Source: https://patents.google.com/patent/JP2012011243A/en
Timestamp: 2020-01-22 00:37:24
Document Index: 147706636

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'Application No. 60', 'art 40', 'art 812', 'art 812', 'art 102', 'art 120', 'art 146', 'art 230', 'art 300', 'art 800', 'art 810', 'art 822', 'art.\n19']

JP2012011243A - Vent system for continuous positive airway pressure patient interface used in treatment of sleep disordered breathing - Google Patents
Vent system for continuous positive airway pressure patient interface used in treatment of sleep disordered breathing Download PDF
JP2012011243A
JP2012011243A JP2011228725A JP2011228725A JP2012011243A JP 2012011243 A JP2012011243 A JP 2012011243A JP 2011228725 A JP2011228725 A JP 2011228725A JP 2011228725 A JP2011228725 A JP 2011228725A JP 2012011243 A JP2012011243 A JP 2012011243A
JP2011228725A
パトリック・ジョン・マコーリフィ
2011-10-18 Application filed by Resmed Ltd, レスメド・リミテッドＲｅｓｍｅｄ Ｌｔｄ filed Critical Resmed Ltd
2012-01-19 Publication of JP2012011243A publication Critical patent/JP2012011243A/en
PROBLEM TO BE SOLVED: To solve such problems with conventional art vents that they can be too noisy, that they clog with dirt and moisture (particularly when used with humidifiers), that they are awkward or difficult to clean or assemble, and that they have designs which are sensitive to very small changes in the manufacturing process which can lead to variation in the pressure flow relationship.SOLUTION: A vent assembly for use with a mask assembly includes a first vent, a second vent, and a selector to switch the flow of exhaled gas from a patient between the first and second vents.
The present invention relates to a continuous positive airway pressure (CPAP) patient interface used for the treatment of Sleep Disordered Breathing, such as an exhaust system for use with a mask.
(Cross-reference of priority application)
This application includes US Provisional Application No. 60 / 524,728 filed on Nov. 25, 2003, US Provisional Application No. 60/538507, filed Jan. 26, 2004, and March 8, 2004. Claims priority to US Provisional Patent Application No. 60 / 550,319, which is hereby incorporated by reference in its entirety.
The use of a nasal CPAP device to treat “snoring sickness” was taught by US Pat. Nasal CPAP devices typically comprise a blower, an air supply conduit, and a patient interface. This blower provides a gas suitable for air or breathing at positive pressure. The conduit interconnects the blower and the patient interface. A variety of nasal masks, nasal and mouth masks, full face masks, nasal prongs and nasal pillows are used to provide patient interface.
A typical mask is
(I) a rigid or semi-rigid portion called shell or frame that defines a cavity for receiving the nose;
(Ii) a flexible patient contact portion called a cushion or membrane. Cushions have been formed from silicone, foam, gel, and combinations of these materials.
Because patients typically exhale into the same mask cavity from which they inhale, there is the possibility of rebreathing carbon dioxide (CO 2 ). In parallel with a sufficient continuous flow of fresh air or gas suitable for breathing, the exhaust allows for controlled leakage from the mask cavity, thus providing a CO 2 flush. Unfortunately, the noise of air from the exhaust or gas suitable for breathing can prevent people who are audible from trying to sleep. Therefore, there is an advantage in providing a low noise exhaust.
One known exhaust section is described in Patent Document 2 and Patent Document 3. These patents describe the use of grommets in the mask frame. The contents of these patents are hereby incorporated by cross-reference. The exhaust according to embodiments of these inventions can be found in a MIRAGE ™ mask manufactured by ResMed Limited.
Another known form of exhaust is described in US Pat. This patent application describes the use of a connector for a mask having an exhaust along a smooth continuous surface. The contents of this patent application are hereby incorporated by cross-reference. The exhaust according to one embodiment of the present invention is found in an ULTRA MIRAGE ™ mask manufactured by ResMed Limited.
Another known form of exhaust is described in US Pat. This patent, in one form, describes the use of an exhaust with a thin air permeable membrane. The contents of this patent application are hereby incorporated by cross-reference.
Another known form of exhaust is described in US Pat. This patent application describes the use of a flow control exhaust. The contents of this patent application are hereby incorporated by cross-reference.
Patent Document 7 describes an exhaust valve device. The contents of this patent application are hereby incorporated by cross-reference.
Another known exhaust is the Respironics WHISPER swivel.
Patent document 8 discloses the exhaust part formed from a porous sintered material.
A known exhaust manufactured by Gottleib weinmann Gerate Fur Medizin Und Arbeitsschutz GmbH and Co. comprises a generally cylindrical insert which, in use, is placed between the mask shell and the gas conduit. The insert comprises a window covered with a porous sintered material having a thickness of about 3-4 mm.
Another type of exhaust intended to be inserted between the mask shell and the breathable gas supply conduit is the E-Vent N (Draeger vent) by Draeger medizintechnik GmbH. This Draeger vent comprises a stack of 21 annular discs with slots on their adjacent surfaces through which gas flows. Each slot has a length of 5 to 7 mm measured along the path from the inside of the exhaust to the atmosphere.
The exhaust is typically designed with sufficient porosity to provide sufficient exhaust flow at low pressure (eg, 4 cm H 2 O) to ensure proper CO 2 flushing.
Reducing the hole size of the exhaust part makes exhaust more quiet, but can also increase the chance of the exhaust part becoming blocked.
The problems with the prior art exhausts are that they are too noisy, clogged with dirt and moisture (especially when used with a humidifier), cumbersome or difficult to clean and assemble, Is sensitive to small changes, which can lead to changes in the relationship between pressure and flow.
US Pat. No. 4,944,310 US Pat. No. 6,561,190 US Pat. No. 6,561,191 International Publication No. WO00 / 078381 Pamphlet US Pat. No. 6,581,594 International Publication No. WO02 / 051486 Pamphlet US Pat. No. 6,555,555 European Patent No. 0679225 International Publication No. WO04 / 022147 Pamphlet International Publication No. WO02 / 066105 Pamphlet
According to a first aspect of the present invention, an exhaust for a CPAP patient interface is provided.
According to a second aspect of the present invention, there is provided an exhaust assembly comprising at least two alternative exhaust units each having substantially the same pressure and flow characteristics.
According to a third aspect of the present invention, there is provided an exhaust assembly comprising at least two alternative exhaust units each having different pressure and flow characteristics.
In accordance with another aspect of the present invention, there is provided an exhaust assembly comprising at least two alternative exhausts and an attachment adapted to support at least one exhaust in an exhaust position.
According to another aspect of the present invention, at least two alternative exhaust parts, an attachment part adapted to support at least one exhaust part at the exhaust position, and the at least one exhaust part are held at the exhaust position. And an exhaust assembly including the fixing mechanism.
According to still another aspect of the present invention, the frame, the cushion provided in the frame, and the flow of the gas discharged from the first exhaust unit, the second exhaust unit, and the patient, A patient mask assembly is provided that includes an exhaust assembly with a switch for switching between exhaust sections.
1 is a schematic diagram of a prior art blower, air supply conduit and patient interface. FIG. 1 is a view of a related art mask having a swivel elbow. FIG. 1 is a cross-sectional view of a related art patient interface in position on a patient's face with a pivoting elbow. FIG. It is the side view, sectional drawing, and detail drawing of a turning part by the 1st Embodiment of this invention. It is the side view, sectional drawing, and detail drawing of a turning part by the 1st Embodiment of this invention. It is the side view, sectional drawing, and detail drawing of a turning part by the 1st Embodiment of this invention. It is a figure which exists in three positions of the turning part by the 1st Embodiment of this invention. It is a figure which exists in three positions of the turning part by the 1st Embodiment of this invention. It is a figure which exists in three positions of the turning part by the 1st Embodiment of this invention. It is a disassembled perspective view of the turning-type elbow by the 2nd Embodiment of this invention. FIG. 6 is a view of a swivel elbow assembly according to a second embodiment of the present invention with an exhaust in a “coarse” hole position. FIG. 6 is a view of the swivel elbow assembly according to the second embodiment of the present invention with the exhaust in the “fine” hole position. It is a figure of the turning-type elbow sleeve by the 2nd Embodiment of this invention. FIG. 6 is a view of a pivoting elbow assembly according to another embodiment of the present invention suitable for use with a RESMED ULTRA MIRAGE mask. 1 is a view of a sliding exhaust assembly according to an embodiment of the present invention. 1 is a view of a sliding exhaust assembly according to an embodiment of the present invention. FIG. 11b is another view of the exhaust assembly of FIG. 11a. FIG. 11b is a drawing of the exhaust assembly of FIG. 11a. FIG. 11b is an alternative view of the exhaust assembly of FIG. 11a. 1 is a front view of a swivel elbow having an exhaust assembly according to a first embodiment of the present invention. FIG. 1 is a side view of a swivel elbow having an exhaust assembly according to a first embodiment of the present invention. 1 is a front view of an assembly including a swivel elbow having a mask frame and an exhaust assembly according to the first embodiment of the present invention; FIG. FIG. 18 is a side view of the assembly of FIG. 17. FIG. 18 is a perspective view of the assembly of FIG. 17. FIG. 3 is a diagram of one embodiment of the present invention incorporating visual, tactile and auditory feedback of exhaust location. 1 is a diagram of one embodiment of the present invention incorporating an electrical resistance sensor. FIG. FIG. 6 is an illustration of an embodiment of the present invention having a slidable exhaust cover that exposes a set of larger holes. FIG. 6 is an illustration of an embodiment of the present invention having a slidable exhaust cover that exposes a set of smaller holes. It is a figure of another embodiment of this invention. It is a figure of another embodiment of this invention. It is a figure of another embodiment of this invention. 1 is a view of an embodiment of the present invention having an exhaust cover connected by a hinge. FIG. FIG. 7 is an alternative embodiment of the present invention incorporating a rotating exhaust cover. FIG. 7 is an alternative embodiment of the present invention incorporating a rotating exhaust cover. FIG. 6 is a diagram of another alternative embodiment of the present invention. FIG. 6 is a diagram of another alternative embodiment of the present invention. FIG. 6 is a diagram of another alternative embodiment of the present invention. It is a figure of another embodiment of this invention. It is a figure of another embodiment of this invention. It is an exploded view of the cartridge type embodiment of the present invention. FIG. 2 is a view at two different positions of a cartridge type embodiment of the present invention. FIG. 2 is a view at two different positions of a cartridge type embodiment of the present invention. It is a figure of another embodiment of this invention. It is a figure of another embodiment of this invention.
FIG. 1 shows a blower 10 connected to an air supply conduit 20 and an air supply conduit 20 connected to a patient interface 30. In FIG. 1, the patient interface 30 is a nasal mask. The patient interface 30 includes an exhaust 40. The exhaust part 40 includes one or more holes, for example, six holes 50.
FIG. 2 is an alternative nasal mask MIRAGE® ACTIVA ™ nasal mask. The mask includes a swivel elbow 60. This swivel elbow is described in more detail in US Pat. No. 6,057,097, the contents of which are incorporated herein by cross reference. The swivel elbow 60 includes an exhaust cover 70 having a number of holes 50 therethrough.
FIG. 3 shows a cross section of the patient interface 30 in place on the patient 80 face. The pivoting elbow 60 is removed and shown in front of the patient interface 30. The cavity 90 through which the patient 80 can exhale through the nose can accumulate carbon dioxide if it is not flushed through the exhaust 40 contained in the elbow 60.
In the first embodiment of the present invention, the exhaust assembly is provided with two alternative exhausts, exhaust part a and exhaust part b as shown in FIGS. 4a-5c. Both exhaust part a and exhaust part b provide approximately the same overall flow rate. The exhaust part a is provided with relatively few large exhaust holes, while the exhaust part b is provided with a matrix of relatively small holes (for example, a diameter of 0.5 mm or less, preferably about 0.1 mm in diameter). The selection of the exhaust part a and the exhaust part b is performed by rotating or sliding the cover so that either the small hole or the large hole fits the orifice on the mating surface.
As shown in exploded views in FIGS. 4 a and 4 b, an exhaust assembly 90 according to one embodiment of the present invention includes a generally cylindrical first portion 100 and a generally cylindrical sleeve portion 110. . This first portion 100 includes an orifice or window 102. The sleeve portion 110, in one embodiment, includes two alternative sets of holes that correspond to the exhaust a and exhaust b, respectively. The exhaust part a uses three large holes. The exhaust b uses a series of smaller holes. In use, the sleeve portion 110 is rotationally fitted over the end of the first portion 100. In other embodiments, the sleeve can rotate less than an angle, but in the embodiment of the invention shown in FIG. 4a, the sleeve is free to rotate through 180 ° as indicated by the arrows in FIGS. 5a-5c. To do. As shown in FIGS. 4 a and 4 b, both the first portion 100 and the sleeve portion 110 are hollow so that air passes between the interior of the first portion 100 and through the window 102 and from there. It can pass through either exhaust hole a or b. FIG. 4c shows details of the exhaust with small holes.
In a second embodiment of the present invention, the exhaust assembly is mounted on a swivel elbow 120, eg, a MIRAGE® VESTA ™ mask manufactured by ResMed Limited, as shown in FIGS. Formed as part of the swivel elbow used. The elbow 120 includes a shaft 130 having an orifice 132 therein. The axis 130 includes an alignment tab 134. The sleeve 140 includes a pair of alternative exhausts 142, 144 and a pair of slots 146, 148, each one associated with an exhaust, each adapted to receive an axial alignment tab. In use, the orifice 132 of the shaft 130 is aligned with either the exhaust 142 or 144. To change from one exhaust to another, the exhaust assembly is pulled apart, rotated 180 ° and reassembled. In this way, at least one of the exhausts 142 or 144 and only one is used at a time.
In a third embodiment of the invention, the exhaust assembly includes a moving part. This moving part can be placed in each of the two positions by aligning the protrusion on one part with the indentation on the corresponding part. Alternatively, the two positions can be easily defined by using suitable positioning structures such as detents, latches, etc. When the exhaust assembly is in the middle between the two exhaust locations, the protrusions act to separate the coincident portions so that the exhaust air flow is greater than either of the two correct locations. Can do. This results in a failsafe mechanism where the wrong position results in higher airflow (safe condition) and also higher noise (warning the user of the mistake). Generally speaking, the assembly can be configured such that a warning, for example noise, is produced when the exhaust is misaligned.
A typical exhaust has a number of exhaust holes. For example, three exhaust holes having a diameter of 2.7 mm. The effective area of the exhaust holes is generally smaller than the actual cross-sectional area of the exhaust holes. Small holes have a relatively small effective area, eg, about 10% smaller than large holes. The effective area of the exhaust part is the sum of the effective areas of the exhaust holes of the constituent elements. In one form, the alternative exhaust has the same effective area.
In another embodiment of the present invention, an alternative exhaust structure is used instead of using holes. For example, the exhaust part a and the exhaust part b are laminar flow elements such as those used in ULTRA MIRAGE® masks. In another form, a sintered material is used to form the exhaust. In another form, the exhaust is formed from a foamed polymer. A combination of different exhaust parts, for example, an exhaust part having holes and an exhaust part composed of a sintered material can be used. This assembly may comprise more than two exhausts, for example exhausts with holes, sintered exhausts and laminar element type exhausts.
In some cases, such as in clinical studies, it may be desirable to test the effectiveness of a particular treatment or mask and compare it to an appropriate control. For example, it may be desirable to test the effectiveness of an algorithm for performing nasal CPAP therapy. In such a situation, it would be desirable to be able to overlook the effect of wearing the mask itself. This can be accomplished by using a “sham” mask, eg, a mask with very large vents. An example of a false mask is taught in US Pat. The difficulty of using a dedicated “fake” mask is that patients may be aware that they are using a fake mask, or that they need to disturb their sleep to wear such a mask It can be.
The exhaust assembly may alternatively include a fake exhaust. Such a false exhaust will have very high permeability, eg large pores. The use of the present invention allows a clinician to switch from a “treatment” exhaust to a “fake” exhaust with minimal disruption to a sleeping patient, and thus more of a clinical study. It will be possible to obtain clear results.
In a preferred form, a plurality of different exhausts is an alternative, but in one form, one or more exhausts, eg, 1/2 exhaust a and 1/2 exhaust b can be used at once.
In an exhaust section having exhaust holes, the exhaust flow rate can be set to any desired level by increasing or decreasing the number of holes in the exhaust section. In this manner, the exhaust assembly according to the present invention can be designed to have pressure flow characteristics that simulate a prior art mask that uses an exhaust with holes.
For example, various materials such as polycarbonate (eg, MAKROLON), or other polyesters, stainless steel, sintered ceramics or PTFE, and foamed polymers may be used to construct the exhaust assembly. The use of a hydrophobic material such as PTFE for the small hole exhaust may be particularly advantageous to reduce hole blockage.
In an alternative form, instead of being attached to a pivoting elbow, the exhaust assembly 200 according to one embodiment of the present invention is attached on or as part of the patient interface frame 210. FIGS. 11 a-14 show a frame for a patient interface comprising two generally cylindrical end portions 220 interconnected to a generally rectangular backbone 230. A clip 240 is slidably disposed on the backbone 230. The clip 240 includes at least two alternative exhausts 250, 260. One or more orifices or windows of the backbone 230, similar to the orifices or windows 102, provide fluid communication with the interior of the patient interface. Alternatively, the exhaled air can be exhausted through the exhaust 250 or 260 by sliding the clip 240 to align the exhaust 250 or 260 with the orifice. FIG. 11a shows the clip 240 in a first position where the exhaust 260 is aligned with an orifice in the backbone and one or both exhausts 250 are sealed. FIG. 11b shows the clip 240 in a second position where one or both exhausts 250 are aligned with respective orifices in the backbone and the exhaust 260 is sealed.
22 and 23 show an alternative embodiment of the present invention with a nasal mask 300. This form of the present invention provides a slidable exhaust cover 310 that exposes a set of large exhaust holes 320 at a first position 305 and exposes a set of small exhaust holes 330 at a second position 315. Including. In one form, this large and small exhaust hole is molded in a silicon grommet 325 that can be removably inserted into the mask frame in the same manner as in Patent Document 2 and Patent Document 3. When the holes are exposed, an air passage between the interior of the mask and the exterior of the mask can be realized therethrough.
FIG. 23a illustrates another embodiment of the present invention having a mask assembly 700 with a shell 702 and a cushion attached to the shell 702 or otherwise provided on the shell. The shell 702 includes an opening 706 through which a gas suitable for breathing under pressure is supplied to an internal chamber defined by the shell 702 and the cushion. Alternatively, a swivel elbow can be provided in the front opening of the shell 702, in which case the elbow will include a conduit that supplies a gas suitable for breathing from a gas source to the front opening.
The shell 702 includes at least one aperture 708 that is formed in a rectangular shape for ease of viewing in this case. The apertures 708 may, for example, during application of CPAP or NIPPV treatment is configured to evacuate the continuous CO 2. The slidable exhaust plate 710 has first, second and third aperture portions that can be selectively aligned with the aperture 708 (via sliding along the direction of arrow A). 712, 714, 716. As shown in FIG. 23 a, the second aperture portion 714 is aligned with the shell aperture 708, while FIG. 23 b is in the transferred position where the third aperture portion 716 is aligned with the shell aperture 708. 710 is shown. Thus, the clinician or patient can change the exhaust characteristics of the mask.
As shown in FIG. 23c, which is a schematic partial cross-sectional view of FIG. 23a, the exhaust plate 710 can be held by a shell 702 so that it can be opened. For example, the shell 702 can include a pair of legs 702a that each form a groove 702b into which a leg portion 710a of the plate 710 can slidably engage.
FIG. 24 shows an alternative form of the invention with a nasal mask 400. This form of the invention includes an exhaust cover 410 connected by a hinge. In the form shown in FIG. 24, the exhaust cover is generally rectangular and one is connected by a hinge. Similar to the exhaust assembly shown in FIGS. 22 and 23, the holes of FIG. 24 can be molded into a detachable grommet 425. The exhaust cover 410 can alternatively block a set of small exhaust holes 430 and a set of large exhaust holes 420.
25a and 25b show an embodiment 500 of the present invention that incorporates a rotary exhaust cover 510 at first and second positions on the exhaust elbow, respectively. The exhaust cover 510 is generally disc-shaped with a window 525 passing therethrough. By rotating the exhaust cover 510 by, for example, 120 °, different sets of holes are exposed. In FIG. 25a, a set of large holes 520 are exposed. In FIG. 25b, a set of small holes 530 are exposed. Each set of holes 520, 530 includes a conduit in communication with the interior of the mask. In an alternative form (not shown), the rotatable exhaust cover includes a different set of holes and there is a fixed position window to which the exhaust cover is attached. By rotating the exhaust cover, the window is provided with different sets of exhaust holes, resulting in different exhaust characteristics.
Figures 25c to 25e show yet another embodiment of the present invention. As shown in the assembled view of FIG. 25 c, the frame 800 includes a pivoting elbow 802 that can rotate relative to the frame 800. The rear end 803 of the swivel elbow is connected or provided to the frame 800, while the lower end 805 is connected to pressurized air or other breathable gas source. An exhaust assembly 806 can be provided on the front portion of the elbow 802.
FIG. 25 d shows the frame 800 and elbow 802 without the exhaust assembly 806. The front portion 807 of the elbow 802 is similar to that shown in FIG. 7 and includes an exhaust opening 809 that continuously exhausts CO2 to the atmosphere. In the case of FIG. 7, the exhausted air is first directed to the exhaust cover 70 provided to cover the front portion of the elbow (see FIG. 2), and then the exhausted air is one or more apertures. Through 50 to the atmosphere.
As shown in FIG. 25d, at least a portion 810 is closed or blocked so that air cannot pass therethrough. Accordingly, the exhausted air is directed to pass only through the portion of the elbow that includes the exhaust opening 809. After the air is exhausted through opening 809, it is directed to exhaust assembly 806. In particular, the exhaust can be selectively directed to either the first exhaust portion 812 or the second exhaust portion 814, as shown in FIG. 25c.
The first exhaust portion 812 can be similar to the exhaust portion cover of FIG. 2 and is elastically stretched to fit and cover a lip 813 provided on the front portion 807 of the elbow 802. Can be made of any material. The first exhaust portion 812 may include one or more apertures 816 to exhaust the exhaled gas. Unlike the exhaust cover of FIG. 2, the first exhaust part 812 can rotate with respect to the elbow 802. The rotation allows the user or clinician to select whether the exhausted gas is directed to the first or second exhaust portion 812, 814.
FIG. 25e shows the exhaust assembly 806 in isolation. The exhaust assembly 806 includes an opening 818 adapted to engage a rim 813 disposed in the front portion of the elbow 802. The exhaust assembly includes an inner wall member 820 that partially divides the second exhaust portion 814 from a chamber 822 that communicates with the first exhaust portion 812. The chamber 822 and the second exhaust portion 814 may communicate with each other via an internal aperture 824 depending on the relative position of the exhaust assembly 806 with respect to the elbow 802.
For example, if the exhaust assembly is rotated such that the inner wall member 820 is aligned with the blocked portion 810 of the elbow 802 (FIG. 25d) and the opening 824 is aligned with the opening 809, the exhaust The gas being directed can be directed through the second exhaust portion 814. In this position, a part of the exhaust can also be exhausted through the first exhaust part 812. If the aperture 824 is aligned with the blocked portion 810, the exhausted air will be directed exclusively to the first exhaust portion 810. The blocked portion 810 may preferably include an elastic material that can easily form an air tight seal with the aperture 824.
The second exhaust portion 808 may be in the form of a cylinder that can be filled with foam 815 to reduce the likelihood of noise and / or cross-infection. As an alternative to foam, ceramic materials or GORE-TEX® can be used.
FIGS. 25f and 25g show yet another exhaust assembly 830 adapted for use with the frame and elbow shown in FIG. 25d, for example. The exhaust assembly includes a first exhaust portion 832 (FIG. 25g) similar to the first exhaust portion shown in FIG. 25c. The exhaust assembly 830 includes a second exhaust portion 834 that includes a plurality of apertures 836. The exhausted air depends on the relative rotational position of the exhaust assembly relative to the elbow, with the inner wall member 838 selectively aligned with the opening 809 or the blocked portion 810 of the elbow 802 (FIG. 25d). , Selectively directed to the first or second exhaust portion. In FIG. 25 f, the second exhaust portion 834 can be seen through the aperture 840. FIG. 25f also shows an opening 842 that is adapted to engage the rim 813 (FIG. 25d). The exhaust assembly 830 is more compact than the exhaust assembly shown in FIG. 25e.
Figures 26, 27a and 27b show an alternative form of the invention including a replaceable exhaust cartridge. In this form of the invention, the exhaust assembly includes a replaceable cartridge 630 having a shaft 600, a rotatable sleeve 620 including a window 625, and a hole therethrough. This exhaust assembly is shown in an exploded view in FIG. When assembled, the cartridge 630 is slid into place over the shaft 600 and under the sleeve 620. In the configuration shown in FIGS. 27a and 27b, the cartridge 630 is designed so that it cannot rotate about the longitudinal axis of the shaft 600 in use. In return, the sleeve 620 is designed to be rotatable with a different set of holes exposed in the cartridge 630 as shown in FIGS. 27a and 27b. In use, the holes in the cartridge 630 provide fluid communication from the interior of the shaft 600 to the atmosphere. Because the small holes can become clogged with use, the sleeve 620 can be rotated after a suitable period of time (eg, overnight). As a result, one cartridge can provide a clean set of exhaust holes every night for a week without the need for cleaning. At weekends, the cartridge can be disposed of and replaced with a clean one.
The advantages of the present invention include: When in a quiet position (fine holes), the mask is extremely quiet and without any perceived air jet. This makes the mask much less disturbing both the wearer and the bed partner.
When in the normal (large hole) position, this mask is suitable for use with humidifiers that may block smaller holes. When a humidifier is not required, the exhaust assembly can be easily switched to a quiet, small hole exhaust.
This use of movable parts means that the patient does not have to hold spare parts and is excluded from losing components or being unable to fit them.
Use of the present invention allows the mask to be compatible with different flow generator or blower ranges. For example, a first flow generator or blower can be pre-programmed to operate with a first exhaust characteristic and a second blower with a second exhaust characteristic. Since the same mask can simulate different exhaust characteristics, the same mask can be used for both blowers after setting the appropriate exhaust.
Another advantage of the present invention is to provide different exhausts for different pressure ranges. For example, at low pressures, it may be appropriate to have an exhaust with large holes to allow a sufficient exhaust flow rate. The same exhaust at higher pressure will have an unnecessarily high exhaust flow rate leading to increased noise. Thus, according to one embodiment of the present invention, the first exhaust can be used when the patient is using an overall low pressure therapy, but the second exhaust when the therapy pressure is higher. Part can be used.
Another advantage of the present invention is that it provides a quick and simple system for disposable exhaust replacement. For example, certain types of exhausts can easily block and are designed for overnight use. According to one embodiment of the invention, the exhaust assembly may comprise a set of “disposable” exhausts. After first night use, the patient can switch to the second exhaust. After use on the second night, the patient can switch to the third exhaust, and so on.
In another form of the invention, sensors and / or indicators are included in the exhaust assembly as shown in FIGS. The exhaust assembly 300 includes a shaft 302 and a sleeve 304. The shaft 302 includes an orifice 306 through which air can pass. By rotating the sleeve 304, the alternative exhausts 308 and 310 are aligned over the orifice 306. The sensor detects which of the exhausts is being used and communicates that information to the flow generator controller. In one form, this sensor has a different electrical resistance depending on the exhaust used as shown in FIG. 21 and is discussed further below. Sensor information can be communicated to the flow generator controller via a line along the air supply conduit or wirelessly, eg, via a BLUETOOTH ™ compatible system. The flow generator controller receives the sensor information and adjusts parameters for the algorithm controlled therapy. Alternatively or additionally, the exhaust assembly includes an exhaust location indicator that may be visual, audible, tactile, or some combination. As shown in FIG. 20, the exhaust assembly 300 includes an alignment arrow 312 molded on the shaft 302. Each exhaust 308, 310 has an adjacent indicator (eg, arrow, point or some other shape) 309, 311 that is molded onto the sleeve 304. The indicating unit can be given a characteristic tactile sensation according to the position of the exhaust unit so that it can be recognized in the dark. Additionally or alternatively, the exhaust assembly may exhibit a characteristic “click” when the exhaust is changed as shown in FIG. This exhaust part assembly may display tags of different colors according to the exhaust part position.
FIG. 21 shows a schematic view of a slidable cover 350 that forms part of an exhaust assembly similar to FIGS. When a suitable exhaust 352 or 354 is aligned over an orifice (not shown), a corresponding resistor 353 or 355 electrically connects to a connector 356 that is in electrical communication with the flow generator controller 358. . As a result, the flow generator controller 358 can detect which exhaust is being used and adjust the blower pressure, flow, or some other parameters as needed.
This ability to communicate selected exhausts to the flow generator allows the flow generator to provide an appropriate response. The response may be for adjusting the control algorithm to take into account the recognized and selected characteristics of the exhaust. Additionally or alternatively, when the user attempts to initiate therapy by selecting an exhaust below the optimum exhaust, or when the selected exhaust characteristics are not recognized by the flow generator, the flow generator is It is also possible not to operate in the mode or to operate only within a predetermined pressure range.
Additionally or alternatively, the flow generator can facilitate the selection of the optimal exhaust for a given control algorithm or air circuit configuration. Upon detecting the exhaust selection, the flow generator may present a notification to the user. This notification can be by audible or visual alarm. Through the use of a flow generator status display (usually an alphabetic and numeric LCD panel), the flow generator presents a statement regarding the detected exhaust status and confirms its suitability or correct action Both can be proposed.
Since the present invention allows selection between exhausts, the flow generator informs the user whether the selected exhaust is satisfactory or unsatisfactory according to the therapeutic pressure range set to be delivered. It is possible. For higher pressures, this flow generator encourages the use of small holes, while larger holes can be proposed if it should be operated in a lower pressure range.
Alternative exhaust if the flow generator can detect deterioration in exhaust performance over time (eg, due to exhaust becoming blocked during one treatment period or several periods) Advice to prompt you to select a department can be given.
When such a system can be used, the air circuit arrangement may include a humidifier. If the air circuit is set to operate with a humidifier but the flow generator detects that a small hole (eg, mesh exhaust) is selected, the flow generator is more appropriate A notification can be sent to the user to prompt the selection of the exhaust.
Therefore, the flow rate and the noise level can be adjusted by the above embodiment. For example, by switching from an exhaust with large holes to an exhaust with small holes and / or foam, the flow rate and / or noise level is about 5-50%, preferably about 15-35%, most preferably about It can be reduced by 20-30%. In the embodiment of FIGS. 11a-14, the flow rate for large holes can be about 45-55 liters / minute, while the flow rate for small holes can be about 55-65 liters / minute. . In another embodiment, depending on patient requirements and mask construction, the flow difference between the smaller and larger holes can be stated to some extent.
Although the invention has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the application of the principles of the present invention. Many modifications can be made to this, and other structures can be devised without departing from the spirit and scope of the invention.
For example, in the embodiment shown in FIGS. 28a and 28b, a mask, such as mask 30 of FIG. 1, can be provided with two or more elastic exhaust inserts, each having different flow characteristics. In FIG. 28a, the exhaust 31 has a plurality of relatively larger holes 33, but the exhaust 35 of FIG. 28b can have a greater number of relatively small holes 37. The clinician / patient can change the exhaust to best fit the desired noise and / or flow characteristics.
The following embodiment can also be adopted.
1. Frame,
A cushion provided on the frame;
An exhaust part assembly including a first exhaust part, a second exhaust part, and a switch for switching a flow of exhaled gas from a patient between the first exhaust part and the second exhaust part; ,
A mask assembly for a patient, comprising:
2. 2. The mask assembly according to claim 1, wherein the first exhaust part and the second exhaust part include at least one characteristic regarding noise and / or flow rate that is different from each other.
3. 3. The mask assembly according to claim 1 or 2, wherein the frame includes a shell, and the exhaust part assembly is provided on the shell.
4). The cushion includes a nozzle element, and the switch includes a clip that is slidable relative to the frame to select between the first exhaust and the second exhaust. The mask assembly according to any one of 1 to 3.
5. The mask assembly according to any one of claims 1 to 4, wherein the switch is rotatable.
6). The mask assembly according to any one of 1 to 5, wherein the switch is rotatable.
7). The mask assembly according to any one of 1 to 6, wherein the switch is slidable.
8). 8. The mask assembly according to any one of 1, 2, and 4 to 7, wherein the frame includes an elbow, and the switch is provided on the elbow.
9. 9. The mask assembly according to claim 8, wherein the switch is provided on a corresponding arm of the elbow.
10. One of the first exhaust and the second exhaust comprises a material configured to reduce at least one of noise level and risk of cross-infection 1 The mask assembly according to any one of claims 9 to 9.
11. 11. The mask assembly according to 10, wherein the material is selected from the group consisting of foam, GORE-TEX® and ceramic.
12 The switch is adjustable between a first position and a second position corresponding to the first exhaust part and the second exhaust part, respectively, and the switch is the first position and the second position. The mask assembly according to any one of 1 to 11, further comprising a positioning structure for defining a position.
13. 13. The mask assembly according to 12, wherein the positioning structure includes a detent.
14 The mask according to claim 12 or 13, wherein the exhaust part assembly is configured to exhaust the discharged gas even when the exhaust part assembly is not in the first or second position. Assembly.
15. The mask assembly according to any one of claims 12 to 14, wherein an alarm is sounded when the exhaust assembly is not in the first or second position.
16. 16. The mask assembly according to claim 15, wherein the alarm is defined by a higher noise level generated by the exhaust assembly.
17. An exhaust section comprising: a first exhaust section; a second exhaust section; and a switch for switching a flow of gas exhaled from a patient between the first and second exhaust sections. Assembly.
18. 18. The exhaust assembly according to 17, wherein the first exhaust unit and the second exhaust unit include at least one of characteristics relating to noise and / or flow rate that are different from each other.
19. The exhaust part assembly according to 1 or 2, wherein the switching unit is rotatable, rotatable, and / or slidable.
20. 17-19, wherein one of the first and second exhausts comprises a material configured to reduce at least one of noise level and risk of cross-infection The exhaust part assembly according to any one of the above.
21. 21. The exhaust assembly according to 20, wherein the material is selected from the group consisting of foam, GORE-TEX®, and ceramic.
22. The switch is adjustable between a first position and a second position corresponding to the first exhaust part and the second exhaust part, respectively, and the switch is the first position and the second position. The exhaust part assembly according to any one of 17 to 21, further comprising a positioning structure for defining a position.
23. 23. The exhaust assembly according to 22, wherein the positioning structure includes a detent.
24. 24. The structure according to claim 22 or 23, wherein the exhaust part assembly is configured to exhaust the exhaled gas even when the exhaust part assembly is not in the first or second position. Exhaust part assembly.
25. 25. The exhaust assembly according to any one of claims 22 to 24, wherein an alarm is sounded when the exhaust assembly is not in the first or second position.
26. 26. The exhaust assembly of claim 25, wherein the alarm is defined by a higher noise level generated by the exhaust assembly.
10 Blower 20 Air Supply Conduit 30 Patient Interface 40 Exhaust 50 Hole 60 Elbow 70 Exhaust Cover 80 Patient 90 Cavity, Exhaust Assembly 100 First Part 102 Orifice or Window 110 Sleeve Part 120 Elbow 130 Shaft 132 Orifice 134 Tab 140 Sleeve 142, 144 Exhaust part 146, 148 Slot 200 Exhaust part assembly 210 Frame 220 End part 230 Backbone 240 Clip 250, 260 Exhaust part 300 Nose mask 305 First position 310 Exhaust cover 315 Second position 320 Large exhaust hole 325 Grommet 330 Small exhaust hole 400 Nose mask 410 Exhaust part cover 425 Grommet 420, 430 Exhaust hole 510 Exhaust part cover 525 Window 520, 530 Hole 600 Shaft 620 Sleeve 625 Window 630 Cartridge 700 Mask assembly 702 Shell 706, 708 Opening opening 710 Exhaust plate 712, 714, 716 First, second, third opening part 800 Frame 802 Elbow 806 Exhaust part assembly 809 Opening part 810 Blocking part 822 Chamber 824 Opening opening 830 Exhaust part assembly 843 Opening part
A vent assembly for flushing gas from a patient receiving a flow of suitable gas into the breathing pressure of at least 4 cmH 2 O,
The exhaust assembly is
An exhaust section assembly comprising: an exhaust section; and a controller that generates a signal to change a flow rate through the exhaust section.
The exhaust part assembly according to claim 1, wherein the exhaust part includes a first exhaust part and a second exhaust part.
The switch further comprises a switcher adjustable between first and second positions corresponding to the first exhaust part and the second exhaust part, respectively, the switcher having the first and second positions. The exhaust part assembly according to claim 2, further comprising a positioning structure for defining the exhaust part assembly.
The exhaust assembly according to claim 3, wherein the positioning structure includes a detent or a latch.
5. The exhaust unit according to claim 3 or 4, wherein the exhaust unit is configured to exhaust the discharged gas even when the switch is not in either the first or second position. Exhaust part assembly.
6. An exhaust assembly according to any one of claims 3 to 5, wherein an alarm is sounded when the switch is not in either the first or second position.
The exhaust assembly according to claim 6, wherein the alarm is defined by a higher noise level generated by the exhaust assembly.
The controller has a first resistance when the gas flush passes through the first exhaust, and has a second resistance different from the first resistance when the gas flush passes through the second exhaust. The exhaust part assembly according to any one of claims 2 to 7, further comprising a sensor having the same.
The exhaust part assembly according to any one of claims 3 to 8, further comprising an indicator for indicating which exhaust part is selected.
The exhaust assembly according to claim 9, wherein the indicator is visual, auditory, tactile, or any combination thereof.
The exhaust part assembly according to any one of claims 2 to 10, wherein the first and second exhaust parts include at least one of different characteristics relating to noise and / or flow rate.
12. An exhaust assembly according to any one of claims 2 to 11, wherein the first and second exhaust sections provide substantially the same overall flow rate.
12. The exhaust assembly according to any one of claims 2 to 11, wherein the first and second exhaust sections provide different flow rates.
The first exhaust portion includes a plurality of first exhaust holes, and the second exhaust portion includes a plurality of second exhaust holes. Exhaust part assembly.
The exhaust part assembly according to claim 14, wherein the number of the plurality of first exhaust holes is different from the number of the plurality of second exhaust holes.
16. The exhaust part assembly according to claim 15, wherein the number of the plurality of first exhaust holes is smaller than the number of the plurality of second exhaust holes.
The plurality of first exhaust holes have a first dimension, and the plurality of second exhaust holes have a second dimension smaller than the first dimension. The exhaust part assembly according to claim 16.
18. The exhaust part assembly according to claim 2, wherein an effective area of the first exhaust part is the same as an effective area of the second exhaust part.
19. The second exhaust part reduces the flow rate and / or noise level by about 5 to 50% compared to the first exhaust part. Exhaust part assembly.
20. The exhaust assembly of claim 19, wherein the second exhaust reduces a flow rate and / or noise level by about 15 to 35% compared to the first exhaust.
21. The exhaust assembly of claim 20, wherein the second exhaust reduces a flow rate and / or noise level by about 20-30% compared to the first exhaust.
The first exhaust part has a flow rate through the first exhaust part of about 45 to 55 liters / minute, and the second exhaust part has a flow rate through the second exhaust part of about 55 to 65 liters / minute. The exhaust part assembly according to any one of claims 2 to 21, wherein the exhaust part assembly is provided.
One of the first and second exhausts is provided with a material configured to reduce at least one of noise level and risk of cross-infection. Item 23. The exhaust part assembly according to any one of Items 2 to 22.
24. The exhaust assembly according to claim 23, wherein the material is selected from the group consisting of foam, porous polytetrafluoroethylene (PTFE), and ceramic.
The exhaust part assembly according to any one of claims 1 to 24, wherein the exhaust part is formed of polycarbonate, stainless steel, sintered ceramic, PTFE, or foamed polymer.
The exhaust part assembly according to any one of claims 1 to 25, wherein the exhaust part is formed of a hydrophobic material.
A mask assembly comprising:
A cushion assembly, comprising: a cushion provided on the frame; and an exhaust assembly according to any one of claims 1 to 26.
28. The mask assembly according to claim 27, wherein the frame includes a shell, and the exhaust portion is provided on the shell.
The shell includes an orifice, the exhaust portion includes a clip slidably disposed on the shell, and the first exhaust portion is aligned with the first exhaust portion and the orifice. The second exhaust is selected by sliding the clip such that the second exhaust and the orifice are aligned. The mask assembly according to claim 28.
The first exhaust portion and the second exhaust portion are provided in the shell, and the switch includes a cover pivotally attached to the shell. The mask assembly according to any one of the above.
The first exhaust part and the second exhaust part are provided in the shell, and the switch includes a cover slidably attached to the shell. The mask assembly according to any one of the above.
32. The mask assembly according to claim 30, wherein the first and second exhaust parts are provided in a grommet that can be removably inserted into the shell.
28. The mask assembly according to claim 27, wherein the frame includes an elbow, and the exhaust portion is provided on the elbow.
The exhaust includes a cylinder having an orifice and a sleeve that fits across the cylinder and includes the first and second exhausts, the sleeve and the cylinder being movable relative to each other and selectively 34. The mask assembly according to claim 33, wherein the first and second exhaust parts and the orifice are aligned with each other.
35. The mask assembly of claim 34, wherein the cylinder and the sleeve are rotatable relative to each other.
36. The mask assembly of claim 35, wherein the cylinder and the sleeve are slidable relative to each other.
The cylinder is aligned with the first alignment slot when the first exhaust is selected, and is aligned with the second alignment slot when the second exhaust is selected. 37. A mask assembly as claimed in any one of claims 34 to 36 comprising a configured alignment tab.
34. The mask assembly of claim 33, wherein the switch comprises a rotary cover configured to selectively cover the first and second exhausts.
The exhaust portion is provided in a front portion of the elbow including the exhaust opening and the blocked portion, and the exhaust portion selectively aligns the first exhaust portion and the second exhaust portion with the exhaust opening. 34. The mask assembly of claim 33, wherein the mask assembly is rotatably connected to the front portion.
The first exhaust part comprises at least one opening for exhausting gas exhaled from the exhaust opening, and the second exhaust part comprises at least one of noise level and risk of cross-infection. 40. The mask assembly of claim 39, comprising a material configured to reduce one.
The exhaust unit includes an inner wall that divides the second exhaust unit from a chamber communicating with the first exhaust unit, and the second exhaust unit and the chamber selectively communicate with each other via an internal opening. 41. A mask assembly according to claim 40.
The alignment of the shielded portion of the elbow and the inner wall is performed by aligning the opening that opens to the gas directly discharged through the second exhaust portion and the internal opening. Item 42. The mask assembly according to Item 41.
43. A mask according to claim 41 or claim 42, wherein the alignment of the internal opening and the blocked portion of the elbow guides the exhaled gas through the first exhaust part. Assembly.
The exhaust includes a cylinder, a sleeve that fits across the cylinder and includes a window, and a cartridge that includes a plurality of holes, the sleeve for selectively aligning portions of the plurality of holes to the window. 34. The mask assembly of claim 33, wherein the mask assembly is rotatable with respect to the cylinder and cartridge.
27. A flow generator for supplying a flow of respirable gas at positive pressure, the flow generator receiving a signal from an exhaust assembly according to any one of claims 1 to 26. It is comprised so that the flow rate generator characterized by the above-mentioned.
46. The flow generator of claim 45, wherein the controller is configured to adjust parameters of the flow generator control algorithm based on the received signal.
The controller may prevent the flow generator from operating when the selected exhaust is lower than the optimal exhaust for treatment or when the characteristics of the selected exhaust are not recognized by the controller or The flow rate generator according to claim 46, wherein the flow rate generator is configured to be controlled so as to operate within a predetermined pressure range.
48. A flow generator according to claim 46 or 47, wherein the controller is configured to facilitate selection of an exhaust section optimal for the control algorithm.
49. A flow generator as claimed in any one of claims 46 to 48, wherein the controller is configured to present a notification regarding the selected exhaust.
The flow generator of claim 49, wherein the notification is presented on a display.
51. A flow generator according to any one of claims 46 to 50, wherein the controller is configured to detect a degradation in performance of the selected exhaust.
The flow rate generator according to any one of claims 45 to 51, wherein a humidifier is combined.
53. A flow generator according to any one of claims 45 to 52 in combination with a mask assembly according to any one of claims 27 to 44.
JP2011228725A 2003-11-25 2011-10-18 Vent system for continuous positive airway pressure patient interface used in treatment of sleep disordered breathing Pending JP2012011243A (en)
JP2006540091 Division 2004-11-25
JP2012011243A true JP2012011243A (en) 2012-01-19
JP2006540091A Pending JP2007512047A (en) 2003-11-25 2004-11-25 Exhaust system for continuous positive airway pressure patient interface used to treat sleep breathing disorders
JP2011228725A Pending JP2012011243A (en) 2003-11-25 2011-10-18 Vent system for continuous positive airway pressure patient interface used in treatment of sleep disordered breathing
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