BREATHING MASK AND A SEALING LIP DEVICE FOR A BREATHING MASK
20170246412 · 2017-08-31
Inventors
Cpc classification
A61M16/0616
HUMAN NECESSITIES
A61M16/0605
HUMAN NECESSITIES
B29C45/1676
PERFORMING OPERATIONS; TRANSPORTING
A61M2205/0216
HUMAN NECESSITIES
International classification
A61M16/00
HUMAN NECESSITIES
Abstract
A breathing mask includes a relatively rigid shell and an elastomeric sealing lip mounted to the relatively rigid shell. The elastomeric sealing lip has a contact zone configured to bear against the face of the person. The elastomeric sealing lip further includes a nose bridge region, a first nostril region and a second nostril region. The nose bridge region has a first zone of lower load-bearing capability. The first nostril region has a first zone of higher load-bearing capability. The second nostril region has a second zone of higher load-bearing capability. The first zone of lower load-bearing capability has a lower load-bearing capability than the first and second zones of higher load-bearing capability. In addition, the contact zone is configured to pivot about an articulation axis that extends through the first and second nostril regions.
Claims
1. (canceled)
2. A breathing mask configured to be worn by a person and deliver respiratory gas to the person's airways under increased pressure compared to ambient pressure, the breathing mask comprising: a relatively rigid shell; a plurality of fixing devices configured to attach headgear to the breathing mask at fixed locations relative to the relatively rigid shell; and an elastomeric sealing lip mounted to the relatively rigid shell, the sealing lip being more flexible than the relatively rigid shell and surrounding a receiving opening configured to receive at least a nose tip region of the person, wherein the elastomeric sealing lip comprises a contact zone configured to bear against the person's face, wherein the sealing lip is configured so that when the contact zone bears against the person's face, a) a portion of the contact zone at a nose bridge region of the sealing lip bears against the person's nose bridge, b) a portion of the contact zone at a first nostril region of the sealing lip is adjacent one of the person's nostrils c) a portion of the contact zone at a second nostril region of the sealing lip is adjacent the other of the person's nostrils and d) a portion of the contact zone at an upper lip region of the sealing lip bears against the person's upper lip, wherein the nose bridge region comprises a first zone of lower load-bearing capability, the first nostril region comprises a first zone of higher load-bearing capability and the second nostril region comprises a second zone of higher load-bearing capability, the first zone of lower load-bearing capability having a lower load-bearing capability than the first and second zones of higher load-bearing capability, wherein in each of the first and second zones of higher load-bearing capability, the contact zone includes regions of increased elastomer thickness that are thicker than an elastomer thickness of the contact zone in the nose bridge region and the upper lip region, and wherein the contact zone is configured to pivot about an articulation axis that extends through the first and second nostril regions.
3. The breathing mask of claim 2, wherein the upper lip region comprises a second zone of lower load-bearing capability that has a lower load-bearing capability that the first and second zones of higher load-bearing capability.
4. The breathing mask of claim 2, wherein the sealing lip is configured to pivot around the articulation axis by collapsing the nose bridge region of the sealing lip.
5. The breathing mask of claim 4, wherein the sealing lip further comprises a folded over portion configured to facilitate the collapse of the nose bridge region, the folded over portion extending from the first nostril region to the second nostril region by way of the nose bridge region.
6. The breathing mask of claim 2, wherein the sealing lip itself is formed from a transparent silicone rubber.
7. The breathing mask of claim 2, wherein an outside surface of the sealing lip in the contact zone is of a velvety matt finish.
8. The breathing mask of claim 2, wherein the sealing lip comprises a bead that surrounds the receiving opening.
9. The breathing mask of claim 2 further comprising the headgear, wherein the headgear is configured to support the breathing mask on the person's head and maintain the contact zone of the sealing lip in sealing contact with an area surrounding an entrance to the person's airways while maintaining a therapeutic pressure at the entrance to the person's airways, and wherein the relatively rigid shell comprises a central aperture adapted to receive the respiratory gas.
10. The breathing mask of claim 2 further comprising the headgear, wherein the headgear is configured to support the breathing mask on the person's head and maintain the contact zone of the sealing lip in sealing contact with an area surrounding an entrance to the person's airways while maintaining a therapeutic pressure at the entrance to the person's airways, wherein the relatively rigid shell comprises a central aperture adapted to receive the respiratory gas, wherein the upper lip region comprises a second zone of lower load-bearing capability that has a lower load-bearing capability that the first and second zones of higher load-bearing capability, wherein the sealing lip is configured to pivot around the articulation axis by collapsing the nose bridge region of the sealing lip, wherein the sealing lip further comprises a folded over portion configured to facilitate the collapse of the nose bridge region, the folded over portion extending from the first nostril region to the second nostril region by way of the nose bridge region, wherein the sealing lip itself is formed from a transparent silicone rubber, wherein an outside surface of the sealing lip in the contact zone is of a velvety matt finish, and wherein the sealing lip comprises a bead that surrounds the receiving opening.
11. A respiratory system configured to deliver respiratory gas to a person's airways under increased pressure compared to ambient pressure, the respiratory system comprising: a source of the respiratory gas; the breathing mask of claim 2; and a delivery conduit configured to convey the respiratory gas from the source to the breathing mask.
12. The respiratory system of claim 11, wherein the breathing mask further comprises the headgear, wherein the headgear is configured to support the breathing mask on the person's head and maintain the contact zone of the sealing lip in sealing contact with an area surrounding an entrance to the person's airways while maintaining a therapeutic pressure at the entrance to the person's airways.
13. A patient interface configured to be worn by a person and deliver respiratory gas to the person's airways under increased pressure compared to ambient pressure, the patient interface comprising: a relatively rigid shell; a plurality of fixing devices configured to attach headgear to the breathing mask at fixed locations relative to the relatively rigid shell; and an elastomeric sealing lip mounted to the relatively rigid shell, the sealing lip a) being more flexible than the relatively rigid shell, b) surrounding a receiving opening configured to receive at least a nose tip region of the person and c) comprising a contact zone configured to bear against the person's face, wherein a lower load-bearing region of the sealing lip is positioned relative to an opposing region so that the receiving opening is between the lower load-bearing region and the opposing region, wherein a first higher load-bearing region and a second higher load-bearing region of the sealing lip are positioned respectively between the first lower load-bearing region and the opposing region, wherein the first higher load-bearing region is positioned relative to the second higher load-bearing region so that the receiving opening is between the first and second higher load-bearing region, wherein the first and second higher load-bearing regions are configured to bear a higher load than the lower load-bearing region, and wherein in each of the first and second higher load-bearing regions, the contact zone includes regions of increased elastomer thickness that are thicker than an elastomer thickness of the contact zone in the lower load-bearing region and the opposing region.
14. The patient interface of claim 13, wherein the contact zone in the lower load-bearing region is configured to bear against the person's nasal bridge when the patient interface is supported on the person's face.
15. The patient interface of claim 13, wherein the contact zone in the first and second higher load-bearing regions is configured to bear against the person's face adjacent the person's nostrils when the patient interface is supported on the person's face.
16. The patient interface of claim 13, wherein the first and second higher load-bearing regions are configured to bear a higher load than the opposing region.
17. The patient interface of claim 13, wherein the contact zone in the opposing region is configured to bear against the person's upper lip when the patient interface is supported on the person's face.
18. The patient interface of claim 13, wherein the contact zone is pivotable around an articulation axis extending through the first and second higher load-bearing regions.
19. The patient interface of claim 18, wherein the sealing lip is configured to pivot around the articulation axis by collapsing the lower load-bearing region.
20. The patient interface of claim 19, wherein the sealing lip further comprises a folded over portion configured to facilitate the collapse of the lower load-bearing region.
21. The patient interface of claim 13, wherein the sealing lip comprises a bead that surrounds the receiving opening.
22. The patient interface of claim 13 further comprising the headgear, wherein the headgear is configured to support the patient interface on the person's head and maintain the contact zone of the sealing lip in sealing contact with an area surrounding an entrance to the person's airways while maintaining a therapeutic pressure at the entrance to the person's airways, and wherein the relatively rigid shell comprises a central aperture adapted to receive the respiratory gas.
23. The patient interface of claim 13 further comprising the headgear, wherein the headgear is configured to support the patient interface on the person's head and maintain the contact zone of the sealing lip in sealing contact with an area surrounding an entrance to the person's airways while maintaining a therapeutic pressure at the entrance to the person's airways, wherein the contact zone in the lower load-bearing region is configured to bear against the person's nasal bridge when the patient interface is supported on the person's face, wherein the contact zone in the first and second higher load-bearing regions is configured to bear against the person's face adjacent the person's nostrils when the patient interface is supported on the person's face, wherein the first and second higher load-bearing regions are configured to bear a higher load than the opposing region, wherein the sealing lip is configured to pivot around an articulation axis by collapsing the lower load-bearing region, wherein the sealing lip further comprises a folded over portion configured to facilitate the collapse of the lower load-bearing region, and wherein the sealing lip comprises a bead that surrounds the receiving opening.
24. The patient interface of claim 13 further comprising the headgear, wherein the headgear is configured to support the patient interface on the person's head and maintain the contact zone of the sealing lip in sealing contact with an area surrounding an entrance to the person's airways while maintaining a therapeutic pressure at the entrance to the person's airways, and wherein the relatively rigid shell comprises a central aperture adapted to receive the respiratory gas.
25. A respiratory system configured to deliver respiratory gas to a person's airways under increased pressure compared to ambient pressure, the respiratory system comprising: a source of the pressurized respiratory gas; the patient interface of claim 13; and a delivery conduit configured to convey the pressurized respiratory gas from the source to the patient interface.
26. The respiratory system of claim 25, wherein the patient interface further comprises the headgear, and wherein the headgear is configured to support the patient interface on the person's head and maintain the contact zone of the sealing lip in sealing contact with an area surrounding an entrance to the person's airways while maintaining a therapeutic pressure at the entrance to the person's airways.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0044] Further details of the invention will be apparent from the description hereinafter with reference to the drawing in which:
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DETAILED DESCRIPTION OF THE INVENTION
[0071] The sealing lip device which is shown in
[0072] The mask pad 1 includes a sealing lip 3 which extends around the nose receiving opening 2. The sealing lip 3 has an outer surface which is curved convexly in the embodiment illustrated here.
[0073] The sealing lip 3 is of such an arrangement and configuration that it has, of itself, zones of differing load-bearing capability. In the embodiment illustrated here that is achieved by suspension, which is flexible in opposite relationship to the application direction Z, of the sealing lip zone a provided for bearing against the bridge of the nose (see
[0074] In addition thereto, in the region of the zone b1, b2 (
[0075] The higher load-bearing capability is achieved here by zones 4 which are thickened in a pad-like manner and which here advantageously run into the sealing lip 3 in a crescent moon-like configuration. The zones 4 of higher load-bearing capability are respectively supported at a support wall portion 5 which is also comparatively thick-walled. The support wall portions 5 also form an integral component part of the mask pad 1 and are embodied in the form of thick-wall zones of the front peripheral wall which extends in the zones b1, c and b2.
[0076] The degree of flexibility in opposite relationship to the application direction decreases along the sealing lip 3, starting from the zones 4 of high load-bearing capability, to the zenith Q at the side at the bridge of the nose, and then slowly rises to the outer edge point R.
[0077] In the illustrated embodiment, the mounting of the zone a of the sealing lip 3, which is yielding in opposite relationship to the application direction Z, is achieved by means of a folding bellows structure of differing load-bearing capability.
[0078] The differing load-bearing capability is achieved here both by the geometry and arrangement of the bellows structure and also by a particular wall thickness configuration. That wall thickness configuration will be discussed in greater detail hereinafter in particular with reference to
[0079] The mask pad 1 further includes a peripherally extending frame 8 provided with a fixing profile means which is of a complementary configuration to a fixing profile portion provided on a mask base body (not shown).
[0080] The peripheral length of the frame 8 and the configuration thereof around a central axis z of the mask pad 1 are selected in such a way that, in conjunction with a mask base body, the arrangement provides for defined prestressing of the mask pad 1, in particular a tendency towards forward curvature in an outward direction.
[0081] In the illustrated embodiment the wall thickness of the sealing lip 3 is in the range of between 0.6 and 3.2 mm.
[0082] The configuration of the peripheral edge u which borders the nose receiving opening 2 is selected in such a way that there are formed two segments s1, s2 (
[0083] By virtue of the configuration of the peripheral edge u being matched to the convex curvature of the sealing lip 3, it is possible to achieve a deformation characteristic with which an expansion of the sealing lip 3 in the region of the peripheral edge results in a definedly increased surface pressure against the face of the wearer of the mask.
[0084] Provided in a front end center region c is a further zone of reduced load-bearing capability. That definedly reduced load-bearing capability is afforded here by a markedly reduced wall thickness. It is also possible to provide local folding bellows structures or rolling bellows structures in the zone c.
[0085] A particularly preferred embodiment of a sealing lip device is afforded by virtue of the fact that integrated into the same are outlet openings 50, by way of which a defined flow of gas can flow away out of the interior (or plenum chamber) of the breathing mask. Those outlet openings are preferably of an outwardly conically tapering cross-section, as shown in
[0086] Preferably, those outlet openings are initially closed for example by a thin film and are then opened as required for example by puncturing with a needle. As can further be seen from this sketch the mask pad 1 can be mounted to a mask base body 12 by way of a frame portion 8. For that purpose the arrangement preferably has a peripheral bead structure of a crochet needle-like cross-section and with rounded edges.
[0087]
[0088] The mask pad 1 also has in the sealing region of the bridge of the nose a local folding bellows structure 9 which provides for flexible suspension of the sealing lip 3.
[0089] A fold indentation 10 is also provided in the front region c (definition similar to the
[0090] When relatively large tilt angles are involved, here the bellows structure becomes effective as an abutment device and limits in an also elastically yielding manner further engagement of the bridge of the nose into the mask pad 1.
[0091] The bellows structure 9 has the greatest indentation depth tin the region of the end which is towards the bridge of the nose. That indentation depth t gradually decreases to the front end E of the bellows structure 9.
[0092] In the embodiment illustrated here, the end of the bellows structure 9 is of a rounded configuration. Advantageously, provided in the region of the front end E of the fold indentation is a microfold structure e which provides for a more uniform reduction in stresses in the material in that region. That affords improved durability.
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[0094] This embodiment also has a local folding bellows structure 9. The geometry of this bellows structure 9 is so selected that the fold flanks 9a, 9b extend inclinedly relative to each other. Overall in this case also the indentation depth tin the region of the end towards the bridge of the nose is larger than in the other regions. The mask pad 1 also defines an adaptation axis X which extends in the region of the zones c1, b2 and c at the level of the nostrils of the wearer of the mask.
[0095] The mask pad 1 also has a higher degree of flexibility in opposite relationship to the application direction Z by virtue of the suspension arrangement provided here for suspending the sealing lip 3 at a local bellows structure 9, in the region of the zone a which seals off the bridge of the nose.
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[0098] The lowest level of flexibility E of the mask pad 1 obtains in the region b. The highest level of flexibility obtains in the region a which covers over the bridge of the nose and the upper side flanks of the nose of the mask wearer. Obtaining in the region c in addition to the flexibility in opposite relationship to the application direction Z there is also a relatively high level of flexibility in the radial direction.
[0099] The adaptation axis A extends through the zone b of relatively high load-bearing capability. When a predetermined depth of penetration into the mask pad 1 is exceeded, the bellows structure becomes operative in a region d as an abutment device and in that case causes a rapid rise in the pressure force F transmitted by way of the sealing lip 3, as is indicated by the dash-dotted line portion fl.
[0100] The particular mechanical properties of the suspension arrangement for the sealing lip 3 are preferably determined by the wall thickness in the region of the bellows structure 9 and by the indentation depth and the orientation of the bellows flanks 9a, 9b (
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[0102] Beneath the frame 8 there is initially a thick-wall portion 16 which gradually reduces to a first bellows hinge location or vertex 17. That bellows hinge location or vertex 17 is adjoined by a first bellows flank limb 9b. That bellows flank limb 9b has in cross-section zones of differing wall thickness and extends to a bellows inner hinge location 18 defined by a thin-walled zone. The variable wall thickness of the flank limb 9b forms an indentation region or thin wall portion 77 that promotes a hinged motion around the hinge location or vertex 17 (see
[0103] The bellows inner hinge location or vertex 18 is in turn adjoined by a second bellows flank limb 9a which also has zones of differing wall thickness. The variable wall thickness of the flank limb 9a forms another internal indentation region or thin wall portion 78 that promotes a hinged motion around the hinge location or vertex 18.
[0104] Finally, the sealing lip 3 is suspended on the second bellows flank limb 9a at a vertex 79. The sealing lip 3 is here extremely thin-walled in comparison with the bellows structure 9.
[0105] The sealing pad cross-section illustrated here corresponds in qualitative terms to the sealing pad cross-section in the region of the zone identified as al in
[0106] In the course of applying the mask pad to the face of a mask wearer, the sealing lip 3 firstly bears against the face. The bellows flank limbs 9a, 9b are then deflected resiliently inwardly, corresponding to the depth of engagement of the bridge of the nose, as illustrated by the arrows P1 and P2. In the case of particularly deep engagement of the bridge of the nose the inner surface of the sealing lip 3 possibly comes into contract in the region of the zone k with the inside surface, which faces theretowards, of the bellows flank limb 9b. The bellows flank limb 9b in turn can bear on the outside surface, which faces theretowards, of the bellows flank limb 9a.
[0107] The kinematics of the sealing pad suspension configuration will be clear by reference to
[0108] The bellows inner hinge location or vertex 18 also involves an inherently elastic characteristic which is indicated by the spring F2. The loose mounting K2 and the spring F3 are due to the fact that this involves a spatial, ring-like structure which also carries forces in the radial direction.
[0109] The hinge location or vertex 18 is adjoined by the bellows flank limb 9a and the same is adjoined by the diaphragm-like sealing lip 3.
[0110] As illustrated in
[0111] The mechanics of this microsealing lip structure is indicated in
[0112] As can be seen from
[0113] The cross-section illustrated in
[0114] The cross-section illustrated in
[0115] In the regions of the cross-sections illustrated in
[0116] The higher load-bearing capability of the cross-sections illustrated in
[0117] The alternative cross-sections illustrated in
[0118] It is also possible for the bellows structure 9 to be of a thin-wall nature. The kinematics of a structure of that kind is diagrammatically shown in
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[0121] In the embodiment of the mask base body 12 diagrammatically illustrated here, provided in parallel with a respiratory gas passage 24 is a secondary passage 25 by way of which for example pressure measurement can be effected, without reductions in cross-section occurring in that case.
[0122] The tool here is of a three-part construction and includes an upper mold half 26, a lower mold half 27 and a sliding mold portion 28 which can be withdrawn in the direction r3 from the respiratory gas passage 24.
[0123] Although the invention has been described hereinbefore with reference to preferred embodiments in which there is a single fold indentation which does not extend around the entire periphery of the mask pad, the invention is not limited to embodiments of that kind.
[0124] For example it is possible for the bellows structure to be provided with a plurality of fold indentations, of which possibly one or more extend around the entire periphery of the mask pad.
[0125] An example of a corresponding cross-sectional configuration is shown in
[0126] In this embodiment the sealing lip 3 is of a comparatively thick-wall nature. That cross-section is suitable in particular for silicone rubber material with an extremely low Shore hardness.
[0127] The breathing mask shown in
[0128] The sealing pad device 3 is fixed to the mask base body 12 by way of a peripheral bead structure (not visible here). The sealing pad device 3 has a bellows structure which extends locally from the upper end region to an adaptation axis A. Provided in the region of the adaptation axis A on both sides of the sealing pad are zones of higher load-bearing capability which are formed by thicker-walled, spherically curved zones of the sealing pad device.
[0129] For the purposes of fitting the breathing mask to the face of a mask wearer, provided at both sides of the mask are fixing devices 61, by way of which a head band 61a can be coupled to the breathing mask.
[0130] On its top side the mask body 12 is provided with a projection 62 by which the mask body generally is stiffened, thereby affording an improved characteristic in terms of sound conduction through solids.
[0131] Also provided in the region of the top side of the mask body 12 are a plurality of outlet openings 63, 64, by way of which a low-noise, directed discharge flow of partially consumed respiratory air can occur from the interior (or plenum chamber) of the mask. The discharge of that leakage gas flow is promoted by a break-away edge 65 of a spoiler-like configuration. The openings 64 direct the flow substantially in the direction indicated by the arrow P1. The openings 63 which are also provided on the opposite side (not visible here) of the projection 62 open in the directions P2 and P3.
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[0133] The mask pad is of such a design configuration that there is a relief of load in the region of the zones b1 and b2, as a consequence of the internal pressure in the mask which occurs in the context of over-pressure artificial respiration. The surface pressure of the mask pad in the region of the zones a and c is substantially determined by the internal pressure in the mask. In the peripheral direction the sealing pad 1 has a high level of radial stiffness whereby the tendency to oscillation of the sealing pad in relation to alternating artificial respiration pressures is markedly reduced.
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[0135] As indicated, in this case also there is a local bellows structure 66 which ensures improved adaptability to different upper lip architectures.
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[0138] In the embodiment shown in
[0139] In the embodiment shown in
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[0141] The flow paths described with reference to
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[0143] While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.