Patient interface pad applied to CPAP field

Abstract

A patient interface pad for use in the field of CPAP and for delivering a breathable pressurized gas to a patient to treat sleep breathing disorders, comprising a rigid portion and an elastic portion, wherein the elastic part is divided into an elastic part main body and a connecting part, the elastic part main body is at least partially in contact with the face of a patient and forms sealing during use, the connecting part is connected with the rigid part, and the elastic part main body is provided with a plurality of areas, so that different areas of the patient interface pad have different change degrees; the patient interface pad is used for adjusting pressure generated by the patient interface pad on the face in different areas of the face, and specifically comprises an adjusting area used for being compatible with different patient face sizes, nose heights and widths, a supporting area used for supporting the patient interface pad and a stabilizing area used for preventing the patient interface pad from turning outwards at an opening facing the patient. Wherein the adjustment region may be provided with a nasal-side adjustment portion that makes the patient interface pad further compatible with the patient's nose.

Description

Technical Field

[0001] The present invention relates to a patient interface pad for a CPAP that delivers breathable pressurized gas to a patient. The patient interface pad includes a rigid portion and an elastic portion. The elastic portion body has a plurality of regions such that different regions of the patient interface pad have different degrees of variation to adjust the pressure exerted by the patient interface pad on different regions of the face. It is applicable to one or more of the diagnosis, treatment, and improvement of respiratory diseases and is also related to procedures for preventing respiratory diseases. Background Art

[0002] Sleep apnea syndrome (SAS), also known as sleep apnea hypopnea syndrome, is a common syndrome in modern society. Sleep apnea syndrome can occur in anyone, regardless of age, gender, or race, and can affect almost anyone. It is very common globally. According to data from the World Health Organization, as of 2022, more than one billion people worldwide are troubled by sleep apnea syndrome, and the number is still on the rise, which may be related to population aging and the increasingly unhealthy lifestyle of humans. Although sleep apnea syndrome can occur in anyone, there are differences in the incidence between men and women and among different age groups. Generally, men are more likely to develop the disease and it is more common in people aged middle-aged and above. Sleep apnea syndrome is currently classified into obstructive sleep apnea (OSA), central sleep apnea (CSA) caused by central nervous lesions, and mixed sleep apnea (MSAS) that combines both symptoms. Obstructive sleep apnea is the most common type. Common symptoms of obstructive sleep apnea include loud and irregular snoring during sleep, intermittent short awakenings, dry mouth and sore throat due to airway obstruction, drowsiness and extreme sleep deprivation due to sleep interruption and poor sleep quality. Its most common symptom is apnea during sleep, and the apnea can last from more than ten seconds to several minutes. Obstructive sleep apnea can also cause many complications that disrupt people's lives. For example, patients with obstructive sleep apnea are very likely to suffer from cardiovascular diseases such as hypertension, arrhythmia, myocardial infarction, and heart failure, and may also suffer from diabetes and lung diseases. Obstructive sleep apnea affects patients' lives through its nocturnal symptoms and complications, covering multiple aspects such as health, economy, productivity, traffic safety, sleep, and mental health. If obstructive sleep apnea occurs, patients should be treated or improved to reduce its impact on life and other aspects.

[0003] The treatment methods for patients with moderate and severe obstructive sleep apnea generally involve the use of a ventilator, and an essential component thereof is the patient interface pad. The patient interface pad is configured to fit the patient's face. During use, one end is connected to the air delivery tube or elbow, and the other end contacts and seals the patient's face to send the continuous positive airway pressure airflow for maintaining the patient's airway patency into the patient's nasal airway or oral airway. Due to the large demand for patient interface pads, there are already patient interface pads of different styles and models in the existing market. However, the existing patient interface pads still need improvement in various aspects. For example, the existing patient interface pads cause a sense of compression on the patient's face, and marks such as indentations and red marks are likely to occur, especially in the areas of tight fit, when wearing the patient interface pad for a long time. They cannot fit the facial contours and sizes of all patients, cannot fit the nose heights and widths of all patients, and are not clean enough. However, there is no patient interface pad in the existing market that can solve the above problems and provide a better wearing result for patients.

[0004] In view of the above problems of the patient interface pad, through continuous research and innovation, the present invention designs a patient interface pad that solves the above problems, provides a better patient interface pad for patients, and has more advantages in terms of wearing comfort, sealing performance, adaptability and compatibility, and cleaning compared with the existing patient interface pads. It is a more competitive product in the existing patient interface pad market, which can help patients better accept CPAP treatment and ensure the continuity of treatment and patient compliance. Summary of the Invention

[0005] The objective of the present invention is to provide a new type of patient interface pad, which can provide a more comfortable wearing experience for patients, provide higher guarantee for the effectiveness of the treatment of sleep apnea, and overcome the limitations of similar products in the prior art. Thus, it provides a more effective treatment method than the prior art, with a wider application scenario and space, and can deliver the pressurized gas output by the ventilator to the patient's airway in a more convenient way to provide treatment for sleep disordered breathing.

[0006] A patient interface pad applied in the CPAP field, used to deliver breathable pressurized gas to a patient for treating sleep disordered breathing. The patient interface pad includes:

[0007] A rigid part, having an air inlet opening for receiving breathable pressurized gas and being arranged to be connected to an elastic part at one end;

[0008] An elastic part, integrally formed with the rigid part, including an elastic part main body that at least partially contacts the patient's face and forms a seal during use and a connecting part that forms a connection with the rigid part;

[0009] Wherein the elastic part main body has at least three different wall thicknesses, at least including:

[0010] An adjustment region, having an opening close to the patient's face and an edge portion adjacent to the opening, wherein at least a part of the wall thickness of the edge portion adjacent to the opening does not exceed 0.6 mm;

[0011] A support region configured to be connected to the connection portion of the elastic portion;

[0012] A stabilization region, adjacent to and connected to the support region, having a wall thickness thicker than at least a part of the wall thickness of the support region.

[0013] In one embodiment, the support region has at least two wall thicknesses, and a part closer to the connection portion has a thicker wall thickness to achieve a support function.

[0014] In one embodiment, the adjustment region surrounds the patient's nasal airway and oral airway during use.

[0015] In one embodiment, the stabilization region is the region with the least proportion in the elastic portion main body of the patient interface pad.

[0016] In one embodiment, the regions of the elastic portion main body are smoothly connected without obvious dividing lines.

[0017] The present invention also discloses a patient interface pad applied to the CPAP field according to an embodiment of the present application, for delivering breathable pressurized gas to a patient to treat sleep apnea. The patient interface pad includes:

[0018] A rigid portion, having an air inlet opening for receiving breathable pressurized gas and being arranged to be connected to the elastic portion at one end;

[0019] An elastic portion, having a single-layer wall and integrally formed with the rigid portion, including an elastic portion main body that at least partially contacts the patient's face during use and forms a seal, and a connection portion that forms a connection with the rigid portion;

[0020] Wherein the elastic portion main body includes:

[0021] An adjustment region, having an opening close to the patient's face and an edge portion adjacent to the opening;

[0022] A support region configured to be connected to the connection portion of the elastic portion, and its wall thickness is 2 - 9 times that of the adjustment region;

[0023] A stabilization region, adjacent to and connected to the support region, and its wall thickness is 3 - 10 times that of the adjustment region.

[0024] In one embodiment, the wall thickness of the adjustment region is at least 0.55 mm.

[0025] In one embodiment, the width of the edge portion of the adjustment region is at most 2 cm.

[0026] In one embodiment, each region of the elastic portion body has a uniform wall thickness.

[0027] In one embodiment, the wall thickness changes between regions of the elastic portion body are achieved in a step - change manner, and there are distinct dividing lines between the regions.

[0028] The present invention also discloses a patient interface pad provided by an embodiment of the present application, which is applied to the CPAP field and is used to deliver breathable pressurized gas to a patient to treat sleep apnea. The patient interface pad includes:

[0029] A rigid portion having an air inlet opening for receiving breathable pressurized gas and being arranged to be connected to an elastic portion at one end;

[0030] An elastic portion integrally formed with the rigid portion, including an elastic portion body that at least partially contacts the patient's face during use and forms a seal, and a connecting portion that forms a connection with the rigid portion;

[0031] Wherein the elastic portion body has at least three different wall thicknesses and at least two surface treatment methods, at least including:

[0032] An adjustment region having an opening close to the patient's face and an edge portion adjacent to the opening, wherein at least a part of the surface treatment method of the edge portion is polishing treatment;

[0033] A support region configured to be connected to the connecting portion of the elastic portion, having a wall thickness thicker than that of the adjustment region at the top adjacent to the adjustment region, for preventing the patient's nose from touching the bottom during use;

[0034] A stable region adjacent to and connected to the support region, having a wall thickness thicker than that of the adjustment region.

[0035] In one embodiment, the support region has a gradually changing wall thickness at the top adjacent to the adjustment region, with a thicker wall thickness closer to the connecting portion.

[0036] In one embodiment, the maximum width of the adjustment region at the top of the patient interface pad for accommodating the nose does not exceed 5.5 cm.

[0037] In one embodiment, the portion of the adjustment region in contact with the patient's nose during use has an inward depression, configured to better accommodate the patient's nose and form a seal.

[0038] In one embodiment, the stable region is the region with the least proportion in the elastic part body of the patient interface pad.

[0039] The present invention also discloses a patient interface pad applied to the CPAP field according to the embodiments of the present application, which is used to deliver breathable pressurized gas to a patient to treat sleep apnea. The patient interface pad includes:

[0040] A rigid part, having an air inlet opening for receiving breathable pressurized gas and being arranged to be connected to the elastic part at one end;

[0041] An elastic part, integrally formed with the rigid part, including an elastic part body that at least partially contacts the patient's face during use and forms a seal, and a connecting part that forms a connection with the rigid part;

[0042] Wherein the elastic part body has at least three different wall thicknesses, including:

[0043] An adjustment region, having an opening close to the patient's face and an edge part adjacent to the opening;

[0044] A support region, configured to be connected to the connecting part of the elastic part and having a gradually changing wall thickness in a part close to the connecting part;

[0045] A stable region, adjacent to and connected to the support region.

[0046] In one embodiment, the adjustment region has a nasal adjustment part with a wall thickness between that of the edge part and the support region near the edge part.

[0047] In one embodiment, the width of the edge part of the adjustment region is at most 2 cm.

[0048] In one embodiment, the stable region is the region with the least proportion in the elastic part body of the patient interface pad.

[0049] In one embodiment, the wall thickness changes between different regions of the elastic part body are achieved in a stepwise manner, and there are obvious demarcation lines between the regions.

[0050] The present invention also discloses a patient interface pad applied to the CPAP field according to the embodiments of the present application, which is used to deliver breathable pressurized gas to a patient to treat sleep apnea. The patient interface pad includes:

[0051] A rigid part, having an air inlet opening for receiving breathable pressurized gas and being arranged to be connected to the elastic part at one end;

[0052] The elastic part, having a single-layer wall and integrally formed with the rigid part, includes an elastic part body that at least partially contacts the patient's face during use and forms a seal, and a connecting part that connects to the rigid part;

[0053] Wherein the elastic part body includes:

[0054] An adjustment area, having an opening close to the patient's face and an edge part adjacent to the opening, and a nasal side adjustment part close to the edge part and with a wall thickness between that of the edge part and the support area, and at least part of the wall thickness of the adjustment area is at least 0.3 mm;

[0055] A support area, configured to be connected to the connecting part of the elastic part;

[0056] A stable area, adjacent to and connected to the support area.

[0057] In one embodiment, the stable area has a wall thickness that is thicker than at least part of the adjustment area and the support area.

[0058] In one embodiment, the support area has at least two wall thicknesses, and a part close to the connecting part has a gradually changing wall thickness to achieve a supporting effect.

[0059] In one embodiment, the elastic part has at least three different wall thicknesses.

[0060] In one embodiment, the wall thickness changes between different areas of the elastic part body in a uniformly varying manner, and there is no obvious demarcation line between the areas.

[0061] The patient interface pad implementing the present invention has at least the following beneficial effects:

[0062] 1) By testing the pressure values and sensitivities of different regions of the face and combining with the sealing performance of the patient interface pad, different regions are divided on the main body of the elastic part. At the same time, each region also has certain functions, providing higher comfort and better user experience for the patient and improving the patient's compliance with the treatment. Through platforms such as the CPAP forum, reddit, the customer review area of Amazon, and YouTube, the present invention learns that most of the existing patient interface pads in the market have problems such as discomfort or air leakage during the wearing process. The reasons for the discomfort caused to the patient during the wearing process are not only related to the material of the patient interface pad itself, but also that the patient interface pad cannot fully fit the patient's face. Since the regions of the human face have different curved outer contours, the existing patient interface pads in the market cannot be adjusted and changed according to the curved outer contours of the regions of the face. Therefore, they cannot provide satisfactory comfort and pressure magnitude to the patient, which is also the reason for the insufficient sealing performance of the existing patient interface pads in the market. When the same magnitude of pressure acts on the elastic part of the patient interface pad, the elastic part undergoes the same degree of deformation under the pressure to fit the face. However, due to the different outer contour curves of the face, the same degree of deformation of the elastic part cannot achieve complete fitting with the patient's face, resulting in air leakage. In response to this discovery, the present invention has conducted relevant experiments on the patient interface pad and the human face as follows: ① Prepare the required equipment and materials, including: a human head model with standard dimensions, patient interface pads of different types and sizes, pressure sensors (which can be silicon-based pressure sensors or flexible pressure sensors), a pressure device, a computer or a data acquisition and analysis system. ② Attach the pressure sensors as densely as possible to the regions of the face of the head model (or wear them on the face of the head model), fix patient interface pads of different types or sizes to the face of the head model, apply the same pressure to the patient interface pads with a standard pressure device (pressure clamp or other equipment) and record the data of the pressure sensors in each region of the face, and conduct repeated tests and data recording. ③ Analyze and calculate the average value of the pressure magnitudes in each region of the face of the head model to adjust the size and wall thickness of the patient interface pad in each region of the face, and solve the problems of poor sealing caused by different degrees of fitting of the patient interface pad in each region of the face and poor comfort caused by uneven pressure distribution. Through data analysis and conclusion, the wall thickness of the region of the main body of the elastic part of the patient interface pad corresponding to the region with the largest average pressure in the face of the head model is reduced, so that the patient's facial region can fit the corresponding position of the patient interface pad more comfortably. At the same time, the wall thickness of the region of the main body of the elastic part of the patient interface pad corresponding to the region with a smaller average pressure in the face of the head model is designed to be an appropriate thickness, providing a better user experience for the patient while strengthening the patient interface pad to prevent air leakage. During the experiment, it was also found that some parts of the existing patient interface pads in the market are relatively easy to be blown over. Therefore, this region is thickened to form a thicker region to prevent turning out and air leakage.In summary, the present invention draws conclusions based on accurate experimental data, and designs the main body of the elastic part with the maximum contact with the patient's face of the patient interface pad to be divided into at least three regions, namely an adjustment region, a stabilization region, and a support region. The adjustment region is configured to increase the compatibility with the patient's face and nose, the stabilization region is a thickened region to prevent the elastic part from turning outwards, and the support region is used to support the patient interface pad. In order to ensure the support function of the elastic part of the patient interface pad, the present invention sets at least two different thicknesses for the support region. The wall thickness of the partial support region close to the connection part is relatively thick, and the wall thickness of this region can be variable. When in use, the wall thickness of the partial support region close to the patient's face is relatively thin.

[0063] 2) A thinner edge part is set in the adjustment area to increase the compatibility with the patient's face, making the elastic part of the patient interface pad fit the patient's face more closely and improving the sealing performance. According to the above experiments, the present invention notices that the main body of the elastic part of the patient interface pad on the market has a great impact on the overall sealing performance and comfort of the entire patient interface pad near the edge part facing the opening towards the patient's face. Therefore, the present invention redesigned this part to make the patient interface pad more suitable for most patients while improving the use comfort and sealing performance. a) In the messages of some Amazon buyers and the customer reviews on other platforms, the present invention finds that although the patient interface pads on the market are provided with different size types of S / M / L, due to the differences in race and weight, there are still some patients who cannot find a patient interface pad that fits their face size. There are uncomfortable situations where using the L size will cause air leakage and using the M size will cause obvious squeezing. Therefore, the present invention makes the main body of the elastic part of the patient interface pad thinner near the edge part facing the opening towards the patient's face to be compatible with more face shapes. Due to the characteristic that the thinner edge part is convenient to turn inwards, patients with smaller faces can directly use the inner edge as the fitting and sealing edge under the action of pressurized gas, while patients with larger faces can press down the edge part of the patient interface pad and actually use the edge of the supporting part near the edge part for fitting and sealing. The present invention changes the face size type suitable for the patient interface pad from a certain value to a certain range, which is convenient for patients who cannot find the right size within each brand to choose, and expands the compatibility of the patient interface pad. b) In addition to the advantage of increasing compatibility, the present invention designs the edge part to be thinner, which also has the advantage of better sealing performance of the patient interface pad. The edge part is designed as a thin area with a uniform thickness, so that the edge part is better blown up by the airflow during use, is more likely to contact the patient's face to form a seal, making the seal more stable. And the thinner edge part has greater flexibility and can better adapt to different outer contours of the face. The uniform thickness means that the contact surface of the inner edge of the patient interface pad exerts a more average force on the patient's face, without excessive pressure points or discomfort, thus providing more uniform comfort. At the same time, the uniform thickness can also be applicable to more face outer contour shapes and fit more people. c) The present invention uses a special surface treatment process and performs polishing treatment on the edge part. The polished surface is smoother than other surfaces and has greater adhesion to the skin during use, so as to fit more stably. And the polished surface is more uniform, without concave or protruding surfaces, which helps to increase the sealing performance between the elastic part of the patient interface pad and the patient's face and reduce air leakage. However, to ensure the comfort of the patient interface pad, the patient interface pad is also provided with a relatively rough frosted surface, and the relatively rough surface has less adhesion to the skin during use, which improves the comfort of the patient when wearing the patient interface pad.The present invention uses a method combining two surface treatment methods, which can not only ensure better sealing performance but also enable the patient interface pad to maintain its original comfort.

[0064] 3) Design an area near the nasal airway that is easy to adjust to improve the accommodation of the patient's nose and prevent bottoming out. One of the biggest differences in the faces of different people lies in the height and width of the nose. Some people have a higher nasal bridge while some have a lower one, and some people have a narrower nose while some have a wider one. This difference results in a variety of noses with different heights and widths being adapted to the patient interface pad. The design of the area where the elastic part body fits the patient's nasal wings directly affects the fitting and sealing effect between the patient interface pad and the patient's face, which is an extremely important link. The patient interface pad shown in the present invention has at least two different wall thicknesses in the area where the elastic part body fits the patient's nasal wings and the side of the nose, so as to provide a greater accommodation for the nose during use, be able to adapt to various nose heights and widths, and further increase the compatibility of the patient interface pad with the patient's face, thereby providing the best treatment effect. Specifically, a) When the patient uses the patient interface pad shown in the present invention, the area with the largest contact with the patient's nose on the elastic part body is the adjustment area with a thinner wall thickness. Because of its thinner wall thickness, it can more easily fit the patient's nose. When the adjustment area is subjected to the pressure from the patient's nose, it can also more easily obtain the corresponding deformation size according to the height of the nose, and the greater softness brought by its thinner wall thickness results in less pressure on the patient's nose and improved use comfort. b) The support area has a thicker wall thickness than the adjustment area at the top adjacent to the adjustment area, and is set to prevent the elastic part from directly bottoming out due to excessive pressure from the patient's nose during use, provide greater support for the patient's nose, and reduce the discomfort caused by the patient interface pad. c) The adjustment area also has a nasal side adjustment part near the patient's nose. To solve the problem that the patient interface pad is not suitable for some patients with different nose widths, the compatibility of the patient interface pad with the patient's nose is improved. When a patient with a narrower nose uses it, under the action of pressurized gas, the boundary of the thinner area is directly used as the outer contour of the elastic part of the patient interface pad that changes to accommodate the nose. When a patient with a wider nose uses it, the nasal side adjustment part can be pressed down, and part of the nasal side adjustment part or directly the boundary of the nasal side adjustment part is used as the outer contour of the elastic part of the patient interface pad that changes to accommodate the nose, thereby adapting to the faces of patients with different nose widths to ensure the best fit between the patient interface pad and the patient's face and help meet the needs of different patients.

[0065] 4) Comparing the patient interface pads with laces and double layers, on the basis of maintaining the original functions, the present invention has a simple mold, a reduced defective rate, which reduces the production cost while being environmentally friendly and easy to clean. Most of the existing market patient interface pads are designed as double-layer structures or with laces to ensure that the elastic part does not turn outwards. Although these two methods solve the problem of the elastic part turning outwards, they also bring many new problems. For example, the design of the double-layer patient interface pad makes it heavier than the single-layer patient interface pad, which is likely to cause discomfort to the patient, especially when the patient is in a long-term wearing state. Both the double-layer patient interface pad and the patient interface pad with laces are more expensive in terms of material cost, require more complex molds, resulting in an increase in mold cost, and the processes used are also more complex. Moreover, due to the complexity of the processes of the double-layer patient interface pad and the patient interface pad with laces, the probability of defective products increases during the manufacturing process, and the increase in the defective rate further increases the manufacturing cost. It may also waste a certain amount of labor cost due to quality control and screening. The patient interface pad shown in the present invention uses the stable area of the elastic part main body to replace the structures of the double-layer patient interface pad or the patient interface pad with laces, so that it has the same functions, simpler processes, lower costs, and higher yield rates. It shows more advantageous features than the existing patient interface pads in all aspects, and meets the requirements of green design, having beneficial effects on climate change and environmental protection. In terms of cleaning, since the double-layer patient interface pad or the patient interface pad with laces is composed of multiple layers of materials, there may be corners where dirt is likely to accumulate and is not easy to clean during cleaning. Over time, it is easy to cause the growth of bacteria and other microorganisms, which has an adverse impact on the health of the patient. The cleaning process will take more time and may require more frequent cleaning times to clean it thoroughly. In addition, during the process of using a ventilator to treat obstructive sleep apnea, the patient interface pad itself is prone to moisture accumulation, and the barrier of the multi-layer materials makes it not easy to volatilize, requiring a longer drying time, which is not conducive to the patient's multiple and long-term use. This is also a factor that is not conducive to the health of the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0066] Figure 1 is a three-dimensional schematic diagram of a patient interface pad in Embodiment 1 of the present invention;

[0067] Figure 2 is a front view of the display diagram of each area of a patient interface pad in Embodiment 1 of the present invention;

[0068] Figure 3 is a side view of the display diagram of each area of a patient interface pad in Embodiment 1 of the present invention;

[0069] Figure 4 is a schematic diagram of the section line of a patient interface pad in Embodiment 1 of the present invention;

[0070] Figure 5 is Figure 4 the schematic diagram of the A-A sectional structure in

[0071] Figure 6 is Figure 4 the schematic diagram of the B-B sectional structure in

[0072] Figure 7 is Figure 4 the schematic diagram of the C-C sectional structure in

[0073] Figure 8 the experimental schematic diagram of a patient interface pad in the first embodiment of the present invention;

[0074] Figure 9 the experimental force display diagram of a patient interface pad in the first embodiment of the present invention;

[0075] Figure 10 the display diagram of the change of the edge part when patients with different face sizes use the patient interface pad in the first embodiment of the present invention;

[0076] Figure 11 the schematic diagram of the edge part of the patient interface pad in the first embodiment of the present invention using polishing treatment;

[0077] Figure 12 the display diagram of the change of the adjustment area when patients with different nose heights and widths use the patient interface pad in the first embodiment of the present invention;

[0078] Figure 13 the schematic diagram of the patient interface pad in the first embodiment of the present invention to prevent the nose from touching the bottom;

[0079] Figure 14 the schematic diagram of another implementation manner of the patient interface pad in the first embodiment of the present invention with different area divisions;

[0080] Figure 15 the schematic diagram of the way that the elastic part and the rigid part of the patient interface pad in another implementation manner in the first embodiment of the present invention are separated and connected by a physical clip;

[0081] Figure 16 the schematic diagram of the patient interface pad in another implementation manner in the first embodiment of the present invention with an exhaust port or a noise reduction component;

[0082] Figure 17 the schematic diagram of the patient interface pad in another implementation manner in the first embodiment of the present invention with a comfort layer;

[0083] Figure 18 the schematic diagram of the elastic part shown in the present invention being used on another form of patient interface pad in the second embodiment of the present invention;

[0084] Figure 19 Schematic diagram of the elastic part shown in the present invention for another implementation mode in the second embodiment of the present invention being used on other forms of patient interface pads;

[0085] Figure 20 Schematic diagram showing different forms of the stable area of the patient interface pad in the third embodiment of the present invention;

[0086] Figure 21 Schematic diagram showing different forms of the adjustment area of the patient interface pad for another implementation mode in the third embodiment of the present invention;

[0087] Figure 22 Schematic diagram showing different forms of the support area of the patient interface pad for another implementation mode in the third embodiment of the present invention. Detailed implementation mode

[0088] For the convenience of understanding the invention, the invention will be described more comprehensively below with reference to the relevant drawings. The typical embodiments of the invention are given in the drawings. However, the invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, these embodiments are provided to make the disclosure of the invention more thorough and comprehensive.

[0089] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which the invention belongs. The terms used in the description of the invention herein are only for the purpose of describing specific embodiments and are not intended to limit the invention.

[0090] In view of the situation that the existing patient interface pads for delivering gas to the patient's airway on the market have insufficient sealing performance and comfort, high production difficulty and high cost, etc., the present invention provides a patient interface pad with a simpler structure and better comfortable wearing experience for patients. The patient interface pad designed by the present invention not only optimizes the existing design, but also provides several different structures of patient interface pads for patients to choose according to their respective needs and preferences. It is a better technical invention for users, producers and the market. The reduction of material waste by the present invention is also a sustainable and environmentally friendly design for the environment.

[0091] The following describes several structures of the patient interface pad of the present invention with specific examples.

[0092] Embodiment 1

[0093] This embodiment provides a patient interface pad 1 applied to the CPAP field. This embodiment provides a three-dimensional schematic diagram, display diagrams of each area, a cross-sectional structure schematic diagram, experimental display and force diagrams, and a display diagram of the use effect of the patient interface pad 1, with reference to Figure 1-13。The patient interface pad 1 shown in the embodiment includes a rigid part 2 and an elastic part 3. The elastic part 3 has a connecting part 311 connected to the rigid part 2 and an elastic part body 31. The elastic part body 31 at least includes an adjustment area 312, a support area 313, and a stabilization area 314. Each area has different corresponding functions and is configured to improve the wearing comfort of the patient, enhance the sealing performance of the patient interface pad 1, and its compatibility with the patient's face.

[0094] The patient interface pad 1 includes a rigid part 2, which has an air inlet opening 21 for receiving breathable pressurized gas and is arranged to be connected to the elastic part 3 at one end. The air inlet opening 21 can be an opening formed by a wall extending in the direction towards or away from the patient's face. When in use, it is configured to be connected to a catheter, a frame, or an elbow for delivering breathable pressurized gas by means of snap-fastening, clamping, magnetic attraction, etc. The rigid part 2 provides the required structural stability for the patient interface pad 1, ensuring that the shape of the patient interface pad 1 can remain unchanged during wearing, thereby maintaining the main function of the patient interface pad 1. Its material can be high-density polyethylene (HDPE), polypropylene (PP), polycarbonate (PC), polystyrene (PS), etc.

[0095] The elastic part 3, integrally formed with the rigid part 2, includes an elastic part main body 31 that at least partially contacts the patient's face during use and forms a seal, and a connecting part 311 that connects with the rigid part 2. The elastic part 3 is composed of a material softer than the rigid part 2, such as silicone, rubber, elastic plastic, etc., and is configured such that the connecting part 311 is connected to the rigid part 2 by means of a flexible clip, glue, magnetic attraction, co-molding, etc. during use. At least part of the elastic part main body 31 contacts the patient's face during use to disperse the pressure of the patient interface pad 1 on the patient's face. By improving the design of the elastic part main body 31, its performance is enhanced, the comfort, compatibility, and sealing performance of the patient interface pad 1 are improved, ensuring that the patient obtains a better experience during treatment, reducing discomfort, thereby improving the treatment compliance and enhancing the treatment effect. The elastic part main body 31 is designed as a single-layer wall, achieving the same effect as a double-layer wall, while facilitating the patient to clean the patient interface pad 1 and reducing the weight of the patient interface pad 1, avoiding discomfort for the patient during long-term wearing, saving material and mold costs, simplifying the process, and reducing the defect rate. It also has the advantages of being easy to dry and clean and not easily breeding bacteria in terms of cleaning. Through experimental tests on different types and sizes of patient interface pads 1 (by placing pressure sensors on the face of a human head model with standard dimensions, applying the same pressure to the patient interface pad 1 and recording the data of the pressure sensors in each area of the face, conducting repeated tests and data analysis, and obtaining the average value of the pressure in each area of the face of the head model), the conclusion is drawn that at least three different wall thicknesses are required for the elastic area. Each area of the elastic part main body 31 has a uniform wall thickness, or it can have a non-uniform wall thickness such as a gradually changing wall thickness. The elastic area main body of the patient interface pad 1 is divided into at least three areas, and the wall thickness changes in a uniformly varying manner between the areas of the elastic part 3 to achieve different wall thicknesses, with no obvious boundary line between the areas (no steps, and the change in wall thickness between the areas cannot be seen with the naked eye). It can also be that the wall thickness changes in a sudden manner between the areas of the elastic part 3, with an obvious boundary line between the areas. The elastic part main body 31 can also have at least two surface treatment methods.

[0096] The elastic part body 31 has at least three different wall thicknesses, including at least an adjustment area 312, which has an opening close to the patient's face and an edge part 3121 adjacent to the opening. During use, it surrounds the patient's nasal airway and oral airway and is configured to be adjustable according to the sizes of different patients' faces, as well as the height and width of the nose. The maximum width of the adjustment area at the top of the patient interface pad for accommodating the nose does not exceed 5.5 cm (including the edge part at the top and the nasal side adjustment part). The part that is adjustable according to the sizes of different patients' faces is the edge part 3121, and the edge part 3121 has a relatively thin thickness, so the edge part 3121 can be more easily turned inwards to adapt to faces of different sizes. Specifically, during use, for patients with smaller faces, the edge part 3121 can be blown up under the action of pressurized gas, and the inner edge is directly used as the edge for fitting and sealing; while for patients with larger faces, the edge part 3121 of the patient interface pad 1 can be pressed down, and the edge of the support part close to the edge part 3121 is actually used for fitting and sealing. At least part of the wall thickness of the edge part 3121 adjacent to the opening does not exceed 0.6 mm, and at least part of the wall thickness of the adjustment area 312 is at least 0.3 mm. Designing the edge part 3121 as a thinner area is also to achieve better sealing, so that the edge part 3121 can be more easily blown up by the airflow during use, making the sealing formed by the contact between the edge part 3121 and the patient's face better and more stable. Considering both sealing and comfort, the width of the edge part 3121 of the adjustment area 312 is optimally set to at most 2 cm. In addition, the edge part 3121 also has a uniform thickness, making the patient interface pad 1 more comfortable. The uniform inner edge makes the contact surface between the patient interface pad 1 and the patient's face more even, without too many pressure points, thus providing better comfort. The edge part 3121 also has a special surface treatment. Specifically, at least part of the surface treatment method of the edge part 3121 is polishing treatment. The polished surface is smoother than other surfaces and has greater adhesion to the skin during use, so as to fit more stably. However, to ensure the comfort of the patient interface pad 1, the patient interface pad 1 is also provided with a relatively rough frosted surface. The present invention uses a method of combining two surface treatment methods, which can not only ensure better sealing but also keep the original comfort of the patient interface pad 1.The part that is adjusted according to the height and width of the patient's nose is the adjustment area 312 located at the top of the patient interface pad 1 and including the nasal side adjustment part 3122. The adjustment area 312 has at least two thicknesses to provide a greater accommodation degree for the nose during use. Specifically, the adjustment area 312 has a nasal side adjustment part 3122 near the edge part 3121 and with a wall thickness between the edge part 3121 and the support area 313. In the adjustment area 312 at the top of the patient interface pad 1, the nasal side adjustment part 3122 has a thicker wall thickness, and the rest has a thinner wall thickness. During use, patients with a narrower nose directly blow up the edge part 3121 and the nasal side adjustment part 3122 under the action of pressurized gas, and use the boundary with the thinner wall thickness as the edge where the elastic part 3 of the patient interface pad 1 seals the nose; while patients with a wider nose can press down the nasal side adjustment part 3122 and use part of the nasal side adjustment part 3122 or directly the boundary of the nasal side adjustment part 3122 as the edge where the elastic part 3 of the patient interface pad 1 seals the nose, thereby adapting to the faces of patients with different nose widths. This method ensures the best fit between the patient interface pad 1 and the patient's face and helps to meet the needs of different patients. The nasal side adjustment part 3122 can have a uniform wall thickness or a gradually changing wall thickness. In addition, the part of the adjustment area 312 that contacts the patient's nose during use has an inward depression (such as. Figure 12 as shown) and is configured to better accommodate the patient's nose and form a seal.

[0097] The support area 313 is configured to be connected to the connecting part 311 of the elastic part 3. The support area 313 is the area with the largest area among the areas, and at least partially contacts the patient's face during use, providing a relatively large supporting force for the face. Through experimental tests, it is demonstrated that the most suitable thickness of the support area 313 is between the stable area 314 and the adjustment area 312. Its wall thickness is 2-9 times that of the adjustment area 312, and at least a part of the wall thickness of the support area 313 can be 1.4 mm. However, this wall thickness still cannot reach the minimum wall thickness for supporting the face. Therefore, the support area 313 is set to have at least two wall thicknesses, and a thicker wall thickness is provided in a part close to the connecting part 311 to achieve the supporting effect. Specifically, it is divided into a part close to the face and a part away from the face. The part close to the face is completely or partially in contact with the patient's face during use and is the thinner part; while the part away from the face can be partially in contact with the patient's face during use, and it has a gradually changing thickness and is the thicker part (thicker relative to the part close to the face). The boundary connecting the two parts can be continuous (smooth connection) or discontinuous (with steps). At the top adjacent to the adjustment area 312, there is a wall thickness thicker than that of the adjustment area 312, which is used to prevent the patient's nose from touching the bottom during use. Specifically, the support area 313 has a gradually changing wall thickness at the top adjacent to the adjustment area 312, where the wall thickness close to the connecting part 311 is thicker, and is configured to prevent the patient's nose from touching the bottom during use. The wall thickness of the support area 313 at the top adjacent to the adjustment area 312 can also be uniform.

[0098] The stable area 314 is adjacent to and connected to the support area 313. The stable area 314 has a wall thickness thicker than at least a part of the adjustment area 312 and the support area 313, and is configured to be located at the upper end of the patient interface pad 1, close to the nasal side adjustment part 3122, and is used to prevent the area from folding under the action of pressurized gas during use. The stable area 314 is the area with the smallest proportion in the elastic part main body 31 of the patient interface pad 1. Its wall thickness is 3-10 times that of the adjustment area 312. The shape of the stable area 314 can be strip-shaped, triangular or other shapes.

[0099] In another embodiment, in addition to the area division shown in the present invention, the patient interface pad 1 may also have other different area divisions, (such as Figure 14 shown, Figure A shows no nasal side adjustment part 312, and Figure B shows different areas of each area).

[0100] In another embodiment, the elastic part 3 of the patient interface pad 1 and the rigid part 2 are detachably connected, and the connection method between the elastic part 3 and the rigid part 2 can be connected by a physical clip (such as Figure 15 shown), adhesive connection, magnetic connection or other connection methods.

[0101] In another embodiment, the patient interface pad 1 has an exhaust port 4 provided on the rigid portion 2, and the patient interface pad may further have a noise reduction component 41 (as Figure 16 shown, Figure 16 A shows that the patient interface pad 1 is provided with an exhaust port 4, Figure 17 B shows that the patient interface pad 1 is provided with a noise reduction component 41), and the noise reduction component 41 may be composed of noise reduction cotton or noise reduction net and other materials that can provide noise reduction.

[0102] In another embodiment, the patient interface pad 1 may be provided with a comfort layer on the elastic portion 3 to make the patient's use more comfortable. The material of the comfort layer may be foam material, textile material, or a composite material of both (as shown in 17, Figure 17 only one of the comfort materials is shown to be provided on the elastic portion 3, Figure 17 A shows that the foam material is provided in contact with the elastic portion 3 of the patient interface pad 1, Figure 17 B shows that the textile material is provided in contact with the elastic portion 3 of the patient interface pad 1), and the comfort layer and the patient interface pad 1 can be connected by means of a film, an adhesive, or physical connection.

[0103] Embodiment 2

[0104] This embodiment provides a patient interface pad 1 applied to the CPAP field, as shown in Figure 18 、 Figure 19 . This embodiment provides a three-dimensional schematic diagram of the patient interface pad 1. In Figure 18 、 Figure 19 the embodiments of the present invention shown, the difference from the patient interface pad 1 in Embodiment 1 is that: in another form, the elastic portion 3 shown in the present invention is provided on the patient interface pad 1. The elastic portion 3 of the patient interface pad 1 shown in the present invention is obtained through experimental tests and comprehensive considerations in various aspects, which is a patient interface pad 1 that is not only comfortable to wear but also has a more stable sealing performance. It can be used not only for full-face masks but also for other patient interfaces, such as nasal masks and oro-nasal masks, to improve the discomfort and poor sealing performance of other patient interface pads, and ensure the consistency in materials and comfort. Different forms of the patient interface pad 1 use the same type of area division and surface treatment methods, and the same materials can be used to achieve similar functions, reducing the trial-and-error cost, warehousing cost, and management cost of materials; since the area division is generally the same, different forms of the patient interface pad 1 can be obtained only by changing the composition ratio of different regions of the patient interface pad 1, improving the R & D and production efficiency. And compared with double-layer and patient interface pads with laces, the production cost is lower.

[0105] Embodiment 3

[0106] This embodiment provides a patient interface pad 1 applied to the CPAP field. Refer to Figure 20 . This embodiment provides a three-dimensional schematic diagram of the patient interface pad 1. In Figure 20 the embodiment of the present invention shown, the difference from the patient interface pad 1 in the first embodiment is that the stable area 314 of the patient interface pad 1 has a different form. The stable area 314 is discontinuous and consists of several small areas. The advantages of the patient interface pad 1 manufactured by the same method (dividing at least three different areas) are as follows: on the premise of ensuring the consistency of the product in terms of quality, performance, etc., different patient interface pads with different effects or more diverse ones can be provided for different patients to meet the different needs of patients. Since the structures of the patient interface pads are similar, patients can expect the usage effects of the patient interface pads with the same area division, which increases the patients' trust in the product. This method not only increases the diversity of the patient interface pad 1 without making production more complex, but also makes the product more competitive in the existing market with diverse forms, which has potential benefits for both producers and consumers.

[0107] In another embodiment, the adjustment area 312 of the patient interface pad 1 has a different form (as Figure 21 shown), and the adjustment area 312 is discontinuous. The adjustment area 312 is set at the parts with large facial undulations or more sensitive to pressure.

[0108] In another embodiment, the support area 313 of the patient interface pad 1 has a different form. The areas or thicknesses of the thicker part (the part away from the face) and the thinner part (the part close to the face) of the support area 313 are the same as those in the first embodiment, but the change in the wall thickness of the thicker part and the thinner part is limited. For example, it can consist of a uniform thinner part close to the face and a uniform thicker part away from the face (as Figure 22 shown in A); it can also be composed of a uniform thinner part close to the face and a non-uniform part away from the face (as Figure 22 shown in B). Or as Figure 22 shown in C, the areas or thicknesses of the thicker part and the thinner part of the support area 313 are different from those in the first embodiment.

[0109] The technical features of the above-mentioned embodiments can be combined arbitrarily. For the sake of concise description, not all possible combinations of the technical features in the above-mentioned 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.

[0110] Implementing the patient interface pad 1 of the present invention has at least the following beneficial effects:

[0111] 1) By testing the pressure values and sensitivities of different regions of the face, combined with the sealing performance of the patient interface pad 1, different regions are divided for the elastic part main body 31. At the same time, each region also has certain functions, providing higher comfort and better user experience for the patient and improving the patient's compliance with the treatment. Through platforms such as the CPAP forum, reddit, the customer review area of Amazon, and YouTube, the present invention understands that the vast majority of patient interface pads 1 in the existing market have problems of discomfort or air leakage during patient wearing. The reasons for the discomfort caused during wearing are not only related to the material of the patient interface pad 1 itself, but also because the patient interface pad 1 cannot fully fit the patient's face. Since the various regions of the human face have different curved outer contours, the patient interface pads 1 in the existing market cannot be adjusted and changed according to the curved outer contours of the various regions of the face. Therefore, they cannot provide satisfactory comfort and pressure magnitude to the patient, which is also the reason for the insufficient sealing performance of the patient interface pads 1 in the existing market. When the same magnitude of pressure acts on the elastic part 3 of the patient interface pad 1, the elastic part 3 undergoes the same degree of deformation under the pressure to fit the face. However, due to the different curved outer contours of the face, the same degree of deformation of the elastic part 3 cannot achieve full fit with the patient's face, resulting in air leakage. In response to this discovery, relevant experiments were conducted on the patient interface pad 1 and the human face as follows: ① Prepare the required equipment and materials, including: a human head model with standard dimensions, patient interface pads 1 of different types and sizes, pressure sensors (which can be silicon-based pressure sensors or flexible pressure sensors), a pressure device, a computer or a data acquisition and analysis system. ② Attach the pressure sensors as densely as possible to the various regions of the face of the head model (or wear them on the face of the head model), fix the patient interface pads 1 of different types or sizes to the face of the head model, apply the same pressure to the patient interface pad 1 with a standard pressure device (pressure clamp or other equipment) and record the data of the pressure sensors in the various regions of the face, and conduct repeated tests and data analysis. ③ Obtain the mean value of the pressure magnitudes in the various regions of the face of the head model to address the problems of poor sealing caused by different degrees of fit of the patient interface pad 1 in the various regions of the face and poor comfort caused by uneven pressure distribution. Through data analysis and drawing conclusions, the wall thickness of the region in the elastic part main body 31 of the patient interface pad 1 corresponding to the region with the largest mean pressure on the face of the head model is reduced, so that the patient's facial region can fit the corresponding position of the patient interface pad 1 more comfortably. At the same time, the wall thickness of the region of the elastic part main body 31 of the patient interface pad 1 corresponding to the region with a smaller mean pressure on the face of the head model is designed to be an appropriate thickness, providing a better user experience for the patient while strengthening the patient interface pad 1 to prevent air leakage. During the experiment, it was also found that some parts of the existing patient interface pads 1 in the market are relatively easy to be blown over. Therefore, this region is thickened to form a thicker region to prevent turning out and air leakage.In summary, the present invention draws conclusions based on accurate experimental data, and designs to divide the elastic part body 31 with the largest contact with the patient's face of the patient interface pad 1 into at least three regions, namely an adjustment region 312, a stabilization region 314, and a support region 313. The adjustment region is configured to be a part that increases the compatibility with the patient's face and nose. The stabilization region 314 is a region thickened to prevent the elastic part 3 from turning outwards. The support region is the remaining region for supporting the patient interface pad 1 and the patient's face. In order to ensure the support function of the elastic part 3 of the patient interface pad 1, the present invention sets at least two different thicknesses for the support region 313. The wall thickness of the portion close to the connection part 311 of the elastic part 3 is relatively thick, and the wall thickness in this region can be variable. When in use, the wall thickness of the portion close to the patient's face is relatively thin.

[0112] 2) A thinner edge portion 3121 is provided in the adjustment area 312, which increases the compatibility with the patient's face, reduces the patient's sensory characteristics, and makes the elastic portion 3 of the patient interface pad 1 fit more closely to the patient's face, improving the sealing performance. According to the above experiments, the present invention notes that the main body 31 of the elastic portion of the patient interface pad 1 on the existing market has a great impact on the overall sealing performance and comfort of the entire patient interface pad 1 near the edge portion 3121 facing the patient's face. Therefore, the present invention redesigned this part to make the patient interface pad 1 more suitable for most patients while improving the use comfort and sealing performance. a). In the messages of some Amazon buyers and the customer reviews on other platforms, the present invention found that although the patient interface pads 11 on the existing market are provided in sizes of S / M / L, due to differences in ethnicity and weight, there are still some patients who cannot find a patient interface pad 1 that fits their face size. There are uncomfortable situations where using the L size will cause air leakage and using the M size will cause obvious squeezing. Therefore, the present invention makes the main body 31 of the elastic portion of the patient interface pad 1 thinner near the edge portion 3121 facing the patient's face to be compatible with more face shapes. Due to the characteristic that the edge portion 3121 is thinner and convenient to turn inward, patients with smaller faces can directly use the inner edge as the fitting and sealing edge under the action of pressurized gas, while patients with larger faces can press down the edge portion 3121 of the patient interface pad 1 and actually use the edge of the supporting portion near the edge portion 3121 for fitting and sealing. The present invention changes the face size type suitable for the patient interface pad 1 from a certain value to a certain range, which is convenient for patients who cannot find a suitable size within each brand to choose, expanding the compatibility of the patient interface pad 1. b). In addition to the advantage of increasing compatibility, the present invention designs the edge portion 3121 to be thinner, and also has the advantage of making the sealing performance of the patient interface pad 1 better. The edge portion 3121 is designed as a thin area with a uniform thickness, so that the edge portion is better blown up by the air flow during use, easier to contact with the patient's face to form a seal, making the seal more stable. And the thinner edge portion 3121 has greater flexibility and can better adapt to different outer contours of the face. The uniform thickness means that the contact surface of the inner edge of the patient interface pad exerts a more average force on the patient's face, without excessive pressure points or discomfort, thus providing more uniform comfort. At the same time, the uniform thickness can also be applicable to more face outer contour shapes and fit more people. c). The present invention uses a special surface treatment process and performs polishing treatment on the edge portion 3121. The polished surface is smoother than other surfaces and has greater adhesion to the skin during use, so as to fit more stably. This improves the comfort of the patient when wearing the patient interface pad 1 and reduces the possibility of the face being stimulated when contacting the non-smooth elastic portion 3, which is very important for patients with sensitive skin.Moreover, the polished surface is more uniform, without depressions or protruding surfaces, which helps to increase the sealing between the elastic part 3 of the patient interface pad 1 and the patient's face and reduce air leakage. However, to ensure the comfort of the patient interface pad 1, the patient interface pad 1 is also provided with a relatively rough matte surface. The relatively rough surface can better adapt to the skin and reduce the sense of unevenness. The present invention uses a method combining two surface treatment methods, which can not only ensure better sealing but also enable the patient interface pad 1 to maintain its original comfort.

[0113] 3) Design an area near the nasal airway that is easy to adjust, improve the accommodation for the patient's nose, and prevent bottoming out. One of the biggest differences in the faces of different people is reflected in the height and width of the nose. Some people have a higher nasal bridge while some have a lower one, and some people have a narrower nose while some have a wider one. This difference results in a variety of noses with different heights and widths to be adapted to the patient interface pad 1. The design of the area where the elastic part main body 31 fits with the patient's nasal wings directly affects the fitting and sealing effect between the patient interface pad 1 and the patient's face, which is an extremely important link. The patient interface pad 1 shown in the present invention has at least two different wall thicknesses in the area where the elastic part main body 31 fits with the patient's nasal wings and the side of the nose, so as to provide a greater accommodation for the nose during use, be able to adapt to various nose heights and widths, and further increase the compatibility of the patient interface pad 1 with the patient's face, thus providing the best treatment effect. Specifically, a). When the patient uses the patient interface pad 1 shown in the present invention, the area with the largest contact with the patient's nose on the elastic part main body 31 is the adjustment area 312 with a thinner wall thickness. Because of its thinner wall thickness, it can more easily fit the patient's nose. When the adjustment area is subjected to the pressure from the patient's nose, it can also more easily obtain the corresponding deformation size according to the height of the nose, and the greater softness brought by its thinner wall thickness improves the comfort of the patient during use. b). The support area 313 has a thicker wall thickness than the adjustment area at the top adjacent to the adjustment area 312, and is set to prevent the elastic part 3 from directly bottoming out due to excessive pressure from the patient's nose during use, provide greater support for the patient, and reduce the discomfort caused by the patient interface pad 1 to the nose. c). The adjustment area 312 also has a nasal side adjustment part 3122 near the part close to the patient's nose. To solve the problem that the patient interface pad is not suitable for some patients with different nose widths, the compatibility of the patient interface pad 1 with the patient's nose is improved. When a patient with a narrower nose uses it, under the action of pressurized gas, the boundary of the thinner area is directly used as the outer contour of the elastic part 3 of the patient interface pad 1 for accommodating the nose to change. While when a patient with a wider nose uses it, the nasal side adjustment part 3122 can be pressed down, and part of the nasal side adjustment part 3122 or directly the boundary of the nasal side adjustment part 3122 is used as the outer contour of the elastic part 3 of the patient interface pad 1 for accommodating the nose to change, so as to adapt to the faces of patients with different nose widths, ensure the best fit between the patient interface pad 1 and the patient's face, and help to meet the needs of different patients.

[0114] 4) Comparing the patient interface pad 1 with laces and double layers, on the basis of maintaining the original functions, the present invention has a simple mold, reduces the use of materials, has a low defective rate, reduces production costs while protecting the environment, and is easy to clean. Most of the patient interface pads 1 in the existing market are designed as double-layer structures or with laces to ensure that the elastic part 3 does not turn outwards. Although these two methods solve the problem of the elastic part 3 turning outwards, they also bring many new problems. For example, the design of the double-layer patient interface pad 1 makes it heavier than the single-layer patient interface pad, which is likely to cause discomfort to the patient, especially when the patient is in a long-term wearing state. Both the double-layer patient interface pad and the patient interface pad with laces are more expensive in terms of material costs, require more complex molds, resulting in an increase in mold costs, and the processes used are also more complex. Moreover, due to the complexity of the processes of the double-layer patient interface pad and the patient interface pad with laces, the probability of defective products may increase during the manufacturing process, and the increase in the defective rate further increases their manufacturing costs. It may also waste a certain amount of labor costs due to quality control and screening. The patient interface pad shown in the present invention uses the stable area 314 of the elastic part main body 31 to replace the structures of the double-layer patient interface pad or the patient interface pad 1 with laces, so that it has the same functions, uses less materials, has a simpler process, lower costs, and a higher qualified rate, showing more advantageous features than the existing patient interface pads in all aspects. And because the patient interface pad 1 shown in the present invention uses less materials, it meets the requirements of green design and has a beneficial effect on climate change and environmental protection. In terms of cleaning, since the double-layer patient interface pad or the patient interface pad 1 with laces is composed of multiple layers of materials, there may be corners where dirt is likely to accumulate and is not easy to clean during cleaning. Over time, it is likely to cause the growth of bacteria and other microorganisms, which has an adverse impact on the health of the patient. The cleaning process will take more time and may require more frequent cleaning times to reach a relatively clean standard. In addition, during the process of using a ventilator to treat obstructive sleep apnea, the patient interface pad 1 itself is prone to the accumulation of moisture, and the barrier of the multiple layers of materials makes it not easy to volatilize, requiring a longer drying time, which is not conducive to the patient's multiple and long-term use. This is also a factor that is not conducive to the health of the patient.

[0115] The embodiments of the invention have been described above in conjunction with the accompanying drawings. However, the invention is not limited to the above specific embodiments. The above specific embodiments are merely illustrative and not restrictive. Under the inspiration of the invention, those of ordinary skill in the art can also make many forms without departing from the spirit of the invention and the scope protected by the claims. All of these fall within the protection scope of the invention.

Claims

1. A patient interface cushion applied to the CPAP field, which is used to deliver breathable pressurized gas to a patient for treating sleep apnea, characterized in that, The patient interface cushion includes: A rigid part having an air inlet opening for receiving breathable pressurized gas, provided to be connected to an elastic part at one end; An elastic part integrally formed with the rigid part, including an elastic part main body that at least partially contacts the patient's face during use and forms a seal, and a connecting part that forms a connection with the rigid part; Wherein the elastic part main body has at least three different wall thicknesses, at least including: An adjustment area having an opening close to the patient's face and an edge part adjacent to the opening, wherein at least part of the wall thickness of the edge part adjacent to the opening does not exceed 0.6 mm; A support area configured to be connected to the connecting part of the elastic part; A stable area adjacent to and connected to the support area, having a wall thickness thicker than at least part of the wall thickness of the support area.

2. The patient interface pad according to claim 1, wherein The support area has at least two wall thicknesses, and has a thicker wall thickness in a part close to the connecting part to achieve a support effect.

3. The patient interface pad according to claim 1, wherein The adjustment area surrounds the patient's nasal airway and oral airway during use.

4. The patient interface pad according to claim 1, characterized in that, The stable area is the area with the least proportion in the elastic part main body of the patient interface cushion.

5. The patient interface pad according to claim 1, wherein The regions of the elastic part main body are smoothly connected without obvious demarcation lines.

6. A patient interface cushion for use in the CPAP field, which is used to deliver breathable pressurized gas to a patient to treat sleep apnea, characterized in that, The patient interface cushion includes: A rigid part having an air inlet opening for receiving breathable pressurized gas, provided to be connected to an elastic part at one end; An elastic part having a single-layer wall and integrally formed with the rigid part, including an elastic part main body that at least partially contacts the patient's face during use and forms a seal, and a connecting part that forms a connection with the rigid part; Wherein the elastic part main body includes: An adjustment area having an opening close to the patient's face and an edge part adjacent to the opening; A support area configured to be connected to the connecting part of the elastic part, and its wall thickness is 2-9 times that of the adjustment area; A stable area adjacent to and connected to the support area, and its wall thickness is 3-10 times that of the adjustment area.

7. The patient interface pad according to claim 6, wherein The wall thickness of the adjustment area is at least 0.3 mm.

8. The patient interface pad according to claim 6, wherein The width of the edge part of the adjustment area is at most 2 cm.

9. The patient interface pad according to claim 6, wherein Each region of the elastic part main body has a uniform wall thickness.

10. The patient interface pad according to claim 6, wherein The change of different wall thicknesses in each region of the elastic part main body is achieved by a sudden change, and there are obvious demarcation lines between the regions.

11. A patient interface cushion for use in the CPAP field, which is used to deliver breathable pressurized gas to a patient to treat sleep apnea, characterized in that The patient interface cushion includes: A rigid part having an air inlet opening for receiving breathable pressurized gas, provided to be connected to an elastic part at one end; An elastic part integrally formed with the rigid part, including an elastic part main body that at least partially contacts the patient's face during use and forms a seal, and a connecting part that forms a connection with the rigid part; Wherein the elastic part main body has at least three different wall thicknesses and at least two surface treatment methods, at least including: An adjustment area having an opening close to the patient's face and an edge part adjacent to the opening, wherein at least part of the surface treatment method of the edge part is polishing treatment; A support area configured to be connected to the connecting part of the elastic part, having a wall thickness thicker than the adjustment area at the top adjacent to the adjustment area, for preventing the patient's nose from touching the bottom during use; A stable region, adjacent to and connected with the support region, has a wall thickness thicker than that of the adjustment region.

12. The patient interface pad according to claim 11, wherein The support region has a gradually changing wall thickness at the top adjacent to the adjustment region, where the wall thickness closer to the connection part is thicker.

13. The patient interface pad according to claim 11, wherein The maximum width of the adjustment region at the top of the patient interface pad for accommodating the nose does not exceed 5.5 cm.

14. The patient interface pad according to claim 11, wherein The part of the adjustment region in contact with the patient's nose during use has an inward depression, configured to better accommodate the patient's nose and form a seal.

15. The patient interface pad according to claim 11, wherein, The stable region is the region with the least proportion in the elastic part body of the patient interface pad.

16. A patient interface cushion for use in the CPAP field, which is used to deliver breathable pressurized gas to a patient to treat sleep apnea, characterized in that, The patient interface pad includes: A rigid part, having an air inlet opening for receiving breathable pressurized gas, and is arranged to be connected to the elastic part at one end; An elastic part, integrally formed with the rigid part, includes an elastic part body that at least partially contacts the patient's face during use and forms a seal, and a connection part that forms a connection with the rigid part; Wherein the elastic part body has at least three different wall thicknesses, including: An adjustment region, having an opening close to the patient's face and an edge part adjacent to the opening; A support region, configured to be connected to the connection part of the elastic part, and has a gradually changing wall thickness in a part close to the connection part; A stable region, adjacent to and connected with the support region.

17. The patient interface pad according to claim 16, wherein, The adjustment region includes a nasal side adjustment part with a wall thickness between the edge part and the support region.

18. The patient interface pad according to claim 16, wherein, The width of the edge part of the adjustment region is at most 2 cm.

19. The patient interface pad according to claim 16, wherein, The stable region is the region with the least proportion in the elastic part body of the patient interface pad.

20. The patient interface pad according to claim 16, wherein, The wall thickness changes between different regions of the elastic part body in a step - change manner, and there are obvious demarcation lines between regions.

21. A patient interface pad for use in the CPAP field, which is used to deliver breathable pressurized gas to a patient to treat sleep apnea, characterized in that, The patient interface pad includes: A rigid part, having an air inlet opening for receiving breathable pressurized gas, and is arranged to be connected to the elastic part at one end; An elastic part, having a single - layer wall and integrally formed with the rigid part, includes an elastic part body that at least partially contacts the patient's face during use and forms a seal, and a connection part for connecting with the rigid part; Wherein the elastic part body includes: An adjustment region, having an opening close to the patient's face, an edge part adjacent to the opening, and a nasal side adjustment part close to the edge part with a wall thickness between the edge part and the support region, and the wall thickness of at least part of the adjustment region is at least 0.3 mm; A support region, configured to be connected to the connection part of the elastic part; A stable region, adjacent to and connected with the support region.

22. The patient interface pad according to claim 21, wherein The stable region has a wall thickness thicker than at least part of the adjustment region and the support region.

23. The patient interface pad according to claim 21, wherein, The support region has at least two wall thicknesses, and has a gradually changing wall thickness in a part close to the connection part to achieve a supporting effect.

24. The patient interface pad according to claim 21, wherein, The elastic part has at least three different wall thicknesses.

25. The patient interface pad according to claim 21, wherein, The regions of the elastic part body are smoothly connected without obvious demarcation lines.

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