The present invention relates to the field of respiratory masks, e.g., for use with positive pressure therapy for patients who suffer from obstructive sleep apnea (OSA). In particular, the invention is directed to a mask assembly including a mask frame including at least one gel component, e.g., in the form of a cushion or forehead support.
Masks adapted for infusion of a fluid, e.g., gas, to a patient, in particular those suffering from OSA, are required to deliver the fluid, to seal on the patient's face, to be adaptable with any patient movement, and to be comfortable.
Some prior art masks may be comfortable and compliant, but do not seal optimally, thus making the masks less effective. Often, the frame for the mask is hard plastic and thus sealing and compliance must come from the facial cushion. Generally, this is not well done.
A very sensitive area of the face where seal is usually located is the nasal bridge region. Usually, any increase in pressure is directly translated to the nasal bridge region and is thus uncomfortable and even painful. Early gel masks had flowable-type gels which, when the membrane was worn out or ruptured, could leak out into the airways, which is an obvious health hazard. On the other hand, prior art mask systems available from DeVilbiss Serenity™ Gel, SleepNet IQ™, Respironics Profile Lite™ and Hans Rudolph Ultimate Seal™ include gels that are substantially not flowable.
Current gel masks do not seem to offer any great advantages with respect to sealing, except that patients may perceive them as intrinsically feeling that they would seal. Current sealing is actually done by a polyurethane membrane which does not last, stretches and/or corrugates, thus compromising the seal. An example of such a gel cushion is U.S. Pat. No. 5,884,624 to Barnett et al.
Gel is a good absorber of pressure (e.g., areas of high contact pressure may be redistributed), but not necessarily a good sealing medium, particularly when it has no compliance (e.g., by not being able to remain in intimate contact with the patient's skin due to minor relative movement, such as experienced by natural body movement). “Compliance” is the level of displacement achievable between the patient's face and cushion and/or the mask's ability to maintain a comfortable seal. ResMed's Activa™ cushion is an example of a cushion with very good compliance.
The lack of compliance and resilience may affect seal performance and may create localized pressure points such as on higher facial landmarks, especially the nasal bridge region.
Exemplary means to achieve good compliance in cushions includes Bubble® cushions that have very thin membranes able to utilize air pressure to maintain intimate contact with the patient's face.
More recent developments to improve compliance include ResMed's Mirage Activa™ mask that has a thin-walled, expandable cell between the cushion seal and the mask frame. The expandable cell maintains constant pressure of the seal onto the patient's face and allows for high levels of compliance to maintain seal even with large levels of mask instability relative to the patient.
DeVilbiss Serenity™ Gel includes a gel section that is not in contact with the patient's face; the thinner membrane is the seal.
Respironics Profile Lite™ has a deformable layer between the sealing region and the mask. This layer may somewhat pre-shape the cushion profile closer to an individual face, however has nearly no effect on improving compliance and seal performance. This somewhat customizable layer is required because the cushion does not have the ability to substantially redistribute contact pressure regions.
In summary, existing masks are lacking in two major areas: effective seal compliance and their ability to substantially redistribute contact pressure forces.
In fact, though constructed from known gel-like materials, prior art products behave and feel much like soft elastomers, rather than partly or substantially flowable fluids.
Also, compromises have been made to the softness (generally stiffer materials are used) so that structural integrity can be maintained. For example, a soft cushion may not seal well as the walls may splay outwards under pressure and leak.
A cushion that is made softer and made of softer materials, such as gel, may be better at redistributing forces on the face to eliminate contact pressure points and/or maximize the contact area to minimize contact pressure points (as smaller surface area results in higher pressure, i.e., Pressure=Force/Area).
The problem with constructing a softer cushion using current art methods is that they provide very limited structural integrity because the soft walls would splay outwards under pressure and cause leak. The construction methods are therefore limited in their “containment” ability.
Accordingly, one aspect of the present invention is to address one or more problems associated with prior art gel systems.
An aspect of the invention relates to embodiments structured to create a substantially softer and therefore more comfortable gel mask that has structural integrity.
Another aspect of the invention relates to embodiments structured to provide containment of a gel seal to prevent the gel seal or side-walls from buckling or splaying outwards under treatment pressure or high headgear strap tension (causing mask to crush harder into the patient's face).
Another aspect of the invention is to provide a gel contained within a skin portion that is flexible and stretchable, e.g., elastic.
Yet another aspect is directed to a gel configuration that allows for the use of multiple gels or fluids with different properties to affect seal performance and compliance.
Still another aspect relates to a mask system having a gel that is substantially flowable but not pourable.
According to one embodiment of the invention, there is provided a cushion comprising a face contacting element having at least one portion including at least a first gel (e.g., flowable but not pourable); and a silicone-based skin portion (e.g., elastic, stretchable and flexible) containing at least the first gel.
According to another embodiment of the invention, there is provided a cushion comprising a face contacting element having at least one portion including at least a first gel and a second gel; and a skin portion containing at least the first and second gels, wherein the second gel is different from the first gel in at least one respect.
According to yet embodiment of the invention, there is provided a cushion comprising a face contacting element having at least one portion including at least a first gel, the face contacting element being substantially triangular and including a nasal bridge region, cheek regions and a lower region opposite to the nasal bridge region, said face-contacting portion defining at least in part a breathing chamber; and a skin portion containing at least the first gel, wherein at least one of the cheek regions and the lower region includes a concave section that curves inwardly towards the breathing chamber.
Another aspect of the invention relates to a cushion that provides adequate compliance without substantially increasing the size.
Another aspect of the invention relates to a cushion including at least a gel and at least one other fluid, e.g., gel layer and gas/air layer.
Another aspect of the invention relates to a cushion or seal including one or more of the following features: an elastic skin (improve flow of gel and comfort), flowable gel (comfort), elastic/spring cuff (increased comfort and acknowledges more sensitive regions around nose), variable spring rates around nose (acknowledges more sensitive regions around nose), bilobular design (to assist with seal containment), biased lean (to assist with seal containment), and seal support (to assist with seal containment). The above-noted features may be used independently or may be used in combinations.
Another aspect of the invention relates to a cushion including a face contacting element having at least a portion containing a gel and a containment wall provided adjacent the portion containing the gel. The containment wall is adapted to contain displacement of the portion in use.
Another aspect of the invention relates to a nasal prong arrangement including a base, a pair of nasal prongs provided to the base, and a deforming mechanism provided adjacent each nasal prong. Each of the nasal prongs contains a gel material adapted to deform and seal to the patient's nare. Each deforming mechanism is adapted to selectively engage and deform the respective nasal prong.
Another aspect of the invention relates to a nasal prong arrangement including a base, a pair of nasal prongs provided to the base, and a ring containing a gel material provided to each nasal prong. Each gel ring is adapted to be supported by a rib or base of the prong and provide a gel-type seal with the patient's nare in use.
Another aspect of the invention relates to a cushion including a gel component adapted to provide a seal and a deforming mechanism provided adjacent the gel component and adapted to selectively engage and deform the gel component.
Another aspect of the invention relates to a nasal prong assembly including a nasal prong arrangement and headgear adapted to support the nasal prong arrangement on the patient's face. The headgear includes a support strap containing a gel material that is adapted to sit over the patient's nose in use.
Another aspect of the invention relates to a cushion including a seal portion adapted to provide a seal with patient's face and a gusset portion extending from the seal portion and adapted to dampen movement of the cushion in use. The seal portion or gusset portion includes at least a portion containing a gel.
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:
1. Cushion with Gel Layer
A cushion 20 includes a face contacting element 22 and a frame engaging portion 24. An adaptor plate 25 is provided to fix the cushion 20 to the frame 12 and a cushion-to-frame attachment point 27, e.g., glue line, is provided to secure the cushion 20 to the frame 12. In the illustrated embodiment, the cushion 20 provides three layers, i.e., the first layer is a gel layer 29(1), the second layer is a separation layer 29(2), and the third layer is an elastic cuff or spring layer 29(3).
While the mask assembly shown in
As shown in
1.1 Concave Sections
As shown in
As shown in
2. Gel Seal or Cushion
2.1 Variable Profile
In an embodiment, the gel cushion may provide a variable profile/height around the gel cushion and flexibility may be modified by wall thickness or by using different thickness composites. For example,
2.2 Containment Wall
In an embodiment, a containment wall may be provided to the gel cushion to provide lateral stability and support. For example,
Testing shows that very little force may be provided to improve the seal by containment of the sealing region, e.g., see
The containment wall allows the cushion to remain soft and compliant for maximum comfort without compromising seal (e.g., prior art requires relatively stiffer cushion sidewalls to prevent leak).
Such embodiments of a gel seal or cushion may be applied into forehead pads or other interfacing pads, e.g., cheek pads.
3. Dual Wall Concept
The dual wall construction shown in
3.1 Roll Effect
3.2 Variations Around Perimeter
3.3 Skin Portion Characteristics
Skin portion 38 is flexible and stretchable (e.g., elastic). This allows for compliance and adaptability of the mask to the user's face, similar to that of the ACTIVA mask, but without the extra section that makes the mask bulkier. This will happen without having any extra pressure as the gel will be allowed to conform with applied force, minimizing the resultant pressure. This is particularly true if used in conjunction with straps attached to the head only.
The skin portion containing the first gel may be elastic. The skin portion may be similar to the outer membranes of the cushion of ResMed's commercially available Ultra-Mirage® Full Face Mask which is made from silicone such as, e.g., Silastic®.
4. Gel Characteristics
The gel may be flowable but not pourable. An example of such a gel is commercially available from NuSil, a U.S. company, under the name Gel 8150. In addition, the gel may be dynamic and/or adaptive. Further, the gel is configured for temporary deforming or self-leveling.
Moreover, the gel and/or the skin portion can initially be placed under pretension, which leads to less crinkling of the skin portion when placed on the face and deformed further. The gel could have phase change properties that change with force, pressure or temperature.
5. Ball and Socket
Frame 53 includes a cradle 58 which is constructed to support a face contacting element 60. As shown in the enlarged partial view in
The frame is made of a light polymer. The cradle is generally U-shaped in the embodiments of
6. Single Piece Mask
7. Multiple Gel Mask
Face contacting element 86 includes a skin portion which encapsulates or encases a first gel 90, a second gel 92 and a third gel 94, each of which may have properties that are different from one another. For example, gel 90 may be a relatively harder gel, while gels 92 and 94 may be relatively softer gels. The soft or resilient gels 92, 94 are used to seal and comply dynamically while the harder gel 90 is used to comply with the facial topography and any other slow changing external forces. Gels 90, 92 and 94 may be provided within separate and discrete chambers defined, for example, by divider walls 97, 98. In another variant, gels 92, 94 may be the same and/or have the same characteristics, while divider wall 98 may simply form a support for enhanced positioning and/or sealing.
A thin membrane 96 may be provided to extend away from the skin portion. The membrane 96 may extend outwardly in a direction that generally bisects the face contacting element. Membrane 96 may extend along a line that is aligned with divider wall 98 between second and third chambers containing the second and third gels 92, 94 respectively. Membrane 96 is structured to define a convex sealing surface projecting inside the face contacting portion.
8. Flat Cushion With Bellows
9. Triple Gel Cushion
The use of multiple gels (two or more) provides three functions, sealing, compliance and comfort. The resilient gel can seal well and comply to any dynamic changes of the face or external disturbances of the mask. Most current masks do not seal well and comply with changes without high strap tension, which is not comfortable.
A slow flowing gel can adapt to the contours of the face and to any slow changing external disturbances. Other methods of adapting to facial contours include malleable wires and heat forming cushions have not proven to be successful and only allow for initial placement but they do not adapt to any changes and are not able to cope with other problems. By its very nature, gel is a soft comfortable substance. When a softer than human facial fat tissue gel is chosen, and combined with a stretchable skin, the cushion feels very comfortable under various conditions.
10. Dual Gel Cushion
11. Alternative Gel Applications
11.1 Seal
11.1.1 Gel Seal in Nostrils
In an alternative embodiment, a gel-type seal may be provided to a nasal prong arrangement. For example,
As shown in
In an embodiment, the gel-type prongs may be provided at the end of a flexible tube (e.g., if the seal is adapted to support the weight of the air delivery tube and prevent the air delivery tube from pulling the prongs out of the patient's nose).
In alternative embodiments, the deformable and self-sealing gel prongs may have other suitable forms or arrangements. Besides gel-filled bodies deformed by mechanical action, the prongs may include self-fitting or expanding bodies using expansion foam (e.g., similar to existing earplugs) or a combination of visco-elastic foam and gel (e.g., using the foam for the self-expanding fit and the gel as the seal against the inside of the patient's nares).
11.1.2 Visual Indicator Particles
In an embodiment, visual indicator particles (e.g., glitter) may be added to the gel material. The density of the particles changes as they are spread under contact pressure. In such an arrangement, the areas of highest deformation would become visually clear as the particles would spread apart from one another. The areas of highest deformation may indicate where pressure sores may become a problem. Once the problem areas are identified, they can be accommodated by the design of the cushion.
11.1.3 Gel Rings
In an embodiment, rings formed of a gel material may be provided to respective nasal prongs in an existing nasal prong arrangement (e.g., such as the SWIFT® nasal prong arrangement described above) to aid sealing. For example, as shown in
11.2 Seal Enhancement
11.2.1 Gel to Provide Even, Distributed Load
In an embodiment, gel may be used in a mask to turn or convert an adjustable point force into an evenly, distributed load. Specifically, mask seal may be improved or enhanced by using the deformable property of gel and its ability to adapt to the geometry of shapes.
A deforming mechanism may be provided to mechanically adjust the gel seal's shape, e.g., screws, cams, or other mechanical arrangements. The deforming mechanism along with the gel component, e.g., gel strip, cooperate to provide a seal. For example,
If sufficient deforming mechanisms (e.g., screw adjustors) are provided to a mask, this type of system may be used to significantly adjust the shape of the mask and provide a customizable fit. For example, as shown in
11.2.2 Gel Pads
In an embodiment, gel pads may be used to “shape” the patient's nose to dilate nasal passages for a better shape for sealing.
11.2.3 Adjustable Force to Gel Pocket
In an embodiment, an adjustable force may be used to gel pocket to modify the shape and “hardness” in different regions of the mask.
11.2.4 Gel Mouth Seal
In an embodiment, a mouth seal adapted to form a seal with the patient's mouth may be constructed of a gel material, e.g., gel-filled component.
11.3 Support Structures
11.3.1 Gel Skeleton or Shell
In an embodiment, gel may be used to form a skeleton or shell that is adapted to support one or more components of a mask, e.g., cushion.
11.3.2 Gel Support Strap
In an embodiment, gel may be used to form a strap or headgear strap of a mask. For example, as shown in
11.3.3 Gel Pads
In an embodiment, gel pads may be provided to a mask that are adapted to rest on the sides of the patient's nose in use (e.g., gel pads rest on the alar sidewalls). For example,
11.3.4 Gel Earplugs
In an embodiment, gel earplugs may be provided to headgear to enhance mask retention. For example,
11.4 Comfort
11.4.1 Comfort Support Pad
In an embodiment, a comfort support pad may be provided that is adapted to engage the patient's upper lip in use. For example,
11.4.2 Inserts
In an embodiment, inserts (e.g., gel or foam inserts) may be provided to the inner side of one or more headgear straps to prevent the headgear from making marks on the patient's face in use. For example,
11.4.3 Gel Pads
In an embodiment, gel pads may be provided to one or more portions of the mask.
11.4.4 Heated Gel
In an embodiment, gel may be provided with heat pack crystals (e.g., sodium acetate and water with a metal clicker) or other suitable heating arrangement to provide a heated gel in use.
11.4.5 Impregnated Foams
In an embodiment, foam may be impregnated with oils or scents adapted to stop the patient's skin from drying out during the night and generally provide the patient's skin with a helpful product.
11.5 Alignment and/or Stability
In an embodiment, gel may be incorporated into a mask to improve alignment and/or stability in use. For example, gel may be incorporated into the gusset portion of a gusseted cushion to act as a mechanical dampener in use.
In an alternative embodiment, as shown in
In another embodiment, gel pads may be provided to a nasal prong arrangement (e.g., such as the SWIFT® nasal prong arrangement described above) to act as stabilizers in use.
11.6 Headgear Applications
11.6.1 Gel Pads
In an embodiment, gel pads may be provided to one or more portions of mask headgear.
11.6.2 Gel/Foam Headgear
In an embodiment, gel and/or foam may be used in headgear to give it a more self-supporting structure. For example,
11.6.3 Gel Pads or Memory Foam Pads
In an embodiment, gel pads or memory foam pads may be provided on the inside of buckles and/or adjustment clips of mask headgear to prevent the patient's head from resting against the relatively hard material of the buckles or clips. For example,
11.6.4 Gel/Foam Ear Pads
In an embodiment, gel and/or foam ear pads may be provided that are adapted to extend over the patient's ears in use (e.g., ear pads adapted to cover or rest on the patient's ears). For example,
11.6.5 Gel Displacement
In an embodiment, gel may be provided in one or more portions of the headgear and the gel's displacement may be used to displace or shift headgear over-tensioning. For example, gel may be provided to headgear in a manner as shown in
11.6.6 Gel Conduit Headgear
In an embodiment, at least a portion of conduit headgear (e.g., tubing adapted to support mask on a patient's head) may include a gel component to increase comfort in use.
11.6.7 Gel Mattress
In an embodiment, a gel mattress may be incorporated into headgear to improve comfort and conformability of the headgear in use. For example,
11.6.8 Additives
In an embodiment, additives (e.g., air bubble, glitter, color, air bubbles via an aeration process, glass beads, etc.) may be provided to gel and/or foam which can provide a visual indication where compression is highest in use. Air bubbles may indicate aeration of the material.
11.7 Gel Characteristics
Gel adapted for use in breathing mask applications may provide one or more of the following characteristics: noise dampening, load distributing (reducing pressure points), soft feel regions, energy conversion (e.g., heatable), tacky features, and/or clear/tintable. In an embodiment, the “flow” of gel may be adapted to provide a seal around nasal hairs like mucous. In another embodiment, the gel may be microwavable to provide warmth in use.
Some alternatives to gel for use in breathing mask applications include: oil-suspended foam, visco-elastic foam, floam, and low duro silicone.
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 in non-medical applications.
This application is a continuation of U.S. application Ser. No. 14/800,135 filed on Jul. 15, 2015, which is a divisional of U.S. application Ser. No. 12/081,114 filed on Apr. 10, 2008, which claims priority to U.S. Provisional Application No. 60/907,609, filed Apr. 11, 2007, the entire contents of each of which are hereby incorporated by reference.
Number | Date | Country | |
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60907609 | Apr 2007 | US |
Number | Date | Country | |
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Parent | 12081114 | Apr 2008 | US |
Child | 14800135 | US |
Number | Date | Country | |
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Parent | 14800135 | Jul 2015 | US |
Child | 16015014 | US |