Interventional catheters, interventional devices, and nebulized drug delivery systems

Abstract

This application relates to interventional catheters, interventional devices, and nebulized drug delivery systems. The interventional catheter includes a tube body with a proximal end and a distal end extending into the bronchus. The tube body contains a microfluidic chip, which has: a first fluid inlet located on the proximal side of the microfluidic chip; two second fluid inlets distributed on opposite sides of the microfluidic chip; and an outlet located on the distal side of the microfluidic chip. The interior of the microfluidic chip contains chip channels connecting the outlet and each fluid inlet. These chip channels include: a main channel connected to the first fluid inlet at one end and the outlet at the other; and side channels connected to the second fluid inlet at one end and the main channel at the other. The side channels contain multiple spaced-apart distribution elements. This application achieves nebulization of the delivered fluid through the microfluidic chip, improving the nebulization effect.

Description

Technical Field

[0001] This application relates to the field of nebulization technology, and in particular to interventional catheters, interventional devices, and nebulized drug delivery systems. 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 efficient inhalation and absorption. However, during inhalation, it's difficult for all the medication to reach the lesion, resulting in unnecessary loss. Furthermore, inhalation also presents the risk of potential safety hazards, as the medication may damage organs along its route before reaching the lesion due to its own side effects.

[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 an interventional catheter, including a tube body, one end of which is a proximal end and the other end which is a distal end that can extend into the bronchus. The tube body contains a microfluidic chip, which has the following characteristics:

[0005] The first fluid inlet is located on the proximal side of the microchannel chip;

[0006] There are two second fluid inlets, which are distributed on two opposite sides of the microchannel chip.

[0007] The outlet is located on the distal side of the microfluidic chip;

[0008] The interior of the microchannel chip is a chip flow channel connecting the outlet and each fluid inlet, and the chip flow channel includes:

[0009] The main channel is connected to the first fluid inlet at one end and to the outlet at the other end;

[0010] The side flow channel is connected to the second fluid inlet at one end and to the main flow channel at the other end. The side flow channel is provided with a plurality of spaced distribution components.

[0011] Optionally, there are two side channels, which are symmetrically distributed on both sides of the main channel, and each side channel is connected to the middle and lower reaches of the main channel.

[0012] Optionally, the side channel has a distal bend at the second fluid inlet, and at the end of the bend and on the side facing the main channel, it is connected to the main channel via a junction section.

[0013] The distribution components are arranged sequentially along the length of the main channel in the connecting section.

[0014] Optionally, the main channel is provided with a fluid acceleration structure and a sudden expansion section arranged sequentially according to the fluid flow direction, wherein the confluence section is connected to the sudden expansion section, and the connection part is adjacent to the fluid acceleration structure.

[0015] Optionally, the intersection segment includes multiple narrowing sections in sequence, and the distribution component is located between two adjacent sections.

[0016] Optionally, the narrowing section includes three levels, with the distribution element located between the first two levels.

[0017] Optionally, the overall extension direction of the intersection section is along the width direction of the main channel, and each narrowing part has two opposing sidewalls, with at least one sidewall arranged at an angle relative to the extension direction so that the narrowing part gradually narrows.

[0018] Optionally, one of the two sidewalls is parallel to the extending direction, while the other is arranged at an angle.

[0019] Optionally, in the two downstream stages, the inclined sidewalls are located on opposite sides of the flow channel.

[0020] Optionally, the flow channel width can vary by 20% to 60% before and after each narrowing stage.

[0021] Optionally, the distribution element is toothed in shape, and the cross-sectional dimensions of each distribution element gradually increase in the direction of fluid flow.

[0022] Optionally, on the downstream side of the distributor, the distributor occupies 30 to 70% of the width of the flow channel.

[0023] This application also discloses an atomized drug delivery system, comprising:

[0024] 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;

[0025] The interventional catheter, using the interventional catheter in the above technical solution, has its proximal end connected to the perfusion device for receiving gaseous fluid and liquid fluid respectively;

[0026] A sampling device used to collect the state parameters of a fluid;

[0027] The control device, connected to the acquisition device, is used to receive status parameters and control the injection device accordingly.

[0028] This application also discloses a gas-liquid two-phase interventional device, including:

[0029] The housing is equipped with air and liquid connectors, and a pump chamber is located at the bottom inside the housing.

[0030] The air pump is installed in the pump room. Multiple air pumps are connected in parallel and connected to the air circuit connector through a main pipe.

[0031] Cooling components, thermally coupled to the air pump;

[0032] 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.

[0033] The drive mechanism is linked to the piston of the syringe;

[0034] The interventional catheter, using the interventional catheter in the above technical solution, has its proximal end connected to the gas circuit connector and the liquid circuit connector, respectively, for receiving gaseous fluid and liquid fluid.

[0035] 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

[0036] Figures 1a to 1c This is a schematic diagram of the structure of an interventional catheter in one embodiment of this application;

[0037] Figures 2a to 2d This is a schematic diagram of a microchannel chip structure in one embodiment of this application;

[0038] Figures 3 to 6 This is a schematic diagram of the interventional device in one embodiment of this application.

[0039] The annotations in the figure are explained as follows:

[0040] 900, Tube body; 901, Proximal end; 902, Distal end; 9061, Communication interface; 907, First interface; 908, Second interface;

[0041] 920. Microfluidic chip; 921. First unit chip; 922. Second unit chip;

[0042] 940. Sheath; 941. Balloon; 942. Balloon catheter; 943. Balloon control interface; 944. Heating assembly;

[0043] 130. Main flow channel; 140. Side flow channel; 1401. Sidewall; 1402. Sidewall; 1403. Sidewall; 1404. Sidewall; 141. First-stage narrowing; 142. Second-stage narrowing; 143. Third-stage narrowing;

[0044] 300. Branch flow channel;

[0045] 400. Distribution component; 460. Fluid acceleration structure; 461. Narrow opening; 462. Sudden expansion section;

[0046] 500. Housing; 501. Gas connection; 502. Liquid connection;

[0047] 510. Pump room; 511. Main pipe; 512. Pressure relief valve; 5122. Pressure relief duct; 5123. Four-way connector; 513. Soundproof partition; 514. Secondary damping device; 5141. First buffer block; 5142. Primary damping platform; 5143. Second buffer block;

[0048] 520. Air pump; 5211. First filter;

[0049] 530. Cooling components; 531. Cooling fan; 532. Heat dissipation window; 533. Heat exchanger; 534. Airflow slit;

[0050] 600. Syringe; 700. Drive mechanism; 800. Control panel. Detailed Implementation

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] Referring to the accompanying drawings, this application discloses an interventional catheter, including a tube body 900, one end of which is a proximal end 901, and the other end is a distal end 902 that can extend into the bronchus. The tube body 900 contains a microfluidic chip 920, which has the following characteristics:

[0056] The first fluid inlet 111 is located on the proximal end 901 side of the microchannel chip 920;

[0057] There are two second fluid inlets 112, which are distributed on two opposite sides of the microchannel chip 920.

[0058] The outlet 120 is located on the distal end 902 side of the microfluidic chip 920;

[0059] The interior of the microfluidic chip 920 is a chip flow channel connecting the outlet 120 and each fluid inlet 110. The chip flow channel includes:

[0060] The main channel 130 is connected to the first fluid inlet 111 at one end and to the outlet 120 at the other end.

[0061] The side flow channel 140 is connected to the second fluid inlet 112 at one end and to the main flow channel 130 at the other end. Multiple distribution components 400 are arranged at intervals inside the side flow channel 140.

[0062] In terms of configuration details, there are two side channels 140, symmetrically distributed on both sides of the main channel 130, with each side channel 140 connected to the middle and lower reaches of the main channel 130. Each side channel 140 has a turning point at the second fluid inlet 112, pointing towards the distal end 902. At the end of the turning point, on the side facing the main channel 130, it connects to the main channel via a confluence section. Distribution components 400 are arranged sequentially along the length of the main channel 130 in the connecting section. The main channel 130 is provided with a fluid acceleration structure 460 and a sudden expansion section 462 arranged sequentially according to the fluid flow direction, wherein the confluence section connects to the sudden expansion section 462, and the connecting portion is adjacent to the fluid acceleration structure 460. (See attached diagram) Figure 2d As shown, the junction section includes multiple narrowing stages, with the distribution component 400 located between adjacent stages. In terms of the narrowing mechanism, the flow channel width changes by 20-60% before and after each narrowing stage. This is specifically manifested as a change in the flow channel inner diameter. The narrowing process can be uniform or abrupt. It is worth noting that when comparing the flow channel inner diameter before and after narrowing, the flow channel width may increase during the process. For example, see attached... Figure 2d As shown, the narrowing section comprises three stages: a first-stage narrowing 141, a second-stage narrowing 142, and a third-stage narrowing 143, with the inner diameter decreasing sequentially. In the attached figure, the distributor 400 is located between the first-stage narrowing 141 and the second-stage narrowing 142. In the attached figure, the second-stage narrowing 142 expands before narrowing compared to the outlet of the first-stage narrowing 141. The main purpose of the expansion of the second-stage narrowing 142 is to provide more space at the rear end of the distributor 400, allowing the fluid to pass through the distributor 400 more smoothly.

[0063] Overall, the multi-stage narrowing design allows for phased adjustments to the fluid flow parameters and distribution effect. For example, the first-stage narrowing 141 in the attached diagram guides the fluid better onto the distributor 400, the second-stage narrowing 142 receives the fluid combed by the distributor 400 and further compresses and transports it, and the third-stage narrowing 143 further compresses and transports the fluid based on the second-stage narrowing 142 and adjusts the intersection angle between the fluid and the main flow channel, thereby achieving efficient and precise atomization of the fluid within the main flow channel 130 and the side flow channel 140.

[0064] The overall extension direction of the intersection section is along the 130mm width of the main road. Each narrowing section has two opposing sidewalls, at least one of which is inclined relative to the extension direction, causing the narrowing section to gradually constrict. Of the two sidewalls, one is parallel to the extension direction, and the other is inclined, for example, as shown in the attached... Figure 2dThe sidewalls 1401 and 1402 shown are arranged at an angle, while sidewalls 1403 and 1404 are parallel to the extending direction. The sidewalls parallel to the extending direction are designed to better counteract the atomization of the fluid in the main flow channel 130, while the sidewalls arranged at an angle are designed to better concentrate the fluid in the side flow channel 140. In the two downstream stages, the angled sidewalls are located on opposite sides of the flow channel. In the attached figures, this is specifically shown as sidewalls 1401 and 1402 being located on opposite sides of the flow channel. This arrangement can effectively regulate the direction of fluid movement, preventing the fluid direction from being deflected due to the narrowing structure. More importantly, it ensures the convergence angle between the fluid in the side flow channel 140 and the fluid in the main flow channel 130, guaranteeing the atomization effect.

[0065] In this embodiment, the distributor 400 is toothed in shape, and the cross-sectional size of each distributor 400 gradually increases in the fluid flow direction. Downstream of the distributor 400, it occupies 30-70% of the width of the flow channel. The distributor can manage turbulence in the fluid, improve the flow stability, ensure the stable operation of the atomization process, and control the distribution range of droplet size.

[0066] The fluid in the side channel 140 undergoes multi-stage narrowing and distribution 400 sorting, ensuring that it can smoothly and stably flow into the main channel 130 while maintaining the flow rate, and mix with the fluid in the main channel 130 to achieve a full atomization effect.

[0067] Reference Appendix Figure 1a To be continued Figure 1c As shown, this application also provides another interventional catheter, comprising:

[0068] The tube body 900 has a proximal end 901 at one end and a distal end 902 at the other end that can extend into the bronchus.

[0069] The microchannel chip 920 has a chip flow channel inside, which includes a main flow channel 130 and a side flow channel 140. The main flow channel 130 and / or the side flow channel 140 are provided with a fluid acceleration structure 460 and a sudden expansion section 462 arranged in sequence according to the fluid flow direction. The fluids in the main flow channel 130 and the side flow channel 140 interact in the sudden expansion section 462 and output atomized fluid.

[0070] The heating component 944 is located inside the tube 900 and at the distal end 902 of the microfluidic chip 920. It is used to regulate the temperature of the atomized fluid. After the microfluidic chip 920 outputs the atomized fluid, the heating component 944 heats the atomized fluid to the treatment temperature so that the atomized fluid with the treatment temperature can ablate the lesion.

[0071] The balloon 941 is deformably configured on the outside of the tube 900.

[0072] The balloon 941 can control its own shape, such as inflating or contracting, under the guidance of the balloon catheter 942, the balloon control interface 943, and the corresponding fluid delivery, thereby achieving occlusion, positioning, and corresponding operations at preset locations. This improves the stability and adaptability of interventional catheter operations.

[0073] In terms of setup details, along the axial direction of the tube body 900, the balloon 941 and the heating component 944 are positioned correspondingly. The distal end 902 of the microfluidic chip 920 has an outlet for atomized fluid output. The heating component 944 is a heating tube, the interior of which is a temperature control channel connected to the outlet. The heating temperature of the heating component 944 is preferably 43-60℃, at which temperature it can kill lesions (cancer cells) while allowing normal cells to recover. The interventional catheter also includes a first interface 907 and a second interface 908, which can be connected to an external perfusion device for delivering fluid to each inner tube. The interventional catheter also includes a communication interface 9061, through which signal and energy transmission can be achieved.

[0074] See appendix Figure 2a To be continued Figure 2c As shown in the attached figure, a microchannel chip 920 is disclosed, wherein the chip's aspect ratio ranges from 2.5 to 5, preferably from 3 to 4, and the aspect ratio shown in the figure is 2.5:0.9. The width of the main channel 130 is preferably 0.2 to 0.5 mm, and in actual products, it is preferably 0.25 to 0.45 mm, and in the attached figure, the width is 0.3 mm. The width of the main channel throat is smaller than the width of the main channel 130, and the width of the main channel throat is preferably 0.05 to 0.15 mm, and in actual products, it is preferably 0.08 to 0.12 mm, and in the attached figure, the width is 0.1 mm. The droplet outlet width W8 can be the same as the width of the main channel throat, or it can be set differently, for example, the droplet outlet width W8 can deviate from the width of the main channel throat by 5% to 15%. In the attached figure, the droplet outlet width W8 is preferably 0.15 mm. The width of the side channel 140 is preferably 0.1 to 0.3 mm, and in actual products, it is preferably 0.15 to 0.25 mm. In the attached drawing, the width of the side channel 140 is 0.2 mm. The distance between the side channel 140 and the proximal side of the microchannel chip 920 is preferably 0.5 to 1.8 mm, and in actual products, it is preferably 0.8 to 1.5 mm. In the attached drawing, the distance between the side channel 140 and the proximal side of the microchannel chip 920 is 1.3 mm. The width of the branch channel is preferably 0.01 to 0.05 mm, and in actual products, it is preferably 0.015 to 0.03 mm. In the attached drawing, the width of the branch channel is 0.02 mm.

[0075] In this embodiment, gas is transported in the main flow channel 130 and a fluid acceleration structure 460 is provided. The fluid acceleration structure 460 is located upstream of at least one junction of the main flow channel 130 and the side flow channel 140, and at least one narrow opening 461 is provided at this junction. The main flow channel 130 or the side flow channel 140 connects with the other through this narrow opening 461. Liquid is transported in the side flow channel 140, and a distribution structure is provided near one end of the main flow channel 130. The distribution structure consists of an array of distribution members 400, and the cross-sectional size of each distribution member 400 gradually increases in the fluid flow direction. A sudden expansion section 462 is provided downstream of the fluid acceleration structure 460 in the main flow channel 130. Figure 2c To better illustrate the expansion section 462, the extension trend of the fluid acceleration structure 460 is extended by dashed lines in the attached diagram. Compared to the extension trend of the fluid acceleration structure 460, it is clearly observable that the cavity diameter of the expansion section 462 is larger, indicating a larger internal volume. (The attached diagram is not included in the provided text.) Figure 2c The designations regarding the abrupt expansion section 462 and the fluid acceleration structure 460 are intended to better indicate the boundary between their approximate positions and do not limit their axial length, especially at their mutually distant ends. For example, as shown in the attached... Figure 2a In the embodiment shown, the axial lengths of the sudden expansion section 462 and the fluid acceleration structure 460 are relative to the attached... Figure 2c The extended section 462 is longer, with its distal side extending to the distal side of the chip and forming a droplet outlet.

[0076] In terms of proportion, the internal volume of the expansion section 462 is at least 15% larger than the internal volume of the fluid acceleration structure. A junction with a narrow opening 461 is located in the expansion section 462, which, in the accompanying drawings, is located near the proximal end of the expansion section 462. That is, the expansion section 462 is positioned against the fluid acceleration structure 460, and the cavity diameter of the expansion section 462 is at least 10% larger than the cavity diameter at the outlet of the fluid acceleration structure 460. In this embodiment, the design is based on the principle of differential pressure atomization. The gas is accelerated through the fluid acceleration structure and interacts with the liquid phase in the expansion section 462. The sudden expansion of the channel space in the expansion section 462 and the high-speed airflow work together to create a pressure difference. Through differential pressure atomization, the size of the small droplets is more concentrated, effectively improving the concentration of the droplet size distribution range after atomization. In this embodiment, the atomized droplet size distribution is in the range of 20–60 μm, with at least 70% distributed in the range of 20–40 μm.

[0077] Regarding the arrangement of the distribution structure, the distribution structure is at least one of the following: Method a: multiple branch channels 300 connected to the side channel 140, the side channel 140 intersecting with the main channel 130 via the multiple branch channels 300; Method b: multiple spaced or individually arranged distribution members 400 located in the main channel 130 and / or the side channel 140.

[0078] Regarding the fluid acceleration structure 460 and the sudden expansion section 462, the sudden expansion section 462 is formed by the expansion of the flow channel it resides in. In terms of transition, the sudden expansion section 462 and the outlet of the fluid acceleration structure 460 have a smooth transition or a stepped transition. It is worth noting that the emphasis here is on a smooth or non-smooth transition based on fluid dynamics design principles, in order to enhance or adjust the influence of the sudden expansion section 460 on fluid motion. For example, burrs, straight edges, steps, etc., formed by process limitations in common industrial products cannot be directly understood as a stepped transition here; similarly, conventionally chosen rounded corners cannot be directly understood as a smooth transition. The focus here is on deliberately manufacturing this shape. In the fluid direction corresponding to the flow channel, the expansion trend of the sudden expansion section 462 relative to the fluid acceleration structure 460 is also designed. Based on the overall size of the expansion section 462, when the size of the expansion section 462 is significantly larger than the opening size of the main channel, its expansion tendency will decrease at the distal end to achieve structural compatibility. When the size of the expansion section 462 is significantly smaller than the size of the droplet outlet, the expansion section 462 can choose to maintain its expansion tendency or further increase it. Besides size, the position of the expansion section 462 on the chip also matters. When the expansion section 462 is close to the droplet outlet, its axial expansion distance is limited. As the axial and radial expansion tendencies of the expansion section 462 change, its morphology will change. For example, in an embodiment with a main channel 130 expansion section and a fluid acceleration structure 460, where the main channel 130 expansion section is positioned close to the outlet of the fluid acceleration structure 460, the expansion section can also achieve a certain working effect similar to the expansion section 462.

[0079] In conjunction with the above embodiments, this application provides an atomized drug delivery system, comprising:

[0080] 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;

[0081] The interventional catheter, using the interventional catheter in the above technical solution, has its proximal end connected to the perfusion device for receiving gaseous fluid and liquid fluid respectively;

[0082] A sampling device used to collect the state parameters of a fluid;

[0083] The control device, connected to the acquisition device, is used to receive status parameters and control the injection device accordingly.

[0084] In conjunction with the device described below, this application can also be understood as disclosing a gas-liquid two-phase interventional device, wherein the interventional device includes:

[0085] The housing has gas and liquid connectors installed on it. A pump chamber is located at the bottom inside the housing. The operation panel 800 is located on the outside of the housing 500 and is used to input control information and output parameter status.

[0086] The air pump is installed in the pump room. Multiple air pumps are connected in parallel and connected to the air circuit connector through a main pipe.

[0087] Cooling components, thermally coupled to the air pump;

[0088] 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.

[0089] The drive mechanism is linked to the piston of the syringe;

[0090] The interventional catheter, using the interventional catheter in the above technical solution, has its proximal end connected to the gas circuit connector and the liquid circuit connector, respectively, for receiving gaseous fluid and liquid fluid.

[0091] For specific equipment settings, please refer to the appendix. Figure 3 To be continued Figure 6 In the illustrated embodiments, this application also discloses an interventional device, wherein the interventional device includes:

[0092] The housing 500 is equipped with a gas connection 501 and a liquid connection 502. A pump chamber 510 is located at the bottom inside the housing 500.

[0093] 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.

[0094] Cooling assembly 530 is thermally coupled to air pump 520;

[0095] The syringe 600 includes a barrel installed within a housing 500 and a piston slidably mounted within the barrel. The barrel has an outlet and communicates with a fluid connector 502.

[0096] The drive mechanism 700 is linked to the piston of the syringe 600.

[0097] The gas-liquid two-phase interventional device in this application can be divided into a gas path section and a liquid path section, which enter the interventional catheter through the gas path connector 501 and the liquid path connector 502, respectively.

[0098] Referring to one embodiment of the gas path structure, the intervention device includes:

[0099] 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.

[0100] 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.

[0101] 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;

[0102] Cooling fan 531 is thermally coupled to air pump 520.

[0103] In this embodiment, an air pump 520 is used to provide the air source, thereby realizing the function of the air circuit. In actual use, the inventors found that medical pneumatic equipment needs to meet the requirement of being oil-free, which leads to dry friction of the pump body inside the air pump 520, resulting in relatively serious heat generation and affecting its lifespan. At the same time, in order to reduce noise, a shield is generally used, but this setting will lead to the inability to form an effective air duct or the air outlet being too small, causing temperature rise. In addition, under certain special high pressure requirements of consumable instruments, the air pump 520 has excessive temperature rise and excessive load; the combination of these two factors leads to excessive heat generation after long-term operation, affecting the output air pressure of the air pump 520 or significantly affecting the lifespan of the instrument. In order to overcome the above problems, this application has optimized heat dissipation. Referring to the embodiment shown in the accompanying drawings, the cooling fan 531 is located outside the pump chamber 510, and the side wall of the pump chamber 510 has a heat dissipation window 532 through which the cooling airflow of the cooling fan 531 passes. Inside the pump chamber 510, there is a heat exchange component 533 thermally coupled to the air pump 520, and at least a part of the heat exchange component 533 is aligned with the heat dissipation window 532. In the accompanying drawings, heat exchangers 533 are arranged in groups, with at least two heat exchangers 533 in each 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 can correspond to a different air pump 520 or a different pump head of a single air pump 520. In the accompanying 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 exchangers 533 can be made of a material with high thermal conductivity, or the heat exchange efficiency can be improved by increasing the surface area. Alternatively, referring to the embodiment shown in the accompanying drawings, the heat exchanger 533 is a thermoelectric cooler with its cold end thermally coupled to the pump head of the air pump 520, and its hot end 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 air, and the heat on the thermoelectric cooler is carried away by blowing / suction. Closed-loop control can also be achieved by setting 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 when the temperature is low. This forms a closed loop, controlling the temperature of the air pump 520 within an efficient operating temperature range. If the temperature cannot be lowered and exceeds a preset value, an alarm is triggered or an instruction is given to the system to stop the pump.

[0104] The airflow direction of the cooling fan 531 needs to be adjusted according to the material of the heat exchanger 533.

[0105] For example, when the heat exchanger 533 is made of a material with high thermal conductivity, the cooling fan 531 can be selected to blow air to deliver cold 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 is then discharged through the exhaust port at the bottom of the pump chamber 510.

[0106] In this embodiment, the pressure relief duct 5122 receives the gas flowing from the four-way interface 5123 and enters the pump chamber 510, forming a positive pressure in the pump chamber 510. The cooling fan 531 assists in the airflow by drawing air out.

[0107] 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:

[0108] The dual pumps operate at low pressure simultaneously to provide the final output high pressure: Since the parameters of the consumables (interventional catheter) 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 operation 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 rear end and sent to the main pipe 511 to generate the working pressure requirement, which greatly reduces the utilization factor of each unit.

[0109] Dual pumps working separately extend service life: When the working pressure is low, one air pump is used for each operation, which 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.

[0110] 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 4 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 fiber 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). A first filter 5211 is provided on the air inlet pipe.

[0111] In addition, the above problems can be overcome by installing shock absorption devices. (See attached reference) Figure 5 In the illustrated embodiment, the air pump 520 is connected to the housing 500 via a secondary vibration damping device 514, which includes:

[0112] Several first buffer blocks 5141 are disposed on the housing 500;

[0113] The primary shock absorption platform 5142 is supported by each first buffer block 5141;

[0114] Several second buffer blocks 5143 are set on the primary shock absorption platform 5142 and connected to the air pump 520.

[0115] The second buffer block 5143 has a lower hardness than the first buffer block 5141, effectively blocking vibration transmission between the air pump 520 and the housing 500. Structurally, the second buffer block 5143 is a thin-walled cylindrical structure with first and second mounting slots 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 distance between the first and second mounting slots is approximately 8 mm, and the wall thickness of the cylindrical portion between the first and second mounting slots is approximately 1 mm. Overall, 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 vibration.

[0116] 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.

[0117] 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.

[0118] In addition to structural optimization, optimization can also be achieved through control methods. For example, this application also discloses an interventional device control method, which specifically includes:

[0119] S1, preset target air pressure and at least two sets of PID parameters, and associate each target air pressure with the corresponding PID parameters;

[0120] S2, the infusion device first provides gaseous fluid to the interventional catheter;

[0121] S3, the sampling device collects the first real-time air pressure value, compares the first real-time air pressure value with the target air pressure, the control device retrieves the corresponding PID parameters, and uses the PID parameters to adjust the gas phase fluid pressure value of the infusion device;

[0122] S4, the perfusion device then provides liquid fluid to the interventional catheter so that the interventional catheter outputs atomized fluid;

[0123] S5, the sampling device collects the second real-time air pressure value, compares the second real-time air pressure value with the target air pressure, the control device retrieves the corresponding PID parameters, and uses the PID parameters to adjust the gas phase fluid pressure value of the infusion device;

[0124] S6, repeat step S5 at preset intervals.

[0125] By controlling the interventional system's operation using at least two sets of PID parameters, operational stability can be effectively improved. For example, if the target pressure is a target pressure value, the control device determines the relationship between the second real-time pressure value and the target pressure value to select the necessary PID parameters. Alternatively, if the target pressure is a target pressure range, the control device determines the target pressure range within which the second real-time pressure value falls to select the necessary PID parameters. In detail, using corresponding PID parameters to adjust the gas phase fluid pressure of the perfusion device can prevent liquid phase fluid from entering the gas path of the interventional catheter, thus improving safety.

[0126] Furthermore, the first real-time air pressure value is less than the second real-time air pressure value. This setting prevents excessively high air pressure from cutting off the fluid path within the interventional catheter. At least two voltage values ​​are preset, with each set of PID parameters associated with a corresponding voltage value. When the control device retrieves the corresponding PID parameter, it adjusts the starting voltage value of the infusion device based on the voltage value corresponding to that PID parameter. This setting can shorten the start-up time of the air pump.

[0127] In other embodiments, the intervention system control method further includes:

[0128] S7, the perfusion device first stops supplying liquid fluid to the interventional catheter, and then stops supplying gaseous fluid to the interventional catheter. This step is mainly used to clear the liquid fluid inside the interventional catheter.

[0129] This embodiment provides a method for segmented adjustment of gas phase fluid pressure: the target pressure of the gas phase fluid is divided into at least two segments, and each segment is adjusted using independent PID control parameters. Control parameters may include, for example, an initial voltage value.

[0130] In this embodiment, the threshold values ​​for each segment are preset in the control unit, for example, 120 kPa or 130 kPa. By dividing the PID control parameters into multiple segments, stable and rapid pressure regulation with small overshoot can be achieved in each segment, resulting in stable atomization with minimal fluctuations and more precise control. For example, the target gaseous fluid pressure can be divided into a low-pressure segment of 50 kPa to 130 kPa and a high-pressure segment of 130 kPa to 200 kPa. The range of adjustment for each PID control segment is typically between 20 and 80 kPa. Based on the segmented PID control strategy (i.e., the method described above for regulating gaseous fluid pressure), the interventional catheter needs to deliver liquid fluid first, followed by gaseous fluid, to facilitate accurate sampling by the pressure sensor.

[0131] The interventional device includes a display unit, which may also be equipped with a touch function for human-machine interaction with the control unit located within the control panel. During use, the user inputs the target pressure range via the display unit, for example, 70 kPa to 200 kPa, and then activates the interventional device via the control unit.

[0132] 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.

[0133] 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. An interventional catheter, characterized in that, The tube includes a proximal end and a distal end that extends into the bronchus. The tube contains a microfluidic chip, which has the following characteristics: The first fluid inlet is located on the proximal side of the microchannel chip; There are two second fluid inlets, which are distributed on two opposite sides of the microchannel chip. The outlet is located on the distal side of the microfluidic chip; The interior of the microchannel chip is a chip flow channel connecting the outlet and each fluid inlet, and the chip flow channel includes: The main channel is connected to the first fluid inlet at one end and to the outlet at the other end; A side channel, one end connected to the second fluid inlet and the other end connected to the main channel, has multiple spaced distribution components inside. There are two side channels, symmetrically distributed on both sides of the main channel. Each side channel is connected to the middle and lower reaches of the main channel. The side channel has a turning point pointing to the distal end at the second fluid inlet. At the end of the turning point and on the side facing the main channel, it is connected to the main channel through a confluence section. The distribution components are arranged sequentially along the length of the main channel in the confluence section. The confluence section includes multiple narrowing sections in sequence, and the distribution components are located between adjacent stages.

2. The interventional catheter according to claim 1, characterized in that, The main channel is provided with a fluid acceleration structure and a sudden expansion section arranged sequentially according to the fluid flow direction, wherein the confluence section is connected to the sudden expansion section, and the connection part is adjacent to the fluid acceleration structure.

3. The interventional catheter according to claim 1, characterized in that, The narrowing section comprises three levels, with the distribution component located between the first two levels.

4. The interventional catheter according to claim 3, characterized in that, The overall extension direction of the intersection section is along the width direction of the main channel. Each narrowing section has two opposing sidewalls, and at least one sidewall is arranged at an angle relative to the extension direction so that the narrowing section gradually narrows.

5. The interventional catheter according to claim 4, characterized in that, Of the two sidewalls, one is parallel to the extending direction, and the other is arranged at an angle.

6. The interventional catheter according to claim 5, characterized in that, In the two downstream stages, the inclined sidewalls are located on opposite sides of the flow channel.

7. The interventional catheter according to claim 4, characterized in that, After each narrowing stage, the flow channel width changes by 20-60%.

8. The interventional catheter according to claim 1, characterized in that, The distribution components are toothed in shape, and the cross-sectional dimensions of each distribution component gradually increase in the direction of fluid flow.

9. The interventional catheter according to claim 8, characterized in that, Downstream of the distributor, the distributor occupies 30-70% of the width of the flow channel.

10. A nebulized drug delivery system, characterized in that, include: 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; An interventional catheter, comprising the interventional catheter according to any one of claims 1 to 9, wherein the proximal end of the interventional catheter is connected to an infusion device for receiving gaseous fluid and liquid fluid respectively; A sampling device used to collect the state parameters of a fluid; The control device, connected to the acquisition device, is used to receive status parameters and control the injection device accordingly.

11. A gas-liquid two-phase intervention device, characterized in that, include: The housing is equipped with air and liquid connectors, and a pump chamber is located at the bottom inside the housing. The air pump is installed in the pump room. Multiple air pumps are connected in parallel and connected to the air circuit connector through a main pipe. Cooling components, thermally coupled to the air pump; 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; An interventional catheter, wherein the proximal end of the interventional catheter is connected to the gas connector and the liquid connector respectively, for receiving gaseous fluid and liquid fluid respectively.

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