CN100563746C

CN100563746C - Laryngeal mask and manufacture method thereof

Info

Publication number: CN100563746C
Application number: CNB2004800095985A
Authority: CN
Inventors: L·佩特森; P·霍夫曼恩
Original assignee: ADITECH PHARMA AB
Current assignee: ADITECH PHARMA AB
Priority date: 2003-04-11
Filing date: 2004-04-07
Publication date: 2009-12-02
Anticipated expiration: 2024-04-07
Also published as: CN1771067A

Abstract

The present invention relates to laryngeal mask (1), it comprises at least one airway (2) and cover part (3), this cover part (3) comprises end face (4) and bottom surface (5), described bottom surface (5) comprises the inner chamber (6) that is communicated with pipe (2) inner (7), and described end face (4) comprises closed transition face (8), and described cover part (3) is limited by inflatable big envelope (9) in the bottom surface upper periphery at least, and described cover part (3) comprises the joint that spreads all over contour in big envelope (9) whole, and it is towards inner chamber (6) and be used to the big envelope that provides closed.Thus, provide such product, its cover part and airway part integrally form, and have eliminated this two danger that part is in use separated thus.

Description

Laryngeal mask and manufacture method thereof

The present invention relates to laryngeal mask, it comprises at least one airway and cover part, and described cover partly comprises end face and bottom surface, and described bottom surface comprises the inner chamber with the pipe internal communication, and described end face comprises closed transition face; And wherein the cover part is passed through the inflatable big envelope qualification on the bottom surface at least in its circumference.

In addition, the present invention relates to make the method for laryngeal mask, this laryngeal mask comprises at least one airway and cover part, and described cover partly comprises end face and bottom surface, and described bottom surface comprises the inner chamber with the pipe internal communication, and described end face comprises closed transition face; And wherein the cover part is passed through the inflatable big envelope qualification on the bottom surface at least in its circumference.

EP-1 125 595 has disclosed by roational molding and has made laryngeal mask, and wherein ad hoc, such cover part is made in this process.

Know by blowing mould manufacturing cover part from EP-9 35 971 and EP 922 465.

Laryngeal mask is used to be established to the air duct of respiratory tract, is clogged to the air duct of esophagus simultaneously.Laryngeal mask is shaped so that its such inner cavity surface in the cover part to the larynx opening, and wherein provides inflatable oval-shaped big envelope around this inner chamber, and this big envelope forms the sealing around the larynx opening.Have to this big envelope and to be connected to air bag part and to be connected, and by it, the circumference big envelope of cover is inflated, and guarantees the tight adjacency of this product thus with the piped of valve; Similarly, can carry out the venting of circumference big envelope by deflating via described valve.

Yet the laryngeal mask of prior art is all made with the multi-part product, and air hose and cover part are not integrally to make but with two parts manufacturings that separate of assembling subsequently.Similarly, known such cover is partly made with two parts; That is, to be connected to big envelope part and Connection Element (installation component) each other subsequently.On the one hand, so extra assembling process is expensive, on the other hand, the danger that also exists laryngeal mask to separate in such assembled portion, its may to for example by anesthesia etc. patient cause serious consequence.

Therefore, purpose of the present invention is, an aspect provides laryngeal mask and the method for remedying the problems referred to above, and can provide the product that is configured to single-piece about at least a portion of cover part and airway part thus, thereby eliminated two danger that part is separated in use, and wherein laryngeal mask material thickness variation and can regulate clearly by process.Thus, machinery of Xu Yaoing and elastic characteristic give laryngeal mask what select with clear and definite zone, border.

The laryngeal mask of this purpose by the above-mentioned type realized, and wherein, additionally, the part of airway and cover part are integrally formed with one another at least, so that the overall structure that assembles to be provided, and do not have build-up member between airway and cover part; And wherein cover part comprises and spreads all over contour in big envelope whole and towards the joint of inner chamber, so that closed big envelope to be provided.

This purpose also realizes by the method for the type described at introductory section, and wherein this process is included in injection molding laryngeal mask in the closed mould part, described laryngeal mask comprises at least a portion airway part and cover part, and wherein laryngeal mask discharges from mould, the circumference big envelope of laryngeal mask is included in the opening that extends annularly that wherein points to inner chamber, and this opening is edge limited by upper periphery edge and following circumference.

Thereby, laryngeal mask is made in the mould of closure, wherein, the elastomeric polymer material that is fit to, for example, silicone rubber, PVC, TPE (thermoplastic elastomer (TPE)) (for example SEBS), inject when high pressure, for example initial pressure (when the material that uses is SBBS) and the temperature of material SEBS at about 55MPa is 210 degrees centigrade, and the temperature of closed mould is 50 degrees centigrade, closed mould comprises two mould parts, and it can be from being moved away from each other.Perpendicular to the direction that these mould parts move, two parts that side direction is drawn also are provided, it is triggered subsequently.

Such procedure parameter is the function of the material of selection, and SEBS only is as example.

In addition, this mould comprises at least one core, is used to provide inner chamber and airway part in the big envelope.

After the injected plastic material, laryngeal mask must be emitted from mould subsequently, this is undertaken by following steps, two mould parts are relative to each other removed, and move the part that side direction is drawn perpendicular to its direction that moves subsequently, thus, cause such laryngeal mask now on one and half parts attached to first mould part.Subsequently, this core draws back at the moving direction identical with first movably, and laryngeal mask is fixed on the core segment now.Though the circumference big envelope is around corresponding its core segment, this core can be removed now, because the elastic polymer of circumference big envelope is guaranteed and can accurately be extracted this core out by the opening that extends annularly.

By for example air pressurized being blown between core and the plastic material on every side, laryngeal mask is emitted from mould.The product that comprises cover part and airway part is provided now, and wherein the circumference big envelope has the opening that extends annularly, this opening surface is to inner chamber, this inner chamber constitute cover the bottom and with the pipe internal communication, the described opening that extends annularly has the 1-8 mm distance between perimeter edge and the following perimeter edge thereon.This upper and lower perimeter edge is formed separately and is tongue and recess configurations, and wherein can subsequently this product be arranged in the keeper, apply delegation's glue and tongue is pressed into wherein to groove part, realize the sealing of circumference big envelope thus, thereby change this big envelope into the closed chamber of extending annularly.

It is noted that the joint between upper and lower perimeter edge, also be called the edge boundary, can be to dispose with above-mentioned different mode.For example, can take clear and definite cyclic plane, border below, this plane is suitable for receiving the lower limb boundary; And wherein this edge boundary can be configured to for example have wide edge, and it can be fixed to relative face, for example, and by welding or stickup.It is noted that also that in this interior contour will be understood that being positioned on the bottom surface of big envelope and point to the part of the direction of inner chamber.This big envelope can extend to the end face of cover part, makes end face also comprise big envelope.

By said process, provide product, and wherein double-screw bolt is formed on the circumference big envelope by Unitarily molded subsequently, and in conjunction with molding process, tubule is installed regularly and is communicated with valve and air bag with characteristic of mentioning.Carry out adjusting by this, because can be pressed into air-and can similarly deflate by tubule to the big envelope volume.

Laryngeal mask acts in the following manner, that is, inserting before the patient, and for example Tuo Yuan big envelope is unaerated, promptly shrink, subsequently, when its around the larynx opening obtain correct in abutting connection with the time, carry out and inflate to realize tight connection.Minimum ground, this big envelope be provided on the bottom surface of cover and, as above-mentioned, can randomly on end face, provide big envelope, this big envelope and following big envelope stick together.

By providing according to the present invention, the common wall thickness of the inflatable part of big envelope is less than the common wall thickness of airway, realized in requisition for mechanical property, in the section of selecting, give flexibility and rigidity characteristics that laryngeal mask changes.Thereby, wish that this big envelope is flexible extraordinary, and similarly, wish that any part or the section of this big envelope can inflate manyly than other parts, it is realized by the thin some parts of the section around the wall ratio of this big envelope, simultaneously, wishes that such airway rigidity is better, make it not twist together, and therefore airway can be configured to have thicker material thickness usually.The inflatable part attempt of term refers to those at aeration period, the part that the thickness that approaches with respect to part on every side owing to their stretches.

By providing according to the present invention, the exterior contour of the interior contour of big envelope is oval-shaped, a shape, extension annularly basically, about part, and can randomly be positioned at part on the top of end face, realize the profile easily of this big envelope towards the big envelope of the direction identical with inner chamber.

By providing according to the present invention, the common wall thickness of described end face is less than the common wall thickness of airway and greater than the common wall thickness of big envelope, realized respectively seamlessly transitting between the wall thickness of the thickness of airway and such big envelope.Thereby the wall thickness of end face will be always greater than the wall thickness of inflatable big envelope, and preferably, but not necessarily, its wall thickness is less than airway.

By providing according to the present invention, in big envelope, end face and the airway at least one has the section that wall thickness is greater than or less than the common wall thickness of described cover part, realized the many above-mentioned characteristic of this big envelope, comprise when big envelope inflation in use, the some parts of this big envelope is heaved, and these parts expand manyly than other parts.

By providing according to the present invention, laryngeal mask also is included in the rigid conduit of airway extension, its external jacket that completely or partially is configured to the integral part of airway centers on, realized such rigidity being arranged with the part of covering the air guide channel of partly relatively locating and in use contacting with patient's teeth, make not have the laryngeal mask danger bitten into pieces of airway in use, and similarly eliminated the danger of pipe kink.Rigid conduit can be by plastic material manufacturing easily, for example, inflexible PVC, and similarly, it can be by metal alloy manufacturing easily; Rustless steel for example.Yet, its be preferably with the remainder identical materials manufacturing of laryngeal mask.The position that rigid conduit can be used to be provided at the coupling part (adapter) of the connection between the air source from the common layout on the airway extends to the position that the such cover on the airway partly begins always, and promptly this rigid conduit can have straight route and crooked section.It is noted that this rigid conduit will in use have tapered coupling in attempt easily towards the end away from patient, described adapter is with breathing apparatus or anaesthetize the foundation of air-breathing loop and be communicated with.

By providing according to the present invention, rigid conduit is included in the guide in its surface, has realized giving the flexibility of the increase of rigid conduit, and thus, but this pipeline and airway can be crooked twist together.For example, this groove can be have rib or they can be configured to screw thread.

By providing according to the present invention, airway comprises ribs, ribs and airway constitute whole and with its central shaft bobbin to parallel, the some parts of having realized such airway becomes and has such rigidity, make its danger of in use twisting together reduce, it still keeps flexible simultaneously.This rib can be used for embodiments of the invention, does not wherein use rigid conduit in airway, and perhaps they can be used for the part of the rigid conduit that top teaching is not provided of airway.

More detailed content about laryngeal mask will appear at teaching in the ensuing content:

Can be suitably for this laryngeal mask provide lubricant or Emulsion or antibacterial, on such cover part, thus, this laryngeal mask is more prone to be arranged in patient's the pharynx at least.

In addition, the extra inflatable bellows that is configured as the enlarged of this big envelope can be arranged in the zone of longitudinal axis of big envelope, promptly, basically corresponding airway is connected to the zone of cover, and realized the big envelope of more volume thus, itself will also make it possible to improve adjacency at the rear portion of pharynx.

In addition, this product can comprise two inflatable side direction bellows, and it is arranged on the end face of cover, and is parallel with the longitudinal axis of the main shaft/big envelope of oval-shaped big envelope, and is implemented in the improved sealing that connects between the inner chamber of laryngeal mask and the laryngeal mask opening thus.Thus, provide one group of passage between the end face of side direction bellows and cover part, it allows vomitus to pass through when having any vomitus, can not cause laryngeal mask in the direction displacement away from the larynx opening.

The invention still further relates to the method for making laryngeal mask, and the feature description of the step easily of this method is as follows: the method for making laryngeal mask, this laryngeal mask comprises: at least one airway and cover part, described cover part comprises end face and bottom surface, described bottom surface comprises the inner chamber with the internal communication of airway, and described end face comprises closed transition face; And wherein said cover part is to be limited by the big envelope that can be inflated on the bottom surface in circumference and at least, it is characterized in that described process comprises: injection molding laryngeal mask in the mould part of closure, this laryngeal mask comprise the airway and the cover part of at least a portion; Emit this laryngeal mask from mould, wherein, the circumference big envelope of this laryngeal mask has annularly the opening that extends, and this opening that extends annularly points to inner chamber therein and limited by upper periphery edge and following perimeter edge; And upper periphery edge and following perimeter edge are fitted together with pressing mutually, are used to provide the opening that extends annularly of closure, so that closed big envelope to be provided.

Explain the present invention referring now to accompanying drawing, wherein:

Figure 1A-D is the perspective view of laryngeal mask, and wherein Figure 1A-C shows valve and air bag and is connected to its laryngeal mask, and wherein adapter is installed in the free end of airway;

Fig. 2 A-D shows first exemplary embodiment according to laryngeal mask of the present invention, and wherein scheming A is side view, and figure B is the cutaway view of B-B along the line, and Fig. 2 C is the top view of this product, and to scheme D at last be perspective view;

Fig. 3 A-C shows the alternate exemplary embodiment of laryngeal mask, comprises the cutaway view B of side view A-B-B along the line and the C that sees from above;

Fig. 4 A-D shows the 3rd exemplary embodiment of laryngeal mask, wherein should scheme corresponding basically those embodiment shown in Figure 3, but wherein also shows the perspective view of the product of finishing in Fig. 4 D;

Fig. 5 shows mould part and according to the Move Mode during the manufacturing of laryngeal mask of the present invention;

Fig. 6 shows the perspective view of mould and as the figure of X photography;

Fig. 7 shows according to the present invention and is arranged in on-the-spot laryngeal mask;

Fig. 8 shows the cutaway view according to laryngeal mask of the present invention, and this laryngeal mask comprises ribs in the internal face of air hose;

Fig. 9 is the cutaway view of edge at the middle face of the exemplary embodiment of laryngeal mask shown in Fig. 1 D, and shows the thickness of wall;

Figure 10 is the cutaway view along the middle face of exemplary embodiment shown in Figure 8, and shows the material thickness of wall;

Figure 11 A-C shows the material thickness according to the exemplary embodiment of laryngeal mask of the present invention, wherein schemes the perspective view that A shows this cover, and figure B shows the laryngeal mask of seeing from above, and figure C shows the cover of seeing at cross section C-C from figure B;

Figure 12 A-D shows the multi-part laryngeal mask, and wherein scheming A is side view, and figure B is the cutaway view of B-B along the line, and figure C is the top view of this product, and to scheme D at last be perspective view; And

Figure 13 A-D shows the embodiment of multi-part laryngeal mask shown in Figure 12, and wherein scheming A is side view, and figure B is the cutaway view that B-B along the line sees, figure C is the top view of this product, and to scheme D at last be perspective view.

Figure 1A-D shows the exemplary embodiment of laryngeal mask 1, and laryngeal mask 1 comprises at least one airway with circular cross-section 2 and cover part 3, and described cover part 3 comprises end face 4 and bottom surface 5.Bottom surface 5 comprises and pipe 2 inner 7 inner chambers that are communicated with 6.End face 4 comprises closed, is preferably level and smooth transition face 8.This face 8 be preferably the projection and its can also be included in its outside or inner face on ribs.Cover part 3 limits by inflatable big envelope 9 at circumference.Its exterior contour can be for dripping shape, and is oval-shaped, avette, or the like.Airway 2 and cover part 3 are integrally forming inside each other, so that the product of the integral body that assembles to be provided, do not have Connection Element between airway 2 and cover part 3.

The manufacturing of this laryngeal mask is undertaken by injection molded process, and laryngeal mask is by the polymer material manufacturing.For circumference big envelope 9 provides double-screw bolt 21, double-screw bolt 21 is connected to another pipe 18, and it is thinner than airway 2, and at its free end valve 20 and air bag 19 is installed.By this, the inflation of circumference big envelope 9 and venting are carried out according to known principle.Second pipe 18 can be fixed to the outside of airway 2 easily along airway 2, relate at least in initial 1-5 centimetre that begins from double-screw bolt 21.This can for example realize in the following manner: airway is equipped with the rib (not shown) of recess or longitudinal extension, and second pipe 18 can be pressed into and selectively be attached to wherein.

Figure 1A-D shows the laryngeal mask at the state of its inflation, and wherein, if circumference big envelope 9 has passed through valve 20 deaerations, circumference big envelope 9 shrinks.

Figure 1A shows such situation, and wherein, tapered coupling 115 is at the free end of airway 2-promptly relative with the end of having located cover part 3-mounted thereto, and this adapter 115 has been set up the connection of arriving breathing apparatus or anesthesiaing system.

Figure 1B and difference shown in Figure 1 are, it also comprises rigid conduit 114, rigid conduit 114 is a straight hollow pipe, it is by plastic material, for example rigid PVC manufacturing, yet it also can be by the metal manufacturing, and extends into tapered coupling 115 at its free end, and this rigid conduit 114 and adapter 115 can be integrally molded.The part that does not comprise adapter 115 of rigid conduit 114 is centered on by external jacket 117, its formation and be configured as the part of the integral body of airway 2.Airway 2 is crooked, and its inner chamber 7 is communicated with the inner chamber 114 of rigid conduit.Rigid conduit 114 can dispose in many ways.For example, it can be for undulatory, and similarly, in requisition for the bendability of pipeline, it can have guide, screw thread and analog.In the example that illustrates, this pipeline is slick.

It is noted that minimum ground, airway 2 comprises crooked part and straight part.Crooked part constitutes the part of the integral body of laryngeal mask usually.

Laryngeal mask shown in the substantially similar Figure 1B of laryngeal mask shown in Fig. 1 C; Yet the difference of laryngeal mask shown in itself and Figure 1B is, in this case, airway 2 shorten and therefore its fully around rigid conduit 114.Yet, it is noted that rigid conduit 114 can be configured so that very suitably that it also comprises crooked part, the part of the bending of corresponding airway 2.Yet Fig. 1 C shows, outside approximately half of rigid conduit 114 is exposed to.Should be noted that, airway 2 is so tight around the outer surface of rigid conduit 114, makes to there is no need between the interior scope of freedom of the outer surface of rigid conduit 114 and airway 2, to have fabricated material, yet, traditionally, can between connector part and such airway, use glue.In addition, Figure 1B, 1C and Fig. 1 D show, and big envelope 9 comprises down big envelope part 10 and upper envelope part 11, and this upper envelope part 11 is positioned at that airway extends into cover part 3 places on the face 4.

According to preferred embodiment, airway 2 and cover part 3 are molded by the material that can be attached to the material that is used for rigid conduit 114 around rigid conduit 114.Thus, therefore in fact integrally molded and when causing thus constituting the unit of an integral body when rigid conduit 114, airway 2 and cover part 3, realized connecting very closely.In a preferred embodiment, rigid conduit 114 is by molded with airway 2 identical materials.

Fig. 2 A-D shows first exemplary embodiment of laryngeal mask, and the laryngeal mask shown in the corresponding diagram 3A-C basically, and its difference is that laryngeal mask 1 does not comprise upper envelope part 11.Exemplary embodiment shown in Fig. 2 A-D is the laryngeal mask shown in the corresponding diagram 4A-D basically also, and its difference is that this laryngeal mask does not comprise inflatable side direction bellows 12.

Therefore, the difference shown in profile shown in Fig. 2 B and Fig. 3 B is, big envelope 9 unique big envelope parts 10 down that comprise, and following big envelope part 10 is extended with unbroken ring around the whole circumference contour of inner chamber 6.In drawing, laryngeal mask illustrated with the interstage, and wherein laryngeal mask also is not fully assembled, and upper periphery edge 14 and following perimeter edge 15 must be assembled, so that big envelope part 10 constitutes the closed big envelope 9 that extends annularly down.Following big envelope part 10 is basically about its longitudinal axis symmetry, and is still asymmetric about minor axis.Therefore, it is oval that big envelope part 10 is generally, as understanding by research Fig. 2 C.Therefore,

big envelope

9,10 does not extend to embodiment illustrated in fig. 2 top 4.

Fig. 3 B is the cutaway view along the B-B among Fig. 3 A, and another exemplary embodiment of this laryngeal mask is included in the circumference opening 13 towards inner chamber 6 that extends annularly in the interior circumference of big envelope 9.Therefore, before the oval big envelope 9 that produces closure, what see is the laryngeal mask in interstage.This opening limits by upper periphery edge 14 and following perimeter edge 15.Before big envelope 9 assemblings, between them the gap between 1 to 8 millimeter.The interior circumference of the closure of cover part is produced by upper periphery edge 14 and following perimeter edge 15, is configured to for example tongue 16 and groove 17 structures, is also known as sun/the moon structure, subsequently in abutting connection with the ground assembling, for example, by taping process, so that closed gastight circumference big envelope 9 to be provided.These two

perimeter edge

14,15 can have other shape and can otherwise assemble, for example by welding.

Such airway 2 can comprise one or more sensing indicator pearls 10, is included in the projection on pipe 2 the outside.They selectively specific placement on the part of airway, and can be used as and help the operator to arrange laryngeal mask 1.Therefore, sensing indicator pearl 10 allowed to determine that this covers on intraoral position to sense of touch between 1 introduction period of cover.Certainly, this sensing indicator pearl 10 also can be used for the alternate embodiment of laryngeal mask 1.

The cover part 3 of laryngeal mask can comprise on the end face 4 that is arranged in the cover part or constitute the extra inflatable bellows or the upper envelope part 11 of the part of the integral body of covering end face 4 partly.This bellows 11 can provide by pasting extra plastic film chip, and this plastic film chip is fixed to the end face of circumference big envelope, but it preferably provides with the form of the part of the expansion of big envelope 9, and thus, big envelope 9 comprises upper envelope part 11 and following big envelope part 10.Alternatively, bellows 11 can be configured to, and in such cover, forms other chamber, and when 9 inflations of circumference big envelope, this other chamber is full of air.Its purpose is for guaranteeing that between 1 operating period of cover more closely in abutting connection with centering on the larynx opening, bellows 11 abuts against on the wall of the pharynx relative with the larynx opening cover part 3.

Fig. 4 A-D shows the 3rd exemplary embodiment according to laryngeal mask of the present invention, and the exemplary embodiment with shown in Figure 2 is identical basically, but the circumference big envelope 9 that wherein covers part 3 comprises at least two inflatable side direction bellows 12, it is arranged on the end face 4 of cover, and parallel with the main shaft of common oval big envelope 9 basically.Same as described above, it can be used as guaranteed between 1 operating period of cover, and more closely in abutting connection with centering on the larynx opening, side direction bellows 12 abuts against on the wall of the pharynx relative with the larynx opening cover part 3.Form passage 4 at side direction bellows 12 with between above the cover part 3 simultaneously, it allows vomitus by the cover part when having any vomitus.Thus, if when having any vomitus, prevent the some parts of vomitus displacement cover part 3 or cover part 3.

In addition, all or part of of cover 1 can apply lubricant, thereby makes its more easy arrangement.Such reagent is known from for example conduit, and wherein lubricant for example activates by moistening.This coating is that product adds water-wet behavior, causes its bound water when moistening.An example of coating agent is that the PVP-polyvinylpyrrolidone-it also covers 1 antibacterial characteristics.Other coating provides water-wetted surface specially.

The manufacture process of laryngeal mask 1 has been shown in Fig. 5-6, and has carried out with the injection molded process in the close die part 101, this laryngeal mask 1 comprises airway part 2 and cover part 3, and wherein, and after molded, cover 1 is emitted from mould.In the interstage, the circumference big envelope 9 of laryngeal mask 1 comprises the opening 13 that extends annularly, and limits by upper periphery edge 14 and following perimeter edge 15.Opening 13 is towards the inner chamber 6 of cover part 3, and opening 13 is guaranteed and can be discharged cover from mould.After laryngeal mask 1 discharged from mould, the distance between upper periphery edge 14 and following perimeter edge 15 was the 1-8 millimeter.

The liquid plastics material injects closed mould 101 at first pressure and first temperature.Mould 101 comprises at least one core 102, and core 102 provides the inside

inner chamber

7,6 in pipe 2 and cover 3 parts.

Mould 101 also comprises two first mould parts: top first mould part 104 and bottom first mould part 105, its interface 106 comprise that 107, the first interfaces 107, first interface are positioned in following 5 the zone of corresponding cover.These two mould parts can move perpendicular to interface 107 each other.Interface in the zone of molded tube part is regional consistent with its diameter maximum.

Mould 101 also comprises two second other mould parts 108, and their other Move Mode is perpendicular to the portable cord of first mould part.

When plastic material injects mould 101, and during laryngeal mask 1 molded finishing, it must be removed.Bottom first mould part 105 is removed from upper die part 104, and by using second Move Mode, these two second mould parts 108 are moved away from each other.

Subsequently, core 102 moves in the direction identical with bottom first mould part 105, and laryngeal mask 1 discharges from mould.As mentioned previously, this realizes that by the opening that extends annularly 13 that is provided in the circumference big envelope 9 circumference of cover part 3 comprises upper and lower 14 circumferences, with for example tongue/

recess configurations

16,17 configurations.They are for assembling each other to finish laryngeal mask 1, for example, by taping process so that the circumference big envelope 9 of basic closure to be provided.

In addition, core 102 can comprise two core segments that can move each other, and wherein, a core segment provides big envelope 9, and another core segment participates in providing the remainder of laryngeal mask 1 simultaneously.

Subsequently on circumference big envelope 9 for laryngeal mask 1 provides pipe 18, provide valve 20 and guiding air bag 19 at the free end of described pipe 18.This carries out according to known principle and makes it possible to the inflation of circumference big envelope and in the use final vacuum.According to known principle, adapter 115 is made together with rigid conduit 114, and perhaps adapter 115 can be gone up at the free end (far-end) of airway 2 and insert.As the function of the size of laryngeal mask, it can be fabricated to shades of colour, and after this manner, the operator can recognize the different size of laryngeal mask more easily.

Fig. 7 shows laryngeal mask at the scene.As understanding by this figure of research, cover part 3 is arranged as adjacency around the larynx opening, and the big envelope of inflation is guaranteed this adjacency.Airway 2 extends through pharynx and its free end can be connected to for example breathing apparatus.Similarly show second pipe 18 that extends through pharynx.Therefore, second pipe 18 is used to inflate closed big envelope 9.

Fig. 8 shows according to the exemplary embodiment of laryngeal mask 1 of the present invention and shows in cutaway view.As shown in the figure, provide ribs 22 at freedom, the far-end of airway 2, ribs 22 is parallel to the vertical axis extension of airway 2 and is positioned on the face of inner chamber 7.The result of increase material thickness that rib 22 can be used as some sections of airway 2 occurs.

These ribs 22 give enhanced rigidity in this zone, and help to prevent to manage 2 kinks.In addition, the cover part 3 section 23 in-particularly above the circumference big envelope 9 foremost-will occur the thickening material thickness with the realization compare with common big envelope 9, the thickness 23 of this front presents enhanced rigidity.Guarantee to have improved product thus and import patient, because such rigidity prevents to cover this section bending or folding in the process of laryngeal mask 1 importing patient's pharynx of part 3.

Also shown is the tangible curvature between cover part 3 and airway 2, form 60-90 degree angle between the longitudinal axis of the longitudinal axis of airway 2 and cover part 3.

It is noted that in that injection molding makes it possible to regulate the material thickness of laryngeal mask 1 as one of the advantage of its uniqueness, can present the material thickness littler than other section/part so that realize some sections of laryngeal mask 1 or part.

Thus, can regulate the flexibility and the rigidity of laryngeal mask 1, as indicated in the details of the configuration by above-mentioned reinforcement 23 about ribs 22 and front.

In the same manner, suffer the little material thickness in the zone of pressure influence, promptly typical circumference big envelope 9 will expand in these zones,, be inflated to thicker regional big size that is, and the formation projection, this projection only in conjunction with described inflation the time as seen.Therefore, when not inflating, laryngeal mask 1 will occur with uniform surface.This characteristic is used in conjunction with the extra inflatable bellows 11 and the inflatable side direction bellows 12 of this product.

At last, it is noted that airway 2 can comprise liner 114.Can provide this liner 114 by carrying out following steps, at first execution first is molded in the first plastics material of first airway 114, and subsequently second plastic material is injected in the closed mould, and, and be used to provide aforesaid whole laryngeal mask 1 around the outside of first airway 114.First and second plastic materials do not need to be bonded to each other.Compare with such laryngeal mask 1 with other section of airway 2, this other liner 114 in airway 2 gives airway 2 other mechanical properties in those sections, for example, and the rigidity of increase.As mentioned above, this extra liner 114 can comprise rigid conduit 114.

Fig. 9 A is the cutaway view along the middle face of product shown in Fig. 1 D, wherein shows the thickness of wall.In an example shown, airway 2 has the wall thickness that is included in second interval 112, and corresponding 1.4-3 millimeter, is preferably the 1.5-3 millimeter, and the wall thickness of airway 2 changes in this interval c, d.Such big envelope 9 has the wall thickness that is included in first interval 111, has lower limit a and higher limit b, the described first interval 111 common corresponding 0.4-0.8 millimeters.Should be noted that in this, those are located directly contiguously and can have less thickness around the part of the big envelope 9 of the inner chamber 6 of cover part 3, and other section/part of big envelope 9, section/the part of the upper wall 118 of those corresponding big envelopes 9 for example, can very suitably have bigger wall thickness, in the case more inessentially, at big envelope 9 aeration periods, big envelope 9 can expand.In the

transition portion

4,8 between big envelope 9 and airway 2, thickness can be preferably the interval at the 0.5-3 millimeter in the 3rd interval 113.

Shown in Figure 10 identical with Fig. 9 basically, but wherein ribs 22 is arranged in the airway 2, and extending from certain distance that limits the edge from upper area, and the whole direct route of corresponding basically airway 2, these ribs 22 are taked 2.5-3 millimeter wall thickness, therefore and guarantee that airway 2 do not twist together, and in the same manner, it has strengthened the mechanical property of that part of laryngeal mask.

The other parts of the wall of laryngeal mask 1 have basically and identical size shown in Figure 9.In addition, it is noted that the higher limit in the 3rd interval 113 and lower limit for making lower limit, and the upper limit is less than or equal to the d value greater than a value.In addition, in those situations, when liner/rigid conduit 114 is arranged in the laryngeal mask, wall thickness will present little size in those sections 117 of the covering liner/rigid conduit of airway 2.In this case, airway 2 will have such characteristic usually, the promptly general similar pipe box that is positioned at rigid conduit outer surface outside.In those situations, the thickness of the airway in those zones can be about 1.5 millimeters.

Figure 12 shows the exemplary embodiment according to laryngeal mask of the present invention.The figure shows the common wall thickness of the different piece of laryngeal mask 1.As shown in the figure, this big envelope has another the common wall thickness T 1 that is included in described first interval 111, airway 2 has another the common wall thickness T 4 that is included in described second interval 112, and

transition portion

4,8 has the common wall thickness T 3 that is positioned at above-mentioned the 3rd interval 113.

The wall thickness that term used herein " common wall thickness " attempt refers to the relevant part of laryngeal mask 1 is the specific wall thickness for the most of section in these parts substantially, though the section of relevant part can have the wall thickness of the wall thickness that is not common.

As shown in figure 12, this can relate to for example section 23 of big envelope 9, and it has wall thickness T 2, and wall thickness T 2 is greater than other wall thickness T 1 of this big envelope.Reinforcement as above-mentioned prevents the front end kink of big envelope or folding during laryngeal mask 1 imports in patient's the pharynx.The common wall thickness 1 of the inflatable part of big envelope is preferably 0.4 millimeter, and according to the size of laryngeal mask, the wall thickness T 2 of strengthening section 23 is preferably the 1-2 millimeter.

Figure 12 also shows can provide rib for the part of the bending of air hose 2, with the rigidity of that part of increasing pipe 2.These ribs have wall thickness T 5, and wall thickness T 5 surpasses the common wall thickness T 4 of airway 2.According to the size of laryngeal mask, T5 is preferably the 2.2-4.8 millimeter.

Preferably, laryngeal mask is configured so that the common wall thickness T 1 of inflatable part of big envelope 9 is than the common wall thickness T 4 of airway 2.The common wall thickness T 3 of transition zone/

end face

8,4 is less than the common wall thickness T 4 of airway 2 and greater than the common wall thickness T 1 of the inflatable part of big envelope 9.

Also should further mention, airway can have transparent zone, can see in airway inside thus water vapour occurring, and its indication is breathed and carried out.This can combine with manufacture process and provide, wherein, for example this core can sand milling giving its coarse surface, but wherein this core is perfectly smooth in the zone of selecting, and means that laryngeal mask 1 corresponding zone on cover 1 will be more transparent.Coarse surface on core means that also this product can more easily emit from mould.These provide the zone of the window of some types to be configured to thickness usually in airway is about 0.5 millimeter.It is the thickness of the wall thickness of about corresponding ring-type/oval inflatable big envelope 9.

The rigid conduit 114 that does not present the flexibility of any kind also can be configured to have window in the position of selecting, and it makes it possible to visually detect the appearance of any water vapour.

At last, it is noted that such laryngeal mask 1 can be configured to multiple color, perhaps the some parts of this product can be provided as different colors, makes user recognize that easily the cover 1 of what size in physical location is relevant, depends on promptly what size patient needs.Therefore, yellow color can a corresponding size for a patient, and blue color can corresponding another size.This especially promotes the management role of Hospital Authority, and in the same manner, it can guarantee not make a mistake in distribution procedure.

The invention still further relates to laryngeal mask 1 ', laryngeal mask 1 ' comprises at least one airway 2 ' and cover part 3 ', described cover part 3 ' comprises end face 4 ' and bottom surface 5 ', this bottom surface 5 ' comprises and the airway 2 ' inner 7 ' inner chamber 6 ' that is communicated with, and this end face 4 ' comprises closed transition face 8 ', described cover part 3 ' is limited by inflatable big envelope 9 ' on the circumference of bottom surface 5 ' at least, the big envelope 9 ' of described cover part 3 ' comprises inflatable device, be used in abutting connection with wall against the pharynx relative with the larynx opening, to provide the cover part to be connected with the tight of larynx opening, and wherein, between the end face 4 ' of these abutment means and cover part, provide passage.

These devices comprise at least two inflatable side direction bellows 12 ', and it is arranged on the end face of cover big envelope 9 ', and are arranged as basically the longitudinal axis symmetry about big envelope (9 ').

Inflatable side direction bellows (12) is arranged on the end face (4) of cover 1, and arranges parallelly with the longitudinal axis of big envelope 9 ' basically.

Figure 12 shows the exemplary embodiment of such laryngeal mask 1 '.

After opening big envelope 9 ', these side direction bellows 12 ' can press the rear wall of the pharynx relative with the larynx opening, and increase the abutment pressure of cover big envelope 9 ' against the pharynx that centers on the larynx opening thus.Configuration by preferred side direction bellows 12 ', can be implemented under the situation of patient's pressure breathing, the compactness of cover 1 increases under the situation of high scavenge pressure, and be formed on the clear passage that the end face 4 ' that passes cover between the inflatable side direction bellows 12 ' arrives the oral cavity simultaneously, as understanding by comparison diagram 7 to Figure 12 from esophagus.Thus, laryngeal mask 1 allows any vomitus can pass through laryngeal mask 1 ', and guarantees that such vomitus can not penetrate between larynx opening and the laryngeal mask 1 ', and laryngeal mask 1 ' perhaps is shifted.Thus, prevent patient's respiratory tract obturation.

Therefore, compare with known laryngeal mask, the present invention provides laryngeal mask 1,1 ' in simple mode, it is characterized by the compactness of the increase under the situation of high scavenge pressure, and provides between the rear wall of the end face of cover and pharynx simultaneously and be used for the leakage path that gastric content passes through.This leakage path also allows to insert stomach tube, is used for aspirating after importing, and is laryngeal mask 1,1 ' inflation.

The compactness that under the situation of high scavenge pressure, increases of Huo Deing and provide the combination of the opening leakage path of the end face that passes laryngeal mask to make laryngeal mask 1,1 ' according to the present invention be very suitable for being used to suffer from the patient that acute respiration stops like this, because when treating such patient, vomiting is relevant to high scavenge pressure with gastric content.

As mentioned above, the side direction bellows also can be used for the laryngeal mask 1 of unitary, injection-molded, has wherein realized identical advantage.Be used for realizing that by laryngeal mask the prior art of these characteristics is in ensuing patent and application description individually, yet, they all relate to the shortcoming of comparing with the present invention: US 5,355,879 and US 5,871,012 have described cover, and this cover has the device that is used for increasing compactness under the situation of high scavenge pressure; US 5,241,956 and US 6,439,232 cover that discharge conduit is provided has been described.

According to embodiments of the invention, side direction bellows 12 ' can, as shown in figure 13, be fabricated to feasiblely, before inflation, they are towards the direction that enters inflatable big envelope 9 '.This will promote the layout of laryngeal mask 1 '.After big envelope 9 ' inflation, therefore the side direction bellows will present shape as shown in figure 12.This embodiment can also suitably be used for laryngeal mask 1.

List of reference numbers:

Laryngeal mask: 1

Wireway: 2

Cover part: 3

End face: 4

Bottom surface: 5

Inner chamber: 6

Pipe is inner: 7

Closing face: 8

Oval big envelope: 9

Indicator pearl: 10

Extra inflatable bellows: 11

Two inflatable side direction bellows: 12

The opening that extends annularly in oval big envelope: 13

Upper periphery edge: 14

Following perimeter edge: 15

Tongue: 16

Groove: 17

Pipe: 18

Valve: 19

Guiding air bag: 20

Double-screw bolt: 21

Ribs: 22

The reinforcement of front: 23

Mould: 101

Core: 102

Top first mould part: 104

Bottom first mould part: 105

Interface: 106

First interface: 107

Second mould part: 108

Edge boundary: 110

First interval: 111

Second interval: 112

The 3rd interval: 113

Rigid conduit: 114

Adapter: 115

Inducing QI tube wall: 116

External jacket: 117

Claims

1. a laryngeal mask (1), it comprises:

-at least one airway (2); And

-cover part (3),

Described cover part (3) comprises end face (4) and bottom surface (5), described bottom surface (5) comprises the inner chamber (6) that is communicated with the inside (7) of airway (2), described end face (4) comprises closed transition face (8), described cover part (3) is limited by inflatable big envelope (9) on the circumference of bottom surface (5) at least, and described cover part (3) comprises and spreads all over contour in big envelope (9) whole and towards the joint of inner chamber (6), with the big envelope (9) that is used to provide closed, it is characterized in that, at least a portion of described airway (2), described cover part (3) and described inflatable big envelope (9) are that integral body is made mutually, so that the overall structure of assembling to be provided, and in described airway (2), there is not assembly element between described cover part (3) and the described inflatable big envelope (9).

2. laryngeal mask according to claim 1 is characterized in that, the common wall thickness of the inflatable part of big envelope is less than the common wall thickness of airway (2).

3. laryngeal mask according to claim 2, it is characterized in that, the wall thickness of the inflatable part of big envelope is included in first interval (111) of the closure with lower limit a and higher limit b, and the wall thickness of airway (2) is included in second interval of the closure with lower limit c and higher limit d, and the higher limit d in second interval surpasses the higher limit b in first interval (111).

4. according to any one the described laryngeal mask in the claim 1,2 or 3, it is characterized in that the exterior contour of the interior contour of big envelope (9) is oval-shaped, a shape, extension annularly basically.

5. according to any one the described laryngeal mask in the claim 1 to 3, it is characterized in that the common wall thickness of described end face (4) is less than the common wall thickness T 4 of airway (2), and greater than the common wall thickness of big envelope (9).

6. laryngeal mask according to claim 3 is characterized in that, the wall thickness of described end face (4) is included in the 3rd interval of lower limit greater than the lower limit a of first interval (111).

7. according to any one the described laryngeal mask in the claim 1 to 3, it is characterized in that at least one in big envelope (9), end face (4) and the airway (2) has the section that wall thickness is greater than or less than the common wall thickness of described cover part.

8. laryngeal mask according to claim 3 is characterized in that, the wall thickness of the inflatable part of big envelope (9) presents the material thickness that is included in the variation in first interval (111).

9. according to any one the described laryngeal mask in the claim 1 to 3, it is characterized in that, this laryngeal mask also is included in the rigid conduit (114) of airway (2) extension, and its external jacket (117) that completely or partially is configured to the integral part of airway (2) centers on.

10. laryngeal mask according to claim 9 is characterized in that, rigid conduit (114) is included in the guide in its surface.

11. any one the described laryngeal mask according in the claim 1 to 3 is characterized in that airway (2) comprises ribs (22), ribs (22) and airway (2) constitute whole and with its central shaft bobbin to parallel.

12. any one the described laryngeal mask according in the claim 1 to 3 is characterized in that, this laryngeal mask is with the injection molded process manufacturing, and by the elastomeric polymer material manufacture.

13. any one the described laryngeal mask according in the claim 1 to 3 is characterized in that, airway (2) comprises at least one sensing indicator pearl (10), and sensing indicator pearl is included in the rib on the outside of airway (2).

14. according to any one the described laryngeal mask in the claim 1 to 3, it is characterized in that, cover part (3) comprises a bellows that can be inflated (11), and the bellows that can be inflated (11) is arranged in the integral part that cover end face (4) was partly gone up or constituted to the end face (4) that covers part (3).

15. according to any one the described laryngeal mask in the claim 1 to 3, it is characterized in that, the big envelope (9) of cover part (3) comprises at least two side direction bellows (12) that can be inflated, and it is arranged on the end face (4) of cover, and parallel with the longitudinal axis of big envelope basically.

16. any one the described laryngeal mask according in the claim 1 to 3 is characterized in that, cover part (3) is coated with lubricant and/or antibacterial at least.

17. any one the described laryngeal mask according in the claim 1 to 3 is characterized in that, closed transition face (8) comprises ribs.

18. any one the described laryngeal mask (1) according among the claim 1-3 is characterized in that, big envelope (9) is included in the section (23) of top reinforcement on the end face of big envelope (9).

19. laryngeal mask according to claim 1 is characterized in that, the big envelope (9 ') that is inflated of cover part (3 ') comprises the device that can be inflated, and is used in abutting connection with the wall against the pharynx relative with the larynx opening, is connected with the tight of larynx opening so that the cover part to be provided; And between the end face (4 ') of device that can be inflated and cover part, form passage.

20. laryngeal mask according to claim 19, it is characterized in that, the big envelope (9 ') that is inflated of cover part (3 ') comprises at least two side direction bellows (12 ') that can be inflated, and it is arranged on end face (4 ') of cover (1 ') and about the longitudinal axis symmetry of big envelope (9 ').

21. a method of making laryngeal mask (1),

This laryngeal mask (1) comprising: at least one airway (2) and cover part (3), described cover part (3) comprises end face (4) and bottom surface (5), described bottom surface (5) comprises the inner chamber (6) that is communicated with the inside (7) of airway (2), and described end face (4) comprises closed transition face (8); And wherein said cover part (3) is that (5) are upward limited by the big envelope that can be inflated (9) in the bottom surface in circumference and at least,

It is characterized in that described process comprises:

Injection molding laryngeal mask (1) in the mould part (101) of closure, this laryngeal mask (1) comprise the airway (2) and the cover part (3) of at least a portion;

From mould (101), emit this laryngeal mask (1), wherein, the circumference big envelope (9) of this laryngeal mask (1) has annularly the opening (13) that extends, and this opening that extends annularly (13) points to inner chamber (6) therein and limited by upper periphery edge (14) and following perimeter edge (15); And upper periphery edge (14) and following perimeter edge (15) are fitted together with pressing mutually, are used to provide the opening (13) that extends annularly of closure, so that closed big envelope (9) to be provided.

22. method according to claim 21 is characterized in that, the distance between upper periphery edge (14) and following perimeter edge (15) is the 1-8 millimeter.

23., it is characterized in that according to claim 21 or 22 described methods:

-liquid polymeric body material injects closed mould (101) at first pressure and first temperature, wherein mould (101) comprises at least one core (102), be used to be provided at the inner chamber in pipe and the cover part, wherein mould (101) also comprises two first mould parts, top first mould part (104) and bottom first mould part (105), their interface (106) comprises first interface (107), first interface (107) is positioned at the zone of following (5) of corresponding cover, and can move perpendicular to interface (107) each other; And wherein mould (101) also comprises two other second mould part (108), and their second Move Mode is the portable cord perpendicular to first mould part;

-bottom first mould part (105) is removed from upper die part (104);

-by using second Move Mode, two second mould parts (108) are moved away from each other;

-core (102) moves in the direction identical with bottom first mould part (105) subsequently; And

-from mould, emit laryngeal mask (1) to finish.

24. method according to claim 23 is characterized in that, all or part of surface of core (102) is coarse.

25. according to claim 21 or 22 described methods, it is characterized in that the circumference of cover part forms by the upper and lower circumference by tongue and recess configurations configuration, it is also referred to as sun and cloudy structure, its subsequently by taping process against each other the assembling, so that the circumference big envelope (9) of basic closure to be provided.

26. according to claim 21 or 22 described methods, it is characterized in that, rigid conduit (114) is arranged in the extension of airway (2), so that realization is configured to the outside that the external jacket of the integral part of airway completely or partially centers on rigid conduit (114).

27. method according to claim 26 is characterized in that, airway (2) and cover part (3) are molded around rigid conduit (114).

28. method according to claim 27 is characterized in that, airway (2), cover part (3) and rigid conduit (114) are by identical polymer material manufacturing.

29., it is characterized in that pipe (18) is installed on the circumference big envelope (9) of laryngeal mask (1) subsequently according to claim 21 or 22 described methods, this pipe (18) provides valve (19) and guiding air bag (20) at the other end.