CN1735439A - Mask and components thereof - Google Patents
Mask and components thereof Download PDFInfo
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- CN1735439A CN1735439A CN 200380108396 CN200380108396A CN1735439A CN 1735439 A CN1735439 A CN 1735439A CN 200380108396 CN200380108396 CN 200380108396 CN 200380108396 A CN200380108396 A CN 200380108396A CN 1735439 A CN1735439 A CN 1735439A
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- Prior art keywords
- cushion
- face shield
- pressure
- assembly
- mask
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Images
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
Technical field
The present invention relates generally to be used for the whole face mask of Noninvasive malleation feeder (NIPPA), continuous trachea normal pressure device (CPAP) and feeder.
Background technology
The malleation breathable gas is transported to needs of patients certain interface between machine and patient from feeder.Usually adopt and be placed on the patient interface that endotracheal pipe is made the invasive air feed.When the 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 that is formed by shell or framework.This face shield also comprise usually can be comfortable the facial part of contact, cushion for example, this cushion is fixed in the edge of shell or framework.Face shield is usually with wearing tool, and one group of elastic webbing for example is fixed on the appropriate location of patient's face.Improve the comfort level of face shield, when face shield need be worn some hrs, be the challenge to the mask designs personnel particularly always.
Unless each end user is customized face shield, because face shape is very inequality, so most of device of face shield is a kind of compromise design.A kind of mask designs may cooperate sub-fraction patient group's nose shape (for example Roman nose bone) very much, but another part crowd with difformity nose (for example short bridge of the nose bone) just can not finely be cooperated.Designing a kind of face shield, to seal the bridge of the nose well partly be difficulty especially, because this facial zone is impression especially easily.
Wrinkle on the face shield cushion are being worn the time spent for a long time, may make patient's face very uncomfortable.Although use cushion in addition, still can experience the edge of mask frame by cushion, the face that faces toward the patient forms uncomfortable surface, when particularly cushion is compressed.
In some cases, face shield is fit to comprise the ventilating slit, this exhaust apertures except that other many things and, allow controlled gas leakage to flow out face shield, so that prevent from face shield, to accumulate CO
2For example, the joint portion between face shield and patient skin, also exist carelessness or inward mask leakage unintentionally.Adopt the low or zero face shield that is not intended to gas leakage of formation can improve the operation that feeder particularly responds the middle-and-high-ranking control algolithm of feeder of respiratory air flow signal.
During sleeping, the patient may move.In addition, because for example swelling, the shape of patient's head may change during sleeping.Although the face shield patient that fits very much when beginning to connect, because night is this moving, face shield is fitted just not so good subsequently.The prior art face shield generally includes elasticity and wears the tool band, and these bands can shorten or extend, and perhaps can reconfigure on head, makes face shield get back to the little position of comfortable gas leakage.
During treating, can change by what feeder provided and keep pressure.Some successive 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 in patient's breathing cycle keeps pressure, the higher pressure of keeping for example is provided when sucking, and when breathing out, provides the lower pressure of keeping.Elasticity is worn the tool band must be configured to be suitable for this pressure of keeping.If resilient band arrangements becomes to be fit to high pressure, such danger is then arranged, promptly elastic webbing stretches tight too tightly and uncomfortable when low-pressure.
Summary of the invention
An aspect of of the present present invention provides a kind of low face shield of comfortable gas leakage that is used for the 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 helps to improve patient's compliance and/or treatment: wear tool, comprise not flexible basically and/or the band that can finely tune; And/or face shield and/or cushion, these face shields and/or cushion comprise various parts so that enhancing/improvement sealing, and/or applying patient face select the position.
In the following description, adopt following anatomical terms:
Side: from the foot to the head and surpass on the direction vector of these parts.Nose is in a side of lip and chin.
The tail side: also surpassing on the direction vector of these parts to foot from the head.
Anterior: as also to surpass on the direction vector of these parts anterior from the health rear portion to health.Nose is in the front portion of ear, and face shield is in the front portion of nose.
Rear portion: on the direction vector that points to from the health front portion to the health rear portion.Ear at nose the 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 the crown band.
Before and after to face: a face is parallel to the face that passes head, foot, posterior spinal and tip of the nose.
Nape: relevant with cervical region rear portion (muscle).
Occipital bone: relevant with 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 of the cardinal principle half Semen Armeniacae Amarum size of the cheekbone main body of zygomatic process (strictness say so).
Inner eye corner: near the point of an appearance friendship up and down of the bridge of the nose.
Describe these and other aspects of preferred embodiment below in detail, perhaps can from these explanations, obviously find out these and other aspects.
Description of drawings
Describe illustrative embodiment in detail below with reference to accompanying drawing, identical numbering is represented identical parts among the figure, and these accompanying drawings are:
Fig. 1-5 illustrates 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 mechanism and the principle that changes belt tension according to the air pressure that flows to the patient;
Figure 16-35 illustrates another embodiment of the present invention;
Figure 36-40B illustrates one embodiment of the present of invention, in this embodiment, can effectively seal the both sides of patient's nose;
Figure 41-53 illustrates another embodiment of the present invention, can strengthen the framework/cushion of sealing shown in the figure along patient's nose both sides;
Figure 53 A-53G illustrates another embodiment of framework, in this embodiment, forms fin and supports cushion;
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 56-56F 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 a curve chart, and the mechanical property of first embodiment of the invention, MIRAGE cushion and ACLAIM cushion is shown respectively;
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 a curve chart, and the mechanical property of the present invention's first and second embodiment cushion assemblies, MIRAGE cushion, ACLAIM cushion is shown respectively, and has compared the mechanical property of three kinds of cushions;
Figure 61 is a curve chart, and the present invention's first and second embodiment cushion assembly operations under pressure are 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 the selectively changing cushion;
Figure 70-79 illustrates 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 that is suitable for as the foam material of all embodiment compliant members of the present invention.
The specific embodiment
Following detailed description of the present invention comprises and discloses many different parts that are applicable to the various embodiment of face shield assembly.Should be understood that to any parts of embodiment explanation can with one or more parts couplings among another embodiment.
Wear tool
A. non-retractable band
Fig. 1-5 illustrates an embodiment of mask system, comprises face shield assembly 15 and wears 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, face shield assembly 15 is shown, wears the use of assembly 20 with illustration as an example.This face shield assembly 15 can replace with any suitable breathing mask, as those of ordinary skill as can be seen.
In order to make face shield assembly 15 fix in position, wear assembly 20 utilize before and after to being with 25 and level band 30.This level band 30 is horizontal arrangement substantially, and encase patient's head around.Each end 31 of each level band 30 is connected in face shield assembly 15.In the detailed description below, 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 passes the cushion region that musculi colli enters the skull bottom, and this regional thing total usefulness 36 in Fig. 2 is represented.
Before and after to being positioned at the terminal point of level band 30 substantially with 25 rearward end 40, thereby be positioned at the postmedian zone of patient's head.As shown in Figure 1, be quite wide in the front and back of patient's head Background Region to width with 25, for example be front and back about twices to 25 remainder width.This surperficial degree increase is favourable, because it helps when pressure change or belt tension change, prevents that this band from reining in a lot of fat or the very soft rear portions into patient's head.Certainly, being with 25 should be too not wide and/or very thick, makes it become uncomfortable.The most handy nice and cool material of this band is BREATHOPRENE for example
TMMake.
Before and after to being with 25 for example to stretch out from level band 30 and to stretch out from rearward end 40f, cross the skull summit that general usefulness 45 is represented, and cross general substantially from the inboard with the forehead (see figure 2) of numbering 50 patient's heads of representing.These front and back describe in detail as following to having the front end 55 that is connected in face shield assembly 15 with 25.
Each lower end 65 of crown band 35 is connected in level band 30 by bind and/or bonding agent.Perhaps, level band 30 can with one or more buckle parts be connected in crown band 35 and/or front and back to be with 25 the two, these button parts can be regulated between one or more band portions.Perhaps, one or more bands of wearing assembly 20 form with unitary piece of material.
For safety and the comfortableness that keeps face shield assembly 15, the band of wearing assembly 20 is preferably formed as and is not flexible basically.In other words, have some flexibilities, yet these bands can not stretch significantly preferably.These bands have enough big toughness or rigidity, thereby can keep its shape.The imagination material of making band comprises polrvinyl chloride (PVC), leather, polypropylene, perhaps polyurethane.Certainly, also can use other materials.For example, the other materials that sees fit can be the big strap of intensity, and these bands also can consider to serve as a contrast felt materials, and to increase patient's level of comfort, other variation comprises perforation or knockout, so that by these band heat radiations.
B. Dai fine setting
1. first embodiment
With reference to figure 1, preferably will wear assembly 20 by this way and be connected in face shield assembly 15, making can be with respect to the position of the band adjusting range shade assembly 15 of wearing assembly 20.Face shield assembly 15 comprise frame assembly 70, form cushion 75 interface or that contact with the patient and be inserted in frame assembly 70 with the patient and cushion 75 between cushion supporting member 80.Cushion supporting member 80 comprises that the 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.Usually ell 85 loose grounds are connected in the hole of cushion supporting member 80.This rotation ell comprises the connector 86 that unclamps fast, and this connector is connected in the air delivery pipe (not shown), and this carrier pipe is connected in for example source of the gas (not shown) of air transport device again.
Fig. 3 illustrates the front view of face shield assembly 10.As can see from Figure 3, chassis 95 comprise many from the chassis 95 finger member of stretching out 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 that stretches out from level band 30 each ends.Nut 110 can be fixed in 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 given about 2 to the 40cm water column in the high pressure limit, and it is apt to act on facial power.
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.Hole 91 and 120 shape and the shape of threaded portion 105 are complementary.For example, hole 91 and 102 has rectangular shape substantially, when adjusting nut 110, can prevent that threaded portion from rotating thus.Though not shown, the end of threaded portion 105 also comprises the parts with slot, thereby help to prevent the rotation of threaded portion 105.
Fig. 4 is a side view, the clearer connection that illustrates between each level band 30 and the frame assembly 70.In addition, Fig. 4 illustrates, and each finger section 115 for example is connected in the lateral part 96 and 97 on chassis 95 movably rotationally.In this specific example, two finger section 115 in top are connected in cross bar 125, and two finger section 115 of bottom are connected in similar cross bar 130.Therefore, two top fingers and two bottom fingers on each side, chassis can move respectively harmoniously, see that from the distribution viewpoint of power this is favourable.Yet should consider that 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 that stretches out from each level band 30 ends 31 passes and is formed on the receiver hole 120 that two finger section in bottom 115 form.Like this, when fastening nut 110, will be stretched in any the relaxing on the level band 30.After all lax of tensioning, further tightening of nut 110 will cause two finger section 115 in right-hand side bottom to rotate (watching from above) with respect to cushion supporting member 80 clockwise directions.Two parts in left-hand side bottom are rotated counter-clockwise direction when watching from above.But cushion supporting member 80 is being deformation near the side part 82 of finger section 115 at least.Because this deformation, this side part 82 can apply power to the appropriate section in the cushion 75, thereby compresses the both sides of patient's nose.
As shown in Figure 4, but cushion 75 can form one by for example finger 115 with cushion supporting member 80 flexible or deformation, thereby better mates the profile of various faces.Need to compromise between the very soft dead-soft cushion supporting member of manufacturing, very soft is facial in order to fit better, and dead-soft causes the facepiece interior volume very difficult with this feasible measurement trend volume of each air-breathing undue change (for example greater than 20 milliliters).The conventional silicone rubber of about 1-3mm thickness is suitable.
Fig. 5 is a rearview, and face shield assembly 15 is shown, and in this assembly, two finger section 115 in top in patient's face left side can be pressed on the side part 82 of cushion supporting member 80 by hand push.The power that two finger section 115 in top act on cushion side part 82 can make cushion 75 that deformation takes place, and makes it can push the side of nose, can admit difform nose thus, and strengthen the sealing property of cushion 75.
In Fig. 1-5, but the deformation behavior of two sides 82 of the tension force of band and supporting member 80 can make finger rotate together and pushing simultaneously, can push both sides and a part of patient's face of nose thus.Therefore, utilize the independent rotation can the irregular face of adapted shape.This also helps the active force uniform distribution to unclamp the zone of high contact force thus on face.
Fig. 5 illustrates increases the tensile result of top bar (not shown), and tensile this increase causes oppressing patient's nasal bridge region.For the treatment of two pressure, this is useful especially, makes under low-pressure, only acts on very low power, and under high pressure, acts on high power, and this helps to improve level of comfort and sealing.Wear tool with the non-elastic material manufacturing, help to prevent " piston action " of face shield on face, that is, during two pressure therapies, when high pressure, lift away from face and/or when low pressure, enter face.
In the embodiment shown in Fig. 1-5, be formed on two top finger component invading the exterior on 95 each lateral parts 96 and 97, chassis and be shown and be connected on arbitrary tape member of wearing assembly 20.Yet the location of this top band portion can be shown in imaginary line among Fig. 2 135 and 140.Specifically be that imaginary line 135 expression top band portions are connected in the state at crown band 35 middle parts.Imaginary line 140 expression top band portions are being worn the state that each side of tool is connected in level band 30.
2. 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 optionally is connected in the second coupling part C2.This second coupling part C2 is fixed in bottom band LS and top band US.Upper and lower band LS, US can be tensioned to the degree that they are pressed on framework 70 lateral parts 82, can apply inside power thus on cushion 75, thereby in the both sides of side seal patient nose.This upper and lower band LS and US are fixed in framework 70 (as shown by arrows) adjustablely, thereby can locate the zone of internal force effect better.In this embodiment, but the making of the side part 82 usefulness shape-changing materials of supporting member 80, and the summit is more inflexible.
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 that suffocates.Fastener 815 is unclamped in configuration fast, wears tool so that the patient very property takes off, and 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 that is in local open position, and Fig. 5 E illustrates the quick tripping-gear of opening fully.
Comprise a pair of strap end portion 820A and the 820B that is used for face shield assembly is remained on patient's head with 820.One of them strap end portion for example 820B can be connected in an end of the mask frame that is positioned at the fixed position by for example groove 821, can avoid the length variations with 820 thus, multiple take off or relay on during face shield assembly, this length variations may take place.Another strap end portion 820A disposes and is constructed to adjustable.Certainly, all be adjustable with two ends of 820.Curved bel 820 makes strap end portion 820B pass groove 821, forms an available rivet 822 or the fixed ring of other securing members.
Can come accommodation zone 820 by configuration adjustment assembly 825.Specifically be, shown in Fig. 5 F, this adjusting part comprises rectangular prism 830 substantially, and this prism has the band receiving slit 835 that passes its whole length.This groove has the opening 840 that is presented on the prism end face.This prism has top 836, lower part 837 and screw rod 845, illustrates as Fig. 5 G is clear.The primary importance of coarse adjustment strip length can be taked to be suitable in this top and lower part 836 and 837, strap end portion 820A can be pulled through the length of groove 835 in this position.Be suitable for the second position of fine tuning, this top and lower part 836,837 will combine, and make screw rod 845 contact with strap end portion 820A, thereby anti-leukorrhagia stopping is by groove 835.Screw rod 845 will make strap end portion 820A move when rotating, thus tensioning or loosen and wear tool.This top 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 first gear parts 850 that extends through prism 835 length.Shown in Fig. 5 H, first gear parts 850 engages second gear parts 855 with the right angle again.Second gear parts 855 has the cylinder button 860 that is fixed in the above.Rotate this cylinder button 860 and just can rotate second gear parts 855, drive first gear parts 850 thus, thereby drive screw 845.Depend on rotation direction, be with or pull out or push this groove, length that thus can the fine tuning band.
C. the pneumatic pad of inflatable gallbladder-gas bag and occipital bone
1. first embodiment
With reference to figure 1, wear assembly 20 shown in the figure, comprise the inflatable gallbladder of special shape shown in the figure, this gallbladder will be called follows the usual practice as wearing assembly 20 front and back to " gas bag " 145 with 25 configurations.This gas bag 145 is configured in the gamut of mask pressure constant relatively band masterpiece to be used in patient's face.This gas bag 145 is a kind of active components, can use the gas work done, thereby under higher pressure, face shield is drawn to face.Gas bag 145 is by the silica gel tube 150 of minor diameter and the pressure communication in the face shield, and this silica gel tube is connected on the gas inlet-outlet of this assembly on the face shield assembly 15 or close.In this example, this pipe 850 is configured on the ell 845, before and after belt tension on 25 form by bleed pressure is local by gas bag 145 at least, this tension force can make under elevated pressures is with that tensioning more/more multidigit is moved, and is with not too tensioning/or littler displacement and can make under lower pressure.
Though gas bag 145 is expressed as preferred embodiment, can adopt other mechanisms to obtain the variation of belt tension/displacement, these mechanisms comprise power driven system and mechanical system.When face shield pressure increased, the increase of gas bag pressure was inflated to more as sphere gas bag, shortens before and after making its thus, thereby pull strength is backward acted on the cantilever 90, and face shield is pressed on the face more reliably.
As first approximation, the direction power backward that is produced by gas bag or cantilever 90 is proportional to mask pressure.When nut 110 was tightened, its proportionality constant was bigger, made that this gas bag can easier elongation under certain mask pressure.Therefore, gas bag 145 can be seen a kind of compensation mechanism as, if regulate this mechanism like this, make under a pressure, and mask seal, then face shield will be at all pressure lower seals, and the air pressure in the balance face shield always.
When pressure increased Δ P, gas bag was expansion Δ V, the Δ V Δ P that does work thus, and the effect of counteragent thus pulls back a segment distance with the junction point on the cantilever 90 91.
Though only on the band of top, form gas bag 145, also can comprise the other gas bag of formation on the level band 30 at remaining band.Yet in this embodiment, on the band of bottom, do not add any gas bag 145 because patient's lower jaw and lower lips move towards to form waveform naturally, this situation is similar to the effect of bag 145 to a certain extent, thereby in the whole operation pressure limit, in this zone, form good motion.In other words, General Logistics Department's sealing mechanism is different at the bottom of the sealing mechanism of mask top and the face shield.For the 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, and are because the face structure of nasal bridge region is a bone, very hard.
2. the details of gas bag
Illustrated in general sense gas bag 145 to describe below referring to Fig. 6-15A, these explanations have been described in more detail the more specifically principle of gas bag.
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 the calculating.With on power be f.In Figure 10, gas bag 145 is laterally cut in half, and a pair of rigid plate is fixed in this tangent line, and one of them rigid plate is represented with numbering 155.Connect these two plates by rigid rod 160.Power on rigid rod 160 also is f.
Suppose that axial surface tension force (power/unit length) is t on the band of top.Because assembly is change in time, thus act on the visible plate 155 power its make a concerted effort to be necessary for zero.These power comprise the power 2tW that acts on the left side, act on the power 2pWh on the right and act on power f on the rigid rod 160 of the right:
2tW＝f+2pWh (1)
If for p＞0, there is not any surface tension on tape, then the top surface of gas bag 145 and lower surface will form cylinder (θ=pi/2) together.When being with 25 to do the time spent being subjected to tension force, it is that the cylindrical incomplete symmetry of r is fan-shaped that the surface will become two radiuses, shown in the cross section of Figure 11.
The intersecting lens of two surfaces and band is positioned at poised state, does not promptly act on any clean power on it.Because it is incoherent exceeding the surface of the gas bag 145 of junction point, so can be the integral body of all the other cylinders replacements of r with radius above junction point.
[0093] cross section of top or lower surface is a circular arc, and its radius is r, and is 2 θ facing to the angle in the center of circle.
According to the simple geometric figure, the angle between the extension line of gas bag 145 top surfaces or basal surface and band also is θ, as shown in figure 12.Because the net effort in the coupling part is zero, so we obtain:
f＝2Wt cos(θ) (2)
Can find out obviously from Figure 12 that [0095] another constraint equation is:
h＝r(1-cos(θ)) (3)
At last, if gas bag 145 has length L of evening up (distance between the band), then the girth of circular arc is:
L＝2rθ (4)
Therefore four company's cube journeys are arranged, five unknown number p, h, t, f and θ and two constant W and L.F separate for:
f＝pWLcos(θ)/θ (0＜θ＜π/2) (5)
[0097] note following characteristic:
(i) if gas bag even up, i.e. θ → 0, then any normal pressure will produce infinitely-great power;
If (ii) θ=pi/2, promptly gas bag is cylindrical, and then f is zero for all p.Neglect flexible lateral characteristic, W and L play same purpose in the generation of power.The two one of double to double with exerting all one's strength.
[0098] power of Chan Shenging is with the length variations of gas bag 145.As can be seen from Figure 11, determining by following equation of gas bag two ends apart from x:
x＝2rsin(θ) (6)
The r that replaces in the equation (4) can obtain:
x＝Lsin(θ)/θ (7)
Notice again:
f＝pWLcos(θ)/θ (5)
List table 1 with top equation.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 is represented power " f " (see figure 10) that produces, 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)/ |
| 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 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) that draws.
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 fair fully gas, rigidity is positive 4pw/ π).Table 2 has added the rigidity of last table.
Table 2
| θ (degree) | Distance between the band (maximum percent) | The power (coefficient of pWL) that produces | 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, then Dai tension force increases with pressure is linear.
For any given geometry, the power of generation is proportional to the regular length and the extension of gas bag.
For any given pressure, when gas bag was positioned at its static length, the power that is produced was infinity, very fast then decline.
As an example, be connected in 20cmH
2The gas bag of the 6cm length * 5cm width of O pressure produces the power of about 0.633kgf when shortening 0.5cm, when shortening 1.0cm, produce the power of about 0.300kgf, when shortening 1.5cm, produces the power of about 138g.
This power has the result of very strong dependence to be to length, will make with screw tension headband can produce the power of any requirement under setting pressure.
At 20cmH
2Under the pressure of O, air pressure will apply the power of 1400g, and at 5cmH
2Under the O pressure, the only power of 350g will be applied.Can suppose,, need apply power, perhaps apply the power of 1820g than this power high 30% in order to seal.
With reference to Figure 15, supposing 1) centre of moment C is positioned at the position of 4.5cm above the face shield bottom, perhaps is positioned at the position of the 7.5cm below the top; 2) the bottom band is connected in the position of about 3.5cm above the face shield bottom, and perhaps 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 the about 15 times of close centre of moments of the connection of top band, so the bottom band bears 15/16 of load, the power that only stays 100g is supported by the top band.
The wide gas bag of 6cm length * 5cm is arranged on the band of top.This gas bag is connected in face shield with pipe 105.When its length was reduced to 4.35cm, this gas bag was at 20cmH
2O pressure will produce the power of 100g down.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 will make the elastance of wearing tool add the elastance of gas bag.
For example, suppose 5cm wide * long gas bag and the elastance of 6cm is that traditional ResMed headband that getting well of 10cm/kgf washed is installed in series.Gas bag is at 20cmH
2During 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 total its (part) elastance of system is 14.3cm/kg.The elastance of whole system is controlled by the tradition band.
As another example, from 5cm wide * the long gas bag of 6cm, pressure is 20cmH
2O.Therefore, length still is x
0=4.35cm, the power f of generation
0=100g.This gas bag still is the band of 0.1kg/cm, i.e. spring constant K with elastance
StrapThe band series connection of=10kg/cm, next step is to determine to be reduced to 5cmH at pressure
2Occurrence during O.
By the power of extending band generation and the relation equation of gas bag length x be:
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.
When not having gas bag, the unwanted belt tension that is supported by the bridge of the nose is 75g.During with non-retractable or inflexible headband basically, the correct gas bag of regulating can drop to this power zero usually.But for very dark headband, unwanted belt tension is 45g, or during without gas bag half is more.
2. second embodiment
Figure 16-35 illustrates another embodiment of the present invention.
Total with numbering 410 face shields of representing with wear assembly shown in Figure 16-18, be expressed as the state that is worn on the 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, so that regulate the joint of wearing tool 414.
In a kind of preferred form, the 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 provides a kind ofly meticulous connect airtight and does not cause pain, uncomfortable or make skin injured.Specifically be that the facial part 420 of contact is designed to can be around the bone parts sealing of nose.For fear of injured skin, if contact facial parts 420 acts on average pressure on the face greater than facial capillary tube mean blood pressure (being about 20mmHg pressure usually) without any a part, this is best.
In general, contact facial parts 420 generally is shaped to and is pressing the height that both sides (being pressed in the top of nose cartilage) that nose dyes bone highly are positioned at inner eye corner.The both sides that contact facial parts 420 is formed on bridge of the nose bone form towards interior sealing member.Yet contact facial parts 420 is designed to do not pressing the both wings of nose, and method is directly to pressurize at cartilage, perhaps indirect nigh software component pressurization.In addition, contact facial parts 420 does not preferably contact eyes, eyelashes, perhaps the tear stains mechanism on the 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 admit the bridge of the nose (nasion).Form teat 426, prominent with the front that cooperates frontal bone.Form second breach 428, so that admit buccal (the last volume that is cheekbone is prominent).In addition, form second teat 430, forming the 3rd breach 431 to admit the 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 does not have viscosity again or the decortication characteristic, then is best.Usually the silicone rubber skin is bonded on the foamed materials with binding agent, and is wrinkling with respect to foamed materials to prevent this skin.
The main part 422 supporting ells 430 of mask body assembly 418, anti-valve and the breather that suffocates.This main part can quite optionally make 418 deformation of mask body assembly or bending, this main part also play location and constraint mechanism effect with respect to the framework 436 of face shield assembly 412, so that prevent the framework slippage.At this mask body assembly 418 shown in the sectional view of the plane graph of Figure 33 A and Figure 33 B, in a kind of preferred form, these main part 422 usefulness silicone rubber are done, and with contact face shield part 420 molded forming, and in abutting connection with face shield contact portion 422.
The bottom of framework 436 divide 438 be generally " C " shape or the heart moon shape, this top portion 442 is generally that Darts form or herringbone.
Soft top portion 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 identical shaped aluminium flake of a pair of 100mm * 20mm * 1mm.This framework 436 can be with four rivet rivetings together, perhaps can with other known methods for example Method for bonding combine.
In Figure 32, the framework 436 that illustrates separately comprises the fork-shaped carriage 444 that is contained on each side part 440.Each carriage 444 usefulness aluminum or other inflexible basically material.Length along side part 440 has some holes 446, and these holes are suitable for receiving bolt, and analog bracket 444 thus.Carriage 444 can be regulated by the method for unclamping bolt, adjusting angle and bolting on respect to the angle of side part 440.Can be in the different holes by being bolted to along the position of side part bracket 444.Two carriages 444 not necessarily are contained in identical relative position along side part 440.Like this, can revise a little for any unsymmetry of patient's face.On each side part, fix a carriage 444.This carriage 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 is fixed between the side part 440 and/or top portion 442 and facial contact portion 420 of mask body assembly 418 in operation.It is thick that this liner is about 1-2cm at the top, is reduced to zero gradually in half position of about face shield.In addition, the thickness of this wedge is reduced to zero gradually from external-to-internal.This wedge is generally used incoercible material.This wedge is used in the top of mask body assembly 418 with additional masterpiece, thereby helps sealing.In addition, this wedge is at the both sides of nasal bone compressing face shield body assembly 418, adds bigger pressure at the outward flange of mask body assembly 418 than inward flange.
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, integral body is worn the end of assembly.But in other embodiments of the invention, these bands can be the single bands that link together of selectivity in position.With 456,458,460 can with soft general non-retractable plastics for example the polypropylene board of 1mm make, these plate selectivitys become with froth bed, felt 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 cooperate patient's head, but when being subjected to 2kgf tension force, the elongation of these bands generally can not surpass 1-2mm.
Bottom occipital bone band 456 but passes through on musculi colli below occipital bone, 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, reins in the basal part of the ear preventing.
A pair of inflexible screw rod 450 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 be near external auditory meatus in operation, and stretch 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 releasably being engaged in the carriage 444 that is contained on the mask frame 436, shown in Figure 16,17,19 and 20.The auricle 460 that this bar 450 utilizes rotating connector 470 to be connected in to wear tool 414 is shown in Figure 19,23 and 24.(first and second positions of rotating connector 470 are shown in Figure 24 and 25 respectively).Like this, just, relative angle position that can adjusting rod 450.Along threaded rod travelling nut 468, can accurately regulate framework 436 and the tension force of wearing on the tool 414.This configuration also forms quick back-off assembly.Because framework 436 comprises soft bottom and divides 438 and top portion 442 that so regulating them, when seeking the cooperation that the patient is more suitable for, framework will carry out bending according to the position of nut 468 on bar 450.
Inflatable occipital bone air cushion 416 be with 456,458,460 to form the power transmissions relation, and in operation, be positioned at below the band assembly 452 and the back of head, generally be positioned at the occipital bone zone.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 the occipital bone air cushion 416 is identical with air pressure in the face shield assembly 412.When the pressure of face shield assembly 412 increased, this occipital bone air cushion 416 was just inflated, and this causes wearing tool tension force increases simultaneously, and it is facial to prevent that face shield assembly 412 breaks away from, and leaked gas.So just, can be during different mask pressures, the moving of buffering suface shade assembly 412.
Occipital bone air cushion 416 is designed to have enough big area (A
Bladder), make with the occipital bone air cushion in air pressure (P in 416
Bladder) in conjunction with the time, this air cushion will be offset head and be acted on the active force worn on the tool band 456,458,460 (i.e. the power on the bag 456,458,460 of acting on that is caused by pressure in the face shield assembly 412).In general, the area of occipital bone air cushion 416 should be done quite greatly, so that a power is provided, this power surpasses 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.Yet, in other embodiments of the invention, can utilize the inflation and the venting of the parameter control occipital bone air cushion 416 except that mask pressure.For example, the gas leakage of pick off 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, so that find the leakage rate of air-flow.When determining that gas leakage is very big, will make pneumatic pad 416 inflations of occipital bone.On the contrary, when gas leakage is confirmed as relatively hanging down, can make the pneumatic pad venting of occipital bone.Pressure with the pneumatic pad 416 of gas leakage detecting sensor control occipital bone, can make and wear the amount of tension that tool 414 remains on minimum, this amount of tension also can the face shield tool 412 sealings that keep face, and uncomfortable, the skin damage and the over-tension that help to alleviate the end user are worn the inherent other problems of tool.
In addition, may wish on the tool 414 to adopt more than one occipital bone air cushion 416 wearing, if adopt the pneumatic pad 416 of more than one occipital bone, then 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 a plurality of occipital bone air cushions 416 can be inflated and exit independently of one another.This mode can be easier the unsymmetry of compensation patient face because can be partial and wearing working tension in the tool 414 in a place that only needs.When therefore the pressure in face shield assembly increases respectively or reduces, a plurality of pillows are taken offence fill up 416 inflations or venting, perhaps can make these pneumatic pad gas and venting by sensing and control system, these sensings and control system are based on the air leakage work of measuring.
In another embodiment of the present invention, can adopt marmem (SMI) silk for example MIUSCLE WIRES (Mondo-Tronics, Inc, San rafael, CA USA) makes more sensitive tension part, this alloy silk shrinks when galvanization.(systole response that produces when usually, switching on the pond is because electric current causes the heating of alloy silk by it.If) use such parts to reach sensitive tension adjustment, then need to dispose controller separately so that make this alloy silk and the synchronous contraction of mask pressure increase.
Other suitable sensitive tension parts comprise servo motor and " artificial muscle " that form with the biomimetic material.
D. algorithm
For example just be inflated to predetermined tension force at the beginning according to occipital bone air cushion 416 embodiment illustrated in fig. 16.In one embodiment, with mask seal the method that is fixed on patient's face comprise: with of the rear portion configuration of occipital bone air cushion against head and/or cervical region; One or more bands are crossed or by this occipital bone air cushion, perhaps formed the part of this air cushion, these reach out, and are connected in face shield; Use pressure P
BladderAir pillow moral integrity pad, this pressure are mask pressure P
MiskAffine function
P
bladder＝P
0+A
maskP
mask
P wherein
0Be normal pressure, can reach sealing, A when the minimum predetermined working pressure even as big as making face shield
MaskIt is back less area in the forward direction contact area between contact area and occipital bone air cushion and head rear portion, front between occipital bone air cushion and the 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 deviation adjustable amplifier; The output of amplifier is added on the pressure source of voltage controlled; With the gas inflated occipital bone air cushion in the above-mentioned pressure source; Regulating 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
PtBe V
Pt=K
PtP
Mask, then the 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, the band with the pneumatic pad contact area of occipital bone forwards to projected area be A
Bladder, reaching the needed power of sealing at zero pressure is F
0, then amplifier is exported following output voltage:
V
out＝F
0/A
bladder+A
mask/A
bladderK
c/K
ptV
in
In certain embodiments, with pressure is that the pressure inflatable occipital bone air cushion of mask pressure affine function comprises: face shield is hose connection in first cylinder that comprises first piston by first, this first cylinder is connected in second piston in second cylinder by connecting rod again, and second cylinder is hose connection in the occipital bone air cushion by second; The above-mentioned connecting rod of bias voltage makes the inflation of occipital bone air cushion, and being charged to 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.
The device of mask seal on patient's face comprised: first group of telescopic band, face shield is led at these band rear portions from the beginning, and this band is tensioned, and is tensioned under minimum predetermined working pressure to make above-mentioned mask seal on face; Second group of non-retractable band, this band still from the beginning rear portion reach face shield forward, 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 is between first and second groups of bands, and above-mentioned occipital bone air cushion communicates with the air in the face shield is pneumatic.
In operation, first group of telescopic band is independent of mask pressure provides fixed constant force, and provides power with the mask pressure linear change by second group of pneumatic pad that takes up effect.These two power add together, form the power as the mask pressure affine function.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 is when identical with rear orientation projection's area of face shield contact face area, very near best allocation.
In another embodiment, with mask seal the device that remains on patient's face comprise: one group of rigid strip, this band rear portion from the beginning reaches face shield forward; Be placed on the pneumatic pad of semi-rigid elasticity occipital bone between above-mentioned band and the back of head, the pneumatic pad of this occipital bone is depressed in inner atmosphere, has the inside separation distance of non-zero between front walls and the rear wall; Flexible pipe is connected in face shield with the pneumatic pad of occipital bone.
The occipital bone air cushion can for example silicone rubber, latex or polyurethane be made with elastomeric material easily, fill this pneumatic pad with material springy, perhaps use one or more contained springs or external springs, can regulate the elasticity of this pneumatic pad, this material springy for example is silicon rubber foam, latex foam, polyurethane foam and/or PVC foam.Be sealed with being full of that the occipital bone air cushion can form comfortable inner spring in air and/or fluidic second elasticity, occipital bone air cushion is less than the exoccipital bone air cushion in this.
Depress in inner atmosphere, distance of separation is preferably about 2-4cm before and after between the occipital bone air cushion front and rear wall, be preferably 3cm, so that allow cervical region in suitable scope, to move, and increase within reason or reduction band active force, and when mask pressure increased, allowing had 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 medium approximately at band, when perhaps being 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.Usually this power is about 200-600g, and this depends on the characteristic and the cooperate degree of face shield.
When the tension force of band increases under higher mask pressure, the tissue of face shield cushion and back of head will be compressed.This will cause the pneumatic pad of occipital bone to expand, and will be inflexible because the pneumatic pad of occipital bone preferably specially is configured to, and take to by tensioning and be lower than its relaxed length and be compressed, so that be issued to the needed power F of sealing in low pressure arbitrarily
0So when the pneumatic pad of occipital bone expands, the elasticity of the pneumatic pad of this occipital bone will provide more and more littler power.Should adopt its area is A
BladderThe pneumatic pad of occipital bone compensate this loss of elementary spring recoil strength, this area A
BladderArea A greater than face shield
Mask
Do the time spent when the pneumatic pad of occipital bone is under pressure, and forward action is at the rear portion of head with when acting on tape backward, the flat lateral part of the part of this pad is contact zones, and can not contact this band at the sweep of band both sides.Only the area that contacts with band specifically is this area projected area forward, will produce useful belt tension.In fact, for adult's facial masks of typical sizes, for example adopt the about 17cm of side-to-side dimensions, the gas gallbladder of the about 11.5cm of size and thickness 3cm is suitable up and down.With the about 15cm of projected area side-to-side dimensions that band contacts, it is 150cm that the cholic effect of the about 10cm of size, thereby gas up and down is similar to area
2The effect of piston.Certainly these only are according to hobby and/or use and the example of change.
Framework
A. adjustable framework
1. 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 a cushion 172.These framework 170 usefulness many with 180 be bearing in the patient the head on, this band adopts non-retractable material basically, 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 the patient can accommodation zone.Basically the bar 175 of the bending of doing with rigid material is configured on the framework 170.
Configuration increases the governor motion 176 of framework 170 modulabilities.Specifically be, governor motion 176 comprises adjustment screw 190, and this screw can rotate, and makes 195 translations of wedge spare.This wedge spare can move along an imagination axle 196, this imagination spool be configured on framework 170 summits topmost headband 180 in line.Rotating adjustment screw 190 can make wedge spare 195 against curved bel 175 inner surface translations.In the another kind of structure shown in Figure 36 A, configuration wedge spare 195 makes it engage the outer surface of curved bel 175.In both cases, if wedge spare 195 moves to the top of framework 170 up, then the top surface 197 of this wedge spare 195 will be run into the inner surface or the outer surface of curved bel 175, this will make framework around be arranged essentially parallel to imagination axis 196 or with an axis bending of this dead in line.
This bending will make the side of framework 170 partly push the both sides of cushion 172, thrust can be acted on the both sides of patient's nose thus.On framework 170 bottoms, form adjustability, make face shield can easily be fit to dissimilar nose features.This adjustability can certainly form along the top or the middle part of framework.This adjustability can allow the contact force that the patient regulates to be needed under certain pressure.This framework can deformation, rotation or bending, so that adapt to the variation of pressure, makes that the power that is added on the face is constant basically.
2. second embodiment
Figure 37 illustrates the embodiment that is similar to embodiment shown in Figure 36, but comprises additional features.For example, Figure 37 illustrates hole 200, and this hole is by for example iron hoop 210 encirclements 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 first iron hoop 220, and this iron hoop is suitable for the iron hoop 210 that magnetic is connected in framework 170.This connector 215 comprises second iron hoop 225, and this iron hoop is adapted to pass through the magnet ring 235 usefulness magnetic that are formed on the rotatable parts 230 and connects this rotary part 230.
Figure 38 illustrates the more details of soft cushion structure.Specifically be, cushion 172 comprises for example foam and film 245 silicone rubber for example of bottom parts 240, and the former is configured in the inside of framework 170, and the latter divides 240 supportings by the bottom.
In Figure 37, amplified the distance between wedge spare 195 top surfaces 197 and curved bel 175 inner surfacies, thereby can easily see each parts.
Figure 39 illustrates the details of adjusting screw(rod) 190, wedge spare 195 and framework 170.Specifically be that adjusting screw(rod) 190 comprises threaded portion 250 and the disc-shaped part 255 that is formed on adjusting screw(rod) 190 adjusting knobs 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, so that receive the sub-body part 275 of wedge spare 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 spare 195 comprises groove 280, and this groove engages with the medial wall parts 285 that form cannelure 265.This wedge spare 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 the transverse groove 260.Then the partial screw threads part 290 of wedge spare 195 is transferred to the top of threaded portion 250, main part 275 at first is positioned between vertical part 272 and close inwall parts 285 inner ends of framework 170 bottoms 273.Guiding groove 280 then, and it is slided along wall components 285.Therefore when turning knob 260, this wedge spare 195 will seesaw in the groove 295 of framework 170.Two extreme positions of wedge spare 195 are shown in Figure 40 A and 40B respectively.
Figure 41-53 illustrates 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.Each embodiment can more regulate control among these embodiment, and more easily adaptive different nose shape patients' appearance changes.
3. the 3rd embodiment
Among the embodiment shown in Figure 4, knob 190 is connected in a tooth bar in operation, preferably be connected in a pair of tooth bar 191, and when turning knob 190, this tooth bar can in the opposite direction move.The far-end 193 of tooth bar 191 partly engages with the side of framework, it is outside when mobile that for example this framework is included in far-end 193 side direction, 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 pressurization thus to patient's face/nose both sides.
4. the 4th embodiment
In the embodiment shown in Figure 42 A and the 42B, film helps to seal little gas leakage, and therefore accurately adjusting is not important.In addition, the embodiment shown in Figure 42 A and the 42B can eliminate the perk from lower jaw basically.Figure 42 A and 42B also comprise other point of adjustment, can make face shield and patient's cooperation further obtain fine tuning thus.For example each knob 190 is connected in the part 197 that is configured on the cushion 172 in operation.
5. the 5th embodiment
In Figure 43 A and 43B, framework 170 is semirigid, and cushion 172 is contained on the compliant member 300.When increasing the tension force of band, the elastic reaction of 300 pairs of cushions of parts will help to seal the both sides of patient's nose.For example, compare with the rigidity of compliant member 300, framework 170 is quite inflexible springs.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 that keeps flat against framework 170, and this framework is gentle bent, 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 the protuberance 196 that adjusting knob 190 can make screw rod cammed surfaces 194 engage on the cushion supporting member, cushion is inwardly pressurizeed 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.This embodiment is similar to embodiment shown in Figure 1 on the principle, 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 embodiment shown in Figure 45, and Figure 46 B is the assembly drawing of embodiment shown in Figure 45.This embodiment is as other embodiment, the side of cushion more easily fitted have the various patients of different nose shapes.This embodiment facial configuration of can also automatically fitting is because with 180 each flank parts 305 that are connected in framework 170.The perk of face shield/cushion from the buccal can be reduced, and more uniform cushion pressure can be on face, reached.This embodiment also can replace cushion as a lot of above-mentioned other embodiment, perhaps uses movable cushion.
8. the 8th embodiment
Figure 45 A and 45B illustrate an embodiment again, and this embodiment is similar to 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 a partial exploded view, comprises the tongue 306 between two hinge portions that are configured on the flank part 305.This framework 170 comprises many grooves 307 that are suitable for receiving this tongue 306, can be adjusted to many discrete positions thus.
Figure 47 and 48 illustrates, when increasing the tension force of band, flank part 305 be sealed in position on patient's nose N gradually.
9. the 9th embodiment
Figure 49 and 50 illustrates another embodiment of governor motion, and this mechanism allows the flank section componental movement, for example rotates with respect to chassis or face shield assembly central frame.This governor motion comprises many holes 312, and these holes can receive the pin that is 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 a 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 promptly semirigid face shield chassis 512 and cushion/auxiliary frame 512 and 514 are separated, but can unclamp or fixing, as mentioned above.In general, face shield chassis 512 structure and be configured to be connected in face shield and wear tool (not shown among 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 make that cushion/auxiliary frame can be with respect to face shield chassis 512 motion, perhaps deformation, thus a small amount of adjusting is provided when making face shield assembly 510 coupling end users 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 fixedlyed connected with 518.The size of cushion/auxiliary frame 514 be decided to be can play a part oral area face shield, nose face shield, oral area-nose face shield or any and patient treatment agreement or with any other compatible type of mask of patient treatment agreement.
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 of bonding station and the part of cushion/auxiliary frame 514, regulating wheel 530 is shown, this regulating wheel is contained in the regulating wheel standing part 542, and engages the protuberance 528 on the auxiliary frame 518.This regulating wheel 530 comprises threaded rod or rivet 546, an end of this threaded rod be fixed on that the end user turns 548 in twist screw rod so that form hands, and its other end connects or is configured in the hole 544.Thinner or the thinner part of wheel 530 contacts with protuberance 528 in Figure 52.Therefore, cushion/auxiliary frame 514 is in unstrained state basically, and this state is not subjected to the influence 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 not enough.
In order to regulate cushion/auxiliary frame 514 with respect to skin 550, the end user can rotate regulating wheel 530, and what make regulating wheel 530 shifts to protuberance 528 than thickness portion, and contacts 528.One when thicker part contact protuberance 528, and auxiliary frame part 514 is just crooked, thereby cushion 516 is moved to patient skin, and perhaps more close patient skin can be regulated sealing load thus and/or regulate and cooperates.Figure 53 illustrates regulating wheel 530, and this regulating wheel is in it makes cushion/auxiliary frame 514 to the skin bent position, thereby can eliminate gap and/or improvement cooperation/sealing therebetween between skin 550 and the cushion part 516.
Except that above-mentioned governor motion, some part intensity on face shield chassis 512 is reduced, so that make that 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, perhaps adopt different materials for example to adopt Merlon, perhaps be configured to different geometries and for example add the enhancing rib, perhaps add constraints, for example, perhaps adopt the integrated processes of these methods with the tension force of wearing tool.
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.Yet in other embodiments of the invention, in face shield chassis and/or cushion/auxiliary frame, comprise positioning element, so that make cushion/auxiliary frame with respect to the face shield bobbin movement.In addition, face shield chassis and cushion/auxiliary frame can not form parts that can separate or discerptible, as described in other embodiment.
B. fin
1. first embodiment
Figure 53 A-53G illustrates two closely-related embodiment of the present invention.Each embodiment structure and be configured to help to improve lateral seal power in the nose both sides.These embodiment partly are useful especially at the bridge of the nose.But also can be used in the zone of for example close nose in other zones and mouth lower part.
Figure 53 A-53C illustrates an embodiment, and in this embodiment, framework has leg-of-mutton shape substantially, and this belfry becomes the face shield cushion that can support full-face in this example, though this framework is suitable for the framework as the nose cushion.This framework 600 can comprise other shapes Any shape that plays interface interaction that is for example circular substantially, trapezoid or suitable patient's presumptive area.
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 basically end of wearing the tool band.This wears the tool band can be connected in arbitrary hole in the hole 615.In addition, these holes are formed on the sidewall 617 at connector interface 610.
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.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 bigger or entire portion extension along patient's nose dual-side.This fin 620 is constructed in the respective grooves or groove that can be contained on the facial cushion (not shown) or form outside cushion.Each fin comprises one or more holes 625, and this hole helps to form lock bolt between fin and cushion, and can weight reduction.
In use, fin 620 forms lateral-supporting to a certain degree, thereby helps to keep the excellent sealing to the patient both sides.For example, when increasing the tension force of band, common pad will trend towards side direction and outwards form waveform, increase the probability of infringement cushion sealing or comfortableness thus.Form fin 620 and help also to prevent that cushion from outwards rippling, thereby help to keep sealing the nose both sides.
This belfry becomes and has flexibility, thereby can be around axis A rotation, bending or deformation.Like this, when the tensioning headband, this framework 600 can make fin inwardly move around axis A motion thus, is pressurizeed in patient's nose both sides.In addition or according to another kind of mode, when making face shield lateral curvature, rotation or deformation, shown in the arrow of Figure 53 C, the top portion 601 of framework 600 will be to the bending of patient's nasal bridge region, rotation or deformation, shown in the arrow of Figure 53 B.In original position, top portion 601 is bent away from patient's face.Therefore, regulate the sealing that the sidepiece band can strengthen nasal bridge region, thereby do not want the top band.
When face shield during around main vertical axis A deformation, framework trends towards becoming straight 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 mainly is, when framework during around an axis bending, the frame part around another axis bending will bear bigger strain.Therefore, in order to reduce the strain in the material as far as possible, it will make inherent crooked the change directly, change to the position of low strain energy.When face is left in intrinsic bending, make intrinsic crooked the change directly will make the more close face of that part of face shield.
As can be seen, by changing incoherent plain bending position and direction, can make any requirement of framework partly shift to or move apart satisfactory as curved frames on a known plane.
Alternatively or add, framework 600 comprises one or stop the line 630 of strength reduction more, the hinge lines of loose-leaf for example, as be formed on the hinge lines of the loose-leaf on framework 600 tops and/or the bottom.The line 600 of this strength reduction will make framework 600 more easily around axis A activity.
2. 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 among Figure 53 D and the 53D includes only a hole 615, this hole is used to receive the end of wearing the 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 do not allow with on adjusting nut pass through.In addition, different with the embodiment shown in Figure 53 A-C shown in Figure 53 E, this fin 620 does not comprise the hole.
Figure 53 F illustrates the framework 600 shown in Figure 53 D-E and is positioned at the operating position that is placed on patient's head model.Cushion C and ell have been contained on the framework 600.Figure 53 G is the sectional view of framework.
C. the framework that has sealing gasket
Figure 53 H illustrates another embodiment of the present invention, and in this embodiment, framework 640 is equipped with sealing gasket 645.The sealing pad extends along the bottom 650 of framework 640, and be configured in fastener 655 and at least a portion wear tool band 656 below, this part is worn each sidepiece 660 that the tool band is configured in 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, the sealing pad can be used gel and/or foamed materials manufacturing.
D. the framework that has peg
Figure 53 I illustrates first frame parts 661 and supports for example second frame parts 662 of cushion 663 of facial interface pieces.First frame parts 661 comprises main opening 664 and many first holes 665.Second frame parts 662 comprises many second holes 666 of aliging with the hole 665 of first frame parts 661.Second frame parts 662 comprises protuberance 667, and this protuberance is constructed to the main perforate 665 that can insert first frame parts 661.
Many pegs 668 are configured between first and second frame parts 661 and 662.Each peg 668 comprises first end 669 and second end 670.First end is inserted in first hole 665, and second end 670 is contained in 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 internal regulation of cushion 663.For example, the peg 668 that illustrates has all lengths, makes second end 670 can penetrate second hole 666, through the degree of depth specific to patient's facial appearance in the cushion 663.As shown in the figure, this peg is fixed by interference fit, can make framework 661,662 and/or cushion 643 fix in position, and perhaps peg 668 can comprise other structure, so that fixedly cushion or frame parts for example comprise barb or side groove.
E. inflatable cushion
Figure 53 J-53P illustrates embodiments of the invention, the cushion 172 that its middle frame 170 supportings are for example done 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 the figure is the single part that is embedded in the cushion 172, but this gas gallbladder can comprise the some separate parts that are positioned at the 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 for example communicates in air source or gel source etc. with substance source, thereby regulates the volume of gas gallbladder 173.Dispose this or each gas gallbladder, can reduce or reduce the distance between relevant cushion/frame part and the patient's face.For example, when Figure 53 L-53P was illustrated in framework 170 and is pressed in both sides, the distance of nasal bridge region diminished gradually.Figure 53 L-53P illustrates, and the variation of cushion both sides shape is asymmetric, though cushion and/or gas gallbladder 173 preferably change shape with symmetrical manner, this depends on that the appearance of patient's nose is that symmetry is asymmetric.
Also can form cushion 172 like this, make it when 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 thick relatively wall components of specification, makes can reduce the influence that relatively is not stressed and increases outer wall thus and increase the probability that ripple takes place with pressure.On the contrary, cushion inwall (near the wall of patient's nose) can be made of the wall components of specification relative thin, and this wall components can make these walls paste patient's nose bending, can strengthen sealing thus.
Cushion
According to the usage of this explanation, term " at the rear portion " is meant that with " rear portion " the cushion assembly is suitable for contacting that side of patient's face, and term " forwardly " is meant that with " front portion " the cushion assembly contacts that side of mask shell or main body.According to usage of the present invention, term " face shield " is meant the face shield of nose face shield and entire face.
Figure 54 A-54C is respectively that another known mask is promptly by Fisher ﹠amp; Paykel (F﹠amp; P) decomposing rearview, side view and the flat sheet of the bottom view of the ACLAIM nose face shield of Zhi Zaoing.This ACLAIM nose face shield comprises rigid frame or shell 50 and cushion assembly, and this assembly comprises thin silicon rubber membrane 10 and the foam gasket ring 30 that forms sealing.This shell 50 comprises the groove 51 that is formed by inwall 52.In use, these foam gasket ring 30 local configuration are in groove 51, and extension rearward (promptly near patient's face).Film 10 is fixed in the edge of shell 50 by tongue and groove mechanisms 60 (Figure 54 D).Foam gasket ring 30 plays the supporting member effect.
According to this cephalocaudal usage is described, term " ACLAIM cushion " is meant the cushion assembly shown in Figure 54 A-54D.
The cushion of some prior aries for example problem of ACLAIM cushion is that these cushions are collapsed under the high pressure effect easily, cause facial contact frame edge easily.This is uncomfortable to the 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 MIRAGE cushion.This film 110 and lower floor's cushion 120 are by 140 supportings of bottom cushion flange.This film 110 and lower floor's flange 120 can form 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 form parts separately, perhaps form single parts.Though it is not shown in the drawings, but cushion flange, film and lower floor's cushion are generally triangle, with bridge of the nose district, buccal region of face or labial region,superior (under the situation of nose face shield), perhaps the personnel selection face contour of wearing with chin district (situation of full-face face shield) formation is complementary.Shown in Figure 55, film 110 its shapes are general identical with lower floor cushion 120, and encirclement lower floor cushion 120.
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 for example is Durometer A hardness 20 or lower.This compliant member 130 can also be the thermoplasticity compliant member.
Figure 57 A-57C illustrates the mechanical property of cushion assembly 100 (Figure 57 A), and compares with the mechanical property of MIRAGE cushion (Figure 57 B) and ACLAIM cushion (Figure 57 C).The y axle is represented relative cushion height h/ho, and when cushion assembly 100 was positioned at its original height ho, this relative cushion height was 1.If cushion assembly 100 is compressed to its original height half, then the cushion height is 0.5 relatively.The x axle represents to act on the pressure F on the cushion assembly 100.This power F acts on to be used in making a concerted effort on the cushion assembly 100 between mask shell and the 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 in 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 illustrates the mechanical property of second embodiment of the invention cushion assembly 200, MIRAGE cushion and ACLAIM cushion respectively.Figure 60 D is illustrated in the comparison of three cushions in the coordinate system.The y axle is represented 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 the cushion assembly.
With reference to figure 60A, corresponding to the beginning zone of film 210, apply about 20% pressure of maximum, force mainly, the cushion height is reduced to about 95%.At the second area corresponding to cushion assembly 200 compliant members 230, when applying the pressure of about 60% maximum, force, compression is increased to 80% from 95%.In the 3rd zone of corresponding lower floor cushion 220, power is increased to 100% of maximum pressure, can only compress cushion assembly 200 a little.
Figure 60 B illustrates the mechanical property of MIRAGE cushion.The compression stress that applies about 50% maximum pressure in the zone corresponding to film can obtain about 75% compression, further increases compression stress and then only causes the cushion relative altitude to descend a little, the compression of this corresponding lower floor cushion.
Figure 60 C illustrates the mechanical property of ACLAIM cushion assembly, just can quite easily reach about 90% initial compression with less power.The further increase of pressure subsequently causes, and applies the very big compression that about 30% maximum pressure will cause the foam insert.When applied pressure is higher than about 30% maximum pressure, ACLAIM cushion assembly is only produced very little compression or even without any compression, because the foam insert is compressed on the mask shell fully.
Figure 60 B is illustrated in the comparison of three curves in front in the coordinate system.
Figure 61 is a sketch map, 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.Shown in Figure 61, compliant member 130,230 plays slinky spring, at the pressure that begins to absorb the 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 sealing thus, reduces or has eliminated gas leakage.
When the pressure on acting on cushion assembly 100 and 200 increases, more inflexible lower floor cushion 120,220 will begin compression.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 that stretches out from bottom cushion flange 340.Mask shell 350 is fixed in the rear end of bottom cushion flange 340.Configuration compliant member 330 between film 310 and bottom cushion flange 340.The compliant member 330 of this embodiment is generally high 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 by compliant member 330 supporting, this compliant member with pressure distribution on diverse location, thereby obtain more comfortable mask system.
Other diagrammatic sketch at compliant member 330 shown in Figure 63 A-63E.In this embodiment, compliant member 330 comprises a plurality of parts 331,332,334,335 of different qualities (stress and deformation characteristic).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 dimension, but has different spring constant (being rigidity), so that adapt to the difference of individual patient face size and shape.Should be noted that part 331,332,333 has different sizes, shape and spring constant with 334, so that adapt to the difference of facial size of individual patient and shape.Should also be noted that the part that can adopt any number.
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 of cushion flange 440.The front side of cushion flange 440 is fit to be connected in the shell of face shield.The second layer is made 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 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 of the silicone rubber top layer.Top layer 460 its thickness are preferably 0.2-0.6mm, this thickness or uniform, and perhaps according to load, perhaps the degree of deformation changes as requested.
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 of cushion flange 540.The front side of this cushion flange is fit to connect the shell of face shield.This cushion flange 540 comprises supporting part 545, and this supporting part stretches to rear side from the 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 the cushion shape, and forms the facial parts of contact.This compliant member 530 has the 3rd layer that is made of top layer 560.
Ground floor (cushion flange 540) is inflexible polyurethane rubber (non-foam).Second is made of urethane foam or soft silicone rubber.The 3rd layer (top layer 560) is made of the 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 the human face and exerted pressure in contact, just begin compression.When pressure increased, this compliant member 530 just further was compressed, until being crushed on fully on the supporting part 545.Further exert pressure and to 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 the 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 of the compliant member 630 that is connected in cushion flange 640.This compliant member 430 is determined the shape of cushion, and constitutes the facial parts of contact.
Ground floor (cushion flange 640) is inflexible polyurethane rubber (non-foam) layer.The second layer (compliant member 630) is made of foam, and comprises the relative higher second portion 632 with rigidity of rigidity relatively low first 631.Adopt the different densities foamed materials to form compliant member, can obtain different rigidity, as using shown in the point of relative spacing in first and second portion 631 and 632.Compliant member 630 is the single parts with different densities, or has some parts of different densities.Have two kinds of different rigidity (density) though in Figure 67, compliant member 630 is expressed as, will be appreciated that compliant member 630 can have two or more rigidity (density).Shown in Figure 67, second portion 632 comprises the regional 632a that extends through cushion flange 640, can prevent from thus to wear with the human face to be pressed on the cushion flange 640.
In use, when the first 631 of compliant member 630 wears with human face and Jia upward pressure in contact, just begin compression.When pressure increased, first 631 compressed fully, and second portion 632 begins compression simultaneously.Because second portion 632 is harder than first 631, so the reduction of relative altitude in second area 632 of the cushion assembly 600 that causes by exerting pressure is less than first area 631.
Though not shown in Figure 67, should see that 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 the framework 705.This framework comprises the hole 710 of passing cramp bar 715.This hole 710 and cramp bar 715 screw thread are each other twisted and to be closed, and make the position of bar 715 head part 720 to move, shown in double-head arrow.Shown in Figure 69, framework 705 has adjusting knob 725, thereby bar 715 is moved.Include only an adjusting rod 715 though framework 705 is shown on the figure, can dispose a plurality of such adjusting rods.In given pressure limit, the position of adjusting rod 715 can be so that the configuration of cushion changes.
Figure 70-the 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 change the amount of the cushion material above the spring members 730 according to the position of cushion with respect to patient's face.For example, at problematic or responsive sealing area, can be out of shape cushion, make spring members 730 deeper to be embedded in the cushion, can utilize cushion itself to reach and the sealing that problem or sensitizing range are arranged thus, and the effect of spring members, if any, neither be too big, an advantage is that spring members 730 is to embed fully, cannot see, so feel to seem simple, this may influence the compliance of patient treatment.
Figure 72 comprises the Flexible film made from the cushion 732 of foamed materials manufacturing and the most handy silicone rubber 734, and this film is configured on the inner surface of cushion 732.These Flexible film 734 easy applying patient faces.Figure 73 is a kind of device that has film 736 on supporting member 732 lateral surface.
Figure 74 is a kind of device, and cushion 732 has the groove 738 that is communicated with chamber 740 in this device, 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, the feasible stiffness characteristics that can change cushion.
Figure 75 A, 75B and 79 form the varying cross-section of at least two spring rates when being illustrated in the cushion compression.In Figure 77 and 78, cushion 732 comprises at least three kinds of spring rates between compression period, and cushion 732 comprises three layers of L1, L2 and L3 in Figure 77, and each layer has different spring rates.Figure 78 has first spring rate when being pressed into head part 747 in the groove 748, have second spring rate when core 749 being pressed in second groove 75, has the 3rd spring rate at 753 o'clock and divide bottom entering.
[00242] Figure 76 illustrates the cushion 732 with indenture 756, and this indenture helps by for example sealing between air-breathing maintenance cushion and the patient surface.
Advantage as the foam insert of compliant member is, foam is than the easier compression of silicone rubber, and therefore, the cushion assembly that comprises the foam insert of the present invention more uniform distribution is worn the active force of tool.
Advantages of silicon rubber as compliant member is, silicone rubber cleans easily, and with patient's bio-compatible more.It should be noted that, each parts in the above-described embodiments, promptly film, compliant member and cushion flange play a kind of mechanical spring.Can unite the foregoing description, for example the compliant member of first and second embodiment can have the different zone of a plurality of rigidity (density), and perhaps the various piece of the second embodiment compliant member can have the different zone of a plurality of rigidity (density).Adopt the multiple combined 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 the requirement effect.That this compliant member also can communicate with micropore density constant or that have a plurality of density or closed foamed materials manufacturing.This compliant member can be used, and also can cover without the top layer.
Can adopt the face shield tool of four bands, this face shield tool to be similar to the ULTRAMIRAGE that makes by Res Med Limited according to the face shield assembly that comprises the cushion assembly of one embodiment of the invention
TMThe face shield tool of mask system.
The face shield assembly that comprises the cushion assembly of the embodiment of the invention can adopt the U.S. Patent No. 6374826 described fasteners of wearing, 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 big belt tension of needs, this may be since active force by due to the uniform distribution.Compliant member also helps 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 manufacturing, low cost of manufacture.Cushion assembly of the present invention and prior art cushion for example ACLAIM cushion are compared not too complicatedly, and this ACLAIM is the cushion of three parts, need assemble before being fixed in face shield.
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 more reliable sealing.
An advantage more of the present invention is that the configuration compliant member can reach more stable sealing below film.This compliant member is owing to the motion that has reduced face shield, so the seepage velocity variations between face and cushion is also less.Like this, just, improved the treatment that the 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 crooked at the beginning, coupling face organ, but should not cause fully to be compressed, make that the end user's is uncomfortable because of the pressurization of cushion flange rigid element.
In more above-mentioned embodiment, cushion is configured on the framework with binding agent, and in another embodiment shown in Figure 80, this cushion is fixed on the framework with machanical fastener.In the example of Figure 80, face shield assembly 900 comprises main part 902 and the cushion 904 that is fixed on this main part 902, and this cushion 904 comprises the neoprene latex cushion 906 that covers with for example continuous silicone rubber membrane 908.Flexible portion 910 is because of above-mentioned reason, along the periphery configuration of main part 902.Main part 902 and film 908 are made of single part in this example.The periphery shoulder 914 on all shoulders 912 and connecting flexible framework 910 surfaces 916 in this film 908 comprises, this periphery shoulder 914 encases the edge of flexible frame 910.Perhaps, the periphery shoulder may be described as to comprise and admits flexible frame 910 outer peripheral grooves.Equally, interior all shoulders comprise the groove of admitting 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 in just no longer to be needed to use on the framework neoprene latex cushion is bonded on the framework, though 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 the nylon framework.
This face shield assembly is enough blocky, can bear the power that extreme condition applies, and therefore more reliable, the 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 the compliant member of the present invention.
Following tabular 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) |
| | 1.054(N/cm 2) |
| | 3.375(N/cm 2) |
| The sag coefficient | 3.20 |
| IHF | 4.36 |
| Return rate % | 57 |
Below definition obtain from existing open source literature, but above characteristic is shown its measurement unit of table be not the used measurement unit of above-mentioned definition.
Density is that unit volume is foamy heavy, is expressed as pound/foot below
3But go up the table density meter and be shown g/cm (pcF),
3The general density range of flexible polyethers urethane foam material is between 1-4pcf.This density is not that the tolerance and the latex rubber foam of hardness is different.For satisfying given load bearing requirement, the foamed materials of higher density generally has preferable quality and performance.
Pressure load deformation (CLD) (compression load defletion) also is a kind of tolerance of support load, generally is expressed as the pound/inch under certain percentage deformation condition
2(psi) in this test, the compression whole sample, the numerical value of mensuration and depth of foam are irrelevant, need only thickness not overlength degree and width.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 the heat ageing condition, the variation of load ability to bear.
The impression deformation (ILD) of load (indenation load deflection) is a kind of tolerance of load ability to bear, is expressed as pound load/50 inch under given foam percentage deformation condition
2In order to obtain this numerical value, 50 square inches plectanes (a) are pushed the top surface of foamed materials, under given deformed state, stop, and read load or scale.For example, 30 25%ILD means, need 30 pounds load 4 inches thick foam for panel could be compressed to 3 inches thick, load is big more, foamed materials is just hard more.In this test, the size of foam sample for the foamed materials of flat board, is generally 15 * 15 inches greater than the size of plectane.
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 the flexible foam specification are: USU (Urethane Slab Uncored); USC (UrethaneSlab Cored); UMU (Urethane Molded Uncored); UMC (Urethane MoldedCored).Numeric representation 25%ILD in this yard back, for example USU-30 be meant have a 25%ILD of 30 be not in the mood for the plate foam material, when measured value is subjected to the foamed materials original thickness and influences, the original thickness of foamed materials must be shown.(seeing BASF Wyandotte TechnicalAdvisory, " Effect of Foam Thickness on ILD " .)
The sag coefficient is 65%ILD and the ratio of 25%ILD, expression cushion quality.High numeric representation touches the resistance at the end.Foamed materials common " touching the end " with 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 coefficient is determined 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.
When measuring ILD, read in 25% displacement, 65% deformation usually and after removing load, get back to the numerical value of 25% deformation again.Getting back to this 25% deformation values with beginning 25% deformation values when removing load is recovery rate, is expressed as %.For making liner usefulness, the recovery rate of having relatively high expectations is used to absorb vibration and then requires the low recovery rate in the end.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.The normal loading is 25 pounds, 50 pounds or 75 pounds.The IRGL value is represented with inch.Must know the original thickness of foamed materials, so that the value that obtains is meaningful.This tolerance is through being usually used in illustrating automobile foamed materials specification.Between ILD and IRGL measured value, there is not ready-made dependency relation.
Guide factor is 25%ILD and the ratio of density, and this term is used for determining the relative hardness of different densities foamed materials.Density is approaching more, good more comparison.When density not simultaneously, the foamed materials with the highest Guide factor has the cost advantage.But performance differs and reserves.Another term of Gride factor is normalized ILD.
Impression modulus (IM) is in the ILD of 20%ILD and 40% scope, produces the required load of 1% impression.This collinear slope depends on the resistant to bending ability of microcellular foam wall.
Resilience is a kind of tolerance of foamed materials elasticity or elastic force.In this test, steel ball is dropped on the foamed materials, and bounce-back is expressed as the percentage resilience, the same with response rate, the value of requirement depends on application.For very soft foamed materials resilience the people is misread, because under the effect of ball, foamed materials will touch the end.Like this, even foamed materials is " flexibly " or elastic, but also obtain very low resilience value.The ball bounce-back is another term of this characteristic.
Tensile strength is that foamed materials is being stretched and a kind of 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 when measuring tensile strength.Extensibility be can tensile elongation before foamed materials fracture tolerance, be expressed as the percent of original length.
Tear strength is a kind of after foamed materials has begun to split or disconnected, and continues to tear a kind of tolerance of the required power of this foamed materials, is expressed as pound/linear inch (pli, perhaps more common is 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, keeps after the foam compresses tolerance of foamed materials deformation.Standard conditions are under 158 conditions 22 hours.In this test, foam compresses to given thickness, is expressed as the percent of its original thickness.The most common percent that is expressed as initial compression of compressive deformation.
Fatigue is a kind of a kind of tolerance of load ability to bear loss under service-simulated conditions, generally is expressed as the percentage rate load loss.Two prevailing testing fatigues are static fatigue test and pressure roller shear fatigue test (roller shear fatinue).
In the static fatigue test, foamed materials at room temperature is compressed to 25% of its original thickness, compress 17 hours, will calculate the 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 moving than foamed materials width.This roller is contained in transversely movable position, so that apply shear force.When using constant deformation setting value or constant pressure roller weight, the method for testing difference according to the explanation of method of testing, is calculated the loss amount of ILD or IRGL.
Air mass flow is a kind of tolerance of foamed materials porosity or unlimited degree, is expressed as cubic foot of air/min (cfm).Explanation according to the ASTM method, utilize vacuum that air was taken out foamed materials, the perhaps explanation of reporting according to BASF Wyandotte Technical Advisories, use device, promptly " BWC portable air flow measurement device " and " BWC portable air flow measurement improved device " makes the blows air over foamed materials.
Also have many other foamed materials characteristic and method of testings.Wherein manyly find out the special aspects that is used to consider.Among the standard method D-1564 and D-2406 in the special foamed materials specification part of ASTM, can find other the term definition and the explanation of method of testing.
Although the present invention according to now the most suitable preferred embodiment explanation the present invention, should be understood that to the invention is not restricted to disclosed embodiment, on the contrary, present invention resides in various modification and equivalent device in the spirit and scope of the invention.
Claims (33)
1. the face shield assembly of a malleation feeder comprises:
The mask body assembly is constructed with being configured to and can be sealed at least a portion that contacts patient's face, thereby the breathing gas of pressurization is provided for the patient;
Mask frame is connected in the face shield cushion, and this mask frame has one or more receiving-members, is used for the bound fraction of receiving belt fixed mechanism;
Wear assembly, comprising:
One or more bands, each in these one or more bands has the band fixed mechanism, and the receiving-member of mask frame is constructed and be configured to engage to this fixing machine;
Tension part is connected in one or more bands flexibly, so that according to the breathing gas pressure of supplying with the patient, regulates the tension force of these one or more bands automatically.
2. face shield assembly as claimed in claim 1 is characterized in that, these one or more bands are non-retractable basically.
3. as each described face shield assembly in claim 1 and 2, it is characterized in that, this flexibly tension part be inflatable gas gallbladder, for example occipital bone air cushion or gas bag, this gas gallbladder is connected in this one or more bands.
4. face shield assembly as claimed in claim 3 is characterized in that, this inflatable gas gallbladder can utilize the part inflation of the pressure breathing gas that is transported to face shield assembly.
5. as each described face shield assembly in claim 3 and 4, it is characterized in that when the breathing gas pressure that flows to the patient increased, the pressure in the inflatable gas gallbladder increased.
6. as each described face shield assembly among the claim 3-5, it is characterized in that also comprise the conduit with two ends, first end is fit to be connected in the breathing gas conduit, second end is fit to be connected in inflatable gas gallbladder, thereby forms gas communication with the breathing gas conduit.
One kind in Noninvasive malleation air-supply mask control belt tension method:
Tension element flexibly is connected in the band of face shield;
When the breathing gas pressure that is transported to the patient increases, this flexibly tension part automatically increase the tension force of band.
8. method as claimed in claim 7 is characterized in that, tension part is inflatable gas gallbladder, for example occipital bone air cushion or gas bag flexibly.
9. method as claimed in claim 8 is characterized in that, when the method that makes flexible tension part increase belt tension automatically is included in the breathing gas pressure increase that is transported to the patient, and the gas gallbladder of automatic inflating inflatable.
10. non-retractable basically assembly of wearing constructs and is configured to be connected in the face shield of malleation feeder, and this is worn tool and comprises:
One or more non-retractable basically bands;
Inflatable gas gallbladder, for example occipital bone air cushion or gas bag, this gas gallbladder and one or more band formation power transmission relation.
11. the face shield assembly of a Noninvasive malleation feeder comprises:
Mask frame has the inflexible basically side part that is connected with soft top by soft bottom;
The mask body assembly is connected in mask frame, and can move with respect to this framework;
Wear tool, construct and be configured to be connected in mask frame with unclamping, this is worn tool and comprises the flexible tension part that forms the power transmission relation with framework, and this flexible tension part is constructed to and is suitable for when using face shield assembly, freely moves to regulate and wears tool tension force.
12. aspect as claimed in claim 11 shade assembly is characterized in that, this flexible tension part is inflatable gas gallbladder, for example occipital bone air cushion or gas bag.
13. a face shield assembly that is used for Noninvasive malleation feeder is suitable for being placed on patient's the face, comprising:
Mask frame has by soft bottom and divides the inflexible basically side part that is connected with item parts, and definite longitudinal axis is divided in this top portion and bottom;
The mask body assembly is connected in mask frame;
The face shield cushion is connected in mask body;
Wear tool, comprise at least one band, this band constructs and is configured in use to locate along the side of head;
Wherein this mask frame can be around this longitudinal axis generation elastic deformation around patient's face, thus configuration that can adaptive patient's face, and be fixed at least one band.
14. a method that remains on patient's face comprises with making mask seal:
The occipital bone air cushion is placed on the part of head and/or cervical region;
Make band cross this air cushion, this band reaches the place ahead, is connected in face shield;
Use pressure P
BladderInflate this air cushion, this pressure is mask pressure P
MaskAffine function:
P
bladder＝P
0+A
maskP
mask
P in the formula
0Be malleation, this pressure to when minimum working pressure, is enough to make face shield to reach sealing, A greatly
MaskBe between air cushion and the band between the contact area at rear portion and air cushion and back of head less contact area in the fore contact area.
15. method as claimed in claim 14 is characterized in that, uses the pressure inflatable air cushion, this pressure is the affine function of mask pressure, and this method may further comprise the steps:
Measure mask pressure with pressure transducer, produce the signal that is proportional to mask pressure thus;
This signal is added on gain and the deviation adjustable amplifier;
The output of amplifier is added on the pressure source of voltage controlled;
With the above-mentioned air cushion of gas inflated in the above-mentioned pressure source;
Regulate above-mentioned deviation, make cushion under the pressure of subsistence level, can reach sealing;
Regulate above-mentioned gain, make face shield to be issued to sealing at the pressure of high needs.
16., it is characterized in that, if the signal V of pressure transducer as each described method in claim 14 and 15
PtBe V
Pt=K
PtP
Mask, then the controllable pressure source produces pressure P
c=K
cV
c, face shield and facial contact area in the wings to projected area be A
Mask, the band with air cushion rear surface contact area forwardly to projected area be A
Bladder, reaching the needed power of sealing when pressure is zero is F
0, then amplifier produces output voltage:
V
out＝F
0/A
bladder+A
mask/A
bladderK
c/K
ptV
in
17., it is characterized in that with this air cushion of pressure inflatable, this pressure is the affine function of mask pressure as each described method among the claim 14-16, this method may further comprise the steps:
Face shield is connected in first cylinder that comprises first piston by first flexible pipe, above-mentioned first piston is connected in second piston in second cylinder by connecting rod again, above-mentioned second cylinder is hose connection in above-mentioned air cushion by second, the above-mentioned connecting rod of bias voltage, above-mentioned air cushion is fully inflated, thereby made face shield under minimum predetermined working pressure, can reach sealing.
18. a device that remains on patient's face comprises with making mask seal:
First group of tensile band, rear portion from the beginning reaches face shield forward, with the tensioning fully of above-mentioned band, make above-mentioned face shield minimum working pressure lower seal remain on the face;
Second group of flexible band, still rear portion from the beginning reaches face shield forward, this second group of band be positioned at first group of band above;
Inflatable occipital bone air cushion is placed on the rear portion of head, and between above-mentioned first group of band and second group of band, above-mentioned air cushion communicates with air fluid in the face shield.
19. one kind is added in patient's face shield assembly on one's body with Noninvasive malleation feeder, comprising:
Framework comprises main body, and this main body comprises at least one hole, and the shape in this hole is constructed to the pressurized breathable gas that can receive conveying, and said frame comprises that at least one is contained in the part of selecting on the main body, and the above-mentioned part of selecting is adjustable with respect to main body;
Cushion is contained on the framework, and this cushion is constructed to the interface that forms with the patient, and when applying malleation, above-mentioned cushion acts on a kind of power to the patient, and this power can be according to 1) in this frame part of selecting of set-point of above-mentioned malleation position with respect to main body; And/or 2) variation of this malleation is regulated.
20. face shield assembly as claimed in claim 19, it is characterized in that, comprising also that at least one is configured in wears the tool coupling part on the frame part, the said frame part can be carried out activity according to wearing the variation of tool belt tension, thereby in use, can regulating action in the power of patient's nose and/or facial both sides.
21. face shield assembly as claimed in claim 19 is characterized in that, this framework comprises governor motion, and this governor motion comprises at least one preferably many isolated adjusting knob, and this adjusting knob can be regulated and change relative position between main body and the frame part.
22. face shield assembly as claimed in claim 19 is characterized in that, this frame part of selecting comprises the compliant member that supports cushion.
23. face shield assembly as claimed in claim 19 is characterized in that, this main body and the frame part of selecting are formed interconnective two separate parts.
24. face shield assembly as claimed in claim 19 is characterized in that, utilizes cam mechanism that this main body is moved with selecting partly.
25. face shield assembly as claimed in claim 19 is characterized in that, cushion comprises at least one wherein inflatable parts, thus the effective rigidity of scalable and/or cooperate with the effective of patient.
26. face shield assembly as claimed in claim 25 is characterized in that, this can fill institute's parts and be configured to alternative size of regulating the cushion nasal bridge region.
27. face shield assembly as claimed in claim 19 is characterized in that, this frame part of selecting comprises each frame facet part with the flexible material manufacturing of framework.
28. face shield assembly as claimed in claim 19 is characterized in that, this cushion comprises at least one parts, and these parts can provide cushion a plurality of stiffness coefficients when active force changes.
30. a face shield cushion assembly that is used to handle the irregular breathing of sleep, this cushion assembly comprises:
The cushion flange that suitable rigid material is done, this cushion flange comprise and are fit to be connected in first side of mask body and face toward the first lateral trailing flank;
Lower floor's cushion is connected in the cushion flange, and stretches to rear side, and this lower floor's cushion has first rigidity;
Film, be connected in the cushion flange, and stretch to rear side, this film has the shape of mating lower floor's cushion shape substantially, and surrounds lower floor's cushion, and this film has second rigidity, this rigidity is less than first rigidity, this film is suitable for pasting the face of wearing personnel selection, and when pasting, at face shield with wear with forming sealing between the human face;
Compliant member is configured between lower floor's pad and the film, and this compliant member has at least the three rigidity, and this rigidity is greater than second rigidity, and less than first rigidity.
31. cushion assembly as claimed in claim 30 is characterized in that this compliant member is formed by a plurality of parts.
32. as each described cushion assembly in claim 30 and 31, it is characterized in that this compliant member is to be made of foamed materials, this compliant member is made of silicone rubber.
33. a face shield component software that is used to handle the irregular breathing of sleep, this cushion assembly comprises:
By the cushion flange of suitable rigid material, this cushion flange comprises and is fit to be connected in first side of face shield assembly main body and faces toward the first lateral trailing flank;
Film is connected in the cushion flange, and stretches to rear side, and this film has first rigidity, and this film is suitable for contacting patient's face, and in when contact, at face shield with wear with forming sealing between the human face;
Compliant member is configured between film and the cushion flange, and this compliant member has at least second rigidity greater than first rigidity;
Retainer contacts the compliant member of its supporting, and this compliant member is configured between cushion flange and the retainer.
34. a face shield cushion assembly that is used to handle the irregular breathing of sleep, this cushion comprises:
Ground floor comprises being suitable for being connected in the leading flank of cushion main body and facing toward the first lateral trailing flank;
The second layer is connected in ground floor, and stretches to trailing flank from the leading flank of ground floor, this second layer is determined the cushion shape, and is suitable for contacting the face of wearing personnel selection, and when contact, at face shield with wear with forming sealing between the human face, and when the cushion assembly is afterburning, be compressed.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US42400502P | 2002-11-06 | 2002-11-06 | |
| US60/424,005 | 2002-11-06 | ||
| US60/447,327 | 2003-02-14 | ||
| US60/488,752 | 2003-07-22 | ||
| US60/503,896 | 2003-09-22 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200910135465.7A Division CN101574553B (en) | 2002-11-06 | 2003-11-06 | Mask and components thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1735439A true CN1735439A (en) | 2006-02-15 |
| CN100502972C CN100502972C (en) | 2009-06-24 |
Family
ID=36077487
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200910135465.7A Expired - Fee Related CN101574553B (en) | 2002-11-06 | 2003-11-06 | Mask and components thereof |
| CNB2003801083961A Expired - Fee Related CN100502972C (en) | 2002-11-06 | 2003-11-06 | Mask and components thereof |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200910135465.7A Expired - Fee Related CN101574553B (en) | 2002-11-06 | 2003-11-06 | Mask and components thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (2) | CN101574553B (en) |
Cited By (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2219719A1 (en) * | 2007-11-15 | 2010-08-25 | ResMed Ltd. | A cushioning structure |
| CN102245250A (en) * | 2008-12-10 | 2011-11-16 | 雷斯梅德有限公司 | Headgear for masks |
| CN101489618B (en) * | 2006-07-18 | 2012-03-21 | 帝人制药株式会社 | Respiring nose mask system |
| CN101437565B (en) * | 2006-05-04 | 2012-11-28 | 南方医疗器材设备公司 | Patient oxygen delivery mask |
| US8485192B2 (en) | 2005-01-12 | 2013-07-16 | Resmed Limited | Cushion for patient interface |
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| CN2056858U (en) * | 1989-05-06 | 1990-05-09 | 广东省新技术进出口公司 | Once-used air-cushion mask for aneathesia and oxygen therapy |
| EP1118346A3 (en) * | 2000-01-21 | 2003-06-18 | MPV-Truma Gesellschaft Für Medizintechnische Produkte mbH | Nasal breathing mask and mask cushion for a nasal breathing mask |
| US20030154978A1 (en) * | 2000-06-14 | 2003-08-21 | Gradon Lewis George | Breathing assistance apparatus |
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Also Published As
| Publication number | Publication date |
|---|---|
| CN100502972C (en) | 2009-06-24 |
| CN101574553B (en) | 2014-06-04 |
| CN101574553A (en) | 2009-11-11 |
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