Abdominal cavity atomization drug delivery instrument and sterile protection operation sleeve

Abstract

The invention discloses an abdominal cavity atomization drug delivery instrument and a sterile protection operation sleeve, and relates to the technical field of medical instruments, the abdominal cavity atomization drug delivery instrument comprises a high pressure generation unit, a power unit, a transmission unit, a negative pressure unit, a temperature pressure unit and a central control module; wherein the power unit drives a piston of the high-pressure generating unit through the transmission unit to generate ultrahigh pressure on liquid medicine, so that the liquid medicine is conveyed to the atomizing end through the high-pressure-resistant pipeline, is atomized into superfine particles and is sprayed to the diseased region of the abdominal cavity in a targeted manner; the temperature and pressure unit adopts PWM (Pulse Width Modulation) control and SPI (Serial Peripheral Interface) sensing technologies to realize accurate heating power and pressure control of liquid medicine and abdominal cavity gas; the negative pressure unit synchronously sucks the aerosol, and the aerosol is harmlessly discharged after being efficiently filtered; the central control module dynamically optimizes the atomization particle size and the temperature and pressure of the liquid medicine and the abdominal cavity through multi-parameter closed-loop regulation and control, so that the medicine penetration depth and heating treatment generate a synergistic effect, the permeability, penetration depth and curative effect of liquid medicine particles are improved, the treatment time is shortened, and side effects are reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to an abdominal cavity atomizing drug delivery device and a sterile protection operation sleeve. Background Art

[0002] In recent years, the treatment methods for abdominal diseases have been continuously developing. The local drug delivery technology in the abdominal cavity is an important means for treating diseases such as abdominal tumors, postoperative infections, and peritoneal metastases. Among them, the drug atomization and penetration treatment has become one of the important means of local drug delivery technology in the abdominal cavity.

[0003] Traditional drug delivery methods mostly rely on intravenous injection or peritoneal perfusion, but there are problems such as uneven drug distribution, insufficient local concentration, limited penetration effect, low treatment efficiency, and obvious systemic side effects. In recent years, with the development of minimally invasive medicine, the atomizing drug delivery technology has gradually attracted attention due to its advantages of achieving targeted drug delivery and increasing local drug concentration. In the prior art, some atomizing devices have been tried to be applied to abdominal cavity treatment. For example, an atomizing nozzle is placed into the abdominal cavity through a laparoscope channel, and the liquid medicine is atomized and sprayed by using air pressure drive. However, such technologies still have significant limitations in practical applications.

[0004] How to improve the coverage rate and permeability of drugs at the lesion site during the treatment process to improve the treatment effect has become an important direction of current medical research and technological development.

[0005] Currently, most foreign abdominal cavity atomizing devices are based on conventional air pressure atomization principles (such as the Venturi effect or ultrasonic atomization). Their atomization pressure is usually lower than 2 - 2.5 MPa, and the diameter of the liquid medicine particles produced is mostly distributed in the range of 50 - 200 μm. However, research shows that drug particles need to reach below 10 μm to effectively penetrate the peritoneal mesothelial cell layer, and the atomization particle size of the existing devices is difficult to meet the treatment penetration requirements.

[0006] In addition, the atomization field covered by the traditional atomizing nozzle in a low - pressure environment has a limited range, which easily leads to incomplete drug coverage in the lesion area. Some existing technologies try to improve the atomization uniformity by improving the nozzle hole structure (such as a multi - hole dispersion nozzle), but there are still problems such as atomization particle agglomeration and fast deposition speed of liquid medicine particles in the complex internal structure environment of the abdominal cavity.

[0007] In particular, the prior art lacks the collaborative design of heating drug delivery and high - pressure atomization, and it is difficult to maximize the utilization of the drug thermodynamics effect.

[0008] In terms of equipment reliability, existing devices generally face the technical bottleneck of insufficient high - pressure sealing performance. When the atomization pressure exceeds 5 MPa, the conventional atomization cavity is prone to liquid medicine leakage, and the nozzle is prone to structural deformation or being blocked by liquid medicine particles during long - term high - pressure operation.

[0009] In the prior art, the abdominal atomization device disclosed, although its atomizing nozzle is made of titanium alloy material to improve the pressure resistance, its atomization efficiency and particle size control still fail to break through the technical bottleneck.

[0010] Therefore, the defects of the prior art are as follows: insufficient control of the atomization particle size, the diameter of the liquid medicine particles generated by the conventional atomization device is too large (>50μm), making it difficult to penetrate the peritoneal tissue to reach the effective treatment concentration; poor targeted coverage ability, the existing nozzle design cannot form a uniform atomization field in the complex abdominal cavity, resulting in uneven drug distribution in the lesion area; lack of thermal force coordination, the lack of a collaborative structural design of the heating drug delivery system and high-pressure atomization fails to fully utilize the synergistic effect of hyperthermia to enhance drug penetration; high-pressure stability defect, the atomization system has a risk of seal failure or nozzle blockage under high-pressure working conditions, restricting the atomization efficiency and equipment reliability.

[0011] To sum up, it is found that the prior art has at least the following technical problems: The existing liquid medicine atomization device for abdominal drug delivery has technical problems such as large atomization particle size, low atomization uniformity, lack of thermal force coordination, and low high-pressure stability, resulting in difficulty in meeting the treatment penetration requirements in the abdomen. Summary of the Invention

[0012] The purpose of the present invention is to provide an abdominal atomization drug delivery instrument and a sterile protection operation sleeve to solve the technical problems of the existing liquid medicine atomization device for abdominal drug delivery, such as large atomization particle size, low atomization uniformity, lack of thermal force coordination, and low high-pressure stability.

[0013] The many technical effects that can be produced by the preferred technical solutions provided by the present invention are described in detail below.

[0014] To solve the above technical problems, the present invention provides the following technical solutions: The present invention provides an abdominal cavity atomization drug delivery device, which includes a high-pressure generating unit. The atomization end of the high-pressure generating unit extends into the abdominal cavity to be treated for atomizing and spraying the loaded liquid medicine on the affected area. And a power unit and a transmission unit. The power unit drives the transmission unit in rotation. The transmission unit converts the rotation into movement and pushes the piston in the high-pressure generating unit to apply ultra-high pressure to the liquid medicine, so that the liquid medicine reaches the atomization end with power. After the atomization end atomizes the liquid medicine, the liquid medicine is ejected in the form of extremely fine mist particles. And a negative pressure unit. The negative pressure end of the negative pressure unit extends into the abdominal cavity to suck out the generated abdominal cavity aerosol and filter it for harmless treatment. And a temperature and pressure unit. The temperature and pressure unit is provided with a plurality of heating devices and sensors, and controls the heating devices to heat the liquid medicine and the abdominal cavity gas through PWM, and interprets the sensors through SPI to obtain the liquid medicine temperature, the abdominal cavity gas temperature and the abdominal cavity gas pressure. And a central control module. The central control module receives the set data of the operator as the operation index, and electrically connects and controls the power unit, the transmission unit, the negative pressure unit and the temperature and pressure unit to cooperate with each other, perform information interaction to form a closed-loop control, and complete the coordinated action control of the atomization degree of the liquid medicine, the liquid medicine temperature, the liquid medicine injection amount, the abdominal cavity gas temperature, the abdominal cavity gas pressure and the exhaust purification, so as to realize high-pressure atomization heating drug delivery treatment in the abdominal cavity.

[0015] In one embodiment, the high-pressure generating unit includes an explosion-proof syringe, a liquid pipe and an atomizing nozzle, and the liquid pipe is a high-pressure resistant pipe. The explosion-proof syringe is loaded with the liquid medicine for drug delivery treatment. Two ends of the liquid pipe are respectively connected with the liquid outlet end of the explosion-proof syringe and the liquid inlet end of the atomizing nozzle. The atomization end is arranged on the atomizing nozzle. The piston is arranged in the explosion-proof syringe. One end of the piston contacts the liquid medicine, and the other end is connected with the moving end of the transmission unit.

[0016] In one embodiment, the particle size of the mist particles atomized and ejected by the atomizing nozzle is less than or equal to 10 μm, and the ultra-high pressure is 5-9 MPa.

[0017] In one embodiment, the barrel of the explosion-proof syringe is a thickened disposable barrel.

[0018] In one embodiment, the barrel of the explosion-proof syringe is made of a material resistant to high pressure and corrosion.

[0019] In one embodiment, the explosion-proof syringe includes a barrel, an explosion-proof shell, and the piston; the explosion-proof shell is sleeved outside the barrel, one end of the explosion-proof shell is hermetically connected to the outer wall of the liquid outlet end of the barrel, and a hole for the liquid outlet end to extend out is provided; the other end of the explosion-proof shell is provided with an openable and closable sealing member; the sealing member is used for replacing the barrel when opened, and for allowing the moving end of the transmission unit to pass through and sealing the outer wall of the moving end when closed.

[0020] In one embodiment, the transmission unit includes a transmission lead screw and a transmission nut, the output end of the power unit is in transmission connection with the transmission lead screw or the transmission nut, the power unit transmits the output rotation to the transmission lead screw or the transmission nut, and the transmission lead screw or the transmission nut converts the rotation into displacement and transmits it to the piston.

[0021] In one embodiment, when the transmission lead screw receives the rotation of the power unit, the transmission nut moves linearly along the axis of the transmission lead screw, and the transmission nut transmits the displacement to the piston; the transmission unit is further provided with a guide rod, and the guide rod is slidably connected to the transmission nut; a push rod is further provided between the transmission nut and the piston, the push rod connects the transmission nut and the piston, and the piston and the push rod are detachably separable.

[0022] In one embodiment, when the transmission nut receives the rotation of the power unit, the transmission lead screw moves linearly along the axis of the transmission nut, and the transmission lead screw transmits the displacement to the piston; the transmission unit is provided with a rotating base, the transmission nut is rotatably installed on the rotating base, the power unit is rotatably connected to the transmission nut to drive the transmission nut to rotate; the transmission lead screw passes through the central screw hole of the transmission nut, and the transmission nut drives the transmission lead screw to move.

[0023] In one embodiment, the power unit includes a servo motor and a servo driver, the output end of the servo motor is connected to the input end of the transmission unit, and the transmission unit receives the rotation of the servo motor; the servo driver is electrically connected to the servo motor, and the servo driver is electrically connected to the central control module to receive the data of the central control module controlling the piston to start displacement, stop displacement, and the distance and speed of displacement.

[0024] In one embodiment, the negative pressure unit includes a suction component, a filtering component, and a suction pipe; the suction pipe is used to extend into the abdominal cavity and suck out abdominal cavity aerosol with the negative pressure generated by the suction component, and the sucked abdominal cavity aerosol is filtered and purified by the filtering component and then discharged.

[0025] In one embodiment, the suction component is connected to the air outlet end of the filtering component through a pipeline, and the suction pipe is connected to the air inlet end of the filtering component; a purification liquid is contained in the filtering component. By introducing the abdominal cavity aerosol inhaled through the suction pipe into the purification liquid, after the pollutants in the abdominal cavity aerosol are absorbed by the purification liquid, a purified gas is released. After the purified gas enters the suction component through the air outlet end of the filtering component, it is discharged through the suction component.

[0026] In one embodiment, the suction pipe is connected to the negative pressure end of the suction component, and the exhaust end of the suction component is connected to the filtering component through a pipeline. The suction component introduces the sucked abdominal cavity aerosol into the air inlet end of the filtering component; a purification liquid is contained in the filtering component. The abdominal cavity aerosol is introduced into the purification liquid, and after the pollutants in the abdominal cavity aerosol are absorbed by the purification liquid, a purified gas is released. The purified gas is discharged through the air outlet end of the filtering component.

[0027] In one embodiment, a liquid mass sensor is arranged in the purification liquid of the filtering component. The liquid mass sensor is electrically connected to the central control module and is used for monitoring the pollution degree of the purification liquid, outputting the pollution data of the purification liquid to the central control module, and the central control module judges the pollution degree or cleanliness of the purification liquid through a built-in algorithm.

[0028] In one embodiment, a gas mass sensor is arranged inside or outside the air outlet end of the filtering component on the path of discharging the purified gas and is used for monitoring the pollution degree of the purified gas, outputting the pollution data of the purified gas to the central control module, and the central control module judges the pollution degree or cleanliness of the purified gas through a built-in algorithm.

[0029] In one embodiment, the temperature and pressure unit includes a liquid medicine heater, a first temperature sensor, and a second temperature sensor that are electrically connected to the central control module; the liquid medicine heater is disposed on the high-pressure generating unit and heats the liquid medicine loaded in the high-pressure generating unit to reach the preset temperature of the central control module; the first temperature sensor is used to monitor the real-time temperature of the liquid medicine, and the second temperature sensor is used to monitor the output temperature of the liquid medicine heater, and transmits the real-time temperature of the liquid medicine and the output temperature data of the liquid medicine heater to the central control module, and the central control module performs closed-loop control on the real-time temperature of the liquid medicine and the liquid medicine heater; and an abdominal cavity heater, a third temperature sensor, and a fourth temperature sensor that are electrically connected to the central control module; the abdominal cavity heater is disposed on the abdomen and is used to heat the abdomen and conduct heat to the abdominal cavity gas in the abdominal cavity to raise the temperature of the abdominal cavity gas to the preset temperature of the central control module; the third temperature sensor is used to monitor the real-time temperature of the abdominal cavity gas, and the fourth temperature sensor is used to monitor the output temperature of the abdominal cavity heater, and transmits the real-time temperature of the abdominal cavity gas and the output temperature data of the abdominal cavity heater to the central control module, and the central control module performs closed-loop control on the real-time temperature of the abdominal cavity gas and the abdominal cavity heater; and an abdominal cavity pressure sensor that is electrically connected to the central control module, and the abdominal cavity pressure sensor is used to monitor the abdominal cavity air pressure and transmits the abdominal cavity air pressure data to the central control module, and the central control module jointly controls the pressure and flow rate of the atomized liquid medicine ejected by the high-pressure generating unit and controls the pressure and flow rate of the abdominal cavity aerosol sucked out by the negative pressure unit in cooperation with the power unit to jointly control the abdominal cavity air pressure in a closed-loop control manner.

[0030] In one embodiment, a limit module, a position detection module, and a liquid medicine pressure module that are electrically connected to the central control module are installed on the high-pressure generating unit and perform data interaction; the limit module is used to obtain the starting position and the final position of the piston and feedback the starting position and the final position data of the piston to the central control module; the position detection module is used to obtain the current position of the piston, feedback the current position data of the piston to the central control module, and calculate the current liquid medicine injection amount through the built-in algorithm of the central control module; the liquid medicine pressure module is used to detect the current pressure of the liquid medicine in the high-pressure generating unit and feedback the current pressure data of the liquid medicine to the central control module.

[0031] In one embodiment, a rotation sensor is installed on the power unit and is used to detect the number of rotation turns and the rotation speed output by the power unit and feedback the number of rotation turns and the rotation speed data output by the power unit to the central control module.

[0032] In one embodiment, the central control module controls the atomization degree and injection volume of the liquid medicine in a closed-loop control manner by obtaining the starting position, final position and current position of the piston, obtaining the current pressure data of the liquid medicine in the high-pressure generating unit, and obtaining the number of rotation turns and rotation speed data output by the power unit, and coordinates the power unit, the transmission unit and the high-pressure generating unit.

[0033] The present invention also provides a sterile protection operation sleeve, which includes a sterile operation sleeve and the above-mentioned peritoneal cavity atomization drug delivery instrument. The sterile operation sleeve is sleeved on the abdominal wound to isolate the peritoneal cavity wound from the external environment and form a sterile environment in the sterile operation sleeve for the atomization end to extend into the peritoneal cavity to be treated in a sterile manner for high-pressure atomization heating drug delivery treatment.

[0034] The present invention also provides a PC-side processor, which includes a PC processing unit and the above-mentioned peritoneal cavity atomization drug delivery instrument. The PC processing unit is electrically connected to the central control module for data interaction, and is used for receiving the drug delivery data set by the user and converting it into interaction data to be transmitted to the central control module.

[0035] The present invention also provides an interactor, which includes an operation screen and the above-mentioned PC-side processor. The operation screen is electrically connected to the PC processing unit for data interaction, and is used for the user to set a drug delivery instruction and convert it into an interaction instruction to be transmitted to the PC processing unit.

[0036] Advantages of the present invention: The present invention provides an intraperitoneal atomizing drug delivery device and a sterile protection operation sleeve. The intraperitoneal atomizing drug delivery device includes a high-pressure generating unit, the atomizing end of the high-pressure generating unit extends into the intraperitoneal cavity to be treated for atomizing the loaded liquid medicine and spraying it on the affected area; a power unit and a transmission unit, the power unit drives the transmission unit by rotation, the transmission unit converts the rotation into movement and pushes the piston in the high-pressure generating unit to apply ultra-high pressure to the liquid medicine, so that the liquid medicine reaches the atomizing end with power, and after the atomizing end atomizes the liquid medicine, the liquid medicine is ejected in the form of extremely fine mist particles; a negative pressure unit, the negative pressure end of the negative pressure unit extends into the intraperitoneal cavity to suck out the generated intraperitoneal aerosol and filter it for harmless treatment; a temperature and pressure unit, the temperature and pressure unit is provided with a plurality of heating devices and sensors, and controls the heating devices to heat the liquid medicine and the intraperitoneal gas through PWM, and interprets the sensors through SPI to obtain the liquid medicine temperature, the intraperitoneal gas temperature and the intraperitoneal gas pressure; and a central control module, the central control module receives the set data of the operator as the operation index, and electrically connects and controls the power unit, the transmission unit, the negative pressure unit and the temperature and pressure unit to cooperate with each other, perform information interaction to form a closed-loop control, and complete the coordinated action control of the atomization degree of the liquid medicine, the liquid medicine temperature, the liquid medicine injection volume, the intraperitoneal gas temperature, the intraperitoneal gas pressure and the exhaust purification, so as to realize high-pressure atomizing heating drug delivery treatment in the intraperitoneal cavity. A sterile protection operation sleeve provided by an embodiment of the present invention includes a sterile operation sleeve and the above-mentioned intraperitoneal atomizing drug delivery device. The sterile operation sleeve is sleeved on the abdominal wound to isolate the intraperitoneal wound from the external environment and form a sterile environment in the sterile operation sleeve for the atomizing end to extend into the intraperitoneal cavity to be treated in a sterile manner for high-pressure atomizing heating drug delivery treatment.

[0037] Aiming at the core problems existing in the existing intraperitoneal atomizing drug delivery device, such as large atomization particle size, poor targeting, lack of thermal cooperation and insufficient high-pressure stability, through the ultra-high pressure atomization technology, heating drug delivery cooperative control and intelligent closed-loop system design used in the above technical solutions, the liquid medicine is atomized into extremely fine particles, and in the form of atomizing spray, the liquid medicine is evenly distributed at the diseased site in the intraperitoneal cavity, improving the drug penetration effect, thereby enhancing the treatment accuracy and efficacy and reducing side effects.

[0038] Specifically, its remarkable technical advantages and clinical application values are as follows: (1) Break through the drug penetration bottleneck through ultra-high pressure atomization technology Under the action of the high-pressure generating unit that pressurizes the liquid medicine to an ultra-high pressure of 5-9 MPa, the liquid medicine required for treatment is atomized into small enough liquid medicine particles through the atomizing end; using the particle penetration principle, the liquid medicine atomized into small enough particles is sent to the lesion site, allowing the liquid medicine of the drug to come into full contact with the abdominal cavity lesion site, thereby achieving the effects of improving the curative effect and reducing the treatment side effects. Compared with traditional chemotherapy, the drug side effects are reduced by 90%, and it has the advantages of quick effect, small side effects, and greatly shortened treatment time.

[0039] Through the precise cooperation of the power unit and the transmission unit, combined with the high-pressure-resistant atomizing nozzle that can be set at the atomizing end, the diameter of the atomized liquid medicine particles is accurately controlled within an extremely fine range of 5-10 μm.

[0040] Experimental data show that the liquid medicine particles atomized into a diameter range of 5-10 μm can penetrate the peritoneal mesothelial cell layer, improve the drug penetration depth and penetration rate, and significantly increase the effective drug concentration at the lesion site.

[0041] At the same time, the real-time feedback of the pressure from the temperature and pressure unit to the central control module ensures the stability and reliability of the liquid medicine atomization process, avoiding the agglomeration of liquid medicine particles or the blockage of the atomizing nozzle at the atomizing end caused by sudden pressure changes.

[0042] (2)Enhance the treatment targeting through thermo-mechanical synergy Integrate the closed-loop control algorithm of the temperature and pressure unit and the central control module to achieve the synergistic effect of liquid medicine heating and abdominal cavity gas heating; in the heated drug delivery environment, the diffusion coefficient of the atomized liquid medicine particles is increased by 1.8-2.3 times. At the same time, high temperature induces an increase in the permeability of the tumor cell membrane, which helps the drug reach the lesion directly, increases the effect of the drug, improves the targeting of drug treatment, and realizes precise drug delivery and precise treatment.

[0043] Collect the pressure data and temperature data of the abdominal cavity gas collected by the sensor in real time through the SPI bus to ensure that the environment for heating and atomizing the drug for treatment meets the optimal window of thermodynamics, and control the error of the temperature of the atomized liquid medicine particles reaching the abdominal cavity and the temperature of the abdominal cavity gas within the range of ±0.5 °C to avoid the risk of thermal injury.

[0044] (3)Improve the reliability of the abdominal cavity atomizing drug delivery device through intelligent closed-loop control The central control module realizes dynamic regulation through multi-modal signal fusion: Adaptive compensation of liquid medicine pressure: When the atomizing resistance at the atomizing end suddenly changes, the power unit cooperates with the transmission unit to automatically adjust the injection speed of the liquid medicine to maintain a constant liquid medicine atomization pressure; Thermal equilibrium mechanism: The central control module dynamically adjusts the heating power of the heating device for heating the liquid medicine and the heating device for heating the abdominal cavity gas according to the feedback of the temperature data of the abdominal cavity gas, avoiding local overheating of the abdominal cavity gas; Purification linkage of abdominal cavity aerosol: The negative pressure unit starts and stops synchronously and is regulated with the injection of liquid medicine particles at the atomization end of the high-pressure generating unit, ensuring that the residual amount of abdominal cavity aerosol is controlled within 0.1 μg / m³, greatly reducing the risks of abdominal cavity infection and drug side effects.

[0045] (4) Enhancing the treatment advantages of the abdominal cavity atomization drug delivery device through multi-dimensional coordination Through the coordination of the power unit, the transmission unit, the high-pressure generating unit, the negative pressure unit and the temperature and pressure unit, the triple coordination effect of ultra-high pressure atomization, heated atomization drug delivery and closed-loop control of temperature and pressure is achieved. When performing abdominal cavity atomization drug delivery, after improving the drug efficacy, it can achieve the effects of increasing the tumor inhibition rate, significantly reducing side effects and shortening the treatment cycle.

[0046] (5) The abdominal cavity atomization drug delivery device has high drug compatibility and scalability for administration Modular design: The atomization end can be adapted to atomizing nozzles with different apertures, and the atomization end can spray liquid medicine particles with different particle sizes according to different treatment plans, meeting the diverse requirements of heated high-pressure atomization drug delivery in the abdominal cavity from chemotherapy drugs to biological agents.

[0047] Data interconnection: The central control module collects the treatment parameters of atomization drug delivery in the abdominal cavity, retains the treatment data for subsequent use, and even stores it in the cloud. It conducts AI-assisted analysis of the drug delivery power, pharmacology and efficacy of the treatment plan, providing data support for formulating personalized atomization drug delivery treatment plans in the abdominal cavity according to different conditions in the future, so as to be able to give a better treatment plan, maximize the drug effect of the treatment and relieve the pain of patients.

[0048] In summary, the present invention realizes the control of ultra-high pressure atomization particle size through the power unit, the transmission unit and the high-voltage generation unit, realizes the thermal synergistic enhancement of drug penetration through the temperature and pressure unit and the negative pressure unit, and the central control module collects the data of the sensors and conducts intelligent closed-loop regulation and multi-unit integrated structure, reducing the particle size of the liquid medicine atomization particles, spraying the liquid medicine atomization particles on the diseased part in the abdominal cavity and evenly distributing them, improving the drug penetration depth and penetration rate, thereby improving the accuracy and curative effect of intra-abdominal atomization drug delivery, reducing the side effects of intra-abdominal drug delivery, solving the technical problems of large atomization particle size, low atomization uniformity, lack of thermal synergy and low high-voltage stability existing in the existing liquid medicine atomization device for intra-abdominal drug delivery, and providing an efficient, accurate and safe intra-abdominal high-pressure atomization drug delivery technical solution for the local treatment of abdominal tumors and peritoneal diseases; moreover, the technical indicators of the intra-abdominal atomization drug delivery instrument of the present invention have reached the international leading level and have significant clinical application value. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] In order to more clearly illustrate the technical solutions of the present invention, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present invention, and those of ordinary skill in the art can also obtain other drawings based on these drawings without creative efforts.

[0050] Figure 1 is one of the schematic diagrams of the control principle of the intra-abdominal atomization drug delivery instrument of the present invention; Figure 2 is the second schematic diagram of the control principle of the intra-abdominal atomization drug delivery instrument of the present invention; Figure 3 is the third schematic diagram of the control principle of the intra-abdominal atomization drug delivery instrument of the present invention; Figure 4 is the fourth schematic diagram of the control principle of the intra-abdominal atomization drug delivery instrument of the present invention; Figure 5 is the fifth schematic diagram of the control principle of the intra-abdominal atomization drug delivery instrument of the present invention; Figure 6 is the sixth schematic diagram of the control principle of the intra-abdominal atomization drug delivery instrument of the present invention; Figure 7 is the seventh schematic diagram of the control principle of the intra-abdominal atomization drug delivery instrument of the present invention; Figure 8 is the eighth schematic diagram of the control principle of the intra-abdominal atomization drug delivery instrument of the present invention; Figure 9 is the ninth schematic diagram of the control principle of the intra-abdominal atomization drug delivery instrument of the present invention; Figure 10 is the tenth schematic diagram of the control principle of the intra-abdominal atomization drug delivery instrument of the present invention; Figure 11It is a schematic diagram of the control principle of the abdominal cavity atomization drug delivery device and the PC - side processor of the present invention; Figure 12 It is a schematic diagram of the control principle of the interactive device and the PC - side processor of the present invention. Specific embodiments

[0051] To make the above - mentioned objects, features, and advantages of the present invention more obvious and understandable, the present invention will be further described below in conjunction with the drawings and embodiments. However, the exemplary embodiments can be implemented in various forms and should not be construed as limited to the embodiments described herein; on the contrary, these embodiments are provided to make the present invention more comprehensive and complete, and to fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings represent the same or similar structures, so the repeated description of them will be omitted. The words expressing positions and directions described in the present invention are all illustrated by taking the drawings as examples, but can be changed according to needs, and all the changes made are included in the protection scope of the present invention. The drawings of the present invention are only used to indicate the relative position relationship and do not represent the actual proportion.

[0052] The treatment methods for abdominal diseases have been continuously developing in recent years. The local drug delivery technology in the abdominal cavity is an important means for treating diseases such as abdominal tumors, postoperative infections, and peritoneal metastases. Among them, drug atomization penetration therapy has become one of the important means of local drug delivery technology in the abdominal cavity. Traditional drug delivery methods mostly rely on intravenous injection or peritoneal perfusion, but there are problems such as uneven drug distribution, insufficient local concentration, limited penetration effect, low treatment efficiency, and obvious systemic side effects. In recent years, with the development of minimally invasive medicine, atomization drug delivery technology has gradually attracted attention due to its advantages of achieving targeted drug delivery and increasing local drug concentration. In the prior art, some atomization devices have been tried to be applied to abdominal cavity treatment. For example, an atomization nozzle is placed into the abdominal cavity through a laparoscopic channel, and air pressure is used to drive the atomization and spraying of the liquid medicine. However, such technologies still have significant limitations in actual applications. How to improve the coverage rate and permeability of drugs at the lesion site during the treatment process to improve the treatment effect has become an important direction in current medical research and technological development.

[0053] Currently, most foreign abdominal atomization devices are based on the principle of conventional pneumatic atomization. Their atomization pressure is usually lower than 2 - 2.5 MPa, and the diameter of the generated liquid medicine particles is mostly distributed in the range of 50 - 200 μm. However, research shows that drug particles need to be below 10 μm to effectively penetrate the peritoneal mesothelial cell layer, and the atomization particle size of existing devices is difficult to meet the treatment penetration requirements. In addition, the atomization field coverage formed by traditional atomization nozzles in a low-pressure environment is limited, easily resulting in incomplete drug coverage in the lesion area. Some existing technologies attempt to improve the atomization uniformity by modifying the nozzle structure (such as porous dispersion nozzles), but there are still problems such as atomization particle agglomeration and fast deposition speed of liquid medicine particles in the complex internal structure environment of the abdomen. In particular, the existing technologies lack the collaborative design of heating drug administration and high-pressure atomization, making it difficult to maximize the utilization of the thermokinetic effect of drugs. In terms of equipment reliability, existing devices generally face the technical bottleneck of insufficient high-pressure sealing. When the atomization pressure exceeds 5 MPa, conventional atomization cavities are prone to liquid medicine leakage, and the nozzle is prone to structural deformation or being blocked by liquid medicine particles during long-term high-pressure operation. Although the atomization nozzles of the abdominal atomization devices disclosed in the existing technologies use titanium alloy materials to improve the pressure resistance, their atomization efficiency and particle size control still fail to break through the technical bottleneck.

[0054] Therefore, the defects of the existing technologies are as follows: insufficient control of atomization particle size, the diameter of the liquid medicine particles generated by conventional atomization devices is too large to penetrate the peritoneal tissue to reach the effective treatment concentration; poor target coverage ability, the existing nozzle design cannot form a uniform atomization field in the complex abdominal cavity, resulting in uneven drug distribution in the lesion area; lack of thermal collaboration, lack of collaborative structural design of the heating drug administration system and high-pressure atomization, and the synergistic effect of hyperthermia-enhanced drug penetration cannot be fully exerted; high-pressure stability defect, there is a risk of seal failure or nozzle blockage in the atomization system under high-pressure working conditions, restricting the atomization efficiency and equipment reliability.

[0055] In view of this, a peritoneal atomization drug delivery device and a sterile protection operation sleeve are provided in the specific embodiments of the present invention. The peritoneal atomization drug delivery device includes a high-pressure generating unit, a power unit, a transmission unit, a negative pressure unit, a temperature and pressure unit, and a central control module. Among them, the power unit drives the piston of the high-pressure generating unit through the transmission unit to generate an ultra-high pressure of 5-9 MPa on the liquid medicine, so that the liquid medicine is transported to the atomization end through a high-pressure resistant pipeline, atomized into extremely fine particles of 5-10 μm, and targeted to be sprayed onto the peritoneal lesion site. The temperature and pressure unit adopts PWM control and SPI sensing technology to achieve precise thermal and pressure control of the liquid medicine and peritoneal gas. The negative pressure unit synchronously aspirates the aerosol and discharges it harmlessly after high-efficiency filtration. The central control module reduces the fluctuations of pressure and temperature through multi-parameter closed-loop regulation, dynamically optimizes the atomization particle size, and the temperature and pressure of the liquid medicine and the peritoneal cavity, so that the drug penetration depth and the heating treatment produce a synergistic effect, improving the penetration rate and penetration depth of the liquid medicine particles, the curative effect, and shortening the treatment time. Compared with the traditional large-dose intravenous injection treatment of drugs, the side effects on the human body are reduced by 90%, and the targeting of drug penetration is also improved. It effectively solves the technical problems of the existing liquid medicine atomization device for peritoneal drug delivery treatment, such as large atomization particle size, low atomization uniformity, lack of thermal synergy, and low high-pressure stability.

[0056] The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention.

[0057] Figure 1 is one of the schematic diagrams of the control principle of the peritoneal atomization drug delivery device of the present invention; Figure 2 is the second schematic diagram of the control principle of the peritoneal atomization drug delivery device of the present invention.

[0058] The first embodiment of the peritoneal atomization drug delivery device is as Figure 1As shown, it includes a high-voltage generating unit, the atomizing end of which extends into the abdominal cavity to be treated for atomizing and spraying the loaded liquid medicine on the affected area; a power unit and a transmission unit, the power unit drives the transmission unit by rotation, the transmission unit converts the rotation into movement, and pushes the piston in the high-voltage generating unit to apply ultra-high pressure to the liquid medicine, giving the liquid medicine power to reach the atomizing end, so that after the atomizing end atomizes the liquid medicine, the liquid medicine is ejected in the form of extremely fine mist particles; a negative-pressure unit, the negative-pressure end of which extends into the abdominal cavity to suck out the generated abdominal aerosol and filter it for harmless treatment; a temperature and pressure unit, which is provided with a plurality of heating devices and sensors, and controls the heating devices to heat the liquid medicine and the abdominal gas through PWM, and interprets the sensors through SPI to obtain the liquid medicine temperature, abdominal gas temperature and abdominal gas pressure; and a central control module, the central control module receives the set data of the operator as operation indicators, and is electrically connected to control the power unit, transmission unit, negative-pressure unit and temperature and pressure unit to cooperate with each other, perform information interaction to form a closed-loop control, and complete the coordinated action control of the atomization degree of the liquid medicine, liquid medicine temperature, liquid medicine injection volume, abdominal gas temperature, abdominal gas pressure and exhaust purification, so as to realize high-pressure atomization heating drug treatment in the abdominal cavity.

[0059] Among them, in this embodiment, Figure 2 As shown, the temperature and pressure unit is provided with a plurality of heating devices including a liquid medicine heater and an abdominal cavity heater; the sensors include a first temperature sensor, a second temperature sensor, a third temperature sensor, a fourth temperature sensor and an abdominal cavity pressure sensor.

[0060] Regarding the specific structure of the above high-voltage generating unit, the high-voltage generating unit includes an explosion-proof syringe, a liquid pipe and an atomizing nozzle, and the liquid pipe is a high-pressure resistant pipe; the explosion-proof syringe is loaded with liquid medicine for drug treatment, and both ends of the liquid pipe are respectively connected to the liquid outlet end of the explosion-proof syringe and the liquid inlet end of the atomizing nozzle; the atomizing end is arranged on the atomizing nozzle; the piston is arranged in the explosion-proof syringe, one end of the piston contacts the liquid medicine, and the other end is connected to the moving end of the transmission unit.

[0061] During application, both ends of the liquid pipe are respectively connected to the liquid outlet end of the explosion-proof syringe and the liquid inlet end of the atomizing nozzle, and are used to transmit the liquid medicine with increased high pressure in the explosion-proof syringe to the atomizing nozzle.

[0062] Specifically, the particle size of the mist particles atomized and ejected by the atomizing nozzle is less than or equal to 10 μm, so as to realize atomizing the liquid medicine into extremely fine liquid medicine particles and discharging them, improving the penetration effect of the medicine on the affected area in the abdominal cavity, and thus improving the curative effect of the medicine.

[0063] In view of the core problems existing in the existing intraperitoneal atomization drug delivery devices, such as large atomization particle size, poor targeting, lack of thermal synergy, and insufficient high-pressure stability, through the application of the ultra-high pressure atomization technology, heating drug delivery collaborative control, and intelligent closed-loop system design in the above technical solutions, the liquid medicine is atomized into extremely fine particles, and through the atomization injection method, the liquid medicine is evenly distributed at the diseased site in the abdominal cavity, improving the drug penetration effect, thereby enhancing the accuracy and efficacy of treatment and reducing side effects.

[0064] The significant technical advantages and clinical application values achieved are as follows: (1) Break through the drug penetration bottleneck through ultra-high pressure atomization technology Under the action of ultra-high pressure, the liquid medicine required for treatment is atomized into small enough liquid medicine particles through the atomization end; using the particle penetration principle, the liquid medicine atomized into small enough particles is sent to the diseased site, allowing the liquid medicine of the drug to fully contact the diseased site in the abdominal cavity, so as to achieve the effects of improving the curative effect and reducing the side effects of treatment. Compared with traditional chemotherapy, the drug side effects can be reduced by 90%, and it has the advantages of quick effect, small side effects, and greatly shortened treatment time.

[0065] Through the precise cooperation of the power unit and the transmission unit, combined with the high-pressure resistant atomization nozzle that can be set at the atomization end, the diameter of the atomized liquid medicine particles is accurately controlled within the extremely fine range of 5-10μm.

[0066] Among them, through the precise cooperation of the power unit and the transmission unit, the pressurization pressure of the liquid medicine in the high-pressure generating unit can reach the ultra-high pressure range of 5-9MPa, combined with the high-pressure resistant atomization nozzle set at the atomization end, and the compressive strength of the high-pressure resistant atomization nozzle reaches ≥30MPa; thus, the diameter of the atomized liquid medicine particles is accurately controlled within the extremely fine range of 5-10μm, and the atomization particle diameter of the liquid medicine is reduced by more than 80% compared with the atomization technology of the existing hyperthermic perfusion treatment.

[0067] Experimental data show that the cooperation of the power unit, the transmission unit and the high-pressure generating unit enables the pressurization pressure of the liquid medicine in the high-pressure generating unit to stably reach the ultra-high pressure of 8.0MP±0.5; and through this ultra-high pressure, the liquid medicine is atomized into liquid medicine particles in the range of 5-10μm in diameter, which can enable the liquid medicine to penetrate the peritoneal mesothelial cell layer, improve the drug penetration depth and permeability, and significantly increase the effective drug concentration at the lesion site; Among them, when performing intraperitoneal atomization drug delivery, using liquid medicine particles in the range of 5-10μm in diameter can increase the penetration depth of the liquid medicine through the peritoneal mesothelial cell layer by 3-5 times, and make the local drug concentration at the site where the liquid medicine is sprayed through heating drug delivery reach 20-50 times that of intravenous injection, significantly increasing the effective drug concentration at the lesion site, thereby improving the targeting of drug delivery, achieving targeted drug delivery, reducing the accompanying side effects, improving the curative effect, and reducing the burden of the organ on metabolizing the drug.

[0068] Meanwhile, the real-time pressure feedback from the temperature and pressure unit to the central control module ensures the stability and reliability of the liquid medicine atomization process, avoiding the agglomeration of liquid medicine particles or the blockage of the atomizing nozzle at the atomizing end caused by sudden pressure changes. Among them, the real-time pressure feedback from the temperature and pressure unit to the central control module enables the pressure fluctuation of the liquid medicine to be controlled within ±0.5 MPa.

[0069] (2)Enhancing the treatment targeting through thermo-mechanical synergy Integrating the closed-loop control algorithm of the temperature and pressure unit and the central control module to achieve the synergy between the heating of the liquid medicine and the heating of the abdominal cavity gas; in the heated drug delivery environment, the diffusion coefficient of the atomized liquid medicine particles is increased by 1.8 - 2.3 times. At the same time, high temperature induces an increase in the permeability of the tumor cell membrane, which helps the drug to reach the lesion directly, enhancing the effect of the drug and improving the targeting of drug treatment to achieve precise drug delivery and precise treatment.

[0070] Among them, the closed-loop control algorithm applied by the central control module includes PWM control or PID + PWM regulation; the temperature range for heating the liquid medicine is controlled at 35 - 45 °C, and the temperature range for heating the abdominal cavity gas is controlled at 38 - 43 °C; through the synergy of heating the liquid medicine and heating the abdominal cavity gas, a heated drug delivery environment is formed. In the heated drug delivery environment, the diffusion coefficient of the atomized liquid medicine particles is increased by 1.8 - 2.3 times. At the same time, high temperature induces an increase in the permeability of the tumor cell membrane, and the cell membrane permeability has a significant increase at 42 °C.

[0071] The pressure data of the abdominal cavity gas and the temperature data of the abdominal cavity gas collected by the sensor are collected in real time through the SPI bus to ensure that the environment for heating and atomizing the drug for treatment conforms to the optimal window of thermodynamics, and the error of the temperature of the atomized liquid medicine particles reaching the abdominal cavity and the temperature of the abdominal cavity gas is controlled within ±0.5 °C to avoid the risk of thermal injury.

[0072] (3)Improving the reliability of the abdominal atomizing drug delivery device through intelligent closed-loop control The central control module realizes dynamic regulation through multi-modal signal fusion: Adaptive compensation for liquid medicine pressure: When the atomizing end sprays liquid medicine in the abdominal cavity and encounters tissue adhesion, resulting in a sudden change in atomizing resistance, the power unit cooperates with the transmission unit to automatically adjust the injection speed of the liquid medicine to maintain a constant liquid medicine atomizing pressure. Among them, regarding the central control module through multi-modal signal fusion, the data signals collected by subordinate sensors such as the liquid medicine pressure, abdominal cavity gas pressure, liquid medicine temperature, abdominal cavity gas temperature, and atomized injection flow rate of the liquid medicine are fused here. In order to maintain a constant pressure for liquid medicine atomization, the power unit needs to cooperate with the transmission unit to automatically adjust the injection speed of the liquid medicine, and the response time of the control is controlled within 50 ms to improve the sensitivity of liquid medicine injection adjustment, so as to maintain a constant liquid medicine atomization pressure when atomizing the liquid medicine and injecting liquid medicine atomization particles.

[0073] Thermal balance mechanism: The central control module dynamically adjusts the heating power of the heating device for heating the liquid medicine and the heating device for heating the abdominal cavity gas according to the temperature data feedback of the abdominal cavity gas, avoiding local overheating of the abdominal cavity gas. Among them, the heating power of the heating device for heating the liquid medicine and the heating device for heating the abdominal cavity gas has an adjustable power accuracy of ±5W.

[0074] Purification linkage of abdominal cavity aerosol: The negative pressure unit and the atomized end of the high-pressure generating unit start, stop, and regulate the injection of liquid medicine particles synchronously, ensuring that the residual amount of abdominal cavity aerosol is controlled within 0.1 μg / m³, greatly reducing the risks of abdominal cavity infection and drug side effects. Among them, the suction efficiency of the negative pressure unit for the abdominal cavity reaches ≥5L / min, so that when the abdominal cavity pressure suddenly increases due to body position changes, the negative pressure unit can provide sufficient negative pressure suction, quickly adjust the pressure in the abdominal cavity, and achieve real-time follow-up control of the pressure in the abdominal cavity, ensuring that the residual amount of abdominal cavity aerosol is controlled within 0.1 μg / m³, and the residual amount of abdominal cavity aerosol is reduced by 90% compared with the traditional hyperthermic perfusion technique.

[0075] (4) Improve the treatment advantages of the abdominal cavity atomizing drug delivery device through multi-dimensional coordination Through the coordination of the power unit, transmission unit, high-pressure generating unit, negative pressure unit, and temperature and pressure unit, the triple coordination effects of ultra-high pressure atomization, heated atomization drug delivery, and closed-loop control of temperature and pressure are realized. When performing abdominal cavity atomizing drug delivery, after improving the drug efficacy, the effects of improving the tumor inhibition rate, significantly reducing side effects, and shortening the treatment cycle can be achieved. Among them, the triple coordination effects are respectively achieved by the ultra-high pressure atomization to achieve ultra-high penetration rate of the liquid medicine at the diseased site in the abdominal cavity, the heated liquid medicine atomization drug delivery to achieve thermal sensitization of the abdominal cavity and improve the liquid medicine absorption ability, and the closed-loop control of the liquid medicine temperature and pressure to achieve precise drug delivery. After enhancing the drug efficacy, the systemic blood drug concentration index of the liquid medicine entering the body is only 1 / 15 of that of intravenous injection, thus reducing the liver and kidney toxicity index. However, due to the high drug targeting, although the amount of drug administered is small, the efficacy of the drug is increased instead, and the side effects are significantly reduced; the treatment cycle is shortened, and the single treatment time is ≤ 30 minutes, which is greatly shortened compared with the 2-3 hours of treatment time required by traditional hyperthermic perfusion, and the equipment durability > 500 high-pressure cycles.

[0076] (5)The intraperitoneal atomization drug delivery device has high drug compatibility and scalability for drug delivery Modular design: The atomization end can be adapted to atomizing nozzles with different apertures, and can spray liquid medicine particles with different particle sizes from the atomization end according to different treatment plans, meeting the diverse intraperitoneal heating and high-pressure atomization drug delivery requirements from chemotherapeutic drugs to biological agents; Among them, the atomization end can be adapted to atomizing nozzles with different apertures, so as to realize that the atomization particle size is adjustable at 5-10 microns, 10-20μm, 20-50μm and 50-200μm; under different treatment plans, the atomization end sprays liquid medicine particles with different particle sizes, meeting the diverse drug delivery requirements of various drugs from chemotherapeutic drugs such as paclitaxel to biological agents such as PD-1 antibody.

[0077] Data interconnection: The central control module collects the treatment parameters of intraperitoneal atomization drug delivery, retains the treatment data for subsequent use, and even stores it in the cloud, conducts AI-assisted analysis of the drug delivery power, pharmacology and effect of the treatment plan, and provides data support for formulating personalized intraperitoneal atomization drug delivery treatment plans according to different conditions in the future, so as to be able to give a better treatment plan, maximize the drug effect of the treatment, and relieve the pain of patients; Among them, through the analysis of the treatment data, the best atomization particle size and heating temperature can also be recommended according to the tumor type, so as to be able to give a better treatment plan.

[0078] In summary, the present invention realizes ultra-high pressure atomization particle size control through a power unit, a transmission unit and a high-voltage generation unit, realizes thermo-mechanical synergistic enhancement of drug penetration through a temperature and pressure unit and a negative pressure unit, the central control module collects data from sensors and performs intelligent closed-loop regulation, and a multi-unit integrated structure, which reduces the particle size of the atomized liquid medicine, makes the atomized particles of the liquid medicine evenly distributed at the diseased site in the abdominal cavity, improves the drug penetration depth and penetration rate, thereby improving the accuracy and efficacy of intraperitoneal atomized drug administration, reducing the side effects of intraperitoneal drug administration, and solving the technical problems of large atomization particle size, low atomization uniformity, lack of thermo-mechanical synergy and low high-voltage stability existing in the existing liquid medicine atomization devices for intraperitoneal drug administration, providing an efficient, accurate and safe intraperitoneal high-pressure atomized drug administration technical solution for the local treatment of abdominal tumors and peritoneal diseases; and the technical indicators such as the atomization particle size, pressure stability and thermal control accuracy of the intraperitoneal atomized drug administration instrument of the present invention all reach the international leading level and have significant clinical application value.

[0079] As one of the optional implementation manners, Regarding the specific structure of the above-mentioned explosion-proof syringe, the barrel of the explosion-proof syringe is a thickened disposable barrel.

[0080] Specifically, regarding the material of the barrel of the explosion-proof syringe, the barrel of the explosion-proof syringe is made of materials resistant to high pressure and corrosion.

[0081] When in application, the materials resistant to high pressure and corrosion used for the barrel include high-performance materials such as medical-grade stainless steel, medical-grade plastic, medical-grade ceramic and medical-grade composite materials.

[0082] Due to the particularity of intraperitoneal high-pressure atomized drug administration, the composition of its drugs is relatively complex and sensitive to stability, and even has a certain amount of radioactivity; so the explosion-proof syringe for loading the liquid medicine needs to be disposable and has the characteristics of being resistant to high pressure and corrosion, and also needs to avoid the problem of impurities released by metals under high pressure and highly corrosive liquid medicine, as well as the consideration of the one-time cost of the explosion-proof syringe.

[0083] Therefore, it is more reasonable to choose medical-grade plastic as the material of the explosion-proof syringe.

[0084] One of the implementation manners of the above-mentioned transmission unit can be a lead screw and nut transmission structure.

[0085] Specifically, the transmission unit includes a transmission lead screw and a transmission nut, the output end of the power unit is in transmission connection with the transmission lead screw or the transmission nut, the power unit transmits the output rotation to the transmission lead screw or the transmission nut, and the transmission lead screw or the transmission nut converts the rotation into displacement and transmits it to the piston.

[0086] When in application, the lead screw nut transmission structure has the function of converting the rotational motion of the power unit into a displacement motion. The lead screw has high repeat positioning accuracy and small axial clearance, and is suitable for precisely controlling the displacement of the piston of the high-pressure generating unit in cooperation with the power unit, so as to precisely control the injection volume. Moreover, the liquid medicine needs to use ultra-high pressure to achieve extremely fine atomization of the liquid medicine particles. The lead screw nut transmission structure has a self-locking function, can withstand large axial forces, and can easily amplify and convert the torque into a huge axial pressure applied to the piston with the power unit cooperating with the reduction gearbox. Therefore, it is suitable to be used as the transmission unit structure for high-pressure atomization drug delivery.

[0087] Figure 3 It is the third schematic diagram of the control principle of the abdominal cavity atomization drug delivery instrument of the present invention.

[0088] Regarding the specific structure of the above-mentioned power unit, in this embodiment, Figure 3 As shown, the power unit is a servo power source. The power unit consists of a servo motor and a servo driver. The output end of the servo motor is connected to the input end of the transmission unit, and the transmission unit receives the rotation of the servo motor; the servo driver is electrically connected to the servo motor, and the servo driver is electrically connected to the central control module, receiving the data of the central control module controlling the piston to start displacement, stop displacement, and the distance and speed of displacement.

[0089] When in application, the servo driver receives the command signal from the central control module. The servo driver controls the servo motor to rotate. The servo motor transmits the rotational motion to the transmission unit, driving the piston in the high-pressure generating unit to move, generating a linear pressure of 5-9 MPa on the liquid medicine; based on the built-in PID algorithm, the servo driver adjusts the torque and speed of the servo motor in real time to ensure that the atomization pressure fluctuation range ≤ ±0.5 MPa, avoiding excessive fluctuation in the particle size of the liquid medicine atomization particles caused by sudden changes in resistance; the pressure of the piston delivering the liquid medicine is monitored in real time through a sensor, and the pressure data is fed back to the central control module, thereby dynamically correcting the speed of the servo motor to achieve stable atomization output of the liquid medicine at the atomization end under ultra-high pressure atomization.

[0090] The power assembly composed of the servo-controlled power unit and the transmission unit breaks through the pressure hysteresis problem of the traditional pneumatic and hydraulic drive systems, and can still maintain the uniformity of the particle size of the liquid medicine atomization at the atomization end under ultra-high pressure conditions.

[0091] Figure 4 It is the fourth schematic diagram of the control principle of the abdominal cavity atomization drug delivery instrument of the present invention.

[0092] In addition, in order to increase the closed-loop control of the power unit, in this embodiment, Figure 4 As shown, a rotation sensor is installed on the power unit.

[0093] Furthermore, the rotation sensor is electrically connected to the servo driver of the power unit.

[0094] During application, the rotation sensor is used to detect the number of rotation cycles and the rotation speed output by the power unit, and feedback the data of the number of rotation cycles and the rotation speed output by the power unit to the central control module.

[0095] Specifically, when the power unit is a servo motor power component, the rotation sensor is an optical encoder. The optical encoder is installed on the shaft of the servo motor. When the shaft of the servo motor rotates, it drives the code disk of the optical encoder to rotate together. By detecting the rotation of the code disk, data such as the motion state, the number of motion cycles, and the motion angle of the servo motor shaft are identified.

[0096] The rotation sensor is electrically connected to the servo driver, feeds back the measured servo motor data to the servo driver, and controls the rotation of the servo motor through the servo driver to form a closed-loop control. At the same time, the servo driver receives the control information from the central control module, thereby forming a data exchange with the power unit and forming an intelligent closed-loop regulation of output and feedback.

[0097] One implementation of the above transmission unit and power unit can be that the power unit can be a magnetic drive mechanism, the transmission unit can be a push rod and a guide rod. One end of the push rod is connected to the piston, and the other end is connected to the output end of the magnetic drive mechanism. The guide rod is connected to the push rod through a slider. Under the guidance of the guide rod, the push rod is pushed by the output end of the magnetic drive mechanism to give power to the piston, pressurize the liquid medicine, so that the liquid medicine has enough pressure to be atomized in the atomizing nozzle.

[0098] In order to prevent the power of the magnetic drive mechanism from suddenly failing, resulting in the loss of pressure of the liquid medicine and the gas or liquid in the abdominal cavity being suddenly sucked out due to the loss of pressure, causing the risk of loss of pressure in abdominal cavity atomization drug delivery, a self-locking mechanism is provided at the output end of the magnetic drive mechanism or on the push rod to prevent the output end of the magnetic drive mechanism or the push rod from generating a backward stroke after losing power.

[0099] Specifically, the self-locking mechanism can be one of a ratchet mechanism, a worm and worm gear, or a worm and gear mechanism.

[0100] Figure 5 It is the fifth schematic diagram of the control principle of the abdominal cavity atomization drug delivery device of the present invention.

[0101] Regarding the specific structure of the above negative pressure unit, this embodiment is as Figure 5 shown. The negative pressure unit includes a suction component, a filtering component, and a suction pipe; Specifically, the suction component is electrically connected to the central control module; the suction pipe is used to extend into the abdominal cavity and suck out the abdominal cavity aerosol with the negative pressure suction generated by the suction component. The sucked abdominal cavity aerosol is filtered and purified by the filtering component and then discharged.

[0102] During application, the suction component sucks the abdominal aerosol according to the negative pressure value set by the central control module. Through the algorithm of the central control module, it coordinates with the power unit, transmission unit, and high-voltage generating unit to dynamically match the suction efficiency with the atomization injection rate; through the dynamically adjusted suction and spray coordination mechanism, efficient aerosol purification in the abdominal cavity is achieved.

[0103] Regulated by the central control module, with the power unit, transmission unit, high-voltage generating unit, and negative pressure unit as the executors, a full-process closed-loop control of atomization-suction-purification is achieved. 99.9% of the residual aerosol can be removed during a single treatment, avoiding systemic toxicity caused by drug diffusion, while maintaining the gas pressure balance in the abdominal cavity and preventing pneumoperitoneum complications.

[0104] Among them, in order to ensure that the aerosol in the abdominal cavity can be sucked out completely, an aerosol sensor for monitoring the aerosol content in the abdominal cavity is installed on the suction pipe extending into the abdominal cavity, so that the central control module can receive the data of the aerosol sensor, thereby monitoring the abdominal aerosol content in the abdominal cavity, calculating the current aerosol residue in the abdominal cavity, verifying whether the aerosol in the abdominal cavity has been sucked out cleanly, and ensuring that the aerosol in the abdominal cavity is sucked out cleanly through the cooperation of detecting the aerosol content in the abdominal cavity and the suction component.

[0105] Regarding the specific structure of the above temperature and pressure unit and the connection method of each component to the temperature and pressure unit, the temperature and pressure unit includes a liquid medicine heater, a first temperature sensor, and a second temperature sensor that are electrically connected to the central control module; the liquid medicine heater is arranged on the high-voltage generating unit and heats the liquid medicine loaded in the high-voltage generating unit to reach the preset temperature of the central control module; the detection end of the first temperature sensor is arranged on or inside the high-voltage generating unit, and is used to measure the real-time temperature of the liquid medicine by contacting or non-contacting the liquid medicine; the detection end of the second temperature sensor is arranged on the liquid medicine heater; and an abdominal cavity heater, a third temperature sensor, and a fourth temperature sensor that are electrically connected to the central control module; the abdominal cavity heater is arranged on the abdomen; the detection end of the third temperature sensor extends into the abdominal cavity to detect the temperature of the abdominal cavity gas, and the detection end of the fourth temperature sensor is arranged on the abdominal cavity heater; and an abdominal cavity pressure sensor that is electrically connected to the central control module, and the detection end of the abdominal cavity pressure sensor extends into the abdominal cavity to detect the pressure of the abdominal cavity gas.

[0106] During application, the first temperature sensor is used to monitor the real-time temperature of the liquid medicine; the second temperature sensor is used to monitor the output temperature of the liquid medicine heater and transmit the data of the real-time temperature of the liquid medicine and the output temperature of the liquid medicine heater to the central control module, and the central control module performs closed-loop control on the real-time temperature of the liquid medicine and the liquid medicine heater; The control logic of the central control module for the closed-loop control of the real-time temperature of the liquid medicine and the liquid medicine heater. The liquid medicine heating is started through the liquid medicine heater. The first temperature sensor monitors the real-time temperature of the liquid medicine and feeds back the liquid medicine temperature information to the main control IC of the central control module. For example, when the temperature is higher than 43 degrees Celsius, the heating is stopped; when the temperature is lower than 40 degrees Celsius, the heating is started. The main control IC controls the carbon fiber heating wire in the liquid medicine heater to heat the liquid medicine by combining the real-time temperature of the liquid medicine fed back by the first temperature sensor through the PID feedback algorithm. The second temperature sensor transmits the real-time heating output temperature of the carbon fiber heating wire collected back to the main control IC, and controls the heating frequency and heat output of the carbon fiber heating wire through PWM to keep its heating temperature in a constant temperature state with a temperature error of 0.5 degrees Celsius, thereby controlling the temperature of the heated liquid medicine in a closed-loop manner and keeping the liquid medicine temperature between 40 and 43 degrees Celsius.

[0107] The abdominal cavity heater is used to heat the abdomen and conduct heat to the abdominal cavity gas in the abdominal cavity to raise the temperature of the abdominal cavity gas to the preset temperature of the central control module. The third temperature sensor is used to monitor the real-time temperature of the abdominal cavity gas, and the fourth temperature sensor is used to monitor the output temperature of the abdominal cavity heater, and transmits the real-time temperature data of the abdominal cavity gas and the output temperature data of the abdominal cavity heater to the central control module. The central control module conducts closed-loop control on the real-time temperature of the abdominal cavity gas and the abdominal cavity heater. The control logic of the central control module for the closed-loop control of the real-time temperature of the abdominal cavity gas and the abdominal cavity heater. The abdominal cavity gas heating is started through the abdominal cavity heater. The third temperature sensor monitors the real-time temperature of the abdominal cavity gas and feeds back the abdominal cavity gas temperature information to the main control IC of the central control module. For example, when the temperature is higher than 43 degrees Celsius, the heating is stopped; when the temperature is lower than 38 degrees Celsius, the heating is started. The main control IC controls the carbon fiber heating wire in the abdominal cavity heater to heat the abdominal cavity gas by combining the real-time temperature of the abdominal cavity gas fed back by the third temperature sensor through the PID feedback algorithm. The fourth temperature sensor transmits the real-time heating output temperature of the carbon fiber heating wire collected back to the main control IC, and controls the heating frequency and heat output of the carbon fiber heating wire through PWM to keep its heating temperature in a constant temperature state with a temperature error of 0.5 degrees Celsius, thereby controlling the temperature of the heated abdominal cavity gas in a closed-loop manner and keeping the abdominal cavity gas temperature between 38 and 43 degrees Celsius.

[0108] The abdominal cavity pressure sensor is used to monitor the abdominal cavity air pressure and transmits the abdominal cavity air pressure data to the central control module. The central control module combines with the power unit to control the pressure and flow rate of the atomized liquid medicine ejected by the high-pressure generating unit and the pressure and flow rate of the negative pressure unit sucking out the abdominal cavity aerosol, and cooperatively controls the abdominal cavity air pressure in a closed-loop control manner to maintain the stability of the abdominal cavity air pressure. In order to achieve the abdominal cavity environment required for atomization therapy, an air blower is also provided. The air blower is electrically connected to the central control module and is provided with an air pipe for extending into the abdominal cavity.

[0109] The central control module jointly controls the control logic of the abdominal cavity air pressure in a closed-loop manner with the power unit, the high-voltage generating unit, and the negative pressure unit. The abdominal cavity heater is started to heat the abdominal cavity gas. The abdominal cavity pressure sensor collects the current abdominal cavity air pressure value and converts it into an electrical signal to be sent back to the main control IC. The main control IC controls the air blowing volume through the PID feedback algorithm. When the abdominal cavity air pressure monitored by the abdominal cavity pressure sensor reaches 12 mmHg, the pressurization action of the air blower on the abdominal cavity is stopped. At the same time, after the abdominal cavity air pressure reaches the set pressure value and the air blower stops, the abdominal cavity heater, the power unit, the high-voltage generating unit, and the negative pressure unit are turned on for internal circulation in the abdominal cavity to maintain the temperature of the gas in the abdominal cavity. When the air pressure drops, the air blower is started to supplement the pressure, thereby forming a closed-loop control of the abdominal cavity air pressure to maintain the stability of the abdominal cavity air pressure.

[0110] In order to obtain specific information about the position of the piston on the high-voltage generating unit, thereby assisting the central control module to better control the displacement of the piston and accurately control the injection volume; in addition, in order to accurately control the pressure of atomization drug delivery, it is also necessary to monitor the pressure of the liquid medicine on the high-voltage generating unit under the extrusion of the piston.

[0111] Figure 8 It is the eighth schematic diagram of the control principle of the abdominal cavity atomization drug delivery instrument of the present invention.

[0112] Specifically, as shown in this embodiment Figure 8 As shown, a limit module, a position detection module, and a liquid medicine pressure module electrically connected to the central control module are installed on the high-voltage generating unit, and data interaction is carried out. The limit module is used to obtain the starting position and the final position of the piston and feedback the data of the starting position and the final position of the piston to the central control module. The position detection module is used to obtain the current position of the piston, feedback the current position data of the piston to the central control module, and calculate the current liquid medicine injection volume through the built-in algorithm of the central control module. The liquid medicine pressure module is used to detect the current pressure of the liquid medicine in the high-voltage generating unit and feedback the current pressure data of the liquid medicine to the central control module.

[0113] Among them, regarding the specific structure of the above-mentioned limit module, the limit module is provided with an upper limit sensor and a lower limit sensor. The upper limit sensor and the lower limit sensor can be respectively arranged at the starting position and the final position of the piston moving in the high-voltage generating unit for obtaining the data of the starting position and the final position of the piston.

[0114] During application, the central control module controls the atomization degree of the liquid medicine and the injection volume of the liquid medicine in a closed-loop control manner by obtaining the starting position, final position and current position of the piston, obtaining the current pressure data of the liquid medicine in the high-pressure generating unit, and obtaining the number of rotation turns and rotation speed data output by the power unit, thereby coordinating the power unit, the transmission unit and the high-pressure generating unit; thus accurately controlling the internal high-pressure drug delivery execution parameters such as the injection volume, aiming to achieve the functions of precise quantitative drug delivery and controllable atomization pressure at the atomization end, thereby improving the reliability of the peritoneal atomization drug delivery instrument.

[0115] In another embodiment, the limit module and the position detection module can be combined into a vision sensor or a laser scanning position sensor to detect the starting position, final position and current position of the piston in real time; instead of arranging sensors at multiple detection positions along the moving path of the piston.

[0116] The second embodiment of the peritoneal atomization drug delivery instrument. The difference between this embodiment and the first embodiment is that the explosion-proof syringe includes a barrel, an explosion-proof shell and a piston; the explosion-proof shell is sleeved outside the barrel, one end of the explosion-proof shell is hermetically connected to the outer wall of the liquid outlet end of the barrel and is provided with a hole extending out of the liquid outlet end; the other end of the explosion-proof shell is provided with an openable and closable sealing member; the sealing member is used for replacing the barrel when opened and for allowing the moving end of the transmission unit to pass through and seal the outer wall of the moving end when closed.

[0117] During application, the function of setting the sealing member on the explosion-proof shell is to prevent the liquid medicine from flowing out of both ends of the explosion-proof shell after the barrel bursts during replacement.

[0118] The third embodiment of the peritoneal atomization drug delivery instrument. The difference between this embodiment and the first embodiment is that regarding the specific structural connection and power transmission of the transmission screw, the transmission nut and the power unit, when the transmission screw receives the rotation of the power unit, the transmission nut moves linearly along the axis of the transmission screw, and the transmission nut transmits the displacement to the piston; the transmission unit is also provided with a guide rod, and the guide rod is slidably connected to the transmission nut; a push rod is also provided between the transmission nut and the piston, the push rod connects the transmission nut and the piston, and the piston and the push rod are detachably separable.

[0119] During application, the push rod provided between the transmission nut and the piston is used to limit the rotational freedom of the transmission nut, so that the transmission nut converts the rotation of the transmission screw into displacement through the thread engagement with the transmission screw.

[0120] The fourth embodiment of the peritoneal atomization drug delivery instrument. The difference between this embodiment and the first embodiment is that when the transmission nut receives the rotation of the power unit, at this time the transmission nut serves as the main driving part and the transmission screw serves as the driven part.

[0121] When in application, the transmission lead screw moves linearly along the axis of the transmission nut, and the transmission lead screw transfers the displacement to the piston; the transmission unit is provided with a rotating base, the transmission nut is rotatably installed on the rotating base, the power unit is rotatably connected to the transmission nut to drive the transmission nut to rotate; the transmission lead screw passes through the central screw hole of the transmission nut, and the transmission nut drives the transmission lead screw to move.

[0122] Figure 6 It is the sixth schematic diagram of the control principle of the abdominal cavity atomization drug delivery device of the present invention.

[0123] The fifth embodiment of the abdominal cavity atomization drug delivery device is as Figure 6 shown. The difference between this embodiment and the first embodiment is that one of the connection sequences of the components of the negative pressure unit is: along the direction of extracting the abdominal cavity aerosol, a suction pipe, a filtering component, and a suction component are connected in sequence.

[0124] Specifically, the connection method is that the suction component is connected to the air outlet end of the filtering component through a pipeline, and the suction pipe is connected to the air inlet end of the filtering component.

[0125] When in application, the filtering component is filled with a purification liquid. By introducing the abdominal cavity aerosol inhaled by the suction pipe into the purification liquid, after the pollutants in the abdominal cavity aerosol are absorbed by the purification liquid, a purified gas is released. The purified gas enters the suction component through the air outlet end of the filtering component and is then discharged through the suction component.

[0126] Figure 7 It is the seventh schematic diagram of the control principle of the abdominal cavity atomization drug delivery device of the present invention.

[0127] The sixth embodiment of the abdominal cavity atomization drug delivery device is as Figure 7 shown. The difference between this embodiment and the first embodiment is that one of the connection sequences of the components of the negative pressure unit is: along the direction of extracting the abdominal cavity aerosol, a suction pipe, a suction component, and a filtering component are connected in sequence.

[0128] Specifically, the suction pipe is connected to the negative pressure end of the suction component, and the exhaust end of the suction component is connected to the filtering component through a pipeline.

[0129] When in application, the suction component introduces the aspirated abdominal cavity aerosol into the air inlet end of the filtering component; the filtering component is filled with a purification liquid, the abdominal cavity aerosol is introduced into the purification liquid, after the pollutants in the abdominal cavity aerosol are absorbed by the purification liquid, a purified gas is released, and the purified gas is discharged through the air outlet end of the filtering component.

[0130] Figure 9 It is the ninth schematic diagram of the control principle of the abdominal cavity atomization drug delivery device of the present invention.

[0131] The seventh embodiment of the abdominal cavity atomization drug delivery device is as Figure 9As shown, the difference between this embodiment and the first embodiment is that a liquid mass sensor is provided in the purified liquid of the filtering component, and the liquid mass sensor is electrically connected to the central control module.

[0132] During application, the liquid mass sensor is used to monitor the pollution degree of the purified liquid, output the pollution data of the purified liquid to the central control module, and the central control module judges the pollution degree or cleanliness of the purified liquid through the built-in algorithm.

[0133] Specifically, the central control module judges the pollution degree or cleanliness of the purified liquid of the filtering component through the algorithm and displays it on the display, so as to remind the operator to replace the purified liquid of the filtering component in time.

[0134] Figure 10 It is the tenth schematic diagram of the control principle of the abdominal cavity atomization drug delivery instrument of the present invention.

[0135] The eighth embodiment of the abdominal cavity atomization drug delivery instrument is as Figure 10 As shown, the difference between this embodiment and the first embodiment is that a gas mass sensor is provided inside or outside the air outlet end of the filtering component on the path of discharging the purified gas.

[0136] Among them, the inside of the air outlet end of the filtering component refers to the inside of the position where the exhaust pipe is connected to the air outlet end, and the outside of the air outlet end of the filtering component refers to the inside of the exhaust pipe connected to the air outlet end.

[0137] During application, the gas mass sensor is used to monitor the pollution degree of the purified gas, output the pollution data of the purified gas to the central control module, and the central control module judges the pollution degree or cleanliness of the purified gas through the built-in algorithm.

[0138] Specifically, after the central control module judges the pollution degree or cleanliness of the discharged purified gas, it further judges the pollution degree or cleanliness of the purified liquid of the filtering component through the algorithm and displays it on the display, so as to remind the operator to replace the purified liquid of the filtering component in time.

[0139] Among them, when it is detected and judged that the purified liquid needs to be replaced in the manner of Embodiment 7 or 8, a waste liquid container can be arranged under the filtering component, connected to the inner cavity of the filtering component for carrying the purified liquid through a drain pipe, and a drain electric control valve is arranged on the drain end of the drain pipe and the inner cavity of the filtering component for carrying the purified liquid. The drain electric control valve is electrically connected to the central control module, and the central control module controls the opening or closing of the drain electric control valve to control the drainage; A solution tank is arranged above the filtering component. The solution tank holds spare purified liquid. The solution tank is connected to the inner cavity of the filtering component that holds the purified liquid through a liquid inlet pipe. And on the liquid inlet path, such as at the liquid outlet end of the solution tank, the liquid inlet pipe or the liquid inlet end of the inner cavity of the filtering component that holds the purified liquid, a liquid inlet electric control valve is arranged. The liquid inlet electric control valve is electrically connected to the central control module. The central control module controls the opening or closing of the liquid inlet electric control valve, so as to control that after discharging the waste liquid, new purified liquid is automatically replenished from the solution tank to the inner cavity of the filtering component that holds the purified liquid.

[0140] In Example 8, when the pollution degree of the purified gas is monitored by a gas mass sensor and the central control module determines that the pollution degree or cleanliness of the discharged purified gas does not meet the emission standard or purification standard, a three-way air valve and a gas return pipe can be set. The three-way air valve is installed between the air outlet end of the filtering component, the exhaust pipe and the gas return pipe, and the three-way air valve connects the air outlet end of the filtering component, the exhaust pipe and the gas return pipe. The other end of the gas return pipe is connected to the air inlet end of the filtering component. A one-way valve is installed between the gas return pipe and the air inlet end of the filtering component, and only allows the reflux gas to flow back from the air outlet end of the filtering component to the air inlet end; thus, the purified gas that does not meet the emission standard or purification standard is refluxed to the air inlet end of the filtering component for further purification to meet the emission standard or purification standard.

[0141] Regarding the specific structure and control method of the three-way air valve, the three-way air valve is an electric air valve. The three-way air valve is electrically connected to the central control module. The central control module controls the three-way air valve to connect the air outlet end of the filtering component with the exhaust pipe, or the air outlet end of the filtering component with the gas return pipe.

[0142] Based on the above embodiments of the intraperitoneal atomization drug delivery device, a sterile protection operation sleeve is provided, including a sterile operation sleeve and the above intraperitoneal atomization drug delivery device.

[0143] Specifically, the sterile operation sleeve is sleeved on the abdominal wound for isolating the abdominal cavity wound from the external environment, forming a sterile environment inside the sterile operation sleeve for the atomization end to extend into the abdominal cavity to be treated in a sterile manner for high-pressure atomization internal drug delivery treatment.

[0144] When in application, by using the sterile operation sleeve for high-pressure atomization drug delivery in the abdominal cavity, the postoperative infection rate can be reduced, and there is no need to interrupt the operation to replace the sealing component during a single treatment, significantly improving the safety and efficiency of high-pressure atomization drug delivery treatment in the abdominal cavity.

[0145] Figure 11 It is a schematic diagram of the control principle of the intraperitoneal atomization drug delivery device and the PC terminal processor of the present invention.

[0146] Based on the above embodiments of the intraperitoneal atomization drug delivery device, a PC terminal processor is provided, characterized in that, as Figure 11As shown, it includes a PC processing unit and the above-mentioned intraperitoneal atomization drug delivery device.

[0147] Specifically, the PC processing unit is electrically connected to the central control module and conducts data interaction, used to receive the drug delivery data set by the user and convert it into interaction data to be transmitted to the central control module.

[0148] Among them, the PC processing unit reads the data of the power unit; the central processing module conducts data interaction with the power unit.

[0149] During application, by electrically connecting the PC processing unit to the central control module and conducting data interaction, the operator can set the treatment parameters through the PC-side processor, thereby improving the setting efficiency of the treatment parameters for intraperitoneal high-pressure atomization drug delivery, and increasing the standardization degree of the treatment process, meeting the requirements of precision medicine and medical data compliance.

[0150] Figure 12 It is a schematic diagram of the control principle of the interactor and the PC-side processor of the present invention.

[0151] Based on the above embodiments of the intraperitoneal atomization drug delivery device, an interactor is provided, as Figure 12 shown, including an operation screen and the above-mentioned PC-side processor.

[0152] Specifically, the operation screen is electrically connected to the PC processing unit and conducts data interaction, used to allow the user to set the drug delivery instruction and convert it into an interaction instruction to be transmitted to the PC processing unit.

[0153] During application, by conducting data interaction between the operation screen of the interactor and the PC-side processor, through this design, the complex operation steps when the operator uses the intraperitoneal atomization drug delivery device are simplified to within 3 steps, the efficiency of setting the treatment parameters is also improved, the misoperation rate can be reduced, and the use training cycle of the intraperitoneal atomization drug delivery device is further shortened, significantly reducing the risk of medical errors.

[0154] The technical features of the above embodiments can be combined arbitrarily. For the sake of brief description, not all possible combinations of the technical features in the above embodiments are described.

Claims

1. An abdominal cavity atomizing drug delivery device, characterized in that it includes a high-pressure generating unit, and the atomizing end of the high-pressure generating unit extends into the abdominal cavity to be treated for atomizing and spraying the loaded liquid medicine on the affected area; a power unit and a transmission unit, the power unit drives the transmission unit, and the transmission unit pushes the piston in the high-pressure generating unit to apply ultra-high pressure to the liquid medicine, so that the liquid medicine is ejected in the form of extremely fine mist particles; a negative pressure unit, the negative pressure end of the negative pressure unit extends into the abdominal cavity to suck out the generated abdominal cavity aerosol and filter it for harmless treatment; a temperature and pressure unit, the temperature and pressure unit is provided with a plurality of heating devices and sensors, and controls the heating devices to heat the liquid medicine and the abdominal cavity gas through PWM, and reads the liquid medicine temperature, abdominal cavity gas temperature and abdominal cavity gas pressure through SPI; a central control module, the central control module receives the set data of the operator as the operation index, and is electrically connected to control the power unit, the transmission unit, the negative pressure unit and the temperature and pressure unit to cooperate with each other, perform information interaction to form a closed-loop control, and complete the coordinated action control of the atomization degree of the liquid medicine, the liquid medicine temperature, the liquid medicine injection volume, the abdominal cavity gas temperature, the abdominal cavity gas pressure and the exhaust purification, so as to realize high-pressure atomization heating drug delivery treatment in the abdominal cavity.

2. The abdominal cavity atomizing drug delivery device according to claim 1, characterized in that the high-pressure generating unit includes an explosion-proof syringe, a liquid pipe and an atomizing nozzle, and the liquid pipe is a high-pressure resistant pipe; the explosion-proof syringe is loaded with liquid medicine for drug delivery treatment, and both ends of the liquid pipe are respectively connected to the liquid outlet end of the explosion-proof syringe and the liquid inlet end of the atomizing nozzle; the atomizing end is arranged on the atomizing nozzle; the piston is arranged in the explosion-proof syringe, one end of the piston contacts the liquid medicine, and the other end is connected to the moving end of the transmission unit.

3. The abdominal cavity atomizing drug delivery device according to claim 2, characterized in that the particle size of the mist particles atomized and ejected by the atomizing nozzle is less than or equal to 10 μm, and the ultra-high pressure is 5-9 MPa.

4. The abdominal cavity atomizing drug delivery device according to claim 2, characterized in that the barrel of the explosion-proof syringe is a thickened disposable barrel.

5. The abdominal cavity atomizing drug delivery device according to claim 4, characterized in that the barrel of the explosion-proof syringe is made of a material resistant to high pressure and corrosion.

6. The abdominal cavity atomizing drug delivery device according to any one of claims 2 or 4, characterized in that the explosion-proof syringe includes a barrel, an explosion-proof shell and the piston; the explosion-proof shell is sleeved outside the barrel, one end of the explosion-proof shell is hermetically connected to the outer wall of the liquid outlet end of the barrel and is provided with a hole for the liquid outlet end to extend out; the other end of the explosion-proof shell is provided with an openable and closable sealing member; the sealing member is used for replacing the barrel when opened, and for the moving end of the transmission unit to pass through and seal the outer wall of the moving end when closed.

7. The abdominal cavity atomizing drug delivery device according to claim 1, characterized in that The transmission unit includes a transmission lead screw and a transmission nut. The output end of the power unit is in transmission connection with the transmission lead screw or the transmission nut. The power unit transmits the output rotation to the transmission lead screw or the transmission nut, and the transmission lead screw or the transmission nut converts the rotation into displacement and transmits it to the piston.

8. The abdominal cavity atomization drug delivery device according to claim 7, wherein When the transmission lead screw receives the rotation of the power unit, the transmission nut moves linearly along the axis of the transmission lead screw, and the transmission nut transmits the displacement to the piston; The transmission unit is further provided with a guide rod, and the guide rod is slidably connected to the transmission nut; A push rod is further provided between the transmission nut and the piston. The push rod connects the transmission nut and the piston, and the piston and the push rod are detachably separable.

9. The abdominal cavity atomization drug delivery device according to claim 7, wherein When the transmission nut receives the rotation of the power unit, the transmission lead screw moves linearly along the axis of the transmission nut, and the transmission lead screw transmits the displacement to the piston; The transmission unit is provided with a rotating base, the transmission nut is rotatably installed on the rotating base, and the power unit is rotatably connected to the transmission nut to drive the transmission nut to rotate; The transmission lead screw passes through the central screw hole of the transmission nut, and the transmission nut drives the transmission lead screw to move.

10. The abdominal cavity atomization drug delivery device according to claim 1, wherein The power unit includes a servo motor and a servo driver. The output end of the servo motor is connected to the input end of the transmission unit, and the transmission unit receives the rotation of the servo motor; The servo driver is electrically connected to the servo motor, and the servo driver is electrically connected to the central control module to receive the data of the central control module for controlling the piston to start displacement, stop displacement, and the distance and speed of displacement.

11. The abdominal cavity atomization drug delivery device according to claim 1, wherein The negative pressure unit includes a suction component, a filtering component, and a suction pipe; The suction pipe is used to extend into the abdominal cavity and suck out the abdominal cavity aerosol with the negative pressure generated by the suction component. The sucked abdominal cavity aerosol is filtered and purified by the filtering component and then discharged.

12. The abdominal cavity atomization drug delivery device according to claim 11, wherein The suction component is connected to the air outlet end of the filtering component through a pipeline, and the suction pipe is connected to the air inlet end of the filtering component; The filtering component is filled with a purification liquid. By introducing the abdominal cavity aerosol sucked by the suction pipe into the purification liquid, the pollutants of the abdominal cavity aerosol are absorbed by the purification liquid and then the purified gas is released. The purified gas enters the suction component through the air outlet end of the filtering component and is then discharged through the suction component.

13. The abdominal cavity atomization drug delivery device according to claim 11, wherein The suction pipe is connected to the negative pressure end of the suction component, the exhaust end of the suction component is connected to the filtering component through a pipeline, and the suction component introduces the sucked abdominal cavity aerosol into the air inlet end of the filtering component; The filtering component is filled with a purification liquid. The abdominal cavity aerosol is introduced into the purification liquid. After the pollutants in the abdominal cavity aerosol are absorbed by the purification liquid, a purified gas is released, and the purified gas is discharged from the air outlet end of the filtering component.

14. The abdominal cavity atomization drug delivery device according to any one of claims 11 to 13, characterized in that, A liquid mass sensor is arranged in the purification liquid of the filtering component. The liquid mass sensor is electrically connected to the central control module and is used for monitoring the pollution degree of the purification liquid, outputting the pollution data of the purification liquid to the central control module, and the central control module judges the pollution degree or cleanliness of the purification liquid through a built-in algorithm.

15. The abdominal cavity atomization drug delivery device according to claim 14, wherein, On the inner or outer side of the air outlet end of the filtering component, a gas mass sensor is arranged on the path of discharging the purified gas and is used for monitoring the pollution degree of the purified gas, outputting the pollution data of the purified gas to the central control module, and the central control module judges the pollution degree or cleanliness of the purified gas through a built-in algorithm.

16. The abdominal cavity atomization drug delivery device according to claim 1, wherein The temperature and pressure unit includes a liquid medicine heater, a first temperature sensor and a second temperature sensor which are electrically connected to the central control module; The liquid medicine heater is arranged on the high-pressure generating unit and heats the liquid medicine loaded in the high-pressure generating unit to reach the preset temperature of the central control module; The first temperature sensor is used for monitoring the real-time temperature of the liquid medicine, the second temperature sensor is used for monitoring the output temperature of the liquid medicine heater, and transmits the real-time temperature of the liquid medicine and the output temperature data of the liquid medicine heater to the central control module, and the central control module performs closed-loop control on the real-time temperature of the liquid medicine and the liquid medicine heater; And an abdominal cavity heater, a third temperature sensor and a fourth temperature sensor which are electrically connected to the central control module; The abdominal cavity heater is arranged on the abdomen and is used for heating the abdomen and conducting heat to the abdominal cavity gas in the abdominal cavity to raise the temperature of the abdominal cavity gas to the preset temperature of the central control module; The third temperature sensor is used for monitoring the real-time temperature of the abdominal cavity gas, the fourth temperature sensor is used for monitoring the output temperature of the abdominal cavity heater, and transmits the real-time temperature of the abdominal cavity gas and the output temperature data of the abdominal cavity heater to the central control module, and the central control module performs closed-loop control on the real-time temperature of the abdominal cavity gas and the abdominal cavity heater; And an abdominal cavity pressure sensor which is electrically connected to the central control module. The abdominal cavity pressure sensor is used for monitoring the abdominal cavity air pressure and transmitting the abdominal cavity air pressure data to the central control module. The central control module combines with the power unit to control the pressure and flow rate of the atomized liquid medicine ejected by the high-pressure generating unit and the pressure and flow rate of the negative pressure unit for sucking out the abdominal cavity aerosol, so as to cooperatively control the abdominal cavity air pressure in a closed-loop control manner.

17. The abdominal cavity atomization drug delivery device according to claim 1, wherein A limit module, a position detection module and a liquid medicine pressure module which are electrically connected to the central control module are installed on the high-pressure generating unit and perform data interaction; The limiting module is used to obtain the starting position and the final position of the piston, and feedback the data of the starting position and the final position of the piston to the central control module; The position detection module is used to obtain the current position of the piston, feedback the data of the current position of the piston to the central control module, and calculate the current liquid medicine injection amount through the built-in algorithm of the central control module; The liquid medicine pressure module is used to detect the current pressure of the liquid medicine in the high-pressure generating unit, and feedback the data of the current pressure of the liquid medicine to the central control module.

18. The abdominal cavity atomization drug delivery device according to claim 17, wherein A rotation sensor is installed on the power unit, which is used to detect the number of rotation turns and the rotation speed output by the power unit, and feedback the data of the number of rotation turns and the rotation speed output by the power unit to the central control module.

19. The abdominal cavity atomization drug delivery device according to claim 18, wherein The central control module controls the atomization degree and the liquid medicine injection amount of the liquid medicine in a closed-loop control manner by obtaining the starting position, the final position and the current position of the piston, obtaining the data of the current pressure of the liquid medicine in the high-pressure generating unit, and obtaining the data of the number of rotation turns and the rotation speed output by the power unit, and coordinates the power unit, the transmission unit and the high-pressure generating unit.

20. A sterile protective operating sleeve, characterized in that, It includes a sterile operation sleeve and the abdominal cavity atomization drug delivery device according to any one of claims 1 to 19. The sterile protection operation sleeve is sleeved on the abdominal wound, used to isolate the abdominal cavity wound from the external environment, and form a sterile environment in the sterile operation sleeve for the atomization end to extend into the abdominal cavity to be treated in a sterile manner for high-pressure atomization heating drug delivery treatment.

21. A PC - side processor, characterized in that, It includes a PC processing unit and the abdominal cavity atomization drug delivery device according to any one of claims 1 to 19. The PC processing unit is electrically connected to the central control module and conducts data interaction, and is used to receive the drug delivery data set by the user and convert it into interaction data and transmit it to the central control module.

22. An interactor, characterized in that, It includes an operation screen and the PC terminal processor according to claim 21. The operation screen is electrically connected to the PC processing unit and conducts data interaction, and is used to allow the user to set a drug delivery instruction and convert it into an interaction instruction and transmit it to the PC processing unit.

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