A nebulizer and nebulization system for treating lung diseases

Abstract

This application relates to an atomizing device and system, wherein the atomizing device includes: a pump chamber; an air pump located within the pump chamber, the air pump having an air inlet and an air outlet, the air inlet and the air outlet being respectively connected to the outside of the pump chamber via corresponding pipelines; a secondary shock absorption device including: a plurality of first buffer blocks disposed at the bottom of the pump chamber; a primary shock absorption platform supported by the first buffer blocks; and a plurality of second buffer blocks disposed on the primary shock absorption platform and supporting the air pump. This application improves the atomization effect and user experience through optimization of the atomizing device.

Description

Technical Field

[0001] This application relates to the field of nebulization technology, and in particular to a nebulization device and nebulization system for treating lung diseases. Background Technology

[0002] Nebulizers typically transform liquids into micron-sized liquid particles. In clinical endoscopic treatments, nebulized drug delivery is often necessary to ensure uniform distribution of the injected liquid medication, thereby improving the evenness of binding between the nebulized material and the relevant tissues. The fluid input to the nebulizer can include therapeutic or restorative liquids. Current nebulizers are used to administer medications by inhalation, breaking down the liquid into a mist of tiny particles or droplets, allowing for relatively efficient inhalation and absorption. However, during inhalation, it is difficult for all the medication to reach the lesion, resulting in unnecessary losses. Furthermore, before reaching the lesion, the medication itself may cause damage to organs along its route due to its side effects, posing potential safety risks.

[0003] Existing atomizers have poor atomization effects, their structure needs improvement, and their applicable scenarios are limited. Summary of the Invention

[0004] Based on this, it is necessary to address the aforementioned technical problems. This application discloses a nebulization device for treating lung diseases, comprising:

[0005] The pump chamber has a sound-absorbing baffle on its inner wall;

[0006] An air pump is located in the pump chamber. The air pump has an air inlet and an air outlet, and the air inlet and the air outlet are respectively connected to the outside of the pump chamber through corresponding pipelines.

[0007] A heat exchanger is located in the pump chamber and thermally coupled to the air pump, with at least a portion of the heat exchanger exposed to the chamber wall of the pump chamber;

[0008] A cooling fan is located outside the pump chamber and is thermally coupled to the heat exchanger.

[0009] Optionally, the atomizing device further includes a housing, with the pump chamber located at the bottom inside the housing, at least a portion of the housing serving as the wall of the pump chamber, or the wall of the pump chamber being independently configured;

[0010] The housing is equipped with an air passage connector, and the air pumps are multiple units connected in parallel, with the air outlets of each air pump connected to the air passage connector via a main pipe.

[0011] Optionally, a heat dissipation window is provided on the top wall of the pump chamber for the cooling airflow of the cooling fan to pass through, and at least a portion of the heat exchange component is aligned with the heat dissipation window.

[0012] Optionally, the heat exchangers are arranged in groups, and each group of heat exchangers has at least two pieces with an airflow slit between them. The airflow slit is aligned with the heat dissipation window and the cooling fan.

[0013] Optionally, the heat exchanger is a semiconductor cooling chip with its cold end thermally coupled to the pump head of the air pump, its hot end exposed to the heat dissipation window, and its cold end attached to the heat dissipation fins of the air pump body.

[0014] Optionally, the bottom wall of the pump chamber is provided with an air exchange port.

[0015] Optionally, the atomizing device further includes a pressure relief valve installed in the main pipe of the air pump, and the outlet of the pressure relief valve is connected to the pump chamber through a pressure relief duct;

[0016] The pressure relief valve is equipped with a pressure relief duct that connects to the pump chamber.

[0017] Optionally, the pressure relief duct creates a positive pressure environment in the pump chamber, and the cooling fan draws air out of the pump chamber to form a circulating air duct.

[0018] Optionally, the atomizing device further includes a housing, with the pump chamber located at the bottom inside the housing, at least a portion of the housing serving as the wall of the pump chamber, or the wall of the pump chamber being independently configured;

[0019] The housing is equipped with an air passage connector, and the air pumps are multiple units connected in parallel, with the air outlets of each air pump connected to the air passage connector via a main pipe.

[0020] This application also discloses an atomization system, based on the atomization device in the above technical solution, wherein the atomization device further includes...

[0021] A syringe, comprising a barrel mounted within a housing and a piston slidably mounted within the barrel, the barrel having an outlet and communicating with a fluid connection.

[0022] The drive mechanism is linked to the piston of the syringe;

[0023] A nebulizing conduit includes a tube body, one end of which is a proximal end and the other end is a distal end that can extend into the bronchus. The proximal end is connected to the gas path connector and the liquid path structure. The tube body has a channel inside that can deliver fluid from the proximal end to the distal end. An nebulizing head is provided at the distal end of the tube body. A microfluidic chip is disposed inside the nebulizing head. The fluid in the channel is atomized and output after being atomized by the microfluidic chip.

[0024] Optionally, the atomizing device includes

[0025] The pump chamber has a sound-absorbing baffle on its inner wall;

[0026] The air pump;

[0027] The secondary damping device includes:

[0028] Several first buffer blocks are disposed inside the housing;

[0029] The primary shock absorption platform is supported by each first buffer block;

[0030] Several second buffer blocks are set on the primary shock absorption platform and support the air pump.

[0031] The specific beneficial effects of this application will be explained in detail below with reference to the specific structure, and will not be repeated here. Attached Figure Description

[0032] Figure 1a This is a schematic diagram of the structure of the atomizing conduit in one embodiment of this application;

[0033] Figure 1b This is an exploded view of the distal end of the atomizing conduit body in one embodiment of this application;

[0034] Figure 1c This is an exploded view of the atomizing head in one embodiment of this application;

[0035] Figure 1d for Figure 1c A diagram from another angle;

[0036] Figure 1e This is a cross-sectional view of the atomizing head in one embodiment of this application;

[0037] Figure 1f This is an exploded view of a microchannel chip in one embodiment of this application;

[0038] Figure 2a This is a schematic diagram of the structure of a microchannel chip in one embodiment of this application;

[0039] Figure 2b This is a schematic diagram of the internal structure of a microchannel chip in one embodiment of this application;

[0040] Figure 2c for Figure 2b Cross-sectional view along line AA;

[0041] Figure 3a This is a schematic diagram of the internal structure of a microchannel chip in one embodiment of this application;

[0042] Figure 3b This is a schematic diagram of the internal structure of a microchannel chip in one embodiment of this application;

[0043] Figure 3c for Figure 3b Cross-sectional view of line BB;

[0044] Figure 3dfor Figure 3b Enlarged view of section A1;

[0045] Figure 4a This is a schematic diagram of the internal structure of a microchannel chip in one embodiment of this application;

[0046] Figure 4b for Figure 4a Cross-sectional view of DD along the line;

[0047] Figure 5a This is a schematic diagram of the internal structure of a microchannel chip in one embodiment of this application;

[0048] Figure 5b This is a schematic diagram of the internal structure of a microchannel chip in one embodiment of this application;

[0049] Figure 5c This is an enlarged view of the flow channel portion of a microchannel chip in one embodiment of this application;

[0050] Figure 6a This is a schematic diagram of the internal structure of a microchannel chip in one embodiment of this application;

[0051] Figure 6b for Figure 6a Cross-sectional view of EE along the line;

[0052] Figure 7a This is a schematic diagram of the internal structure of a microchannel chip in one embodiment of this application;

[0053] Figure 8a This is a structural block diagram of an atomized drug delivery system according to an embodiment of this application;

[0054] Figure 8b This is a structural block diagram of an atomized drug delivery system according to an embodiment of this application;

[0055] Figure 8c This is a structural block diagram of an atomized drug delivery system according to an embodiment of this application;

[0056] Figure 8d This is a circuit diagram of a switching circuit in one embodiment of this application;

[0057] Figure 8e This is a circuit diagram of an air pump speed control circuit in one embodiment of this application;

[0058] Figure 8f This is a schematic diagram illustrating the working principle of the control unit in one embodiment of this application;

[0059] Figure 9 This is a schematic flowchart of a control method for a nebulized drug delivery system in one embodiment of this application;

[0060] Figure 10This is a schematic diagram of an atomizing device in one embodiment of this application;

[0061] Figure 11 for Figure 10 A side view of the atomizing device in the diagram;

[0062] Figure 12 for Figure 10 A isometric view of the back of the atomizing device in the diagram;

[0063] Figure 13 for Figure 10 A schematic diagram of the back of the atomizing device;

[0064] Figure 14 This is a schematic diagram of the gas phase pipeline assembly in an atomizing device according to one embodiment of this application;

[0065] Figure 15 This is a schematic diagram of the gas phase pipeline connection in one embodiment of this application;

[0066] Figure 16 for Figure 15 A schematic diagram of the gas phase pipeline from another perspective;

[0067] Figure 17 This is a schematic diagram of the air pump installation in one embodiment of this application;

[0068] Figure 18 for Figure 17 A schematic diagram of the air pump from another perspective;

[0069] Figure 19 for Figure 17 Another perspective diagram of the air pump in the middle;

[0070] Figure 19a This is a schematic diagram of a two-stage vibration reduction system in one embodiment;

[0071] Figure 20 This is a schematic diagram of the assembly relationship between the air pump and the cooling assembly in one embodiment of this application;

[0072] Figure 21 for Figure 20 Another perspective view of the air pump and cooling components in the middle;

[0073] Figure 22 for Figure 20 A schematic diagram showing the connection between the air pump, cooling components, and pump chamber.

[0074] Figure 23 This is a schematic diagram of the internal assembly of the atomizing device on the front side in one embodiment of this application;

[0075] Figure 24 This is a front view of an atomizing device in one embodiment of this application;

[0076] The annotations in the figure are explained as follows:

[0077] 900, Tube body; 901, Proximal end; 902, Distal end; 910, Atomizing head; 905, T-joint; 906, Interface; 907, First interface; 908, Second interface; 909, Stress dispersion head;

[0078] 920. Microfluidic chip; 921. First unit chip; 922. Second unit chip; 930. Identifier;

[0079] 940. Sheath; 950. First inner tube; 951. First connecting pipe; 960. Second inner tube; 961. Second connecting pipe; 970. Connecting sleeve; 971. Flow chamber; 972. Connector; 973. Distal portion; 974. Proximal portion;

[0080] 100, Reference plane; 110, Inlet; 111, First fluid inlet; 112, Second fluid inlet; 120, Outlet;

[0081] 130. Main flow channel; 135. Divergence zone; 140. Side flow channel;

[0082] 210. Extension section; 240. Narrowing section; 220. Expansion section; 231. Enlargement section; 232. Holding section; 233. Interface section; 230. Exit section;

[0083] 300. Branch flow channel;

[0084] 310. First branch channel; 311. First sub-channel; 312. Second sub-channel;

[0085] 320. Second branch flow channel; 321. First section; 322. Second section;

[0086] 400. Distribution component; 401. First side; 402. Second side; 403. Chamfer; 405. Protruding pillar; 450. Separator;

[0087] 500. Housing; 5001. Third buffer block; 501. Air connection; 5011. Second filter; 502. Liquid connection; 503. Exhaust port;

[0088] 510. Pump room; 511. Main pipe; 512. Pressure relief valve; 5121. Output pipeline; 5122. Pressure relief duct; 5123. Four-way connector; 513. Soundproof partition; 514. Secondary vibration damping device; 5141. First buffer block; 5142. Primary vibration damping platform; 5143. Second buffer block; 5144. First mounting slot; 5145. Second mounting slot;

[0089] 520. Air pump; 521. Air inlet pipe; 5211. First filter; 522. Pressure transmitter; 523. Gas cylinder; 524. Solenoid valve; 525. Pressure regulating valve;

[0090] 530. Cooling components; 531. Cooling fan; 532. Heat dissipation window; 533. Heat exchanger; 534. Airflow slit;

[0091] 600. Syringe; 610. Bottle body; 620. Piston; 630. Adapter; 631. Limiting part; 632. Adaptive identification tag;

[0092] 700. Drive mechanism; 701. Fixed base; 702. Motor; 703. Slide;

[0093] 800, Operation screen. Detailed Implementation

[0094] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0095] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0096] In this application, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number or order of the indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0097] In this application, the terms “comprising” and “having”, and any variations thereof, are intended to cover non-exclusive inclusion, for example, a system, product, or device that includes a series of units is not necessarily limited to those units that are explicitly listed, but may include other units that are not explicitly listed or that are inherent to such products or devices.

[0098] See Figure 1a and Figure 1bIn one embodiment of this application, an atomizing conduit is provided, including a tube body 900. One end of the tube body 900 is a proximal end 901, and the other end is a distal end 902 that can extend into the bronchus. The tube body 900 has a channel for conveying fluid from the proximal end 901 to the distal end 902. An atomizing head 910 is provided at the distal end 902 of the tube body 900. That is, in terms of the atomizing conduit as a whole, the distal end 902 serves as the atomizing head 910. A microfluidic chip 920 is disposed inside the atomizing head 910. The fluid in the channel is atomized and output after being atomized by the microfluidic chip 920. A distribution structure capable of acting on at least a portion of the fluid is provided inside the microfluidic chip 920.

[0099] In this embodiment, the nebulizing cannula can extend into the bronchi to reach the lesion site. Depending on the treatment objective, the fluid may contain pre-dispersed therapeutic substances, such as drugs, chemical agents, solutions containing biological cells or tissues, or solutions containing cellular secretions. The treatment objective may be, for example, the repair of lung injuries caused by pneumonia or asthma.

[0100] Depending on the properties of the therapeutic substance, the fluid itself can be a liquid phase, a gas phase, or a more complex mixture. Nebulization aims to further disperse the fluid into smaller particles to promote absorption and uniform drug delivery. Each fluid delivery channel extends from the proximal end 901 of the tube body 900 to the distal end 902 and converges at the nebulizer head 910. That is, each channel is independent until it reaches the nebulizer head 910, which is especially beneficial for fluids of different phases, preventing premature mixing and weakening of the nebulization effect. In various embodiments of this application, the distal end or distal side refers to the end or side relatively closer to the nebulizer head outlet, and the proximal end or proximal side refers to the end or side relatively farther from the nebulizer head outlet along the direction of the nebulizer tube. At various points in the nebulizer tube, upstream and downstream are defined according to the direction of fluid flow.

[0101] The tube body 900 can be made of metal or synthetic material to provide the necessary mechanical properties and safety of intervention. Depending on the needs of the fluid being transported, it can be in the form of a single tube or multiple tubes. When multiple tubes are used, at least two tubes can be arranged side by side or nested inside and outside. Each tube can be configured independently or can be an integrated multi-cavity tube.

[0102] See Figures 1a to 1f In one embodiment, the tube body 900 includes a sheath 940, a first inner tube 950, and a second inner tube 960. The microfluidic chip 920 includes a first fluid inlet 111, a second fluid inlet 112, and an outlet 120, through which fluid is atomized within the microfluidic chip. Both the first inner tube 950 and the second inner tube 960 extend within the sheath 940, with the distal end of the first inner tube 950 connected to the first fluid inlet 111. The sheath 940 provides protection and necessary mechanical support for each inner tube. Figure 1b The dashed line in the figure indicates the assembly position of the sheath 940.

[0103] Using the extension direction of the tube body 900 as a reference, the orientation of the outlet 120 of the microfluidic chip 920 can be axial and distal. To facilitate passage through narrower bronchi, the outer diameter of the sheath 940 is generally no greater than 1.2mm to 2.0mm; for example, the outer diameter of the nebulizer catheter is 1.8mm, enabling precise nebulized drug delivery to reach areas inaccessible by endoscopy. Since the nebulizer catheter of this application can extend into the bronchi, its length is correspondingly matched; for example, the length of the sheath 940 is 800mm to 1200mm.

[0104] The nebulizing catheter also includes a tee fitting 905, the proximal end of which connects to one of the interfaces of the tee fitting 905, such as... Figure 2b The interface 906 shown in the figure. The proximal ends of the first inner tube 950 and the second inner tube 960 extend out of the sheath tube 940 and are respectively connected to the other two interfaces of the tee member 905 inside the tee member 905, so as to realize the connection of the fluid input to the first inner tube and the second inner tube.

[0105] A stress-dispersing head 909 can also be provided at interface 906 to alleviate stress and reduce breakage of the sheath 940. The other two interfaces can be, for example, a first interface 907 and a second interface 908. Both can be Luer connectors. The first interface 907 and the second interface 908 can be connected to an external filling device for supplying fluid to the inner tubes.

[0106] See Figures 1b-1e The atomizing head 910 includes a microchannel chip 920 and a connecting sleeve 970 fixed to the distal end of a sheath 940. The connecting sleeve 970 is located around the microchannel chip 920, and its two ends are sealed relative to the outer periphery of the microchannel chip 920. The inner wall of the connecting sleeve 970 and the outer periphery of the microchannel chip 920 form a flow guide chamber 971. The second fluid inlet 112 and the distal end of the second inner tube 960 are both connected to the flow guide chamber 971. The flow guide chamber 971 can be understood as an annular space formed around the microchannel chip 920. Fluid is transported into the microchannel chip 920 through this annular space via the second fluid inlet 112. The sheath provides the necessary structural stability for the first and second inner tubes. The first inner tube is connected to the first fluid inlet, allowing the first fluid to flow into the microchannel chip. The flow guide chamber surrounds the microchannel chip, and multiple second fluid inlets can be provided around the contact points.

[0107] A connector 972 is fixedly attached to the proximal end of the microfluidic chip 920. The proximal end of the connecting sleeve 970 is sealed and wrapped around the outer periphery of the connector 972. A first pair of connecting tubes 951 is inserted into the connector 972. The distal end of the first pair of connecting tubes 951 is connected to the first fluid inlet 111. The proximal end of the first pair of connecting tubes 951 is sealed and fitted onto the distal end of the first inner tube 950. A second pair of connecting tubes 961 is inserted into the proximal side of the connecting sleeve 970. The distal end of the second pair of connecting tubes 961 passes through the connecting sleeve 970 and connects to the flow guide chamber 971. The proximal end of the second pair of connecting tubes 961 is sealed and fitted onto the distal end of the second inner tube 960.

[0108] The microfluidic chip 920 protrudes distally from the connecting sleeve 970, with the axial dimension of the protrusion being 20%–30% of its own axial length. The first inner tube 950 and the second inner tube 960 can be made of, for example, plastic, while the first connecting tube 951 and the second connecting tube 961 can be made of, for example, metal, to ensure the flexibility and stability of the tube body and prevent bending at the connection. The connector 972 abuts against the microfluidic chip 920, with its proximal end sealed and wrapped by the connecting sleeve 970, forming a restraining and limiting action on the microfluidic chip 920 in the axial direction of the tube body. Along the axial direction of the sheath 940, the connecting sleeve 970 has a split structure, including a distal portion 973 and a proximal portion 974 that are sealed and fixed. The flow guide chamber 971 is located between the distal portion and the outer periphery of the microfluidic chip. The overall size of the connecting sleeve is relatively small, and the split structure facilitates the processing of the flow guide chamber. Nebulizers can be driven by a gas source, such as air, a mixture of hydrogen, oxygen, and carbon dioxide in different proportions, or other gases that promote lung recovery.

[0109] See Figure 1e , Figures 2a-2c In one embodiment, the microfluidic chip 920 includes a first unit chip 921 and a second unit chip 922 stacked and fixed. At least one of the two unit chips has a microfluidic channel etched on its opposite side to guide fluid through. The two unit chips are processed separately, which facilitates the adjustment and change of the depth and morphology of the microfluidic channel.

[0110] Using the stacked surface of the two unit wafers as reference surface 100, which is the side of the etched unit wafer facing the other unit wafer, the depth of the microchannel in the direction perpendicular to reference surface 100 is 30~300 micrometers, more preferably 75±25 micrometers. The stacked surface of the two unit wafers is the contact surface between the first unit wafer 921 and the second unit wafer 922, and the depth of the microchannel is preferably the same everywhere, for example, it can be 50 micrometers. Referring to the cross-sectional views of the following embodiments, the etching depth is represented by the width of the blank band on the right side of each cross-sectional view. The depth of the chip channel affects the channel area, which in turn affects the flow rate and fluid pressure. An appropriate range of values ​​ensures that larger molecules or cells in the solution can pass through and maintains the fluid pressure. When the microchannel space is large, it allows the transport of larger particles, such as human stem cells, small molecule peptides, or even protein cells, generally in the range of 20~60 micrometers, for example, 50 micrometers.

[0111] The microfluidic chip 920 can be a cuboid in shape, composed of a first unit wafer 921 and a second unit wafer 922 with approximately the same three-dimensional dimensions. One of the first unit wafer 921 and the second unit wafer 922 can be made of silicon, and the other of glass. Microchannels are etched on the side of the silicon unit wafer facing the other unit wafer. After etching, the two are stacked, fixed, and bonded into a single structure to obtain the microfluidic chip 920. During the etching process, etching is also performed in areas outside the product cutting lines to ensure the unobstructed flow of the channels in the microfluidic chip.

[0112] In this embodiment, the direction in which the reference surface 100 extends along the tube body 900 is defined as the length direction L of the microfluidic chip 920, and the length of the microfluidic chip 920 can be, for example, 2500 micrometers. The direction perpendicular to the extension of the tube body 900 is defined as the width direction W of the microfluidic chip 920, and the width can be, for example, 900 micrometers. In the direction H perpendicular to the reference surface 100, the size of the microfluidic chip 920 can be, for example, 600 micrometers. Of course, the microfluidic chip 920 can be further adjusted according to the size of the tube body 900 and the requirements for atomization and mixing effects.

[0113] The atomizing head 910 has an inlet connected to the channel and an outlet for outputting the atomized fluid. The outlet is located on the distal side of the microchannel chip 920, and one or more inlets can be provided. When there is only one inlet, it can be configured on the proximal side of the microchannel chip 920.

[0114] In the case of multiple inlets, at least one inlet is located on the proximal side of the microchannel chip 920, and at least one inlet is located on the side of the microchannel chip 920 along the radial direction of the tube body 900; the inlet 110 on the side and the inlet on the proximal side are configured with independent flow channels within the tube body 900.

[0115] Taking multiple inlets as an example, inlet 110 includes at least a first fluid inlet 111 and a second fluid inlet 112, each fluid inlet having an independently configured flow channel within the tube body 900. The first fluid inlet 111 and the second fluid inlet 112 refer to inlets that allow flow of two different fluid types, and the specific number of inlets is not limited. Specifically, the first fluid inlet 111 is located on the proximal side of the microchannel chip 920; along the radial direction of the tube body 900, the second fluid inlet 112 is located beside the microchannel chip 920. Further, there are two second fluid inlets 112, distributed on two opposite sides of the microchannel chip 920. Specifically, these are two opposite sides in the width direction of the reference surface 100. The microchannel chip 920, as a form of realizing the atomizing function of the atomizing head 910, has inlets 110 including the first fluid inlet 111 and the second fluid inlet 112; outlet 120 is the outlet of the atomizing head 910, and the interior of the microchannel chip 920 is a chip flow channel connecting inlets 110 and outlet 120.

[0116] like Figure 2b As shown, from a perspective along the vertical reference plane 100, at least one channel in the chip channel has a width greater than or equal to 50 micrometers. Setting a threshold width for the chip channel ensures that molecules or cells with a diameter greater than or equal to 50 micrometers in the solution can pass through, reducing the possibility of damage during passage. That is, there is at least one path from any inlet to the outlet, and the width of this path is not less than the aforementioned dimension at any point, allowing larger-diameter therapeutic materials to pass through without blockage or breakage.

[0117] Preferably, at least one channel in the chip channel has a width of 100±10 micrometers; the outlet 120 has a width of 100±10 micrometers. This allows molecules or cells in the solution to pass through the chip channel in parallel during atomization, reducing cell damage.

[0118] In the various examples of this application, A±B represents values ​​ranging from (AB) to (A+B), where A is greater than B and both are numerical values. For example, an inlet width of 300±100 micrometers indicates that the inlet width is between 200 and 400 micrometers.

[0119] In one embodiment, the chip flow channel includes a main flow channel 130 and a side flow channel 140. The main flow channel 130 is connected at one end to a first fluid inlet 111 located on the proximal side and at the other end to an outlet 120. The side flow channel 140 is connected at one end to a second fluid inlet 112 located on the side and at the other end to the main flow channel 130. The first fluid inlet 111 is used to deliver a first fluid, and the second fluid inlet 112 is used to deliver a second fluid. For example, the first fluid may be a liquid phase and the second fluid may be a gas phase, or vice versa. The width of the second fluid inlet 112 may be, for example, 200 micrometers, and its distance from the proximal end of the microfluidic chip 920 along the longitudinal direction L is 1300 ± 30 micrometers. The main flow channel 130 can be understood as a flow channel located in the middle region of the microfluidic chip 920.

[0120] The distribution structure can be at least one of the following: In one embodiment, the distribution structure consists of multiple branch channels 300 located at the end of the side channel 140, through which the side channel 140 intersects with the main channel 130, and the width of the branch channels 300 is 20±10 micrometers. In another embodiment, the distribution structure consists of multiple spaced distribution elements 400. Further, the distribution elements 400 are arranged in an array with a gap of 10±5 micrometers and a size of 40±20 micrometers. Changing the size of different branch channels can adjust the fluid pressure of different branch channels, and the arrayed distribution elements can further disperse and release the fluid pressure. The gaps and sizes mentioned above refer to the dimensions on the reference surface. The size itself can be understood as a rectangle with a side length of 40±20 micrometers or a circle within that diameter range; other shapes can be approximated. The distribution element can be a protrusion 405 formed by the residue after etching the first unit plate 921 or the second unit plate 922.

[0121] Specifically, the distribution structure is located at the intersection of the main flow channel 130 and the side flow channel 140. Fluid mixing through multiple inlets and channels further enhances the atomization effect. The intersection point belongs to either the main flow channel 130 or the side flow channel 140, but is close to the other. For example, the intersection point may be located in the main flow channel 130 near the side flow channel 140, or the division may not be strict and does not affect the atomization effect. In one implementation, the flow channel where the distribution structure is located is in the gas phase, and the distribution structure can disperse the gas phase fluid. When the liquid phase fluid uses a solution containing biological cells, the cell damage rate is reduced.

[0122] In one embodiment, a portion of the main channel 130 is a widened expansion section, and at least a portion of the side channels 140 converges to the expansion section at multiple, spaced-apart points. Widening the main channel alters the fluid state, and the multiple convergence points optimize the mixing of the two fluids and the final atomization effect. Compared to a single convergence or directly dispersing one phase to another, the droplet size after atomization in this application can be further reduced, improving the distribution of therapeutic substances and saving dosage. The widening of the expansion section can be 1.45 to 2 times its original size, with a gradual widening followed by gradual narrowing. It can either narrow directly to the outlet or narrow and then extend to the outlet at a constant width. The side channels 140 as a whole can either converge entirely to the expansion section or partially to the expansion section, with another portion converging in other parts of the main channel, preferably downstream of the expansion section.

[0123] Furthermore, two of the confluence locations are arranged sequentially along the extension direction of the main channel 130, or two of them are distributed on both sides of the main channel 130. The confluence location of the side channel 140 and the main channel 130 is called the confluence port, and at least one confluence port is oriented perpendicular to or inclined to the extension direction of the main channel 130, with an angle of 30 to 60 degrees, and inclined towards the outlet direction of the atomizing head.

[0124] The orientation of the junctions can affect the atomization effect and fluid resistance. If all junctions are parallel to the direction of the main channel, it is not conducive to the full mixing of the two phases. When multiple junctions are arranged along the direction of the main channel, the orientation of each junction can be slightly different. That is, the orientation of multiple junctions arranged sequentially along the direction of the main channel is not exactly the same. In some cases, all junctions can be set perpendicular to or inclined to the direction of the main channel.

[0125] See Figures 3a to 3d In one embodiment, the main channel 130 includes an extension section 210, an expansion section 220, and an outlet section 230 connected in sequence. The distinction between the three sections can be found in [reference needed]. Figure 3a The dotted lines indicate the location of the extension section 210, which is located near the microchannel chip and has a width of 250±50 micrometers. The expansion section 220 is wider than the extension section 210, with a maximum width of 1.45 to 2 times that of the extension section 210, for example, 375±75 micrometers. The outlet section 230 is connected to the outlet 120 and has a width of 100±50 micrometers. The variable diameter of the main channel facilitates the release of fluid pressure. Based on the variable diameter of the extension section, expansion section, and outlet section of the main channel, a narrowing section is added between the extension section and the expansion section to further reduce the difficulty of gas-liquid mixing in the expansion section.

[0126] The distinction between sections of the main channel 130 is determined based on the trend of width change. Along the direction from the near end to the far end, the initial increase in width of the main channel 130 is considered the entry into the expansion section 220; the section adjacent to the outlet where the width does not change is considered the outlet section 230. In the prior art, the formula for calculating flow resistance is: R = ΔP / Q. When the flow rate in the main channel remains constant per unit time, as the pressure difference between the extension section and the expansion section increases, the flow resistance in the expansion section decreases, thereby reducing the difficulty of gas-liquid mixing in the expansion section.

[0127] In this embodiment, the side channel 140 converges to the expansion section 220, and the maximum width of the side channel 140 is 200±50 micrometers. Furthermore, the width of the side channel 140 decreases continuously from upstream to downstream.

[0128] In this embodiment, the expansion segment 220 is specifically divided into three parts, which are, from the proximal end to the distal end, the expansion segment 231, the holding segment 232, and the interface segment 233. The distinction between the three segments is as follows: Figure 3b The dashed lines shown indicate that the width of the expanding section 231 continuously increases relative to the extension section 210; the maintaining section 232 keeps the width of the expanding section 220 unchanged, which can be understood as a change of less than 10% relative to the maximum width. The interface section 233 continuously shrinks relative to the expanding section 220 until it connects with the outlet section 230. The junction is the position where the maintaining section 232 connects with the side channel 140, specifically... Figure 3b The dashed lines on both opposite sides of the width direction of the middle section 232.

[0129] The distribution structure in this embodiment employs a distributor 400. The distributor 400 is located within the side flow channel 140 and adjacent to the junction of the side flow channel 140 and the main flow channel 130. The distributor 400 is positioned within a divergence zone 135 for dispersing the fluid. Correspondingly, the divergence zone 135 is located outside the two opposite sides of the expansion section 220.

[0130] Furthermore, the cross-section of each distribution component on the reference plane is a square, the square including a first side 401 and a second side 402 that are perpendicular to each other. The gap between the distribution components 400 is 10 micrometers, and they are arranged in a 3×8 strip array on each of the two opposite sides, the strip array extending generally along the length direction L.

[0131] The side channel 140 has an extending trend line that controls the direction of the fluid at a position adjacent to the divergence zone 135. Figure 3d (The dotted line in the diagram), the far end of the extended trend line is perpendicular to the second side 402. Further, a chamfer 403 is provided on one side of the distribution member 400 adjacent to the expansion section 220. The extended trend line is arc-shaped, and the width of the side channel 140 gradually narrows along the direction of the extended trend line.

[0132] The far end of the trend line can point directly towards the far end of the microchannel chip (e.g., Figure 5a ), or outward flipping relative to the central axis of the microfluidic chip (e.g. Figure 3b ), or converge inwards relative to the central axis of the microfluidic chip (such as Figure 6a ).

[0133] Figure 3a The interior of the expansion section 220 is a fully connected structure. Figure 4a In another embodiment, the expansion section 220 has an internal separator 450. The separator 450 divides the interior of the expansion section 220 into multiple parallel flow channels, each with a width of not less than 90 micrometers.

[0134] The shape of the spacer 450 can be, for example, a symmetrical hexagon, with the interior angles at the near and far ends being equal and acute. The spacer 450 can also be spindle-shaped, with the two opposite sides of the spindle-shaped spacer divided into two parallel flow channels in the width direction. The width of the flow channel can be, for example, 0.5 ± 0.2 times the width of the extension 210. In this embodiment, the width of the extension 210 remains unchanged and is 200 micrometers.

[0135] Along the length of the reference surface, the length of the isolator 450 is less than that of the expansion section 220. The distance from the distal end of the isolator 450 to the outlet section 230 is m1, and the distance from the proximal end of the isolator 450 to the extension section 210 is m2. Wherein, m1 is 100±10 micrometers, and m2 is 100±10 micrometers.

[0136] See Figures 5a-5b In one embodiment, the main flow channel 130 includes an extension section 210, a narrowing section 240, an expansion section 220, and an outlet section 230 connected sequentially. The extension section 210 is located near the proximal end of the microfluidic chip 920 and connects to the first fluid inlet 111, with a width of 250±50 micrometers. The narrowing section 240 connects the extension section 210 and the expansion section 220, with a narrower width relative to the extension section 210, and a minimum width of 100±50 micrometers. The expansion section 220 has a wider width relative to the extension section 210, with a maximum width of 375±75 micrometers. The outlet section 230 is connected to the outlet 120 and has a width of 100±50 micrometers. Based on the variable diameter of the extension section, expansion section, and outlet section of the main flow channel, the addition of a narrowing section between the extension section and the expansion section further reduces the difficulty of gas-liquid mixing within the expansion section.

[0137] The width variation trends and definition principles of extension section 210, expansion section 220, and outlet section 230 can be found in [reference needed]. Figure 3a The illustrated embodiments can also be found in [the following text is incomplete and likely refers to a different context]. Figure 5a The dashed line in the middle. Compared to Figure 3aIn the embodiment shown, a narrowing section 240 is provided, which continuously narrows in the direction from the proximal end to the distal end until it docks with the expansion section 220.

[0138] The region enclosed by the expansion segment 220 is hexagonal, with three pairs of parallel edges. For example... Figure 5b As shown in the dashed box, the hexagon has chamfered corners, and each interior angle is in the range of 110 to 130 degrees. For example, the area enclosed by the expansion segment 220 is a regular hexagon with chamfered corners, and each interior angle is 120 degrees.

[0139] In this embodiment, the distribution structure is implemented through branch channels 300. Side channels 140 converge to expansion section 220 and / or outlet section 230, with a width of 200±50 micrometers. Due to the different dimensions of the expansion section and outlet section, the atomization effect varies at different points where the side channels converge with the main channel. Converging at both points results in a better atomization effect. For the same side channel, there are at least two branch channels 300 connecting it. Specifically: at least one connects to the expansion section 220 of the main channel 130; and at least one connects to the outlet section 230 of the main channel 130.

[0140] The side channel 140 includes a first branch channel 310 that converges to the expansion section 220. The first branch channel 310 connects to the expansion section 220 at the proximal end of the expansion section 220, and the first branch channel 310 is symmetrically arranged on both sides in the figure. In this embodiment, the expansion section 220 includes three parts, namely, an expanding section whose width increases from the proximal end to the distal end, a maintaining section whose width remains the same, and an interface section whose width narrows. The first branch channel 310 connects to the expansion section 220 at the expanding section of the expansion section 220.

[0141] See Figure 5b and Figure 5c The side channel 140 includes a second branch channel 320 that converges to the outlet section 230. The second branch channel 320 is symmetrically arranged on both sides in the figure. The connection point between the second branch channel 320 and the outlet section 230 is adjacent to the expansion section 220. The second branch channel 320 can be divided into a first section 321 and a second section 322 that are connected from the proximal end to the distal end. The first section 321 extends along the length direction of the reference plane, and the second section 322 converges from the distal end of the first section 321 toward the outlet section 230 and directly connects with the proximal end of the outlet section 230. Further, the width of the first section 321 is greater than the width of the second section 322, and less than or equal to half the width of the second section 322. The width of the first section 321 is less than the width of the second fluid inlet, for example, it can be 50 micrometers. The distance between the two opposite edges of the first section 321 in the width direction W is D1, and D1 can be, for example, 600 micrometers. The width of the second section 322 gradually narrows from the proximal end to the distal end or the width remains unchanged. For example, it can adopt a... Figure 5c The dashed line shown serves as the boundary of the second segment 322, and the width of the second segment 322 remains unchanged.

[0142] Specifically, the side channel 140 is divided into a first branch channel 310 and a second branch channel 320 along its extension path from the proximal end to the distal end. Both branch channels are symmetrically arranged in the width direction W. The first branch channel 310 is further divided into a first sub-channel 311 and a second sub-channel 312 along its extension path from the proximal end to the distal end. The distal ends of both the first sub-channel 311 and the second sub-channel 312 are connected to the enlarged section of the expansion section 220. The distal end of the first sub-channel 311 is relatively upstream of the distal end of the second sub-channel 312. The width of the first sub-channel 311 is D2, and the width of the second sub-channel 312 is D3. Width D2 is twice or equal to width D3. For example, D2 can be 20 micrometers, and D3 can be 20 micrometers or 10 micrometers accordingly.

[0143] As shown in the diagram, the second sub-channel 312 extends in the same direction as the main channel, while the first sub-channel 311 extends at an angle to the main channel, for example, an angle of 30 to 60 degrees. (Above) Figures 2a to 5b In the process, the first fluid inlet is connected to the liquid phase fluid, and the second fluid inlet is connected to the gas phase fluid.

[0144] See Figure 6a and Figure 6b In a preferred embodiment, the main channel 130 includes an extension section 210, an expansion section 220, and an outlet section 230 connected in sequence. The width variation trends and defining principles of the extension section 210, expansion section 220, and outlet section 230 can be found in [reference needed]. Figure 3a The illustrated embodiments can also be found in [the following text is incomplete and likely refers to a different context]. Figure 6a The dashed line in the middle.

[0145] The first fluid inlet on the proximal side is connected to the gas phase fluid, and the two second fluid inlets on the side are connected to the liquid phase fluid.

[0146] The distribution structure is achieved through the distribution component 400. Compared to Figure 3a In this embodiment, the distribution component 400 is located within the expansion section 220 and adjacent to the outlet 120 of the extension section 210. The distribution components 400 are centrally arranged on the proximal side of the expansion section 220, and the overall length of the centrally arranged distribution components 400 is less than that of the expansion section 220 in the length direction of the reference plane.

[0147] The distribution member 400 is arranged in multiple rows at equal intervals from the proximal end to the distal end, for example, four rows, with a spacing of, for example, 10 micrometers. Each row includes protruding pillars 405 with equal spacing and a square cross-section on the reference surface, and the spacing between the protruding pillars 405 within each row is, for example, 10 micrometers. The protruding pillars 405 in each row are staggered, so the spacing between the protruding pillars in each row is not continuous along the length direction of the reference surface.

[0148] The two second fluid inlets are located near the junction of the extension section 210 and the expansion section 220. The side flow channel 140 starts from the second fluid inlet, turns in an arc, and points roughly to the far end. It then gradually approaches the expansion section 220 along a straight path until it merges and connects with the expansion section 220.

[0149] It is understandable that when the main channel 130 is used to pass gaseous fluid, the centrally arranged distribution component 400 can better change the airflow direction and interact with the liquid fluid entering and exiting from the side. Due to the pre-dispersion of the gas phase, damage to biological cells as therapeutic substances can also be reduced, and cell survival rate can be improved.

[0150] The nebulizer heads provided in the various embodiments of this application can balance nebulization effect and cell survival rate. Taking lung lesions as an example, during nebulization, the nebulized material (generally an aerosol) is evenly attached to the lesion area, avoiding aggregation and droplet formation. This saves on drug dosage, shortens treatment time, and reduces the side effects of the nebulized material on the human body. Furthermore, the good nebulization effect allows the nebulized material to drift a certain distance in the air, solving the problem of the nebulized material not being able to reach the lung lesions.

[0151] Figure 6a The embodiment shown corresponds to the 3D graphic. Figure 1e In adopting such Figure 6a When using the nebulizer chip shown, nebulization was performed on biological cells with a particle size of 50 micrometers. Under experimental conditions of a liquid flow rate of 1 mL / min and a gaseous fluid pressure of 0.15 MPa, the experimental data for staining to test cell mortality were even better, with cell viability exceeding 90%. See [link to relevant documentation]. Figure 4a and Figure 7a In various embodiments of this application, the microchannel chip may be provided with an identifier 930. The identifier is located on the side of the etched unit sheet facing another unit sheet to facilitate differentiation and identification. The differentiation method may be, for example, different numbers or shapes of the identifiers in different embodiments.

[0152] In one embodiment, see Figure 8aThis application provides a nebulized drug delivery system, comprising: an infusion device for supplying a fluid containing a therapeutic substance, the fluid including a liquid phase fluid and a gas phase fluid, at least one of the two phase fluids containing the therapeutic substance; a nebulizing conduit connected to the infusion device for receiving the fluid and outputting it into the bronchus after nebulization; a sampling device for collecting the state parameters of the fluid; and a control device connected to the sampling device for receiving the state parameters and controlling the infusion device accordingly.

[0153] The term "drug administration" as used in the embodiments of this application refers to the delivery of a therapeutic substance to the lesion site. Details of the therapeutic substance can be found in the descriptions of other embodiments. The nebulizing catheter is also described in the embodiments of this application. A fluid containing the therapeutic substance enters the nebulizing catheter through an infusion device until it is applied to the lesion site in the body environment. The infusion device primarily provides fluid power, achieving a certain flow rate that can be adjusted as needed. For example, a controllable fluid delivery pump can be used. Existing technologies can also be employed regarding the pump's structure and control method. The infusion device is configured according to the fluid state and type, and control devices are installed at the points requiring control. The fluid loaded with the therapeutic substance can be pre-prepared or mixed in real-time with the fluid's movement. The therapeutic substance itself depends on the treatment purpose and the lesion condition; for example, the therapeutic substance may be a fluid itself, loaded with a gaseous fluid, or loaded with a liquid fluid. The nebulizing catheter can also deliver multiphase fluids, such as a fluid including both gaseous and liquid phases. Preferably, the two phases enter the nebulizing catheter separately and are then mixed and atomized at the nebulizer head. To facilitate the operation of the nebulizing catheter, in one embodiment, the nebulization drug delivery system further includes an auxiliary device that acts on the nebulizing catheter to change the relative position of the nebulizing catheter and the lesion site.

[0154] See Figure 8b The infusion device includes a first infusion device and a second infusion device. The microfluidic chip has multiple inlets, at least one of which is a gas phase inlet and at least one of which is a liquid phase inlet. The first infusion device includes a cylinder, a piston, and a drive mechanism. The cylinder is used to supply liquid fluid and has an outlet connected to the liquid phase inlet; the piston is slidably mounted on the cylinder; and the drive mechanism pushes the piston.

[0155] The first infusion device can be, for example, an infusion pump equipped with a syringe, the barrel can be, for example, the syringe barrel, the piston can be, for example, the plunger of the syringe, and the drive mechanism can be, for example, a stepper motor, which pushes the piston to move linearly to realize the drug delivery of the first infusion device. In use, the liquid flow rate can be maintained at 1~4.5 ml / min, for example, 3 ml / min. The thrust applied to the piston is 80~200 Newtons, and based on the cross-sectional area of ​​the piston, the converted liquid pressure is 0.2~0.76 MPa, for example, 0.4 MPa.

[0156] The second filling device includes an air compressor and / or an air cylinder, at least one of which is used to supply the gaseous fluid and is connected to the gas inlet. When using an air compressor, the air is compressed to 1.5–2 bar, which is the necessary pressure for the gaseous fluid; when using an air cylinder, the pressure inside the cylinder only needs to be higher than the pressure required for the gaseous fluid. The gaseous fluid pressure is 0.15–0.4 MPa, for example, 0.2 MPa.

[0157] The first injection device is connected to one of the inner tubes, and the second injection device is connected to the other inner tube. Taking the first inner tube 950 for transporting liquid fluid as an example, the first inner tube 950 of the tube body is connected to the first injection device, and the second inner tube 960 is connected to the second injection device, and vice versa.

[0158] The first injection device, via, as follows Figure 8b The first interface shown connects to the first inner tube 950, and the second filling device connects to the second inner tube 960 via the second interface. A quick-release connector is provided at the interface between the second inner tube 960 and the second filling device. When the second filling device uses an air compressor bottle, connecting it to the air compressor bottle via the quick-release connector enhances portability and facilitates quick replacement. The air compressor bottle can have a capacity of, for example, 500ml to 1L, a pressure of 0.2 MPa, and can be made of, for example, metal. A regulating valve can be installed on the pipeline connected to the second inner tube 960, and the control device regulates the pressure of the gaseous fluid inside the second inner tube 960 via the regulating valve.

[0159] The sampling device can collect relevant parameters as needed for control purposes. The fluid state parameters include at least one of temperature, pressure, and flow rate. To assist operation, the sampling device also collects image signals and / or state signals of the lesion site. Image signals facilitate visualization and can serve as real-time references and comparisons, while state signals of the lesion site can reflect the treatment progress, such as electrical signals like current and impedance, or temperature. To monitor the patient's physiological state during treatment, the sampling device also collects physiological signals, such as at least one of electrocardiogram (ECG) and blood signals.

[0160] As a nebulized drug delivery system, it may involve multiple specific devices. In order to know the status of each device and use it as a basis for monitoring or control, the sampling device also collects the operating status of related devices, such as the operating status of the infusion device and / or the sampling device. Depending on the specific device, this could include speed, operating current, operating temperature, pressure, etc.

[0161] See Figures 8b-8cThe sampling device includes a liquid phase sampling device and a gas phase sampling device. The liquid phase sampling device includes a position detector and a thrust detector. The control device receives signals from the liquid phase sampling device and can use them for feedback control of the first infusion device; it also receives signals from the gas phase sampling device and can use them for feedback control of the second infusion device. The position detector detects the piston position; the thrust detector detects the piston's pushing force, or, in other words, the resistance of the syringe during operation; the control device receives signals from the position detector and the thrust detector and controls the drive mechanism accordingly. The detectors can be the sensors mentioned below, and other descriptions are similar.

[0162] Given the varying piston resistance values ​​of different syringes, the first infusion device utilizes several specified types of syringes. A control device identifies the syringe type and accordingly drives the control mechanism. Specifically, after identifying the syringe model and capacity, the control device adjusts and obtains the flow rate of the liquid fluid in the first infusion device through signal feedback from the thrust detector. This flow rate is then used to control the drive mechanism, thereby regulating the liquid fluid flow rate. By obtaining the piston position at different times and detecting the syringe's travel distance, the flow rate delivered by the first infusion device is obtained. The thrust detector can, for example, be fixedly installed between the drive mechanism and the piston.

[0163] The gas phase sampling device includes a pressure detector for detecting the gas phase fluid pressure, and a control device for receiving signals from the pressure detector and controlling the gas phase fluid pressure accordingly. If the second filling device uses an air compressor, the control device detects the state parameters of the gas phase fluid, uses closed-loop feedback to control the speed of the air compressor, and adjusts the pressure of the gas phase fluid delivered by the air compressor. If the second filling device uses an air cylinder, the control device controls the gas phase fluid pressure through a regulating valve. It can be understood that the gas phase fluid pressure is only one aspect, and adjusting the pressure includes adjusting the flow rate of the gas phase fluid. Furthermore, the gas phase sampling device can also be equipped with a flow detector for detecting the output gas phase fluid flow rate.

[0164] The nebulized drug delivery system also includes a protection device, comprising a limit position detector, a temperature detector, and a cooling fan. Each part of the protection device prevents malfunction of the first and second infusion devices. The limit position detector detects the piston's extreme positions within the cylinder. The control device receives signals from the limit position detector and controls the drive mechanism accordingly to prevent damage to the equipment. The temperature detector monitors the air compressor's operating temperature; the cooling fan regulates the air compressor's operating temperature, and the control device receives information from the temperature detector and controls the cooling fan accordingly. The protection device also includes an alarm. If the second infusion device uses an air cylinder, the control device monitors the gas pressure of the gas phase fluid via a pressure detector; if the pressure is insufficient, the control device issues an alarm.

[0165] See Figure 8c Each detector can be implemented using a corresponding scheme. For example: the position detector is implemented using a sliding rheostat; the extreme position detector is implemented using an infrared limit sensor; the thrust detector is implemented using a syringe thrust sensor; the air compressor is implemented using an air compression pump; the temperature detector is implemented using a temperature sensor of the air compression pump; and the air pressure detector is implemented using an air pressure sensor. The control device includes a main board and a compressed air pump control main board, wherein the main board detects the data from the above detectors and controls the working status of the stepper motor, compressed air pump, and cooling fan accordingly.

[0166] The control device can also be used to convert the detection results of position detectors, thrust detectors, limit position detectors and pressure detectors into fluid state parameters, such as the flow rate and flow volume of liquid fluids and gaseous fluids, and output video and audio directly or after processing.

[0167] For example, nebulizer delivery systems also include, Figure 8a The display device shown can also be equipped with touch functionality. The control device receives touch signals from the display device and adjusts the operating mode accordingly, such as adjusting the flow rate of the liquid phase fluid and the gas pressure of the gas phase fluid. The display device can, for example, use a capacitive touchscreen for human-machine interaction, system operating status indication, displaying the current gas phase fluid pressure, the current liquid phase fluid flow rate, and the flow rate of the liquid phase fluid already delivered.

[0168] Reference Appendix Figure 10 To be continued Figure 24 In the illustrated embodiment, this application also discloses a gas-liquid two-phase atomization device, wherein the atomization device includes:

[0169] The device comprises a housing 500, on which a gas path connector 501 and a liquid path connector 502 are mounted. A pump chamber 510 is located at the bottom of the housing 500. Multiple air pumps 520 are installed in the pump chamber 510 and connected to the gas path connector 501 via a main pipe 511. A cooling assembly 530 is thermally coupled to the air pumps 520. A syringe 600 includes a cylinder 610 installed within the housing 500 and a piston 620 slidably installed within the cylinder 610. The cylinder 610 has an outlet and is connected to the liquid path connector 502. A drive mechanism 700 is linked to the piston 620 of the syringe 600. The gas-liquid two-phase atomization device of this application can be divided into a gas path section and a liquid path section, both of which enter the atomization conduit via the gas path connector 501 and the liquid path connector 502, respectively. For a better understanding of the technical solution of this application, the two parts will be explained separately below.

[0170] First, the structure of the air passage will be explained, please refer to the appendix. Figure 10 To be continued Figure 22Publicly available atomizing devices include:

[0171] The housing 500 has an air connector 501 installed on it, and a pump chamber 510 is provided at the bottom inside the housing 500.

[0172] Air pump 520 is installed in pump room 510. There are multiple air pumps 520 connected in parallel and the air outlet of each air pump 520 is connected to air connector 501 through main pipe 511.

[0173] Pressure relief valve 512 is installed on main pipe 511, and the outlet of pressure relief valve 512 is connected to pump room 510 through pipeline;

[0174] Cooling fan 531 is thermally coupled to air pump 520.

[0175] As described above, the air pump 520 can be directly mounted on the housing 500 or located within the pump chamber 510 inside the housing 500. The pump chamber can be independently configured with its own walls, or, as shown in the attached drawings, at least a portion of the housing can serve as the walls of the pump chamber. The pump chamber provides a relatively enclosed space, thereby improving the stability of the air pump's operation. In this embodiment, the air pump 520 provides the air source, thus realizing the function of the air path. In practical use, the inventors found that medical pneumatic equipment needs to meet oil-free requirements, leading to dry friction within the pump body of the air pump 520, resulting in relatively severe heat generation and affecting its lifespan. Simultaneously, while shielding is generally used to reduce noise, this can lead to the inability to form an effective airflow or a small air outlet, causing temperature rise. Furthermore, under certain special high-pressure requirements of consumable instruments, the air pump 520 experiences excessive temperature rise and overload; the combination of these factors results in excessive heat generation after prolonged operation, affecting the air pump 520's output pressure or significantly impacting the instrument's lifespan. To overcome these problems, this application has optimized heat dissipation. Referring to the embodiment shown in the accompanying drawings, the cooling fan 531 is disposed outside the pump chamber 510. A heat dissipation window 532 is provided on the side wall of the pump chamber 510 for the cooling airflow of the cooling fan 531 to pass through. Inside the pump chamber 510, a heat exchanger 533 is provided, thermally coupled to the air pump 520. At least a portion of the heat exchanger 533 is aligned with the heat dissipation window 532, meaning at least a portion of the heat exchanger 533 is exposed to the chamber wall of the pump chamber 510. In the drawings, the heat exchangers 533 are arranged in groups, with at least two heat exchangers 533 per group, and an airflow slit 534 is provided between them. The airflow slit 534 is aligned with the heat dissipation window 532 and the cooling fan 531. Optionally, each heat exchanger 533 in a group may correspond to a different air pump 520 or different pump heads of a single air pump 520. In the drawings, the air pump 520 is configured with dual pump heads, and the two heat exchangers 533 correspond to different pump heads, which can improve heat exchange efficiency. The heat exchanger 533 can be made of a material with high thermal conductivity, or its heat exchange efficiency can be improved by increasing its surface area. Alternatively, as shown in the attached embodiment, the heat exchanger 533 is a thermoelectric cooler with its cold end thermally coupled to the pump head of the air pump 520, while its hot end is exposed to the heat dissipation window 532. The cold end is attached to the heat sink of the air pump 520 body, and the hot end can be cooled by a heat sink or directly by airflow, with heat being carried away from the thermoelectric cooler by blowing / suction. Closed-loop control can also be achieved by using a temperature sensor. For example, a temperature sensor can be installed on the air pump 520. When the temperature is too high, the operating power of the thermoelectric cooler increases, i.e., the current of the thermoelectric cooler increases; conversely, the current decreases. This forms a closed loop, controlling the temperature of the air pump 520 within an efficient operating temperature range. If the temperature cannot decrease and exceeds a preset value, an alarm is triggered or the system is instructed to stop the pump.

[0176] The airflow direction of the cooling fan 531 needs to be combined with the airflow requirements inside the pump chamber 510. For example, when the heat exchanger 533 is made of a material with a high thermal conductivity, the cooling fan 531 can be selected to blow air to deliver cool air into the pump chamber 510, where it exchanges heat with the heat exchanger 533 and / or the pump head cooling fins of the air pump 520, and then is discharged through the air vent 503 at the bottom of the pump chamber 510.

[0177] For example, when the heat exchanger 533 is a thermoelectric cooler, if the cooling fan 531 continues to blow air, it may transfer the heat from the hot end of the thermoelectric cooler to the cold end, resulting in low heat exchange efficiency. In this case, the cooling fan 531 can choose to draw air to remove the hot air from the pump chamber 510. The air inlet 503 at the bottom of the pump chamber 510 acts as an air inlet. The cold air enters the pump chamber 510 through the negative pressure inside the pump chamber 510 (generated by the suction of the cooling fan 531), exchanges heat with the heat exchanger 533 and / or the pump head heat sink fins of the air pump 520, and is then discharged by the cooling fan 531.

[0178] In addition to using a cooling fan, the air duct can also be established via a pressure relief duct, as described in the embodiments below. In the field of medical devices, the amount of gas used is generally small, but maintaining a high pressure requires the air pump 520 to remain operational, causing inconvenience. In this embodiment, the output airflow of the air pump 520 enters the pressure relief valve 512 via the main pipe 511. The pressure relief valve 512 is connected to at least an output pipe 5121 leading to the air passage connector 501 and a pressure relief duct 5122 leading to the pump chamber 510. Excess gas is discharged through the pressure relief valve 512 using a waste gas bypass method, utilizing the waste gas to cool the air pump 520 without requiring power, thus improving the miniaturization of the device. The airflow from the pressure relief duct 5122 enters the pump chamber 510, creating positive pressure. The hot air inside the pump chamber is discharged through the ventilation port 503 at the bottom of the device and / or the cooling fan 531, carrying away heat. In this embodiment, the cooling fan 531 can either blow air into the pump chamber 510 to assist in creating a positive pressure environment, or it can draw air from the pump chamber 510 to assist in the outflow of gas. The specific choice can be set according to the operating power of the cooling fan 531 and the air delivery volume of the pressure relief duct 5122.

[0179] In this embodiment, a positive pressure is created using a pressure relief duct 5122, and a cooling fan 531 draws in air. The main consideration for this design is that medical pumps used in this field are very small in size and are often treated with sound insulation materials, resulting in a small internal space and narrow air duct within the air pump 520's isolation enclosure. Using an air duct under the axial fan creates a small cross-sectional area air duct with a high flow rate, meeting practical usage requirements and satisfying heat dissipation needs. Furthermore, the airflow strength is related to the pump's operating power, which is related to the pump's heat generation, and therefore exhibits a relatively linear relationship. In actual control, pressure can be detected by the air pressure transmitter 522 to determine whether the output pressure of the air pump 520 meets the standard. Based on the pressure signal, the speed of the motor 702 is adjusted to perform closed-loop control of the pressure. The gas flows through the pressure relief valve 512, and the excess gas is discharged after being silenced at the outlet. A corresponding hose is connected here, and the gas flows into the pressure relief air pipe 5122 through the four-way interface 5123 (or it can be diverted to multiple points depending on the matching degree of the air pump 520 and consumables) and connected to the pump room 510.

[0180] In terms of specific structure, the pressure relief valve 512 can be controlled by elastic elements, such as by using a spring to press the valve, and releasing pressure when the pressure is too high, thereby achieving automatic over-control. Alternatively, it can be controlled by an electrically controlled valve to achieve precise control.

[0181] In addition to enhanced heat dissipation, this embodiment improves working efficiency and stability by using multiple air pumps 520 operating in tandem. Various combinations are possible in actual operation. For example:

[0182] The dual pumps work at low pressure simultaneously to provide the final output high pressure: Since the parameters of the consumables (atomizing tube) at the front end are variable, it is sometimes necessary to increase the upper limit pressure of the air pump 520, that is, close to the full load working pressure of 0.2mPa. The dual pumps in parallel input mode each provide a certain low flow rate, which is collected by the three-way check valve at the back end and sent to the main pipe 511 to generate the working pressure requirement, which greatly reduces the utilization factor of each unit.

[0183] Dual pumps working separately extend service life: When the working pressure is low, using one pump per operation will not cause the temperature to rise continuously and affect the equipment. In addition, if one pump fails, the other can be used as a backup to prevent downtime, and an alarm will be triggered.

[0184] The air pump 520 can be controlled by the air pressure transmitter 522. By controlling the speed of the brushless motor 702 of each air pump 520, the pressure generated by the pump body movement is controlled within a required temperature range, thus extending the service life.

[0185] In this embodiment, the stability of the air circuit operation is effectively improved by optimizing the heat dissipation settings and the control logic optimization of multiple air pumps 520 operating in tandem.

[0186] Besides the operational stability issues mentioned above, the noise and vibration of the air pump 520 also present problems in actual use. (See attached reference.) Figure 13 In the illustrated embodiment, a sound-absorbing baffle 513 is provided on the inner sidewall of the pump chamber 510. The baffle is attached to the sidewall of the pump chamber 510 or spaced apart from the sidewall of the pump chamber 510. The sound-absorbing baffle 513 can be made of a highly elastic or complex surface sound-absorbing material (such as environmentally friendly sponge, made of various porous sound-absorbing materials such as rock wool, plant fiber spraying, etc., to absorb noise), or it can be made of a high-density sound-absorbing material, or a high-damping shock-absorbing material, or it can even be combined with the sidewall of the pump chamber 510 (for example, the sidewall of the pump chamber 510 is treated with a double layer, a vacuum is drawn, and a getter such as a composite getter composed of barium aluminum alloy and zirconium aluminum is added between the double layers to reduce the medium for sound transmission).

[0187] In addition, the above problems can be overcome by installing shock absorption devices. (See attached reference) Figure 17 To be continued Figure 21 In the illustrated embodiment, the air pump 520 is connected to the housing 500 via a secondary vibration damping device 514, which includes:

[0188] Several first buffer blocks 5141 are disposed on the housing 500;

[0189] The primary shock absorption platform 5142 is supported by each first buffer block 5141;

[0190] Several second buffer blocks 5143 are set on the primary shock absorption platform 5142 and connected to the air pump 520.

[0191] The second buffer block 5143 has a lower hardness than the first buffer block 5141, effectively blocking the transmission of vibration between the air pump 520 and the housing 500. For specific structural details, please refer to the attached diagram. Figure 19a The second buffer block 5143 is a thin-walled cylindrical structure, with a first mounting groove 5144 and a second mounting groove 5145 at the top and bottom for the mounting feet of the primary damping platform 5142 and the air pump 520 to engage. In terms of overall dimensions, the outer diameter of the first buffer block 5141 is approximately 11 mm, the buffer spacing between the first mounting groove 5144 and the second mounting groove 5145 is approximately 8 mm, and the wall thickness of the cylindrical portion between the first mounting groove 5144 and the second mounting groove 5145 is approximately 1 mm. In terms of overall shape, the second buffer block 5143 is a long cylindrical shape, meaning its axial length is slightly greater than its radial length, thus providing greater deformation space to absorb vibrations.

[0192] In the attached diagram, the second buffer block 5143 can be tilted relative to a shock-absorbing platform 5142. In principle, the line connecting the center of the upper surface and the middle of the lower surface of the second buffer block 5143 is the working line. When the second buffer block 5143 is tilted, the working line will form an angle with the direction of gravity. In the above configuration, this angle can reach 20 degrees or even 30 degrees, thereby effectively releasing the vibration energy of the air pump 520.

[0193] However, excessive tilting of the second buffer block 5143 may reduce the installation stability of the air pump 520. Therefore, this problem can be avoided by adjusting the structural parameters of the second buffer block 5143. For example, each second buffer block 5143 can have directional characteristics, thereby ensuring the spatial stability of the air pump through force coupling in different directions. Ideally, the second buffer block 5143 should only receive its own axial load. To avoid unexpected situations and improve robustness, a buffer zone can be set between the air pump 520 and surrounding components to prevent component interference caused by the tilting of the second buffer block 5143. Especially when using dual air pumps arranged side by side, the spacing between the air pumps should be ensured to avoid interference.

[0194] In the actual product, the first buffer block 5141 can be a cylindrical rubber pad, made of NR, SBR, or CR. Due to the viscoelastic properties of rubber, it has good shock absorption, sound insulation, and cushioning performance. According to tests, it can effectively reduce vibration transmission to the housing 500 by 60%. A relatively thick, high-density rubber material is used to fix and support the primary shock absorption platform 5142 and the second buffer block 5143. The second buffer block 5143 adopts a hollow rubber column structure with a wall thickness of approximately 2mm under no-load. In one embodiment, the hardness of the second buffer block 5143 is less than that of the first buffer block 5141, and the spatial movement freedom of the second buffer block 5143 is greater than that of the first buffer block 5141. A softer rubber material is also used to increase flexibility. It is fixed by a slip-fitting method on both sides, with no restriction on the degree of freedom, which can eliminate 80% of the vibration.

[0195] After actual testing, the vibration reduction effect of the secondary damping device 514 in this embodiment can be reduced to 8% of the original effect (40%*20%=8%), and the noise can also be largely eliminated.

[0196] Furthermore, a third buffer block 5001 can be installed at the bottom of the casing 500 to further reduce noise and vibration.

[0197] In other embodiments, a gas cylinder 523 can also be used to provide the gas source. Compared to the air pump 520 solution, the gas source in this embodiment has less noise and lower energy consumption. The control device can control the air pressure and airflow through a solenoid valve 524. The gas cylinder 523 can be connected to a pressure regulating valve 525 for pressure adjustment. At the same time, the control device can detect the amount of gas in the gas cylinder 523, thereby reminding the user to replace the gas cylinder 523 when the gas content is insufficient. Other settings can refer to the atomizing device with an air pump mentioned above, and will not be repeated here.

[0198] The structural optimization of the air pump 520 and pump chamber 510 is to provide a good working foundation for the operation of the air circuit section. The function of the air circuit section is to provide a stable and reliable air source to work in conjunction with the liquid circuit section. Referring to the embodiment shown in the attached drawings, the housing 500 is also equipped with a liquid circuit connector 502 and a fixing base 701; an adapter 630 is detachably connected to the fixing base 701; the adapter 630 is used to movably insert the barrel 610 of the syringe 600, the syringe 600 includes a barrel 610 and a piston 620 slidably installed in the barrel 610, the barrel 610 has an outlet and communicates with the liquid circuit connector 502; the piston 620 of the syringe 600 is linked to a drive mechanism 700, the liquid fluid output from the liquid circuit connector 502 and the gaseous fluid output from the air circuit connector 501 mix to form a gas-liquid two-phase flow, and the gas-liquid two-phase flow is atomized to achieve drug delivery.

[0199] As described above, this application discloses an atomizing device, comprising: a housing 500, on which an air connector 501 and a liquid connector 502 are installed, and a pump chamber 510 is provided at the bottom inside the housing 500; an air pump 520 installed in the pump chamber 510, wherein multiple air pumps 520 are connected in parallel and are connected to the air connector 501 through a main pipe 511; a pressure relief valve 512 installed in the main pipe 511, the outlet of the pressure relief valve 512 being connected to the pump chamber 510 through a pipeline; a cooling fan 531 thermally coupled to the air pump 520; a syringe 600, comprising a cylinder 610 installed in the housing 500 and a piston 620 slidably installed in the cylinder 610, the cylinder 610 having an outlet and being connected to the liquid connector 502; and a drive mechanism 700, which is linked to the piston 620 of the syringe 600.

[0200] Similarly, this application discloses an atomization system, comprising:

[0201] The housing 500 has an air connector 501 installed on it, and a pump chamber 510 is provided at the bottom inside the housing 500.

[0202] Air pump 520 is installed in pump room 510. Multiple air pumps 520 are connected in parallel and connected to air line connector 501 through main pipe 511.

[0203] Pressure relief valve 512 is installed on main pipe 511, and the outlet of pressure relief valve 512 is connected to pump room 510 through pipeline;

[0204] Cooling fan 531 is thermally coupled to air pump 520;

[0205] The syringe 600 includes a barrel 610 installed in a housing 500 and a piston 620 slidably installed in the barrel 610. The barrel 610 has an outlet and communicates with a liquid connection 502.

[0206] The drive mechanism 700 is linked to the piston 620 of the syringe 600;

[0207] A nebulizing conduit includes a tube body, one end of which is a proximal end and the other end is a distal end that can extend into the bronchus. The proximal end is connected to the gas path connector and the liquid path structure. The tube body has a channel inside that can deliver fluid from the proximal end to the distal end. An nebulizing head is provided at the distal end of the tube body. A microfluidic chip is disposed inside the nebulizing head. The fluid in the channel is atomized and output after being atomized by the microfluidic chip.

[0208] Referring to the embodiment shown in the accompanying drawings, the gas-liquid two-phase flow is used to deliver fluid to the atomizing conduit. The atomizing conduit includes a tube body, one end of which is a proximal end and the other end is a distal end that can extend into the bronchus. The tube body has a channel inside that can deliver fluid from the proximal end to the distal end. An atomizing head is provided at the distal end of the tube body. A microfluidic chip is disposed inside the atomizing head. The fluid in the channel is atomized by the microfluidic chip and then output. A distribution structure capable of acting on at least a portion of the fluid is provided inside the microfluidic chip.

[0209] Referring to the embodiment shown in the attached drawings, the drive mechanism, except for the motor portion located on the front panel of the housing, is entirely situated on one side of the control panel. This arrangement facilitates syringe installation and observation. The motor of the drive mechanism is located inside the housing, which is advantageous for noise and vibration control. The gas phase components are also located inside the housing, facilitating noise control and tubing arrangement. Overall, the drive mechanism has a figure-7 layout, with the electrodes located at the bottom of the housing. Correspondingly, the gas path is situated within the blank space of the figure-7 layout of the drive mechanism, with the air pump positioned near the electrodes. This arrangement helps lower the center of gravity, increase layout density, and thus control product volume. The gas and liquid connection connectors are close to each other and positioned below the control panel, allowing for centralized operation of the control area and facilitating medical personnel's work.

[0210] The technical features of the embodiments described above can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be regarded as the drawing also disclosing examples of combinations of the various embodiments involved.

[0211] The embodiments described above are merely examples of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these modifications and improvements all fall within the protection scope of this application.

Claims

1. A nebulizer for treating lung diseases, characterized in that, include: Pump room; An air pump is located in the pump chamber. The air pump has an air inlet and an air outlet, and the air inlet and the air outlet are respectively connected to the outside of the pump chamber through corresponding pipes. The air outlet is connected to an air circuit connector. The atomizing device also includes a pressure relief valve installed on the main pipe of the air pump. The outlet of the pressure relief valve is connected to the pump chamber through a pressure relief duct. The pressure relief valve is provided with a pressure relief duct connected to the pump chamber to use exhaust gas to dissipate heat from the air pump. A heat exchanger is located in the pump chamber and thermally coupled to the air pump, with at least a portion of the heat exchanger exposed to the chamber wall of the pump chamber; A cooling fan is installed outside the pump chamber and thermally coupled to the heat exchanger. The pressure relief duct creates a positive pressure environment inside the pump chamber, and the cooling fan draws air out of the pump chamber to form a circulating air duct. The top wall of the pump chamber has a heat dissipation window through which the cooling airflow of the cooling fan passes. At least a portion of the heat exchanger is aligned with the heat dissipation window. The bottom wall of the pump chamber has an air vent. One end of the heat exchanger is thermally coupled to the pump head of the air pump and is attached to the heat sink of the pump head. The other end is exposed to the heat dissipation window. The cooling airflow enters the pump chamber through the air vent, exchanges heat with the heat exchanger and the pump head of the air pump, and is then discharged through the cooling fan.

2. The nebulizer for treating lung diseases according to claim 1, characterized in that, The atomizing device also includes a housing, the pump chamber is located at the bottom inside the housing, at least a portion of the housing serves as the wall of the pump chamber, or the wall of the pump chamber is independently configured; The air passage connector is installed on the housing, and the air pumps are multiple units connected in parallel, with the air outlet of each air pump connected to the air passage connector through a main pipe.

3. The nebulizer for treating lung diseases according to claim 1, characterized in that, The heat exchange components are arranged in groups, and each group of heat exchange components has at least two pieces with an airflow slit between them. The airflow slit is aligned with the heat dissipation window and the cooling fan.

4. The nebulizer for treating lung diseases according to claim 3, characterized in that, The heat exchanger is a semiconductor cooling chip with its cold end thermally coupled to the pump head of the air pump, its hot end exposed to the heat dissipation window, and its cold end attached to the heat dissipation fins of the air pump body.

5. The nebulizer for treating lung diseases according to claim 4, characterized in that, A temperature sensor is installed on the air pump, and the semiconductor cooling chip, the air pump, and the pressure relief valve are controlled by the temperature sensor to achieve closed-loop control.

6. An atomization system, based on the atomization device according to any one of claims 1 to 5, wherein the atomization device further comprises... A syringe, comprising a barrel mounted within a housing and a piston slidably mounted within the barrel, the barrel having an outlet and communicating with a fluid connection. The drive mechanism is linked to the piston of the syringe; A nebulizing conduit includes a tube body, one end of which is a proximal end and the other end is a distal end that can extend into the bronchus. The proximal end is connected to the gas path connector and the liquid path connector. The tube body has a channel inside that can deliver fluid from the proximal end to the distal end. An nebulizing head is provided at the distal end of the tube body. A microfluidic chip is disposed inside the nebulizing head. The fluid in the channel is atomized and output after being atomized by the microfluidic chip.

7. The atomization system according to claim 6, characterized in that, The atomizing device includes The pump chamber has a sound-absorbing baffle on its inner wall; The air pump; The secondary damping device includes: Several first buffer blocks are disposed inside the housing; The primary shock absorption platform is supported by each first buffer block; Several second buffer blocks are set on the primary shock absorption platform and support the air pump.

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