CN113926039A

CN113926039A - Nasal cushion and patient interface device

Info

Publication number: CN113926039A
Application number: CN202111165553.9A
Authority: CN
Inventors: 王亚杰; 周明钊; 庄志
Original assignee: BMC Tianjin Medical Co Ltd
Current assignee: BMC Tianjin Medical Co Ltd
Priority date: 2021-09-30
Filing date: 2021-09-30
Publication date: 2022-01-14

Abstract

The invention relates to a nasal cushion and a patient interface device, relates to the technical field of treatment of respiratory related diseases, and is used for improving wearing comfort of the patient interface device. The nose opening of the nose pad of the invention surrounds the lower side of the nostril of the user and is fittingly jointed with the periphery of the nostril of the user for sealing through the nose sealing part, so that the nose pad only covers the nose of the user, thereby being lighter, smaller and unobtrusive as a whole, and being fittingly jointed with the periphery of the nostril of the user for sealing, therefore, the sensitive part of the nose of the user, which is stressed, can not be pressed, and in addition, the wearing comfort degree can be further improved because no nose pillow is inserted into the nasal cavity of the patient.

Description

Nasal cushion and patient interface device

Technical Field

The present invention relates to the field of treatment of respiratory-related conditions, and in particular to a nasal cushion and patient interface device.

Background

Respiratory related diseases are accompanied by a range of respiratory disorders, characterized by apneas, hypopneas and hyperpnoea. Examples of respiratory diseases include Obstructive Sleep Apnea (OSA), respiratory insufficiency, obesity, Chronic Obstructive Pulmonary Disease (COPD) and the like. Continuous Positive Airway Pressure (CPAP) therapy, Non-invasive ventilation (NIV) is commonly used to treat the above respiratory diseases. During treatment, a tube need not be surgically inserted into the airway of the user, but rather a therapeutic device (e.g., a ventilator) is used to deliver continuous or varying pressure ventilation via tubing to the airway of the user via a patient interface device worn by the user to assist the user in performing some or all of the respiratory work to maintain a sufficient level of oxygen in the body.

Existing patient interface devices (otherwise known as masks) are generally classified into three types depending on the cushion within: one is a mask that collectively covers and seals the mouth and nose features of a user, otherwise known as a full-face mask; the other is a mask that covers only the features of the user's nose, seals around the user's nose and presses against the bridge of the user's nose, otherwise known as a nasal mask; the third is a mask that covers the bottom of the user's nose and seals around the nostrils, with a pair of protruding nasal pillows that intrude into the user's nostrils, otherwise known as a nasal cushion mask.

Ventilation therapy using such patient interface devices is often lengthy and users often wear masks overnight, thus requiring attention to all conditions during the treatment. Given this, the patient interface device is as comfortable as possible and the seal is as robust as possible. If the user feels that the wearing comfort is not sufficient, the treatment may be rejected, especially if the contact stress on the user's face exceeds the limit borne by the face, so that strangulation, erythema, even ulcers, etc. may occur. If the tightness is not sufficient, it may cause leakage of gas, on the one hand resulting in a pressure lower than the therapeutic value, rendering the treatment ineffective; on the other hand, the leaking air flow may impact the user's face, especially at the sensitive nose bridge or eyes, and may also cause discomfort, resulting in the user refusing the treatment. In addition, the wearing comfort of the mask for the user is the main condition of high and low compliance of the user treatment, and besides the feeling of face stress, the mask also comprises the following steps: size, weight, whether the mask is prominent (meaning that the mask is prominent on the user's face, the user may be mentally displeasing because the user wears the mask like a ill user, and the user's sight is affected), and is expensive. These factors can affect the user's rejection of treatment.

In view of the above, the existing various types of masks have some disadvantages, such as the overall bulkiness and the strong prominence of the full-face mask. Nasal masks cover the nose of the user relatively only, but still press against the user's sensitive nose bridge location. Nasal cushion masks typically have 2 nasal pillows inserted into the nasal cavity of the user, which can cause a reduction in comfort due to the "air jet" effect present in the nasal pillows.

Disclosure of Invention

The invention provides a nasal cushion and a patient interface device, which are used for improving the wearing comfort of the patient interface device.

According to a first aspect of the present invention, there is provided a nasal cushion comprising an upper side, a lower side opposite the upper side, and a circumferential side disposed between the upper side and the lower side, the circumferential side surrounding the upper side and the lower side to form a cavity; the upper side portion includes a face contact portion for contacting a face of a user;

the face contact part comprises a soft middle part and a first side part and a second side part which are positioned at two sides of the middle part, and the first side part and the second side part are connected with the circumferential side parts; the intermediate portion receives the tip and under the nose of the wearer without the intermediate portion passing over the tip of the nose when worn by the wearer.

In one embodiment, the intermediate portion includes a nasal opening in communication with the cavity and a nasal seal surrounding the nasal opening, the nasal opening configured to surround an underside of a user's nostril in response to the nasal cushion being donned by the user and to fittingly fit around the user's nostril for sealing by the nasal seal; wherein the nasal cushion is configured such that there is no grip against the wearer's alar when sealed against the wearer's nasal floor by the pressurized gas.

In one embodiment, the nasal seal deforms to conform around the user's nares in response to an increase in pressure within the cavity.

In one embodiment, the thickness d1 of the first side is equal to the thickness d2 of the second side, and both are 0.6mm to 1.5 mm.

In one embodiment, the nasal seal is a thin film region, and the thickness d3 of the nasal seal is less than or equal to the thickness d1 of the first side.

In one embodiment, the thickness d3 of the nasal seal is 0.3mm to 0.8 mm.

In one embodiment, the circumferential side comprises a rear side configured to face a lip of a user in response to the nasal cushion being donned by the user, the rear side comprising an on-lip contact portion in contact with the user's lip, the on-lip contact portion having a thickness d5 equal to a thickness d3 of the nasal seal portion.

In one embodiment, the rear side portion further comprises a support portion connecting the lip upper contact portion and the lower side portion, the support portion having a thickness d4 greater than a thickness d3 of the nasal sealing portion.

In one embodiment, the thickness d4 of the support is 0.9mm to 2.0 mm.

In one embodiment, the nasal seal is recessed toward the lower side; or

The nasal seal portion is located on the same plane as the first and second side portions.

In one embodiment, the circumferential side further comprises a front side disposed opposite the rear side;

the front side is provided with a first groove mechanism which is concave towards the rear side, and/or

The support portion is provided with a second groove mechanism which is recessed towards the front side portion.

In one embodiment, the first channel means is configured to extend in a direction from the first side portion to the second side portion, and two opposing inner walls of the first channel means have an acute included angle α 1.

In one embodiment, the first channel mechanism is configured to change its acute included angle α 1 in response to the pressure to adaptively adjust the wearing state.

In one embodiment, the first groove means has a thickness of 0.5mm to 1.4 mm.

In one embodiment, the second channel means is configured to extend in a direction from the first side portion to the second side portion, and two opposing inner walls of the second channel means have an acute included angle α 2.

In one embodiment, the second channel mechanism is configured to change its acute included angle α 2 in response to the pressure to adaptively adjust the wearing state.

In one embodiment, the thickness of the second groove means is 0.5mm to 1.4 mm.

In one embodiment, the nasal sealing portion is in smooth transitional connection with the first and second side portions, respectively.

In one embodiment, the nasal seal portion is in smooth transitional connection with the anterior and posterior side portions, respectively.

In one embodiment, the first side portion is in smooth transitional connection with the circumferential side portion;

the second side part is in smooth transition connection with the circumferential side part.

In one embodiment, the lower side includes a base with a bottom opening disposed therein in communication with the cavity, the bottom opening having a sealing structure disposed therein for sealingly connecting the base to a frame of a patient interface device.

In one embodiment, the sealing structure includes at least one protrusion disposed on the bottom opening inner wall, the protrusion sealing by forming an interference fit with the frame.

In one embodiment, the thickness of the sealing structure is greater than the thickness d4 of the support portion.

In one embodiment, the sealing structure is a plastic part or made of silicone rubber.

In one embodiment, the nasal cushion is made of a material such as silicone rubber, foam, thermoplastic elastomer, resin, or textile.

In one embodiment, the substrate is provided with a vent hole having an inner hole diameter smaller or larger than an outer hole diameter of the vent hole.

In one embodiment, the exhaust hole is in the shape of an oblong, a circle, a rectangle or a structure formed by at least two straight lines which are relatively parallel and at least one arc line which directly connects the two straight lines.

In one embodiment, the exhaust holes are arranged in a divergent manner, and the number of the adjacent exhaust holes of each exhaust hole is at most 6.

In one embodiment, the vent holes are disposed on both sides of and distal from the bottom opening.

In one embodiment, there are at most three rows of vent holes on each side of the bottom opening.

According to a second aspect of the present invention, there is provided a nasal cushion comprising a central portion, first and second side portions connected to the central portion on either side thereof, and lower side portions connected to the central portion, the first and second side portions, respectively, the central portion, the first side portion and the second side portion surrounding the lower side portions to form a cavity; the middle portion, the first side portion, and the second side portion include face-contacting portions that contact a face of a user;

the face-contacting portion including a soft middle portion and an upper portion that is more rigid than the middle portion first and second side portions, the face-contacting portion receiving the tip and under the nose of the wearer;

the intermediate portion includes a nasal opening in communication with the cavity, a nasal seal portion and an supralabial region that accommodate the tip and under-nose portions of the nose, the intermediate portion having a uniform membrane thickness, the nasal opening being configured to surround the underside of a user's nostril in response to the nasal cushion being donned by the user and to fittingly fit around the user's nostril for sealing by the nasal seal portion.

In one embodiment, the nasal cushion is configured such that there is no gripping action against the wings of the wearer's nose when sealed against the bottom of the wearer's nose by pressurized gas.

In one embodiment, the thickness d1 of the first side portion, the thickness d2 of the second side portion, and the thickness d3 of the nasal seal portion are all equal.

In one embodiment, the thickness d1 of the first side portion, the thickness d2 of the second side portion, and the thickness d3 of the nasal seal portion are each 0.3mm to 0.8 mm.

In one embodiment, the thickness d1 of the first side and the thickness d2 of the second side are both greater than the thickness d3 of the nasal seal, wherein the thickness d1 of the first side and the thickness d2 of the second side are equal.

In one embodiment, the thickness d1 of the first side and the thickness d2 of the second side are both 0.8mm to 1.5 mm.

In one embodiment, the thickness d3 of the nasal seal is 0.25mm to 0.8 mm.

In one embodiment, the middle portion extends rearwardly to the lower side portion to form a rear side portion configured to face a lip of a user in response to the nasal cushion being donned by the user, the rear side portion including an on-lip contact portion in contact with the lip of the user, a thickness d5 of the on-lip contact portion being equal to a thickness d3 of the nasal sealing portion.

In one embodiment, the thickness d4 of the support is 0.9mm to 2.0 mm.

In one embodiment, the middle portion extends forward to the lower side portion to form a front side portion disposed opposite the rear side portion, the front side portion having a smooth and grooveless surface.

In one embodiment, a thickness of the front side portion near the middle portion is less than a thickness of the front side portion near the lower side portion.

In one embodiment, the thickness on the front side portion near the middle portion is 0.3mm to 0.8mm, and the thickness on the front side portion near the lower side portion is 0.9mm to 2.0 mm.

According to a third aspect of the present invention, there is provided a patient interface device comprising a nasal cushion as described above, and further comprising a frame, the nasal cushion being sealingly connected to the frame.

Compared with the prior art, the nose opening is arranged at the lower side of the nostril of the user and is fittingly attached to the periphery of the nostril of the user through the nose sealing part for sealing, so that the nose opening only covers the nose of the user, the whole nose opening is lighter, smaller and unobtrusive, the nose opening is fittingly attached to the periphery of the nostril of the user for sealing, the sensitive part of the nose of the user, which is stressed, cannot be pressed, and in addition, no nose pillow is inserted into the nasal cavity of the patient, so the wearing comfort level is further improved.

Drawings

The invention will be described in more detail hereinafter on the basis of embodiments and with reference to the accompanying drawings.

FIG. 1 is a schematic perspective view (as viewed from the front side) of a nasal cushion in example 1 of the present invention;

FIG. 2 is a front view (as viewed from the front side) of the nasal cushion in example 1 of the present invention;

FIG. 3 is a top view (as viewed from the upper side) of the nasal cushion in example 1 of the present invention;

FIG. 4 is a bottom view (as viewed from the lower side) of the nasal cushion in example 1 of the present invention;

FIG. 5 is a rear view (from the rear side) of the nasal cushion in example 1 of the present invention;

FIG. 6 is a schematic perspective view (as viewed from the left side) of a nasal cushion in example 1 of the present invention;

FIG. 7 is a cross-sectional view at A-A of FIG. 3;

FIG. 8 is a cross-sectional view of FIG. 3 at B-B;

FIG. 9 is a cross-sectional view of a nasal cushion in embodiment 2 of the present invention;

FIG. 10 is a front view (as viewed from the front side) of the nasal cushion in examples 3 and 4 of the present invention;

FIG. 11 is a schematic perspective view (from the left) of a nasal cushion according to examples 3 and 4 of the present invention;

FIG. 12 is a schematic perspective view (as viewed from the front side) of a nasal cushion in example 5 of the present invention;

FIG. 13 is a schematic perspective view (as viewed from the left) of a nasal cushion in example 5 of the present invention;

FIG. 14 is a top view (as viewed from the upper side) of a nasal cushion in example 6 of the present invention;

FIG. 15 is a front view (as viewed from the front side) of the nasal cushion in example 6 of the present invention;

FIG. 16 is a schematic perspective view (as viewed from the front side) of a nasal cushion in example 6 of the present invention;

FIG. 17 is a bottom view (as viewed from the lower side) of the nasal cushion in example 6 of the present invention;

FIG. 18 is a schematic perspective view (as viewed from the lower side) of a nasal cushion in example 7 of the present invention;

fig. 19 and 20 are schematic diagrams of patient interface devices in an embodiment of the present invention.

FIG. 21 is a schematic diagram of the basic structure of a human nose;

reference numerals:

100,200-nasal cushion;

110, 210-upper side; 111a, 211 a-face contact;

120, 220-lower side; 130, 230-front side; 140, 240-rear side; 150,250-cavity; 260-left lateral part; 270-right side;

111,211-middle section; 112, 212-a first side; 113, 213-second side;

1111, 2111-nasal opening; 1112, 2112-nasal sealing;

121, 221-substrate; 122, 222-bottom opening; 123,223-sealing structure; 124-air vent;

131-a first groove means;

141-supralabial contact; 142-a support portion; 143-second channel means;

300-a patient interface device; 310-a frame; 320-a flexible hose; 330-a headband;

n1-nostril; n2-alar; f-cheek.

Detailed Description

The invention will be further explained with reference to the drawings.

In the existing full-face mask, nasal mask and nasal cushion mask, as for the full-face mask, the cushion can cover the mouth and the nose of a user, so that the nose bridge of the user can be pressed, and the wearing discomfort can be caused; the cushion of the nasal mask also compresses the sensitive portion of the user's face, the "nasal bridge region"; the nasal pillows in the cushion of the nasal cushion mask invade into the nostrils, and discomfort is also caused.

Based on the problems with existing cushions in prior art masks, the present invention provides a nasal cushion and a patient interface device having the same to address the technical problem of discomfort caused by the existing cushion pressing against the nasal bridge region of the user.

In particular, according to a first aspect of the present invention, as shown in fig. 1-8, the present invention provides a nasal cushion for fitting to a patient interface device and for placement on a face of a user to provide pressurized gas to the user for ventilation therapy, the nasal cushion of the present invention being described in terms of various specific embodiments below.

Example 1

As shown in fig. 4-11, the nasal cushion 100 of the present embodiment includes an upper side portion 110, a lower side portion 120 opposite the upper side portion 110, and a circumferential side portion disposed between the upper side portion 110 and the lower side portion 120, the circumferential side portion surrounding the upper side portion 110 and the lower side portion 120 to form a cavity 150, the cavity 150 forming an air bag chamber when pressurized air is provided to a user.

The upper side portion 110 includes a face contact portion 111a for contacting the face of the user. Specifically, the face contact portion 111a includes a middle portion 111 and first and

second side portions

112 and 113 located on both sides of the middle portion 111, and the first and

second side portions

112 and 113 are each connected to a circumferential side portion. It will be appreciated that the first and

second side portions

112, 113 may be of the same or similar construction, or the first and

second side portions

112, 113 may be symmetrically disposed about the middle portion 111 for ease of manufacture.

The middle portion 111 includes a nose opening 1111 in communication with the cavity 150 and a nose seal portion 1112 surrounding the nose opening 1111. Wherein the nasal opening 1111 is configured to surround the underside of the user's nares in response to the nasal cushion 100 being donned by the user and to fittingly conform around the user's nares for sealing by the nasal seal 1112.

Thus, by sealing around the user's nares with the nasal cushion 100 of the present invention, it is possible to reduce the bulk of the patient interface as a whole, making it small, lightweight and unobtrusive, and also without inserting the user's nasal pillows, further improving its comfort.

Further, when pressurized gas is provided to the user, the cavity 150 has a certain pressure inside (e.g., a pressure of 4-25hpa), and thus the nasal seal 1112 is able to expand and deform in response to an increase in pressure within the cavity 150, thereby conforming closely to the circumference of the user's nares. The nasal cushion 100 of the present invention is thus conformed around the user's nares by the dilatant deformation of the nasal sealing portion 1112, thereby eliminating the need for individual nasal variation of the user when designed and manufactured. Thus, even if there are differences in the individual noses of the user, the ease of deformation of the membrane ensures that the nasal seal 1112 fits snugly around the user's nares, thereby improving the sealing and connection stability of the nasal cushion 100 in contact with the user's face.

Alternatively, the nasal seal 1112 is recessed toward the lower side portion 120, such that when the nasal seal 1112 is inflated by pressure within the cavity 150, the nasal seal 1112 will be located in substantially the same plane as the first and second side portions 112, 113 (as shown in phantom in fig. 7, where the nasal seal 1112 is inflated), thereby ensuring that the face contacting portion 111a (intermediate portion 111) rests flat against the bottom of the user's nose without wrapping around the user's alar N2. Therefore, the nasal cushion 100 according to the present invention does not clamp the two sides of the nasal ala of the user to achieve a stable sealing connection, but the nasal sealing portion 1112 is expanded and deformed to fit the nasal sealing portion closely to the circumference of the nostril N1 of the user, so that the nasal cushion 100 according to the present invention does not need to be strictly adapted to the width of the nose (the distance between the two nasal ala, as shown in fig. 21), thereby increasing the population to which the nasal cushion 100 can be adapted and improving the population adaptability. In addition, the absence of the nasal cushion 100 gripping the user's nose may also reduce its contact area with the user's nose, thereby further increasing the wearing comfort.

Preferably, the outermost edge of the nasal sealing portion 1112 does not extend beyond the tip of the user's nose when the user wears the nasal cushion 100, and therefore does not press against the tip of the user's nose to cause discomfort, and also can reduce its bulk.

Further alternatively, the nasal seal 1112 may not be recessed, but may be directly in the same plane as the first and

second sides

112 and 113, i.e., the face-contacting portion 111a may be configured as a planar structure, which enables the expansion sealing effect of the nasal seal 1112 to be more pronounced.

In addition, the nose opening 1111 may be at least one hole, for example, 1 hole, 2 holes or a plurality of holes may be provided, and may be selectively provided according to the requirement.

Referring to fig. 5, the circumferential side portion includes a rear side portion 140 located on the patient side, a front side portion 130 (located on the patient side) located opposite to the rear side portion 140, and left and right side portions between the rear side portion 140 and the front side portion 130. Wherein the rear side portion 140, the front side portion 130, the left side portion and the right side portion may be integrally constructed.

The rear side 140 is configured to face the user's lips in response to the nasal cushion 100 being donned by the user, the rear side 140 including an upper lip contact portion 141 that contacts the user's lips and a support portion 142 that connects the upper lip contact portion 141 with the lower side 120.

The thickness d1 of the first side portion 112, the thickness d2 of the second side portion 113, the thickness d3 of the nose seal portion 1112, the thickness d4 of the support portion 142, and the thickness d5 of the lip contact portion 141 satisfy the following defined formula:

d1 ═ d2, and d5 ═ d3 ≦ d1 ≦ d 4.

That is, the thickness of the first side portion 112 is the same as the thickness of the second side portion 113, and both are greater than the thickness of the nasal seal portion 1112. For example, the thickness d1 of the first side portion 112 and the thickness d2 of the second side portion 113 may be 0.6mm to 1.5mm, preferably 0.8mm to 1.5mm, and more preferably 0.8mm to 1.2 mm. The thickness d3 of the nasal seal portion 1112 may be 0.25mm to 0.8mm, preferably 0.3mm to 0.8mm, and more preferably 0.3mm to 0.5mm, so in this embodiment the thickness of the nasal seal portion 1112 is the smallest and is in the region of the membrane.

Because the first and

second side portions

112, 113 contact the user's face before the nasal seal 1112 when the nasal cushion 100 is worn, the first and

second side portions

112, 113 are important support points for the face when worn and are subjected to a greater force than the nasal seal 1112; and the first side part 112 and the second side part 113 are positioned at both sides of the user's nasal wings, so that the user's stress feeling at the corresponding positions of the first side part 112 and the second side part 113 is not obvious compared with the nasal sealing part 1112, and therefore, the thickness of the first side part 112 and the second side part 113 is set to be larger than that of the nasal sealing part 1112, so that the rigidity of the two parts is stronger than that of the nasal sealing part 1112, thereby effectively distributing the pressure of the nose pad 100 worn on the face to increase the wearing comfort.

The support portion 142 may extend in the circumferential direction, and may form a part of the rear side portion 140, the left side portion, and the right side portion, for example. The support portion 142 is thus required to maintain the overall shape of the cavity 150 so that it retains its shape without collapsing when worn at low pressures and when the nasal cushion 100 is under pressure. The thickness d4 of the support 142 is thus the thickest, for example, 0.9mm-2.0mm, preferably 0.9mm-1.5mm, to ensure a certain rigidity.

The lip contact portion 141 corresponds to an area of the user's face that is sensitive to forces, and therefore the thickness d5 can be the same as the thickness d3 of the nasal seal portion 1112, and thus the lip contact portion 141 is also a thin film area in this embodiment. So as to ensure that the pressing force of the upper lip of the user is small enough when the user wears the mask, and the wearing comfort can be improved.

The front side 130 and the back side 140 may or may not both have channel means provided thereon, or may have channel means provided thereon.

For example, in the present embodiment, the front side 130 is provided with a first groove means 131 recessed towards the rear side 140. The first groove means 131 is configured as a groove having two opposing inner walls with an acute included angle α 1 (which may be 20 ° to 70 °, for example), and the thickness of the first groove means 131 may be 0.5mm to 1.4 mm. Therefore, under the action of low pressure, when the pressure expansion of the nose sealing portion 1112 is not significant and cannot be effectively applied to the nose of the user, the first groove mechanism 131 can provide a certain elastic support for the position near the nose of the user, thereby increasing the sealing force. Meanwhile, by compressing the first groove mechanism 131 (even if the included angle α 1 thereof is reduced), different nasolabial angles of different persons can be adapted compressibly, so that the wearing state can be adapted to be more suitable.

The lower side 120 includes a base 121, a bottom opening 122 disposed in the base 121 in communication with the cavity, and a sealing structure 123 disposed in the bottom opening 122, the sealing structure 123 for sealingly attaching the base 121 to the frame of the patient interface device.

The bottom opening 122 may be triangular, circular, or oval. The base 121 is sealingly and non-rotatably connected to the frame of the patient interface device by a sealing structure 123 therein. The sealing structure 123 may be at least one protrusion on the inner wall of the bottom opening 122 that seals by forming an interference fit with the frame.

Alternatively, the sealing structure 123 may be a plastic member or a higher hardness silicone rubber, which is elastically deformed to be in sealing connection with the frame.

The nasal cushion 100 is preferably made of silicone rubber, but may also be made of foam, thermoplastic elastomer, resin, or textile materials.

Example 2

On the basis of the above embodiment 1, the present invention also provides a modified embodiment, embodiment 2, as shown in fig. 9. Differences from embodiment 1 described above will be mainly described below.

This embodiment differs from embodiment 1 described above in that the thickness d1 of the first side portion 112 is the same as the thickness d2 of the second side portion 113 and is equal to the thickness d3 of the nose sealing portion 1112, i.e., d1 ═ d2 ═ d 3. The thicknesses of the three parts may be, for example, 0.3mm to 0.8mm, so that the whole face contact part 111a may be formed as an air bag as a whole, thereby reducing the stress of the whole face contact part 111a and enhancing the wearing comfort. The nasal cushion 100 of the present embodiment is therefore able to more strongly conform to the facial features of some people with facial abnormalities.

In this embodiment, similar to embodiment 1, the thickness d4 of the supporting portion 142 can be still thicker, for example, d4 ≧ d 3. For example, d4 may be 0.9mm to 2.0mm, and preferably may be 0.9mm to 1.5mm to ensure some rigidity.

The same features and configurations of this embodiment as those of embodiment 1 will not be described again.

Example 3

On the basis of the above embodiment 1, the present invention also provides a modified embodiment, embodiment 3, as shown in fig. 10 and 11. Differences from embodiment 1 described above will be mainly described below.

This embodiment is different from embodiment 1 described above in that, in addition to the first groove means 131 recessed toward the rear side portion 140 being provided on the front side portion 130, the second groove means 143 recessed toward the front side portion 130 is provided on the support portion 142. The second channel means 143 may also be configured as a groove having two opposing inner walls with an acute included angle α 2 (which may be 20 ° to 70 °, for example), and the thickness of the second channel means 143 may be 0.5mm to 1.4 mm. Under low pressure, when the nasal sealing portion 1112 is not significantly expanded under pressure to effectively fit the nasal characteristics of the user, the groove can provide a certain elastic support for the position near the upper lip of the user, thereby increasing the sealing force; meanwhile, the first groove mechanism 131 (even if the included angle α 1 thereof is reduced) and the second groove mechanism 143 (even if the included angle α 2 thereof is reduced) can be compressed to adapt to different nasolabial angles of different people, so that the wearing state can be adjusted to be more suitable.

Example 4

On the basis of the above embodiment 2, the present invention also provides a modified embodiment, embodiment 4, as shown in fig. 10 and 11. Differences from embodiment 2 described above will be mainly described below.

This embodiment is different from embodiment 2 described above in that, in addition to the first groove means 131 recessed toward the rear side portion 140 being provided on the front side portion 130, the second groove means 143 recessed toward the front side portion 130 is provided on the support portion 142. The second channel means 143 may also be configured as a groove having two opposing inner walls with an acute included angle α 2 (which may be 20 ° to 70 °, for example), and the thickness of the second channel means 143 may be 0.5mm to 1.4 mm. Under low pressure, when the nasal sealing portion 1112 is not significantly expanded under pressure to effectively fit the nasal characteristics of the user, the groove can provide a certain elastic support for the position near the upper lip of the user, thereby increasing the sealing force; meanwhile, the first groove mechanism 131 (even if the included angle α 1 thereof is reduced) and the second groove mechanism 143 (even if the included angle α 2 thereof is reduced) can be compressed to adapt to different nasolabial angles of different people, so that the wearing state can be adjusted to be more suitable.

Example 5

On the basis of the above embodiments 1 and 2, the present invention also provides a modified embodiment, embodiment 5, as shown in fig. 12 and 13. Differences from the above-described embodiments 1 and 2 will be mainly described below.

This embodiment differs from embodiments 1 and 2 described above in that the first channel means 131 on the front side 130 is eliminated. I.e., neither the front side 130 nor the back side 140 in this embodiment is provided with a channel means, and optionally the thickness of the front side 130 may be 0.3mm-0.8mm, i.e., the thickness of the front side 130 is the same as the thickness of the nasal seal 1112, and is all a thin film region.

Optionally, a portion of the front side 130 has a thickness that is the same as the thickness of the nasal seal 1112, and may be, for example, 0.3mm to 0.8 mm. And the thickness of another portion of the front side portion 130 is the same as that of the supporting portion 142, and may be, for example, 0.9mm to 2.0mm, and preferably 0.9mm to 1.5mm, to ensure a certain rigidity.

Example 6

As shown in fig. 14-17, the nasal cushion 200 of the present embodiment includes an upper side portion 210, a lower side portion 220 opposite the upper side portion 210, and a circumferential side portion disposed between the upper side portion 210 and the lower side portion 220, the circumferential side portion surrounding the upper side portion 210 and the lower side portion 220 to form a cavity, the cavity 250 forming an air bag chamber when pressurized air is provided to a user. Further, the upper side portion 210 includes a face contact portion for contacting the face of the user.

The face contact portion includes a middle portion 211 and first and

second side portions

212 and 213 located at both sides of the middle portion 211, and the first and

second side portions

212 and 213 are connected to circumferential side portions. It will be appreciated that the first and

second side portions

212, 213 may be of the same or similar construction, or the first and

second side portions

212, 213 may be symmetrically disposed about the middle portion 211 for ease of manufacture.

Wherein the middle portion 211 includes a nasal opening 2111 in communication with the cavity 250 and a nasal seal 2112 surrounding the nasal opening 2111, the nasal opening 2111 configured to surround the underside of a user's nostril in response to the nasal cushion 200 being donned by the user, and to fittingly fit around the user's nostril for sealing via the nasal seal 2112.

The nasal cushion 200 of the present invention, by sealing against and around the underside of the user's nares, thus, reduces the bulk of the patient interface as a whole, making it small, lightweight and unobtrusive, and also without being inserted into the user's nasal pillows, further improving comfort.

Further, when pressurized gas is provided to the user, the cavity 150 has a pressure inside (e.g., a pressure of 4hpa to 25hpa), and thus the nasal seal 2112 is able to deform to conform around the user's nares in response to an increase in pressure within the cavity 250. The nasal cushion 200 of the present invention is thus conformed around the user's nares by the dilatant deformation of the nasal seal 2112, thereby eliminating the need for individual nasal variation of the user when designed and manufactured. Thus, even if there are differences in the individual noses of the users, the ease of deformation of the membrane ensures that the nasal seal 2112 fits snugly around the user's nares, thereby improving the sealing and connection stability of the nasal cushion 200 in contact with the user's face.

Alternatively, the nasal seal portion 2112 is recessed toward the lower side portion 220, so when the nasal seal portion 2112 is inflated by pressure in the cavity 250, the nasal seal portion 2112 will be in approximately the same plane as the first and second side portions 212, 213 (as shown in phantom at the point where the nasal seal portion 2112 is inflated), thereby ensuring that the face contacting portion 211a (intermediate portion 211) rests flat on the bottom of the user's nose without wrapping around the user's alar. Therefore, the nasal cushion 200 according to the present invention does not clamp the two sides of the nasal ala of the user to achieve a stable sealing connection, but the nasal sealing portion 2112 expands and deforms to make the nasal cushion closely fit around the nostril of the user, so that the nasal cushion 200 according to the present invention does not need to be strictly adapted to the width of the nose (the distance W between the two nasal ala sides) of the user, thereby increasing the population to which the nasal cushion 200 can be adapted and improving the population suitability. In addition, the absence of the nasal cushion 200 gripping the user's nose may also reduce its contact area with the user's nose, thereby further increasing comfort.

Preferably, the distance L between the outside of the nasal seal 2112 and the center of the nasal opening 2111 is no greater than the user's septum to tip height. That is, when the user wears the nasal cushion 200, the outermost edge of the nasal sealing portion 2112 does not exceed the tip of the nose of the user, and therefore does not press the tip of the nose of the user to cause discomfort, and also can be reduced in volume.

Further alternatively, the nasal sealing portion 2112 may not be recessed, but may be directly in the same plane as the first and

second side portions

212, 213, i.e., the face-contacting portion 211a may be configured as a planar structure, which may make the expansion sealing function of the nasal sealing portion 2112 more pronounced.

Further, the nose opening 2111 can be at least one hole, for example, 1 hole, 2 holes, or a plurality of holes can be provided, optionally as desired.

The circumferential side portion includes a rear side portion 240, a front side portion 230 disposed opposite to the rear side portion 240, and a left side portion 260 and a right side portion 270 between the rear side portion 240 and the front side portion 230. The important difference between this embodiment and the above-described embodiments 1-5 is that the nose seal portion 2112 in this embodiment extends forward to the front side portion 230 and rearward to the rear side portion 240, respectively, and the junction between the nose seal portion 2112 and the front and

rear side portions

230 and 240 is a continuous curved surface, or the junctions thereof may be offset from each other.

Preferably, the nasal sealing portion 2112 extends forwardly to the front side 230, rearwardly to the rear side 240, respectively, and is integral, i.e., medial, with the front side 230 and the rear side 240, such that the medial portion has a uniform thickness. I.e., the nose seal portion 2112 has a thickness d3 that is the same as the thickness of the front and

rear side portions

230, 240. For example, d3 may be 0.3mm to 0.9mm, preferably 0.3mm to 0.5mm, i.e. the middle portion is the membrane region (the region shown in dashed lines in the figure).

It will be appreciated that the thickness d5 of the corresponding lip contact portion and the thickness d4 of the support portion on the rear side portion 240 are the same, and are also the same as the thickness d3 of the nose sealing portion 2112, i.e., d 3-d 4-d 5.

Further, the first side portion 212 extends to the left side portion 260, the second side portion 213 extends to the right side portion 270, and the connection positions between the first side portion 212 and the left side portion 260 and the connection positions between the second side portion 213 and the right side portion 270 are continuous curved surfaces, or the connection positions may be mutually displaced.

Preferably, the first side portion 212 extends to be integral with the left side portion 260 and the second side portion 213 extends to be integral with the right side portion 270, i.e., a peripheral portion having a uniform thickness. Therefore, the thickness d1 of the first side portion 212 is the same as the thickness of the left side portion 260 and the thickness d2 of the second side portion 213 is the same as the thickness of the right side portion 270, so that the whole formed body has a uniform thickness, which is larger than the thickness d3 of the nose sealing portion 2112, i.e., d1 ≧ d 3. For example, d1 and d2 may each be from 0.6mm to 1.5mm, preferably from 0.8mm to 1.2 mm.

That is, in this embodiment, the rigidity of the peripheral portions (left side portion 260, right side portion 270, first side portion 212, and second side portion 213) is greater than the rigidity of the intermediate portions (nose sealing portion 2112, front side portion 230, and rear side portion 240). This is because the peripheral portion is an important support point of the face of the user when the nasal cushion 200 is worn, and is more stressed than the middle portion corresponding to the nose of the user, and the peripheral portion is closer to the cheek muscle of the user, so that the user feels less stressed, and thus the rigidity thereof is set to be greater than that of the middle portion, which can effectively distribute the pressure of the facial wear cushion, and increase the wearing comfort.

The lower side 220 includes a base 221, the base 221 having a bottom opening 222 disposed therein that communicates with the cavity, the bottom opening 222 having a sealing structure 223 disposed therein, the sealing structure 223 for sealingly attaching the nasal cushion 200 to the frame of the patient interface.

The bottom opening 222 may be triangular, circular, or oval. The base 221 can be sealingly and non-rotatably connected with the frame of the patient interface device by the sealing structure 223 therein. The sealing structure 223 may be a protrusion on the inner wall of the bottom opening 222 that seals by forming an interference fit with the frame.

Alternatively, the sealing structure 223 may be a plastic member or a higher hardness silicone rubber, which is elastically deformed to be in sealing connection with the frame.

The nasal cushion 200 is preferably made of silicone rubber, but may be made of foam, thermoplastic elastomer, resin, or textile materials.

Example 7

On the basis of the above embodiments, the present invention also provides a modified embodiment, embodiment 7, as shown in fig. 21. The present embodiment is different from the previous embodiments in that the substrate 121,221 is provided with an exhaust portion.

Wherein the exhaust part may be an exhaust hole 124 disposed at both sides of the bottom opening 122. The arrangement and size of the vent holes 124 can be set as desired.

For example, the inner hole diameter of the exhaust hole 124 is smaller or larger than the outer hole diameter of the exhaust hole 124, and the exhaust hole having the same inner and outer diameters causes a large noise, so that the inner hole diameter of the exhaust hole 124 is set to be different from the outer hole diameter of the exhaust hole 124, thereby greatly reducing the exhaust noise.

Further, the exhaust hole 124 may be an oblong, circular, or rectangular shape, or a structure formed by at least two straight lines that are parallel to each other and at least one arc line that connects the two straight lines. In the embodiment shown in fig. 21, the exhaust holes 123 are circular.

In addition, the exhaust holes 124 are arranged in a divergent mode, the exhaust holes 123 are arranged in a diffused mode as much as possible, and the number of the exhaust holes 124 adjacent to each exhaust hole 124 is at most 6.

As shown in FIG. 21, the vent holes 124 are disposed on both sides of the bottom opening 122,222 and are disposed away from the

bottom opening

122, 222. There are at most three rows of exhaust holes 124 on each side of the

bottom openings

122, 222. As shown in FIG. 21, the number of exhaust holes 124 in each row is different, such as the smallest number of exhaust holes 124 in the row of exhaust holes 124 closest to the

bottom openings

122, 222.

As shown in fig. 19 and 20, according to a second aspect of the present invention, there is also provided a patient interface device 300 comprising a nasal mask, the nasal cushion 100,200 described above disposed in the nasal mask, and a frame 310 connected to the nasal cushion 100,200 described above. The frame 310 is provided with a headband 330 for fixing with the head of a user.

A flexible conduit 320 is connected between the frame 310 and the pressure device, through which conduit 320 pressurized gas is delivered into the chamber of the nasal mask and then through the

nasal openings

1111,2111 into the airway of the user, so that the sealing structure 123 in the bottom openings 122,222 ensures a sealed connection of the nasal cushions 100,200 and the frame.

While the invention has been described with reference to a preferred embodiment, various modifications may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In particular, the technical features mentioned in the embodiments can be combined in any way as long as there is no structural conflict. It is intended that the invention not be limited to the particular embodiments disclosed, but that the invention will include all embodiments falling within the scope of the appended claims.

Claims

1. A nasal cushion comprising an upper side, a lower side opposite the upper side, and a circumferential side disposed between the upper side and the lower side, the circumferential side surrounding the upper side and the lower side to form a cavity; the upper side portion includes a face contact portion for contacting a face of a user;

2. The nasal cushion according to claim 1, wherein the intermediate portion includes a nasal opening in communication with the cavity and a nasal seal surrounding the nasal opening, the nasal opening configured to surround an underside of a user's nostril in response to the nasal cushion being donned by the user and to fittingly fit around the user's nostril for sealing by the nasal seal; wherein the nasal cushion is configured such that there is no grip against the wearer's alar when sealed against the wearer's nasal floor by the pressurized gas.

3. The nasal cushion according to claim 2, wherein the nasal seal deforms to conform around a user's nares in response to an increase in pressure within the cavity.

4. The nasal cushion according to claim 1 or 2, wherein a thickness d1 of the first side portion is equal to a thickness d2 of the second side portion, and each is 0.6mm-1.5 mm.

5. The nasal cushion according to claim 2 or 3, wherein the nasal sealing portion is a thin film region, a thickness d3 of the nasal sealing portion being less than or equal to a thickness d1 of the first side portion.

6. The nasal cushion according to claim 5, wherein the nasal seal portion has a thickness d3 of 0.3mm to 0.8 mm.

7. The nasal cushion according to claim 5, wherein the circumferential side includes a rear side configured to face a lip of a user in response to the nasal cushion being donned by the user, the rear side including an on-lip contact portion in contact with the lip of the user, a thickness d5 of the on-lip contact portion being equal to a thickness d3 of the nasal sealing portion.

8. The nasal cushion according to claim 7, wherein the rear side portion further comprises a support portion connecting the lip upper contact portion and the lower side portion, the support portion having a thickness d4 greater than a thickness d3 of the nasal sealing portion.

9. The nasal cushion according to claim 8, wherein the support portion has a thickness d4 of 0.9mm-2.0 mm.

10. The nasal cushion according to claim 2 or 3, wherein the nasal sealing portion is recessed toward the lower side; or

11. The nasal cushion according to claim 9, wherein the circumferential side portion further comprises a front side portion disposed opposite the rear side portion;

12. The nasal cushion according to claim 11, wherein the first channel means is configured to extend in a direction from the first side to the second side, two opposing interior walls of the first channel means having an acute included angle α 1.

13. The nasal cushion according to claim 12, wherein the first channel mechanism is configured to change its acute included angle α 1 in response to an applied pressure to adaptively adjust a wearing state.

14. The nasal cushion according to claim 11, wherein the first channel means has a thickness of 0.5mm to 1.4 mm.

15. The nasal cushion according to claim 11, wherein the second channel means is configured to extend in a direction from the first side to the second side, two opposing interior walls of the second channel means having an acute included angle α 2.

16. The nasal cushion according to claim 15, wherein the second channel mechanism is configured to change its acute included angle α 2 in response to an applied pressure to adaptively adjust a wearing state.

17. The nasal cushion according to claim 11, wherein the second channel means has a thickness of 0.5mm to 1.4 mm.

18. The nasal cushion according to claim 2 or 3, wherein the nasal sealing portion is in smooth transitional connection with the first and second side portions, respectively.

19. The nasal cushion according to claim 11, wherein the nasal sealing portion is in smooth transitional connection with the anterior and posterior sides, respectively.

20. The nasal cushion according to claim 1 or 2, wherein the first side portion and the circumferential side portion are smoothly transitionable connected;

21. The nasal cushion according to claim 9, wherein the lower side portion includes a base with a bottom opening disposed therein in communication with the cavity, the bottom opening having a sealing structure disposed therein for sealingly connecting the base to a frame of a patient interface device.

22. The nasal cushion according to claim 21, wherein the sealing structure includes at least one protrusion disposed on an inner wall of the bottom opening, the protrusion sealing by forming an interference fit with a frame.

23. The nasal cushion according to claim 22, wherein a thickness of the sealing structure is greater than a thickness d4 of the support portion.

24. The nasal cushion according to claim 21, wherein the sealing structure is a plastic piece or is made of silicone rubber.

25. The nasal cushion according to claim 1 or 2, wherein the nasal cushion is made of a material such as silicone rubber, foam, thermoplastic elastomer, resin or textile.

26. The nasal cushion according to claim 21, wherein the base is provided with a vent hole having an inner hole diameter that is smaller or larger than an outer hole diameter of the vent hole.

27. The nasal cushion according to claim 26, wherein the vent is oblong, circular, oblong, or a configuration of at least two straight lines that are at least relatively parallel and at least one arc that connects two straight lines.

28. The nasal cushion according to claim 26, wherein the vent holes are in a diverging arrangement, and wherein at most 6 vent holes are adjacent to each vent hole.

29. The nasal cushion according to claim 26, wherein the vent holes are disposed on both sides of and distal from the bottom opening.

30. The nasal cushion according to claim 29, wherein there are at most three rows of vent holes on each side of the bottom opening.

31. A nasal cushion comprising a middle portion, first and second side portions connected left and right of the middle portion, respectively, and a lower side portion connected to the middle portion, the first side portion, and the second side portion, respectively, the middle portion, the first side portion, and the second side portion surrounding the lower side portion to form a cavity; the middle portion, the first side portion, and the second side portion include face-contacting portions that contact a face of a user;

32. The nasal cushion according to claim 31, wherein a thickness d1 of the first side and a thickness d2 of the second side are each greater than a thickness d3 of the nasal sealing portion, wherein the thickness d1 of the first side and the thickness d2 of the second side are equal.

33. The nasal cushion according to claim 32, wherein a thickness d1 of the first side and a thickness d2 of the second side are each 0.8mm-1.5 mm.

34. The nasal cushion according to claim 32, wherein the nasal seal portion has a thickness d3 of 0.25mm to 0.8 mm.

35. The nasal cushion according to claim 31, wherein the nasal cushion is configured such that there is no grip against the alar of the wearer when sealed against the bottom of the wearer's nose by the pressurized gas.

36. The nasal cushion according to claim 31, wherein a thickness d1 of the first side portion, a thickness d2 of the second side portion, and a thickness d3 of the nasal sealing portion are all equal.

37. The nasal cushion according to claim 36, wherein a thickness d1 of the first side portion, a thickness d2 of the second side portion, and a thickness d3 of the nasal sealing portion are each 0.3mm-0.8 mm.

38. The nasal cushion according to claim 37, wherein the middle portion extends rearwardly to the lower side portion to form a rear side portion configured to face a lip of a user in response to the nasal cushion being donned by the user, the rear side portion including an upper lip contact portion in contact with the user's upper lip, a thickness d5 of the upper lip contact portion being equal to a thickness d3 of the nasal sealing portion.

39. The nasal cushion according to claim 38, wherein the rear side portion further comprises a support portion connecting the lip upper contact portion and the lower side portion, the support portion having a thickness d4 greater than a thickness d3 of the nasal sealing portion.

40. The nasal cushion according to claim 39, wherein the support portion has a thickness d4 of 0.9mm-2.0 mm.

41. The nasal cushion according to claim 38, wherein the middle portion extends forward to the lower side portion to form a front side portion disposed opposite the rear side portion, the front side portion having a smooth and grooveless surface.

42. The nasal cushion according to claim 41, wherein a thickness on the anterior portion proximate the middle portion is less than a thickness on the anterior portion proximate the inferior portion.

43. The nasal cushion according to claim 42, wherein a thickness on the anterior portion proximate the medial portion is 0.3mm-0.8mm, and a thickness on the anterior portion proximate the inferior portion is 0.9mm-2.0 mm.

44. A patient interface device comprising the nasal cushion of any one of claims 1-30 or claims 31-43, further comprising a frame, the nasal cushion being sealingly connected to the frame.