CN100577232C - Mask system - Google Patents

Abstract

The present invention relates to a mask system comprising: a frame (12), cushion (14), cushion clip (44), swivel elbow (16), headgear (124), and/or headgear clip (106) for use in a clinical or hospital environment. One or more components of the mask system are used to facilitate single patient use, such as by providing an aging indicator to prevent disassembly, or cleaning.

Description

mask system

Cross Reference to Priority Application

This application claims U.S. Provisional Application Nos. 60/533,229, filed December 31, 2003, 60/571,488, filed May 17, 2004, and 60/588,341, filed July 16, 2004 , and application Ser. No. 60/619,022, filed October 18, 2004, which is hereby incorporated by reference in its entirety.

technical field

The present invention relates to a disposable mask system for a patient, such as an adult patient, for the treatment of obstructive sleep apnea (OSA: obstructive sleep apnea), or for ventilation by using continuous positive airway pressure (CPAP: continuous positive airway pressure), two-stage, or other pressure support ventilation to provide non-invasive positive pressure ventilation (NIPPV: non-invasive positive pressure ventilation) support. The mask is intended for single patient use, as well as for short-term use, such as a 7-14 day lifetime. Preferably, the mask is only usable up to 7 days.

Background technique

Resmed Ltd's Disposable full-face masks consist of a frame with a double-walled silicone cushion. Upholstery, elbows, and/or vent components can be removed from the frame. While this mask has a strong seal and comfort, it does not exhibit the characteristics that are optimal for hospital and clinical use, unlike those that are optimal for home or other use.

)，该面罩具有PVC泡沫软垫和苯乙烯框架。来自Respironics的映像3一次性的全罩式面罩(Image3 Disposable FullFace Mask)具有框架和硅树脂软垫。又有一种全罩式一次性的面罩是具有单独PVC软垫和框架的Respironics频谱一次性的全罩式面罩(Spectrum Disposable Full Face Mask)。梅德2100序列一次性的全罩式面罩(Med Series 2100 Disposable Full Face Mask)具有PVC框架和泡沫软垫。还有一种面罩是“Performa Trak”，是来自Respironics的单一使用的全罩式面罩。Another prior art is ResMed's Disposable Nasal Mask (ResMed's Disposable Nasal

), the mask has PVC foam upholstery and a styrene frame. The Image3 Disposable Full Face Mask from Respironics has a frame and silicone cushion. Yet another full face disposable mask is the Respironics Spectrum Disposable Full Face Mask which has a separate PVC cushion and frame. The Med Series 2100 Disposable Full Face Mask has a PVC frame and foam cushion. Yet another mask is the "Performa Trak," a single-use full-face mask from Respironics.

The prior art masks described above do not provide an entirely adequate and/or optimal solution for using a mask system in a hospital or clinical setting. For example, these masks exhibit one or more properties typically associated with reusable masks. Consequently, these masks may be accidentally reused in a manner that creates a risk to the patient, such as the risk of spreading germs and the like.

Contents of the invention

It is a feature of the present invention to provide a mask system which at least partially overcomes the problems of the prior art.

Another feature of the present invention is to provide a disposable face mask that has an expiry date, ie it can be used alone or within a shorter period such as 7-10 days or more. Preferably, the mask can only be used for up to 7 days.

Another feature of the present invention is to provide a mask having an indication, such as a visual indication, that the mask has been used once, more than once, or beyond a recommended number or duration.

It is yet another feature of the present invention to provide a mask assembly that is difficult to disassemble without damage, thus eliminating multiple uses and preventing removal of safety components such as anti-asphyxia valves.

It is yet another feature of the present invention to provide a face mask that is disposable and/or meets the needs of clinical and hospital settings that are generally different from the needs of face masks used in a home setting.

Masks, on the other hand, are designed to be adjusted by clinicians and nurses.

Another feature of the present invention is to provide a low cost face mask that represents a significant difference between disposable and reusable products in terms of functionality, aesthetics and/or durability.

These and other features of the invention will emerge from the following description of the preferred embodiments.

Description of drawings

Figure 1 is a perspective view viewed from the front left, illustrating a first preferred embodiment of the present invention;

Fig. 2 is the back view of the present invention;

Fig. 3 is a front perspective exploded view of some components shown in Fig. 1;

Fig. 4 is a rear perspective exploded view of some components shown in Fig. 1;

Figure 5 is a bottom view of the mask assembly shown in Figure 1;

Figure 6 is a top view of the mask assembly shown in Figure 1;

Figure 7 is a right side view of the mask assembly shown in Figure 1;

8 is a perspective view of a frame according to an embodiment of the present invention;

Figure 9 is a rear view of a frame according to an embodiment of the invention;

Figure 10 is a top view of a frame according to an embodiment of the present invention;

Figure 11 is a bottom view of a frame according to an embodiment of the present invention;

Figure 12 is a side view of a frame according to an embodiment of the invention;

Figure 12A is a perspective view of a frame according to another embodiment of the present invention;

Figure 13 is a front perspective view of a cushion according to the present invention;

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

Figure 15 is a rear view of a cushion according to the present invention;

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

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

Figure 18 is an exploded partial sectional view showing the frame, cushion and cushion clip assembly;

Figure 19 is a partial cutaway view showing the assembly of the frame, cushion and cushion clip assembly;

Figure 20 is an exploded partial cutaway perspective view of the assembly shown in Figure 18;

Figure 21 is an exploded perspective view of a swivel elbow according to the present invention;

Figure 22 is an assembled view of a swivel elbow according to the present invention;

Figure 23 is a cross-sectional view of a swivel elbow according to the present invention;

FIG. 23A is an enlarged partial detail view of FIG. 23 .

23B is a perspective and cross-sectional view of an elbow according to an embodiment of the present invention;

Figure 24 is a rear perspective view of a rotating elbow in accordance with an embodiment of the present invention;

25 is a front perspective view of a rotating elbow according to an embodiment of the present invention;

Figure 26 is a rear view of a rotating elbow according to an embodiment of the present invention;

Figure 27 is a bottom view of a rotating elbow according to an embodiment of the present invention;

Figure 28 is a side view of a swivel elbow according to an embodiment of the invention;

28A is a perspective view of a rotating elbow according to another embodiment of the present invention;

28A-1 and 28A-2 are drawings of an elbow according to yet another embodiment of the present invention;

28B and 28C are drawings of an elbow according to an alternative embodiment of the invention;

28D-28H are drawings of an elbow according to yet another embodiment of the present invention;

29 is a front perspective view of an anti-asphyxia valve diaphragm according to the present invention;

30 is a front view of an anti-asphyxia valve diaphragm according to the present invention;

Figure 31 is a side view of an anti-asphyxia valve diaphragm according to the present invention;

31-A through 31-I depict a mask assembly, time tube, swivel and/or anti-asphyxia valve diaphragm consistent with embodiments of the present invention.

Figure 32 is a front view of a hood clip according to the present invention;

Figure 33 is a perspective view of a headgear clip according to the present invention;

Figure 34 is a rear view of a hood clip according to the present invention;

34A and 34B are front and rear perspective views of a headgear clip according to another embodiment of the present invention;

Figure 35 is a perspective view of a headgear according to one embodiment of the present invention;

Figure 36 is a front perspective view of the headgear shown in Figure 35 positioned on a patient's head;

Figure 37 is a rear perspective view of the headgear shown in Figure 35 positioned on a patient's head;

Figure 38 depicts yet another embodiment of a headgear according to the present invention;

Figure 39 is a front perspective view of the headgear shown in Figure 38 positioned on a patient's head;

Figure 40 is a rear perspective view of the headgear shown in Figure 38 positioned on a patient's head;

Figure 41 is a perspective view of a headgear according to yet another embodiment of the present invention; and

Figure 42 is a perspective view of the headgear shown in Figure 41 positioned on the head of a model patient.

Detailed ways

Hereinafter, preferred embodiments of the present invention will be described with reference to the accompanying drawings, wherein the same reference numerals represent the same components.

FIG. 1 shows a mask assembly 10 comprising a frame 12 in the form of an outer shell and a cushion 14 attached to the frame 12 . The swivel elbow 16 is rotatably connected or disposed on the frame 12 . The swivel elbow 16 includes an inlet tube 18 that receives pressurized breathable gas from a suitable pressurized gas source, as is known in the art. The swivel elbow 16 includes one or more holes 20 for continuous venting of CO ₂ gas from the breathing chamber formed by the frame 12 and cushion 14 . Frame 12 includes at least one pair of side outriggers 22 that support connector clips for receiving connector clips (see, eg, FIGS. 32-34 ) attached to headgear (see, for example, FIGS. 35-40 ). socket 24. The frame 12 includes a centrally located upper extension 38 that includes structures for interconnecting with a headgear strap of a headgear.

The frame 12 also includes at least one port 26 for introducing a pressure monitoring probe, or for introducing a single gas such as oxygen ( _O2 ) into the interior of the breathing chamber (via tubing). Said port 26 may suitably be covered by a port cap 28 which, in FIG. 1 , is in a disconnected position. As described and shown below, port cap 28 may be formed as an integral part of cushion 14 .

FIG. 2 is a patient side or rear view of mask assembly 10 . The face-contacting portion of the cushion 14 preferably comprises a two-layer, spaced-in construction as described in US Patent No. 6,513,526, assigned to Resmed, Inc. and incorporated herein by reference in its entirety. However, other cushion structures, such as single-layer or three-layer cushion structures, can also be used without departing from the technical idea and scope of the present invention. Additionally, the cushion may be constructed of silicone, foam, gel, etc., or combinations thereof.

FIG. 2 also depicts the aperture 30 that communicates the intake tube 18 of the swivel elbow 16 with the breathing chamber. Around the aperture 30 there is a substantially circular bracket 32 as part of the frame 12 . The bracket 32 forms a surface for an anti-asphyxia valve diaphragm 34 (see Figures 29-31 for details). As described in more detail below, the anti-asphyxia valve diaphragm 34 is positioned between the bracket 32 and the swivel elbow 16 .

3 and 4 depict front and rear exploded views of the mask assembly 10 as shown in FIG. 1 without the swivel elbow 16 or associated anti-asphyxia valve diaphragm 34 incorporated therein. As shown in FIG. 3 , the anti-asphyxia valve diaphragm 34 is positioned adjacent to the circular support surface 36 of the frame 12 .

The frame 12 includes at least one and preferably a plurality of through holes 40 for alignment with corresponding through holes 42 in the cushion 14 . Cushion 14 is sandwiched between frame 12 and cushion clip 44 . The upholstery clip 44 includes a corresponding number of fasteners or bars 46 disposed, for example, along a flanged peripheral portion 48 of the upholstery clip 44 . The rods 46 are aligned with and pass through the through holes 42 and 40 of the cushion 14 and the frame 12, respectively. The tips of the rods 46 may be snap fit, heat fused or ultrasonically deformable to be mutually secured relative to the through holes 40 , thus effectively clamping the cushion 14 in place between the frame 12 and the cushion clip 44 . The rod 46 may have a tapered enlarged head to pass through the through holes 40, 42 for assembly purposes. However, the enlarged head prevents removal of the frame, cushion clips, and cushion. Therefore, the cushion may be permanently clipped in place, ie difficult to remove, which may be beneficial in a hospital or clinical environment. However, the cushion can be configured to allow optional removal, if desired. The cushion 14 includes side perimeter flanges 50 that may also be sandwiched or clamped between the frame 12 and the cushion clip 44 . FIG. 3 also shows that flange 50 may have a bearing surface integrally connected to port cap 28 by bridge 29 . Optionally, the frame may have bars and the cushion clips may have through holes.

The inner surface 52 of the frame 12 is best shown in FIG. 4 . Adjacent the inner surface 52 is an upstanding wall member 54 that preferably extends along the entire perimeter to form the opening of the frame 12 . Wall 54 provides support for the side walls of cushion 14 and the inner side walls of cushion clip 44 . 5-7 are further assembly views of the frame 12, cushion 14, and swivel elbow 16. As shown in FIG.

8-12 are drawings further describing the frame 12 individually. In Figure 8 it is shown that the frame 12 includes a notch 56 for passing the bridge 29 (see Figures 3, 14 and 15) from the cushion side to the frame side. The frame 12 also includes a plurality of protrusions or castellations 60 for the purpose of assisting in the retention of the anti-asphyxia valve diaphragm 34 in the elbow assembly (see FIGS. 22, 23 and 29). As shown in FIG. 12 , the frame 12 includes a peripheral flange 64 forming a groove 66 through which the swivel elbow 16 is secured to the frame 12 .

8 depicts that the outrigger 22 includes legs 68 each having a first end connected to or disposed on the body portion of the frame 12, and a first end connected to or disposed on the connector clip receptacle 24. Two ends. Preferably, the outriggers form a unitary body comprising the frame 12 and the outriggers 24 . Furthermore, as shown in FIGS. 8 and 9 , the outriggers 22 , such as the legs 68 , may bend, and/or flex, about an axis 72 . The supporting leg 68 can also be configured as a structure that rotates in a manner similar to a hinge. This rotational arrangement has certain benefits, such as automatic headgear strap tensioning and/or age/usage indication, as described more fully below. 10-12 show a top view, bottom view and side view of the frame 12, respectively. 10 and 11 have double-headed arrows schematically showing bending, turning, and/or flexing of the leg 68 about the axis 72 .

Figure 12A is a perspective view of an alternative embodiment of a frame 12'. The frame in Figure 12A is very similar to that shown in Figure 8, with the only major difference being that frame 12' includes 16 castellations 60 instead of 8. The increased number of castellations helps reduce leakage between the elbow and the anti-asphyxia valve diaphragm. However, the number of castellations can vary and can include any number above or below 16, for example.

In another embodiment, one or both ends of the leg 68 may include a portion 70 about which the arm may rotate, bend and/or flex. This will allow the mask to assume various configurations, for example, by moving the outriggers vertically up or down relative to the main body of the frame, as indicated schematically by the arrows in FIG. 9 . Preferably, the legs 68 may be parallel to each other to accommodate the adjustment described above, even though the legs are shown not parallel (ie, trapezoidal) in FIGS. 8 and 9 .

13-15 show various views of cushion 14 alone; and FIGS. 16 and 17 show various views of cushion clip 44 alone.

FIG. 18 is a partial cutaway and exploded view to highlight the connection between frame 12, cushion 14 and cushion clip 44. As shown in FIG. FIG. 19 is an assembled view of the components depicted in FIG. 18 ; and FIG. 20 is a perspective view of the exploded view shown in FIG. 18 . As shown in FIGS. 18-20 , the frame 12 includes a beaded member 13 that helps to provide and ensure a secure seal between the frame 12 and the cushion 14 . Figure 19 shows the bead 13 embedded into the cushion 14, although the cushion 14 may also include grooves or holes for receiving the bead 13. The bead 13 can be seen in FIG. 4 .

FIG. 21 is an exploded view of the swivel elbow assembly 73 including the swivel elbow 16 , the anti-asphyxia valve diaphragm 34 and the swivel joint 76 . Swivel 76 includes a first end 78 connected to inlet tube 18 and a second end 80 connected to a gas delivery tube connected to a pressurized source of breathable gas.

Figure 22 is an assembled view of the components shown in Figure 21; and Figure 23 is a cross-sectional view of the assembled swivel elbow assembly. As shown in Figure 23, the anti-asphyxia valve diaphragm 34 is preferably made of an elastomeric material. The swivel elbow 16 includes a substantially cylindrical inner tube 82 . As indicated by the directional arrows in FIG. 23 , the cylindrical tube 82 may be provided with a baffle between the inlet gas fed through the rotary joint 76 and the exhaust gas. Figure 23A shows a detailed enlarged view of some of the components shown in Figure 23; and Figure 23B is a partial cross-sectional view of an elbow connected to a frame with members 34 in place.

The anti-asphyxia valve diaphragm 34 includes a body 84 that seals and/or interlocks by friction with an upstanding wall member formed as part of the swivel elbow 16 . The anti-asphyxia valve diaphragm 34 also includes a bore 88 ( FIG. 21 ) that includes an internal shoulder 90 for sealing against the outer surface of the cylindrical tube 82 of the swivel elbow 6 ( FIG. 23 ). The anti-asphyxia valve diaphragm 34 includes an external shoulder 94 that prevents the diaphragm 34 from being embedded too deeply in the swivel elbow 16 and allows a sliding fit with the upstanding wall member 86 of the swivel elbow 16 .

Figure 24 is a perspective view of the rotating elbow 16 viewed from the patient's side. Gas is introduced into the domed portion 98 of the rotary elbow 16 through the inlet tube 18 . The swivel elbow includes a plurality of friction enhancing components 100 to ensure that the anti-asphyxia valve diaphragm 34 remains in frictional engagement with the swivel elbow 16 .

As shown in FIGS. 24 and 25 , the swivel elbow 16 also includes a plurality of slots or holes 102 with a plurality of raised features 104 disposed thereabout. The raised member 104 is beveled (FIG. 24) so that when engaging the flange 64 as shown in FIG. 64 and allow the male part 104 to be received in the groove or cutout 66, at which point the parts snap fit to establish the connection. The provision of holes 102 helps to weaken the swivel elbow 16 so that if an attempt is made to detach the swivel elbow from the mask, the portion supporting the raised member or the raised member itself will deform and/or disengage from the swivel elbow 16 , so discard the mask that cannot be used, in which case the patient needs to be replaced with a new mask. However, selective attenuation does not adversely affect mask performance. The aperture 102 may also act as a window for breathing atmosphere when the anti-asphyxia valve component is inoperative.

FIGS. 26-28 are various drawings depicting the swivel elbow 16 in isolation, while FIGS. 29-31 are various drawings depicting the anti-asphyxia valve member 34 in isolation.

FIG. 28A depicts another embodiment of the present invention which includes a swivel elbow 16' similar to the swivel elbow 16 shown in FIG. One of the main differences is that the swivel elbow 16' includes a single hole 20' for exhausting _CO2 gas exhaled by the patient. The holes 20' may be fitted with duck bill valves known in the art.

Figures 28A-1 and 28A-2 depict a slightly modified elbow in which the hole 20" protrudes and a valve member 23' is attached to the hole 20".

In the embodiment of Figures 28A, 28A-1 and 28A-2, the parts 23, 23' constitute valve parts. In another embodiment, the parts 23, 23' may constitute plugs that selectively seal the holes. When the plug is in place, the hole is sealed and the elbow is not vented. When the plug is removed, the aperture is exposed, thus serving as an inlet for receiving, for example, a tube that is essentially a nasal feeding.

28B and 28C depict a swivel elbow 200 according to yet another embodiment of the present invention. The elbow 200 includes an anti-asphyxia valve diaphragm (not shown) as described above. As shown in FIG. 28A , the elbow 200 includes a domed portion 202 and a cylindrical center tube member 204 . Upstanding wall 206 and tube member 204 are configured to support anti-asphyxia valve members. The dome has a slot or hole 208 and a raised feature 209, each of which is described herein. Providing the pointed portion of the dome 202 is a tube 210 having a first end 212 extending through the central bore of the anti-asphyxia valve diaphragm. Tube 210 has a second end (not visible) integrally connected to or disposed at the apex of dome 202 . Thus, as shown in Figure 28A, the dome will have only one hole.

As shown in FIG. 28C , the tube member 204 includes a hole 214 provided at the bottom of the tube member 204 . In this example, the hole 214 is in the shape of an eye, but could be any other shape.

28D-28H depict an elbow 300 similar to the embodiment of FIGS. 283 and 28C according to another embodiment of the invention. As shown in FIGS. 28D and 28E , the domed portion 302 includes a plurality of concentric, protruding rings 303 . As shown in Figures 28E-28H, the central tube portion 304 extends outside the domed portion 302, but before reaching the lower end of the elbow housing which facilitates _CO2 gas venting. An inner tube 310 extends from the top of the domed portion 302 and through the end of the elbow housing. A cross-sectional view of the top 311 of the inner tube 310 is shown in FIGS. 28E-28G . The opening 313 to the atmosphere has a smaller cross-section than the central portion 315 of the tube 310 . A transition 317 is formed between opening 313 and central portion 315 . The transition may for example be in the form of a tapered conical part. 28B and 28C, the base tube 302 includes holes 314 to allow gas flow from the gas delivery tube to enter the interior of the tube 302, which helps reduce impedance.

31-A through 31-I depict a mask assembly 10 according to another embodiment of the present invention. 31-A is a front view of the mask assembly 10, and FIG. 31-B is a side view of the mask assembly 10. FIG. Reference numerals denote said components or parts in relation to one or more of the above-described embodiments as in FIG. 1 .

Bayer产品的聚酯制成，但也可使用其它材料。旋转接头76可以由清洁的聚碳酸酯制成，但也可使用其它材料。该组件在不损坏框架完整性的情况下允许移除软管(未图示)。肘管16′的圆顶部分的内部几何尺寸和功能相似于或相同于图28D至图28H所述圆顶。如图31-G至图31-I，肘管16′可以与反窒息阀门部件34′一起使用，反窒息阀门部件34′的功能与图29至图31所述的部件34相似。The mask 10 includes a swivel elbow 16', which is illustrated in more detail in FIGS. 31-C to 31-F. Elbow 16' includes an inlet tube 18 (FIG. 31F) that includes a hose end 18a having a plurality of resiliently deformable protrusions 18b through which it can be selectively connected to or from a swivel joint 76. Remove the swivel joint 76. Each protrusion 18b includes a radially extending protrusion 18c that locks in place inside the groove 76a of the swivel joint 76 . Figure 31-E shows the combined state. The elbow 16 is preferably made of, for example, a common

Bayer products are made of polyester, but other materials are also available. The swivel joint 76 may be made of clear polycarbonate, although other materials may also be used. This assembly allows removal of the hose (not shown) without compromising the integrity of the frame. The interior geometry and function of the dome portion of the elbow 16' is similar or identical to that of the dome described in Figures 28D-28H. 31-G to 31-I, the elbow 16' may be used with an anti-asphyxia valve component 34' which functions similarly to the component 34 described in FIGS. 29-31.

Figure 32 depicts a hood clip 106 according to one embodiment of the present invention. The headgear clip 106 includes a first end 108 that engages with the headgear clip receptacle 24 as shown in FIGS. 1 and 2 , and a second end 110 that engages with the headgear strap of the headgear assembly. The first end 108 includes first and second arms 112 that are bendable toward each other in the plane of the paper to squeeze into the receptacle 24 . The receptacle 24 includes a suitable protrusion or key 114 (FIG. 1) in the locked position. To remove the arms 112 from the key lock 114, each receptacle 24 includes a pair of opposing arm members 116 that can be squeezed toward each other to compress the arms 112 toward each other, thereby placing the hood clip 106 in place. , so that it can be removed from the outrigger 22 and socket 24. The configuration of the clips 106 allows them to pop out of the socket 24 when the opposing arms 116 of the socket are squeezed. Each headgear clip 106 includes a central leg 118 having a recess 120 for receiving a protrusion 122 as shown in FIG. 2 . FIG. 33 is a front perspective view of the hood clip 106 , and FIG. 34 is a rear perspective view of the hood clip 106 . Of course, different hood clips and clip receptacles could be used instead.

34A and 34B depict another embodiment of a hood clip 106' that is similar to the hood clip 106 shown in FIGS. 32-34. Among these are improvements that can reduce manufacturing costs, ease manufacturing, and/or enhance performance.

皮革，布料，塑料等等；然后沿预先设定的剪切线126剪切、划线或软化头罩，由此头罩124可以被重新配置到与患者头部近似的形状。头罩124可以包括侧绑带128和前绑带130。侧绑带128可以具有单独的切口126。而且，在本实施例中，绑带的主体127具有适当数量的切口，例如为2-5个切口或者更多，以达到最优的头罩124或患者头部的覆盖和稳定性。一般地说，当头罩置于患者头部时，每一个切口126都在使用中张开来形成多个开口空间126′。Figure 35 depicts a first embodiment of a hood 124 according to the present invention. The hood 124 can be manufactured by first using a substantially flat suitable material, such as a polyester hoop material,

Leather, cloth, plastic, etc.; the headgear is then cut, scored or softened along the predetermined cut lines 126 whereby the headgear 124 can be reconfigured to approximate the shape of the patient's head. Hood 124 may include side straps 128 and front straps 130 . Side straps 128 may have separate cutouts 126 . Moreover, in this embodiment, the main body 127 of the strap has an appropriate number of cutouts, such as 2-5 cutouts or more, to achieve optimal coverage and stability of the hood 124 or the patient's head. Generally speaking, each cutout 126 is opened in use to form a plurality of open spaces 126' when the headgear is placed on a patient's head.

The attachment of the hood 124 with side straps 128 and front straps 130 relative to the mask assembly 10 and the patient's head is shown in FIG. 36 . Figure 37 shows a rear perspective view of a patient's head wearing the provided headgear 124. This fixation bears on the occipital portion of the head, thereby achieving stability. As shown in FIGS. 36 and 37 , the hood includes a plurality of fold lines 132 resulting from the repositioning of the headband 124 from the position shown in FIG. 35 to the position shown in FIGS. 36 and 37 . produced. These preset fold lines 132 are acceptable for use in a clinical or hospital environment. They do not, however, adversely affect the performance of the headgear 124 .

Figure 38 depicts a second embodiment of a hood 134 according to the present invention. Hood 134 includes side straps 136 and front straps 138 . Also, the headgear 124 can be fabricated from a material that is substantially flat and suitable for use as a headgear for the patient. Each side strap 136 is made by cutting along a predetermined cutting line 140 . The headgear 134 may include a plurality of additional shear lines 142, as shown in FIGS. 39 and 40, which form a mesh structure on the patient's head. Each cut line 142 forms an open area 142' for effectively receiving the patient's head. Open area 142' provides ventilation of the patient's head. The shape of the opening area 142' may be a polygon, such as a triangle or a rhombus. Of course, other headgear arrangements may be used to support the mask assembly on the patient's head.

等可拆卸地联结的。图42描述了一个位于模型患者头部上的头带。Figure 41 depicts a hood 400 according to another embodiment of the present invention. The hood includes side straps 402, 404 and a top strap 406 for use with the face mask shown in FIG. 1 . The hood 400 includes cutouts 408 which facilitate ventilation and ensure that the headgear is fully retained. Cutout 408 helps the headgear fit the patient's head. The hood 400 includes a unidirectional expansion and retraction member 410 . Cutouts 408 may be divided by spacers 409, which may be formed by, for example, press fit and/or Velcro

etc. detachably connected. Figure 42 depicts a headgear placed on a model patient's head.

one-time feature

The mask assembly 10 may be used by one patient for a limited period of use and may not be reused by another patient. This eliminates the time and expense of cleaning and reassembling the product. Also, it avoids the difficulties that arise when parts are missing or assembled incorrectly. For safety reasons, it avoids cross contamination. The product should have the performance and/or aesthetics of a single-use product to warn the user and discourage extended use or use on more than one patient.

The mask assembly is configured to meet the needs of clinical or hospital personnel. This has been achieved while maintaining the mask performance desired by the patient, including: comfort, minimization of leakage, etc., and thus promoting patient cooperation for treatment.

The mask appears to be disposable based on the perception that a disposable mask is not as durable as a reusable mask. The mask is purposely tended to distort by handling because it is made of a material that has an intended lifetime, eg 7-14 days, preferably not more than 7 days. In addition, the mask has the property of displaying its "age" through stress whitening (explained in more detail below), and thus provides the user with an indication of the age of the mask system and the approaching end of life. This aging performance is in contrast to prior art disposable masks that generally have no warning of failure during use, for example, when the mask is subjected to stress during disassembly, rinsing, assembly or mating.

The mask system has a warning to the user that the expiration date is approaching. In addition, the aging feature is suitable for safety features that prevent patient cross-use, and a second user does not want to select or fit a used mask. As such, the aging properties allow for easy control of cross-infection, and thus it is very practical in a clinical multi-patient setting.

frame

The frame may be formed from polypropylene, polyethylene, PETE, etc., and the frame may be manufactured by a molding process such as injection molding. Preferably, the frame is made of polypropylene and has very thin wall sections (approximately 0.25-1mm, preferably 0.5mm) which result in a more flexible characteristic than typical multipurpose mask frames . Flexibility is exactly what is desired, as it creates a not-so-durable feel.

In an embodiment of the invention, aging is achieved through the manifestation of "stress whitening". Stress whitening occurs as a result of excessive or repeated deformation of polypropylene and other materials such as polyethylene or PETE. Such excessive and/or repeated deformation will eventually cause the frame material to whiten, hence the term "stress whitening".

Embodiments of the present invention, through appropriate design and/or combination of components, include properties exhibiting stress whitening. For example, wall thickness and pressure loading can be designed to enable control of the portion of the mask where stress whitening manifests most easily to the clinician. For example, the outrigger 22, legs 68 shown in Figure 8 may be designed to deform when mated with the hood and to exhibit stress whitening in use. As noted above, and as shown in FIGS. 8 and 9 , the outrigger 22 has legs 68 that are readily bent, flexed, or rotated about an axis 72 . Such excessive and/or repetitive motion can cause stress whitening. In other embodiments, stress whitening may be used to create a readable text message (eg, "replace mask" or "discard") that appears only after stress whitening has occurred. Of course, the mask can be designed so that stress whitening occurs elsewhere.

Stress whitening will give a visual indication that the mask system has been used. If the mask frame is arranged so that the development of stress whitening occurs as a result of repeated deformation during use, then the mask will also provide a visual indication of the aging process and approaching end of life.

The development of stress whitening is also used to issue safety warnings to users. By providing a warning that the expiry date is imminent, the patient thus carefully refuses to use a mask that would fail in use.

Although masks can exhibit some degree of stress whitening, only stress whitening will not produce damage, thereby causing catastrophic failure. By way of contrast, the prior art situation is that the mask exhibits a tendency towards an undesired catastrophic failure, eg a component snapping off without warning.

A corresponding but independent feature further enhances the one-off nature of the frame. Some and preferably all parts are designed to assemble with a one-time snap-off action. Once the mask frame/vent and anti-asphyxia valve and cushion components are assembled, they cannot be disassembled without damage. Moreover, the disposable nature of the mask system is such that the mask cannot be effectively cleaned because it cannot be disassembled, which further indicates that the mask is disposable, low cost, has a white cap that is easily soiled and easy to wear. tape, and/or be appropriately marked.

The frame may include headgear straps with an automatic tensioning feature. This will assist the clinical department (ie, non-patient) to fit the mask without the patient's assistance. Flexible legs 68 extending from the frame include connection points for the lower two hood straps. Flexibility allows the legs to fold behind the patient's head and thereby provides additional length to the headgear strap/flexible arm combination when mated with the mask system, thus allowing the headgear to be secured to the patient's head superior. Then, when the mask and headgear are in place, the legs spring forward, ie, away from the patient's face, thereby applying some tension to the headgear mask assembly. This helps avoid cooperating with patients.

Upholstered

The cushion 14 disclosed here can adopt at least some of the same structures, as can use existing A full-face mask that includes an upper diaphragm and bottom profile. See US Patent No. 6,513,526, which is hereby incorporated by reference in its entirety.

The cushion 14 is attached to the frame 12 by sandwiching the cushion between cushion clips 44 and the frame 12 . However, it is also possible to attach the cushion 14 to the frame 12 by utilizing mechanical (eg tenon and groove) and/or adhesive techniques.

In an optional assembly, the upholstery can be molded directly onto the frame, for example by overmolding, and the frame is made of polypropylene and the upholstery is made of TPE.

Anti-asphyxia and/or backflow relief valves

The anti-suffocation valve suitable for rotating the elbow 16 plays the role of an anti-suffocation valve and a backflow decompression device. The valve is permanently assembled from three parts, the elbow, the valve diaphragm 34 and the frame 12 . For assembly, the diaphragm 34 is an interference fit with the elbow 16 (see FIGS. 23 , 23A23B ), which is then permanently snap-fitted with the frame 12 . The snap fit includes an undercut, such as groove 66 in FIG.

When the flow generator is switched off, or in the event of a failure such as a power cut, the valve diaphragm 34 is accommodated in its original or unextended position. The edge of the membrane forms a seal against the inner tube 82 of the elbow 16 and thus prevents airflow from the mask from reaching the intake tube 18 and further into the flow generator. Thus, the valve prevents gas from flowing back into the flow generator, which is used in particular in the case of delivering oxygen to the mask. As long as the oxygen supplied to the mask cannot be returned to the flow generator, ie, the valve acts as an oxygen diversion valve (ODV) and avoids a potential fire. Also, see U.S. Patent No. 10/433,980, assigned to Resmed, Inc., which is hereby incorporated by reference in its entirety.

Under pressurization, gas enters the mask through six slots 102 (Fig. 23B, Fig. 24 and Fig. 25) in the elbow 16, which is connected to a circular inlet in the frame. Ambient air is directed to the lower surface of the valve member 34 and the surface 36 of the frame 12 (FIG. 3). Therefore, the valve can also function as an anti-asphyxiation device. This embodiment has the advantage over the anti-asphyxia valve of Resmede described above in that it blocks the flow of air towards the intake duct 18 . This prevents the air from the intake duct 18 from being rebreathed.

When the flow generator is turned on and pressure is applied, the diaphragm 34 extends from its original position and forms a seal against the circular inlet of the frame 12 (eg, surface 36 in FIG. 3 ). The pressurized air from the intake duct 18 flows around the elbow inner tube 82 and directly through the circular inlet of the frame. The internal shoulder 90 can be separated from the end of the tube 82, as shown in section in Figure 23A. In this position, the valve member is arranged such that it makes an audible noise, such as a whistle. This can provide a proper or positive feedback signal to the patient/clinician that the equipment is properly installed and/or the pressurized gas is being properly introduced. An audible noise such as a whistle can be produced by a vibration similar to that produced when blowing the reed of a musical instrument.

Optionally, a small gap can be designed to produce the effect of a siren. Devices such as anti-asphyxia valves may be provided to generate noise to alert the user or clinician when the system is not properly assembled. In general, masks can be designed with or without noise, depending on preference.

This design achieves a low profile elbow, which is desirable for both aesthetics and increased mask stability. Another factor to consider when designing an elbow is the overall impedance of the mask. It is desirable to minimize impedance to prevent the pressure swings that occur during breathing.

There are several factors that make up the low profile elbow. First, the elbow acts as a housing for the diaphragm, and in the frame the valve sits on the interface of the elbow. This reduces the number of parts required and further reduces the size of the interface. Second, the intake pipe 18 forms an angle greater than 90° with the mask, such as 100°-120°. Third, the diameter of the input cavity is increased. This increases the effective cross-sectional area of the intake air flow (thus reducing the overall impedance) for a given elbow inlet angle.

The valve is physically larger than the existing ResMed's anti-asphyxia valve described above to achieve a lower impedance in the elbow than currently used ODVs.

mask vents

The mask vents are incorporated into the elbow. Existing Resmed full face masks have their vents incorporated into the mask frame.

Due to the construction of the vent and anti-asphyxia valve, there is essentially zero inadvertent leakage. This performance is achieved in part by providing the anti-asphyxia valve with a relatively soft part, such as a diaphragm 34, eg made of silicone, which seals between the frame and the swivel elbow.

When using a ventilation mask with a ventilation device, calibration of the vents is required. This process requires blocking the entire path to the atmosphere so that the path to the atmosphere created at the vent is isolated and characterized.

By providing the vent on the elbow, it is relatively easy to block the hole connecting the mask cavity to the elbow downstream of the vent to achieve the required isolation. This configuration eliminates the difficulty of blocking the large path to atmosphere that occurs at the mask aperture, ie the entrance to the mask cavity that accommodates the patient's face. A plug can be used to block the hole between the elbow and the mask cavity, but this blocking can also be accomplished simply by placing a finger over the hole.

This has the advantage over the prior art that there are three sizes of frames, each with a vent, thus requiring a different tool to calibrate each frame/vent. Embodiments of the present invention simply have a single elbow calibrated for airflow, mask frame size independence.

The anti-asphyxia valve can be used in multi-purpose full-face masks because it is made of silicone, which is strong, washable and reassembleable. Thus, the anti-asphyxia valve becomes a common part, requires less inventory and does not need to develop new anti-asphyxia valves for new face masks.

Frame ports and port caps

Frame port caps are configured to meet clinical needs. The port caps are incorporated into the cushion structure which allows the port caps to be formed at the time the cushion is manufactured, thus removing the need for separate fabrication. This enables the upholstery and mask parts to be manufactured in one modeling operation. It is also possible to make the port cap go through the manufacturing and distribution process as a part with the cushion. This simplifies handling and inventory logistics, and reduces manufacturing and storage costs.

The port caps are positioned relative to the cushion in such a way that when the cushion is attached to the frame, the port caps are easily positioned for connection to the frame ports.

These properties are very useful in clinical settings where frequent installation and removal of port caps is required (e.g., when connecting or removing lines from a frame port, or for measuring therapeutic pressure, servo-controlling flow generators, or delivering therapeutic gases such as oxygen). popular. Since the port caps are attached to the soft pads, it is always easy to connect to the frame ports.

Also, the port cap has one or more large handle wings to facilitate easy handling. One problem discovered by the inventors is that the typical small port caps used in prior art masks are an annoyance to the average clinical user. The handle flaps can be used with a set of port caps or individually attached to each port cap.

Preferably, the ports and port caps are located on the bottom of the mask to avoid interference with other components of the mask assembly, as described in U.S. Patent Application No. 6,439,230 assigned to Resmed, Inc., which is hereby incorporated Incorporated by reference in its entirety. Of course, the ports and port caps can be other suitable locations on the mask frame. Also, multiple ports and port caps can be provided to the same mask.

hood

The hood is set in a way that reflects the aging characteristics of the system. This characteristic is achieved through the use of materials that are capable of exhibiting their accumulation of dirt, ie staining. The selected material accumulates dirt and indicates the accumulation of dirt by, for example, visual and tactile signals. Preferably, the hood used for the first time is generally white or other light colors.

In addition to objective visual signals, aging properties through perceived staining will provide a useful psychological information. When clinicians tend to choose new mask systems for their patients, especially when fitting with patients who are not familiar with masks, potential users do not want to wear a heavily soiled headgear.

Dirt can be attributed to skin, sweat, oil, facial secretions, and more. By one approach, aging characteristics may be incorporated into the headgear and/or mask frame in such a way that the headgear or mask frame exhibits age based on exposure to sources of dirt. That is, dirt can provide an indication on the headgear frame that it is time for the clinician to replace the mask system.

In other alternative embodiments, the aging characteristic may include a headgear that wears or decomposes after repeated use beyond generally prescribed limits.

The headgear strap structure allows for a better strap placement under the patient's ears, so annoying contact of the straps with the lower part of the ear is avoided.

The hood may be constructed from, for example, die-cut trim pieces of sheet-like material which, in unassembled form, is shaped to minimize consumption and thereby reduce cost/control. The waffle pattern will allow for expansion and proper placement at the head when unfolded. The design realizes the structure of three-point fit. Use 2D material parts to achieve a three-point mask with the performance of a four-point or five-point mask. This allows for the placement of the top straps, along the lines of the ears forming the underside, and is similar to what is achieved with four strap hoods. Although the above-mentioned hood with four straps can ideally disperse the force, it does not have the convenience of a top strap.

hood clip

The headgear clip device includes a housing combined with the release protrusion, and the release protrusion is formed as a part of the frame. The hood clip is inserted into the socket in a resilient fit on one side and acts as a hood attachment point on the other side. The hood attachment side has two slots. Closest to the first slot 111 of the mask (Figs. 32-34), this slot is a fully formed slot through which the hood can pass. The second slot 113 closest to the headband has large shaped protrusions 115 on one side with a gap G between the protrusions 115 . The gap G and the taper of the protrusions allow the hood to connect by pulling down past the protrusions through the second slot. This assembly technique is simpler than threading.

A further advantage of the design of the clip is that the clip is very large, thereby making handling easier. The clip release tabs 116 (FIG. 1) are accessible from the top and bottom, facilitating easy user configuration. Also, the protrusions 116 are part of the frame, not the clip. Thus, the tab slides with the clip, which allows for easier one-handed operation.

The hood clip can include a ladder lock guide design. The hood clip can act as a quick release device, i.e. the elastic release of the clip is the quick release mechanism. It has exaggerated grip bumps to make it easy to see if a quick-response release is needed.

Hood clips allow for quick manual assembly. Rapid manual assembly serves as an aid to manufacturing and a benefit to the consumer by allowing for the presentation of a fully assembled product and a benefit in the clinical setting by allowing for rapid assembly when needed.

Summary of general effects of preferred embodiments

Hospital and hospital-specific use in general has some of the following characteristics: single patient use, clinician requirements, and/or desire to discourage reuse.

Ease of fit can be achieved through the hood elastic/outrigger design. Ease of assembly avoids incorrect assembly and protects the mask system from tampering and damage. Disassembly between upholstery and frame is not permitted as they are permanently connected. The elbow is snapped together with the frame by a one-way hasp which cannot be disassembled without damage or damage to the elbow and/or frame. The port cap is formed as an integral part of the cushion, thus preventing it from being lost or disassembled.

Face shields are designed to discourage re-use because there is no way to effectively clean them, eg because of no access to the anti-asphyxia valve. Furthermore, the face mask shows evidence of use, for example, by stress whitening and straining. Stress whitening can be achieved through a combination of materials, wall dimensions, structural forms and/or use of flexible bendable sections. The material may comprise polypropylene, polyethylene or PETE, and may be made by molding, such as injection molding, or they may be vacuum formed. Stress whitening can be provided through outriggers, but stress whitening can also be exhibited using frame upper supports, forehead supports, port caps, etc. And, a living hinge can also be used to show evidence of use.

An alternative to stress whitening involves snapping through a one-way connection, thereby preventing re-use of the restraint. Other possible indicators include exposure to air, oxygen or dirt, exposure to concentrates (humidity indicators), _CO2 , probes, etc.

The mask frame appears to be disposable and not durable, as judged by one or more of the following criteria, material choice, color (the mask is white, the frame can also be white). The hood can be cardboard with inner plastic, material thickness, simple construction and/or exposed construction methods. The mask should be disposable, eg, the frame is bendable and deforms due to predetermined and/or repeated application of force.

The port and cap configuration is advantageous because it is an integral part of the upholstery and cannot be disassembled once assembled. Therefore, the port cap cannot be lost because it is attached to the soft pad. Manufacturing costs are reduced by having the pad and cap as one component rather than two. This also organizes patient cross-use.

The port cap includes one or more large handle wings, which are easier to handle, especially for the clinician. Large handle wings allow for easy positioning. The handle wings are visible and indicate whether they are on or off, and their operation is obvious to an inexperienced user, thus avoiding the mistake of taking the cap off.

The port cap is self-locating, which means that the cap stays near the port when removed, but requires less sensitivity for the port cap to be placed back on the port, and does not require visual confirmation as this can be achieved by Tactile way to get.

The port cap is located at the bottom of the frame, which is close to the nose so it facilitates oxygen delivery. The port cap is insensitive and will not be disturbed by movement of the patient's head. Port caps allow air to enter the tube and the swivel to rotate freely. The most common place for air to enter the tubes is all the way away from the bottom, and smaller tubes can easily be routed along the tubes that normally exist.

Alternative embodiments include living hinges molded from the frame. It has the advantage of showing evidence of use such as stress whitening.

In a still further embodiment, the barb head may be pulled through the frame or upholstered wall by which the barb head seals against the frame. Port caps may be molded and have thin straps that attach directly to the pad or frame. The port caps can be sandwiched between the upholstery and the frame, which reduces the chance of the port caps being lost. The port caps can be molded with the frame. The port cap can be integrally molded with the anti-asphyxia valve or vent or any elastomeric component. The port cap can be made unused by the tourist destination—reflecting hospital use, thus conveying the disposable nature of the mask. Optionally, port caps can be developed with overused cut ends.

The self-tensioning feature as described above allows the mask assembly to fit the patient. Self-tensioning springs provide resilience when needed, for example when initially placing the hood on the head. This allows for a larger opening when fitting. Furthermore, it can also be used with non-elastic hoods and is particularly suitable for third party/clinician adjustments.

The self-tightening feature provides a spring to impart some tension when tightening the initial fit between the straps. This prevents the strap from simply falling off and prevents a mess of the strap.

The self-tensioning feature provides a visual indication that the strap is not taut or stretched. In yet another embodiment, a tension indicator may be provided which shows the degree of tension either by angle (which may be patient-related at the same time) or by permanent deformation for clinical assessment after patient use.

The self-tightening feature keeps the hood out of the way of the patient and can include wide attachment points that keep the straps aligned and untwisted.

The self-tightening feature can show evidence of use, for example by stress whitening due to use. Evidence of use can also be demonstrated by the use of various material combinations, thicknesses and structural forms. The outriggers may also deform in use to a point where the deformation cannot be restored after use by the patient.

In an alternative embodiment, the outriggers may be used on reusable masks. The hood clip can be snapped on under some tension. Such a preference is to maintain the form and a large opening, but not to act as a spring. This can provide a strong indication of use by not maintaining the form after the first use, and recommend that the product be thrown away after a single patient use.

The outrigger assembly may comprise a living hinge, which has the advantage of maintaining form and a greater degree of opening, but does not act as a spring. This can provide a strong indication of use by not maintaining the form after the first use, and recommend that the product be thrown away after a single patient use. This will reflect usage at the hinge point.

In other alternative embodiments, the self-tensioning springs would be attached to the hood instead of the frame. Furthermore, the tension indicator may display the degree of tension either by angle with respect to the patient simultaneously, or by permanent deformation, for clinical assessment after patient use. The hinge may be part of the cushion or the tethered part of the cushion frame junction rather than part of the frame. The hinge can be incorporated into other existing disposable and reusable mask designs.

Hoods according to embodiments of the invention have certain features and/or advantages. For example, the hood is manufactured using a strap design, which minimizes the manufacturing volume, ie reduces wasted or ineffective use of material. The design extends from a one-dimensional strap in manufacture to a three-dimensional takeover during use.

The process of making the hood can be formed by a separate stamping or by cutting within the perimeter of the strip. The hood doesn't need to cover much of the head to keep it cool and unobtrusive. This hood achieves a simple and stable design. A different color may be placed on each side of the material for distinguishing which part is towards the head and which part is facing away from the head. This allows for easy assembly and no clutter of strap parts.

带粘贴在部分头罩上、或通过十字缝等来达到。头罩也可以通过形成多单独部件、彼此层叠并通过缝纫、胶合等将它们连接。Alternative materials for the hood include foam, silicone and/or breathable materials. Materials can be elastic or inelastic, with different stiffness in different directions. Furthermore, individual strips can be connected with different stiffnesses. This will allow for a fine adjustment of the elasticity of the individual straps of the hood. Various hardness can be obtained by adding

The tape is attached to a part of the hood, or is achieved by cross-stitching, etc. The hood can also be formed by forming separate parts, layered on top of each other and joining them by sewing, gluing or the like.

The present invention describes the most useful and most preferred embodiment presently considered. The present invention is not limited to the disclosed embodiments, on the contrary, various modifications and equivalent arrangements within the technical idea and scope of the present invention are included in the present invention.

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.

Images