Source: http://www.google.com/patents/US8042538?dq=6,910,205
Timestamp: 2014-09-01 14:45:36
Document Index: 97086773

Matched Legal Cases: ['Application No. 60', 'art) 130', 'Application No. 60', 'Application No. 2006', 'Application No. 567066', 'Application No. 591697', 'Application No. 541912', 'Application No. 579949', 'Application No. 2004212632', 'Application No. 2006', 'Application No. 200480004798', 'Application No. 200480004798', 'Application No. 200480004798', 'Application No. 04712965']

Patent US8042538 - Nasal mask assembly - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign in<nobr>Advanced Patent Search</nobr>PatentsA mask system is provided to fit pre-adult patients, or patients having facial features that are very small or child-like, e.g., patients having dimensions in the lower 5%-10% of the population. For example, the headgear and/or cushion are dimensioned to accommodate this range of patients....http://www.google.com/patents/US8042538?utm_source=gb-gplus-sharePatent US8042538 - Nasal mask assemblyAdvanced Patent SearchPublication numberUS8042538 B2Publication typeGrantApplication numberUS 10/781,949Publication dateOct 25, 2011Filing dateFeb 20, 2004Priority dateFeb 21, 2003Also published asCN1750853A, CN100566771C, EP1603617A1, EP1603617A4, US20040221850, US20120037161, WO2004073777A1, WO2004073777A8Publication number10781949, 781949, US 8042538 B2, US 8042538B2, US-B2-8042538, US8042538 B2, US8042538B2InventorsAnthony M. Ging, Philip R. Kwok, Gary C. Robinson, Bianto Santoso, Rachael E. Moore, Patrick J. McAuliffeOriginal AssigneeResmed LimitedExport CitationBiBTeX, EndNote, RefManPatent Citations (55), Non-Patent Citations (12), Classifications (23), Legal Events (2) External Links: USPTO, USPTO Assignment, EspacenetNasal mask assemblyUS 8042538 B2Abstract A mask system is provided to fit pre-adult patients, or patients having facial features that are very small or child-like, e.g., patients having dimensions in the lower 5%-10% of the population. For example, the headgear and/or cushion are dimensioned to accommodate this range of patients.
CROSS REFERENCE TO PRIORITY APPLICATIONS The present application claims the benefit of U.S. Provisional Patent Application No. 60/448,533 filed Feb. 21, 2003 and 60/465,790 filed Apr. 28, 2003, each of which is incorporated herein by reference in its entirety.
Sleep-disordered breathing is a general term for a sleep disorder with apneas and hypopneas. Apneas are generally taken to be a cessation of airflow for ten seconds or longer. Hypopnea are generally taken to be a 50% or greater decrease in air flow for ten seconds or longer. Both apneas and hypopneas cause sleep arousals�moments when an individual wakes enough to resume breathing but not enough to remember any interruption of sleep. Some arousals simply cause the sleeper to shift into a lighter stage of sleep. In either case, the arousal lessens the quality of sleep. Apneas and hypopneas may cause blood oxygen levels to drop. Apneas and hypopneas result from upper airway obstruction, either full or partial, or a dysfunction of the body's automatic drive to breathe.
A variety of nasal masks have been developed. One such mask is the MIRAGE� mask, manufactured by ResMed Limited and described in U.S. Pat. Nos. 6,112,746; 6,357,441; 6,119,693 and 6,463,931, amongst others. Another such mask is the ULTRA MIRAGE� mask, also manufactured by ResMed Limited. The ULTRA MIRAGE� mask is described in U.S. Pat. Nos. 6,112,746, 6,357,441, 6,374,826, 6,412,487, 6,439,230 and 6,463,931.
The American Academy of Pediatrics, in a Technical Report on the Diagnosis and Management of Childhood Obstructive Sleep Apnea Syndrome (OSAS) (PEDIATRICS Vol. 109 No. 4 April 2002.) noted that �Snoring is a common occurrence in childhood, with reported prevalence between 3.2% and 12.1%. The prevalence of childhood OSAS is difficult to estimate, largely because published studies use different PSG criteria for its ascertainment. Reports range from 0.7% to 10.3%.�
One mask designed for children is the SULLIVAN� Nasal CPAP system, Infant Nasal Bubble Mask System with Sensor tubing, manufactured by ResMed Limited. See FIG. 1. In addition, Respironics Inc. manufactures a �Comfort Flap Small Child� product.
One adult mask is the VISTA� mask, manufactured by ResMed Limited, and described in Australian Provisional Patent Application PS1926, filed 23 Apr. 2002; U.S. 60/377,254 filed 03 May 2002; U.S. 60/397,195 filed 22 Jul. 2002; U.S. 60/402,509 filed 12 Aug. 2002; and U.S. Ser. No. 10/391,440, 10/390,682, 10/390,681, 10/390,720 and 10/390,826, all filed 19 Mar. 2003, the contents of which are hereby incorporated by cross-reference. An ornamental design applied to the VISTA� mask is shown in design patent application US Des 29/166,190, the contents of which are hereby incorporated by reference.
The VISTA� mask includes a cushion, a frame, an elbow and headgear including a yoke.
While the VISTA� mask is particularly suitable for adults, the problem arises as to how such an adult mask can be adapted to suit children.
� . . . until now, infant masks have been developed on the basis of scaling down the adult mask to approximate to the infantface and nose. The problems with this scaling down process are threefold.
Thirdly, because the attachment of the paediatric mask to the face and head mimics that of the adult mask, the torsional forces are increased. The greater torsional effect is due to the decreased surface area of the mask face contact relative to the air delivery pipe. Thus relatively minor movements can result in sufficient torsional forces to cause movement at the interface between the mask and the infants face.�
SUMMARY In accordance with a first aspect of the invention a mask assembly suitable for pre-adults is provided.
BRIEF DESCRIPTION OF FIGURES Preferred embodiments will be described in relation to the following drawings, in which:
FIG. 2 shows a perspective view of a related art VISTA� mask on an adult patient;
FIG. 3 shows a side view of the VISTA� mask;
FIG. 4 shows a front view of the VISTA� mask;
FIG. 5 shows a side view of a headgear yoke of the VISTA� mask;
FIG. 11 is a plan view comparing the central rear headgear strap of FIG. 10 and the VISTA�;
FIG. 12 shows a plan view of a cushion, mounted on a frame, in accordance with an embodiment (the �Kid cushion�) of the invention;
FIG. 13 shows a top elevation view of the �Kid� cushion;
FIG. 14 shows a side elevation view of the �Kid� cushion (without the frame);
FIG. 15 shows a bottom elevation view of the �Kid� cushion;
FIG. 16 shows a perspective view of the �Kid� cushion;
FIG. 17 shows a plan view of the �Kid� cushion compared to other cushion shapes;
FIG. 18 shows a rear review of an underlying rim of the �Kid� cushion showing the change in dimension compared with an adult VISTA�;
FIG. 19 shows of a membrane of the �Kid� cushion showing the change in dimension compared with an adult VISTA� cushion;
FIG. 20 shows the edge of the membrane of the �Kid� cushion and the more rounded lower corners of the �Mini� cushion;
FIG. 22 illustrates a rear view of a �Kid� cushion in accordance with the present invention;
FIG. 23 illustrates a bottom view of a �Kid� cushion in accordance with the present invention, in comparison to the VISTA� and/or other earlier embodiments;
FIG. 24 illustrates a top view of a �Kid� cushion in accordance with the present invention;
FIG. 25 illustrates a side view of a �Kid� cushion in use, in accordance with the present invention;
FIG. 27 illustrates a sample fitting chart plotting nose width v. nose or bridge height in accordance with the present invention, comparing the VISTA�, the Kidsta Small and the Kidsta Extra Small;
FIG. 28 illustrates cross-sectional views comparing the cushions of the �Kid�, the Kidsta Small and the VISTA�;
FIG. 29 illustrates partial plan views comparing the �Kid�, Kidsta Small and VISTA� cushions;
FIG. 31 illustrates partial cross-sectional views comparing the cushions of the �Kid�, Kidsta Small and VISTA�;
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS FIGS. 2-5 illustrate a related art mask known as the VISTA�, manufactured by ResMed Incorporated. Mask assembly 100 comprises (i) a soft face-contacting cushion 110, (ii) swivel elbow 130, (iii) headgear clips 140, (iv) a frame 120 adapted to receive the cushion 110 and support swivel elbow 130 and headgear clips 140, and (v) headgear 150 including straps 160 and a headgear yoke 170.
Stabilization of the cushion 110 and frame 120 on the face 220 of an adult patient 200 is assisted by the size, shape and positioning of the yoke 170 on the headgear 150. In spite of the problems identified by Sullivan & Wilkie concerning the fulcrum and torsional effects of prior art masks, greater stability can be achieved in pre-adults with a mask in accordance with the present invention. In one embodiment, the present inventors have redesigned the VISTA� mask in FIGS. 2-5 to be suitable for use with pre-adults, or adults with small or child-like facial features.
FIGS. 6-16 illustrate components of a mask system for use with pre-adults, in accordance with preferred embodiments of the present invention, in which like elements are referenced by like elements compared to the VISTA� shown in FIGS. 2-5.
1. yoke vertical finger 310 located midway between eye-line 230 and earlobe 240 (refer to FIG. 2). 2. yoke ladderlock 320 located ⅓ of the distance between the eye-line 230 and crown of the head 250. 3. a gap of 5 mm maintained between lower yoke finger 330 and lowest point of earlobe 240. 4. lower yoke finger 330 positioned about 15 mm behind the lowest point of the earlobe 240. 5. a lower yoke finger 330 positioned at an angle of about 15-20�, preferably 17�, like the VISTA�. Table 4 compares dimensions of related art VISTA� headgear yoke with two �small� headgear yokes, referred to as the �Mini� and �Kid,� in accordance with preferred embodiments of the invention. The first row of Table 4 identifies four features (A, B, C and D) of the headgear yoke. These features are shown in FIG. 6, while FIGS. 7 and 8 show additional views of the yoke 170. The dimension values can be varied up to �20%, and preferably up to �10%, of the dimensional values listed in Table 4 below and shown in the Figures. For example, distance A can be about 90-100 mm, distance B can be about 80-100 mm, distance C can be about 25-40 mm, and distance D can be about 45-55 mm, although other distances are possible.
TABLE 4 Yoke Comparison �A� �B� �C� �D� (mm) (mm) (mm) (mm) VISTA � (related art) 130 110 43 48.5 �Small� 1st embodiment - 100 86 28 46 �Mini� �Small� 2nd embodiment - 100 95 37 49 �Kid� �Small 3rd embodiment - 100 90 37 49 �Kidsta-S� Headgear Strap Design
FIG. 9 illustrates a side headgear strap 162 suitable for use with yoke 170 shown in FIG. 6. Strap 162 includes vertical portion 163 and lower portion 164. The yoke is mounted on strap 162 in a manner similar to that shown in relation to the VISTA� yoke and strap, as shown in FIG. 5. For example, the yoke and strap can be secured to one another via stitching, adhesives, etc.
The headgear strap 162 may include the dimensions as shown in FIG. 9. However, those dimension are exemplary only, as other dimensions could be used instead. For example, the strap 162 could have dimensions that are varied up to �20%, but preferably no more than up to �10%, of the dimensional values shown in the example in FIG. 9. Other variations to the yoke are described below, which may also impact the dimensions of the headgear strap.
FIG. 10 shows a center strap 160 for the headgear 150. Preferred dimensions of the center strap 160 are illustrative only, and may be adjusted up to +/−10%-20% of the values shown. FIG. 11 shows the center strap 160 of the �Kid� in side-by-side comparison with the VISTA� center strap. The rear width of the center strap 150 shown in FIG. 10 can be reduced by about 30 mm, as compared to the VISTA� center strap. Further, the center strap 150 can accommodate a label (in label area 161) and ladder locks.
FIGS. 12-16 illustrate a cushion 110 in accordance with an embodiment (e.g., the �Kid�) of the present invention. FIGS. 12-13 and 15 show the cushion mounted on a standard VISTA� frame 120. Cushion 110 includes a double-walled face contacting portion. As shown in FIG. 12, the double wall includes a thin flexible outer membrane 910 which forms a sealing structure, and an underlying rim 920 which forms a support structure. In FIG. 12, the rim 920 is indicated with a broken line as it is seen through and/or below the membrane 910. As shown in FIG. 13, a top view, cushion 110 has a patient contacting region 1110 and a frame-engaging region 1120. The cushion 110 and frame 120 are adapted to engage with one another as in the VISTA� mask, as described in U.S. Patent Application No. 60/402,509, or other ones of the applications listed above, although other engagement methods are possible. Both the membrane 910 and rim 920 preferably include a nasal bridge notch 930, a pair of side portions 940, and a curved lip region 950, as shown in FIG. 12.
The cushion 110 is constructed from a silicone material, such as that used for the VISTA� mask, although other materials could be used, e.g., gel, foam, silicone and combinations thereof.
In accordance with an embodiment of the invention, 2-3 �Kid� cushion sizes and 2-3 �Mini� cushion sizes can be used to fit pre-adults from 2 to 16 years.
Since the �Kid� range of cushions fit adult VISTA� frames, e.g., see frame 120 in FIGS. 2-5, 12, 13 and 15, they have a generally inwardly sloping outer wall 1130 (see FIGS. 13-16) that provides a transition between the relatively smaller patient-contacting region 1110 and the frame-engaging portion 1120 of the cushion 110. The outer wall can also be stepped as well. In either case, the area of the bottom of the cushion (where it connects to the frame) is projected wider than the area where the membrane contacts the facial tissue. The difference in area (i.e., the projected area of the bottom of the cushion) can help reduce the pressure needed to maintain a seal with the face. This is an advantage especially in regard to fitting pre-adult or small adult patients, where the available patient contact area may be limited.
Both the �Kid� and �Mini� range of cushions are not only smaller than adult range of VISTAT� cushions, they have a different shape. For example, both the �Kid� and �Mini� cushions have relatively shallower notches in the nasal bridge region and relatively shallower curves in the lip region compared to an adult VISTA� cushion. See also FIGS. 27, 28, 31, 32 and 34.
Table 5 shows the change in size of a �Kid� cushion in accordance with one embodiment of the invention. The membrane 910 of the cushion 110 has an orifice 975 (FIGS. 12 and 17) defined by the edge 970 of the membrane 910. There is a corresponding orifice 985 (visible through the membrane 910) defined by the edge 980 of the rim 920. In use, the nose of the patient 200 passes through the orifice 975.
As compared to the VISTA� cushion, the orifice 985 of the rim 920 is about 3 mm smaller all around its perimeter, however the membrane 910 is smaller by an amount varying from about 0 to 3 mm. FIG. 17 shows broken line 972 which indicates the general position of the edge of the membrane in a corresponding adult size VISTA� cushion with its corresponding larger orifice. FIG. 18 schematically shows relative changes of the rim of the �Kid� cushion compared to the VISTA� cushion, while FIG. 19 schematically shows relative change in the membrane of the �Kid� compared to the VISTA�. The relative changes in height of the cushion reflect the relatively shallower notch in the nasal bridge region and the relatively shallower curve in the lip region.
�Kid� v. VISTA �+0�Cushion Comparison
nasal bridge region�23
nasal bridge region�35
lip region�31
lip region�33
side region�19
side region�43
nasal bridge region�28
nasal bridge region�14
lip region�20.7
lip region�16
side region�34
side region�26
In accordance with another embodiment of the invention, a �Kid� cushion has a further 3-4 mm increase in height of the membrane in the patient contacting-portion from the frame-engaging portion in the nasal bridge region, hence a total of 9-10 mm when compared to an adult cushion. There is a corresponding change in the rim.
In accordance with another embodiment of the invention, a �Mini� cushion has a further 6-7 mm increase in height of the membrane in the patient contacting-portion from the frame-engaging portion in the nasal bridge region, hence a total of 12-13 mm when compared to an adult cushion. There is a corresponding change in the rim. In this way, a �Mini� cushion has an even shallower notch in the nasal bridge region compared to a �Kid� cushion. Since a �Mini� cushion uses a smaller frame than a �Kid� cushion, it does not have the generally sloping outer wall in the transition region between the face-contacting portion and the frame-engaging portion. Furthermore, the �Mini� cushion is generally closer to the face for better stability. Such a shallower notch is indicated by broken line 990 in FIG. 15. Furthermore, as shown in FIG. 20 the lower corners of the �Mini� cushion 1510 are more rounded (i.e. larger radius) than the corresponding corners of the �Kid� cushion. The cushion includes a nasal ridge region, a top lip region and two side regions. In this example, the membrane and rim each have an orifice in which a width of the membrane orifice is between about 30 and 32 mm in the lip region, between about 18 and 20 mm in each side region, and between about 22 and 24 mm in the nasal bridge region, a width of the rim orifice is about 34 and 36 mm in the nasal bridge region, between about 32 and 34 mm in the lip region, and between about 42 and 44 mm in each side region of the cushion. The membrane and the rim each have a height as measured from a portion of the cushion that engages the frame. The membrane height is about 27 and 35 mm in the nasal bridge region, between about 19 and 22 mm in the lip region, and between about 33-35 mm in each said side region, the rim height is between about 13 and 18 mm in the nasal bridge region and the lip region, and the rim height in each said side portion is between about 25 and 27 mm.
In general the materials used to construct a mask assembly in accordance with the invention are the same as those used to construct the VISTA� mask.
As shown in FIG. 21, there may be some overlap in ages between the different masks and cushions. For example, some pre-adults aged 7 years may find a �Mini� (shown as �Mini-� in FIG. 21) mask too small and it may be appropriate for them to be fitted with a �Kid� (shown as �Kid� in FIG. 19). Of course, the Mini and Kid may be used for adult patients having smaller facial shapes or pre-adult features.
Further cushion embodiments of the invention are described in relation to FIGS. 22-45. These embodiments also relate to shrinking and/or re-proportioning the VISTAT�, Kid or Mini cushion to create �small� (�Kidsta Small�) and �extra small� (�Kidsta Extra-Small (XS)�) cushion sizes, while preferably maintaining the same basic architecture for fitting the cushion to the VISTA� mask frame. The new embodiments have been developed as a result of conducting testing on the �Kid� and �Mini� cushions described above.
The underlying rim 920 should preferably have the same cross section as the VISTA�, e.g., where it attaches to the frame as shown in FIG. 37, while the cross section of the membrane 910 and/or its relationship with the underlying rim 920 should be very similar to the VISTA�, bearing in mind that both should be tweaked at the nasal bridge area 930�the membrane 910 in particular. The cushion height (e.g., the distance measured from the underlying rim 920 (i.e., the upper lip (below the nose) to the top of the cushion as shown in FIG. 22) should be maintained if at all possible the same as the height of the VISTA�, keeping in mind that the height may be affected by having to fit the cushion 110 onto the frame 120.
VISTA �, Kidsta S + Kidsta XS − Cushion
VISTA �
KIDSTA�S
FIG. 25 shows a side view of the �Mini� or �Kid� described above, in use on a pre-adult. As shown, the vertical finger 310 of the yoke 170 may be too close to the user's eyes, and/or the yoke lower finger 330 may impinge on the lower part of the ear lobe. Accordingly, for the Kidsta-S, the dimension �C� from Table 4 can be increased by about 9 mm (i.e., a total of about 37 mm) to move the vertical finger closer to the ear, thereby increasing field of view. To better avoid or help avoid impinging on the lower ear lobe, dimensions �B� and/or �D� from FIG. 6 can be altered, for example, by increasing these dimensions by about 4 mm each, i.e., total dimension �B� would be about 90 mm and total dimension �D� would be about 50 mm (or a bit less than the VISTA�). The lower finger 330 may include a full radius.
The �Kid� or �Mini� can also be better dimensioned and/or shaped to avoid leak at the nasal bridge region, especially for kids under age 11 years old, to avoid intrusion into the eyes, to avoid discomfort stemming from a �hard-edged� cushion, and/or to reduce the size of the cushion, e.g., to avoid dead air space.
The Kid or Mini cushion depth was about 3 mm deeper than the VISTA�, which may introduce possible instability and make headgear difficult to fit. In the Kidsta S, the height is reduced approximately to the height of the VISTA�.
In the Kid or Mini, the radius was smaller across the top lip (compared to the VISTA�) with no leaks or discomfort reported. Thus for the Kidsta S according to the present embodiment, maintain the 2 mm smaller radius compared to the VISTA�. For the Kidsta XS, the radius should be further reduced another 2 mm, in proportion, which may help accommodate patients with smaller lips. See FIG. 26.
VISTA � Standard
FIGS. 28-29 show various other features of the Kidsta S in conjunction with other cushions, for comparison purposes, VISTA� and the Kid or Mini.
FIG. 30 shows the bridge center depth versus cushion type, e.g., of the Kidsta S, Kidsta XS, the Kid or Mini, the VISTA� (S-W) and the VISTA� (Standard). The information in FIG. 30 can be combined with the information in FIG. 27 to select the most appropriate mask given one or more dimensions (and/or the age) of the patient. Compared to the Kid or Mini, the nasal bridge depth is reduced by about 3 mm for the Kidsta S, and 7 mm for the Kidsta XS. Also, the vent is the same as or similar to VISTA�. See FIG. 31.
FIGS. 32-37 show various views of the Kidsta S, while FIGS. 38-42 show various view of the Kidsta XS, including exemplary dimensions. The dimensions can be changed up to about �20%, but preferably no more than up to about �10%, of the exemplary values shown. FIGS. 32-42 are drawn to scale, or at least shown the relative distances between cushion parts to scale.
The headgear clip 140 as shown in the VISTA� (FIGS. 2-5) can be made of PBT, a plastic, resilient material, although other materials can be used. For the present embodiments, the clips can be made of polypropylene, preferably available under the trade name �BOREALIS.� Clips made for polypropylene can be more flexible than PBT, which facilitates operation, e.g., assembly and disassembly, of the clip, especially by pre-adults, e.g., 5 year old girls can operate polypropylene clips. This can help increase compliance of the patient.
The existing VISTA� type frame 120 includes cheek pieces (see FIGS. 2-5) that support the mask both vertically and from side to side movement. These cheek pieces preferably remain in light contact with the cheeks and/or jowls to provide the maximum stability with maximum comfort.
This will make the VISTA� type mask easier to fit onto a variety of different face shapes. Because one mask will fit such a large range, less inventory will be required.
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