A pressure sore prevention non-invasive respirator mask

Abstract

The present application relates to a pressure ulcer prevention non-invasive respirator mask, comprising a buffer piece. The buffer piece comprises a curvature part. The contact surface of the curvature part, which bears the pressure of the respirator mask, is provided with a concave surface with an arc-shaped profile. Under the action of pressure from the respirator mask, the side edges of the concave surface expand towards both ends of the respirator mask to reduce the pressure of the respirator mask on the patient's face. The curvature part of the present application has a partial symmetrical "U" shape and a curved hem shape in cross section. When under pressure, the concave surface is first squeezed, and then the two side edges are stressed and the stress is equal, thereby avoiding disordered deformation of the edge of the respirator mask in the transverse and / or longitudinal directions, and also avoiding gas leakage inside the respirator mask. The curvature part of the present application is applied between the respirator mask and the patient's skin, thereby reducing the squeezing effect of the respirator mask on the patient's face, avoiding gas leakage inside the respirator mask, and enhancing the sealing of the respirator mask.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and particularly relates to a pressure sore prevention non-invasive respirator mask. BACKGROUND

[0002] Non-invasive respirators are used in clinical treatment of sleep apnea syndrome and related diseases. The blood oxygen saturation, sympathetic nerve tension, parasympathetic nerve tension, blood carbon dioxide concentration, PH value and intrathoracic negative pressure caused by these diseases are decreased, increased, decreased, increased and increased, respectively, which seriously affect the functions of various important organs, especially the brain function and cardiovascular function. Non-invasive respirators generally refer to respirator treatment devices through nasal masks or face masks. Since the patients do not need to be intubated or cut open the trachea, the operation is simple, the patients are easy to accept, and the damage and respiratory machine related pneumonia and other complications are less. Non-invasive respirators are not only widely used in the treatment of acute or chronic respiratory failure inpatients, but also increasingly used in the home application of outpatients with stable conditions.

[0003] Existing medical institutions generally use a quarter respirator mask. The respirator controls the gas flow into the respirator mask. The respirator realizes gas exchange through the conversion of positive pressure and negative pressure, which makes the respirator mask must be close to the patient's skin to prevent air leakage. Due to the diversity of human face size, the respirator mask cannot correctly adapt to the face shape of each patient, so there may be leakage between the respirator mask and the patient's face. Especially for the quarter respirator mask, the probability of air leakage is greater. If the face matching between the respirator mask and the wearer is not proper, the respirator mask cannot achieve good respiratory care effect in actual use.

[0004] How to make the respirator mask adapt to the patient's face to reduce the air leakage of the respirator, how to prevent the respirator mask from applying excessive pressure to the patient's face to form pressure sores, and how to prevent pressure sores while meeting the fit of the respirator mask to apply appropriate force to the patient's skin are problems that need to be solved in the prior art

[0005] Chinese patent CN 114904113A discloses a respirator mask, belonging to the field of medical devices, comprising a mask body, the mask body is provided with a nose part, the respirator mask further comprises a pressure sensor and an air guide tube, the pressure sensor is installed on the mask body, one end of the air guide tube is connected with the pressure sensor, and the other end is connected with the nose part of the mask body, so that the air guide tube is close to the human nostrils, the pressure sensor directly measures the pressure change generated by human respiration through the air guide tube, reduces the interference of the respirator gas supply pressure, so as to accurately identify the start and end of the inhalation and exhalation actions according to the pressure signal in the respirator mask, and then realize the respirator gas supply control, effectively improve the man-machine synchronicity of the respirator gas supply, and the patent also relates to a respirator gas supply control method implemented by the above respirator mask. The patent focuses on the pressure change inside the respirator mask, but it is difficult to avoid pressure ulcers on the patient's face caused by the respirator mask in the case of pressure change.

[0006] Chinese patent CN 114949510A discloses a non-invasive respirator mask applied to ICU, comprising a mask body, a nasogastric tube access rack, a nasogastric tube access port and a sealed control plug, the outer surface of the mask body is fixedly connected with the nasogastric tube access rack, the lower surface of the nasogastric tube access rack is provided with two nasogastric tube access ports, and the other side of the nasogastric tube access port is arranged on the inner surface of the mask body. By setting the nasogastric tube access rack, if the nasogastric tube needs to be used, the front end position of the nasogastric tube is passed through the nasogastric tube access port and enters the inside of the nasogastric tube access rack, and the inside outlet position of the nasogastric tube access rack is inserted into the patient's nasal cavity position. Compared with the traditional respirator mask through which the nasogastric tube is accessed from the side, the respirator mask adds a structure for passing through the gastric tube, and when the nasogastric tube is accessed, the respirator mask still maintains the original fit, so that air leakage does not occur.

[0007] However, the defects of this patent are that although the pressure change in the respirator mask and the air leakage are considered and solved, the solution is limited to changing the gas supply mode of the respirator, thereby indirectly realizing pressure control and gas exchange. For patients, this relatively passive control method cannot guarantee the smooth implementation of pressure control, and the air leakage and pressure ulcers still cannot be avoided. How to simultaneously solve the problems of air leakage and pressure ulcers is the focus that the above two patents have not considered.

[0008] In addition, on the one hand, there are differences in the understanding of those skilled in the art; on the other hand, a large number of literatures and patents have been studied by the applicant when making the present application, but due to the limitation of space, all the details and contents have not been listed in detail, which does not mean that the present application does not have these characteristics of the prior art, on the contrary, the present application has all the characteristics of the prior art, and the applicant reserves the right to add relevant prior art in the background art. SUMMARY

[0009] In view of the deficiencies of the prior art, the present application provides a pressure sore prevention non-invasive respirator mask, comprising: a buffer member arranged at the position where the respirator mask contacts the patient's skin and used for buffering the pressure of the respirator mask, the buffer member comprising: a curvature portion extending from the inside of the respirator mask towards the outside to form a structure covering the edge of the respirator mask, wherein the contact surface of the curvature portion subjected to the pressure of the respirator mask is provided with at least one concave surface with an arc-shaped profile, and based on the pressure effect of the pressure of the respirator mask, the side edges of the concave surface expand towards both ends inside and outside the respirator mask to reduce the pressure intensity of the respirator mask on the patient's face.

[0010] According to a preferred embodiment, the curvature portion extends smoothly from the position where the respirator mask contacts the patient's skin and points to the outer shell of the respirator mask in a curvature turning manner. In the case where the curvature portion is extruded by the pressure of the respirator mask, the curvature portion is filled with fluid to extrude the respirator mask and increase the acting force between the curvature portion and the respirator mask. The design is to form a contact area capable of deforming along the vertical edge direction by connecting the buffer member with the supporting surface at the contact part of the respirator mask and the patient's skin, and to reduce the pressure on the patient's face by a certain curvature turning, so that the edge of the respirator mask does not deform along the edge direction due to the change of air pressure. The case where the curvature portion is extruded by the pressure of the respirator mask refers to the use of the respirator mask. The increase of the acting force between the curvature portion and the respirator mask refers to the change of the increase value by adjusting the frequency and / or capacity of the fluid filling and discharging.

[0011] According to a preferred embodiment, the two side edges of the concave surface constituting the curvature portion are arranged in a symmetrically curved manner so that when the concave surface is subjected to pressure, the two side edges deform symmetrically to avoid irregular deformation of the edge of the respirator mask in the transverse and / or longitudinal direction and fill the gap between the curvature portion and the respirator mask. The curvature portion has multiple advantages. When the supporting surface inside the respirator mask shrinks under the influence of internal air pressure difference to buffer the sudden pressure change, since the curvature portion is streamlined and has a certain curvature, it can uniformly disperse the changing pressure to the edge of the respirator mask and will not deform irregularly, so that the edge of the respirator mask will not have the problem of air leakage, and also will not have the problem of local pressure process causing pressure sores.

[0012] When the buffer piece bears pressure, different degrees of regular changes can be made based on the changes in the pressure, with the patient's skin contact surface as the core, so that the form of the buffer piece does not change unbalancedly. Specifically, since the curvature part of the buffer piece is filled with buffer gas and the outside forms a hem-like structure, when the curvature part is affected by pressure, the pressure is weakened and its direction of action is limited by the buffer gas and the hem-like structure in turn, so that the edge of the ventilator mask does not appear gap-like deformation, preventing the ventilator mask from leaking air, and at the same time, the extrusion of the curvature part also makes the contact area with the patient's skin larger, thereby preventing pressure sores on the patient's face.

[0013] According to a preferred embodiment, a deformation space capable of communicating with the curvature part to fill fluid into the curvature part is formed inside the ventilator mask, wherein a gas valve for inflating and deflating is connected to the deformation space, and in the case that the curvature part is extruded by the ventilator mask pressure, the gas valve inflates towards the curvature part to make the side edges on both sides of the extruded concave surface expand to limit the force direction of the ventilator mask pressure on the concave surface.

[0014] According to a preferred embodiment, the inner angle of the opening formed by the vertical highest point of the two side edges symmetrical to the axis of the concave surface and the vertical lowest point of the concave surface towards the vertical upward direction ranges from 90° to 180°, so that the two side edges cover the edge of the ventilator mask when the concave surface is under pressure.

[0015] According to a preferred embodiment, it further comprises a pressure sensor for detecting the pressure inside the ventilator mask. A processor is in communication with the pressure sensor and the gas valve, wherein the processor controls the gas valve to adjust the contraction or expansion degree of the deformation space based on the pressure feedback from the pressure sensor to maintain the pressure in the ventilator mask.

[0016] According to a preferred embodiment, the gas valve is connected to the deformation space, and when the pressure inside the ventilator mask changes, the processor adjusts the contraction of the deformation space according to the feedback of the pressure sensor, so that the pressure inside the ventilator mask returns to the corresponding value. During the patient's breathing process, the gas valve is used to lock the pressure state to make the ventilator mask fit the patient's skin.

[0017] According to a preferred embodiment, during the positive pressure ventilation process of the breathing cycle of the breathing machine, the pressure sensor measures the pressure change at a first frequency and compares it with the preset positive pressure ventilation pressure. The processor controls the air valve to inflate the deformation space to supplement the pressure based on the comparison result, wherein the processor controls the input or output of the fluid in the deformation space based on the change of the pressure difference between the pressure in the breathing machine mask and the preset pressure until the pressure in the breathing machine mask and the preset pressure achieve numerical balance.

[0018] The prior art breathing machine maintains high pressure during inhalation and low pressure during exhalation, and the patient's normal breathing or time determines the conversion of high and low pressure, and the gas enters and exits by generating a pressure difference, but the repeated and sudden change of air pressure can easily cause damage to the patient's mask, especially after long-term use, the breathing machine mask can cause pressure sores on the patient's face or cause air leakage problems. The present application alleviates the sudden change of pressure to a certain extent by setting the air valve, support surface and support ridge, and in the case of accumulation of carbon dioxide exhaled by the patient causing an increase in pressure inside the breathing machine mask, the internal pressure of the breathing machine mask is self-adaptively adjusted to prevent pressure sores on the patient's face and the problem of easy air leakage caused by the sudden change of air pressure.

[0019] According to a preferred embodiment, the processor controls at least one of the plurality of air valves to inflate or deflate based on a preset time period to cause at least one of the deformation spaces corresponding to the curvature to expand or shrink to prevent the occurrence of facial pressure sores in a segmented manner to alleviate the pressure on the patient's face.

[0020] According to a preferred embodiment, the processor is further configured to change the filling frequency and / or filling degree of the fluid in the curvature in a manner that reduces the discomfort of the patient's face based on the active activation behavior of the user to periodically adjust the filling and discharging fluid frequency and / or filling and discharging fluid capacity of at least one of the deformation spaces. BRIEF DESCRIPTION OF DRAWINGS

[0021] Figure 1 is a simplified structure diagram of a pressure sore prevention non-invasive breathing machine mask according to a preferred embodiment of the present application;

[0022] Figure 2 is a simplified structure cross-sectional view of a pressure sore prevention non-invasive breathing machine mask according to a preferred embodiment of the present application;

[0023] Figure 3 is a structure diagram of the cross section of the curvature according to a preferred embodiment of the present application;

[0024] Figure 4Fig. 7 is a structural schematic diagram of a cross section of the curvature portion under pressure extrusion according to a preferred embodiment of the present application.

[0025] List of reference signs

[0026] 1: support ridge; 2: support surface; 3: breathing machine mask; 4: deformation space; 5: pressure sensor; 6: buffer; 7: curvature portion; 8: concave surface; 9: side edge. DETAILED DESCRIPTION

[0027] The present application will be described in detail below with reference to the accompanying drawings.

[0028] Example 1

[0029] In the prior art, there are mainly three types of breathing machine masks:

[0030] First, a quarter mask. It covers the mouth and nose, and the sealing surface of the mask is designed to be between the chin and lower lip of the patient.

[0031] Second, a half mask. It covers the nose, mouth and chin of the patient. The sealing performance of the half mask is more reliable.

[0032] Third, a full mask. It covers the hairline to the chin of the patient. This type of breathing machine mask can achieve good sealing around the patient's face without affecting the normal communication of the patient. This type of breathing machine mask is also used to protect the patient's glasses.

[0033] The first type of mask is commonly used in medical facilities for assisted breathing of patients. The ventilator controls the flow of gas into the mask. The ventilator achieves gas exchange by switching between positive and negative pressure, which makes it necessary for the mask to be tightly fitted to the patient's skin to prevent air leaks. Due to the variety of human face sizes, the mask cannot properly fit every patient's face shape, and air leaks can occur between the mask and the patient's face. This is especially true for the first type of mask described above. If the mask and the wearer do not properly fit together, the mask can not provide the best respiratory care during actual use. To address this, masks are often tested quantitatively or qualitatively to provide the most suitable mask for the patient. In the qualitative test described above, medical personnel have the wearer test several sizes of masks to determine which mask best fits the wearer's face shape and provides air leak protection and pressure sore protection by providing a proper sealing element between the wearer and the mask. Generally, the qualitative test requires less time, does not require complex and expensive equipment, and is easy to perform on site. However, the qualitative test has the disadvantage that the test relies on the subjective feelings of the wearer, making the results of the test not completely reliable. In addition, in the qualitative test, a mask that the wearer feels comfortable with can not provide sufficient sealing. For example, when the wearer has a beard, when the wearer gains weight, or when the mask is worn out. Quantitative tests also include negative pressure tests. In a negative pressure test, the air inlet of the mask is closed, and the mask slightly collapses when the tester inhales. The tester holds their breath for about 10 seconds. If the mask remains slightly collapsed and no outward leakage is detected, the mask and the tester have sufficient fit. The positive pressure test is very similar to the negative pressure test, with the same advantages and disadvantages. The positive pressure test is performed by closing the air inlet of the mask and by the tester gently exhaling into the mask. If a slight positive pressure can be established inside the mask without any outward leakage, the mask and the tester have sufficient fit. Both the positive and negative pressure tests have the disadvantage that the test is subjective for the tester. For example, the testers testing the mask do not breathe at the same pressure. Thus, one tester can think the mask meets the requirements, while another tester does not.

[0034] As described above, this simple test method has serious disadvantages due to the influence of subjective factors and non-quantitative nature. For example, the use in the test environment is significantly different from the use in the patient's sick condition, and the breathing intensity is also different.

[0035] How to make the respirator mask fit the patient's face to reduce the respirator leakage, how to prevent the respirator mask from excessive pressure on the patient's face to form pressure sores, and how to prevent pressure sores while meeting the respirator mask fit to apply appropriate force on the patient's skin are problems that need to be solved in the prior art.

[0036] Therefore, the present application provides a pressure sore prevention non-invasive respirator mask, at least comprising: a plurality of support ridges 1 and support surfaces 2 connected with the support ridges 1. The support surfaces 2 form the inner shell of the respirator mask 3. Preferably, the support ridges 1 extend from the highest point of the respirator mask 3 to the place where the respirator mask 3 contacts the patient's skin. The above-mentioned highest point refers to the highest point of the convex of the respirator mask 3. The design of the support ridges 1 and the support surfaces 2 can reduce the pressure on the patient's skin when the respirator mask 3 is in use. Specifically, the outer shell of the respirator mask 3 contacting the outside world is composed of a plastic shell, and the inside of the shell is also provided with a plurality of support ridges 1 and a plurality of support surfaces 2. The support surfaces 2 are connected only by the support ridges 1. The support surfaces 2 can be made of rubber molding material. Preferably, the plurality of support ridges 1 are used to maintain the suction of the support surfaces 2 on the patient's skin. Preferably, at least two support ridges 1 support the two sides of the support surface 2. Preferably, at least three support ridges 1 are arranged along the semi-circular shape of the support surface 2 to divide the support surface 2 into at least three arc-shaped sectors. For example, the included angle between the three support ridges 1 is the same, so that the semi-circular support surface 2 is equally divided into three arc-shaped sectors, and the contact of the three arc-shaped sectors with the patient's skin realizes the relief of pressure. Preferably, under the support of the plurality of support ridges 1, the support surface 2 is divided into a plurality of arc-shaped sectors, and the fit or away of the arc-shaped sectors with the respirator mask shell forms the respirator mask 3 with corresponding changes in internal negative pressure. For example, the plurality of arc-shaped sectors shrink inwardly to form a negative pressure state inside the respirator mask 3, so as to fit the patient's skin. Preferably, the support ridges 1 can also be provided with a pressure sensor 5. Preferably, the edge of the arc-shaped sector of the support surface 2 is flat to fit the patient's skin. The present application provides partial rigidity by the support ridges 1 and partial flexibility by the support surface 2, which can ensure the fit with the patient's skin while preventing excessive pressure from forming pressure sores on the patient's face. The arc-shaped sectors of the support surface 2 are deformable, while the other parts are not deformable to keep the respirator mask 3 in the corresponding shape. When the patient is assisted in breathing, the arc-shaped sectors of the support surface 2 continuously perform repeated actions of contraction and recovery to limit the pressure change inside the respirator mask 3 in a certain threshold manner, thereby preventing pressure sores from occurring on the patient's face. The certain threshold refers to the limit threshold of the contraction and expansion of the arc-shaped sectors of the support surface 2, which changes the size of the internal space of the respirator mask 3 through the contraction and expansion of the arc-shaped sectors, thereby adjusting the internal air pressure change, and the adjustment threshold of the internal air pressure, i.e. the limit threshold of the contraction and expansion of the arc-shaped sectors.

[0037] The respirator mask currently used in the prior art is often made of silicone material to prevent pressure sores on the patient's face. However, the flexibility of the silicone material is poor, which can easily cause air leakage at the edge of the respirator mask, causing respiratory disorders and the respirator mask to fall off the patient's skin. In addition, the internal pressure of the respirator mask cannot be adjusted, and the comfortable adsorption force cannot be applied to the patient's face, which can easily cause discomfort or pressure sores on the patient's face. To this end, the prior art can also use soft rubber at the patient's contact position, but the adsorption of the soft rubber is poor, which can easily cause uncontrollable deformation during respiration. Uncontrollable deformation causes uneven distribution of internal pressure in the respirator mask, resulting in air leakage.

[0038] Specifically, the following describes an example of the prior art using soft rubber at the patient contact position. The deformation of the soft rubber causes the internal pressure of the respirator mask to change the force point at the edge of the respirator mask, which changes the horizontal or vertical stress direction of the soft rubber and increases the deformation of the soft rubber, thereby causing air leakage. When the air pressure in the respirator mask is less than the external atmospheric pressure, the respirator mask is adsorbed on the patient's skin, and because the soft rubber of the respirator mask has elasticity, it is easy to produce displacement towards the inside of the respirator mask under the pressure difference and appear displacement deformation, especially the soft rubber in contact with the patient's skin will deform and appear a gap connected to the outside, thereby causing air leakage of the respirator mask. In addition, when the soft rubber is attached to the patient's skin, the force on the soft rubber is not necessarily the same, which causes the soft rubber to not maintain its original profile after the respirator mask is attached to the patient's skin. Due to the change in profile, the symmetry of the respirator mask will also change, and the asymmetric change of the respirator mask will change the pressure point, so that the adsorption force is no longer uniformly distributed on the respirator mask, causing the soft rubber to deform more severely. Based on the above defects, the prior art adds a stretchable band around the patient's head to firmly fix the respirator mask to the patient's face, thereby solving the problem of air leakage caused by changes in the force state, but this also causes the respirator mask to easily cause pressure sores on the patient's face. In addition, the tangential deformation of the respirator mask edge can also easily cause the edge to be sharp and cause damage to the patient.

[0039] Preferably, the support surface 2 is provided with a cushion 6 at the part in contact with the patient's skin. Preferably, the cushion 6 can be one of an external silicone pad or an inflatable bladder pad, preferably an inflatable bladder pad. The cushion 6 comprises a curvature 7 extending outwardly. The curvature 7 extends outwardly and gradually points to the respirator mask shell. Wherein the curvature 7 presents a shape of extending outwardly smoothly from the part of the respirator mask in contact with the patient's skin and then turning with a curvature to point to the respirator mask shell. The design is to form a contact area capable of deforming along the vertical edge direction by the cushion 6 connected with the support surface 2 at the part of the respirator mask in contact with the patient's skin, and to reduce the pressure on the patient's face by turning with a curvature, and also to make the respirator mask edge not to deform along the edge direction due to the change of air pressure. The above-mentioned turning with a curvature refers to the curvature of the curvature 7 to form a curled edge structure pointing to the respirator mask shell with a certain curvature radius.

[0040] As Figure 2 shown in the cross-sectional shape of the cushion 6. The above-mentioned curvature with a certain curvature refers to the curvature range in which the curvature 7 can make the streamline bend to form a curled edge height less than one fourth of the height of the respirator mask after bending.

[0041] Preferably, the buffer 6 is preferably an inflatable cushion, which reduces the pressure on the patient's face by the buffer of internal gas. Preferably, the curvature 7 of the buffer 6 has an inwardly bent hem-like structure, which further reduces the pressure of the ventilator mask on the patient's face. The curvature 7 is streamlined, and the hem height formed after the streamlined bending is less than one fourth of the height of the ventilator mask, so as to prevent excessive deformation of the edge. Preferably, the curvature 7 gradually relieves the pressure load on the patient's face under the action of pressure after the ventilator mask is pressed. Preferably, the inflatable cushion forming the curvature 7 buffers the pressure load on the patient's face by internal gas. Preferably, the hem-like structure of the curvature 7 is gradually flattened under the action of pressure, thereby increasing the pressure area of the edge of the ventilator mask and the patient's face to reduce the pressure on the patient's face, thereby preventing pressure sores on the patient's face. When the hem height formed after the streamlined bending is close to one fourth of the height of the ventilator mask, the buffer effect that can be generated is sufficient to reduce the possibility of pressure sores on the patient's face by more than 70%. The buffer 6 connected with the support surface 2 has many advantages. When the support surface 2 in the ventilator mask shrinks under the influence of internal pressure difference to buffer sudden pressure changes, since the buffer 6 is streamlined and has a certain curvature, it can uniformly disperse the changing pressure to the edge of the ventilator mask, and there is no irregular deformation, so that the edge of the ventilator mask does not have the problem of air leakage, and also does not have the problem of local pressure process to cause pressure sores. When the buffer 6 bears pressure, it can change regularly in different degrees based on the change of the pressure, with the patient's skin contact surface as the core, so that the shape of the buffer 6 does not change unbalancedly. Specifically, since the curvature 7 of the buffer 6 is filled with buffer gas inside and has a hem-like structure outside, when the curvature 7 is affected by pressure, the pressure is weakened and limited in its direction of action by the buffer gas and the hem-like structure in turn, so that the edge of the ventilator mask does not have a gap-like deformation, preventing air leakage of the ventilator mask, and the extrusion of the curvature 7 also makes the contact area with the patient's skin larger, thereby preventing pressure sores on the patient's face.

[0042] The present application uses the streamlined buffer 6 to prevent irregular deformation of the edge of the ventilator mask, and to make the pressure on the edge of the ventilator mask similar, thereby avoiding air leakage of the ventilator mask under pressure changes. The streamlined buffer 6 has smaller pressure on the patient's face, and does not form sharp structures, so as not to easily cause pressure sores and injuries on the patient's face, or shorten the service life of the ventilator mask due to edge deformation.

[0043] As Figure 3 and Figure 4As shown, a buffer is positioned at the contact point between the ventilator mask and the patient's skin to cushion the pressure from the ventilator mask. A curved portion extends from the inside of the ventilator mask outwards to form a structure that covers the edge of the ventilator mask. The contact surface of the curved portion that bears the pressure from the ventilator mask has at least one concave surface with an arc-shaped profile. Based on the pressure applied by the ventilator mask, the sides of the concave surface expand towards both the inner and outer ends of the ventilator mask to reduce the pressure of the ventilator mask on the patient's face. Figure 3 and Figure 4 The shape of the broken cross section of the curvature section is shown only for illustration.

[0044] The cross-section of the curved portion exhibits a locally symmetrical structure at the point where the ventilator mask contacts the patient's skin. Figure 4 The dashed line is the median line of symmetry for a locally symmetrical part of the curvature. For example... Figure 4 As shown, the curved surface that contacts the ventilator mask has at least one arc-shaped concave surface 8. The included angle formed by the sides 9 of the two concave surfaces, which are locally symmetrical about the central axis of the concave surface 8, is greater than 90 degrees. The opening formed by the line connecting the highest vertical point of the two sides 9 about the central axis of the concave surface 8 and the lowest vertical point of the concave surface has an interior angle ranging from 90° to 180° in the vertically upward direction, so that when the concave surface 8 is under pressure, the two sides 9 cover the edge of the ventilator mask.

[0045] Preferably, the concave surface is streamlined, and its lowest point in contact with the ventilator mask is located on the central axis. Preferably, the two sides of the concave surface constituting the curvature portion are arranged in a symmetrically curved manner. Preferably, the concave surface in contact with the ventilator mask is at least made of a non-ductile material. Preferably, the concave surface can also be configured such that a contact portion made of a non-ductile material is provided at the contact surface with the ventilator mask. Preferably, the remaining portion of the curvature portion, excluding the concave surface, is made of a ductile material. The cross-sectional profile of the concave surface is an arc with a certain curvature. Preferably, when the curvature portion is pressurized, the valve inflates at least into the curvature portion so that the two sides of the concave surface expand towards the inner and outer ends of the ventilator mask under pressure, thereby limiting the deformation of the ventilator mask edge under pressure and distributing the pressure evenly to all points where the curvature portion contacts the patient's skin. Preferably, when the curvature portion is inflated, at least a portion of the curvature rotation unfolds to increase the contact area with the patient's skin. Preferably, when the curvature portion is inflated, at least a portion of the curvature rotation portion can also be used to prevent the sharp edges of the curvature portion from contacting the patient's skin and to increase the local rigidity of the curvature portion.

[0046] The curvature part has multiple advantages. When the concave surface contacts the pressure of the respirator mask, the concave surface at the contact surface is symmetrical, which can uniformly disperse the pressure of the respirator mask to the remaining side surfaces, and the curvature of the concave surface is arranged so that the respirator mask does not deform irregularly. When the concave surface bears the pressure of the respirator mask, the concave surface can deform in different degrees and locally symmetrically based on the extrusion of the pressure, so that the edges of the respirator mask do not deform irregularly with one end small and the other end large. The advantage of the material of the concave surface is that, by designing the curvature part with good ductility and the concave surface with poor ductility, when the curvature part is inflated, the concave surface under the pressure of the respirator mask can resist the pressure with a certain rigidity, and the remaining curvature part gradually expands and expands to contact the patient in the inflated state, and covers and holds up the inner and outer ends of the respirator mask in contact with the concave surface, preventing the gas in the respirator mask from escaping, and avoiding air leakage of the respirator.

[0047] Specifically, under the action of the pressure of the respirator mask on the curvature part, the pressure application part is limited in the application direction of the pressure due to the arrangement of the concave surface, and the pressure is uniformly applied to each position of the curvature part through the two side edges. The pressure does not irregularly extrude the curvature part and make the lowest point of the concave surface be extruded first, and then the curvature part slowly and locally symmetrically deforms. When the curvature part deforms based on the pressure, the curvature part can be filled with fluid to make the part with good ductility expand, that is, the two side edges expand and cover the edges of the inner and outer ends of the respirator mask, thereby avoiding the phenomenon of air leakage of the respirator mask.

[0048] The curvature part has a local symmetrical "U" shape and a curved and curled shape in cross section. When pressed, the concave surface is first extruded, and then the two side edges are stressed and the stress is equal, thereby avoiding disordered deformation of the edges of the respirator mask in the transverse and / or longitudinal directions, and also avoiding leakage of gas in the respirator mask. The curvature part is applied between the respirator mask and the skin of the patient, thereby reducing the extrusion of the respirator mask on the face of the patient, avoiding leakage of gas in the respirator mask, and enhancing the sealing property of the respirator mask.

[0049] Example 2

[0050] This embodiment is a further improvement of Example 1, and repeated contents will not be described again.

[0051] According to a preferred embodiment, the cushion 6 can be coated with a disinfecting or moisturizing substance. Preferably, the disinfecting substance, such as a disinfecting fluid, disinfects the cushion 6 and the outer edge by coating. The moisturizing substance is, for example, an adhesive with high viscosity, thereby reducing the displacement of the ventilator mask caused by patient movement and preventing air leakage from the ventilator mask. Preferably, the moisturizing substance is, for example, a paste. In some embodiments, the paste can provide better skin contact with the patient during long-term use of the ventilator mask, such as reducing friction between the ventilator mask and the patient's skin, compared to a wet gel that can dry during use. Preferably, the paste can include one or more of the following ingredients: polyoxyethylene cetyl ether, water, glycerin, 1,2-propanediol, gel, polyoxyethylene sorbitol, methyl paraben, and propyl paraben. The above-described dressing prevents facial pressure injuries caused by non-invasive ventilator masks and increases the fit of the non-invasive ventilator mask and the face, preventing air leakage.

[0052] Example 3

[0053] This embodiment is a further improvement of the above-described embodiments, and repeated content will not be described again.

[0054] The above-described embodiments illustrate the method and principle of using the ventilator mask of the present application for assisted breathing, but the prior art is prone to carbon dioxide accumulation during patient breathing, resulting in high pressure in the mask and causing harm to the patient's mask. At the same time, oxygen cannot enter the inside of the ventilator mask well, and exhaled carbon dioxide cannot be flushed out to the outside of the ventilator mask. In addition, due to the large air flow in the ventilator mask, the incoming oxygen is also severely diluted.

[0055] According to a preferred embodiment, a pressure sensor 5 is further arranged on the support ridge 1 to detect the pressure inside the respirator mask. Preferably, a gas valve is further arranged on the respirator mask and connected to the support surface 2. The support surface 2 is arranged inside the respirator mask and, together with the support ridge 1, forms a deformation space 4 arranged inside the respirator mask and capable of freely deforming. The gas valve is connected to the deformation space 4 to adjust the contraction of the deformation space 4 according to the feedback of the pressure sensor 5 when the pressure inside the respirator mask changes, so that the pressure inside the respirator mask remains unchanged. When the pressure inside the respirator mask remains unchanged, oxygen can enter the respirator mask more quickly to flush out carbon dioxide outside the respirator mask. Preferably, the respirator continuously supplies oxygen at a constant pressure during the patient's exhalation and inhalation cycle. Preferably, the processor adjusts the contraction or expansion of the deformation space 4 according to the pressure requirements through the feedback from the pressure sensor 5 to maintain the pressure in the respirator mask. The deformation space is different from the curvature part, which is not extruded but on the inner wall of the respirator mask. The above is the deformation of the curvature part extruded by the respirator mask. The deformation of the extruded curvature part is changed by the contraction or expansion of the deformation space. Preferably, the gas valve is used to lock its pressure state to make the respirator mask closely fit the patient's skin when the patient is breathing. Preferably, when the respirator provides respiratory support at a preset pressure based on a preset respiratory rate per unit time, the processor controls the gas valve to repeat the cycle according to the preset respiratory control gas to be delivered per unit time. Preferably, the processor controls the contraction or expansion of the deformation space 4 according to the preset increased or decreased pressure cycle to achieve the required inhalation and exhalation cycle of the patient. Preferably, the gas delivered to the patient changes the pressure of the respirator mask, which is measured at a high rate by the pressure sensor 5. The high rate is, for example, measured at a frequency of 6 ms. Preferably, the pressure change detected by the pressure sensor 5 is repeatedly fed back to the processor. The processor determines the feedback of the pressure sensor 5 to change the inflation or deflation of the gas valve and correspondingly change the way the expansion or contraction of the deformation space 4 maintains the pressure within the preset level. The unit time can be one minute.

[0056] The present application can adaptively adjust the pressure change inside the respirator mask through the arrangement of the gas valve, the support surface 2 and the support ridge 1, including corresponding pressure adjustment under different assisted breathing modes of the respirator, thereby relieving the pressure on the patient's face and preventing pressure ulcers. At the same time, when the pressure is insufficient, it can be supplemented to prevent the respirator mask from falling off or leaking.

[0057] According to a preferred embodiment, the ventilator applies preset pressure levels during inspiratory positive airway pressure (IPAP) and expiratory positive airway pressure (EPAP) when the ventilator is synchronized with the patient's breathing cycle. Preferably, during the positive pressure ventilation process of the breathing cycle, the pressure sensor 5 measures the pressure change at a first frequency and compares it with the preset positive pressure ventilation pressure. If the measured pressure is lower than the preset pressure, the processor controls the air valve to supplement the pressure. After the pressure is supplemented, the ventilator synchronously increases the oxygen flow rate to enter the patient's lungs. Preferably, the processor and the pressure sensor 5 quickly repeat the feedback loop until the pressure detected by the pressure sensor 5 is consistent with the preset pressure. Preferably, after the pressure detected by the pressure sensor 5 is consistent with the preset pressure, the pressure sensor 5 measures the pressure change at a second frequency. The first frequency can be 0.1 s / time. The second frequency can be 0.4 s / time.

[0058] Specifically, to determine the rate of change of pressure, the pressure sensor 5 can take several pressure measurements with an interval of 6.125 milliseconds. By measuring the numerical difference between these consecutive pressure readings, it can be determined that the patient's normal breathing cycle has changed significantly at a certain time, for example, at the end of the patient's exhalation or inhalation action. Preferably, when the threshold of the rate of change of pressure is APa, which changes by 6.125 ms interval, if the measured rate of change of pressure is equal to or greater than APa, it indicates that the cycle is ending, and the patient's state changes from inhalation ventilation to exhalation ventilation (i.e., the end of the inhalation cycle) or from exhalation ventilation to inhalation ventilation (i.e., the end of the exhalation cycle). The pressure set points of the inspiratory ventilation and expiratory ventilation parts in the breathing cycle can be 25-35 cm-H2O and 5 cm-H2O. The ventilator in the prior art maintains high pressure during inhalation and low pressure during exhalation, and the patient's normal breathing or time determines the conversion of high and low pressure, and the gas enters and exits by generating a pressure difference, but the repeated and sudden changes in air pressure can cause damage to the patient's mask, especially after long-term use, the ventilator mask can cause pressure sores on the patient's face or cause air leakage problems. The present application alleviates the sudden change of pressure to some extent by setting the air valve, the support surface 2 and the support ridge 1, and in the case of accumulation of carbon dioxide exhaled by the patient, the internal pressure of the ventilator mask is self-adaptively adjusted to prevent pressure sores on the patient's face and the problem of easy air leakage caused by the sudden change of air pressure.

[0059] According to a preferred embodiment, when the ventilator is used to augment the natural breathing rhythm of a patient, the pressure sensor 5 detects an abnormal increase in pressure within the ventilator mask, indicating the presence of carbon dioxide buildup within the ventilator mask. The ventilator is provided with a means for monitoring the tidal volume of gas supplied to the patient. It is important to ensure that sufficient tidal volume is delivered to the patient in order to prevent the buildup of carbon dioxide in the patient's blood. If the tidal volume is insufficient, it can lead to carbon dioxide buildup in the patient, and can also lead to respiratory acidosis, and in severe cases, respiratory failure. Preferably, the ventilator applies a pre-set pressure level during the inspiratory positive airway pressure (IPAP) and expiratory positive airway pressure (EPAP). Preferably, during the positive pressure ventilation of the breathing cycle, the pressure sensor 5 measures the pressure change at a first frequency and compares it to the pre-set positive pressure ventilation pressure. Preferably, a flow sensor in the ventilator measures the rate of flow to the patient, and the pressure and flow values are integrated to establish a volume rate. The integration process is delayed by a lag time when the pressure of the ventilator during the inspiratory positive airway pressure and expiratory positive airway pressure reaches the pre-set value. After a certain period of time (e.g. 0.3 seconds), the pressure sensor 5 cycles. Preferably, the processor determines whether the volume rate change exceeds a pre-determined threshold. Preferably, if the resulting volume rate change does not exceed the pre-determined threshold, the pressure sensor 5 cycles again. If the resulting volume rate change exceeds the pre-determined threshold, it indicates the end of the cycle, and the patient's condition changes from inspiratory ventilation to expiratory ventilation (i.e. the end of the inspiratory cycle) or from expiratory ventilation to inspiratory ventilation (i.e. the end of the expiratory cycle). Preferably, during each cycle, the tidal volume of the incoming gas is calculated based on the average value per unit time. Preferably, the processor combines and averages all the measurements of the previous minute. If the average value per unit time is below the pre-set target level required, the pressure setting is increased and the cycle is repeated until the gas flow to the patient reaches the pre-set target level. If the average value per unit time exceeds the pre-set target level required, the pressure setting is decreased. Preferably, when the pressure sensor 5 measures a pressure that is below or above the desired set point, the processor controls the gas valve to inflate or deflate the shape-changing space 4 to change the pressure within the ventilator mask, thereby decreasing or increasing the gas flow to the patient until the desired set value is reached. It is noted that although the tidal volume is calculated several times per second, the individual measurements are accumulated over a period of time, preferably one minute, and the processor only responds to the average tidal volume over that time period to make the correction. Thus, transient changes in the patient's breathing action do not immediately trigger a pressure response.

[0060] The system and method of the present application can continuously, instantaneously respond to changes in pressure of the respirator mask or changes in patient status in any of several operating states of the respirator. The air valves of the present application can enhance spontaneous breathing of the patient. If the patient's spontaneous breathing is not sufficient to maintain the respiratory environment, for example, lacking sufficient tidal volume and proper respiratory rate, the processor controls the air valves to increase activity. The respirator mask of the present application is a relatively minor modification over prior art masks, providing pressure cushioning and other benefits with relatively minor structural changes by the provision of air valves, support surfaces 2 and support ridges 1.

[0061] According to a preferred embodiment, the processor controls at least one of the air valves to inflate or deflate based on a predetermined time period to cause the curvature portion corresponding at least one of the deformation spaces to expand or contract to segmentally relieve pressure on the patient's face to prevent the occurrence of pressure sores. Since the plurality of support ridges and support surfaces of the present application form a plurality of deformation spaces, each of which is independent of the others. The present application inflates and deflates the corresponding deformation space by at least one air valve on the deformation space. Since each deformation space is located differently, during inflation, the closer to the curvature portion of the deformation space has a higher fluid flow rate and volume, so that the local curvature portion near the inflated deformation space has high stiffness under the action of high flow. Pressure sores on the patient's face are caused by long-term pressure, and the present application cyclically inflates and deflates in a plurality of deformation spaces, so that the pressure on the patient's face follows the inflation and deflation changes, so that the patient's face is segmentedly pressed, preventing long-term pressure on a certain area of the patient's face.

[0062] According to a preferred embodiment, the processor is further configured to change the filling frequency and / or the filling degree of the fluid in the curvature portion in a manner that the filling and discharging fluid frequency and / or the filling and discharging fluid volume of at least one morphing space is adjusted periodically based on the active activation of the user to reduce the discomfort of the patient's face. The periodicity can be the partial discharging and filling of the fluid in a manner that conforms to the patient's breathing frequency. When the patient feels uncomfortable, the air valve can be activated periodically by the user to change the filling frequency and / or the volume of the fluid in the curvature portion by actively activating the keys or other interactive components on the processor, so that the rigidity and flexibility of the curvature portion changes with the change of the filling frequency and / or the volume of the fluid, thereby relieving the discomfort of the patient's face. Similarly, medical staff can activate the keys or other interactive components on the processor to change the filling frequency and / or the volume of the fluid in the curvature portion in a manner that conforms to the development trend of the patient's condition, thereby adjusting the buffering of the pressure on the patient's face. The filling frequency and / or the volume of the fluid means the change of the fluid parameters in the curvature portion, i.e. the change of the filling frequency and / or the filling degree of the fluid in the curvature portion. For example, the processor controls the air valve to fill the curvature portion with 30% of the fluid, so that the curvature portion has flexibility while maintaining support for the ventilator mask, thereby relieving the pressure on the patient's face. The above-mentioned 30% refers to 30% of the fluid required for the curvature portion to be fully filled. For another example, the processor controls the air valve to keep the fluid in the curvature portion between 30% and 50% of the fully inflated volume. When the patient exhales, the air valve discharges to reduce the fluid in the curvature portion to 30%, and when the patient inhales, the air valve fills to increase the fluid in the curvature portion to 50%. Due to the patient's breathing, the ventilator needs to perform corresponding assisted breathing, thereby changing the air pressure difference between the inside and outside of the ventilator mask. For the exhalation process, the air pressure difference decreases, and the excess support force is not maintained, thereby reducing the partial fluid in the curvature portion. For the inhalation process, the air pressure difference increases, and the rigidity of the curvature portion is increased to support the ventilator mask, thereby reducing the pressure sores on the patient's face and preventing air leakage of the ventilator mask. The active activation refers to the behavior of the user actively triggering the keys or other interactive components on the processor, and also includes triggering the processor by language or by body movement. The active activation of the present application enables medical staff and patients to participate in the adjustment process of the curvature portion, and the combination of the self-feeling of the patient and the condition judgment of the medical staff with the mechanical control manner further relieves the discomfort of the patient's face and prevents the occurrence of pressure sores.

[0063] It should be noted that the processor can be implemented by a general central processing unit (CPU), an application specific integrated circuit (ASIC), a microprocessor, or one or more integrated circuits, etc. to execute related instructions or programs to realize the technical solutions of the present application.

[0064] Throughout the specification, "preferably", "particularly preferred", and "preferably" or "particularly preferred" are used to describe a preference for a feature, state, or result. It is to be understood that these terms are not to be taken in an exclusive sense but are descriptive of only one embodiment of the application, and hence, applicants reserve the right to drop or omit any of the described preferred features, states, or results.

[0065] It should be noted that the above-mentioned embodiments illustrate rather than limit the application, and that one skilled in the art will be able to devise modifications and alternatives that are within the scope of the application. The disclosure of the application therefore should not be limited to the described embodiments. It will be understood by those within the art that, in general, terms used herein, and especially, terms of degree such as "comprises", "comprising", "as consisting of" and "consisting essentially of" are used herein to convey the intended meaning of "comprising" unless otherwise indicated by context. Thus, it will be understood by those within the art that, in general, terms used herein, and especially, terms of degree such as "comprises", "comprising", "as consisting of" and "consisting essentially of" are used herein to convey the intended meaning of "comprising" unless otherwise indicated by context. Thus, it will be understood by those within the art that, in general, terms used herein, and especially, terms of degree such as "comprises", "comprising", "as consisting of" and "consisting essentially of" are used herein to convey the intended meaning of "comprising" unless otherwise indicated by context. Thus, it will be understood by those within the art that, in general, terms used herein, and especially, terms of degree such as "comprises", "comprising", "as consisting of" and "consisting essentially of" are used herein to convey the intended meaning of "comprising" unless otherwise indicated by context. Thus, it will be understood by those within the art that, in general, terms used herein, and especially, terms of degree such as "comprises", "com

Claims

1. A pressure ulcer-preventing non-invasive ventilator mask, characterized in that, The application relates to a breathing mask cushioning device, comprising: a cushioning part (6) arranged at a position where the breathing mask contacts the skin of a patient and used for cushioning the pressure of the breathing mask, the cushioning part (6) comprising: a curvature part (7) extending from the inside of the breathing mask to the outside to form a structure covering the edge of the breathing mask, wherein the contact surface of the curvature part (7) bearing the pressure of the breathing mask is provided with at least one concave surface (8) with an arc-shaped contour, based on the pressure of the breathing mask exerted on the face of the patient, the side edges (9) of the concave surface (8) expand towards both ends of the inside and outside of the breathing mask to reduce the pressure intensity of the breathing mask on the face of the patient; the curvature part (7) extends outward from the position where the breathing mask contacts the skin of the patient and is directed to the shell of the breathing mask in a curvature turning manner, the curvature turning refers to the curvature part forming a curled edge structure directed to the shell of the breathing mask outside the breathing mask with a curvature radius, the certain curvature refers to the curvature range in which the curled edge height formed after the bending of the curvature part (7) is less than one fourth of the height of the breathing mask; in the case that the curvature part (7) is extruded by the pressure of the breathing mask, the curvature part (7) is filled with fluid to extrude the breathing mask and increase the interaction force between the curvature part (7) and the breathing mask; the curvature part (7) has a local symmetrical "U" shape and a curved curled edge shape in the cross section, the concave surface is extruded first when being pressed, and the two side edges are stressed and the stress is equal, so that the irregular deformation of the edge of the breathing mask in the transverse and / or longitudinal directions is avoided, and the gas leakage in the inside of the breathing mask is also avoided.

2. The pressure ulcer prevention non-invasive ventilator mask of claim 1, wherein, the two side edges (9) of the concave surface (8) of the curvature part (7) are arranged in a symmetrical bending manner, so that when the concave surface (8) is pressed, the two side edges (9) are deformed symmetrically to avoid the irregular deformation of the edge of the breathing mask in the transverse and / or longitudinal directions and fill the gap between the curvature part (7) and the breathing mask.

3. The pressure ulcer prevention non-invasive ventilator mask of claim 1, wherein, a deformation space (4) is formed in the inside of the breathing mask and can communicate with the curvature part (7) to fill the curvature part (7) with fluid, wherein the deformation space (4) is connected with a gas valve for inflation and deflation, in the case that the curvature part (7) is extruded by the pressure of the breathing mask, the gas valve inflates the curvature part (7) to make the side edges (9) on both sides of the extruded concave surface (8) expand to limit the force direction of the breathing mask pressure on the concave surface (8).

4. The pressure ulcer prevention non-invasive ventilator mask of claim 1, wherein, the inner angle of the opening formed by the connection line of the vertical highest points of the two side edges (9) and the vertical lowest point of the concave surface (8) with the axis of the concave surface (8) as the symmetrical line is in the range of 90-180 degrees, so that when the concave surface (8) is in the pressed state, the two side edges (9) cover the edge of the breathing mask.

5. The pressure ulcer prevention non-invasive ventilator mask of claim 3, wherein, the application further comprises: a pressure sensor (5) used for detecting the pressure in the inside of the breathing mask, a processor in communication connection with the pressure sensor (5) and the gas valve, wherein The processor controls the gas valve to adjust the contraction or expansion of the deformation space (4) based on pressure feedback from the pressure sensor (5) to maintain the pressure in the respirator mask.

6. The pressure ulcer prevention non-invasive ventilator mask of claim 5, wherein, The gas valve is connected to the deformation space (4) to adjust the contraction of the deformation space (4) according to the feedback of the pressure sensor (5) when the pressure in the respirator mask changes, so that the pressure in the respirator mask is adjusted to the corresponding value, wherein, The gas valve is used to lock the pressure state to make the respirator mask fit the skin of the patient during the breathing process of the patient.

7. The pressure ulcer prevention non-invasive ventilator mask of claim 6, wherein, During the positive pressure ventilation process of the respirator in the breathing cycle, the pressure sensor (5) measures the pressure change at a first frequency and compares it with the preset positive pressure ventilation pressure; The processor controls the gas valve to inflate the deformation space (4) to supplement the pressure based on the comparison result, wherein the processor controls the input or output of the fluid in the deformation space (4) based on the change of the pressure difference between the pressure in the respirator mask and the preset pressure until the pressure in the respirator mask and the preset pressure achieve numerical balance.

8. The pressure ulcer prevention non-invasive ventilator mask of claim 7, wherein, The processor controls at least one of the plurality of gas valves to inflate or deflate based on a preset time period to make the curvature part (7) corresponding at least one of the deformation spaces (4) expand or contract to prevent the occurrence of facial pressure ulcers in a segmented manner to relieve the pressure on the face of the patient.

9. The pressure ulcer prevention non-invasive ventilator mask of claim 8, wherein, The processor is further configured to: Change the filling frequency and / or filling degree of the fluid in the curvature part (7) in a manner that periodically adjusts the filling and discharging fluid frequency and / or filling and discharging fluid capacity of at least one of the deformation spaces (4) based on the active activation behavior of the user to reduce the discomfort of the patient's face.

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