INTERCHANGEABLE MASK ASSEMBLY
20210316101 · 2021-10-14
Inventors
- Eva Ng (Sydney, AU)
- Robert Edward Henry (Sydney, AU)
- Philip Rodney Kwok (Sydney, AU)
- Karthikeyan Selvarajan (Sydney, AU)
Cpc classification
A61M16/0616
HUMAN NECESSITIES
Y10T29/49826
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
A61M16/0605
HUMAN NECESSITIES
International classification
Abstract
A system of breathing arrangements for delivering breathable gas to a patient includes at least first and second cushion components, e.g., full-face, nasal, nasal prongs, nose tip, and/or a combination of any of the above, including a nasal or full-face cushion and nasal prongs/nozzles combination, etc., that are different from one another in at least one aspect, and a common frame assembly configured to support each of the first and second cushion components. Various embodiments are directed to a full-face or nasal mask used with a frame having lateral connector portions having a stiffening member. The mask assembly may include a nose height adjustment device for the height of the cushion, or a cushion adjustment member by which the position of the cushion may be adjusted relative to the frame. The mask assembly may include a chin strap assembly.
Claims
1.-20. (canceled)
21. A respiratory mask assembly for providing respiratory therapy to a patient, the respiratory mask assembly comprising: a main body; a cushion component including a sealing portion, wherein the sealing portion is constructed and arranged to form a seal with a patient's nose; a cushion retainer configured to releasably couple the cushion component to the main body, wherein the cushion retainer is relatively harder than the cushion component, wherein the cushion retainer includes a cushion retainer part structured and arranged to engage behind a retainer part provided to the main body to releasably couple the cushion retainer to the main body, wherein the cushion component and the cushion retainer form at least a portion of a breathing chamber pressurizable to a therapeutic pressure, wherein the cushion retainer includes an opening structured to receive a flow of air at the therapeutic pressure for breathing by the patient, and wherein the cushion retainer is configured to releasably couple the cushion component to the main body while allowing the flow of air to the cushion component; a gas washout vent configured to releasably couple with the main body, the gas washout vent configured to washout gas from the breathing chamber to ambient atmosphere; headgear to maintain the respiratory mask assembly in position on a patient's head, the headgear including upper side straps and lower side straps; and a pair of lower headgear connectors, each of the pair of lower headgear connectors configured to connect a respective one of the lower side straps to the main body.
22. The respiratory mask assembly according to claim 21, further comprising a pair of upper lateral members provided to the main body, each of the pair of upper lateral members including a respective one of a pair of upper headgear connectors, and the upper side straps are adapted to connect to a respective of the pair of upper headgear connectors.
23. The respiratory mask assembly according to claim 21, wherein the main body includes a lower opening having a closed shape and an upper opening having a closed shape that is spaced apart and superior to the lower opening.
24. The respiratory mask assembly according to claim 23, wherein the lower opening is configured to communicate with the gas washout vent when the gas washout vent is releasably coupled with the main body.
25. The respiratory mask assembly according to claim 23, wherein the upper opening is configured to receive the cushion retainer when the cushion retainer is releasably coupled with the main body.
26. The respiratory mask assembly according to claim 21, wherein the cushion retainer includes an inside surface exposed to said therapeutic pressure in use.
27. The respiratory mask assembly according to claim 21, further comprising an elbow structured to connect to a respiratory gas conduit to deliver the flow of air at the therapeutic pressure to the breathing chamber.
28. The respiratory mask assembly according to claim 21, wherein the cushion retainer comprises polycarbonate and the cushion component comprises silicone.
29. The respiratory mask assembly according to claim 21, wherein the cushion retainer part forms a space to receive the retainer part of the main body when the cushion retainer is releasably coupled with the main body.
30. A CPAP system for providing respiratory therapy to a patient, the CPAP system comprising: the respiratory mask assembly according to claim 21; a blower to supply a flow of air at a therapeutic pressure; and a conduit to pass the flow of air at the therapeutic pressure from the blower to the respiratory mask assembly.
31. A respiratory mask assembly for providing respiratory therapy to a patient, the respiratory mask assembly comprising: a main body including lateral sides, each of the lateral sides of the main body including an opening structured to receive a flow of air at a therapeutic pressure for breathing by the patient; a cushion component including a sealing portion, wherein the sealing portion is constructed and arranged to form a seal with a patient's nose; a cushion retainer configured to releasably couple the cushion component to the main body; headgear to maintain the respiratory mask assembly in position on a patient's head, the headgear including side straps; a pair of inlet conduits structured to deliver breathable gas into the respiratory mask assembly for breathing by the patient, each of the pair of inlet conduits provided to a respective one of the lateral sides of the main body; and a pair of connectors configured to releasably couple the pair of inlet conduits to a respective opening of the main body.
32. The respiratory mask assembly according to claim 31, wherein the cushion retainer is in the form of a clip element.
33. The respiratory mask assembly according to claim 31, wherein the cushion retainer includes a cushion retainer part structured and arranged to engage behind a retainer part provided to the main body to releasably couple the cushion retainer to the main body.
34. The respiratory mask assembly according to claim 31, wherein the side straps are connected to a respective one of a pair of headgear connectors, each of the pair of headgear connectors provided to a respective one of the pair of connectors.
35. The respiratory mask assembly according to claim 31, further comprising a gas washout vent provided to the main body for washout gas.
36. A CPAP system for providing respiratory therapy to a patient, the CPAP system comprising: the respiratory mask assembly according to claim 31; a blower to supply a flow of air at a therapeutic pressure; and a conduit to pass the flow of air at the therapeutic pressure from the blower to the respiratory mask assembly.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] Preferred embodiments of the invention will be described in relation to the following figures, in which:
[0016]
[0017]
[0018]
[0019]
[0020]
[0021]
[0022]
[0023]
[0024]
[0025]
[0026]
[0027]
DETAILED DESCRIPTION OF EMBODIMENTS
[0028] The following description is provided in relation to several embodiments which may share common characteristics and/or features. It is understood that one or more features of any one embodiment may be combinable with one or more features of the other embodiments which combinations form additional embodiments.
1.0 First Embodiment—Common Frame with Activa™ or UltraMirage™ Cushion Component
[0029]
[0030] The common frame 10 has a main body 40 defining a central opening 45. Main body 40 includes at least two lateral arms 50, each of which can be coupled to a headgear strap 55 of headgear. The straps may be connected to the frame using a press-fit connector 60, as is known in the art. Common frame 10 may also include a forehead support 65 that has a bridge 70 provided with forehead pads 75 to rest against the user's forehead in use. Forehead support may be adjustably mounted to the common frame, in a manner known in the art.
[0031] Common frame 10 is configured to be selectively coupled to one of cushion components 15, 20 and to one of elbow components 25, 30. Cushion components 15, 20 differ in at least one respect such that one may be more optimal or preferable for use with one user, while another may be more suitable or preferably for use with another user. For example, cushion component 15 may be an Activa™ component, while cushion component 20 may be an UltraMirage™ Series II cushion component, both available from ResMed. These cushion components can be significantly different from one another, e.g., the Activa™ includes a gusset portion 80 and a cushion clip assembly (not shown) which is not incorporated in the UltraMirage™ cushion design.
[0032] Common frame 10 is also configured for use with either elbow component 25, or elbow component 30. Elbow components differ in at least one respect, e.g., each may include gas washout vents that are configured for predetermined washout rates, noise, etc.
[0033] Common frame 10 is advantageous since it works with a plurality of different cushion components, elbow components, forehead supports, etc., thereby eliminating the need to specifically make the frame for a particular peripheral component, as is the standard.
2.0 Second Embodiment—Common SWIFT™ Frame with VISTA™ Cushion Component—Below the Nose
[0034]
[0035] Common frame is similar to ResMed's SWIFT™ frame, described in more detail in relation to U.S. patent application Ser. No. 10/781,929, filed Feb. 20, 2004, incorporated herein by reference in its entirety. As shown in
[0036]
[0037] Cushion component 100 includes lateral sides 160 configured to engage with corresponding channels 165 formed in the frame 95. Cushion component 100 includes an aperture 196 (schematically illustrated) to receive the user's nose. End portions 170 of cushion component 100 are wrapped around frame 95, and clip element 175 is attached to the sub-assembly of the cushion component and the frame, by sliding the clip element over the combined cushion component and frame.
[0038]
[0039] In the embodiment described above, the cushion component 100 is bisected (see
[0040] Further, cushion component 100 has an upper portion 200 that is configured to contact the transition between the bony and cartilage portions of the user's nose. Generally, with regard to its footprint, the cushion component is similar to ResMed's VISTA™ cushion, as described in U.S. patent application Ser. No. 11/124,251, filed May 9, 2005, incorporated herein by reference.
[0041] Cushion component 100 has a thickened portion 205 that acts as a pseudo or “soft” frame to provide support for the rest of the membrane of the cushion. Effectively, the thickened portion 205 of the cushion enlarges the “frame” area of the common Swift™ frame. In this example, the thickened portion 205 has the shape of a semi-circle or trapezoid. See, e.g.,
[0042] Common headgear assembly 105 is similar to the headgear assembly described in relation to ResMed's U.S. patent application Ser. No. 10/781,929. However, common headgear 105 has some differences. For example, as shown in
[0043] In
3.0 Third Embodiment—Common Swift™ Frame with Mirage™ Cushion Component
[0044]
[0045] The cushion component 250 may include a thickened section 255 in order to help prevent flopping of the cushion away from the user's face. The thickened section 255 may include a cutout 260 in each corner to reduce force on the nasal bridge region.
4.0 Fourth Embodiment—Common Swift™ Frame with Vista™ Cushion Component—Over the Nose
[0046]
5.0 Fifth Embodiment—Vista/Swift Prongs Combination
[0047]
[0048] The supplemental cushion 320 includes at least one hole 325 provided on its lateral side for insertion over the frame/cushion assembly 310. Supplemental cushion 320 also includes a centrally located hole 330 that aligns with the gas washout vents 335 of the frame/cushion assembly 310.
[0049] To assemble the supplemental cushion over the frame, each hole 325 of the supplemental cushion 320 is stretched over the connector of the frame, and the resiliency of the material of the supplemental cushion allows it to engage with the channels of the frame and/or to simply seal with an exposed surface of the frame cushion assembly. In this position, the prongs 315 seal with the nares, while the supplemental cushion includes a face contacting portion that seals with the user' face.
6.0 Additional Embodiments
[0050] As can be determined from the description above in relation to the embodiments of
6.1 Locked Elbow
[0051] Furthermore, there are additional factors that may be considered when combining the various mask systems. For example, the force due to air pressure against the cushion may cause moments about the elbow. If these moments are not counteracted, the result may be the cushion rotating and losing seal. The elbow should be stiff enough to prevent rotation under pressure. A locking or ratcheting mechanism may be implemented to lock the rotation on the elbow when the desired angle is found. Locking may be achieved using an interference fit, and/or locking components, such as detents or a pin/groove arrangement. Generally, an approximation of the desired effect can be achieved by simply fixing the elbow in place relative to the frame. Otherwise, simply inhibiting rotation, e.g., by strapping the elbow to the adjacent headgear, can be effective as well.
6.2 Stiffening Member For Cushion Component
[0052] When the cushion is under pressure, moments about the cushion to frame interface are created. The force vector points which cause the moments may be shifted by introducing a non-flexible or stiffening member to the cushion. That is to say, in addition to having a moment about the elbow, there is also a moment about the interface of the stiff section of the cushion and the flexible part of the cushion.
6.2.1 Stiffening Ribs
[0053] The mask assembly 340 in
[0054] The mask assembly 360 in
6.2.2 Thickened Cushion Portion
[0055] The stiffening member may take the form of one or more thickened elements, e.g., by thickening the cushion which will result in it being stiffer in sections. See, e.g., the relatively thickened portion of cushion component in
6.3 Nose Tip Cushion Component
[0056]
6.4 Full-Face Cushion
[0057]
[0058] The cushion 420 may include a rib 425 that extends from the bottom to the top of the cushion. Furthermore, the frame 415 is positioned on the upper ½ to upper ⅓ of the cushion to support the cushion. The frame to cushion interface is positioned below the nose, although it may be above the nose. The cushion may include one or more gas washout vents 430.
7.0 Adjustable Positioning of the Cushion
7.1 Adjustable Nose Height
[0059]
[0060] The upper part 460 of the cushion may include a thin membrane (the lower cushion may be like a double wall Vista™ cushion). This has the advantage of reduced weight and subjectively feels light to wear. It may also allow deflection around contours of nose as it will be more flexible than a conventional thick cushion. This will help with fit and the range of patients suited to each size.
[0061] In an alternative, the upper part 460 of the cushion shown in
[0062] The lower part of the cushion 465 may include a gusset portion, a double gusset, or a solid silicon structure.
7.2 Adjustable Cushion Height
[0063] As described above, the position of the centroid of the cushion to frame interface (frame clip location) may be changed, depending on application. The closer the headgear vectors act to the centroid of the cushion the more stable the cushion will be on the face of the patient; this can reduce the rigidity required within the cushion to maintain support of the membrane. The frame location in
[0064] However, it is also possible to change the position of the cushion relative to the face and frame, while maintaining the frame in a constant position. The mask assembly 500 in
[0065] In
[0066] Alternatively, the headgear and frame angle may rotate around the same cushion position. As a further alternative the headgear location point could be on a lobe or cam to move it relative to the cushion. A further embodiment is the use of weight to change the center of gravity of the cushion or frame/headgear system.
8.0 Chin Strap
[0067]
[0068] Chin strap assembly 620 includes an extender 625 and chin strap 630. Extender 625 is shown in
[0069] Chin strap 630 includes a cushion sealing area 650, and is made from a foamed headgear material. The chin strap is preferably elastic. Chin strap is bonded to the frame at a bond point or region 655, e.g., as shown in
[0070] Another variant is to simply use only the extender and chin strap shown in
[0071] A further embodiment is the combination the full-face seal as shown in
[0072] 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. 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 in non-medical applications.