CN101991897B

CN101991897B - Respiratory mask assembly having adjustable pad accorded with ergonomics

Info

Publication number: CN101991897B
Application number: CN201010287077.3A
Authority: CN
Inventors: 雷恰尔·E·穆尔; 安德鲁·M·普赖斯; 菲利普·R·夸克; 安东尼·M·金; 萨德·纳斯尔
Original assignee: Resmed Pty Ltd
Current assignee: Resmed Pty Ltd
Priority date: 2002-04-23
Filing date: 2003-04-22
Publication date: 2014-02-26
Anticipated expiration: 2023-04-22
Also published as: CN101991897A

Abstract

The invention relates to a respiratory mask assembly having an adjustable pad accorded with ergonomics. The respiratory mask assembly for delivering breathable gas to a patient comprises a frame having a front surface and a rear surface fit for being opposite to the face of the patient and a pad comprising a side wall detachably connected to the frame, wherein the pad is provided with a frame extended from the side wall along the direction away from the side wall and a film almost around the frame; a hole is arranged on the inner edge of the film; and the hole has a shape of regular trapezoid.

Description

Meet ergonomic and adjustable padded respiratory mask assembly

The application is Chinese patent application No.03133031.2 (denomination of invention: meet ergonomic and adjustable padded respiratory surface assembly; The applying date: dividing an application on April 22nd, 2003).

The related application of mutual reference

The serial number that Moore etc. is enjoyed in the application's request is the priority of 60/377,254,60/397,197 and 60402,509 U.S. Provisional Application, and the full content of described these applications is introduced the application as a reference.

Invention field

The present invention relates to nasal mask, in continuously positive air duct pressure (CPAP of the nose) treatment of described nasal mask for the conveying non-intruding normal pressure ventilating air (NPPV) for carrying out such as blocking sleep breathing (SDB) the imbalance states such as sleep apnea (OSA) and nose.

Background of invention

In the patent No., be 4,944, in 310 U.S. Patent application, provided about being used for the treatment of the instruction of the nCPAP of OSA, at this, its full content is incorporated herein by reference, in the nCPAP of OSA treatment, the Compressed Gas of supply patient air guide channel entrance or other breathable gas, under the pressure higher than atmospheric pressure, are generally 4-20Cm water column and come " punching " open patient's upper air passage and prevent from suffocating with this.

Device for delivery of nasal CPAP and NPPV treatment typically comprises a blower fan, an air delivery conduit and patient's contact surface.Described blower fan can programme to provide a series of multi-form treatments.In one form, air or the breathable gas with constant pressure are offered to patient.The size that changes treatment pressure according to patient's needs is well-known for breathing.This form of therapy is considered to the CPAP treatment of self-adjustable nose, if the patent No. is described in 5,245,995 United States Patent (USP) (Sullivan and Lynch), at this, its full content is incorporated herein by reference.NPPV is the form that imbalance is breathed in another kind for the treatment of.In its most basic form, one puts on relatively high gas pressure on patient's mask in the breathing process of respiration phase, and in the exhalation process of respiration phase, relatively low pressure or atmospheric pressure is put on patient's mask.In other pattern, pressure can change in a kind of mode of complexity in the whole breathing cycle.For example, the pressure being applied on mask in air-breathing and exhalation process can change during treating.For example can be referring to the 5th, 704, No. 345 United States Patent (USP)s and International Patent Publication No. are the patent application of WO98/12965 and WO99/61088, all the elements in them are introduced into as a reference.In this manual, term NPPV treatment will be used for describing NPPV and the nose CPAP treatment of form of ownership.

Engaging of patient and NPPV treatment can adopt some forms, as the mask assembly of a mask assembly that protects nose, nose or mouth, protect nose liner or sponge or a mat assembly that protects nose.Mask assembly comprises that the shell of a rigidity, soft face-contact touch liner, forehead support and one and be used for mask to be fixed on the headstock on head typically.

In a known mask assembly, the headstock comprises a medicated cap part that has four straps.In use, described medicated cap part is divided and is combined with patient's occiput.And in use, two bands below extend between medicated cap part and a nasal mask, and two bands above extend between medicated cap part and a forehead support.Can be for example 6,119,693 United States Patent (USP) (Kwok, Mathett and Grant) referring to the patent No., at this, its full content is incorporated herein by reference.

Have some patient's fasteners comprise fast or facilitate relieving mechanism, this is for a patient or clinician are pulled down it from blower fan, air blower tube and/or mask/head frame assembly.Fast or easily relieving mechanism needs interim interrupt local or is useful when the fault due to system causes air-flow on patient's fastener to be ended in NPPV treatment.For example, if application number is 09/482, disclosed in 718 U.S. Patent application, at this, its full content is incorporated herein by reference, by pulling the rope of a convenient location to weaken the hook-and-loop fastener between the headband in engaging, the headstock or mask assembly can be removed with it from patient, described source of engagement conventionally in, as the rear portion of head frame assembly.In another example, as the application number U.S. Patent Application Publication that is 09/504,220 like that, at this, its full content is introduced for your guidance, by removing a headband, the headstock/mask assembly can be removed with it from patient, and described headband connector is directly connected on the support of mask.Also can be 3,990,727 United States Patent (USP) referring to the patent No., described patent discloses a kind of removable connector fast, and described connector seems to be used in SleepNet ^tMiQ ^tMin mask.

Since patient must can sleep when with patient's fastener, so just wish that it is comfortable.In addition, patient's fastener should described in provide a good sealing to prevent or to reduce leakage, or any leakage control occurring better and keep the effect for the treatment of.Since the nose of human body, face and head are there being in shape significant difference, from economic angle, the fastener that can produce face's shape that can adapt to certain limit is important, and fastener does not just need by providing a large amount of models to increase excessive stock like this.Many patient's fasteners are devised, take patient's comfortableness, easily use, adjustability and the ability that can adapt to large-scale patient face and nose shape are design object.

The patent No. be the United States Patent (USP) of 5,243971 (Sullivan and Bruderer) provide patient's fastener in a kind of NPPV of being suitable for use in treatment (protect nose and protect whole facial mask all can).Described mask has one to be arranged on a face's contact portion on shell, described shell be take certain size and dimension production as covering a nose of wanting wearer, and it is a kind of form of film of upholding that described face is removed part, and described film is moulded and formed by a kind of plastic material film.The patent No. is that 5,243,971 full content is introduced into for your guidance at this.

The patent No. is 6,357,441 and 6,112, and the United States Patent (USP) of 74 (Kwok and Styles) has been described respectively a kind of nose liner that protects, and described liner comprises a support for triangularity substantially, from described support, extends a film.The full content of these patents is hereby incorporated by.

It is 5,724,965 and 6,119 that other nasal mask is disclosed in the patent No., and in 694 United States Patent (USP), their full content is introduced for your guidance.They have described respectively a kind of nose liner that protects, described in protect that nose liner engages with nose or that part of nose above the upper lip in patient just in horizontal plane.In PCT/US00/11329 (WO00/69521), its full content is incorporated herein by reference, and one leg-of-mutton protects the side that nose liner comprises a taper, and described taper reduces to patient's face.Some in the mask/liner of these prior aries face very large challenge at patient's comfortableness, the potential aspects such as nostril obstruction, stability and/or sealing (especially in the bridge of the nose and cheek region).

Many adjustable forehead support are developed out, and target is can obtain a firmly sealing when increasing the patient population of patient's comfortableness and adaptation maximum quantity.For example, the patent No. is that 6,119,693 United States Patent (USP) (Kwok, Mathett and Grant) has been described a kind of adjustable forehead support for nasal mask or whole facial mask.Described forehead support can regulate for the shape and size of different face sides.In this invention, with respect to the sealing angle of face, can adjust.The patent No. is that the full content of 6,119,693 United States Patent (USP) is incorporated herein by mutual reference.In International Patent Application PCT/AU00/00097 (WO00/78384), a kind of forehead support on respiratory mask that is applicable to being fixed to is disclosed.The full content of International Patent Application PCT/AU00/00097 (WO00/78384) is incorporated herein by mutual reference.

Therefore, provide in the art a kind of and can overcome the defect of prior art or the mask of shortcoming is necessary.

Invention summary

An aspect of of the present present invention relates to a kind of comfortable patient's fastener for delivery of NPPV treatment.

Another aspect of the present invention is to provide a kind of meeting and causes improving the patient fastener of patient to the compliance of NPPV treatment.

Another aspect of the present invention is to produce a kind of liner, and described liner is compared with known mask, can be sealed in less nasal area, can keep simultaneously or surpass ResMed and Ultra

the level of comfort of liner.

Another aspect of the present invention is to reduce size that feel and/or actual nasal mask and/or weight and provide a mask of still less charging into for user.

Another aspect of the present invention is to provide a kind of mask assembly, wherein mask and the headstock have the connector that reduces quantity, described connector is configured in position convenient and that energy intuition is felt to can be installed rapidly and/or be taken apart by patient in use, and is not easy unexpectedly to be taken apart.

Another aspect of the present invention is to provide a kind of mask assembly, and the guiding mechanism of a forehead support or a forehead support wherein need not be provided, but in use can keep equally the stability of mask.

Another aspect of the present invention is to provide a kind of nasal mask assembly, and described nasal mask assembly can adapt to large-scale patient, to reduce or reduce the kind of inventory requirements and the mask/liner of the different size that needs to produce.

Yet another aspect of the present invention is to provide a kind of mask assembly that can offer the more comfortablenesses of patient, for example, by avoiding preferably in facial contact region, especially there is undesirable positioning pressure point in patient's responsive nasal bridge region, simultaneously still can keep good sealing, by or by means of normal pressure, do not form or keep sealing.Another aspect of the present invention is when the positioning pressure point of avoiding along bridge of the nose lower area, also will avoid and the contacting of bridge of the nose lower area, and nasal bridge region is that boniness district is to the place of the nose part transition that comprises more cartilages.

Another aspect of the present invention is to avoid undesirable location contact pressure or power, and described pressure or power may increase undesirable nostril by patient and nose path, especially by the gas-flow resistance of nasal cavity.

Also have, another aspect of the present invention is to provide a kind of head frame assembly, and described assembly provides additional stability can to mask/liner.In an embodiment, the described headstock can make or comprise that one deck at least can make the headstock have stiffness to a certain degree to contribute to the structure of mask/liner stability, this can eliminate the needs of forehead support and can reduce the visual disorder to patient's eye thus, and improve or at least do not hinder when mask system is used, patient wears, wears or pluck the ability of eyes.At least a part for headband self can be made for the larger material of pliability by rigid phase.And need not provide a kind of structure of multilamellar.The described headstock can comprise one relatively large, can manual clip member, described clip member can connect or pull down from headband and/or mask support fast and easily.Selective, the headstock can be connected with mask support magnetic.

Another aspect of the present invention is to provide a convenience or relieving mechanism fast, needs small effort and motility just can operate described mechanism.

Another aspect of the present invention is to provide a kind of support, and described support comprises and/or quick release mechanism of all-in-one-piece to such an extent as to clip assembly on the headstock can be pulled down from support at an easy rate.Described quick release mechanism can comprise at least one connector part, and described connector part can be integrally formed with support.The connector part of a cooperation can be arranged in a part for the headstock.Described mask system is connected on a compressed air source, and described compressed air is carried by an airflow pipe.For compressed air being fed to the entrance of patient's air duct, described pipeline can be directly connected on mask, with its inner chamber, is connected with mask chamber fluid.Preferably, there is a connector that airflow pipe is connected on mask.Preferred middleware is a bend pipe connector, and this will be explained in more detail below.Support can comprise one, and from the outstanding protruded tube of the outer surface of mask, described pipe can improve the sealing between bend pipe connector and mask, and also can improve the stability between mask support and bend pipe connector.Protruded tube can comprise that one for being connected to the flange on winding pipe assembly.Preferably, described winding pipe assembly easy operating, so that when patient treatment is ended temporarily, can pull down described bend pipe connector fast and easily from mask support.Described winding pipe assembly can have a vent being connected with atmosphere.Preferably, described vent is connected with air duct system fluid by an exhaust passage, and described exhaust passage is to have separated with inlet channel, for example, can separate by the dividing plate being arranged in a bend pipe connector part with.

Another aspect of the present invention is to provide a kind of trapezoidal mask pad that is conventionally for patient's fastener.

Another aspect of the present invention is to provide a kind of respiratory mask assembly of carrying breathable gas to patient.Respiratory mask assembly according to one embodiment of the present of invention comprises a support with an anterior face and a posterior face, and described posterior face is applicable to for facing patient face.A liner with a sidewall being connected with support removedly.Described liner has the frame that extend away from the direction of sidewall on an edge, and a film substantially arranging around described frame, and the internal edge of described film forms a hole, and described hole has a conventional trapezoidal shape.

Certainly, several respects described in the present invention can form son-aspect of the present invention.Equally, different son-aspects and/or aspect can combine in a different manner, and all form additional aspect of the present invention or accidental.These or other feature of the present invention and aspect will be described in following detailed description, or after reading detailed description part below in conjunction with the drawings, can find out significantly these or other feature and aspect, wherein identical width figure labelling represents identical parts.

Accompanying drawing summary

Appended accompanying drawing makes different embodiments of the invention be easier to understand.In these accompanying drawings:

Fig. 1 be one according to the perspective view of the nasal mask assembly of a preferred embodiment of the present invention;

Fig. 1 b shows one according to the head frame assembly of one embodiment of the present of invention;

Fig. 2 is the Yi Ge partial side view of nasal mask assembly in Fig. 1;

Fig. 3 is a partial front elevation view of nasal mask assembly in Fig. 1;

Fig. 4 is a partial top plan view of nasal mask assembly in Fig. 1;

Fig. 5 is a front perspective view of the holder part of nasal mask assembly in Fig. 1;

Fig. 5 a is a top view of Fig. 5 medium-height trestle;

Fig. 5 b is one and acts on the schematic diagram that may affect patient's different power on the thin part of nasal mask;

Fig. 5 c is the back perspective view of Fig. 5 medium-height trestle;

Fig. 6 a is a top view according to winding pipe assembly and the support of an alternative embodiment of the invention;

Fig. 6 b is a decomposition view of the embodiment in Fig. 6 a;

Fig. 7 is a part sectioned view of Fig. 5 medium-height trestle;

Fig. 8 is the side view of a left side bar of the nasal mask assembly shown in Fig. 1;

Fig. 8 a is according to the zoomed-in view of a right side bar of another embodiment in the present invention;

Fig. 9 a is the top view of a locking clamp of nasal mask assembly shown in Fig. 1;

Fig. 9 b is a bottom view of the locking clamp shown in Fig. 9 a;

Figure 10 a is the side view of clip under complete connection status and support according to the present invention;

Figure 10 b is a bottom view of the clip shown in Figure 10 a;

Figure 10 c is a top view of the clip shown in Figure 10 a;

Figure 10 d is a perspective view of the clip shown in Figure 10 a;

Figure 10 e-10g shows clip and the bar in different link positions of the present invention;

Figure 11 is the perspective view of a bracelet of nasal mask assembly in Fig. 1;

Figure 12 is of the nasal mask assembly bottom view across band under relaxed state in Fig. 1;

Figure 13 be in Figure 12 in across under state across band bottom view;

Figure 14 is across a view across bracelet of being with in Figure 13;

Figure 15 is the perspective view of a band using together with nasal mask group in Fig. 1.；

A perspective view of the swivel elbow in Figure 16 a Fig. 1;

Figure 16 b is the side view of a swivel elbow of nasal mask assembly in Fig. 1;

Figure 17 is a front view of swivel elbow in Figure 16 a and 16b;

Figure 18 is a rearview of swivel elbow in Figure 16 a and 16b;

Figure 18 b is the side view of another embodiment of a swivel elbow;

Figure 18 c is a front view of swivel elbow in 18b;

Figure 18 d is a rearview of swivel elbow in 18b;

Figure 18 e is a cross-sectional view of swivel elbow in 18b;

Figure 19 a-1-19c-2 is the ribbon diagram of the swivel elbow shown in Figure 18, shows along the front surface of support and extends and be connected with an edge;

Figure 20 is the perspective view of a Ventilating hole hood of nasal mask assembly in Fig. 1;

Figure 21 is a rearview of Ventilating hole hood in Figure 20;

Figure 22 is a bottom view of Ventilating hole hood in Figure 20;

Figure 22 b be one for the perspective view of another embodiment of the Ventilating hole hood that is connected with Figure 18 b swivel elbow;

Figure 22 c is a rearview of the Ventilating hole hood in Figure 22 b;

Figure 22 d is a bottom view of the Ventilating hole hood in Figure 22 b;

Figure 22 e is a side view of the Ventilating hole hood in Figure 22 b;

Figure 22 f is one and shows the side view that Ventilating hole hood in Figure 22 b is connected with swivel elbow in Figure 18 b;

Figure 23 is the perspective view of the connection tube of nasal mask assembly in Fig. 6 a;

Figure 24 a is a front view of the liner of nasal mask assembly in Fig. 1, shows the structural line of calculating and Aided Design (CAD);

Figure 24 b is the structure side view of a liner in Figure 24 a.Show CAD structural line;

The different perspective views of the liner shown in Figure 24 a that Figure 24 c-24f shows;

Figure 24 g shows a mask pad according to one embodiment of the present of invention, and described liner comprises a barrier film notch;

Figure 25 a is a perspective view of the liner shown in Fig. 1, shows CAD structural line;

Figure 25 b is a front view of the liner in Figure 25 a;

Figure 25 c is a border side view of the liner in Figure 25 a, shows CAD structural line;

Figure 25 d is along a sectional view of Figure 25 b center line 25d-25d, shows CAD structural line;

Figure 25 e is a sectional view along Figure 25 b center line 25e-25e;

Figure 25 f is a sectional view along Figure 25 b center line 25f-25f;

Figure 25 g is a sectional view along Figure 25 b center line 25g-25g;

Figure 25 h is a sectional view along Figure 25 b center line 25h-25h;

Figure 25 i is the figure of the amplification of Figure 25 d, shows typical case (TYP) size (R-radius) of an embodiment;

Figure 26 is the perspective view of an air hose of nasal mask assembly in a Fig. 1;

Figure 27 a-27e is support of nasal mask assembly and the partial section of liner in Fig. 1, shows a series of positions that support and liner are installed and taken apart;

Figure 28 is the partial section of the support of nasal mask assembly in Fig. 1 and a selective embodiment of liner;

Figure 29 a-29d shows the selective hermetically-sealed construction of liner in Figure 27 a-27e;

Figure 30 and 31 shows according to Fig. 1 and designs a different size that mask is used;

Figure 32 a-1-32c-2 shows the additional embodiment connecting between support and liner, and liner shows CAD structural line;

Figure 32 d is the sectional view of an amplification of the support shown in Figure 32 a-1-32c-2;

Figure 32 e has described one for another embodiment of the present invention of engaging between support and liner;

Figure 33 is the perspective view of another embodiment of a support of nasal mask assembly;

Figure 34 is the top view of the bar of nasal mask assembly and another embodiment of head frame assembly

Figure 35 is a zoomed-in view of the right side bar of the head frame assembly shown in Figure 34;

Figure 36 is a perspective view, and described view shows the support in the Figure 33 being connected with 35 head frame assembly magnetic with Figure 34;

Figure 37 is one and shows Figure 33 and plant the schematic diagram that support is connected with head frame assembly magnetic in Figure 34 and 35;

Figure 38 A-38D shows the different perspective views of another embodiment of liner, and liner shows CAD structural line;

Figure 39 A-39D shows the different perspective views of another embodiment of liner, and liner shows CAD structural line;

Figure 40 is a view of another embodiment of a support of nasal mask;

Figure 41 is a bottom view of the support shown in Figure 40;

Figure 42 is the top view that is configured to an embodiment of the liner of being combined with the support shown in Figure 40, and liner shows CAD structural line;

Figure 43 is the rear view of the liner shown in Figure 42, and liner shows CAD structural line.

Detailed description of preferred embodiment

Two main embodiment have been described in accompanying drawing.Although some feature in each embodiment and/or part are identical, some parts and/or parts are different.For example, although an embodiment of winding pipe assembly 60 described in the present invention has been shown in Fig. 1, and Fig. 6 a-6b has expressed the another kind of assembling form of winding pipe assembly 60, and other difference will be described below.And, about several selective method of different piece and/or parts, also can be described below, and these selective methods should be thought the preferred embodiment that the present invention is additional.

As Figure 1-4, a nasal mask 10 according to a preferred embodiment of the present invention, comprise a support 20 and a liner 40, preferred situation is that described liner 40 is connected on support 20 separably, and selective situation has: can utilize co-molded or cross molding technology, glue or mechanical means described dose of pad 40 is for good and all connected on support 20.A swivel elbow assembly 60 and a head frame assembly 80 can be connected on support 20.Fig. 1 shows conventionally when its nasal mask 10 in the time will being installed on human body head.Certainly, for ease of understanding, Fig. 1 shows is slightly away from head, or " suspension " state.Fig. 1 b shows and removes the headstock 80 keeping flat after support 20.Fig. 2 has expressed the left view of mask assembly 10, and Fig. 3 shows its front view, and Fig. 4 shows its top view.In Fig. 2-4, for clarity sake the rear portion of head frame assembly 80 has been removed.

Mask support

As shown in Figure 5, support 20 comprises a prolate body 22, and described prolate body 22 has a mesopore 24 for being connected with swivel elbow assembly 60.Fig. 5 a is a top view of support 20, and its medium-height trestle 20 comprises that one is designed to the main body 20a and the pair of side brackets assembly 20b that match with liner 40, and wherein side stand assembly 20b is preferably integrally formed with the main body 20a of support 20.Fig. 5 a shows the preferable case that two side stand assemblies have same structure.Main body 20a and side stand assembly 20b are designed to certain curvature, and described curvature face mask common and patient's nose both sides adapts.According to one embodiment of present invention, described curvature seamlessly transits from having two limit assemblies of 120 ° of angles, when liner 40 is during in suitable position, in order to prevent contacting near main body 20a face away from patient nose with patient's nose, and side stand assembly 20b is common and cheek partial parallel.Owing to not wishing contact in described part, between each side stand 20b and patient's cheek, keep a segment distance.Yet if desired, side stand assembly 20b can be configured to comprise a comfortable structure, as the mat structure of being combined with patient's cheek region.Such pad can have advantages of that cheek is supported in help when treatment pattern is exerted pressure.

Curved design based on support 20 and other features, the center of gravity CG1 of formed mask assembly 10 (Fig. 5 b) can be nearer with patient's face.Similarly, the rotary-torque or the moment that for example due to the weight of mask assembly, are created on vertical can reduce.For example, when patient is as shown in Figure 5 b vertically during sitting, the gravity of mask assembly 10 can produce the torque with respect to axle A (in paper), and described axle A is horizontal with respect to patient's nose in horizontal plane.Described torque can produce the power that mask assembly 10 is rotated along from axle A to arrow B direction of trending towards, described axle A is conventionally along the upper lip region layout of liner, and such torque can cause patient uncomfortable or/and reduce around nose underbeam region and/or the sealing of cheek portion along upper lip region.Specifically, in approaching the center of gravity CG1 of face, can produce the torque less than the mask with center of gravity CG2, wherein CG2 is further from face.This is because distance d1, the d2 between center of gravity CG1,CG2He face defined the lever (torque=power * lever distance) for weighing torque.Correspondingly, if power or lever distance reduce, torque just can reduce.When lying on one's side, patient also can produce similar torque.Described torque is subject to the impact of bend pipe geometry, comprises the impact such as the category feature of the length with respect to liner and height.Expectation, is reduced to minimum by the lever effective length of assembly, and in addition, this depends on the structure of bend pipe.

Contribute to the factor that reduces distance between mask assembly center of gravity and face to comprise: the design of the design of liner 40, support 20 and the design of winding pipe assembly 60.Another source of torque is winding pipe assembly and 60 is connected of air shooter, and this source may affect the fastness of mask.In fact, air shooter may act on a pressure to winding pipe assembly 60, and described pressure can produce successively one and trend towards the torque that mask assembly is moved with respect to patient.The torque size that acts on patient being caused by the connection between winding pipe assembly and air shooter can be by adopting following winding pipe assembly 60 to reduce, the content of describing corresponding to content shown in Figure 16 a-19c-2.In brief, the lever arm of winding pipe assembly can effectively be reduced, reason is to be designed to be directly connected in air shooter 310 (Figure 26) and does not need a middle rotary connector 300 (Fig. 6 b and 23) between winding pipe assembly and air shooter 310, this by common application in some prior aries.Selective situation is: a rotary connector may be incorporated in pipe.Like this, in the situation that not increasing undesirable torque, can increase a rotational freedom.And because liner 40 is designed at least lip and the dispersive pressure of cheek portion along described liner 40, the probability of rotating in vertical and trend are further reduced.And each cheek region of described liner 40 forms a relatively large contact pressure and accept face, the described face of accepting extends in the vertical direction and widens in the horizontal direction.Similarly, liner 40 is the rotation within cheek region stops horizontal or vertical at least, and this just contributes on patient, liner 40 to be remained on a firmly position.More detailed content about liner 40 will be described in conjunction with Figure 24 a-25I below.With reference to figure 5c, support 20 comprise one be connected with liner 40 be generally trapezoidal groove 26, described groove 26 comprises an inwall 28, outer wall 30 and a trench bottom 32.About groove 26, will further be described in detail below.

Fig. 6 a represents is and the support 20 shown in Fig. 1-5c and slightly different support 20 and the winding pipe assembly 60 of winding pipe assembly 60.Although the main distinction between embodiment is bend pipe 60, yet also there is the difference between support 20, liner 40 etc., by relatively or in conjunction with the description of different piece being below easy to find out and understanding these differences between different accompanying drawings.Identical parts represent with identical Reference numeral.

In Fig. 6 a and 6b, C-clip of winding pipe assembly 60 use is connected with mask 20, described C-clip 23 can stretch to be installed to the inside of circumferential groove 25, and described groove 25 is configured in a part for winding pipe assembly 60, and described winding pipe assembly 60 is by a ULTRA who is similar to ResMed

a kind of machinery adopting in mask is deep in support 20, and this has description in the 09/594775th (Drew etc.) number U.S. Patent application.What accompanying drawing 6b represented is the exploded view of liner 40, support 20, winding pipe assembly 60 and air shooter.C-clip 23 has a surface engaging with the interior table of support 20 to stop undesirable bend pipe 60 to depart from from support 20.In addition, bend pipe 60 can comprise one or more air vent that leads to atmosphere 61, for example, for discharging the carbon dioxide of exhalation.Constructing described air vent 61 is can remain in nasal cavity in order to make to treat pressure.Air vent 61 can cover with a shade assembly 65, and described shade assembly 65 flexibly and can remove and be clipped in one of winding pipe assembly 60 in appearance.Air vent 61 in Fig. 6 a is visual by translucent cover assembly 65.Detailed content about shade assembly 65 and C-clip is 09/502 at the application number of ResMed, 745,09/594, in 775 U.S. Patent application or in application number is the PCT application of PCTAU00/00097 (WO00/78384), all have description, their all the elements are hereby incorporated by.

As shown in Figure 6 a, the inwall 28 of groove 26 is preferably to stretching out a segment distance away from the direction of support 20, and described distance is larger to the distance of stretching out away from the direction of support 20 than outer wall 30.Fig. 5 c and 32d also express the segment distance that inwall 28 stretches out from support 20 and are greater than the segment distance that outer wall 30 stretches out from support 20.As shown in Figure 32 d, the thickness of inwall 28, in the scope of about 1-2mm, is preferably 1.4mm, the thickness of outer wall 30 is in the scope of about 1-2mm, be preferably 1.4mm, and the distance between the top of inside and outside

wall

28,30 is within the scope of 0.5-10mm, is preferably 2mm.In addition, the width of the groove 26 as shown in Figure 32 d between the vertical plane of relative inside and outside

wall

28,30 is 2-10mm, is preferably 5mm.

By taking the relative distance between this inwall 28 and outer wall 30, make between liner 40 and support 20 be connected easier.Because liner and mask support will move together, so inwall 20 provides a signal visual and/or sense of touch of adjusting liner.And (Figure 24 e and Figure 27 a) make the continuation of kneading process easier, and this will narrate in the description in conjunction with Figure 27 a-29d and 32a-1-32c-2 more fully by the guiding sidewall of liner 40 or mid portion 225, to enter groove 26 afterwards.Select the shape of groove 26, for example may be selected to be as shown in Figure 5 c common trapezoidal, to obtain in the situation that do not have additional guiding piece to make liner with respect to the guiding of groove 26 correct location, reach described guiding object groove 26 and should there is more symmetrical shapes such as equilateral triangle, circle, square or rectangular.Certainly liner groove 26 can adopt any in these shapes.

As shown in Fig. 5 c and 6a, support 20 comprises that a locking clamp that is positioned at every one side of support 20 accepts assembly 34, the described assembly 34 of accepting is connected for the locking clamp 82 with a head frame assembly 80 separately (Fig. 9 a and 10a), and each locking clamp is accepted assembly 34 and comprised a composition surface 35 (Fig. 5 c), an intermediate supports hole 36 and be positioned at two lock holes 38 on 36 relative edges of intermediate supports hole.Intermediate supports hole 36 and lock hole 38 have a rectangular cross section conventionally.Each lock hole 38 comprises a lock flange being located thereon 39 (Fig. 7), described flange 39 is for being connected (Fig. 9 a and 9b) with one of a locking clamp 82 locking outthrust 116 separately, about the content of this respect, will be described below.Groove 38 can provide a hole 71 on the outer wall that is positioned at support 20 (Figure 10 a), described hole 71 can be add or substitute the trivial flange 39 (Fig. 7) of determining.Can from Fig. 5 a, find out the hole 71 that is positioned at support 20 bottoms.And in Fig. 4, expressed from the hole 71 at support 20 tops.Hole 71 needn't penetrate the sidewall of support 20.

The thin part of the headstock

Fig. 1 b has expressed head frame assembly 80 according to an embodiment of the invention, in Fig. 1 b, has shown that head frame assembly is in flat condition.

Band and bar

Referring to Fig. 1-4, head frame assembly 80 comprises before a pair of is with 84, is with 84 to be preferably each other mirror position setting before left and right.Before each, with 84, be into conventional " Y " font and have an anterior end of tape 86, top end of tape 88 and a rear portion end of tape 90, they are integrally formed or other mode such as fix by machinery and interconnect.Described band is made by laminated fabric or foam." Breath-o-Prene " that a kind of material Shi You U.S. Accumed company that can buy from the market produces ^tM.Described band fixing can by means of use a hook and a kind of annular material as dimension can synthetic fibre velcro (trade (brand) name), band also available locking clamp 82 is fixed on support 20, described like this band just needn't comprise hook and ring fixture, and this will be described in detail below.As shown in Fig. 1-3 and 8, before being connected in each, is with on 84 a bar 92.Each bar 92 have with corresponding before with 84 the same conventional shapes, and there is anterior end 94, top end 96 and a rear end 98.Each bar 92 is by having the material of a rigidity to make such as plastics etc., and it has the thickness within the scope of 0.3-2.0mm, and preferred thickness is 1mm.The example of plastics comprises nylon 11 and polypropylene.Bar 92 use binding agents, suture or other known mechanical connection manners are with on 84 before being connected in accordingly.Band and bar device can have different pliabilities at different directions, such as being (distortion forming as the gravity in order to stop by swivel elbow, associated catheter etc.) of enduring with all one's will at a first direction, but be pliable and tough in a common direction vertical with first direction.Once mask band is upper in patient's head, and relatively stiffening bar contributes to make support and the appropriate position of liner in user.Although have with front with 84 identical conventional shapes, in described embodiment top end 96 and rear end 98 conventionally do not extend to before with 84 top end of tape 88 and rear portion end of tape 90.Yet in another embodiment, top end 96 can along the whole length of top end of tape 88 extend and with connector 128 one or a shaping (Fig. 1), bar 92 than be front with 84 narrow with box lunch they while combining, the extensible larger material of rigidity that surpasses bar 92 of the front softer material with 84, to prevent or at least to reduce the contacting of the larger material of rigidity of user and bar 92, this contact can bring to stimulate or discomfort.For example, although band and the bar of associated are multiple structures, be double-layer structure, be with 84 and bar 92 can adopt a kind of homogenous material to form, need only patient and feel comfortable and can keep suitable stiffness.

Bar 92 can increase the stiffness with 84 in certain plane and direction.This contributes in use mask assembly 10 to be stable to patient's head.In other planes and direction, bar and can there is different stiffnesses with assembly.For example, described band and bar should described can stop from patient face inwards or outside crooked or curling.Conventionally, when being with 84 to be connected with support 20 with bar 92, described be with 84 and bar 92 should described can keep its position with respect to patient's head.And support 20 needn't provide the supporting component of a frons, compare with the mask with forehead support like this, owing to can making to hinder the degree in the patient visual field to reduce, so just can further increase patient's comfortableness.Certainly, if expect additional stability or comfort, can equip above-described forehead support.Mask support 20 is lower jaw band of unnecessary equipment also, if but expect additional stability or comfort, also can equip a lower jaw band.In addition, except having removed forehead support, with 84 and bar 92 to select to avoid interference patient's sight line.Especially when installing, the anterior end 94 of each bar 92 is connected on the support 20 below patient's eye, and preferably along a crooked radian, extend and lean on through cheek region, the temple of each top end 96 with 84 top end 88 and each bar from Y shape cross point along patient's head stretches out.The rear end 98 of bar 92 is bent downwardly with the rear end 90 with 84 and around ear, in order to be connected with rear portion band assembly 138, this will more at large describe below.Because bar 92 has stiffness, situation is to be with 84 can keep a predefined shape preferably.On the other hand, bar 92 and also there is certain pliability with 84 and carry out adjustment to a certain extent to can adapt to the difference on patient physiological.Bar 92 also can be different to change flexible characteristic along the thickness of its side, and for example, thicker region can be more stiffening.

As shown in Figure 8, each bar 92 has a holding flange 100 being positioned on anterior end 94.Described mounting flange 100 has a Huo Jian hole, hole 101 of leading to hole 103, referring to Fig. 8 a.Two semi-ring flanges 102 are separated from each other by groove 104.The inner radial surface of described semi-ring flange 102 forms interstitial hole 103.Described bar 92 also has an elasticity outthrust 106 that is positioned at the rear portion of mounting flange 100, the front portion of described elasticity outthrust 106 is connected with bar 92, rear portion and bar 92 partition distance 107, and while being applied on elasticity outthrust 106 with convenient pressure, they can be with respect to bar 92 bendings.Elasticity outthrust 106 preferably has the double wedge 108 on a near arc many axles that are positioned at a mounting flange 100.Described elasticity outthrust 106 also has a net grain surface 110 (Fig. 8) or protruding keeper 110a at its free end, and (Fig. 8 a) helps user location, joint and operating flexibility ridge 106.Fig. 8 a is the right bar 92 and with 84 enlarged drawing, and this is in order better to show that the details of bar 92, upper figure have also demonstrated bar 92 and be sewn onto with the mode on 84.Also can adopt other solid mechanical such as lock or friction.

Locking clamp

Locking clamp 82 is connected on each holding flange 100 adjustablely.As shown in Fig. 9 a and 9b, each locking clamp 82 comprises a main body 112.It is upper and protruding from described main body with a kind of parallel mode of routine that two elastic arms 114 are connected to the relative edge of described main body 112.Hook 116 is connected in the free end of each elastic arm 114.

As shown in Figure 10 a, clip 82 can insert and engage receiving element 34 with the locking clamp of support 20 and engage releasedly, in Figure 10 a, only show a clip 82 and its not with the situation of bar 92 assemblings.Each latch hook 116 is received in one of support groove 38 separately (Fig. 5 c).In Figure 10 a, show the end of latch hook 116, the position of the end of described latch hook 116 before in outwardly-bent each receiving element entering on groove 38.Latch hook end when Fig. 4 shows the bonding station in receiving element 71.Certainly, described clip 82 or be at least that latch hook 116 on it can be formed on support 20, and groove 38 or be at least that receiving element 71 can be formed on band and/or bar.

The outer surface that Fig. 4 and 10a also show locking clamp 82a and support 20 is preferably formed a surface that cardinal principle is continuous, and described surface is to connect and unbroken.Preferably, locker 82 is all equally wide with support 20 in every one end, and it is easier that this just makes patient contact location.It is resilient that elastic arm 114 is designed in the plane of locking clamp main body, and this just can further improve locking clamp 82 and links and the easiness of dismantling.This set has improved the Ergonomy performance of relieving mechanism.Thumb by patient just can be located and operational lock clip 82 at an easy rate with a relative finger.Also have, because their size has increased, patient just can operate described locking clamp 82 with minimum motility.In addition, described locking clamp 82 be connected to on 84/ bar 92 so that described locking clamp 82 and be unnecessary with the length adjustment between 84/ bar 92.

Described locking clamp 82 comprises a maintenance flange 118 from main body 112 outside horizontal expansions (Fig. 9 b), described maintenance flange 118 has a central socket 119 extending along an axle of described maintenance flange 118 and two two of being positioned on described central socket 119 relative edges keep ridge 120, and described two keep ridge 120 from central socket 119 horizontal expansions.Figure 10 b-d shows the more details of the locking clamp 82 shown in Figure 10 a, the feature similarity in these details and Fig. 9 a and 9b.Although illustrated locking clamp 82 is separated from bar 92, be appreciated that described clip and bar 92 can form one if relative motion between the two and/or dismounting are unessential.Described clip 82 and support 20 can form an integral unit, and clip portion can be connected with bar.

Keep flange 118 with certain size and dimension manufacture to keep ridge 120 and groove 104 to match, and described maintenance flange 118 is inserted in the mounting flange 100 of bar 92 vertically.Central socket 119 by certain size, manufacture and interstitial hole 103 between there is high tolerance so that locking clamp 82 and bar 92 rotatably support each other.Once keep flange 118 to be inserted in mounting flange 100, locking clamp 82 just can be with respect to bar 92 rotations to keep ridge 120 to engage with the inner surface of flange 102, thus installation clip 82 axial lock are fixed on bar 92, the locking clamp 82 when the diverse location with respect to bar 92 has been shown in Figure 10 e-g.In Figure 10 e, the ridge 120 of clip 82 inserts by the hole of bar 92, and clip 82 rotates and so that the inner surface of the upper surface of ridge 120 and semi-circular part 102 connects airtight closes slightly in the direction of arrow A.When clip 82 is connected so that makes flexible arm 114 in the about 90 degree position of the anterior end 94 with respect to bar 92, clip 82 just can be separated from bar 92.In described embodiment, separation can occur two positions, and these two positions are all through selecting, so that guarantee, when mask is normally used, separation can not occur; Otherwise clip 82 can be optionally from bar 92 dismountings.Figure 10 f and 10g show the clip in diverse location 82 with respect to bar 92.

As seen in Fig. 9 b and 10b, locking clamp also has many double wedges 122 on an arc, near the axle of described arc in maintenance flange 118.Structure and configuration tooth 122 are to engage with the tooth 108 on elasticity ridge 106.Once elasticity ridge 106, be depressed so that tooth 108 reduces, locking clamp 82 just can rotate to respect to bar 92 position of an expectation.Then elasticity ridge 106 can discharge to make tooth 108 engage and rotatably lock locking clamp 82 with respect to bar 92 with the position (in a tooth pitch) of tooth 122 in expectation.According to an embodiment, can configure tooth 108 and tooth 122, when with box lunch, by one, first fixed torque is applied on locking clamp 82, tooth 122 will automatically apply downward pressure to tooth 108 and elasticity ridge 106, to allow locking clamp 82 to rotate, until torque is removed and tooth 108 engages again with tooth 102.Therefore locking clamp 82 relatively bar 92 an about 50-100 ° preferably the angular range inward turning modulation of 75 ° save, this depends on the bonding station between tooth 108 and tooth 122.By the change of tooth 108 and 122 quantity and position, the rotation that can obtain is adjusted angle and can be changed according to desired angle.The scope of described adjustment angle reflects the position of the associated cushion that face is required.Rotation adjustment with tooth system as above allows patient to adjust like a cork and allow to adapt to the scope that between larger different patients, face changes in a large position range.For example, patient can regulate two locking clamps 82 to having identical angle with respect to bar 92.Alternative situation has: patient can adjust locking clamp 82 so that locking clamp has different separately angles with respect to bar 92.Tooth system allows patient like a cork for each locking clamp 82 arranges and arrange expected angle.For example, described tooth system can allow in for example five positions, to relatively move between each locking clamp and its bar separately, and this just can adapt to most face shape.Certainly also can adopt greater or less than five positions, this will depend on concrete practicality.And, after once each desired locking clamp 82 is determined with respect to a special angle of bar 92, described mask system can comprise a non-adjustable clamp apparatus, and described clamp apparatus is the position of rotation with respect to bar 92 for fixedly locked clip.For patient can easily determine that locking clamp is with respect to the relative position of bar, tooth is enough large.

In addition, elasticity outthrust 106 is configured and is arranged to make patient can not optionally depress the structure of elasticity outthrust 106, for example, between sleep period, pass through spin locking clip/bar, makes locking clamp 82 with respect to bar 92 relative motioies.For example, as shown in Figure 10 e-10g and Figure 36 (a different embodiment), locking clamp 82 is further more protruding than elasticity ridge 106.That is to say, elasticity ridge 106 is in the position lower than the outward flange of locking clamp 92.Therefore, locking clamp 82 can stop arbitrarily starting of elasticity ridge 106 with respect to the setting of elasticity ridge 106.And elasticity ridge 106 be connected with bar 92 to such an extent as to described bar 92 is can be from elasticity ridge 106 inside or outwardly-bent and can not make the tooth 108 of elasticity ridge 106 depart from from the tooth 122 of locking clamp 82.

Selective adjustment assembly can by some or all subassembly simply put upside down obtain.For example central socket 119 can be positioned on bar 92, and its corresponding bar interstitial hole 103 can be positioned on locking clamp 82.In a kind of similar mode, each subassembly and its corresponding part can be put upside down.Selective, bar 92 can come adjustable ground to be connected by screw and clamping device with locking clamp 82.For example, a part can be separated with shelf with described bar, and described screw or clamping device can be used for selectively in the position of many expectations, bar being connected with clip 82.In addition, interstitial hole 103 can form by any way, and described mode can allow between bar and clip, to separate and be connected.Also can adopt a kind of permission with respect to locking clamp, to have the alternative system of the bar of fixed angle.

Locking clamp 82 also comprises the support ridge 124 at Yi Ge center, and described support ridge 124 is protruding and between elastic arm 114 and conventionally parallel with elastic arm 114 from main body 112.In the middle of described, ridge 124 is configured to closely cooperate with intermediate supports hole 36, so that when middle ridge 124 injects intermediate supports hole 36, allow has very little rotation, swing or jointly move between locking clamp 82 and locking clamp receiving unit 34.Middle support ridge 124 is longer to contribute to calibration to enter support than arm 114.Locking clamp 82 also has a composition surface 125 engaging with composition surface 35 (Fig. 5 c), and described composition surface 125 can be locking clamp 82 additional support is provided when locking clamp 82 inserts locking clamp receiving unit 34.Latch hook 116 and/or intermediate supports ridge 124 can have the width of taper and/or thickness to be more easily inserted in hole 36,38.Equally, latch hook 116 and/or intermediate supports ridge 124 can have circular or conformal edge to be more easily inserted in hole 36,38.In addition, intermediate supports ridge 124 can have a groove, and the projection of described groove on being configured in intermediate supports hole 36 is combined so that intermediate supports ridge 124 is more easily inserted in intermediate supports hole 36.Available, described intermediate supports ridge 124 can have a protuberance, described protuberance can with the groove contact being configured on intermediate supports hole 36.

When locking clamp 82 is inserted in locking clamp receiving unit 34, and when latch hook 116 is inserted in receiving element 71 (Fig. 4) or crosses lock flange 39 (Fig. 7), elastic arm 114 is applied in pressure in opposite directions.Once latch hook 116, cross lock flange 39 or receiving element 71, elastic arm 114 just can outwards eject to provide the interlocking between latch hook 116 and lock flange 39 and/or receiving element 71 to close.In lockhole 38, provide enough spaces and carry out necessary motion to cross lock flange 39 with permission latch hook 116.

By this way, band assembly before each left and right, before comprising, be with 84, bar 92 and locking clamp 82, all can be connected on support 20, and bar 92 and front with 84 can with respect to support 20 one 50-100 °, preferably in the angular range of 75 °, be rotated adjustment.

In a preferred embodiment, locking clamp 82 be one by jet moulding shape all-in-one-piece working of plastics.The example of plastics comprises nylon, acetal and polypropylene.In one embodiment, keep also molding injection formation in moulding process of ridge 120, remain with the hole 116 connecting along the main body 112 of locking clamp 82 in molding course of injection, therefore keeping the lower surface of ridge 110 is separated with main body 112.

Interconnecting of magnetic

The embodiment removably connecting between a selective support 420 and head frame assembly 480 has been expressed in Figure 33-37.Particularly, support 420 and bar 492 are configured to bar 492 and can magnetic be connected on support 420.

As shown in figure 33, support comprises a main body 420a and pair of side brackets assembly 420b.Similar with the embodiment with support 20, main body 420a is constructed to be permeable to be connected with liner 40 in mode removably.Each side stand assembly 420b comprises a first pontes 434, in order to head frame assembly 480 on the second coupling part 435 of providing of bar 492 couple together.In an illustrated embodiment, the first pontes 434 comprises a maintenance structure 418 extending outward from side stand assembly 420b.Described maintenance structure 418 is configured to for keeping a magnet 419.In one embodiment, magnet 419 be by neodymium, formed and there is columniform shape, described columniform diameter is 6.35 millimeters, thickness is 6.35 millimeters.Yet, keep structure 418 can be constructed to be permeable to keep the structure of any size and dimension magnet.And the outward flange of each side stand assembly 420b comprises the double wedge 422 of many arc shootings.

As shown in FIG. 34 and 35, the bar 492 on each head frame assembly 480 has the structure of the bar 92 being similar on head frame assembly 80.Particularly, each bar 492 contains the second coupling part 435, and described coupling part has a mounting flange 400 on the anterior end 494 in it.Described mounting flange 400 has the hole or the keyhole 401 that lead to hole 403.Two semi-ring flanges 402 are separated from each other by groove 404.The inner radial surface of described semi-ring flange 402 forms interstitial hole 403.Described bar 492 also has an elasticity outthrust 406 that is positioned at the rear portion of mounting flange 400, the front portion of described elasticity outthrust 406 is connected with bar 492, rear portion and bar 492 partition distance 407, and while being applied on elasticity outthrust 406 with convenient pressure, they can be with respect to bar 492 bendings.Elasticity outthrust 406 preferably has the double wedge 408 on a near arc many axles that are positioned at a mounting flange 400.Described elasticity outthrust 406 also has a protruding keeper 410 to help user location, joint and operating flexibility ridge 106 at its free end.

Compare with bar 92, bar 492 comprises a ferrous metal dish 412 being fixed on hole 403.In one embodiment, metal dish 412 is that a diameter is that 14 millimeters, thickness are the steel packing ring of 1 millimeter.Yet metal dish 412 can have any suitable size and dimension, described size and dimension can be installed in the hole 403 on bar 492.And the magnet of suitable dimension and shape can be used for replacing metal dish 412.

As shown in Figure 36 and 37, the second coupling part 435 on the first pontes 434 on support 420 and bar 492 engages, so that magnet 419 can be bonded together with magnetic force with metal dish 412.Particularly, magnet 419 inserts interstitial hole 403 vertically, so that magnet 419 is adjacent with metal dish 412 or engage, this just allows the magnetic pull of 412 of magnet 419 and metal dish bar 492 can be remained on support 420 vertically.As discussed above, with magnet, replace the magnetic pull that metal dish 412 can increase by 420, bar 492 and support.Support 420 and bar 492 keep the size that manufactures a high precision size tolerance between structure 418 and hole 403 so that can rotatably support mutually.

In addition,, when support 420 engages with magnetic force and bar 492, the double wedge 422 on support 420 is constructed and is configured to engage with the gear 408 on elasticity ridge 406.Once elasticity ridge 406, be depressed so that tooth 108 reduces, bar 492 just can rotate to respect to support 420 position of an expectation.Then elasticity ridge 406 can be released to tooth 408 and tooth 422 are engaged and with respect to bar 92 lock bracket 420 rotatably in the position (in a tooth pitch) of expectation.According to an embodiment, can configure tooth 408 and tooth 422, while a predetermined torque being applied on bar 492 with box lunch, tooth 422 will automatically apply downward pressure to tooth 408 and elasticity ridge 406, to allow bar 492 to rotate, until torque is removed and tooth 408 engages again with tooth 422.Therefore bar 492 can be with respect to support 420 at an about 50-100 ° of preferred angular range inward turning modulation joint of 75 °, and this is by the bonding station depending between tooth 408 and tooth 422.

Magnet 419 on each side stand assembly 420b has directions, to such an extent as to wrong connection (for example the bar 492 in left side is put on the side stand assembly 420b on right side) can be identified by the repulsion of magnetic force.Particularly, magnet 419 on a side stand assembly 420b has directions, therefore, described magnet 419 only can be connected by magnetic force with one of bar 492, and the magnet on another side stand assembly is also to have definite direction, to such an extent as to it only can be connected by magnetic picture with the another side of bar 492.Therefore, between support 420 and head frame assembly 480, the judgement of the sense organ of exact connect ion is to obtain by correct magnetic pull of matching between bar 492 and side stand assembly 420b.This structure can be guaranteed the correct installation between the thin part 480 of the headstock and support 420.And, because magnet 419 can be positioned at correct position by himself with respect to metal dish 412 automatically, though therefore in the dark described structure also can make support 420 engage with head frame assembly 480 at an easy rate.By applying a suitable breakaway force that is greater than the magnetic pull between magnet 419 and metal dish 412, just can easily head frame assembly 480 be separated from support 420.

Alternative, the first pontes 434 on support 420 can configure a ferrous metal dish, and the second coupling part 435 on bar 492 can configure a magnet.

belt

Before each, with 84, comprise a bracelet 128 that is connected to the ladder shape on heading tape 88, described bracelet is used for heading tape 88 and a heading tape 140 of halved belt 138 to link together.Referring to Fig. 1-3 and 11.Bracelet 128 can link together by gummed system, sewing and/or other known method and heading tape 88, as being made of one with belt.In the embodiment shown in fig. 11, bracelet 128 comprises and manyly with square, is evenly distributed on a hole 130 connecting on ridge 132, and described hole 130 can be made on heading tape 88 cingulum.Described cingulum also comprises a horizontal stripe 134 and a horizontal stripe 136, around described horizontal stripe heading tape 140, can pass in a kind of known mode.Therefore heading tape 140 is wound around along horizontal stripe 136, and the free end of heading tape 140 is between horizontal stripe 134 and heading tape 140 remainders.Therefore, when applying tension force between buckle in 128 and heading tape 140, the free end of heading tape remains between horizontal stripe 134 and heading tape 140 remainders by frictional force, so being connected between bracelet 128 and heading tape 140 can automatic control under tension force.The bracelet of a single horizontal stripe also can be used when using with a band engagement of loops and belt is fixed on to correct position.Certainly also can adopt other the coupling assembling of replaced bracelet as known in the art.

As shown in figure 12, halved belt 138 has a conventional elongate shape under the state loosening, and has two heading tapes 140 to extend upward from having the cross band 142 of end 144.For halved belt 138 being placed to the structure that is applicable to wearing, two heading tapes 140 pass from an intersection button 146, so they are maintained at the position of intersection.Referring to Figure 13 and 14.In this manner, the left heading tape 140 of halved

belt

138 and 128 interconnections of buckleing of right heading tape 88, meanwhile, the right heading tape 140 of halved

belt

138 and 128 interconnections of buckleing of left heading tape 88.The intersection of this each belt can contribute to make the thin part 80 of the headstock and nasal mask 10 at the user adjustable position in an expectation with it.Zone circle 148 can be pushed down the free end of each belt.Referring to Figure 15.In a kind of form of the present invention, provide the belt of lengthening, can be cut into afterwards the length that is applicable to user.

88 similar mutually with bracelet 128 and heading tape, bracelet 150 (Fig. 1) can be connected on cross band end 144 so that make cross band end 144 can with each before with the rear portion end of tape 90 on 84, couple together.

Swivel elbow assembly

Swivel elbow assembly 60 shown in Fig. 6 a can with the ULTRA that is applied at present ResMed company

in mask, in mask, adopted as mentioned above an inner C-clip assembly.Winding pipe assembly 60 in Fig. 6 a intends to be used for being connected with a connection tube 300 (Figure 23).Described connection tube 300 is equipped between winding pipe assembly 60 and air shooter 310 (Figure 26).

Selective, winding pipe assembly can be constructed shown in Fig. 1-4 and 16-22.Such winding pipe assembly 60 can comprise a swivel elbow 160 and a Ventilating hole hood 180.Swivel elbow 160 is rotatably connected with support 20.

In another alternative form of the present invention, an other revolving part is connected in the end of pipe 310, as shown in Figure 6 b.

As shown in Figure 16 a-19c-2, swivel elbow 160 comprises an inlet channel 162 and an exhaust passage 164.Air hose 310 (Figure 26) is preferably directly connected (without connection tube 300) with the bar portion 166 of swivel elbow assembly 160, to provide the breathe air of compression or gas for patient respiratory, the air of described compression or gas come from a compression supply source and offer patient by air hose 310, inlet channel 162 and inner liner 40.

162 of exhaust passage 164 and inlet channels are with being separated out such as dividing plate 161 etc., and described dividing plate 161 is configured in the inside of bend pipe 160.Referring to Figure 18 and 19a-1.In an illustrated embodiment, dividing plate 161 has a conventional planar configuration.Yet described dividing plate 161 also can have a curved configuration or other suitable constructions is separated air vent 164 and inlet channel 162.Select the direction of inlet channel 162 and exhaust passage 164 so as to use introducing gas that the direction arrow in inlet channel 162 represents less directly stagnation along exhaust passage 164 air-flows of draining.Say further, since dividing plate 161 forces, introduce gas by a winding raod line, the gas that enters so bend pipe 160 has the probability that less flows directly into exhaust passage 164, for example, can, by before 164 Exhaust Gas of exhaust passage, need Rotate 180 degree.

Bend pipe 160 comprises that is applicable to the end portion 169 engaging with the hole 24 being configured on support 20, and described bend pipe provides gas for the nasal cavity to support 20 and liner formation.Dividing plate 161 is just in the interior termination of end portion 169 of bend pipe.A pliable and tough quick release mechanism comprises a lasso 173 and a skirt thing 170.Lasso 173 comprises a conventional T shape assembly, and as shown in Figure 16 b, described T shape assembly is around the end 169 of bend pipe 160.Preferably, the end 169 of bend pipe 160 extends beyond lasso 173 to improve calibration effect on being assembled into support 20 time.As shown in figure 18, lasso 173 is concentric and be separated from each other to form the reception space 183 between a lasso 173 and end portion 193 with end portion 169.Skirt thing 170 is preferred and bend pipe 160 is integrally formed, and is connected with the lower shank of T shape lasso 173.Two grooves 167 are configured between lasso 173 and skirt thing 170.It is flexible that a part of 167a of groove 167 allows the lower shank of T shape lasso 173 to divide with respect to skirt thing 170.The lateral part of a part of 167b permission T shape lasso 173 of groove 167 is inwardly or outwards flexible with respect to the end 169 of bend pipe 160.

Figure 19 a-1-19c-2 shows the successive views that bend pipe 160 is connected with support 20.Figure 19 a-1-19a-2 shows the viewgraph of cross-section of the bend pipe 160 before being connected with mask support 20.Figure 19 b-1-19b-2 shows in approaching bend pipe 160 and the support 20 of link position, and Figure 19 c-1-19c-2 shows bend pipe 160 and the support 20 in abundant link position.

Support 21 comprises a flange 21 that is configured in an end of a wall 25, and described wall 25 forms hole 24.Fig. 5 and 5a show flange 21, yet since used a kind of different winding pipe assembly 160, the embodiment of Fig. 6 a does not illustrate or comprised such flange.When flange 21 injects space 183, it engages with the elongator 181 being formed on lasso 173 inner surfacies.In the present embodiment, only dispose two elongators 181.Elongator 181 has certain gradient, so as with the bending (19b-1-19b-2) that each end that causes T shape lasso 173 lateral parts is outside that engages of flange 21, until (19c-1-19c-2) in groove 167b calibrated and be received in to flange.Under described state, along with bend pipe 160 is fixed on support 20, lasso 173 turns back to its non-case of bending.Flange 21 parts rely on the socket 165 being disposed in space 183.

Between bend pipe 160 and support 20 pass through thump-action connection procedure in, the joint that lasso 173 and flange are 21 can cause audible click or sound hint, and this sound hint is favourable sending to user that bend pipe 160 is firmly connected in aspect the signal on support 20.

For bend pipe 160 is discharged from support 20, the part 185 being positioned on every one side of lasso 173 curves inwardly mutually, and this is in order to make elongator 181 radially outwardly to allow flange 21 to pass through.By this way, bend pipe 160 can be rapidly and easily from support 20, is removed and can not enter the inside of nasal cavity.This occurs in the situation (Fig. 6 b) that bend pipe connects with a C-clip.As shown in Figure 16 b, a preferred form of bend pipe 160 includes has a texture projection 185 for what help user location point of release.Relative have distance between texture part 185 namely the diameter of lasso 173 be 35-45mm, and be preferably 40mm.

Bend pipe 160 is also for being directly connected with air shooter 310 (Figure 26), there is no connector 300 (referring to Fig. 1) as shown in figure 23.Fig. 6 b shows the connector 300 between bend pipe and air shooter 310.It is favourable removing connector 300, and this is that described torque is applied on support or mask 10 with respect to patient's head/face because the effective lever length of bend pipe and connector 300 combinations can increase undesirable torque level.By elimination, use the needs of connector 300, the effective length of lever arm can be reduced, and this just causes the torque being applied on mask assembly less, and this will make stability increase.Along with the stability increasing, patient's comfortableness improves and is more obedient to.

In connection status, the inner surface of wall 25 of support 20 and the outer surface sealed engagement of the end portion of pipeline 169 as shown in Figure 19 a-1-19c-2.The be bonded with each other distance of one section of about 1-10mm of these surfaces, preferred 6mm, this will contribute to sealing and the stable connection between bend pipe 160 and support 20 will be provided.As Figure 19 c-1-19c-2, a part for arm 25 puts in mask 20, has further increased the contact area between bend pipe 160 and support 20.In connection status, the outer surface 20c of the end portion 173a of lasso 173 and support 20 is in same plane, as shown in Figure 19 c-1-19c-2.Wall 25 comprises a flange 25a (Figure 19 c-2), and described flange 25a is used for providing one to end and allow to have a controlled gap between bend pipe 160 and support 20 for the insertion of end portion 169.In one embodiment, the gap between bend pipe 160 and support 20 is minimum.In another embodiment, between bend pipe 160 and support 20, provide a kind of sealing to produce to stop to leak.

This system can make to couple together fast and accurately between bend pipe 160 and support 20.But also can dismantle simply.And bend pipe 160 is configured to allow patient with a hands, bend pipe 160 be connected to support 20 or dismantle from support 20.If this remove mask or within a period of time patient select therapy discontinued, and be favourable while resuming treatment after a bit of time.Being connected between winding pipe assembly 60 and support 20 allows patient fast bend pipe 160 to be pulled down and mask support, liner and the headstock remained on to the correct position of patient's head from the air shooter of pressure fan when instantaneous treatment is interrupted.So since hole 24 is enough large to reduce resistance and can regulate enough gas can make patient respiratory smooth and easy by hole 24, specifically, there is an at least 180mm in hole 24 ²area.In one embodiment, there is the diameter range of a 20-30mm in hole 24, and a 200-600mm ²areal extent, preferably at 500-600mm ²scope in.As shown in the figure, common round-shaped of described Kong Youyi.Yet described also can have a non-circular shape.In addition, support can have many through holes, by these hole bend pipes, engages the frame to such an extent as to bend pipe surrounds these holes.In this respect, according to the mask described in one embodiment of the present of invention, be different from the mask means that comprises quick release machinery and have narrower hole of the prior art, the quick release machinery in this narrower hole can make patient feel under the weather, for example, occur anxiety or claustrophobia.This discomfort can be due to the exhalation CO increasing ₂or the flow resistance increasing and worsening.

ventilating hole hood

Ventilating hole hood 180 comprises main body 182, and described main body 182 is by bottom hole 184, sweep 186 and top 188.See Figure 20-22.Main body 182 at least comprises an air vent 190 simultaneously, and in a preferred embodiment, many air vents 190 extend to the outside of Ventilating hole hood from the inside of Ventilating hole hood.The top 188 of Ventilating hole hood 180 comprises that a flange or hole 192 engage with the pin 168 of rotary connector 160 being used for.In illustrated embodiment, Ventilating hole hood 180 comprises a hole 192.By the bar 166 of rotary connector 160 is connected to Ventilating hole hood 180 on rotary connector 160 through the bottom hole 184 of Ventilating hole hood 180.Ventilating hole hood 180 moves until sell 168 and extends through hole 192 to rotary connector 160, as shown in Figure 1.Because Ventilating hole hood 180 is fixed by bend pipe 160 or air shooter, so this structure allows Ventilating hole hood 180 to remain near winding pipe assembly and/or mask assembly 10.This is for being easily when cleaning or will remove Ventilating hole hood 180 by accident, so can not fall down loss because it is stayed on mask assembly always.

Sweep 186 is installed near the dividing plate 170 of rotary connector, to a conventional hermetic seal is provided between Ventilating hole hood 180 inside and rotary connector 160.In this manner, from the inner expellant gas of a mask, can flow through the exhaust passage 164 of rotary connector 160, through the inside of Ventilating hole hood 180, by air vent 190, be discharged in atmosphere.Figure 19 c-1 comprises an arrow B, and described arrow B has been described the roughly discharge route when Ventilating hole hood place gas in position time.Thisly be furnished with the stimulation that direction that an additional advantage is exactly air vent reduces or prevented from causing to patient's associate from mask air-flow out.Fig. 1-4 show rotary connector 160 and Ventilating hole hood 180 in connection status.Escapement 163 has guaranteed there is sufficient interval between Ventilating hole hood 180 and the outer surface of bend pipe 160 since and Ventilating hole hood preferably of soft resilient material, make, described escapement 163 contributes to prevent the air gap fracture especially.Certainly, if necessary, described Ventilating hole hood also can adopt a kind of plastics family to become to assign to make, and this plastic components is a little as at Ultra Mirage ^tMthe cover of upper use, in addition, this air vent is arranged and can be replaced or be supplemented by disclosed ResMed air vent assembly in the U.S. Patent application that is 09/021,541 at serial number, at this, its full content is incorporated herein by reference.

Figure 18 b-18e shows another embodiment of rotary connector, and it represents with labelling 360, and described rotary connector is applicable to being connected with the Ventilating hole hood 380 shown in Figure 22 b-22e.As shown in Figure 18 b, 18c, 18e, rotary connector 360 comprises a flange 361 that is positioned at wall 362 ends, 364 the outlet around exhaust passage of described flange 361.Figure 18 d and 18e have shown inlet channel 365, exhaust passage 364 and a dividing plate 369 that is used for separating inlet channel 365, exhaust passage 364.As shown in Figure 18 e, dividing plate 369 has a warp architecture.Specifically, described dividing plate 369 is when from exhaust passage, 365 entrance extends to the outlet of exhaust passage 365, and it is normally reclinate.Yet dividing plate 369 can have a conventional planar structure that is similar to the dividing plate 161 shown in Figure 19 a-1.Selective, dividing plate can any other suitable structure separate inlet channel 365, exhaust passage 364.As shown in Figure 22 b-22e, Ventilating hole hood 380 comprises main body 382, and described main body has a bottom hole 384, mid portion 386 and top 388.In main body 382, there are many air vents 390 to extend to Ventilating hole hood outside from Ventilating hole hood inside simultaneously.The top 388 of Ventilating hole hood 380 has a lasso 392 to be used for engaging with the flange 361 on swivel elbow 360.By the bar of rotary connector 360 366 is connected to Ventilating hole hood 380 on swivel elbow 360 through the bottom hole 384 of Ventilating hole hood 380.Then Ventilating hole hood 380 moves until the flange 361 that lasso 392 pins on swivel elbow 360 to swivel elbow 360.Lasso 392 is stretched and pushes down the flange 361 of swivel elbow 360 and due to its elasticity, tightly clamp flange 361.In illustrated embodiment, lasso 392 is conventional circle to be applied to flange 361 and wall 362 upward pressures (" annular pressure ") are equally distributed.Be similar to the embodiment of Ventilating hole hood 180, because Ventilating hole hood 380 is fixed by bend pipe 360 or air shooter, therefore this structure allows Ventilating hole hood 380 to rest near swivel elbow 360 and/or mask assembly.Since Ventilating hole hood can just can keep in place to cover the path of giving vent to anger without additional fixation device on bend pipe, it can be considered to " self-sustaining ".In addition,, when patient stretches lasso 392 on flange 361 time, Ventilating hole hood remains on bend pipe by belt bottom hole 184, if this has just reduced the chance that assembling attempts unsuccessfully losing Ventilating hole hood first.

Figure 22 f shows swivel elbow 360 and Ventilating hole hood 380 in link position.As shown in Figure 18 c and 18e, swivel elbow 360 comprises a wall 363, described wall 363 can guarantee there are enough spaces between Ventilating hole hood 380 and the outer surface of swivel elbow 360, since Ventilating hole hood is preferably made of soft resilient material, this especially contribute to prevent to be caused by fracture gas gap.Ventilating hole hood 380 comprises a groove 389 (Figure 22 c) on the inner surface that is positioned at top 388, and described groove 389 is for engaging with wall 363.

Mask pad

Cushion designs becomes to be placed on the face, and is reducing or avoiding, with when face pressure sensitive area contacts, can exerting pressure at its periphery.Some position of face needs special attention to press equilibrium of forces and sealing to obtain.By improve stability provide a kind of low side mask with improve patient comfort level, and to reduce the power that can make mask rotate relative to patient's face be all desired.To list these characteristics and carry out a method that successfully design is taked below.

The described liner You Yigeyu contact surface He Yigefei of face face's contact surface and have a therebetween wall.The non-face contact surface of liner is connected with mask support.In a kind of form of the present invention, each view as shown in Figure 24 c, the gasket shapes of face's contact surface is normally trapezoidal.In this respect, the gasket shapes that is arranged in face is conventional leg-of-mutton liner with prior art and compares, an advantage of this trapezoidal shape is that it contributes to realize sealing at some place lower than nose, but also can not stop by the flowing of patient or user nostril (that is to say, in the nose sidepiece cartilage region of the every side of nose and be just below nasal bone).Therefore, liner is placed on the bottom of patient's nasal bridge region.And the contact pressure that described liner was constructed and was placed to nostril region is minimum or eliminates.The shape of liner can change, as: a triangle or other non-trapezoidal character can be employed, and keep it in mind positioning pressure point in nasal bridge region below and avoid stopping up nostril.Some mask pad of the prior art are pushed nostril to, and this has just increased the resistance in air-flow arrival nostril.In a preferred form of described liner, contact surface He Fei face of the face contact surface of liner all has the same conventional trapezoidal shape.

In a kind of form of the present invention, at face's contact area of liner, dispose the combination of a supporting construction and hermetically-sealed construction.The part that supporting construction and hermetically-sealed construction can be used as liner configures, or can select to adopt separated parts.In the situation that supporting construction and hermetically-sealed construction be as the part configuration of liner, described liner can have a solid wall, double wall or three layers or more multi-layered wall construction.In a kind of preferred form of liner, hermetically-sealed construction is provided by thin parts, and supporting construction is provided by a thicker support.

The centre of the bridge of the nose and both sides are especially responsive to contact pressure.Therefore, liner is as far as possible light in the sealing in described region, and this is very important.The unstable of liner may be caused by a pressure that is applied to the increase of nasal bridge region, therefore in described region, has an extra challenge.Support member (for example, the support 200 shown in Figure 24 a) can be designed to avoid completely contact (film 205 as shown in Figure 24 a) with the adjacent part of parts on face's contact surface, therefore allows film 205 to seal separately.Although the anchor point of contact pressure should be avoided in nasal bridge region, especially to avoid being in it contacts with nasal bridge region bottom sensitive spot place, also must keep sealing.Nasal bridge region bottom is usually located at the boniness region of the bridge of the nose to the place of the part conversion of the nose that comprises more cartilages.In addition, be applied to face power should described in be evenly distributed on the whole circumference of liner 40.An aspect of of the present present invention is that face's contact pressure controllably distributes around face.Certainly, for preventing positioning pressure, the power that is applied to nasal bridge region bottom can outwards be disperseed along a wide region of film 25, yet because pressure can be in lip, especially more cosily conciliation of cheek part, so being applied to the power in lip and cheek region can be lighter, if outside extension is considerably beyond the extension at width.And, keeping Liao Yigeyan patient face relatively timely all during pressure distribution, contact area or the width that at contact area or the width of the Mo He of nasal bridge region bottom face, can be greater than film and lip and cheek, this will improve comfortableness.Use described layout, it is equally distributed that patient feels the stress at contact area, even if act on the pressure of contact area, may not be equally distributed.

Another advantage is that liner is the effect that can change and can not affect conversely sealing with respect to patient's angle.For example, the difformity based on patient face, described liner can contact from different patients with different angles, and works as patient in bed, and the angle of described liner can move with respect to the face in moving process.

Sealing member (as film 205) comprises that a large effective winding part (large radius) is to allow motion to a certain degree or mask with respect to the coiling of patient face, and can prevent face and/or nose that the terminal edge of film stimulates patient.Described sealing member (as, film) by the bridge of the nose bottom with nose both sides, be consistent and closely seal with nose.Between the tightness/extensibility of security seal and the film by nose, must reach one compromise.Film otch can be slotted so that extension distance is maximum and there is no an edge tightness.Extensibility also can obtain by material, for example, and soft material and/or thin material, for example, elastomer, silica gel, poly-imido fat, thermoplastic elastomer (TPE), foam and/or synthetic.

Sealing member (as film) preferably has the thickness in 0.1-2.0mm scope, thickness is the elastomer of 0.35mm more preferably, it is easily to stretch that described elastomer allows film on bridge of the nose bottom, the extensibility of film can be different by thickness in different regions, apply stiffening structure as rib, or change with composite construction.

Face's fold is created in the nose pleat place (being considered to nasolabial fold) of the side of face or nose mostly.Basis liner (support as shown in Figure 24 a) is placed on the place near nose side as far as possible.Described like this liner is at the most smooth as far as possible regional seal.Be designed to be placed on face's plication region bending area should described in have a little radius the same as its real radius.Film 205 than the edge of liner (as frame 225) further inwardly or downwards stretch out to allow in nose side along outward flange circle around.This has just reduced to be caused the probability of stimulation and can be prevented that inner liner edge from becoming the stimulus of patient face and/or nose by Roughen Edges.

Through the excess pressure of upper lip may by the design of liner and under self gravitation the vertical direction rotation of mask cause, or cause by being applied to the undesirable pressure on mask, for example,, due to the dilatory of pipeline or be connected in the gravity of the parts on mask.As mentioned above, the design of the headstock can contribute to reduce the undesirable pressure be applied to lip region, and described pressure is that the vertical direction rotation due to mask under self gravitation causes.Lip region 42 can comprise that an otch adapts to the bottom of patient's barrier film, to improve sealing and comfortableness, as shown in Figure 24 g.Barrier film opening 264 should be configured in region 265, as shown in Figure 24 c.Figure 24 a and 24b show the front and back view of liner 40.In an alternative embodiment, a barrier film opening also can be configured on basic liner.

In the present embodiment, liner 40 preferably have one conventional trapezoidal.Yet described liner 40 also can have a non-trapezoidal shape, as a triangle.Described liner 40 comprises a pair of for the cheek region 41 to the sealing of pleat between cheek and nose side is provided; A lip-region 42 for the sealing between providing below patient's nose and above upper lip; With a nasal bridge region 43.Nasal bridge region 43 is across crossing the bottom of the bridge of the nose and the inclined side of the bridge of the nose, and intersects with the nose pleat that is formed on cheek and nose side.Transition between lip region 42 and each cheek region 41 is to start by turn to the place of nasal side around nose bottom at liner 40.Transition between nasal bridge region 43 and each cheek region is at each cheek region 41 fork, to be directed upwards towards the place of the bridge of the nose.In other words, nasal bridge region 43 originates in the place that cheek region starts to be tilted to.Referring to Figure 24 d.

Nasal bridge region 43 is designed to contact with patient's nose, for example, as shown in Figure 1, can find out in the drawings the chosen contact in bridge of the nose bottom.Notice that Fig. 1 shows and support liner 40 separately.Yet, in the accompanying drawing of the U.S. Provisional Application appendix C that is 60/402,509 at the serial number of the Moore introducing etc., show and be connected in two nasal mask assemblies on model nose, to this, will be described below.More particularly, nose comprises the part of the relative boniness in bridge of the nose top, and at supratip flexible cartilage.Must be with reference to Gray ' s Anatomy, the 38th edition (1995), Fig. 6 .133A, B, 6.135A and 11.3A, introduce the figure that shows these regions with as a reference at this.Avoiding along nose boniness district actuating pressure point is that people want to obtain.Conversely, avoiding mask only to contact with the cartilage region of nose is also that people want because its pliability too many undesired movement may be in use provided, may stop up patient's nose path and can not provide one stably fixing.In addition, in nose place location, may increase between the center of gravity of mask assembly of patient face distance-this is also a kind of undesirable consequence.

Therefore, between liner and the bridge of the nose, best sealed engagement region is between the top and cartilage region, bottom in the boniness region of nose.Best, contact area is just on the skeleton above cartilage.Conventionally, liner can be placed on along on the middle skeleton of nose, should avoid the cartilage region of nose side.By the length of nose and other corresponding size, can measure the length from nose to transitional region, or can from the data message of human anatomy, obtain.Provide in Figure 30 and 31 one or more are provided representational size example.Yet under all situations causing in the difference due to individual patient face, liner can not contact with patient at the lower area (being usually located at the boniness region of the bridge of the nose to the place of the nose part transition that contains more cartilages) of the bridge of the nose.

Liner 40 is designed to have one or more of models to adapt to Most patients crowd (as patient crowd's 80%), preferably has a kind of to three kinds of models.The distance at nose bottom and bridge of the nose top is longer than the distance of nose bottom and skeleton and cartilage transition region.Since the length of liner 840 needn't adapt with the whole length of nose, so liner 40 can be made succinct and/or lightweight.Patient's visual field when this optimizes or improve the freedom of liner other parts area and increased mask zone just to designer.Certain face size of optimal mask design has been determined so that the size of population that allows to adapt to maximizes.In one embodiment, a series of color-coded liners are employed.For example described liner can carry out color coding to shape or model.

Figure 24 a-g shows the other view of liner 40.As shown in Figure 24 e, liner 40 comprises support 200 and is connected to the film 205 on support, and support 200 and film 205 for example can a jet film known in the art be moulded in process and formed, as to use with having Shore hardness be 40 SILASTIC ^tMsimilar silica gel.Certainly, support 200 and film 205 also can be formed by two different pieces, and described two different pieces are joined together and/or are connected on support 20.Support 200 has an edge 210, and described edge 210 can be connected on the groove 26 of support 200, as shown in Figure 27 a-29d.Can be by adopting clip, band, friction or pressing, directly film be moulded on support, binding agent and/or the means as known in the art such as glue and groove are connected to the edge of support 200 210 on support 200.Mid portion or the wall 215 of 210 tops, 210He edge, edge have a thickness, and described thickness can bear the tightening force that can apply when liner 40 is placed in the raceway groove bonding station with support.In one form, the thickness of mid portion 215 is 2-10mm, is preferably 5mm.Mid portion 215 210 extends to transition wire 220 from edge, and described transition wire is in thin film 205 and lower bracket 200 junctions and between support 200 and film 205.In a preferred embodiment, the eminence of the mid portion of support 200 is mainly on cheek region 41 and less at lip and nasal bridge region 42,43 places.

Except transition wire 220, support 200 comprises a frame 225.In a preferred form, frame 225 has a curved shape bending downward in liner 40 nasal cavities.In a selective form, framework can be formed by a solid members with conventional circular cross-section.Film 205 has a described part of part 270 (Figure 24 e) that forms sealing and contacts with patient at bridge of the nose lower area, cheek and lip 41-43.Frame 225 has a thickness, and described thickness is preferably less than the mid portion 215 of support 200, but is preferably greater than film 205.For example, film 205, in the thickness range of 0.1-2.0mm, is preferably 0.35mm, and frame 225 has the thickness between 0.5 to 2.0mm, and is preferably 1.35mm.Although preferred film 20 is thinner than frame 225, they also can have identical thickness.Film 205 covers and surrounds the frame 225 of support 200 completely as shown in figure 25.The inner surface of film 205 separates to form and comply with sealing with patient with the outer surface of frame 225.By complying with sealing, this can not apply uncomfortable power with regard to meaning film 205 can adapt to the small difference of patient's face/nose feature, and can guarantee the sealing that mask is in use remained valid with respect to patient's minute movement.Film 205 is preferably at least separated with frame 225 at nasal bridge region 43 places, especially at the 43a place, region (Figure 24 c) that approaches nasal bridge region 43 summits.This is because patient's described region is the most responsive to location contact pressure.Different, film 205 preferably liner 40 contacts with patient and in nasal bridge region 43, to patient, applies unique part of sealing load.Film 205 preferably can apply a lighter pressure along whole nasal bridge region distribution pressure equably, can improve comfortableness thus.Certainly, be applied to the boniness region of nose and the sealing load of cartilage region transition region can not be too large to such an extent as to nostril is partly or entirely sealed.

Frame 225, in nasal bridge region, especially separates enough distances at its place, summit with film 205 and is avoiding its positioning pressure point that is in bridge of the nose bottom or region.And frame 225 should curve inwardly so that substep pressure fifty-fifty, this may cause contacting of film 205 and frame 225.This pressure may be stretch tight the to obtain result of tension or the unsettled result causing due to moving of patient of the headstock.Even if liner 40 is designed to stretch tight to such an extent that also can avoid the contact between frame 225 and film 205 during tension at the headstock.In this case, as long as the structural integrity of liner 40 is not destroyed, frame 225 can be removed to save material and reduce weight at bridge of the nose lower area (at least at 43a place, summit).And frame 225 needn't be crooked along its whole periphery, is especially designed to the position not contacting with film 205.

Interval between cheek and lip-

region

41,42 place's films 205 and frame 225 is unnecessary, thereby but can increase comfortableness and be applicable to wider patient because responsive membrane 205 can make liner 40.

According to liner of the present invention, than the liner of prior art, there is improved stability.The area of coverage, or contact area is maximized, especially along nose side.The limit contact area of liner is maximized.This has two advantages.The first, since the sidewall of liner is longer than some prior art liners according to the present invention, so design a kind of mask locating sealing above nostril and below bridge of the nose top, be possible.The second, by contact pressure being distributed in a larger area of coverage or contact area, just can improve the stability of mask assembly.Like this, when comparing along the mask that roughly an axle in lip top rotates with of the prior art trending towards, the probability that liner 40 rotates in vertical is just less.

Figure 25 d-25i shows the cross section of liner 40.As shown in Figure 25 d, in the scope in the distance between nasal bridge region 43 frames and film at about 5-14mm, be preferably 9mm.As shown in Figure 25 e, the distance between frame and film, in the scope of about 7-16mm, is preferably 11mm.As Figure 25 f, 25g, 25h, 25d and lip-region that 25i is shown in, described distance, within the scope of about 1-6mm, is preferably 4mm.

Figure 25 d-25i shows various other sizes in a preferred embodiment.As, the bending radius of film extending part, angle etc.For example, in Figure 25 d, in the scope in the bending radius of bridge of the nose apex region film at about 5-14mm, be preferably 9mm, and have the angular range of an about 70-90 degree, be preferably 80 degree.As shown in Figure 25 e, bending radius, within the scope of about 4-10mm, is preferably 7mm, and has the angular range of an about 50-70 degree, is preferably 60 degree.Conventionally, the distance of nasal bridge region 43 should described in be greater than the distance in cheek and lip-region 41,42.Can certainly provide a kind of with compound film and the liner of frame, for example, a kind of single layer structure.Conversely, the support function of frame 225 also can be by adopting two or more supporting frames to come support membrane 205 to realize support function, or two or more films are arranged on a frame.In the situation that another kind is selective, the support function of frame and the sealing function of film can be divided into two different parts, and these two different parts can be made from a variety of materials.

Figure 24 e shows film 205 and comprises that a groove 255 preformed, that profile conforms at nasal bridge region 43 places is commonly used to match with the representative profiles of patient's nasal bridge region bottom.Support 200 comprises that one with respect to the groove 260 of groove 255 colocated.Groove 255 is generally a U-shaped shape, and the shape of groove 260 is conventionally wide than groove 255, and groove 260 is also U-shaped shape conventionally.As shown in Figure 24 F, the depth d of groove 255 ₁within the scope of 12-27mm.

As shown in Figure 24 a-c, an inner edge 230 of film 205 forms a hole 235 of film 205.In a preferred form, the shape in described hole 235 is normally trapezoidal, and have a bottom width w who is approximately 31-45mm, have side and a top t that long s is 20-22mm, described top t is conventionally parallel to bottom and has the length of 5-10mm.Referring to Figure 24 c.Angle α in the scope of 45 °-55 °, preferably 50 °.High h between the bottom of film 205 and top is 19-22mm.In addition, the overall length h of liner 40 ₀within the scope of 45-55mm, be preferably 50-51mm, and the overall width w of liner 40 ₀within the scope of 65-75mm, preferred 69-71mm.Equally, as shown in Figure 24 f, the size d of liner ₂within the scope of 29-31mm and pad size d ₃within the scope of 41-43mm.At one, have in the embodiment of liner 40 of " standard model ", the film 205 of liner 40 has a width w who is approximately 31-34mm, is preferably 33mm; A high h within the scope of 19-28mm, is preferably 22mm; And groove 255 has the depth d of a scope between 19-23mm ₁, be preferably 21.5mm.At another, have in the embodiment of liner 40 of " deeply " model, the film 205 of liner 40 has a width w who is approximately 31-34mm, is preferably 33mm; A high h within the scope of 19-28mm, is preferably 22mm; And groove 255 has the depth d of a scope between 22-27mm ₁, be preferably 24mm.Yet in the embodiment of and/or the liner that the degree of depth is more shallow (wide/shallow) wider at another, the film 205 of liner 40 has a width w who is approximately 35-45mm, is preferably 41mm; A high h within the scope of 19-28mm, is preferably 22mm; And groove 255 has the depth d of a scope between 12-20mm ₁, be preferably 16mm.Be understandable that, above-mentioned size has only related to a specific embodiment of the present invention, and the mask of a different model (for example, " little " number with respect to " greatly " number) adopts different sizes also still to fall within the scope of the present invention although shape is identical.In addition, although " standard " type liner, " deeply " type liner, " wide/shallow " type liner can provide separately, these liners also can be used as a set of liner and provide together.This cover comprises that the liner of three models can provide with the good fit of wider patient and can not cause an extra stock.

The limit s of the film 205 adjacent with hole 235 comprises one section of sweep 250 (Figure 24 c), and described sweep 250 is between bridge of the nose part 43 and lip 41.Sweep 250 looks and looks like a ledge that inwardly bends towards hole 235.In Figure 24 f, sweep 250 looks outwards outstanding with respect to adjacent surface.Figure 24 e also shows the degree of depth that is configured in the groove 255 on film 205 in nasal bridge region, and this is from top view.Accompanying drawing 24d provides sweep 250 and film 205 to have another view with respect to the shape of the lower shape of frame 225.Sweep 250 contributes to provide along the side of nose a good sealing, and described side is positioned at the meet seam place at place of cheek and nose.For example, as seen in Figure 24 c, the edge of sweep 250 and frame 225 be separate to realize better at pleat place and along the sealing between nose side.As arrived seen in Figure 24 c, the edge 240 of frame 225 and the edge 230 of film 205 start to be separated from each other with certain angle at cheek 41 places.Distance between the edge 230,240 of film 205 and frame 225 is minimum at lip 42 places.And 41 places increase gradually in cheek region, and in sweep 250 and nasal bridge region 43 maximums, as shown in Figure 25 e-25i.

The inner edge 240 of frame 225 is shown in Figure 24 b, and described inner edge 240 forms a hole 245.The bottom width W in described hole 245 is in the scope of 38-45mm.The long S on every limit is within the scope of 20-23mm.The long T in top is within the scope of 15-20mm, and the high H between bottom and top is within the scope of 32-36mm.Above-mentioned size, and all other sizes that provide at this, are all preferred sizes, and these sizes can change according to specific application certainly.Although the shape in described hole also has a conventional trapezoidal characteristics, yet the hole 235 of described trapezoidal and film 205 trapezoidal has different proportion.Hole 235 is less than hole 245.

In addition, hole 235He hole 245 can have one triangular shaped or other non--trapezoidal shape.In addition, the global shape of liner can be a triangle or a non--trapezoidal shape.The shape of 235He hole 245, hole and liner can be mutually similar or can be different, and for example, hole 235 has a trapezoidal shape hole 245 and has a leg-of-mutton shape.

The width of the film 205 that the edge from transition wire 220 to film 205 records is maximum at sweep 250 and nasal bridge region 43 places, less and minimum at lip-region 42 places at 41 places, cheek region.Film 205 conventionally leaves and extends upward from the transition wire 220 in the bridge of the nose, cheek and lip-region 41-43.At nasal bridge region 43 places, film 205 extends internally so that 230 places end at edge along a conventional continuous radius.In cheek region 41, film 205 is around frame 225 bendings and with certain angle, from frame 225, inwardly point to the bottom of relative support 200 afterwards.At lip-region 41 places, frame 225 and film have essentially identical shape.Referring to Figure 25 d-25i.

Mask support and liner connected system

To carry out in one way the mask in production the present invention, together with this mode will for good and all be connected to each other mask support with mask pad.For example, the place that can be connected as a separate piece at bend pipe, adopts same material that mask support and liner are made to one.Selective, mask support and liner can adopt of the same race or different materials and be formed two parts, and in this selection mode, liner and mask shell couple together in a kind of permanent mode.Permanent connection can by adopting, common film be moulded, binding agent, by clip or other mechanical system, realize.

Selective, mask support can be connected by a kind of method with liner, and described method allows within the service life of mask, repeatedly take apart and connect afterwards again, and this will be described below.This just allows to be taken apart effectively to clean and maintain or even when a part is damaged, bad part can be replaced.

Mask shell of the present invention and liner connected system allow to produce a kind of mask support and liner conjunction, and described conjunction allows to determine liner is connected to the power of support and the power that liner is pulled down from support independently respectively.Due to this performance, produce a kind of power of connection and to take the mask connected system that power is equal apart be possible, or connection power is less than the power of taking apart, or connection power is greater than the power of taking apart and is also all fine.

Described connected system can be designed to obtain one and take power apart, described in the power of taking apart be less than or greater than and when maximum treatment pressure, act on the power in mask system.

The minimum power of taking apart preferably (is for example pulled down the power of liner) and is greater than and when mask intracavity reaches maximum treatment pressure, acts on the power on mask shell and liner conjunction from mask support.By setting, take the minimum of power apart, described minimum is to determine with reference to the power being applied on support and liner conjunction, and when the treatment pressure applying reduces, the probability that mask departs from also can reduce.

Although, minimum take apart power preferably reference treatment pressure applied force determine, the maximum power of taking apart should described in be not more than user be when preventing unexpected landing or pulling down mask with hands when user be worried the power that can cosily apply.Preferably, the power of taking is not more than the power that user can cosily apply.

Can be by adopting sealing of the present invention and holding device to preset and obtain the engaging force (being exactly rightly liner to be connected to needed power on mask shell) of liner.

Preferably, engaging force is not more than the power that user can cosily apply.When the present invention is applied to produce in a large number, maximum engaging force is preferably not more than the power that target end user group energy enough cosily applies.In a clinical instrumentation, target group installs mask the clinical staff that is applied to patient.In non-clinical instrumentation, target group may be end user.Preferably, target engaging force is determined the preferred combination power that can apply when operating mask shell and liner in a kind of mode easily by consideration target group.Certainly, these principles are also applicable to the power of taking apart.

In an embodiment of nasal mask assembly 10, used a kind of improved device namely to keep with sealing device, liner 40 being joined on support 20.Referring to Figure 27 a-29d.There have been maintenance and sealing device, with one, kept the action of liner 40 just liner 40 can be installed on mask support 20 and with support 20 and form a kind of security seal.On the outer wall 30 of the groove 26 on support 20, dispose many recesses 33, these recesses 33 are arranged around outer wall 30 intervals.Recess 33 can pass outer wall 30 partially or completely.The inner surface of inwall 28 and outer wall 30 can be configured to taperedly a little to be easy to a liner 40, be installed on support 20.Liner 40 comprises a sidewall 215.As shown in Figure 25 d, sidewall 215 has the width b of an about 5mm.Sidewall 215 comprises that some keep antelabium 44, and described maintenance antelabium 44 is arranged around sidewall 215 intervals to calibrate with recess 33.Each keeps antelabium 44 to comprise a guide edge 45, and it is tapered to be easy to that liner 40 is inserted to groove 26; Also comprise one and keep surface 431, it is made into can hold recess 33 and can prevent liner 40 and the separated until default separating force of support 20 is applied between liner 40 and support 20.Preferably described default separating force is designed to be greater than liner 40 is inserted to the required power of groove 26.What be positioned at sidewall 215 ends is upper-lower seal antelabium 46 and 47, and they are protruding and extend around sidewall 42 is peripheral from sidewall 215.Relative with seal lip 46 and 47 is upper-lower seal antelabium 49 and 48, and they extend internally from sidewall 215, and extends around sidewall 215 is peripheral.On the opposite that keeps antelabium 44, the inner surface of sidewall 215 has one and is cut down position 50, just between the wall of liner and groove, has formed a space thus, and this just allows the wall of liner 40 flexible to by reduction position 50, as shown in Figure 27 b and 27e, make the insertion of liner 40 easier.Being cut down position 50 just can be arranged at each and keep the opposite of antelabium 44 or along the inner surface of sidewall 215, extend completely.

Now by the assembling of describing according to liner 40 with the support 20 of one embodiment of the present of invention.First liner 40 is aimed at groove 26 conventionally.Referring to Figure 27 a.Inwall 28 slightly higher than outer wall 30 to contribute to liner 40 to aim at respect to groove 26 before entering groove 26.Liner 40 moves to groove 26 afterwards.Referring to Figure 27 b.Each keeps the guide edge 45 of antelabium 44 to be out of shape engaging with a top of outer wall 30 and starting.The position 50 of being cut down of sidewall 215 allows this distortion occur and there is no need to increase significantly power so that liner 40 is inserted in support 20 and is gone.Seal lip 46-49 contacts with the inside and outside wall 28 of groove 26 and 30 surface separately.Liner 40 further inserts in groove 26 until its bottom leans against trench bottom 32.Referring to Figure 27 c.Seal lip 46-49 fully contacts with 30 with the inside and outside wall 28 of groove 26.Each keeps antelabium 44 to enter into recess 33 separately, but still has the distortion of sidewall 215, and described distortion can be cut down position 50 by quilt and be adjusted.When elastomeric compression is released from groove 26, liner 40 is extracted out a little afterwards, keeps the maintenance face 432 of antelabium 44 to rest against on recess 33 separately each, seal lip 46-49 around inside and outside wall 28 and 30 in continuous sealing position.Referring to Figure 27 d.This extraction and seat rely on user provides a liner 40 correctly to rest against the activation signal in groove 26.If it is visual to user that recess 33 is formed in described position, the optical signal that also can provide a seat to lean on.Distortion at described position sidewall 215 has conventionally been eliminated and by reduction position 50, has also been got back to it and loosened structure.For liner 40 is taken apart from support 20, can further from groove 26, extract liner 40 out, will make to keep antelabium 44 to be out of shape downwards.This shape of maintenance antelabium 44 has formed compares the preferred safer power of taking apart with the assembly force of user.

In addition, when the seal lip of liner keep antelabium or both by a kind of silica gel etc. similarly time delay telescopic material make or for example used certain chemically cleaning product when (as at least increased size in a direction), this additional size being caused by the elongation of material or volume can be housed inside in pipeline 26, and this is called seal lip or keeps antelabium deflection.The present invention compared with prior art has superiority in this respect, i.e. the elongation of gasket material can not endanger the sealing of mask shell and liner, and extended the service life of the parts of therefore being produced by this extensible materials.

Prior art typically needs gasket material to obtain closely to seal with support to stop gas to leak from mask chamber by one or more mode.Other mask with an outside or inner clip by padded splint between clip and support.At the Ultra of the ComfortSelect of Respironics mask and ResMed Mirage ^tMin mask, all have this liner clip, these are to have description in 6,412,487 United States Patent (USP) in the patent No., are incorporated herein for your guidance.

For prior art, if liner is made by a kind of material extending in time, this material has a kind of trend at least increasing to a certain extent in a face, and this each increase to a certain degree makes the assembling from mask support groove or pulls down or otherwise use the liner clip difficulty that becomes.Owing to occurring gap between liner hermetic unit and mask support groove, stop the sealing that gas leaks from mask chamber to be endangered.The shortcoming of prior art has been with reference to be described with the sealed groove being positioned on support with the mask that is positioned at the sealing edge on liner with one.Yet similarly shortcoming also can occur in the place that above-mentioned feature configures conversely.That is to say, at sealed groove on liner and sealing the margin on mask shell and be the place of plane at the contact surface of liner and mask shell.

Because the treatment pressure in mask chamber does not have in the process of mask assembling, so the power that the selection of adhesion there is no need to apply in reference treatment process is determined.Be more suitably, to take a kind of like this structure of adhesion that power is little apart be possible to obtain a ratio to produce connected system of the present invention, and wherein the correction data of the engaging force thrust that to be less than the power of taking apart be the pulling force that can apply with any supposition crowd (that is: or two hold an object outwards move from starting point) can apply with them (that is: one or two hold object resemble a fixing point and move) is consistent.

Although if liner is by make such as time delay telescopic material such as silica gel in the situation that, the size of parts can change in time delay, and the embodiment of foregoing description also can keep taking apart the relation that force rate engaging force is large.

Embodiments of the invention have also overcome the shortcoming of forfeiture assembling frictional force of the prior art, in this assembling, have at least parts as liner be to be made by a kind of material that trends towards disappearance in time and lose frictional behaviour, for example use silica gel, this material is due to chemical change or himself absorbing environmental pollutant, as patient's skin oil and fat, and trend towards change " cunning ".But the invention solves between prior art medium-height trestle and liner, As time goes on there is the problem in conjunction with effect disappearance, although the frictional force between them is because the passing of time has been lost.

Although the present invention does not provide the professor who needs band, shelf or other additional holding device, but can comprising aborning, these devices further increase the fastness of combination between support and liner, or can be reduced in addition and obtain take a power required design error consistent with the upper limit, it is suitable that the described upper limit is considered to keep combination for target group when the maximum therapy pressure.

Liner 40 at least comprises a seal lip, and described seal lip plays the effect that stops gas to leak from mask chamber by the contact surface between support and liner.Preferably, as will be descr, at least assemble two seal lip, each has relatively little contact point with respect to support groove 26, to the liner producing in assembling and unpack procedure and the frictional force between support are reduced to minimum and can not damage sealing.

If by a seal lip, so in order to obtain sufficient sealing, its structure may need it to apply all the time in position than the large frictional force of situation of two or more seal lip that adopt same material to make.

By controlling sources of friction, the power that just may affect combination and take apart, for example, by liner and support combination with take required power apart.

The distortion of being cut down the sidewall 215 of position 50 when also can adapt in assembling and taking liner 40 and support 20 apart of sidewall, can reduce thus assembling and take necessary power apart.This is to be even more important while being made by material pliable and tough but that can compress a little such as silica gel etc. at liner 40.Selective, inwall 28 can configure a recess 29 relative with each recess 33 in order to adapt to the distortion of sidewall 215.Referring to Figure 28.Recess 29 (and/or being cut down position 50) can make or be configured to adapt to best the sidewall distortion of expection as desired.The various combination of seal lip 46-49 is available use also.For example can be referring to Figure 29 a (seal lip 47 and 48), Figure 29 b (seal lip 46 and 49), Figure 29 c (seal lip 48 and 49) and Figure 29 d (seal

lip

46 and 47).The structure of other seal lip and maintenance antelabium also can be applied.This structure is by the combination between the sealing function between liner and support and liner and support and keep functional separation, so every aspect is controlled individually and optimizes in can and making at the structure installing.

According to an alternative embodiment of the invention, Figure 32 a-1-32c-2 shows the joint sequency of support 20 and liner.In the present embodiment, sidewall 215 and changing in order to receive the groove of sidewall 215.Figure 32 a-1-32a-2 shows support and the liner before joint, and Figure 32 b-1-32b-2 shows support and the liner in engaging process, and Figure 32 c-1-32c-2 shows support and the liner of abundant joint.

In the present embodiment, sidewall 215 preferably comprises a socket 215a who is integrally formed at the end of sidewall 215.Sidewall 215 comprises that one allows socket 215a to the groove 215b of sidewall 215 bendings.(Figure 32 b-1-32b-2) during insertion, socket 215a is crooked until it is pushed over the protuberance 26a position on groove 26 to groove 215b.After protuberance 26a, socket 215a bending enters in one section of space in the following groove 26 of protuberance 26a.Therefore, the top of socket is placed on elastic locking position, and liner 40 fully and is securely connected with support 20.In connection status, sidewall 215 provide and support 20 between secure seal, can stop the leakage of Compressed Gas from nasal cavity.The top of socket 215a provides one liner is kept to the retentivity being connected with support with the joint of protuberance 26a.In order to take apart, patient pulls out sidewall 215 by a power from groove 26, and described power is enough to cause socket 215a distortion and to overcome protuberance 26a.In conjunction with and take the power that all needs one to be enough to overcome the CONTACT WITH FRICTION between groove 26 and sidewall 215 apart.

In illustrated embodiment, the respiratory cavity that conventionally inwardly stretches into liner at the socket 215a of sidewall 215 ends extends.Yet as described in Figure 32 e, socket 215a is conventionally can be from the respiratory cavity of liner 40 protruding and engage with the outer wall 30 protuberance 26a that are positioned at support 20.

Figure 40-41 show another embodiment of support 20, and support 20 is constructed such that the joint of support 20 and liner 40 is easier.Specifically, the main body 20a of support is included in the collimating marks A on the outer surface of its outer wall 30 ₁, for example, rhombus, line, color, arrow etc.Figure 40 shows the single collimating marks A that is configured in outer wall 30 tops ₁, Figure 41 shows a pair of collimating marks A that is configured in outer wall 30 bottoms ₁.

Liner 40 comprises collimating marks A on its outer surface ₂, for example, rhombus, line, color, arrow etc., described collimating marks A ₂be configured to when liner 40 and support 20 are bonded with each other and be configured in the collimating marks A on support 20 ₁calibration mutually.Figure 38 B, 39B and 42 show the single collimating marks A on liner 40 outer surfaces that are configured in nasal bridge region ₂, Figure 43 shows a pair of collimating marks A on liner 40 outer surfaces that are configured in lip-region ₂.When liner 40 and support 20 are bonded with each other, be configured in the collimating marks A on support 20 tops ₁with the collimating marks A that is configured in liner 40 nasal bridge region ₂aim at.Similarly, be configured in a pair of collimating marks A of support 20 bottoms ₁with a pair of collimating marks A that is configured in liner 40 lip-region ₂aim at.Collimating marks A on support 20 and liner 40 ₁, A ₂calibration respectively, can guarantee mutually correctly to aim at and adjust between support 20 and liner 40.That is to say, by correctly by the collimating marks A on support 20 and liner 40 ₁, A ₂calibration respectively, patient can correctly be bonded together support 20 and liner 40.

Collimating marks A ₁, A ₂can there is suitable structure, for example, rhombus, line, color, arrow etc.Equally, any numbering collimating marks A answering ₁, A ₂can be configured on support 20 and liner 40.In illustrated embodiment, support 20 tops and liner 40 nasal bridge region have different collimating marks numbering A ₁, A ₂, corresponding with support 20 bottoms and liner 40 lip-region.Yet the top and the bottom of

support

20 and 40 nasal bridge region of liner separately and lip-region have identical collimating marks numbering A ₁, A ₂, as long as collimating marks A ₁, A ₂be arranged to make support 20 and liner 40 more easily at correct correct position, to engage.In addition, for making easier combination between support 20 and liner 40, collimating marks A ₁, A ₂can arrange what suitable position in office along the outer surface of support 20 and liner 40.

As shown in figure 40, support 20 can comprise the collimating marks A on side stand assembly 20b ₁, for example, rhombus, line, color, arrow etc., described collimating marks is used for making the joint between support 20 and head frame assembly 80 easier.Specifically, the locking clamp 82 of head frame assembly 80 can comprise the collimating marks on its outer surface, for example, rhombus, line, color, arrow etc., described labelling be configured be for when locking clamp engages one another with support 20 be configured in the collimating marks A on support 20 ₁being aligned is aimed at.

Other side

During a nose liner of design, to consider the shape and size of patient's nose, also will consider the size and dimension of surrounded facial parts, such as upper lip, cheek etc., locate.Referring to Figure 30-31.When about using and need to use patient's the statistical information of size and dimension of certain NPPV treatment seldom time, applicant finds that statistical model that some selected standards can be used for setting up liner 40 for example, to make it to be applicable to most patient group (80% patient crowd).For example, liner 40 can be configured to be applicable to the patient group of 60-90%, no matter the age, sex, or race.Yet for example liner 40 can be configured to applicable more than 70% or more than 80% patient group.According to the width of nose, snout and nose height, apply for into just designing liner, to such an extent as to may need majority, can cosily use the liner/mask of same size in the crowd of nose cup.A kind of or two kinds of other liner/masks can be designed to adapt to the crowd of other parts.Factor when patient's age, race and sex can not become with computer manufacture liner model.And, by designing a liner, in described cushions, can avoid contacting with the top of the bridge of the nose, applicant can eliminate one of them factor of restriction cushion designs conventionally.

As shown in Figure 30 and 31, nose width determines the width in hole on liner 40.Snout has been described the minimum-depth of liner and mask support frame molectron.This is to be measured by the bottom of barrier film.There is the mask of the too large degree of depth can cause in nasal cavity, there is too many idle space, the probability that this will increase that undesirable CO2 resorbs and mask assembly center of gravity further occurs to the situation that moves to reduce stability away from patient's face orientation.Nose height can reflect the width/depth size of device.

Conventionally liner specification meets one or more maximized size.Yet user test is important near space check nostril.If too large, liner may disturb ocular.The below that cushion designs is become to be placed on to the bridge of the nose, the probability of this interference ocular will be reduced.If liner is too little, while exerting pressure along the flexible portion branch of nose as liner, described part may sink, nostril may partly or entirely be blocked and clog, this will cause breathing limited, and this is contingent in some prior aries, as in the simple mask of Respironics.Nose width, height and snout can obtain by reference to anthropometric data table.

In an embodiment of mask system, mask system is designed to comprise that a support can be connected with support with various gasket and every kind of liner.Each liner is configured to accommodate the certain proportion in patient crowd, and various gasket, is preferably 1-3 kind liner and just can be applicable to together the 95-100% in patient crowd like this.

Therefore, but each of various gasket has a similar support contact surface but has different face's contact surfaces.Each liner has at least one face's contact surface parameter, and described parameter is different from all the other liners.In one embodiment, each liner can be different in nasal bridge region.For example, the liner 40a as shown in Figure 38 A-38D has a recess 255a that the shape in nasal bridge region is suitable, and the recess 255b that the shape in nasal bridge region that described recess 255a has than the liner 40b shown in Figure 39 A-39D is suitable is dark.Specifically, recess 255a has a depth d within the scope of 22-27mm, is preferably 24mm, and recess 255b has a depth d within the scope of 19-23mm, is preferably 21.5mm.As shown in the figure, recess 255a has a bending radius less than the bending radius of recess 255b.In another embodiment, the hole of the film of each liner is wide can be different, and various gasket can encode to help to distinguish different liners by color.

The appendix A of the U.S. Provisional Application that the serial number of the Moore introducing etc. is 60/402,509 has comprised the various pictures according to the mask system of a preferred embodiment of the present invention.Appendix A has also comprised the various pictures according to the mask system of an alternative embodiment of the invention.For example, provide the embodiment of a support, described embodiment illustrates the support with oxygen or pressure port.Referring to Figure 41.In support, to be included in application number be in 09/504,234 U.S. Patent application to the further details of oxygen or pressure port, whole being hereby incorporated by wherein.Appendix A has also comprised the tutorial message of mask system.The appendix B of the U.S. Provisional Application that the serial number of the Moore introducing etc. is 60/402,509 comprises the mask of two prior aries that the present invention discussed.The serial number of the Moore introducing etc. is 60/402, the appendix C of 509 U.S. Provisional Application has comprised two figure with the nose of significant difference and the test model of face feature (A+B), has also comprised the mask assembly of the present invention and the prior art mask that are associated with each model.Appendix C also comprised a series of by one embodiment of the present of invention be used in

the comparison diagram that liner of the prior art on mask contrasts.Referring to, as the patent No. of authorizing Kwok etc. is 6,112,746 United States Patent (USP), the document is also incorporated herein by reference at this.As a rule, mask assembly of the present invention all can be consistent with two nose models conventionally, even if size and dimension has significant difference.Liner 40 also can be successfully with Model B in distortion adapt.Mask assembly of the prior art trends towards adapting with the shape of nose model, there will be obvious gap during in particular for this shape compared with spur model.A kind of model of prior art (be referring to the patent No. 5,724,965 United States Patent (USP)) is relative to unsettled and trend towards rotating in the cheek portion at model, especially on less nose model.

Element, parts and characteristic in above-mentioned different embodiment can combine in the mode of any needs or reconfigure and form a new embodiment and can estimate.For example, the present invention has done the description about nasal mask, and these instructions also can be applied in the mask of mouth-nose and whole face.

Claims

1. for carry a respiratory mask assembly for breathable gas to patient, comprising:

The support with main body and side stand assembly, described side stand assembly is arranged on each side of described main body, and each side stand assembly comprises the first connector part, and this first connector is partly integrally formed;

Be detachably connected to the head frame assembly on support, described head frame assembly has the second connector part, and described the second connector is partly suitable for being removably connected with the first connector part being arranged on support;

Wherein, the first connector part and the second connector part have included tooth system separately, the tooth that has tooth system of the first connector part is relative with the tooth that has tooth system of the second connector part, one in the first connector part and the second connector part has magnet, another in the first connector part and the second connector part has metal dish, when the first connector part is connected with the second connector part magnetic and during indented joint partly of tooth partly of the first connector and the second connector, head frame assembly and support are locked and can not rotate.

2. according to the respiratory mask assembly of claim 1, wherein, the first connector partly comprises maintenance structure, and the second connector partly comprises hole, for receiving one of described magnet and described metal dish.

3. according to the respiratory mask assembly of claim 1 or 2, wherein, described magnet consists of neodymium.

4. according to the respiratory mask assembly of claim 1, wherein, the first connector partly comprises a plurality of teeth, and the second connector partly comprises a plurality of teeth that are positioned on a curve.

5. according to the respiratory mask assembly of claim 1, wherein, the first connector partly comprises maintenance structure, and the second connector partly comprises mounting flange and a hole, and the described maintenance structure of the first connector part can be inserted in the described hole of the second connector part vertically.

6. according to the respiratory mask assembly of claim 1, wherein, head frame assembly comprises two front band portions, and before each, band portion also comprises the bar being connected between described front band portion and described support, and described bar comprises described the second connector part.

7. according to the respiratory mask assembly of claim 6, wherein, described bar is arranged on described front band portion.

8. according to the respiratory mask assembly of claim 7, wherein, described bar is arranged on described front band portion by sewing up.

9. according to the respiratory mask assembly of claim 7 or 8, wherein, described front band portion and bar have different pliabilities along first direction and second direction, and described second direction is substantially vertical with first direction.

10. according to the respiratory mask assembly of claim 1, wherein, the first connector part and the second connector partly can greater or less than five different regioselectivities lock.

11. respiratory mask assemblies according to claim 6, wherein, described bar can rotate with respect to described support in the angular range of 50 °-100 °.

12. 1 kinds for carrying the respiratory mask assembly of breathable gas to patient, comprising:

Mask support, comprises left side the first connector part and right side the first connector part, and each in left side the first connector part and right side the first connector part comprises for keeping the maintenance structure of magnet;

Be arranged on the mask pad on mask support;

Head frame assembly, comprise left side second connector part and the right side second connector part with tooth, for being connected to each other with the described left side first connector part of mask support and the tooth of right side the first connector part respectively, each in described left side the second connector part and right side the second connector part has magnet, wherein, once once described left side the second connector part is connected with right side the first connector part magnetic with described left side the first connector part and the described tooth of described left side the first connector part and right side the first connector part and the described indented joint of described left side the second connector part and right side the second connector part with right side the second connector part, the described tooth of the described tooth of described left side the first connector part and right side the first connector part and described left side the second connector part and right side the second connector part just locking left side the second connector part and right side the second connector part and described left side the first connector partly and right side the first connector partly rotate preventing, thereby it can not relative to each other be rotated, wherein, each in described left side the second connector part and right side the second connector part comprises hole, for receiving one of described magnet of described left side the first connector part and right side the first connector part, when described left side the first connector part and right side the first connector part partly engage respectively with described left side the second connector part and right side the second connector, the described magnet of described left side the first connector part and right side the first connector part inserts described hole vertically.

13. respiratory mask assemblies according to claim 12, wherein, the described magnet of described left side the first connector part and right side the first connector part consists of neodymium.

14. respiratory mask assemblies according to claim 12 or 13, wherein, head frame assembly comprises left hole and right ports, each in described left hole and right ports keeps the magnet of corresponding left side the second connector part and right side the second connector part.

15. respiratory mask assemblies according to claim 12, wherein, head frame assembly also comprises the band of being made by laminated fabric or foam.

16. respiratory mask assemblies according to claim 12, wherein, when the described left side of assembling the first connector part, right side the first connector part and described left side the second connector part, right side the second connector part, the respective teeth of the respective teeth of described left side the first connector part, right side the first connector part and described left side the second connector part, right side the second connector part is received in respectively in the groove of corresponding between cog.

17. respiratory mask assemblies according to claim 12, wherein, when described left side the first connector part, right side the first connector part partly engage with described left side the second connector part and right side the second connector, each magnet of described left side the first connector part and right side the first connector part inserts vertically respectively described hole and shifts out from described hole.

18. respiratory mask assemblies according to claim 12, wherein, each magnet of described left side the first connector part and right side the first connector part is columniform.