouthpiece mask. Although headband masks offer better comfort, they are not suitable for use. Recently, continuous positive airway pressure (CPAP) masks have been used as an alternative to these to treat obstructive sleep apnea. Furthermore, NIV masks are used in another known form of the technique, particularly in patients with kyphoscoliosis and neuromuscular diseases. Noninvasive Positive-Pressure Ventilation (NIV) devices, used in this known form of the technique, are accepted as a ventilator modality and are used in cases of respiratory failure due to exacerbations of COPD. While they are the first-line device for acute patients, they have also found widespread use in chronic respiratory failure disorders related to the chest wall or neuromuscular diseases. Survival rates for COVID-19 patients who are intubated and connected to a ventilator are reduced compared to those ventilated with a face mask. In other words, it is known that intubated patients have a higher mortality rate than those who wear a mask. When used appropriately, NIV devices improve patient outcomes, provide comfort and convenience, and reduce morbidity. They also avoid the complications of invasive ventilation and reduce medical care costs. NIV is generally safe and well-tolerated by most patients. However, NIV has also been shown to have negative side effects, with complications and failure rates ranging from 10% to 40% in published studies. The most common problems encountered during NIV use are related to the mask (or interface). When pressure is applied to the face for too long, it can cause ulceration on the bridge of the nose in up to 10% of patients. NIV can cause skin damage on the forehead and/or the bridge of the nose and/or bilateral cheeks and/or the anterior-middle part of the chin. On the other hand, in a known case of this technique, the face mask is used to prevent air from escaping from the inside to the outside by applying pressure to the face with belts attached to the mask, which does not properly grip the skin and causes air leakage. Furthermore, when it is necessary to administer inhaled (breath-reducing) medications to patients receiving NIV, the patient is advised to use NIV. Drugs are administered separately, causing the patient's oxygen level to decrease. In other words, inhaled drugs must be administered before the patient is separated from the NIV, and masks with this feature are rare. In addition, the inhaled medication administered during NIV application can cause irritation, allergies, and severe discomfort in the area covered by the mask, especially in the eyes. On the other hand, when patients using a face mask want to communicate with their surroundings, communication cannot be established. Communication is achieved by removing the patient's mask, which reduces oxygenation and causes distress. Therefore, although NIV is safe, its side effects still persist, and new types of NIV should be developed to minimize or eliminate these side effects. Brief Description of the Invention The purpose of the invention is to produce a face mask to improve morbidity and mortality in patients with respiratory distress through noninvasive mechanical ventilation. The invention aims to realize this. The face mask which is the subject of the invention consists of two parts: The first is the outer part which completely covers the face (or chamber, ring) and the second is the inner part which covers the nose and mouth (or chamber, ring). The invention aims to produce a face mask which is more effective, easy to use, preferable, can be used comfortably for a long time and does not cause air leakage, which minimizes or eliminates the effectiveness, usage difficulties, side effects of face masks used for non-invasive ventilation in patients, in other words, the damage they cause to the face, facial skin damage. In addition, the invention has produced a face mask which enables the administration of inhaled drugs without being separated from NIV. The mask has a structure which ensures that the inhaled drug given to the patient during NIV application does not cause irritation or allergy in the patient's eyes. On the other hand, the mask includes at least one speaking opening which allows patients to communicate with their environment when they want to communicate. In addition, the invention aims to produce a face mask which is in contact with the skin. The edge/contact surface structure is concave and this grips the skin well, meaning that the mask cheeks apply positive pressure inward on the skin due to the air escaping from the inside to the outside. Thus, the outer part of the mask adheres to the skin due to the venturi effect created by the escaping air. Thus, air leakage is prevented. Explanation of Figures Figure 1. This is a general representative view of the face mask, which is the subject of the invention, from the inside. Figure 2. This is a general representative view of the face mask, which is the subject of the invention, from the side during use. Figure 3. This is a representative drawing of the inner and outer edge/wall structures of the face mask, which is the subject of the invention, which have three leakage barriers and are in contact with the skin. Explanation of References in Figures For a better understanding of the invention, the corresponding numbers in the figures are given below: 1. Face mask 1.1. Outer section 1.1.1. Visual field 1.1.2. Speech aperture 1.1.3. Outer pillow 1.2. Inner section 1.2.1. Nasal cuff and pilot balloon 1.2.2. Infaler inlet 1.2.3. Exhalation outlet 1.2.4. Inner pillow 1.2.5. Balloon barrier GA. Gas flow trying to go out from inside Detailed Description of the Invention The face mask (1) which is the subject of the invention is a full face venturi mask. The face mask (1); includes an outer section (1.2) which is in a form that includes the part that covers the whole face, i.e. the mouth and nose, the frontal area on the muscles in the front, the zygomatic, buccal and mental areas in the lower middle, and also includes at least one nasal cuff and a pilot balloon (1.2.1) which can be inflated in the parts that contact the nose, and also includes the mouth and nose but not the eyes, and from the front to the top of the nose, It includes an inner section (1.2) in a form that includes the infraorbital, buccal and mental regions on the sides from top to bottom, on the right and left, without including the orbital area. The outer section (1.1) that completely covers the face includes at least one contact section in a form similar to the structure of the face that contacts the face; at least one visual field that provides the patient's vision (1.1.1); in the parts that contact the skin and in the ring/hook structure, it includes at least one outer cushion (1.1.3) that is curved outward and inward and allows the gas flow (GA) that flows from the inside to the outside or tries to escape, to open into the elastic hook/ring with the flow/pressure and to adhere to the skin and also acts as a third barrier by preventing gas leakage from inside to outside of the mask. The outer section (1.1) has a concave structure and thanks to this structure, it prevents the escaping air and skin It adheres to the skin with the pressing force. In addition, when patients using the face mask (1) want to communicate with their environment, the outer part (1. 1) includes at least one speech opening (1.1.2) that allows the patient to speak and communicate. The speech opening (1. 1.2) is positioned under the outer part (1. 1) in the preferred embodiment of the invention. In another embodiment of the invention, the speech opening (1.1.2) is positioned on the lower-side parts of the outer part (1.1) (Figure- 1). The inner part (1.2) is positioned inside the full face mask (1) so as to include the nose and mouth. After the nasal cuff and the pilot balloon (1.2.1) are inflated, the medication is administered to the patient by inhalation. The inner part (1.2) is opened and contains at least one inhalation opening. In order to ensure the administration of the medication, it contains at least one inhaler inlet (1.2.2) and at least one inner cushion (1.2.4) which is pressed on its curved elastic end and adhered to the skin by pressing the gas flow (GA) directed to the outside by the positive pressure inside the mask (1). It also contains a mask balloon barrier (1.2.5) which prevents the gas flow from inside to outside and acts as a second barrier. In other words, the gas flow (GA) trying to go out from inside tries to pass between the skin (C) and the said inner cushion (1.2.4) and thus the end bend of the inner cushion (1.2.4) presses/sticks to the skin (C) and prevents air escape. The inhaler inlet in question is shown on the side of the mask in Figure 1. (1.2.2) and the valve ensures that the inhaler medication goes into the inner compartment (1.2). When the inhaler agent is to be administered, the inhaler agent side is opened by turning the handle/valve (or valve) located outside the face mask (1). The incoming air vaporizes the nebules and is given to the space connected to the inner compartment (1.2), that is, the agent is inhaled through the nose. In addition, since the inner compartment (1.2) does not enter the eyes, the eyes are prevented from being affected by the inhaled agents, i.e., medications, administered to the respiratory tract. In other words, the inner compartment (1.2) only covers the nose and mouth, thus protecting the patient from possible toxic effects on the eyes. To prevent this, the inner compartment (1.2) of the inventive mask has been specially designed to include at least one nasal cuff and a pilot balloon (1.2.1). The inner compartment (1.2) also contains at least one exhalation vent, which is smaller than the standard mask and is made invisible. The outlet (1.2.3) contains at least one inspiratory valve that opens during inspiration and allows air to enter, and at least one expiratory valve that opens during expiration and allows air to be expelled. With this form of the face mask (1), the pressure created by the incoming fresh gas is adjusted and the adjusted PEEPain is expelled above it, improving the patient's oxygenation more effectively. The amount of fresh gas is adjusted to prevent rebreathing. In addition, the face mask (1) contains at least one hose for fresh gas inlet from the bottom and waste gas outlet from the bottom. The inner section (1.1) has a gel structure and is convex in shape. When the inhaler agent is to be administered, at least one nasal cuff and the pilot balloon (1.2.1) are inflated, (1.2) The gel pressure is lifted or relieved, or the opposite situation can be created. In other words, when at least one nasal cuff and pilot balloon (1.2.1) contained in the inner section (1.2) are deflated, the gel in the inner section (1.2) settles on the face. Thus, the nasal cuff and pilot balloon (1.2.1) in the inner section (1.2) reduce the pressure (or the pressure it creates) created by the face mask (1) on the face. Thus, the inner section (1.1) and the outer section (1.2) create pressure in the areas where they come into contact at certain times. Since the pressure applied to the contact areas is not constant, the face mask in question (1) is a mask that can be used for long periods. With long-term use of the face mask (1), damage, especially to the facial area, is reduced or no damage occurs. When non-invasive mechanical ventilation (NIV) is applied, the outer section (1.1) of the mask is used. Inhalation agent When the mask is to be administered, the inner part (1.2) of the mask, that is, the inner mask, is used. The nasal cuff and pilot balloon (1.2.1) are inflated, and the inhalation agent is administered to the patient. The inhalation agent reaches the respiratory tract through the mouth and nose, thus minimizing the toxic effect of the agent on the eyes or facial skin. A wide and double barrier is placed in areas where there is pressure on the face. In other areas, a single barrier and adhesive or closure is applied. The inner part (1.2) includes a double barrier, namely the inner cushion (1.2.4) and the balloon barrier (1.2.5), covering the nasal bones in the area from the nose dorsum to the forehead. As mentioned above, the inner cushion (1.2.4) is the gas flow directed to the outside by the positive pressure inside the mask (1). It adheres to the skin by pressing on its tip, preventing gas escape and acting as a primary barrier. The mask's balloon barrier (1.2.5), as mentioned above, is the secondary barrier that prevents gas from escaping from the inside out. In other words, the balloon barrier is located inside and completely covers the face from the outside. The gripper barrier is oriented from the inside out. The gripper barrier is flexible and is used to fill folds or depressions. The structure of the skin-contacting surfaces (side/outside) of the outer section (1.1) of the face mask (1) can be in various forms, including balloon/sticky, gel-like, concave, or springy. The face mask (1) of the invention, compared to the face mask used in the current technique, has a positive pressure relationship with the skin oriented from the inside out. Air leakage from the edges of the mask creates a venturi effect through the mask channels, ensuring the mask adheres to the scalp. Definitions: l) Positive cheek structure from outside inwards 2) Positive cheek structure from inside outwards In the second case, the internal pressure should push the cheek liners and adhere to the surface - with increasing positive pressure, the pressure exerted by the cheek on the skin increases, preventing leakage. Positive pressure is applied to the mask balloon/outer pillows, and when the pressure decreases, the cheek pressure also increases, preventing leakage, thus lowering the cheek pressure at low pressures. The face mask (l) includes at least one Bluetooth headset. Communication is provided by the addition of the Bluetooth headset. Operating mechanism of the mask: The face mask (l) is attached to the patient's face in a way that provides ventilation with normal pressure and is not tight, and ventilation is performed. Improvements have been made to prevent air leakage between the mask (1) and the skin, which is the subject of the invention. The inventive face mask (1) and its components have dynamic mechanisms to prevent air leakage when it occurs. These mechanisms detect air leakage and take precautions. The first measure is to block the area where the leak occurs; the second measure is to prevent leakage by increasing the pressure within at least one balloon. The second measure is used in the invention. The pressure exerted by the force increases due to the effect of air escaping between the skin and the contact area of the mask. The adhesive section at the end of the contact area pushes the protrusion or tab towards the skin, reducing air leakage between the skin and the mask. The decreasing pressure in the space between the mask and the skin is balanced by the shape of the inventive face mask (1). One path providing air flow to the mask is divided into two in the mask. The first pathway provides the air pressure inside the mask, that is, the space between the mask and the skin, while the second pathway provides the pressure in the mask bladder or cuff. When airflow passes rapidly or is restricted to the first pathway, it is automatically directed to the second pathway. The airflow closes the first pathway, travels through the second pathway, and inflates the mask balloon. In other words, when the pressure in the first pathway decreases, the airflow is directed to the second pathway. This pressure in the second pathway decreases. Therefore, when the air pressure in the space between the mask and the skin decreases, air flows from the first pathway, increasing the pressure in the second pathway, and the airflow is directed to the second pathway. Industrial Applicability of the Invention The invention relates to a face mask developed to improve morbidity and mortality in patients suffering from respiratory distress and is of industrial applicability. The invention is not limited to the above explanations; a person skilled in the art can easily identify different applications of the invention. These should be evaluated within the scope of the protection sought by the invention's claims.

Claims (1)

REQUESTS 1. The part that covers the entire face, that is, the mouth and nose, the frontal area above the muscles in the front, the zygomatic, buccal and mental areas in the lower middle, and at least one contact section in a form similar to the structure of the face that touches the face; an outer section that completely covers the face, including at least one visual area (1.1.1) that provides the patient's vision (1.2) and an inner section (1.2) that again covers the mouth and nose but does not include the eyes and is in a form that includes the infraorbital, buccal and mental areas from the front to the top of the nose, from the sides from top to bottom, on the right and left, but does not include the orbital area; In addition, at least one nasal cuff and pilot balloon (1.2.1) that can be inflated in the parts that contact the nose, that when inflated and when the inhaled agent is to be administered, allows the gel pressure in the inner section (1.2) to be lifted or relieved or, conversely, when deflated, allows the gel in the inner section (1.2) to settle on the face and also prevents the inhaled agent from reaching the eyes when inflated, and at least one inhaler inlet (1.2.2) with an opening structure that allows the inhaled agent to be administered to the patient after the nose cuff and pilot balloon (1.2.1) are inflated, that is, at least one inner cushion (1) that is used when the inhaled agent is to be administered to the patient and that is directed to the outside by the positive pressure in the mask (1) and is adhered to the skin by pressing its bent elastic end, that prevents gas escape and acts as a first barrier .2.4) and also comprising the mask balloon barrier (1.2) which prevents gas leakage from the inside to the outside and acts as a second barrier, and at least one outer cushion (1.1.3) in the parts in contact with the skin, and also characterised by said outer section (1.1) in a concave form used when applying non-invasive mechanical ventilation (NIV). A face mask (1) as in claim 1, characterised by comprising an outer cushion (1.1.3) which has a ring/hook structure, whose bend is outwards and inwards and which ensures that the gas flow (GA) flowing from the inside to the outside or trying to flow outwards enters the elastic hook/ring with the flow/pressure, opens and adheres to the skin, and also acts as a third barrier by preventing gas leakage from the inside to the outside of the mask (1). A face mask (1) as in claim 2, characterized by an inner section (1.2) comprising a double barrier, namely an inner pillow (1.2.4) and a balloon barrier (1.2.5) in a way that will include the bones in the nose, in the area from the bridge of the nose to the forehead. A face mask (1) as in claim 3, characterized by an inner section (1.2) comprising at least one exhalation outlet (1.2.3) which is smaller in size than the standard mask and is made invisible, at least one inspiratory valve which opens at the moment of inspiration and allows air to enter, and at least one expiratory valve which opens at the moment of expiration and allows air to be expelled. A face mask (1) as in claim 4, characterized by an outer section (1. 1) which adheres to the skin with the escaping air and the force pressing on the skin thanks to its concave structure. A face mask (1) as in claim 5, characterized by an outer section (1. 1) comprising at least one speech opening (1.1.2) enabling the patient to speak and communicate when they want to communicate with their environment. A face mask (1) as in claim 6, characterized by comprising a speech opening (1.1.2) positioned at the bottom or lower-side parts of the outer section (1.1). A face mask (1) as in any of the above claims, characterized by comprising an outer section (1. 1) whose structure of the surfaces in contact with the skin may be various forms such as balloon/sticky or gel-like or concave or springy. A face mask (1) as in any of the above claims, characterized by comprising at least one hose for fresh gas inlet from the bottom and exhaust gas outlet from the bottom. A face mask (1) as in any of the above claims, characterized by containing at least one balloon that prevents air leakage by increasing the pressure inside.