CN209713890U - Microstructure nozzle - Google Patents

Abstract

The utility model discloses a can be applied to micro-structure nozzle of gas atomizer, it contains: a plate covered with a cover to form a chamber, an inlet and an outlet through which a liquid can flow. The plate body comprises a plurality of protruding walls which are arranged in parallel on the whole width, and a plurality of passages are defined among the protruding walls. In addition, a plurality of micro-vias are formed protruding from the plate body and distributed in at least a portion of the vias. A central column is disposed in the region near the outlet and occupies a substantial portion of the region near the outlet so that liquid can only flow through the longitudinal channels to the outlet. The liquid flows through the chamber from the inlet to the outlet to form an aerosol. D is defined as the distance between two adjacent micropillars, and W is the width of the longitudinal narrow channel. D and W are specifically designed so that the aerosol has a predetermined Mass Median Aerodynamic Diameter (MMAD).

Description

microstructure nozzle

technical field

The utility model discloses a microstructure passage module, in particular a microstructure passage module suitable for an aerosolizer.

Background technique

Aerosolizer, also known as Nebulizer or Atomizer, is used to allow patients to inhale medicine. In particular, the liquid medicine will be decomposed into an aerosol with tiny particles or liquid droplets, and patients who use the medicine can obtain more efficient inhalation and absorption efficiency. The size of the aforementioned tiny particles can be adjusted according to different respiratory conditions, such as chronic obstructive pulmonary disease (Chronic Obstructive Pulmonary Disease, COPD), asthma, or in response to the liquid medicine itself. Furthermore, it is also very important that patients receive the same dosage in each treatment modality. In other words, the aerosolizer needs to provide a fixed dose of medicament in each use, and it has a fixed average particle size, that is to say, it can produce a specific range of mass median aerodynamic particle size ( MMAD, Mass Median Aerodynamic Diameter) and a specific spray duration. In this way, the waste and risk of drugs caused by over-medication can be reduced.

Please refer to FIG. 1 , which mainly discloses an example aerosolizer, which includes: an upper shell 964 , a lower shell 965 , a nozzle (Nozzle) 963 , a tube 966 , a biasing element (Biasing element) 962 , and a storage container 961 . During preparation, the biasing member 962 (eg, a spring) is stressed by the relative displacement between the upper shell 964 and the lower shell 965 . At the same time, a certain amount of liquid (not shown) medicament 50 is sucked out from the storage container 961 to the nozzle 963 through the guide of the tube 966 to prepare for aerosolization. When the aerosolizer 90 is activated, the force generated by the unstressed bias assembly 962 will push the metered liquid medicament 912 toward the nozzle 963, and make it pass through the nozzle 963, generating an aerosol supply to the patient. suffer from inhalation. Another exemplary aerosolizer and its operating mechanism can be found in US Patent Application No. 5,964,416 (US Patent Application No. 08/726,219).

As shown in FIG. 1, the pressurized liquid medicine 912 will move along the way from point A to point A', and at the same time move from one high-pressure end to the other low-pressure end. In this way, the liquid medicament 912 will be sucked out and pushed into the nozzle 963, and when the liquid medicament 912 passes through the nozzle 963, an aerosol will be generated and the aerosol will be discharged at the same time. During the aerosolization process, it is very important to maintain a proper seal (Seal) between all components. Otherwise, the aerosolization effect will be destroyed. For example, a leak at the nozzle 963 may cause a loss of pressure, resulting in inaccurate dosing or improper particle size of the aerosol. In turn, it affects the MMAD of the aerosol and the duration of the spray. In order to avoid the above situation, a high degree of attention and precision must be maintained when manufacturing and assembling the various components of the aerosolizer. However, because of the Miniature size of these aerosolizer components (which are typically on the order of millimeters or less), achieving a proper seal can be extremely difficult and costly. Furthermore, components with different geometries and miniature sizes may be more susceptible to wear or tear in high-pressure environments, which typically have a pressure of 5 to 50 megapascals (MPa), that is, 50 to 500 bars (Bar).

On the other hand, the nozzle 963 plays an important role in aerosolizing the pressurized liquid medicine 912 into an aerosol of tiny particles/droplets and ejecting the aerosol at a specific speed. As disclosed in FIG. 1 , the pressurized liquid medicine 912 is sucked out to the nozzle 963 through the guide of the connecting tube. In general, the pressurized liquid medicament 912 flows into the nozzle 963 at a high velocity, is filtered through the nozzle 963 and the flow rate is reduced in a controllable manner, so that the precise dose of the medicament can be aerosolized to the desired state. All of the above needs to specially design the internal structure of the nozzle 963 to achieve the effect. Improper design of the nozzle 963 may cause the complete aerosolization process to be hindered and shorten the service life of the aerosolizer 90 or affect the accuracy of the dose.

A typical nozzle used in an aerosolizer contains a plurality of components with different geometries. For example, some components have specific shapes, such as elongated protrusions that act as filters. Some other components have different shapes, such as components of the guiding system used to control the flow of liquid in the nozzle. In short, the nozzles in the related art require the combination and interaction of multiple components with different structural and/or functional features to achieve the desired atomization effect. However, as the size of nozzles continues to shrink, fluid control is becoming increasingly difficult. The structure, size and arrangement of the components in the nozzle need to be carefully designed and implemented in order for the nozzle to function efficiently. Therefore, the cost of designing and manufacturing the nozzle is often high.

The main object of this patent application is to provide a nozzle structure which has a less complicated structure, design and arrangement. The improved nozzle formed above will improve the overall atomization quality and efficiency, and reduce the manufacturing cost at the same time. As a result, patients can enjoy more cost-effective treatment options.

Utility model content

The utility model provides a microstructure passage module applied to a gas atomizer. The passage module includes a plate body covered with a top cover to form a chamber, an inlet and an outlet for liquid to flow through.

The plate body further includes a filtering structure. Filtration structures in embodiments include raised walls, micropillars, raised rows, and combinations thereof.

In some embodiments, the plate comprises a plurality of protruding walls arranged parallel to each other across its entire width, thereby forming a plurality of channels. The protruding wall is along a flow direction which is substantially perpendicular to the inlet. In some embodiments, a plurality of micropillars protrude from the plate and are evenly distributed in at least a part of the passage. In some embodiments, however, the raised walls may be continuous or discontinuous in composition. A central column is arranged in the area close to the outlet and occupies a substantial part of the area close to the outlet, so that the liquid can only flow to the outlet through the longitudinal narrow channel. The liquid flows through the chamber from the inlet to the outlet to form an aerosol. D is defined as the distance between two adjacent micropillars, and W is the width of the longitudinal narrow channel. D and W are specially designed so that the aerosol has a predetermined MMAD. In certain embodiments, D and W are specifically designed to efficiently deliver an aerosolized drug to the patient's lungs. To achieve the above purpose, the MMAD of the aerosol must be less than 5.5um, more particularly, the MMAD must be between 4-5.5um. Furthermore, when the aerosol is less than 5.5um, the spray duration will more preferably be about 1.6 seconds. The above combination enhances the delivery of the microparticles to specific areas in the user's lungs, thereby producing more desirable therapeutic results.

In some embodiments, the microstructure access module 1 and its components are specially designed and arranged so that the liquid medicament 912 with specific characteristics can be aerosolized and provided with a predetermined MMAD and spray duration. The composition of the liquid medicine 912 is a medical active ingredient, a stabilizer and a preservative. The pharmaceutical active ingredients are selected from β-mimetic substances, inhibitors, antiallergic agents, antihistamines and/or steroids or combinations thereof. In addition, the liquid medicine 912 does not contain ethanol and has a specific range of certain properties, such as viscosity and surface tension.

Function and effect of utility model

The utility model is a microstructure access module 1 specially structured to generate ideal aerosol in harsh environments, and patients benefit a lot because their aerosol inhalation therapy can be operated in more diverse environments .

To sum up, the microstructure access module 1 provided by the present invention is easier to manufacture due to the reduced complexity of the fabric and its micron-sized components. The finished device can deliver a more precise dose of aerosol with ideal MMAD and spray duration each time the aerosolizer is operated.

Description of drawings

One or more embodiments are illustrated by way of example and not limitation in the figures of the drawings, wherein components identified with the same reference numerals represent similar components throughout. The drawings are not to scale unless otherwise disclosed.

Fig. 1 illustrates a sectional side view of an example of a conventional aerosolizer according to said prior art;

Figure 2 illustrates a cutaway side view of another exemplary conventional aerosolizer according to the present disclosure;

FIG. 3A and FIG. 3B illustrate the microstructure access module and the microstructure access module according to some embodiments of the disclosure;

4A , 4B and 4C illustrate a series of side cross-sectional views of microstructure access modules according to some embodiments of the present disclosure.

The above diagrams are only schematic diagrams and are not intended to limit the patent scope of the present invention. In these diagrams, the size of each component does not necessarily correspond to the actual size for the sake of clarity. The reference signs used in the claims are not used to limit the patent scope of the present application, for example, the same or similar component numbers are used in different drawings.

Wherein, the reference signs are explained as follows:

1: Access module

2: Central column

3: spacer block

4: microcolumn

10: board body

102: Entrance

104: Export

106: Inclined Wall

108: side wall

15: Narrow Road

18: Access

50: Aerosol

912: Liquid Elixir

52: Raised rows

5: Protruding wall

90: Aerosolizer

20: top cover

902: shell

904: Pump room

906: Spring Room

9062, 962: Bias components

9062: Spring

908, 961: storage container

910,966: Tubes

950: Transmission Device

963: nozzle

964: upper shell

965: lower shell

A-A': Liquid flow direction

Detailed ways

The content of the present invention will be described below with different embodiments. Please note that the devices, modules and other components described below may be composed of hardware (such as a circuit), or composed of hardware and software (such as writing a program into a processing unit). In addition, different components can be integrated into a single component, and a single component can also be divided into different components. Such changes should all be within the scope of the present invention.

Methods of making and using disclosed embodiments of the present invention are discussed in detail below. However, it should be understood that the following embodiments disclose many applicable novel concepts, and these novel concepts can be expressed and covered by many different kinds of words. The specific methods for making or using the embodiments disclosed below are only examples and do not limit the scope of other embodiments of the present invention.

Like reference numerals may be used to designate like components throughout the various perspectives and illustrated embodiments in this disclosure. The following reference numbers subsequently designate in detail the illustrative embodiments contained in the following figures. Where possible, the same reference numbers appearing in the icons as in the text are used to designate the same or similar components. In each diagram, various shapes and thicknesses may be expressed in a slightly exaggerated manner to meet conditions such as clarity and easy recognition. The following description will specifically refer to components that form part of, or directly interact with, the device of the present invention. It is to be understood that components not specifically shown or described may take many different forms. In this disclosure, when referring to "an embodiment", it means that the features, structures, characteristics, etc. related to the embodiment are included in at least one embodiment. Therefore, when "an embodiment" is mentioned in this disclosure, the embodiments referred to in substance may not all refer to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. It should be understood that the following illustrations are not necessarily drawn in accordance with actual scale, but are drawn with priority for clarity and understanding.

In the various figures, like reference numerals are used to designate similar or like components, and various illustrated embodiments of the invention are presented and described herein. The icons presented here are not all of their actual size, and the icons may be exaggerated or simplified for the sake of clarity. Those with ordinary knowledge in the technical field of the present invention should know that various applications and changes derived from the various embodiments and illustrations disclosed below in this disclosure should still be regarded as the scope of the present invention.

It should be understood that when an element is referred to as being "above" another element, it may mean that the element is placed directly on the other element, or that the element is placed on the other element through other objects. above the component. However, when it is mentioned that one component is "directly" on another component, the above situation is not true across other objects.

It should be understood that even if a "single" type of condition is mentioned in the text, it can still be considered to include "multiple" types of conditions unless clearly defined in this disclosure. Furthermore, related terms, such as "top" and "bottom," may be used herein to describe the relationship of a single component to other components as shown in the figures.

It should be understood that when it is described that an element is “below” other elements, it may also be interpreted as being “above” other elements from different perspectives. The term "below" above can also cover the meaning of "above" or "below".

It should be understood that when the term "about" is used herein, it corresponds to a measured value, such as: amount, duration, aerosol measurement or the like, when the specified value includes ± 10% variation and more specifically ±5%, the variance can be regarded as an appropriate variance that can achieve the intended purpose of this disclosure.

Unless otherwise defined, each term (including technical terms and scientific terms) used in this disclosure has the same definition as understood by those skilled in the art to which this invention belongs. It is also understandable that the interpretation of the terms mentioned in this disclosure and also defined in commonly used dictionaries is consistent with the cognition in the technical field to which the present invention belongs, and is also consistent with this disclosure. ; and unless defined directly here, these terms are not to be interpreted ideally or in an overly formal way.

Figure 2 is a cross-sectional side view of an exemplary aerosolizer, consistent with some of the embodiments described in this patent application. This gas atomizer 90 comprises: housing 902, pump chamber 904, spring chamber 906. A biasing component 9062 (eg, a spring) is coupled to the housing 902 , and more particularly to the spring chamber 906 . The spring chamber 906 also holds a storage container 908 , wherein the storage container 908 can store a liquid medicament 912 . The liquid medicine 912 can be drawn out of the storage container 908 through the guidance of the tube 910 corresponding to a preactuation of the aerosolizer 90 . In particular, before activating the aerosolizer 90, the housing 902 is rotated. The spring 9062 is stressed by the rotation of the housing 902 . In contrast, liquid medicament 912 is pumped from storage container 908 to pump chamber 904 and is ready to be aerosolized. When the aerosolizer 90 is activated, aerosolization will begin. When the aerosolizer 90 is activated, the release mechanism (not shown) will be triggered, and the spring 9062 will be released from the stressed state to the unstressed state. The above operation creates a force that pushes the liquid medicament 912 in the pump chamber 904 through the delivery device 950, ie where the microstructured access module 1 (ie nozzle) is located. That is to say, the liquid medicine 912 is aerosolized by passing through the microstructure access module 1 . The microstructure passage module 1 is specially designed so that the aerosol with ideal particle size can be produced in a controlled and precise delivery manner. As such, the aerosolized liquid medicament 912 exits the delivery device 950 and is expelled from the aerosolizer 90 for inhalation by the patient. The liquid medicament of an embodiment includes a respirable composition. As follows, a liquid medicament may be a liquid solution. In a more preferred embodiment, the liquid dosage form is ethanol-free. The details of more liquid medicines will be described later.

Furthermore, in a preferred embodiment, the liquid medicine 912 does not contain propellants (such as chlorofluorocarbon or hydrofluoroalkane propellants). The propellant is used to propel the aerosol source containing the drug, and is used in common pressure metered dose inhalers (metered dose inhalers, MDI). However, propellants can have negative effects on the environment. Therefore, preferably, the presently disclosed aerosolizer 90 is capable of operating without the need for a propellant.

The microstructure passage module 1 is the most important component in the aerosolizer 90 because it can decompose the liquid medicine 912 into an aerosol of tiny particles or liquid droplets. The microstructure channel module 1 in the aerosolizer 90 has a microstructure filtering and guiding system, and is composed of micron-sized components and multiple channels 18 defined by the micron-sized components. When liquid medicament 912 flows through the microstructure access module 1 at high speed, the micron-sized components will partially block the flowing medicament and decompose it into small particles. Additionally, the configuration of micron-sized components and passageways 18 will increase fluid resistance, thereby reducing liquid flow velocity.

To enhance effective aerosol deposition in the lungs, an ideal aerosol must have a specific range of MMAD and nebulization duration. For example, MMAD should be less than 5.5um, and the spray duration is about 1.2-1.6 seconds. In a more preferred embodiment, the MMAD is about 4-6um, and the spray duration is about 1.2-1.6 seconds, more preferably about 1.4-1.6 seconds. The aerosol with MMAD between about 4-6um is suitable for inhalation therapy. The aerosol with MMAD above a certain range is more difficult to reach the patient's lungs, for example, the aerosol is easier to deposit in the throat. On the other hand, an aerosol with MMAD below a certain range increases undesired aerosol transmission, resulting in insufficient aerosol reaching the patient's lungs, which is an ineffective treatment. However, if the spray duration is not within a specific range, it will affect the patient's inhalation efficiency, increase the chance of blockage and residue, and affect the treatment. For example: unsatisfactory effective nebulization time will lead to a negative impact on the inhaled amount of aerosolized medicine for patients within a certain period of time. This patent application provides a microstructure access module capable of achieving the above-mentioned MMAD and spray duration. More conclusions will be described in detail later.

3A-3B are examples of a microstructured access module 1, which conforms to some embodiments described in this patent application.

FIG. 3A is a top view of a microstructured via module microstructured via module 1 , which conforms to some embodiments described in this patent application.

Microstructure access module The microstructure access module 1 includes an upper cover 20 and a plate body 10 (covered by the upper cover 20, not shown), and the combination of the foregoing forms a chamber containing a filter structure. A liquid (not shown) enters the chamber through the inlet 102 and is released at the outlet 104 in the form of an aerosol. The filtering structure ensures that the aerosol 50 has the above-mentioned characteristics and is suitable for human inhalation therapy. For example, the aerosol 50 has the aforementioned MMAD and nebulization duration disclosed herein.

Figure 3B is a cross-sectional view of the microstructure access module 1 along the XX' line shown in Figure 3A, as follows, the microstructure access module 1 includes a plate body 10, an upper cover 20, and an inlet 102 and an outlet 104 for liquid to flow through, In addition, the plate body 10 and the upper cover 20 form a chamber 202 , and the chamber 202 includes a filter structure (omitted to make the chamber more clear) to guide the flow direction of the liquid or change the flow rate. The filtering structure may or may not be in contact with the above-mentioned plate body 10 and the upper cover 20, for example: the filtering structure may be a combination of protrusion rows 52, micropillars 4, protrusion walls 5 and protruding from the plate body 10. With the filtering structure of this structure, the aerosol device 50 has a specific MMAD and spray duration disclosed here.

4A-4C are top views of the microstructure access module 1, which are consistent with some embodiments described in this patent application.

Please refer to FIG. 4A , which discloses a microstructure access module 1 . The microstructure access module 1 includes a plate body 10, which can be made of silica gel and has dimensions: a width of about 2.5mm, a length of about 2mm, and a depth of about 700um. The plate body 10 is covered with a glass cover 20 (not shown in the figure), with a width of about 2.5mm, a length of about 2mm, and a depth of about 675um. The size of the plate body 10 corresponds to the upper cover 20 to form a cavity. In addition, the plate body 10 is combined with the upper cover 20 (not shown), and its opposite ends are defined as an inlet 102 and an outlet 104 . There are two side walls 108 between the inlet 102 and the outlet 104, and the distance between the side walls 108 is the width of the plate body 10. The liquid medicine 912 (not shown) enters the chamber from the inlet 102, and the generated aerosol 50 The chamber exits through outlet 104. The inlet 102 has a width of 2 mm, which is wider than the outlet 104 . The liquid medicament 912 flows in the chamber along a general direction from the inlet 102 to the outlet 104 . The liquid flow direction of the liquid medicament 912 in the access module is substantially perpendicular to the inlet 102, and is defined as A-A'. At least part of the liquid medicament 912 flows along the inclined wall 106 of the access module 1, causing the liquids to confluence and collide with each other, or preferably the confluence angle is about 90°. According to the above results, an aerosol 50 for inhalation by the patient is thus produced.

The plate body 10 further includes a central pillar 2 , spacer blocks 3 , micropillars 4 and protruding walls 5 . The microcolumns 4, spacer blocks 3 and protruding walls 5 are arranged to form the filter structure of the microstructure passage module 1, and the spacer blocks 3, protruding walls 5, microcolumns 4 and central column 2 protrude in a direction transverse to the liquid flow. In some embodiments, the spacer blocks 3 are arranged in multiple rows at the entrance 102 , and the distance between two adjacent spacer blocks 3 is twice the width of the channel 18 . Each spacer block 3 has a rectangular cross section, a width of about 50um, and a length of about 200um. In general, the spacer block 3 is used to initially filter the liquid medicament 912 entering the chamber and divide it into separate passages 18 .

In some embodiments, these components can be formed as part of the board body 10 by etching the microstructured via module 1 . In some embodiments, the plate body 10 is etched to a depth of about 5-6 um to integrally form some of the aforementioned components, and the depth covers a manufacturing tolerance of 1 um. It should be noted that the manufacturing method of the plate body 10 is not limited thereto. The plate body 10 can be made by other methods known in the related art, such as molding, welding or printing. Subsequent texts will further describe other features and structures of the overall assembly.

Referring to FIG. 4B , the central post 2 protrudes from the plate body 10 and is close to the outlet 104 . The shape of the central pillar 2 is nearly spherical, and its particle size is about 150um. The central column 2 occupies a considerable part of the area close to the outlet 104, so that liquid can only flow towards the outlet 104 through the two narrow channels 15 between the central column 2 and the inclined wall 106. The narrow channel 15 is at least partly continuous and longitudinal, in other words partly inclined walls 106 parallel to the corresponding central column 2 area. The above structure will cause the liquid to flow in opposite directions, that is, flow along the two opposite narrow channels 15 . In other words, the microstructure access module 1 can be understood as including two outlets 104 for aerosolization. Accordingly, the opposing liquid jets sprayed out of the two narrow channels 15 meet outside the channel module 1 near the outlet 104 and form the aerosol 50 . The size of the central column 2 is such that the width W of each narrow channel 15 is between about 6.7-8.3 um, more preferably, the width W of the narrow channel 15 is between about 7-8 um. It is worth noting that, here, the manufacturing tolerance of the distance D and the width W is about ±0.3um. In a particular embodiment, the width W refers to the distance between the inclined wall 106 and the central column 2, the measurement of which is shown in FIG. 4B.

Referring to Figures 4A and 4B, the plate body 10 further includes a protruding wall 5 disposed on the entire width of the plate body 10, and the filter structure of the present invention further includes this protruding wall 5, which is longitudinal and parallel to the liquid flow direction A-A' . Between each parallel protruding wall 5 is a channel 18 through which liquid medicine 912 can flow. The liquid flows in the direction AA' in the plurality of channels 18 . The width of the channel 18 is about 77um, and the typical width of the raised wall 5 is about 22um.

In some embodiments, for the unfiltered liquid medicament 912 entering the microstructured passage module 1, the space between the two raised walls 5 acts as a filter, for example, any particles with a size larger than the width of the passage 18 will be filtered by the space. blocked and filtered out. The protruding wall 5 further guides the flow direction of the liquid, so that the liquid flows more uniformly along the direction AA', thereby reducing turbulent flow.

In some embodiments, as shown in Figure 4C, the raised wall 5 is discontinuous. For example, a plurality of protrusion rows 52 are arranged to form the protrusion wall 5 . In particular, there is a space between two adjacent rows of protrusions 52, and the liquid flowing between the channels 18 will flow laterally through the gaps between the rows of protrusions 52. What is important is that all the technical features disclosed in this patent application for the protruding wall 5 are applicable to both continuous and discontinuous protruding walls 5 . In other embodiments, only the micropillars 4 are used without the raised walls 5 to provide the filtering function.

As shown in FIGS. 4A-4C , the micropillars 4 are circular and evenly distributed. The above arrangement forms a filter structure of a symmetrical pattern. Therefore, the symmetrical liquid flow is formed by the protruding wall 5 and the micro-column 4 to reduce the chance of turbulent flow in the chamber and also affect the effect of aerosolization. The micropillar 4 is a micron-sized component protruding from the plate body 10, and its height is about 5-6 um. The distance between the micropillars 4 is D, and the distance D is about 6.7-8.3um. More preferably, the distance D is about 7-8um. The distribution of the micropillars 4 provides for filtering the liquid into tiny particles, or increasing the flow resistance between the liquid medicine 912 . Therefore, the flow rate of liquid in the chamber is reduced. However, in some embodiments, the plate body 10 includes the protruding walls 5 and the micropillars 4 , but the micropillars 4 do not exist between the narrow channels 15 .

Referring to FIGS. 4A to 4C , the protruding wall 5 starts from the inlet 102 and extends toward the outlet 104 . The protruding wall 5 may or may not extend beyond the junction of the side wall 108 and the inclined wall 106 . In addition, the protruding wall 5 may also not start from the entrance 102 . In one example, the protruding wall 5 starts at a distance from the entrance 102 . The micropillars 4 occupy at least part of the passage 18 . Not only that, the microcolumns 4 occupy the area of the plate body 10 close to the outlet 104, and in the embodiments where the protruding wall 5 is not used for filtering or the protruding wall 5 is discontinuous, the microcolumns 4 are evenly distributed on the plate body 10. The term "occupancy" as used herein means that the microcolumns 4 exist around the plate body 10 but do not completely block the liquid flow. In some embodiments, the plate body 10 may be considered to include a first area and a second area, and the first area is closer to the entrance 102 than the second area. Furthermore, in some embodiments, the channel 18 is located in the first area and there is no protruding wall 5 in the second area, and the micropillars 4 occupy at least the second area, and a part, but not all, of the first area.

The following will focus on Table 1 below, which provides the droplet size as MMAD as measured by Next Generation Impactor (NGI). (Please refer to USP 36(601) Aerosols, Nasal Sprays, Metered-Dose Inhalers, AND Dry Powder Inhalers for aqueous solution). In the present disclosure, in the pressurized liquid, the distance D and the width W are specially designed so that the generated aerosol can have a predetermined MMAD and spray duration.

Table I

Table 1 reveals the measurement results (n=3), the MMAD of Aerosol 50 is less than about 5.5um. Or preferably, the MMAD of the aerosol is about 4-5um. In addition, the spray duration of the above-mentioned aerosol is less than 1.6 seconds. Or preferably, the above-mentioned spray duration is about 1.2-1.6 seconds. Or more preferably, the above-mentioned spray duration is about 1.4-1.6 seconds. Correspondingly, the spray speed of the aerosol sprayed at the outlet 104 is about 169˜175 m/s. Table 1 further provides a comparison of fine particle fraction (FPF) less than 5 microns in the pressurized liquid. In one embodiment, the proportion of droplets smaller than 5 microns is less than 50%. Or preferably, the above ratio is between 35% and 45%.

In order to achieve the above results, the distance D and the width W need to be specially designed. In some embodiments, the width W is between about 7-8 um and the distance D is between about 7-8 um. Or preferably, one of the width W and the distance D is less than 8 um and/or the other of the width W and the distance D is greater than 7 um. The above-mentioned structural design is beneficial for producing MMAD less than 5.5um and the spray duration is about 1.5-1.6 seconds, as mentioned above, so as to produce the ideal particle size and mist for delivering the drug to the patient's lungs.

In other words, the patient can inhale a fixed dose of aerosol with a desired particle size each time the aerosolizer 90 is operated. However, the present patent application is not limited to the description in the text, that is, any combination of the aforementioned width and distance D appearing in the specific range of the aforementioned Table 1 falls within the scope of this patent application. In addition, as described above, the present disclosure is effective for generating an aerosol with a desired MMAD and nebulization duration.

However, liquids with specific characteristics are relevant to the operation of the aerosolizer 90 and the desired results. Specifically, the aerosolizer 90 delivers less than 20 ul of liquid with a pressure of at least 50 bar to generate a therapeutically effective aerosol without propellants. To produce an effective therapeutic effect, the aerosol must have the properties disclosed herein. For this purpose, the liquid itself and its environment must be controlled.

In certain embodiments, the liquid composition does not contain propellant gas. Further, the liquid composition contains pharmaceutically active ingredients, stabilizers and preservatives. The active pharmaceutical ingredients are selected from betamimetics, anticholinergics, antiallergics, antihistamines and/or steroids or combinations thereof. For example, the pharmaceutically active ingredient may be selected from Albuterol Sulfate, Ipratropium Bromide, Tiotropium, Olodaterol, Budesonide, Formoterol, Fenoterol, etc. The ideal concentration of the active ingredient in the solution is 0.001-2g/100ml. A suitable stabilizer may be ethylenediaminetetraacetic acid (EDTA, ethylenediamine tetraacetic acid) at a concentration of 0.001-1 mg/ml in the solution, specifically, the concentration is less than about 0.5 mg/ml, and more preferably, the concentration is less than About 0.25mg/ml. A suitable preservative may be Benzalkonium Chloride. In addition, the pH value of the solution composition needs to be adjusted to a specific range, so the solution composition may include citric acid and hydrochloric acid. In certain preferred embodiments, the composition of the liquid may be 0.22-023 mg/ml of Tiotropium Bromide or its analog, 0.08-0.12 mg/ml of Benzalkonium (Benzalkonium) or its analog And 0.08 ~ 0.12 mg / ml of EDTA or its analogues. In addition, the pH value is between 2.7 and 3.1. The acidic pH is used to stabilize the composition and to the extent that the desired dosage is delivered. In addition, in certain preferred embodiments, the liquid has a low viscosity (about 0.88 cP) at room temperature, and the surface tension of the liquid is in the range of about 43-48 dyne. In other embodiments, the liquid is aerosolized to form a propellant-free aerosol for administration to the patient's lungs.

As shown in FIG. 2 , the liquid is stored in the storage container 908 and then delivered to the aerosolizer 90 . It is important that the liquid system does not contain any unsuitable ingredients or drug properties that could cause damage to or reaction to the aerosolizer 90 or storage container 908 . For example, the liquid may be a non-alcoholic solution and thus stable in storage in the container. Furthermore, the effective amount of the pharmaceutical active ingredient and the ideal concentration of the stabilizer can avoid damage or corrosion of the device, for example: if EDTA is used, its concentration in the solution composition needs to be optimized, a high concentration of EDTA will increase the solution channel of the nozzle Opportunities for crystallization to form, resulting in clogging or obstruction.

In addition to the above, the design combination of the specific structure of the microstructure access module 1 and the selection of the liquid composition all enable the aerosolizer 90 to generate an aerosol with a predetermined MMAD and a spray duration in a wider temperature range. Next, the following will discuss Table II below.

Table II

Table 2 shows the effects of the specially structured microstructure access module 1 of the present disclosure under different operating temperatures. From the above, it can be seen that the gas atomizer (n=3) can be operated at an operating temperature of about 4-25 degrees Celsius. In one example, the storage container containing the medicament is stored in a refrigerator, and the storage container is kept at an environment of 4 degrees Celsius before operation. As shown in Table 2, the microstructure channel module 1 in the present disclosure can generate aerosol with similar characteristics at 4-25 degrees Celsius. In other words, the specially structured microstructure channel module 1 in the present disclosure can generate ideal aerosol under harsh environment. Patients benefit because aerosol inhalation therapy can be performed in a greater variety of settings. Additionally, within this operating temperature range, the aerosolizer becomes more suitable for liquid medicaments with specific liquid viscosities. In certain embodiments, the viscosity of the medicament solution is adjusted to about 0.5-3 cP. In certain preferred implementations In one example, the viscosity ranges from about 0.8 to 1.6 cP. High viscosity may affect the average particle size of the aerosol and the duration of the spray, so it is best to keep the viscosity low. In addition, the configuration of the microstructure access module 1 in the present disclosure makes it more suitable for liquid medicines with specific surface tension. In some embodiments, the surface tension of liquid medicines ranges from about 20 to 70 mN/ m, or more preferably, between about 25-50 mN/m. Lower surface tension can provide better diffusion ability of the drug, thus increasing the deposition of aerosol on the lung surface, improving the effectiveness of the drug and inhalation therapy.

Therefore, under the conditions of the above-mentioned ideal liquid composition, the microstructure channel module 1 has a width W between about 6.7-8.3um and a distance D between about 6.7-8.3um, and a viscosity range of 0.5-3cP (operating temperature is about 4-25 degrees Celsius), can produce a better aerosol, its MMAD is less than about 5.5um, or better, between 4-5.5um, and the spray duration is less than 1.6 seconds, or better, between 1.4 ~1.6 seconds, and the ratio of droplets smaller than 5 microns is less than 50%. Or more preferably, the above ratio is between 25% and 40%. Under these conditions, aerosol inhalation therapy is more effective.

Function and effect of embodiment

The utility model is a microstructure access module 1 specially structured to generate ideal aerosol in harsh environments, and patients benefit a lot because their aerosol inhalation therapy can be operated in more diverse environments .

To sum up, the microstructure access module 1 provided by the present invention is easier to manufacture due to the reduced complexity of the fabric and its micron-sized components. The finished device can deliver a more precise dose of aerosol with ideal MMAD and spray duration each time the aerosolizer is operated.

The above embodiments are preferred cases of the present utility model, and are not intended to limit the protection scope of the present utility model.

Claims (14)

1. one be applied to aerosolization device micro-structure nozzle, 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 the aerosol of scheduled MMAD；

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

2. micro-structure nozzle as described in claim 1, which is characterized in that at least one described width W be less than 8um or described away from It is less than 8um from D.

3. micro-structure nozzle as claimed in claim 2, which is characterized in that at least one described width W be greater than 7um or described away from It is greater than 7um from D.

4. micro-structure nozzle as described in claim 1, which is characterized in that the scheduled MMAD is less than 5.5um.

5. micro-structure nozzle as described in claim 1, which is characterized in that the aerosolization device further has the spraying duration It is 1.2~1.6 seconds.

6. micro-structure nozzle as described in claim 1, which is characterized in that ratio of the drop size of the aerosol less than 5 microns Example is less than 50%.

7. micro-structure nozzle as described in claim 1, which is characterized in that ratio of the drop size of the aerosol less than 5 microns Example is between 35~45%.

8. micro-structure nozzle as described in claim 1, which is characterized in that the section of the microtrabeculae is circle.

9. micro-structure nozzle as claimed in claim 8, which is characterized in that the microtrabeculae system is evenly distributed.

10. micro-structure nozzle as described in claim 1, which is characterized in that the viscosity of the liquid is between 0.5~3cP.

11. one be applied to aerosolization device micro-structure nozzle, 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

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 liquid flows through, and the arrow path width is W；

Wherein, the liquid flows through the chamber to the outlet from the entrance, and the filter arrangement increases the liquid Flow resistance generates the aerosol that MMAD is less than 5.5um；

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

12. micro-structure nozzle as claimed in claim 11, which is characterized in that the width W is between 7~8um.

13. micro-structure nozzle as claimed in claim 12, which is characterized in that the viscosity of the liquid is less than 3cP.

14. micro-structure nozzle as claimed in claim 13, which is characterized in that the viscosity of the liquid is between 0.8~1.6cP.