JP3459764B2 - Respiratory nose mask - Google Patents

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to a respiratory nasal mask. More specifically, CPAP (Continuous Positive Airway Pressure) therapy suitable for treatment of sleep apnea, and NIPPV (Nasal Intermittent) suitable for ventilation failure.
Positive Pressure Ventilation)
The present invention relates to a respiratory nasal mask having a shape and size suitable for Japanese people.

[0002]

BACKGROUND ART Nasal type continuous positive airway pressure therapy CPAP (Contin) for treating patients with sleep apnea syndrome.
Respiratory Assist Device (hereinafter also referred to as “CPAP device”) in which positive positive air of about 4 to 20 cmH ₂ O is supplied to the nostrils of the user during sleep.
Is adopted.

In using such a device, various mask means for continuously applying a positive pressure to the nostril have been developed.

For example, USP 5,243,971 describes a mask having a thin film swollen by positive pressure as a nasal mask for a CPAP device, and a mask which can be fitted by pressing it against the nose at the time of use. It is disclosed. Further, Japanese Patent Application Laid-Open No. 9-10311 discloses a mask means for treating sleep apnea syndrome, in order to prevent discomfort of the patient and to reduce the weight thereof. A mask covering the space is disclosed.

Many off-the-shelf nasal masks do not reflect the shape of the user's nose and the area around the nose. When worn, when positive pressure gas is supplied, the gas from the interface between the nasal mask and the face is removed. There is a problem that leakage easily occurs. In particular, leakage often occurs around the nasal wing of the user, and especially when the user moves his / her head, the amount of leakage increases.

Further, even in a nasal mask using a thin film that can be easily deformed, its shape does not reflect the shape of the nose and the periphery of the nose, so that the thin film portion is forced to be deformed when worn, and the thin film on the thin film Wrinkles occur somewhere. Even if the positive pressure gas is supplied into the nasal mask, the wrinkles generated in the thin film are not easily eliminated, and gas leaks through the wrinkles.

The nasal mask made of such a thin film has a property that it is easily deformed when a load is applied, so that the wearer's wearing state collapses only by moving the head of the user, and lacks stability. ing. Even in the mask means described in Japanese Patent Laid-Open No. 9-10311, it cannot be said that the mask stability is sufficient when the head moves due to its small shape.

Gas leakage from the interface between the nasal mask and the face causes discomfort to the user's face, and if the amount of leakage increases, the therapeutic effect itself decreases. Further, when gas leaks around the root of the nose (near the left and right eyes of the nose), it causes irritation to the eyes of the user.

To solve this problem, it is possible to temporarily prevent gas leakage from the interface between the nasal mask and the face by strongly pressing the nasal mask against the face, but the site where the user wears the nasal mask is damaged. Occurs, and long-term use becomes impossible.

Further, when the nasal mask is made of a relatively strong material so as to be stable on the face, the user's skin will be damaged at the contact portion between the nasal mask and the face when worn.

[0011]

SUMMARY OF THE INVENTION The present invention is an improved breathing system capable of delivering positive pressure gas for breathing through a patient's nose to Japanese patients in need of positive pressure ventilatory support therapy (CPAP, NIPPV, etc.). It is intended to provide a nose mask.

Considering the therapeutic effect on the patient who is the user of the nasal mask, the nasal mask does not cause pain or discomfort to the user and does not damage the skin of the user, and the interface between the nasal mask and the face. There is a need for a nasal mask that minimizes gas leakage from the user and that can be applied to any movement of the user during sleep and that is stable on the user's face. .

Further, since the nasal mask is a consumable item, it is desired that the nasal mask is not custom-made for individual use but can be applied to most Japanese users in several sizes.

[0014]

[Means for Solving the Problems] In order to achieve the above-mentioned object, the present inventor has conducted diligent studies and as a result, has a thin film capable of covering at least the periphery of the nose of a user, and the thin film has a nostril of the user. A mask-holding elastic with a hole through which positive pressure gas for breathing can be sent, and the nasal mask is mounted inside the thin film as seen from the user side so as to be stable on the user's face. In a respiratory nasal mask having a body, the shape of the portion corresponding to the lower nose of the elastic body for holding the mask reflects the general shape of the lower nose of the user, and corresponds to the root of the nose of the elastic body for holding the mask. By applying a shape that does not apply pressure to the nose root of the user, and the shape of the part corresponding to the nose root of the thin film reflects the shape of the general nose root of the user, It was found to solve the problem.

That is, according to the present invention, the user of the nasal mask is set as an adult Japanese person, and the nose mask is attached to the face of the user so as to be stable. When the nasal mask is looked up from below, the shape of the part corresponding to is a shape having an arcuate depression having a radius of curvature of 30 mm or more and 40 mm or less, and a straight line connecting both end points of the arc is 50 mm or more, A respiratory nasal mask having a size of 60 mm or less is provided.

Further, the shape of the portion corresponding to the root of the nose of the elastic body for holding the mask is formed by the portion for holding the outer side of the nose of the user when the nose mask is looked down from above. From the surface, a recess having a depth of 10 mm or more and 20 mm or less is formed, and the width of the recess is 20 mm or more, 30
The present invention provides a respiratory nasal mask having a size of not more than mm.

Further, according to the present invention, when the shape of the portion corresponding to the nose root portion of the thin film capable of covering at least the periphery of the user's nose is such that when the nasal mask is looked down from above, the respiratory nasal mask is It is intended to provide a respiratory nasal mask characterized in that a dent is formed at a depth of 5 mm or less from a surface formed by a portion that holds the lateral outside of the nose.

[0018]

BEST MODE FOR CARRYING OUT THE INVENTION The nasal mask of the present invention prevents gas from leaking from the interface between the nasal mask and the user's lower nose and keeps the nasal mask stable on the user's face. For this, the shape of the part of the nasal mask that contacts the lower nose of the user is important. That is, by conforming the shape of the elastic body for holding the mask corresponding to the lower part of the user's nose to the shape of the user, especially the Japanese at that position, the wrinkle of the thin film is minimized, and the mask is used with the nasal mask. It is possible to prevent gas from leaking from the interface with the worker.

Further, by holding the lower part of the nasal mask below the nose of the user and outside the maximum width of the nose, the wearing position of the nasal mask can be maintained even when the head is rotated left and right. The gap can be prevented. In order to contact the lower part of the mask holding elastic body to the user through the thin film on the left and right below the nose of the user and outside the maximum nose width, the part corresponding to the lower part of the nose of the mask holding elastic body Must have a concave shape, and the width of the portion of the elastic body for holding a mask corresponding to the lower part of the nose must be wider than the maximum width of the nose of the user.

Further, according to the present invention, in order to prevent the user's nose root from being damaged, the mask holding elastic body is prevented from hitting the user's nose root area, and only the thin film portion is in the nose root area. It is a nose mask that comes into contact with.

In order to prevent gas leakage around the nose root, the shape of the thin film around the nose root needs to reflect the general shape around the nose root of the user. Since it is assumed that the uppermost part of the worn portion of the respiratory nasal mask according to the present invention is near the straight line connecting the inner canthus of the user, the thin film portion corresponding to the root of the nose must be provided with a depression. However, if the recess is too deep, a gap is created between the user and the thin film, which causes gas leakage.

The inventor of the present invention has decided to determine the shape and size of the portion corresponding to the lower nose of the elastic body for holding the mask of the above-mentioned nasal mask and the portion corresponding to the root of the nose of the thin film. The shape of the lower nose (near the lowest point of the nose and the middle of the upper lip) and the root of the nose between the inner canthus of 200 people (100 men and 100 women) was investigated.

As a result of investigating the vicinity of the lower part of the nose of an adult Japanese, the cross-section in the lateral direction of the face in the region near the lowest point of the nose and the middle of the upper lip is such that it connects the edge of the nose blade to the end of the lip on the face. It was found that 90% or more of the men and 65% or more of the surveyed men were formed within the radius of curvature of 30 mm to 40 mm by forming an arc shape between the left and right wrinkles existing in the above.

Further, in the case of the Japanese subject to be surveyed whose lower nose has a radius of curvature within the range, about 70% of males and about 50% of females are in a straight line length of 50 mm to 60 mm connecting both end points of the arc. It was found that the percentage entered. Of course, the straight line length exceeds the maximum width of the nose of the entire survey target.

Further, as a result of the shape investigation of the nasal root portion between the inner canthus of an adult Japanese, the protrusion of the nasal root portion at the location (the maximum height of the nasal root portion from the straight line connecting the two inner canthus to the front of the face) 90% of all surveyed objects within 5 mm to 10 mm
We have found that the above can be entered. In addition, it was found that the width of the root of the nose at the location was 20 mm or less in about 70% of the entire survey target.

Based on the above results, the shape of the part corresponding to the lower part of the nose and the root of the nose of the elastic member for holding the mask and the shape of the part corresponding to the part of the nose of the thin film described above were determined as follows. By deciding as shown in the example, the inventors have found a breathing nasal mask that is excellent in stability when worn and does not leak gas.

The respiratory nasal mask of the present invention is formed of a stretchable material such as silicone rubber so that the thin film portion has a concave shape in which the central portion reflects the nose shape when viewed from the user side. Seen from the perspective, the contour is an isosceles triangle with rounded corners, and the membrane is pierced with an appropriate location and size to deliver positive pressure gas for breathing to the user's nostrils. The inner surface of the concave thin film when viewed from the user side has a shape that makes it easy to get caught inside the nasal mask when pressed so that the nasal mask can maintain stability on the user's face. It is suitable for a nasal mask to which an elastic body for holding a mask formed of a material such as silicone rubber is attached.

The nasal mask, in which the user side of the nasal mask is formed of a thin film, has the flexibility of the material for forming the thin film.
When positive pressure gas is supplied into the nasal mask, the thin film portion can self-adapt to the shape of the wear site of the user. Therefore, under the supply of positive pressure gas, the thin film portion can almost completely seal the interface between the nasal mask and the face, and gas leakage can be minimized.

Further, the nasal mask having the elastic body for holding the mask can minimize the amount of deformation of the nasal mask itself even if the head of the user moves, and any movement during sleep of the user. Also, the feature is that it is possible to minimize gas leakage at the interface between the nose mask and the face.

In the present invention, the shape of the portion corresponding to the lower part of the nose of the elastic body for holding a mask has a shape having an arcuate recess having a radius of curvature of 30 mm to 40 mm when the nasal mask is looked up from below. The straight line connecting both end points of the arc is formed to be 50 mm to 60 mm.

Further, the shape of the portion corresponding to the nose root portion of the mask holding elastic body is formed by the portion which holds the outside of the nose of the user when the nasal mask is looked down from above. From the surface to be recessed at a depth of 10 mm or more and 20 mm or less, and the width of the recess is 20 mm or more and 30 mm or more.
It is formed so as to be less than or equal to mm.

The tip of the mask-holding elastic body can be curled inward so that it can be easily deformed when the mask is attached. In such a case, the inner diameter of the mask-holding elastic body tends to be small. The invention of the present application excludes such a thinly formed portion so that it can be easily deformed, and has a radius of curvature, a straight line length, and a radius of a portion substantially corresponding to the lower part of the user's nose.
It means the depth and width of the recess substantially corresponding to the root of the user's nose.

The elastic member for holding the mask is formed of an elastic material such as silicon rubber, and the thickness thereof is, for example, about 0.5 mm on the face side of the user, but on the end portion on the side opposite to the face. It is continuously changed such as about 5 mm. The tip portion of the elastic body for holding the mask, which is on the face side of the user, is lightly curled inward so that the tip portion can be easily deformed so as not to cause pain on the face of the user even when pressed. If the shape of the part corresponding to the lower part of the nose of the user is formed to be the average shape of the Japanese user, even if a user with a slightly different nose shape uses the nasal mask, it will occur. The gap is suitable for most Japanese because the stretchable thin film connected to the mask holding elastic body can completely seal the gap.

Further, in the present invention, when the shape of the portion corresponding to the nasal root of the thin film is looked down from above the nasal mask, the nasal mask for breathing is formed by the portion which holds the left and right outer sides of the nose of the user. The surface is formed so as to have a recess at a depth of 0 to 5 mm. In particular, if the thin film indentation at the location corresponding to the nose root of the user, which is a problem, is formed shallower than the general height of the nose root of the Japanese user, the material forming the thin film can expand and contract. Depending on the sex, unless the user's nose root reaches the elastic body for holding the mask,
Even if a user with a high nasal root wears a nasal mask, the thin film can easily adapt to the shape of the nasal root of the user.

In the method for forming the concave shape of the thin film, for example, a representative person is first selected from the users, and the nose pattern of the person is taken with gypsum or the like. The taken nasal mold has a concave shape, and a thin film concave shape may be formed based on the nasal mold. Of course, select some nose-shaped representatives,
Multiple sizes may be created, and a person other than the user may be selected as the nose-type representative. Also, if you have some data about the nose without using the actual person's nose,
A thin film may be formed based on it. The thin film is made of a material that easily expands and contracts, such as thin silicon rubber, and has a film thickness of 0.
It is formed with a thickness of about 1 to 0.3 mm. However, for the part corresponding to the nose root of the thin film, the depth of the depression is 0-5.
The mold for forming the thin film is modified to have a thickness of mm.

[0036]

EXAMPLE 1 FIG. 1 shows an example of use of a respiratory nasal mask 1. FIG. 2 is a front view of the user 6,
The wearing part 13 of the nasal mask 1 is shown. The respiratory nasal mask 1 according to the present invention is used by being connected to a positive pressure gas supply device 4 via a mask shell 2 and a positive pressure gas supply tube 3. The nasal mask 1 can be fixed to the nasal mask wearing portion 13 of the user 6 by attaching some adjustable straps 5 to the mask shell 2. The mask shell 2 is provided with an expiratory discharge hole 7. In addition, the arm 8 extending from the upper portion of the mask shell 2 in the forehead direction of the user 6
Of the nasal mask 1 on the face of the user 6 by connecting the forehead to the tip of the user 6 and attaching a forehead pad 9 of height adjustable, which is made of a flexible material that can be in close contact with the forehead of the user 6. Stability is further increased.

FIG. 3 shows a respiratory nasal mask 1 according to the present invention.
Fig. 4 is a perspective view of the appearance of a preferred example of the present invention expressed by a wire frame. Fig. 4 is a schematic view of the appearance of the preferred example projected on a plane. It is an external appearance schematic diagram in which only the body is taken out and projected in a plane.

When viewed from the side of the user 6, the thin film 10 whose central portion has a concave shape reflecting the general nose shape of the user,
In the vicinity of the connection portion with the mask shell 2, it is bonded to the mask holding elastic body 11. The thin film 10 and the elastic body 11 for holding the mask are molded from silicone rubber. The thin film 10 is 0.
The thickness of the mask holding elastic body 11 is 2 mm.
It is continuously changed so that the face side is 0.6 mm and the opposite side is 4 mm. The thin film 10 also has a suitable position so that breathing gas can be delivered to the nostrils of the user 6,
It has a hole 12 of a size.

The depression of the thin film in the portion corresponding to the root of the user's nose is set to have a depth of 4 mm as shown in FIG. The depression of the elastic body for holding the mask at the location corresponding to the root of the user's nose
As shown in FIG. 6, the depth is 15 mm and the width is 25 mm. The depression of the elastic member for holding the mask corresponding to the lower part of the nose of the user has an arc shape with a radius of curvature of 35 mm as shown in FIG. 6, and the straight line length connecting both end points of the arc is 60 mm.

The respiratory nasal mask thus prepared was attached to 7 adult Japanese males, and the 2
As a result of supplying positive pressure air of 0 cmH2O, no air leakage was observed.

[Comparative Example 1] With respect to the same breathing nasal mask as in Example 1, the radius of curvature of the portion of the elastic member for holding the mask corresponding to the lower part of the nose of the user was 45 mm, and the linear length was 65 mm. I created what I did. When this nasal mask for breathing was attached and positive pressure air was supplied by the CPAP device as in Example 1, air leakage from the lower nose occurred.

[Comparative Example 2] A respiratory nasal mask similar to that of Example 1 was used, in which the depression shape of the mask holding elastic body corresponding to the user's nose root had a depth of 25 mm and a width of 40 mm. It was created. It has been found that the mask is displaced when the head is moved while wearing the respiratory nasal mask.

[Comparative Example 3] With respect to the same respiratory nasal mask as in Example 1, a respiratory nasal mask was prepared in which the depth of the depression at the portion corresponding to the root of the nose of the thin film of the mask was 10 mm. When this nasal mask for breathing was put on and positive pressure air was supplied by the CPAP device, air leakage from the root of the nose occurred and the air irritated the eyes.

[0044]

EFFECTS OF THE INVENTION The breathing nasal mask according to the present invention has a thin film on the surface of the nasal mask, which causes an unreasonable deformation by making the contact surface with the user into a shape reflecting the nose shape of the Japanese user. No wrinkles are formed on the thin film as compared with the conventional respiratory nasal mask. Regarding gas leakage from the root of the nose, which is particularly problematic when using a nasal mask, by forming the shape of the part corresponding to the root of the thin film to be shallower than the height of the general Japanese nose, It can be solved by flexibility.

Since this thin film can be inflated like a balloon by supplying positive pressure gas, the shape of the portion corresponding to the lower part of the nose of the elastic member for holding the mask is the average shape of the Japanese user. With this structure, even if there is a gap between the user and the elastic body for holding the mask, it is possible to completely seal the site where the user wears the nose mask.

Further, due to the presence of the mask holding elastic body having a portion corresponding to the lower part of the user's nose formed in an average Japanese shape and size, the nasal mask is deformed even if the user's head moves. The amount can be minimized.

Therefore, the nasal mask according to the present invention can cope with any movements of the user during sleep, and the user does not need to press it so strongly that the user feels pain or discomfort in the face. Gas leakage at the interface between the mask and the face can be prevented.

That is, according to the present invention, it is possible to maximize the therapeutic effect on Japanese nasal mask users who need positive pressure ventilation therapy (CPAP, NIPPV, etc.).

[Brief description of drawings]

FIG. 1 is a schematic view of an example of using a respiratory nasal mask.

FIG. 2 is a schematic view of a site where a nose mask for breathing is worn.

FIG. 3 is an external perspective view of a respiratory nasal mask.

FIG. 4 is a schematic view of a breathing nose mask.

FIG. 5 is a perspective and sectional schematic view of a respiratory nasal mask.

FIG. 6 is a schematic external view of a mask holding elastic body.

[Explanation of symbols]

1 nose mask for breathing 2 mask shell 3 Positive pressure gas supply tube 4 Positive pressure gas supply device 5 straps 6 users 7 Exhalation hole 8 arms 9 forehead pad 10 thin film 11 Mask holding elastic 12 Gas supply hole 13 Nose mask wearing area 14 User's lower part corresponding to the nose 15 User's nose root corresponding part

Continuation of front page (56) Reference JP-A-52-100794 (JP, A) JP-A-9-10311 (JP, A) JP-A-60-227770 (JP, A) Actual development Sho-52-76695 (JP , U) International Publication 97/9090 (WO, A1) (58) Fields investigated (Int.Cl. ⁷ , DB name) A61M 16/00 A61M 16/06 A62B 18/02

Claims (3)

(57) [Claims] 1. Since the positive pressure gas for breathing is supplied to the user's face in contact with the user's face, at least the periphery of the user's nose can be covered, and the nostril of the user can be breathed. A breathing nasal mask having a thin film having a hole capable of sending a positive pressure gas, and an elastic body for holding the mask on the side opposite to the user surface of the thin film, for holding the mask corresponding to the lower part of the user's nose The lower shape of the elastic body has a radius of curvature of 30 mm or more, 4
A respiratory nasal mask having an arcuate dent shape of 0 mm or less and having a straight line connecting both end points of the arc of 50 mm or more and 60 mm or less. 2. The depth of the upper part of the mask holding elastic body corresponding to the user's nose root from the surface formed by the part holding the left and right outer sides of the nose of the user of the breathing nasal mask. Is a dent shape of 10 mm or more and 20 mm or less, and the width of the dent is 20 mm or more and 30 mm or less, The respiratory nasal mask according to claim 1. 3. A depth of not more than 5 mm from the surface of the thin film corresponding to the nose root of the user, which is formed by the portion of the respiratory nasal mask that holds the left and right outer sides of the nose of the user. The nasal respiratory mask according to claim 1 or 2, wherein the respiratory nasal mask has a hollow shape.