CN110433361A

CN110433361A - Micro-structure nozzle

Info

Publication number: CN110433361A
Application number: CN201810422123.2A
Authority: CN
Inventors: 林易廷; 陈柏全
Original assignee: WEIBANG SCIENCE AND TECHNOLOGY CO Ltd
Current assignee: WEIBANG SCIENCE AND TECHNOLOGY CO Ltd
Priority date: 2018-05-04
Filing date: 2018-05-04
Publication date: 2019-11-12
Anticipated expiration: 2038-05-04
Also published as: CN110433361B

Abstract

The invention discloses the micro-structural channel module that one can be applied to aerosolization device, it includes: one is covered with upper cover and forms the plate body of chamber, an entrance and exit flowed through for liquid.Plate body includes the plural protrusion walls being parallel on entire width, is defined as plural access between plural protrusion walls.In addition, it is micro- from the prominent plural number formed of plate body, it is distributed in at least a part of access.One central rods is disposed in proximity to the region of outlet and occupies region a large portion close to outlet, exports so that liquid can only be flowed to by longitudinal arrow path.Liquid flows through chamber from entrance and forms aerosol to outlet.D is defined as the distance between two adjacent microtrabeculaes, and W is the width of longitudinal arrow path.D and W are specifically designed, therefore aerosol has number aerodynamic diameter (MMAD) in scheduled quality.

Description

Micro-structure nozzle

Technical field

The present invention discloses a kind of micro-structure channel module, especially a kind of micro-structure channel module suitable for aerosolization device.

Background technique

Aerosolization device (Aerosolizer), also known as atomizer (Nebulizer) or sprayer (Atomizer), are used to Sufferer is allowed to be administered in a manner of sucking.Specifically, liquid preparation can be broken down into the gas with fine particle or drop Mist (Aerosol) uses the available more efficient suction efficiency of the sufferer of medicament and absorption efficiency.And above-mentioned small grain The size of son can be adjusted according to different breath states, such as: Chronic Obstructive Pulmonary Disease (Chronic Obstructive Pulmonary Disease, COPD), asthma, or in response in liquid preparation itself.Furthermore sufferer is made to exist It is also considerable that identical dosage is received in each therapeutic modality.In other words, aerosolization device is needed each time Use in can provide fixed dosage medicament, and it has fixed average particle size, that is to say, that in each operation Can generate in the quality of particular range number aerodynamic diameter (MMAD, Mass Median Aerodynamic Diameter) and Specifically by spraying duration (spray duration).Thus, it can the drug caused by reducing because of excessive medication Waste and risk.

The 1st figure is please referred to, an example aerosolization device is mainly disclosed, it includes: upper casing 964, lower casing 965, nozzle (Nozzle) 963, pipe 966, biasing assembly (Biasing element) 962, storage container 961.It is described during preparation Biasing assembly 962 (such as: spring) pass through the relative displacement stress between the upper casing 964 and the lower casing 965.Meanwhile it is quantitative Liquid (not shown) medicament 50 be sucked out by the storage container 961 to nozzle 963 through the guidance of the pipe 966, to prepare Carry out aerosolization.When the aerosolization device 90 is activated, this can be quantified liquid by strength caused by the biasing assembly 962 of non-stress Body medicament 912 pushes the nozzle 963 to and passes through the nozzle 963, generates aerosol and sucks for sufferer.Another illustrative aerosol Change device and operating mechanism can refer to American New Patent Case the 5,964,416th (its U.S. Patent Application No. is 08/726,219) Disclosure.

As disclosed in the 1st figure, the liquid preparation 912 of pressurization can be mobile along the mode put by A point to A ', also simultaneously by one High-voltage end is moved to another low-pressure end.In this way, which liquid preparation 912 can be sucked out and be pushed into the nozzle 963, and in liquid Medicament 912 can generate aerosol and the aerosol is discharged simultaneously when passing through the nozzle 963.During aerosolization, all components it Between maintain the proper sealing (Seal) to be considerable.Otherwise, aerosolization effect will receive destruction.For example, in nozzle 963 occurred leak and be likely to result in loss of pressure, thus cause dosage inaccuracy or the unsuitable shape of aerosol particles size Condition.And then MMAD and the spraying duration of influence aerosol, in order to avoid above-mentioned condition, in manufacture and assembling aerosolization device Various components when, it is necessary to maintain the attention and accuracy of height.However, because of the miniature of those aerosolization device assemblies (Miniature) size (it is usually in millimeter or smaller magnitude) reaches the extremely difficult and consuming that proper sealing can become Cost.Furthermore the component with different geometries and miniature sizes, may be easier to be worn or tear under hyperbaric environment It splits, the pressure of the hyperbaric environment is usually between 5~50 million pas (MPa), namely 50~500 bars (Bar).

For another aspect, nozzle 963 plays important role, and 912 aerosol of the liquid preparation chemical conversion of pressurization is micro- Small particles/drop aerosol and keep aerosol spouting with specific speed.As disclosed in the 1st figure, the liquid preparation 912 of pressurization It can be sucked out through the guidance of connecting tube to nozzle 963.In general, the liquid preparation 912 of pressurization can be with high speed flow nozzle 963, it is filtered through nozzle 963 and reduces flow velocity in controllable method, it is required for so that the medicament of exact dose is aerosolized State.The above-mentioned internal structure that must be all specifically designed nozzle 963 is to reach effect.The unsuitable design of nozzle 963 may cause Whole aerosolization process is hindered and shortens the service life of aerosolization device 90 or influence the accuracy of dosage.

One typical nozzle for being applied to aerosolization device includes the multiple devices with different geometries.Citing comes It says, some components have specific shape, such as are used to the elongated projection as filter.Some other components then have not Similar shape, such as the composition component to control the guidance system that liquid flows in nozzle.In brief, in the spray of the relevant technologies Mouth needs the combination of multiple components with different structure and/or functional character and interaction that desired atomization just can be achieved Effect.But since the size of nozzle constantly reduces, so that wherein fluid control is increasingly not easy.The knot of component in nozzle Structure, size and arrangement needs carefully design and implement, so that nozzle more efficiently acts on.Therefore, so that the design and system of nozzle The cost made often remains high.

The main purpose of present patent application is to provide a nozzle arrangements, and the nozzle arrangements have less complex knot Structure, design and arrangement.And the above-mentioned improvement nozzle formed can improve whole atomization quality and efficiency, while reduce manufacture Cost.Therefore, patient can enjoy more cost effective therapeutic scheme.

Summary of the invention

The present invention provides the micro-structure channel module for being applied to aerosolization device.The channel module includes one and is covered with Upper cover and form the plate body of chamber, an entrance and exit flowed through for liquid.

The plate body further comprises filter arrangement.Filter arrangement in embodiment includes protrusion walls, microtrabeculae, protrusion row With and combinations thereof.

In certain embodiments, the plate body includes and is arranged parallel to each other in the plural protrusion walls on entire width, therefore Form plural access.The protrusion walls along flow direction, flow direction on the whole on perpendicular to the entrance.In some embodiments In, plural microtrabeculae protrudes from the plate body and is formed and be distributed evenly in at least a part of access.However certain In embodiment, the composition of the protrusion walls can be continuous or discontinuous.One central rods be disposed in proximity to outlet region and Region a large portion close to outlet is occupied, is exported so that liquid can only be flowed to by longitudinal arrow path.Liquid enters certainly Mouth flows through chamber and forms aerosol to outlet.D is defined as the distance between two adjacent microtrabeculaes, and W is the width of longitudinal arrow path.D and W is specifically designed, therefore aerosol has scheduled MMAD.In certain embodiments, D and W is specifically designed efficiently to pass Pass lung of the medicament in sufferer of aerosolization.To achieve these objectives, the MMAD of the aerosol must be shorter than 5.5um, more, MMAD must be between 4~5.5um.In addition, the spraying duration will more preferably be about 1.6 seconds when the aerosol is less than 5.5um. Said combination improves fine particle and is transferred to specific region in the lung of user, thus generates more preferably treatment results.

In certain embodiments, the micro-structure channel module 1 and its composition component it is specially designed and arrangement, therefore have There is the liquid preparation 912 of specific feature that can be aerosolized and provides with scheduled MMAD and spraying duration.It is described The group of liquid preparation 912 becomes medicating active ingredients, stabilization agent and preservative.The medicating active ingredients system is selected from β-mimicry Object, inhibitor, anti-allergic agent, antihistaminicum and/or steroids or combinations thereof object.In addition to this, 912 system of liquid preparation is not Containing ethyl alcohol and have the particular range of certain characteristic, such as: viscosity and surface tension.

The action and effect of invention

The present invention is the micro-structure channel module 1 especially organized structure, can generate ideal aerosol under severe environment, sufferer Therefore it derives much benefit, because their aerosol Inhalation in Treating can operate under more diverse environment.

In conclusion micro-structure channel module 1 provided by the invention, since group structure and its micron-scale component complexity drop It is low, therefore be easier to make.And finished devices can transmit more exact dose and tool is ideal when operation aerosolization device every time MMAD and the aerosol of spraying duration.

Detailed description of the invention

One or more embodiments are illustrated by the not limited method of example in attached drawing picture, wherein having identical The component of reference number mark always shows similar assembly.Attached drawing is not isometric map, unless otherwise disclosure.

For Fig. 1 according to the preceding case, illustrate the known aerosolization device of an illustration cuts open lateral plan；

For Fig. 2 according to this exposure book, illustrate another known aerosolization device of illustration cuts open lateral plan；

Fig. 3 A, Fig. 3 B are according to the section Example of this exposure book, icon micro-structure channel module micro-structure channel module；

Fig. 4 A, Fig. 4 B, Fig. 4 C according to the section Example of this exposure book, a series of micro-structure channel module of icon Lateral sectional view.

Above-mentioned each diagram is only generalized schematic and and is not used for limiting claim of the invention.In those icons In, the size of each part for clarity on demand and may not be consistent with actual size.Reference used in each claim Label is not construed as limiting scope of the present invention patent yet and is used, such as uses the same or similar group in different figures Part label.

Wherein, the reference numerals are as follows:

1: channel module

2: central rods

3: spacer block

4: microtrabeculae

10: plate body

102: entrance

104: outlet

106: inclined wall

108: side wall

15: arrow path

18: access

50: aerosol

912: liquid preparation

52: protrusion row

5: protrusion walls

90: aerosolization device

20: upper cover

902: shell

904: pump chamber

906: spring housing

9062,962: biasing assembly

9062: spring

908,961: storage container

910,966: pipe

950: transmitting device

963: nozzle

964: upper casing

965: lower casing

A-A ': liquid flow direction

Specific embodiment

It will illustrate the contents of the present invention below with different embodiments.It please notes, the components such as device as described below, module It can be made of hardware (such as circuit), or (such as processing unit is written in program) is constituted by hardware and software.In addition, Different components can be integrated into single component, and single component can also be divided into different components.Such variation should all be in the present invention In the range of.

Disclosed herein the manufacture and use method such as following details of embodiment discussed.However, it should be appreciated that, Following embodiment discloses many applicable concept of the invention, and many different types of texts can be used in those concept of the invention To express and cover.The disclosed ad hoc approach for being used to make or use each embodiment is only and illustrates, and be not limiting as this below The range of invention other embodiments.

In various visual angles and illustrated embodiment in this exposure book, similar Ref. No. can be used to specify similar group Part.Next Ref. No. below will be specified in illustrative embodiments included in following figure in detail.In possible situation Under, with identical Ref. No. appeared in text narration in icon, it is used to refer to surely the same or similar component.In each diagram In, the mode that various shape can slightly give an exaggerated account with thickness is expressed, with meet clearly with the conditions such as readily discernible.It is described below will be special It does not point out to form the members of the device of the invention or has the component directly interacted with the device of the invention.It is intelligible It is, it can not be in many different forms by the component of special icon or description.In this exposure book, when referring to " embodiment " Refer to that feature related with the embodiment, structure, characteristic etc. have been contained at least one embodiment.Therefore, in this exposure book In when referring to " embodiment ", the embodiment of substantive reference may not all refer to the same embodiment.Furthermore special characteristic, structure, Or characteristic can be combined into any suitable aspect in one or more embodiments.It answers it is to be understood that below illustrate not Must be drawn according to actual ratio size, but drawn for clarity with the needs of understanding aspect are preferential.

In each diagram, similar Ref. No. is used to specify similar or alike component, and each diagram of the present invention is real Example is applied to be presented and describe whereby.The diagram presented herein not all meets its actual size, and in order to icon it is clear for the sake of, Icon may be by processing or the simplified processing of giving an exaggerated account.The technical field of the invention, which has usual skill, can know, according to The various applications and variation that disclosed each embodiment below this exposure book and diagram are derived, still should be regarded as of the invention Scope.

It should be appreciated that can refer to the component when mentioning a component and being located at another component " top " and be placed directly within The top of another component or refer to the component across other objects and be located at another component top.So, if mentioning one group When " direct " " top " positioned at another component of part, then it is above-mentioned across other objects the case where it is invalid.

It should be appreciated that unless having clear restriction in this exposure book, even if otherwise mentioning the item of " single " kenel in text Part still can be considered the condition comprising " multiple " kenel.Furthermore relevant term, such as " top " and " bottom ", can make herein For describing the relationship between single component as shown in each figures and other assemblies.

It should be appreciated that when describe component be located at other assemblies " under " when, can also interpret under different viewing angles For the component be located at other assemblies " on ".It is above-mentioned " under " term can cover the meaning of " on " or " under " simultaneously.

It should be appreciated that " about " word used in text, corresponds to and measure numerical value, such as: quantity, when continuing Between, aerosol measurement or when its analog, when special value covers ± 10% variance and more ± 5%, the variance can It is considered as the appropriate variance that can reach the be intended to purpose of this exposure.

Unless otherwise defined, otherwise each term (including technical term and scientific term) used in this exposure book has There is the identical definition that persond having ordinary knowledge in the technical field of the present invention is understood.Separately it will be appreciated that in this exposure book Have and refer to and also have in the dictionary generally used defined term, the interpretation of definition is and the technical field of the invention In cognition it is consistent, it is also consistent with the definition in this exposure book；And only directly defined herein, otherwise those terms are not Meeting is with ideal style or excessively formal mode is next interpreted.

Fig. 2 is that the aerosolization device an of example cuts open lateral plan, meets the section Example that present patent application illustrates. This aerosolization device 90 includes: shell 902, pump chamber 904, spring housing 906.Biasing assembly 9062 (such as: spring) it is coupled to shell 902, more particularly it is installed on spring housing 906.Spring housing 906 also holds (hold) storage container 908, wherein storage container 908 Liquid preparation 912 can be stored.Liquid preparation 912 can correspond to a pretrigger (Preactuation) of aerosolization device 90, thoroughly It crosses the guidance of pipe 910 and pulls out storage container 908.Specifically, before starting aerosolization device 90, shell 902 can be revolved Turn.Spring 9062 through shell 902 rotation and stress.In contrast, liquid preparation 912 by storage container 908 by remittance abroad extremely Pump chamber 904 and preparation be aerosolized.When aerosolization device 90 starts, can start to carry out aerosolization.When aerosolization device 90 starts, Relieving mechanism (not shown) can be triggered, and spring 9062 can be discharged from stress to non-stress.Aforesaid operations can produce Liquid preparation 912 is forced through transmitting device 950 in pump chamber 904, implies that micro-structure channel module by a raw strength, the strength 1 (i.e. nozzle) whereabouts.That is, liquid preparation 912 by by micro-structure channel module 1 to carry out aerosolization.It is micro- Structure channel module 1 is therefore to be able to the aerosol that manufacture has ideal particle size through special designing, and is to be controlled and essence The mode of true transmitting carries out.In this way, which the liquid preparation 912 of aerosolization can leave transmitting device 950, and it is discharged gas Atomizer 90, to allow sufferer to suck.The liquid preparation of embodiment includes can respiratory composition.As follows, liquid preparation can be liquid Solution.In more preferably embodiment, liquid preparation system is free of ethyl alcohol (ethanol-free).The details of more liquid preparations will be stated carefully Yu Hou.

Moreover, in the preferred embodiment, 912 system of liquid preparation without propellant (such as: chlorofluorocarbons (chlorofluorocarbon) or hydrofluoroalkane propellant (hydrofluoroalkane propellants)).Propellant To push the aerosol source for having drug, for common pressurized metered dose inhalers (metered dose inhalers, MDI). However, there may be the negative effects to environment for propellant.Therefore, more preferably, disclosed herein 90 energy of aerosolization device It is operated in the case where being not required to propellant.

Micro-structure channel module 1 is a most important component in aerosolization device 90, because it can be by 912 meeting of liquid preparation It is decomposed into the aerosol of fine particle or drop.Micro-structure channel module 1 in the aerosolization device 90 has the filtering of micro-structure With guidance system, and it is made of the plural number access 18 that micron-scale component and micron-scale component define.Work as liquid When medicament 912 is to flow through at a high speed the micro-structure channel module 1, micron-scale component will be partially blocked by the medicament of flowing and will It resolves into little particle.In addition, the configuration of micron-scale component and access 18 will increase fluid resistance, liquid flowing is reduced whereby Speed.

In order to promote effective aerosol deposition in lung, ideal aerosol must have the MMAD of particular range and hold by spraying The continuous time.For example, MMAD should be less than 5.5um, and spraying duration about boundary in 1.2~1.6 seconds.More preferably implementing In example, MMAD is between about 4~6um, and the spraying duration was about boundary in 1.2~1.6 seconds, more be about boundary in 1.4~1.6 seconds.MMAD is suitable for Inhalation in Treating between the aerosol of about 4~6um.The aerosol that MMAD is higher than particular range is more difficult It seem that aerosol is relatively easy to be deposited on throat in the lung for arriving at sufferer.On the other hand, MMAD is lower than the aerosol of particular range instead It increases undesirable aerosol to propagate, causes to arrive to the aerosol deficiency of patient lungs, be futile treatment.And when continuing by spraying Between, it if non-in particular range, will affect the suction efficiency of sufferer, increase and occur to block the chance with residue, and shadow It rings to treatment.Such as: undesirable effective spray time will lead to negative effect aerosolized medicament sufferer within a certain period of time Soakage.Present patent application, which provides a micro-structure channel module, can reach above-mentioned MMAD and spraying duration.More conclusions After being carefully set forth in.

Fig. 3 A~3B is the example of micro-structure channel module micro-structure channel module 1, meets what present patent application illustrated Section Example.

Fig. 3 A is the top view of micro-structure channel module micro-structure channel module 1, meets the portion that present patent application illustrates Divide embodiment.

Micro-structure channel module micro-structure channel module 1 includes that upper cover 20 and plate body 10 (are capped 20 coverings, do not show Out), aforementioned combination forms chamber housing filter arrangement.Liquid (not shown) by entrance 102 enter chamber and in aerosol form in It releases outlet 104.Filter arrangement ensures that aerosol 50 has above-mentioned characteristic to be suitable for human body Inhalation in Treating.For example, aerosol 50 has There are above-mentioned MMAD and spraying duration to be exposed in this.

Fig. 3 B is cross-sectional view of the micro-structure channel module 1 along X-X ' line shown in Fig. 3 A, as follows, micro-structure channel module 1 The entrance 102 flowed through comprising a plate body 10 and upper cover 20 and for liquid is with outlet 104, in addition, 20 shape of plate body 10 and upper cover At chamber 202, chamber 202 include filter arrangement (omission makes its clearer presentation chamber), with guide liquid flow direction or It is to change flow velocity.Filter arrangement is accessible or is not contacted with above-mentioned plate body 10 and upper cover 20, such as: filter arrangement can be protrusion Row 52, microtrabeculae 4, protrusion walls 5 and its combination from the prominent formation of plate body 10.Has the filter arrangement of this structure, aerosol tool 50 has Specific MMAD and spraying duration are exposed in this.

Fig. 4 A~4C is the top view of micro-structure channel module 1, meets the section Example that present patent application illustrates.

Fig. 4 A is please referred to, a micro-structure channel module 1 is disclosed.The micro-structure channel module 1 includes a plate body 10, and it can be as made by silica gel and its size are as follows: width about 2.5mm, length about 2mm, depth about 700um. Plate body 10 covers glass top cover 20 (not shown go out), width about 2.5mm, length about 2mm, depth about 675um.Plate 10 size of body corresponds to upper cover 20 and forms chamber.In addition, plate body 10 and 20 (not shown) of upper cover combine, opposite both ends It is defined as entrance 102 and outlet 104.There are two sidewalls 108 between the entrance 102 and outlet 104, between side wall 108 away from From the width for plate body 10,912 (not shown) of liquid preparation enters chamber by 102 end of entrance, and the aerosol 50 of generation is by outlet 104 Leave chamber in end.102 width of entrance is 2mm, wider than the outlet 104.Liquid preparation 912 is in chamber along general side To by the flow direction of entrance 102 outlet 104.Liquid flow direction of the liquid preparation 912 in channel module on the whole on perpendicular to entering Mouth 102, and it is defined as A-A '.At least partly liquid preparation 912 is flowed along the inclined wall 106 of channel module 1, and lead to liquid Body confluence and mutually collision, or preferably confluence angle is about 90 °.According to the above results, thus produce for patient's sucking Aerosol 50.

Plate body 10 further includes central rods 2, spacer block 3, microtrabeculae 4 and protrusion walls 5.Microtrabeculae 4, spacer block 3 and protrusion walls 5 Rearrange the filter arrangement of micro-structure channel module 1, and spacer block 3, protrusion walls 5, microtrabeculae 4 and central rods 2 with liquid flow It is prominent to move crosscutting direction.In certain embodiments, spacer block 3 is arranged in multiple row, two adjacent spacer blocks 3 in entrance 102 The distance between be twice of 18 width of access.The cross sectional shape of each spacer block 3 is rectangle, and width is about 50um, long Spend about 200um.In general, spacer block 3 enters the liquid preparation 912 of chamber and is classified as separated for primary filtration Access 18.

In certain embodiments, these components can become one of plate body 10 through micro-structural channel module 1 is etched Divide and is formed.In certain embodiments, the etch depth of plate body 10 about 5~6um to form part above-mentioned in one piece Component, depth cover the manufacture allowable error of 1um.It is worth noting that, the manufacturing method of plate body 10 is not limited to this.Plate Body 10 can be made up of other modes known to related fields, such as: molding, welding or printing.Subsequent interior text will be into one Other feature and structure of step description black box.

Refering to Fig. 4 B, the position prominent and close to outlet 104 from plate body 10 of central rods 2.The shape of central rods 2 is close to ball Shape, and its partial size is about 150um.Central rods 2 occupy region a large portion close to outlet 104, and make liquid Only outlet 104 can be flowed to by two arrow paths 15 between central rods 2 and inclined wall 106.Arrow path 15 is at least certain part It is extended continuously and to be longitudinal, in other words, part inclined wall 106 is parallel to corresponding 2 region of central rods.Above structure will be made It flows, i.e., flows along two opposite arrow paths 15 toward relative direction at liquid.In other words, micro-structure channel module 1 can be managed Solution is comprising two outlets 104 to carry out aerosolization.Accordingly, the opposite liquid injection for ejecting two arrow paths 15 intersects at access mould Outside block 1 and close to the position of outlet 104, and form aerosol 50.The size of central rods 2 makes the width W of each arrow path 15 be situated between In about 6.7~8.3um, more, the width W of arrow path 15 is between about 7~8um.It is worth noting that, here, distance D And the manufacture allowable error of width W is about ± 0.3um.In certain embodiments, width W refers to inclined wall 106 in The distance between column 2 is entreated, measurement is shown in Fig. 4 B.

Refering to Fig. 4 A and 4B, plate body 10 further includes protrusion walls 5 and is arranged on the entire width of plate body 10, the present invention Filter arrangement further include this protrusion walls 5, to be longitudinal and parallel to each other in liquid flow direction A-A'.Each parallel Access 18 between protrusion walls 5 to be flowed for liquid preparation 912.Liquid flows in plural access 18 along direction A-A'.Institute The width about 77um of access 18 is stated, the general width of protrusion walls 5 is about 22um.

In certain embodiments, for the unfiltered liq medicament 912 into micro-structure channel module 1, two protrusion walls Space between 5 is as filter, for example, any size is greater than the particle of 18 width of access, will be stopped and mistake by the space It filters out.Protrusion walls 5 further guide liquid flow direction, flow liquid more uniformly along direction A-A', reduce accordingly disorderly Stream.

In certain embodiments, as shown in Figure 4 C, protrusion walls 5 are discrete.For example, plural protrusion row 52 arranges To form protrusion walls 5.In particular, there is gap between two adjacent protrusion rows 52, the liquid flowed between each access 18 Cognition is laterally flowed by the gap between protrusion row 52.Importantly, all disclosed by present patent application be directed to protrusion walls 5 technical characteristic is suitable for continuous and discontinuous protrusion walls 5.In other embodiments, only prominent without utilizing using microtrabeculae 4 It plays wall 5 and filtering function is provided.

As shown in figs. 4 a-4 c, microtrabeculae 4 is round and is uniformly distributed.Above-mentioned configuration forms the filter arrangement of symmetric patterns. Therefore, symmetrical liquid flowing is formed by protrusion walls 5 and microtrabeculae 4 to reduce the chance that sinuous flow occurs in chamber, also will affect The effect of aerosolization.Microtrabeculae 4 is the micron-scale component from 10 protrusion of plate body, and height is about 5~6um.Between microtrabeculae 4 away from From for D, and distance D is between about 6.7~8.3um.More preferably, distance D is between about 7~8um.The distribution of microtrabeculae 4 provided Filtrate body is at fine particle, or increases flow resistance between liquid preparation 912.Therefore, flow velocity of the liquid in chamber is reduced.So And in certain embodiments, plate body 10 includes protrusion walls 5 and microtrabeculae 4, but microtrabeculae 4 is not present between arrow path 15.

Fig. 4 A to Fig. 4 C is please referred to, protrusion walls 5 originate in entrance 102 and extend toward outlet 104, and protrusion walls 5 are extensible It can be not required to extend beyond the junction of side wall 108 Yu inclined wall 106.In addition, protrusion walls 5 or it is non-originate in entrance 102, In an example, protrusion walls 5 originate in away from 102 a distance of entrance.And microtrabeculae 4 occupies the access at least partly region 18.Moreover, microtrabeculae 4 occupies plate body 10 close to the region of outlet 104, and protrusion walls 5 is not being utilized to be filtered or dash forward Playing wall 5 is in discontinuous embodiment, and microtrabeculae 4 is uniformly distributed in plate body 10.Its " occupying " word is used herein, is referred to micro- Column 4 is present in around plate body 10 but not exclusively blocking liquid flowing.In certain embodiments, plate body 10 can be considered comprising the firstth area Domain and second area, first area is compared with second area close to entrance 102.In addition, in certain embodiments, access 18 is located at first Region and without protrusion walls 5 in second area, microtrabeculae 4 occupies at least second area, and part but the firstth not all area Domain.

The following contents will focus on following table one, and table one provides drop size, for by Next Generation The MMAD of Impactor (NGI) measurement.(please refer to USP 36 (601) Aerosols, Nasal Sprays, Metered-Dose Inhalers,AND Dry Powder Inhalers for aqueous solution).In this exposure, in the liquid of pressurization In body, distance D and width W are specifically designed, and generated aerosol can have scheduled MMAD and spraying duration.

Table one

Table one discloses measurement result (n=3), and the MMAD of aerosol 50 is less than about 5.5um.Or preferably, aerosol it MMAD is between about 4~5um.In addition, the spraying duration of above-mentioned aerosol was less than 1.6 seconds.Or it is preferably, above-mentioned spraying lasting Time was between about 1.2~1.6 seconds.Or more preferably, the above-mentioned spraying duration was between about 1.4~1.6 seconds.Correspondingly, Spray velocity of aerosol injection when exporting 104 is between about 169~175m/s.Table one further provides in fluid under pressure The comparison of fine particle ratio (fine particle fraction, FPF) less than 5 microns.In one embodiment, drop is small In 5 microns of ratios less than 50%.Or preferably, above-mentioned ratio between 35%~45%.

In order to reach the above results, distance D and width W need to be specifically designed.In certain embodiments, width W is between big About 7~8um and distance D is between about 7~8um.Or preferably, one of them is less than 8um and/or width in width W and distance D It spends other one in W and distance D and is greater than 7um.When above-mentioned structure design is less than 5.5um and continues by spraying for generating MMAD Between between about 1.5~1.6 seconds be beneficial, as described above, ideal particle size therefore could be generated and to transmit medicine The mist of Wu Zhi sufferer lung.

In other words, sufferer can suck the gas of the ideal particle size of fixed dosage in operation aerosolization device 90 every time Mist.However, present application for patent is not limited to describe on text, that is to say, that any to appear in the specific of aforementioned table one The combination of the width W and distance D above-mentioned of range, fall within this patent claim.In addition to this, as described above, this exposure Effective in generating the aerosol of tool ideal MMAD and spraying duration.

However, the liquid with specific feature is related with the operation of aerosolization device 90 and desired result.Specifically, aerosol Change device 90 by at least pressure of 50bar, transmitting is less than the liquid of 20ul, to generate tool curative effect and be free of the aerosol of propellant. To generate effective curative effect, aerosol must have the characteristic disclosed herein.In order to achieve the above object, liquid itself and its environment are then necessary It is controlled.

In a particular embodiment, liquid composition does not include propellant gas, and further, liquid composition includes medicinal activity Ingredient, stabilization agent and preservative.The medicating active ingredients system is selected from β-mimetic (betamimetics), inhibitor (anticholinergics), anti-allergic agent (antiallergics), antihistaminicum (antihistamines) and/or class are solid Alcohol (steroids) or combinations thereof object.For example, medicating active ingredients can be selected from albuterol sulfate (Albuterol Sulfate), Ipratropium Bromide (Ipratropium Bromide), tiotropium (Tiotropium), Ao Dateluo (Olodaterol), budesonide (Budesonide), Formoterol (Formoterol), Fino Tero (Fenoterol) etc.. Active constituent ideal concentration in solution is 0.001~2g/100ml.Suitable stabilization agent can be that concentration is 0.001 in solution The ethylenediamine tetra-acetic acid (EDTA, ethylenediamine tetraacetic acid) of~1 mg/ml, specifically, concentration For less than about 0.5mg/ml, and more, concentration is less than about 0.25mg/ml.Suitable preservative can be Lvization Benzyl alkane Ammonium (Benzalkonium Chloride).In addition, the pH value of solution composition, which need to adjust, sets particular range, therefore solution composition can Include citric acid and hydrochloric acid.In specific preferred embodiment, the ingredient of liquid may be the thiophene support of 0.22~023 mg/ml The zephiran of bromine ammonium (Tiotropium Bromide) or its analog, 0.08~0.12 mg/ml (Benzalkonium) or the EDTA or its analog of its analog and 0.08~0.12 mg/ml.In addition, pH value between 2.7~3.1.Acid ph value is for stablizing composition and reaching the degree of transmission optimal dosage.In addition, in specific preferred embodiment In, liquid is low-viscosity (viscosity), at room temperature about 0.88cP, and surface tension circle of liquid is in about 43~48 dyne.In other embodiments, the aerosol for being free of propellant is formed after liquid is aerosolized, to impose on the lung of patient.

As shown in Fig. 2, liquid is stored in storage container 908, it is then transmitted in aerosolization device 90.Importantly, liquid System does not include the ingredient or medicinal property that any discomfort is worked as, and aerosolization device 90 or storage container 908 is caused to damage or react.Example Such as, liquid can be non-ethanol solution, therefore storage-stable in container.Further, the effective quantity of medicating active ingredients with And the stabilization agent of ideal concentration is then avoided that device damage or corrosion, and such as: if the concentration using EDTA, in solution composition Need to be optimised, the EDTA of high concentration will form the chance of crystallization in the solution channel for increasing nozzle, and cause to block or hinder.

Apart from the above, the design combination of the specific structure of micro-structure channel module 1 and the selection of liquid composition, make Aerosolization device 90 generates the aerosol with scheduled MMAD and spraying duration under wider array of temperature range.Next, with Lower content will discuss following table two.

Table two

Table two shows the micro-structure channel module 1 through especially group structure in this exposure, influence at different operating temperatures.By It is above-mentioned it is found that aerosolization device (n=3) can operate between about 4~25 degrees Celsius of operation temperature.In an example, there is medicament Storage container be stored on refrigerator, enable storage container be in 4 degrees Celsius of environment before operation.As shown in Table 2, this exposure In micro-structure channel module 1 can generate the aerosol of similar characteristic between 4~25 degrees Celsius.In other words, this in this exposure is special The micro-structure channel module 1 of other group of structure can generate ideal aerosol under severe environment.Sufferer is because aerosol Inhalation in Treating can be It operates and is benefited under more diverse environment.In addition, aerosolization device becomes more suitable for specific in this operating temperature range The liquid preparation of liquid viscosity, in certain embodiments, the viscosity of liquid medicine are adjusted to about 0.5~3cP, specific More preferably in embodiment, viscosity range is between about 0.8~1.6cP.And high viscosity may influence the particle average size of aerosol And the spraying duration, therefore it is preferably maintained in lower viscosity.In addition to this, this micro-structure channel module 1 in this exposure Group structure makes it more suitable for the liquid preparation with particular surface tension, in certain embodiments, the surface tension of liquid preparation Range is between about 20~70mN/m, or more preferably, between about 25~50mN/m.Lower surface tension can provide medicine The preferable diffusivity of agent, therefore increase aerosol in the deposition on lung surface, promote the validity and Inhalation in Treating of medicament.

Therefore, above-mentioned ideal liquid form under conditions of, micro-structure channel module 1 its with width W between about 6.7~8.3um and distance D between about 6.7~8.3um, viscosity range be 0.5~3cP (operation temperature is about 4~ 25 degrees Celsius), more preferably aerosol can be generated, MMAD is less than about 5.5um, or more preferably, spraying to continue between 4~5.5um Time is less than 1.6 seconds, or more preferably, between 1.4~1.6 seconds and ratio of the drop less than 5 microns less than 50%.Or more preferably, Above-mentioned ratio is between 25%~40%.With this condition, aerosol Inhalation in Treating system is more effective.

The action and effect of embodiment

Above embodiment is preferred case of the invention, the protection scope being not intended to limit the invention.

Claims

1. one be applied to aerosolization device micro-structure channel module, characterized by comprising:

Plate body, be covered with upper cover and formed the chamber that chamber and the plate body and the top cover combination define entrance and Outlet, liquid from the entrance flow through the chamber to the outlet direction definition be liquid flow direction；

Plural number is parallel on the entire width of the plate body along the protrusion walls of the liquid flow direction, and described multiple Plural access is defined as between number protrusion walls；

Plural microtrabeculae is formed from plate body protrusion, and its adjacent distance definition is D；

Central rods form from plate body protrusion, approach and mostly occupy the outlet, form arrow path in the center Between column and the outlet, so that the liquid flows through, and the arrow path width is W；

Wherein, the liquid flows through the chamber along the liquid flow direction, generates number aerodynamic diameter in scheduled quality (MMAD) aerosol；

Wherein, the width W is between 6.7~8.3um and the distance D between 6.7~8.3um.

2. micro-structure channel module as described in claim 1, it is characterised in that:

Wherein, at least one the described width W or distance D is less than 8um.

3. micro-structure channel module as claimed in claim 2, it is characterised in that:

Wherein, at least one the described width W or distance D is greater than 7um.

4. micro-structure channel module as described in claim 1, it is characterised in that:

Wherein, the scheduled MMAD is less than 5.5um.

5. micro-structure channel module as described in claim 1, it is characterised in that:

Wherein, the aerosolization device further have the spraying duration be 1.2~1.6 seconds.

6. micro-structure channel module as described in claim 1, it is characterised in that:

Wherein, ratio of the drop size of the aerosol less than 5 microns is less than 50%.

7. micro-structure channel module as described in claim 1, it is characterised in that:

Wherein, ratio of the drop size of the aerosol less than 5 microns is between 35~45%.

8. micro-structure channel module as described in claim 1, it is characterised in that:

Wherein, the section of the microtrabeculae is circle.

9. micro-structure channel module as claimed in claim 8, it is characterised in that:

Wherein, the microtrabeculae system is evenly distributed.

10. micro-structure channel module as described in claim 1, it is characterised in that:

Wherein, the liquid system is free of ethyl alcohol.

11. micro-structure channel module as described in claim 1, it is characterised in that:

Wherein, the viscosity of the liquid is between 0.5to3cP.

12. one be applied to aerosolization device 90 micro-structure channel module, characterized by comprising:

Plate body, be covered with upper cover and formed the chamber that chamber and the plate body and the top cover combination define entrance and Outlet；

Filter arrangement is set on the plate body；And

Wherein, the liquid flows through the chamber to the outlet from the entrance, and the filter arrangement increases the liquid Flow resistance generates MMAD (number aerodynamic diameter in quality) and is less than the aerosol of 5.5um；

Wherein, the width W is between 6.7~8.3um；And

Wherein, the liquid contains tool medicating active ingredients, stabilization agent and preservative.

13. micro-structure channel module as claimed in claim 12, it is characterised in that:

Wherein, the width W is between 7~8um.

14. micro-structure channel module as claimed in claim 12, it is characterised in that:

Wherein, the liquid system is free of ethyl alcohol.

15. micro-structure channel module as claimed in claim 12, it is characterised in that:

Wherein, operation temperature is lower than 25 degrees Celsius.

16. micro-structure channel module as claimed in claim 12, it is characterised in that:

Wherein, the viscosity of the liquid is less than 3cP.

17. micro-structure channel module as claimed in claim 16, it is characterised in that:

Wherein, the viscosity of the liquid is between 0.8~1.6cP.

18. micro-structure channel module as claimed in claim 12, it is characterised in that:

Wherein, the medicating active ingredients system is selected from β-mimetic, inhibitor, anti-allergic agent, antihistaminicum or combinations thereof object.

19. micro-structure channel module as claimed in claim 18, it is characterised in that:

Wherein, the stabilization agent is EDTA and concentration is lower than 0.25mg/ml.

20. micro-structure channel module as claimed in claim 12, it is characterised in that:

Wherein, after the liquid is aerosolized, the aerosol without propellant to impose on sufferer lung is formed.