A multi-functional mask for non-invasive ventilation therapy

Abstract

The application discloses a multifunctional mask for noninvasive ventilation treatment, and belongs to the technical field of medical devices. The multifunctional mask comprises a mask main body, a headband and a mandibular lift module; the mask main body is used for covering the oral and nasal regions of a patient, the edge of the mask main body is provided with a sealing pad, and the upper portion of the mask main body is provided with a ventilation interface; the headband is used for fixing the mask main body to the head of the patient; the mandibular lift module is connected to the mask main body or the headband and is used for lifting the mandible of the patient forward and upward, and the mandibular lift module comprises a lifting piece, an adjustable support arm and a driving and locking mechanism; the lifting piece is matched with the lower edge of the mandible and the chin in shape and the inner surface of the lifting piece is provided with a buffer pad; the adjustable support arm is provided with at least one movable joint and / or a length adjusting mechanism; and the driving and locking mechanism is used for adjusting and locking the spatial position and the angle of the support arm. The multifunctional mask integrates the functions of noninvasive ventilation and mandibular lift, can actively prevent and correct the upper airway obstruction caused by tongue falling backward, and is flexible, comfortable and safe to adjust.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to a multifunctional face mask for non-invasive ventilation therapy. Background Technology

[0002] Non-invasive ventilation technology provides positive pressure ventilation support to patients through a face mask and is widely used in clinical scenarios such as painless diagnosis and treatment, intensive care, and sleep apnea syndrome. Its core advantage lies in eliminating the need for an invasive airway, reducing the risk of infection and patient trauma. However, existing non-invasive ventilation masks still have the following technical limitations in practical applications:

[0003] First, existing masks cannot actively maintain upper airway patency. Ordinary non-invasive ventilation masks only provide airway sealing and ventilation. When a patient experiences tongue retraction due to sedation, deep sleep, or neuromuscular dysfunction, the mask itself cannot relieve the resulting upper airway obstruction. Clinically, this usually requires medical staff to continuously manually lift the jaw or use oropharyngeal or nasopharyngeal airways, which is not only labor-intensive but also difficult to maintain stable and effective ventilation support during prolonged surgery or monitoring.

[0004] Secondly, manual mandibular slinging has significant operational limitations. On the one hand, prolonged manual slinging can easily lead to fatigue among medical staff, especially when monitoring multiple patients simultaneously or performing other procedures, making it unsustainable. On the other hand, it is difficult to precisely control and maintain the magnitude, angle, and position of the applied force manually, which may not only affect ventilation but also pose risks of temporomandibular joint discomfort, soft tissue injury, and even tooth damage. Furthermore, manual slinging occupies the medical staff's hands, limiting their flexibility during critical procedures.

[0005] Secondly, the integration of existing assistive devices with masks is poor. While independent mandibular supports or fixation devices exist on the market, they are mostly separate designs from non-invasive ventilation masks, lacking an integrated structure. This leads to easy displacement of the support device, poor fit with the mask, and even affects the mask's sealing performance, causing air leakage and reducing ventilation efficiency. Furthermore, existing support devices are not flexible or precise enough in adjusting height, angle, and lifting force, making it difficult to adapt to differences in mandibular anatomy among patients, such as mandibular length, short neck, and obesity, affecting individualized fit. In addition, rigid support structures can easily compress the soft tissues of the mandible during prolonged use, increasing the risk of skin pressure injuries and affecting patient comfort and compliance.

[0006] To address the aforementioned issues, the applicant proposes a multifunctional mask for non-invasive ventilation therapy. Summary of the Invention

[0007] The purpose of this invention is to provide a multifunctional mask for non-invasive ventilation therapy to solve the problems in the prior art.

[0008] To achieve the above objectives, the present invention provides the following technical solution: a multifunctional mask for non-invasive ventilation therapy, comprising:

[0009] The main body of the mask is used to cover the patient's mouth and nose area, with sealing pads at the edges and an air vent at the top.

[0010] A headband is used to secure the mask body to the patient's head;

[0011] The mandibular support module, connected to the mask body or headband, is used to lift the patient's mandible forward and upward.

[0012] The chin support module includes:

[0013] The support piece is shaped to fit the lower edge of the patient's mandible and chin, and has a cushioning pad on its inner surface;

[0014] An adjustable support arm, one end of which is connected to the mask body or headband, and the other end of which is connected to the support member, the support arm having at least one movable joint and / or length adjustment mechanism.

[0015] Optionally, the drive and locking mechanism is a manual precision adjustment mechanism, including a knob with scale markings, a gear and rack mechanism, a worm gear mechanism, or a universal joint mechanism with locking function.

[0016] Optionally, the support member has an arc-shaped or saddle-shaped structure, and the cushioning pad is made of medical-grade silicone or memory foam.

[0017] Optionally, the adjustable support arm includes multiple movable joints and multiple length adjustment mechanisms, enabling it to independently or in conjunction with other mechanisms to adjust its height, front-to-back distance, and angle in three-dimensional space.

[0018] Optionally, the chin support module can be integrated with the mask body or headband through a detachable or fixed connection.

[0019] Optionally, the mask body may also be provided with a forehead protector, which is fixedly connected to the mask body for assisting positioning and stable wearing.

[0020] Optionally, the chin support module is located on the lower outer side of the mask body, or is connected to the headband frame via a connector.

[0021] Optionally, the drive and locking mechanism is integrated inside the adjustable support arm or at the connection node.

[0022] Beneficial effects: 1. Actively maintains airway patency, reducing reliance on medical personnel.

[0023] This invention achieves mechanized upward and forward mandibular lifting by integrating an adjustable mandibular lifting module into the mask, actively preventing and correcting upper airway obstruction caused by tongue retraction, replacing the traditional manual lifting method, significantly reducing the operational burden on medical staff, and ensuring airway stability and ventilation continuity in long-term sedation or monitoring scenarios.

[0024] 2. Integrated design enhances ventilation safety and compatibility accuracy.

[0025] The chin support module is rigidly or adjustablely connected to the mask body or headband to form a stable whole, avoiding the displacement and sealing failure of independent support devices; the height, angle and front-to-back distance can be finely adjusted through multi-dimensional adjustable support arms to adapt to the differences in facial anatomy of different patients, realize individualized airway opening positioning, and improve ventilation efficiency and wearing stability.

[0026] 3. Combining comfort and safety, reducing the risk of complications.

[0027] The support piece features an arc-shaped structure that conforms to the shape of the mandible and is lined with a soft cushioning pad. Combined with optional pressure limiting or force feedback mechanisms, it effectively disperses pressure and avoids local pressure injury. While achieving stable support, it significantly improves patient comfort and reduces the risk of complications such as temporomandibular joint injury and skin pressure injury. Attached Figure Description

[0028] Figure 1 This is a side view structural diagram of an embodiment of the present invention;

[0029] Figure 2 This is a front view structural diagram of an embodiment of the present invention. Detailed Implementation

[0030] The preferred embodiments of the present invention are described below with reference to the accompanying drawings to make the technical content clearer and easier to understand. The present invention can be embodied in many different forms, and the scope of protection of the present invention is not limited to the embodiments mentioned herein.

[0031] This invention provides a multifunctional mask for non-invasive ventilation therapy, particularly suitable for patients at risk of tongue retraction, including but not limited to those undergoing anesthesia and sedation, ICU sedation, sleep apnea treatment, and neuromuscular diseases leading to muscle weakness. The core of this multifunctional mask lies in its integrated non-invasive ventilation function with a mandibular support function. Through mechanical means, it stably and adjustablely lifts the patient's mandible forward and upward, thereby actively preventing or correcting tongue retraction, maintaining upper airway patency, and ensuring both airtightness and patient comfort. The entire device mainly consists of three parts: the mask body, the headband, and the mandibular support module, with the mandibular support module being the key structure for achieving airway maintenance.

[0032] The mask body is the basic component used to cover the patient's mouth and nose area. Its overall contour is ergonomically designed to conform to the anatomical shape of the human face. The edges of the mask body are equipped with sealing gaskets, typically made of medical-grade silicone, thermoplastic elastomers, or flexible foam materials. These gaskets offer good elasticity and biocompatibility, forming an airtight seal upon contact with facial skin to prevent gas leakage during positive pressure ventilation. The shape of the sealing gaskets can be triangular, circular, or oval, depending on the mask type, with thickened or reinforced sealing structures in the bridge of the nose, cheek, and jaw areas to accommodate different facial curvatures. The upper part of the mask body features a ventilation port for connecting the breathing tubing, enabling communication with a ventilator or positive pressure ventilation device. The ventilation port typically uses a standard-sized conical or snap-on structure for quick connection and disconnection with breathing tubing from different brands. The mask body itself can be injection molded from polycarbonate, polypropylene, or other medical-grade transparent plastic materials. The transparency allows healthcare personnel to observe the skin condition and secretions in the patient's mouth and nose area, enabling timely detection of potential problems. In some preferred embodiments, a forehead protector is also provided on the main body of the mask. This forehead protector is fixedly connected to the main body of the mask, typically through a one-piece molding or a detachable snap-fit ​​method. The forehead protector serves to assist in positioning and increase wearing stability. When the patient wears the mask, the forehead protector contacts the patient's forehead, forming a third support point. Together with the nose area and chin support module of the main body of the mask, this constitutes a three-point support system, effectively dispersing the pressure of the mask on the face, preventing local pressure sores, and improving the mask's resistance to displacement under headband fixation. A soft cushioning pad can also be provided on the inner side of the forehead protector to enhance comfort.

[0033] A headband is an auxiliary fixation device used to secure the mask body to the patient's head. It is typically composed of elastic webbing, silicone straps, or adjustable straps with Velcro. The headband is designed with a multi-point fixation method, commonly a four-point or six-point design, extending from both sides of the patient's forehead and cheeks back to the occiput or top of the head. It is tightened and secured using adjustable buckles or Velcro. The tension of the headband needs to be moderate, ensuring a tight seal between the mask's sealing pad and the facial skin to prevent air leakage, while avoiding excessive pressure that could cause pressure sores on the facial soft tissues. In a preferred embodiment, the connection point between the headband and the mask body is equipped with a quick-release buckle for easy removal of the mask in an emergency. The headband is preferably made of a breathable, soft, and elastic fabric, with an inner lining that can absorb moisture and wick away sweat to reduce discomfort and skin irritation during prolonged wear.

[0034] The chin support module is the core innovation of this invention. This module connects to the mask body or headband and is used to lift the patient's mandible forward and upward, thereby moving the tongue base forward, opening the pharynx, and relieving upper airway obstruction. The chin support module mainly consists of three parts: a support component, an adjustable support arm, and a drive and locking mechanism. The support component is the part that directly contacts the lower edge of the patient's mandible and chin. Its shape is designed as an arc or saddle shape to conform to the anatomical curve of the mandible to the greatest extent. The inner surface of the support component, the side that contacts the skin, is lined with a soft, breathable cushioning pad. This cushioning pad is preferably made of medical-grade silicone, memory foam, or polyurethane foam, which has good elasticity and pressure dispersion properties. The surface of the cushioning pad can be designed with micro-protrusions or a textured structure to increase friction and prevent the support component from sliding or shifting during use. These micro-protrusions also massage the local skin, promote blood circulation, and reduce the risk of pressure sores. The overall contour of the support piece has been ergonomically optimized to accommodate the different jaw anatomy differences of patients, from children to adults, and from those with long, thin faces to those with short necks and obese faces. This ensures that the pressure is evenly distributed during the support process and avoids localized stress concentration that could cause damage to the temporomandibular joint or mandible.

[0035] The adjustable support arm is a key structure connecting the support member to the mask body or headband. This support arm has at least one movable joint and / or a length adjustment mechanism, allowing it to adjust its position and angle in three-dimensional space, thereby achieving precise positioning of the support member relative to the patient's mandible. In a preferred embodiment, the adjustable support arm includes a first arm segment and a second arm segment. One end of the first arm segment is connected to the mask body or headband via a first joint, and the other end of the first arm segment is connected to one end of the second arm segment via a second joint. The other end of the second arm segment is connected to the support member via a third joint. The first, second, and third joints are all ball joints, universal joints, or pivot joints, enabling multi-degree-of-freedom rotation and oscillation. The first and second arm segments themselves can be designed as telescopic sleeve structures, i.e., the inner and outer sleeves achieve stepless or stepped length adjustment through threads, snaps, or friction fits. Through this multi-joint, multi-degree-of-freedom design, the adjustable support arm can achieve independent or coordinated adjustment in height, forward / backward, left / right directions, as well as pitch, yaw, and rotation angles, thereby precisely positioning the support component at the optimal support position for the patient's mandible. In another preferred embodiment, the adjustable support arm is made of flexible, bendable tubing, such as a shaped metal hose or a malleable plastic tube. This type of tubing can be bent into any shape when external force is applied and retains that shape after the external force is removed, thus enabling quick and intuitive adjustment of the support position. This design simplifies the complexity of the adjustment mechanism, reduces manufacturing costs, and still meets the needs of individualized adaptation.

[0036] The drive and locking mechanism is integrated inside or at the connection point of the adjustable support arm to achieve adjustment and locking of the lifting position. Depending on the application scenario and cost considerations, the drive and locking mechanism can be designed in two main types: a manual precision adjustment type or a micro-electric drive type. The manual precision adjustment drive and locking mechanism is the basic embodiment of this invention, which includes a knob with scale markings, a gear and rack mechanism, a worm gear mechanism, or a universal joint mechanism with locking function. Taking the gear and rack mechanism as an example, when the medical staff rotates the adjustment knob, the knob drives the pinion to rotate, and the pinion meshes with the rack set on the arm segment, thereby driving the arm segment to extend and retract in a straight line, achieving precise adjustment of the lifting height. The scale markings can be set around the knob or on the surface of the arm segment to indicate the current adjustment position, facilitating the recording and reproduction of personalized settings for different patients. The worm gear mechanism has a self-locking characteristic, meaning that once adjusted to the correct position, it can maintain a stable position without additional locking devices, preventing changes in the lifting position due to vibration or slight patient movement during ventilation. The universal joint mechanism with locking function allows medical staff to freely adjust the lifting direction at any angle. After adjustment, the universal joint can be locked by locking the nut or lever to achieve rigid fixation of the position. The advantages of the manual precision adjustment mechanism are its simple structure, low cost, high reliability, no power supply required, and suitability for various medical environments. It can quickly complete the adaptation setting, especially in scenarios such as emergency and anesthesia induction where ventilation support needs to be established rapidly.

[0037] A preferred embodiment of the invention is a miniature electric drive and locking mechanism, comprising a miniature motor, a transmission mechanism, and a controller. It can be electrically adjusted via manual buttons or a simple control panel and can memorize or set positions. The miniature motor is typically a miniature DC geared motor or a stepper motor, characterized by its small size, high torque, and high control precision. The transmission mechanism can employ a screw-nut mechanism, a rack and pinion mechanism, or a worm gear mechanism to convert the motor's rotational motion into linear or rotational motion, thereby driving the extension, retraction, or swing of the adjustable support arm. The controller can be integrated into the outer shell of the mask body, equipped with several adjustment buttons, including an up button, a down button, a forward button, a backward button, and an angle adjustment button. Medical personnel can achieve stepless adjustment of the lifting position by pressing these buttons. In a more advanced embodiment, the controller also has a memory function, capable of storing personalized lifting parameters for multiple patients. When the same patient needs to use the device again, a single button press automatically restores the previously set optimal position, greatly simplifying the operation. The miniature electric drive mechanism also allows data communication with hospital monitoring systems or ventilators, enabling remote adjustment or automatic feedback control. For example, when the ventilator detects an airway obstruction waveform in a patient, it can automatically send a command to the controller to drive the lift module to increase the lift force or change the lift angle until the airway is clear. This closed-loop control method further improves the automation level and safety of ventilation.

[0038] To prevent damage to the patient's mandibular soft tissue or temporomandibular joint due to excessive force during the lifting process, the mandibular lifting module of this invention can preferably integrate a force feedback or limiting mechanism. The force feedback or limiting mechanism can be at least one of a spring buffer device, a pressure sensor, or a mechanical limiting structure. The spring buffer device is located at the connection between the adjustable support arm and the lifting component. Its core component is a compression spring or spring sheet. When the lifting force exceeds a preset threshold, the spring compresses and deforms, absorbing excess energy, thereby limiting the maximum pressure acting on the patient's mandible within a safe range. The spring buffer device can also provide a certain amount of elastic floating, allowing the lifting component to adaptively adjust to the slight movements of the patient's mandible, further improving comfort. The pressure sensor can monitor the contact pressure between the lifting component and the mandibular skin in real time and transmit the pressure signal to the controller or an external monitor. When the pressure exceeds the safe threshold, the controller can issue an audible and visual alarm to alert medical staff, or automatically drive the micro motor to rotate in the opposite direction, reducing the lifting force until the pressure returns to the normal range. The pressure sensor allows for more precise and quantifiable control of the lifting force, avoiding errors that might arise from relying solely on the experience of medical staff. The mechanical limiting structure restricts the adjustment range of the adjustable support arm through physical barriers. For example, limiting bosses or grooves are installed on the arm segment. When adjusted to the limit position, the boss contacts the groove wall, preventing further adjustment and thus preventing structural damage or patient injury due to over-adjustment.

[0039] In specific clinical applications, the usage procedure of the multifunctional face mask of this invention is as follows: First, select a face mask body of appropriate size according to the patient's facial size and shape, and initially fix the face mask body to the patient's face using the headband. Adjust the headband tension to ensure good contact between the sealing pad and the facial skin, ensuring airtightness. Then, medical staff manually or electrically adjust the adjustable support arm so that the lifting component contacts the lower edge of the patient's mandible and chin. During adjustment, medical staff can support the patient's mandible with one hand to position it in a forward and upward position to simulate an open airway, while adjusting the joints and length of the support arm with the other hand to maintain this position. After adjustment, lock the movable parts of the support arm using the locking mechanism to prevent displacement during use. For embodiments with force feedback or limiting mechanisms, medical staff can observe the pressure sensor readings or judge whether the lifting force is appropriate by observing the compression degree of the spring buffer device, ensuring effective airway opening without causing tissue damage. After completing the adjustment of the lifting module, connect the ventilation interface to the breathing tubing and start the ventilator for non-invasive ventilation. Throughout the treatment, the chin lift module continuously and stably provides forward and upward lifting force, keeping the tongue base forward and the pharynx open. This ensures that the positive pressure airflow from the ventilator can smoothly enter the airway, avoiding ineffective ventilation or hypoxemia caused by tongue retraction. After treatment, the locking mechanism is first released, the adjustable support arm is reset, and then the mask body is removed. The entire process is safe and efficient.

[0040] For patients requiring prolonged sedation or monitoring, such as ICU patients or those undergoing painless gastroscopy or colonoscopy, the advantages of this multifunctional mask are particularly evident. During prolonged sedation, patients' muscle strength further declines, and the risk of tongue retraction persists. Traditional manual support methods are difficult to maintain for hours or even tens of hours, while the mechanical support module of this invention can work continuously and stably, without time constraints, greatly reducing the workload of medical staff and allowing them to focus on other important tasks such as patient monitoring and medication. Simultaneously, due to the precise controllability of the support force and the limiting protection mechanism, even under prolonged support, it will not cause compressive damage to the patient's jaw, reducing the risk of iatrogenic complications. For patients with special anatomical structures such as obesity or short necks, conventional masks often fail to achieve a good seal, and jaw support is difficult. However, the multidimensional adjustable support arm of this invention can flexibly adjust the support angle and position to find the optimal airway opening path. Combined with the adaptive deformation capability of the sealing pad on the mask body, it achieves a good fit to complex facial structures, significantly improving the success rate and safety of non-invasive ventilation for these patients with difficult airways.

[0041] Regarding material selection, all components of this invention preferably utilize biocompatible materials that meet medical device standards. The main body of the mask is made of transparent polycarbonate or polysulfone, which possesses excellent transparency, mechanical strength, and chemical resistance, facilitating observation and easy cleaning and disinfection. The sealing gasket and cushioning pad are made of medical-grade liquid silicone rubber or thermoplastic elastomers; these materials are soft, non-toxic, odorless, and non-allergenic, ensuring safe and reliable long-term skin contact. The structural components of the adjustable support arm are made of high-strength engineering plastics such as polyetheretherketone (PEEK) or polyoxymethylene (POM), or lightweight metals such as aluminum alloys or titanium alloys, to balance strength and lightweight requirements. The headband is made of breathable elastic fabric, and silicone pads can be added to the skin-contacting parts to reduce friction. All components in contact with the patient should be designed for easy disassembly and cleaning, facilitating disinfection after use and preventing cross-infection.

[0042] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. It will be apparent to those skilled in the art that the invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered illustrative and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the scope of the invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

[0043] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A multifunctional face mask for non-invasive ventilation therapy, characterized in that, include: The main body of the mask is used to cover the patient's mouth and nose area, with sealing pads at the edges and an air vent at the top. A headband is used to secure the mask body to the patient's head; The mandibular support module, connected to the mask body or headband, is used to lift the patient's mandible forward and upward. The chin support module includes: The support piece is shaped to fit the lower edge of the patient's mandible and chin, and has a cushioning pad on its inner surface; An adjustable support arm, one end of which is connected to the mask body or headband, and the other end of which is connected to the support member, the support arm having at least one movable joint and / or length adjustment mechanism.

2. The multifunctional face mask according to claim 1, characterized in that, The drive and locking mechanism is a manual precision adjustment mechanism, including a knob with scale markings, a gear and rack mechanism, a worm gear mechanism, or a universal joint mechanism with locking function.

3. The multifunctional face mask according to claim 1, characterized in that, The support component has an arc-shaped or saddle-shaped structure, and the cushioning pad is made of medical-grade silicone or memory foam.

4. The multifunctional face mask according to claim 1, characterized in that, The adjustable support arm includes multiple movable joints and multiple length adjustment mechanisms, enabling it to independently or in conjunction with other mechanisms to adjust its height, front-to-back distance, and angle in three-dimensional space.

5. The multifunctional face mask according to claim 1, characterized in that, The chin support module is integrated with the mask body or headband through a detachable or fixed connection.

6. The multifunctional face mask according to claim 1, characterized in that, The main body of the mask is also equipped with a forehead protector, which is fixedly connected to the main body of the mask to assist in positioning and stable wearing.

7. The multifunctional face mask according to claim 1, characterized in that, The chin support module is located on the lower outer side of the mask body, or is connected to the headband frame via a connector.

8. The multifunctional face mask according to claim 1, characterized in that, The drive and locking mechanism is integrated inside the adjustable support arm or at the connection node.

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