CN100577232C - Mask system - Google Patents

Abstract

A mask system includes a frame, cushion, cushion clip, swivel elbow, headgear and/or headgear clips that are configured for use in a clinical or hospital environment. One or more components of the mask system are configured to promote single patient use, e.g., by providing an age indicator and/or preventing disassembly and/or cleaning, etc.

Description

Mask system

The cross reference of priority application

It number is 60/533 that the application asks for protection U.S. Provisional Application that December in 2003 submitted on the 31st; 229, the application number of submitting on May 17th, 2004 is 60/571; 488, the application number of submitting on July 16th, 2004 is 60/588; please number be 60/619 in submitting on October 18th, 341 and 2004; 022 interests are incorporated it at this as quoting all.

Technical field

The present invention relates to be used for the patient as adult patients, disposable mask system, it is used for the treatment of obstructive sleep apnea (OSA:obstructive sleep apnea), or be used for by using continuous positive airway pressure (CPAP:continuous positive airway pressure), twin-stage, or other pressure support ventilalions, non-infringement positive airway pressure (NIPPV:non-invasive positive pressure ventilation) support is provided.Described face shield is used for single patient and short-term is used, and described short-term has the useful life as 7-14 days.Preferably, this face shield only can use 7 days.

Background technology

Leiximadd Co., Ltd Disposable full face mask is made of the framework with double-walled silicones cushion.Cushion, ell and/or blow vent parts can be pulled down from framework.Though this face shield has stronger sealing and comfortableness, it does not demonstrate the characteristic that is suitable for hospital and clinical use most, and they are different with the characteristic that is suitable for most domestic or other uses.

Another prior art be Leiximadd Co., Ltd disposable nasal mask (ResMed ' sDisposable Nasal

), this face shield has PVC airfoam cushion and styrene framework.Reflection 3 disposable full face masks (Image3 Disposable FullFace Mask) from Respironics have framework and silicones cushion.It is the disposable full face mask of Respironics frequency spectrum (Spectrum Disposable Full Face Mask) with independent PVC cushion and framework that the disposable face shield of a kind of all cover is arranged again.The disposable full face mask of prunus mume (sieb.) sieb.et zucc. moral 2100 sequences (Med Series 2100 Disposable Full Face Mask) has PVC framework and airfoam cushion.Also having a kind of face shield is " Performa Trak ", is the full face mask from the single use of Respironics.

The face shield of above-mentioned prior art is not provided at the suitable fully and/or best solution of using mask system in hospital or the clinical setting.For example, these face shields show the relevant character of one or more and reusable face shield typical case.Therefore, these face shields may produce dangerous mode to the patient and unexpectedly reused with a kind of, and described danger is as the danger of diffusion antibacterial etc.

Summary of the invention

One of the present invention is characterised in that a kind of mask system is provided that it can partly overcome prior art problems at least.

Of the present invention another is characterised in that provides a kind of disposable face guard, and it has the useful life, promptly can be use separately or one short for example 7-10 days or use in time limits of many today again.Preferably, face shield only can use 7 days.

Of the present invention another is characterised in that provides a kind of face shield, it has the indication of for example visual indication, with represent this face shield be used once, more than once or surpassed the number of times or the time limit of recommending.

Therefore of the present invention another is characterised in that provides a kind of face shield assembly, and it is difficult to dismounting under situation about not damaging, and has removed various use and has stoped pulling down as the safety component of the anti-valve that suffocates.

Of the present invention another is characterised in that provides a kind of face shield, and it is the needs of disposable and/or satisfied usually different with the demand of use face shield in the home environment clinical and hospital environment.

On the other hand, face shield is designed to be adjusted by clinician and nurse.

Of the present invention another is characterised in that provides a kind of face shield cheaply, and this face shield has embodied the huge difference between the disposable and reusable product on function items, aesthetic and/or durability.

These and other feature of the present invention will represent in the description of following preferred embodiment.

Description of drawings

The axonometric chart of Fig. 1 for watching from the left front set forth first preferred embodiment of the present invention;

Fig. 2 is a rearview of the present invention;

Fig. 3 looks three-dimensional exploded view for the master of part assembly shown in Figure 1;

Fig. 4 is the rear perspective exploded view of part assembly shown in Figure 1;

Fig. 5 is the upward view of face shield assembly shown in Figure 1;

Fig. 6 is the vertical view of face shield assembly shown in Figure 1;

Fig. 7 is the right view of face shield assembly shown in Figure 1;

Fig. 8 is the axonometric chart according to the framework of the embodiment of the invention;

Fig. 9 is the rearview according to the framework of the embodiment of the invention;

Figure 10 is the vertical view according to the framework of the embodiment of the invention;

Figure 11 is the upward view according to the framework of the embodiment of the invention;

Figure 12 is the side view according to the framework of the embodiment of the invention;

Figure 12 A is the axonometric chart of framework according to another embodiment of the present invention;

Figure 13 is the main parallax stereogram according to cushion of the present invention;

Figure 14 is the front view according to cushion of the present invention;

Figure 15 is the rearview according to cushion of the present invention;

Figure 16 is the rear perspective view according to cushion folder of the present invention;

Figure 17 is the side view according to cushion folder of the present invention;

Figure 18 is the part sectioned view of the decomposition of display frame, cushion and cushion clip assembly;

Figure 19 is the part sectioned view of the assembling of display frame, cushion and cushion clip assembly;

Figure 20 is the part section axonometric chart of the decomposition of assembly shown in Figure 180;

Figure 21 is the exploded perspective view according to rotation ell of the present invention;

Figure 22 is the assembly drawing according to rotation ell of the present invention;

Figure 23 is the profile according to rotation ell of the present invention;

Figure 23 A is the local detail enlarged drawing of Figure 23.

Figure 23 B is the solid and the profile of ell according to an embodiment of the invention;

Figure 24 is for rotating the rear perspective view of ell according to an embodiment of the invention;

Figure 25 is for rotating the main parallax stereogram of ell according to an embodiment of the invention;

Figure 26 is for rotating the rearview of ell according to an embodiment of the invention;

Figure 27 is for rotating the upward view of ell according to an embodiment of the invention;

Figure 28 is for rotating the side view of ell according to an embodiment of the invention;

Figure 28 A is the axonometric chart of rotation ell according to another embodiment of the present invention;

Figure 28 A-1 and Figure 28 A-2 are the accompanying drawing of ell according to still another embodiment of the invention;

Figure 28 B and Figure 28 C are the accompanying drawing according to the ell of an alternate embodiment of the present invention;

Figure 28 D to Figure 28 H is according to the accompanying drawing of the ell of an embodiment more of the present invention;

Figure 29 is according to the membranous main parallax stereogram of the anti-valve that suffocates of the present invention;

Figure 30 is according to the membranous front view of the anti-valve that suffocates of the present invention;

Figure 31 is according to the membranous side view of the anti-valve that suffocates of the present invention;

Figure 31-A to Figure 31-I has described with the corresponding to face shield assembly of embodiments of the invention, time and has managed, rotates and/or the anti-valve barrier film that suffocates.

Figure 32 is the front view according to head-shield folder of the present invention;

Figure 33 is the axonometric chart according to head-shield folder of the present invention;

Figure 34 is according to the rearview of head-shield folder of the present invention;

Figure 34 A and Figure 34 B are that the master of head-shield folder according to another embodiment of the present invention looks and rear perspective view;

Figure 35 is the axonometric chart of headband according to an embodiment of the invention;

Figure 36 is the main parallax stereogram that is positioned at the headband shown in Figure 35 on patient's head;

Figure 37 is the rear perspective view that is positioned at the headband shown in Figure 35 on patient's head;

Figure 38 has described the another embodiment according to headband of the present invention;

Figure 39 is the main parallax stereogram that is positioned at the headband shown in Figure 38 on patient's head;

Figure 40 is the rear perspective view that is positioned at the headband shown in Figure 38 on patient's head;

Figure 41 is according to the axonometric chart of the headband of an embodiment more of the present invention; With

Figure 42 is the axonometric chart that is positioned at the headband shown in Figure 41 on the model patient head.

The specific embodiment

Below, will be described the preferred embodiments of the present invention in conjunction with the accompanying drawings, wherein, identical label symbol is represented same parts.

Fig. 1 has represented face shield assembly 10, and it comprises: the framework 12 of shell form and be attached to cushion 14 on the framework 12.Rotation ell 16 rotatably connects or is arranged at framework 12.As be known in the art, described rotation ell 16 comprises the air inlet pipe 18 of reception from the pressurized breathable gas of suitable pressurized-gas source.Rotation ell 16 comprises one or more holes 20, and this hole is used for discharging continuously the CO that discharges from the respiratory cavity that is formed by framework 12 and cushion 14 ₂ Gas.Framework 12 comprises at least one pair of sidepiece outrigger 22, and its support is used for receiving with headband (for example, sees that the continuous adapter folder of Figure 35-Figure 40) (for example, sees the adapter folder socket 24 of Figure 32-Figure 34).Framework 12 comprises the top extension 38 that is positioned at the middle part, and this top extension 38 includes and is used for and the mutual banded multiple structure of a head-shield band of head-shield (headgear).

Framework 12 also comprises at least one port 26, is used to introduce the pressure monitoring detector, or is used for for example oxygen (O ₂) the pure gas inside (passing through pipe fitting) of introducing respiratory cavity.Described port 26 can suitably be covered by port cap 28, and in Fig. 1, port cap 28 is positioned at disjunct position.As described below and shown in, port cap 28 can be formed an integrated part as cushion 14.

Fig. 2 is the patient's side view or the rearview of face shield assembly 10.The facial contact of cushion 14 partly preferably includes as the U.S. Patent number that has transferred Leiximadd Co., Ltd and is 6,513,526 described bilayers, the structure of spaced walls is arranged, and at this it is incorporated into as quoting all.Yet, under the situation that does not exceed technological thought of the present invention and scope, also can use other soft cushion structures, as monolayer or three layers of soft cushion structure.In addition, cushion can be made of silicones, foamed materials, gelinite etc. or its compositions.

Fig. 2 has also described the hole 30 that is communicated with respiratory cavity of air inlet pipe 18 that makes rotation ell 16.The 30 basic supports 32 that have on every side as the part of framework 12 in the hole for circle.Support 32 is formed with and is used for the anti-valve barrier film 34 that suffocates and (sees the surface of Figure 29-Figure 31) for details.As described below in more detail, the anti-valve barrier film 34 that suffocates is between support 32 and rotation ell 16.

The master that Fig. 3 and Fig. 4 have described face shield assembly 10 as shown in Figure 1 looks the exploded view with backsight, and wherein not conforming to has rotation ell 16 or the relevant anti-valve barrier film 34 that suffocates.As shown in Figure 3, the anti-valve barrier film 34 that suffocates is located in the position on the circular support surface 36 of contiguous framework 12.

Framework 12 comprises at least one and preferably comprises a plurality of through holes 40 that this through hole 40 is used for aiming at the respective through hole 42 on the cushion 14.Cushion 14 is sandwiched between framework 12 and the cushion folder 44.Cushion folder 44 comprises the fastener or the bar 46 of respective amount, and it for example is that flanged peripheral part 48 along cushion folder 44 is arranged.Through hole 42 and 40 are aimed at and passed respectively to described bar 46 with the through hole 42 and 40 of cushion 14 and framework 12.The tip of bar 46 can be a snap fit, hot melt or ultrasound wave distortion, thereby interfix with respect to through hole 40, therefore clamp cushion 14 in framework 12 and the appropriate location that cushion presss from both sides between 44 effectively.Bar 46 can have the enlarged head of taper to pass through hole 40,42, realizes the purpose of assembling.But the head of expansion has stoped the dismounting of framework, cushion folder and cushion.So cushion can for good and all be clipped in described position, just be difficult to dismounting, this point may be beneficial in hospital or clinical setting.Yet if desired, cushion can be configured to allow the structure of selectable dismounting.Cushion 14 comprises sidepiece periphery flange 50, and it also can be sandwiched or be clamped between framework 12 and the cushion folder 44.Fig. 3 has shown that also flange 50 can have by bridge 29 and the port cap 28 whole stayed surfaces that are connected.Optionally, framework can have bar, and the cushion folder can have through hole.

Fig. 4 has represented the inner surface 52 of framework 12 best.What be adjacent to inner surface 52 is axial wall components 54, and it preferably extends to form the opening of framework 12 along overall circumference.Wall 54 is provided for the support of the medial wall of the sidewall of cushion 14 and cushion folder 44.Fig. 5-Fig. 7 is the further assembly drawing of framework 12, cushion 14 and rotation ell 16.

Fig. 8-Figure 12 is the accompanying drawing of further independent describing framework 12.Shown among Fig. 8 that framework 12 comprises recess 56, recess 56 is used to make bridge 29 (seeing Fig. 3, Figure 14 and Figure 15) to pass through to framework one side from cushion one side.Framework 12 also comprises a plurality of outthrust or castellated projection 60, to realize the purpose of the maintenance of the anti-valve barrier film 34 that suffocates in the auxiliary elbow assembly (seeing Figure 22, Figure 23 and Figure 29).As shown in figure 12, framework 12 comprises the periphery flange 64 that forms groove 66, and rotation ell 16 is fixed on the framework 12 by this groove 66.

Fig. 8 has described outrigger 22 and has comprised supporting leg 68, and each supporting leg all has: be connected to or be arranged at first end on the main part of framework 12 and be connected to or be arranged at second end on the adapter folder socket 24.Preferably, outrigger forms the integral body that comprises framework 12 and outrigger 24.And, as Fig. 8 and shown in Figure 9, outrigger 22, for example supporting leg 68 can center on axis 72 bendings and/or warpage.Supporting leg 68 also can be set to the structure that the mode of hinge-like is rotated.This rotation be provided with certain benefit, for example, the head-shield band tightens automatically and/or the time limit/use indication, below more completely illustrates.Figure 10-Figure 12 has represented vertical view, upward view and the side view of framework 12 respectively.Have four-headed arrow among Figure 10 and Figure 11, schematically represent bending, rotation and/or the warpage of supporting leg 68 around axis 72.

Figure 12 A be framework 12 ' the axonometric chart of optional embodiment.Framework and the framework shown in Fig. 8 among Figure 12 A are closely similar, and its only main difference is, framework 12 ' comprise 16 castellated projectioies 60, rather than 8.The quantity increase of castellated projection helps to reduce in ell and the anti-leakage that suffocates between the valve barrier film.But the quantity of castellated projection can change, and for example can comprise any quantity of 16 of being higher or lower than.

In another embodiment, the one or both ends of supporting leg 68 can comprise a part 70, and upper-arm circumference can rotate around this part 70, bending and/or warpage.This will make face shield take various structures, and for example, as the schematic indication of arrow among Fig. 9, the main body by relative framework vertically upward or move down outrigger.Preferably, supporting leg 68 can be parallel to each other to adapt to above-mentioned adjustment, even in supporting leg shown in Fig. 8 and Fig. 9 and not parallel (promptly being trapezoidal).

Figure 13 to Figure 15 has represented the various accompanying drawings of cushion 14 individually; And Figure 16 and Figure 17 have represented the various accompanying drawings of cushion folder 44 individually.

Figure 18 is part section and exploded view, presss from both sides 44 being connected to highlight framework 12, cushion 14 and cushion.Figure 19 is the assembly drawing of the described parts of Figure 18; And Figure 20 is the axonometric chart of exploded view shown in Figure 180.To shown in Figure 20, framework 12 comprises the parts 13 of pearl as Figure 18, and it helps to be provided with and guarantees positiver sealing between framework 12 and cushion 14.Figure 19 has shown the pearl parts 13 that are embedded into cushion 14, although cushion 14 also can comprise groove or the hole that is used to hold pearl parts 13.Pearl parts 13 can be seen in Fig. 4.

Figure 21 comprises rotation ell 16, anti-valve barrier film 34 and the swivel joint 76 of suffocating for the exploded view of rotation ell assembly 73, rotation ell assembly 73.Swivel joint 76 comprises first end 78 that is connected with air inlet pipe 18 and second end 80 that is connected with the gas delivery tube that is connected to the pressurized breathable gas source.

Figure 22 is the assembly drawing of parts shown in Figure 21; And Figure 23 is the profile of the rotation ell assembly of assembling.As shown in figure 23, the anti-valve barrier film 34 that suffocates is preferably made by elastomeric material.Rotation ell 16 comprises the basic pipe 82 in columniform that is.As direction arrow indication among Figure 23, cylindrical tube 82 can enter gas and discharge between the gas baffle plate is set what send into by swivel joint 76.Figure 23 A has represented the detailed enlarged drawing of the part assembly shown in Figure 23; And Figure 23 B is the part sectioned view that is connected in the ell of the framework that in position has parts 34.

The anti-valve barrier film 34 that suffocates comprises main body 84, and it is by friction, with the upright wall member sealing and/or the interlocking that form as rotation ell 16 parts.The anti-valve barrier film 34 that suffocates also comprises hole 88 (Figure 21), and it comprises inner circular bead 90, and the outer surface that this inner circular bead 90 is used to be against the cylindrical tube 82 of rotation ell 6 seals (Figure 23).The anti-valve barrier film 34 that suffocates comprises outside shoulder 94, and it is dark that it prevents that barrier film 34 from embedding in the ell 16 in rotation, and allows and rotate being slidingly matched of upright wall member 86 of ell 16.

Figure 24 is the axonometric chart of the rotation ell 16 watched from patient's one side.Gas is imported into the dome portion 98 of rotation ell 16 by air inlet pipe 18.The rotation ell comprises that a plurality of friction reinforcing members 100 keep and the friction engagement of rotating ell 16 to guarantee the anti-valve barrier film 34 that suffocates.

As Figure 24 and shown in Figure 25, rotation ell 16 also comprises a plurality of slits or hole 102, is provided with a plurality of protruding parts 104 in its vicinity.Protruding part 104 (Figure 24) for tilting, thus, when the flange 64 that meshes as shown in figure 12, slight expansion just takes place or outwards protrudes (cam-out) in protruding part, up to crossing flange 64 and making protruding part 104 be placed in groove or the otch 66, at that point, each parts snap fit is to connect.Being provided with of hole 102 helps rotate ell 16 and dies down, thereby in case attempt the rotation ell is pulled down from face shield, the part of support protrusion parts or protruding part self can be out of shape so, and/or disengaging rotation ell 16, therefore abandon out of use face shield, in this case, the face shield that need more renew for the patient.Yet, optionally weaken and can not cause adverse influence the performance of face shield.When the anti-valve part that suffocates was inoperative, the effect that is used to breathe atmospheric window can also be played in hole 102.

Figure 26 to Figure 28 is various accompanying drawings of describing rotation ell 16 individually, and Figure 29 to Figure 31 is for describing the various accompanying drawings of the anti-valve part 34 that suffocates individually simultaneously.

Figure 28 A has described another embodiment of the present invention, comprising the similar rotation ell 16 of the rotation ell shown in planting with Figure 22 16 '.One of them main difference is, rotation ell 16 ' comprise being used to get rid of the CO that the patient breathes out ₂The single hole 20 of gas '.Hole 20 ' duckbilled valve well known in the prior art (duck bill valve) can be housed.

On Figure 28 A-1 and Figure 28 A-2 have described a kind of ell of slightly revising, wherein, hole 20 " being convexly equipped with out and valve part 23 ' be connected to hole 20 ".

In the embodiment of Figure 28 A, Figure 28 A-1 and Figure 28 A-2, parts 23,23 ' formation valve part.In another embodiment, parts 23,23 ' can constitute the selectively stopper of closed hole.When stopper is positioned at suitable position, the sealed and not aerofluxus of ell in hole.When removing stopper, just come out in the hole, therefore as the inlet that receives the pipe that for example comes down to nasal feeding.

Figure 28 B and Figure 28 C have described rotation ell 200 according to still another embodiment of the invention.Ell 200 comprises the aforesaid anti-valve barrier film (not shown) that suffocates.Shown in Figure 28 A, ell 200 comprises dome portion 202 and cylindrical center duct member 204.Upstanding wall 206 and duct member 204 are configured to support the anti-valve part that suffocates.Dome has slit or hole 208 and protruding part 209, and its each performance all is described at this.Offer dome 202 the pinnacle part be the pipe 210, it has first end 212 that extends through the anti-membranous centre bore of valve that suffocates.Pipe 210 has second end (not visible) at the place, pinnacle that intactly is connected in or is arranged at dome 202.Thus, shown in Figure 28 A, dome will only have a hole.

Shown in Figure 28 C, duct member 204 comprises the hole 214 that is arranged on duct member 204 bottoms.In this embodiment, hole 214 is an eye shape, but also can be other Any shape.

Figure 28 D to Figure 28 H has described the similar ell 300 of the embodiment with Figure 28 3 and Figure 28 C according to another embodiment of the present invention.Shown in Figure 28 D and Figure 28 E, dome portion 302 comprises a plurality of concentric, annulus 303 of being convexly equipped with out.Shown in Figure 28 E to Figure 28 H, central tube portion 304 extends to dome portion 302 outsides, but helps CO in arrival ₂The elbow housings that gas is discharged than till before the low side.Interior pipe 310 tops from dome portion 302 begin to extend and pass through the end of elbow housings.The profile at the top 311 of interior pipe 310 is shown in Figure 28 E-Figure 28 G.The cross section that leads to atmospheric opening 313 is littler than the core 315 of pipe 310.Between opening 313 and core 315, form transition 317.This transition for example can be the form of the conical part of convergent.As the embodiment of Figure 28 B and Figure 28 C, central canal 302 comprises hole 314 so that enter pipe 302 inside from the air-flow of gas delivery tube, and this point helps to reduce impedance.

Figure 31-A to Figure 31-I has described face shield assembly 10 according to another embodiment of the present invention.Figure 31-A is the front view of face shield assembly 10, and Figure 31-B is the side view of face shield assembly 10.Reference numeral represented with as above-mentioned one or more embodiment of Fig. 1 relevant as described in parts or part.

Face shield 10 be included in the rotation ell 16 of being set forth in more detail among Figure 31-C to Figure 31-F '.Ell 16 ' comprise air inlet pipe 18 (Figure 31 F), this air inlet pipe 18 comprises the hose end 18a with a plurality of elastic deformable protruding 18b, can be connected to swivel joint 76 selectively or pulls down from swivel joint 76 by protruding 18b.Each protruding 18b comprises the protruding 18c that radially extends, and it is locked in the appropriate location of the groove 76a inside of swivel joint 76.Figure 31-E has represented assembled state.Ell 16 is preferred by for example common

The polyester of Bayer product is made, but also can use other material.Swivel joint 76 can be made by the Merlon of cleaning, but also can use other material.This assembly allows to remove flexible pipe (not shown) under the situation of not damaging the framework integrity.Ell 16 ' the internal geometric size of dome portion and functional similarity in or be same as the described dome of Figure 28 D to Figure 28 H.As Figure 31-G to Figure 31-I, ell 16 ' can be with the anti-valve part 34 that suffocates ' use, the anti-valve part 34 that suffocates ' the described parts of function and Figure 29 to Figure 31 34 similar.

Figure 32 has described head-shield folder 106 according to an embodiment of the invention.This head-shield folder 106 comprises: with as depicted in figs. 1 and 2 head-shield folder socket 24 bonded first ends 108 and with bonded second end 110 of the head-shield band of hood assembly.First end 108 comprises first and second arms 112, and the two can be crooked toward each other in paper plane, thereby clamp-on socket 24.Socket 24 is included in latched position and has suitable projection or key lock 114 (Fig. 1).In order to pull down arm 112 from key lock 114, thereby comprising, each socket 24 a pair ofly relative can push extrusion arm 112 arm spare 116 toward each other toward each other, thus, head-shield folder 106 is placed appropriate position, so that it can be pulled down from outrigger 22 and socket 24.When the relative arm 116 of extruding socket, the structure of folder 106 allows them to eject from socket 24.Each head-shield folder 106 comprises a centre leg 118, and it has the groove 120 of the projection 122 that is used to hold as shown in Figure 2.Figure 33 is the main parallax stereogram of head-shield folder 106, and Figure 34 is the rear perspective view of head-shield folder 106.Certainly, also can use different head-shield folders and folder socket to replace.

Figure 34 A and Figure 34 B described the head-shield folder 106 of another embodiment ', it presss from both sides 106 similar with Figure 32 head-shield extremely shown in Figure 34.Wherein having some can reduce manufacturing cost, make improvement easy to manufacture and/or that strengthen the property.

Figure 35 has described first embodiment according to head-shield 124 of the present invention.Head-shield 124 can be made in the following manner: at first use smooth basically suitable material, and as the polyester annular material,

Leather, cloth, plastics or the like; Along predefined shear line 126 shearings, line or softening head-shield, head-shield 124 can be relocated to and the proximate shape of patient's head thus then.Head-shield 124 can comprise side bandage 128 and preceding bandage 130.Side bandage 128 can have independent otch 126.And in the present embodiment, the main body 127 of bandage has the otch of right quantity, for example is 2-5 otch or more, to reach the optimum head-shield 124 or the covering and the stability of patient's head.In general, when head-shield places patient's head, each otch 126 all in use open form a plurality of open spaces 126 '.

With respect to face shield assembly 10 and patient's head, have side bandage 128 and preceding bandage 130 head-shield 124 fixing as shown in figure 36.Figure 37 has represented to wear the rear perspective view of patient's head of the head-shield 124 that provides to some extent.Should fixedly accept the occiput of head, realize stable thus.As Figure 36 and shown in Figure 37, head-shield comprises a plurality of fold lines 132, this fold line 132 be owing to headband 124 from as shown in figure 35 position to producing as Figure 36 and rearranging of position shown in Figure 37.These default fold lines 132 are acceptable for the use in clinical or the hospital environment.But their incorrect performances with 124 produce otherwise impact.

Figure 38 has described second embodiment according to head-shield 134 of the present invention.Head-shield 134 comprises side bandage 136 and preceding bandage 138.And that head-shield 124 can use is smooth basically, be suitable for the material used as head-shield at the patient.Each side bandage 136 is all made by shearing along default shear line 140.Head-shield 134 can comprise a plurality of additional shear lines 142, and as Figure 39 and shown in Figure 40, it has formed network structure on patient's head.Each open area 142 of shear line 142 formation ', to accept patient's head effectively.Open area 142 ' the provide ventilation of patient's head.Open area 142 ' shape can be polygon, for example triangle or rhombus.Certainly, also can adopt other head-shields to be provided with at patient's head upper support face shield assembly.

Figure 41 has described head-shield 400 according to another embodiment of the present invention.Head-shield comprises side bandage 402,404 and top bandage 406, so that use with face shield shown in Figure 1.Head-shield 400 comprises cutout 408, and it helps to ventilate and guarantees that headband is fully kept.Stripping and slicing 408 helps head-shield to be suitable for patient's head.Head-shield 400 comprises that folk prescription is to stretching retraction part 410.Cutout 408 can be spaced apart thing 409 to be cut apart, and sept 409 is can be by for example pressing and/or Velcro

Deng what removably connect.Figure 42 has described a headband that is positioned on the model patient head.

Disposable characteristic

Face shield assembly 10 can be used by a patient limited useful life, and can not reused by other patients.Cleaning and required time and the cost of completed knocked down products have more so just been saved.And it has been avoided when loss of parts or has assembled a difficult problem that is produced when incorrect.From security reason, it has avoided cross infection.Product should have the performance of disposable product and/or attractive in appearance, with the warning user and stop the use of delaying or be used for a more than patient.

Face shield assembly is set to be used for satisfy the structure of the demand of clinical or hospital personnel.This point has realized that described performance comprises when keeping the required face shield performance of patient: comfortable, minimizing or the like of leaking, and therefore promote the patient to cooperate to treat.

It is disposable presenting according to the sensation face shield, and disposable face guard does not have reusable face shield durable.This face shield on purpose tends to distortion by handling, because its material by the useful life with expection is made, this useful life for example 7-14 days preferably is no more than 7 days.Therefore in addition, this face shield has the characteristic that shows its " service time " by stress whitening (following meeting is set forth in more detail), and provides the degree of aging of mask system and near the indication in service life to the user.The general disposable face guard that does not have caution, in use lost efficacy of this ageing properties and prior art forms contrast, and described use is for example experienced when face shield is under pressure in dismounting, flushing, assembling or the engagement process.

Mask system has to the user and gives a warning, with prompting near the useful life.In addition, aging characteristics are applicable to and stop the patient to intersect the security feature of using, and second user do not want to select or wear used face shield.Like this, aging characteristics make cross infection control easily, and therefore it is very practical in clinical a plurality of patients' environment.

Framework

Framework can be formed by polypropylene, polyethylene, PETE etc., and framework can pass through for example molding process manufacturing of jet moulding.Preferably, framework is made by polypropylene, and has very thin wall part (being about 0.25-1mm, preferred 0.5mm), and described very thin wall part has brought than the more flexible characteristic of typical multipurpose face shield framework.Bendability is wanted just, because it produces little durable sensation.

In an embodiment of the present invention, aging is that demonstration by " stress whitening " realizes.Stress whitening as polypropylene and other for example polyethylene or PETE material too much or the result of distortion repeatedly and producing.Too much like this and/or distortion repeatedly will cause finally that frame material bleaches, and produce term " stress whitening " thus.

Embodiments of the invention have comprised the characteristic that shows stress whitening by the suitable design and/or the combination of parts.For example, can design wall thickness degree and pressure load, can proof stress causing the white the easiest part of being found by the clinician on the face shield that is presented at.For example, outrigger 22, supporting leg 68 shown in Figure 8 can be designed as it and can be out of shape when cooperating with head-shield and in use can show stress whitening.As mentioned above, as Fig. 8 and shown in Figure 9, outrigger 22 has the supporting leg 68 that is easy to around axis 72 bendings, warpage or rotation.Athletic meeting too much like this and/or repeatedly causes stress whitening.In other embodiments, stress whitening can be used to form readable Word message (for example, " replacing face shield " or " abandoning "), and this literal information only occurs after stress whitening takes place.Certainly, face shield can be designed as and makes stress whitening occur in other places.

Stress whitening will provide the vision indication that this mask system had been used.If the development that mask frame is set to make stress whitening takes place as the result of repeated deformation between the operating period, face shield also will provide an ageing process and near useful life's visual indication then.

The development of stress whitening also is used for sending safety warning to the user.By sending the warning that is about to arrive the useful life, therefore, the patient can refuse to use the face shield that in use can lose efficacy carefully.

Although face shield can show the degree of some stress whitenings, having only stress whitening is can not produce damage, causes destructive inefficacy thus.By contrast, the situation of prior art is that face shield shows the trend towards undesirable destructive inefficacy, and the destructive inefficacy for example parts under the situation that does not have warning fractures.

One corresponding but independent feature has further strengthened the disposable characteristic of framework.Some and preferred all parts are designed to be assembled into has the disposable action that fractures.In case mask frame/blow vent and anti-valve and the cushion parts of suffocating are assembled, they are not disassembled under situation about not being damaged so.And, the disposable characteristic of mask system is that face shield can not clean effectively, because it can not be disassembled, this point has shown that further face shield is disposable, cheaply, it has the white headband of easily dirty easy contamination and easy donning, and/or by labelling suitably.

Framework can comprise having the head-shield band of tightening characteristic automatically.This will help clinical department (that is non-patient) not needing to make face shield be fit to wear under patient's the auxiliary situation.Comprise the junction point that is used for two lower head-shield bands from the extended flexible supporting leg 68 of framework.Flexibility has allowed supporting leg folding to patient's head rear, and provides extra length to combining of head-shield band/flexible arm thus when cooperating with mask system, has therefore allowed head-shield to be fixed on patient's head.Then, when face shield and head-shield were positioned at suitable position, supporting leg ejected forward, promptly away from patient's face, applied certain force of strain thus to the end on the zone face shade assembly.This helps avoid with the patient and cooperates.

Cushion

It is some identical structures at least that cushion 14 disclosed herein can adopt, existing as using Full face mask, this face shield comprises top barrier film and bottom profile.Ask for an interview U.S. Patent number 6,513,526, it is incorporated into as quoting all at this.

By cushion being clipped between cushion folder 44 and the framework 12, cushion 14 is connected on the framework 12.But,, also cushion 14 can be connected with framework 12 by utilizing (as tenon and groove) and/or the adherent technology of machinery.

In optional assembly, directly mold casting forming is to framework for cushion, and for example by Overmolded, and framework is made by polypropylene and cushion has TPE to make.

Counter suffocating and/or the backflow pressure loading valve

Be applicable to that the anti-valve that suffocates of rotation ell 16 plays the effect of counter suffocate valve and backflow decompressor.This valve is that ell, valve barrier film 34 and framework 12 are forever assembled by three parts.In order to assemble, barrier film 34 and ell 16 (seeing Figure 23,23A23B) interference fit, then ell 16 for good and all with framework 12 snap fit.This snap fit comprises a undercutting, the groove among Figure 12 66 for example, and it is connected with for example six protruding parts 104 on ell 16.

When flow generator was cut off, perhaps under the failure condition of for example cutting off the electricity supply, valve barrier film 34 was accommodated in position original or that do not prolong.Membranous edge has formed the sealing with respect to the interior pipe 82 of ell 16, and has therefore stoped the air-flow from face shield to arrive air inlet pipe 18 and further enter flow generator.Therefore, valve has stoped gas backstreaming in flow generator, and this flow generator is used for especially with oxygen delivery under the situation of face shield.Just can not get back to flow generator so long as supply to the oxygen of face shield, that is, valve has played the effect of oxygen Steering valve (ODV), and has avoided potential fire.In addition, ask for an interview the U.S. Patent number that transfers Leiximadd Co., Ltd and be 10/433,980 file, it is incorporated into as quoting all at this.

Under the situation of pressurization, gas enters face shield by six slits 102 (Figure 23 B, Figure 24 and Figure 25) on the ell 16, and described ell 16 is connected with round entrance in the framework.Ambient air is imported into the surface 36 (Fig. 3) of the lower surface and the framework 12 of valve part 34.Therefore, valve also can play the effect of anti-asphyxiator.This embodiment has the advantage of the anti-valve that suffocates that surpasses above-mentioned Leix prunus mume (sieb.) sieb.et zucc. moral, and it is to have blocked the air-flow towards air inlet pipe 18.Prevented from like this to be breathed repeatedly from the air of air inlet pipe 18.

When flow generator was opened and exert pressure, barrier film 34 extended from original position and forms sealing with respect to the round entrance (as the surface Fig. 3 36) of framework 12.Described forced air from air inlet pipe 18 in ell, manage 82 around flow and the direct round entrance by framework.Inner circular bead 90 can be from managing 82 end separating, as the section part among Figure 23 A.In this position, the arrangement of valves door part is so that it has the audible noise of energy, as blast of whistle.This can provide a suitable or positive feedback signal to patient/clinician, shows that equipment is installed rightly and/or gas-pressurized is suitably imported.For example the noise of hearing of blast of whistle can be similar to the vibration that produces and produces by a kind of when blowing the reed of musical instrument.

Selectively, can design the effect that a small gap produces blast of whistle.The device of for example anti-valve that suffocates can be set,, thereby give a warning to user or clinician so that when system is not correct assembling, do not produce noise.Normally, according to hobby, face shield can be designed as has or does not have noise.

This design has realized the ell that profile is lower, and this ell is desirable, because it had not only met aesthstic but also had improved the stability of face shield.Another factor of being considered when the design ell is the overall impedance of face shield.What be worth hope is to minimize impedance, the pressure oscillating that takes place when breathing to stop.

Constitute the lower ell of profile a plurality of factors will be arranged.The first, ell plays the effect that is used for membranous shell, and valve is positioned on the contact surface of ell in framework.Reduce the quantity of required parts like this, and further reduced the volume of interface.The second, air inlet pipe 18 and face shield form one greater than 90 ° angle, for example 100 °-120 °.The 3rd, increased the diameter of input cavity.Under the situation of given ell inlet angle, this point has increased the effective cross section long-pending (therefore having lowered overall impedance) of inlet air flow.

The valve anti-valve that suffocates than above-mentioned existing Leix prunus mume (sieb.) sieb.et zucc. moral physically is big, has the impedance littler than the ODV of present use in the ell to be implemented in.

Mask vent

Mask vent is combined in the ell.The full face mask of existing Leix prunus mume (sieb.) sieb.et zucc. moral is combined in the mask frame their blow vent.

Because the structure of blow vent and the anti-valve that suffocates is leaked unintentionally and is essentially zero.This performance part is to have soft relatively part and realize that described soft relatively part for example is the barrier film of being made by for example silicones 34 by the anti-valve that suffocates is set, and it is sealed between framework and the rotation ell.

When adopting Ventilation mask to use, need the calibration blow vent with the ventilation installation.This is crossed range request blocking-up and all leads to atmospheric path, so that lead to atmospheric path by isolated and become feature what blow vent produced.

By blow vent is set, can relatively easily stop the hole that connects the face shield cavity and be positioned at the ell in blow vent downstream, to reach desired isolated on ell.This structure has been eliminated and has been stopped the difficulty of leading to atmospheric big path, and described big path is created in the masking aperture place, the face shield cavity porch of promptly ccontaining patient's face.Can use stopper to stop hole between ell and face shield cavity, but this stop also and can realize simply by finger is placed on the hole.

Compared with prior art, its advantage is to have the framework of three kinds of sizes, and each framework all has blow vent, therefore needs different instruments to calibrate each framework/blow vent.Embodiments of the invention have single ell simply, to calibrate for the independence that guarantees air-flow, mask frame size.

The anti-valve that suffocates can be used for the multipurpose full face mask, and is because it is made by silicones, firm, can wash and can re-assembly.Thus, the anti-valve that suffocates becomes normal elements, needs less stock and does not need to be the new new anti-valve that suffocates of facial masks exploitation.

Framework port and port cap

The framework port cap is set to meet clinical needs.Port cap is incorporated in the soft cushion structure, and soft cushion structure allows port cap to form when making cushion, has therefore removed the needs of independent manufacturing.This just can adopt a molding operation to make cushion and mask part.Also can make port cap pass through the produce and market process as parts and cushion.This has simplified processing and inventory logistics, and has reduced and made and store cost.

Port cap is provided with in the following manner with respect to the position of cushion: when cushion was connected on the framework, port cap just easily was positioned, and was connected with the framework port.

These character needs frequently mount and dismount port cap (for example, the framework port connect during the dismounting circuit or when measuring treatment pressure, during the SERVO CONTROL flow-generator or transmission during as the treatment gas of oxygen) clinical the setting in very welcome.Because port cap is attached on the cushion, so it is connected with the framework port at an easy rate always.

And port cap has one or more big handle wings, to promote easy operation.The problem that the inventor found is that the typical portlet medicated cap that is used for the face shield of prior art is a worry for common clinical users.The handle wing can be used for one group of port cap or individually be connected with each port cap.

Preferably, port and port cap are positioned at the bottom of face shield, to avoid the interference with the miscellaneous part of face shield assembly, are described in 6,439,230 the file as the Application No. that transfers Leiximadd Co., Ltd, at this it are incorporated into as quoting all.Certainly, port and port cap can be other the suitable location on the mask frame.And, a plurality of ports and port cap can be provided to identical face shield.

Head-shield

Head-shield is set up in the mode that can reflect the system aging characteristic.This characteristic can show that by using the material that its dirt accumulation is promptly stain realizes.Selected material build dirt also shows gathering of dirt by for example vision and haptic signal.Preferably, the head-shield that uses for the first time is generally white or other light colours.

Except objective visual signal, stain the aging characteristics of realizing by perception a useful psychological information will be provided.When the clinician tended to select new mask system for the patient, particularly when the unfamiliar patient of face shield is cooperated, the potential user did not want to wear the head-shield of serious contamination.

Dirt can be owing to skin, antiperspirant, oil, facial secretions etc.By a kind of mode, aging characteristics can be incorporated in headband and/or the mask frame, and described mode is that headband or mask frame show service time according to the exposure about the dirt source.Just, dirt can provide a sign on the headband framework, should change mask system with the bulletin clinician.

In other optional embodiment, aging characteristics can be included in to reuse and surpass the head-shield that weares and teares or decompose after the general provision limit.

The head-shield band structure has been considered the more suitably bandage position under patient's ear, so can avoid bandage to contact with the irksome of ear bottom.

Head-shield can be made of the die-cut limit part of for example sheet-like material, and described sheet-like material to minimize and reduces cost/control thus and be shaped in order to make to consume when unassembled form.China's husband's form (waffle pattern) will can take into account the correct placement of expanding and being positioned at head upon deployment.This design has realized the structure of 3 cooperations.Use the material components of two dimension to realize having 3 head-shields of the performance of 4 or 5 head-shields.This is a layout of having considered the top bandage, the route below on ear, forming, and the effect that reaches with head-shield with four bandages is similar.Though and that the head-shield of above-mentioned four bandages can disperse ideally is stressed, do not have the convenience of a top bandage.

The head-shield folder

The head-shield clamp device comprises and the bonded shell of release projection, and release projection forms the part of framework.It is to insert socket in the mode of resilient engagement that head-shield is clipped in a side, and plays effect as the head-shield junction point at opposite side.Head-shield connects side and has two slits.First slit 111 (Figure 32 to Figure 34) of close face shield, this slit is the slit that is completed into that head-shield can pass.Second slit 113 of close headband has big shaping projection 115 in a side, has a clearance G between projection 115.The taper of clearance G and projection allows head-shield to pass second slit through projection and connect by pulling down.This package technique is simpler than screw thread.

The further advantage of design of folder is, press from both sides very greatly, makes thus to operate to be more prone to.The projection 116 (Fig. 1) of unclamping folder promotes that from top and bottom operation the user disposes easily.And projection 116 is parts of framework, rather than the part of folder.Therefore, lappet slides with folder, and this can make one-handed performance more simple.

The head-shield folder can comprise the design of ladder lock introduction.Head-shield folder can be used as quick back-off assembly, and promptly to unclamp be the mechanism of unclamping fast to Jia elasticity.It has the projection of holding of exaggeration, so that easily find whether need unclamping of response fast.

The head-shield folder allows rapid artificial assembling.Owing to considered presenting of complete completed knocked down products, so the effect that rapid artificial assembling is played the auxiliary of manufacturing and brought benefit to consumer; Owing to considered the quick assembling when needing, rapid artificial assembling has brought benefit for clinical setting.

The summary of the general effect of preferred embodiment

Hospital and the use that comprehensively has hospital's characteristics have following characteristics: single patient uses, the clinician requires and/or stop reusable hope.

The convenience that cooperates can design by head-shield elastomeric element/outrigger and realize.That assembles has conveniently avoided incorrect assembling and has protected mask system not suffer interference and damage.Do not allow between cushion and framework, to dismantle, because their permanent connections.Ell snaps over framework by unidirectional hasp, and it does not have cannot take apart under damage or the destructive situation at ell and/or framework.Port cap forms as an intact part of cushion, has therefore avoided it to lose or be disassembled.

Face shield is designed to stop to reuse, because have no idea to clean effectively, as because can not enter the anti-valve that suffocates.And face shield shows used evidence, for example, and by stress whitening and stress deformation.Stress whitening can be used for realizing by the combination of some materials, the making of size, version and/or flexible flexible part of wall.Described material can comprise polypropylene, polyethylene or PETE, and can make by mold casting forming, is vacuum formings as jet moulding or they.Can provide stress whitening by outrigger, represent stress whitening but also can utilize upper bracket, forehead supports, the port cap of framework to wait.And, also can use hinges to show used evidence.

Comprise hasp with respect to a kind of optional way of stress whitening, thus to stop constraint to be reused by unidirectional connection.Other possible indications comprise the exposure to air, oxygen or dirt, to concentrate (humidity indicator), CO ₂Exposure, detector or the like.

Mask frame appears as disposable and is not durable, and this judges that by following one or more standards standard is that material is selected, color (head-shield is white, and framework also can be white).Head-shield can be the cardboard with inner plastics, material thickness, simple structure and/or exposed structure method.It is disposable that face shield should be, and for example, framework is flexible and owing to predetermined and/or the multiple application of force are out of shape.

The structure of port and medicated cap is advantageous, because it is the parts with the cushion one, and can not be split under the situation of assembling.Therefore, port cap can not lost, because it is connected on the cushion.Owing to make cushion and medicated cap become parts rather than two, so reduced manufacturing cost.This has also organized the patient to intersect use.

Port cap comprises one or more big handle wings, and it is easier to operation, especially for the clinician.The big handle wing has been considered and has been easy to the location.The handle wing is visual, and has represented that they open or close, and their operation is conspicuous for unfamiliar user, has therefore avoided the mistake that medicated cap is taken off.

Port cap is a self poisoning, and this is meant that medicated cap remains near the port when pulling down, but needs less sensitivity that port cap is placed back on the port, and does not need visual affirmation, because this affirmation can obtain by tactile manner.

Port cap is positioned at the bottom of framework, and this framework is close to nose, so help supplying with oxygen.Port cap is to be difficult for affectedly, can be interfered by the motion of patient's head.Port cap allows air admission pipe and swivel joint to rotate freely.The prevailing position of air admission pipe is always away from the bottom, and less pipe can easily be transmitted along the pipe that exists usually.

Optional embodiment comprises the hinges that is molded as from framework.It has the advantage that shows as the used evidence of stress whitening.

In embodiment further, barb head can be stowed by framework or cushion wall, by this barb head to frame seal.Port cap can be molded, and has the thin bandage that directly links to each other with cushion or framework.Port cap can be sandwiched between cushion and the framework, has reduced the probability that port cap is lost like this.Port cap can be molded as with framework.Port cap can be integrally molded into the anti-valve or blow vent or any elastomer member of suffocating.Port cap can be made into by trip destination does not use one to embody hospital's use, therefore passes on the disposable characteristic of face shield.Alternatively, port cap can be developed out the crop with excessive use.

The aforesaid characteristic of tightening automatically makes face shield assembly be suitable for the patient.Automatically the spring of tightening provides elasticity when needed, for example originally head-shield is being placed overhead the time.This has allowed opening bigger when adaptive.And it also can use with non-resilient head-shield, and is particularly suitable for third party/clinician's adjustment.

Automatically the characteristics of tightening provide a spring with between the tension bandage during initial mating to some tension force.This has prevented simply coming off of bandage, and has prevented the confusion of bandage.

Automatically the characteristics of tightening provide the indication of vision, have shown that bandage do not tighten or strain.In another embodiment, can provide tightening indicator, it shows the degree of tensioning by angle (this can simultaneously about the patient) or by permanent distortion, with for the clinical evaluation after using the patient.

Automatically the characteristics of tightening have kept head-shield not to be subjected to patient's upset, and can comprise wide junction point, and this junction point keeps bandage correction and non-warping.

Automatically the characteristics of tightening can show used evidence, for example by the stress whitening owing to use.Used evidence also can prove by use, thickness and the version of various combinations of materials.Outrigger also can in use be deformed to a point, and after the patient used, the distortion at this some place can not recover.

In optional embodiment, outrigger can be used on the reusable face shield.The head-shield folder can use at hasp under the certain force of strain.Preferentially being like this can be kept form and a bigger opening degree, but do not play the effect of spring.This can provide a very strong use indication by do not keep form after using for the first time, and uses the back suggestion that product is thrown away single patient.

Overhanging assembly can comprise hinges, and it has the advantage of following aspect: maintenance form and bigger extent of opening, but do not play the effect of spring.This can provide a very strong use indication by do not keep form after using for the first time, and uses the back suggestion that product is thrown away single patient.This will embody at the hinge point place and use.

In other optional embodiment, tighten spring automatically and will be connected on the head-shield rather than framework.And tightening indicator can be by simultaneously about patient's angle, or shows the degree of tensioning by permanent distortion, with for the clinical evaluation after patient's use.Hinge can be the part that quilt that the part of cushion or cushion frame have a common boundary ties down, rather than part frame.This hinge can be introduced into other existing disposable face guard and can re-use in the design of face shield.

Head-shield has some features and and/or advantage according to an embodiment of the invention.For example, head-shield is made by using bandage to design, and the minimum like this manufacturing volume of having changed has just reduced the waste or the invalid use of material.The three-dimensional that the one dimension bandage of this design from make expands to when using is accepted.

The process of making head-shield can be formed by independent punching press or form by cutting out in the circumference of band.Head-shield does not need to cover the too many part of head, can feel nice and cool like this and unshowy.This head-shield has been realized simple and stable design.Different colors can be placed on each side of material, so which is used to distinguish partly is headward and head dorsad during which part.The feasible like this confusion of assembling easily and the bandage parts can not occur.

The optional material that is used for head-shield comprises foamed materials, silicones and/or ventilative material.Material can be elastic or stiff, has different hardness in different directions.And independent band can connect with different hardness.This will allow the elasticity of the independent bandage of head-shield is carried out good adjustment.Various hardness can be passed through will

Band sticks on to wait on the part head-shield or by cross crotch and reaches.Head-shield also can be by forming many separate parts, be laminated to each other and by sewing, gummed etc. they connected.

The invention describes use and the most preferred embodiment that is now considered.The present invention is not limited in the disclosed embodiments, and is opposite, and all the present invention is included for various modifications in technological thought of the present invention and scope and layout of equal value.

Claims (38)

1, a kind of face shield assembly that is used for the patient comprises:

Framework, it has the lateral flanges part that has first hole at least;

Cushion, it has the lateral flanges part that has second hole at least; With

The cushion folder, it has and has the lateral flanges that at least one passes the bar in first and second holes, when described bar passes first and second holes, described bar has the far-end that is fixed on the framework, therefore the lateral flanges part of between the lateral flanges of the lateral flanges part of framework and cushion folder, having clamped cushion, wherein

The lateral flanges of described framework partly comprises at least one beading, and it is configured to when assembling frame, cushion and cushion folder and the lateral flanges of described cushion partly forms sealing.

2, face shield assembly as claimed in claim 1 is characterized in that, the far-end of described bar comprises that one is amplified head, has formed the one way snap with framework.

3, face shield assembly as claimed in claim 1 is characterized in that, framework comprises upright wall member, and it provides support at least a portion sidewall of cushion.

4, face shield assembly as claimed in claim 1 is characterized in that, framework comprises the sidepiece outrigger, and its each outrigger comprises at least one supporting leg that links to each other with framework and is used to receive the socket of head-shield band portion separately.

5, face shield assembly as claimed in claim 4, it is characterized in that, each described supporting leg is made by with resilience, pliable material, and this material allows outrigger to shift to the patient and away from the patient, tighten each head-shield band portion during with face shield assembly on the patient wears automatically.

6, face shield assembly as claimed in claim 1 is characterized in that, also is included in the consumption indicant that is provided with at least one in framework, cushion and the cushion folder.

7, face shield assembly as claimed in claim 6 is characterized in that, described consumption indicant comprises the flexible supporting leg that is arranged on the framework, and described flexible supporting leg stress whitening can occur by repeated bending.

8, face shield assembly as claimed in claim 7 is characterized in that, described supporting leg is by a kind of the making in polypropylene and the polyethylene.

9, face shield assembly as claimed in claim 7 is characterized in that, near service life the time, stress whitening is the form of visual warning message.

10, face shield assembly as claimed in claim 6 is characterized in that, described consumption indicant is activated after use is no more than 14 days.

11, face shield assembly as claimed in claim 10 is characterized in that, consumes indicant and is activated after use is no more than 7 days.

12, face shield assembly as claimed in claim 1 is characterized in that, described framework comprises flexible, thin-walled portion, the thickness of this part at 0.25mm between the 1.0mm.

13, face shield assembly as claimed in claim 1 is characterized in that, also is included in port that is provided with on the framework and the port cap that forms and constitute one on cushion.

14, face shield assembly as claimed in claim 13 is characterized in that, described framework comprises the groove of the bridge that is used for ccontaining port cap.

15, face shield assembly as claimed in claim 13 is characterized in that, port cap comprises the flank part of expansion.

16, face shield assembly as claimed in claim 1 is characterized in that, also comprises the ell assembly that is connected with the front surface of framework.

17, face shield assembly as claimed in claim 16 is characterized in that, described ell assembly comprises the protruding part that is used for the framework undercutting of at least one.

18, face shield assembly as claimed in claim 17 is characterized in that, protruding part forms one way snap with undercutting and is connected between ell assembly and framework.

19, face shield assembly as claimed in claim 16 is characterized in that, the ell assembly comprises the anti-valve part that suffocates.

20, face shield assembly as claimed in claim 19 is characterized in that, the ell assembly comprises the cheese part that has the inner circular column jecket.

21, face shield assembly as claimed in claim 20, it is characterized in that, the described anti-valve part that suffocates comprises cylindrical basically hole and outer ring portion, described hole limits an inner circular bead, this inner circular bead frictionally is engaged in described inner circular column jecket, the upright wall member engagement of described outer ring portion and described cheese part.

22, face shield assembly as claimed in claim 20 is characterized in that, described cheese partly comprises at least one blow vent.

23, face shield assembly as claimed in claim 22 is characterized in that, described at least one blow vent comprises the duckbilled valve that is arranged on the blow vent.

24, face shield assembly as claimed in claim 21 is characterized in that, the outer ring portion of the anti-valve part that suffocates comprises the bonded shoulder of edge part with cheese upright wall member partly.

25, face shield assembly as claimed in claim 19 is characterized in that, the anti-valve part that suffocates comprises elastomeric material.

26, face shield assembly as claimed in claim 1 is characterized in that, also comprises in use face shield assembly being supported on patient's head-shield on one's body.

27, face shield assembly as claimed in claim 26 is characterized in that, described framework comprises the socket that is fixed on the head-shield folder on the head-shield band that is used to receive separately.

28, face shield assembly as claimed in claim 27 is characterized in that, described socket comprises as the relative the first arm of the part of framework and second arm.

29, face shield assembly as claimed in claim 28 is characterized in that, each head-shield folder comprises the first arm and second arm, and when the head-shield folder inserted socket, the first arm of head-shield folder cooperated with the relative the first arm and second arm of socket with second arm.

30, face shield assembly as claimed in claim 26, it is characterized in that, also comprise the head-shield coupling part of at least one, this part comprises first slit that the head-shield band is inserted, with second slit that has a gap, can be inserted into second slit by this gap head-shield.

31, as any described face shield assembly in the claim 26, it is characterized in that head-shield comprises the smooth basically material that has at least one otch on it, wherein, otch in use can launch, to form the open area at least on all sides of part material.

32, face shield assembly as claimed in claim 31 is characterized in that, described otch comprises a plurality of otch, in use launches to form net around the occiput of patient's head.

33, face shield assembly as claimed in claim 31 is characterized in that, each open area comprises polygon.

34, face shield assembly as claimed in claim 31 is characterized in that, described material is vulnerable to dirt or grease effect of accumulation, therefore provide the consumption indicant, and it can not be cleared up.

35, face shield assembly as claimed in claim 26 is characterized in that, head-shield comprises at least three points that are connected with framework.

36, as any described face shield assembly in the claim 1 to 35, it is characterized in that face shield assembly is the disposable face guard assembly.

37, face shield assembly as claimed in claim 1 is characterized in that, face shield assembly is the full face mask assembly.

38, face shield assembly as claimed in claim 1 is characterized in that, face shield assembly is the nasal mask assembly.

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