The present invention relates to a mask for delivery of respiratory therapy to a patient. Examples of such therapies are Continuous Positive Airway Pressure (CPAP) treatment, Non-Invasive Positive Pressure Ventilation (NIPPV), and Variable Positive Airway Pressure (VPAP). The therapy is used for treatment of various respiratory conditions including Sleep Disordered Breathing (SDB) such as Obstructive Sleep Apnea (OSA).
A known mask is commercially sold under the name of HYBRID™ by Respcare, Inc. and one or more portions of the mask are described in U.S. Patent Publication No. 2006/0124131, published Jun. 15, 2006, and/or at the website www.hybrid-mask.com.
One aspect of the present invention relates to improvements and/or alternative arrangements of HYBRID™ mask to enhance respiratory therapy.
Another aspect of the invention relates to a mask including a frame, a facial and nasal interface provided to the frame, and headgear provided to the frame to maintain the mask in a desired position on the patient's face. The headgear includes at least one strap and a buckle provided to the strap. The buckle includes an opening adapted to engage a post provided on the frame. The opening and/or the post includes a keyed portion structured to prevent rotation of the buckle with respect to the post when the buckle is engaged with the post.
Another aspect of the invention relates to a mask including a frame, a facial and nasal interface provided to the frame, and a lotion dispenser or moisturizer provided to frame and adapted to dispense lotion for lubricating and/or moisturizing the facial and/or nasal interface.
Another aspect of the invention relates to a mask including a frame, a cushion provided to the frame and adapted to form a seal around an exterior of the patient's mouth in use, and nasal prongs provided to the cushion and adapted to from a seal with the patient's nasal passages in use. Each of the nasal prongs is adapted to rotate relative to the cushion to change the angle at which the nasal prong extends with respect to the cushion.
Another aspect of the invention relates to a mask including a frame, a cushion provided to the frame and adapted to form a seal around an exterior of the patient's mouth in use, and a chin portion or chin flap provided to the cushion and adapted to engage the patient's chin in use. The chin portion or chin flap includes a bellows arrangement structured to allow movement of the patient's chin in use.
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 the invention.
The accompanying drawings facilitate an understanding of the various embodiments of this invention. In such drawings:
The following includes descriptions of several illustrated embodiments of the present invention, which may share common characteristics and features. It is to be understood that one or more features of any one embodiment may be combinable with one or more features of the other embodiments. In addition, each single feature or combination of features in any of the embodiments may constitute an additional embodiment.
Each illustrated embodiment includes features that may be adapted for use and/or incorporated into the embodiments and/or components of the HYBRID™ mask, the mask described in U.S. Patent Publication No. 2006/0124131, published Jun. 15, 2006, and/or at the website www.hybrid-mask.com, as would be apparent to those of ordinary skill in the art. The HYBRID™ mask, U.S. Patent Publication No. 2006/0124131, and the website www.hybrid-mask.com are each incorporated herein by reference in its entirety.
While each illustrated embodiment is described as being implemented into a HYBRID™ mask, a mask of the type described in U.S. Patent Publication No. 2006/0124131, and/or a mask of the type described at the website www.hybrid-mask.com, each illustrated embodiment may be implemented into other masks, e.g., full-face mask, mouth mask, nasal mask, nasal prongs, nozzles, nare seals, and/or cannulae.
The following embodiments describe improvements and/or alternative arrangements of the HYBRID™ mask to enhance respiratory therapy.
The headgear 20 of the HYBRID™ mask is constructed of a soft, flexible material and includes upper side straps 22 that pass over the patient's ear's, lower side straps 24 that pass below the patient's ear's, a Velcro® adjustable overhead strap 26 that passes over the top of the patient's head, and upper and lower rear straps 28, 29 that pass behind the patient's head and neck (e.g., see
In an alternative embodiment, as shown in
Exemplary embodiments of such a rigid element provided to a headgear strap is disclosed in U.S. Pat. No. 6,907,882 and U.S. application Ser. No. 10/781,929, filed Feb. 20, 2004, each of which is incorporated herein by reference in its entirety.
In an alternative embodiment, as shown in
An exemplary embodiment of such headgear is disclosed in PCT Application No. PCT/AU2006/000770, filed Jun. 6, 2006, which is incorporated herein by reference in its entirety.
In an alternative embodiment, the lower rear strap 29 (see
An exemplary embodiment of such lower strap arrangement is disclosed in U.S. patent application Ser. No. 10/433,779, filed Nov. 13, 2003, which is incorporated herein by reference in its entirety.
In an alternative embodiment, one or more of the headgear straps may be constructed of a more elastic material, e.g., the upper and/or lower side straps 22, 24.
In another alternative embodiment, Velcro® joints may be incorporated into one or more straps of the headgear 20 so that different parts of the headgear 20 could be aligned in different ways. For example, Velcro® joints 31 may be incorporated into the upper and/or lower rear straps 28, 29 to allow adjustment of the length and/or angle of the upper and/or lower rear straps 28, 29 as shown in
In another alternative embodiment, the upper side straps 22 and/or the upper rear strap 28 may be configured such that there is more space between the strap and the patient's ears, e.g., move upper side straps 22 away from the patient's ears as shown in
In another alternative embodiment, one or more straps of the headgear 20 may include a relatively soft cover, sock, or pad, e.g., constructed or foam or gel, to improve comfort and/or aesthetics. The cover, sock, or pad may be attachable and retrofittable to the headgear straps. In an embodiment, the cover, sock, or pad is especially provided near the patient's eyes and/or cheeks. For example,
In another alternative embodiment, as schematically shown in
In another alternative embodiment, an outrigger may be incorporated into the headgear 20 and/or frame 12 to help stabilize the frame 12 on the patient's face.
In another alternative embodiment, as shown in
In another alternative embodiment, as shown in
The upper and lower side straps 22, 24 of the HYBRID™ headgear 20 each include a Velcro® tab 40 that engages the remainder of the strap 22, 24 to secure a buckle 42 in place. Each buckle 42 is adapted to engage a respective post 44 (e.g., mushroom-shaped post) on the frame 12 to secure the headgear 20 to the frame 12. Specifically, each buckle 42 is interlocked with a respective post 44 by first moving the buckle 42 adjacent the respective post 44 such that the respective post 44 extends through a larger opening in the buckle 42, and then moving the buckle 42 into engagement with the post 44 to interlock the post 44 with a smaller opening in the buckle 42 (e.g., see
In an alternative embodiment, as shown in
An exemplary embodiment of such a finger tab is disclosed in U.S. patent application Ser. No. 10/584,711, filed Jun. 26, 2006, which is incorporated herein by reference in its entirety.
In an alternative embodiment, as shown in
In an alternative embodiment, the buckle/post headgear connection of the HYBRID™ mask 10 may be replaced by locking clips, e.g., spring-loaded clip, adapted to engage respective clip receptacles provided to the frame. Exemplary clip arrangements are described in PCT Application No. PCT/AU2006/000770, filed Jun. 6, 2006, and U.S. Pat. Nos. 6,374,826 and 6,907,882, each of which is incorporated herein by reference in its entirety.
In an embodiment, the locking clip may be configured to lock into at least one configuration or direction, e.g., lockable angular adjustment.
In another embodiment, each side of the frame may include only one clip/receptacle headgear connection (e.g., use with headgear shown in
In another embodiment, the locking clip and/or clip receptacle may include a ratcheting arrangement to allow indexed rotational adjustment.
In another embodiment, the clip receptacle regions of the frame may be constructed of a malleable material to allow the clip receptacles to be positioned at different angles. In yet another embodiment, the clip receptacle regions of the frame may include a lockable ball joint to provide limited movement of the clip receptacles.
In an alternative embodiment, the buckle and/or post may be keyed to prevent rotation of the buckle when attached to the post. This arrangement will maintain the headgear straps in a particular orientation or direction. For example,
In an alternative embodiment, a peg or post may be provided on a headgear strap that is adapted to engage within a respective hole provided to the frame.
In an alternative embodiment, a press-button quick release mechanism may be incorporated into the headgear connection, e.g., such as that described in Australian Patent Application No. AU 2005100738 A4, filed Sep. 8, 2005, which is incorporated herein by reference in its entirety.
In an alternative embodiment, a spring-biased pull tab quick release mechanism may be incorporated into the headgear connection.
In an alternative embodiment, as shown in
The frame 12 of the HYBRID™ mask 10 includes a main body 50 having a gas entry port 52 adapted to connect to the elbow assembly 18. The frame 12 also includes supplemental oxygen ports 54, vent holes 56, and posts 44 adapted to engage buckles 42 provided to the headgear 20 (e.g., see
In an alternative embodiment, as shown in
In an alternative embodiment, as shown in
The nasal prongs or nasal pillows 16 of the HYBRID™ mask 10 each include a single-wall head portion 60 adapted to provide a seal with the patient's nasal passage and a base portion 62 adapted to be mounted to the cushion 14. The base portion 62 is formed with rings 64 defining at least one groove 66 therebetween. The cushion 14 includes two portals 68 that define flanges adapted to engage a respective groove 66 to secure the prong 16 in position (e.g., see
In an alternative embodiment, as shown in
In another alternative embodiment, the head portion 60 of each prong may include more than two walls, e.g., three or more walls.
In an alternative embodiment, each nasal prong 16 may include a trampoline-like base portion. Specifically, as shown in
In an alternative embodiment, one or more alignment indicators may be added to the prongs 16 and/or cushion 14 to aid alignment of the prongs 16 with respect to the cushion 14. For example, alignment indicators 75 may be provided to the prongs 16 (see
In an alternative embodiment, the prong 16 may be configured to extend at different prong angles as the prong 16 is rotated. For example, as schematically shown in
As shown in
In an alternative embodiment, the wall thickness of each prong may be reduced, e.g., to about 0.5 mm.
In an alternative embodiment, each prong 16 may be rotatable relative to the cushion 14, and the prong rotation may include indexing or incremental stops.
In an alternative embodiment, as shown in
In an alternative embodiment, as shown in
In an alternative embodiment, the base of each prong 16 may include a gimble or universal joint for adjustment.
In an alternative embodiment, each prong 16 may have a preload to provide a sealing force with the patient's nare.
In an alternative embodiment, one or more of the rings 64 at the base portion of each prong 16 may be sized such that the prong 16 cannot push through the respective portal in the cushion 14. For example,
In an alternative embodiment, as shown in
In an alternative embodiment, as shown in
The cushion 14 of the HYBRID™ mask 10 includes a chin portion or chin flap 80, an upper surface defining two portals 68 adapted to mount respective nasal prongs 16, a face-contacting portion having a double wall configuration (e.g., membrane 82 and undercushion 84), and a non-face-contacting portion having a leading edge 86 adapted to engage a groove 88 provided to the frame 12 to secure the cushion 14 to the frame 12 (e.g., see
As shown in
In an alternative embodiment, as shown in
An exemplary cushion with a gusset is described in U.S. patent application Ser. No. 10/655,622, filed Sep. 5, 2003, which is incorporated herein by reference in its entirety.
The leading edge of the HYBRID™ cushion is a substantially flat wall, which may easily disengage from the groove in the frame, e.g., especially when greasy. In an alternative embodiment, a lip, lug, bead, and/or or rib may be provided to the leading edge of the cushion to better retain the cushion to the frame. Such retaining structures are disclosed in U.S. patent application Ser. No. 10/390,682, filed Mar. 19, 2003, which is incorporated herein by reference in its entirety.
In an alternative embodiment, the face-contacting portion may include more than two walls, e.g., membrane 82 and two or more undercushions 84.
In an alternative embodiment, the cushion may have a preload to provide a sealing force.
In an alternative embodiment, one or more alignment indicators may be added to the cushion 14 and/or frame 12 to aid alignment of the cushion 14 with respect to the frame 12. For example,
In an alternative embodiment, the chin flap 80 may be adjustable, e.g., indexed or incremental adjustment. In an embodiment, as shown in
In an alternative embodiment, the chin flap 80 may include multiple chin supports.
In an alternative embodiment, cheek supports may be provided to the cushion 14, e.g., cheek wings, such as the cheek support shown in
In an alternative embodiment, the cushion may be configured or shaped to accommodate the patient's septum and/or nasal bridge. Such cushion arrangements are disclosed in U.S. patent application Ser. No. 10/390,682, filed Mar. 19, 2003, and U.S. Pat. No. 6,112,746, each of which is incorporated herein by reference in its entirety.
The elbow assembly 18 of the HYBRID™ mask 10 includes an elbow 90 and a swivel coupling 92 provided to the elbow 90. The elbow 90 includes a first portion 94 attachable to the frame 12 and a second portion 96 attachable to the swivel coupling 92. Also, the elbow 90 includes a port 98 that is selectively closed by an anti-asphyxia valve 99 (e.g., see
As shown in
In the commercial embodiment of the HYBRID™ mask 10, excessive noise is caused by significant leakage through the elbow to frame interface. In an alternative embodiment, the manufacturing tolerances of the elbow 90 and/or frame 12 may be improved to reduce noise caused by leak through the elbow to frame interface.
In an alternative embodiment, as shown in
In another alternative embodiment, a swivel coupling 92 may be provided over the elbow 90 to reduce the size of the elbow 90.
In another alternative embodiment, the elbow to frame connection may include a ball joint arrangement.
In another alternative embodiment, the frame 12 may include two gas entry ports 53, e.g., one on each side of the frame as shown in
In another alternative embodiment, the elbow assembly may be constructed of materials to prevent “squeaking” in use.
In another embodiment, the swivel coupling may permanently attach to the elbow with a snap-fit, e.g., to prevent separation.
In another embodiment, the elbow may be structured to facilitate removal of the anti-asphyxia valve, e.g., for cleaning so that the mask is suitable for use by multiple patients. For example, the anti-asphyxia valve may be attached to a removable clip member that is removably attachable to the elbow. Exemplary anti-asphyxia valve assemblies are disclosed in PCT Publication No. WO 2007/045008, published Apr. 26, 2007, which is incorporated herein by reference in its entirety.
The HYBRID™ frame 12 includes six vent holes 56 for CO2 washout. The vent holes 56 are positioned above the gas entry port 52 and aligned along a horizontal axis (e.g., see
In an alternative embodiment, the size of each vent hole 56 may be smaller and the number of vent holes 56 provided to the frame 12 may be increased, e.g., greater than six vent holes (e.g., 6-60 vent holes). Exemplary vent arrangements are disclosed in U.S. Pat. No. 6,581,594 and PCT Application Nos. PCT/AU2006/000770, filed Jun. 6, 2006, and PCT/AU2006/001507, filed Oct. 13, 2006, each of which is incorporated herein by reference in its entirety.
In an alternative embodiment, as shown in
In the commercial embodiment of the HYBRID™ mask 10, the vent holes 56 direct washout gas along a generally horizontal plane or axis of the frame 12. In an alternative embodiment, as shown in
In another alternative embodiment, as shown in
In an alternative embodiment, one or more vent holes for CO2 washout may be provided in the base of each nasal prong 16 and/or in the cushion 14.
In another alternative embodiment, as shown in
In another alternative embodiment, the two port cap 55 may be tethered to one another, e.g., double ports cap. Such an arrangement is disclosed in U.S. Pat. No. 6,439,230, which is incorporated herein by reference in its entirety.
The following embodiments describe additional improvements and/or alternative arrangements of the HYBRID™ mask.
In an alternative embodiment, as schematically shown in
In an embodiment, the forehead support may include forehead pads that extend up and around the outside of the patient's eyes. Exemplary forehead pads are disclosed in U.S. patent application Ser. No. 10/655,595, filed Sep. 5, 2003, which is incorporated herein by reference in its entirety.
In another embodiment, the forehead support may include a nose support adapted to engage the nose and provide a support and stability mechanism between the mask and the patient's nose.
In another embodiment, the forehead support may include a cheek support adapted to engage the patient's cheeks and provide a support and stability mechanism between the mask and the patient's cheeks, e.g., such as the cheek support shown in
In an alternative embodiment, the HYBRID™ mask 10 may include an intra-oral bite or dental insert provided within the patient's mouth. In an embodiment, the insert may constitute a mandibular advancement device structured to advance the position of the patient's lower jaw. An exemplary mandibular advancement device is disclosed in PCT Application No. PCT/AU2006/001095, filed Aug. 2, 2005, which is incorporated herein by reference in its entirety.
In another alternative embodiment, the frame 12, cushion 14, nasal prongs 16, and/or headgear 20 of the HYBRID™ mask 10 may be constructed of a malleable material to allow bending for conformance to the patient's head and/or face, e.g., conform mask to suit different faces.
In another alternative embodiment, the frame 12 and/or cushion 14 may include an articulating feature that allows the jaw to move in use. The articulating feature may be adjustable and lockable.
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.
This application claims the benefit of U.S. Provisional Application No. 60/935,268, filed Aug. 2, 2007, which is incorporated herein by reference in its entirety.
Number | Date | Country | |
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Parent | 15405829 | Jan 2017 | US |
Child | 17079468 | US |