CN116407715A - A kind of atomization module, atomizer and atomization method thereof - Google Patents
A kind of atomization module, atomizer and atomization method thereofDownload PDFInfo
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- CN116407715A CN116407715ACN202111678175.4ACN202111678175ACN116407715ACN 116407715 ACN116407715 ACN 116407715ACN 202111678175 ACN202111678175 ACN 202111678175ACN 116407715 ACN116407715 ACN 116407715A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
- A61M11/04—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised
- A61M11/041—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised using heaters
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
- A61M11/02—Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0021—Mouthpieces therefor
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Abstract
Translated fromChinese
Description
Translated fromChinese技术领域technical field
本发明涉及医疗器械技术领域，尤其涉及一种雾化模块、雾化器及其雾化方法。The invention relates to the technical field of medical devices, in particular to an atomization module, an atomizer and an atomization method thereof.
背景技术Background technique
雾化器用于将吸入液体制剂转换为可供患者吸入的水雾实现直接对肺部给药的目的。雾化器自身的雾化性能和用户对雾化器的使用技巧影响其药物递送效果。射流雾化器是国内医院最常见的雾化装置，具有使用简单、适用药物品种广、雾化剂量高、可同时雾化多种药物的优点。但对应地也具有雾化时间长、药物利用率低、雾化效果波动较大、依赖气源或电源、使用时需保持雾化杯垂直等缺点。因此近年来很多新型雾化装置在雾化速率、药物利用率和便携性等方面做了大量的优化尝试。Nebulizers are used to convert inhaled liquid preparations into water mist that can be inhaled by patients to achieve the purpose of direct lung administration. The atomization performance of the nebulizer itself and the user's skill in using the nebulizer affect its drug delivery effect. Jet nebulizer is the most common atomizing device in domestic hospitals, which has the advantages of simple use, wide variety of applicable drugs, high atomized dose, and can atomize multiple drugs at the same time. However, correspondingly, it also has disadvantages such as long atomization time, low drug utilization rate, large fluctuations in atomization effect, dependence on air source or power supply, and the need to keep the atomization cup vertical when in use. Therefore, many new atomization devices have made a lot of optimization attempts in terms of atomization rate, drug utilization and portability in recent years.
专利《Atomising Nozzle and Filter and Spray Generation Device》(US005472143)公开了一种雾化装置和雾化机制，通过压迫药物溶液通过微喷嘴形成具有特定交叉角度的两股微液柱后，通过微液柱在空气中的碰撞将药物溶液转换为供吸入的微细水雾。与传统气雾剂相比，输出水雾的喷射速度更慢，药物在口喉部的残留量更少，同时对患者的手口协调性要求更低，可显著提升药物在肺部的沉降比例。该装置的雾化效果由微液柱的直径和碰撞角度决定，对喷嘴内部微通道的形态和精度要求极高，因此工艺难度大、加工成本高。同时该装置每喷仅可雾化10-15μL的药物溶液，仅适用于需要小剂量给药的药物品种。The patent "Atomising Nozzle and Filter and Spray Generation Device" (US005472143) discloses an atomization device and an atomization mechanism. After forming two micro-liquid columns with a specific crossing angle by pressing the drug solution through the micro-nozzle, the micro-liquid column passes through the micro-liquid column The collisions in the air convert the drug solution into a fine mist for inhalation. Compared with traditional aerosols, the spray speed of the output water mist is slower, and the residual amount of drugs in the mouth and throat is less. At the same time, it requires less hand-mouth coordination of patients, which can significantly increase the sedimentation ratio of drugs in the lungs. The atomization effect of this device is determined by the diameter and collision angle of the micro-liquid column, and the shape and precision of the micro-channel inside the nozzle are extremely required, so the process is difficult and the processing cost is high. At the same time, each spray of the device can only atomize 10-15 μL of drug solution, which is only suitable for drug varieties that need to be administered in small doses.
专利《Aerosol and a Method and Apparatus for Generating an Aerosol》(US5743251)公开了一种雾化装置和雾化机制，使药物溶液流经加热毛细管，溶液在毛细管内即受热完全汽化，药物溶液转换为气态后体积变化导致的压力上升使蒸发气体加速喷出，喷出后蒸汽预冷快速凝结生成供吸入的微细水雾。与现有雾化机制相比，具有输出水雾的微细粒子比例极高，雾化输出不依赖患者操作,可雾化药物剂量大，不依赖抛射剂或压缩空气等优点。但该雾化机制输出水雾主要由1μm以下液滴构成，当前吸入理论一般认为2-5μm是理想的吸入给药粒径，2μm以下的微粒可能随患者呼气被呼出，给药效果可能受影响。进一步的，专利《Effective Delivery of Nanoparticles and Micrometer-sizedPharmaceutical Aerosols to the Lung Through Enhanced Condensational growth》(US 8479728)公开了一种新的雾化吸入装置，药物溶液经加热毛细管蒸发喷出含药气雾后，与另外一路蒸汽混合后再由患者吸入。蒸汽水雾提供湿度更高的吸入气流，使含药气雾的所含<1μm的微粒在吸入过程中可冷凝增长至2μm以上，提升药物在肺部的沉降比例。但该结构的构成更为复杂，新增的蒸汽加湿通路需更多的空间，因此更适合在病房内的住院患者使用。同时雾化时间较慢，且需连续吸入高湿度空气，可能对呼吸道患者带来额外的痰液负担。The patent "Aerosol and a Method and Apparatus for Generating an Aerosol" (US5743251) discloses an atomization device and an atomization mechanism, so that the drug solution flows through the heating capillary, and the solution is heated and completely vaporized in the capillary, and the drug solution is converted into a gaseous state The pressure increase caused by the volume change after the injection accelerates the ejection of the evaporated gas, and after the ejection, the steam is pre-cooled and quickly condenses to form a fine water mist for inhalation. Compared with the existing atomization mechanism, it has a very high proportion of fine particles in the output water mist, the atomization output does not depend on the operation of the patient, the dose of nebulized medicine is large, and it does not rely on propellants or compressed air. However, the water mist output by this atomization mechanism is mainly composed of droplets below 1 μm. The current inhalation theory generally believes that 2-5 μm is the ideal particle size for inhalation and administration. Particles below 2 μm may be exhaled with the patient’s exhalation, and the drug delivery effect may be affected. Influence. Further, the patent "Effective Delivery of Nanoparticles and Micrometer-sizedPharmaceutical Aerosols to the Lung Through Enhanced Condensational growth" (US 8479728) discloses a new nebulization inhalation device. , mixed with another stream of steam and then inhaled by the patient. The steam water mist provides an inhaled airflow with higher humidity, so that the particles <1 μm contained in the drug-containing aerosol can condense and grow to more than 2 μm during the inhalation process, increasing the sedimentation ratio of the drug in the lungs. However, the composition of the structure is more complicated, and the newly added steam humidification channel requires more space, so it is more suitable for inpatients in the ward. At the same time, the nebulization time is slow, and high-humidity air needs to be inhaled continuously, which may bring additional sputum burden to respiratory patients.
可以看到，虽然现有技术的雾化装置在获得2-5微米雾化效果的同时提升了给药效率，但依然存在雾化装置结构复杂、成本高、使用不便等的缺陷。It can be seen that although the atomization device in the prior art improves the drug delivery efficiency while obtaining the atomization effect of 2-5 microns, there are still defects such as complex structure, high cost, and inconvenient use of the atomization device.
发明内容Contents of the invention
为了解决上述问题，本发明提供了一种基于新型雾化机制的雾化模块及雾化器，雾化速率快、结构易于实现，并可支持大剂量药物的雾化，克服了现有雾化器存在雾化时间长、雾化结构复杂成本高、仅能雾化小剂量药物的缺陷。In order to solve the above problems, the present invention provides an atomization module and an atomizer based on a new atomization mechanism. The device has the defects of long atomization time, complicated atomization structure and high cost, and can only atomize small doses of medicine.
为了实现上述发明目的，本发明的第一方面提供了一种雾化器的雾化模块，包括耐压溶液腔、压力组件、加热组件和密封喷嘴；In order to achieve the purpose of the above invention, the first aspect of the present invention provides an atomization module of an atomizer, including a pressure-resistant solution chamber, a pressure component, a heating component and a sealing nozzle;
所述压力组件与耐压溶液腔连接，压力组件可提高耐压溶液腔内压力；The pressure component is connected to the pressure-resistant solution cavity, and the pressure component can increase the pressure in the pressure-resistant solution cavity;
所述密封喷嘴与耐压溶液腔上的出液口连接，所述密封喷嘴包括过渡段和喷雾片，喷雾片上设置有对内封闭的盲孔，所述过渡段、盲孔和出液口联通；所述盲孔超过承压后由内向外打开，待雾化液体自盲孔处喷出；所述耐压溶液腔、过渡段和盲孔的内径依次减小；The sealing nozzle is connected to the liquid outlet on the pressure-resistant solution chamber, the sealing nozzle includes a transition section and a spray sheet, and the spray sheet is provided with an internally closed blind hole, and the transition section, the blind hole and the liquid outlet are communicated ; The blind hole is opened from the inside to the outside after exceeding the pressure, and the atomized liquid is sprayed from the blind hole; the inner diameters of the pressure-resistant solution chamber, the transition section and the blind hole are sequentially reduced;
所述加热组件可对耐压溶液腔加热。The heating component can heat the pressure-resistant solution chamber.
优选的，所述耐压溶液腔的内径为过渡段内径的2-3倍。Preferably, the inner diameter of the pressure-resistant solution chamber is 2-3 times the inner diameter of the transition section.
优选的，所述盲孔内径为0.03-0.3mm，过渡段内径为盲孔内径的1.5倍以上。Preferably, the inner diameter of the blind hole is 0.03-0.3 mm, and the inner diameter of the transition section is more than 1.5 times the inner diameter of the blind hole.
优选的，所述盲孔厚度为0.005-0.02mm。Preferably, the thickness of the blind hole is 0.005-0.02mm.
优选的，所述密封喷嘴外还设置有紧固件，紧固件将密封喷嘴紧固在耐压溶液腔开口一端，所述紧固件上设置有覆盖在盲孔上的开孔。Preferably, a fastener is provided outside the sealing nozzle, the fastener fastens the sealing nozzle to one end of the opening of the pressure-resistant solution chamber, and the fastener is provided with an opening covering the blind hole.
优选的，所述过渡段全部或部分设置在出液口内。Preferably, all or part of the transition section is set in the liquid outlet.
优选的，所述加热组件包括热源模块、热传递模块和温度控制模块；所述热源通过热传递模块向耐压溶液腔传递热量，所述温度控制模块用于控制耐压溶液腔和/或热传递模块的温度。Preferably, the heating assembly includes a heat source module, a heat transfer module and a temperature control module; the heat source transfers heat to the pressure-resistant solution chamber through the heat transfer module, and the temperature control module is used to control the pressure-resistant solution chamber and/or heat Transfer the temperature of the block.
优选的，所述热传递模块全部或部分包覆耐压溶液腔，或全部或部分包覆耐压溶液腔和密封喷嘴内侧。Preferably, the heat transfer module completely or partially covers the pressure-resistant solution chamber, or completely or partially covers the pressure-resistant solution chamber and the inner side of the sealing nozzle.
优选的，所述热源模块被热传递模块全部或部分包覆。Preferably, the heat source module is fully or partially covered by the heat transfer module.
优选的，所述密封喷嘴包括若干个盲孔，若干个盲孔在对应过渡段内径的范围内排布。Preferably, the sealing nozzle includes several blind holes, and the several blind holes are arranged within a range corresponding to the inner diameter of the transition section.
本发明的第二方面提供了一种雾化器，包括上述技术方案所述的雾化模块、贮药模块、控制模块、定量给液模块和动力模块，所述控制模块分别与雾化模块、定量给液模块和动力模块连接以控制雾化器雾化。The second aspect of the present invention provides an atomizer, including the atomization module described in the above technical solution, the drug storage module, the control module, the quantitative liquid supply module and the power module, the control module is respectively connected with the atomization module, The dosing module and the power module are connected to control the atomization of the nebulizer.
优选的，所述雾化器还包括可感应吸气气流的气流传感器。Preferably, the nebulizer further includes an airflow sensor capable of sensing inspiratory airflow.
优选的，定量给液模块与所述雾化模块中的压力组件集成在一个结构中。Preferably, the quantitative liquid supply module and the pressure component in the atomization module are integrated into one structure.
本发明的第三方面提供了一种雾化方法，利用前述技术方案所述雾化模块或上述技术方案所述雾化器实现，其步骤包括：The third aspect of the present invention provides an atomization method, which is realized by using the atomization module described in the aforementioned technical solution or the atomizer described in the aforementioned technical solution, and the steps include:
S1.待雾化液体进入耐压溶液腔后，对耐压溶液腔增压并加热，使雾化液体在耐压溶液腔内温度超过其标准大气压下的沸点10℃以上；S1. After the atomized liquid enters the pressure-resistant solution chamber, pressurize and heat the pressure-resistant solution chamber, so that the temperature of the atomized liquid in the pressure-resistant solution chamber exceeds its boiling point at standard atmospheric pressure by more than 10°C;
S2.继续对耐压溶液腔加压，直至耐压溶液腔内的待雾化液体压力高于密封喷嘴中盲孔的预设压力时，盲孔发生形变破裂，待雾化液体自形变的盲孔喷出并雾化。S2. Continue to pressurize the pressure-resistant solution chamber until the pressure of the liquid to be atomized in the pressure-resistant solution chamber is higher than the preset pressure of the blind hole in the sealing nozzle. The hole is sprayed out and atomized.
优选的，所述待雾化液体选自溶液或混悬液。Preferably, the liquid to be atomized is selected from a solution or a suspension.
优选的，步骤S1还包括在增压、加热前向待雾化液体添加溶剂、耐压保护剂和耐热保护剂中的一种或多种。Preferably, step S1 further includes adding one or more of a solvent, a pressure-resistant protective agent and a heat-resistant protective agent to the liquid to be atomized before pressurization and heating.
与现有技术相比，本发明的有益效果：Compared with prior art, the beneficial effect of the present invention:
本发明提供的雾化模块包括耐压溶液腔、压力组件、加热组件和密封喷嘴，本发明通过压力组件和加热组件对耐压溶液腔内的待雾化液体进行加压和加热，使待雾化液体温度超过标准大气压下沸点(以下简称“过热状态”)后仍处于液态，当待雾化液体持续加压至超过喷雾片上盲孔承压范围后，盲孔发生形变破裂，待雾化液体经过连续缩窄的过渡段和盲孔破裂开口后向外射出形成连续微液柱，过热状态下的微液柱由于环境压力显著降低触发“闪蒸”现象，在极短的时间内剧烈沸腾，沸腾气泡生成导致的体积变化以及气泡膜裂产生的瞬时剪切力使微液柱表面发生剧烈波动，进而分散破裂形成适宜吸入式给药的微液滴。本发明采用了与现有技术不同的雾化机制，利用本发明提供的雾化模块进行雾化，不同剂量下喷雾质量特征稳定，输出液滴的质量空气动力学中位粒径始终分布在2-5μm范围内，可实现大剂量雾化给药。The atomization module provided by the present invention includes a pressure-resistant solution chamber, a pressure assembly, a heating assembly and a sealed nozzle. The present invention pressurizes and heats the liquid to be atomized in the pressure-resistant solution chamber through the pressure assembly and the heating assembly, so that the liquid to be atomized After the temperature of the atomized liquid exceeds the boiling point at standard atmospheric pressure (hereinafter referred to as "superheated state"), it is still in a liquid state. When the liquid to be atomized is continuously pressurized to exceed the pressure range of the blind hole on the spray sheet, the blind hole is deformed and ruptured, and the liquid to be atomized After passing through the continuously narrowed transition section and the rupture opening of the blind hole, it shoots out to form a continuous micro-liquid column. The micro-liquid column in the overheated state triggers the "flash" phenomenon due to the significant drop in ambient pressure, and boils violently in a very short time. The volume change caused by the generation of boiling bubbles and the instantaneous shear force generated by the rupture of the bubble film make the surface of the micro-liquid column fluctuate violently, and then disperse and rupture to form micro-droplets suitable for inhalation administration. The present invention adopts an atomization mechanism different from that of the prior art. The atomization module provided by the present invention is used for atomization. The spray quality characteristics are stable under different doses, and the mass aerodynamic median particle size of the output droplets is always distributed within 2 In the range of -5μm, large doses of nebulized drug delivery can be realized.
与传统射流雾化器相比，本发明所述雾化模块的雾化速率更快，可改善患者依从性，溶液残留量更少药物利用率更高，使用时不需要将雾化器保持在特定姿态。与气雾剂相比，喷雾输出不依赖抛射剂，对环境友好，不存在因环保要求需调整药物处方的风险。与新型雾化装置相比，每喷可雾化溶液的容量范围大，根据需要即可递送微剂量药物也可递送大剂量药物，适用范围更广。Compared with the traditional jet nebulizer, the nebulization module of the present invention has a faster nebulization rate, which can improve patient compliance, has less residual solution and higher drug utilization, and does not need to keep the nebulizer at specific posture. Compared with the aerosol, the spray output does not depend on the propellant, which is friendly to the environment, and there is no risk of adjusting the drug prescription due to environmental protection requirements. Compared with the new atomization device, each spray can have a large volume range of nebulizable solution, and can deliver both micro-dose and large-dose medicaments according to needs, and has a wider application range.
同时本发明所采用的喷嘴部件结构简单，不依赖高精度的微米级特征或结构来实现雾化效果，工艺难度和加工成本低，更便于控制最终药品的价格。At the same time, the structure of the nozzle part used in the present invention is simple, does not rely on high-precision micron-level features or structures to achieve the atomization effect, the process difficulty and processing cost are low, and it is easier to control the price of the final drug.
附图说明Description of drawings
为使本发明的目的、技术方案和优点更加清楚，下面将对本发明的技术方案进行详细的描述。显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动的前提下所得到的所有其它实施方式，都属于本发明所保护的范围。In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be described in detail below. Apparently, the described embodiments are only some of the embodiments of the present invention, but not all of them. Based on the embodiments of the present invention, all other implementations obtained by persons of ordinary skill in the art without making creative efforts fall within the protection scope of the present invention.
图1为本发明一个具体实施方式中雾化模块的剖视图；Fig. 1 is a cross-sectional view of an atomization module in a specific embodiment of the present invention;
图2为本发明一个具体实施方式中雾化模块的雾化出口侧示意图；Fig. 2 is a schematic diagram of the atomization outlet side of the atomization module in a specific embodiment of the present invention;
图3为本发明一个具体实施方式中雾化模块的进液口侧示意图；Fig. 3 is a schematic diagram of the liquid inlet side of the atomization module in a specific embodiment of the present invention;
图4为本发明一个具体实施方式中雾化模块的部分结构展开示意图；Fig. 4 is a schematic diagram of partial structure expansion of the atomization module in a specific embodiment of the present invention;
图5为本发明一个具体实施方式中雾化模块的部分结构内径示意图；Fig. 5 is a schematic diagram of the inner diameter of a part of the structure of the atomization module in a specific embodiment of the present invention;
图6为本发明一个具体实施方式中雾化器的结构示意图；Fig. 6 is a schematic structural diagram of an atomizer in a specific embodiment of the present invention;
图7为实施例中额定条件下喷雾历经分布特征图；Fig. 7 is a characteristic diagram of distribution of spray under rated conditions in the embodiment;
图8为实施例中额定条件下微细粒子(＜5μm)比例分布图；Figure 8 is a distribution diagram of the proportion of fine particles (<5 μm) under rated conditions in the embodiment;
图9为实施例中不同雾化容量下输出水雾的雾化质量(n＝10)分布图；Fig. 9 is a distribution diagram of atomization quality (n=10) of output water mist under different atomization capacities in the embodiment;
其中，1为雾化模块，2为药物贮存模块，3为控制模块，4为定量给液模块，5为动力模块，11为耐压溶液腔，12为密封喷嘴，13为加热组件，14为压力组件，15为紧固件，111为出液口，112为进液口，121为过渡段，122为喷雾片，1221为盲孔，131为热源，132为热传递模块，1331为温度控制模块；151为开孔；d1为耐压溶液腔内径，d2为过渡段内径，d3为盲孔厚度。Among them, 1 is an atomization module, 2 is a drug storage module, 3 is a control module, 4 is a quantitative liquid supply module, 5 is a power module, 11 is a pressure-resistant solution chamber, 12 is a sealing nozzle, 13 is a heating component, 14 is a Pressure component, 15 is a fastener, 111 is a liquid outlet, 112 is a liquid inlet, 121 is a transition section, 122 is a spray sheet, 1221 is a blind hole, 131 is a heat source, 132 is a heat transfer module, 1331 is a temperature control Module; 151 is an opening; d1 is the inner diameter of the pressure-resistant solution cavity, d2 is the inner diameter of the transition section, and d3 is the thickness of the blind hole.
具体实施方式Detailed ways
下面将结合附图，对本发明的技术方案进行描述。显然，所描述的实施例仅是本申请一部分的实施方式，而不是全部的实施方式；并且附图中所示的结构仅仅是示意性的，并不代表实物。需要说明的是，基于本发明中的这些实施例，本领域普通技术人员所获得的所有其他实施例，都属于本申请保护的范围。The technical solutions of the present invention will be described below in conjunction with the accompanying drawings. Apparently, the described embodiments are only part of the implementations of the present application, but not all of them; and the structures shown in the drawings are only schematic and do not represent real objects. It should be noted that, based on these embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art belong to the protection scope of the present application.
在本发明中，所述“内侧”是指相对远离开孔或盲孔的一侧；所述“外侧”是指相对远离开孔或盲孔的一侧。In the present invention, the "inside" refers to the side relatively far away from the hole or blind hole; the "outside" refers to the side relatively far away from the hole or blind hole.
在本发明中，所述“过热温度”是指待雾化液体温度大于1个大气压下沸点时的温度；所述“过热状态”是指待雾化液体温度为过热温度且呈液态的状态；所述“过热度”是指过热温度超出待雾化液体在1个大气压下沸点的温度差。In the present invention, the "superheated temperature" refers to the temperature when the temperature of the liquid to be atomized is greater than the boiling point at 1 atmospheric pressure; the "superheated state" refers to the state where the temperature of the liquid to be atomized is the superheated temperature and is in a liquid state; The "degree of superheat" refers to the temperature difference between the superheat temperature and the boiling point of the liquid to be atomized at 1 atmospheric pressure.
在本发明中，所述“盲孔厚度”是指盲孔的凹槽底端至喷雾片外侧的距离，如图5所示的D3。In the present invention, the "blind hole thickness" refers to the distance from the bottom of the groove of the blind hole to the outside of the spray sheet, as shown in D3 in FIG. 5 .
如图1-5所示，本发明提供了一种雾化器的雾化模块1，包括耐压溶液腔11、密封喷嘴12、加热组件13和压力组件14。As shown in FIGS. 1-5 , the present invention provides an
本发明所述耐压溶液腔11用于承装待雾化液体，本发明通过加压待雾化液体在耐压溶液腔11中始终呈液态。本发明所述耐压溶液腔可以是任意形状的，如圆柱形、长方体、正方体、锥体或不规则的形状。在本发明中，所述耐压溶液腔11包括进液口112和出液口111，所述出液口111与密封喷嘴12连接，所述进液口112用于连接可输入待雾化液体的结构(例如定量给液模块4)。本发明对所述进液口和/或出液口的形状无特殊限定，在一些具体实施方式中，所述出液口111为圆形。The pressure-
在本发明的一些具体实施方式中，所述耐压溶液腔可以由于药物相容性好且热稳定高的材料制成，如高硼硅玻璃，这种情况下热传递模块不与待雾化溶液直接接触无相容性要求，可以是其他导热性更好或重量更轻的金属材质，例如铜合金或铝合金，也可以是其他导热性好的非金属材料例如陶瓷。在本发明的一些具体实施方式中，所述耐压溶液腔11的容量为0.03-0.2mL之间，优选的容量为0.05-0.1mL之间；在本发明的一些具体实施方式中，所述耐压溶液腔11的容量是可调节的。In some specific embodiments of the present invention, the pressure-resistant solution chamber can be made of materials with good drug compatibility and high thermal stability, such as high borosilicate glass. In this case, the heat transfer module is not connected with the There is no compatibility requirement for direct contact of the solution, and it can be other metal materials with better thermal conductivity or lighter weight, such as copper alloy or aluminum alloy, or other non-metallic materials with good thermal conductivity such as ceramics. In some specific embodiments of the present invention, the capacity of the pressure-
本发明所述密封喷嘴12包括过渡段121和喷雾片122，，喷雾片上设置有对内封闭的盲孔1221，所述过渡段121、盲孔1221和出液口111联通；所述盲孔1221超过承压后由内向外打开，待雾化液体自盲孔1221处喷出；所述耐压溶液腔11、过渡段121和盲孔1221的内径依次减小。密封喷嘴12与耐压溶液腔12配合使耐压溶液腔在一定压力范围内保持密闭，实现耐压溶液腔内的待雾化液体进行加压加热达到过热温度；盲孔1221是密封喷嘴12和耐压溶液腔12所形成的密闭空间中最薄弱的一处，因而待雾化液体的压力超过盲孔承压范围后，盲孔受压形变由内到外打开，待雾化液体自盲孔处喷出。由于待雾化液体喷出时的溶液冲破喷雾片上密封点后向外射出形成连续微液柱，此时过热液体由于环境压力恢复至标准大气压，对应沸点降至自身温度以下，触发闪蒸现象，在极短的时间内剧烈沸腾。沸腾气泡生成导致的体积变化和气泡膜裂产生的瞬时剪切力使微液柱表面发生剧烈波动，进而分散破裂生成供吸入的微液滴。The sealing
除待雾化液体自身的表面张力和热力学参数的固有特征外，本发明所述雾化模块输出的水雾质量主要由待雾化液体的“过热度”、喷出微液柱的初始直径和单喷剂量决定。其中过热度是雾化粒径的主要决定因素，过热度为0时不存在闪蒸现象，液体呈连续微液柱装喷出而不形成水雾。过热度大于10℃时，喷出微液柱开始分散为微细水雾，随过热度的上升输出水雾的空气动力学粒径对应缩小。初始微液柱直径决定输出水雾粒径的均匀性，初始液柱直径约小，存在闪蒸现象时喷雾的扩散角度越大，对应输出水雾的微细粒子比例越高。初始微液柱直径大小主要取决于盲孔1221的直径大小，初始微液柱的直径约为盲孔1221的2-3倍。In addition to the inherent characteristics of the surface tension of the liquid to be atomized and the thermodynamic parameters, the quality of the water mist output by the atomization module of the present invention is mainly determined by the "superheat" of the liquid to be atomized, the initial diameter of the ejected micro-liquid column and The dosage of single spray is determined. Among them, the degree of superheat is the main determinant of the atomized particle size. When the degree of superheat is 0, there is no flash evaporation, and the liquid is sprayed out in a continuous micro-liquid column without forming water mist. When the degree of superheat is greater than 10°C, the sprayed micro-liquid column begins to disperse into fine water mist, and the aerodynamic particle size of the output water mist decreases correspondingly as the degree of superheat increases. The diameter of the initial micro-liquid column determines the uniformity of the particle size of the output water mist. The initial diameter of the liquid column is approximately small, and the larger the spray diffusion angle is when there is a flash phenomenon, the higher the proportion of fine particles corresponding to the output water mist. The diameter of the initial micro liquid column mainly depends on the diameter of the
如图5所示，耐压溶液腔11、过渡段121和盲孔1221的内径依次减小，使得待雾化液体喷出前必须经过两次连续的缩窄压缩，起到提升局部压强，减少喷雾压力，减缓初始微液柱速度和控制喷雾持续时间的作用。在本发明的一些具体实施方式中，所述耐压溶液腔的内径D1为过渡段内径D2的2-3倍，优选为1.5倍。在本发明的一些具体实施方式中，所述盲孔内径为0.03-0.3mm，优选为0.05-0.15mm；过渡段内径D2优选为盲孔内径的1.5倍以上。在本发明中，所述盲孔的厚度D3通常薄于雾化模块的其他结构；在一些具体实施方式中，所述盲孔厚度可以0.005-0.02mm，优选为0.008-0.015mm。在本发明的一些具体实施方式中，所述盲孔1221可以由高分子材料制成，也可以是具有若干个高分子薄膜微孔的金属片。本发明所述的喷雾片或密封喷雾通常为一次性使用，形变后可打开禁锢件进行更换。As shown in Figure 5, the inner diameters of the pressure-
在本发明中，所述过渡段121和喷雾片122通常是一体成型的。在本发明的一些具体实施方式中，所述过渡段121全部或部分设置在进液口111内。在本发明的一些具体实施方式中，本发明的雾化模块11优选的还设置有紧固件15，紧固件15将密封喷嘴12紧固在耐压溶液腔开口一端，所述紧固件15上设置有覆盖在盲孔1221上的开孔151。过渡段121被压入紧固件的开孔区域，开孔边缘在过渡段外层边界和喷雾片间提供额外的指向圆心的锁紧力来进一步保证密封强度。一般设定的密封压力为0.1Mpa-0.8Mpa，优选的密封压力为0.2Mpa-0.5Map；上述压力为相对压力。在本发明的一些具体实施方式中，所述密封喷嘴可以由具有药物相容性和热稳定性的弹性材料制成，例如硅胶，或药物相容性良好的不锈钢材料如304、316或316L等。在本发明的一些具体实施方式中，所述开孔151的内径为过渡段121外径的0.7-1.1倍，优选为过渡段121外径的0.85-0.95倍。在本发明的一些优选实施方案中，所述过渡段121、开孔151为同心圆。In the present invention, the
在本发明的一些具体实施方式中，所述喷雾片上可以设置若干个盲孔1221，若干个盲孔1221以一定规律分布在过渡段内径对应的范围内，可在喷雾剂量不变时进一步减慢喷雾速度，减少吸入时患者口喉残留，提升给药效果，或配合增加喷雾压力获得进一步提升单喷剂量的效果，适用于更大剂量吸入给药的情形。In some specific embodiments of the present invention, several
本发明所述加热组件13用于对耐热溶液腔进行加热。本发明优选的，所述加热组件13包括热源131、热传递模块132和温度控制模块133。在本发明中，所述热源131为发热装置，热传递模块132用于将热源产生的热量传到至耐热溶液腔中，所述温度控制模块133用于温度控制。当热源131直接与耐热溶液腔11连接时，也可以省略热传递模块132,。待雾化液体在耐热溶液腔内需要达到过热温度，本发明进一步优选的，所述温度控制模块133包括温度传感器1331和温度控制器1332，温度传感器1331可设置在耐热溶液腔上或其内部，所述温度控制器1332可根据温度传感器1331反馈的温度数据对热源131进行调节和开闭，例如当温度传感器1331检测到耐热溶液腔温度超过预设温度上限时温度控制1332将热源131关闭；一般设定过热温度为110℃-180℃，优选的设置过热温度为120℃-150℃。在本发明中，所述温度传感器1331除了直接感应温度外，还可以通过感应其他参数间接探测温度，例如根据热源的电阻变化计算耐热溶液腔/热传递模块的温度。The heating assembly 13 of the present invention is used to heat the heat-resistant solution chamber. Preferably in the present invention, the heating assembly 13 includes a
在本发明的一些具体实施方式中，所述热源131可固定于热传递模块132上，被热传递模块132全部或部分包裹。在本发明的一些具体实施方式中，所述热传递模块132可全部或部分包裹耐热溶液腔11。在本发明中，所述热传递模块可以是药物相容性好的金属材质，例如不锈钢304、316、316L。在本发明的一些具体实施例中，热源可以是单头或多头的陶瓷热棒、不锈钢热棒，还可以是在外部缠绕热传递模块122的发热丝或编织成特定形状固定在热传递模块内部的发热丝。在本发明的一些具体实施例中，所述热源131的发热功率为2-50W。In some specific implementations of the present invention, the
本发明所述压力组件14用于控制耐压溶液腔内的压力，可以采用本领域已知的任何对液体增压结构。在本发明的一些具体实施方式中，所述压力组件为液泵。本发明所述压力组件还可以包括压力探测装置和/或独立的压力控制元件，根据预先设定或调节的方式对耐压溶液腔内进行增压或减压。The pressure component 14 of the present invention is used to control the pressure in the pressure-resistant solution chamber, and any liquid pressurization structure known in the art can be used. In some specific embodiments of the present invention, the pressure component is a liquid pump. The pressure assembly of the present invention may also include a pressure detection device and/or an independent pressure control element, which pressurizes or depressurizes the pressure-resistant solution chamber according to a preset or adjusted manner.
本发明提供的雾化模块性能稳定，相同条件下输出喷雾的重复性好，重复喷雾过程中输出水雾质量无显著变化。The performance of the atomization module provided by the invention is stable, the repeatability of the output spray is good under the same conditions, and the quality of the output water mist does not change significantly during the repeated spraying process.
本发明的第二方面提供了一种雾化器，包括上述技术方案所述的雾化模块1、贮药模块2、控制模块3、定量给液模块4和动力模块5，所述控制模块4分别与雾化模块1、定量给液模块4和动力模块5连接以控制雾化器雾化。本发明提供的雾化器结构是包括上述技术方案所述雾化模块的其中一种结构，其中的控制模块3、定量给液模块4和动力模块5等可全部或部分缺省。动力模块5为控制模块、定量给液模块3和雾化模块1中的热源13提供能量，热源13中也可以自行设置独立的动力源。控制模块3与定量给液模块4、雾化模块1和动力模块5连接，用于控制上述模块的开闭和运行，控制模块3可控制雾化模块1内的压力组件和加热组件，从而控制雾化模块的运行。The second aspect of the present invention provides an atomizer, including the
在本发明的一些具体实施方案中，所述定量给液模块4和雾化模块11中的压力组件14可以由一个定量液泵替代。所述定量给液模块4每次给液剂量优选为0.03-0.2mL，在一些具体实施方案中该定量给液剂量可以调节。In some specific embodiments of the present invention, the pressure components 14 in the
本发明优选的，所述雾化器还包括可感应吸气气流的气流传感器，当感应到吸气气流时自动启动雾化模块进行喷雾，实现自动感应式喷雾给药。Preferably in the present invention, the nebulizer further includes an airflow sensor capable of sensing the inhalation airflow, and when the inhalation airflow is sensed, the atomization module is automatically activated for spraying, so as to realize automatic inductive spray administration.
本发明的第三方面提供了一种雾化方法，利用前述技术方案所述雾化模块或上述技术方案所述雾化器实现，其步骤包括：The third aspect of the present invention provides an atomization method, which is realized by using the atomization module described in the aforementioned technical solution or the atomizer described in the aforementioned technical solution, and the steps include:
S1.待雾化液体进入耐压溶液腔后，对耐压溶液腔增压并加热，使雾化液体在耐压溶液腔内温度超过其标准大气压下的沸点10℃以上；S1. After the atomized liquid enters the pressure-resistant solution chamber, pressurize and heat the pressure-resistant solution chamber, so that the temperature of the atomized liquid in the pressure-resistant solution chamber exceeds its boiling point at standard atmospheric pressure by more than 10°C;
S2.继续对耐压溶液腔加压，直至耐压溶液腔内的待雾化液体压力高于密封喷嘴中盲孔的预设压力时，盲孔发生形变破裂，待雾化液体自形变的盲孔喷出并雾化。S2. Continue to pressurize the pressure-resistant solution chamber until the pressure of the liquid to be atomized in the pressure-resistant solution chamber is higher than the preset pressure of the blind hole in the sealing nozzle. The hole is sprayed out and atomized.
本发明所述的待雾化液体可以是水溶液或有机溶剂，可以是溶液或悬浊液，其中溶剂可以是水、生理盐水、乙醇等药物常用溶剂或这些溶剂的混合物。溶质为药物活性成分，例如β肾上腺能受体激动剂、糖皮质激素或抗胆碱能药物等常见吸入药物，上述溶液或悬浊液在本发明所述的雾化模块、雾化器及雾化方法均可适用。在本发明的一些具体实施方式中，为了避免加压、加热影响药物活性，步骤S1还包括在增压、加热前向待雾化液体添加溶剂、耐压保护剂和耐热保护剂中的一种或多种，例如甘油、丙二醇和表面活性剂等用于调节液体力学或热力学特性的物质。The liquid to be nebulized in the present invention can be an aqueous solution or an organic solvent, a solution or a suspension, wherein the solvent can be water, normal saline, ethanol or a mixture of these commonly used pharmaceutical solvents. The solute is the active ingredient of the drug, such as common inhaled drugs such as β-adrenergic receptor agonists, glucocorticoids, or anticholinergic drugs. chemical methods are applicable. In some specific embodiments of the present invention, in order to avoid pressurization and heating from affecting the drug activity, step S1 further includes adding one of a solvent, a pressure-resistant protective agent and a heat-resistant protective agent to the liquid to be atomized before pressurization and heating. One or more substances, such as glycerin, propylene glycol and surfactants, are used to adjust the fluid dynamics or thermodynamic properties.
下面结合实施例对本发明提供的技术方案进行详细的说明，但是不能把它们理解为对本发明保护范围的限定。下列实施例中未注明具体条件的实验方法，通常按照常规条件，或按照制造厂商所建议的条件。The technical solutions provided by the present invention will be described in detail below in conjunction with the examples, but they should not be interpreted as limiting the protection scope of the present invention. For the experimental methods without specific conditions indicated in the following examples, the conventional conditions or the conditions suggested by the manufacturer are usually followed.
实施例1Example 1
如图1-5所示，一种雾化器的雾化模块11包括耐压溶液腔11、密封喷嘴12、加热组件13、压力组件14和紧固件15；耐压溶液腔11为一个可装入液体的腔体，其上设置有一个出液口111和一个进液口112；密封喷嘴12包括过渡段121和喷雾片122，过渡段为内径0.4-0.6mm的硅胶管，喷雾片122上设置有盲孔1221，盲孔为向内密封状态，盲孔直径为0.05-0.15mm、盲孔厚度为0.008-0.015mm，盲孔、过渡段和耐压溶液腔的圆心在同一直线上；过渡段插入出液口111内；紧固件15设置在密封喷嘴外，并在过渡段121对应的区域设有开孔，开孔的直径为过渡段外径的85-95％；As shown in Figures 1-5, an
所述加热组件13包括2-50W的单头陶瓷热棒(热源131)、不锈钢304材质的热传递模块132和温度传感器133，加热组件的温度传感器为PT100热电偶，温控仪感应到热传递块超过设定温度时停止加热，将热传递块控制在预期温度区间内。一般设定过热温度为110℃-180℃，优选的过热温度为120℃-150℃。热传递模块132包覆在耐压溶液腔1外部，热源131固定于热传递模块的内部，热源的外表面与热传递模块内部紧密接触保证导热效率；The heating assembly 13 includes a 2-50W single-head ceramic heating rod (heat source 131), a
加压组件为液泵，可对耐压溶液腔11进行加压。耐压溶液腔11的进液口112可与能输入液体的结构连接，以便待雾化液体进入耐压溶液腔。The pressurizing component is a liquid pump, which can pressurize the pressure-
实施例2Example 2
如图6所示，一种雾化器包括实施例1所述的雾化模块1、贮药模块2、控制模块3、定量给液模块4和动力模块5。动力模块5为控制模块、定量给液模块3和雾化模块1中的热源13提供能量，热源13中也可以自行设置独立的动力源。控制模块3与定量给液模块4、雾化模块1和动力模块5连接，用于控制上述模块的开闭和运行，控制模块3可控制雾化模块1内的压力组件和加热组件，从而控制雾化模块的运行。As shown in FIG. 6 , an atomizer includes the
使用时，通过控制模块3启动定量给液模块4，定量给液模块4将额定的待雾化液体泵入耐压溶液腔11内，开启压力组件14和加热组件13，对耐压溶液腔11内的待雾化液体增压加热，使待雾化液体处于过热状态，当过度热超过10℃后，压力组件14继续增压直至内部压力超过盲孔1221的承压上限，待雾化液体冲破盲孔喷出，由于外部压力降低触发闪蒸并快速雾化，输出水雾粒径的中位数为2-5μm，适宜雾化给药。When in use, the quantitative
实施例3Example 3
采用实施例2所述的雾化器对生理盐水进行雾化，额定过热温度140℃，喷雾压力0.4MPa，单喷容量0.05mL，密封喷嘴过渡段直径0.4mm，盲孔开孔直径0.15mm条件下。The atomizer described in Example 2 is used to atomize physiological saline, the rated superheat temperature is 140°C, the spray pressure is 0.4MPa, the single spray volume is 0.05mL, the diameter of the transition section of the sealed nozzle is 0.4mm, and the opening diameter of the blind hole is 0.15mm. Down.
雾化结果如表1和图7-9所示，在标准大气大气压、环境温度22℃、相对湿度<45％条件输出水雾的中位空气动力学粒径为1.56μm，FPF(<5μm)比例约为89％。雾化性能显著优于现有的市售雾化器。The atomization results are shown in Table 1 and Figures 7-9. Under the conditions of standard atmospheric pressure, ambient temperature 22°C, and relative humidity <45%, the median aerodynamic particle size of the output water mist is 1.56 μm, and FPF (<5 μm) The ratio is about 89%. Atomization performance is significantly better than existing commercially available atomizers.
表1标准条件下生理盐水雾化性能Table 1 Atomization performance of physiological saline under standard conditions
由图9所示的不同雾化容量下雾化质量比较图看出，本发明提供的雾化模块工作范围广，所设定的每喷剂量变化时，输出喷雾质量特征稳定，中位粒径始终分布在2–5微米之间。It can be seen from the comparison chart of atomization quality under different atomization capacities shown in Fig. 9 that the atomization module provided by the present invention has a wide working range, and when the set spray volume changes, the output spray quality characteristics are stable, and the median particle diameter Consistently distributed between 2–5 microns.
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以作出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。The above is only a preferred embodiment of the present invention, it should be pointed out that for those of ordinary skill in the art, without departing from the principle of the present invention, some improvements and modifications can also be made, and these improvements and modifications should also be It is regarded as the protection scope of the present invention.
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