The present invention relates to a nasal assembly used for treatment, e.g., of Sleep Disordered Breathing (SDB) with Continuous Positive Airway Pressure (CPAP) or Non-invasive Positive Pressure Ventilation (NPPV).
Some nasal assemblies used in the treatment of SDB are designed for insertion into or adjacent the nasal passages of the patient. Air or other breathable gas is supplied by a blower and passed along a flexible conduit to the nasal assembly.
The nasal assembly generally includes a relatively rigid shell, e.g., a frame, and a pair of nozzles (which may be in the form of nasal pillows, nasal prongs, cannula, or nasal puffs) that are mounted on the rigid shell and structured to be inserted into or adjacent the nasal passages of the patient. The nozzles are usually held in place using a headgear assembly, the relatively rigid shell and headgear assembly being joined using some form of connector.
One form of known nasal assembly is described in U.S. Pat. No. 4,782,832 (Trimble et al.). Trimble discloses a nasal puff assembly 20 that includes a nasal puff 22 adapted to be worn adjacent the nose of a patient, together with a harness assembly 24 adapted to be worn over the head of the patient. The harness assembly 24 is designed to operatively hold puff 22 adjacent and partially within the nasal passages of the patient.
The puff 22 is in the form of a generally Y-shaped rigid hollow plenum chamber 28 together with a pair of laterally spaced apart nares elements 30. Adjustability of the nares elements 30 may be provided by rotatably mounting the elements 30 to the plenum chamber 28 and mounting the elements 30 in slots permitting selective lateral positioning of the elements 30 with respect to each other. Also, the harness assembly 24 may be adjusted to adjust the fit and seal of the nares elements 30 during use. That is, the force required to maintain a sufficient seal is directly associated with the force required to maintain a desired fit. Thus, adjustment of the fit or stability of the nasal assembly directly affects the seal, which can adversely affect patient comfort.
Other examples of nasal pillows or cannula mounted to rigid shells are disclosed in U.S. Pat. Nos. 5,724,965 and 6,431,172.
A nasal mask assembly manufactured by Viasys, i.e., Spiritus, includes a plenum chamber with a pair of adjacent or laterally spaced nares elements. A harness assembly is engaged with the plenum chamber to adjust the fit and seal of the nares elements during use. Similar to Trimble, adjustment of the fit or stability of the nasal assembly directly affects the seal, which can adversely affect patient comfort.
A nasal mask assembly manufactured by InnoMed, i.e., Nasal Aire, includes a plenum chamber with a pair of adjacent or laterally spaced nares elements. The nares elements are structured to engage within the mucosal surfaces or internal passages of the patient's nose to maintain the nasal mask assembly on the patient's face and to provide a seal. See, e.g., U.S. Pat. No. 5,533,506.
A nasal mask assembly manufactured by Stevenson Industries (see U.S. Pat. No. 6,012,455), i.e., CPAP-Pro, includes a dental anchor, a platform, and air supply tubes having nasal pads, wherein the platform supports the air supply tubes. The dental anchor is sized to be engaged between the teeth in the patient's mouth so as to retain the assembly in place.
PCT Application Publication No. WO 00/13751 discloses a device that includes gas delivery elements positioned into engagement with the patient's nose by a mouthpiece fitted to the patient's teeth.
A common problem with known nasal assemblies, such as those discussed above, is patient comfort. For example, the prongs tend to irritate the patient's nose due to the tension applied by the headgear assembly that pulls the rigid shell and prongs towards the patient's nose.
Another problem is achievement of a sealing fit with the patient's nasal passages without sacrificing patient comfort.
Another problem is irritation of the inside of the patient's nostrils caused by contact with the prongs, e.g., an edge thereof.
Another problem is irritation of the inside of the patient's nostrils caused by air jetting (air flow irritation) from the prongs.
Another problem is adjustment of the nasal assemblies relative to the nose and/or head of the patient so as to accommodate various shapes and angles of patient's noses.
Still another problem is the direct association between sealing and stability forces that can affect patient comfort.
Still further nasal assemblies are known from the current assignee's co-pending U.S. Non-Provisional application Ser. Nos. 11/101,657, filed Apr. 8, 2005, and 10/781,929, filed Feb. 20, 2004, each incorporated herein by reference in its entirety.
A further need has developed to even further reduce the noise associated with the washout or venting of exhaled gases from the breathing chamber.
One aspect of the invention is directed towards a nasal assembly, in particular an improved cushion/frame/vent/clip assembly having an improved frame, cushion, vent and/or clip component. The assembly may effectively reduce the noise associated with gas washout or venting of the patient.
Another aspect of the invention is to prevent the use of an old-style frame (which has no vent holes) with a cushion as described herein (which also has no holes).
Another aspect of the invention is directed towards a frame that is easy and inexpensive to manufacture.
Another aspect of the invention is directed to a frame with a vent channel and a plurality of vent holes, in which case it is not necessary to provide the cushion with such gas washout vent holes.
According to another aspect of the invention, the clip may have ribs to improve strength/stiffness, and/or to allow ease of grip. The clip may also have wings with compound curvature to help improve strength/stiffness.
Another aspect of the invention provides a nasal assembly for delivering breathable gas to a patient. The assembly includes a frame having a main body and lateral sides, each lateral side including an integrally formed lateral connector; and a cushion including a pair of nozzles to communicate with nasal passages of a patient's nose in use, the cushion being coupled with the main body of the frame, wherein the frame includes a vent channel provided in the main body, the vent channel including a pair of side walls extending from the main body towards a base wall, said base wall including at least one vent hole.
According to another aspect of the invention, there is provided a nasal assembly for delivering breathable gas to a patient, comprising a frame having a main body and lateral sides, each lateral side including an integrally formed lateral connector; and a cushion including a pair of nozzles to communicate with nasal passages of a patient's nose in use, the cushion being coupled with the main body of the frame, wherein the frame includes a plurality of vent holes, said vent holes being provided in two or more rows arranged such that the vent holes are offset from one another.
According to another aspect of the invention, there is provided a nasal assembly for delivering breathable gas to a patient, comprising a frame having a main body and lateral sides, each lateral side including an integrally formed lateral connector; and a cushion including a pair of nozzles to communicate with nasal passages of a patient's nose in use, the cushion being coupled with the main body of the frame, wherein the frame includes longitudinal cushion channels to receive longitudinal edges of the cushion, at least one of said cushion channels including at least one cut out to receive a lug of the cushion upon assembly.
According to another aspect of the invention, there is provided a nasal assembly for delivering breathable gas to a patient, comprising a frame having a main body and lateral sides, each lateral side including an integrally formed lateral connector; and a cushion including a pair of nozzles to communicate with nasal passages of a patient's nose in use, the cushion being coupled with the main body of the frame, wherein the frame includes a circumferential cushion channel provided to each said lateral side of the frame, said frame including a cored portion generally aligned with each circumferential cushion channel, said cushion including a corner lug to interface with each said cored portion.
According to another aspect of the invention, there is provided a nasal assembly for delivering breathable gas to a patient, comprising a frame having a main body and lateral sides, each lateral side including an integrally formed lateral connector, the frame including at least one vent hole; a cushion including a pair of nozzles to communicate with nasal passages of a patient's nose in use, the cushion being coupled with the main body of the frame; and a clip to secure the cushion to the frame, wherein the clip includes a vent window generally aligned with the at least one vent hole.
According to still another aspect of the invention, there is provided a patient interface for delivering breathable gas to a patient, comprising a frame; a cushion to communicate with a patient's airways in use, the cushion being coupled with the frame; and a vent portion including a plurality of vent holes, said vent holes being provided in two or more rows and the rows being arranged such that the vent holes are offset from one another.
Yet another aspect of the invention relates to a full-face mask frame including a main body having a longitudinal axis and a vent assembly provided to the main body. The vent assembly includes a plurality of holes arranged in at least one column. The at least one column is aligned with or parallel to the longitudinal axis.
Yet another aspect of the invention relates to a mask frame including a main body and a side frame portion provided on each lateral side of the main body. A vent assembly is provided to each side frame portion. Each vent assembly includes a plurality of holes arranged in a multi-column pattern and each column is vertically staggered with respect to one another.
Yet another aspect of the invention relates to a nasal assembly for delivering breathable gas to a patient. The nasal assembly includes a frame and a cushion including a pair of nozzles to communicate with nasal passages of a patient's nose in use. The cushion is coupled with the frame. The cushion includes a size indicator, a series of position arrows, text, and/or a logo provided to one side of the cushion. The size indicator, series of position arrows, text, and/or logo are adapted to provide a visual cue to assist the patient in achieving correct alignment and orientation of the cushion and frame with respect to the patient in use.
Yet another aspect of the invention relates to a nasal assembly for delivering breathable gas to a patient. The nasal assembly includes a frame including a main body and a cushion including a pair of nozzles to communicate with nasal passages of a patient's nose in use. The cushion is coupled with the main body of the frame. The frame includes a vent channel provided in the main body. The vent channel includes a pair of side walls extending from the main body towards a base wall. Each of the side walls includes a variable wall thickness along its length.
Yet another aspect of the invention relates to a nasal assembly for delivering breathable gas to a patient. The nasal assembly includes a frame and a cushion coupled to the frame. The cushion includes a pair of nozzles to communicate with nasal passages of a patient's nose in use. The frame includes a vent channel that leads to at least one vent hole. The vent channel is adapted to buffer and/or separate higher velocity and more turbulent air flow into and around the frame from an entrance to the at least one vent hole.
Yet another aspect of the invention relates to a mask frame including a main body including an aperture adapted to communicate with an elbow and a vent assembly provided to the main body. The vent assembly includes a plurality of holes arranged around the aperture.
Other aspects, features and advantages of this invention will become apparent from the following detailed description when taken in conjunction with the accompanying drawings, which are a part of this disclosure and which illustrate, by way of example, principles of this invention.
The accompanying drawings facilitate an understanding of the various embodiments of this invention. In such drawings:
The following includes a description of one or more illustrated embodiments of the present invention. Each illustrated embodiment includes features that may be used with and/or in the other embodiments, or with the embodiments and/or components described in U.S. Non-Provisional application Ser. Nos. 10/781,929 and/or 11/101,657, as would be apparent to those of ordinary skill in the art. The general operation of the embodiments described herein is substantially identical to the operation of the embodiments detailed in U.S. Ser. No. 10/781,929 and U.S. Ser. No. 11/101,557, and therefore will not be repeated.
In the embodiment of
As shown in
Cushion assembly 15 includes a frame 65, a cushion 70 and a clip 75.
As shown in
Main body 80 of frame is provided with a vent channel 90 defined by a base wall 92 and a pair of side walls 94. Vent channel 90 extends from an inside surface 95 of the main body toward the base wall 92. An upper portion 100 of the vent channel 90 is positioned in a plane just below the lowest point 110 of the inlet aperture 115 of lateral connector 85.
Side walls 94 converge towards one another in the direction of the base wall at a slight angle alpha (α), e.g., about 2-5 degrees, preferably 2 degrees. Each side wall 94 has a lower portion 120 that is provided to the base wall 92 along a radius of curvature RL of about 0.2-0.4 mm, preferably about 0.3 mm, and the upper portion 100 that is curved, e.g., with a radius of curvature RU of between about 0.5 to 1.5 nm, preferably about 0.9 to 11.0 mm. The width WS between the side walls is about 2-3 mm, preferably about 2.6 mm. The width between the side walls increases in the direction of upper portion 100 due to the angle alpha (α), described above.
Channel 90 is in communication with a plurality of vent holes 130, e.g., 6-60 vent holes, and preferably about 35-45 vent holes, although there could be more than 60 holes or less than 6 holes, depending on application. In the example of
The vent holes in any of the above embodiments may be provided directly on the frame and/or the cushion. In an alternative, the frame, cushion and/or air delivery conduit can be provided with an aperture into which a substrate with the holes is inserted or otherwise provided. The substrate may take the form of an insert, such as disclosed in U.S. Pat. No. 6,561,190, incorporated herein by reference in its entirety. In another alternative, vent holes may be provided in headgear.
As can be seen from
Each hole 130 preferably has the following dimensions: length HL: about 1.0-2.5 mm, preferably about 1.7 mm; outlet diameter HO: about 0.5-1.0 mm, preferably about 0.7 mm; radius of curvature at the upper end of the hole (HR): about 0.15-0.35 mm, preferably about 0.25 mm.
Frame 65 includes lugs 140 (
Frame includes cored portions 160 (
The vent channel 90 of the frame 65 is structured to reduce vent noise generated by the vent holes. In the illustrated embodiment, the entrance to the vent holes 130 is located at the bottom of the vent channel 90. As a result, turbulent inflow is entrained into or guided within the vent channel 90 which decreases the turbulence of the flow in the mask chamber before the flow passes into the vent holes 130. Because the flow entering the vent is not highly turbulent, the noise induced by turbulent flow passing through the vent is reduced (effecting a noise reduction throughout the whole breathing cycle, not just inhalation).
The vent channel 90 also acts as a buffer between the high flow region (generally between the opposed inlet apertures 115) and the entrance to the vent holes 130. This arrangement has the effect of quieting the nasal assembly during inhalation when flow through the nasal assembly is at its highest and most turbulent.
Specifically, inflow during inhalation includes a relatively high velocity cross flow, wherein air enters the cushion assembly 15 laterally and normal to the orientation of the vent holes 130. Noise may be produced by this air flow if it encounters obstructions or irregularities, such as an array of vent holes. By providing the vent holes 130 at the bottom of the vent channel 90, the air flow does not directly encounter this irregular geometry. Therefore, noise generated from the vent holes 130 may be eliminated and/or reduced.
Cushion 70 includes a main body 170 supporting a pair of nozzle members 175 that are designed to engage with a user's nares in use.
As best shown in
Cushion 70 has no vent holes, since the vent holes are provided in the frame 65. However, the wall thickness of a portion 180 (
As shown in
Clip 75 includes a main body having lateral ends, either one of which can be assembled to the cushion/frame subassembly, by sliding action to secure same.
Clip 75 includes a vent window 190 that aligns with the vent holes in vent channel upon assembly of the clip to the cushion/frame subassembly.
Clip 75 includes ribs 195 provided on each lateral side thereof. Ribs 195 help with strength and stiffness, as well as provide a grip surface.
Clip 75 includes wings 200 on each side of the main body. Wings 200 preferably have a compound curved shape, to improve strength and stiffness.
Vent configurations, such as those described above, may be incorporated into other mask arrangements. For example,
As best shown in
In the illustrated embodiment, a vent assembly 600 is provided in each side frame portion 670 of the frame 650, adjacent the upper anchors 672. Each vent assembly 600 includes an array or pattern of relatively small holes 605 arranged in a plurality of columns, e.g., 3-10 columns, and in the example illustrated, 5 columns. The 5 columns are vertically staggered with respect to one another. Also, the first hole in each column cooperate to form an axis A that is angled at an angle α (when viewed from the front as shown in
As illustrated, the holes 605 are located away from the elbow aperture 662 to avoid air flow interference. Also, the holes 605 are located near headgear attachment points 672 where the frame 650 is relatively flat to the users face for the anchor structures. In addition, the holes 605 are positioned on relatively flat portions of the frame 650 so that air may be vented perpendicularly from the general plane of the patient's face to avoid air jetting towards a bed partner. Thus, this vent arrangement optimizes mask operation and is synergistic in that it utilizes an area of the frame 650 which is relatively flat to the patient's face for two purposes, i.e., anchor structure and perpendicular venting. Aesthetics of the frame 650 are also improved significantly by reducing the number of relatively flat areas that are provided on the frame 650.
As best shown in
The main body 780 of the frame 765 is provided with a vent channel 790 defined by a base wall 792 and a pair of side walls 794. The vent channel 790 extends from an inside surface 795 of the main body toward the base wall 792.
The channel 790 is in communication with a plurality of vent holes 830, e.g., 6-60 vent holes, and preferably about 35-45 vent holes, although there could be more than 60 holes or less than 6 holes, depending on application. In the example of
The frame 765 includes lugs 840 to help form a longitudinal cushion channel 845 into which an edge portion 771 of the cushion 770 is fitted, to secure the cushion 770 relative to the frame 765 to form a frame/cushion subassembly prior to attachment of the clip. The cushion channel 845 is provided on each side of the vent channel 790 and includes one or more cut outs 850 to receive corresponding lugs of the cushion 770 (as described above with respect to cushion 70 and frame 65). Frame 765 also includes circumferential channels 846 to receive end portions of the cushion 770.
In the illustrated embodiment, the side walls 794 of the frame 765 are locally thickened at the cut outs 850. Specifically, the wall sections S1 at the cut outs 850 (i.e., between lugs 840) are thickened with respect to the adjacent wall sections S2 supporting lugs 840. This arrangement increases the strength of the side wall 794′ to reduce bending stress, which results in an increase in strength of the overall frame 765.
For example, the wall section S1 between lugs 840 shown in
As shown in
The fillet size increase provides better stress distribution at the junction between the side walls 794 and the lugs 840. Thus, the fillet-size increase (along with the thickened side walls described above) results in overall strength improvement of the frame 765.
The cushion 770 is substantially similar to the cushion 70 described above. As illustrated, the cushion 770 includes a main body 870 supporting a pair of nozzle members 875 that are designed to engage with a user's nares in use.
The main body 870 of the cushion 770 includes a size indicator 702, e.g., medium (M) size, and a series of position arrows 704 to facilitate positioning between the headgear and the cushion assembly 715. In addition, the cushion 770 includes text and/or a logo 706, e.g., ResMed logo. As illustrated, the logo 706, the size indicator 702, and the position arrows 704 protrude from the main body 870, e.g., raised configuration, to facilitate recognition.
In the illustrated embodiment, the logo 706, the size indicator 702, and the position arrows 704 are provided on one side of the main body 870. This labeling arrangement provides a visual cue to assist the patient in achieving correct alignment and orientation of the cushion 770 and frame 765 with respect to the patient.
Specifically, the labeling arrangement prevents incorrect assembly of the cushion assembly 715 (i.e., cushion 770 and frame 765) onto the headgear. As shown in
Often, the frame 765 remains attached to the headgear and the cushion 770 is removed from the frame/headgear subassembly, e.g., for cleaning. When the cushion 770 is re-assembled to the frame 765 (e.g., see
In an embodiment, the logo 706, the size indicator 702, and/or the position arrows 704 may be provided to facilitate orientation.
The yoke 925 may include a yoke ring 955. The cushion assembly 915 may be adjustably rotated with respect to headgear, to a position which best fits the patient. The ring 955 of the yoke 925 associated with the other side of the headgear may include one or more alignment markers 961 that can be selectively aligned with one of a plurality of alignment markers 960 provided on the cushion.
The swivel elbow 935 includes one end provided to the cushion assembly 915 and the opposite end provided to an air delivery tube. As illustrated, the end provided to the cushion assembly 915 includes two prongs 937 and a pair of key-shaped apertures 939 (only one aperture being visible) to reduce stress. Such a swivel elbow is disclosed in PCT Application No. PCT/AU2004/000207, filed Feb. 20, 2004, the entirety of which is incorporated herein by reference.
The cushion assembly 915 includes a frame 965, a cushion 970 and a clip 975.
The frame 965 may be similar to one or more of the frames described above. Therefore, the frame 965 will not be, described in further detail.
The cushion 970 may be similar to one or more of the cushions described above. Therefore, the cushion 970 will not be described in further detail.
The clip 975 includes a main body having lateral ends, either one of which can be assembled to the cushion/frame subassembly, by sliding action to secure the same. Such a clip is disclosed in U.S. Design No. 29/258,084, filed Apr. 14, 2006, the entirety of which is incorporated herein by reference.
The clip 975 includes a vent window 1090 that aligns with the vent holes in vent channel upon assembly of the clip to the cushion/frame subassembly.
The clip 975 includes two ribs 1095, 1097 provided on each lateral side thereof. The two ribs 1095, 1097 increases stiffness to prevent disassembly of the clip 975, thus improving the retention and seal of the cushion 970 to the frame 965. In addition, the two ribs 1095, 1097 improve usability by providing grip during assembly/disassembly.
The clip 975 includes wings 1000 on each side of the main body. The wings 1000 extend laterally from a bottom of the clip 975 (e.g., in contrast to wings 200 that extend from a top surface of clip 75.
In addition, each wing 1000 has a reinforced section 1002 that increases stiffness in the clamping direction to prevent disassembly of the clip 975, thus improving the retention and seal of the cushion 970 to the frame 965.
In contrast to the frame 650, the frame 1150 includes a vent assembly 1100 that extends around the aperture 1162 and hence the elbow 1135 in use. As schematically shown in
In the illustrated embodiment, the holes 1105 are arranged in two concentric circles C1, C2 around the aperture 1162. However, the holes may be arranged in any number of circles around the aperture, e.g., 1-10 concentric circles. Also, each circle may include any suitable number of holes, e.g., 5-50 holes. The holes in adjacent circles may be aligned and/or offset from one another. However, the holes 1105 may be arranged in other suitable arrangements around the aperture 1162. For example, the holes 1105 may be non-concentrically arranged around the aperture 1162, e.g., randomly arranged. In addition, each hole 1105 may include a generally part conic shape as described above.
It should be appreciated that the vent assembly 1100 may be incorporated into other mask arrangements, e.g., nasal mask, full-face mask, etc.
The vent assembly 1100 described above may create noise when flow from the vent holes 1105 engages or blows into the back of the elbow 1135. To prevent this, a “keyed” elbow retaining clip may be used that is structured to mask holes when they are aligned with the elbow 1135.
The elbow 1135 includes a mating portion 1141 that is inserted into the aperture 1162 provided in the frame 1150, and the elbow retaining clip 1136 is attached to the mating portion 1141 from an inner side of the frame 1150 so as to prevent withdrawal of the mating portion 1141 and hence the elbow 1135 from the aperture 1162.
As illustrated, the mating portion 1141 includes a key or protrusion 1143 that is adapted to engage within a corresponding keyway or recess 1137 provided to the elbow retaining clip 1136. The engagement between the key 1143 and keyway 1137 ensures that the elbow retaining clip 1136 is correctly oriented with respect to the elbow 1135.
Moreover, the elbow retaining clip 1136 includes a wiper member or tab 1139 that is structured to block, cover, and/or mask one or more vent holes 1105 from the inner side of the frame 1150 which are aligned with the elbow 1135. This arrangement blocks vent flow from blowing into the back of the elbow 1135, which reduces noise in use. Because the elbow retaining clip 1136 is keyed with the elbow 1135, the wiper member 1139 will rotate along the elbow 1135 to block the affected vent holes, i.e. vent holes aligned with the elbow 1135.
This vent and elbow arrangement has several advantages. For example, the relatively small vent holes provides lower mask noise for the patient and bed partner, and the diffuse placement of the vent holes provides a lower risk of the bed partner being affected. Because there are less complaints from the bed partner, the mask provides greater compliance as the patient may be more willing to wear the mask.
While the invention has been described in connection with what are presently considered to be the most practical and preferred embodiments, it is to be understood that the invention is not to be limited to the disclosed embodiments, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the invention. Also, the various embodiments described above may be implemented in conjunction with other embodiments, e.g., aspects of one embodiment may be combined with aspects of another embodiment to realize yet other embodiments. Further, each independent feature or component of any given assembly may constitute an additional embodiment. In addition, while the invention has particular application to patients who suffer from OSA, it is to be appreciated that patients who suffer from other illnesses (e.g., congestive heart failure, diabetes, morbid obesity, stroke, bariatric surgery, etc.) can derive benefit from the above teachings. Moreover, the above teachings have applicability with patients and non-patients alike.
Number | Date | Country | Kind |
---|---|---|---|
29/258084 | Apr 2006 | US | national |
This application claims the benefit of U.S. Design No. 29/258,084, filed Apr. 14, 2006, and U.S. Provisional Patent Application Nos. 60/734,282, filed Nov. 8, 2005, 60/758,200, filed Jan. 12, 2006, 60/795,615, filed Apr. 28, 2006, 60/819,626, filed Jul. 11, 2006, and 60/838,442, filed Aug. 18, 2006, each of which are incorporated herein by reference in its entirety.
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/AU2006/001507 | 10/13/2006 | WO | 00 | 4/30/2008 |
Number | Date | Country | |
---|---|---|---|
60734282 | Nov 2005 | US | |
60758200 | Jan 2006 | US | |
60795615 | Apr 2006 | US | |
60819626 | Jul 2006 | US | |
60838442 | Aug 2006 | US |