Source: https://patents.google.com/patent/US8807135B2/en
Timestamp: 2019-04-22 17:27:41+00:00

Document:
A cushion for a patient interface includes an outer membrane providing a sealing structure adapted to form a seal with the patient's face in use and an underlying membrane generally spaced away from the outer membrane. The underlying membrane provides a support structure for the outer membrane. The outer membrane and the underlying membrane each have an inner edge which defines an aperture to receive the patient's nose in use. The underlying membrane is segmented along its inner edge.
This application is the US national phase of international application PCT/AU2005/000803 filed 3 Jun. 2005, which designated the U.S. and claims the benefit of Australian Provisional Application No. 2004902979 filed Jun. 3, 2004, each incorporated herein by reference in its entirety.
The invention relates to treatment of sleep disordered breathing. In particular, the invention relates to a cushion for a patient interface used for treatment of sleep disordered breathing.
The use of nasal Continuous Positive Airway Pressure (nasal CPAP) to treat Sleep Disordered Breathing (SDB), for example Obstructive Sleep Apnea (OSA), was invented by Sullivan (See U.S. Pat. No. 4,944,310). Such treatment is typically accomplished using a source of air at positive pressure (e.g., a blower or flow generator) connected to a patient interface (e.g., a mask) via an air delivery conduit. To maintain a suitable pressure at the entrance to the patient's airways, it is necessary to provide a suitable seal between the patient interface and the patient's face. Early masks were glued to a patient's face every night. Today, however, the patient interface is usually held in position with headgear. Treatment is very successful in reducing SDB. However, gas pressurized in the range of 4-20 cmH2O can be noisy and uncomfortable. Poorly fitting masks can provide an inadequate seal against leak. After wearing a mask all night, some patients can have pressure sores on their faces, especially in such sensitive regions as the nasal bridge. Thus, mask designers and manufacturers are constantly striving to provide patient interfaces which provide a comfortable seal.
A variety of masks are available, such as nasal, full-face, and nose and mouth masks.
ResMed's MIRAGE® mask provided a significant improvement in masks for CPAP treatment. FIGS. 1-3 illustrate an embodiment of ResMed's MIRAGE® mask. It is available in both nasal and full-face versions. In the illustrated embodiment, the mask 2 includes (i) a rigid shell or frame 3 that defines a nose-receiving chamber, and (ii) a face-contacting cushion 4. The cushion 4 plays a role in improving the comfort and seal of the mask. For example, see U.S. Pat. Nos. 6,112,746; 6,357,441; 6,581,602 and 6,634,358. Other aspects of the mask, such as a forehead support and vent also play a role in the fit, comfort, and noise of a mask.
As shown in FIGS. 4-6, the cushion 4 of the MIRAGE® mask includes a dual membrane structure. As illustrated, the cushion 4 includes a thinner outer membrane 6 that is spaced away from a thicker inner or underlying membrane 8 at their inner edges.
The present invention is particularly directed towards a cushion with an improved inner or underlying membrane.
One aspect of the invention relates to a cushion for a respiratory mask having a segmented support structure.
Another aspect of the invention relates to a cushion for a respiratory mask having a dual membrane structure with an outer membrane and an underlying membrane divided into a series of finger portions.
Another aspect of the invention relates to a cushion for a patient interface. The cushion includes an outer membrane providing a sealing structure adapted to form a seal with the patient's face in use and an underlying membrane generally spaced away from the outer membrane. The underlying membrane provides a support structure for the outer membrane. The outer membrane and the underlying membrane each have an inner edge which defines an aperture to receive the patient's nose in use. The underlying membrane is segmented along its inner edge.
Still another aspect of the invention relates to a cushion adapted to be mounted on a frame of a patient interface for use with treatment of sleep disordered breathing. The cushion includes an outer membrane and an underlying membrane. The outer membrane is thinner than the underlying membrane and is generally spaced away from the underlying membrane and in use is adapted to contact a facial region of a patient. The underlying membrane has an inner edge defining an aperture and is divided along the edge to form a series of finger portions.
Yet another aspect of the invention relates to a cushion for a patient interface. The cushion includes a membrane and an underlying support structure provided along a side of the cushion to support the membrane. The underlying support structure is segmented.
FIGS. 13-14 show rear and side views of a cushion of the mask of FIG. 7, and the cushion opening has not been cut from molding.
In a dual walled cushion, the outer wall (outer membrane) can define a sealing structure and the inner wall (inner membrane) can define a support structure. A seal can form when a patient's face is lightly pressed against the outer membrane. However, the outer membrane will easily flex upon contact with the patient's face. The inner membrane is generally thicker and more rigid than the outer membrane. When a patient's face presses against the outer membrane, the gap between the two membranes reduces. At a larger contact force, there may be no gap between the two membranes. With a yet higher contact force, the inner membrane will also begin to flex. In response to a contact force from a patient's face to the cushion, the cushion will provide a reaction force from the cushion to the patient's face. The size and direction of the resultant reaction force in a particular region will depend upon the face and cushion properties in that region.
FIG. 7 illustrates a patient interface in the form of a full-face mask 10 including a cushion 14 in accordance with an embodiment of the invention. The cushion 14 is structured to be attached to a substantially rigid frame 12 associated with an air delivery tube. The cushion 14 may be removably or permanently attached to the frame 12 in any suitable manner.
As illustrated, the cushion 14 has a thin outer membrane 16 and a thicker underlying membrane 18 generally spaced away from the outer membrane 16. The outer membrane 16 provides a sealing structure to form a seal with the patient's face, and the underlying membrane 18 (also referred to as an underlying support) provides a support structure for the outer membrane 16. Both the outer and underlying membranes 16, 18 have an inner edge which defines an aperture through which a nose passes in use.
In the illustrated embodiment, the outer membrane 16 forms a seal with a nasal bridge region NB, cheek regions CR, and a lower lip region LL of the patient's face. Also, the cushion 42 has a double-walled construction, i.e., outer membrane 16 and underlying membrane 18, in the cheek regions CR and a single-walled construction, i.e., outer membrane 16, in the nasal bridge and lower lip regions NB, LL. The single wall construction at the top and bottom of the cushion 14 allows flexibility to accommodate a wide range of patients. However, the cushion 14 may have any other suitable construction, e.g., single walled, triple walled or more walled construction, in any suitable region of the cushion 14.
As best shown in FIGS. 8-10, the underlying membrane 18 is segmented along its inner edge. In the preferred embodiment, the line of segmentation is generally perpendicular to the edge, however in other forms it may not be. The segmentation provides a set of finger portions 17 interconnected by webbing 19.
In the illustrated embodiment, the underlying membrane 18 is a continuous material with the webbing 19 formed in a different plane than the finger portions 17. However, the webbing 19 may have other suitable configurations. For example, the webbing 19 may be in the form of one or more connecting members than extend between and interconnect at least adjacent portions of adjacent finger portions 17. The one or more connecting members may be positioned between intermediate portions of adjacent finger portions 17 so that tips of the finger portions are exposed. Alternatively, the one or more connecting members may be positioned between end portions of adjacent finger portions 17 so that the connecting members are substantially continuous with tips of the finger portions. Other arrangements are also possible to reinforce and interconnect the finger portions 17.
Each finger portion 17 is generally independently flexible. That is, a local force on one group of finger portions 17 will not directly transfer to an adjacent group. Thus, flexion of the cushion 14 in one region will not necessarily cause flexion of the cushion 14 in an adjacent region to the same extent as the prior art. This arrangement provides independent suspension of different facial regions in contact with the cushion 14, and allows the cushion 14 to conform more closely to the patient's face.
Furthermore, in the nasal bridge region NB and lower lip/chin region LL (see FIG. 7), the underlying membrane 18 is progressively or completely shortened. Reducing or eliminating the underlying membrane 18 in these regions of the cushion 14 means the outer membrane 16 can “give” more when a face contacts it. This arrangement can improve comfort in these sensitive regions.
In one form, the cushion 14 is mechanically equivalent to a series of composite springs placed around a nose receiving aperture of the frame. The composite spring has mechanical properties derived from the combination of the sealing and support structures, which in one form are two membranes. The properties of the “springs equivalents” in the nasal bridge and lower lip/chin regions NB, LL can be and preferably are different than those in the cheek regions CR (see FIG. 7), in this embodiment.
FIGS. 11 and 12 illustrate a cushion 214 according to another embodiment of the invention. In this embodiment, the cushion 214 includes an outer membrane 216 and underlying membrane 218 segmented into a set of finger portions 217. In contrast the cushion 14, there is no webbing between the finger portions 217 of the cushion 214. Like the previous embodiment, the fingers 217 are progressively shorter in a nasal bridge region NB of the cushion 214 (see FIG. 12). In an embodiment, the depth and/or length of the slot between adjacent finger portions 217 may be selectively adjusted to adjust the flexibility of selected finger portions 211. The depth and/or length of the slot may be adjusted so that the finger portions 217 are more flexible in certain regions of the patient's face.
In the two above-described embodiments, the cushion 14, 214 is constructed from silicone. However, other materials may be used, such as gel and foam. FIGS. 11-12 show a MIRAGE® full face cushion modified in accordance with the invention.
Other views of the segmented cushion 14 with webbing are shown in FIGS. 13 and 14. In these views, the cushion opening has not been cut from molding.
The cushion 14, 214 described above has several advantages. For example, the cushion 14, 214 is structured to alleviate the pressure of the cushion on the patient's face. Also, the cushion, 14, 214 is structured to conform and seal to different patient facial profiles. Further, the cushion 14, 214 is locally compliant.
Although our invention has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the application of the principles of the invention. Numerous modifications may be made therein and other arrangements may be devised without departing from the spirit and scope of the invention. For example, whilst in a preferred embodiment, the cushion includes two membranes, it is also applicable to cushions with one, three or more membranes. Furthermore, the principles of the invention may be applied to a variety of different patient interfaces, such as nasal mask, nose and mouth masks, full-face masks, nasal prongs and nasal cushions. In different cushions, the role of sealing and support structures can be combined into one physical structure. Fingers may be shaped or adjusted to suit the needs of individual patients.
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.
wherein the outer membrane and the underlying membrane each have an inner edge which defines an aperture to receive the patient's nose when the cushion is worn, the inner edge of the outer membrane and the inner edge of the underlying membrane are configured to conform to the patient's face when the cushion is worn, and the underlying membrane is segmented along its inner edge to provide a set of independently flexible finger portion.
2. A cushion according to claim 1, wherein the segmented underlying membrane is structured to provide local compliance.
3. A cushion according to claim 1, wherein the segmented underlying membrane is structured to provide relative movement along its inner edge in conformance with different facial regions in contact with the cushion when the cushion is worn.
4. A cushion according to claim 1, wherein the underlying membrane is thicker than the outer membrane.
5. A cushion according to claim 1, wherein the outer membrane forms a seal with nasal bridge, cheek, and lower lip regions of the patient's face when the cushion is worn.
6. A cushion according to claim 1, wherein the underlying membrane is provided in cheek regions of the patient's face.
7. A cushion according to claim 1, wherein at least two of the finger portions are interconnected by webbing.
8. A cushion according to claim 1, wherein the underlying membrane includes a line of segmentation that extends substantially perpendicular to its inner edge.
9. A cushion according to claim 1, wherein the underlying membrane is reduced or eliminated in at least one of a nasal bridge region and a lower lip region of the patient's face.
a cushion according to claim 1.
11. A cushion according to claim 1, wherein the inner edge of the outer membrane and the inner edge of the underlying membrane both curve inwardly from a side wall in a cantilever manner towards a nose receiving cavity of the cushion.
12. A cushion according to claim 1, wherein the segmented underlying membrane provides a series of independently flexible portions along its perimeter structured to allow the cushion to conform to different patient facial profiles.
the underlying membrane having an inner edge defining an aperture and being divided along the inner edge to form a series of independently flexible finger portions, wherein the inner edge of the underlying membrane is configured to conform to the patient's face when the cushion is worn.
14. A cushion according to claim 13, wherein the finger portions are interconnected by webbing.
15. A cushion according to claim 13, wherein the underlying membrane includes a line of segmentation that extends substantially perpendicular to the inner edge.
16. A cushion according to claim 13, wherein the underlying membrane is reduced or eliminated in at least one of a nasal bridge region and a lower lip region of the patient's face.
17. A cushion according to claim 13, wherein the underlying membrane provides local compliance.
18. A cushion according to claim 13, wherein the underlying membrane is structured to provide relative movement along its inner edge in conformance with different facial regions in contact with the cushion when the cushion is worn.
19. A cushion according to claim 13, wherein the outer membrane forms a seal with nasal bridge, cheek, and lower lip regions of the patient's face when the cushion is worn.
20. A cushion according to claim 13, wherein the underlying membrane is provided in cheek regions of the patient's face.
21. A cushion according to claim 13, wherein the inner edge of the underlying membrane curves inwardly from a side wall in a cantilever manner.
wherein the segmented underlying support structure provides a series of independently flexible portions along its perimeter that are structured to allow the cushion to conform to different patient facial profiles.
23. A cushion according to claim 22, wherein the underlying support structure is an underlying membrane.
24. A cushion according to claim 22, wherein the membrane and the underlying support structure each have an inner edge that curves inwardly from a side wall in a cantilever manner towards a nose receiving cavity of the cushion.
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References: Application No. 2004902979
 Application No. 05
 Application No. 07784697
 Application No. 2003275762
 Application No. 09161984
 Application No. 03810331