# Patent

## Title
Elbow assembly

## Abstract

An elbow assembly for a mask system includes an elbow including a slot and a port, an anti-asphyxia valve adapted to be received within the slot and including a flap portion adapted to selectively close the port depending on the presence of pressurized gas, and a clip member to secure the anti-asphyxia valve to the elbow. The clip member includes a slot that is adapted to interlock with a protrusion provided to the anti-asphyxia valve.

## Background
CROSS-REFERENCE TO APPLICATIONS
This application is a continuation of U.S. Ser. No. 12/308,471, filed Dec. 16, 2008, which is the U.S. national phase of International Application No. PCT/AU2007/000836, filed Jun. 15, 2007, which designated the U.S. and claims the benefit of U.S. Provisional Application Nos. 60/814,055, filed Jun. 16, 2006, and 60/858,699, filed Nov. 14, 2006, each of which is incorporated herein by reference in its entirety.
Also, PCT Application No. PCT/AU2006/000031, filed Jan. 12, 2006, which claims priority to U.S. Provisional Application No. 60/726,699, and PCT Application No. PCT/AU2006/000770, filed Jun. 6, 2006, which claims priority to U.S. Provisional Application Nos. 60/687,453, 60/702,582, and 60/795,562, are each incorporated herein by reference in its entirety.


FIELD OF THE INVENTION
The present invention relates to an elbow assembly for use with a mask assembly used for treatment, e.g., of Sleep Disordered Breathing (SDB) with Continuous Positive Airway Pressure (CPAP) or Non-Invasive Positive Pressure Ventilation (NPPV).
BACKGROUND OF THE INVENTION
A mask assembly typically includes a relatively rigid shell, e.g., a frame, and a patient interface, e.g., a pair of nozzles (which may be in the form of nasal pillows, nasal prongs, cannulae, or nasal puffs) or a cushion (nasal or full-face), that is supported by the rigid shell and structured to deliver pressurized gas to the patient or user in a comfortable, sealed manner. The mask assembly is usually held in place using a headgear assembly.
In some applications, there may be a clinical requirement to provide the mask assembly with one or more safety devices, such as means for CO2 washout, vents, anti-asphyxia valves and the like. In some cases, these additional components are assembled between the gas delivery conduit and the mask assembly. Problems with prior art assemblies may include:
(a) inadvertent assembly without one or more of the safety devices;
(b) incorrect assembly/alignment; and/or
(c) incorrect re-assembly following inadvertent dis-assembly during the course of treatment.
Flow generators typically deliver pressurized breathable gas (air) to a patient wearing the mask assembly. In CPAP treatment, gas is delivered to the patient's airways at about 2-30 cm H2O above atmospheric pressure. The flow generator is generally connected to flexible tubing (air delivery tube) that is secured to the mask assembly worn by the patient. If the flow generator's operation is interrupted as a result of power outage or other mechanical/electrical failure, there may be a significant build up of carbon dioxide in the mask as the patient's exhaled air is not washed out of outlet vents that are usually provided to the mask assembly. This may present a health risk to the patient.
Several patents have addressed this risk, e.g., by use of a safety valve for gas or air delivery mask assemblies. See, e.g., U.S. Pat. No. 3,796,216 to Schwarz, and U.S. Pat. No. 5,438,981 to Starr et al., as well as PCT international application No. PCT/AU97/00849.
SUMMARY OF THE INVENTION
One aspect of the present invention relates to an elbow assembly for a mask system including an elbow including a slot and a port, an anti-asphyxia valve adapted to be received within the slot and including a flap portion adapted to selectively close the port depending on the presence of pressurized gas, and a clip member to secure the anti-asphyxia valve to the elbow. The clip member includes a slot that is adapted to interlock with a protrusion provided to the anti-asphyxia valve. The clip member includes wings. The wings are structured such that the wings protrude outwardly from the elbow when the clip member is secured to the elbow.
Another aspect of the present invention relates to an elbow assembly for a mask system including an elbow including a slot and a port, an anti-asphyxia valve adapted to be received within the slot and including a flap portion adapted to selectively close the port depending on the presence of pressurized gas, and a clip member to secure the anti-asphyxia valve to the elbow. The clip member includes a slot that is adapted to interlock with a protrusion provided to the anti-asphyxia valve. The slot of the clip member is sized to prevent assembly of the flap portion of the anti-asphyxia valve through the slot of the clip member.
Another aspect of the present invention relates to an elbow assembly for a mask system. The elbow assembly includes an elbow including a slot and a port, an anti-asphyxia valve adapted to be received within the slot and including a flap portion adapted to selectively close the port depending on the presence of pressurized gas, and a clip member to secure the anti-asphyxia valve to the elbow. The clip member includes a slot that is adapted to interlock with a protrusion provided to the anti-asphyxia valve. The clip member includes one or more portions that have a textured or frosted surface.
It will of course be understood that the structural and/or functional features of the present invention may be usefully employed in full facial masks or nasal masks or nasal prongs, nozzles, nare seals, and/or cannulae.
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.



BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings facilitate an understanding of the various embodiments of this invention. In such drawings:
FIG. 1 shows an exemplary embodiment of a full facial mask assembly;
FIGS. 2-1 to 2-8 show various views of an elbow assembly according to an embodiment of the present invention;
FIGS. 3-1 to 3-6 show various views of an elbow of the elbow assembly shown in FIGS. 2-1 to 2-8;
FIGS. 4-1 to 4-10 show various views of a clip member of the elbow assembly shown in FIGS. 2-1 to 2-8;
FIGS. 5-1 to 5-9 show various views of an elbow assembly according to another embodiment of the present invention;
FIGS. 6-1 to 6-8 show various views of an elbow of the elbow assembly shown in FIGS. 5-1 to 5-9;
FIGS. 7-1 to 7-8 show various views of a clip member of the elbow assembly shown in FIGS. 5-1 to 5-9;
FIGS. 8-1 to 8-7 show various views of an anti-asphyxia valve (AAV) according to an embodiment of the present invention;
FIG. 9 shows an anti-asphyxia valve (AAV) attached to a clip member according to another embodiment of the present invention; and
FIGS. 10-1 to 10-7 show various views of a clip member according to another embodiment of the present invention.



DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS
FIG. 1 illustrates an exemplary embodiment of a full facial mask assembly (“FMA”) 10. As illustrated, the mask assembly 10 includes a frame 14, a cushion 16 provided to the frame 14 and adapted to form a seal with the patient's face, an elbow assembly 18 provided to the frame 14 and adapted to be connected to an air delivery tube that delivers breathable gas to the patient, and a forehead support 12 to provide a support and stability mechanism between the mask assembly 10 and the patient's forehead. A headgear assembly (not shown) may be removably attached to the frame 14 (e.g., via headgear clips) and the forehead support 12 to maintain the mask assembly 10 in a desired adjusted position on the patient's face.
Further details and embodiments of such mask assemblies are disclosed in PCT Application No. PCT/AU2006/000031, the entirety incorporated herein by reference.
1. First Illustrated Embodiment of Elbow Assembly
FIGS. 2-1 to 2-8 illustrate an elbow assembly 218 according to an embodiment of the present invention. In the illustrated embodiment, the elbow assembly 218 is adapted for use with a mask assembly of the type described above in FIG. 1. However, the elbow assembly 218 may be implemented into other mask systems, e.g., full-face mask, mouth mask, or a nasal mask.
The main components of the elbow assembly 218 are an elbow 230 (see FIGS. 3-1 to 3-6), an anti-asphyxia valve (AAV) 250 (see FIGS. 8-1 to 8-7), and a clip member 270 (see FIGS. 4-1 to 4-10) to secure the AAV 250 to the elbow 230. It is noted that the AAV 250 is a common component that may be used in the elbow assembly 218 as well as an elbow assembly 318 described in greater detail below.
1.1 Elbow
As shown in FIGS. 3-1 to 3-6, the elbow 230 includes a first portion 232 provided to a mask frame and a second portion 234 provided to a swivel joint connected to an air delivery tube. The first portion 232 includes snap-fit tabs 233, e.g., six tabs, to connect the first portion 232 to the mask frame with a snap-fit. However, more or less snap-fit tabs may be used, e.g., 2-10 tabs.
The second portion 234 includes snap-fit tabs 235, e.g., six tabs, to connect the second portion 234 to the swivel joint. The snap-fit diameter at the second portion 234 may be smaller than the snap-fit diameter at the first portion 232 to prevent incorrect assembly. Annular rings 236, e.g., three rings, are provided on the second portion 234 for improved seal with the swivel joint and improved manufacturability.
The elbow 230 also includes a slot 238 to receive the AAV 250, a port 240 that is selectively closed by the flap portion 252 of the AAV (depending on the presence of pressurized gas), and two tabs 242 for attaching the clip member 270 with a snap-fit. As illustrated, the port 240 has a central rib 241 to prevent small objects from falling in or being placed in the port 240 and thereby affecting AAV function.
As best shown in FIG. 2-8, the elbow 230 has a relatively thin cross-section and includes a seat 244 upon which the AAV 250 can sit. The seat 244 prevents over-deflection of the flap portion 252 of the AAV 250, e.g., prevents the flap portion 252 from deflecting too far towards the second portion 234 of the elbow 230. In addition, the seat 244 prevents edges of the flap portion 252 from getting caught in the elbow 230, e.g., prevents edges of the flap portion 252 from getting caught against rough surfaces or flash in the elbow 230.
1.2 Clip Member
As shown in FIGS. 2-1 to 2-8, 4-1 to 4-10, and 8-1 to 8-7, the clip member 270 interlocks with the AAV 250 to provide a sub-assembly that is removably attached to the elbow 230 with a snap-fit. Specifically, the AAV 250, e.g., constructed of flexible silicone or other elastic material, includes an arrowhead-shaped protrusion 254 that removably interlocks with a slot 272 provided on the clip member 270, e.g., constructed of rigid plastic. The inside edges of the slot 272 may have a filleted, curved, chamfered, or tapered configuration to facilitate assembly of the AAV 250.
Also, the slot 272 of the clip member 270 and the protrusion 254 on the AAV 250 are relatively narrow to prevent mis-assembly, e.g., the flap portion 252 of the AAV 250 cannot be assembled through the slot 272.
The clip member 270 includes two recesses 274 that interlock with respective tabs 242 provided to the elbow 230. As shown in FIGS. 2-1 to 2-8, the elbow 230 is structured such that, when the clip member 270 is attached to the elbow 230, the clip member 270 includes portions that are substantially flush with a surface surrounding the port 240.
The clip member 270 includes extended edges or wings 276 that protrude outwardly from the elbow 230 when assembled thereto. The wings 276 provide easy location and removal of the clip member 270 on disassembly. In addition, the wings 276 provide a lead-in for press-fitting the clip member 270 on assembly.
The clip member 270 includes a central vertical rib 278. As illustrated, the rib 278 has an extended height and a contour that substantially matches an outer surface 246 of the elbow. The rib 278 prevents assembly of the clip member 270 if the flap portion 252 of the AAV 250 gets caught against the elbow 230 on assembly. Specifically, when the clip member 270 is assembled to the elbow 230, the rib 278 is located against the elbow outer surface 246, e.g., flush against the elbow outer surface, to prevent the AAV 250 from being assembled between the clip member 270 and the elbow 230. For example, if the clip member 270 is assembled to the elbow 230 with the AAV 230 in an incorrect orientation (e.g., the flap portion 252 of the AAV 250 positioned between the rib 278 and the elbow outer surface 246), the rib 278 prevents the clip member 270 from interlocking with the elbow 230. It would then be evident to a user that the AAV had not been correctly installed.
The rib 278 may also prevent the clip member 270 from being assembled to other elbow embodiments, e.g., the elbow 330 described below.
In an embodiment, the clip member 270 has a thickness of about 1.5 mm. However, other thicknesses are possible.
2. Second Illustrated Embodiment of Elbow Assembly
FIGS. 5-1 to 5-9 illustrate an elbow assembly 318 according to another embodiment of the present invention. In the illustrated embodiment, the elbow assembly 318 is adapted for use with a nasal mask system of the type described in PCT Application No. PCT/AU2006/000770, filed Jun. 6, 2006, which claims priority to U.S. Provisional Application Nos. 60/687,453, 60/702,582, and 60/795,562, and PCT Application No. PCT/AU04/01832, filed Dec. 24, 2004, which are each incorporated herein by reference in its entirety. However, the elbow assembly 318 may be implemented into other mask systems, e.g., full-face mask, mouth mask, or a nasal mask.
The main components of the elbow assembly 318 are an elbow 330 (see FIGS. 6-1 to 6-8), an anti-asphyxia valve (AAV) 250 (see FIGS. 8-1 to 8-7), and a clip member 370 to secure the AAV 250 to the elbow 330 (see FIGS. 7-1 to 7-8). As noted above, the AAV 250 is a common component that may be used in both elbow assemblies 218, 318.
2.1 Elbow
As shown in FIGS. 6-1 to 6-8, the elbow 330 includes a first portion 332 connectable to a mask frame and a second portion 334 connectable to an air delivery tube. The first portion 332 of the elbow 330 is releasably connected to a flanged collar member provided to the mask frame in a snap-fit manner as is known from U.S. Patent Application Publication No. 2003/0196656, which is incorporated herein by reference in its entirety.
The elbow 330 also includes a slot 338 to receive the AAV 250, a port 340 that is selectively closed by the flap portion 252 of the AAV 250 (depending on the presence of pressurized gas), and two retaining features 342, e.g., recesses or protrusions, for attaching the clip member 370 with a snap-fit. As illustrated, the port 340 has a central rib 341 to prevent small objects from falling in or being placed in the port 340 and thereby affecting AAV function.
2.2 Clip Member
As shown in FIGS. 5-1 to 5-9, 7-1 to 7-8, and 8-1 to 8-7, the clip member 370 interlocks with the AAV 250 to provide a sub-assembly that is removably attached to the elbow 330 with a snap-fit. Specifically, the AAV 250, e.g., constructed of flexible silicone or other elastic material, includes an arrowhead-shaped protrusion 254 that removably interlocks with a slot 372 provided on the clip member 370, e.g., constructed of rigid plastic. The inside edges of the slot 372 may have a filleted, curved, chamfered, or tapered configuration to facilitate assembly of the AAV 250.
Also, the slot 372 of the clip member 370 and the protrusion 254 on the AAV 250 are relatively narrow to prevent mis-assembly, e.g., the flap portion 252 of the AAV 250 cannot be assembled through the slot 372.
The clip member 370 includes two tabs 374 that interlock with respective retaining features 342 provided to the elbow 330. The clip member 370 also includes slightly extended edges 376. The edges 376 provide easy location and removal of the clip member 370 on disassembly.
Also, the clip member 370 has a relatively thin cross-section to allow easier deflection as the clip member 370 is removed by un-wrapping the clip member 370 from the elbow 330. In an embodiment, the clip member 370 has a thickness of about 1.35 mm. However, other thicknesses are possible.
In addition, the clip member 370 includes recessed sides 380 and a central vertical rib 378 integrally molded with the clip member 370. When the clip member 370 is assembled to the elbow 330, the recessed sides 380 and central vertical rib 378 are located against the elbow outer surface 346, e.g., flush against the elbow outer surface, to prevent the AAV 250 from being assembled between the clip member 370 and the elbow 330.
3. AAV
FIGS. 8-1 to 8-7 illustrate the AAV 250 that may be used with either elbow assembly 218, 318. As explained above, the AAV 250 includes an arrowhead-shaped protrusion 254 that removably interlocks with a slot 272, 372 provided on the clip member 270, 370 and a flap portion 252 that selectively closes an elbow port 240, 340 (depending on the presence of pressurized gas).
FIG. 9 illustrates an alternative embodiment of an AAV 450 attached to the clip member 270 shown in FIGS. 4-1 to 4-10. As illustrated, the flap portion 452 of the AAV 450 includes an arrangement of protrusions and/or grooves 460 on its face.
4. Alternative Embodiment of Clip Member
FIGS. 10-1 to 10-7 illustrate a clip member 570 to secure an AAV to an elbow according to another embodiment of the present invention. The clip member 570 is similar to the clip member 270 described above. In contrast, the clip member 570 includes one or more portions that have a textured or frosted surface.
As illustrated, the clip member 570 includes a main body 571 and extended edges or wings 576 that protrude outwardly from the main body 571. Similar to clip 270, the clip member 570 includes a slot 572 adapted to removably interlock with an AAV, two recesses 574 adapted to removably interlock with an elbow, and a central vertical rib 578 to prevent misassembly of the clip member 570 to an elbow.
In the illustrated embodiment, the clip member 570 includes a textured or frosted surface below a parting line P (see FIG. 10-1). Specifically, a lower portion of the main body 571 and the wings 576 have a textured or frosted surface. The area including the textured or frosted surface is identified in darker outline in FIGS. 10-1 to 10-4 and 10-6 to 10-7. As illustrated, the textured or frosted surface is provided to portions of the clip member 570 that face outwardly from the elbow when the clip member 570 is assembled thereto.
The textured or frosted surface is provided to improve grip of the clip member 570 during assembly and disassembly with respect to the elbow. The textured or frosted surface also hides marks or imperfections on the clip member 570 caused during manufacturing, e.g., injection molding gate marks, to improve aesthetics. In an embodiment, the textured or frosted surface may include any suitable surface treatment or surface roughening/scoring that improves grip.
It should be appreciated that the textured or frosted surface may be provided to any suitable portion of the clip member 570. Also, a textured or frosted surface may be provided to other embodiments of a clip member, e.g., clip member 370.
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, barriatric surgery, etc.) can derive benefit from the above teachings. Moreover, the above teachings have applicability with patients and non-patients alike.

## Claims

1. An elbow assembly for a mask system, comprising:
an elbow including a first slot and a port;
an anti-asphyxia valve adapted to be received within the first slot and including a flap portion adapted to selectively close the port depending on the presence of pressurized gas; and
a clip member configured to secure the anti-asphyxia valve to the elbow, the clip member including an alignment portion configured to prevent assembly of the anti-asphyxia valve, elbow and clip member when the anti-asphyxia valve is misaligned with respect to the clip or improperly oriented with respect to the clip.

2. The elbow assembly of claim 1, wherein the alignment portion comprises a projection member positioned so that the clip member cannot be secured to the elbow when the flap portion of the anti-asphyxia valve is between the elbow and the clip member.

3. The elbow assembly of claim 2, wherein the alignment portion comprises a second slot configured to receive a portion of the anti-asphyxia valve, the second slot being sized so that the flap portion cannot be inserted through the second slot.

4. The elbow assembly of claim 3, wherein the anti-asphyxia valve comprises a protrusion member configured to be inserted through the second slot.

5. The elbow assembly of claim 4, wherein the protrusion member is configured to be secured to a periphery of the second slot by a snap-fit connection.

6. The elbow assembly of claim 5, wherein the clip member includes a sub-assembly configured to secure the clip member to the elbow by a snap-fit connection.

7. The elbow assembly according to claim 1, wherein the elbow includes snap-fit tabs adapted to connect the elbow to a mask frame.

8. The elbow assembly according to claim 1, wherein the elbow includes snap-fit tabs adapted to connect the elbow to a swivel joint.

9. A mask assembly configured to deliver pressurized gas to a patient, the mask assembly comprising:
a frame;
a cushion provided to the frame and adapted to form a seal with the patient's face; and
an elbow assembly according to claim 1.

10. The mask assembly of claim 9, wherein the elbow assembly is adapted to be connected to an air delivery tube.

11. The mask assembly of claim 10, wherein the elbow of the elbow assembly includes snap-fit tabs adapted to connect the elbow to the frame.

12. The mask assembly of claim 11, wherein the elbow includes snap-fit tabs adapted to connect the elbow to a swivel joint.

13. An elbow assembly for a mask system, comprising:
an elbow including a first slot and a port;
an anti-asphyxia valve adapted to be received within the first slot and including a flap portion adapted to selectively close the port depending on the presence of pressurized gas; and
clip member with a vertical rib configured to abut an outer surface of the elbow when the anti-asphyxia valve is properly aligned and oriented, the vertical rib being prevented from abutting the outer surface of the elbow when the anti-asphyxia valve is misaligned and/or incorrectly oriented.

14. The elbow assembly of claim 13, wherein the clip member includes a second slot that is adapted to interlock with a protrusion provided to the anti-asphyxia valve.

15. The elbow assembly of claim 14, wherein the protrusion extends through the second slot when the protrusion is interlocked with the clip member so that the protrusion is visible from outside the elbow when the clip member is secured to the elbow.

16. The elbow assembly of claim 15, wherein clip member is configured to be removably secured to the anti-asphyxia valve and to be removably secured to the elbow.

17. The elbow assembly of claim 16, wherein the second slot is sized to prevent assembly of the flap portion of the anti-asphyxia valve through the second slot.

18. The elbow assembly according to claim 17, wherein the port has a central rib.

19. The elbow assembly according to claim 18, wherein the elbow includes a seat upon which the AAV is adapted to sit, the seat structured to prevent over-deflection of the flap portion in use.

20. A mask assembly configured to deliver pressurized gas to a patient, the mask assembly comprising:
a frame;
a cushion provided to the frame and adapted to form a seal with the patient's face; and
an elbow assembly according to claim 13.

21. The mask assembly of claim 20, wherein the elbow assembly is adapted to be connected to an air delivery tube.

22. The mask assembly of claim 21, wherein the elbow of the elbow assembly includes snap-fit tabs adapted to connect the elbow to the frame.

23. The mask assembly of claim 22, wherein the elbow includes snap-fit tabs adapted to connect the elbow to a swivel joint.