JP2008073550A - Respiration mask having gas exhaust ventilation hole and gas exhaust ventilation hole assembly for respiration mask - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an exhaust ventilation hole assembly suitable for joint use with a respiration mask for use in CPAP treatment. <P>SOLUTION: In one embodiment, the ventilation hole is made of a thin air-permeable membrane. Generally the membrane is thinner than 0.5 mm. The membrane can be made of hydrophobic material such as polytetrafluoroethylene (PTFE). The membrane can be also made of drawn PTFE. The drawn PTFE membrane is fitted to a polypropylene scrim. The standard aperture size of the aperture of the membrane is 10 to 15 μm. In an alternative embodiment, the ventilation hole assembly includes a ventilation hole formed of stainless steel. In another embodiment, the sectional area of the membrane is about 500 mm<SP>2</SP>. In another embodiment, the ventilation hole assembly includes a membrane fitted to a ventilation hole frame, and the ventilation hole assembly forms an insert for removably fitting a mask frame. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a respiratory mask and a gas exhaust vent for the respiratory mask.

Continuous positive pressure breathing (CPAP) through a nasal mask improves sleep disordered breathing (SDB), including obstructive sleep apnea (OSA), as described in Applicant's US Pat. No. 4,944,310. It is generally applied to treatment. In CPAP treatment for OSA, air or other breathable gas is higher than atmospheric pressure, typically supplied to the airway inlet of the patient 3~20cmH ₂ O was measured with a contact portion with the patient Is done. It is also known to change the level of treatment pressure during the treatment period as needed by the patient, and that form of CPAP automatically performs the nasal CPAP treatment described in Applicants' US Pat. No. 5,245,995. Known to adjust.

  Non-invasive positive pressure ventilation (NIPPV) is another form of treatment for respiratory disorders, including sleep disordered breathing. In its basic form, NIPPV is where a relatively high pressure gas is sent to the patient contact during the breathing inspiratory phase and a relatively low pressure or atmospheric pressure is applied to the patient contact during the breathing exhalation phase. Including being sent. In other NIPPV forms, the pressure can be varied in a complex manner throughout the respiratory cycle. For example, as disclosed in Applicant's International PCT Patent Application No. WO 98/12965 and International PCT Patent Application No. WO 99/61088, pressure at the point of contact with the patient during inspiration or expiration is maintained throughout the treatment period. Can be changed.

  In this specification, reference to CPAP treatment should be understood to encompass all of the aforementioned forms of ventilation treatment or assistance.

Typically, the patient contact area for CPAP treatment consists of a nasal mask. A nasal mask is generally defined by a mask shell that forms an internal cavity defined by its inner surface, mask cushion, and user's face, and a gas inlet that may or may not include a separate part such as a swivel elbow. The Alternatively, nose mouth masks, full face masks, nasal prongs, or nasal pillows can be used. In this specification, unless otherwise indicated, reference to a mask should be understood to incorporate reference to a nasal mask, nose mouth mask, full face mask, nasal prong, or nasal pillow. The mask incorporates or has a gas exhaust vent for adjoining the discharged gas into the atmosphere. A gas exhaust vent (vent) may be referred to as a CO ₂ exhaust vent.

  It is important that the device be quiet and comfortable to encourage the patient to follow treatment. Noise is generated by discharging the discharged gas into the atmosphere through the vent hole. Since CPAP and NIPPV treatments are usually performed during patient sleep, it is desirable to minimize such noise in consideration of both patient comfort and patients in the same room.

From a clinical point of view, in the combination of a mask and a vent, it is desirable to remove the discharged CO ₂ through the vent as much as possible and to inhale the supplied breathable gas as much as possible. In this way, the residual amount of discharged CO ₂ in the mask that the wearer “sucks again” is minimized. In general, by disposing a vent hole in the mask shell, the CO ₂ emission is superior to the case where a similar vent hole is disposed between the mask shell and the breathable gas supply conduit. Become.

  It is desirable to minimize the weight of the vent assembly for greater patient comfort.

  Systems for performing nasal CPAP treatment often incorporate an in-line humidifier to minimize nasal mucosal drying and increase patient comfort. Therefore, it is desirable that the vent is not blocked when used with humidified gas. In addition, it is desirable that the vent hole can be easily cleaned and can be disposed economically.

  Several vent hole formations are known. One approach to forming the vent is to make one or more openings in the mask shell that allow exhaust gases to flow from the internal cavity into the atmosphere. The exhaust stream may be directed by incorporating additional tubes extending outwardly from openings located on the outer surface of the mask shell.

  Applicant's nasal mask system, known under the name ResMed Modular Mask System, incorporates an outlet vent located in a swivel elbow connected to a mask shell. The ports defining the vents have the same cross-sectional thickness and are formed from the same polycarbonate material used to form the swivel elbow and mask shell frame.

  A whisper swivel manufactured by Respironics, Inc. has three elongated holes around a generally cylindrical mounting component. In use, the mounting part is placed between the mask shell and the gas conduit. The mounting parts are made of the same material and thickness as those used to manufacture the mask shell.

  EP 679225 discloses a vent formed from a porous sintered material.

  Gottleib Weinmann Gerate Fur Medizin Un Arbeitschutz GmbH and Co. The known vents manufactured by the US have a generally cylindrical insert that is placed between the mask shell and the gas conduit in use. The insert includes a window covered with a porous sintered material about 3-4 mm thick.

  Another type of vent inserted between the mask shell and the breathable gas supply conduit is E-Vent N (Draeger vent) manufactured by Draeger medtechntech GmbH. The Draeger vent comprises 21 stacked annular disks, which have elongated holes on adjacent faces so that gas can flow through them. Each oblong hole has a length of 5-7 mm as measured along the passage from the interior of the vent hole to the atmosphere.

Applicants have produced respiratory masks known as the MIRAGE® nasal mask system and MIRAGE® full-face mask (MIRAGE mask). The MIRAGE (R) mask has a crescent-shaped opening in the mask shell, in which a complementary crescent-shaped elastomer insert with six holes forming vents is located. The cross-sectional thickness of the elastomer insert is 3-4 mm. Vents of the type used in MIRAGE® are described in International Patent Application No. WO 98/34665 and Australian Patent No. 712236.
US Pat. No. 5,245,995 International PCT Patent Application No. WO 98/12965 International PCT Patent Application No. WO99 / 61088 International Patent Application No. WO 98/34665 Australian Patent No. 712236

  It is an object of the present invention to provide an alternative form of vent suitable for use with a respiratory mask.

  The present invention provides a vent assembly suitable for use with a mask used in CPAP treatment, wherein the vent assembly is a thin air permeable membrane.

  In one form of the invention, the membrane is thinner than the mask frame.

  In another form of the invention, the membrane is thinner than 0.5 mm.

  In another form of the invention, the membrane is about 0.05 mm thick.

  In another form of the invention, the membrane is comprised of a hydrophobic material such as polytetrafluoroethylene (PTFE).

  In another form of the invention, the membrane is composed of stretched PTFE.

  In another form of the invention, a stretched PTFE membrane is attached to a polypropylene scrim.

  In another form of the invention, the standard pore size of the membrane pores is 10-15 microns.

  In another form of the invention, the membrane is comprised of stainless steel.

In another form of the invention, the cross-sectional area of the vent membrane is about 500 mm ² .

  In another form of the invention, the vent assembly comprises a membrane attached to the vent frame, and the vent assembly forms an insert that can be removably attached to the mask frame.

  In another form of the invention, a respiratory mask is provided for communicating breathable gas to the wearer's airway inlet, the mask including (i) a mask shell, (ii) a gas inlet, and (iii) an opening. In this opening, an insert made of a thin air-permeable membrane having a corresponding shape can be arranged. The opening may be located in the mask shell or gas inlet.

  In one form, the mask includes a mask shell with an integrally formed gas inlet, and an opening is provided in the mask shell remote from the inlet. In another form, the mask includes a mask shell having an integrally formed gas inlet, and an opening is provided in the gas inlet. In yet another form, the mask includes a mask shell fitted with a separately formed gas inlet, and an opening is provided in the mask shell remote from the inlet. In yet another form, the mask includes a mask shell fitted with a separately formed gas inlet, and an opening is provided in the gas inlet.

  The present invention also provides a breathing mask configuration that allows breathable gas to communicate with the wearer's airway inlet, which includes a vent assembly with an opening through which a thin air permeable membrane extends across the opening.

  The present invention also provides an apparatus for performing CPAP, the apparatus including a mask configuration that allows breathable gas to communicate with the wearer's airway inlet, wherein the mask configuration extends a thin air permeable membrane over the opening. A gas exhaust vent assembly with an opening is included.

  FIG. 1 shows a nasal respiratory mask 10 according to a first embodiment of the present invention. Mask 10 includes a rigid plastic mask shell 12 having a peripheral flange 14 for attaching a cushion (not shown) to mask shell 12. The cushion abuts the wearer's face when in use and is well known in the art. The flange 14 includes a slot 15 for connecting a mask restraining strap (not shown) that extends around the wearer's head and holds the mask 10 adjacent to the wearer's face. This strap is also known in the art. The mask shell 12 also includes an arm 16 that terminates in a fitting 18 adapted to connect to a forehead support (not shown) known in the art.

  The mask shell 12 includes a breathable gas inlet 20 that is rotatably attached to the mask shell 12. The gas inlet 20 is connected to a first end 22 configured to connect to a breathable gas supply conduit (not shown) and to the interior of the mask shell 12 to supply the supplied gas to the mask shell 12. A second end 24 adapted to communicate with the interior and subsequently communicate with the wearer's airway.

  The mask 10 includes a gas exhaust vent defined by an opening 26 in the mask shell 12 through which a thin air permeable membrane 28 extends.

In the embodiment of FIG. 1, the thin air permeable membrane 28 is a stainless steel sheet of about 0.45 mm with holes about 0.1 mm in diameter. The total open area is about 5% of the total surface area of the sheet. The sheet size is about 322 mm ² . The holes are laser cut into stainless steel. The holes are preferably laser cut or frame cut through stainless steel.

  The hole diameter is preferably less than 0.2 mm and the total open area is preferably about 1% to 25% of the surface area of the steel. The hole may taper through its lumen (gradually or stepped). In use, placing the smaller end of the vent opening on the atmosphere side minimizes the possibility of blockage caused by the insertion of particulate material. Or you may arrange | position the edge part with the larger opening of a ventilation hole in the atmosphere side, and make a ventilation hole more quiet.

  FIG. 2 shows a nasal respiratory mask 40 according to a second embodiment of the present invention. Similar features are used with respect to the second embodiment, using the same reference numerals used to describe the first embodiment. Accordingly, the mask 40 has a mask shell 12 with a gas inlet 20. Instead of the slot 15 of the first embodiment, the mask shell is an opening adapted to snap-engage with a fitting (not shown) provided at the end of a mask restraining strap (not shown). 42 is included. Further, instead of the arm 16 and the metal fitting 18, the mask 40 includes an adjustable forehead support mechanism generally designated by reference numeral 44.

  The mask 40 also includes a vent formed by an opening 26 formed in the gas inlet 20 through which a thin air permeable membrane 28 extends.

  FIG. 3 shows a mask 60 according to a third embodiment of the present invention. While this embodiment is directed to a nasal mask, it should be noted that various vent configurations can be used with various mask configurations. Again, similar features are indicated with respect to the third embodiment, using the same reference numerals used to describe the features of the first embodiment. The mask 60 includes a mask shell 12 having a fixed gas inlet 62 integrally formed. A cushion 64 is attached to the peripheral flange 14 of the mask shell 12. The mask shell 12 also includes a perforated extension 66 for connecting a headgear (not shown) to the mask. The mask 60 includes an opening 26 over which extends a thin air permeable membrane 28 that is identical in construction to the ePFTE membrane described below in connection with the mask 40 shown in FIG.

  FIG. 4 shows a cross-sectional view of the vent assembly 110. A membrane 114 is provided between the outer element 112 and the inner element 116. This configuration is for a single assembly. There are corresponding openings 115 in the outer element 112 and the inner element 116 to allow air to pass through the membrane. The inner element 116 may form part of a mask frame or a separate insert that is disposed within the opening of the mask frame.

  FIG. 5 is another cross-sectional view of the vent assembly 110. A stainless steel membrane insert 118 is disposed on the inner element 120. There is an opening 119 in the inner element 120 to allow air to pass through the membrane. The internal element 120 may form part of a mask frame or a separate insert that is disposed within the opening of the mask frame.

FIG. 6 shows a nasal respiratory mask 80 according to a sixth embodiment of the present invention. Mask 80 is similar to the second embodiment of mask 40 shown in FIG. 2, and like reference numerals are used to indicate similar features with respect to the second embodiment. In the mask 40 of FIG. 2, vents are provided in the gas inlet 20, whereas in the mask 80, vents are provided in the mask shell 12. More particularly, the mask 80 includes two cylindrical inserts 82 that have an internal opening 26 through which a thin air permeable membrane 28 extends. The thin air permeable membrane is made from a GORE-TEX® product attached to a polypropylene scrim having an area of 481 mm ² . The membrane is composed of stretched polytetrafluoroethylene (ePTFE). The inventors have worked in W.M., Maryland, USA. L. Gore & Associates, Inc. GORE-TEX (R) ePTFE product (GORE-TEX (R) membrane) manufactured by the company is recognized as a suitable material for constructing the membrane. In one preferred form, the GORE-TEX® membrane has the following properties:
Membrane material 100% stretched polytetrafluoroethylene Standard pore size 10-15 microns Bubble points Typically 0.02 bar each minimum Airflow 0.37 LPM / cm ²
Thickness 0.05mm
Base Polypropylene Scrim

  FIG. 7 shows a seventh embodiment of a full breathing mask 100 according to the present invention. Again, similar features are used with respect to this embodiment, using the same reference numerals as used to indicate similar features as in the previous embodiment. The mask 100 is similar to the mask 80 shown in FIG. 6 in that vents are provided in the insert 82. However, mask 100 uses a perforated extension 66 instead of opening 42 to attach a mask restraint strap (not shown).

  As best seen in FIG. 8, which is an enlarged view of the insert shown in FIG. 6, the insert 82 includes a cylindrical portion 86 sized to fit snugly within a circular orifice 88 provided in the mask shell 12. ing. The insert 82 is disposed against the outer surface of the mask shell 12 by a peripheral flange 90. The insert may be glued in place.

  FIG. 9 shows a further embodiment of the present invention with a series vent assembly. Similar reference numbers are used to indicate similar features to the previous embodiments. In this embodiment, the in-line vent assembly comprises a generally cylindrical vent frame having a “window” or “port” covered with the membrane described above.

  The thin air permeable membrane of the present invention may be attached to the mask by any suitable means. For example, the stainless steel vents described above may be attached to a polycarbonate mask shell by (for example) thermal bonding or other suitable bonding. The durability to be achieved will determine the appropriate attachment technique.

  In further embodiments, means are provided to indicate the amount of air that has passed through the vent or the time that the vent assembly has been used. When a sufficient amount of air has passed through the vent assembly or when the assembly has been used for a sufficient amount of time and closed, the indicator signals that the vent assembly should be replaced.

  For convenience, as shown in FIG. 8, a thin air permeable membrane can be provided in the insert that can be releasably attached to the mask shell via a press-fit mechanism. Preferably, at least one cross member is provided on at least the outer surface of the insert to protect the air permeable membrane from damage when the air permeable membrane is placed in the receiving orifice of the mask shell. This approach allows the vent insert to be easily placed, removed and replaced while holding other parts of the mask. The insert may be configured to take any required shape, but the insert has a circular perimeter shape that defines a cylindrical insert that friction fits within the corresponding circular orifice of the mask shell or gas inlet It is preferable.

Forming the vent through the use of the insert configuration facilitates selection and mounting of the vent that meets the user's requirements. For example, when a low treatment pressure is required, the associated flow is relatively small compared to the flow required to achieve a higher treatment pressure. Under such circumstances, a relatively large vent area may be employed to facilitate achieving a clinically desirable mask CO ₂ emission rate. If higher therapeutic pressure is required, the preselected vent may be replaced with a vent that is more restrictive to flow. More restrictive vents achieve clinically desirable mask CO ₂ emission rates while avoiding noise intensity and exhaust gas injection that occurs when preselected low pressure vents are used at high therapeutic pressures be able to.

By disposing the vent hole in the mask shell, it is possible to minimize the CO ₂ residue in the mask as compared with disposing the vent hole as a serial mask part.

  Although the invention has been described with reference to specific examples, it is to be understood that these examples are merely illustrative of the application of the principles of the invention. Accordingly, it should be understood that numerous modifications can be made in the illustrated example of the invention, and that other configurations can be devised without departing from the spirit and scope of the invention.

1 is a perspective view of a respiratory mask according to a first embodiment of the present invention. It is a perspective view of the respiratory mask by the 2nd Embodiment of this invention. It is a perspective view of the respiratory mask by the 3rd Embodiment of this invention. 6 is a partial cross-sectional view of a vent assembly according to a fourth embodiment of the present invention. FIG. FIG. 7 is a partial cross-sectional view of a vent assembly according to a fifth embodiment of the present invention. It is a perspective view of the respiratory mask by the 6th Embodiment of this invention. It is a perspective view of the whole surface mask by the 7th Embodiment of this invention. FIG. 8 is an enlarged detail view of an insert suitable for use with the mask shown in FIGS. 6 and 7. FIG. 10 is a perspective view of a vent assembly according to an eighth embodiment of the present invention, with a thin air permeable membrane disposed in a cylindrical position of the tube suitable for attachment to a mask elbow.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Mask 12 Mask shell 14 Flange 15 Long hole 16 Arm 18 Metal fitting 20 Gas inlet 26 Opening 28 Thin air permeable film

Claims (36)

In contact with the patient communicating with the patient's airway in use;
A gas inlet for providing a range of 3~20cmH _{2 O} pressurized breathable gas to the contact portion between the patient,
A gas exhaust ventilation portion having a plurality of holes having a diameter for exhausting sufficient CO ₂ from the contact portion with the patient at the lowest pressure range;
The plurality of holes are arranged in a plurality of rows, each row having at least three of the holes;
A breathing mask, wherein each of the holes has a first end located on the inner surface of the mask and a second end located on the outer surface of the mask, and the diameter of the first end is smaller than the diameter of the second end.   The respiratory mask according to claim 1, wherein the contact portion with the patient has a nasal cushion and a gas exhaust ventilation portion is provided at the gas inlet.   The respiratory mask of claim 1, wherein the patient contact portion has a pillow cushion on a nasal prong or shell, and a gas exhaust vent is provided at the shell or gas inlet.   The respirator according to claim 1, wherein the contact portion with the patient includes a cushion of a full-face cushion type and a shell provided with a cushion, and the gas exhaust ventilation portion is provided in the shell.   The respiratory mask of claim 1, wherein the plurality of holes comprises at least 20 holes.   The respiratory mask of claim 1, wherein the plurality of holes comprises at least 30 holes.   The respiratory mask of claim 1, wherein each of the holes has a tapered cross section. The contact area with the patient,
A breathable gas inlet for providing pressurized gas when the mask is in use;
A gas exhaust vent including an air permeable portion for exhausting gas from the patient contact portion, the portion having at least 10 through holes, each having a length, diameter, and sufficient for the patient to breathe Has a total open area with holes that eliminate or reduce noise while maintaining good CO ₂ emissions,
A breathing mask, wherein each of the holes has a first end located on the inner surface of the mask and a second end located on the outer surface of the mask, and the diameter of the first end is smaller than the diameter of the second end.   The respiratory mask of claim 8, wherein the total open area is approximately 5% or more.   The respiratory mask according to claim 8, wherein the total open area is 25% or less.   The respiratory mask according to claim 8, wherein the contact portion with the patient has a nasal cushion or a full cushion.   9. A respiratory mask according to claim 8, wherein the patient contact portion comprises a nasal prong or pillow. Cushion,
A breathable gas inlet for providing pressurized gas to the patient through the cushion when a mask is in use;
At least one gas exhaust vent for exhausting gas from the mask, wherein the exhaust vent has at least 20 through holes, each eliminating noise while maintaining sufficient CO ₂ emissions during patient breathing or Having reduced length and diameter,
A respiratory mask, wherein each of the holes has a first end located on the inner surface of the mask and a second end located on the outer surface of the mask, wherein the diameter of the first end is larger than the diameter of the second end. The respiratory mask of claim 10, wherein the thickness of the membrane is about 0.05 mm.   The respiratory mask of claim 13, wherein each of the holes has a length of about 0.5 mm.   14. A respiratory mask according to claim 13, wherein the cushion comprises a nasal cushion or a full cushion.   The respiratory mask according to claim 13, wherein the cushion is used.   14. A respiratory mask according to claim 13, wherein there are at least 30 through holes and the gas exhaust vent has two vent portions. A contact portion with a patient having a frame portion and a nasal prong or pillow type nasal contact portion, wherein the frame portion and the nasal contact portion together form a respiratory chamber;
A breathable gas inlet for providing pressurized gas to the patient contact area when a mask is being used;
A respiratory mask, comprising at least 20 through holes for gently discharging gas from the respiratory chamber, wherein the holes are arranged in a plurality of rows.   The respiratory mask of claim 18, wherein the plurality of rows are at least four rows, each having at least three of the holes.   20. A respiratory mask according to claim 19, wherein the plurality of rows are at least 5 rows, each having at least 3 of the holes. A CPAP apparatus comprising: a blower that generates a pressurized gas in a range of 3 to ₂₀ cmH ₂ O; and the mask according to claim 18.   19. A respiratory mask according to claim 18, comprising an adjustable front support at the contact portion with the patient.   The respiratory mask according to claim 18, wherein the ventilation portion is provided in the frame portion.   The respiratory mask of claim 18, wherein the vent portion is provided at the gas inlet.   The hole is provided and extends through the gas inlet, and the hole is tapered so that the inner diameter of each hole toward the inner surface of the gas inlet is smaller than the outer diameter of the outer surface of the gas inlet. The described respiratory mask.   Each of the holes has a first end located toward the breathing chamber and a second end located away from the breathing chamber, the diameter of the first end being smaller than the diameter of the second end; The respiratory mask according to claim 18.   19. The respiratory mask of claim 18, wherein the patient contact portion has a frame portion that supports the cushion, the cushion taking the form of a nasal prong or pillow.   19. A respiratory mask according to claim 18, wherein the patient contact portion includes a shell that supports the cushion, the cushion taking the form of a nasal cushion or a full cushion. A contact portion with a patient having a cushion;
A breathable gas inlet for providing pressurized gas to a breathing chamber that is at least partially formed by contact with the patient when a mask is in use;
A gas exhaust vent having a plurality of holes having a diameter and shape selected to gently vent gas from the breathing chamber;
The vent has a thickness of 3 mm or less,
The respiratory mask, wherein the ventilation portion includes at least 20 holes, and the holes are arranged in a plurality of rows.   30. The respiratory mask of claim 29, wherein the plurality of rows are at least four rows, each having at least three of the holes.   31. A respiratory mask according to claim 30, wherein the plurality of rows are at least 6 rows, each having at least 3 of the holes.   32. A respiratory mask according to claim 31, wherein the plurality of rows are at least 8 rows, each having at least three of the holes. A shell in communication with the patient's airway in use, the shell including a separately formed gas inlet for supplying pressurized breathable gas in the range of 3-20 cm;
Forming a cushion provided in the shell, and a breathing chamber in which the cushion and the shell are pressurized;
A gas exhaust vent portion having a plurality of through holes having a diameter for exhausting sufficient CO ₂ from the contact portion with the patient at the lowest pressure range, wherein the gas exhaust vent has at least one opening. An air permeable material disposed between the element and an outer element having at least one opening, wherein CO ₂ gas discharge from the breathing chamber is one of the inner element, the air permeable material and the outer element. A respiratory mask, characterized by being directed through at least one opening.   34. A respiratory mask according to claim 33, wherein the inner element is formed as part of the shell.   34. A respiratory mask according to claim 33, wherein the inner element and the outer element are mechanically coupled to each other.   36. A respiratory mask according to claim 35, wherein the vent portion is provided towards the gas inlet.

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