Breathing machine frame assembly for conveying gas
By designing a frame assembly with a symmetric hollow pipe and an automatic adjustment mechanism, the problems of easy falling off and excessive facial pressure in the prior art are solved, and a more stable, comfortable and smooth sleep breathing disorder treatment effect is achieved.
Patent Information
- Application Number
- CN202311720909.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-12-14
- Publication Date
- 2025-06-17
AI Technical Summary
The frame components of existing sleep breathing disorder treatment equipment are prone to fall off due to gravity and the tension of the gas delivery device during use, resulting in the displacement of the patient's interface pad and affecting the treatment effect. In addition, traditional frames tend to squeeze the pipes when lying on the side, affecting the smooth airflow, and excessive facial pressure may lead to red marks and pressure ulcers.
A frame assembly with a symmetrical hollow duct was designed with an air inlet disposed on the patient's forehead, which extends from the nose to the temporal and forehead, forming a contour surrounding the eyes and nose. The frame assembly has at least 3 headband connection points, providing more stable fixation, and is provided with an automatic adjustment mechanism to accommodate different facial contours.
The frame assembly is more stable, reducing the risk of shedding and displacement, ensuring smooth airflow, and reducing the occurrence of red marks and pressure ulcers by sharing facial pressure. At the same time, the automatic adjustment mechanism and multiple headband connection points improve the stability and comfort of wearing.
Smart Images

Figure CN120154783A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a device for delivering a therapeutic gas flow to a patient's airway, and more particularly, to a frame assembly with a hollow conduit for connecting a patient interface pad for delivering gas. Background Art
[0002] Sleep is an important part of daily life. People spend about one-third of their time sleeping, and sleep is important for many brain functions, helping to restore the immune, nervous, skeletal, and muscular systems. However, some groups suffer from sleep disorders such as insomnia, sleep apnea, narcolepsy, etc., resulting in poor sleep quality or chronic sleep deprivation, leading to problems such as inattention, slowed reaction, and a weakened immune system, and also increasing the risk of diseases such as cardiovascular disease, hypertension, and diabetes. In order to ensure good sleep, patients need lifelong care or treatment. Among them, the commonly used treatment method for sleep apnea patients is positive airway pressure ventilation (PAP), and continuous positive airway pressure ventilation (CPAP) is commonly used. Specifically, positive pressure pressurized breathing gas provided by a flow generator is delivered to the patient's airway to treat sleep breathing disorders. CPAP treatment devices generally include an air flow generator, a gas delivery device, and a mask system; the mask system can be roughly divided into three parts: a frame assembly, a headband, and a patient interface pad. The patient interface pad is used to seal the patient's airway, and the frame assembly and the headband cooperate to fix the patient interface pad on the patient's head to ensure that the pressurized air flow is correctly transported to the patient's airway.
[0003] Except for the patient interface pad, the frame assembly has the largest contact area with the face. Therefore, the wearing comfort of the frame assembly is extremely important, and it is necessary to consider whether the shape design of the frame will affect the patient's daily life. While ensuring comfort and aesthetics, additional functions can also be added to the frame assembly. Currently, there are several common types of frames on the market. For example, a frame with a forehead support has better stability and can disperse the pressure of the mask system on the bridge of the nose. However, the upper part of this type of frame is usually designed larger and heavier, which is not friendly to patients who need to wear glasses; a frame with left and right connectors can avoid the upper part of the patient's face, ensuring a wider field of vision for the patient and allowing them to wear glasses. However, in order to ensure the stability of the connectors, the connectors of this type of frame are made of rigid or semi-rigid materials, which will cause the connectors to press on the face when the patient is lying on their side, resulting in pressure sores and red marks. To make the frame more comfortable, manufacturers have made various improvements, such as making the frame of gel material or adding fabric to the frame, but there will still be cases of pressing on the face. At the same time, the gas interface of traditional frames is usually set in the center. After connecting the gas delivery device, the breathing tube extends from the patient's nose to the neck. When the patient turns over or moves their head during sleep, the breathing tube is likely to become entangled and knotted.
[0004] Recently, a new type of frame has emerged on the market. It is made of an elastomer and has a hollow gas delivery tube that extends from the patient's nasal side to the top of the head. This frame can reduce the pressure on the face. However, the frame sets the gas interface on the top of the head and only uses two headband connection points above the ears to fix the frame. There is no other external force around the patient interface pad except its own gravity and the tensile force from the connection points on the frame. Such a state is relatively balanced when the patient's head is upright. However, when the patient is in a sleeping state, due to the connection of the gas delivery device at the top of the head of the frame plus its own gravity, it is very likely to slip from the top of the patient's head. And the sliding of the frame will surely affect the position of the patient interface pad, further affecting the treatment effect. Summary of the Invention
[0005] Based on this, it is necessary to provide a frame component that is more comfortable than traditional frame components and more stable than the new type of frame in the prior art to address the above deficiencies.
[0006] A ventilator frame component for delivering gas, which is used to deliver positive pressure pressurized breathing gas from a flow generator to a patient's airway to treat sleep apnea, includes:
[0007] A frame having a first interface disposed on the patient's forehead to receive positive pressure pressurized breathing gas and a second interface adjacent to the patient's nasal side;
[0008] The frame further includes two symmetrical hollow pipes connecting the first interface disposed at the center of the frame and the two second interfaces respectively disposed on the patient's nasal side, for delivering positive pressure pressurized breathing gas from the first interface to the second interface. The hollow pipe has a front wall, a rear wall, and an inner edge and an outer edge formed at the junction of the front wall and the rear wall;
[0009] Fins for connecting a headband to fix the frame on the patient's face, including a first fin disposed on the outer edge of the hollow pipe adjacent to the first interface and a second fin disposed on the outer edge of the hollow pipe adjacent to the second interface;
[0010] Wherein, the hollow pipe extends upward from the first nasal side of the patient to the first temporal region, then upward to the forehead, and then extends to the second temporal region to the second nasal side, forming a contour that at least partially surrounds the patient's eyes and nose.
[0011] In one embodiment, the fin is integrally formed with the frame and is made of silicone with a Shore hardness of 30A - 70A.
[0012] In one embodiment, the first fin has at least one opening for connecting a headband, and the second fin has at least one opening for connecting a quick release member.
[0013] In one embodiment, the frame assembly further includes an automatic adjustment mechanism disposed on the hollow pipe adjacent to the first interface for automatically adjusting the length or width of the hollow pipe to adapt to the facial contours of different patients.
[0014] The present invention also discloses a ventilator frame assembly for delivering gas, which is used to deliver positive pressure pressurized breathing gas from a flow generator to a patient's airway to treat sleep apnea, and includes:
[0015] A frame having a first interface disposed on the patient's forehead to receive positive pressure pressurized breathing gas and a second interface adjacent to the patient's nasal side;
[0016] The frame further includes two symmetric hollow pipes connecting the first interface disposed at the center of the frame and the two second interfaces respectively disposed on the patient's nasal side for delivering positive pressure pressurized breathing gas from the first interface to the second interface. The hollow pipe has a front wall, a rear wall, and inner and outer edges formed at the junction of the front wall and the rear wall;
[0017] Flaps for connecting a headband to fix the frame on the patient's face, including a first flap disposed on the outer edge of the hollow pipe adjacent to the first interface and a second flap disposed on the outer edge of the hollow pipe adjacent to the second interface;
[0018] A rigid interface for forming a detachable connection with a patient interface pad, disposed at the second interface end of the frame and forming a non-detachable connection with the second interface.
[0019] In one embodiment, the frame assembly further includes a quick release member for connecting the headband and the second flap, disposed at one end of the second flap away from the hollow pipe and forming a detachable connection with the second flap.
[0020] In one embodiment, the connection mode between the rigid interface and the second interface is one of co-molding and welding.
[0021] In one embodiment, the rigid interface has at least one protrusion for connecting with a patient interface pad.
[0022] The present invention also discloses a ventilator frame assembly for delivering gas, which is used to deliver positive pressure pressurized breathing gas from a flow generator to a patient's airway to treat sleep apnea, and includes:
[0023] A frame made of a continuous hollow elastomer, having a first interface for receiving positive pressure pressurized breathing gas, a second interface adjacent to the patient's nasal side, and a hollow pipe extending between the patient's eyes and ears to connect the first interface and the second interface;
[0024] The fins, which are used to connect the headband to fix the frame on the patient's face, include a first fin provided on the hollow pipe adjacent to the first interface and a second fin provided on the hollow pipe adjacent to the second interface;
[0025] Wherein the first fin has at least one, extending upward from the hollow pipe above the ear, and having at least one hole for connecting the headband so as to give the frame a pulling force toward the back of the head when worn;
[0026] Wherein the second fin has at least two, extending downward from the hollow pipe below the ear, for connecting the headband so as to give the frame a pulling force toward the back of the head when worn to pull the patient interface pad closer to the patient's airway;
[0027] Wherein a support portion is provided on the inner wall of the hollow pipe corresponding to the first interface, for preventing the gas delivery device from touching the bottom and closing the pressurized air flow when the first interface is connected to the gas delivery device.
[0028] In one embodiment, the first interface has an annular wall extending into the inner cavity of the hollow pipe, for enhancing the connection and sealing with the gas delivery device.
[0029] In one embodiment, the hollow pipe has a front wall away from the patient's face and a rear wall close to the patient's face, wherein the first interface penetrates the front wall of the hollow pipe.
[0030] In one embodiment, the hollow pipe extends upward from the first nasal side of the patient to the first temporal part and then extends to the second temporal part and then to the second nasal side, forming a contour that at least partially surrounds the patient's eyes and nose.
[0031] In one embodiment, the support portion is a strip-shaped protrusion formed from the inner wall of the hollow pipe, and the length of the support portion should be greater than the distance from the intersection point of the first interface and the straight line extending in the length direction of the support portion.
[0032] The present invention further discloses a ventilator frame assembly for delivering gas, which is used to deliver positive pressure pressurized breathing gas from a flow generator to a patient's airway to treat sleep apnea, including:
[0033] A frame, having a first interface for receiving positive pressure pressurized breathing gas and a second interface adjacent to the patient's nasal side;
[0034] The frame further includes two symmetric hollow ducts connecting the first interface disposed at the center of the frame and the two second interfaces respectively disposed on the nasal sides of the patient, for delivering positive pressure pressurized breathing gas from the first interface to the second interface. The hollow duct has a front wall, a rear wall, and inner and outer edges formed at the junction of the front wall and the rear wall;
[0035] An automatic adjustment mechanism is disposed on the hollow duct adjacent to the first interface and not exceeding the zygomatic bone of the patient, for automatically adjusting the length or width of the hollow duct to adapt to the facial contours of different patients;
[0036] Flaps for connecting a headband to fix the frame on the patient's face, including a first flap extending upward toward the ear from the outer edge of the hollow duct adjacent to the first interface, and a second flap extending downward toward the ear from the outer edge of the hollow duct adjacent to the second interface, wherein the second flap has at least one opening for connecting a quick-release member or a headband;
[0037] Wherein, the hollow duct extends upward from the first nasal side of the patient to the first temporal region and then extends to the second temporal region and then to the second nasal side, forming a contour at least partially surrounding the patient's eyes and nose.
[0038] In one embodiment, the automatic adjustment mechanism is composed of a plurality of folded walls made of an elastomer, having a plurality of recesses and protrusions.
[0039] In one embodiment, the front wall of the hollow duct is arc-shaped and the rear wall is flat.
[0040] In one embodiment, the quick-release member is in the form of a magnetic buckle or a clip.
[0041] In one embodiment, one end of the hollow duct adjacent to the first interface is larger than one end adjacent to the second interface.
[0042] The present invention discloses a ventilator frame assembly for delivering gas, for delivering positive pressure pressurized breathing gas from a flow generator to a patient airway to treat sleep apnea, including:
[0043] A frame made of a continuous hollow elastomer, having a first interface disposed on the patient's forehead to receive positive pressure pressurized breathing gas, a second interface adjacent to the patient's nasal side, and a hollow duct extending between the patient's eyes and ears to connect the first interface and the second interface;
[0044] An automatic adjustment mechanism is disposed on the hollow duct adjacent to the first interface, for automatically adjusting the length or width of the hollow duct to adapt to the facial contours of different patients;
[0045] A rigid interface, made of a material more rigid than the frame, is provided at the second interface end of the frame and forms a non-detachable connection with the second interface;
[0046] Flaps for connecting the headband to fix the frame on the patient's face, including a first flap provided at the outer edge of the hollow pipe adjacent to the first interface and a second flap provided at the outer edge of the hollow pipe adjacent to the second interface;
[0047] Wherein, the hollow pipe extends upward from the first nasal side of the patient to the first temporal part, then upward to the forehead and then extends to the second temporal part to the second nasal side, forming a contour that at least partially surrounds the patient's eyes and nose.
[0048] In one embodiment, the automatic adjustment mechanism is integrally formed with the hollow pipe and is composed of silicone rubber with a Shore hardness of 30A - 70A.
[0049] In one embodiment, the frame assembly further includes a connecting member having a first end connecting the rigid interface and a second end connecting the patient interface pad, forming a detachable connection with the rigid interface and the patient interface pad.
[0050] In one embodiment, the shape and size of the first end of the connecting member correspond to those of the rigid interface, and the shape and size of the second end correspond to those of the patient interface pad.
[0051] Implementing the ventilator frame assembly for delivering gas of the present invention has at least the following beneficial effects:
[0052] 1. The frame assembly of the present invention is more stable compared with the existing same-type frames with pipes but with the air inlet provided on the patient's head. For the pipe frames of the prior art, when the patient lies supine, it is easy to fall off under its own gravity and the pulling force of the gas delivery device, thus prying the patient interface pad and causing air leakage and other situations; while the frame of the present invention covers the patient's face, and the central air inlet of the frame is provided on the patient's forehead. In the supine state, the patient's forehead has an upward supporting force on the frame, making it not easy for the center of the frame to slide off under the action of gravity, resulting in displacement of the patient interface pad and causing air leakage. And the gas interface of the frame is provided on the patient's face, and the patient can judge the position of the gas interface through a mirror, which is easier to install gas delivery devices such as elbows than the prior art with the interface provided on the headband. At the same time, the frame is provided with an automatic adjustment mechanism, which can automatically adjust according to the patient's face shape under the dual action of gravity and pulling force when the patient wears it, and better fits the patient's facial contour.
[0053] 2. The frame component of the present invention has at least three headband connection points, which is less likely to leak air compared to the existing pipe frame with connection points. For the pipe frame of the prior art, there are only two pulling forces towards the back of the head on the frame above the ears, which cannot ensure that the frame will not slide down; and when the patient is in the supine position, the pulling force of the headband on the frame towards the back is more likely to pull the frame off the top of the head; at the same time, there is no additional pulling force around the patient interface pad. If the patient lies on their side, the patient interface pad is very likely to deviate from the predetermined position and deviate from the patient's airway. However, the frame of the present invention has at least three points of pulling force. One is to apply a force upwards and backwards towards the head above the frame to ensure that the frame will not slide down under the action of gravity, and the upper part of the frame can fit the patient's face; the other two are pulling forces towards the back of the head near the nasal side of the frame, making the frame fit the face more closely and indirectly applying a force close to the nose to the patient interface pad. At the same time, at least three headband connection points can wrap the head in all directions, making it more stable and ensuring that the frame component and the patient interface pad are minimally affected by the turning over of the user during sleep at night and the changes in facial muscles. And the headband is provided with an elastic fixing device, which can fix the breathing tube on the patient's head, further enhancing the stability and reliability of the treatment component. At the same time, placing the gas delivery device on the head and fixing it with a headband can effectively avoid the breathing tube falling off or winding around the patient. For the convenience of disassembly, the frame component is also provided with a quick release member, allowing the patient to quickly separate the frame and the headband through the quick release member, making it more convenient to wear without repeatedly adjusting the length of the headband.
[0054] 3. The air flow of the frame component of the present invention is smoother. Compared with the design of the existing type of pipe frame extending from the patient's nasal side to the top of the head, although the pipe frame of the prior art avoids the vertex of the cheekbone, it still passes through the bones on the side of the patient's head. When the patient lies on their side, it is very easy to squeeze one side of the pipe, affecting the air flow into the patient's airway and also affecting the sleep comfort. However, the frame of the present invention is mainly placed in the front position of the patient's face, avoiding the protruding bones, such as the cheekbone and the frontal bone. In this way, when the patient lies on their side, it will be the relatively soft position of the face - the cheek touches the frame, which is not easy to squeeze the pipe and can ensure the smoothness of the air flow during the treatment process to the greatest extent.
[0055] 4. The frame component of the present invention also comes with a connecting member. By replacing the connecting member, the same frame can be connected to patient interface pads of different interface types, allowing patients to choose a suitable patient interface pad. For example, a patient interface pad with a male head can be paired with a connecting member with a female head, and conversely, a patient interface pad with a female head can be paired with a connecting member with a male head. In this way, without changing the frame and the patient interface pad, the two can be made to fit by simply replacing a small part, achieving a modular effect. This is a better choice for both producers and patients; producers are not limited to designing patient interface pads that match the frame interface and have more room for pioneering designs; patients can also choose to use patient interface pads of different types, structures, and functions. At the same time, the adaptation of multiple frames to multiple patient interface pads is also beneficial to the environment. Designing and replacing the connecting member separately means less consumption of raw materials, effectively protecting existing resources and promoting sustainable use of energy, less production waste, and reduced carbon emissions and climate change.
[0056] 5. Compared with the prior art non-pipeline type frames that seal around the patient's airway, the frame component of the present invention has a larger contact area with the face and is made of an elastomer, which can effectively distribute the pressure brought by the headband, exerting less pressure on the face and not squeezing the patient. At the same time, compared with the prior art, the gas interface of the frame component of the present invention is placed at a position farther away from the patient's face, which can avoid the exhaust flow from affecting the patient's sleep and reduce the patient's perception of noise. BRIEF DESCRIPTION OF THE DRAWINGS
[0057] Figure 1 A perspective schematic view of the frame component in an embodiment of the present invention;
[0058] Figure 2 A front view of the frame component in an embodiment of the present invention;
[0059] Figure 3 A schematic diagram of the division of the skeletal regions of the human head;
[0060] Figure 4 A front view of the frame component in a worn state in an embodiment of the present invention;
[0061] Figure 5 A supine schematic view of the frame component in a worn state in an embodiment of the present invention;
[0062] Figure 6 A left view of the frame component in a worn state in an embodiment of the present invention;
[0063] Figure 7 A side-lying schematic view of the frame component in a worn state in an embodiment of the present invention;
[0064] Figure 8 Schematic diagram of the connection of the frame component, headband, and patient interface pad in an embodiment of the present invention;
[0065] Figure 9 Exploded schematic diagram of the frame component and the quick release member in an embodiment of the present invention;
[0066] Figure 10 Schematic diagram of the usage state of the frame component in an embodiment of the present invention;
[0067] Figure 11 Schematic diagram of the connection of the frame component and the headband in multiple embodiments of the present invention;
[0068] Figure 12 Schematic diagram of the first interface and the support part in multiple embodiments of the present invention;
[0069] Figure 13 Schematic diagram of the cross-section of the hollow pipe in multiple embodiments of the present invention;
[0070] Figure 14 Partially enlarged schematic diagram of the automatic adjustment mechanism in multiple embodiments of the present invention;
[0071] Figure 15 Schematic diagram of the position of the automatic adjustment mechanism of the frame component in the second embodiment of the present invention;
[0072] Figure 16 Left view of the wearing state of the frame component in the third embodiment of the present invention;
[0073] Figure 17 Exploded schematic diagram of the frame component and the connection mechanism in the fourth embodiment of the present invention;
[0074] Figure 18 Schematic diagram of the second interface of the frame component in the fifth embodiment of the present invention;
[0075] Figure 19 Schematic diagram of the frame component with a comfort layer in the sixth embodiment of the present invention;
[0076] Figure 20 Schematic diagram of the frame component connected to a patient interface pad of the oronasal mask type in the first embodiment of the present invention;
[0077] Figure 21 Schematic diagram of the frame component connected to a patient interface pad of the full-face mask type in the first embodiment of the present invention. Detailed implementation manners
[0078] To make the above objects, features, and advantages of the present invention more apparent and understandable, the following provides a detailed description of the specific embodiments of the present invention with reference to the accompanying drawings. Many specific details are set forth in the following description to facilitate a thorough understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the spirit of the present invention. Therefore, the present invention is not limited by the specific embodiments disclosed below.
[0079] In view of the existing pipeline-type frame air inlet being placed on the top of the head with only two headband connection points, which causes the frame to be prone to displacement and detachment during sleep, affecting the sealing of the patient interface pad, and when lying on the side, it is easy to squeeze one side of the pipeline, resulting in blockage and affecting the air flow; and the traditional frame exerts too much pressure on the face, easily causing facial red marks and pressure sores, the present invention provides a frame with symmetrical hollow pipelines, and the air inlet is arranged on the patient's forehead, extending and surrounding from the front side of the patient's head, avoiding the problem that the skull is prone to squeeze the frame when lying on the side, and at least 3 headband connection points are provided to make the fixation of the headband on the frame assembly stronger and the patient's wearing more stable.
[0080] Specifically, please refer to Figures 1 to 9 , the frame assembly of the present invention includes a frame 1, fins, an automatic adjustment mechanism 14, and a rigid interface 2. The frame 1 is made of a continuous hollow elastomer, having a certain elasticity and deformation ability, and the material is one or more of silicone, rubber, latex, and TPE, with a hardness range of Shore 30A - 70A, preferably a hardness of Shore 40A - 60A, and more preferably made of silicone with a hardness of Shore 30A - 70A. The frame 1 has a first interface 111 for receiving positive pressure pressurized breathing gas and a second interface 112 adjacent to the patient's nasal side. The first interface 111 is usually circular. To ensure sufficient gas enters the frame 1 to guarantee the treatment effect, the diameter of the first interface 111 needs to be greater than 15 mm; the first interface 111 is arranged at the center of the frame 1. To ensure that the frame 1 will not be too large, causing problems such as excessive weight, blocking the line of sight, and unstable connection with the gas delivery device 8, the diameter of the first interface 111 is not greater than 35 mm. In some forms, the first interface 111 can also be other shapes, such as square, oval, triangle, etc. The first interface 111 is used to connect with the gas delivery device 8 and has an annular wall 1110 extending into the inner cavity of the hollow pipeline 12 for enhancing the connection and sealing with the gas delivery device 8. The second interface 112 is closer to the nose. Compared with the large area of the forehead, the facial lines here are more undulating and the space is smaller, so the circumference of the second interface 112 is smaller than that of the first interface 111.
[0081] The frame 1 further includes two symmetrical hollow pipes 12 connecting the first interface 111 disposed at the center of the frame 1 and the two second interfaces 112 respectively disposed on the nasal sides of the patient. The hollow pipes 12 are used to convey positive-pressure pressurized breathing gas from the first interface 111 to the second interface 112, extending from the first nasal side (left side) of the patient upward to the first temporal region (left side) and then extending to the second temporal region (right side) to the second nasal side (right side), forming a contour that at least partially surrounds the patient's eyes and nose, having a front wall 121 (away from the patient's face), a rear wall 122 (close to the patient's face), and an inner edge 124 (the edge close to the patient's eyes when in use) and an outer edge 125 formed at the junction of the front wall 121 and the rear wall 122. Among them, the first interface 111 penetrates the front wall 121 of the hollow pipe 12 for connecting the gas delivery device 8, and the second interface 112 is connected to the patient interface pad 7 to form a continuous air flow circuit. A left-right distinguishing mark may also be provided on the front wall 121 of the hollow pipe 12 at the end of the second interface 112. One end of the hollow pipe 12 adjacent to the first interface 111 is larger than the end adjacent to the second interface 112. It should be noted that the patient interface pad 7 may be a nasal mask or nasal pillow that only surrounds the patient's nasal airway, such as Figure 4 and Figure 8 shown, or it may be an oro-nasal mask or full-face mask that simultaneously surrounds the patient's nasal airway and mouth airway, such as Figure 20 、 Figure 21 shown.
[0082] The cross-sectional shapes of the front wall 121 and the rear wall 122 of the hollow pipe 12 can be any combination of square bracket, arc, wavy or flat plate, such as Figure 13 shown. Generally speaking, in order to make the patient feel more comfortable, the position where the rear wall 122 fits the face is usually a plane. In order to ensure the ventilation effect of the frame 1, the front wall 121 and the rear wall 122 cannot both be flat plates, and can be any combination other than this, such as an arc-shaped front wall 121 and an arc-shaped rear wall 122, an arc-shaped front wall 121 and a flat plate-shaped rear wall 122, a wavy front wall 121 and a flat plate-shaped rear wall 122 (which can prevent the front wall 121 from touching the bottom when receiving pressure and affecting the air flow); in order to ensure aesthetics and for production requirements and user comfort, the edges of the front wall 121 and the rear wall 122 should be rounded. The wall thickness of the front wall 121 and the rear wall 122 of the hollow pipe 12 may be uniform or non-uniform. For example, the wall thickness of the inner edge 124 is thinner and the outer edge 125 is thicker, forming a cross-section similar to a shell shape, which can reduce the pressure of the inner edge 124 on the face; or the outer edges 125 are thicker, the front and rear walls 122 are slightly thinner, and the design with thicker sides and thinner middle better supports the space inside the hollow pipe 12 to prevent collapse.
[0083] A support portion 126 is provided on the inner wall 123 of the hollow pipe 12 corresponding to the first interface 111 to prevent the gas delivery device 8 from touching the bottom when the first interface 111 is connected to the gas delivery device 8, thus closing the pressurized air flow. The support portion 126 is a strip-shaped protrusion formed from the inner wall 123 of the hollow pipe 12, such that when the gas delivery device 8 approaches the inner wall 123 of the hollow pipe 12 under the action of gravity, a gap is formed between the support portion 126 and the hollow pipe 12, allowing the air flow to pass through. To ensure the normal functioning of the support portion 126, as Figure 12 shown, regardless of the shape and orientation of the support portion 126, the length of the support portion 126 should be greater than the distance from the first interface 111 to the intersection point of the straight line along which the length of the support portion 126 extends, in order to ensure that the gas delivery device 8 does not touch the bottom. The support portion 126 has another function, that is, for production requirements, the support portion 126 can prevent the product from scratching or piercing through the hollow pipe 12 during production. Multiple support portions 126 can also be provided on the inner wall 123 at other positions of the hollow pipe 12 to prevent the hollow pipe 12 from being squeezed and touching the bottom when lying on its side.
[0084] Fins for fixing the frame 1 to the patient's face using the headband 5, including a first fin 131 provided on the hollow pipe 12 adjacent to the first interface 111, and a second fin 132 provided on the hollow pipe 12 adjacent to the second interface 112. The first fin 131 has at least one opening for connecting the headband 5, and the second fin 132 has at least one opening for connecting the quick-release member 3 or the headband 5. The first fin 131 can be provided in any number that can fix the frame 1, at least one, extending upward from the hollow pipe 12 above the ear; when there is only one first fin 131, it is preferably provided at the outer edge 125 of the hollow pipe 12 corresponding to the first interface 111, extending upward and backward from the head during wearing, and cooperating with the headband 5 to apply a pulling force on the frame 1 upward and backward from the head to prevent the frame 1 from falling off; when there are two first fins 131, they are preferably symmetrically provided on both sides of the first interface 111, which can not only be used to lift the frame 1 but also maintain the contour shape of the frame 1; when there are three first fins 131, they can be provided at the middle and both sides of the first interface 111.
[0085] The first flap 131 has at least one hole for connecting the headband 5 so that when worn, a pulling force towards the back of the head is applied to the frame 1 to prevent the frame 1 from slipping off under the action of gravity; the second flap 132 has at least two and extends from the hollow pipe 12 towards the lower part of the ear for connecting the headband 5 so that when worn, a pulling force towards the back of the head is applied to the frame 1 to pull the patient interface pad 7 closer to the patient's airway. Further, the extending position of the second flap 132 ends at the mandible position to reduce the extrusion on the face when the patient lies on the side. The second flap 132 should have a certain flexibility to deform according to the contour of the face, bringing a more comfortable using experience to the patient. The flap can be directly integrally formed with the hollow pipe 12 or can be formed into an inseparable whole with the hollow pipe 12 by means such as later adhesives; in some forms, the flap can be connected to the hollow pipe 12 in the form of an external part such as a buckle or a ring tube, and the position of the flap can be moved according to the needs of the user. Preferably, the flap is integrally formed with the frame 1. As Figures 5 to 6 shown, Figure 5 The figure shows a schematic diagram of the supine state of the frame assembly when worn. Figure 6 The figure shows a left view of the frame assembly when worn. In the figure, G1 is the gravity of the frame 1, and F1 and F2 are the forces applied to the frame 1 by the headband 5 through the first flap 131. Through Figure 5 it can be seen that when lying supine, the first flap 131 has a force f11 towards the upper part of the head to fix the frame 1 at the forehead position. At the same time, the forehead has an upward supporting force N (not shown in the figure) on the frame 1 to keep the frame 1 relatively balanced at the fixed position. Through Figure 6 the decomposition shows that in the upright state, the first flap 131 has a pulling force f21 towards the back of the head and a pulling force f22 towards the upper part of the head on the frame 1, pulling the frame 1 close to the patient's face and partially offsetting the gravity G1 of the frame 1 to prevent the frame 1 from slipping towards the patient's eyes; the patient interface pad 7 has a gravity G2, F3 is the force applied to the patient interface pad 7 by the headband 5 through the second flap 132, F4 is the force applied to the patient interface pad 7 by the frame 1, f31 and f41 are towards the back of the head, pressing the patient interface pad 7 towards the patient's nose to ensure the sealing effect and prevent the patient interface pad 7 from being blown away from the patient's airway when receiving positive pressure pressurized breathing gas. The direction of f42 is upward to partially offset the gravity G2 of the patient interface pad 7 and f32, reducing the pressure of the patient interface pad 7 on the upper lip area. Through the structure of the position and angle of the flap, the flap and the headband 5 have appropriate pulling forces on the frame 1 to make the frame 1 more stably fixed on the patient's face, and reduce the risk of air leakage of the patient interface pad 7, with a better sealing effect.
[0086] The frame component further includes an automatic adjustment mechanism 14, which is arranged on the hollow pipe 12 adjacent to the first interface 111. Preferably, it is arranged on the hollow pipe 12 adjacent to the first interface 111 and not exceeding the zygomatic bone of the patient, and is used to automatically adjust (automatically deform under the action of gravity or tension) the length or width of the hollow pipe 12 to adapt to the facial contours of different patients. The design that the automatic adjustment mechanism 14 does not exceed the zygomatic bone is to ensure the comfort of the frame component. It is arranged at the forehead position that is not easily squeezed during sleep, effectively avoiding the concave and convex folded walls of the automatic adjustment mechanism 14 from pressing on the face. The automatic adjustment mechanism 14 has a structure that is more easily deformed than the hollow pipe 12, and is composed of a plurality of folded walls made of an elastomer, with a plurality of concave portions 141 and convex portions 142, and the wall thickness is not greater than the wall thickness of the hollow pipe 12. When subjected to the action of gravity or external force, the automatic adjustment mechanism 14 forms a shape of compressing inward and expanding outward; or compressing outward and expanding inward; or compressing / expanding on both sides at the same time. In some embodiments, such as Figure 14 shown, in order to prevent the automatic adjustment mechanism 14 from deforming too easily and causing the frame 1 to be difficult to maintain its shape during wearing, in addition to increasing its hardness, connecting walls 143 can be added at the positions corresponding to the inner edge 124 and the outer edge 125 of the hollow pipe 12 on the automatic adjustment mechanism 14, which are used to connect the concave parts between the multiple folded walls. The connecting walls 143 can prevent the deformation difference between the inner and outer sides from being too large, and can effectively limit the deformation degree of the automatic adjustment mechanism 14. The automatic adjustment mechanism 14 has two sides, one side is hermetically connected to the first interface 111, and the other side is hermetically connected to the hollow pipe 12. Further, the automatic adjustment mechanism 14 is integrally formed with the hollow pipe 12 and is composed of silicone rubber with a Shore hardness of 30A - 70A. In another embodiment, the automatic adjustment mechanism 14 forms an inseparable whole with the hollow pipe 12 through post-processing; in yet another embodiment, the automatic adjustment mechanism 14 is detachably connected to the hollow pipe 12.
[0087] The rigid interface 2, made of a material more rigid than the frame 1, such as polycarbonate, polyamide, ABS, polyvinyl chloride, polyethylene, is provided at the second interface end of the frame 1 and forms a non-removable connection with the second interface 112. The connection with the second interface 112 can be achieved by means such as co-molding, molding, ultrasonic, adhesive, welding, mechanical fasteners, etc. Preferably, the connection method between the rigid interface 2 and the second interface 112 is one of co-molding and welding. The rigid interface 2 can be completely enclosed within the second interface 112 or protrude from the second interface 112. The rigid interface 2 has at least one protrusion or groove for forming a removable connection with the patient interface pad 7. The volume of the rigid interface 2 should be designed to be as small as possible to avoid squeezing the patient's nasal side. In some forms, the frame assembly can be without the rigid interface 2 and be directly connected to the patient interface pad 7 through the second interface 112. At this time, the connection form between the second interface 112 and the patient interface pad 7 can be a frictional fit or a snap fit (constructing the patient interface pad 7 to be snapped into the second interface 112). In another embodiment, the rigid interface 2 can be selectively designed at the wing opening or the first interface 111 position; when the rigid interface 2 is provided at the wing opening, the shape of the wing opening can be maintained to avoid deformation of the wing opening when pulling the headband 5.
[0088] The quick-release member 3 is provided in the opening at one end of the wing away from the hollow pipe 12 and forms a removable connection with the wing. As Figure 11 shown, the quick-release member 3 is in the form of a magnetic buckle or a clip. The patient can choose to use different quick-release members 3 according to personal habits or directly connect the headband 5 to the wing without using the quick-release member 3. The quick-release member 3 and the wing can also form a non-removable connection by means such as gluing. The quick-release member 3 generally consists of two parts. The first part 31 is used to connect the wing, and the second part 32 is connected to the headband 5. It can connect the headband 5 to the frame 1 and can quickly separate the headband 5 from the frame 1, facilitating the patient to wear the frame assembly. To ensure the connection between the headband 5 and the frame 1 during use, the quick-release member 3 should be designed with an anti-detachment mechanism, and when there is no external force or the quick-release member 3 is subjected to a small external force, the force for connecting the first part 31 and the second part 32 of the quick-release member 3 should be greater than the separating force.
[0089] The headband 5 is designed corresponding to the wing of the frame assembly and is at least a three-point headband 5 for fixing the frame 1 on the patient's face and is made of a textile material. The headband 5 is adjustable and is provided with adjustment mechanisms such as Velcro and buckles; it can also be automatically adjusted by an elastic fixing device 51 (such as an elastic band). As Figure 10As shown, preferably, a double-layer elastic fixing device 51 can be provided at the top of the headband 5 for accommodating and fixing the hose of the gas delivery device 8 connected to the frame 1, so as to prevent the hose from moving and knotting or winding during sleep.
[0090] The following describes several structures of the ventilator frame assembly for delivering gas according to the present invention with specific examples.
[0091] Example 1
[0092] A ventilator frame assembly for delivering gas in this embodiment is used to deliver positive-pressure pressurized breathing gas from a flow generator to a patient's airway to treat sleep apnea, such as Figure 1 , Figure 2 , Figure 4 As shown, it includes a frame 1 having a first interface 111 provided on the patient's forehead to receive positive-pressure pressurized breathing gas and a second interface 112 adjacent to the patient's nasal side; the frame 1 further includes two symmetric hollow pipes 12 connecting the first interface 111 provided at the center of the frame 1 and the two second interfaces 112 respectively provided on the patient's nasal side, for delivering positive-pressure pressurized breathing gas from the first interface 111 to the second interface 112. The hollow pipe 12 has a front wall 121, a rear wall 122, and an inner edge 124 and an outer edge 125 formed at the junction of the front wall 121 and the rear wall 122; the frame assembly further includes a quick-release member 3 for connecting the headband 5 and the second flap 132, provided at one end of the second flap 132 away from the hollow pipe 12 and forming a detachable connection with the second flap 132; flaps for connecting the headband 5 to fix the frame 1 on the patient's face, including a first flap 131 extending upward toward the ear from the outer edge 125 of the hollow pipe 12 adjacent to the first interface 111, and a second flap 132 extending downward toward the ear from the outer edge 125 of the hollow pipe 12 adjacent to the second interface 112; an automatic adjustment mechanism 14 provided on the hollow pipe 12 adjacent to the first interface 111 and not exceeding the patient's cheekbone, for automatically adjusting the length or width of the hollow pipe 12 to adapt to the facial contours of different patients.
[0093] Among them, the hollow duct 12 extends upward from the first nasal side of the patient to the first temporal part, then upward to the forehead, and then extends to the second temporal part and then to the second nasal side, forming a contour that at least partially surrounds the patient's eyes and nose. That is to say, the hollow duct 12 starts from the left nasal side of the patient, extends upward to the left temporal part Temporal of the patient, then extends to the center of the forehead, and then extends downward through the right temporal part of the patient and finally returns to the right nasal side of the patient. The contour formed by connecting the points passed by the hollow duct 12 can be connected by straight lines or by smooth curves. It is worth mentioning that setting the center of the frame 1 at the patient's forehead position, including at least 3 headband connection points, can fix the frame 1 more firmly, and the hollow duct 12 has 2 symmetrically arranged connections between the nasal side and the forehead, making the main body of the frame 1 close to the front side of the patient's head, as Figure 7 shown, when the patient lies on the side, the frame 1 avoids protruding parts such as the cheekbones and frontal bones, and is close to the soft parts such as the front side of the face and the cheeks, avoiding the extrusion of the head on the frame 1 to the greatest extent, effectively ensuring the ventilation effect and the comfort of the patient wearing, and the 2 hollow ducts 12 effectively prevent the other duct from still being able to provide ventilation when one duct is accidentally pressed.
[0094] In other embodiments, the hollow duct 12 can also start from the first nasal side (left nasal side), extend upward, pass behind the first ear (left side) of the patient and then wrap around the first temporal part Temporal (left side) of the patient, and then extend downward through the second temporal part (right side) of the patient, pass behind the second ear (right side) of the patient, and finally return to the second nasal side (right nasal side) of the patient; the space surrounded by the hollow duct 12 is not fixed, as long as the ventilation effect and comfort can be ensured.
[0095] Example 2
[0096] A ventilator frame assembly for delivering gas in this embodiment, which is used to deliver positive pressure pressurized breathing gas from a flow generator to a patient's airway to treat sleep apnea, includes a frame 1 made of a continuous hollow elastomer, having a first interface 111 for receiving positive pressure pressurized breathing gas, a second interface 112 adjacent to the patient's nasal side, and a hollow duct 12 extending between the patient's eyes and ears to connect the first interface 111 and the second interface 112; the hollow duct 12 has a front wall 121 away from the patient's face and a rear wall 122 close to the patient's face; flaps for connecting a headband 5 to fix the frame 1 on the patient's face, including a first flap 131 provided on the hollow duct 12 adjacent to the first interface 111, and a second flap 132 provided on the hollow duct 12 adjacent to the second interface 112; an automatic adjustment mechanism 14 provided on the hollow duct 12 for automatically adjusting the hollow duct 12 to adapt to the facial contours of different patients.
[0097] The difference between this embodiment and Embodiment 1 lies in the position of the automatic adjustment mechanism 14. For example, Figure 15 as shown, the automatic adjustment mechanism 14 is arranged adjacent to the second interface 112 and is used to adjust the height distance between the first interface 111 and the second interface 112 to adapt to the heights from the noses to the foreheads of different patients. In another variation, the automatic adjustment mechanism 14 can be arranged at multiple positions with multiple adjustments, providing a higher adaptability to the patient's face. In another embodiment, the automatic adjustment mechanism 14 is not provided on the hollow pipe 12, and the frame 1 can be provided in different sizes to adapt to different patients. Example 3
[0098] A ventilator frame assembly for delivering gas in this embodiment is used to deliver positive-pressure pressurized breathing gas from a flow generator to a patient's airway to treat sleep apnea. For example, Figure 16 as shown, it includes a frame 1, which has a first interface 111 arranged on the patient's forehead to receive positive-pressure pressurized breathing gas, and a second interface 112 adjacent to the patient's nasal side; the frame 1 further includes two symmetrical hollow pipes 12 that connect the first interface 111 arranged at the center of the frame 1 and the two second interfaces 112 respectively arranged on the patient's nasal side, and are used to deliver the positive-pressure pressurized breathing gas from the first interface 111 to the second interface 112. The hollow pipe 12 has a front wall 121, a rear wall 122, and an inner edge 124 and an outer edge 125 formed at the joint of the front wall 121 and the rear wall 122; flaps are used to connect the headband 5 to fix the frame 1 on the patient's face. A first flap 131 that extends upward and backward from the outer edge 125 of the hollow pipe 12 arranged at the center of the frame 1 towards above the ear, and a second flap 132 that extends downward from the outer edge 125 of the hollow pipe 12 adjacent to the second interface 112 towards below the ear. The difference between this embodiment and Embodiment 1 lies in the number and position of the first flap 131. For example, Figure 16 , shown as a side view of the frame assembly in the worn state. In this embodiment, the first flap 131 is located at the center of the frame 1 and extends upward and backward from the outer edge 125 of the hollow pipe 12 towards above and behind the head, giving an upward and backward pulling force to the frame 1 to fix the frame 1 at the forehead position. The second flaps 132 are symmetrically arranged on both sides of the second interface 112, and the points where the flaps are located form an isosceles triangle. The headband 5 extends from the top of the head towards the back of the head, at least partially surrounding the back side of the head, and then extends downward towards below the ear, forming a triangular shape. This design has a smaller area surrounding the head and is more breathable than the four-point headband 5.
[0099] Example 4
[0100] A ventilator frame assembly for delivering gas in this embodiment is used to deliver positively pressurized breathing gas from a flow generator to a patient's airway to treat sleep apnea. It includes a frame 1 made of a continuous hollow elastomer, having a first interface 111 for receiving positively pressurized breathing gas, a second interface 112 adjacent to the patient's nasal side, and a hollow pipe 12 extending between the patient's eyes and ears to connect the first interface 111 and the second interface 112; the hollow pipe 12 extends upward from the patient's first nasal side to the first temporal region and then extends to the second temporal region and then to the second nasal side, forming a contour that at least partially surrounds the patient's eyes and nose; the frame assembly further includes a connecting member 4. As Figure 17 shown, the connecting member 4 is disposed between a rigid interface 2 and a patient interface pad 7, having a first end connecting the rigid interface 2 and a second end connecting the patient interface pad 7, forming a detachable connection with the rigid interface 2 and the patient interface pad 7. The shape and size of the first end of the connecting member 4 correspond to those of the rigid interface 2, and the shape and size of the second end correspond to those of the patient interface pad 7. This means that the first ends of different connecting members 4 are invariant, while the second ends can be designed according to the interfaces of the required patient interface pads 7, so as to achieve the form that the same frame 1 is adapted to patient interface pads 7 with different interfaces, improving the designability of the patient interface pad 7. For example, for a patient interface pad 7 with a snap-type male / female head, the connecting member 4 is also set in a corresponding form; for a patient interface pad 7 with a magnetic or rotary interface, it can also be adapted by changing the second end of the connecting member 4 without modifying the frame 1, and only the connecting member 4 needs to be replaced. At the same time, the connecting member 4 can also carry more functions, such as adjusting the width of the frame 1, connecting members 4 with different lengths; adding additional functions, setting an oxygen interface, a temperature detector, a pressure detector, etc., to implement the detection of the pressurized air flow situation; and also setting an anti-asphyxia valve to connect a patient interface pad 7 including a mouth-nose type.
[0101] Example 5
[0102] A ventilator frame assembly for delivering gas in this embodiment is used to deliver positive-pressure pressurized breathing gas from a flow generator to a patient's airway to treat sleep apnea. It includes a frame 1 made of a continuous hollow elastomer, having a first interface 111 for receiving positive-pressure pressurized breathing gas, a second interface 112 adjacent to the patient's nose, and a hollow pipe 12 extending between the patient's eyes and ears to connect the first interface 111 and the second interface 112; flaps for connecting a headband 5 to fix the frame 1 on the patient's face, including a first flap 131 provided on the outer edge 125 of the hollow pipe 12 adjacent to the first interface 111, and a second flap 132 provided on the outer edge 125 of the hollow pipe 12 adjacent to the second interface 112, wherein the first interface 111 penetrates the front wall 121 of the hollow pipe 12, and the second interface 112 penetrates the rear wall 122 of the hollow pipe 12. In this embodiment, there is only one second interface 112 for connecting to a patient interface pad 7, and there are several connection methods with the patient interface pad 7. One is that a rigid interface 2 is provided on the second interface 112 to form a detachable connection with the patient interface pad 7 through the rigid interface 2; the other is that the patient interface pad 7 has a part made of a hard material, slightly larger than the second interface 112, and the patient interface pad 7 is fixed by the deformable characteristic of the second interface 112 made of an elastomer. In this embodiment, exhaust holes may be provided on the front wall 121 of the hollow pipe 12 corresponding to the second interface 112 to facilitate the discharge of waste gas when the patient is receiving treatment.
[0103] Example 6
[0104] A ventilator frame assembly for delivering gas in this embodiment is used to deliver positive-pressure pressurized breathing gas from a flow generator to a patient's airway to treat sleep apnea. It includes a frame 1 made of a continuous hollow elastomer, having a first interface 111 for receiving positive-pressure pressurized breathing gas, a second interface 112 adjacent to the patient's nose side, and a hollow pipe 12 extending between the patient's eyes and ears to connect the first interface 111 and the second interface 112; flaps for connecting a headband 5 to fix the frame 1 on the patient's face, including a first flap 131 provided on the hollow pipe 12 adjacent to the first interface 111, and a second flap 132 provided on the hollow pipe 12 adjacent to the second interface 112; a comfort layer 6 provided on at least part of the rear wall 122 of the hollow pipe 12, fitting the patient's face. This embodiment adds a comfort layer 6 compared to Comparative Example 1. As Figure 19As shown, since the frame component fits the patient's face during use, it will exert a certain pressure on the patient's face and may cause red marks on some users. Therefore, a comfort layer 6 is provided on the rear wall 122 of the part where the hollow pipe 12 fits the face. The comfort layer 6 can be one or more of textile materials and foam materials. Its main function is to improve the wearing comfort and increase the air permeability of the frame component. The comfort layer 6 can absorb water and sweat better and bring a better user experience to the patient. In another variant, the comfort layer 6 can be made of a gel material that is softer than the frame. The comfort layer 6 can be externally mounted on the frame 1, for example, fixed at the required position by Velcro, buckles, double-sided tape, peelable glue, etc.; it can also be provided on the frame 1 by gluing, hot pressing, ultrasonic bonding, etc.; or it can be integrally formed with the frame 1 by molding.
[0105] Implementing the ventilator frame component for delivering gas of the present invention has at least the following beneficial effects:
[0106] 1. The frame component of the present invention is more stable compared with the existing similar type of frame with a pipe but with the air inlet provided on the patient's head. For the pipe frame of the prior art, when the patient is lying on their back, it is prone to fall off under its own gravity and the pulling force of the gas delivery device, thus prying the patient interface pad and causing air leakage and other situations; while the frame 1 of the present invention covers the patient's face, and the central air inlet 111 of the frame 1 is provided on the patient's forehead. In the supine state, the patient's forehead has an upward supporting force on the frame 1, making it not easy for the center of the frame 1 to slide off under the action of gravity, resulting in displacement of the patient interface pad 7 and causing air leakage. And the gas interface of the frame 1 is provided on the patient's face, and the patient can judge the position of the gas interface through a mirror, which is easier to install gas delivery devices 8 such as elbows than the prior art with the interface provided on the headband 5. At the same time, the frame 1 is provided with an automatic adjustment mechanism 14, which can automatically adjust according to the patient's face shape under the dual action of gravity and pulling force when the patient wears it, and better fit the patient's facial contour.
[0107] 2. The frame component of the present invention has at least 3 headband connection points, which is less likely to leak air compared to the existing 2 connection points of the pipeline frame. For the pipeline frame in the prior art, there are only 2 pulling forces towards the back of the head on the frame above the ears, which cannot ensure that the frame will not slide down; and when the patient is in the supine position, the pulling force of the headband on the frame towards the back is more likely to pull the frame 1 off the top of the head; at the same time, there is no additional pulling force around the patient interface pad. If the patient lies on their side, the patient interface pad is very likely to deviate from the predetermined position and deviate from the patient's airway. However, the frame 1 of the present invention has at least 3 points of pulling force. One is to apply a force towards the upper and rear of the head above the frame 1 to ensure that the frame 1 will not slide down under the action of gravity, and the upper part of the frame 1 can fit the patient's face; the other is two pulling forces towards the back of the head near the nasal side of the frame 1, making the frame 1 fit the face more closely and indirectly applying a force close to the nose to the patient interface pad 7. At the same time, at least 3 headband connection points can wrap the head in all directions, making it more stable and ensuring that the changes in the user's body turning over and facial muscles during sleep have the least impact on the frame component and the patient interface pad 7. And the headband 5 is provided with an elastic fixing device 51, which can fix the breathing tube on the patient's head, further enhancing the stability and reliability of the treatment component. At the same time, placing the gas delivery device 8 on the head and fixing it with the headband 5 can effectively prevent the breathing tube from falling off or winding around the patient. For the convenience of disassembly, the frame component is also provided with a quick release member 3, allowing the patient to quickly separate the frame 1 and the headband 5 through the quick release member 3, making it more convenient to wear without repeatedly adjusting the length of the headband 5.
[0108] 3. The air flow of the frame component of the present invention is smoother. Compared with the design of the existing type of pipeline frame extending from the patient's nasal side to the top of the head, although the pipeline in the prior art avoids the vertex of the cheekbone, it still passes through the bones on the side of the patient's head. When the patient lies on their side, it is very easy to squeeze one side of the pipeline, affecting the air flow into the patient's airway and also affecting the comfort of sleep. However, the frame 1 of the present invention is mainly placed in the front position of the patient's face, avoiding the protruding bones, such as the cheekbone and the frontal bone. In this way, when the patient lies on their side, it will be the relatively soft position of the face - the cheek contacts the frame 1, which is not easy to squeeze the pipeline and can ensure the smoothness of the air flow during the treatment process to the greatest extent.
[0109] 4. The frame component of the present invention also comes with a connecting member 4. By replacing the connecting member 4, the same frame 1 can be connected to patient interface pads 7 of different interface types, allowing patients to choose a suitable patient interface pad 7. For example, a patient interface pad 7 with a male head can be paired with a connecting member 4 with a female head, and conversely, a patient interface pad 7 with a female head can be paired with a connecting member 4 with a male head. In this way, without changing the frame 1 and the patient interface pad 7, the two can be adapted to each other, and only by replacing a small part can the modular effect be achieved, which is a better choice for both producers and patients; producers can be not limited to designing patient interface pads 7 that interface with the frame 1 and have more room for pioneering designs; patients can also choose to use patient interface pads 7 of different types, structures, and functions. At the same time, the adaptation of multiple frames 1 to multiple patient interface pads 7 is also beneficial to the environment. Designing and replacing the connecting member 4 alone means less consumption of raw materials, can effectively protect existing resources and promote sustainable energy use, less production waste, and reduced carbon emissions and climate change.
[0110] 5. Compared with the prior art non-pipeline type frames that seal around the patient's airway, the frame component of the present invention has a larger contact area with the face and is made of an elastomer, which can effectively distribute the pressure brought by the headband 5, exert less pressure on the face, and will not squeeze the patient. At the same time, compared with the prior art, the gas interface of the frame component of the present invention is placed at a position farther away from the patient's face, which can avoid the exhaust flow from affecting the patient's sleep and reduce the patient's perception of noise.
[0111] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope recorded in this specification.
[0112] The above-described embodiments only represent several implementation manners of the present invention. The description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the present invention patent should be subject to the appended claims.
Claims
1. A ventilator frame assembly for delivering gas, which is used to deliver positive-pressure pressurized breathing gas from a flow generator to a patient's airway to treat sleep apnea, comprising: A frame having a first interface disposed on a patient's forehead to receive positively pressurized breathing gas and a second interface adjacent to the patient's nasal side; The frame further includes two symmetric hollow conduits connecting the first interface disposed at the center of the frame and the two second interfaces respectively disposed on the patient's nasal sides for delivering positively pressurized breathing gas from the first interface to the second interfaces. The hollow conduits have a front wall, a rear wall, and inner and outer edges formed at the junction of the front wall and the rear wall; Flaps for connecting a headband to fix the frame on the patient's face, including a first flap disposed at the outer edge of the hollow conduit adjacent to the first interface and a second flap disposed at the outer edge of the hollow conduit adjacent to the second interface; Wherein, the hollow conduits extend upward from the first nasal side of the patient to the first temporal region, then upward to the forehead and then extend to the second temporal region to the second nasal side, forming a contour at least partially surrounding the patient's eyes and nose.
2. The ventilator frame assembly for delivering gas according to claim 1, wherein The flaps are integrally formed with the frame and are made of silicone with a Shore hardness of 30A - 70A.
3. The ventilator frame assembly for delivering gas according to claim 1, wherein The first flap has at least one opening for connecting a headband, and the second flap has at least one opening for connecting a quick release member.
4. The ventilator frame assembly for delivering gas according to claim 1, wherein The frame assembly further includes an automatic adjustment mechanism disposed on the hollow conduit adjacent to the first interface for automatically adjusting the length or width of the hollow conduit to adapt to the facial contours of different patients.
5. A ventilator frame assembly for delivering gas, which is used to deliver positive-pressure pressurized breathing gas from a flow generator to a patient's airway to treat sleep apnea, comprising: A frame having a first interface disposed on a patient's forehead to receive positively pressurized breathing gas and a second interface adjacent to the patient's nasal side; The frame further includes two symmetric hollow conduits connecting the first interface disposed at the center of the frame and the two second interfaces respectively disposed on the patient's nasal sides for delivering positively pressurized breathing gas from the first interface to the second interfaces. The hollow conduits have a front wall, a rear wall, and inner and outer edges formed at the junction of the front wall and the rear wall; Flaps for connecting a headband to fix the frame on the patient's face, including a first flap disposed at the outer edge of the hollow conduit adjacent to the first interface and a second flap disposed at the outer edge of the hollow conduit adjacent to the second interface; A rigid interface for forming a detachable connection with a patient interface pad, disposed at the second interface end of the frame and forming a non - detachable connection with the second interface.
6. The ventilator frame assembly for delivering gas according to claim 5, wherein The frame assembly further includes a quick release member for connecting a headband and the second flap, disposed at the end of the second flap away from the hollow conduit and forming a detachable connection with the second flap.
7. The ventilator frame assembly for delivering gas according to claim 5, wherein The connection mode of the rigid interface and the second interface is one of co - molding and welding.
8. The ventilator frame assembly for delivering gas according to claim 5, wherein The rigid interface has at least one protrusion for connecting with a patient interface pad.
9. A ventilator frame assembly for delivering gas, which is used to deliver positive-pressure pressurized breathing gas from a flow generator to a patient's airway to treat sleep apnea, comprising: A frame made of a continuous hollow elastomer, having a first interface for receiving positively pressurized breathing gas, a second interface adjacent to the patient's nasal side, and a hollow conduit extending between the patient's eyes and ears to connect the first interface and the second interface; Flaps for connecting a headband to fix the frame on the patient's face, including a first flap disposed on the hollow conduit adjacent to the first interface and a second flap disposed on the hollow conduit adjacent to the second interface; The first flap has at least one that extends upward from the hollow conduit towards the ear and has at least one hole for connecting a headband so as to apply a pulling force towards the rear of the head to the frame when worn; The second flap has at least two that extend downward from the hollow conduit towards the ear and are used to connect a headband so as to apply a pulling force towards the rear of the head to the frame when worn to pull the patient interface pad closer to the patient's airway; A support portion is provided on the inner wall of the hollow conduit corresponding to the first interface to prevent the gas delivery device from touching the bottom and closing the pressurized air flow when the first interface is connected to the gas delivery device.
10. The ventilator frame assembly for delivering gas according to claim 9, wherein The first interface has an annular wall extending into the inner cavity of the hollow conduit for enhancing the connection and sealing with the gas delivery device.
11. The ventilator frame assembly for delivering gas according to claim 9, wherein The hollow conduit has a front wall away from the patient's face and a rear wall close to the patient's face, wherein the first interface penetrates the front wall of the hollow conduit.
12. The ventilator frame assembly for delivering gas according to claim 9, wherein, The hollow conduit extends upward from the first nasal side of the patient to the first temporal region and then extends to the second temporal region and then to the second nasal side, forming a contour that at least partially surrounds the patient's eyes and nose.
13. The ventilator frame assembly for delivering gas according to claim 9, wherein, The support portion is a strip-shaped protrusion formed from the inner wall of the hollow conduit, and the length of the support portion should be greater than the distance of the intersection point of the first interface and the straight line along which the length direction of the support portion extends.
14. A ventilator frame assembly for delivering gas, configured to deliver positive pressure pressurized breathing gas from a flow generator to a patient airway to treat sleep apnea, comprising: A frame having a first interface for receiving positive-pressure pressurized breathing gas and a second interface adjacent to the patient's nasal side; The frame further includes two symmetrical hollow conduits connecting the first interface provided at the center of the frame and the two second interfaces respectively provided on the patient's nasal sides for delivering positive-pressure pressurized breathing gas from the first interface to the second interface. The hollow conduit has a front wall, a rear wall, and an inner edge and an outer edge formed at the junction of the front wall and the rear wall; An automatic adjustment mechanism is provided on the hollow conduit adjacent to the first interface and not exceeding the patient's cheekbone for automatically adjusting the length or width of the hollow conduit to adapt to the facial contours of different patients; Flaps for connecting a headband to fix the frame on the patient's face, including a first flap extending upward from the outer edge of the hollow conduit adjacent to the first interface towards the ear, and a second flap extending downward from the outer edge of the hollow conduit adjacent to the second interface towards the ear, wherein the second flap has at least one opening for connecting a quick-release member or a headband; Wherein, the hollow conduit extends upward from the first nasal side of the patient to the first temporal region and then extends to the second temporal region and then to the second nasal side, forming a contour that at least partially surrounds the patient's eyes and nose.
15. The ventilator frame assembly for delivering gas according to claim 14, wherein, The automatic adjustment mechanism is composed of a plurality of folded walls made of an elastomer and has a plurality of recesses and protrusions.
16. The ventilator frame assembly for delivering gas according to claim 14, wherein, The front wall of the hollow conduit is arc-shaped and the rear wall is flat.
17. The ventilator frame assembly for delivering gas according to claim 14, wherein, The quick-release member is in the form of a magnetic buckle or a clip.
18. The ventilator frame assembly for delivering gas according to claim 14, wherein, One end of the hollow conduit adjacent to the first interface is larger than one end adjacent to the second interface.
19. A ventilator frame assembly for delivering gas, configured to deliver positive pressure pressurized breathing gas from a flow generator to a patient airway to treat sleep apnea, comprising: A frame made of a continuous hollow elastomer, having a first interface provided on the patient's forehead for receiving positive-pressure pressurized breathing gas, a second interface adjacent to the patient's nasal side, and a hollow conduit extending between the patient's eyes and ears to connect the first interface and the second interface; An automatic adjustment mechanism, disposed on the hollow pipe adjacent to the first interface, for automatically adjusting the length or width of the hollow pipe to adapt to the facial contours of different patients; A rigid interface, made of a material more rigid than the frame, disposed at the second interface end of the frame, and forming a non-detachable connection with the second interface; Flaps, for connecting the headband to fix the frame on the patient's face, including a first flap disposed on the outer edge of the hollow pipe adjacent to the first interface, and a second flap disposed on the outer edge of the hollow pipe adjacent to the second interface; Wherein, the hollow pipe extends upward from the first nasal side of the patient to the first temporal part, then upward to the forehead, and then extends to the second temporal part to the second nasal side, forming a contour at least partially surrounding the patient's eyes and nose.
20. The ventilator frame assembly for delivering gas according to claim 19, wherein, The automatic adjustment mechanism is integrally formed with the hollow pipe and is composed of silicone with a Shore hardness of 30A - 70A.
21. The ventilator frame assembly for delivering gas according to claim 19, wherein, The frame assembly further includes a connecting member, the connecting member having a first end connecting the rigid interface and a second end connecting the patient interface pad, and forming a detachable connection with the rigid interface and the patient interface pad.
22. The ventilator frame assembly for delivering gas according to claim 21, wherein, The shape and size of the first end of the connecting member correspond to the rigid interface, and the shape and size of the second end correspond to the patient interface pad.