CN101574553B - Mask and components thereof - Google Patents

Abstract

A comfortable low-leak mask assembly for use with Non-Invasive Positive Pressure Ventilation (NIPPV) is provided to improve patient compliance and/or treatment. The mask system may include headgear having straps that are substantially inextensible and/or micro-adjustable; and/or a mask and/or cushion that includes various structures to allow enhanced/tailored sealing and/or fit at selected locations on the patient's face.

Description

Face shield and its building block

Technical field

The present invention relates generally to the whole face mask for Noninvasive malleation feeder (NIPPA), continuously trachea normal pressure device (CPAP) and feeder.

Background technology

Malleation breathable gas is transported to needs of patients certain interface between machine and patient from feeder.Conventionally adopt the patient interface that is placed on endotracheal pipe and does invasive air feed.In the time of Noninvasive air feed, adopt the face shield of certain form to do patient's interface.

Face shield generally includes a chamber, and this chamber has the cavity of the reception nose being formed by shell or framework.This face shield also comprises conventionally can the facial part of comfortable contact, for example cushion, and this cushion is fixed on the edge of shell or framework.Face shield is conventionally with wearing tool, and for example one group of elastic webbing is fixed on the appropriate location of patient's face.The comfort level of improving face shield, in the time that face shield need to be worn some hours, is particularly the challenge to face shield designer always.

Unless each end user is customized to face shield, because face shape is very not identical, so most of device of face shield is a kind of tradeoff design.A kind of mask designs may coordinate sub-fraction patient group's nose shape (for example Roman nose bone) very much, but another part crowd for example, with difformity nose (short bridge of the nose bone) just can not finely be coordinated.Designing a kind of face shield, to seal well bridge of the nose part be difficulty especially because this region of face be special hold sensible.

Wrinkle on face shield cushion, are wearing the used time for a long time, may make patient's face very uncomfortable.Although use in addition cushion, still can experience by cushion the edge of mask frame, form uncomfortable surface facing to patient's face, when particularly cushion is compressed.

In some cases, face shield is applicable to comprising ventilating slit, this exhaust apertures except other many things and, allow controlled gas leakage to flow out face shield, to prevent from accumulating CO in face shield ₂.For example, the joint portion between face shield and patient skin, also exist carelessness or inward mask leakage unintentionally.Adopt the operation that forms low or zero face shield that is not intended to gas leakage and can improve feeder and particularly respond the middle-and-high-ranking control algolithm of feeder of respiratory air flow signal.

During sleeping, patient may move.In addition, due to for example swelling, during sleeping, the shape of patient's head may change.Although the face shield patient that fits very much in the time starting to connect, because night is this moving, face shield is fitted just not so good subsequently.Prior art face shield generally includes elasticity and wears tool band, and these bands can shorten or extend, or can reconfigure on head, makes face shield get back to the little position of comfortable gas leakage.

The pressure that maintains being provided by feeder can be provided during treating.Some continuous trachea normal pressure (CPAP) devices form a kind of initial ramp from low pressure to treatment pressure.Other CPAP devices can be according to the indication of airflow range, automatic pressure regulation.Other devices can change and maintain pressure within patient's breathing cycle, for example, the higher pressure that maintains is provided in the time sucking, and in the time breathing out, provides the lower pressure that maintains.Elasticity is worn tool band must be configured to be suitable for this pressure that maintains.If resilient band arrangements becomes to be applicable to high pressure, there is such danger, elastic webbing, in the time of low-pressure, stretches tight too tightly and uncomfortable.

Summary of the invention

An aspect of of the present present invention, is to provide a kind ofly for the low face shield of the comfortable gas leakage of Noninvasive feeder, and this face shield can overcome the limitation of prior art face shield.

On the other hand, be desirable to provide a kind of mask system, this system has one or more following features, and wherein each feature contributes to improve patient's compliance and/or treatment: wear tool, comprise not flexible substantially and/or the band that can finely tune; And/or face shield and/or cushion, these face shields and/or cushion comprise various parts, to strengthen/improve sealing, and/or the position of selecting of the patient's face of fitting.

In the following description, adopt following anatomical terms:

Side: from foot to head and exceed on the direction vector of these parts.Nose is in a side of lip and chin.

Tail side: from the head to foot and exceed on the direction vector of these parts.

Anterior: anterior from health rear portion to health and exceed the direction vector of these parts.Nose is in the front portion of ear, and face shield is in the front portion of nose.

Rear portion: on the direction vector pointing to from health front portion to health rear portion.Ear at nose rear portion.

Crown, a plane, is parallel to the plane that comprises head, foot and shoulder summit.From left ear around to the crown again the band to auris dextra be called crown band.

Before and after to face: a face, is parallel to the face through head, foot, posterior spinal and tip of the nose.

Nape: relevant to cervical region rear portion (muscle).

Occipital bone: relevant to the knuckle portion of bone, in this knuckle portion, the muscle at cervical region rear portion enters into the rear portion of skull bottom.

External auditory meatus: earhole.

Kgf: kilogram.

Zygomatic process: the prolapse (strictly saying the main body of zygomatic process) of the cardinal principle half Semen Armeniacae Amarum size of cheekbone.

Inner eye corner: the point of handing near the appearance of eye up and down of the bridge of the nose.

Describe these and other aspects of preferred embodiment below in detail, or can from these explanations, obviously find out these and other aspects.

accompanying drawing explanation

Describe illustrative embodiment in detail below with reference to accompanying drawing, in figure, identical numbering represents identical parts, and these accompanying drawings are:

Fig. 1-5 illustrate the first embodiment of the present invention;

Fig. 5 A and 5B illustrate another embodiment of the present invention;

Fig. 5 C-5H illustrates the another embodiment of the present invention with fine setting property and quick release capability;

Fig. 6-15A illustrates the mechanism and the principle that change belt tension according to the air pressure that flows to patient;

Figure 16-35 illustrate another embodiment of the present invention;

Figure 36-40B illustrates one embodiment of the present of invention, in this embodiment, and both sides that can effective sealing patient nose;

Figure 41-53 illustrate another embodiment of the present invention, can strengthen along patient's nose both sides the framework/cushion of sealing shown in figure;

Figure 53 A-53G illustrates another embodiment of framework, in this embodiment, forms fin and carrys out supporting gasket;

Figure 53 H illustrates additional embodiment of the present invention, and in this embodiment, framework comprises sealing gasket;

Figure 53 I illustrates the present invention's decomposition diagram of embodiment again;

Figure 53 J-53P illustrates an embodiment more of the present invention, in this embodiment, and framework supporting Soft inflated mat;

Figure 54 A-54C is respectively rearview, side view and flat sheet of the bottom view, and the ACLAIM cushion of prior art is shown with the form of exploded view;

Figure 54 D is the cross-sectional view of the cushion of prior art ACLAIM shown in Figure 54 A-54C;

Figure 55 A-55C is respectively rearview, flat sheet of the bottom view and side view, and the cushion assembly of first embodiment of the invention is shown;

Figure 55 D is the cross-sectional view of first embodiment of the invention cushion assembly;

Figure 56 A-56F is respectively rearview, top plan view, flat sheet of the bottom view, side view, rear perspective and the front perspective view of the compliant member of first embodiment of the invention cushion assembly;

Figure 57-57C is curve chart, illustrate respectively first embodiment of the invention, the mechanical property of cushion and ACLAIM cushion;

Figure 58 is the cross-sectional view of the cushion assembly of second embodiment of the invention;

Figure 59 A-59E is respectively front view, rearview, side view, front perspective view and the rear perspective of second embodiment of the invention cushion assembly compliant member;

Figure 60 A-60D is curve chart, illustrate respectively the present invention's the first and second embodiment cushion assemblies,

the mechanical property of cushion, ACLAIM cushion, and compared the mechanical property of three kinds of cushions;

Figure 61 is curve chart, and the present invention's the first and second embodiment cushion assembly operations are under pressure shown;

Figure 62 is the perspective view of third embodiment of the invention cushion assembly;

Figure 63 A-63E is respectively front view, rearview, side view, front perspective view and the rear perspective of third embodiment of the invention cushion assembly compliant member;

Figure 64 A-64E is respectively front view, rearview, side view, front perspective view and the rear perspective of third embodiment of the invention cushion assembly retainer;

Figure 65 is the cross-sectional view of fourth embodiment of the invention cushion assembly;

Figure 66 is the cross-sectional view of fifth embodiment of the invention cushion assembly;

Figure 67 is the cross-sectional view of sixth embodiment of the invention cushion assembly;

Figure 68 and 69 illustrates embodiments of the invention, in this embodiment, and rigidity that can selectively changing cushion;

Figure 70-79 illustrate other embodiment of cushion of the present invention;

Figure 80 illustrates the cross-sectional view of yet another embodiment of the invention;

Figure 81 is the relaxation curve being suitable for as the foam material of all embodiment compliant members of the present invention.

the specific embodiment

Detailed description below the present invention comprises openly many different parts that are applicable to the various embodiment of face shield assembly.It should be understood that to any parts of embodiment explanation can with one or more parts couplings in another embodiment.

Wear tool

A. non-retractable band

Fig. 1-5 illustrate an embodiment of mask system, comprise face shield assembly 15 and wear assembly 20.As shown in Figure 1, wear assembly 20 and comprise many bands, these bands are constructed to and are configured to mainly to surround patient's head.These bands are connected in face shield assembly 15, thereby can be with respect to patient's facial fixed visors assembly 15.Only, as an example, face shield assembly 15 is shown, to illustrate the use of wearing assembly 20.This face shield assembly 15 can replace with any applicable breathing mask, as those of ordinary skill can be found out.

In order to make face shield assembly 15 in position, wear assembly 20 utilize before and after to being with 25 and level band 30.This level band 30 horizontal arrangement substantially, and encase the surrounding of patient's head.Each end 31 of each level band 30 is connected in face shield assembly 15.In the following detailed description, the configuration between level band 30 and face shield assembly 15 is described.This level band 30 preferably just in time passes the bottom of each ear, and the cushion region that enters skull bottom through musculi colli, and this region thing total use 36 in Fig. 2 represents.

Front and back are positioned at the terminal of level band 30 substantially to the rearward end 40 with 25, thereby are positioned at the postmedian region of patient's head.As shown in Figure 1, in the front and back of patient's head Background Region to being quite wide with 25 width, be for example before and after an approximately twice to 25 remainder width.This surperficial degree increase is favourable, because it contributes in the time that pressure change or belt tension change, prevents that this band from strangling the rear portion very blubbery or very soft into patient's head.Certainly, being with 25 should be too not wide and/or very thick, makes it become uncomfortable.Such as BREATHOPRENE of the most handy nice and cool material of this band ^tMmanufacture.

The skull summit that general use 45 represents, to being with 25 for example to stretch out and stretch out from rearward end 40f from level band 30, is crossed in front and back, and substantially crosses the general forehead (seeing Fig. 2) with the numbering 50 patient's heads that represent from inner side.These front and back are to having the front end 55 that is connected in face shield assembly 15 with 25, as described in detail below.

Wear assembly 20 and preferably include a pair of crown band 35, before and after this band makes, couple together to band and level band 25 and 30.The upper end 60 of each crown band 35 is connected in the front and back on close patient's head summit 45 to being with 25, each crown band 35 for example stretches out from upper end 60 from this summit 45, from side direction and below cross head, and from the positive front portion of each ear and under, be connected in level band 30 in the lower end 65 of crown band 35.

Each lower end 65 of crown band 35 is connected in level band 30 by bind and/or bonding agent.Or, level band 30 can with one or more buckle portion parts be connected in crown band 35 and/or front and back to be with 25 the two, this buckle portion part can regulate between one or more band portions.Or one or more bands unitary piece of material of wearing assembly 20 forms.

In order to keep safety and the comfortableness of face shield assembly 15, the band of wearing assembly 20 is preferably formed as not flexible substantially.In other words, with some flexibilities, but these bands preferably can not significantly stretch.These bands have enough large toughness or rigidity, thereby can keep its shape.The imagination material of making band comprises polrvinyl chloride (PVC), leather, polypropylene, or polyurethane.Certainly, also can use other materials.For example, the other materials considering appropriate can be the strap that intensity is large, and these bands also can consider to be lining with felt materials, and to increase patient's level of comfort, other variation comprises perforation or knockout, so that by these band heat radiations.

B. the fine setting of band

1. the first embodiment

With reference to figure 1, preferably will wear by this way assembly 20 and be connected in face shield assembly 15, making can be with respect to the position with adjusting range shade assembly 15 of wearing assembly 20.Face shield assembly 15 comprises frame assembly 70, forms cushion 75 interface or that contact with patient with patient and is inserted in frame assembly 70 the cushion supporting member 80 between cushion 75.Cushion supporting member 80 comprises that hole (not shown) utilizes this hole forced air can be transported to the compression chamber of face shield assembly 70, and this forced air is transported to patient's trachea.Conventionally ell 85 is loosely connected in the hole of cushion supporting member 80.This rotation ell comprises the connector 86 unclamping fast, and this connector is connected in air delivery pipe (not shown), and this carrier pipe is connected in again for example source of the gas (not shown) of air transport device.

Frame assembly 70 comprises the chassis 95 (clear illustrating in Fig. 3) with one or more cross members 100.These cross member 100 supporting extension arms extension components 90, this extension component is connected in again front and back to the front end 55 with 25.These front and back have screwed part 105 to the front end 55 with 25, and the receiver hole 91 that this threaded portion forms through extension component 90 illustrates as Fig. 1 and 2 is clear.Nut 110 can rotate on threaded portion 105, thereby can regulate the distance between extension component 90 and patient's forehead 50.Therefore, tension force that can fine tuning band, particularly 25 described above to being with in front and back, when non-retractable material is made substantially.

Fig. 3 illustrates the front view of face shield assembly 10.As can see from Figure 3, chassis 95 comprises many finger member of stretching out from chassis 95 115.The finger member 115 of descending most on 95 each sides, chassis comprises hole 120, and this hole is constructed to and can receives the screwed part 105 stretching out from level band 30 each ends.Nut 110 can be fixed on threaded portion 105 with screw thread, make can fine tuning face shield assembly 15 and patient's face between distance.Therefore, these can be with the tension of very high accuracy, makes in high pressure limit, to act on facial power apt to 40cm water column given approximately 2.

As Fig. 3 and 4 clear illustrating, this threaded portion 105 is essentially rectangular cross section, comprises two quite flat sides and two sides with threaded portion.The shape in hole 91 and 120 and the shape of threaded portion 105 are complementary.For example, hole 91 and 102 has rectangular shape substantially, in the time of adjusting nut 110, can prevent that threaded portion from rotating thus.Although not shown, the end of threaded portion 105 also comprises the parts with slot, thereby contribute to prevent the rotation of threaded portion 105.

Fig. 4 is side view, the clearer connection illustrating between each level band 30 and frame assembly 70.In addition, Fig. 4 illustrates, each finger section 115 is for example connected in the lateral part 96 and 97 on chassis 95 movably rotationally.In this specific example, two, top finger section 115 is connected in cross bar 125, and two finger section 115 of bottom are connected in similar cross bar 130.Therefore, two top fingers on each side, chassis and two bottom fingers respectively can be harmonious move, see that from the distribution viewpoint of power this is favourable.But should consider, each finger can be independently movable with respect to the cross member 96 and 97 on chassis 95.

In this embodiment, the threaded portion 105 stretching out from each level band 30 ends 31 is through the receiver hole 120 that is formed on 115 formation of two of bottoms finger section.Like this, in the time of fastening nut 110, will be stretched in any the relaxing on level band 30.After all lax of tensioning, further tightening of nut 110 will cause two of right-hand side bottoms finger section 115 to rotate clockwise (watching from above) with respect to cushion supporting member 80.Two of left-hand side bottoms part is rotated counter-clockwise direction in the time watching from above.Cushion supporting member 80 can deformation in the side part 82 of at least close finger section 115.Due to this deformation, this side part 82 can apply power to the appropriate section in cushion 75, thereby compresses the both sides of patient's nose.

As shown in Figure 4, cushion 75 can form one by for example finger 115 with cushion supporting member 80 flexible or can deformation, thereby better mates the profile of various faces.Need compromise manufacturing between very soft dead-soft cushion supporting member, very soft is for the face of fitting better, dead-soft cause face masks volume for example, with each air-breathing undue change (being greater than 20 milliliters) this to make to measure trend volume very difficult.The conventional silicone rubber of about 1-3mm thickness is suitable.

Fig. 5 is rearview, and face shield assembly 15 is shown, in this assembly, can be pressed in a side part 82 of cushion supporting member 80 by hand push in two, the top finger section 115 in patient's face left side.The power that two, top finger section 115 acts on cushion side part 82 can make cushion 75 that deformation occurs, and makes it can push the side of nose, can receive thus difform nose, and strengthen the sealing property of cushion 75.

In Fig. 1-5, can making finger rotate and push simultaneously together with deformation behavior of two sides 82 of the tension force of band and supporting member 80, can push both sides and a part of patient's face of nose thus.Therefore, utilize the independently rotation can the irregular face of adapted shape.This also contributes to active force uniform distribution, on face, to unclamp thus the region of high contact force.

Fig. 5 illustrates the result that increases top bar (not shown) tension force, and this increase of tension force causes oppressing patient's nasal bridge region.For the treatment of two pressure, this is useful especially, make under low-pressure, and the only very low power of effect, and under high pressure, act on high power, this contributes to improve level of comfort and sealing.Wear tool with non-elastic material manufacture, contribute to prevent " piston action " of face shield on face, that is, during two pressure therapies, in the time of high pressure, lift away from face and/or in the time of low pressure, enter face.

In the embodiment shown in Fig. 1-5, be formed in two top finger components on 95 each lateral parts 96 and 97, chassis and be expressed as and be connected on arbitrary tape member of wearing assembly 20.But the location of this top band portion can be as shown in imaginary line in Fig. 2 135 and 140.Specifically, imaginary line 135 represents that top band portion is connected in the state at crown band 35 middle parts.Imaginary line 140 represents that top band portion wearing the each side of tool and be connected in the state of level band 30.

2. the second embodiment

Fig. 5 A and 5B illustrate another embodiment of the present invention, and in this embodiment, level band 30 comprises the first pontes C1, and this coupling part is optionally connected in the second coupling part C2.This second coupling part C2 is fixed on bottom band LS and top band US.Upper and lower band LS, US can be tensioned to them and be pressed on the degree of framework 70 lateral parts 82, can on cushion 75, apply thus inside power, thereby in the both sides of side seal patient nose.This upper and lower band LS and US are fixed on framework 70 (as shown by arrows) adjustablely, thereby can locate better the region of internal force effect.In this embodiment, side part 82 use of supporting member 80 can be made by shape-changing material, and summit is more rigid.

3. the 3rd embodiment

Fig. 5 C-5H illustrates an embodiment more of the present invention, and in this embodiment, governor motion can coarse adjustment and the tension force of fine tuning head band.Fig. 5 C illustrates whole face shield assembly, and this assembly comprises mask frame 800, and this framework has ell 805, and this ell comprises the anti-valve 810 suffocating.Fastener 815 is unclamped in configuration fast, so that patient very takes off and wears tool to property, as described in the U.S. Patent application No.10/235846 of No. 6 propositions of in JIUYUE, 2002, this patent application is whole to be included in this article as a reference.Fig. 5 D illustrates the quick tripping-gear in local open position, and Fig. 5 E illustrates the quick tripping-gear of opening completely.

With 820 a pair of strap end portion 820A and the 820B that comprise for face shield assembly being remained on to patient's head.For example 820B of one of them strap end portion can be connected in by for example groove 821 one end of the mask frame that is positioned at fixed position, can avoid thus the length variations with 820, repeat take off or relay on when face shield assembly, may there is this length variations.Another strap end portion 820A configures and is constructed to adjustable.Certainly be all adjustable with two ends of 820.Curved bel 820, makes strap end portion 820B through groove 821, forms an available rivet 822 or the fixing ring of other securing members.

Can carry out accommodation zone 820 by configuration adjustment assembly 825.Specifically, as shown in Fig. 5 F, this adjusting part comprises rectangular prism 830 substantially, and this prism has the band receiving slit 835 through its whole length.This groove has the opening 840 being presented on prism end face.This prism has upper part 836, lower part 837 and screw rod 845, illustrates as Fig. 5 G is clear.On this, part and lower part 836 and 837 can take to be suitable for the primary importance of coarse adjustment strip length, strap end portion 820A can be pulled through to the length of groove 835 in this position.Be suitable for the second position of fine tuning, on this part and lower part 836,837 in connection with together with, screw rod 845 is contacted with strap end portion 820A, thereby anti-leukorrhagia stopping is by groove 835.Screw rod 845, in the time rotating, will make strap end portion 820A move, thus tensioning or loosen and wear tool.On this, part and lower part 836,837 can translations by groove and pin part 841,842, thereby screw rod 845 is moved, and reach or the contacting of disengaging and groove 835.This screw rod 845 has an end with the first gear parts 850 that extends through prism 835 length.As shown in Fig. 5 H, the first gear parts 850 engages the second gear parts 855 with right angle again.The second gear parts 855 has the cylinder button 860 being fixed in the above.Rotate this cylinder button 860 and just can rotate the second gear parts 855, drive thus the first gear parts 850, thereby drive screw 845.Depend on rotation direction, band or pull-out or push this groove, length that thus can fine tuning band.

C. the pneumatic pad of inflatable gallbladder-gas bag and occipital bone

1. the first embodiment

With reference to figure 1, shown in figure, wear assembly 20, shown in figure, comprise the inflatable gallbladder of special shape, this gallbladder will be called along for example wearing assembly 20 front and back to " gas bag " 145 with 25 configurations.This gas bag 145 be configured to can be in the gamut of mask pressure by the relatively constant face that is used in patient with masterpiece.This gas bag 145 is a kind of active components, can use gas work done, thereby under higher pressure, face shield is drawn to face.Gas bag 145 is by the pressure communication in silica gel tube 150 and the face shield of minor diameter, and this silica gel tube is connected in the gas inlet-outlet of this assembly on face shield assembly 15 or close.In this example, this pipe 850 is configured on ell 845, before and after at least form by bleed pressure is local by gas bag 145 to the belt tension with on 25, this tension force can make under elevated pressures to be with that tensioning more/more multidigit is moved, and under lower pressure, can make to be with not too tensioning/or less displacement.

Although gas bag 145 is expressed as to preferred embodiment, can adopt other mechanisms to obtain the variation of belt tension/displacement, these mechanisms comprise power driven system and mechanical system.In the time that mask pressure increases, the increase of gas bag pressure is inflated to more as spherical gas bag, makes thus to shorten before and after its, thereby pull strength is backward acted on cantilever 90, makes thus face shield be pressed in more reliably on face.

As first approximation, the direction being produced by gas bag or cantilever 90 power is backward proportional to mask pressure.In the time that nut 110 is tightened, its proportionality constant is larger, makes under certain mask pressure, and this gas bag can more easily elongate.Therefore, gas bag 145 can be seen a kind of compensation mechanism as, if regulate like this this mechanism, make under a pressure, and mask seal, face shield will be at all pressure lower seals, and by the air pressure in balance face shield always.

When pressure increases Δ P, gas bag is expansion Δ V, the Δ V Δ P that does work thus, and the effect of counteragent thus, pulls back a segment distance by the junction point on cantilever 90 91.

Although only form gas bag 145 on the band of top, also can comprise and form other gas bag on level band 30 at remaining band.But in this embodiment, on the band of bottom, do not add any gas bag 145 because patient's lower jaw and lower lips naturally move towards to form waveform, this situation is similar to bag 145 effect to a certain extent, thereby within the scope of whole operating pressure, in this region, form good motion.In other words, at the bottom of the sealing mechanism of mask top and face shield, General Logistics Department's sealing mechanism is different.For face shield bottom, mask designs personnel can rely on patient's lower lips and lower jaw to pressurize, and at the top of face shield, adopt different mechanisms, because the face structure of nasal bridge region is bone, very hard.

2. the details of gas bag

Illustrate and gas bag 145 describe below referring to Fig. 6-15A in general sense, these explanations have been described in more detail the more specifically principle of gas bag.

Gas bag 145 is rubber cuboid light-wall pipes that for example silicone rubber is done, and can get up along two side wrinkle, then gets up at the end-enclosed of non-wrinkle.The headband that the closed end of non-wrinkle is inserted into face shield assembly 15 for example before and after to being with in 25.Fig. 6 and 7 illustrates that gas bag 145 is in relaxed state, wherein there is no pressure or there is no pressure completely, and for example, during patient exhales, and Fig. 8 and 9 is illustrated under treatment pressure for example at the gas bag 145 of patient's intake period.For two air pressure feeders, patient is exposed to relatively high pressure in intake period, and during exhaling, is exposed to lower pressure, gas bag 145 is inflated to pressure p will make gas bag 145 shorten or broaden, and therefore head band 25 will be drawn tightlyer.

Suppose that gas bag 145 is longitudinally relaxing below, and be laterally rigidity, make it can under all pressure, can keep above-mentioned flat-top lateral part.During fabrication, can by for example by rigid rod transverse bonding on top surface and basal surface, or top surface and basal surface are molded as and have horizontal vallum, and/or between the flexible wall of left and right with inner system silk, obtain this flat-top lateral part.In fact, basic conception and following explanation are to obtain loosening roughly without these retrofits.

In the example of Figure 10, gas bag 145 has width W and inflation height 2h.Telescopic side is assumed that and applies the power of ignoring, and is not included in calculating.The power of bringing is f.In Figure 10, gas bag 145 is laterally cut in half, and a pair of rigid plate is fixed on this tangent line, and one of them rigid plate represents by numbering 155.Connect this two plates by rigid rod 160.Power on rigid rod 160 is also f.

Suppose that on the band of top, axial surface tension force (power/unit length) is t.Because not variation in time of assembly, so act on power on visible plate 155, it makes a concerted effort to be necessary for zero.These power comprise act on the left side power 2tW, act on the power 2pWh on the right and act on the power f of the right on rigid rod 160:

2tW＝f+2pWh (1)

If for p > 0, there is not on tape any surface tension, the top surface of gas bag 145 and lower surface will together with form cylinder (θ=pi/2).When being with 25 to do the used time being subject to tension force, surface is fan-shaped by becoming the cylindrical incomplete symmetry that two radiuses are r, as shown in the cross section of Figure 11.

The intersecting lens of two surfaces and band is positioned at poised state, on it, does not act on any clean power.Because it is incoherent exceeding the surface of the gas bag 145 of junction point, so all the other cylinders that can be r with radius are replaced the entirety that exceedes junction point.

The cross section of top or lower surface is circular arc, and its radius is r, and is 2 θ facing to the angle in the center of circle.

According to simple geometric figure, the angle between gas bag 145 top surfaces or basal surface and the extension line of band is also θ, as shown in figure 12.Because be zero at the net effort of coupling part, so we obtain:

f＝2Wt cos(θ) (2)

Can obviously find out from Figure 12, another constraint equation is:

h＝r(1-cos(θ)) (3)

Finally, if gas bag 145 has length L of evening up (distance between band), the girth of circular arc is:

L＝2rθ (4)

Therefore there are four company's cube journeys, five unknown number p, h, t, f and θ, and two constant W and L.The solution of f is:

f＝pWLcos(θ)/θ (0＜θ＜π/2) (5)

Note following characteristic:

(i) if gas bag even up, i.e. θ → 0, any normal pressure will produce infinitely-great power;

(ii) if θ=pi/2, gas bag is cylindrical, f is zero for all p.The characteristic that neglects flexible side, W and L play same purpose in the generation of power.The two one of double to double exerting all one's strength.

The power producing is with the length variations of gas bag 145.As can be seen from Figure 11, the distance x at gas bag two ends is determined by following equation:

x＝2rsin(θ) (6)

The r replacing in equation (4) can obtain:

x＝Lsin(θ)/θ (7)

Notice again:

f＝pWLcos(θ)/θ (5)

List table 1 with equation above.The second row of table 1 illustrates the gas bag length " x " (seeing Figure 11) as regular length L percent to various angle θ.The third line represents the power " f " (seeing Figure 10) producing, and this power is expressed as the percent of pressure p, width W and regular length L product.

Table 1

θ (degree)	x/L＝sin(θ)/θ	f/pWL＝cos(θ)/θ
			0	1.00	Infinitely great
10	0.995	5.64
			20	0.980	2.69
30	0.955	1.65
			40	0.921	1.10
50	0.878	0.737
			60	0.827	0.478
70	0.769	0.280
			80	0.705	0.124
90	0.637	0.000

figure 13 draws the function curve that power f (being expressed as the percent of pLW) changes with length x (being expressed as the percent of regular length L).

The θ angle differential equation (5) and (7) are obtained:

df/d＝-pWL[sin(θ)/θ+cos(θ)/θ ²] (5a)

dx/dθ＝L[cos(θ)/θ-sin(θ)/θ ²] (7a)

Removing (5a) (for 0 < θ=pi/2) with (7a) obtains:

df/dx＝pW[cos(θ)/θ+sin(θ)]/[sin(θ)/θ-cos(θ)] (8a)

In the limit (empty gas bag) of θ → 0, denominator becomes 1, and molecule becomes infinity, so spring has infinitely-great positive rigidity.For the gas bag (θ=π/4) of permitting gas completely, rigidity is positive 4pw/ π).Table 2 has added the rigidity of last table.

Table 2

θ (degree)	Distance (maximum percent) between band	The power (coefficient of pWL) producing	Rigidity (coefficient of Pw)
				0	1.00	Infinitely great	Infinitely great
10	0.995	5.64	592
				20	0.980	2.69	78
30	0.955	1.65	25
				40	0.921	1.10	11
50	0.878	0.737	6.2
				60	0.827	0.478	3.9
70	0.769	0.280	2.8
				80	0.705	0.124	2.1
90	0.637	0.000	1.57

Example

Actual gas bag has:

W＝5cm＝0.05m；

L＝6cm＝0.06m；

p＝20cmH ₂O＝1960N/m ²～2000N/m ²。

If gas bag 145 is partial inflation, and remain between two rigid support, the tension force of band increases with pressure is linear.

For any given geometry, the power of generation is proportional to regular length and the extension of gas bag.

For any given pressure, in the time that gas bag is positioned at its static length, the power producing, for infinitely great, then declines very soon.

As an example, be connected in 20cmH ₂the gas bag of the 6cm length × 5cm width of O pressure, in the time shortening 0.5cm, produces the power of about 0.633kgf, in the time shortening 1.0cm, produces the power of about 0.300kgf, while shortening 1.5cm, produces the power of about 138g.

This power has the result of very strong dependence to be to length, strains headband will make, under setting pressure, can produce the power of any requirement with screw.

Face shield assembly 15 utilizes two to remain on three points of face with 25 and 30.By face shield assembly 15, to be constructed to base be 12cm and be highly the isosceles triangle of 12cm, removes two less trianglees of formation in the bottom corner angle that are highly 2cm and base 2cm.Therefore, the gross area of face shield is 70cm ².

At 20cmH ₂under the pressure of O, air pressure will apply the power of 1400g, and at 5cmH ₂under O pressure, the only power of 350g will be applied.Can to suppose, in order sealing, need to apply than the power of this power high 30%, or apply the power of 1820g.

With reference to Figure 15, supposing 1) centre of moment C is positioned at the position of 4.5cm above, face shield bottom, or is positioned at the position of the 7.5cm below top; 2) bottom band is connected in the position of about 3.5cm above, face shield bottom, or the place of 1cm is fixed below the centre of moment; 3) band about 15cm place on the centre of moment in top is connected in a stock.

Because the connection of bottom band is than approximately 15 times of close centre of moments of the connection of top band, so bottom band bears 15/16 of load, the power that only leaves 100g is supported by top band.

On the band of top, there is the wide gas bag of 6cm length × 5cm.This gas bag is connected in face shield with pipe 105.In the time that its length is reduced to 4.35cm, this gas bag is at 20cmH ₂under O pressure, the power of 100g will be produced.Under this length and pressure, the rigidity of gas bag is 0.232kg power/cm.

Suppose that gas bag 145 and elastance are E _sTRAPtensilely wear tool band series connection.The free end of tensile bag and gas bag is fixed.The elastance of total system adds the elastance that makes to wear tool the elastance of gas bag.

For example, suppose 5cm wide × the long gas bag of 6cm and elastance are 10cm/kgf gets well the tradition of washing

headband is installed in series.Gas bag is at 20cmH ₂when O pressure, be 4.35cm length, and apply the power of 0.1kg, as previously mentioned.

Under this condition, the spring constant of gas bag is 0.232kgf/cm, so its elastance is 4.3cm/kg.Therefore its (part) elastance of total system is 14.3cm/kg.The elastance of whole system is by the control of tradition band.

As another example, from 5cm wide × the long gas bag of 6cm, pressure is 20cmH ₂o.Therefore, length is still x ₀=4.35cm, the power f of generation ₀=100g.This gas bag still with elastance be 0.1kg/cm band, i.e. spring constant K _strapthe band series connection of=10kg/cm, next step is to determine at pressure decreased to 5cmH ₂occurrence when O.

The relation equation of the power being produced by extending band and gas bag length x is:

fstrap＝f ₀-Kstrap(x-x ₀)

This relation is drawn in by gas bag at 20cmH ₂o and 5cmH ₂o pressure produces on the figure of power, and we obtain Figure 15 A.

Wearing tool will shrink, and make gas bag be elongated to about 4.8cm from 4.35cm, and the tension force of band is not to be reduced to 0.05kg from 0.1kg on request, but be reduced to only about 0.55kg.

In the time there is no gas bag, the unwanted belt tension being supported by the bridge of the nose is 75g.During with the headband of non-retractable or rigidity substantially, the correct gas bag regulating can drop to zero by this power conventionally.But for very dark headband, unwanted belt tension is 45g, or half during without gas bag is more.

2. the second embodiment

Figure 16-35 illustrate another embodiment of the present invention.

Total with numbering 410 face shields that represent with wear assembly shown in Figure 16-18, be expressed as the state being worn on model head.This mask and headgear assemblies 410 comprise face shield assembly 412, wear tool 414 and form is the inflatable gallbladder of the pneumatic pad 416 of occipital bone, and this inflatable gallbladder is connected in wears tool 414, to regulate the joint of wearing tool 414.

Face shield assembly 412 comprises mask body assembly 418 and mask frame 436 (will describe in detail) below, and this mask frame plays supporting member or " skeleton " effect to face shield body assembly.This mask body assembly 418 when watching, is roughly triangle, as shown in figure 27 above.

In a kind of preferred form, mask body assembly comprises part 420 and the main part 422 that contact is facial.The part 420 of the contact face of mask body assembly 418 is to provide a kind ofly meticulous connect airtight and does not cause pain, uncomfortable or make skin injured.Specifically, contacting facial part 420 is designed to seal around the bone parts of nose.For fear of injured skin, if the average pressure that contact facial parts 420 acts on face without any a part is greater than facial capillary tube mean blood pressure (being conventionally about 20mmHg pressure), this is best.

In general, contact facial parts 420 is generally shaped to the height that is pressing both sides (be pressed in nose cartilage above) that nose dyes bone and be highly positioned at inner eye corner.Contact facial parts 420 is formed on the inside sealing member of both sides forming surface of bridge of the nose bone.But contact facial parts 420 is designed to do not pressing the both wings of nose, method is directly to pressurize at cartilage, or indirect nigh software component pressurization.In addition, contact facial parts 420 does not preferably contact eyes, eyelashes, or the tear stains mechanism on angle within the eye.

The contact face part 420 of mask body assembly 418 comprises some main form parts, and these parts can be seen from Figure 27-31.Form breach 424, to receive the bridge of the nose (nasion).Form teat 426, to coordinate the front of upper frontal bone prominent.Form the second breach 428, to receive buccal (the upper volume that is cheekbone is prominent).In addition, form the second teat 430, forming the 3rd breach 431 to receive mandible arch to connect airtight jowl.

Make at a kind of preferred form contact facial parts 420 of polyurethane foamed materials, cover silica gel " top layer " or sheet above.If silastic material is the material of the softest (the hardness minimum) that can make and there is no again viscosity or decortication characteristic, is best.Conventionally the outer polymer adhesive of using of silicone rubber is on foamed materials, wrinkling with respect to foamed materials to prevent this skin.

The main part 422 of mask body assembly 418 supports ell 430, anti-valve and the breather suffocating.This main part can quite optionally make 418 deformation of mask body assembly or bending with respect to the framework of face shield assembly 412 436, and this main part also plays location and constraint mechanism effect, to prevent framework slippage.At this mask body assembly 418 shown in the plane graph of Figure 33 A and the sectional view of Figure 33 B, in a kind of preferred form, this main part 422 use silicone rubber are done, and together with contact face shield part 420 molded forming, and in abutting connection with face shield contact portion 422.

Face shield assembly 412 comprises increased pressure board or framework 436, and this framework can be added in the active force of wearing tool on cushion.Illustrate as Figure 21 is clear, this framework is generally triangle, comprises that bottom points 438, side part 440 and top divide 442.This framework 436 is that elasticity is flexible, makes framework 436 can wrap in the surrounding of the upper and lower volume of patient and nose.The bottom of framework 436 divide 438 and top divide 422 general such manufactures, make softer than relatively hard side part 440.Top is divided with bottom and is divided 442 and 438 decision longitudinal axis L, and this framework 436 can be around this axis generation elastic bending, as shown in Figure 32 and 35.This elastic bending of framework 436 can make face shield assembly 412 coordinate more accurately various face shape.For example, the same face parts 412 can be used for the having elongated face patient of (so-called Hubei Province fish shape face), also can be for having on the patient of flat wide shape face (so-called panda face).

The bottom of framework 436 divide 438 be generally " C " shape or the heart moon shape, this top divide 442 be generally Darts form or herringbone.

Soft top divide 442 and bottom divide 438 can make of the thick polypropylene board of the wide 1mm of about 2cm.Each side part 440 can be made of the aluminium flake of a pair of 100mm × 20mm × 1mm same shape.This framework 436 can with four rivet rivetings together, or can combine with for example Method for bonding of other known methods.

In Figure 32, the framework 436 illustrating separately comprises the fork-shaped bracket 444 being contained in each side part 440.Each bracket 444 use aluminum or other material making of rigidity substantially.Have some holes 446 along the length of side part 440, these holes are suitable for receiving bolt, thus analog bracket 444.Bracket 444 can regulate by the method for unclamping bolt, adjusting angle and bolt on respect to the angle of side part 440.By can be along the position of side part bracket 444 in different holes by being bolted to.Two brackets 444 are not necessarily contained in identical relative position along side part 440.Like this, can revise a little for any unsymmetry of patient's face.In each side part, fix a bracket 444.This bracket 444 is suitable for receiving and engaging the nut 448 of face shield tool 414 screw rods 450.

In addition, framework 436 comprises the liner of wedge shape.In use, this liner in operation, be fixed on the side part 440 of mask body assembly 418 and/or top divide 442 and facial contact portion 420 between.It is thick that this liner is about 1-2cm at top, is reduced to gradually zero in the position of about face shield half.In addition, the thickness of this wedge is reduced to zero gradually from external-to-internal.This wedge is generally made of incoercible material.This wedge is used in additional masterpiece at the top of mask body assembly 418, thereby is conducive to sealing.In addition, this wedge, at the both sides of nasal bone compressing face shield body assembly 418, adds larger pressure at the outward flange of mask body assembly 418 than inward flange.

Wearing tool 414 comprises with assembly 452, the pneumatic pad 416 of occipital bone or other sensitive adjustable tension parts and a pair of threaded rod 450 that is connected in face shield assembly 412.In general, face shield tool 414 is constructed and is configured to, and makes from face shield assembly 412 to the force vector that originates from face shield assembly 412 aerodynamic centers of wearing tool 414, mid point that should be through the meatus acusticus internus of left and right.

As Figure 22 and 32 clear illustrating, band assembly 452 comprises bottom occipital bone band 456, crown band 458 and a pair of and a pair of auricle 460.In this embodiment, with the 456,458, the 460th, entirety is worn the end of assembly.But in other embodiments of the invention, these bands can be the single bands that in position selectivity links together.Can make of the polypropylene board of soft for example 1mm of general non-retractable plastics with 456,458,460, these plates froth bed for selectivity, felt become or other cushion material cover on a side or two sides, to increase comfortableness, because these are to form with soft non-retractable material, so with 56,58,60 shapes that can coordinate patient's head, but in the time being subject to 2kgf tension force, the elongation of these bands generally can not exceed 1-2mm.

Bottom occipital bone band 456, below occipital bone, but passes through on musculi colli, and width is about 4cm.The string of a hat 458 is crossed the bizet of patient's head.Auricle 460 is constructed to can be partly or fully around ear.This auricle 460 can form with the material of oval ring, the about 2cm of width, and be lined with the felt of skin contactable.This felt should surmount this vesica piscis a little, strangles in the basal part of the ear preventing.

The screw rod 450 of a pair of rigidity stretches out from auricle 460.In one embodiment, this screw rod is made of the thread nylon bar of 5mm.This bar 450 is configured to them can approach external auditory meatus in operation, and stretches out forward on approximately horizontal plane.Configuration cylindrical nut or handwheel 468, this handwheel is contained in along on each bar 450 with screw thread, and can move along the length of each bar.Each nut or handwheel 468 are suitable for being releasably engaged in the bracket 444 being contained on mask frame 436, as shown in Figure 16,17,19 and 20.This bar 450 utilizes rotating connector 470 to be connected in to wear the auricle 460 of tool 414, as shown in Figure 19,23 and 24.(the first and second positions of rotating connector 470 are shown in Figure 24 and 25).Like this, just, relative angular position that can adjusting rod 450.Along threaded rod travelling nut 468, can accurately regulate framework 436 and wear the tension force on tool 414.This configuration also forms quick back-off assembly.Because framework 436 comprise soft bottom divide 438 and top divide 442, so regulate they, find patient is more suitable for cooperation time, framework by according to nut 468 position on bar 450 carry out bending.

Inflatable occipital bone air cushion 416 be with 456,458,460 to form power transmission relations, and in operation, be positioned at assembly 452 below with head after, be generally positioned at occipital bone region.This occipital bone air cushion can be inflated and exit.In one embodiment, as shown in figure 23, this occipital bone air cushion 416 is connected in the snorkel 462 of face shield assembly 412 by pipe 414.Like this, the air pressure in occipital bone air cushion 416 is identical with the air pressure in face shield assembly 412.In the time that the pressure of face shield assembly 412 increases, this occipital bone air cushion 416 is just inflated, and this causes wearing tool tension force increases simultaneously, and prevents that face shield assembly 412 from departing from face, and leaks gas.So just, can be during different mask pressures, the movement of buffering suface shade assembly 412.

Occipital bone air cushion 416 is designed to have enough large area (A _bladder), make with occipital bone air cushion in air pressure (P in 416 _bladder) in conjunction with time, this air cushion acts on the active force worn on tool band 456,458,460 (power on bag 456,458,460 that acts on being caused by pressure in face shield assembly 412) by offsetting head.In general, the area of occipital bone air cushion 416 should be done quite greatly, to a power is provided, this power exceedes the power that face shield causes, this power is mask designs area (A _mask) and mask pressure (P _mask) product.Therefore:

A _bladder× P _bladder=∑ adds power on tape

In addition,

A _bladder×P _bladder＞A _mask×P _mask

In a kind of preferred form, this occipital bone air cushion 416 is about 11cm × 16cm, and its wall thickness is between about 1.5mm-2.5mm, and total venting thickness is 3-5mm.

In the above-described embodiments, the pressure in occipital bone air cushion 416 increases with mask pressure.But, in other embodiments of the invention, can utilize inflation and the venting of the parameter control occipital bone air cushion 416 except mask pressure.For example, the gas leakage of sensor in can detection faces shade assembly 412, method is, for example continuous detecting is connected in the flow in the source of the gas of face shield assembly 412 and low pass filter, to find the leakage rate of air-flow.In the time determining that gas leakage is very large, will make the pneumatic pad 416 of occipital bone inflate.On the contrary, when gas leakage is confirmed as when lower, can make the pneumatic pad venting of occipital bone.With the pressure of the pneumatic pad 416 of gas leakage detecting sensor control occipital bone, can make to wear tool 414 and remain on minimum amount of tension, this amount of tension also can keep facial sealing by face shield tool 412, and uncomfortable, the skin damage and the over-tension that contribute to alleviate end user are worn the intrinsic other problems of tool.

In addition, may wish to adopt more than one occipital bone air cushion 416 wearing on tool 414, if adopt the pneumatic pad 416 of more than one occipital bone, occipital bone air cushion 416 can be placed on some around wearing on some positions of tool 414.In addition, each the pneumatic pad in multiple occipital bone air cushions 416 can be inflated independently of one another and exit.This mode can more easily compensate the unsymmetry of patient's face because can part and wearing tool 414 in the place only needing in working tension.Therefore when the pressure in face shield assembly increases respectively or reduces, can make multiple pillows take offence and pad 416 inflations or venting, or can make these pneumatic pad gas and venting by sensing and control system, these sensings and control system are based on measuring air leakage work.

In another embodiment of the present invention, can adopt such as MIUSCLE of marmem (SMI) silk

(Mondo-Tronics, Inc, San rafael, CA, USA) makes sensitiveer tension part, and this B alloy wire shrinks in the time of galvanization.(systole response conventionally, producing when energising pond is because electric current causes the heating of B alloy wire by it.If) reach sensitive tension adjustment with such parts, need configuration controller separately to make this B alloy wire and mask pressure increase the contraction of synchronizeing.

" artificial muscle " that other suitable sensitive tension parts comprise servo motor and form with biomimetic material.

D. algorithm

For example just be inflated at the beginning predetermined tension force according to occipital bone air cushion 416 embodiment illustrated in fig. 16.In one embodiment, by mask seal the method that is fixed on patient's face comprise: the rear portion configuration by occipital bone air cushion against head and/or cervical region; One or more bands crossed or passed through this occipital bone air cushion, or being formed as a part for this air cushion, these reach out, and are connected in face shield; Use pressure P _bladderair pillow moral integrity pad, this pressure is mask pressure P _miskaffine function

P _bladder＝P ₀+A _maskP _mask

Wherein P ₀normal pressure, even as big as making face shield can reach sealing, A when the minimum predetermined working pressure _maskbackward contact area and occipital bone air cushion and less area in forward direction contact area between head rear portion above between occipital bone air cushion and band.

In these embodiments, the method that is used as the pressure inflatable occipital bone air cushion of mask pressure affine function comprises: measure mask pressure with pressure transducer, produce the signal that is proportional to mask pressure; Signal is added on gain and the adjustable amplifier of deviation; The output of amplifier is added on the controlled pressure source of voltage; With the gas inflated occipital bone air cushion in above-mentioned pressure source; Adjusting deviation makes face shield require pressure to reach sealing in minimum; Regulate gain, make face shield to be issued to sealing at peak demand pressure.

In these embodiments, if the signal V that pressure transducer comes _ptv _pt=K _ptp _mask, controllable pressure source produces pressure P _c=K _cv _c, face shield and facial contact area are A in the projected area of backward directions _mask, band is A with the pneumatic pad contact area of occipital bone in the projected area of forward direction _bladder, reaching the needed power of sealing at zero pressure is F ₀, the following output voltage of amplifier output:

V _out＝F ₀/A _bladder+A _mask/A _bladderK _c/K _ptV _in

In certain embodiments, comprise with the pressure inflatable occipital bone air cushion that pressure is mask pressure affine function: face shield is hose connection in the first cylinder that comprises first piston by first, this first cylinder is connected in the second piston in the second cylinder by connecting rod again, and the second cylinder is hose connection in occipital bone air cushion by second; The above-mentioned connecting rod of bias voltage, makes the inflation of occipital bone air cushion, is charged to and is enough to make face shield to be issued to sealing at minimum predetermined working pressure.

In certain embodiments, utilize spring and/or weight to form biasing force.

Device by mask seal on patient's face comprises: first group of telescopic band, and these are with rear portion from the beginning to lead to face shield, and this band is tensioned, and is tensioned under minimum predetermined working pressure and makes above-mentioned mask seal on face; Second group of non-retractable band, this band still rear portion from the beginning reaches forward face shield, and be placed on first group of band above; Be placed on the inflatable occipital bone air cushion of back of head, this air cushion between first and second groups of bands, above-mentioned occipital bone air cushion and pneumatic the communicating of air in face shield.

In operation, first group of telescopic band is independent of mask pressure provides fixing constant force, and the pneumatic pad working by second group of band provides the power with mask pressure linear change.These two power are added together, and form the power as mask pressure affine function.When the forward projection area of a less contact area in the contact area of occipital bone air cushion and back of head contact area and occipital bone air cushion and second group of band, when identical with rear orientation projection's area of face shield contact face area, approach very much best allocation.

In another embodiment, by mask seal the device that remains on patient's face comprise: one group of rigid strip, this band rear portion from the beginning reaches forward face shield; Be placed on the pneumatic pad of semi-rigid elasticity occipital bone between above-mentioned band and back of head, the pneumatic pad of this occipital bone is depressed in inner atmosphere, has the interior separation distance of non-zero between front walls and rear wall; Flexible pipe, is connected in face shield by pneumatic occipital bone pad.

Occipital bone air cushion can be made of elastomeric material for example silicone rubber, latex or polyurethane easily, fill this pneumatic pad with material springy, or by one or more contained springs or external springs, can regulate the elasticity of this pneumatic pad, this material springy is for example silicon rubber foam, latex foam, polyurethane foam and/or PVC foam.Can form comfortable inner spring with being full of occipital bone air cushion in the second elasticity that is sealed with air and/or fluid, this interior occipital bone air cushion is less than exoccipital bone air cushion.

Depress in inner atmosphere, preferably about 2-4cm of distance of separation before and after between occipital bone air cushion front and rear wall, be preferably 3cm, to allow cervical region to move in suitable scope, and increase within reason or reduction band active force, and in the time that mask pressure increases, allow has sizable pressure in the parts of back of head (hair, skin, fat, muscle) and face shield cushion and facial tissue.

Total rigidity of the pneumatic pad wall of occipital bone and any filling foam or spring preferably like this, make this rigidity can form a kind of power, this power is tensioned to when approximately medium at band, or during lower than the about 1.5cm of not tensioning length, is enough to make face shield to be issued to sealing in all predetermined pressures.Conventionally this power is about 200-600g, and this depends on characteristic and the cooperate degree of face shield.

In the time that the tension force of band increases under higher mask pressure, the tissue of face shield cushion and back of head is by compressed.This will cause the pneumatic pad of occipital bone to expand, because the pneumatic pad of occipital bone is preferably specially configured to rigidity, and take to lower than its relaxed length by tensioning and compressed, to be issued to the needed power F of sealing in low pressure arbitrarily ₀so in the time that the pneumatic pad of occipital bone expands, the elasticity of the pneumatic pad of this occipital bone will provide more and more less power.Should adopt its area is A _bladderthe pneumatic pad of occipital bone compensate this loss of elementary spring recoil strength, this area A _bladderbe greater than the area A of face shield _mask.

Do the used time when the pneumatic pad of occipital bone is under pressure, and forward action is at the rear portion of head with while acting on backward on tape, the flat lateral part of a part for this pad is contact zones, and can not contact this band at the sweep with both sides.The area only contacting with band, specifically this area projected area forward, will produce useful belt tension.In fact,, for adult's facial masks of typical sizes, it is suitable for example adopting the gas gallbladder of the about 17cm of side-to-side dimensions, the upper and lower about 11.5cm of size and thickness 3cm.The about 15cm of projected area side-to-side dimensions contacting with band, it is 150cm that the about 10cm of size, thereby the effect of gas gallbladder is up and down similar to area ²the effect of piston.Certainly these are only according to hobby and/or apply and the example of change.

Framework

A. adjustable framework

1. the first embodiment

Figure 36 illustrates embodiments of the invention, and this embodiment comprises framework 170, and this framework has the patient interface that form is cushion 172.These framework 170 use are many to be gone up with 180 heads that are bearing in patient, and this band adopts non-retractable material to make substantially, as mentioned above.Each is with 180 threaded portions that are included in its end, and this threaded portion is suitable for receiving nut 185, makes the tension force that patient can accommodation zone.Substantially be configured on framework 170 with the bending bar 175 that rigid material is done.

Configuration increases the governor motion 176 of framework 170 modulabilities.Specifically, governor motion 176 comprises adjustment screw 190, and this screw can rotate, and makes 195 translations of wedge part.This wedge part can move along an imagination axle 196, this imagination axle be configured in topmost headband 180 on framework 170 summits in line.Rotating adjustment screw 190 can make wedge part 195 against curved bel 175 inner surface translations.In the another kind of structure shown in Figure 36 A, configuration wedge part 195, makes it engage the outer surface of curved bel 175.In both cases, if wedge part 195 moves to the top of framework 170 upward, the top surface 197 of this wedge part 195 will be encountered inner surface or the outer surface of curved bel 175, and this will make framework around being arranged essentially parallel to imagination axis 196 or an axis bending with this dead in line.

This bending will make the both sides of side part pushing cushion 172 of framework 170, thrust can be acted on thus to the both sides of patient's nose.On framework 170 bottoms, form adjustability, make face shield can easily be applicable to dissimilar nose feature.This adjustability can certainly be along the top of framework or middle part form.This adjustability can allow patient under certain pressure, to regulate the contact force needing.This framework can deformation, rotation or bending, to adapt to the variation of pressure, the power that makes to be added on face is constant substantially.

2. the second embodiment

Figure 37 illustrates the embodiment that is similar to Figure 36 illustrated embodiment, but comprises other feature.For example, Figure 37 illustrates hole 200, and this hole is surrounded by for example iron hoop 210 of annular element.As shown in figure 38, this hole is suitable for receiving connector 215, and this connector is similar to ell, and this connector comprises the first iron hoop 220, and this iron hoop is suitable for magnetic and is connected in the iron hoop 210 of framework 170.This connector 215 comprises the second iron hoop 225, and this iron hoop is adapted to pass through the magnet ring 235 use magnetic that are formed on rotatable parts 230 and connects this rotary part 230.

Figure 38 illustrates the more details of soft cushion structure.Specifically, cushion 172 comprises for example foam of bottom parts 240 and for example silicone rubber of film 245, and the former is configured in the inside of framework 170, and the latter divides 240 supportings by bottom.

In Figure 37, amplify the distance between wedge part 195 top surfaces 197 and curved bel 175 inner surfacies, thereby can easily see all parts.

Figure 39 illustrates the details of adjusting screw(rod) 190, wedge part 195 and framework 170.Specifically, adjusting screw(rod) 190 comprises threaded portion 250 and is formed on the disc-shaped part 255 on adjusting screw(rod) 190 adjusting knob 260 opposed ends.Framework 170 comprises the transverse groove 260 that is suitable for receiving disc-shaped part 255.This framework 170 has the cannelure 265 that is suitable for receiving adjustment screw 190 threaded portions 250.This framework comprises other front groove 270, to receive the sub-body part 275 of wedge part 195.Framework 170 comprises the extension 271 with vertical part 272, and the feather edge 273 of this upstanding portion and framework 170 is spaced apart.This vertical part 272 comprises threaded supporting part 274.Wedge part 195 comprises groove 280, and this groove engages with the medial wall parts 285 that form cannelure 265.This wedge part 195 comprises partial screw threads part 290.This partial screw threads part 290 is suitable for engaging with threaded portion 250.

In order to assemble governor motion, threaded portion 250 and disc-shaped part 255 are inserted into respectively in cannelure 265 and transverse groove 260.Then the partial screw threads part 290 of wedge part 195 is transferred to the top of threaded portion 250, first main part 275 is positioned between vertical part 272 and inwall parts 285 inner ends near framework 170 bottoms 273.Then guiding groove 280, makes it slide along wall components 285.Therefore in the time of turning knob 260, this wedge part 195 will seesaw in the groove 295 of framework 170.Two extreme positions of wedge part 195 are shown in Figure 40 A and 40B.

Figure 41-53 illustrate other embodiment, and these embodiment can be along the both lateral sides pressurization of patient's face/nose.Because, so identical parts same reference numeral suitable with the embodiment shown in Figure 36-40B.In these embodiment, each embodiment can carry out more adjusting control, and more easily adaptive different nose shape patients' appearance changes.

3. the 3rd embodiment

In embodiment shown in Fig. 4, knob 190 is connected in a tooth bar in operation, is preferably connected in a pair of tooth bar 191, and in the time of turning knob 190, this tooth bar can in the opposite direction move.The far-end 193 of tooth bar 191 engages with the side part of framework, for example, when this framework is included in far-end 193 side direction and outwards moves, the cam face that thickness increases by wash rice, thus can make vertical axis bending, deformation and/or the rotation of framework around the imagination, strengthen thus the pressurization to patient's face/nose both sides.

4. the 4th embodiment

In the embodiment shown in Figure 42 A and 42B, film contributes to seal little gas leakage, and therefore accurately adjusting is not important.In addition, the embodiment shown in Figure 42 A and 42B can eliminate the perk from lower jaw substantially.Figure 42 A and 42B also comprise other point of adjustment, can make thus face shield and patient's cooperation further obtain fine tuning.For example each knob 190 is connected in the part 197 being configured on cushion 172 in operation.

5. the 5th embodiment

In Figure 43 A and 43B, framework 170 is semirigid, and cushion 172 is contained on compliant member 300.In the time increasing the tension force of band, parts 300 will contribute to seal the both sides of patient's nose to the elastic reaction of cushion.For example, compared with the rigidity of compliant member 300, framework 170 is springs of suitable rigidity.Therefore, the patient with Hubei Province fish shape face can depend on the rigidity of compliant member 300, and the patient with panda face can rely on the compliant member 300 keeping flat against framework 170, and this framework is flexible, but its rigidity is greater than the rigidity of compliant member 300.The not shown adjusting knob that comprises of this embodiment, but this embodiment can be adopted after this manner.

6. the 6th embodiment

In the embodiment shown in Figure 44 A-44C, rotate adjusting knob 190 and can make screw rod cammed surfaces 194 engage the protuberance 196 on cushion supporting member, can make thus cushion inwardly pressurize facing to patient's nose.

7. the 7th embodiment

Figure 45,46A and 46B illustrate an embodiment more of the present invention, and framework comprises flank part 305, and this flank part can be rotated with respect to framework 170.In principle, this embodiment is similar to the embodiment shown in Fig. 1, and in the embodiment in figure 1, configuration finger member 115, makes it rotate with respect to chassis 95.Figure 46 A is the exploded view of Figure 45 illustrated embodiment, and Figure 46 B is the assembly drawing of Figure 45 illustrated embodiment.This embodiment, as other embodiment, can make the side of cushion more easily fit and have the various patients of different nose shapes.This embodiment can also automatic attaching face configuration because with 180 each flank parts 305 that are connected in framework 170.The perk of face shield/cushion from buccal can be reduced, and more uniform cushion pressure can be on face, reached.This embodiment, as a lot of above-mentioned other embodiment, also can replace cushion, or use movable cushion.

8. the 8th embodiment

Figure 45 A and 45B illustrate an embodiment again, and this embodiment is similar to the embodiment shown in Figure 45, in this embodiment, can utilize snap action or escapement effect that flank part 305 is articulated and connected in many precalculated positions.Figure 45 B is partial exploded view, comprises the tongue 306 between two hinge portions that are configured in flank part 305.This framework 170 comprises many grooves 307 that are suitable for receiving this tongue 306, can be adjusted to thus many discrete positions.

Figure 47 and 48 illustrates, in the time increasing the tension force of band, flank part 305 be sealed in gradually the position on patient's nose N.

9. the 9th embodiment

Figure 49 and 50 illustrates another embodiment of governor motion, and this mechanism allows flank section componental movement, for example, rotate with respect to chassis or face shield assembly central frame.This governor motion comprises many holes 312, and these holes can receive the pin being configured on flank part 305 flanges 313.This hinge member 311 can be loose-leaf, pin or combination pin etc.

10. the tenth embodiment

Figure 51 is decomposition diagram, and the face shield assembly 510 of another embodiment of the present invention is shown.This face shield assembly 510 has two major parts, and 514, two parts of semirigid face shield chassis 512 and cushion/auxiliary frame 512 and 514 are separated, but can unclamp or fix, as mentioned above.In general, face shield chassis 512 is constructed and is configured to be connected in face shield and wears tool (not shown in Figure 51), and cushion/auxiliary frame 514 is constructed to and is suitable for carrying out comfortable sealing with patient's face.Face shield chassis 512 and cushion/auxiliary frame 514 have the parts that match, and cushion/auxiliary frame can be moved with respect to face shield chassis 512, or deformation, thereby provide a small amount of adjusting in the time making face shield assembly 510 mate end user facial.

In the following description, the term of some directivity, for example " top ", " bottom ", " left side " and " right side " will be adopted.Except as otherwise noted, adopting these directional terminology is for the coordinate system of each accompanying drawing.

Cushion/auxiliary frame 514 comprises cushion part 516 and auxiliary frame part 518.These two parts 516 are fixedly connected with 518.The size of cushion/auxiliary frame 514 is decided to be any other type of mask that can play oral area face shield, nose face shield, oral area-nose face shield or any and patient treatment agreement or reach an agreement on compatible with patient treatment.

Auxiliary frame part 518 is triangle or prismatic, has enough large internal volume, to receive the upper organ of face, cushion/auxiliary frame adds 514 and be designed to form sealing (such as nose, nose-oral area etc.) on these face positions.Auxiliary frame part 518 is openings in both sides.In the outside of auxiliary frame 518, configuration connector 520, this connector is connected in the pipe of source of the gas.In inner side, this auxiliary frame part 518 is opened, and leads in flange 522, and cushion part 516 is connected in this flange.Auxiliary frame part 518 use flexible or for example polypropylene manufacture of semiflexible material.

Cushion part 516 is generally soft adhesive parts, these parts can be for example silicone rubber membrane, be encapsulated in the foamed materials (polyurethane foam) in plastic foil or be filled with air and other gases can deformation sealing bag.This cushion part can be molded in (being melted to) auxiliary frame part 18, fix with bonding agent, or fixes by suitable connected mode.

Auxiliary frame part 518 also comprises structure and is configured to cushion/auxiliary frame 514 to be connected in the parts on face shield chassis 512.In top and the bottom of auxiliary frame part, on the auxiliary frame part surface of patient outside, be link 524, these parts are suitable for being inserted into the corresponding receiver hole 526 on face shield chassis 512, thereby cushion/auxiliary frame 514 is fixed on to face shield assembly 512.Link 524 is constructed to and is configured to can, to intrinsic deflection, to fix thereby form quick-snap between cushion/auxiliary frame 514 and face shield chassis 512 in the time inserting receiver hole 526.Although link 524 shown in Figure 51, the connector between cushion/auxiliary frame 514 and face shield chassis 512 can be the suitable connector of any other type.This auxiliary frame part 518 also comprises the protuberance 528 with some surfaces, and this protuberance 528 coordinates with regulating wheel 530 in the mode the following describes.

Face shield chassis 512 is generally the triangular plate that semi-rigid material is done, and this plate can be molded together with cushion/auxiliary frame 514.This face shield chassis 512 provides the gang socket 532 of face shield tool 534 respective end.On face shield chassis 512, configure two gang sockets 532, on each edge in the left and right edges on face shield chassis 512, configure a socket.But, if needed, can configure much gang socket 532, configure around face shield chassis 512, this depends on number and the position of face shield band or strap end portion.In Figure 51, gang socket 532 dough-making powder capouch are worn tool 534 and are expressed as releasably quick-snap connector.But this gang socket 532 can be the conventional link of any type.The top edge 540 on face shield chassis 512 generally comprises and is connected in face shield and wears the link to band or band portion before and after tool.Structure according to front and back to band or strap end portion, the link in top edge 540 can be gang socket 532 or other link.

Face shield chassis 512 comprises centre bore 536, and the structure in this hole and size are decided to be the outstanding core 518 that can receive cushion/auxiliary frame 514, makes connector 520 to be connected in suitable air feed pipe by face shield chassis 512 centre bores 536.Near the position of centre bore 536, is regulating wheel standing part 542 on 512 left and right sides, face shield chassis.The position of this regulating wheel 542 is generally corresponding to the position of protuberance 528 on cushion/auxiliary frame 514.Give prominence to respect to the surrounded surface on face shield chassis 512 each regulating wheel fixed position 542, and comprise for example screwed hole 544 of hole.

Clear operation and the mutual relation that regulating wheel 530, regulating wheel standing part 542 and protuberance 528 are shown in Figure 52 and 53, these figure are schematic cross section, be illustrated in the face shield chassis 512 of connection and the part for cushion/auxiliary frame 514 of bonding station, regulating wheel 530 is shown, this regulating wheel is contained in regulating wheel standing part 542, and engages the protuberance 528 on auxiliary frame 518.This regulating wheel 530 comprises threaded rod or rivet 546, one end of this threaded rod be fixed on that end user turns 548 in, twist screw rod to form hands, and its other end connects or is configured in hole 544.In Figure 52, taking turns 530 thinner or thinner part contacts with protuberance 528.Therefore, cushion/auxiliary frame 514 is substantially in unstrained state, and this state is not subject to the impact on face shield chassis.The undeformed state of cushion/auxiliary frame 514 can or can not form excellent sealing with end user's skin because exist gap or sealing load inadequate.

In order to regulate cushion/auxiliary frame 514 with respect to skin 550, end user can rotate regulating wheel 530, and what make regulating wheel 530 shifts to protuberance 528 compared with thickness portion, and contacts 528.One in the time that thicker part contacts protuberance 528, and auxiliary frame part 514 is just bending, thereby cushion 516 is moved to patient skin, or more close patient skin, thus can regulating sealing pressure and/or adjusting cooperation.Figure 53 illustrates regulating wheel 530, and this regulating wheel makes the position of cushion/auxiliary frame 514 to skin bending in it, thereby can eliminate the gap between skin 550 and cushion part 516 and/or improve cooperation/sealing therebetween.

Except above-mentioned governor motion, can make partly some part strength decreased on face shield chassis 512, to make the face shield chassis 512 can slight curvature, so that adaptive various face shape.The for example local part strength reduction that makes face shield chassis 512 W along the line, so just can make the face shield chassis 512 can bending.Face shield chassis 512 can be done to such an extent that have more rigidity than auxiliary frame, method is, or adopt different materials for example to adopt Merlon, or be configured to different geometries and for example add enhancing rib, or add constraints, for example use and wear the tension force of tool, or adopt the integrated processes of these methods.

Figure 51 illustrates embodiments of the invention, and in this embodiment, face shield chassis 512 and cushion/auxiliary frame 514 are parts separately, and cushion/auxiliary frame 514 is mainly caused by bending with respect to the motion on face shield chassis 512.But in other embodiments of the invention, comprise positioning element on face shield chassis and/or cushion/auxiliary frame, to make cushion/auxiliary frame with respect to face shield bobbin movement.In addition, that can not be formed as separating or the discerptible parts of face shield chassis and cushion/auxiliary frame, as described in other embodiment.

B. fin

1. the first embodiment

Figure 53 A-53G illustrates two closely-related embodiment of the present invention.Each embodiment constructs and is configured to contribute to improve the lateral seal power in nose both sides.These embodiment are useful especially in bridge of the nose part.But also can be used in the region of part under for example close nose of other regions and mouth.

Figure 53 A-53C illustrates an embodiment, and in this embodiment, framework has leg-of-mutton shape substantially, and in this example, this belfry becomes the face shield cushion that can support full-face, although this framework is suitable for the framework as nose cushion.This framework 600 can comprise for example any shape that plays interface interaction of circular, trapezoidal or applicable patient's presumptive area substantially of other shapes.

This framework 600 comprises a pair of side members 605, and each side members comprises connector interface 610, and this interface has at least one hole, preferably has many holes 615.Each hole 615 is constructed to the end that can receive headband, preferably can receive above-mentioned non-retractable end of wearing tool band substantially.This wears tool band can be connected in arbitrary hole in hole 615.In addition, these holes are formed on the sidewall 617 at connector interface 610.

As shown in Figure 53 B and 53C, comprise a pair of fin 620 towards the surface 616 of patient's face, this fin is configured to be positioned in use the positive outside of patient's nose both sides.As shown in Figure 53 B, fin 620 is configured in the nasal bridge region of patient's nose, but this fin 620 also can the larger or whole part extension along patient's nose dual-side.This fin 620 is constructed to and can be contained in the corresponding slot or groove forming on facial cushion (not shown) or in cushion outside.Each fin comprises one or more holes 625, and this hole contributes to form lock bolt between fin and cushion, and can weight reduction.

In use, fin 620 forms lateral-supporting to a certain degree, thereby contributes to keep the excellent sealing to patient both sides.For example, in the time increasing the tension force of band, common pad will trend towards side direction and outwards form waveform, increase thus the probability of infringement cushion sealing or comfortableness.Form fin 620 and also contribute to prevent that cushion from outwards rippling, thereby contribute to keep the sealing to nose both sides.

This belfry becomes and has flexibility, thereby can be around axis A rotation, bending or deformation.Like this, in the time of tensioning headband, this framework 600 can, around axis A motion, make fin inwardly move thus, is pressurizeed in patient's nose both sides.In addition or according to another kind of mode, in the time making face shield lateral curvature, rotation or deformation, as shown in the arrow of Figure 53 C, the top of framework 600 is divided 601 will be to the bending of patient's nasal bridge region, rotation or deformation, as shown in the arrow of Figure 53 B.In original position, 601 faces that are bent away from patient are divided at top.Therefore, regulate sidepiece band can strengthen the sealing of nasal bridge region, thereby do not want top band.

When face shield is during around main vertical axis A deformation, framework trends towards straightening along secondary horizontal axis B.This causes the top 601 of framework 600 more to shift near face, thereby cushion is pressed on the bridge of the nose.

This effect is mainly, when framework is during around an axis bending, will bear larger strain around the frame part of another axis bending.Therefore,, in order to reduce the strain in material as far as possible, it,, by intrinsic bending is straightened, changes to the position of lower strain energy.In the time that face is left in intrinsic bending, intrinsic bending is straightened and will make the more close face of part face shield.

Can find out, by changing incoherent plain bending position and direction, can make any requirement part of framework shift to or move apart satisfactory as curved frames in a known plane.

Alternatively or add, framework 600 comprises one or stop the line 630 of strength reduction more, the hinge lines of for example loose-leaf, as be formed on the hinge lines of the loose-leaf on framework 600 tops and/or bottom.The line 600 of this strength reduction will make framework 600 more easily around axis A activity.

2. the second embodiment

Figure 53 D and 53E are similar to the embodiment shown in Figure 53 A-53C very much.Main difference is that the connector interface 610 in Figure 53 D and 53D only includes a hole 615, this hole is for receiving the end of wearing tool band, this hole 615 comprises groove 617, and the size configurations of this groove becomes can make the relatively thin part of band slide into wherein, but does not allow the adjusting nut of bringing to pass through.In addition, as shown in Figure 53 E, different with the embodiment shown in Figure 53 A-C, this fin 620 does not comprise hole.

Figure 53 F illustrates that the framework 600 shown in Figure 53 D-E is positioned at the operating position being placed on patient's head model.Cushion C and ell have been contained on framework 600.Figure 53 G is the sectional view of framework.

C. there is the framework of sealing gasket

Figure 53 H illustrates another embodiment of the present invention, and in this embodiment, framework 640 is equipped with sealing gasket 645.Sealing pad extends along the bottom 650 of framework 640, and is configured in fastener 655 and at least a portion is worn below tool band 656, and this part is worn tool band and be configured in each sidepiece 660 of framework 640.Therefore sealing gasket 645 provides another kind of comfortableness, can prevent fastener 655 and/or with may the rubbing of Hubei Province under 656 couples of patients, sealing pad can be used gel and/or foamed materials manufacture.

D. there is the framework of peg

Figure 53 I illustrates the second frame parts 662 of the first frame parts 661 and for example cushion 663 of the facial interface pieces of supporting.The first frame parts 661 comprises main opening 664 and many first holes 665.The second frame parts 662 comprises many second holes 666 of aliging with the hole 665 of the first frame parts 661.The second frame parts 662 comprises protuberance 667, and this protuberance is constructed to the main perforate 665 that can insert the first frame parts 661.

Many pegs 668 are configured between the first and second frame parts 661 and 662.Each peg 668 comprises first end 669 and the second end 670.First end is inserted in the first hole 665, and the second end 670 is contained in the second hole 666.Each peg 668 has distance piece or retainer 671.Each peg 668 has length " L ", and this length is chosen as can be with respect to its degree of depth of the internal regulation of cushion 663.For example, the peg 668 illustrating has all lengths, makes the second end 670 can penetrate the second hole 666, through in cushion 663 to the specific degree of depth of patient's facial appearance.As shown in the figure, this peg is fixed by interference fit, can make framework 661,662 and/or cushion 643 in position, or peg 668 can comprise other structure, so that fixing cushion or frame parts for example comprise barb or side groove.

E. inflatable cushion

Figure 53 J-53P illustrates embodiments of the invention, and its middle frame 170 supports the cushion 172 of for example doing with silicone rubber and/or foamed materials.Framework 170 comprises one or more tool link positions 171 of wearing, and these positions are around the periphery configuration of framework 170.Cushion 172 comprises inflatable gas gallbladder 173, and this gas gallbladder is configured in the nasal bridge region of patient's nose.Gas gallbladder shown in figure is the single part being embedded in cushion 172, but this gas gallbladder can comprise the some separate parts that are positioned at requirement position of the discrete parts that is configured in air cushion 172.For example, this gas gallbladder can comprise two gas gallbladders, and these two gas gallbladders are configured in each side of cushion, but does not comprise the summit of cushion.This or each gas gallbladder 173 communicates with such as air source of substance source or gel source etc., thereby regulates the volume of gas gallbladder 173.Configure this or each gas gallbladder, can reduce or reduce the distance between relevant cushion/frame part and patient's face.For example, when Figure 53 L-53P is illustrated in framework 170 and is pressed in both sides, the distance of nasal bridge region diminishes gradually.Figure 53 L-53P illustrates, the variation of cushion both sides shape is asymmetric, although cushion and/or gas gallbladder 173 preferably change shape in symmetrical mode, this depends on that the appearance of patient's nose is symmetrical asymmetric.

Also can form like this cushion 172, make it in the time that pressure increases, reduce the ripple of both sides cushion as far as possible.For example, the lateral wall of cushion (away from the wall of patient's nose one side) can be made up of the relatively thick wall components of specification, and the impact that makes not relatively to be stressed and increase can reduce thus outer wall and increase the probability that ripple occurs with pressure.On the contrary, cushion inwall (near the wall of patient's nose) can be made up of the wall components of specification relative thin, and this wall components can make these walls paste patient's nose bending, can strengthen thus sealing.

Cushion

According to the usage of this explanation, term " at rear portion " refers to that with " rear portion " cushion assembly is suitable for contacting that side of patient's face, and term " in front portion " refers to that with " front portion " cushion assembly contacts that side of mask shell or main body.According to usage of the present invention, term " face shield " refers to the face shield of nose face shield and whole face.

Figure 54 A-54C is respectively decomposing rearview, side view and the flat sheet of the bottom view of ACLAIM nose face shield that another known mask is manufactured by Fisher & Paykel (F & P).This ACLAIM nose face shield comprises rigid frame or shell 50 and cushion assembly, and this assembly comprises the thin silicon rubber membrane 10 and the foam gasket ring 30 that form sealing.This shell 50 comprises the groove 51 being formed by inwall 52.In use, these foam gasket ring 30 local configuration are in groove 51, and rearward extension (near patient's face).Film 10 is fixed on the edge of shell 50 by tongue and groove mechanisms 60 (Figure 54 D).Foam gasket ring 30 plays supporting member effect.

According to this, cephalocaudal usage is described, term " ACLAIM cushion " refers to the cushion assembly shown in Figure 54 A-54D.

The for example problem of ACLAIM cushion of the cushion of some prior aries is that these cushions, under High Pressure, are easily collapsed, and cause easily contact frame edge of face.This is uncomfortable to patient, and causes impression or pain on its face.

With reference to figure 55A-55D, the cushion assembly 100 of first embodiment of the invention comprises silicone rubber membrane 110 and lower floor's cushion (U/C) 120, and this bottom cushion is similar to

lower floor's cushion of cushion.This film 110 and lower floor's cushion 120 are supported by bottom cushion flange 140.This film 110 and lower floor's flange 120 can be formed as single part with bottom cushion flange 140.This film 110, lower floor's cushion 120 and bottom cushion flange 140 can be made of silicone rubber, and can be formed as parts separately, or are formed as single parts.Although not shown in the drawings, but cushion flange, film and lower floor's cushion are generally triangle, with ridge area, buccal region of face or labial region,superior (in the situation of nose face shield), or match with the employment face contour of wearing that chin district (situation of full-face face shield) forms.As shown in Figure 55, film 110 its shapes are generally identical with lower floor cushion 120, and surround lower floor's cushion 120.

Cushion assembly 100 is included in the compliant member 130 between film 110 and lower floor's cushion 120.In a preferred embodiment, this compliant member is foam insert.With reference to Figure 55 D, compliant member 130 is configured between film and lower floor's cushion 120.This compliant member 130 is supported by lower floor's cushion 120, and bears the moderate compression that cushion assembly 100 starts.At the compliant member of first embodiment of the invention shown in Figure 56 A-56F.

This compliant member 130 is inserts, with for example polyurethane foam making of soft compressible elastomeric material.This compliant member 130 also can be made of soft silicone rubber, and its hardness is for example Durometer A hardness 20 or lower.This compliant member 130 can also be thermoplasticity compliant member.

It acts on compliant member 130 as spring, has initial low spring constant.Except compliant member 130, lower floor's cushion 120 shows the relatively characteristic of hard spring constant.In the first embodiment, the respective action of each layer is: (i) film 110 forms sealing between its outer surface and patient's face; (ii) compliant member 130, as being obedient to layer, can prevent that film 110 from collapsing on lower floor's cushion 120 too early thus; (iii) the cushion flange of cushion assembly 100 is as supporting course, prevent that film 110 from crossing componental movement with respect to face, can prevent thus main body or the housing of facial contact framework, face shield, or contrary, prevent that face from moving with respect to film 110, breakseal.

Compliant member 130 is configured as along the cavity between film 110 and lower floor's cushion 120 of cushion assembly 100.Compliant member 130, for the gap of film inner surface 115, is that film 110 still can be rippled to outside, is sealed on patient's face.

Figure 57 A-57C illustrates the mechanical property of cushion assembly 100 (Figure 57 A), and with

the mechanical property of cushion (Figure 57 B) and ACLAIM cushion (Figure 57 C) compares.Y axle represents relative cushion height h/ho, and in the time that cushion assembly 100 is positioned at its original height ho, this relative cushion height is 1.If cushion assembly 100 is compressed to the half of its original height, cushion height is 0.5 relatively.X axle represents to act on the pressure F on cushion assembly 100.This power F acts on to be used in making a concerted effort on cushion assembly 100 between mask shell and patient's face.

With reference to Figure 58 and 59A-59F.The cushion assembly 200 of second embodiment of the invention comprises film 210, flexible lower floor cushion, compliant member 230 and bottom cushion flange 240.This film 210 and lower floor's cushion 220 can form single part with bottom cushion flange 240.Bottom cushion flange 240 is fixed on mask frame or shell 250 in its rear rim.In a preferred embodiment, this compliant member 230 is foamed materials inserts.This compliant member 230 also can be made of silicone rubber.

Figure 60 A-60C illustrate respectively second embodiment of the invention cushion assembly 200,

the mechanical property of cushion and ACLAIM cushion.Figure 60 D is illustrated in the comparison of three cushions in a coordinate system.Y axle represents relative cushion height h/ho, and the pressure F of x axle role of delegate on cushion.This pressure representative is the percent that acts on maximum pressure on cushion assembly.

With reference to figure 60A, in the main beginning region corresponding to film 210, apply approximately 20% pressure of maximum, force, cushion height is reduced to approximately 95%.At the second area corresponding to cushion assembly 200 compliant members 230, while applying the pressure of approximately 60% maximum, force, compression is increased to 80% from 95%.In the 3rd region of corresponding lower floor cushion 220, power is increased to 100% of maximum pressure, can only compress a little cushion assembly 200.

Figure 60 B illustrates

the mechanical property of cushion.Can obtain approximately 75% compression in the compression stress that applies approximately 50% maximum pressure corresponding to the region of film, further increase compression stress and only cause cushion relative altitude to decline a little, the compression of this corresponding lower floor cushion.

Figure 60 C illustrates the mechanical property of ACLAIM cushion assembly, uses less power just can quite easily reach approximately 90% initial compression.The further increase of pressure subsequently causes, and applies approximately 30% maximum pressure and will cause the very large compression of foam insert.Applied pressure is during higher than approximately 30% maximum pressure, and ACLAIM cushion assembly is only produced to very little compression or even without any compression, because foam insert is compressed in mask shell completely.

Figure 60 B is illustrated in the comparison of three curves above in a coordinate system.

Figure 61 is schematic diagram, by respectively compliant member 130,230 and lower floor cushion 120,220 being likened into the method for spring, the effect of the first and second embodiment cushion assemblies 100,200 is shown.The spring constant of compliant member parts 130,230 is less than the spring constant of lower floor's cushion 120 and 220.As shown in Figure 61, compliant member 130,230 plays slinky spring, at the pressure that starts to absorb cushion assembly.This compliant member 130,230 has strengthened the flexibility sensation of cushion assembly 100,200, and has increased the stickiness on 100,200 pairs of patient surfaces of cushion assembly, has improved thus sealing, reduces or has eliminated gas leakage.

In the time acting on pressure on cushion assembly 100 and 200 and increase, will start to compress compared with lower floor's cushion of rigidity 120,220.Lower floor's cushion 120,220 reduces or has eliminated the probability of patient's facial contact mask shell.

With reference to Figure 62, the cushion assembly 300 of third embodiment of the invention comprises the film 310 stretching out from bottom cushion flange 340.Mask shell 350 is fixed in the rear end of bottom cushion flange 340.Between film 310 and bottom cushion flange 340, configure compliant member 330.The compliant member 330 of this embodiment is general higher or dark than the first and second embodiment compliant members.A kind of material manufacture of compliant member 330 in this embodiment.Cushion flange 340 does not comprise lower floor's cushion.In this embodiment, film 310 reaches main sealing, and is supported by compliant member 330, this compliant member by pressure distribution on diverse location, thereby obtain more comfortable mask system.

At other diagrams of compliant member 330 shown in Figure 63 A-63E.In this embodiment, compliant member 330 comprises multiple parts 331,332,334,335 of different qualities (stress and deformation characteristic).As shown in Figure 63 B, this illustrates the rear side of compliant member 330, and part 333 and 334 can be placed on the nasal bridge region of face shield.This part 333 and 334 has same size and shape, but has different spring constant (being rigidity), to adapt to the difference of indivedual patient's face size and shapes.It should be noted that part 331,332,333 and 334 has different sizes, shape and spring constant, to adapt to the difference of indivedual patient's face size and shapes.Should also be noted that the part that can adopt any number.

Compliant member 330 is supported by rigidity retainer 335.This retainer 335, in the time of assembling cushion assembly 300 and face shield, keeps compliant member 330.This compliant member 330 and retainer 355 can combine, as sub-component.This retainer 355 also comprises the extension with ell stationary fixture 360.The required ell 370 of these ell stationary fixture 360 fixed gas source air feed.Figure 64 A-64E illustrates other accompanying drawings of this retainer.

With reference to Figure 65, the cushion assembly 400 of fourth embodiment of the invention comprises two-layer or three layers of parts.Ground floor is made up of cushion flange 440.The front side of cushion flange 440 is applicable to being connected in the shell of face shield.The second layer is made up of the compliant member 430 that is connected in cushion flange 440.Compliant member 430 is determined the shape of cushion, and forms the facial parts of contact.This compliant member 430 has the 3rd layer that is made up of top layer 460.

Ground floor (cushion flange 440) is polyurethane rubber (non-foam) rigid layer.The second layer (compliant member 430) is made of urethane foam or soft silicone rubber.The 3rd layer (top layer 460) is made up of silicone rubber top layer.Top layer 460 its thickness are preferably 0.2-0.6mm, this thickness or uniform, or according to load, or the degree of deformation as requested changes.

With reference to Figure 66, the cushion assembly 500 of fifth embodiment of the invention comprises two-layer or three layers of parts.Ground floor is made up of cushion flange 540.The front side of this cushion flange is applicable to connecting the shell of face shield.This cushion flange 540 comprises supporting part 545, and this supporting part stretches to rear side from front side.This supporting part is flexible, and its effect is similar to lower floor's cushion.The second layer is made up of compliant member 530, and it is cushion flange 540 that this compliant member is connected in, and around supporting part 545.Compliant member 530 is determined cushion shape, and forms the facial parts of contact.This compliant member 530 has the 3rd layer that is made up of top layer 560.

Ground floor (cushion flange 540) is the polyurethane rubber (non-foam) of rigidity.Second is made up of urethane foam or soft silicone rubber.The 3rd layer (top layer 560) is made up of silicone rubber top layer, and this top layer has above-mentioned uniform thickness or variable thickness.

In use, when this compliant member 530 is worn with human face and exerted pressure in contact, just start compression.In the time that pressure increases, this compliant member 530 is just further compressed, until be crushed on completely on supporting part 545.Further exert pressure and will cause the compression of supporting part 545.Therefore compliant member 530 and supporting part play two spring actions, and its mode is similar to the mode shown in Figure 61.

With reference to Figure 67, the cushion assembly 600 of sixth embodiment of the invention comprises ground floor and the second layer.Ground floor is made up of cushion flange 640, and the front side of cushion flange 640 is incorporated into mask shell.The second layer is made up of the compliant member 630 that is connected in cushion flange 640.This compliant member 430 is determined the shape of cushion, and forms the facial parts of contact.

Ground floor (cushion flange 640) is polyurethane rubber (non-foam) layer of rigidity.The second layer (compliant member 630) is made up of foam, and comprises rigidity relatively low Part I 631 and the relatively high Part II 632 of rigidity.Adopt different densities foamed materials to form compliant member, can obtain different rigidity, as used as shown in the point of relative spacing in Part I and Part II 631 and 632.Compliant member 630 is the single parts with different densities, or has some parts of different densities.Although compliant member 630 is expressed as and has two kinds of different rigidity (density) in Figure 67, will be appreciated that, compliant member 630 can have two or more rigidity (density).As shown in Figure 67, Part II 632 comprises the region 632a that extends through cushion flange 640, can prevent from thus wearing being pressed on cushion flange 640 with human face.

In use, when the Part I 631 of compliant member 630 is worn with human face and Jia upward pressure in contact, just start compression.In the time that pressure increases, Part I 631 compresses completely, and Part II 632 starts compression simultaneously.Because Part II 632 is harder than Part I 631, so the reduction of the relative altitude of the cushion assembly 600 causing by exerting pressure in second area 632 is less than first area 631.

Although not shown in Figure 67, should see, cushion assembly 600 can have the 3rd layer of for example top layer.

Figure 68 and 69 illustrates another embodiment of the present invention.Airfoam cushion 700 is fixed on framework 705.This framework comprises the hole 710 through cramp bar 715.This hole 710 and cramp bar 715 each other screw thread screw up, and the position of bar 715 head part 720 can be moved, as shown in double-head arrow.As shown in Figure 69, framework 705 has adjusting knob 725, thereby bar 715 is moved.Although illustrate on figure that framework 705 only includes an adjusting rod 715, can configure multiple such adjusting rods.In given pressure limit, the position of adjusting rod 715 can make the configuration of cushion change.

Figure 70-79th, cross-sectional view, illustrates other airfoam cushion embodiment of the present invention.

In Figure 70 and 71, the inside of airfoam cushion 729 comprises spring members 730.Can be according to cushion the position with respect to patient's face, change the amount of spring members 730 cushion material above.For example, at problematic or responsive sealing area, can be out of shape cushion, spring members 730 can be deeper embedded in cushion, can utilize thus cushion itself to reach and the sealing that has problem or sensitizing range, and the effect of spring members, if any, neither be too large, an advantage is that spring members 730 is to embed completely, cannot see, so feel to seem simple, this may affect the compliance of patient treatment.

Figure 72 comprises the Flexible film 734 of manufacturing with the cushion 732 of foamed materials manufacture and the most handy silicone rubber, and this film is configured on the inner surface of cushion 732.Easily laminating patient face of this Flexible film 734.Figure 73 is a kind of device on supporting member 732 lateral surface with film 736.

Figure 74 is a kind of device, and in this device, cushion 732 has the groove 738 being communicated with chamber 740, and this chamber is configured in the inside of cushion 732.This groove 738 is communicated with compressed air source or other substance source example gel sources, makes to change the stiffness characteristics of cushion.

Figure 75 A, 75B and 79 form the varying cross-section of at least two spring rates while being illustrated in cushion compression.In Figure 77 and 78, cushion 732 comprises at least three kinds of spring rates between compression period, and in Figure 77, cushion 732 comprises three layers of L1, L2 and L3, and each layer has different spring rates.Figure 78 has the first spring rate in head part 747 is pressed into groove 748 time, has the second spring rate in core 749 is pressed into the second groove 75 time, and has the 3rd spring rate at 753 o'clock entering bottom point.

Figure 76 illustrates the cushion 732 with indenture 756, and this indenture contributes to by for example sealing between air-breathing maintenance cushion and patient surface.

Advantage as the foam insert of compliant member is, foam more easily compresses than silicone rubber, and therefore, the cushion assembly that comprises foam insert of the present invention more uniform distribution is worn the active force of tool.

Advantage as the silicone rubber of compliant member is, silicone rubber easy cleaning, and with patient's bio-compatible more.It should be noted that, all parts in the above-described embodiments, film, compliant member and cushion flange play a kind of mechanical spring.Can combine above-described embodiment, the for example compliant member of the first and second embodiment can have the different region of multiple rigidity (density), or the various piece of the second embodiment compliant member can have the different region of multiple rigidity (density).Adopt the multiple combination method of above-mentioned film, compliant member and cushion flange can meet the requirements of level of comfort.

Compliant member can be made of viscoelastic foam density constant or that have multiple density, to reach requirement effect.That this compliant member also can communicate with micropore density constant or that have multiple density or closed foamed materials manufacture.This compliant member can be used, also can be without Surface mulch.

Can adopt the face shield tool of four bands according to the face shield assembly that comprises cushion assembly of one embodiment of the invention, this face shield tool is similar to the ULTRAMIRAGE being manufactured by Res Med Limited ^tMthe face shield tool of mask system.

The face shield assembly that comprises cushion assembly of the embodiment of the present invention can adopt the fastener of wearing described in U.S. Patent No. 6374826, and the content of this patent is included in this article as a reference.

The advantage of mask system cushion assembly of the present invention is to have increased end user's comfortableness.Just can reach the people of sealing for the very large belt tension of needs, this may be due to due to active force is evenly distributed.Compliant member also contributes to keep the shape of film, and the sealing of remaining valid during end user's unconscious activity in evening.

Other advantage of cushion assembly of the present invention comprises easy manufacture, low cost of manufacture.Cushion assembly of the present invention is compared not too complicated with for example ACLAIM cushion of prior art cushion, this ACLAIM is the cushion of three parts, need to before being fixed on face shield, assemble.

An advantage more of the present invention is that compliant member only causes less film distortion, so just makes doctor/clinical staff that face shield is installed in the short period of time, and reaches sealing more reliably.

An advantage more of the present invention is below film, to configure compliant member and can reach more stable sealing.This compliant member is owing to having reduced the motion of face shield, so the seepage velocity variations between face and cushion is also less.Like this, just, improved the treatment that press of dual device provides.

For correct power is provided, compliant member should have suitable power placement property, and this requirement is, parts should be enough soft, so as just bending at the beginning, coupling face organ, but should be because of the pressurization of cushion flange rigid element, cause completely compressedly, make that end user's is uncomfortable.

In more above-mentioned embodiment, cushion is configured on framework with binding agent, and in another embodiment shown in Figure 80, this cushion is fixed on framework with machanical fastener.In the example of Figure 80, face shield assembly 900 comprises main part 902 and is fixed on the cushion 904 in this main part 902, and this cushion 904 comprises the neoprene latex cushion 906 covering with for example continuous silicone rubber membrane 908.Flexible portion 910 is because above-mentioned reason configures along the periphery of main part 902.Main part 902 and film 908 are made up of single part in this example.This film 908 comprises the periphery shoulder 914 on interior all shoulders 912 and connecting flexible framework 910 surfaces 916, and this periphery shoulder 914 encases the edge of flexible frame 910.Or periphery shoulder may be described as to comprise receives the outer peripheral groove of flexible frame 910.Equally, interior all shoulders comprise the groove of receiving soft framework 910 inner periphery.In other words, parts 908 can quick-snap on the edge of framework 910.

The edge card of cushion is combined on framework and just no longer needs to use neoprene latex cushion is bonded on framework, although adopt this bonding between neoprene latex cushion and silicone rubber membrane.This configuration forms the fabulous globality of assembly, forms more reliable combination between all parts, and has eliminated the relevant issues that need chemical compatibility between bonding neoprene latex cushion and nylon framework.

This face shield assembly is enough solid, can bear the power that extreme condition applies, and therefore more reliable, patient is safer.Film 908 provides a kind of sealing air path that leaks gas little.

Figure 81 illustrates the relaxation curve that is used in foamed materials in compliant member of the present invention.

Tabular below goes out to be suitable for the exemplary characteristic of the foamed materials of all embodiment compliant members of the present invention:

Characteristic	Numerical value
		Density	0.1752(g/cm 2)
At 25% CLD	1.054(N/cm 2)
		At 65% CLD	3.375(N/cm 2)
Sag coefficient	3.20
		IHF	4.36
Return rate %	57

Definition below obtains from existing open source literature, but illustrates that its measurement unit of table of characteristic is not above-mentioned definition measurement unit used above.

Density is the weight of unit volume foam, is expressed as pound/foot below ³, but upper table density meter is shown g/cm (pcF) ³.The general density range of flexible polyethers urethane foam material is between 1-4pcf.This density is not the tolerance of hardness, and latex rubber foam is different.For meeting given load bearing requirement, the foamed materials of higher density generally has preferable quality and performance.

Pressure load deformation (CLD) (compression load defletion) is also a kind of tolerance of support load, is generally expressed as the pound/inch under certain percentage deformation condition ²(psi) in this test, compress whole sample, the numerical value of mensuration and depth of foam are irrelevant, as long as not overlength degree and width of thickness.Adopt CLD to represent the specification of certain special foamed materials hardness and some half flexible foam hardness.These numerical value also can be used for being determined under various deterioration with moistures or heat ageing condition, the variation of load ability to bear.

The impression deformation (ILD) (indenation load deflection) of load is a kind of tolerance of load ability to bear, is expressed as pound load/50 inch under given foam percentage deformation condition ².In order to obtain this numerical value, the plectane of 50 square inches (a) is pushed to the top surface of foamed materials, under given deformed state, stop, and read load or scale.For example, 30 25%ILD means, needs the load of 30 pounds the foam for panel of 4 inchs could be compressed to 3 inchs, and load is larger, and foamed materials is just harder.In this test, the size of foam sample is greater than the size of plectane, for dull and stereotyped foamed materials, is generally 15 × 15 inches.

In some standards, adopt other plate structure and dimension definitions ILD.ILD is sometimes referred to as RMA (meeting of rubber technology), measures from the same of latex foam material.The recommendation rules that characterize flexible foam specification are: USU (Urethane Slab Uncored); USC (UrethaneSlab Cored); UMU (Urethane Molded Uncored); UMC (Urethane MoldedCored).At this yard numeric representation 25%ILD below, for example USU-30 refer to there is 30 25%ILD be not in the mood for plate foam material, in the time that measured value is subject to foamed materials original thickness and affects, the original thickness of foamed materials must be shown.(seeing BASF Wyandotte TechnicalAdvisory, " Effect of Foam Thickness on ILD " .)

Sag coefficient is 65%ILD and the ratio of 25%ILD, represents cushion quality.High numeric representation touches the resistance at the end.There is foamed materials " touching the end " conventionally of low sag coefficient, poor performance.Other terms of this coefficient are SAG coefficient and SAG modulus.

Initial hardness coefficient (IFH) is 25%ILD and the ratio of 5%ILD.This parameter identification surface feel.Foamed materials flexible or pressure release surface has higher numerical value, and the stiffening foamed materials in surface has lower value.Another term of initial hardness coefficient is comfortable coefficient.

In the time measuring ILD, conventionally read in 25% displacement, 65% deformation and removing the numerical value of getting back to again 25% deformation after load.With starting 25% deformation values, to get back to this 25% deformation values when removing load be recovery rate, is expressed as %.For being used as liner, the recovery rate of having relatively high expectations, requires the low recovery rate in the end for absorbing vibration.The foamed materials of low recovery rate is sometimes referred to as " nonelastic ".

Indentation residual gauge load (ERGL) is the metering of another kind of load ability to bear, is expressed as the inch value of a fixed load.Adopt same 50 square inches of plectanes of measuring ILD, but this plate loads certain load.Normal loading is 25 pounds, 50 pounds or 75 pounds.IRGL value represents with inch.Must know the original thickness of foamed materials, so that the value obtaining is meaningful.This tolerance is through being usually used in illustrating automobile foamed materials specification.Between ILD and IRGL measured value, there is no ready-made dependency relation.

Guide factor is 25%ILD and the ratio of density, and this term is for determining the relative hardness of different densities foamed materials.Density is more approaching, better comparison.In the time that density is different, the foamed materials with the highest Guide factor has cost advantage.But performance differs and reserves.Another term of Gridefactor is normalized ILD.

Impression modulus (IM) is within the scope of the ILD of 20%ILD and 40%, produces the required load of 1% impression.The slope of this straight line depends on the resistant to bending ability of microcellular foam wall.

Resilience is the one tolerance of foamed materials elasticity or elastic force.In this test, steel ball is dropped on foamed materials, and bounce-back is expressed as to percentage resilience, the same with response rate, the value of requirement depends on application.May make people misread for very soft foamed materials resilience, because under the effect of ball, foamed materials will touch the end.Like this, even if foamed materials is " flexibly " or elastic, but also obtain very low resilience value.Ball bounce-back is another term of this characteristic.

Tensile strength is that foamed materials is being stretched and the one tolerance of the required amount of stress that ruptures, and is expressed as pound/inch ²(psi) tensile strength can be used as quality inspection control, and a kind of common test is after heat ageing, measures the variation of tensile strength.

Extensibility is generally measured in measuring tensile strength.Extensibility is the tolerance of the elongation that can stretch before foamed materials fracture, is expressed as the percent of original length.

Tear strength is a kind of after foamed materials has started to split or disconnected, continues to tear the one of the required power of this foamed materials and measures, and is expressed as pound/linear inch (pli, or more common be pi).At needs, material is sewed, with nail peg or the application of " being bent to form annular (hog-ringed) " in, for determining that this characteristic is very important in the suitability of measuring foamed materials.

Compressive deformation (compression set) is under the controlled time and temperature conditions, after keeping foam compresses, and the tolerance of foamed materials deformation.Standard conditions are under 158 °F of conditions 22 hours.In this test, foam compresses, to given thickness, is expressed as to the percent of its original thickness.The most common percent that is expressed as initial compression of compressive deformation.

Fatigue is a kind of one tolerance of load ability to bear loss under service-simulated conditions, is generally expressed as percentage rate load loss.Two prevailing testing fatigues are static fatigue test and pressure roller shear fatigue test (roller shear fatinue).

In static fatigue test, foamed materials is at room temperature compressed to 25% of its original thickness, compress 17 hours, will calculate ILD loss, be expressed as the percent of initial value.

In the test of pressure roller shear fatigue, make pressure roller on foamed materials the rollback longer than foamed materials width moving.This roller is contained in transversely movable position, to apply shear force.In the time of the constant deformation setting value of application or constant pressure roller weight, method of testing difference, according to the explanation of method of testing, calculates the loss amount of ILD or IRGL.

Air mass flow is the one tolerance of foamed materials porosity or unlimited degree, is expressed as cubic foot of air/min (cfm).According to the explanation of ASTM method, utilize vacuum that air was taken out to foamed materials, or according to the explanation of BASF Wyandotte Technical Advisories report, use device, " BWC portable air flow measurement device " and " BWC portable air flow measurement improved device ", makes air blow over foamed materials.

Also have many other foamed materials characteristic and method of testings.Wherein manyly find out, for the special aspects of considering.In standard method D-1564 and D-2406 in the special foamed materials specification part of ASTM, can find other term definition and the explanation of method of testing.

Although the present invention, according to now the most applicable preferred embodiment explanation the present invention, it should be understood that and the invention is not restricted to disclosed embodiment, on the contrary, present invention resides in various modification and equivalent device in spirit and scope of the invention.

Claims (18)

1. for the treatment of a face shield cushion assembly for the irregular breathing of sleep, this cushion assembly comprises ground floor, and this ground floor is connected in the second layer, wherein:

Ground floor is made up of cushion flange, and the front side of cushion flange is suitable for being engaged in mask shell; And

The second layer is made up of compliant member, this compliant member is determined the shape of cushion and is formed the facial structure of joint, wherein this second layer is made up of foamed materials, and in use, in the time engaging, this second layer is at face shield and wear with forming sealing between human face, and compressed when afterburning to cushion assembly.

2. cushion assembly as claimed in claim 1, wherein the second layer comprises top layer.

3. cushion assembly as claimed in claim 2, its mesexine is formed by silicone rubber.

4. cushion assembly as claimed in claim 1, wherein the second layer is made up of urethane foam.

5. cushion assembly as claimed in claim 1, wherein foamed materials comprises the foamed materials of multiple density.

6. cushion assembly as claimed in claim 1, wherein foamed materials foam that communicated by micropore or closure forms.

7. cushion assembly as claimed in claim 1, wherein ground floor comprises the surface that is suitable for engaging mask shell.

8. cushion assembly as claimed in claim 7, wherein ground floor comprises the groove that is suitable for the one or more surfaces that engage mask shell.

9. cushion assembly as claimed in claim 8, one or more surfaces of wherein said shell comprise one or more edges.

10. cushion assembly as claimed in claim 1, wherein foam is the flexible polyethers urethane foam of density in the scope of 1-4pcf.

11. cushion assemblies as claimed in claim 1, wherein ground floor is made up of the polyurethane rubber material of foamless rigidity.

12. cushion assemblies as claimed in claim 1, wherein ground floor formation cushion flange and the second layer comprise Part I and the relatively high Part II of rigidity that rigidity is relatively low, Part II comprises the region of extend through cushion flange.

13. cushion assemblies as claimed in claim 1, wherein the second layer does not comprise top layer.

14. cushion assemblies as claimed in claim 1, wherein ground floor is the cushion flange that is suitable for engaging mask shell, and the second layer is compliant member.

15. cushion assemblies as claimed in claim 1, wherein ground floor comprises supporting part, this supporting part stretches to rear side from front side.

16. cushion assemblies as claimed in claim 1, wherein ground floor is fixed to shell by syndeton.

17. cushion assemblies as claimed in claim 1, wherein this cushion assembly is connected to shell with binding agent.

18. 1 kinds of face shield assemblies, comprising:

Framework; And

Cushion assembly as described in any one in claim 1-17.

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