Respiratory mask and respiratory mask facility

Abstract

To provide a CPAP mask used for therapy of sleep apnea syndrome, an NPPV mask used for non-invasive and positive pressure ventilation therapy, capable of reducing a pressure applied to the face of a user from a mask control part, or controlling a level of the pressure, and a respiratory mask facility.SOLUTION: A respiratory mask 1 comprises: a prescribed outer dimension deformation body 30 which is held between a face contact part 10 being a part directly contacting the face of a user, and a mask support body 20 laminated on an upper position of the face contact part 10, and whose outer dimension is deformed; and a strap 40 connected to the mask support body 20. A respiratory mask facility 2 has: prescribed pressure adjustment control means 50 connected to the outer dimension deformation body 30 forming the respiratory mask 1, through a pressure adjustment control tube 60; and a respirator tube 70 connected to the mask support body 20.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to respiratory masks, such as CPAP masks used to treat sleep apnea syndrome and NPPV masks used in non-invasive positive pressure ventilation, and respiratory mask equipment using them. [Background technology]

[0002] When a breathing mask such as a CPAP mask or an NPPV mask is worn over the nose or mouth, pressure is applied to the skin in the area that comes into contact with the face, which can cause side effects such as redness or pain on the face of the mask user. In addition, wearing a mask can also cause discomfort and stress (for example, Patent Document 1, etc.).

[0003] Incidentally, an invention has been disclosed that relates to a method for determining a pressure suitable for testing whether a respiratory mask such as a CPAP mask or an NPPV mask is properly fitted, and a method for determining proper mask fitting (Patent Document 2).

[0004] An invention relating to a pressure-regulating syringe has also been disclosed (Patent Document 3). [Prior art documents] [Patent documents]

[0005] [Patent Document 1] International Publication No. 2007 / 111374 [Patent Document 2] JP 2011-36700 A [Patent Document 3] Special Publication No. 2014-528813 Summary of the Invention [Problem to be solved by the invention]

[0006] In order to solve the problems of side effects or discomfort and stress as described above, it has been proposed to attach a wound dressing or the like between the mask and the facial skin to reduce pressure. However, this increases the gap between the mask and the facial skin, increasing the risk of gas leakage, which requires the straps to be tightened, increasing discomfort, and creating new problems such as the skin being torn off when the wound dressing is removed.

[0007] As mentioned above, various medical institutions, mask users, and their caregivers have devised ways to address the problems of side effects and discomfort and stress that come with wearing a respiratory mask, but there is still no solution that can solve everything, and medical professionals and mask users are each coming up with their own solutions.

[0008] Therefore, the first objective of the present invention is to provide a respiratory mask and respiratory mask equipment that allows the pressure on the face when wearing the mask to be determined by the settings of specified devices and instruments, without relying on the sensation of the caregiver or mask user (patient), with the aim of ensuring proper wearing of the respiratory mask.

[0009] Secondly, it is an object of the present invention to provide a respiratory mask and respiratory mask equipment that aims to reduce discomfort and stress caused by changes in the wearing condition of the respiratory mask after wearing it. [Means for solving the problem]

[0010] In order to solve the above problems, the present invention provides a respiratory mask used for treating sleep apnea syndrome, non-invasive positive pressure ventilation therapy, etc., which includes at least a face contact portion which is the portion that comes into contact with a person's face when the mask is worn, a mask support which is positioned above the face and away from the face, and a predetermined external dimension deformation body whose external dimensions are deformed and which is sandwiched between the face contact portion and the mask support, the external dimension deformation body being composed of one or more gas-enclosing molding portions having the function of sealing and maintaining gas inside, and a gas inlet / outlet arranged on the gas-enclosing molding portion, and the gas-enclosing molding portion has an external dimension which expands and becomes larger when gas is introduced into its internal space, and an external dimension which contracts and becomes smaller when gas is released from the internal space.

[0011] In order to solve the above problems, the present invention further provides a respiratory mask in which the gas-enclosing molded portion expands and increases in external dimensions by introducing gas into its internal space, and pulls the mask belt.

[0012] In order to solve the above problems, the present invention further provides a breathing mask in which only one gas inlet / outlet is provided on the outer dimension deformable body.

[0013] In order to solve the above problems, the present invention further provides a respiratory mask equipment which includes a pressure adjustment control means for introducing or releasing gas into or from the gas inlet / outlet constituting the respiratory mask, and temporarily or continuously adjusting or controlling the internal space pressure of the gas-enclosing molded portion, and which connects the pressure adjustment control means and the gas inlet / outlet with a pressure adjustment control tube, and which has an inhalation / exhalation tube inserted into the mask support constituting the respiratory mask.

[0014] In order to solve the above problems, the present invention further provides a respiratory mask equipment in which the pressure adjustment control means is a pressure control device capable of continuously controlling the internal space pressure of the gas-enclosing molding portion.

[0015] In order to solve the above problems, the present invention further provides the breathing mask equipment, further comprising a remote control for operating the pressure control device. Effect of the Invention

[0016] The respiratory mask of the present invention is a respiratory mask used for the treatment of sleep apnea syndrome, non-invasive positive pressure ventilation therapy, etc., and includes at least a face contact portion which is the portion that comes into contact with the person's face when the mask is worn, a mask support which is positioned above the face and away from the face, and a predetermined external dimension deformation body whose external dimensions are deformed and which is sandwiched between the face contact portion and the mask support. The external dimension deformation body is composed of one or more gas-enclosing molding portions having the function of sealing and maintaining gas inside, and a gas inlet / outlet which is disposed on the gas-enclosing molding portion. The gas-enclosing molding portion expands and becomes larger when gas is introduced into its internal space, and contracts and becomes smaller when gas is released from its internal space, thereby assisting in the proper wearing of the respiratory mask and also reducing discomfort and stress caused by changes in the wearing state of the respiratory mask after it is worn.

[0017] Furthermore, the respiratory mask of the present invention is a respiratory mask in which the gas-enclosing molded portion expands and increases its external dimensions by introducing gas into its internal space, thereby pulling the mask belt. This is believed to make it possible to further reduce discomfort and stress caused by changes in the wearing condition of the respiratory mask after it is put on.

[0018] Furthermore, the breathing mask of the present invention has only one gas inlet / outlet on the outer dimensionally deformable body, which is believed to result in a relatively simple structure and reduced manufacturing costs.

[0019] The respiratory mask equipment of the present invention further includes a pressure regulation control means for temporarily or continuously regulating or controlling the internal space pressure of the gas-enveloping molded portion by feeding or discharging gas through the gas inlet / outlet constituting the respiratory mask, and a pressure regulation control tube is connected between the pressure regulation control means and the gas inlet / outlet, and an inhalation / exhalation tube is inserted through the mask support constituting the respiratory mask, thereby realizing proper wearing of the respiratory mask and reducing discomfort and stress caused by changes in the wearing state after wearing the respiratory mask. By using a pressure regulation control tube that is long enough to span between rooms, remote operation (control) is also possible, which can reduce the risk of infectious diseases caused by the exhalation of the respiratory mask wearer.

[0020] The respiratory mask equipment of the present invention further comprises a pressure adjustment control means that is a pressure control device capable of continuously controlling the internal space pressure of the gas-enclosing molded portion, thereby enabling continuous and more stable pressure control, thereby making it possible to reduce discomfort and stress caused by fluctuations in the wearing condition of the respiratory mask after it is worn.

[0021] The respiratory mask equipment of the present invention further includes a remote controller for operating the pressure control device, so that when discomfort or stress occurs due to a change in the wearing state of the respiratory mask after wearing it, the pressure control device can be operated to eliminate the discomfort. Also, it is possible to operate the pressure adjustment control means from a position away from the respiratory mask (a position away from the hospital room where the patient is), which can reduce the risk of infectious diseases caused by the breath of the respiratory mask wearer. [Brief description of the drawings]

[0022] [Figure 1] FIG. 1 is a side view of a respiratory mask according to a first embodiment. [Diagram 2] FIG. 2 is a perspective view showing the overall configuration of the respiratory mask equipment of the first embodiment. [Diagram 3] FIG. 3 is a perspective view of the respiratory mask equipment of the first embodiment (when remotely operated). [Figure 4] FIG. 4 is a perspective view of the respiratory mask equipment of the first embodiment (when remotely operated using a tube extension unit). [Diagram 5] FIG. 5 is a perspective view of the respiratory mask equipment of the first embodiment (when using a wireless remote control). [Figure 6] FIG. 6 is a diagram showing an image of how the respiratory mask of the first embodiment works when worn. [Figure 7] FIG. 7 is a diagram showing an image of the connection operation of the respiratory mask equipment of the first embodiment. [Figure 8] FIG. 8 is a diagram showing how the respiratory mask of Example 1 is worn and how the respiratory mask equipment operates (with the gas-enclosing molded portion inflated). [Figure 9] FIG. 9 is a side view of the respiratory mask of the second embodiment. [Figure 10] FIG. 10 is a diagram showing an image of the operation of the outer dimension deformable body of the second embodiment (in a state where only the nose bridge portion of the gas surrounding molded portion is inflated). [Figure 11] FIG. 11 is a diagram showing an image of the operation of the outer dimension deformable body of the second embodiment (in a state where only the jaw portion of the gas-encircling molding portion is expanded). [Figure 12] FIG. 12 is a side view of the respiratory mask of the third embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] For use as respiratory masks and respiratory mask equipment for patients treated for sleep apnea syndrome or non-invasive positive pressure ventilation. EXAMPLES

[0024] First, the configuration of the breathing mask will be described with reference to Figs.

[0025] The respiratory mask (1) is composed of a face contact portion (10) which is the portion that comes into direct contact with the person's face when the mask is worn, a mask support (20) which is layered above the face contact portion and away from the face, a predetermined outer dimension deformable body (30) whose outer dimensions are deformed which is sandwiched between the face contact portion and the mask support, and a strap (40) which is connected to the mask support in order to maintain the face contact state of the face contact portion (FIGS. 1 and 2).

[0026] With regard to the area covered by the face contact portion (10), the illustration shows a type that covers the nose and mouth but does not cover the eyes, but types that cover only the nose, types that cover the mouth and have a hole below the nose, and types that cover all of the eyes, nose, and mouth are also acceptable.

[0027] The material for the face-contacting portion (10) is preferably one that is wrinkle-resistant, has cushioning properties, is neither too hard nor too soft, and has good biocompatibility.

[0028] The mask support (20) is composed of a mask support base part (21) which is stacked above the face contact part (10), and a respiratory tube connection port (22) which is disposed at the most protruding part of the mask support base part (Figure 1).

[0029] The mask support base 21 is illustrated as being made of a hard material and is transparent, but it may be made of a soft material, an opaque material, or a material having a hole for exhaling (exhalation port).

[0030] The outer dimension deformable body (30) is composed of a gas-enclosing molding section (31) having the function of sealing and maintaining gas inside, and a gas inlet / outlet (32) arranged on the gas-enclosing molding section (Figure 1).

[0031] The gas-enclosing molded portion (31) may have any structure as long as it has the function of sealingly retaining the gas inside, and its external dimensions expand and become larger when air is introduced into the internal space, and contract and become smaller when air is released from the internal space. In this embodiment, the entire portion is molded into a balloon or bag shape using a thin film, thereby realizing the function of sealingly retaining the gas inside and the above-mentioned operation (Figure 1).

[0032] The gas inlet / outlet (32) is an inlet for introducing air into the gas-encircling molding portion (31) and also an outlet for discharging air from the gas-encircling molding portion.

[0033] The straps (40) are required to be stretchable, considering that the breathing mask (1) of the present application is continuously in contact with the face both while it is being worn and after it is put on.

[0034] Next, the configuration of the breathing mask equipment will be described with reference to Figs.

[0035] The respiratory mask equipment (2) comprises at least a pressure adjustment control means (50) for temporarily or continuously adjusting or controlling the pressure in the internal space of the gas-enclosing molded portion by introducing or releasing gas into or from the gas inlet / outlet (32), a pressure adjustment control tube (60) connecting the pressure adjustment control means and the gas inlet / outlet, and an inhalation / exhalation tube (70) inserted into the respiratory tube connection port (22) constituting the mask support (20) (Figure 2).

[0036] The pressure adjustment control means (50) only needs to have the function of temporarily or continuously adjusting or controlling the internal space pressure of the gas-encircling molding section (31). In this embodiment, a pressure control device (51) capable of continuously controlling the internal space pressure of the gas-encircling molding section is additionally connected (Figure 2).

[0037] With regard to the pressure adjustment control means (50), the device (52) capable of temporarily adjusting the internal space pressure of the gas-enclosing molding section (31) refers to, for example, a device capable of manually supplying air (not shown).

[0038] The pressure adjustment control tube (60) refers to a tube that connects the pressure adjustment control means (50) and the gas inlet / outlet (32) in order to inject air into the internal space of the gas-encircling molding section (31) or to exhaust (remove) air from the internal space of the gas-encircling molding section (31) through the gas inlet / outlet (32) (Figure 2).

[0039] Regarding the length of the pressure regulation control tube (60), various lengths of tubes can be used depending on the usage environment and application, but it is assumed that a length of less than about 5 meters will be sufficient when the pressure regulation control means (50) is placed inside the patient's hospital room. On the other hand, when the pressure regulation control means is placed outside the patient's hospital room (in the case of remote operation), it is assumed that a length spanning the room (10 meters or more) will be required (FIGS. 2 and 3).

[0040] When the pressure regulation control means is located outside the patient's room (in the case of remote control), if the length of the pressure regulation control tube (60) is insufficient, it is acceptable to joint two of the pressure regulation control tubes with a tube extension unit (61) and use them as one pressure regulation control tube (Figure 4).

[0041] The respiratory tube (70) refers to a tube for supplying exhaled air to a person (patient) wearing the respiratory mask via the respiratory tube connection port (22) (FIG. 2).

[0042] By adding a remote control (80) for operating the pressure control device (51), it is possible to operate the pressure control device to eliminate discomfort or stress caused by changes in the wearing condition of the breathing mask after wearing it, which is thought to improve operability (Figure 5).

[0043] It is preferable that the remote control (80) has a shape that is easy to grip for the wearer of the breathing mask, buttons that are easy to press, or a design that makes it easy for the operator of the remote control to operate (for example, the pressurization button is marked with "+" and the depressurization button is marked with "-", or the buttons are distinguished by color coding, unevenness, etc.) (FIG. 5).

[0044] The interface between the remote control (80) and the pressure control device (51) may be either wired or wireless, but it is considered that a wireless interface will provide improved operability (FIG. 5).

[0045] In addition, in the case where the remote control is not attached, the strength of the attachment can be changed by adjusting the length of the strap (40).

[0046] Next, the procedure for putting on a breathing mask and the operation of the breathing mask equipment will be described with reference to Figs. 6 to 8 and Figs. 3 to 5.

[0047] When the gas-enclosing molded portion (31) has shrunk to a certain extent, the face contact portion (10) is placed on the patient's face and secured with straps (40) to wear the breathing mask (Figure 6).

[0048] Then, a pressure control device (51) capable of continuously controlling the pressure in the internal space of the gas-enclosing molding section is connected to the gas inlet / outlet (32), and a respiratory tube (70) is connected to the respiratory tube connection port (22) (Figure 7).

[0049] By operating the pressure control device (51) to expand the gas surrounding molding (31), the pressure in the face contact portion is indirectly increased, and the strap (40) is also pulled and stretched (arrows shown in FIG. 8).

[0050] It is expected that the above-described operation will suppress significant fluctuations in the mask position after the breathing mask is put on, and further reduce discomfort and stress caused by fluctuations in the wearing state.

[0051] If it is desired to operate the pressure control device (51) outside the patient's (mask wearer's) room, it is possible to operate it by using a single pressure adjustment control tube (60) long enough to span the room (Fig. 3), by jointing two pressure adjustment control tubes with a tube extension unit (61) to use as a single pressure adjustment control tube (Fig. 4), or by using a wireless remote control (53) (Fig. 5).

[0052] It is also believed possible to suppress changes in the pressure on the face caused by changes in the mask user's position between sitting and lying on their back (for example, the pressure caused by the weight of the mask when lying on their back can be offset by reducing the pressure inside the gas enclosure). EXAMPLES

[0053] The breathing mask of the second embodiment differs from that of the first embodiment in the shape of the gas-enclosing molded portion, and only the different parts will be described with reference to FIG.

[0054] The respiratory mask (1) is composed of a face contact part, a mask support and a strap similar to those of the respiratory mask of Example 1, and a predetermined outer dimension deformable body (30) whose outer dimensions are deformed and sandwiched between the face contact part and the mask support. The outer dimension deformable body is composed of two gas-enclosing molded parts (31) having the function of sealing and maintaining gas therein, and a gas inlet / outlet (32) arranged on each of the gas-enclosing molded parts (Figure 9).

[0055] The gas surrounding molded portion (31) is arranged on the bridge of the nose and the chin (FIG. 9).

[0056] The number of the gas inlet / outlet ports (32) is one on each of the gas surrounding moldings (31) (FIG. 9).

[0057] Regarding the procedure for putting on the respiratory mask and the operation of the respiratory mask equipment, only the inflation and deflation operations of the gas-enclosing molded portion (31), which are different from those in the first embodiment, will be described with reference to Figs.

[0058] By operating the pressure control device (51), it is possible to set whether the nose bridge portion or the chin portion, or both, are expanded when the gas surrounding molding portion (31) is expanded.

[0059] For example, when only the bridge of the nose is expanded, it is deformed as shown in FIG. 10, and when only the chin is expanded, it is deformed as shown in FIG. 11 (FIGS. 10 and 11).

[0060] The expansion and deformation of the gas-encircling molded portion indirectly increases the pressure at the face-contact portion, causing the strap (40) to stretch, as in the first embodiment. EXAMPLES

[0061] The breathing mask of the third embodiment differs from the first and second embodiments in the shape of the gas-enclosing molded portion, and only the different parts will be described with reference to FIG.

[0062] The respiratory mask (1) is composed of a face contact part, a mask support and a strap similar to those of the respiratory mask of Example 1, and a predetermined outer dimension deformable body (30) whose outer dimensions are deformed and sandwiched between the face contact part and the mask support. The outer dimension deformable body is composed of four gas-enclosing molded parts (31) (only three visible from the outside are drawn in Figure 7) that have the function of sealing and maintaining gas therein, and a gas inlet / outlet (32) arranged on each of the gas-enclosing molded parts (Figure 12).

[0063] Regarding the gas-encircling molding section (31), the gas-encircling molding section of the first embodiment is divided into four independent sections (FIG. 12).

[0064] The number of the gas inlet / outlet ports (32) is one on each of the gas surrounding moldings (31) (FIG. 12). [Industrial Applicability]

[0065] INDUSTRIAL APPLICABILITY The present invention provides an excellent respiratory mask and respiratory mask equipment that enables proper wearing of the respiratory mask and reduces stress and discomfort caused by changes in the wearing condition of the respiratory mask after wearing, and therefore has industrial applicability. [Explanation of symbols]

[0066] 1. Respiratory mask 2. Respiratory mask equipment 10 Face contact area 20 Mask Support 21 Mask support part 22 Inhalation and expiratory tube connection port 30 External dimensions changeable body 31 Gas-enclosing molding section 32 Gas inlet / outlet (connection port to pressure regulation control means) 40 Straps 50 Pressure regulation control means 51 Pressure control equipment capable of continuous pressure control 52 Devices that allow temporary pressure adjustment 60 Pressure regulation control tube 61 Tube extension unit 70 Inhalation and Exhalation Tube 80 Pressure regulation control means or remote controls for pressure control devices

Claims

1. A respiratory mask for use in the treatment of sleep apnea syndrome, non-invasive positive pressure ventilation therapy, etc. A face contact part (10) which is a part that comes into contact with a person's face when wearing the mask; A mask support (20) to be placed at a position above the face contact portion and away from the face; The mask support includes at least a predetermined outer dimension deformable body (30) whose outer dimension is deformed and which is sandwiched between the face contact portion and the mask support, The outer dimension deformable body is composed of one or more gas-enclosing molding parts (31) having a function of sealing and maintaining gas inside, and a gas inlet / outlet (32) disposed on the gas-enclosing molding parts, The gas-enclosing molded portion has an outer dimension that expands and becomes larger when gas is introduced into the internal space, and has an outer dimension that contracts and becomes smaller when gas is released from the internal space.

2. 2. The respiratory mask of claim 1, wherein the gas-enclosing molded portion (31) expands in outer dimensions by introducing gas into its internal space, thereby pulling the mask belt.

3. 2. The breathing mask of claim 1, wherein only one gas inlet / outlet (32) is provided on the outer dimensionally deformable body.

4. 3. The breathing mask according to claim 2, wherein only one gas inlet / outlet (32) is provided on the outer dimensionally deformable body.

5. A respiratory mask equipment further comprising a pressure adjustment control means (50) for temporarily or continuously adjusting or controlling the pressure in the internal space of the gas-enclosing molded portion by introducing or releasing gas into or from the gas inlet / outlet constituting the respiratory mask of any one of claims 1 to 4, a pressure adjustment control tube (60) connecting the pressure adjustment control means and the gas inlet / outlet, and an inhalation / exhalation tube (70) inserted into the mask support constituting the respiratory mask of any one of claims 1 to 4.

6. 6. The respiratory mask equipment according to claim 5, wherein the pressure regulation control means (50) is a pressure control device (51) capable of continuously controlling the pressure in the internal space of the gas-enclosing molded portion.

7. 7. The respiratory mask equipment according to claim 6, further comprising a remote controller for operating said pressure control device (51).

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